Design and Evaluation of Novel Centrifugal Ventricular Assist Devices

Design, Development and Evaluation of
Centrifugal Ventricular Assist Devices

Submitted by

Daniel L. Timms

Bachelor of Mechanical Engineering (Honours)
Queensland University of Technology

A thesis submitted in total fulfilment
of the requirements for the degree of

Doctor of Philosophy

School of Mechanical, Manufacturing and Medical Engineering
Faculty of Built Environment and Engineering

Queensland University of Technology
Brisbane, Queensland, Australia

2005

ii

Keywords
Left- Right- Bi-Ventricular Assist Device, Mock Circulation Loop, Centrifugal Pump
Design, Impeller Hydraulic Force and Performance.

iii
Abstract
Heart disease is the developed world's biggest killer, and the shortage of donor hearts
has accelerated the development of mechanical alternatives.

Scientists, engineers and clinicians have attempted to replicate the human heart with
a mechanical device for over 50 years. Although a number of pulsating devices have
been developed, and in some cases worked briefly, they have invariably failed to
match the success of heart transplantation.

In an attempt to produce a suitable alternative, current research is focused on devices
that do not replace the heart; but rather work along side it to assist its function. Many
of these devices help the failing left ventricle; however some patients require the
additional implantation of a second device to assist a failing right ventricle. This
increases implantation time and associated risk, and because of the size of the current
devices, reduces the access of smaller patients to this vital technology.

The overall thesis objective focuses on the progressive design, development and
preliminary evaluation of two novel centrifugal type ventricular assist devices, a bi-
left ventricular device (Bi-LVAD) and a single bi-ventricular assist device (Bi-
VAD). The devices have the respective capability to assist either the left ventricle, or
both ventricles of a failing heart. The current concept for each VAD employs both
magnetic and hydrodynamic suspension techniques to float a rotating double
impeller, a technique that aims to reduce blood damage and component wear, two of
the major problems encountered with current generation devices.

Each VAD design was developed by conducting experimentation and drawing
conclusions from a variety of engineering research fields, such as flow visualization,
rotary pump design and testing, fluid dynamics, hemodynamics and heart failure, and
magnetic motor bearing design.
iv
In order to evaluate pump prototype designs, it was necessary to design and develop
a novel pulsatile systemic and pulmonary mock circulation loop capable of
reproducing the hemodynamics of heart failure in the systemic and pulmonary
circuits. The investigation then specifically examined the static hydraulic forces on
the impeller of a centrifugal blood pump during operation in this mock circulation
loop. The recorded magnitude and direction of radial and axial thrust then influenced
the selection of magnetic and hydrodynamic bearing configurations to minimise
impeller touchdown in the intended hemodynamic environment. This research
required the development of correctly designed impeller (semi-open/closed) and
volute (single, double, circular) components for each ventricular assist application
and a unique test facility to isolate impeller hydraulic forces in addition to the mock
circulation loop.

The proposed Bi-LVAD incorporates symmetrical blade designs on each side of the
double sided impeller. The device assists the function of the left ventricle only with
symmetrical axial pressure distribution and elimination of stagnant regions beneath
the impeller. These features improve axial touchdown capacity and reduce thrombus
formation respectively. The proposed Bi-VAD incorporates different blade designs
on each side of the double impeller to augment the function of both the left and right
cardiac chambers. The design has the additional potential to act as a total artificial
heart (TAH). To date there is no Bi-VAD/TAH system available that incorporates an
LVAD and RVAD in one rotary pump.

Successful development of each innovative VAD will provide an alternative to heart
transplantation, potentially saving lives of many terminal heart patients each year. No
longer would heart transplant candidates need to wait for the untimely death of a
donor to provide a suitable heart. Instead, this new generation device would be
available immediately, and be almost universally compatible with all patients. It has
the potential to dramatically increase a patients expected lifetime, and to deliver
them a higher quality of life.

v
Table of Contents

Design, Development and Evaluation of Centrifugal Ventricular Assist Devices.. i

Keywords ................................................................................................................... ii

Abstract .................................................................................................................. iii

Table of Contents .........................................................................................................v

List of Figures............................................................................................................. ix

List of Tables ............................................................................................................. xii

Nomenclature ........................................................................................................... xiv

Statement of Authorship............................................................................................xv

Acknowledgements................................................................................................... xvi

Chapter 1 Introduction.......................................................................................... 1-1

1.1 Significance................................................................................................. 1-5
1.2 Objectives.................................................................................................... 1-6
1.3 Aims............................................................................................................ 1-7
1.4 Thesis Outline............................................................................................. 1-8
1.5 Thesis Outcomes and Contributions......................................................... 1-10
1.6 Publications............................................................................................... 1-11

Chapter 2 Literature Review................................................................................. 2-1

2.1 Heart Failure and Treatment Options.......................................................... 2-2
2.2 Ventricular Assist Device Design Considerations...................................... 2-6
2.3 Flow Visualisation.................................................................................... 2-12
2.4 Right Heart Failure and Bi-Ventricular Support....................................... 2-14
2.5 Current Mechanical Assist Devices.......................................................... 2-17
2.6 Design, Performance and Force Characteristics....................................... 2-22
2.7 Magnetic Bearings for Rotary Blood Pumps............................................ 2-36
2.8 Review Summary...................................................................................... 2-45
2.9 Conclusion................................................................................................ 2-49

vi
Chapter 3 Mock Circulation Loop........................................................................ 3-1

3.1 Introduction.................................................................................................3-2
3.2 Background - Description of Physiological Parameters.............................3-2
3.2.1 Circulatory System...................................................................................................3-2
3.2.2 Blood Volume and Pressure Distribution.................................................................3-3
3.2.3 Heart Functionality...................................................................................................3-4
3.2.4 Vascular Hemodynamics..........................................................................................3-6
3.2.5 Physiological Pressures............................................................................................3-7
3.2.6 Compliance.............................................................................................................3-11
3.2.7 Resistance...............................................................................................................3-13
3.2.8 Cardiac Output.......................................................................................................3-16
3.2.9 Cardiac / Vascular Coupling...................................................................................3-19
3.2.10 Autoregulation........................................................................................................3-24
3.3 Literature Review Prototype VAD Testing............................................3-25
3.3.1 Basic Mock Circulation Loops...............................................................................3-25
3.3.2 Advanced Mock Circulation Loops........................................................................3-26
3.3.3 Current Mock Loops...............................................................................................3-26
3.3.4 In-Vivo Reproduction of Heart Failure..................................................................3-34
3.4 Simulation Model of Circulatory System..................................................3-35
3.4.1 Simulation Circulation System Configurations......................................................3-35
3.4.2 Results....................................................................................................................3-37
3.5 Experimental Mock Circulation Loop.......................................................3-39
3.5.1 Design Criteria.......................................................................................................3-39
3.5.2 Description of Mock Circulation Loop...................................................................3-39
3.5.3 Experimental Procedure.........................................................................................3-52
3.5.4 Results....................................................................................................................3-55
3.6 Discussion.................................................................................................3-57
3.6.1 Heart Functionality.................................................................................................3-57
3.6.2 Pressure Distribution..............................................................................................3-60
3.6.3 Vasculature.............................................................................................................3-63
3.6.4 Perfusion.................................................................................................................3-65
3.6.5 Cardiovascular Interaction and Autoregulation......................................................3-66
3.7 Conclusion.................................................................................................3-67

vii
Chapter 4 Centrifugal VAD Design and Development....................................... 4-1

4.1 Introduction................................................................................................. 4-2
4.2 Background................................................................................................. 4-4
4.2.1 Centrifugal Pump Design.........................................................................................4-4
4.2.2 Hydraulic Performance...........................................................................................4-12
4.2.3 Hydraulic Force......................................................................................................4-15
4.3 Design Procedure and Parameter Calculation........................................... 4-32
4.3.1 Design Conditions and Fluid Properties.................................................................4-33
4.3.2 Pump Constants from Similitude............................................................................4-34
4.4 Design Detail............................................................................................. 4-36
4.4.1 LVAD.....................................................................................................................4-36
4.4.2 RVAD.....................................................................................................................4-37
4.4.3 Bi-LVAD................................................................................................................4-38
4.4.4 Bi-VAD..................................................................................................................4-39
4.5 Discussion................................................................................................. 4-40
4.6 Conclusion................................................................................................ 4-41

Chapter 5 VAD Experimental Evaluation........................................................... 5-1

5.1 Introduction................................................................................................. 5-1
5.2 Experimental Method.................................................................................. 5-3
5.2.1 Prototype Pump Construction...................................................................................5-4
5.2.2 Equipment / Instrumentation / Software / Code.......................................................5-5
5.2.3 Experimental Design................................................................................................5-7
5.2.4 Experimental Procedure...........................................................................................5-9
5.2.5 Calibration..............................................................................................................5-11
5.2.6 Experimental Configurations..................................................................................5-13
5.3 Results....................................................................................................... 5-15
5.3.1 Non-Pulsatile..........................................................................................................5-15
5.3.2 Pulsatile..................................................................................................................5-26
5.4 Discussion................................................................................................. 5-26
5.4.1 Experimental Method.............................................................................................5-26
5.4.2 Non-Pulsatile Operation.........................................................................................5-26
5.4.3 Pulsatile Operation.................................................................................................5-26
5.4.4 Application to Bearing System Design...................................................................5-26
5.5 Conclusion................................................................................................ 5-26
5.5.1 Force and Performance...........................................................................................5-26
5.5.2 Bearing Design.......................................................................................................5-26
viii
Chapter 6 VAD Design Summary....................................................................... 6-26

6.1 Introduction...............................................................................................6-26
6.2 Bi-LVAD...................................................................................................6-26
Overview ................................................................................................................................6-26
6.3 Bi-VAD.....................................................................................................6-26
Overview ................................................................................................................................6-26

Chapter 7 Conclusions and Future Research .................................................... 7-26

7.1 Conclusions...............................................................................................7-26
7.1.1 Literature Review...................................................................................................7-26
7.1.2 Mock Circulation Loop..........................................................................................7-26
7.1.3 Centrifugal VAD Design and Development...........................................................7-26
7.1.4 VAD Experimental Evaluation...............................................................................7-26
7.1.5 VAD Design Detail ................................................................................................7-26
7.2 Future Research.........................................................................................7-26
7.2.1 Mock Circulation Loop..........................................................................................7-26
7.2.2 Centrifugal VAD Development..............................................................................7-26

Appendices
Appendix A - A Survey of Current Mechanical Assist Devices
Appendix B - Centrifugal VAD Design
Appendix C - Impeller Hydraulic Force Calculation
Appendix D - SIMULINK and MATLAB Code
Appendix E - Calibrations
Appendix F - Magnetic Bearing Investigation
Appendix G - VAD Design Detail

References
ix
List of Figures
Figure 2-1 Inlet (Left) and Outlet (Right) Devices.........................................................................2-27
Figure 2-2 Double Volute Configuration........................................................................................2-28
Figure 2-3 - Non-Dimensional Performance of Rotary Blood Pumps.............................................2-29
Figure 2-4 Experimental Measurement of Radial Thrust Magnitude and Direction......................2-35
Figure 2-5 Values of Radial Force Factor (K) for Eccentrically Located Impellers in a Concentric
Casing...............................................................................................................................................2-35
Figure 2-6 Monopivot Magnetic Suspension Pump.......................................................................2-38
Figure 2-7 Radial Restoration Using Permanent Magnets.............................................................2-38
Figure 2-8 Radial Magnetic Motor-Bearing...................................................................................2-39
Figure 2-9 Principle of Passive Restoring Force............................................................................2-40
Figure 2-10 Axial Magnetic Motor-Bearing..................................................................................2-41
Figure 3-1 Circulatory System.........................................................................................................3-3
Figure 3-2 Circulatory Pressure Distribution...................................................................................3-3
Figure 3-3 Phases and Pressure for one Cardiac Cycle...................................................................3-4
Figure 3-4 Pressure Distribution within the Chambers of the Heart (Rest)......................................3-8
Figure 3-5 Left Heart Pressure Distribution.....................................................................................3-8
Figure 3-6 Systemic Pressure Distribution.....................................................................................3-10
Figure 3-7 Pulmonic Pressure Distribution....................................................................................3-10
Figure 3-8 Compliance (systole and diastole)................................................................................3-11
Figure 3-9 Definition of Compliance.............................................................................................3-11
Figure 3-10 Development of Ventricular Stroke Volume..............................................................3-16
Figure 3-11 Effect of Volume, Vascular Compliance and Resistance on P
RA
...............................3-20
Figure 3-12 Cardiac Function Curves............................................................................................3-21
Figure 3-13 Interaction between Cardiac and System Function Curves........................................3-21
Figure 3-14 Compensatory mechanisms in response to heart failure...........................................3-21
Figure 3-15 Basic Test Loop..........................................................................................................3-25
Figure 3-16 Advanced Mock Circulation Loop.............................................................................3-26
Figure 3-17 (Pantalos, Koenig et al. 2004) Mock Circulation Loop..............................................3-27
Figure 3-18 (Wu, Allaire et al. 2004) Mock Circulation Loop.......................................................3-27
Figure 3-19 ASTM F1841Test Loop (ASTM_F1841-97 1998)....................................................3-33
Figure 3-20 SIMULINK Model for Complete Circulation............................................................3-35
Figure 3-21 Resting Pressure Distribution.....................................................................................3-36
Figure 3-22 Left Heart Failure Pressure Distribution...................................................................3-36
Figure 3-23 Resting Perfusion........................................................................................................3-36
Figure 3-24 Left Heart Failure perfusion.......................................................................................3-36
Figure 3-25 Mock Circulation Rig.................................................................................................3-38
Figure 3-26 Top View Mock Circulation Loop with listed parameters.........................................3-40
Figure 3-27 Structural components of the simulated beating heart................................................3-41
x
Figure 3-28 Control and monitor of cardiac function.................................................................... 3-42
Figure 3-29 Compliance Chamber................................................................................................. 3-45
Figure 3-30 Proportional Pinch Valve........................................................................................... 3-45
Figure 3-31 Electromagnetic Flowmeter........................................................................................ 3-48
Figure 3-32 Experimental Technique............................................................................................. 3-50
Figure 3-33 Pressure distribution throughout the vascular tree for systemic (a) and pulmonic (b)
circulation` systems for resting conditions........................................................................................ 3-54
Figure 3-34 Pressure distribution throughout the vascular tree for systemic (a) and pulmonic (b)
circulation systems for heart failure conditions. ............................................................................... 3-54
Figure 3-35 Perfusion Rate for Rest............................................................................................... 3-54
Figure 3-36 Perfusion Rate for Left Heart Failure........................................................................ 3-54
Figure 3-37 Systemic Pressure Distribution (Exercise) ................................................................. 3-56
Figure 3-38 - Perfusion Rate for systemic circulation (Exercise) ..................................................... 3-56
Figure 4-1 Volute velocity assuming constant momentum (a) and constant velocity (b) ................ 4-8
Figure 4-2 Volute Configurations................................................................................................. 4-9
Figure 4-3 Types of volute cross sections...................................................................................... 4-10
Figure 4-4 Volute design parameters (Lazarkiewicz and Troskolanski 1965)............................... 4-11
Figure 4-5 Taper Angle Vs Throat Velocity.................................................................................. 4-11
Figure 4-6 - Non-Dimensional Performance for Different Discharge Blade Angles....................... 4-12
Figure 4-7 Variations in Static Radial Thrust of Common Volute Types...................................... 4-16
Figure 4-8 Single Volute Fluid Velocity at Various Flow Conditions (Q). ................................... 4-17
Figure 4-9 - Radial Thrust Direction at Operation Below Design Capacity..................................... 4-18
Figure 4-10 - Radial Thrust Direction at Operation Above Design Capacity................................... 4-19
Figure 4-11 Flow Separation Regions in a Double Volute at Part Capacities................................ 4-20
Figure 4-12 Modified Concentric Volute....................................................................................... 4-21
Figure 4-13 - Radial Thrust Direction for Single Volutes................................................................. 4-23
Figure 4-14 Variations in Static Axial Thrust in all Volute Types................................................ 4-25
Figure 4-15 Variations in Static Axial Thrust in an Closed Type Impeller.................................... 4-26
Figure 4-16 Variations in Static Axial Thrust in a Semi-Open Type Impeller............................... 4-26
Figure 4-17 Techniques for Balancing Axial Thrust...................................................................... 4-27
Figure 4-18 LVAD Pump.............................................................................................................. 4-37
Figure 4-19 RVAD Pump.............................................................................................................. 4-37
Figure 4-20 Bi-LVAD Pump......................................................................................................... 4-38
Figure 4-21 Bi-VAD Pump............................................................................................................ 4-39
Figure 5-1 Experimental Process Diagram...................................................................................... 5-2
Figure 5-2 Force Test Rig................................................................................................................. 5-8
Figure 5-3 Pressure Tapping Locations........................................................................................... 5-9
Figure 5-4 Experimental VAD configurations............................................................................... 5-12
Figure 5-5 LVAD Family of Pump Performance and Efficiency Curves..................................... 5-14
Figure 5-6 LVAD Performance with Constant Speed and Axial Clearance Variation.................. 5-16
Figure 5-7 LVAD Non-Dimensional Pump Performance Curves.................................................. 5-17
xi
Figure 5-8 LVAD Non-Dimensional Power Curves......................................................................5-18
Figure 5-9 RVAD Family of Pump Performance Curves..............................................................5-19
Figure 5-10 RVAD Non-dimensional Pump Performance Curves................................................5-19
Figure 5-11 Radial Thrust in single (a), double (b) and circular (c) volutes. .................................5-21
Figure 5-12 Radial Thrust Direction & Magnitude Integrated from Single Volute Pressures Readings
at Shut-off, Design and Maximum Flow Capacities. ........................................................................5-22
Figure 5-13 Axial Thrust on Impeller Types..................................................................................5-23
Figure 5-14 Comparison of Axial Thrust in a Semi-Open single and double impeller..................5-23
Figure 5-15 Reaction Torque in Single Volute (22.5)....................................................................5-24
Figure 5-16 Comparison of measured Radial thrust with theoretical prediction............................5-25
Figure 5-17 Comparison of measured axial thrust with theoretical prediction..............................5-26
Figure 5-18 Direction of Radial Thrust in Single, Double and Circular Volutes at 2400rpm........5-26
Figure 5-19 Radial thrust direction of comparative specific speeds in a single volute..................5-26
Figure 5-20 Untreated heart failure pressure for systemic (i) and pulmonary (ii) circulation........5-26
Figure 5-21 LVAD supported pressure for systemic (i) and pulmonary (ii) circulation...............5-26
Figure 5-22 Transition of perfusion from Heart Failure to LVAD Support...................................5-26
Figure 5-23 Non-Pulsatile LVAD operation in the pulsatile LHF environment............................5-26
Figure 5-24 Non-Pulsatile LVAD efficiency in the pulsatile LHF environment...........................5-26
Figure 5-25 Fluctuation of force with systole and diastole............................................................5-26
Figure 5-26 Forces from pulsatile and non-pulsatile test results.....................................................5-26
Figure 5-27 Systemic (a) and Pulmonic (b) BI-HF pressure distribution.......................................5-26
Figure 5-28 Systemic (a) and Pulmonic (b) BI-VAD supported pressure distribution.................5-26
Figure 5-29 Perfusion Rate for Rest...............................................................................................5-26
Figure 5-30 Perfusion Rate for Left Heart Failure. .......................................................................5-26
Figure 5-31 Pulsatile Hydraulic LVAD Performance in Various Heart Function Situation..........5-26
Figure 6-1 Exploded View of Bi-LVAD Design............................................................................6-26
Figure 6-2 Schematic Cross Sectional View of the Bi-LVAD design..........................................6-26
Figure 6-3 Perspective View of the Bi-LVAD Design...................................................................6-26
Figure 6-4 Exploded View of Bi-VAD Design..............................................................................6-26

xii
List of Tables
Table 2-1 - The index of hmolysis of blood pumps.......................................................................... 2-8
Table 2-2 Current Mechanical Assist Devices............................................................................... 2-18
Table 2-3 Dimensionless Coefficients........................................................................................... 2-29
Table 2-4 Comparison of Self Bearing Motor Operations Characteristics..................................... 2-43
Table 3-1 Blood Volume Distribution............................................................................................. 3-3
Table 3-2 Resting Pressure Distribution throughout the Vascular Tree......................................... 3-10
Table 3-3 Mean Circulatory Pressures for Rest/LHF/Exercise....................................................... 3-10
Table 3-4 Arterial Compliance....................................................................................................... 3-12
Table 3-5 Venous Compliance....................................................................................................... 3-13
Table 3-6 Systemic Vascular Resistance........................................................................................ 3-14
Table 3-7 Pulmonic Vascular Resistance........................................................................................ 3-15
Table 3-8 Parameter affecting cardiac output................................................................................ 3-17
Table 3-9 Properties of Pumping Mediums................................................................................... 3-32
Table 3-10 Valve Settings for Various Circulation Configurations............................................... 3-41
Table 3-11 Chamber characteristics for Resting Compliance Values............................................ 3-45
Table 3-12 Mock Circulation Rig Component Inherent Resistance Values................................... 3-45
Table 3-13 Physiological flow conditions...................................................................................... 3-48
Table 3-14 Mock Circulation Loop Parameter............................................................................... 3-52
Table 3-15 Comparison of Mock Circulation Loop Pressure Results............................................ 3-60
Table 3-16 Systemic (SVR) and Pulmonary (PVR) Resistance Comparison................................ 3-63
Table 3-17 Systemic (SAC) and Pulmonary (PAC) Compliance Comparison.............................. 3-63
Table 3-18 Comparison of Mock Circulation Loop Perfusion Results.......................................... 3-65
Table 4-1 Fluid Properties.............................................................................................................. 4-33
Table 4-2 Design Output Pressure................................................................................................. 4-33
Table 4-3 - Design Flow Rates.......................................................................................................... 4-33
Table 4-4 Reynolds Number (Re).................................................................................................. 4-34
Table 4-5 Specific Speed (N
s
)........................................................................................................ 4-35
Table 4-6 Specific Capacity (q
s
) .................................................................................................... 4-35
Table 4-7 Specific Head (h
s
).......................................................................................................... 4-35
Table 4-8 LVAD Impeller and Volute Configurations.................................................................. 4-36
Table 4-9 RVAD Impeller and Volute Configurations.................................................................. 4-37
Table 4-10 Bi-LVAD Impeller and Volute Configurations........................................................... 4-38
Table 4-11 Bi-VAD Impeller and Volute Configurations.............................................................. 4-39
Table 5-1 LVAD Impeller/Volute Experimental Configurations................................................... 5-13
Table 5-2 RVAD Impeller/Volute Experimental Configurations.................................................. 5-13
Table 5-3 BVAD Impeller/Volute Experimental Configurations.................................................. 5-13
Table 5-4 - Design Point Rotational Speed (RPM) of LVAD Impeller/Volute Configurations....... 5-15
Table 5-5 - Design Point Rotational Speed (RPM) of RVAD Impeller/Volute Configurations....... 5-20
xiii
Table 5-6 Radial trust at design point (5L/min @ 100mmHg).......................................................5-22
Table 5-7 Axial thrust at design point............................................................................................5-23
Table 5-8 Comparison of Heart Failure to LVAD Support Component Pressures........................5-26
Table 5-9 Pressure and flow conditions for diastolic and systolic periods.....................................5-26
Table 5-10 LVAD Support Force/Torque Magnitudes at Systole and Diastole.............................5-26
xiv
Nomenclature

AMB Active Magnetic Bearing LVP Left Ventricular Pressure
A
1
,A
wr
Impeller Inner Diameter Area LVP
ED

Left Ventricular End Diastolic
Pressure
A
2
, A
3
Impeller Outer Diameter Area MAP Mean Arterial Pressure
A
B
Area exposed back shroud pressure MPAP Mean Pulmonary Arterial Pressure
A
e
Impeller Eye Area MSCBP Magnetically Suspended Centrifugal
Blood Pump
A
F
Front Shroud N
s
Specific Speed
A
s,
A
sh
,
A
h

Shaft Area P Pressure (Head)
AoC Aortic Compliance PAC Pulmonary Arterial Compliance
AoP Aortic Pressure PAP Pulmonary Arterial Pressure
A
th
Throat Area PP Pulse Pressure
B Magnetic Field Strength PRU Pulmonary Resistance Units
BEP Best Efficiency Point PVC Pulmonary Venous Compliance
Bpm Beats per Minute PVP Pulmonary Venous Pressure
b
1
Inlet Blade Height PVR Pulmonary Vascular Resistance
b
2
Outlet Blade Height P
1
Pressure at Inner Diameter
B
2
Impeller Width including shrouds P
D
Head, Discharge Pressure
C Compliance P
dias
Diastolic Pressure
Ca Arterial Compliance P
mc
Mean Circulatory Pressure
CI Cardiac Index P
s
, p
s
Suction Pressure
CO Cardiac Output P
sys
Systolic Pressure
CPB Cardio-pulmonary Bypass Q Flow Rate (Capacity)
CVP Central Venous Pressure Q
n
Normal Capacity (B.E.P)
c
1
Fluid Inlet/Eye Velocity q
s
Specific Capacity
c
m2
Meridional Outlet Velocity R Resistance
C
o
Fluid Inlet/Eye Velocity RAP Right Atrial Pressure
c
u1
Inlet Tangential Velocity RVP Right Venous Pressure
c
u2
Outlet Tangential Velocity SV Stroke Volume
c
u3
Throat Velocity SVC Systemic Venous Compliance
Cv Venous Compliance SVP Systemic Venous Pressure
D
1
Impeller Inlet Diameter SVR Systemic Vascular Resistance
D
2
Impeller Outlet Diameter T Net/Resultant Axial Thrust
D
3
Base Circle Diameter T
a
Net/Resultant Axial Thrust
EDV End Diastolic Volume TPR Total Peripheral Resistance
ESV End Systolic Volume u
2
Outer Diameter Peripheral Velocity
F Momentum change force u
sh,
u
s
Shaft Peripheral Velocity
F
T
Net/Resultant Axial Thrust u
wr
Inner Diameter Peripheral Velocity
F
r
Radial Force (lbf) VR Venous Return
H Head, Discharge Pressure
HR Heart Rate
H
p
Head, Discharge Pressure
H
v
Pressure at Inner Diameter
h
s
Specific Head
2
Actual Fluid Discharge Angle
I Current in Coil
v
Volute Spiral Angle
K Radial Thrust Factor
1
Impeller Inlet Angle
K
Avb
Avg % pressure on Back Shroud
2
Impeller Discharge Angle
K
Avf
Avg % pressure on Front Shroud p Developed Impeller Pressure
K
th
Radial Thrust Factor Diffuser Angle
L Effective length of wire , sp.gr Specific Gravity (1.0 for water)
LAP Left Atrial Pressure
LHF Left Heart Failure

xv
Statement of Authorship
The work contained in this thesis has not been previously submitted for a degree or
diploma at any other higher education institution. To the best of my knowledge and
belief, the thesis contains no material previously published or written by any other
person except where due reference is made.

Daniel Timms
2005
xvi
Acknowledgements
I would first like to acknowledge the unrelenting and invaluable support of my
parents. The completion of this research is a testament to their support throughout
my entire candidature, from brainstorming sessions with my father to the use of our
growing home workshop. The significance of this field was highlighted after the
repair and eventual replacement of his mitral valve in 2004 by the Transplant
Services Department of the Prince Charles Hospital, the team with which research
collaboration was achieved at the commencement of the project.
I cannot describe the extent to which my gratitude is extended to the Mechanical
Engineering Electronics Technician, Mark Hayne. His job description does not begin
to pay justice to the range of contributions made to assist in my successful
completion. Countless hours were spent milling over the workshop whiteboard,
which were crucial to the identification of research avenues to pursue. His knack at
pointing out the bright side was an appreciated characteristic essential for my ability
to face, and then overcome adversities.
To my supervisor, Andy Tan, for his enthusiasm in an exciting field of research. His
supervision ultimately led to the unconstrained experimentation required for the
development of new designs.
To Mark Pearcy, the ever present leader of Medical Engineering Research at QUT,
who possesses the ability to critically apply engineering principles to all fields of
research. My future career will be no doubt influenced by the goal of trying to
experience success to a similar magnitude.
Appreciation is also extended to Keith McNeil, Andrew Galbraith and colleagues at
the Prince Charles Hospital for their consistent and unrelenting enthusiasm about the
project as a whole. The supply of research funding was critical in the development
of prototype pumps and mock circulation testing facility.
xvii
I have been fortunate enough to have had the support of close friends and assistance
from colleagues throughout my candidature. I wish to extend sincere thanks to the
following people:

Lydia Balzat for her inspiring attitude and support throughout my
candidature,
Katie McNickle for the work ethic developed in undergrad that led to the
opportunity to tackle postgraduate studies,
Nicky McAllister, for a part-time job that provided financial security as well
as an environment suitable for countless hours of extra research,
Andrew Cliffe for his assistance in the flow visualisation experimentation,
Aaron Cahill, Ben Breise, Noboyuki Kurita and Takahito Tokomoto for their
work and valuable assistance with the various magnetic bearing
configurations,
Professor Yohji Okada, for the opportunity to study Magnetic Bearings in his
laboratory for 3 months in 2001,
Peter Ridley for his experience in control used in the development of the
Mock Loop simulation,
Wim Dekkers for his expertise in fluid dynamics.

My initial interests in medical devices stemmed from my undergraduate studies in
medical engineering. Although my degree was completed in Mechanical
Engineering, there was little doubt I would once again ply my learned engineering
skills to the pursuit of improving quality of life. For this, I must again thank my
supervisor, Andy Tan, for the opportunity to pursue cardiac assist devices at QUT.
The team of researchers developed, and funding attracted since the projects inception
is a tribute to each individual mentioned for assisting and contributing to the ultimate
goal of a viable artificial heart.
Chapter 1 - Introduction

1-1
Chapter 1
Introduction

Heart disease is the developed worlds biggest killer, with over 800,000 new cases
reported each year. Unfortunately, less than 3000 heart transplant procedures are
performed annually due to a shortage of donor hearts (Rose, Gelijns et al. 2001). This
predicament has accelerated the development of mechanical circulatory assistance as
an alternative treatment.

Studies have revealed that patients receiving mechanical devices to assist a failing
left ventricle have extended lives and improved quality of life compared to recipients
of optimal drug therapy. However, these patients succumb to various ailments
associated with currently approved pulsatile type devices inside two years (Rose,
Gelijns et al. 2001). Therefore, current research is focused on third generation
continuous flow rotary pumps that employ magnetic or hydrodynamic techniques to
suspend the impeller within the pump casing (Baloh, Allaire et al. 1999; Watterson,
Woodard et al. 2000). These systems reduce blood damage, component wear and
potentially increase device lifetime beyond 10 years.

This thesis outlines the design and progressive development of two novel, third
generation, continuous flow, double sided centrifugal impeller pumps; a bi-left
ventricular assist device (Bi-LVAD) and single bi-ventricular assist device (Bi-
VAD). The Bi-LVAD is designed to assist the function of the left ventricle only,
while the single Bi-VAD simultaneously augments the function of both left and right
ventricles of patients suffering bi-ventricular heart failure. Alternative techniques for
the latter condition require the implantation of two devices in such patients (Nose
and Furukawa 2004), increasing overall system size and reducing the access of
women and children to this vital technology.

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Magnetic and hydrodynamic bearing techniques were identified to suspend the
double sided impeller in each miniature centrifugal type device, thus overcoming
conventional pump limitations of friction and wear at the drive shaft, seal and
bearing interface. This will greatly increase the durability of the pump and reduce
both heat generation and red blood cell damage. Complete impeller suspension
requires the generation of bearing forces to overcome the dynamic and static
disturbance forces experienced during operation. By designing the bearing with
sufficient load capacity, the incidence of impeller touchdown can be minimised.
Furthermore, the reduction of static load will reduce the power requirements of the
magnetic bearing system to maintain the impeller in a central position.

Although the final designs are still subject to iterative refinement, this thesis
describes the processes undertaken to develop each device to their current stage.
Progressive experimentation was conducted and conclusions drawn from a number
of medical and engineering fields, such as flow visualization, hemodynamics and
heart failure, rotary pump design and testing, and magnetic motor bearing design.

The requirement for in-vitro device evaluation prompted the design and construction
of a new systemic and pulmonary mock circulation loop, including pulsatile left and
right ventricles coupled with vascular compliances and resistances. Since most VAD
centers focus on left ventricular assistance, no mock circulation loop existed that
could test the function of left and/or right assistance. The custom developed loop
was therefore designed to replicate the hemodynamic conditions of the entire
cardiovascular system in response to normal heart function and varying levels of left
and/or right heart failure. This was achieved by exclusively controlling
hemodynamic parameters such as heart function (rate, contractility) and vascular
tone (resistance, compliance), a feature not exclusively afforded in an in-vivo setting.
This small and compact rig provides the ability to evaluate the hemodynamic effect
of Left-, Right and Bi- ventricular assist devicein-vitro. It has the potential to reduce
device evaluation costs by simulating the natural circulatory system, and thus
provide valuable cardiovascular device performance feedback prior to monetary and
time expensive and in-vivo animal trials.

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A centrifugal pump design procedure was then formulated to design the components
of each VAD. A number of single sided impeller/volute configurations were
constructed as individual left and right components of the Bi-VAD design, to
produce the required pressure and flow performance to assist the systemic and
pulmonary circulatory systems.

The performance of a rotary blood pump is gauged by the success of the device to re-
establish cardiovascular hemodynamic parameters (pressure and flow) from
pathological to normal levels. This capability is determined by the pump
performance characteristic curves. The gradient of the curve influences the response
of the device to changing physiological conditions (exercise, rest, etc).

Device operation results in a fluid pressure distribution within the pump casing,
which if unbalanced, lead to axial and radial hydraulic thrust acting on the impeller.
A unique method for measuring the magnitude and direction of impeller static
hydraulic thrust during device operation was therefore developed. Force
characteristics are valuable for impeller suspension design of third generation
magnetic or hydrodynamic bearing devices. Specifically, the force magnitude
determines the required magnetic or hydrodynamic forces to keep the impeller
central, and minimise contact with the casing.

Each of the constructed LVAD and RVAD components were inserted into the mock
circulation loop configured for non-pulsatile operation, to record performance
characteristic curves. An LVAD configuration was then inserted into the loop
configured for left heart failure to assess its ability to reduce pulmonary congestion,
and restore perfusion levels from pathological to normal levels. Impeller force
characteristics were simultaneously recorded during all tests involving each LVAD
configuration. The influence of failing heart pulsatility on the magnitude and
direction of these hydraulic forces was determined


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The results presented in this thesis are used to recommend the appropriate
impeller/volute configurations for designs incorporating magnetic, hydrodynamic
and mechanical type bearings to increase device lifetime. The force information was
then specifically used as criteria for magnetic motor-bearing investigations, to
determine a suitable configuration for incorporation in each of the proposed Bi-
LVAD and Bi-VAD designs.

Finally, the research conducted and conclusions drawn in the thesis were used to
design the current Bi-LVAD and Bi-VAD concepts. The proposed Bi-LVAD
incorporates symmetrical blade profiles on each side of the magnetically suspended
double impeller. The device assists the function of the left ventricle only with
symmetrical axial pressure distribution and elimination of stagnant regions beneath
the impeller. These features improve axial touchdown capacity and reduce thrombus
formation respectively. The proposed Bi-VAD incorporates different blade designs
on each side of the magnetically and hydrodynamically suspended double impeller,
to augment the function of both the left and right cardiac chambers.


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1.1 Significance
The significance of this research relates to the development of two novel centrifugal
heart assist devices. These miniature devices can afford smaller patients access to
VAD technology, potentially saving many lives each year.
Successful development of these innovative VADs will provide an alternative to
heart transplantation plantation for many cardiac patients worldwide. No longer
would these patients need to wait for the untimely death of a donor to provide a
suitable heart. Instead, these latest generation devices would be available
immediately, and be almost universally compatible. They have the potential to
dramatically increase a patients expected lifetime, and to deliver them a higher
quality of life. This translates to a renewed ability to leave the confines of the
hospital and return to daily activities. Furthermore, this situation can potentially ease
the strain on worldwide health care systems caused by cardiovascular disease, as
hospitalisation costs may be reduced, or reallocated to other critical care. Patients can
be transferred from expensive Intensive Care Units to Wards, and ultimately to the
comfort of their own home. VAD therapy can also reduce the use of expensive and
continuous pharmaceuticals, in the form of immunosuppressant drugs associated
with open heart transplantation, and BETA Blockers/ACE inhibitors related to heart
failure treatment.
The development of a mock circulation loop that has the capability of reproducing
the hemodynamics of a patient experiencing a range of cardiovascular diseases will
provide valuable insights into each cardiovascular device performance prior to in-
vivo trials and human implantation.
The identification and characterisation of static hydraulic force on a VAD impeller
operating in a pulsatile environment will help to determine the required magnetic or
hydrodynamic bearing load capacity to minimise impeller touchdown. By
investigating numerous impeller and volute configurations, the most appropriate
combination may be selected to suit each bearing design.

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1.2 Objectives
The main objective of this thesis was to describe the design, development and
evaluation process of two novel rotary type ventricular assist devices, a Left
Ventricular Assist Device (LVAD) and Bi-Ventricular Assist Device (Bi-VAD).

The development of a pulsatile mock cardiovascular loop was specifically required to
achieve the secondary objective of static hydraulic force measurement on the
impeller of a centrifugal blood pump. A suitable test facility was then required to
isolate impeller forces in the pulsatile operating environment, to determine the
required bearing load capacity to minimise impeller touchdown and reduce magnetic
bearing power.

Substantial clinical input was merged with engineering principles for the purpose of
creating this cardiovascular test rig to reproduce the pulsatile human cardiovascular
system. This mock circulation loop was required to investigate clinical circulatory
hemodynamics in response to a variety of acute or chronic heart failure conditions,
by recreating their symptomatic effect on hemodynamic parameters (vascular
resistance, contractility, heart rate). Ultimately, the objective of this rig was to
facilitate VAD testing prior to in-vivo animal and clinical trials, by assessing the
devices ability to return the circulatory hemodynamics to normal conditions.


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1.3 Aims
The specific aims of this thesis are described with reference to each chapter:
Literature Review
1. The review of the literature aimed to detail the requirements for VAD design
and support the pursuit of Bi-Ventricular assistance.
2. Research into active magnetic motor-bearings aimed to provide characteristic
information about each configuration type (radial and axial), such as max
load capacity in the supported DOF, efficiency and rotational speed.
3. The flow visualisation background research attempted to highlight regions for
potential blood trauma in centrifugal blood pumps.
Mock Circulation Loop
1. To design and construct a systemic and pulmonary mock circulation loop that
could recreate the hemodynamic conditions of a normal and failing heart at
rest.
2. To create a computer simulation model to validate and assist in the design,
construction and validation of the invitro circulation loop.
Centrifugal VAD Design and Development
1. To produce a customized method for VAD design iterations
2. To create a number of impeller and volute configurations for evaluation.
VAD Experimental Evaluation
1. To identify the pump performance and force characteristics of each
impeller/volute configuration in non-pulsatile and pulsatile mock circulation
loops.
2. To select the best pump impeller/volute configurations to both improve
performance within the cardiovascular environment, and magnetic bearing
load capacity to minimise impeller touchdown.
VAD Design Detail
1. To provide a detailed discussion of each VAD design using the results
obtained and conclusions drawn from the preceding chapters.

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1.4 Thesis Outline
This thesis is presented in six chapters describing the design and progressive
development of two ventricular assist devices with the aid of a suitable mock
circulation loop to evaluate their performance in an in-vitro pulsatile heart failure
environment.
Chapter 2 continues with a review of the literature and background research into this
emerging field, allowing the reader to understand and appreciate the importance of
cardiac assist device development, and the niche that the proposed designs occupy.
Within this review, the design criteria for each VAD, from potential blood damaging
effects to the hemodynamic requirements of the device, are discussed.
A summary of two background research topics are also included in this chapter. The
findings from a study on magnetic motor bearing technology outline the possible
suspension configurations for incorporation in both LVAD and Bi-VAD
applications, while the flow visualisation information attempts to highlight the
general regions of potential blood trauma in centrifugal blood pumps.
A suitable testing facility was required to evaluate the performance of each VAD
design configuration. A complete mock circulation loop, including systemic and
pulmonary circuits in series, was constructed and detailed in Chapter 3. This rig
incorporated passive filling atria and pneumatically actuated ventricles with the
ability to alter function in order to simulate the hemodynamic conditions of varying
degrees of left and/or right heart failure. A first order SIMULINK computer model of
the circulation system was also simultaneously developed to assist in rig construction
as well as result verification.
Chapter 4 then presents the components required for centrifugal pump design. A
variety of methods were amalgamated in Appendix B to produce a custom procedure
used to design the first and future VAD impeller and volute iterations . A number of
volute and impeller configurations were designed with the intention of evaluating
each and selecting the most suitable for inclusion in each final VAD design. The Bi-
VAD was initially designed as two single LVAD and RVAD pumps, under the
premise that results obtained from these configurations will assist in the final
iteration design. Details of these individual designs conclude the chapter.

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With the proposed method of impeller suspension relying on magnetic force
generation to levitate the impeller within the pump cavity, the magnitude of these
force requirements should be ascertained in order to complete the bearing design.
Knowledge of the expected magnitudes in each degree of freedom determines the
required bearing load stiffness to minimise impeller touchdown.
The assessment of impeller force and performance characteristics experienced by
each impeller/volute configuration is conducted in Chapter 5. Impellers of varying
discharge angle were supported within the single, double and circular volute casings
by a conventional shaft, seal and bearing system assembly, and driven by a small
electric motor.
Performance characteristics were measured initially in a non-pulsatile mock
circulation environment, before the hemodynamic effect of VAD insertion in the
complete pulsatile mock circulation rig experiencing left heart failure, such as the
relief of pulmonary congestion and return of sufficient perfusion was assessed.
Particular focus was placed on the impeller discharge angle and axial actuation of the
semi-open type impeller
Simultaneous measurement of radial (x,y) and axial (z) hydraulic forces imposed on
the impeller by differential hydraulic pressures within the volute casing was also
undertaken. The results were then matched to force calculation equations to
theoretically predict axial and radial thrust for VAD designs. This information is
crucial for the impeller suspension design to minimise impeller touchdown.
Consequent recommendations are made for suitable impeller/volute configurations
for magnetic, hydrodynamic and mechanical bearing suspension.
Chapter 6 summarises the current VAD designs, taking into consideration
conclusions drawn from the research presented in the thesis. Functionality is
discussed while advantages and disadvantages are critically provided to assess the
capability of each VAD to accomplish the task of ventricular assistance.
The thesis is concluded in Chapter 7 by addressing the thesis aims, and summarising
and reiterating the chapter contributions to each specific VAD design.


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1.5 Thesis Outcomes and Contributions
The work presented in this thesis describes a significant development in the design
and in-vitro testing of ventricular assist devices, and encompasses new and
innovative concepts that have led to:
1. Two novel ventricular assist device design concepts that include;
a. A Bi-LVAD device incorporating a double suction centrifugal
impeller.
b. The combination of a rotary LVAD and RVAD into a single impeller
Bi-VAD device.
2. The development of a model simulation and physical complete pulsatile
systemic and pulmonary mock circulation loop which;
a. Can simulate the effect of varying levels of heart disease on the
systemic and pulmonary circulatory system.
b. Is suitable for evaluating the hemodynamic performance of
cardiovascular devices.
3. A design procedure to develop centrifugal type ventricular assist devices
which
a. is an amalgamation of various pump design recommended procedures
b. provides a step by step outline for the design of each component
4. A unique method for measuring hydraulic forces in impeller/volute
configurations, with the results used to;
a. Determine the load requirements of magnetic or hydrodynamic
bearings to minimise impeller touchdown in a pulsatile environment.
b. Suggest the most appropriate bearing configuration for each design.
c. Select the most appropriate empirical formula for hydraulic force
prediction.


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1.6 Publications
The full text of each publication listed below is located on the accompanying CD-
ROM.
1.6.1 Peer Reviewed Journal Publications
Timms, D.L., M. Hayne, A. Galbraith, and K. McNeil, A Complete Mock
Circulation Loop for the Evaluation of Left- Right- and Bi- Ventricular Assist
Devices. Artificial Organs, 2005. 29(7): p. 564571.
Timms, D.L., M. Hayne, A.C.C. Tan, and M.J . Pearcy, LVAD Pump Performance
And Force Characteristics In A Pulsatile Complete Mock Circulation Loop. Artificial
Organs, 2005. 29(7): p. 572-580
Timms, D.L., A.C.C. Tan, M.J . Pearcy, K. McNeil, and A. Galbraith, Hydraulic
Force and Impeller Evaluation of a Centrifugal Heart Pump. J ournal of the Korean
Society of Marine Engineers, 2004. 28(2): p. 376-381.
Tan, A.C.C., D.L. Timms, M.J . Pearcy, K. McNeil, and A. Galbraith, Experimental
Flow Visualisation of an Artificial Heart Pump. J ournal of the Korean Society of
Marine Engineers, 2004. 28(2): p. 210-216.
1.6.2 Published Conference Proceedings
Tokumoto, T., D.L. Timms, H. Kanebako, K. Matsuda, and Y. Okada. Development
of Lorentz Type Self Bearing Motor. in 8th International Symposium on Magnetic
Bearings. 2002. Mito, J apan.
Timms, D.L. and A.C.C. Tan. Flow Visualisation of a Centrifugal Pump: The
Relationship to an Artificial Heart. in Australasian Association for Engineering
Education. 2002. Canberra, Australia.
Timms, D.L. and A.C.C. Tan. Hydraulic Force and Impeller Evaluation of a
Centrifugal Heart Pump. in International Symposium on Combustion Engine and
Marine Engineering (ISCEM 2003). 2003. Busan, Korea.
Tan, A.C.C. and D.L. Timms. Experimental Flow Visualisation of an Artificial
Heart Pump. in International Symposium on Combustion Engine and Marine
Engineering (ISCEM 2003). 2003. Busan, Korea.

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1.6.3 Published Abstracts
Timms, D. L. Complete Mock Circulation Loop For The Evaluation Of
Cardiovascular Devices in Heart Failure and Rotary Blood Pump Summit, 2004.
Cleveland, Ohio, USA.
Timms, D. L. LVAD Pump Performance and Force Characteristics in a Pulsatile
Mock Circulation Loop in Heart Failure and Rotary Blood Pump Summit, 2004.
Cleveland, Ohio, USA.
Timms, D.L., A.C.C. Tan, and M.J . Pearcy. Flow Visualisation of a Centrifugal
Blood Pump. in World Congress on Medical Physics and Biomedical Engineering
(WC2003). 2003. Sydney, Australia.
Timms, D.L., A.C.C. Tan, M.J . Pearcy, K. McNeil, and A. Galbraith. Force
Characteristics of Centrifugal Blood Pump Impellers. in World Congress on Medical
Physics and Biomedical Engineering (WC2003). 2003. Sydney, Australia.
Timms, D. L. and Tan, A. C. C. Performance Characteristics of a Centrifugal
LVAD in Annual Queensland Health and Medical Scientific Meeting, 2003.
Brisbane, Australia.

1.6.4 Patents
Provisional Patent Continuance Application Fluid Pump (AU2004/906579), 2004
International Patent Application Fluid Pump (PCT/WO2004098677); Inventor
Daniel Timms, Entering National Phase in International Countries, 2004
Chapter 2 Literature Review
2-1
Chapter 2
Literature Review
This section provides a focused literature review on many of the important aspects of
implantable ventricular assist device technology relevant to this thesis. Additional
reviewed material relating to the field of mechanical cardiac assistance is included in
Appendix A.
This first section highlights the increasing incidence of heart failure in the
developing world. Current treatment options are discussed, with particular emphasis
placed on the potential benefits of mechanical assistance.
The design requirements of such devices are then outlined, focusing on compatibility
and performance with respect to size, lifetime, blood damage and efficiency. The
notion of device control with respect to patient activity, and the incidence of
ventricular collapse, is then introduced.
A brief review of flow visualisation literature is provided prior to a summary of the
conducted background study in this field. The purpose was to identify regions of
turbulence and stagnation that may generate blood trauma in a centrifugal pump.
Right heart failure can sometimes accompany left heart failure, and the prevalence
and cause of this dysfunction is therefore detailed. This information lends support to
the need for bi-ventricular assistance, with the current device techniques used to
address this situation presented.
Current mechanical assist devices are then briefly reviewed, from the first generation
pulsatile devices, to the third generation rotary devices. Focus is drawn toward the
centrifugal type, with the methods of impeller suspension and rotation presented.
The magnetic bearing technique used for impeller suspension is expanded in the final
section. Current configurations employed by various centres are included, before a
brief summary of the findings from a background study is presented. The purpose of
this study was to identify the various magnetic bearing options available for
complete impeller suspension in each of the VAD designs described in this thesis.
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2.1 Heart Failure and Treatment Options
Incidence of Heart Failure
The incidence of Chronic or Congestive Heart failure (CHF) is increasing each year.
Three million US patients experienced CHF in 1995, with 400 000 new cases
diagnosed each year (McCarthy 1995; Nakazawa, Takami et al. 1997). By 2001,
these figures increased to 4.7 5 million and 550 000 respectively, while the
worldwide figure was estimated at 800 000 1 million new cases per annum (Data
1996; DeBakey 2000; American_Heart_Association 2001; Anderson 2001; Rose,
Gelijns et al. 2001). Heart Failure also affects infants, with 15,000 babies born each
year with congenital defects (Chen, Smith et al. 1998).
CHF remains a leading cause of morbidity and mortality in the United States,
forming the principle cause of death in approximately 55,000 to 60,000 patients
annually, and a contributing factor in another 200,000-250,000 (Schoeb, Barletta et
al. 2000). Fifty percent of patients diagnosed with CHF will die within one year, and
seventy percent by five years (DeBakey 2000).
The New York Heart Association classifies the Congestive Heart Failure patients
into Class 1 (35%), Class 2 (35%), Class 3 (25%) and Class 4 (5%). Only patients
listed as class 4 are eligible for cardiac transplant. As many as 4000-4500 American
patients from class 4 are listed for transplant each year (Anderson 2001). However,
due to the shortage of donor hearts (less than 3000 worldwide (Rose, Gelijns et al.
2001)), the transplantation rate according to the United Network for Organ Sharing
(UNOS) scientific registry was between 2100-2400 per year in the late 1990s
(McCarthy 1995; Data 2000; American_Heart_Association 2001), with 770 patients
succumbing to their illness while on the waiting list (Nakazawa, Takami et al. 1997).
In 1995, sixty-six percent of registrants had been waiting over 6 months on the
UNOS list and the average waiting time for a donor organ has now increased to over
300 days for outpatients, contributing to the 15 to 20 percent mortality of waiting
heart transplant candidates (Takami, Otsuka et al. 1998).
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In Australia, cardiovascular disease is the leading cause of death over any other
disease. Currently around 44 per cent (50,797) of all deaths each year are directly
related to heart disease. Of these, 2500 Australians died in 1998 as a direct result of
heart failure ((AIHW) 2001). During this year, 72 heart transplant operations were
performed, with this number ranging from 65-100 from 1994 to 1999. A total 1146
transplants have been performed in Australian and New Zealand from 1984-1999
with the waiting period for transplant between 1-1687 days (Waters 1998; Davies
and Senes 2003). Success rates are high for these patients, with upwards of 80% of
patients still alive after 5 years.
A number of sources have estimated the number of patients that would benefit from
heart transplantation surgery, or ultimately mechanical assistance. The American
Heart Association estimate that annually the lives of between 20,000 and 40,000
Americans would improve with heart transplantation, while Schoeb et al. (2000)
predict between 70 000 120 000 and Chen et al (1998) approximate 35,000 to
165,000. McCarthy (1995) and Guy (1998) predict that 35,000 - 70,000 US patients
with Class IV heart failure could benefit from mechanical support, while Anderson
(2001) estimates this number at 100,000 patients worldwide.
Alternative Treatment Options to Heart Transplant
Since a large percent of heart failure is attributed to left ventricle failure, an
implantable LVAD appears as a promising alternative to cardiac transplantation.
Other alternatives include Drugs, Xeno-transplantation (Lewis and Graham 1995),
Cardiomyoplasty (McCarthy 1995) and Stem Cells. However some of these
techniques are currently either ineffective for the entire patient population, or have
ethical issues. For example, although developing pharmacological therapies
improves survival, symptomatology, and quality of life for Class II and III heart
failure, some patients become tolerant or develop side effects that prevent drug use,
and therefore mortality remains high (Anderson 2001).
2-4
Mechanical Assistance
The shortage of donor hearts, and expense of heart transplantation, has accelerated
the development of mechanical cardiac assist devices. Therefore, the demand for
mechanical circulatory assistance is expected to increase significantly as the
incidence of heart failure increases.
Devices can be employed to bridge a patient to heart transplant, to recovery, or as
destination therapy. With the success of mechanical assistance, indications are
widening to include patients not considered transplant candidates.
Such a device will help to alleviate the demand on worldwide health care system by
offering an alternative to expensive drug therapy associated with organ transplant
and other conventional heart failure treatment. Furthermore, the additional capacity
is provided for terminal or waiting list patients to relocate from intensive care units
to cheaper wards, or ultimately leave the hospital and return home.
Bridge to Transplantation (BTT)
The survival rate of heart transplantation after the use of cardiac prothesis as bridge
to transplantation is in the range of 90 percent, similar to straight heart
transplantation. However before this stage, 30 40 percent of patients die during
prothesis support. Therefore, at least 50 percent of patients on cardiac prothesis
support survive after transplantation. Although this percentage is low, Nose et al
(2000) note that many of these patients would die without mechanical support.
Bridge to Recovery (BTR)
It has been reported that diseased hearts would recover if given rest for one year. By
supporting cardio myopathic patients mechanically, it is believed outcomes should
improve substantially, and by allowing the diseased heart to remain, the patient is not
totally device dependent (Nose, Yoshikawa et al. 2000). Some cardio myopathic
patients have been weaned after three weeks of support, while chronic unloading also
improves ventricular function (Takami, Otsuka et al. 1998).
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REMATCH Trial
The Randomized Evaluation of Mechanical Assistance for the Treatment of
Congestive Heart Failure (REMATCH) was a multi-centre study supported by the
American National Heart, Lung and Blood Institute. The 3 year (May 1998 J une
2001) randomized trial compared the long term implantation of the TCI Heartmate
VE LVAD (68 patients) with optimal medical management (61 patients) for patients
with end stage heart failure who require, but do not qualify to receive cardiac
transplant (Rose, Gelijns et al. 2001).
The primary objective was to determine the effect of the LVAD on mortality from all
causes, while secondary objectives were to analyse cardiovascular-related mortality
and cases of worsening heart failure, assess functional status and health related
quality of life and finally cost effectiveness.
Due to the risks and lifestyle implications of living with an LVAD, it was concluded
that optimal medical management would provide a more rigorous test for the device.
To qualify for the REMATCH trial, patients must have had class IV heart failure.
They were also ineligible for cardiac transplant for one or more of the following
reasons: Older than 65 years, Diabetes with end organ damage, Chronic renal
failure, Major physical or psychiatric co-morbidity (Cancer, Obesity etc)
25% of the optimal medical therapy group survived at one year versus 50% of the
LVAD group. The survival was 8% and 23% after two years respectively.
The cause of death in the control group was heart failure, whereas sepsis and device
failure accounted for the majority of deaths in the device group. Adverse events, such
as device malfunction, bleeding and infection occurred 2.35 times more often in the
device group. The probability of infection was 28% within 3 months of implantation,
with the device failing 35% of the time after 2 years.
Although the trial indicated an increase in quality of life for patients receiving LVAD
therapy, it is unclear if the magnitude will be sufficient to convince the medical
community that this expensive technology can be reasonably considered an
alternative to the biological replacement of a heart.
2-6
2.2 Ventricular Assist Device Design Considerations
There are many recommendations and requirements to consider when designing an
implantable VAD. For example, the device should be power efficient, avoiding
on/off systems. Atraumatic and anti-thrombogenic characteristics are essential, aided
by the elimination of valves. The device must be durable for long term support and
inexpensive. Additionally, the pump should output pulsatile flow in conjunction
with the failing heart, due to the flow characteristics of a rotary pump (Nose,
Yoshikawa et al. 2000). The service life for a VAD intended for alternative to
transplant use is 10-15 years. Power consumption should be less than 10W with a
maximum temperature of 42
O
C for device to tissue interface. Ample and
straightforward flow paths should be provided to minimise hmolysis and
thrombosis formation. Maher et al (2001) concede that the challenge of pumping
blood with undue damage has largely been solved, leaving power system and
management, speed control issues and patient interface issues.
Lifespan / Mechanical Failure
The operational lifetime of a VAD is dependant on the mechanical stability and
reliability of components. Components that move and contact each other are
subjected to stresses and strains that will result in their eventual failure.
Diaphragm type VADs are already routinely used as BTT devices, however the
large size and mechanical wear (due to valves) limits their operational life to 2-3
years in patients over 40kg (Schoeb, Barletta et al. 2000; Burke, Burke et al. 2001).
Achievement of a service life of 10-15 years may not be possible with mechanical,
blood immersed bearings, nor rotating mechanical seals. Therefore many groups
have investigated and are currently developing rotary blood pumps with levitated
rotors (Loree, Bourque et al. 2001).
Nose et al (1999) noted that recovery of dilating cardio myopathic hearts can occur
within 6 months 1 year. Therefore a reliable pump able to operate in excess of 2
years is desired; a characteristic not afforded by axial type pumps supported by
wearable bearing systems due to their relatively high rotational speed.
2-7
Thrombosis
Another concerning factor for implantable blood pump design is thrombosis. Clots
form in areas of stagnation and on foreign bodies or rough surfaces. The potential
for more damage can occur if this clot becomes dislodged (embolism), and carried
away to a smaller vessel, fatally cutting its blood supply (e.g. stroke).
Both Miyazoe et al. (1999) and Nishida et al. (1999) identify the gap beneath the
impeller as the most obvious area for low flow, as blood leaks back from the volute
to this region and has no mechanism to dissipate.
The ability to control the clotting of blood is a feature of human circulation. The
endothelial cells of arteries and veins secrete a variety of chemical substances that
inhibit blood clotting on their walls. Artificial materials used in implants do not have
this ability; therefore the blood may clot when presented with a foreign surface.
This may be overcome with specialized materials or by the use of drugs such as
heparin. Kopp et al. (2002) suggest that bonding heparin to biomaterial surfaces
decreases protein activation.
In the gyro series pump, a pivot bearing supports the impeller. This bearing is the
site for stagnant flow and is the most potential thrombogenic area inside the pump.
In vivo testing performed by Nakata et al. (2000) found firmly attached thrombi at
the top and bottom bearing areas. It is proposed that these thrombi do not dislodge
and form embolic events.
The Heartmate VAD series employ a textured surface to promote the growth of a
protein layer on the blood contacting surfaces (Maher, Butler et al. 2001). This
technique aims to reduce levels of thombosis formation and cell damage by
attempting to recreate the arterial lining.
Hmolysis
Hmolysis results from the shearing and rupturing of red blood cells and consequent
release of haemoglobin into the bloodstream. The degree of damage is proportional
to the magnitude of shear force and cell residence or exposure time (Paul, Apel et al.
2003). Many groups have attempted to correlate these factors with actual haemolysis
levels, with most agreeing that a threshold exists sparking significant damage, as
opposed to cumulative damage.
2-8
Threshold
Nevrail (1969) concluded a threshold value of shear stress exists at 1500 dyne/cm
2

(150 Pa) for the start of RBC lysis, while the majority of RBC hmolysis occurs at
shear stress values exceeding 3000 dyne/cm
2
(300 Pa). No appreciable damage is
detected when exposure levels were limited to 1000 dyne/cm
2
(100 Pa).
Paul et al. (2003) used a coette device to evaluate haemolysis within shear ranges
from 30 450 Pas, with residence times of 25 1250ms. The results indicate a
threshold exists for elevated haemolysis above 425 Pas and 620ms.
Allaire et al. (1999) indicate shear stress levels in all areas of the pump should be
kept below 500-1800 Pa at all times.
Index of Haemolysis
Hmolysis is measured with a normalised index (Equation [ 2-1 ]) and standard
procedure outlined in (ASTM_F1841-97 1998).
T Q
100

100
Ht - 100
V Hb free NIH
=

[ 2-1 ]
Where NIH
freeHb
V
Ht
Q
T
Normalised Index of Haemolysis (g/dL)
Increase in Plasma Free Haemoglobin (g/L)
Circuit Volume (L)
Percent Hematocrit (%)
Flow Rate (L/min)
Sampling Time (min)

Lewis and Graham (1995) identified that hmolysis levels are only considered
clinically significant if plasma free haemoglobin values average more than 0.01
g/100L. Values of NIH for different centrifugal type blood pumps are given in Table
2-1.
Table 2-1 - The index of hmolysis of blood pumps
Continuous Flow Pumps Index of Hmolysis (g/100L)
BP-80
Nikisso
Kyoto MSCP
CFVAD#2
CFVAD#3
Baylor C1E3
Baylor PI601
Baylor PI701
Baylor KP101
Ventrassist

0.0017
0.00066
0.015
0.0086
0.0124
0.0007
0.0028
0.004
0.01
0.005

2-9
Clearance Gaps
Nishida et al. (1999) propose the design factors greatly affecting the level of
hmolysis are the radial and axial clearance gaps between the rotating impeller and
stationary pump casing. These gaps typically range from 0.2mm - 3mm, and should
be optimised to produce the lowest levels of hmolysis whilst maintaining the
highest possible hydraulic efficiency. The rotational speed of the impeller directly
affects the level of shear stress encountered in the clearance gaps. A larger peripheral
velocity results in larger shear stresses, therefore the rotational speed of the impeller
should be minimised.
In a study on the Ventrassist device conducted by J ames et al. (2003), axial clearance
was found not to influence the level of haemolysis. The clearance gaps were small
(0.07 0.3mm), and although CFD analysis predicted an increase in regional shear
stress, blood cell exclusion and a smaller residence time in these gaps accounted for
the maintenance of low haemolysis levels. Despite previous claims that impeller
surface roughness has no effect on haemolysis, the group produced results indicating
a reduction in NIH for hand polished (0.1-0.2 um) surfaces compared to machine
finished (0.2-0.7um).
Many authors present results of increased haemolysis with decreasing radial
clearance below 0.5mm. However, it is suggested that further reductions in clearance
gaps below 0.1mm may actually improve haemolysis results. The majority of red
blood cells are thought to avoid entering the gap, and when combined with a smaller
fluidic volume and shorter residence time, fewer cells are damaged (J ames,
Wilkinson et al. 2003).
Turbulence
Another aim for hmolysis reduction is smooth flow. Turbulent flow increases
stresses on the blood and although they may not exceed the rupture stress for RBCs,
undetectable trauma can occur leading to a decrease in the haemolytic threshold of
the whole blood (Allaire, Wood et al. 1999). This is likely to occur at the outlet
region, by blood colliding with casing wall (Nishida, Asztalos et al. 1999).
2-10
Heat Generation
Another form of blood damage involves exposure to excessive heat levels, which
cause proteins in the blood to denature. Proteins are sensitive to their environmental
conditions, and therefore irreversible damage occurs if blood is exposed to heat
levels higher than 44
o
C (Tortora 1987). Heat may be generated at points of contact
between moving components as well as electrical power sources.
Yamazaki et al. (1998) used a purge fluid system to keep the shaft seal below 40
degrees in a device operating at 2500rpm and producing 7 L/min at 100mmHg
consuming 9 Watts of power.
Tasai et al. (1994) conducted heat generation tests on a polycarbonate motor housing,
which demonstrated excessive temperature rise. The material was replaced with
anodised aluminium, which exhibits excellent heat conductivity. An effective
thermal path was established to distribute the motor heat flux to the circulating
blood. At worst case, the heat flux from the device was calculated at an acceptable
level to surrounding tissue, i.e. less than 0.062 W/cm
2

Song et al. (2004) included a thermal analysis in a CFD model of the CFVAD4. The
study concluded that the temperature rise due to magnetoelectric heat generation and
thermal dissipation in surrounding tissue and blood was insignificant.
Takatami et al. (1998) evaluated heat generation in the miniaturised Gyro PI pump.
The study revealed the temperature inside the actuator rose to 43.5 deg when
operating at 6.16 Watts.
Wakisaka et al. (1998) presumed that heat absorption of the surrounding tissue was
about 0.01-0.02 W/cm
2
. They observed thermal adaptive responses of the lung and
muscle tissue under a heat load of 0.02-0.06 W/cm
2
. In these cases, the capillaries in
the surrounding smooth fibrous tissue might play an important role in cooling down
the pump. Particularly in smaller devices, since the heat absorption capacity of the
surrounding tissue is decreased by reducing the pump surface area.
Size / Anatomical Compatibility
Current commercially available VADs are large and heavy, limiting their application
to large adults. The desirable outcome from a new VAD design would be the ability
to implant in patients of all size. Rotary type VADs have the potential to achieve
2-11
this goal, since the geometry is intrinsically smaller than their pulsatile counterparts.
Device size is a concern for successful implantation. It must not only conform to the
available space in the patients abdomen, but a reduced size is essential to
accommodate small children and women.
Physiological Control
Physiological control of ventricular assist devices is an important feature to provide
sufficient perfusion to patients with changing levels of physical activity.
Wu et al. (2004) proposed a control algorithm that uses the change in pressure across
the device and motor signals as feedback signals, obtained from long-term reliable
sensors. A safe range is set for the end diastolic ventricular pressure (-3 to 15mmHg)
to prevent ventricular suction as well as pulmonary congestion. The ultimate goal of
the controller was to return perfusion, mean arterial pressure and end diastolic
pressure to within the normal range. Maintenance of these values while transitioning
from conditions of rest, sleep and exercise for variable levels of ventricular function
was demonstrated within a few heartbeats.
Ventricular Collapse
Olegario et al. (2003) performed a study aimed at controlling the outflow of two
centrifugal pumps acting as a total artificial heart. Sudden and large changes in
outflow from rotary pumps produce negative inflow pressures which can increase the
incidence of atrial or ventricular wall suction, particularly in the left heart. This
predicament can be alleviated by reducing the pump speed which reduces outflow.
This technique is effective for LVAD situations, as the failing natural ventricles
remain and can assist limited flow. However, rotary pump TAH devices rely solely
on the device to produce flow, and thus any reduction is pump speed is met with
critically low perfusion. Since the left pump operation is based on the total peripheral
resistance (1/R control), the proposed solution for the latter case involves the control
of right pump outflow to maintain sufficient left atrial blood volume. That is, left
atrial pressure is monitored, and any reduction is compensated by an increase in right
pump outflow. However, the delay between the right pump and left atrium may result
in an excessive increase in right outflow causing right atrial suction. Therefore the
pulmonary circuit dynamics must be integrated into the control algorithm.
2-12
2.3 Flow Visualisation
Flow visualisation is an important technique used to highlight areas where
modifications may improve the fluid flow pattern. A specialised application of flow
visualisation is in the area of blood pump design (Ikeda, Yamane et al. 1996; Allaire,
Wood et al. 1999).
Consideration must be given to the traumatic effect of the pump on blood. The
incidence of haemolysis and thrombosis are most damaging to red blood cells. The
former results from shearing and rupturing of red blood cells (RBC) and release of
haemoglobin into the bloodstream (Yamane, Clarke et al. 1999), while the latter
results from the formation of blood clots in regions of stagnant or low flow (Allaire,
Wood et al. 1999). By employing flow visualisation techniques, it is possible to
identify areas of high shear, turbulence and low flow or stagnation. These studies are
often conducted in conjunction with computational fluid dynamics (CFD) to refine
the model. Results can be categorised as either qualitative or quantitative.
Qualitative
A qualitative study can instantly identify regions of low flow or stagnation as well as
turbulent regions by analysing captured images using high speed videography
(Nishida, Asztalos et al. 1999). Another technique uses a film of high viscosity oil
painted on the surfaces of interest (Ichikawa, Nonaka et al. 2002). This provides
information on flow patterns at the fluid contacting surfaces only. Qualitative
information is useful for identifying the regions of the pump susceptible to
thrombosis formation and blood cell destruction respectively. Investigators may then
target these regions for further quantitative analysis.
Quantitative
Quantitative analyses commonly use particle image velocimetry (PIV) techniques to
identify particle velocities (Tsukiya, Taenaka et al. 2002). This data can be used to
reproduce the boundary layers within the pump, providing an opportunity to
calculate shear stress levels. The oil film technique can translate quantitative values
of shear stress by incorporating the oil viscosity; however the margin of error is
relatively large. Quantitative information can be related directly to thresholds of
shear stress estimated to cause haemolysis (Nevrail 1969; Allaire, Wood et al. 1999).
2-13
Flow Visualisation Study
A flow visualisation investigation (Timms, Tan et al. 2003; Tan, Timms et al. 2004)
was undertaken as background research on a scaled up centrifugal pump. The pump
geometry did not reflect the final VAD designs; however important qualitative
observations relevant to all centrifugal blood pump designs were made, which
influenced these final VAD designs.
The study was conducted in three stages using the particle seeding and high speed
videography method;
1. Preparation of a rig for testing to be conducted,
2. Utilisation of adequate equipment and implementation of an experimental
technique to produce results, and
3. Qualitative analysis of captured data to identify target regions for further
detailed quantitative analysis.
Images were captured from identified regions of interest at design and below design
flow rates. It is envisaged that the final implanted VAD will not always operate at
design conditions as the level of assistance required is dependant on the individual
patients level of heart failure. Therefore, turbulence and stagnation at off design
conditions should not be overlooked.
The flow visualization technique described provided valuable insight into the internal
flow patterns within the centrifugal blood pump design, identifying the region
beneath the impeller as a stagnation zone together with the outflow and clearance
regions as potential sites for haemolysis.
Stagnation beneath the impeller prompted investigations into the elimination or
improvement of washout flow in this region. Techniques such as washout holes
would improve flow, while implementing a double sided impeller would eliminate
the problem completely.
Recirculation was found at the cutwater section. This was further emphasized when
the pump was operated at capacities below the design value, as encountered in the
practical application of the implanted VAD.

2-14
2.4 Right Heart Failure and Bi-Ventricular Support
The main goal of mechanical support is to increase the blood flow to end organs.
Since the left and right hearts are in series, an increase in flow to the systematic
circulation, as observed in LVAD support, will result in an increase in venous return
to the right heart. Therefore the cardiac output of the right heart must increase.
Clinically, if the left heart output is doubled with the institution of a LVAD, the
output of the right ventricle must match (Goldstein and Oz 2000).
Causes of Right Heart Failure
Goldstein and Oz (2000) explain that the introduction of LVAD support may unmask
pre-existing right ventricular dysfunction, by attempting to increase the venous return
beyond the capacity of the right ventricle. This right ventricular dysfunction may
only become apparent after the left ventricle is assisted. To obviate the need for Bi-
or R-VAD assistance, patients receive treatments that attempt to offset existing or
developing pathological conditions.
Goldstein and Oz (2000) continue that with LVAD support, unloading of left
ventricle reduces its volume and pressure. This may result in the interventricular
septum bulging to the left during right ventricle systole, thus reducing the efficiency
of the right ventricle contraction. However, many studies of normal hearts conceded
a change in right ventricle geometry did not affect overall performance. Therefore, it
is apparent that anatomic ventricular interactions are not responsible for the profound
right ventricle failure encountered in patients receiving LVAD support, compared
with the effects of pre-existing pathological conditions. For example, the detrimental
effects of ventricle interaction were negligible compared to the effects of ischemia.
An LVAD was unable to improve the impaired right ventricle cardiac output, due to
the inability for the right ventricle to pump sufficiently through the pulmonary
vasculature. The cardiac output was found to improve with the introduction of right
ventricle assistance or Bi-VAD.
Lewis and Graham (1995) supported these factors, citing altered ventricular
interdependence, increased pulmonary vascular resistance and changes in right
ventricle loading as predominant causes for the onset of right heart failure.
2-15
Need for Bi-Ventricular Support
Nose et al. (1999), Yoshikawa et al. (2000) and Lewis and Graham (1995) each note
that approximately 25-40% of patients receiving LVAD support develop right heart
failure syndrome, which can lead to sepsis and/or multi-organ failure. They explain
that multi-organ failure is induced by poor liver portal circulation as a result of high
venous pressures above 20mmHg. This leads to 30 percent of VAD patients
succumbing to this cause of death (Nose, Yoshikawa et al. 2000).
Kavarana et al. (2002) concede that the introduction of inhaled nitric oxide and
phosphodiesterase inhibitors has reduced the use of right ventricular assist devices,
however right ventricular dysfunction is still a serious problem in patients receiving
left ventricular assist devices.
Yoshikawa et al. (2000) suggest that 50 - 60 percent of the LVAD population require
Bi-ventricular assistance. Goldstein and Oz (2000) identified that this support is
dependant on the patient population, with usage varying from 10% to 85% of support
cases. Suffice to say, a large number of the patient population can be salvaged from
multi-organ failure by introducing biventricular support as this reduces the higher
venous pressure (Nose, Yoshikawa et al. 2000).
Farrar et al. (1997) also recognised the need for the introduction of an RVAD, since
in this study, 48% of the patients received Bi-VAD support as a bridge to cardiac
transplantation.
Hence, there is an increasing need for the development of a Bi-Ventricular assist
device and thus current research is focussed on this goal.

2-16
Current Bi-VADs and Techniques
Nose et al. (1999) and Nose et al. (2000) outline the current bi-ventricular assistance
technique of implanting two devices (LVAD and RVAD). However the large size of
these devices, particularly the pulsatile types, poses a problem for anatomical
compatibility. Thus they suggest the non-pulsatile rotary blood pump is the only
option.
Current development of a pulsatile type combined Bi-VAD for a total artificial heart
(TAH) centre around extracorporeal and paracorporeal systems, such as the moving
actuator mechanism proposed by Park et al. (2003). However, this device is
relatively large and has a moving actuator which is prone to wear.
To produce the function of a total biventricular assistance with continuous flow
pumps, Nose et al. (1999) implanted two identical VADs in the abdominal wall for
left and a right ventricular bypass. Each pump had its own independent control and
actuation system. The study lasted for 72 days and was terminated due to functional
inflow obstruction.
Yoshikawa et al. (2000) then developed a small yet efficient RVAD that could be
used in conjunction with a conventional LVAD to provide Bi-VAD support. The
LVAD operated under performance characteristics demanded by the systemic
circulatory system, whilst the RVAD met the pulmonary circulatory system
requirements.
To this date, Bi-VAD technology is either too large or necessitates having to implant
two independently working pumps. The development of a compact single continuous
flow Bi-VAD would increase the application of this form of assistance to encompass
the smaller body surface area patient population.

2-17
2.5 Current Mechanical Assist Devices
History has witnessed the development of many types of artificial cardiac device.
Guy (1998) reported on the development of pneumatically driven blood sacs, roller
pumps, pusher plate and diaphragm pumps. Maslen et al. (1998) identified these
types as inherently flawed with reliability problems, which led to the development of
devices based on a rotating impeller.
The most common use of continuous flow centrifugal blood pumps is in short term
surgical procedures involving cardio-pulmonary bypass (CPB). Despite this success,
Miller et al. (1990) and Allaire, et al. (1996) suggest that a variety of complications
served to delay their application as viable risk free long-term total cardiac
replacement devices, and as such were viewed only as bridge to transplant devices.
However, Maslen et al. (1998) predicted that with improved design and testing, these
devices could function as a permanent replacement for heart failure.
Types of Mechanical Assist Devices
The classification of mechanical assist devices relates to their characteristic outflow,
followed by their generation or bearing configuration).
Pulsatile
Franzier et al. (1992) reported that although pulsatile type pumps are similar in
operation to the human heart, they are relatively large and require valves which can
cause blood cell trauma.
First Generation
The first generation of pumps incorporate sacs, diaphragms or pusher plates to
produce pulsatile outflow from the device. They are relatively large and are powered
either pneumatically or electrically; with a maximum expected lifetime of two or
three years.
Non-Pulsatile / Continuous Flow
The continuous flow devices generally incorporate an axial or centrifugal type rotary
impeller. Kawahito et al. (1996) outlined that although axial flow pumps are
relatively simple in their design and construction, they require high rotating speeds
and are usually supported by contact pivot bearings. Sasaki et al. (1992) and Ohara et
al. (1994) describe that centrifugal flow pumps have high efficiency, but initial
2-18
designs required frequent replacement due to moving component wear and heat
generation around the impeller shaft, seals and bearings. This imposed a significant
limitation if they were to be used for long-term assistance. Several techniques have
been proposed to solve this problem, ranging from complete magnetic-suspension
(Akamatsu, Nakazeki et al. 1992), two-pivot bearing support (Ohara, Makinouchi et
al. 1994), free impeller suspension (Ohara and Nose 1994), and finally completely
passive hydrodynamically suspension (Watterson, Woodard et al. 2000).
Second Generation
Second generation pumps are classified as continuous flow axial or centrifugal
pumps with impellers supported by blood immersed or pivot bearings, and are rated
to five year durability. The majority of axial flow blood pumps are classified in this
category.
Third Generation
Magnetically levitated and hydrodynamic non-contact impeller suspension
characterise the third and latest generation of blood pumps. A ten year lifetime is
expected due to the elimination of component wear from mechanical contact
(Takatani 2001).
Table 2-2 categorises some of the current mechanical assist designs.
Table 2-2 Current Mechanical Assist Devices
TAH Abiocor (Stevenson and Kormos 2000)
Cardiowest - Jarvik 7 (Arabia, Copeland et al. 1999; Copeland, Smith et al. 2001)
Penn State / 3M (Stevenson and Kormos 2000)
Pulsatile
LVAD
Novacor (Stevenson and Kormos 2000; Copeland, Smith et al. 2001)TCI Heartmate I
(McCarthy 1995; McCarthy, Schmitt et al. 1996)Thoratec IVAD
Arrow Lionheart
Axial Flow
LVAD
Heartmate II (Burke, Burke et al. 2001; Maher, Butler et al. 2001)
J arvik 2000 (J arvik 1995)Debakey/Micromed (Tayama, Olsen et al. 1999; Stevenson
and Kormos 2000)
Centrifugal
LVAD
Heartmate III (Loree, Bourque et al. 2001; Maher, Butler et al.
2001)Heartquest(CFVAD) (Khanwilkar, Olsen et al. 1996; Bearnson, Olsen et al.
1998)Ventrassist (Watterson, Woodard et al. 2000)Ibaraki (Masuzawa, Kita et al.
2000; Masuzawa, Kita et al. 2001)Baylor GYRO series (Yoshikawa, Nakata et al.
1999; Yoshikawa, Nonaka et al. 2000)

2-19
Axial VAD
Song et al. (2003) provided a comprehensive review of all axial flow devices. Most
devices, such as the HEARTMATE II, J AVIK 2000 and Micromed DeBakey, are
generally limited to second generation pumps; however, the INCOR device
incorporates third generation magnetic technology. Axial type devices are
characteristically small, and consequently incorporate rotary blades that spin at
10,000 to 20,000 rpm, which may lead to excessive shear stress. Additionally, these
pumps require stationary diffuser guide vanes, providing a site prone to thrombus
formation. Apart form the INCOR device, the service life of axial flow pumps is
predicted at below five years, due to the contact pivot bearing support mechanism.
Centrifugal VAD
Continuous centrifugal flow devices address many of the inherent problems
associated with first generation positive displacement mechanical assist devices.
Advantages
The characteristic advantages over first generation devices include a lack of valves,
no compliance volume, anti-thrombogenecity due to a smaller blood contact area,
mechanical simplicity, smaller size, higher efficiency, lower costs, fewer moving
elements, and lower hmolysis (Park, Nishimura et al. 1996; Nishida, Uesugi et al.
1997; Tsukiya, Akamatsu et al. 1997; Takami, Otsuka et al. 1998; Takatani 2001).
Miller et al. (1990)

declare the superiority of centrifugal pumps due to the ability to
generate large flow rates and pressure heads, and the ability to easily power and
control such systems electrically. In addition, large ventricular volumes, valves or
diaphragms are non-existent, ensuing increased durability with less moving parts.
Yamazaki et al. (1997) support the use on the basis that rotational speeds are lower
than axial pumps, which would result in longer bearing life. The elimination of
stationary blades also reduces the risk of thrombosis formation.
Akamatsu et al. (1992) and Curtis et al. (1999) indicate the advantages of operational
simplicity, compactness, and low cost compared with other mechanical assist
devices.
Finally, Smith et al. (1999) point out the ability to change flow and head output by
simply changing the RPM of the impeller is beneficial in accommodating body
physiological changes.
2-20
Disadvantages
Akamatsu et al. (1992) were aware of centrifugal pump limitations, stating that high
friction in the bearing and seal generates a large amount of heat. Yamazaki et al.
(1997) warned that if this heat becomes too high, the proteins within the blood will
denature resulting in irreversible blood damage.
Wampler et al. (1999) described how the process of sealing the blood at the
driveshaft severely limited the durability of initial rotary blood pumps while Aztalos
et al. (1996) expressed the concern that excessive rotational speeds lead to large
shear stresses in the radial clearance.
Finally, Goldstein and Oz (2000) outlined the possibility for regurgitant flows should
the pump stop. Since no valves are employed, blood flow back into the heart could
possibly worsen the patients heart failure. Vandenberghe et al. (2002) assessed the
effect of rotary blood pump failure on the hemodynamic condition using a
mathematical cardiovascular model. The simulated results indicated an increase in
aortic flow to compensate for the regurgitant flow through the device. This was
achieved by an increase in stroke volume and contractility to maintain perfusion and
arterial pressure. The study concluded that the acute hemodynamic state was not
lethal, and indeed reversible should support resume within a 15 minute timeframe.
Methods of Impeller Support and Rotation
Allaire et al. (1996) acknowledged that the simplest way to suspend a rotating pump
impeller is via a shaft, bearing and seal system. Unfortunately, they point out that this
arrangement introduces unreliability, as seals are subject to abrasive failure and
provide a site for heat generation, blood stagnation and clotting. Yamane et al.
(1995) thus predicted the operational lifetime of this pump is limited to a few days.
Wampler et al. (1999) proposed that until a viable alternative to the shaft seal is
implemented, the evaluation of this type of pump for use as a LVAD is restricted.
A number of authors have proposed various methods of suspending the centrifugal
blood pump impeller. Sipin et al. (1997) used a purged ball bearing system, Maslen
et al. (1996) developed a bearing/seal system, Watterson et al. (2000) utilized
hydrodynamic bearing forces and Yamane et al. (1997) implemented a monopivot
bearing. However, applying a magnetic motor-bearing system, potentially
minimizes all problems associated with the aforementioned forms of suspension
(Masuzawa, Ezoe et al. 2003).
2-21
Pivot / Blood Immersed Bearings
Blood immersed bearings form another means of impeller support. This type of
bearing may be surface lubricated with blood, and allow rubbing contact of ball
bearings. Thompson et al. (2003) proposed a system that incorporated wear proof
UHMWPE roller bearings with a service life in excess of ten years. Thrombosis
complications are avoided by purging the bearing system with saline at a rate of
30mL/hour.
Hydrodynamic Bearings
Alternatively, a thin fluid film between rotor and housing can be employed to
provide true hydrodynamic support with no rubbing contact (Wampler, Lancisi et al.
1999; Tansley, Cook et al. 2000; Tansley, Vidakovic et al. 2000; Watterson,
Woodard et al. 2000). However, Allaire et al. (1996) and Maslen et al. (1998) warn
that the bearing clearances may cause shear damage to red blood cells and lead to
hmolysis.
Magnetic Bearings
Maslen et al. (1998) detail a promising method of impeller suspension employing
magnetic fields to levitate the impeller. Magnetic bearings boast non-contact
suspension with large clearance gaps, thus eliminating any point-to-point contact to
reduce shear stress. These systems are described in further detail in the next section.
2-22
2.6 Design, Performance and Force Characteristics
Introduction
A review of literature relating to centrifugal blood pump design, performance and
hydraulic force characteristics is provided to outline current research and identify
areas for further investigation.
The literature review targeting the design of centrifugal blood pump impellers
provides a summary of the design parameters suggested and selected by various
research groups. Little information is provided on the design of volute casings,
diffusers and inlet configurations with respect to performance, although one recent
study used CFD techniques for assessment of these configurations (Song, Wood et
al. 2004). Few studies have focussed on the effect of volute clearance gaps on blood
damage.
The difficulty in predicting the performance characteristics of a centrifugal blood
pump due to their inherent dissimilarities to industrial applications was outlined in
the next section of this review. A set of dimensionless pump curves was sourced as a
means to compare new pump prototypes. Finally, conflicting reports were identified
regarding the effect of axial clearance gap above open impeller blades on pump
performance.
Relatively few studies feature in the final review of this section on centrifugal blood
pump hydraulic forces, revealing an important area for further investigation.
Knowledge of these forces is particularly important when designing a magnetic
bearing to completely suspend the impeller. To add to the review, a number of
hydraulic force studies conducted on industrial pumps were included. Both
experimental techniques and results are provided to help select the most appropriate
method of force evaluation, as well as provide a comparison to the data presented
later.
2-23
Centrifugal Blood Pump Impeller Design
Roto dynamic Impeller Design
Qian et al. (2002) identified four important factors for impeller design in centrifugal
LVADs; Dimension (Pump Type and Size), Vane Form (Profile) including exit
angle and vane number. Curtas et al. (2002) also identify vane number and profile as
critical, but also suggest that the shroud configuration and vane exit width are
important parameters for performance.
Dimension / Pump Type
The pumps dimension dictates the choice of pump type, and is selected according to
pump speed, pressure and flow rate (specific speed) at the design point. Pump type
selection based on specific speed calculations reveals the notion that centrifugal
pumps are more suitable than axial flow pumps for the rotary blood pump
application. Comparing the normalised head and flow curves for both centrifugal and
axial flow pumps of similar size shows the necessity for the axial flow pump
impeller to rotate at 140% greater tip speed than that of a centrifugal design. For
example, the practical range for impeller tip speed of an axial and centrifugal pump
for the LVAD application is between 10-15m/s and 4-7m/s respectively (Yamane,
Ikeda et al. 1996). Haemolysis levels are mostly affected by the creation of shear
stresses at the impeller tip, which are affected by the impeller rotational speed, but
more closely related to the impeller tip speed. This implies that a centrifugal pump
would produce a lower level of haemolysis.
Tansley et al. (2000) used the pump design techniques of Stepanoff (Stepanoff 1957)
to dimension/size their centrifugal pump for the LVAD application. This analysis
concluded the pump would operate at a specific speed (N
s
) of 1000, leading to an
impeller diameter of 40mm rotated at 2500rpm. An impeller tip speed of 4.9 m/s was
calculated after a speed constant of 0.95 was assumed.
Vane Profile, Exit Angle
Curtas et al. (2002) suggest that an optimum vane discharge angle exists for each
centrifugal pump application. Additionally, designs should consider the effects of the
inlet blade angle. Occasionally, inlet blade angle equals outlet blade angle, for which
case the profile should follow that of a logarithmic spiral. However, it may be
desirable to vary the blade angle as a function of radius. CFD focussing on
variations on blade profile between common entrance and discharge angles revealed
2-24
little effect of alternate profiles (logarithmic or otherwise) on performance.
Qian et al. (2002) make stronger claims that vane profile should take the form of a
logarithmic spiral, with a discharge angle (
2
) of 30. Their conclusion is founded on
the prediction that the fluid will follow streamlines based on mass, motion and
energy conservation. With an impeller following these principles, no turbulence
would be apparent in the vane channels and blood damage would be minimal. These
assertions were confirmed with favourable performance and haemolysis test results.
A study performed by Takano et al. (2000) analysed the effect of vane angle on the
performance of a centrifugal blood pump. The experimental results of a 35mm
diameter impeller showed that the radial vanes (
2
=83) produced the desired
pumping characteristics at a lower rotational speed (2900 rpm) to that required by an
impeller incorporating slightly backward facing (
2
= 73) vanes (3280 rpm).
However, hydraulic efficiency was not compared in this study.
These assertions are confirmed by CFD results presented by Curtas et al. (2002), who
concluded that the most head was produced from straight radial blades as opposed to
backwardly curved vanes. Efficiency was considered in this study and found that
although a greater head was produced, it was at the expense of efficiency.
Yamane et al. (1996) supported these claims with an indication that the slope of the
head-flow curve is determined by the discharge angle (
2
).
However, Smith et al. (1999) indicate that caution must be given to designs
incorporating high impeller inherent pressure/flow curves (produced from high vane
discharge angles) as they are characterised by low efficiencies which may impact on
battery size/life and the degree of heat generation. They therefore recommend that
the design of an impeller to achieve a desirable pressure/flow relationship an
efficient manner is a valuable exercise.
Finally, Masuzawa et al. (1999) conducted a flow visualisation study on the effect of
backward, radial and forward facing blades for the blood pump application.
Exit Width
Curtas et al. (2002) employed CFD techniques to determine the effect of exit blade
height (with a common axial clearance) on performance. The explanation centred on
the fact that a larger exit width (3mm) led to a reduced meridional velocity (c
m2
) and
2-25
thus an increase in head for a given rotational speed when compared to a smaller exit
width (1mm). The implementation of a larger blade width departed from
conventional design guidelines which called for a smaller width to maintain an exit
to inlet area ratio (a
2
/a
1
) closer to unity. They suggest the deviation in results from
conventional guidelines is acceptable since the effect of this area ratio on small
pumps is not well documented, and many other design parameters fall outside the
normal regions.
As mentioned, the exit width affects the magnitude of meridional velocity. This
directly impacts on the ratio () of absolute tangential velocity (c
u2
) to this
meridional velocity (c
m2
), which is maintained between 2 and 7 in industrial pumps.
Therefore, a disproportionately large exit width may lead to an excessively small
meridional velocity, which in turn increases the value of above 7, and as high as
28 (Tansley, Vidakovic et al. 2000).
Vane Number
The number of vanes contained on an impeller affects the level of slip, or blade
recirculation. For example, a large blade number reduces slip as there is less space in
the vane channel to allow recirculation. However, other fluid effective losses are
dominant in small pumps with low flow and speed. Therefore viscous effects
dominate the core flow within impeller passages, while velocities are generally not
sufficient to produce separation from the blades (Curtas, Wood et al. 2002).
Li (2000) conducted Laser Doppler Velocimeter experiments that confirmed the
effect of fluid viscosity on pump performance. As expected, higher viscosity fluids
result in a rapid increase in disc friction losses over the impeller shroud and hub, as
well as hydraulic losses in the flow channels. This suggests that a larger blade
number might result in a drop in efficiency, due to viscous drag on the larger surface
area. Furthermore, if slip is less of a concern, larger blade discharge angles may be
permissible to produce more head without the anticipated losses.
In the study performed by Qian et al. (2002), vane number and angle was selected as
a result of haemolysis testing performed on impeller configurations incorporating 5-7
vanes at discharge angles between 20-40. The results revealed six vanes at a
discharge angle of 30 are kindest with regards to haemolysis.
2-26
Shroud Configuration
Many of the current rotary blood pump impellers incorporate an impeller hub and
front shroud to improve hydraulic efficiency (Anderson, Wood et al. 2000; Chua,
Ong et al. 2003; Masuzawa, Ezoe et al. 2003). However, concerns are raised with
regard to the level of haemolysis or potential for thrombus formation within the
clearance gaps, particularly beneath the hub.
Chua et al. (2003) investigated velocity profiles within the axial clearance gap of the
shrouded type impeller of the magnetically suspended centrifugal blood pump
(MSCBP), while Anderson et al. (2000) used CFD techniques to investigate the
recirculation from impeller outlet to inlet within the axial clearance gaps. This
information is useful in predicting pump efficiency and effect on haemolysis or
thrombosis.
The effect of semi-open and open type impellers on hydraulic performance was
investigated by Tsukiya et al. (2002), revealing a slight drop in efficiency with the
former type. This result was due to an increase in recirculation flow beneath the
shroud to the impeller inlet via the included washout holes, caused by a larger
pressure gradient along the flow path.
Roto dynamic Inlet and Outlet Design
Few published studies have targeted the impact of inlet and outlet configurations on
centrifugal type rotary blood pump designs. However, Song et al. (2004) conducted
a CFD study to evaluate these inlet and outlet devices.
Inlet devices (Straight inlet, Inlet Volute, Inlet/Flat Elbow) shown in Figure 2-1
were compared with regard to anatomical compatibility, performance and predicted
impact on haemolysis. The straight area-converging inlet, although best from a
turbo-machinery standpoint, would require an effective pipe length of 250 mm to
provide straight, uniform and unsteady flow into the impeller eye. Obviously, this is
not practical in terms of implantable rotary blood pumps. The inlet volute is adopted
in most industrial single stage pumps. Although boasting improved anatomical
compatibility for implantable blood pumps, the main drawback (inlet swirling)
creates a challenge in impeller design to prevent this affecting overall pump
performance. Additionally, high shear stresses were found to occur in this
configuration, indicating the potential for elevated levels of haemolysis. Results from
2-27
the CFD analysis revealed the pump should incorporate a conventional inlet elbow,
which is hydraulically equivalent to a straight inlet for the low specific speeds
associated with rotary blood pumps. Further investigations revealed advantages of a
flat type inlet elbow incorporating a streamlined baffle on the further side, since
circumferential velocity is minimised and swirls are almost completely removed.
Figure 2-1 Inlet (Left) and Outlet (Right) Devices
(Song, Wood et al. 2004)

The relevant outlet devices discussed by Song et al. (2004) and displayed in Figure
2-1, centre on the use of a single type volute and outlet diffuser. The cross sectional
area of this volute increases from cutwater to outlet at an angle corresponding to the
direction of the absolute velocity vector at impeller discharge. The exit volute design
is suggested to initiate with the calculation of a throat area by assuming a value of
throat velocity obtained from theoretical references. Reference was made to the
importance of cutwater diameter selection to improve performance and reduce
recirculation between the cutwater and impeller. The final step involved drawing the
expanding base circle from cutwater to throat before implementing a 6-10 degree
divergence of the outlet diffuser. Figure 2-2 describes the double volute
configuration implemented by Chua et al. (2003) in the magnetically suspended
centrifugal blood pump (MSCBP).
This figure is not available online.
Please consult the hardcopy thesis
available from the QUT Library
2-28

Figure 2-2 Double Volute Configuration
(Chua, Ong et al. 2003)

Rotary Blood Pump Performance
Smith et al. (2004) noted the difficulty in predicting the performance of rotary blood
pumps from previous industrial pump data. Conventional pump designers benefit
from the collection of correlated empirical data combined with extensive practical
experience. Unfortunately this practice is not apparent in rotary blood pump design
due to the infantile stage of the field coupled with inherent dissimilarities from
industrial applications.
Smith investigated and compared numerous published pump performance results,
producing a family of rotary pumps developed for cardiac assistance (Figure 2-3).
2-29

Figure 2-3 - Non-Dimensional Performance of Rotary Blood Pumps
This graph shows the dimensionless performance curves for a number of axial, mixed flow
and centrifugal blood pump designs, which can be used to compare new prototype designs
(Smith, Allaire et al. 2004)

Three non-dimensional grouping ratios (flow, head and power coefficient) were used
to compare different designs (Table 2-3). This data provides the ability to compare
new designs to a family of rotary blood pumps. For example, a shut-off head
coefficient of 0.5 - 0.6 was suggested acceptable for the blood pump application.
Table 2-3 Dimensionless Coefficients
(Smith, Allaire et al. 2004)

This table is not available online.
2-30
The transition of Reynolds number from laminar to turbulent regime was noted at the
conventional 5.0 E
5
instead of 2.3 E
2
as suggested in cases of tube flow. Blood
pumps in general were found to exhibit a low Reynolds number (approx 7.6 E
4
),
which negatively influences pump scaling. As such, difficulties are presented when
attempting to use old pump design data to predict the performance of a new blood
pump. Furthermore, high fluid viscosity and the need for small size, high efficiency
and good flow patterns, necessitate a pump that falls outside the conventional design.
Pump performance is directly affected by hydraulic losses. These were suggested to
be a combination between viscous (windage, friction) and non-viscous (blade
thickness, mixing). The hydraulic efficiency of the axial flow blood pumps
investigated did not reach the heights of industrial pumps of the same specific speed,
whereas the centrifugal types were more comparable. This further emphasises the
mismatch of the axial type pump to the cardiac assist application.
Centrifugal pumps incorporating an open or semi-open impeller are also subjected to
losses associated with leakage over the vanes. This was emphasised by Stepanoff
(1957), whereby the magnitude of leakage was dependant on the ratio of impeller
vane height to axial clearance. However, Takano et al. (2000) obtained results
suggesting hydraulic performance and thus leakage loss above the 4mm high
impeller vanes did not increase with a variable axial clearance gap of 1.5 to 5.5 mm
in the Gyro series VAD. This is contrary to results from industrial pumps; however
they attributed the discrepancy to the difference in specific speed and flow
magnitude. Further investigations revealed little difference in haemolysis for the
axial clearance variations, and suggested that the radial clearance gap is much more
predominant in effecting haemolysis levels.
2-31
Centrifugal Impeller Forces
Centrifugal Blood Pump
The force characteristics of a centrifugal blood pump impeller are important in
determining the stiffness capacity of the bearing system responsible for impeller
suspension. Resultant thrust is of particular importance when employing magnetic
bearings to support the rotor, as precise loads must be specified in order to complete
the bearing design (J apikse, Marscher et al. 1997).
The impeller should expect to encounter loads resulting from static and dynamic
hydraulic forces within the pump housing, impact forces from everyday activities
such as walking, and impeller gravitational force.
Impact forces do not usually not exceed 2-3g in everyday life (Tansley, Cook et al.
2000)). Accelerations of 4 - 6g for more than a few seconds may cause blackouts
and death, while decelerations of between 50-75 g will cause fatalities in humans.
Gerhart et al. (2002) performed drop tests of the CorAide VAD to simulate
survivable automotive crash data. Results indicated no change in device performance
following simulated falls from 1.2m and 4m which produced decelerations of 12 -
15g and 35 - 44g in all axes respectively.
The Ventrassist device can withstand dynamic accelerations up to 100 m/s
2
(10g)
before impeller touchdown (Tansley, Cook et al. 2000). Impact loads are further
catered for by an exotic coating on impeller surfaces which allow minimal
touchdown without pump cessation. A CFD study of the hydrodynamic force on the
open type Ventrassist impeller, with varying axial rotor position, was performed by
Qian and Bertram (2000). Predicted radial forces of 0.15-0.3N acted at an angle
between 78 and 90 degrees (toward/parallel cutwater). Axial lift forces were
computed between 0.2 and 1.4N.
A study on radial forces encountered by a centrifugal blood pump impeller Allaire et
al. (1996) determined a maximum resultant radial force of 1.5 N when the axis of
impeller rotation was parallel with the horizontal. Since the rotor static weight was
3.5 N, the force reduction was attributed to the centring effect of water in the
clearance gaps which offset the impeller weight. This phenomenon is experienced
by industrial pumps employing axial flow seals (labyrinth) which produce centring
forces, positive stiffness and damping effects (Allaire, Kim et al. 1996).
2-32
Axial force was the topic for investigation by Takami et al. (1997) on the GYRO
centrifugal blood pump. This pump employs a permanent magnetic coupling
beneath a semi-open vane type impeller and thus a magnetic attraction force exists in
the negative axial direction. This force is offset by the floating hydraulic force in the
positive axial direction, created as a result of asymmetric pressure distribution within
the pump cavity. This force was estimated to range from 10 40 N when operating
the 65mm diameter impeller at 1500 3000 rpm respectively. The actual force was
30N for the cardiopulmonary bypass application (300mmHg) and 10N for ventricular
assistance (100mmHg). These results were used to determine the magnetic coupling
distance, which alters the magnetic attraction force (Takami, Makinouchi et al. 1997)
Axial force was also investigated in a CFD study performed by Curtas et al. (2002).
Centrifugal Industrial Pump
Stepanoff (1957) performed a set of simple radial and axial force measurements in a
centrifugal pump based on impeller geometry, operating head and normalised
capacity. Although comprehensive, this study concentrated on the forces experienced
by the impeller of a centrifugal pump designed for one specific speed. Realising this
shortcoming, Agostinelli et al. (1960) modified the experiments to account for the
effect on radial force of pumps designed for various specific speeds.
Flack et al. (1984) provided a comprehensive literature review on the mechanisms,
measurement and prediction of both static and dynamic radial thrust, while Lorett et
al. (1986) targeted the interaction of impeller and volute, particularly operating at off
design capacity. Guelich (1987) then provided an overview of the source of static
and dynamic forces and techniques to measure them.
Both Adkins et al. (1988) and J ery (1985) examined the effect of a predetermined
amount of static impeller whirl on static and dynamic force production.
Recently Baun et al. (2003) conducted a series of experiments aimed at determining
the effect of various impeller and volute combinations on radial thrust force, with
parallel examination of hydraulic performance. They also analysed the effect of a
statically eccentric impeller located within a circular volute, revealing an optimum
offset position may be obtained to improve hydraulic efficiency and reduce hydraulic
force to levels comparable to conventional spiral volute pumps (Baun, Kostner et al.
2000).
2-33
The following sections describe the experimental techniques and results obtained
from a selection of these studies.
Experimental Techniques
Pressure Tappings
Radial thrust can be measured by recording values of pressure about the impeller
circumference by a number of tappings, and integrating the pressure profile (J apikse,
Marscher et al. 1997).
This method requires simple equipment, however the measurement and integration is
cumbersome. Additionally, the accuracy of this technique is low, since the pressure
measured is at the volute wall only, and is integrated only over the impeller outlet
width. Therefore, the contribution of pressure acting on the shroud and hub faces is
neglected and the resultant forces is generally concluded lower than the actual value
(Guelich, J ud et al. 1987).
Non-uniformities in fluid momentum around the impeller are neglected, since simple
pressure tappings do not account for changes in fluid velocity within the volute.
Resultant radial force calculated using this technique is generally lower than the
actual force encountered by the impeller. To address this issue and improve
accuracy, Pitot-static probes may be inserted into the volute. Static pressure and
velocity profile within the volute can be measured, which when integrated, reveals
static pressure and momentum force (Flack and Allaire 1984).
Bearing Stresses
Forces transmitted from the impeller to the casing are measured by strain gauges or
load cells equipped to brackets supporting the bearings. The setup is calibrated by a
known mechanical imbalance and/or statically loading in the impeller plane. This
technique is the most common method used for force evaluation (Stepanoff 1957;
Uchida, Imaichi et al. 1971; Flack and Allaire 1984; Guelich, J ud et al. 1987; Adkins
and Brennen 1988; J apikse, Marscher et al. 1997).
This method does not reveal static and dynamic contributions to overall force,
instead the resultant of ALL forces acting on the rotor is measured, including the
labyrinth forces (Guelich, J ud et al. 1987).
2-34
Shaft Stresses
Strain gauges may be placed directly on the rotating shaft to measure the resulting
radial forces. Results are similar to those provided by the bearing technique; however
the initial setup is more complex (Flack and Allaire 1984; Guelich, J ud et al. 1987).
Shaft Deflection
Proximity probes may be used to detect the deflection of the shaft in response to
increased impeller force. This method is simple, quick and not much modification is
needed to an existing pump to install the probes. However, accuracy is moderate due
to the variations in bearing clearances (Guelich, J ud et al. 1987).
Magnetic Bearing Load Cells
Supporting the shaft of the centrifugal pump with magnetic bearing creates the
ability to measure impeller forces. By recording the power requirements of the radial
and axial magnetic bearing, the force characteristics may be inferred (J apikse,
Marscher et al. 1997; Baun and Flack 1999). This technique requires a high
magnetic bearing stiffness to reduce any eccentricity caused by changing forces.
Literature Results
The theoretical force characteristic trends described previously are confirmed by
experimentation (Stepanoff 1957; Lazarkiewicz and Troskolanski 1965; Lorett and
Gopalakrishnan 1986; Baun, Kostner et al. 2000; Karassik, Messina et al. 2000;
Baun and Flack 2003).
For example, Baun et al. (2003) produced radial thrust results for four and five vane
impellers in single, double and concentric volutes operating over various flow
capacities. Figure 2-4 presents a normalised capacity versus non-dimensional
measured force. The latter corresponds to the value of thrust factor K in the
empirical equations used to predict radial force.
2-35

Figure 2-4 Experimental Measurement of Radial Thrust Magnitude and Direction
A slight print error was observed in the original diagram. The correct symbolisation requires
the exchange of filled and unfilled symbols representing force characteristic and direction.
(Baun and Flack 2003)
The same group also discovered that thrust characteristics achieved in a spiral volute
casing were replicated in a concentric casing while operating an impeller at a certain
offset distance (Baun, Kostner et al. 2000). Figure 2-5 describes the results obtained
from that study. An impeller with no offset created force characteristics typical of a
concentric casing, while an offset in the general direction of the cutwater (35
o
)
increasingly reproduced spiral volute characteristics. This revealed that radial thrust
is affected by the relative static eccentricity of the impeller within a circular casing.

Figure 2-5 Values of Radial Force Factor (K) for Eccentrically Located Impellers in a
Concentric Casing
(Baun, Kostner et al. 2000)
2-36
2.7 Magnetic Bearings for Rotary Blood Pumps
Maslen et al. (1998) identified a promising method of impeller suspension that
utilises magnetic fields to levitate the impeller in a high clearance envelope.
Wampler et al.(1999) recognise that if the magnetic field is active, complete
suspension of the rotating impeller is possible. Maslen et al. (1998) further declared
that a range of diagnostic information on impeller position and active suspension
force may be extracted.
Magnetic bearing technology boasts non-contact suspension, eliminating any point-
to-point contact. Allaire et al. (1996) and Maslen et al. (1998) realised this technique
provided a mechanism for reduced wear and friction, thus simultaneously reducing
the potential for cell mechanical trauma, degree of generated heat, and sites for blood
stagnation.
Karassik and McGuire (1998) state that bearing power is only needed for magnetic
excitation, and is generally lower than lubrication system associated losses.
Incorporating permanent magnets into the magnetic bearing system (PM biasing),
while using active electromagnets for fine control can further reduce power
consumption.
Chen et al. (1998) also support that bearing configurations consisting of two passive
radial bearings and one active magnetic thrust bearing are most attractive in terms of
reduced power consumption, simplicity and reliability. However, they concede the
physical limits and corresponding performance consequences must be addressed
when integrating the bearing system into the pump. Such limits are apparent when
dealing with disturbance forces which require the bearing to have sufficient strength
and stiffness to keep the rotor levitated. These forces may arise from shock transients
(cough), rotor weight, and hydraulic forces. Some systems attempt to use DC
brushless motor designs to provide rotation. Conventionally, these motors produce
large permanent magnet/stator forces in the axial or radial directions, which are
handled by conventional bearings. However these forces are reduced by the
requirement for larger clearance gaps to allow for blood flow (Xu, Wang et al. 1997).
Ultimately, an increase in the bearing capacity leads to increased magnetic bearing
size. Wampler et al. (1999) suggest that the electromagnets in active magnetic
bearings are generally large and heavy, and require proximity sensors fed back to
2-37
servo circuits. An increased complexity results, and therefore may compromise
reliability. Therefore Schweitzer (1994) insist a comprehensive knowledge of
mechanics, electronics and control is required to fully understand their operation.
Bartha et al. (1999) realised that to provide stability in an active bearing control
system, the precise feedback of rotor positional information along each axis is
essential. One proposed method is self-sensing (sensorless) magnetic bearings,
which need no external position sensors (Maslen and Noh 1996). The position
information is deduced from the air gap dependent properties of the electromagnets.
The magnetic motor-bearing system is required to keep the impeller centred within
the pump clearances whilst providing rotational torque / actuation along all six co-
ordinates (3 translational x,y,z and 3 moments
x
,
y
,
z
). Although all such actuation
is provided magnetically, Maslen et al. (1998) indicate that one co-ordinate is not
fixed and requires a motoring mechanism. This is substantially different from the
bearing system used in the remaining 5 co-ordinates. Developments in magnetic
bearing technology applied to centrifugal VADs have concentrated on implementing
a combination of passive and active magnets to completely suspend the impeller.
Passive Magnetic Bearing
Passive magnetic bearings incorporate an arrangement of permanent magnets for
suspension. Depending on their configuration, passive permanent magnets can be
used as either attracting or repelling radial or axial magnetic bearings. However
Schweitzer et al. (1994) reveal that it is not possible to obtain a stable equilibrium,
and at least one unstable co-ordinate remains. This is the basis of Earnshaws
theorem; It is impossible to maintain a body at a given position in free space with
only magnetostatic forces.
Yamane et al. (1995) suggested that one of the impellers six degrees of freedom can
be supported mechanically; the other five are supported with permanent magnets. In
device shown in Figure 2-6, a top shaped pivot mechanically supports the axial (z)
degree of freedom. The pivot is located at the bottom centre of the impeller,
surrounded by four permanent magnets coupled through the housing to the DC
motor. The radial degrees of freedom are supported by repelling permanent magnets.
The system can work stably without special sensors or controllers due to the
simplicity of permanent magnets.
2-38

Figure 2-6 Monopivot Magnetic Suspension Pump
(Yamane, Nishida et al. 1997)
Chen et al. (1998) orientate two axially polarized permanent magnet rings so the
stationary ring attracts the rotating ring of the rotor (Figure 2-7). Therefore, if the
rings are radially misaligned, a restoring force (reluctance centring effect)
proportional to the misalignment is generated.

Figure 2-7 Radial Restoration Using Permanent Magnets
(Chen, Smith et al. 1998)
Khanwilkar et al. (1996) and Chen et al. (1998) believe the incorporation of a passive
permanent magnet bearing into the system may alleviate the power requirements of
the active magnetic bearing to successfully suspend the pump impeller.
Arrangement of the permanent magnets to counter the generated forces in the
directions of highest magnitude is essential to optimise the bearing efficiency.
2-39
Active Magnetic Bearings
Bearings involving active reluctance or lorenz magnetic forces take the form of
radial (x,y), axial (z) or total (x,y,z,
x
,
y
) suspension, relating to the number of
degrees of freedom (DOF) actively supported. The radial type bearing is thinner, as
the magnetic mechanism is located in the circumferential space. An axial bearing
improves performance due to the ability to incorporate more magnetic material in the
unused axial surface area of the impeller (Masuzawa, Ezoe et al. 2003).
Radial Type
Radial type magnetic motor bearings employ active magnetic forces to suspend the
rotor in the radial (x,y) direction and electromagnetic coupling to provide rotational
torque to the impeller.
Masuzawa et al. (2000) proposed a radial motor-bearing to the reduction in the
controlled number of degrees of freedom (Figure 2-8).

Figure 2-8 Radial Magnetic Motor-Bearing
(Masuzawa, Onuma et al. 2002)
The radial motor-bearing requires placement of the electromagnets in the same plane
as the rotor magnets, allowing a thinner overall shape. These electromagnets are
responsible for controlling two radial directions (x,y), and the desired impeller
rotation about the third axis (
z
). To simplify control of the remaining degrees of
freedom, the axial movement (z) and tilting moments (
x
,
y
) are restricted by passive
stability (Figure 2-9). This design was improved by Masuzawa et al. (2002) using
FEA to optimise the stator. The study also assessed the effect of double and single
volute configurations, concluding that a double volute reduced the radial
displacement and thus radial bearing power from 1.3 to 0.7 Watts.
2-40

Figure 2-9 Principle of Passive Restoring Force
Okada et al. (1997) also created a magnetic/motor bearing that levitates and controls
the impeller in the two radial degrees of freedom (x,y). Rotation about the z-axis (
z
)
is achieved by electromagnets surrounding the circumference of the impeller. A
digital signal processor provides the control of levitation and rotation in this system.
Gap sensors provide feedback on the rotors position, which is used to calculate coil
current from the summation of motor and levitation control currents.
Axial Type
Axial type magnetic bearings employ active magnetic forces to suspend the impeller
in the axial direction (z). These forces can also help to counteract the gyroscopic
coupling moments (
x
,
y
). The remaining DOF are stabilized via other techniques.
Okada et al. (1997) produced a magnetic bearing that controls one degree of freedom
(z). Rotation is controlled by the phase of the magnetic flux between the rotor and
stator, while changing the amplitude of the magnetic flux controls levitation. The
remaining four DOF are passively restricted. Rotation and levitation are controlled
using a digital signal processor (DSP). A gap sensor produces a displacement signal,
which is used to determine the current required for levitation, and added to the
rotational current. The levitation control algorithm is based on a simple proportional
derivative (PD) controller. Only one degree of active control is achieved in this
configuration, and the total stability of levitation was poor. The efficiency of this
arrangement is low, as the motion control requires passive stabilisation of the
remaining four DOF. The main advantage is the relative ease of control
implementation.
Restoring Force
Restoring Force
Rotor
Rotor
Stator
Stator
Axial Displacement
Tilt Displacement
2-41
Masuzawa et al. (2003) are developing a magnetically suspended centrifugal blood
pump with an axially levitated motor (Figure 2-10).

Figure 2-10 Axial Magnetic Motor-Bearing
(Masuzawa, Ezoe et al. 2003)

The impeller is actively controlled in the axial and tilting degrees of freedom, while
relying on passive stability for restriction of radial displacement. Design conditions
demand 6 Watts of power for the motor bearing, assuming hydraulic efficiency of 30
percent while operating at a rotational speed of 2000 rpm and 0.03 Nm torque. To
reduce the magnitude of negative stiffness, the total air gap between top and bottom
stators and the rotor is 3mm. To improve pump hydraulic efficiency, the impeller
and casing axial clearance is reduced to 0.4mm, while the radial volute gap is
1.5mm. Displacement while operating the pump in a mock circuit indicated
sufficient bearing capacity; however bottom impeller touchdown was evident at
increased rotational speeds. The bottom stator was responsible for rotation, while the
top stator controlled tilt only. Therefore, the impeller migrated toward the bottom
stator as torque demand increased, until touchdown resulted. Although radial
movement was contained within the given clearance, a significant movement of 0.6
mm was observed. Further studies of volute pressure distribution were recommended
to assess radial passive stability.
2-42
Total
Total active magnetic bearings utilize electromagnetic forces to support the impeller
in all five stabilized DOF and rotate the impeller about the sixth. The University of
Utah and Virginia have developed a completely levitated and rotated centrifugal type
pump (Allaire, Kim et al. 1996; Allaire, Kim et al. 1996). However, Masuzawa et al.
(2000) warn that this requires a sophisticated control mechanism to control all DOF.
Allaire et al. (1996) successfully designed and constructed a prototype incorporating
a five axis active magnetic bearing system. An active control system is used with an
analogue PID controller to prevent the rotor from contacting the pump housing in the
axial direction. An eddy current sensor provides the rotor position feedback to the
controller. Magnetic bearings have the capability to provide large impeller/housing
clearances in the pump (0.3 1.0 mm), which help to increase flow rates and
minimize induced shear stresses. Furthermore, active control is capable of limiting
vibrations within the range of 0.03 - 0.05 mm. The radial bearing at outlet has a 16
pole, planar, radial bearing stator.
In the model constructed by Maslen et al. (1998), a circular array of horseshoe
magnets is directed at the inlet face of the impeller. They account for three axial co-
ordinates, one translational (
+ve
z) and two moments (
x
,
y
). An 8-pole radial stator
with tapered faces directed at the discharge edge of the impeller account for two
translational co-ordinates (
+ve
/
-ve
x,y) as well as
ve
z. This array of magnets includes
9 electromagnets pre-biased to simplify control.
Motor
When properly selecting a driving motor and its control, the torque characteristics of
the machine to be driven must be considered.
Wampler et al. (1999) transmitted torque via a brushless axial flux gap motor
coupled to the impeller. Permanent magnets embedded in the impeller are rotated by
an electromagnetic field produced by a flat motor stator, commutated using back-
EMF sensing. The flat motor helps to reduce overall size, not to mention minimizing
the air gap. Maslen et al. (1998) used an array of neodymium-iron-boron permanent
magnets embedded into the underside body of the impeller. An associated slotless
10-pole, 3-phase stator embedded in the pump casing provides the magnetic coupling
and driving mechanism at a relatively high efficiency of 75 percent.
2-43
Magnetic Bearing Investigation
As indicated in the review, numerous magnetic bearing configurations are under
development for use in the implantable VAD application. These generally feature
unique characteristics suitable to the geometry of each device.
A number of configurations were therefore considered for potential implementation
in the VAD designs proposed in this thesis. These ranged from radial type magnetic
motor-bearings with outer and inner rotors, to axial type self bearing motors.
The potential success of each VAD design is dependant on the understanding and
correct selection of magnetic motor-bearing types.
Preliminary investigations were conducted on an 8-pole slotless and 4-pole slotted
outer rotor (Kim, Abe et al. 2003) , as well as an 8 pole slotted and 8 pole slotless
inner rotor (Tokumoto, Timms et al. 2002). All configurations were of the Lorenz
force type. Reluctance type bearings were not studied in detail.
A brief summary of this study is outlined below, with further details provided in
Appendix F. A comparison of the operating characteristics of each self bearing
motor investigated is presented in Table 2-4.
Table 2-4 Comparison of Self Bearing Motor Operations Characteristics
Inner Rotor Outer Rotor
SLOTLESS SLOT SLOTLESS SLOT
MAX RPM 5500 2100 - 10,000
MAX EFFICIENCY 89.3% 58% - -
CURRENT-FORCE STIFFNESS 3.5 N/A 11.5 N/A 1.2 N/A 10 N/A
MAX TORQUE 0.17 (Nm/A) 0.49(Nm/A) - -

The investigation revealed that slotless inner rotor type self bearing motors achieve
stable levitation at higher rotational speeds than slotted types. However, slotted
types are characterised by extensively higher current-force stiffness.
The maximum speed of the slotted inner rotor type (2100rpm) is insufficient for
VAD operation. Depending on the impeller geometry, the self bearing motor should
achieve stable levitation at speeds up to 3000rpm. This may be overcome by
improving the magnetic circuit and permanent magnet design to reduce the
destabilising cogging torque.
2-44
Electrical current stiffness in the all slotless types is considered insufficient to
prevent impeller touchdown in the implantable VAD application, especially with the
existing rotor weight. Incorporating a slotted type self bearing motor would allow for
greater bearing capacity (approx 10N/A) to counter hydraulic pressure loads and
external shocks encountered during expected operation. For example, if the
maximum device supply voltage is 5V and the coil resistance is 1 Ohm, the bearing
could generate forces of 50N. This would accommodate a shock of 50G for a 100g
rotor. Torque generation was more than sufficient for both slotted and slot type inner
rotor motor-bearings.
Concerns were raised during the investigation over the passive axial stability of these
self bearing motors, especially in the slotter outer rotor configuration. The lack of
passive axial stiffness generated from the radial active control would not appear
sufficient to accommodate expected hydraulic axial thrust forces generated during
conventional single sided impeller pump operation (Timms, Tan et al. 2004).
Conclusion
A number of magnetic motor-bearing configurations were researched and/or
experimentally investigated to indicate their potential for use in the proposed Bi-
LVAD and Bi-VAD designs.
The slotted type bearings produced a larger suspension capacity, while the slotless
inner rotor bearing could achieve a higher rotational speed than its slotted
counterpart, due to the elimination of destabilising cogging torque. All designs
demonstrated weak passive axial stability.
2-45
2.8 Review Summary
The ageing population of the developed world is accelerating the incidence of heart
failure. The most successful treatment of end stage heart failure, the heart transplant,
is limited by the availability of donor organs. Alternative treatments are under
development; however a successful mechanical assist device would provide a
virtually unlimited supply of universally compatible replacement organs. Previous
trials have demonstrated the benefit of VAD treatment over optimal drug therapy,
however device failure and large physical size reduces their availability to the
general patient population.
Many of the essential design issues for the development of ventricular assist devices
were outlined in the review. The potential for blood trauma must be considered
carefully when attempting to decide on pump features. Regions of stagnation, high
shear and high temperature must be eliminated or confined to acceptable levels.
Mechanical durability is of equal importance if the device implantation period is to
approach the expected lifetime of a transplanted heart. Furthermore, this goal must
be achieved with an anatomically compatible design that is suitable for implantation
into the majority of the general CHF population.
The background flow visualisation study was able to identify regions of recirculation
and stagnation within a scaled up centrifugal blood pump. These results, coupled
with an identified cause for thrombosis found in the literature, prompted the
investigation of a double suction impeller for each VAD application to reduce
stagnation beneath the impeller, as well as highlight the need for careful volute
design for smooth outflow transition.
The current bi-ventricular assistance technique using two devices (LVAD and
RVAD) is limited by the large size of these (usually) pulsatile extracorporeal
devices. The development of an implantable compact single continuous flow Bi-
VAD would increase the application of this form of assistance to encompass the
smaller body surface area patient population. The review supports the aim of Bi-
VAD development, as many studies concluded between 17-60% of patients receiving
LVAD support develop right heart failure. This occurrence can result in up to 30% of
patients succumbing to sepsis and/or multi-organ failure due to high venous
pressures. This onset of RHF after LVAD support was commonly attributed to pre-
2-46
existing pathological conditions. Many authors suggest that this therapy may unmask
right ventricular dysfunction, alter ventricular interdependence, increase pulmonary
vascular resistance and change right ventricle loading. Anatomic ventricular
interactions due to septal shift were not considered responsible for the profound right
ventricle failure encountered in these patients. The introduction of right ventricle
assistance and ultimately bi-ventricular assistance successfully improved cardiac
output is such cases.
Mechanical cardiac devices are classified according to their characteristic outflow
(pulsatile or non-pulsatile), followed by the type of bearings employed (first, second,
third generation). First generation pulsatile devices were identified as relatively large
with a mechanical lifetime below three years. The non-pulsatile devices were
questioned in regard to their continuos flow output, as well as potential for
regurgitation upon pump failure. However their smaller size and longer lifetime has
accelerated these devices to the forefront of current VAD research. These devices
are generally axial or centrifugal in configuration. The smaller size of the axial type
was recognised, however the requirement for higher rotational speeds and stationary
guide vanes were suggested to promote excessive blood trauma. Furthermore, the
typical second generation pivot suspension limits the service life to below five years,
which is not favourable for the application of destination therapy. The centrifugal
pump was commonly recommended as the most suitable type for long term cardiac
assistance, due to its lower rotational speed, higher efficiency and reduction of blood
trauma creating features. Furthermore, these pumps could take advantage of the latest
third generation bearing technology to completely suspend the impeller using
hydrodynamic or magnetic bearing forces. This reduces the number of moving
components, potentially increasing device lifetime to beyond ten years.
The critical components for centrifugal blood pump design were identified in this
review. The importance of pump type and size revealed the suitability of the lower
specific speed centrifugal pump over the axial flow counterpart. The performance of
the centrifugal impeller was found to produce a larger pressure head at lower
rotational speeds for higher vane discharge angles, albeit at the expense of efficiency.
Forward facing vanes were investigated for flow patterns, but not performance.
Larger exit vane widths were also found to increase values of pressure head for a
given rotational speed, due to a reduction of meridional velocity. This
2-47
recommendation departs from conventional industrial pump design, however is
common in the investigated blood pump impeller designs. The effect of slip and
viscous drag should be considered when determining the number of impeller vanes to
be included between the commonly employed impeller shroud and hub. A higher
vane number reduces slip, while a lower number reduces viscous drag, both working
with the shroud and hub to improve efficiency. Centrifugal blood pump inlet and
outlet devices were reviewed. An inlet elbow was described as hydraulically
equivalent to a straight inlet for the low specific speeds; however a flat type inlet
elbow may provide improved anatomical compatibility. Finally, the calculation of
throat area by assuming a value of throat velocity obtained from theoretical
references was identified as the critical parameter for exit volute design.
Since the performance characteristics required of an implantable VAD fall outside
conventional pump design, it is difficult to use old industrial pump data to predict the
performance of a new VAD prototype. Furthermore, there is no large collection of
empirical VAD data, so all new prototypes must be tested. However, from the
collection amassed by one author, a shut off head of 0.5-0.6 is expected for the
LVAD application. Mismatch of the axial type VAD to the application of ventricular
support is emphasised by their inability to match the efficiency of the centrifugal
type. Finally, a discrepancy is apparent between two authors regarding the effects of
varying the axial clearance above the semi-open type impeller vanes, with and
without a change in vane height, on centrifugal pump performance. One conforms to
theory suggesting that efficiency and thus performance would drop in all centrifugal
pumps with an increasing clearance. However the other author discovered no
alteration in performance. This result is not consistent with theory, and therefore
formed the basis for further investigation.
Resultant hydraulic thrust is an important consideration for the design of third
generation VADs that relies on the generation of magnetic or hydrodynamic forces
for complete impeller suspension. Values of hydraulic thrust may be calculated or
obtained experimentally. The prediction of radial thrust relies on experimentally
determined thrust factors for use in calculations. Values of these specific speed
dependant factors are provided by a number of authors. However, they are generally
based on much larger industrial pumps. Since there is limited information available
regarding the practical measurement of hydraulic thrust on centrifugal blood pump
2-48
impellers, the requirement for impeller force measurement in a centrifugal blood
pump application was identified. Such an investigation will provide experimental
results that can be compared to predictions made using each authors thrust factors.
This would identify the most suitable set of thrust factors, and enable the accurate
prediction of hydraulic thrust in future centrifugal VAD prototypes. The bearing
stress technique was subsequently pursued due to the relative high accuracy and ease
of set-up compared to the alternative methods. The inability to easily separate the
static and dynamic axial force components was not considered a problem, since the
relative magnitudes are not expected similar in an implantable VAD. The force
results from the literature confirm the predicted theoretical trends of force and
capacity. This information will be useful for comparison and verification of the
results presented in the later investigation.
Magnetic bearing configurations can incorporate active (electromagnetic) or passive
(PM) impeller support. Active support is generally confined to the radial or axial
DOF for simplicity. This technique allows for larger clearances to improve washout,
and active control to increase suspension forces to counter external shocks.
The ability to control the VAD using feedback stimuli is an important feature for
inclusion in the device, and a suitable evaluation environment should be provided for
validation. The VAD should have the ability to respond to changes in the patient
activity level, as well as incidences of over-pumping and ventricular collapse.
2-49
2.9 Conclusion
This review supports the development of new VAD technology as an alternative to
heart transplantation. The Bi-LVAD and Bi-VAD presented in this thesis can
accommodate the cardiac patient population requiring either left ventricular or bi-
ventricular assistance. The Bi-LVAD double impeller would improve magnetic
suspension capacity, and reduce complications of thrombosis. The Bi-VAD device
would provide bi-ventricular assistance to smaller patients, as the single device is
smaller than the present technique of implanting separate LVAD and RVAD pumps.
To achieve the goal of VAD development, a suitable prototype testing facility is
required. A complete mock circulation loop of the systemic and pulmonary
circulation systems is required to test both VAD prototypes. This facility should have
the ability to replicate varying degrees of left and right heart failure, to assess the
pumps ability to return pathological hemodynamics to normal.
Each pump must be designed with careful consideration of the design issues
presented in this review. In order to meet the hemodynamic requirements of the
vascular system and improve pump flow patterns, a procedure must be adapted to
design the impeller and volute components.
The selection of a third generation magnetic bearing technology for impeller
suspension may alleviate many of the problems associated with earlier generation
devices. To assist in the bearing design, precise loads required for impeller
suspension need to be determined. Many of these loads in the clinical setting are
transient (coughing, walking), however fluid pressures created during pump
operation are permanent, and may result in hydraulic thrust. Measurement of this
thrust will help quantify the exact force requirements of the bearing system to
minimise impeller touchdown.

3-1
Chapter 3
Mock Circulation Loop

The requirement for in-vitro evaluation of left- right- and bi- ventricular assist device
performance prompted the design and construction of a new systemic and pulmonary
mock circulation loop.
This chapter presents aspects for the development of the mock circulation loop,
which includes pulsatile left and right ventricles coupled with vascular compliances
and resistances.
A description of the parameters within the natural circulatory system required for
replication is initially provided. An overview of current basic and advanced mock
loops is then included, before a simplified simulation model is presented. This model
assisted in the development of the physical loop, which is detailed in the following
section. Finally, results are presented that verify the loops ability to replicate the
hemodynamic conditions of the entire cardiovascular system in response to normal
heart function and varying levels of left and/or right heart failure.
This newly developed circulation loop has the potential to provide valuable
cardiovascular device performance feedback prior to expensive and time intensive
in-vivo animal trials.

Chapter 3 - Mock Circulation Loop
3-2
3.1 Introduction
By reproducing the human circulatory system in-vitro, it is possible to refine VAD
designs by ascertaining their effect on circulation. This accelerates the design
process, and is necessary to comply with FDA regulations before clinical animal and
human invivo trials (Patel, Allaire et al. 2003).
Various mock loops have been constructed by a number of research centres for
testing the viability of their VAD design. These loops range from a basic circulation
loop to advanced loops incorporating variable parameters imitating the physiological
parameters of the human circulatory system.
It is an important criterion for the more advanced mock circulation loops to
reproduce human physiological conditions, both healthy and otherwise, without an
assist device. Inserting the VAD will then evaluate the desired improvement of flow
and pressure, analogous to increased perfusion (Patel, Allaire et al. 2003).
3.2 Background - Description of Physiological Parameters
To develop a mock circulation system, all parameters in the human circulatory
system to be reproduced must be identified and understood.
3.2.1 Circulatory System
The circulatory system encompasses the heart and vascular network. Arteries and
veins form this network, which distributes blood to organ and tissue capillaries
before providing a return to the heart (Figure 3-1). Additionally, a small amount of
blood flow leaving the left heart supplies the bronchial tissue and returns directly to
the left heart, bypassing the pulmonary circulatory system. This results in slightly
variable balance of left/right heart output flow. Highest resistance to flow is
experienced in the arterioles, while most blood volume is stored in veins. The
vessels of the vascular network help adjust the blood flow and pressure via a number
of autoregulatory mechanisms. Particularly, the arteries diminish the pressure pulse
wave created by the intermittent heart ejection, while the veins are capacitance
vessels responsible for regulating the rate of blood returning to the heart (Klabunde
2004).
3-3
Kidneys
Legs
Pelvic Organs
Hepatic
Splenic
Trunk
Coronary
Arms
Head
and Neck
HEART
Lungs
Bronchial
Arterial Venous

Figure 3-1 Circulatory System Figure 3-2 Circulatory Pressure Distribution
3.2.2 Blood Volume and Pressure Distribution
Blood pressure is highest in the aorta, and slightly reduces in the distributing arteries.
However, most pressure drop (approx 70%) occurs in the arteriole-capillary section
(Klabunde 2004), as displayed in Figure 3-2.
Total blood volume of an average adult human is estimated at 5000-5600 ml
(80mL/Kg). This volume is tightly regulated by complex mechanisms, one of which
is water and sodium excretion by the kidneys. Blood volume significantly effects
circulatory pressure distribution and cardiac output, and therefore plays an important
role in hemodynamic regulation.
Approximately seventy percent of total blood volume is contained in the veins with
the remaining thirty percent in the arteries (Tyberg 2002). Table 3-1 further details
the relative blood volumes (William, Stevens et al. 2003).
Table 3-1 Blood Volume Distribution
Circulatory Section % of Total Blood Volume Blood Volume
Systemic Artery Volume 16 800 ml
Systemic Vein Volume 64 3200 ml
Systemic Capillary Volume 4 200 ml
Pulmonary System Volume 9 450 ml
Heart Blood Volume 7 350 ml

3-4
3.2.3 Heart Functionality
Cardiac Cycle
The cardiac cycle consists of five phases (Klabunde 2004). Figure 3-3 provides a
view of these phases in relation to pressure distribution and electrical activity.

Figure 3-3 Phases and Pressure for one Cardiac Cycle
(Klabunde 2004)
PHASE 1 Ventricular Filling
a. Rapid Ventricular Filling As the ventricle pressure drops below the atrial
pressure, the A-V valves open and blood re-fills the ventricle.
b. Reduced ventricular filling As the ventricles fill with blood and expand, the
compliance reduces and pressure increases, thus reducing the flow.
3-5
PHASE 2. - Atrial systole
The atrial muscles contract during this phase to propel blood from the atrium to the
ventricle. This accounts for only 10% of ventricular filling during rest and 40%
during exercise, as most filling occurs passively before the atria contract. Back flow
from the atria to supplying veins is prevented by the bloods inertia, as well as a
milking atrial contraction.
PHASE 3. - Isovolumetric Contraction
The valves of the heart are closed and no flow occurs as the pressure in the ventricle
increases. The volume is the end diastolic volume.
PHASE 4 Ventricular Ejection
a. Rapid Ejection When the pressure in the ventricles exceeds the aortic and
pulmonary artery pressures, the aortic and pulmonic valves open and blood is
ejected.
b. Reduced Ejection Ventricular active tension decreases and the rate of ejection is
reduced. Atrial pressures rise gradually due to filling from venous return.
PHASE 5. - Isovolumetric relaxation
The valves close when the pressure in the ventricles reduces below that in the
arteries, preventing backflow. The pressure of the remaining blood in the ventricle
continues to drop, and the volume is the end systolic volume.
3-6
Heart Rate
Heart rate is the number of cardiac cycles per minute (bpm). Rates of 60, 60 and 120
bpm were chosen for rest, treated heart failure and exercise conditions respectively.
Systolic and Diastolic Period
The Systolic period refers to the ventricular contraction time within each cardiac
cycle. This parameter is also referred to as the percentage of the cardiac cycle in
systole, and can range from 30-50% depending on the condition. Diastolic period
refers to the time within each cardiac cycle that the atrium and ventricle relax. The
ventricular diastolic parameter is defined by the remainder of the cardiac cycle
period after ventricular systole. The percentage time in ventricular systole for use in
calculations within this chapter is assumed at 40% for each condition of rest, exercise
and heart failure.
Ventricular Contractility and Relaxation
Contractility refers to the rate at which the ventricle can develop pressure, while
relaxation describes the rate at which pressure falls within the ventricle after systole.
Contractility varies with heart function, increasing for exercise while decreasing in
cases of heart failure. Relaxation is a function of the passive relaxing of the
ventricular wall, and is assumed to be the same for each heart condition presented.
However, some forms of heart failure can influence this parameter.
3.2.4 Vascular Hemodynamics
Hemodynamics refers to the factors influencing perfusion through the circulatory
system. Organ perfusion is driven by an arterial to venous pressure gradient, which
is dependent on vascular resistance. A relationship between Cardiac Output (CO),
blood pressure (P) and vascular resistance (R) is shown in Equation [ 3-1 ].
R
P P
Q
vein artery

=

[ 3-1 ]
Since the left and right hearts operate in series, their long term average flow must not
be different. However, due to the varying properties of the circulatory systems, the
short term average may be slightly different allowing sections of the system to hold
different amounts of blood.
3-7
3.2.5 Physiological Pressures
Arterial Blood Pressure
The ejection of blood from the ventricle into the arterial network results in a
characteristic pressure wave. Pulse pressure (PP) and mean arterial pressure (MAP)
are calculated from the values of systolic and diastolic pressure. Typical systolic
(P
sys
) / diastolic (P
dias
) pressures expected in the left and right circulatory systems are
120/80mmHg and 25/10mmHg respectively.
Pulse Pressure
Arterial pulse pressure (PP) is defined as the difference between the systolic and
diastolic pressures (Equation [ 3-2 ]).
Pulse pressure is affected by a number of parameters, particularly
Vascular resistance Which influences runoff of blood from arteries to veins,
Stroke volume / Heart rate Where a reduction lowers P
dias
, and;
Compliance This affects changes in arterial pressure with stroke volume.
Arteries are relatively compliant, thus dampening the pulsatile output of the
ventricles. Typical values of pulse pressure are 40mmHg and 15mmHg for left and
right systems respectively.
Mean Arterial Pressure
Mean arterial pressure (MAP) is related to cardiac output (CO) and systemic vascular
resistance (SVR) by Equation [ 3-3 ].
MAP is also determined by the measurement of systolic and diastolic pressures.
Since the pressure pulse wave is asymmetrical (systolic and diastolic periods
unequal), the MAP is calculated as per Equation [ 3-4 ].
The mean arterial pressures are 93mmHg for left and 15mmHg for right systems.
dias sys
P P PP =

[ 3-2 ]
SVR CO MAP = [ 3-3 ]
( )
dias sys dias
P P P MAP + =
3
1

[ 3-4 ]
3-8
Venous Blood Pressure
Central venous pressure (CVP) is the pressure in the thoracic vena cava near the right
atrium. CVP, affected by changes in venous blood volume and compliance, is usually
at or near 0mmHg (Klabunde 2004). Pulmonic venous pressure (PVP) is higher than
left atrial pressure to induce flow from the lungs into to the heart (Milnor 1972).
Right
Atrium
Left
Ventricle
Left
Atrium
3 - 6
8-10
120
0 - 8
25
0 - 3
25
10
120
80
AORTA
Right
Ventricle
Pulmonary
Artery
Left
Ventricle
120
0 - 8
Right
Ventricle
25
0 - 3
Left
Atrium
8-10

Figure 3-4 Pressure Distribution within the Chambers of the Heart (Rest)

Figure 3-5 Left Heart Pressure Distribution

3-9
Mean circulatory pressure (P
mc
) is the blood pressure maintained within the
cardiovascular system when cardiac output (CO) is zero. It is directly related to the
lumped vascular compliance and blood volume. P
mc
directly affects venous return
and consequently, cardiac output. For example, if blood volume is decreased,
cardiac output will reduce, causing autoregulatory mechanisms to decrease
compliance to restore P
mc
until the lost volume is replaced (Guyton 1971). The
typical value of P
mc
is 7mmHg (Guyton 1971; Berne, Levy et al. 2004; Klabunde
2004) and does not vary more than
+
/
-
1mmHg for normal resting heart function
(Guyton 1971). P
mc
increases with exercise due to muscle contraction, also known as
the skeletal muscle pump. Heart failure also results in elevated P
mc
, since
autoregulation mechanisms increase blood volume and decrease venous compliance.
Chambers of the Heart
Pressures within the heart chambers vary throughout each cardiac cycle. These
pressures are described for systolic (Top) and diastolic (Bottom) phases in Figure
3-4 for resting conditions (Klabunde 2004). The pressure variations within the
chambers of the heart are described in Figure 3-3 and in further detail for the left
heart in Figure 3-5. It can be seen from Figure 3-5 that atrial pressure raises slightly
during the atrial systole phase (a), as the atria contract. Atrial pressure also slightly
increases just after ventricular systole (c) as a result of the transferral of pressure
across the closed, but compliant, mitral valve. Atrial pressure then increases slowly
during the systolic phase, as venous return increases the blood volume in the atria
(v). Ventricular pressure increases rapidly during ventricular systole, reaching a
maximum before returning to the initial diastolic phase value. The ventricular
pressure then increases to the value of atrial pressure over the remainder of the
diastolic phase, with the final pressure signifying ventricular preload.
3-10
Summary of Pressure Distribution
Figure 3-6 and Figure 3-7 graphically display the pressure distribution throughout
the systemic and pulmonic vascular trees respectively. Table 3-2 summarises the
values of pressure throughout the cardiovascular system for the condition of rest.
These values were targeted for reproduction by the mock circulation rig. Table 3-3
summarises the mean circulatory pressure values selected for resting, left heart
failure and exercise conditions in the mock circulation rig.

Figure 3-6 Systemic Pressure Distribution Figure 3-7 Pulmonic Pressure Distribution

Table 3-2 Resting Pressure Distribution throughout the Vascular Tree
Table 3-3 Mean Circulatory Pressures for Rest/LHF/Exercise

Pressures
Pdiastolic
(mmHg)
Psystolic
(mmHg)
Mean P
(mmHg)
Left Atrium (LAP) 8 10 9
Left Ventricle (LVP) 0-8 120 -
Aortic (AoP) 80 120 93
Systemic Veins (SVP) 10 10 10
Right Atrium (RAP) 3 6 4
Right Ventricle (RVP) 0-6 25 -
Pulmonary Artery (PAP) 10 25 15
Pulmonary Veins (PVP) 9 12 10
Rest LHF Exercise
Mean Circulatory (P
mc
) 7 20 20
3-11
3.2.6 Compliance
Compliance (capacitance) is related to the ability for a vessel to distend when
encountering a change in blood volume. Figure 3-8 displays the behaviour of non-
compliant and compliant vessels in response to systolic and diastolic conditions.
Compliance is defined as a change in volume for a given change in pressure as
described by Equation [ 3-5 ] and shown in Figure 3-9. It is therefore related to the
ease with which a change in volume causes a change in pressure (Klabunde 2004).
When applied to the circulatory system, it refers to the ability for the vessels to
expand and contract under an applied pulse pressure (Figure 3-8). This feature aids
the heart in its pumping duty (Berne, Levy et al. 2004).
Arterial pressure is increased during systole and is partially maintained during
diastole due to the rebounding nature of the expanded arterial walls. The degree to
which the arterial walls rebound depends on the elastic properties of the artery, and is
deemed the arterial compliance. If the artery walls were rigid tubes, simulating low
compliance, no flow would occur during diastole. Additionally, the pressure in the
vessels would vary from an increased max systolic pressure to zero, as the
damping effect is removed, resulting in a greater amount of work required by the
heart. Instead, a level of compliance is observed, resulting in a continuous flow rate
of blood further down the circulatory system tree, and reduced heart work near to
that of a continuous pumping system (Berne, Levy et al. 2004).
Diastole
Non-
Compliant
Systole
Diastole
Compliant
Systole

Volume
Slope =Compliance

Figure 3-8 Compliance (systole and diastole) Figure 3-9 Definition of Compliance

P
V
C
=

[ 3-5 ]
3-12
Values of compliance are hard to determine, with the most common technique
relying on the measurement of pulse pressure and stroke volume. Compliance varies
throughout the population, with older people characterised with lower compliance
due to stiffening of arterial walls. Compliance can also be regulated in an individual
by altering the vascular tone, since the activation of smooth muscle fibres within the
arteries changes compliance. Compliance is not linear in biological systems, and
decreases with increasing volume, as the blood vessels have an elastic limit.
Arterial Compliance
Typical arterial compliances have been documented between 1 and 2 mL/mmHg for
the systemic arteries and 1 - 8 mL/mmHg for the pulmonary arterial system.
Therefore, these values were used as boundaries for compliance values used in the
mock circulation rig.
Arterial compliance may also be calculated theoretically if stroke volume (SV), pulse
pressure (PP) and degree of microcirculation runoff is assumed. Rapid ejection of
blood from the ventricle as it contracts expels 80% (56mL) of the stroke volume
(70mL) and takes up to 16% of the cardiac cycle (Berne, Levy et al. 2004). Since the
flow through the capillaries is constant, 16% (11.2mL) of the blood exits the arterial
side during this time. Equation [ 3-6 ] describes a calculation of systemic and
pulmonary arterial compliance, using the assumed value of PP (40mmHg).
Table 3-4 Arterial Compliance

Systemic Arterial Compliance Pulmonary Arterial Compliance
1.14 ml/mmHg (Papaioannou, Mathioulakis et al.
2003)
1ml / mmHg (Donovan 1975)
1.0ml/mmHg (Donovan 1975) 4.8 ml/mmHg (Ferrari, Gorczynska et al. 2001)
1.44ml/mmHg (William, Stevens et al. 2003) 2-4 ml/mmHg (Milnor 1972)
1.8ml/mmHg (Ferrari, Gorczynska et al. 2001) 2 ml/mmHg (Noordergraaf 1978)
1-2 ml/mmHg (Noordergraaf 1978)

mmHg
ml
mmHg
ml
Pulmonary
mmHg
ml
mmHg
ml
Systemic
98 . 2
15
8 . 44
Compliance rterial
12 . 1
40
8 . 44
Compliance rterial
= =
= =
A
A

[ 3-6 ]
3-13
Venous Compliance
Values of venous compliance published in the literature are given in Table 3-5.
Again, these values were used as a guide for use in the mock circulation rig.
Systemic venous compliance (SVC) is assumed to be 19-20 times that of systemic
arterial compliance (AoC) (Tyberg 2002; Berne, Levy et al. 2004; Klabunde 2004),
therefore SVC may be calculated using Equation[ 3-7 ].
Table 3-5 Venous Compliance
Systemic Venous Compliance Pulmonary Venous Compliance
10ml/mmHg (Donovan 1975) 5ml / mmHg (Donovan 1975)
50-200 ml/mmHg (Noordergraaf 1978) (William,
Stevens et al. 2003)
6 ml/mmHg (Milnor 1972)
4 ml/mmHg (Noordergraaf 1978)

mmHg
ml
mmHg
ml
4 . 22 20 12 . 1 Compliance Venous ystemic = = S

[ 3-7 ]
3.2.7 Resistance
The resistance to blood flow in the vascular network is predominantly derived by
vessel diameters and the network organisation (series/parallel). Changes in local
vessel diameters allow organs to regulate the amount of blood flow to meet
metabolic needs of the tissue. Vessel diameters are controlled by the secretion of
vasoconstriction and vasodilation substances (Klabunde 2004). Resistance is the
predominant factor controlling afterload, and is defined by Equation [ 3-8 ].
The majority of resistance is developed by the inherent resistance caused by the area
of the blood vessels. That is, for a particular pressure differential (P
1
-P
2
), a maximum
fluid velocity (v
2
) may be calculated using Bernoullis equation (Equation [ 3-9 ]).

Q
P P
R
2 1
=
[ 3-8 ]
2
2
2
2
2
1
2
1
1
1
2 2
z
g
v
g
P
z
g
v
g
P
+ + = + +

[ 3-9 ]
3-14
Since flow (Q) equals this set velocity (v
2
) multiplied by the vessel cross-sectional
area (A) (Equation [ 3-10 ]), altering the area (A) will result in various flow rates
(Q) for the same pressure differential, and thus resistance (R) will vary.
Total resistance should be evaluated by adding effects of factors such as fluid
viscosity (). The nature of the flow (turbulent/laminar) will dictate the magnitude of
these effects. For example, resistance of laminar flow through a pipe vessel radius (r)
and length (l) is described by Equation [ 3-11 ] (Berne, Levy et al. 2004):
A number of different conventions are used to display values of resistance. The most
common are Peripheral Resistance Units (PRU) (mmHg.s.ml
-1
) and the more
medically traditional dyne.s.cm
-5
.
Systemic Vascular Resistance
Systemic vascular resistance (SVR), or total peripheral resistance (TPR), is a
measure of the resistance to blood flow incurred by the arteries, capillaries and veins
of the systemic circulatory system. SVR consists of the sum of each individual
component resistance (arteries, capillaries, veins), and is a measure of the difference
in mean aortic (mAoP) to right atrial pressure (RAP) divided by CO.
Values of SVR for a healthy patient from rest to exercise range from approximately
1400 to 700 dyne.s.cm
-5
respectively (Burton 1965; Milnor 1982). SVR is slightly
higher for patients suffering heart failure (1596-1862 dyne.s.cm
-5
) due to
compensatory mechanisms (Patel, Allaire et al. 2003). Equation [ 3-12 ] describes a
sample calculation of SVR while Table 3-6 displays the guiding values for
replication in the mock circulation rig.
Table 3-6 Systemic Vascular Resistance
5
. . 1386
min .
18
5
) 3 93 ( ) (
= =
=
cm s dyne
L
mmHg
CO
mRAP MAP
SVR
[ 3-12 ]
A v Q =
2

[ 3-10 ]
4
8
r
l
R
=

[ 3-11 ]
Rest Heart Failure Exercise
1.1 PRU
(1463 dyne.s.cm
-5
)
1.35 PRU
(1800 dyne.s.cm
-5
)
0.54 PRU
(718 dyne.s.cm
-5
)
3-15
Pulmonary Vascular Resistance
Pulmonary Vascular Resistance (PVR) is a cumulative measure of the resistance in
the arteries, capillaries and veins of the pulmonary system. Although the vessel
diameters are similar to the systemic system, the distance the blood must travel
within the vessels is smaller. For example, the length of the Aorta is approximately
50cm, while the Pulmonary Artery is just 5cm (Milnor 1972). PVR is therefore
expected to be much less.
Values of PVR for a healthy patient during rest and exercise conditions range
between ~50 to ~200 dyne.s.cm
-5
(Milnor 1972; Slife, Latham et al. 1990). Increased
resistance to flow is again found in patients suffering heart failure. A sample
calculation of PVR is shown by Equation [ 3-13 ] while Table 3-7 specifies the
values required for replication in the mock circulation rig.
Table 3-7 Pulmonic Vascular Resistance

Individual Component Resistances
Cardiac output is a measure of the volume of blood pumped per minute of operation.
However, since blood ejection is intermittent, the actual instantaneous local blood
flow in each section varies considerably. Establishing the actual blood flow
throughout each local section for each pulse is essential to ascertain the individual
local resistances for a given pressure. This is important when selecting the
appropriate pipe sizes throughout the mock circulation rig.

Rest Heart Failure Exercise
0.08 PRU
(106 dyne.s.cm
-5
)
0.12 PRU
(160 dyne.s.cm
-5
)
0.031 PRU
(41 dyne.s.cm
-5
)

5
. . 93
min .
2 . 1
5
) 9 15 ( ) (
= =
=
cm s dyne
L
mmHg
CO
mLAP mPAP
PVR
[ 3-13 ]
3-16
3.2.8 Cardiac Output
Cardiac output (CO) is dependant on a number of integrating factors. CO relates
directly to Heart rate (HR) and Stroke Volume (SV) by the following relationship
(Equation [ 3-14 ]).
Furthermore, Stoke Volume (and thus indirectly CO) is directly dependant on
Venous Return (VR),
Afterload, and
Contractility
In short, an increase in VR increases end diastolic volume (EDV), a reduction in
afterload reduces end systolic volume (ESV), and an increase in contractility allows
for more blood ejection, again reducing ESV. These volume changes affect SV as
defined by Equation [ 3-15] and shown in Figure 3-10.

100
0
200
0
100
LV Volume (mL)
Venous
Return
200
Control
Loop

Figure 3-10 Development of Ventricular Stroke Volume

HR SV CO = [ 3-14 ]
ESV EDV SV = [ 3-15 ]
3-17
The reversal of these conditions (rest, high blood pressure and heart failure) results in
a reduced SV.
The most important factor affecting CO is the mean circulatory pressure (P
mc
). This
pressure dictates the rate of ventricular filling during the diastolic phase, and
consequently EDV and finally SV. In other words, a low P
mc
will cause reduced CO,
whereas high P
mc
will increase CO considerably in a normally functioning heart.
Furthermore, an increased HR does not change CO for a given P
mc
. Instead, a lower
SV occurs, since the rate of diastolic filling is unchanged, and the ventricle does not
refill to the previous ESV.
Since the heart has a limited EDV due to size and capacity, a further increase in P
mc

would cause the ventricle to fill completely early in the diastolic phase, and further
ventricular filling would cease during the latter part of the diastolic phase. To
counter this situation, HR increases, providing significant increases to CO. This is
experienced in exercise conditions, where an increased HR and P
mc
are observed.
The body therefore has methods to regulate cardiac output in response to varying
physiological needs. Interactions of these techniques will be explained in further
detail in subsequent sections.
Typical values for parameters directly affecting CO under conditions of rest, exercise
and heart failure are given in Table 3-8. The table also presents the values of CO
chosen for simulation in the mock circulation rig.
Table 3-8 Parameter affecting cardiac output
Cardiac output is often related to patient size or body surface area (BSA), and is
termed Cardiac Index (CI) (Equation [ 3-16 ]);
Typical resting values for CI range from 2.5 to 4.0 (L/min) / (m
2
).
Rest Exercise Left Heart Failure
EDV 50 ml 50 ml 192 ml
ESV 133 ml 133 ml 150 ml
SV 83 ml 83 ml 42 ml
HR 60 bpm 120 bpm 60 bpm
CO 4.9 L/min 9.9 L/min 2.5 L/min
BSA
CO
CI =

[ 3-16 ]
3-18
Effect of Venous Return on Cardiac Output
Mean Circulatory Pressure (P
mc
) immediately increases after the onset of exercise
due to the effect of contracting muscles, thus setting up a larger pressure gradient
back to the heart, and venous return increases accordingly. The one-way valves
inside the veins prevent retrograde flow and promote the return of blood to the heart
(Klabunde 2004). The rise in P
mc
and consequent rise in SVP is halted by a change in
cardiac function. SVP is therefore maintained by a balance between heart function
and peripheral circuit conditions. The heart will adjust to an increase in venous return
during exercise via two mechanisms (Notarius and Madger 1996).
The first relates to the mechanism described by the Frank-Starling Law
1
, by which
the increase in venous return results in an increase in the end diastolic volume
(preload) in the ventricle, thus leading to a larger stroke volume and ultimately
cardiac output. An increase in venous return implies that a change in peripheral
circuit factors must have occurred (pressure gradient, resistance, compliance etc)
(Klabunde 2004).
The second is associated with an increase in cardiac function (contractility, heart
rate), thus leading to an increase in CO and VR. Both mechanisms can occur
simultaneously to adapt to a change in VR, however if CO is predominately due to
changes in the peripheral circuit, then the SVP will increase. Alternatively, if the CO
increase is predominantly due to changes in heart function, SVP will drop.
To balance the P
mc
, both mechanisms must complement each other (Notarius and
Madger 1996). Thus an initial increase in CO is most likely due to the Frank-Starling
mechanism. A further rise in SVP is prevented by the adaptations in cardiac
response (which act to reduce SVP) until a balance is achieved as exercise continues.

________________________________
1 Frank Starling Law describes the ability of the heart to increase its force of
contraction in response to an increase in preload (cause by an increased EDV). The
increased preload stretches the cardiac myocytes allowing them to contract more
forcefully and thus eject the additional volume.
3-19
Effect of Contractility (Inotropy) on Cardiac Output
Changes in stroke volume can be achieved by the alteration in cardiac muscle
contractility. For example, improved contractility increases the rate at which
pressure is developed in the ventricle, and consequently results in additional blood
ejection. This leads to a reduced ESV, increased SV and hence increases CO.
Changes in contractility produce significant variations in ejection fraction, which is a
clinical term describing the ratio of Stroke Volume (SV) to the End Diastolic
Volume (EDV), and is used to evaluate the inotropic state of the heart. Heart failure
patients experience a reduction in contractility, leading to a reduced ejection fraction
and stroke volume. This results in a larger amount of blood remaining in the ventricle
at the beginning of diastolic filling (preload). An increase in this preload to a
pressure exceeding 20mmHg in the left ventricle can result in pulmonary congestion
and oedema, as the pressure gradient from right to left heart is reduced and
consequently flow congests in the lungs.
3.2.9 Cardiac / Vascular Coupling
Systemic Vascular Function
The heart can be described as a pump that transfers blood from a highly compliant,
low pressure reservoir (venous) to a low compliant, high pressure reservoir (arterial)
(Tyberg 2002). As previously stated, when there is zero cardiac output, the mean
circulatory pressure is approx 7mmHg (Berne, Levy et al. 2004; Klabunde 2004).
As the heart starts beating and cardiac output increases, blood is transferred from the
venous to arterial vessels. Consequently, the SVP and RAP decrease, and the aortic
pressure (AoP) increases. This produces a pressure gradient across the body vascular
resistance, causing a flow of blood from the arteries to veins. The degree that the
arterial pressure increases and RAP decrease about the P
mc
is determined by the
venous (C
v
) and arterial (C
a
) compliance (Tyberg 2002). Again, the typical ratio of
venous to arterial compliance is nineteen (Tyberg 2002; Berne, Levy et al. 2004;
Klabunde 2004).
To illustrate this process, when CO is 5l/min, arterial pressure increases to
102mmHg (7 mmHg +5*19) and venous pressure decreases to 2mmHg (7 - 5*1).
However, if flow was to increase further to 7 L/min, venous pressure would drop to
3-20
0mmHg and no increase in cardiac output would be possible since the resulting
pressure would be negative and the vessels would collapse (Tyberg 2002; Klabunde
2004).
Instead, the body has two alternative mechanisms to allow for greater cardiac output
and prevent the collapse of the veins. The first being an increase in total blood
volume contained in the circulation, as achieved by the conservation of salt and
water by the kidney. The second is a reduction in vascular volume by
vasoconstriction and reduction in venous compliance. Both of these regulatory
mechanisms raise P
mc
. This is illustrated in Figure 3-11 where it is observed that CO
is dependant on P
mc
and RAP. Furthermore, increasing SVR for a given P
mc
affects
the slope of RAP to CO. This demonstrates the ability to regulate CO by changes in
vascular resistance. (Guyton 1971; Klabunde 2004).
Pmc
V Cv
V Cv
PRA (mmHg)
5
0
Pmc
SVR
PRA (mmHg)
5
0
SVR

Figure 3-11 Effect of Volume, Vascular Compliance and Resistance on P
RA
Cardiac Function
According to the Frank-Starling Law, an increase in RAP increases right ventricular
preload which in turn increases CO from the right ventricle. This transfers blood
volume to the pulmonary circuit which increases LAP, and therefore increase left
ventricular preload. Consequently, Left ventricular output increases. This
autoregulatory mechanism continues until a balance is reached. As previously
identified, this process is attributed to the increase in myocyte contractility in
response to increased preload, and is illustrated as the cardiac function curve in
Figure 3-12. The path of the cardiac function curve is dependant on the inotropic
state of the heart (Guyton 1971; Klabunde 2004).
3-21
5
0
10
0 10
Normal
Enhanced
Depressed
PRA (mmHg)
5
0
10
0 10
Cardiac Stimulation
PRA (mmHg)
B
C
A
Cv

Figure 3-12 Cardiac Function Curves Figure 3-13 Interaction between Cardiac
and System Function Curves
Interaction of Cardiac and Systemic Function
By superimposing the systemic vascular function curve on the cardiac function
curve, the operating point of the circulation is identified (Figure 3-13). Cardiac
output is therefore altered by changing systemic and/or cardiac function. For
example, an increase in cardiac function (inotropy/heart rate) from (A) moves the
cardiac function curve up and to the left, resulting in a small increase in CO and
slight reduction in RAP (B). If however, this occurs in conjunction with a change in
systemic vascular function (e.g. reduced compliance), cardiac output is dramatically
increased (C) (Guyton 1971; Klabunde 2004). It is this ability to regulate cardiac
output by altering cardiac or systemic parameters that allows the body to
accommodate varying degrees of cardiac or systemic failure.

Figure 3-14 Compensatory mechanisms in response to heart failure

Heart Failure
A failing heart loses its ability to pump forcefully, which translates to a loss of
contractility. Figure 3-14 describes the cardiac and systemic response to this
condition. The depressed inotropic state results in the cardiac function curve shifting
down and to the right, and consequently CO reduces to critical levels (B). This is
5
0
10
0 10
PRA(mmHg)
B
C
A
Cardiac
Failure
20
V Cv
SVR
3-22
somewhat compensated by the Frank-Starling mechanism, as RAP is increased as a
result. However, compensatory mechanisms are also invoked by the systemic
vasculature to further increase CO. In brief, blood volume increases and venous
compliance decreases (to increase P
mc
) while SVR increases to reduce the slope.
Thus, cardiac output is increased at the expense of elevated RAP (C). This is not the
ideal solution since increased RAP or LAP causes edema, as blood backs up in the
systemic (right heart failure) or pulmonary (left heart failure) systems respectively
(Guyton 1971; Klabunde 2004).
Left Heart Failure
Left heart failure leads to increased mean pulmonary pressure and reduced mean
systemic pressure. Basically, blood is transferred from the systemic to pulmonary
systems due to the healthier right ventricle. The failing left ventricle cannot
effectively remove this blood, which then backs up in the lungs. This excess fluid
increases the mean pulmonary pressure, and thus LAP, causing an increase in left
ventricular output due to the Frank-Starling Law. However, if this pressure increases
above 28mmHg (the colloid osmotic pressure of the plasma), fluid filters into the
interstitial spaces and alveoli. Pulmonary congestion occurs, and if remained
unchecked, a fatal condition known as pulmonary edema develops.
3-23
Right Heart Failure
The consequence of unilateral right heart failure is not severe systemic edema, but
predominantly reduced CO. Given that the pulmonary blood volume is much less
than the systemic volume, and that the compliance is much higher in the systemic
circuit, a smaller volume transfer of blood from pulmonary to systemic circuits
causes a relatively small increase in SVP. Hence, the risk of edema is low. Venous
return to the right atrium is therefore not increased and the Frank-Starling Law is not
observed. Instead, CO remains low and the potential for cardiac shock develops.
Systemic Failure
Systemic failure refers to the inability of the systemic vasculature to alter its
characteristics. This includes arteriosclerosis, which reduces the vessels compliance
and increases systemic vascular resistance.
Preload
Preload is defined as the initial stretching of ventricular cardiac myocytes prior to
contraction. As this is difficult to measure, the more common techniques used to
evaluate preload is via end diastolic volume (EDV) or end diastolic ventricular
pressure (LVP
ED
). These methods are not ideal as they depend on the condition of
the ventricle, i.e. ventricular dilation affects EDV whereas compliance affects
pressure. Preload is dependant on the volume of blood that fills the ventricle at the
end of the passive filling diastolic heart phase. This blood volume depends on
factors such as venous pressure, venous return and heart rate (Klabunde 2004). As
already noted, the effect of increased preload is to increase CO via the Frank-Starling
Law.
Afterload
Afterload refers to the load on the ventricle caused by the vasculature, and is
predominantly dependant on the vascular resistance. The effect of afterload is to
alter the stroke volume of each heartbeat. An increase in afterload will result in
reduced blood volume ejection from the ventricle, and therefore a greater ESV. The
EDV and consequently preload then increases slightly, which stimulates the Frank-
Starling mechanism, to compensate the increased afterload by increasing heart
functionality and improving stroke volume (Klabunde 2004).
3-24
3.2.10 Autoregulation
Autoregulation of blood flow is defined as the ability of vasculature to maintain
perfusion rates despite fluctuations in pressure (Klabunde 2004). If the perfusion
pressure to an organ decreases, a corresponding decrease in flow is observed.
Metabolic or myogenic mechanisms are then activated to dilate the vessels, reducing
resistance and therefore increasing perfusion.
Autoregulation is most efficient in critical organs (Brain, myocardium). Therefore,
despite vessel constriction in response to body trauma (shock etc.), perfusion to these
critical organs is maintained. Perfusion to non-essential organs (skeletal) is reduced,
ensuring adequate oxygen delivery to critical areas (Klabunde 2004).
Regulation of cardiac output
Cardiac output is regulated by many autoregulatory mechanisms.
Left and Right cardiac balance is automatically regulated by the Frank-
Starling Mechanism.
A change in myocardial contractility helps to alter overall CO by adjusting
the stroke volume.
The sympathetic and parasympathetic nervous systems regulate HR in
response to changing physiological demands.

Arterial Baroreceptors
Blood pressure in the arteries is controlled by the negative feedback system, referred
to as the Baroreceptor reflex. Baroreceptors are small pressure sensors located in
the aortic arch and carotid arteries. These receptors respond to changes in wall strain,
and thus pressure, by firing impulses to the brain. If the MAP or PP decrease, the
firing rate of the baroreceptors decreases and vessel vasoconstriction results, leading
to partial restoration of arterial pressure (Klabunde 2004).
3-25
3.3 Literature Review Prototype VAD Testing
Ventricular assist programs often employ mock circulation loops to test device
iterations prior to animal and clinical trials. Present mock circulatory loops can be
generally classified as simple and non-pulsatile in nature, or advanced, including an
artificial ventricle to create pulsatile flow. This section provides a review of the
literature detailing the current techniques used to simulate the human circulatory
system in-vitro. The difficulties experienced while attempting to reproduce heart
failure in an animal model are also included, to highlight problems which may be
alleviated with a suitable mock circulation system..
3.3.1 Basic Mock Circulation Loops
The most basic loop facilitates the ability to test pumps performance characteristics.
I.e. pressure head, flow rate and efficiency at various rotational speeds. These loops
incorporate a flow meter, inlet and outlet pressure transducers, a resistance valve and
a reservoir (Makinouchi, Ohara et al. 1994; Yoshino, Uemura et al. 2001;
Yoshizawa, Sato et al. 2002) (Figure 3-15). Water is used as the pumping medium
at room temperature, piped through 3/8 (9.5mm) tubing (Takami, Yamane et al.
1997; Linneweber, Chow et al. 2001). The basic loop is the quickest and most
efficient means of testing a newly designed pumps ability to meet the physiological
requirement of the body. Although refinement of the loop by introducing different
pumping mediums improves the validation of results, it is not possible to determine
the effect on pump hemodynamic performance and operation when introduced into
the intended pulsatile system, the human circulatory system.

Figure 3-15 Basic Test Loop
P
in

P
out
Flow
Meter

Valve
Reservoir
Pump
3-26
3.3.2 Advanced Mock Circulation Loops
To investigate pump performance in a pulsatile environment, it is necessary to
introduce features into the mock circulation loop to recreate parameters of the native
circulation system. Bearnson et al. (1996), Iijima et al. (1997), Pantalos et al. (1998)
and Kikugawa et al. (2000) all created mock loops incorporating; Pulsatility,
Temperature, Atrial Pressure, Arterial / Venous compliance and Peripheral resistance
(Figure 3-16). These mock loops were developed to evaluate LVAD performance,
and therefore use a systemic mock loop only. Therefore, the effect of the device on
right heart function and pulmonary circulation can not be evaluated. Furthermore,
the techniques of pulse replication do not faithfully adhere to the Frank-Starling law.

Figure 3-16 Advanced Mock Circulation Loop
3.3.3 Current Mock Loops
The Donovan mock circulation loop was developed in 1975 (Donovan 1975) as an
in-vitro rig to test Total Artificial Hearts. Consequently, the rig does not incorporate
an artificial ventricle, and is therefore not suitable for evaluating the performance of
assist devices. It may however be adapted to further advance the basic mock
circulation loops. As such, the Donovan loop is regularly used by research centres for
VAD testing today (Bearnson, Olsen et al. 1996; Bullister, Reich et al. 2002; Chung,
J oo Lee et al. 2003; Olegario, Yoshizawa et al. 2003). Recent mock loops have
attempted to address the limitations presented. In particular, Pantalos et al. (2004)
developed an artificial ventricle that adheres to the Frank-Starling Law, however
unfortunately it is limited to the systemic circulation system only (Figure 3-17).
P
out
Flow Meter
Peripheral Resistance
Valve
Aortic
Compliance
P
in

Pump
Atrial
Reservoir
Latex
Sac
Air
Temperature Bath
(37
o
C)
3-27

Figure 3-17 Mock Circulation Loop (Pantalos, Koenig et al. 2004)
Wu et al. (2004) identified the need for pulmonary and systemic loop simulation
(Figure 3-18); however the artificial ventricle induces fluid into the chamber by
negative pressure, and thus does not solely rely on passive diastolic filling.

Figure 3-18 Mock Circulation Loop (Wu, Allaire et al. 2004)
3-28
Physiological Condition
Both Pantalos et al. (1998) and Kikugawa et al. (2000) believe a mock circulatory
system should have the ability to alter hemodynamic characteristics to emulate
varying degrees of heart function under several physiological conditions. In light of
this, Pantalos et al. (2004) attempted to simulate normal, failing and recovering heart
function for resting conditions in a systemic only circulation loop. Furthermore, Wu
et al. (2004) used a loop to examine the reproduction of rest, sleep and exercise
conditions with five levels of heart function.
Cardiac Functionality Simulation
Pulsatile Ventricle
Heart function is sometimes limited by the use of a sucking type diaphragm or roller
pump, which creates a negative pressure to induce fluid into the ventricular chamber.
The pulsatile effect of the natural heart is critical for cardiovascular simulation. This
is particular important when evaluating ventricular assist devices. Pulsatility may be
achieved by using a pneumatically driven ventricle consisting of a flexible membrane
or piston cylinder, and tilting disc one way valves to simulate the effect of the mitral
and aortic valves (Iijima, Inamoto et al. 1997; Vermette, Thibault et al. 1998;
Kikugawa 2000; Kawahito, Takano et al. 2001; Endo, Araki et al. 2002; Olegario,
Yoshizawa et al. 2003; Patel, Allaire et al. 2003; Pantalos, Koenig et al. 2004).
However, an important requirement of any mock ventricle is its ability to reproduce
the Frank-Starling Law (Pantalos, Koenig et al. 2004). Altering the functional state
of the heart (i.e. contractility) produces a variation in preload, afterload and cardiac
output conditions (Kikugawa 2000).
Left Ventricular Pressure
Left ventricular pressure is often controlled by pulsed air pressure driven into the
space surrounding the flexible artificial ventricle. Patel et al. (2003) and Pantalos et
al. (2004) modified physiological condition by changing the driving air volume and
impulse rate, simulating contractility and time in systole respectively.
Heart Rate, Systolic Period
Patel et al. (2003) identify 60-70 bpm as a healthy patients HR at rest, with a
systolic period of 45%. On the other hand, heart failure patients HR is generally 60-
80 bpm with a systolic period of 35%. However, investigations using the mock loop
3-29
developed by Wu et al. (2004) used a common 40% systolic period and 60 bpm HR
for rest and heart failure, while HR was increased to 95 bpm for exercise conditions.
Furthermore, tests conducted on a mock loop developed by Pantalos et al. (2004)
used a common 37% systolic period for all physiological heart conditions. In this
study, HR was varied from 80 to 120bpm for each physiological condition of rest,
heart failure and recovery.
Atrial Reservoir
The atrial reservoir allows for conservation of venous return fluid momentum despite
the intermittent nature of the atrial/ventricular valves. It is located in the loop section
feeding the simulated ventricle. It can be a chamber open to atmosphere, with the
fluid level relative to the pump centreline determining LAP (Weber, Doi et al. 2002).
Vascular Simulation
Resistance
Reproducing vascular resistance is most easily reproduced by inserting valves into
the peripheral circulation branch. For example, adjustable tube clamp, screw, ball or
gate type valves were used by Weber et al. (2002) and Wu et al. (2004). However,
this technique may be further enhanced by creating a valve dependant on the arterial
pressure, as observed by the baroreceptor response in the actual human system.
Donovan (1975) and Bearnson et al. (1996) reproduced this feedback response by
connecting an outflow occluding piece to a bellows in the arterial compliance
chambers. An increase in arterial pressure (from an increased flow into the chamber)
acts to displace the volume in the bellows, resulting in a mechanism removing the
plate occluding the flow path out of the chamber, thus reducing the resistance of the
flow path and therefore reducing the arterial pressure.
Alternatively, Mohara et al. (1998) reproduced peripheral resistance by correctly
selecting the inner diameter and length of tubing to produce the desired resistance.
For example, Tayama et al. (1997) used a length (270mm) of 6.5mm () ID tubing
in a loop of 9.5mm (3/8) ID tubing to recreate peripheral resistance equal to
100mmHg afterload. This technique replaces the resistance valve, thus reducing its
effect on blood damage. However, the ability to change resistance values is difficult.
Patel et al. (2003) identify the systemic peripheral vascular resistance of a healthy
patient as 0.85 PRU (1130 dyne.s.cm
-5
) at rest, while heart failure patients
3-30
experience a larger systemic resistance at 1.2-1.4 PRU (1596-1862 dyne.s.cm
-5
).
Pantalos et al. (2004) agreed that patients with heart failure encounter elevated
vascular resistance (2023 dyne.s.cm
-5
) from normal values (1218dyne.s.cm
-5
).
Compliance
Compliance of the aorta, pulmonary artery and consequent blood vessels is essential
for modelling the dynamic system for which a pump may be inserted. This enables
the system to incorporate and vary the effect of arterial elasticity and rigidity.
Donovan (1975), Bearnson et al. (1996), and Weber et al. (2002) each modelled
compliance by incorporating a closed (to atmosphere) outflow reservoir with
appropriate and variable fluid levels / air volume over the fluid. Pantalos et al.
(1998) also recommended the inclusion of a venous compliance chamber to replicate
venous compliance. The compliance chamber dimensions used by Patel (2003) were
two 1.5 (40mm) ID pipes at 16 (400mm) high, each containing a certain height of
water and air volume suitable for arterial and venous compliance. Values of
systemic arterial compliance employed by Pantalos et al. (2004) were 1.3 ml/mmHg
for both normal and failing heart mock loop simulation. Although they concede the
values were different to the clinical values of 1.4 and 0.3 ml/mmHg for normal and
heart failure respectively, they maintain both vascular input impedance, as well as
mechanical properties are the most critical parameters.
Cardiac Output
To simulate a failing heart, Endo et al. (2002) suggests cardiac output should vary
from 0.5 - 2.1 L/min. Both Patel et al. (2003) and Wu et al. (2004) recommend
values of 2 4.4 L/min for failing heart simulation, 5.2 L/min for normal heart
function and 7.95 L/min for exercise conditions. Pantalos et al. (2004) simulated 3
L/min for failing and 5 L/min for normal hearts at rest, while Golding and Smith
(1996) proposed that for normal heart simulation, cardiac outputs are expected
between 3.75-6.75 L/min at rest, and 5.6-10L/min under moderate activity.
Pressure Distribution
Patel et al. (2003) predict the resting mean aortic pressure (MAP) of normal patients
is 90-140mmHg, and slightly lower during heart failure. Wu et al. (2004) reaffirm
this observation in a study that attempted to reproduce five degrees of heart function.
A MAP of 102mmHg was identified as normal heart function, with congestive heart
3-31
failure simulated at 53mmHg. Additionally, a LVP
ED
of 3-12 mmHg is considered
normal, with values above this range expected in congestive heart failure patients.
The normal heart function in the study encountered a LVP
ED
of 9mmHg, with
18mmHg experienced in the same heart failure condition. The study by Pantalos et
al. (2004) demonstrated a normal MAP of 95mmHg while heart failure was
reproduced as 65mmHg. LVP
ED
was also recorded at 2-5mmHg and 15-35mmHg
for normal and heart failure simulations respectively.
Cardiac Assist Device Insertion
Chung et al. (2003) summarise the guidelines set by the National Institutes of Health
(NIH), which call for the preload on the left and right ventricles of a normal heart to
be 10mmHg, while afterload is 20mmHg on the right and 100mmHg on the left
ventricle. Furthermore Weber et al. (2002) maintains the inserted pump must be
capable of at least 8 L/min output.
To determine the effect of preload on the assist device, Endo et al. (2002) and
Weber et al. (2002) recommend the level of fluid (RAP and LAP) in the atrial tank
should be varied (-6 to 30mmHg) to simulate a change in venous return to the heart.
Tests may also be conducted with various right and left afterload.
Weber et al. (2002) further isolate the effect of afterload variation (vascular
resistance) by shunting both atrial reserves to keep the pressures at an identical level
of 13-15 mmHg. Each side must then be tested independently. The afterload should
be kept constant on the non-test side while the afterload on the tested side is varied
(Right =20-40mmHg, Left =60-170 mmHg).
Endo et al. (2002) suggest the sensitivity of the circuit to preload, afterload and
contractility variations induced by various stages of heart failure should be
investigated to determine the potential for ventricular sucking. Yuhki et al. (1999),
Olegario et al. (2003) and Wu et al. (2003) also agree the potential for the rotary
pump to collapse the ventricle should be investigated. If the simulated ventricle is
constructed from a suitably collapsible material (silicon balloon/latex rubber),
inserting the inflow cannula into directly into the ventricle will provide evidence of
sucking, given that the compliance of the ventricle material is similar to that of the
natural heart. Alternatively, Iijima et al. (1997) indicate a small collapsible tube
between the inflow to the pump and the ventricle will also reproduce this effect.
3-32
Pumping Mediums
Water is the most common pumping medium used in circulation loops. Water is the
most efficient medium to conduct tests, as it is cheap and readily available and the
density (1000 Kg/m
3
) is similar to that of the intended medium, blood (1053 Kg/m
3
).
Pantalos et al. (1998) and Yoshino et al. (2001) each used saline solutions (0.9%
NaCl) to closely match the aggressive, corrosive nature of the physiological
environment, while glycerol solutions at 37% (Kawahito, Takano et al. 2001;
Yoshizawa, Sato et al. 2002), 40% (Ayre, Vidakovic et al. 2000), 45% (3.5 cP)
(Gerhart, Horvath et al. 2002) or 52% (Chung, J oo Lee et al. 2003) have been stated
to replicate the viscosity of blood. Ayre et al. (2000) claim a Glycerine-water
analogue is the ideal solution to vary viscosity over a large range. Properties of the
mediums used in mock loops are given in Table 3-9.
Table 3-9 Properties of Pumping Mediums

Density
(Kg/m
3
)
Dynamic Viscosity
(mPas)
Water 998 1.0
Saline 1025 1.0
Haemaccel 3.5%
(0% hematocrit)
1050 1.2
Haemaccel
(39% hematocrit)
1050 3.9
Blood 1050 4
Glycerol (40%) 1103 3.9

The use of these solutions does not however provide evidence of pump performance
with regard to blood damage. Nonetheless, these mediums allow for any material to
be present in the pump. Therefore initial designs are tested with these solutions to
determine their basic performance.
Once a final design is manufactured from biocompatible materials, it is inserted into
a basic loop containing blood. To this end, Takami et al. (1997) and Yoshikawa et al.
(1999) circulated 400-450ml of animal (Bovine) or human blood. Tests of this
nature are governed by ASTM standard F1841-97, where the loop is initially filled
with a sterile saline solution and circulated for 30min then replaced with test blood
(ASTM_F1841-97 1998; Linneweber, Chow et al. 2001).
This standard specifies a basic mock circulation loop for the purpose of testing pump
hydraulic performance and blood damage level. The closed loop (Figure 3-19)
consists of two meters of 9.5mm ID PVC tubing, a 13cm x 13cm reservoir with
3-33
sampling port, a screw clamp for resistance, Ultrasonic or Magnetic Flow meters, a
Thermistor and 450ml +/- 45 ml primed blood volume. Pantalos (1998) recommend
the fluid temperature be maintained at 37
o
C +/- 3
o
C to correctly simulate
physiological conditions. Tayama (1997) achieve this by running a portion of the
tubing through a warm water bath.

Figure 3-19 ASTM F1841Test Loop (ASTM_F1841-97 1998).
Instrumentation
Mechanical assist devices inserted into the loop must be evaluated in terms of their
performance. Tansley (2000) explain this performance relates to flow rate, pressure
head development, efficiency (system and stage), with and without a pulsatile
environment. Gerhart (2002) advise pressure measurement locations should be
within six inches of the pump ports to eliminate effects of head friction losses.
Takami (1997) and Yoshino (2001) attained these measurements a simple U-tube
manometer, while Tansley (2000) used disposable and non-disposable pressure
transducers
3-34
Cardiac output is best monitored using non-fluid contacting probes. Yoshikawa et al.
(1999) and Yoshizawa et al. (2002) utilised magnetic probes Model 540, (Medtronic
Biomedicus, Inc., USA), while the more popular TRANSONIC ultrasonic flow
probes models are used by many centres (Takami, Yamane et al. 1997; Linneweber,
Chow et al. 2001; Weber, Doi et al. 2002; Chung, J oo Lee et al. 2003). These flow
probes provide the advantage of low flow resistance and non-contact measurement,
conventionally not available in paddle or optical flow probes.
3.3.4 In-Vivo Reproduction of Heart Failure
The importance of including variable left and right heart functionality in the mock
circulation loop is highlighted by the difficulties experienced in reproducing heart
failure in an in-vivo animal model.
Reitan et al. (2002) revealed that assessment of LVAD performance in-vivo is often
conducted in an animal with normal heart function. The results do not always
correlate to the evaluation of circulatory support in a heart failure model, and it is
therefore difficult to predict the hemodynamic contribution of the implanted device.
Consequently a number of techniques have been attempted to induce heart failure.
Myocardial Infarction is induced by ligation of coronary arteries; however the degree
of ventricular damage is unpredictable. Implementing pacemaker induced
tachycardia, coupled with inotropic drugs often leads to complete bi-ventricular
failure, rather than the desired left ventricular failure only. These procedures are
therefore not particularly suitable for LVAD assessment.
The group understood these difficulties and developed an adjustable left heart failure
model. Inotropic drugs were administered to induce bi-ventricular failure, and a
centrifugal pump was inserted to bypass and restore the function of the failed right
ventricle. The pump was set to output a continuous flow regardless of pulmonary
afterload. Therefore, left ventricular filling pressures / left atrial pressures were
increased from 5mmHg to 25mmHg, due to the backward congestion caused by the
failed left ventricle.
3-35
3.4 Simulation Model of Circulatory System
SIMULINK models based on underlying mathematical principles are an important
tool for evaluating a new design. By modelling a system, variables and parameters
can be easily altered to determine the magnitude of their effect on the overall system.
In terms of the mock circulation loop, it is possible to create a working model of the
system that incorporates variable vascular parameters for compliance and resistance,
together with heart functionality in the form of contractility and heart rate. This
enables greater insight into the construction and operation of an experimental test rig.
Therefore, parameter values were taken from the physical mock circulation rig to
assist design and provide a mechanism for validation.
This section details the development and operation of the complete cardiovascular
system model, before results are presented for simulated degrees of heart function
under specified physiological conditions.
3.4.1 Simulation Circulation System Configurations
The complete circulatory system loop was modelled with conditions of rest and heart
failure imposed. Individual components (heart, arteries, and veins) of both systemic
and pulmonary circuits were connected in series (Figure 3-20).
Complete Circulatory System
VENA
CAVA
BODY
RIGHT
HEART
PULMONARY
VEIN
PULMONARY
ARTERY
LUNGS
LEFT
HEART
AORTA
Anal ysi s
Figure 3-20 SIMULINK Model for Complete Circulation
3-36
30 31 32 33 34
6
8
10
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(b) Left Atri al Pressure
LAP
30 31 32 33 34
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(c) Left Ventri cul ar Pressure
LVP
30 31 32 33 34
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(d) Aorti c Pressure
AoP
MAP
30 30.2 30.4 30.6 30.8
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(a) Systemi c Pressure Di stri buti on
LAP
LVP
AoP
MAP
SVP

30 31 32 33 34
22
23
24
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
30 31 32 33 34
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVP
30 31 32 33 34
40
60
80
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
AoP
MAP
30 30.2 30.4 30.6 30.8
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP
SVP

(a) Systemic Pressure Distribution (a) Systemic Pressure Distribution
30 31 32 33 34
2
4
6
8
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(b) Ri ght Atri al Pressure
RAP
30 31 32 33 34
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(c) Ri ght Ventri cul ar Pressure
RVP
30 31 32 33 34
10
20
30
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(d) Pul monary Artery Pressure
PAP
MPAP
30 30.2 30.4 30.6 30.8
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(a) Pul monary Pressure Di stri buti on
RAP
RVP
PAP
MPAP
PVP

30 31 32 33 34
15
20
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
30 31 32 33 34
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RVP
30 31 32 33 34
30
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
PAP
MPAP
30 30.2 30.4 30.6 30.8
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(a) Pul monary Pressure Di stri buti on
RAP
RVP
PAP
MPAP
PVP

(b) Pulmonary Pressure Distribution (b) Pulmonary Pressure Distribution
Figure 3-21 Resting Pressure Distribution Figure 3-22 Left Heart Failure Pressure
Distribution
30 31 32 33 34
0
1000
2000
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(b) Left Ventri cul ar Fi l l i ng
LAQ
30 31 32 33 34
0
500
1000
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(c) Left Ventri cul ar Ej ecti on
LVQ
30 31 32 33 34
4
5
6
Time (sec) F
l
o
w

R
a
t
e

(
L
/
m
i
n
)
(d) Systemi c Capi l l ary Fl ow
SQ
MSQ
30 31 32 33 34
0
100
200
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(e) Systemi c Venous Return
SVQ
30 30.2 30.4 30.6 30.8
0
200
400
600
800
1000
1200
1400
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(a) Systemi c Fl ow Di stri buti on
LAQ
LVQ
SQ
MSQ
SVQ

30 31 32 33 34
0
500
1000
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(b) Left Ventri cul ar Fi l l i ng
LAQ
30 31 32 33 34
0
200
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(c) Left Ventri cul ar Ej ecti on
LVQ
30 31 32 33 34
2
3
4
Time (sec) F
l
o
w

R
a
t
e

(
L
/
m
i
n
)
(d) Systemi c Capi l l ary Fl ow
SQ
MSQ
30 31 32 33 34
0
100
200
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(e) Systemi c Venous Return
SVQ
30 30.2 30.4 30.6 30.8
0
200
400
600
800
1000
1200
1400
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(a) Systemi c Fl ow Di stri buti on
LAQ
LVQ
SQ
MSQ
SVQ

(a) Systemic Flow Distribution (a) Systemic Flow Distribution
30 31 32 33 34
0
500
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(b) Ri ght Ventri cul ar Fi l l i ng
RAQ
30 31 32 33 34
0
500
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(c) Ri ght Ventri cul ar Ej ecti on
RVQ
30 31 32 33 34
2
4
6
8
10
Time (sec) F
l
o
w

R
a
t
e

(
L
/
m
i
n
)
(d) Pul monary Capi l l ary Fl ow
PCQ
MPCQ
30 31 32 33 34
0
500
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(e) Pul monary Venous Return
PVQ
30 30.2 30.4 30.6 30.8
0
100
200
300
400
500
600
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(a) Pul monary Fl ow Di stri buti on
RAQ
RVQ
PAQ
MPPCQ
PVQ

30 31 32 33 34
0
500
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(b) Ri ght Ventri cul ar Fi l l i ng
RAQ
30 31 32 33 34
0
500
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(c) Ri ght Ventri cul ar Ej ecti on
RVQ
30 31 32 33 34
1
2
3
4
5
Time (sec) F
l
o
w

R
a
t
e

(
L
/
m
i
n
)
(d) Pul monary Capi l l ary Fl ow
PCQ
MPCQ
30 31 32 33 34
0
200
400
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(e) Pul monary Venous Return
PVQ
30 30.2 30.4 30.6 30.8
0
100
200
300
400
500
600
Time (sec)
F
l
o
w

R
a
t
e

(
m
L
/
s
e
c
)
(a) Pul monary Fl ow Di stri buti on
RAQ
RVQ
PAQ
MPPCQ
PVQ

(b) Pulmonary Flow Distribution (b) Pulmonary Flow Distribution
Figure 3-23 Resting Perfusion Figure 3-24 Left Heart Failure perfusion
3-37
A demo SIMULINK model PYSBE obtained from MATLAB was sourced and
extensively refined to mimic the configurations of the experimental circulation rig.
Refinements included:
Elimination of temperature variation effects
Reduction / combination of peripheral resistances into lumped resistances
Alteration of Ventricular contraction simulation
Addition of atrial subsystems
Modification of all component parameters to independently researched
clinical values and corresponding actual test rig values
Introduction of a variable mean circulatory pressure P
mc
.
A comprehensive description and breakdown of the SIMULINK model is provided
in Appendix D.
3.4.2 Results
Results were obtained for pressure and flow rate distribution throughout the
simulated complete circulation system under conditions of rest and heart failure.
The pressure distribution throughout the various components of the systemic
vascular tree reproduced by the complete SIMULINK circulation loop is shown in
(Figure 3-21). A mean aortic (MAP) pressure of 97mmHg and pulmonary arterial
(PAP) pressure of 17mmHg was simulated. Furthermore, LAP varied from 7-
10mmHg, while RAP oscillated about 3mmHg.
Simulated left heart failure encountered an expected decline in MAP to 59mmHg,
and rise in PAP to 30mmHg (Figure 3-22). LAP was also predictably higher
(23mmHg).
Systemic and pulmonic flow rates were recorded during simulated resting (Figure
3-23) and left heart failure (Figure 3-24) conditions. Perfusion was reduced from a
normal value (5.1 L/min) to those expected during LHF (2.67 L/min). Individual
component flow rates were also investigated over a full cardiac cycle. The
maximum ventricular ejection flow rate for simulated rest was 400 and 310 ml/sec
for left and right ventricles respectively. This was reduced to 200 and 190 ml/sec
when left heart failure was replicated.

3-38

Figure 3-25 Mock Circulation Rig

3-39
3.5 Experimental Mock Circulation Loop
Many current mock circulation systems concentrate solely on left ventricular assist
device evaluation, and may not incorporate pulsatile flow. This section describes the
development of a complete mock circulation loop, which incorporates pulsatile left
(systemic) and right (pulmonic) circulatory systems (Figure 3-25), designed to
function under the conditions of rest, exercise and heart failure. The equipment and
techniques used to reproduce design criteria of heart functionality, vasculature
performance, hemodynamic conditions and physiological conditions are detailed.
Experimental methods for measuring such performance characteristics are then
described in detail. Finally, the validity of the circulatory system with respect to
clinical hemodynamics is attained by presenting performance results during the
various simulated physiological conditions.
3.5.1 Design Criteria
To investigate the effect of Left- Right- and Bi- Ventricular assistance on the human
cardiovascular system, a systemic and pulmonary mock loop that adheres to the
Frank-Starling law is required. Additionally, the mock circulatory system should
have the ability to alter its hemodynamic characteristics to emulate varying degrees
of left and/or right heart function (normal, enhanced, failing) under several
physiological conditions (rest, exercise). Finally, there should be provision to easily
introduce any form of mechanical assistance.
3.5.2 Description of Mock Circulation Loop
Successful development of a circulation loop that closely simulates the native
cardiovascular system requires a comprehensive knowledge of cardiovascular
anatomy and hemodynamics. These anatomical features must be recreated in detail,
and techniques must be introduced to control hemodynamics and measure
performance.
This mock loop was developed to investigate the effect of Left- Right- and Bi-
Ventricular assistance on the human cardiovascular system. The rig follows the
Frank-Starling response to all physiological conditions by design, and features
reproducible and independently variable levels of left and/or right heart function.
Easily variable vascular parameters are included to dictate clinically expected
3-40
hemodynamic values. Most importantly however, systemic and pulmonary
circulation loops are connected in series. The circulation path and rig components are
detailed in Figure 3-26.

Figure 3-26 Top View Mock Circulation Loop with listed parameters
01 Left Ventricle 08 Tricuspid Valve 15 Left Atrium
02 Aortic Valve 09 Right Ventricle 16 Mitral Valve
03 Systemic Arterial
Compliance
10 Pulmonary Arterial Valve 17 Right Air Compressor
04 System Flow Meter 11 Pulmonic Arterial
Compliance
18 Left Air Compressor
05 Systemic Pinch Valve
Resistance
12 Pulmonary Flow Meter 19 Left Solenoid
06 Systemic Veins 13 Pulmonary Pinch Valve
Resistance
Vx Ball Valves
07 Right Atrium 14 Pulmonary Venous
Compliance

Circulation Rig Configurations
Although the mock loop was designed to simulate the complete cardiovascular
system, the ability to independently recreate systemic or pulmonary circuits was
introduced by the actuation of strategically placed ball valves. This extends the
ability of the loop to recreate previously designed mock circulatory systems that
concentrate solely on left or right assistance. In this configuration, the system can
also function as a basic mock loop, thus allowing the evaluation of non-pulsatile
performance characteristics.
08
10
11
14
12
13
07
V5
V6
V7
V8
03
06
V3
04
05
02
01
16
15
V1
19
18
17
V4
V2
09
3-41
Table 3-10 details the valve actuation status to reproduce the simulated left, right or
total system.
Table 3-10 Valve Settings for Various Circulation Configurations
Total System Left Only Right Only
Valve 1 ON OFF OFF
Valve 2 ON OFF OFF
Valve 3 OFF ON N/A
Valve 4 OFF N/A ON
Cardiac
Structural
The left and right hearts consist of passive atrial and pneumatically actuated
ventricular chambers divided by check valves. The ventricles are further isolated
from the arterial vasculature by another check valve (Figure 3-27).

Figure 3-27 Structural components of the simulated beating heart
Atrial Chambers
These chambers are open to atmosphere and constructed from 40mm clear flexible
PVC piping to provide sufficient compliance (change in volume / change in water
height) and allow fluid level viewing. In short, an extra water volume corresponds to
a water level rise, which corresponds to a pressure head. Therefore the compliance is
the volume change (mL) / the change in pressure head (mmHg). A transducer is
fitted to a port at the base of the chamber to provide the atrial pressure measurement
as a head of water. A sufficient atrial pressure must be maintained to provide a
sufficient pressure gradient during the ventricular refilling phase.
3-42
Mitral / Tricuspid Valves
One way swing check valves are inserted between the atrial chamber and the
following ventricle chambers. The resistance to flow of these valves must be low
enough so as to allow unimpeded and rapid flow from atrium to ventricle (required
by phase 4a rapid ventricular filling of the cardiac cycle). Although average native
valves are approx 23mm in diameter, 40mm brass check valves were used since the
swing component has a resistive weight and obstructs some of this area.
Ventricular Chambers
The ventricular chambers are similar in construction to the atrial chambers; however
they are sealed and tapped with a 6.5mm hose-tail enabling compressed air to be
input during systole and vented during diastole. A pressure transducer is fitted
together with a small compliance chamber (syringe) to reduce the effects of water
hammer experienced by the check valves.
Aortic / Pulmonic Valves
Brass swing check valves were placed after each ventricle to prevent backflow from
the arterial line during the isovolumetric relaxation (diastolic) phase.
Functional
The components employed for the reproduction of heart function are displayed in
Figure 3-28.
Regulator
Pressure Gauge
3/2
Solenoid

Figure 3-28 Control and monitor of cardiac function

3-43
Heart Contraction
The simulated heart must be able to pump a volume of fluid at a certain pressure for
each contraction. These pressures are reproduced by regulating (Model 11-818-100,
Norgren) compressed air and introducing it into the top of the left and right
ventricular chambers during the systolic phase. Venting the air during the diastolic
phase allows refilling of the ventricle, with the resulting water level in the chamber
representing the end diastolic volume and pre-load (head of water). Thus ventricular
pressures rise to systolic levels, before falling to zero gauge pressure at the onset of
diastole. Left and right end diastolic pressure depends on left and right atrial
pressure. However, this final value may also be influenced by the solenoid vent area.
Contractility
The contractility (rate of pressure rise) is controlled by the mass flow rate of air into
the chamber, as this determines stroke volume for each contraction. This may be
varied by restricting the flow of air out of the compressor and into the regulator (in
the form of another regulator to reduce the air pressure leaving the compressor), thus
restricting the air flow into, but not out of, the ventricular chambers. Relaxation
(rate of pressure drop) is also important and relates to the ability for air contained in
the ventricular chamber to escape. This can be varied by using a valve to change the
effective area of the solenoid exit port.
Heart Rate and Systolic Time
The rate of contractions must be variable and controllable. This is achieved by
utilising a 3/2 solenoid valve for each ventricle. Signalling the solenoid ON allows
the compressed air into the chamber simulating the systolic phase, while signalling
the solenoid OFF vents the air within the ventricle during diastole. The switching
rate determines the heart rate while the percentage time ON and OFF during each
cycle influences the systolic and diastolic times, and consequently the volume of air
input into the ventricle. The solenoid effective area when open and venting must be
sufficient to allow suitable air flow into and out of the ventricle, thus an SMC-317,
3/2 Solenoid with an effective area of 26mm
2
was used.
3-44
Vasculature
Compliance
A simple loop from left ventricle to right atrium and right ventricle to left atrium
would serve the function of systemic and pulmonic arteries and veins respectively.
However, the stiffness and rigidity of the 25mm poly piping used does not compare
to the elastic nature of blood vessels, and physiological pressures of 120/80 mmHg
would not be observed. Therefore, to reproduce the compliant nature of such vessels,
arterial and venous chambers are plumbed into the circuit. Each chamber is closed to
atmosphere, and contains a certain volume of air above the water level. This volume
of air controls the change in chamber pressure with the introduction of an extra
volume of water into the chamber (compliance). Equation [3-17] characterises the
change in pressure of a vessel due to the introduction of an additional amount of air
to the initial air volume. The process is assumed isothermal for simplicity.
This can be rearranged to solve V
1
by substituting for V
2
(Equation [ 3-18 ]).
Since the arteries and veins of the systemic and pulmonic systems have different
pressure changes for given stoke volume (i.e. compliance values), chambers of
appropriate dimensions were used recreate the desired compliances (Table 3-11).
The initial compliance was reduced during operation since fluid is shifted to create
the diastolic value of pressure, therefore increasing the density and thus reducing the
physical volume of air within the chambers. Compliance values within the chambers
can alter with differing physiological conditions, therefore arterial and venous
chambers were capped with movable 100mm and 150mm test plugs respectively
(Figure 3-29). These test plugs had a thickness of 40mm and could be easily moved
up and down the pipe to change the initial volume of air (IV
air
) contained above the
water and thus effectively alter compliance.
2 2 1 1
V P V P =

[3-17]
P
1
=Diastolic Pressure (P
dias
)
V
1
=Initial volume of air above the fluid (IV
air
)
P
2
=Systolic Pressure (P
sys
)
V
2
=Volume of air above the fluid after systole (IV
air
SV)

1
1 2
1
) (
P
SV V P
V

=

[ 3-18 ]
3-45
Table 3-11 Chamber characteristics for Resting Compliance Values

Table 3-12 Mock Circulation Rig Component Inherent Resistance Values

Systemic
Arterial
Pulmonic
Arterial
Systemic
Venous
Pulmonic
Venous
Volume Change (mL) 56 56 10 10
P
dias
(mmHg) 80 10 10 9
P
sys
(mmHg) 120 25 10.2 12
Tank Dimensions (mm) 100 x 350 100 x 500 150 x 1000 100 x 1000
Height test plug above fluid (mm) 230 300 920 720
Initial Volume of Air (mL) 1,805 2355 17,622 5,652
Diastolic Air Volume (mL) 1,621 2325 17,490 5,588
Target Compliance (mL/ mmHg) 1-2 2-3 20-50 4-6
Initial Compliance 2.3 3 23.25 7.4
Operational Compliance 1.85 2.94 23 7.1
Components
Rest
(PRU)
LHF
(PRU)
Exercise
(PRU)
Tricuspid Valve 0.004 0.004 0.004
Pulmonary Artery Valve 0.0156 0.0156 0.0156
Pulmonary Capillaries 0.061 Inf 0.061 Inf 0.061 Inf
Pulmonary Veins 0.0041 0.0041 0.0041
Mitral Valve 0.0049 0.0049 0.0049
Aortic Valve 0.0277 0.0277 0.0277
Systemic Capillaries 0.256 Inf 0.256 Inf 0.256 Inf
Systemic Veins 0.008 0.008 0.008

Figure 3-29 Compliance Chamber Figure 3-30 Proportional Pinch Valve
3-46
Resistances
The mock loop must account for the peripheral vascular resistances of the systemic
and pulmonary circulatory systems. Each arterial, capillary and venous resistance
was lumped into individual systemic (SVR) and pulmonic (PVR) vascular resistance
values respectively.
Initial SVR and PVR were experienced by the inherent area resistance of the 25mm
poly piping, check valves and fittings. This was further refined by proportional
control pinch valves (ECPV-375B, HASS Manufacturing, USA) located between the
arterial and venous chambers on their respective circulatory sides (Figure 3-30).
The valves pinch 9.5mm (3/8) ID tubing in proportion to a 1-5 V input signal, thus
allowing the overall resistances to be finely adjusted between 700 - 1500 dyne.s.cm
-5

and 77-250 dyne.s.cm
-5
for systemic and pulmonary loops respectively.
Inherent resistance values were calculated by taking the required pressure drop
across a component and dividing it by the maximum flow rate through the
component (Equation [ 3-8 ]). To reiterate, maximum flow rate is calculated by first
using Bernoullis equation (Equation [ 3-9 ]) to determine maximum fluid velocity
(v
2
), assuming initial and final water heights are equal (z
1
=z
2
) and initial velocity (v
1
)
is zero. Multiplying final velocity (v
2
) by each components maximum pipe cross
sectional area (A) reveals maximum flow rate Equation [ 3-10 ].
Using this method, the minimum inherent resistance of the tubing due to the internal
cross sectional area was calculated at 323 dyne.s.cm
-5
(0.256 PRU) for systemic, and
77 dyne.s.cm
-5
(0.061 PRU) for pulmonary loops. Values calculated for each rig
component are displayed in Table 3-12. Further reductions in flow rate and therefore
increase in resistance would occur as a result of frictional resistance to flow, however
these losses are assumed to be negligible as flow is laminar, viscosity is low and pipe
section length is small.
The use of pinch valves proportionally controlled by a voltage input signal allows,
with a suitable control algorithm, the resistance to be varied in response to changes in
arterial pressure, as regulated by the baroreceptors of the natural system. This was
not incorporated in this study, and therefore forms a task for future implementation.

3-47
Hemodynamic Performance
Pressures
Exact physiological pressures must be reproduced within each simulated chamber
and blood vessel.
Table 3-2 describes the desired distribution of pressures throughout the circulatory
system for conditions of rest. Pressures were attained by the actuating ventricle and
ranges maintained by the appropriate compliance and resistances. Values of Venous
and Atrial pressure will be slightly higher for conditions of heart failure.
Mean circulatory pressure (P
mc
) was achieved by pressurising the system to the
required level (Table 3-3) by adding a volume of fluid to the open atrium prior to
commencement of the heart beat.
Pressures were monitored and recorded via two methods. Firstly, qualitative
measurements were made with Edwards Life Sciences (NPC-100, GE, USA)
disposable pressure transducers coupled to a patient monitor (Series 7010, Marquette
Electronics, USA). Quantitative results were obtained using TOYODA (SD10B-1,
Gambro, USA) pressure transducers supplied with a 12V source returning a
calibrated voltage signal.
Flow Rates
Physiological perfusion rates must be simulated in the mock circulation loop
circulation. Three flow rates, determined from clinical setting and literature, are
targeted for reproduction (Table 3-13). Systemic and pulmonary flow rates were
independently monitored with two electromagnetic flow meters (IFC010, KROHNE,
Netherlands) (Figure 3-31).

3-48

Figure 3-31 Electromagnetic Flowmeter
Table 3-13 Physiological flow conditions
Rest Exercise Heart Failure
Flow Rate 5 L/min 9 L/min 2-3 L/min

Simulated Physiological Conditions
The physiological conditions of Rest, Exercise and Heart failure are reproduced by
changing the mean circulatory pressure (P
mc
), altering heart contractility (by
regulating the air pressure from the compressor), resistances (by changing the pinch
valve restriction), and arterial compliance (moving test plugs within chambers). The
aim was to reproduce clinical hemodynamic response to each condition.
Rest
Setting the vascular parameters (P
mc
, compliance, resistance) as well as heart
function (Contractility and heart rate) to values for rest determined previously,
cardiac output and pressure distribution was attained for the resting condition.
Exercise
An exercising body is characterised by an increased perfusion rate as a result of
increased P
mc
, reduced vascular resistance, increased MAP, and enhanced heart
function (rate and contractility). Furthermore, ventricular filling during diastole also
relies heavily on atrial contractions. Unfortunately, not all changes required for
exercise could be reproduced in the complete system.
3-49
For example, although SVR could be sufficiently lowered, minimum inherent
resistance of the pulmonary system was larger than that required of PVR for
exercise. Therefore, the exercise condition could only be represented in the systemic
loop configuration only. This concession influenced either diastolic ventricular
filling or perfusion rates. The former condition arises if the value of LAP is lowered
to RAP. Alternatively, the LAP could be maintained at the expense of reduced
systemic pressure gradient and thus the later condition is evident. Therefore a
compromise pressure was identified.
Another drawback of the current loop involves the absence of atrial kick
reproduction. However, it is entirely possible to reproduce this natural atrial function
by scaling down the technique for ventricular contractility. The atrial chambers can
be capped and compressed air (regulated to lower pressure) introduced for a period
during the diastolic cardiac phase.
Heart function was successfully replicated for exercise conditions. Heart rate was
increased by altering the switching rate of the solenoid valve, and SVR was
sufficiently reduced by increasing the aperture in the pinch valves to allow the
increased perfusion. Contractility was enhanced by increasing the value of regulated
ventricular chamber input pressure.
Heart Failure
Correct heart failure simulation depends on the degree of failure, as well as the level
of medical therapy treatment. For example, in untreated heart failure, increasing
SVR is the natural autoregulatory response to maintain MAP at the expense of
perfusion rate. However, heart failure medical treatment reduces SVR to improve
perfusion, resulting in lower MAP values.
Varying degrees of Left Heart Failure, Right Heart Failure and Bi-Ventricular Heart
Failure are possible by reducing the contractility (i.e. mass air flow rate) of one or
both of the individual ventricles, increasing P
mc
(by adding more fluid volume),
reducing chamber compliances (by lowering test plugs), and adjusting peripheral
vascular resistance (by actuating the pinch valves).

3-50

Figure 3-32 Experimental Technique
3-51
Experimental Technique
CONTROLDESK was used as an interface to a SIMULINK model that
communicated with the rig via a dSPACE card. This enabled the capture of
hemodynamic variables (such as flow and pressure) and real time control of some
vascular and heart parameters (vascular resistance, heart rate/systolic period) (Figure
3-32).
Control Software
MATLAB and SIMULINK (Mathworks) software packages were used to develop
the control model for circulation rig and mechanical assist device operation. The
complete model is extensively reviewed in Appendix D. The model allowed for the
real time control of the solenoid valves (Heart rate and Systolic period), proportional
control valves (vascular resistance), and assist device motor speed, using the
CONTROLDESK interface.
DSP Board
Digital signal processing was accomplished using a dSPACE PCI signal processing
board (DS1104, MI, U.S.A). This model accommodates 8 D/A (2 x Pinch Valve), 8
A/D (6 x Pressure, 2 x Flow) signals, 2 encoder inputs (1 x assist device motor
speed) and 2 digital I/O ports (2 x Solenoid Valve).
Instrumentation
The instrumentation used to measure rig component performance retuned voltage
signals in proportion to each measured value. These signals were displayed and
captured in real time with CONTROLDESK.
3-52
3.5.3 Experimental Procedure
A description of the experimental procedure for mock loop evaluation follows.
Parameter values are referenced in Table 3-14.
Table 3-14 Mock Circulation Loop Parameter
Rest LHF Exercise
Left Right Left Right Left
Heart Functionality
Heart Rate (bpm) 60 60 60 60 120
% Time in Systole 40 % 40 % 40 % 40 % 50 %
Compressor Reg P
out
(bar) 1.9 7.5 0.25 7 6.5-8
Regulator P
in
(mmHg) 117 88 108 62 197
Resistance
Pinch Valve Signal (Volt) 1.47 4 1.38 2 1.71
Vascular Resistance (PRU) 1.08 0.1 0.95 0.22 0.63
Vascular Resist. (dyne.s.cm
-5
) 1439 133 1266 293 839
Added Water Volume (mL) 400 400 1100 1100 1100
P
mc
(mmHg) 7 7 20 20 20
Compliance
Distance of Test Plug from
arterial chamber top
40mm 120mm 150mm 120mm 230mm
Arterial Compliance 1.85 2.94 1.2 2.95 0.4
Distance of Test Plug from
venous chamber top
1000mm 800mm 500mm 800mm 500mm
Venous Compliance 23 7.1 11.5 7.1 4.2

Rig Configuration: The mock circulation rig was configured to operate in the
complete circulation mode to evaluate hemodynamic performance for resting and
heart failure conditions. This was achieved by opening ball valves 1 and 2, while
closing valves 3 and 4. Due to the rig limitations discussed, the exercise condition
could only be reproduced in the systemic loop. This required the closure of valves 1,
2 and 4, and opening valve 3.
Setting Compliance: Compliance values were established by positioning the test
plugs at a vertical distance from the top of each chamber. Small piping holes
through the test plugs were capped by the pressure transducers and a bleed valve.
This valve was opened to equalise chamber pressure with atmospheric.
Fluid Filling: The rig was then filled with approximately five litres of room
temperature (20
o
C) water. This volume filled the piping and raised the water level to
40mm above the bottom of each compliance chamber. At this point, the bleed valves
were closed, trapping a predetermined volume of air above each water level.
3-53
Setting P
mc
: An additional volume of water was then added to the left and right atrial
chambers. Due to the compliance of all chambers, this volume slightly compressed
the air in each chamber. Water was added until the desired the mean circulatory
pressure was reached.
Heart Functionality: Left and right air compressors were charged to 7 Bar. The
output regulator of the left compressor was changed to reflect the degree of left heart
functionality for simulation. Left and right input regulators were also tuned to reflect
the heart condition. At this point, heartbeat was commenced. The CONTROLDESK
interface enabled the selection of heart rate and systolic period, which was
transferred to the solenoid valves.
Vascular Resistance: Vascular resistance was then tuned to reproduce the desired
hemodynamic response. Values of resistance are presented as voltage signals
between 1-5V, one representing closed and five, fully open.
3-54

0 1 2 3 4
16
18
20
22
24
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
0 1 2 3 4
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVP
0 1 2 3 4
50
60
70
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
AoP
MAP
2.4 2.6 2.8 3 3.2 3.4
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP

0 1 2 3 4
2
4
6
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
0 1 2 3 4
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RVP
0 1 2 3 4
10
20
30
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
PAP
MPAP
0.8 1 1.2 1.4 1.6 1.8
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
(a) Pul moni c Pressure Di stri buti on
RAP
RVP
PAP
MPAP
1 2 3 4
0
20
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
0 1 2 3 4
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RVP
0 1 2 3 4
20
30
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
PAP
MPAP
2.4 2.6 2.8 3 3.2 3.4
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
RVP
PAP
MPAP


Figure 3-33 Pressure distribution
throughout the vascular tree for systemic (a)
and pulmonic (b) circulation` systems for
resting conditions
Figure 3-34 Pressure distribution
throughout the vascular tree for systemic (a)
and pulmonic (b) circulation systems for
heart failure conditions.
0 0.5 1 1.5 2 2.5 3 3.5 4
0
1
2
3
4
5
6
Time (sec)
P
e
r
f
u
s
i
o
n

R
a
t
e

(
L
/
m
i
n
)
MSQ
SQ
MPQ
PQ

0 0.5 1 1.5 2 2.5 3 3.5 4
0
1
2
3
4
5
6
Time (sec)
P
e
r
f
u
s
i
o
n

R
a
t
e

(
L
/
m
i
n
)
MSQ
SQ
MPQ
PQ

Figure 3-35 Perfusion Rate for Rest Figure 3-36 Perfusion Rate for Left Heart
Failure.
0 1 2 3 4
8
10
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
0 1 2 3 4
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVP
0 1 2 3 4
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
AoP
MAP
0.8 1 1.2 1.4 1.6 1.8
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP
3-55
3.5.4 Results
Results were obtained to verify the ability of the mock loop to recreate the
hemodynamic characteristics of the natural circulatory system. Complete mock loop
results for rest and left heart failure conditions are presented for comparison, before
those obtained for exercise from the systemic loop configuration are displayed.
For each result of pressure distribution, all component pressures over a single cardiac
cycle are compared in the left graph. The three graphs on the right side detail the
individual component pressure over four seconds. Systemic and Pulmonary perfusion
rates are also displayed over four seconds.
Rest and Left Heart Failure Simulation
Pressures recorded in the systemic and pulmonic loops for resting conditions are
displayed in (Figure 3-33). A mean aortic (MAP) pressure of 96mmHg and
pulmonary arterial (PAP) pressure of 17mmHg was observed. Furthermore, LAP
varied from 8-10mmHg, while RAP oscillated about 4mmHg.
The left heart failure condition encountered an expected decline in MAP to
60mmHg, and rise in PAP to 30mmHg (Figure 3-34). LAP was also predictably
higher (20mmHg), indicating a degree of pulmonary congestion. Considerable
pressure spiking and ringing was observed in the artificial atrial and ventricular
chambers. These occurrences were attributed to water hammer surges caused by the
rigidly mounted and rapidly closing brass swing check valves. These relatively high
frequency fluctuations were digitally filtered in real-time. Furthermore, a phase
difference was observed between ventricular and arterial pressure measurements.
This was attributed to the inherent inertial effects of the mock vasculature, due to the
piping cross-sectional areas and lengths, coupled with the vascular chamber
dimensions. Additionally, the physical distance from ventricle to arterial chamber
contributed to the phase delay due to the pressure wave speed.
Systemic and pulmonic perfusion was monitored during simulated resting (Figure
3-35) and left heart failure (Figure 3-36) conditions. Perfusion was reduced from a
normal value (5.15 L/min) to those expected during LHF (2.7 L/min).

3-56
Exercise Simulation
The simulated exercise condition in the systemic loop configuration produced the
pressure distribution displayed in (Figure 3-37). An elevated MAP of 122mmHg
was observed, with systolic pressure (P
sys
) exceeding 180mmHg while diastolic
pressure (P
dias
) was maintained at 80mmHg. Left atrial pressure was 20-18mmHg
during the ventricular filling phase, indicating a larger mean circulatory pressure. An
increase in heart rate is also observed by the reduced period of cardiac cycle.
Figure 3-38 displays the perfusion rate (9.5 L/min) observed over eight cardiac
cycles, during simulated exercise conditions.

These results presented for rest, LHF and exercise show close correlation to the
native hemodynamics. Furthermore, systemic and pulmonary flows were closely
matched in each condition, indicating the system adheres to the Frank-Starling law of
the heart.
Frank-Starling Response
The rig's adherence to Frank-Starling Law is by design, and although not
quantitatively measured was qualitatively observable during operation. Changes in
preload were observed through the clear PVC piping as changes in ventricular
chamber fluid level prior to systole. A consequent change in stroke volume was also
observed through these chamber walls. Quantitative measurement of this
phenomenon is identified as future work.

0 1 2 3 4
0
50
Time (sec)
P

(
m
m
H
g
)
LAP
0 1 2 3 4
0
100
200
Time (sec)
P

(
m
m
H
g
)
LVP
0 1 2 3 4
80
100
120
140
160
180
Time (sec)
P

(
m
m
H
g
)
AoP
MAP
0 1 2 3 4
32
34
36
Time (sec)
P

(
m
m
H
g
)
(e) Systemi c Venous Pressure
SVP
1.8 2 2.2 2.4
0
20
40
60
80
100
120
140
160
180
200
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP
SVP

0 0.5 1 1.5 2 2.5 3 3.5 4
0
1
2
3
4
5
6
7
8
9
10
Time (sec)
P
e
r
f
u
s
i
o
n

R
a
t
e

(
L
/
m
i
n
)
Systemi c Perfusi on Rate
MSQ
SQ

Figure 3-37 Systemic Pressure Distribution
(Exercise)
Figure 3-38 - Perfusion Rate for systemic
circulation (Exercise)
3-57
3.6 Discussion
For effective simulation of the cardiovascular system, native heart functionality,
vasculature, pressure, perfusion and autoregulation must be replicated for all
physiological conditions. The following discussion focuses on the techniques used
and results obtained from the simulation model and physical mock circulation loop.
3.6.1 Heart Functionality
Heart functionality relates to heart rate, systolic and diastolic periods, maximum
ventricular pressure, contractility and relaxation, adherence to the Frank-Starling
Law and backflow prevention.
Heart rate, Systolic/Diastolic Periods, Max Ventricular Pressure
Comparison of ventricular performance, from the native to simulated circulation and
mock circulation, revealed similar ventricular pressure pulse wave development for
each heart function condition. Maximum ventricular pressures, pulse widths (40%
systole) and heart rates (60-120bpm) dictated by native values were replicated in the
simulated model (Appendix D) and mock loop (Table 3-14).
The pneumatic technique of introducing compressed air into the ventricle chambers
to recreate the hearts function was successful in producing pulsatile flow in the
mock circulation loop. The 3/2 solenoid valves enabled the successful variation of
heart rate (ON/OFF rate) and systolic period (ON period), while the regulators at
ventricular entrance limited ventricular maximum pressure (pulse amplitude).
Contractility and Relaxation
The native ventricle encounters a decreasing compliance during the systolic phase.
The pneumatic technique of heart functionality reproduced this characteristic by
introducing air into an initial, pre-systolic ventricular chamber air volume above the
fluid level. According to Boyles law, the additional air pressure increase within the
ventricle was in proportion to the rate of air inflow. The ability to easily vary the
degree of heart function (contractility) to simulate all physiological conditions, by
simply varying input air mass flow rate was provided. This was achieved by
regulating the exit pressure from the compressors. The regulators at the ventricular
entrance were unaffected and continued to limit the maximum pressure in each
chamber. The use of a large effective area solenoid valve (26mm
2
) allowed for
3-58
sufficient mass flow rate into and out of the ventricle. This latter situation is
responsible for ventricular relaxation, and could be altered by placing a restriction
valve on the solenoid exhaust port. The compliance of the ventricle was sufficiently
low, and in combination with inflow air resistance, provided a sufficient rise time
(contractility) response to achieve and maintain maximum ventricular pressure.
The pressure development rise time differed in simulation model. This variation in
contractility is attributed to the difference in system order of the simulated model and
physical mock loop systems. The simulation model was confined to a first order
system, characterised by no overshoot in response to a step ventricular pressure
input. The mock loop however, featured a considerable amount of overshoot and
relatively long settling time. Inertiance of the compressed air and circulating fluid
elevates the mock loop to second order. For example, the water hammer effect of the
rapidly closing, and rigidly mounted check valves caused significant pressure spikes
within the ventricle. These spikes are dampened in the native cardiovascular system
due to the compliant nature of the valves, ventricular walls and vessels. The high
frequency pressure spikes were reduced in the mock loop by the use of a small
compliance chamber and digital low pass filter.
Frank-Starling Law
The natural heart has the ability to alter contractility in response to changes in
preload. This preload is determined by venous return passively filling the ventricle
during the diastolic phase. Passive filling ventricles are an important feature, since
the natural heart is predominantly non-sucking, and relies on atrial and venous
pressures to refill the ventricle during diastole. An increase in preload, due to
increases in alternate ventricular function or mean circulatory pressure, stretches the
ventricular myocytes thus enabling a more forceful systolic contraction. This is the
guiding principle behind the Frank-Starling Law, and was qualitatively observed in
the mock loop. An increase in ventricular preload resulted in an observably higher
fluid level within the clear walled ventricular chamber. This effectively reduced the
volume of air contained within the chamber above the fluid prior to the subsequent
systolic period. An increase in contractility resulted, since the time for pressure rise
in the smaller air volume for the same input mass flow rate is lower, and therefore
stroke volume was observed to increase. This effect is reversed for cases of reduced
preload, for which the current system has an operational limitation.
3-59
There is currently no physical barrier to prevent continued ventricular ejection in
cases of very low venous return / preload. Although the system can be tuned for this
not to occur, if preceding vascular resistance increases and thus venous return
reduces to one ventricle, continued ejection will be attempted, forcing air into the
system. A suggested future method to counteract this limitation employs a light
weight ball floating in the ventricular chamber. The ball diameter would be
sufficiently large to plug the base of the ventricle pipe during cases of low preload,
thus preventing ejection. An adequate clearance with the ventricular chamber pipe is
also required to allow vertical movement.
Backflow Prevention
The brass check valves performed the function of the various heart valves by
providing low resistance to forward flow as well as successful restriction of back
flow. However, pressure fluctuations were encountered in the mock loop ventricles
and atria immediately following respective check valve closure. These fluctuations
are not found in the simulation model, since it is a first order system and no backflow
is possible.
The fluctuations were attributed to water hammer effects caused by the sudden and
forceful closure of the valve. This effect was amplified by the weight of the swing,
its metallic nature, and hence inherent non-compliance. Additionally, a small amount
of leakage would contribute to the atrial pressure fluctuations, as the swing bounces
upon closure. In the natural heart, this pressure transferral is apparent (although not
caused by fluid transferral) as the valves are compliant and bulge into to the
neighbouring chamber when closed.
An attempt was made to dampen the ventricular pressure oscillations via two
techniques. Firstly, a digital low pass filter was placed on the ventricular pressure
recordings and secondly, a small compliance chamber (syringe filled with air) was
inserted near to the closing valves. Refinement of this latter technique by altering
syringe size (compliance) and input resistance has the potential to further eliminate
the effect. In order to reduce backflow and thus atrial fluctuation, each valve could
be replaced by plastic check valves, or ultimately mechanical type artificial heart
valves. Mounting these valves on a compliance rubber base would help alleviate the
encountered problems.
3-60
3.6.2 Pressure Distribution
Blood pressure distribution within the heart chambers and vascular network was
recreated for all physiological conditions in the simulated model and mock
circulation loop. Pressures recorded in the mock loop are compared to the native,
literature and simulated model cardiovascular pressure distribution in Table 3-15.
Table 3-15 Comparison of Mock Circulation Loop Pressure Results
mmHg
L
A
P

L
V
P

L
V
P

E
D

A
o
P

M
A
P

R
A
P

R
V
P

R
V
P

E
D

P
A
P

M
P
A
P

P
m
c

REST
Natural
8 -
10
0 -
120
8
120
/80
93 3
0 -
25
3
25
/10
15 7
(Pantalos, 2004) 10.5
-9 -
139
2 - 5
125
/68
95 - - - - - -
(Patel, 2003) - - 9
140
/90
102 - - - - - -
Mock Loop 8-10
0 -
120
5
119
/78
96 4
0 -
32
4
26
/11
17 7
Simulation 7-10
0 -
120
7
113
/79
97 3
0 -
36
3
27
/11
17 7
LHF
(Pantalos, 2004) 16.3
-1 -
93
14
84
/43
60 - - - - - -
(Patel, 2003) -
-3 -
65
18
60
/40
53 - - - - - -
Mock Loop 20
15 -
80
20
70
/50
60 16
17 -
40
17
35
/25
30 20
Simulation 22
22-
80
23
72
/49
59.5 16
14 -
40
16
36
/25
29.5 20
EXERCISE
Mock Loop
17 -
55
0-
185
10
185
/78
121 - - - - - 22

Ventricular Pressure
Ignoring the effects of water hammer, the use of inflow regulators successfully
restricted left ventricular pressure in the simulation model and physical system to a
maximum ventricular pressure for each physiological condition.
Arterial Pressure
These pneumatically generated ventricular pressures were successfully transferred to
the arterial chambers in the physical mock circulation system. This transferral
experienced a phase delay not encountered in the simulation model or native
cardiovascular function. This delay may be attributed to a combination of the
inherent mock vascular inertiance (caused by changing pipe directions and cross-
3-61
sectional areas) which, together with arterial chamber compliance and input
resistance (check valve), influenced the time response to a step input. Further
contributions to this effect could be credited to pressure wave reflections and speed,
and the physical location of the arterial chamber.
Despite the lag, pulse pressures and mean arterial pressures were maintained, due to
the use of correct chamber compliances and exit vascular resistances. In the physical
mock loop, pulse pressure was increased from 20mmHg (LHF) to 41mHg (rest) and
107mHg (exercise). Corresponding increases in MAP from 60mmHg (LHF) to
96mmHg (Rest) and finally 121mHg (Exercise) matched those expected in each
simulated model condition.
The arterial pressure wave in the simulation model (Figure 3-21) develops as a
characteristic response to a step ventricular pressure input, while it reduces in a
fashion dictated by a single value of vascular resistance. The mock loop however
(Figure 3-33), has a distinctive rising pressure development slope, culminating in a
peak pressure before diminishing with a reducing pressure slope. Native arterial
pressure waves are also characterised by varying slopes of pressure increase and
decrease, attributed to the elastic nature and thus slight area (inherent resistance)
changing response to the pressure pulse.
Slight differences in pressure pulse developments for all vascular components,
between simulation model and mock loop results, can be attributed to the difference
in system order. The simulation was modelled as a first order system, incorporating
values of compliance and resistance in an equivalent RC circuit. However, the actual
circulation rig encounters a level of fluid inertiance (inductance) and therefore
replicates a second order RLC circuit. Additionally, but less significantly, the single
and unchanging value of inherent vascular resistance employed in the simulation
model differs from the resistance characteristic of the mock loop. The vascular flow
area of the loop does not change during each pressure pulse. However, the value of
pressure differential changes during this pulse, therefore the value of maximum flow
velocity and consequently inherent resistance value changes to a small degree.
Atrial Pressure
During diastole, ventricular preload is observed as ventricular pressure increases to
the value of atrial pressure. The Left atrial pressure in the mock loop was maintained
3-62
between 8 and 10 mmHg, for normal heart resting conditions. The atrium of the
failed left heart experienced elevated pressures (20mmHg), predominantly due to the
reduction in left heart function and increase in P
mc
.
Left atrial pressure is difficult to maintain in a systemic only circulation loop that
relies on passive filling ventricles. The native RAP is lower than LAP, and since
these components are merged in the systemic only loop, either the RAP is too high or
LAP is low. The former situation requires a lower SVR than normal to provide
sufficient perfusion, since the arterial/venous pressure gradient is lower. The latter
case reduces the operation of the heart, since the atrial/ventricular pressure gradient
is lower, and ventricular filling is impaired. This may be overcome by considerably
reducing the atrial/ventricular valve resistance, or incorporating a sucking type
ventricle to create a negative pressure in the ventricular chamber to induce flow. The
mean circulatory pressure also compounds the problem, since the commencement of
the heart beat shifts fluid from the venous to arterial chambers. Therefore, the venous
pressure falls in proportion to the rise in arterial pressure and chamber compliance
values. Therefore, larger P
mc
than native values is another requirement for systemic
only mock loop operation. This limitation is not apparent in the complete simulation
model and mock loop results, as the right heart and thus pulmonary venous system
feeds the left atrium. Therefore, venous pressure exceeds left atrial pressure in all
cases, thus providing sufficient venous return to the heart for passive diastolic filling.
Venous Pressure
Venous pressures were maintained at reported physiological levels due to a larger
compliance chamber. This allowed sufficient venous return to the left and right
ventricles, and helped to maintain correct atrial pressures, and consequently
ventricular preload.
The introduction of extra fluid was successful in creating the mean circulatory
pressure. Additional fluid could then increase P
mc
for cases of heart failure and
exercise.
3-63
3.6.3 Vasculature
Faithful reproduction of the vascular resistance and compliance parameters is
essential for cardiovascular reproduction. Table 3-16 and Table 3-17 detail vascular
resistance and compliance respectively in a comparison of systemic (left) and
pulmonary (right) values between native, literature reviewed, physical circulation
loop and simulation model results for rest, left heart failure and exercise.
Table 3-16 Systemic (SVR) and Pulmonary (PVR) Resistance Comparison
Resistance (dyne.s.cm
-5
) Rest LHF Exercise
Native 1463 106 1800 160 718
(Patel, Allaire et al. 2003) 1130 - 1862 - -
(Pantalos, Koenig et al. 2004) 1218 - 2023 - -
Mock Loop (dyne.s.cm
-5
) 1439 133 1266 293 839
Simulation 1552 176 1346 216 -
Table 3-17 Systemic (SAC) and Pulmonary (PAC) Compliance Comparison
Compliance (ml/mmHg) Rest LHF Exercise
Arterial Compliance
Native 1-2 2-4 - - -
(Pantalos, Koenig et al. 2004) 1.3 - 1.3 - -
Mock Loop 1.84 2.95 1.2 2.95 0.4
Simulation 1.5 3 1.3 3 -
Venous Compliance
Native 10-200 4-6 - - -
(Pantalos, Koenig et al. 2004) - - 1.3 - -
Mock Loop 23 7.1 11.5 7.1 11.5
Simulation 22.5 10 22.5 10 -

Resistance
Resistances were determined from values of pressure and flow between each section.
The inherent resistance of each section was fixed by the pipe dimension. However,
gate and ball valves incorporated in the arterial and venous lines could be used to
fine tune individual resistance. Furthermore, the introduction of a proportionally
controlled pinch valve between arterial and venous sections represented a variable
lumped resistance in the body (systemic) and lung (pulmonic) components.
Native and mock loop resistance values for the resting and exercise conditions show
reasonable correlation, with simulation values showing a trend of slightly higher
resistance. The left heart failure condition exhibited a lower resistance in the mock
loop and simulated model to those presented in the literature. This is also contrary to
the native cardiovascular response to LHF, which acts to increase SVR from rest.
3-64
The discrepancy is attributed to the simulated treatment. Higher values of resistance
represent the autoregulatory response to heart failure. However, drug treatment of
heart failure relies to some degree on the reduction of SVR to values approximating
rest. This action reduces the workload on the heart, and results in increased perfusion
at the expense of mean aortic pressure (MAP). Similar results are presented in
Chapter 5 for untreated heart failure prior to LVAD insertion.
Heart valve resistance was set by the physical size of the swing check valves. Despite
the physical diameter of approximately 23mm for native heart valves, larger diameter
swing check valves were incorporated. The atria-ventricular and ventricular-arterial
valve diameters were 40mm and 32mm respectively. The larger diameters not only
account for partial blocking of the flow section by the open swing, but also its heavy
weight. This was essential to maintain passive ventricular filling, and the larger size
also accounts for the lack of atrial contraction.
Compliance
Compliance values of each chamber in the physical circulation system were
evaluated by adding volume to the section and recording the change in pressure. In
the initial condition, the volume of air trapped within each chamber dictated
compliance. However, after the pulse was initiated, the shift of fluid to the arterial
side caused this volume to decrease as pressure rose to the diastolic value. Therefore,
the actual operational value of compliance was slightly less than that measured in the
static initial condition (Table 3-14).
The technique of vertically moving the chamber test plugs was effective in easily
changing arterial and venous compliance according to the physiological condition.
Atrial and ventricular compliances were fixed by the pipe size of each chamber. That
is, a change in fluid level (volume) contained in each chamber gave rise to a pressure
head change due to the vertical displacement of this fluid level.
Compliance values of individual simulation model and mock loop components were
recreated reasonably close to the ranges found in the native circulatory system and
presented in the literature. Arterial compliances were slightly higher, to account for
the inertial effects of the mock vasculature, thus maintaining expected pulse
pressures. Systemic compliance was reduced in the LHF case, as dictated by the
native regulatory response to heart failure.
3-65
3.6.4 Perfusion
Vascular perfusion rates are compared between Native, Literature, Simulation and
Mock Loop values in Table 3-18. Perfusion rates not only relate to total mean flow
(MSQ / MPQ), but peak arterial flow (AoQ
pk
/ PAQ
pk
).
Table 3-18 Comparison of Mock Circulation Loop Perfusion Results
AoQ
pk

(mL/sec)
SQ
(L/min)
PAQ
pk

(mL/sec)
PQ
(L/min)
REST
Native 0 - 600 5 0 500 5
(Pantalos, 2004) 0 - 333 5 - -
(Patel, 2003) - 5.2 - -
Mock Loop - 5.1 - 5.1
Simulation 0 400 5 0 310 5
LHF
(Pantalos, 2004) 0 - 183 3 - -
(Patel, 2003) - 3.3 - -
Mock Loop - 2.7 - 2.7
Simulation 0 - 200 2.67 0 - 190 2.67
EXERCISE
(Patel, 2003) - 7.95 - -
Mock Loop - 9.5 - -

Under normal and failing heart functions, perfusion rates for each physiological
condition were found to pulse with each cardiac cycle, averaging to flow rates
consistent with native and reported values for each condition. However, maximum
flow pulses recorded in the mock loop are somewhat reduced from those predicted in
the simulation model, due to the time constant of the flowmeter.
Native values of perfusion in the complete circulation rig could only be obtained for
conditions of heart failure and rest. Exercise perfusion was only observed in the
systemic only circulation rig. The lack of complete circulation rig ability to achieve
the exercise condition was a direct consequence of the inability to reduce pulmonary
vascular resistance to induce sufficient pulmonary flow for a given pressure gradient.
Values of ventricular ejection in the simulation model were in the range observed
natively, and reported in literature. This was due to the matching of aortic and
pulmonary valve resistance. The 32mm check valves, partially blocked by the swing,
therefore resulted in an equivalent area equal to that of natural heart valves.
3-66
3.6.5 Cardiovascular Interaction and Autoregulation
The goal of the developed simulation and mock circulation rig was to closely
replicate the function of the cardiovascular system for all physiological conditions.
As previously discussed, this requires the replication of individual cardiac and
vascular function. However, their interaction and autoregulation is also of particular
importance.
In simulation and circulation rig applications, a change in cardiac function is met by
a change in vascular parameters, in order to maximise perfusion and maintain
physiological pressures. For example, in simulated left heart failure, a reduction in
left ventricular contractility necessitates an increase in vascular resistance to
maintain mAoP at the expense of flow rate. The cardiovascular system relies on the
activation of baroreceptors for this purpose, however this regulation was provided by
visual mAoP inspection and manual adjustment of SVR in the mock circulation rig
experiments. Implementing a control algorithm to replicate the baroreceptor effect is
a realistic task for future work. Furthermore, the response of the vasculature to
medical drug therapy is evident. That is, a reduction in SVR causes an increase in
perfusion at the expense of MAP.
The most notable interaction observable in the mock circulation rig is the Frank-
Starling effect. As left ventricular contractility function alters (for example due to
heart failure), left heart ejection fraction decreases. This in turn results in a lower
venous return to the right atrium, and thus less right ventricular preload. The
reduced preload negatively affects the pumping ability of the right ventricle, and
consequently right ventricular ejection is also reduced until equilibrium is reached
between right and left cardiac output. When any change in heart function is seen by
either ventricle, the corresponding ventricular functionality is passively altered by
changes in preload, which act to balance perfusion. This phenomenon was
qualitatively observed through the clear ventricular chambers in the mock loop.

3-67
3.7 Conclusion
The techniques employed to recreate the complete human circulatory system
provided an accurate method for physiological pressure and perfusion simulation
throughout the cardiovascular network.
The developed physical mock circulation rig demonstrated the Frank-Starling
response to all physiological conditions, due to the recreation of passive filling
ventricles. Left and/or right ventricular heart function could be independently and
variably controlled, which is difficult to reproduce in an in-vivo animal setting.
Easily variable vascular parameters enable the complete mock circulation system to
recreate native hemodynamics for conditions of rest and medically treated heart
failure. However, due to the inherent resistance of the pulmonary circuit, exercise
could be simulated in the systemic loop only.
The developed SIMULINK model was based on the MATLAB demo Physbe, and
closely matched the physical circulation rig in regards to vascular pressures and
perfusion rates under all physiologically tested conditions. Variations are attributed
to the difference in the system order between model and rig. Despite the limitations,
the simulation model provided a valuable tool to sufficiently verify operation and
diagnose problems throughout the iterative mock loop design process.
The mock circulation rig can be used as a cost effective process to evaluate the
hemodynamic impact of left-, right- and bi- ventricular assist devices on the
circulatory system. Furthermore, the response of physiological controllers can be
assessed by attempting to maintain positive pressures within the ventricular
chambers. Additionally, the pulsatile environment is advantageous for device
endurance tests, although this falls outside the scope of the current design in present
form. Simple modification of rig materials would allow the use of various blood
analogues.
Although the mock loop will not replace in-vivo trials, by improving its performance,
sufficient results may be obtained to refine designs before these expensive and time
intensive trials.

Chapter 4 Centrifugal VAD Design and Development
4-1
Chapter 4
Centrifugal VAD Design and Development

This chapter addresses the design and development of centrifugal pumps for Left,
Right and Bi-Ventricular support applications. Each pump requires the simultaneous
design of the impeller and the volute casing. Consideration for the interaction of
these components on hydraulic performance and impeller force generation must be
taken when selecting their individual design parameters. A custom VAD hydraulic
design procedure, detailed in Appendix B, was formulated as a guide to correctly
design various configurations of each individual pump component.
4-2
4.1 Introduction
Centrifugal pump design is a refined art spanning many decades. Most of the
consulted literature describes similar procedures for component design; however they
generally cater for higher specific speed applications than required of an implantable
VAD. Nevertheless, an attempt was made to integrate these methods into a design
procedure for the development of centrifugal blood pumps suitable for left, right and
bi-ventricular assistance.
Most modern turbo machinery is designed and optimised for a single operating point.
However some applications require the pump to function at a variety of operating
conditions over time. This instantaneous operating point of an implantable VAD
depends on both the level of support required for the failing ventricle, as well as the
period of the cardiac cycle. As the ventricle continues to fail, or indeed improves its
function, the output requirements of the assist device will change. Likewise, as the
natural heart alternates between systole and diastole, the changing inlet conditions
influence the VAD operating point. Therefore, the trade-off between optimal
performance at one operating point and the equally acceptable performance under a
range of operating conditions must be considered (J apikse, Marscher et al. 1997).
Performance of a centrifugal pump is conventionally described by the pump
characteristic curves (characteristic performance). However, when referring to
cardiac assist devices, the term extends to encompass the ability of the device to re-
establish cardiovascular hemodynamic parameters of pressure and flow from
pathological to normal levels (hemodynamic performance). This capability is indeed
influenced by the pump performance characteristic curves, where the gradient of the
curve determines the response of the device to changing physiological conditions
(exercise, rest, etc). A flat curve represents a large variation in flow rate for a small
change pressure head at a given rotational speed, a feature of larger exit angle
impeller vane profiles. This characteristic simplifies the physiological control of the
device by accommodating a large variation in outflow in response to changes in
vascular resistance, with little change in rotational speed.
4-3
Device operation results in fluid pressure distributions within the pump casing. When
variations in pressure exist, hydraulic thrust acts on the impeller. The characteristics
of the axial and radial components are influenced by the impeller type and volute
casing respectively. These force characteristics determine the required load capacity
of magnetic or hydrodynamic impeller suspension systems to minimise impeller
touchdown, and predict wear lifetime of contact bearings (Song, Wood et al. 2004).
The purpose of this chapter is to provide background information on centrifugal
pump design, hydraulic performance and hydraulic force generation. This
information was used to create a number of hydraulically designed components.
4-4
4.2 Background
4.2.1 Centrifugal Pump Design
The centrifugal pump is a constant flow device commonly selected for high pressure,
low volume (low specific speed) applications. Fluid enters the pump inlet axially,
whereby a rotating impeller urges the fluid radially outward. This impeller contains a
number of blades with a specific curvature, which can be fitted to a hub (back
shroud) and front shroud. The fluid is collected by the casing and guided into a
radially orientated outlet. A number of casing configurations are possible to achieve
the goal of fluid velocity deceleration and thus pressure increase.
This section describes the various components of a centrifugal pump that may be
considered for application to ventricular assist devices.
Impeller
A centrifugal pump imparts energy to the fluid via a motor driven impeller rotating
about a central axis. The application of centrifugal forces to the fluid within the
impeller is aided by protruding vanes. Variations in vane, shroud and geometrical
configuration compose the variety of impeller types.
Vane Configurations
Vane Angles and Shape
The vane angle configuration determines the nature of the impeller type, i.e. forward,
straight and backward facing.
Entrance vane angles range between 15-50 (Curtas, Wood et al. 2002), while
discharge angles lie between 15-35 with a normal range from 20-25 (Stepanoff
1957; Curtas, Wood et al. 2002). Discharge angles greater than 90 result in
increased head with capacity, although at the expense of efficiency. This is suggested
to only arise by impulse action, which is not recommended when collecting the high
velocity jets and converting them into pressure (Stepanoff 1957).

4-5
Vane Number
The number of vanes on a centrifugal pump impeller influences the degree of relative
recirculation within the impeller. As a consequence, relative velocity distributions at
impeller inlet and exit are affected due to the inertia effect of frictionless particles.
Particles retain their orientation as the impeller rotates and therefore the particle fails
to turn with the impeller. Superposition of the recirculation flow to the flow through
the impeller reduces the velocity at the front face of the vane whilst increasing it at
the back face. This produces a velocity component in the tangential direction
opposite to the discharge velocity (c
u2
) and additional to the entrance velocity (c
u1
),
both of which act to reduce developed pressure head.
This relative recirculation is reduced with an increasing blade number; hence the
pump head is higher in this case. However, the blades act to partially block flow
from impeller eye to exit, thus a high blade number has the negative effect of
reducing pump capacity.
Slip
While the physical inlet and outlet vane angles of the impeller influence the angle of
the input and discharge velocity respectively, they are not always coincident.
In an established flow, a body must move faster than the established velocity of flow
in order to exert any force on the liquid flowing in the same direction. I.e. The vane
must have an impelling action.
The relative recirculation in the vanes has an effect of decreasing the discharge angle
(
2
to
2
), while the input angle (
1
) is increased (
1
). Should the blade angle be
changed (to
2
), the liquid would still lag the impeller angle and output at an angle
(of
2
). Slip is influenced by the number of vanes and the vane discharge angles.
4-6
Shroud Configuration
There are three common impeller shroud configurations found in centrifugal pumps;
fully enclosed (shrouded), open or partially open.
Enclosed (Shrouded) Impeller
An enclosed impeller design features a shroud covering the top and bottom of the
impeller vanes. This type of impeller configuration confines the fluid into the vane
space, resulting in friction losses due to fluid flow relative to the inner side of the
shroud (
2
/2g). Leakage from impeller exit to inlet is introduced in the small
clearance gap between the upper shroud and casing, while fluid stagnates beneath the
lower shroud.
Open Impeller
An open impeller design improves performance of medium to high specific speed
pumps (n
s
=2500-6000) (Stepanoff 1957). This is a direct result of the reduction in
disc friction losses by eliminating the front shroud. Instead, this loss is replaced by a
hydraulic friction loss caused from the relative fluid flow against a stationary wall
(c
2
/2g).
Removing the shroud eliminates leakage between the shroud and casing; however it
introduces a new leakage from front to back side of the impeller vanes. This loss is
generally considered to be similar to that of a closed impeller, providing a minimum
working clearance is maintained. Increasing the clearance leads to a higher level of
leakage and thus a reduction in efficiency.
Partially (Semi) Open Impeller Design
A partially open impeller design incorporates a number of vanes protruding from a
lower shroud (hub) only. The upper shroud is removed, resulting in leakage between
impeller vanes as well as the stagnation of fluid beneath the lower shroud.

4-7
Inlet Volute
The fluid passage from suction nozzle to impeller eye can take on a number of forms.
The simplest are straight or curved elbow inlets. Advanced inlet designs, such as a
side suction volute, produce a level of inlet pre-swirl as a result of a baffle or splitter
(Lobanoff and Ross 1985; J apikse, Marscher et al. 1997). Most inlets are designed to
accelerate the fluid by reducing the area approaching the impeller eye, thus reducing
boundary layer losses.
Volute Casing
A volute casing surrounds the circumference of the impeller of a centrifugal pump
(Figure 4-2(a)). The impeller discharges the pumping medium directly into this
volute, which is commonly a spiral shaped flow passage, of circular or trapezoidal
cross section that gradually increases from the tongue to throat (Tuzson 2000).
The two basic functions of the volute are to collect and discharge the fluid through
the outlet, and the conversion of fluid kinetic energy (imparted by the impeller) to
pressure energy (Lobanoff and Ross 1985).
Since the fluid leaving the impeller is travelling at a considerably greater velocity
than that in the delivery pipe, this velocity reduction and thus energy conversion is
the primary objective of the volute. Further energy recuperation is performed in the
outlet diffuser (Lazarkiewicz and Troskolanski 1965). The volute does not generate
dynamic head, rather functioning to minimise losses in the energy conversion
process (Lobanoff and Ross 1985). This diffusion inefficiency accounts for the major
part of pump losses (Tuzson 2000), therefore pump efficiency depends on the
smallest loss of energy during this process (Lazarkiewicz and Troskolanski 1965).
4-8
Assumption of Flow in Volute
The condition of constant flow momentum or velocity must be assumed when
deciding the volute design technique to be employed.
The assumption of constant momentum presumes that the fluid obeys the principle of
conservation of momentum. This suggests the fluid momentum is constant from the
impeller tip to an arbitrary radius. In order to achieve this however, the velocity must
decrease since the radius increases. The result is a declining mean velocity of flow in
the volute from the volute tongue to the throat. This theory holds true for perfect
liquids, and does not take the effect of friction into account (Lazarkiewicz and
Troskolanski 1965). For a constant volute width, the liquid path in the volute takes
the form of a logarithmic spiral (Lazarkiewicz and Troskolanski 1965). .
The best modern pumps are designed for constant average velocity for all volute
sections, since it was revealed that the measured tangential velocity components of
the fluid did not follow the law of constant angular momentum (Stepanoff 1957).
This is achieved by designing the area of the volute to increase proportionally to the
increase of angle from the tongue to the throat (Logarithmic spiral).
Comparison of Constant Momentum and Velocity Methods
There is little difference in pump efficiency resulting from either method; however
there are slight variations in pressure distribution around the volute, likely due to the
variation of velocity within the volute (Figure 4-1). As far as volute dimension
design is concerned, the constant velocity method is considerably simpler to
calculate (Lazarkiewicz and Troskolanski 1965).

Figure 4-1 Volute velocity assuming constant momentum (a) and constant velocity (b)
(Lazarkiewicz and Troskolanski 1965)
4-9
Volute Types
The entire pump capacity passes through the volute throat, while only part of the
capacity passes other volute sections. Therefore, the volute area should increase
from the tongue to the throat to accommodate discharge from the impeller periphery
(Stepanoff 1957). This is the case for the conventional single and double volute
configurations; however some instances call for a circular or concentric volute. Each
of these volute types are discussed in the following sections.
Single Volute
A single volute (Figure 4-2(a)) is the most common type of casing, which increases
in cross sectional area from the tongue to throat. Single volute designs are often used
for low capacity/low specific speed applications (Lobanoff and Ross 1985).
Double Volute
The double volute is either two single volutes in an opposed arrangement, or one
single volute split by a dividing plate (Figure 4-2(b)). To provide adequate discharge
flow, the total discharge area (throat area) of the resulting two volutes is comparable
to that of a single volute (Lobanoff and Ross 1985).
Circular Volutes
A circular volute (Figure 4-2(c)) consists of a concentric casing surrounding the
periphery of the impeller. The circular casing should be considered when designing
pump with a specific speed between 500 600 (Lobanoff and Ross 1985). When
designing the geometry of a circular volute, the ratio of volute diameter to impeller
diameter should not be less than 1.15 or more than 1.2 and the width should suit the
impeller width. The capacity at the BEP is controlled by the outlet diameter, and
should be sized according to the value of throat velocity.

(a) Single Volute (b) Double Volute (c) Circular Volute
Figure 4-2 Volute Configurations

4-10
Specialised Volutes
In some cases, the final volute design is a combination of conventional volute
designs. That is, the volute shape may initially follow the spiral volute until a certain
point where it reverts to a circular volute, or vice versa. Alternatively, the double
volutes may employ a splitter that does not reach the pump discharge nozzle, but
rather terminating at an arbitrary point within the volute. The design of such
specialised volutes is undertaken to meet the requirements of a specific application.
Volute Cross-Sectional Areas
In some cases, a correctly designed volute with smooth walls and a conical diffuser,
can obtain efficiencies in excess of 90%. This is partly due to the shape of the
volutes cross section (Figure 4-3). These circular and trapezoidal shapes are the
most frequently used in single stage pumps (Lazarkiewicz and Troskolanski 1965).

Figure 4-3 Types of volute cross sections
The velocity distribution within the cross section is not uniform, with a mean
velocity just 0.78 - 0.92 V
max
. This velocity ratio is lower in comparison to that in
pipe flow, mainly due to the high velocity core of the flowing fluid caused by the
rotating impeller (Stepanoff 1957).
It is advised to increase the final ideal volute design cross sectional area by 15-25%
to account for losses and boundary layers (Tuzson 2000).
When designing a volute for low to medium specific speed (<1100), a rectangular
volute should be considered. This arrangement is not only easier to manufacture, but
the hydraulic losses are minimal over the relatively low N
s
range (Lobanoff and Ross
1985). For a blood pump application the volute corners should be filleted to reduce
the potential for thrombus formation in the sharp corners.

4-11
Diffuser
The diffuser is the transitional section of the pump from volute throat to delivery
pipe. It is an extension of the volute, often used to convert the last amount of kinetic
energy into delivery pressure (Stepanoff 1957).
If the velocity at the volute throat equals that at the exit flange, no diffusion is
necessary (Tuzson 2000). However, if the final cross section of the volute throat is
less than the bore of the discharge flange, the transition to match the size difference
should be performed by a diffuser. The angle of the transition (Figure 4-4) should
not exceed a designed value (7-13), so as to avoid fluid separation from the walls
(Lazarkiewicz and Troskolanski 1965; Lobanoff and Ross 1985). Figure 4-5
displays the relation between the taper angle and the velocity of volute flow
(Lazarkiewicz and Troskolanski 1965).

Figure 4-4 Volute design
parameters (Lazarkiewicz and
Troskolanski 1965)
Figure 4-5 Taper Angle Vs Throat Velocity
If the volute cross section is circular, the diffuser should take the shape of a truncated
cone. However, in some cases the volute cross section is not circular, rather
trapezoidal, rectangular or a more universal shape. In such cases, the mean angle of
divergence is found by relating the unique shape to an equivalent circular cross
section (Lazarkiewicz and Troskolanski 1965).

4-12
4.2.2 Hydraulic Performance
Ventricular assist devices benefit from a flat pump characteristic curve. This feature
provides a favourable physiological response to changes in systemic resistance. That
is, smaller changes in rotational speed are required to maintain a set aortic pressure at
flow rates required for varying physiological conditions. This section discusses the
parameters that affect the hydraulic performance curve, such as impeller blade
discharge angle, and axial clearance gap.
Impeller Discharge Angle
The idealised performance characteristic curve of a centrifugal pump depends on the
value of discharge blade angle. This produces a dimensionless linear pressure
response with flow capacity when friction, separation, slip, recirculation and
blockage losses are neglected (Figure 4-6). Slip between the finite blades will
decrease the value of discharge angle, which results in a reduction of developed
head. Recirculation affects volumetric efficiency, and occurs between the impeller
and cutwater, as well as over semi-open or open type impeller blades. Friction losses
are dependant on fluid viscosity, and create boundary layers which combine with
blade thickness to create impeller blockage. These losses significantly contribute to
the actual curve, however their magnitude is difficult to theoretically predict.

Figure 4-6 - Non-Dimensional Performance for Different Discharge Blade Angles
22.5
90
112.5
4-13
Backward Curved Blades < 90
Backward curved blades are recommended for high efficiency, with a blade angle of
22.5 demonstrating best efficiency.
Radial Blades = 90
A radial blade impeller exhibits a flat performance curve up to 75 percent of BEP,
beyond which the curve is very steep (Karassik, Messina et al. 2000). This impeller
type is characterised by lower efficiency.
Forward Curved Blades > 90
Forward curved blade impellers have received relatively little research attention, and
as such an efficient design has not been forthcoming. This may be related to the
difficulties in realising a casing that can catch and convert the high velocity jets
leaving the vane tips into pressure, while permitting impulse action (Stepanoff 1957).
Attempts to simulate this type by reversing the rotational direction of backward
curved impellers resulted in poor efficiencies (Karassik, Messina et al. 2000).
Axial Clearance
The axial clearance between impeller top shroud and casing affects the head,
capacity and thus efficiency of the centrifugal pump. This effect is more pronounced
in semi-open type impellers with a high axial clearance to impeller width (b
2
) ratio.
A ratio of 0.05 is determined as 100% efficient, with a ratio of 0.6 resulting in a
reduced efficiency to 62.5% (Stepanoff 1957).
Therefore, a variation in axial clearance will affect the location (in the y-axis), but
not the gradient of the performance curve.
4-14
Volute
Single
Pump designs that integrate this volute with a constant velocity regime are generally
more efficient than the more complicated counterparts.
Double
The hydraulic performance of the double volute almost attains the efficiency of the
conventional single volute at B.E.P. However, it outperforms it considerably at off
design conditions, resulting in a more efficient design over the full range of pumping
capacities (Stepanoff 1957; Lobanoff and Ross 1985). This improvement is due to
the impeller discharging fluid into a more uniform pressure distribution (Stepanoff
1957).
The double volute arrangement is characterised as exhibiting greater efficiency at off
design points, however a slightly lower efficiency at design point to that of a single
volute is evident (Lobanoff and Ross 1985).
Circular
Circular volutes are used to improve the hydraulic performance of small, high head
or low specific speed units, but they impair high specific speed units. The efficiency
of pumps incorporating a circular volute is higher for pumps with a specific speed
less than 600, with the efficiency dropping to 95% of a conventional volute at higher
specific speeds (Lobanoff and Ross 1985).
The casing losses are not as significant in low specific speed (N
s
)

applications due to
a generally improved surface finish in these pumps.

4-15
4.2.3 Hydraulic Force
The impeller of a centrifugal pump encounters hydraulic forces in both radial
(perpendicular to axis of rotation) and axial (parallel to axis of rotation) directions.
These forces are composed of static (steady) and dynamic (unsteady) components
(Flack and Allaire 1984).
Radial Thrust
Radial (x,y) forces encountered by the impeller of a centrifugal pump are directed
perpendicular to the axis of shaft rotation, and are composed of a dynamic cyclic
component superimposed on a static steady state load. The static component is due
to non-uniform pressure distribution around the impeller, while whirl/diffuser
interactions form the dynamic component. Labyrinth forces contribute to both static
and dynamic elements (Guelich, J ud et al. 1987; Karassik, Messina et al. 2000).
Non-uniform flow distribution at inlet, and static rotor eccentricity, can also
contribute to steady radial forces. The latter particularly affects the contribution to
steady radial forces of an axial labyrinth. An axial labyrinth (clearance gap between
impeller and casing parallel to axis of rotation) simulates a journal bearing when the
rotor is statically eccentric. This situation effectively changes the magnitude and
direction of the resultant radial force by providing a restoring force and a tangential
force due to the impeller rotation. The impeller will therefore rotate and vibrate about
a new eccentric origin (Guelich, J ud et al. 1987). This eccentric rotor assembly may
actually whirl at a natural frequency even though the shaft may rotate well above this
speed (Adkins and Brennen 1988).
From a stability and dynamic response viewpoint, the reduction of dynamic forces
are far more important for improved industrial pump lifetime (Flack and Allaire
1984). This statement presumably emphasizes the nature of many shaft failures
resulting from fatigue fractures due to cyclic loading for extended periods. Although
static impeller forces contribute to excess shaft deflection and bearing wear
(Stepanoff 1957; Lazarkiewicz and Troskolanski 1965; Guyton 1971; Baun and
Flack 2003), the magnitudes can be factored into shaft size and bearing capacity
designs.
4-16
Static Radial
Steady radial (x,y) thrust predominantly arises from the non-uniform fluid pressure
distribution around the impeller circumference caused by asymmetric flow (J ery
1985; Guelich, J ud et al. 1987). Mismatch of absolute impeller fluid discharge
velocity and volute spiral angle also contributes to radial thrust by creating
separation at the cutwater. The magnitude, direction and trend with respect to flow
capacity depend on the operational specific speed and casing/volute type employed
(Guelich, J ud et al. 1987). Figure 4-7 describes the static radial thrust characteristics
of the common volute types investigated over all flow capacities. These trends are
examined in more detail in the following sections.

Figure 4-7 Variations in Static Radial Thrust of Common Volute Types

Effect of Volute Type
The type of volute within which the impeller operates significantly affects the
magnitudes, directions and trend characteristics of static radial force. Single volutes
encounter lowest radial force at the best efficiency point, while this condition occurs
at shut-off for circular casings. The radial force magnitudes of double volute designs
are relatively low and do not significantly vary over all operating capacities.
BEP
Single Volute
Circular Volute
Double Volute
Capacity (Q)
R
a
d
i
a
l

F
o
r
c
e

4-17
Single Volute
Single volutes provide uniform impeller discharge, and thus pressure distribution
around the impeller circumference, when operating at design conditions. This occurs
at one operating point only (Uchida, Imaichi et al. 1971; Lobanoff and Ross 1985;
Lorett and Gopalakrishnan 1986; Baun and Flack 1999). This condition theoretically
produces a balanced radial force; however a small but minimal steady state force
exists at or near the design point (Lazarkiewicz and Troskolanski 1965; Flack and
Allaire 1984; Guelich, J ud et al. 1987; Baun and Flack 1999).
A volute designed assuming constant fluid velocity at the operating point is
favourable when considering radial force, since pressure distribution is theoretically
the same in all volute sections (Stepanoff 1957). However, the static radial thrust
force characteristics are similar for volutes assuming constant momentum (Guelich,
J ud et al. 1987).
Pressure uniformity is destroyed when asymmetric flow results from operating the
pump at off-design conditions (Figure 4-8), or impeller displacement from design
centre by shaft misalignment/deflection (Stepanoff 1957; Lorett and Gopalakrishnan
1986; Guelich, J ud et al. 1987; Adkins and Brennen 1988) These situations produce
a degree of static radial impeller thrust. The direction and magnitude of this force
depends on the extent of pressure asymmetry, which is determined by the operating
point in relation to the design flow rate, and is influenced by specific speed
(Lazarkiewicz and Troskolanski 1965).

Figure 4-8 Single Volute Fluid Velocity at Various Flow Conditions (Q).
(a) Shut-off , (b) Design Flow and (c) Above Design Flow
4-18
Operation at Part Design Capacity
The destruction of pressure uniformity at part load in a single volute pump is
attributed to flow separation at the suction side of the tongue, resulting from a
smaller flow angle leaving the impeller to the geometric angle of the tongue. When
entering the stalled or recirculation zone (where flow is zero), little pressure recovery
occurs in first half of the volute. Therefore, deceleration occurs in the second half of
the volute, resulting in an increased pressure in this region, causing a thrust force
directed to the stalled region (Guelich, J ud et al. 1987). Radial thrust at part design
capacities generally acts toward the cutwater, shown in Figure 4-9. The actual
direction within the range presented, is dependant on the relative magnitudes of the
suction effect of separation at the cutwater, coupled with the positive pressure effect
of decelerating fluid at volute exit. The consequences of these relative vectors in
relation to specific speed are described in further detail later.

Figure 4-9 - Radial Thrust Direction at Operation Below Design Capacity
(Guelich, Jud et al. 1987)

Operation at Shut-Off
The maximum radial force theoretically occurs at zero capacity (Lazarkiewicz and
Troskolanski 1965), since impeller-volute angle mismatch and fluid deceleration is
maximum at this point. However, the maximum force practically depends on the
pump characteristic curve, since it dictates the flow rate that output pressure is a
maximum. This is evident in a study conducted by (Flack and Allaire 1984) where
maximum radial force was measured at 19% of design capacity.
4-19
Operation Above Design Capacity
Uniformity is again destroyed at flow rates above design conditions. The separation
region shifts to the outlet side of the tongue, as a result of larger flow discharge
angles off the impeller. Therefore, pressure builds up on the inside of the tongue. In
addition to this, fluid velocity at the throat is higher than that at the impeller exit,
causing the fluid to accelerate toward the throat, and thus drop static pressure.
Radial force under these circumstances acts away from the volute tongue (Figure
4-10), and again depends on the relative magnitudes of cutwater and acceleration
vector components of force.

Figure 4-10 - Radial Thrust Direction at Operation Above Design Capacity

4-20
Double / Split Volute
A double/split volute attempts to balance the distribution of pressure around the
impeller circumference, effectively reducing radial thrust at off design conditions of
a single stage pump (Figure 4-11) (Stepanoff 1957; Lazarkiewicz and Troskolanski
1965; Lobanoff and Ross 1985; J apikse, Marscher et al. 1997; Karassik, Messina et
al. 2000).
Force minimisation is attributed to a second stalled region (Figure 4-11) created at
180
o
from the original cutwater, which considerably increases flow symmetry and
pressure distribution at off design conditions (Guelich, J ud et al. 1987). Volutes of
this design are often termed double or split type, though each description features a
subtle difference. That is, the double volute has a constant outer channel area, while
the splitter has an expanding outer channel area.
Non-uniformity in the double volute casing develops from different fluid resistances
of inner and outer volute channels. The double volute arrangement is therefore
sensitive to the geometrical tolerance of both cutwater and volute passages, and can
easily destroy pressure distribution symmetry (Stepanoff 1957; Guelich, J ud et al.
1987). Consequently, the double volute will greatly reduce, but not completely
eliminate radial thrust (Lobanoff and Ross 1985).

Figure 4-11 Flow Separation Regions in a Double Volute at Part Capacities

4-21
Modified Concentric / Volute
A number of techniques have been investigated to reduce static and dynamic radial
thrust by modifying the volute casing. Cutting back the cutwater or tongue, and
forming a concentric volute over the first 90 degrees, eliminates the stalled region at
the volute tongue at part loads since the volute tongue angle is reduced and better
matches the discharge angle from the impeller (Figure 4-12).
This technique results in a reduced thrust force at part loads (Guelich, J ud et al.
1987) at the expense of efficiency, since recirculation is increased (Uchida, Imaichi
et al. 1971). Extending the concentric volute to 270 degrees before reverting to a
volute type casing to discharge also produces a marked reduction in radial force
relative to a single volute (Lazarkiewicz and Troskolanski 1965).

Figure 4-12 Modified Concentric Volute

Concentric
Symmetrical pressure distribution and thus minimal radial force occurs at zero flow
(shut-off) conditions in a concentric volute. This uniformity is destroyed as the
capacity increases, leading to increased radial loads and casing losses. Non-uniform
pressure is therefore often realised at BEP (Lobanoff and Ross 1985; Karassik,
Messina et al. 2000), which leads to a maximum radial force (Stepanoff 1957). A
reduction of radial load may be realised by adding material to the cutwater, which
effectively reduces fluid recirculation at the tongue (Lobanoff and Ross 1985).
4-22
Static Radial Force Calculation
The radial force encountered by the impeller of a centrifugal pump is often difficult
to theoretically predict. Therefore, many authors have derived specific formulas
based on experimental data to aid in the initial estimation of magnitude (Stepanoff
1957; Lazarkiewicz and Troskolanski 1965; Lobanoff and Ross 1985; Lorett and
Gopalakrishnan 1986; Karassik, Messina et al. 2000). These calculations are not
common, and no standard method has been accepted (J apikse, Marscher et al. 1997).
Radial thrust direction is even more difficult to predict exactly, however general
trends are identified in relation to output capacity.
Magnitude
The magnitude of radial thrust varies for each volute type. Equations for radial thrust
calculation (detailed in Appendix C) are provided by:
1. Stepanoff, (Stepanoff 1957)
2. Lobanoff/ANSI/HI, (Lobanoff and Ross 1985; ANSI/HI 1994)
3. Karassik (Karassik, Messina et al. 2000)
Each technique is based on knowledge of the output pump head, which acts on the
impeller peripheral area (including shrouds). This resultant force is multiplied by an
experimentally determined thrust factor K, which varies in magnitude from shut-
off, to above design conditions, at a trend dependant on the volute type.
These equations are implemented to predict the radial force expected in the single
sided LVAD condition. Comparison to the experimental force results presented later
in this chapter will reveal the most appropriate equation for use in future centrifugal
VAD designs.
Direction
The exact direction of radial thrust throughout the full capacity range depends on the
pump specific speed (N
s
). However, resultant force generally acts toward the
cutwater during part flow, and away during high flow for all specific speeds in a
single volute casing.
The magnitude and general direction of radial thrust depends on the operating
capacity relative to the design capacity. This radial thrust vector can be further
analysed into two individual vector components. The first represents the force due to
4-23
separation/increased pressure at the cutwater, while the second vector is influenced
by the degree of acceleration/deceleration upstream from the volute throat. The
resultant vector is therefore influenced by the relative magnitude of each component.
The individual component magnitudes are dependant on specific speed. The relative
impeller-volute angle mismatch has a larger range with higher N
s
pumps operating at
part flow conditions. Therefore, the separation vector is dominant and is most
influential in radial thrust direction. On the other hand, the impeller-volute match
angle is smaller in pumps of low N
s
, and thus a lower range of mismatch can occur
while operating at off design. This results in a dominance of the acceleration/
deceleration vector component, since the degree of separation at the cutwater is
limited.
This observation is supported by the results displayed in Figure 4-13. Thrust
direction for higher N
s
pumps at shut off is dominated by cutwater separation, and
thus lies in the 2
nd
quadrant. The direction for low N
s
pumps has a reducing tendency
to act toward the cutwater, and thus projects into the 3
rd
quadrant. Similarly, for
conditions above design, the higher N
s
pumps are dominated by the pressure build up
at cutwater, while a lower N
s
is influenced by volute exit acceleration.

Figure 4-13 - Radial Thrust Direction for Single Volutes
(Karassik, Messina et al. 2000) (Agostinelli, Nobles et al. 1960; Lazarkiewicz and
Troskolanski 1965)

4-24
Dynamic Radial
Unsteady radial forces arise from cyclic fluctuations that occur at sub-synchronous,
super-synchronous or synchronous frequencies relative to the impeller speed.
The tolerance of an impellers manufacture can lead to unbalances due to pressure
fluctuations created from a blade of different discharge angle. This hydraulic
imbalance has the same frequency as the impeller rotational speed and is thus termed
synchronous (Flack and Allaire 1984).
Low frequency or sub-synchronous fluctuations that result from separation of flow at
part loads will increase at rotating stall (shut-off) operating conditions, and can be
destabilising (Flack and Allaire 1984; Guelich, J ud et al. 1987; Karassik, Messina et
al. 2000).
High frequency (super-synchronous) fluctuations are generated at the blade passing
frequency due to the finite blade number.
Impeller/diffuser interactions contribute to the dynamic force when the impeller
vibrates or whirls about the origin. This vibration also causes a variable pressure
distribution about the impeller, since the distance from tip to casing varies. However
the magnitude is significantly lower than labyrinth forces and is often neglected
(Guelich, J ud et al. 1987).
Dynamic forces are difficult to predict, and are significant at 30% design capacity
with a frequency in the order of 1/10
th
rotational speed (Flack and Allaire 1984).

4-25
Axial Thrust
The thrust in the axial (z) direction of a centrifugal pump impeller results from a
difference in pressure distribution acting on the hub and top shroud faces. Many
factors contribute to axial thrust, such as impeller diameter, labyrinths, pump head,
and momentum change through the impeller. Accurate prediction of axial thrust is
therefore only possible with supplemental experimental data (Guelich, J ud et al.
1987). Impeller type also has a considerable effect on axial thrust, with the
magnitude of force decreasing for the semi-open, open and closed type respectively
(Figure 4-14). A number of methods for reducing axial thrust are implemented
industrially, including radial ribs, balance holes and double suction type impellers.
These techniques are sometimes used in blood pump design, with the additional aim
to improve secondary flow beneath the impeller and reduce thrombosis formation.

Figure 4-14 Variations in Static Axial Thrust in all Volute Types

A
x
i
a
l

F
o
r
c
e

Capacity (Q)
Closed Type
Semi-Open Type
Best Efficiency Point
4-26
Static Axial
The static axial thrust developed in single suction centrifugal pumps is due to
asymmetry between the high discharge pressures acting on the underside of the
impeller, and the suction pressure acting on the impeller front (Stepanoff 1957). The
pressure encountered by the underside of the impeller is maximum at the periphery,
and reduces as the axis of rotation is approached, due to the whirling effect of the
liquid (Lazarkiewicz and Troskolanski 1965).
Impeller Types
Closed
The closed impeller produces minimal axial thrust as back shroud pressure is
countered by front shroud pressure (Figure 4-15).

Figure 4-15 Variations in Static Axial Thrust in an Closed Type Impeller
Semi Open
Semi-open impeller types tend to produce a higher value of axial thrust, since back
shroud pressure is only partly opposed the diminishing pressure acting on the top of
the hub (Figure 4-16) (Stepanoff 1957; Lazarkiewicz and Troskolanski 1965;
Karassik, Messina et al. 2000).

Figure 4-16 Variations in Static Axial Thrust in a Semi-Open Type Impeller
Open
Fully open impellers produce a somewhat larger axial force than closed types, but
less force than semi-open types (Karassik, Messina et al. 2000).
4-27
Balancing Axial Thrust
Techniques implemented industrially for balancing axial thrust are usually
undertaken at the expense of hydraulic efficiency (J apikse, Marscher et al. 1997).
Although these methods may achieve the desired reduction in axial thrust, their
suitability for use in blood pumps should be carefully considered.
Balancing Holes
To attempt to equalise the asymmetric axial pressures, four to eight balance holes are
drilled between the inlet blades through to the underside of the impeller (Figure
4-17(a)). This allows communication of fluid from impeller back to front, however
equilibrium is not reached in practice owing to the resistance to flow of the holes.
Additionally, this technique can potentially reduce efficiency due to loss of delivery
through the holes, coupled with a flow disturbance at the inlet (Stepanoff 1957;
Lazarkiewicz and Troskolanski 1965).
This technique has the added benefit of providing a degree of washout beneath the
impeller of a blood pump. A reduction in stagnation is observed and thus the
incidence of thrombus formation is somewhat reduced (Nishida, Yamane et al.
1998).

Figure 4-17 Techniques for Balancing Axial Thrust
(Japikse, Marscher et al. 1997)
4-28
Radial Ribs
Installing four to six radial ribs to the underside of the impeller (Figure 4-17 (b)) is
the most effective way of reducing the axial thrust generated during operation
(Stepanoff 1957). This technique effectively reduces the pressure within this cavity,
by causing the fluid to rotate at the impellers speed. This results in a reduced upward
axial force and therefore reduced overall axial force. However this is at the expense
of an additional power requirement and thus loss of efficiency (Stepanoff 1957;
Lazarkiewicz and Troskolanski 1965; J apikse, Marscher et al. 1997).
Radial ribs (secondary vanes) have been investigated for use in blood pumps, again
in an attempt to improve flow patterns beneath the impeller shroud to reduce
thrombosis (Ohara, Makinouchi et al. 1994; Ichikawa, Nonaka et al. 2002).
Double Suction
By introducing an additional inlet (Figure 4-17 (c)), axial forces on the impeller are
theoretically balanced due to symmetry (Stepanoff 1957; Lazarkiewicz and
Troskolanski 1965; Lobanoff and Ross 1985). However, a residual force is
apparent in most practical applications (Stepanoff 1957; J apikse, Marscher et al.
1997; Karassik, Messina et al. 2000), and in fact is somewhat encouraged (Lobanoff
and Ross 1985). A small axial unbalanced is recommended to lightly load the
impeller bearings in one direction, and therefore prevent floating of the rotor.
Unbalance may arise from non-uniform fluid entrance to the impeller eye and
different piping conditions near the impeller eye (Karassik, Messina et al. 2000).
A double suction impeller will eliminate stagnation beneath the impeller of a single
sided centrifugal blood pump. However, the requirement for an extra inlet may
increase device size, and therefore must be carefully designed to maintain a small
device.

4-29
Static Axial Force Calculation
Magnitude
The magnitude of axial thrust varies for each impeller type. Equations for axial
thrust, detailed in Appendix C, are provided by;
1. Lazarkiewicz (Lazarkiewicz and Troskolanski 1965)
2. Stepanoff (Stepanoff 1957)
3. Lobanoff (Lobanoff and Ross 1985)
4. ANSI/HI (ANSI/HI 1994)
Each method for axial thrust calculation accounts for the contribution of fluid
momentum and pressure distribution underneath and above the impeller. The
calculations assume the geometry of the impeller and characteristic performance
pressure is known. Values of axial thrust at all capacities can be inferred from this
data. Finally, the weight of the impeller is generally not included, and therefore must
be added to the value of axial thrust for pumps operated in the vertical position.
Direction
Three force vectors, that each act in the direction of the impeller rotational axis;
resolve to produce an axial force toward the suction eye. The component generated
from pressure distribution on the impeller bottom contributes to this direction,
opposed by the pressure acting on the top shroud as well as the small contribution of
the fluid momentum component, generated from the change of fluid direction.
Dynamic Axial
Dynamic forces encountered in the axial direction increase in the recirculation zone
encountered at low capacity, and cause cyclic stress to the shaft and bearing. Since
the axial momentum is quite low for radial impellers, slight changes in capacity do
not result in significant dynamic forces (Karassik, Messina et al. 2000).
Additionally, most practical applications operate under relatively static pressure and
capacity, and thus dynamic axial thrust is not as significant as dynamic radial thrust.
The pressure and capacity of an implantable VAD is not static when supporting a
failing ventricle. However, since the operating conditions change with each heart
beat, the frequency is low. Therefore, the axial force alternates between static values
determined by the operating points during the systolic and diastolic periods.
4-30
Additional Impeller Forces
Gravity / Buoyancy
The mass of the impeller is affected by gravitational acceleration, which produces a
static force on the rotor. The magnitude of the static force is directly related to the
mass of the rotor, since the gravitational constant remains unchanged. For example, a
typical rotor mass of 50grams would produce a force of 0.49N.
To counter gravitational effects, the density of the rotor can be matched with that of
the surrounding fluid. For example, a rotor would become buoyant in a blood
environment should its density equal 1050 kg/m
3
.
Inertia
The rotor is exposed to inertial effects as the pump changes direction, which occurs
as the patient ambulates, or indeed as the remaining cardiac function alternates
between systole and diastole. The impeller will continue its motion until an opposing
force produced by the bearing system acts on it.
The magnitude of this force is dependant on the acceleration/deceleration of the
pump in the patient, which is expected not to increase above 2-3 G in everyday
activity (Tansley, Cook et al. 2000). Again, with a typical rotor mass of 50 grams, a
restoration force of 1.0 - 1.5 N would be required in this case.
Hydrostatic Forces / Damping
Hydrostatic forces are also present in a centrifugal pump. This type of force acting
on the impeller is predominant in labyrinth (clearance) sections. Any movement of
the impeller from its central axial or radial position will be met by an opposing
hydrostatic force. The magnitude of this force is dictated by the fluid properties, and
is dominated by viscosity. Some degree of damping also results to restrict the
dynamic motion of the rotor.
4-31
Hydrodynamic Forces
Hydrodynamic force relates to the restoration forces produced in the clearance gaps
of a fluid film bearing. Impellers that incorporate tapered wedges or journal sections
benefit from the production of these forces; however the magnitude is influenced by
the relative surface velocities and fluid viscosity.
When employing a hydrodynamic bearing, the gravitational force mentioned
previously benefits the stability of the system by introducing a bias force. The
direction of the force should coincide with the direction of the fluid film.
Magnetic Negative Stiffness
Some third generation centrifugal VADs employ a motor that magnetically couples
a stator core and coils to magnets embedded within the impeller. This coupling
produces an attractive force from rotor magnet to iron stator core, which is amplified
as the rotor moves from the neutral position, and thus destabilises the system. The
magnitude of the destabilisation force depends on the magnetic material strength and
distance to stator (air gap), and must be overcome by the bearing system. For
example, a negative stiffness of 20N/mm produced in a magnetic bearing application
would require a restoration force of 20N should the impeller displace 1mm from its
neutral position.
Gyroscopic Forces
Gyroscopic forces are encountered by the rotor of an implantable centrifugal blood
pump when a patient bends or turns. The magnitude of these forces depends on the
impeller operating rotational speed, impeller moment of inertia, and rate of
turn/bend. For a typical impeller diameter (50mm) and mass (50 grams) rotating at
2000 rpm while precessing at 1 revolution per second, a restoring toque of 0.02 Nm
is expected, which roughly translates to a force of 0.85 N at the outer diameter.

4-32
4.3 Design Procedure and Parameter Calculation
The procedure used for each VAD application is outlined in Appendix B. This
procedure outlines the various design parameters assumed or calculated from graphs
and equations given by numerous pump design authors. The procedure was
reproduced in MATLAB to enable efficient calculation of parameters.
Impeller design is initially undertaken to determine the operational rotational speed,
diameter and specific speed. The design then focuses on the impeller vane outlet
velocity triangle calculation, which is influenced by head and capacity co-efficient
selection. This determines the blade discharge angle and absolute fluid velocity
leaving the impeller. Inlet vane angles are also selected to minimise the degree of
pre-whirl. Finally, the impeller profile is completed by designing the transition from
inlet to outlet vane angle whilst maintaining an acceptable diffusion ratio so as not to
induce separation.
The volute casing design is then undertaken using parameters generated from the
impeller design procedure. In particular, throat velocity and thus area is determined
from the absolute discharge velocity, while the volute angle of spiral is selected to
match the angle of this fluid velocity leaving the impeller. The volute design is
continued by selecting an appropriate width and cross section, before completing the
design by creating the single, double or circular volute profile.
The entire centrifugal pump design is then completed by creating the flat inlet volute.

4-33
4.3.1 Design Conditions and Fluid Properties
The following tables describe the fluid properties (Table 4-1), the design conditions
of pressure (Table 4-2), and flow rate (Table 4-3) required of each assist application.
Table 4-1 Fluid Properties
Table 4-2 Design Output Pressure
LVAD Bi-LVAD Bi-VAD
Left Right Left Right
mmHg 100 100 100 100 20
KPa 13.33 13.33 13.33 13.33 2.67
meters
[Blood]
1.29 1.29 1.29 1.29 0.26
Feet
[Blood]
4.23 4.23 4.23 4.23 0.85
Table 4-3 - Design Flow Rates
LVAD Bi-LVAD Bi-VAD
L/min 5 2.5 2.5 5 5
m
3
/sec 8.33E-05 4.17E-05 4.17E-05 8.33E-05 8.33E-05
GPM 1.32 0.66 0.66 1.32 1.32
ft
3
/s 2.94E-03 1.47E-03 1.47E-03 2.94E-03 2.94E-03

As identified in Chapter 3, average systemic and pulmonary pressures of 93mmHg
and 15mmHg respectively are required to overcome normal systemic and pulmonary
vascular resistances, and ensure sufficient organ and tissue perfusion of 5L/min.
However, continuous flow blood perfusion results in vasoconstriction, which
increases vascular resistance. To ensure the pump has sufficient capacity to deliver
the required flow, slightly larger values of 100mmHg and 20mmHg were selected as
the design operating points.
Due to the energy contribution of the failing heart, the pump may not always be
required to deliver exactly these conditions. However, the contribution of the device
is impossible to predict for each individual patient. Furthermore, the pump will
actually operate about these specified conditions during systole and diastole,
effectively averaging the output to deliver these requirements.
Water Blood
Density () 1000 kg/m
3
1056 kg/m
3

Viscosity () 1.15x10-3 Pas 4x10-3 Pas
Kinematic Viscosity () 1.15x10-6 Pas 3.8x10-6 Pas
4-34
Design parameters are presented for three pump configurations. The LVAD and Bi-
LVAD configurations are for the left ventricular support condition, and thus require
an output pressure of 100mmHg. The former is a single sided impeller device, which
therefore requires all 5L/min of flow to pass through the impeller vanes. The latter
configuration is a double sided impeller device, which requires the entire 5L/min of
flow to be diverted between each set of impeller vanes. The final configuration
attempts to address bi-ventricular support with a double sided impeller. The left side
of the impeller must deliver the systemic circulation hemodynamics, and is identical
to the single sided LVAD support condition. The right side however, must deliver the
hemodynamic conditions required of the pulmonary circulation. Since both
chambers of the device are effectively operating in series, the entire 5L/min of flow
must pass through each set of impeller vanes.
4.3.2 Pump Constants from Similitude
The following parameters are most important for centrifugal pump design, and are
used to compare the relative performance of all centrifugal pumps.
Reynolds Number (Re)
The Reynolds number is a dimensionless parameter used to relate viscosity, impeller
rotational speed and diameter (Equation [ 4-1 ]). The Reynolds number is used to
ascertain a laminar or turbulent regime, with the transition occurring around 1.0e
5
for
pumps. TheRe for each VAD is given in Table 4-4.
4
Re
2
D
=

[ 4-1 ]
Table 4-4 Reynolds Number (Re)
LVAD Bi-LVAD Bi-VAD
L and R Left Right
Re 3.3 e
4
3.3 e
4
3.3 e
4
6.6 e
3

Specific Speed (N
s
)
The specific speed (N
s
) or type number of a centrifugal pump is a dimensionless
number that describes the relationship of pump speed, capacity and head (Equation [
4-2 ]). Specific speed (Table 4-5) may be described using imperial or metric scales.
4-35
4
3
2
1
.
H
Q N
N
s
= [ 4-2 ]
Table 4-5 Specific Speed (N
s
)
LVAD Bi-LVAD Bi-VAD
L and R Left Right
n
s(US Units)
750 530 750 2507
n
s(Metric Units)
0.2744 0.20 0.2744 0.916

Specific Capacity (q
s
)
The specific capacity (q
s
) is defined as the volume rate of fluid (Q[ft
3
/s(m
3
/s)] ) per
unit rotational speed (n[rad/s]) with a unit outlet radius (r
2
[ft(m)]), and remains
constant for similar impellers (Equation [ 4-3 ]). Values are displayed in Table 4-6.
3
nr
Q
q
s
= [ 4-3 ]
Table 4-6 Specific Capacity (q
s
)
LVAD Bi-LVAD Bi-VAD
L and R Left Right
q
s
0.0264 0. 0264 0.0264 0.298

Specific Head (h
s
)
The specific head (h
s
) is defined as the input energy per unit mass
(g[ft/sec
2
](m/s
2
),H[ft](m)) per revolution (n[rad/s]) and with an impeller of unit
diameter (D[ft](m)). It again remains constant for similar impellers (Equation [ 4-4 ])
with values for each VAD given in Table 4-7.
2 2
r n
gH
h
s
= [ 4-4 ]
Table 4-7 Specific Head (h
s
)
LVAD Bi-LVAD Bi-VAD
L and R Left Right
h
s
0.51 0.51 0.51 0.504

4-36
4.4 Design Detail
A number of pump impeller and volute configurations were designed for each left,
right and bi-ventricular assist application, for the purpose of assessing hydraulic
performance and impeller force characteristics. The following section discusses the
details of these configurations.
Each design was guided by the customised procedure outlined in Appendix B, which
also details the design parameters and all impeller/volute geometries. Future
iterations are recommended to best match the design with the constraints demanded
from the blood pump application.
4.4.1 LVAD
A single sided LVAD was designed primarily as a control for performance and
impeller force characteristic comparison with each subsequent VAD design. This
particularly involved the examination of the effect of exit blade angle on the
performance curve, and the variation of impeller hydraulic forces within each volute
configuration.
Table 4-8 describes the variety of impeller and volute configurations used in the
LVAD experiments. Each volute tested with the backward and radial blades were
designed with respect to those impellers. However, the forward facing impeller was
tested with the volute designed for the backward facing blade impeller, since no
design parameters were available for the design of a single volute incorporating a
forward facing impeller.
Table 4-8 LVAD Impeller and Volute Configurations
Impeller Volute
22.5 Backward Facing Single
Double
90 Radial Circular
Single
112.5 Forward Facing Single

Isometric and cross-sectional views of an LVAD pump configuration modified to
allow for appropriate testing procedures are shown in Figure 4-18.
4-37

(a) Isometric View (b) Cross Sectional View
Figure 4-18 LVAD Pump
4.4.2 RVAD
A single sided RVAD was designed to provide the ability to test the independent
operation of RVAD impeller and volute designs.
The aim of this design was to determine the pump performance within the various
volute configurations.
Table 4-9 describes the impeller configuration designed for single RVAD testing,
with corresponding volute configurations.
Table 4-9 RVAD Impeller and Volute Configurations
Impeller Volute
Circular

Isometric and cross-sectional views of a RVAD pump configuration modified to

Figure 4-19 RVAD Pump
4-38
4.4.3 Bi-LVAD
The double suction Bi-LVAD was designed for the purpose of performance
characteristic and impeller force distribution comparison to the conventional single
sided LVAD.
The aim of this design was to assess the change in performance characteristics as
well as impeller force distribution, particularly in the axial direction.
Table 4-10 describes the impeller and volute configuration designed for Bi-LVAD
testing.
Table 4-10 Bi-LVAD Impeller and Volute Configurations
Impeller Volute

Isometric and cross-sectional views of a Bi-LVAD pump configuration modified to

Figure 4-20 Bi-LVAD Pump

4-39
4.4.4 Bi-VAD
The Bi-VAD pump design is a combination of LVAD and RVAD pump designs
joined in a single device. As such, the design parameters for each side of the device
are identical to those for the LVAD and RVAD case.
The aim of this design was to determine the combined effect of LVAD and RVAD
configurations on performance characteristics in the Bi-VAD setting.
Table 4-11 describes the variety of impeller configurations designed for the Bi-VAD
application, with corresponding volute configurations.
Figure 4-21 illustrates the Isometric and cross-sectional views of a Bi-VAD pump
configuration modified to allow for appropriate testing procedures.

Figure 4-21 Bi-VAD Pump

Table 4-11 Bi-VAD Impeller and Volute Configurations
Impeller Volute
22.5 Backward Facing 22.5 Backward Facing Single Single
90 Radial Circular Circular

4-40
4.5 Discussion
The customised centrifugal pump design procedure combined many author
recommendations relevant to the cardiac support device application. The generated
MATLAB code improved the design task by efficiently calculating parameters for
impeller and volute construction.
Specific speeds (N
s
) of 750 and 2507 were determined for the LVAD and RVAD
applications respectively, based on impeller diameters of 50mm and 22.3mm, and a
common rotational speed of 1921 rpm.
Each impeller incorporated six vanes in a semi-open or closed shroud configuration.
Vane angles of 22.5 (backward), 90 (radial) and 112.5 (forward) were designed
for evaluation in single, double and circular volute configurations. Although
parameters for the radial impeller were selected for 90, the actual discharge angle
was 78. This was due to the incorporation of a correct inlet angle (to reduce pre-
swirl) and maintenance of straight radial vanes. Parameters for the 112.5 were
interpolated from relevant graphs, as this discharge angle is not accounted for in
conventional pump design.
The double volute was a splitter type, while the base circle of the circular volutes
was 1.15 times the impeller diameter. Each volute, designed for constant fluid
velocity, incorporated a rectangular cross section with filleted edges. The width of
this cross section was maintained according to recommendations, along with a
matched volute throat area to each impeller. This resulted in a mismatch of volute
spiral angle and absolute impeller discharge angle, but was assumed negligible due to
the low specific speed. Finally, an inlet volute was designed for improved anatomical
compatibility, while the outlet diffuser angles were maintained below 13.

4-41
4.6 Conclusion
The customized centrifugal pump design procedure facilitates the efficient and
timely design of VAD iterations. Incorporating the procedure into MATLAB code
enables the ability to easily vary the design requirements to produce a set of
parameters that influence impeller/volute development.
The procedure was used to design the double suction Bi-LVAD pump, as well as
single suction LVAD and RVAD pumps. These latter designs couple to form the Bi-
VAD pump, and were constructed to independently test various impeller and volute
configurations in each assist application.
Since the Bi-LVAD device requires identical pressure from each outlet, the vanes of
the double impeller are symmetrical in nature. To produce the variation in pressure
required from each output of the Bi-VAD device, the impeller vane diameters of
each side are different in length, as dictated by the LVAD an RVAD designs.

Chapter 5 - VAD Experimental Evaluation
5-1
Chapter 5
VAD Experimental Evaluation

The experimental evaluation of the VAD hydraulic designs presented in chapter 4
specifically investigates the effect of impeller (semi-open/closed) and volute (single,
double, circular) components for each ventricular assist application. This was
conducted within a unique test facility, to assess performance and isolate impeller
hydraulic forces while inserted into the complete mock circulation loop (Chapter 3)
configured for non-pulsatile and pulsatile operation.
The results presented in this chapter are used to recommend appropriate impeller /
volute configurations for designs incorporating magnetic, hydrodynamic and
mechanical bearings, to minimise impeller touchdown and increase device lifetime.
5.1 Introduction
The performance characteristics of a new prototype VAD are generally tested by
setting pump rotational speed and varying circuit resistance in a non-pulsatile
circulation loop (Tansley, Vidakovic et al. 2000; Masuzawa, Ezoe et al. 2003).
However, VAD performance also includes the ability of the device to assist a failing
heart to maintain sufficient cardiac output and native physiological pressures
(Koenig, Pantalos et al. 2004). For accurate testing, prototype pumps should be
subsequently inserted into a pulsatile circulation system, such as the in-vitro pulsatile
mock circulation loop presented in Chapter 3, or an in-vivo animal model.
Previous investigations into rotary blood pump forces are limited in number.
Experimentally unverified CFD models were used to evaluate forces at a single, non-
pulsatile operating point (Qian and Bertram 2000), thus effectively neglecting failing
heart pulsatility. Magnetic coupling techniques have been used to determine impeller
axial forces only (Takami, Makinouchi et al. 1997) while magnetic bearings were
calibrated to determine radial force (Allaire, Kim et al. 1996). Therefore, a unique
method was required to measure the magnitude and direction of impeller hydraulic
thrust during non-pulsatile and pulsatile device operation.
5-2

Figure 5-1 Experimental Process Diagram

Refer Figure 5-2
5-3
The purpose of this investigation was to assess the performance (Characteristic and
Hemodynamic) of the hydraulically designed impeller/volute configurations
presented in Chapter 4, while recording static hydraulic force magnitude and
direction. The effect of impeller exit blade angle and variation of axial clearance gap
on characteristic hydraulic performance was investigated. The LVAD configuration
was inserted into the mock circulation loop configured for left heart failure, and its
ability to reduce pulmonary congestion and restore perfusion levels from
pathological to normal levels is demonstrated. The influence of failing heart
pulsatility on the magnitude and direction of hydraulic forces is therefore established,
by comparing these results to those obtained during non-pulsatile operation.
The results initially aid the selection of the best impeller/volute configuration for the
magnetically suspended Bi-LVAD and Bi-VAD designs. However, the results may
be also applied to VAD designs incorporating hydrodynamic and mechanical type
bearings. The incidence of impeller touchdown can then be minimised by
accommodating sufficient bearing load capacity to counter the force magnitudes.
5.2 Experimental Method
The following overview of the experimental configuration, used to record pump
performance and force data under non-pulsatile and pulsatile conditions, makes
reference to the process diagram displayed in Figure 5-1.
The experiments were undertaken with software and hardware installed on a 700
MHz Celeron PC running Windows 98.
The operation and capture of mock loop and VAD performance results was
undertaken with CONTROLDESK software. The systemic and pulmonary vascular
resistances, heart rate and period in systole were determined in this environment for
mock loop operation, while a value for VAD rotational speed was also set. This
information was passed to the SIMULINK model. This model incorporated blocks
for all aspects of the real mock circulation loop and VAD system. Before the
commencement of the experiment, this model was uploaded to the dSPACE card
using Real-time Workshop Build (RTW) and the Target Language Compiler (TLC).
This process provided the ability to create a link between the CONTROLDESK
interface and the experimental rig through the MATLAB Real Time Interface
toolbox. Signals could now pass in real-time from CONTROLDESK to the dSPACE
5-4
card through the MATLAB based SIMULINK model and RTI MATLAB toolbox.
An interface box transmitted the SVR, PVR, HR, Percent in Systole (%sys) and
motor speed signals from the dSPACE card to the mock circulation rig and VAD
respectively. These signals commenced and dictated the experiment operation. SVR
and PVR signals determined the actuation of the proportional control valves, each
supplied with 12VDC/2A power. HR and %Sys signals respectively controlled the
rate and period of actuation of the solenoid valves, each supplied with 24VDC
power. The RPM set signal fluctuated between the dSPACE restricted 0-10V
depending on the desired set motor speed. The signal was input into a custom 2.4
gain voltage amplifier, supplied with +/- 26VDC power, to amplify the signal to the
0-24V range of the motor.
Experimental performance was evaluated using pressure transducers and flow
meters, supplied with +12VDC supply and 240V supply respectively. The
instrumentation produced a voltage signal that indicated the actual value, which was
passed to the dSPACE card via the interface box. Voltage signals from the motor
encoder and amplifier were also returned to indicate motor speed and current, with
the latter signal calibrated to return 100mV per amp. These signals returned to the
CONTROLDESK interface through RTI, MATLAB and SIMULINK model, for
real-time capture and monitor display.
Code was written and executed in MATLAB simultaneously with the performance
parameters for the capture of impeller force data. The code utilised the MATJ R3.dll
driver to communicate with the J R3 force transducer via the J R3 DSP ISA card. This
card receives voltage and current signals from the force transducer and resolves them
into force or moment values for each degree of freedom. This data is then available
for software recording/manipulation in the form of a 6x1 matrix.
5.2.1 Prototype Pump Construction
Each prototype pump (impeller and volute) was constructed using a rapid prototype
manufacturing process. The various configurations were drawn in CAD software
(Solidworks
TM
) and exported as STL files. These files had a chord angle of 3 degrees
and tolerance of 0.01mm. The STL files were sent to a rapid prototyping facility
(Concentric Asia Pacific, Brisbane, Australia) for manufacture using the stereo-
lithography process.
5-5
This process created each part from an epoxy based resin. Each piece was then post
processed by bead blasting and sanding all surfaces prior to assembly in the testing
facility. The testing facility, described in more detail later, was designed to
accommodate each modular pump component for subsequent hydraulic performance
and force testing.
5.2.2 Equipment / Instrumentation / Software / Code
Equipment / Instrumentation
JR3
Impeller hydraulic force data acquisition was achieved using the J R3 50M31 A-125
100N5 force transducer (J R3, California, USA). This force transducer has the ability
to resolve forces and moments in all six degrees of freedom at any one time. The
maximum measurable load in the axial (z) and radial (x,y) directions were 200N and
100N respectively. The maximum moment about all axes is 5Nm. The transducer
was manufactured 20/03/1997 and was recalibrated on 31/12/2003.
Pinch Valves
Proportional control valves (ECPV-375B, HASS Manufacturing, USA) were used to
control pump afterload resistance. The valves were powered with a 12VDC/2A
supply and proportionally responded to a 5VDC signal produced from two dSPACE
card DAC channels. The valves had the additional ability to alter actuation rate by
altering onboard electronic jumper configuration.
The jumpers were configured at the slowest rate of actuation (approx 30seconds open
to closed). Furthermore, the rate of control input voltage signal was set by the
SIMULINK model to reduce the actuation time to approx 120 seconds. This code
was implemented to automate the capture of non-pulsatile performance
characteristics.
DSPACE
The mock loop and assist device were simultaneously controlled by a digital signal
processing (DSP) controller board. The card was a 250 MHz model DS1104
(dSPACE, MI, USA) that incorporated a combined total of eight ADC (4x16bit,
4x12bit) and eight DAC (8x16bit) channels, 20 bit digital I/O, and two digital
incremental encoder interfaces (TTL compatible).
5-6
Motor
The VAD iterations were driven by a conventional DC motor AMAX32, Maxon
Motor, Switzerland). A 0-10V signal representing the set rotational speed was
determined from the SIMULINK speed controller and output from the dSPACE card.
This signal was amplified with a gain of 2.4 V/V to achieve the full 0 - 24 V range of
the motor. The actual motor speed was recorded with the integrated encoder, and fed
back to the speed controller via the dSPACE card.
Software / Code
MATLAB
Custom code was written in MATLAB (J r3.m). The code interfaced with the J R3
transducer via the MATJ R3.dll driver, developed by J . Norberto Pires. This enabled
the real-time capture of force and torque data for future analysis. The code and full
description of its operation is provided in APPENDIX D.
SIMULINK Model
A model was created in SIMULINK to provide a link between the experimental test
rig and the CONTROLDESK interface. This model replicated the components of the
experimental system, and incorporated parameters for real-time variation from
CONTROLDESK. A full description of the model is provided in APPENDIX D.
The model controls the operation of the mock circulation rig independent of VAD
status. The model also incorporates subsystems that dictate VAD operation.
VAD Subsystem
A subsystem within the model records the performance and controls the operation of
the inserted VAD. This subsystem is responsible for recording and maintaining
rotational speed, recording motor power and determining pump efficiency.
CONTROLDESK
An interface program was developed in CONTROLDESK for the real-time capture
and manipulation of relevant parameters. Mock circulation loop operation was
determined, before pump rotational speed was decided and maintained. A splash
screen of the CONTROLDESK interface is provided in APPENDIX D.
5-7
5.2.3 Experimental Design
Evaluation of LVAD performance and impeller hydraulic force was conducted in-
vitro using the pulsatile mock circulation loop presented in Chapter 3. The loop
initially operated in a non-pulsatile configuration to identify pump performance
curves and non-pulsatile hydraulic forces over the entire flow capacity range. It was
then configured to replicate a degree of untreated left heart failure, before the LVAD
was introduced to assess its ability to re-establish hemodynamic parameters from
pathological to normal levels. The impact of failing heart function on hydraulic
forces was simultaneously evaluated.
Hydraulic Force and Performance Measurement
Each LVAD impeller was supported by a shaft, seal and contact bearing system.
Rotation was provided by a 20W motor and monitored with a digital encoder
(AMAX32 / HEDS 55__, Maxon Motor, Switzerland). The shaft, bearing and motor
assembly (grey) was separated from the pump casing (black) by a multidimensional
force transducer (50M31, JR3 Inc, USA) and two flexible couplings (Figure 5-2).
The hydraulic forces imposed on the impeller were transferred through the shaft and
resisted by the force transducer. The transducer exhibited high displacement
stiffness, preventing impeller movement within the pump cavity. To eliminate fluid
momentum effects on the shaft at the pump inlet eye, a metallic sleeve protruded
from the centre of the inlet volute.
Modular pump components enabled the interchangeable testing of all volute types for
each impeller type. Another single volute was created with ten pressure ports, which
were connected to pressure transducers for measuring volute pressures around the
impeller (Figure 5-3).
5-8

Figure 5-2 Force Test Rig

5-9

0
90
180
270
5
4
3
2
1
7
6
10
8
9

Figure 5-3 Pressure Tapping Locations

These pressure readings were integrated to reveal static radial forces at three flow
capacities (Shut-off, design, max flow). Performance and force data were
automatically gathered in real-time by interfacing signals to a PC using a dSPACE
controller board (DS1104, dSPACE, MI, USA) and J R3 inc. acquisition card. This
enabled the use of SIMULINK and CONTROLDESK for implementation of custom
control and acquisition code. Afterload vascular resistance was controlled with a
proportional control pinch valve (HASS Manufacturing, USA). Pressure and flow
rates were monitored with TOYODA pressure transducers (SD10B-1, Gambro, USA)
and 10mm ID electromagnetic flow meters (IFC010, KROHNE, Sweden).
5.2.4 Experimental Procedure
Non-Pulsatile Condition
Real-time performance and force data were recorded in the non-pulsatile mock loop
configuration at a constant pump speed while varying afterload resistance
Pump speed set in CONTROLDESK was maintained using a SIMULINK coded
speed controller, using feedback from the digital encoder. The proportional control
5-10
pinch valve was controlled to slowly open from shut-off, to automatically vary
afterload resistance while capturing pressure and flow signals in CONTROLDESK.
Radial (x,y) force, axial (z) force, and torque (Mz) data were simultaneously
recorded using custom MATLAB code interfacing to the J R3 force transducer via the
J R3 acquisition card. Impeller weight and dynamic unbalance were offset prior to
insertion in the mock loop.
Motor input power was recorded throughout the duration of each test, and divided by
the motor efficiency to reveal the total electrical input power (P
in
=Volts x Amps /
M
eff
) supplied to each pump. The total hydraulic output power (P
out
=pgHQ +c
2
/2g)
was derived from the recorded pressure and flow rate values. By dividing the output
power by the input power, a value of overall pump efficiency was revealed.
After completing initial tests, the effect on performance of axial impeller actuation
within the pumping cavity was investigated. The single volute, semi-open impeller
(112) LVAD configuration was inserted into the non-pulsatile loop, and operated at
2600 rpm with the impeller in the central position (middle). The circuit resistance
was then tuned to provide a constant 100mmHg afterload on the device. With the
use of 0.5mm spacers, the impeller was then moved axially relative to the casing
until the axial clearance above the vanes was minimal (top). Resistance was tuned
and complete performance curve results were recorded for the new position. Spacers
were used to increase the axial clearance in 0.5mm increments, each time recording
results, until a maximum clearance gap was observed (bottom). The pump speed and
afterload resistance were again controlled while the impeller was moved from bottom
to top location. The changes in flow rate were recorded in real-time. Finally, results
were also obtained for pump operation at 2400rpm at top, middle and bottom
impeller locations.
Pulsatile Heart Failure Condition
Failing heart function was initiated in the mock circulation loop, as described in
Chapter 3. The single volute, closed impeller type design was then introduced to
assess its ability to re-establish normal hemodynamic parameters. The impact of
failing heart function on hydraulic forces was simultaneously evaluated.
5-11
5.2.5 Calibration
Equipment and instrumentation was calibrated prior to testing. A brief description of
this process follows, with the results from the calibration tests provided in
APPENDIX E.
Electric Motor
To determine the actual input electrical power, the power required to overcome the
bearing resistances must be taken away from the total measured value. The pump
was run dry from 200 to 3000 rpm before each experiment, with values of Volts and
Amps recorded. The electrical power (V x A) was then multiplied by the maximum
motor efficiency (motor constant) (77%) to determine the power required to
overcome bearing resistance. The power was assumed to increase linearly with
respect to speed and therefore an equation was established that enabled the
appropriate no load power values to be subtracted from power readings recorded
from the pending experiments.
JR3 Force Transducer
The small range of recorded radial and axial hydraulic force presents a limitation due
to the transducer full scale range (100 N). The 14 bit resolution of 6 mN was
adequate for static force measurements, however, poor sensitivity meant a less than
ideal signal to noise ratio, preventing the investigation of high frequency dynamic
forces (up to 1 kHz). The influence of noise on the static force readings was removed
by digitally filtering the transducer signals to produce time averaged values.
To ascertain the actual values of force in each degree of freedom, unbalance forces
produced while operating the pump dry should be subtracted from the values
measured during wet operation. Therefore, the pump was run dry at speeds ranging
from 200 to 3000 rpm with values of force in each degree of freedom recorded.
Pressure Transducers
Each pressure transducer was calibrated before use. The voltage signal for
atmospheric pressure was recorded before a known pressure was exposed to each
transducer. The difference in pressure was divided by the change in voltage signal to
calculate the individual transducer gain (mmHg/Volt). The gains were then altered
to common values (770mmHg/V or 385mmHg/V) for simplicity.
5-12

(a) LVAD (b) RVAD
(c) Bi-VAD Side
Figure 5-4 Experimental VAD configurations
5-13
5.2.6 Experimental Configurations
The LVAD (Figure 5-4(a)) configurations were inserted into the complete mock
circulation rig to assess performance characteristics and hydraulic forces. Not every
configuration was tested for force and performance data in non-pulsatile and pulsatile
modes. Table 5-1 cross-references the volute and impeller types, with the legend
indicating the tested conditions.
Table 5-1 LVAD Impeller/Volute Experimental Configurations
Impeller Discharge Angle (
2
)
Volute Type 22.5 112.5
Single
Double
Circular
P,N,F
N,F
N,F
N
x
x
P Pulsatile Performance, N Non-Pulsatile Performance, F - Forces Recorded, x - Not tested
A single RVAD (Figure 5-4(b)) was inserted into the loop to evaluate the designs
hydraulic performance characteristics in the non-pulsatile loop only, for the
configurations described in Table 5-2. No impeller forces were recorded.
Table 5-2 RVAD Impeller/Volute Experimental Configurations
2
)
Volute Type 22.5 112.5
Single
Double
Circular
N
x
N
x
x
x
N Non-Pulsatile Performance, x - Not tested
The impact of Bi-VAD insertion (Figure 5-4(c)) on the hemodynamics of simulated
left and right heart failure (pulsatile) conditions was qualitatively assessed for
configuration B (Table 5-3). Again, no impeller forces were recorded.
Table 5-3 BVAD Impeller/Volute Experimental Configurations
LEFT Right
Impeller Discharge Angle (b
2
) Impeller Discharge Angle (
2
)
Volute Type 22.5 122.5 22.5 112.5
Single
Double
Circular
(A) x
x
x
x
x
(B) P
(A) x
-
(B) P
x
x
x
(A) Pump Configuration 1, (B) Pump Configuration 2, P Pulsatile Performance, x - Not tested
The current iteration Bi-LVAD was not tested, however the performance and force
data from a previous iteration was recorded and presented in (Timms, Tan et al.
2004).
5-14
0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Single Volute Performance Characteristics (22.5)
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0 2 4 6 8 10
0
10
20
30
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
Single Volute Efficiency (22.5)
2700Rpm
2400Rpm
2100Rpm
1800Rpm

(Single Volute, 22.5
o
)
0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0 2 4 6 8 10
0
10
20
30
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
2700Rpm
2400Rpm
2100Rpm
1800Rpm

o
)
0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Double Volute Performance Characteristics
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0 2 4 6 8 10
0
10
20
30
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)

Double Volute Efficiency
2700Rpm
2400Rpm
2100Rpm
1800Rpm

(Double Volute, 22.5
o
)
0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Circular Volute Performance Characteristics
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0 2 4 6 8 10
0
10
20
30
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
Circular Volute Efficiency
2700Rpm
2400Rpm
2100Rpm
1800Rpm

(Circular Volute, 22.5
o
)

Figure 5-5 LVAD Family of Pump Performance and Efficiency Curves
5-15
5.3 Results
5.3.1 Non-Pulsatile
Hydraulic Performance
LVAD
Performance Characteristics
The pump characteristic and stage efficiency curves for each of the LVAD
configurations inserted into the non-pulsatile loop are displayed in Figure 5-5. The
rotational speed required to achieve design conditions depended on the
impeller/volute configuration (Table 5-4).
Table 5-4 - Design Point Rotational Speed (RPM) of LVAD Impeller/Volute Configurations
2
)
Volute Type 22.5
o
112.5
o

Single
Double
Circular
2400 RPM
2475 RPM
2450 RPM
2550 RPM
x
x

The single volute (22.5) configuration (where the bracketed number corresponds to
the discharge angle) featured the lowest rotational speed and consequently the
highest best efficiency. A slight increase in rotational speed and corresponding
decrease in maximum efficiency was observed for the double volute (22.5), circular
(22.5) and single volute (112.5) configurations respectively.
All pump curves were relatively flat below design point. All curves, except the single
volute (112), tapered down significantly above the design point. Instead, the single
volute (112) configuration maintained a relatively flat response, as anticipated for
pumps employing forward facing vanes.
The double volute (22.5) configuration could not attain the same level of best
efficiency as the single volute (22.5). However efficiencys at off design flow rates
were higher. Single volute (112) performance exhibited the least efficiency at design
conditions.
Results for the single volute (90) configuration are not presented due to poor
performance. This was attributed to excessive shroud blockage due to a small
impeller vane height, and will be discussed in further detail later in the chapter.
5-16
Variation of Axial Clearance
The effect on performance of axial clearance variation (between the vanes and top
casing) of the semi-open (112) impeller is presented in Figure 5-6. It is observed
that efficiency and thus hydraulic performance over all capacities is best when axial
clearance is minimised (0.1mm). As clearance is then increased, a corresponding
decrease in efficiency and performance is observed until the clearance is maximised
(2.5mm).
Maintaining pump speed (2600 rpm) and afterload resistance (100mmHg) while
actuating the impeller axially, produced flow rates and efficiencies contained within
the limits specified by the performance characteristic curves.
Flow rate was therefore observed to range between 4.8 6.1 L/min despite the pump
operating against a constant afterload and rotational speed.
0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
2600 RPM Performance (Axial Clearance 0.1-2.5mm)
0.1mm
0.5mm
1.0mm
1.5mm
2.0mm
2.5mm

0 2 4 6 8 10
0
5
10
15
20
25
30
35
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
2600 RPM Efficiency (Axial Clearance 0.1-2.5mm)
0.1mm
0.5mm
1.0mm
1.5mm
2.0mm
2.5mm

(a) Performance (left) and efficiency (right) at constant speed and variable afterload

0 2 4 6 8 10
0
50
100
150
200
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
2600 Rpm

0 2 4 6 8 10
0
10
20
30
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
2600Rpm

(b) Performance (left) and efficiency (right) at constant 2600rpm and 100mmHg afterload

Figure 5-6 LVAD Performance with Constant Speed and Axial Clearance Variation

5-17
Non-Dimensional Parameters
Specific head (h
s
) was plotted against specific capacity (q
s
) for direct comparison of
each configurations hydraulic performance (Figure 5-7). This graph is non-
dimensional, therefore each family of performance curves are grouped into a single
non-dimensional curve.
0 0.005 0.01 0.015 0.02 0.025 0.03 0.035
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Flow Coefficient qs
H
e
a
d

C
o
e
f
f
i
c
i
e
n
t

Non-Dimensional Performance Characteristics
Single Volute (
22.5
)
Single Volute (
112.5
)
Double Volute (
22.5
)
Circular Volute (
22.5
)

Figure 5-7 LVAD Non-Dimensional Pump Performance Curves

Maximum capacity is achieved in both single volute (22.5 & 112.5) configurations,
with the latter exhibiting a flatter characteristic curve, albeit at lower specific head.
Both circular and double volute maximum specific capacity is limited, while the
former exhibits greatest specific head at shutoff. The specific head at shut-off of
each backward blade configuration ranged between 0.5 and 0.6.
Specific Power was also calculated and plotted against specific capacity. This non-
dimensional graph (Figure 5-8) is used to compare the power requirements of the
various pump configurations. Due to difficulties in obtaining exact input power
measurements, the graph is presented to outline the qualitative effect of power trends
for each volute configuration. For instance, all configurations incorporating
5-18
backward swept discharge blade angles exhibited a decreasing power gradient with
increasing capacity. The forward facing blade angle configuration however,
produced a slightly increasing power gradient. Furthermore, although the power
value accuracy is questionable, the results indicate the presence of a power
requirement due to recirculation at shut-off conditions.
0 0.005 0.01 0.015 0.02 0.025 0.03 0.035
0.02
0.025
0.03
0.035
0.04
0.045
0.05
Specific Capacity (qs)
S
p
e
c
i
f
i
c

P
o
w
e
r

(
P
s
)
Specific Power (Ps) Vs Specific Capacity (qs)
Single Volute (
22.5
)
Single Volute (
112.5
)
Double Volute (
22.5
)
Circular Volute (
22.5
)

Figure 5-8 LVAD Non-Dimensional Power Curves

5-19
RVAD
The family of performance curves and non-dimensional graph for each RVAD
configuration are presented in Figure 5-9 and Figure 5-10 respectively.
0 1 2 3 4 5 6
0
5
10
15
20
25
30
35
40
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Single Volute Performance Characteristics
3000Rpm
2700Rpm
2400Rpm
2100Rpm
1800Rpm

0 1 2 3 4 5 6
0
5
10
15
20
25
30
35
40
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Circular Volute Performance Characteristics
3000Rpm
2400Rpm
2100Rpm
1800Rpm

o
) (Circular Volute, 22.5
o
)
Figure 5-9 RVAD Family of Pump Performance Curves
0 0.05 0.1 0.15 0.2 0.25 0.3
0
0.1
0.2
0.3
0.4
0.5
0.6
Specific Capacity
S
p
e
c
i
f
i
c

H
e
a
d

Specific Head (hs) Vs Specific Capacity (qs)

Single Volute (
22.5
)
Circular Volute (
22.5
)
Figure 5-10 RVAD Non-dimensional Pump Performance Curves

5-20
The results characterise the poor performance of each configuration, with the design
condition met at rotational speeds well above the theoretical speed of 1921rpm
(Table 5-5).
Table 5-5 - Design Point Rotational Speed (RPM) of RVAD Impeller/Volute Configurations
2
)
Volute Type 22.5
Single
Circular
3000 RPM
3800 RPM

The non-dimensional analysis also confirms this performance, with a common
maximum specific head at shut-off of 0.4, and maximum flow coefficients of 0.14
and 0.19 for the circular and single volutes respectively.
This poor performance was attributed to flow blockage by the 6 impeller vanes.
Furthermore, the inlet swirl effect of the inlet volute was not considered, and could
contribute to a reduction in useful output head.
Considerable scattering was observed in the characteristic RVAD curves, which is
not consistent with conventional pump operation. This scattering could be a result of
the automated method of pressure and flow recording. The variation of outlet
resistance was not smooth, as the pinch valve steps its position from close to open.
After each step, pressure immediately drops while the inertiance of the flow
contributes to the slower response to increase flow rate. Since both pressure and flow
are recorded in real-time, these variations are captured as scatter.

5-21
Hydraulic Force
Static Radial Force
Static radial force magnitudes and directions are displayed in Figure 5-11 for each
volute type.
0 2 4 6 8 10
0
0.2
0.4
0.6
FlowRate (L/min)
F
o
r
c
e

(
N
)
Single Volute Radial Thrust Magnitude
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0.25
0.5
30
210
60
240
90
270
120
300
150
330
180 0
Single Volute Radial Thrust Direction
Force X (N)
F
o
r
c
e

Y

(
N
)
Q<Qn
Q=Qn
Q>Qn
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

(a)i. Single Volute Magnitude (a)ii. Single Volute Direction

0 2 4 6 8
0
0.2
0.4
0.6
FlowRate (L/min)
F
o
r
c
e

(
N
)
Double Volute Radial Thrust Magnitude
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0.2
0.4
30
210
60
240
90
270
120
300
150
330
180 0
Double Volute Radial Thrust Direction
Force X (N)
F
o
r
c
e

Y

(
N
)
Q = 0
Q = Qn
Q > Qn
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

(b)i. Double Volute Magnitude (b)ii. Double Volute Direction

0 2 4 6 8 10
0
0.2
0.4
0.6
FlowRate (L/min)
F
o
r
c
e

(
N
)
Circular Volute Radial Thrust Magnititude
2400 Rpm
2100 Rpm
1800 Rpm

0.5
1
30
210
60
240
90
270
120
300
150
330
180 0
Circular Volute Radial Thrust Direction
Force X (N)
F
o
r
c
e

Y

(
N
)
Q<Qn
Q=Qn
Q>Qn
2400 Rpm
2100 Rpm
1800 Rpm

(c)i. Circular Volute Magnitude (c)ii. Circular Volute Direction

Figure 5-11 Radial Thrust in single (a), double (b) and circular (c) volutes.

0
90
180
270
0
90
180
270
0
90
180
5-22
Table 5-6 compares the radial thrust magnitudes at the design point
Table 5-6 Radial trust at design point (5L/min @ 100mmHg)
Volute Radial Force (N)
Single
Double
Circular
0.01
0.05
0.5

The trend of radial thrust versus non-pulsatile flow capacity follows that described
by theory. The single volute (Figure 5-11(a)i) experienced the smallest radial thrust
at the design point, followed by the double (Figure 5-11 (b)i) and circular volute
(Figure 5-11(c)i). The direction of the force vector depended on the pump
operating point in relation to the design point. For example, the force acted away
from the cutwater at below design conditions in the single volute, while it pointed
toward the cutwater above design (Figure 5-11(a)ii). This is explained by the degree
of fluid acceleration and thus velocity upstream of the cutwater. A similar trend is
found in the double volute, though at smaller magnitudes (Figure 5-11(b)ii). Radial
thrust was directed toward the cutwater of the circular volute at all capacities (Figure
5-11(c)ii).
Pressure Tappings
Integration of volute pressure was used to verify the transducer results. Operation of
the pump at 2400 rpm revealed a maximum force of 0.32N at shut-off, 0.05N at
design, and 0.27N at maximum capacity (Figure 5-12).
0.1
0.2
0.3
0.4
30
210
60
240
90
270
120
300
150
330
180 0
Radi al Force Di recti on and Magni tude at Vari ous Operati ng Condi ti ons
Force X (N)
F
o
r
c
e

Y

(
N
)
Q = 0
Q = Qn
Q > Qn

Figure 5-12 Radial Thrust Direction & Magnitude Integrated from Single Volute Pressures
Readings at Shut-off, Design and Maximum Flow Capacities.
5-23
Static Axial Force
The static axial forces encountered by the closed and open type impellers over all
non-pulsatile flow rates are presented in Figure 5-13.
0 2 4 6 8 10
0
2
4
6
8
FlowRate (L/min)
A
x
i
a
l

F
o
r
c
e

(
N
)
Closed Impeller Axial Thrust Magnitude
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

0 2 4 6 8 10
0
2
4
6
8
FlowRate (L/min)
A
x
i
a
l

F
o
r
c
e

(
N
)
Semi-Open Impeller Axial Thrust Magnitude
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

(a) Closed Impeller (b) Semi-Open Impeller

Figure 5-13 Axial Thrust on Impeller Types
Table 5-7 compares values of axial thrust at the design point. As expected, axial
thrust of the semi-open type impeller was larger in magnitude than the closed type
impeller.
Table 5-7 Axial thrust at design point

The technique of axial force balancing using a double entry impeller was evaluated
during the investigation of a previous iteration (Timms, Tan et al. 2004). Impeller
and pump geometry was therefore dissimilar to the current iterations presented.
However, the results indicated a reduction in axial force at design point from 7.55N
to 0.84N for single and double sided semi open impellers respectively (Figure 5-14).
Double Pump Axial Force

Figure 5-14 Comparison of Axial Thrust in a Semi-Open single and double impeller
(Timms, Tan et al. 2004)

Impeller Type Axial Force (N)
Closed
Semi-open
3
4.5
5-24
Reaction Torque
Values of reaction torque are displayed in Figure 5-15. The values are not absolute,
since an unknown transducer offset was eliminated by returning the value of torque
at shutoff capacity to zero. This is not entirely practical, as some torque and thus
power is required to recirculate the fluid at zero capacity. Instead, the result describes
the relative magnitudes of torque encountered at each rotational speed for the single
volute configuration. The resulting torque of 0.0075 Nm at design point is slightly
lower, but in the same order to that expected of a pump operating at the efficiencies
outlined previously.
0 2 4 6 8 10
-0.02
-0.015
-0.01
-0.005
0
Flow Rate (L/min)
Reaction Torque
2700 Rpm
2400 Rpm
2100 Rpm
1800 Rpm

Figure 5-15 Reaction Torque in Single Volute (22.5)

Comparison to Theory
The hydraulic performance characteristic results (pressure and flow) were used in the
equations proposed by each author (Appendix C) to predict radial and axial thrust
characteristics. Comparisons were then made to the recorded thrust values to
determine the most appropriate equation for thrust prediction in each impeller/volute
configuration.
Magnitude
Radial Thrust
Non-dimensional radial thrust factors for each volute type were calculated from
recorded values of radial thrust. These were compared to predictions made by each
author for similar pump operations (Figure 5-16).
5-25
0 20 40 60 80 100 120
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
Percent Capacity of B.E.P (%)
N
o
n
-
D
i
m
e
n
s
i
o
n
a
l

R
a
d
i
a
l

T
h
r
u
s
t

F
a
c
t
o
r

(
K
)
Comparison of Practical to Theoretical Radial Thrust Factors (K)
Single Volute
Double Volute
Circular Volute
Theory SV (KARASSIK)
Theory DV (ANSI)
Theory CV (STEPANOFF)

Figure 5-16 Comparison of measured Radial thrust with theoretical prediction

Good agreement was found between experimental single volute radial thrust factor
and that predicted by Karassik (2000). Estimation of double volute results was best
made using the method proposed in the ANSI (ANSI/HI 1994). Stepanoffs method
of calculating radial thrust (Stepanoff 1957) provided the most accurate comparison
to experimental circular volute results.
Axial Thrust
Axial thrust in the closed type impeller was found to be relatively independent of
volute type, aside from the influence on pressure development. Axial thrust
predictions made by Stepanoff (1957) described a similar trend to the experimented
results, however at a slightly lower magnitude (Figure 5-17).
5-26
0 20 40 60 80 100 120
0
1
2
3
4
5
Percent Capacity of B.E.P (%)
A
x
i
a
l

F
o
r
c
e

(
N
)
Comparison of Practical to Theoretical Axial Thrust
Single Volute
Double Volute
Circular Volute
All Volutes (Stepanoff)

Figure 5-17 Comparison of measured axial thrust with theoretical prediction

Direction
The directions of radial thrust experienced by the impeller operating from shut-off to
full capacity at 2400 rpm in the single, double and circular volutes are presented for
comparison in Figure 5-18. This figure illustrates the dependence of thrust direction
on the volute type employed.

0
90
180
270

Single
0
90
180
270

Double
0
90
180

0.5
1
30
210
60
240
90
270
120
300
150
330
180 0
Comparison of Radial Thrust Direction (2400 rpm)
Force X (N)
F
o
r
c
e

Y

(
N
)
Circular Volute
Double Volute
Single Volute

Circular
Figure 5-18 Direction of Radial Thrust in Single, Double and Circular Volutes at 2400rpm
Q<Q
n

Q>Q
n
Q<Q
n

Q>Q
n

Q=0
5-27
The single volute result was then compared to predictions of direction made by
(Agostinelli, Nobles et al. 1960) in Figure 5-19 at similar specific speeds to the
pump used in this study (Ns =740). The original figure (Figure 4-13) was re-oriented
to match the outlet geometry of the pump for the experimental results. That is, the
pump outlet directions were arranged to coincide with the same axis. Reasonable
correlation was found, with the experimental shut-off and full capacity directions
located in the predicted quadrants.

As expected, the direction of axial thrust was always toward the impeller inlet eye
(+Z), due to the imbalance of pressures acting on the impeller top and underside.
0
90
180
270
Ns=530
Ns=784
Q<Qn
Q>Qn

Figure 5-19 Radial thrust direction of comparative specific speeds in a single volute
5-28

0.8 1 1.2 1.4 1.6 1.8
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Untreated Heart Failure (Systemic)
LAP
LVP
AoP
MAP

0.8 1 1.2 1.4 1.6 1.8
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVAD Support (Systemic)
LAP
LVP
AoP
MAP

(i) Systemic Pressure Distribution (i) Systemic Pressure Distribution

0.8 1 1.2 1.4 1.6 1.8
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
Untreated Heart Failure (Pulmonary)
RAP
RVP
PAP
MPAP

0.8 1 1.2 1.4 1.6 1.8
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVAD Support (Pulmonary)
RAP
RVP
PAP
MPAP

(ii) Pulmonary Pressure Distribution (ii) Pulmonary Pressure Distribution

Figure 5-20 Untreated heart failure pressure
for systemic (i) and pulmonary (ii) circulation.
Figure 5-21 LVAD supported pressure for
systemic (i) and pulmonary (ii) circulation.

0 10 20 30 40 50 60 70 80 90 100
2
2.5
3
3.5
4
4.5
5
5.5
Time (sec)
P
e
r
f
u
s
i
o
n

R
a
t
e

(
L
/
m
i
n
)
Heart Failure Transition to LVAD Support (2200 rpm)
LVAD Insertion Point
LVAD Support
MSQ
SQ
MPQ
PQ

Figure 5-22 Transition of perfusion from Heart Failure to LVAD Support
5-29
5.3.2 Pulsatile
Left Heart Failure with LVAD Support
Individual systemic and pulmonary pressures and flow rates were measured in the
mock circulation loop during heart failure, and subsequent single volute LVAD
support, to determine the hemodynamic effect of VAD insertion.
Pressures
Simulated pathological blood pressures experienced in the heart failure condition
(Figure 5-20) were returned to acceptable levels with LVAD support (Figure 5-21)
in the (i) systemic and (ii) pulmonary circulatory systems. Detailed pressure values
are provided in Table 5-8. In particular, left atrial pressures were reduced from 25 to
8 mmHg, indicating the minimisation of pulmonary congestion. Mean aortic pressure
(MAP) was also improved. Left ventricular pressure (LVP) did not exceed the MAP
value during systole, suggesting the aortic valve remained closed. Finally, the aortic
pulse pressure was reduced, but not eliminated.
Table 5-8 Comparison of Heart Failure to LVAD Support Component Pressures
mmHg Heart Failure
LVAD
LAP 25 8
LVP 100 60
LVP
ED
25 5
AoP 95/70 99/89
MAP 82 95
RAP 20 3
RVP 40 33
RVP
ED
17 3
PAP 35/28 28/11
MPAP 31 18
P
mc
20 7

Perfusion
Successful cardiac output was re-established from pathological (2.3L/min) to
acceptable (5.1 L/min) perfusion levels while operating the pump at a constant
2200rpm (Figure 5-22).

5-30
0 1 2 3 4 5 6 7 8
0
20
40
60
80
100
120
140
160
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVAD Performance Characteristics for the Support Condition
Diastole
Systole
2400 Rpm
2200 Rpm
2100 Rpm

Figure 5-23 Non-Pulsatile LVAD operation in the pulsatile LHF environment

0 1 2 3 4 5 6 7 8 9 10
0
5
10
15
20
25
30
35
40
Flow Rate (L/min)
E
f
f
i
c
i
e
n
c
y

(
%
)
LVAD Efficiency for the Support Condition
Diastole
Systole
2400 Rpm
2200 Rpm
2100 Rpm

Figure 5-24 Non-Pulsatile LVAD efficiency in the pulsatile LHF environment

5-31
LVAD performance during the pulsatile support condition is displayed in Figure
5-23, where the pump operates along the interpolated characteristic curve for 2200
rpm. The limits on this curve correspond to the pressure difference from the left
ventricle to the aorta throughout the entire cardiac cycle, i.e. from systolic
(35mmHg) to diastolic (90mmHg) periods. The average flow rate for each cardiac
cycle (5.1 [L/min]) is determined from the mean time spent in systole (40%) and
diastole (60%) (Table 5-9).
Table 5-9 Pressure and flow conditions for diastolic and systolic periods
Diastole Systole
Pressure (mmHg)
Pump P 90 35
LVP 5 60
AoP 95 95
Perfusion (L/min) 4.2 6.5

The pump stage efficiency curve was interpolated and displayed in Figure 5-24.
Efficiency rose from a diastolic value of 30 % to briefly peak at 33%, before falling
to 23% during systole.

5-32
25 30 35 40
0
0.05
0.1
0.15
0.2
0.25
0.3
Diastole
Systole
Time (Sec)
R
a
d
i
a
l

F
o
r
c
e

(
N
)
LVAD Support Radial Force Magnitude

0 1 2 3 4 5 6 7
0
0.05
0.1
0.15
0.2
0.25
0.3
Systole
Diastole
Flow Rate (L/min)
R
e
s
u
l
t
a
n
t

R
a
d
i
a
l

F
o
r
c
e

(
N
)
Comparison of Radial Force
2400 Rpm
2200 Rpm
2100 Rpm

(a) Radial Magnitude (a) Radial Magnitude

0.1
0.2
0.3
30
210
60
240
90
270
120
300
150
330
180 0
LVAD Support Radial Force Direction
Force X (N)
F
o
r
c
e

Y

(
N
)
Systole
Diastole

0.2
0.4
30
210
60
240
90
270
120
300
150
330
180 0
Comparison of Radial Force Direction
Force X (N)
F
o
r
c
e

Y

(
N
)
Systole
Diastole
2400 Rpm
2100 Rpm

(b) Radial Direction (b) Radial Direction

25 30 35 40
0
0.5
1
1.5
2
2.5
3
3.5
Diastole
Systole
Time (Sec)
A
x
i
a
l

F
o
r
c
e

(
N
)
LVAD Support Axial Force Magnitude

0 1 2 3 4 5 6 7
0
0.5
1
1.5
2
2.5
3
3.5
Systole
Diastole
Flow Rate (L/min)

A
x
i
a
l

F
o
r
c
e

(
N
)
Comparison of Axial Force
2400 Rpm
2200 Rpm
2100 Rpm

(c) Axial Magnitude (c) Axial Magnitude

25 30 35 40
-0.01
-0.008
-0.006
-0.004
-0.002
0
Systole
Diastole
Time (Sec)
T
o
r
q
u
e

(
N
m
)
LVAD Support Reaction Torque

0 1 2 3 4 5 6 7
-0.01
-0.008
-0.006
-0.004
-0.002
0
Systole
Diastole
Flow Rate (L/min)

T
o
r
q
u
e

(
N
m
)
Comparison of Reaction Torque
2400 Rpm
2200 Rpm

(d) Reaction Torque (d) Reaction Torque

Figure 5-25 Fluctuation of force with systole
and diastole
Figure 5-26 Forces from pulsatile and non-
pulsatile test results
0
90
180
270
0
90
180
270
5-33
Hydraulic Force
Impeller radial force magnitude (Figure 5-25(a)) and direction (Figure 5-25(b)),
axial hydraulic force magnitude (Figure 5-25(c)) and motor reaction torques (Figure
5-25(d)), were recorded in the LVAD supported simulated heart failure environment.
The force magnitudes fluctuated within each simulated heat beat. Values
corresponding to diastolic and systolic periods are compared in Table 5-10. Radial
force direction changed for systolic and diastolic periods, while axial force was
always directed toward the pump inlet eye.
Table 5-10 LVAD Support Force/Torque Magnitudes at Systole and Diastole

The recorded LVAD support forces were cross-referenced with previous non-
pulsatile values at corresponding flow rates for systole and diastole. The magnitudes
and directions were found to replicate interpolated non-pulsatile test results for 2200
rpm (Figure 5-26).
Radial force magnitude reciprocated the path outlined in Figure 5-26(a) for each
cardiac cycle. The force reduced to the minimum design point value during each
transition, resulting in a maximum change of 0.18N. The direction of the radial force
vector (Figure 5-26(b)) pointed away from the cutwater during diastole (110
o
), and
reversed direction to point toward the final volute section (310
o
) during the systolic
period. Figure 5-26(c) describes the 0.6N fluctuation of axial force magnitude
between systolic and diastolic limits corresponding to interpolated non-pulsatile axial
force data. Finally, a minimal 1.2mNm change in reaction torque was observed in
Figure 5-26(d) for this level of LVAD support.

Force Systole Diastole
Radial (N) 0.21 0.11
Axial (N) 2.0 2.6
Toque (mNm) 7.1 5.9
5-34

0 1 2 3 4
16
18
20
22
24
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
0 1 2 3 4
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVP
0 1 2 3 4
50
60
70
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
AoP
MAP
2.4 2.6 2.8 3 3.2 3.4
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP

0 1 2 3 4
8
10
12
14
16
18
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
0 1 2 3 4
0
50
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVP
0 1 2 3 4
80
90
100
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
AoP
MAP
1.2 1.4 1.6 1.8 2 2.2
0
20
40
60
80
100
120
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LAP
LVP
AoP
MAP


1 2 3 4
0
20
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
0 1 2 3 4
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RVP
0 1 2 3 4
20
30
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
PAP
MPAP
2.4 2.6 2.8 3 3.2 3.4
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
RVP
PAP
MPAP

0 1 2 3 4
0
20
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
0 1 2 3 4
0
20
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RVP
0 1 2 3 4
20
30
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
PAP
MPAP
1.2 1.4 1.6 1.8 2 2.2
0
5
10
15
20
25
30
35
40
Time (sec)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
RAP
RVP
PAP
MPAP


Figure 5-27 Systemic (a) and Pulmonic (b)
BI-HF pressure distribution
Figure 5-28 Systemic (a) and Pulmonic (b)
BI-VAD supported pressure distribution

0 0.5 1 1.5 2 2.5 3 3.5 4
0
1
2
3
4
5
6
Time (sec)
P
e
r
f
u
s
i
o
n

R
a
t
e

(
L
/
m
i
n
)
Perfusi on Rate
MSQ
SQ
MPQ
PQ

0 0.5 1 1.5 2 2.5 3 3.5 4
0
1
2
3
4
5
6
Time (sec)
P
e
r
f
u
s
io
n

R
a
t
e

(
L
/
m
i
n
)
Perfusi on Rate
MSQ
SQ
MPQ
PQ

Figure 5-29 Perfusion Rate for Rest Figure 5-30 Perfusion Rate for Left Heart
Failure.
5-35
Heart Failure with Bi-VAD Support
Bi-VAD configuration (B) was briefly tested under conditions of heart failure. The
right impeller incorporated a 22.5 degree backward impeller with no shroud cased in
a single volute, while the left impeller had a 112.5 degree forward impeller with no
shroud in a circular casing.
Figure 5-27 to Figure 5-30 describes the hemodynamic effect of Bi-VAD insertion
into a simulated heart failure condition. With appropriate manipulation of systemic
and pulmonary vascular resistances, physiological conditions representative of
normal heart function where re-established.
Mean Aortic pressure was improved from 60 to 93mmHg, although mean pulmonary
artery pressure was only slightly reduced from 30 to 28mmHg. A reduction in left
atrial pressure (20 to 8mmHg) was also observed.
The high level of pulmonary arterial pressure is due to the remaining right heart
function. That is, it would appear that the right heart function was not sufficiently
reduced to correctly imitate biventricular failure. Furthermore, leakage from left to
right sides of the pump also contributes to the high pulmonary pressure. In any case,
techniques described in later chapters may aid in the reduction of the contribution of
pulmonary pressure by the VAD.
Bi-VAD support established an acceptable perfusion level of 5.4 L/min from the 2.7
L/min encountered during simulated heart failure.
Although the results indicate the somewhat successful preliminary operation of the
Bi-VAD in re-establishing perfusion, the results would benefit from future
optimisations.

5-36
5.4 Discussion
5.4.1 Experimental Method
Isolation of impeller hydraulic force was successfully achieved by separating the
impeller, bearing and motor drive assembly from each volute casing. Mounting this
assembly on the high stiffness force transducer prevented impeller movement within
the pump cavity while accurately recording force and torque magnitudes in each
degree of freedom. The flexible seals prevented transmission of force from the
impeller assembly to the volute casing. The installation of the small metallic sleeve
around the shaft at the inlet eye was effective in eliminating the momentum effect of
the fluid entering the pump. Without such sleeve, the fluid jet streams would act on
the shaft, thus creating an additional radial force, albeit low in magnitude.
Any impeller dynamic instability was eliminated by acquiring offset values during
dry pump operation. The influence of noise on the static force readings in the non-
pulsatile environment was removed by digitally filtering the transducer signals to
produce time averaged values. The level of filtering did not impose on the magnitude
of force variation at the heartbeat frequency during pulsatile heart failure simulation.
The 100N full scale range of the J R3 force transducer presented a limitation with
respect to resolution, sensitivity and noise, preventing the investigation of high
frequency dynamic forces. Furthermore, transient pressure surges due to mock loop
valve closure also masked dynamic results. Although advanced signal processing
techniques could be applied to the raw data to improve dynamic results, these high
frequency dynamic force magnitudes are not expected to dominate the static resultant
force data.
5-37
5.4.2 Non-Pulsatile Operation
The simultaneous capture of non-pulsatile hydraulic performance and force data was
successfully conducted while maintaining pump speed and setting the actuation rate
of the afterload resistance valve from shut-off. This automated technique provided a
quick and efficient means of testing the multiple impeller/volute configurations.
Performance characteristic curves and non-dimensional data are discussed in the
following sections for the LVAD and RVAD impeller/volute configurations.
LVAD
The LVAD design point of 5L/min @ 100mmHg was achieved at 25% higher
rotational speed (2400rpm) than theoretically designed (1921rpm), indicating an
efficiency loss.
The family of performance curves (Figure 5-5) indicate pump characteristics at
design and off design capacities. The non-dimensional performance graph of specific
head versus specific capacity (Figure 5-7) groups these results and compares the
characteristics of each impeller volute configuration. This information is useful in
determining the response of the device to changes in physiological conditions,
induced by vascular resistance alteration. A flat performance curve is desirable, as
drastic changes in rotational speed are not required to increase perfusion while
maintaining sufficient mean arterial pressure. A flatter performance curve is
characteristic of impellers incorporating high discharge blade angles. The (112.5)
impeller displayed the flattest response, particularly above design, where pressure
fell considerably in this region for each of the low discharge angled impellers.
The non-dimensional shut-off head range of 0.5 - 0.6 for each backward facing blade
configuration is consistent with that identified by Smith (2004) in a study of blood
pump non-dimensional data. The shut-off head of 0.4 for the (112.5) impeller
indicates a relatively larger amount of slip and separation within the impeller blades.
5-38
Efficiency
Efficiencies are also compared in Figure 5-5 for each impeller/volute configuration.
The single volute with backward discharge blade angle (22.5
o
) LVAD configuration
exhibited the best efficiency at the design point. The smooth transition of flow from
impeller to volute contributes to this effect, since volute velocity is constant around
the impeller periphery at this point.
The relative drop in best efficiency of the double volute configuration is attributed to
the resistive effect of the splitter plate and additional separation loss contributed by
the second cutwater. However, efficiencies at off design conditions (particularly part
flow) are significantly higher than the single volute. This is due to the effect of the
impeller discharging fluid into a more uniform pressure distribution (Stepanoff
1957). The splitter also restricts the highest achievable capacity, as the extra
boundary layers grow in size and contribute to blockage of the flow passage. This
effect would be even more pronounced in higher viscosity fluids (blood) than the
fluid (water) used in these experiments.
The reduction in circular volute configuration efficiency is attributed to the
separation and formation of eddy currents at cutwater. The turbulent fluid transition
from volute to throat generates significant eddy currents and recirculation, which
contributes to losses and effectively partially blocks the throat area. This
recirculation is observed in the previous flow visualisation study (Tan, Timms et al.
2004).
The lower efficiency of the 112.5
o
impeller discharge angle in the single volute
configuration is expected in pumps employing forward facing blades, and is due to
the inability of the volute to efficiently convert the high speed fluid jet streams off
the impeller into pressure.
The specific power results displayed in Figure 5-8 provide an analysis of the power
requirements of each impeller/volute configuration with increasing capacity.
Difficulties in obtaining exact measurements of input shaft power contribute to offset
variations between volutes, thus the accuracy of the values are questionable.
However, a qualitative trend of specific power with capacity is evident. As expected,
the backward swept impellers displayed a reducing gradient of power with capacity,
while the forward blades characteristically observed a slight increase in gradient.
5-39
Axial Clearance Variation
The effect on hydraulic performance and efficiency of semi-open impeller axial
clearance variation in a variable afterload environment at constant rotational speed
was investigated and displayed in Figure 5-6(a). By progressively increasing the
clearance gap, more fluid would escape over the impeller vanes, thus reducing the
hydraulic efficiency and consequently pressure and flow.
The reduction in efficiency as the gap increased from 0.1 - 2.5mm translated to a
reduction in output flow rate while a constant afterload pressure was maintained.
Figure 5-6(b) displays this variation in flow (4.8 - 6 L/min) and efficiency (10 -
21%) for a constant afterload of 100mmHg.
This effect is dependant on the ratio of blade height to clearance gap. Therefore, the
change in efficiency for a given impeller axial displacement is more pronounced in
impellers with small vane heights. The type of impeller also contributes to the
magnitude, with semi-open impellers allowing for the greatest variation in efficiency.
RVAD
The RVAD design point of 5L/min @ 20mmHg was achieved at 50% higher
rotational speed (3000rpm) than theoretically designed (1921rpm) in the single
volute configuration. The circular volute could not attain the required condition at the
tested rotational speeds. Efficiencies were not evaluated for the RVAD
configurations, as input power was not monitored in such cases. The lower power
requirements proved too difficult to reliably extract with the current technique.
The poor performance was reflected on the non-dimensional pump curve in Figure
5-10. A maximum specific head at shutoff of 0.4 is well below the design point of
0.5. This represents the inability for the impeller to develop the required pressure,
which indicates excessive hydraulic inefficiency caused by a relatively large degree
of slip and/or leakage from outlet to inlet diameter over the closed vanes.
Furthermore, the specific capacity design point of 0.29 is not approached in either
single (0.19) or circular volute (0.14) configuration results. The maximum flow
coefficients were further limited by the inherent size resistance of the valves and
flow meters used in the mock loop.
The relatively poor performance of the circular volute can be attributed to the
required geometrical cutwater location and the large throat area required. That is, the
5-40
throat area occupies half of the circular volute. This reduces the effectiveness of the
volute by half, and thus there is less volute section useful for pressure recovery of
discharge velocity. Increase turbulence and separation losses are also expected in
this configuration.
Performance related to Blood Pumps
Discharge Angle
The performance characteristics suggest a higher discharge angle is preferable in a
blood pump application. This is due to the ability to increase perfusion to levels
required during exercise while maintaining sufficient arterial pressure without a
change in rotational speed. Although the forward vanes display a favourably flat
performance curve, theses are not recommended in practice. Their pulsing effect and
the difficulties associated with volute collection and pressure conversion lead to the
observed decrease in efficiency.
The investigation would be improved by the inclusion of the radial (90) degree
impeller results. However, poor performance of the first impeller iteration negated
their applicability. This impeller was designed using parameters recommended by
various centrifugal pump design methods, which produced a small impeller vane
height at the exit width (0.6mm). When coupled with a top and bottom shroud, the
boundary layer blockage at this exit area is significant, and prevented the free flow of
fluid from the impeller to pump outlet. The next iteration would benefit from a
larger impeller exit vane height, despite departing from the recommended design
procedure.
The purpose of this experiment was achieved by demonstrating the forward vane
configurations ability to produce flatter pump curves. The flat response is also
observed in low angle impellers when operated below design. Therefore, if the pump
is designed at an operating point above the expected operating condition, the pump
will mostly operate below design and therefore in the flat region of the performance
curve. This would lead to lower hydraulic efficiency, but a more favourable
physiologic response. Ultimately, some energy may be saved by removing the need
for significant rotational speed changes under variable vascular resistance conditions.
5-41
Volute Type
Despite the double volute configuration not attaining the highest value of best
efficiency, this volute may improve overall efficiency in the VAD support condition,
as efficiency is higher at off design flow capacities. Since blood pumps function at a
range of off design operating points, dependant on heart function, the overall
efficiency throughout the duration of VAD support may be higher than the single
volute type. This conclusion is most applicable for cases where some degree of heart
function remains. However, the additional cutwater and blood contacting surfaces of
the double volutes splitter may detrimentally contribute to increased blood damage
and increased flow blockage at high flow capacities.
Axial Clearance
The observed results for axial clearance variation have applications for physiological
control of magnetically levitated centrifugal blood pump impellers. Active axial
movement of the impeller within the LVAD casing varies output characteristics
without the need for rotational speed changes. However, precise position control is
still required for control of output flow rates.
The effect of axial clearance variation is an important feature of the Bi-VAD design.
In some situations, a different output flow rate may be required from either the left or
right pump cavity. This may not be achieved by simply changing the relative
rotational speed of left and right impeller, as both sets of vanes are attached to the
same rotating body. Instead, by actuating the impeller along the axis of rotation, the
axial clearance changes above both sets of impeller vanes, and thus efficiency (and
output flow) is altered in both cavities. This results in improved performance in one
cavity, and a simultaneous reduction in performance in the other, creating the desired
difference in flow conditions.
5-42
Hydraulic Force
Radial and axial hydraulic thrust magnitude and direction results for the single (22.5)
LVAD impeller in all volute types are discussed in the following sections.
Radial Force
Radial force magnitudes for each volute type (Figure 5-11) replicated the associated
theoretical trends with respect to flow capacity. Maximum resultant radial force was
less than 0.6 [N] in all cases, which is in the order of the impeller weight. This
minimal force is greatly attributed to the relatively small discharge blade heights
(1.4mm) employed.
The resultant radial force in the single volute acted away from the cutwater at shut-
off, and toward the cutwater at above design capacity (Figure 5-11). This is contrary
to the generalisation for radial thrust direction (Figure 4-10); however this trend is
consistent with the relative influence of cutwater separation and fluid
acceleration/deceleration upstream of the volute throat. The minimal impeller/volute
angle mismatch, coupled with the characteristic low pump specific speed, reduces the
influence of the cutwater separation component of radial force. The degree of fluid
acceleration/deceleration upstream of the volute throat, dictated by the operational
flow capacity with respect to the design point, therefore has a greater impact on
radial force development, causing the directional vectors to approach the 0-180
o

plane.
The results from the integration of volute pressure reveal similar radial thrust
magnitudes to those recorded from the force transducer. That is, a maximum shut-
off force of 0.32N was similar in magnitude to the 0.29N recorded from the
transducer. The directional vectors are not completely consistent with transducer
results, however both shut-off and full capacity vectors are similarly found in the left
and right planes respectively. Limitations of the pressure transducers used for
pressure measurement (1mmHg resolution) coupled with known limitations of the
pressure integration technique lead to acceptable deviations in results. Despite these
limitations, the aim of transducer verification was achieved.
Calculation
Discrepancies in radial thrust predictions from measured values in the VAD
application are evident when comparing each authors technique for radial thrust
5-43
calculation (Appendix C). Methods that did not regard specific speed faired
considerably worse than those that did, for which the specific speed of the blood
pump application was at the lower end of the scale for radial thrust factor selection.
Interpolation and selection errors were therefore amplified in such cases. Despite
these limitations, tangible correlation was found between a selection of authors
techniques and experimental results obtained in this study.
The method for radial thrust prediction in single volute applications was best
described by Karassik, and was attributed to the consideration of specific speed when
determining the radial thrust factor. A predicted shutoff thrust factor of 0.11 was
sufficiently close to the measured value of 0.09 (Figure 5-16).
The estimation of double volute results was best made using the ANSI method.
Small deviations in predicted radial thrust factor occurred at the extremes of shutoff
and maximum capacity.
The Stepanoff method was not appropriate for radial force calculation in single and
double volute configurations due to the lack of specific speed consideration. Since
specific speed has less influence on the cutwater separation in circular volutes, the
method was sufficient for these radial thrust predictions. The ANSI also provided
techniques for circular volute radial thrust prediction; however no consideration is
given to the influence of changing outflow capacity, and was therefore discounted.
5-44
Axial Force
The predicted theoretical trend of axial force with respect to flow capacity was
demonstrated in the semi-open and closed type impeller configuration results. The
semi-open impeller encountered a greater axial force at the design point compared to
the closed impeller. The increased force is a direct result of the removal of the top
shroud, which causes a reduction in top pressure opposing that acting on the bottom
of the impeller hub.
All axial force values were directed toward the impeller inlet eye, since discharge
pressure acting over the entire back shroud was not completely countered by pressure
acting on the smaller surface top shroud.
The technique of incorporating a double sided impeller to balance axial force was
evaluated during the investigation of a previous iteration (Timms, Tan et al. 2004).
The results indicated the successful reduction in axial force at design point for single
and double sided semi-open impellers respectively.
The use of other balancing techniques, such as balance holes and radial ribs, were not
investigated. Although these techniques have been implemented in other VAD
designs, they require further fluid flow analyses to warrant acceptance in terms of
blood cell preservation. Balance (Washout) holes are used to improve secondary
flows beneath the impeller to circumvent thrombosis formation. However, the flows
present an efficiency loss, and disrupt the flow at the impeller inlet vanes. Radial ribs
beneath the impeller act to stir the flow beneath the impeller to prevent the formation
of stagnant regions. These too present efficiency losses, as additional torque is
required for these vanes. Finally, the ability to washout the central impeller region is
not addressed in either technique.
Calculation
The techniques for axial thrust calculation proposed by each author predicted lower
axial thrust than experienced in the tested blood pump application.
Axial thrust predictions made by Stepanoff described the similar trend observed in
experimental results of slightly reducing axial thrust for increasing capacity, which is
attributed to reduction of pressure on the performance characteristics curves. The
actual magnitudes predicted with this method were closest to recorded results.
5-45
5.4.3 Pulsatile Operation
LVAD Support
The complete mock circulation loop created a suitable pulsatile left heart failure
environment for testing the hemodynamic and force characteristics of the closed
impeller/single volute LVAD configuration.
The insertion of the device into the mock loop simulating left heart failure
successfully re-established perfusion from pathological (2.3 L/min) to acceptable
(5.1 L/min) levels. Alleviation of pulmonary congestion was also demonstrated by
reducing left atrial pressures to acceptable levels. This reduction is somewhat
attributed to the expected natural response of the circulatory system to the
introduction of the LVAD. That is, the body no longer needs a high mean circulatory
pressure (P
mc
) to maintain maximum perfusion. The body therefore reduces fluid
retention. This was simulated by removing sufficient liquid from the mock
circulation loop. Mean aortic pressure was also restored; however pulse pressure
was characteristically diminished, but not eliminated.
Maximum left ventricular pressure was reduced from 80mmHg (Figure 5-20) to
60mmHg (Figure 5-21) after inserting the LVAD. This may be explained by a
reduction of ventricular preload, since fluid is continuously removed from the
ventricle during diastole. Consequently, LVP fails to rise beyond 60mmHg, as heart
function is further diminished / unloaded.
5-46

0 1 2 3 4 5 6 7 8
0
20
40
60
80
100
120
140
160
Flow Rate (L/min)
P
r
e
s
s
u
r
e

(
m
m
H
g
)
LVAD Performance for Tested Heart Function
Diastole
Systole
2400 Rpm
2200 Rpm
2100 Rpm
No Heart Function
Improved Heart Function
Failing Heart Function (Test)

(a) Tested Heart Function - 2200Rpm

0 1 2 3 4 5 6 7 8
0
20
40
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Flow Rate(L/min)
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)
LVAD Performance for Improved Heart Function
Diastole
Systole
No Heart Function
Normal Heart Function

0 1 2 3 4 5 6 7 8
0
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(b) Improved Heart Function 2000rpm (c) Complete Failed Heart Function 2350rpm

0 1 2 3 4 5 6 7 8
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Diastole
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No Heart Function

(d) Normal Heart Function 1800rpm

Figure 5-31 Pulsatile Hydraulic LVAD Performance in Various Heart Function Situation
5-47
Normal hemodynamic conditions of 5.1 L/min at 95 mmHg were obtained upon
insertion of the LVAD operating at 2200rpm.
Figure 5-31 displays a series of operational LVAD performance characteristics
experienced in various tested or hypothetical heart function situations.
The LVAD was found to function between two operating points along the non-
pulsatile characteristic curve for 2200 rpm, in the pulsatile left heart failure
environment (Figure 5-31a). These limits correspond to the systolic and diastolic
conditions of the cardiac cycle, and their exact location along the performance curve
is dictated by the instantaneous pressure difference from the left ventricle (LVP) to
the aorta (AoP). For example, the pressure difference between end diastolic LVP
and AoP (90mmHg) determines the diastolic point, which is independent of heart
function. Under this condition, the pump outputs 4.2 L/min for the diastolic period,
i.e. 60% of the cardiac cycle. During systole however, the failing heart contributes
energy to increase left ventricular pressure. The new difference between LVP and
MAP is dependant on the degree of heart function, and corresponded to 35mmHg in
the simulated heart failure case. A flow rate of 6.5 L/min therefore occurred for the
remaining 40% of the cardiac cycle. This result suggests that no flow exits the aortic
valve, as ventricular pressure does not develop higher than aortic pressure, and thus
the ventricle is completely unloaded. As such, the output flow rate fluctuates
between systolic and diastolic pump operating points, averaging to the actual
perfusion rate.
If heart functionality is improved (Figure 5-31b), the native heart can further
contribute to the pressure rise in the left ventricle (eg. 90mmHg). Therefore, the
pressure differential from LV to AoP is zero, and the LVAD outputs maximum flow
at systole. The diastolic pressure differential remains unchanged at 90mmHg.
Therefore, to accommodate a flow rate of 5 L/min, rotational speed must be reduced
to 2000Rpm.
However, if heart function completely fails (Figure 5-31c), the native heart does not
contribute to ventricular pressure, and the systolic and diastolic points are coincident
as the required pressure differential is a consistent 90mmHg. To maintain a 5 L/min
flow rate, impeller speed must increase to 2350rpm.
5-48
Should impeller rotational speed fall below 1800rpm (Figure 5-31d) in a normally
functioning heart, retrograde flow would occur during diastole, as the pump cannot
achieve the required 90mmHg differential. This is analogous to a leaking aortic
valve. During systole however, the normal heart would achieve a LVP of
120mmHg, therefore the pump has a negative pressure differential (-30mmHg) from
ventricle (120mmhg) to aorta (90mmHg), enabling greater flow rates in this period.
Hydraulic efficiency was also affected by the residual level of heart function
throughout the cardiac cycle in the left heart failure test conditions. As shown in
Figure 5-24, the LVAD rarely operated at best efficiency (33%), since the best
efficiency point was designed and tested at a capacity near 5L/min, and the diastolic
and systolic values were 4.2 L/min (30%) and 6.5 L/min (22%) respectively. The
average hydraulic efficiency was therefore below 30%. Efficiency would be
improved if the diastolic capacity coincided with the best efficiency point (BEP),
since the LVAD operates at this condition for 60 percent of each cardiac cycle.
However, knowledge of the diastolic flow rate depends on the rotational speed of the
pump, which is dependent on residual native heart function. This is different for each
patient, and thus impractical to predict as a design condition for BEP.
The suggestion of BEP capacity design at a value above the expected operating
overall perfusion capacity made in Performance related to blood pumps (4.4.2 -
Non-pulsatile Operation) may not contribute greatly to an efficiency reduction in the
pulsatile condition. The efficiency gradient is lower below design capacity, and
drops sharply thereafter. Therefore, efficiency would not greatly reduce over two
operating points below BEP.

5-49
Hydraulic Forces
Impeller force values recorded in the pulsatile left heart failure environment
reciprocated a characteristic path (outlined in Figure 5-26a) throughout each cardiac
cycle. The limits corresponded to interpolated force values obtained during non-
pulsatile operation at the identical pressure and flow conditions observed during the
systolic and diastolic periods. For example, radial force magnitude in the single
volute is observed to reduce from the diastolic value (0.11N) to a minimum value
(0.03N) before increasing to the systolic value (0.21) during transition from diastole
to systole. This trend is reversed for transition back to diastole, and is somewhat
observable in Figure 5-25a. This characteristic represents the oscillation about the
pump design point, where radial force is at a minimum. Radial thrust direction also
changes direction depending on the phase of the cardiac cycle (Figure 5-26b), again
dictated by non-pulsatile results.
Axial force is also found to fluctuate throughout the cardiac cycle (Figure 5-25c).
That is, the magnitude oscillated between the systolic and diastolic values
corresponding to interpolated non-pulsatile axial force data. Axial force reduces
during systole, as the required pressure differential across the pump reduces. This
effectively reduces the generated axial force toward the impeller inlet eye.
Finally, the relatively small change in impeller torque between systolic and diastolic
periods (Figure 5-26d) indicates very little restraining torque variation and thus
device rotation in the body. The variation in torque is indicative of the relative power
requirements of the device from the systolic to diastolic periods. For example, a
normally functioning heart would produce the greatest torque variation, as little
power is required of the VAD during systole. Support of a completely failed heart
would not produce any torque differential, since the ventricle no longer alleviates any
pumping duty during systole. Device rotation during operation could potentially lead
to movement of cannula and promote bleeding at the interface; however this is
deemed insignificant due to the low torque differential experienced, particularly in
conditions of heart failure.

5-50
Bi-VAD Support
The preliminary tests indicate the potential for the proposed Bi-VAD device to
successfully operate in the circulatory environment of Bi-ventricular heart failure.
The single device may require time differing output flows from left and right output
cannula. It is anticipated that the technique of impeller axial actuation will
sufficiently accommodate this requirement.
Significant leakage flows from left to right chambers plagued initial iterations. This
leakage results from fluid in the higher pressure left chamber infiltrating the lower
pressure right chamber via the small radial clearance gap between the impellers. This
leakage is analogous to a ventricular septal defect (Hole in the heart), and is
anticipated as clinically insignificant, should leakage flow create a right to left
imbalance ratio of less than 1.75: 1.
Clinically, this corresponds to a defect around 0.5 cm
2
, where surgical intervention is
not necessary. However, should the defect enlarge to 1.0 cm
2
, the flow ratio would
increase beyond 2:1, requiring the suturing of a septal patch.
The issue of leakage in the Bi-VAD was addressed by simply reducing the clearance
area for fluid to pass. Attempting this at the left impeller periphery (50mm) was not
practical, thus the circumferential gap surrounding the right impeller (23mm) was
reduced to minimise leakage. The resulting clearance gap is in the order of 0.1 cm
2
.
This gap should be below the threshold for clinical significance (0.5cm
2
), since the
pressure differential from left to right chambers is constant throughout the cardiac
cycle, whereas the natural heart is only exposed to the maximal pressure differential
during the systolic phase.
Further research is required for this design to improve hemodynamic performance,
including the incorporation of an axially actuating impeller for left and right
perfusion balancing.
5-51
5.4.4 Application to Bearing System Design
The impeller of a rotary type VAD encounters loads resulting from static and
dynamic hydraulic forces. Although dynamic hydraulic forces predominantly affect
the stability and operation of industrial centrifugal pumps (Flack and Allaire 1984),
static forces take precedence as the most important radial load in third generation
rotary blood pumps. Increased static force results in excessive power diversion to a
magnetic bearing system, a reduction in hydrodynamic bearing suspension capacity,
and increased wear of mechanical bearing systems.
The following impeller/volute recommendations are based on creating favourable
conditions for each bearing system considered. Factors such as hydraulic efficiency
and potential blood damage were not considered.
Magnetic Bearing Systems
The magnetic suspension system must maintain sufficient clearance between the
impeller and pump housing to minimize touchdown during pulsatile operation. This
is achieved by the generation of magnetic forces to counteract both static and
dynamic forces imposed on the impeller. The reduction of static load is paramount
in conserving energy required for magnetic bearing function, while improving
bearing ability to counteract dynamic perturbations. However, complete elimination
of this force can increase dynamic instability (whirl), especially in passively
supported degrees of freedom (Chung, Zhang et al. 2004).
Load Capacity
Resultant thrust is of particular importance when employing magnetic bearings to
support the rotor, as precise loads must be specified in order to complete the bearing
design (J apikse, Marscher et al. 1997). Magnetic bearing systems often utilize a
combination of active or passive support to produce complete impeller suspension
(Masuzawa, Kita et al. 2000).
Knowledge of the expected hydraulic force provides the ability to determine the
requirements of magnetic bearing configurations to minimise the incidence of
impeller touchdown. This is especially relevant in each passively supported DOF,
where a specific volute / impeller configuration may reduce the hydraulic force to
within acceptable operational limits. Each actively suspended DOF benefits from this
5-52
information by allowing the bearing design to provide sufficient magnetic force to
prevent touchdown in pulsatile conditions.
The impeller weight and moment of inertia will also influence the operational
capacity of magnetic bearing systems to counteract impeller loads. A lightweight
impeller with a low moment of inertia will reduce the power requirement of the
magnetic bearing to overcome gravity, impact and gyroscopic forces. Finally,
incorporation of permanent magnets in the stator can help to alleviate the attraction
of motor permanent magnets embedded in the rotor, while the maintenance of large
clearance gaps will reduce hydrostatic and hydrodynamic forces.
Power
The power requirements of a magnetic bearing system must be reduced to improve
overall device efficiency and consequent battery life. Device operational power and
thus efficiency is of primary concern in an implantable device, therefore the
reduction of static force directed toward actively suspended DOFs is paramount in
conserving energy required for bearing function. This would provide a larger bearing
capacity to prevent touchdown from external shocks.
Therefore, the correct selection of impeller/volute configurations for magnetic
bearing configurations can help to alleviate the power requirements for impeller
suspension. Radial and axial type magnetic bearing suggestions are outlined below.
5-53
Radial Type
In a radial type magnetic motor-bearing, a double volute would reduce the active
magnetic power requirements of the device in a pulsatile support condition (i.e latent
heart function). This is a result of a lower range of hydraulic force magnitude
required for counteraction by the bearing over the operational systolic and diastolic
flow rates.
Should the condition require non-pulsatile support (i.e. no latent heart function), the
system would benefit from a single volute, as the device would mostly operate at the
pumps best efficiency point.
A circular volute would require the most magnetic bearing power in any support
condition. However, if the bearing system was set to operate at minimum power in
the non-pulsatile support mode, the impeller would move off centre until hydraulic
forces around the circumference are nearly balanced. That is, the impeller would
offset toward the cutwater to produce a pseudo single volute.
A closed impeller would reduce the likelihood of impeller touchdown in the
passively supported axial direction, since axial force was found to be lower in this
configuration than in a semi open type.
Although not tested, a completely open impeller would be expected to further reduce
axial thrust; however the incorporation of magnetic material would prove difficult.
Alternatively, the double (suction) impeller configuration would also improve axial
touchdown capacity as pressure distribution is considerably balanced, thus drastically
minimising resultant axial thrust.
5-54
Axial Type
An axial type bearing relies on passive suspension in the radial direction; therefore
the double volute would improve impeller touchdown capacity. However, radial
dynamic instability may result, even though double volute radial thrust is not
completely eliminated. The magnitude of radial force to minimise dynamic
instability needs further investigation.
Should the residual magnitude encountered in the double volute prove insufficient,
the use of a single or circular volute should be considered. Of these latter
configurations, a single volute would be unstable as the force approach zero at the
design point. However, this occurs briefly, as the device operates at the design point
only while transitioning from the operating points for diastole and systole.
Compared to a semi-open impeller, a closed impeller would reduce the active
magnetic power to maintain suspension in the axial direction, due to the reduction of
hydraulic force. Alternatively, the use of a double (suction) or open type impeller
would further reduce axial force magnitude and thus bearing power. However, again
the incorporation of magnetic material in the latter might prove difficult.
Hydrodynamic Bearing Systems
The stability of a hydrodynamic bearing systems increases with the introduction of a
static bias force (Chung, Zhang et al. 2004). The weight of the impeller can serve
this purpose; however the bias may be increased in the desired direction with the
correct impeller/volute selection. For example, implementing a circular volute will
guarantee a bias radial force during normal function, as the pump is not expected to
operate at zero capacity. Conversely, this bias force will oscillate about a minimum
value should the pump operate at design flow in a single volute. This may be
overcome by designing the pump for a condition above expected operation, resulting
in a fluctuating but constant part load bias force.
Mechanical Bearing Systems
The lifetime of mechanical type bearings rely heavily on the frictional wear caused
by bearing loads. Since the impellers are constrained in these cases, minimisation of
force should result in minimal dynamic radial instability.
Therefore, the results indicate a closed type impeller operated in a double volute
would be most suitable for mechanical type bearing applications.
5-55
5.5 Conclusion
5.5.1 Force and Performance
The single suction LVAD demonstrated the ability to re-establish hemodynamic
parameters of pressure and perfusion from pathological to normal conditions. The
pump operated along the non-pulsatile characteristic curve in the diminished
pulsatile support environment. The limits on this curve corresponded to differential
pressure requirements during systole and diastole. It is therefore possible to predict
impeller hydraulic force in the pulsatile support environment by evaluating force
during non-pulsatile operation between these limits. The magnitude and direction of
thrust is influenced by the extent these limits differ from the pumps design point.
The resultant radial and axial force magnitudes were successfully compared to
predictions made using a number of authors equations for thrust. Measured radial
thrust magnitudes in the single, double and circular volutes were closely matched to
predictions using Karrasiks, ANSIs and Stepanoffs methods respectively. Radial
thrust direction was influenced by two components, i.e. cutwater separation and fluid
acceleration/deceleration upstream of the throat. The latter was most influential in
the low specific speed VAD application. Axial thrust in all volute types was similar
for the closed impeller, and closely predicted by Stepanoff.
The hydraulic performance results indicate the favourable application of high vane
discharge angles with respect to physiological control. The same effect could also be
achieved by designing an impeller with a BEP above (e.g. 7 L/min) the expected
operating point (5 L/min). A bias radial force, beneficial for passive radial bearing
systems, would also be created in this case in a single volute.
Impeller axial actuation altered pump hydraulic efficiency and thus output flow at a
constant RPM. This is most important for the Bi-VAD application, where the left and
right impellers rotate at the same speed but may require time changing output flows.
By axially actuating the common impeller, efficiency would simultaneously increase
and decrease in opposing chambers of the pump. This effect was most pronounced in
a semi-open impeller incorporating small blade heights.
5-56
5.5.2 Bearing Design
The presented hydraulic force results allow the bearing designer to select the most
appropriate impeller/volute configuration to improve stability in hydrodynamic,
minimise magnetic power requirements of the magnetic, and improve the wear
lifetime of the mechanical type bearing. Ultimately, bearing suspension stiffness may
be designed to minimise impeller touchdown in each actively or passively supported
DOF.
With respect to magnetic suspension systems, a radial type magnetic bearing VAD
should employ a closed type impeller to improve touchdown capacity in the
passively supported axial direction, and a double volute configuration to reduce
active radial magnetic power. This selection comes despite lower recorded forces at
the design point of a single volute, since the device rarely operates for long periods
of time exactly at the design point throughout the cardiac cycle.
Since an axial type bearing relies on passive suspension in the radial direction, the
low force characteristics of a double volute would minimise radial touchdown.
However, this minimal radial force may be too small to reduce dynamic instabilities.
The magnitude of bias radial force for this purpose requires further investigation.
Should a larger radial bias force prove beneficial, a concentric volute should be
considered. Finally, a closed type impeller would reduce active magnetic power in
the actively supported axial direction.

Chapter 6 VAD Design Summary
6-1
Chapter 6
VAD Design Summary

6.1 Introduction
This chapter summarises the final VAD designs, concluded from research conducted
within this thesis. These designs form the basis of PCT Patent Application
WO2004/098677 and follow up Provisional Patent Application AU2004906579. A
detailed description of each design is provided in Appendix G.
Each VAD design presented in this chapter represents a preferred first iteration.
Future investigations into each configuration will reveal the optimum design and
complete specification.

6-2

Figure 6-1 Exploded View of Bi-LVAD Design
6-3
6.2 Bi-LVAD
The Bi-LVAD design features the following advantages over conventional single
sided centrifugal type left ventricular assist devices.
Firstly, implementation of the double sided impeller completely eliminates the
stagnant region beneath the back shroud, a common site for thrombus formation in
conventional devices.
Secondly, axial hydraulic force is considerably balanced by introducing symmetrical
flow into the device. This is beneficial for a device relying on active magnetic
levitation in the radial degree of freedom. The incidence of impeller touchdown in
the axial direction is minimised, as the entire passive bearing capacity generated
from the active control is available to absorb impact shocks.
It is recognised that these advantages may be approached in a single sided impeller
by employing an open type impeller. However, it is difficult to incorporate magnetic
material into this impeller type for successful operation of a magnetic bearing
suspension system. Furthermore, the fluid dynamics within the annular region
between each impeller should be investigated for potential blood trauma.
Finally, the Bi-LVAD device can be essentially designed to act as two pumps in
parallel. The result of this technique is a device that can attain higher flow rates for a
given head. Consequently, a favourably flatter pump performance characteristics
curve assists in control of the device in response to changes in physiological
condition.
The preferred embodiment of the Bi-LVAD, exploded in Figure 6-1, is briefly
described in the following section, and further detailed in Appendix G.
6-4

Figure 6-2 Schematic Cross Sectional View of the Bi-LVAD design

Figure 6-3 Perspective View of the Bi-LVAD Design

6-5
Overview
The following description refers to the detailed cross section (Figure 6-2) and
perspective (Figure 6-3) views of the Bi-LVAD design.
This configuration includes two volute type inlets (5C,5D), which supply fluid to a
double sided centrifugal pump, formed by two cones (3A,3B) incorporating six vanes
(4A,4B).
The vanes are designed to produce the same pressure at the outlet (6A, 6B). This
effectively represents two centrifugal pumps operating in parallel, thus output flow
rate at cannula (40) is double the flow rate produced at each outlet (6A, 6B), for the
specific pressure increase.
Inlet flow is provided by a single cannula (39) from the left ventricle or atrium, and
is split into two conduits (39A, 39B), which connect to the inlets (5A, 5B) to provide
even flow into both cavities. In this arrangement, the variations of left ventricular
pressure developed during systole and diastole are transmitted directly to both of the
inlets (5A, 5B) of the pump via the inlet volutes, acting to balance and therefore
minimise axial thrust forces encountered by the impeller.
The minimal axial thrust encountered in a double impeller prompted the selection of
a radial type magnetic motor bearing. The cavity (2) is separated into two cavities
(2A, 2B) by a small clearance gap (8A), which is the site for this radial type
magnetic motor bearing.
The coils (11, 12) reside on the outside of the pump housing, and couple to
permanent driver magnets embedded in the cylindrical circumference of the impeller.
This magnetic bearing provides contact free impeller suspension in the radial (x,y)
directions, as well as rotational torque.

6-6

Figure 6-4 Exploded View of Bi-VAD Design

6-7
6.3 Bi-VAD
The current technique used to address bi-ventricular assistance involves the
implantation and operation of two separate pumps. This results in increased size and
control complexity arising from the need to control two independent pumps for left
and right assistance. Attempts to create a single rotary centrifugal device Bi-VAD
are troubled by difficulties in altering the output flow of each cavity independently,
since the impeller has a common rotational speed. Preventing leakage from the high
pressure left cavity to the low pressure right cavity also hinders their operation.
The design shown in Figure 6-4 and further detailed in Appendix G provides
techniques to address these limitations. To summarise, left and right relative flow
variation is achieved from each impeller side by axially actuating the impeller within
the pump cavity. This technique effectively increases the hydraulic efficiency of one
side of the impeller while reducing it on the other. The consequence is a variation in
flow from either side of the pump. Leakage is minimised by incorporating a radial
journal bearing and small clearance gap between the left and right cavities.
Magnetic motor bearing technology is selected to suspend and drive the impeller,
thus overcoming conventional pump limitations of friction and wear at the drive
shaft, seal and bearing interface. Since there is no wear between the moving parts, it
will also greatly increase the durability of the pump and reduce both heat generation
and inherent damage to red blood cells at this interface. This suspension technique
also allows for reductions in rotational speed in response to ventricular collapse.
The pump is designed to augment the function of both the left and right cardiac
chambers, whereby a double-sided impeller provides the function of a bi- ventricular
assist device (Bi-VAD). When inserted into the cardiovascular circuit, the pump is
essentially two separate pumps in operating in series. The pump has a single
rotational speed and the difference in pressure is achieved by incorporating different
impeller vane diameters and profiles on the left and right sides.
The double-sided impeller configuration also eliminates areas of low flow or
stagnation often found beneath conventional single-sided centrifugal blood pumps,
significantly reducing the potential for thromboembolic events.
6-8

Figure 6-5 Bi-VAD Cross Sectional View

Figure 6-6 Bi-VAD Perspective
6-9
Overview
The following description refers to the detailed cross section (Figure 6-5) and
perspective (Figure 6-6) views of the Bi-VAD design.
The pump includes a housing and cavity (102) containing a double sided impeller
(103). The impeller has two set of vanes (104A, 104B).
The housing includes a clearance gap (108) between the casing and the impeller,
which effectively splits the cavity into two cavities (102A, 102B), and reduces fluid
flow between the high and low pressure cavities. The design effectively describes
two pumps defined by the cavities (102A) and (102B).
The impeller is rotated about its axis, causing a flow of fluid from each respective
inlet (105A, 105B) towards each respective outlet (106A, 106B) via volute collection
casings.
Rotation and position of the impeller within the pump cavity is controlled by an axial
magnetic bearing configuration. This type enables the counteraction of greater forces
in the axial direction caused by the imbalance of pressure from the left to right
cavities. Furthermore, an axial magnetic bearing allows impeller axial actuation in
order to alter efficiency and thus output flow rate from each side.
The magnetic fields generated by two sets of coils (111A, 111B), wound on
respective stators (115A, 115B), are coupled to driver magnets (109) embedded
beneath the impeller vanes (102A) and an iron core (151) within the impeller body.
This form of pump assembly can provide either assistance or replacement of both
ventricles of a failing heart. This is achieved by connecting the inlet (105A) of the
pump to either the left ventricle or atrium and the outlet (106A) to the aorta, thus
assisting the natural function of the left heart by improving flow to 5 L/min at
100mmHg. The inlet (105B) is connected to the right ventricle/atrium with the outlet
(106B) connected to the pulmonary artery, thus providing right heart assistance by
improving perfusion to 5 L/min at 20mmHg. In combination, the device functions to
assist both ventricles of a failing heart.

Chapter 7 Conclusions and Future Research
7-1
Chapter 7
Conclusions and Future Research

This thesis is concluded by addressing the aims and summarizing the conclusions
drawn from each section of research. A number of possible avenues for future
research are then identified.

7.1 Conclusions
The main objective of this thesis was to present the progressive design,
development and evaluation of two novel centrifugal type ventricular assist
devices. Completion of this goal was assisted by a comprehensive review of the
literature and inclusion of background research, which provided critical
information for VAD design consideration. A suitable mock circulation testing
facility was then developed to evaluate each prototype pump, designed with a
customised procedure. This evaluation of prototype performance provided
comparative information between each pump impeller/volute configuration,
allowing for the critical selection of pump features to address the outlined design
criteria. The subsequent investigation on hydraulic force characteristics in the
pulsatile mock circulation environment was essential to assist the future design
of the impeller hydrodynamic and magnetic bearing suspension technique.
Finally, due consideration was given to the results obtained within the thesis, in
order to discuss possible Bi-LVAD and Bi-VAD configurations, and their impact
on the considerations for design.
7-2
7.1.1 Literature Review
The review of the literature successfully demonstrated the growing need for
continued VAD research, the important criteria for consideration in new designs,
and the incidence / cause of RHF to support the development of Bi-Ventricular
assistance. Finally, a description of current mechanical devices available for
ventricular assistance is provided, detailing their characteristics and methods for
operation, for which the third generation technique of complete suspension of a
rotary impeller was advocated.
The included background flow visualisation and magnetic bearing research
highlighted additional features for consideration when attempting to develop a
centrifugal VAD. The former study identified regions within a centrifugal pump
that should be carefully designed to reduce the potential for blood trauma; while
the latter study investigated each configuration of radial lorenz type self bearing
motors for potential application into the final VAD designs.
7.1.2 Mock Circulation Loop
The newly developed mock circulation loop was successful at recreating the
pulmonary and systemic hemodynamics expected from a normal and failing heart
at rest. Physiological pressure and perfusion was manufactured and maintained
by pneumatic ventricular chambers and appropriate vascular parameters
respectively. Each ventricular chamber demonstrated the Frank-Starling response
to variations in preload. The desired simulated conditions were produced by
independently and variably controlled left and/or right ventricular function, and
easily varied vascular parameters. The SIMULINK computer model validated the
physical design in regards to vascular pressures and perfusion rates under all
tested conditions, with differences in system order accounting for discrepancies.
The mock circulation rig can be used as a cost effective process to evaluate the
hemodynamic impact of left-, right- and bi- ventricular assist devices on the
circulatory system.
7-3
7.1.3 Centrifugal VAD Design and Development
The customized centrifugal pump design procedure facilitated the efficient and
timely design of VAD iterations. A number of single sided impeller and volute
configurations were designed with this procedure for potential inclusion in each
VAD. These iterations were inserted into the mock circulation loop configured
for both non-pulsatile and pulsatile operation to identify their performance and
hydraulic force characteristics.
7.1.4 VAD Experimental Evaluation
Comparisons were drawn relating to characteristic performance and efficiency in
the non-pulsatile environment. Despite exhibiting lower efficiencies, impellers
with higher discharge angles are recommended, as they created a flatter pump
characteristic curve which assists the physiological control of the device. The
single volute experienced the highest efficiency at the design point; however the
double volute was more efficient at off design conditions. The ability to
manipulate these efficiencies was found with impeller axial actuation. By using
this technique, impeller efficiency would alter as the clearance above the
impeller was changed, an effect pronounced in semi-open impellers
incorporating small blade heights. When inserted into the loop configured for left
heart failure, the LVAD demonstrated the ability to reduced pulmonary
congestion and re-establish hemodynamics from pathological to normal values.
Interestingly, the pump operated along the non-pulsatile characteristic curve in
this diminished pulsatile environment, with the exact operating point
corresponding to the instantaneous pressure differential from ventricle to aorta.
Third generation magnetic bearing technology requires the knowledge of precise
loads for successful impeller suspension. Recording hydraulic thrust during
pump operation helped quantify the exact force requirements of the bearing
system to minimise impeller touchdown. A unique method of measuring these
forces was successfully developed using a multi-axis force transducer. Values
obtained for each impeller and volute configuration operated in the non-pulsatile
environment were found to relate to those recorded in the pulsatile LHF
environment. The non-pulsatile measurements were successfully matched to
specific author empirical formula for axial and radial thrust.
7-4
These hydraulic force findings allow the bearing designer to select the most
appropriate impeller/volute configuration to improve stability in hydrodynamic,
minimise magnetic power requirements of the magnetic, and improve the wear
lifetime of the mechanical type bearing. Ultimately, bearing suspension stiffness
may be designed to minimise impeller touchdown in each actively or passively
supported DOF. The information was used to recommend the most appropriate
configuration for each magnetic bearing investigated for VAD application.
7.1.5 VAD Design Detail
The Bi-LVAD and Bi-VAD presented in this thesis can accommodate the cardiac
patient population requiring either left ventricular or bi-ventricular assistance.
The Bi-LVAD double impeller would improve magnetic suspension capacity,
and reduce complications of thrombosis. The Bi-VAD device would improve the
access of bi-ventricular assistance to smaller patients, as the single device is
smaller than the present technique of implanting separate LVAD and RVAD
pumps.
Vanes on both sides of the double Bi-LVAD impeller were designed
symmetrically to produce the same pressure at outlet, as these outlets must join to
supply the aorta. Impeller force measurements revealed significant reductions in
axial thrust force encountered by this double impeller. This feature would
improve axial touchdown capacity in the axial direction when employing the
recommended slotted type radial magnetic bearing. This configuration would
provide greater capacity to counter transient radial loads, while a double volute
configuration would reduce the static load and thus bearing power requirements.
The left and right sides of the Bi-VAD impeller are responsible for supporting
the respective left and right ventricles. The common speed double impeller vane
lengths are therefore designed to deliver the required pressure for each system.
The anticipated axial force produced by the unbalanced pressure distribution
from left and right impellers prompted the selection of an axial magnetic motor-
bearing. This configuration must be modified to provide precise axial control and
actuation. Axial actuation of the impeller toward the left and right chambers
manipulates respective pump efficiency, and is crucial for the Bi-VAD to
momentarily output different flow rates from left and right sides.
7-5
7.2 Future Research
A number of possible avenues for future research identified within each section
are described below.
7.2.1 Mock Circulation Loop
The mock circulation loop was successful in recreating the hemodynamics of
normal and heart failure conditions at rest. However, a number of avenues for
future research and development are provided to potentially improve the
performance of the system.
Experimental Mock Circulation Rig
Further enhancements of the mock circulation rig include the use of
suitable fluid, with the potential for the introduction of a blood analogue
realised with suitable piping material.
Replacement of the heart valves with artificial mechanical or cultivated
tissue valves can potentially assess their performance in-vitro.
Furthermore, rubber mounting these valves would reduce the pressure
surges experienced upon valve closure.
The inability of the complete rig to simulate the exercise condition would
be overcome by incorporating a larger area flow meter and pinch valve in
the pulmonary system.
Suitable shunts should be included to recreate the bronchial shunt as well
as introduce ventricular or atrial septal defects.
Incorporation of a floating ball within the ventricular chamber would
prevent ventricular function in cases of low preload, thus returning
preload to normal values due to the Frank-Starling effect.
Finally, future investigations should centre on changing method of heart
functionality reproduction to more closely match the native ejection
characteristics,. It is however important to incorporate passive filling
functionality that does not rely on a negative ventricular pressure to
induce flow into the chamber. This goal also involves the correct
matching of vascular impedance, which requires the correct sizing of
vascular piping, compliance chambers and resistances. Furthermore,
7-6
incorporation of a flexible membrane of sufficient compliance within, or
as a replacement to, the current ventricular chamber would allow for the
recreation of ventricular collapse in response to excessive VAD
assistance.
Simulation Model
Modelling the system as a seconder order RLC equivalent circuit by
adding inertiance will add to model completeness, and result in closer
result comparisons to the mock circulation loop.
The simulation model can be expanded to include the VAD as a pressure
source. The experimentally measured pumping characteristics can be
incorporated to determine the level of output flow with regard to values
of preload and afterload.

7-7
7.2.2 Centrifugal VAD Development
A number of areas of the impeller design, force and performance research
presented may be expanded with future research. A few tasks are discussed
below.
Re-design the impeller and volute for best efficiency at a capacity above
expected operating conditions (eg 7 L/min). This also allows the device to
operate at higher physiological flow rates required for exercise conditions
for a given rotational speed.
Redesign the radial 90 degree impeller with a larger exit blade height
Design for a left impeller outer diameter of 40mm to better match the
volute angle with impeller discharge angle, while maintaining a reduced
overall device size.
Test force and performance characteristics of the current Bi-LVAD
iteration.
Test all current Bi-VAD iterations under various conditions of left and
right heart function.
Redesign right impeller of the Bi-VAD for improved performance.
Reduce blade number to minimise flow blockage. Increase impeller outlet
diameter.
Investigate the influence of inlet volute with respect to inlet pre-whirl,
and the potential reduction of output head.
Incorporate a method of mechanical impeller axial actuation prior to
magnetic bearing development to determine applicability of the technique
to vary left and right outflow at a constant RPM. This may be achieved
via the use of appropriately mounted micrometers.
Appendix

Appendix

Appendix A - A Survey of Current Mechanical Assist Devices
Appendix B - Centrifugal VAD Design
Appendix C - Impeller Hydraulic Force Calculation
Appendix D - SIMULINK and MATLAB Code
Appendix E - Calibrations
Appendix F - Magnetic Bearing Investigation
Appendix G - VAD Design Detail
Note: All appendices are provided on the accompanying CD-ROM
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Design, Development and Evaluation of

Centrifugal Ventricular Assist Devices

Specific Head (hs) Vs Specific Capacity (qs)

LVAD Insertion Point

Flow Rate (L/min)

Flow Rate (L/min)

Diastole & Systole

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