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MPMD
TM
www.asminternational.org/amp
JANUARY 2009
TECHNICAL
AND
BUSINESS
NEWS
FOR THE
MEDICAL
DEVICE
INDUSTRY
Medical Device
Materials
Industry
News
MPMDNEWS.qxp
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JANUARY 2009
TM
Editorial Staff
Margaret W. Hunt
Editor
peg.hunt@asminternational.org
Eileen De Guire
Managing Editor
Eileen.deguire@
asminternational.org
FEATURES
Trisha McKay
Contributing Editor
Barbara L. Brody
SPECIAL REPORT ON
MEDICAL DEVICE
MATERIALS
FROM THE FOLLOWING
SUPPLIERS:
Art Director
Joanne Miller
Production Manager
joanne.miller@
asminternational.org
Joseph M. Zion
Publisher
joe.zion@asminternational.org
Please send news releases to
magazines@
asminternational.org
Editorial Committee
Roger Narayan
North Carolina State University
and the University of North
Carolina, Chair
Ishaq Haider
BD Techologies
Harold Pillsbury
University of North Carolina
Ray Harshbarger
Walter Reed Army Medical Center
Sebastien Henry
Porex
The MPMD Editorial Committee is
strictly an advisory group,
and membership on the
committee in no way implies
endorsement of any of the
publications content.
Sales Staff
Kelly Thomas, CEM.CEP
National Account Manager
Materials Park, Ohio
tel: 440/338-1733
e-mail: kelly.thomas@
asminternational.org
On the Cover
This image from Buehler Ltd. is a
photomicrograph of a section of an
acetabular cup. It shows the Ti-6Al4V substrate and a coating that consists of commercially pure titanium
powder and tantalum beads.
The Ta beads are made by taking
polyurethane foam and volatilizing it
to break down the hydrocarbons and
form a reticulated vitreous carbon
(RVC) foam. This pure carbon foam
is crushed to powder and then
coated with tantalum by chemical
vapor deposition to form the beads.
To make the coating, titanium
powder and a polymer binder are
mixed together and combined with
the tantalum beads on the titanium
alloy substrate. The coating is then
sintered, evaporating the binder. The
titanium mechanically locks the tantalum beads in place, and forms a
metallurgical bond between the
coating and the substrate.
www.buehler.com
ATI Medical
Buehler Ltd.
Carpenter
Technology Corp.
CoorsTek Inc.
Sandvik Bioline
Ulbrich Stainless
Steels and Special
Metals Inc.
DEPARTMENTS
Industry News
Products and Services
2
11
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INDUSTRY NEWS
Cobalt-chromium stent carries drugs in hundreds of reservoirs
A cobalt-chromium reservoir-based stent design that incorporates
hundreds of small reservoirs, each acting as a depot into which drugpolymer compositions are loaded, has been announced by Cordis
Corp., Warren, N.J. The Nevo Sirolimus-eluting Coronary Stent allows drug delivery from an implant surface that is 75% polymer-free
bare metal upon insertion. It becomes fully bare metal following drug
delivery and polymer bioresorption in approximately three months.
The technology also greatly enhances control of the rate and direction of drug delivery, enabling a
wider range of drug therapies to
be delivered, and potentially increases the range of clinical applications of drug-eluting stents and
other drug-device combinations.
For more information: Christopher Allman , Cordis Corp., 7 Powderhorn Drive, Warren, NJ 07059;
tel: 908/412-3223; www.cordis.com.
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INDUSTRY NEWS
Nitinol now available in continuous sheet form
Continuous Nitinol sheet is now available from
Nitinol Devices & Components, Fremont, Calif.
Sheets of thickness from 0.003 to 0.020 inches, in
widths up to 3.0 inches, are supplied on spools or
cut to length. This sheet has the tightest gauge tolerances in the industry (typically 0.0003 in. or
better). Continuous sheet is ideal for laser cutting,
etching, stamping, and EDM machining. A smooth,
light oxide surface allows for efficient processing
and surface finishing.
Tensile properties for superelastic material (Af<
15C): UTS: 155 ksi min; UP: 55 ksi min; elong: 10%
min; perm. set: 0.5% max , after 6% strain. Material
is in stock in various gauge sizes.
For more information: Nitinol Devices & Components, 47621 Westinghouse Drive, Fremont, CA
94539; tel: 510/623-5996; www.ndc.info.
Zirconia-toughened alumina
reinforced with platelets
A zirconia-toughened, platelet-reinforced alumina ceramic designed to incorporate the wear
properties and stability of alumina with vastly improved material strength and toughness has report-
Powders
you can trust.
MIM
HIP
PTA
Braze
Laser
Rapid Prototyping
Thermal Spray
PM Millforms
www.cartech.com
47
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INDUSTRY NEWS
alloy powder for artificial joints is under development at the DOE Ames
Laboratory, Ames, Iowa. Led by Iver Andersen, the research team has already developed and patented a special pouring tube that can stand up
to molten titanium, and has developed the atomization technology for
converting molten metal into titanium powder. That could mean titanium joints, which can resist corrosion for the lifetime of a patient, could
be affordable enough to replace stainless steel joints, which are commonly
used today but can corrode after five years.
A grant from the U.S. Department of Energy and
the Iowa State University Research Foundation will
help build a prototype atomizer to produce the titanium alloy powder. The alloys and processing
technology could lead to establishment of a new
company, Iowa Powder Atomization Technologies,
which might serve as the basis for a biomedical
manufacturing industry in Iowa.
For more information: Iver Anderson, Ames
Laboratory, Ames, IA 50011; tel: 515/294-9791;
andersoni@ameslab.gov; www.ameslab.gov.
Fatigue Equipment:
ISO/IEC 17025:2005(E)
Certified
Certificate # 2422.01
ISO/IEC 17025
testing@accutektesting.com
Ph: 513-984-4112 Fax: 513-984-8258
www.accutektesting.com
48
Nanocrystalline hydroxyapatite
granules fill scaffold with bone
Nanocrystalline hydroxyapatite granules in collagen
biopolymer encourage bone ingrowth, reports Pioneer
Surgical Technology Inc., Marquette, Mich. FortrOss bone
void filler for orthopaedic applications is a scaffold for
the in-growth of new bone when superior bone regeneration is required.
The FortrOss bone void filler combines the nanotechnology of NanOss hydroxyapatite with the bone growth
promotion of E-Matrix scaffold, a sterile, injectable collagen biopolymer designed to repair or regenerate diseased or damaged tissue. The FortrOss osteoconductive
matrix utilizes Pioneers NanOss technology and is designed to mimic the nanostructures in bone tissue.
For more information: Pioneer Surgical Technology, 375
River Park Circle, Marquette, MI 49855; tel: 906/226-9909;
www.pionersurgical.com.
ADVANCED MATERIALS & PROCESSES/JANUARY 2009
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INDUSTRY NEWS
Nitinol/stainless steel tubing welded for delivery shafts
Creganna Medical Devices introduces Fusion Technology for Nitinol
to Stainless Steel tube joining. A patented breakthrough welding solution enables combining the unique attributes of Nitinol with the
trackability of stainless steel for a cost-effective product design. Nitinol
offers a unique range of characteristics when designing medical device delivery shafts including superelastic and shape memory behavior, superb crush resistance, and flexibility.
When designers choose Nitinol
tubing for catheter design, it is typically in the distal section of the
shaft that the unique attributes of
the metal are important. By using
Nitinol in the distal section only,
and an economical metal tube for
the proximal section, designers can
optimize both the performance
and cost of the overall design. Cregannas unique technology
demonstrates a strong weld zone
not achieved by standard welding
technologies or other joining
methods such as bonding, heat
shrinks, or mechanical joining.
For more information: Maura
Leahy, Creganna Medical Devices,
Galway, Ireland; tel: 353 91 757801;
maura.leahy@creganna.com;
www.creganna.com.
Cobalt-chromium rod
designed for spinal implant
Cobalt-chromium rods for the
treatment of complex spinal
pathologies and procedures have
been announced by K2M Inc.,
Leesburg, Va. The Range Rigid
Rod features flexural rigidity properties comparable to 5.5 mm diameter stainless steel and 6.35 mm titanium alloy. Since cobalt
chromium is compatible with titanium, surgeons may have more
intra-operative flexibility with various rod offerings in one system.
Also, the cobalt-chromium material is more MRI compatible than
stainless steel. The rod provides
increased construct rigidity while
maintaining the low profile of the
taper-lock implant design.
For more information: K2M Inc.,
751 Miller Drive SE, Leesburg,
VA 20175; tel: 866/526-4171;
www.k2m.com.
ADVANCED MATERIALS & PROCESSES/JANUARY 2009
49
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ATI
50
Composition
Fe-18Cr-14Ni-2.5Mo
Fe-22Cr-12.5Ni-5Mn-2.5Mo
Co-28Cr-6Mo, Lo-Carb
Co-28Cr-6Mo, Hi-Carb
Co-20Cr-15W-10Ni-1.5Mn
Co-35Ni-20Cr-10Mo
Co-35Ni-20Cr-10Mo, LoTiTM
Ti CP-1
Ti CP-2
Ti CP-4
Ti-3Al-2.5V
Ti-6Al-4V
Ti-6Al-4V ELI
Ti-6Al-7Nb
Ti-15Mo
Ti-12Mo-6Zr-2Fe
Ti-12Mo-6Zr-4Sn
Ti-13Nb-13Zr
Ti-45Nb
Ti-35Zr-10Nb
Ti-35Nb-7Zr-5Ta
Ta CP
Zr-2.5Nb
Ni-45Ti
UNS
S31673
S20910
R31537
R31538
R30605
R30035
R30035
R50250
R50400
R50700
R56320
R56400
R56401
R56700
R58150
R58120
R58030
R58130
R58450
Unassigned
R58350
R05200
R60705
N01555
ASTM/AMS Standard
ASTM F 138
ASTM F 1314
ASTM F 1537, Alloy #1
ASTM F 1537, Alloy #2
ASTM F 90
ASTM F 562
ASTM F 562
ASTM F 67, Grade 1
ASTM F 67, Grade 2
ASTM F 67, Grade 4
ASTM F 2146
ASTM F 1472
ASTM F 136
ASTM F 1295
ASTM F 2066
ASTM F 1813
AMS-T-9046
ASTM F 1713
AMS 4982D
ASTM F 560
ASTM B 550
ASTM F 2063
ISO standard
ISO 5832-1
ISO 5832-12
ISO 5832-12
ISO 5832-5
ISO 5832-6
ISO 5832-6
ISO 5832-2
ISO 5832-2
ISO 5832-2
ISO 5832-3
ISO 5832-3
ISO 5832-11
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Buehler
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Carpenter
process, offers improved wear resistance, finer grain, enhanced forgeability, and superior fatigue strength.
BioDur 108 alloy is a high-nitrogen, essentially nickelfree stainless implant alloy that is capable of developing
mechanical properties well in excess of 200 ksi. This alloy
also demonstrates improved galling resistance when
compared to BioDur 316LS and 22Cr-13Ni-5Mn stainless. Higher strength alloys like BioDur 108 are increasingly specified for more demanding applications.
In addition, Carpenters titanium subsidiary, Dynamet,
has developed titanium Ultrabar products to ultra-tight
dimensional tolerances and exceptional diameter uniformity required for some titanium MIS implants. Ultrabar
is produced in diameters ranging from 3 to 12mm and
lengths up to 14 feet in a variety of implantable titanium
alloys. Diameter tolerance control is down to 0.00015 inch,
depending on size.
SLIC titanium, produced by Dynamet from prestraightened coil, has been used for formed fasteners; and
Ti-15Mo is capable of achieving higher properties, depending on the application.
Currently in development is Ti6Al-4V ELI, CP 4, and
6Al-7Nb precision-rolled flat bar. It provides closer-tofinish tolerances, improved surface finishes, and better
shape consistency. It has the added benefits of enhanced
mechanical properties and improved grain structure compared with parts typically cut from plate.
In addition, customized ultra-high strength conditions
of current stainless alloys are also available, as shown in
the table. Whether the designer needs titanium, cobalt or
stainless as their material solution, options are available
that can provide that customized feel that some surgeons
require.
For more information: L. Anthony Guitterez, Market
Manager Medical Products, at 610/208-3603; aguitterez@
cartech.com. Tom Zuccarini, Market Manager Medical, Dynamet Inc.; tel: 714/229-4153; tzuccarini@cartech.com.
Carpenter Technology Corp. manufactures a variety of innovative alloys that have been used in the global medical devices
market.
Coors
52
0.2% Yield
strength, ksi
125
140
45
110
140
85
140
190
160
Ultimate tensile
strength, ksi
135
160
90
140
180
145
180
230
200
Elongation, %
15
16
50
30
20
52
25
18
28
Reduction in
area, %
45
45
80
70
60
75
70
60
24
Elastic
modulus, ksi
16,500
28,000
30,000
33,000
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Page 11
ical resistance and excellent electrical resistance, especially in high temperature environments all properties
designed to work well in medical device applications.
CeraPure advanced ceramics are available in alumina and
zirconia, both approved for USP Class VI for medical applications. Grades include Alumina FG and CeraPure
Alumina Plus.
CeraPure alumina (aluminum oxide) can be pressed,
extruded, molded, or cast. Resistant to high temperatures,
products are ideal for applications needing medical
sterilization. It is an excellent insulator against electric
currents, provides strong resistance to thermal shock,
and causes little or no reaction in environments with
biomaterials.
CeraPure zirconia-toughened alumina (ZTA) resists
extreme impacts and provides high flexural strength for
components that must bend or pry.
CoorsTek Dura-Z is zirconia partially stabilized with
magnesium, and it offers an even higher level of flexural
strength. Dura-Z zirconia represents a huge performance
gain over competitive materials such as iron and steel,
and is the most fatigue-resistant standard zirconia
available.
CeraPure YTZP (yttria-stabilized tetragonal zirconia
polycrystals) is available in hot isostatically pressed or
sintered forms. Stabilized with yttria, the YTZP provides
excellent chemical resistance in chemically corrosive environments. Its flexural strength is nearly double that
of traditional zirconia-toughened alumina, necessary for
high wear environments.
In addition to advanced ceramics, CoorsTek offers a
line of high-performance plastics for a proprietary line of
energized seals, polymer bearings, and custom precision
parts. These polymers are suitable for applications requiring wear resistance, chemical compatibility, extreme
thermal stability, and low friction.
High-temperature polymers include polyetheretherketone (PEEK), polyetherimide (PEI), and polyethersulfone (PES). Fluoropolymers, including polytetrafluoroethylene (PTFE, also known by DuPonts tradename, Teflon),
exhibit the lowest coefficient of friction available. With
excellent dielectric strength and chemical resistance, PTFE
functions well at extreme temperatures. Tetralon, CoorsTek
trademarked PTFE, is virgin material, with the ability to
wear longer than traditional Teflon. Plastics can be enhanced by adding fillers that include graphite, bronze,
glass, or molybdenum disulfide.
CoorsTek provides individually tailored technical assistance through our sales and engineering staff, assisting
in the right selection of materials. Our worldwide manufacturing capabilities support quick-turn prototype development to high-volume production for both our technical ceramic and high-performance plastic components.
For more information: Kalani Fogleman, CoorsTek Inc.,
17750 West 32nd Avenue, Golden, CO 80401; tel: 303/2774654; kfogleman@coostek.com; www.coorstek.com.
Sandvik
Ulbrich
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10
a wide range of other medical quality alloys, including titanium, titanium alloys, nickel alloys, cobalt alloys, and
nitinol.
The versatility of our shaped wire process allows us to
produce net or near-net custom cross-sectional shapes
with compositions and mechanical properties tailored to
meet your specification requirements. Flat rolling and
shape rolling or drawing, with intermediate anneals to
restore properties and control finished properties, allow
us to achieve your custom shape.
With the recent addition of Delta Ulbrich, we can now
offer plated materials such as silver-plated copper mandrels for catheter manufacturing, gold-plated tungsten
fine wire for radiopacity applications, and drawing capabilities for fine wire nitinol and other materials down to
under 0.001-inch round and flat configurations.
Precision strip products are found in a variety of medical applications. Our controlled atmosphere annealing
lines work in tandem with the rolling process to produce
exacting mechanical properties as well as maintain the required finishes. With the addition of our new UltraLite
Foil line, we can produce materials under 0.0005 inch thick
and up to 14 inches wide.
Our engineering staff can assist in selecting alloys and
formulating a specification, and we can custom produce
small coils or spools for R&D work, or we can produce
full production quantities.
For more information: Todd Hall, Ulbrich Stainless Steel
and Special Metals, 57 Dodge Avenue, North haven, CT 06473;
tel: 502/644-4722; fax: 502/228-4722; thall@ulbrich.com;
www.ulbrich.com.
VE AT
SA D
E
TH
Questions?
Contact us:
ASM International
Event Planner, MPMD 2009
9639 Kinsman Road
Materials Park, Ohio USA 44073-0002
Telephone: 440-338-5151
Fax: 440-338-4634
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At Your
Fingertips
Comprehensive
materials and design
specifications
For complete details
for implanted
and a demonstration, contact
Cardiovascular
raymond.sirochman@asminternational.org
and Orthopaedic
800.336.5152, ext 5576
440.338.5418
devices.
56
Material, costing,
and drug
combinations
Fully linked to full
text FDA references
www.asminternational.org/meddev/
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JOINT COLLABORATION
SPEED TO MARKET
STRATEGIC PARTNERSHIP
Combining scientific research with
practical manufacturing experience,
well give you our total support in
developing the optimal products.
www.smt.sandvik.com/medical
MPMDNEWS.qxp
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your implants.
CAPABILITY, MEET CAPACITY.
When it comes to spinal and extremity
implants, no one matches Norman Nobles
technology, experience and reputation for
quality. Now, with an expansion that includes
eight, 7-axis contour milling machines, no
one takes you from prototype to full-scale
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Tolerances of +/-.0001"
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