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Negative pressure device for intra-abdominal pressure reduction

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2007 J. Phys.: Conf. Ser. 90 012035
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16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

Negativepressuredeviceforintraabdominalpressure
reduction
MDavid,DGeido,FPracca,GSnchez,FSimini,CZoppolo
NcleodeIngenieraBiomdica,UniversidaddelaRepblicaO.delUruguay
HospitaldeClnicas,Av.ItaliaS/N,11600,MontevideoUY
Email:marcelod@cin.edu.uy
Abstract. A device that generates negative extraabdominal pressure (ABDOPRE) for
treatmentofpatientswithhighintraabdominalpressurewasdeveloped.Itincludespressure
sensorsfortransducingintraabdominalpressurethroughanintravesicalcatheterandnegative
pressureinthevacuumbellwhichisplacedovertheabdomen.Bymeansofacontrolsystem,a
patternforreducingIAPisset,accordingtoaclinicalprotocol.Theexternalnegativepressure
isgeneratedusingavacuumpumpconnectedtothebell.Thesystemregistersthevaluesof
interestforthemedicalhistory.ThesystemisbeingtestedoverICUpatients,registeringa
satisfactoryIAPreduction.

1.Introduction
Since2000,interestinICUpatients'IAP(intraabdominalpressure)hasrisenduetothefactthatearly
treatmentofhighIAPhasproventoimprovesaidpatients'evolution[1].However,thisinterestcanbe
tracedbackto1858andto1882whenMossoandPelacani[4]usedavesicalcatheterforthefirsttime.
Numerouspublicationsonthesubjectappearedduringthe1980sanditsimportanceisbackedbyan
exponential growth during the 1990s. Although the etiology of IAP and its relation to the Acute
Compartment Syndrome (ACS) are gradually being studied, definitions on IAP degrees have been
discussedininternationalconsensusessince2004[2].IAPabove10mmHgcausesalterationsinveins'
and arteries' flow but without clinical manifestations. If IAP is kept above 20 mmHg, it affects
abdominal organs with diverse complications which can be avoided by means of abdominal
decompression,surgerybeingapossibletreatment.
Wehavesetforourselvesthegoalofachievingsimilarresultsinalesstraumaticwayforthepatient
bymeansofcontrolledapplicationofnegativepressureonthepatient'sabdomen.Inordertomeasure
and control IAP, we used Kron's intravesical catheter (1983) published by Iberti [5] and recently
modifiedbyCheathamin1998[6].Thevolumeofinfusioninthecatheter(Foley)variesfrom50to100
mlofsalineserum,althoughrecentnormsmentiononly25ml[2].Despitetheconceptbeingfamiliar

c 2007 IOP Publishing Ltd



16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

amongclinicians,atthetimethispaperwaswritten,documentationonattemptsofreducingIAPby
meansofnegativeexternalpressurewasstillscarce.Inthelastthreeyears,somepapersaboutnegative
external pressure applicationhavebeen published [8]; butnone of themdeals withcontrolled IAP
reduction avoiding the negative effects of fast IAP reduction. Therefore, ABDOPRE constitutes an
originalcontributionasanewclinicalinstrumentforcontrolledreductionofhighIAP,whichalsohelps
researchersdeepeningthestudyofIAP'sandACS'sphysiopathology.
2.Methodsandmaterials
The abdomen is considered as a compartment filled mostly with incompressible liquids and gases.
AccordingtoPascal'slawitisdeducedthatthepressureishomogeneousinthewholecompartment.
Therefore,andfollowingcurrentclinicalpractice,IAPwillbemeasuredbymeansofanintravesical
catheterconnectedtoathreeroutekey,forurineevacuation[2].
ThemaincomponentofthecontrolsystemisaPICmicrocontroller,whichisoptimizedforcontrol
operations.Thepressuresofinterestaremeasuredbyatransducerwhichoutputisamplifiedusingan
instrumentationamplifier.ThissignalisdigitalizedbythePIC'sA/Dconverter.ThePICsendthisdigital
signaltoaPCinrealtime,whereacontrollogicisimplemented.ThenthePCcommandsthePICto
handletheperipherals(pump,alarm).
Since medical grade power sources have mostly DC output voltages, for simplicity the used
transducersarepiezoelectric.AsIAPandbellpressuresshouldbemeasuredrelativelywithatmospheric
pressure,differentialtransducersarepreferred;bell'stransducershouldworkinarangeof0to100
mmHg, while IAP's transducer in a range of 0 to +40 mmHg [1] and should be compatible with
physiologicserum.Afterstudyingvariouspossibilitiesandmarketavailability,thechosentransducers
wereHoneywell143PC03Dforbothbell'sandIAP'spressure.

Figure1.ABDOPRE'sblockdiagram.
ThePICisrequiredtohaveatleasttwoA/Dconverters,digitaloutputsandinputsforhandlingthe
pumpandalarmsandanintegratedserialcommunicationblock,forconnectingtothePC.APICwith
internaloscillatorwaspreferredforsimplicity.Bothprogrammeanddatamemoryaresmallenoughtofit
anyPICinthemarket.PIC16F690wasselectedduetoavailabilityinUruguay'smarket.
Infigure1thesystem'sblockdiagramisshown.

16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

2.1.Controlsystem
Afirstapproachtothesolutionoftheproblemaimstodeterminetheparametersofthetheoretical
model,soastocontrolthesystemonthebasisofapredictionoftheevolutionoftheIAPintime.
Nevertheless,theperturbationsinthesignalduetoelectronicnoisemaketheparameterstochangetheir
valuessignificantly,preventingagoodcontrolofthesystem.
AsimpleroptionconsistsonapproximatingtheevolutionoftheIAPbyastraightlineandadjusting
thedutycycleofthevacuumpump.Althoughthisapproximationiscorrectforshortperiodsoftime,the
variationoftheslopesfordifferentdutycyclesofthevacuumbombletseeaninstabilityofthesystem,
tendingtoturnonthepumpforalongerperiodoftimeatthebeginningofthetreatmentthanattheend
ofit.Thisentailstheneedtodiminishthepressureinthebell'scompartmentinasingledutycycle3to4
mmHg.
Finallyitwasdecidedtouseasdefinitiveroutineofcontrolthefollowupofareductionpattern,
whichissimplerandstable.ThismeansthatthevalueoftheIAPiscontrolledintimeandspace,by
applyinganexternalnegativepressure.Foreverymomenttintime,themaximumvalueandminimum
"acceptable"valueforIAParedefinedas"IAPtolerance".Thecontrolisdoneturningthepumponand
off in correspondence with the measured value of real IAP in a certain time t. This method is
independent of the possible leaks (inevitable) that may occur. It also allows choosing the wanted
evolutionfortheIAPintime.Ineverycase,afterreachingthereducedvalueofIAP,theobjectiveisto
maintainitduringalongperiodoftime.
2.2.Projectofthevacuumbell
Thevacuumbellisadevicetobeplacedupontheabdomenofthepatient,coveringitinallitssurface,in
ordertogenerateanegativepressureincomparisontotheatmosphericpressure,tomanagetodiminish
theIAP.
Itmustbemadeofasufficientlyrigidmaterialsothatitcansupportthedifferentialpressurewithout
anydeformation.Thebellcompartmentmusthavealightweightsoastonotbotherthepatientandavoid
increasingtheIAP,inrestsituation.Itmustalsohavearightheightsothatitdoesnotinterferewith
otherexistinginstrumentsintheterminalcarefacilities,andalsotoimproveitsstorageanditsand
positioning.

Figure2.Vacuum'sbellphoto.
Inordertobeabletoobservetheevolutionoftheabdomen,whichisbeingintervened,therewere
consideredaspossiblematerialstomakethebellthosewhichhadcertaintransparency.Thecontactwith

16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

thepatientmustbehypoallergenicandmustnotdoanyhurt.Acurvedcontactinashapesimilartoan
eyelashorasnailorarubbercontactwithcurvaturewereconsidered.Duetothedifficultytomakethe
curvedcontact,theoptionofarubberwithcurvaturewasthechosenone.Thehoseconnectorsforthe
vacuumpumpandthepressuregaugeortransducer,mustbeplacedinacomfortableplaceforitsuse.So
itwasdecidedtoplacetheminthezoneofthebellcompartmentnearthelowerpartoftheabdomen.For
abettermanipulationofthebellcompartment,ahandlewasplacedatthetopasshowninfigure2.
2.3.Bellfittingontopatient'sabdomen
InordertofitABDOPREontopatientsabdomenitisnecessarytohaveanelementforvisualfeedback,
whichindicatesthenursewhetherthevacuumisbeinggeneratedorifthebell'spositionneedstobe
improved.IntheGUIapositioningprotocolisdefined.Itconsistsinevacuatingairfrominsidethebell
andmeasuringtheresultingpressure.Ifsuchpressureislowerthancertainthreshold,agreenimageis
shown,whereasthenonairtightnessofthecontactisindicatedbyaredimage.
2.4.Documentationandclinicalprotocol
ABDOPREoffersthepossibilityofsettingthetreatment'sprotocoltobeappliedoverthepatient.This
protocolisdefinedbythedoctorusingtheGUIspecifyingthefollowingparameters:
1. DesiredvaluesfortheIAP(valueorcurve)
2. IAPtolerance(e.g.0.4mmHg)
3. Timingforthetreatment
4. Instructionsattheending(restarttheprotocolorstop)
ABDOPRE records the evolution of the patients IAP in a graph, together with the therapeutic
objective,inordertoverify,ateverymoment,thecorrectbehaviorofthesystem.Theevolutionis
representedinadetailedscale(30cm/min)andinatendencygraph(1cm/h),thereadingofwhich
allows ensuring the quality of the treatment. At the end of each protocol, ABDOPRE generates a
documentforthepatientsclinicalrecord.Patientsdataarefollowedbythenameoftheprotocol,its
startingandendingtimes,andagraphoftherealIAPtogetherwiththedesiredIAP.
3.Results
Inordertorealizethetestingforthewholesystem(controlsystemandbell),aphantomwithsome
abdomencharacteristicswasconstructed.Thephantom'sshapeissothatitfitsthevacuumbell.This
designpermitscompressibleobjectbehavioursimilartothedevelopedabdomenmodel.Inthefirst
monthsofyear2007,ABDOPREwastestedwiththisphantomreachingamaximumintraphantom
pressurereductionof12mmHg.Areductionpatternandinstantintraphantompressuregraphisshown
infigure3.
TheclinicalperformancewillbeevaluatedbyapplyingABDOPREtoabouttwentyICUpatients.
Theprotocolusedfollowsthefollowingparameters:i)IAPwillbereduceddowntonormalIAPforICU
ventilatedpatients;ii)thereductiontimewillbearound20minutes;iii)IAPwillbemaintainedreduced
forseveralhours.ClinicaltestofABDOPREstartedtotakeplaceinAugustandtheteamisaimingto
keeptestingittoevaluateitsperformance.
System's safety for medical application involves several aspects. It is mandatory to follow the
normativeforleakagecurrents.ItisalsoneededtodemonstratethatABDOPREisstableanditscontrol
systemwillnotproduceanyharmfulbehaviourforthepatient.

16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

Figure 3 . Intraphantom pressure time evolution applying a

reductionpattern.
MeasuredleakagecurrentsmustbelowerthanthemaximumallowedbyIEC606011specifications
formicroshockcurrents(10uA).InordertoensurethisABDOPREisdesigntobeconnectedtoa
medicalgradeDCpowersupply.Maximummeasuredleakagecurrentsareabout1uA.
4.Conclusions
AprototypeforreducingIAP,basedonanautomaticcontrolsystemwhichmeasuresitthroughacatheter
was developed. The specifications were agreed directly with the medical team, who conceived the
apparatusandwilluseitinordertosatisfyitsneedfortreatment.Sincenotechnicalspecificationsfrom
similarequipmentwerefound,theprojectsetthechallengeofgettingintoanunknownterritory.
TheprojectofABDOPREwasdevelopedwithintheuniversityenvironment,inclosecollaboration
withthemedicalteam,whichgivesitthepracticalitythatotherwisewouldnothavehad.Incasethatthe
clinicalapplicationofABDOPREturnssuccessful,itwillmakeavailabletoHealthInstitutionsareliable
equipmentforreducingIAPandforthetreatmentofACSsyndrome.Oncetheequipmentgetsthe
approvalfromsanitaryauthorities,itaimstogetatechnologicaltransfertotheindustry.
Acknowledgements
TheauthorsacknowledgeProf.MDMarioCancela,HeadofClnicasHospitalMedicineDepartmentfor
his support to this project. Adj. Prof. MD Alberto Biestro from the same department is also
acknowledgedforhiscontributionstotheresearch.TheauthorsthankIndustrialDesignSchooldirected
byArch.JaimeSzternforitscooperationandspeciallytoProf.RalArbiza.
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Trauma45:pp597609

16th Argentine Bioengineering Congress and the 5th Conference of Clinical Engineering
IOP Publishing
Journal of Physics: Conference Series 90 (2007) 012035
doi:10.1088/1742-6596/90/1/012035

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