prosthetics and orthotics manufacturing guidelines: upper limb prosthetics: trans-humeral prosthesis

8/9/2019 Prosthetics and Orthotics Manufacturing Guidelines: Upper limb Prosthetics: Trans-Humeral Prosthesis

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International Committee of the Red Cross

19 Avenue de la Paix

1202 Geneva, Switzerland

T + 41 22 734 60 01 F + 41 22 733 20 57

E-mail: [email protected]

www.icrc.org

ICRC, September 2006

All photographs: ICRC/PRP


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T of cott

Foreword 2

Introduction 41.Castingandrectication 5

2.Positioningothesocketcuportheelbowunit 6

3.Polypropylenedraping 7

4.Assembly 8

5.Makingthehookcableattachments 9

6.Polypropylenedrapingorcableattachment 11

7.Shapingthecableattachment 12

8.Fixationothehookcableattachments 13

9.Shoulderharness 14

10.Finishedtrans-humeralprosthesis 18

Listocomponents,CREquipmentsSA(CRE) 19

Listoothermanuacturingmaterials 20

Manuact uring Guid el ines Trans-Humeral P rost hesis


4/24 ICRC P hysical Rehab i l i t at ion P rog ramme

Foror

T ICRC poprop tcoo

Sinceitsinceptionin1979,theICRCsPhysicalRehabilitationProgrammehaspromotedtheuseotechnologythatisappropriatetothespeciccontextsinwhichtheorganizationoperates,i.e.,countriesaectedbywarandlow-incomeordevelopingcountries.

Tetechnologymustalsobetailoredtomeettheneedsothephysicallydisabledinthecountriesconcerned.

Tetechnologyadoptedmustthereorebe:

durable,comortable,easyorpatientstouseandmaintain; easyortechnicianstolearn,useandrepair; standardizedbutcompatiblewiththeclimateindierentregionsotheworld; low-costbutmodernandconsistentwithinternationallyacceptedstandards; easilyavailable.

Techoiceotechnologyisogreatimportanceorpromotingsustainablephysicalrehabilitationservices.

Forallthesereasons,theICRCpreerredtodevelopitsowntechniqueinsteadobuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.TecostothematerialsusedinICRCprostheticandorthoticdevices

islowerthanthatothematerialsusedinappliancesassembledromcommercialready-madecomponents.

WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanuacturedlocally.Intheearly1990stheICRCstartedtheprocessostandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,orthesakeoharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityoservicestopatients.

Polypropylene(PP)wasintroducedintoICRCprojectsin1988orthemanuactureoprostheticsockets.Terstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponents

suchasvariousalignmentsystemswererstdevelopedinColombiaandgraduallyimproved.Inparallel,adurableoot,madeinitiallyopolypropyleneandEthylVinylAcetate(EVA),andnowopolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberoot.

In1998,aercareulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertoocusonpatientcareandtrainingopersonnelatcountrylevel.


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Ojctiv of t

TeICRCsManuacturingGuidelinesaredesignedtoprovidetheinormationnecessaryorproductionohigh-qualityassistivedevices.

Temainaimsotheseinormativemanualsareasollows:

opromoteandenhancestandardizationoICRCpolypropylenetechnology; oprovidesupportortrainingintheuseothistechnology; opromotegoodpractice.

Tisisanothersteporwardintheeorttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme


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Itroctio

Tisdocumentdescribesamethodorproductionotrans-humeral prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysical

RehabilitationCentreinBattambang,Cambodia.

Tecasting,recticationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsopracticeandarethereorenotdescribedintheseICRCmanuacturingguidelines.

ICRC P hysical Rehab i l i t at ion P rog ramme



CasTIng and ReCTIF ICaTIOn1

4Patientassessment,castingandrecticationopositivecastimpressionsareperormedinaccordancewithP&O

standards.

4Alignmentlinesantero-posteriorandmedio-lateral(A-P,M-L)aredrawnonthepositivemouldorproperpositioningotheelbowcup.Inmostcases,thiswillbealongthecentralaxisothetrans-humeralstump.

Drivenailsintothedistalendothecasttoensuregoodadherenceorthebuild-upotheplasterextension.



POsITIOnIng OF The sOCkeT CuP FOR The elbOw unIT2

4MakeaconicalextensiontubeusingEVA,plasticsheetingorsomeothersuitablematerialandpositionitaccordingtothe

alignmentlinesortheelbowcup.apetheconeinplaceandllitwithplasteruptothelevelotheproximalendotheelbowcup.

Formeasurementsseeollowingparagraph.

4Prolongtheproximalalignmentlinesalongtheplasterextensioninordertoacilitate

positioningotheelbowcup.

Temeasurementromtheacromiontothelateralepicondyleothesoundside,minusthedistanceromtheelbowaxistothedistalendotheelbowcup,willdeterminethelengthothetrans-humeralsocket.

Driveanailintothedistalpartothebuild-uptoensuregoodadherenceothecup,andxthecupinproperalignmentwithwet

plasterinaccordancewithP&Ostandards(useanalignmenttableiavailable).



POlyPROPylene d RaPIng3

4

Measurementsorpolypropylenesheet:

Cupcircumerence+2cm Acromioncircumerence+5cm Lengthoplastercast+15cm

Ticknessosheet:4mm

Heatthepolypropyleneinanovenorabout20minutesat

180C.

4Beoredrapingthepolypropylenesheet,pullastockingovertheplastermould.Cutitatthe

proximalpartotheelbowcupandxitwithcontactglue.Dustthestockingwithtalcumpowder.

4Drapethepolypropyleneovertheplastermodelandstickthesidestogetheralongthemedial

sideothesocket.ightenthepolypropylenearoundthesuctionconeortubeusingabicycleinnertube,ropeorstocking,thenopenthevacuumvalve.



assembly4

6Removetheplaster,shapethesockettrimlinesandgrindthemedialweldingseam.

Flattenthepolypropyleneonthedistalendotheelbowcup.

Assembletheelbowunitandcuttheorearmaccordingtothemeasurement.Telengthotheorearm,includingthehook,shouldbe1to2cmshorterthanthesoundside.Fixthewristunitwith4panheadPhillipsramingscrews(8x3mm).



4Forthehookcableattachments,duplicatetheoutsidedistalpartothetrans-humeralsocketandtheorearmwithplasterbandages.Fillthetwo

negativeswithplasterandsmooththem.

4Pullstockinetovertheplastermodels.

makIng The hOOk Cable aTTaChmenTs5



4Onthearmmould,placeabicyclebrakecablehousing7cmabovethedistalendotheelbowcupandcurvetheupperpartaccordingtothepositionotheharness.

Ontheorearm,placetheproximalcablehousingdummylaterally,3cmromtheelbowaxis,toallowullfexionotheorearm.Tedistalcablehousingisplacedontheanteriorpartotheorearm,atleast5cmromthewrist,toallowrotationothehook.

4Fixthecablehousingdummiestothestockinetwithcontactglue.

opreventthecablehousingsrombeingfattenedwhendrapingthepolypropylene,insertanelectricwireinthem.

Itispossibletomakeseveralhookcableattachments(e.g.leandright)onthesamemould.



POlyPROPylene dRaPIng FOR Cable aTTaChmenT6

4Drapea3mmpolypropylenesheetoverthearmusingthesamemeasurementsanddraping

techniquesasorthetrans-emoralsocket.

4Whenthepolypropylenehascooled,markthetrimlineso

thehookcableattachmentsandcutwithanoscillatingsaw.



shaPIng The Cable aTTaChmenT7

6Cutandshapethepolypropylenecablexationsandinsertthecablehousingintothechannels.

Drillholescorrespondingtothediameterothetubularrivetsorscrews(seenextparagraph).



FIxaTIOn OF The hOOk Cable aTTaChmenTs8

4Tenishedhookcableattachmentsareplacedinthesamepositionasontheplastermould.

Ontheorearmtheyarexedwithcountersunkheadsel-tappingscrews(d1=3mm,L=10mm).

4Onthetrans-humeralsocket,thehookcableattachmentisalsoplacedinthesamepositionasontheplastermould.

Fixtheattachmentwithtubularrivets(8x9mm).

Shouldthepositionotheattachmentshavetobechanged,warmthemwithaheatgunandmouldthemagainagainstthearmsocketororearm.



shOuldeR haRness9

6Insertthebicyclebrakecableintothehousing.Ontheproximalpart,xawebbinghangerwithascrewclamp.Onthedistalpart,makealoopwiththecableandsecureitwithasmallmetaltube(clampsleeve),whichisfattened(pressed)aroundthecable.

6Tesimplesttypeoharnessoroperatingthehookisthegureoeightsuspension.



4Foldthenylonbeltaroundtheoppositeshoulder.Teconnectionshouldbeadjustedinthemiddleotheback(spine).

4Stapleorclamptheharnesstogether.Whencuttingthebelt,leaveitalittlelongersothatitcanbereadjusted.

Checkwiththeamputeethatthecablecontrolsystemunctionsproperlyindierentarmpositions.

oopenthehook,thepatientmoveshisshoulderonthesoundside(oppositesideordoubleamputees)ortheprosthesisorward.

4

Oncetheharnesshasbeenadjustedsothattheamputeeeelscomortablewithit,sewthebeltconnectionandthexationontothewebbinghanger.



4opreventraying,meltthebresattheendothebeltwithaweldingiron.

4Teharnessisconnectedtothewebbinghangerontheposteriorside,whiletheotherendisxed

totheanteriorwallwithatubularrivet.

Teelasticstrapenablestheamputeetoopenandclosetheworkinghook.



6Otherharnessingsystems,suchasthoseproducedbytheOttoBockCompany,maybeused.



FInIshed TRans-humeRal PROsThesIs10

4Nexttothehookorworkingring,acosmetichandorothertoolrequiredbythepatientmaybeattached(screwedon).


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ICRC Code DescriptionUnit ofmeasure

Quantity

MDREBANDP10

MDREBANDP12

Plaster bandages 10 cmorPlaster bandages 12 cm

According to stump dimension

OMIS Plaster o Paris According to cast dimension

OMIS Nails Each 4

OPLAEVAFERA03OPLAEVAFKIN03OPLAEVAFLIV03

EVA 3 mm, plastic sheet or other or extension tube Each 1, dimension according to TH socketextension length

OMIS Tubular nylon stocking, 60 or 80 mm or PP draping Each 1, length according to TH socket

OMIS Bicycle brake housing dummies with electric cable Each Length described in book cableattachments

OPLAPOLYCHOC04OPLAPOLYCHOC05

OPLAPOLYSKIN04OPLAPOLYSKIN05

OPLAPOLYLIV04OPLAPOLYLIV05

Polypropylene 4 or 5 mm according to patient size:Polypropylene 4 mm, terra brownPolypropylene 5 mm, terra brown

Polypropylene 4 mm, beigePolypropylene 5 mm, beige

Polypropylene 4 mm, olivePolypropylene 5 mm, olive

Each Dimension explained in PP drapingtechnique

OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03

Polypropylene 3 mm or cable attachment dummies:Polypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive

Each

OMIS Defnitive bicycle brake cable with housing Each 1, cut according to patient sizeOMIS Fixation or cable attachment on orearm:Countersunk head sel-tapping screws d1 = 3 mm,L = 10 mm

Each 4

OHDWRIVET081

Fixation or PP cable attachment on trans-emoral socketand harness:Tubular rivets 8 x 9 mm

Each 5

OMIS PP webbing hanger or other fxation method Each 1

OMIS

OCPOELBOHAR

Harness nylon (or other) belt (width 25 mm) with elasticstrap (width 25 mm)orHarness or upper limb prostheses

Each 1, length according to patient size

lit of otr fctri tri


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MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral andindependent organization whose exclusively humanitarian mission is to protect thelives and dignity of victims of war and internal violence and to provide them withassistance. It directs and coordinates the international relief activities conductedby the Movement in situations of conict. It also endeavours to prevent suffering

by promoting and strengthening humanitarian law and universal humanitarianprinciples. Established in 1863, the ICRC is at the origin of the International RedCross and Red Crescent Movement.

Acknowledgements:

Jean Franois GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard Matagne

Joel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan

and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.


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prosthetics and orthotics manufacturing guidelines: upper limb prosthetics: trans-humeral prosthesis

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