prosthetics and orthotics manufacturing guidelines - 1 ... · the icrc’s “manufacturing...

Physical Rehabilitation Programmetrans-Femoral Prosthesis

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Manufacturing guidelines

MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.

Acknowledgements:

Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoestmaHmayak Tarakhchyan

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

International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP

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Table of contents

Foreword 2Introduction 41.Rawmaterialsandcomponents 42.Measurementsandsocketmanufacture 5

2.1Trans-femoralcupalignmentandsocketmanufacture 62.2Total-contactprosthesis 11

3.Buildinguptheprosthesisandbenchalignment 154.Polypropylenecosmeticmanufacture 285.EVAcosmeticmanufacture 38Referencelistofmaterials 41

Manufac tur ing Guidel ines Trans-Femoral Prosthesis

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

Foreword

The ICRC polypropylene technology

Sinceitsinceptionin1979,theICRC’sPhysicalRehabilitationProgrammehaspromotedtheuseoftechnologythatisappropriatetothespecificcontextsinwhichtheorganizationoperates,i.e.,countriesaffectedbywarandlow-incomeordevelopingcountries.

Thetechnologymustalsobetailoredtomeettheneedsofthephysicallydisabledinthecountriesconcerned.

Thetechnologyadoptedmustthereforebe:

• durable,comfortable,easyforpatientstouseandmaintain;• easyfortechnicianstolearn,useandrepair;• standardizedbutcompatiblewiththeclimateindifferentregionsoftheworld;• low-costbutmodernandconsistentwithinternationallyacceptedstandards;• easilyavailable.

Thechoiceoftechnologyisofgreatimportanceforpromotingsustainablephysicalrehabilitationservices.

Forallthesereasons,theICRCpreferredtodevelopitsowntechniqueinsteadofbuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.ThecostofthematerialsusedinICRCprostheticandorthoticdevicesislowerthanthatofthematerialsusedinappliancesassembledfromcommercialready-madecomponents.

WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanufacturedlocally.Intheearly1990stheICRCstartedtheprocessofstandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,forthesakeofharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityofservicestopatients.

Polypropylene(PP)wasintroducedintoICRCprojectsin1988forthemanufactureofprostheticsockets.Thefirstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponentssuchasvariousalignmentsystemswerefirstdevelopedinColombiaandgraduallyimproved.Inparallel,adurablefoot,madeinitiallyofpolypropyleneandEthylVinylAcetate(EVA),andnowofpolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberfoot.

In1998,aftercarefulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertofocusonpatientcareandtrainingofpersonnelatcountrylevel.

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Introduction

Theaimofthisdocumentistodescribeamethodformanufacturingtrans-femoral (TF) prosthesesusingtheICRC’spolypropylenetechnologyasappliedatthePhysicalRehabilitationCentreinAddisAbaba.

Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

Trans-femoralkitsareavailableinadultandchildsizes.

6Contentsofthekit:

� SolidAnkleCushionHeel(SACH)foot� Hexagonal-headboltandlockwasher� Convexankle� Concavecylinderandpin5 Setofwashers,nutandbolt6 Convexdisc7 Conicalcup8 Trans-femoralcup9 Kneeshell

Raw maTeRIals and COmpOnenTs1

5ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

assessment, measurements and casting

measuRemenTs and sOCkeT manuFaCTuRe2

4Thepatientisassessed,aprescriptionismadeandmeasurementsaretakeninaccordancewithbestP&Opractice.

4AnegativecastistakeninaccordancewithusualP&Opractice.

6

2.1 Trans-femoral cup alignment and socket manufacture

4Themouldisfilledtoproducethepositive,whichisrectifiedaccordingtothemeasurementstaken.

4Chamfertheedgeofthetrans-femoralcup.



alignment of the trans-femoral cup

4Coverthemouldwithnylon.

Fixthenailatthebottomofthemould,wherethecupwillbeattached.

PlacetheTFmouldontheCRalignmentjig;alignaccordingtotheinstructionsontheuseofthejig(separatemanual).Makethealignmentinaccordancewiththemeasurementcard.FixthecuptothesocketwithplasterofParis(POP).

4AddapieceofEVAatthedistalpartofthecup.

ThiswillpreventthePPfrombeingdrawninduringsuction.

Itwillalsofacilitateopening.

8

4Cutasheetof5mmPPaccordingtothemeasurements(add5cmtothecircumferenceand10-15cmtothelength).

LeavethePPintheovenataround180°forabout20minutes.

DrapethePPonthemouldandopenthevacuumsuction.


4CutofftheexcessPP.

LeavethevacuumonuntilthePPcoolsdown.

4Waitatleast6hoursbeforeopening.

Drawthetrimlineontheproximalpartofthesocket.

UsetheoscillatingsawtocutthePP.

Removetheplaster.


4GrindthedistalpartofthecupdowntotheEVApad.

UseascrewdrivertoremovetheEVA.

4Grindthedistalpartuntilitisflat. DonotremoveallthePP.

4Checkthatthesurfaceisflat.

4Grindthedistalpartuntilitisflat.

�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

4Grindthesocketalongthetrimlineswiththerouter.

4Useasharppieceofglasstosmooththeedgeofthesocket.

4Usingaconicaldrill,maketheholeforthecottonstockingorforthesuctionvalve.

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6Positionthesuctionvalvemedio-laterallyanddistallytotheplastermould.Usethesuctionvalveringtoshapetheplaster.ReducethediameteroftheplastertoallowforthethicknessofPPused(4or5mm).Smoothitnicelyandbreaktheedge.(see2.1,page6).

2.2 Total-contact prosthesis

Therearetwowaysofmanufacturingatotal-contacttrans-femoralsocket:

1.BythesameprocedureasforaconventionalTF;

2.ByweldingtheconicalcupdirectlyunderthePPsocket.


4Coverthemouldwithanylonstocking.

Fixthecupwithplasterintheusualway.

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3 mm

12 mm6 mm

3 mm

Duringthefirstfitting,glueapieceofEVAinsidethecupinordertoavoidairleakage.

Gluea12mmanda6mmpieceofEVAinsidethecup.Finally,usea3mmpiecetocoverthecupandthesidesofthecup.


6Materialneededforfinishing.

6Gluethe12mmand6mmEVAdiscsinsidethecup.

6Lastly,gluethe3mmEVAallaroundthecup.

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4Drillaholeaccordingtothediameterofthesuctionvalve.


4Smooththeedgewithasharppieceofglass.

4Testthesuctionvalveandcheckbyaddingwaterinsidethesocket.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

4Iftheconicalcupisused,itmustbeadjustedtothesocketinaccordancewiththealignment.

Usetheweldingirontomakeagroovebetweenthesocketandtheconicalcup.

4Usethehot-airweldingguntoweldthecuptothesocket.

Thishastobedoneverycarefullytoavoidbreakageduringthefirstfitting.

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6Componentsfor 6 mm ankle disc only.

ankle-foot alignment

Anextra4mmplatemustbeattachedtotheconvexankle.(For 6 mm ankle disc only.)

DrilltwoholesasshownontheillustrationbelowandfixthetwocomponentstogetherwithaPPweldingrod.(For 6 mm ankle disc only.)

This will prevent breakage of the foot bolt.


The building-up and bench alignment process – steps to follow

• Ankle-footalignment• Socketalignment• Adjustmentoflength• Weldingofcylinders• Alignmentoffinishedprosthesis

6Preparationbeforefixationfor 6 mm ankle disc only.

BuIldIng up The pROsThesIs and BenCh alIgnmenT3

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6Formaximumstrengthoftheassembly,theopeningoftheconcavecylindermustbeinfront,andthereinforcementbarattheback.


6Fixationprocedure.

6Finalresultfor 6 mm ankle disc only.

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Theanklealignmentsystemallowsdorsalandplantarflexion,medio-lateralmovementssothattheprosthesiscanbeadjustedtotheheelheightoftheshoe.

Thealignmentcanbeadjustedforaheelheightofbetween0mmand20mm,butaheelheightof10mmisrecommended.

Theheelheightisadjustedaccordingtothepatient’sshoe;theconcavecylindermust be perpendicular to the ground.


4Thefootisadjustedinexternalrotationsof5°.

4Checkthealignmentonceagainwiththepatient’sshoeonthefoot.

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4Transferthismeasurementfromthefootuptothemechanicalknee-jointaxis.


knee-ankle-foot alignment

6Samemeasurement.

4Themeasurementtakenonthepatientmustbefromthemedialtibialplateauplus1.5to2cmtotheground.

�9ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

4Drawalinewithamarkeraccordingtothemeasurementtaken.

Makeanothermark9cmfromthefirst.Thiscorrespondstothebottomoftheconcavecylinderminus1cm.

4Usethepipecuttertomakethecut.

Smooththeedges.

4Payspecialattentiontotherotationoftheknee-jointwiththefoot.

Heatthedistalpartofthepipewiththehot-airweldinggun.

Usearubbermallettoinserttheknee-jointintotheconcavecylinderasfarasthemark.


socket and bench alignment

length adjustment for normal stump length

Thesocketisconnectedtotheconicalcup(afterlengthadjustment)withaconvexdiscinbetween.Theconicalcupisweldeddirectlyontopofthekneejoint.Theconvexdiscallowsabduction,adduction,flexion,extensionandshiftinginalldirections.

6Checkthealignmentandadjusttheconicalcupaccordingtothemeasurementstaken.

Cup opening in frontCORReCT

Cup opening at backInCORReCT

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis

6Theforcepatternsonheelstrikeareasshownintheseillustrations.Breakagescanhappeneasily.

6Makesuretheconicalcupremainshorizontalinbothplanesbeforeweldingit.Checkalsokneealignmentandfootrotation.


4Thetemperatureofthemirrorshouldbebetween185°and200°C.

4Holdthecylinderonthemirrorwelderfornomorethan5minutesuntilarollofmeltedPPisformed.

Weldaccordingtothemarksandapplyslightpressure.

welding the cylinders


length adjustment for a short stump

1.Thesocketisconnectedtotheconicalcupwithaconvexdiscinbetween.2.Thesecondconicalcupisconnectedtotheknee-jointwithanotherconvexdiscinbetween.3.Oncetheheighthasbeenadjusted,theconicalcupscanbeweldedtogether.

Staticordynamicalignmentcanbedoneeitherabovetheknee-jointorbelowthesocket.

length adjustment for a long stump: pay attention to minimum dimensions (see below)

A 22mmforconvex/concaveplatesB 40mmminimumdistancebetweenconnectionsurfaceandaxisoftheknee

A=22mm(minimum)

B=40mm

Dimensionstobedetermined:

A deviceforadjustingalignment

B distancebetweenupperpartoftheknee-jointandkneeaxis

A B

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med. laT. anT. posT. anT. posT.

anT. posT. anT. posT. med. laT.

Final prosthesis alignment

6ModularPPtechnologyallowsslidingandtiltingduringalignment.


neutral position Flexion extension

6Backwardoranteriorshiftingispossible.Shiftingcanalsooccurmediallyorlaterally.


Belt manufacture

Duringthefirstfittingwiththepatient,themeasurementforthebeltistakenfromthegreattrochanter,aroundthewaistandabovetheoppositeiliaccrestasfarasScarpa’striangle.

Thebeltcanbeeitheraleatheroracottonstrap,fixedwitha16mmbuckle.

Add15cmtothemeasurementtakenonthepatienttoallowforadjustmentduringfitting.


pOlypROpylene COsmeTIC manuFaCTuRe4

6Allcomponentshavetobeweldedtogether.

6Drilla5mmholeintheconcavecylinderandthepipe.

6Fixtheexpansionpin.


4RemovetheexcessPPforfinishingattheankleplate.

4Drawalinefollowingtheshapeofthefoot.

4Disassemblethefoot.

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Minus � mm


6Checkyourmarkandgrinditcarefuly.Checkoncemoreagainstthefoot.

4Stickadhesivetapeonthefootandmakeamarkwithapermanentmarkeronthetopoftheconvexankleandonthetape.

4Removethefootanddrawalineallaroundtheplate4mmfromtheedge.

Grindtheedgecarefully.


4Checkagainwiththefoot.

Onceagoodfithasbeenachieved,weldthetwoplatestogether:firstmakeagroovewiththeweldingironandthenweldwiththehot-airweldinggun.

Grindagaintoobtainasmoothfinish.

6Forheavyandactivepatients,astripof3mmPPcanbedrapedaroundtheconicalcupandalignmentsystemforextrastrength.Useanelasticbandagetotightenitwell.


4WhenthePPhascooleddown,grindtheedgesandweld.

4Protecttheknee-jointwithadhesivetape.

Grindthesocketwithsandpapertoroughenit.

FillthesocketwithPOPinordertofixthepipe.


4Shapethesocketwithplasteraccordingtothemeasurement.

4Smooththeplasterandcoveritwithastocking.

4Drape4mmPParoundthesocketinthesamewayasforthefirstsocket.


6OncethePPhascooleddown,removetheproximalpart.

Usetheoscillatingsawtoopentheseam.

Removetheplasterandcleanupthesocket.

Trimtheshellproximallyanddistallyinlinewiththesocketandtheknee-joint.

Replacetheshellonthesocket.

Weldtheseam.

Weldtheproximaledge.

Weldtheshelltotheknee-joint.


4Whentheweldingiscompleted,removetheexcessPP.

• Grindtheseambetweentheshellandtheknee-joint.

• Theseammustbegroundalmostflushwiththesocket.

• Grindtheproximaledgeofthesocket.

Thesethreepartsmustthenbepolished.

4Protectthepipeandtheknee-jointwithtape.

4ShapetheshankwithPOPanddrapeasheetof4mmPPoverit.


4Opentheshellandremovetheplaster.

4Inserttheprosthesisintothecosmeticshell.

Determineandgrindtheproximaltrimlineformaximumflexionoftheknee-joint.

4Weldtheseamandtheankleconnection.


4Grindandsmooththewelding.

6InsertanEVAwashercuttothesameshapeastheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.Thiswillalsopreventcreaking.

4Fixtheknee-jointbackontotheshank.

Fixthebelt.


eVa COsmeTIC manuFaCTuRe5

6RoughentheEVAbeforeapplyingittothePPsocket.GluelayersofEVAonthesocketandshapeit.Afinallayerof3mmEVAwillcovertheentireprosthesis,increasingthecircumferenceby1cm.

4Cutasheetof12mmEVAcorrespondingtothecircumferenceofthewoodenorplastermodelshank.SkivebothsidesoftheEVAandglue.


4PlacethesheetofEVAintheovenatabout120°untilitbecomessoft,thenbendittoobtainaconicalshape.Addtalcumpowderinsidetheconeandputitbackintheoven.

4PulltheEVAconeoverthemodelshankandtightenitwithanelasticbandage,oruseavacuumsystem.

4Cuttheposteriorproximaledgetoallowflexionoftheknee-joint.


4Tip:forfinishingpurposes,windatapearoundtheproximalaspectofthefoottopreventdamagetothefootcosmeticduringgrindingoftheEVA.

4Shapetheshankaccordingtothemeasurementstakenonthesoundleg.Thenglueitdistallyontopofthefoot.

InsertanEVAwashercuttotheshapeoftheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.

Fixtheshanktothesocket.Fixthebelt.


Reference list of materials


Designation Used forMaterialsPOP bandage 15 cm Cast-takingPOP powder Positive mouldContact glue Soft socketSoap (demoulding agent) Positive mouldTalcum powder ThermoformingVaseline Cast-takingNails Positive mouldColorant for plaster Positive mouldCotton/nylon stockinet dia. 8 or 10 cm Cast-takingCotton stockinet or sock Stump sockPP welding rod dia. 4 mm Welding componentsPolypropylene 5 mm Hard socketPolypropylene cosmeticPolypropylene 4 mm Cosmetic shellPP welding rod dia. 4 mm Welding componentsPOP powder Cosmetic shapeAdhesive tapeEVA cosmeticEVA 3 mm; 6 mm; 12 mmContact glue

pp, eVa and other consumables

MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.

Acknowledgements:

Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan

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

International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP

Physical Rehabilitation Programmeankle-Foot orthosis

Manufacturing guidelines

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prosthetics and orthotics manufacturing guidelines - 1 ... · the icrc’s “manufacturing...

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