prosthetics and orthotics manufacturing guidelines - 1 ... · pdf filetrans-tibial prosthesis...

trans-tibial ProsthesisPhysical Rehabilitation Programme

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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.Measurementsandsoftsocketmanufacture 63.Trans-tibialcupalignmentandsocketmanufacture 114.Buildinguptheprosthesisandbenchalignment 175.Polypropylenecosmeticmanufacture 26

5.1Cosmeticwithupperpartofsocketremoved 265.2CosmeticwithcompletePPsocket 34

6.EVAcosmeticmanufacture 41Referencelistofmaterials 46Standardcutsofpolypropylenesheetsforlower-limbprostheses 48

Manufac tur ing Guidel ines Trans-Tibial Prosthesis

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

Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Introduction

Theaimofthisdocumentistodescribeamethodformanufacturingtrans-tibial (TT) prosthesesusingtheICRC’spolypropylenetechnologyasappliedinICRCprojectsworldwide.

Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

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

For short and medium stump, adult

The alignment system and foot components are available in adult and child sizes.

Raw maTeRIals and COmpOnenTs1

4Description:

� Convexankle

� Twoconcavecylinders

� Convexdisc

� CylindricalTTcup

5 Flatsteelwasherandcountersunkheadbolt

6 SolidAnkleCushionHeel(SACH)foot

7 Hexagonalheadboltandlockwasher

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

For long stump

The alignment system and foot components are available only in adult size.

4PTB(patellar-tendon-bearing)socketsecuredwithacuffsuspension.Thesuspensioncanbeadjusted.

Incaseofmedio-lateralinstabilityofthekneeorforastronghyperextension,athighcorsetwithsidebarsissuitable.

Thiscanbemadewithorwithoutasoftliner.

Socket design

4Description:

� Concaveankle

� Convexdisc

� CylindricalTTcup

� Flatsteelwasher

5 SolidAnkleCushionHeel(SACH)foot

6 CountersunkheadM10boltandthelockwasher

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

measuRemenTs and sOFT sOCkeT manuFaCTuRe2

6PTB-SC(supra-condylar)

Shouldbemadewithasoftliner.

6PTB-SCSP(supra-condylar,supra-patellar)

Mustbemadewithasoftliner.

6Thepatientisassessed,aprescriptionismade,measurementsaretakenandmouldingandrectificationareperformedaccordingtobestP&Opractice.

7

soft liner manufacture


4Measuretheplastermould.Notethe:• smallestcircumference;• largestcircumerence;• length.

6Drawatrapezoidonasheetof6mmEVAaccordingtothemeasurementstakenbutadding3cmtothelengthontheshortsideofthetrapezoid.

CuttheEVAandskivethelateralandthedistalsides(about12mm).

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6Applyglueonbothskivedsidesandformacone.Keepthetrimmeddistalsideontheoutsideoftheconeandleaveitfreeofglue.


Applytalcumpowderinsidetheconeandontheplastermodel.

Thermoformingisdoneusingthevacuumpump,onaverticalsuctionhose.

HeattheEVAconeintheovenat120°C.

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4Allowthesoftlinertocooldownforfewminutes.

Removetheplasticbag.

Prepareapieceof6mmEVAtocoverthebottomedge.

Applygluetothetrimmededgeandthecovercap.

Heatthecapintheovenandmoulditonthesocket.

CutofftheextraEVAandgrindtillsmooth.

Addpaddingabovethemedialcondyleandotherareasifrequired.


6PulltheEVAconeovertheplastermould,keepingthegluedlineontheposteriorside,untilthetrimmeddistalsidecoincideswiththetipoftheplastermould.

Coverthemouldwithaplasticbag,closeitsecurelybelowthemouldwithanelasticstrapandswitchonthevacuumpump.

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4Coverthesoftsocketwithatubularcottonstockingandglue.


4Prepareasheetof3mmEVAtocoverthecotton.

SkiveonesideoftheEVA,applygluetotheentiresurfaceoftheEVAincludingtheskivedside,andplaceitintheovenat120°C.

Coverthesoftliner,startingfromtheposteriorside.RemovetheexcessEVAandgrindtheposteriorsideandthedistalparttillsmooth.

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4Lastly,coverthedistalpartwitha3mmor6mmEVA“cap”andgrindtillsmooth.


TRans-TIbIal Cup alIgnmenT and sOCkeT manuFaCTuRe3

4Grindtheedgeofthesocketcup.

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alignment of the trans-tibial cup

4Fixthenailatthebottomofthemould,wherethecupwillbeattached.

PlacetheTTmouldontheCRalignmentjig;alignaccordingtotheinstructionsontheuseofthejig(separatemanual).Performthealignmentinaccordancewiththemeasurementcard.Fixthecuptothesocketwithplaster.

4Fromthemiddleofthecondyle,theplumblineshouldpassabout1cminfrontofthecupaxis.


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manufacture of the socket (4 mm polypropylene)

measurements

4Whentheplasterhasset,smoothit.

4Add15cmtothemeasurementtakenatpatellalevel.


4Coverthesoftlinerwithanylonorcottonstocking.Removethenyloncoveringthecup.

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4FixaroundpieceofEVA(12+6mm)withanailinsidetheopeningofthecup.


4Add15cmtothemeasurementtakenatthedistalpart.

4Add15cmtothemeasuredlengthofthesocket.

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4Cutasheetof4mmPPcorrespondingtothesemeasurements.CleanthePPsheetandtheTeflonintheovenwiththinner.

Put the PP in the oven at 180°C .

4Switchonthevacuumpump;drapethePParoundthesocket.

Weldingseamposition:• forPPcosmetic:lateralormedial• forEVAcosmetic:posterior

CutofftheexcessPPwhileitis stillhot.

LeavethevacuumonuntilthePPcoolsdown.


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

6CutthePPaccordingtothetrimlines,removetheplasterwithoutdamagingthesocketlinerandPPsocket,andgrindtheweldingseamdownto3mm.

6Oncetheplasterisremoved,useascrewdrivertoremovethepieceofEVA.

6Grindthedistalpartandcheckthatthesurfaceisflat.

Formaximumstrength,keepaminimumPPthicknessof2to3mmunderthecup.

�7ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Tibial Prosthesis

buIldIng up The pROsThesIs and benCh alIgnmenT4

steps to follow:

•Ankle-footbuild-upandalignment;•Socketbuild-up;•Adjustmentoflengthandweldingofconcavecylinderbutt;•Finalbenchalignment.

6The foot, the convex ankle and the concave cylinder are attached together.

The window in the concave cylinder must be anterior.

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

ankle-foot alignment

Anextra4mmplatemustbeattachedtotheconvexankle.DrilltwoholesasshownontheillustrationbelowandfixthetwocomponentstogetherwithaPPweldingrod.This will prevent breakage of the foot bolt.

Components

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

preparation before fixation

Attachtheconcavecylinder(withtheopeninginfront)tothefootandtheconvexankle.

Theheelheightisadjustedaccordingtothepatient’sshoe;theconcavecylindermust be perpendicular to the ground.

Thefoothasaheelheightof10mm(maximumheelheight:15to20mm).

• The ankle alignment system allows antero-posterior movements (flexion, extension).• This alignment system is used to adjust the angulation of the prosthesis according

to heel height.• In any event, the concave cylinder must remain perpendicular to the ground.

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6Thefootisadjustedin5°to8°externalrotations.


6Checkthealignmentonceagainwiththepatient’sshoeonthefoot.

6Thesocketisattachedtotheconcavecylinderwiththeconvexdiscinbetween.

6Theopeningintheconcavecylinderremainsinfront.Thealignmentsystemisinneutralpositionforthefirstfitting.


4Adjustthelengthaccordingtothemeasurementstakenonthepatient.

Marktheconcavecylinderandsawofftheexcess.

Cuttheconcavecylinderatanangleof90°.

4Setthetemperatureofthemirrorwelderbetween185°and200°C.

6HoldtheconcavecylindersonthemirrorwelderuntilarollofmeltedPPforms.


6Carefullybringthecylinderstogetherandapplyslightpressure.

Concave cylinders correctly welded


Concave cylinders incorrectly welded

socket alignment

Thesocketisconnectedtoaconcavecylinderwithaconvexdiskinbetween.Theconnectionissecuredbyacountersunkheadboltandflatwasherinsidethesocket,withtheT-nutinsidetheconcavecylinder.

Shiftingcanoccurinalldirections:anterior,posterior,medial,lateralandcombinedmovements,witharangeof10mminalldirections

anterior shifting Initial position posterior shifting


6Thealignmentsystemalsoallowsflexion,extension,abduction,adductionandrotation.

6BenchalignmentisperformedaccordingtoP&Opracticeandadjustedduringfittingandduringthegaittrainingperiod.


6Beforethecosmeticismade,allthecomponentsmustbeweldedtogether.


pOlypROpylene COsmeTIC manuFaCTuRe5

TherearetwowaysofmanufacturingaPPcosmetic.

5.1 Cosmetic with upper part of socket removed

adjustment of ankle part

6Drawalinefollowingtheshapeofthefoot,thendisassemblethefoot.

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Minus � mm


4Checkyourmarkandgrinditcarefully.

Checkoncemoreagainstthefoot.

4Stickadhesivetapeonthefootanddrawalinewithapermanentmarkeronthetopoftheconvexankleandonthetape.

4Disassemblethefootanddrawalineallaroundtheplate4mmfromtheedge.

Grindtheedgecarefully.


4Checkagainwiththefoot.

Weldthetwoplatestogether,firstusingtheweldingirontomakeagrooveandthenweldingwiththehot-airweldinggun.

Grindagaincarefully.

manufacture of cosmetic shell

6Cutacrosstheprosthesisbelowthelevelofthehamstringtendonsandremovetheupperpart.

4SkivethePPedgecarefully.


4Addplastertoshapetheshank.

4Reducethecircumferenceoftheshankby3cmtoallowforthethicknessofthe4mmPPsheet.

Smooththeplaster.

Leavetheankleedgefree ofplasterforthefinalwelding.

4Fixthe4mmPPreinforcementplateatthepopliteallevelwith2nails.

4Drawanylonorcottonstockingovertheplaster.

Addtalcumpowder.

Heatthe4mmPPsheetintheovenat180°C.


4Glueornail5mmPPundertheankleplatetocompensateforretractionofthePPafteropening.

6DrapethePPundervacuum.

6CutofftheexcessPPattheweldingseam.Keepthevacuumonuntiltheplasticcoolsdown.


4Grindtheposteriorseamdownto2to3mm.Inthreeplaces,leaveawideroverlapofPPforholdingtheprosthesisduringwelding.

4Opentheseamcarefullywithanoscillatingsawtoavoidbreakage.

6RemovethePPshellfromtheprosthesisandremovetheplaster.Cleantheprosthesisthoroughlytoensurethatnopiecesofplasterremain.Puttheprosthesisbackintotheshell.


4HoldtheprosthesisinaparallelvicewithEVAorrubberprotectionbetweenthevicejawsandthecosmeticshell.Closethetwosidesoftheposteriorseamwithlockgripsand/orothersuitabletools.

Beforewelding,makeV-shapedindentationsalongtheseamwithaweldingiron.

4Thefinalweldingisdonewithahot-airweldinggunanda4mmPPweldingrod.

4Weldtheankletotheshell.Afterwelding,carefullyflattentheanklesurface.


4Polishwitharaspand/orasharppieceofglass.

4Attachthe4mmPPreinforcementtotheshellwithtubularrivets.

Thelaststepistofixthefootontheprosthesis.


5.2 Cosmetic with complete pp socket



�5

Minus � mm





4Disassemblethefootanddrawalineallaroundtheplate3mmfromtheedge.

Grindtheedgecarefully.


4Checkagainwiththefoot.

Onceagoodfithasbeenachieved,weldthetwoplatestogether:firstmakeagroovewiththeweldingironandthenweldwiththehot-airweldinggun.

Grindagaincarefully.

4Roughenthesurfaceofthesocket.

4Covertheconcavecylinderswithadhesivetape.


4Shapetheshankwithplaster.

4Drawanylonorcottonstockingovertheprosthesis.

4Glueornail5mmPPundertheankleplatetocompensateforshrinkageofthePPafterthermoforming.


6Drapeasheetof3mmPParoundthemouldundervacuum.

4Grindtheposteriorseamdownto2to3mm.Inthreeplaces,leaveawideroverlapofPPforholdingtheprosthesisduringwelding.

4Opentheseamcarefullywithanoscillatingsawtoavoidbreakage.

4RemovethePPshellfromtheprosthesisandremovetheplaster.Cleantheprosthesisthoroughlytoensurethatnopiecesofplasterremain.


4HoldtheprosthesisinaparallelvicewithEVAorrubberprotectionbetweenthevicejawsandthecosmeticshell.Closethetwosidesoftheposteriorseamwithlockgripsand/orothersuitabletools.

Beforewelding,makeV-shapedindentationsalongtheseamwithaweldingiron.

4Thefinalweldingisdonewithahot-airweldinggunanda4mmPPweldingrod.

4Weldtheankletotheshell.Afterwelding,carefullyflattentheanklesurface.


6Grindtheseamdownto2to3mm.Polishwitharasporapieceofglass.

6Weldtheproximalpartoftheprosthesis.

Thelaststepistofixthefootbackontheprosthesis.Checktheflatnessoftheankle.


eVa COsmeTIC manuFaCTuRe6







4Dismantlethefootanddrawalineallaroundtheplate,3mmfromtheedge.

4Grindtheedgecarefully.

4Roughenthesurfaceofthesocket.

For heavy patients, reinforce the concave cylinders with a 3 mm PP sheet.


4GluelayersofEVAontheprosthesis.

4Shapetomatchthesoundleg.

LeavetheankleplatefreeofEVAforthefinalcosmetic.

Bearinmindthefactthatanadditionallayerof3mmEVAwillcovertheentireprosthesis,andthatthiswillincreasethecircumferenceoftheprosthesisbyabout1cm.Atthisstage,checkyourcircumferencesbycomparingthemwiththemeasurementsnotedonthepatient’stechnicalcard,andreducethesizeby1cmallover.


4Cutasheetof3mmEVAaccordingtothecircumferencesmeasured,butlongerthanthemeasurements.

Skivethesidethatwillbegluedontopofthefoot.

SkiveonelongsideoftheEVAsheetandapplygluetothatpart.

TurntheEVAsheetover,andcoverthisreversesidewithglue.

4Applygluetotheentireprosthesis(exceptthefoot).

Heatthe3mmEVAsheetintheovenat120°Cforafewsecondsuntilitbecomesveryflexible.DonotoverheattheEVAoryoumayaccidentallymakeprintmarksonitduringmanipulation.

Takethe3mmEVAsheetoutoftheovenandglueitovertheprosthesis,startingbygluingtheskivededgealongtheposteriorsideoftheprosthesis.

4Thenstartgluingthe3mmEVAsheetontheprosthesisbyrevolvingtheprosthesisonit,applyingconstanttensionontheEVAtoavoidairbubblesandfolds.


4ThelaststepistoremovetheexcessEVAandtogrindtheseamandtheproximaltrimlineoftheprosthesissmoothly.

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ICRC Code Description Specification Unit of MeasureTrans-tibial module, childOCPOMODUTTC Countersunk head bolt

Flat washer, steelTrans-tibial cupConvex discConcave cylinder with M8 T-nutConvex ankle

M8 x 60 mmD40 x d10 x H2.5 mmD70 x H26 mm

dia. 22 mm

1 piece1 piece1 piece1 piece2 pieces1 piece

Reference list of materials

Components: Trans-tibial module, child

ICRC Code Description Specification Unit of MeasureTrans-tibial module, adultOCPOMODUTTA Countersunk head bolt

Flat washer, steelTrans-tibial cupConvex discConcave cylinder with T-nut M8Convex ankle

M10 x 60 mmD44 x d15 x H3 mmD70 x H26 mm

dia. 25 mm

1 piece1 piece1 piece1 piece2 pieces1 piece

Components: Trans-tibial module, adult

Weight per unit of measurement: 285 grams • Quantity per box: 25 sets • Box size: L40 x l30 x H44 cm

Weight per unit of measurement: 490 grams • Quantity per box: 25 sets • Box size: L40 x l30 x H44 cm


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ICRC Code Description Specification Unit of MeasureTrans-tibial module, long stump prosthesisOCPOMODUTTLA Flat washer, steel

Trans-tibial cupConvex discConcave ankle

D44 x d15 x H3 mmD70 x H26 mm

1 piece1 piece1 piece1 piece

Components: Trans-tibial module, long stump prosthesis

Weight per unit of measurement: 130 grams • Quantity per packet: 1 piece

ICRC Code Description SpecificationFeet for prosthesisOCPOFOOT... Foot 22 – 28 cm, left and right,

olive and terra coloursHeel, 10 mm

When ordering feet from 22 to 28 cm, change the number in the ICRC code and description.4With all the adult feet a M10 bolt and a M10 lock washer are included.4Weight per unit: (size 25) 605 grams • Quantity per box: 25 pcs. • Box L40 x l30 x H44 cmOCPOFOOT... Foot 14 -21 cm, left and right,

olive and terra coloursHeel, 10 mm

When ordering feet from 14 to 21 cm, change the number in the ICRC code and description.4With all child feet a M8 bolt and a M10 lock washer are included.4Weight per unit: (size 19) 340 grams. • Quantity per packet: 1 pc.

Components: Feet for prosthesis


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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 taking and soft socketCotton stockinet or sock Stump sockWelding rod PP dia. 4 mm Welding componentsPolypropylene 4 mm Hard socketEVA 3 mm Soft socketEVA 6 mm Soft socketPolypropylene cosmeticPolypropylene 3 or 4 mm Cosmetic shellWelding rod dia. 4 mm Welding cosmetic shellPlaster powder Cosmetic shapeAdhesive tapeTubular rivets (2) Posterior reinforcementEVA cosmeticEVA 3 mm; 6 mm; 12 mmContact glue

pp, eVa and other consumables

ICRC Physical Rehabi l i tat ion Programme

polypropylene sheet: 2000 mm x 1000 mm

standard cuts of polypropylene sheets for lower-limb prostheses

Trans-tibial socket4 mm

Trans-tibial cosmetic3 mm or 4 mm

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

0868

/002

0

9/20

06

200

prosthetics and orthotics manufacturing guidelines - 1 ... · pdf filetrans-tibial prosthesis...

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