prosthetics and orthotics manufacturing guidelines - 1 ... · pdf filealignment jig for...
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alignment Jig For lower-limb ProstheticsPhysical Rehabilitation Programme
Manufacturing guidelines
0868
/002
0
9/20
06
200
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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.Useofthealignmentjig 5
1.1Descriptionofthejig 51.2Possiblemovementsforpositioningthepositiveinspace 6
2.Installationofthejig 83.Choiceandlocationofcentringaccessories 94.Someexamplesofuse 11
4.1Trans-tibialsockets 114.2Trans-femoralsockets 13
Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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.
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�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
Objective of the manuals
TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.
Themainaimsoftheseinformativemanualsareasfollows:
• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.
Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Introduction
Everymanufacturingtechniquehasitsownspecificrequirements.ThetechniquebasedontheuseofpolypropylenewhichhasbeendevelopedbytheICRC’sphysicalrehabilitationprogrammeisalsosubjecttothisrule;itmustcombinequality,easeofuseandlowcost.
Thecomponentsfortrans-tibial(TT)andtrans-femoral(TF)prosthesesproducedbyCREquipementsSA(CRE)allowforcertainangularandtranslationadjustments,butthesepossibilitiesarelimited:• 20mmintranslationorsliding(2x10mmeachsidefromtheneutralpoint)• 20degreesintilting(2x10°oneachsideofthemedianaxis).
Itisadvisabletoretaintheseadjustmentpossibilitiesfordynamicalignment,andtotakeintoaccountthefactthatstaticalignmentfollowstheweight-bearingreferencelinestoachieveaneutralposition.
Inmostofthetechniquesusedforsocketmanufacturewithpolypropylene,theconnectioncomponent,calledthecup,isincludedinthesocketduringthethermoformingphase.Itisthelinkthatholdstheotherpartsoftheprosthesistogether.UsingthistechniquemeansthatthealignmentmustbeadjustedBEFOREthesocketthermoformingprocess.
Anothertechniqueallowstheproductionof“full-contact”sockets.Faultypositioningoftheconnectingcomponent(thesocketcup)duringweldingmakesalignmentdifficultorimpossibletoachieve.
Particularattentionmustthereforebepaidtowhethertheconnectingcuporsocketcupisplacedonthepositivebeforeorafterthethermoformingphase.
AspecialtoolhasbeendesignedandmanufacturedbytheICRCandCREtohelpprostheticandorthotic(P&O)technicianscompletethesealignmentphaseseasilyandwiththerequiredprecision.
Thistoolisthealignmentjig.
Objective of this document
Thepurposeofthisdocumentistodemonstratetherelevanceandusefulnessofthealignmentjigforobtaininghigh-qualityresults.
ThealignmentprinciplesappliedarebasedoninternationalP&Ostandards.
Remark
ThisdocumentisnotatechnicalmanualonthemanufactureofTTandTFprostheses.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
1.1 Description of the jig
Thealignmentjigisastainlesssteelframeabout2metreshighand0.8metreswide.Itissturdyandstable.
Use OF The alIgnmenT jIg 1
Positioning phase Fixation phase
6Thepurposeofthejigistofacilitatethepositioninginspaceofthepositiveplaster,andtoholdtheconnectioncup(orsocketcup)firmlyandpreciselyduringtheoperationtofixittotherectifiedpositivewithplaster(orbywelding).
Obviously,thisfixationphaseisindependentofthetypeofsocketused:theillustrationshowsTTprostheseswithandwithoutsoftsocket.
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4Inthecentreofthejigtherearetwocomponentswhichallowthepositioninginspaceandimmobilizationoftheplasterpositiveinrelationtothepositionoftheconnectioncup.
Atthetop:theballandsocketjoint.Thisallows:• suspensionandimmobilizationofthe
positive;• rotationaroundthepipeaxis;• forward,backwardandlateral
movements.
Below:thetray.Thisimmobilizestheconnectingpart(cuporsocketcup).
Theheightofthetrayisadjustable.Itisfixedonaverticalaxis,whichrepresentsthelegpartofthefutureprosthesis.
Tohelpthetechnicianvisualizethecomponentpartsofthefutureprosthesis,aprostheticfootisfixedtothelowerendofthisaxis.
Thealignmentprinciplesareindependentofheight.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
1.2 Possible movements for positioning the positive in space
4Longitudinalmovements.
4Lateralmovements.
4Ballandsocketrotation.
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�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
4Lockingoflongitudinalmovements.
4Gradientofthepipe.Thepipecandescribeaconeofabout30°atthesummit(about15°aroundtheverticalline).
4Theballandsocketallowscorrectpositioningofthepositiveevenwhenthepipeiswronglyplaced.
4Ballandsocketdetailsandblockingscrew.
Lockingofrotationandgradientofthepipecarrier.
Lockingoflateralmovements.
Tighteningofthepipe.
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Twoprecautionsmustbetakenbeforestartingtousethejig:
• Checkwithaspiritlevelthatthecentralbeamsupportingtheverticalaxis(whichinturnsupportsthetray)isperfectlyhorizontal,andmakeanynecessaryadjustmentsbymeansoftheadjustablefeet.
• Installplumblinesbeyondtherangeofmovementsofthepipecarrier.
Byestablishingfrontalandsagittalplanes,theseplumblinesallowexactapplicationoftheprinciplesofalignment.
InsTallaTIOn OF The jIg 2
4Frontalandsagittalplanesareestablishedwithplumblines(4x)beyondthemovementsofthepipecarrier.
4Checkwithaspiritlevelthatthecentralbeamisperfectlyhorizontal;adjustbymeansofadjustablefeet.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
(A)The tray
ChOICe anD lOCaTIOn OF CenTRIng aCCessORIes 3
4Thetrayhas3holesØM8.
Theholesituated2cmfromthecentreisusedforadultTFalignment
ThecentralholeisusedforadultandchildTT.
Theholesituated1cmfromthecentreisusedforchildTF.
WhenusedforadultTF,thepositivesagittalplanisperpendiculartothecentralbeam,andwhenusedforchildTF,themainlineofthisbeamisthesameasthepositivesagittalplane.
Positive front for adult size
Positive front for child-size BK
(B)Production by means of the “cup” (use of the centring cylinder)
Positive front
Positive rear
6AdultandchildTTalignment. 6AdultTFalignment.
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Positive front
Positive rear
6TFchild-sizealignment. 6Theconnectingcuponthetray.
(C)Production by means of the socket cup
Thesocketcupmakesitpossibletomanufacture“full-contactsockets”(withcontactontheentiresurfaceofthestump,includingtheextremity).
Theprinciplesarethesame;onlytheaccessoryisdifferent.
6TheaccessoryforcentringthesocketcupispositionedforTTinthecentralhole.
6ThesocketcupispositionedforadultTF.
5Centralbeammainline.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
sOme examPles OF Use 4
sockets without terminal contact
Theconnectioncupisassembledwiththepositivebeforethesocketthermoformingoperation(methodmostfrequentlyused).
�.� TT sockets
(A) alignment of a short TT positive (right)
6Posteriorview:Thepictureistakenofthepositivewithoutsoftsockettomaketheshapesandmarksofthepositivemoreclearlyvisible.Thepresenceorabsenceofasoftsockethasnoeffectonthealignmentprinciples.
View before joining View after joining
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6Lateralview:
View before joining View after joining
(B) alignment of a long TT positive (left)
lateral view before joining Posterior view before joining
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
�.� TF sockets
(A) Parameters to be observed between the CRe knee and the alignment jig
a=22mm(minimum)
b=40mm
Dimensionstobedetermined:
a deviceforadjustingalignment
b distancebetweenupperpartofthekneeandkneeaxis
a b
6Thereisa2cmgapbetweenthesocketfixationscrewandthekneeaxistotaketheflexumintoaccount.
6Thekneeaxisisonthesameverticallineasthepipe(thepartbelowtheknee).
Thesamepositioningfeaturesarefoundonthealignmentjig.
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(B) long stumps
6Itispossibletoadjustthedistancefromischiumtokneewhentheconnectioncupisbeingfixedbycalculatingheightainadvanceaccordingtothedetailsgivenabove.
Posterior view before joining side view after joining
a
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
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��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Al ignment J ig for Lower-Limb Prosthet ics
(C) short stumps
“Full-contact” sockets
Theconnectingelement(thesocketcupinthiscase)isassembledwiththesocketafterthethermoformingoperation.
Warning:Specialcaremustbetakenwhenthesocketcupisusedastheconnectingcomponentwiththe“contactsocket”,forthesafetyofthepatient.Indeed,inordertostrengthentheweldingbetweensocketandcupafterthermoforming,thesocketmustbecarefullyadjustedasshownintheillustrationabove.
Then,toensurethepatient’ssafety:• theweldingshouldbeperformedwithparticularcare;• thepatientshouldnotbeleftaloneduringthefittingandrehabilitationphases;• polypropylenemustbeusedforfinishingsoastoforman“exoskeleton”thatguaranteesthe
solidityoftheprosthesis.
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Thesocketcupiseasytouse:• Alignthesocketaccordingtothepossibilitiesofferedbythejig.• Installinthetraythecentringdevicedesignedforsocketcups.• Cutthesocketcupatthedesiredlengthandgiveittheappropriateshape.• Weldthesocketcuptothesocketlightlywithaweldingiron.• Removetheassemblythusobtained.• Endwithcarefulwelding.
(A) TT socket
short TT socket (side view) long TT socket (posterior view)
short TF socket (posterior view) long TF socket (side view)
(B) TF socket
ICRC Physical Rehabi l i tat ion Programme
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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
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Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
0868
/002
0
9/20
06
200