Lub tsev kho mob physiotherapy tau txais ib pawg tshiab ntawm 3D luam tawm lub dab teg rov ua haujlwm txhawb nqa. Cov khoom saib huv si thiab kev ncaj ncees tawm ntawm lub thawv. Tsis tas li ntawd nyob rau hauv ob lub lis piam, ntau tus neeg mob qhia txog kev khaus ntawm daim tawv nqaij raws nraim qhov twg lub brace tiv nrog lub hauv pliaj. Tus neeg ua txhaum? Cov hmoov seem seem thiab cov khoom lag luam dye uas tsis tau sim rau lub sijhawm ntev ntawm daim tawv nqaij.
Qhov xwm txheej no tshwm sim ntau dua li ntau pawg neeg yuav khoom paub. Hauv kev kho mob 3D luam ntawv, kev tshaj tawm - kev ua tiav tsis yog ib qho kev xaiv "tiav kov" - nws yog cov kauj ruam uas txiav txim siab seb lub cuab yeej puas muaj kev nyab xeeb rau hnav, raug cai muag, thiab kho kom ntseeg tau. Qhov no yog qhov tseeb tshwj xeeb tshaj yog rau cov kev pab kho mob uas tsim los nrog ob txoj kev siv hluav taws xob ntau tshaj plaws: Multi Jet Fusion (MJF) thiab Selective Laser Sintering (SLS).
Cov lus qhia siv tau no piav qhia meej txog qhov ua rau kev kho mob 3D luam ntawv tshaj tawm- cov kev xav tau sib txawv ntawm cov ntawv thov kev lag luam lossis cov neeg siv khoom. Nws tsom rau MJF thiab SLS rau kev txhawb nqa kev kho mob thiab orthotics, sib piv ob txheej txheem, thiab muab cov neeg yuav khoom ib daim ntawv teev meej meej rau cov neeg siv khoom xaiv. Txawm hais tias koj xav tau MJF 3D luam ntawv kev kho mob kev txhawb nqa,SLS 3D luam ntawv rau kev kho mob kho mob, lossis tab tom ntsuam xyuas lub chaw tsim khoom kho mob 3D luam ntawv, kev nkag siab qhov sib txawv no pab koj kom tsis txhob muaj nuj nqis kev cai qeeb thiab cov neeg mob tsis txaus siab.
Vim li cas ntawv kho mob -kev ua haujlwm tsis yog "kev tu thiab pleev xim" xwb
Hauv txhua hnub lossis kev lag luam 3D luam ntawv, tshaj tawm - kev ua haujlwm feem ntau txhais tau hais tias kev txhim kho cov tsos thiab ntaus cov kev zam yooj yim. Hauv daim ntawv thov kev kho mob - tshwj xeeb tshaj yog daim tawv nqaij- tiv tauj cov cuab yeej kho mob - peb txheej ntxiv ntawm lub luag haujlwm tuaj ua si:
Biocompatibility: Txhua qhov zas xim, txheej, sealant, lossis kho qhov chaw uas kov cov tawv nqaij yuav tsum muaj pov thawj muaj kev nyab xeeb (ISO 10993 kuaj).
Sterilization compatibility: Qhov saum npoo tiav yuav tsum muaj txoj sia nyob ntawm txoj kev xaiv kom tsis muaj menyuam tsis muaj degrading, leaching, lossis hloov qhov ntev.
Regulatory traceability: Txhua qhov ntsuas ntawm txhua kauj ruam ua tiav yuav tsum tau sau tseg, siv tau, thiab rov tsim dua rau kev tshuaj xyuas.
Surface-cov teeb meem cuam tshuam hauv cov khoom siv kho mob polymer uas siv rau hauv kev sib cuag nrog tus neeg mob ncaj qha tau txuas mus rau ib feem tseem ceeb ntawm cov xwm txheej tsis zoo. MJF thiab SLS ua tus thawj tswj hwm kev pab tsim kho kev tsim kho vim tias lawv xa cov teeb yuag, cov duab geometries sai sai - tsis tau lawv li -cov ntaub ntawv luam tawm tsim cov ntawv sib txawv heev- cov kev xav tau, uas seem ntawm tsab xov xwm no unpacks.
MJF 3D Printing Medical Rehabilitation Supportthiab SLS 3D Printing rau Kev Kho Mob Rehabilitation Aids ob leeg siv nylon (feem ntau PA12 los yog PA11), tab sis lawv cov hmoov fusion txheej txheem tsim qhov sib txawv pib qhov chaw uas tsav cov kev ua haujlwm sib txawv.
Rau qhov uas ua rau kev tshaj tawm kho mob - ua tiav qhov xav tau tshwj xeeb
Ntawm no yog 6 qhov uas tsis yog - cov kev xav tau sib tham tau uas cais kev kho mob - qib post- ua tiav los ntawm cov txheej txheem kev ua tiav. Txhua qhov suav nrog yuav ua li cas yog tias cov kauj ruam hla lossis ua tsis raug.
Biocompatibility ntawm kev kho deg Dyes, coatings, thiab sealants yuav tsum muaj ISO 10993-1 daim tawv nqaij- ntawv pov thawj tiv tauj. Tawm ntawm-cov-txheej khoom dyes feem ntau muaj cov hlau hnyav lossis cov khoom siv leachables uas ua tsis tau qhov kev ntsuam xyuas lom. Yuav ua li cas mus tsis ncaj ncees lawm yam tsis muaj nws: Cov tawv nqaij khaus khaus, tsis haum tshuaj, los yog kev cai tsis kam lees.
Kev tshem tawm cov hmoov seem Ob MJF thiab SLS ntxiab hmoov zoo hauv cov chaw so, lattices, thiab cov chaw textured. Rehabilitation braces zaum ncaj qha rau ntawm daim tawv nqaij rau cov sij hawm ntawm ib lub sij hawm, tig ib qho hmoov seem rau hauv qhov chaw khaus thiab kis kab mob. Yuav ua li cas mus tsis ncaj ncees lawm: hmoov migration, biofilm tsim, thiab tus neeg mob tsis xis nyob.
Sterilization method compatibility Ethylene oxide (EO) gas, gamma radiation, los yog (tsis tshua muaj) autoclave txhua qhov sib txawv nrog cov polymers thiab nto tiav. Tag nrho cov ncej- cov txheej txheem ua tiav yuav tsum raug lees paub rau txoj kev xaiv. Dab tsi mus tsis ncaj ncees lawm yam tsis muaj nws: Cov khoom degradation, qhov loj me hloov, lossis poob ntawm cov khoom siv tom qab ua kom tsis muaj menyuam.
Daim tawv nqaij -kev sib cuag saum npoo smoothness Lub cev- cov khoom siv hnav yuav tsum tau nruj dua Ra (qhov nruab nrab roughness) lub hom phiaj tshaj qhov chaw lag luam. Rough nto ntxiab cov kab mob thiab tsim cov ntsiab lus siab. Yuav ua li cas mus tsis ncaj ncees lawm tsis muaj nws: mob siab, kab mob colonization, thiab txo tus neeg mob ua raws.
Dimensional stability post-kev kho mob Nyias-walled orthotic shells yog rhiab heev rau cua sov los yog chemical post- ua. Warping txawm ob peb feem kaum ntawm ib millimeter tuaj yeem ua rau kev cai brace unwearable. Yuav ua li cas mus tsis ncaj ncees lawm yam tsis muaj nws: tsis zoo haum, siab hotspots, los yog ua tiav ntaus ntawv tsis ua hauj lwm nyob rau hauv kev siv.
Cov ntaub ntawv qhia txog kev taug qab tag nrho Txhua pawg yuav tsum suav nrog cov ntaub ntawv ntawm cov hmoov ntau, qhov tsis tiav, kev ua kom zoo, thiab cov ntaub ntawv ua kom tsis muaj menyuam. Yuav ua li cas mus tsis ncaj ncees lawm: ua tsis tau tejyam raws li txoj cai thiab tsis muaj peev xwm los txhawb kev tshaj tawm -kev soj ntsuam kev lag luam.
Vim li cas cov kev pab kho mob rov qab ua rau cov tawv nqaij nruj dua -cov cai tiv thaiv ntau dua li ntau cov khoom siv phais phais phais feem ntau luv luv - lub sij hawm los yog tag nrho sab hauv. Rehabilitation braces thiab orthotics nyob twj ywm nyob rau hauv ntev, rov qab sib cuag ntawm daim tawv nqaij - tej zaum 8-12 teev ib hnub twg rau lub hlis. Cov kws tswj xyuas yog li siv qhov kev tshuaj xyuas qhov siab rau qhov chaw chemistry thiab ntev -lub sij hawm biocompatibility.
MJF vs SLS rau kev pab kho mob rov qab los - yuav ua li cas tom qab - kev ua haujlwm txawv ntawm ob
MJF thiab SLS tsis hloov pauv tau thaum nws los txog rau kev kho mob tiav. Lawv raws li - cov yam ntxwv luam tawm ua haujlwm sib txawv kiag li.
MJF 3D Printing - Kev Kho Mob Rehab
Yam tshwm sim grey / tsaus; dyeing los yog coatings yog feem ntau rau cov neeg mob -zoo aesthetics.
Kev tshem tawm hmoov: hlaws blasting + compressed cua lossis ultrasonic tu.
Ib txwm smoother nto (feem ntau zoo dua rau kev sib cuag ntawm daim tawv nqaij).
PA12 lub hauv paus txheej txheem muaj biocompatibility zoo.
Dyeing yuav tsum tau biocompatible, tsis yog -leaching kho mob- qib dyes.
Sterilization: EO roj los yog gamma (autoclave feem ntau zam vim yog cua sov distortion).
SLS 3D Printing - Kev Kho Mob Rehab
Qhov chaw tawm dawb/tawm -dawb; hmoov "ncuav mog qab zib" tshem tawm yog ntau zog- hnyav.
Kev tshem tawm hmoov: ua kom tiav depowdering + ultrasonic lossis media blasting.
Rougher nto (Ra 8–15 µm raws li- luam tawm) - feem ntau xav tau kev smoothing ntxiv los yog sealing rau daim tawv nqaij.
PA11 lossis PA12; PA11 nyiam rau qhov zoo tshaj plaws flex qaug zog hauv dynamic orthotics.
Nto sealing lossis txheej feem ntau xav tau rau kev sib cuag ntawm daim tawv nqaij.
Sterilization: EO gas nyiam; validation tseem ceeb.
Kev tshawb fawb qhia tau hais tias MJF PA12 feem feem ntau ua tiav qhov ua tiav zoo dua li qhov sib npaug ntawm SLS qhov chaw tom qab kev tshaj tawm xov xwm, ua rau MJF nrov rau pom, tus neeg mob- ntsib kev txhawb nqa rov qab. Txawm li cas los xij, tus neeg sawv cev fusing hauv MJF tuaj yeem tso cov khoom seem uas xav tau cov txheej txheem tu kom raug. SLS qhov chaw, thaum rougher, tuaj yeem muab cov khoom sib txuas zoo dua rau cov padding lossis cov hlua khi - tab sis yuav tsum muaj cov kauj ruam ntxiv rau kev nyab xeeb ntawm daim tawv nqaij.
Dyeing 3D printed rehabilitation braces - dab tsi 'qib kho mob' txhais tau tias rau kev kho xim kho mob-qib dyeing tsis yog tshuaj pleev ib ce. Nws yuav tsum siv ISO 10993-raws li, tsis yog-migrating dyes uas muaj sia nyob kom tsis muaj menyuam yam tsis muaj xim los ntshav lossis tshuaj leaching. Tag nrho cov txheej txheem dyeing (da dej chemistry, qhov kub thiab txias, lub voj voog yaug) yuav tsum tau lees paub thiab sau tseg.
Cov kev cai tswj hwm - dab tsi FDA, EU MDR, thiab ISO 10993 txhais tau li cas rau koj cov cuab yeej kho mob
Kev ua raws cai tsis yog bureaucracy - nws yog pov thawj tias koj lub cuab yeej yuav tsis ua mob rau cov neeg mob.
FDA (Tebchaws USA): 21 CFR Part 820 Kev Tswj Xyuas Kev Ua Haujlwm Zoo ntxiv rau xyoo 2017 Kev Txiav Txim Siab rau Cov Khoom Siv Kho Mob Ntxiv Kev Qhia. Yuav tsum muaj tag nrho cov txheej txheem validation cov ntaub ntawv rau tu, tiav, thiab sterilization. Siv rau Chav Kawm I thiab II kho cov cuab yeej kho mob.
EU MDR 2017/745: Cov kev pab kho kho mob feem ntau yog Chav Kawm I lossis IIa. Cov ntaub ntawv thev naus laus zis yuav tsum suav nrog cov ntawv tshaj tawm tau lees paub- ua cov ntaub ntawv. CE marking xav tau qhov kawg-rau- xaus traceability los ntawm cov hmoov nyoos rau cov khoom ntim.
TS EN ISO 10993 Cov qauv thoob ntiaj teb rau kev soj ntsuam lom neeg. Txhua qhov kev kho mob saum npoo ntawm daim tawv nqaij yuav tsum raug kuaj los yog ua raws li cov ntaub ntawv sib npaug.
Cov qauv no tau teeb tsa qhov tsawg kawg nkaus kev cai lij choj hauv pem teb rau kev muag khoom hauv khw loj. Cov neeg muag khoom uas twb tau txais kev lees paub cov txheej txheem cov tsev qiv ntawv thiab cov ntaub ntawv tag nrho pab cov neeg yuav khoom tshem tawm kev lis kev cai thiab kev tshuaj xyuas sai dua.
Kev lag luam thoob ntiaj teb 3D luam ntawv prosthetics tau kwv yees kwv yees li $ 2.3 nphom los ntawm 2030, nrog rau kev cai - haum rau cov khoom siv kho kom rov zoo uas ua rau muaj kev loj hlob ntau. Kev tswj hwm kev ua raws cai tseem yog ib qho ntawm cov teeb meem saum toj kawg nkaus rau kev ntsuas kev tsim khoom.
Sunhingstones cov ntaub ntawv kawm: xa MJF rov kho lub dab teg txhawb nqa uas dhau ISO 10993 daim tawv nqaij- tiv tauj kuaj
Ib tug European rehabilitation khoom distributor xav tau ib tug ntau lawm batch ntawm kev cai MJF PA12 dab teg txhawb nqa tom qab- siv, npaj rau kev muag khoom thoob plaws EU lag luam raws li CE cim. Lawv cov khoom lag luam yav dhau los tau siv cov txheej txheem kev lag luam MJF tiav (cov hlaws tawg + tawm-- txee dub dye), tsis muaj ISO 10993 cov ntaub ntawv, thiab xa cov khoom nrog qhov nruab nrab ntawm qhov nruab nrab Ra ntawm 6.8 µm - saum toj kawg nkaus rau kev sib cuag ntawm daim tawv nqaij ntev. Txoj cai xa tawm raug tsis lees paub.
Sunhingstones, ua raws li lawv MJF 3D luam ntawv kho mob qhov chaw Hoobkas, coj mus. Peb tau siv cov kev kho mob uas tau lees paub- qib post- cov txheej txheem ua tiav: ultrasonic tu tom qab depowdering, ISO 10993- ua raws li biocompatible dye, vapor smoothing kom tiav Ra 2.1 µm, thiab cov ntaub ntawv ua tiav cov ntaub ntawv pov thawj. Qhov tshwm sim: ISO 10993 daim tawv nqaij-kev sib cuag tau dhau los ntawm kev xa tawm thawj zaug, CE cim tau tso cai nyob rau hauv yim lub lis piam, thiab xoom daim ntawv qhia txog kev khaus khaus los ntawm thawj 200 units tso rau hauv kev siv tshuaj kho mob. Qhov project no tau pom tias yog vim li cas thiaj xaiv ib qho kev pab cuam kho mob SLS 3D luam ntawv (lossis MJF sib npaug) nrog cov ntaub ntawv kho mob tseem ceeb tshaj qhov muaj peev xwm ntawm lub tshuab luam ntawv ib leeg.
Yuav ua li cas nug tus kws kho mob 3D luam ntawv ua ntej koj tso koj thawj qhov kev txiav txim
Siv daim ntawv teev 8-nug nug no thaum ntsuas cov chaw kho mob 3D luam ntawv lossis cov lag luam wholesale 3D luam ntawv kho mob kho qhov chaw muab khoom:
Koj puas muaj ISO 10993 cov ntaub ntawv tshuaj ntsuam xyuas roj ntsha rau koj tus qauv tshaj tawm - ua tiav?
Koj puas tuaj yeem ua kom pom qhov ua tau zoo Ra zoo tom qab koj cov kev kho mob - qib tiav?
Dab tsi dyes los yog coatings koj siv rau tus neeg mob -sib cuag - thiab lawv puas validated rau daim tawv nqaij?
Txoj kev ua kom tsis muaj menyuam twg uas koj tus qauv ua tiav tau raug lees paub rau?
Koj puas tuaj yeem muab tag nrho cov ntawv tshaj tawm - ua cov ntaub ntawv traceability rau kev xa ntawv?
Koj puas muaj kev paub txog kev npaj CE kos lossis FDA cov ntaub ntawv?
Koj ua li cas tswj qhov kev ruaj ntseg ntawm nyias -cov phab ntsa orthotic plhaub los tiv thaiv warping?
Kuv puas tuaj yeem tshuaj xyuas daim ntawv qhia zoo los ntawm daim ntawv xaj khoom kho mob yav dhau los?
Tus neeg muag khoom raug tsis yog teb cov lus nug no xwb - lawv twb muaj cov ntaub ntawv npaj ua ntej koj nug. Kev cai kho mob 3D luam ntawv kev pabcuam ISO cov neeg koom tes tau lees paub kho kev ua raws li cov txheej txheem kev khiav haujlwm, tsis yog qhov ntxiv -rau.
hauv kev kho mob 3D luam ntawv, tshaj tawm - kev ua haujlwm yog qhov ua rau lub cuab yeej muaj kev nyab xeeb rau hnav
Tshaj tawm - kev ua tiav hauv kev kho mob 3D luam ntawv tsis yog qhov kawg kov - nws yog kauj ruam uas txiav txim siab seb koj lub cuab yeej puas muaj kev nyab xeeb rau hnav, raug cai muag, thiab ntseeg siab los ntawm cov kws kho mob uas sau ntawv rau nws. Txawm hais tias koj ua haujlwm nrog MJF, SLS, lossis lwm yam thev naus laus zis, tus neeg muag khoom uas nkag siab tiag tiag qhov sib txawv ntawm kev lag luam thiab kev kho mob tiav yog ib qho tsim nyog tsim kom muaj kev sib raug zoo nrog ntev -.
FAQ
Cov ncej dab tsi -kev ua tiav MJF 3D luam ntawv xav tau rau cov cuab yeej kho mob kho mob?
Daim ntawv pov thawj tag nrho suav nrog kev tshem tawm cov hmoov zoo, biocompatible dyeing lossis txheej, smoothing nto kom ua tiav daim tawv nqaij -kev nyab xeeb Ra qhov tseem ceeb, sterilization compatibility validation, thiab ua tiav cov ntaub ntawv traceability. Txhua kauj ruam yuav tsum tau hais txog rau lub ntsiab lus tseem ceeb uas tau teev tseg ua ntej.
Puas yog SLS 3D luam ntawv muaj kev nyab xeeb rau daim tawv nqaij -hu rau kev pab kho mob?
Yog - thaum tsim nyog tshaj tawm - siv tau. SLS qhov chaw yuav tsum muaj kev tshem tawm cov hmoov ntau dua, kev sib khi ntawm qhov chaw lossis ua kom du, thiab ISO 10993- tau lees paub tiav kom ncav cuag qib kev nyab xeeb ntawm daim tawv nqaij tib yam li MJF.
Yuav ua li cas yog 3D luam ntawv rehabilitation braces thiab orthotics sterilized?
EO roj yog txoj kev siv ntau tshaj plaws thiab nyiam tshaj plaws rau cov khoom siv polymer vim nws ua haujlwm ntawm qhov kub thiab txias. Gamma hluav taws xob kuj tseem siv tau. Autoclave (steam) feem ntau yog zam vim cua sov thiab noo noo tuaj yeem cuam tshuam cov khoom nylon nyias. Txoj kev xaiv yuav tsum raug lees paub rau qhov tshwj xeeb tshaj tawm - ua tiav.
Dab tsi yog qhov txawv ntawm MJF thiab SLS ncej- ua rau cov khoom siv kho mob? MJF pib nrog denser, smoother nto uas lees txais txawm dyeing thiab yuav tsum tau nruj nruj smoothing. SLS ua rau lub ntsej muag rougher, ntxeem tau ntau dua uas feem ntau xav tau kev sib khi ntxiv rau kev sib cuag ntawm daim tawv nqaij. Kev tshem tawm hmoov thiab ua kom tsis muaj menyuam validation raws tu qauv kuj txawv. Lub workflows tsis interchangeable.
Puas yog 3D luam ntawv rov kho cov cuab yeej xav tau FDA lossis CE pom zoo?
Nws nyob ntawm kev faib tawm. Cov kev kho mob feem ntau yog Class I lossis IIa (EU) lossis Class I / II (FDA). Lawv xav tau cov ntaub ntawv kev txawj ntse, suav nrog cov ntawv tshaj tawm tau lees paub- cov ntaub ntawv ua tiav, tab sis tsis tas yuav muaj kev sim ua ntej ua ntej. CE cim thiab FDA 510 (k) txoj hauv kev ob qho tib si thov pov thawj tias cov khoom tiav tiav muaj kev nyab xeeb thiab ua tau raws li qhov xav tau.
Kuv yuav ua li cas thiaj nrhiav tau lub Hoobkas kho mob 3D luam ntawv uas ua haujlwm puv npo- ua raws li cov qauv kev kho mob?
Pib nrog ISO 10993 thiab ISO 13485 cov ntawv pov thawj, tom qab ntawd siv cov lus nug 8-cov lus nug saum toj no. Tshawb nrhiav cov neeg muag khoom uas tuaj yeem pom cov cuab yeej siv kho mob tiag tiag, tsis yog kev muaj peev xwm AM nkaus xwb. Thov cov ntaub ntawv coj mus kuaj thiab cov ntaub ntawv qhia txog kev ua tau zoo ntawm cov cuab yeej yav dhau los.
Cov ntaub ntawv
FDA: Technical Considerations for Additive Manufactured Medical Devices - Kev taw qhia rau Kev Lag Luam thiab FDA Cov Neeg Ua Haujlwm (2017) - fda.gov
EU MDR 2017/745: Txoj Cai ntawm Cov Khoom Siv Kho Mob - eur-lex.europa.eu
ISO 10993-1:2018 - Kev ntsuas tshuaj lom neeg ntawm cov cuab yeej kho mob - iso.org
ISO 13485:2016 - Cov Khoom Siv Kho Mob Kev Tswj Xyuas Zoo - iso.org
Grand View Research: 3D Printed Prosthetics Market Report (cov ntaub ntawv 2023) - grandviewresearch.com
Wohlers Report 2024 - wohlers.com
America Ua & ANSI AMSC AM Standardization Roadmap v2.0 - america-makes.us