Fatigue Life Validation Of 316 Stainless Steel Hypotube Rau Vascular Interventional Delivery Systems

Pain Points

316 stainless hlau hypotube ua raws li qhov tseem ceeb ua haujlwm rau kev cuam tshuam cov hlab ntsha me me, siv rau PTCA, peripheral vascular, neurological thiab plab aortic aneurysm kho. Peb lub peev xwm tsim tau npog txheej kab Ø0.20 mm-20 mm nrog tsawg kawg laser kerf dav 0.012 hli. Ntau yam laser-txiav qauv: nruam kauv txiav, cuam tshuam kauv txiav, radial txiav thiab cov qauv kev cai xa cov qhab nia hloov tau yooj yim, torque kis tau tus mob thiab kev ua haujlwm los tiv thaiv kink rau txoj hlab ntsha ntawm lub cev. Hypotube yog rov khoov thiab twisted thaum navigation hauv cov hlab ntsha tortuous, yog li kev qaug zog ncaj qha cuam tshuam rau kev nyab xeeb hauv chaw kho mob.

Cov ntsiab lus tseem ceeb hauv kev lag luam muaj nyob hauv kev qaug zog-lub neej validation ntawm 316 hypotube. Ua ntej, ntau lub tuam txhab tsuas yog ua qhov zoo li qub thiab kev tshuaj xyuas qhov muag, tsis muaj kev cuam tshuam ntawm kev sib tw cyclic bending-torsion qaug zog validation. Static mechanical indexes tsis tuaj yeem cuam tshuam qhov kev pabcuam tiag tiag ntawm hypotube nyob rau hauv rov ua haujlwm hauv tib neeg cov hlab ntsha. Txawm tias qhov chaw dhau qhov kev sim zoo li qub, lawv yuav raug kev qaug zog tawg tom qab qee qhov kev mus. Thib ob, kev cai hypotube ua rau ib tus neeg siv khoom 2D / 3D kos duab lossis cov qauv feem ntau rov siv qhov kev lees paub txaus los ntawm cov khoom lag luam. Qhov txawv ntawm phab ntsa-thickness, laser qauv thiab OD hloov kev ua haujlwm qaug zog ntawm 316 hypotube, tab sis kev siv tau zoo raug hla kom txuag sijhawm thiab nqi.

Thib peb, validation test condition deviates deb ntawm qhov chaw kho mob tiag tiag. Factories txais yuav qhov zoo tshaj plaws kev kuaj ntsuas tsis tuaj yeem simulate txoj kev khoov lub vojvoog thiab torsion load hauv kev ua haujlwm tiag tiag. Raws li ISO13485 kev tshuaj xyuas, cov ntaub ntawv pov thawj kev qaug zog tsis tiav yog cim tias tsis ua raws. Qhov kev pheej hmoo tsis ua rau qaug zog zais tsis tuaj yeem tshawb pom los ntawm kev tshuaj xyuas cov khoom tiav tas li. Thaum hypotube tawg hauv cov hlab ntsha thaum lub sij hawm kho mob, nws yuav ua rau muaj kev phom sij loj thiab cuam tshuam rau kev sau npe ntawm cov khoom siv kho mob. Ntau lub tuam txhab tsom mus rau laser txiav zoo tab sis tsis quav ntsej kev qaug zog-lub neej pov thawj ntawm qhov kawg hypotube los ua ke.

Txoj Cai

Kev qaug zog tsis ua haujlwm ntawm laser-txiav 316 stainless hlau hypotube feem ntau pib los ntawm txoj haujlwm kev ntxhov siab: laser-txiav qhov npoo, tshwj xeeb tshaj yog cov chaw nrog micro-crack, tshav kub-tshuaj lom los yog siab residual tensile stress. Nyob rau hauv rov qab cyclic dabtsi yog khoov thiab torsion load, micro-defects nthuav maj mam mus txog thaum kawg tawg.

Lub hauv paus ntsiab lus ntawm kev lees paub: simulate qhov chaw kho mob ntsig txog lub cev muaj zog, ntsuas seb 316 hypotube puas tuaj yeem muaj sia nyob txaus tus lej tsis muaj tawg lossis tawg. Cov yam ntxwv tseem ceeb muaj xws li cov khoom siv lis dej num, laser qhov-ntug zoo, seem-stress magnitude, hypotube phab ntsa-thickness, OD, laser-txiav qauv layout thiab amplitude ntawm dabtsi yog khoov-torsion load. Kev qaug zog validation yuav tsum tau txais kev pheej hmoo-raws li kev xav raws li ISO13485: hypotube rau neuro-intervention yuav tsum nruj dua kev qaug zog-lub neej yuav tsum tau muaj tsawg-ris hauv qab daim ntawv thov.

Kev ua kom qaug zog tsis yog ib qho qauv kuaj. Kev kuaj ntau tus qauv thiab ntau pawg yuav tsum tau soj ntsuam cov txheej txheem sib xws. Thaum cov khoom batch, phab ntsa-thickness, laser qauv ntawm 316 hypotube hloov, qaug zog kev ua tau zoo yuav hloov; re-validation yuav tsum tau ua raws li.

Kev faib cov cuab yeej & Tooling

Peb pawg ntawm cov cuab yeej txhawb kev qaug zog-lub neej validation rau 316 hypotube.

Ua ntej: Cov khoom siv ntsig txog kev tsim khoom. Loj-tsim laser txiav tshuab, hypotube fixture rau Ø0.20-20 hli series, kev ntxhov siab-relief thermal-kev kho cov khoom. Cov qauv kev lees paub yuav tsum yog los ntawm cov khoom tsim khoom tsim tawm es tsis txhob siv cov qauv siv tes ua.

Thib ob: Kev ntsuas qaug zog thiab ntsuas ntsuas. Multi-axis cyclic bending-torsion fatigue test bench for micro-tube, high-magnification optical microscope, metallographic microscope for fracture-surface analysis. Tag nrho cov cuab yeej xeem yuav tsum muaj daim ntawv pov thawj calibration siv tau raws li ISO13485.

Thib peb: Cov ntaub ntawv tswj xyuas kom zoo. Daim ntawv qhia kev qaug zog, kev soj ntsuam-kev soj ntsuam-qhov xwm txheej tshwj xeeb, kev lees paub rau qhov sib txawv-kev pheej hmoo-theem hypotube, kuaj-cov ntaub ntawv template, fracture-analysis report, validation xaus report, change-control document for standard or custom hypotube from customer drawing / sample. Cov ntaub ntawv lav tag nrho traceability ntawm qaug zog validation workflow.

Kev taw qhia tswv yim

Kauj Ruam 1: Kev soj ntsuam kev pheej hmoo thiab kev ntsuas ntsuas ntsuas. Qhia kom meej 316 hypotube tsis: OD, phab ntsa-thickness, laser-txiav qauv, phiaj xwm kev soj ntsuam daim ntawv thov scenario. Raws li kev npaj siv, txhais cov simulated dabtsi yog khoov vojvoog, torsion lub kaum sab xis, lub voj voog-number yuav tsum tau thiab tso cai tsis ua haujlwm. Teem kom muaj nuj nqis txaus txaus lees txais raws li ISO13485 kev faib tawm kev pheej hmoo.

Kauj Ruam 2: Npaj cov qauv kev lees paub. Xaiv cov qauv los ntawm cov khoom tsim tawm sib law liag ntawm 316 hypotube (nruam kauv / cuam tshuam kauv / radial / bespoke qauv). Rau kev cai hypotube los ntawm kev kos duab los yog qauv, xyuas kom meej cov qauv muaj kev cuam tshuam tiag tiag ntawm cov khoom tsim tawm. Sau tus lej batch thiab cov txheej txheem tseem ceeb ntawm txhua tus qauv.

Kauj Ruam 3: Ua qhov ntsuas kev qaug zog cyclic. Khiav bending-torsion cyclic test raws li predefined clinical-simulated load profile. Saib xyuas tus qauv xwm txheej thaum kuaj. Sau tus lej voj voog thaum pib tawg lossis tawg. Tom qab kev xeem tiav, ua qhov kev soj ntsuam metallurgical rau cov qauv ua tsis tiav los txheeb xyuas cov keeb kwm tsis ua haujlwm xws li slot-edge micro-defect.

Kauj Ruam 4: Ntsuam xyuas cov txiaj ntsig kev xeem thiab kev muaj peev xwm ua tiav. Txheeb xyuas cov ntaub ntawv qaug zog-lub neej ntawm ntau cov qauv los ntawm ntau pawg. Txiav txim seb qhov kev xeem ua tau raws li qhov kev lees paub ua ntej. Yog hais tias muaj kev tawg loj heev los yog tsis ua hauj lwm thaum ntxov, cov hauv paus ntsiab lus tshwm sim: cov khoom siv tsis zoo, laser txiav ntug tsis xws luag lossis cov teeb meem kev ntxhov siab. Ua kom zoo tshaj cov txheej txheem ntws raws li.

Kauj Ruam 5: Sau thiab pom zoo daim ntawv qhia kev qaug zog-validation. Tsim kom muaj kev tswj hwm niaj hnub tsim khoom, txheeb xyuas cov xwm txheej rov ua tau zoo: kev hloov kho ntawm cov qauv laser, kho phab ntsa tuab, hloov cov khoom siv raw khoom, kev tu cov cuab yeej loj.

Kauj Ruam 6: Khaws tag nrho cov ntaub ntawv xeem, cov qauv soj ntsuam cov ntaub ntawv thiab daim ntawv tshaj tawm kev lees paub, txaus siab ISO9001: 2015 thiab ISO13485 traceability yuav tsum tau rau kev tshuaj xyuas thiab sau npe khoom.

Xyaum xyaum

Hauv kev xyaum tsim khoom tiag tiag, ntau lub tuam txhab hypotube tsis nkag siab qhov kev ua haujlwm qaug zog: lawv tsuas yog kuaj ib lossis ob qho qauv hauv ib puag ncig hauv chav kuaj thiab kho nws ua tiav kev siv tau. Cov qauv me me tsis tuaj yeem cuam tshuam batch-to-batch variation ntawm pawg tsim tawm 316 hypotube. Lwm qhov teeb meem nquag yog siv qhov kev sim me me dhau deb ntawm qhov chaw kho mob vascular khoov tiag tiag; Qhov kev lees paub zoo li no tsis tuaj yeem ua rau muaj kev pheej hmoo qaug zog tiag tiag.

Rau me-OD nyias-phab ntsa 316 hypotube nyob ze Ø0.20 hli, cov nyhuv kev ntxhov siab yog nthuav dav, kev ua haujlwm qaug zog yog rhiab heev rau laser-slot ntug zoo thiab cov kev ntxhov siab seem. Txawm hais tias qhov kev sim tensile zoo li qub dhau los, kev qaug zog thaum ntxov tseem tuaj yeem tshwm sim. Rau kev cai hypotube hloov dua siab tshiab los ntawm cov neeg siv lub cev qauv, tsis tuaj yeem rov siv cov ntaub ntawv qaug zog ntawm cov khoom uas twb muaj lawm; yuav tsum muaj kev txheeb xyuas qhov qaug zog. Tom qab qhov kev lees paub tiav lawm, kev tsim khoom loj yuav tsis tuaj yeem hloov kho cov khoom siv hluav taws xob los yog cov khoom siv annealing yam tsis muaj kev hloov pauv-tswj kev pom zoo.

Cov ntsiab lus

Fatigue-life validation is indispensable security assurance for 316 stainless steel hypotube siv nyob rau hauv vascular interventional xa systems. Kev soj ntsuam zoo li qub tsis tuaj yeem hloov qhov kev ntsuas kev sib tw cyclic bending-torsion qaug zog. Laser-txiav hypotube xws li Ø0.20-20 hli OD nrog tsawg kerf 0.012 hli ua haujlwm nyob rau hauv rov qab deformation hauv tib neeg cov hlab ntsha; qaug zog tawg pib los ntawm qhov chaw-ntug micro-defect yuav ua rau muaj kev pheej hmoo loj heev.

Raws li ISO13485 kev pheej hmoo-raws li kev tswj kom zoo, kev qaug zog yuav tsum simulate qhov chaw kho mob-tseem ceeb load, txais yuav ntau-batch-multi-sample test tswv yim, thiab txuas cov txiaj ntsig nrog cov khoom siv ntws, laser txiav thiab cov txheej txheem kev ntxhov siab. Factories yuav tsum tau tshem tawm ntawm qhov kev xav tsis zoo uas "zoo dimension sib npaug ntawm kev pabcuam zoo". Kev ntseeg siab qaug zog txheeb xyuas qhov kev pabcuam kev nyab xeeb ntawm kauv-txiav, radial-cut thiab bespoke-pattern 316 hypotube rau PTCA, peripheral-vessel thiab neurological interventional devices.

Prospect & Cov lus qhia

Cov khoom siv me me-yuav ua rau muaj kev nkag mus rau vascular ntau dua, xav tau kev qaug zog ntau dua rau 316 hypotube. Cov neeg tsim khoom yuav tsum txhim kho kev qaug zog-validation system ua raws li ISO13485.

Tsim kev qaug zog-lub neej database rau 316 hypotube npog qhov sib txawv thiab cov qauv laser. Optimize test-bench muaj peev xwm rau micro-size hypotube ze rau Ø0.20 mm. Nyob rau theem tshiab-cov khoom tsim kho, ua kev soj ntsuam kev pheej hmoo qaug zog ua ke nrog kev tsim qauv laser. Daim ntawv kaw-loop zoo tswj npog raw-khoom siv, laser ua thiab qaug zog validation, txhawb downstream kev kho mob-duab sau npe thiab thoob ntiaj teb kev tswj xyuas, txhim khu cov khoom sib tw rau high-end interventional tivthaiv kev lag luam.