Nickel-Titanium Alloys Txhawb Cov Txheej Txheem Neurointerventional - Xov Xwm

Nyob rau hauv xyoo tas los no,npib tsib xee-titanium zoo li nco alloys, raws li cov khoom tseem ceeb thiab cov khoom tseem ceeb rau siab -kawg cov cuab yeej kho mob, tau pom lawv cov ntawv thov txuas ntxiv mus ntxiv hauv cov txheej txheem neurointerventional thiab cov hlab plawv. COMETIU tus kheej- nthuav dav cov tshuaj intracranial-eluting stent system, tsim los ntawm Sino Medical lub koom haum Sino Shenchang, tau ua tiav EU MDR CE daim ntawv pov thawj, dhau los ua thawj intracranial stent hauv nws qeb thoob ntiaj teb kom tau txais daim ntawv pov thawj no. Qhov kev tawg no yuav tsis tuaj yeem ua tsis tau yog tias tsis muaj kev txhawb nqa zoo los ntawm cov khoom siv nickel-titanium alloy.

Intracranial vascular phais imposes ze li ntawm cov kev cai ntawm implanted cov khoom: muab lub tortuous thiab ilv xwm ntawm cov hlab ntsha, stents yuav tsum sib txuas superelasticity, qaug zog tsis kam, thiab radial txhawb thaum tseem muab biocompatibility zoo heev - ua nickel- titanium alloy cov khoom zoo tagnrho rau daim ntawv thov no. Lub COMETIU tau tso cai tshiab stent nta lub matrix precision-machined los ntawm npib tsib xee-titanium alloy raj. Leveraging lub cim xeeb zoo thiab superelastic zog ntawm npib tsib xee-titanium alloy, lub stent tuaj yeem xa mus rau hauv lub xeev compressed los ntawm nqaim, tortuous intracranial hlab ntsha los ntawm kev xa khoom. Thaum mus txog qhov chaw mob, nws cia li nthuav dav kom ua raws li cov phab ntsa ntawm cov hlab ntsha, muab kev txhawb nqa ruaj khov rau cov hlab ntsha stenotic.

Ntxiv rau cov npib tsib xee-titanium alloy substrate, cov khoom lag luam nta ob txheej txheej txheej tsim: txheej txheej PBuMA thiab txheej txheej sab saud ntawm biodegradable PLGA coated nrog sirolimus. Kev sib koom ua ke ntawm cov tswv cuab raug kaw- voj asymmetric mesh qauv nrog kev tswj hwm- tso tawm cov tshuaj xa khoom thev naus laus zis, lub stent ua kom muaj kev sib raug zoo nrog cov hlab ntsha thaum tso cov tshuaj los inhibit restenosis, ncaj qha daws cov teeb meem ntawm intracranial atherosclerotic stenosis. Cov khoom no yog npaj rau cov neeg mob uas muaj vascular stenosis tshaj 70% uas tsis tau teb zoo rau kev kho tshuaj. Nws yog tsim rau siv cov hlab diameters ntawm 2.0-4.5 hli thiab tuaj yeem kho qhov txhab mus txog 34 hli ntev. Cov khoom lag luam tau ua kom tsis muaj hluav taws xob hluav taws xob thiab muaj lub neej txee ntawm ob xyoos.

EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR) sawv cev rau qhov siab tshaj plaws thoob ntiaj teb kev nkag mus rau qib siab - cov khoom siv kho mob uas muaj feem cuam tshuam. Piv nrog rau yav dhau los Cov Lus Qhia Txog Cov Khoom Siv Kho Mob (MDD), MDR tau tsa cov qauv thoob plaws hauv pawg thawj coj- suav nrog cov ntaub ntawv pov thawj kho mob, cov ntaub ntawv kev tshaj lij, kev tswj hwm kev tsim khoom, thiab tom qab- kev soj ntsuam kev ua lag luam- ua rau muaj kev nyuaj ntawm cov txheej txheem tshuaj xyuas. Ua tiav qhov kev tshuaj xyuas MDR nruj tsis tsuas yog ua kom pom tias Sino Medical cov khoom tsim thiab kev tsim khoom tswj tau zoo raws li cov qauv thoob ntiaj teb tab sis kuj qhia ncaj qha tias Tuam Tshoj tus npib tsib xee-titanium alloy ua, precision engraving, thiab txheej thev naus laus zis tau koom nrog lub ntiaj teb sab saum toj qib.

Tau ntev, lub teb chaws siab -kawg neurointerventional kev ua lag luam tau tswj hwm los ntawm cov khoom lag luam txawv teb chaws, thiab cov khoom siv hauv tsev tau ntsib teeb meem loj hauv kev tawg mus rau hauv kev lag luam tseem ceeb hauv Tebchaws Europe thiab Tebchaws Meskas. Intracranial stents raug cais raws li Chav Kawm III siab- cov khoom pheej hmoo implantable, thiab tag nrho cov saw hlau ntau lawm - los ntawm kev npaj raj, laser txiav, deburring, thiab kev hloov kho saum npoo rau cov tshuaj -eluting txheej- yog yam ntxwv los ntawm cov txheej txheem siab heev. Lub purity, uniformity, thiab qaug zog tsis kam ntawm nickel -titanium alloy tubing ncaj qha txiav txim siab txog kev nyab xeeb ntawm stents thaum lub sij hawm ntev - siv nyob rau hauv tib neeg cov hlab ntsha, yog li tsis muaj kev nthuav dav hauv cov txheej txheem tsim khoom tuaj yeem raug saib xyuas. Tau kawg, tau txais daim ntawv pov thawj EU MDR tsuas yog thawj kauj ruam rau cov khoom siv kho mob hauv tsev nkag mus rau thoob ntiaj teb kev lag luam. Daim ntawv pov thawj no tsuas yog siv rau European Union thiab European Economic Area; Daim ntawv thov kev sau npe tseem yuav tsum tau muab cais rau lwm lub tebchaws thiab cheeb tsam. Kev ua tiav kev lag luam tawm txawv teb chaws tseem xav kom ua tiav ntau txoj haujlwm, suav nrog kev sau npe hauv ntau lub tebchaws, kev txhim kho channel, nkag mus rau hauv tsev kho mob, thiab kev sib tham txog kev pov hwm kev noj qab haus huv. Ua ke nrog qhov tsis paub tseeb xws li kev hloov pauv txoj cai, kev sib sau ntawm cov ntaub ntawv kho mob, thiab kev hloov pauv ntawm tus nqi pauv, nws yuav nyuaj rau ua tiav cov txiaj ntsig loj - hauv lub sijhawm luv. Daim ntawv pov thawj technical tsis sib npaug rau kev lag luam ua tiav; kev lag luam txawv teb chaws rau cov khoom siv neurointerventional muaj lub sijhawm ntev incubation, thiab nws yuav siv sij hawm kom paub cov txiaj ntsig.

Saib ntawm kev lag luam tag nrho, cov khoom siv hlau tshwj xeeb ua haujlwm zoo-xws li npib tsib xee-titanium alloys- tau dhau los ua tus tsav tsheb tseem ceeb rau cov khoom siv kho mob hauv tsev siab - kawg rau kev ua lag luam thoob ntiaj teb. Los ntawm coronary stents mus rau intracranial interventional cov cuab yeej, cov tuam txhab lag luam hauv tsev tau maj mam txav deb ntawm tsuas yog xa tawm tsawg- cov khoom siv kawg thiab tab tom nce mus rau kev xa tawm siab - kawg cov khoom siv cog qoob loo raws li kev tsim kho tshiab. Cov ntaub ntawv tsim lub hauv paus ntawm cov khoom siv kho mob. Tsuas yog los ntawm kev txhim kho txuas ntxiv hauv kev ua haujlwm ntawm npib tsib xee-titanium alloys thiab cov txheej txheem machining precision tuaj yeem tsim kho cov khoom siv kho mob hauv tsev kom ruaj ntseg nkag mus rau hauv kev lag luam thoob ntiaj teb. Thaum cov khoom siv neurointerventional hauv tsev tau ua tiav qhov kev ua tiav loj hauv kev lees paub, tseem muaj txoj hauv kev ntev ua ntej hla ntau yam - suav nrog cov khoom siv, txheej txheem tsim khoom, kev siv tshuaj kho mob, thiab kev lag luam- txhawm rau ntes cov lag luam txawv teb chaws ntawm qhov loj. Raws li Tuam Tshoj cov khoom siv tshwj xeeb alloy kev lag luam tseem tab tom loj hlob, ntau yam tshiab hauv tsev kho mob cov cuab yeej tsim los ntawm cov khoom siv hlau zoo tshaj plaws yuav ua rau lub ntiaj teb theem yav tom ntej.

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