Hauv AVF koob tsim, qhov nruj ntawm kev tswj xyuas zoo cuam tshuam ncaj qha rau cov neeg mob kev nyab xeeb. Cov neeg tsim khoom tsim kom muaj tag nrho - txheej txheem kev tswj hwm kev ua tau zoo raws li ISO 13485 thiab siv rau 6 qhov chaw soj ntsuam tseem ceeb uas suav nrog kev txheeb xyuas cov khoom xa tuaj, hauv - txheej txheem soj ntsuam thiab ua tiav- cov khoom tso tawm, kom ua tiav xoom- tsis raug raws cai rau txhua txhua koob.

Rooj vag 1: Cov khoom siv raw khoom tuaj xyuas

Txhua lub stainless hlau batch undergoes spectroscopic tsom xam los xyuas cov tshuaj muaj pes tsawg leeg, xyuas kom meej chromium, nickel thiab molybdenum ntsiab lus raws li ASTM A269 specifications. Intergranular corrosion testing ib txoj kev tooj liab sulfate-sulfuric acid yog ua los tiv thaiv kev cuam tshuam corrosion los ntawm carbide nag lossis daus. Lub Cwj Pwm Technology tau txib cov neeg muag khoom los muab Qib 3.1 Cov Ntawv Pov Thawj Kev Ntsuas Cov Khoom Siv uas muaj cov ntaub ntawv pov thawj xws li yaj cov lej thiab cov kev kho cua sov, ntsuas cov khoom siv raw zoo ntawm qhov chaw.

Rooj vag 2: Hauv -Kev Tshawb Fawb Kev Ua Haujlwm

Thaum lub sij hawm sib tsoo, cov neeg ua haujlwm ua ib teev kev kuaj xyuas ntawm lub kaum sab xis (qhov kam rau ua ± 0.5 degree) thiab nto roughness (Ra Tsawg dua lossis sib npaug li 0.2 μm), tshuaj xyuas cov ntug kev ncaj ncees ntawm 50 × magnification ntawm optical profile projectors. Tom qab laser txiav, 3D confocal microscope ntsuas zawj dav (± 0.01 hli) thiab qhov tob (± 0.005 hli) kom lav qhov ntws channel ua raws li hydrodynamic tsim qauv. Kev Tswj Xyuas Txheej Txheem Txheej Txheem (SPC) cov kab kos tau muab tso rau ntawm cov kauj ruam tseem ceeb nrog cov txheej txheem kev muaj peev xwm xav tau (Cpk Ntau dua lossis sib npaug rau 1.33); kev tsim khoom nres tam sim ntawd rau kev kho kom raug raws li qhov tawm - ntawm - qhov txawv txav.

Rooj vag 3: Kev huv huv thiab kev tswj xyuas microbiological

Electropolished koob yog raug rau saum npoo qhov kev ntsuam xyuas los ntawm laser lub teeb scattering: tsis pub ntau tshaj 100 particles Ntau tshaj los yog sib npaug rau 0.5 μm yuav tsum muaj nyob rau hauv ib koob. Kev kuaj Endotoxin los ntawm Limulus Amebocyte Lysate (LAL) txoj kev txwv cov ntsiab lus endotoxin tsawg dua lossis sib npaug li 0.5 EU / mL. Ua ntej kev ntim khoom, kev kuaj tsis muaj menyuam yog ua los ntawm kev siv cov txheej txheem membrane filtration; batches raug tshem tawm rau kev tso tawm tsuas yog tom qab 14 hnub ntawm incubation uas tsis pom kev loj hlob microbial.

Rooj vag 4: Kev sim ua haujlwm ua haujlwm

Cov neeg tsim khoom tsim lub tshuab ua kom lub cev muaj zog ntxiv los ntsuas kev ua haujlwm hemodynamic siv cov ntshav bovine tshiab lossis simulated ntshav nrog 35% hematocrit, tawm tsam cov kev lees paub hauv qab no:

Cov ntshav ntws ntau dua lossis sib npaug li 300 mL / min rau 17G koob;

Trans- koob siab poob qis dua lossis sib npaug li 15 mmHg;

Tsis muaj thrombosis lossis txhaws tom qab plaub teev sib law liag ntawm kev ncig mus tas li.

Kev coj cwj pwm thev naus laus zis ntxiv rau hauv -vivo tsiaj sim ntawm cov qauv porcine femoral arteriovenous fistula, lub hom phiaj ntau dua lossis sib npaug rau 98% qhov kev ua tiav thiab Tsawg dua los yog sib npaug rau 1% vascular phab ntsa perforation tus nqi kom muaj nuj nqis vascular raug mob.

Rooj vag 5: Ntim thiab Daim Ntawv Pov Thawj

Kev ruaj ntseg ntim tau raug lees paub los ntawm kev tshuaj ntsuam dye penetration (zero dye ingress permised) thiab kuaj lub tshuab nqus tsev vacuum (xws li tus nqi qis dua lossis sib npaug li 0.01 mL / min). Daim ntawv lo durability raug lees paub tom qab rov ua dej cawv ntau dua thiab siab -kub kom tsis muaj menyuam, nrog rau tag nrho cov cim tseem ceeb. Txhua qhov cim cim cim cim (UDI) code raug tshuaj xyuas tawm tsam GS1 database los txheeb xyuas cov ntaub ntawv sib xws.

Rooj vag 6: Post-Kev soj ntsuam kev lag luam

Cov neeg tsim khoom tuav tswj xyuas qhov xwm txheej tsis zoo los sau cov lus tsis txaus siab hauv tsev kho mob suav nrog cov pob txha taub hau, ntshav tawm thiab txheej txheem- cuam tshuam txog kev kis kab mob. Kev tshawb nrhiav tau pib hauv 24 teev ntawm qhov xwm txheej tshaj tawm, nrog cov kev daws teeb meem raug muab tso rau hauv 48 teev. Kev tswj xyuas ib xyoos ib zaug hloov kho cov ntsiab lus zoo; Piv txwv li, qhov kev lees paub qhov raug quab yuam qhov pib rau lub ntsej muag ntse tau nruj los ntawm 0.8 N mus rau 0.6 N tom qab kho cov txheej txheem kho tshiab.

Xaus

AVF koob tswj kev ua tau zoo yog ib qho kev ua tiav tag nrho -lifecycle systematic program uas cov tuam txhab tau txhais ISO 13485 cov kev cai rau hauv cov txheej txheem kev ua haujlwm tau zoo. Tsuas yog kev tshuaj xyuas nruj thoob plaws rau lub rooj vag tshuaj xyuas ua rau muaj kev nyab xeeb, kev cia siab rau vascular nkag mus rau cov neeg mob hemodialysis.