IiMicrospheres ze-Elastic zePolyvinyl Alcohol Embolic ezingonakalisiyo
Ii-Embolic Microspheres zenzelwe ukusetyenziselwa ukuthintela ukungasebenzi kakuhle kwemithambo yegazi (ii-AVM) kunye nee-hypervascular tumors, kuquka ne-uterine fibroids.
Igama Eliqhelekileyo okanye Eliqhelekileyo: IiPolyvinyl Alcohol Embolic Microspheres
Igama loHlelo: Isixhobo sokuQinisekisa iMithambo yeVascular
Udidi: Iklasi yesiBini
Iphaneli: Intliziyo kunye neMithambo
Ii-Embolic Microspheres zii-hydrogel microspheres ezinokucinezelwa ezinemilo eqhelekileyo, umphezulu ogudileyo, kunye nobukhulu obulinganisiweyo, ezenziwe ngenxa yokuguqulwa kweekhemikhali kwizinto ze-polyvinyl alcohol (PVA). Ii-Embolic Microspheres zenziwe yi-macromer ethathwe kwi-polyvinyl alcohol (PVA), kwaye ziyakwazi ukufudumala emanzini, azikwazi ukuxutywa, kwaye zifumaneka ngobukhulu obahlukeneyo. Isisombululo sokugcina sisisombululo se-sodium chloride esingu-0.9%. Umxholo wamanzi we-microsphere e-polymerized ngokupheleleyo yi-91% ~ 94%. Ii-Microspheres zinokunyamezela ukucinezelwa kwe-30%.
Ii-Embolic Microspheres zifumaneka zingenazintsholongwane kwaye zipakishwe kwiibhotile zeglasi ezivaliweyo.
Ii-Embolic Microspheres zenzelwe ukusetyenziselwa ukuqinisa imithambo yegazi emithanjeni (ii-AVM) kunye nee-hypervascular tumors, kuquka nee-uterine fibroids. Ngokuthintela ukuhanjiswa kwegazi kwindawo ekujoliswe kuyo, ithumba okanye i-malformation ayifumani izondlo kwaye iyancipha ngobukhulu.
Ii-Embolic Microspheres zinokuziswa ngee-microcatheters eziqhelekileyo kuluhlu lwe-1.7-4 Fr. Ngexesha lokusetyenziswa, ii-Embolic Microspheres zixutywa ne-arhente yokungafani engekhoyo ionic ukwenza isisombululo sokuxhoma. Ii-Embolic Microspheres zenzelwe ukusetyenziswa kube kanye kwaye zinikezelwa zingenazintsholongwane kwaye azina-pyrogenic. Ulwakhiwo lwesixhobo se-Embolic Microsphere luchazwe kwiTheyibhile 1 kunye neTheyibhile 2 ngezantsi.
Phakathi kobukhulu obahlukeneyo be-Embolic Microspheres, ubukhulu obunokusetyenziswa kwi-uterine fibroid embolization yi-500-700μm, 700-900μm kunye ne-900-1200μm.
I-CE, ISO13485
I-USA FDA 510K
EN ISO 13485 : 2016/AC: 2016 Inkqubo yolawulo lomgangatho wezixhobo zonyango ngokweemfuno zomthetho
I-EN ISO 14971: Izixhobo zonyango zika-2012 - Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135:2014 Izixhobo zonyango Ukucoca i-ethylene oxide Ukuqinisekiswa kunye nolawulo ngokubanzi
I-ISO 6009:2016 Iinaliti zokujova ezingafunekiyo nezilahlwayo Chonga ikhowudi yombala
I-ISO 7864:2016 Iinaliti zokujova ezingasetyenziswanga nezingenazintsholongwane
I-ISO 9626:2016 Iityhubhu zeenaliti zentsimbi engenasici zokwenza izixhobo zonyango
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