Tsarin Nauyin Nauyin Polyvinyl Alcohol Embolic Microspheres
An yi nufin amfani da ƙananan ƙwayoyin halittar Embolic don embolization na jijiyoyin jini (AVMs) da ciwon daji na jijiyoyin jini, gami da fibroids na mahaifa.
Suna na gama gari ko na yau da kullun: Polyvinyl Alcohol Embolic Microspheres
Sunan Rarrabawa: Na'urar Gyaran Jijiyoyin Jini
Rarrabawa: Aji na II
Faifan Bidiyo: Zuciya da jijiyoyin jini
Microspheres na Embolic microspheres ne masu matsawa waɗanda ke da siffa ta yau da kullun, saman da yake santsi, da girman da aka daidaita, waɗanda aka samar sakamakon gyaran sinadarai akan kayan polyvinyl alcohol (PVA). Microspheres na Embolic sun ƙunshi macromer da aka samo daga polyvinyl alcohol (PVA), kuma suna da hydrophilic, ba za a iya sake shafawa ba, kuma suna samuwa a cikin girma dabam-dabam. Maganin kiyayewa shine maganin sodium chloride 0.9%. Yawan ruwan microsphere da aka polymerized cikakke shine 91% ~ 94%. Microspheres na iya jure matsin lamba na 30%.
Ana samar da ƙananan ƙwayoyin halitta masu kama da Embolic kuma an naɗe su a cikin kwalaben gilashi da aka rufe.
An yi nufin amfani da ƙananan ƙwayoyin halittar jini (Embolic Microspheres) don embolization na jijiyoyin jini (AVMs) da ciwon daji masu yawan jini, gami da fibroids na mahaifa. Ta hanyar toshe hanyoyin jini zuwa yankin da ake nufi, ciwon ko matsalar na iya zama rashin abinci mai gina jiki kuma girmansa yana raguwa.
Ana iya isar da ƙananan ƙwayoyin cuta ta hanyar ƙwayoyin cuta na yau da kullun a cikin kewayon 1.7-4 Fr. A lokacin amfani, ana haɗa ƙananan ƙwayoyin cuta na Embolic da wani wakili mai bambanci na nonionic don samar da maganin dakatarwa. Ƙananan ƙwayoyin cuta na Embolic an yi su ne don amfani ɗaya kuma ana samar da su ba tare da sinadarai ba kuma ba sa haifar da pyrogenic. An bayyana tsarin na'urar Embolic Microsphere a cikin Jadawali na 1 da Jadawali na 2 a ƙasa.
Daga cikin nau'ikan girman Embolic Microspheres daban-daban, girman da za a iya amfani da shi don embolization na fibroid na mahaifa sune 500-700μm, 700-900μm da 900-1200μm.
CE, ISO13485
Hukumar FDA ta Amurka 510K
EN ISO 13485: 2016/AC: 2016 Tsarin kula da ingancin kayan aikin likita don buƙatun ƙa'idoji
TS EN ISO 14971: 2012 Na'urorin likitanci - Aiwatar da hanyoyin kula da haɗari ga na'urorin likitanci
ISO 11135: 2014 Tsaftace na'urorin likitanci na ethylene oxide Tabbatarwa da sarrafawa gabaɗaya
ISO 6009: 2016 Allurar allurar da ba a iya zubarwa ba ta bayyana lambar launi
ISO 7864: 2016 Alluran allurar da ba a iya zubarwa ba
TS EN ISO 9626: 2016 Bututun allurar bakin ƙarfe don kera kayan aikin likita
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