Ama-Microspheres e-Embolic e-Elastic Design angaboli
Ama-Embolic Microspheres ahloselwe ukusetshenziselwa ukuvimbela ukukhubazeka kwemithambo yegazi (ama-AVM) kanye nezimila zemithambo yegazi, okuhlanganisa nama-fibroids esibeletho.
Igama Elivamile noma Elijwayelekile: Ama-Microspheres e-Polyvinyl Alcohol Embolic
Igama Lokuhlukaniswa: Idivayisi Yokumbolisa Imithambo Yemithambo
Ukuhlukaniswa: Isigaba II
Iphaneli: Inhliziyo Nemithambo Yegazi
Ama-Embolic Microspheres angama-microspheres e-hydrogel acindezelwayo anesimo esijwayelekile, ubuso obubushelelezi, kanye nosayizi olinganisiwe, akhiwa ngenxa yokuguqulwa kwamakhemikhali ezintweni ze-polyvinyl alcohol (PVA). Ama-Embolic Microspheres aqukethe i-macromer etholakala ku-polyvinyl alcohol (PVA), futhi ayathandeka emanzini, awakwazi ukusongelwa, futhi atholakala ngobukhulu obuhlukahlukene. Isixazululo sokugcina siyisisombululo se-sodium chloride esingu-0.9%. Okuqukethwe kwamanzi kwe-microsphere egcwele i-polymer kungu-91% ~ 94%. Ama-Microspheres angabekezelela ukucindezelwa okungu-30%.
Ama-Embolic Microspheres anikezwa ahlanzekile futhi apakishwe emabhodleleni engilazi avaliwe.
Ama-Embolic Microspheres ahloselwe ukusetshenziselwa ukuvimbela ukukhubazeka kwemithambo yegazi (ama-AVM) kanye nezimila ezithwala igazi eliningi, okuhlanganisa ne-uterine fibroids. Ngokuvimba ukuphakelwa kwegazi endaweni okuqondiwe kuyo, isimila noma ukukhubazeka kuyaphela izakhamzimba futhi kunciphe ngobukhulu.
Ama-Embolic Microspheres angalethwa ngama-microcatheters ajwayelekile kububanzi be-1.7-4 Fr. Ngesikhathi sokusetshenziswa, ama-Embolic Microspheres axutshwa ne-ejenti yokungafani engeyona i-ionic ukuze kwakheke isixazululo sokumiswa. Ama-Embolic Microspheres enzelwe ukusetshenziswa kanye futhi anikezwa ahlanzekile futhi angenawo ama-pyrogenic. Ukucushwa kwedivayisi ye-Embolic Microsphere kuchazwe kuThebula 1 kanye neThebula 2 ngezansi.
Phakathi kwezinhlobo ezahlukene zobukhulu be-Embolic Microspheres, izinhlobo zobukhulu ezingasetshenziswa ekufakweni kwe-uterine fibroid yi-500-700μm, 700-900μm kanye ne-900-1200μm.
I-CE, ISO13485
I-USA FDA 510K
I-EN ISO 13485: 2016/AC: 2016 Uhlelo lokuphatha ikhwalithi yemishini yezokwelapha lwezidingo zomthetho
I-EN ISO 14971: Amadivayisi ezokwelapha ka-2012 - Ukusetshenziswa kokuphathwa kwezingozi kumadivayisi ezokwelapha
I-ISO 11135:2014 Idivayisi yezokwelapha Ukuhlanza i-ethylene oxide Ukuqinisekiswa nokulawulwa okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane Khomba ikhodi yombala
I-ISO 7864:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane
ISO 9626:2016 Amashubhu enaliti yensimbi engagqwali yokwenziwa kwamadivayisi ezokwelapha
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