Imiterere ya Polyvinyl Alcohol Embolic Microspheres idapfa kwangirika
Uduce twa Embolic Microspheres tugamije gukoreshwa mu kugabanya imiterere mibi y’imitsi itera imitsi (AVM) n’ibibyimba by’imitsi itera amaraso menshi, harimo n’udukoko two mu nda.
Izina risanzwe cyangwa risanzwe: Polyvinyl Alcohol Embolic Microspheres
Izina ry'ibyiciro: Igikoresho cyo Gutera Imitsi y'amaraso
Icyiciro: Icyiciro cya II
Igice: Indwara z'umutima n'imitsi
Microspheres za Embolic ni microspheres za hydrogel zishobora gukubanywa zifite ishusho isanzwe, ubuso bworoshye, n'ingano igenwa, zikorwa bitewe n'impinduka mu bya shimi ku bikoresho bya polyvinyl alcohol (PVA). Microspheres za Embolic zigizwe na macromer ikomoka kuri polyvinyl alcohol (PVA), kandi zikunda amazi, ntizishobora gukurwamo, kandi ziboneka mu bunini butandukanye. Umuti wo kubungabunga ni 0.9% ya sodium chloride. Amazi ya microsphere yuzuye polymer ni 91% ~ 94%. Microspheres zishobora kwihanganira gukuba kwa 30%.
Udupira twa Embolic Microspheres dutangwa tudahumanye kandi tugapfunyikwa mu ducupa tw'ikirahure dufunze.
Uduce twa Embolic Microspheres tugamije gukoreshwa mu gukuraho ubumuga bw'imitsi itera imitsi (AVM) n'ibibyimba by'imitsi itera amaraso menshi, harimo n'udukoko twa fibroids two mu mura. Mu kubuza amaraso kugera aho agenewe, ikibyimba cyangwa ubumuga burabura intungamubiri kandi bugagabanuka mu bunini.
Microspheres za Embolic zishobora gutangwa binyuze muri microcatheters zisanzwe ziri mu bwoko bwa 1.7-4 Fr. Mu gihe cyo gukoreshwa, Embolic Microspheres zivangwa n'ikintu kidakoresha ioni kugira ngo bikore umuti wo gusunika. Microspheres za Embolic zigenewe gukoreshwa rimwe kandi zitangwa zidafite ubwiza kandi zidakoresha pyrogen. Imiterere y'ibikoresho bya Embolic Microsphere isobanurwa mu mbonerahamwe ya 1 n'imbonerahamwe ya 2 hepfo.
Mu ngano zitandukanye za Embolic Microspheres, ingano zishobora gukoreshwa mu gukurura fibroid ya uterine ni 500-700μm, 700-900μm na 900-1200μm.
CE, ISO13485
FDA yo muri Amerika 510K
EN ISO 13485 : 2016/AC: 2016 Sisitemu yo gucunga ubuziranenge bw'ibikoresho by'ubuvuzi hakurikijwe ibisabwa n'amategeko
EN ISO 14971: Ibikoresho by'ubuvuzi bya 2012 - Gukoresha uburyo bwo gucunga ingaruka ku bikoresho by'ubuvuzi
ISO 11135:2014 Ibikoresho byo kwa muganga Gusukura okiside ya ethylene mu buryo bworoshye no kugenzura rusange
ISO 6009:2016 Inshinge zikoreshwa mu gutera imiti idafite ubusembwa zikoreshwa mu gupima ibara ry'umubare
ISO 7864:2016 Inshinge zikoreshwa mu gutera imiti idafite uburibwe
ISO 9626:2016 Imiyoboro y'urushinge rw'icyuma kidafunze ikoreshwa mu gukora ibikoresho by'ubuvuzi
SHANGHAI TEAMSTAND CORPORATION ni ikigo gikomeye gitanga imiti n'ibisubizo by'ubuvuzi.
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