I-Vascular Embolization Device Polyvinyl Alcohol Embolic Microspheres
Izinkomba Zokusetshenziswa (Chaza)
I-Embolic Microsphereskuhloswe ukuthi kusetshenziselwe ukuhlanganisa i-arteriovenous malformations (AVMs) kanye nezimila ze-hypervascular, kuhlanganise ne-uterine fibroids.
Igama Elivamile noma Elivamile:I-Polyvinyl Alcohol Embolic MicrospheresUkwahlukanisa
Igama:Idivayisi Yokuqinisa Imithambo yegazi
Ukuhlukaniswa: Ikilasi II
Iphaneli:Inhliziyo nemithambo yegazi
Incazelo Yedivayisi
I-Embolic Microspheresama-microspheres e-hydrogel acindezelayo anomumo ojwayelekile, indawo ebushelelezi, nosayizi olinganisiwe, akhiwa ngenxa yokuguqulwa kwamakhemikhali ezintweni ze-polyvinyl alcohol (PVA). I-Embolic Microspheres iqukethe i-macromer ethathwe ku-polyvinyl alcohol (PVA), futhi ayi-hydrophilic, ayi-resorbable, futhi atholakala ngebanga losayizi. Isixazululo sokulondoloza yisisombululo se-sodium chloride esingu-0.9%. Okuqukethwe kwamanzi e-microsphere eyenziwe nge-polymerized ngokugcwele kungama-91% ~ 94%. Ama-Microsphere angakwazi ukubekezelela ukucindezelwa okungama-30%.
I-Embolic Microspheres inikezwa inyumba futhi ifakwe ezitsheni zengilazi ezivaliwe.
I-Embolic Microspheres ihloselwe ukusetshenziselwa ukuhlanganisa i-arteriovenous malformations (AVMs) kanye nezimila ze-hypervascular, kuhlanganise ne-uterine fibroids. Ngokuvimbela ukunikezwa kwegazi endaweni okuhlosiwe, isimila noma ukukhubazeka kulambile ngenxa yezakhi zomzimba futhi ziyancipha ngosayizi.
I-Embolic Microspheres ingalethwa ngama-microcatheter ajwayelekile ebangeni elingu-1.7- 4 Fr. Ngesikhathi sokusetshenziswa, i-Embolic Microspheres ixubene ne-nonionic ejenti yokungafani ukuze yenze isisombululo sokumiswa. Ama-Embolic Microspheres ahloselwe ukusetshenziswa kanye futhi ahlinzekwa ayinyumba futhi angeyona i-pyrogenic. Ukulungiselelwa kwedivayisi ye-Embolic Microsphere kuchazwe kuThebula 1 nakuThebula 2 ngezansi.
Phakathi kobubanzi obuhlukahlukene bosayizi be-Embolic Microspheres, ububanzi besayizi obungasetshenziswa ekuhlanganisweni kwe-uterine fibroid yi-500-700μm, 700-900μm kanye no-900-1200μm.
Table: Ukucushwa kwedivayisi ye-Embolic Microspheres
Iincazelo
Proumgudu
Ikhodi
Ilinganisiwe
Usayizi (µm)
Qubuthi
HyIzimila ze-pervascular/ Arteriovenous
Malformations
I-Uterine Fibroid
B107S103 100-300
I-1ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Cha
B107S305 300-500
I-1ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Cha
B107S507 500-700
I-1ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
B107S709 700-900
I-1ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
B107S912 900-1200
I-1ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
I-B207S103 100-300
I-2ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Cha
B207S305 300-500
I-2ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Cha
B207S507 500-700
I-2ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
B207S709 700-900
I-2ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
I-B207S912 900-1200
I-2ml microspheres: 7ml 0.9%
i-sodium chloride
Yebo Yebo
Proumgudu Ikhodi |
Ilinganisiwe Usayizi (µm) |
Qubuthi | Iincazelo | |
HyIzimila ze-pervascular/ Arteriovenous Malformations |
I-Uterine Fibroid | |||
I-U107S103 | 100-300 | 1ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | No |
I-U107S305 | 300-500 | 1ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | No |
U107S507 | 500-700 | 1ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |
U107S709 | 700-900 | 1ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |
I-U107S912 | 900-1200 | 1ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |
U207S103 | 100-300 | 2ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | No |
U207S305 | 300-500 | 2ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | No |
U207S507 | 500-700 | 2ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |
U207S709 | 700-900 | 2ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |
I-U207S912 | 900-1200 | 2ml ama-microspheres: 7ml 0.9% sodium chloride | Yebo | Yebo |