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1、,TVT-O治疗女性压力性尿失禁,* Trademark,GYNECARE TVT* Tension-free Support for Incontinence TVT尿失禁无张力支持,TVT的尿道中段悬吊已经成为“金标准” Long-term, seven year follow-up data presented at 2003 IUGA reported+ Cure rate of 81% Significantly improved rate of 16% Comparable to 5 year data of 85% / 11% respectively Very low rate

2、s of reported major complications in over 500,000 patients Reported bowel injury less than 6 / 100,000 procedures Reported major vascular injury less than 9 / 100,000 procedures,+ Nilsson, et. al, 7 Year Follow-up of the Tension-free Vaginal Tape (TVT) Procedure; International Urogynecology Journal,

3、 IUGA Abstract # 116 (89); October, 2003.,Complications Statement,Complication US Ex-US Total % 血管损伤 7 37 44 0.009 尿道磨损20 0 20 0.004 肠损伤16 12 28 0.006 神经损伤 3 1 4 0.0008 血肿 4 16 20 0.004,Most Significant Reported Complications+ Based on over 500,000 patients treated worldwide,+ As of September 26, 20

4、03, seven deaths are associated with GYNECARE TVT. Six cases were for bowel perforation. Five were associated with undiagnosed bowel perforations at the time of surgery. In the sixth case of bowel perforation, no additional information could be obtained. The seventh case was associated with a woman

5、who had a bleeding disorder who died from uncontrolled postoperative bleeding in the retropubic space.,Concept Development of GYNECARE TVT Obturator,Professor Jean de Leval, Chairman of Urology at the University of Liege, Belgium,为什么经闭孔?,避开耻骨后空间可能带来的好处 减少膀胱穿孔,尤其对有手术史的病人 避免耻骨后血肿 避免肠穿孔 减少大血管的损伤 悬吊带方向的

6、改变可能带来的好处 减少术后尿潴留的发生率 手术时间更短,Retropubic Slings (“U” shaped),F2,F2,Obturator Slings (Hammock Shaped),“U” Shape vs. Hammock Shape,Hammock shape of sling may result in less obstructive symptoms and/or de novo urgency, since it is harder to overcompress the urethra 悬吊带方向的改变减少梗阻的发生和术后急迫症状 However, this m

7、ay also make it more difficult to correct certain patients, such as those with ISD 但是,对于ISD的病人可能不能完全纠治,GYNECARE TVT Obturator System,Consists of three major components GYNECARE TVT 经闭孔吊带 GYNECARE TVT 螺旋穿刺针 GYNECARE TVT 蝶型导引器,Blister package Shown with Tyvek Lid removed,GYNECARE TVT Obturator System,

8、吊带 锥形头的塑料管连于带 塑料外套的蓝色 普理灵网带 塑料管和组件的材料 - 聚乙烯 - 聚亚安酯 塑料管直径4.2-4.8毫米 (从尖锥部到底部),螺旋穿刺针 预先放置于塑料套内 固定在塑料套内 材料 聚碳酸酯的手柄 - 不锈钢穿刺针,Bendable Tabs,6 cm,7 cm,GYNECARE TVT Obturator System,蝶型导引器有助于螺旋穿刺针准确一致地穿过组织 6公分长, 可以延长至7公分.,Workstation Design,With left hand, grab Helical Passer for patients right side,Winged G

9、uide slides out of workstation in this direction,With right hand, grab Helical Passer for patients left side,After grasping both handles and removing, rotate handles outward,Holds Helical Passer, Device, and Winged Guide Allows for dumping or aseptic transfer from Tyvek Blister,Patient orientation symbol,Product Ordering Information,Product Code: 810081,Review of Procedural Steps de Leval, Jean.; European Urology, 2003; 44(6), 724-730. 107 consecutive patients (mean age=62 years) Mean operative time of 14 minutes (range=7-20 min) No bladder or urethral i

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