7
37
44 0.009
20
0
20 0.004
16ห้องสมุดไป่ตู้
12
28 0.006
3
1
4 0.0008
4
16
20 0.004
++ As of September 26, 2019, 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 who had a bleeding disorder who died from uncontrolled postoperative bleeding in the retropubic space.
Complications Statement
Most Significant Reported Complications++ Based on over 500,000 patients treated worldwide
Complication 血管损伤 尿道磨损 肠损伤 神经损伤 血肿
US Ex-US Total %
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 2019 IUGA reported+
• Holds Helical Passer, Device, and Winged Guide • Allows for dumping or aseptic transfer from Tyvek Blister
Patient orientation symbol
With left hand, grab Helical Passer for patient’s right side
• 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, IUGA Abstract # 116 (89); October, 2019.
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
• Cure rate of 81% • Significantly improved rate of 16% • Comparable to 5 year data of 85% / 11% respectively
▪ Very low rates of reported major complications in over 500,000 patients
Retropubic Slings (“U” shaped)
F1
F1
Obturator Slings (Hammock Shaped)
F2
F2
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
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
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.
Bendable Tabs
6 cm
7 cm
Workstation Design
▪ 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
“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 may 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
•
Blister package Shown with Tyvek Lid removed
GYNECARE TVT Obturator System
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)