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1、TVT-O治疗女性压力性尿失禁治疗女性压力性尿失禁* Trademark 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+ 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 patien
2、ts 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.Complication US
3、Ex-US Total %血管损伤血管损伤 7 37 44 0.009 尿道磨损尿道磨损20 0 20 0.004肠损伤肠损伤16 12 28 0.006神经损伤神经损伤 3 1 4 0.0008血肿血肿 4 16 20 0.004Most Significant Reported Complications+Based on over 500,000 patients treated worldwide+ As of September 26, 2019, seven deaths are associated with GYNECARE TVT. Six cases were for bo
4、wel 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 ble
5、eding in the retropubic space. Professor Jean de Leval, Chairman of Urology at the University of Liege, Belgium 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)F1F1F2F2 Obturator Slings(Hammock Shaped)-Hammock shape of sling may resul
6、t 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 Consists of three major components GYNECARE TVT 经闭孔吊带
7、GYNECARE TVT 螺旋穿刺针 GYNECARE TVT 蝶型导引器Blister package Shown with TyvekLid removed吊带吊带锥形头的塑料管连于带锥形头的塑料管连于带 塑料外套的蓝色塑料外套的蓝色 普理灵网带普理灵网带塑料管和组件的材料塑料管和组件的材料- 聚乙烯聚乙烯 - 聚亚安酯聚亚安酯 塑料管直径塑料管直径4.2-4.8毫米毫米 (从尖锥部到底部从尖锥部到底部)螺旋穿刺针螺旋穿刺针 预先放置于塑料套内预先放置于塑料套内 固定在塑料套内固定在塑料套内 资料资料 聚碳酸酯的手柄聚碳酸酯的手柄 - 不锈钢穿刺针不锈钢穿刺针Bendable Tabs6
8、cm7 cm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 DesignWith left hand, grabHelical Passer forpatients right sideWinged Guide slidesout of workstation inthis directionWith right hand, grabHelical Passer forpatients left sideAfter grasping both handles andremoving, rotatehandles outward Holds He
9、lical Passer, Device, and Winged Guide Allows for dumping or aseptic transfer from Tyvek BlisterPatient orientationsymbolProduct Ordering Information Product Code: 810081Review of Procedural Steps& Anatomy病人体位和准备 截石位, 臀部和床边齐. 这样床的边缘不会干扰医生穿针的过程. 病人的大腿和腹部尽量保持垂直. 术前排空膀胱麻醉 手术可以在局麻, 硬膜外或全麻下进行. 如进行局麻, 术者必
10、须: 使用经稀释的,长效麻醉剂(同TVT) 在尿道中段处注射5-10毫升 在皮肤出针点注射5-10毫升 用硬膜外针,在螺旋穿刺针的路径注射10-20毫升 从阴道切口和皮肤出针点分别注射, 都朝向耻骨联合和耻骨降支处.Note: The above technique is from Vincent Lucente M.D. - GYNECARE does not recommend any particular anesthesia protocol. - 沿尿道口画一水平线, 第二条线为第一条线上两公分, 出针点为第二条线的大腿皱褶外两公分处. 可以现在就作皮肤切口.Mark the exi
11、t points by tracing a horizontal line at the level of the urethral meatus, and a second line parallel and 2cm above the first line. - Locate the exit points on this second line, 2cm lateral to the folds of the thigh . Optionally, skin incisions may be made at this time.- 用Allis钳牵夹, 在尿道口下一公分作一个一公分的切口
12、.Using Allis clamps for traction, make a 1cm midline vaginal incision starting 1cm proximal to the urethral meatusSTEP #1: 标记大腿根部的出针点和阴道正中切口- 锐性分离锐性分离Sharply dissect, using blade or sharp scissors (tenotomy or Metzenbaums not Mayo)- 钝性分离钝性分离, 使用前推使用前推-撑开技术向耻骨和耻骨降支的联合处分离撑开技术向耻骨和耻骨降支的联合处分离, 剪刀为水平略向上方向
13、剪刀为水平略向上方向, 角度为角度为45度角度角. Bluntly dissect, using a push-spread technique toward the junction between the body of the pubic bone and the inferiorpubic ramus, orienting scissors horizontally or pointed slightly upward, and at approx 45 degree angle (toward palpable junction) - 突破闭孔膜突破闭孔膜Perforate the
14、obturator membrane- 略微将剪刀撑大略微将剪刀撑大Spread scissors slightly apart STEP #2: 组织分离至闭孔膜并突破预备STEP #3:插入蝶型导引棒和螺旋穿刺针, 然后取走蝶型导引棒- 在剪刀的路径中插入蝶型导引棒在剪刀的路径中插入蝶型导引棒- Insert Winged Guide, into tract at same angle as scissors- 如果蝶型导引棒没有突破闭孔膜如果蝶型导引棒没有突破闭孔膜, 取出蝶型导引棒取出蝶型导引棒, 用剪刀重新分离用剪刀重新分离.- If Winged Guide does not “p
15、op” through obturator membrane, - Remove and reestablish tract using scissors - 蝶型导引棒放置好后蝶型导引棒放置好后, 插入螺旋穿刺针插入螺旋穿刺针, 针尖贴着蝶型导引棒的凹槽针尖贴着蝶型导引棒的凹槽.- With Winged Guide in place, insert Helical Passer, keeping tip in line with the channel of the Winged Guide- 压住螺旋穿刺针穿过闭孔膜压住螺旋穿刺针穿过闭孔膜, 感觉突破感感觉突破感.- Press Hel
16、ical Passer through obturator membrane, feeling “pop”- 取走蝶型导引棒取走蝶型导引棒- Remove Winged Guide-一边旋转穿刺针一边旋转穿刺针, 手柄部位同时移至中线位置手柄部位同时移至中线位置.Simultaneous rotation and centering of Helical Passer handle-在到达中间位置前不要转到手柄在到达中间位置前不要转到手柄, 和将手柄在水平位置移动和将手柄在水平位置移动.因为这样容易使穿刺针误入耻骨后因为这样容易使穿刺针误入耻骨后空间空间. Do NOT rotate hand
17、le prior to centering or orient handle in the horizontal plane, as either of these motions may increase the potential for the Helical Passer to enter the retropubic space(remember.POP, DROP & ROTATE)STEP #4: 旋转螺旋穿刺针直至手柄转到中间位置-螺旋穿刺针在靠近前面设定的出针点附近穿出螺旋穿刺针在靠近前面设定的出针点附近穿出. Helical Passer should exit near
18、the previously determined exit points.- 可能需要拉一下皮肤可能需要拉一下皮肤 Slight skin manipulation may be required.- 如果手术开始时没有作皮肤切口如果手术开始时没有作皮肤切口, 那么应该在此刻作皮肤切口那么应该在此刻作皮肤切口 If skin incisions were not created at start of procedure, they should be created now.STEP #5: 针尖传出皮肤切口- 针尖穿出皮肤后, 钳夹塑料管顶端- 稳住尿道处的塑料管 Stabilize t
19、he plastic tube near the urethra- Remove the Helical Passer by a reverse rotation of the handle, overcoming the detent holding the Plastic Tube to the Helical Passer. STEP #6:钳夹塑料管-反向转出穿刺针使用器械After clamping plastic tip with hemostat (not shown), place thumb at base of Plastic Tube (as shown below) a
20、nd rotate Helical Passer out of Device用止血钳夹住塑料管顶端, 用拇指握住塑料管的底部, 然后将螺旋穿刺针转出塑料管.-将塑料管和网带完整拉出皮肤直到网带露出, 而且塑料外套的靠近阴道切口.STEP #7: 将塑料管和网带完整拉出皮肤- 完成另一侧步骤后完成另一侧步骤后, 确保网带平放在尿道下确保网带平放在尿道下STEP #8: 在另一侧完成步骤2-7 -使用规范方式调整网带使用规范方式调整网带, 比如使用一个钝性器械比如使用一个钝性器械Use the standard method for tape adjustment, such as placing
21、 a blunt instrument between the tape and urethra- Close the vaginal incision. - Cut the tape ends at the exit points just below the skin of the inner thigh. Close the skin incisions with suture or DERMABOND* Topical Skin Adhesive STEP #9: 调整网带, 抽出塑料套, 缝合切口* Trademark完成手术TVT-O的组织分离路径 分离尿道旁组织 进入耻尾肌起始端后和闭孔内肌处的提肛肌弓状腱下的坐骨直肠窝的前凹处 Enter the anterior recess of the ischioanal fo
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