SOLITAIRE颅内支架PPT课件

1、颅内支架概览第1页/共130页颅内支架分类2第2页/共130页颅内辅助支架的作用问题：宽的瘤颈使得动脉瘤内的弹簧圈容易移位或部分脱出到载瘤动脉里，这可能造成严重的并发症。解决方案：颅内辅助支架主要用于辅助宽颈动脉瘤的弹簧圈栓塞，防止弹簧圈的移位或部分脱出。3第3页/共130页支架的基础知识与常用术语第4页/共130页5开环 vs. 闭环闭环设计开环设计“游离” 的尖端第5页/共130页6颅内支架不同的网眼设计Solitaire AB -闭环Leo Plus 闭环Neuroform 开环Enterprise 闭环未连接点第6页/共130页7输送性和可回收性 输送性：支架能够被输送到病变部位的能力

2、，尤其是通过远端病变或通过迂曲的解剖结构的能力。 可回收性：支架被释放后，可以被重新收回且被重新放置到更优位置的能力。这是一项非常重要的能力，分为完全回收和部分回收。第7页/共130页柔软性 Flexibility为柔软性，支架在闭合状态下随血管的弯曲而弯曲的能力。柔软性越好，支架的通过性越佳。8第8页/共130页9顺应性 Comfortability，支架在打开状态下随血管的弯曲而弯曲的能力。 顺应性好，有利于支架完全贴壁和保持血管的正常生理弯曲。 顺应性差可能导致血栓的形成第9页/共130页10支架的贴壁性 支架的贴壁性：支架与血管壁贴合的能力。 贴壁性不好可能导致血栓和支架移位的发生第1

3、0页/共130页径向支撑力 是支架对血管壁的支撑能力-决定支架对弹簧圈的支撑能力-衡量支架的稳定性和移位效应11第11页/共130页12开环 vs. 闭环第12页/共130页13毛刺现象和打折现象 毛刺现象：Gator-Backing，指支架被置于弯曲解剖处时，网丝向外扩张/伸出的趋势。类似鳄鱼背脊。 打折现象：支架的弯曲能力，弯曲能力差支架容易在弯曲处发生打折现象，容易造成血管的闭塞第13页/共130页14支架短缩？ 支架释放/撑开前后轴向上长度的差异 所有支架都有一定程度的短缩 取决于支架的材质和设计 对支架的精确释放有重要的意义，但. 如果支架可以完全回收重新放置， 4 mm 4 mm第

4、39页/共130页40操作图示支架的回收和重新释放支架回收：保持支架位置不动，小心推送微导管，直到支架全部收到微导管里。SOLITAIRE AB可以完全回收2次。第40页/共130页41操作图示-填弹簧圈将微导管（远端头端）通过支架网眼送入动脉瘤内，填圈。第41页/共130页解脱 使用NDS-2解脱盒Not available for sale in the United States第42页/共130页解脱原理 Covidien | October 23, 2021 | Confidential43 |Insertion Needle（钢针）Solitaire AB Detachment Z

5、one（支架解脱点）解脱点的金属结构在外部电流到达、然后离开的过程中发生电解腐蚀。如Solitaire AB的电流途径是：电流从解脱盒发出，到达支架解脱点；支架解脱点发生电解腐蚀；然后电流通过导电途径到达钢针。完整的电流回路是解脱的必要条件)（虽然钢针也接收到电流，但是由于有一定的保护，所以结构上不会受到影响）促进电流运动的因素：盐水冲洗1. 肌肉（+）（-）第43页/共130页44解脱盒参数 电压(9V) 电流1 mA 按钮：StopStartOnTimer显示解脱过程正消耗的时间 (分.秒). 最长解脱时间: 2分钟Not available for sale in the United

6、StatesThis is picture of NDS-1第44页/共130页45配件 连接线: -1副 消毒针(20 G or 22 G)Not available for sale in the United States第45页/共130页46Detachment ZoneDetachment ZonePushWireIntroducerSheathTotal LengthUsable LengthDistal MarkersProximal MarkerInternal Use onlyFor ev3 Inc. Presentation Use Only Not for Distri

7、bution46 Electrolytic DetachmentNot available for sale in the United States第46页/共130页47准备和检测 使用新电池: 电池指示灯常亮：电量足够 电池指示灯闪烁： 更换电池 将连接线接头插到解脱盒上，并旋紧确保连好。 打开开关On, 听到一短提示音 检测：按 Stop钮，所有数字显示 8.Not available for sale in the United States第47页/共130页48患者与器械的连接患者 将消毒针插在肩膀(或腹股沟处) 将“黑线”卡在钢针上。Solitaire 将“红线”卡在支架推送导

8、丝的近端无PTFE涂层处 暴露解脱点（确保微导管未覆盖支架解脱点）。Not available for sale in the United States第48页/共130页49解脱按“Start”开始解脱电压框显示解脱电压(0.0 to 9.9 volts).如果电压显示0.0 伏, 可能有短路存在，请重新检查连接如解脱成功，则：解脱盒发出周期性重复的报警声“Detach” 灯常亮或解脱2分钟后，解脱盒发出周期性重复的报警声Not available for sale in the United States第49页/共130页操作动画50第50页/共130页51成功的支架释放Detache

9、d StentNot available for sale in the United States第51页/共130页52SOLITAIRE AB的输送与输送弹簧圈一样简便，最小使用ID 0.021”的微导管输送。柔软性好，易于通过迂曲的血管。使用简便支架应用第52页/共130页53支架应用Distal markersProximal marker辅助支撑弹簧圈 贴壁性好 径向支撑力好 可视性佳第53页/共130页磁共振成像相容性 October 23, 2021 | Confidential54 |第54页/共130页异议处理Not available for sale in the Un

10、ited States第55页/共130页56 防止填圈过程中支架解脱 假阳性解脱（未解脱） 假阴性解脱（解脱了）Not available for sale in the United States第56页/共130页57防止填圈过程中支架解脱如希望在填圈后解脱支架，则手术过程中可以: 用微导管覆盖支架解脱点 在解脱弹簧圈时，用干布覆盖推送导丝近端（体外）-如果导丝交叉可能出现交叉电流，导致支架过早解脱。避免推送导丝交叉干布覆盖支架推送导丝Not available for sale in the United States第57页/共130页58假阳性解脱（未解脱） 解脱盒已经报警显示解脱

11、，但实际上未解脱Not available for sale in the United States第58页/共130页解脱的优化方法： 解脱前： 消毒针插在患者肩膀或颈部。在针头处滴几滴生理盐水。 消毒针插在肌肉层里。 使用9V新电池。 使用新电解线。59第59页/共130页优化方法： 解脱中： 确保微导管中持续快速滴注生理盐水 避免消毒针插在脂肪层 支架近端标记与微导管远端标记之间距离2mm 支架推送导丝近端在干燥的操作台表面 确保卸掉微导管与支架推送导丝上的力量60第60页/共130页国外医生经验 方法： 针头处滴几滴生理盐水 按Stop 重置，按Start 再次解脱 换用BSC的解脱

12、器61第61页/共130页62假阴性释放（解脱了） 医生看到支架解脱但解脱盒10秒后仍未报警 (解脱盒设定程序为解脱后5秒报警）: 建议等待解脱时间至2分钟，透视下辨别Not available for sale in the United States第62页/共130页中断解脱Not available for sale in the United States第63页/共130页64中断解脱并继续解脱 按“STOP”可以中断 “timer”停止计时 电流(0.0 mA) 和电压 (“-.-”) 被切断. 重新开始请短按 ( will have to jail the catheter P

13、otential of coil herniation Comparison: Solitaire AB maintains better wall apposition than Enterprise and Neuroform第96页/共130页97Gator-BackingSolitaire AB 4x20第97页/共130页98KinkingSolitaire AB 4x20第98页/共130页99Gator-Backing and Kinking For some physicians this is important, for others it is nice-to-know

14、though wouldnt stop them from using a stent they like. Clinical relevance: May result in coil herniation Unlikely that kinking will result in vessel occlusion, though it might limit catheter access Comparison: Gator-backing and kinking not observed in Solitaire AB and Enterprise第99页/共130页100Stent Ce

15、ll Area第100页/共130页101Stent Cell Size第101页/共130页102Cell area and size Physicians would like to know both data Clinical relevance: Want to know whole area for potential coil herniation The size is important for catheter size to be able to go thru Comparison: Able to place a 3 mm stent through Solitair

16、e AB for bifurcation / Y-stenting, while other stents have much smaller cell size A catheter diameter of 3 mm can cross Solitaire, while a catheter diameter of 1.3 mm can cross the Enterprise. The largest catheter that can pass through in Solitaire is 8F. This is larger than most devices used in neu

17、rovascular intervention. Solitaire AB cell length is similar to Enterprise, though Solitaire is twice as wide, therefore cell area of Solitaire is twice as large.第102页/共130页103Working area foreshorteningWorking area of Solitaire AB does not foreshorten第103页/共130页104Delivery method Solitaire AB: Devi

18、ce attached to pushwire, loaded into a sheath. Pushed through entire catheter. Electrolytic detachment. Enterprise: Device is loaded into a sheath, loaded over the guidewire and pushed through the entire catheter. Device is released from the guidewire when released from the catheter. Neuroform and W

19、ingspan: Device loaded over polymer tube and preloaded at tip of catheter. Guidewire access through polymer tube. Device is released when catheter is pulled back. Leo: Device hooked onto pushwire, loaded into a sheath. Pushed through entire catheter. Device detaches when pushwire tip exits catheter

20、and unhooks from device.第104页/共130页105Delivery method Clinical relevance: Solitaire AB is easy to use, delivers like a coil, no extra steps needed. Disadvantage is potential loss of guidewire access. Stent needs to be able to be delivered at the right place Comparison: Physicians will choose stents

21、based on aneurysm size and location, stent and delivery characteristics. It is important to understand of your physician what he takes into configuration and how Solitaire will work in his practice.第105页/共130页Market Overview第106页/共130页107Projected Market size第107页/共130页108Estimated Market Overview第1

22、08页/共130页109Outlook Solitaire ABPotential risks: Product availability Full range of sizes Flow Diversion第109页/共130页Stents and Balloons第110页/共130页111StentsAdvantages Straight forward and easy procedure Small risk of coil herniation Choice between coiling thru the struts or jailing the catheter. Can p

23、ut stent in a few days before coiling and let it endothelialize If a loop pops out, you only have to pull out that specific coil第111页/共130页112StentsDisadvantages Permanent foreign body in the brain, no long-term results available yet Need life-time medication to minimize in-stent restenosis or throm

24、bosis Stent can jump Difficulty deploying the stent in tortuous environment Several stents might be necessary to cover the neck (stent in stent technique) Safety: Risk of catheter stuck in stent第112页/共130页113BalloonsAdvantages Prevents misplacement of coils and reduces risk of ischemic events After

25、procedure no foreign material remains in vessel Safety: No need to place catheter deep in AN for coil delivery In case of rupture, a placed balloon allows for immediate hemorrhage control Allows coverage of complex and difficult located wide neck aneurysms Usually no meds needed (even though some ph

26、ysicians prefer to give Plavix and / or aspirin)第113页/共130页114Balloons Assisted Coiling HyperGlide/HyperFormDisadvantages No permanent barrier Procedure increases in complexity and duration Training required Need to control the inflation and deflation Instability, balloon can jump Blood can re-enter

27、 the AN, increasing the pressure and leading to potential AN rupturing Can only see after balloon has been removed and all coils delivered, if a loop pops out. If so all coils will have to be pulled out.第114页/共130页115Strategic Implications Its not (necessarily) an either / or story Stent or Balloon

28、can be used in most cases Engage the discussion with your physician ! Highlight benefits of both and how they can work complementary ACOMM : rarely treated w/o balloon PCOMM : balloon and stent work well 第115页/共130页116Key Messages “Fully deployable. Completely retrievable.” Ease in delivery Accuracy

29、 and deployment control Optimal coil mass support Electrolytic detachment第116页/共130页117Sales Tools Available Q1: Brochure Competitive overview In-service presentation Case study booklet Website Targeted in Q2: Wall chart CD with video on preparation, deployment and detachment Sales Contest Booth gra

30、phics第117页/共130页118Brochure, page 1第118页/共130页119Brochure, page 2第119页/共130页120第120页/共130页121第121页/共130页122Revenue objectives第122页/共130页123Objectives 2009 Increase awareness / drive adoption: Publications KOL management User meetings Podium presence Marketing materials Sales training Start Registry第

31、123页/共130页124KOL KOLs for Solitaire AB:Dr. BattacharyaDr. BoccardiProf. HenkesProf. KlischDr. LiebigProf. Turjman KOL and User meetingsLINNC MayESMINTSeptember Podium presentations:Val dIsereLINNCWFITNESMINTICS第124页/共130页125UK Case StudyBackground: Stent market was not very well developed Bad experience with Neuroform and Leo Enterprise came in and took whole market第125页/共130页126UK Success Factors Product leverage: Retrievability / repositionability Y-stenting 4 x 20- one size fits all