SOLITAIRE颅内支架

1、For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely Retrievable75646 (A) DEC/07“Confidential, For Internal ev3, Inc. Use On

2、ly, Do Not Distribute”“Not approved for sale in the United States” For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely Retr

3、ievable颅内支架概览“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable颅内支架分类3 3“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in t

4、he United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable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。4 4For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, Fo

5、r Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely Retrievable支架的基础知识与常用术语“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Dep

6、loyed. Completely Retrievable6开环 vs. 闭环闭环设计开环设计“游离” 的尖端6“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable7颅内支架不同的网眼设计Solitaire AB -闭环Leo Plus 闭环Neuroform 开环Enterpri

7、se 闭环未连接点7“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable8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，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

8、收和部分回收。8“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable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。9 9“Confidential, For Internal ev3, Inc. Use Only,

9、Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable10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10“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approv

10、ed for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable11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11“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales Tra

11、iningFully Deployed. Completely Retrievable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1212“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable13开环 vs. 闭环开环闭环Solitai

12、re AB径向支撑力中/低高高柔软性/顺应性高低高打折和毛刺现象毛刺现象明显光滑光滑支架的结构性支撑好更好最优13“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable14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

13、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14“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable15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

14、意义，但. 如果支架可以完全回收重新放置， 4 mm 4 mm40“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable41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。41“Confide

15、ntial, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable42操作图示-填弹簧圈将微导管（远端头端 2.5F）通过支架网眼送入动脉瘤内，填圈。42For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sa

16、les Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely Retrievable解脱 使用NDS-2解脱盒CR00049 Rev.BNot available for sale in the United States“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not

17、 approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable解脱原理 Covidien | October 22, 2021 | Confidential44 |Insertion Needle（钢针）Solitaire AB Detachment Zone（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

18、；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：1. 盐水冲洗2. 肌肉（+）（-）44“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable45解脱盒参数 电压(9V) 电流1

19、 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CR00049 Rev.BNot available for sale in the United StatesThis is picture of NDS-145“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. C

20、ompletely Retrievable46配件 连接线: -1副 消毒针(20 G or 22 G)CR00049 Rev.BNot available for sale in the United States46“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable47Det

21、achment ZoneDetachment ZonePushWireIntroducerSheathTotal LengthUsable LengthDistal MarkersProximal MarkerInternal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution47 Electrolytic DetachmentCR00049 Rev.BNot available for sale in the United States47“Confidential, For Internal ev3, Inc. U

22、se Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable48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.CR00049 Rev.BNot available for sale in the United Stat

23、es48“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable49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）。CR00049 Rev.BNo

24、t available for sale in the United States49“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable50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

25、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.ProductSolitaire ABSolitaire_AB.exeCR00049 Rev.BNot available for sale in the United States50“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFul

26、ly Deployed. Completely Retrievable操作动画 .ProductSolitaire ABSolitaire_AB.exe5151“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable52成功的支架释放Detached StentCR00049 Rev.

27、BNot available for sale in the United States52“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable53SOLITAIRE 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

28、应用53“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable54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54“Confidential, For Internal ev3, Inc. Use Only, Do

29、 Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable磁共振成像相容性 October 22, 2021 | Confidential55 |55For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal

30、ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely Retrievable异议处理CR00049 Rev.BNot available for sale in the United States“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076

31、International Sales TrainingFully Deployed. Completely Retrievable57 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）CR00049 Rev.BNot available for sale in the United States57“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales T

32、rainingFully Deployed. Completely Retrievable58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CR00049 Rev.BNot available for sale in the United States58“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sa

33、le in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable59假阳性解脱（未解脱） 解脱盒已经报警显示解脱，但实际上未解脱CR00049 Rev.BNot available for sale in the United States59“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States”

34、CR00076 International Sales TrainingFully Deployed. Completely Retrievable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。6060“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully De

35、ployed. Completely Retrievable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6161“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Comple

36、tely Retrievable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的解脱器6262“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable63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

37、解脱后5秒报警）: 建议等待解脱时间至2分钟，透视下辨别CR00049 Rev.BNot available for sale in the United States63For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deploy

38、ed. Completely Retrievable中断解脱CR00049 Rev.BNot available for sale in the United States“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable65中断解脱并继续解脱 按“STOP”可以中断 “time

39、r”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 Potential of coil herniationComparison: Solitaire AB maintains better wall apposition than Enterprise and Neuroform97“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United Stat

40、es” CR00076 International Sales TrainingFully Deployed. Completely Retrievable98Gator-BackingNeuroform3 3.5x20Leo 3.5x25Solitaire AB 4x20Enterprise 4.5x22Wingspan 3.5x1598“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 Internatio

41、nal Sales TrainingFully Deployed. Completely Retrievable99KinkingSolitaire AB 4x20Enterprise 4.5x22Leo 3.5x25Neuroform3 3.5x20Wingspan 3.5x1599“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Depl

42、oyed. Completely Retrievable100Gator-Backing and KinkingFor some physicians this is important, for others it is nice-to-know 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

43、limit catheter accessComparison: Gator-backing and kinking not observed in Solitaire AB and Enterprise100“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable101Stent C

44、ell Area101“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable102Stent Cell Size102“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for

45、 sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable103Cell area and sizePhysicians would like to know both dataClinical relevance: Want to know whole area for potential coil herniation The size is important for catheter size to be able to go thruCom

46、parison: Able to place a 3 mm stent through Solitaire 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

47、 is 8F. This is larger than most devices used in neurovascular intervention. Solitaire AB cell length is similar to Enterprise, though Solitaire is twice as wide, therefore cell area of Solitaire is twice as large.103“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for

48、 sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable104Working area foreshorteningDeviceSize (mm)Foreshortening (%)Enterprise4.5 x 156.74. 5 x 227.74.5 x 289.84.5 x 3710.9Neuroform 34 x 205.4Solitaire AB4 x 2015.36 x 3018.1Working area of Solitaire A

49、B does not foreshorten104“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable105Delivery methodSolitaire AB: Device attached to pushwire, loaded into a sheath. Pushed

50、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 Wingspan: Device loaded over polymer tube and preloaded a

51、t 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 and unhooks from device.105“Confidential, For Internal ev

52、3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable106Delivery methodClinical relevance: Solitaire AB is easy to use, delivers like a coil, no extra steps needed. Disadvantage is potential loss of

53、 guidewire access. Stent needs to be able to be delivered at the right placeComparison: Physicians will choose stents 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

54、in his practice.106For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deployed. Completely RetrievableMarket Overview“Confidential, For Interna

55、l ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable108Projected Market size108“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR0

56、0076 International Sales TrainingFully Deployed. Completely Retrievable109Estimated Market Overview109“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable110Outlook So

57、litaire ABPotential risks: Product availability Full range of sizes Flow Diversion110For ev3 Inc. Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” Fully Deploye

58、d. Completely RetrievableStents and Balloons“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable112StentsAdvantagesStraight forward and easy procedureSmall risk of coi

59、l herniationChoice between coiling thru the struts or jailing the catheter.Can put stent in a few days before coiling and let it endothelializeIf a loop pops out, you only have to pull out that specific coil112“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale i

60、n the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable113StentsDisadvantagesPermanent foreign body in the brain, no long-term results available yetNeed life-time medication to minimize in-stent restenosis or thrombosisStent can jumpDifficulty deploying the st