SOLITAIRE颅内支架课件.ppt

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 Retrievable 75646 (A) DEC/07 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 Retrievable 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 “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 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 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 Deployed. Completely Retrievable 6 开环 vs. 闭环 闭环设计 开环设计“游离” 的尖端 “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 7 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 “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 8 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，分为完全回收和部分回收。 “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 “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 10 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 “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 11 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 “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 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 12 “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 13 开环 vs. 闭环 开环 闭环 Solitaire 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 “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 14 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 “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 15 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 “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 41 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。 “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 42 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。 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 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 approved for sale in the United States” CR00076 International Sales TrainingFully Deployed. Completely Retrievable 解脱原理 Covidien | June 10, 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；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 （+）（-） “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 45 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 CR00049 Rev.BNot available for sale in the United States This is picture of NDS-1 “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 46 配件 连接线: -1副 消毒针(20 G or 22 G) 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 Retrievable 47 Detachment Zone Detachment ZonePush Wire IntroducerSheathTotal LengthUsable LengthDistal Markers Proximal MarkerInternal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution 47 Electrolytic DetachmentCR00049 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 Retrievable 48 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 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 Retrievable 49 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.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 Retrievable 50 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.ProductSolitaire ABSolitaire_AB.exeCR00049 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 Retrievable 操作动画 .ProductSolitaire ABSolitaire_AB.exe 51 “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 52 成功的支架释放 Detached Stent 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 Retrievable 53 SOLITAIRE 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 “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 54 支架应用 Distal markers Proximal marker辅助支撑弹簧圈 贴壁性好 径向支撑力好 可视性佳 “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 磁共振成像相容性 June 10, 2021 | Confidential55 | 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 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 International Sales TrainingFully Deployed. Completely Retrievable 57 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 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 Retrievable 58 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 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 Retrievable 59 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 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 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。 60 “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 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 61 “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 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 62 “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 63 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 CR00049 Rev.BNot available 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 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 Retrievable 65 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 Potential of coil herniation Comparison: Solitaire AB maintains better wall apposition than Enterprise and Neuroform “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 98 Gator-Backing Neuroform3 3.5x20 Leo 3.5x25 Solitaire AB 4x20Enterprise 4.5x22 Wingspan 3.5x15 “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 99 Kinking Solitaire AB 4x20 Enterprise 4.5x22 Leo 3.5x25 Neuroform3 3.5x20 Wingspan 3.5x15 “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 100 Gator-Backing and Kinking For 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 limit catheter access Comparison: Gator-backing and kinking not observed in Solitaire AB and Enterprise “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 101 Stent Cell Area “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 102 Stent Cell Size “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 103 Cell 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 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 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. “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 104 Working area foreshorteningDevice Size (mm) Foreshortening (%)Enterprise 4.5 x 15 6.74. 5 x 22 7.74.5 x 28 9.84.5 x 37 10.9Neuroform 3 4 x 20 5.4 Solitaire AB 4 x 20 15.36 x 30 18.1Working area of Solitaire AB does not foreshorten “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 105 Delivery method Solitaire AB: Device 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 Wingspan: 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 and unhooks from device. “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 106 Delivery 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 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. 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 Retrievable Market Overview “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 108 Projected Market size “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 109 Estimated Market Overview “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 110 Outlook Solitaire ABPotential risks: Product availability Full range of sizes Flow Diversion 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 Retrievable Stents 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 Retrievable 112 StentsAdvantages Straight forward and easy procedure Small risk of coil herniation Choice between coiling thru the struts or jailing the catheter. Can put 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 “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 113 StentsDisadvantages Permanent foreign body in the brain, no long-term results available yet Need life-time medication to minimize in-stent restenosis or thrombosis 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 “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 114 BalloonsAdvantages Prevents misplacement of coils and reduces risk of ischemic events After 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 physicians prefer to give Plavix and / or aspirin) “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 115 Balloons 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 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. “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 116 Strategic Implications Its not (necessarily) an either / or story Stent or Balloon 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 “Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved f