SOLITAIRE颅内支架介入治疗

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”,“Not approved for sale in the United States”,CR00076 International Sales Training,Fully Deployed. Completely Retrievable,For ev3 Inc. Presentation Use Only Not for Distribution,CR00076 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,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,75646 (A) DEC/07,“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”,“Not approved for sale in the United States”,颅内支架概览,颅内支架分类,3,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,支架的基础知识与常用术语,6,开环,vs.,闭环,闭环设计,开环设计,“,游离,”,的尖端,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,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。,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。,9,10,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,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,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,12,13,开环,vs.,闭环,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,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,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。,42,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。,解脱,使用,NDS-2,解脱盒,Not available for sale in the United States,解脱原理,Covidien |,29 September 2024,| Confidential,44,|,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：,盐水冲洗,肌肉,（,+,）,（,-,）,45,解脱盒参数,电压,(9V),电流,1 mA,按钮：,Stop,Start,On,Timer,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 States,This is picture of NDS-1,46,配件,连接线,:,-1,副,消毒针,(20 G or 22 G),Not available for sale in the United States,47,Detachment Zone,Detachment Zone,Push,Wire,Introducer,Sheath,Total Length,Usable Length,Distal Markers,Proximal Marker,Internal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution,47,Electrolytic Detachment,Not available for sale in the United States,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.,Not available for sale in the United States,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）。,Not available for sale in the United States,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,Not available for sale in the United States,操作动画,51,52,成功的支架释放,Detached Stent,Not available for sale in the United States,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,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,磁共振成像相容性,29 September 2024,| Confidential,55,|,异议处理,Not available for sale in the United States,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）,Not available for sale in the United States,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,Not available for sale in the United States,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,Not available for sale in the United States,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,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,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,62,63,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,Not available for sale in the United States,中断解脱,Not available for sale in the United States,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,98,Gator-Backing,Solitaire AB 4x20,99,Kinking,Solitaire AB 4x20,100,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,101,Stent Cell Area,102,Stent Cell Size,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.,104,Working area foreshortening,Working area of Solitaire AB does not foreshorten,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.,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.,Market Overview,108,Projected Market size,109,Estimated Market Overview,110,Outlook Solitaire AB,Potential risks:,Product availability,Full range of sizes,Flow Diversion,Stents and Balloons,112,Stents,Advantages,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,113,Stents,Disadvantages,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,114,Balloons,Advantages,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),115,Balloons Assisted Coiling HyperGlide/HyperForm,Disadvantages,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.,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,117,Key Messages,“Fully deployable. Completely retrievable.”,Ease in delivery,Accuracy and deployment control,Optimal coil mass support,Electrolytic detachment,118,Sales 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 graphics,119,Brochure, page 1,120,Brochure, page 2,121,122,123,Revenue objectives,124,Objectives 2009,Increase awareness / drive adoption:,Publications,KOL management,User meetings,Podium presence,Marketing materials,Sales training,Start Registry,125,KOL,KOLs for Solitaire AB:,Dr. Battacharya,Dr. Boccardi,Prof. Henkes,Prof. Klisch,Dr. Liebig,Prof. Turjman,KOL and User meetings,LINNC May,ESMINTSeptember,Podium presentations:,Val dIsere,LINNC,WFITN,ESMINT,ICS,126,UK Case Study,Background:,Stent market was not very well developed,Bad experience with Neuroform and Leo,Enterprise came in and took whole market,127,UK Success Factors,Product leverage:,Retrievability / repositionability,Y-stenting,4 x 20- one size fits all,Develop experts:,Designated sales expert who is at almost every case,Physician expert Dr. Bhattacharya,Clinical and technical resource,Peer to peer selling proctering,Reps have to be there for the first case:,Rep sells trunk stock,Set up expectations before the case,128,UK Success Factors,Become known as the Y-stenting company,Physicians will save cases for Solitaire AB,Huge opportunity for cross sell:,Rebar, wire, Axium,Solitaire AB lets you sell more coils!,Reps sit down with physician before every elective case:,Discuss case and use of Solitaire AB,Discuss and sell other ev3 products,We have all the products in the bag for a wide-neck AN,129,UK Success Factors,Sales scenario:,Rep attends case and takes 3 - 4 stents with him,When case is finished, immediately sells 2 more stents,Book next case right there,130,UK Success Factors,Reps motivated to sell:,High revenue per case due to high ASP Solitaire AB and cross sell opportunity,Milestones on amount of Solitaire AB units to be sold,