SOLITAIRE颅内支架介入治疗

75646 (A) DEC/07,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，20%的短缩率是可以接受的(如Solitaire AB)如果支架不能回收和重新放置，就需要有更低的短缩率,16,金属/血管比？,在覆盖支架的血管部位，支架的金属表面积/血管表面积该指标目前尚不能用于反映颅内支架的性能低金属/血管比可能降低管壁的不良反应。,17,潜在并发症1,支架内再狭窄（In-stent restenosis）: 狭窄是血管腔的变窄或阻塞。当支架植入血管后，血管壁的内皮被损伤，机体对损伤进行一系列主动修复。虽然此种修复是必要的，但在一些情况下，这种修复可能过度-过度的修复可能导致疤痕组织在支架内聚集，导致血管腔的狭窄或阻塞，这称为“支架内再狭窄”。可能导致脑缺血性损伤。,18,潜在并发症2,血栓（thrombosis）: 支架植入后，可能导致血栓形成。-急性、亚急性-迟发型可能导致脑缺血性卒中。,19,潜在并发症3,支架移位边支闭塞其他.,Solitaire AB产品信息,21,*Not approved for sale in the United States.,Internal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution,21,22,产品结构图,解脱点,推送导丝,导入鞘,全长,有用长度,远端标记,近端标记,Internal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution,22,Solitaire AB的产品特点,23,24,输送,推送导丝: 0.016” 的推送导丝，同弹簧圈的推送一样简便微导管4mm支架使用0.021” Rebar6mm支架使用0.027” Rebar输送和释放可一人操作可用于远端和迂曲的血管,25,产品型号,至少保证支架释放后能够覆盖瘤颈两端各4mm的距离，即有用长度至少超出瘤颈宽度8mm,26,支架短缩,短缩主要发生在尺寸较大的血管里Solitaire AB的短缩主要发生在近端 有用长度不发生短缩 回收区是发生短缩的主要位置，释放后 先确保支架远端准确覆盖了动脉瘤远端4mm，释放，瘤颈近端也可以达到4mm的覆盖。,Solitaire AB 支架重叠 - 4 mm,27,支架重叠的中点正对支架近端标记.,28,Solitaire AB 支架重叠 - 6 mm,29,支架网眼重叠试验1st释放,C,0.99,1.69,1.34,0.25,0.67,1.45,0.95,Cell A,0.65,Cell B,Cell C,A,B,30,支架网眼重叠试验2nd释放,A,C,B,0.72,1.10,0.95,Cell A,0.34,0.82,0.91,1.15,1.44,1.77,Cell B,Cell C,31,支架网眼重叠试验3rd释放,A,B,C,0.43,0.97,0.97,Cell A,0.32,0.61,0.69,Cell B,1.77,1.90,2.62,Cell C,32,解脱,Solitaire AB 使用NDS-2解脱盒电解脱. 解脱时:轻微回撤微导管，暴露解脱点保持微导管在解脱点近端1-2mm处可以在填圈前或后解脱,支架操作过程,34,器械尺寸选择,根据病变情况参考说明书选择SOLITAIRE AB及微导管 :Solitaire AB与Rebar配合使用 支架尺寸1）直径：参考目标血管节段的近端、远端的较大直径尺寸2）长度：需要保证其有用长度能够覆盖动脉瘤颈两端各4mm的距离。,操作动画（可替代操作图示）,.ProductSolitaire ABSolitaire_AB.exe,35,36,操作-微导管到位,推送微导管到合适的位置：确保当支架释放后，支架两端能够覆盖瘤颈两端各4mm的距离。,37,操作图示插入支架,将导引鞘部分插入RHV旋紧RHV持续滴注，确认可见液体从导引鞘近端流出,37,38,操作图示插入支架,旋松RHV推送导引鞘直到稳定在微导管的卡口处旋紧RHV轻柔的向前推送the SOLITAIRE AB 进入微导管,38,39,操作图示支架到位和释放,当支架推送导丝的柔软部分完全进入微导管的尾端，撤掉导引鞘一直推送SOLITAIRE AB 直到支架远端标记到达微导管的末端，确保在支架释放后，能够充分覆盖瘤颈两端至少4mm的距离。注：推送过程中如遇很大阻力请停止推送,40,操作图示支架到位和释放,保持支架位置不动，小心回撤微导管，释放支架。为达到支架的充分释放，微导管需要撤到支架近端标记的近端。,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 2.5F）通过支架网眼送入动脉瘤内，填圈。,解脱 使用NDS-2解脱盒,CR00049 Rev.B,Not available for sale in the United States,解脱原理,Covidien | December 12, 2017 | 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：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.B,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),CR00049 Rev.B,Not available for sale in the United States,47,Detachment Zone,Detachment Zone,PushWire,IntroducerSheath,Total Length,Usable Length,Distal Markers,Proximal Marker,Internal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution,47,Electrolytic Detachment,CR00049 Rev.B,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.,CR00049 Rev.B,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）。,CR00049 Rev.B,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.ProductSolitaire ABSolitaire_AB.exe,CR00049 Rev.B,Not available for sale in the United States,操作动画,.ProductSolitaire ABSolitaire_AB.exe,51,52,成功的支架释放,Detached Stent,CR00049 Rev.B,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,December 12, 2017 | Confidential,55 |,异议处理,CR00049 Rev.B,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）,CR00049 Rev.B,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。,干布覆盖支架推送导丝,CR00049 Rev.B,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,CR00049 Rev.B,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,CR00049 Rev.B,Not available for sale in the United States,中断解脱,CR00049 Rev.B,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 catheterPotential of coil herniationComparison:Solitaire AB maintains better wall apposition than Enterprise and Neuroform,98,Gator-Backing,Neuroform3 3.5x20,Leo 3.5x25,Solitaire AB 4x20,Enterprise 4.5x22,Wingspan 3.5x15,99,Kinking,Solitaire AB 4x20,Enterprise 4.5x22,Leo 3.5x25,Neuroform3 3.5x20,Wingspan 3.5x15,100,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 herniationUnlikely that kinking will result in vessel occlusion, though it might limit catheter accessComparison: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 dataClinical relevance:Want to know whole area for potential coil herniationThe size is important for catheter size to be able to go thruComparison:Able to place a 3 mm stent through Solitaire AB for bifurcation / Y-stenting, while other stents have much smaller cell sizeA 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 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 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,AdvantagesStraight forward and easy procedureSmall risk of coil 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 coil,113,Stents,DisadvantagesPermanent 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 stent in tortuous environmentSeveral stents might be necessary to cover the neck (stent in stent technique)Safety:Risk of catheter stuck in stent,114,Balloons,AdvantagesPrevents misplacement of coils and reduces risk of ischemic eventsAfter procedure no foreign material remains in vesselSafety:No need to place catheter deep in AN for coil deliveryIn case of rupture, a placed balloon allows for immediate hemorrhage controlAllows coverage of complex and difficult located wide neck aneurysmsUsually no meds needed (even though some physicians prefer to give Plavix and / or aspirin),115,Balloons Assisted Coiling HyperGlide/HyperForm,DisadvantagesNo permanent barrierProcedure increases in complexity and durationTraining requiredNeed to control the inflation and deflationInstability, balloon can jumpBlood can re-enter the AN, increasing the pressure and leading to potential AN rupturingCan 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 storyStent or Balloon can be used in most casesEngage the discussion with your physician !Highlight benefits of both and how they can work complementary ACOMM : rarely treated w/o balloonPCOMM : balloon and stent work well,117,Key Messages,“Fully deployable. Completely retrievable.”Ease in deliveryAccuracy and deployment controlOptimal coil mass supportElectrolytic detachment,118,Sales Tools,Available Q1:BrochureCompetitive overviewIn-service presentationCase study bookletWebsiteTargeted in Q2:Wall chartCD with video on preparation, deployment and detachmentSales ContestBooth graphics,119,Brochure, page 1,120,Brochure, page 2,121,122,123,Revenue objectives,124,Objectives 2009,Increase awareness / drive adoption:PublicationsKOL managementUser meetingsPodium presenceMarketing materialsSales trainingStart Registry,125,KOL,KOLs for Solitaire AB:Dr. BattacharyaDr. BoccardiProf. HenkesProf. KlischDr. LiebigProf. TurjmanKOL and User meetingsLINNC MayESMINTSeptemberPodium presentations:Val dIsereLINNCWFITNESMINTICS,126,UK Case Study,Back