SOLITAIRE颅内支架介入治疗.ppt

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 SolitaireAB 闭环 LeoPlus 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SolitaireAB 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 stentrestenosis 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 SolitaireAB产品信息 21 NotapprovedforsaleintheUnitedStates InternalUseonly Forev3Inc PresentationUseOnly NotforDistribution 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 InternalUseonly Forev3Inc PresentationUseOnly NotforDistribution 22 SolitaireAB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SolitaireAB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 4mm 27 支架重叠的中点正对支架近端标记 28 Solitaire AB支架重叠 6mm 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 CellA 0 65 CellB CellC A B 30 支架网眼重叠试验 2nd释放 A C B 0 72 1 10 0 95 CellA 0 34 0 82 0 91 1 15 1 44 1 77 CellB CellC 31 支架网眼重叠试验 3rd释放 A B C 0 43 0 97 0 97 CellA 0 32 0 61 0 69 CellB 1 77 1 90 2 62 CellC 32 解脱 SolitaireAB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 SolitaireAB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 Product SolitaireAB Solitaire 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theSOLITAIRE 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 CR00049Rev B NotavailableforsaleintheUnitedStates 解脱原理 Covidien March20 2020 Confidential 44 InsertionNeedle 钢针 SolitaireABDetachmentZone 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SolitaireAB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1mA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 CR00049Rev B NotavailableforsaleintheUnitedStates ThisispictureofNDS 1 46 配件 连接线 1副消毒针 20Gor22G CR00049Rev B NotavailableforsaleintheUnitedStates 47 DetachmentZone DetachmentZone PushWire IntroducerSheath TotalLength UsableLength DistalMarkers ProximalMarker InternalUseonly Forev3Inc PresentationUseOnly NotforDistribution 47 ElectrolyticDetachment CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 50 解脱 按 Start 开始解脱电压框显示解脱电压 0 0to9 9volts 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 Product SolitaireAB Solitaire AB exe CR00049Rev B NotavailableforsaleintheUnitedStates 操作动画 Product SolitaireAB Solitaire AB exe 51 52 成功的支架释放 DetachedStent CR00049Rev B NotavailableforsaleintheUnitedStates 53 SOLITAIRE AB的输送与输送弹簧圈一样简便 最小使用ID0 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 Distalmarkers Proximalmarker 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 March20 2020 Confidential 55 异议处理 CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 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 CR00049Rev B NotavailableforsaleintheUnitedStates 中断解脱 CR00049Rev B NotavailableforsaleintheUnitedStates 65 中断解脱并继续解脱 按 STOP 可以中断 timer 停止计时电流 0 0mA 和电压 被切断 重新开始请短按 1秒 START 电流和电压重新显示 timer 继续计时 CR00049Rev B NotavailableforsaleintheUnitedStates 66 线路连接导致的解脱中断 如果患者方的连接中断 解脱盒可以识别并长报警及 Detach 灯亮 检查线路 确保正确连接 按STOP timer 数值将归0 按START重新开始 CR00049Rev B NotavailableforsaleintheUnitedStates 67 重置Timer 重新解脱 timer重新显示 0 0 并重新计时 可以长按START重置所有参数Timer归 00 00 常规步骤解脱 CR00049Rev B NotavailableforsaleintheUnitedStates StentingTechniques 69 SingleStent Useofasinglestent Placestent detach placecoilsthruthestrutsPlacestent placecoilsthruthestruts detachPlacecatheter placestentsocatheteris jailed alongthestent placecoilsPlacethestent detach letitendothelializeforafewdays gobackinandcoilthruthestrutsUsageofstentasatemporaryassist reinforcestheadvantageofdeploymentandretrieval forcasesthatarenotamendabletoballoonsandwherethephysiciandoesn twanttoleaveinastentpermanently 70 Multiplestents StentinStenttechnique SeveralstentsmightbeneededtocovertheneckareaSomephysicianswillputstents ineachother tomaketheirown flowdiversion productX orY stenting Asecondstentisbroughtinthroughthefirststentanddeployed KissingTechnique Thestentsaredeployednexttoeachother 71 StentingTechniques 72 StentingTechniques Fieldexperience 73 Y Stenting Onestentisputinanddeployed Asecondstentisbroughtinthroughthefirststentanddeployed 74 KissingTechniquewithStraightStentFirst Insteadofbringinginanotherstentthroughthestent thestentsaredeployednexttoeachother 75 KissingTechniquewithBranchStentFirst Inbothcases thefirststentdidnotmovewhenthesecondstentwasdeployed MedicalTherapy 77 Pre procedureElective Dailydoses starting3 4dayspriortoprocedure wanttoloadthepatientwithanti platelets Aspirin 325 1 300mgPlavix 75mgAspirin Takes2 4hourstoalterplateletfunctionReducesriskofvascularmortalityPlavix Takes2daystoalterplateletfunction Generalacceptedpractice Medicationregimestatementsarenottherecommendationofev3 78 Pre procedureEmergency Rightbeforeprocedure Aspirin 325 1300mgPlavix 300 600mgDisadvantageofgivingPlavixshortlybeforeprocedureisthatitisnotaseffectiveforplateletblockage50 ofplateletsblockedin3 4hrs Generalacceptedpractice Medicationregimestatementsarenottherecommendationofev3 79 Post procedure AfterprocedurecontinuePlavix 75mg andaspirin 325mg for30 90days Then Stopboth notverycommon orStopPlavixandcontinueaspirinat325mgor81mg babyaspirin forlife mostcommon Generalacceptedpractice Medicationregimestatementsarenottherecommendationofev3 TipsandTricks 81 TipsandTricks CoilingWhenthecatheterisjailed keepingthestentattachedduringcatheterremovalwillgiveadditionalstability Keepingthestentattacheduntiltheendoftheprocedure preservestheoptiontoretrieve repositionifthecoilsdon tsitwell Stentworksverywellforbifurcation asyoucanputastentthroughthestruts Alsonott tTheabilitytoretrieve repositiongivesincrediblepeaceofmind thisispositioningnottipandtricks 82 TipsandTricks DeliveryRebaristhepreferredmicrocatheter Thestentdeliversbestthroughit IfyougetaRebarinposition thestentwillfollow Why UseRebarwithonlyonemarker Afterputtingstentthroughthehub flushthemicrocatheterbeforebringinginthestent ShouldhavecontinuousflushgoingFormostaccuratepositioning movethestentminimumof2markerlengthsdistalpasttheAN Thiswillbeapp 4mm 83 TipsandTricks DetachmentToavoidaccidentalprematuredetachment keepdetachmentzonecoveredwiththemicrocatheteruntilyouarereadytodetach Whendetachingthestent exposedetachmentzonebyunsheathingthecatheter Keepmicrocatheter1 2mmproximaltothedetachmentzonetoavoidlongerdetachmenttimesorafalsepositive Clinical 85 ClinicalPapers ANovelSelf ExpandingFullyRetrievableIntracranialStent SOLO ExperienceinNineProceduresofStent assistedAneurysmCoilOcclusion ThomasLiebig HansHenkes J rgReinartz ElinaMiloslavski andDietmarK hne Neuroradiology2006 48 471 478Immediateandmidtermfollow upresultsofusinganelectrodetachable fullyretrievableSOLOstentsystemintheendovascularcoilocclusionofwide neckedcerbralaneurysms KivilcimYavuz M D SerdarGeyik M D AlmilaGulsunPamuk M D OsmanKoc M D IsilSaatci M D andH SaruhanCekirge M D JNeurosurg107 1 7 2007 竞争产品 优点 网眼大Ystent技术操作简单可回收可应用于更广泛的血管直径支架重叠 类似 FD 效果 网眼大弹簧圈调出 范围3mm 87 88 产品信息纵览 89 StentImages Solitaire Neuroform WingspanaresameBUTWingspanhashigherradialforce LeoPlus Enterprise 90 RadialForce 91 RadialForce Physicianswouldliketoseecomparisondata thenumbersdon treallytellthemanythingClinicalimportance MeasureformigrationandstabilityAhigherradialforcesignalsthatstentmightgrabthevesselwallbetteranddoesn tmigrateComparison Enterprise SolitaireandWingspanhavealmostsameradialforce soSolitaireisok 92 Metaltovesselratio 93 Conformability 94 Conformability Physiciansdon tcommonlyaskforthisdata EnterpriseisconsideredgoodComparison EnterpriseisfineandSolitaireissignificantlybetter 95 WallApposition Solitaire Enterprise Leo Neuroform Stentsdeployedin3mmvessel 2 4mmbendradius 96 WallApposition Solitaire Enterprise Leo Neuroform Stentsdeployedin4mmvessel 2 4mmbendradius 97 WallApposition Importantdataforthephysicians Clinicalimportance Cellsofstentsthatdon thaveagoodwallapposition can texpandthatwellandthiscanhaveaneffectongettingthecatheterthru willhavetojailthecatheterPotentialofcoilherniationComparison SolitaireABmaintainsbetterwallappositionthanEnterpriseandNeuroform 98 Gator Backing Neuroform33 5x20 Leo3 5x25 SolitaireAB4x20 Enterprise4 5x22 Wingspan3 5x15 99 Kinking SolitaireAB4x20 Enterprise4 5x22 Leo3 5x25 Neuroform33 5x20 Wingspan3 5x15 100 Gator BackingandKinking Forsomephysiciansthisisimportant forothersitis nice to know thoughwouldn tstopthemfromusingastenttheylike Clinicalrelevance MayresultincoilherniationUnlikelythatkinkingwillresultinvesselocclusion thoughitmightlimitcatheteraccessComparison Gator backingandkinkingnotobservedinSolitaireABandEnterprise 101 StentCellArea 102 StentCellSize 103 Cellareaandsize PhysicianswouldliketoknowbothdataClinicalrelevance WanttoknowwholeareaforpotentialcoilherniationThesizeisimportantforcathetersizetobeabletogothruComparison Abletoplacea3mmstentthroughSolitaireABforbifurcation Y stenting whileotherstentshavemuchsmallercellsizeAcatheterdiameterof3mmcancrossSolitaire whileacatheterdiameterof1 3mmcancrosstheEnterprise ThelargestcatheterthatcanpassthroughinSolitaireis8F Thisislargerthanmostdevicesusedinneurovascularintervention SolitaireABcelllengthissimilartoEnterprise thoughSolitaireistwiceaswide thereforecellareaofSolitaireistwiceaslarge 104 Workingareaforeshortening WorkingareaofSolitaireABdoesnotforeshorten 105 Deliverymethod SolitaireAB Deviceattachedtopushwire loadedintoasheath Pushedthroughentirecatheter Electrolyticdetachment Enterprise Deviceisloadedintoasheath loadedovertheguidewireandpushedthroughtheentirecatheter Deviceisreleasedfromtheguidewirewhenreleasedfromthecatheter NeuroformandWingspan Deviceloadedoverpolymertubeandpreloadedattipofcatheter Guidewireaccessthroughpolymertube Deviceisreleasedwhencatheterispulledback Leo Devicehookedontopushwire loadedintoasheath Pushedthroughentirecatheter Devicedetacheswhenpushwiretipexitscatheterandunhooksfromdevice 106 Deliverymethod Clinicalrelevance SolitaireABiseasytouse deliverslikeacoil noextrastepsneeded Disadvantageispotentiallossofguidewireaccess StentneedstobeabletobedeliveredattherightplaceComparison Physicianswillchoosestentsbasedonaneurysmsizeandlocation stentanddeliverycharacteristics ItisimportanttounderstandofyourphysicianwhathetakesintoconfigurationandhowSolitairewillworkinhispractice MarketOverview 108 ProjectedMarketsize 109 EstimatedMarketOverview 110 OutlookSolitaireAB Potentialrisks ProductavailabilityFullrangeofsizesFlowDiversion StentsandBalloons 112 Stents AdvantagesStraightforwardandeasyprocedureSmallriskofcoilherniationChoicebetweencoilingthruthestrutsorjailingthecatheter CanputstentinafewdaysbeforecoilingandletitendothelializeIfalooppopsout youonlyhavetopulloutthatspecificcoil 113 Stents DisadvantagesPermanentforeignbodyinthebrain nolong termresultsavailableyetNeedlife timemedicationtominimizein stentrestenosisorthrombosisStentcanjumpDifficultydeployingthestentintortuousenvironmentSeveralstentsmightbenecessarytocovertheneck stentinstenttechnique Safety Riskofcatheterstuckinstent 114 Balloons AdvantagesPreventsmisplacementofcoilsandreducesriskofischemiceventsAfterprocedurenoforeignmaterialremainsinvesselSafety NoneedtoplacecatheterdeepinANforcoildeliveryIncaseofrupture aplacedballoonallowsforimmediatehemorrhagecontrolAllowscoverageofcomplexanddifficultlocatedwideneckaneurysmsUsuallynomedsneeded eventhoughsomephysiciansprefertogivePlavixand oraspirin 115 BalloonsAssistedCoiling HyperGlide HyperForm DisadvantagesNopermanentbarrierProcedureincreasesincomplexityanddurationTrainingrequiredNeedtocontroltheinflationanddeflationInstability ballooncanjumpBloodcanre entertheAN increasingthepressureandleadingtopotentialANrupturingCanonlyseeafterballoonhasbeenremovedandallcoilsdelivered ifalooppopsout Ifsoallcoilswillhavetobepulledout 116 StrategicImplications It snot necessarily aneither orstoryStentorBallooncanbeusedinmostcasesEngagethediscussionwithyourphysician HighlightbenefitsofbothandhowtheycanworkcomplementaryACOMM rarelytreatedw oballoonPCOMM balloonandstentworkwell 117 KeyMessages Fullydeployable Completelyretrievable EaseindeliveryAccuracyanddeploymentcontrolOptimalcoilmasssupportElectrolyticdetachment 118 SalesTools AvailableQ1 BrochureCompetitiveoverviewIn servicepresenta