SOLITAIRE顱內(nèi)支架介入治療

75646(A)DEC/07“Confidential,ForInternalev3,Inc.UseOnly,DoNotDistribute”“NotapprovedforsaleintheUnitedStates”

SOLITAIRE顱內(nèi)支架介入治療第1頁顱內(nèi)支架概覽SOLITAIRE顱內(nèi)支架介入治療第2頁顱內(nèi)支架分類3SOLITAIRE顱內(nèi)支架介入治療第3頁顱內(nèi)輔助支架作用問題：寬瘤頸使得動(dòng)脈瘤內(nèi)彈簧圈輕易移位或部分脫出到載瘤動(dòng)脈里，這可能造成嚴(yán)重并發(fā)癥。處理方案：顱內(nèi)輔助支架主要用于輔助寬頸動(dòng)脈瘤彈簧圈栓塞，預(yù)防彈簧圈移位或部分脫出。4SOLITAIRE顱內(nèi)支架介入治療第4頁支架基礎(chǔ)知識與慣用術(shù)語SOLITAIRE顱內(nèi)支架介入治療第5頁6開環(huán)vs.閉環(huán)閉環(huán)設(shè)計(jì)開環(huán)設(shè)計(jì)“游離”尖端SOLITAIRE顱內(nèi)支架介入治療第6頁7顱內(nèi)支架不一樣網(wǎng)眼設(shè)計(jì)SolitaireAB-閉環(huán)LeoPlus–閉環(huán)Neuroform–開環(huán)Enterprise–閉環(huán)未連接點(diǎn)SOLITAIRE顱內(nèi)支架介入治療第7頁8輸送性和可回收性輸送性：支架能夠被輸送到病變部位能力，尤其是經(jīng)過遠(yuǎn)端病變或經(jīng)過迂曲解剖結(jié)構(gòu)能力?？苫厥招裕褐Ъ鼙会尫藕?，能夠被重新收回且被重新放置到更優(yōu)位置能力。這是一項(xiàng)非常主要能力，分為完全回收和部分回收。SOLITAIRE顱內(nèi)支架介入治療第8頁柔軟性Flexibility為柔軟性，支架在閉合狀態(tài)下隨血管彎曲而彎曲能力。柔軟性越好，支架經(jīng)過性越佳。9SOLITAIRE顱內(nèi)支架介入治療第9頁10順應(yīng)性Comfortability，支架在打開狀態(tài)下隨血管彎曲而彎曲能力。順應(yīng)性好，有利于支架完全貼壁和保持血管正常生理彎曲。順應(yīng)性差可能造成血栓形成SOLITAIRE顱內(nèi)支架介入治療第10頁11支架貼壁性支架貼壁性：支架與血管壁貼合能力。貼壁性不好可能造成血栓和支架移位發(fā)生SOLITAIRE顱內(nèi)支架介入治療第11頁徑向支撐力是支架對血管壁支撐能力-決定支架對彈簧圈支撐能力-衡量支架穩(wěn)定性和移位效應(yīng)12SOLITAIRE顱內(nèi)支架介入治療第12頁13開環(huán)vs.閉環(huán)開環(huán)閉環(huán)SolitaireAB徑向支撐力中/低高高柔軟性/順應(yīng)性高低高打折和毛刺現(xiàn)象毛刺現(xiàn)象顯著光滑光滑支架結(jié)構(gòu)性支撐好愈加好最優(yōu)SOLITAIRE顱內(nèi)支架介入治療第13頁14毛刺現(xiàn)象和打折現(xiàn)象毛刺現(xiàn)象：Gator-Backing，指支架被置于彎曲解剖處時(shí)，網(wǎng)絲向外擴(kuò)張/伸出趨勢。類似鱷魚背脊。打折現(xiàn)象：支架彎曲能力，彎曲能力差支架輕易在彎曲處發(fā)生打折現(xiàn)象，輕易造成血管閉塞SOLITAIRE顱內(nèi)支架介入治療第14頁15支架短縮？支架釋放/撐開前后軸向上長度差異全部支架都有一定程度短縮取決于支架材質(zhì)和設(shè)計(jì)對支架準(zhǔn)確釋放有主要意義，但.假如支架能夠完全回收重新放置，<20%短縮率是能夠接收(如SolitaireAB)假如支架不能回收和重新放置，就需要有更低短縮率SOLITAIRE顱內(nèi)支架介入治療第15頁16金屬/血管比？在覆蓋支架血管部位，支架金屬表面積/血管表面積該指標(biāo)當(dāng)前尚不能用于反應(yīng)顱內(nèi)支架性能低金屬/血管比可能降低管壁不良反應(yīng)。SOLITAIRE顱內(nèi)支架介入治療第16頁17潛在并發(fā)癥1支架內(nèi)再狹窄（In-stentrestenosis）:

狹窄是血管腔變窄或阻塞。當(dāng)支架植入血管后，血管壁內(nèi)皮被損傷，機(jī)體對損傷進(jìn)行一系列主動(dòng)修復(fù)。即使此種修復(fù)是必要，但在一些情況下，這種修復(fù)可能過分過分修復(fù)可能造成疤痕組織在支架內(nèi)聚集，造成血管腔狹窄或阻塞，這稱為“支架內(nèi)再狹窄”?？赡茉斐赡X缺血性損傷。SOLITAIRE顱內(nèi)支架介入治療第17頁18潛在并發(fā)癥2血栓（thrombosis）:支架植入后，可能造成血栓形成。-急性、亞急性-遲發(fā)型可能造成腦缺血性卒中。SOLITAIRE顱內(nèi)支架介入治療第18頁19潛在并發(fā)癥3支架移位邊支閉塞其它..SOLITAIRE顱內(nèi)支架介入治療第19頁SolitaireAB產(chǎn)品信息SOLITAIRE顱內(nèi)支架介入治療第20頁21*NotapprovedforsaleintheUnitedStates.

"InternalUseonly"Forev3Inc.PresentationUseOnly–NotforDistribution21SOLITAIRE顱內(nèi)支架介入治療第21頁22產(chǎn)品結(jié)構(gòu)圖解脫點(diǎn)推送導(dǎo)絲導(dǎo)入鞘全長有用長度遠(yuǎn)端標(biāo)識近端標(biāo)識"InternalUseonly"Forev3Inc.PresentationUseOnly–NotforDistribution22

SOLITAIRE顱內(nèi)支架介入治療第22頁SolitaireAB產(chǎn)品特點(diǎn)23SOLITAIRE顱內(nèi)支架介入治療第23頁24輸送推送導(dǎo)絲:0.016”推送導(dǎo)絲，同彈簧圈推送一樣簡便微導(dǎo)管4mm支架使用0.021”Rebar6mm支架使用0.027”Rebar輸送和釋放可一人操作可用于遠(yuǎn)端和迂曲血管SOLITAIRE顱內(nèi)支架介入治療第24頁25產(chǎn)品型號最少確保支架釋放后能夠覆蓋瘤頸兩端各4mm距離，即有用長度最少超出瘤頸寬度8mm型號適用血管直徑直徑有用長度全長最小微導(dǎo)管內(nèi)徑遠(yuǎn)端標(biāo)識近端標(biāo)識SAB-4-153.0–4.0mm4mm15mm26mm0.021in.31SAB-4-203.0–4.0mm4mm20mm31mm0.021in.31SAB-6-205.0–6.0mm6mm20mm31mm0.027in.41SAB-6-305.0–6.0mm6mm30mm42mm0.027in.41SOLITAIRE顱內(nèi)支架介入治療第25頁26支架短縮Device鞘內(nèi)長度(mm)釋放后長度(mm)短縮率(%)4mmx20mm37.832.0(@4mm)15.36mmx30mm52.242.7(@6mm)18.1

短縮主要發(fā)生在尺寸較大血管里SolitaireAB短縮主要發(fā)生在近端

有用長度不發(fā)生短縮

回收區(qū)是發(fā)生短縮主要位置，釋放后

先確保支架遠(yuǎn)端準(zhǔn)確覆蓋了動(dòng)脈瘤遠(yuǎn)端4mm，釋放，瘤頸近端也能夠到達(dá)4mm覆蓋。SOLITAIRE顱內(nèi)支架介入治療第26頁Solitaire?AB支架重合-4mm27支架重合中點(diǎn)正對支架近端標(biāo)識.SOLITAIRE顱內(nèi)支架介入治療第27頁28Solitaire?AB支架重合-6mmSOLITAIRE顱內(nèi)支架介入治療第28頁29支架網(wǎng)眼重合試驗(yàn)—1st釋放C0.991.691.340.250.671.450.95CellA0.65CellBCellCABSOLITAIRE顱內(nèi)支架介入治療第29頁30支架網(wǎng)眼重合試驗(yàn)—2nd釋放ACB0.721.100.95CellA0.340.820.911.151.441.77CellBCellCSOLITAIRE顱內(nèi)支架介入治療第30頁31支架網(wǎng)眼重合試驗(yàn)—3rd釋放ABC0.430.970.97CellA0.320.610.69CellB1.771.902.62CellCSOLITAIRE顱內(nèi)支架介入治療第31頁32解脫SolitaireAB使用NDS-2解脫盒電解脫.解脫時(shí):輕微回撤微導(dǎo)管，暴露解脫點(diǎn)保持微導(dǎo)管在解脫點(diǎn)近端1-2mm處能夠在填圈前或后解脫SOLITAIRE顱內(nèi)支架介入治療第32頁支架操作過程SOLITAIRE顱內(nèi)支架介入治療第33頁34器械尺寸選擇依據(jù)病變情況參考說明書選擇SOLITAIRE?AB及微導(dǎo)管:SolitaireAB與Rebar配合使用

支架尺寸1）直徑：參考目標(biāo)血管節(jié)段近端、遠(yuǎn)端較大直徑尺寸2）長度：需要確保其有用長度能夠覆蓋動(dòng)脈瘤頸兩端各4mm距離。SOLITAIRE顱內(nèi)支架介入治療第34頁操作動(dòng)畫（可替換操作圖示）..\..\..\..\..\..\Product\SolitaireAB\Solitaire_AB.exe35SOLITAIRE顱內(nèi)支架介入治療第35頁36操作--微導(dǎo)管到位推送微導(dǎo)管到適當(dāng)位置：確保當(dāng)支架釋放后，支架兩端能夠覆蓋瘤頸兩端各4mm距離。SOLITAIRE顱內(nèi)支架介入治療第36頁37操作圖示—插入支架將導(dǎo)引鞘部分插入RHV旋緊RHV連續(xù)滴注，確認(rèn)可見液體從導(dǎo)引鞘近端流出37“Confidential,ForInternalev3,Inc.UseOnly,DoNotDistribute”“NotapprovedforsaleintheUnitedStates”

SOLITAIRE顱內(nèi)支架介入治療第37頁38操作圖示—插入支架旋松RHV推送導(dǎo)引鞘直到穩(wěn)定在微導(dǎo)管卡口處旋緊RHV輕柔向前推送theSOLITAIRE?AB進(jìn)入微導(dǎo)管38“Confidential,ForInternalev3,Inc.UseOnly,DoNotDistribute”“NotapprovedforsaleintheUnitedStates”

SOLITAIRE顱內(nèi)支架介入治療第38頁39操作圖示—支架到位和釋放當(dāng)支架推送導(dǎo)絲柔軟部分完全進(jìn)入微導(dǎo)管尾端，撤掉導(dǎo)引鞘一直推送SOLITAIRE?AB直到支架遠(yuǎn)端標(biāo)識抵達(dá)微導(dǎo)管末端，確保在支架釋放后，能夠充分覆蓋瘤頸兩端最少4mm距離。注：推送過程中如遇很大阻力請停頓推送SOLITAIRE顱內(nèi)支架介入治療第39頁40操作圖示—支架到位和釋放保持支架位置不動(dòng)，小心回撤微導(dǎo)管，釋放支架。為到達(dá)支架充分釋放，微導(dǎo)管需要撤到支架近端標(biāo)識近端。>4mm>4mmSOLITAIRE顱內(nèi)支架介入治療第40頁41操作圖示—支架回收和重新釋放支架回收：保持支架位置不動(dòng)，小心推送微導(dǎo)管，直到支架全部收到微導(dǎo)管里。SOLITAIRE?AB能夠完全回收2次。SOLITAIRE顱內(nèi)支架介入治療第41頁42操作圖示--填彈簧圈將微導(dǎo)管（遠(yuǎn)端頭端≤2.5F）經(jīng)過支架網(wǎng)眼送入動(dòng)脈瘤內(nèi)，填圈。SOLITAIRE顱內(nèi)支架介入治療第42頁解脫–使用NDS-2解脫盒CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第43頁解脫原理Covidien|24April2023|Confidential44|InsertionNeedle（鋼針）SolitaireABDetachmentZone（支架解脫點(diǎn)）解脫點(diǎn)金屬結(jié)構(gòu)在外部電流抵達(dá)、然后離開過程中發(fā)生電解腐蝕。如SolitaireAB電流路徑是：電流從解脫盒發(fā)出，抵達(dá)支架解脫點(diǎn)；支架解脫點(diǎn)發(fā)生電解腐蝕；然后電流經(jīng)過導(dǎo)電路徑抵達(dá)鋼針。完整電流回路是解脫必要條件)（即使鋼針也接收到電流，不過因?yàn)橛幸欢ūＷo(hù)，所以結(jié)構(gòu)上不會(huì)受到影響）促進(jìn)電流運(yùn)動(dòng)原因：鹽水沖洗肌肉（+）（-）SOLITAIRE顱內(nèi)支架介入治療第44頁45解脫盒參數(shù)電壓(9V)電流1mA按鈕：‘Stop’‘Start’‘On’‘Timer’顯示解脫過程正消耗時(shí)間(分.秒).最長解脫時(shí)間:2分鐘CR00049Rev.BNotavailableforsaleintheUnitedStatesThisispictureofNDS-1SOLITAIRE顱內(nèi)支架介入治療第45頁46配件連接線:-1副消毒針(20Gor22G)CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第46頁47DetachmentZoneDetachmentZonePushWireIntroducerSheathTotalLengthUsableLengthDistalMarkersProximalMarker"InternalUseonly"Forev3Inc.PresentationUseOnly–NotforDistribution47ElectrolyticDetachmentCR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第47頁48準(zhǔn)備和檢測使用新電池:電池指示燈常亮：電量足夠電池指示燈閃爍：

更換電池將連接線接頭插到解脫盒上，并旋緊確保連好。打開開關(guān)‘On’,聽到一短提醒音檢測：按‘Stop’鈕，全部數(shù)字顯示‘8’.CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第48頁49患者與器械連接患者將消毒針插在肩膀(或腹股溝處)將“黑線”卡在鋼針上。Solitaire將“紅線”卡在支架推送導(dǎo)絲近端無PTFE涂層處暴露解脫點(diǎn)（確保微導(dǎo)管未覆蓋支架解脫點(diǎn)）。CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第49頁50解脫按“Start”開始解脫電壓框顯示解脫電壓(0.0to9.9volts).假如電壓顯示0.0伏,可能有短路存在，請重新檢驗(yàn)連接如解脫成功，則：解脫盒發(fā)出周期性重復(fù)報(bào)警聲“Detach”燈常亮或解脫2分鐘后，解脫盒發(fā)出周期性重復(fù)報(bào)警聲..\..\..\..\..\..\Product\SolitaireAB\Solitaire_AB.exeCR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第50頁操作動(dòng)畫..\..\..\..\..\..\Product\SolitaireAB\Solitaire_AB.exe51SOLITAIRE顱內(nèi)支架介入治療第51頁52成功支架釋放DetachedStentCR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第52頁53SOLITAIRE?AB輸送與輸送彈簧圈一樣簡便，最小使用ID0.021”微導(dǎo)管輸送。柔軟性好，易于經(jīng)過迂曲血管。使用簡便支架應(yīng)用SOLITAIRE顱內(nèi)支架介入治療第53頁54支架應(yīng)用DistalmarkersProximalmarker輔助支撐彈簧圈

貼壁性好

徑向支撐力好

可視性佳SOLITAIRE顱內(nèi)支架介入治療第54頁磁共振成像相容性

24April2023|Confidential55|SOLITAIRE顱內(nèi)支架介入治療第55頁異議處理CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第56頁57預(yù)防填圈過程中支架解脫假陽性解脫（未解脫）假陰性解脫（解脫了）CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第57頁58預(yù)防填圈過程中支架解脫如希望在填圈后解脫支架，則手術(shù)過程中能夠:用微導(dǎo)管覆蓋支架解脫點(diǎn)在解脫彈簧圈時(shí)，用干布覆蓋推送導(dǎo)絲近端（體外）假如導(dǎo)絲交叉可能出現(xiàn)交叉電流，造成支架過早解脫。防止推送導(dǎo)絲交叉干布覆蓋支架推送導(dǎo)絲CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第58頁59假陽性解脫（未解脫）解脫盒已經(jīng)報(bào)警顯示解脫，但實(shí)際上未解脫CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第59頁解脫優(yōu)化方法：解脫前：消毒針插在患者肩膀或頸部。在針頭處滴幾滴生理鹽水。消毒針插在肌肉層里。使用9V新電池。使用新電解線。60SOLITAIRE顱內(nèi)支架介入治療第60頁優(yōu)化方法：解脫中：確保微導(dǎo)管中連續(xù)快速滴注生理鹽水防止消毒針插在脂肪層支架近端標(biāo)識與微導(dǎo)管遠(yuǎn)端標(biāo)識之間距離<2mm支架推送導(dǎo)絲近端在干燥操作臺表面確保卸掉微導(dǎo)管與支架推送導(dǎo)絲上力量61SOLITAIRE顱內(nèi)支架介入治療第61頁國外醫(yī)生經(jīng)驗(yàn)方法：針頭處滴幾滴生理鹽水按‘Stop’重置，按‘Start’再次解脫換用BSC解脫器62SOLITAIRE顱內(nèi)支架介入治療第62頁63假陰性釋放（解脫了）醫(yī)生看到支架解脫但解脫盒10秒后仍未報(bào)警

(解脫盒設(shè)定程序?yàn)榻饷摵?秒報(bào)警）:提議等候解脫時(shí)間至2分鐘，透視下區(qū)分CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第63頁中止解脫CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第64頁65中止解脫并繼續(xù)解脫按“STOP”能夠中止“timer”停頓計(jì)時(shí)電流(0.0mA)和電壓(“-.-”)被切斷.重新開始請短按(<1秒)“START”.電流和電壓重新顯示，“timer”繼續(xù)計(jì)時(shí)CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第65頁66線路連接造成解脫中止假如患者方連接中止,解脫盒能夠識別并長報(bào)警及“Detach”燈亮。

檢驗(yàn)線路，確保正確連接。按STOP，“timer”數(shù)值將歸0。按START重新開始。CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第66頁67重置Timer重新解脫（timer重新顯示“0.0”并重新計(jì)時(shí)）能夠長按START重置全部參數(shù)Timer歸"00.00".常規(guī)步驟解脫。CR00049Rev.BNotavailableforsaleintheUnitedStatesSOLITAIRE顱內(nèi)支架介入治療第67頁StentingTechniquesSOLITAIRE顱內(nèi)支架介入治療第68頁69SingleStentUseofasinglestent:Placestent,detach,placecoilsthruthestrutsPlacestent,placecoilsthruthestruts,detachPlacecatheter,placestentsocatheteris‘jailed’alongthestent,placecoilsPlacethestent,detach,letitendothelializeforafewdays,gobackinandcoilthruthestrutsUsageofstentasatemporaryassist–reinforcestheadvantageofdeploymentandretrieval–forcasesthatarenotamendabletoballoonsandwherethephysiciandoesn’twanttoleaveinastentpermanentlySOLITAIRE顱內(nèi)支架介入治療第69頁70MultiplestentsStentinStenttechnique:SeveralstentsmightbeneededtocovertheneckareaSomephysicianswillputstents‘ineachother’tomaketheirown‘flowdiversion’productX–orY-stenting:Asecondstentisbroughtinthroughthefirststentanddeployed.KissingTechnique:ThestentsaredeployednexttoeachotherSOLITAIRE顱內(nèi)支架介入治療第70頁71StentingTechniquesTechniqueWhyitisdoneWhereitisdoneProsConsSinglestentWide-neckedaneurysmfromsingleparentvesselICA,MCA,ACA,VA,BA,PCAEndovascularreconstructionofwide-neckedaneurysmsX/Y-stentingWide-neckedaneurysminvolvingtwomajorvesselsBi-furcation,i.e.,ACOMcomplex,MCA,BA,ICAbifurcationsReconstructionofcomplex,surgicallydifficultaneurysmsRisk-benefitratioversusopensurgerynotdeterminedKissingTechniqueSameindicationsasYComplexMCA,BA,ICAbifurcationsReconstructionofcomplex,surgicallydifficultaneurysmsRisk-benefitratioversusopensurgerynotdeterminedSOLITAIRE顱內(nèi)支架介入治療第71頁72StentingTechniquesTechniqueSolitaireABNeuroformEnterpriseSinglestentPossiblePossiblePossibleY-stentingAllowsa3mmdiametercircletopassthrough.*PossiblewithNeuroform2,notrecommendedwithNeuroform3Notpossible.Only1.5mmdiametertoremainopen,whichisnotbigenough.KissingTechniquePossible*PossiblePossible*FieldexperienceSOLITAIRE顱內(nèi)支架介入治療第72頁73Y-StentingOnestentisputinanddeployed.Asecondstentisbroughtinthroughthefirststentanddeployed.SOLITAIRE顱內(nèi)支架介入治療第73頁74KissingTechniquewithStraightStentFirstInsteadofbringinginanotherstentthroughthestent,thestentsaredeployednexttoeachother.SOLITAIRE顱內(nèi)支架介入治療第74頁75KissingTechniquewithBranchStentFirstInbothcases,thefirststentdidnotmovewhenthesecondstentwasdeployed.SOLITAIRE顱內(nèi)支架介入治療第75頁MedicalTherapySOLITAIRE顱內(nèi)支架介入治療第76頁77Pre-procedureElectiveDailydoses,starting3-4dayspriortoprocedure,wanttoloadthepatientwithanti-platelets:Aspirin:325–1,300mgPlavix:75mgAspirin:Takes2–4hourstoalterplateletfunctionReducesriskofvascularmortalityPlavix:Takes2daystoalterplateletfunction*Generalacceptedpractice,Medicationregimestatementsarenottherecommendationofev3SOLITAIRE顱內(nèi)支架介入治療第77頁78Pre-procedureEmergencyRightbeforeprocedure:Aspirin:325-1300mgPlavix:300–600mgDisadvantageofgivingPlavixshortlybeforeprocedureisthatitisnotaseffectiveforplateletblockage50%ofplateletsblockedin3-4hrs*Generalacceptedpractice,Medicationregimestatementsarenottherecommendationofev3SOLITAIRE顱內(nèi)支架介入治療第78頁79Post-procedureAfterprocedurecontinuePlavix(75mg)andaspirin(325mg)for30–90days.Then:Stopboth(notverycommon)orStopPlavixandcontinueaspirinat325mgor81mg(babyaspirin)forlife(mostcommon)*Generalacceptedpractice,Medicationregimestatementsarenottherecommendationofev3SOLITAIRE顱內(nèi)支架介入治療第79頁TipsandTricksSOLITAIRE顱內(nèi)支架介入治療第80頁81TipsandTricksCoilingWhenthecatheterisjailed,keepingthestentattachedduringcatheterremovalwillgiveadditionalstability.Keepingthestentattacheduntiltheendoftheprocedure,preservestheoptiontoretrieve/repositionifthecoilsdon’tsitwell.Stentworksverywellforbifurcation,asyoucanputastentthroughthestruts.Alsonott&tTheabilitytoretrieve/repositiongivesincrediblepeaceofmind!(thisispositioningnottipandtricks)SOLITAIRE顱內(nèi)支架介入治療第81頁82TipsandTricksDeliveryRebaristhepreferredmicrocatheter.Thestentdeliversbestthroughit.IfyougetaRebarinposition,thestentwillfollow.Why?UseRebarwithonlyonemarker…Afterputtingstentthroughthehub,flushthemicrocatheterbeforebringinginthestent.ShouldhavecontinuousflushgoingFormostaccuratepositioning,movethestentminimumof2markerlengthsdistalpasttheAN.Thiswillbeapp.4mm.SOLITAIRE顱內(nèi)支架介入治療第82頁83TipsandTricksDetachmentToavoidaccidentalprematuredetachment,keepdetachmentzonecoveredwiththemicrocatheteruntilyouarereadytodetach.Whendetachingthestent,exposedetachmentzonebyunsheathingthecatheter.Keepmicrocatheter1-2mmproximaltothedetachmentzonetoavoidlongerdetachmenttimesorafalsepositive.SOLITAIRE顱內(nèi)支架介入治療第83頁ClinicalSOLITAIRE顱內(nèi)支架介入治療第84頁85ClinicalPapersANovelSelf-ExpandingFullyRetrievableIntracranialStent(SOLO):ExperienceinNineProceduresofStent-assistedAneurysmCoilOcclusion–ThomasLiebig,HansHenkes,J?rgReinartz,ElinaMiloslavski,andDietmarKühne–Neuroradiology: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,SOLITAIRE顱內(nèi)支架介入治療第85頁競爭產(chǎn)品SOLITAIRE顱內(nèi)支架介入治療第86頁優(yōu)點(diǎn)網(wǎng)眼大Ystent技術(shù)操作簡單可回收可應(yīng)用于更廣泛血管直徑支架重合，類似“FD”效果網(wǎng)眼大彈簧圈調(diào)出，范圍3mm?87SOLITAIRE顱內(nèi)支架介入治療第87頁88產(chǎn)品信息縱覽SolitaireAB(ev3)Enterprise(Cordis)Neuroform(BSC)Wingspan(BSC)LeoPlus(Balt)IndicationIntracranialVascularDiseaseIntracranialAneurysmsIntracranialAneurysmsIntracranialAtherscleroticStenosisIntracranialAneurysmsRetrievable/RepositionableYESPARTIALLY(fulldeploymentimpossible)NONOPARTIALLY(fulldeploymentimpossible)Sizes(mm)4,64.52.5,3,3.5,4,4.52.5,3,3.5,4,4.52.5,3.5,4.5,5.5WorkingLengths(mm)15,20,3014,22,28,3710,15,20,3019,15,2012,15,18,20,25,30,35,40,50,75VesselRange3-6mm2.5-4mm2-4.5mm2-4.5mm2-5.5mmCellTypeClosedClosedOpenOpenClosedMarkers3or4distal&1proximal4markersoneachend4markersoneachend4markersoneachend2platinumthreadsonstentbodySOLITAIRE顱內(nèi)支架介入治療第88頁89StentImagesSolitaireNeuroform&WingspanaresameBUTWingspanhashigherradialforceLeoPlusEnterpriseSOLITAIRE顱內(nèi)支架介入治療第89頁90RadialForceSOLITAIRE顱內(nèi)支架介入治療第90頁91RadialForcePhysicianswouldliketoseecomparisondata,thenumbersdon’treallytellthemanythingClinicalimportance:MeasureformigrationandstabilityAhigherradialforcesignalsthatstentmightgrabthevesselwallbetteranddoesn’tmigrateComparison:Enterprise,SolitaireandWingspanhavealmostsameradialforce,soSolitaireisok.SOLITAIRE顱內(nèi)支架介入治療第91頁92MetaltovesselratioSOLITAIRE顱內(nèi)支架介入治療第92頁93ConformabilitySOLITAIRE顱內(nèi)支架介入治療第93頁94ConformabilityPhysiciansdon’tcommonlyaskforthisdata:EnterpriseisconsideredgoodComparison:EnterpriseisfineandSolitaireissignificantlybetterSOLITAIRE顱內(nèi)支架介入治療第94頁95WallAppositionSolitaireEnterpriseLeoNeuroformStentsdeployedin3mmvessel,2.4mmbendradiusSOLITAIRE顱內(nèi)支架介入治療第95頁96WallAppositionSolitaireEnterpriseLeoNeuroformStentsdeployedin4mmvessel,2.4mmbendradiusSOLITAIRE顱內(nèi)支架介入治療第96頁97WallAppositionImportantdataforthephysicians.Clinicalimportance:Cellsofstentsthatdon’thaveagoodwallapposition,can’texpandthatwellandthiscanhaveaneffectongettingthecatheterthru->willhavetojailthecatheterPotentialofcoilherniationComparison:SolitaireABmaintainsbetterwallappositionthanEnterpriseandNeuroformSOLITAIRE顱內(nèi)支架介入治療第97頁98Gator-BackingNeuroform33.5x20Leo3.5x25SolitaireAB4x20Enterprise4.5x22Wingspan3.5x15SOLITAIRE顱內(nèi)支架介入治療第98頁99KinkingSolitaireAB4x20Enterprise4.5x22Leo3.5x25Neuroform33.5x20Wingspan3.5x15SOLITAIRE顱內(nèi)支架介入治療第99頁100Gator-BackingandKinkingForsomephysiciansthisisimportant,forothersitis‘nice-to-know’thoughwouldn’tstopthemfromusingastenttheylike.Clinicalrelevance:MayresultincoilherniationUnlikelythatkinkingwillresultinvesselocclusion,thoughitmightlimitcatheteraccessComparison:Gator-backingandkinkingnotobservedinSolitaireABandEnterpriseSOLITAIRE顱內(nèi)支架介入治療第100頁101StentCellAreaSOLITAIRE顱內(nèi)支架介入治療第101頁102StentCellSizeSOLITAIRE顱內(nèi)支架介入治療第102頁103CellareaandsizePhysicianswouldliketoknowbothdataClinicalrelevance:WanttoknowwholeareaforpotentialcoilherniationThesizeisimportantforcathetersizetobeabletogothruComparison:Abletoplacea3mmstentthroughSolitaireABforbifurcation/Y-stenting,whileotherstentshavemuchsmallercellsizeAcatheterdiameterof3mmcancrossSolitaire,whileacatheterdiameterof1.3mmcancrosstheEnterprise.ThelargestcatheterthatcanpassthroughinSolitaireis8F.Thisislargerthanmostdevicesusedinneurovascularintervention.SolitaireABcelllengthissimilartoEnterprise,thoughSolitaireistwiceaswide,thereforecellareaofSolitaireistwiceaslarge.SOLITAIRE顱內(nèi)支架介入治療第103頁104WorkingareaforeshorteningDeviceSize(mm)Foreshortening(%)Enterprise4.5x156.74.5x227.74.5x289.84.5x3710.9Neuroform34x205.4SolitaireAB4x2015.36x3018.1WorkingareaofSolitaireABdoesnotforeshortenSOLITAIRE顱內(nèi)支架介入治療第104頁105DeliverymethodSolitaireAB:Deviceattachedtopushwire,loadedintoasheath.Pushedthroughentirecatheter.Electrolyticdetachment.Enterprise:Deviceisloadedintoasheath,loadedovertheguidewireandpushedthroughtheentirecatheter.Deviceisreleasedfromtheguidewirewhenreleasedfromthecatheter.NeuroformandWingspan:Deviceloadedoverpolymertubeandpreloadedattipofcatheter.Guidewireaccessthroughpolymertube.Deviceisreleasedwhencatheterispulledback.Leo:Devicehookedontopushwire,loadedintoasheath.Pushedthroughentirecatheter.Devicedetacheswhenpushwiretipexitscatheterandunhooksfromdevice.SOLITAIRE顱內(nèi)支架介入治療第105頁106DeliverymethodClinicalrelevance:SolitaireABiseasytouse,deliverslikeacoil,noextrastepsneeded.Disadvantageispotentiallossofguidewireaccess.StentneedstobeabletobedeliveredattherightplaceComparison:Physicianswillchoosestentsbasedonaneurysmsizeandlocation,stentanddeliverycharacteristics.ItisimportanttounderstandofyourphysicianwhathetakesintoconfigurationandhowSolitairewillworkinhispractice.SOLITAIRE顱內(nèi)支架介入治療第106頁MarketOverviewSOLITAIRE顱內(nèi)支架介入治療第107頁108ProjectedMarketsizeSOLITAIRE顱內(nèi)支架介入治療第108頁109EstimatedMarketOverviewSOLITAIRE顱內(nèi)支架介入治療第109頁110OutlookSolitaireABPotentialrisks:ProductavailabilityFullrangeofsizesFlowDiversionSOLITAIRE顱內(nèi)支架介入治療第110頁StentsandBalloonsSOLITAIRE顱內(nèi)支架介入治療第111頁112StentsAdvantagesStraightforwardandeasyprocedureSmallriskofcoilherniationChoicebetweencoilingthruthestrutsorjailingthecatheter.CanputstentinafewdaysbeforecoilingandletitendothelializeIfalooppopsout,youonlyhavetopulloutthatspecificcoilSOLITAIRE顱內(nèi)支架介入治療第112頁113StentsDisadvantagesPermanentforeignbodyinthebrain,nolong-termresultsavailableyetNeedlife-timemedicationtominimizein-stentrestenosisorthrombosisStentcanjumpDifficultydeployingthestentintortuousenvironmentSeveralstentsmightbenecessarytocovertheneck(stentinstenttechnique)Safety:RiskofcatheterstuckinstentSOLITAIRE顱內(nèi)支架介入治療第113頁114BalloonsAdvantagesPreventsmisplacementofcoilsandreducesriskofischemiceventsAfterprocedurenoforeignmaterialremainsinvesselSafety:NoneedtoplacecatheterdeepinANforcoildeliveryIncaseofrupture,aplacedballoonallowsforimmediatehemorrhagecontrolAllowscoverageofcomplexanddifficultlocatedwideneckaneurysmsUsuallynomedsneeded(eventhoughsomephysiciansprefertogivePlavixand/oraspirin)SOLITAIRE顱內(nèi)支架介入治療第114頁115BalloonsAssistedCoiling–HyperGlide/HyperFormDisadvantagesNopermanentbarrierProcedureincreasesincomplexityanddurationTrainingrequiredNeedtocontroltheinflationanddeflationInstability,ballooncanjumpBloodcanre-entertheAN,increasingthepressureandleadingtopotentialANrupturingCanonlyseeafterballoonhasbeenremovedandallcoilsdelivered,ifalooppopsout.Ifsoallcoilswillhavetobepulledout.SOLITAIRE顱內(nèi)支架介入治療第115頁116StrategicImplicationsIt’snot(necessarily)aneither/orstoryStentorBallooncanbeusedinmostcasesEngagethediscussionwithyourphysician!HighlightbenefitsofbothandhowtheycanworkcomplementaryACOMM:rarelytreatedw/oballoonPCOMM:balloonandstentworkwellSOLITAIRE顱內(nèi)支架介入治療第116頁117KeyMessages“Fullydeployable.Completelyretrievable.”EaseindeliveryAccuracyanddeploymentcontrolOptimalcoilmasssupportElectrolyticdetachmentSOLITAIRE顱內(nèi)支架介入治療第117頁118SalesToolsAvailableQ1:BrochureCompetitiveoverviewIn-servicepresentationCasestudybookletWebsiteTargetedinQ2:WallchartCDwith