SOLITAIRE顱內(nèi)支架介入治療參考課件

1、75646 (A) DEC/07“Confidential, For Internal ev3, Inc. Use Only, Do Not Distribute”“Not approved for sale in the United States” 75646 (A) DEC/07“Confidential,顱內(nèi)支架概覽顱內(nèi)支架概覽顱內(nèi)支架分類33顱內(nèi)支架分類33顱內(nèi)輔助支架的作用問題：寬的瘤頸使得動脈瘤內(nèi)的彈簧圈容易移位或部分脫出到載瘤動脈里，這可能造成嚴重的并發(fā)癥。解決方案：顱內(nèi)輔助支架主要用于輔助寬頸動脈瘤的彈簧圈栓塞，防止彈簧圈的移位或部分脫出。44顱內(nèi)輔助支架的作用問題：44支架

2、的基礎(chǔ)知識與常用術(shù)語支架的基礎(chǔ)知識與常用術(shù)語6開環(huán) vs. 閉環(huán)閉環(huán)設(shè)計開環(huán)設(shè)計“游離” 的尖端66開環(huán) vs. 閉環(huán)閉環(huán)設(shè)計開環(huán)設(shè)計“游離” 的尖端67顱內(nèi)支架不同的網(wǎng)眼設(shè)計Solitaire AB -閉環(huán)Leo Plus 閉環(huán)Neuroform 開環(huán)Enterprise 閉環(huán)未連接點77顱內(nèi)支架不同的網(wǎng)眼設(shè)計Solitaire AB -閉環(huán)L8輸送性和可回收性輸送性：支架能夠被輸送到病變部位的能力，尤其是通過遠端病變或通過迂曲的解剖結(jié)構(gòu)的能力?？苫厥招裕褐Ъ鼙会尫藕?，可以被重新收回且被重新放置到更優(yōu)位置的能力。這是一項非常重要的能力，分為完全回收和部分回收。88輸送性和可回收性輸送性：支架

3、能夠被輸送到病變部位的能力，尤柔軟性Flexibility為柔軟性，支架在閉合狀態(tài)下隨血管的彎曲而彎曲的能力。柔軟性越好，支架的通過性越佳。99柔軟性Flexibility為柔軟性，支架在閉合狀態(tài)下隨血管10順應(yīng)性Comfortability，支架在打開狀態(tài)下隨血管的彎曲而彎曲的能力。 順應(yīng)性好，有利于支架完全貼壁和保持血管的正常生理彎曲。順應(yīng)性差可能導(dǎo)致血栓的形成1010順應(yīng)性Comfortability，支架在打開狀態(tài)下隨血11支架的貼壁性支架的貼壁性：支架與血管壁貼合的能力。貼壁性不好可能導(dǎo)致血栓和支架移位的發(fā)生1111支架的貼壁性支架的貼壁性：支架與血管壁貼合的能力。11徑向支撐力是支

4、架對血管壁的支撐能力-決定支架對彈簧圈的支撐能力-衡量支架的穩(wěn)定性和移位效應(yīng)1212徑向支撐力是支架對血管壁的支撐能力121213開環(huán) vs. 閉環(huán)開環(huán)閉環(huán)Solitaire AB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)象明顯光滑光滑支架的結(jié)構(gòu)性支撐好更好最優(yōu)1313開環(huán) vs. 閉環(huán)開環(huán)閉環(huán)Solitaire AB徑向支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，網(wǎng)絲向外擴張/伸出的趨勢。類似鱷魚背脊。打折現(xiàn)象：支架的彎曲能力，彎曲能力差支架容易在彎曲處發(fā)生打折現(xiàn)象，容易造成血管的閉塞1414毛刺現(xiàn)象和打折現(xiàn)象毛刺現(xiàn)象：Gator

5、-Backing，15支架短縮？支架釋放/撐開前后軸向上長度的差異所有支架都有一定程度的短縮取決于支架的材質(zhì)和設(shè)計對支架的精確釋放有重要的意義，但.如果支架可以完全回收重新放置， 4 mm 4 mm4040操作圖示支架到位和釋放保持支架位置不動，小心回撤微導(dǎo)管41操作圖示支架的回收和重新釋放支架回收：保持支架位置不動，小心推送微導(dǎo)管，直到支架全部收到微導(dǎo)管里。SOLITAIRE AB可以完全回收2次。4141操作圖示支架的回收和重新釋放支架回收：4142操作圖示-填彈簧圈將微導(dǎo)管（遠端頭端 2.5F）通過支架網(wǎng)眼送入動脈瘤內(nèi)，填圈。4242操作圖示-填彈簧圈將微導(dǎo)管（遠端頭端 2.5F）通過解

6、脫 使用NDS-2解脫盒CR00049 Rev.BNot available for sale in the United States解脫 使用NDS-2解脫盒CR00049 Rev.BNo解脫原理 Covidien | 02 October 2022 | Confidential44 |Insertion Needle（鋼針）Solitaire AB Detachment Zone（支架解脫點）解脫點的金屬結(jié)構(gòu)在外部電流到達、然后離開的過程中發(fā)生電解腐蝕。如Solitaire AB的電流途徑是：電流從解脫盒發(fā)出，到達支架解脫點；支架解脫點發(fā)生電解腐蝕；然后電流通過導(dǎo)電途徑到達鋼針。完整的電

7、流回路是解脫的必要條件)（雖然鋼針也接收到電流，但是由于有一定的保護，所以結(jié)構(gòu)上不會受到影響）促進電流運動的因素：鹽水沖洗肌肉（+）（-）44解脫原理 Covidien | 02 October45解脫盒參數(shù)電壓(9V)電流1 mA按鈕：StopStartOnTimer顯示解脫過程正消耗的時間 (分.秒).最長解脫時間: 2分鐘CR00049 Rev.BNot available for sale in the United StatesThis is picture of NDS-14545解脫盒參數(shù)電壓(9V)CR00049 Rev.BNot 46配件連接線: -1副消毒針(20 G or

8、 22 G)CR00049 Rev.BNot available for sale in the United States4646配件連接線: CR00049 Rev.BNot avai47Detachment ZoneDetachment ZonePushWireIntroducerSheathTotal LengthUsable LengthDistal MarkersProximal MarkerInternal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution47 Electrolytic Detachme

9、ntCR00049 Rev.BNot available for sale in the United States4747Detachment ZoneDetachment Zo48準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, 聽到一短提示音檢測：按 Stop鈕，所有數(shù)字顯示 8.CR00049 Rev.BNot available for sale in the United States4848準備和檢測使用新電池:CR00049 Rev.BNot 49患者與器械的連接患者將消毒針插在肩膀(或腹股溝處)將

10、“黑線”卡在鋼針上。Solitaire將“紅線”卡在支架推送導(dǎo)絲的近端無PTFE涂層處暴露解脫點（確保微導(dǎo)管未覆蓋支架解脫點）。CR00049 Rev.BNot available for sale in the United States4949患者與器械的連接患者CR00049 Rev.BNot a50解脫按“Start”開始解脫電壓框顯示解脫電壓(0.0 to 9.9 volts).如果電壓顯示0.0 伏, 可能有短路存在，請重新檢查連接如解脫成功，則：解脫盒發(fā)出周期性重復(fù)的報警聲“Detach” 燈常亮或解脫2分鐘后，解脫盒發(fā)出周期性重復(fù)的報警聲.ProductSolitaire AB

11、Solitaire_AB.exeCR00049 Rev.BNot available for sale in the United States5050解脫按“Start”開始解脫CR00049 Rev.BN操作動畫.ProductSolitaire ABSolitaire_AB.exe5151操作動畫.Product52成功的支架釋放Detached StentCR00049 Rev.BNot available for sale in the United States5252成功的支架釋放Detached StentCR0004953SOLITAIRE AB的輸送與輸送彈簧圈一樣簡便，最

12、小使用ID 0.021”的微導(dǎo)管輸送。柔軟性好，易于通過迂曲的血管。使用簡便支架應(yīng)用5353SOLITAIRE AB的輸送與輸送彈簧圈一樣簡便，最54支架應(yīng)用Distal markersProximal marker輔助支撐彈簧圈 貼壁性好 徑向支撐力好 可視性佳5454支架應(yīng)用Distal markersProximal m磁共振成像相容性 02 October 2022 | Confidential55 |55磁共振成像相容性 02 October 2022 | 異議處理CR00049 Rev.BNot available for sale in the United States異議處理

13、CR00049 Rev.BNot available57防止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）CR00049 Rev.BNot available for sale in the United States5757防止填圈過程中支架解脫CR00049 Rev.BNot 58防止填圈過程中支架解脫如希望在填圈后解脫支架，則手術(shù)過程中可以:用微導(dǎo)管覆蓋支架解脫點在解脫彈簧圈時，用干布覆蓋推送導(dǎo)絲近端（體外）如果導(dǎo)絲交叉可能出現(xiàn)交叉電流，導(dǎo)致支架過早解脫。避免推送導(dǎo)絲交叉干布覆蓋支架推送導(dǎo)絲CR00049 Rev.BNot available for sale in the

14、United States5858防止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59假陽性解脫（未解脫）解脫盒已經(jīng)報警顯示解脫，但實際上未解脫CR00049 Rev.BNot available for sale in the United States5959假陽性解脫（未解脫）解脫盒已經(jīng)報警顯示解脫，但實際上未解解脫的優(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。6060解脫的優(yōu)化方法：解脫前：6060優(yōu)化方法：解脫中：確保微導(dǎo)管中持續(xù)快速滴注生理鹽水避免消毒針插在脂肪層支架近端標記與微導(dǎo)管遠端標記之間距離2

15、mm支架推送導(dǎo)絲近端在干燥的操作臺表面確保卸掉微導(dǎo)管與支架推送導(dǎo)絲上的力量6161優(yōu)化方法：解脫中：6161國外醫(yī)生經(jīng)驗方法：針頭處滴幾滴生理鹽水按Stop 重置，按Start 再次解脫換用BSC的解脫器6262國外醫(yī)生經(jīng)驗方法：626263假陰性釋放（解脫了）醫(yī)生看到支架解脫但解脫盒10秒后仍未報警 (解脫盒設(shè)定程序為解脫后5秒報警）:建議等待解脫時間至2分鐘，透視下辨別CR00049 Rev.BNot available for sale in the United States6363假陰性釋放（解脫了）醫(yī)生看到支架解脫但解脫盒10秒后仍未中斷解脫CR00049 Rev.BNot ava

16、ilable for sale in the United States中斷解脫CR00049 Rev.BNot available65中斷解脫并繼續(xù)解脫按“STOP”可以中斷“timer”停止計時電流(0.0 mA) 和電壓 (“-.-”) 被切斷.重新開始請短按 ( will have to jail the catheterPotential of coil herniationComparison:Solitaire AB maintains better wall apposition than Enterprise and Neuroform9797Wall AppositionI

17、mportant dat98Gator-BackingNeuroform3 3.5x20Leo 3.5x25Solitaire AB 4x20Enterprise 4.5x22Wingspan 3.5x159898Gator-BackingNeuroform3 3.5x99KinkingSolitaire AB 4x20Enterprise 4.5x22Leo 3.5x25Neuroform3 3.5x20Wingspan 3.5x159999KinkingSolitaire AB 4x20Ente100Gator-Backing and KinkingFor some physicians

18、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 Soli

19、taire AB and Enterprise100100Gator-Backing and KinkingFo101Stent Cell Area101101Stent Cell Area101102Stent Cell Size102102Stent Cell Size102103Cell area and sizePhysicians would like to know both dataClinical relevance:Want to know whole area for potential coil herniationThe size is important for ca

20、theter 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 t

21、hat 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.103103Cell area and sizePhysician104Working area fores

22、horteningDeviceSize (mm)Foreshortening (%)Enterprise4.5 x 156.74. 5 x 227.74.5 x 289.84.5 x 3710.9Neuroform 34 x 205.4Solitaire AB4 x 2015.36 x 3018.1Working area of Solitaire AB does not foreshorten104104Working area foreshortening105Delivery methodSolitaire AB:Device attached to pushwire, loaded i

23、nto 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 t

24、ube 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.105105Delivery

25、methodSolitaire AB106Delivery methodClinical 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

26、 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.106106Delivery methodClinical relMarket OverviewMarket Overview108Projected Market size108108Projected Market size108109Esti

27、mated Market Overview109109Estimated Market Overview10110Outlook Solitaire ABPotential risks: Product availability Full range of sizes Flow Diversion110110Outlook Solitaire ABPotentiStents and BalloonsStents and Balloons112StentsAdvantagesStraight forward and easy procedureSmall risk of coil herniat

28、ionChoice 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 coil112112StentsAdvantages112113StentsDisadvantagesPermanent foreign body in the brain, no long-term resul

29、ts 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 stent113113StentsDisadvantages1131

30、14BalloonsAdvantagesPrevents 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 compl

31、ex and difficult located wide neck aneurysmsUsually no meds needed (even though some physicians prefer to give Plavix and / or aspirin)114114BalloonsAdvantages114115Balloons Assisted Coiling HyperGlide/HyperFormDisadvantagesNo permanent barrierProcedure increases in complexity and durationTraining r

32、equiredNeed 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.1

33、15115Balloons Assisted Coiling 116Strategic ImplicationsIts 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

34、stent work well 116116Strategic ImplicationsIts 117Key Messages“Fully deployable. Completely retrievable.”Ease in deliveryAccuracy and deployment controlOptimal coil mass supportElectrolytic detachment117117Key Messages“Fully deployab118Sales ToolsAvailable Q1:BrochureCompetitive overviewIn-service

35、presentationCase study bookletWebsiteTargeted in Q2:Wall chartCD with video on preparation, deployment and detachmentSales ContestBooth graphics118118Sales ToolsAvailable Q1:118119Brochure, page 1119119Brochure, page 1119120Brochure, page 2120120Brochure, page 2120121121121121122122122122123Revenue

36、objectives2008Revenue Units ASPAccounts2008 Fcst (Rev)Market share(Units)Europe$1,402,315424$3,30776117%9.5 %IDM$420,427270$1,55721138%5.2 %Total$1,822,742694$2,62697121%7.2 %2009Revenue (AOP)Units ASPMarket share(Units)Europe$3,094,000941$3,288 18 %IDM$1,152,000752$1,53211.3 %Total$4,246,0001,693$2

37、,50814 %123123Revenue objectives2008Reven124Objectives 2009Increase awareness / drive adoption:PublicationsKOL managementUser meetingsPodium presenceMarketing materialsSales trainingStart Registry124124Objectives 2009Increase awa125KOLKOLs for Solitaire AB:Dr. BattacharyaDr. BoccardiProf. HenkesProf. KlischDr. LiebigProf. TurjmanKOL and User meetingsLINNC MayESMINTSeptemberPodium presentations:Val dIsereLINNCWFITNESMINTICS125125KOLKOLs for Solitaire AB:12126UK Case StudyBackground:Stent market was not very well developedBad experience with Neuroform and LeoEnterpr