1、顱內支架概覽第1頁/共130頁顱內支架分類2第2頁/共130頁顱內輔助支架的作用問題：寬的瘤頸使得動脈瘤內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癥。解決方案：顱內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。3第3頁/共130頁支架的基礎知識與常用術語第4頁/共130頁5開環 vs. 閉環閉環設計開環設計“游離” 的尖端第5頁/共130頁6顱內支架不同的網眼設計Solitaire AB -閉環Leo Plus 閉環Neuroform 開環Enterprise 閉環未連接點第6頁/共130頁7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

2、，尤其是通過遠端病變或通過迂曲的解剖結構的能力。 可回收性：支架被釋放后，可以被重新收回且被重新放置到更優位置的能力。這是一項非常重要的能力，分為完全回收和部分回收。第7頁/共130頁柔軟性 Flexibility為柔軟性，支架在閉合狀態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。8第8頁/共130頁9順應性 Comfortability，支架在打開狀態下隨血管的彎曲而彎曲的能力。 順應性好，有利于支架完全貼壁和保持血管的正常生理彎曲。 順應性差可能導致血栓的形成第9頁/共130頁10支架的貼壁性 支架的貼壁性：支架與血管壁貼合的能力。 貼壁性不好可能導致血栓和支架移位的發生第1

3、0頁/共130頁徑向支撐力 是支架對血管壁的支撐能力-決定支架對彈簧圈的支撐能力-衡量支架的穩定性和移位效應11第11頁/共130頁12開環 vs. 閉環開環閉環Solitaire AB徑向支撐力中/低高高柔軟性/順應性高低高打折和毛刺現象毛刺現象明顯光滑光滑支架的結構性支撐好更好最優第12頁/共130頁13毛刺現象和打折現象 毛刺現象：Gator-Backing，指支架被置于彎曲解剖處時，網絲向外擴張/伸出的趨勢。類似鱷魚背脊。 打折現象：支架的彎曲能力，彎曲能力差支架容易在彎曲處發生打折現象，容易造成血管的閉塞第13頁/共130頁14支架短縮？ 支架釋放/撐開前后軸向上長度的差異 所有支架

4、都有一定程度的短縮 取決于支架的材質和設計 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 mm第39頁/共130頁40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，小心推送微導管，直到支架全部收到微導管里。SOLITAIRE AB可以完全回收2次。第40頁/共130頁41操作圖示-填彈簧圈將微導管（遠端頭端 2.5F）通過支架網眼送入動脈瘤內，填圈。第41頁/共130頁解脫 使用NDS-2解脫盒CR00049 Rev.BNot available for sale in the United States第42頁/共130頁解脫原理 Covidie

5、n | October 23, 2021 | Confidential43 |Insertion Needle（鋼針）Solitaire AB Detachment Zone（支架解脫點） 解脫點的金屬結構在外部電流到達、然后離開的過程中發生電解腐蝕。 如Solitaire AB的電流途徑是：電流從解脫盒發出，到達支架解脫點；支架解脫點發生電解腐蝕；然后電流通過導電途徑到達鋼針。完整的電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，所以結構上不會受到影響）促進電流運動的因素：1.鹽水沖洗2.肌肉（+）（-）第43頁/共130頁44解脫盒參數 電壓(9V) 電流1 mA

6、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-1第44頁/共130頁45配件 連接線: -1副 消毒針(20 G or 22 G)CR00049 Rev.BNot available for sale in the United States第45頁/共130頁46Detachment ZoneDetachment ZonePushWireIntroducerSheathTotal L

7、engthUsable LengthDistal MarkersProximal MarkerInternal Use onlyFor ev3 Inc. Presentation Use Only Not for Distribution46 Electrolytic DetachmentCR00049 Rev.BNot available for sale in the United States第46頁/共130頁47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On, 聽到一短提示音 檢測：按 Stop

8、鈕，所有數字顯示 8.CR00049 Rev.BNot available for sale in the United States第47頁/共130頁48患者與器械的連接患者 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”卡在支架推送導絲的近端無PTFE涂層處 暴露解脫點（確保微導管未覆蓋支架解脫點）。CR00049 Rev.BNot available for sale in the United States第48頁/共130頁49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

9、路存在，請重新檢查連接如解脫成功，則：解脫盒發出周期性重復的報警聲“Detach” 燈常亮或解脫2分鐘后，解脫盒發出周期性重復的報警聲.ProductSolitaire ABSolitaire_AB.exeCR00049 Rev.BNot available for sale in the United States第49頁/共130頁操作動畫 .ProductSolitaire ABSolitaire_AB.exe50第50頁/共130頁51成功的支架釋放Detached StentCR00049 Rev.BNot available for sale in the United State

10、s第51頁/共130頁52SOLITAIRE AB的輸送與輸送彈簧圈一樣簡便，最小使用ID 0.021”的微導管輸送。柔軟性好，易于通過迂曲的血管。使用簡便支架應用第52頁/共130頁53支架應用Distal markersProximal marker輔助支撐彈簧圈 貼壁性好 徑向支撐力好 可視性佳第53頁/共130頁磁共振成像相容性 October 23, 2021 | Confidential54 |第54頁/共130頁異議處理CR00049 Rev.BNot available for sale in the United States第55頁/共130頁56 防止填圈過程中支架解脫

11、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 States第56頁/共130頁57防止填圈過程中支架解脫如希望在填圈后解脫支架，則手術過程中可以: 用微導管覆蓋支架解脫點 在解脫彈簧圈時，用干布覆蓋推送導絲近端（體外）-如果導絲交叉可能出現交叉電流，導致支架過早解脫。避免推送導絲交叉干布覆蓋支架推送導絲CR00049 Rev.BNot available for sale in the United States第57頁/共130頁58假陽性解脫（未解脫） 解脫盒已經報警顯示解脫，但實際上未解脫CR

12、00049 Rev.BNot available for sale in the United States第58頁/共130頁解脫的優化方法： 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。59第59頁/共130頁優化方法： 解脫中： 確保微導管中持續快速滴注生理鹽水 避免消毒針插在脂肪層 支架近端標記與微導管遠端標記之間距離2mm 支架推送導絲近端在干燥的操作臺表面 確保卸掉微導管與支架推送導絲上的力量60第60頁/共130頁國外醫生經驗 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

13、的解脫器61第61頁/共130頁62假陰性釋放（解脫了） 醫生看到支架解脫但解脫盒10秒后仍未報警 (解脫盒設定程序為解脫后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 States第62頁/共130頁中斷解脫CR00049 Rev.BNot available for sale in the United States第63頁/共130頁64中斷解脫并繼續解脫 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 ( wil

14、l have to jail the catheter Potential of coil herniation Comparison: Solitaire AB maintains better wall apposition than Enterprise and Neuroform第96頁/共130頁97Gator-BackingNeuroform3 3.5x20Leo 3.5x25Solitaire AB 4x20Enterprise 4.5x22Wingspan 3.5x15第97頁/共130頁98KinkingSolitaire AB 4x20Enterprise 4.5x22Le

15、o 3.5x25Neuroform3 3.5x20Wingspan 3.5x15第98頁/共130頁99Gator-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 occl

16、usion, though it might limit catheter access Comparison: Gator-backing and kinking not observed in Solitaire AB and Enterprise第99頁/共130頁100Stent Cell Area第100頁/共130頁101Stent Cell Size第101頁/共130頁102Cell area and size Physicians would like to know both data Clinical relevance: Want to know whole area

17、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 diame

18、ter 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

19、as large.第102頁/共130頁103Working area foreshorteningDeviceSize (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 foreshorten第103頁/共130頁104Delivery method Solitaire AB: Device attached

20、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: Dev

21、ice 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

22、from device.第104頁/共130頁105Delivery 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 ane

23、urysm 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.第105頁/共130頁Market Overview第106頁/共130頁107Projected Market size第107頁/共130頁108Estimated Market Overview第108頁/共130頁109

24、Outlook Solitaire ABPotential risks: Product availability Full range of sizes Flow Diversion第109頁/共130頁Stents and Balloons第110頁/共130頁111StentsAdvantages Straight forward and easy procedure Small risk of coil herniation Choice between coiling thru the struts or jailing the catheter. Can put stent in

25、a few days before coiling and let it endothelialize If a loop pops out, you only have to pull out that specific coil第111頁/共130頁112StentsDisadvantages Permanent foreign body in the brain, no long-term results available yet Need life-time medication to minimize in-stent restenosis or thrombosis Stent

26、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第112頁/共130頁113BalloonsAdvantages Prevents misplacement of coils and reduces risk of ischemic events After procedure no

27、 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 pre

28、fer to give Plavix and / or aspirin)第113頁/共130頁114Balloons Assisted Coiling HyperGlide/HyperFormDisadvantages 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, inc

29、reasing 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.第114頁/共130頁115Strategic Implications Its not (necessarily) an either / or story Stent or Balloon can be used

30、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 第115頁/共130頁116Key Messages “Fully deployable. Completely retrievable.” Ease in delivery Accuracy and deploym

31、ent control Optimal coil mass support Electrolytic detachment第116頁/共130頁117Sales 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第117頁/共

32、130頁118Brochure, page 1第118頁/共130頁119Brochure, page 2第119頁/共130頁120第120頁/共130頁121第121頁/共130頁122Revenue 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

33、 ASPMarket share(Units)Europe$3,094,000941$3,288 18 %IDM$1,152,000752$1,53211.3 %Total$4,246,0001,693$2,50814 %第122頁/共130頁123Objectives 2009 Increase awareness / drive adoption: Publications KOL management User meetings Podium presence Marketing materials Sales training Start Registry第123頁/共130頁124K

34、OL KOLs for Solitaire AB:Dr. BattacharyaDr. BoccardiProf. HenkesProf. KlischDr. LiebigProf. Turjman KOL and User meetingsLINNC MayESMINTSeptember Podium presentations:Val dIsereLINNCWFITNESMINTICS第124頁/共130頁125UK Case StudyBackground: Stent market was not very well developed Bad experience with Neuroform and Leo Enterprise came in and took whole market第125頁/共130頁126UK Success Factors