1、For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.Completely Retrievable75646(A)DEC/07“Confidential,For Internal ev3,Inc.Use Only,Do Not Di
2、stribute”“Not approved for sale in the United States”For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.Completely Retrievable颅内支架概览“Confide
3、ntial,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable颅内支架分类3“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 Internat
4、ional Sales TrainingFully Deployed.Completely Retrievable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。4For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Use Only,Do Not Dist
5、ribute”“Not approved for sale in the United States”Fully Deployed.Completely Retrievable支架的基础知识与常用术语“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable6开环 vs.闭环闭环设计开环设计“游离”
6、的尖端“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable7颅内支架不同的网眼设计Solitaire AB -Solitaire AB -闭环闭环Leo Plus Leo Plus 闭环闭环Neuroform Neuroform 开开环环Enterprise Enterprise 闭环闭环未连
7、接点未连接点“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable8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。“Conf
8、idential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable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“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not app
9、roved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable10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“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00
10、076 International Sales TrainingFully Deployed.Completely Retrievable11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“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable径向支撑力是
11、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“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable13开环 vs.闭环开环闭环Solitaire AB径向支撑力中/低高高柔软性/顺应性高低高打折和毛刺现象毛刺现象明显光滑光滑支架的结构性支撑好更好最优“Con
12、fidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable14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“Confidential,For In
13、ternal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable15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“Confiden
14、tial,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable16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。“Confidential,For Internal ev3,Inc.Use Only,Do Not Distrib
15、ute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable17潜在并发症1支架内再狭窄(支架内再狭窄(In-stent restenosisIn-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
16、可能导致脑缺血性损伤。“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable18潜在并发症2血栓(血栓(thrombosisthrombosis):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。“Confidential,For Internal ev3,Inc.
17、Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable19潜在并发症3支架移位支架移位边支闭塞边支闭塞其他其他.For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Us
18、e Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.Completely RetrievableSolitaire AB产品信息“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievabl
19、e21*Not approved for sale in the United States.Internal Use onlyFor ev3 Inc.Presentation Use Only Not for Distribution21“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable2
20、2产品结构图解脱点解脱点推送导丝推送导丝导入鞘导入鞘全长全长有用长度有用长度远端标记远端标记近端标记近端标记Internal Use onlyFor ev3 Inc.Presentation Use Only Not for Distribution22“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retri
21、evableSolitaire AB的产品特点23“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable24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“Con
22、fidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable25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型号适用血管直径直径有用长度全长最小微导管内径远端标记近端标记SAB-4-153.04.0 mm4 mm15 mm26 mm0.021 in.31SAB-4
23、203.04.0 mm4 mm20 mm31 mm0.021 in.31SAB-6-205.06.0 mm6 mm20 mm31 mm0.027 in.41SAB-6-305.06.0 mm6 mm30 mm42 mm0.027 in.41“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable
24、26支架短缩Device鞘内长度(mm)释放后长度(mm)短缩率(%)4mm x 20mm37.832.0(4 mm)15.36mm x 30mm52.242.7(6mm)18.1 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。“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United Stat
25、es”CR00076 International Sales TrainingFully Deployed.Completely RetrievableSolitaire AB 支架重叠-4 mm27支架重叠的中点正对支架近端标记.“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable28Sol
26、itaire AB 支架重叠-6 mm“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable29支架网眼重叠试验1st释放C C0.991.691.340.250.671.450.95Cell ACell A0.65Cell BCell BCell CCell CA AB B“Confident
27、ial,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable30支架网眼重叠试验2nd释放A AC CB B0.721.100.95Cell ACell A0.340.820.911.151.441.77Cell BCell BCell CCell C“Confidential,For Internal ev3,Inc.
28、Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable31支架网眼重叠试验3rd释放A AB BC C0.430.970.97Cell ACell A0.320.610.69Cell BCell B1.771.902.62Cell CCell C“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribut
29、e”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable32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For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,Fo
30、r Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.Completely Retrievable支架操作过程“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely
31、 Retrievable34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。“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Complete
32、ly Retrievable操作动画(可替代操作图示).ProductSolitaire ABSolitaire_AB.exe35For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.Completely Retrievable解脱
33、 使用NDS-2解脱盒CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable解脱原理 Covidien|11 July 2025|Confidential44|Insertion Ne
34、edle(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:1.盐水冲洗2.肌肉(+)(-)“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale
35、in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable45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.BNot available for sale in the United StatesThis is picture of NDS-1“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribut
36、e”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable46配件连接线:-1副消毒针(20 G or 22 G)CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the Unite
37、d States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable47Detachment ZoneDetachment ZoneDetachment ZonePushPushWireWireIntroducerIntroducerSheathSheathTotal LengthTotal LengthUsable LengthUsable LengthDistal MarkersDistal MarkersProximal MarkerProximal MarkerInternal Use on
38、lyFor ev3 Inc.Presentation Use Only Not for Distribution47 Electrolytic DetachmentCR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Compl
39、etely Retrievable48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.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales T
40、rainingFully Deployed.Completely Retrievable49患者与器械的连接患者患者将消毒针插在肩膀(或腹股沟处)将“黑线”卡在钢针上。SolitaireSolitaire将“红线红线”卡在支架推送导丝的近端无PTFE涂层处暴露解脱点(确保微导管暴露解脱点(确保微导管未覆盖未覆盖支架解脱点)。支架解脱点)。CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approve
41、d for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable50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.ProductSolitaire ABSolitaire_AB.exeABSolitaire_AB.e
42、xeCR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable操作动画.ProductSolitaire ABSolitaire_AB.exe51“Confidential,For Int
43、ernal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable52成功的支架释放Detached StentDetached StentCR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do No
44、t Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable53SOLITAIRE 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“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United
45、States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable54支架应用Distal Distal markersmarkersProximal Proximal markermarker辅助支撑弹簧圈 贴壁性好贴壁性好 径向支撑力好 可视性佳“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International
46、Sales TrainingFully Deployed.Completely Retrievable磁共振成像相容性 11 July 2025|Confidential55|For ev3 Inc.Presentation Use Only Not for DistributionCR00076 International Sales Training“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”Fully Deployed.C
47、ompletely Retrievable异议处理CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable57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
48、 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable58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
49、丝交叉可能出现交叉电流,导致支架过早解脱。避免推送避免推送导丝导丝交叉交叉干布覆盖支架推送导丝干布覆盖支架推送导丝CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable59假阳性解脱(
50、未解脱)解脱盒已经报警显示解脱,但实际上未解脱CR00049 Rev.BNot available for sale in the United States“Confidential,For Internal ev3,Inc.Use Only,Do Not Distribute”“Not approved for sale in the United States”CR00076 International Sales TrainingFully Deployed.Completely Retrievable解脱的优化方法:解脱前:解脱前:消毒针插在患者消毒针插在患者肩膀或颈部肩膀或颈部。在