CN1308508A - 用于治疗中风和其他小血管血栓栓塞病的栓子切除导管和方法 - Google Patents
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Abstract
用于从血管中清除障碍物(例如,血栓、血栓栓塞物、动脉硬化斑的栓塞片段、异物等)的栓子切除导管、快速更换微型导管、系统和方法。本发明特别适用于在中风发作或脑缺血期间从大脑的小血管中皮下取出血栓栓塞或其他障碍物。在某些实施方案中,本发明的栓子切除导管可以沿着预先插入障碍物或绕过该障碍物的导线推进。另外,在某些实施方案中,所述栓子切除导管包括障碍物捕获容器,该容器在所述导管业已推进到至少部分通过该障碍物时从该导管上展开。所述障碍物捕获容器可以包括ⅰ)至少一个近端支柱,它被设计成可通过血液凝块抽出,和ⅱ)一个远端物体接纳部分,它被设计成阻止血液凝块从中通过。
Description
本发明领域
本发明总体上涉及医疗方法和装置,更具体地讲,涉及栓子切除导管,以及使用所述栓子切除导管的方法,用于从血管腔或其他解剖学通道中取出血液凝块或其他物体。
本发明背景
已知有多种类型的血栓栓塞病,如中风、肺栓塞、外周血栓症、动脉硬化症等发生在人体和其他哺乳动物上。所述血栓栓塞病的典型特征是血栓栓塞(即,包括血小板、血纤蛋白原和其他凝结蛋白的粘弹性血液凝块)的存在,它沉积在血管中的特定部位。
当血栓栓塞症位于静脉血管中时,由血栓栓塞物所产生的障碍有可能导致淤血症状,并在静脉血管内形成所谓的血栓性静脉炎症状。另外,外周静脉栓塞有可能转移到身体的其他部位,在这里可能导致更严重的不利影响。例如,大部分肺栓塞是由于源于外周静脉系统的栓塞物引起的,这些栓塞物后来通过静脉血管转移,并沉积在肺里。
当血栓栓塞物位于动脉中时,会阻断或破坏正常的动脉血液流动,并可能产生组织缺血(缺乏组织所必需的可利用氧气和营养)。在这种情况下,如果不解除血栓栓塞,缺血的组织就有可能被梗塞(即坏死)。根据动脉血栓栓塞的类型和部位,所述组织梗塞可以导致死亡和截肢,心肌梗塞或中风。很显然,在世界范围内,由沉积在大脑的小血管中的血栓栓塞物所引起的中风一直是死亡和残疾的主要因素。
在现代医疗实践中,血栓栓塞病通常是通过下列治疗方法中的一种或几种治疗的:
a)药物治疗,其中,为了溶解凝块和阻止凝块的进一步生长,服用溶血栓剂(例如,链激酶、尿激酶、组织纤溶酶原激活剂(TPA))和/或抗凝药物(例如,肝素、华法林);
b)外科手术(例如,手术栓子切除术或凝块取出),其中,在有凝块沉积的血管上形成一个切口,并通过该切口取出凝块-有时是借助于球形头导管(例如,“Fogarty导管”)完成的,所述导管通过切口插入并进入血管腔,在这里导管的球形头扩张,并用于将凝块取出切口;和
c)基于经血管(transluminal)的导管介入方法,其中,通过皮肤插入凝块取出/破坏导管(例如,具有吸力头的吸入型导管,具有一个凝块捕获容器(例如,蓝、线圈、钩等)的凝块捕获型导管,或具有一个凝块破坏装置(例如,超声波探头或激光的凝块破坏导管),并插入患者脉管,到达靠近凝块的部位。所述吸力头、凝块捕获容器或凝块破坏装置被用于吸出、捕获和取出、破坏或消融相关的凝块。
上述治疗方法中的每一种都具有其自身的优点和缺点。例如,药物治疗的优点是不对身体造成侵害,并且,通常能有效裂解或溶解凝块。不过,用于药物治疗的溶栓和/或抗凝药物可导致有害的副作用,如流血或出血。另外,在时间很重要的情况下,例如,当动脉血栓栓塞导致了严重的组织缺血(例如,引起中风或引起心肌梗塞)时,用溶栓药物完全裂解或溶解血液凝块,并恢复动脉血流所需要的时间可能太长,以至于不能避免或减轻即将发生的梗塞。
在很多情况下,外科手术血栓摘除方法可用于从血管腔中快速取出凝块,但这种外科手术方法会严重损害身体,通常需要整体麻醉,并且,这种外科手术方法的使用通常被局限于身体上可进行手术部分的血管。例如,许多患者所患的中风是由于沉积在无法手术的大脑部位的小的动脉中的血液凝块所致,因此,不能进行外科手术治疗。
基于经血管的导管介入方法对身体的侵害很小,通常不需要进行整体麻醉就可能进行,并且,可以在某些情况下用于从血管腔中快速取出凝块。不过,这种基于导管的介入方法对操作者的技能要求很高,并且在小的或弯曲的血管中很难或不能进行。因此,由于在其大脑的小的弯曲的动脉中存在凝块而患中风的患者,不能用基于导管的经血管的凝块取出方法进行治疗,由于凝块所在动脉的体积太小及其弯曲性。
原则上讲,经血管的可展开的凝块捕获型导管可用于缺血性中风,因为它通常能够取出相关的血液凝块,而不需要抽吸或施加能量(例如,激光、超声波),这种能量会损害大脑中精细的小的血管。不过,现有的经血管的可展开的凝块捕获型导管没有一种被认为具有适用于大脑的小型血管的最佳设计,因为它们a)不具备合适的导线通过腔,以便使其能够通过事先插入的小直径(例如,0.006-0.018英寸)的导线,b)它不适于在导线的标准长度(例如,长度不到导管长度2倍的导线)上进行快速更换,和c)这种导管的凝块捕获容器不是用于从通常出现在大脑中的极小的血管中取出凝块的最佳设计和构造。
现有的经血管的可展开的凝块捕获型栓子切除导管的例子包括披露于以下专利中的导管:US4706671(Weinrib),US4873978(Ginsburg),US5011488(Ginsburg)和PCT国际专利公开号WO97/27808(Wensel等)。不过,由于上述原因和/或其他原因,上述现有的栓子切除导管没有一个被认为是用于治疗缺血性中风的最佳设计。
因此,有必要开发一种新型经血管的可插入的凝块捕获型栓子切除导管,它可以向前推进,并且在预插入的小直径导线上进行更换,它被设计成能从大脑的小的精细的血管中快速、并且选择性地取出血液凝块或其它物质,从而提供对中风发作和其他血栓栓塞症的有效治疗。
本发明概述
本发明总体上包括用于从血管腔或哺乳动物身体的其他解剖通道中取出血液凝块或其他固体的栓子切除导管装置和方法。本发明的栓子切除导管和方法特别适用于从哺乳动物大脑的小的动脉中取出凝块或血栓栓塞物,以便避免中风或减轻中风的严重性。
A.本发明的栓子切除导管
本发明的栓子切除导管装置总体上包括:a)一个长形、易弯曲的凝块穿透导管,它可以向前推进,其远端首先通过要被取出的凝块或其他障碍物(例如,血栓、血栓栓塞物、脱落的动脉硬化斑的碎片、异物等),和b)物体捕获容器,它在进给通过障碍物之后可以从所述导管的远端展开,以便捕获所述障碍物,并有利于取出该障碍物。所述物体捕获容器最初是处在第一种或收藏状态,其中,所述导管呈径向收缩状态并包含在导管上或导管内,或者充分收缩,以便能够通过凝块或其他障碍物体。然后,所述物体捕获容器从可从导管中展开(例如,可推进,可伸出和/或可扩张),使它呈第二种或扩张状态,其中,所述容器可以接纳并至少部分包围凝块或其他障碍物的远端侧,以便将血液凝块或其他障碍物随同导管一起吸取并取出。
一个导线腔可以纵向延伸通过所述导管的整个长度(即,“位于导线”上的实施方案)或仅通过导管的远端部分或通过连接的导线接纳环/突出部分(即,“快速更换”的实施方案)。在导管的任一种实施方案中,所述导线腔可以延伸通过所述物体捕获容器,以便导管(连同其处于收缩或收藏状态的物体捕获容器)可以在预先已经通过血管障碍凝块或其他障碍物的导线上进给。另外,导管腔的这种结构使得栓子切除导管可以更换(例如,去掉并更换另一个栓子切除导管或另一种导管),如果有必要或需要进行这种更换的话。让导线保持处在通过所遇到的凝块或其他障碍物中的能力,能够确保所述导管或其代替物可以再进给通过所述凝块或其他障碍物。
所述导管的物体捕获容器可以包括一个具有多孔结构(例如,金属丝、纤维或织物形成的编织、卷曲或网状结构)的远端障碍物接合部分(例如,线圈、蓝或凹形件),该部分通过一个或几个近端支柱,(例如,连接件(例如,若干细金属丝或支柱))连接于所述导管上。首先,所述物体捕获容器处在其第一种(例如,收缩或收藏)状态,所述导管的远端向前推进通过凝块或其他障碍物。在所述导管业已推进通过所述凝块或其他障碍物之后,所述物体捕获容器移动到第二种(例如,扩张的或工作的)状态,以便所述容器的远端障碍物接合部分16能够接触和/或至少部分包围所述凝块或其他障碍物的远侧面。所述容器的远端障碍物接合部分优选具有可透过结构,以便血液可以通过它流动,但又有足够密集(即,有足够的不可渗透性,以便阻止凝块或其他障碍物从其中通过。这样,所述容器的远端障碍物接合部分可用于沿近端方向从当时所处的位置收回或抽出凝块或其他障碍物。分布在容器和导管之间的近端支柱通常具有径向扩张的或向外倾斜的结构,并进行优选设计、定向和定位,以便当其在凝块或其他障碍物的远侧部位展开时割开、切开或以其他方式通过所述凝块或其他障碍物,然后沿近端方向收缩。为了帮助所述近端支柱通过所述凝块或其他障碍物,可以在其近端通过所述凝块或其他障碍物缩回时,对所述近端支柱施加能量(例如,射频能量、振动、加热等)。
可以在所述栓子切除导管的近端部分设置一个对照介质注入口,以便当导线保持定位在导线腔中时可以通过所述导管注入X光照相对照介质(例如,染料)。
B.可和本发明的栓子切除导管结合使用的快速更换微型导管
另外,根据本发明,提供了一种快速更换微型导管,它包括一个常用于神经放射学方法的小直径柔性微型导管(例如,ProwlerTM微型导管,Cordis Endovascular系统,迈阿密湖,佛罗里达),在其远端或接近其远端的柔性,大于在其近端或接近近端的柔性。并且,根据本发明,它包括设在该导管侧壁上的距离其远端一隔开距离(例如,0.5-35厘米)的导线通过孔。(或者,在导管体的侧面设置一个导线可接纳环或突出部分)。可以在所述导管的主腔中靠近导线通孔的部位设置一个导线偏转器,以便当所述导管在所述导线上推进时偏导所述导线的近端,使其从所述导线通过孔中出来。所述导线通过孔和导线偏转器的设置使得导线仅能通过所述导管腔的远端部分。这种腔结构使得所述微型导管能进行更换(即,取出并用上述设计的另一种微型导管或栓子切除导管更换),同时,操作者通过抓住所述导线的外部的近端将该导线固定在原位——即使在使用标准长度导线(即,不是“更换长度”的导线)时也是如此。
C.用于从血管中取出凝块或其他物体的本发明方法
另外,根据本发明,提供了一种用于治疗由沉积在大脑的小血管中(即,位于大脑中或大脑周围的血管)的血栓栓塞物所导致的缺血性中风的方法。本发明的方法可以用本发明的快速更换微型导管和栓子切除导管实现。优选方法一般包括下列步骤:
A.使用皮下导线置入的Seldinger技术或其他合适方法从皮下将导线(单独或与导管结合)插入颅内血管中;
B.沿所述导线进给一个微型导管,或者与所述导线分开地进给,使其通过脉管,直到所述微型导管接近血液凝块或其他障碍物所处的部位;
C.在X光照相观察条件下,使X照相对照介质(例如,染料)通过所述微型导管,以便确定所述障碍物的确切位置和/或对所述障碍物部位的血管解剖结构进行照影;
D.通过所述微型导管进给所述导线(或一个独立的小导线),直到所述导线位于相对所述障碍物的理想手术部位(例如,使其远端完全或部分越过或穿过血栓栓塞物或其他障碍物);
E.抽出和取出所述微型导管,同时,基本上保持所述小导线处在其手术位置上(例如,阻止所述导线运动,从而脱离与可供该导线手术的所述障碍物的接触);
F.沿可操作地定位的导线进给具有一个可从它上面展开的障碍物捕获容器的物体捕获型栓子切除导管(如本发明的栓子切除导管),直到该栓子切除导管的远端完全进入或者至少部分通过所述障碍物(例如,业已插入障碍性血栓栓塞物);
G.通过所述栓子切除导管腔选择性地注入X光照相对照介质,以便引导或证实该栓子切除导管相对沉积的血液凝块或其他障碍物的定位;
H.展开所述栓子切除导管的障碍物捕获容器,以便使它确保在沉积的血液凝块或其他障碍物的远端(即下游)部位,呈其第二种或扩张状态);
I.退回所述障碍物捕获容器,以便该容器的近端部分(即近端支柱)通过所述血栓栓塞物,并至少有一部分所述凝块或其他障碍物位于该障碍物捕获容器的障碍物容纳部分;
J.通过所述栓子切除导管腔选择性地注入X光照相对照介质,以便确定血管中以前因为凝块或其他障碍物的存在而丧失了血液流动的部分是否已经恢复了血液流动;和
K.退出所述栓子切除导管,以便从体内取出血液凝块或其他障碍物(例如,通过皮下的进入通道抽出所述栓子切除导管和所摘除的凝块或其他障碍物,所述导管事先就是通过该通道插入的)。
因此,通过本发明的上述方法,取出了导致缺血性(即,血栓或栓塞)中风的血液凝块或其他障碍物,并恢复了大脑中由于在血管中沉积了相关的血液凝块或其他障碍物所造成的缺血的部位的动脉血液流动。
本领域技术人员通过阅读并理解下面的优选实施方案的详细说明并结合附图,可以理解本发明的其他要素、目的和优点。
附图的简要说明
图1是使用了本发明的栓子切除导管的第一种实施方案(位于导线上的实施方案)的人类患者的透视图。
图1a是可操作地定位在一个导线上的图1所示栓子切除导管装置的透视图,它的障碍物捕获容器处在扩张状态。
图2a是图1所示位于导线上的栓子切除导管的远端的放大的纵向剖视图,其障碍物捕获容器处在第一或收藏状态。
图2b是图1所示位于导线上的栓子切除导管的远端的放大的、断开的、纵向剖视图,其障碍物取出件处在远端推进位置上,而其障碍物捕获容器处在完全扩张的状态。
图2c是通过图2a的线2c-2c的横剖视图。
图2d是通过图2a的线2d-2d的横剖视图。
图2d’是通过图2a的线2d-2d的横剖视图,对其作过改进,以便显示在所述远端件中导向孔的另一种结构形式,构成障碍物捕获容器的导线通过该孔插入。
图3a是现有位于导线上的微型导管的远端的放大的、断开的、纵向剖视图。
图3b是本发明栓子切除导管的第二种实施方案(即另一种位于导线上的实施方案)的远端的放大的、断开的、纵向剖视图。
图3b’是通过图3b的线3b’-3b’的横剖视图。
图3c是本发明快速更换微型导管的远端的放大的、断开的、纵向剖视图。
图3c’是通过图3c的线3bc’-3c’的横剖视图。
图3d是本发明栓子切除导管的第三种实施方案(即快速更换实施方案)的远端的放大的、断开的、纵向剖视图。
图3d’是通过图3d的线3d’-3d’的横剖视图。
图3e是本发明栓子切除导管的第四种实施方案(即另一种快速更换实施方案)的远端的放大的、断开的、纵向剖视图。
图3e’是通过图3e的线3e’-3e’的横剖视图。
图3f是本发明栓子切除导管的第五种实施方案(即另一种快速更换实施方案)的远端的放大的、断开的、纵向剖视图。
图3f’是通过图3f的线3f’-3f’的横剖视图。
图4是图3d的栓子切除导管的第三种实施方案(即快速更换实施方案)的透视图,它具有一个可操纵地插入其导线腔中的导线,并且其障碍物捕获容器处在展开的、径向扩张的状态。
图5是可用在本发明的任一种栓子切除导管上的第一种可选择的障碍物捕获容器的透视图。
图5’是图5的部分5’的放大视图。
图5”表示图5的部分5’的另一种结构。
图5a是图5的远端视图。
图5b是可用在本发明的任一种栓子切除导管上的第二种可选择的障碍物捕获容器的透视图。
图5b’是图5b的第二种可选择的障碍物捕获容器的透视图,在该容器中捕获了一个血液凝块,并且其支柱已部分收回到导管中。
图5b”是图5b的第二种可选择的障碍物捕获容器的透视图,在该容器中捕获了一个血液凝块,并且其支柱进一步收回到所述导管中,以便所述障碍物捕获容器被收回部分包围所捕获的凝块。
图5c是可用在本发明的任一种栓子切除导管上的第三种可选择的障碍物捕获容器的透视图。
图6是本发明的选择性的导管的透视图,具有一个可从它上面展开的近端障碍物容器装置,以及一个可操作地插入其中的本发明的栓子切除导管。
图7是图1、2b和4所示导管的障碍物捕获容器的螺旋型蓝的一种变体的正视图,所述变体是由金属条而不是金属丝构成。
图7a是通过图7的线7a-7a的横剖视图,表示所述金属条的缠绕方式,以便增强所述近端支柱部分支持所述障碍物捕获容器切割通过血栓栓塞材料的能力。
图8a-8f是一种方法的分步示意图,其中,将本发明的栓子切除导管的第一种实施方案(即,位于导线上的实施方案)用于从哺乳动物身体上的小的血管中取出血液凝块。
图9a-9d是一种方法的分步示意图,其中,将本发明的栓子切除导管的第三种实施方案(即,快速更换实施方案)用于从哺乳动物身体上的小的血管中取出血液凝块。
通过阅读并理解下面的详细说明,可以理解在上述附图中所示的具体实施方案,以及本发明的其他实施方案,其中,具体参见在附图中说明或表示的结构和步骤。
本发明详细说明
A.栓子切除导管装置的位于导线上的实施方案:
参见附图,其中,图中所示是为了说明并解释本发明的代表性实施方案的,而不是为了限定本发明的范围,图1表示一个人类患者,在他身体内业已插入了本发明的栓子切除导管装置10的位于导线上的实施方案,以便从位于该患者大脑中的小的动脉中取出血栓栓塞物或血液凝块。在插入导管装置10之前,业已通过血管造影术或其他照相方法对相关的凝块进行了定位,并将一个小的(例如0.006-0.010英寸外径)导线GW插入患者的股骨动脉,并推进到存在血液凝块的大脑的动脉中,并且至少部分穿过该凝块。然后,沿预先插入的导线GW插入导管装置10,达到使导管装置10的远端接近所述凝块的位置。
第一种实施方案
如图1-2e所示,位于导线上的导管装置10的第一种实施方案包括一个长形的柔性导管11,如图所示,它有一个可从其远端DE展开的凝块捕获容器14。所述障碍物捕获容器14是由若干(例如,2个或2个以上)金属丝元件20构成,该容器最初可在导管11中收缩成大体上垂直的形状和第一种(即,收藏)状态(参见图2a)。当它需要展开障碍物捕获容器14时,预先成型的金属丝元件20沿远端方向推进,以使其从导管11的约束中脱出,并弹性地形成第二种(即工作)状态,其中,构成螺旋型蓝16的金属丝元件的远端部分具有一个开放的近端开口或圆边17,如图2b所示。当处在这种工作状态(图2b)时,螺旋型蓝16具有足够的孔隙度,以便让血液能够从中流过,但又足够密集,以便卡住并沿近端方向取出血栓栓塞物。在金属丝元件18的远端装有一个顶端锥体30。长形金属丝元件20的近端部分18在螺旋型部分16和导管11之间起着连接件的作用。所述金属丝元件20的近端部分18具有足够小的直径或者被制成能够收缩通过血栓栓塞物,而不会导致对血栓栓塞物的明显破坏或分解。在某些实施方案中,可以对金属丝元件20的近端部分18施加能量(例如,加热、振动等),以便有利于其从血栓栓塞材料中缩回而又不会导致血栓栓塞物的明显破坏或分解。
构成捕获容器14的金属丝元件20可以是任何合适的材料,如弹性的、超弹性的或形状记忆合金金属丝。所述金属丝元件的远端被预先成型形成螺旋型蓝16的形状,但又有足够的弹性,以便当其收缩通过导线孔26并进入导管11时呈大体上垂直的状态,并且在小的近端方向压力的作用下保持收紧状态(参见图2a)。不过,当所述预先成型的金属丝元件延伸或者向前推进通过导线孔26并从导管11的远端DE出来,并且解除了导管11的周向约束和近端方向的张力时,它就会弹性地自动卷曲成螺旋型吊蓝16的大体上呈截头锥体形状。
为了便于做理想的向前推进和收缩运动,将所述预先成型的金属丝元件20、所述元件20的近端连接在位于导管体12的腔22中的可纵向滑动的致动器24上。一个中空的致动器腔22a穿过致动器24,并且与导管体12的腔22轴向对齐。在致动器24的轴中设有具有一个金属丝编织物或线圈25,以便对其进行加固和加强。在导管体12的远端DE设有一个远端件28,所述远端件28具有一个中空的末端件腔22TM,该腔纵向延伸通过其中央,并具有4个金属丝通过孔26,这些孔从径向分离的位置(即,3,6,9和12时针位置)纵向延伸从中通过。远端件28可以由硬度比导管体12更大的材料制成,并可以具有一个直径逐渐变小的部分40,该部分被插入导管体腔22的远端DE,如图2a、2b和2d所示。构成障碍物捕获容器14的4个预先成型的部分20的每一个在向前推进从导管11中出来时,必须通过设在导管末端件28上的金属丝通过孔26中的相应的一个。图2d’表示所述远端件的另一种结构,其中,在时钟的3、6、9和12小时的位置上设有4个切槽26A,T,它起着单独的金属丝部分20的独立的导线通道作用,代替金属丝通过孔26。
一个近端致动器轴24’延伸到设在所述导管近端的外壳13中,并且该近端致动器轴24’可以用手推进和收回,以便控制障碍物捕获容器14的展开和收紧。在所述近端外壳13上还设有一个对照介质注入口15,以便通过腔22由导管11的远端DE注入X光照相对照介质。就此而言,导线GW的外径优选至少略小于腔22的内径,以便即使当导线位于腔22中时,某些X光照相对照介质仍然能通过腔22由导管的远端注入。另外,可以选择具有很低粘度的X光照相对照溶液(即染料),以便增强该对照介质在导线GW存在于腔22中时通过该腔的能力。
当致动器24沿近端方向抽出时,它会沿近端方向拉金属丝部分20,使其通过金属丝通过孔26,并进入导管的腔22。如图2a所示,当致动器24被完全抽出时,部分20会完全拉过金属丝通过孔26,并且呈大体上垂直的状态,并且安装在障碍物捕获容器的远端的顶端锥体30会直接贴近导管末端件28上,以便中空的顶端锥体腔22NC与所述远端腔22DT和导管体12的腔22轴向对齐。
第二种实施方案
图3b和3b’表示位于导线上的导管装置10’的第二种实施方案,它与第一种实施方案10有几方面的不同。例如,第二种实施方案的障碍物的捕获容器(未示出)仅由2根金属丝元件20’而不是像第一种实施方案10中那样由4根构成。另外,第二种实施方案的导管11’采用了具有逐渐变小的直径和增加了的柔性的长形远端部分70——类似于市售微型导管的远端部分(例如,ProwlerTM微型导管,CordisEndovascular系统,迈阿密湖,佛罗里达),它的一个例子如图3a所示,并且总体上包括一个腔L的近端部分PP,和具有腔271的远端部分270,它与近端部分PP的腔L是连接的。
特别参见图3b和3b’,所述位于导线上的栓子切除导管装置10’的第二种实施方案包括一个长形的柔性导管11’,它具有一个类似于第一种实施方案的螺旋型蓝形障碍物捕获容器(未示出),不过,其中,该容器(未示出)仅由2根金属丝元件构成。如在上面的第一种实施方案中所述,第二种实施方案10’的障碍物捕获容器(未示出)最初收缩成第一种(即收藏的)状态,并且随后可以推进成第二种(即可工作的)状态,大体上与在结合第一种实施方案10进行的说明相同。
在第二种实施方案中,柔性导管11’包括一个具有第一直径和第一柔性的近端部分12’,和具有第二(即较小的)直径和第二(即较大的)柔性的远端部分270。具有4个纵向延伸的导向孔26’的插入件28’被安装在导管11’的远端部分270的腔271’中,并且与该腔同轴延伸。插入件28’大体上是一种圆柱形件,在它上面有4个纵向分布的孔20’,如图3b’所示。不过,由于该实施方案的障碍物捕获容器(未示出)仅由2根长形元件20’构成,其余的2个导向孔26’未被占据,并可以用作通道,X光照相对照介质(例如染料)、药物、灌注溶液或其他流体可以通过该通道流动。
B.栓子切除导管装置的快速更换实施方案
图3d、3d’、3e、3e’、3f、3f’和4表示栓子切除导管装置10”、10和10""的快速更换实施方案。所述快速更换的栓子切除导管装置10″、10和10""采用了仅通过导管11″、11、11""的导管腔,以便可以更换导管11″、11、11"",而又不必使用更换长度的导线(即,具有足够长度的导线,使得该导线的外部长于所述导管,以便该导管可以抽出、取出并更换,同时所述导线保持大体上固定的位置)。这种快速更换实施方案特别适用于通过从大脑的小的血管中(即,位于大脑上、大脑内或大脑周围的血管)取出血栓栓塞物治疗中风,因为在这种精细的神经放射学方法中使用交换长度的导线可能是不理想的。参见Morris,P.,实践神经放射学,第二章,41页(Williams&Wilkins 1997)。
第三种实施方案
图3d和3d’表示栓子切除导管装置10”的第三种实施方案(即快速更换实施方案),它在结构上类似于上述第二种实施方案10’,它采用了设在距离其远端一定距离(例如,0.5-35厘米)的、位于导管11”的侧壁上导线通过孔267’,以及一个从导线通过孔267’延伸到腔22’的导线偏导管260’。该导线偏导管260’具有一个喇叭形的远端,通过若干径向支撑件264’将其保持在所述腔中的中央位置。在径向支撑件264’之间设有纵向通道266,266(alt),以便X光照相对照介质或其他流体可以流过腔22’,并通过导线偏导管260’的喇叭形远端。一个选择的纵向通道266(alt)大于另一个通道266,以便构成障碍物捕获容器的长形元件20’能够从中通过,如图所示。导线的近端PEG可以插入导管11”的远端开口DEO,然后,导管11”可以沿远端方向推进,以便导线的近端PEG能进入导线偏导管260’的喇叭形远端,并引导其离开所述侧面导线通过孔267’,如图所示。
第四种实施方案
在图3e和3e’中所示的第四种实施方案(即另一种快速更换实施方案)中,导管11包括一个主管300,它有一个具有第一直径D1的近端部分302,和一个具有第二直径D2的远端部分304。一个侧面管308被连接在主管300的远端部分304的一侧,并在侧管308的腔309中设有一个导线通过孔310,以便所述侧面管的腔309可以用作导线腔,并且从侧面管腔309中出来的导线GW的远端部分随后可以通过障碍物捕获容器22(在图3e中未示出)的独立的导线腔和/或任何顶端锥体腔22NC(在图3e中未示出),如上文所充分说明的。
第五种实施方案
栓子切除导管装置10""的第五种实施方案(即另一种快速更换实施方案)与上述第四种实施方案10在结构上相似,并且在操作上相同,所不同的是第五种实施方案10""的主管300’是由一个连续的金属丝316构成,如图所示,它呈一种紧密的螺旋型线圈形式。主管300’的这种结构相对其他形式结构而言具有较大的柔性。
C.可用于所述栓子切除导管装置的任一种实施方案中的其他元件和选择性元件:
1.其他类似的障碍物捕获容器:
本发明的栓子切除导管装置10、10’、10″、10、10""可以采用各种类型的障碍物捕获容器取代图1a、2b和4中所示螺旋型金属丝蓝形容器14、14’。具体地讲,在图5-1中示出了若干其他类型的障碍物捕获容器。
图5-5a表示另一种障碍物捕获容器400,它包括若干弹性或超弹性金属丝辐条402,如图所示它被预先成型成径向扩张的形状,在它上面还装有一个薄膜状或织物状表层404,以便形成伞状结构。所述薄膜状或织物状表层404可以是无孔的或有孔的结构,并且优选由诸如聚乙烯、聚四氟乙烯、聚亚胺酯、乙烯乙酸乙烯酯或硅氧烷的材料制成。在所述辐条402的中央形成一个中央轮毂,一个导线腔延伸通过该中央轮毂,以便所述导线可以图5和5a所示方式通过容器400的中央。在辐条402的末端设有球体408,以便减轻对周围的血管壁的创伤,如图5’所示。或者,可以在辐条402的远端设置非创型环410取代所述球408,以避免对血管的创伤。辐条402具有足够小的直径,以便能通过血栓栓塞物收回,而不会导致血栓栓塞物的明显破坏或分解。另外,在图5所示实施方案中,可以理解的是,辐条402可以具有比图中所示更大的弯曲度,以便辐条402的自由末端不会直接接触血管壁。
图5b-5b”表示另一种障碍物捕获容器420,它包括若干弹性或超弹性金属丝辐条402’,如图所示,它被预先成型成径向扩张的形状,以及连接在辐条402’上的有孔的织物(例如,纺织物、针织物、网或网状织物)囊422,以便形成图中所示的伞状结构。用于生产囊422的材料可以是上文所述用于生产例5中所示实施方案的膜状或织物表层404的相同的微孔型材料。在囊422上形成一个中央孔426,以便导线GW可以通过辐条402’的一部分,并通过所述孔426,如图5b和5b’所示。牵引线424连接在辐条402’的自由末端,并且通过导管腔。所述牵引线424和辐条402’具有足够小的直径,以便可以通过血栓栓塞物收回,而又不会对血栓栓塞物造成明显的破坏或分解。在容器420业已向前推进通过血栓栓塞物后,它会展开(例如,径向扩张),并收回,以便牵引线424和辐条402’收缩通过所述血栓栓塞物,并位于靠近该栓塞物之处。然后,牵引线424可以退回到导管中,向内拉辐条402’的远端,以便所述囊的近端口PM以图5b’和5b”的方式被拉至部分环绕被捕获的障碍物。
图5c表示另一种障碍物捕获容器,它采用了一种弹性的、大体上如足球形状的笼子,以便实现膜状或织物表层444径向扩张/收缩。如图所示,所述笼子包括大约6个预先成型的弹性、超弹性或形状记忆金属丝的长形件442,这些长形件环绕纵向轴LA纵向放置,并具有设置在其远端部分DP上的膜状或织物表层444。长形件442的远端DE连接在顶端锥体446上,有一个导线通过腔纵向延伸通过该锥体。当件442退回到导管腔中时,它会径向收缩到能够纳入所述导管腔的直径。不过,当其向前推进离开导管之后,件442会弹性扩张成所示形状。所述件的近端部分的直径足够小,以便切、割或以其他方式沿近端方向通过血栓栓塞物或凝块,而不会对血栓栓塞物或凝块造成破坏或导致分解。
图7和7a表示另一种螺旋型蓝形障碍物捕获容器14”,它与图1a和4中所示的螺旋型蓝形容器14、14’在形状上大体相同,在操作方式方面相同,不过,其中,容器14”是由若干平的金属条500制成,如钴、铬-镍合金(ElgiloyTM,Elgiloy公司,Elgin,Illinois),形状记忆和/或超弹材料,如镍-钛合金,或其他合适的金属或塑料。所述扁平条500的远端被预先成型成螺旋型形状,以便形成螺旋型蓝502。所述条500的近端部分起着螺旋型蓝502和导管之间的连接件504的作用。每一个条500具有第一和第二扁平表面512,以及第一和第二边缘514。每一个条500在连接件504和螺旋型蓝502之间的过渡点510处扭转90度。所述条的这种扭转会导致a)其远端部分的边缘514并列定位,以便容纳在螺旋型蓝502中的血栓栓塞物会停留在条500的扁平的表面上,以及b)其近端部分的边缘朝向近端方向定位,以便远端连接件504能通过血栓栓塞物收回,而不会对血栓栓塞物造成明显的分解或破坏。
选择性的导向导管/近端障碍物限制件:
如图6所示,有可能希望与导向导管50一起组合使用栓子切除导管装置10、10’、10”、10、10"",栓子切除导管11可以通过导向导管插入。当使用导向导管50时,一个近端障碍物限制件52,如具有诸如图5所示的径向扩张的并且可展开的远端的管状鞘,可以向前推进从导向导管50的远端DE中出来,以便凝块C或其他障碍物可以被捕获在容器14的远端障碍物容纳部分16和近端障碍物限制件52的扩张的远端之间。这种选择性的近端障碍物限制件52的使用特别适用于血栓栓塞物是非常新鲜的、或者已经被意外地破碎或分解的场合,以避免在取出过程中发生破坏或分解的危险。
D.可用于与栓子切除导管结合的快速更换微型导管:
在很多方法中,本发明的栓子切除导管被用于从大脑的小的血管中取出血栓栓塞物,有必要首先对被认为存在血栓栓塞物的血管进行血管照相,以便a)确定血栓栓塞物的确切位置,和b)在所述血栓栓塞物所在的部位对血管解剖学进行X光照相,和c)引导小的导管通过相关的血栓栓塞物并证实其通过情况。由于本发明的栓子切除导管10、10’、10”、10、10""必须具有很小的直径(例如,0.10-0.20英寸)以便通过大脑的细小的血管,被抽回的障碍物捕获容器14、14’、400、420或440在导管11中的存在,会严重限制可以通过导管11注入的X光照相对照介质的量。因此,在很多场合下,需要首先插入一个小的血管照相导管(一种诸如ProwlerTM的微型导管,CordisEndovascular系统,迈阿密湖,佛罗里达),该导管的一种例子如图3a所示,将该导管插入被堵塞的血管中,以便进行初步的血管照相,并实现导线通过血栓栓塞物的精确定位。在所述初步的血管照相业已完成,并且导线业已精确定位之后,将血管照相导管抽回并取出,将导线留在原处。然后,沿预先放入的导线将本发明的栓子切除导管10、10’、10″、10、10""推进到血栓栓塞物的部位。
不过,现有微型导管的设计不适合这种新的方法。迄今为止,这种“位于导线上的”类型的微型导管主要用于导管和与它一起插入的导线同时抽回并取出的方法中。因此,正如本领域技术人员所理解的,现有的“位于导线上的”类型的微型导管只能在固定导线上进行更换,如果该导线是“可更换长度“的导线的话,或者如果在导线的近端连接有一个延长部分以便可进行交换的话。不过,所述“可交换长度的”导线或导线延长部分的使用不能用于这样的方法中:其中导管被插入大脑的细小精微的血管中并从中取出。参见Morris,P.,实践神经放射学,第2章41页(Williams&Wilkins,1997)。
鉴于现有微型导管的这种缺陷,申请人业已设计出了图3c和3c’所示的快速更换微型导管265。这种快速更换微型导管265包括一个长形的柔性导管,该导管具有一个具有第一直径和第一柔性的近端部分12”和一个具有第二(即较小的)直径和第二(即较大的)柔性的远端部分270”。在导管的靠近其近端部分12”的远端的侧壁上设有一个导线通过孔267,以及一个从导线通过孔267延伸到腔271的导线偏导管260。导线偏导管260具有一个喇叭形远端,通过若干径向支撑件264将其固定在所述腔的中央位置。在径向支撑件264之间设有纵向通道266,以便X光照相对照介质或其他流体可以流过腔271,通过所述导线偏导管260的喇叭形远端。导线的近端PEG可插入导管的远端开口DEO,然后,可沿远端方向插入导管,以便导线的近端PEG能进入导线偏导管260的喇叭形远端,并被偏导离开所述侧面导线通过孔267,如图3c所示。
E.用本发明从血管中取出凝块或其他障碍物的方法:
图8a-8f表示使用本发明的位于导线上的类型的栓子切除导管10取出诸如血栓栓塞物或血液凝块的障碍物的优选方法,而图9a-9c表示用本发明的快速更换型栓子切除导管10”取出所述障碍物的优选方法。在下面的段落中将对所述代表性方法作详细说明。
位于导线上的栓子切除导管的优选用途
图8a-8f表示本发明的用图1-2d所示位于导线上的类型的栓子切除导管10取出位于动脉叉BE下游的血栓栓塞物或凝块C的优选方法,所述凝块C会在凝块C的下游形成组织的缺血部位IZ(例如,缺乏氧气和其他养分的脑组织)。在以上附图中所表示的优选方法将在下面的段落中说明。
首先,将诸如图3c所示的快速更换微型导管265的微型导管(在图8a-8f中未示出)推进到靠近障碍物或凝块C的位置,并通过该微型导管注入X光照相对照介质,以便通过血管照相确定凝块C的确切位置,并对凝块所在部位的血管解剖学进行观察或照相。然后,通过微型导管265的腔271插入一个直径为0.01-0.014英寸、其长度不超过微型导管265的长度1.5倍的导线(即,不是“更换长度”的导线),直到其远端DT业已通过凝块C,如图8a所示。
然后,由操作者抓住导线GW的近端,以避免在抽回并取出快速更换微型导管265时将导线GW纵向抽出。这样使得导线GW保留在图8a所示的工作位置上。
然后,如图8b所示,沿导线GW插入被收缩成第一种状态的障碍物捕获容器(图2a),并穿过凝块C,以便导管11的远端开口DEO位于凝块C的下游,但仍然接近(位于上游)导线GW的远端DT。
然后,如图8c和图8d所示,沿远端方向推进致动器28,以便使得构成障碍物捕获容器14的4根金属丝部分20向前离开所述导管的远端,以便顶端锥体30保持在导线GW上。这样,障碍物捕获容器14在远离(即位于下游)凝块C的部位上完全展开成第二种或工作状态(图3d)。
然后,如图8e所示,沿近端方向退出栓子切除导管11,使得障碍物捕获容器14的近端连接件18通过所述凝块,并进一步导致所述凝块被纳入容器14的远端障碍物容纳部分16的凹陷或凹入的内部,如图所示。
然后,如图8f所示,可将整个栓子切除导管10连同所拖曳的凝块C抽出身体-或转移到较大血管的部位(例如,颈动脉),在这里,可将凝块C和完全展开的障碍物捕获容器14纳入较大的导管腔,以便进一步确保所述凝块被最终从体内摘掉并取出。
快速更换切除导管的优选用途
在图9a-9d示出了使用本发明的快速更换型栓子切除导管10”的优选方法。
首先,将诸如图3c所示的快速更换微型导管265的微型导管(在图9a-9d中未示出)推进到靠近凝块C的位置,并通过该微型导管注入X光照相对照介质,以便通过血管照相确定凝块C的确切位置,并对凝块所在部位的血管的解剖学进行观察或照相。然后,通过微型导管265的腔271插入一个直径为0.006-0.18英寸、其长度不超过微型导管265的长度1.5倍的导线(即,不是“可更换长度”的导线),直到其远端DT业已通过凝块C,如图9a所示。
然后,由操作者抓住导线GW的近端,以避免在退回并取出快速更换微型导管265时将导线GW纵向抽出。这样使得导线GW保留在图9a所示的工作位置上。
然后,如图9b所示,将所述导线的位于外面的近端插入快速更换栓子切除导管11”的远端开口DEO,同时将障碍物捕获容器收缩成第一种状态(图2a)进入导管11”的远端部分。随着所述导管沿导线GW沿远端方向推进,该导线被导管偏导管260’偏导(参见图3d),并且导线的近端会离开导管11”的侧面导管通过孔267’。向前推进导线11”使其通过凝块C,以便导管11”的远端开口DEO位于凝块C的下游,但仍然接近(位于上游)导线GW的远端DT,如图9c所示。如图所示,导线GW沿着快速更换导管11”的近端部分(即,导管靠近所述导线通过孔267’的部分)的侧壁延伸。
然后,如图9d所示,致动器28沿远端方向推进,导致构成障碍物捕获容器14’的两个金属丝件20’向前离开导管11’的远端,以便顶端锥体30’留在导线GW上。这样,障碍物捕获容器14’在远离(即位于下游)凝块C的位置上被充分展开成第二种或工作状态(图9d)。
然后,沿近端方向退回快速更换栓子切除导管11’,导致障碍物捕获容器14’的近端连接件18’通过所述凝块,并进一步导致该凝块被纳入容器14’的螺旋型蓝16’的凹陷或凹入的内部。然后以上文所述和在图8e和8f中所示的相同方式通过抽回导管11’取出凝块C。
可以理解的是,本文结合某些代表性实施方案对本发明进行了说明,并没有试图对本发明的每一种可能的实施方案进行穷举性说明。事实上,正如本领域技术人员可以理解的,在不脱离本发明的构思和范围的前提下,可以对上述实施方案进行各种增加、减少、改进和/或改变。所有上述增加、减少、改变和改进都应当被包括在下面的权利要求书的范围内。
Claims (77)
1.一种用于从血管中取出血液块或其他障碍物的栓子切除导管装置,该装置包括:
一个细长柔性导管体,其具有一近端,一远端和一通过其至少一部分纵向延伸的导线腔;
一个障碍物捕获容器,它首先处于收藏状态,在这种状态下它可通过所述障碍物,并且,然后展开成第二种径向扩张的状态;
所述障碍物捕获容器具有一个通过其纵向延伸的导线腔,与所述导管体的导线腔对齐,以便所述障碍物捕获容器和所述导管体可以在预先放置的导线上被推进。
2.如权利要求1的栓子切除导管装置,其中,所述障碍物捕获容器是足够地多孔的,以便血液可以通过它流动,但又是足够地非多孔的,以便阻止血液凝块从中通过。
3.如权利要求2的栓子切除导管装置,其中,所述障碍物捕获容器上设有100-1000微米的孔,以便提供25%-90%的孔隙度。
4.如权利要求1的栓子切除导管装置,其中,所述障碍物捕获容器是由预先成型的、弹性材料制成,当它被收入所述导管时被收缩成所述第一种状态,并且,当它从所述导管中出来时就会扩张成所述第二种状态。
5.如权利要求4的栓子切除导管装置,其中,所述障碍物捕获容器是由在体温下具有超弹性的材料制成。
6.如权利要求5的栓子切除导管装置,其中,所述障碍物捕获容器是由在体温下具有超弹性的镍-钛合金制成。
7.如权利要求1的栓子切除导管装置,其中:
所述导管还包括若干延伸通过该导管远端的件导向通道;
所述障碍物捕获容器包括若干长形件,这些长形件被预先成型成螺旋型形状,并且延伸通过在所述导管的远端上形成的导向通道;
所述长形件可沿近端方向通过导向通道缩回,由此它们取大体直线的形状,
所述长形件可以沿远端方向通过所述导向通道进给,以便它们能够取大体上为螺旋型的形状,并且形成所述大体上为凹入的凝块捕获容器。
8.如权利要求7的栓子切除导管装置,还包括一个在所述长形件的远端上形成的末端件,所述容器的导线腔延伸通过所述末端件。
9.如权利要求1的栓子切除导管装置,还包括:
一个形成在所述导管体的近端上的近端连接件,所述近端连接件具有形成在它上面的注入孔,以便通过所述导管体的腔将X光照相对照介质注入,同时导线被放置在该导管体的导线腔中。
10.如权利要求1的栓子切除导管装置,其中,所述长形件的远端部分被偏压成构成所述障碍物捕获容器的远端障碍物容纳部分的形状。
11.如权利要求1的栓子切除导管装置,其中,所述长形件的远端部分在不受到约束时形成所述容器的远端障碍物容纳部分,而所述长形件的近端部分会形成从所述导管体延伸到所述容器的远端障碍物容纳部分的支柱。
12.如权利要求11的栓子切除导管装置,其中,所述支柱被设计成并且定位成当其沿近端方向抽出时能够通过凝块,但所述容器的远端障碍物容纳部分足够密集,以防所述凝块从中通过。
13.如权利要求1的栓子切除导管的位于导线上的实施方案,其中,所述导线腔大体上通过整个导管体纵向延伸。
14.如权利要求1的栓子切除导管的快速更换的实施方案,其中,所述导管还包括一个设在该导管上的靠近该导管远端一间隔距离的导线通过孔,并且其中,在该导管内导线腔至少从所述导线通过孔延伸到该导管的远端。
15.如权利要求14的栓子切除导管装置,还包括一个位于所述导线腔中的导线偏导器,其被设计成当所述导管沿远端方向在导线上进给时偏导所述导线的近端离开所述导线通过孔。
16.如权利要求15的栓子切除导管装置,其中,所述导线偏导器包括一个弯曲的导线偏导管,该偏导管具有一个位于所述导线通过孔处的近端,以及一个位于所述导管的导线腔中的远端,使得所述导线的近端被纳入所述弯曲的导线偏导管的远端,并且随后通过该弯曲的导线偏导管,并离开所述导线通过孔。
17.如权利要求16的栓子切除导管装置,其中,所述弯曲的导线偏导管的远端的直径大于该弯曲的导线偏导管的其余部分的直径,以便所述导线的近端进入该弯曲的导线偏导管的远端。
18.如权利要求16的栓子切除导管装置,其中,至少有一个支撑件连接在所述弯曲的导线偏导管的远端,以便使所述弯曲的导线偏导管的远端在导管的导线腔内保持在一个大体中央位置。
19.如权利要求17的栓子切除导管装置,其中,所述导线腔另外还延伸通过所述导管的靠近所述导线通过孔的部分,并被用于注入X光照相对照介质,并用于通过所述导线,并且,其中,在靠近所述弯曲的导线偏导管的远端处至少设有一个流动通道,以便X光照相对照介质能流过所述弯曲的导线偏导管并流出所述导管的远端。
20.如权利要求1的栓子切除导管装置,其中,所述导管体在靠近其远端处比靠近其近端处具有更大的柔性。
21.如权利要求20的栓子切除导管装置,其中,至少所述导管体的位于其近端和远端之间的一部分在其整个长度上具有逐渐增加的柔性。
22.如权利要求20的栓子切除导管装置,其中,所述导管体包括至少两个具有不同柔性的独立的部分。
23.如权利要求20的栓子切除导管装置,其中,所述导管体包括至少两个具有不同直径的独立的部分。
24.如权利要求23的栓子切除导管装置,其中,所述具有不同直径的独立的部分还具有不同的柔性。
25.如权利要求1的栓子切除导管装置,其中,所述障碍物捕获容器和导管体被构造成可通过皮下血管进入通道带着障碍物被抽出。
26.一种快速更换微型导管,包括:
一个长形的柔性导管,它具有一个近端和一个远端,所述导管在靠近其远端处比靠近其近端处具有更大的柔性;
一个纵向延伸通过该导管的腔;和
一个设在所述导管上靠近该导管远端一隔开距离处的导线通过孔,以便业已插入该导管腔远端的导线的近端可以从所述导线通过孔中出来,使得所述导线仅通过所述导管腔的一远端部分延伸。
27.如权利要求26的快速更换微型导管,还包括一个位于所述导管腔中的导线偏导器,它被设计成当所述导管沿远端方向在导线上进给时偏导所述导线的近端离开所述导线通过孔。
28.如权利要求27的快速更换导管装置,其中,所述导线偏导器包括一个弯曲的导线偏导管,该偏导管具有一个位于所述导线通过孔处的近端,以及一个位于所述导管的腔中的远端,以便所述导线的近端可以纳入所述弯曲的导线偏导管的远端,并且随后能通过该弯曲的导线偏导管,并离开所述导线通过孔。
29.如权利要求28的快速更换微型导管,其中,所述弯曲的导线偏导管的远端的直径大于该弯曲的导线偏导管的其余部分的直径,以便所述导线的近端进入该弯曲的导线偏导管的远端。
30.如权利要求28的快速更换微型导管装置,其中,至少有一个支撑件连接在所述弯曲的导线偏导管的远端,以便使所述弯曲的导线偏导管的远端在导管的导线腔内保持在一个大体中央的位置。
31.如权利要求30的快速更换微型导管装置,其中,所述导线腔延伸通过所述导管的靠近所述导线通过孔的部分,并被用于注入X光照相对照介质,并用于通过所述导线,并且,其中,在靠近所述弯曲的导线偏导管的远端处至少设有一个流动通道,以便X光照相对照介质能流过所述弯曲的导线偏导管并流出所述导管的远端。
32.如权利要求31的快速更换微型导管,其中,所述导管体包括至少两个具有不同柔性的独立的部分。
33.如权利要求32的快速更换微型导管,其中,所述导管体包括至少两个具有不同直径的独立的部分。
34.如权利要求33的快速更换微型导管,其中,所述具有不同直径的独立的部分还具有不同的柔性。
35.一种用于从哺乳动物患者的大脑的血管中取出诸如凝块的障碍物的系统,该系统包括:
一个导线,它有一个近端和一个远端;
一个微型导管,它包括一个长形的具有一个近端和一个远端的柔性管,所述管具有ⅰ)一个具有第一直径的近端部分,ⅱ)一个具有小于所述第一直径的第二直径的远端部分,ⅲ)一个通过所述管纵向延伸的腔;和
一个栓子切除导管装置,它包括ⅰ)一个长形的柔性栓子切除导管体,它具有一个近端,一个远端,以及一个至少通过其一部分纵向延伸的导线腔;和ⅱ)一个障碍物捕获容器,该容器最初呈径向收缩的状态,然后可展开成径向扩张的状态,其中,它有一个近端开口,通过该开口至少可将一部分障碍物纳入所述障碍物捕获容器;
所述导线、微型导管和栓子切除导管的相对大小和结构被确定为,可以通过包括以下步骤的方法取出所述障碍物:
A.将所述微型导管插入患者血管,并将该微型导管推进到靠近障碍物的位置;
B.在X光造影条件下通过所述微型导管腔注入X光照相对照介质,以便获得所述障碍物所在部位的血管的血管造影;
C.将所述导线推进到一理想的工作位置,其中,ⅰ)所述导线的远端业已至少部分穿过了所述障碍物;和ⅱ)所述导管的靠近其近端的部分保留在所述患者身体外部;
D.抽出并取出所述微型导管,同时抓住留在所述患者身体外部的导线部分,以防所述导线在抽出并取出所述微型导管期间经受明显的纵向回缩;
E.将所述导线的近端插入所述栓子切除导管的远端,使所述障碍物捕获容器处在其径向收缩的状态;
F.沿所述远端方向在所述导线上进给所述栓子切除导管装置,直到该栓子切除导管的远端业已至少部分穿过所述障碍物;
G.将所述障碍物捕获容器展开成其径向扩张的状态;
H.至少缩回所述障碍物捕获容器,以便导致所述障碍物的至少一部分通过其近端开口纳入所述障碍物捕获容器;和
I.抽出所述栓子切除导管装置和障碍物,以便从障碍物所沉积的位置上取出该障碍物。
36.如权利要求35的系统,其中,所述障碍物捕获容器和栓子切除导管体是这样构成的,即所述方法的步骤I可以通过经皮下穿孔通道抽出所述栓子切除导管装置和取出的障碍物而实现。
37.如权利要求35的系统,其中,所述栓子切除导管装置的障碍物捕获件具有一个在其中纵向延伸的导线通过孔,所述导线通过孔与所述栓子切除导管体的导线腔对齐,以便当所述栓子切除导管装置在所述方法的步骤F中沿远端方向推进时,所述导线会通过所述障碍物捕获容器的导线通过孔,并通过所述栓子切除导管体的导线腔。
38.如权利要求35的系统,其中,至少所述障碍物捕获容器的近端部分适用于在所述障碍物周围被抽拉,以便帮助所述障碍物捕获容器容纳该障碍物,所述障碍物捕获容器因此是这样构成的,即所述方法的步骤H可另外包括使得至少所述障碍物捕获容器的近端部分在所述障碍物的至少一部分被纳入所述障碍物捕获容器之后在所述障碍物周围被抽拉,以便帮助所述障碍物捕获容器容纳该障碍物。
39.如权利要求35的系统,其中,该系统还包括:
一个近端导管,通过该导管可以进给所述栓子切除导管装置,所述近端导管包括一个柔性管,该管具有一个通过它纵向延伸的腔,其中,所述近端导管的大小和结构是相对所述障碍物捕获容器设计的,以便所述方法的步骤I可以包括ⅰ)抽出所述栓子切除导管装置和障碍物,以便所述障碍物的至少一部分被纳入所述近端导管,然后ⅱ)抽出所述近端导管,同时抽出所述栓子切除导管装置,以便实现所述障碍物的取出。
40.如权利要求35的系统,其中,所述近端导管还包括一个近端障碍物接纳件,它可以从所述近端导管的远端展开,以便所述方法的步骤I还可以包括ⅰ)从所述近端导管上展开所述近端障碍物接纳件,和ⅱ)抽出所述栓子切除导管装置,以便所述障碍物被大体上捕获在所述障碍物捕获容器和所述近端障碍物接纳件之间。
41.如权利要求35的系统,其中,所述障碍物捕获容器包括ⅰ)一个远端障碍物容纳部分和ⅱ)至少一个近端支柱,当所述障碍物捕获容器展开成其工作的径向扩张状态时,该支柱在所述障碍物容纳部分和所述栓子切除导管体之间延伸,所述至少一个近端件的大小和结构适于通过所述障碍物,以便所述障碍物捕获容器在步骤H中回缩时,所述至少一个近端件能通过所述障碍物。
42.如权利要求35的系统,其中,所述栓子切除导管体包括至少两个具有不同柔性的独立的部分。
43.如权利要求35的系统,其中,所述栓子切除导管体包括至少两个具有不同直径的独立的部分。
44.如权利要求43的系统,其中,所述具有不同直径的独立的部分还具有不同的柔性。
45.如权利要求35的系统,其中,所述微型导管导管体包括至少两个具有不同柔性的独立的部分。
46.如权利要求35的系统,其中,所述微型导管导管体包括至少两个具有不同直径的独立的部分。
47.如权利要求46的系统,其中,所述具有不同直径的独立的部分还具有不同的柔性。
48.一种用于从位于哺乳动物患者大脑中或大脑周围的血管中取出阻碍血液流动的血液凝块或其他障碍物的方法,该方法包括以下步骤:
A.提供一种栓子切除导管装置,它包括ⅰ)一个具有一个近端和一个远端的长形的柔性栓子切除导管体,和ⅱ)一个障碍物捕获容器,它最初呈径向收缩的状态,然后展开成径向扩张的状态,其中,它具有一个近端开口,所述障碍物的一部分可以通过该开口纳入所述障碍物捕获容器,ⅲ)一个导线腔,它延伸通过所述障碍物捕获容器,并通过所述栓子切除导管体的至少一部分;
B.提供一具有一个近端和一个远端的导线,该导线的大小适于皮下插入患者的血管,然后通过血管推进到导线工作位置,在这里,所述导线的远端业已至少部分穿过了所沉积的血液障碍物;
C.皮下插入所述导线,并将该导线推进到所述导线工作位置;
D.将所述导线纳入所述栓子切除导管装置的导线腔,并将该栓子切除导管装置沿所述导线推进,直到该栓子切除导管体的远端通过所沉积的障碍物;
E.将所述障碍物捕获容器展开成其径向扩张状态;
F.沿近端方向退回至少所述障碍物捕获容器,以便导致所述障碍物的至少一部分被纳入所述障碍物捕获容器。和
G.抽出所述栓子切除导管装置、所述导线和所述障碍物,以便恢复所述障碍物曾经沉积部位的血管的血液流动。
49.如权利要求48的方法,其中,在步骤C之前该方法还包括:
在X光造影观察条件下注入第一种量的X光照相对照介质,以便通过X光造影确定所述障碍物目前所在的部位。
50.如权利要求49的方法,其中,所述第一种量的X光照相对照介质是通过一个独立的微型导管注入的,并且,其中,所述方法在步骤D之前还包括以下附加步骤:
提供一个微型导管,它包括一个具有一个近端和一个远端的长形柔性管,所述管具有ⅰ)一个具有第一直径的近端部分,ⅱ)一个具有小于所述第一直径的第二直径的远端部分,ⅲ)至少一个沿该管纵向延伸的腔;
使得所述导线被纳入所述微型导管的腔,并推进该微型导管和导线,直到所述微型导管的远端位于被认为是所述障碍物沉积的部位附近;
在X光造影观察条件下通过所述微型导管的腔注入第一种量的X光照相对照介质,以便通过X光造影确定所述障碍物目前所在的部位;
通过所述微型导管进一步推进所述导线,直到该导线达到导线工作位置,在这里,其远端已经至少部分穿过了所述障碍物;
将所述导线保持在所述导线工作位置上,同时从患者体内抽出所述微型导管,以及,然后,
实施所述方法的步骤D-G。
51.如权利要求48的方法,其中,所述微型导管是快速更换微型导管,它还包括:
设在接近所述导管远端的一隔开距离处与所述微型导管腔连通的导线通过孔,其中,所述将导线纳入所述微型导管腔的步骤还包括使得所述导线的近端从所述导线通过孔中出来,以便所述导线仅延伸通过所述微型导管腔的远端部分,以及,其中,
所述导线包括一个非交换长度的导线。
52.如权利要求48的方法,其中,所述栓子切除导管装置的障碍物捕获容器包括一个远端障碍物容纳部分,它具有一个近端开口,以及至少一个近端支柱件,该件在所述栓子切除导管体和所述容器的远端障碍物容纳部分之间延伸,其中,所述方法的步骤F还包括:
至少将所述障碍物捕获容器沿近端方向退回,以便其至少一个近端连接件通过所述障碍物,并且所述障碍物的至少一部分被纳入其远端障碍物捕获部分。
53.如权利要求48的方法,其中,步骤H是通过经一个皮下血管进入通道抽出所述栓子切除导管装置和所取出的障碍物而实现的。
54.如权利要求53的方法,其中,所述栓子切除导管是通过一个皮下血管进入通道插入所述栓子切除导管,其中,所述步骤H是通过经插入该栓子切除导管的相同的皮下血管进入通道抽出所述栓子切除导管装置和所取出的障碍物而实现的。
55.一种用于从血管中取出血液凝块或其他障碍物的栓子切除导管装置,该装置包括:
一个长形柔性导管体,它具有一个近端,一个远端,以及一个至少通过其一部分纵向延伸的导线腔;
一个障碍物捕获容器,它最初呈第一种收缩的状态,在这种状态下可以通过所述障碍物,以及随后展开成第二种径向扩张的状态;
所述障碍物捕获容器包括一个远端障碍物容纳部分,以及至少一个近端支柱,该支柱从所述导管体延伸到所述容器的远端障碍物接纳部分;
所述至少一个近端支柱被设计成当沿近端方向退回时能通过一血液凝块。
56.如权利要求55的栓子切除导管装置,其中,所述障碍物捕获容器是足够地多孔的,以便血液可以通过它流动,但又是足够地非多孔的,以便阻止血液凝块从中通过。
57.如权利要求56的栓子切除导管装置,其中,所述障碍物捕获容器上设有100-1000微米的开口,以便提供25%-90%的孔隙度。
58.如权利要求55的栓子切除导管装置,其中,所述障碍物捕获容器至少部分是由预先成型的、弹性材料制成,它在退入所述导管中时收缩成所述第一种形状,并且在推进离开所述导管时扩张成所述第二种形状。
59.如权利要求58的栓子切除导管,其中,所述障碍物捕获容器至少部分地是由一种在体温下具有超弹性的材料制成。
60.如权利要求59的栓子切除导管装置,其中,所述障碍物捕获容器是由在体温下具有超弹性的镍-钛合金制成。
61.如权利要求55的栓子切除导管装置,其中:
所述导管还包括若干延伸通过该导管的远端的件导向通道;
所述障碍物捕获容器包括若干具有远端部分的长形件,所述长形件是预先成型的,以便确保所述容器的远端障碍物容纳部分的形状,以及构成所述至少一个支柱的近端部分,所述长形件延伸通过设在所述导管远端的导向通道;
所述长形件可沿近端方向通过所述导向通道退出,以便能形成大体上直的形状;和
所述长形件可沿远端方向通过所述导向通道推进,以便形成所述远端障碍物容纳部分和所述至少一个近端支柱。
62.如权利要求55的栓子切除导管装置,还包括一个设在所述长形的远端的顶端件,所述容器的导线腔延伸通过所述顶端件。
63.如权利要求55的栓子切除导管装置,还包括:
一个设在所述导管体的近端上的近端连接件,所述近端连接件具有一个设在它上面的注入口,以便能通过导管体的腔注入X光照相对照介质,同时将一个导线放置在所述导管体的导线腔内。
64.如权利要求55的栓子切除导管装置,其中,所述支柱被构造和定位成当沿近端方向抽出时它可以通过血液凝块,不过所述容器的远端障碍物容纳部分具有足够的密度,以便阻止凝块从中通过。
65.如权利要求55的栓子切除导管的位于导线上的实施方案,其中,所述导线腔纵向延伸通过大体整个导管体。
66.如权利要求55的栓子切除导管的快速更换实施方案,其中,所述导管还包括一个设在该导管上靠近该导管远端的一隔开距离处的导线通过孔,并且其中,所述导线腔在所述导管中至少从所述导线通过孔延伸到所述导管的远端。
67.如权利要求66的栓子切除导管装置,还包括一个位于所述导线腔中的导线偏导器,其被设计成当所述导管沿远端方向在导线上推进时偏导所述导线的近端离开所述导线通过孔。
68.如权利要求67的栓子切除导管装置,其中,所述导线偏导器包括一个弯曲的导线偏导管,该偏导管具有一个位于所述导线通过孔处的近端,以及一个位于所述导管的导线腔中的远端,这样所述导线的近端将被纳入所述弯曲的导线偏导管的远端,并且随后将通过该弯曲的导线偏导管,并离开所述导线通过孔。
69.如权利要求68的栓子切除导管装置,其中,所述弯曲的导线偏导管的远端的直径大于该弯曲的导线偏导管的其余部分的直径,以便所述导线的近端进入该弯曲的导线偏导管的远端。
70.如权利要求68的栓子切除导管装置,其中,至少有一个支撑件连接在所述弯曲的导线偏导管的远端,以便将所述弯曲的导线偏导管的远端保持在导管的导线腔内的一个大体中央位置。
71.如权利要求66的栓子切除导管装置,其中,所述导线腔另外还延伸通过所述导管的靠近所述导线通过孔的部分,并被用于注入X光照相对照介质,并用于通过所述导线,并且其中,在靠近所述弯曲的导线偏导管的远端处至少设有一个流体通道,以便X光照相对照介质能流过所述弯曲的导线偏导管并流出所述导管的远端。
72.如权利要求55的栓子切除导管装置,其中,所述导管体在靠近其远端处的柔性大于靠近其近端处的弹性。
73.如权利要求72的栓子切除导管装置,其中,所述导管体在其近端和远端的至少一部分上在其整个长度上具有逐渐增加的柔性。
74.如权利要求72的栓子切除导管装置,其中,所述导管体包括至少两个具有不同柔性的独立的部分。
75.如权利要求72的栓子切除导管装置,其中,所述导管体包括至少两个具有不同直径的独立的部分。
76.如权利要求75的栓子切除导管装置,其中,所述具有不同直径的独立的部分还具有不同的柔性。
77.如权利要求55的栓子切除导管装置,其中,所述障碍物捕获容器和导管体被构造成通过皮下血管进入通道可带着障碍物被抽出。
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JP2002513646A (ja) | 2002-05-14 |
US20100145371A1 (en) | 2010-06-10 |
EP1949921B1 (en) | 2013-11-06 |
US20140135803A9 (en) | 2014-05-15 |
DE69938425D1 (de) | 2008-05-08 |
CN1203811C (zh) | 2005-06-01 |
EP1079874A4 (en) | 2004-12-29 |
US7691121B2 (en) | 2010-04-06 |
US20140257245A1 (en) | 2014-09-11 |
WO1999056801A3 (en) | 2000-04-06 |
US20080015541A1 (en) | 2008-01-17 |
EP1079874A2 (en) | 2001-03-07 |
EP1079874B1 (en) | 2008-03-26 |
ES2430352T3 (es) | 2013-11-20 |
US20040133232A1 (en) | 2004-07-08 |
JP4219558B2 (ja) | 2009-02-04 |
EP2335748B1 (en) | 2013-07-10 |
AU767873B2 (en) | 2003-11-27 |
WO1999056801A2 (en) | 1999-11-11 |
ATE390154T1 (de) | 2008-04-15 |
EP2335748A1 (en) | 2011-06-22 |
US6511492B1 (en) | 2003-01-28 |
US8784441B2 (en) | 2014-07-22 |
DE69938425T2 (de) | 2009-01-02 |
BR9910169A (pt) | 2002-12-31 |
ES2440723T3 (es) | 2014-01-30 |
ES2304808T3 (es) | 2008-10-16 |
US6685722B1 (en) | 2004-02-03 |
US8100935B2 (en) | 2012-01-24 |
EP1949921A3 (en) | 2008-08-06 |
CA2329013A1 (en) | 1999-11-11 |
AU3780199A (en) | 1999-11-23 |
EP1949921A2 (en) | 2008-07-30 |
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