CN103549986A - 可去除的结合的血栓装置团块和可扩张装置的用途 - Google Patents
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Abstract
本发明公开了可去除的结合的血栓装置团块和可扩张装置的用途。利用具有自扩张的远侧段的装置在闭塞血管中恢复血流,所述装置被预成型以采取处于不受约束的状态下的重叠结构,但可以制成采取体积缩小形式,这使得能够使用微导管和布置在近端的推送导线将其引入,处于其重叠结构的远侧段采取纵向开口管的形式并具有相互连接的线或细丝或支柱的网状结构。在优选的实施方案中,所述远侧段在其近端具有锥形结构,其中线或细丝或支柱在连接点处会聚。
Description
本申请是名称为“用于去除血栓的自扩张装置和可去除的结合血栓的装置”、国际申请日为2009年2月20日、国际申请号为PCT/US2009/034774、国家申请号为200980113994.5的发明专利申请的分案申请。
技术领域
本发明涉及用于快速或立即恢复闭塞的血管中,特别是闭塞的脑动脉中血流的方法和装置。此外,本发明涉及所述装置用于血栓去除和/或血栓溶解的应用。
背景技术
目前用于处理由血栓闭塞的脑动脉的技术可能要花费数小时重建动脉中的血流。此外,已知的处理脑血栓的装置和方法对溶解血栓可能无效或仅部分有效,且可以另外导致末梢栓塞或未累及动脉的栓塞。永久性神经性缺乏的风险和程度随由症状发作到血流恢复的时间增长而迅速增大。
发明内容
本发明涉及在由血栓闭塞的血管部位中恢复局部血流的方法。预期本发明的方法提高由血栓闭塞的脑血管的血管重建的速度和效率。
在一个实施方案中,提供这样的方法和装置,其在所述装置展开寸在闭塞的动脉中立即建立(或恢复)血流。在一方面,将自扩张装置递送至与血栓径向靠近的部位且该装置在该处扩张,从而恢复血流。
在另一个实施方案中,本发明涉及在由血栓闭塞的血管中恢复血流的方法和装置,其具有相关增加的从血管中移除血栓和去除血栓的效率。在该实施方案中,将自扩张装置递送至与血栓径向靠近的部位并然后扩张。扩张的装置再恢复血流,该血流帮助从血管壁移除血栓。在一个实施方案中,所述装置与血栓接合并且然后血栓可以由闭塞部位去除。
在另一个实施方案中,本发明涉及在闭塞动脉中恢复血流的方法和装置,其具有相关增加的从血管中溶解部分或全部血栓的效率和任选地收回该装置。在该实施方案中,将自扩张装置递送至与血栓径向靠近的部位并然后扩张。一旦扩张,该装置则恢复闭塞部位的血流并且该增加的血流可以溶解或部分或基本溶解血栓,然后装置-血栓团块从先前的闭塞部位被去除。
在另一个实施方案中,本发明涉及在闭塞动脉中恢复血流的方法和装置,其具有相关增加的从血管中溶解部分或全部血栓的效率和植入该装置的一部分。在该实施方案中,该装置与血栓的至少一部分接合(或植入或结合成一体),从而提供可去除的、结合的装置-血栓团块。该可去除的、结合的装置-血栓从闭塞部位去除。
在一些实施方案中,本发明的方法涉及对血栓闭塞的血管中的血流恢复进行成像的方法。该方法包括:a)获得置于与血栓径向靠近的自扩张装置的图像;和b)获得扩张所述装置以恢复血流的图像。
在另一个实施方案中,本发明的方法涉及对部分或基本溶解嵌在血管中的血栓进行成像的方法。该方法包括:a)获得置于与血栓径向靠近的自扩张装置的图像;和b)获得扩张所述装置以增加通过血管的血液的图像,其中增加的血流部分或基本溶解血栓。
在另一个实施方案中,本发明的方法对移除嵌在血管中的血栓进行成像的方法。该方法包括:a)获得置于与血栓径向靠近的自扩张装置的图像;b)获得扩张所述装置从而与血栓的至少一部分接合的图像;和c)获得向远端或近端移动该装置由此移除血栓的图像。
预期许多自扩张装置有效用于本发明的方法。在一个实施方案中,该装置是可反转的自扩张装置。在另一个实施方案中,该装置是全部可收回的或可缩回的。在一个实施方案中,自扩张装置包括包括第一组多个网格的网状结构,所述网状结构具有近端和远端;包括第二组多个网格的锥形部,所述锥形部朝向网状结构的近端布置;和连接点,所述锥形部会聚在所述连接点处,所述连接点位于锥形部的近端,其中该装置被预成型以采取体积扩大形式且,在该体积扩大形式中,其采用朝向连接点渐细的纵向开口管的形式。
本发明的另一个实施方案是用于去除血管中血栓的自扩张装置,其包括:包括第一组多个网格的网状结构,所述网状结构具有近端和远端,其中所述网状结构的远端被配置为与血栓的至少一部分接合,从而形成可去除的、结合的装置-血栓团块;包括第二组多个网格的锥形部,所述锥形部朝向网状结构的近端布置;和连接点,所述锥形部会聚在所述连接点处,所述连接点位于锥形部的近端,其中该装置被预成型以采取体积扩大形式且,在该体积扩大形式中,其采用朝向连接点渐细的纵向开口管的形式。
预期所述网状结构的远端被配置为通过对网状结构提供增大的支撑和通过增加血栓滞留而帮助取出血栓。
在本发明的另一个实施方案中,提供可去除的、结合的装置-血栓团块,其包括与装置至少部分接合的血栓,其中所述装置包括网状结构,其包括第一组多个网格,且具有近端和远端,其中所述网状结构的远端被配置为与血栓的至少一部分接合;包括第二组多个网格的锥形部,所述锥形部朝向网状结构的近端布置;和连接点,所述锥形部会聚在所述连接点处,所述连接点位于锥形部的近端,其中该装置被预成型以采取体积扩大形式且,在该体积扩大形式中,其采用朝向连接点渐细的纵向开口管的形式。
因此,根据本发明,提供了一种可去除的结合的血栓装置团块,包括与装置至少部分接合的血栓,其中所述装置包括:
包括第一组多个格子的结构,所述结构具有近端和远端,所述近端和所述远端为开口的,并且所述第一组多个格子被配置为与所述血栓的至少一部分接合;
包括第二组多个格子的锥形部,所述锥形部朝向所述结构的近端布置;和
连接点,所述锥形部会聚在所述连接点处,所述连接点位于所述锥形部的近端,
其中所述自扩张装置被预成型以采取体积扩大形式且,在所述体积扩大形式中,其采用朝向所述连接点渐细的纵向开口管的形式。
可选地,所述结构的远端包括具有螺旋或孔眼形状的不透射线标记物。
可选地,所述结构的远端处于体积扩大形式时具有比处于所述体积扩大形式的结构的近端更大的直径。
可选地,所述结构的远端包括一个或多个桩和/或钩。
可选地,所述结构的远端包括纤维。
可选地,对所述结构的远端加热足够的时间,从而提供增加的径向强度。
可选地,所述结构涂覆有抗凝血剂或抗血小板药。
可选地,所述结构还涂覆有可生物降解的生物相容的聚合物,以提供抗凝血剂或抗血小板药的持续释放。
可选地,所述结构包括用于容纳凝血剂或抗血小板药的储库。
根据本发明,还提供了一种可扩张装置用于从动脉内处理和去除血栓的用途,其中所述装置包括:
包括第一组多个格子的结构,所述结构具有近端和远端,所述近端和所述远端为开口的,所述结构的远端被配置为与所述血栓的至少一部分接合,从而形成可去除的、结合的装置-血栓团块;
包括第二组多个格子的锥形部,所述锥形部朝向所述结构的近端布置;和
连接点,所述锥形部会聚在所述连接点处,所述连接点位于所述锥形部的近端,
其中所述自扩张装置被预成型以采取体积扩大形式且,在所述体积扩大形式中,其采用朝向所述连接点渐细的纵向开口管的形式。
可选地,所述结构的远端包括具有螺旋或孔眼形状的不透射线标记物。
可选地,所述结构的远端处于体积扩大形式时具有比处于所述体积扩大形式的结构的近端更大的直径。
可选地,所述结构包括在近侧部处的第一组多个格子、在锥形部处的第二组多个格子,且其中所述结构的远端包括第三组多个格子且其中所述第三组多个格子具有比所述第二组多个格子更小的格子尺寸。
可选地,所述结构的远端包括一个或多个桩和/或钩。
可选地,所述结构的远端包括纤维。
可选地,对所述结构的远端加热足够的时间,从而提供增加的径向强度。
可选地,所述结构涂覆有抗凝血剂或抗血小板药。
可选地,中所述结构还涂覆有可生物降解的生物相容的聚合物,以提供抗凝血剂或抗血小板药的持续释放。
可选地,所述结构包括用于容纳凝血剂或抗血小板药的储库。。
附图说明
结合在本文中并构成该说明书一部分的附图图解本发明的示范性实施方案,并与以上提供的概括说明和以下提供的详细说明一起,用来解释本发明的特征。
图1显示有效用于本发明的方法的装置。
图2a显示待通过本发明处理的靶闭塞或血栓。
图2b、3和4显示根据本发明的放置方法。图3以虚构的微导管8显示。
图5显示根据本发明的血栓移除和松动。
图6和7显示根据本发明的血栓溶解法。
图8和9显示根据本发明的装置收回方法,其使用以虚构显示的微导管。
图10、11和12显示根据本发明的装置植入法。
图13是根据本发明一个实施方案的装置,其具有蜂窝结构。
图14是根据本发明的支架的另一个实施方案,其具有蜂窝结构。
图15是根据本发明的支架的第三种实施方案,其具有蜂窝结构。
图16作为可以用于根据本发明的装置的经编结构。
图17a和图17b是根据本发明一个实施方案的装置的图示,该装置以其重叠和以其体积缩小(volume-reduced)形状显示。
图18a、图18b、图18c、图18d和图18e是可以用于根据本发明的装置的最远侧段的实施方案,它们包括标记元件。
图19a和图19b是两个拆卸位置的图示,根据本发明的装置可以通过该拆卸位置与导丝(guide wire)可拆卸地连接。
具体实施方式
除非另外定义,本文中使用的全部技术和科学术语具有与本发明所属领域中的一般技术人员通常理解的相同的含义。尽管与本文中所述的那些相似或等同的任何方法和材料可以用于实施或测试本发明,但是现在描述优选的方法、装置、和材料。本文中引用的全部出版物和专利申请通常引用整体结合与此。本文中没有任何内容可以被解释为承认本发明无权通过在先发明而早于本公开内容的日期获得授权。
必须注意,用于本文中和所附权利要求中时,单数形式“一个”“某个”和“该”包括复数指代物,除非上下文另外清楚地规定。
方法
本发明涉及对闭塞血管部位恢复局部血流的方法。血管部位、或血管可以由血栓闭塞。本发明方法中使用的装置可以用微导管和任选地用导引导管定位在血管部位处。本发明的方法可以使用完全可收回的装置,这是对现有技术的改进,现有技术方法需要将装置永久性植入患者体内。当将装置永久性置于患者体内时,需要对患者进行终身的抗凝治疗。因此,预期通过使用可收回的装置,可以避免终身的抗凝治疗。
提供方法和装置,以恢复被血栓12闭塞的脑动脉11中的血流(图2a)。该方法使用具有自扩张、任选可反转的自扩张的远侧段1的装置,所述远侧段1包括远端2、近端3、和主体部4,该装置被预成型以采取处于不受约束的状态下的重叠结构5但可以被制成具有体积缩小形式6,这使其可能用推送导线(push wire)7引入,所述推送导线7连接在近端3和微导管8处,远侧段1处于其重叠结构5,其采取纵向开放管形式并具有相互连接的线或细丝或支柱的网状结构(图1和3)。在一个实施方案中,远侧段1在其近端3处具有锥形结构,其中所述线或细丝或支柱会聚在连接点9。推送导线7优选连接在或邻近连接点9处。所述连接10可以是永久的或可拆卸的机构。本文中所述的方法可以采用美国专利7,300,458中所述的医疗远侧段1(或装置或支架,关于其的全部术语可交换使用)进行,该专利整体结合于此。
根据本发明,通过用推送导线7将其在微导管8中推进,将装置的自扩张远侧段1以体积缩小形式6定位在被血栓12闭塞的血管11内,以使其近端3在血栓的上游,其远端2在血栓的下游且具主体部4的位置径向地靠近血栓12(图1和3)。如图3中所示,远侧段1的远端2被定位在远侧血栓边界的远侧且远侧段的近端3被定位在近侧血栓边界的近侧。远侧段1通过保持推送导线7静止而保持在固定的位置,而远侧段1通过在远侧段1的近侧抽出微导管8而从其体积缩小形式6松开(图4)。远侧段1使其重叠结构5的至少一部分处于不受约束的状态下13,由此扩张以使得至少一部分主体部穿透接触血栓12’,对血栓12’施加向外的径向力,减小血栓12’的横截面面积,并立即重建越过血栓12’通过血管11的血流14。
本发明还预期将有效量的血块清除剂(clot-busting drug),诸如,例如组织型纤溶酶原激活物(tPA)施用于血栓部位。该药物的施用应该起进一步增强凝块溶解的作用。
这种放置方法扩大了适合于要求血管内空间在微导管所到达之处的远侧的装置治疗的患者群体,因为本发明的方法将远侧段1放置在超过血栓12的远端处。另外,这种放置方法扩大可以成功实践本方法的医师群体,因为其利用使用者已经熟悉的微导管技术递送并促进装置的快速放置。立即恢复血流14与用于治疗被血栓12闭塞的脑动脉11的已知装置和方法相比具有显著的优势,因为已知的装置和方法可能需要数小时来重建血流14,且明确永久性神经性缺乏风险和程度随由症状开始至血流恢复的时间增长而迅速增加。
在一个实施方案中,提供恢复闭塞的动脉11中血流的血栓去除方法和装置,其从血管中移除血栓12’并从患者去除血栓12’和装置的效率增高。在优选的实施方案中,恢复闭塞的动脉11中的血流14包括放置微导管8,以使得微导管远侧尖端16超过血栓12的远端,其中远侧尖端16超过血栓12的远端大于约0毫米(mm)-约10mm以上,或约3mm-约5mm(图2b)。自扩张远侧段1在微导管8内,以其减小的体积形式6,被推送导线7推进,直至其远端2刚好超过血栓12的远端(图3)。
正确放置的可视化可以通过X线透视检查完成。具体地,这可以通过将远侧段的远端上的不透射线标记物15与远侧不透射线微导管标记物17对准(图3)。如上提及地,本发明还涉及多种获得该过程的图像的方法。典型使用的成像法是X线透视检查(其可以确认装置的正确放置)或对比剂注射(其可以确认血流恢复)。然而,还预期本领域中技术人员已知的许多成像法。
然后通过保持推送导线7固定,同时向近侧抽出微导管8,在血栓12’内和跨过血栓12’展开远侧段1,直至远侧段1松开13(图4)。完全展开的一个指示是由临床医师看到分辨远侧段1的近端3的不透射线标记物18与远侧不透射线微导管标记物17对准,或在其远侧。备选地,微导管8可以完全从患者中去除。当远侧段1展开13时,立即恢复跨过血栓12’的血流14并可以通过对比剂注射而可视化地确认。这是相对于血栓12’和血管解剖学的正确的远侧段位置的指示。
所述装置可以在以下之一后用于去除血栓12’:远侧段1展开13后经过的固定时间量,其可以是约0分钟-约120分钟以上;观察到跨过血栓12’的血流14停止;已经经过预定的最大流动时间量,无论哪种首先发生。
去除血栓12’可以通过许多变型来实现(图5)。例如,当体积缩小形式6的远侧尖端移动超过血栓时,其与如图5中所示的接合血栓的那个部分相比,会遭遇较小的扩张抵抗力并提供更大的径向力。因此,远侧尖端2可以超过血栓12’扩张,从而形成直径大于被血栓的至少一部分接合的远侧段的直径的远侧尖端2。在一些实施方案中,这可以是钩状远侧构型。另一种结构变化记述如下,其可以用于进一步协助血栓接合和去除。利用推送导线7,展开的远侧段13的拉力19会使血栓缩回至导管,因为该钩状构型起勾住血栓的作用。随后去除导管将导致血栓从闭塞部位的去除。
在将所述装置拉回前,可以以以下任一方式操作微导管8:远侧不透射线微导管标记物17可以保持在远侧段近侧不透射线标记物18处或其近侧或完全从患者中去除;微导管8可以相对于远侧段1向前移动至预定点,其可以是:当远侧不透射线微导管标记物17理想地与近侧不透射线标记物18的远侧段对准时;当远侧不透射线微导管标记物17理想地与近侧不透射线标记物18的远侧段的远侧对准时,为例如约0.5mm-约10mm或约5mm-约10mm;当通过微导管8的弯折证实微导管8推进遭遇到显著抵抗力时;或所需的对准或显著抵抗力中无论哪种首先发生。当使展开的远侧段13朝向导引导管移动或移动进入导引导管时,可以发生以下任一项:近侧导引腔与气囊(pressurebag)或其正压流体源连通;近端导引腔与大气连通;或近侧导引腔与抽气源或其他负压连通。
本发明的血栓去除方法具有超越已知血栓去除方法的独特优势。当跨过血栓展开时,远侧段1通过构建跨血栓12’的流体通道而形成术中血流14(图4)。这样,远侧段13显著减小跨血栓12’的压降,并且因此显著地减小压力相关的力,该力否则会抵抗血栓12的去除(图5)。此外,流体通路通过展开的远侧段13将血栓12’圆周的大部分与管壁分离而形成。另外,体积缩小形式6的扩张形成结合成一体的团块,其中网包埋在血栓内。如上,体积缩小形式6的远侧段可以产生更大的径向力(且在扩张时可以处于钩状构型),由此促进血栓的去除。
估计在远侧段1展开13后,初始血栓12圆周的约10%-约60%与管壁分离,且展开后血栓12’通过粘附力和摩擦力附着于管壁上的能力因此而减小。此外,初始血栓12的横截面面积被展开的远侧段13显著减小,由此导致血栓12’具有其初始横截面面积的约30%-约95%,但是更典型地其初始横截面面积的约50%-约80%。全部这些导致更有效的血管重建术,这归因于较小的血栓移除和松动力和更有效的血栓松动19,如通过本文中稍后描述的函数来证明。在其他益处中,较小的血栓松动力沿着血栓12’全长分布,或至少沿着远侧段13的全长分布,由此减小所述装置滑动经过或穿过血栓或分裂血栓的机会,这种机会可以导致残留的血栓,末梢栓塞,或未累及区域的栓塞。
靶闭塞由具有横截面面积A的初始血栓12表示(图2a),从而形成相关的跨血栓压降P,具有圆周血管接触面积C,和f是与血栓粘附力和摩擦力/接触面积比成比例的量。通过不构建跨血栓的术中血流和不将大部分血栓圆周与管壁分离的已知方法移除或松动该血栓所需的力可以通过以下函数描述:
(A*P)+C*f
对于本发明的血栓去除方法,即当远侧段1在血栓12’内展开13时(图4),血栓12’具有减小的横截面面积“a”,其中a<A,减小的跨血栓压降“p”,其中p<P,显著减小的圆周血管接触面积“c”,其中c<C,且f是与血栓粘附力和摩擦力/接触面积比成比例的量。按照本文中所述的方法移除和松动该血栓12’所需的力显著低于通过已知方法移除和松动初始血栓12所需的力(图5),并可以通过以下函数描述:
(a*p)+c*f
木发明还预期恢复闭塞的动脉中的血流14的血栓溶解方法和装置,其具有增高的从血管中溶解部分(图7)或全部(图6)血栓和收回所述装置的效率(图8和9)。如前所述,远侧段在血栓12’内和跨血栓12’展开,以恢复闭塞的动脉中的血流14(图4)。立即重建血流14是超越用于治疗被血栓闭塞的脑动脉的已知装置和方法的显著优势,因为已知装置和方法可能需要数小时来重建血流。特别的益处包括在初始闭塞的远侧重建前向性血流,以灌注缺血性组织和有助于分解初始闭塞远侧可能存在的栓子。另外的益处源自增加暴露于血流的血栓12’的表面积,由此提高血液对血栓12’的天然溶解作用的功效并提高由医师引入的溶解血栓剂、抗凝血剂、抗血小板剂、或其药剂的功效,全部这些促进血栓溶解。当血栓已经被完全溶解(图6),或充分减小12”以至于不可能再闭塞(图7)时,通过使微导管8沿整个远侧段1前进同时将推送导线7保持在固定位置来收回远侧段1,这样远侧段1不在动脉内轴向移动(图8和9)。所述装置可以随后通过微导管8去除,或备选地可以去除微导管8,装置的远侧段1仍然在其内部。
另外,预期本发明的方法可以恢复闭塞的动脉中的血流,其具有增高的从血管中溶解部分或全部血栓并植入远侧段1的效率。包括植入远侧段1的方法需要使用在远侧段1和推送导线7之间具有可拆卸的连接机构的装置。如前所述,远侧段1在血栓12’内和跨13血栓12’展开,以恢复闭塞的动脉中的血流14(图4)。远侧段1可以然后通过可拆卸的连接机构从推送导线卸除。当血栓12’已经充分减小以使得不可能再闭塞时(图11),或当血栓完全溶解时(图12),该卸除可以在重建血流时立即发生。
在本发明的另一个实施方案中,通过抽吸微导管和/或导引导管辅助血栓去除或溶解。
源自远侧段和推送导线之间的可拆卸机构的效用包括一种装置对本文中公开的全部方法的适用性,从而为使用者提供程序上的选择。在其他益处中,如果确定不可能由患者中去除,则可拆卸机构容许使用者卸除不受约束的远侧段。
本发明的某些实施方案包括恢复血流和然后卸下装置和将装置保持在原位的方法(图12)。这可以在临床医师确定任一装置不再可收回时进行。在该实施方案中,预期所述装置应该是用抗凝血剂或抗血小板药涂覆或否则包埋的。这在下文中更详细地讨论。
装置
如上所述,通过本发明的方法可以使用任何合适的自扩张装置。所述装置的多种实施方案可以参见美国专利7,300,458,通过引用将其整体结合于此。
远侧段1,根据图3,由网或蜂窝结构组成,其在一个实施方案中,包括通过激光焊技术相互连接的许多细丝。远侧段1可以再分为功能结构A和锥形近侧结构B,两个结构是可通过不同的网格尺寸彼此区分。为了使功能结构A执行其功能,保持其网格23相对窄,以使得它们自身适合于植入血栓12内。一般地,网格宽度在0.5-4mm范围内且可以在该段内变化。
在本发明的一方面,远侧段1是扁平的或二维结构,其卷起以形成纵向开放的物体,该物体能够构建与将其引入的血管壁的紧密接触。
在远侧段1的锥形近侧结构B中,提供较宽的网格24结构,其已经为了达到具有最小扩张效果而被最优化。在锥形结构22的区域内,细丝具有更大的厚度和/或宽度,从而能够在将远侧段1引入并置于适当位置时,更好地将在连接点9处施加的导丝推力和拉力传递至功能结构A。在锥形结构的区域内,通常不需要提供对管壁的支持和管壁覆盖,但是另一方面如对抗张强度和推力强度的要求增加。功能结构A中的细丝厚度通常在0.02-0.076mm范围内,且在近侧结构部分B中,细丝厚度大于0.076mm。
近侧结构在连接点9处形成45度-120度的角,特别地约90度的角。细丝厚度(或线宽度)与网格尺寸相同,且其形状可以大范围变化以适合如对稳定性、灵活性等的不同需要。理解近侧结构B也接触管壁并因此不干扰血管内的血液流动。
在远端处,细丝22的末端为一系列尾状物2,所述尾状物是携带铂标记物的合适类型,铂标记物有助于远侧段1的定位。
远侧段1以这样的方式卷起,即边缘27和28彼此至少靠近地定位,且可以在边缘区域内重叠。在该体积缩小形式中,远侧段1,与金属丝网卷类似,已经卷起至这样的程度,即由此形成的卷可以引入微导管中并在该导管中移动。在从微导管中卸除后,卷起的结构弹开并试图采取先前压盖于其上的重叠结构且在这样做时紧靠向待治疗的血管的内壁,由此浅表地覆盖血栓并然后植入该位置处存在的血栓中。在该情形中,“卷起”的程度由血管体积决定。在较窄的血管中,将发生远侧段1的边缘27和28的较大重叠,而在较宽的血管中,重叠会较小或甚至会遭遇“负重叠”,且必须进行合理的注意以确保远侧段1仍表现出残余张力。
可以用于所述装置的合适材料包括具有形状记忆特性的合金。成品在通常应用该材料的温度下进行回火处理,从而永久性构建压印的结构。
远侧段1具有网状结构,其由彼此连接的线或细丝组成。如果远侧段1包括切割结构如,例如冠状动脉支架中常用的那些则存在线,如果远侧段1以具有针织(knitted)或编织(braided)的结构的垫子形式或以彼此焊接的单丝形式存在,则存在由细丝组成的网状结构。
图14显示按照本发明的具有上述蜂窝结构的远侧段1的另一种实施方案,其中锥形近侧结构B与功能结构部分A通过外周区域30中以及中心区域中的附加细丝29连接。附加细丝29和30致使拉力和推力从近侧结构B到功能结构A的更均匀的传输。结果,拉力可以更好地传输,特别是如果支架由于需要缩回到微导管中可能需要再定位。附加细丝29、30促进支架的重新卷起。类似地,当将支架移出和置于合适位置时发生的推力的传输得到促进,因此可以轻轻地应用支架。
图15显示按照本发明的具有述蜂窝结构的远侧段1的另一种实施方案,所述蜂窝结构具有由直的细丝29形成的边缘27和28。根据该实施方案,连接点29处由导丝施加的推力或压力直接传输到功能结构部分A的边缘27和28,这进一步增加参考图14所述的效果。
参照图15的实施方案,类似于图13和14中所述的那些,可以基于切割箔,即单丝22,29和30被单线代替,所述单线是在切割技术帮助下加工的箔的剩余元件。已知用于生产具有管状结构的支架的激光切割技术。类似地进行对箔的加工,以生产适合于支架的图案。重叠结构的压印以与用于细丝设汁相同的方式进行。
在一个实施方案中,扩张的金属箔可以以处于相同数量级的各种线宽度使用。在一个实施方案中,预想随后使该箔变平滑,以确保所有的线被配置在相同平面上。箔的厚度通常在0.02-0.2mm范围内。较厚的箔也允许支架用在其他应用领域中,例如,用作冠状动脉支架或用在身体的其他区域,例如胆管或输尿管内。
在切割技术的帮助下生产的箔通过电化学手段抛光,以消除毛刺和其他不规则物,从而获得平滑表面和圆滑边缘。本领域中技术人员应该理解这些电化学方法,因为这些方法已经用在医学技术中。就此而论,应该注意按照本发明的基于二维几何学和其上随后压印三维结构的支架可以比常规“管状”支架更容易制造和加工,所述常规“管状”支架在制造过程中,已经具有三维结构并需要复杂和昂贵的工作工艺和设备。
如上指出地,按照本发明的远侧段1的网状结构可以由单丝的编织物组成。所述针织结构显示在图16中,其中单丝22以具有形成网状结构31的单环23的“单面针织物(single jersey fabric)”形式交织。这种类型的单面针织品以已知的方式由一排针制成。单面针织品具有两个不同外观的织物侧面,即缝线的右侧和左侧。单面针织物材料的特性是横向的柔性很小和非常轻。
还可以使用由单股的编织品组成并形成绳的单丝。可以使用包括12-14股的具有总厚度0.02mm的编织品。铂、铂合金、金和不锈钢可以用作细丝的材料。一般而言,可以使用医学技术中已知的满足相关要求的全部永久性远侧段1材料。
在一个实施方案中,使所述针织结构的织物边缘卷起是有利的,如例如,由所谓的“Fluse”织物(德文术语)知晓的,其在重叠结构和对此处理的应用方面具有益处。在该情形中,重叠结构可以通过针织方法压印。然而,在这些情形中使用形状-记忆合金也是可行的和有效的。
为了生产所述针织的结构,可以使用已知的针织方法和技术。然而,由于按照本发明的远侧段具有非常小的尺寸——例如,2×1cm的尺寸——已经证实这有益于在常规的经编或纬编纺织品,非金属丝的框架中生产远侧段,例如,采用由各种金属丝组成的边缘的形式,所述纬编或经编织物由所述金属丝开始或所述金属丝从该织物延伸。纬编或经编织物在边缘处的金属部分的配置获得前述卷曲效果。该针织织物的非金属部分最终通过焚烧、化学破坏或利用合适溶剂溶解来去除。
图1显示具有与其相连的远侧段1的导丝7的组合,所述远侧段1由通过焊接法彼此连接的多根细丝组成。显示了远端2和连接点9,所述连接点9是远侧段1的细丝在锥形结构中会聚的位置并同时代表与导丝7连接的位置。将导丝7引入常规制造的微导管8。
在导管8中移动导丝7会导致远侧段1被推出或拉进该导管。当支架被推出微导管8时,网状结构试图采取压印在其上的重叠结构,且当被拉进来时,网状结构折叠回微导管中,以适应内部的可用空间。
作为其网状结构刚度的结果,远侧段1可以通过导丝7无限制地往复移动,直至其已经最佳地定位在血管系统中。
然而,如早先提到地,可以时常规微导管。按照本发明的远侧段1和按照本发明的远侧段1和导丝的组合的一个优势是在已用常规导丝/标记物系统将微导管置于合适位置后,可以将按照本发明的导丝7和远侧段1的组合引入微导管,在其中朝向植入部位移动和然后移出并施用于该位置。备选地,应该可能用具有较小口径的第二微导管容纳导丝7和远侧段1并利用在首先定位的微导管内的该第二微导管将它们移动至植入部位。在任意情形中,可以容易地双向引导远侧段1。
图17显示按照本发明的远侧段1处于其重叠或体积扩大形状或处于其体积缩小形状的图示。在其扩张形状中,如图17a中所示,远侧段1形成环形结构,边缘27和28略微重叠。在图17a中,远侧段1由其近端作为俯视图观察,其连接点9近似位于边缘27和28的对面。在按照本发明的组合中,导丝7固定在连接点9处。
图17b显示采用其体积缩小形式6的相同远侧段1,如其配置在例如处于卷起状态的微导管中。在图示的情形中,存在总共2圈卷起的远侧段1,其连接点9位于近侧,且两侧边27和28是卷圈或螺旋的起始点和终点。该结构通过微导管8保持为其体积缩小形式并且当远侧段1被推出微导管8时,其弹至其扩张形状,如图17a所示,类似于螺旋弹簧。
图18a显示适合于按照本发明的远侧段1的标记元件15,所述标记元件15能够配置在远侧段1的远端。标记元件15由柄33组成,所述柄33具有水平地配置在其内部的小标记板35,即与远侧段1的平面齐平,没有任何突出元件。板35由X射线反射材料,例如铂或铂-铱制成。标记板35可以与周围的远侧段1结构通过已知的激光焊接技术连接。如图18b中所示,标记元件15配置在远侧段1的远端。
如上提及地,在一个实施方案中,所述装置被配置成提供可去除的结合为一体的血栓装置团块。该配置可以以多种方式进行。例如,如图18c中可以看到地,标记元件15’可以以螺旋形式设置,由此增加网状结构的远端的支撑并帮助血栓取出。而且,如图18d中所示,标记元件15”可以作为孔眼形状提供,其以与螺旋标记物15’相似的方式起作用。图18e显示以钩或桩形状显示的标记元件15”’,其可以加入,从而在去除过程中提供额外的血栓滞留。标记元件15”任选不透射线或可以由与网状结构相同的形状记忆合金制成。
预期提供可去除的结合为一体的血栓装置团块的另外的结构构型包括:1)远侧段1的最远侧位置中的网状结构与网状结构的近侧相比更大的直径(或远侧段1远端上变宽的锥形);2)位于远侧段1最远侧的第三组多个网格,其中该第三组多个网格具有与第一组多个网格相比更小的网格尺寸;3)向网状结构添加合成聚合物或聚合纤维;和4)在足以为更好的血栓滞留赋予增加的径向强度的时间内加热远侧段1。
如上提及地,可以将纤维加入至网状结构。纤维可以包裹或缠绕网状结构。它们可以具有松散的末端或完全编织于整个远侧段1。
合适的纤维在美国公开号2006/0036281中教导,通过引用将其整体结合于此。在某些实施方案中,纤维可以包括聚合材料。所述聚合材料可以包括批准在身体内用作植入物或可以得到这样的批准的材料。它们可以是不能生物降解的聚合物诸如聚乙烯、聚丙烯酸酯、聚丙烯、聚氯乙烯、聚酰胺诸如尼龙,例如,尼龙6.6、聚氨酯、聚乙烯吡咯烷酮、聚乙烯醇、聚乙烯乙酸酯、醋酸纤维素、聚苯乙烯、聚四氟乙烯、聚酯诸如聚对苯二甲酸乙二酯(Dacron)、丝、棉、等。在某些特殊的实施方案中,用于聚合物组分的不能生物降解材料可以包括聚酯、聚醚、聚酰胺和多氟烃。
聚合物也可以是可生物降解的。代表性可生物降解聚合物包括:聚乙醇酸/聚乳酸(PGLA)、聚己酸内酯(PCL)、聚羟基丁酸戊酯(PHBV)、聚原酸酯(POE)、聚环氧乙烷/聚对苯二甲酸丁二醇酯(PEO/PBTP)、聚乳酸(PLA)、聚乙醇酸(PGA)、聚(对-二氧杂环己酮)、聚(valetolactone)、聚(丙醇二酸)、聚(β丙二酸)、聚(富马酸丙二醇酯)、聚(酐);和基于酪氨酸的聚碳酸酯。预期的另外的聚合物包括聚乙交酯和聚-L-丙交酯。
可以使用其他等价材料,包括但不仅限于前述任一项的立体异构体。
图19a和19b分别表示分离装置的两种变型,通过所述装置按照本发明的远侧段1与导丝7可拆卸地连接。在任一种情形中,分离装置由哑铃形元件43组成,其在电能感应下在与电解质接触时溶解。在哑铃形分离元件43的近(导丝侧)端,按照图19a,定位螺旋结构45,以与导丝7的加固螺旋体46相互作用。在远端,配置球形元件47,其在激光焊接技术的帮助下,与铂螺旋体48相连,铂螺旋体48再顺次与位于远侧段1近端的连接点9相连。铂螺旋体48还起远侧段1的X射线反射近侧标记物的作用。
为了加固球形元件47和连接点9之间的连接,可以设置增强线49。备选地,也可以以这样的方式设计铂螺旋体48,以使其经得起施加于其上的拉力和推力。
分离元件43可以包括在电能感应下易受电解质腐蚀的钢材料。为了加速腐蚀和缩短分离时间间隔,哑铃形元件43的结构或化学弱化可以是有益的,例如通过应用磨削法或热处理。
一般地,易受电解质影响的哑铃形部分43具有0.1-0.5mm,特别地0.3mm的长度。
螺旋结构45通过焊接固定至哑铃形元件43和导丝7的增强螺旋体46两者上。导丝7本身可滑动地容纳在微导管8内。
图19b显示与关于图19a所述的实施方案不同的第二实施方案,因为哑铃形元件43在每个端部具有球形元件47。球形元件47分别通过螺旋体48、46,在远侧与远侧段1的连接点9,和在近侧与导丝7相连。
当然还假设可以应用其他分离原理,例如,基于机械原理的那些或熔化掉塑料连接元件。
涂覆的装置
本发明还预期用抗凝血剂和/或抗血小板剂或药物涂覆所述装置。预期可以单独或与另一种药物组合使用的药物。
抗凝血剂(anticoagulant agent)或抗凝血剂(anticoagulant)是防止血液凝块形成的试剂。抗凝剂的实例包括,但不仅限于,凝血酶的特异性抑制剂、因子Ixa、因子Xa、因子XI、因子XIa、因子XIIa或因子VIIa、肝素及其衍生物、维生素K拮抗剂,和抗组织因子抗体,以及P-选择蛋白和PSGL-I的抑制剂。凝血酶特异性抑制剂的实例包括水蛭素(hirudin)、比伐卢定(bivalirudin)阿加曲班(argatroban)、希美加群(ximelagatran)达比加群(dabigatran)、和来匹卢定(lepirudin)肝素及其衍生物的实例包括未分馏的肝素(UFH)、低分子量肝素(LMWH),诸如依诺肝素(enoxaparin)达肝素(dalteparin)和达那肝素(danaparoid)和合成五糖,诸如磺达肝素(fondaparinux)依达肝素(idraparinux)和生物素化的依达肝素。维生素K拮抗剂的实例包括华法林(warfarin)phenocoumarol、醋硝香豆素(acenocoumarol)氯茚二酮(clorindione)、双香豆素(dicumarol)、二苯茚酮(diphenadione)、双香豆乙酯(ethylbiscoumacetate)、苯丙香豆素(phenprocoumon)、苯茚二酮(phenindione)、和噻氯香豆素(tioclomarol)。
抗血小板剂或血小板抑制剂是通过防止血小板聚集而阻断血液凝块形成的试剂。基于其活性,存在若干类型的抗血小板剂,包括GP IIb/IIIa拮抗剂,诸如阿昔单抗(abciximab)依替巴肽(eptifibatide)和替罗非班(tirofiban)P2Y12受体拮抗剂,诸如氯吡格雷(clopidogrel)噻氯匹定(ticlopidine)坎格雷洛(cangrelor)、ticagrelor、和普拉格雷(prasugrel);磷酸二酯酶III(PDEIII)抑制剂,诸如西洛他唑(cilostazol)双嘧达莫(dipyridamole)和(阿司匹林(aspirin)/缓释双嘧达莫);血栓烷合酶抑制剂,诸如呋格雷酸(furegrelate)、奥扎格雷(ozagrel)、利多格雷(ridogrel)和伊波格雷(isbogrel);血栓烷A2受体拮抗剂(TP拮抗剂),诸如伊非曲班(ifetroban)、雷马曲班(ramatroban)、特波格雷(terbogrel)、(3-{6-[(4-氯苯磺酰基)氨基]-2-甲基-5,6,7,8-四氢萘-1-基}丙酸(也称为Servier S18886,来自Recherches Internationales Servier,Courbevoie,法国);凝血酶受体拮抗剂,诸如SCH530348(具有化学名称:乙基(1R,3aR,4aR,6R,8aR,9S,9aS)-9-((E)-2-(5-(3-氟苯基)吡啶-2-基)乙烯基)-1-甲基-3-氧代十二氢萘并[2,3-C]呋喃-6-基氨基甲酸酯,来自先灵葆雅公司(Schering Plough Corp.),新泽西,美国,其记述在US2004/0192753A1和US2004/0176418A1中并在临床试验中研究,诸如A Multicenter,Randomized,Double-Blind,Placebo-Controlled Study to Evaluate the Safetyof SCH530348in Subjects Undergoing Non-Emergent PercutaneousCoronaryIntervention with ClinicalTrials.gov Idenfifier:NCT00132912(ClinicalTrials.gov标识符为NCT00132912的用于评估SCH530348在经历非紧急性经皮冠状动脉介入的受试者中安全性的多中心、随机化、双盲、安慰剂-对照研究));P-选择蛋白抑制剂,诸如2-(4-氯苄基)-3-羟基-7,8,9,10-四氢苯并[H]喹啉-4-羧酸(也称为PSI-697,来自Wyeth,新泽西,美国);和非甾体消炎药(NSAIDS),诸如乙酰水杨酸(acetylsalicylic acid)白藜芦醇(resveratrol)、布洛芬(ibuprofen) 萘普生(naproxen)舒林酸(sulindac)吲哚美辛(indomethacin)mefenamate、屈?昔康(droxicam)、双氯芬酸(diclofenac) 磺吡酮(sulfinpyrazone)和吡罗昔康(piroxicam)在NSAIDS中,乙酰水杨酸(ASA)、白藜芦醇和吡罗昔康是优选的。一些NSAIDS抑制环加氧酶-1(cox-1)和环加氧酶-2(cox-2),诸如阿司匹林和布洛芬。一些选择性抑制cox-1,诸如白藜芦醇,其是仅微弱抑制cox-2的可逆性cox—1抑制剂。
在一个实施方案中,药物的受控递送可以控制药物的溶解效果和治疗缺血性卒中和许多其他血管病。可以控制释放速率,以使得约50%的药物可以在约1-约120分钟内递送至血栓。这种受控的递送可以以一种或多种以下方式实现。第一,可以将药物和聚合物混合物施用于支架并可以增加聚合物的量或以较厚的层施用该组合。第二,支架可以首先用聚合物涂覆,再涂覆一层药物和聚合物,然后可以施用聚合物外涂层。药物的释放速率可以通过调节每层的厚度来改变。第三,可以制备用于提供容纳药物的储库的支架。在该实施方案中,将药物填充在支架表面上制造的小储库中。储库可以通过激光切割、机电化学、机械或化学处理来制造。
在刚刚所述的实施方案中,聚合物是生物相容的且可生物降解的。这些聚合物是本领域中公知的。
另外,支架可以涂覆药物洗脱涂层,诸如聚合物和药剂的组合。所述涂层可以利用本领域中充分确定的方法,诸如浸渍、喷雾、涂覆、和涂刷来施用。参见美国专利号6,214,115;美国专利号6,153,252;美国专利申请号2002/0082679;美国专利号6,306,166;美国专利号6,517,889;美国专利号6,358,556;美国专利号7,318,945;美国专利号7,438,925。
例如,Chudzik等(美国专利号6,344,035)教导一种方法,其中药剂或药物与聚合物的混合物诸如聚(甲基丙烯酸丁酯)和聚(乙烯-乙酸乙烯酯共聚物)组合施用。Guruwaiya等公开了一种用于涂覆支架的方法,其中将药理学试剂以在粘性底涂层上的干燥微粉化形式施用于支架(美国专利号6,251,136)。Ding等教导一种使用溶剂施用药物释放聚合物涂层的方法(美国专利号5,980,972),其中溶液通过喷雾或浸渍,顺序地或同时地施用于装置上,以形成聚合物和药剂的基本上均质的复合层。
尽管已经公开了本发明的多种示范性实施方案,但是本领域中技术人员应该清楚在不偏离本发明精神和范围的条件下,可以进行变化和改进,这应该获得本发明的一些优势。本领域中的普通技术人员应该清楚执行相同功能的其他部件可以适当地替换。
Claims (19)
1.一种可去除的结合的血栓装置团块,包括与装置至少部分接合的血栓,其中所述装置包括:
包括第一组多个格子的结构,所述结构具有近端和远端,所述近端和所述远端为开口的,并且所述第一组多个格子被配置为与所述血栓的至少一部分接合;
包括第二组多个格子的锥形部,所述锥形部朝向所述结构的近端布置;和
连接点,所述锥形部会聚在所述连接点处,所述连接点位于所述锥形部的近端,
其中所述自扩张装置被预成型以采取体积扩大形式且,在所述体积扩大形式中,其采用朝向所述连接点渐细的纵向开口管的形式。
2.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构的远端包括具有螺旋或孔眼形状的不透射线标记物。
3.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构的远端处于体积扩大形式时具有比处于所述体积扩大形式的结构的近端更大的直径。
4.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构的远端包括一个或多个桩和/或钩。
5.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构的远端包括纤维。
6.如权利要求1所述的可去除的结合的血栓装置团块,其中对所述结构的远端加热足够的时间,从而提供增加的径向强度。
7.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构涂覆有抗凝血剂或抗血小板药。
8.如权利要求7所述的可去除的结合的血栓装置团块,其中所述结构还涂覆有可生物降解的生物相容的聚合物,以提供抗凝血剂或抗血小板药的持续释放。
9.如权利要求1所述的可去除的结合的血栓装置团块,其中所述结构包括用于容纳凝血剂或抗血小板药的储库。
10.一种可扩张装置用于从动脉内处理和去除血栓的用途,其中所述装置包括:
包括第一组多个格子的结构,所述结构具有近端和远端,所述近端和所述远端为开口的,所述结构的远端被配置为与所述血栓的至少一部分接合,从而形成可去除的、结合的装置-血栓团块;
包括第二组多个格子的锥形部,所述锥形部朝向所述结构的近端布置;和
连接点,所述锥形部会聚在所述连接点处,所述连接点位于所述锥形部的近端,
其中所述自扩张装置被预成型以采取体积扩大形式且,在所述体积扩大形式中,其采用朝向所述连接点渐细的纵向开口管的形式。
11.如权利要求10所述的用途,其中所述结构的远端包括具有螺旋或孔眼形状的不透射线标记物。
12.如权利要求10所述的用途,其中所述结构的远端处于体积扩大形式时具有比处于所述体积扩大形式的结构的近端更大的直径。
13.如权利要求10所述的用途,其中所述结构包括在近侧部处的第一组多个格子、在锥形部处的第二组多个格子,且其中所述结构的远端包括第三组多个格子且其中所述第三组多个格子具有比所述第二组多个格子更小的格子尺寸。
14.如权利要求10所述的用途,其中所述结构的远端包括一个或多个桩和/或钩。
15.如权利要求10所述的用途,其中所述结构的远端包括纤维。
16.如权利要求10所述的用途,其中对所述结构的远端加热足够的时间,从而提供增加的径向强度。
17.如权利要求10所述的用途,其中所述结构涂覆有抗凝血剂或抗血小板药。
18.如权利要求17所述的用途,其中所述结构还涂覆有可生物降解的生物相容的聚合物,以提供抗凝血剂或抗血小板药的持续释放。
19.如权利要求10所述的用途,其中所述结构包括用于容纳凝血剂或抗血小板药的储库。
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