CN113827313A - 用于从血管移除凝块的凝块取回装置 - Google Patents
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Abstract
本发明题为“用于从血管移除凝块的凝块取回装置”。本发明公开了一种用于从血管移除凝块的凝块取回装置。该装置可包括塌缩构型和膨胀构型。装置可包括具有撑条框架的内部可膨胀主体。装置可包括具有撑条框架的外部可膨胀主体,撑条框架至少部分地径向围绕内部可膨胀主体。外部可膨胀主体的远侧部分可在部署构型中朝向外部可膨胀主体延伸至比内部可膨胀主体更大的程度,远侧部分的闭合单元朝远侧渐缩并且小于外部可膨胀主体中其近侧的单元。远侧部分的多个闭合单元可包括一对轴向对准的较小菱形单元,该对轴向对准的较小菱形单元由远侧部分的撑条形成并且沿远侧部分的上部区域和下部区域定位。
Description
技术领域
本发明整体涉及用于在血管内医学治疗期间从血管移除阻塞的装置和方法。
背景技术
在患者患有诸如急性缺血性中风(AIS)、心肌梗塞(MI)和肺栓塞(PE)等病症的情况下,在针对血管内干预的机械血栓切除术中经常使用凝块取回装置。急性阻塞物可包括凝块、错位装置、迁移装置、大栓塞等。当部分或全部血栓从血管壁脱离时,发生血栓栓塞。这种凝块(现在称为栓塞)随后沿血流方向运送。如果凝块滞留在大脑脉管系统中,则可能导致缺血性脑卒中。如果凝块起源于静脉系统或心脏右侧并滞留在肺动脉或其分支中,则可能导致肺栓塞。凝块也可不以栓塞的形式释放,而是在局部形成并堵塞血管,这种机制在形成冠状动脉堵塞中较为常见。设计可提供高水平性能的凝块移除装置存在重大挑战。首先,存在使得难以递送装置的许多进入挑战。在进入涉及导航主动脉弓(诸如冠状动脉或脑堵塞)的情况下,一些患者的弓构型使得难以定位引导导管。这些困难的弓构型被分类为2型或3型主动脉弓,其中3型弓呈现最大的困难。
在接近大脑的动脉中,曲折性挑战甚至更严重。例如,在颈内动脉的远侧端部处,装置将不得不在几厘米的血管中快速连续地导航具有180°弯曲、90°弯曲和360°弯曲的血管段,这种情况并不罕见。在肺栓塞的情况下,通过静脉系统并然后通过心脏的右心房和心室获得进入。右心室流出道和肺动脉是脆弱的血管,其很容易被不灵活或高轮廓的装置损坏。出于这些原因,期望凝块取回装置与尽可能低的轮廓和柔性的引导导管兼容。
其次,凝块可能滞留在的区域中的脉管系统通常是脆弱且纤弱的。例如,神经血管比身体其它部位的类似尺寸的血管更纤弱并且位于软组织床中。施加在这些血管上的过大拉力可能导致穿孔和出血。肺血管大于脑血管系统的血管,但其性质也很纤弱,特别是那些更远侧血管。
第三,凝块可以包括一系列形态和一致性中的任何一种。较软凝块材料的长线束可能倾向于在分叉处或三叉形处停留,导致多个血管同时在显著长度上被遮挡。更成熟且有组织的凝块材料可能比较软的较新鲜凝块更难以压缩,并且在血压作用下,其可能会使容纳该材料的顺应性血管扩张。此外,发明人已经发现了凝块的性质可以通过与其相互作用的装置的作用而显著改变。具体地,血凝块的压缩导致凝块脱水并导致凝块硬度和摩擦系数的显著增加。
对于任何装置需要克服上述挑战以便在移除凝块和恢复血流方面提供高水平的成功。现有装置无法充分解决这些挑战,尤其是与血管创伤和凝块特性相关联的那些挑战。
发明内容
本发明的目的是提供满足上述需求的装置和方法。因此,期望凝块取回装置从患有AIS的患者的脑动脉、患有MI的患者的冠状天生或移植血管和患有PE的患者的肺动脉以及凝块造成闭塞的其它外周动脉和静脉血管中移除凝块。
在一些示例中,公开了用于从血管中移除凝块的凝块取回装置。该装置可包括塌缩构型和膨胀构型。该装置可包括具有撑条框架的内部可膨胀主体。该装置可包括具有撑条框架的外部可膨胀主体,该撑条框架形成大于内部可膨胀主体的闭合单元的闭合单元并且至少部分地径向围绕内部可膨胀主体。外部可膨胀主体可包括远侧支撑架区,远侧支撑架区具有朝远侧渐缩的多个撑条,其具有小于外部可膨胀主体中其近侧的单元的闭合单元。远侧支撑架区的所述多个闭合单元可包括:第一多个闭合单元,该第一多个闭合单元为由远侧支撑架区的撑条形成的轴向对准的较小菱形单元;第二多个闭合单元,该第二多个闭合单元大于第一多个闭合单元中的单元并且径向分离,每个较小菱形单元径向向内并且位于第二多个闭合单元中的每个闭合单元的远侧;以及第三多个闭合单元,该第三多个闭合单元径向分离并且位于第二多个闭合单元中的每个闭合单元的近侧。
在一些示例中,第一多个闭合单元可包括与多个第二单元不同的形状。第二多个闭合单元可包括与第三多个闭合单元不同的形状。
在一些示例中,远侧支撑架区可为保护性撑条结构,该保护性撑条结构可包括位于第一多个闭合单元、第二多个闭合单元和第三多个闭合单元之间的至少十二个闭合单元。
在一些示例中,第一多个闭合单元可包括一对轴向对准的较小菱形单元,该对轴向对准的较小菱形单元由远侧部分的撑条形成并沿着远侧支撑架区的上部区域和下部区域定位。
在一些示例中,每个菱形单元可具有大约1.2mm的最佳配合直径。
在一些示例中,第二多个闭合单元可包括至少四个单元。
在一些示例中,该至少四个单元可具有大约1.6mm的最佳配合直径。
在一些示例中,该至少四个单元中的每个单元可与较小菱形单元中的一个菱形单元共享仅一条公共边缘。
在一些示例中,该至少四个单元中的每个单元可以是五边形。
在一些示例中,多个第三径向分离的单元可包括位于多个第二单元的近侧的至少五个径向分离的单元。
在一些示例中,远侧支撑架区的撑条连接到内部可膨胀主体。
在一些示例中,远侧支撑架区的撑条形成网孔状结构。
在一些示例中,远侧支撑架区可包括大于由在其近侧的外部可膨胀主体的所述多个撑条提供的孔隙率的孔隙率。
在一些示例中,公开了用于从血管中移除凝块的凝块取回装置。该装置可包括塌缩构型和膨胀构型。该装置可包括具有撑条框架的内部可膨胀主体。该装置可包括具有撑条框架的外部可膨胀主体,该撑条框架至少部分地径向围绕内部可膨胀主体。外部可膨胀主体的远侧部分可在部署构型中朝向外部可膨胀主体延伸至比内部可膨胀主体更大的程度,远侧部分的闭合单元朝远侧渐缩并且小于外部可膨胀主体中其近侧的单元。远侧部分的多个闭合单元可包括一对轴向对准的较小菱形单元,该对较小菱形单元由远侧部分的撑条形成并且沿远侧部分的上部区域和下部区域定位。
在一些示例中,远侧部分是保护性撑条结构,该保护性撑条结构可包括多个闭合单元中的至少十二个闭合单元。
在一些示例中,远侧部分的多个闭合单元可包括至少四个径向分离的较大单元,每个较小菱形单元径向向内并且位于至少四个径向分离的较大单元的远侧。
在一些示例中,至少四个径向分离的较大单元可具有大约1.6mm的最佳配合直径。
在一些示例中,至少四个径向分离的较大单元中的每个单元与较小菱形单元中的一个菱形单元共享仅一条公共边缘。
在一些示例中,至少四个径向分离的较大单元中的每个单元形成五边形。
在一些示例中,远侧部分的多个闭合单元可包括位于至少四个径向分离的较大单元的近侧的至少五个径向分离的单元。
在一些示例中,外部可膨胀主体的撑条框架可包括与相邻可膨胀构件间隔开的多个不连续的可膨胀构件,每个可膨胀构件的撑条可形成闭合单元,其中至少一些撑条终止于不连接到相邻闭合单元的径向分离的远侧顶点。
在一些示例中,该装置可包括位于相应可膨胀主体之间的多个凝块入口,凝块可穿过所述多个凝块入口并进入装置。
在一些示例中,每个构件可包括至少四个不透射线标记物,该至少四个不透射线标记物围绕外部可膨胀主体的纵向轴线同等地径向分离。
在一些示例中,至少四个不透射线标记物在塌缩构型中分开约10mm。
在一些示例中,至少四个不透射线标记物在膨胀构型中分开约8mm。
在一些示例中,至少四个不透射线标记物可包括定位在孔眼中的不透射线材料。
在一些示例中,至少四个不透射线标记物可包括硫酸钡、次碳酸铋、氯氧化钡、金、钨、铂、铱、钽或这些材料的合金中的至少一者。
在一些示例中,装置可包括纵向间隔开的至少三个可膨胀构件。
在一些示例中,远侧部分的多个闭合单元形成远侧网孔;内部可膨胀主体可包括闭合远侧部分,并且外部可膨胀主体的远侧部分是闭合的;并且外部可膨胀主体和内部可膨胀主体的远侧部分一起被构造成防止凝块或凝块碎片从装置的远侧流出。
在一些示例中,外部可膨胀主体能够膨胀到大于内部可膨胀主体的径向范围,以限定围绕外部管状主体的纵向轴线偏心布置的凝块接收空间。
在一些示例中,外部可膨胀主体可包括闭合远侧部分。
在一些示例中,闭合远侧部分的多个远侧撑条是螺旋形的。
在一些示例中,闭合远侧部分的多个远侧撑条垂直于外部可膨胀主体的纵向轴线延伸。
在一些示例中,闭合远侧部分的多个远侧撑条被构造成凸起或扩张的图案。
在一些示例中,外部可膨胀主体和内部可膨胀主体各自为整体结构。
在一些示例中,外部可膨胀主体可包括由一个或多个撑条连接的至少两个纵向间隔开的可膨胀构件,一个或多个撑条被构造为位于间隔开的可膨胀构件之间的纵向铰链,每个可膨胀构件可包括多个径向间隔开的不透射线标记物。
在一些示例中,每个标记物定位在相应可膨胀构件的至少两个连接撑条之间的结合部处。
在一些示例中,每个构件可包括至少四个不透射线标记物,该至少四个不透射线标记物围绕外部可膨胀主体的纵向轴线同等地径向分离。
在一些示例中,装置可包括纵向间隔开的至少三个可膨胀构件。
在一些示例中,不透射线标记物可包括定位在孔眼中的不透射线材料。
在一些示例中,不透射线标记物可包括硫酸钡、次碳酸铋、氯氧化钡、金、钨、铂、铱、钽或这些材料的合金中的至少一者。
在一些示例中,处于膨胀构型的流动通道的直径小于处于膨胀构型的外部可膨胀主体沿内部可膨胀主体与外部可膨胀主体之间的纵向延伸的凝块接收空间的直径的50%。
在一些示例中,装置可包括位于内部可膨胀主体和/或外部可膨胀主体的近侧端部的近侧延伸的轴。
在一些示例中,装置可包括连接到内部可膨胀主体的远侧部分的撑条。
在结合附图查看以下具体描述之后,本公开的其它方面和特征对于本领域普通技术人员将变得显而易见。
附图说明
将通过附图的如下描述进一步讨论本公开的上述及其它方面,在这些附图中,相同的编号指示各个图中相同的结构元件和特征。附图未必按比例绘制,而是将重点放在示出本公开的原理。附图仅以举例方式而非限制方式描绘了本发明装置的一种或多种具体实施。期望本领域的技术人员能够构思并组合来自多个附图的元件,以更好地满足使用者的需求。
图1示出了本公开的凝块取回装置的等轴视图。
图2示出了本公开的凝块取回装置的另一个示例的等轴视图。
图3示出了图1的装置的侧视图。
图4A示出了图1至图2的凝块取回装置的外部构件的侧平面视图。
图4B示出了图1至图2的凝块取回装置的外部构件的顶部平面图。
图5示出了图1的截面A-A的特写视图。
图6示出了图3的截面B-B的特写视图。
图7示出了图3的截面C-C的特写视图。
图8示出了图3的截面D-D的特写视图。
图9示出了图1的示例性凝块取回装置的远侧区域的特写等轴视图。
图10A示出了图9的远侧区域的端视图。
图10B示出了图9的远侧区域的等轴视图。
图10C示出了图9的远侧区域的顶视图。
图11A示出了示例性标记物的特写等轴视图。
图11B示出了图11A的示例性标记物的侧平面视图。
图12示出了处于塌缩构型的示例性外部构件的可膨胀构件的特写,其示出了示例性激光切割图案。
具体实施方式
现在参考附图详细描述本公开的具体示例,其中相同的参考标号表示功能性相似或相同的元件。这些示例解决了与传统导管相关的许多缺陷,诸如低效凝块移除以及将导管不准确地部署到目标部位。
接近血管内的各种血管(无论是冠状血管、肺血管还是脑血管)涉及熟知的手术步骤和许多常规的可商购获得的附件产品的使用。这些产品诸如血管造影材料和导丝广泛用于实验室和医学规程中。当这些产品与以下描述中的本公开的系统和方法结合使用时,其功能和确切构造未被详细描述。
以下具体实施方式本质上仅仅是示例性的,并不旨在限制本公开或本公开的应用和用途。虽然本公开的描述在许多情况下是在治疗颅内动脉的背景下,但本公开也可用于如前所述的其它身体通道中。
根据以上描述将显而易见的是,虽然已经图示并描述了本公开的具体实施方案,但是可在不脱离本公开的实质和范围的情况下进行各种修改。例如,虽然本文描述的实施方案涉及具体特征结构,但是本公开包括具有不同特征结构的组合的实施方案。本公开还包括不包括所描述的所有特定特征结构的实施方案。现在参考附图详细描述本公开的具体实施方案,其中相同的参考标号表示相同或功能性相似的元件。术语“远侧”或“近侧”用于下文有关相对于治疗医师的位置或方向的描述。“远侧”或“朝远侧”为远离医师的位置或在远离医师方向上。“近侧”或“朝近侧”或“在近侧”为靠近医师的位置或在朝向医师方向上。
进入脑血管、冠状血管和肺血管涉及使用许多可商购获得的产品和常规的程序步骤。进入产品诸如导丝、引导导管、血管造影导管和微导管在别处描述,并且常用于导管实验室程序中。在下文的描述中假定这些产品和方法与本公开的装置和方法结合使用,并且不需要详细描述。以下具体实施方式本质上仅仅是示例性的,并不旨在限制本公开或本公开的应用和用途。虽然本公开的描述在许多情况下是在治疗颅内动脉的背景下,但本公开也可用于如前所述的其它身体通道中。所公开的设计中的许多设计的共同主题是一种双层构造,其中该置包括外部可膨胀构件,内部可膨胀构件在该外部可膨胀构件内延伸,两个构件直接或间接连接到细长轴,并且该装置包括被构造成在装置的远侧端部处以防止凝块碎片逸出的远侧网或支撑架。该远侧网可以附加到轴、内部或外部构件或其中的几个。如本文件中所述,为这些元件中的每一个设想了一系列设计,并且这些元件中的任何一个都可以与任何其它元件结合使用,但为了避免重复,它们不会以任何可能的组合示出。
例如,内部可膨胀构件和外部可膨胀构件两者均有利地由这样的材料制成,该材料一旦从高度应变递送构型释放后就能够自动恢复其形状。超弹性材料诸如镍钛诺或类似性质的合金是特别合适的。该材料可为多种形式,诸如线状或条状或片状或管状。特别合适的制造工艺是激光切割镍钛诺管,然后对所得结构进行热定形和电抛光,以形成撑条和连接元件的框架。该框架可为如本文所公开的大范围形状中的任一种,并且可通过添加合金元素(例如,铂)或者通过各种其它涂层或标记带而在荧光镜透视检查下可见。在一些情况下,内部可膨胀构件可形成大致管状结构,并且理想地被构造成膨胀至直径比其旨在用于其中的最小血管的直径更小的直径。该直径通常小于外部可膨胀构件的直径的50%,可低至外部构件直径的20%或更小。本发明公开了一系列不同的远侧支撑架区设计,其中一些设计结合来自外部可膨胀构件和/或内部可膨胀构件的框架的撑条元件,并且其中一些设计结合细线或纤维以提供具有总体装置外形或可递送性的最小影响的添加的支撑架。合适的材料理想地具有高拉伸强度,从而可以生产具有足够完整性以用于可制造性和使用的超细线或纤维,诸如UHMWPE、芳族聚酰胺、LCP、PET或PEN之类的聚合物材料或诸如钨、MP35N、不锈钢或镍钛诺之类的金属。
图1示出了凝块取回装置100的一个实施方案,该凝块取回装置具有外部可膨胀构件102和内部可膨胀构件103,以便于在将装置100部署在阻塞性部位处之后立即恢复通过凝块的血流。如图所示,构件102可包括位于远侧部分的近侧的四(4)个可膨胀构件。然而,可以设想任何数量的可膨胀构件。例如,图2示出了具有构件102的更少可膨胀构件节段(例如,如图所示的两(2)个)的修改的装置100'。图3示出了装置100的侧面,但没有近侧轴。装置100具有细长轴106,该细长轴具有在动脉内部延伸的远侧端部和在动脉外部延伸的近侧端部。构件102和103具有用于递送的塌缩构型以及用于凝块取回、流动恢复和/或碎片化保护的膨胀构型。构件103可具有大致管状的主体节段。
构件103被构造成在从约束护套(例如,微导管)释放时自膨胀至大于构件102的直径的直径。构件102的膨胀可在膨胀期间导致凝块的压缩和/或移位。当可膨胀主体提供高水平的支撑架时,凝块被压缩。当可膨胀主体提供逃脱路径或开口时,膨胀主体将朝向开口推压凝块。然而,如果可膨胀主体仅提供适度的支撑架,则凝块将移位,但由于凝块具有许多自由度,因此其可在各种不同的方向上移动,并且因此不能被控制。通过提供管状可膨胀主体,其中管状可膨胀主体的长度基本上与闭塞凝块的长度一样长或更长,凝块可用的许多运动自由度被移除。
构件102和103可以特别地具有用于递送的塌缩构型以及用于流动恢复和碎片化保护的膨胀构型。构件102、103可在组装期间在近侧端部和远侧端部处接合,以最小化使用期间构件102、103内的张力。在其它示例中,构件103可根本不连接到构件103的远侧端部,或者可被约束在构件102内而不固定地附接。在其它示例中,构件103可具有非圆柱形横截面,直径可为不均匀的,并且可具有定制的撑条图案以提供具有不同径向力或柔性的区域。构件102的长度可与处于自由膨胀构型和装载的塌缩构型的构件103的长度基本上相同。
构件103可具有弹性或超弹性或形状记忆金属结构,并且可具有抛光表面,诸如电抛光表面。构件103可被构造成提供穿过装置100的流动管腔或流动通道(例如,大致圆柱形的节段),以便于在部署时恢复经过凝块的血流。在一个实施方案中,构件103被构造成通过凝块架起流动通道,以防止碎片的释放,否则碎片可能滞留在远侧脉管系统中。构件103可包括一个或多个连接的撑条131,所述一个或多个连接的撑条被构造成在最初部署在凝块内的目标血管中时接触凝块。所述一个或多个撑条131与凝块的接触提供额外的抓持,并且有助于在缩回装置100时凝块从血管的初始移位。
构件103的远侧端部可包括由直径大于构件103的直径的膨胀撑条110形成的可膨胀节段。这些膨胀撑条110可连接到线圈节段118(参见例如图8),该线圈节段可从构件103也可从其切割的管进行激光切割。线圈118还可被构造成通过拉伸来适应较小的长度差,而无需向装置100施加显著的张力或压缩力。线圈118可以由不锈钢材料、聚合物或更不透射线金属(诸如金或铂或这样材料的合金)形成。线圈118可以用纵向长度的弹性材料代替,诸如低模量聚合物或弹性体。线圈118的远侧端部可(例如,通过粘合剂、焊料、焊接或钎焊工艺)接合到构件102的远侧卡圈109。在一些示例中,撑条110可在装载期间伸长,使得构件102、103的长度在完全装载到微导管中时可相等。当装置100部署在小血管中时或在装载或部署过程期间,构件102、103之间的长度差仍可发生。
构件102和103优选地由超弹性材料或伪弹性材料制成,诸如镍钛诺或具有高可恢复应变的另一种这样的合金。轴106可以是锥形线轴,并且可以由不锈钢、MP35N、镍钛诺或具有适当高模量和拉伸强度的其它材料制成。轴106可具有指示带107以在插入期间指示装置100的远侧端部何时接近微导管的端部。轴106可具有邻近其远侧端部和构件102、103的近侧的线圈104。线圈104可以是金属的,并且可以由不锈钢或更不透射线材料(诸如铂或金或这样材料的合金)形成。在其它示例中,线圈104可以涂覆有低摩擦材料或者具有位于线圈104外表面上的聚合物护套。邻近线圈104,套筒105可定位在轴106上。套筒105可以是聚合物的并且可定位在轴106的锥形节段之上。可通过添加填充材料诸如钨或硫酸钡使套筒105不透射线。然而,可设想其它不透射线材料,包括但不限于次碳酸铋、氯氧化钡、金、铂、铱、钽或任何这些材料的合金。套筒105和轴106可涂覆有材料以减少摩擦和血栓形成性。涂层可包括聚合物、低摩擦润滑剂诸如硅、亲水性涂层或疏水性涂层。该涂层也可施加到构件102和构件103。
图4A示出了构件102的侧平面视图,而图4B示出了构件102的顶部平面图。入口开口122设置在构件102中,由此入口122可提供凝块可用的主要运动自由度,并且因此构件102的膨胀促使凝块进入接收空间111。构件102可具有多个入口122以接纳凝块。入口122可被构造成允许凝块的部分进入接收空间111,从而允许在不被过度压缩的情况下取回凝块。这是有利的,因为发明人已经发现凝块的压缩会使其脱水,这继而增加了凝块的摩擦特性,并且增加了其刚度,所有这些都使得凝块更难以从血管脱离和移除。如果在多孔结构朝向血管壁向外迁移时凝块穿过构件102的壁向内迁移,则可避免这种压缩。
入口122还可提供允许构件102在缩回时沿基本上平行于凝块从血管中拉出的方向(即基本上平行于血管的中心轴线)的方向向凝块施加力的附加益处。这意味着施加到脉管系统的向外径向力可以保持最小,这进而意味着凝块取回装置100对凝块的作用不会用于增加从血管中移出凝块所需的力,从而保护脆弱的脑血管免受有害的径向力和拉伸力。
如图所示,构件102可包括近侧撑条120,该近侧撑条在其近侧端部处连接到卡圈112并且在其远侧端部处连接到第一可膨胀构件126,这在图6的截面B-B处更清楚地示出。如图所示,撑条120可具有锥形轮廓,以确保从轴106到装置的凝块接合节段的逐渐刚度过渡。构件126可通过多个连接臂129连接到第二可膨胀构件127,这些连接臂可从近侧结合部139延伸到远侧结合部140。臂129可以包括平行于装置的中心轴线延伸的大致直的撑条。在其它实施方案中,这些连接臂可以包括被构造在一个或多个单元中的多个撑条,或者可以包括弯曲或螺旋臂。第一可膨胀构件和第二可膨胀构件之间的区域包括两个入口122,凝块可穿过所述两个入口并进入由内部构件和外部构件之间的区域限定的接收空间111。
构件127继而可通过从近侧结合部141延伸到远侧结合部142的连接臂130连接到第三可膨胀构件128。臂130可以包括平行于装置100的中心轴线延伸的大致直的撑条。在一些示例中,臂130可以包括被构造在一个或多个单元中的多个撑条,或者可以包括弯曲或螺旋臂。构件127、128之间的区域可包括一个或多个入口122,凝块可穿过所述一个或多个入口并进入由构件102、103之间的区域限定的接收空间111。构件126、127之间的臂129可以与构件127、128之间的臂130基本上对准,以在弯曲期间对准构件126、127、128的中性轴线。在其它示例中,构件126、127之间的臂129可以与构件127、128之间的臂130成诸如90度的角度对准。
在一些示例中,构件126可包括互连撑条诸如终止于没有远侧连接元件的冠部133的撑条143,以及其它撑条诸如终止于结合点145和146的144。可膨胀构件中的撑条可被构造成使得在装载期间,多个冠部(例如,冠部145、150)不在距近侧卡圈112相同的距离处对准。在装载或再次套入期间,通常可能需要比撑条更高的力来将冠部装载到护套中。因此,如果同时装载多个冠部,则用户可注意到装载力的增加。通过使另选的撑条144和151具有不同的长度来偏移冠部(例如,冠部145、150),可减小装载力并且改善用户的感知。类似地,第二可膨胀构件127可包括互连撑条诸如终止于没有远侧连接元件的冠部134的撑条147,以及终止于结合点的其它撑条(例如,撑条148)。类似地,第三可膨胀构件128可包括互连撑条诸如终止于没有远侧连接元件的冠部135的撑条152,以及终止于结合点的其它撑条。图7示出了图3的截面C-C的近视图,其更清楚地示出了构件128及其撑条(例如,撑条152)和冠部135。如图所示,构件102可包括更少或更大的可膨胀构件126、127、128。
在一些示例中,构件102的可膨胀构件可包括具有不透射线材料的一个或多个标记物125,诸如但不限于诸如金、钨、钽、铂或含有这些或其它高原子序数元素的合金的不透射线材料。也可采用聚合物材料(例如,聚氨酯、聚醚嵌段酰胺、尼龙、聚乙烯等),该聚合物材料包含不透射线填料诸如硫酸钡、次碳酸铋、氯氧化钡、金、钨、铂、铱、钽、这些材料的合金和/或填充有不透射线填料的粘合剂。在这方面,标记物125可作为撑条上的孔眼包括在整个构件102中。标记物125可被定位成向用户指示构件102的筒节段的远侧端部以辅助部署的准确性。构件102的远侧端部可包括连接到一系列撑条124的撑条123的圆周环,所述一系列撑条可终止于远侧结合点109,该远侧结合点可包括卡圈。在一些示例中,构件102可终止于闭合远侧端部,而在其它方面,构件102的远侧端部可打开或不必是闭合的。在一些示例中,撑条124可包括大致圆锥形状,如图所示。在一些示例中,撑条124可被布置在大致平坦的平面中,该平面可为倾斜的或可垂直于装置100的纵向轴线。撑条124和149可渐缩至比包括可膨胀构件(例如,构件126、127、128等)的主体的更近侧撑条的宽度更窄的宽度,从而在膨胀状态和塌缩状态两者下产生装置的刚度的逐渐过渡。
图5是图1的截面A-A的特写视图,其更清楚地示出了在构件126上并沿着构件交错的示例性标记物125。应当理解,如图7和本公开通篇所示的标记物125的位置仅仅是示例性的,并且标记物125可被包括在其它地方并且具有装置100的其它特征。在一些示例中,标记物125可在塌缩递送构型中分开约10mm,并且在膨胀构型中分开约8mm。然而,标记物125不限于此,并且可根据需要或要求分开。
图8示出了图3的截面D-D的特写视图,其更清楚地示出了远侧区域155,而图9示出了图3的截面E-E处的装置100的远侧区域155(这里有时可互换地称为远侧支撑架区)的特写等轴视图。图10A(端视图)和图10B(等轴视图)仅示出了构件102的远侧区域155,其中被构造用于碎片保护特征的区域155的三维远侧网孔由撑条框架产生。如图所示,图9至图10C所示的远侧区域155的多个顶点或冠部184被设置成连接到其近侧的多个臂182,所述多个臂终止于邻近卡圈109的结合部处。臂182可以根据需要或要求成形,包括如图所示的大致弓形或圆锥形。优选地,臂182形成多个闭合单元,所述多个闭合单元从区域155近侧端部处或附近的较大闭合单元逐渐变为远侧端部处或附近的较小闭合单元。在一些示例中,可在装置100的远侧区域155中提供至少十二个闭合单元。所示的远侧区域155可包括构件102的闭合远侧端部,该闭合远侧端部与由区域155的臂182和对应的闭合单元形成的网孔一起可防止已进入先前所述的构件102、103之间的接收空间111的凝块或凝块碎片的流出。
在一些示例中,轴向对准的较小菱形单元187可由臂182形成并且沿远侧网孔的上部区域和下部区域定位。在一些示例中,提供了至少两个单元187。较大的单元189可围绕装置100的纵向轴线L径向定位并且沿单元187的径向向内定位。在一些示例中,至少四个单元189被提供为在邻近卡圈109的结合部处或附近接合。在一些示例中,单元189可测量为大约1.2mm,所述测量结果为放置在相应单元(例如,在图10C的顶视图中绘出的单元187)中的圆的最佳配合直径的尺寸。在其它示例中,单元189可测量得更大(例如,大约1.6mm)。
单元186也可设置在单元187、189的近侧。在一些示例中,围绕轴线L径向分离的至少五(5)个单元186可定位在单元187、189的近侧。单元186中的每个单元可包括与单元187、189以及冠部184共用的撑条。在一些示例中,单元186中的每个单元的近侧撑条可以是弓形的或以其它方式弯曲的。在一些示例中,图9至图10C所示的远侧区域155可以是与构件102近侧的区域一体形成的整体结构(例如,通过由与构件102的其余部分相同的管激光加工而成)。在一些示例中,不透射线线圈108(例如,由铂、金、合金等形成)可定位在远侧区域155的远侧,该远侧区域被构造成在远侧卡圈109处或抵靠远侧卡圈联接。
图11A示出了示例性标记物125的特写等轴视图,而图11B示出了标记物125的侧平面视图。所示标记物125通常由铂-铱形成,但如前所述,可根据需要或要求设想其它不透射线材料。
图12示出了处于塌缩构型的可膨胀构件127的特写,其示出了具有增强的可见度的示例性激光切割图案。应当理解,构件102的其它可膨胀构件可遵循相同或类似的图案。构件12可包括交错地用于标记物125的三(3)个孔眼切口。在其它示例中,构件12可包括交错地用于标记物125的四(4)个孔眼切口。根据需要或要求,可包括更少或更多的孔眼切口以结合标记物125。在具有4个孔眼切口的那些示例中,构件102的每个可膨胀构件可包括4个标记物125。在这方面,如果构件102将具有三个可膨胀构件,则构件102可包括贯穿交错的总共至少十二个标记物125。如果构件102将具有四个可膨胀构件,则可包括至少二十个标记物125,其中构件102贯穿地交错。
本公开不限于所描述的示例,这些示例的构型和细节可变化。术语“远侧”和“近侧”在整个前述描述中使用,并且是指相对于治疗医师的位置和方向。同样,“远侧”或“朝远侧”是指远离医师的位置或在远离医师的方向上。类似地,“近侧”或“朝近侧”是指靠近医师的位置或在朝向医师的方向上。
在描述示例时,为了清楚起见,采用了术语。旨在使每个术语设想其本领域技术人员理解的最广泛的含义,并且包括以类似方式操作以实现类似目的的所有技术等同物。还应当理解,提到方法的一个或多个步骤不排除存在附加的方法步骤或在那些明确标识的步骤之间的中间方法步骤。在不脱离所公开技术的范围的情况下,可按照与本文所述的顺序不同的顺序执行方法的步骤。类似地,还应当理解,提到装置或系统中的一个或多个部件不排除存在附加的部件或在那些明确标识的部件之间的中间部件。
如本文所讨论的,“患者”或“个体”可以是人或任何动物。应当理解,动物可以是各种任何适用的类型,包括但不限于哺乳动物、兽医动物、家畜动物或宠物类动物等。例如,动物可以是专门选择具有与人类相似的某些特性的实验动物(例如,大鼠、狗、猪、猴等)。
如本文所用,针对任何数值或范围的术语“约”或“大约”指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地,“约”或“大约”可是指列举值的值±20%的范围,例如“约90%”可是指71%至99%的值范围。范围可在本文中表示为“约”或“大约”一个特定值和/或“约”或“大约”另一个特定值。当表达此种范围时,其它示例性实施方案包括从一个特定值和/或到另一特定值。
“包含”或“含有”或“包括”是指至少命名的化合物、元素、颗粒或方法步骤存在于组合物或制品或方法中,但不排除存在其它化合物、材料、颗粒、方法步骤,即使其它此类化合物、材料、颗粒、方法步骤具有与命名的那些相同的功能。
还应该注意的是,除非上下文清楚地指明,否则本说明书和所附权利要求中所用的单数形式“一个/一种”和“所述/该”包括复数指代物。
本文所包含的描述为本公开的示例,并且不旨在以任何方式限制本公开的范围。虽然描述了本公开的具体示例,但在不脱离本公开的范围和精神的前提下,可对装置和方法进行各种修改。例如,虽然本文所述的示例涉及特定部件,但本公开包括利用部件的各种组合实现所述功能、利用另选的材料实现所述功能、组合各个示例的部件、将各个示例的部件与已知部件组合等的其它示例。本公开设想用其它熟知的和可商购获得的产品替换本文所示的组成部件。对于本公开所涉及的领域内的普通技术人员而言,这些修改通常是显而易见的并且旨在落入以下权利要求书的范围。
Claims (20)
1. 一种用于从血管中移除凝块的凝块取回装置,所述装置包括塌缩构型和膨胀构型并且包括:
内部可膨胀主体,所述内部可膨胀主体包括撑条框架;以及
外部可膨胀主体,所述外部可膨胀主体包括形成大于所述内部可膨胀主体的闭合单元的闭合单元并且至少部分地径向围绕所述内部可膨胀主体的撑条框架,所述外部可膨胀主体包括远侧支撑架区,所述远侧支撑架区包括朝远侧渐缩的多个撑条,其具有小于所述外部可膨胀主体中其近侧的单元的闭合单元;
所述远侧支撑架区的多个闭合单元包括:
第一多个闭合单元,所述第一多个闭合单元为由所述远侧支撑架区的撑条形成的轴向对准的较小菱形单元;
第二多个闭合单元,所述第二多个闭合单元大于所述第一多个闭合单元中的单元并且径向分离,每个较小菱形单元径向向内并且位于所述第二多个闭合单元中的每个第二闭合单元的远侧;以及
第三多个闭合单元,所述第三多个闭合单元径向分离并且位于所述第二多个闭合单元中的每个第二闭合单元的近侧。
2.根据权利要求1所述的装置,其特征在于,所述第一多个闭合单元包括与所述多个第二单元不同的形状;并且
所述第二多个闭合单元包括与所述第三多个闭合单元不同的形状。
3.根据权利要求1所述的装置,其特征在于,所述远侧支撑架区为保护性撑条结构,所述保护性撑条结构包括位于所述第一多个闭合单元、所述第二多个闭合单元和所述第三多个闭合单元之间的至少十二个闭合单元。
4.根据权利要求1所述的装置,其特征在于,所述第一多个闭合单元为一对轴向对准的较小菱形单元,所述一对轴向对准的较小菱形单元由所述远侧部分的撑条形成并且沿所述远侧支撑架区的上部区域和下部区域定位。
5.根据权利要求4所述的装置,其特征在于,每个菱形单元具有大约1.2mm的最佳配合直径。
6.根据权利要求4所述的装置,其特征在于,所述第二多个闭合单元包括至少四个单元。
7.根据权利要求6所述的装置,其特征在于,所述至少四个单元具有大约1.6mm的最佳配合直径。
8.根据权利要求6所述的装置,其特征在于,所述至少四个单元中的每个单元与所述较小菱形单元中的一个菱形单元共享仅一条公共边缘。
9.根据权利要求6所述的装置,其特征在于,所述至少四个单元中的每个单元是五边形。
10.根据权利要求6所述的装置,其特征在于,多个第三径向分离的单元包括位于所述多个第二单元的近侧的至少五个径向分离的单元。
11. 一种用于从血管中移除凝块的凝块取回装置,所述装置包括塌缩构型和膨胀构型,并且包括:
内部可膨胀主体,所述内部可膨胀主体包括撑条框架;以及
外部可膨胀主体,所述外部可膨胀主体包括至少部分地径向围绕所述内部可膨胀主体的撑条框架;并且
所述外部可膨胀主体的远侧部分在部署的构型中朝向所述外部可膨胀主体延伸至比所述内部可膨胀主体更大的程度,所述远侧部分的闭合单元朝远侧渐缩并且小于所述外部可膨胀主体中其近侧的单元;
所述远侧部分的所述多个闭合单元包括一对轴向对准的较小菱形单元,所述一对轴向对准的较小菱形单元由所述远侧部分的撑条形成并且沿所述远侧部分的上部区域和下部区域定位。
12.根据权利要求11所述的装置,其特征在于,所述远侧部分为保护性撑条结构,所述保护性撑条结构包括所述多个闭合单元中的至少十二个闭合单元。
13.根据权利要求11所述的装置,其特征在于,所述远侧部分的所述多个闭合单元包括至少四个径向分离的较大单元,每个较小菱形单元径向向内并且位于所述至少四个径向分离的较大单元的远侧。
14.根据权利要求13所述的装置,其特征在于,所述至少四个径向分离的较大单元具有大约1.6mm的最佳配合直径。
15.根据权利要求13所述的装置,其特征在于,所述至少四个径向分离的较大单元中的每个单元与所述较小菱形单元中的一个菱形单元共享仅一条公共边缘。
16.根据权利要求13所述的装置,其特征在于,所述至少四个径向分离的较大单元中的每个单元是五边形。
17.根据权利要求13所述的装置,其特征在于,所述远侧部分的所述多个闭合单元包括位于所述至少四个径向分离的较大单元的近侧的至少五个径向分离的单元。
18.根据权利要求11所述的装置,其特征在于,所述外部可膨胀主体的所述撑条框架包括与相邻可膨胀构件间隔开的多个不连续的可膨胀构件,每个可膨胀构件的撑条形成闭合单元,其中至少一些撑条终止于不连接到相邻闭合单元的径向分离的远侧顶点,每个构件包括至少四个不透射线标记物,所述至少四个不透射线标记物围绕所述外部可膨胀主体的纵向轴线同等地径向分离。
19.根据权利要求18所述的装置,其特征在于,所述至少四个不透射线标记物在所述塌缩构型中分开约10mm。
20.根据权利要求18所述的装置,所述至少四个不透射线标记物包括硫酸钡、次碳酸铋、氯氧化钡、金、钨、铂、铱、钽或这些材料的合金中的至少一者。
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US10939931B2 (en) | 2018-06-19 | 2021-03-09 | Stryker Corporation | Embolectomy device having multiple embolectomy structures |
US11090071B2 (en) | 2018-06-22 | 2021-08-17 | Covidien Lp | Electrically enhanced retrieval of material from vessel lumens |
WO2020039082A1 (en) | 2018-08-24 | 2020-02-27 | Neuravi Limited | Apparatus for managing acute ischemic events |
US10842498B2 (en) | 2018-09-13 | 2020-11-24 | Neuravi Limited | Systems and methods of restoring perfusion to a vessel |
US11406416B2 (en) | 2018-10-02 | 2022-08-09 | Neuravi Limited | Joint assembly for vasculature obstruction capture device |
WO2021113302A1 (en) | 2019-12-02 | 2021-06-10 | Razack Intellectual Properties, LLC | Thrombectomy devices and methods |
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JP2022002695A (ja) | 2022-01-11 |
US20210393279A1 (en) | 2021-12-23 |
EP3928721A1 (en) | 2021-12-29 |
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