CN113520522A - 用于从血管移除凝块的浮置凝块取出装置 - Google Patents

用于从血管移除凝块的浮置凝块取出装置 Download PDF

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CN113520522A
CN113520522A CN202110411651.XA CN202110411651A CN113520522A CN 113520522 A CN113520522 A CN 113520522A CN 202110411651 A CN202110411651 A CN 202110411651A CN 113520522 A CN113520522 A CN 113520522A
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A·德维迪
P·康诺利
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
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    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material

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Abstract

本发明题为“用于从血管移除凝块的浮置凝块取出装置”。本发明提供了一种凝块移除装置，包括：细长构件，该细长构件包括远侧端部；以及可扩展框架，该可扩展框架包括近侧端部以及一个或多个框架构件，该框架构件包括可操作为可滑动且可旋转地设置在其上的一个或多个夹紧式单元，夹紧式单元中的每一个包括处于微导管内的塌缩状态以及微导管远侧处被构造成镊夹凝块的至少一部分的扩展状态。

Description

用于从血管移除凝块的浮置凝块取出装置
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
通常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使用凝块取出装置。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，存在使得难以传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。由于这些原因，期望凝块取出装置与尽可能低的轮廓和柔性的引导导管兼容。
第二，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，神经血管比身体其他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。现有的装置无法充分地解决这些挑战，尤其是与血管创伤和凝块特性相关的那些挑战。
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，希望凝块取出装置从患有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他外周动脉和静脉血管中移除凝块。
在一些示例中，装置包括被构造用于靠近阻塞物(例如中颈内动脉(ICA))放置的夹紧特征部。装置可被构造成再灌注血管和/或移除具有纤维蛋白核心的凝块。在一些示例中，纤维蛋白核心可处于由相对软的血栓包围的凝块中的中间或远侧位置。
在一些示例中，装置可被构造成移除M1分叉中的凝块。
在一些示例中，装置可被构造成移除M2分叉中的凝块。
在一些示例中，该装置可包括细长构件，该细长构件包括远侧端部；以及可扩展框架，该可扩展框架具有近侧端部以及一个或多个框架构件，该框架构件具有可操作为可滑动且可旋转地设置在其上的一个或多个夹紧式单元。每个夹紧式单元可包括处于微导管内的塌缩状态以及微导管远侧处可操作为镊夹凝块的至少一部分的扩展状态。
在一些示例中，一个或多个夹紧式单元可包括多个撑条构件，该多个撑条构件可操作为致动且在多个撑条构件之间从血管镊夹凝块。
在一些示例中，多个撑条构件可围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。
在一些示例中，一个或多个夹紧式单元中的每一个可操作为在从塌缩状态移动到扩展状态的凝块夹紧状态时镊夹凝块，直至凝块的一部分被压缩在多个撑条构件之间。
在一些示例中，一个或多个夹紧式单元中的每一个的直径在塌缩状态与扩展状态之间的比率可为约1.5:1至4:1。
在一些示例中，一个或多个夹紧式单元中的每一个可包括不透射线标记物。
在一些示例中，一个或多个夹紧式单元可包括夹紧式结构，该夹紧式结构包括多个撑条构件和一个或多个中心撑条构件；具有第一轴环管腔的第一轴环；以及具有第二轴环管腔的第二轴环。
在一些示例中，一个或多个撑条构件可以为可操作为镊夹有凝块的至少一部分的撑条网络，撑条网络可被构造成使得在扩展状态下，撑条网络的至少一部分穿透凝块。
在一些示例中，第一轴环管腔和第二轴环管腔可操作为接纳一个或多个框架构件。
在一些示例中，细长构件具有远侧端部；并且其中细长构件的远侧端部可附接到可扩展框架的近侧端部。
在一些示例中，一个或多个夹紧式单元可选择性地在一个或多个框架构件上以多个取向对准。
在一些示例中，可扩展框架通常为具有沿其长度波幅递增的波模式。
在一些示例中，公开了一种用于移除凝块的方法。该方法可包括将可扩展框架在血管内凝块附近从递送构型部署成展开构型。可扩展框架可包括一个或多个框架构件以及位于一个或多个框架构件上的一个或多个夹紧式单元。每个夹紧式单元可包括处于微导管内的塌缩状态以及微导管远侧处被构造成夹紧凝块的至少一部分的扩展状态，可扩展框架被部署成使得一个或多个夹紧式单元可以与凝块接触。该方法可包括相对于可扩展框架推进微导管的管腔，使得可扩展框架的一部分至少部分地塌缩到微导管的管腔中，并且一个或多个夹紧式单元至少部分地塌缩到微导管的管腔中。该方法可包括在从塌缩状态移动到扩展状态的凝块夹紧状态时，使与凝块的部分接触的一个或多个夹紧式单元紧缩，直至凝块的一部分可被压缩在一个或多个夹紧式单元的至少一对撑条构件之间；以及在使一个或多个夹紧式单元紧缩的同时撤回微导管、可扩展框架、以及凝块。
在一些示例中，撑条构件对可操作为致动且在撑条构件对之间从血管镊夹的凝块。
在一些示例中，撑条构件对可围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。
在一些示例中，公开了一种用于制造装置的方法。该方法可包括由形状记忆合金管形成一个或多个夹紧式单元。一个或多个夹紧式单元中的每一个可包括可操作为夹紧凝块的多个撑条构件，多个撑条构件围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。该方法可包括形成可扩展框架的具有近侧端部和一个或多个框架构件的至少一部分。该方法可包括将一个或多个夹紧式单元与可扩展框架的至少一部分组装在一起。
在一些示例中，由形状记忆合金管形成一个或多个夹紧式单元可包括将形状记忆合金管切割成多个区段；在所述多个区段的一个区段中切割一种模式；将不透射线标记物附着到所述一个或多个夹紧式单元中的每一个；并且对夹紧式结构的多个撑条构件和一个或多个中心撑条构件进行形状设定以记忆夹紧式结构的扩展状态，一个或多个夹紧式单元中的每一个的直径在塌缩状态与扩展状态之间的比率可为约1.5:1至4:1。
在一些示例中，形成可扩展框架的至少一部分可包括在芯轴上构造一个或多个框架构件；至少部分地基于所述芯轴使一个或多个框架构件成形，以记忆所述可扩展框架的展开构型；以及连接一个或多个框架构件，以形成可扩展框架的远侧端部。
在一些示例中，将一个或多个夹紧式单元与可扩展框架的至少一部分组装在一起可包括在一个或多个框架构件上滑动一个或多个夹紧式单元；以及连接一个或多个框架构件，以形成可扩展框架的近侧端部，其中一个或多个夹紧式单元可选择性地以多个取向对准。
在一些示例中，一个或多个夹紧式单元可包括具有第一轴环管腔的第一轴环；包括第二轴环管腔的第二轴环；并且其中第一轴环管腔和第二轴环管腔可操作为接纳一个或多个框架构件，并且其中多个撑条构件和一个或多个中心撑条构件可以为可操作为接合凝块的至少一部分的撑条网络。撑条网络可被构造成使得在扩展状态下，撑条网络的至少一部分穿透凝块。
在结合附图查看以下具体描述之后，本公开的其他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他方面，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1A示出了示例性夹紧式单元的近距离视图。
图1B示出了示例性夹紧式单元在线上的移动。
图2A示出了展开构型的示例性凝块移除装置。
图2B示出了递送构型的示例性凝块移除装置。
图3为示出用于移除凝块的方法的流程图。
图4A示出了穿透凝块的示例性凝块移除装置的近距离视图。
图4B示出了夹紧凝块的示例性凝块移除装置的近距离视图。
图4C示出了捕获凝块的示例性凝块移除装置的近距离视图。
图5示出了示例性凝块移除装置的示例性框架模式。
图6示出了示例性凝块移除装置的示例性框架模式。
图7A-7B示出了示例性凝块移除装置的示例性框架模式。
图8A-8B示出了示例性凝块移除装置的示例性框架模式。
图9示出了示例性凝块碎片收集部分。
图10为示出制造凝块移除装置的方法的流程图。
图11A-11C示出了处于a)扩展状态，b)塌缩状态，c)扩展状态的紧缩状态的夹紧式单元。
图12A-12D示出了根据本公开的各方面的示例性夹紧式单元。
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情况下进行的，但本公开也可用于先前所述的其他身体通道中。
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情况下进行的，但本公开也可用于先前所述的其他身体通道中。
图1A示出了示例性夹紧式单元100的近距离视图。夹紧式单元100可构造成嵌入凝块和/或与凝块接合并夹持凝块，以牢固地保持凝块用于回缩。应当理解，本文所述的夹紧式单元中的每一个可根据需要或要求与凝块取出装置互换使用。夹紧式单元100可包括第一轴环102、第一管腔104、第二轴环106和第二管腔108，夹紧式结构110定位在它们之间(例如介于第一轴环与第二轴环之间)。夹紧式结构110可包括撑条构件112a、112b、112c和112d。撑条构件112a、112b、112c和112d中的一个或多个可被构造成弓形或以其他方式包括张紧的挠曲，以便能够嵌入凝块中，然后在使用期间被致动以夹持和/或夹紧凝块。术语“弓形”旨在是指大致呈弧形的撑条，而“张紧挠曲”旨在是指置于张紧之下且塑性变形为期望形状的撑条。
在一些示例中，夹紧式单元100可通过如下方式致动为扩展状态的紧缩状态：从护套(例如微导管)抽出，由一个或多个牵拉构件而被牵拉或致动，将电流递送至撑条构件112a、112b、112c和112d中的一个或多个，以使得撑条构件112a、112、112c和112d中的一个或多个的至少第一部分从扩展状态变为紧缩状态。夹紧式单元100可被构造成嵌入并夹持、夹紧和/或“镊夹”凝块，如在图11A-C中更具体地示出和描述的。如本文所讨论，术语“镊夹”或“钳夹”旨在是指夹紧式或紧握式单元入鞘，使得相应的撑条聚集在一起并且镊夹或夹持凝块的至少一部分。在这方面，尽管不必限制相应单元中撑条的数量，但可以包括至少两个撑条表面，以便镊夹相应的凝块材料。一个或多个撑条构件112a、112b、112c和112d还可具有一个或多个不透射线带，以向使用者指示何时夹紧式单元100缩紧，因为当夹紧式单元100从扩展状态转变为扩展状态的紧缩状态时撑条之间的距离减小。
夹紧式单元100的直径可在约2-10毫米之间的范围内，这取决于设计轮廓允许的程度。一个优选的直径可为约2.25毫米。在一些示例中，夹紧式单元100可小到足以适配在0.021或0.018英寸ID的微导管中。
夹紧式单元100可由超弹性材料诸如镍钛诺或类似特性的合金构造。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，以形成撑条的框架。该框架可为如本文所公开的大量形状中的任何一种，并且可通过添加合金元素(例如铂)或者通过各种其他涂层或标记带而在荧光镜透视检查下可见。夹紧式单元100可包括用于递送的塌缩状态，以及用于凝块取出、血流恢复和/或碎裂保护的微导管远侧的扩展状态。为了在塌缩状态与扩展状态之间移动，夹紧式单元100可被构造成在从微导管递送(例如从微导管释放)时自扩展到扩展直径，如在图11A-11C中详细讨论的。
转到图1B，示出了设置在可穿过第一管腔104和第二管腔108的线114上的示例性夹紧式单元100。在这方面，通过线114可以允许夹紧式单元100沿A轴滑动(如由箭头S所示)，并且绕A轴旋转(如由箭头R所示)。A轴可以被限定为例如与线114或类似的工具对准。
图2A示出了展开构型的示例性凝块移除装置200。示例性装置200可包括微导管202，该微导管具有管腔204、远侧端部206和近侧端部208。装置200可包括可扩展框架210，该可扩展框架具有远侧端部212、近侧端部214以及一个或多个框架构件216a、216b和216c。一个或多个框架构件216a、216b和216c可具有可滑动地和/或可旋转地设置在其上的一个或多个夹紧式单元100，如图1B所讨论。装置200可包括具有远侧端部219的细长构件218。细长构件218的远侧端部219可附接到可扩展框架210的近侧端部214。可扩展框架210可由超弹性材料诸如镍钛诺或类似特性的合金构造。
该材料可为多种形式，诸如线状、条状、片状和/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，以形成框架构件的框架。该框架可为如本文所公开的大量形状中的任何一种，并且可通过添加合金元素(例如铂)或者通过各种其他涂层或标记带而在荧光镜透视检查下可见。细长构件218可为锥形线轴，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他材料制成。如所指出，装置200可包括用于递送的递送构型，以及用于凝块取出、血流恢复和/或碎裂保护的展开构型。为了在递送构型与展开构型之间移动，可扩展框架210可被构造成在从微导管202递送(例如从微导管释放)时自扩展到大于微导管202的管腔204的直径。在展开构型中，可扩展框架210可在微导管202的远侧端部206的远侧。夹紧式单元100可处于扩展状态和塌缩状态，如图11A-11C中更详细地讨论。在递送构型中，可扩展框架210可处于微导管202的管腔204之内。转到图2B，装置200以微导管202的管腔204内塌缩的递送构型示出。另外，夹紧式单元100可处于塌缩状态，如图11A-11C所详细讨论。
图3是示出根据本公开的各方面的移除凝块的方法的流程图。如将理解的，图3中的方法步骤可通过本文所述的示例性装置中的任一种或通过类似的装置来实现。参见如图3所概述的方法300，在步骤302中，将可扩展框架在血管内凝块附近从递送构型部署成展开构型，可扩展框架可包括一个或多个框架构件以及位于一个或多个框架构件上的一个或多个夹紧式单元。每个夹紧式单元可包括处于微导管内的塌缩状态以及微导管远侧处被构造成夹紧凝块的至少一部分的扩展状态，可扩展框架可被部署成使得一个或多个夹紧式单元与凝块接触。在步骤304中，相对于可扩展框架推进微导管的管腔，使得可扩展框架的一部分至少部分地塌缩到微导管的管腔中，并且一个或多个夹紧式单元至少部分地塌缩到微导管的管腔中。在步骤306中，在从塌缩状态移动到扩展状态的凝块夹紧状态时，与凝块的部分接触的一个或多个夹紧式单元紧缩，直至凝块的一部分被压缩在一个或多个夹紧式单元的至少一对撑条之间。除此之外或另选地，撑条构件对可操作为致动且在多个撑条构件之间从血管镊夹凝块。除此之外或另选地，撑条构件对围绕中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。在步骤308中，在使撤回微导管的一个或多个夹紧式单元紧缩的同时，撤回微导管、可扩展框架和凝块。方法300可在步骤308之后结束。在其他实施方案中，可执行根据上述示例的附加步骤。
图4A-4C示出了穿透、夹紧、捕获凝块1的示例性凝块移除装置200的特写。在图4A中，装置200以展开构型示出，其中可扩展框架210位于凝块1附近(例如，嵌入或以其他方式接触凝块)。夹紧式单元100可穿透凝块1。在图4B中，微导管202此时套在可扩展框架210和夹紧式单元100上，使得夹紧式单元100夹紧凝块1的一部分。每个夹紧式单元100提供了对凝块1及其任何碎片的增强夹持。每个夹紧式单元100可在捕获凝块中特别有利，该凝块可在凝块1的中心、远侧或近侧位置具有纤维蛋白核心。此外，在使用中，如果一个夹紧式单元100错过对一些凝块1的夹持，则其远侧的一个或多个夹紧式单元100可接合和/或夹持凝块1。在一个示例中，凝块1的一部分可夹紧在微导管202的远侧端部206与可扩展框架210之间。在图4C中，凝块1被装置200捕获。凝块1的至少一部分可由夹紧式单元100固定在微导管202的管腔204之内，该微导管此时套在可扩展框架210和夹紧式单元100上。装置200可处于递送构型。除此之外或另选地，装置200可处于展开构型的固定构型。除此之外或另选地，装置200可处于展开构型的夹紧构型。每个夹紧式单元100提供了对凝块1及其任何碎片的增强夹持。每个夹紧式单元100可在捕获凝块中特别有利，该凝块可在凝块1的中心、远侧或近侧位置具有纤维蛋白核心。此外，在使用中，如果一个夹紧式单元100错过对一些凝块1的夹持，则其远侧的一个或多个夹紧式单元100可接合和/或夹持凝块1。
图5示出示例性可扩展框架的示例性模式。示例性可扩展框架500可为螺旋状，并且包括框架构件502、远侧端部504和近侧端部506。近侧端部506可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地和/或可旋转地设置在框架构件502上。可扩展框架500可由镍钛诺或其他合适的材料构造。
图6示出示例性可扩展框架的示例性模式。示例性可扩展框架600可为双螺旋，并且包括第一框架构件602、第二框架构件604、远侧端部606和近侧端部608。第一和第二框架构件602，604可在远侧端部606和近侧端部608处彼此连接。近侧端部608可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地和/或可旋转地设置在第一和第二框架构件602，604上。可扩展框架600可由镍钛诺或其他合适的材料构造。
图7A-7B示出了示例性可扩展非管状弯曲的无创伤框架模式，其能够被致动以如在框架模式的一个或多个峰之间夹持和/或夹紧凝块或其碎片。图7A示出具有框架构件702、远侧端部704、近侧端部706的示例性可扩展框架700。波模式可由近侧端部与远侧端部之间大致一致的波长L1和波幅H1来限定。近侧端部706可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地且可旋转地设置在框架构件702上。图7B示出具有框架构件752、远侧端部754、近侧端部756的示例性可扩展框架750。波模式可由波长L2和第一波幅H2限定，该第一波幅可过渡为通常大于第一波幅H2的第二波幅H3。近侧端部756可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地且可旋转地设置在框架构件752上。示例性可扩展框架700，750可由镍钛诺或其他合适的材料构造。
图8A-8B还示出了示例性可扩展非管状框架模式，其能够被致动以如在框架模式的一个或多个峰之间夹持和/或夹紧凝块或其碎片。图8A示出具有框架构件802、远侧端部804、近侧端部806的示例性可扩展框架800。相对尖锐的非弯曲模式可由近侧端部与远侧端部之间大致一致的波长L3和波幅H4来限定。近侧端部806可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地且可旋转地设置在框架构件802上。图8B示出具有框架构件852、远侧端部854、近侧端部856的示例性可扩展框架850。该模式可由波长L4和第一波幅H5限定，该第一波幅可过渡为通常大于第一波幅H5的第二波幅H6。近侧端部756可被构造成连接到细长构件218的远侧端部219。一个或多个夹紧式单元100可以可滑动地且可旋转地设置在框架构件852上。示例性可扩展框架800，850可由镍钛诺或其他合适的材料构造。
图9示出示例性凝块移除装置900。装置900可包括位于可扩展框架210的远侧端部212处的凝块碎片收集部分902。凝块碎片收集部分902(例如远侧网、网状物等)可被构造成缠绕凝块1脱落的凝块碎片。
图10是示出根据本公开的各方面的制造凝块移除装置的方法的流程图。如将理解的，图10中的方法步骤可通过本文所述的示例性装置中的任一种或通过类似的装置来实现。参考如图10所概述的方法1000，在步骤1002中，由形状记忆合金管形成一个或多个夹紧式单元，一个或多个夹紧式单元中的每一个包括可操作为夹紧凝块的多个撑条构件，多个撑条构件围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。形成一个或多个夹紧式单元还可包括将形状记忆合金管切割成多个区段，在多个区段的一个区段中切割一种模式，将不透射线标记物附着到一个或多个夹紧式单元中的每一个，并且对夹紧式结构的多个撑条构件和一个或多个中心撑条构件进行形状设定以记忆夹紧式结构的扩展状态，一个或多个夹紧式单元中的每一个的直径在塌缩状态与扩展状态之间的比率为约1.5:1至4:1。在步骤1004中，形成可扩展框架的至少一部分，包括近侧端部和一个或多个框架构件。
形成可扩展框架的至少一部分还可包括在芯轴上构造一个或多个框架构件，至少部分地基于芯轴使一个或多个框架构件成形以记忆可扩展框架的展开构型，以及连接一个或多个框架构件以形成可扩展框架的远侧端部。在步骤1006中，将一个或多个夹紧式单元与可扩展框架的至少一部分组装在一起。将一个或多个夹紧式单元与可扩展框架的至少一部分组装在一起还可包括在一个或多个框架构件上滑动一个或多个夹紧式单元，以及连接一个或多个框架构件以形成可扩展框架的近侧端部。一个或多个夹紧式单元可选择性地以多个取向对准。方法1000可在步骤1006之后结束。在其他实施方案中，可执行根据上述示例的附加步骤。
图11A-11C示出了示例性夹紧式单元状态。夹紧式单元100的示例性扩展状态示出于图11A中。夹紧式结构110具有扩展直径D1，其可在微导管202的远侧端部206的远侧实现。夹紧式单元100的示例性塌缩状态示出于图11B中。夹紧式结构110具有塌缩直径D2，其可在微导管202的管腔204内实现。夹紧式单元100的扩展状态的示例性紧缩状态示出于图11C中。夹紧式结构110具有小于扩展直径D1但大于塌缩直径D2的直径。除此之外或另选地，直径的比率可以通过例如将扩展直径D1除以塌缩直径D2来计算。除此之外或另选地，直径的比率可以通过将塌缩直径D2除以扩展直径D1来计算。
图12A示出了具有此时以起伏边缘示出的撑条构件1202a、1204a和1206a的另一示例性夹紧式单元1200a的近距离视图。这些起伏可通过热定形、卷曲或根据需要或要求以其他方式形成而形成。图12B示出了具有各自包括一个或多个金属圈的撑条构件1202b、1204b和1206b的另一示例性夹紧式单元1200b的近距离视图。图12C示出了具有此时以相对直的非弯曲撑条构件示出的撑条构件1202c、1204c和1206c的另一示例性夹紧式单元1200c的近距离视图。图12D示出了具有各自包括一个或多个凹口或凹陷的撑条构件1202d、1204d和1206d的另一示例性夹紧式单元1200d的近距离视图。这些凹口或凹陷可通过热定形、卷曲或根据需要或要求以其他方式形成而形成。
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”可指列举值的值±20％的范围，例如“约90％”可指71％至99％的值范围。
“包含”或“含有”或“包括”或“具有”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，但不排除存在其他化合物、材料、颗粒、方法步骤，即使其他此类化合物、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。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，其他示例性实施方案包括从一个特定值和/或到另一特定值。
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他示例。本公开设想用其他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)

1.一种凝块移除装置，包括：
包括远侧端部的细长构件；和
可扩展框架，所述可扩展框架包括：
近侧端部；和
一个或多个框架构件，所述一个或多个框架构件包括可操作为可滑动且可旋转地设置在其上的一个或多个夹紧式单元，所述夹紧式单元中的每一个包括在微导管内的塌缩状态以及所述微导管的远侧可操作为镊夹凝块的至少一部分的扩展状态。
2.根据权利要求1所述的凝块移除装置，所述一个或多个夹紧式单元包括：
多个撑条构件，所述多个撑条构件可操作为致动且在所述多个撑条构件之间从血管镊夹所述凝块。
3.根据权利要求2所述的凝块移除装置，所述多个撑条构件围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。
4.根据权利要求2所述的凝块移除装置，所述一个或多个夹紧式单元中的每一个可操作为在从所述塌缩状态移动到所述扩展状态的凝块夹紧状态时镊夹所述凝块，直至所述凝块的一部分压缩在所述多个撑条构件之间。
5.根据权利要求2所述的凝块移除装置，所述一个或多个夹紧式单元中的每一个的直径在所述塌缩状态与扩展状态之间的比率为约1.5:1至4:1。
6.根据权利要求2所述的凝块移除装置，所述一个或多个夹紧式单元中的每一个包括不透射线标记物。
7.根据权利要求1所述的凝块移除装置，所述一个或多个夹紧式单元包括：
夹紧式结构，所述夹紧式结构包括多个撑条构件和一个或多个中心撑条构件；
第一轴环，所述第一轴环包括第一轴环管腔；和
第二轴环，所述第二轴环包括第二轴环管腔。
8.根据权利要求7所述的一个或多个夹紧式单元，其中一个或多个撑条构件是可操作为镊夹有凝块的至少一部分的撑条网络，所述撑条网络构造成使得在扩展状态下，所述撑条网络的至少一部分穿透所述凝块。
9.根据权利要求7所述的一个或多个夹紧式单元，其中所述第一轴环管腔和所述第二轴环管腔可操作为接纳一个或多个框架构件。
10.根据权利要求1所述的凝块移除装置，还包括：
包括远侧端部的细长构件；并且其中所述细长构件的所述远侧端部附接到所述可扩展框架的所述近侧端部。
11.根据权利要求1所述的凝块移除装置，其中所述一个或多个夹紧式单元选择性地在一个或多个框架构件上以多个取向对准。
12.根据权利要求1所述的凝块移除装置，其中所述可扩展框架通常为具有沿其长度波幅递增的波模式。
13.一种用于取出凝块的方法，所述方法包括以下步骤：
将可扩展框架在血管内且在凝块附近从递送构造部署成展开构造，所述可扩展框架包括一个或多个框架构件以及位于所述一个或多个框架构件上的一个或多个夹紧式单元，所述夹紧式单元中的每一个包括在微导管内的塌缩状态以及所述微导管的远侧构造成夹紧所述凝块的至少一部分的扩展状态，所述可扩展框架部署成使得一个或多个夹紧式单元与所述凝块接触；
相对于所述可扩展框架推进所述微导管的管腔，使得所述可扩展框架的一部分至少部分地塌缩到所述微导管的所述管腔中，并且一个或多个夹紧式单元至少部分地塌缩到所述微导管的所述管腔中；
在从所述塌缩状态移动到所述扩展状态的凝块夹紧状态时，使与所述凝块的部分接触的所述一个或多个夹紧式单元紧缩，直至所述凝块的一部分压缩在所述一个或多个夹紧式单元的至少一对撑条构件之间；以及
在使所述一个或多个夹紧式单元紧缩的同时撤回所述微导管、所述可扩展框架和所述凝块。
14.根据权利要求13所述的方法，其中所述撑条构件对可操作为致动且在所述撑条构件对之间从血管镊夹所述凝块。
15.根据权利要求14所述的方法，其中所述撑条构件对围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合。
16.一种用于制造凝块移除装置的方法，所述方法包括以下步骤：
由形状记忆合金管形成一个或多个夹紧式单元，所述一个或多个夹紧式单元中的每一个包括可操作为夹紧凝块的多个撑条构件，所述多个撑条构件围绕一个或多个中心撑条构件定位，每个撑条构件在共同的相应近侧端部和远侧端部处接合；
形成可扩展框架的至少一部分，包括：近侧端部和一个或多个框架构件；以及
将所述一个或多个夹紧式单元与所述可扩展框架的至少一部分组装。
17.根据权利要求16所述的方法，其中由形状记忆合金管形成一个或多个夹紧式单元还包括以下步骤：
将所述形状记忆合金管切割成多个区段；
在所述多个区段的一个区段中切割一种模式；
将不透射线标记物附着到所述一个或多个夹紧式单元中的每一个；以及
对夹紧式结构的多个撑条构件和一个或多个中心撑条构件进行形状设定以记忆所述夹紧式结构的扩展状态，所述一个或多个夹紧式单元中的每一个的直径在塌缩状态与所述扩展状态之间的比率为约1.5:1至4:1。
18.根据权利要求16所述的方法，其中形成所述可扩展框架的至少一部分还包括以下步骤：
在芯轴上构造一个或多个框架构件；
至少部分地基于所述芯轴使一个或多个框架构件成形，以记忆所述可扩展框架的展开构造；以及
连接一个或多个框架构件以形成所述可扩展框架的远侧端部。
19.根据权利要求16所述的方法，其中将所述一个或多个夹紧式单元与所述可扩展框架的至少一部分组装还包括以下步骤：
在一个或多个框架构件上滑动一个或多个夹紧式单元；以及
连接一个或多个框架构件以形成所述可扩展框架的近侧端部，并且
其中一个或多个夹紧式单元选择性地以多个取向对准。
20.根据权利要求16所述的方法，其中所述一个或多个夹紧式单元还包括：
第一轴环，所述第一轴环包括第一轴环管腔；
第二轴环，所述第二轴环包括第二轴环管腔；以及
其中所述第一轴环管腔和所述第二轴环管腔可操作为接纳一个或多个框架构件，并且
其中所述多个撑条构件和一个或多个中心撑条构件是可操作为与凝块的至少一部分接合的撑条网络，所述撑条网络构造成使得在扩展状态下，所述撑条网络的至少一部分穿透所述凝块。
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