CN112842463A - 具有外部护套和内部导管的凝块取回装置 - Google Patents

具有外部护套和内部导管的凝块取回装置 Download PDF

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CN112842463A
CN112842463A CN202011357242.8A CN202011357242A CN112842463A CN 112842463 A CN112842463 A CN 112842463A CN 202011357242 A CN202011357242 A CN 202011357242A CN 112842463 A CN112842463 A CN 112842463A
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outer sheath
funnel catheter
proximal
inner funnel
catheter
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B·凯西
K·基廷
R·凯莉
D·威尔
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Neuravi Ltd
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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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    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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Abstract

本发明题为“具有外部护套和内部导管的凝块取回装置”。本发明公开了一种用于取回血管中的阻塞物的装置，该装置可具有外部护套，该外部护套具有远侧端部、近侧端部、包围该近侧端部的近侧鲁尔接头以及在该远侧端部的近侧延伸并终止于该近侧鲁尔接头内的内腔；以及该外部护套内的内部漏斗导管，该内部漏斗导管包括展开远侧末端、近侧端部、位于该远侧末端处的远侧端部、包围该近侧端部的近侧鲁尔接头以及在该远侧端部的近侧延伸并终止于该鲁尔接头的内腔。外部护套和内部漏斗导管能够相对于彼此伸缩地移动。在一些示例中，位于近侧鲁尔接头中的一个近侧鲁尔接头上的滑块机构或旋钮可用于致动该相对运动。

Description

具有外部护套和内部导管的凝块取回装置
相关申请的交叉引用
本申请要求2019年11月27日提交的美国临时专利申请62/941366的优先权的权益，该美国临时专利申请全文以引用方式并入本文。
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堵塞物的装置和方法。更具体地讲，本发明涉及包括外部护套和内部漏斗导管的凝块取回装置。
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导管和装置。使用常规技术接近神经血管床尤其具有挑战性，因为目标血管直径较小，相对于插入部位而言在远端，并且是高度曲折的。传统装置通常外形太大，缺乏导航曲折血管所需的可递送性和柔韧性，难以施用和使用，或在递送至目标部位时不能有效地移除凝块。
将有效装置递送到小而高度分支的脑动脉系统依然具有挑战性，并且常规凝块取回导管存在许多缺点。首先，导管自身的直径必须足够小，以避免给患者造成显著的不适。取回导管还必须具有足够的柔韧性以导航脉管系统并承受高应变，同时还具有轴向刚度以提供沿路线的平滑推进。一旦到达目标部位，从身体中取回的典型对象的尺寸就显著大于导管末端，使得更难以将物体取回到末端中。例如，紧实的富含纤维蛋白的凝块通常难以提取，因为它们会变成为聚集在传统固定口导管的末端。另外，这种聚集可导致从凝块的较紧实区域剪切掉较软部分。
小直径和固定末端尺寸在引导手术期间移除血液和血栓材料所需的抽吸时也不太有效。抽取必须足够强效，使得因抽吸或使用机械血栓切除装置而可能发生的任何碎裂不能迁移和堵塞远侧血管。然而，当用固定口导管抽吸时，抽吸流的相当大的部分最终来自导管末端的近侧的血管流体，在该处没有凝块。这显著降低了抽吸效率，从而降低凝块去除的成功率。
试图用展开的远侧末端或结构克服这些挑战的任何导管设计都需要具有抓持凝块并在展开状态下施加稳定径向力的强度。同样的结构也需要足够的柔韧性和弹性，以承受在处于塌缩状态时导航曲折脉管系统时所赋予的严重机械应变。
此外，其它导管设计由于需要单独导管或其它部件的管理和相对定位而没有稳定它们相对于彼此的定位或有助于部件以无创伤方式的可递送性的机构，因此可给操作人员带来挑战。这可导致导管和/或装置在目标部位处的创伤性或不准确部署。
本发明的设计旨在提供解决上述缺陷的改进的取回导管。
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，希望凝块取回导管装置具有大口可展开的末端，以便移除和轻松地取回凝块，同时还具有塌缩状态，该塌缩状态为扁平的并且足够柔韧以便可递送至目标部位。该装置还应结合对现有设计的治疗管理增强以帮助管理员操作该装置。根据本发明，提供了可具有外部护套的装置，该外部护套有利于将微导管、导丝或许多可商购获得的产品中的任一种产品引入到脉管系统内的目标部位。外部护套可为导引导管和中间导管中的一者或两者。外部护套可具有远侧端部、近侧端部、包含该近侧端部的近侧鲁尔接头以及在远侧端部的近侧延伸并终止于近侧鲁尔接头内的内腔。在一些示例中，远侧端部的至少一部分可由柔性膜包围。
具有可展开的远侧末端的内部漏斗导管可位于外部护套内。可展开的远侧末端可具有由支柱或编织网片构成的支撑结构。可在将该装置施用到目标部位之前将内部漏斗导管预装载到外部护套中。
内部漏斗导管可具有近侧端部、远侧端部、包含该近侧端部的近侧鲁尔接头以及在远侧端部的近侧延伸并终止于鲁尔接头内的内腔。内部漏斗导管还可具有在鲁尔接头的近侧延伸的快速交换轴或导丝。
内部漏斗导管末端可为自展开的并且设置在内部漏斗导管的远侧端部处。末端可具有塌缩递送构型和径向展开部署构型，在该径向展开部署构型中，末端呈现基本上锥形或漏斗形状。远侧末端可被构造成在外部护套的远侧端部的远侧无约束时径向地自展开。在塌缩状态下，末端可具有小于末端的最大径向尺寸的径向尺寸。在展开时，末端可径向向外变大而形成开放远侧口。在一些示例中，末端的至少一部分可呈现比外部护套的直径更大的直径。在展开状态下，末端可接触血管的内壁并与其形成密封。
大远侧口可提供优于常规固定口设计的改善性能。传统固定口导管可能由于紧实的富含纤维蛋白的凝块聚集在末端中或由于凝块的较软部分剪切掉而受到阻碍。另外，当通过固定口导管抽吸时，抽取的相当大的部分指向末端的近侧的流体，从而减少指向凝块的抽取。另外，当可展开的末端的直径可接近于血管的直径时，可减轻导管口处的凝块剪切并且可固定末端的远侧的流体和凝块的体积。
内部漏斗导管的末端的至少一部分可具有设置在其周围的膜。在一些示例中，膜可覆盖末端和一些或全部外部护套两者。例如，膜可附接到外部护套的远侧端部并且通过远侧末端的径向自展开来径向地展开。在另一个示例中，膜可附接到内部漏斗导管的内径和外部护套的外径两者，使得膜通过远侧末端的径向自展开来径向地展开。
末端可由片材或管状不锈钢或者超弹性形状记忆合金(诸如镍钛诺)构造。在另一个示例中，末端可具有由线材或条带编织的构造。在另外的示例中，末端可为从海波管激光切割的网格。末端的形状径向尺寸可被设计成无创伤地接触血管的内壁的圆周。
在一个示例中，可将外部护套的远侧端部递送到接近目标部位。外部护套的近侧鲁尔接头可保持在固定位置以便保持外部护套的远侧端部相对于目标部位的定位。内部漏斗导管可存在于外部护套的腔内。内部漏斗导管的近侧鲁尔接头可朝远侧朝向外部护套的近侧鲁尔接头移动以将内部漏斗导管的远侧端部朝向目标部位推进。内部漏斗导管的近侧鲁尔接头还可朝近侧远离外部护套的近侧鲁尔接头移动以使内部漏斗导管远离目标部位回缩。
在一些示例中，内部漏斗导管的近侧鲁尔接头可轴向地连接到外部护套的近侧鲁尔接头。当连接时，外部护套的近侧鲁尔接头可位于漏斗导管的近侧鲁尔接头的远侧。可经由卡扣配合特征结构、鲁尔接头锁螺纹、锁定接片或其它合适的接合机构来完成鲁尔接头之间的连接。
漏斗导管的近侧鲁尔接头可包含用于改变内部漏斗导管相对于外部护套的纵向位置的机构。在一个示例中，漏斗导管的近侧鲁尔接头可包含用于使内部漏斗导管相对于外部护套的固定位置伸缩地移动的滑块机构。通过使滑块机构在漏斗导管的近侧鲁尔接头上朝远侧移动，漏斗导管可被部署为延伸经过外部护套的远侧端部。
另选地，外部护套的近侧鲁尔接头可具有用于使外部护套相对于内部漏斗导管的固定位置伸缩地移动的滑块机构。回缩滑块机构可使外部护套主体相对于漏斗导管回缩，从而允许漏斗导管的可展开的末端暴露并原位部署。在一个示例中，滑块机构可通过使用漏斗导管鲁尔接头中的滑轮拉线组来部署内部漏斗导管。另外，可将滑块在外部护套的近侧鲁尔接头上朝远侧推进，以将外部护套重新推进以包围漏斗导管的远侧端部并且使漏斗导管的可展开的末端的构型恢复到塌缩状态。
在一些示例中，可通过固定外部护套的近侧鲁尔接头的位置并且回缩漏斗导管的近侧鲁尔接头来从外部护套内撤回内部漏斗导管，从而取出内部漏斗导管。如果在移除之后替换漏斗导管，则可提供装载工具以帮助将漏斗导管重新推进穿过外部护套。装载工具可结合剖分或半剖分设计，使得其可从内部漏斗导管剥下或剥离。
在另一个示例中，可回缩外部护套的近侧鲁尔接头中的滑块机构以使外部护套相对于内部漏斗导管回缩。当外部护套回缩时，可展开的末端可露出而展开并刚好部署在目标部位的近侧。
远侧末端在推进到血管中的阻塞物期间可具有轴向地位于外部护套内的塌缩递送位置。在一些示例中，在外部护套的塌缩递送位置中外部护套的远侧端部与内部漏斗导管的远侧端部之间的距离可接近零，使得需要最小移动来部署内部漏斗导管。在另一个示例中，外部护套的远侧端部与内部漏斗导管的远侧端部之间的距离可在1mm至100mm之间的范围内，以有利于外部护套的远侧柔性。在更具体的示例中，远侧末端的塌缩递送位置是在外部护套的远侧端部的近侧大约20mm-50mm之间的距离。
在另一个示例中，用于推进或回缩外部护套相对于内部漏斗导管的位置的机构可为旋钮。旋钮的角旋转可转换成外部护套的线性运动。通过以逆时针方向或顺时针方向旋转旋钮，可相对于内部漏斗导管的位置朝远侧推进或朝近侧回缩外部护套的位置。
在一些示例中，内部漏斗导管鲁尔接头可包含用于连接注射器的端口。可在外部护套鲁尔接头与漏斗导管鲁尔接头之间提供通道，使得可经由从连接到内部漏斗导管的端口的注射器注射的流体来同时冲洗内部漏斗导管和外部护套两者。
在另一个示例中，锁定接片可将内部漏斗导管的近侧鲁尔接头连接到外部护套的近侧鲁尔接头。锁定接片可将外部护套和内部漏斗导管保持在一起以便推进。由于在推进期间外部导管的远侧端部与塌缩漏斗之间的距离一直得以保持，可在部署漏斗导管之前移除锁定接片。在已移除锁定接片之后，内部漏斗导管的近侧鲁尔接头和外部护套的近侧鲁尔接头可经由连接机构来连接。该连接机构可包括卡扣配合特征结构、鲁尔接头锁螺纹或其它接合机构。随后可使内部漏斗导管的近侧鲁尔接头和外部护套的近侧鲁尔接头断开连接，并且外部护套的近侧鲁尔接头朝远侧远离内部漏斗导管的近侧鲁尔接头移动以将内部漏斗导管收回在外部护套内。
还提供了用于从血管移除闭塞性阻塞物的方法。该方法可具有以下步骤及其变型中的一些或全部，并且这些步骤以非特定顺序列举。该方法可具有如下步骤：将外部护套推进到脉管系统中，该外部护套包括远侧端部、近侧端部和包含该近侧端部的近侧鲁尔接头；将内部漏斗导管推进穿过外部护套直到内部漏斗导管的可展开的远侧末端在外部护套的远侧端部的远侧延伸并且部署在阻塞性血栓附近，该内部漏斗导管可在外部护套内伸缩地移动并且包括近侧端部、远侧端部和包含该近侧端部的近侧鲁尔接头；将血栓捕获在内部漏斗导管的口中；以及使带有所捕获的血栓的内部漏斗导管穿过脉管系统并从患者体内取回。
当递送至目标部位时，内部漏斗导管的可展开的末端可被部署为径向自展开以便接触血管的内壁。末端的轮廓可无创伤地抵靠目标部位的近侧的血管壁密封。这可阻塞口的近侧的血管流体并提供大开口以易于接收凝块。因此，该方法还可包括用膜涂覆可展开的远侧末端的步骤。另选地，该步骤可涉及朝远侧推进远侧末端，以展开附接到外部护套的远侧端部的膜，或展开连接到漏斗导管和外部护套两者的膜。
在一个示例中，将内部漏斗导管推进穿过外部护套的步骤可包括使内部漏斗导管的近侧鲁尔接头朝远侧朝向外部护套的近侧鲁尔接头移动以将内部漏斗导管的远侧端部朝向目标部位推进。另选地，锁定机构可用于将内部漏斗导管和外部护套保持在一起以便远侧推进。在一些示例中，锁定机构可为锁定接片、卡扣配合特征结构或鲁尔接头锁螺纹中的一者。
使内部漏斗导管和外部护套相对于彼此伸缩地移动可通过利用滑动机构或旋钮来实现。在一个示例中，内部漏斗导管的近侧鲁尔接头可具有用于推进或回缩漏斗导管相对于外部护套的位置的滑块机构，并且该方法还可包括以下步骤：使滑块机构在漏斗导管的近侧鲁尔接头上朝远侧移动以将漏斗导管的远侧端部部署为延伸经过外部护套的远侧端部。
在另一个示例中，外部护套的近侧鲁尔接头可具有用于推进或回缩外部护套相对于漏斗机构的位置的滑块机构，并且该方法还可包括以下步骤：使滑块机构朝近侧回缩以暴露内部漏斗导管的末端并因此将内部漏斗导管的末端部署经过外部护套的远侧端部。
在另一个示例中，外部护套的近侧鲁尔接头可具有用于推进和回缩外部护套相对于内部漏斗导管的位置的旋钮，并且该方法还可包括以下步骤：旋转旋钮以使外部护套相对于内部漏斗导管朝近侧回缩。
将血栓捕获到凝块取回导管的口中的步骤可包括使用抽吸、血栓切除装置或本领域已知的其它实践和医疗装置。
在许多情况下，在取回一些或全部闭塞性凝块之后，可注射造影剂以允许更全面评估血管通畅的程度。如果阻塞物仍然在血管中，可使用内部漏斗导管和/或凝块取回装置进行附加道次。因此该方法还可具有在取回内部漏斗导管的同时将外部护套的位置保持在目标部位处的步骤。这可确保不丢失通向目标部位的通路以便进行后续取回尝试。然后一旦观察到目标血管的充分再通，就可从患者移除任何剩余的装置。
为了在各道次之间或在手术结束时清洁外部护套和内部漏斗导管，该方法还可具有以下步骤：同时冲洗外部护套和内部漏斗导管两者以移除聚集或松散的碎片。可在外部护套的近侧鲁尔接头与内部漏斗导管的近侧鲁尔接头之间形成多个通道以允许两者同时被冲洗。
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发明的上述及其它方面，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，相反，将重点放在示出本发明的原理。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。预期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是根据本发明的各方面的具有外部护套和内部漏斗导管的装置的图示，其中内部漏斗导管已被部署；
图2是根据本发明的各方面的处于部署位置的内部漏斗导管的末端的示例的更近视图；
图3a至图3c是根据本发明的各方面的用于取回凝块的示例性治疗装置的治疗序列的图示；
图4a至图4c示出了根据本发明的各方面的用于取回凝块的示例性治疗装置的另一个治疗序列；
图5a至图5c是根据本发明的各方面的用于取回凝块的示例性治疗装置的另一个治疗序列的视图；
图6a至图6c描绘了根据本发明的各方面的用于取回凝块的示例性治疗装置的另一个治疗序列；
图7a至图7c示出了根据本发明的各方面的用于取回凝块的示例性治疗装置的另一个治疗序列；
图8a至图8c示出了根据本发明的各方面的具有膜的另一个示例性治疗装置；
图9a至图9b是根据本发明的各方面的具有膜的另一个示例性治疗装置的图示；
图10a至图10b是根据本发明的各方面的具有膜的示例性治疗装置的视图；并且
图11是概述根据本发明的各方面的装置的使用方法的流程图。
具体实施方式
现在参考附图详细描述本发明的具体示例，其中相同的参考标号指示功能性相似或相同的元件。
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、旋转止血阀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发明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。
参见附图，在图1中示出了根据本发明的用于从患者的血管移除闭塞性凝块的装置100。装置100可具有外部护套102，该外部护套有利于将微导管、导丝或许多可商购获得的产品中的任一种产品引入到脉管系统内的目标部位。外部护套102可为导引导管和中间导管中的一者或两者。外部护套102可具有远侧端部102a、近侧端部102b、包含近侧端部102b的近侧鲁尔接头106以及在远侧端部102a的近侧延伸并终止于近侧鲁尔接头106内的内腔102c。除了引入其它装置之外，内腔还可引导从外部护套102的近侧端部102a到远侧端部102b的抽吸。外部护套102可定位在患者的脉管系统内，使得远侧端部102a靠近目标闭塞性凝块。
系统100还可具有带展开远侧末端112的内部漏斗导管104。内部漏斗导管104可位于外部护套102内。在一些示例中，内部漏斗导管与外部护套102同心，并且被构造成在外部护套内伸缩地移动。可在将装置100施用到目标部位之前将内部漏斗导管104预装载到外部护套102中。另选地，可在将外部护套102定位在患者的脉管系统内之后将内部漏斗导管104插入到外部护套102中。
内部漏斗导管可具有近侧端部104b、远侧端部104a、包含近侧端部104b的近侧鲁尔接头108以及在远侧端部104a的近侧延伸并终止于鲁尔接头108内的内腔104c。腔可由管状支撑件(诸如聚合物和/或编织构造)限定，并且可被构造成适于导丝、微导管、支架取回器和其它此类装置从中穿过。腔还可引导从内部漏斗导管的近侧端部104b到远侧末端112的抽吸。内部漏斗导管104还可具有快速交换轴或导丝，该快速交换轴或导丝在鲁尔接头108的近侧延伸以便操纵和递送内部漏斗导管104。如图2所示的远侧末端112的尺寸和构造可被设定成使得当被部署在目标部位处时，其展开以无创伤地接触内血管壁，从而提供最大可能的开口以便抽吸或以其它方式移去和接收凝块。展开的末端112还可提供流动阻滞并防止血液在末端112近侧出现不期望的抽吸。
内部漏斗导管104可独立于外部护套102来操控，并且反之亦然。内部漏斗导管104的近侧区段可具有良好推力和可跟踪性特性以帮助将其推进到目标位置，而更远侧的区段可有极高的柔性以便导航曲折解剖结构。因此内部漏斗导管104可具有多个设计或由多种材料制造，以沿着长度赋予刚度减小的轮廓，从而使插入和回缩力最小化。也可结合偏置围绕某些平面的弯曲或促进扭转以便于递送至目标部位的特征。
内部漏斗导管104可与用于移除凝块的单独机械装置(诸如血栓切除装置)结合使用。单独装置可为许多可商购获得的凝块取回产品中的任一种产品。机械装置可容纳在微导管中，该微导管可相对于内部漏斗导管104移动。微导管可设置在内部漏斗导管的腔104c内。内部漏斗导管的近侧鲁尔接头108可有利于将微导管运送到目标部位。可通过外部护套102将内部漏斗导管104、微导管和装置单独或同时递送到目标部位。一旦到达目标部位，内部漏斗导管104的末端112就可展开到部署状态。然后可从微导管部署血栓切除装置以接合和捕获闭塞性凝块，同时通过内部漏斗导管104的展开的末端112和/或外部护套102抽吸。
如图2所描绘，末端112可具有塌缩递送构型和径向展开部署构型，在该径向展开部署构型中，末端呈现基本上锥形或漏斗形状。末端112可由许多支柱140构成。在塌缩状态下，末端112可具有小于末端的最大径向尺寸的径向尺寸。当被部署时，末端112可首先在外部护套102的远侧延伸，然后径向向外变大，其中末端的至少一部分呈现比外部护套102的直径更大的直径。在展开状态下，末端112可接触血管的内壁并与其形成密封。
末端112可由片材或管状不锈钢或者超弹性形状记忆合金(诸如镍钛诺)构造。另选地，末端112可具有条带或线材的编织构造。末端112还可为从海波管激光切割的网格。末端112的径向尺寸可被设定尺寸成无创伤地接触血管的内壁的圆周。在展开时由末端112形成的漏斗形状可改善抽吸效率、减少摩擦并减小钩在血管开口上或引起血管创伤的风险。末端112的最大半径可更小、更大或为与目标血管的直径大约相同的尺寸。
该装置还可具有膜110(未示出)，该膜围绕末端112的至少一部分径向地设置。一个或多个相同或不同膜还可覆盖导管的一些或全部纵轴。
在图3a中，内部漏斗导管104被示出为在外部护套102内，其中内部漏斗导管的近侧鲁尔接头108位于外部护套的近侧鲁尔接头106的近侧。呈该构型的内部漏斗导管104和外部护套102可作为独立部件提供以便彼此结合使用。作为另选方案，内部漏斗导管104和外部护套102可按预组装状态提供。可在将装置100部署到目标部位之前将内部漏斗导管104放置到外部护套102中。图3a示出了呈约束在外部护套102内的塌缩构型的具有末端112的内部漏斗导管104。在该图中，内部漏斗导管104已以塌缩构型预装载，但内部漏斗导管104也可以以部署构型预装载。
图3b描绘了内部漏斗导管104的近侧鲁尔接头108，该近侧鲁尔接头包围内部漏斗导管的近侧端部104b，并朝远侧朝向外部护套102的近侧鲁尔接头106移动，同时外部护套的近侧鲁尔接头106保持在固定位置。该远侧移动使内部漏斗导管104朝向治疗部位并超过外部护套的远侧端部102a伸缩地移动。当内部漏斗导管104不再受外部护套102a约束时，展开远侧末端112可部署以有利于经由抽吸和/或经由微导管(未示出)递送的另一个医疗装置来移除凝块。展开的漏斗末端112可被构造成在朝外部导管末端的远侧推进到目标治疗位置时以无创伤方式在向远侧渐缩的血管中自定尺寸。
末端提供用于抽吸凝块的大远侧口并且其尺寸可被设定成直径与目标血管相比几乎相同或略大。因此，末端112可与血管密封或形成足够的限制，使得当施加抽吸时，口远侧的血液和凝块将被吸入内部漏斗导管104而不是末端近侧的血液中。如果展开的末端112不密封，或者外部或凝块取回导管与血管的内壁之间不存在其它密封件，则施加到凝块上的抽取可能无效，因为末端近侧较少限制的流动将起主导作用。
另选地，在图3b中，当外部护套的近侧鲁尔接头106朝近侧朝向内部漏斗导管的近侧鲁尔接头108移动时，内部漏斗导管104可保持在固定位置，从而回缩外部护套102并且暴露内部漏斗导管104以部署展开远侧末端112。该构型可更无创伤，因为不要求部署的漏斗的进一步朝远侧推进并且不需要完全展开的漏斗朝远侧推进穿过血管。
在图3c中，内部漏斗导管104的近侧鲁尔接头108朝近侧远离外部护套102的静态近侧鲁尔接头移动，从而引起内部漏斗导管104朝近侧往回移动到外部护套102内并且可展开的远侧末端112被约束回到塌缩构型。对于紧实或富含纤维蛋白的凝块聚集在末端中的情况而言，末端的完全重新套上可能是不可能的并且可相继撤回外部护套102和内部漏斗导管104。
图4a至图4c描绘了装置100的示例，其中滑动机构114位于内部漏斗导管104的近侧鲁尔接头108上以有利于内部漏斗导管相对于外部护套102移动。在图4a中，内部漏斗导管的近侧鲁尔接头108连接到外部护套的近侧鲁尔接头106。在将装置100施用到治疗部位之前可将内部漏斗导管的近侧鲁尔接头108和外部护套的近侧鲁尔接头106锁定在一起以便推进穿过脉管系统。可例如通过卡扣配合特征结构、鲁尔接头锁螺纹、锁定接片或其它合适的接合机构来完成鲁尔接头之间的连接。在连接的构型中，外部护套的近侧鲁尔接头106位于漏斗导管的近侧鲁尔接头108的远侧。在图4a中，内部漏斗导管104的可展开的远侧末端112呈外部护套102内的塌缩形式以便递送。
漏斗导管104的近侧鲁尔接头108的滑动机构114可与内部漏斗导管的近侧端部104b相互作用以伸缩地推进或回缩漏斗导管相对于外部护套102的位置。在图4b中，滑块机构114被描绘为已在内部漏斗导管的近侧鲁尔接头108上朝远侧移动，从而使内部漏斗导管104移动以延伸经过外部护套的远侧端部102a并且引起远侧末端112部署到展开的构型。
如图4c所描绘，可通过以下方式将内部漏斗导管104撤回到外部护套102中：回缩滑块机构114并且在拆卸并朝近侧撤回内部漏斗导管的近侧鲁尔接头108的同时将外部护套的近侧鲁尔接头106保持在固定位置。可在外部护套102保持在患者体内适当位置时移除内部漏斗导管104。如果移除了内部漏斗导管104，则外部护套102可用作抽吸导管或可保持通向目标部位的通路以便内部漏斗导管104或其它装置随后重新插入。例如，如果所捕获的凝块阻塞了内部漏斗导管的内腔104a，则外部护套可在内部漏斗导管被清洁时保持在适当位置。
至少一个止血阀(未示出)可附接到内部漏斗导管104或其鲁尔接头108和/或外部护套102和其鲁尔接头106。外部护套的近侧鲁尔接头106还可包含用于冲洗的侧面鲁尔接头或端口106a。另外，如果在移除之后替换内部漏斗导管，则可提供装载工具以帮助重新推进内部漏斗导管104穿过外部护套102。装载工具可结合剖分或半剖分设计，使得其可从内部漏斗导管104剥下或剥离。
图5a至图5c描绘了装置100的示例，其中滑动机构116位于外部护套102的近侧鲁尔接头106中或上以有利于外部护套相对于内部漏斗导管104移动。在图5a中，内部漏斗导管的近侧鲁尔接头108连接到外部护套的近侧鲁尔接头106。在将装置100推进到治疗部位之前可连接内部漏斗导管的近侧鲁尔接头108和外部护套的近侧鲁尔接头106。与其它示例一样，该连接可为卡扣配合特征结构、鲁尔接头锁螺纹、锁定接片或其它接合机构。在连接的构型中，外部护套的近侧鲁尔接头106位于漏斗导管的近侧鲁尔接头108的远侧。在图5a中，内部漏斗导管104的远侧末端112呈外部护套102内的塌缩形式。
外部护套102的近侧鲁尔接头106的滑动机构116可推进或回缩外部护套相对于内部漏斗导管114的位置。在递送期间，远侧末端112可相对于外部护套102的远侧端部102a处于塌缩递送位置。在一个示例中，外部护套的远侧端部102a与内部漏斗导管的远侧端部104a之间的距离D可接近零，使得需要最小移动来部署内部漏斗导管。在另一个示例中，外部护套的远侧端部与内部漏斗导管的远侧端部之间的递送位置的距离D可为大约1mm至100mm以保持外部护套的远侧柔性。另选地，外部护套的远侧端部与内部漏斗导管的远侧端部之间的距离可为大约20mm至50mm，使得针对该距离保持外部护套的柔性。
如图5b所描绘，通过使滑块机构116在外部护套的近侧鲁尔接头106上朝近侧回缩，可在外部护套相对于内部漏斗导管104朝近侧移动时使内部漏斗导管104的远侧末端112在目标侧处暴露于外部护套102之外。滑块机构116可与漏斗导管鲁尔接头108中的滑轮拉线组或类似关节运动机构相互作用。还可在外部护套的近侧鲁尔接头106上朝远侧推进滑块机构116以重新套上漏斗导管的远侧端部104a并使内部漏斗导管104的远侧末端112塌缩。
图5b的构型允许内部漏斗导管104被原位部署，这改善了相对于目标部位的部署准确性并且可形成更无创伤的血管相互作用，因为展开末端112未朝远侧朝向目标部位推进。
图5c描绘了可通过以下方式从外部护套102撤回内部漏斗导管104：将外部护套的近侧鲁尔接头106保持在固定位置并且拆卸和回缩内部漏斗导管的近侧鲁尔接头108。可移除内部漏斗导管104，同时外部护套102保持在适当位置，从而允许外部护套102用作抽吸导管并且保持通向目标部位的通路。外部护套的近侧鲁尔接头106还可包含用于冲洗的侧面鲁尔接头106a。
图6a至图6c描绘了装置100的示例，其中旋钮118位于外部护套的近侧鲁尔接头106上以有利于外部护套102相对于内部漏斗导管104移动。在图6a中，当旋转旋钮118时，旋钮可与外部护套102的近侧端部102b相互作用以便以伸缩方式使外部护套相对于内部漏斗导管104朝远侧推进或朝近侧回缩。应当理解，还可在内部漏斗导管的鲁尔接头上使用旋转鲁尔接头装置以相对于外部护套延伸或缩短其长度。
对于在内部导管与外部导管之间包括长行程的装置而言，旋钮118机构的使用可使鲁尔接头106的长度最小化。装置100的总长度应在普遍可得的导管的范围内，使得装置100可与普遍可得的球囊导引管、中间导管、微导管和类似装置一起使用。例如，为了与球囊导引管一起使用，装置100可具有大约80cm至100cm的长度。为了与中间导管一起使用，装置100可具有大约120cm至140cm的长度。为了与微导管一起使用，装置100可具有130cm与160cm之间的长度。类似地，根据手术的性质，可预期其它长度。
内部漏斗导管鲁尔接头108可包含用于连接注射器或另一种流体或真空源的端口。可在外部护套鲁尔接头106与漏斗导管鲁尔接头108之间提供多个通道，使得可经由注射到内部漏斗导管104的端口中的流体来同时冲洗内部漏斗导管104和外部护套102两者。
如图6b所描绘，旋转旋钮118可回缩外部护套102以在目标部位处露出内部漏斗导管104。外部护套102可通过旋钮机构118来相对于内部漏斗导管104朝近侧移动，从而允许内部漏斗导管的部署。还可在相反方向上旋转旋钮机构118以重新包围漏斗导管的远侧端部104a并且重新套上内部漏斗导管104的展开末端112。
图6c描绘了可通过以下方式从外部护套102撤回内部漏斗导管104：将外部护套的近侧鲁尔接头106保持在固定位置并且拆卸和回缩内部漏斗导管的近侧鲁尔接头108。与其它示例类似，可移除内部漏斗导管104，同时外部护套102保持在适当位置以用作抽吸导管并且保持通向目标部位的通路。
图7a至图7c描绘了装置100的示例，其中锁定接片134位于外部护套102的近侧鲁尔接头106与内部漏斗导管104的近侧鲁尔接头108之间。如图7b所描绘，可移除锁定接片134。外部护套的近侧鲁尔接头106可朝近侧朝向内部漏斗导管的近侧鲁尔接头108移动以使外部护套102相对于内部漏斗导管104的位置回缩。锁定接片134允许两个导管102、104在运送、灭菌和推进穿过血管床期间相对于彼此保持静态。在已移除锁定接片之后，外部护套和内部漏斗导管能够相对于彼此平移。可提供连接机构以允许鲁尔接头在手术期间暂时连接。该连接机构可包括如图7c所描绘的卡扣配合特征结构130、鲁尔接头锁螺纹或其它接合机构。一旦到达凝块，就可如图所示的那样部署展开远侧末端112并且卡扣配合特征结构130可将部署的内部漏斗导管104锁定在适当位置。
如图7c所描绘，随后可通过克服卡扣配合130力来使内部漏斗导管的近侧鲁尔接头108和外部护套的近侧鲁尔接头106断开连接。然后可通过以下方式将内部漏斗导管104撤回到外部护套102中：将外部护套的近侧鲁尔接头106保持在固定位置并且拆卸和回缩内部漏斗导管的近侧鲁尔接头108。与其它示例一样，至少一个止血阀可附接到内部漏斗导管104或其鲁尔接头108和/或外部护套102或其鲁尔接头106。
图8a至图8c是根据本发明的各方面的具有膜的示例性治疗装置的图示。在一些示例中，末端112可由膜110覆盖。当末端112被完全部署时，末端的支柱可将膜表面径向地拉伸成弯曲增加的漏斗状轮廓。
膜110可采用多种不同的形式或构型。膜110可使用高弹性材料形成为管状轮廓，使得末端112的展开将赋予足够的径向力以在无约束时将膜110拉伸成末端112的轮廓。膜110可为例如低模量弹性体。弹性体膜110可形成温和接触表面以便在末端112被部署为展开的构型时抵靠血管壁密封。在另一个示例中，可形成膜110以在外表面上包括软弹性体或凝胶肋，从而提供与血管壁的无创伤接触。该密封件可通过使抽取集中在远侧并且限制末端近侧的没有凝块的流体被吸入导管中来实现更有效的抽吸。
如果从海波管切下末端112，则可在海波管的外表面中激光切割出空间、狭槽或图案并且可在制造期间使膜110回流或注射模塑到这些空间中。可使用热量将膜110粘附到末端112的支柱140。可修改诸如浸入停留时间、基底撤回速度、温度、湿度和循环数的所有要素以便为膜110赋予期望且均匀的轮廓。另选地，可将松散或松垂的膜110放置在末端的口上方。
如图8a所描绘，膜110可附接到展开远侧末端112并且还可附接到末端近侧的一些或全部导管轴。膜还可在部署状态下包封在框架上方，使得其被压缩以便递送并且在展开时恢复到其初始形状。可对膜110使用弹性体材料或在塌缩到外部导管中时不会超过其弹性应变极限的材料。
如图8b所描绘，膜110可包封展开末端112，使得在展开时膜100可在末端112的支柱之间拉伸。另选地，如图8c所描绘，膜110可形成为管并且翻转以从末端112内部朝远侧折叠并围绕末端112翻转以沿着末端112的外表面朝近侧延伸。图8c所描绘的构型并未以填隙方式完全包封末端112，因此允许末端112的结构在膜盖110内自由地展开。从而图8c所描绘的膜构型减小了展开膜所需的应变并且减小了末端112展开所需的径向力。
图9a至图9b是根据本发明的各方面的具有膜的另一个示例性治疗装置的图示。在图9a中，膜110可附接到外部护套102a的远侧端部。膜可具有渐缩或减小的外径OD，这有助于将装置100无创伤地推进穿过脉管系统。根据图3a至图3c、图4a至图4c、图5a至图5c、图6a至图6c或图7a至图7c，可操作装置100以便以将内部漏斗导管的可展开的末端112刚好部署在目标部位的近侧的任何方式使内部漏斗导管104相对于外部护套102朝远侧移动或使外部护套102相对于内部漏斗导管104朝近侧移动。图9a描绘了呈与图5a至图5c类似的构型的、具有外部护套机构滑块116的装置。通过利用滑块机构116，可使内部漏斗导管104朝远侧移动以按压到膜110中，或可使外部护套102相对于内部漏斗导管104朝近侧移动。当无约束时，末端112张开到膜110中并且展开，继而引起膜110展开，如图9b中所见。如上所述，膜110可为弹性体或松垂的。
图10a至图10b是根据本发明的各方面的具有膜的另外一个示例性治疗装置的图示。在图10a中，膜110附接到外部护套102a的远侧端部和内部漏斗导管104的内表面。膜110从内部漏斗导管104的内径ID延伸并且围绕外径OD翻转以连接到外部护套102。与先前描述的示例一样，可操作装置100以便以部署内部漏斗导管的可展开的末端112的任何方式使内部漏斗导管104相对于外部护套102朝远侧移动或使外部护套102相对于内部漏斗导管104朝近侧移动。图10a描绘了呈与图5a至图5c类似的构型的、具有外部护套滑块机构116的装置。当推进内部漏斗导管104和/或回缩外部护套时，膜110随末端112一起移动并且展开。在图10b所示的构型中，内部漏斗导管104的外部框架按压在外部护套102的内表面上而非按压在膜上，从而在递送和展开时减少摩擦。
图11描绘了概述该装置的使用方法的流程图。该方法可具有以下步骤及其变型中的一些或全部，并且这些步骤以非特定顺序列举。方法1100可具有如下步骤：将外部护套推进到脉管系统中，该外部护套包括远侧端部、近侧端部和包含该近侧端部的近侧鲁尔接头(1110)；将内部漏斗导管推进穿过外部护套直到内部漏斗导管的可展开的远侧末端在外部护套的远侧端部的远侧延伸并且部署在阻塞性血栓附近，内部漏斗导管包括近侧端部、远侧端部和包含近侧端部的近侧鲁尔接头(1120)；将血栓捕获在内部漏斗导管的口中(1130)；以及使带有所捕获的血栓的内部漏斗导管穿过脉管系统并从患者体内取回(1140)。
应当理解，可将外部护套和内部漏斗导管一起或单独地推进到目标部位。例如，该方法可涉及将内部漏斗导管预装载到外部护套中。然后可冲洗该系统并且将该系统推进到目标部位。为便于同时推进到目标部位，锁定机构可将内部漏斗导管和外部护套保持在一起。该机构可为例如锁定接片、卡扣配合特征结构或鲁尔接头锁螺纹中的一者。当递送至目标部位时，内部漏斗导管的可展开的末端可被部署为径向展开以便接触血管的内壁。末端的轮廓可抵靠目标部位近侧的血管壁密封。这密封了口近侧的血管流体并提供大开口以易于接收凝块。
该方法可具有用膜覆盖可展开的远侧末端的步骤。在另选示例中，朝远侧推进末端可展开附接到外部护套的远侧端部的膜。在另外的示例中，膜可连接到漏斗导管的内径和外部护套的外径。
在一些示例中，推进内部漏斗导管穿过外部护套的步骤可涉及使内部漏斗导管的近侧鲁尔接头朝远侧朝向外部护套的近侧鲁尔接头移动以将内部漏斗导管的远侧端部朝向目标部位推进。
可通过机构来使外部护套和内部漏斗导管相对于彼此伸缩地移动，其中该机构可为滑块或旋钮。在一个示例中，内部漏斗导管的近侧鲁尔接头可容纳用于推进或回缩漏斗导管相对于外部护套的位置的滑块机构，并且该方法还可包括以下步骤：使滑块机构在漏斗导管的近侧鲁尔接头上朝远侧移动以将漏斗导管的远侧端部部署为延伸超过外部护套的远侧端部。
在另一个示例中，外部护套的近侧鲁尔接头可具有用于推进或回缩外部护套相对于内部漏斗导管的位置的滑块机构，并且该方法还可包括以下步骤：使滑块机构朝近侧回缩以暴露内部漏斗导管的末端并因此将内部漏斗导管的末端部署超过外部护套的远侧端部。
在另外的示例中，外部护套的近侧鲁尔接头可具有用于推进和回缩外部护套相对于内部漏斗导管的位置的旋钮，并且该方法还可包括以下步骤：旋转旋钮以使外部护套相对于内部漏斗导管朝近侧回缩以暴露可展开的末端。重新套上末端可涉及在相反方向上旋转旋钮的步骤。
将血栓捕获到凝块取回导管的口中的步骤可涉及使用抽吸、血栓切除装置或本领域已知的其它装置和实践。当取回血栓时，该方法还可具有以下步骤：将外部护套的位置保持在目标部位处以用作抽吸导管并且在撤回内部漏斗导管和所捕获的凝块时保持通向目标部位的通路。可注射造影剂以检查血管通畅性，并且如果仍有堵塞物，可通过外部护套引导抽吸。还可重新推进内部漏斗导管以便抽吸。然后可将外部护套和内部漏斗导管一起或单独地移除。
在一些情况下，如果血管不通畅，可需要用该装置进行附加道次。在各道次之间，可能有必要从内部漏斗导管和外部护套的腔清洁凝块碎片和/或碎屑。该装置的近侧鲁尔接头中的一者或两者可具有用于冲洗的端口，并且在一些情况下可在外部护套的近侧鲁尔接头与内部漏斗导管的近侧鲁尔接头之间形成多个通道。然后该方法还可具有以下步骤：使用这些通道同时冲洗内部漏斗导管和外部护套。
本发明不必限于所描述的示例，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。此外，除非上下文另有明确说明，否则单数形式“一个”、“一种”和“该/所述”包括复数指代。
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。
在描述示例实施方案时，为了清楚起见，采用了术语。在不脱离本发明的范围和精神的情况下，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。类似地，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一些步骤。为清楚和简洁起见，并未列出所有可能的组合，并且此类变型形式对于本领域技术人员而言通常是显而易见的，并且旨在落入以下权利要求书的范围内。

Claims (20)

1.一种用于取得血管中的阻塞物的装置，所述装置包括：
外护套，所述外护套包括远侧端部、近侧端部、包围所述近侧端部的近侧鲁尔接头，以及在所述远侧端部的近侧延伸且终止于所述近侧鲁尔接头内的内腔；以及
内漏斗导管，所述内漏斗导管在所述外护套内，所述内漏斗导管包括展开的远侧末端、近侧端部、位于所述远侧末端处的远侧端部、包围所述近侧端部的近侧鲁尔接头，以及在所述远侧端部的近侧延伸且终止于所述鲁尔接头处的内腔；
所述展开的远侧末端构造成在所述外护套的所述远侧端部的远侧无约束时径向地自展开。
2.根据权利要求1所述的装置，其特征在于，所述装置还包括用于使所述内漏斗导管相对于所述外护套的固定位置伸缩移动的滑块机构。
3.根据权利要求2所述的装置，其特征在于，所述滑块机构定位在所述内漏斗导管的所述近侧鲁尔接头上。
4.根据权利要求1所述的装置，其特征在于，所述装置还包括旋钮，所述旋钮构造成用于使所述外护套相对于所述内漏斗导管的固定位置伸缩移动。
5.根据权利要求1所述的装置，其特征在于，所述装置还包括用于使所述外护套相对于所述内漏斗导管的固定位置伸缩移动的滑块机构。
6.根据权利要求5所述的装置，其特征在于，所述滑块机构定位在所述外护套的所述近侧鲁尔接头上。
7.根据权利要求1所述的装置，其特征在于，所述装置还包括锁定接片，所述锁定接片定位在所述内漏斗导管的所述近侧鲁尔接头与所述外护套的所述近侧鲁尔接头之间。
8.根据权利要求1所述的装置，其特征在于，所述装置还包括所述内漏斗导管的所述近侧鲁尔接头与所述外护套的所述近侧鲁尔接头之间的卡扣配合连接。
9.根据权利要求1所述的装置，其特征在于，所述远侧末端至少部分地由膜包封。
10.根据权利要求1所述的装置，其特征在于，附接到所述外护套的所述远侧端部的膜通过所述远侧末端的径向自展开来径向地展开。
11.根据权利要求1所述的装置，其特征在于，附接到所述内漏斗导管的内径和所述外护套的外径的膜通过所述远侧末端的径向自展开来径向地展开。
12.根据权利要求1所述的装置，其特征在于，所述远侧末端在推进到所述血管中的所述阻塞物期间处于所述外护套内的塌缩递送位置。
13.根据权利要求12所述的装置，其特征在于，所述远侧末端的所述塌缩递送位置是在所述外护套的所述远侧端部的近侧大约20mm-50mm之间的距离。
14.一种从患者的血管取得阻塞性血栓的方法，所述方法包括以下步骤：
将外护套推进到脉管系统中，所述外护套包括远侧端部、近侧端部和包含所述近侧端部的近侧鲁尔接头；
使连接到所述外护套且能够在所述外护套内伸缩移动的内漏斗导管推进穿过所述外护套直到所述内漏斗导管的可展开的远侧末端在所述外护套的所述远侧端部的远侧延伸且部署在与所述阻塞性血栓相邻的目标部位处，所述内漏斗导管包括近侧端部、远侧端部和包含所述近侧端部的近侧鲁尔接头；
在所述内漏斗导管的口中捕获所述血栓；以及
使带有所捕获的血栓的所述内漏斗导管穿过所述脉管系统且从所述患者中取得。
15.根据权利要求14所述的方法，其特征在于，所述方法还包括在取得所述内漏斗导管的同时将所述外护套的位置保持在所述目标部位处。
16.根据权利要求14所述的方法，其特征在于，所述方法还包括朝远侧推进所述远侧末端以展开附接到所述外护套的所述远侧端部的膜。
17.根据权利要求14所述的方法，其特征在于，所述方法还包括通过机构来使所述内漏斗导管和所述外护套相对于彼此伸缩移动；
其中所述机构是滑动机构或旋钮中的一者。
18.根据权利要求14所述的方法，其特征在于，所述方法还包括通过在所述外护套的所述近侧鲁尔接头与所述内漏斗导管的所述近侧鲁尔接头之间形成的多个通道来同时冲洗所述外护套和所述内漏斗导管两者。
19.根据权利要求14所述的方法，其特征在于，所述方法还包括通过锁定机构来将所述内漏斗导管和所述外护套保持在一起以便远侧推进。
20.根据权利要求19所述的方法，其特征在于，所述锁定机构是锁定接片、卡扣配合特征结构或鲁尔接头锁螺纹中的一者。
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US20210154433A1 (en) 2021-05-27
EP3827763B1 (en) 2024-03-27
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EP3827763A1 (en) 2021-06-02
US11839725B2 (en) 2023-12-12

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