CN113855166A - 具有柔性编织物区段的植入式医疗装置分离系统 - Google Patents

具有柔性编织物区段的植入式医疗装置分离系统 Download PDF

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CN113855166A
CN113855166A CN202110752079.3A CN202110752079A CN113855166A CN 113855166 A CN113855166 A CN 113855166A CN 202110752079 A CN202110752079 A CN 202110752079A CN 113855166 A CN113855166 A CN 113855166A
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tube
medical device
distal
implantable medical
proximal
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M·克林杰
K·约翰逊
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DePuy Synthes Products Inc
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Abstract

本发明题为“具有柔性编织物区段的植入式医疗装置分离系统”。所公开的技术包括用于将植入式医疗装置递送到身体血管的目标位置的分离系统，该分离系统包括近侧递送管、远侧递送管和设置在两者间的编织物区段。远侧管包括近侧端部、远侧端部和位于近侧端部与远侧端部之间的管本身的可压缩部分，该可压缩部分可从压缩状态轴向移动到伸长状态。近侧管具有近侧端部和远侧端部。编织物区段由多根线形成。接合系统接合并部署接合在远侧管的远侧端部处的植入式医疗装置。

Description

具有柔性编织物区段的植入式医疗装置分离系统
技术领域
本发明整体涉及能够导航穿过人类受试者的身体血管的介入式医疗装置系统。更具体地，本发明涉及用于将植入式医疗装置递送和部署到身体血管的目标位置的分离系统以及该分离系统的使用方法。
背景技术
使用导管递送系统在人体的脉管系统中定位和部署治疗装置诸如膨胀气囊、支架和栓塞性线圈已成为治疗血管内疾病的标准规程。已经发现，这种装置特别适用于治疗传统操作规程不可能或对患者构成巨大风险的区，例如在颅内血管中的动脉瘤的治疗中。由于颅内血管周围的组织(特别是例如脑组织)较脆弱，进行外科手术治疗颅内血管的缺陷非常困难，而且常常有风险。在此类情况下，对导管部署系统的改进提供了替代治疗方案。导管递送系统的一些优点是，它们提供了通过已经发现的减少对周围组织的创伤风险的方式来治疗血管的方法，并且它们还允许治疗过去被认为不能动手术的血管。
通常，使用导管部署系统治疗动脉瘤的规程涉及将递送导管的远侧端部插入患者的脉管系统中并引导递送导管穿过脉管系统到达预先确定的递送部位。血管闭塞装置诸如栓塞性线圈可以在递送构件(例如，微导管)的远侧端部处附接到植入物接合/递送系统，该递送构件推动线圈穿过递送导管并从递送导管的远侧端部出来进入递送部位。美国专利公布号2019/0192162A1、美国专利公布号2019/0328398A1和美国专利公布号2021/0001082A1中描述了示例性递送构件和接合/递送系统，上述文献中的每一者以引用方式并入本文。
许多基于导管的植入物递送系统可包括延伸穿过导管的一个或多个内部伸长构件，这些内部伸长构件可由医师在近侧端部处操纵以部署植入式装置。内部伸长构件可将植入式装置保持在导管中，直到用于释放植入物的时间为止。这些系统可通过相对于导管回缩或牵拉伸长构件来致动。与正确执行这种动脉瘤治疗规程相关联的一些挑战包括确保递送构件和接合系统在整个治疗过程中保持在稳定的位置。例如，在一些动脉瘤治疗应用中，随着动脉瘤越来越多地被栓塞性材料填充，递送构件可能由于来自被植入的栓塞材料的增加的回推而倾向于移位。如果递送构件在治疗期间发生移位，则医师可能无法准确地控制栓塞性材料的放置，并且可能选择停止填塞动脉瘤。在此类示例中，动脉瘤可能没有被充分填塞，这可能导致再通。此外，递送构件和/或其上的接合系统的过度移动或拉伸会导致栓塞性线圈的过早脱离。降低过早释放的可能性的方法的一些示例可导致柔性较小的机械释放系统。
另外，导管部署系统可用于治疗与颅内动脉粥样硬化疾病(ICAD)相关联的血管内病变。在一些情况下，血管内病变可能不够软，无法使支架取栓器有效地接合血管并从血管移除病变。在这种情况下，可能希望部署支架，使得可通过支架植入术治疗血管内病变。在递送任一装置之前，医师可能不知道是通过支架还是支架取栓器更好地治疗病变。由于支架取栓器是可回缩的并且支架通常不是可回缩的，因此在此类情况下，支架取栓器通常在第一次穿过时部署，然后在第二次穿过时部署支架(如果合适的话)。多次穿过脉管系统可增大对脉管系统的创伤并增加治疗时间，从而增大并发症的可能性。
因此，需要可降低血管内治疗装置过早部署的可能性、同时还提供柔性机械释放系统的系统、装置和方法。
发明内容
一般来讲，本发明的目的是提供一种用于将植入式医疗装置递送到身体血管的目标位置的分离系统，该分离系统包括近侧递送管、远侧递送管和设置在两者间的编织物区段。编织物区段在植入式装置部署在动脉瘤中期间提供稳定性，同时使分离系统的柔性最大化。
用于将植入式医疗装置递送到血管的目标位置的示例性分离系统可包括大致中空的近侧管、大致中空的远侧管、编织物区段和接合系统。近侧管可包括近侧端部和远侧端部。远侧管可包括近侧端部、远侧端部和远侧管本身的可压缩部分，该可压缩部分能够从压缩状态轴向移动到伸长状态。编织物区段可设置在远侧管的近侧端部与近侧管的远侧端部之间。编织物区段可由多根线形成。接合系统可被构造成接合并部署设置在远侧管的远侧端部处的植入式医疗装置。
编织物区段可围绕聚合物内衬同心地设置。
聚合物套管可定位在近侧管、编织物区段以及远侧管的至少一部分上。
聚合物套管可包括一个或多个亲水性涂层。
聚合物套管可具有厚度介于约0.02毫米和约0.08毫米之间的壁。
编织物区段可包括介于约8个和约16个之间的线段。
编织物区段可被构造成具有介于约50和约100之间的每英寸纬数。
远侧管的可压缩部分可为远侧管的螺旋切割部分。
接合系统可被构造成在接合植入式医疗装置时将可压缩部分移动到压缩状态并且在将可压缩部分释放到伸长状态时部署植入式医疗装置。
当接合系统与植入式医疗装置脱离接合时，可压缩部分可适于自动移动到伸长状态。
在一个示例中，植入式医疗装置在接合到接合系统时可为支架取栓器，该支架取栓器具有被接合系统塌缩的近侧端部和被接合系统塌缩的远侧端部。植入式医疗装置在与接合系统脱离接合时可为支架，该支架具有开口近侧端部和开口远侧端部。
分离植入式医疗装置的示例性方法可包括以非特定顺序呈现的以下步骤中的一个或多个步骤。该方法还可包括如本领域的普通技术人员根据本公开的教导内容所了解和理解的另外步骤。
该方法可包括在远侧管上形成可压缩部分；在近侧管上形成柔性部分；将编织物区段附接到近侧管的远侧端部和远侧管的近侧端部；以及使植入式医疗装置与接合系统接合。
该方法还可包括使聚合物套管在近侧管、编织物区段以及远侧管的至少一部分上滑动。
该方法还可包括将聚合物套管接合到植入式医疗装置。
该方法还可包括用一个或多个亲水性涂层涂覆聚合物套管。
该方法可包括围绕聚合物内衬包裹编织物区段，之后再将编织物区段附接到近侧管的远侧端部和远侧管的近侧端部。
接合步骤可包括使用带有锁定构件的环线来接合植入式医疗装置，以及向环线施加力以将可压缩部分移动到压缩状态。
该方法还可包括对锁定构件施加力，使植入式医疗装置脱离接合，以及允许可压缩部分返回到伸长状态。
该方法可包括通过将可压缩部分移动到伸长状态来部署所接合的植入式医疗装置。
在一个示例中，植入式医疗装置可为支架取栓器，该支架取栓器被构造成在部署时展开以并置血管壁。
附图说明
将参考下面的描述并结合附图进一步讨论本发明的上述方面和另外的方面，在这些附图中，类似的编号指示各种图中类似的结构元件和特征部。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。
图1A是根据本发明的各方面的具有编织物区段的示例性分离系统的图示，并且图1B是根据本发明的各方面的图1A的示例性分离系统的剖视图；
图2A是根据本发明的各方面的具有编织物区段的另外示例性分离系统的图示；
图2B是根据本发明的各方面的图2A的示例性分离系统的剖视图；
图3A是根据本发明的各方面的另外示例性分离系统的图示；
图3B是根据本发明的各方面的图3A的示例性分离系统的剖视图；
图4A是根据本发明的各方面的环线的示例的侧透视图；
图4B是根据本发明的各方面的环线的示例的平面图；
图4C是根据本发明的各方面的处于上翻状态的环线的开口的后透视细部图；
图5A至图5D是根据本发明的各方面的分离的示例性植入式医疗装置的一系列图示；
图6A至图6C是根据本发明的各方面的作为植入式医疗装置的示例性支架取栓器的部署的一系列图示；
图7A至图7B是根据本发明的各方面的分离的示例性支架取栓器的一系列图示；
图8A至图8C是根据本发明的各方面的附接到部署系统(图8A)、为横截面(图8B)以及与部署系统(图8C)分离的另外示例性支架取栓器的图示；
图9是根据本发明的各方面的处于压缩和展开状态的远侧管的示例的侧视图；并且
图10是概述了根据本发明的各方面的分离植入式医疗装置的步骤的流程图。
具体实施方式
血管内治疗诸如动脉瘤治疗中的关键成功因素是分离装置(例如，微导管)在植入物或其他医学治疗装置的部署期间保持稳定。在血管内治疗期间，在植入物被放置在动脉瘤或其他治疗部位中时，分离装置的远侧部分缺乏柔性可导致分离装置从治疗部位拉回或以其他方式移出位置。因此，具有更柔性的远侧部分的分离装置可提供用于在神经血管解剖结构中递送医疗装置以及用于面临类似挑战的其他应用的稳定系统。然而，柔性结构在导航曲折的解剖结构时可能趋于变形、延伸或扩张。分离系统的变形可抑制分离系统导航至治疗部位和/或有效部署医疗装置的能力。分离系统的伸长可导致医疗装置的过早部署。本发明的目的是提供一种具有高度柔性的编织区段的分离系统，该编织区段在医学治疗装置的递送和部署过程中抗拉伸并且结构稳定。
尽管本文详细解释了所公开技术的示例实施方案，但是应当理解可以设想其他实施方案。因此，并不意图将所公开技术的范围限制在以下描述中阐述的或附图中所示的部件的构造和布置的细节。所公开技术能够具有其他实施方案并且能够以各种方式实践或实施。
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。所谓“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。
在描述示例实施方案时，为了清楚起见，将采用术语。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，可以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，脉管系统可以是任何“受试者”或“患者”(包括任何人或动物)的脉管系统。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征的实验动物(例如，大鼠、狗、猪、猴等)。应当理解，受试者可以是例如任何适用的人类患者。
如本文所讨论的，针对任何数值或范围的术语“约”或“大约”指示允许零件或部件的集合实现其如本文所述的预期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。
附图示出了根据本发明的大致中空或管状的结构。当在本文中使用时，术语“管状”和“管”应广义地理解，并且不限于为正圆柱体的或横截面为完全圆周的或在其整个长度上具有均匀横截面的结构。例如，管状结构或系统通常被示出为基本上呈正圆柱体的结构。然而，在不脱离本发明范围的情况下，管状系统可具有锥形或弯曲外表面。
图1A至图3B示出了分离系统10的示例，其中该分离系统在本文中被公开并解决了先前方法的这些缺点和其他缺点。分离系统10可包括近侧递送管100和远侧递送管300。编织物区段200a、200b、200c可设置在近侧递送管100与远侧递送管300之间。编织物区段200a、200b、200c可由多根线202形成。可围绕聚合物内衬204包裹编织物区段200b，以最小化递送分离件10时的摩擦并保护编织物区段200b。聚合物套管206可设置在编织物区段200c上，以进一步最小化摩擦并保护编织物区段200c。编织物区段200a、200b、200c使得分离系统10在植入式医疗装置12的部署期间保持稳定，同时还提供足够的柔性，该柔性使得当植入式医疗装置定位在动脉瘤中时将分离系统10移动或拉回位置的可能性最小化。
本发明的分离系统10的示例(如图1A至图3B所示)可具有近侧伸长递送管100、编织物区段200a、200b、200c和远侧递送管300。植入式医疗装置12可在远侧递送管300的远侧端部304处接合。植入式医疗装置12可为栓塞性线圈。植入式医疗装置12可为支架取栓器612(如图6A、图6B、图7A、图7B、图8A至图8C所示)、它们的另选形式或它们的变型。尽管植入式医疗装置12在本文中被示出为栓塞性线圈或支架取栓器612，但应当理解，事实上任何植入式医疗装置12均可由根据本发明的分离系统10递送和部署。可使用锁定构件140和环线400将植入式医疗装置12接合到分离系统10。植入式医疗装置12可具有锁定部分18以与接合系统140、400连接。
近侧递送管100可具有近侧端部部分102、远侧端部部分104和柔性部分106。柔性部分106可设置在近侧端部部分102与远侧端部部分104之间。近侧递送管100可在其中具有轴向管腔。远侧递送管300可具有近侧端部部分302、远侧端部部分304和可压缩部分306。可压缩部分306可设置在近侧端部部分302与远侧端部部分304之间。可压缩部分306可更靠近远侧端部部分304。远侧递送管300可在其中形成轴向管腔。
递送管100、300可由生物相容性材料诸如不锈钢制成。管100、300可具有介于约0.25毫米(0.010英寸)和约0.46毫米(0.018英寸)之间的直径。在一个示例中，递送管可具有约0.37毫米(0.0145英寸)的直径。管尺寸的这些示例适于将栓塞线圈递送和部署到神经脉管系统内的目标位置(通常为动脉瘤)。可以设想，由其他材料构成的不同尺寸的管100、300可用于不同的应用，并且在本发明的范围内。
近侧递送管100的柔性部分106可允许近侧递送管100弯曲和挠曲。这种能力可有助于跟踪穿过导管的分离系统10和穿过人脉管系统的曲折路径。柔性部分106可形成有干涉螺旋切口。这些切口可允许有间隙以允许弯曲，但在一个示例中，不用作螺旋切割弹簧。在该构型中，干涉螺旋切口可弯曲和挠曲，但不压缩。
可压缩部分306能够在伸长状态和压缩状态之间轴向调节。可压缩部分306可由远侧管300的通过激光切割操作形成的螺旋切割部分形成。然而，可以设想，允许轴向调节的任何其他布置(例如，缠绕线或螺旋带)也适合与根据本发明的分离系统一起使用。除非另有限制，否则可压缩部分306可在静止时处于伸长状态并且从压缩状态自动地或弹性地返回到伸长状态。分离装置10可包括环线400，该环线与锁定构件140一起被构造成将植入物12固定到分离装置10。当环线400和锁定构件140接合到植入物12时，可通过环线400中的张力将可压缩部分306保持在压缩状态。环线400可在远侧管300的近侧端部302附近附连到远侧管300。
编织物区段200a、200b、200c可设置在远侧管300的近侧端部302与近侧管100的远侧端部104之间。编织物区段200a、200b、200c可附连到远侧管300的近侧端部302和近侧管100的远侧端部104。编织物区段200a、200b、200c可使用任何附接机构(包括但不限于粘合剂、焊接等)附连到远侧管300的近侧端部302和近侧管100的远侧端部104。近侧管100可延伸分离系统10的长度的大部分，而编织物区段200a、200b、200c和远侧管300可在分离系统的最远侧部分上延伸。在一个示例中，编织物区段200a、200b、200c和远侧管300可在分离系统10的最远侧500毫米上延伸。
编织物区段200a、200b、200c可由多根线202形成。多根线202可由生物相容性材料诸如不锈钢或镍钛诺制成。多根线202可包括圆线。另选地或除此之外，多根线202可包括扁线。多根线202可包括介于约6根线至约20根线之间。编织物区段200a、200b、200c可被构造成每英寸具有各种纬数。在一个示例中，编织物区段200a、200b、200c可被构造成介于约50纬/英寸至约100纬/英寸之间。当中空构件弯曲时，多根线202中的线数量和每英寸纬数可导致编织物区段200a、200b、200c在扭结之前具有减小的横截面尺寸。通过减小横截面尺寸，编织物区段200a、200b、200c可为基本上椭圆形的。多根线202中的线数量和每英寸纬数可有利于编织物区段200a、200b、200c的伸长，使得当在血管BV中抽出分离系统10时，编织物区段200a、200b、200c可抵抗拉伸，同时植入物12通过摩擦保持在动脉瘤中。另外，当可压缩部分106、206、306在部署之前处于压缩构型时，编织物区段200a、200b、200c的伸长可抑制编织物区段200a、200b、200c轴向或径向塌缩。
当组装好分离装置10时，编织物区段200a、200b、200c可比近侧管100和远侧管300更具柔性。测量柔性的一种方式是执行三点弯曲测试，其中将分离系统10的一部分在两个端点处保持固定，在这些点之间的中间位置处垂直于分离系统10施加力，并且通过由该力引起的分离系统10的挠曲长度来量化柔性。当以这种方式测量时，在一些示例中，编织物区段200a、200b、200c可比远侧管300更具柔性并且比近侧管100更具柔性。换句话讲，当以相同方式对三个区段100、200a、200a、200c、300执行三点测试时，编织物区段200a、200b、200c可挠曲大于远侧管300的挠曲长度并且大于近侧管100的挠曲长度的长度。如本领域的普通技术人员将会知道和理解，可以其他方式测量柔性。
柔性编织物区段200a、200b、200c可比相对刚性的近侧管100和相对柔性的远侧管300更具柔性。延伸分离系统10的长度的大部分的相对刚性的近侧管100在被推动穿过微导管时可抵抗扭结。柔性编织物200a、200b、200c和远侧管300可各自具有足够的柔性，以在植入式医用装置12被放置在动脉瘤中时降低回推效果。因为柔性编织物区段200a、200b、200c不必像远侧管那样是可压缩弹性的，所以柔性编织物区段200a、200b、200c可具有比远侧管300更大的柔性。通过改变每英寸纬数、线段数量和/或多根线202中的线段中的每个线段的尺寸，可精确地操纵和/或控制分离系统10(包括柔性编织物区段200a、200b、200c)的可压缩性和伸长率。
如图1A和图1B所示，编织物区段200a可设置在近侧管100与远侧管300之间。锁定构件140可设置在编织物区段200a的管腔内。锁定构件140可至少在近侧方向上相对于远侧管300的远侧端部304平移。编织物区段200a的多根线202可露出。在该构型中，编织物区段200a不被聚合物套管206或任何其他保护性覆盖物覆盖。在该构型中，在将分离系统10递送到患者体内的期望位置期间，多根线202可暴露于血管的内壁。
图2A示出了具有围绕聚合物内衬204同心地设置的编织物区段200b的分离系统10。聚合物内衬204可为聚四氟乙烯(PTFE)内衬。聚合物内衬204可为编织物区段200b提供稳定性并减小编织物区段200b与设置在编织物区段200b的管腔内的锁定构件140之间的摩擦。在编织物区段200b和聚合物内衬204附接到近侧管100之前，可围绕聚合物内衬204包裹编织物区段200b，并且远侧管300或聚合物内衬204可为放置在装置的整个长度内的单独实体，装置的整个长度包括近侧管100的至少一部分、远侧管300的至少一部分以及编织物区段200b的至少一部分。
图2B示出了围绕聚合物内衬204包裹的编织物区段200b的剖视图。聚合物内衬204可具有与近侧管100和远侧管300基本上相同的形状。聚合物内衬204可为大致管状的，并且可具有穿过其设置的管腔。锁定构件140能够可滑动地设置在聚合物内衬204的管腔内。
图3A示出了分离系统10，该分离系统具有被聚合物内衬204环绕的编织物区段200c和定位在近侧管100的至少一部分、编织物区段200c以及远侧管300的至少一部分上的聚合物套管206。在组装好分离系统10之后，聚合物套管206能够可滑动地设置在近侧管100的至少一部分、编织物区段200c以及远侧管的至少一部分上。在一个示例中，聚合物套管206可定位在近侧管100的柔性区段106的至少一部分上，以在血管内导航期间抑制柔性区段的变形和/或减少与脉管系统和柔性区段106的摩擦。在一个示例中，聚合物套管206可定位在整个远侧管300上，使得聚合物套管206可附连到植入式医疗装置12附近。在一个示例中，聚合物套管206可胶合到远侧管300和/或近侧管100。另选地或除此之外，聚合物套管206可熔合在编织物区段200c上，使得聚合物套管206可结合到编织物区段200c中。可使用包括粘合剂、熔合、焊接等的附接机制将聚合物套管206附连到植入式医疗装置12。聚合物套管206可为热塑性弹性体套管。聚合物套管206可包括一种或多种添加剂以增大润滑性，使得套管可容易地滑动穿过身体血管。
聚合物套管206可为编织物区段200c提供稳定性并减小摩擦，同时将分离系统10递送到患者体内的期望位置。随着将分离系统10传送穿过脉管并到达患者体内的期望位置，聚合物套管206可保护编织物区段200c。
图3B示出了如图3A所示的分离系统10的剖视图。聚合物套管206可具有厚度介于约0.02毫米至约0.08毫米之间的壁210。在一个示例中，可将一个或多个亲水性涂层208施加到聚合物套管206。一个或多个亲水性涂层208可包含透明质酸、聚亚烷基二醇、烷氧基聚亚烷基二醇、聚(糖类)、聚(乙烯基吡咯烷酮)、聚(乙烯醇)、聚(丙烯酸)、聚(丙烯酰胺)、聚(马来酸酐)、它们的共聚物以及它们的混合物。一个或多个亲水性涂层208还可使在将分离系统10递送穿过脉管系统并到达患者体内的期望位置时可能发生的摩擦最小化。
如2A和图2B所示，编织物区段200c可包括聚合物内衬204。编织物区段200c可围绕聚合物内衬204同心地设置。聚合物内衬204可为编织物区段200c提供稳定性并减小编织物区段200c与锁定构件140之间的摩擦。
如图3B所示，锁定构件140能够平移穿过近侧递送管100和编织物区段200c的管腔。锁定构件140还可平移穿过远侧递送管300的管腔，如图3A所示。
尽管图3A和图3B示出了分离系统10，其具有围绕聚合物内衬204同心地设置的编织物区段200c以及在组装好分离系统10之后设置在近侧管100的至少一部分、编织物区段200c以及远侧管的至少一部分上的聚合物套管206，但可以设想，在一些情况下，编织物区段200c不围绕聚合物内衬204设置。
图4A至图4C示出了环线400的示例。在一些示例中，环线400可相对较小，具有毛发的粗细。由于环线400的小尺寸，环线400可被远侧递送管300的远侧端部304完全屏蔽，以防止因意外接触而损坏。环线400可为成环的伸长线，如图4A中所示。环线400a还可为具有开口405的单个伸长线，如图4B中所示。可通过松散地对半弯曲环线400a来形成开口405。在另选示例中，环线400b可包括在远侧部分处限定开口405b的扁平带，并且开口405b可处于适于接合植入式医疗装置12的端部的上翻状态。环线400、400a、400b的示例可弹性变形至上翻状态，使得其在不被另外约束时将返回到基本上平坦的状态。环线400、400a、400b可由多种材料(包括镍钛诺和不锈钢)中的任一种材料形成。
为了装载分离系统10，锁定构件140可轴向插入近侧管100、编织物区段200a、200b、200c以及远侧管300的管腔内。环线400的远侧端部404可穿过位于远侧管300的近侧端部302近侧的锚定件部分插入远侧递送管300中。环线400可穿过远侧管300的管腔到达远侧端部304。可随后使环线400的远侧端部404成环以形成开口405。开口405可穿过锁定部分18。锁定构件140可穿过开口405以接合医疗装置12。
图5A至图5D示出了植入式医疗装置12的分离，其中植入式医疗装置12是栓塞性线圈。图5A示出了分离系统10，其中植入式医疗装置12接合并且远侧管300的可压缩部分306处于压缩状态。为了达到压缩状态，可在环线400的近侧端部处牵拉环线400，并且持续的力可压缩可压缩部分306。压缩量可通过在医疗装置12安装到远侧管300的远侧端部304之后施加到环线400的近侧端部的力的大小来控制。一旦远侧管300被压缩适当的量，就可在靠近远侧管300的近侧端部302或靠近远侧管300的锚定件部分的焊丝点处锚定焊接环线400。
在图5A中，包括锁定构件140和环线400的接合系统被锁定到医疗装置12的锁定部分18内。环线400的开口405可穿过锁定部分18插入。当穿过开口405插入锁定构件140时，植入式医疗装置12可牢固地处于期望位置。
图5B示出了朝近侧拉动锁定构件140以开始植入式医疗装置12的释放序列，如箭头所示。
图5C示出了锁定构件140离开开口405并被拉出环线400的瞬间。此时，环线400的远侧端部404可返回其初始预成形形状并且可离开锁定部分18。一旦环线离开锁定部分18，就没有部件将植入式医疗装置12保持到分离系统10。
图5D示出了释放序列的结束。可压缩部分306可展开并返回到其初始伸长状态。当可压缩部分306返回到其初始伸长状态时，可压缩部分306可向前“弹出”。远侧管300的远侧端部304可向植入式医疗装置12施加弹力E，以将其“推开”，从而确保医疗装置12完全分离并递送到期望位置。
图6A至图6C示出了使用如图1A至图3B所示的相同分离装置10以及作为医疗植入物12的支架取栓器612对血管BV内的血栓T或病变进行的示例性治疗方法。支架取栓器612可具有近侧端部614和远侧端部616。支架取栓器612的近侧端部614可附连到分离装置10。锁定构件140可延伸穿过支架取栓器612的远侧端部616，如图6A所示。在被递送穿过脉管系统期间，分离装置10和支架取栓器612可设置在微导管610内。微导管610可防止支架取栓器612的撑条框架620自展开。在一些情况下，微导管610可穿过血管BV内的血栓T或病变。微导管610的尺寸可被设定成随着微导管610和支架取栓器612定位血栓T上而保持支架取栓器612塌缩在其上。支架取栓器可随着微导管610朝近侧回缩而保持在适当位置，以允许支架取栓器612展开以并置血管BV的壁。
图6B和图6C示出了可朝近侧拉动微导管610以允许支架取栓器612的撑条框架620开始展开。撑条框架620可自展开以并置血管BV的壁。支架取栓器612可包括设置在远侧端部616和近侧端部614处的环618。延伸穿过支架取栓器612的远侧端部616的锁定构件140可与环618接合，使得支架取栓器612的远侧端部616和近侧端部614保持闭合。通过经由与锁定构件140接合的环618将远侧端部616和近侧端部614保持在闭合构型，当支架取栓器612展开时，其可形成大致锥形形状或管状形状。在展开时，撑条框架620可穿过血栓T的软材料接合并展开。可随后使用附连到支架取栓器612的近侧端部614的分离装置10来有利于从血管BV移除支架取栓器612，包括所捕获的血栓T。分离装置10和带有所捕获的血栓T的支架取栓器612可朝近侧回缩，使得可有效地从血管BV移除血栓T。
在穿越包括血栓T和/或病变的受影响区域时，在一些治疗中，血栓材料可足够软以穿过支架取栓器的撑条框架620，如图6B和图6C所示。在这种情况下，随着从患者朝近侧牵拉所捕获的血栓T、支架取栓器612和分离装置10，支架取栓器612可保持附接到分离装置10。支架取栓器612和血栓T从患者身上的移除可利用穿过定位在微导管上的较大直径中间导管的辅助抽吸来执行，其中微导管的末端紧邻支架取栓器612的近侧端部614。另选地，血栓材料可能不够软而无法穿过撑条框架620，或者在移除血栓T之后可能存在血管BV的潜在变窄(狭窄)，从而继续限制病变外的流动，在这种情况下，受影响区域可通过支架植入术得到更好的治疗。
图7A和图7B示出了使用分离装置10和支架取栓器612的另外处理方法，支架取栓器可在支架植入术适当时应用。如图7A所示，当朝近侧拉动微导管610时，支架取栓器612可开始展开。随着支架取栓器612展开，支架取栓器612可压靠血栓T，从而导致血栓T压靠血管BV的壁。支架取栓器的远侧端部616和/或近侧端部614可包括环618，该环的尺寸被设定成允许锁定构件140穿过。环618可围绕支架取栓器612以一定间隔周向放置，使得当锁定构件140延伸穿过环时，远侧端部616和/或近侧端部614具有如图所示朝向锁定构件140向内延伸的锥形形状。随着朝近侧拉动锁定构件140，支架取栓器612的闭合远侧端部616可随着环618与锁定构件140脱离接合而被释放。一旦释放，远侧端部616可打开，使得远侧端部616可并置血管BV的壁。随着进一步朝近侧拉动锁定构件140，支架取栓器612的闭合近侧端部614也可被释放。近侧端部614可随后打开，使得近侧端部614可并置血管BV的壁。在该构型中，支架取栓器612被转换成永久性植入式支架，该永久性植入式支架可继续将血栓T压靠在血管BV上，以及在有或没有随后施加的血管成形术球囊扩张的帮助的情况下对血管BV的壁施加慢性力以打开任何潜在的狭窄。
如图7B所示，支架取栓器612可与分离装置10分离。一旦分离，“支架取栓器”612就不再能够从身体取回，因此其实际上是支架。支架取栓器612的分离方法可以是与图5A至图5D所示相同的分离方法。一旦部署，支架取栓器(支架)612可保持在血管BV上。
图8A至图8C示出了使用如5A至5D所示类似的分离方法和分离装置10的另外示例性支架取栓器612的部署和任选的分离。支架取栓器612可具有近侧端部614和远侧端部616。近侧端部614可附连到分离装置10，并且更具体地附连到远侧管300的远侧端部304。当支架取栓器612在部署之前附连到分离装置10时，远侧管300的可压缩部分306可处于压缩状态。
如图8A所示，接合系统140、400可与支架取栓器612接合。锁定构件140可延伸到支架取栓器612的远侧端部616，使得锁定构件140延伸穿过环线400的开口405。支架取栓器612可包括环618，该环类似于如图7A和图7B所示和所述的环。支架取栓器612可包括但不一定必须包括具有如图5A和图5B所示的几何形状的锁定部分18。如图8A所示，环线400可在支架取栓器612的近侧端部附近馈送穿过支架取栓器612，使得环线400、锁定构件140、远侧管300和支架取栓器612之间的接合被构造成将支架取栓器固定到分离装置10。支架取栓器612还可包括被构造成在递送期间保持支架取栓器612的主体的压缩的孔眼622。孔眼622的形状可类似于环618。孔眼622和环618可包括尺寸被设定成允许锁定构件140穿过其的开口。一个或多个孔眼622可附连到可展开框架620并且至少部分地围绕锁定构件140定位，从而防止可展开框架620过早部署并且支架取栓器612与接合系统140、400牢固地接合。在该构型中，即使不使用导管，也可防止可展开框架620展开。在一个示例中，一个或多个孔眼622可沿整个支架取栓器612设置。另选地，一个或多个孔眼可沿支架取栓器612的一部分设置。以举例的方式，一个或多个孔眼622可沿支架取栓器612的远侧部分设置。图8B示出了如图8A所示的示例性支架取栓器612的剖视图。支架取栓器612可附连到远侧管300，使得支架取栓器612与分离系统10接合。锁定构件140可平移穿过远侧管300并且可延伸穿过支架取栓器612。支架取栓器612的可展开框架620可包括一个或多个孔眼622。如图8B所示，孔眼622可至少部分地附连在锁定构件140周围并且附连到可展开框架620，从而防止支架取栓器612过早展开。
图8C示出了可朝近侧拉动锁定构件140以开始支架取栓器612的释放序列，如箭头所示。当朝近侧拉动锁定构件140时，远侧端部616处的环618被释放，然后孔眼622被释放。随着环618和孔眼622被释放，支架取栓器612的可展开框架620可开始展开。以举例的方式，随着朝近侧拉动锁定构件140，设置在支架取栓器612的开口远侧端部616附近的孔眼622可被首先释放，使得支架取栓器612的开口远侧端部616可开始展开。随着进一步朝近侧拉动锁定构件140，设置在支架取栓器612的近侧端部614附近的孔眼622可被释放，使得支架取栓器612的开口近侧端部614可展开。
在锁定构件140离开开口405并被拉离环线的瞬间，环线400的远侧端部404可返回到其初始预成形形状。此时，在释放序列中，没有部件将支架取栓器612保持到分离系统10，因为附连到可展开框架620的所有孔眼622都被释放。
在释放支架取栓器612之后，可压缩部分306可展开并返回到其初始伸长状态。当可压缩部分306返回到其初始伸长状态时，可压缩部分306可向前“弹出”。远侧管300的远侧端部304向支架取栓器612施加弹力，以将其“推开”，从而确保支架取栓器612完全分离并递送到期望位置。在分离时，支架取栓器612可完全展开，使得支架取栓器612可并置血管壁。
图9示出了处于可压缩状态和伸长状态的没有植入式医疗装置12的远侧管300。可压缩部分306的轴向长度可被缩短至压缩状态。当从伸长状态移动到压缩状态时，可压缩部分306可在轴向长度上缩短距离D。该压缩可沿轴线A发生。
图10是示出分离植入式医疗装置的方法1000的流程图。植入式医疗装置可包括诸如本文所示和所述的装置12、612、其变型或如本领域技术人员根据本文的教导内容理解的其另选方案。该方法可包括以非特定顺序呈现的以下步骤中的一个或多个。示例性方法1000可包括如本领域普通技术人员了解和理解的附加步骤。示例性方法可通过如本文所公开的示例性分离系统10、其变型或如本领域普通技术人员了解和理解的其另选方案来执行。
在步骤1005中，可形成远侧管300上的可压缩部分306。远侧管300上的可压缩部分306可通过螺旋切割远侧管300的一部分来形成。
在步骤1010中，可形成近侧管100上的柔性部分106。近侧管100上的柔性部分106可通过沿近侧管100的至少一部分的干涉切割来形成。
在步骤1015中，编织物区段200a、200b、200c可附接到近侧管100的远侧端部104和远侧管300的近侧端部302。
在步骤1020中，植入式医疗装置12可与接合系统140、400接合。接合系统140、400可包括锁定构件140和环线400。
该方法可包括使用带有锁定构件140的环线400来接合植入式医疗装置12，以及向环线400施加力以将可压缩部分306移动到压缩状态。
该方法可包括围绕聚合物内衬204包裹编织物区段200b，之后再将编织物区段200b附接到近侧管100的远侧端部104和远侧管300的近侧端部。
该方法可包括使聚合物套管206在近侧管100、编织物区段200c以及远侧管300的至少一部分上滑动。聚合物套管206可接合到植入式医疗装置。
该方法可包括将聚合物套管206接合到植入式医疗装置12。
该方法可包括用一个或多个亲水性涂层208涂覆聚合物套管206。
在分离期间，该方法可包括对锁定构件140施加力；使植入式医疗装置12脱离接合；以及允许可压缩部分306返回到伸长状态。通过将可压缩部分306移动到伸长状态，可部署植入式医疗装置12。
本文所包含的描述是本发明的实施方案的示例，并且不旨在以任何方式限制本发明的范围。如本文所述，本发明设想了用于血管闭塞装置的本发明的递送和释放系统的许多变型和修改，包括多种构型、多种刚度特性及其递送方法。此外，存在材料和释放机构的构型的许多可能变型。这些修改对本领域中的普通技术人员将是显而易见的，并且旨在处于以下权利要求的范围内。

Claims (20)

1.一种用于将植入式医疗装置递送到身体血管的目标位置的分离系统，包括：
大致中空的近侧管，所述近侧管具有近侧端部和远侧端部；
大致中空的远侧管，所述远侧管包括：
近侧端部；
远侧端部；和
所述远侧管自身的可压缩部分，所述可压缩部分能够从压缩状态轴向移动到伸长状态；
编织物区段，所述编织物区段设置在所述远侧管的所述近侧端部与所述近侧管的所述远侧端部之间，所述编织物区段由多根线形成；和
接合系统，所述接合系统构造成接合并部署设置在所述远侧管的所述远侧端部处的所述植入式医疗装置。
2.根据权利要求1所述的分离系统，其中所述编织物区段围绕聚合物内衬同心地设置。
3.根据权利要求1所述的分离系统，其中聚合物套管定位在所述近侧管、所述编织物区段以及所述远侧管的至少一部分上。
4.根据权利要求3所述的分离系统，其中所述聚合物套管包括一个或多个亲水性涂层。
5.根据权利要求3所述的分离系统，其中所述聚合物套管具有厚度介于约0.02毫米和约0.08毫米之间的壁。
6.根据权利要求1所述的分离系统，其中所述编织物区段包括介于约8根和约16根之间的线。
7.根据权利要求1所述的分离系统，其中所述多根线具有介于约50和约100之间的每英寸纬数。
8.根据权利要求1所述的分离系统，其中所述远侧管的所述可压缩部分为所述远侧管的螺旋切割部分。
9. 根据权利要求1所述的分离系统，其中所述接合系统构造成：
当接合所述植入式医疗装置时，将所述可压缩部分移动到所述压缩状态；以及
当将所述可压缩部分释放到所述伸长状态时，部署所述植入式医疗装置。
10.根据权利要求1所述的分离系统，其中当所述接合系统与所述植入式医疗装置脱离接合时，所述可压缩部分适于自动移动到所述伸长状态。
11. 根据权利要求1所述的分离系统，
其中所述植入式医疗装置在接合到所述接合系统时为支架取栓器，具有由所述接合系统塌缩的近侧端部和由所述接合系统塌缩的远侧端部，并且
其中所述医疗装置与所述接合系统脱离接合时为支架，具有开口近侧端部和开口远侧端部。
12.一种分离植入式医疗装置的方法，包括：
在远侧管上形成可压缩部分；
在近侧管上形成柔性部分；
将编织物区段附接到所述近侧管的远侧端部和所述远侧管的近侧端部；以及
使所述植入式医疗装置与接合系统接合。
13.根据权利要求12所述的分离方法，还包括在所述近侧管、所述编织物区段以及所述远侧管的至少一部分上滑动聚合物套管。
14.根据权利要求13所述的分离方法，还包括将所述聚合物套管接合到所述植入式医疗装置。
15.根据权利要求13所述的分离方法，还包括用一个或多个亲水性涂层涂覆所述聚合物套管。
16.根据权利要求12所述的分离方法，还包括围绕聚合物内衬包裹所述编织物区段，之后再将所述编织物区段附接到所述近侧管的所述远侧端部和所述远侧管的所述近侧端部。
17.根据权利要求12所述的分离方法，其中所述接合系统包括锁定构件和环线，
其中所述接合步骤还包括使用带有所述锁定构件的所述环线来接合所述植入式医疗装置，以及向所述环线施加力以将所述可压缩部分移动到所述压缩状态。
18.根据权利要求17所述的分离方法，还包括：
对所述锁定构件施加力；
使所述植入式医疗装置脱离接合；以及
允许所述可压缩部分返回到所述伸长状态。
19.根据权利要求12所述的分离方法，其中所述植入式医疗装置为支架取栓器，所述支架取栓器构造成在部署时展开以并置血管壁。
20.根据权利要求12所述的分离方法，还包括通过将所述可压缩部分移动到所述伸长状态来部署所接合的所述植入式医疗装置。
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US20210401601A1 (en) 2021-12-30

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