CN109998619A - 具有对开管和圆柱形联接件的可植入式医疗装置分离系统 - Google Patents

具有对开管和圆柱形联接件的可植入式医疗装置分离系统 Download PDF

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CN109998619A
CN109998619A CN201811571900.6A CN201811571900A CN109998619A CN 109998619 A CN109998619 A CN 109998619A CN 201811571900 A CN201811571900 A CN 201811571900A CN 109998619 A CN109998619 A CN 109998619A
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distal tube
medical device
implantable medical
distal
connector
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J.勒伦佐
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DePuy Synthes Products Inc
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Abstract

本发明公开了一种用于将可植入式医疗装置递送到身体血管的目标位置的分离系统，所述分离系统具有大致中空的远侧管，所述远侧管包括近侧端部、远侧端部和所述管本身的可压缩部分，所述可压缩部分在所述近侧端部和所述远侧端部之间，能够从压缩状况轴向移动到伸长状况；大致中空的近侧管，所述近侧管具有近侧端部和远侧端部；联接件，所述联接件将所述近侧管和所述远侧管结合；接合系统，所述接合系统接合并部署在所述远侧管的所述远侧端部处接合的所述可植入式医疗装置，当接合所述可植入式医疗装置时，所述接合系统将所述可压缩部分移动到所述压缩状况，并且部署所述可植入式医疗装置并将所述可压缩部分释放到所述伸长状况。

Description

具有对开管和圆柱形联接件的可植入式医疗装置分离系统
技术领域
本发明整体涉及可通过人类受试者的身体血管进行导航的介入医疗装置系统。更具体地讲，本发明涉及用于将可植入式医疗装置部署到身体血管的目标位置的分离系统及其使用方法。
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，扩张球囊、支架和栓塞线圈)已经成为治疗血管内疾病的标准过程。已经发现，此类装置在无法进行传统操作过程或传统操作过程对患者构成很大风险的治疗领域中(例如，在颅内血管中动脉瘤的治疗中)尤其有用。由于围绕颅内血管的组织非常脆弱(尤其是例如脑组织)，执行外科手术来治疗颅内血管的缺陷是非常困难的并且通常是有风险的。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。导管递送系统优点中的一些是，通过已经发现的降低对周围组织造成创伤风险的方法来提供用于治疗血管的方法，并且还允许治疗过去视为无法手术的血管。
通常，这些手术涉及将递送导管的远侧端部插入到患者的脉管系统中，并且引导其穿过脉管系统到达预定的递送部位。血管闭塞装置(诸如，栓塞线圈)附接到递送构件的端部，递送构件推动线圈穿过导管并离开导管的远侧端部进入到递送部位中。与这些过程相关联的问题中的一些涉及确保线圈的完全释放和部署。例如，授予Palermo的美国专利5,250,071描述了其中系统和线圈的互锁扣件通过控制线保持在一起的分离系统，该专利据此以引用方式并入本文。控制线朝近侧移动以使扣件彼此脱离。然而，系统不包括用于将脱离的扣件彼此分开的任何可靠装置，因此仅回缩控制线不确保线圈的释放和部署。目前使用的许多其他分离系统也存在类似的问题。
此外，美国专利8,062,325公开了递送和部署血管闭塞装置的单个管状载体，但其仅具有单个可压缩区段。因此，仍然需要可确保可植入式医疗装置的释放和部署的更快速的释放分离系统或方法。利用结合简单且廉价的锁定和部署系统的分离系统或方法还可实现另外的优点。
发明内容
分离系统利用大致中空的远侧管将可植入式医疗装置递送到身体血管的目标位置。远侧管具有近侧端部、远侧端部和远侧管本身的可压缩部分，可压缩部分可在近侧端部和远侧端部之间从压缩状况轴向移动到伸长状况。分离系统还包括大致中空的近侧管、联接件和接合系统，近侧管具有近侧端部和远侧端部，联接件设置在远侧管的近侧端部和近侧管的远侧端部之间，从而将近侧管和远侧管结合，接合系统接合并部署在远侧管的远侧端部处接合的可植入式医疗装置。当接合可植入式医疗装置时，接合系统将可压缩部分移动到压缩状况，并且部署可植入式医疗装置并将可压缩部分释放到伸长状况。
在另一个示例中，当接合可植入式医疗装置时，接合系统可以可移除地固定到远侧管的近侧端部，以保持压缩状况。另外，当接合可植入式医疗装置时，接合系统可以可移除地固定到近侧管的近侧端部。
接合系统的示例具有锁定构件和环线。当环线与锁定构件相互作用以接合可植入式医疗装置时，环线上的力将可压缩部分移动到压缩状况，并且环线焊接到远侧管的近侧端部以可移除地固定接合系统。锁定构件上的力释放环线，使可植入式医疗装置脱离，并且允许可压缩部分返回伸长状况。
其他示例具有远侧管的可压缩部分作为远侧管的螺旋切割部分。当可压缩部分移动到伸长状况时，可压缩部分可适于部署由接合系统接合的可植入式医疗装置。此外，当接合系统与可植入式医疗装置脱离时，远侧管的可压缩部分适于自动地/弹性地移动到伸长状况。近侧管还可包括近侧管本身的柔性部分，所述柔性部分在近侧端部和远侧端部之间，是柔性的，并且远侧管可包括远侧管本身的柔性部分，所述柔性部分在近侧端部和可压缩部分之间，是柔性的。
另外的示例具有部分地搭接联接件的近侧管、部分地搭接联接件的远侧管，并且在近侧管和远侧管之间在联接件上形成的间隙包括焊接带以将联接件焊接到近侧管和远侧管。在一个示例中，联接件是不透射线的。
使用上述示例分离可植入式医疗装置的方法可包括以下步骤：在近侧端部和远侧端部之间在远侧管上形成可压缩部分；将可植入式医疗装置与接合系统接合；向接合系统施加力，以压缩可压缩部分；将接合系统固定到远侧管以保持压缩状态；并且使用联接件将远侧管和近侧管结合在一起。如上所述，接合系统可以可移除地固定到远侧管的近侧端部。
分离方法示例还可具有以下步骤：当接合可植入式医疗装置时，将接合系统可移除地固定到近侧管的近侧端部。接合步骤可包括使用环线与锁定构件来接合可植入式医疗装置的步骤；并且施加步骤还包括将力施加到环线以将可压缩部分移动到压缩状况的步骤。其他示例性步骤包括：将力施加在锁定构件上；使可植入式医疗装置脱离；以及允许可压缩部分返回伸长状况。
成形步骤的示例可包括螺旋切割远侧管的一部分的步骤，并且还具有通过将可压缩部分移动到伸长状况来部署所接合的可植入式医疗装置的步骤。另外，当接合系统与可植入式医疗装置脱离时，远侧管的可压缩部分可适于自动地/弹性地移动到伸长状况。
此外，结合步骤还具有以下步骤：将近侧管在联接件上部分地搭接；将远侧管在联接件上部分地搭接；在近侧管和远侧管之间在联接件上形成包括焊接带的间隙，以及在焊接带处将联接件焊接到近侧管和远侧管。
附图说明
参见以下具体实施方式并结合附图进一步讨论本发明的上述方面和另外的方面，在附图中，相同的编号指示各种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。
图1A是本发明的分离系统的示例的分解视图，其中医疗装置被部分地脱离；
图1B是图1A的放大图；
图2是本发明的分离系统的示例的分解视图，其中医疗装置被接合；
图3A是根据一个示例的环线的示例的侧透视图；
图3B是根据另一个示例的环线的示例的平面图；
图4是另选示例中处于上翻状况下的环线的开口的前透视细部图；
图5A是本发明的分离系统的示例的分解视图，其中医疗装置被接合并且环线被固定；
图5B是固定到远侧管的环线的放大图；
图6是搭接联接件的近侧管和远侧管的平面图；
图7是焊接到联接件的近侧管和远侧管的平面图；
图8示出了在小管处的近侧焊接；
图9示出了分离系统的示例的荧光镜视图；
图10示出了形成本发明的分离系统的示例性方法；
图11A至图11D示出了具有部分横截面的正在被分离的医疗装置；
图12是处于压缩和膨胀状态下的远侧管的示例的侧视图；并且
图13是正在被分离的医疗装置的示例的前侧透视图。
具体实施方式
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”应当被广义地理解为但不限于正圆柱体或横截面呈严格圆周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柱状体的结构。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。
本发明的分离系统10的示例(如图1A、图1B和图2所示)可具有近侧细长递送海波管组件100、中间联接件200和远侧递送管300。可植入式医疗装置12接合在远侧递送管300的一个端部处。可植入式医疗装置12可为栓塞线圈，但应当理解，可通过根据本发明的分离系统10递送和部署几乎任何可植入式医疗装置12。使用锁定构件140和环线400将医疗装置12接合到系统。医疗装置12具有锁定部分18以与接合系统140、400连接。
近侧递送管100可具有近端部分102、远端部分104和在这两者之间的柔性部分106。近侧递送管100在其中形成轴向管腔108。近侧端部102沿轴向管腔108与直径较小的管110接合(参见图5A、图6至图8)。远侧递送管300可具有近端部分302、远端部分304和在这两者之间的可压缩部分306。在一个示例中，可压缩部分306可更靠近远端部分304，并且柔性部分305可在近端部分302和可压缩部分306之间。远侧递送管300在其中形成轴向管腔308。
递送管100、300可由生物相容性材料诸如不锈钢制成。管100、300的直径通常可为介于约0.010英寸至约0.018英寸之间，优选管的直径为大约0.0145英寸。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)。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。
柔性部分106、305允许递送管100、300弯曲并挠曲。这有助于通过穿过人类脉管系统的导管和曲折路径来跟踪系统10。柔性部分106、306可形成有干涉螺旋切口。这些切口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。因此，可弯曲并挠曲，但不压缩。
可压缩部分306可在伸长状况和压缩状况之间轴向调节。优选地，可压缩部分306由通过激光切割操作形成的管300的螺旋切割部分形成。然而，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。最优选地，除非另有限制，否则可压缩部分306在静止时处于伸长状况并且从压缩状况自动地或弹性地返回到伸长状况。本文更详细地描述了可压缩部分306的功能。
联接件200的示例具有近侧区段202、远侧区段204、在这两者之间的焊接带206以及在其中的轴向管腔208。联接件200桥接递送管100、300两者，并且可提供不透射线的标记以有助于在临床使用中将分离系统10在递送导管中对齐。中间联接件200的示例可为标记带或线圈段。
图3A、图3B和图4示出了环线400的示例。环线400可相对较小，在一些实施方案中它具有头发的厚度，因此它可优选地被远侧递送管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可为成环的细长线，如图3A中所示。环线400a还可为具有开口405的单个细长线，如图3B中所示。可通过松散地对半弯曲环线400a来形成开口405。在另选的示例中，环线400b包括限定在远侧部分处的开口405a的扁平带，并且开口405a可处于适合接合可植入式医疗装置12的端部的上翻状况。环线400、400a、400b的示例可弹性变形到上翻状况，由此使得在未以其他方式限制的情况下其将返回到基本上扁平的状况下。环线400、400a、400b可由多种材料(包括镍钛诺和不锈钢)中的任一种形成。
为了加载分离系统10，锁定构件140轴向插入到两个管100、300和联接件200的管腔108、208、308内。环线400的远侧端部404通过定位在远侧管300的近侧端部302上的锚定部分310插入到远侧递送管300中，并且穿过管腔308到达远侧端部304。然后，环线404的远侧端部可成环，以形成开口405。开口405穿过锁定部分18，并且锁定构件140穿过开口405以接合医疗装置12。参见图1A和图11A。
在环线402的近侧端部处拉紧环线400，并且持续的力F压缩可压缩部分306。在医疗装置12安装在远侧管300的远侧端部304上之后，可通过施加到环线400的近侧端部402的力F的量来控制压缩量。图2和图11A示出了安装的医疗装置12和处于压缩状态的远侧管300。一旦远侧管300被压缩适当的量，环线400在线焊点406处(在近侧端部402和远侧端部404之间)就锚定焊接408到在远侧递送管300的锚定部分310处或附近的近侧端部302(即，在可压缩部分306后面)。参见图5A和图5B。在用锚固焊接部408将环线400固定就位之前，通过改变在环线400上的力F的大小来调整远侧递送管300的压缩水平。
图6和图7示出了使用联接件200对近侧递送管100和远侧递送管300进行的结合。图6示出了正朝向联接件200的近侧端部202被拉动并与之搭接的近侧管100的远侧端部104。类似地，远侧管300的近侧端部302正朝向联接件200的远侧端部204被拉动并与之搭接。在该示例中，近侧管100和远侧管300不接触联接件200，而是将焊接带206保留为在联接件200上的间隙。两个管100、300然后在焊接带206处周向焊接210在一起，以形成一体装置10。中间联接件200桥接递送管100、300两者，并且提供不透射线的标记以在临床使用中将系统10与递送导管(未示出)对齐。
在两个管100、300与联接件200搭接和焊接之前，拉动锁定构件140(如上文所述)穿过联接件管腔208，并且穿过近侧管管腔108到达小管110。在小管110中与近侧管100的近侧端部102相对的近侧开口112处，锁定构件140焊接142到小管110。这在图8中示出。
图9示出了荧光镜视图中的分离系统10。鉴于联接件200和医疗装置12通常由不透射线标记制成或者具有不透射线标记，它允许近侧管100a和远侧管300a的视图具有与联接件200a或医疗装置12a的不同对照。这提供了指示何时释放了设备12a的视觉反馈(将在下文中进一步讨论)。
图10示出了组装分离系统10的方法的示例。该方法包括在远侧管300上形成可压缩部分306(步骤1000)以及在近侧管100上形成柔性部分106(步骤1002)。步骤1002还可包括在远侧管300上形成柔性部分305。可压缩部分306可通过螺旋切割远侧管300或者通过形成可压缩且然后可快速返回到其未压缩状态的管的任何其他方式来形成。近侧管100的柔性部分106可被干涉切割或者通过任何其他方式来增大近侧管100的柔性。一旦至少远侧管300准备好，医疗装置12就可与接合系统140、400接合(步骤1004)，并且可将力F施加到接合系统140、400以压缩可压缩部分306(步骤1006)。这里应当注意，尽管上文示出将锁定构件140和环线400用作接合系统的示例，但普通技术人员可利用不同的方法来固定医疗装置12，同时仍在可压缩部分306上施加可释放的力，以在接合系统140、400与医疗装置12脱离时释放该力。接合系统140、400的区段406然后接合到远侧管300，以保持可压缩部分306的压缩状态(步骤1008)。接合系统140、400的一部分穿过联接件200和近侧管100(步骤1010)。使用联接件200将远侧管300和近侧管100结合在一起(步骤1012)。此处，在该示例中，管100、300的端部104、302与联接件200搭接，并且所有三者焊接在一起210。接合系统140、400的端部144然后可结合到近侧管100的近侧端部102(步骤1014)以完成装置10。
转到图11A至图11D，其更详细地示出了医疗装置12的分离。图11A示出了锁定到医疗装置12的锁定部分18中的接合系统140、400。可穿过锁定部分18放置环线400的开口405。当锁定构件140穿过开口405时，医疗装置12现在是固定的。预先施加力F以将远侧管300置于压缩状态下。图11B示出了朝近侧拉动锁定构件140以开始医疗装置12的释放序列。图11C示出了锁定构件140退出开口405并被拉离环线400的瞬间。环线400的远侧端部404脱离/返回其预成形形状(如上文所讨论)并退出锁定部分18。可以看出，现在没有任何东西将医疗装置12保持到分离系统10。图11D示出了释放序列的结束。此处，可压缩部分306已经膨胀/返回到其原始形状并且向前“弹出”。弹力E由远侧管300的远侧端部304施加到医疗装置12以“推动”其离开，以确保医疗装置12的彻底分离和递送。
图12示出了远侧管300，其被示出为不具有医疗装置12，但其中可压缩部分306在轴向长度上缩短到压缩状况。特别地，示出了距离“D”，在将可压缩部分306从伸长状况移动到压缩状况时，远侧管300轴向缩短距离“D”。这种压缩可沿轴线A发生。图13示出了分离时的医疗装置12的另一个视图。已朝近侧拉动锁定构件140，使得其与环线400分离，从而允许医疗装置12随着远侧压缩部分306膨胀而分离，并且还将医疗装置12与递送系统10分离。箭头“E”表示弹力“推动”医疗装置12远离远侧端部304，以确保其彻底分离并递送到患者体内的目标部位。弹力E作用在管腔308的轴线A上，并且沿相同的轴线A“推动”医疗装置12(参见图8和图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。这些修改将对本发明所属领域中的普通技术人员显而易见，并且旨在处于以下权利要求的范围内。

Claims (20)

1.一种用于将可植入式医疗装置递送到身体血管的目标位置的分离系统，所述分离系统包括：
大致中空的远侧管，所述远侧管包括：
近侧端部；
远侧端部；和
所述远侧管本身的可压缩部分，所述可压缩部分在所述近侧端部和所述远侧端部之间，能够从压缩状况轴向移动到伸长状况；
大致中空的近侧管，所述近侧管具有近侧端部和远侧端部；
联接件，所述联接件设置在所述远侧管的所述近侧端部和所述近侧管的所述远侧端部之间，从而将所述近侧管和所述远侧管结合；
接合系统，所述接合系统接合并部署在所述远侧管的所述远侧端部处接合的所述可植入式医疗装置；
其中当接合所述可植入式医疗装置时，所述接合系统将所述可压缩部分移动到所述压缩状况，并且
其中所述接合系统部署所述可植入式医疗装置，并且将所述可压缩部分释放到所述伸长状况。
2.根据权利要求1所述的分离系统，其中当接合所述可植入式医疗装置时，所述接合系统可移除地固定到所述远侧管的所述近侧端部，以保持所述压缩状况。
3.根据权利要求2所述的分离系统，其中当接合所述可植入式医疗装置时，所述接合系统可移除地固定到所述近侧管的所述近侧端部。
4.根据权利要求2所述的分离系统，其中所述接合系统包括：
锁定构件；和
环线，
其中当所述环线与所述锁定构件相互作用以接合所述可植入式医疗装置时，所述环线上的力将所述可压缩部分移动到所述压缩状况，并且
其中所述环线焊接到所述远侧管的所述近侧端部，以可移除地固定所述接合系统。
5.根据权利要求4所述的分离系统，其中所述锁定构件上的力释放所述环线，使所述可植入式医疗装置脱离，并且允许所述可压缩部分返回所述伸长状况。
6.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。
7.根据权利要求1所述的分离系统，其中当所述可压缩部分移动到所述伸长状况时，所述可压缩部分适于部署由所述接合系统接合的所述可植入式医疗装置。
8.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可植入式医疗装置脱离时，所述远侧管的所述可压缩部分适于自动地/弹性地移动到所述伸长状况。
9.根据权利要求1所述的分离系统，
其中所述近侧管与所述联接件部分地搭接，
其中所述远侧管与所述联接件部分地搭接，
其中在所述近侧管和所述远侧管之间在所述联接件上形成的间隙包括焊接带，以将所述联接件焊接到所述近侧管和所述远侧管。
10.根据权利要求1所述的分离系统，其中所述联接件是不透射线的。
11.根据权利要求1所述的分离系统，
其中所述近侧管包括所述近侧管本身的柔性部分，所述柔性部分在所述近侧端部和所述远侧端部之间，是柔性的；并且
其中所述远侧管包括所述远侧管本身的柔性部分，所述柔性部分在所述近侧端部和所述可压缩部分之间，是柔性的。
12.一种分离可植入式医疗装置的方法，所述可植入式医疗装置包括中空远侧管、中空近侧管和联接件，所述中空远侧管具有近侧端部和远侧端部，所述中空近侧管具有近侧端部和远侧端部，所述方法包括以下步骤：
在所述近侧端部和所述远侧端部之间在所述远侧管上形成可压缩部分；
将所述可植入式医疗装置与接合系统接合；
向所述接合系统施加力，以压缩所述可压缩部分；
将所述接合系统固定到所述远侧管，以保持压缩状态；
使用所述联接件将所述远侧管和所述近侧管结合在一起。
13.根据权利要求12所述的分离方法，其中所述接合系统可移除地固定到所述远侧管的所述近侧端部。
14.根据权利要求13所述的分离方法，所述分离方法还包括当接合所述可植入式医疗装置时将所述接合系统可移除地固定到所述近侧管的所述近侧端部的步骤。
15.根据权利要求13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所述环线与所述锁定构件来接合所述可植入式医疗装置的步骤；并且
其中所述施加步骤还包括将力施加到所述环线以将所述可压缩部分移动到所述压缩状况的步骤。
16.根据权利要求15所述的分离方法，所述分离方法还包括以下步骤：
将力施加在所述锁定构件上；
使所述可植入式医疗装置脱离；以及
允许所述可压缩部分返回所述伸长状况。
17.根据权利要求12所述的分离方法，其中所述成形步骤包括螺旋切割所述远侧管的一部分的步骤。
18.根据权利要求12所述的分离方法，所述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况来部署所接合的所述可植入式医疗装置的步骤。
19.根据权利要求12所述的分离方法，其中当所述接合系统与所述可植入式医疗装置脱离时，所述远侧管的所述可压缩部分适于自动地/弹性地移动到所述伸长状况。
20.根据权利要求12所述的分离方法，其中所述结合步骤还包括以下步骤：
将所述近侧管在所述联接件上部分地搭接；
将所述远侧管在所述联接件上部分地搭接；
在所述近侧管和所述远侧管之间在所述联接件上形成包括焊接带的间隙；以及
在所述焊接带处将所述联接件焊接到所述近侧管和所述远侧管。
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