CN112168263A - 具有柔性抗拉伸远侧部分的医疗装置递送构件 - Google Patents

具有柔性抗拉伸远侧部分的医疗装置递送构件 Download PDF

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CN112168263A
CN112168263A CN202010630877.4A CN202010630877A CN112168263A CN 112168263 A CN112168263 A CN 112168263A CN 202010630877 A CN202010630877 A CN 202010630877A CN 112168263 A CN112168263 A CN 112168263A
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hypotube
medical device
coil
wire
distal
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J·洛伦佐
T·蒙特里多罗
D·索伦
D·布卢门斯蒂克
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DePuy Synthes Products Inc
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Abstract

本发明题为“具有柔性抗拉伸远侧部分的医疗装置递送构件”。本发明提供了一种用于递送和部署血管内医疗装置的递送构件。该递送构件包括柔性远侧部分，该柔性远侧部分包括卷绕线材线圈，该卷绕线材线圈由柔性套管围绕并且通过定位成穿过该线圈的管腔的抗拉伸构件而被抑制在长度方向上延伸。该递送构件可包括定位在该卷绕线材线圈的任一侧(远侧和朝近)上的海波管，该抗拉伸构件和该卷绕线材线圈可附接到该海波管。

Description

具有柔性抗拉伸远侧部分的医疗装置递送构件
技术领域
本发明总体上涉及可导航通过人类受检者的身体血管的血管内医疗装置系统。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递送系统和递送构件以及使用它们的方法。
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域，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(例如，脑组织)较脆弱，进行外科手术治疗颅内血管的缺陷可能很困难，而且常常有风险。基于导管的植入物递送系统的进步在这种情况下提供了替代治疗。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，这些规程涉及将递送导管插入患者的脉管系统中并引导递送导管通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/部署系统(在此等同地称为“接合系统”或“部署系统”)，该递送构件推动线圈通过递送导管并从递送导管的远侧端部出来进入递送部位。美国专利申请15/850,993和美国专利申请15/964,857中描述了示例性递送构件和接合/部署系统，上述专利申请的每一个以引用方式并入本文。
与正确执行这种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规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线圈的过早脱离。
因此，需要改进的方法、装置和系统来提供具有增加的稳定性的植入物递送构件和植入物接合系统。
发明内容
本发明的目的是提供满足上述需求的系统、装置和方法。一般来讲，本发明的目的是提供一种递送构件，该递送构件用于递送和部署具有柔性远侧部分的植入式医疗装置。
当递送构件的远侧端部推进通过曲折的远侧解剖结构时，递送构件的远侧部分的刚度可导致用于递送栓塞材料的微导管从动脉瘤中拉回。如果微导管在推进栓塞材料的同时拉回，则微导管可能脱离动脉瘤，并且医师可能失去对栓塞线圈的控制，并且不能准确控制栓塞材料的放置，并且可能不能完成治疗。
通过沿递送构件的远侧部分结合一定长度的卷绕线圈可以提供柔性。卷绕线圈可通过位于线圈外部的柔性聚合物套管保护。通过附连到卷绕线圈的任一端上的海波管的抗拉伸管，可以抑制卷绕线圈伸长。
用于将植入式医疗装置递送到身体血管的目标位置的示例性递送构件可包括远侧海波管、支撑线圈区段、近侧海波管、覆盖支撑线圈区段的柔性套管以及延伸横跨支撑线圈区段的抗拉伸构件。远侧海波管、支撑线圈区段和近侧海波管可形成具有穿过其的管腔的连续管状结构。柔性套管可以覆盖支撑线圈区段的一些或全部，以防止支撑线圈区段的径向扩张并提高支撑线圈区段滑动通过脉管系统的能力。抗拉伸构件可以附连到近侧海波管和远侧海波管，由此延伸横跨整个支撑线圈区段。
递送构件还可包括接合系统，该接合系统可移动以接合和部署植入式医疗装置。接合系统可包括环线和牵拉线。环线可延伸穿过植入式医疗装置中的开口，并且牵拉线可接合至环线，由此将接合系统接合至植入式医疗装置。牵拉线可以定位在递送构件的管腔内并且可以朝近侧回缩以脱离接合环线。一旦从牵拉线脱离接合，环线即能够移动以从植入式医疗装置中的开口回缩，由此部署植入式医疗装置。
当移动接合系统以部署植入式医疗装置时，远侧海波管的至少一部分可以在接合系统移动时被压缩并且可以伸长。
支撑线圈区段可包括非不透射线的近侧线圈、非不透射线的远侧线圈以及位于非不透射线的线圈之间的不透射线的中央线圈。
支撑线圈区段可以由卷绕以限定递送构件的管腔的一部分的线材制成。制成支撑线圈的线材可具有约0.8密耳至约5密耳(约20nm至约130nm)的横截面直径。
柔性套管可以包括聚合物。柔性套管可以包括添加剂以增加聚合物的润滑性。
柔性套管可以附连到近侧海波管和远侧海波管。因此构造的柔性套管可以覆盖整个盘绕区段以及近侧海波管的至少一部分和/或远侧海波管的至少一部分。
抗拉伸构件可以是挤压管。
支撑线圈区段和远侧海波管可具有从支撑线圈的近侧端部到远侧海波管的远侧端部测量的长度，该长度为约30cm至约50cm，或更具体地为约40cm。
近侧海波管在其远侧端部附近可包括螺旋切割部分。
用于设计或构造递送构件(诸如上述示例)的示例性方法可包括以下步骤：选择第一海波管和第二海波管；在所述两个海波管之间形成线材线圈区段；将抗拉伸构件延伸穿过线材线圈区段的管腔；将抗拉伸构件附连到第一海波管和第二海波管；选择柔性套管；用柔性套管覆盖支撑线圈区段；以及将植入式医疗装置附接到第一海波管的远侧端部，使得植入式医疗装置可以在治疗期间从第一海波管分离。
形成线材线圈区段的步骤可以包括：形成非不透射线的近侧线圈；形成非不透射线的远侧线圈；以及形成在非不透射线的近侧线圈和非不透射线的远侧线圈之间延伸的不透射线的中央线圈。另选地，支撑线圈区段不需要包括不透射线的区段。形成线材线圈区段的步骤可以附加地或另选地包括选择直径为约0.8密耳至约5密耳(约20nm至约130mm)的线材，并且卷绕该线材以形成线材线圈区段并限定线材线圈区段的管腔。
选择柔性套管的步骤可以包括选择具有添加剂的聚合物套管，以增加聚合物的润滑性。
将抗拉伸构件延伸穿过线材线圈管腔的步骤可以包括延伸基本上管状的抗拉伸构件穿过线材线圈管腔。
将植入式医疗装置附接到第一海波管的步骤可包括压缩第一海波管并将植入式医疗装置附接到经压缩的第一海波管的远侧端部。
用于设计或构造递送构件的示例性方法还可包括将环线定位在第一海波管的管腔内，并且定位牵拉线以延伸穿过第一海波管、线材线圈区段和第二海波管的管腔。附接植入式医疗装置的步骤可附加地或另选代地包括将环线延伸穿过植入式医疗装置中的开口，并且将牵拉线接合到延伸穿过植入式医疗装置的开口的环线的一部分。附接植入式医疗装置的步骤可以附加地或另选代地包括将牵拉线定位成从第二海波管的近侧端部朝近侧延伸。
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。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1是根据本发明的方面的递送构件的横截面的图示；
图2A是根据本发明的方面的柔性套管的横截面的图示；
图2B是根据本发明的方面的抗拉伸管的横截面的图示；
图2C是根据本发明的方面的附连到远侧海波管和近侧海波管的线材线圈的横截面的图示；
图3A至图3D是接合系统的图示，该接合系统示出了根据本发明的方面的用于部署植入物的顺序；
图4是示出根据本发明的方面的用于设计或构造递送构件的方法的流程图；并且
图5是示出根据本发明的方面的使用包括示例性递送构件的递送系统的方法的流程图。
具体实施方式
在血管内治疗(例如，动脉瘤闭塞治疗)期间，在植入物或其他医学治疗装置被放置在动脉瘤或其他治疗部位中时，治疗装置递送构件的远侧部分缺乏柔性可导致递送构件从治疗部位拉回或以其他方式移出位置。因此，除了面临类似挑战的其他应用之外，具有更柔性的远侧部分的递送构件和接合系统可以提供用于在神经血管解剖结构中递送医疗装置的稳定系统。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。递送构件的变形可抑制递送构件导航至治疗部位和/或有效部署医疗装置的能力。递送构件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递送构件，其具有高度柔性的远侧部分，该远侧部分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。为了便于讨论，医学治疗装置在本文中通常被称为“植入物”，但是如本领域普通技术人员将理解和明白的，本发明的方面可以被应用于递送和部署未植入的医疗装置。
根据本发明，在一些示例中，递送构件的高度柔性的远侧部分可包括盘绕线材、外部套管和内部抗拉伸构件。盘绕线材可以由卷绕成线圈形状的基本线性的线材和/或以螺旋图案激光切割的海波管形成。如果盘绕线材是由激光切割海波管形成的，则螺旋可以没有连接线圈中的绕组的干涉切口，以便提供更柔性的线圈。外部套管可以抑制盘绕线材径向变形和/或提供平滑表面，在植入物的递送期间血管壁可以抵靠该平滑表面滑动。抗拉伸构件可以在植入物的递送期间抑制盘绕线材的伸长。因此，盘绕线材、外部套管和抗拉伸构件的组合可以提供递送构件的远侧部分，该远侧部分具有比至少一些已知递送构件更大的柔性和更大的稳定性。
转到附图，如图1所示，示例性递送构件10可以包括近侧管100、盘绕区段200、远侧管300、围绕盘绕区段的套管500以及盘绕区段200的管腔内的抗拉伸构件600。近侧管100可以延伸递送构件10的大部分长度，其中盘绕区段200和远侧管300形成足以吸收在治疗部位处放置植入物期间可能发生的大部分回推的长度。在一些示例中，该长度可以介于约30cm与约50cm之间，或者更具体地，为约40cm。近侧管100可具有连接到盘绕区段200的近侧端部202的远侧端部104，并且盘绕区段200可具有连接到远侧线圈300的近侧端部302的远侧端部204。
图2A是套管500的剖视图。图2B是抗拉伸构件600的剖视图。图2C是组装的近侧管100、盘绕区段200和远侧管300的剖视图。
盘绕区段200可以与近侧海波管100和/或远侧海波管300分开形成。分开形成的盘绕区段200可以通过焊接712、714或其他适当的附件附连到近侧管100和/或远侧管300。另选地或除此之外，可以由海波管的螺旋激光切割部分形成盘绕区段的至少一部分。通过选择具有特定直径D的特定横截面(例如，圆形)的线材，或者通过选择具有增加柔性的材料特性的线材，可以使分开形成的盘绕区段200与螺旋切割管相比更加柔性。相反，通过切割单个海波管以形成近侧管100、盘绕区段200和远侧海波管300，减少或消除焊接712、714或其他附件，可以更容易地制造激光切割部分。在任一情况下，线圈200的线材可以具有在包括约0.8密耳和5密耳(约20nm至约130nm)的范围内的直径D。
盘绕区段可以主要由非不透射线的材料(诸如钢)形成，并且可以包括由不透射线的材料(诸如铂和/或钨)制成的不透射线的区段216。不透射线的区段216可被定位在线圈212的近侧、非不透射线的区段和线圈214的远侧、非不透射线的区段之间。可以将不透射线的区段216定位成距递送构件10的远侧端部304预先确定的距离处，使得医师在治疗规程期间可以容易地可视化递送构件的远侧部分的放置。近侧区段212、不透射线的区段216和远侧区段214可以同心焊接。
盘绕区段200可以被柔性套管或熔合护套500(在本文中统称为“套管”)围绕。套管可以抑制线圈200在导航期间径向扩张和/或与血管壁接合。套管500可包括聚合物。聚合物可以包括添加剂以增加套管500的润滑性，从而使得套管可以容易地滑过身体血管。如图2A所示，套管500可具有在包括约0.5密耳和约2密耳(约0.01mm至约0.05mm)的范围内测量的壁厚T。套管500可以进一步涂覆有亲水涂层，以进一步最小化血管内导航期间的摩擦。套管500可以熔合或胶合到线圈200、近侧海波管100和/或远侧海波管300。
可以定位抗拉伸构件600以在血管内导航期间抑制线圈200的伸长。抗拉伸构件600可包括尺寸被设置成配合在线圈200的管腔208内的管。抗拉伸管600的尺寸也可以被设置成延伸穿过线圈200的整个长度，在近侧管100的管腔108内和远侧线圈300的管腔308内延伸。抗拉伸构件600可以在粘合接头702、704处或其他适当的附件处附接到近侧管100和远侧管300。抗拉伸构件600可以保持未附接到盘绕区段200，使得抗拉伸构件600和盘绕区段200能够在某种程度上彼此独立地移动。
递送构件10可包括用于在递送期间接合医学治疗装置的机械接合系统，该机械接合系统可被机械致动以部署治疗装置。机械致动的接合系统通常包括延伸穿过递送构件的一个或多个内部细长构件或牵拉线，医师可以在近侧端部处操纵所述一个或多个内部细长构件或牵拉线来部署医学治疗装置。此类线或内部细长构件在本文中一般称为“牵拉线”。
图3A至图3D示出了包括机械接合系统的递送构件10，该机械接合系统包括牵拉线140和环线400，所述牵拉线和环线可被定位成将植入物或其他医学治疗装置固定到递送构件10，并且可被移动以从递送构件10释放医学治疗装置。可以通过焊接408或其他合适的附件将环线400附连到远侧管300上(参见图1)。抗拉伸构件600的尺寸可被设置成允许牵拉线140穿过近侧管100、盘绕区段200和远侧管300的管腔108、208、308。例如，抗拉伸构件600可以是管状的，具有穿过其的管腔，并且牵拉线140可以延伸穿过管状抗拉伸构件600的管腔。在抗拉伸构件600的制造期间，抗拉伸构件600可被挤出在牵拉线140上方。
线圈200、套管500和抗拉伸构件600的组合可以提供递送构件10的高度柔性的远侧部分，该远侧部分适合于导航曲折的解剖结构(包括神经血管)。抗拉伸构件600可以支撑线圈200，以防止线圈200在血管的导航期间显著地延伸，由此减小穿过其延伸的牵拉线140上的张力，并且减小附接的医学治疗装置过早部署的可能性。
近侧管100可以包括柔性区段106，该柔性区段去除了材料以增加柔性区段106的柔性。柔性区段106可以被切割成螺旋图案。柔性区段106的螺旋图案可以没有连接螺旋内绕组的干涉切口。抗拉伸构件600可延伸穿过柔性区段106，并且从柔性区段106沿近侧方向附接到近侧管100。抗拉伸构件600由此可以抑制近侧管100的柔性区段106和盘绕区段200的伸长。套管500可以覆盖柔性区段106的至少一部分，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。在一些示例中，套管500可覆盖近侧管100的约10cm，接近和/或包括近侧管100的远侧端部104。
远侧管300可包括可压缩部分306。可压缩部分306可在伸长状态和压缩状态之间轴向调节。可压缩部分306可以由管300的通过激光切割操作形成的螺旋切割部分形成。附加地或另选地，可压缩部分可以由卷绕线材、螺旋带或根据本发明的允许轴向调节的其他布置形成。优选地，除非另有限制，可压缩部分306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。
图3A至图3D示出了使用机械接合/部署系统脱离医疗装置12。图3A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。可以压缩远侧管300的可压缩部分306，并且在环线400的远侧端部404处的环线400开口405可以穿过锁定部分18放置。当牵拉线140穿过开口405时，医疗装置12现在是固定的。图3B示出了朝近侧拉动牵拉线140以开始医疗装置12的释放序列。图3C示出了牵拉线140离开开口405并被拉出环线400的瞬间。环线400的远侧端部404脱离并离开锁定部分18。可以看出，现在没有任何东西将医疗装置12保持在脱离系统10。图3D示出了释放序列的结束。在此，可压缩部分306已经延伸/恢复到其原始形状并且向前“弹出”。远侧管300的远侧端部304向医疗装置12施加弹力E，以将其“推开”，从而确保医疗装置12的完全分离和递送。
上述附图中的图示描绘了根据本发明的大致中空或管状结构100、200、300、500、600。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。
图4是包括用于构造或设计递送构件诸如本文所述的示例性递送构件的方法步骤的流程图。参考图4中概述的方法800，在步骤810中，可以选择第一海波管、第二海波管、柔性套管、线材线圈和抗拉伸构件。第一海波管可以是如本文所述或本领域普通技术人员已知的近侧海波管100。第二海波管可以是如本文所述或本领域普通技术人员已知的远侧海波管300。柔性套管可以是如本文所述或本领域普通技术人员已知的套管或熔合护套500。线材线圈可包括如本文所述或本领域普通技术人员已知的支撑线圈、盘绕区段200。抗拉伸构件可以是如本文所述或本领域普通技术人员已知的抗拉伸构件600。
在步骤820中，可将抗拉伸构件定位在线材线圈的管腔中。在步骤820中，被定位的抗拉伸构件可以是基本上管状的。在步骤830中，第一海波管、线材线圈和第二海波管可以彼此附接。在步骤840中，将抗拉伸构件附接到第一海波管和第二海波管。第一海波管、线材线圈和第二海波管可以如本文所示和所述或通过本领域普通技术人员将理解的其他方式附接。步骤820、830和840不需要以该顺序执行，而是可以同时执行。例如，如步骤840所指示的，抗拉伸构件可以附接到第一海波管和第二海波管中的一者，然后如步骤830所指示的，抗拉伸构件附接到的海波管可以附接到线材线圈，然后如步骤820所指示的，抗拉伸构件可以穿过线材线圈定位，然后如步骤830所指示的，海波管的另一个可以附接到线材线圈，然后如步骤840所指示的，抗拉伸构件可以附接到该另一个海波管。
在步骤850中，线材线圈可以被柔性套管覆盖。柔性套管可以覆盖线材线圈的外表面的一些或全部。步骤850还可以包括将柔性套管熔合到线材线圈和/或以其他方式将柔性套管附连到递送构件的步骤。如果第二海波管具有柔性区段，则在步骤850中，还可以将柔性套管定位成覆盖柔性区段的至少一部分。
在步骤860中，可将植入物可拆卸地附接到第一海波管的远侧端部。在步骤860中，可以通过将环线定位在第一海波管内、定位牵拉线以延伸穿过第一海波管、盘绕线材和第二海波管以及用环线和牵拉线固定植入物来附接植入物。牵拉线可以从第二海波管的近侧端部延伸。如果第一海波管具有可压缩部分，则在步骤860中，可压缩部分可以被压缩，并且植入物可以在可压缩部分被压缩时附接到递送构件。
图5是包括使用包括递送构件(诸如本文所述的示例性递送构件)的系统来施用血管内治疗的方法步骤的流程图。参考图5中概述的方法900，在步骤910中，可以选择一种系统，该系统具有远侧海波管、近侧海波管、同轴地定位在海波管之间的盘绕区段、覆盖盘绕区段的柔性套管、被定位在盘绕区段内的抗拉伸构件、以及附接到远侧海波管或靠近远侧海波管的医学治疗装置。该系统可以适用于如本文所述和所示的或本领域普通技术人员已知的血管内治疗。
在步骤920中，系统可以通过导管移动到治疗部位，诸如动脉瘤或血管中的其他异常的部位。在步骤930中，在系统移动通过导管时系统可弯曲。在步骤940中，可以通过柔性套管和抗拉伸构件防止系统的盘绕区段变形；柔性套管可以抑制盘绕区段径向变形，而抗拉伸构件可以抑制线圈纵向延伸。
在步骤950中，可以部署医学治疗装置。在医学治疗装置是植入物的情况下，在步骤950中，可以分离植入物。在步骤960中，远侧管可以延伸以推动医学治疗装置远离远侧管。在医学治疗装置是在步骤950中分离的植入物的情况下，在步骤960，可以响应于远侧管的扩张将分离的植入物从远侧管弹出。
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，本发明考虑了递送系统、递送构件和接合系统的许多变型和修改，包括部件的另选构造、另选材料、另选医学治疗装置、用于部署医学治疗装置的另选装置、单独部件的另选几何形状、用于附接组件部件的另选装置等。这些修改对于本发明所涉及的领域的普通技术人员来说是显而易见的，并且旨在落入所附权利要求的范围内。

Claims (18)

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递送构件，所述递送构件包括：
远侧海波管，所述远侧海波管包括成形为接纳所述植入式医疗装置的远侧端部；
支撑线圈区段，所述支撑线圈区段附连到所述远侧海波管的近侧端部；
近侧海波管，所述近侧海波管附连到所述支撑线圈区段的近侧端部；
管腔，所述管腔延伸穿过所述远侧海波管、所述支撑线圈区段和所述近侧海波管；
柔性套管，所述柔性套管至少覆盖所述支撑线圈区段的大部分外表面；和
抗拉伸构件，所述抗拉伸构件延伸穿过所述管腔的一部分，所述抗拉伸构件附连到所述近侧海波管并附连到所述远侧海波管。
2.根据权利要求1所述的递送构件，还包括：
接合系统，所述接合系统能够移动以接合并部署接合在所述远侧海波管的远侧端部处的所述植入式医疗装置，所述接合系统包括：
环线，所述环线延伸穿过所述植入式医疗装置中的开口，由此将所述接合系统接合到所述植入式医疗装置，并且能够移动以从所述植入式医疗装置中的所述开口回缩以部署所述植入式医疗装置，和
牵拉线，所述牵拉线延伸穿过所述管腔，接合到所述环线，由此将所述接合系统接合到所述植入式医疗装置，并且能够移动以朝近侧回缩以脱离接合所述环线，以部署所述植入式医疗装置。
3.根据权利要求2所述的递送构件，
其中，所述远侧海波管包括可压缩部分，所述可压缩部分能够从压缩状态移动到伸长状态，并且
其中当接合到所述植入式医疗装置时，所述接合系统将所述可压缩部分保持在所述压缩状态。
4.根据权利要求1所述的递送构件，其中，所述支撑线圈区段包括：
从所述支撑线圈区段的所述近侧端部延伸的非不透射线的近侧线圈；
从所述支撑线圈区段的所述远侧端部延伸的非不透射线的远侧线圈；和
在所述非不透射线的近侧线圈和所述非不透射线的远侧线圈之间延伸的不透射线的中央线圈。
5.根据权利要求1所述的递送构件，其中，所述支撑线圈区段包括：
卷绕以形成所述支撑线圈区段并限定所述管腔的一部分的线材，所述线材具有从约0.0008英寸至约0.005英寸的直径。
6.根据权利要求1所述的递送构件，
其中，所述柔性套管包括聚合物，并且
其中所述柔性套管包括有效增加所述聚合物的润滑性的添加剂。
7.根据权利要求1所述的递送构件，其中，所述柔性套管附连到所述近侧海波管和所述远侧海波管。
8.根据权利要求1所述的递送构件，其中，所述抗拉伸构件是挤压管。
9.根据权利要求1所述的递送构件，其中，所述递送构件具有能够从所述支撑线圈区段的所述近侧端部到所述远侧海波管的所述远侧端部测量的长度，并且其中所述长度为约40cm。
10.根据权利要求1所述的递送构件，其中，所述近侧海波管包括螺旋切割部分，所述螺旋切割部分接近所述近侧海波管的远侧端部。
11.一种构造用于递送植入式医疗装置的递送构件的方法，所述方法包括：
选择第一海波管，所述第一海波管包括穿过其的第一管腔；
选择第二海波管，所述第二海波管包括穿过其的第二管腔；
形成从所述第二海波管的远侧端部延伸至所述第一海波管的近侧端部的线材线圈区段，使得所述线材线圈区段限定穿过其的第三管腔；
将抗拉伸构件延伸穿过所述第三管腔；
将所述抗拉伸构件附连到所述第一海波管和所述第二海波管；
选择柔性套管；
用所述柔性套管至少覆盖所述支撑线圈区段的大部分所述外表面；以及
将所述植入式医疗装置可拆卸地附接到所述递送构件接近所述第一海波管的远侧端部。
12.根据权利要求11所述的方法，其中形成所述线材线圈区段的步骤还包括：
形成从所述第二海波管的所述远侧端部朝远侧延伸的非不透射线的近侧线圈；
形成从所述第一海波管的所述近侧端部朝近侧延伸的非不透射线的远侧线圈；以及
形成在所述非不透射线的近侧线圈和所述非不透射线的远侧线圈之间延伸的不透射线的中央线圈。
13.根据权利要求11所述的方法，其中形成所述线材线圈区段的步骤还包括：
选择具有从约0.0008英寸至约0.005英寸的直径的线材；以及
卷绕所述线材以形成所述线材线圈区段并限定穿过其的所述管腔。
14.根据权利要求11所述的方法，其中选择所述柔性套管的步骤还包括：
选择包括聚合物和有效增加所述聚合物的润滑性的添加剂的柔性套管。
15.根据权利要求11所述的方法，其中将抗拉伸构件延伸穿过所述第三管腔的步骤还包括：
将基本上管状的所述抗拉伸构件延伸穿过所述第三管腔。
16.根据权利要求11所述的方法，其中将所述植入式医疗装置可拆卸地附接到所述递送构件接近所述第一海波管的远侧端部的步骤还包括：
压缩所述第一海波管；以及
将所述植入式医疗装置可拆卸地附接到所述递送构件接近所述压缩的第一海波管的所述远侧端部。
17.根据权利要求11所述的方法，还包括：
将环线定位在所述第一管腔内；以及
定位牵拉线以延伸穿过所述第一管腔、所述第三管腔和所述第一管腔，
其中将所述植入式医疗装置可拆卸地附接到所述第一海波管的远侧端部的步骤还包括：
将所述环线延伸穿过所述植入式医疗装置中的开口；以及
将所述牵拉线接合到延伸穿过所述植入式医疗装置中的所述开口的所述环线的一部分。
18.根据权利要求17所述的方法，其中将所述植入式医疗装置可拆卸地附接到所述第一海波管的远侧端部的步骤还包括：
将所述牵拉线定位成从所述第二海波管的近侧端部朝近侧延伸。
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US20220118220A1 (en) 2022-04-21
US11207494B2 (en) 2021-12-28
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US20210001082A1 (en) 2021-01-07
US20210213252A1 (en) 2021-07-15
JP7532117B2 (ja) 2024-08-13
KR20210004853A (ko) 2021-01-13
EP3760139A3 (en) 2021-01-20
ES2923603T3 (es) 2022-09-28
EP3760139B1 (en) 2022-06-01

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