CN109789295B - 具有可成形聚合物末端的导丝装置 - Google Patents

具有可成形聚合物末端的导丝装置 Download PDF

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CN109789295B
CN109789295B CN201780057199.3A CN201780057199A CN109789295B CN 109789295 B CN109789295 B CN 109789295B CN 201780057199 A CN201780057199 A CN 201780057199A CN 109789295 B CN109789295 B CN 109789295B
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tube structure
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guidewire device
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约翰·A·李波特
爱德华杰·斯奈德
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Vascular Sciences Corp
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Abstract

本公开涉及具有可成形末端和有效扭转能力的导丝装置。导丝装置包括具有近侧区段和逐渐变细的远侧区段的芯。管结构联接到芯，使得芯的逐渐变细的远侧区段延伸到管结构中并且向远侧延伸超过管结构。芯的向远侧延伸超过管的部分形成可成形末端。聚合覆盖物包裹末端。末端被构造成减小来自管结构的弹性力破坏末端的定制形状的趋势。

Description

具有可成形聚合物末端的导丝装置
相关申请的交叉引用
本申请要求2017年6月1日提交的题为“GUIDEWIRE DEVICES HAVING SHAPEABLEPOLYMER TIPS(具有可成形聚合物末端的导丝装置)”的美国专利申请序列号15/611,344以及2016年7月18日提交的题为“GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS(具有可成形末端的导丝装置)”的美国临时专利申请序列号62/363,760的优先权和权益。所有上述申请均通过引用整体并入本文。
背景技术
导丝装置通常用于将导管或其他介入装置导引或引导至患者体内的目标解剖位置。通常，导丝进入并通过患者的脉管系统以便到达目标位置，该目标位置例如可以在患者的心脏或神经血管组织处或附近。通常使用放射摄影成像来帮助将导丝导航到目标位置。在许多情况下，在介入手术期间导丝留在身体内的适当位置，其中导丝可用于将多个导管或其他介入装置引导到目标解剖位置。
一些导丝装置被构造成具有弯曲或弯折的末端，以使操作者能够更好地导航(navigate，走行)于患者的脉管系统。利用这种导丝，操作者能将扭矩施加到导丝的近端或所附接的近侧手柄，目的是将末端朝向并指向期望的方向。然后，操作者可以在患者的脉管系统中在期望的方向上进一步导向导丝。
调整导丝装置(特别是导丝装置的远侧区段)的柔性也是一个问题。在许多情况下，相对高水平的柔性是期望的，目的是提供给导丝足够的可弯折性，以使导丝能够成角度地通过脉管系统通道的曲折的弯折和弯曲而到达目标区域。例如，将导丝导向到神经血管系统的部分需要导丝通过弯曲的通道，诸如颈动脉虹吸部和其他曲折路径。
与导丝装置有关的另一个问题是给定导丝装置从近端向远端传递扭矩的能力(即，导丝装置的“扭转能力”)。随着导丝的更多部分进入并穿过脉管系统通道，导丝与脉管系统之间的摩擦表面接触量增加，阻碍导丝容易地移动通过脉管系统通道。具有良好扭转能力的导丝使得近端处的扭矩力能够通过导丝被传递到远端，从而使得导丝能够旋转并克服摩擦力。
一些导丝装置包括位于导丝芯的远端上方的远侧放置的微机械加工的海波管(hypotube)，目的是朝向装置的端部进一步向远侧导向所施加的扭转力。因为主要通过构件的横截面的外部区段传递扭转力，所以管被构造成提供一路径，从而用于传递与未被管套住的导丝芯所传递的扭矩量相比增加的扭矩。
虽然所述导丝装置提供了许多益处，但仍存在若干局限性。例如，具有扭矩传递管的导丝的许多设计特征，虽然起到提供增加的扭矩传递的作用，但是其不利于且限制了导丝末端的可成形性。
发明内容
本公开涉及具有可成形末端和有效扭矩的导丝装置。在一个实施例中，导丝装置包括具有近侧区段和远侧区段的芯。远侧区段可以逐渐变细到比近侧区段处更小的直径。管结构联接到芯，使得芯的远侧区段进入管结构并向远侧超出管结构之外以形成可成形末端。导丝装置还包括线圈，该线圈包裹芯的远侧部分的至少一部分。线圈定位成使得线圈的近侧部分设置在芯的外表面与管结构的内表面之间，并且使得线圈的远侧部分向远侧延伸超过管结构以包裹可成形末端的至少一部分。导丝装置还包括聚合覆盖物，该聚合覆盖物包裹线圈的远侧部分的至少一部分。末端被构造成减小来自管结构的弹性力破坏末端的定制形状的趋势。
在一些实施例中，导丝装置还包括编织材料，该编织材料联接到管结构的远端并从管结构向远侧延伸。在一些实施例中，编织材料嵌入聚合覆盖物内。
在一个实施例中，芯由不锈钢形成和/或包括所述不锈钢，管结构由超弹性材料(诸如镍钛诺(nitinol，镍钛合金))形成和/或包括所述超弹性材料，并且线圈由不透射线的材料(诸如铂)形成和/或包括所述不透射线的材料。
在一些实施例中，管结构包括多个窗孔(fenestration)，所述窗孔限定与多个周向延伸的环联接的多个轴向延伸的梁。管结构可包括单梁切口图案、双梁切口图案、三梁切口图案、或多于三个梁的切口图案中的一种或多种。在一些实施例中，在连续的段之间施加旋转的偏移，以使沿管结构长度的优选弯曲方向最小化。
另外的特征和优点将部分地在下面的描述中阐述，并且从描述中部分地显而易见，或者可以通过本文公开的实施例的实践来学习。借助于所附权利要求中特别指出的元件和组合，将明白和获得本文公开的实施例的目的和优点。应理解，前述简要概述和以下详细描述都仅是示例性和解释性的，而不限制本文公开的或如所要求保护的实施方案。
附图说明
为了描述可以获得本发明的上述和其他优点和特征的方式，将通过参考附图中所示的具体实施例来给出上面简要描述的本发明的更具体的描述。应理解，这些附图仅描绘了本发明的典型实施例，因此不应认为是对其范围的限制，本发明将通过使用附图用附加的特征和细节来描述和解释，在附图中：
图1A和图1B示出了导丝装置的示例性实施例，该导丝装置提供有效的扭转能力并具有包裹可成形末端的聚合物；
图2示出了导丝装置的另一个实施例，该导丝装置具有可成形末端，其中编织材料嵌入聚合覆盖物内；
图3至图8示出了可以在导丝装置的管中形成的各种示例性切口图案；以及
图9至图11示出了可与导丝装置一起使用的各种远侧末端构造。
具体实施方式
介绍
本公开涉及提供有效解剖学导航性能的导丝装置。将导丝引导和导向至目标解剖位置的能力取决于平衡和最优化扭转能力与维持成形末端的能力之间的权衡。导丝装置可包括可成形末端，以允许操作者通过旋转远侧末端而将该末端指向脉管系统内的期望方向。然而，如果这种导丝装置的扭转能力不足，则操作者将不能将扭转力一直传递到成形的远侧末端以控制成形的远侧末端的定向。随着导丝装置进一步进入脉管系统并且受到增大的摩擦阻力，这种障碍将变得越来越成问题。另外，如果导丝装置不能正确地形成并维持成形末端，则其调整末端定向的能力有限，使得血管内导航更加困难。
本文描述的实施例提供平衡和/或最优化导丝扭转能力与形成和维持成形末端的能力之间的关系的一个或多个特征。所述导丝在导丝部署期间响应操作者操纵，并且通过使成形的远侧末端能够接收传递的扭转力来提供有效的导航性能。
在一些实施例中，可成形末端允许操作者诸如通过在将导丝装置部署在患者脉管系统内之前使末端手动成形而定制可成形末端。因此，操作者能够根据给定应用的特有的条件和/或偏好来定制远侧末端的成形。导丝装置还被构造成在维持成形末端的同时有效地传递扭矩。本文描述的至少一些实施例包括这样的末端，所述末端能够在整个手术过程中或在多个手术过程中或甚至无限期地维持弯折或弯曲形状，直至受到反作用的再成形力。
具有可成形末端的导丝装置
图1A和图1B示出了具有有效可成形末端的示例性导丝装置100。图1A示出了该装置的侧视图，图1B示出了该装置的横截面视图。导丝装置100包括芯102。管104联接到芯102并从与芯102的附接点向远侧延伸。如图所示，芯102的远端区段延伸到管104中并被管104围绕。在一些实施例中，芯102包括一个或多个逐渐变细的区段，使得芯102能够装配在管104内并延伸到该管中。例如，芯102的远侧区段可以被研磨，以便逐渐变细至远端处的更小直径。在该示例中，芯102和管104在它们相邻并彼此附接的附接点103处具有基本上相似的外径。
管104以允许扭转力从芯102传递到管104并由此进一步通过管104向远侧传递的方式联接到芯102(如，使用粘合剂、钎焊(soldering)和/或焊接(welding))。医用级粘合剂/聚合物可用于在一个或多个点(如，包括附接点103)将管104联接到芯线102。
如下面更详细地解释的，管104被微制造成包括多个切口。切口布置成形成一切口图案，该切口图案可有利地在导丝装置100的远侧末端附近提供有效的可成形性，同时还维持良好的扭转能力。为清楚起见，在图1A至图2中未示出切口图案，但将参照图3至图8对其进行描述。
在一些实施例中，导丝装置100的近侧区段110向近侧延伸至一长度，该长度为提供足够的导丝长度以递送至目标解剖区域所需。近侧区段110通常具有约50cm至300cm(约19.69英寸至118.11英寸)范围内的长度。近侧区段110可具有约0.36mm(约0.014英寸)的直径，或约0.20mm至3.175mm(约0.008英寸至0.125英寸)范围内的直径。芯102的远侧区段112可以逐渐变细至约0.051mm(约0.002英寸)的直径，或者约0.025mm至1.27mm(约0.001英寸至0.050英寸)范围内的直径。在一些实施例中，管104的长度在约3cm至100cm(约1.18英寸至39.37英寸)的范围内。管104可以由超弹性材料(诸如镍钛诺)形成和/或包括所述超弹性材料。可替代地，管104可以由线性弹性材料(如，具有至少约6％的可恢复应变)形成和/或包括所述线性弹性材料。装置的向远侧延伸超过管104的部分(称为末端106)的长度可测量为约0.5cm至5cm，或长度测量为约1cm至3cm。
在一些实施例中，芯102的远侧区段112逐渐变细为圆形横截面。在其他实施例中，芯102的远侧区段112具有扁平或矩形横截面。远侧区段112还可以具有另一横截面形状，诸如另一多边形形状、卵形形状、不规则形状，或沿着其长度的不同区域处的不同横截面形状的组合。
通常，使用者将通过手动弯折、扭曲或以其他方式将导丝装置100的远端(约)1cm至3cm处理成期望形状来成形导丝装置100的远端。图示的导丝装置100包括远侧末端106，该远侧末端向远侧延伸超过管104。末端106被构造成可成形的，使得操作者可以手动地弯折、扭曲或以其他方式将末端106处理成期望的形状。在一些实施例中，末端106包括由不锈钢、铂和/或其他可成形材料形成的一个或多个可成形部件。在优选实施例中，末端106包括由显示出加工硬化特性的材料形成的一个或多个部件，使得末端在成形(即，塑性变形)时在成形区段提供比成形之前更高的弹性模量。
线圈114部分地定位于管104内，位于芯102的远侧区段112的至少一部分上。线圈114向远侧延伸超过管104以形成末端106的一部分。线圈114优选地由一种或多种不透射线的材料形成，诸如铂族、金、银、钯、铱、锇、钽、钨、铋、镝、钆等等。另外或替代地，线圈114可以至少部分地由不锈钢或由在被使用者弯折或以其他方式处理之后能有效地保持形状的其他材料形成。
在所示实施例中，线圈114设置在装置的远端处或其附近，并且朝向附接点103向近侧延伸一段距离。在所示装置中，线圈114的大部分长度向远侧延伸超出管104。在其他实施例中，线圈114可以向近侧进一步地延伸。线圈114可以从远端延伸1cm、2cm、4cm、6cm、8cm、10cm、12cm、15cm、20cm、25cm、30cm或35cm，或者可以延伸由前述值中的任何两个值限定的范围中的一段距离。
在一些实施例中，线圈114的向远侧延伸超过管104的区段可以由与线圈114的更近侧区段不同的材料形成。例如，线圈114的远侧区段可以由不锈钢和/或首选提供有效可成形性的其他材料形成，而线圈114的近侧区段由铂或首选提供有效射线不透性的其他材料形成。在一些实施例中，线圈114形成为一个整体件。在其他实施例中，线圈114包括彼此相邻堆叠定位和/或通过相互交织的线圈互锁的多个独立区段。另外或替代地，这些独立区段可以钎焊、粘附或以其他方式彼此紧固以形成完整的线圈114。
尽管所示实施例示出了线圈114的外表面与管104的内表面之间的空间，但是应该理解，这是为了便于可视性而示意性地示出的。在一些实施例中，线圈114的尺寸设计成充塞芯102与管104之间的较大比例的空间。例如，线圈114的尺寸可以设计成既紧靠芯102的外表面也紧靠管104的内表面。一些实施例在芯102与管104之间可以包括用于导丝装置100的至少一部分区段的空间，管104和芯102在此处共同延伸。
线圈114的设置在管104内的部分可以有利地用于填塞芯102与管104之间的空间，以使芯102的远侧区段112的曲率与管104的曲率一致(align with，对准)。例如，当在管104中形成曲率时，紧密填塞的线圈114的区段用作管104与远侧区段112之间的填塞物，以赋予远侧区段112相同的曲率。相反，省却了这种填塞物的导丝装置的芯可以不遵循与管相同的弯曲，而是可以延伸直到抵靠管的内表面，之后被迫弯曲。
如图所示，末端106比管104更向远侧延伸。所示的构造有利地允许末端106相对于管104和导丝100的其余部分成形为期望的位姿(position)并且在成形位姿保持足够长的时间段。与依赖于管的可成形性或依赖于更完全地布置在管内的可成形部件的导丝装置相比，所示的末端106能够维持成形构造而不受管104自身施加的反作用力。
另外，如下面更全面地描述的，管104可以包括切口图案，该切口图案维持有效的扭转能力，同时还在管104的远侧区域处提供足够的柔性，以避免破坏末端106的定制形状。在优选实施例中，芯的可成形远侧区段具有刚度，该刚度能经受作用于芯的成形后的远侧区段的来自管的预期弯折力。在一些实施例中，芯的可成形远侧区段由提供比用于形成管的材料的弹性模量大了约1.5至4倍或约2至3倍的弹性模量的材料或材料组合形成。
与所示实施例相反，依赖于管的成形来提供期望的远侧末端形状的导丝装置将不能够保持成形构造或者仅能够在相对较短的时间段内保持成形构造。因为管结构通常由镍钛诺或其他超弹性材料形成，所以对成形末端的这种退化作用至少部分地发生。这些管在弯折或成形时将被偏向其原始(如，直的)位姿，并将对任何可成形的内部部件施加恢复力，导致末端的变形和定制形状的损失。
通常，例如，在远侧终止于管结构或者另外基本上依赖于管结构的弯折以使末端成形的导丝将在部署之前具有成形末端。然而，在使用导丝期间，成形末端将丢失或退化，因为超弹性管朝向与期望的末端形状相反的其原始形状折曲。相比之下，本文描述的实施例提供了末端可成形的能力，而不会使导丝装置的相邻部件受到变形恢复力。
所示的导丝装置100还包括由医用级聚合物材料形成的外部聚合覆盖物118。聚合覆盖物118粘接至并包裹线圈114和芯102的向远侧延伸的区段。聚合覆盖物118有利地提供具有高相对柔性的无创伤覆盖物。高相对柔性允许末端106定制成形而不受到反作用的弹性或超弹性恢复力。如图所示，形成聚合覆盖物118的聚合物材料也可以在芯102的远端末端上延伸，以形成无创伤终端120。
在一些实施例中，聚合覆盖物118掺杂有不透射线的物质，诸如钡、铋、钨等。例如，在线圈114由相对较低不透射线的材料(如，不锈钢)形成的实施例中，聚合覆盖物118可以构造成为末端106提供足够的射线不透性。
在一些实施例中，用于形成聚合覆盖物118的聚合物粘接到管104的一或多个内部部分。例如，一定量的聚合物材料可定位在管104内以帮助填塞芯102与管104之间的空间。在一些实施例中，聚合物可以用作由线圈114提供的一些或全部填塞的替代物，使得线圈可以被省却或相对于外部直径、线圈线尺寸、线圈间距和/或长度被调整。
医用级聚合物材料可由一或多种医用级粘合剂形成和/或包括所述一或多种医用级粘合剂。在一些实施例中，例如，聚合物材料可以是通过应用紫外和/或可见光可固化的丙烯酸酯基粘合剂。聚合物材料还可包括一或多种弹性体填料、粘合促进剂、流平剂和/或固化促进剂。
图2示出了导丝装置200的替代实施例，该导丝装置具有形成可成形末端206一部分的聚合物覆盖编织区段218。导丝装置200可以以与图1的导丝装置100类似的方式构造，并且类似的附图标记表示类似的特征/部件。因此，导丝装置200包括具有近侧区段210和远侧区段212的芯202。远侧区段212延伸到管204中并且向远侧延伸超过所述管以形成可成形末端206。管204可以在粘附点203处粘附至芯202。由不透射线的和/或可成形的材料形成的线圈214包裹芯202的至少一部分，该至少一部分向远侧延伸超过管204，并且可以向近侧延伸以部分地位于管204内。
在该实施例中，远侧末端206包括聚合物覆盖编织物218。编织物218至少围绕线圈214的远侧延伸部分并且可以用作聚合物材料的嵌入结构。编织物218有利地提供成从管204到远侧末端206传递一些扭矩，同时仍提供有效的柔性，允许末端206维持在成形构造。编织物218可以由合适的金属网材料形成和/或可以包括所述合适的金属网材料，诸如不锈钢网。其中编织物218嵌入于其中的聚合物材料可包括不透射线的填料，诸如硫酸钡和/或本文所述的任何其他不透射线的材料。
切口图案
图3至图8示出了可以在本文描述的一个或多个导丝装置实施例中使用的管切口图案的示例性实施例。例如，可以根据图3至图8中所示的一种或多种构造来切割图1和图2中所示实施例的管104。
本文根据设置在每对相邻的周向延伸环之间的轴向延伸梁的数目来命名切口图案。图3和图4示出了“单梁”切口图案，图5和图6示出了“双梁”切口图案，图7示出了“三梁”切口图案。其他实施例可以在每对相邻环之间包括多于三个梁(如，四梁切口图案，五梁切口图案等)。
图3中所示的管结构304包括设置在每对相邻环334之间的单个梁332。成对的相邻梁可以交替180度，如图所示。附加地或替代地，区段可以包括沿着管的长度定位在单侧上的梁，如由图4的管404的梁432和环434所示。
图5中所示的管结构504包括设置在每对相邻环534之间的一对周向相对的梁532。每对梁中的相应梁532可以对称地沿周向间隔开(即，大约180度)，如图5所示。替代地，相应的梁可以是周向非对称的，如由图6的管604的梁632和环634所示。图7中所示的管结构704包括设置在每对相邻环734之间的三元组(a triad of，三个一组)的梁732。如图所示，每个三元组中的相应梁可以对称地周向间隔开(即，大约120度)，或者可以根据一些非对称布局来定位。
通常，每对相邻环之间留下的梁的数量越多，管的刚度就越大。因此，可以选择切口图案以沿着管的长度提供所需的柔性轮廓(profile)。切割间隔、宽度和/或深度也可以改变，以提供所需的柔性特性。例如，一种管构造可包括具有相对较低柔性和相对较高扭转能力的近侧区段，其快速进展为具有相对较高柔性和相对较低扭转能力的远侧区段。有利地，由这种切口图案提供的柔性可以阻止或最小化管导致导丝(如，芯)的内部结构的形状变形，使得可以更好地形成和维持末端的定制形状。
具有基本上周向等距间隔的梁的双梁切口图案的管的一区段(如图5中所示)通常具有相对较高的传递扭矩的能力和相对较低的柔性，而具有非对称间隔梁的管的区段(如图6所示)的扭矩传递性和柔性通常在对称间隔梁图案与单梁图案(如图3所示)之间。对应的一对梁定位得周向对称性越小，所得到的梁将在周向上越靠近，因此该非对称双梁切口图案将与单梁切口图案越相似。因此，这种非对称双梁图案可以用作对称双梁图案与单梁图案之间的过渡。
切口图案可以沿着管的长度形成重复结构单元的“段”。在典型的单梁实施例中，单个段可以被限定为设置在两个相邻环334(一个近侧环和一个远侧环)之间的第一梁332和从远侧环延伸并且相对于第一梁332旋转偏移大约180度的第二相对梁332。类似地，在典型的双梁实施例中，单个段可以被限定为设置在两个相邻环534(一个近侧环和一个远侧环)之间的第一对梁532，以及从远侧环延伸并且相对于第一对梁旋转偏移大约90度的第二对梁532。类似地，在典型的三梁实施例中，单个段可以被限定为设置在两个相邻环734(一个近侧环和一个远侧环)之间的第一三元组梁732和从远侧环延伸并且相对于第一三元组梁旋转偏移约60度的第二三元组梁732。
图8示出了具有多个梁832和环834的管804。所示的切口图案包括在管804的每个连续段处施加的旋转偏移，以使得管中的优选弯折方向最小化。当用在本文中时，“旋转偏移”是两个相邻段之间的角度旋转。因此，从一个段到下一个段应用旋转偏移，甚至是一段内各个切口也可以彼此偏移。
如图所示，切口可以布置成从一个段到下一个段形成基本一致的旋转偏移。所示的切口图案示出了从一个段到下一个段约5度的旋转偏移。当形成具有这种角度偏移的多个连续段时，沿着管804的足够长度所形成的梁的图案以连续旋转的螺旋图案围绕管804的轴线缠绕。角度偏移可以是大约5度、15度、30度、45度、60度、75度、80度或85度。在一些实施例中，在每个连续的段处应用角度偏移。在其他实施例中，多个连续的段没有偏移地彼此相邻设置，之后施加角度偏移。
所示示例示出了具有一系列旋转偏移的双梁切口图案。然而，应该理解的是，相同的原理可以应用于其他切口图案，诸如每对相邻环中具有单梁切口图案、三梁切口图案，或具有多于三个梁的切口图案。在优选实施例中，沿给定区段的长度的每个连续切口或切口组(如，每第二切口、每第三切口、每第四切口等)旋转偏移约1度、2度、3度、5度或10度，或者在单梁图案中从180度偏移约1度、2度、3度、5度或10度，在双梁图案中从90度偏移1度、2度、3度、5度或10度，在三梁图案中从60度偏移1度、2度、3度、5度或10度，对于具有更多梁数量的图案以此类推。这些旋转偏移值有利地示出消除折曲偏差的良好能力。
可以组合图3至图8中所示的切口图案的单独部件和特征以形成不同的管构造。例如，一些管可以构造成具有过渡到单梁切口区段的双梁切口区段。
末端变型例
图9至图11示出了可与本文所述的一个或多个实施例一起使用的各种远侧末端构造的实施例。图9示出了连续直径末端构造。在围绕逐渐变细的芯902的线圈918处具有基本上连续的直径。图10示出了阶梯式末端构造，其中定位在芯1002上方的外部线圈1018具有基本上连续的直径。较小直径的内部线圈1014定位成比外部线圈1018更向远侧延伸，以提供末端直径的阶梯式变化。图11示出了逐渐变细的末端构造，其中线圈1118逐渐变细，以匹配芯1102的至少一部分锥部。图9至图11中所示的末端实施例可以与本文所述的任何导丝装置实施例组合。例如，可以选择期望的末端构造，以便为给定的导丝应用提供期望的可成形性和/或柔性特性。
本文使用的术语“大约”、“约”和“基本上”表示接近所述量或条件的量或条件，其仍然执行期望的功能或实现期望的结果。例如，术语“大约”、“约”和“基本上”可以指从所述量或条件偏离小于10％，或小于5％，或小于1％，或小于0.1％，或小于0.01％的量或条件。
关于本文描绘和/或描述的任何实施例所描述的元件可以与关于本文描绘和/或描述的任何其他实施例所描述的元件组合。例如，关于图3至图8中的任一个的管区段所描述的任何元件和/或关于图9至图11中的任一个的末端构造所描述的任何元件可以相组合，并且与图1A、图1B和图2的导丝装置一同使用。在任何前述组合中，芯线的远侧末端可以是圆形的、扁平的或其他形状。
在不脱离本发明的构思或基本特征的情况下，本发明可以以其他形式实施。所描述的实施例在所有方面都应被视为仅是说明性的而非限制性的。因此，本发明的范围由所附权利要求而不是前面的描述表示。落在权利要求的含义和等同范围内的所有变化都包括在其范围内。

Claims (14)

1.一种具有可成形末端的导丝装置，所述导丝装置包括：
芯，所述芯具有近侧区段和远侧区段，所述远侧区段具有比所述近侧区段小的直径；
管结构，所述管结构联接到所述芯，以使得所述芯的远侧区段进入所述管结构并向远侧超出所述管结构之外以形成可成形末端的一部分，其中所述芯包括逐渐变细的区段，其中所述管结构附接到所述逐渐变细的区段上的附接点处，并且其中所述芯和所述管结构在所述附接点处具有基本上相似的外径；
线圈，包裹所述芯的远侧区段的一部分，所述线圈部分地设置在所述管结构内并且部分地向远侧延伸超过所述管结构以形成所述可成形末端的一部分，其中，所述线圈的尺寸被设定为既紧靠所述芯的外表面也紧靠所述管结构的内表面，使得所述线圈的尺寸和形状被构造为填塞所述芯与所述管结构之间的空间，使得当所述管结构中形成曲率时，所述线圈对所述芯的重合部分赋予相同的曲率；
编织材料，联接到所述管结构的远端并从所述管结构向远侧延伸；以及
聚合覆盖物，所述聚合覆盖物包裹所述线圈向远侧延伸超过所述管结构的部分并且形成所述可成形末端的至少一部分，所述可成形末端构造成用于相对于所述管结构成形为成形构造，并且构造成保持所述成形构造而不受所述管结构施加的反作用力。
2.根据权利要求1所述的导丝装置，其中，所述可成形末端向远侧延伸超过所述管结构0.5cm至5cm的距离，或1cm至3cm的距离。
3.根据权利要求1所述的导丝装置，其中，所述线圈的设置在所述管结构内的部分包裹所述芯并且定位在所述芯的外表面与所述管结构的内表面之间。
4.根据权利要求1所述的导丝装置，其中，所述线圈由不透射线的材料形成。
5.根据权利要求1所述的导丝装置，其中，所述管结构由镍钛诺形成。
6.根据权利要求1所述的导丝装置，其中，所述芯由不锈钢形成。
7.根据权利要求1所述的导丝装置，其中，所述聚合覆盖物包括不透射线的材料。
8.根据权利要求1所述的导丝装置，其中，所述编织材料嵌入所述聚合覆盖物内。
9.根据权利要求1所述的导丝装置，其中，所述管结构包括多个窗孔，所述多个窗孔限定与多个周向延伸的环联接的多个轴向延伸的梁。
10.根据权利要求9所述的导丝装置，其中，所述多个窗孔被布置成单梁切口图案、双梁切口图案或三梁切口图案中的一种或多种。
11.根据权利要求9所述的导丝装置，其中，所述窗孔限定具有旋转偏移的切口图案，使得沿着所述管结构的长度的每个连续段自前一段周向旋转。
12.根据权利要求9所述的导丝装置，其中，所述窗孔限定具有切口的图案，所述切口具有朝向所述管结构的远端增加的深度和/或在连续切口之间具有朝向所述管结构的远端减小的间隔。
13.一种具有可成形末端的导丝装置，所述导丝装置包括：
芯，所述芯具有近侧区段和远侧区段，所述远侧区段具有比所述近侧区段小的直径；
管结构，所述管结构联接到所述芯，以使得所述芯的远侧区段进入所述管结构并向远侧超出所述管结构之外以形成可成形末端，其中所述管结构包括多个窗孔，所述窗孔限定多个轴向延伸的梁和周向延伸的环；
线圈，所述线圈包裹所述芯的远侧区段的至少一部分，所述线圈的一部分设置在所述芯的外表面与所述管结构的内表面之间，并且所述线圈的一部分向远侧延伸超过所述管结构以形成所述可成形末端的至少一部分，其中所述线圈的长度的向远侧延伸超过所述管结构的部分比设置在所述芯的外表面与所述管结构的内表面之间的部分更长，其中所述线圈的尺寸被设定为既直接紧靠所述芯的外表面也直接紧靠所述管结构的内表面，使得所述线圈的尺寸和形状被构造为填塞所述芯与所述管结构之间的空间，使得当所述管结构中形成曲率时，所述线圈对所述芯的重合部分赋予相同的曲率；
编织材料，联接到所述管结构的远端并从所述管结构向远侧延伸；以及
聚合覆盖物，所述聚合覆盖物联接到所述管结构的远端并从所述管结构向远侧延伸，所述聚合覆盖物包裹所述线圈的向远侧延伸超过所述管结构的部分且形成所述可成形末端的至少一部分，所述可成形末端构造成用于相对于所述管结构成形为成形构造，并且构造成保持所述成形构造而不受所述管结构施加的反作用力。
14.一种使用具有可成形末端的导丝装置的方法，该方法包括：
提供导丝装置，所述导丝装置包括：
芯，所述芯具有近侧区段和远侧区段，所述远侧区段具有比所述近侧区段小的直径，
管结构，所述管结构联接到所述芯，以使得所述芯的远侧区段进入所述管结构并向远侧超出所述管结构之外以形成可成形末端的一部分，其中所述管结构包括多个窗孔，所述窗孔限定多个轴向延伸的梁和周向延伸的环，其中所述芯包括逐渐变细的区段，其中所述管结构附接到所述逐渐变细的区段上的附接点处，并且其中所述芯和所述管结构在所述附接点处具有基本上相似的外径，
线圈，所述线圈包裹所述芯的远侧区段的至少一部分，所述线圈的一部分设置在所述芯的外表面与所述管结构的内表面之间，并且所述线圈的一部分向远侧延伸超过所述管结构以形成所述可成形末端的至少一部分，其中，所述线圈的尺寸被设定为既紧靠所述芯的外表面也紧靠所述管结构的内表面，使得所述线圈的尺寸和形状被构造为填塞所述芯与所述管结构之间的空间，使得当所述管结构中形成曲率时，所述线圈对所述芯的重合部分赋予相同的曲率，
编织材料，联接到所述管结构的远端并从所述管结构向远侧延伸；及
聚合覆盖物，所述聚合覆盖物联接到所述管结构的远端并从所述管结构向远侧延伸，所述聚合覆盖物包裹所述线圈的向远侧延伸超过所述管结构的部分；
成形所述可成形末端，以及
相对于所述管结构将所述可成形末端成形为定制形状，使得所述可成形末端响应于来自所述管结构在成形所述可成形末端之后作用在所述芯的远侧区段的弯曲力而相对于所述管结构保持所述定制形状。
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