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CN105578989B - 下腔静脉过滤器及其收回系统 - Google Patents

下腔静脉过滤器及其收回系统 Download PDF

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CN105578989B
CN105578989B CN201480033908.0A CN201480033908A CN105578989B CN 105578989 B CN105578989 B CN 105578989B CN 201480033908 A CN201480033908 A CN 201480033908A CN 105578989 B CN105578989 B CN 105578989B
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CN105578989A (zh
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F·P·贝金
K·A·斯特科
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ALTAI MEDICAL TECHNOLOGIES
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

本发明描述了由定型(例如，热定型)编织物制成的漏斗捕获器类型的器件，其用于输送和/或收回下腔静脉(IVC)过滤器或其他医疗器件。输送和/或收回器件、包括它们的套件、使用方法和制造方法都是本文可预料到的。

Description

下腔静脉过滤器及其收回系统
技术领域
本文所述的实施方式涉及血管内(经皮输送的)下腔静脉(IVC)过滤器器件和方法，特别地是用于暂时性IVC过滤器。
背景技术
暂时性IVC过滤器被放置成非常类似于永久性过滤器，但其设计以使得它们可以通过单独的血管内过程中收回，通常从股静脉或颈内静脉通道。多数当前可用的暂时性过滤器包括钩状特征，它们通过钩状特征能够被获取并接收到导管或护套内，用于通过利用鹅颈勒除器或多环勒除器移除。
虽然收回在原理上是简单的过程，通常遇到的困难是利用(一个或多个)勒除器环获取过滤器的钩。在过滤器倾斜或失衡放置时，该困难加剧。很多过滤器设计为避免这种定向。然而，该问题仍是常见的，因为器件不以稳定方式锚固在IVC内。除了血块之外，持续不断血流会使IVC内的过滤器混乱，使得重新获取变得困难。
因此，存在针对过滤器收回系统的需求，其具有改进的易用性和/或较不易受过滤器定向问题的影响。
发明内容
本文的实施方式满足该需求以及在应用于其他医疗器件应用时的其他需求。对于IVC过滤器，本主题系统可与多种过滤器架构(现有的或其他的)一起使用。因此，新的过滤器可设计用于与本主题的收回器一起使用，其中该过滤器设计需要较少的设计限制和/或折中方案。本主题系统的特征可与USPN 3,952,747、5601595、6,443,972、7,338,512及7,625,390(针对任意目的，所有这些专利以它们的整体通过参照并入本文)中任一所描述的过滤器的现有和/或修改型式关连使用，市场可得的器件包括OPTEASE、TULIP、CELECT和OPTION及其他器件。
本主题的输送和/或收回器件、包括它们的套件(组装或未组装)、使用和制造方法(包括体内或体外的组成部件的组装)都包括在本公开的范围内。它们的一些方面在上文描述，下面将结合附图呈现更加详细的讨论。
附图说明
附图图解地示意了发明的实施方式。如一般要求的或以其他方式，根据上述发明内容的更宽泛意义所描述，可以预想到除了附图中示出的那些以外的变体。
图1A和1B示意了可用于本系统内的IVC过滤器变体。
图2A-2E示意了与任意类型的可植入医疗器件的末端关连的处于各个动作阶段的输送和/或收回系统。
图3A-3F详述了用于构造本主题收回系统的预型件的制造中的步骤。
图4A示意了用于将预型件转化为最终成形器件的第一工具方法；图4B示出了使用中的这种工具；
图5A示意了用于将预型件转化为最终成形器件的第二工具方法；图5B示出了使用中的这种工具；
图6示意了在热定型后的已转化的预型件(即，本主题器件的最终成形的漏斗段)。
具体实施方式
下文描述了各个例证性实施方式。在非限制意义上参照这些示例，同时应该指出的是，提供这些示例以示意所述器件、系统和方法的更宽泛的可应用方面。在不偏离各个实施方式的真实精神和范围的情况下，可以对这些实施方式做出各种变化并且可以替换等效例。另外，可以做出许多变化以使特定情形、材料、物质组成、过程、(一个或多个)过程动作或(一个或多个)步骤适应本发明的(一个或多个)目的、精神和范围。所有这些修改都旨在处于本文所做出的权利要求书的范围内。
图1A示出了TULIP(Cook Medical，Inc.)的暂时性IVC过滤器10，其具有钩12末端接口用于收回。如图1B所示，针对IVC过滤器20，钩可以修改或取代瘤状接口22。瘤(自身)可包括延伸部26上从毂28激光成形的或焊接成形的凸起或凸块24。可替代地，如图2A-2E所示，(该)过滤器收回接口22可包括安装(例如，通过模锻、熔接、胶粘等)在延伸部26上的带24’(例如，Pt标记带)。然而，产生了放大，其与系统其他部分的交互将在下面附图中变得清楚。
因此，图2A提供了本主题系统100的概观。这里，示出了由编织物材料32制成的漏斗捕获器结构30。它提供了针对细长轴杆34的柔性远侧延伸部。该轴杆接收在细长套筒50内(其可以是市场可得的导管或总体系统100的定制部件)并可包括远侧不透射线的标记带52。
编织物可包括镍钛诺(其优选地在体温时是超弹性的)、CoCr、不锈钢或其他生物兼容材料。有利的是编织材料包括以一上一下(1-over-1，或表示1对1)、二上二下(2-over-2，或表示2对2)或其他形式的在72和192之间的丝线“端(ends，或表示经纱)”。利用(超弹性)镍钛诺，导丝的直径有利地处于约0.001和约0.003英寸之间。在该情形中，提供柔软且相对“平滑”的基体表面，由此构造所示出和描述的柔性漏斗捕获器架构。该表面的价值是在其防损伤方面和/或帮助引导IVC过滤器接口就位以用于获取的能力，即使它是侧斜定向的。然而，编织物中的其他导丝尺寸和/或端计数或其他构造选择也是可能的。
为了进一步辅助重新获取，可选择地是漏斗捕获器结构30是可引导的。如图2A中的箭头所指示，它的制造材料能够被热定形或以其它方式加以构造，以提供在角度方向上的偏压。部署的角度通过中芯构件或封闭器(未示出)的相对位置或者通过套筒或导管护套是可选择的或完全校直的，如进一步所述。通过旋转器件可实现进一步定位，如进一步示意。
用于选择器件的本主题的漏斗捕获器部的角度定向的其他器件连接选择也是可能的。任意多个可操纵或可引导导管类型技术(依靠牵引导丝或其他方式)能够结合在轴杆34中用于该目的。示例包括USPN 4,723,936、4,960,411、6,251,092及8,273,073中描述的机构，每者都以它们的整体通过引用并入本文，以用于该描述。
在任意情形中，图2B以截面形式示出了经编织的多丝器件的有利构造。这里，内侧和外侧编织物层32/32’使用常规技术(例如，在熔炉、盐罐内等)热定形为漏斗形状，其中编织物导丝中的远侧弯曲36形成具有(较)大的远侧开口的外缘40，并汇合在内侧弯曲38处，形成具有(较)小的更近侧开口的内缘42。换句话说，用于构造漏斗状捕获器的编织物在远侧开口处折回(例如，在折翼(flap)46)以提供更近侧开口。
该“漏斗捕获器”可大致是所示出的平截-锥形的形状或以其他方式构造。通过外侧锥形形状(即，截面为三角形)，该结构对任意需要或期望的组织分离是高度支持的，其需要发生以释放所安置的过滤器。另外，该形状提供柔性“腰”段48，用于上面提到的(一个或多个)可引导特征。然而，在不偏离所要求的发明主题或变体的情况下，该器件可以沿其侧面是朝外弓形的或以其他方式进行构造。
重要的是，远侧缘开口40大于更近侧缘开口42，以在将(一个或多个)过滤器啮合特征或扩大部24/24’引导进入袋44内时如所示意地进行操作，在使套筒50前进时，它在袋44中被获取并随后锁定，如图2D和2E所示。
如所示，这样的袋44形成在编织物32壁和弯曲38端之间，其可选地作为与瘤/凸块24/24’的可选肩部38’的毗邻特征。为了确保获取，套筒50可以在撤回到单独导管之前如图2E所示地完全前进到捕获器30上。换言之，将套筒50在漏斗段30上前进“闭合了捕获器”并牢固地获取待收回的植入物。另外，套筒可以是导管，并且轴杆34继续撤回直至植入物(左方)也被牵拉到其中。医生通过标记特征24/24’和52和/或可便利提供的其他特征而荧光地观察任意或所有这些活动。
特别地，在通过更加典型的钩端12获取过滤器10时，可同样地使用系统100。然而，钩的其他块/横向延伸部会不可避免地使用比图2A-2E所描绘的相对更大的套筒或导管50。
在各个系统架构中，导管/推进器轴杆和/或套筒可包括简单挤压(例如，PTFE、FEP、PEEK、PI等)或可使用传统导管构造技术来构造并且包括线性的、编织物支撑和外套(未示出)、金属海波管(hypotube)等。此外，可以使用传统激光器切割和电抛光技术来构造过滤器框架和/或用其它方式加以构造。在旨在用于通过引导/输送导管而没有合为一体的护套来追踪的实施方式中，可以利用加载护套。有利地，任意这种加载护套是可裂开的。结合本发明实施方式还可以利用其它典型的经皮进入器械(诸如导丝，等)、阀及其他硬件。
漏斗捕获器结构30可以制造为分组件并附接至导管/推进器轴杆。图3A-3F详述了用于构造最终器件的漏斗捕获器部的预型件的制造中的可选步骤。
在图3A中，提供了如上所述的编织物的长度或段200。这样的编织物在张力下在芯轴上有利地热定型，该编织物形成在该芯轴上。如现已期满的USPN 6,447,531所描述的，该方法增强了编织物稳定性，用于在器件的进一步定型中的随后器件成形。
在图3B中(截面图)，编织段示出为对折(doubled)在一段海波管300上。这可以在编织物的内层204从中馈通后，通过将现在编织物200的外层202翻转到海波管上而完成。可替代地，内层可以在外层置于海波管上后馈入并通过海波管。在任意情形中，编织物导丝在海波管的远侧端处以折叠210弯曲。接下来，编织物固定至海波管以热定型(例如，针对镍钛诺编织物在520℃下5分钟)。编织物可通过韧性导丝缠绕或裹住，或者外部构件可用以相对于海波管保持编织物以用于热定型。
在热定型后，如图3C中所示，移除海波管，仅留下以形式为层202和204的编织物200。如图3D中所示，编织物层可以切边(例如，通过剪刀)为相同长度。在图3D中(另一截面图)，插入带302以毗邻编织物中的折叠。
与海波管300一样，带302优选地包括最小厚度的坚实材料。在每个情形中，该结构与在编织物导丝中形成弯曲有关。如所述，较薄材料将产生编织物的更紧半径折叠(或编织物导丝的弯曲)。有利地，每个海波管300和带302包括超弹性镍钛诺，只要它们处于期望的壁厚度(即，从约0.001至约0.002英寸)，该部件坚硬且不易变形和/或撕裂，如同相似构造的(其他可用)不锈钢、铂、或铜片。
一旦通过带302制备，则折叠的编织物和带能够接收在杆310的袋或槽312内或另一管或海波管的末端内。袋可为编织物提供轻压配合。另外，带和编织物中间构造可通过胶剂(例如，LOCTITE 4014)固定在槽310内。
然后，两编织物层202/204都在杆上转动或翻转并固定于此(例如，通过如上述的缠绕)，如图3E中所示。如此固定，编织物200包括第二折叠212，如图3E中所示(截面视图)。在热定型时(例如，再次如上述)，(一个或多个)折叠在形状上设置或固定。然后，移除杆和带，提供最终的预型件220，如图3F所示。
鉴于其简化的工具，用于形成弯曲210/212的该方法是有利的，此外，用于该方法的工具(即，带和/或管)能够在厚度上最小化以提供编织物中可能的最紧的折叠。正是这样，能够实现如最终形成的压缩医疗器件的最小直径。
关于该成形(即，从预型件转换为最终器件构造)，图4A示意了可以如此使用的第一组工具320。工具组320包括内部构件或芯轴330和具有空腔342外部构件340。这些在图4B中(截面视图)关于预型件220的使用中示出。通过编织物如此定位并固定在杆322上(例如，如上述的栓系(tied-down))，可选地结合固定螺钉324，编织物在工具构造内加热以限定最终漏斗捕获器器件形状(例如，结合图6所详细说明的)。
特别地，由于工具的热质量，最终热定型周期会占用相比先前周期更长的周期。正是这样，期望的是在温度下热处理约10分钟。此外，期望的是在惰性气体中热定型以最小化氧化产物。这对于先前的热定型活动也如此适用。
针对具体的工具特征，芯轴330包括锥段332/332’和肩段334/334’。同时，这些段提供了针对最终器件角度构造和形成的引导。杆间隙孔(hold)336和螺纹固定螺钉孔338也可设置在芯轴330中。外部构件340包括前述的袋342以及各自的可选固定螺钉和杆间隙孔344和346。
外部构件340无需用于定形。然而，其在成形过程中的使用/内含物会由于其应用的进一步约束而有利地减少部件与部件的可变性。
图5A示意了用于将预型件220转换为最终成形器件的第二工具方法。这里，提供两部件芯轴350。它包括锥形件360，具有成角度嵌入件或袋362，其通过在缘或唇364处约束编织物的折翼和折叠212来提供可能的优势。工具350的毗邻件370可用于进一步约束编织物。它包括与嵌入件362互补的锥段372，并还可包括肩段374以在热定型期间进一步约束或压缩编织物。与芯轴330提供的构造相比，折叠和折翼区域内的更多约束一起(或仅使用锥形件360)可在诸如图5B(截面视图)中所示的成形过程中避免使用类似构件340的外部构件的需要或优点。但是，外部构件(类似图4A中所示的构件340)可用于与工具350结合。
通常，前述成形方法是其中提供大致柱形状并包括内部折叠“折翼”段的热定型(可能多阶段热定型)预型件的方法。正是这样，预型件在其完全压缩状态类似本主题器件用于导管跟踪。然后，扩展(例如，以锥形形状)预型件至期望的“工作”构造并因此热定型。
另一成形和工具方法可在定型过程中使用薄壁锥形带(未示出)。这些可用于直接成形或形成捕获器件30的锥形和折翼段。该工具可通过向下“旋转”薄壁柱形材料至期望锥形形状并然后修剪最终件至一定长度来构造。然而，内部工具(正是这样)的使用会限制热定型后编织物层处于同位的程度，进而导致各层之间的一些间隙(即，除非编织物随后使用图4A/5A所示的工具或以其他方式来形成)。
不管利用哪一种工具方法，图6示意了转换为(或另外形成的编织物)本主题漏斗捕获器架构30后的预型件。针对IVC过滤器收回，漏斗捕获器部30可具有从约5mm至约20mm的直径(D)，或更优选约10至约15mm(即，在平均尺寸人体IVC内动作的范围内的尺寸，其中这些血管报告为具有20mm的平均直径，处于13至30mm范围内)。长度(L)可处于从约10mm至约30mm的范围内。整个锥角(α)可处于约30和约90度之间。折翼46的角度(β)可处于约0和约60度之间，以及折翼长度(F)可处于约1和约10mm的长度之间。总体上，基于所指出变量(即，d、D、L、F、α和β)的选定组合，漏斗捕获器开口直径(d)可以是直径(D)的约5％和约95％之间。在该范围的低端，内部“开口”可基本闭合以使得它需要被推开以在收回期间接收植入物的(一个或多个)近侧啮合特征。在该范围的高端，折翼可位于完全沿器件的(一个或多个)外层或与其对齐。
变体
本主题的方法(包括使用和/或制造方法)可以以逻辑上可能的任意事件顺序、以及事件的任意叙述顺序来执行。医疗方法可包括与器件供应、植入物定位、重新定位、收回和/或释放相关的任意医务人员活动。
此外，在提供数值范围时，应该理解的是在该范围上限和下限之间的每个中间值以及任意其他声明的或声明范围内的中间值都包含在本发明内。此外，可以预想到的是，所描述的发明变体的任意可选特征可以独立地或结合本文所述的任意一个或多个特征来说明和要求。
尽管本发明已经(可选地结合各个特征)参照若干示例进行描述，本发明不限于关于本发明的每个变体所预想的描述或指示的那些情况。可在不偏离本发明真实精神和范围的情况下，针对所述的本发明做出各种变化以及以等效物(出于一些简洁的目的，无论本文叙述与否)可以加以替换。
针对单数项的参照包括具有多个相同项存在的可能性的情况。更加具体而言，如本文以及在所附权利要求书中所使用的，单数形式“一”、“一个”、“所述”和“该”包括复数指示物，除非另有具体声明，换言之，冠词的使用考虑到上文描述以及所附权利要求书中的“至少一个”主题项的情况。还应该指出的是，权利要求书可以设计以排除任意可选要素。正是这样，该声明旨在用作为针对使用这些排他性术语(如结合权利要求要素的叙述的“仅”、“只”等或使用“否定”限制的前置基础。
在不使用这些排他性术语时，权利要求书中的术语“包括”应当考虑包括任意另外要素，而不管权利要求书中是否枚举了给定数量的要素，或者特征的加入能够被认为是转换权利要求书中说明的要素的性质。除非本文特定地限定，在保持权利要求书有效的同时，本文所使用的所有技术和科学术语将给出尽可能宽泛的通常理解意义。因此，不同发明实施方式或本文所描述的各方面的宽度不应该限定为所提供的示例和/或主题说明书，而仅由公开的权利要求语言的范围所限制。

Claims (8)

1.一种用于血管医疗器件输送或收回的装置，所述装置包括：
细长套筒；以及
接收在所述套筒内的细长轴杆，所述轴杆具有柔性的远侧延伸部，所述远侧延伸部具有向内折回的部分，所述向内折回的部分开始于远侧开口并终止于近侧开口，以形成漏斗；
其中，所述近侧开口的尺寸设定为接收经过所述近侧开口的所述医疗器件的扩大端并使其穿过所述近侧开口，并且
其中，所述装置适于使得当所述套筒在所述远侧延伸部上前进时使所述医疗器件的所述扩大端固定在所述远侧延伸部内的袋中。
2.如权利要求1所述的装置，其中所述远侧延伸部包括具有在72和192之间的端计数的热定型镍钛诺编织物。
3.如权利要求2所述的装置，其中所述轴杆包括镍钛诺编织物。
4.如权利要求1所述的装置，其中所述套筒包括导管。
5.如权利要求1所述的装置，其中所述远侧延伸部在角度定向上是能够选择的。
6.如权利要求1所述的装置，其中所述扩大端从带和钩中选择。
7.如权利要求1所述的装置，其中所述远侧延伸部具有外侧锥形。
8.一种下腔静脉过滤器系统，其包括如权利要求1所述的装置，其中所述医疗器件是下腔静脉过滤器。
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