CN112716652A - 具有可释放的捕获特征的ivc过滤器回收系统 - Google Patents
具有可释放的捕获特征的ivc过滤器回收系统 Download PDFInfo
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Abstract
本发明公开了具有可释放的捕获特征的IVC过滤器回收系统。由编织物制成的漏斗捕捉器型装置或系统用于捕获和回收或者替代地捕获和随后释放下腔静脉(IVC)过滤器或其他医疗装置。构思出了输送和/或回收装置、其中包括它们的套件、使用方法和制造方法。
Description
本发明为分案申请,其母案的申请号为201580067678 .4,申请日为2015年12月10日且发明名称为“具有可释放的捕获特征的IVC过滤器回收系统”。
技术领域
本文所描述的实施例涉及血管内临时下腔静脉(IVC)过滤器或者其他植入物的回收装置或系统和方法。
背景技术
临时IVC过滤器被放置得非常像永久过滤器,但是被设计成使得它们可以在单独的血管内手术中、一般从股静脉或颈内静脉途径回收。大多数当前可用的临时过滤器包括钩状特征,可以利用该钩状特征在导管或护套内捕捉和接收它们,以便通过采用鹅颈圈套器(gooseneck snare)或多圈圈套器(multi-loop snare)来移除。
虽然回收原则上是简单的过程,但在利用圈套器的圈来捕捉过滤器的钩时经常遇到困难。当过滤器倾斜或放置不正常时,这种困难会加剧。设计了若干过滤器来避免这样的定向。然而,该问题仍然是常见的,这是因为装置未以稳定的方式锚固到IVC中。除了血凝块之外,持续的血流可能使IVC内的过滤器失去方向,从而使重新捕获变得困难。因此,仍然需要过滤器的改进的回收系统。
发明内容
本文描述的示例性实施例满足了这一点和/或其他需求,特别是在解决过滤器检索期间的任何复杂性经验方面。具体地,主题装置或系统包括如果需要,允许捕获或回收和随后释放下腔静脉(IVC)过滤器或其他医疗装置的特征。换句话说,当需要所谓的“应急措施”,以避免其他并发症时,主题装置允许IVC滤波器捕获的反转。
在使用过滤器的组织向内生长量大于预期的情况下,释放捕获或钩挂的IVC过滤器的能力是可取的。在过滤器回收过程中希望(在某种意义上)反向过程的其他原因可以由本领域技术人员表达。
在主题系统中,反转选择在设计操作方面既具有比喻性和字面性。即,提供了用于重新配置和反转包含在回收装置中的折片的特征,否则其旨在捕获IVC过滤器。在反转状态下,回收装置中的挡板被配置为保持过滤器。当折片反转(即向外或向外转动)时,释放或允许释放过滤器。
在一个实施例中,在设计中结合有推动线,以便于避免另外反转的折片构型。该线可以包括并排配置的一对丝线,一对(或多个)丝线被扭曲并设置成形成电线电缆,一部分导管结构,或以其它方式配置。
在另一个实施例中,单独的活塞或推动元件可以通过取出装置的腔(可选地是中心腔)展开,然后被进一步扩大并进一步实现折片外翻。在该示例中,当需要使用时,活塞装置可以分开设置并通过回收装置中的腔进行跟踪。替代性地,可以如套件或组合一样将活塞结合或容纳在回收装置中。
然而,构造的主题的输送装置或回收装置,其中包括它们的套件(有和没有组装)、使用和制造的方法(包括体内或体外组成部件的组装)全部都包括在本公开的范围内。以上描述了一些方面,更详细的讨论结合下面的附图给出。
在查阅下面的附图和详细描述时,本文所描述的主题的其他系统、装置、方法、特征和优点对于本领域技术人员将会或将变得显而易见。所有此类附加的系统、装置、方法、特征和优点都意在包括在本说明书内,包括在本文所描述的主题的范围内,并由所附权利要求来保护。除非权利要求中的这些特征有明确说明,否则示例性实施例的特征决不应被解释为限制所附权利要求。
附图说明
通过研究附图,可以清楚关于其结构和操作二者的本文所阐述的主题的细节,附图中相同的附图标记表示相同的部分。附图中的部件不一定按比例绘制,而是将重点放在说明主题的原理上。此外,所有图示都旨在传达概念,其中,相对尺寸、形状和其他详细属性可以被示意性地而非确实地或精确地图示。
图1A和1B是可以在本系统中使用的IVC过滤器变型的示例性实施例的图片。
图2A-2C是描绘包括可逆过滤器捕获特征的第一回收系统的示例性实施例的侧视图。
图3A和3B是描绘包括用于过滤器捕获特征反转的活塞的回收系统的另一示例性实施例的侧剖视图。
具体实施方式
在详细描述本主题之前,应当理解的是,本公开不限于所描述的特定示例性实施例,因此当然可以变化。还应当理解的是,本文所使用的术语仅用于描述特定实施例的目的,并不意在是限制性的,这是因为本公开的范围将仅由所附权利要求限制。
关于本文提供的任何实施例所描述的所有特征、元件、部件、功能和步骤意在可与来自任何其他实施例的特征、元件、部件、功能和步骤自由地组合,并且可用其来替代。如果仅关于一个实施例描述特定的特征、元件、部件、功能或步骤,则应当理解,该特征、元件、部件、功能或步骤可以与本文所述的每个其他实施例一起使用,除非另有明确说明。因此,本段在任何时候作为引入权利要求的前提依据和书面支持,该权利要求将来自不同实施例的特征、元件、部件、功能和步骤组合,或者用另一个实施例的特征、元件、部件、功能和步骤来替代来自一个实施例的特征、元件、部件、功能和步骤,即使下面的描述在特定情况下没有明确地说明这样的组合或替代是可能的。对每种可能的组合和替代的明确说明过于麻烦,特别是考虑到每一个这样的组合和替代的可容许性在阅读本说明书时将容易被本领域技术人员认可。
图1A示出了GÜNTHER TULIP(Cook Medical,Inc.)的临时IVC过滤器10,其具有用于回收的钩12端接口。如图1B中所示,对于IVC过滤器20,钩可以被修改或替代为结节型(nubbin-type)接口22。结节24可以包括处于毂28的延伸部26上的激光形成或焊接形成的突起或隆起。替代性地,过滤器回收接口22可以包括安装(例如,通过模锻、焊接、胶合等)在延伸部26上的带(例如,Pt标记带)然而,产生了扩大部分,其与系统的其余部分的相互作用在下面的图中将显而易见。
图2A提供了适于释放或可逆地捕获医疗装置(例如过滤器10或20)的回收系统100的远端的剖视图。系统100包括具有由编织材料制成的漏斗捕捉器结构形式的远侧延伸部40的轴30。在患者的脉管系统中使用时,轴被容纳在细长的套筒60内(其可以是市售的导管或整个系统100的定制部分)。
在各种系统架构中,导管或推动器轴和/或套筒30(和详细说明如下的活塞)可以包括简单的挤压部(例如,PTFE、FEP、PEEK、PI等),或者可以使用常规的导管构造技术来构造,并且包括衬里、编织支撑件和外套、金属海波管(hypotube)等。过滤器10或20的框架可以使用常规的激光切割和电解抛光技术来构造和/或以其他方式来构造。在意在用于通过没有结合护套的引导/输送导管进行跟踪的实施例中,可以采用加载护套。有利地,任何这种加载护套都是可分开的。在实施例中也可以采用其他典型的经皮进入器械(例如线材等)、阀和其他硬件。
漏斗捕捉器结构40可以制作为子组件并且附接到导管/推动器轴。国际专利申请号PCT/US14/42343和美国专利申请序列号14/569,500,其各自通过引用整体并入本文用于所有目的,详细说明制造用于构造最终装置的漏斗捕捉器部分的预成型件的可选步骤。一般而言,上述形成方法是其中设置有在形状上为基本上圆柱形并且包括内部折叠的“折片”部段的热定型(可能为多级热定型)预成型件的形成方法。因此,预成型件类似于处于其完全压缩状态用于导管跟踪的主题装置。然后,预成型件被扩展(例如,呈锥形形状)到期望的“加工”直径并相应地热定型。它可以被热定型成锥形并准备好安装,或者它可以被热定型成锥形并通过安装到导管主体30而变形成锥形。
可选地制成回收系统延伸部40的编织物可以包含镍钛诺(优选在体温下是超弹性的)、CoCr、不锈钢或另一生物相容性材料。编织物有利地包含按照一上一下(或1对1,1-over-1)、两上两下(或2对2,2-over-2)或其他五月柱编织样式(maypole pattern)的在72个和288个之间(更典型地,在96个或144个和192个之间)的丝线“端”。对于(超弹性的)镍钛诺,线材在直径上有利地在大约0.001英寸和大约0.003英寸之间。在这种情况下,提供柔顺和相对“平滑”的基质表面,由此构建所示和所述的柔性漏斗捕捉器架构。这种表面的价值在于它的无创伤方面和/或帮助引导IVC过滤器的接口就位以便捕获的能力,即使它偏斜(off-angle)定向。为了进一步帮助重新捕获,漏斗捕捉器结构可以是可选择地可定向的(directable)。
编织物也可以包括所谓的“轴向”丝线。这些可以被用于在最终形成的装置中提高柱强度(column strength)。轴向丝线可以在它形成时按照一种/所述五月柱编织样式来结合,或者后来手动添加。替代性地,(并且如图2A中所示),漏斗捕捉器结构40可以包括在美国临时专利申请序列号62/091,433中进一步描述的插入的支撑构件,其全部内容通过引用并入本文用于所有目的。
所谓的“漏斗捕捉器”结构或延伸部40可以如图所示或以其它方式构成的形状通常为截头锥形。利用外锥形形状(即,截面中的三角形形状),该结构对于可能需要发生以释放安置的过滤器的任何必要或期望的组织辨别力(tissue discretion)是高度支持的。然而,装置可以沿其侧面向外弯曲或其他方式按来构造。
图2A示出了进一步的结构选项和细节。这里,内编织层和外编织层42/42'使用在漏斗形状中的常规技术(例如,在炉子、盐锅等中)来热定型,其中,编织线中的远侧弯曲部44形成具有大(较大)的远侧开口的外缘46、48 并且在内弯曲部50处的会聚形成具有小(较小)的较近侧开口54的内缘52。换句话说,用于构造漏斗形捕捉器的编织物在远侧开口处折回(例如,以折片56),以提供较近侧的开口。
重要的是,远侧边缘开口48大于较近的边缘开口54,以操作以将过滤器接合特征或放大12/24引导到靠近和/或径向相邻的折片56的袋58中, 并且随后锁定在前进的套筒60上。以这种方式初始捕获过滤器10如图2B所示。
为了帮助确保捕获,在退回到单独的导管之前,如中所示,套筒60可以前进完全超过捕捉器部段40。换言之,在漏斗部段40之上前进的套筒60(无论是系统还是设备一体式套管或原位导管)“关闭捕捉器”并且牢固地捕获待回收的植入物。否则,可以撤回轴30,直到植入物被拉入最初用于引入系统100的进入导管。任何或所有这样的活动可以由医师通过结合在系统100中的标记特征透视地可视化。
值得注意的是,当用更多的凸块或结节24终端接口捕获过滤器20时,系统100可以被相同地使用。在这种情况下,下面详述的捕获反转特征可能不需要用于释放植入物末端。然而,通过这样的特征,提供了一种解决方案来处理更广泛的过滤器,并且一旦实现,就需要释放捕获。
关于主题捕获释放或反转特征,在图2A-2C中所示的实施例中,这些与内轴62和推“线”64连接。在所示的构造中(并且完全标记有图2B中的标注),线丝环绕在或通过形成由带68(例如卷曲的PT标记带)固定的“U”形66的边缘52的一部分。如图2C所示,当导线64前进时,固定到编织物上,延伸部40的翼片部分56可以从倒置构型移动到直立构型。这释放了过滤器10的钩12。
排出或释放钩12的动作显然是显而易见的。可能伴随着抽出轴30,使得钩可以从反转的折片滑出。而且,当该装置处于图2B所示的结构时,折片56可以在其内表面上并入涂层70(例如,TICOFLEX聚氨酯涂层),以便固定该编织物以防止钩缠结或滞留。
图3A和3B中的系统100'类似于上述,除了更复杂的推动器200代替推进线64。该推动器200可以被接收在导管主体30的腔72内(如线64)。
如图所示,推动器200可被视为或被称为“活塞”,其功能如图所示。即,推动器200在其在系统的漏斗捕捉器延伸部30中扩展之后在腔72内前进,并且用于向外推动折片56以实现植入物接合特征释放。在医疗过程期间,在系统100'的引入期间,推动器可以驻留在腔72中。替代性地,如果医师确定捕获的植入物10的释放在某种程度上是可取的,则它可以是单独包装的并且通过腔72“按需”插入和跟踪包装。
在任何情况下,推动器200包括套筒202和可扩展的远侧部段204。可扩展的远侧部段可以包括如图所示的编织物。用于从被推出并被压缩,拉入扩展的编织致动的拉线206可以包括在套筒内。否则,编织物(或诸如管切割镍钛诺支架结构的其它材料)可以在放大配置中热定型,以便一旦离开腔自动扩展并连接到远端。
在图3A和3B所示的变型中(即,使用基于编织物的部段204),编织物的远端可固定在远端Pt标记带208内的线206。可以在可扩张部分的近端处设置另一个标记带210,将可编织物的近端固定到编织端到套筒或轴202。因此,当拉丝206被致动时,即使可扩展部分的材料本身不是透视可见的,也可以检测部段204的扩展和/或收缩(即,通过观察标记的致动)。
变型。
主题方法,包括使用和/或制造的方法,可以按照逻辑上可能的事件的任何顺序以及任何所列举的事件顺序来执行。医疗方法可以包括与设备提供、植入物定位、重新定位、回收和/或释放相关联的医院工作人员的任何活动。
此外,在提供值的范围的情况下,应当理解的是,在该范围的上限和下限之间的每个中间值以及处于所述范围中的任何其他陈述的值或中间值也包含在本公开内。此外,还预期所描述的实施例的任何可选特征可被独立地或与本文所述的特征中的任何一个或多个结合地来阐述和要求保护。
对单数项目的引用包括存在多个相同项目的可能性。更具体而言,如本文和所附权利要求中所用的,单数形式“一”、“一个”、“所述”以及“该”包括复数指示物,除非另有明确说明。换言之,使用这些冠词允许上述描述以及下面的权利要求中的主题项目中的“至少一个”。还要注意的是,权利要求可被撰写成排除任何可选的元件。因此,该陈述意在作为结合权利要求元件的陈述来使用诸如“单独”、“仅”之类的排他性术语或使用“否定”限制的前提基础。
虽然实施例易于进行各种修改和替代形式,但是其具体示例已经在附图中示出,并且在此进行详细描述。然而,应当理解,这些实施例不限于所公开的特定形式,而是相反,这些实施例将覆盖落入本公开精神内的所有修改、等同物和替代方案。此外,实施例的任何特征、功能、步骤或元件可以被引用到权利要求中或添加到权利要求中,以及通过不在该范围内的特征、功能、步骤或元件定义权利要求范围的负面限制。
Claims (12)
1.一种用于血管医疗装置回收的设备,所述设备包括:
细长的套筒;以及
细长的轴,其接收在所述细长的套筒内,所述轴具有包括编织物的柔性的远侧延伸部,所述远侧延伸部在远侧开口处向内折回,以形成折片和近侧开口,
其中,所述近侧开口尺寸设定成接收所述医疗装置的端接口并使之通过所述近侧开口,
其中,所述设备适于使得当所述细长的套筒前进超过所述远侧延伸部时,或者当所述远侧延伸部撤回到所述细长的套筒内时,所述医疗装置的端接口能够被固定在由所述远侧延伸部的所述折片和未折回部分限定的袋中,
其中,所述设备适于使所述折片从向内定位反转成向外定位,以便释放所述医疗装置的端接口,并且
其中,所述医疗装置的端接口包括隆起。
2.如权利要求1所述的设备,其特征在于,所述远侧延伸部包括编织物。
3.如权利要求2所述的设备,其特征在于,所述编织物包括镍钛诺,其具有72个至288个之间的端计数,并且包含轴向纤维。
4.如权利要求2所述的设备,其特征在于,所述折片的至少内表面被涂层涂覆,以保护所述编织物防止所述医疗装置的端接口的侵入。
5.如权利要求4所述的设备,其特征在于,涂层包括聚氨酯。
6.如权利要求1所述的设备,其特征在于,所述细长的套筒包括导管。
7.如权利要求1所述的设备,其特征在于,适于反转所述折片的是接收在所述轴的腔内的推动器。
8.如权利要求7所述的设备,其特征在于,所述推动器包括附接到折回的延伸部的线。
9.如权利要求7所述的设备,其特征在于,所述推动器包括活塞,所述活塞包括套筒和可扩展的远侧部段。
10.如权利要求9所述的设备,其特征在于,所述活塞还包括牵引线,所述牵引线接收在所述活塞的所述套筒内,并且连接在远端处用于扩展所述可扩展的远侧部段。
11.如权利要求10所述的设备,其特征在于,所述可扩展的远侧部段包括编织物。
12.一种包括血管医疗装置的系统,所述系统还包括如权利要求1至11中任一项所述的用于血管医疗装置回收的设备。
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2015
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EP3229728B1 (en) | 2022-11-02 |
US20160166370A1 (en) | 2016-06-16 |
EP3229728A1 (en) | 2017-10-18 |
CN107405189B (zh) | 2021-01-22 |
JP2020116412A (ja) | 2020-08-06 |
US10278804B2 (en) | 2019-05-07 |
JP6688800B2 (ja) | 2020-04-28 |
JP2017536927A (ja) | 2017-12-14 |
EP3229728A4 (en) | 2018-07-11 |
US20190262117A1 (en) | 2019-08-29 |
CN107405189A (zh) | 2017-11-28 |
JP7012114B2 (ja) | 2022-01-27 |
WO2016094708A1 (en) | 2016-06-16 |
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