CN103945775B - 具有从闭塞面的周向边缘延伸的锚定件的闭塞装置 - Google Patents

具有从闭塞面的周向边缘延伸的锚定件的闭塞装置 Download PDF

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CN103945775B
CN103945775B CN201280056563.1A CN201280056563A CN103945775B CN 103945775 B CN103945775 B CN 103945775B CN 201280056563 A CN201280056563 A CN 201280056563A CN 103945775 B CN103945775 B CN 103945775B
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C·C·拉森
S·J·马斯特斯
E·E·肖
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Abstract

闭塞装置(100)包括框架元件(102)，该框架元件具有远端(112)和近端(110)、输送构造和展开构造。该闭塞装置还包括具有周向边缘(114)的闭塞面(106)，其中闭塞面朝向框架元件的近端定位。该闭塞装置还包括至少一个锚定件(50)，该至少一个锚定件定位在闭塞面的周向边缘处，其中至少一个锚定件以锐角延伸到闭塞面的周向边缘。

Description

具有从闭塞面的周向边缘延伸的锚定件的闭塞装置
相关申请的交叉引用
本申请要求了2011年9月6日提交的美国临时专利申请61/535,830的优先权。
技术领域
本发明涉及例如用于患者体内的闭塞结构或管道、特别是人体心脏内的心耳的闭塞装置以及制成和使用这些装置的方法，这包括输送、展开和收回或重新定位这些装置。文中所述装置能经皮或以血管内的方式来进行输送。
背景技术
血栓中风在美国是第三大死亡原因，并且是成人残疾的最常见原因。每年单单在美国就有超过780000次中风。在这些中风中，约110000是出血性的，而670000是缺血性的(由于血管狭窄或血管阻塞)。心源的缺血性中风的最常见的诱因是由于心房纤颤的血栓栓塞(thromboemboli)。六分之一的中风(每年约130000)归因于心房纤颤。心房纤颤是最常见的心律失常；它造成使心输出量下降并导致血管系统中的不规则的和湍流的血流的快速和混乱的心跳。全世界有超过8百万人心房纤颤，每年报道的新案例超过约80万。与年龄匹配的健康者对照，心房纤颤与风险更高的中风有关。具有心房纤颤的患者通常的生活质量明显下降，这部分地是由于害怕中风以及减少该风险所需的药物养生。
当患者从心房纤颤发展为心房血栓时，90％以上凝块出现在心脏的左心耳内或源自左心耳。左心耳是看起来像小拇指或风向袋的闭合内腔；它在二尖瓣与左肺静脉的根部之间连接到左心房的前外侧壁。在正常的心脏循环期间，左心耳与左心房一起收缩，由此避免血液阻滞。然而，在心房纤颤的情况下，左心耳由于紊乱的电信号而经常无法以任何活力来收缩。由此，血栓症易于在左心耳内的阻滞血液内形成。
用于防止心房纤颤患者中风的药物治疗，诸如口服或全身应用华法令阻凝剂由于严重的副作用以及缺乏患者顺从性而经常一般是不适用的。已采用侵入性外科或胸腔镜技术来消去左心耳；然而，许多患者由于受损状况或之前的心脏手术而不是这种手术的合适人选。此外，这些外科手术的察觉到的风险经常超出可能的获益。
用于防止心房纤颤患者中风的、试图使左心耳闭塞的许多目前可购得的装置采用了刚性的圆筒形支承框架，该支承框架具有刺穿组织的固定构件，这些固定构件与心耳内的组织本身接合。左心耳的缺口(口部)的几何形状和尺寸变化。借助预先假定为圆形口部的刚性框架来密封左心耳在防止血栓栓塞进入系统循环方面不太有效。
对一些目前装置的另一担心是这些装置所用的过滤型隔膜。这些隔膜是大孔的，并且通常需要大段时间来中止血液流过隔膜。这种隔膜会花上几小时到几周来基本上闭塞左心耳。血栓栓塞可能会在过滤隔膜的凝块/闭塞过程进行的同时进入血流中。这些心房纤颤患者中的许多正在进行某些类型的血液稀释(抗凝血剂或抗血小板)药物治疗中，这会延长这些过滤隔膜的凝块/闭塞过程，并使患者面临中风风险。
发明内容
在第一总体方面，闭塞装置包括框架元件，该框架元件具有远端和近端、输送构造和展开构造。闭塞装置还包括具有周向边缘的闭塞面，其中，所述闭塞面朝向所述框架元件的近端定位。闭塞装置还包括定位在闭塞面的周向边缘处的至少一个锚定件，其中，至少一个锚定件以相对于闭塞面的周向边缘的锐角延伸。
在各种实施方式中，至少一个锚定件可包括组织接合构件，该组织接合构件关于装置的轴向尺寸沿近侧方向突出。至少一个锚定件可包括组织接合构件，该组织接合构件关于装置的轴向尺寸沿远侧方向突出。至少一个锚定件可包括从框架元件的在锚定件附近的一部分切向延伸的组织接合构件。至少一个锚定件可基本上位于由周向边缘限定的平面内。闭塞面可具有凹入定向。闭塞面可具有凸出定向。闭塞面可具有大致平坦定向。多个锚定件可设置在周向边缘上。框架还包括渐缩区域。闭塞装置还可包括构造成抑制血液通过的隔膜，其中，该隔膜覆盖框架的至少一部分。隔膜可包括含氟聚合物。隔膜可包括聚四氟乙烯。隔膜可包括膨胀型聚四氟乙烯。框架可包括多个线材。多个线材可包括镍钛诺。框架可包括圆筒形区域，该圆筒形区域以大致远侧方向从闭塞面延伸第一距离，而渐缩区域可从圆筒形区域的远端延伸到框架的远端。闭塞装置还可包括设置在圆筒形区域和渐缩区域的接合部附近的一个或多个锚定件。框架元件包括瓣状物形状和所述瓣状物形状的顶点，且瓣状物形状的顶点包括框架元件内的弯部。至少一个锚定件可位于瓣状物形状的顶点处。至少一个锚定件包括第一箍套和第二箍套，其中，该框架元件穿过第一箍套和第二箍套中的每个，且第一箍套定位在顶点的第一侧，而第二箍套定位在所述顶点的与第一侧不同的第二侧。
在第二总体方面，闭塞脉管的方法包括提供闭塞装置，该闭塞装置包括(a)框架元件，该框架元件具有远端和近端、输送构造和展开构造；(b)闭塞面，该闭塞面具有周向边缘，并且朝向框架元件的近端定位；以及(c)至少一个锚定件，该至少一个锚定件定位在闭塞面的周向边缘处，其中，至少一个锚定件的至少一部分以相对于闭塞面的周向边缘的锐角延伸。该方法还包括将闭塞装置构造在输送构造下，并使闭塞装置前进到输送部位，并使闭塞装置在输送部位处展开。
在各种实施方式中，输送部位可以是左心耳。至少一个锚定件可与左心耳口部附近的组织接合。
从下面详细说明和附图中，本发明的实施例的其它优点、益处和新的特征将变得显然。在此包括随其包含的附图在内的所有文献、出版物和专利的全部内容以参见的方式纳入本文。
附图说明
图1是能用于使患者体内的孔洞、缺陷或心耳闭塞的示例闭塞装置的侧视图。
图2是图1所示闭塞装置的近端的正视图。
图3是图1所示闭塞装置的示例框架的立体图。
图4A和4B是图3所示框架的一部分的放大立体图。
图5是能用于制成图1所示闭塞装置的示例夹具的立体图。
图6是具有图3所示的框架线材的、图5所示夹具的立体图。
图7是具有以缠绕图案示出的图6的线材的、图5所示夹具的立体图。
图8A、8B和8C是具有图6所示线材的图5所示夹具的立体图，这些线材缠绕以形成图3所示框架的各部分。
图9是图3所示框架的一部分的立体图。
图10A和10B是图3所示框架在与中心销接合时并且在纵向扩张之前的立体图。
图11A和11B是图3所示框架在与热固芯轴接合时并且在热处理之前的立体图。
图12A、12B和12C是能用于设定图3所示框架的热固工具的立体图。
图13是图3所示框架在与图11A和11B的热固芯轴接合时并且在热处理之后的立体图。
图14A和14B是示例热固芯轴的视图。
各附图中的相同附图标记和标示表示相同的元件。
具体实施方式
文中讨论的装置和技术涉及能用于闭塞包括心脏在内的患者体内的孔洞、缺陷或心耳的闭塞装置以及制成和使用这些装置的方法。装置的一些实施方式能用于非限制性地闭塞右心耳或左心耳、瘘管、动脉瘤和开放性动脉导管。在一些实施例中，闭塞装置提供一种框架，该框架适当地或者充分地柔顺以顺应于多种开口几何形状和尺寸。文中所述装置的各实施方式可在初始展开时和稍后某个时间容易地加载到导管或套管上，以从人体内的展开位置重新定位或移除该装置。
尽管心房纤颤会造成源自左心耳(LAA)的血液凝块且文中所示的闭塞装置将参照用于左心耳来进行描述，但文中所述的装置也可用于人体的其它区域。装置的一些实施例能例如用于右心耳。一般来说，装置的各实施方式可用于横放在包括脉管系统内的孔在内的、人体的任何合适的孔上，在这些孔处需要防止血块逸出或者抑制或大幅减少血流。
特别是，闭塞装置的一些实施例能构造成闭塞左心耳。文中所述装置的各实施方式可用于顺应于多种左心耳口部的解剖体并能有效地闭塞左心耳、能证实稳固和牢固的锚定能够使由于锚定造成的创伤和出血的风险减小，并且能快速中止血液流经这些装置所包含的闭塞隔膜。闭塞装置可包括如下框架，该框架使得牢固又稳固地锚定到左心耳组织，由此使得由于刺穿造成的临床后遗症大幅减少，或者不会创伤性地刺穿左心耳组织。如下面将更详细所述，不同类型的锚定特征可用于文中公开的装置，并且锚定特征可位于装置的不同区域处或与不同区域相关联。
闭塞装置的实施例包括的隔膜构造成基本上或完全抑制血液流经该隔膜。在一些实施例中，闭塞装置可包括如下隔膜，该隔膜构造成引起快速组织内生长，并立即闭塞血液通过该隔膜。
在一些实施例中，闭塞装置包括闭塞面，该闭塞面至少部分地被隔膜和定位在闭塞面的周向边缘上的一个或多个锚定件所覆盖。在一些实施例中，一个或多个锚定件可定位到闭塞装置的不在闭塞面的周向边缘上的若干部分上。
图1和2示出示例闭塞装置100的实施例，该闭塞装置可用于闭塞患者体内的诸如左心耳的结构或管道。闭塞装置100包括近侧孔眼110、远侧孔眼112、闭塞面106、从闭塞面106沿远侧方向延伸的大致圆筒形区域107、从圆筒形区域107向装置的远端延伸的渐缩区域108以及覆盖闭塞装置100的框架102(参见图3)的隔膜104。腔体可延伸通过孔眼110和112，并通过装置100的长度。
闭塞面106构造成在展开构造下顺应于左心耳口部或其它生物口部的形状。例如，可在闭塞装置100展开过程中通过经由输送系统向框架102传递扭矩来改变或调节闭塞面106的直径。在图1和2的示例图中，闭塞面106具有凹入形状。然而，在其它示例中，闭塞面106可具有凸出形状或平坦或平面形状。闭塞面106的适应性可允许闭塞装置100设计尺寸的多样性，并且便于将闭塞装置100放置于左心耳口部内，左心耳口部通常为不规则形状，并且尺寸基本上随着患者不同而不同。
在总体实施例中，能从闭塞面106向远侧延伸的大致圆筒形部分107可呈任何合适的长度。由此，圆筒形区域107的长度考虑到左心耳口部变化或左心耳形状变化。例如，在一些实施例中，圆筒形区域107可具有约0.2厘米到约0.7厘米的长度，而在一些实施例中，长度为约0.5厘米。类似地，从圆筒形区域107向远侧孔眼112延伸的渐缩区域108可呈任何合适的长度。例如，在一些实施例中，渐缩区域108可具有约0.6厘米到约1.2厘米的长度，而在一些实施例中，长度为约1.0厘米。此外，渐缩区域108的轮廓可相对于装置的纵向轴线具有任何合适的坡度，以使闭塞装置100充分地固定在左心耳的内部区域内。例如，渐缩区域108可构造成顺应于左心耳的内部区域的可变锥度。接合部130可限定圆筒形区域107和渐缩区域108之间的边界。
在图1和2的示例中，孔眼110和112具有大致圆筒形形状。然而，孔眼110和112可大致呈多种形状，诸如矩形、其它多边形或不规则形状。孔眼110和112中的一个或两个可形成为与输送系统的一个或多个部件(例如，输送导管)接合，该输送系统能用于将闭塞装置100输送到患者体内的输送部位。例如，使输送导管与孔眼110和112中的一个或两个接合可允许将扭矩施加到闭塞装置100并保持在闭塞装置上。在一些实施例中，将扭矩施加到闭塞装置100可便于放置该装置，并且在一些实施例中可便于使装置的锚定件或锚定特征与输送部位处的组织接合。
装置100可包括附连到装置的框架102的若干部分的锚定件50、50a、50b、60(图4A)。参见图1、2、3、4A、4B、10A、10B和11A，它们是可采用的锚定件的示例。一些锚定件50可附连到构成闭塞装置100的闭塞面106的周向边缘114的框架部分，如图1和2中所示。闭塞面106结构方面由多线材框架102的近端构成。如上所述，在图1和2的所示示例中，闭塞面是凹入的，并且这可便于闭塞面106的周向边缘114上的锚定件50沿近侧方向或部分地沿近侧方向相对于装置的纵向尺寸突出。于是，在一些实施例中，闭塞面的周向边缘114上的锚定件50可以与闭塞面106的周向边缘114不在一个平面(因为它们向近侧突出)。沿装置的轴向定向朝近侧突出的锚定件可提供在展开之后与组织接合并且防止装置迁移的优点(例如，可防止装置离开心耳)。
在其它实施例中，闭塞面的周向边缘114上的锚定件50可以与闭塞面106的周向边缘114在一个平面内(即，位于或基本上位于由周向边缘114所限定的平面内)。例如，锚定件可从线材框架的锚定件50近侧的一部分沿切向突出。在其它实施例中，锚定件可成形为沿远侧或部分地沿远侧方向、从闭塞面106的周向边缘114突出，并且由此还可被认为与周向边缘114不在一个平面内。
相关地，对于闭塞面具有凸形轮廓或平坦轮廓的实施例来说，在各种实施方式中，定位在闭塞面的周向边缘上的锚定件50可类似地定向成相对于装置的纵向尺寸沿近侧、部分地沿近侧、沿远侧或部分地沿远侧方向突出，并且在这种情况下可被认为不在闭塞面的周向边缘平面内。或者，锚定件可位于与闭塞面的周向边缘同一平面内。在一些实施方式中，锚定件可从线材框架的锚定件50近侧的一部分沿切向突出。
如参照图10A可见，框架可包括限定装置100的闭塞面106的瓣状物21。框架102的瓣状物21可沿与线材101螺旋形缠绕到孔眼110和112周围的相同方向扇形散开，如下面将更详细阐释那样。在一个示例中，每个瓣状物21相对于相邻的瓣状物21偏置约60度。瓣状物形状可变化(例如，通过改变从孔眼到瓣状物顶点的半径)，并且可采用更多或更少的瓣状物21。对于采用不同数目的线材101和瓣状物21的实施方式来说，瓣状物21可偏移开其它量。例如，对于具有四个瓣状物的四线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约90度。对于具有五个瓣状物的五线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约72度。对于具有八个瓣状物的八线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约45度。如参照图10A可见，每个瓣状物21可与相邻的瓣状物21的一部分重叠。例如，瓣状物宽度可随着包括更多或更少瓣状物而变化。瓣状物包括顶点23。瓣状物宽度可调节成根据应用场合提供期望的并置特征。例如，当瓣状物宽度加大以使得提供从孔眼110到瓣状物顶点23的较大半径时，可从装置向瓣状物21的顶点23处的周围组织赋予更小的并置力，相反地，当瓣状物宽度减少以使得提供从孔眼110到瓣状物顶点23的较小半径时，可从装置向瓣状物21的顶点23处的周围组织赋予更大的并置力。以此方式，装置的组织并置特征可基于装置缠绕参数来调节。
如参照图10A可见，锚定件50可位于装置的瓣状物21的顶点23处或附近。第一箍套56可位于顶点23的第一侧，而第二箍套57可位于顶点23的第二侧。当装置处于细长输送构造下时，诸如当输送装置时被约束在输送导管或套管的内腔中时，孔眼110、112分开，以使细长构件101被基本上拉直或拉成直线呈输送构造。在输送构造下，锚定件50类似地被基本上拉直或拉成直线，因而，锚定件50的组织接合部54可以基本上与对应的细长构件101接触。例如，细长构件101可缩拢到组织接合部54附近的区域内。
当装置从导管展开并且进入输送部位处的体腔的较少约束环境内时，装置呈其展开构造(例如，基于细长构件101的形状记忆特性)。由此，细长构件101在展开构造下形成具有顶点23的弯部，而细长构件101造成使锚定件的第一箍套56与第二箍套57连接的锚定件连结部55弯曲，并顺应于细长构件101。箍套连结部55能以此方式弯曲，因为它可以在一些实施方式中比细长构件101更挠性。当这发生时，锚定件的组织接合部54可保持大致平直，因而，当顶点23展开时，组织接合部54有效地产生抵靠于输送部位处的组织的高接触力。在闭塞左心耳的示例中，装置的展开可在心耳口部附近的区域内产生高接触力。在一些示例中，锚定件不包含在装置内，且细长构件的顶点23可在装置展开时产生高接触力，并且在这种情况下，细长构件本身可将装置锚定在位。类似地，在一些示例中，锚定件50可包括设计成与组织无创伤地接合而不刺穿组织的组织接合部54。
在一些示例中，一个或多个锚定件50可在框架102上设置在框架102上的圆筒形区域107内，例如就在接合部130近侧(例如参见图1中的锚定件50a)。在一些示例中，一个或多个锚定件50可在框架102上的渐缩区域108内设置在框架102上，例如就在接合部130远侧(例如参见图1中的锚定件50b)。在一些示例中，锚定件50可在框架102上设置在圆筒形区域107和渐缩区域108内。在这种示例中，锚定件可设置在具有相对较大弯曲半径的弯部115上，或者沿框架102的基本上平直的一部分设置。在总体实施例中，闭塞装置100可包括任何合适数目的锚定件50。在一些实施方式中，可省略锚定件50a和50b。
锚定件50可从框架102(例如，在圆筒形区域107内、在渐缩区域108内、在接合部130处或沿闭塞面106的周向边缘114从框架102)或其组合和子组合、以相对于框架的锚定件近侧的一部分以各种角度(例如，以锐角、直角或钝角)延伸。在一些示例中，锚定件50中的一个或多个可从框架102在锚定件附近的一部分沿切向延伸(例如，在圆筒形区域107内、在渐缩区域108内、在接合部130处或沿闭塞面106的周向边缘114从框架102延伸)。在一些示例中，锚定件50中的一个或多个或者全部可如图2中箭头51所示以大致顺时针方向从框架102延伸。在一些示例中，锚定件50中的一个或多个或者全部可如图2中箭头53所示以大致逆时针方向从框架102延伸。在一些示例中，闭塞装置100可包括以大致顺时针方向从框架102延伸的一些锚定件50和以大致逆时针方向从框架102延伸的一些锚定件50。锚定件50可由诸如非永久的可生物降级或可生物吸收材料的任何合适材料制成。例如，锚定件50可以由镍钛诺(NiTi)、L605钢、不锈钢或任何其它合适的可生物兼容材料制成。在一些示例中，各锚定件可由不同材料制成(例如，不是所有锚定件由相同材料制成)。
实施例可具有切向突出或凸出到闭塞面106的周向边缘114的锚定件。实施例可具有大致切向突出或凸出到闭塞面106的周向边缘114的锚定件。实施例可具有在与闭塞面106相同或基本上相同的平面内以锐角突出或凸出到闭塞面106的周向边缘114的锚定件。在一些示例中，锚定件的组织接合部可以约30-60度的锐角突出，并且在一些情况下以约20度或约30度或约40度或约50度或约60度的角度突出。在一些实施方式中，在相对于闭塞面106的相同平面内并且以相对于周向边缘114的锐角突出的锚定件可提供可将装置输送和重新捕获到输送导管内的优点，例如如果期望移除或重新定位该装置。
对于关于可用于文中所述装置的锚定件类型的附加信息，参见2012年9月13日提交的、发明人为Edward E.Shaw的题为“Medical Device Fixation Anchors(医疗装置固定锚定件)”的共同待审美国专利申请，该申请为了所有目的以参见的方式纳入本文。
闭塞装置100可由多细长构件框架102构成。在一些实施方式中，细长构件可以是线材，并且随后为了简便可被称为线材。多线材框架102可由相对挠性的抗疲劳细长构件101、例如线材的多个独立段构成。多线材框架102可以是半刚性的。可扩张框架102可由任何数目的耐疲劳细长构件101构造而成。可扩张框架102能以适于应用的任何尺寸来形成。人的左心耳口部的尺寸范围从约10到约32毫米，平均为约21毫米正负约4毫米。装置尺寸可制造成包含口部尺寸的整个范围。实施例可具有多个细长构件、例如用于制成该装置的四个、五个、六个、七个、八个、九个或更多个线材。可扩张框架102可由具有弹性的线材、例如耐疲劳线材构造而成。可扩张框架102由具有弹性的线材构造而成，弹性允许可扩张框架102塌缩以进行基于导管的输送或胸腔镜输送，并且一旦定位在腔内就自扩张到期望的构造。弹性线材可以是弹簧线材、形状记忆合金线材或超弹性合金线材。可采用具有可生物兼容特征并且牢固、挠性和弹性的任何线材。例如，该线材可以是镍钛诺、L605钢、不锈钢或任何其他可生物兼容线材。弹性线材还可以是在芯部处包含不同金属的拉拔填充型镍钛诺。镍钛诺的超弹性使它对于这种应用来说是有效的材料。镍钛诺线材可热固成期望的形状。不锈钢线材是替代的材料。它可以塑性变形成期望的形状。还可使用利用无心磨削技术成形为具有多个直径的线材。其它形状记忆或可塑性变形材料也可适于该应用。在一个实施例中，可扩张框架102可由在中心处包含诸如铂的不透辐射的金属的拉拔填充型NiTi线材构造而成。在展开时，线材结构恢复其展开的形状，而不是永久地变形。可扩张框架102和可扩张框架的其它实施例可由具有约0.12到约0.14毫米的外直径(OD)的弹性线材材料构成。其它实施例可由约0.3毫米外直径的线材构成。
多线材框架102可部分地或基本上覆盖有隔膜104。如图1到2中所示，隔膜部件104构造成抑制血液通过。实施例可提供隔膜部件104，该隔膜部件104构成抑制血液通过隔膜，即，基本上闭塞通过隔膜的血流。其它实施例可提供如下隔膜部件104，即，该隔膜部件构造成引起快速组织内生长，该隔膜部件还立即闭塞血液通过隔膜。在一实施例中，隔膜部件104提供不透血液或人体流体的隔膜，该隔膜闭塞通过该隔膜的血流或人体流体流，但还促进组织内生长和内皮化。这种实施例可包括诸如膨胀型聚四氟乙烯聚合物隔膜的含氟聚合物隔膜。抑制血液或人体流体通过隔膜部件104可以是立即的，并且可以不依赖于血栓形成过程。隔膜部件104还可用作组织内生长支架，以持久地闭塞和锚定该装置。
隔膜部件104的多微孔结构能专门设计成促进组织内生长和/或内皮化。隔膜部件104可通过各种化学或物理过程来修改，以加强一定的机械或物理特性。亲水性涂层可涂覆到隔膜部件104，以促进其湿润性并回声半透性。此外，可采用物理化学修改，由此隔膜部件104包括化学部分，这些化学部分促进内皮细胞附连、迁移和/或繁殖，或抗血栓形成。用共价键合肝磷脂改性的表面是隔膜改性的一个示例。隔膜部件104能永久植入在口部上。隔膜部件104可由任何可生物兼容材料制成，可生物兼容材料包括诸如聚四氟乙烯和膨胀型聚四氟乙烯的含氟聚合物；聚酯；硅酮；聚氨酯或其它可生物兼容聚合物及其组合物。实施例可包括隔膜部件，该隔膜部件包括诸如聚四氟乙烯和膨胀型聚四氟乙烯的含氟聚合物。在又一实施例中，隔膜部件包括膨胀型聚四氟乙烯。
现参照图3，闭塞装置100包括由多个细长构件或线材101构成的框架102。尽管框架102示出为在图3的实施例中包括六个线材101，但框架102一般可包括任何合适数目的线材101(例如，四个、五个、七个、八个、九个、十个或更多个线材101)。线材101在框架102的近端处构成近侧孔眼110并从该近侧孔眼110延伸到框架102的远端处的远侧孔眼112，其中，远侧孔眼112由线材101构成。在孔眼110和112之间，线材101扇形散开以提供用于装置100的闭塞特征和锚定特征。闭塞面106例如设置在框架102的近端附近。如图3中所示，装置100的框架102和特别是近侧孔眼110和远侧孔眼112示出为安装在芯轴44上，如下面将描述那样，该芯轴可用于制成装置100。间隔管52在近侧孔眼110和远侧孔眼112之间和芯轴44上延伸，以使孔眼110、112间隔开期望的量。
在图4A-B中示出锚定件50和60的实施例。图4A示出由一段镍钛诺管子切割成的锚定件60，该锚定件具有组织接合构件54(例如，倒钩)和锚定件保持箍套59。锚定件保持箍套59可通过任何合适的方法附连到线材101。锚定件保持箍套可借助机械配合、焊接或粘结剂附连到线材101。图4B示出具有组织接合构件54、第一锚定件保持箍套56和第二锚定件保持箍套57的锚定件50。锚定件(50,60)尺寸可设计成具有将适应形成装置100所需的任何线材101尺寸的内直径。锚定件50和60中的任一个或两个可单独或结合使用。例如，细长构件弯部115可对应于图10A中的顶点23。
在一些示例中，即便不使用锚定件50、60，弯部115也可例如向框架102提供锚定特征。例如，弯部115可适于与输送部位(例如，左心耳)处的组织接触、接合或刺穿该组织，以将闭塞装置100锚定到输送部位，并且在这种示例中，线材弯部115本身可被认为是主锚定件或者提供主锚定特征。以此方式，装置100的框架102的一个或多个部分可用于将装置锚定在输送部位处。
再次参照图3，线材101相对挠性、耐疲劳和半刚性，因而，框架102能在展开构造下呈规定形状，并且能在插入输送系统的部件(例如，输送套管)内时可塌缩到输送构造。线材101可以例如是具有弹性特性的耐疲劳线材。弹性特性可允许框架102为基于导管的输送或胸腔镜输送而塌缩，并且在定位于体腔内时自扩张到期望构造。线材101可以是弹性线材、形状记忆合金线材或超弹性合金线材。在一些示例中，线材的一个或多个部分可比线材101的一个或多个其它部分更挠性或更不挠性。一般来说，线材101可包括具有可生物兼容特征并足够牢固、挠性和弹性的任何细长构件。
线材101可由镍钛诺(NiTi)、L605钢、不锈钢或任何其它合适的可生物兼容线材制成。线材101还可由拉拔填充型NiTi制成，并包括不同材料制成的金属芯部。镍钛诺的超弹性性能使NiTi是这种线材101的特别好的备选材料(例如，NiTi线材可热固成期望的形状)。在一些实施例中，由不锈钢制成的线材101可塑性变形成期望的形状。在一些实施例中，线材101可用无心磨削技术形成有可变直径。在一些实施例中，线材101可由其它形状记忆或塑性变形材料制成。在一些实施例中，线材101可由拉拔填充型NiTi线材制成，该NiTi线材在线材101的中心处包括诸如铂的不透辐射的金属。在展开时，这种线材101可重新呈其展开形状，而不永久变形。在一些实施例中，线材101可具有约0.12毫米到约0.4毫米(例如，0.3毫米)的外直径。线材101可具有任何合适的横截面形状。例如，在一些实施例中，线材101可具有圆形、椭圆形、正方形、矩形、钻石形或其它多边形横截面形状。在一些实施方式中，线材101可包括带纹理表面，带纹理表面在与输送部位处的组织接触、不论是与组织直接接触或者经由可设置在线材101与组织之间的隔膜104接触时更能够阻止脱开。
再次参照图1和2，框架102可部分地或基本上覆盖有隔膜104，该隔膜构造成抑制血液通过(即，隔膜104可基本上闭塞血液流经隔膜104)。在一些实施例中，隔膜104构造成引起快速组织内生长，并能立即闭塞血液通过隔膜104。在一些实施例中，隔膜104不透血液或其它人体流体。在一些示例中，抑制血液或人体流体流过隔膜104是立即的，而不是依赖于血栓形成过程。在一些实施例中，隔膜104可具有微孔结构，微孔结构提供用于持久闭塞和锚定闭塞装置100的组织内生长支架。在一些实施例中，隔膜104可提供促进内皮化的微孔结构。隔膜的一些这种实施例包括含氟聚合物，诸如是膨胀型聚四氟乙烯(ePTFE)聚合物。
在一些示例中，隔膜部件104可通过各种化学或物理过程来修改，以加强一定的机械或物理特性。例如，可将亲水涂层涂覆到隔膜104上，以提供或改善隔膜104的润湿性和回声半透性。在一些实施例中，隔膜104可用促进包括内皮细胞附连、细胞迁移、细胞繁殖和抗血栓形成的一个或多个过程的化学部分来修改。例如，隔膜104可用共价键合肝磷脂来修改。在一些示例中，隔膜104可构造成永久地植入到左心耳口部上。隔膜104可由任何合适的可生物兼容材料制成，可生物兼容材料包括诸如聚四氟乙烯(PTFE)和ePTFE的含氟聚合物；聚酯；硅酮；聚氨酯或其它可生物兼容聚合物及其组合物。
仍参照图1和2，闭塞装置100能并且如上所述在一些实施例中包括设置在框架102的一个或多个区域上的一个或多个锚定件50，其中，锚定件50可适于刺穿输送部位处的组织，以将闭塞装置100锚定在输送部位处。在一些示例中，锚定件可构造成与组织无创伤地接触，而不刺穿组织。隔膜104可包括允许锚定件50穿过隔膜104的孔洞或者锚定件能在一些实施方式中简单地刺穿隔膜104。
在一些示例中，一个或多个锚定件50可沿框架102的周向部分设置在弯部或顶点115(参见图3、4A、4B)中的一个或多个上，并在闭塞面106的周向边缘114处(参见图1、2)延伸通过隔膜104。在一些示例中，锚定件50可设置在半径比图4A和4B中所示弯部115大或小的弯部115上。在一些实施例中，一个或多个锚定件50可设置在框架102的与闭塞面106的周向边缘114间隔开的区域上。例如，一个或多个锚定件50可在闭塞装置100从圆筒形区域107过渡到渐缩区域108的接合部130附近设置在框架102的弯部115(例如，具有相对较大半径的弯部115)上。
参照图5-8C，将描述组装诸如装置100的闭塞装置的示例。获得具有约0.23毫米直径和约1米长度的10％铂拉拔填充型NiTi线材(例如，来自印第安纳州韦恩堡的韦恩堡金属公司)，以形成闭塞装置100的线材101。可以测量或不测量线材101的具体长度，但线材101应长到足以完成如下面段落中所述的缠绕式样。在一些示例中，获得经电解法抛光的线材101。电解法抛光NiTi赋予某些熟知的特性。例如，电解法抛光可诱使在线材101表面上自发形成二氧化钛层，从而可选地减少线材101表面上的镍量，减少线材101内的一定应力，以及由此提高线材101的抗疲劳特性。
图5示出用于缠绕诸如装置100的闭塞装置的基座夹具8。将分别具有约1米长度的三根线材101对折，使线材101的自由端馈送通过线材馈送孔10、12、14、16、18和20。例如，线材101穿过漏斗状开口19，然后在开口19的底部离开小馈送孔10、12、14、16、18和20。特别是参照图6，线材101在基座夹具8的平坦端面处通过孔10、12、14、16、18和20离开。将配重物附连到六根线材101的自由端，以保持线材101拉紧和在位。特别是参照图5和7，将基座夹具8固定在车床卡盘内，并将中心销22插入基座夹具8内的中心销孔24内(参见图5)深到足以使中心销22牢固地安置(参见图7)。将基座夹具8定位成使线材馈送孔10、12、14、16、18和20在中心销22上方垂直定向，且线材101定位在中心销22的尾侧。
特别是参照图7，使瓣状物夹具孔36转动约720度，以通过使线材101缠绕在中心销22周围来形成闭塞装置100的近侧孔眼110。特别是参照图8A，将瓣状物夹具38插入瓣状物夹具孔36内。在线材101不交叉的情况下，将线材101放置于瓣状物夹具38的顶上。在一些示例中，可将诸如图1和2中所示的锚定件50之类的锚定件附连到线材101。例如，可将一个或多个锚定件50(未示出)在装置100处于展开位置时的线材的顶点处或附近附连到一个或多个线材，并且顶点可对应于线材缠绕在瓣状物夹具38的倒圆边缘39周围的位置。以此方式，当处于展开位置时，锚定件可位于装置100的闭塞面106的周向边缘114(参见图1)处或附近。在其它示例中，可将一个或多个锚定件50远离顶点或者线材缠绕到瓣状物夹具38的倒圆边缘39周围的位置而附连到一个或多个线材。例如，可将一个或多个锚定件50沿任一方向按情形(例如，沿瓣状物夹具38的略弯曲部)在离开如下位置约0.1cm、0.2cm、0.3cm或0.4cm之处附连到一个或多个线材101，在该位置，线材缠绕到瓣状物夹具38的倒圆边缘39周围。锚定件可通过已知的附连方法中的任一种来附连，这些附连方法诸如是粘合、焊接、压褶、夹带、过盈或者通过将它们制成框架的一体部分。在一些示例中，锚定件50可包括大致“V”形，并由管子制成，管子的内直径的尺寸适应线材101的外直径。锚定件50可在线材上滑动并滑到相对于瓣状物夹具38的位置，如图8A、8B和8C中所示，在该位置，“V”形锚定件在瓣状物夹具38的倒圆边缘39处定位在线材101上。以此方式，锚定件可位于装置100在处于展开位置时的顶点处。
特别是参照图8A和8B，基座夹具8转动约360度，以形成闭塞装置100的框架102的瓣状物21(参见图9)。锚定件77可代表文中讨论的锚定件中的任一种，或者可代表不同类型的锚定件。特别是参照图8C，基座夹具8又转动约另一个720度，而线材101放置于中心销22的顶上，以形成远侧孔眼112。将线材枢轴7插入夹具8的线材枢轴孔9内。将线材101馈送到线材枢轴7周围，并放置于基座夹具8的锚定件板11下方。用螺钉15将锚定件板11固定到基座夹具8。在锚定件板11的加重侧上切割线材101。
在移除配重物的情况下，例如可将组件放置于设定到约475℃的温度下的对流炉内约15分钟。该组件从炉内移除，并在水中淬火。然后，可拆下夹具8和38，并且可移除部分成形的闭塞装置(参见图9)。
参照图10A和10B，线材端部修整到孔眼110和112，框架102的瓣状物21沿与线材101螺旋形地缠绕到孔眼110和112周围的相同方向扇形散开，因而，每个瓣状物21相对于相邻的瓣状物偏移约60度。对于采用不同数目的线材101和瓣状物21的实施方式来说，瓣状物21可偏移开其它量。例如，对于具有四个瓣状物的四线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约90度。对于具有五个瓣状物的五线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约72度。对于具有八个瓣状物的八线材装置来说，每个瓣状物可相对于相邻的瓣状物偏置约45度。如参照图10A可见，每个瓣状物21可与相邻的瓣状物21的一部分重叠。
参照图11A和11B，获得热固芯轴44。将间隔管52放置于孔眼110和112之间。参照图12A-12C，然后将热固芯轴44连同部分成形的闭塞装置放置于热固工具48内，以使装置100的瓣状物21定位在热固工具48内部。将热固芯轴44插入基板46的中心孔内。热固工具48定位成实现瓣状物21的期望角度，并且使用加捻扎线来将线材101捆绑在一起。可将组件放置于设定到约475度的温度下的对流炉内约15分钟，然后移除并用水淬火。
尽管保持瓣状物21的期望定向，部分成形的闭塞装置能以如下方式用氟化乙丙烯(FEP)粉末来进行粉末涂覆。将框架102、间隔管52和热固芯轴44插入混合器(例如，康涅狄格州托林顿瓦宁公司可变速度实验室混合器)内。热固芯轴44的一端接地。将一定量的FEP粉末添加到混合器内，同时使混合器叶片的末端露出。将框架102、间隔管52和热固芯轴44悬置于混合器的中心区域内，将盖子置于混合器上，并且将混合器接通到最高设定约5秒钟。将框架102、间隔管52和热固芯轴44移除，并且敲打热固芯轴44，以实现框架102上的更均匀的粉末涂层。将低度真空施加于锚定点以去除任何多余FEP粉末，然后，将框架102、间隔管52和芯轴44悬置于设定到约320℃的温度下的对流炉内约3分钟。
现在参照图13，从炉内移除框架102、间隔管52和芯轴44，并允许进行冷却。然后，可抽出芯轴44，并从两个孔眼110、112之间移除间隔管52。参照图14A和14B，示出被压褶的芯轴123，并且包括彼此间隔开适当距离的第一和第二压褶部124。压褶部可在某些加工步骤、诸如粉末涂覆和移植物附连过程中保持孔眼分开。通过用镊子来抓持近侧孔眼110和远侧孔眼112来使框架102在被压褶的芯轴123上沿长度延伸。孔眼110和112固定在超出芯轴123内的压褶部124的位置处。
闭塞装置100的隔膜104可在一些实施方式中包括多孔ePTFE膜。隔膜104可在一些实施方式中具有如下特性：约0.7磅/平方英寸(psi)的甲醇泡点；约2.43g/m2的质量/面积；约96000磅/平方英寸(psi)的纵向基质拉伸强度；约1433磅/平方英寸的正交基质拉伸强度；约1.6kg/英寸的纵向最大负载；以及约0.00889mm的厚度。采用具有1英寸检尺径(diameter foot)、0.2psi/秒的斜率以及液态的甲醇介质的定制机器来测定甲醇泡点。可采用金属尺来测量材料的长度和宽度。采用天平(例如，加利福尼亚州圣荷西的ANG的型号GF-400)、借助36x5英寸的试样来测量质量/面积。采用装有10公斤测压元件的材料测试机(例如，宾夕法尼亚格罗夫城的Instron型号5564)来测量纵向最大负载。标距长度为1英寸，而十字头速度为25毫米/分钟。试样宽度为1英寸。沿材料的长度方向获得纵向拉伸试验测量值。采用1/4英寸检尺径的厚度量规(例如，Mitutoyo数字指示器547-400)来测量厚度。采用下述等式来计算纵向基质拉伸强度(MTS)：
其中，ρPTFE＝2.2克/立方厘米
σ试样＝(最大负载/宽度)/厚度
ρ试样＝(质量/面积)/厚度
密度计算为质量除以体积。
30毫米的膜管能以如下方式由ePTFE材料制成。对于25毫米直径的闭塞装置，将具有约1.905厘米的狭槽宽度的膜缠绕到30毫米外直径的芯轴上。膜交叠的程度可变化，但较佳地边缘存在至少一定的交叠。然后，从芯轴移去管子，并使管子伸展直至管子的内直径制成约25毫米。
然后，采用ePTFE膜使膜管在张紧的物件上滑动，并且可将管子的端部箍绑在两个孔眼110、112周围。在一些实施方式中，获得具有如下特性的涂覆有FEP粉末层的另一多孔ePTFE膜：约36.1g/m2的质量/面积；约12.6kg/英寸的纵向最大负载；约0.3kg/英寸的横向最大负载；以及约0.0012英寸的厚度。膜内的FEP厚度约为62.5％。FEP厚度(％)计算为FEP厚度与膜的厚度之比。所报告的值表示针对五个试样的平均测量值。以如下方式通过扫描ePTFE/FEP层叠物材料的横截面的电子显微图像测得FEP厚度和膜的厚度。放大倍率选择成使得能看到整个膜厚度。随机将与图像的水平边缘垂直的五条线拉过膜的全厚度。通过测量FEP厚度和膜的厚度来确定厚度。
将涂覆有FEP的ePTFE膜(FEP面向下)的2毫米宽的条带四次缠绕到箍紧部分周围，并借助烙铁来加热以使膜层接合在一起。将闭塞装置100(如图1和2中所示)和芯轴放置于设定到约320℃的温度下的对流炉内约3分钟，然后移除并允许进行冷却。裁剪多余的ePTFE材料。
上述示例中的一些包括具有附连到装置框架102的一个或多个线材101(例如，参见图1、2、8A-8C和9)分开的锚定构件50的闭塞装置的实施例以及框架102的线材101内的弯部115本身用于将装置锚定在输送部位处(例如参见图3、4A、4B)的实施例。在一些实施方式中，闭塞装置可形成为使得闭塞装置的线材中的一个或多个限定与装置成一体的锚定特征。特别是，闭塞装置可形成为其线材中的一个或多个限定与装置的锚定臂成一体的锚定特征，且其中锚定臂总地限定装置的锚定区域。
除了涉及上述和以下所要求的各种教导，还设想具有上述和以下要求的特征的不同组合的装置和/或方法。同样，本发明还涉及具有以下要求的从属特征的任何其它可能组合的其它装置和/或方法。
前面的描述已经给出了许多特征和优点，包括各种替代的实施方式，以及装置和/或方法的结构和功能的细节。本文所述仅表示示例性的且同样并不表示为排它性的。对于本领域的技术人员来说显然可在本发明的原理范围内在所附权利要求书所表达术语的宽泛上位含义所指示的最大范围内进行各种改型，尤其是在结构、材料、元素、部件、形状、尺寸和部件的布置。在这些多种改变不偏离所附权利要求书精神和范围的程度上，它们属于本发明范围内。

Claims (18)

1.一种闭塞装置，所述闭塞装置包括：
框架元件，所述框架元件具有多根线材并且具有输送构造和展开构造，所述框架元件包括：
远端，
近端，
大致平坦的闭塞面，该闭塞面具有周向边缘，大致平坦的闭塞面由在所述闭塞面的区域内围绕所述框架元件的纵向轴线、沿顺时针和逆时针方向中的一者弯曲的多根线材的各部分形成，并且在展开构造中构造成顺应于口部的形状并且朝向所述框架元件的所述近端定位，且所述大致平坦的闭塞面的直径构造成在闭塞装置的展开过程中通过将扭矩传递到框架而进行调节；
渐缩区域，在展开构造中所述渐缩区域在所述远端与所述近端之间延伸；
至少一个锚定件，所述至少一个锚定件定位在框架元件的外部上；以及
覆盖框架元件的隔膜。
2.如权利要求1所述的闭塞装置，其特征在于，所述多个线材构造成扇形散开以构成用于所述闭塞装置的闭塞特征和锚定特征。
3.如权利要求2所述的闭塞装置，其特征在于，所述锚定特征包括位于所述框架元件的多个线材内的弯部。
4.如权利要求1所述的闭塞装置，其特征在于，在所述框架元件的渐缩区域内，所述至少一个锚定件布置于并且附连到所述框架元件的一部分。
5.如权利要求1所述的闭塞装置，其特征在于，还包括布置于近端处的近侧孔眼、布置在远端处的远侧孔眼以及延伸穿过所述近侧孔眼、远侧孔眼和装置的长度的内腔。
6.如权利要求1所述的闭塞装置，其特征在于，所述至少一个锚定件定位在所述大致平坦的闭塞面的周向边缘处。
7.如权利要求1所述的闭塞装置，其特征在于，所述渐缩区域构造成顺应于可变锥度。
8.如权利要求1所述的闭塞装置，其特征在于，所述隔膜构造成抑制血液通过。
9.如权利要求8所述的闭塞装置，其特征在于，所述隔膜包括含氟聚合物。
10.如权利要求8所述的闭塞装置，其特征在于，所述隔膜包括聚四氟乙烯。
11.如权利要求8所述的闭塞装置，其特征在于，所述隔膜包括膨胀型聚四氟乙烯。
12.如权利要求1所述的闭塞装置，其特征在于，所述框架包括多个线材。
13.如权利要求12所述的闭塞装置，其特征在于，所述多个线材包括镍钛诺。
14.如权利要求1所述的闭塞装置，其特征在于，所述框架元件包括圆筒形区域，所述圆筒形区域从所述大致平坦的闭塞面沿大致远侧方向延伸第一距离，而所述渐缩区域从所述圆筒形区域的远端延伸到所述框架元件的所述远端。
15.如权利要求14所述的闭塞装置，其特征在于，还包括设置在所述圆筒形区域和所述渐缩区域的接合部附近的一个或多个锚定件。
16.如权利要求1所述的闭塞装置，其特征在于，所述框架元件包括瓣状物形状和所述瓣状物形状的顶点，且所述瓣状物形状的顶点包括所述框架元件内的弯部。
17.如权利要求16所述的闭塞装置，其特征在于，还包括位于所述瓣状物形状的顶点处的至少一个锚定件。
18.如权利要求17所述的闭塞装置，其特征在于，所述至少一个锚定件包括第一箍套和第二箍套，且所述框架元件穿过所述第一箍套和第二箍套中的每个，且所述第一箍套定位在所述顶点的第一侧，而所述第二箍套定位在所述顶点的与所述第一侧不同的第二侧。
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EP3061402A1 (en) 2016-08-31
RU2014115208A (ru) 2015-10-27
AU2012308322A1 (en) 2014-03-13
JP2017196447A (ja) 2017-11-02
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US20210038230A1 (en) 2021-02-11
US20170181751A1 (en) 2017-06-29
CA2972536C (en) 2019-07-09
AU2012308322B2 (en) 2016-04-07
EP3560430A1 (en) 2019-10-30
AU2016204722A1 (en) 2016-07-28
KR101942129B1 (ko) 2019-01-24
US11457925B2 (en) 2022-10-04
JP2014531249A (ja) 2014-11-27
EP2755561B1 (en) 2016-03-23
KR20140062160A (ko) 2014-05-22
CA2846903A1 (en) 2013-03-21
ES2960497T3 (es) 2024-03-05
US20140379019A1 (en) 2014-12-25
US9597086B2 (en) 2017-03-21
BR112014005679A2 (pt) 2017-03-28
CN103945775A (zh) 2014-07-23
US20240041467A1 (en) 2024-02-08
US9554806B2 (en) 2017-01-31
EP4265200A2 (en) 2023-10-25
EP3061402B1 (en) 2019-07-24
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US20130245666A1 (en) 2013-09-19
JP6499229B2 (ja) 2019-04-10
EP2755561A1 (en) 2014-07-23
CA2846903C (en) 2017-07-18
ES2750566T3 (es) 2020-03-26
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HK1198900A1 (zh) 2015-06-19

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