CN101384294B - 左心耳封堵装置 - Google Patents

左心耳封堵装置 Download PDF

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CN101384294B
CN101384294B CN2006800452341A CN200680045234A CN101384294B CN 101384294 B CN101384294 B CN 101384294B CN 2006800452341 A CN2006800452341 A CN 2006800452341A CN 200680045234 A CN200680045234 A CN 200680045234A CN 101384294 B CN101384294 B CN 101384294B
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亚历克斯·杰沃伊斯
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Abstract

本发明提供用于封堵左心耳的装置和方法。该装置包括易于部署的由形状记忆材料制成的线结构，其尺寸经确定以适用于患者。该装置可制造成不同的尺寸以用于不同的患者。该装置具有所附接的一片用于遮蔽左心耳开口的材料以及用于可靠地附接于大体左心耳内的装置。该方法包括：将该装置部署于左心耳内，可靠地锚固该装置，以及确保一片材料遮蔽左心耳开口。这些特征被纳入改良的装置和方法中，以便更有效地帮助防止凝块形成和凝块移入或移出左心耳，从而大大地减小患有房颤的患者出现中风的风险。

Description

左心耳封堵装置
发明背景
左心耳是从左心房的上前部分的小圆锥形突起。心耳中的血池可能自然地产生或因房颤而产生。当血在心耳中形成血池时，可能形成血凝块。当自左心耳向血流移动的凝块在动脉系统中栓塞时，可能引起严重的问题。在房颤期间形成的超过90％的凝块是在左心耳中形成的。Sievert等人所著的“循环105：1887-1889(2002)”。这些凝块的栓塞是中风的常见原因。因此，防止在左心耳中形成凝块或凝块从左心耳移动可减少患有房颤的患者的中风的发生。
减少凝块形成的常用方法是使用抗凝剂(例如华法林(warfarin))。该疗法已成为减少中风发生的有效方法。然而，在使用抗凝剂的患者中，如果在治疗中存在必要的或意外的误差，仍然会发生中风。另外，许多处于中风危险中的患者禁止使用抗凝剂。抗凝剂疗法是有效的，但是，由于持续地治疗患者中所存在的困难以及存在经常禁止使用抗凝剂的情况，使人们产生了获得不同治疗方案的需求。
另一设计为减少会导致中风的凝块和栓塞的治疗方法是左心耳封堵。显然，在房颤期间，心耳封堵将导致较少的凝块。在心脏手术或通过侵入性较小的胸腔镜手术期间，可能发生闭塞。许多处于高中风危险下的患者不适合进行这些手术，因为这会危及其健康状况。另外，左心耳闭塞可能具有尚未充分研究的不利的血流动力学和激素影响。参见Al-Saady等人所著的“心脏82：547-554(1999)”。
由于抗凝剂治疗和左心耳的手术闭塞的限制，人们需要具有较小侵入性的方法和装置来帮助防止凝块从左心耳移动到血流中。
已开发了各种装置并用于左心耳封堵。一种该装置包括封闭在聚四氟乙烯膜内的镍钛诺笼。该装置经设计以完整地插入左心耳中并具有多个锚固件以附接到左心耳的内壁。由于该装置经设计以完整地插入左心耳中，所以该装置必须经合适地尺寸确定以确保完全封堵左心耳。该装置的不合适尺寸可能导致植入时间延长或者如果植入错误的尺寸，会降低该装置的效率。
另一种装置包括由聚四氟乙烯膜部分覆盖的线笼。该装置也经设计以完整地插入左心耳内且不包括用于附接到左心耳内的锚固件。与上面相同，该装置的不合适尺寸可能导致植入时间延长或效率降低。另外，由于缺少锚固机构，如果将该装置移出左心耳，就可能导致更严重的并发症。
用于左心耳封堵的又一种装置包括双圆盘镍钛诺网，其经设计以通过夹持到左心耳的开口来进行封堵。该装置不包括用于附接到左心耳的肌肉组织的锚固件，且必须经合适地尺寸确定以防止该装置移出左心耳。同样，该装置的不合适尺寸可能导致植入时间延长或更严重的并发症。
因此，现有技术的装置的缺点可能导致较长的手术时间、左心耳的不完全封堵、挤压冠状动脉或者因将该装置移出左心耳而引起严重并发症。另外，常规装置过大，从而会潜在地引起左心耳拉伸。例如，常规装置可能过大达20-25％。该拉伸可能导致溃疡或心律不齐
发明概要
本发明的目的是提供用于左心耳封堵的改良的装置和方法，所述装置和方法确保完全封堵或大体上完全封堵左心耳，以帮助防止凝块形成和凝块自左心耳移动，从而减小患有房颤的患者中风的风险。
本发明的目的是提供用于左心耳封堵的装置，其可有效地锚固到左心耳的肌肉组织上，以防止该装置过度移动或该装置移出左心耳。
本发明的目的是提供用于左心耳封堵的装置，所述装置将独立于患者的生理状况提供左心耳的完全封堵或大体上完全封堵，以减少植入时间并减少不合适确定尺寸的装置所引起的并发症。
本发明的一个实施例提供左心耳封堵装置，所述装置包括：可变形的线，其形成第一预定扩展形状和第二预定松驰形状；至少一个锚固件，其适合将该装置附接到左心耳组织；以及片，其中该片附接到该线上；其中该第一预定扩展形状是大体线性的；其中该第二预定松驰形状是大体盘绕形状，该大体盘绕形状包括多个线轨道；且其中当可变形的线形成第二预定松驰形状时，在沿大体盘绕形状的纵轴线观察盘绕形状时，片大体上遮蔽大体盘绕形状的内部截面。
本发明的另一实施例提供左心耳封堵装置，所述装置包括：可变形的线，其形成第一预定受约束形状和第二预定松驰形状；至少一个锚固件，其适合将该装置附接到心耳组织；以及片，其中该片附接到该线上；其中该第一预定受约束形状是大体线性的；其中该第二预定松驰形状是锥体，该锥体包括多个线轨道；且其中当可变形的线大体上不受约束时，在沿锥体的纵轴线观察锥体时，片大体上遮蔽锥体的内部。
本发明的再一实施例提供左心耳封堵装置，所述装置包括：包括形状记忆合金的可变形的线，其形成第一预定扩展形状和第二预定松驰形状且具有近端和远端；至少一个锚固件，其适合将该装置附接到组织上；附接到该线上的织物；其中该第一预定扩展形状是大体线性的且第二预定松驰形状是大体圆锥形的，该圆锥形包括具有从线圈的近端到线圈的远端大致减小的直径的多个环圈，且其中当该线形成第二预定松驰形状时，该片大体上覆盖在沿线圈的纵轴线观察时可见的开口，该开口由处于盘绕线圈的近端的环圈限定。
本发明的又一实施例提供一种封闭人或动物心脏的左心耳的方法，其包括：在心脏的左心耳内部署线和片组件；将线构件锚固到心脏的组织上；以及导引该线形成大体盘绕形状以便该片大体上覆盖左心耳的开口。
应理解，前面的大体说明和下文的详细说明只是示例性和解释性说明，而非限定所申请的本发明。
附图简述
根据下文说明、随附权利要求书以及以下附图中所显示的随附示例性实施例，本发明的上述和其它特征、方面和优点将变得一目了然。
图1是左心耳封堵装置的第一实施例的侧视图；
图2是图1中的装置的俯视图；
图3是左心耳封堵装置的第二实施例的侧视图；
图4是其中部置有左心耳封堵装置的左心耳的局部剖视图；
图5是其中部置有左心耳封堵装置的左心耳的另一局部剖视图；
图6a是处于扩展状态的线的视图，其中片附接到该线上；以及
图6b是显示根据本发明的带有片的装置的仰视图。
优选实施例详述
本发明提供用于封堵左心耳的装置和方法。该装置和方法可通过防止任何血流入左心耳而完全封堵左心耳，或者该装置和方法可通过仅允许最少量的血流入和流出左心耳而大体上封堵左心耳。该装置可包括易于部署的形状记忆材料的线结构，该线结构经尺寸确定以适用于任何患者。该装置可具有所附接的用于遮蔽左心耳开口的材料片和用于可靠地附接到大体上左心耳内的装置。该方法可包括将装置部署在左心耳内、可靠地锚固装置以及确保材料片遮蔽左心耳的开口。
将这些特征纳入改良的装置和方法中，以更有效地防止血流入左心耳及/或凝块形成和凝块移入或移出左心耳，以大大地减小患有房颤的患者中风的风险。
下面对本发明的详细描述图解说明某些示例性实施例，且能够实现对所申请的发明的更佳理解。
除非另有规定，否则本文中所用的“一个”、“该”均意指“一个或多个”。
图1显示处于松驰形状的左心耳封堵装置10。该装置具有可变形的线20，可变形的线20具有近端24和远端22，其中线20是处于其松驰形状的线圈，其具有连接近端和远端的多个轨道。图1和图2显示线圈20，线圈20在其松驰状态具有圆锥形形状，以便处于近端24的线轨道限定线圈的开口且与远端22附近的线轨道相比具有较大的直径。
或者，线圈20在其松驰状态可为圆柱形状，以便处于近端24和远端22的线轨道具有大体上相同的直径。另一实施例包括具有圆锥形形状的线圈20。本发明的其它实施例可包括不同的松驰状态形状，以便装置10和线圈20贴合患者的生理状况，以更好地实现装置的目的。在扩展状态中，线20是大体线性的。扩展的线形形状使装置能够经由导管腔输送到治疗位置。松驰状态形状将短于沿装置的纵轴线的扩展线形形状。松驰状态形状将长于沿垂直于装置的纵轴线的轴线的扩展线形形状。松驰状态形状选择成使装置10的线轨道大体上包围左心耳的内部空间，以确保装置的正确放置和功能。
线20可利用任何类型的合适形状记忆材料制成，该形状记忆材料将使线在被引入左心耳和其它治疗位置时形成较佳的松驰状态配置。针对其生物相容性(包括其抗血栓能力)来选择材料。线20材料可包括镍钛诺(R)、埃尔基洛伊耐蚀游丝合金(R)、钛、不锈钢或其它合适的材料。针对其形状恢复能力和其超弹性来选择形状记忆材料。所选择的材料可延伸成大体线性的形状，以经由导管输送到左心耳。在部署该装置后，材料能够恢复到适合放置到左心耳内的预定的松驰状态形状。
装置10可在其远端22处或靠近其远端22具有远端锚固机构30。锚固机构30可包括一个或多个远端锚固件35。远端锚固件35可为线形状，例如弯钩、倒刺或能够附接到左心耳的内部的肌肉组织的其它形状。远端锚固件35和远端锚固机构30可利用与线20不同的材料(例如刚性更大的材料)制成。远端锚固件35和远端锚固机构30可利用缝合线制成。缝合线可利用任何合适的缝合线材料(例如尼龙、聚丙烯纤维或聚丙烯)制成。针对其生物相容性和刚度来选择远端锚固件35和远端锚固机构30的材料，以确保将装置10正确放置到左心耳内或其它治疗位置，并防止装置过度移动，以实现防止血流入左心耳及/或凝块移出被封堵区域的目的。
图1中的远端锚固机构30包括附接到线20的附接线40。将附接线40在其近端附接到线20的远端，并将锚固件30附接到附接线40的远端。附接线40可比线20更加柔韧或刚硬。附接线40可为线20的接续，以便利用单一的整体式线形成附接线40和线20。针对其刚度或柔韧性来选择附接线的材料，以确保正确地放置装置10并使凝块的形成和移动最小。因此，可取决于患者的生理状况和移动量来改变附接线的刚度。
图1中的装置10还包括近端锚固机构50，锚固机构50包括一个或多个近端锚固件55，近端锚固件55附接到线20的近端24附近。近端锚固机构50可包括至少四个近端锚固件55，以确保装置10的正确放置。近端锚固件55可通过锡焊或其它合适的方式附接到线20上，以确保正确地附接到线上。近端锚固件55可为成形为弯钩、倒刺或能够附接到左心耳的内部的肌肉组织的其它形状的线，以确保正确地放置装置10。近端锚固件55可利用缝合线制成。缝合线可利用任何合适的缝合线材料(例如尼龙、聚丙烯纤维或聚丙烯)制成。针对其生物相容性和刚度来选择近端锚固件55和近端锚固机构50的材料，以确保将装置10正确放置到左心耳内或其它治疗位置。
近端锚固机构50可包括附接到线20的附接线57。将附接线57在其近端附接到线圈20的近端轨道，并将锚固件55附接到附接线57的远端。附接线57可比线20更加柔韧或刚硬。针对其刚度或柔韧性来选择附接线的材料，以确保正确地放置装置10并使凝块的形成和移动最小。
装置10还可包括附接到线20上的片60。当线20处于其扩展线形形状时，片60可沿该线以被标记的方式延伸，以便片60的长度以与线20的纵向方向近似相同的方向延伸，如图6a的实例所示。另外，当线20处于其扩展线形形状时，片60的宽度以与线20的纵向方向近似垂直的方向延伸。当以被标记方式延伸时，片60的长度可大于片60的宽度。片60的长度可沿线20从线的近端24朝其远端22延伸。例如，线20的近端的50％或更多可由片60覆盖。片60的长度可沿线20的整个长度延伸。或者，片60的长度可沿线的近端部分延伸任何长度，该长度足以确保线20的最近端轨道其中之一或更多由片60大体上或完全遮蔽，如图6b中的实例所示，图6b显示装置10的仰视图。在另一替代实施例中，片60的长度可沿线的近端部分延伸任何长度，该长度足以确保线20的具有至少等于左心耳的开口的直径的近端轨道将大体上或完全被片60遮蔽。在图6b所示的实例中，片大体上遮蔽装置10的底部。然而，装置10可布置成片60完全遮蔽装置10的底部。
当线20处于其松驰的线圈形状时，片60将覆盖线圈20的近端轨道其中一个或多个，以便在沿线圈20的纵轴线观察装置10时，由线圈20的一近端轨道或线圈20的一内部截面限定的开口大体上或完全被片60遮蔽。或者，当线20处于其松驰的线圈形状时，片60可覆盖线20的近端轨道，以便线圈形状的内部截面通过片60的重叠被遮蔽。片60可包括在装置10的近端线轨道26上，以有效地密封左心耳的开口。使用片60密封左心耳可有效地防止血流入左心耳及/或左心耳内可能形成的任何凝块移出左心耳并进入血流中。因此，片60有助于防止形成栓塞，栓塞通常会导致严重的心理或生理残疾或死亡。
可通过沿线20缝合将片60附接到线20上。可采用其它合适的附接方式来确保将片60正确地放置并固定到线20上。
片60可利用可渗透的或不可渗透的材料制成，以帮助防止血流入左心耳及/或凝块从左心耳移出。片60可利用织物制成，包括聚酯纤维，例如涤纶(R)。或者，片可利用另一生物相容材料制成，例如膨体聚四氟乙烯(ePTFE)、特氟隆(R)、毛毡、高尔泰克斯(R)、硅酮尿烷、金属纤维或其它聚合体。
片60可具有抗凝剂覆层或促进内皮细胞生长的覆层，以帮助防止片周围形成凝块。抗凝剂覆层可包括肝素、含白蛋白的覆层、磷酸胆碱、多聚-D、L-乳酸、前列腺素、硫酸葡聚糖或其它适用用于防止凝结的肽。促进内皮生长的覆层可包括热解碳、基于冷凝蛋白质的覆层、自体纤维素网格、基于弹性蛋白的多肽、纤连蛋白、胶原IV、纤连蛋白-纤原IV组合、细胞外基质蛋白和肽、等离子体聚合覆层或促进内皮细胞在片上生长的其它合适材料。片覆层经选择以通过将片周围的凝块形成最小化来促进装置的目的，以当使用该装置时进一步减小栓塞的风险。
图3显示装置10的第二实施例。第二实施例大体上与第一实施例相同，不同之处在于，远端锚固机构30具有至少一个直接附接到线20上的锚固件35。在本发明的另一方面，线20可包括张拉环圈45，张拉环圈45在拉伸时沿线20的纵向方向施加力，使线20的近端24接近左心耳的开口。
图4和5显示图3中的实施例，其部署在心脏的左心耳100内。本发明包括一种封闭人或动物心脏的左心耳100以帮助防止血流入左心耳100及/或凝块移动的方法。将左心耳封堵装置10经由导管输送到左心耳。装置10以其大体上为线形的扩展形状输送。在其扩展状态下，远端锚固机构30、近端锚固机构50和片60靠着线折叠。
将装置部署成线20被导引在大体上左心耳100内在其松驰状态下形成大体上盘绕形状，包括一系列线轨道或环圈。在部署时，将远端锚固机构30附接到左心耳100的内壁的远端，并将近端锚固机构50附接到左心耳100的内壁的较接近部分，以将装置10适当地固定到位。或者，可仅利用远端锚固机构50来实现附接。可通过将远端锚固机构30的钩形锚固件35钩到左心耳100的内部的不规则小梁来实现装置的锚固。类似地，可将近端锚固机构50的钩形锚固件55附接到左心耳的内部的不规则小梁。或者，可将远端锚固件35和近端锚固件55用倒刺附接到线圈20上。可通过将倒刺插入左心耳100的壁并将倒刺钩在组织上来完成装置的附接。在另一替代附接方法中，锚固件可利用缝合线制成，通过将远端锚固机构30和近端锚固机构50缝合到左心耳的内壁来完成附接。
在部署装置10后，线圈的一些近端线轨道可延伸超过左心耳的开口并进入左心房。近端轨道经尺寸确定为使其直径大于大体上所有患者的左心耳100的开口的直径，以确保适当地确定装置的尺寸，从而最大程度地减小在每一患者内进行测量的需求并减少适当植入装置所需的时间。例如，可基于诊断试验(例如血管造影术)的结果来选择预定尺寸及/或形状的装置10。线圈20的近端轨道26可与房壁齐平且片60将遮蔽线20的近端轨道26，以确保片60完全遮蔽左心耳100的开口，以便适当地使凝块的移动最小化。所附接的远端锚固机构30和延伸超过左心耳100的开口的近端轨道26之间的张拉可使近端轨道与左心房的壁保持齐平以确保片60完全遮蔽开口，且继续与左房壁齐平以确保完全防止或大体上完全防止血流入左心耳100及/或凝块移入或移出左心耳100。
或者，线圈20的近端线轨道26可处于左心耳100的开口内且与左心耳100的壁的近端部分齐平。片60可遮蔽与左心耳100的壁齐平的近端线轨道，以便防止或大体上防止血流入左心耳100及/或血凝块移入左心耳100或移出左心耳100并进入血流。
上文给出了本发明的揭示内容，所属领域的技术人员将了解，在本发明的范围和精神内可存在其它的实施例和修改。相应地，所属领域的技术人员可在本发明范围和精神内根据本发明揭示内容获得的所有修改均将被含纳为本发明的其它实施例。本发明的范围如随附权利要求书中所述。

Claims (14)

1.一种左心耳封堵装置，其包括：
具有近端和远端的可变形的线，所述可变形的线形成第一预定扩展形状和第二预定松驰形状；
远端锚固件，其附接到所述可变形的线的远端并且构造成将所述装置附接到左心耳的内壁；以及
附接到所述可变形的线的近端的片；
其中，所述第一预定扩展形状是大体线性的；
其中，所述第二预定松驰形状是大体圆锥形；所述第二预定松驰形状包括连接所述近端和远端的多个轨道；所述第二预定松驰形状的直径从所述近端到所述远端减小；当所述可变形的线形成所述第二预定松驰形状时，所述片大体上覆盖在沿所述可变形的线的纵轴线观察所述可变形的线时可见的开口；并且所述开口由处于所述近端的环圈限定；
其中，当所述可变形的线形成所述第一预定扩展形状时：
(i)所述片的长度大体上大于所述片的宽度，其中，所述片的所述长度以与所述可变形的线的纵向方向大约相同的方向延伸，并且，
(ii)所述宽度以与所述可变形的线的所述纵向方向大约垂直的方向延伸。
2.如权利要求1所述的装置，其特征在于，所述可变形的线由形状记忆合金制成，所述形状记忆合金包括镍钛诺。
3.如权利要求1所述的装置，其特征在于，所述远端锚固件由第二线附接到所述可变形的线的远端。
4.如权利要求1所述的装置，其特征在于，所述片以被标记的方式远离所述可变形的线延伸。
5.如权利要求1所述的装置，其特征在于，所述片在小于所述可变形的线的长度的大约1/2的长度上贴近所述可变形的线延伸。
6.如权利要求1所述的装置，其特征在于，所述片覆有材料以防止凝结。
7.如权利要求6所述的装置，其特征在于，所述材料是肽。
8.如权利要求1所述的装置，其特征在于，所述片覆有促进内皮细胞生长的材料。
9.如权利要求1所述的装置，其特征在于，所述远端锚固件是弯钩。
10.如权利要求1所述的装置，其特征在于，所述远端锚固件包含用于附接到组织的倒刺。
11.如权利要求1所述的装置，其特征在于，所述片至少覆盖所述可变形的线的形成两个最近端环圈的部分。
12.如权利要求1所述的装置，其特征在于还包括附接到所述可变形的线的近端的近端锚固件。
13.如权利要求12所述的装置，其特征在于，所述近端锚固件包括弯钩、倒刺或缝合线。
14.如权利要求12所述的装置，其特征在于，所述近端锚固件包括四个近端锚固件。 
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