CN104203157B - 心脏瓣膜修补器械 - Google Patents

心脏瓣膜修补器械 Download PDF

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CN104203157B
CN104203157B CN201280068774.7A CN201280068774A CN104203157B CN 104203157 B CN104203157 B CN 104203157B CN 201280068774 A CN201280068774 A CN 201280068774A CN 104203157 B CN104203157 B CN 104203157B
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戴维·阿隆
卡尔-海因茨·库克
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Abstract

一种心脏瓣膜环修补器械，具有组织接合部件和多个锚定器。组织接合部件包括丝线圈。所述多个锚定器中的每一个具有尖头的前部端部以及后部端部并具有沟槽，该沟槽沿前后方向延伸。锚定器绕丝线圈分布，使多个锚定器的前部端部面对心脏瓣膜环，并且使丝线圈穿过沟槽。器械还包括植入装置，所述植入装置用来将锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。

Description

心脏瓣膜修补器械
技术领域
本发明涉及医疗器械，具体地说，涉及用来修补生物瓣膜的器械。
背景技术
二尖瓣膜位于心脏左侧中，在左心房与左心室之间。二尖瓣膜的最典型疾病是闭锁不全或心脏瓣口反流，当瓣膜小叶不适当地接合时，发生该闭锁不全或心脏瓣口反流。通过将环缝合以减小环状直径的方式的二尖瓣膜修补是校正二尖瓣心脏瓣口反流的选择过程。借助于目前的外科技术，大多数心脏瓣口反流的二尖瓣膜可利用人造瓣膜修复术修补或者更换。
目前，二尖瓣膜修补要求侵入性极大的外科手段，该外科手段包括胸骨切开术、体外循环、心动停止、以及心脏本身的切开，以暴露二尖瓣膜。这样的过程与高发病率和高死亡率相关联。经皮器械可在不需要打开心脏的手术的情况下有效地治疗疾病，该经皮器械可大大地改进病人益处，并且可以包括由于对于这样的侵入性过程太老或太虚弱而不能用手术治疗的其它病人。
用于二尖瓣膜修补的大多数目前手术实践涉及二尖瓣膜成形术(annuloplasty)和/或二尖瓣膜矫形术(valruloplasty)。
手术瓣膜成形术是一种目标在于减小在二尖瓣膜的基础处的纤维组织的尺寸的技术，该纤维组织叫做环。有时环变得增大，从而使血液能够通过两个分离的瓣膜小叶之间的间隙回流到左心房中。修补借助于缝合进行，以使开口较小，帮助两个小叶相交并且当瓣膜闭合时再次接合。
手术瓣膜矫形术是一种目标在于保证瓣膜小叶的适当闭合的技术。作为由破裂索带造成的小叶的脱垂的结果，可能损害小叶功能。小叶重建由小叶切除术进行，并且借助于缝合而改形。在大多数情况下，瓣膜成形术和瓣膜矫形术两者都需要，以便重新获得最佳二尖瓣膜功能。
由于二尖瓣膜手术的侵入性质、和在过程中涉及的高危险，许多心力衰竭病人是不良手术候选人。因而，减小二尖瓣膜心脏瓣口反流的较小侵入方法和器械可能使这种疗法适用于更多病人。
US2004/102839、US2004/1022840、US6656221、US6718985、US6723038及US2004/073302描述了对于二尖瓣膜成形术的最小侵入手段，这些最小侵入手段使用器械到左心室中或到冠状窦中的经皮***，以便减小环尺寸。
US6626930和US6575971描述了一种将瓣膜小叶的两片紧固在一起的器械和方法，改进瓣膜的能力。
US2004/243227、US2007/244554、US2008/262609、以及US2009/0287304描述了经皮器械，这些经皮器械经锚定机构附接到瓣膜环上并且接触，由此在单个步骤中减小环直径。
US2007/016286公开了一种经腔可折叠心脏瓣膜，这种经腔可折叠心脏瓣膜设计成附接到原生心脏瓣口反流的二尖瓣膜的原生环上，并且在单个步骤中更换全部。US2012/010700提供了一种用来植入修复瓣膜设备的方法，这种设备包括单向瓣膜和可展开的瓣膜座。该设备被锚定和固定在新形成的孔口中，该新形成的孔口在前瓣膜小叶的附近或中心处。
今天可以通过新开发的经皮过程替换主动脉瓣膜(位于左心室与主动脉之间的瓣膜)而不用手术。在这些过程中，将人造折叠瓣膜通过动脉输送，并且定位在患病原生瓣膜内部，然后展开以替换它。至今还没有可接受的类似过程，该可接受的类似过程可对于二尖或三尖瓣膜进行相同治疗。
在主动脉瓣膜的经皮放置成功之后，已经进行了多种尝试，以开发旨在用于二尖瓣膜的经皮治疗的类似器械，但由于如下事实：这种瓣膜环要大得多并被不定形地成形，并且不像主动脉瓣膜那样有可以起保持表面的作用的孔腔壁或钙化小叶，使得难以防止在二尖瓣膜位置中展开到位的瓣膜的移动。利用锚定特征将瓣膜附接到二尖环上对于经皮过程非常有挑战性，并且还不是非常成功。
附接到二尖环上并且然后折叠以减小其直径的器械需要非常紧密和准确地固定到组织上，以便承受为减小环直径所需的大的力。
与主动脉瓣膜的经皮手术相比，以上提到的全部器械和过程对于二尖瓣膜还没有成功。
发明内容
本发明涉及用来帮助修补生物瓣膜的器械、方法及套具，并且特别适于修补二尖、三尖及这样的瓣膜，尽管不必限于这样的实施。
按照本发明一个方面的实施例，提供有一种用来在心脏瓣膜环上执行操作的设备，该心脏瓣膜环具有原始形状，该设备包括组织接合部件，该组织接合部件包括：丝线圈，所述丝线圈构造成当丝线圈展开时与所述原始形状的至少一部分相符；和多个锚定器，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器相对于丝线圈布置成使得当丝线圈展开时，所述多个锚定器绕丝线圈分布，并且多个锚定器的前部端部面对心脏瓣膜环，且丝线圈穿过在多个锚定器中的沟槽。该设备还包括用来将所述多个锚定器植入到心脏瓣膜环组织中的装置，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，所述丝线圈包括封闭的圈。在一些实施例中，所述原始形状的至少一部分包括原始形状的至少270°的部分。在一些实施例中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取。在一些实施例中，在所述多个锚定器的每一个中，沟槽的后部端部加大，以形成孔眼。在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
在一些实施例中，组织接合部件还包括多根管，这些管在多个锚定器之间穿在丝线圈上，其中，管的外表面包括促进组织生长的材料。在一些实施例中，组织接合部件还包括第二丝线圈，该第二丝线圈穿过所述多根管的内部，并且其中，第二丝线圈包括封闭的圈。
在一些实施例中，第二丝线圈的至少一部分由抑制组织生长的材料围绕。在一些实施例中，所述多个锚定器包括至少六个锚定器。
在一些实施例中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。在一些实施例中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，所述丝线圈包括封闭的圈，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，并且其中，所述多个锚定器包括至少六个锚定器。在一些实施例中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。在一些实施例中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，该设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与心脏瓣膜环相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到心脏瓣膜环组织中。
在一些实施例中，该心脏瓣膜环是二尖瓣膜环，并且设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心房中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与二尖瓣膜环的上表面相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到二尖瓣膜环中，其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向二尖瓣膜环的上表面推压。
在一些实施例中，该设备还包括气球，该气球构造成在泄气状态下经由导管输送，并且构造成在气球的至少部分定位在左心室中时充气，并且其中，导管构造成在植入所述多个锚定器之前将气球朝二尖瓣膜环牵拉。
在一些实施例中，该设备还包括气球，该气球构造成在泄气状态下经由导管输送，其中，当将气球充气时，气球将组织接合部件引导到用于植入到二尖瓣膜环中的位置中。
按照本发明另一个方面的实施例，提供有一种用来在心脏瓣膜环上执行操作的方法，该心脏瓣膜环具有原始形状。该方法包括如下步骤：将丝线圈输送到心脏瓣膜环的附近，从而丝线圈与所述原始形状的至少一部分相符；将多个锚定器输送到心脏瓣膜环的附近，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器绕丝线圈分布，并且多个锚定器的前部端部面对心脏瓣膜环，且丝线圈穿过在多个锚定器中的沟槽；以及将所述多个锚定器植入到心脏瓣膜环中。
在一些实施例中，所述丝线圈包括封闭的圈。在一些实施例中，所述原始形状的至少一部分包括原始形状的至少270°的部分。在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入步骤期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
在一些实施例中，该方法还包括将多根管输送到心脏瓣膜环的附近的步骤，其中，所述多根管在所述多个锚定器之间穿在丝线圈上，并且其中，管的外表面包括促进组织生长的材料。
在一些实施例中，该方法还包括将第二丝线圈输送到心脏瓣膜环的附近的步骤，该第二丝线圈穿过所述多根管的内部，其中，第二丝线圈包括封闭的圈。在一些实施例中，所述多个锚定器包括至少六个锚定器。
在一些实施例中，植入步骤包括使用多个弹簧将所述多个锚定器驱动到心脏瓣膜环中。在一些实施例中，植入步骤包括使用多根拉线将所述多个锚定器驱动到心脏瓣膜环中。在一些实施例中，该心脏瓣膜环是二尖瓣膜环，并且方法还包括将所述多个锚定器朝向二尖瓣膜环的上表面按压的按压步骤，其中，按压步骤在植入步骤之前并且在输送丝线圈和输送所述多个锚定器的步骤之后实施。
在一些实施例中，该方法还包括将至少部分地布置在左心室中的充气气球朝向二尖瓣膜环牵拉的牵拉步骤，其中，牵拉步骤和按压步骤同时地进行。在一些实施例中，该方法还包括将气球充气的步骤，以将锚定器引导到用于植入到二尖瓣膜环中的位置中。
按照本发明另一个方面的实施例，提供有一种用来在二尖瓣膜上执行操作的设备，该设备包括组织接合部件，该组织接合部件包括：丝线圈，所述丝线圈构造成当丝线圈展开时接触二尖瓣膜的小叶，其中，所述丝线圈包括封闭的圈；和多个锚定器，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到小叶中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从小叶中抽取，其中，所述多个锚定器相对于丝线圈布置成使得当丝线圈展开时，所述多个锚定器绕丝线圈分布，并且所述多个锚定器的前部端部面对小叶，且丝线圈穿过位于所述多个锚定器中的沟槽。该设备还包括用来将所述多个锚定器植入到小叶中的装置，从而组织接合部件附连到小叶。
在一些实施例中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从小叶中抽取。在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的前部端部与锚定器的后部端部之间的大约半路结束，并且在植入期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
在一些实施例中，所述多个锚定器包括至少六个锚定器。在一些实施例中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到小叶中，从而组织接合部件附连到小叶。
在一些实施例中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到小叶中，从而组织接合部件附连到小叶。
在一些实施例中，该设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中。
在一些实施例中，该设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心室中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中，其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向小叶推压。
在一些实施例中，该设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心室中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中，其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向小叶牵拉。
按照本发明另一个方面的实施例，提供有一种用来在二尖瓣膜上执行操作的方法，该方法包括如下步骤：将丝线圈输送到二尖瓣膜的小叶的附近，其中，所述丝线圈包括封闭的圈；将多个锚定器输送到小叶的附近，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到小叶中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从小叶中抽取，其中，所述多个锚定器绕丝线圈分布，并且所述多个锚定器的前部端部面对小叶，且丝线圈穿过位于所述多个锚定器中的沟槽；以及将所述多个锚定器植入到小叶中。
在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的前部端部与锚定器的后部端部之间的大约半路结束，并且其中，在植入步骤期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
在一些实施例中，所述多个锚定器包括至少六个锚定器。在一些实施例中，植入步骤包括使用多个弹簧将所述多个锚定器驱动到小叶中。在一些实施例中，植入步骤包括使用多根拉线将所述多个锚定器驱动到小叶中。
在一些实施例中，该方法还包括将所述多个锚定器朝向小叶按压的步骤，其中，按压步骤在植入步骤之前并且在输送丝线圈和输送所述多个锚定器的步骤之后实施。
按照本发明另一个方面的实施例，提供有一种用来捆紧心脏瓣膜环的设备，该心脏瓣膜环具有原始形状，该设备包括组织接合部件，该组织接合部件包括：第一丝线圈，该第一丝线圈构造成当第一丝线圈展开时，与所述原始形状的至少一部分相符；多个锚定器，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器相对于第一丝线圈布置成使得当第一丝线圈展开时，所述多个锚定器绕第一丝线圈分布，并且所述多个锚定器的前部端部面对心脏瓣膜环，且第一丝线圈穿过位于所述多个锚定器中的沟槽；多根管，所述多根管在所述多个锚定器之间穿在第一丝线圈上，其中，管的外表面包括促进组织生长的材料；以及第二丝线圈，该第二丝线圈穿过所述多根管的内部，第二丝线圈具有两个端部，这两个端部构造成使得当组织接合部件附连到心脏瓣膜环时，牵拉这两个端部将捆紧心脏瓣膜环，该设备还包括用来将所述多个锚定器植入到心脏瓣膜环组织中的装置，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，第二丝线圈的至少一部分由抑制组织生长的材料围绕。在一些实施例中，所述原始形状的至少一部分包括原始形状的至少270°的部分。在一些实施例中，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取。在一些实施例中，在所述多个锚定器的每一个中，沟槽的后部端部加大，以形成孔眼。在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入期间，当沟槽的端部遇到第一丝线圈时，所述多个锚定器的向前运动受到限制。
在一些实施例中，所述多个锚定器包括至少六个锚定器。在一些实施例中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。在一些实施例中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器包括至少六个锚定器，并且其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。在一些实施例中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器包括至少六个锚定器，并且其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，从而组织接合部件附连到心脏瓣膜环。
在一些实施例中，该设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与心脏瓣膜环相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到心脏瓣膜环组织中。
在一些实施例中，该心脏瓣膜环是二尖瓣膜环，并且设备还包括：导管，所述导管具有远侧端部；和架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心房中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与二尖瓣膜环的上表面相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到二尖瓣膜环中，其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向二尖瓣膜环的上表面推压。
在一些实施例中，该设备还包括气球，该气球构造成在泄气状态下经由导管输送，并且构造成在气球的至少部分定位在左心室中时充气，并且其中，导管构造成在植入所述多个锚定器之前将气球朝二尖瓣膜环牵拉。
在一些实施例中，该设备还包括气球，该气球构造成在泄气状态下经由导管输送，其中，当将气球充气时，气球将组织接合部件引导到用于植入到二尖瓣膜环中的位置中。
按照本发明另一个方面的实施例，提供有一种用来捆紧心脏瓣膜环的方法，该心脏瓣膜环具有原始形状。该方法包括如下步骤：将第一丝线圈输送到心脏瓣膜环的附近，从而第一丝线圈与所述原始形状的至少一部分相符；将多个锚定器输送到心脏瓣膜环的附近，所述多个锚定器中的每一个具有尖头的前部端部以及后部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器绕第一丝线圈分布，并且所述多个锚定器的前部端部面对心脏瓣膜环，且第一丝线圈穿过位于所述多个锚定器中的沟槽；将多根管输送到心脏瓣膜环的附近，其中，所述多根管在所述多个锚定器之间穿在第一丝线圈上，并且其中，管的外表面包括促进组织生长的材料；将第二丝线圈输送到心脏瓣膜环的附近，其中，第二丝线圈穿过所述多根管的内部，并且具有第一端部和第二端部；将所述多个锚定器植入到心脏瓣膜环组织中；以及通过在第一端部和第二端部上牵拉，捆紧第二丝线圈。
在一些实施例中，所述原始形状的至少一部分包括原始形状的至少270°的部分。在一些实施例中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入步骤期间，当沟槽的端部遇到第一丝线圈时，所述多个锚定器的向前运动受到限制。在一些实施例中，所述多个锚定器包括至少六个锚定器。
在一些实施例中，植入步骤包括使用多个弹簧将所述多个锚定器驱动到心脏瓣膜环中。在一些实施例中，植入步骤包括使用多根拉线将所述多个锚定器驱动到心脏瓣膜环中。
在一些实施例中，该心脏瓣膜环是二尖瓣膜环，并且方法还包括将所述多个锚定器朝向二尖瓣膜环的上表面按压的按压步骤，其中，按压步骤在植入步骤之前并且在输送第一丝线圈和输送所述多个锚定器的步骤之后实施。
在一些实施例中，该方法还包括将至少部分地布置在左心室中的充气气球朝向二尖瓣膜环牵拉的牵拉步骤，其中，牵拉步骤和按压步骤同时地进行。
在一些实施例中，该方法还包括将气球充气的步骤，以将锚定器引导到用于植入到二尖瓣膜环中的位置中。
附图说明
本发明由结合附图所做的如下详细描述将更充分地理解和认识，在这些附图中：
图1是本发明的心脏瓣膜修补器械的实施例的前视部分剖视图；
图2是图1的器械的放大立体图；
图3是本器械的植入或组织接合部件的立体图；
图4-6是图1的器械的锚定器投放机构的立体图；
图7和7a是本器械的锚定器的立体图；
图8-10是组织接合部件的另一个实施例的立体图；
图11和12是用于本器械的示例性输送***的立体图；
图13是心脏的前视部分剖视图，其中植入件从瓣膜上方附连到二尖瓣膜上；
图14是器械的捆紧机构的立体图；
图15-17是锚定器的另外实施例的立体图；
图18和19是锚定器投放机构的实施例的立体图；
图20-22是心脏的前视部分剖视图，植入件从瓣膜下方附连到二尖瓣膜上；
图23-27和27a是锚定器投放机构的进一步实施例的立体图；
图29-34是植入展开机构的立体图；
图35-39是立体图，示出了与可植入器械一起使用的器械；
图40是心脏的立体部分剖视图，植入件展开以用在三尖瓣膜上；
图41是心脏的立体部分剖视图，植入件经左心房壁而展开；
图42是视图，示出了在组织愈合之后器械的人工捆紧；以及
图43是心脏的立体部分剖视图，示出了在组织愈合之后器械的机械捆紧。
本发明的实施例的如下详细描述涉及以上提到的附图。在附图中表示的元件和特征的尺寸为了方便或为了显示清楚而挑选，并且不一定按比例表示。在任何可能的地方，相同附图标记将贯穿附图和如下描述使用，以表示相同或相似部件。
具体实施方式
包括植入和输送***的一种心脏瓣膜修补器械按四个依次阶段输送到心脏中：在第一阶段中，植入和支撑架子以在囊状件内部的折叠构造穿过血管***前进到瓣膜环(优选地二尖环但也能是三尖环)。在第二阶段中，在将囊状件定位得靠近环之后，将支撑架子推到囊状件外面，并且将附接到架子上的植入件按3种选择性方式在瓣膜环上伸展成圆形或D形周向环，所述3种选择性方式为：
1)在瓣膜的流入侧上，使附接锚定器从心房侧指向心室侧；
2)在瓣膜的流入侧上，使附接锚定器从心室侧指向心房侧；以及
3)在瓣膜的流出侧上，使附接锚定器从心室侧指向心房侧。
在第三阶段中，在植入件伸开之后，将全部锚定器一次或按顺序方式都投放到组织中，并且将植入件附连到组织上。同一操作也将植入件从支撑架子和输送***分离。在第四阶段中，使架子收缩和折叠回输送囊状件中，并且将输送***从身体中退出。
重要的是要注意，在一些实施例中，伸展植入件至少部分地与瓣膜环形状相符，并且在一些实施例中，伸展植入件并不与瓣膜环形状相符，而是仅仅附连到瓣膜小叶上，并且在那里保持几分钟，直到瓣膜假体展开到其中，如以后将描述的那样。
在将植入件附接到瓣膜组织上之后，可以按5种选择性方式治疗瓣膜闭锁不全：
1)通过直接瓣膜成形术，该直接瓣膜成形术将附接到瓣膜环上的植入件强加捆紧，所以减小环直径并改进瓣膜小叶接合；
2)通过限制随着时间的推移的环形扩张，这是由于附接到瓣膜环上并且随着时间的推移通过组织生长而嵌入到组织中的植入件的恒定周界；
3)通过在附接到瓣膜环上的植入件随着时间的推移通过组织生长而嵌入到组织中之后的随后过程中促进待被植入用于瓣膜假体的支撑环；
4)通过在附接到瓣膜环上的植入件随着时间的推移通过组织生长而嵌入到组织中之后的数周或数月以后的不同过程中的随后阶段中，进行瓣膜成形术；以及
5)通过促进用于瓣膜假体的支撑环，该瓣膜假体正好在环附接到瓣膜小叶上之后的同一过程期间可植入到环中。
下面描述本发明的说明性实施例。为了清楚起见，不必描述实际装置的全部特征/元件。
图1表示本发明的二尖瓣膜调整/修补植入件10的实施例，该二尖瓣膜调整/修补植入件10植入到生物瓣膜上，该生物瓣膜由心脏的二尖瓣膜M举例说明。植入件10包括：组织接合部件12，组织接合部件12包括丝线圈14和与圈相关联并且具有细长沟槽17的多个组织锚定器16(图5)；架子或植入件***械18，在这个实施例中包括多个支撑臂20；以及锚定器投放机构22(图2-7)。植入件10经输送导管C典型地定位在二尖瓣膜M的附近。丝线圈14优选地由金属丝制成，但在可选择实施例中，丝线可以是非金属材料。注意，如这里使用的那样，“丝线”包括金属和/或非金属材料。
图2表示图1的器械的放大图，分别示出了在准备展开(投放)和已展开状态下的锚定器投放机构22；锚定器16的细长沟槽17允许圈14由锚定器保持(可操作地附接到锚定器上)，这在下文进一步描述。图3表示植入件10在其当植入时的构造中的实施例，如下面将进一步讨论的那样。
图4-6表示锚定器投放机构22的细节，该锚定器投放机构22包括：壳体24，典型地是圆柱形的；锚定器投放偏压机构，如布置在壳体内的螺旋弹簧26；以及弹簧致动器丝线28，弹簧致动器丝线28具有弯曲远侧端部29，弯曲远侧端部29穿过细长沟槽17并且穿过壳体24的窗口30突出。弯曲远侧端部29将弹簧26保持在压缩构造中。致动器丝线28纵向/轴向穿过螺旋弹簧26。植入件支撑臂20例如通过焊接分别附接到壳体24上。应该注意，致动器丝线28可由任何适当材料制成，并且不限于金属。
壳体24具有敞开端部32和弹簧保持端部34，该弹簧保持端部34在一些实施例中包括卷曲部分36或其它这样的弹簧保持机构，以便为弹簧26提供投放基座。在一些实施例中，为了防止弹簧26从壳体24弹出(落出)，弹簧具有带钩的近侧端部38，该带钩的近侧端部38适于钩在壳体的弹簧保持端部34处。如可看到的那样，圈14穿过组织锚定器16的每个细长沟槽17。如在图4中最清楚看到的那样，在一些实施例中，壳体24在敞开端部32处具有一对细长凹口40，圈14可借助于细长凹口通过。图4和5表示在投放前状态下的锚定器16，其中弹簧26被压缩，并且图6表示在投放状态下的锚定器，其中弹簧在其正常伸展构造中。
如表示的那样，组织锚定器16典型地全部沿圈14间隔开，并且圈14穿过细长沟槽17，从而允许组织锚定器运动(被投放)，典型地相对于圈或多或少地垂直(尽管在一些实施例中成角度)。应该注意，圈14可由任何适当材料制成，并且不限于金属。注意，尽管在全部示出的实施例中描绘八个锚定器，但锚定器的数量可变化。优选地使用至少六个锚定器。
参照图7，在一些实施例中，每个锚定器16具有近侧部分42，该近侧部分42包括弹簧邻接部分，该弹簧邻接部分由一对平的肩部44举例说明。锚定器16还具有尖头前部端部46，该尖头前部端部46典型地具有一个或多个倒刺48。在向前方向上植入锚定器之后，倒刺48阻止锚定器16在向后方向上的抽取。在一些实施例中，细长沟槽17具有与近侧部分42相邻的比较大的或球形的敞开部分或孔眼50，该比较大的或球形敞开部分或孔眼50可以用于为与圈14一起穿过细长沟槽的弯曲远侧端部29提供另外的空间。
图8-10表示植入件的改型，其中，圈14具有多根组织生长促进管52，这些组织生长促进管52在锚定器位置之间同轴地围绕圈。在一些实施例中，组织生长促进管52具有相应的组织生长抑制衬里或表面54(图10)。组织生长促进管52由适于促进和有利于组织在其上生长的材料和/或物质制成，例如由适当织物或涂层制成。如果的确呈衬里的形式，则组织生长抑制衬里54与组织生长促进管52例如同轴地布置，并且包括组织生长抑制材料和/或物质。
图9和10另外表示另一个实施例，其中，有两个圈-以上提到的圈14和比较坚固的辅助圈56，以将另外的坚固性提供给植入件，如果这样希望的话。图10示出了改型，其中，辅助圈还包括近侧部分58，该近侧部分58除以上提到的植入件定位装置18之外或代替植入件定位装置18，可用来定位植入件10。
操作：将植入件10经由/通过输送导管C展开到与生物瓣膜(例如二尖瓣膜M)相邻的位置(见图11和12；并且也见图1和2)。当使用支撑臂20和/或辅助圈56(该辅助圈56具有其近侧部分58)而将植入件10适当地布置时，将每个锚定器投放机构22的致动器丝线28缩回，由此使它们的弯曲远侧端部29从壳体24的相应窗口30中退出。结果，弹簧26从它们的压缩状态释放到它们的伸展状态，由此将组织锚定器16投放到生物瓣膜组织中。典型地，每个锚定器16的尖头端部46进入组织，并且倒刺48帮助防止锚定器的意外脱开。
图13示出了在组织锚定器16到组织中的投放之后连接到心脏的二尖瓣膜M的组织上的植入件10。植入件10由于按如图1所示的方式***到心脏中而定位在二尖瓣膜M的顶部上，并且锚定器16大致面朝向下。在植入之后，自然组织生长开始全部绕植入件10的在组织内的部分发生，特别是锚定器，随后组织生长也将覆盖在最接近组织表面处的植入件的部分。当组织生长填充锚定器沟槽17时，它们变得机械地锁定在组织内，并且随着时间的推移，整个植入件10将嵌在瓣膜环组织中。由于植入件主要包括由非弹性物质制成的圈14，所以防止了随着时间的推移归因于瓣膜心脏瓣口反流疾病的发展的进一步环扩张。
参照图14，在一些实施例中，植入件还包括捆紧机构60，例如其中，圈14不是呈封闭的圈构造，而是具有大致相邻的自由端部62和64。圈14的这种环状部分穿过锚定器16的细长沟槽17(并且在适当实施例中，穿过组织生长促进管52)，如以前那样。在足够的组织生长在植入件10上之后，这依据组织生长速率典型地用一周到几个月，植入件可以经由在自由端部62和/或64的一端或者两端上牵拉而捆紧，以减小组织接合部件12的直径，(然而，在操作的一些执行中，捆紧动作是不需要的，并且可从过程中排除)。自由端部62和64可以延伸到病人身体外面，或者在胸部的上部部分处保持在皮肤下面，更像起博器引导。组织生长使植入件10嵌到瓣膜环上并且与其成整体。另外，在细长沟槽17内的组织生长帮助固定锚定器16，并且防止植入件移离瓣膜环。
与在以上图中示出的圆形或椭圆形圈不同，图14还示出了D形圈14。D形圈14特别适于与人类二尖心脏瓣膜一起使用。在这方面，应该理解，圈14可通过选择或设计而构造，以与所需修补的特定生物瓣膜适当地相对应。
图15表示另一个实施例，其中，取代锚定器16经由细长沟槽17接合圈14，锚定器穿过同轴地围绕圈的同轴管66-该管可例如是组织生长促进管，如组织生长促进管52。锚定器16与同轴管66的保持由在锚定器的近侧端部处的保持钩68帮助。
图16和17描绘了实施例，其中，锚定器16具有与壳体24相类似的圆柱形形状，并且不需要这样的壳体。在这种情况下，弹簧26在圆柱形锚定器16的端部34与弹簧投放基座之间保持压缩，该弹簧投放基座由投放基座环70举例说明，该弹簧投放基座附接到植入件支撑臂20上。端部34现在提供上述平的肩部44的功能；并且投放基座环提供上述卷曲部分36的功能。当使致动器丝线28缩回时，其弯曲的远侧端部29(这里，以半圈的形式示出)从窗口30缩回，由此释放圆柱形锚定器16，从而弹簧26伸展以投放锚定器。
图18和19表示在作必要的修改后构造的植入件定位装置18，其中，锚定器投放机构22适于在大致向上方向上将锚定器16投放到组织中(即从心室侧到心房侧)。这个实施例在其中组织接合部件12用作支撑件以防止瓣膜假体的移动的情况下特别有用，该瓣膜假体正好在组织接合部件12已经展开之后可伸展到其中。
图20-24示出了实施例，这些实施例适用于其中向上投放锚定器16也可以用在如下情况下的情形：其中，对于闭锁不全瓣膜的接近是从下面(例如经由顶点(见图20))是优选的，而不是从上方。图20和22示出了圈14，该圈14布置在二尖瓣膜小叶下方，并且图21表示当锚定器16穿透小叶从心室侧指向心房侧时而布置在二尖瓣膜小叶M上的圈14。
图23和24表示用于锚定器16的向上投放的投放前和投放情形。图23还示出了导管C可用来帮助定向壳体24的角度，并因而定向锚定器16的投放角度。如果在导管C与圈14之间的距离比较小，则锚定器16往往以较大角度定位和投放(相对于与圈14垂直地投放，例如如图2和3所示)。投放角度的调整(即锚定器角度的枢转)通过支撑臂20的形状使得是可能的，壳体24附接到这些支撑臂20上。图24也示出了另一种改型，其中，锚定器16包括多个倒刺48，并且其中，细长沟槽17在锚定器的长度内大约半路地延伸。
图25-27和27a示出了具体实施例，其中，锚定器投放机构22适于与组织锚定器16一起使用，并且可通过直接牵拉或由从瓣膜区域移除的机构而致动，这些组织锚定器16在大致向上方向上投放。锚定器投放机构22包括致动丝线28和壳体24，然而机构不包括在壳体中布置的弹簧26。无论如何，为了快速致动目的(锚定器投放)，锚定器投放机构22还可以例如在导管C的近侧端部处包括外部投放致动器装置，典型地包括弹簧(未示出)，以在致动丝线28上牵拉。当导管从瓣膜的流入侧接近并将锚定器定路线从而它们在瓣膜下面，并且末端从心室侧指向心房侧时，对于瓣膜的这种构造和手段容许使用拉线。
为了这些实施例的目的，锚定器16可以修改成还包括致动丝线孔眼72，致动丝线28穿过致动丝线孔眼72。致动丝线28的远侧端部29穿过孔眼72，并且典型地具有钩状构造，同时布置在壳体24内(图25和27)。在致动器丝线28的近侧端部上牵拉，以便由于在孔眼72处牵拉而牵拉(投放)锚定器16(图26)。在这样的实施例中，壳体24不必包括诸如窗口30之类的窗口，也不必包括卷曲部分36或其它这样的弹簧保持机构，因为在壳体中没有弹簧。图27和27a示出了改型，其中，代替孔眼72；每个锚定器16具有致动器丝线远侧端部接收部分，如凹口74，该凹口74操作以便按与以上提到的相同方式投放锚定器16。
图28-30示出了实施例，其中，植入件10还包括圈-布置/锚定器-定向机构76，该圈-布置/锚定器-定向机构76对于布置圈14的位置和/或形状并且/或者对于定向壳体24的角度是有用的，并由此定向组织锚定器16的投放角度。锚定器定向机构76包括多条弯曲布置引线78，这些弯曲布置引线78分别附接到壳体24的至少一些上，例如通过焊接。引线78可以是植入件支撑臂20的延伸，并且可以布置成在单个相交点80处交叉。引线78附接(例如通过焊接)到壳体24上。因而，定向机构76的引线78是可移动的，以将圈14布置在希望位置中，并且依据引线的形状，可确定壳体24的角度，并因而确定锚定器16的角度。
关于锚定器16的投放角度，在一些实施例中，引线78可“尤其”在***到病人体中之前附接，由此依据附接位置，布置引线78也用来定向锚定器16，即控制锚定器进入组织的角度(即，改变一条或多条引线78的长度或形状因而将改变锚定器的角度，例如缩短该长度将使锚定器向外指，而增加该长度将把相交点80带到离圈14较远，并因而使锚定器倾斜成彼此更平行(较少向外)。在这样的情况下，引线78将不焊接到壳体24上，而是将包括有“特别”连接或紧固布置(未示出)，由此引线和壳体在沿引线的多于一个位置处连接。布置/定向机构76对于布置环14的形状以及定位圈和定向锚定器角度可以是有用的。在可选择实施例中，圈布置/锚定器定向机构76具有预定形状，如***形状(图29和30)，或者适于允许其形状变化，即引线78可弯曲。
图31-34示出了实施例，其中，圈布置和/或植入件***械18包括可充气气球82。附图示出了对于如下有用的示例性气球82：a)保证支撑臂20在使植入件10展开之前完全伸展；b)保证圈14在植入之前与瓣膜环同心；以及c)有利于干涉步骤或支架，靠压该支架，以用来在植入之前将植入件***械18和植入件10按压到瓣膜环上，如在图34中示出的那样。图31示出了椭圆形气球82；图32-34示出了液滴形或球茎形气球82。
如在图34中看到的、以及对于相对于瓣膜环定向线圈14是有用的那样，气球可用来在锚定器16的投放期间将植入件***械18和植入件10固定到位。图32和33也示出了气球82可相对于圈14和植入件***械18向近侧或向远侧定位。由于气球可定位在心室内部，并被充气到比生物瓣膜环的直径大的直径，所以它可用作支架，抵靠该支架，在植入之前将***械18和植入件10按压到瓣膜环上。这将保证在锚定器投放机构22的每一个与瓣膜环之间的良好接触，并且在投放时将形成锚定器16到组织中的最佳穿透条件。此外，结合考虑生物瓣膜的尺寸，锚定器16的投放角度(即，到组织中的***)可通过使气球82充气/排气而控制。
图35-37示出了器械100(例如，替换瓣膜)如何可固定到像二尖瓣膜M或三尖瓣膜之类的原生瓣膜环或者小叶上。在这个实施例中，首先将植入件10植入并且用锚定器16固定，这些锚定器16穿透瓣膜小叶，从心室V侧指向心房A侧(下文，向上)，如在图21和/或图22中那样。然后，当器械100伸展到植入件10中时，在锚定器16与器械100之间的摩擦将器械100固定到位。由于锚定器16大致向上指，所以在心房A中的高压力帮助进一步增强植入件10对于瓣膜小叶的锚定。
示出的附图中的器械100代表任何适当商业可伸展心脏瓣膜假体，该心脏瓣膜假体可在折叠构造中穿过血管***行进，并且输送到心脏。它可以是自伸展假体或气球伸展假体或任何其它类型的伸展心脏瓣膜假体。图35还示出了示例性输送***101，该示例性输送***101可将器械100输送到心脏。
图36和37示出了植入件10如何可与器械100相关联，以便将器械固定到二尖瓣膜M(或三尖瓣膜)小叶上。在这个实施例中，植入件10和器械100优选地在最小侵入手术中经由心脏的顶点P植入，如在图20中示出的那样。如在图22中那样，首先将植入件10布置在相对于生物瓣膜(在这种情况下的二尖瓣)的适当位置处，并且然后按照这里所描述的任何适当实施例，用面向上的锚定器16固定。在将植入件10附接到瓣膜小叶上之后，使器械100如图36所示穿过输送导管(未示出)前进，并且伸展到植入件10中，如在图37中看到的那样。由于锚定器16大致向上指，所以在心室V中的高压力帮助进一步增强植入件10和器械100相对于瓣膜小叶的锚定。然而，为了这个实施例的目的，其中，植入件10构造成特别适于将诸如器械100之类的器械固定到位，每个锚定器16具有比较短的沟槽17，典型地仅沿每个锚定器的纵向尺寸大约半路地延伸，从沿锚定器的约半路到比较靠近锚定器的尖头前部端部46。
参照图38和39，当器械100布置在适当心脏(或其它生物)瓣膜中并且伸展时，在器械与锚定器16之间的接触和滑动运动将锚定器的角度从典型地近似45度(图38)(尽管取决于支撑臂20的角度)改变到如下角度：其中，锚定器彼此更平行，典型地大体平行。锚定器16的运动由圆弧A-B示出在图38中。换句话说，锚定器16在沟槽17的端部处枢转，如在图7a中那样，该端部大致在锚定器的中点84处。这种角度变化提供了在锚定器16与器械100之间的增大摩擦，由此将器械固定到位。
为了进一步解释，器械100在生物瓣膜中伸展，直到器械压在锚定器16的无沟槽部分86上。由于按压在无沟槽部分86上，迫使该部分向上，并因而随着锚定器绕圈14枢转，锚定器46的末端向内运动。由于锚定器末端46锁定在瓣膜小叶的组织内，所以末端的向内运动将小叶牵拉得更靠近器械100，并且使小叶压靠器械，由此增强密封并防止在原生瓣膜小叶与器械之间的血液流动。应该理解，器械100设置成适当的尺寸以便上述定位。
图40示出了在三尖心脏瓣膜T中植入件10的展开，并且应该理解，在图1至39中所示出的植入和输送***的全部特征和功能可应用于三尖瓣膜。
图41示出了植入件10穿过左心房壁的展开，而不是穿过血管***行进或者使植入件穿过心脏的顶点展开。同样，应该理解，在图1至39中示出的植入和输送***的全部特征和功能可应用于穿过心房壁的展开。
图42示出了在组织愈合已经发生之后的随后过程中的器械的手动捆紧，如以上参照图14描述的那样。
图43示出了在组织愈合已经发生之后的随后过程中的器械的捆紧，如以上参照图14描述的那样。使用机械致动器110，该机械致动器110在过程期间植入。机械致动器可磁性地、电气地或由来自身体外面的任何其它适当机构致动。
应该理解，以上描述仅仅是示例性的，并且具有本发明的在作必要的修改之后可以想出的各种实施例，在上述实施例中描述的特征、和在这里未描述的特征可以单独地或按任何适当组合使用；并且本发明可按照不一定在以上描述的实施例而想出。

Claims (43)

1.一种用来在心脏瓣膜环上执行操作的设备，所述心脏瓣膜环具有原始形状，该设备包括：
组织接合部件，该组织接合部件包括
丝线圈，所述丝线圈构造成当丝线圈展开时与所述原始形状的至少一部分相符，和
多个锚定器，所述多个锚定器中的每一个具有后部端部以及尖头的前部端部，所述多个锚定器中的每一个具有沟槽，该沟槽在前后方向上延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器相对于丝线圈布置成使得当丝线圈展开时，所述多个锚定器绕丝线圈分布，并且所述多个锚定器的前部端部面对心脏瓣膜环且丝线圈穿过位于所述多个锚定器中的沟槽；以及
用于植入的装置，所述用于植入的装置用来将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
2.根据权利要求1所述的设备，其中，所述丝线圈包括封闭的圈。
3.根据权利要求1所述的设备，其中，所述原始形状的至少一部分包括原始形状的至少270°的部分。
4.根据权利要求1所述的设备，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取。
5.根据权利要求1所述的设备，其中，在所述多个锚定器的每一个中，沟槽的后部端部加大，以形成孔眼。
6.根据权利要求1所述的设备，其中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
7.根据权利要求1所述的设备，其中，组织接合部件还包括多根管，这些管在所述多个锚定器之间穿在丝线圈上，其中，管的外表面包括促进组织生长的材料。
8.根据权利要求7所述的设备，其中，组织接合部件还包括第二丝线圈，该第二丝线圈穿过所述多根管的内部，并且其中，第二丝线圈包括封闭的圈。
9.根据权利要求8所述的设备，其中，第二丝线圈的至少一部分由抑制组织生长的材料围绕。
10.根据权利要求1所述的设备，其中，所述多个锚定器包括至少六个锚定器。
11.根据权利要求1所述的设备，其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
12.根据权利要求1所述的设备，其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
13.根据权利要求1所述的设备，其中，所述丝线圈包括封闭的圈，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，并且其中，所述多个锚定器包括至少六个锚定器。
14.根据权利要求13所述的设备，其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
15.根据权利要求13所述的设备，其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
16.根据权利要求1所述的设备，还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与心脏瓣膜环相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到心脏瓣膜环组织中。
17.根据权利要求1所述的设备，其中，该心脏瓣膜环是二尖瓣膜环，并且其中，该设备还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心房中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与二尖瓣膜环的上表面相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到二尖瓣膜环中，
其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向二尖瓣膜环的上表面推压。
18.根据权利要求17所述的设备，还包括气球，该气球构造成在泄气状态下经由导管输送，并且构造成在气球的至少部分定位在左心室中时充气，并且其中，导管构造成在植入所述多个锚定器之前将气球朝二尖瓣膜环牵拉。
19.根据权利要求17所述的设备，还包括气球，该气球构造成在泄气状态下经由导管输送，其中，当将气球充气时，气球将组织接合部件引导到用于植入到二尖瓣膜环中的位置中。
20.一种用来在二尖瓣膜上执行操作的设备，该设备包括：
组织接合部件，该组织接合部件包括
丝线圈，所述丝线圈构造成当丝线圈展开时接触二尖瓣膜的小叶，其中，所述丝线圈包括封闭的圈，和
多个锚定器，所述多个锚定器中的每一个具有后部端部以及尖头的前部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到小叶中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从小叶中抽取，
其中，所述多个锚定器相对于丝线圈布置成使得当丝线圈展开时，所述多个锚定器绕丝线圈分布，并且所述多个锚定器的前部端部面对小叶，且丝线圈穿过位于所述多个锚定器中的沟槽；和
用于植入的装置，所述用于植入的装置用来将所述多个锚定器植入到小叶中，使得组织接合部件附连到小叶。
21.根据权利要求20所述的设备，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从小叶中抽取。
22.根据权利要求20所述的设备，其中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的前部端部与锚定器的后部端部之间的大约半路结束，并且其中，在植入期间，当沟槽的端部遇到丝线圈时，所述多个锚定器的向前运动受到限制。
23.根据权利要求20所述的设备，其中，所述多个锚定器包括至少六个锚定器。
24.根据权利要求23所述的设备，其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到小叶中，使得组织接合部件附连到小叶。
25.根据权利要求23所述的设备，其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到小叶中，使得组织接合部件附连到小叶。
26.根据权利要求20所述的设备，还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中。
27.根据权利要求20所述的设备，其中，该设备还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心室中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中，
其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向小叶推压。
28.根据权利要求20所述的设备，其中，该设备还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心室中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与小叶相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到小叶中，
其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向小叶牵拉。
29.一种用来捆紧心脏瓣膜环的设备，该心脏瓣膜环具有原始形状，该设备包括：
组织接合部件，该组织接合部件包括
第一丝线圈，所述第一丝线圈构造成使得当第一丝线圈展开时与所述原始形状的至少一部分相符，
多个锚定器，所述多个锚定器中的每一个具有后部端部以及尖头的前部端部，所述多个锚定器中的每一个具有沟槽，该沟槽沿前后方向延伸，其中，所述多个锚定器的前部端部构造成用于沿向前方向植入到心脏瓣膜环组织中，并且其中，所述多个锚定器构造成使得在植入以后所述多个锚定器阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器相对于第一丝线圈布置成使得当第一丝线圈展开时，所述多个锚定器绕第一丝线圈分布，并且所述多个锚定器的前部端部面对心脏瓣膜环，且第一丝线圈穿过位于所述多个锚定器中的沟槽，
多根管，所述多根管在所述多个锚定器之间穿在第一丝线圈上，其中，管的外表面包括促进组织生长的材料，以及
第二丝线圈，该第二丝线圈穿过所述多根管的内部，第二丝线圈具有两个端部，这两个端部构造成使得当组织接合部件附连到心脏瓣膜环时，牵拉这两个端部将捆紧心脏瓣膜环；和
用于植入的装置，所述用于植入的装置用来将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
30.根据权利要求29所述的设备，其中，第二丝线圈的至少一部分由抑制组织生长的材料围绕。
31.根据权利要求29所述的设备，其中，所述原始形状的至少一部分包括原始形状的至少270°的部分。
32.根据权利要求29所述的设备，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取。
33.根据权利要求29所述的设备，其中，在所述多个锚定器的每一个中，沟槽的后部端部加大，以形成孔眼。
34.根据权利要求29所述的设备，其中，在所述多个锚定器的每一个中，沟槽在锚定器的前部端部附近开始，并且在锚定器的后部端部附近结束，并且其中，在植入期间，当沟槽的端部遇到第一丝线圈时，所述多个锚定器的向前运动受到限制。
35.根据权利要求29所述的设备，其中，所述多个锚定器包括至少六个锚定器。
36.根据权利要求29所述的设备，其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
37.根据权利要求29所述的设备，其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
38.根据权利要求29所述的设备，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器包括至少六个锚定器，并且其中，用于植入的装置包括多个压缩弹簧，这些压缩弹簧构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
39.根据权利要求29所述的设备，其中，所述多个锚定器中的每一个包括倒刺，在植入以后，该倒刺阻止沿向后方向从心脏瓣膜环组织中抽取，其中，所述多个锚定器包括至少六个锚定器，并且其中，用于植入的装置包括多根拉线，这些拉线构造成分别将所述多个锚定器植入到心脏瓣膜环组织中，使得组织接合部件附连到心脏瓣膜环。
40.根据权利要求29所述的设备，还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，这些支撑臂构造成将所述多个锚定器在一位置中与心脏瓣膜环相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到心脏瓣膜环组织中。
41.根据权利要求29所述的设备，其中，该心脏瓣膜环是二尖瓣膜环，并且其中，该设备还包括：
导管，所述导管具有远侧端部；和
架子，所述架子包括多个支撑臂，其中，所述架子构造成用于当导管的远侧端部定位在左心房中时展开，并且所述架子还构造成将所述多个锚定器在一位置中与二尖瓣膜环的上表面相邻地支撑到位，在该位置处，用于植入的装置能够将所述多个锚定器植入到二尖瓣膜环中，
其中，导管构造成在植入所述多个锚定器之前将所述多个锚定器朝向二尖瓣膜环的上表面推压。
42.根据权利要求41所述的设备，还包括气球，该气球构造成在泄气状态下经由导管输送，并且构造成在气球的至少部分定位在左心室中时充气，并且其中，导管构造成在植入所述多个锚定器之前将气球朝二尖瓣膜环牵拉。
43.根据权利要求41所述的设备，还包括气球，该气球构造成在泄气状态下经由导管输送，其中，当将气球充气时，气球将组织接合部件引导到用于植入到二尖瓣膜环中的位置中。
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