CN111655200B - 瓣环成形术结构的收缩 - Google Patents
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Abstract
瓣环成形术结构包括柔性套筒(25)和细长的收缩丝线(26)。套筒具有第一套筒端部(42)、第二套筒端部(44)、和在第一与第二套筒端部之间限定纵向腔(48)的周向壁(46)。收缩丝线具有第一丝线端(52)和第二丝线端(54)，第一丝线端在第一套筒端部处附接到套筒。丝线与周向壁关联，从第一套筒端部延伸到第二套筒端部。丝线相对于套筒被布置使得设置在腔内的丝线的纵向比例增加，纵向地使套筒收缩。还提供了其它实施方式。
Description
相关申请的交叉引用
本申请要求Peleg等人于2018年1月24日提交且标题为“Contraction of anannuloplastyband”的美国临时专利申请62/621,280的优先权，其通过引用并入本文。
技术领域
本发明的一些应用总体上涉及植入物的调节。例如，本发明的一些应用涉及心血管植入物(如瓣环成形术结构)的收缩。
背景技术
缺血性心脏病通过乳头肌的缺血性功能障碍和缺血性心脏病中存在的心室扩张的结合，随后发生乳头肌移位和瓣环扩张而导致房室瓣反流。
当瓣膜关闭时，房室瓣的瓣环的扩张会阻止瓣膜小叶完全接合。血液从心室到心房的反流可导致总的每搏输出量增加和心输出量减少，继而由于心房的容积超负荷和压力超负荷而使心室最终减弱。
瓣环成形术，如通过瓣环成形术环的植入，可用于通过调节房室瓣瓣环的形状来改善小叶接合。经皮(例如，经股、经间隔等)瓣环成形术装置会是有益的。
发明内容
本发明内容旨在提供一些实例，并且不意图以任何方式限制本发明的范围。例如，在本发明内容的实例中所包括的任何特征都不是权利要求所要求的，除非权利要求明确陈述了这些特征。此外，所描述的特征可以以多种方式组合。本文的描述涉及可用于重塑心脏和/或其部分的系统、组合件、方法、装置、设备、组合等。本公开中其它地方描述的各种特征和步骤可包括在此处概述实例中。
通过拉紧收缩丝线来收缩包括套筒和收缩丝线的可调节瓣环成形术带。在示例性应用中，所产生的收缩丝线的多余部分(excess)存放(deposited)在套筒的腔内，从而避免了例如通过切割从植入物中去除该多余部分的需要。因此，可以通过将收缩丝线拉入腔中和/或增加设置在腔内的收缩丝线的纵向比例来实现瓣环成形术带的收缩。可以通过将锁定机构锁定到丝线来维持收缩。
对于某些应用，收缩丝线是从腔内拉动到腔中的。对于某些应用，收缩丝线是从腔外拉动的。对于某些应用，收缩丝线是使用调节机构进给(fed)到腔中的。
因此，在示例性应用中，提供了用于对象的心脏处的系统或设备，系统/设备包括瓣环成形术带，瓣膜成形术带包括：
柔性套筒，具有第一套筒端部、第二套筒端部、和在第一套筒端部和第二套筒端部之间限定纵向腔的周向壁(circumferential wall)。
具有第一丝线端和第二丝线端的细长收缩丝线，第一丝线端在第一套筒端部处附接到套筒，并且丝线与周向壁关联(结合，association)，从第一套筒端部延伸到第二套筒端部。
丝线可相对于套筒布置，使得将收缩丝线拉入腔中和/或增加设置在腔内的丝线的纵向比例，纵向地使套筒收缩。
在一种应用中，第二丝线端设置在腔内，并且丝线相对于套筒布置，使得通过将丝线拉入腔中，第二丝线端朝向第一套筒端部的移动增加设置在腔内的丝线的纵向比例。
在一种应用中，系统/设备包括收缩工具，收缩工具包括丝线接合构件。丝线接合构件可纵向移动到腔中并且穿过腔到第二丝线端，并且可逆地可耦接(couplable)(例如，在腔内或在腔外)到第二丝线端。当耦接(联接，coupled)到第二丝线端时，丝线接合构件能够朝向第一套筒端部纵向可移动，使得第二丝线端朝向第一套筒端部移动，从而将丝线拉入腔中并纵向地使套筒收缩。
在一种应用中，通过沿着第一套筒端部和第二套筒端部之间的周向壁编织，丝线与周向壁关联，从第一套筒端部延伸到第二套筒端部。
在一种应用中，系统/设备包括单向机构，单向机构耦接到丝线，被配置以允许丝线通过单向机构单向移动，并且以这样的布置在第二套筒端部处耦接到套筒：(i)允许将丝线拉入腔中和/或增加设置在腔内的丝线的纵向比例，和(ii)阻止减小设置在腔内的丝线的纵向比例。
系统/设备可以进一步包括附接装置，如多个锚定件。在一些应用中，系统/设备包括多个锚定件，其中多个锚定件中的每个锚定件可独立地推进到腔中，并且被配置以通过经驱动穿过周向壁并进入组织中而将套筒锚定到组织。在一些应用中，系统/设备包括多个锚定件，并且多个锚定件中的每个锚定件可包括锚定件头和组织接合构件，可独立地推进到腔中，并且可被配置以通过将组织接合构件驱动穿过周向壁并进入组织中，同时锚定件头保留在腔中而使套筒锚定到组织。
系统/设备可包括收缩工具，收缩工具包括丝线接合构件，并且丝线接合构件，在使用锚定件将套筒锚定之后。收缩工具可纵向移动到腔中并穿过腔到第二丝线端，并且可逆地可耦接(例如，在腔内或在腔外)到第二丝线端。当耦接到第二丝线端时，其能够朝向第一套筒端部可纵向移动穿过腔并经过锚定件头，使得第二丝线端朝向第一套筒端部移动，从而将丝线拉入腔中并纵向地使套筒收缩。
在一种应用中，系统/设备包括锁定机构，如锁定件等。锁定机构可包括解锁状态和锁定状态：在解锁状态中，锁定机构允许丝线移动穿过锁定机构，并将丝线拉入腔中和/或增加设置在腔内的丝线的纵向比例；在锁定状态中，锁定机构阻止丝线穿过锁定机构移动。
在一种应用中，锁定机构是瓣环成形术带的部件并且耦接到套筒，并且瓣环成形术带在锁定机构耦接到套筒的情况下可经腔地(transluminally)推进到心脏。
锁定机构可以设置在腔的外部或设置在腔的内部。在一种应用中，锁定机构在第二套筒端部处耦接到套筒。
在一种应用中，设备包括收缩工具，收缩工具包括丝线接合构件。丝线接合构件可纵向移动到腔中并穿过腔到第二丝线端。丝线接合构件也能够可逆地耦接(例如，在腔内或在腔外)到第二丝线端。当耦接到第二丝线端时，丝线接合构件能够朝向第一套筒端部可纵向移动，使得第二丝线端朝向第一套筒端部移动，从而将丝线拉入腔中并纵向地使套筒收缩。
锁定机构可耦接到收缩工具，并且使用收缩工具，能够朝向第二套筒端部和丝线可纵向地推进穿过腔。
在一种应用中，设备包括接合锁定机构的锁定件工具，并且被配置以将锁定机构转变成锁定状态。锁定件工具可被配置以在腔外或腔内接合锁定机构。
在一种应用中，锁定机构被偏置以呈现(assume)锁定状态。在一种应用中，锁定件工具被配置以使锁定机构保持在解锁状态，同时锁定件工具与锁定机构接合，并且锁定件工具被配置以通过与锁定机构脱离而将锁定机构转变成锁定状态。
在一种应用中，瓣环成形术带还包括调节机构，调节机构在第二套筒端部处耦接到套筒，并且耦接到丝线。调节机构可被配置使得调节机构的致动通过将丝线进给到腔中来增加设置在腔内的丝线的纵向比例。
在一种应用中，调节机构包括绞盘。在一种应用中，调节机构被配置以在调节机构致动时不收集丝线。
在一种应用中，设备还包括引导管，引导管从调节机构延伸到腔中，调节机构的致动通过将丝线进给到该管中而将丝线进给到腔中。
在一种应用中，设备还包括设置在腔内的引导管，并且调节机构的致动将丝线进给到管中。
在示例性应用中，还提供了这样的方法，该方法包括将瓣环成形术带固定在对象的瓣膜的瓣环上。瓣环成形术带包括(i)柔性套筒，其限定穿过其中的纵向腔，和(ii)细长的收缩丝线。方法还包括随后纵向地使套筒收缩。在一种应用中，这是通过将收缩丝线拉动到腔中和/或通过将收缩丝线拉入腔中，通过增加设置在腔内的收缩丝线的纵向比例来完成的。
在一种应用中，套筒包括限定腔的周向壁，并且对于多个锚定件中的每个锚定件，将瓣环成形术带固定在瓣环上按顺序包括：将锚定件推进到腔中，并驱动锚定件的组织接合构件穿过周向壁并进入到瓣环中，使得锚定件的锚定件头保留在腔中。
在一种应用中，套筒具有第一套筒端和第二套筒端，并且收缩丝线具有第一丝线端和第二丝线端，并且纵向地使套筒收缩包括使第二丝线端更靠近第一套筒端。
在一种应用中，方法还包括，在纵向地使套筒收缩的步骤之后，通过将锁定机构锁定到收缩丝线来维持套筒的收缩状态。锁定机构可以是瓣环成形术带的部件，并且可耦接到套筒，并且具有解锁状态和锁定状态。
将瓣环成形术带固定在瓣环上可包括将瓣膜成形术带固定到瓣环上，瓣膜成形术带具有耦接到套筒的锁定机构。
在一种应用中，纵向地使套筒收缩的步骤包括，通过将收缩丝线拉到腔中和/或通过将收缩丝线拉动到腔中同时锁定机构处于解锁状态，增加设置在腔内的收缩丝线的纵向比例来纵向地使套筒收缩。
方法还可包括，在纵向地使套筒收缩之后，将锁定机构转变成其锁定状态。
在一种应用中，锁定机构耦接到套筒并且设置在腔的外部，并且将瓣环成形术带固定在瓣环上包括，使具有耦接到套筒且设置在腔外部的锁定机构的瓣环成形术带固定到瓣环。
在一种应用中，方法还包括使收缩工具的丝线接合构件纵向地推进到腔中并穿过腔，并将丝线接合构件耦接(例如，在腔内或在腔外)到丝线，并且纵向地使套筒收缩的步骤包括通过使用收缩工具将收缩丝线拉到腔中，通过增加设置在腔内的收缩丝线的纵向比例来纵向地使套筒收缩。
在一种应用中，使收缩工具的丝线接合构件推进包括，使锁定机构推进到腔中同时锁定机构耦接到收缩工具，并且将锁定机构锁定到收缩丝线包括将锁定机构锁定到腔内的收缩丝线。
在一种应用中，收缩工具包括将锁定机构维持在解锁状态的锁定件工具，并且将锁定机构锁定到收缩丝线包括，通过使锁定件工具与锁定机构脱离而允许锁定件转变成锁定状态。
在一种应用中，套筒包括限定腔的周向壁，并且对于多个锚定件中的每个锚定件，将瓣环成形术带固定在瓣环上按顺序包括：
将锚定件推进到腔中，并且
驱动锚定件的组织接合构件穿过周向壁并进入瓣环，使得锚定件的锚定件头保留在腔中，并且
将收缩工具的丝线接合构件纵向地推进到腔中并穿过腔包括，将收缩工具的丝线接合构件纵向地推进到腔中且穿过腔并经过腔内的锚定件头。
在一种应用中，将锁定机构锁定到收缩丝线包括，使用与腔外部的锁定机构接合的锁定件工具将锁定机构转变成锁定状态。
在一种应用中，将锁定机构锁定到收缩丝线包括，使锁定件工具与锁定机构脱离，锁定机构被偏置以呈现锁定状态，并且锁定件工具被配置以将锁定机构保持在解锁状态，同时锁定件工具与锁定机构接合。
在一种应用中，将收缩丝线拉动到腔中包括使收缩丝线的末端纵向移动穿过腔。
在一种应用中，使收缩丝线的末端纵向移动穿过腔包括将收缩丝线的末端纵向拉动穿过腔。
在一种应用中，将收缩丝线的末端纵向拉动穿过腔包括使用耦接到收缩丝线的末端的工具纵向拉动收缩丝线的末端穿过腔。
在一种应用中，使收缩丝线的末端纵向移动穿过腔包括纵向推动收缩丝线的末端穿过腔。
在一种应用中，瓣环成形术带还包括耦接到套筒和丝线的调节机构，并且纵向地使套筒收缩的步骤包括通过致动调节机构将收缩丝线进给到腔中。
在一种应用中，致动调节机构包括使用调节工具致动调节机构，并且方法还包括在致动调节机构之后使调节工具与调节机构脱离。
在一种应用中，方法还包括，在将瓣环成形术带固定在瓣环上之后，且在致动调节机构之前，将调节工具推进到瓣环成形术带并使调节机构与调节工具接合。
在一种应用中，调节机构包括可旋转构件，并且致动调节机构包括转动(旋转，rotate)可旋转构件。
在一种应用中，可旋转构件是绞盘，并且转动可旋转构件包括转动绞盘。
在一种应用中，致动调节机构包括致动调节机构而不将丝线收集在调节机构上。
在一种应用中，瓣环成形术带还包括从调节机构延伸到腔中的导引管，并且通过致动调节机构将收缩丝线进给到腔中包括，通过致动调节机构将收缩丝线进给到管中。
还提供了用于对象的心脏处的系统或设备，系统/设备包括瓣环成形术结构，瓣膜成形术结构包括柔性套筒，柔性套筒具有第一套筒端部、第二套筒端部、和在第一与第二套筒端部之间限定纵向腔的周向壁。瓣环成形术结构还包括具有第一丝线端和第二丝线端的细长收缩丝线，第一丝线端在第一套筒端部处附接到套筒，并且该丝线与周向壁关联，在第一套筒端部和第二套筒端部之间延伸。
系统/设备还可包括可耦接到套筒的调节机构。在一些应用中，调节机构是包括至少第一滑轮和第二滑轮的滑轮系统。但是，在一些应用中，滑轮系统可包括至少三个滑轮、至少四个滑轮、至少五个滑轮、至少六个滑轮或更多。
在一些应用中，系统/设备还可包括致动器，致动器机械地耦接到滑轮系统，使得致动器的致动调节第一滑轮和第二滑轮之间的距离。致动器可以是线性致动器。致动器可包括旋转构件，并且经由旋转构件的转动被致动。
丝线相对于套筒和调节机构被布置使得，将丝线拉动到调节机构中纵向地使套筒收缩。
在一些应用中，滑轮系统与丝线接合，使得增加第一和第二滑轮之间的距离将丝线拉动到调节机构中，从而纵向地使套筒收缩。
滑轮系统和丝线可被配置以机械地配合，使得以距离增加量来增加距离使比该距离增加量长的一部分丝线，诸如是该距离增加量的至少两倍长或更长(例如，至少四倍长、至少六倍长等)的一部分丝线拉动到调节机构中。
滑轮系统和丝线可被配置以机械地配合，使得以距离增加量来增加距离纵向地使套筒收缩大于该距离增加量的收缩长度，诸如收缩是该距离增加量的至少两倍长或更长(例如，至少四倍长、至少六倍长等)的收缩距离。
还提供了用于对象的心脏处的系统或设备，系统/设备包括具有第一部分和第二部分的植入物。植入物包括具有第一丝线端和第二丝线端的收缩丝线，第一丝线端附接到第一部分，并且丝线从第一部分延伸到第二部分。植入物还包括可耦接到收缩丝线的调节机构。
在一些应用中，调节机构包括滑轮系统，滑轮系统包括至少第一滑轮和第二滑轮。
在一些应用中，调节机构包括机械地耦接到滑轮系统的致动器，使得致动器的致动调节第一滑轮和第二滑轮之间的距离。
丝线可相对于第一部分、第二部分以及调节机构布置，使得将丝线拉入调节机构中使第一部分和第二部分更近地拉在一起。在一种应用中，丝线以往复布置方式布置在调节机构内。
滑轮系统可与丝线接合，使得增加第一和第二滑轮之间的距离使丝线拉入调节机构中，从而将第一部分和第二部分更近地拉在一起。
在一种应用中，植入物包括柔性套筒，柔性套筒具有在第一和第二部分之间限定纵向腔的周向壁。
在一种应用中，调节机构还包括容纳滑轮系统和致动器的壳体。
滑轮系统可包括任意数量的滑轮。在一种应用中，滑轮系统包括至少三个滑轮。滑轮系统也可包括至少四个滑轮或至少五个滑轮。
在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使比该距离增加量长的一部分丝线拉入调节机构中。
在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使是该距离增加量的至少两倍长的一部分丝线拉入调节机构中。在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使是该距离增加量的至少四倍长的一部分丝线拉入调节机构中。在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使是该距离增加量的至少六倍长的一部分丝线拉入调节机构中。
在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使以大于该距离增加量的收缩长度将第一部分和第二部分更近地拉在一起。
在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使以是该距离增加量的至少两倍长的收缩长度将第一部分和第二部分更近地拉在一起。在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使以是该距离增加量的至少四倍长的收缩长度将第一部分和第二部分更近地拉在一起。在一种应用中，滑轮系统和丝线机械地配合，使得以距离增加量来增加距离使以是该距离增加量的至少六倍长的收缩长度将第一部分和第二部分更近地拉在一起。
在一种应用中，第一滑轮包括第一轮，并且第二滑轮包括第二轮。在一种应用中，第一轮和第二轮是无动力的，并且被配置以响应于丝线在其上移动而被动地转动。
在一种应用中，致动器是线性致动器，并且可以是丝杠等。
在一种应用中，致动器包括旋转构件，并且经由旋转构件的转动而被致动。
在一种应用中，系统/设备还包括这样的工具，其：(i)可经腔地推进到植入物，(ii)可在体内可逆地与旋转构件接合，并且(iii)在与旋转构件接合时，被配置以使旋转构件转动。
还提供了用于对象的心脏处的系统或设备，系统/设备包括植入物。植入物包括柔性套筒，柔性套筒具有第一套筒端部、第二套筒端部、和在第一与第二套筒端部之间限定纵向腔的周向壁。植入物还可包括耦接到套筒的锁定件，锁定件包括被动绞盘。植入物包括细长的收缩丝线或其它收缩构件。
收缩丝线/构件可附接到第一套筒端部，并且可以(i)与周向壁关联，从第一套筒端部延伸到第二套筒端部，并且(ii)延伸穿过锁定件，围绕绞盘(在绞盘周围，aroundthecapstan)缠绕至少一次，并且(iii)远离锁定件和套筒延伸。
丝线与套筒之间的关联可以是这样的：经由锁定件将丝线的渐进区域拉离套筒，渐进地、纵向地使套筒收缩。
收缩丝线围绕绞盘的缠绕可以是这样的：丝线穿过锁定件的移动使绞盘转动。
锁定件可以：
具有独立的解锁状态，在该解锁状态下绞盘可旋转，从而有利于丝线穿过锁定件移动，
具有独立的锁定状态，在该锁定状态下绞盘的转动在至少一个方向上被锁定，从而防止丝线穿过锁定件移动，并且
可在解锁状态和锁定状态之间可逆地切换。
在一种应用中，锁定件向着处于锁定状态而偏置。
在一种应用中，锁定件还包括机械电阻器，机械电阻器被配置以部分地抵抗丝线穿过锁定件移动，而与锁定件是处于解锁状态还是锁定状态无关。
在一种应用中，在锁定状态下，绞盘的旋转被双向锁定。在一种应用中，在锁定状态下，绞盘的旋转被单向锁定。
在一种应用中，植入物可经腔地植入在对象的心脏中。
在一种应用中，系统/设备还包括调节工具，调节工具可经腔地推进到经腔植入的植入物。
在一种应用中，调节工具可与锁定件接合，并且被配置以将锁定件在解锁状态和锁定状态之间切换。
在一种应用中，工具还被配置以通过拉动丝线使套筒收缩。
在一种应用中，系统/设备还包括引导构件，引导构件包括柔性管，引导构件的远侧部分可逆地耦接到锁定件，丝线经由管远离锁定件和套筒延伸，并且工具通过在管上向远侧被推进到锁定件而可经腔地推进到经腔植入的植入物。
在一种应用中，锁定件还包括容纳绞盘的壳体，绞盘旋转地耦接到壳体，并且丝线穿过锁定件的移动使绞盘相对于壳体旋转。
在一种应用中，在解锁状态下，绞盘相对于壳体可双向旋转。
在一种应用中，锁定件还包括至少一个棘爪，棘爪被偏置以使绞盘相对于壳体旋转地锁定。
在一种应用中，至少一个棘爪附接到绞盘，并且被配置以通过接合壳体而使绞盘相对于壳体旋转地锁定。
在一种应用中：壳体被塑形以限定凹部(recess)，至少一个棘爪被配置以通过突出到凹部中而接合壳体，并且壳体包括按钮，当被按压时，按钮通过阻碍棘爪接合凹部而将锁定件切换到解锁状态。
在一种应用中，至少一个棘爪被偏置以将绞盘相对于壳体旋转地锁定在多个旋转位置中。
在一种应用中，至少一个棘爪是多个棘爪，多个棘爪中的每个棘爪被偏置以将绞盘相对于壳体旋转地锁定在相应的旋转位置中。
本文其它地方描述的其它特征和部件以及步骤也可与上述系统、设备和方法一起使用和/或添加到上述系统、设备和方法中。
通过下面结合附图对其应用的详细描述，将会更全面地理解本发明，其中：
附图说明
图1A-E是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图。
图2A-E是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图；
图3A-D是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图；
图4A-D是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图；
图5A-C是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图；以及
图6A-D和7A-E是用于治疗天然心脏瓣膜的示例性瓣环成形术系统的示意图。
具体实施方式
参考图1A-E，其是包括植入物22的示例性瓣环成形术系统20的示意图。系统20用于治疗对象的心脏4的天然瓣膜10(例如，房室瓣，如二尖瓣或三尖瓣)。使用系统20的本文所述述的任何和所有方法、技术、步骤等可以在活体动物或非活体尸体、尸体心脏、模拟器、拟人幻影(anthropomorphic ghost)等上执行。
植入物22包括植入物主体24，其可以是瓣环成形术结构，如瓣环成形术带或瓣环成形术环。植入物主体24包括柔性套筒25。套筒25具有第一套筒端部42、第二套筒端部44和周向壁46。周向壁46可以在例如第一和第二套筒端部之间限定纵向腔48。周向壁46可由织物制成，如聚对苯二甲酸乙二醇酯织物，例如，Dacron(TM)。植入物22还包括细长的收缩丝线或元件26。要注意的是，术语“丝线”不意图将丝线26限制为金属的，也无意于限制其可包含的股数。对于某些应用，收缩丝线包括一股或多股金属。对于某些应用，收缩丝线26包括一股或多股聚合物。对于某些应用，收缩丝线26是编织的或织造的。对于某些应用，收缩丝线26涂覆有低摩擦涂层，例如聚四氟乙烯(PTFE)。
植入物主体24可被配置以部分或完全围绕瓣膜10的瓣环放置。植入物主体24可以以多种方式附接到组织(例如，心脏瓣膜瓣环的组织等)，诸如利用锚定件、缝合线、夹子、和/或其它附接装置。在一些实施方式中，植入物主体24被配置以使用多个(例如，5-20个)组织锚定件32锚定在适当位置。在一个实施方式中，每个组织锚定件包括组织耦接构件34和紧固到组织耦接构件的末端的工具接合头36。在一些实施方式中，在将植入物主体24引入对象中后，将每个锚定件32顺序地(并且通常独立地)体内地递送到套筒的腔中，并且驱动其组织耦接构件34穿过周向壁并进入瓣膜瓣环的组织中，从而将套筒锚定到瓣膜瓣环。在附接到组织之后，植入物主体24的纵向收缩周向地拉紧瓣膜瓣环，从而改善瓣膜小叶的接合，并减少反流。
对于某些应用，植入物主体24的瓣环成形术结构是在以下出版物(其通过引用并入本文)的一个或多个中描述的瓣环成形术结构(一种或多种)，或者经过必要的修改而与其共享特征。对于某些应用，经过必要的修改，植入物22如这些出版物中的一个或多个描述的那样植入：
Zipory等人的PCT申请公开WO 2010/128503。
Gross等人的PCT申请公开WO 2012/176195。
Sheps等人的PCT申请公开WO 2013/069019。
Sheps等人的PCT申请公开WO 2014/064694。
收缩丝线26具有第一丝线端52和第二丝线端54。在一些实施方式中，第一丝线端52在第一套筒端部42处附接到(例如，固定地附接到)套筒25，并且丝线26关联套筒的周向壁从第一套筒端部延伸到第二套筒端部44。在一些实施方式中，并且如所示，通过沿第一套筒端部42和第二套筒端部44之间的周向壁编织或作为该周向壁的部分编织的丝线来提供丝线26和周向壁46之间的关联。
如所示，套筒端部42和44可包括不止套筒25的最末端(very end)。类似地，丝线26可以不一直延伸到套筒25的末端。如所示，可以将至少一个锚定件32放置在套筒端部42和44中的至少一个内，超过丝线26。
如下文中更详细地描述的，丝线26相对于套筒25被布置使得将纵向比例的丝线拉入腔中和/或增加设置在腔内的量，纵向地使套筒收缩。任选地，丝线26的末端54可以位于腔内部。
图1A示意性地显示了在将其于瓣膜10处植入之后的植入物22，其中每个锚定件32的组织耦接构件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环中。为了清楚起见，未显示组织耦接构件34穿入的组织。如所示，第二丝线端54可以在植入之前和/或植入期间设置在套筒25的腔内，或者可以设置在腔外部但是可拉入腔中。对于某些应用，并且如所示，系统20还包括细长的引导构件28，细长的引导构件28可逆地耦接到第二丝线端54，并且向近侧延伸穿过套筒25的腔，并向近侧远离植入物22(例如，从对象中离开)。
在将植入物22植入后，使用收缩工具60来促进植入物的收缩。收缩工具60包括丝线接合构件62，丝线接合构件62可纵向移动到腔48中，并穿过腔到达第二丝线端54。这种移动在图1B中显示。对于使用锚定件32来锚定植入物主体24的应用，工具60被设定尺寸以能够穿过腔48推进经过已经设置在腔内的锚定件头36。
丝线接合构件62例如在腔48内能够可逆地耦接到第二丝线端54。这种耦接在图1C中显示。植入物22可包括耦接到收缩丝线26的第二丝线端54的附件(appendage)55，丝线接合构件62和附件55被相互地配置以便于将丝线接合构件可逆地耦接到收缩丝线的第二丝线端。当耦接到第二丝线端54时，丝线接合构件62可朝向第一套筒端部42纵向移动(例如，通过向近侧拉动)，使得第二丝线端朝向第一套筒端部移动，从而将收缩丝线26拉入腔48中，并使套筒25纵向地收缩(图1D)。
系统20还包括锁定机构70，锁定机构70耦接到收缩工具60，并且利用收缩工具能够纵向地穿过腔48朝向第二套筒端部44和收缩丝线26推进(例如，如图1B-C所示)。在一些实施方式中，锁定机构70具有(i)解锁状态，在该解锁状态中锁定机构允许收缩丝线26移动通过锁定机构，并且增加设置在腔内的丝线的纵向比例，和(ii)锁定状态，在该锁定状态中锁定机构阻止丝线穿过锁定机构移动。
一旦通过将收缩丝线26拉入腔48中(并穿过锁定机构70)实现套筒25的期望收缩量，就将锁定机构70锁定(例如，使用工具60)，工具60因此也充当与腔48内的锁定机构70接合的锁定件工具64。锁定机构70的锁定阻止收缩丝线向后移出腔，因此维持了套筒的期望收缩量。例如，锁定到收缩丝线26的锁定机构70可能太大而无法经由孔离开腔48，丝线26通过该孔在第二套筒端部44处进入腔。
然后可以将工具60与丝线26去耦接(分离，decoupled)，并从植入物22移除(图1E)。对于系统20包括引导构件28的应用，例如通过工具60的促进，该引导构件也与植入物22去耦接。
要注意的是，丝线26的产生的多余部分56(即，已经穿过锁定机构70且不用于维持套筒25的收缩的丝线的部分，例如，未处于拉力下的丝线的部分)设置在腔48内。发明人假设，这样，与其中收缩丝线的多余部分设置在套筒25的外部的假设的类似植入物相反，，有利地无需移除收缩丝线的多余部分(例如，通过切割)。
现在参考图2A-E，其是根据本发明的一些应用的用于治疗天然瓣膜10的瓣环成形术系统120的示意图。系统120包括植入物122，植入物122包括：例如，如上文所述，经过必要的修改，植入物主体24(包括套筒25)和收缩丝线26。通常，除非说明，否则植入物122及其植入是如上文关于植入物22及其植入描述，经过必要的修改的那样。
如关于植入物22描述的，植入物122的丝线26可以相对于套筒25布置，使得将丝线26拉入腔中和/或增加设置在腔内的丝线的纵向比例纵向地使套筒收缩。
图2A-E显示了系统120，其不包括上文所述的引导构件，如引导构件28。然而，在一些实施方式中，系统120实际上可包括引导构件，和/或系统20可以不包括引导构件。
系统120包括锁定机构170。然而，与系统20的锁定机构70相比，系统120的锁定机构170是植入物122的部件，并且植入物122在锁定机构通常在第二套筒端部44处耦接到套筒25的情况下可经腔地推进到心脏。在一些实施方式中，锁定机构170的至少部分(例如，全部)设置在腔48的外部。
系统120包括锁定件工具164，锁定件工具164接合锁定机构170，并且被配置以将锁定机构转变成锁定状态。然而，与系统20的锁定件工具164相比，系统120的锁定件工具164在腔48外部接合锁定机构170。对于某些应用，锁定机构170被偏置以呈现其锁定状态，并且锁定件工具164被配置以将锁定机构维持在其解锁状态，同时锁定件工具与锁定机构接合。对于这样的应用，锁定件工具164与锁定机构170的脱离允许锁定机构转变成其锁定状态。本文所述的其它锁定机构和锁定件工具也可经过必要的修改以此方式进行操作。
图2A示意性地显示了在将其于瓣膜10处植入之后的植入物122，其中每个锚定件32的组织耦接构件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环中。为了清楚起见，未显示组织耦接构件34穿入的组织。在一些实施方式中，如所示，第二丝线端54在植入之前和/或植入期间设置在套筒25的腔内。
在将植入物122植入后，使用收缩工具160来促进植入物的收缩。收缩工具160包括丝线接合构件162，丝线接合构件162可纵向移动到腔48中，并穿过腔到达第二丝线端54，然后丝线接合构件162可逆地耦接到第二丝线端54(图2B)。对于使用锚定件32来锚定植入物主体24的应用，工具160被设定尺寸以能够推进穿过腔48经过已经设置在腔内的锚定件头36。
当耦接到第二丝线端54时，丝线接合构件162可朝向第一套筒端部42纵向移动(例如，通过向近侧拉动)，使得第二丝线端朝向第一套筒端部移动，从而将收缩丝线26拉入腔48中，并纵向地使套筒25收缩(图2C)。
在套筒25收缩期间，锁定机构170处于其解锁状态，例如，通过锁定件工具164维持在解锁状态。一旦通过将收缩丝线26拉入腔48中(并穿过锁定机构170)实现了套筒25的期望收缩量，就例如使用锁定件工具164，通常通过使锁定件工具与锁定机构脱离来将锁定机构170锁定(图2D)。然后可以将工具160(例如，其丝线接合构件162)与丝线26去耦接，并从植入物22移除(图2E)。丝线26的产生的多余部分56，例如，如上文关于系统20描述，经过必要的修改，有利地设置在腔48内。
现在参考图3A-D，其是根据本发明的一些应用的用于治疗天然瓣膜10的瓣环成形术系统220的示意图。系统220包括植入物222，植入物222包括：例如，如上文所述，经过必要的修改，植入物主体24(包括套筒25)和收缩丝线26。通常，除非说明，否则植入物222及其植入是如上文关于植入物22和/或植入物122描述，经过必要的修改的那样。
如关于植入物22和122描述的，植入物222的丝线26相对于套筒25布置，使得将丝线26拉入腔中和/或增加设置在腔内的丝线的纵向比例纵向地使套筒收缩。
植入物222包括调节机构280，调节机构280例如在第二套筒端部44处耦接到植入物主体24(例如，耦接到套筒25)。调节机构280耦接到收缩丝线26，并且被配置使得调节机构的致动通过将丝线进给到腔中来增加设置在腔48内的丝线的纵向比例。对于某些应用，调节机构280设置在腔48的外部。对于某些应用，调节机构280设置在腔48内或部分设置在腔内。通常，调节机构280被配置以在调节机构致动时不收集收缩丝线26。即，调节机构280的致动通常不使收缩丝线26收集在调节机构上或调节机构中。确切地说，调节机构280将收缩丝线26从调节机构的一侧移动到调节机构的另一侧。对于某些应用，通过旋转来致动调节机构280。例如，如图3A所示，调节机构280可包括绞盘282，例如，设置在壳体284内。然而线轴的旋转会使收缩丝线26收集在线轴上，绞盘282的旋转不收集收缩丝线，而是在收缩丝线从绞盘的一侧进给到另一侧时维持围绕绞盘的收缩丝线的恒定匝数。
发明人假设使用绞盘的另一特别的优点在于，由于围绕绞盘的丝线的匝数得以维持，因此绞盘的每转所引起的收缩量保持恒定。
对于某些应用，植入物222还包括引导管286，引导管286的至少部分设置在腔48内。例如，引导管286可以从调节机构280延伸到腔48中。引导管286比套筒25窄。调节机构280的致动使收缩丝线26进给到引导管286中。对于某些应用，引导管286衬有低摩擦衬里，如PTFE，以便于丝线26滑动通过该管。发明人假设管286有利地促进第二丝线端54穿过腔48朝向第一套筒端部42滑动。
图3A示意性地显示了在将其于瓣膜10处植入之后的植入物222，其中每个锚定件32的组织耦接构件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环中。为了清楚起见，未显示组织耦接构件34穿入的组织。在一些实施方式中，如所示，第二丝线端54在植入之前和/或植入期间设置在套筒25的腔内。
在将植入物222植入后，收缩工具260用于通过致动调节机构280来促进植入物的收缩。对于通过旋转来致动调节机构280的应用，收缩工具260包括旋转工具。
对于某些应用，植入物222在收缩工具260与其耦接(例如，接合调节机构280)的情况下植入。
对于某些应用，并且如所示，系统220可包括细长的引导构件228，细长的引导构件228可逆地耦接到植入物222(例如，耦接到调节机构280)，并远离植入物222向近侧延伸(例如，从对象中离开)。在将植入物222植入之后，使收缩工具260沿引导构件228(例如，在引导构件228上)推进到调节机构280(图3B)。当与调节机构280接合时，收缩工具260致动调节机构，将收缩丝线26进给到腔48中(例如，进入管286中)，通常使第二丝线端54朝向第一套筒端部42移动(图3C)。
随后，收缩工具260与调节机构280脱离，并从对象移除(图3D)。如所示，引导构件228(如果使用的话)也与植入物222去耦接(例如，与调节机构280去耦接)并从对象中移除。对于某些应用，收缩工具260用于使引导构件228与植入物去耦接。
对于某些应用，系统220包括锁定机构270。与锁定机构70相反，而类似于锁定机构170，系统220的锁定机构270是植入物222的部件，并且植入物222在锁定机构通常在第二套筒端部44处耦接到套筒25的情况下可经腔地推进到心脏。在一些实施方式中，锁定机构270耦接到调节机构280，并且也可设置在壳体284内。在其解锁状态下，锁定机构270通常通过允许调节机构270的致动来允许收缩丝线26移动到腔48中。在其锁定状态下，锁定机构270可通过阻止调节机构270的致动来阻止收缩丝线26移入腔48中。
对于某些应用，收缩工具260包括或充当锁定件工具264，并且被配置以将锁定机构270转变成锁定状态。对于某些应用，锁定机构270被偏置以呈现其锁定状态，并且锁定件工具264被配置以将锁定机构保持在其解锁状态，同时锁定件工具与锁定机构和/或调节机构280接合。
现在参考图4A-D，其是根据本发明的一些应用的用于治疗天然瓣膜10的瓣环成形术系统320的示意图。除了所指出的情况外，系统320及其部件，经过必要的修改，通常与系统20及相应命名的部件相同。系统320包括植入物322，植入物322包括：例如，如上文所述，经过必要的修改，植入物主体24(包括套筒25)和收缩丝线326。收缩丝线326类似于收缩丝线26，除了其它远离套筒25向近侧延伸。
图4A示意性地显示了在将其于瓣膜10处植入之后的植入物322，其中每个锚定件32的组织耦接构件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环中。为了清楚起见，未显示组织耦接构件34穿入的组织。对于一些实施方式，如所示，收缩丝线326穿过腔48朝向并经过第一套筒端部42，并远离套筒25向近侧延伸，使得第二丝线端54通常设置在对象的外部。
在将植入物322植入之后，收缩工具360用于促进植入物的收缩。收缩工具360在收缩丝线326上朝向植入物322向远侧滑动(图4B)。收缩丝线326向近侧被拉动，从而使套筒25收缩(图4C)。收缩工具360可提供抵抗套筒25的近端的相反的力。
系统320还包括锁定机构370(例如，锁定件等)，锁定机构370耦接到收缩工具360，并且利用收缩工具能够沿收缩丝线326纵向地推进到植入物322。锁定机构370具有(i)解锁状态，在该解锁状态中锁定机构允许收缩丝线326穿过锁定机构移动，和(ii)锁定状态，在该锁定状态中锁定机构阻止丝线穿过锁定机构移动。一旦实现了套筒25的期望收缩量，就将锁定机构370锁定(例如，使用工具360)，工具360因此也充当锁定件工具364。锁定机构370的锁定阻止收缩丝线返回，因此维持了套筒25的期望收缩量。例如，锁定到收缩丝线26的锁定机构370可能太大而无法进入腔48。工具360然后可以切割丝线326的多余部分356，并从植入物22移除(图1E)。
要注意的是，与系统20、120和220不同，在系统320中，由使套筒25收缩而产生的收缩丝线326的多余部分356设置在套筒的腔48的外部，因此可将其切割以避免丝线的此松散部分在心脏内自由移动。
要注意的是，与系统20、120和220的收缩丝线26不同，系统320的收缩丝线326的近侧部分充当引导构件，调节工具可沿着该引导构件朝向植入物推进。
再次参考图1A-4D。对于本发明的某些应用，给定系统的锁定机构可用单向机构，如棘轮，经过必要的修改来代替。单向机构将耦接到收缩丝线，并在第二套筒端部处耦接到套筒，并且将被配置以允许丝线穿过单向机构单向移动。系统将被布置使得单向机构(i)允许增加设置在腔内的丝线的纵向比例，和(ii)阻止减小设置在腔内的丝线的纵向比例。
现在参考图5A至图5C，其是根据本发明的一些应用的用于治疗天然瓣膜10的瓣环成形术系统420的示意图。除了所指出的情况外，系统420，包括其部件及植入，经过必要的修改，通常与系统20、相应命名的部件、以及其植入相同。系统420包括植入物422，植入物422包括：例如，如上文所述，经过必要的修改，植入物主体24(包括套筒25)和收缩丝线26。
图5A示意性地显示了在将其于瓣膜10处植入之后的植入物422。植入物422显示附接有每个锚定件32的组织耦接元件34，组织耦接元件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环，但是其它附接装置(例如，缝合线、夹子等)也是可能的。为了清楚起见，未显示组织耦接构件34穿入的组织。第一丝线端52通常在第一套筒端部42处附接(例如，固定地附接)到套筒25，并且丝线26关联套筒的周向壁从第一套筒端部延伸到第二套筒端部44。在一些实施方式中，如所示，通过沿第一套筒端部42和第二套筒端部44之间的周向壁编织或作为该周向壁的部分编织的丝线来提供丝线26和周向壁46之间的关联。
植入物422包括调节机构480，调节机构480例如在第二套筒端部44处耦接到植入物主体24(例如，耦接到套筒25)。丝线26相对于套筒25和调节机构480布置，使得将丝线拉入调节机构中纵向地使套筒收缩(例如，使部分42和44更近地拉在一起)。对于某些应用，如所示，调节机构480设置在腔48的外部。对于某些应用，调节机构480设置在腔48内或部分设置在该腔内。
调节机构480包括滑轮系统482和致动器486。对于某些应用，调节机构480还包括容纳滑轮系统482和/或致动器486的壳体488。对于调节机构480包括壳体488的应用，通常可从壳体外部接近致动器486(例如，其致动器接口496)。尽管调节机构480显示为设置在套筒25的外部，但是对于某些应用，调节机构设置在套筒的腔内。
滑轮系统482包括多个滑轮484，多个滑轮484包括至少第一滑轮484a和第二滑轮484b。致动器486通常耦接到滑轮系统482，使得致动器的致动调节滑轮484a和484b之间的距离。滑轮系统482与丝线26接合，使得增加第一和第二滑轮之间的距离将丝线拉入调节机构480中(例如，进入其壳体488)，从而纵向地使套筒收缩。因此，与调节机构280相比，调节机构480被配置以在致动时收集丝线26。然而，要注意的是，尽管丝线26被收集在调节机构480内，但是丝线不是通过增加丝线围绕调节机构的滑轮的缠绕来收集的。图5C显示了以虚影表示的滑轮484a的初始位置，以及以正常线表示的484a的调整位置。通过调节机构480的致动所增加的滑轮484a和484b之间的距离的量显示为距离增加量d1。
通常，滑轮系统482和丝线26机械地配合，使得以距离增加量d1来增加滑轮484a和484b之间的距离使比距离增加量d1长的一部分丝线拉入调节机构中，从而通常纵向地使套筒25以大于该距离增加量的收缩长度d2收缩(如图5C所示)。在一些实施方式中，这是通过以是距离增加量的倍数的往复布置将丝线26布置在调节机构内(例如，在滑轮系统内，如在滑轮484之间)来实现的。
对于某些应用，滑轮系统482和丝线26机械地配合，使得被拉到调节机构480中的丝线的部分是距离增加量的至少两倍长，(例如，至少是四倍长，如至少是六倍长)，例如，2-10倍长。对于某些应用，滑轮系统482和丝线26机械地配合，使得收缩长度d2是距离增加量的至少两倍长(例如，至少四倍长，如至少六倍长)，例如，2-10倍长。
对于某些应用，滑轮系统482包括至少3个滑轮484，例如，其中丝线26的至少3个(如至少4个)丝线部分以往复布置方式布置。对于某些应用，滑轮系统482包括至少4个滑轮，例如，其中丝线26的至少4个(如至少5个)丝线部分以往复布置方式布置。对于某些应用，滑轮系统482包括至少5个滑轮，例如，其中丝线26的至少5个(如至少6个)丝线部分以往复布置方式布置。图5A-C显示了包括5个滑轮484(标记为484a-e)，其中丝线26的6个丝线部分以往复布置方式布置的滑轮系统482的实施方式。丝线的丝线部分标记为26a-f。对于此实施方式，当每个丝线部分以距离增加量变长，距离增加量被乘以约6倍。即，被拉入调节机构480中的丝线的部分，和/或收缩长度d2，是距离增加量d1的约6倍长。
对于某些应用，并且如所示，滑轮系统482类似于用于使重负载提升的滑车组(滑轮组，block-and-tackle)装置，其中每个滑轮484安装在两个框架490中的一个或另一个上，使得每个框架和安装在其上的滑轮(一个或多个)共同限定各自的“区块(block)”492。然而，对于常规的滑车组，负载通常附接到其中一个区块，并且所施加的力经由“绳索”输入——通过拉动绳索以将区块一起移动，机械上的优势是通过牺牲所移动的距离使力放大来提供的。相比之下，对于调节机构480，所施加的力经由区块输入——通过将区块移动分开，被拉入调节机构中的丝线的量被放大。
对于滑轮484安装在两个框架中的一个或另一个上以限定区块的实施方式，距离增加dl(在上文中通常被定义为滑轮之间的距离的增加)与两个区块(或其两个框架)之间的距离的增加相同。在所示实施方式中，滑轮484a、484c和484e被安装到第一框架490a，从而限定了第一区块492a，并且滑轮484b和484d被安装到第二框架490b，从而限定了第二区块492b。因此，距离增加d1可以被定义为滑轮(例如，滑轮484a和484b)之间的距离的增加、框架490a和490b之间的距离的增加、和/或区块492a和492b之间的距离的增加。
滑轮484中的每个通常包括轮，例如，该轮响应于丝线26在其上移动而被动地旋转。然而，每个滑轮484可包括不同的适合的轴承，其包括，例如不旋转的光滑曲面。例如，每个轴承可以是固定的销，丝线可在固定的销上滑动。
致动器486可以是线性致动器。对于某些应用，并且根据所示实施方式，致动器486包括旋转构件，并且通过施加旋转力使旋转构件旋转来致动。例如，并且如所示，旋转构件可包括丝杠494，丝杠494的旋转使区块492中的一个相对于另一区块线性地移动。
如上所述，滑轮系统482拉入的丝线526的长度大于滑轮和/或区块移动分开的距离。因此，尽管常规的滑车组通过牺牲距离使力放大，但是调节机构480(例如，其滑轮系统482)通常通过牺牲力来使距离放大。发明人假设，因此有利的是将滑轮系统482与提供机械优势的致动器组合，以便将足够大的使植入物422及其所锚定的组织收缩的力施加到滑轮系统(例如，施加到其区块492a)。发明人假设包括丝杠494的致动器486就是这种致动器。
在将植入物422植入之后，将调节工具(例如，收缩工具)460推进(例如，经腔地)到所植入的植入物，在所植入的植入物处，调节工具460与调节机构480的调节接口496接合(图5B)。工具460用于经由接口496(例如，通过引起丝杠494的旋转)来致动调节机构480，从而使植入物422收缩(图5C)。对于植入物422包括植入在天然瓣膜瓣环处的瓣环成形术结构的应用，此收缩导致天然瓣膜瓣环的再次塑形。
对于某些应用，并且如图所示，在系统420中(即，在植入物422中)，收缩丝线26的两端保持固定在适当位置(例如，相对于套筒25)，而与植入物的调节无关。例如，第一丝线端52可以在第一套筒端部42处附接(例如，固定地附接)到套筒25，并且第二丝线端54可以附接(例如，固定地附接)到调节机构480的在致动时相对于套筒25不移动的部件——如框架490b(如图所示)或壳体488。任选地，第二丝线端可以附接(例如，固定地附接)到调节机构480的在致动时相对于套筒25不移动的部件——如框架490a。
现在参考图6A-D和7A-E，其是用于治疗天然瓣膜10的示例性瓣环成形术系统520的示意图。除了所指出的情况外，系统520及其部件，经过必要的修改，通常与系统20，包括相应命名的部件及其植入相同。系统520包括植入物522，植入物522包括：例如，如上文所述，经过必要的修改，植入物主体24(包括套筒25)和收缩丝线526。收缩丝线526类似于收缩丝线26，不同的是它远离套筒25向近侧延伸，这将在下文中更详细地描述。植入物522还包括锁定件570，锁定件570例如在第二套筒端部44处耦接到植入物主体24(例如，耦接到套筒25)。
图6A-D显示了锁定件570及其与丝线526的关联，并且图7A-E显示了根据本发明一些应用的系统520的使用时的至少一些步骤。丝线526和套筒25之间的关联是这样的：经由锁定件570将丝线的渐进区域拉离套筒，渐进地、纵向地使套筒收缩(例如，将部分42和44更近地拉在一起)。对于某些应用，并且如所示，锁定件570设置在套筒25的腔48的外部。对于某些应用，调节机构480设置在腔48内或部分设置在该腔内。
图7A示意性地显示了在将其于瓣膜10处植入之后的植入物422。图7A描绘了植入物422，其中每个锚定件32的组织耦接构件34延伸穿过套筒25的周向壁并进入瓣膜的瓣环，但是其它附接装置(例如，缝合线、夹子等)也是可能的。为了清楚起见，未显示组织耦接构件34穿入的组织。第一丝线端52通常在第一套筒端部42处附接到(例如，固定地附接到)套筒25，并且丝线526关联套筒的周向壁从第一套筒端部延伸到第二套筒端部44。在一些实施方式中，如图所示，通过沿第一套筒端部42和第二套筒端部44之间的周向壁编织或作为该周向壁的部分编织的丝线来提供丝线26和周向壁46之间的关联。
锁定件570包括被动绞盘572。锁定件570还可包括容纳绞盘的壳体574，绞盘旋转地耦接到壳体(例如，旋转地安装在壳体内)。丝线526(i)关联套筒25的周向壁从第一套筒端部42延伸到第二套筒端部44，(ii)延伸穿过锁定件570，围绕绞盘572至少缠绕一次，并且(iii)远离锁定件和套筒延伸。如图7A所示，植入物522经植入处于此状态中，使得丝线526远离植入部位向近侧延伸，通常从对象中离开。通常，丝线526围绕绞盘572缠绕至少两次。在所示示例中，丝线526围绕绞盘572缠绕三整匝。
通常，系统520包括引导构件530，引导构件530包括挠性管532。引导构件530的远侧部分534可逆地耦接到锁定件570，并且丝线526经由管，远离锁定件和套筒延伸。这尤其在图6A和6D中有所示例。对于某些应用，并且如图所示，部分534和锁定件570之间的耦接是螺纹耦接。植入物522可以经植入处于此状态中，例如，如图7A所示。
丝线526围绕绞盘572的缠绕以便丝线穿过锁定件570的移动使绞盘旋转。尽管不希望受到特定理论的约束，但是发明人假设这是由于皮带摩擦引起的。要当注意的是，术语“被动绞盘”(包括说明书和权利要求书)是指响应于丝线526的移动而被动旋转的绞盘，例如，与主动旋转以拉动丝线的绞盘相反。
锁定件570具有独立的解锁状态和锁定状态，并且能够在解锁状态和锁定状态之间可逆地切换。在解锁状态中，绞盘572是可旋转的(例如，相对于壳体574和/或相对于套筒25)，从而促进丝线穿过锁定件的移动。在锁定状态下，绞盘572的旋转至少在一个方向上被锁定，从而防止丝线穿过锁定件移动。再次，尽管不希望受到特定理论的约束，但是发明人假设对丝线的移动的这种阻止是皮带摩擦引起的。
通常，虽然锁定件570向着处于锁定状态而偏置，但是不必如此。
对于某些应用，并且如所示，绞盘572的旋转锁定由至少一个棘爪580提供。对于锁定件570向着处于锁定状态而偏置的这种应用，至少一个棘爪可被偏置以使绞盘572相对于壳体574旋转地锁定。
对于某些应用，并且如图所示，至少一个棘爪580附接到绞盘572，并且被配置以通过接合壳体而使绞盘相对于壳体574旋转地锁定。例如，壳体574可被塑形以限定凹部576，并且至少一个棘爪580可被配置以通过突出到凹部中而与壳体接合。
在将植入物522植入之后，将调节工具560经腔地推进到植入物(图7B)。在一些实施方式中，在丝线526的近侧部分上并沿着丝线526的近侧部分推进工具560。对于系统520包括引导构件530的应用，管532已设置在丝线526上，并且工具560在管532上并沿着管532(以及在管532内的丝线526上并沿着管532内的丝线526)被推进。
工具560接合锁定件570，并且用于将锁定件切换到解锁状态(图7C)。例如，工具560可以将棘爪580推出凹部576，和/或可以阻止至少一个棘爪接合凹部。对于某些应用，并且如所示，壳体574包括按钮578，当按压时，按钮578通过阻碍棘爪接合凹部而将锁定件切换到解锁状态。对于这样的应用，工具560可以按压按钮578，例如，如所示。
随后，经由锁定件将丝线526远离套筒向近侧拉动，从而纵向地使植入物522收缩(图7D)。如图所示，棘爪580响应于丝线526的移动而旋转。对于某些应用，工具560(例如，其近侧部分)被配置以拉动丝线526。对于某些应用，经由不同装置，例如用工具560拉动丝线526，工具560仅用来使锁定件570解锁并提供反作用力以便于丝线的拉动。
一旦达到期望的收缩程度，锁定件570就被切换到锁定状态(图7E)。例如，对于锁定件570向着处于锁定状态而偏置的应用，可例如通过释放按钮578就允许锁定件自动返回锁定状态。在此阶段，工具560可从对象移除(例如，如图7E所示)。任选地，可通过重复先前的步骤，经过必要的修改，对植入物522的收缩进行进一步调节。
在一些实施方式中，在将植入物522收缩之后，将多余的丝线526去除。例如，工具560可包括切割器，或者可以使用专用的切割器——例如，在丝线526(和/或引导构件530，如果仍然存在引导构件530的话)上并沿着丝线526推进。
通常，在将植入物522收缩之后，使引导构件530与锁定件570去耦接(例如，旋开)，并从对象中移除。这是通过图7E中缺少引导构件来示例的。对于某些应用，引导构件530与工具560同时被移除。对于某些应用，在移除工具560后，引导构件530留在适当位置至少一段时间，例如，以便于对用于移除多余丝线526的切割器重新调节和/或便于对用于移除多余丝线526的切割器推进。
对于某些应用，在锁定状态下，绞盘的旋转被双向锁定。任选地，并且如所示，在锁定状态下，绞盘的旋转被单向锁定，例如，使得丝线526能够向近侧穿过锁定件570以使植入物522收缩，但是不能再次向后移动。在解锁状态下，绞盘572可双向旋转。
对于某些应用，并且如所示，锁定件570被配置以能够锁定在绞盘572的多个旋转位置中的任一个中。因此，对于某些应用，至少一个棘爪580被偏置以使绞盘572相对于壳体574旋转地锁定在多个旋转位置中。例如，并且如所示，锁定件570可包括多个棘爪580，每个棘爪580被偏置以将绞盘572相对于壳体旋转地锁定在相应的旋转位置中。在所示示例中，锁定件570包括围绕绞盘572分布的三个棘爪580，以120度的间隔提供三个旋转锁定位置。
对于某些应用，锁定件570还包括机械电阻器590，机械电阻器590被配置以部分地抵抗丝线穿过锁定件的移动，而与锁定件是处于解锁状态还是锁定状态无关。发明人假设电阻器590例如通过维持缠绕绞盘的丝线的张力来提供对丝线526更大的控制。电阻器590可以以多种形式中的一种来提供，但是在所示示例中，电阻器是由弹簧592将其压靠丝线526的棒。
要注意的是，尽管丝线526缠绕绞盘572，但是在套筒25收缩期间这种缠绕不增加。在套筒25收缩期间，丝线526不被收集在锁定件570内。
发明人假设，例如，与某些其它锁定机构相比，锁定件570提供了至少两个益处。首先，锁定件570(例如，其绞盘572)和丝线526之间的接触量通常始终保持恒定，而与锁定件570是处于锁定状态还是解锁状态无关，并且与套筒25的收缩程度无关。因此，“锁定”实际上是锁定件的两个部件之间的锁定——例如，与所引起的将锁定件的部件锁定到丝线相反。其次，锁定件570提供与丝线526的大量接触，因此，与可在较小表面积上接触丝线的锁定件(如可卷曲的珠子(crimpable bead))相比，锁定件对丝线施加的锁定力散布在丝线的较大表面积上。假设这些特征有利地提高了控制性、可靠性和安全性。
涉及本文的系统和装置的方法可包括上述任一个步骤，例如，用来对系统、装置、部件等进行植入、附接、收缩、锁定等的步骤。在一些实施方式中，方法涉及经血管(例如，经股等)将系统、装置、植入物等推进到目标位置，如心脏瓣膜瓣环或心脏瓣膜瓣环的仿真物(simulation)。方法涉及将系统、装置、植入物等附接到目标位置(例如，在前述的推进之后)。附接可涉及锚定、缝合、夹紧、和/或使用其它附接装置将系统、装置、植入物等附接至目标位置。方法还涉及使系统、装置、植入物等收缩，这可通过对收缩丝线拉动或以其它方式对收缩丝线施加力(收缩丝线可以如以上任一个实施方式中所描述的那样附接、配置和/或布置)来完成，从而使系统、装置、植入物等收缩(例如，收缩成具有较小长度、直径和/或曲率半径的构型)。可以如以上关于任一个实施方式所描述的那样完成收缩。方法还可包括将锁定机构、锁定件、锁定装置等锁定，从而将系统、装置、植入物等保持在收缩构型中。锁定机构、锁定件、锁定装置等可与上述锁定机构、锁定件、锁定装置中的任一个相同，并且以与其相同的方式起作用和/或操作。
本领域技术人员将认识到，本发明不限于以上已经具体显示和描述的内容。确切地说，本发明的范围包括上文描述的各种特征的组合和子组合，以及本领域技术人员在阅读以上描述时会想到的未存在于现有技术中的其变型和修改。例如，所描述的用于与本文描述的植入物中的一种一起使用的工具，经过必要修改，可任选地与本文描述的植入物中的另一种一起使用。类似地，所描述的用于本文描述的植入物中的一种的调节机构或锁定件，经过必要修改，可任选地用于本文描述的植入物中的另一种。此外，本文描述的方法、技术、步骤等中的每种都可以在活体动物或非活体尸体、尸体心脏、模拟器、拟人幻影等上执行。
Claims (21)
1.用于对象的心脏处的设备，所述设备包括瓣环成形术带，所述瓣环成形术带包括：
柔性套筒，具有第一套筒端部、第二套筒端部、和在所述第一套筒端部和所述第二套筒端部之间限定纵向腔的周向壁；和
具有第一丝线端和第二丝线端的细长收缩丝线，所述第一丝线端在所述第一套筒端部处附接到所述套筒，并且所述丝线与所述周向壁关联，从所述第一套筒端部延伸到所述第二套筒端部，
其中所述第二丝线端设置在所述腔内，
其中所述丝线相对于所述套筒布置，使得通过将所述丝线拉入所述腔中，所述第二丝线端朝向所述第一套筒端部的移动增加设置在所述腔内的所述丝线的纵向比例，并且纵向地使所述套筒收缩。
2.根据权利要求1所述的设备，还包括多个锚定件，所述多个锚定件中的每个锚定件可独立地推进到所述腔中，并且被配置以通过经驱动穿过所述周向壁并进入组织中而将所述套筒锚定到所述组织。
3.根据权利要求1-2中任一项所述的设备，其中通过沿着所述第一套筒端部和所述第二套筒端部之间的周向壁编织，所述丝线与所述周向壁关联，从所述第一套筒端部延伸到所述第二套筒端部。
4.根据权利要求1-2中任一项所述的设备，还包括单向机构，所述单向机构耦接到所述丝线，被配置以允许所述丝线通过所述单向机构单向移动，并且以这样的布置在所述第二套筒端部处耦接到所述套筒：(i)允许增加设置在所述腔内的所述丝线的纵向比例，和(ii)阻止减小设置在所述腔内的所述丝线的纵向比例。
5.根据权利要求1所述的设备，还包括：
多个锚定件，所述多个锚定件中的每个锚定件：
包括锚定件头和组织接合构件，
可独立地推进到所述腔中，并且
被配置以通过将所述组织接合构件驱动穿过所述周向壁并进入组织中，同时所述锚定件头保留在所述腔中而使所述套筒锚定到所述组织；和
收缩工具，包括丝线接合构件，其中所述丝线接合构件，在使用所述锚定件将所述套筒锚定之后：
可纵向地移动到所述腔中并穿过所述腔到所述第二丝线端，
能够在所述腔内可逆地耦接到所述第二丝线端，并且
当耦接到所述第二丝线端时，可朝向所述第一套筒端部纵向移动穿过所述腔并经过所述锚定件头，使得所述第二丝线端朝向所述第一套筒端部移动，从而将所述丝线拉入所述腔中并纵向地使所述套筒收缩。
6.根据权利要求1-2中任一项所述的设备，还包括收缩工具，所述收缩工具包括丝线接合构件，其中所述丝线接合构件：
可纵向地移动到所述腔中并穿过所述腔到所述第二丝线端，
能够可逆地耦接到所述第二丝线端，并且
当耦接到所述第二丝线端时，可朝向所述第一套筒端部纵向移动，使得所述第二丝线端朝向所述第一套筒端部移动，从而将所述丝线拉入所述腔中并纵向地使所述套筒收缩。
7.根据权利要求1-2中任一项所述的设备，还包括锁定机构，所述锁定机构具有：
解锁状态，在所述解锁状态中，所述锁定机构允许所述丝线移动穿过所述锁定机构，并增加设置在所述腔内的所述丝线的纵向比例，和
锁定状态，在所述锁定状态中，所述锁定机构阻止所述丝线穿过所述锁定机构移动。
8.根据权利要求7所述的设备，其中所述锁定机构是所述瓣环成形术带的部件并且耦接到所述套筒，并且所述瓣环成形术带在所述锁定机构耦接到所述套筒的情况下可经腔地推进到所述心脏。
9.根据权利要求7所述的设备，其中所述锁定机构设置在所述腔的外部。
10.根据权利要求7所述的设备，其中所述锁定机构设置在所述腔的内部。
11.根据权利要求7所述的设备，其中所述锁定机构在所述第二套筒端部处耦接到所述套筒。
12.根据权利要求8-11中任一项所述的设备，还包括收缩工具，所述收缩工具包括丝线接合构件，其中
所述丝线接合构件：
可纵向地移动到所述腔中并穿过所述腔到所述第二丝线端，
在所述腔内可逆地可耦接到所述第二丝线端，并且
当耦接到所述第二丝线端时，可朝向所述第一套筒端部纵向移动，使得所述第二丝线端朝向所述第一套筒端部移动，从而将所述丝线拉入所述腔中并纵向地使所述套筒收缩，并且
所述锁定机构：
耦接到所述收缩工具，并且
使用所述收缩工具，可朝向所述第二套筒端部和所述丝线纵向地推进穿过所述腔。
13.根据权利要求8-11中任一项所述的设备，还包括锁定件工具，所述锁定件工具接合所述锁定机构，并且被配置以将所述锁定机构转变成所述锁定状态。
14.根据权利要求13所述的设备，其中所述锁定件工具在所述腔外接合所述锁定机构。
15.根据权利要求13所述的设备，其中所述锁定件工具在所述腔内接合所述锁定机构。
16.根据权利要求14-15中任一项所述的设备，其中所述锁定机构被偏置以呈现所述锁定状态，所述锁定件工具被配置以使所述锁定机构保持在所述解锁状态，同时所述锁定件工具与所述锁定机构接合，并且所述锁定件工具被配置以通过与所述锁定机构脱离而将所述锁定机构转变成所述锁定状态。
17.根据权利要求1-2、5、8-11和14-15中任一项所述的设备，其中：
所述瓣环成形术带还包括调节机构，所述调节机构在所述第二套筒端部处耦接到所述套筒，并且耦接到所述丝线，并且
所述调节机构可被配置使得所述调节机构的致动通过将所述丝线进给到所述腔中来增加设置在所述腔内的所述丝线的纵向比例。
18.根据权利要求17所述的设备，其中所述调节机构包括绞盘。
19.根据权利要求17所述的设备，其中所述调节机构被配置以在所述调节机构致动时不收集所述丝线。
20.根据权利要求18-19中任一项所述的设备，还包括引导管，所述引导管从所述调节机构延伸到所述腔中，所述调节机构的致动通过将所述丝线进给到所述管中而将所述丝线进给到所述腔中。
21.根据权利要求18-19中任一项所述的设备，还包括设置在所述腔内的引导管，其中所述调节机构的致动将所述丝线进给到所述管中。
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- 2019-01-23 WO PCT/IL2019/050092 patent/WO2019145947A1/en unknown
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2020
- 2020-06-01 US US16/889,621 patent/US11779463B2/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| CN116531147A (zh) | 2023-08-04 |
| CN111655200A (zh) | 2020-09-11 |
| US20200289267A1 (en) | 2020-09-17 |
| US11779463B2 (en) | 2023-10-10 |
| US20240000571A1 (en) | 2024-01-04 |
| EP3743015A1 (en) | 2020-12-02 |
| WO2019145947A1 (en) | 2019-08-01 |
| CA3086884A1 (en) | 2019-08-01 |
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