CN113842188A - 用于瓣膜夹子切除的方法和装置 - Google Patents

用于瓣膜夹子切除的方法和装置 Download PDF

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CN113842188A
CN113842188A CN202111032959.XA CN202111032959A CN113842188A CN 113842188 A CN113842188 A CN 113842188A CN 202111032959 A CN202111032959 A CN 202111032959A CN 113842188 A CN113842188 A CN 113842188A
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亚历克斯·海尔克哈汉
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Abstract

一种用于接近心脏瓣膜中的相对的瓣叶来切除植入的夹子的系统，该系统包括：捕获导管，该捕获导管构造成在夹子的一侧靠近瓣叶被引入；传输导管，该传输导管构造成在夹子的另一侧靠近瓣叶被引入；以及切割工具，该切割工具构造成被部署在捕获导管与传输导管之间并且构造成靠着瓣叶中的至少一者的组织接合并且构造成切除夹子。可选地，可以使用移除导管将夹子从心脏移除。

Description

用于瓣膜夹子切除的方法和装置
本发明是申请日为2017年7月6日、申请号为201780047992.5、发明名称为“用于瓣膜夹子切除的方法和装置”的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求于2017年7月5日提交的美国专利申请No.15/642,245(代理人案卷号50494-703.201)的优先权，该美国专利申请要求于2016年7月6日提交的临时申请No.62/359,121(代理人案卷号50494-703.101)，和于2016年11月7日提交的临时申请No.62/418,571(代理人案卷号50494-703.102)的权益，这些申请的全部公开内容通过参引并入本文中。
技术领域
本发明总体上涉及医疗装置和方法。更具体地，本发明涉及用于从心脏瓣膜移除夹子和其他植入假体的装置、系统、套件和方法。
背景技术
二尖瓣反流(Mitral regurgitation)是一种常见的瓣膜疾病，并且患病率随着年龄而增长。在这种情况下，血液在心脏收缩期间血液从左心室异常反流到左心房中，并且这种情况会导致许多不良后果，比如由于左心室功能障碍、心房颤动、肺动脉高压引起的心里衰竭以及死亡。公开的指南建议手术或经导管矫正二尖瓣反流，以改善临床状况。
通过植入二尖瓣夹子(特别是来自Abbott Vascular(雅培血管公司)的
Figure BDA0003245856190000011
系统)对二尖瓣反流进行的经导管矫正已经成为用于处于开放式外科矫正手术的高风险患者的标准疗法。这种夹子植入手术通过插入右股静脉中的引导导管来进行。一个或更多个二尖瓣夹子可以通过导引导管被输送并植入以重新接近前二尖瓣瓣叶和后二尖瓣瓣叶(通常被称为“边对边”修复)。
Figure BDA0003245856190000012
二尖瓣夹子是由钴铬合金制成且覆盖有织物网的金属植入物。
迄今为止，在全球范围内已经进行了超过45,000个使用
Figure BDA0003245856190000021
瓣膜夹子的手术，并且目前每个月进行近1000个手术。已发现
Figure BDA0003245856190000022
手术是非常安全的手术并且针对手术风险高的患者提供了治疗选择。
然而，常规的二尖瓣夹合技术存在一些显著的局限性。首先，一旦植入二尖瓣夹子，移除通常需要开放式手术切除。其次，由于技术挑战，并非所有患者在手术时都达到令人满意的MR减少。最后，在
Figure BDA0003245856190000023
手术的6个月内，多达1/5的患者可能有显著的MR返回或者需要重复介入。
如果患者在二尖瓣夹合手术后具有复发性MR，则用于额外治疗的当前选择是有限的。一种选择将是安置另一二尖瓣夹子，但是这通常由于担心产生二尖瓣狭窄而是不可能的(二尖瓣夹子通常使瓣膜变窄，使得瓣膜不再正常打开)。
其他选择包括变得可用的各种二尖瓣修复和置换技术。引人注意的是经导管二尖瓣置换术，在经导管二尖瓣置换术中，安装在可扩张框架上的生物假体二尖瓣被配置在有缺陷的天然二尖瓣中。这种经导管“置换”瓣膜使得二尖瓣反流完全消除并且将模拟二尖瓣置换在选定患者中的手术“黄金标准”。
目前，在已经执行了在前的二尖瓣夹合手术的情况下，可能难以或不可能植入经导管二尖瓣，因为二尖瓣夹子发生干涉并且将不允许新瓣膜完全扩张。因此，将期望提供用于从心脏瓣膜经导管移除夹子和其他植入假体的装置、系统、套件和方法。特别期望的是用于经导管从心脏瓣膜移除夹子和其他植入假体的这些装置、系统、套件和方法将使心脏瓣膜处于接受随后的经导管手术比如人工瓣膜植入的状态，以治疗瓣膜病变。这些目的中的至少一些目的将通过本文中所述描述的本发明来实现。
参见美国专利公开2014/0228871、US2015257883和US2014135799，美国专利Nos.US8500768、US7955340和US5895404，以及以下指南和出版物：Nishimura RA、Otto CM、Bonow RO等人的2014AHA/ACC guideline for the management of patients withvalvular heart disease(2014年AHA/ACC心脏瓣膜病的患者管理指南)：executivesummary(执行概要)：a report of the American College of Cardiology/AmericanHeart Association Task Force on Practice Guidelines(美国心脏病学会/美国心脏协会实践指南工作组的报告)，J Am Coll Cardiol(美国心脏病学学院杂志)2014；63：2438-88；Feldman T、Kar S、Elmariah S等人的Randomized Comparison of PercutaneousRepair and Surgery for Mitral Regurgitation(经皮修复术与二尖瓣反流手术的随机比较)：5-Year Results of EVEREST II(EVEREST II的5年结果)，J Am Coll Cardiol(美国心脏病学学院杂志)2015；66：2844-54；以及Maisano F、Alfieri O、Banai S等人的Thefuture of transcatheter mitral valve interventions(经导管二尖瓣介入的未来)：Competitive or complementary role of repair vs.replacement？(修复与置换的竞争或补充作用？)，Eur Heart J(欧洲心脏杂志)2015；36：1651-9。
发明内容
本发明提供了可以用于将一个或更多个二尖瓣夹子与天然二尖瓣瓣叶组织分离并且可选地将所述一个或更多个二尖瓣夹子从天然二尖瓣瓣叶组织移除的经导管工具和经导管手术。在这样的手术中，医生可以将专门设计的导管从左心房或左心室插入。导丝可以邻近在先植入的二尖瓣夹子被安置在瓣叶和瓣膜组织周围。利用机械切割或磨损或射频能量，可以将二尖瓣夹子从前瓣叶或后瓣叶或前瓣叶和后瓣叶两者切除，从而恢复天然瓣膜孔口并允许进行将来的修复或置换疗法。在将二尖瓣夹子与天然瓣叶组织分离之后，将预期二尖瓣反流的程度急剧恶化。相比之下，本发明的分离手术可以在进行经导管瓣膜植入或另一经导管矫正手术之前即刻进行。例如，如果使用经心尖接入来部署新的经导管二尖瓣，则可以使用经中隔接入来释放二尖瓣夹子，或者如果使用经中隔接入来部署新的经导管二尖瓣，则可以使用经心尖接入来释放二尖瓣夹子。
在本发明的第一方面，一种用于接近心脏瓣膜中的相对的一对瓣叶来切除夹子的方法包括将捕获导管在夹子的一侧邻近瓣叶引入心脏腔室中。还将传输导管在夹子另一侧邻近瓣叶引入心脏腔室中，并且将切割元件部署在传输导管与捕获导管之间，以将切割元件靠着瓣叶中的至少一者的组织安置或接合。接着使用切割构件将夹子从瓣叶中的至少一者切除，以释放固定并允许瓣叶分开。
本发明的切除方法可以用于下述任何心脏瓣膜：为了增强对合或者出于其他原因，在所述心脏瓣膜处可以将安置有夹子。最典型地，心脏瓣膜为二尖瓣，并且导管可以经中隔被引入瓣膜上方的左心房中，或者可以经心尖地被引入二尖瓣下方的左心室中。在其他情况下，目标心脏瓣膜可以为三尖瓣，并且导管可以被引入三尖瓣上方的右心房或三尖瓣下方的右心室中。
在示例性实施方式中，部署切割构件包括使捕获导管和传输导管中的至少一者并且通常两者的梢端转向，以带动这两个导管的梢端靠近瓣膜夹子。通常，捕获导管和传输导管中的至少一者可以前进穿过瓣叶之间的开口而邻近固定的瓣膜夹子，其中，前进的导管接着可以围绕瓣膜夹子的相反侧转向并且在瓣膜夹子的相反侧被向上带动穿过瓣叶之间的空间。接着可以使切割构件在传输导管与捕获导管之间传递，以跨越瓣叶的要被切除的目标区域。接着可以操纵导管以使切割构件延伸经过瓣膜夹子的一侧，使得切割构件定位成在瓣膜的一侧切除瓣叶的一部分。如下面将更详细描述的，可以将瓣膜夹子留下植入相对的瓣叶中，并且用附接至相对的瓣叶的留置的夹子来进行后续的瓣膜介入手术。替代性地，捕获导管和传输导管可以用于将切割构件重新定位在瓣膜夹子的另一侧，使得可以从夹子切除相对的瓣叶以完全释放夹子并允许在对心脏瓣膜进行后续介入之前将夹子从心脏移除。当释放并移除瓣膜夹子时，当然将必须通常通过如下文中所述的移除导管来约束瓣膜夹子。
在又一些其他具体示例中，切割构件可以通过使捕获导管上的磁性元件靠着切割构件上的磁性元件接合来部署。磁性元件通常位于捕获导管的梢端和切割构件的端部处，并且导管可以被操纵成将切割构件牵拉经过瓣膜夹子的任一侧或两侧以便切除瓣叶组织以释放夹子。
在替代性实施方式中，切割元件可以包括用于捕获切割构件的自由端部的环，并且因此捕获导管可以被操纵成使该环在切割构件的自由端部上行进并且牵拉切割元件经过夹子并穿过瓣膜组织。
在又一些其他实施方式中，部署切割构件可以包括将捕获导管的梢端和传输导管的梢端牵拉在一起以形成经过瓣膜夹子的路径并使元件在该路径上前进。在使切割构件进行这种前进并定位之后，可以操纵捕获导管和/或传输导管以操纵切割构件切除瓣膜组织从而释放夹子。
如上所述，在本发明的方法的一些实施方式中，夹子将被从仅一个瓣叶切除，使得夹子被留下植入相对的瓣叶中。将夹子从至少一个瓣叶释放将至少在一些情况下足以释放相对的瓣叶并且使得能够进行随后的瓣膜置换或其他介入手术。然而，在其他情况下，将优选的是在进行随后的瓣膜植入或其他介入之前将瓣膜夹子完全从心脏瓣膜移除。在这些情况下，在切除期间将通常使用移除导管或其他装置来约束或捕获夹子，并且在任何另外的介入之前将从心脏腔室切除的夹子取出。
在本发明的方法的又一些其他具体实施方式中，夹子可以以各种方式被从瓣叶组织切除。例如，切割构件可以包括电极部段或能够将射频(RF)切割电流输送至组织的其他导电区域。特别地，RF电流将在切割模式下输送，使得切割构件可以将与瓣膜夹子相邻的瓣膜组织切除。在其他情况下，切割构件可以包括可以用于机械切穿瓣膜组织的尖锐或研磨区域。例如，尖锐或研磨切割区域可以进行往复运动，以便其“锯”穿组织以切除瓣膜。也可以采用其他已知的组织切割方式。
如上所述，捕获导管、传输导管和切割构件用于切除单个瓣叶的组织，使得瓣膜夹子附接至相对的瓣叶。尽管将瓣膜夹子从单个瓣叶移除将允许瓣叶充分打开以便于进行随后的假体瓣膜植入或其他矫正手术，但是有时将期望的是将瓣膜夹子从两个相对的瓣叶移除。在这种情况下，将优选的是将夹子移除导管引入心脏腔室中以便使最终移除的瓣膜夹子稳定。夹子移除导管的远端部可以靠着夹子接合并且通常将附接至夹子，同时使用切割构件将夹子从一个瓣叶或两个瓣叶切除。
在又一些其他示例性实施方式中，捕获导管、传输导管和可选的夹子移除导管通常可以同时通过经中隔导管或护套而经中隔被引入。在又一些其他具体实施方式中，捕获导管、传输导管和可选的夹子移除导管通常可以同时通过经心尖护套或导管而经心尖被引入。
在本发明的第二方面中，一种用于接近心脏瓣膜中的相对的瓣叶来切除植入的夹子的系统包括捕获导管、传输导管和切割构件。捕获导管构造成在夹子的一侧邻近瓣叶被引入心脏腔室中。传输导管构造成在夹子的另一侧邻近瓣叶被引入心脏腔室中，并且切割构件构造成被从传输导管部署至捕获导管以将切割元件靠着瓣叶中的至少一者的组织安置以切除夹子。
在该系统的具体方面，捕获导管和传输导管中的至少一者将具有可转向的梢端，通常两者都具有可转向的梢端。捕获导管将通常具有磁性远端梢端，该磁性远端梢端构造成接合并捕获设置在切割构件的远端部处的磁性元件。以此方式，捕获导管上的磁性梢端可以用于吸引并接合切割构件的磁性端部，使得切割构件可以被部署在捕获导管与传输导管之间。因此，切割构件的切割区域可以定位成接合与瓣膜夹子相邻的瓣叶组织，使得切割区域可以用于切割组织并切除夹子。例如，切割区域可以包括可用于机械切割瓣膜组织的尖锐或研磨区域。替代性地，切割区域可以包括RF电极，该RF电极可以被以切割电流供电以切除与夹子相邻的瓣叶组织。
本发明的系统还可以包括用于将本发明的导管输送至心脏腔室的引导护套，该引导护套通常为经中隔护套或经心尖护套。通常，引导护套将大到足以同时至少容置捕获导管和传输导管。通常，该系统将还包括移除导管，并且引导护套将定尺寸成大到足以同时容置捕获导管、传输导管和移除导管中的每一者。
本发明的夹子移除导管通常将具有构造成接合并捕获夹子的远端部。某些瓣膜夹子、比如
Figure BDA0003245856190000061
瓣膜夹子具有提供“对接”特征的独特形状，本发明的夹子移除导管和可选的其他导管可以使用该“对接”特征，以与瓣膜夹子的心房或心室方面“对接”。瓣膜夹子的形状通常易于通过荧光镜检查看清楚，这便于在移除手术期间瞄准移除导管或其他导管并且可选地将移除导管或其他导管与夹子对接。这种对接具有若干个优点。第一，对接可以使瓣膜夹子相对于导管系统稳定，这是有利的，因为瓣膜在不停跳心脏手术期间运动。第二，对接便于使导管定向以改善切割构件的位置、例如使切割线材成环，使得切割线材使用上面所示的磁性技术或勒除器技术而环绕夹子。第三，通过将移除导管或其他导管与瓣膜夹子对接，导管和切割构件可以稳定地定位在瓣膜夹子附近，从而使弦装置被环形线材或其他切割构件缠绕或勒除的风险最小化。第四，对接可以从心房方面或心室方面进行。例如，心房对接可以通过对接到
Figure BDA0003245856190000062
夹子的“Y”形部分的顶部的凹槽中来实现。心室对接可以通过与
Figure BDA0003245856190000063
夹子的“Y”形部分的底部对接来实现。对接可以是被动的、例如经由过盈配合进行，或者可以在移除导管或其他导管具有用以牢固地附接
Figure BDA0003245856190000064
夹子的“抓持”特征的情况下是主动的。通过修改对接特征，对接可以在各个瓣膜夹子上单独进行或者在若干个瓣膜夹子上同时进行。
本发明的移除导管可以设计成与MitraClip或其他瓣膜夹子对接，以环绕夹子安置勒除器。在使用前述导管将夹子从前瓣叶和后瓣叶(或在三尖瓣的情况下的中隔瓣叶)释放之后，夹子可以通过移除导管穿过接入护套被从身体移除。移除导管可以具有在瓣膜夹子被从两个瓣叶释放之后固定瓣膜夹子以保持瓣膜夹子从而可以将瓣膜夹子从身体移除的各种夹子抓持特征中的任一者，比如勒除器、活检型钳或卡爪。捕获导管和/或传输导管还可以构造成与瓣膜夹子对接，例如，捕获导管和/或传输导管的远端梢端具有与瓣膜夹子的形状互补的形状。移除夹子的导管可以通过经静脉的经中隔方法或左心室经心尖方法安置。在一些情况下，移除导管可以设计成具有呈漏斗形形状的梢端，以允许瓣膜夹子以适当的取向被牵拉到导管中。
本发明的导管系统还可以用于环绕并移除起搏器的引线或除颤器的引线。例如，通过使环绕引线的环沿着引线的长度滑动，引线可以被从供其植入的心脏或血管组织切除。特别地，本发明的导管可以用于将引线从血管静脉组织、比如腋静脉、头臂静脉和/或上腔静脉释放。本发明的导管还可以用于将引线从三尖瓣或右心室心肌释放。特别地，在引线可能引起三尖瓣反流(TR)的情况下，可以将引线从三尖瓣释放。引线可选地被重新定位以减少TR。导管还可以用于释放导线以允许导线根据需要重新定位在三尖瓣孔口中，以便于将经导管瓣膜安置在三尖瓣位置中。
在所附权利要求中阐述了被认为是说明性示例的特征的新颖特征。然而，当结合附图阅读时，通过参照本公开的说明性示例的以下详细描述，这些说明性示例将被最好地理解，在附图中：
附图说明
图1和图1A示出了二尖瓣的在植入二尖瓣夹子之后的解剖结构。
图2A和图2B示出了根据本发明的原理构造的捕获导管，该捕获导管具有以其伸直构型(图2A)和偏转构型(图2B)示出的可操纵远端区域。
图3示出了根据本发明的原理构造的传输导管。
图4示出了在本发明的方法中与捕获导管和传输导管一起使用的切割构件。
图5A至图5E示出了捕获导管上的磁性梢端和切割构件上的磁性远端元件的不同实施方式。
图6示出了根据本发明的替代性系统，该替代性系统包括在其远端部具有捕获环的捕获导管。
图7A至图7F示出了根据本发明的原理的在用于移除植入二尖瓣中的一对夹子的方法中使用捕获导管和传输导管。
图8示出了根据本发明的原理将捕获导管和传输导管经心尖引入到左心房中以切除二尖瓣中的瓣膜夹子。
图9A至图9C示出了根据本发明的原理的在用于从三尖瓣移除瓣膜夹子的方法中使用捕获导管和传输导管。
图10A至图10E示出了根据本发明的原理的在用于从二尖瓣移除单个瓣膜夹子的方法中使用捕获导管和传输导管。
具体实施方式
本发明提供了用于将一个或更多个瓣膜夹子与二尖瓣和其他心脏瓣叶分离的装置和方法。瓣膜夹子可以位于沿着瓣膜对合平面的任何位置(中央、内侧、外侧或连合处)，并且在一些实施方式中，瓣膜夹子被从对合瓣叶中的一者移除并同时被留置于对合瓣叶中的另一者中。在其他实施方式中，瓣膜夹子将被从两个瓣叶移除并被完全从心脏抽出。
本发明的技术可以从左心房方面(经中隔或直接心房进入)或者从左心室方面(经心尖、直接心室穿刺或逆主动脉进入)部署。切割动作可以由“勒除器”、类似剪刀的装置、类似于“奶酪切割器”的基于线的切割器、射频电极切割元件等来提供。在一些情况下，二尖瓣夹子可以从前瓣叶和后瓣叶两者移除，并且可以使用勒除器、活检钳型装置或其他移除导管将二尖瓣夹子从身体完全移除。本发明可以用于从三尖瓣以及二尖瓣移除瓣膜夹子，并且这些导管通过经中隔导管和经心尖导管来安置，经中隔导管和经心尖导管通常大到足以容置在手术中同时使用的所有导管。
现在参照图1和图1A，瓣膜夹子C可以被植入心脏H中的二尖瓣MV以及三尖瓣TV的瓣叶中。二尖瓣MV将左心房LA与左心室LV分开，并且三尖瓣TV将右心房RA与右心室RV分开。为了完整性，应指出的是，血液从左心室LV通过主动脉瓣瓣膜AV流入主动脉A中。如图1A中更详细地所示，二尖瓣MV中的夹子C可以位于前瓣叶AL与后瓣叶PL之间的瓣膜开口的中间附近。然而，夹子C也可以植入在瓣叶之间的远离瓣膜开口中间的其他位置处。
现在参照图2A和图2B，捕获导管10包括轴12，轴12具有近端部14和远端部16。轴的近端部附接有控制把手18，并且在该把手的远端处设置有偏转旋钮20。捕获导管10通常还包括冲洗端口22并且将具有适于接纳导丝24的中央管腔，导丝24在其远端部具有可成形梢端26。如特别图2B中所示，导管的轴12的远端区域28将是可主动偏转或“可转向”的，使得该区域可以偏转达180°，如所示的。这种偏转将由偏转旋钮20和下述适合的偏转机构或任何其他常规的导管偏转技术来控制：所述偏转机构可以包括拉线并且在轴的远端部处具有开槽区域。
现在参照图3，传输导管34包括轴36，轴36具有近端部38和远端部40。该轴的近端部附接有控制把手42，并且在控制把手42的远端部设置有偏转旋钮44。传输导管34也可以包括冲洗端口46并且将通常具有与上面针对捕获导管10所描述梢端类似的可转向的远端梢端48。
现在参照图4，切割构件50包括长形本体52，长形本体52通常具有线状构型(在如下所述的电外科切割构件的情况下通常是导电的)，使得该长形本体可以通过传输导管34的前进管腔来给送。切割构件50还包括切割区域54，切割区域54通常跨越长形本体的长度的中间附近的区域并且通常具有0.5cm至数厘米的长度，并且切割区域54的两侧通常由不透射线标记物56结合。在电外科切割构件的情况下，该构件可以包括导电线材，其中，切割区域未被绝缘并且切割区域两侧的区域被电绝缘。在长形本体52的一个端部将通常设置有磁性远端元件58，并且如图3中所示，当切割构件50被装载到传输导管34上时，磁性远端元件58将从该导管的远端梢端40向外伸出，使得磁性远端元件58露出并且可用于磁性吸引捕获导管10的磁性梢端30，如下面所描述的。
如图5A至图5E中所示，捕获导管10的磁性梢端30可以采用各种形式。磁性梢端30a(图5A)呈子弹形状并且具有用于容置捕获导管的导丝的贯穿管腔。磁性梢端30b呈盘状形状并且也具有容置捕获导管中的导丝的贯通管腔。
切割构件50的磁性远端元件58也可以具有各种构型。最简单地，磁性远端元件58将具有如图5E中所示的球形形状。替代性地，磁性远端元件可以具有如图5B中所示的子弹形状58a或如图5D中所示的盘状形状58b。
如上所述，捕获导管10和切割构件50将各自具有磁性元件以允许由捕获导管50捕获切割构件。尽管这是优选设计，但是也可以采用各种其他捕获机构。例如，如图6中所示，捕获导管62可以在其远端部处承载捕获环66。然后，可以使用捕获环来捕获由传输导管64承载的切割构件72的自由端部70。也可以使用钩、倒钩、线圈靶等，以允许由捕获导管捕获切割构件。
现在参照图7A至图7F，将描述使用捕获导管10和传输导管34经由经中隔进路将一对夹子C1和C2从二尖瓣MV移除。导丝24的可转向的远端梢端28首先通过经中隔护套74被引入二尖瓣上方的左心房中。梢端28可以在心脏不停跳的情况下于荧光镜导引下在夹子C1与C2之间前进。可选地，捕获导管10可以用于辅助将导丝24在导管10于导丝上前进之前安置在夹子之间。导丝可以是被动的或主动的。
在导丝被安置之后，如图7A中所示，捕获导管10可以在导丝24上前进，使得捕获导管10定位在夹子C1和C2上方，如图7B中所示。接着，捕获导管10的远端部在夹子C1与C2之间前进，使得磁性梢端进入左心室，如图7C中所示。接着，传输导管34可以通过经中隔护套74与捕获导管10平行地被引入并转向以使切割构件50上的磁性远端元件58b前进，从而使得磁性远端元件58b与捕获导管10上的磁性梢端30接合。例如，传输导管34的可转向的远端区域48可以在前瓣叶AL与后瓣叶PL之间向下前进并且被操纵成使磁性远端元件58b靠着磁性梢端30接合。
在切割构件50与捕获导管10联接在一起之后，捕获导管10可以被往回拉以使切割区域54露出，并且导管被操纵成使切割区域54靠着第二瓣膜夹子C2接合，如图7E中所示。接着，切割区域54被操纵成锯穿后瓣叶PL在夹子C2周围的组织或者以电外科手术切割后瓣叶PL在夹子C2周围的组织。接着可以重复该过程以将第一夹子C1从后瓣叶PL切除，如图7F中所示，从而导致二尖瓣打开以允许进行假体瓣膜植入或其他介入。尽管在图7A至图7F中示出了后瓣叶的切除，但是在某些情况下，将优选的是切除前瓣叶组织从而使夹子附接至后瓣叶。
现在参照图8，也可以使用捕获导管10和传输导管34通过经心尖护套78来执行将瓣膜夹子C从二尖瓣MV切除。使用经心尖方法，导管10的远端梢端和导管34的远端梢端从左心室LV向上前进至左心房LA，并且接着大体如前所述的那样使用导管切除组织。
现在参照图9A至图9C，将描述切除植入三尖瓣TV的前瓣叶AL与中隔瓣叶SL之间的瓣膜夹子C。捕获导管10和传输导管34可以通过接入护套80被引入三尖瓣上方的右心房中，如图9B中所示。导管10和34可以用于将切割构件50的切割区域54于夹子C的一侧定位在中隔瓣叶SL中，如图9C所示。接着可以以前述任何方式操纵切割构件50，以切除中隔瓣叶SL的组织以释放夹子C并打开三尖瓣，如图9C中所示。在对瓣膜进行后续介入之前，也可以将夹子C的被植入前瓣叶中的部分切除，或者可以使夹子留在原位。
现在参照图10A至图10E，大体如前所示的，可以通过使用经中隔护套74将捕获导管10和传输导管34引入左心房中来将单个瓣膜夹子C从二尖瓣MV移除。另外，可以通过经中隔护套74将夹子移除导管90与捕获导管10和传输导管34同时通过引入，以便接合夹子C并使夹子C变稳定。如图10A中所示，可以将位于操纵线材92的远端部处的夹子捕获元件94输送穿过夹子移除导管90的管腔以捕获夹子C的上表面。接着使用切割构件50的切割区域54来切除前瓣叶AL中的组织且同时通过夹子移除导管90来保持并稳定夹子，从而将夹子从前瓣叶释放，如图10B中所示(其中，为了便于说明而移除了捕获导管10和传输导管34)。接着可以对捕获导管34和传输导管10进行重新定位，如图10C中所示，使得切割构件50的切割区域54靠着后瓣叶PL定位，并且接着可以操纵切割区域以切除后瓣叶中组织，从而释放夹子，如图10D中所示。接着可以使用继续保持夹子C的夹子移除导管90将夹子C从二尖瓣取出，如图10E所示。于是，二尖瓣MV完全不具有植入的夹子，以便接纳二尖瓣假体或者进行另一矫正介入。
尽管已经详细描述了本公开的某些实施方式，但是某些变型和改型对于本领域技术人员而言将是明显的，包括没有提供本文中所描述的所有特征和益处的实施方式。本领域技术人员将理解的是，本公开超出了具体公开的实施方式并且延伸到了本发明的其他替代性或附加的实施方式和/或用途以及其明显的改型和等同物。另外，尽管已经以不同的细节示出且描述了许多变型，但是本领域技术人员基于本公开将容易明白在本公开的范围内的其他改型。还可以预期的是，可以进行实施方式的具体特征和方面的各种组合或子组合并且仍然落在本公开的范围内。因此，应当理解的是，所公开的实施方式的各种特征和方面可以彼此组合或替代，以形成本公开的不同模式。因此，预期本文中所公开的本公开的范围不应受上述公开的特定实施方式的限制。对于上述所有实施方式，任何方法的步骤不需要按顺序执行。

Claims (15)

1.一种用于接近心脏瓣膜中的相对的瓣叶来切除植入的夹子的系统，所述系统包括：
捕获导管(10，62)，所述捕获导管(10，62)构造成邻近所述夹子的一侧被引入心脏腔室中；
传输导管(34，64)，所述传输导管(34，64)构造成邻近所述夹子的另一侧被引入所述心脏腔室中；
切割构件(50，72)，所述切割构件(50，72)构造成从所述传输导管(34，64)至所述捕获导管(10)部署，以将切割元件(54，72)靠着所述瓣叶中的至少一者的组织安置以切除所述夹子，以及
夹子移除导管(90)，所述夹子移除导管(90)构造成邻近所述夹子被引入心脏腔室中，所述夹子移除导管(90)包括夹子捕获元件，所述夹子捕获元件构造成与所述夹子接合并捕获所述夹子。
2.根据权利要求1所述的系统，其中，所述夹子捕获元件(94)被输送穿过所述夹子捕获元件(94)的管腔。
3.根据权利要求2所述的系统，其中，输送护套(74)同时容置所述捕获导管(34，64)、所述传输导管(34，64)和所述夹子移除导管(90)。
4.根据权利要求3所述的系统，其中，所述输送护套(74)包括经中隔护套。
5.根据权利要求3所述的系统，其中，所述输送护套(74)包括经心尖护套。
6.根据权利要求1所述的系统，其中，所述捕获导管(10)包括中央管腔以容置导丝。
7.根据权利要求6所述的系统，其中，所述捕获导管(10)包括远端稍端(30)，所述远端稍端(30)具有用以容置所述导丝的管腔。
8.根据权利要求7所述的系统，其中，所述远端稍端(30)具有子弹形状或者盘状形状。
9.根据权利要求1所述的系统，其中，所述捕获导管(62)在其远端部承载捕获环(66)。
10.根据权利要求9所述的系统，其中，所述切割构件(72)具有自由端部，所述捕获环(66)被用来捕获所述自由端部。
11.根据权利要求1所述的系统，其中，所述捕获导管(10)和所述运输导管(34)中的至少一者具有可转向的远端稍端。
12.根据权利要求1所述的系统，其中，所述捕获导管(10)和所述运输导管(34)中的每一者均具有可转向的远端稍端。
13.根据权利要求1所述的系统，其中，所述切割构件(50)包括射频电极以用于通电切割瓣膜组织。
14.根据权利要求1所述的系统，其中，所述切割构件(50)包括机械研磨或尖锐边缘以用于机械切割瓣膜组织。
15.根据权利要求1所述的系统，其中，所述切割构件(50)包括由不透射线标记物(56)描绘的切割区域(54)。
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