CN105555231B - 心外膜锚固装置和方法 - Google Patents

心外膜锚固装置和方法 Download PDF

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CN105555231B
CN105555231B CN201480050061.7A CN201480050061A CN105555231B CN 105555231 B CN105555231 B CN 105555231B CN 201480050061 A CN201480050061 A CN 201480050061A CN 105555231 B CN105555231 B CN 105555231B
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R·维德伦德
M·克里斯蒂安松
C·埃克瓦尔
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Abstract

本文描述了用于锚固人工心脏瓣膜的装置和方法。在一些实施例中，装置包括系绳附接构件，其包括限定系绳通路(235)的至少一部分的基部构件(240)，经由系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过。基部构件限定了与系绳通路相交的锁定销通道(234)。锁定销(226)能够布置在锁定销通道中并且能够在第一位置和第二位置之间运动，在第一位置，锁定销与系绳通路间隔开一定距离，在第二位置，锁定销与系绳通路相交并且能够接合布置在其中的系绳的一部分，以便将系绳固定到系绳附接构件。

Description

心外膜锚固装置和方法
相关申请的相交引用
本申请要求在2013年8月1日提交的申请号为61/861,356且发明名称为“荷包心外膜垫装置(Pursestring Epicardial Pad Device)”的美国临时专利申请以及在2013年10月25日提交的申请号为61/895,975且发明名称为“改进的心外膜垫装置(ImprovedEpicardial Pad Device)”的美国临时专利申请的优先权和权益，通过全文引用将其公开内容并入本文。本申请也是在2014年3月25日提交的申请号为14/224,764且发明名称为“荷包心外膜垫装置(Pursestring Epicardial Pad Device)”的美国专利申请的部分继续申请，该美国专利申请要求在2013年8月1日提交的申请号为61/861,356且发明名称为“荷包心外膜垫装置(Pursestring Epicardial Pad Device)”的美国临时专利申请的优先权和权益，通过全文引用将其公开内容并入本文。
技术领域
本文描述的实施例涉及用于锚固诸如人造心脏瓣膜置换件这样的医疗装置的装置和方法。
背景技术
用于锚固医疗装置例如人造心脏瓣膜(例如，二尖瓣)的一些已知装置能够包括将从医疗装置延伸的一根或多根系绳固定到身体组织。例如，一根或多根系绳能够从人造心脏瓣膜延伸通过心脏的心室壁中的开口。锚固或者固定系绳的一些已知方法能够包括使用U形钉或者其它紧固件以接合或刺入在穿刺部位附近的组织。这样的装置可能具有相对较大的轮廓并且难以经由皮肤便捷地输送至期望的锚固部位。固定人造心脏瓣膜的一些已知方法能够包括缝合从瓣膜延伸至身体组织的系绳或者栓系缝合线的端部。这样的装置和方法可能难以操纵成用期望的张力固定一根或多根系绳。
此外，当直接在心脏的心室壁或者心尖上形成开口时，诸如当经皮输送和布置人造瓣膜时，除了将人造瓣膜固定在适当位置之外，密封穿刺部位的效力对于患者的生命而言至关重要，原因在于因心脏穿刺而造成的血流动力学损失能够在几分钟内导致休克和死亡。此外，当穿刺部位位于心肌自身中时由穿刺部位承受的向外压力远高于穿刺部位位于心脏远侧的情况。因此，用于固定人造心脏瓣膜以及用于接合和闭合组织例如闭合心脏穿刺部位的改进装置和方法被认定为能够有效地解决现有技术中已知的各种问题。
发明内容
本文描述了用于锚固人造心脏瓣膜的装置和方法。在一些实施例中，一种装置包括系绳附接构件，所述系绳附接构件包括基部构件，所述基部构件限定系绳通路的至少一部分，经由所述系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过。基部构件限定了锁定销通道，所述锁定销通道与系绳通路相交。锁定销能够布置在锁定销通道中并且能够在第一位置和第二位置之间运动，在所述第一位置，锁定销与系绳通路间隔开一定距离，在所述第二位置，锁定销与系绳通路相交并且能够接合布置在其中的系绳的一部分，以便将系绳固定到系绳附接构件。
附图说明
图1是具有植入其中的人造二尖瓣的心脏的一部分以及将二尖瓣锚固就位的心外膜锚固装置的截面图。
图2是根据一实施例的心外膜锚固装置的示意图。
图3是根据一实施例的心外膜锚固装置的侧视图。
图4是图3的心外膜锚固装置的分解侧视图一
图5是图3的心外膜锚固装置的侧视图，其被示出为布置成在心室壁的心外膜表面中与穿刺部位间隔开一定距离，并且示出了处于未压缩状态或构造中的心外膜锚固装置的套垫；
图6是图5的心外膜锚固装置和心室壁的侧视图，示出了锚固装置被压靠在穿刺部位和心室壁上并且套垫处于压缩的状态或构造中；
图7是根据另一实施例的心外膜锚固装置的分解侧视图；
图8是根据另一实施例的心外膜锚固装置的分解侧视图；
图9是根据一实施例的柔性垫的俯视图，所述柔性垫能够被包括在心外膜锚固装置中；
图10是图9的柔性垫以及布置成从中穿过的系绳的一部分的透视图；
图11是根据一实施例的锁定销和系绳附接构件的透视图；
图12是图11的系绳附接构件的仰视透视图；
图13是根据一实施例能够在锚固装置内使用的系绳附接构件的俯视透视图，其中，杠杆臂被示出为处于第一位置；
图14是图13的系绳附接构件的截面透视图，其中，杠杆臂被示出为处于第一位置；
图15是图13的系绳附接构件的截面侧视图，其中，杠杆臂被示出为处于第一位置并且系绳的一部分延伸穿过该装置；
图16是图13的系绳附接构件的截面侧视图，其中，杠杆臂被示出为处于第二位置并且系绳的一部分延伸穿过该装置；
图17是根据一实施例的系绳附接构件的截面透视图，其中，锚固装置的操作臂被示出为处于第一位置并且系绳的一部分延伸穿过该装置；
图18是图17示出的系绳附接构件的侧截面图，其中，操作臂处于第一位置并且系绳的一部分延伸穿过该装置；
图19是图17的系绳附接构件的透视图，其中，输送装置联接到所述系绳附接构件；
图20是图19的系绳附接构件和输送装置的一部分的放大视图；
图21是图17的系绳附接构件的俯视透视图，其中，操作臂被示出为处于第二位置；
图22是根据另一实施例的心外膜锚固装置的俯视透视图；
图23是图22的心外膜锚固装置的俯视图；
图24是图22的心外膜锚固装置的分解视图；
图25是图22的心外膜锚固装置的截面透视图，其中，该装置的锁定销被示出为处于第一位置；
图26是图20的心外膜锚固装置的截面侧视图，其中，该装置的锁定销被示出为处于第一位置；
图27是图22的心外膜锚固装置的截面俯视图，其中，锁定销被示出为处于第二位置；
图28和29分别是图22的心外膜锚固装置的衬套的俯视透视图和仰视透视图；
图30是图22的心包垫装置的一部分的放大的俯视图；
图31是图22的心外膜锚固装置的透视图，其中，输送装置联接到所述心外膜锚固装置。
具体实施方式
本文描述的装置和方法例如能够用于固定和锚固人造心脏瓣膜譬如人造二尖瓣。本文描述的装置和方法还能够用于闭合在执行植入人造心脏瓣膜的手术时所形成的穿过心脏的开口。本文描述的装置和方法还能够用于锚固其它的医疗装置和/或闭合在诊断或者治疗程序期间在其它的身体管腔中形成的穿孔或者开口。
在一些实施例中，一种装置包括系绳附接构件，所述系绳固结构件包括基部构件，所述基部构件限定了系绳通路的至少一部分，经由所述系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过。基部构件限定了与系绳通路相交的锁定销通道。锁定销能够布置在锁定销通道中并且能够在第一位置和第二位置之间运动，在所述第一位置，锁定销与系绳通路间隔开一定距离，在所述第二位置，锁定销与系绳通路相交并且能够接合布置在系绳通路中的系绳的一部分，以便将系绳固定到系绳附接构件。
在一些实施例中，一种装置包括系绳附接构件，所述系绳附接构件包括基部构件和杠杆臂，所述杠杆臂能够运动地联接到基部构件。基部构件和杠杆臂一起限定了系绳通路，经由所述系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过。基部构件限定了锁定销通道，所述锁定销通道与系绳通路相交并且与之流体连通，并且锁定销布置在锁定销通道中。杠杆臂构造成用以从第一位置和第二位置运动，在所述第一位置，系绳的一部分能够插入到系绳通路中，在所述第二位置，锁定销将布置在系绳通路内的系绳固定到系绳附接构件。
在一些实施例中，一种装置包括系绳附接构件，所述系绳附接构件包括基部构件和衬套，所述衬套能够旋转地联接到基部构件。基部构件和衬套均限定了系绳通路的至少一部分，经由所述系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过。基部构件限定了锁定销通道，所述锁定销通道与系绳通路相交并且与之流体连通，并且锁定销至少部分地布置在锁定销通道内。衬套限定了凸轮通道，锁定销的起子部分被接收在所述凸轮通道中。衬套构造成用以相对于基部构件旋转，从而凸轮通道使锁定销在锁定销通道内直线运动，以使锁定销从第一位置和第二位置运动，在所述第一位置，锁定销与系绳通路间隔开一定距离，在所述第二位置，锁定销与系绳通路相交并且接合布置在系绳通路中的系绳的一部分，以便将系绳固定到系绳附接构件。
在一些实施例中，一种方法包括将从人造心脏瓣膜延伸的系绳的一部分插入到由系绳附接构件限定的系绳通路中。系绳附接构件布置成毗邻心脏的心室壁中的开口，系绳从所述开口延伸。致动系绳附接构件，以使得布置在由系绳附接构件限定的锁定销通道中的锁定销与系绳通路相交并且接合布置在系绳通路内的系绳的一部分，以便将系绳固定到系绳附接构件。
当在本说明书中使用时，除非上下文另有说明，否则单数形式的“一”、“一个”和“所述”包括复数个指代对象。因此，例如，术语“一个构件”旨在表示单个构件或者多个构件的组合，“一种材料”旨在表示一种或多种材料或者其组合。
当在此使用时，词语“近侧”和“远侧”指的分别是靠近和远离例如医疗装置的操作者的方向。因此，例如，医疗装置最靠近患者身体(例如，接触患者身体或者布置在患者身体内)的端部是指医疗装置的远端，而与远端相对并且最靠近例如医疗装置的使用者(或者使用者的手)的端部是指医疗装置的近端。
在一些实施例中，本文描述的心外膜垫系统能够用于锚固可压缩的人造心脏瓣膜置换件(例如，人造二尖瓣)，能够使用经导管输送系统将其布置到封闭的跳动心脏中。能够经由例如微创手术譬如利用肋间空间或者剑突下空间进行瓣膜引导的手术来布置这样的可调整系绳和心外膜垫系统。在这样的手术中，人造瓣膜能够形成为使其能够被压缩以装配在输送系统中，并且能够从输送系统被二次排入到目标部位例如二尖瓣或者三尖瓣的瓣环中。
可压缩的人造二尖瓣能够具有这样的形状，例如，所述形状的特征在于是包含瓣叶和心房套箍的管状支架本体。这允许瓣膜座置在二尖瓣瓣环内并且由原生二尖瓣瓣叶保持。利用心尖部系绳附接的柔性瓣膜的使用能够提供顺应心脏的运动和几何结构的顺应性。心脏的几何结构和运动众所周知地通过心肌增厚和相继的扭转运动而呈现出复杂的双阶段左心室变形。额外使用心尖部固定的心室系绳有助于保持人造瓣膜的瓣环位置并且不允许瓣膜移动，同时充分减小了套箍和心肌小梁之间的张力，并且优选地消除瓣周泄漏。使用顺应性人工心脏瓣膜以及特定的形状和特征结构能够有助于减小或消除凝血和血流动力学问题，其中包括左心室流出道(LVOT)干涉问题。多种已知的瓣膜都不能够解决血液流动和主动脉/大动脉瓣膜压缩的问题。
在结构上，人造心脏瓣膜能够包括：自膨胀式管状框架，所述自膨胀式管状框架在一个端部(心房端部)处具有套箍；优选地位于瓣膜的心室末端处或者心室末端附近的一个或多个附接点，一根或多根系绳能够附接到所述一个或多个附接点；和瓣叶组件，所述瓣叶组件包含瓣叶，所述瓣叶能够由稳定的组织或者其它适当的生物材料或合成材料形成。在一个实施例中，瓣叶组件可以包括线材成型件，其中，成形的线材结构结合稳定的组织一起使用，以建立瓣叶支撑结构，所述瓣叶支撑结构能够具有1个、2个、3个或4个瓣叶或者布置在其中的瓣膜尖瓣。在另一个实施例中，瓣叶组件能够是无线材的并且仅仅使用稳定的组织和支架本体来提供瓣叶支撑结构，并且所述瓣叶支撑结构能够具有1个、2个、3个或4个瓣叶或者布置在其中的瓣膜尖瓣。
上套箍部分可以通过加热成形管状镍钛诺结构(例如由编织线材或者激光切割管形成)的一部分而形成，使得下部分保持管状，而上部分从管状部分张开并且膨胀以形成增宽的套管结构，所述套管结构能够成形为各种功能性的规则或不规则的烟囱状或者套管状的形状。
如本文所述，人造二尖瓣能够经由联接到锚固装置的一根或多根系绳在心脏外部的位置处锚固到心脏。例如，系绳能够联接到人造二尖瓣且延伸离开心脏，并且利用锚固装置固定在外部位置(例如心外膜表面)，如本文所述。在其它的手术情况中，如本文所述的锚固装置能够与一根或多根这样的系绳一起使用，在所述其它的手术情况中，可以要求这样的系绳从管内腔延伸到外部的锚固部位。
图1是心脏的左心室LV和左心房LA的截面图，心脏具有布置在其中的经导管的人造二尖瓣PMV和如本文所述的心外膜锚固装置EAD，所述心外膜装置EAD将人造二尖瓣PMV固定就位。图1图解了人造二尖瓣PMV，所述人造二尖瓣PMV座置在原生瓣膜环中并且利用人造二尖瓣PMV的心房套箍AC、来自原生瓣叶的径向张力以及心室系绳T保持在此，所述心室系绳T利用附接部分Tp固定到人造二尖瓣PMV和心外膜锚固件EAD。参照具体实施例在下文更加详细地描述心外膜锚固装置的不同实施例。
图2是根据一实施例的心外膜锚固装置100的示意图(在本文中也称作“锚固装置”或者“心外膜锚固件”)。锚固装置100能够用于锚固或者固定布置在心脏的左心房和左心室之间的人造二尖瓣PMV。锚固装置100例如能够用于经由如参照图1在上文描述的缝合系绳128锚固或固定人造二尖瓣PMV。锚固装置100还能够在植入人造二尖瓣PMV期间密封形成在心脏的心室壁(图2中未示出)的穿孔。锚固装置100还能够应用在其它用途中，以便锚固医疗装置(诸如任何人造房室瓣或者其它心脏瓣膜)和/或密封诸如穿孔这样的开口。
锚固装置100能够包括垫(或者垫组件)120、系绳附接构件124和锁定销126。在一些实施例中，锚固装置100能够包括参照图3至图6所述的套垫(图2中未示出)。垫120能够接触心脏的心外膜表面并且能够由任何适当的生物可相容的手术材料构成。垫120能够用于辅助密封当植入人造二尖瓣时形成的手术穿孔。在一些实施例中，垫120能够包括狭槽，所述狭槽径向延伸到垫120的边缘，以使垫120能够通过使垫120经由狭槽滑动到系绳128上而附接到或者布置在系绳128周围。参照图9和图10在下文描述了这样的实施例。
在一些实施例中，垫120能够由双面绒材料制成，以便促进垫120向内生长到穿刺部位区域中。例如，垫或者毡纱布能够由毡状聚酯制成并且可以被切割成任何适当的尺寸或者形状，诸如Bard的产品PTFE Felt Pledgets，其标称厚度为2.87mm。在一些实施例中，垫120的直径能够大于系绳附接构件124的直径。垫120能够具有圆形或者盘形或者其它适当的形状。
系绳附接构件124能够提供锚固和安装平台，一根或多根系绳128能够联接到所述锚固和安装平台(例如，拴系或者用销联接)。系绳附接构件124能够包括：基部构件(未示出)，所述基部构件至少限定了系绳通路的一部分(未示出)，系绳128能够通过所述系绳通路被接收并且穿过系绳附接构件124；和锁定销通道(未示出)，能够通过所述锁定销通道接收锁定销126。正如参照具体实施例在下文更加详细描述的那样，锁定销通道能够与系绳通路流体连通，以使得当锁定销126布置在锁定销通道中时，在锁定销穿过系绳通路时锁定销126能够接触或者刺穿系绳128。
锁定销126能够用于在锚固装置100已经被紧固抵靠在心室壁上并且系绳128已经被拉成期望的张紧状态之后将系绳128保持就位。例如，系绳128能够延伸穿过垫120中的孔、穿过套垫(如果锚固装置包括套垫的话)中的孔以及穿过系绳附接构件124的系绳通路。当系绳128延伸穿过系绳附接构件124的系绳通路时，锁定销126能够插入锁定销通道内或者在锁定销通道内运动，以使其刺穿或者以其他方式接合系绳128。因此，锁定销126能够与系绳128相交并且将系绳128固定到系绳附接构件124。
系绳附接构件124能够由各种适当的生物可相容材料形成。例如，在一些实施例中，系绳附接构件124能够由聚丙烯或者其它硬质或半硬质的聚合物制成，而且能够由聚酯丝绒覆盖，以促进向内生长。在其它实施例中，系绳附接构件124能够例如由金属(诸如镍钛诺)或者陶瓷材料制成。系绳附接构件124能够具有不同的尺寸和/或形状。例如，系绳附接构件124能够为大体盘状。
在一些实施例中，系绳附接构件124能够包括杠杆臂(图2中未示出)，所述杠杆臂能够在打开位置和闭合位置之间运动，在所述打开位置将系绳128装载在系绳附接构件124内，在所述闭合位置将系绳128固定到系绳附接构件124。例如，在一些实施例中，当杠杆臂运动到闭合位置时，系绳通路与锁定销通道成相交关系，使得锁定销126接合布置在系绳通路内的系绳128。在一些实施例中，当杠杆臂处于打开位置时，能够使用工具使锁定销在锁定销通道内运动，以使得锁定销接合布置在系绳通路内的系绳128。在这个实施例中，在锁定销126固定系绳128之后，杠杆臂能够运动到闭合位置。
在一些实施例中，系绳附接构件124能够包括衬套，所述衬套可动地联接到系绳附接构件124的基部构件。衬套能够限定通道，所述通道能够接收锁定销(或者锁定销组件)126的一部分，使得当衬套旋转时，衬套用作凸轮以使得锁定销126在锁定销通道内直线运动。正如先前的实施例，当锁定销126在锁定销通道内运动时，锁定销能够接合或者刺穿布置在系绳通路内的系绳128并且将系绳128固定到系绳附接构件124。本文参照图22至图31描述了这样的实施例。
在使用中，在PMV已经放置在心脏中之后，从PMV延伸的系绳能够插入到锚固装置100的系绳通路中并且能够将在系绳附接装置上的张力调节至期望的张力。可选地，在一些情况中，在PMV被放置在心脏内之前，即可将从PMV延伸的系绳联接到锚固装置100。能够致动锚固装置100(根据具体实施例例如是系绳附接构件124的锚固装置的某些部分或杠杆臂或衬套)，使得锁定销126与系绳通路相交并且接合系绳的布置在系绳通路内的部分，从而将系绳固定到系绳附接构件。在一些实施例中，在将系绳插入到系绳通路中之前，能够致动锚固装置100，以便将锚固装置100构造成用以接收系绳。例如，如果系绳附接构件包括可动地联接到基部构件的杠杆臂，则可能需要杠杆臂运动到打开位置以允许插入系绳。在一些实施例中，能够通过相对于系绳附接构件124的基部构件旋转衬套来致动锚固装置100，使得锁定销126从第一位置和第二位置运动，在所述第一位置，锁定销与系绳通路间隔开，在所述第二位置，锁定销与系绳通路相交并且接合或者刺穿系绳的一部分。
在图3至图6中示出了心外膜锚固装置100的一个实施例。心外膜锚固装置100(在此还称作“锚固装置”或者“心外膜锚固件”)能够包括柔性垫220、套垫222、系绳附接构件224和锁定销226(图4中示出)。锚固装置200能够用于经由图5和图6中示出的缝合系绳228锚固或者固定人造二尖瓣(图3至图6中未示出)。锚固装置200还能够密封在植入人造二尖瓣期间形成在心脏的心室壁V(参见图5和图6)中的穿孔230。
柔性垫220(在此还称作“垫”)能够接触心脏的心外膜表面并且能够由任何适当的生物可相容手术材料构成。垫220能够用于辅助密封在植入人造二尖瓣时形成的手术穿孔(例如，穿孔230)。垫220能够由所述的与垫120相同或者类似的材料制成，并且能够具有不同的尺寸和形状。垫220示出为具有圆形或者盘状的形状，然而应当理解的是能够可选地使用其它适当的形状。垫220限定了孔225(参见图4)，能够通过所述孔225接收系绳228(图5和图6所示)，正如在下文更加详细描述的那样。
套垫222能够布置在垫220和系绳附接构件224之间并且能够用于密封可能在垫220和系绳附接构件224之间出现的间隙或者泄漏。套垫222能够例如由柔性材料制成，以使得其能够在系绳附接构件224和/或垫220抵靠穿刺部位例如抵靠心室壁紧固时被压缩。套垫222可以是联接到垫220和系绳附接构件224的单独部件或者能够与垫220和/或系绳附接构件224一体地或者成整体地形成。套垫222能够用于防止可能沿着缝合系绳228的路径流动的血流动力学泄漏。套垫222还能够限定孔(未示出)，能够通过所述孔接收系绳228。
系绳附接构件224能够提供锚固和安装平台，一根或多根系绳228(参见图5和图6)能够联接(例如拴系)到所述锚固和安装平台。系绳附接构件224包括：基部构件240，所述基部构件限定了轴向系绳通路235，系绳228能够通过所述轴向系绳通路235被接收并且穿过系绳附接构件224；和锁定销通道234，能够通过所述锁定销通道234接收锁定销126。正如下文更加详细描述的那样，锁定销通道234能够与系绳通路235流体连通，以使得当锁定销226布置在锁定销通道234中时，随着锁定销226穿过系绳通路，锁定销226能够接触系绳228。锁定销226能够用于在锚固装置200已经抵靠心室壁V紧固之后将系绳228保持就位。例如，系绳228能够延伸穿过垫220中的孔225、穿过套垫222中的孔(未示出)并且穿过系绳附接构件224的系绳通路235。在系绳228延伸穿过系绳附接构件224的系绳通路235时，锁定销226能够插入穿过锁定销通道234，以使其刺穿系绳228。因此，锁定销226能够与系绳228侧向相交并且将系绳228固定到系绳附接构件224。
系绳附接构件224能够由任何适当的生物可相容材料制成。例如，在一些实施例中，系绳附接构件224能够由聚丙烯或者其它硬质或半硬质的聚合物制成，而且能够由聚酯丝绒覆盖，以促进向内生长。在其它实施例中，系绳附接构件224能够例如由金属(诸如镍钛诺)或者陶瓷材料制成。系绳附接构件224能够具有不同的尺寸和/或形状。例如，系绳附接构件224能够为大体盘状。
在一些实施例中，系绳附接构件224能够为大体盘状并且直径介于例如1.0cm至3.0cm之间。在其它实施例中，系绳附接构件224能够具有例如介于0.2cm至5.0cm之间的直径。例如，较大尺寸的系绳附接构件224可以理想地应用于例如疝修补、胃肠修补等。
用于捕获和锚固缝合线的盘状系绳附接构件224也可以使用，其对锚固部位处的组织造成的损伤很小或者没有损伤，这与使用螺丝或者倒钩钻入组织中的缝合线锚固件不同。此外，替代使用缝线，盘状系绳附接构件224可以轻易地并且快速地在系绳228上滑动，这能够实现大穿孔的有效永久闭合。通过缝合而手术地闭合大穿孔可能耗时并且困难。当闭合心脏中的穿孔时，要求外科医生缝合穿孔所增加的难度可能会增加危及患者生命的并发症的几率。这在使用经导管技术未开胸地输送和布置人造心脏瓣膜的情况中尤为如此。在这种情况中缝合心室穿孔可能是不理想的。
图5和图6图解了延伸穿过心脏的左心室壁V内的穿刺部位和联接到锚固装置200的系绳228。图5图解了在抵靠心室壁V的心外膜表面而被紧固之前的锚固装置200，以及处于未压缩状态或构造中的套垫222。系绳228能够可选地卷绕在系绳附接构件224上，以便进一步改善锚固。
图6图解了抵靠心室壁V的外心膜表面被紧固的锚固装置200。如图6所示，锚固装置200能够被压缩抵靠穿刺部位并且接触心外膜表面。能够在系绳228已经固定到系绳附接构件224之后或者在锚固装置200已经固定抵靠在心外膜表面上之后剪掉系绳228的端部部分232(图5中示出)。
图7图解了心外膜锚固装置300(在此也称作“锚固装置”或者“心外膜锚固件”)的实施例，所述心外膜锚固装置300与锚固装置200类似，区别在于锚固装置300不包括套垫(例如上述套垫222)。锚固装置300能够包括柔性垫320、系绳附接构件324和锁定销326，所述柔性垫320、系绳附接构件324和锁定销326能够分别构造成与上述的柔性垫220、系绳附接构件224和锁定销226相同或相似。锚固装置300能够与锚固装置200相同或相似地用于经由缝合系绳(未示出)固定人造二尖瓣(未示出)。例如当不需要用防漏套管来防止沿着缝合系绳的路径流动的血流动力学泄漏时，可能需要使用锚固装置300。
图8图解了心外膜锚固装置400(在此也称作“锚固装置”或者“心外膜锚固件”)的实施例，所述心外膜锚固装置400与锚固装置200和锚固装置300类似，区别在于锚固装置400不包括垫(例如，垫220和320)。锚固装置400能够包括系绳附接构件424、套垫422和锁定销426，所述系绳附接构件424、套垫422和锁定销426能够构造成分别与上述的系绳附接构件224、套垫222和锁定销226相同或者相似。锚固装置400能够以与针对上述实施例所述的相同或者类似的方式经由系绳(未示出)锚固或者固定人造二尖瓣(未示出)。例如当不需要柔性垫时，譬如当栓绳运动到新位置时，可能需要使用锚固装置400。在这样的情况下，心室穿孔较小(例如，小直径)并且可以不需要用垫来控制血流。
图9和图10图解了垫520的实施例，所述垫520能够被包括在如本文所述的心外膜锚固装置中。垫520限定了轴向孔525以及与孔525连通的狭槽537。狭槽537径向延伸至垫520的外边缘，使得垫520能够布置在系绳528周围或者能够从系绳528移除垫520(参见图10)并且不需要使垫520沿着系绳528的长度向下滑动。例如，能够通过使垫520从侧部侧向滑动而将垫520布置在系绳528周围，以使得系绳插入到狭槽537中并且定位在垫520的开口525中。垫520能够利用例如销、夹具等固定到系绳。
为了移除垫520，垫520能够类似地滑动离开侧部例如滑动到心脏的心室的顶端之外。由此，能够移除垫520，并且不需要移除整个锚固装置。垫520能够由与针对先前实施例(例如垫220、320、420)在上文描述的材料相同或者类似的材料形成，并且能够如上所述地用于闭合(例如，在心室壁中的)穿刺部位。
垫520还能够实现在心尖处使用导引器护套，所述导引器护套能够限制运动量并且穿过心尖。例如，当拉回护套时，有狭槽的垫520能够从一侧滑入，从而允许在移除护套期间控制系绳张力。也能够独立于如上所述的护套而使用具有狭槽537的垫520。
图11和图12图解了能够被包括在如本文所述的锚固装置内的系绳附接构件624的实施例。在此针对系绳附接构件624描述的各个特征也能够被包括在本文针对其它实施例(例如，124、224、324、424)所述的系绳附接构件中。如上所述，锁定销626(图11示出)能够用于以如上所述的先前实施例相类似的方式将系绳/缝合线固定到系绳附接构件624。
系绳附接构件624示出位具有盘状并且能够包括基部构件640，所述基部构件640限定了卷绕通道632、轴向系绳通路635、径向通道633和锁定销通道634，能够通过所述锁定销通道634接收锁定销626。基部构件640还限定了近侧开口615和远侧开口617，所述近侧开口615和所述远侧开口617均与系绳通路635连通。基部构件640能够包括位于近侧开口615处的倒角边缘或者引入部分627、以及位于远侧开口617处的倒角边缘或者引入部分629，以允许将缝合线(例如，系绳)方便地引入到系绳通路635中并且减小系绳附接构件624抵抗缝合线的侧向切割力。径向通道633能够允许使用者快速地捕获和安置准备进行锚固的系绳(未示出)。卷绕通道632能够允许使用者快速地将系绳卷绕在系绳附接构件624上。使用卷绕通道632和径向通道633能够允许使用者快速地锚固系绳，同时允许使用者解开并重新较准锚固装置，以便针对特定用途根据需要调节作用在系绳(未示出)上的张力。
图13至图16图解了心外膜锚固装置700的另一个实施例的一部分。心外膜锚固装置700包括系绳附接构件724和柔性垫或者织物构件(图13至图16中未示出)。系绳附接构件724包括：基部构件740，所述基部构件740限定了锁定销通道734，所述锁定销通道734能够以与针对先前实施例在上文描述的方式相类似的方式将锁定销726接收在其中；和周向的垫通道742。垫通道742能够用于将心外膜锚固装置700的柔性垫或者织物构件(图13至图16中未示出)固定到系绳附接构件724。例如，柔性垫能够布置在系绳附接构件724的远端部分上，以使得当锚固装置700如针对先前实施例在上文所述的那样固定到心室壁时，柔性垫接触心室壁。
系绳附接构件724还限定了：系绳通路735，能够通过系绳通路735接收系绳728(参见，例如图15和图16)；以及均与系绳通路735连通的近侧开口715和远侧开口717。在远侧开口717处或者在远侧开口717附近包括倒角边缘或引入部分729，以允许系绳728(参见例如图15和16)方便地穿入到系绳通路735中并且减小系绳附接构件724抵靠系绳728的侧向切割力。
杠杆臂738联接到基部构件740，所述杠杆臂738与基部构件740一起限定了系绳通路735。杠杆臂738能够在第一位置和第二位置之间运动，如图16所示地在第一位置，杠杆臂738被弹簧构件739偏压到下位置，如图13至图15所示地在第二位置，杠杆臂738处于延伸位置，以允许将系绳728放置在系绳通路735内。例如，杠杆臂738能够沿着图15中所示的箭头A方向旋转，以使杠杆臂738运动到其第二位置或延伸位置。在一些情况中，缝合线或绳索能够用于将杠杆臂738拉动至延伸的第二位置。
当如图所示处于第一位置时，例如，在图14和图15中，锁定销726的末端布置成与杠杆臂738和系绳通路735间隔开一定的距离。当锁定销726与系绳通路735间隔开时，系绳728能够如图15所示插入到系绳通路735中。然后，能够拉紧系绳728至期望张力，随后能够释放杠杆臂以使其被偏压回到第一位置，如图16所示。当杠杆臂738运动(例如，被偏压)到第一位置时，其中系绳728延伸穿过系绳通路735，锁定销726刺穿系绳728或者与系绳728相交，并且锁定销的末端随后被布置在由杠杆臂738限定的腔736内，从而将系绳728固定到系绳附接构件724。
图17至图21图解了心外膜锚固装置800的另一个实施例的一部分，所述心外膜锚固装置800包括系绳附接构件824和柔性垫或者织物构件(图17至21中未示出)。系绳附接构件824包括基部构件840和杠杆臂838，所述杠杆臂838枢转地联接到基部构件840。基部构件840限定了周向垫通道842，在所述周向垫通道842中，柔性垫能够联接到系绳附接构件824。例如，柔性垫能够布置在系绳附接构件824的远端部分上，使得当锚固装置800如针对先前实施例在上文所述的那样固定到心室壁时，柔性垫接触心室壁。
杠杆臂838和基部构件840一起限定了系绳通路835，能够通过所述系绳通路835接收系绳828，如图17所示。基部构件840还限定了均与系绳通路835流体连通的远侧开口817和另一开口。系绳828能够插入通过远侧开口817(最靠近心室壁的待植入一侧)并且延伸通过系绳通路835的由基部构件840限定的部分和系绳通路835的由杠杆臂838限定的部分，然后从所述另一开口离开。与先前实施例一样，基部构件840在系绳通路835的远侧开口817处包括倒角边缘或者引入部分829，以允许将系绳828方便地引入到系绳通路835中并且减小系绳附接构件824抵靠系绳828的侧向切割力。
杠杆臂838限定了锁定销通道844，锁定销826能够可动地布置在所述锁定销通道844中。锁定销826包括起子部分846和穿刺部分849。如图17和图18所示，锁定销通道844包括具有可变直径的部分，锁定销826的起子部分846能够可动地布置在所述部分中。例如，起子部分846能螺纹联接到锁定销通道844的内壁，使得锁定销826能够在第一位置和第二位置之间运动，如图17所示地在第一位置起子部分846布置在锁定销通道844的所述部分839内并且穿刺部分849与系绳通路835间隔开，在所述第二位置起子部分846布置在锁定销通道844的所述部分845(图17和图18所示)内，并且穿刺部分849延伸通过系绳通路835，从而接合或者刺穿系绳828。如下文详细所述，杠杆臂838还限定了开口847，所述开口847与锁定销通道844连通并且能够接收驱动工具，所述驱动工具能够用于使锁定销826在锁定销通道844内运动。
杠杆臂838能够在例如图17和图18所示的第一位置或打开位置以及如图21所示的第二位置或闭合位置之间运动，在所述第一位置或打开位置，杠杆臂838从基部构件840沿着近侧方向延伸，在所述第二位置或闭合位置，杠杆臂838的近侧表面819与基部构件840的近侧表面821基本齐平。当杠杆臂838处于第一位置或打开位置时，输送工具848能够联接到杠杆臂838，如图19和图20所示。输送工具848能够包括图18中示出的起子849(例如，螺丝刀)，所述起子849能够接合锁定销826的起子部分846，以使锁定销826在锁定销通道844内运动。
在操作中，系绳828能够插入到系绳通路835中并且从所述另一开口延伸出来且位于输送工具848内。随后能够拉紧系绳828至期望张力。在系绳828处于期望张力下的情况中，输送工具848的起子849随后能够使锁定销826从如图17所示的第一位置运动到第二位置，在所述第二位置，穿刺部分849刺穿或者接合系绳828，从而将系绳828固定到系绳附接构件824。例如，输送工具848的起子849能够使锁定销826从第一位置扭转地运动到第二位置。在系绳828固定到系绳附接构件824之后，能够移除输送工具849并且杠杆臂838能够运动到第二闭合或闭合位置，如图21所示。
图22至图30图解了根据另一个实施例的心外膜锚固装置。心外膜锚固装置900包括系绳附接构件924、垫组件920、管构件955和管盖构件956。系绳附接构件924包括基部构件940、衬套950、保持环952、锁定销组件926和销构件953。锁定销组件926包括起子部分946和穿刺部分949。基部构件940限定了周向垫通道942、保持通道951和锁定销通道934。垫通道942能够用于将垫组件920联接到系绳附接构件924。保持通道951能够接收保持环952的外边缘，所述保持环952用于将衬套950保持到基部构件940。基部构件940还限定了切口或者棘爪943，例如，如图23、25和30所示。
管构件955联接到基部构件940并且基部构件940、衬套950和管构件955一起限定了系绳通路935，能够通过所述系绳通路935接收系绳(未示出)。盖构件956能够由例如织物材料诸如Dacron形成。系绳通道935与锁定销通道934相交并且与其流体连通。
垫组件920包括顶部垫部分958、底部垫部分959和布置在其间的填料构件957。顶部垫部分958和底部垫部分959能够均由例如柔性织物材料形成。顶部垫部分958和底部垫部分959能够均限定中央开口，管构件955能够穿过所述中央开口。顶部垫部分958的一部分被接收在基部构件940的通道942内，如图25至27所示。
衬套950的外周部分被接收在保持通道951内，使得衬套950能够相对于基部构件940旋转，以便如在下文更加详细描述的那样致动锁定销组件926。如图所示，例如，在图28和图29中，衬套950包括具有凸部962的臂961。凸部962能够被接收在基部构件940的切口943中并且用作止动件或限制件，以限制衬套950的旋转。由衬套950限定的狭槽963使臂961能够弯曲并允许凸部962在切口943中运动或者运动离开切口943。如图所示，例如在图27和图29中，衬套950在衬套950的底部部分上限定了弯曲通道960。弯曲通道960为非对称(或者螺旋式)并且接收锁定销组件926的起子部分946。当衬套950相对于底部构件940旋转时，衬套950用作凸轮以使锁定销组件926在锁定销通道934内直线运动。锁定销组件926能够从第一位置运动到第二位置，在所述第一位置，穿刺部分949如图25和图26所示布置在系绳通路935之外，在所述第二位置，穿刺部分949如图27所示延伸穿过系绳通路935。销构件953(参见例如图26)能够由金属材料形成，所述金属材料较之锚固装置的其它部件不透射线性更强并且因此对于使用传统成像形式的使用者(例如医生)来说可视，以使得使用者能够确定锁定销组件926已经完全运动到第二位置。
在使用中，当锁定销组件926处于第一位置时，例如联接到人造二尖瓣并且延伸通过心脏的心室壁中的穿刺部位的系绳(未示出)能够插入通过系绳通路935。衬套950随后能够旋转180度，以使锁定销926在锁定销通道934内直线运动，使得穿刺部分949延伸通过系绳通路935并且接合或者刺穿系绳，从而将系绳固定到系绳附接构件924。例如，当锁定销处于第一位置时，衬套950的凸部962均布置在基部构件940的切口943之一内(即，第一凸部处于第一切口中，第二凸部处于第二切口中)。衬套950然后能够旋转180度，使得凸部962运动离开基部构件940的切口943，并且在180度旋转结束时，凸部962运动到基部构件940的另一个切口943内(即，第一凸部现在处于第二切口中，第二凸部现在处于第一切口中)。
基部构件940还能够包括切口段966并且限定侧开口967(参见例如图22和图23)，所述侧开口967能够用于将输送装置联接到心外膜锚固装置900。例如，图31图解了输送装置948，所述输送装置948具有联接臂968和联接销(未示出)，所述联接销从臂968向内延伸。侧开口967能够接收联接销并且切口段966能够由联接臂968接合。
尽管已经在上文描述了各种不同的实施例，但应当理解的是它们仅仅是示例而非限制性的。在上述方法指出特定事件以特定顺序发生的情况下，可以更改特定事件的顺序。另外，在可行时能够在并行处理中同时执行特定事件，以及如上所述相继地执行特定事件。
在上述示意图和/或实施例表示按照特定方向或位置来布置的特定实施例的情况中，可以修改部件的布置方案。尽管已经特别地示出并且描述了实施例，但应当理解的是可以对形式和细节作出各种变化。本文描述的装置和/或方法的任何部分均能够以任意的组合方式进行组合，相互排斥的组合除外。本文描述的实施例能够包括所述的不同实施例的功能、部件和/或特征结构的各种组合和/或子组合。

Claims (10)

1.一种用于锚固人造心脏瓣膜的装置，包括：
系绳附接构件，所述系绳附接构件包括基部构件和衬套，所述衬套能够旋转地联接到所述基部构件，所述基部构件和衬套均限定了系绳通路的至少一部分，经由所述系绳通路能够接收从人造心脏瓣膜延伸的系绳的一部分从中通过，所述基部构件限定了锁定销通道，所述锁定销通道与所述系绳通路相交并且与之流体连通；和
锁定销，所述锁定销至少部分地布置在所述锁定销通道内，衬套限定了凸轮通道，所述锁定销的起子部分被接收在所述凸轮通道中，
衬套构造成用以相对于所述基部构件旋转，从而所述凸轮通道使所述锁定销在所述锁定销通道内直线运动，以使所述锁定销从第一位置和第二位置运动，在所述第一位置，所述锁定销与所述系绳通路间隔开，在所述第二位置，所述锁定销与所述系绳通路相交并且接合布置在系绳通路中的系绳的一部分，以便将系绳固定到所述系绳附接构件。
2.根据权利要求1所述的装置，还包括：
垫，所述垫联接到所述系绳附接构件，所述垫构造成用以接触心室壁，以使得所述垫布置在心室壁和所述系绳附接构件之间。
3.根据权利要求1所述的装置，还包括：
管构件，所述管构件联接到所述基部构件，所述管构件限定了所述系绳通路的一部分。
4.根据权利要求1所述的装置，还包括：
管构件，所述管构件联接到所述基部构件，所述管构件限定了所述系绳通路的一部分；和
盖构件，所述盖构件布置在所述管构件上。
5.根据权利要求1所述的装置，其中，所述基部构件限定了棘爪，所述棘爪构造成用以在其中接收所述衬套上的凸部，以便限制所述衬套相对于所述基部构件的旋转。
6.根据权利要求1所述的装置，其中，所述凸轮通道为非对称的。
7.根据权利要求2所述的装置，其中，所述垫包括顶部垫部分、底部垫部分以及布置在所述顶部垫部分和所述底部垫部分之间的填料构件。
8.根据权利要求7所述的装置，其中，所述顶部垫部分和所述底部垫部分能够均由柔性织物材料形成。
9.根据权利要求1所述的装置，其中，所述基部构件限定一对切口段以及一对侧开口，所述一对侧开口在所述一对切口段附近限定于所述基部构件的侧壁中，
所述一对侧开口和所述一对切口段能够由输送装置的具有联接销的一对联接臂接合，所述联接销能够被接收在所述一对侧开口内。
10.根据权利要求1所述的装置，其中，当所述锁定销处于所述锁定销与所述系绳通路相交的第二位置时，所述锁定销刺穿布置在所述系绳通路内的所述系绳的一部分并且将所述系绳固定到所述系绳附接构件。
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US20200179112A1 (en) 2020-06-11
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