CN110151359A - 二尖瓣修复和替换设备及方法 - Google Patents
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Abstract
本发明涉及二尖瓣修复和替换设备及方法。一种用于修复和/或替换天然二尖瓣的功能的植入物和方法,在各种实施例中,该植入物和方法被配置为减少或消除二尖瓣反流和残余二尖瓣渗漏。具有在植入后尺寸减小的中心匝的卷成圈的锚定件被用于粗略估计天然二尖瓣环尺寸的减小和重塑天然二尖瓣环形状,以减少瓣膜渗漏。能够将夹具进一步应用于天然瓣膜小叶,以减小天然二尖瓣环的尺寸并且减少通过其的渗漏。能够在卷成圈的锚定件中植入人工心脏瓣膜以替换和进一步改善瓣膜的功能。在某些情况下,能够在被夹住的瓣膜中植入人工瓣膜,其中夹具从天然瓣膜小叶中的一个分离,以为人工瓣膜扩张提供空间。
Description
本发明为申请日为2015年09月11日、发明名称为“二尖瓣修复和替换设备及方法”的中国专利申请201580047893.8(PCT/US2015/049811)的分案申请。
本申请要求于2014年9月12日提交的美国临时专利申请No.62/049,432的优先权和权益,其内容通过引用整体并入本文;并且还要求于2014年10月31日提交的美国临时专利申请No.62/073,088的优先权和权益,其内容也通过引用整体并入本文。
技术领域
本发明总体涉及关于心脏二尖瓣修复的医疗设备和手术以及人工心脏瓣膜。更具体地,本发明涉及具有畸形或功能障碍的心脏瓣膜的修复和/或替换。本发明的实施例涉及用于重塑天然二尖瓣的形状或调整天然二尖瓣尺寸的设备和方法,用于减少在二尖瓣环处的残余渗漏的进一步治疗,以及例如当渗漏持续时用人工心脏瓣膜替换二尖瓣的功能。
背景技术
首先总体参考图1和图2,二尖瓣控制在人心脏的左心房和左心室之间的血液流动。在左心房经由肺静脉从肺接收氧合血液之后,二尖瓣允许氧合血液从左心房流入左心室中。当左心室收缩时,保持在左心室中的氧合血液通过主动脉瓣和主动脉递送到身体的其余部分。同时,二尖瓣在心室收缩期间闭合,以防止血液流回左心房中。
二尖瓣包括前小叶和后小叶。当左心室收缩时,前小叶和后小叶汇聚在一起,并且左心室中的血压大幅增加以促使二尖瓣闭合。由于在心室收缩期间左心室和左心房之间的大的压差,所以出现了二尖瓣的小叶脱垂或翻转回到心房中的可能性。为防止这种情况,一系列腱索沿左心室的相对的壁将二尖瓣连接到***肌。在图1的心脏横截面图和图2的二尖瓣的俯视图中示意性地示出了腱索。在心室收缩之前和期间,***肌也收缩并维持腱索中的张力,以保持二尖瓣的小叶处于闭合位置并且防止其从内到外翻转并回到心房中,从而还防止氧合血液回流到心房中。
从左心房看到的二尖瓣及其小叶的总体形状如图2所示。二尖瓣并发症可能导致致命性心力衰竭。瓣膜性心脏病的一种形式是二尖瓣渗漏,也称为二尖瓣反流,其特征在于血液通过二尖瓣从左心室异常地渗漏回左心房中。
二尖瓣反流是常见的问题,并且已经研究了减少或预防二尖瓣反流的可以更容易地被患者的身体耐忍或处理的各种选项。
一种用于患有二尖瓣反流或其他二尖瓣渗漏的患者的修复方案采用导管手术,其中前小叶的自由边缘附接到后小叶的自由边缘。该手术的想法由Ottavio Alfieri博士提出,Ottavio Alfieri博士描述了一个患有先天性异常的前小叶边缘融合到后小叶边缘的患者,并推测这可能为二尖瓣反流提供良好的解决方案。Alfieri博士执行了许多手术,其中通过使用瓣环成形术环进行减小而修复二尖瓣环,以重塑天然二尖瓣环的形状使其更小和/或更圆或以其他方式一致,并且然后通过以期望的布置使前小叶片边缘接近并附接到后小叶边缘来控制残余渗漏。利用瓣环成形术的组合来减小二尖瓣环的直径和小叶边缘接近度,可以通过已知的Alfieri手术来修复和改善许多渗漏二尖瓣的性能。
Alfieri手术已经导致基于导管的手术的其他变型,以附接前小叶和后小叶的边缘从而控制二尖瓣反流。在一种手术中,在超声心动图和荧光镜引导下,使用导管在二尖瓣环处引入夹具,该夹具将前小叶的自由边缘紧固到后小叶的自由边缘。夹具和递送***通常被引入患者的股静脉中并且进入心脏的右侧。然后,在患者心脏中进行经中隔穿刺,并且将夹具推进到左心房中,然后推进到左心室中。然后,将小叶的边缘与夹具紧固在一起,并且取出递送***。在该手术的其他变型中,夹具和递送***可以替代地从患者身体上的各种其他进入点或进入位置中的一个引入患者的心脏中。
大部分患者在此类手术期间应用一个夹具,但是如果渗漏严重并且/或者小叶高度分散,也可应用附加的夹具。临床结果令人满意。当与经历手术之前相比时,许多患者已经表现出显著减少的渗漏,并且症状上得到很大改善。
进一步减少二尖瓣渗漏的另一选项是将上述瓣环成形术手术中的一种与边缘到边缘小叶折叠手术结合或作为其的补充,以进一步加强天然二尖瓣小叶之间的结合或附接。
发明内容
然而,即使在经历一个或更多个上述手术之后,一些患者仍然具有显著的二尖瓣渗漏。这增加了对心脏的负荷,并且心脏会由于此残余的瓣膜回流的长期作用而受损。
根据本发明的实施例,提供了一种具有不同曲率半径的螺旋锚定件或卷成圈的锚定件(coiled anchor)以更有效地减少和/或重塑天然二尖瓣环的形状,从而减少二尖瓣处的渗漏。在重塑天然二尖瓣环的形状和/或调整天然二尖瓣环的尺寸之后,如果仍然观察到渗漏,则能够更容易或更有效地向重构的二尖瓣环应用附加的措施,诸如边缘到边缘修复或其他修复手术。
在采用上述瓣环成形术手术或其他类似的环减小手术中的一种之后补救连续渗漏的另一替代方案中,能够将人工二尖瓣进一步植入到二尖瓣环中,因为使用根据本发明的实施例的卷成圈的锚定件的瓣环成形术手术将导致形成稳定的锚定件或基部,其中人工二尖瓣能够对接在该锚定件或基部中或抵靠该锚定件或基部。
根据本发明的实施例,用于重塑心脏的天然二尖瓣的形状的植入物包括具有第一端部、第二端部,和在第一端部与第二端部之间延伸的中心轴线的卷成圈的锚定件。卷成圈的锚定件限定与中心轴线同轴的内部空间,并且包括限定内部空间的具有第一宽度的中心部分的第一匝(turn);在卷成圈的锚定件的第一端部处连接到中心匝的第二匝,第二匝限定内部空间的宽度小于第一宽度的一部分;以及在卷成圈的锚定件的第二端部处连接到中心匝的第三匝,第三匝限定内部空间的宽度小于第一宽度的另一部分。卷成圈的锚定件可植入在天然二尖瓣处,其中,卷成圈的锚定件的第一匝的至少一部分定位在心脏的左心室中并且围绕天然二尖瓣的瓣膜小叶。
根据本发明的另一实施例,一种用于递送根据上述实施例的植入物的方法包括:在患者心脏的天然二尖瓣处定位卷成圈的锚定件,使得卷成圈的锚定件的第一匝的至少一部分定位在心脏的左心室中并且围绕天然二尖瓣的瓣膜小叶;当支架处于塌缩状态时,穿过卷成圈的锚定件的内部空间将可扩张支架定位在天然二尖瓣处;并且扩张该支架。当所述卷成圈的锚定件未被偏置时,所述支架可扩张到一宽度,该宽度大于由第二匝或第三匝中的至少一个限定的内部空间的宽度,使得支架在第二匝或第三匝中的至少一个上施加径向向外的压力,以增加内部空间的由第二匝或第三匝中的至少一个限定的部分的宽度,同时将内部空间的由第一匝限定的部分的宽度减小到小于第一宽度的宽度。
根据本发明的实施例,通过首先使用螺旋锚定件或卷成圈的锚定件来重塑形状、调整尺寸和/或以其他方式重构天然二尖瓣环,能够更有效地实现患病二尖瓣的修复和/或替换,使得附加的设备和方法能够更容易地或更有效地应用在加强的二尖瓣位置处。
附图说明
根据使用附图的实施例的描述,本发明的进一步特征和优点将变得显而易见。在附图中:
图1示出人心脏的示意性横截面图;
图2示出心脏的二尖瓣环的示意性俯视图;
图3A和图3B分别示出根据本发明的实施例的用于调整天然二尖瓣环的尺寸或重塑天然二尖瓣环的形状的卷成圈的锚定件的透视图和侧视图;
图4A至图4C示意性地示出根据本发明的实施例的在图3A至图3B的卷成圈的锚定件中扩张球囊可扩张支架的步骤;
图5A至图5C示出根据本发明的实施例在天然二尖瓣处植入卷成圈的锚定件和球囊可扩张支架的步骤;
图6A和图6B示出根据本发明的实施例的使用夹具在具有植入支架的二尖瓣上执行边缘到边缘修复的步骤;
图7A和图7B示出根据本发明的实施例在先前执行边缘到边缘修复的天然二尖瓣环处植入人工二尖瓣的步骤;以及
图8示出根据本发明的实施例的完全植入在先前执行边缘到边缘修复的天然二尖瓣处的支架中的人工二尖瓣。
具体实施方式
本文公开用于修复和/或替换天然二尖瓣的功能的各种植入物和其他设备,以及植入此类设备的方法。通过提供此类设备和植入这些设备的方法,能够减少二尖瓣渗漏和由相似类型的瓣膜性心脏病导致的渗漏,并且能够改善二尖瓣的性能。
在某些实施例中,能够使用螺旋锚定件或卷成圈的锚定件来减小和/或重塑天然二尖瓣的环尺寸的形状,为瓣膜修复或进一步的瓣环形成术手术做准备。在其他实施例中,当计划进行瓣膜置换时,螺旋锚定件能够被用于减小患者的天然二尖瓣膜环的尺寸,并使瓣环的形状更适于锚定或对接人工心脏瓣膜。在这些实施例中,能够安装在支架中的各种人工瓣膜中的一种能够与缩窄和/或重塑天然二尖瓣环的形状的螺旋锚定件结合使用。
图3A和图3B示出根据本发明的实施例的螺旋锚定设备或线圈锚定设备的实施例。所示实施例示出了具有三匝的螺旋锚定件10。然而,在其他实施例中,根据特定的应用和患者的解剖结构,其他螺旋锚定件能够具有更多或更少的匝。螺旋锚定件10包括上部第一匝12、中心第二匝14和下部第三匝16,并且限定延伸穿过螺旋锚定件10的中心的空间。锚定件10的上匝12和下匝16小于中心匝14。在一个实施例中,当锚定件10未被偏置时,螺旋的较小的端部匝12、16的直径为大约25mm,而较大的中心匝14的直径为大约35mm。然而,在其他实施例中,匝12、14和16的尺寸能够不同,只要中心匝14大于端部匝12、16。在具有多于三个匝的实施例中,能够将多于一个的中心匝的尺寸设定为大于端部匝,或者在锚定件的任一端部处能够具有多于一个的较小尺寸的匝,或二者皆可。此外,在一些实施例中,锚定件的上匝和下匝彼此能够具有不同的直径。
在一个实施例中,螺旋锚定件10由形状记忆材料诸如镍钛诺制成,这将有助于锚定件10的矫直,以更容易地在患者体内递送。在其他实施例中,锚定件10能够由各种其他生物相容性金属或其他生物相容性材料中的一种制成或包括所述材料中的一种。
此外,螺旋锚定件10的芯材料能够被生物相容性织物或其他生物相容性材料覆盖,以在锚定件10植入患者体内之后改善锚定件10的稳定性、生物相容性或其他功能。此类织物或其他覆盖物也能够用于促进支架和/或人工瓣膜与锚定件10之间的接触或摩擦,以减少锚定件10的扩张,并且使锚定件10抓紧在其内部膨胀或扩张的支架或人工瓣膜,如下面更详细讨论的。
图4A至图4C示意性地示出将球囊可扩张支架***上述卷成圈的锚定件10中的步骤。图4A首先示出支架或人工瓣膜在锚定件内部扩张之前的锚定件10的横截面图。与如上关于图3A和图3B所讨论的相似,锚定件10包括三匝,其中中心匝14具有比端部匝12和16更大的直径。
在图4B中,球囊30***穿过由锚定件10限定的中心空间18,并且然后在螺旋锚定件10内部膨胀至大于锚定件10的端部匝12、16中的至少一个的直径的尺寸。另外,球囊30携带有可扩张支架20,可扩张支架20在球囊30前面穿过锚定件10的中心定位,并且位于球囊30上的支架20扩张,并且支架20撞击或以其他方式与螺旋锚定件10接触。
由于球囊被扩张到大于锚定件10的端部匝12、16的直径的尺寸,所以球囊30和支架20在锚定件10内部的扩张导致两个端部匝12、16的直径增大。例如,在端部匝12、16具有25mm的未偏置直径的情况下,球囊30和支架20能够扩张至高达27mm宽,并且迫使端部匝12、16径向向外,使得端部匝也扩张到大约27mm宽。同时,当两个端部匝12、16扩张时,它们拉动锚定件10的较大的中心匝14的端部,并且反而使较大的中心匝14的直径减小。因此,在球囊30和支架20在锚定件10内部膨胀之后,在一个实施例中,锚定件10的匝全部具有大致相同的直径,该直径在上述示例中为大约27mm。
在支架20已经扩张穿过锚定件10的中心后,能够使球囊30放气并将其移除。图4C示意性地示出在球囊30已经被移除之后,具有扩张穿过其中的支架20的锚定件10的最终配置。支架20通过支架20与锚定件10的匝之间形成的径向压力或摩擦保持在锚定件10中的适当位置中。
图4C中示出的支架20具有织物覆盖物。覆盖物能够覆盖支架20的内部或外部,或者两者。在其他实施例中,支架不包括覆盖物或其他覆盖层。聚酯或各种其他材料中的一种能够用于支架覆盖物。在其他实施例中,也能够使用生物覆盖物,诸如源自动物或人材料的心包膜。
同时,支架20本身能够由如通常用于医疗植入物中的不锈钢或不锈钢的合金制成,或者由各种其他生物相容性金属或其他材料中的一种制成。各种支架设计能够与上述方法中的螺旋锚定件10兼容并与其结合使用。
支架20与螺旋锚定件10的至少较小匝并且/或者与压紧在锚定件10和支架20之间的二尖瓣小叶的下侧之间的摩擦将支架20保持在锚定件10内的适当位置中。此外,较大的中心匝14能够被拉得更接近支架20至其也紧靠支架20的外表面并且对其施加压力的程度。沿这些相同的线,当锚定件10的较小的端部匝12、16在扩张期间保持更牢固地抵靠支架20,并且在这些表面之间的移动或滑动减小时,锚定件10的较大的中心匝14能够被更迅速或更有效地径向向内拉动。因此,改善锚定件10的较小的匝和支架20之间的接触或摩擦的表面涂层和/或其他处理或选项将增加锚定件10的最大匝或多个匝的直径减小的速率,从而导致各部分之间更紧密或更牢固的固定。在一个实施例中,锚定件10中的一个或多个较小的匝具有钩、倒钩或其他附接机构以改善与支架20的接合。
图5A至图5C示出在天然二尖瓣环86处将线圈锚定件10和支架20植入患者心脏80内部的步骤。患有二尖瓣反流或其他二尖瓣渗漏的患者的天然二尖瓣膜环能够被扩大,在一些情况下扩大至大约35mm。不同患病二尖瓣的扩大尺寸能够变化,并且根据患者天然二尖瓣的扩大尺寸或期望尺寸能够利用不同的锚定件和/或支架,以相应地治疗每个特定患病瓣膜。
在图5A中,线圈锚定件10已经例如经由顶端或经中隔手术、血管内或经导管手术,或各种其他已知手术中的一种在心脏内递送。当锚定件10在围绕天然二尖瓣环86的位置中时,锚定件10的两匝,最低的小匝16和中心的较大的匝14位于二尖瓣86下面并且在左心室84内部。同时,上部较小的匝12位于左心房82内部。在其他实施例中,可以基于医师所期望的应用,将匝的不同组合定位在左心房82和左心室84中。
一般来说,螺旋锚定件10的较大匝14能够被选择为与患者的增大的二尖瓣环86的直径相匹配,使得锚定件10能够围绕二尖瓣环86放置,而不在通过其引入支架或人工瓣膜之前对天然二尖瓣小叶88或二尖瓣环86的其他部分施加过度的压力。锚定件10的较小匝12、16能够基于较大匝14所需的缩短量来选择。换句话说,较大的匝14能够基于患病患者中增大的二尖瓣86的尺寸选择,并且较小匝12、16的尺寸能够被选择为指定锚定件10的较大匝14将减小到的期望尺寸,并且从而在植入后大概确定所治疗的二尖瓣环86的期望尺寸。此外,还能够选择卷成圈的锚定件10的匝12、14、16的尺寸和形状,以便于当锚定件10被首次展开时更容易地围绕天然二尖瓣小叶88和/或腱索(未示出)放置和定位锚定件10。
在围绕天然二尖瓣环86将锚定件10定位在期望位置处之后,球囊30用于扩张锚定件10,如图5B所示。与图4B所示类似,球囊30携带并递送可扩张支架20,该可扩张支架20能够被覆盖有覆盖层,如前所述。放气的球囊30和未扩张的支架20首先在由锚定件10限定的空间中移动,直到支架20通过锚定件10定位在期望的位置处。
然后使球囊30膨胀以使支架20扩张,并且这种扩张导致抵靠锚定件10的至少较小的匝12、16施加径向向外的压力。与以上所述相似,球囊30在锚定件10中的膨胀和支架20在锚定件10中的扩张导致锚定件10的最低和最高匝12、16扩张,以及锚定件10的较大中心匝14的直径减小。匝的运动和较大的中心匝14的尺寸/形状的减小量能够基于锚定件10的较小匝12、16与支架20之间的摩擦或保持的量来调节。
从图5B中还可以看出,由于下部匝14、16定位在天然二尖瓣小叶88的外侧,并且支架20在天然二尖瓣环86内扩张,因此瓣膜小叶88被捕获或压紧在锚定件10的下匝14、16和支架20之间的位置中。
在支架20已经在锚定件10中扩张到其最终尺寸之后,能够移除球囊30。在移除球囊30之后,支架20在锚定件10内保持固定在其扩张位置中。
通过经由支架20的扩张减小锚定件10的较大中心匝14的尺寸,天然二尖瓣环86的尺寸也已减小。瓣环86尺寸的这种减小由图5C中的箭头示意性地示出。例如,患者体内的患病或渗漏二尖瓣环的直径在治疗之前可以为35mm,但是在支架20在锚定件10中植入并且扩张之后,锚定件10的中心匝14减小到大约27mm。当锚定件10的较大中心匝14的尺寸减小时,中心匝14迫使天然瓣膜小叶88向内,使得天然二尖瓣环86的尺寸也从大约35mm减小到大约27mm。通过以这种方式使用锚定件10和支架20或其他类型的瓣环成形术环来减小患病的天然二尖瓣膜环86的尺寸和/或来重塑其形状,可以消除或大大减少二尖瓣反流。
其他患者体内的或基于其他疾病的其他二尖瓣环变型能够与具有不同直径组合的锚定件10和/或支架20配对,以针对每个患者和他或她的需要产生最佳效果。在每个实施例中,存在由较小的上匝和下匝包围的一个或多个较大中心匝,其中较大的一个或多个匝用于在***被激活时减小二尖瓣环的直径。
此外,在所述实施例中,在锚定件10中示出了三个完整的匝。然而,也可具有上匝和下匝并非完整匝的锚定件。例如,在替代实施例中,在左心室84中示出的下匝16能够是半个匝,使得在手术结束时,定位于左心室84中的锚定件10少于两匝。在某些实施例中,该手术也能够用仅具有两匝例如一个大匝和一个小匝的锚定件执行。
图5A至图5C中的实施例还示出锚定件10的最高匝12和中心匝14之间的轴向间隙。该间隙能够用于为支架20提供更长的附接长度,使得在植入期间存在用于将支架20定位在其中的更大的目标。锚定件10的较长的长度还能够在植入之后为***提供更多的稳定性。在一些实施例中,较长的锚定件10还能够有助于锚定件10更容易地围绕天然二尖瓣环86初始定位。在其他实施例中,根据需要,锚定件10能够在匝之间具有更大或更小的间隙。在一些实施例中,锚定件在匝之间能够没有间隙。在具有较长锚定件的实施例中,较长锚定件还能够有助于较长支架的植入。较长支架继而能够为稍后的潜在瓣膜植入提供更大的目标。
在一些患者中,即使在已经执行瓣环成形术或其他二尖瓣尺寸调整或重塑形状之后,仍然能够存在一些残余渗漏。在一些情况下,仍然能够采用附加的措施以进一步减少渗漏或以其他方式改善天然二尖瓣的性能。
例如,图6A和图6B示出在期望附加的渗漏减少的带支架的二尖瓣上进行进一步治疗的步骤。图6A示出利用夹具40在二尖瓣小叶88上进行的边缘到边缘修复的开始,以消除或减少在已经植入锚定件10和支架20后的任何残余渗漏。使用各种已知的递送方法和进入部位中的一种,将夹具40例如从左心房82引入左心室84中。夹具40能够由工具50递送,并且定位成使得天然二尖瓣小叶88的端部能够使用夹具40夹紧在一起。夹具40能够包括一个或更多个内夹紧表面42和经由远侧铰链连接的一个或更多个外夹紧表面44。在所示的实施例中,夹具40包括两个内夹紧表面42和两个外夹紧表面44。夹紧表面42、44中的一个或二者能够进一步包括齿或其他表面特征,以有助于通过夹具40更牢固地夹紧二尖瓣小叶88。在其他实施例中,其他夹持或夹紧设备也能够应用于天然二尖瓣小叶88以执行边缘到边缘修复手术。
在图6B中,夹具40已经闭合以将前二尖瓣小叶的自由边缘附接到后二尖瓣小叶的自由边缘。在所示示例中,外夹紧表面44被推向内夹紧表面42以闭合夹具40,并且每个二尖瓣小叶88能够被压紧或夹紧在夹具40的对应的内夹紧表面42和对应的外夹紧表面44之间。在本实施例中,夹具40大致应用于在瓣膜孔的中间(例如,如图7A所示)。在其他实施例中,基于渗漏最严重的位置或者夹具40能够减少大部分渗漏的位置,夹具40能够应用在每个天然二尖瓣小叶88上的各种不同位置中的任何位置处。在某些实施例中,根据需要,可以应用多于一个夹具,以进一步减少通过天然瓣膜的渗漏。
如图6B可见,最终结果与原来的Alfieri类型手术相似,包括由用于重塑天然二尖瓣环的形状的锚定件和/或支架构成的瓣环成形术环和在天然二尖瓣小叶上执行的边缘到边缘修复的组合。以上讨论的顺序被显示为首先执行的瓣环成形术或天然瓣膜重塑形状,以及其后在天然瓣膜小叶上执行的边缘至边缘修复。然而,在其他实施例中,次序能够被颠倒,其中首先应用夹具(即使其与前述手术结合执行),并且然后可以执行瓣环成形术或瓣膜环的其他重塑形状或尺寸调整。在首先执行边缘到边缘修复的手术中,其后递送支架的可膨胀球囊能够受到用于边缘到边缘修复的夹具、夹钳或其他设备的存在的限制。在这些情况下,能够使用具有较短长度的球囊,或者能够将支架定位在球囊上更远侧的位置处,使得球囊不与夹具接触,以防止当球囊膨胀并且支架扩张时夹具受损。也可以具有分叉的或Y形的球囊,使得球囊的分开端部能够围绕夹具进行定位,其中球囊的一部分穿过夹具一侧上的瓣膜开口,并且球囊的另一部分穿过夹具另一侧上的瓣膜开口。例如,参考图7A,分叉球囊的一个端部能够穿过由夹具40形成的天然瓣膜的孔90,而分叉球囊的另一端部能够穿过夹具40的另一侧上的孔92。
在某些情况下,瓣环成形术或天然瓣膜重塑形状和边缘到边缘修复的组合仍不足以抑制二尖瓣反流或其他二尖瓣渗漏。即使在进行了这两个手术之后,患者仍然可在二尖瓣处具有不可接受的渗漏。
图7A、图7B和图8示出以上讨论的锚定件10和/或支架20如何也能够用作用于支架安装的人工瓣膜的理想锚定件。从监管批准和存货的角度来看,具有许多不同的瓣膜形状和尺寸是昂贵的。通过锚定件10和/或支架20减小天然二尖瓣环的尺寸允许使用较小尺寸的人工支架瓣膜。此外,锚定件10和/或支架20帮助重塑天然二尖瓣环的形状成更圆形,使得在二尖瓣位置处能够使用更多具有圆形或圆柱形外轮廓的已经在市场上销售的常规瓣膜。此外,心脏可以能够以更小的环直径而更高效或更有效地在二尖瓣位置处起作用,因为二尖瓣将不会那么大地拉伸开并且能够更完全地收缩。因此,用于将天然二尖瓣环缩小到更均匀的形状和/或尺寸的二尖瓣锚定件或支架能够允许产生较少数量的瓣膜或瓣膜变型,从而节省成本并简化制造和植入手术。
图7A示出二尖瓣环的俯视图,该二尖瓣环已经使用锚定件10和/或支架(未在图7A中示出)经历重塑形状,并且已经使用夹具40经历边缘到边缘手术以夹住天然二尖瓣小叶88的远侧端部。边缘到边缘修复分别在夹具40任一侧上的二尖瓣位置处形成两个孔90、92。在一些患者体内,可不能证明先前的手术足以抑制或减少通过图7A所示的二尖瓣的二尖瓣渗漏。因此,携带安装支架安装的人工瓣膜60的球囊可以进一步通过二尖瓣孔90或92中的一个横跨二尖瓣定位。展开和植入的人工瓣膜60能够是具有适于装配在锚定件10中的尺寸和形状的各种不同的已知瓣膜中的一种,例如Edwards Lifesciences Sapien XTTM瓣膜。
在图7B中,人工瓣膜60例如经由球囊递送***的膨胀而扩张。人工瓣膜60的扩张在天然二尖瓣小叶88上施加了大的径向力或负荷,该天然二尖瓣小叶88在早先的边缘到边缘修复期间预先使用夹具40夹在一起。如图7B所示,人工瓣膜60的扩张开始使夹具40移位并使天然二尖瓣小叶88伸出,并且最终,小叶88中的至少一个从夹具40撕裂下来、从夹具40中滑出,或以其他方式与夹具40分离。
为增进或促进天然二尖瓣小叶88的切割或撕裂,上述瓣膜扩张手术能够在切割天然二尖瓣小叶88的单独球囊在二尖瓣位置处膨胀之后进行。类似的切割球囊已经用于例如切除动脉中的斑块。另一选项能够是切割天然二尖瓣小叶88的至少一个中的缺陷,并且然后在小叶88的预切割部分内部或邻近处推进支架瓣膜。在其他实施例中,其中安装人工二尖瓣的支架能够具有其自己的切割特征,用于切割天然二尖瓣小叶88的周围部分,以进一步有助于人工瓣膜60的扩张。
在某些实施例中,人工瓣膜60能够与夹具40一起从边缘到边缘修复植入从而保持完整。在此情况下,需要确保形成足够尺寸的人工瓣膜60能够定位在其中的孔,以允许足够的流动进入左心室中。如果存在流动阻塞,或者如果孔口尺寸不足,则之后夹具40仍然可以从二尖瓣小叶88的一个边缘被切割,以形成用于人工瓣膜60的更合适的孔或开口。
在某些情况下,夹具40可从两个天然二尖瓣小叶边缘88分离。这将是非常不寻常的,因为这将意味着夹具40在两个小叶上的保持几乎相同。然而,在此类情况下,夹具40能够容易地从患者体内取回和移除。
通常,在天然二尖瓣小叶88中的一个从夹具40撕开或撕裂之后,人工瓣膜自由扩张,直到其紧靠锚定件10和/或支架20。图8示出已经完全展开之后的人工瓣膜60。瓣膜60牢固地位于包括锚定件10和支架20的现有的瓣环成形术装置内。预定位的锚定件10和支架20为人工瓣膜60的***和扩张提供了极好的目标。瓣环成形术装置能够在荧光透视下清楚可见。
如先前讨论的,天然二尖瓣小叶88中的一个已经在裂缝94处撕裂或撕开或以其他方式与夹具40分离,并且天然二尖瓣小叶88的功能已经被人工瓣膜60替换。已经从天然二尖瓣小叶88的一个中分离的夹具40被示出在左心室84内部,并且不应影响人工瓣膜60的功能。
在其他实施例中,基于每个个体患者的需要,也能够组合或修改来自上述不同实施例的各种不同特征。例如,瓣环成形术或二尖瓣环重塑手术不需要结合边缘到边缘手术来执行。相反,瓣环成形术或二尖瓣重塑能够是独立的手术。此外,如果瓣环成形术手术不足以补救患病的心脏,并且渗漏似乎过于严重而不能通过经由边缘到边缘修复植入一个或多个夹具来解决,则也可以直接从瓣环成形术或二尖瓣重塑形状进行到在用于瓣环成形术或二尖瓣重塑形状的锚定件和/或支架内部植入人工二尖瓣。
出于本说明书的目的,本文描述了本公开的实施例的某些方面、优点和新颖特征。所公开的方法、装置和***不应被解释为以任何方式进行限制。相反,本公开涉及各种公开的实施例的所有新颖的和非显而易见的特征和方面,这些特征和方面是单独地,并且彼此呈各种组合和子组合。所述方法、装置和***不限于任何特定方面或特征或其组合,所公开的实施例也不要求呈现任何一个或多个具体优点或解决任何一个或多个具体问题。
尽管为方便呈现以特定有序的次序描述了所公开的实施例中的一些的操作,但是应当理解,这种描述方式包括重新排列,除非由以下阐述的具体语言需要特定排序。例如,在一些情况下,有序描述的操作可以重新排列或同时执行。此外,为简单起见,附图可未示出所公开的方法可以与其他方法结合使用的各种方式。另外,本发明有时使用诸如“提供”或“实现”的术语来描述所公开的方法。这些术语是对所执行的实际操作的高级抽象。对应于这些术语的实际操作可以根据特定实施而变化,并且本领域普通技术人员可以容易地辨别。
考虑到可以应用本公开的原理的许多可能的实施例,应当认识到,所示出的实施例仅是优选的示例,并且不应被视为限制本公开的范围。相反,本公开的范围由所附权利要求限定。
Claims (60)
1.一种用于重塑心脏的天然二尖瓣的形状的植入物,所述植入物包括具有第一端部、第二端部和在所述第一端部与所述第二端部之间延伸的中心轴线的卷成圈的锚定件,其中所述卷成圈的锚定件限定与所述中心轴线同轴的内部空间,并且所述卷成圈的锚定件包括:
第一匝,所述第一匝限定所述内部空间的具有第一宽度的中心部分;
第二匝,所述第二匝在所述卷成圈的锚定件的所述第一端部处连接到所述第一匝,所述第二匝限定所述内部空间的具有小于所述第一宽度的宽度的一部分;以及
第三匝,所述第三匝在所述卷成圈的锚定件的所述第二端部处连接到所述第一匝,所述第三匝限定所述内部空间的具有小于所述第一宽度的宽度的另一部分;
其中所述卷成圈的锚定件可植入在所述天然二尖瓣处,其中所述卷成圈的锚定件的所述第一匝的至少一部分定位在所述心脏的左心室中并且围绕所述天然二尖瓣的瓣膜小叶;
其中所述第一匝、所述第二匝和所述第三匝被配置成使得当径向向外的压力被施加到所述卷成圈的锚定件的所述第二匝或所述第三匝中的至少一个时,所述卷成圈的锚定件可调节到其中所述内部空间的由所述第一匝限定的所述部分具有小于所述第一宽度的宽度的位置,并且其中所述内部空间的由所述第一匝、所述第二匝和所述第三匝限定的宽度基本上相等。
2.根据权利要求1所述的植入物,其中所述卷成圈的锚定件包括形状记忆材料。
3.根据权利要求1到2中的一项所述的植入物,其中所述植入物还包括:
不具有小叶的可扩张的支架,所述可扩张的支架被配置为在所述天然二尖瓣处在所述卷成圈的锚定件的所述内部空间中被扩张,使得所述卷成圈的锚定件和所述可扩张的支架相互作用以减小所述天然二尖瓣的尺寸并减少通过所述天然瓣膜小叶的二尖瓣反流;和
人工瓣膜,所述人工瓣膜包括可扩张框架并且容纳用于控制流经其中的血液的多个小叶,其中当所述支架被扩张时,所述人工瓣膜可扩张到至少为所述支架的宽度的宽度,使得所述人工瓣膜被配置为被保持在所述支架中。
4.根据权利要求3所述的植入物,其中所述支架的可扩张框架的外表面包括用于切割天然组织的至少一个切割特征。
5.根据权利要求3所述的植入物,其中所述人工瓣膜的所述可扩张框架的外表面包括用于切割天然组织的至少一个切割特征。
6.一种用于心脏的天然二尖瓣的植入物,所述植入物包括卷成圈的锚定件,所述卷成圈的锚定件包括:
限定上匝直径的上匝;
连接到所述上匝的中心匝,中心匝限定中心匝直径,所述中心匝直径大于由所述上匝限定的所述上匝直径;和
连接到所述中心匝的下匝,所述下匝限定小于所述中心匝直径的下匝直径;
其中所述卷成圈的锚定件被配置为被植入在所述天然二尖瓣处,其中所述卷成圈的锚定件的所述中心匝的至少一部分定位在所述心脏的左心室中并且围绕所述天然二尖瓣的瓣膜小叶;
其中所述中心匝、所述上匝和所述下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,所述卷成圈的锚定件被偏置使得所述中心匝直径被减小,并且所述中心匝直径、所述上匝直径和所述下匝直径变得基本上相等。
7.根据权利要求6所述的植入物,其还包括支架,所述支架包括可扩张框架,所述可扩张框架被配置为在由所述卷成圈的锚定件的所述上匝、所述中心匝和所述下匝限定的内部空间中被扩张。
8.根据权利要求7所述的植入物,其中当所述卷成圈的锚定件未被偏置时,所述支架可扩张到大于所述上匝直径或所述下匝直径的直径。
9.根据权利要求7到8中的一项所述的植入物,其中所述支架被覆盖层覆盖。
10.根据权利要求7到8中的一项所述的植入物,其中所述卷成圈的锚定件的所述上匝和所述下匝中的至少一个被配置为附接到所述支架的外表面。
11.根据权利要求7到8中的一项所述的植入物,其还包括夹具,所述夹具被配置为将所述天然二尖瓣的所述瓣膜小叶的相应端部保持在一起。
12.根据权利要求11所述的植入物,其还包括人工瓣膜,所述人工瓣膜包括可扩张框架,所述可扩张框架容纳用于控制流经其中的血液的多个小叶,其中当所述支架被扩张时,所述人工瓣膜可扩张到至少为所述支架的直径的直径,使得所述人工瓣膜被配置为被保持在所述支架中。
13.根据权利要求12所述的植入物,其中所述人工瓣膜的所述可扩张框架的外表面包括至少一个切割特征,其中所述切割特征包括被配置为切割天然二尖瓣的部分的表面。
14.根据权利要求7所述的植入物,其还包括人工瓣膜,所述人工瓣膜包括可扩张框架,所述可扩张框架容纳用于控制流经其中的血液的多个小叶,其中当所述支架被扩张时,所述人工瓣膜可扩张到至少为所述支架的直径的直径,使得所述人工瓣膜被配置为被保持在所述支架中。
15.一种用于心脏的天然二尖瓣的植入物,所述植入物包括卷成圈的锚定件,所述卷成圈的锚定件包括:
限定大约25mm的上匝直径的上匝;
连接到所述上匝的中心匝,所述中心匝限定大约35mm的中心匝直径;和
连接到所述中心匝的下匝,所述下匝限定大约25mm的下匝直径;
其中所述卷成圈的锚定件被配置为被植入在所述天然二尖瓣处,其中所述卷成圈的锚定件的所述中心匝的至少一部分定位在所述心脏的左心室中并且围绕所述天然二尖瓣的瓣膜小叶。
16.根据权利要求15所述的植入物,其中所述中心匝、所述上匝和所述下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,所述中心匝直径被减小并且所述中心匝直径、所述上匝直径和所述下匝直径变得基本上相等。
17.根据权利要求15到16中的一项所述的植入物,其还包括支架,所述支架包括可扩张框架,所述可扩张框架被配置为在由所述卷成圈的锚定件的所述上匝、所述中心匝和所述下匝限定的内部空间中被扩张。
18.根据权利要求17所述的植入物,其中所述支架可扩张到大于25mm的直径。
19.根据权利要求17所述的植入物,其中所述支架被覆盖层覆盖。
20.根据权利要求17所述的植入物,其中所述卷成圈的锚定件的所述上匝和所述下匝中的至少一个被配置为附接到所述支架的外表面。
21.根据权利要求17所述的植入物,其还包括人工瓣膜,所述人工瓣膜包括可扩张框架,所述可扩张框架容纳用于控制流经其中的血液的多个小叶,其中当所述支架被扩张时,所述人工瓣膜可扩张到至少为所述支架的直径的直径,使得所述人工瓣膜被配置为被保持在所述支架中。
22.根据权利要求21所述的植入物,其中所述人工瓣膜的所述可扩张框架的外表面包括至少一个切割特征,其中所述切割特征包括被配置为切割天然二尖瓣的部分的表面。
23.根据权利要求17所述的植入物,其还包括人工瓣膜,所述人工瓣膜包括可扩张框架并且容纳用于控制流经其中的血液的多个小叶,其中当所述支架被扩张时,所述人工瓣膜可扩张到至少为所述支架的直径的直径,使得所述人工瓣膜被配置为被保持在所述支架中。
24.一种用于天然瓣膜的***,其包括:
卷成圈的植入物;和
人工瓣膜;
其中所述卷成圈的植入物包括:
具有上匝直径的上匝;
连接到所述上匝的中心匝,所述中心匝限定中心匝直径,所述中心匝直径大于所述上匝直径;和
连接到所述中心匝的下匝,所述下匝限定小于所述中心匝直径的下匝直径;并且
其中所述人工瓣膜包括:
可扩张框架,其可扩张到最大扩张直径,和
设置在所述可扩张框架内的多个小叶,用于控制通过所述人工瓣膜的血流;
其中所述卷成圈的植入物被配置为可植入在所述天然瓣膜处,其中所述卷成圈的植入物的所述中心匝的至少一部分定位在心脏的心室中并且围绕所述天然瓣膜的瓣膜小叶,并且
其中所述中心匝、所述上匝和所述下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,所述中心匝直径被减小到减小直径,并且所述中心匝直径、所述上匝直径和所述下匝直径变得基本上等于所述减小直径,并且所述人工瓣膜的所述最大扩张直径至少与所述减小直径相同或者大于所述减小直径。
25.根据权利要求24所述的***,其中所述卷成圈的植入物的所述上匝和所述下匝中的至少一个被配置为附接到所述人工瓣膜的外表面。
26.一种用于重塑心脏的天然瓣膜的形状的植入物,所述植入物包括:
具有第一端部、第二端部和在所述第一端部与所述第二端部之间延伸的中心轴线的卷成圈的锚定件;
其中当未被偏置时,所述卷成圈的锚定件限定与所述中心轴线同轴的内部空间,并且所述卷成圈的锚定件包括:
第一匝,所述第一匝限定所述内部空间的具有第一宽度的中心部分,
第二匝,所述第二匝在所述卷成圈的锚定件的所述第一端部处连接到所述第一匝并且限定所述内部空间的具有小于所述第一宽度的第二宽度的一部分,以及
第三匝,所述第三匝在所述卷成圈的锚定件的所述第二端部处连接到所述第一匝并且限定所述内部空间的具有小于所述第一宽度的第三宽度的另一部分;和
支架,其包括可扩张框架;
其中所述卷成圈的锚定件被配置为被植入在所述天然瓣膜处,其中所述卷成圈的锚定件的所述中心匝的至少一部分定位在所述心脏的心室中并且围绕所述天然瓣膜的瓣膜小叶;
其中所述支架在所述卷成圈的锚定件的所述内部空间内扩张到大于所述第二宽度和所述第三宽度中的至少一个的第四宽度,使得通过所述支架将径向向外的压力施加到所述第二匝和所述第三匝上,使得所述内部空间的由所述第二匝限定的部分宽于所述第二宽度,并且所述内部空间的由所述第三匝限定的部分宽于所述第三宽度,同时所述内部空间的由所述第一匝限定的部分被减小到小于所述第一宽度的宽度。
27.根据权利要求26所述的植入物,其中所述内部空间的由所述第一匝、所述第二匝和所述第三匝限定的相应部分的宽度基本上彼此相等。
28.根据权利要求26到27中的一项所述的植入物,其还包括:
人工瓣膜,所述人工瓣膜包括可扩张框架并且容纳多个小叶,所述人工瓣膜被扩张到至少为扩张的支架的宽度的宽度,使得通过所述人工瓣膜的所述框架将径向向外的压力施加到所述支架上以将所述人工瓣膜保持在所述支架中。
29.根据权利要求26到27中的一项所述的植入物,其中所述支架容纳用于控制流经其中的血液的多个瓣膜小叶。
30.根据权利要求26到27中的一项所述的植入物,其中:
所述支架的所述可扩张框架还包括用于切割天然组织的至少一个切割特征。
31.根据权利要求28所述的植入物,其中:
所述人工瓣膜的所述可扩张框架还包括用于切割天然组织的至少一个切割特征。
32.根据权利要求26到27中的一项所述的植入物,其中:
所述第一宽度大约为25mm;
所述第二宽度大约为35mm;并且
所述第三宽度大约为25mm。
33.一种用于天然二尖瓣的***,其包括:
卷成圈的植入物;和
包括可扩张框架的支架;
其中所述卷成圈的植入物包括:
具有上匝直径的上匝,
连接到所述上匝的中心匝,所述中心匝限定中心匝直径,所述中心匝直径大于所述上匝直径,和
连接到所述中心匝的下匝,所述下匝限定小于所述中心匝直径的下匝直径;并且
其中所述卷成圈的植入物被配置为可植入在所述天然二尖瓣处,其中所述卷成圈的植入物的所述中心匝的至少一部分定位在心脏的左心室中并且围绕所述天然二尖瓣的瓣膜小叶,并且
其中所述支架被配置为在由所述卷成圈的植入物的所述上匝、所述中心匝和所述下匝限定的内部空间中扩张;
其中所述中心匝、所述上匝和所述下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,所述中心匝直径被减小到减小直径。
34.根据权利要求33所述的***,其中所述中心匝直径、所述上匝直径和所述下匝直径变得基本上等于所述减小直径。
35.根据权利要求33到34中的一项所述的***,所述支架的最大扩张直径至少与所述减小直径相同或者大于所述减小直径。
36.根据权利要求33到34中的一项所述的***,所述***还包括可膨胀球囊,其中所述可膨胀球囊被配置为扩张所述支架的所述可扩张框架。
37.根据权利要求36所述的***,其中所述可膨胀球囊被配置为被膨胀使得所述可膨胀球囊不与附接到所述天然二尖瓣的所述瓣膜小叶中的一个或多个的一个或多个夹具接触。
38.根据权利要求37所述的***,其中所述可膨胀球囊具有比所述支架的长度更短的长度以避免与所述一个或多个夹具接触。
39.根据权利要求37所述的***,其中所述支架被配置为定位在所述可膨胀球囊上的较远侧位置处以避免与所述一个或多个夹具接触。
40.根据权利要求37所述的***,其中所述可膨胀球囊被分叉并且被配置为使得所述可膨胀球囊的第一部分能够穿过由所述一个或多个夹具形成的所述天然瓣膜的第一孔,并且所述可膨胀球囊的第二部分能够穿过由所述一个或多个夹具形成的所述天然瓣膜的第二孔。
41.根据权利要求33到34中的一项所述的***,其中所述支架被覆盖层覆盖。
42.根据权利要求33到34中的一项所述的***,其中所述卷成圈的植入物的所述上匝和所述下匝中的至少一个被配置为附接到所述支架的外表面。
43.根据权利要求33到34中的一项所述的***,其中:
所述第一宽度大约为25mm;
所述第二宽度大约为35mm;并且
所述第三宽度大约为25mm。
44.根据权利要求33到34中的一项所述的***,其中所述支架可扩张到大于25mm的直径。
45.一种***,其包括:
包括多个匝的卷成圈的植入物;和
可扩张框架,其中所述可扩张框架的外表面包括用于切割天然组织的至少一个切割特征。
46.根据权利要求45所述的***,其中所述卷成圈的植入物被配置为可植入在天然瓣膜处,其中所述卷成圈的植入物的中心匝的至少一部分定位在心脏的心室中并且围绕所述天然瓣膜的瓣膜小叶。
47.根据权利要求45所述的***,其中所述卷成圈的植入物的所述多个匝的中心匝、上匝和下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,中心匝直径被减小到减小直径,并且所述中心匝直径、上匝直径和下匝直径变得基本上等于所述减小直径。
48.根据权利要求47所述的***,其中所述可扩张框架的最大扩张直径至少与所述减小直径相同或者大于所述减小直径。
49.根据权利要求47所述的***,其中所述卷成圈的锚定件的所述上匝和所述下匝中的至少一个被配置为附接到所述人工瓣膜的外表面。
50.根据权利要求45所述的***,其中所述可扩张框架形成人工瓣膜的一部分,并且所述人工瓣膜还包括设置在所述可扩张框架内的多个小叶,用于控制通过所述人工瓣膜的血流。
51.一种***,其包括:
卷成圈的植入物;和
包括可扩张框架的支架;和
可膨胀球囊;
其中所述卷成圈的植入物包括多个匝并且被配置为可植入在天然瓣膜处,其中所述卷成圈的植入物的中心匝的至少一部分定位在心脏的心室中并且围绕所述天然瓣膜的瓣膜小叶;
其中所述支架被配置为在所述卷成圈的植入物的内部空间中扩张;
其中所述可膨胀球囊被配置为被膨胀使得所述可膨胀球囊扩张所述可扩张框架而不与附接到所述天然瓣膜的所述瓣膜小叶中的一个或多个的一个或多个夹具接触。
52.根据权利要求51所述的***,其中所述可膨胀球囊具有比所述支架的长度更短的长度以避免与所述一个或多个夹具接触。
53.根据权利要求51所述的***,其中所述支架被配置为定位在所述可膨胀球囊上的较远侧位置处以避免与所述一个或多个夹具接触。
54.根据权利要求51所述的***,其中所述可膨胀球囊被分叉并且被配置为使得所述可膨胀球囊的第一部分能够穿过由所述一个或多个夹具形成的所述天然瓣膜的第一孔,并且所述可膨胀球囊的第二部分能够穿过由所述一个或多个夹具形成的所述天然瓣膜的第二孔。
55.根据权利要求51-54中的一项所述的***,其中所述卷成圈的植入物包括:
具有上匝直径的上匝,
连接到所述上匝的中心匝,所述中心匝限定中心匝直径,所述中心匝直径大于所述上匝直径,和
连接到所述中心匝的下匝,所述下匝限定小于所述中心匝直径的下匝直径。
56.根据权利要求55所述的***,其中所述内部空间由所述卷成圈的植入物的所述上匝、所述中心匝和所述下匝限定。
57.根据权利要求55所述的***,其中所述中心匝、所述上匝和所述下匝被配置成使得当径向向外的压力被施加到所述上匝或所述下匝中的至少一个时,所述中心匝直径被减小到减小直径。
58.根据权利要求57所述的***,其中所述中心匝直径、所述上匝直径和所述下匝直径变得基本上等于所述减小直径。
59.根据权利要求58所述的***,其中所述支架的最大扩张直径至少与所述减小直径相同或者大于所述减小直径。
60.根据权利要求55所述的***,其中所述卷成圈的植入物的所述上匝和所述下匝中的至少一个被配置为附接到所述支架的外表面。
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CN106604699B (zh) | 2019-05-03 |
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CA3185079A1 (en) | 2016-03-17 |
US20240225821A1 (en) | 2024-07-11 |
CN106604699A (zh) | 2017-04-26 |
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