CN102573703A - 经导管瓣膜输送系统和方法 - Google Patents
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Abstract
用于将假体瓣膜经皮输送至病人心脏的输送装置和方法。这些假体瓣膜可构造成提供促进将假体瓣膜最佳地放置到诸如主动脉瓣、二尖瓣、肺动脉瓣和/或三尖瓣的天然心脏瓣膜内的互补特征。输送装置包括容纳于外输送套管(52)内的释放套管(154)组件。该组件的释放套管部件将假体瓣膜(32)的一部分捕获至输送装置,并实现在外套管缩回时假体瓣膜的完全释放。
Description
相关申请的交叉引用
本申请根据35U.S.C.119(e)(1)要求2009年8月27日提交的、题为“经导管瓣膜输送系统和方法”美国临时专利申请序列号第61/237,373号(代理机构案卷号P0035291.00)的优先权;且该申请的全部内容以参见方式纳入本文。
技术领域
本发明涉及用于植入经导管瓣膜的输送系统。更具体地,本发明涉及经皮植入假体心脏瓣膜的输送系统和方法。
背景
病变或者有缺陷的心脏瓣膜可使用各种不同类型的心脏瓣膜手术来修复或置换。一种常见类型的心脏瓣膜手术是在普通麻醉下进行的开放式心脏手术过程,在此过程中心脏停止且血流由心肺旁路机来控制。这种类型的瓣膜手术是高度侵入性的,并且会将病人暴露于多种潜在的风险中,诸如感染、中风、肾衰竭以及例如与心肺旁路机的使用相关的不利作用。
由于开放式心脏手术过程的缺点,越来越感兴趣的是心瓣膜的最小侵入性和经皮置换。这种手术技术涉及在病人皮肤内造成相对较小的开口,瓣膜组件插入该开口并经由类似于导管的输送装置输送到心脏。这种技术经常对于诸如上述开放式心脏手术过程的侵入性较大的手术形式是较佳的。
假体心脏瓣膜的各种类型和构造用于经皮瓣膜过程以置换病变的天然人体心脏瓣膜。任何特定的假体心脏瓣膜的实际形状和构造在一定程度上取决于被置换的瓣膜(即,二尖瓣、三尖瓣、主动脉瓣或肺动脉瓣)。一般来说,假体心脏瓣膜的设计试图复制被置换的瓣膜功能,并因此将包括与生物假体或机械心脏瓣膜假体一起使用的瓣膜小叶状结构。如果选择生物假体,则置换瓣膜可包括带瓣膜的静脉段,该静脉段以某种方式安装于可扩张支架框内以制成带瓣膜的支架。为了制备这种用于经皮植入的瓣膜,一种类型的带瓣膜的支架起初可设置在已扩张或未褶缩状况下,然后已褶缩或压缩在导管的气囊部周围,直至带瓣膜的支架尽可能接近导管的直径。在其它经皮植入系统中,带瓣膜支架的支架框可由自扩张材料制成。借助于这些系统,带瓣膜的支架褶缩到期望的尺寸,并例如用套管保持在该压缩状态。使套管从该带瓣膜的支架缩回允许支架在例如处于病人内期望位置时扩张到较大的直径。借助于这些类型的经皮支架输送系统,通常不必以传统方式将假体心脏瓣膜缝合至病人天然组织。
尽管经皮瓣膜置换技术和装置已有进步,但一直希望提供不同的输送系统,这些输送系统用于以侵入性最小和经皮的方式将心瓣膜输送到植入位点。还始终希望一旦瓣膜已展开或局部展开就能重新定位瓣膜和/或使其缩回,以确保瓣膜最佳地放置于病人内。此外,希望提供一种瓣膜和对应的输送系统,该瓣膜和输送系统使瓣膜易于加载到输送系统上并允许在瓣膜处于病人内期望位置时有效地释放瓣膜。
概述
本发明的输送装置可用于将置换瓣膜输送到病人心脏。这些置换心脏瓣膜可构造成提供促进将置换心脏瓣膜最佳地放置到诸如主动脉瓣、二尖瓣、肺动脉瓣和/或三尖瓣的天然心脏瓣膜内的互补特征。在一些实施例中,本发明的置换心脏瓣膜极经得起使用逆行经动脉方法的经血管输送。与本发明相关的方法可重复多次,以使本发明的若干假体心脏瓣膜如有必要或如期望地能彼此叠置、相邻安装或者安装于彼此内部。
用于插入本发明的置换心脏瓣膜的方法包括输送装置,这些输送装置能在它们的插入过程中将支架结构保持在它们被压缩的状态并且一旦支架结构处于期望的位置就允许或引起支架结构扩张。此外,本发明的输送方法可包括这样的特征,即,允许在支架已从支架输送装置至少部分地展开之后取回支架,以移出支架或者将它们重新定位。该方法可包括使用顺行或逆行方法来植入支架结构。此外,在本发明的许多输送方法中,支架结构可在活的有机体内转动以允许支架结构在病人内调节到期望的定向。
根据本发明原理的一些方面涉及一种用于经皮部署带支架假体心脏瓣膜的输送装置,该带支架假体心脏瓣膜此外包括瓣膜结构所附连至的支架框。输送装置包括输送套管组件、内轴组件、毂和释放套管组件。输送套管组件终止于远侧端部并形成内腔。内轴可滑动地设置在该内腔内。毂从内轴突出并构造成可释放地接纳假体心脏瓣膜支架框的一部分,诸如由支架框形成的一个或多个支柱。释放套管组件沿输送套管组件和内轴来设置。在此方面,释放套管组件包括可滑动地围绕内轴设置的释放套管。借助于此构造,输送装置构造成提供加载状态和展开状态。在加载状态下,输送套管组件将带支架假体心脏瓣膜保持在内轴上。此外,带支架假体心脏瓣膜经由释放套管联接至毂。在展开状态下,输送套管组件的远侧端部从假体心脏瓣膜撤去,如释放套管一样。在展开状态下,然后,允许假体心脏瓣膜从毂释放。在一些实施例中,释放套管组件构造成使释放套管相对于毂自缩回,而输送套管组件朝近侧缩回。在其它实施例中,释放套管组件还包括通过至少一个偏置构件连接至释放套管的安装基部,该偏置构件可以是板簧状本体。借助于这些构造,安装基部固定至位于毂近侧的内轴;当用输送套管组件的内腔来限制偏置构件时,偏置构件受迫成挠曲状态,从而引导毂上的释放套管。当偏置构件从输送套管组件的范围释放时,偏置构件自过渡到正常状态,由此使释放套管缩回。
根据本发明原理的还有其它方面涉及一种用于置换病人的有缺陷的心脏瓣膜的系统。该系统包括如上所述的假体心脏瓣膜和输送装置。假体心脏瓣膜包括支架框和附连于该支架框的瓣膜结构。支架框限定远侧区域和近侧区域,近侧区域形成至少一个支柱。在系统的加载状况下,支柱捕获于释放套管与毂之间。当输送套管组件的远侧端部朝近侧超出释放套管缩回时,释放套管组件使释放套管自缩回,由此允许支柱从毂释放。
根据本发明的原理的还有其它方面涉及将带支架假体心脏瓣膜经皮部署到病人的植入位点的方法。加载有可径向扩张的假体心脏瓣膜的输送装置被接纳,该假体心脏瓣膜具有支架框和瓣膜结构。输送装置包括输送套管组件,在装置的加载状态下该输送套管组件包含以压缩构造位于内轴上的假体心脏瓣膜。输送装置还包括从内轴突出的毂和包括释放套管的释放套管组件,该释放套管将支架框的支柱可滑动地捕获至毂。在加载状态下,处于压缩构造的假体心脏瓣膜经由输送装置输送通过所述病人的人体内腔并输送至植入位点。输送套管组件从假体心脏瓣膜朝近侧缩回。最后,允许支柱在实现完全展开时从毂释放,这包括释放套管组件使释放套管相对于毂自缩回。
附图简介
借助于附图将进一步阐释本发明,其中在几个视图中,类似的结构用类似的附图标记表示,且其中:
图1A是可用于本发明的系统和方法的、并处于正常扩张构造的带支架假体心脏瓣膜的侧视图;
图1B是处于压缩构造的图1A的假体心脏瓣膜的侧视图;
图2A是根据本发明原理的带支架假体心脏瓣膜输送装置的分解立体图;
图2B是最终组装时图2A的输送装置的侧视图;
图3A是可用于图2A的输送装置的毂部件的侧视图;
图3B是图3A的毂的端视图;
图3C是图3A的毂的剖视图;
图4是可用于图2A的输送装置的毂的另一实施例的侧视图;
图5是图2A的输送装置的释放套管组件部件的一部分的立体图;
图6A是图2A的并处于正常状态的输送装置的释放套管组件部件的侧视图;
图6B是图6A的并处于压缩或挠曲状态的释放套管组件的侧视图;
图7是根据本发明的心瓣膜置换系统的一部分的剖视图,该部分包括加载有图1B的假体心瓣膜的图2A的输送装置;
图8A是处于局部展开状态的图7的系统的远侧部的侧视图;
图8B示出病人解剖体内的图8A的系统的输送,其包括带支架的假体心脏瓣膜的局部展开;
图9A是在展开的后续另一阶段中的图2A的输送装置的简化立体图;
图9B是在局部展开的后续另一状态下的图7的系统的侧视图;
图10A和10B是在过渡到展开状态的各种阶段中的图2A的输送装置的简化立体图;
图11A是在展开状态下的图7的系统的一部分的侧视图;以及
图11B以简化的形式示出图7的系统相对于病人解剖体的位置,包括假体心脏瓣膜从输送装置的完全展开和至天然瓣膜的植入。
详述
如在此所提及地,用于各种系统和/或作为各种系统的一部分的支架经导管假体心瓣膜或本发明的方法可呈现各种不同的构造,诸如具有组织小叶的生物假体心瓣膜或具有聚合物、金属或组织工程设计的小叶的合成心瓣膜,并可为置换任何心瓣膜而专门构造。因此,可用于本发明的系统、装置和方法的带支架假体心脏瓣膜一般可用于置换天然大动脉瓣、二尖瓣、肺动脉瓣或三尖瓣,用作为静脉瓣,或者用于置换诸如在主动脉瓣或二尖瓣之类的区域内的失效生物假体。
一般来说,本发明的带支架假体心脏瓣膜包括保持瓣膜结构(组织或合成物)的支架或支架框,支架具有正常的可扩展构造并可坍缩到压缩构造以加载到输送装置内。支架通常构造成在从输送装置释放时自展开或自扩张。例如,可用于本发明的带支架假体心脏瓣膜可以是可由麦德托尼克CoreValve有限公司(Medtronic CoreValve,LLC)购得的、商标名为CoreValve的假体瓣膜。在美国专利申请第2006/0265056号、第2007/0239266号和第2007/0239269号中描述了可用于本发明的系统、装置和方法的经导管心脏瓣膜假体的其它非限制性示例,这些申请的内容以参见方式纳入本文。支架或支架框是支承结构,这些支承结构包括相对于彼此设置的多个支架或线材部,以向假体心脏瓣膜提供期望的可压缩性和强度。概括来说,本发明的支架或支架框是大体管状的支承结构,这些支承结构具有瓣膜结构小叶将固定于其中的内部区域。小叶可由多种材料制成,诸如自体同源组织、异种移植组织或本领域已知的合成物。小叶可设置成均质的生物瓣膜结构,诸如猪、牛、马瓣膜。替代地,小叶可彼此独立地设置(例如牛或马心包小叶)并随后组装至支架框的支承结构。在另一替代方式中,支架框和小叶可同时制造,诸如可使用例如在先进生物假体表面公司(Advance BioProsthetic Surfaces(ABPS))生产的高强度纳米制造的NiTi膜来完成。支架框支承结构一般构造成容纳至少两个(典型为三个)小叶,然而,在此所述类型的支架假体心瓣膜可包含多于或少于三个小叶。
支架框的一些实施例可以是一系列线材或线材段,它们设置成能够从压缩或坍缩构造自过渡到正常的径向扩张构造。在一些构造中,包括支架框支承结构的许多单独的线材可由金属或其它材料制成。这些线材设置成支架框支承结构允许折叠或压缩或褶缩到压缩构造,在此构造中内径小于处于正常的扩张构造下的内径。在压缩构造下,这种具有附连的瓣膜小叶的支架框支承结构可安装到输送装置上。支架框支承结构构造成它们能在期望时诸如通过一个或多个外套管相对于支架框长度的相对运动变化到它们正常的扩张构造。
本发明的实施例中的支架框支承结构的线材可由诸如镍钛合金(例如,镍钛诺TM)的形状记忆材料制成。借助于此材料,支承结构可诸如通过施加热量、能量等或者通过去除外力(例如,压缩力)从压缩构造自扩张到正常的扩张构造。这种支架框支承结构还可多次压缩和再膨胀,而不会破坏支架框的结构。此外,这种实施例的支架框支承结构可由单件材料激光切割出或者由许多不同的部件组装而成。对于这些类型的支架框结构,可使用的输送装置的一个示例包括具有可缩回套管的导管,该套管覆盖支架框直至支架框展开为止,在此位置,套管可缩回以允许支架框自扩张。下文讨论这种实施例的进一步细节。
考虑到上述内容,在图1A中示出可用于本发明的系统、装置和方法的带支架假体心脏瓣膜30的一个非限制性示例。作为参考,假体心脏瓣膜30在图1A的视图中示出为处于正常或扩张构造;图1B示出处于压缩构造的假体心脏瓣膜30(例如,当压缩性地保持在外导管或套管内)。假体心脏瓣膜30包括支架或支架框32以及瓣膜结构34。支架框32可呈上述形式的任一种,并一般构造成从压缩构造(图1B)自扩张到正常的扩张构造(图1A)。在其它实施例中,支架框32可通过单独的装置(例如,位于支架框32内部的气囊)扩张到扩张构造。瓣膜结构34组装到支架框32并提供两个或更多个(通常为三个)小叶36。瓣膜结构34可呈上述形式的任一种,并能以各种方式组装到支架框32,诸如通过将瓣膜结构34缝合到由支架框32形成的线材段中的一个或多个。
借助于图1A和1B的唯一可接受构造,假体心脏瓣膜30构造成置换或修复主动脉瓣。替代地,还可设想其它形状,即这些形状适用于待修复的瓣膜的特定解剖体(例如,根据本发明的带支架假体心脏瓣膜可为了置换天然二尖瓣、肺动脉瓣或三尖瓣来成形和/或设计尺寸)。借助于图1A和1B的一个构造,瓣膜结构34延伸小于支架框32的整个长度,但在其它实施例中可沿支架框32的整个长度或几乎整个长度延伸。多种其它构造也可接受并在本发明的范围内。例如,支架框32可具有处于正常扩张构造下的更圆柱形的形状。
借助于对假体心脏瓣膜30的上述理解,在图2A和2B中示出了用于经皮输送假体30的输送装置50的一个实施例。尽管装置50可加载有用于输送该装置的带支架瓣膜,但这种带支架瓣膜未在图2A和2B中示出,以更清楚地说明输送装置50的各部件。输送装置50包括输送套管组件52、内轴组件54、保持本体或毂56、释放套管组件58和手柄60。下文提供各种部件的细节。然而,一般来说,输送装置50与带支架假体心脏瓣膜(未示出)结合以形成用于修复病人的有缺陷的心脏瓣膜的系统。输送装置50提供这样一种加载状态,即,带支架假体心脏瓣膜经由毂56联接到内轴组件54,并压缩性地保持在输送套管组件52的囊62内。输送套管组件52可被操纵成经由手柄60的操作朝近侧从假体心脏瓣膜撤去囊62,从而允许假体自扩张并从内轴组件54释放。释放套管组件58操作成实现这种释放。此外,手柄60可操作成操纵囊62以实现局部展开的状态,在此状态下,允许假体心脏瓣膜的远侧区域自扩张,而假体的近侧区域保持与毂56相联接。
在图2A和2B中反映并且下文描述的部件52-60的各种特征可作修改或用不同的结构和/或机构来更换。因此,本发明决不限于如下所示和所述的输送套管组件52、内轴组件54、毂56、手柄60等。更具体地,根据本发明的输送装置提供能压缩性地保持自展开的带支架假体心脏瓣膜的特征(例如,囊62与毂56/释放套管组件58结合)以及能实现假体的局部和完全释放或展开的机构(例如,使囊62与释放套管组件58一起缩回)。
在一些实施例中,输送套管组件52包括囊62和轴70,并限定近侧端部和远侧端部72、74。内腔76由输送套管组件52形成,从而从远侧端部74通过囊62与轴70的至少一部分延伸。内腔76能在近侧端部72处具有开口。囊62从轴70朝远侧延伸,并在一些实施例中具有更硬的构造(与轴70的硬度相比),该构造具有足够的径向或周向刚度以在压缩于囊62内时明显抵抗带支架假体心脏瓣膜(未示出)的预期的扩张力。例如,轴70可以是嵌有金属编织物的聚合物管,而囊62包括可选择地嵌入聚合物覆盖物的激光切割的金属管。替代地,囊62和轴70可具有更均匀的构造(例如,连续聚合物管)。无论如何,囊62构造成当带支架假体心脏瓣膜加载于囊62内时压缩性地将其保持于预定的直径,且轴70用于使囊62与手柄60连接。轴70(以及囊62)构造成有足够的挠性以穿过病人的脉管系统,又具有足够的纵向硬度以实现囊62的期望的轴向运动。换言之,轴70朝近侧的缩回直接传递到囊62并引起囊62对应地朝近侧缩回。在其它实施例中,轴70进一步构造成将转动力或运动传递到囊62上。
内轴组件54可具有适于支承囊62内的带支架假体心脏瓣膜的各种构造。在一些实施例中,内轴组件54包括内支承轴80和尖端82。内支承轴80的尺寸设计成可滑动地接纳于输送套管组件52的内腔76内,并构造成安装毂56和释放套管组件58。内支承轴80可包括远侧段84和近侧段86。远侧段84将尖端82连接至近侧段86,而近侧段86又使内部轴组件54与手柄58相联接。部件80-86可结合以形成连续内腔88(总地标记),该内腔的尺寸设计成可滑动地接纳诸如引导线(未示出)的辅助部件。
远侧段84可以是嵌有金属编织物的挠性聚合物管。其它构造也可接受,只要远侧段84具有足以支承加载的、被压缩的带支架假体心脏瓣膜(未示出)以及与安装至假体心脏瓣膜的毂56和释放套管组件58的结构整体性。近侧段86可在一些构造中包括前部90和尾部92。前部90用作远侧段和近侧段84、86之间的过渡,并因此在一些实施例中是挠性聚合物管件(例如,PEEK),该管件的外径略小于远侧段84的外径。尾部92具有更刚性的构造(例如,金属海波管),其适于牢固地与手柄60一起组装。还可设想其它材料和构造。例如,在替代的实施例中,远侧管和近侧管84、86一体形成为单个均质管或实心轴。
尖端82形成或限定鼻锥体,该鼻锥体具有适于促进与人体组织无损伤接触的、朝远侧渐缩的外表面。尖端82可相对于内支承轴80固定或者可滑动。
毂56用于选择性地联接带支架假体心脏瓣膜(未示出)相对于内轴组件54的对应特征,并能构造成组装到内支承轴80上。在图3A-3C中更详细地示出了毂56的一个实施例。毂56可用于将支架框固定至输送装置50,直至期望释放病人内的支架框为止。毂56包括基圆柱部102以及在圆柱部102的一端处的凸缘104。凸缘104的直径至少略大于圆柱部102的直径。圆柱部102包括围绕其外周界的多个凹口106。凹口106可以例如是半球形或半个半球形,或者可具有另一凹入形状。凹口106是成形为与对应的支架框线材的向外突出部配合的凹入区域,以有助于将支架框固定至输送装置。即,突出部可设置在一定数目的支架框线材的端部(或支柱)上,其中这些突出部设计成装配到凹口106内或与其配合并且形状也可以是半球形或半个半球形。从支架框线材伸出的突出部的数目较佳地与毂56的圆柱部102上的凹口106数目相等;然而,设置在特定的支架框上的突出部的数目可以与对应套筒(collar)上的凹口数目不同。
每个凹口106的形状可以与特定毂的其它凹口的形状和尺寸相同或相似。支架框的支架框线材上的、将与凹口配合的每个突出部的形状和尺寸可精确地或紧密地匹配将与其配合的凹口。然而,突出部可至少比其将定位到的对应凹口略小和/或与凹口的形状不同。在任何情况下,每个突出部应能稳固地安置于对应的凹口内以在部件之间有效配合。从成形的突出部延伸的每根支架框线材的厚度可以与支架框线材的其余部分相同,或者厚度可以是不同的。然而,在一实施例中,线材的厚度将小到足以在它们的突出部定位在凹口106内时线材不延伸超过毂56的凸缘104的外周界。此外,可设想支架框的突出部可从支架线材构造的冠状部(crown)或其它区域伸出,具有突出部的附加线材可设置成从现有支架结构延伸,或者其它结构可设有这种突出部。
在图4中示出了可用于本发明的经导管带支架假体心脏瓣膜输送装置的毂56’的另一实施例。毂56’是包括围绕毂周界延伸的径向凹槽108的大致圆柱形元件。尽管该实施例中的凹槽108在毂56’的整个周界延伸,但毂56’可替代地包括彼此间隔开的多个凹槽。
返回图2A,毂56可呈现与上述说明不同的各种其它形式。例如,毂56可包含构造成与带支架假体心脏瓣膜30(图1B)的对应特征(例如,由支架框32形成的线材延伸部或支柱)接界的槽、弹簧等。
释放套管组件58一般构造成使假体心脏瓣膜30(图1B)选择性地捕获至毂56。考虑到此,释放套管组件58包括安装套筒或基部150、一个或多个偏置构件152以及释放套管154。一般来说,安装基部150将释放套管组件58联接至内支承轴80。释放套管154的尺寸设计成可滑动地设置在毂56上,而偏置构件152用于如下所述使释放套管154相对于安装基部150及因此相对于毂56偏置到一纵向位置。
安装基部150可呈现适于不可动地固定安装至内支承轴80的各种构造。例如,安装基部150可以是连结到内支承轴80的环或套筒。还可设想适于建立相对于内支承轴80的固定位置以及在偏置构件152内产生或由偏置构件产生的抵抗力的其它结构。例如,在其它实施例中,可省去安装基部150,且每个偏置构件152的与释放套管154相对的端部直接附连于内支承轴80。
偏置构件152是板簧状本体或臂,并围绕释放套管154的周界彼此间隔开。在一些构造中,释放套管组件58将包括偏置构件152中的两个,如果需要的话,它们也可定位在释放套管154的大致相对两侧处,尽管它们可以相对于彼此不同地定位。在其它构造中,仅设置偏置构件152中的一个。在还有其它实施例中,释放套管组件58包括三个或更多个偏置构件152,且每个偏置构件152可构造成与其它的偏置构件152不同或相同。无论如何并如下更详细地所述,偏置构件152可具有形状记忆的特性,从而正常地或自然地呈现图2A中反映的向外弯曲的形状,并能在外部受迫挠曲成更笔直的形状。当去除外力时,偏置构件152朝正常弯曲的形状自回复。其它的与弹性相关的形状或结构也是可接受的。
释放套管154的尺寸设计成可滑动地接纳于包括凸缘104的毂56上的管状本体。释放套管154设计成由于设置在释放套管154与基圆柱本体102和凸缘104的最大外径之间的间隙而自由地在毂56上运动。在一些构造中并且如图5中清楚所示(以其它方式示出组装到另一实施例的毂56”上的释放套管154,该毂56”包含位于基部102内的纵向槽158),释放套管154形成或限定从其远侧端部162延伸并相对于该远侧端部开口的至少一个纵向凹口160。释放套管154可包括与毂56所设有的纵向槽158的数目相对应的多个凹口160。凹口160可以是相同的并且相对于释放套管154的周缘设置成,当释放套管154组装到凸缘104上时,凹口160中的每个与槽158中对应的一个纵向对准。在释放套管154形成凹口160中的两个(或更多个)的实施例中,两个(或更多个)指部164由相邻的凹口160构成或者在相邻的凹口之间。例如,在第一和第二凹口160a、160b之间形成第一指部164a。当每个凹口160可具有相对均匀的周向宽度时,可选地紧邻远侧端部162形成增大的周向宽度。替代地,凹口160可具有其它形状,并且在还有其它实施例中省去。
返回图2A,包括偏置构件152和/或释放套管154的释放套管组件58可由诸如金属或聚合物(例如,镍钛诺TM、不锈钢、迭尔林TM等)的一种或多种材料制成。材料具有例如在0.002-0.007英寸数量级上的厚度,尽管厚度可以比这个尺寸范围小或者大。释放套管组件58可具有在例如5-15毫米数量级上的长度,以向各部件提供柔性和弹性径向强度。材料可具有闭孔或开孔设计。
释放套管组件58在便于假体心脏瓣膜的局部和完全展开时的操作是基于如由偏置构件152表示的释放套管154的纵向位置。如上所述,偏置构件152形成为正常地呈现在图2A中大致反映的弯曲形状。总地由偏置构件152(处于其正常状态)限定的直径大于输送套管组件内腔76的直径。因此,当释放套管组件58设置在囊62内(或在输送套管轴70内)时,偏置构件152受迫径向向内挠曲,从而实现安装基部150和释放套管154之间纵向间距增大。当去除这种外力时,偏置构件152自回复到图2A中所反映的自然状况,由此使释放套管154偏置到相对于安装基部150的初始纵向间距。图6A和6B以简化的方式示出了这种关系。图6A反映了建立安装基部150与释放套管154之间的第一纵向间距L1的偏置构件152的正常状态。当受到压缩力(例如,在插入输送套管组件52(图2A)内时)时,偏置构件152如图6B中所示向内挠曲。由于安装基部150在空间上固定(即,附连于内支承轴80(图2A)),所以挠曲的偏置构件152推动释放套管154远离安装基部150至大于第一纵向间距L1的第二纵向间距L2。当去除压缩力时,偏置构件152自回复到图6A的构造,由此将释放套管154朝安装基部150拉回。
返回到图2A,手柄60通常包括外壳170和致动机构172(总地标记)。外壳170保持致动机构172,而致动机构172构造成便于输送套管组件52相对于内轴组件54进行滑动。外壳170可具有适于使用者方便操纵的任何形状或尺寸。在一种简化的构造中,致动机构172包括使用者界面或致动件174,它们由外壳170可滑动地保持并联接至套管连接件本体176。输送套管组件52的近侧端部72联接到套管连接件本体176(例如,在一些实施例中经由可选的安装凸台178)。内轴组件54以及尤其是近侧管86可滑动地接纳于套管连接件本体176的通道180内,并刚性地连接至外壳170。因此,致动件174相对于外壳170的滑动引起输送套管组件52相对于内轴组件54运动或滑动,例如以如下所述实现假体从内轴组件54展开。替代地,致动机构172可呈现与通过图2A的说明所包含的那些形式不同的各种其它形式。类似地,手柄60可包含诸如盖帽182和/或流体端口组件184的其它特征。
图7示出了本发明的用于置换(或修复)病人的有缺陷的心脏瓣膜并包括输送装置50内带支架假体心脏瓣膜30的系统200的一部分。在图7中输送装置50的加载状态下,假体心脏瓣膜30褶缩到内轴组件54上,而输送套管组件52定位成使囊62围绕假体心脏瓣膜30并将其压缩性地保持在所示压缩构造,由此形成修复系统200的加载状况。毂56与释放套管组件58(总地标记)安装至内支承轴80,而释放套管154向应于在输送套管轴70内的放置经由偏置构件152(局部示出)的挠曲在圆柱形基部102上可滑动地引导。释放套管154能沿凸缘104可滑动地支承,以更好地确保相对于圆柱形基部102的期望定位。然后,在此构造下,假体心脏瓣膜支架框32的一部分(例如,支柱202)经由释放套管154捕获至毂56。
然后,加载好的输送装置50可用于将假体心脏瓣膜30经皮输送至植入位点,诸如有缺陷的心脏瓣膜。例如,输送装置50操纵成使被压缩的假体心脏瓣膜30以逆行方式朝植入位点前进通过股动脉的切开结构、进入病人的降主动脉、在主动脉弓上、通过升主动脉并大致在中途横过有缺陷的主动脉瓣(用于主动脉瓣修复过程)。然后,假体心脏瓣膜30能从输送装置50局部或完全展开。借助于任一过程,囊62(图2A)从假体心脏瓣膜30上朝近侧缩回或撤回。如在图8A中大致所反映地,在囊62朝近侧缩回的初始阶段,远侧端部74大致位于沿带支架假体心脏瓣膜30的中间长度处。因此,假体心脏瓣膜30的远侧区域210相对于囊62的远侧端部74“露出”并允许自扩张。然而,由于远侧端部74在释放套管组件58(在图8A中被隐藏)的远侧,所以假体瓣膜30的近侧区域保持固定至输送装置50。图8B示出了经皮指向处于局部相关状态的天然瓣膜和输送装置50的系统200;如图所示,假体心脏瓣膜30局部展开或扩张,又保持连接至输送装置50。
通过使输送套管组件52进一步缩回来继续输送过程。如图9A中所示(其中,为了清楚的目的而省去带支架假体心脏瓣膜30),朝近侧缩回使远侧端部74大致定位到毂56和释放套管154上。由于偏置构件152(图6B)保持在输送套管组件52的范围内,因此在挠曲状态下,释放套管154保持在毂56上,由此保持带支架假体心脏瓣膜30固定地连接至输送装置50。图9B示出了使输送套管组件52进一步依次缩回,从而使远侧端部74紧邻释放套管154近侧定位。然而,由于偏置构件152仍作用于输送套管组件52或受其限制,带支架假体心脏瓣膜30保持固定在释放套管154与毂56之间。如图所示,在此局部展开状态下,带支架假体心脏瓣膜30的相当一部分(例如90%)已朝扩张状态自扩张。
在图9B的局部展开的阶段中(或任何其它的顺序上在前的局部展开阶段),临床医生可对局部展开的假体心脏瓣膜30相对于植入位点进行期望的评估。明显的是,假体心脏瓣膜30的绝大部分,包括例如流入区域和至少一部分的流出区域,处于扩张构造。因此,本发明的瓣膜置换系统和输送装置及方法使临床医生能够作出假体心脏瓣膜30相对于植入位点的精确评估。在临床医生确定假体心脏瓣膜30应重新定位的情况下,在一些构造中,囊62可朝远侧前进回到假体心脏瓣膜30上,由此重新套住或重新捕获假体心脏瓣膜30并返回到压缩构造。替代地,输送装置50也可包括用于实现假体心脏瓣膜30的重新捕获的其它特征。
当期望假体心脏瓣膜30从输送装置50完全展开时,囊62朝近侧进一步缩回到偏置构件152上。如图10A和10B中所示(为了便于解释从图10A和10B的视图中省去假体30(图1A)),当偏置构件152依次从囊62的范围释放时,偏置构件152朝它们的自然状态自回复。这种动作又引起偏置构件152使释放套管154从毂56(或至少圆柱形基部102)朝近侧缩回,如由图10A与图10B的构造对比所反映地。
释放套管154相对于毂56的缩回允许支架框32如图11A和11B中所示从毂56完全释放。一旦释放套管154已朝近侧自缩回超出支架框32,假体心脏瓣膜30就从释放装置50完全释放(例如,由于支架框32的自扩张)。图11B反映了被释放的假体心脏瓣膜30现植入至天然瓣膜。然后,可从病人移除输送装置50。
输送装置50构造成假体瓣膜30的支架框32将在输送顺序的预设计步骤从输送装置50释放。此输送装置50由此有利地允许使用者在从输送装置50释放支架之前使外套管整个从带瓣膜支架移出。此外,输送装置50允许带瓣膜支架的出流部分打开或释放,因而可在最终释放带瓣膜支架之前确定瓣膜功能。如果瓣膜功能少于最佳状况和/或如果期望在瓣膜从输送装置50完全释放之前重新定位瓣膜,可以相反次序来执行上述过程步骤,直至瓣膜支架在套管内充分压缩以使瓣膜支架能移动到不同的位置或从病人移出。
本发明的输送装置提供用于例如置换主动脉瓣的支架的放置。替代地,本发明的系统和装置能用于置换其它瓣膜和/或将植入支架的本体其它部分内。当输送带瓣膜的支架以置换主动脉瓣时,本发明的输送装置可例如与逆行输送方法一起使用,尽管可设想可对输送装置作一定修改就可使用顺行输送方法。借助于在此所述的系统,在带瓣膜支架部署到病人内但还未从其释放装置释放期间,可有利地保持通过瓣膜的全部或部分血流。这个特征可有助于防止在用一些其它已知的输送装置的假体瓣膜植入过程中血流停止或受阻时会发生的并发症。此外,临床医生可以由此评估小叶的打开和关闭、诊断任何瓣膜旁渗漏并在最终释放带瓣膜支架之前评估瓣膜在目标解剖体内的冠状流和适当定位。
因为经常期望使用于经皮输送带瓣膜支架的系统直径最小化,所以支架线材和对应的延伸元件的数目设计成或选择成使支架框与输送装置之间的附连质量最佳,同时提供在植入病人内时具有一定期望特征的支架。
在此所示和所述的输送装置可为了输送气囊扩张型支架而在本发明的范围内作改型。即,将气囊扩张型支架输送到植入位置可使用本发明的输送装置的变型来经皮执行。一般来说,这包括提供经导管组件,该经导管组件可如上所述包括释放套管和/或附加的套管和/或包括凹口和/或凹槽的套筒。这些装置还可包括输送导管、气囊导管和/或引导线。用于这种类型装置的输送导管限定引导线可滑动地设置于其内的内腔。此外,气囊导管包括流体连接至膨胀源的气囊。注意到如果植入的支架是自扩张型支架,则将不需要气囊,且套管或其它保持装置将用于使支架保持在其压缩状态直至如在此所述地使支架展开。在任何情况下,对于气囊扩张型支架,经导管组件的尺寸为了期望地经皮接近植入位置而适当地设计。例如,经导管组件的尺寸可设计成经由颈动脉、颈静脉、锁骨下静脉、股动脉或静脉等处的创口输送到心脏瓣膜。基本上,进行任何经皮脉间渗透可便于使用经导管组件。
借助于安装至气囊的支架,经导管组件经由输送导管输送通过病人内的经皮创口(未示出)。植入位置通过将引导线插入病人内来定位,该引导线从输送导管的远侧端部延伸,而气囊导管以其它方式缩回到输送导管内。然后,气囊导管从输送导管沿引导线朝远侧前进,而气囊和支架相对于植入位置定位。在替代的实施例中,支架经由侵入性最小的手术切开(即,非经皮)输送到植入位置。在另一替代的实施例中,支架经由开放式心脏/胸腔手术进行输送。在本发明的支架的一个实施例中,支架包括不透辐射、产生回声或MRI可见材料以便于从视觉上证实支架的适当放置。替代地,其它已知的手术视觉辅助件可包含到支架中。关于将支架放置在心脏内的所述技术可用于监测和校正支架沿纵向相对于该支架定位于其中的解剖结构长度的放置。一旦支架适当定位,气囊导管操作成使气囊膨胀,从而使支架过渡到扩张状况。
已参照本发明的几个实施例对本发明进行了说明。给出前述详细说明和实施例的目的仅是为了清楚地理解本发明。不应从中理解为不必要的限制。对本领域的技术人员显然可对所述实施例进行多种改变而不偏离本发明的范围。因此,本发明的范围不应限于本文所述的结构。
Claims (22)
1.一种用于经皮部署包括支架框的带支架假体心脏瓣膜的输送装置,瓣膜结构附连至所述支架框,所述装置包括:
输送套管组件,所述输送套管组件终止于远侧端部并形成内腔;
内轴,所述内轴可滑动地设置在所述内腔内;
毂,所述毂从所述内轴突出并构造成可释放地接纳假体心脏瓣膜支架框的一部分;以及
释放套管组件,所述释放套管组件设置在所述输送套管组件和所述内轴之间,所述释放套管组件包括可滑动地围绕所述内轴设置的释放套管;
其中,所述输送装置构造成提供加载状态以及展开状态,在所述加载状态下,所述输送套管组件将带支架假体心脏瓣膜保持在所述内轴上并经由所述释放套管联接至所述毂,在所述展开状态下,所述输送套管组件和所述释放套管的远侧端部从所述假体心脏瓣膜撤回,以允许所述假体心脏瓣膜从所述毂释放。
2.如权利要求1所述的输送装置,其特征在于,所述释放套管组件构造成使所述释放套管相对于所述毂朝近侧缩回,而所述输送套管组件的远侧端部从所述释放套管朝近侧缩回。
3.如权利要求1所述的输送装置,其特征在于,所述释放套管形成从所述释放套管的所述远侧端部延伸的至少一个纵向凹口。
4.如权利要求3所述的输送装置,其特征在于,所述至少一个纵向凹口包括多个周向间隔开的纵向凹口。
5.如权利要求1所述的输送装置,其特征在于,所述释放套管组件还包括安装基部,所述安装基部通过至少一个偏置构件连接至所述释放套管。
6.如权利要求5所述的输送装置,其特征在于,所述至少一个偏置构件是板簧状本体。
7.如权利要求5所述的输送装置,其特征在于,所述安装基部固定至所述毂近侧的所述内轴。
8.如权利要求7所述的输送装置,其特征在于,所述释放套管组件能从挠曲状态自过渡到正常状态,而且所述挠曲状态下的所述释放套管与所述安装基部之间的纵向间距大于所述正常状态下的间距。
9.如权利要求8所述的输送装置,其特征在于,所述释放套管组件包括使所述释放套管与所述安装基部互连的两个偏置构件。
10.如权利要求8所述的输送装置,其特征在于,由所述正常状态下的所述偏置构件总体限定的外径大于所述输送套管组件的所述内腔的直径。
11.一种用于置换病人有缺陷的心脏瓣膜的系统,所述系统包括:
假体心脏瓣膜,所述假体心脏瓣膜具有支架框和附连于所述支架框的瓣膜结构,所述支架框限定远侧区域和近侧区域,所述远侧区域形成至少一个支柱;以及
输送装置,所述输送装置包括:
输送套管组件,所述输送套管组件终止于远侧端部并形成内腔,
内轴,所述内轴可滑动地设置在所述内腔内,
毂,所述毂从所述内轴突出并构造成可释放地接纳所述至少一个支柱,
释放套管组件,所述释放套管组件设置在所述输送套管组件和所述内轴之间,所述释放套管组件包括可滑动地围绕所述内轴设置的释放套管;
其中,所述系统构造成提供加载状态,在所述加载状态下,所述假体心脏瓣膜保持在所述输送套管组件与所述内轴之间,所述假体心脏瓣膜包括捕获于所述释放套管与所述毂之间的所述至少一个支柱。
12.如权利要求11所述的系统,其特征在于,所述释放套管组件构造成使所述释放套管相对于所述毂朝近侧缩回,而所述输送套管的远侧端部从所述释放套管朝近侧缩回。
13.如权利要求11所述的系统,其特征在于,所述释放套管组件还包括安装基部,所述安装基部通过至少一个偏置构件连接至所述释放套管。
14.如权利要求13所述的系统,其特征在于,所述至少一个偏置构件是板簧状本体。
15.如权利要求13所述的系统,其特征在于,所述安装基部固定至所述毂近侧的所述内轴。
16.如权利要求15所述的系统,其特征在于,所述释放套管组件能从挠曲状态自过渡到正常状态,而且所述挠曲状态下的所述释放套管与所述安装基部之间的纵向间距大于所述正常状态下的间距。
17.如权利要求16所述的系统,其特征在于,所述释放套管组件包括使所述释放套管与所述基座互连的两个偏置构件。
18.如权利要求17所述的系统,其特征在于,由所述正常状态下的所述偏置构件总体限定的外径大于所述输送套管组件的所述内腔的直径。
19.一种将带支架假体心脏瓣膜经皮部署到病人植入位点的方法,所述方法包括:
接纳加载有可径向扩张的假体心脏瓣膜的输送装置,所述假体心脏瓣膜具有瓣膜结构所附连至的支架框,所述输送装置包括输送套管组件、从所述内轴突出的毂以及包括释放套管的释放套管组件,在所述装置的加载状态下,所述输送套管组件包含以压缩构造位于内轴上的所述假体心脏瓣膜,所述释放套管将所述支架框可滑动地捕获至所述毂;
在加载状态下,处于所述压缩构造的所述假体心脏瓣膜经由输送装置输送通过所述病人的人体内腔并输送至所述植入位点;
使所述输送套管组件从所述假体心脏瓣膜朝近侧缩回;以及
允许所述支柱从所述毂释放,包括所述释放套管组件使所述释放套管相对于所述毂自缩回。
20.如权利要求19所述的方法,其特征在于,使所述输送套管组件朝近侧缩回包括在局部展开状态下将所述输送套管组件的远侧端部纵向定位在所述假体心脏瓣膜的远侧端部与所述释放套管之间,因而所述假体心脏瓣膜的远侧端部露出,并且所述局部展开状态包括所述露出的远侧端部从压缩构造向正常构造自扩张,且所述假体心脏瓣膜的近侧部通过所述至少一个支柱捕获于所述释放套管与所述毂之间而保持固定至所述输送装置。
21.如权利要求19所述的方法,其特征在于,所述释放套管组件还包括使所述释放套管与安装基部连接的至少一个偏置构件。
22.如权利要求21所述的方法,其特征在于,所述安装基部固定至所述释放套管近侧的所述内轴,此外使所述输送套管朝近侧缩回包括将所述输送套管组件的所述远侧端部定位在所述释放套管的近侧,因而所述偏置构件朝正常状态自过渡并使所述释放套管从所述毂缩回。
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EP2470119B1 (en) | 2017-05-10 |
AU2010286587A1 (en) | 2012-03-15 |
US20110098805A1 (en) | 2011-04-28 |
US8414645B2 (en) | 2013-04-09 |
EP2470119A1 (en) | 2012-07-04 |
CN102573703B (zh) | 2014-12-10 |
JP2013503009A (ja) | 2013-01-31 |
WO2011025945A1 (en) | 2011-03-03 |
JP5744028B2 (ja) | 2015-07-01 |
US20130204356A1 (en) | 2013-08-08 |
AU2010286587B2 (en) | 2013-10-17 |
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