CN103108611A - 瓣膜置换装置、用于瓣膜置换装置的递送装置以及瓣膜置换装置的生产方法 - Google Patents
瓣膜置换装置、用于瓣膜置换装置的递送装置以及瓣膜置换装置的生产方法 Download PDFInfo
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Abstract
一种用于心脏瓣膜置换的装置包括瓣膜件,所述瓣膜件具有至少两个瓣膜小叶,其优选由心包膜组织制成。每个瓣膜小叶包括至少两个翼片。所述装置还包括支架件,其配置为径向地可压缩至压缩态,并径向地可展开至功能态。所述支架件包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部。所述中间部具有至少两个连合支杆,其大致平行于跨越第一端至第二端的轴线排列。所述连合支杆形成为叉骨形状。
Description
技术领域
本发明涉及一种用于瓣膜置换、尤其是主动脉瓣膜置换的装置。此外,本发明还涉及一种用于瓣膜置换装置的递送装置以及涉及一种瓣膜置换装置的生产方法。瓣膜置换装置还可以指支架瓣膜或瓣膜支架。
背景技术
为了使外科医生接近病人的心脏,心脏瓣膜置换术的常规方法需要在病人的胸骨(“胸骨切开术”)或胸腔(“胸廓切开术”)切开相对大的开口。此外,这些方法需要停止病人的心脏跳动并需要心肺分流(即使用心肺分流机来使病人的血液氧化和循环)。近年来,已致力于通过经血管方法(通过股动脉递送新的瓣膜)或由经心尖途径(其中置换瓣膜在肋骨之间递送且直接通过心脏壁到达植入位置)通过经较小皮肤切口插入的导管来递送和植入心脏置换瓣膜来建立更少创伤的心脏瓣膜置换术。
支架瓣膜和用于经由导管放置置换瓣膜的递送系统在本领域是公知的,并例如在WO2007/071436和WO2009/053497中公开。
一些已知的支架由诸如镍钛诺的形状记忆材料制成,且是自展开的。所述瓣膜可来自动物,例如猪主动脉瓣。可替代的,所述瓣膜可以至少部分地由诸如涤纶的合成材料制成。
例如,WO2007/071436公开了一种瓣膜置换装置,其包括瓣膜元件和支架元件。所述支架元件包括三个不同部分,其中一个部分容纳瓣膜元件。所述瓣膜元件包括三个小叶,其可由生物学材料或人造材料制成。这三个不同部分可以具有不同直径。
一些已知置换瓣膜支架的主要缺陷是即使处于折叠(褶皱)状态,它们的直径对于支架的经血管输送来说还通常太大。支架的经股动脉输送,其中该支架需要前行越过主动脉弓,需要小于18French(6mm)的更小的直径。在如果需要使用较小皮肤切口和/或心脏壁的较小切口时,该小的直径也可以用于经心尖输送。
将一些已知的支架瓣膜皱缩至小于18French的直径将在置换瓣膜上生成高的应力,这会导致损坏。
因此,有针对置换瓣膜装置的需求,其消除了已知的缺点,以及其特别能够皱缩至小的直径而没有损坏置换瓣膜的风险,以及其可以可靠地放置及紧密地锚固在主动脉环上。
发明内容
本发明的各方面在权利要求书中限定。
宽泛地说,本发明的一个方面是提供一种用于心脏瓣膜置换的装置,其包括具有至少两个瓣膜小叶的瓣膜件(和/或组织瓣膜)。术语“瓣膜件”这里用于指代全体小叶,无论所述小叶是否固定在一起以限定独立于其他组件的单一瓣膜结构。
所述小叶优选地由心包膜组织制成,最优选地由猪心包膜组织或牛心包膜制成。猪心包膜可以合意的薄以及足够的耐用。牛心包膜可以更厚以及在期望时甚至可以更加耐用。每个瓣膜小叶包括至少两个翼片。该装置还包括支架件,其构造以径向地可压缩至压缩态,并可展开至功能态。该支架件包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部分。所述中间部分具有至少两个连合支杆,其可任选地和/或大致平行于跨越第一端至第二端的轴线排列。所述小叶的翼片直接附接至所述连合支杆,优选地附接至设置在所述连合支杆上的附接装置。
所述瓣膜小叶构造和尺寸用于形成置换瓣膜。在一些实施例中,所述小叶具有直的或稍微弯曲的上部自由边、两个侧边以及基本弓形的下边。在每个侧边上布置至少一个翼片,优选地布置在小叶的上部自由边区域中。在所述瓣膜置换装置中,定位所述至少两个小叶以使得它们的上部自由边可以在心脏瓣膜置换的情形中,在心脏舒张期压缩在一起以阻止在一个方向上、例如朝向心脏的血流,以及在心脏收缩期散开以允许在另一个方向上、例如远离心脏的血流。
更优选的,设置了三个瓣膜小叶。这允许模拟例如主动脉瓣、肺动脉瓣、三尖瓣或二尖瓣的自然三尖瓣结构。可替代的,所述瓣膜置换装置还可以包括更多小叶,诸如四个、五个或更多。
虽然已知使用大量选择的不同人工材料用于置换瓣膜,优选的是根据本发明的瓣膜置换装置的至少两个小叶由心包膜组织制成。更优选的,所述至少两个小叶由猪心包膜组织制成。心包膜组织足够薄且还耐用以足以用作小叶材料。猪心脏表现出关于人类心脏的大量相似处。因此,使用猪心包膜组织是有利的。此外,猪心包膜组织可容易获得。对于本发明来说,不指示使用猪主动脉瓣,这是由于它太厚以及不能够使得瓣膜置换装置的皱缩至小于20French。如前面所提及的,牛心包膜组织也可以在期望更大耐用性时用作小叶,其可任选地以较厚组织为代价。
所述支架件优选的是自展开型。该支架在本领域是已知的且通常包括或由形状记忆材料形成,诸如镍钛诺。可替代地,所述支架件还可由或包括塑料的可变形材料制成,并可通过诸如球囊导管的外部装置展开至功能态。
在压缩态,例如皱缩态,所述支架件可以插入病人心脏瓣膜区域中,诸如主动脉瓣。此外,支架件在压缩态的直径使得它能够穿过诸如股动脉的动脉前行至病人心脏中。支架件在压缩态的直径和/或挠性并因此优选的使得所述瓣膜置换装置可以前行穿过主动脉弓。
在功能态,所述支架件处于至少部分展开、或非压缩构造。可任选的,所述支架件限定内部导管空间。所述导管空间通常可以是圆柱形和/或管状。所述瓣膜小叶布置以横跨支架件内的内部空间。一旦瓣膜置换装置定位在靠近病人自体瓣膜的目标位置时,所述支架件展开至其功能态。优选的,所述支架件可以另外的包括锚固元件,其允许在支架元件展开后该装置在心脏血管内的牢固附接。
病人的自体瓣膜小叶可以通过展开支架件来推开。一旦完全展开,布置在支架件内的瓣膜件将代替自体瓣膜的功能。
支架件优选地包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部分。所述瓣膜件因此优选的布置在所述支架件的中间部分中。可任选地,支架件还构造成使得所述中间部分包括锥形和/或圆柱形导管空间,其任选的具有恒定直径,所述直径最优选的处于15mm至35mm的范围。所述中间部分的长度因此优选的处于10mm至50mm的范围。
在功能态,所述第一和第二端限定流入口和流出口,在使用中血液可以流过或环流。根据本发明的瓣膜置换装置的简单实施例仅包括所述中间部分,其包括第一端和第二端。然而,更优选的,根据本发明的瓣膜置换装置包括至少另外的流入部和/或另外的流出部,其布置在所述中间部与所述第一端和/或所述第二端之间。
“流入部”这里理解为血液进入所述导管空间的支架件部分和/或使用中处于瓣膜小叶上游的支架件部分;例如,在半月瓣和/或主动脉瓣中,定向朝向心室的支架件部分。
因此,“流出部”这里理解为血液离开所述导管空间的支架件部分和/或在使用中处于瓣膜小叶下游的支架件部分;例如,位于针对半月瓣的主动脉中的部分。
所述流入部和所述流出部进而可以具有相同长度或具有不同长度。此外,所述流入部和/或所述流出部通常可以限定管状通道的内部通道空间。所述通道空间通常可以是圆柱形的。更优选的,所述流入部和所述流出部通常包括圆锥通道,即具有增加或缩减直径的通道。可替代的,所述流入部和流出部可以包括任何几何形状的内部通道空间。
可任选的,所述流入部和所述流出部可以具有相同的最大直径或不同的最大直径。“最大直径”这里理解为该部分中的最大直径。可任选的,所述流入部具有比所述流出部小的最大直径。此外,所述中间部具有小于所述流入部或所述流出部最大直径的直径。更优选的,所述流入部和所述流出部具有在所述第一端和第二端方向上增加的直径。可替代的,可以在所述流入部和/或所述流出部与所述中间部之间布置其他部分。
在优选实施例中,所述流入部具有20mm至35mm范围内的最大直径,以及所述流出部具有20mm至55mm的最大直径。
支架件还可以包括下锚冠。所述下锚冠可以限定至少部分锥体。所述下锚冠优选的位于所述支架件的第二端和中间部分之间,并优选的构造以置于环内和/或延伸至环的心室侧。
附加地,所述支架件还可以包括上锚冠,其与下锚冠相连通或靠近下锚冠。所述上锚冠可以限定至少部分锥体。所述下锚冠的所述锥体在第二端方向上向外倾斜,而所述上锚冠的锥体在中间部方向上向外倾斜,例如以使得置于环的主动脉侧上。
优选的,所述支架件还包括稳定拱,其与所述连合支杆连接并朝第一端延伸。所述稳定拱优选的构造以接合升主动脉从而将支架件纵向地定位在主动脉或主动脉环中,进而倾向于在植入期间校正支架件关于升主动脉的任何倾斜。所述连合支杆因此通过所述稳定拱彼此连接,由此两个相邻的连合支杆彼此通过一个稳定拱来连接。此外,结合支柱还优选的与上锚冠和/或下锚冠连接。
此外,所述支架件优选的包括至少一个附接元件用于与递送装置(例如,递送装置的支架保持器)匹配接合。所述至少一个附接元件可以构造以限制支架件的轴向位移直至所述支架件完全释放。在一些实施例中,在下冠上设置所述至少一个附接件,从而瓣膜置换装置的心室部和/或流入部是在装置布置期间最后展开的部分。所述支架件可以包括任何适合数量的附接元件,例如,两个、三个或更多。所述附接件可以在环形方向上基本均匀地间隔。
可任选的,所述至少一个附接元件可以包括接合两个支柱的支架U形部。术语U形这里用于包括其通常含有拱顶的任何形状,而不管侧边是直的或是弯曲的、向外凸出的、平行的或非平行的。在支架接收在递送导管的容纳区域时的折叠(例如,压缩)状态,所述支柱可以在附接元件上彼此靠近的放置,以使得U形部的弓形绕超过180度的第一角度延伸以限定例如闭合的或接近闭合的(例如,马蹄形)孔眼,其具有大于支柱间隔的孔径。所述马蹄形的孔眼孔径和所述支柱之间的邻接空间可以一起限定锁眼型形状。在支架从递送导管的容纳区释放的展开(或非折叠)状态,所述支柱可以散开,以及所述U形部的弓形可以绕小于第一角度的第二角度延伸以至少部分地进一步打开所述孔眼。例如,第二角度可以是约180度或更少。在展开状态,所述附接元件可以限定具有拱顶的基本直边U形。
递送导管可以包括设置在支架容纳区的支架保持器。所述支架保持器可以包括:
(i)可接收在每个孔眼内的相应凸起。所述凸起尺寸可使得在支架件处于折叠(皱缩)状态时,所述凸起能够捕获在所述孔眼内并不能在相邻支柱之间通过,和/或
(ii)一个或多个凹槽或间隙,其用于至少在支架件的折叠状态时基本容纳所述附接元件于其中。
上述形式能够在支架瓣膜和递送系统之间提供小型、且可靠的以及自打开和/或自释放的附接件。该附接元件的提供同样不会阻止支架件压缩至期望的小尺寸。
在一些实施例中,中间部包括至少两个连合支杆,其大致平行于横跨第一端至第二端的轴线排列。所述小叶的翼片直接附接至所述连合支杆,优选地附接至设置在所述连合支杆上的附接机构。
所述小叶至所述连合支杆的直接附接提供了小叶的高变形阻力。对比于本领域已知的瓣膜置换支架,可任选地,可以省略小叶和能够经受变形阻力的连合支杆之间的组织的多余层,小叶至连合支杆的直接附接可缩减折叠的支架件的厚度。
根据本发明的另一个方面,提供了一种用于心脏瓣膜置换的装置,其包括瓣膜件和/或具有至少两个瓣膜小叶的组织瓣膜。所述至少两个瓣膜小叶优选的由心包膜组织制成,最优选的由猪心包膜组织制成。所述两个瓣膜小叶中的每个包括至少两个翼片。该装置还包括支架件,其构造以径向地可压缩至压缩态,并可展开至功能态。该支架件包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部分。所述中间部分具有至少两个连合支杆,其可任选地和/或通常地平行于跨越第一端至第二端的轴线排列。所述连合支杆形成为叉骨形状,以及所述翼片直接附接至所述连合支杆,优选的附接至设置在所述连合支杆上的附接机构。
叉骨通常形状像倒立字母“Y”。连合支杆因此包括两个倾斜腿(有时还称作臂)和一个柄。所述倾斜腿可以是直的,但优选的是两个倾斜腿是弯曲的(例如,绕支架件的轴线和/或在圆周表面内)。所述形状无论是直的或弯曲的,优选的选择以使得叉骨的腿与瓣膜小叶的侧边基本互相对准和/或一致。这允许连合支杆对瓣膜小叶的侧边提供良好支撑。瓣膜小叶的侧边可以附接至腿,和/或附接至小叶和连合支杆之间的内裙部材料。所述腿进而成形以使得基本匹配小叶侧边的轮廓。这允许小叶侧边例如通过缝合而直接或间接附接至叉骨状连合支杆的腿,以用于小叶的紧密支撑。
该实施例支架瓣膜置换装置的其他元件的构造类似于针对上面第一实施例所描述的。
连合支杆优选的包括用于瓣膜小叶翼片的附接机构,所述附接机构包括至少一个开口,其适于至少一个翼片的插入。
所述开口优选的构造为通孔,即该开口在所有侧由连合支杆界定和/或侧边包绕。可替代的,所述开口还可以配置为通道狭缝,即仅在三侧由连合支杆界定和/或侧边包围,而一侧开口。所述开口可以是任意合适形状,例如矩形、圆形、椭圆形等。最优选的,开口是以长孔洞形式。开口还适于使得所述瓣膜小叶的至少一个翼片从中插入。因此,连合支杆上的开口位置以及它们的大小选择以使得可以插入瓣膜小叶的至少一个翼片。优选的,所述开口适于使得可以插入例如来自两个相邻瓣膜小叶的两个翼片。可替代的,连合支杆可以包括多于一个这样的开口。这样,具有多个翼片(诸如每个侧边具有两个翼片)的瓣膜小叶可以附接至所述连合支杆。在其他可替代实施例中,连合支杆可以包括彼此平行布置的两个开口,从而相邻瓣膜小叶的翼片每个可以插入单独开口中。所述翼片优选的插入开口中,朝瓣膜小叶折回到连合支杆上并缝合至连合支杆。
所述附接机构可以另外的包括至少两个孔,适于缝合线的插入,所述孔优选的以圆孔形式。提供所述另外的孔促进所述翼片和/或小叶的侧边附接至所述连合支杆。
这些另外的至少两个孔还优选的设置以侧翼包围所述至少一个开口。
支架件优选的包括布置在所述中间部和所述第二端之间的基本平行和/或非平行的管状部,所述管状部具有至少一行网格单元的网格结构,每个叉骨形连合支杆跨至少三个相邻网格单元的序列,使得叉骨从该序列的外侧网格单元延伸而不连接该序列的至少一个中间网格单元。该布置提供了压缩的方便,同时允许叉骨的腿具有足够的分叉以匹配小叶侧边的形状。
在一些实施例中,叉骨腿接合至网格结构序列的外侧网格单元,进而允许连合支杆跨至少三个相邻网格单元而不连接至至少一个中间网格单元。可替代的,每个连合支杆可以配置以跨超过三个相邻网格单元,诸如四个、五个等。另外可替代的,每个连合支杆可以构造以跨不同数量的相邻网格单元。优选的,叉骨型连合支杆的柄通过稳定拱彼此连接。两个相邻叉骨形连合支杆的柄因此可以通过一个稳定拱彼此连通。
瓣膜置换装置可另外的包括内裙部,其优选由心包膜组织制成,并连接至小叶。所述内裙部用于引导支架件的导管空间内的血流,并阻断血液通过支架件间隙的泄露(例如,通过网格结构的网格单元)。
在一些实施例中,内裙部可以具有由扇形凹口状间隙(例如,扇形凹口状切口)间隔开的连合部。每个间隙由各个瓣膜小叶跨越。小叶的侧边和/或下边例如通过缝合而附接至内裙部。
在一些实施例中,内裙部可以朝向所述第二端延伸,所述裙部优选地适于缝合至所述支架装置。所述裙部优选地包覆支架件的至少部分内表面。这减少了可能会由支架件的材料触发的血液湍流的发生。所述套筒还优选地缝合至所述至少两个瓣膜小叶。
另外的,所述支架件的至少一个部分在外侧由外裙部至少部分薄膜。
支架件优选配置以使得处于压缩状态的瓣膜置换装置插入诸如导管的递送装置的护套内时,所述递送装置的和护套的合计直径小于20French,优选小于18French。这允许瓣膜置换装置沿动脉、优选沿股动脉或锁骨下动脉插入。还可以使得瓣膜置换装置使用小的皮肤切口和/或穿过心脏壁的切口经心尖插入。
根据本发明的另一个方面,提供了一种用于心脏瓣膜置换的装置,其包括瓣膜件和/或组织瓣膜,包括至少两个瓣膜小叶,每个瓣膜小叶具有至少两个翼片。所述至少两个小叶可以在所述裙部的内侧连接至一环形裙部。术语“环形”这里用于指代环形的连续结构,且并不限定于精确的圆形或环状结构。一部分裙部材料至少部分地包绕连合支杆而不穿过翼片开口。
根据本发明的又一个方面,提供了一种用于心脏瓣膜置换的装置,其包括支架件,所述支架件具有至少一个部分,其限定至少部分锥体。所述装置还具有多个瓣膜小叶。内裙部布置在支架件内,其重叠在所述至少部分锥体上以限定穿过其中的通道。外裙部布置在支架件外侧,且仅重叠部分所述至少部分锥体。
内裙部和/或外裙部优选的由心包膜组织制成,最优选的由猪心包膜组织制成。
本发明的另一个方面提供了一种瓣膜置换装置,其包括支架件,所述支架件径向可压缩至用于递送的压缩态和径向可展开至功能态。支架件可以包括至少一个(优选为多个)附接元件用于结合递送装置的支架保持器。每个附接元件(或至少一个附接元件)可以包括接合两个支架支柱的U形部。术语U形这里用于包括通常具有拱顶的任意形状,而不管侧边是直的或弯曲的、向外凸出的、平行的或非平行的。在支架接收在递送导管的容纳区域时的压缩状态,所述支柱可以在附接元件上彼此靠近的放置,以使得U形部的弓形绕超过180度的第一角度延伸以限定例如闭合的或接近闭合的(例如,马蹄形)孔眼,其具有大于支柱间隔的孔径。所述马蹄形的孔眼孔径和所述支柱之间的邻接空间可以一起限定锁眼型形状。在支架从递送导管的容纳区释放的展开(或非折叠)状态,所述支柱可以散开,以及所述U形部的弓形可以绕小于第一角度的第二角度延伸以至少部分地进一步打开所述孔眼。例如,第二角度可以是约180度或更少。在展开状态,所述附接元件可以限定基本的非马蹄U形,例如具有拱顶的基本直边U形。
一种用于如前述瓣膜置换装置一起使用的递送装置,可以包括设置在支架容纳区的支架保持器。所述支架保持器可以包括:
(i)可接收在每个孔眼内的相应凸起。所述凸起尺寸可使得在支架件处于折叠状态时,所述凸起能够捕获在所述孔眼内并不能在相邻支柱之间通过,和/或
(ii)一个或多个凹槽或间隙,其用于至少在支架件的折叠状态时基本容纳所述附接元件于其中。
上述形式能够在瓣膜置换装置和递送装置之间提供小型、且可靠的以及自打开和/或自释放的附接件。
本发明的另一个方面提供了一种瓣膜置换装置,其包括支架件,所述支架件支撑至少两个小叶。所述小叶可以是心包膜组织,更优选为猪心包膜组织或牛心包膜。如前面所提及的,猪心包膜可以提供期望的组织厚度。牛心包膜可以稍微更厚但更耐用。
每个瓣膜小叶可以包括至少两个翼片。所述翼片可以用于相对支架件支撑所述小叶。
在一些实施例中,翼片可以直接的连接至支架件的连合支撑件(例如,支杆)。翼片可以连接至设置在连合支撑件上的附接装置。例如,翼片可以穿过连合支撑件中从支架件内部至外部的开口(例如,狭槽或狭缝)。在支架件外部的翼片部分可以折叠抵靠联合支撑和/或缝合至所述连合支撑件。可任选地,在连合支撑件处汇合的两个相邻小叶的相应翼片穿过同一开口。每个翼片可以折叠以抵靠连合支撑件的外部而不与其他翼片重叠。所述两个翼片可彼此不直接连接。
另外的或可替代的,所述小叶可以连接至内裙部。所述小叶可以连接至内裙部的内侧部,翼片穿过内裙部的开口(例如,狭槽或狭缝)至内裙部的外部。内裙部可以具有扇形凹口状间隙,每个所述间隙由相应小叶横跨。所述内裙部可以具有连合部或竖柱,其中设置有开口(例如,狭槽或狭缝)。
另外的或可替代地,限定内裙部的材料可以包括完整的延伸部(例如,舌片),其缠绕在至少部分连合支撑件上,用于包覆连合支撑件部分和/或用于包覆固定至连合支撑件的小叶翼片。所述延伸部可以缝合至连合支撑件。
在一些实施例中,可以使用任意两个或所有三个上述布置的组合。例如,一对相邻小叶的翼片可以穿过内裙部的开口,并穿过连合支撑件的开口。这两个开口基本是互相对准的。所述翼片可以在相反方向上折回,并缝合至连合支撑件的外部(可任选的而不将翼片彼此直接缝合)。在连合支撑件处的内裙部的一个或多个舌片或延伸件可以缠绕在连合支撑件的外部以包覆所述翼片和/或所述连合支撑件。所述延伸件可以缝合至所述连合支撑件。可任选的,所述缝合线可以穿过用于连接翼片的连合支撑件上的相同缝合孔。所述延伸件可以轴向延伸超出翼片,以使得翼片的边被覆盖和保护。
本发明的另一个方面提供了瓣膜置换装置,其包括支架件,所述支架件径向可压缩至用于递送的压缩态和径向可展开至功能态;多个瓣膜小叶,其安装在支架件中;内裙部,其连接至所述瓣膜小叶,所述内裙部在支架件内至少部分地延伸;以及外裙部,其在支架件外至少部分地延伸。
在一些实施例中,外裙部朝向支架件的流入端延伸比内裙部更远。另外的或可替代的,内裙部和外裙部可以部分重叠的,至少对于两裙部的至少一个的表面来说是这样的。另外的或可替代的,内裙部和外裙部不具有任何相连端。另外的或可替代的,内裙部朝向支架件的流出端延伸比外裙部更远。
至少一个裙部上延伸的支架件的至少一部分可任选的包括网格结构,其具有至少一行的多个网格单元。
内裙部的功能是限定支架内的通道以引导血液流向瓣膜小叶,并阻断血液穿过支架件间隙(例如,网格间隙)的泄露。外裙部的功能是提供支架件外侧的密封表面,用于密封周围组织,以阻断与周围组织接触面上的泄露。然而,两个裙部的存在会极大地添加支架所负载材料的厚度,并进而增加将支架瓣膜压缩为期望的小尺寸的难度。通过提供两个裙部使得在轴向方向上仅部分重叠,能够获得两个裙部的益处,而在仅一个裙部延伸的区域中具有缩减的厚度轮廓。重叠搭接裙部比在支架件的内侧和外侧分别边靠边的布置裙部能够提供裙部间更好的密封(例如,尤其需要铭记的是支架瓣膜将会通过压缩而有相当大的变形,以用于递送以及在植入处再展开)。
在轴向方向上的裙部重叠程度例如可以是至少1mm、或至少2mm、或至少3mm、或至少4mm、或至少5mm、或至少6mm、或至少7mm、或至少8mm。另外的或可替代的,在轴向方向上裙部重叠程度例如可以小于10mm、或小于9mm、或小于8mm、或小于7mm、或小于6mm、或小于5mm、或小于4mm。例如,在轴向方向上裙部重叠的程度可以是约4-6mm。
至少一个裙部(可任选的每个裙部)可以离开重叠区域延伸至少1mm的非重叠的轴向距离。针对该裙部或每个裙部的非重叠距离例如可以是至少2mm、或至少3mm、或至少4mm、或至少5mm、或至少6mm、或至少7mm、或至少8mm、或至少9mm、或至少10mm。
在一些实施例中,支架件的流入边或流入口具有由至少一行网格单元的网格结构限定的Z字形。Z字形可以限定为自由顶(例如,在流入端处或限定出一流入端)和众连接顶(例如,连接至远离流入端并朝向流出端延伸的网格结构)的交替序列。在一些实施例中,所述内裙部可以仅延伸至所述的连接顶。外裙部可以与内裙部交叠并比内裙部延伸更远至对应至少一些自由顶的水平。
在一些实施例中,内裙部可以朝向支架件的流入端延伸。外裙部可仅与部分内裙部交叠而与内裙部的最上边保持间隔。外裙部可以朝向(或任选的向)支架件的流入端延伸。外裙部可任选的不与小叶的任何部分交叠(例如,直接或间接穿过支架件)。
内裙部和/或外裙部可以是任何合适材料,诸如心包膜组织(例如,猪心包膜以实现薄)、PET、涤纶等。内裙部和外裙部可任选的由彼此相同的材料制成。
本发明的另一目的是提供一种用于递送用于心脏瓣膜置换装置的递送系统。所述递送系统包括柔性管状导管,其包括近端(或近部)和远端(或远部)以及连接机构(例如,支架保持器)。所述递送装置还包括用于上面所述的心脏瓣膜置换的装置。所述递送装置连接所述连接机构,使得适于定位于或定位朝向心室的所述装置部分朝向所述导管的远端定向,以及适于定位于主动脉的所述装置部分朝向所述近端定向。关于递送装置,术语“远侧”指代远离递送装置的操作者定向以及术语“近侧”指代朝向递送装置的操作者定向。
管状导管的近侧端优选地包括用于操作者的手柄部件。管状导管的远端包括连接机构(例如,支架保持器)用于可释放地连接根据本发明的瓣膜置换装置。所述连接机构可以具有任何合适的类型。优选地,所述连接部件配置为销或其他凸起,其匹配于瓣膜置换装置上相应的附接元件(例如,钩和/或孔眼)。在置换装置的支架件展开后,附着元件从销释放,进而使该装置从所述管状导管解耦合。
瓣膜置换装置在管状导管上的定向允许该装置沿患者动脉插入,优选沿股动脉或锁骨下动脉插入。动脉插入对于一些病人来说是有益的,这是因为该程序比外科手术程序更少的创伤。在需要时,管状导管还可以配置为经心尖插入。
根据本发明的又一个实施例,提供了一种心脏瓣膜置换的方法。将上面所公开的递送装置以压缩状态插入将置换的心脏瓣膜的部位。所发送的装置然后展开。递送装置可任选的通过柔性管状导管沿动脉插入,优选的沿股动脉或锁骨下动脉插入。可替代的,递送装置可经心尖插入心脏的心室中。
本发明的另一个目的是提供一种制造瓣膜置换装置的方法,所述瓣膜置换装置在径向压缩时具有缩减尺寸,其能够快速方便的执行。该目的通过所附权利要求书中限定的制造方法来实现。
在一些实施例中,在根据本发明的制造瓣膜置换装置的方法的第一步中,提供管状裙部,其优选由心包膜组织制成。术语“管状”应该理解为包括通常形状类似圆柱或圆锥截头体的裙部。它还包括具有椭圆截面的裙部,其沿轴具有变化半径等。管状裙部优选的由猪心包膜组织制成。
在接下来步骤中,至少两个小叶,其优选由心包膜组织制成,绕管状套管彼此靠近的布置。小叶的尺寸因此选择以使得一旦所述小叶彼此靠近的布置,则它们跨绕管状套筒的整个圆周。所述小叶的侧边进而至少在它们的上部自由边区域接触。
小叶可从心包膜组织中裁剪出。所述小叶包括自由边,其可选为曲状的,其曲率可以是凸曲率。小叶的尺寸以及自由边的曲率进而以如下方式选择,即允许自由边在支架件处于功能态时彼此密封地接触(即,合紧)。小叶还包括两个侧边,其朝向小叶的下边逐渐变细。下边比自由边短。优选的,所述下边也是弯曲的,更优选的具有凸曲率。术语“凸”理解为限定小叶边相对于小叶表面的曲率。因此,凸弯曲边从小叶凸出。
在切割前,心包膜组织优选的处理以避免小叶在后面阶段中的任何收缩。
小叶的侧边和底边然后附接在管状裙部的表面上,优选的通过缝合。可替代的,小叶还可以通过其他手段附接,诸如胶合等。自由边需要保持未连接至裙部,这是因为它们将形成所组装的瓣膜置换装置中的置换瓣膜。
在接下来步骤中,管状裙部被外翻,从而小叶现在通常位于管状裙部的管状通道的内侧。所外翻的裙部然后最终连接至支架件。
由于根据本发明方法制造的瓣膜置换装置的瓣膜件被从里面翻到外面,小叶至裙部的附接则更加容易且需要更少的步骤。
为进一步减小皱缩的瓣膜置换装置的尺寸,移除与小叶交叠的至少一些套筒组织。这可以通过沿小叶连接裙部的缝合切割裙部来完成。组织的移除优选通过使用剪刀或解剖刀来进行。这允许进一步减少瓣膜置换装置的直径,即除了缝合区域外,仅存在一层组织。该裙部组织的移除产生裙部组织中的扇形凹口状间隙。其由小叶所横跨。套筒组织可以包括相邻小叶汇合的连合部。连合部可以包括环形和/或轴向延伸件(例如,舌片)用于提供保护性缠绕材料,其用于缠绕支架件连合支杆的外部。
所述至少两个小叶优选的另外包括至少两个翼片,优选地在每个小叶的每个侧边布置一个翼片,最优选地处于所述自由边的区域中。可替代的,所述至少两个小叶可以包括多个翼片,例如每个小叶每个侧边上具有两个翼片。在管状裙部外翻后,在裙部中切出至少两个狭缝,并且至少一个翼片插入穿过每个狭缝。可替代的,相邻小叶的两个翼片插入穿过相同的狭缝中。这允许翼片从裙部内侧传至外侧。
翼片然后优选的直接连接至支架件,优选的连接至设置在叉骨形连合支杆上的附接机构,最优选的通过牵拉所述翼片穿过设置在所述连合支杆上的开口,然后将所述翼片缝合至所述连合支杆。然后可以移除所述翼片的多余材料。
所述裙部材料连合部的延伸件可以缠绕连合支杆而不穿过与翼片相同的开口。
优选地,所述管状裙部通常通过将具有合适尺寸的矩形心包膜片绕具有对应瓣膜置换装置的瓣膜件尺寸和形式的尺寸和形式的心轴制成。然后将心包膜片缝合在一起以使得形成通常的管状裙部。然后优选地处理心包膜以产生该组织的收缩,由此管状裙部将采用心轴外轮廓的形式。所述心轴因此可以另外的传递特殊形状至环形裙部。在特别优选实施例中,所述心轴将在所述裙部上施加环形凸起。在将所述至少两个小叶附接至所述环形裙部时,环形裙部将保持在所述心轴上。
此外,所述裙部材料的所述舌片可以缠绕在所述翼片和所述开口上,从而包覆将翼片保持于所述连合支杆上的缝合线。这还在将瓣膜置换装置皱缩至小于18French直径时防止该装置受到任何破坏。
虽然本发明的某些方面已经在上文和/或所附权利要求书中限定,但还要保护针对这里所描述的和/或附图所示意的任何新颖性特征或思想,而不管是否进行了强调。
附图说明
本发明的其他优点和特征将在下面对示例的描述和附图中说明。
图1是根据本发明的瓣膜置换装置的示例性实施例;
图2是根据本发明的瓣膜件的小叶;
图3是具有叉骨形连合支杆的细节视图;
图4a-d是针对小叶翼片的附接装置的不同构型的示图;
图5a-e表示根据本发明制造瓣膜置换装置的方法;
图6表示类似于图3的视图的支架件的可替代实施例;
图7表示用于瓣膜置换装置的递送装置的示意图;
图8示出了表示在支架件处于其压缩状态时支架保持器和附接元件之间关系的特写示意图;以及
图9图解示意了支架件展开至其功能态时的附接元件。
具体实施方式
图1示出了根据本发明的瓣膜置换装置15的优选实施例。瓣膜置换装置15适于通过经股动脉途径插入,但该装置还可以通常通过其他经血管途径或通过经心尖途径插入。置换装置15具有第一端26、第二端27和中间部分17,以及包括支架件20和瓣膜件5。在该实施例中,所述第一端26旨在定位于动脉中,而第二端27旨在定位于或朝向病人心脏的心室。在瓣膜置换装置15就位时,血液将从第二端27经由中间部17流至第一端26。因此,第二端27和中间部17之间的部分还可以称作“流入部”。从而,中间部17和第二端26之间的部分称作“流出部”。
支架件20包括稳定拱21、连合支杆22、上锚冠23、下锚冠24以及附接元件25。支架件的该构造因此类似于共同未决申请EP2205183中所描述的构造。稳定拱21用于在展开期间将支架15稳定在血管中,优选为动脉中。拱21还将它们的近端直接附接至连合支杆22的上部,即远端。从近端开始,拱21的在它们部分长度上径向向外发散以及朝向它们的远端径向向内会聚。术语“远”和“近”在下文中分别用于指示瓣膜置换装置15较远离心脏或较接近心脏的部件或其组件。远端有时还指代主动脉端,以及近端指代心室端。
置换心脏瓣膜的三个小叶31附接至连合支杆22。小叶31由猪心包膜组织形成。上锚冠23用于将支架15连接至心脏瓣膜的主动脉侧,而下锚冠24用于将支架15连接于自体环中、或朝向心脏瓣膜的心室侧。附接机构25使得支架15能够可移离地附接至递送装置。
连合支杆22具有轴向长度L2,其基本等于稳定拱21的轴向长度L1。通常长度L1约是长度L2的约90%至110%。连合支杆22具有叉骨形状并且每个包括上部22a和下部22b,所述上部22a用于瓣膜小叶31的翼片30的直接固定,所述下部22b包括两个腿或臂32、33。所述翼片30通过卷绕和缝合固定至上部22a。小叶31的侧边直接地或间接地缝合至下部22b的两个臂32、33。下冠24通常由管状部形成,其具有网格单元34、35、36的网格结构。每个叉骨形连合支杆22的两个臂32、33跨及至少三个邻接网格单元34、35、36的相应序列。叉骨从该序列的外侧网格单元34、36延伸而无需附接至该序列的至少一个中间网格单元35。
支架的下部,即近端由外裙部34覆盖,其沿网格单元34、35、36的基本一半高度轴向延伸。在支架15的内侧具有内裙部35,其优选由心包膜材料制成,密封叉骨形连合支杆22的两个相邻臂32、33之间的空间。
图2是根据本发明的小叶10的表示。自由边10构造以使得密封地啮合至少一个其他小叶31的自由边10以形成紧密封闭瓣膜。优选的,自由边10是弓形的,然后也可以使用直边。小叶31还包括两个侧边11和下边12。下边12是弓形的,而侧边11是直线的。由侧边11和下边12构成的表面通常称作小叶31的“腹部”。两个翼片30在自由边10区域内布置在两个侧边11上。翼片30大小和形状为使得能够插入设置于瓣膜置换装置的支架件连合支杆上的附接机构中(同样参照图3和4)。至少两个小叶31定位在该装置中以形成瓣膜件,但优选的是该瓣膜件包括三个小叶31。
图3示出了详细视图,其示出了具有叉骨形连合支杆22的支架件20的构造。支架件20显示为处于折叠状态,即皱缩状态。连合支杆22的上部22a通过稳定拱21接合在一起。此外,这些上部22a包括用于小叶31翼片30的固定部件,这里由开口19和孔洞18代表。连合支杆22因而具有整体的叉骨形构造。从该附图能够容易看出,连合支杆22的两个臂32、33跨及下冠24的三个连续网格单元34、35、36的序列。臂32、33进而连接至该序列的外侧网格单元34、36而不连接至该序列的中间网格单元35。下冠24还包括以钩形式的附接元件25。这些附接元件25允许瓣膜置换装置15至递送装置的可移除附接。
图4示出了连合支杆22的上部22a附接机构的构造。图4a所示的构造对应于图3所示的连合支杆22的构造。开口19以长孔形布置在上部22a的中间。开口19形状和大小使得允许至少一个翼片30的插入。然而,开口19的大小优选使得可以插入两个翼片30。此外,开口19在两侧均由四个孔洞18侧翼包围。一个另外孔洞18布置在开口19的顶部。所述孔洞旨在容纳用于将翼片30连接至连合支杆22的缝合线。开口19的可替代构造示于图4b。在该实施例中,开口19构造为上部22a中间的纵向狭缝。再次,开口19由孔洞18侧翼包围。图4C示出了不具有任何孔洞18的其他实施例。开口19示出为纵向狭缝,但可替代的也可以构造为长的孔洞。在该实施例中,翼片30通过开口19插入,朝小叶31折叠并缝合至小叶。图4d示出了其他的可替代实施例。在该实施例中,附接机构仅包括孔洞18。翼片30因而向后折叠在小叶31上并缝合至小叶31。进一步的缝合从翼片30的折叠缝合至开口18,进而将翼片30附接至连合支杆22。
图5表示了制造根据本发明的瓣膜置换装置15的方法。图5a示出该方法的第一步。具有合适尺寸的通常矩形片状心包膜组织2卷绕在具有合适形状的心轴1上。该心轴优选包括特别的形状元件,这里例证性示为凸起部4,以加作用至瓣膜置换装置的内裙部。心包膜组织然后采用缝合线3缝合在一起并可选地推压以促使组织的一些收缩。在接下来步骤中,示于图5b,至少两个但优选为三个翼片31绕所述心包膜组织2的外表面布置。所述翼片31进而布置以使得相邻小叶31的翼片30处于沿心轴1纵轴的相同高度。此外,相邻小叶31在它们侧边在翼片30区域中彼此接触。小叶31然后沿下边12和侧边11缝合至心包膜组织2。翼片30保持自由。此后,心包膜组织4从心轴1移除并外翻(参加图5c)。小叶31现在位于圆柱形心包膜组织4的内侧。移除心包膜组织的多余材料6,例如,通过切割。位于小叶31的外部上的至少部分心包膜组织4沿连接心包膜组织4和小叶31的缝合线7也被移除。在翼片区域中,在心包膜组织4上设置狭缝8,其布置且大小使得能够使得翼片30通过其中。在狭槽8的区域中,留下心包膜组织4的两个舌片9。翼片30然后穿过狭槽8。现在形成的瓣膜件5包括内裙部28和小叶31。除了缝合处7周围区域,瓣膜件5由单层心包膜组织组成。在图5d所示的下一步骤中,瓣膜件5插入支架件20中。翼片30插入定位在连合支杆22上的开口19中,朝小叶31折回并另外通过缝合连接至连合支杆22。缝合线穿过孔洞18。翼片30的过剩材料随后移除。然后,舌片9折叠在连合支杆22的上部22a上以覆盖翼片30的缝合部,因此形成绕连合支杆22上部22a的套筒型。图5e示出了最终的瓣膜置换装置15。瓣膜件5在每个叉骨形连合支杆22的壁32、33的区域中通过缝合部13另外地附接至支架件20。此外,内裙部28通过缝合部14连接至下冠24的网格单元。下冠24可另外的在外侧由外裙部29包覆,如图1的实施例所示。
在一些实施例中,舌片9可以在流入和/或流出方向上具有比翼片30更大的轴向范围。在舌片9绕连合支杆折叠时,舌片9可以轴向延伸超出翼片30的边,进而包覆并保护翼片30。从图5e能够看出,舌片9可以在小叶的水平以上轴向延伸。
图6示意性地说明了支架件的改型结构,以及内裙部35和外裙部34的改型结构。支架件的流入端或流入口具有Z字(曲折)形,其由网格结构的网格单元限定,包括至少一行网格单元。所述Z字形由交替的自由顶50和连接顶52组成。自由顶50限定流入前端。连接顶52与该行中的相邻网格单元连通。
内裙部35的位置由线条54、56所指示,并从连合支杆和/或小叶伸向流入前端。线条53通常指示小叶下边的水平,然而应该意识到的是,内裙部35可以具有轴向延伸至支架件连合支杆的连合部。外裙部34的位置由线条58和60指示,并比内裙部朝向流入前端地延伸更远。
在示意性实例中,如由线条56所指示,内裙部35延伸至对应(至少一些)连接顶52的水平。外裙部34延伸至对应(至少一些)自由顶50的水平。
外裙部34可以具有Z字形边,其基本匹配流入边的Z字形。
内裙部35在相反方向上朝支架的流出端(和/或末端)延伸比外裙部34更远。内裙部和外裙部可以在轴向方向上彼此部分地重叠。轴向重叠的程度例如可以是至少1mm、或至少2mm、或至少3mm、或至少4mm、或至少5mm、或至少6mm、或至少7mm、或至少8mm。另外的或可替代的,在轴向方向上套筒重叠程度例如可以小于10mm、或小于9mm、或小于8mm、或小于7mm、或小于6mm、或小于5mm、或小于4mm。例如,在轴向方向上裙部重叠的程度可以是约4-6mm。
从图6能够看出,至少一些网格单元具有裸露的自由顶50a,其延伸超过该行中相邻网格单元的自由顶50,并不被外裙部34所包覆。裸露的自由顶50a提供附接元件25用于接合递送装置的支架保持器。
从图6的圆圈A以及图3的相应区域中还能够看出,缝合孔可以沿连合支杆的每侧开口设置,以及仅在连合支杆的柄的一个轴向端设置。该布置能够使得连合支杆的柄的尺寸与设置在两个轴向相对端的缝合孔的布置相比减小。
图7图解示意了递送装置62,例如递送导管,用于在心脏处插入瓣膜置换装置。所述导管可以在导丝(由虚线示出)上前行。导管包括远侧部64用于插入人体中并具有用于容纳处于压缩状态的瓣膜置换装置的容纳区域。支架保持器(下文描述)设置在容纳区域中用于限制瓣膜置换装置轴向运动直至支架件展开至其功能态,于是支架件从支架保持器分离。远侧部64还可以包括护套装置用于限制支架件于压缩态以用于输送,护套装置能够操作以拔出支架件以允许支架件展开至其功能态。输送导管62还包括管茎部66,其是任意柔性的,延伸向具有控制手柄的近侧部68。
可以预想到附接元件25的不同实例。通常,每个附接元件25可以由接合从支架件的末端延伸的第一支柱和第二支柱的顶限定。所述支柱可以是限定支架瓣膜10的网格或骨干支架结构的部件。在网格的情形中,与所述支柱关联的网格单元可以轴向凸出超出网格的相邻单元。
在图3中,所述支柱通常可以在压缩态时直线地延伸以在通常限定直边U形的顶处汇合(示于图3),并在支架件展开至其功能态时展开为V形。在图6中,顶是稍微不同的,其在压缩态时通常具有圆形或马蹄U形(示于图6),并在支架件展开至其功能态时通常展开至非马蹄形,例如展开为直边U形(图9)。
参照图8,支架保持器78通常可以包括多个凸起84和/或空隙86用于容纳图3和/或图6的附接元件25。每个空隙86的边90可任选为倒圆或斜切的。众凸起84可以配置成用于在支架件处于其折叠态时分别位于每个附接元件25的顶的内部中。凸起84和附接元件之间的接合限制了附接元件(并因此支架瓣膜10)至少在离开支架保持器24的轴向方向上、以及也可在两个轴向方向上的轴向运动。
在自展开支架件的情形中,所述附接元件25可以在附接元件25延伸出来的支架件部分被递送导管的护套装置打开时脱离。在支架件展开时,支柱散开以打开U形或V形的附接元件顶。随着顶打开,这扩大了附接元件25的内部以利于凸起84和附接元件25之间的脱离。间隙86的斜切边90还随着支柱圆周向展开并靠在边90上作为斜面以径向“抬升”支柱离开间隙88。当附接元件25偶然地粘在间隙86中时,附接元件25的松开可以通过导管的轻微旋转和/或移动轴向位置、从而促进进一步抵靠在边90而完成。
在图6、8和9的特别实例中,凸起84是指状物或销,适于位于在马蹄形附接元件的内部。凸起通常可以是径向凸出的,或可以是以离开支架件的某角度倾斜的,例如达到约10度(例如约5度)的角度。在支架件的折叠状态中(图6和8),支柱彼此紧密停靠在附接元件25处,从而U形部25的拱环形延伸大约180度的第一角度以限定闭合的或接近闭合的孔眼,其具有大于支柱间隔的孔径,用于容纳凸起84。所述孔孔眼径和各支柱间的间隔可以一起限定锁眼型形状。可替代地,支柱可以彼此靠在附接元件25处来闭合孔眼。任一种布置都能够仅通过附接元件25和凸起84之间的接合来限定附接元件25在两个轴向方向上的运动。这通过使用更大的斜面用于间隙86的边90处和/或支架保持器的端面92处是有利的。斜切端面92可以合宜地促进一旦植入时支架保持器78通过瓣膜置换装置的撤回。该布置还允许附接元件的支柱紧密压缩在一起,从而提供的附接元件不会阻碍支架件压缩至期望的小尺寸。
可任选的,间隙86在一个轴向端闭合,以提供额外防护,防止附接元件25迫使凸起84进入支柱间的空间的方向上的轴向位移。
参照图9,在支架件的展开(或非折叠)功能态,支柱可以散开,以及U形顶的拱可以绕一个小于第一角度的第二角度展开,以至少部分的打开孔眼。第二角度可以是约180度或更小。在类似于上面所述的方式中,顶的开口可以促进与凸起84的分离。间隙86的斜切边90也随着支柱70、72环形展开并靠在边90上而作为斜面径向“抬升”支柱离开间隙88。
应该强调的是,前面说明书仅是说明了本发明非限定的优选形式。可以在本发明范围内使用许多变型和等效物。
Claims (42)
1.一种用于经导管植入的瓣膜置换装置,其包括:
支架件,其具有流入端和流出端,所述支架件径向地可压缩至压缩态用于递送至植入部位,并径向地可展开至功能态;
瓣膜小叶,其至少部分安装在所述支架件内;
内裙部,其附接至所述瓣膜小叶,所述内裙部在支架件内至少部分地朝向所述流入端延伸;以及
外裙部,其至少部分在支架件外侧延伸,所述外裙部比内裙部更进一步地朝向所述流入端延伸。
2.根据权利要求1所述的装置,其中所述内裙部和外裙部在轴向方向上部分重叠。
3.根据权利要求1或2所述的装置,其中所述内裙部朝向所述支架件的所述流出端比外裙部延伸更远。
4.根据权利要求1、2或3所述的装置,其中所述支架件开口具有由至少一行网格单元的网格结构限定的Z字形,所述Z字形可由流入端的自由顶和连接至相邻网格单元的连接顶的交替序列限定,所述内裙部仅延伸至对应至少一些连接顶的水平,以及所述外裙部延伸至对应至少一些自由顶的水平。
5.根据前述任意权利要求所述的装置,其中在所述支架件开口的网格单元行至少包括第一和第二网格单元,其具有超出本行中相邻网格单元自由顶的裸露自由顶且不被外裙部包覆,所述裸露自由顶提供附接元件,其用于接合递送装置的支架保持器,所述递送装置用于将瓣膜置换装置递送至植入部位。
6.一种用于经导管植入的瓣膜置换装置,其包括:
支架件,其包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部,所述支架件径向地可压缩至压缩态用于递送至植入部位,并径向地可展开至功能态,所述中间部具有至少两个连合支杆,其每个为叉骨形状,所述叉骨形状包括与相邻支架结构连通的柄以及与相邻支架结构连通的两条腿,
至少两个瓣膜小叶,其由支架件支撑,每个瓣膜小叶包括至少两个翼片,其直接附接至所述连合支杆。
7.权利要求6所述的装置,其中所述支架件包括网格结构,其具有布置在所述中间部和所述第二端之间的至少一行网格单元,每个叉骨形连合支杆分别跨至少三个相邻网格单元的序列,从而叉骨从该序列的外侧网格单元延伸而不附接该序列的所述至少一个中间网格单元。
8.根据权利要求6或7所述的装置,其中所述小叶的翼片附接至叉骨形连合支杆的所述柄。
9.根据权利要求6、7或8所述的装置,其中所述叉骨形连合支杆的腿成形以匹配小叶的侧边。
10.根据权利要求6或任意基于其的权利要求所述的装置,其中所述至少两个连合支杆通过布置在第一端和中间部之间的至少两个稳定拱连接在一起。
11.一种用于经导管植入的瓣膜置换装置,其包括:
支架件,其包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部,所述支架件径向地可压缩至压缩态用于递送至植入部位,并可展开至功能态,所述中间部分具有至少两个连合支杆;
内裙部,其至少部分地在支架件内部延伸;以及
至少两个瓣膜小叶,其包括至少两个翼片,所述翼片凸出穿过内裙部中的狭缝并直接附接至连合支杆。
12.根据权利要求11所述的装置,其中所述两个相邻小叶的翼片汇合并穿过内裙部中的狭缝,以及直接附接至相同的连合支杆。
13.根据权利要求11或12所述的装置,其中每个翼片通过穿过连合支杆的狭槽和/或缝合至连合支杆而直接附接至连合支杆。
14.根据权利要求11、12或13所述的装置,其中所述小叶附接至内裙部,所述内裙部具有由扇形凹口状间隙间隔的连合部,每个间隙由小叶跨越,以及其中内裙部的每个连合部包括至少一个舌片,所述舌片至少部分折绕各自连合支杆。
15.根据权利要求14所述的装置,其中内裙部的每个连合部包括两个舌片,它们至少部分折绕各自连合支杆。
16.根据权利要求14或15所述的装置,其中所述至少一个舌片基本包覆附接至连合支杆的部分翼片。
17.根据权利要求14、15或16所述的装置,其中所述至少一个舌片径向延伸超出附接至连合支杆的翼片的边。
18.一种用于经导管植入的瓣膜置换装置,其包括支架件,所述支架件支撑多个瓣膜小叶,所述支架件径向可压缩至用于通过递送装置递送的压缩态,并径向可展开至功能态,所述支架件包括至少一个附接元件用于结合递送装置的支架保持器,其中所述附接元件包括接合两个支架支柱的U形部,在支架件的压缩态,所述支柱在附接元件上彼此靠近地放置,以使得U形部的弓形绕超过180度的第一角度延伸以限定出接近闭合的孔眼,其具有大于支柱间隔的孔径,以及其中,在支架件的功能态,所述支柱散开,以及所述U形部的弓形绕小于第一角度的第二角度延伸以至少部分地打开所述孔眼。
19.根据权利要求18所述的装置,其中在所述压缩态,所述附接元件的U形基本是马蹄U形。
20.根据权利要求18或19所述的装置,其中在所述功能态,所述附接元件的U形基本是非马蹄U形。
21.一种包括根据权利要求18、19或20的瓣膜置换装置以及用于它的递送装置的系统,所述递送装置包括远端部,其可插入组织构造中并具有用于接收输送至植入部位的瓣膜置换装置的容纳区;支架保持器,其定位在所述容纳区中并具有与支架件的所述至少一个附接元件匹配接合的轮廓。
22.根据权利要求21所述的系统,其中所述支架保持器包括至少一个凸起,其在使用中接收在附接元件的U形部中,所述凸起具有比毗邻附接元件的支柱在支架件处于压缩态时的间隔大的直径,由此限制了支架件相对于递送装置的轴向方向的运动。
23.根据权利要求21或22所述的系统,其中所述支架保持器包括一个或多个表面,其限定出用于在支架件处于压缩态时接收附接元件于其中的通道,所述通道具有锥形开口表面用于在附接元件随着支架件展开而展开时抬升附接元件离开支架保持器。
24.一种用于心脏瓣膜置换的装置,其包括:
-瓣膜件和/或组织瓣膜,其包括至少两个瓣膜小叶,所述瓣膜小叶优选的由心包膜组织制成,最优选的由猪心包膜组织制成,每个瓣膜小叶包括至少两个翼片;以及
-支架件,其包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部,所述中间部具有至少两个连合支杆,其通常地平行于跨越第一端至第二端的轴线排列;
其特征在于所述支架件配置以径向地可压缩至压缩态,并可展开至功能态,其中所述翼片直接附接至所述连合支杆,优选地附接至设置在所述连合支杆上的附接机构。
25.一种用于心脏瓣膜置换的装置,其包括:
-瓣膜件和/或组织瓣膜,其包括至少两个瓣膜小叶,所述瓣膜小叶优选的由心包膜组织制成,最优选的由猪心包膜组织制成,每个瓣膜小叶包括至少两个翼片;以及
-支架件,其包括第一端、第二端以及布置在所述第一和第二端之间的至少一个中间部;
其特征在于所述支架件配置以径向地可压缩至压缩态,并可展开至功能态,所述中间部包括至少两个呈叉骨形状的连合支杆,其包括柄和两个臂,其中所述翼片直接附接至所述连合支杆,优选地附接至设置在所述连合支杆上的附接机构。
26.根据权利要求24或25所述的装置,其特征在于所述连合支杆包括用于所述翼片的附接机构,所述附接机构包括至少一个开口,其适于插入至少一个翼片,所述开口优选配置为长孔洞。
27.根据权利要求24至26中任一项所述的装置,其特征在于所述连合支杆包括用于所述翼片的附接机构,所述附接机构包括至少两个适于缝合线插入的孔洞,所述孔洞优选以圆孔形式。
28.根据权利要求25至27中任一项所述的装置,其特征在于所述支架件包括管状部,其布置在所述中间部和所述第二端之间,所述管状部具有网格单元的网格结构,每个叉骨形连合支杆跨至少三个相邻网格单元的序列,使得叉骨从该序列的外侧网格单元延伸而不连接该序列的至少一个中间网格单元。
29.根据权利要求25至28中任一项所述的装置,其特征在于所述至少两个小叶的所述翼片附接至所述叉骨形连合支杆的所述柄。
30.根据权利要求25至29中任一项所述的装置,其特征在于所述叉骨形连合支杆的所述臂部做成可匹配所述小叶的侧边。
31.根据权利要求24至30中任一项所述的装置,其特征在于所述装置另外包括内裙部,其优选由心包膜组织制成,横跨所述瓣膜小叶的下边至所述第二端,所述内裙部优选地缝合至所述支架装置。
32.根据权利要求24至31中任一项所述的装置,其特征在于所支架件在径向压缩态具有20French的直径,优选具有18French的直径。
33.根据权利要求24至32中任一项所述的装置,其特征在于所述至少两个连合支杆通过布置在所述第一端和所述中间部之间的至少两个稳定拱连接在一起,所述稳定拱通常形成从所述第一端向所述中间部定向的管状通道。
34.根据权利要求31至33中任一项所述的装置,其特征在于所述内裙部包括牵拉所述翼片而让其通过的狭缝。
35.根据权利要求31至34中任一项所述的装置,其特征在于所述瓣膜件配置成使得除了所述瓣膜小叶和所述内裙部之间缝合周围区域外,基本仅存在单层组织。
36.一种用于递送用于心脏瓣膜置换的装置的递送系统,其包括:
-柔性管状导管,其包括近端和远端以及连接部件;以及
-用于根据权利要求1-20或24-34中任一项所述的心脏瓣膜置换的装置,
其特征在于所述装置连接上述连接机构以使得适于定位于心室的该装置部分朝向所述导管的远端定向,以及适于定位于主动脉的所述装置部分朝向所述近端定向。
37.一种心脏瓣膜置换的方法,其包括如下步骤:
-将根据权利要求1-20或24-34中任一项所述的装置以压缩状态插入要置换的心脏瓣膜的部位;
-展开所述瓣膜置换装置的支架件;
其特征在于所述装置通过柔性管状导管沿动脉插入,优选的沿股动脉或锁骨下动脉插入。
38.一种制造瓣膜置换装置的方法,其包括如下步骤:
-提供管状裙部,其优选由心包膜组织制成;
-绕所述管状裙部布置彼此靠近的至少两个小叶;
-将所述至少两个小叶的侧边和底边附接至所述管状裙部;
-将所述管状裙部外翻;以及
-将由此获得的瓣膜件附接至支架件。
39.根据权利要求38所述的方法,其特征在于在将裙部附接至所述支架件前,移除与所述至少两个小叶重叠的所述裙部的至少部分组织。
40.根据权利要求38或39所述的方法,其特征在于所述至少两个小叶每个都包括至少两个翼片,所述翼片布置在所述小叶的自由边区域中的侧边上,其中在裙部中切割出至少两个狭缝。
41.根据权利要求38-40中任一项所述的方法,其特征在于至少一个翼片插入穿过每个狭缝并直接附接至所述支架件。
42.根据权利要求38-41中任一项所述的方法,其特征在于所述管状裙部通过将组织片缠绕具有尺寸和形式对应于瓣膜置换装置的瓣膜件尺寸和形式的心轴制成。
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