CN106510902B - 用于二尖瓣反流治疗装置的方法和设计 - Google Patents

用于二尖瓣反流治疗装置的方法和设计 Download PDF

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CN106510902B
CN106510902B CN201611067160.3A CN201611067160A CN106510902B CN 106510902 B CN106510902 B CN 106510902B CN 201611067160 A CN201611067160 A CN 201611067160A CN 106510902 B CN106510902 B CN 106510902B
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马建录
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Abstract

用于治疗二尖瓣反流的方法和装置包括提供治疗装置,所述治疗装置包括可膨胀的框架以及被容纳在所述框架内的叶瓣组件。所述框架具有篷架部件。所述治疗装置被输送到病人的主动脉瓣膜中的主动脉位置,并且所述框架在天然主动脉瓣膜的位置被展开,同时所述篷架部件将主动脉下隔和/或前部叶瓣和/或二尖瓣的二尖瓣环朝二尖瓣的方向推动。所述叶瓣组件代替了病人的天然主动脉瓣膜的瓣膜功能。

Description

用于二尖瓣反流治疗装置的方法和设计
技术领域
本发明涉及一种二尖瓣反流治疗装置和一种它的使用方法。所述方法和装置通过将所述装置植入到主动脉瓣位置并且朝二尖瓣推动主动脉下隔和/或二尖瓣的前部叶瓣来治疗二尖瓣反流。
背景技术
人类的心脏具有四个腔和四个瓣膜。心脏瓣膜控制血流的方向。功能完善的心脏瓣膜保证正确的血液循环在心脏周期期间被保持。在心脏瓣膜的叶瓣因为疾病,例如先天性心脏病、腱索撕裂、腱索拉伸、左心室扩大、乳头肌损伤、因干扰导致的瓣膜结构损伤、退行性变、叶瓣钙化、瓣环拉伤、乳头肌之间的距离增大等等而无法达到完全接触(接合)的时候,就会发生心脏瓣膜的反流,或者泄漏。不管是什么原因,反流都会影响心脏功能,因为它允许血液沿着错误的方向通过瓣膜回流。根据反流的程度,所述回流可能不仅对心脏功能,而且对心脏结构都产生自毁性的影响。另一方面,异常的心脏结构也可能是反流的原因,并且这两个过程可以“协同作用”而加速异常的心脏功能。心脏瓣膜反流的直接结果是正向心脏输出的减少。根据泄漏的严重性,心脏将足够的血流泵出到身体的其他部分的效果可能被减弱。
参考图1,二尖瓣是心脏中的双层(双叶瓣)瓣膜,其位于左心房(LA)和左心室(LV)之间。在心脏舒张期间,因为在左心房充满血液时(预负荷时)来自左心房的增加的压力,正常工作的二尖瓣会打开。当心房压力增加到超过左心室的压力时,二尖瓣会打开,促使血流被动地流入左心室。心脏舒张期的末期伴有心房收缩,其将从左心房被传输到左心室的剩余血液喷射出来。在心房收缩的末期二尖瓣关闭从而防止血流从左心室向左心房逆流。人的二尖瓣的打开面积通常为4-6cm2。叶瓣有两个,即前部叶瓣和后部叶瓣,其盖住二尖瓣的开口。所述二尖瓣的开口由被称为二尖瓣瓣环的纤维质环围绕。所述两个叶瓣沿周向被贴合到所述二尖瓣瓣环上,并且在心动周期中可以从所述瓣环上通过铰链打开及关闭。在正常工作的二尖瓣中,所述叶瓣被通过腱索连接到左心室内的乳头肌。当左心室收缩时,心室内的压力迫使二尖瓣关闭,而腱索使两个叶瓣保持接合(也就是说,防止两个瓣膜叶瓣脱垂到左心房中并产生二尖瓣反流)并防止薄膜沿着错误的方向打开(从而防止血液流回到左心房中)。二尖瓣反流可能是由天然二尖瓣叶瓣的不成功的接合所导致的。换言之,如图1中所示,当二尖瓣叶瓣未能接合时,血液在心脏收缩期间从心室流回到左心房中。图1具体地示出了具有二尖瓣反流(在心脏舒张期间)的二尖瓣瓣膜,其具有较长的A-P距离。
目前,标准的心脏瓣膜反流治疗的选择包括外科修复/治疗和血管夹。标准的外科修复或替换操作需要开心手术、使用心肺旁通术、以及心脏停止术。由于这些外科手术的侵入性质,死亡、中风、出血、呼吸问题、肾脏问题、以及其他并发症都很多见,足以将许多病人从适用外科手术的范围中排除。
近年来,血管夹技术已经被多家设备公司研究出来。在该方法中,由生物相容性材料制成的可植入的夹钳被插入到两个叶瓣之间的心脏瓣膜中,从而把两个叶瓣(主要是A2和P2叶瓣)的中间部分夹在一起以防止叶瓣脱垂。然而,在血管夹的实际应用中已经暴露了一些缺点,例如定位困难、一旦错误地植入则移除困难、心脏瓣膜反流的复发、在一次手术中需要多个夹钳、要严格地选择病人等等。
综上所述,对于研发一种用于治疗二尖瓣反流的新颖的医疗装置有着很大的需求。迄今为止现有的医疗装置中没有一种完全解决了这个需求。本发明的目的在于给医生提供一种装置和一种方法,其能够避免创伤性的外科手术,并且替代地提供一种医疗装置,其可以通过基于导管的、侵入性较低的手术被植入,以用于二尖瓣反流的治疗。
发明内容
为了实现本发明的目的,提供了一种主动脉瓣膜装置,其被植入在病人的天然主动脉瓣膜的位置来治疗二尖瓣反流。所述装置具有框架,所述框架具有环形支架、从所述环形支架的一端延伸的主动脉凸缘、以及从所述环形支架的另一端延伸的心室凸缘,并且所述心室凸缘向外径向地张开,使得所述心室凸缘的直径逐渐增加,直到它到达一心室端。所述框架还包括篷架部件,其从所述心室端的周缘上的少于所述心室端的周缘的90%的部分延伸出来,并且所述篷架部件设有一个或多个单元组件,所述单元组件由被连接所述心室端的支杆形成。当所述框架被植入在主动脉部分中时,所述篷架部件位于所述心室端的周壁的放置得较为接近病人的主动脉下隔的一侧,使得所述篷架部件朝着所述二尖瓣的方向推动所述主动脉下隔和/或所述二尖瓣的前部叶瓣。所述装置还包括一组被缝合到所述框架的内部中的叶瓣,而且这些叶瓣代替了病人的天然主动脉瓣膜的瓣膜功能。
因此,本发明提供了用于治疗二尖瓣反流的方法和装置。本发明的方法和装置通过将所述装置植入主动脉瓣膜内部并使用所述篷架部件朝着所述二尖瓣的方向推动主动脉下隔和/或二尖瓣的前部叶瓣来治疗二尖瓣反流,从而减小二尖瓣瓣环的尺寸(尤其是A-P距离),并改善天然二尖瓣叶瓣的接合。
附图说明
图1示出了人的心脏,其显示出存在二尖瓣反流的二尖瓣。
图2示出了人的心脏,其带有被植入在主动脉位置的本发明的装置。
图3是根据本发明的一个实施方式的装置的立体示意图。
图4是图3中的装置的框架的立体示意图。
图5是图4中的框架的侧面立体示意图。
图6是图4中的框架的俯视示意图。
图7是图4中的框架的仰视示意图。
图8是可以被和图3中的装置一起使用的可行的叶瓣和裙部组件的立体示意图。
图9A-9C示出了图3中的装置的使用经股动脉方法的输送过程。
图10A-10B示出了图3中的装置的使用经心尖方法的输送过程。
具体实施方式
以下的具体描述是实施本发明的最优的现有设想模式。这些描述不应该被当作是限制性的观点,而是仅仅为了描述本发明的实施方式的基本原理的目的而作出的。本发明的范围被随附的权利要求最优地限定。在特定情况下,公知的装置和机构的具体描述被省略,从而不会使不必要的细节干扰本发明的描述。
近年来,一些经导管的主动脉瓣膜替换装置(TAVI)已经被研发出来并且可以商用。这些可以商用的经导管的主动脉瓣膜装置已经显示出一些有利的临床优越性,并且已经在全世界范围内被广泛地使用于治疗主动脉瓣膜有病患的病人。目前,经导管的主动脉瓣膜装置可以经股动脉或经心尖,或者通过人体中的其他动脉进行传输。临床证据已经显示出经导管的主动脉瓣膜替换手术是安全且有效的手术。
本发明提供一种方法和设计,用于二尖瓣反流治疗装置20,其通过将所述装置植入到主动脉瓣膜中,并且通过所述装置中的篷架部件22朝二尖瓣的方向推动主动脉下隔和/或二尖瓣的前部叶瓣以减小二尖瓣瓣环的尺寸,由此改善天然二尖瓣叶瓣的接合情况,从而治疗二尖瓣的反流。所述装置中的篷架部件22也可以通过推动/支撑主动脉下隔或者二尖瓣的前部叶瓣来减小二尖瓣瓣环的尺寸(尤其是A-P距离),从而治疗二尖瓣的反流。传统的主动脉瓣膜替换手术可以被用在本发明的方法中来输送新的用于二尖瓣反流治疗的装置。一旦新的装置20被植入到主动脉位置,所述篷架部件22就可以推动主动脉下隔/前部叶瓣/二尖瓣的瓣环以减小二尖瓣的A-P距离并改善二尖瓣的叶瓣的接合。
图2示出了在本发明的装置20被植入到主动脉瓣膜位置之后具有较小的A-P距离的天然二尖瓣。所述装置20的篷架部件22朝后部一侧推动二尖瓣的前部结构并减小A-P距离。在心脏收缩期间,二尖瓣的叶瓣可以正确地接合(并且二尖瓣反流被减少或消除)。
图3-8更详细地示出了所述装置20。所述装置20包括框架24、一组被缝合到所述框架24的内部中的叶瓣26、以及用来防止瓣膜腔壁泄漏、减少对周围部位的损伤、以及促进组织生长和愈合的裙部28。
所述框架24具有主动脉凸缘30、瓣环支架32及心室凸缘34。所述主动脉凸缘30、瓣环支架32及心室凸缘34可以由镍钛诺超弹性材料或者不锈钢、钴-铬基合金、钛及其合金、以及其他可以自膨胀或者可以借助球囊膨胀的生物相容性材料制成。其他的聚合生物相容性材料也可以被用来制造所述装置20的这些部件。例如,所述框架20可以从金属或聚合材料的管材上被激光切割下来。被切下的结构之后将会经过形状设置、微喷砂、以及电解抛光等处理以达到理想的轮廓/形状,如图4中所示。作为替换方案,所述框架也可以由平坦的片材制造,而后被卷曲到理想的形状。
所述主动脉凸缘30适合于被放置在病人的主动脉中,位于主动脉瓣膜的流出侧上,并且所述主动脉凸缘30的一部分在主动脉内部延伸。所述主动脉凸缘30可以包含一圈框架单元36,所述框架单元36由相互连接的支杆40组成。所述主动脉凸缘30可以具有等于或者大于主动脉瓣环面积的表面积。
所述瓣环支架32用作锚定结构,并且可以和瓣环、天然叶瓣、以及其他的心脏内部结构、或者瓣膜下结构相互作用,从而提供理想的锚定效果。参考图2和图4,所述瓣环支架32可以设有大致为圆柱形的本体,所述本体由多个框架单元36组成,所述框架单元46由相互连接的支杆40组成。
所述心室凸缘34从所述瓣环支架32的心室端延伸出来,并且能够向外部径向地张开,从而使所述心室凸缘34在直径上能够持续地增大,直到它到达其心室端38,在心室端38其直径是最大的。所述心室端38可以被最靠近心室的框架单元36的尖端限定出来。所述心室凸缘34可以包含最后一圈支杆48,这些支杆48限定了所述瓣环支架32中的最靠近心室的框架单元36,并且这些支杆48向外部张开。辐射透不过的标记可以被整合到心室凸缘34中,以便提供视觉上的帮助来辅助进行所述装置20的输送期间的定位,以及继续进行后续的植入。在使用中,所述心室凸缘34和所述瓣环支架32的高度的一部分可以被生物相容的聚合纤维、织物或其他生物相容材料覆盖,以便提供环绕所述装置20的密封效果,并且促进组织生长及加快愈合效果。
所述篷架部件22从所述心室端38的周壁/边界的一部分延伸出来,并且可以由和所述框架20的剩余部分相同的材料制造或激光切割而成。所述篷架部件22可以被实施为一个或多个单元组件42的形式,所述单元组件42由被连接到位于所述心室端38的各个网格单元的尖端的支杆44组成。所述篷架部件22位于所述心室端38的周壁的较为接近主动脉下隔的一侧。各种形式的辐射透不过的标记或者线圈可以被整合到篷架部件22中,用于在手术期间和之后的后续植入过程期间对所述装置20和所述篷架部件22进行观测、定位或直接安放。所述篷架部件22沿着所述心室端38的周壁的1%到90%延伸。所述单元组件42优选地设有大于所述心室端38的外径的直径,并且能够被向外弯曲。在图3-7中所示的实施方式中,形成所述篷架部件22的所述支杆44以凹陷的方式从所述心室端38径向地向外伸出,使得所述单元组件42的尖端从所述支杆44的直径最大的部分径向地向内延伸。所述单元组件42的尺寸可以小于、大于、或者等于所述瓣环支架32中的所述网格单元36的尺寸,这取决于预期的伸缩性大小。辐射透不过的标记可以被整合到所述瓣环支架32、和/或所述心室凸缘34、和/或所述篷架组件22中,以便在输送期间帮助所述装置20进行定位。此外,也可以存在多余一圈的单元组件42。例如,设置额外圈数的单元组件42将会给篷架组件22提供不同的机械特性,举例来说,通过调节所述单元组件42的尺寸,所述篷架组件22可以要么b比所述框架的其他部分更有弹性,要么比其他部分更加坚硬。此外,所述单元组件42在尺寸上可以更小。作为另一个替代方案,处于不同的圈中的单元组件42可以具有不同的尺寸。
每个支杆40的宽度可以处于从0.2mm到2.5mm的范围内,每个支杆40的厚度可以处于从0.1mm到0.75mm的范围内。每个网格单元36的长度可以处于从2mm到25mm的范围内。沿着所述瓣环支架32的周壁的网格单元36的数量可以处于从3个到20个的范围内。
图4示出了所述装置20的每个组件的通常的尺寸或几何形状的范围。所述主动脉凸缘30可以具有圆形轮廓或者不同于完全的圆形的轮廓。当所述主动脉凸缘30具有圆形轮廓时,所述主动脉部分的直径可以处于从12mm到50mm的范围内。如果所述主动脉凸缘30具有不同于完全的圆形的轮廓,则其长轴可以处于从20mm到50mm的范围内,其短轴可以处于从12mm到40mm的范围内。此外,所述主动脉凸缘30的高度H1可以处于从0.5mm到50mm的范围内。在所述主动脉凸缘30的上方主动脉端,限定出所述主动脉凸缘30的每个网格单元46都具有峰部和谷部,并且在其每个峰部上都具有圆形的非创伤性尖端44。如果有需要,所述主动脉凸缘30可以被纤维或组织材料、或者组织和纤维材料的复合体完全地或部分地覆盖。所述主动脉凸缘30在其朝向外表面的一侧可以具有倒钩或销钉,以便在有需要时帮助挂住主动脉壁。
所述瓣环支架32可以具有处于从5mm到60mm的范围内的高度H2。所述瓣环支架32的横截面轮廓可以是完全的圆形形状或者不同于圆形形状的轮廓。当所述瓣环支架32具有完全的圆形轮廓时,其直径可以处于从12mm到50mm的范围内。当所述瓣环支架32具有不同于圆形形状的轮廓时,其长轴可以处于从15mm到50mm的范围内,其短轴可以处于从12mm到45mm的范围内。所述瓣环支架32的下方部分(也就是较为接近心室一侧的部分)可以被纤维或组织材料、或者组织和纤维材料的复合体全部或部分地覆盖。例如,所述瓣环支架32的一个部分可以被纤维覆盖,而所述瓣环支架32的另一个部分可以被组织覆盖,反之亦然。在使用中,所述纤维材料和组织可以首先被缝合/连接在一起,或者被分别地缝合/连接到所述瓣环支架32的所述下方部分上。所述瓣环支架32的所述下方部分可以沿着一个表面(也就是说内部或外部的表面),或者同时沿着两个表面(也就是说内部和外部的表面)被覆盖。在所述瓣环支架32的底部(对应心室)一端,每个网格单元36都过渡到心室凸缘34。所述心室凸缘34可以具有处于从1mm到20mm的范围内的高度H3。所述心室凸缘34的横截面轮廓可以是完全的圆形形状或者不同于圆形形状的轮廓。当所述心室凸缘34具有完全的圆形轮廓时,其直径可以处于从12mm到60mm的范围内。当所述心室凸缘34具有不同于圆形形状的轮廓时,其长轴可以处于从15mm到60mm的范围内,其短轴可以处于从12mm到50mm的范围内。所述心室凸缘34可以具有锥形的形状。例如,和瓣环支架32连接的一端可以具有小于所述心室凸缘34的心室端的直径的直径。
所述篷架部件22可以具有处于从1mm到30mm的范围内的高度H4。优选地,所述高度H4为所述高度H3的大约50%到150%,同时为所述高度H2的大约10%到70%。
图8示出了可以被和所述装置20一起使用的叶瓣和群部组件的示例性的配置,所述叶瓣和裙部组件可以是三叶形设计。三个叶瓣26可以从固定的组织或聚合物材料上被切下。所述叶瓣26可以被沿着缝合线27的缝线操作缝合在一起,而后再被和裙部材料28缝合在一起,从而形成所述叶瓣和裙部组件。所述叶瓣和裙部组件而后可以通过缝合或其他机械方法被合并到所述框架24中。
所述叶瓣26可以由处理过的心包组织,例如牛的或猪的组织、或者其他生物相容的聚合物材料制成。所述叶瓣26也可以由薄壁状的生物相容的金属部件(例如不锈钢、钴-铬基合金、镍钛诺、钽、以及钛等等),或者由生物相容的聚合物材料(例如聚异戊二烯、聚丁二烯及它们的共聚物、氯丁橡胶和丁腈橡胶、聚氨酯弹性体、硅橡胶、氟橡胶及氟硅橡胶、聚酯、以及PTFE等等)制成。所述叶瓣也可以设有药物涂层或生物制剂涂层以提高其性能、预防血栓形成、以及改善血管内皮增生情况。所述装置20上的所述叶瓣也可以被预先处理或者设有表面涂层/镀层以防止钙化。
所述叶瓣26可以通过机械纺织、缝线缝合、以及化学的、物理的、或者粘合的连接方法被合并到所述框架24中。所述叶瓣26也可以被用药物或其他生物制剂覆盖来防止心脏中的血凝块形成。防钙化材料也可以被涂覆或设置在其表面上以防止钙化。
所述裙部28可以由处理过的组织或聚合物材料、或者这两种材料的复合体制成。
所述装置20可以用和目前经导管的主动脉瓣膜(TAVI)替换装置的输送方式相似的方式被输送到主动脉位置。所述装置20可以被压缩成较低的轮廓(参见图9A)并被装载到包括输送系统套管60和输送导管62的输送系统上,而后通过非侵入性的医疗手术,例如通过在经心尖、经股动脉、或者经桡动脉进行的手术中、或者在颈动脉中使用所述输送导管60,被输送到目标位置。一旦其到达目标植入位置,所述装置20可以从所述输送套管60上被释放,并且能够通过球囊(对于球囊式可膨胀框架24而言)的膨胀或者通过储存在所述装置中的弹性能量(对于具有能够自膨胀的框架24的装置而言)而膨胀到它的正常的(膨胀的)轮廓。所述装置20可以被推出所述输送导管62,或者所述输送导管62可以被撤回从而释放所述装置20。
在从所述输送系统上释放所述装置20的期间,所述装置20的组件将会被按顺序从所述输送系统上释放出来。例如,在经过心尖的输送期间,如图10A-10B中所示,所述主动脉凸缘30将首先从所述输送套管60上被展开,接着是所述瓣环支架32、所述心室凸缘34,而后是所述篷架组件22,依照该顺序进行。相反地,在经过股动脉的输送期间,如图9B-9C中所示,所述篷架组件22将首先被展开,接着是所述心室凸缘34、所述瓣环支架32,而后是所述主动脉凸缘30,依照该顺序进行。所述工序可以在来自X射线和/或TEE、ICE、或者其他已知的成像技术的引导之下被执行。在输送期间,所述输送系统和所述装置20的方向将会被控制,从而使得当所述装置20被从所述输送系统上释放时,所述篷架组件22可以被精确地定位于所述主动脉下隔区域,以便朝着二尖瓣方向推动前部的二尖瓣叶瓣。来自所述篷架组件22的推动作用/力也可以重塑所述二尖瓣瓣环的形状(例如,减小所述二尖瓣的A-P距离等等),使得天然的二尖瓣叶瓣可以更好地接合和工作。
上面的具体描述仅用于实施本发明的目前所考虑的最佳方式。该描述不应该被视为限制性的意见,而是仅仅为了解释本发明的实施方式的基本原理的目的而被作出的。本发明的范围由随附的权利要求最佳地限定。在特定情况下,公知的装置、组件、机构和方法的具体描述会被省略,以便防止不必要的细节干扰本发明的描述。

Claims (16)

1.一种主动脉瓣膜装置,包括:
用于植入在主动脉部分中的框架,其具有瓣环支架、从所述瓣环支架的一端延伸,用于放置在主动脉中的主动脉凸缘、以及从所述瓣环支架的另一端延伸,用于放置在左心室中的心室凸缘;所述心室凸缘在径向上向外张开,使得所述心室凸缘在直径上逐渐增加,直到其到达心室端;
所述框架还包括篷架组件,其从所述心室端的周壁上的少于所述心室端的所述周壁的90%的部分延伸,且所述篷架组件设有一个或多个由连接到所述心室端的支杆组成的单元组件,当所述框架被植入在主动脉部分中时,所述篷架组件被置于所述心室端的所述周壁的放置得较为接近病人的主动脉下隔的一侧,用于减小二尖瓣瓣环的尺寸;以及
被缝合到所述框架的内部中的一组叶瓣。
2.如权利要求1所述的装置,其中组成所述篷架组件的所述支杆以凹陷的方式从所述心室端在径向上向外延伸,使得所述单元组件的尖端在径向上向内延伸。
3.如权利要求1所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有比所述瓣环支架中的所述网格单元更小的尺寸。
4.如权利要求1所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有比所述瓣环支架中的所述网格单元更大的尺寸。
5.如权利要求1所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有和所述瓣环支架中的所述网格单元相同的尺寸。
6.如权利要求1所述的装置,其中所述心室凸缘由多个网格单元限定出来,并且所述心室端由所述网格单元的尖端限定出来。
7.如权利要求6所述的装置,其中所述心室凸缘和所述瓣环支架的一部分高度被生物相容的聚合物纤维、组织或其他生物相容的材料覆盖。
8.如权利要求1所述的装置,其中所述篷架组件具有一高度而所述瓣环支架具有另一高度,并且其中所述篷架组件的高度为所述瓣环支架的高度的10%到70%。
9.一种主动脉瓣膜装置,其被植入在病人的天然主动脉瓣膜的位置来治疗二尖瓣反流,包括:
用于植入在主动脉部分中的框架,其具有瓣环支架、从所述瓣环支架的一端延伸,用于放置在主动脉中的主动脉凸缘、以及从所述瓣环支架的另一端延伸,用于放置在左心室中的心室凸缘;所述心室凸缘在径向上向外张开,使得所述心室凸缘在直径上逐渐增加,直到其到达心室端;
所述框架还包括篷架组件,其从所述心室端的周壁上的少于所述心室端的所述周壁的90%的部分延伸,且所述篷架组件设有一个或多个由连接到所述心室端的支杆组成的单元组件,当所述框架被植入在主动脉部分中时,所述篷架组件被置于所述心室端的所述周壁的放置得较为接近病人的主动脉下隔的一侧,使得所述篷架组件朝着二尖瓣的方向推动所述二尖瓣的前部叶瓣,用于减小二尖瓣瓣环的尺寸;以及
被缝合到所述框架的内部中的一组叶瓣,并且所述叶瓣承担病人的天然主动脉瓣膜的瓣膜功能。
10.如权利要求9所述的装置,其中组成所述篷架组件的所述支杆以凹陷的方式从所述心室端在径向上向外延伸,使得所述单元组件的尖端在径向上向内延伸。
11.如权利要求9所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有比所述瓣环支架中的所述网格单元更小的尺寸。
12.如权利要求9所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有比所述瓣环支架中的所述网格单元更大的尺寸。
13.如权利要求9所述的装置,其中所述瓣环支架由多个网格单元限定出来,并且其中所述单元组件具有和所述瓣环支架中的所述网格单元相同的尺寸。
14.如权利要求9所述的装置,其中所述心室凸缘由多个网格单元限定出来,并且所述心室端由所述网格单元的尖端限定出来。
15.如权利要求14所述的装置,其中所述心室凸缘和所述瓣环支架的一部分高度被生物相容的聚合物纤维、组织或其他生物相容的材料覆盖。
16.如权利要求9所述的装置,其中所述篷架组件具有一高度而所述瓣环支架具有另一高度,并且其中所述篷架组件的高度为所述瓣环支架的高度的10%到70%。
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