CN115192261A - 具有非均一支柱的心脏瓣膜框架设计 - Google Patents

具有非均一支柱的心脏瓣膜框架设计 Download PDF

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CN115192261A
CN115192261A CN202210797111.4A CN202210797111A CN115192261A CN 115192261 A CN115192261 A CN 115192261A CN 202210797111 A CN202210797111 A CN 202210797111A CN 115192261 A CN115192261 A CN 115192261A
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struts
valve
frame
recesses
sutures
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Y·高
P·周
T·赵
J·吴
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Edwards Lifesciences Corp
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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Abstract

本发明的名称是具有非均一支柱的心脏瓣膜框架设计。根据一个实施例，一种可植入的假体瓣膜组件包括框架组件，该框架组件包括多个支柱和通过缝线固定在框架组件内部的假体瓣膜。缝线处于框架组件的外周界的最外表面的内侧。在某些实施例中，支柱包括可以在其中设置缝线的凹部。在其他实施例中，支柱可以具有缝线穿过其中的孔。可植入的假体瓣膜组件也可以在导管内塌缩，使得框架组件的周界的最外表面接触导管，但是缝线与导管间隔开或与框架的外表面齐平。

Description

具有非均一支柱的心脏瓣膜框架设计
本申请是分案申请，原申请的申请日为2018年8月14日、申请号为2018800619018、发明名称为“具有非均一支柱的心脏瓣膜框架设计”。
技术领域
本公开涉及可植入装置，并且更具体地，涉及用于植入循环系统(诸如天然心脏瓣膜环)中的瓣膜假体。
背景技术
人类心脏可能患有各种瓣膜疾病。这些瓣膜疾病可能导致严重的心脏功能失常，并且最终需要用人造瓣膜替代天然瓣膜。存在许多已知的人造瓣膜以及将这些人造瓣膜植入人体内的许多已知方法。
各种外科技术可以用于修复患病或受损的瓣膜。在瓣膜置换术中，受损的小叶被切除，并且塑造瓣环以容纳置换瓣膜。由于主动脉瓣狭窄和其他心脏瓣膜疾病，每年成千上万的患者进行手术，其中有缺陷的天然心脏瓣膜被生物修复的或机械的假体瓣膜代替。治疗有缺陷的瓣膜的另一种不太严重的方法是通过修复或重建，这通常用于最小钙化的瓣膜上。
当置换瓣膜时，假体瓣膜的外科植入通常需要开胸手术，在此期间心脏停止并且患者被置于体外循环/心肺旁路(“心肺机”)上。在一种常见的外科手术程序中，患病的天然瓣膜小叶被切除，并且假体瓣膜被缝合到瓣膜环处的周围组织。据估计，超过50％的80岁以上主动脉瓣狭窄受试者无法进行主动脉瓣置换手术。
由于与传统的心脏直视手术相关的缺点，经皮和微创手术方法引起了广泛的关注。在一种经血管技术中，假体瓣膜被配置为通过导管插入的方式以较少侵入性的程序植入。例如，美国专利US.7,993,394、US5,411,522、US6,730,118和US9,393,110(它们通过引用并入本文)描述了可塌缩的经导管心脏瓣膜，该心脏瓣膜可以以压缩状态从导管经皮引入，并且通过球囊膨胀或利用自扩展框架或支架在期望位置处扩展。
经导管心脏瓣膜的重要设计参数是压缩、折叠或卷曲轮廓的直径。卷曲轮廓的直径很重要，因为它直接影响医师推进瓣膜通过股动脉或静脉的能力。更具体地，较小的轮廓允许治疗更广泛的患者。
一些经导管心脏瓣膜组件包括通过将软部件缝纫或缝制到支架或框架而被固定到可塌缩支架或框架组件的假体瓣膜。缝线材料是最常用的，但是可以使用任何合适的方式将假体瓣膜附连到可塌缩的支架或框架组件。美国专利US7,993,394和US9,393,110描述了经导管心脏瓣膜组件的实施例，其中假体心脏瓣膜通过围绕支柱和/或节点绕圈并穿过假体瓣膜的缝线而被固定到多个轴向(即，竖直的)和成角度的周向支柱和/或节点。
发明内容
公开了一种包括非均一(non-uniform)的支柱和/或节点的可植入的假体心脏瓣膜组件。
在某些公开的实施例中，假体心脏瓣膜组件包括可塌缩并且可扩展的框架或支架以及固定在可塌缩并且可扩展的框架或支架内的假体瓣膜。可塌缩并且可扩展的框架或支架可以由非均一的支柱形成。在某些实施例中，可塌缩并且可扩展的框架或支架由非均一的支柱和附连至假体瓣膜的连合部(commissure)的连合部附连窗形成。在某些实施例中，可塌缩并且可扩展的框架或支架由附连到假体瓣膜的连合部的非均一支柱和附连柱形成。在某些实施例中，可塌缩并且可扩展的框架或支架组件由镍钛诺或优选地由镍钴合金形成。
在一些实施例中，假体心脏瓣膜具有由爱德华兹生命科学公司(EdwardsLifesciences)制造的Sapien 3瓣膜的瓣膜部件。所公开的发明可以与这种类型的瓣膜或任何其他合适类型的瓣膜一起使用。
在某些实施例中，瓣膜具有从瓣膜组件的第一端延伸到第二端的多个非均一的支柱。一些支柱可以从第一端笔直地(即，轴向地)延伸，并且一些支柱可以是成角度的，或者垂直于轴向方向延伸。支柱可以是多工件的，或者可以被形成为一个整体工件。支柱可以具有矩形横截面、圆润的横截面、规则形状的横截面、不规则形状的横截面或沿支柱的长度改变形状的横截面。支柱可以由编织金属丝或压接金属丝形成。支柱可以在称为节点的接合点处相遇。
多个非均一的支柱和/或节点可以具有沿其长度具有相同或不同形状的凹陷。设置在这些凹陷中的缝线处于由非均一支柱形成的假体心脏瓣膜框架的最外表面的内侧。这样，当假体心脏瓣膜组件塌缩在导管内时，凹入的缝线不接触导管的内表面。或者，缝线可以与假体瓣膜框架的最外表面齐平。
多个非均一的支柱和/或节点可以沿其长度具有通道。穿过这些通道设置的缝线在假体心脏框架的周界的最外表面的内侧，使得缝线不接触导管的内表面。
在某些实施例中，可选的附连柱中的孔之间的区域是凹入的，从而使得穿过这些孔设置的缝线处于假体心脏瓣膜框架的最外表面的内侧。
根据下面的详细描述，这些特征和所描述的实施例的其他特征将变得更加明显，下面的详细描述参照附图进行。
附图说明
图1是现有技术的瓣膜组件的实施例的透视图；
图2是现有技术的瓣膜组件的实施例的透视图；
图2A是现有技术的瓣膜组件的实施例的透视图；
图3是图1所示的现有技术的瓣膜组件的放大剖视图；
图3A是现有技术瓣膜的实施例；
图4是具有带凹部的非均一支柱的心脏瓣膜组件的实施例的放大剖视图；
图5是具有倒圆/圆润(rounded)的连续螺旋形凹部的非均一支柱的实施例的侧视图；
图6是沿图5中的线6-6所指示的平面截取的横截面视图；
图7是沿图4的线7-7所指示的平面截取的横截面视图；
图8是与图7所示的实施例相似的非均一支柱的实施例的横截面视图，其中支柱具有圆润的凹部；
图9是与图7所示的实施例相似的非均一支柱的实施例的横截面视图，其中非均一支柱具有内凹部和外凹部；
图10是沿图4的线10-10所指示的平面截取的横截面视图；
图11是具有圆形横截面的非均一支柱的实施例的侧视图，该支柱具有多个凹部，每个凹部沿着支柱的周边；
图12是沿线12-12所指示的平面截取的横截面视图；
图13是沿线13-13所指示的平面截取的横截面视图；
图14是由编织的金属丝形成的具有圆形横截面的非均一支柱的实施例的侧视图，该支柱具有多个凹部，每个凹部沿着支柱的周边；
图15是沿线15-15所指示的平面截取的横截面视图，其示出了松散包装的单根金属丝；
图16是沿线16-16所指示的平面截取的横截面视图，其示出了紧密包装的单根金属丝；
图17是扩展的心脏瓣膜组件的实施例的横截面视图，其包括瓣膜和非均一支柱的示意表示图；
图18是塌缩在导管中的图17的瓣膜组件的横截面视图；
图19是具有穿过非均一支柱的多个孔的圆形横截面支柱的实施例的侧视图；
图20是沿着图19中的线20-20所指示的平面截取的横截面视图；
图21是沿着图19中的线21-21所指示的平面截取的横截面视图；
图22是中空的圆形横截面支柱的实施例的侧视图，该支柱具有穿过支柱的多个孔；
图23是沿图22中的线23-23所指示的平面截取的横截面视图；
图24是沿着图22中的线24-24所指示的平面截取的横截面视图；
图25是扩展的心脏瓣膜组件的实施例的剖视图，其包括瓣膜和具有孔的支柱的示意表示图；并且
图26是塌缩在导管中的图25的瓣膜的横截面视图。
具体实施方式
如本文所使用的，除非上下文另外明确指出，否则单数形式“一”，“一个”和“所述/该”指代一个或多于一个。
如本文所用，术语“包含”表示“包括”。例如，包含或包括A和B的装置含有A和B，但能够可选地含有C或除A和B以外的其他部件。包括或包含A或B的装置可以含有A或B或者A和B，并且可选地含有一个或多个其他部件(诸如C)。
参考图1、图2A和图4，本申请涉及具有框架12的可植入假体装置10，框架12被配置成向内偏移缝线17，缝线17被用于将瓣膜部件附连到框架12。如本申请中所使用的，术语“缝线”包括但不限于聚合物材料(例如，伊西邦(Ethibond)缝线)、线、绳、纤维、金属丝、其他可卷绕材料、有机和无机材料或者对于医疗应用来说可接受的并且适合于将瓣膜组件各种实施例中使用的材料接合在一起的任何其他材料。
框架12可以采用多种不同形式。尽管本申请主要以心脏瓣膜为例进行说明，但是框架12可以是支架、对接部位等的框架。缝线17可以将各种不同的结构附连到框架12。例如，缝线17可以将瓣膜部件、覆盖材料、瓣膜等附连到框架12。如图4所示，缝线17的向内偏移使缝线与瓣膜递送和/或再捕获系统之间的接触或相互作用最小化，并且可以稍微减小卷曲的瓣膜的整体轮廓。在一个示例性实施例中，缝线的最外表面可以与瓣膜框架的最外表面齐平或基本齐平。减少了由于磨耗或磨损而造成的缝线损坏或断裂，并且还减少了缝线对递送或重新捕获系统(包括对可扩展护套的末端或递送筒的末端)造成损坏的可能性。通过最小化框架外直径上的缝线暴露，以及通过最小化缝线与递送或重新捕获系统之间的相互作用，还减小了当瓣膜穿过递送或重新捕获系统时在瓣膜上的推力或阻力。在递送情况、重新捕获情况和完全部署情况下的压接或扩展期间，这还会导致瓣膜组件上的最大应力或应变降低。
本申请中描述的概念可以与多种不同的瓣膜组件一起使用。美国专利US7,993,394(参见图1、图2和图3)和美国专利US9,393,110(参见图2A和图3A)公开了可以使用本申请公开的概念的许多瓣膜组件中的两个。参照图1、图2和图2A，美国专利US7,993,394和US9,393,110公开的假体瓣膜10各自包括框架或支架12、由框架支撑的小叶结构14以及裙部16。瓣膜10通常被植入在天然主动脉瓣膜的瓣环中，但是也可以适于被植入在心脏的其他天然瓣膜中或在身体的各种其他管道或孔口中。
每个瓣膜10具有“第一”端80和“第二”端82。在本申请的上下文中，术语“第一”和“第二”分别与术语“流入”和“流出”互换使用。因此，例如，在图1、图2和图2A所示的实施例中，瓣膜的第一端80是其流入端，而瓣膜的第二端82是其流出端。
瓣膜10被配置成可径向塌缩至塌缩或卷曲状态以在递送导管上引入体内并且可径向扩展至扩展状态以将瓣膜植入在体内的期望位置(例如，天然主动脉瓣膜)处。框架12可以由可扩展的材料制成，该可扩展的材料允许将瓣膜卷曲到较小的轮廓以用于递送瓣膜并且使用诸如球囊的扩展装置来扩展瓣膜。也可以考虑可机械扩展的框架。下文描述了可以用于形成框架的示例性可塑性扩展材料。
可替代地，瓣膜10可以是所谓的自扩展瓣膜，其中框架由自扩展材料(诸如镍钛诺)制成。自扩展瓣膜可以被卷曲到较小的轮廓，并且用约束装置(诸如覆盖瓣膜的护套)保持在卷曲状态。当瓣膜被定位在目标部位或目标部位附近时，约束装置被移除，以允许瓣膜自扩展至其扩展的功能尺寸。
在图1、图2、图2A和图3A的示例中，框架12是环形的类似支架的结构，其包括多个竖直的并且成角度的支柱40。在本申请中，术语“支柱”涵盖竖直支柱、成角度支柱、附连柱、连合部窗以及美国专利US7,993,394和US9,393,110所述的任何类似结构。支柱可以是框架12的任何细长构件或部分。在所示的示例中，支柱在节点或连接部分32处连接在一起。框架12可以具有由成角度支柱和竖直支柱组成的一排或多排。图1、图2、图2A和图3A所示的框架12的附加细节可以在美国专利US7,993,394和US9,393,110中找到。
假体瓣膜10可以具有叶片瓣膜构造。瓣膜10可以由在接缝(也称为连合部凸片)处彼此连接的多片柔性的柔顺材料形成，以形成可塌缩的假体瓣膜小叶60。瓣膜10可以使用例如缝线17和/或柔性连接器34(参见图2A)在接缝处连接至它们各自的框架12。可替代地，瓣膜10可以是机械型瓣膜，而不是叶片型瓣膜。
瓣膜10可以由生物物质制成，诸如天然组织、心包组织(例如牛、猪或马的心包膜)、采集的天然瓣膜或其他生物组织。可替代地，瓣膜10可以由本领域公知的生物相容性合成材料(例如，生物相容性聚合物)制成。瓣膜10可以被成形为适合框架12的廓线，以便在直径上与框架组件匹配。通过瓣膜10的流量沿从第一端80到第二端82的方向前进。
小叶60可以在它们的相邻侧面处彼此固定以形成小叶结构的连合部84(小叶汇合的边缘)。例如，如图3所示，小叶结构14的连合部84可以使用缝线固定到支柱40。缝线17也可以用于将裙部材料16附连到框架。在另一个示例中，如图2A所示，小叶结构14的连合部84可以与(图3A的)连合部窗部分33或框架中的其他附连区域对准，并且使用柔性连接器34(图2A所示)固定在其上。
图3以放大的剖视图进一步图示了可植入的假体瓣膜10，其中裙部16已被移除，但是用于将裙部材料16和小叶60附连到框架12的缝线17仍然保留。图3还图示了如何可以围绕框架组件12的支柱40缠绕缝线17。缝线17可以穿过小叶组件14和/或裙部16的部分以将它们固定到框架。缝线17通过穿过间隔开的附连孔绕圈而将连合部84固定至竖直支柱。图1、图2和图2A中所示的瓣膜的构造的其他细节可以在美国专利US7,993,394和US9,393,110中找到。
可以用于形成框架的合适的材料包括但不限于不锈钢、镍基合金(例如，镍钴铬合金)和聚合物或其组合。在特定实施例中，框架12可以由镍钴铬钼合金制成，诸如MP35NTM(SPS Technologies的商品名)，其等效于UNS R30035(由ASTM F562-02覆盖)。MP35NTM/UNSR30035按重量计包含35％的镍、35％的钴、20％的铬和10％的钼。
再次参照图1、图2和图2A，内裙部16可以包括坚韧的抗撕裂的材料，诸如PET，尽管可以使用各种其他合成或天然材料。内裙部16的主要功能是有助于将小叶结构14固定到框架12，并且通过阻止血液流过小叶下边缘下方的框架12的开放孔眼(open cell)而有助于在瓣膜和天然瓣环之间形成良好的密封。
现在参考图4，在一个示例性实施例中，非均一的支柱40允许附连缝线17将假体心脏瓣膜12和/或裙部16固定至可塌缩并且可扩展的框架或支架，使得当假体瓣膜组件被塌缩并插入导管中以便递送至植入部位时缝线17从导管的内表面或内直径凹入。或者，缝线17可以与框架12的外表面齐平。除了下面描述的创造性特征之外，假体心脏瓣膜组件还可以包括与以上在图1、图2、图2A、图3和图3A中描述的瓣膜和框架结构不同的瓣膜和框架结构。在一些实施例中，本发明构思可以应用于由Edwards Lifesciences制造的Sapien 3瓣膜。所公开的发明可以与任何其他导管植入装置一起使用，包括任何其他瓣膜、支架、对接部位或框架状结构。
图4图示了假体心脏瓣膜组件30的一个实施例，该假体心脏瓣膜组件30具有多个轴向延伸并且成角度的支柱40和节点32。支柱40从第一端80延伸到第二端82，并且形成假体心脏瓣膜组件30的周界。图示的周界是柱形形状，但是也可以形成其他形状。例如，框架的周界可以是椭圆形、肾形或者被成形为近似瓣膜环(诸如二尖瓣瓣环、肺动脉瓣瓣环或三尖瓣瓣环)的形状。由支柱40形成的周界具有径向最外表面41和多个凹部42和/或凹部43。在此应用中，径向方向垂直于从第一端80到第二端82的行进方向。“径向向内”的对象比“径向向外”的对象更靠近瓣膜的中心。在图4中，凹部42和43处于周界41的最外表面的径向内侧，使得缝线17可以将瓣膜10固定至框架组件12，而不会径向延伸超过周界41的最外表面。在一个示例性实施例中，当假体瓣膜组件30被塌缩并插入导管中以进行递送时，缝线17不接触导管的内表面。在另一个示例性实施例中，缝线与周界41的最外表面齐平。
支柱中的凹部还允许固定缝线17在手动或自动生产/组装中更快且更准确的放置(例如，更容易计算适当数量的缝线，使缝线沿着框架支柱间隔或适当地控制缝线张力)。另外，在递送或重新捕获过程中或在完全部署时，凹部中的缝线17不太可能相对于框架组件改变位置。缝线也不太可能在框架组件中引起点蚀(pitting)，这是因为损耗力和摩擦力被最小化(通过采用凹入的支柱，摩擦力不是将缝线固定在适当位置的唯一力，因此在大小上不需要很大)。
在某些实施例中，以上参考图4描述的支柱40的横截面不是矩形的，而是圆润的/倒圆的(rounded)、圆形的、具有多边形形状、具有不规则形状或具有沿着支柱的长度变化的形状。支柱的横截面也可以保持相同的形状，但是沿着支柱的长度或者从假体心脏瓣膜组件的第一端80到第二端82变化尺寸。
另外，虽然在图4中的凹部42被显示为是均匀间隔的，但是其他实施例中的凹部可以被不规则地间隔或者对于不同的支柱可以被不同地间隔。支柱40和节点32可以在非凹入的横截面中制造得更厚以容纳凹部。凹部通常可以被放置在较厚的支柱或节点中，以确保支柱或节点的结构完整性。
参考图7，沿着图4中的线7-7截取的凹部42的横截面示出了具有方形转角71的矩形凹部(图7)。在其他实施例中，凹部可以是圆润的、半圆形的、成角度的、多边形的、不规则形状、或者具有变化的横截面，并且可以具有各种转角形状。下面参考图6至图9描述包括具有不同横截面的凹部的实施例的示例。
如图4所示，凹部42是在支柱40的周界41的径向最外表面中的凹陷。在另外的实施例中，凹部可以是非均一支柱的任何表面中的凹陷。这样的凹部可以形成沿支柱的表面的螺旋状且连续的凹陷、在支柱的径向向内的表面中的凹陷、在支柱的多个侧面上的多个凹陷、围绕支柱的周边或周界的连续的凹陷或其他构造。
图5和图6示出了具有圆形横截面和螺旋形的凹部42的支柱40的实施例。例如，图5所示的支柱具有非凹入部分51。在该实施例中，瓣膜周界的最外表面是沿着支柱40的非凹入部分的线，该线距心脏瓣膜组件的中心最远。具有螺旋路径的凹部42处于非凹入部分51的径向内侧，使得在凹部42中的固定缝线17将处于非凹入部分51的径向内侧。具有螺旋形状的凹部42中的缝线17处于瓣膜组件的周界的最外表面的径向内侧。尽管螺旋形的实施例在图5和图6中作为规则的且连续的螺旋形凹部示出，但是螺旋形凹部可以在形状和间隔上是中断的或不规则的。
图6示出了沿着线6-6所指示的平面截取的非均一支柱40的横截面。图示的凹部42是具有非圆润转角的圆润凹部。在替代实施例中，这种凹部可以具有不同形状的横截面，该横截面具有不同的转角构造，诸如圆润的和/或倒角的转角。
图8是类似于图7的视图的横截面视图。图8图示了支柱40可以具有圆润的带圆润转角的凹部。凹部在框架12的周界41的最外表面中。图9是类似于图7的视图的横截面视图。图9图示了支柱40可以在内表面91和外表面41上都具有凹部，诸如由图7至图9所示的任何形状。在图9的实施例中，支柱具有圆润的凹部42，该凹部42具有圆润的转角81。凹部42可以围绕支柱的周边延伸，或者两个离散的凹部可以被形成在支柱的相对侧上。表面91是支柱的径向最内表面。
图10是沿图4中的线10-10所指示的平面截取的竖直支柱40和缝线17的实施例的横截面视图。在图4和图10所示的示例中，凹部43在缝线17穿过的两个孔110之间延伸。凹部43被示为具有方形转角102的矩形。然而，凹部可以具有任何形状。如图10所示，凹部40允许在孔之间延伸并设置在凹部43中的缝线17处于周界41的径向最外表面的内侧或与周界41的径向最外表面齐平。因此，缝线17将不接触(或将以最小的力接触)导管的内表面。
图11至图13示出了具有圆形横截面并且整体形成的非均一的支柱40的实施例的侧视图和横截面视图。支柱具有多个凹部42，每个凹部42沿着支柱的周边。沿着支柱的周边或周界的凹部可以进一步简化缝线17的放置。图12是沿着图11中的线12-12所指示的平面截取的支柱40的非凹入部分112的横截面视图。图13是沿图11中的线13-13所指示的平面截取的支柱40的凹入部分111的横截面视图。非凹入部分112的横截面的直径明显大于凹入部分111的横截面的直径，使得支柱40的凹部42中的缝线17将处于非凹入部分112的最外表面的径向内侧或与非凹入部分112的最外表面齐平。
如本文所述的支柱可以由上述适于形成框架组件的任何材料(期望地是镍钴基合金或镍钛诺材料)形成。在本文公开的某些实施例中，每个支柱由一个工件整体地形成。在其他实施例中，支柱可以由多个工件形成，或者可以由多根金属丝(诸如，编织的或以其他方式捆扎的金属丝)形成。
图14至图16是具有圆形横截面的非均一的支柱40的实施例的侧视图和横截面视图，所述支柱40由金属丝143形成。金属丝143可以被编织或以其他方式捆扎。支柱40具有多个凹部141，每个凹部沿着支柱的周边。图15是沿图14中的线15-15所指示的平面截取的支柱40的非凹入部分142的横截面视图。在图15中，各个金属丝143被松散地包装以形成更大的直径。图16是沿着图14中的线16-16所指示的平面截取的支柱40的凹入部分141的横截面视图。在图16中，各个金属丝143被更紧密地包装以形成更窄的直径。非凹入部分142的横截面的直径明显大于凹入部分141的横截面的直径，使得支柱40的凹入部分141中的缝线17将处于非凹入部分142的最外表面的径向内侧或至少与非凹入部分142的最外表面齐平。
可替代地，支柱的实施例可以使用编织金属丝形成，其中金属丝的变化直径形成支柱的凹入部分和非凹入部分，而不是由包装/编织的相对紧密度来形成。在这样的支柱的一些部分处，金属丝将具有较宽的直径从而自然地形成支柱的非凹入部分，并且在这样的支柱的其他部分处，相同的金属丝将具有较窄的直径，从而自然地形成支柱的凹入部分。在另外的实施例中，金属丝直径和金属丝包装/编织的紧密度的组合可以用于产生凹入部分和非凹入部分。
图17是扩展的心脏瓣膜组件170的实施例的示意性横截面视图。瓣膜组件170包括瓣膜174(示意性地图示)、形成框架组件的非均一支柱40以及缝线17。支柱具有凹入部分171和非凹入部分172。缝线17将瓣膜174固定到支柱40。图18图示了在导管180内处于塌缩形式的瓣膜组件170。导管180的内表面181与由支柱40形成的周界的最外表面齐平。当缝线17被设置在凹部42中时，缝线17将瓣膜174固定到支柱40而不接触导管180的内表面181。
在本文所述的又一实施例中，构成框架组件的(成角度的并且轴向延伸的)支柱40和节点32可以包含孔，缝线17可以穿过这些孔以将瓣膜或其他结构固定至框架组件。图19示出了具有圆形横截面的支柱40和穿过支柱40的多个孔191的实施例的侧视图。缝线17可以穿过孔191以将瓣膜固定至支柱40，使得缝线17从支柱40的径向最外表面194向内(即，孔的轴线大体上平行于由支柱40形成的框架的外表面，而不是大体上垂直于框架的外表面)。图20是沿着图19中的线20-20所指示的平面截取的没有任何孔的支柱40的一部分的横截面视图。该横截面是实心的，没有任何空白空间，但其也可以是中空的或具有其他非实心构造。图21是沿着图19中的线21-21所指示的平面截取的带有孔的支柱40的一部分的横截面视图。箭头B表示图21中的横截面的平面中的周向方向(即围绕整个心脏瓣膜组件的周边)。孔191在整个周向方向上从第一孔开口192到第二孔开口193直接穿过支柱40。这样，缝线17与框架的外周边间隔开。
在替代实施例中，支柱可以包含不严格遵循周向方向的孔。孔可以具有基本上与周向方向成一直线的第一孔开口，并且然后具有与第一孔开口成角度地移位的第二孔开口，以使其更与径向方向成直线，或者更多地指向心脏瓣膜组件的第一端80或第二端82，或两者的组合。孔可以在支柱中间形成成角度的或圆润的转弯，或者可以形成从第一孔开口到第二孔开口通过支柱的直线。在另外的实施例中，孔沿着支柱不均匀地间隔，因为它们与支柱40中的孔191相同。在包括孔的假体心脏瓣膜组件的所有实施例中，孔被取向为使得通过孔设置的用以将瓣膜或裙部16固定至支柱40的缝线17处于由支柱形成的框架的周界的径向最外表面的内侧。
在本发明的假体心脏瓣膜的另外的实施例中，构成框架组件的非均一的支柱和/或节点可以是中空的。中空的非均一支柱可以具有凹部、孔或两个特征兼有。图22示出了具有圆形横截面的中空的支柱40的实施例的侧视图，其中具有穿过支柱40的多个孔221。缝线17可以穿过孔221以将瓣膜和/或裙部16固定到支柱40，使得缝线17从支柱40的径向最外表面224向内(即，孔的轴线大体平行于支柱40形成的框架的外表面，而不是大体垂直于框架的外表面)。图23是沿着线23-23所指示的平面截取的没有孔的中空支柱40的一部分的横截面视图。通道225延伸穿过支柱。图24是沿着线24-24所指示的平面截取的带有孔221的支柱40的一部分的横截面视图。箭头B表示图24中的横截面的平面中(相对于整个心脏瓣膜组件)的周向方向。孔221在整个周向方向上从第一孔开口222到第二孔开口223直接穿过支柱40。这样，缝线与外周边间隔开。
图25是扩展的心脏瓣膜组件250的实施例的横截面视图，该扩展的心脏瓣膜组件250包括示意性图示的瓣膜254、形成框架的支柱40以及缝线17。支柱40具有在大体周向方向上穿过支柱40的孔251。缝线17将瓣膜254固定到支柱40。图26图示了在导管180内处于塌缩形式的瓣膜组件250。导管180的内表面181与由支柱40形成的周界的径向最外表面齐平并且与其接触。当缝线17穿过孔251设置时，缝线17将瓣膜254固定到支柱40而不接触导管180的内表面181。
已经图示说明并描述了所说明的实施例的原理，明显的是可以在布置和细节上修改实施例，而不脱离这种原理。
此外，尽管本发明的假体瓣膜组件的横截面被示出为大体圆形，但是这些假体瓣膜组件可以具有D形、椭圆形、肾形、任何天然心脏瓣膜的形状或适合于匹配相关的被置换的天然瓣膜的廓线的任何其他的形状。
为了本说明书的目的，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、设备和系统不应以任何方式解释为限制性的。相反，本公开涉及单独和彼此的各种组合和子组合的各种公开实施方式的所有新颖和非显而易见的特征和方面。方法、设备和系统不限于任何特定的方面或特征或其组合，公开的实施方式也不要求存在任何一个或多个特定的优点或解决问题。
尽管为方便呈现以特定的顺序排列描述了本公开实施方式中的一些的操作，但应理解，这种描述方式包括重新布置，除非下文所示的特定语言要求特定的顺序。例如，顺序描述的操作在一些情况下可以重新布置或同时执行。此外，为简单起见，附图可能未示出能够将本公开的方法与其它方法结合使用的各种方式。另外，说明书有时使用像“提供”或“实现”的术语以描述本公开的方法。这些术语是所执行的实际操作的上位抽象概念。对应于这些术语的实际操作可以根据特定的实施方式而变化，并且可由本领域普通技术人员容易地识别。
鉴于许多可能的实施例，应认识到，所说明的实施例仅包括本发明的示例，而不应被视为对本发明范围的限制。相反，本发明由所附权利要求书限定。因此，我们要求落入这些权利要求范围内的所有这些实施例作为本发明。

Claims (10)

1.一种可植入的假体瓣膜组件，其包括：
可塌缩并且可扩展的框架，其具有多个间隔的支柱，所述多个间隔的支柱从所述框架的第一端延伸至所述框架的第二端并且限定具有最外表面的所述框架的外周界；
假体瓣膜，其通过缝线固定在所述可塌缩并且可扩展的框架内，所述缝线处于所述周界的所述最外表面的内侧。
2.根据权利要求1所述的假体瓣膜组件，其中所述外周界是大体环形的。
3.根据权利要求1-2中任一项所述的假体瓣膜组件，其中所述缝线是线、绳、纤维或金属丝。
4.根据权利要求1-3中任一项所述的假体瓣膜组件，其中所述支柱包括从所述最外表面凹入的多个凹部，并且所述缝线被设置在所述凹部中。
5.根据权利要求4所述的假体瓣膜组件，其中所述多个凹部是圆润的凹陷。
6.根据权利要求4所述的假体瓣膜组件，其中所述多个凹部是成角度的凹陷或多边形的凹陷。
7.根据权利要求4至6中任一项所述的假体瓣膜组件，其中所述多个凹部沿着非均一的所述间隔的支柱和连接所述支柱的节点的横截面的周界。
8.根据权利要求1至7中任一项所述的假体瓣膜组件，其中所述支柱的横截面是圆形的，并且其直径从所述第一端到所述第二端变化。
9.根据权利要求1至7中任一项所述的假体瓣膜组件，其中所述多个间隔的支柱包括金属丝，并且其中所述间隔的支柱的直径从所述第一端到所述第二端变化。
10.根据权利要求4至9中任一项所述的假体瓣膜组件，其中所述多个凹部沿着每个非均一的间隔的支柱均匀地间隔开。
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US11083575B2 (en) 2021-08-10
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