CN110520080B - 假体心脏瓣膜装置及相关联的系统和方法 - Google Patents

假体心脏瓣膜装置及相关联的系统和方法 Download PDF

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CN110520080B
CN110520080B CN201880026018.5A CN201880026018A CN110520080B CN 110520080 B CN110520080 B CN 110520080B CN 201880026018 A CN201880026018 A CN 201880026018A CN 110520080 B CN110520080 B CN 110520080B
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valve
prosthetic heart
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K·米亚西洛
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Turfer 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
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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
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Abstract

本技术是一种假体心脏瓣膜装置以及相关的系统和方法，用于治疗人类心脏的具有天然瓣环和天然瓣叶的天然瓣膜。一种实施例包括具有流入区域和流出区域的瓣膜支承件，以及在瓣膜支承件内的假体瓣膜组件。该装置还包括：锚定构件，该锚定构件具有附连于瓣膜支承件的流出区域的基部；多个臂，该多个臂在部署状态下从基部侧向向外突出并且沿上游方向倾斜；以及固定结构，该固定结构从这些臂向上游延伸。固定结构具有多个支杆，多个支杆限定出环形配合表面，该环状配合表面构造成向外压靠天然瓣环，并且多个固定元件从支杆突出。固定结构的最下游部分在平滑弯曲部处从臂延伸，并且固定结构的最下游部分的固定元件沿上游方向延伸。

Description

假体心脏瓣膜装置及相关联的系统和方法
相关申请的交叉引用
本申请要求2017年4月18日提交的美国专利申请序列号15/490,047的优先权权益，该申请的公开内容在此整体引用作为参考。
技术领域
本技术总体上涉及假体心脏瓣膜装置。本技术的若干个实施例非常适合于经皮的修复和/或置换天然二尖瓣。
背景技术
心脏瓣膜会受到多种病症的影响。例如，二尖瓣会受到二尖瓣反流、二尖瓣脱垂和二尖瓣狭窄的影响。二尖瓣反流是由心脏疾病引起的血液从左心室到左心房的异常泄漏，在这种情况下，二尖瓣的瓣叶无法在峰值收缩压力下合紧成并置。二尖瓣瓣叶可能无法充分合紧，因为心脏疾病通常会导致心肌扩张，在收缩期间，这又使天然二尖瓣瓣环扩大至使瓣叶合不紧的程度。当由于缺血或其它情况导致乳头肌功能受损时，也会发生异常回流。更具体地，随着左心室在收缩期间收缩，受影响的乳头肌不能充分收缩，从而影响瓣叶的正确闭合。
二尖瓣脱垂是二尖瓣瓣叶异常地隆起到左心房中的一种病症。这会引起二尖瓣的不规则行为并导致二尖瓣反流。由于将乳头肌连接至二尖瓣瓣叶下侧的腱(腱索)可能撕裂或拉伸，因此瓣叶可能脱垂而无法合紧。二尖瓣狭窄是二尖瓣口变窄，这种变窄阻碍了左心室舒张时的充盈。
通常使用利尿剂和/或血管扩张剂治疗二尖瓣反流，以减少流回到左心房中的血液量。修复或置换瓣膜的外科手术方法(开放式的和经血管的)也已用于治疗二尖瓣反流。例如，典型的修复技术包括将扩张的瓣环的一些部分箍紧或切除。箍紧例如包括植入通常固定到瓣环或周围组织的环形的或环周的环。其它修复程序将瓣膜瓣叶缝合或夹在一起，使瓣叶彼此部分并置。
或者，更具侵入性的手术通过将机械瓣膜或生物组织植入到心脏中以替代天然二尖瓣来置换整个瓣膜本身。这些侵入性手术通常需要大的开胸手术，因此非常痛苦、发病率高并且需要较长的恢复期。此外，在许多修复和置换手术程序中，装置的耐久性或瓣环成形术环或置换瓣膜尺寸的不正确可能给患者带来其它问题。修复程序还需要高度熟练的心脏外科医师，因为缝线放置不佳或不正确可能会影响程序的成功。
近年来，已经采用了侵入性较小的主动脉瓣置换方法。预先组装的经皮假体瓣膜的示例包括，例如，美敦力/核心瓣膜公司(Medtronic/Corevalve Inc.)(美国加利福尼亚州尔湾市(Irvine))的
Figure GDA0003268364540000021
系统和爱德华兹生命科学公司(EdwardsLifesciences)(美国加利福尼亚州尔湾市)的
Figure GDA0003268364540000022
瓣膜。这两种瓣膜系统均包括可扩张框架和附连于可扩张框架的三叶生物假体瓣膜。主动脉瓣基本上是对称的、圆形的并且具有肌肉环。在主动脉应用场合中，为了匹配天然解剖结构，而且还因为三叶假体瓣膜需要用于假体瓣叶的正确合紧的圆形对称性，可扩张框架在主动脉瓣环处具有对称的圆形形状。因此，主动脉瓣解剖结构使其自身适合于容纳有置换瓣膜的可扩张框架，因为主动脉瓣解剖结构基本上是均匀的、对称的并且肌肉发达。然而，其它心脏瓣膜解剖结构不均匀、不对称或肌肉不发达，因此经血管主动脉瓣置换术可能不适用于其它类型的心脏瓣膜。
发明内容
为解决上述问题，本发明提供一种用于治疗具有天然瓣环和天然瓣叶的人类心脏天然瓣膜的假体心脏瓣膜装置，假体心脏瓣膜装置包括：
瓣膜支承件，瓣膜支承件具有流入区域和流出区域；
假体瓣膜组件，假体瓣膜组件在瓣膜支承件内；以及
锚定构件，锚定构件具有附连于瓣膜支承件的流出区域的基部、在部署状态下从基部侧向向外突出并且沿上游方向倾斜的多个臂、以及从臂向上游延伸的固定结构，固定结构具有多个支杆和多个固定元件，支杆限定出环形配合表面，环形配合表面构造成向外压靠天然瓣环，固定元件从支杆突出，其中，固定结构的最下游部分在平滑弯曲部处从臂延伸，并且所有的固定元件从固定结构的沿上游方向延伸，以及其中臂、支杆和固定元件构造成从封壳部分地部署，且然后通过使封壳和/或装置中的至少一个相对于另一个运动而使得臂、支杆和固定元件滑到封壳中，以重新捕获在封壳内。
附图说明
参照附图可以更好地理解本公开的许多方面。附图中的部件不一定按比例绘制，而是将重点放在清楚地示出本公开的原理上。此外，在图示中仅为了清楚起见，部件在某些视图中可以显示为透明的，而并不表示所示的部件一定是透明的。为了便于参考，在整个本公开内容中，相同的参考标记和/或字母用于标识相似或类似的部件或特征，但是使用相同的参考标记并不意味着部件应被解释为相同。实际上，在本文描述的许多示例中，相同标记的部件是指结构和/或功能不同的不同实施例。本文提供的标题仅是为了方便。
图1是心脏的示意性剖视图，该附图示出了根据本技术的各种实施例的从静脉脉管系统到天然二尖瓣的顺行入路。
图2是心脏的示意性剖视图，该附图示出了根据本技术的各种实施例的通过心房间隔(IAS)的通路，该通路通过将导管放置在导丝上而维持。
图3和图4是心脏的示意性剖视图，这些附图示出了根据本技术的各种实施例的通过主动脉瓣和动脉脉管系统到达天然二尖瓣的逆行入路。
图5是心脏的示意性剖视图，该附图示出了根据本技术的使用经心尖穿孔到达天然二尖瓣的入路。
图6A是剖切侧视图，图6B是俯视图，这些附图示意性地示出了根据本技术的一实施例的假体心脏瓣膜装置。
图7A和7B是示意性地示出了根据本技术的一实施例的递送假体心脏瓣膜装置的各方面的剖切侧视图。
图8是根据本技术的一实施例的假体心脏瓣膜装置的俯视轴测图。
图9A是图8的假体心脏瓣膜装置的侧视图，并且图9B是图9A所示的假体心脏瓣膜装置的一部分的详细视图。
图10是图9A的假体心脏瓣膜装置的仰视轴测图。
图11是根据本技术的一实施例的假体心脏瓣膜装置的侧视图，并且图12A是该假体心脏瓣膜装置的仰视轴测图。
图12B是根据本技术的另一种实施例的假体心脏瓣膜装置的轴测图，并且图12C是图12B所示的心脏瓣膜装置的一部分的详细视图。
图13是图11和图12的假体心脏瓣膜装置相对于递送装置在部分部署状态下的侧视图，图14是该假体心脏瓣膜装置的仰视轴测图。
图15是根据本技术的与假体心脏瓣膜装置一起使用的瓣膜支承件的仰视轴测图。
图16和图17分别是附连于图15的瓣膜支承件的假体心脏瓣膜的侧视图和仰视轴测图。
图18和19是示意性地示出根据本技术的附加实施例的瓣膜支承件的侧视图。
图20是根据本技术的与假体心脏瓣膜装置一起使用的锚定构件的臂单元的示意图。
图21是根据本技术的与假体心脏瓣膜装置一起使用的锚定构件的臂单元的示意图。
图22是根据本技术的图20和21的臂单元的一部分的示意图。
图23是根据本技术的与假体心脏瓣膜装置一起使用的锚定构件的臂单元的示意图。
图24A和24B是示出根据本技术的具有不同的孔眼构造的臂的示意图，该孔眼用于将密封构件联接至锚定构件。
具体实施方式
以下参照图1-19描述该技术的几种实施例的具体细节。尽管以下针对假体瓣膜装置、系统和方法对天然二尖瓣的经皮置换描述了许多实施例，但是除本文所述的这些实施例之外的其它应用和其它实施例也在本技术的范围内。此外，本技术的其它几种实施例可以具有与本文所述不同的构造、部件或程序。因此，本领域普通技术人员将理解的是，该技术可以具有带附加元件的其它实施例，或者该技术可以具有不带有以下参照图1-19示出和描述的多个特征的其它实施例。
关于本说明书中的术语“远侧”和“近侧”，除非另有说明，否则这些术语可以参考假体瓣膜装置和/或相关联的递送装置的部分相对于操作者和/或脉管系统或心脏中的位置的相对位置。例如，在提及适于递送和定位本文所述的各种假体瓣膜装置的递送导管时，“近侧”可以指更靠近装置的操作者的位置或进入脉管系统的切口的位置，并且“远侧”可以指更远离装置的操作者的位置或者沿着脉管系统距切口更远的位置(例如，导管的端部)。关于假体心脏瓣膜装置，术语“近侧”和“远侧”可以指该装置的各部分相对于血流方向的位置。例如，近侧可以指血液流入装置的上游位置或方位(例如，流入区域)，而远侧可以指血液流出装置的下游位置或方位(例如，流出区域)。
总览
本技术的几种实施例涉及如下的二尖瓣置换装置，所述二尖瓣置换装置解决了经皮置换天然二尖瓣的独特挑战，并且非常适合在被部分地部署以重新定位或移除装置之后被重新捕获在经皮递送装置中。与置换主动脉瓣相比，经皮二尖瓣置换面临独特的解剖结构障碍，这使得经皮二尖瓣置换比主动脉瓣置换更具挑战性。首先，与相对对称且均匀的主动脉瓣不同，二尖瓣瓣环呈非圆形的D形或肾形，这种形状具有通常缺乏对称性的非平面、鞍形的几何形状。二尖瓣的复杂且高度可变的解剖结构使得很难设计出良好符合特定患者的天然二尖瓣环的二尖瓣假体。结果，假体可能无法与天然瓣叶和/或瓣环很好地适配，从而可能留下允许血液回流的间隙。例如，将圆柱状瓣膜假体放置在天然二尖瓣中可能在天然瓣膜的连合区域中留下间隙，可能发生穿过该间隙的瓣周漏。
当前所开发的用于经皮主动脉瓣置换术的假体瓣膜不适用于二尖瓣。首先，这些装置中的许多装置需要在接触瓣环和/或瓣叶的支架状结构与假体瓣膜之间进行直接的结构连接。在若干种装置中，支承假体瓣膜的支架柱还接触瓣环或其它周围组织。当心脏收缩时，这些类型的装置将由组织和血液施加的力直接传递至瓣膜支架和假体瓣叶，这又使瓣膜支架从其所期望的圆柱形状变形。这是令人担忧的问题，因为大多数心脏置换装置使用三叶瓣膜，所述三叶瓣膜需要围绕假体瓣膜的基本上对称的圆柱形支承，以在多年的使用寿命中适当地打开和关闭三个瓣叶。结果，当这些装置经受来自瓣环和其它周围组织的运动和力时，假体可能被压缩和/或变形，从而引起假体瓣叶失灵。此外，患病的二尖瓣环比任何可用的假体主动脉瓣大得多。随着瓣膜尺寸的增加，瓣膜瓣叶上的力会急剧增加，因此，简单地将主动脉假体的尺寸增加到扩张的二尖瓣环的尺寸将需要明显更厚、更高的瓣叶，并且可能是不可行的。
除了二尖瓣环的在每次心跳过程中改变尺寸的不规则、复杂的形状之外，二尖瓣环还缺少来自周围组织的大量径向支承。与主动脉瓣完全被纤维弹性组织包围、从而为锚定假体瓣膜提供足够的支承相比，二尖瓣仅由外壁上的肌肉组织约束。二尖瓣解剖结构的内壁由薄的血管壁约束，该薄的血管壁将二尖瓣环与主动脉流出道的下部分开。结果，二尖瓣环上的显著径向力、比如由扩张的支架假体施加的径向力会导致主动脉道的下部塌缩。此外，更大的假体会施加更大的力并扩张至更大的尺寸，这在二尖瓣置换应用场合中加剧了这个问题。
左心室的腱索还可能在部署二尖瓣假体时出现障碍。与主动脉瓣不同，二尖瓣在左心室瓣叶下方有错综复杂的绳索，该绳索在植入期间限制了部署导管和置换装置的运动和位置。结果，在天然二尖瓣环的心室侧上部署、定位和锚定瓣膜置换装置是很复杂的。
本技术的各实施例提供了用于治疗诸如二尖瓣之类的身体心脏瓣膜的系统、方法和设备，其解决了与二尖瓣的解剖结构相关联的挑战，并提供了重新定位和移除部分部署的装置的方法。这些设备和方法能够使用通过静脉或动脉血管内递送到心脏中或通过插入穿过心脏壁的插管递送的导管进行经皮入路。例如，这些设备和方法特别适合于经中隔入路，但也可以是假体置换瓣膜到达心脏中的目标位置的经心尖、经心房和直接主动脉递送。此外，本文所述的装置和方法的各实施例可以与许多已知的手术和程序、比如利用顺行或逆行方法进入心脏瓣膜(例如二尖瓣或三尖瓣)的已知入路路径及其组合相结合。
本文所述的装置和方法提供了一种瓣膜置换装置，该瓣膜置换装置在仅在部分地部署以重新定位和/或移除该装置之后可以被重新捕获在递送装置中。该装置还具有柔性，以适应并符合形状可变的天然二尖瓣解剖结构，同时将假体瓣膜与装置的锚定部分机械隔离。该装置的几种实施例有效地吸收了由天然解剖结构施加的变形力。该装置具有承受心脏随时间变化的动态状况所必需的结构强度和完整性，因此来永久性地固定置换瓣膜。这些装置和方法还以侵入性较小的方式递送这种装置，为患者提供了新的永久性置换瓣膜，并且还具有较低风险的手术程序和更快的康复速度。
进入二尖瓣
为了更好地理解根据本技术的瓣膜置换装置的结构和操作，首先了解用于植入装置的入路是有帮助的。二尖瓣或其它类型的房室瓣可以通过患者的血管以经皮方式进入。经皮是指通过皮肤进入血管的远离心脏的位置，通常使用外科手术切除程序或微创程序、比如通过塞丁格(Seldinger)技术使用针进入。经皮进入远处的脉管系统的能力是众所周知的，并在专利和医学文献中有所描述。根据血管通路的点，到达二尖瓣的通路可以是顺行的，并且可依赖于穿过房间隔到达左心房的进入入路(例如，经中隔方法)。替代地，进入二尖瓣的通路可以是逆行的，在逆行入路中，通过主动脉瓣进入左心室。还可经由经心尖的入路使用插管来实现进入二尖瓣的通路。根据该方法、介入性工具和(一个或多个)支承导管可以多种方式在血管内前进至心脏并且以各种方式与目标心脏瓣膜相邻地定位。
图1示出了用于植入瓣膜置换装置的经中隔入路的阶段。在经中隔入路中，通路经由下腔静脉IVC或上腔静脉SVC，经由右心房RA穿过房间隔IAS穿过，并进入二尖瓣MV上方的左心房LA。如图1所示，具有针2的导管1从下腔静脉IVC运动进入到右心房RA中。一旦导管1到达心房间隔IAS的前侧，针2就前进，使得针2例如在卵圆窝FO或卵圆孔处穿过隔膜进入左心房LA。此时，用导丝置换针2，并抽出导管1。
图2示出了经中隔方法的后续阶段，其中导丝6和引导导管4穿过心房间隔IAS。引导导管4提供进入二尖瓣的通路，以利用该技术植入瓣膜置换装置。
在可替代的顺行入路中(未示出)，可通过肋间切口获得手术通路，优选地不移除肋骨，并在左心房壁中制造小的穿孔或切口。引导导管通过该穿孔或切口直接进入左心房，并通过荷包线缝合来进行密封。
如上所述，对二尖瓣的顺行入路或经房间隔入路在许多方面都是有利的。例如，顺行入路通常将使引导导管和/或假体瓣膜装置能够更精确和有效地定中心和稳定。顺行入路还可减少用导管或其它介入性工具损坏腱索或其它瓣下结构的风险。此外，与在逆行入路中一样，顺行入路可降低与穿过主动脉瓣相关联的风险。这对于具有如下的假体主动脉瓣的患者尤其重要，该假体主动脉瓣不能完全穿过或没有实质性的损伤风险。
图3和图4示出了进入二尖瓣的逆行入路的各示例。可以从主动脉弓AA、穿过主动脉瓣AV并进入二尖瓣MV下方的左心室LV来实现进入二尖瓣MV。主动脉弓AA可通过常规的股动脉通路路线或经由肱动脉、腋动脉、桡动脉或颈动脉通过更直接的方法进入。这种通路可通过使用导丝6来实现。一旦就位，就可使引导导管4在导丝6上跟踪行进。替代地，可通过在胸腔中的切口采取外科手术入路，从而优选地在不移除肋骨的情况下进行肋间手术，并且通过穿孔将引导导管放置在主动脉自身中。引导导管4具备后续通路以允许放置假体瓣膜装置，如本文中更详细描述的。逆行入路有利地不需要经中隔穿孔。心脏科医生也更常使用逆行入路，因此逆行入路更为熟悉。
图5示出了经由经心尖穿刺的经心尖入路。在这种入路中，经由胸腔切口进入心脏，该胸腔切口可以是传统的开胸手术或胸骨切开术，或较小的肋间或下肾旁切口或穿孔。然后将通路插管通过穿孔放置在心脏的心尖处或附近的左心室壁中。然后可通过该通路插管将本发明的导管和假体装置引入左心室。经心尖入路为二尖瓣或主动脉瓣提供了更短、更直、更直接的路径。进一步地，因为它不涉及血管内通路，所以经心尖入路不需要进行介入性心脏病学方面的培训来执行其它经皮入路所需的导管插入术。
假体心脏瓣膜装置和方法的选定实施例
本技术的各实施例可以治疗心脏的一个或多个瓣膜，并且具体地，几种实施例有利地治疗二尖瓣。本技术的假体瓣膜装置还可以适合于置换患者心脏中的其它瓣膜(例如，二尖瓣或三尖瓣)。在本部分中参照图6A-19描述了根据本技术的各实施例的假体心脏瓣膜装置、系统部件和相关联的方法的各示例。参照图6A-19描述的各实施例的具体元件、子结构、优点、用途和/或其它特征可以适当地互换、替换或以其它方式构造。此外，参照图6A-19描述的各实施例的合适元件可以用作独立和/或自包含的装置。
图6A是根据本技术的一实施例的假体心脏瓣膜装置(“装置”)100的侧视剖视面图，图6B是该装置的俯视图。装置100包括瓣膜支承件110、附连于瓣膜支承件110的锚定构件120以及瓣膜支承件110内的假体瓣膜组件150。参照图6A，瓣膜支承件110具有流入区域112和流出区域114。假体瓣膜组件150布置在瓣膜支承件110内，以允许血液从流入区域112流过流出区域114(箭头BF)，但是防止血液沿从流出区域114通过流入区域112的方向流动。
在图6A所示的实施例中，锚定构件120包括附连于瓣膜支承件110的流出区域114的基部122以及从基部122侧向向外突出的多个臂124。锚定构件120还包括从臂124延伸的固定结构130。固定结构130可以包括第一部分132和第二部分134。固定结构130的第一部分132例如可以是固定结构130的上游区域，其在如图6A所示的部署构造中与瓣膜支承件110的流入区域112侧向地向外间隔开间隙G。固定结构130的第二部分134可以是固定结构130的最下游部分。固定结构130可以是圆柱环(例如，直圆柱或圆锥形)，并且固定结构130的外表面可以限定有环形配合表面，该环形配合表面构造成向外压靠天然瓣环。固定结构130还可以包括多个固定元件136，这些固定元件136径向向外突出并且朝向上游方向倾斜。固定元件136例如可以是倒钩、钩子或仅沿上游方向(例如，远离装置100的下游部分延伸的方向)倾斜的其它元件。
仍然参照图6A，锚定构件120在臂124与固定结构130之间具有平滑弯曲部140。例如，固定结构130的第二部分134在平滑弯曲部140处从臂124延伸。臂124和固定结构130可以由连续的支杆或支承元件一体地形成，使得平滑弯曲部140是连续的支杆的弯曲部分。在其它实施例中，平滑弯曲部140可以是相对于臂124或固定结构130的单独部件。例如，可以使用形成平滑连接部的焊缝、粘合剂或其它技术将平滑弯曲部140附连于臂124和/或固定结构130。平滑弯曲部140构造成，使得在装置100已经至少部分地部署之后，装置100可以被重新捕获在封壳或其它容器中。
装置100还可以包括在瓣膜支承件110上的第一密封构件162和在锚定构件120上的第二密封构件164。第一密封构件162和第二密封构件164可以由柔性材料制成，比如
Figure GDA0003268364540000101
或其它类型的聚合材料。第一密封构件162可以覆盖瓣膜支承件110的内表面和/或外表面。在图6A所示的实施例中，第一密封构件162附连于瓣膜支承件110的内表面，并且假体瓣膜组件150附连于第一密封构件162和瓣膜支承件110的连合部分。第二密封构件164附连于锚定构件120的内表面。结果，固定结构130的外部环形配合表面没有被第二密封构件164覆盖，使得固定结构130的外部环形配合表面直接接触天然瓣环的组织。
装置100还可以包括延伸构件170。延伸构件170可以是第二密封构件164的延伸，或者可以是附连于第二密封构件164和/或固定结构130的第一部分132的单独的部件。延伸构件170可以是柔性构件，其在如图6A所示的部署状态下相对于固定结构130的第一部分132挠曲。在操作中，延伸构件170提供触觉反馈或视觉指示(例如，在超声心动图或荧光成像系统上)，以在植入期间引导装置100，使得装置位于期望的高度处并且相对于天然瓣环居中。如下所述，延伸构件170可以包括能够在植入期间可见的支承构件，比如金属丝或其它结构。例如，支承构件可以是不透射线的丝线。
图7A和图7B是示出在部分部署之后于重新捕获装置100中在臂124与固定结构130之间的平滑弯曲部140的操作的示例的剖视图。图7A示意性地示出了被装载到递送系统的封壳700中的处于递送状态的装置100，并且图7B示意性地示出了处于部分部署状态的装置100。参照图7A，封壳700具有壳体702、支承件704和顶部706。在图7A所示的递送状态下，装置100处于低轮廓构造，其适于通过导管或插管递送至天然心脏瓣膜处的目标植入部位。
参照图7B，封壳700的壳体702已经向远侧运动，使得延伸构件170、固定结构130和臂124的一部分已经以部分部署的状态从壳体702释放。这对于将固定结构130相对于天然瓣环A定位在适当的高度处是有用的，使得固定结构130径向向外扩张并接触天然瓣环A的内表面。然而，装置100在被部分部署之后可能需要重新定位和/或从患者移除。为此，使壳体702朝固定结构130缩回(箭头R)。随着壳体702沿着臂124滑动，臂124与固定结构130之间的平滑弯曲部140允许壳体702的边缘708在平滑弯曲部140上滑动，并由此将固定结构130和延伸构件170重新捕获在壳体702内。然后，可以将装置100从患者体内移除或者相对于天然瓣环A重新部署在更好的位置处。以下参照图8-19描述根据本技术的假体心脏瓣膜装置的另外的方面及其与对应的递送装置的相互作用。
图8是装置100的示例的俯视轴测图。在该实施例中，瓣膜支承件110限定有第一框架(例如，内部框架)，并且锚定构件120的固定结构130限定有第二框架(例如，外部框架)，第一框架和第二框架每个包括多个结构元件。更具体地，固定结构130包括布置在菱形单元格138中的结构元件137，当如图8所示地自由且完全扩张时，这些结构元件137一起形成至少基本上圆柱形的环。结构元件137可以是由金属、聚合物、或者可以自扩张或者通过球囊或其它类型的机械扩张件来扩张的其它合适的材料形成的支杆或其它结构特征。
固定结构130的几种实施例可以是具有面向外的配合表面的大致圆柱形的固定环。例如，在图8所示的实施例中，结构元件137的外表面限定有环形配合表面，该环形配合表面构造成在部署状态下向外压靠天然瓣环。在没有任何限制的完全扩张状态下，固定结构130至少基本上平行于瓣膜支承件110。然而，当固定结构130径向向外压靠心脏瓣膜的天然瓣膜的内表面时，固定结构130可以在部署状态下向内挠曲(箭头I)。
图8所示的装置100的实施例包括内衬于瓣膜支承件110的内表面的第一密封构件162以及沿着固定结构130的内表面的第二密封构件164。延伸构件170具有柔性幅材172(例如，织物)和附连于柔性幅材172的支承构件174(例如，金属或聚合物股线)。柔性幅材172可以从第二密封构件164延伸，而在固定结构130与支承构件174之间没有金属对金属的连接。例如，延伸构件170可以是第二密封构件164的材料的延续。因此，延伸构件170的几种实施例是可以相对于固定结构130容易挠曲的柔软结构。支承构件174可以具有多种构造，并且可以由多种材料制成，比如由镍钛诺制成的双蛇形结构。
图9A是图8所示的装置100的侧视图，图9B是图9A的一部分的详细视图，而图10是该装置100的仰视轴测图。参照图9A，臂124从基部122以一定角度α径向向外延伸，该角度α选择成在部署状态下将固定结构130径向向外地离开瓣膜支承件110(图8)一段期望的距离地定位。角度α还选择成允许壳体702的边缘708(图7B)在重新捕获期间从基部122朝向固定结构130滑动。在许多实施例中，角度α为15°-75°、或更具体地为15°-60°、或更具体地为30°-45°。固定结构130的臂124和结构元件137可以由相同的支杆形成(即，彼此一体地形成)，使得平滑弯曲部140是从臂124到结构元件137的连续的、平滑的过渡部。预期这将使得壳体702的边缘708能够以允许将固定结构130重新捕获在封壳700的壳体702中的方式更容易地在平滑弯曲部140上滑动(图7B)。此外，与其中臂124和结构元件137是分开的部件并且彼此焊接或以其它方式紧固的构造相比，通过将臂124和结构元件137彼此一体地形成减少了在臂124与结构元件137之间的接合部处破坏装置100的可能性。图9A和9B还示出了装置100还可以在流出区域处包括V形支承支杆，这些支杆在锚定构件120的底部122的臂124之间延伸。基部122处的V形支承件并不必须具有“平滑弯曲部”、比如在从臂124到固定结构130的最下游部分的过渡部处的平滑弯曲部140。由此，只要装置100的V形支承件和其它元件朝向流入区域突出以允许重新捕获，装置100的某些部分、具体地是锚定构件120就不需要具有这种平滑弯曲部。
参照图9B和图10，臂124布置在V形臂单元125中，每个V形臂单元具有在基部122处从分叉127延伸的一对臂124。在该实施例中，每个V形臂单元125中的各个臂124沿着它们的整个长度彼此分开，该整个长度是从它们连接于基部部分122的地方通过平滑弯曲部140(图9A)到固定结构130的结构元件137。因此，当在重新捕获期间壳体702的边缘708(图7B)沿着臂124滑动时，各个臂124能够容易地挠曲。预期这将减少壳体702的边缘708卡在臂124上的可能性，并防止装置100重新捕获在壳体702中。
在一种实施例中，臂124具有从基部122到平滑弯曲部140的第一长度，并且固定结构130在单元格138(图8)的每一侧处的结构元件137具有第二长度。结构元件137的沿着单元格138的每一侧的第二长度小于臂124的第一长度。固定结构130因此不如臂124柔性。结果，固定结构130能够以足够的力向外压靠天然瓣环，以将装置100固定至天然瓣环，而臂124具有足够的柔性，以当装置被重新捕获在递送装置中时向内折叠。
在图8-10所示的实施例中，臂124和结构元件137构造成，使得每个臂124和从每个臂124延伸的两个结构元件137形成锚定构件120的Y形部分142(图10)。此外，每个Y形部分142的右侧结构元件137直接联接于紧邻的Y形部分142的左侧结构元件137。预期在重新捕获期间，Y形部分142和平滑弯曲部140进一步提高使壳体702沿着臂124和固定结构130滑动的能力。
图11是根据本技术的另一种实施例的假体心脏瓣膜装置(“装置”)200的侧视图，并且图12A是该假体心脏瓣膜装置200的仰视轴测图。装置200被示出为不具有延伸构件170(图8-10)，但是装置200可以另外地包括上述延伸构件170。与图10所示的装置100的基部122处的双排V形支承件相反，图12A中示出的装置200的基部122还包括仅单排的V形支承件216。装置200还包括从锚定构件120的基部122突出的延伸连接部210。或者，作为从锚定构件120的基部122延伸的附加或替代，延伸连接部210可以从瓣膜支承件110(图6A-10)延伸。延伸连接部210可以包括附连于基部122的一部分的第一支杆212a和附连于基部122的另一部分的第二支杆212b。第一支杆212a和第二支杆212b构造成形成V形结构，在该结构中它们沿下游方向朝向彼此延伸，并且在V形结构的底部处彼此相连接。当装置200在递送期间或部分部署期间在封壳700(图7A)内处于低轮廓构造时，第一支杆212a和第二支杆212b的V形结构使延伸连接部210伸长。当装置200从封壳700完全释放时(图7A)，延伸连接部210缩短，以避免干扰沿左心室流出道的血液流动。
延伸连接部210还包括构造成可释放地配合递送装置的附连元件214。该附连元件214可以是T形杆或其它元件，其防止装置200从递送装置的封壳700(图7A)释放，直到期望这么做为止。例如，T形杆型附连元件214可以防止装置200在部署或部分部署期间轴向运动，直到壳体702(图7A)向远侧运动超过附连元件214，使得瓣膜支承件110的流出区域和锚定构件120的底部122可以在完全部署时完全扩张。
图12B是根据本技术的另一种实施例的假体心脏瓣膜装置200a(“装置200a”)的轴测图，并且图12C是装置200a的臂单元的详细视图。装置200a基本上类似于图12A中所示的装置200，但是装置200a包括多个Y形臂单元224而不是V形臂单元。参照图12C，臂单元224具有主干226和在分叉227处从主干226延伸的两个臂228。每个Y形臂单元224的主干226从锚定构件120的基部122的单排V形支承件216延伸，并且主干226的长度使得分叉227的位置与基部122相距一定距离。Y形臂单元224的臂228可以稍短于以上参照图9B描述的V形臂单元125的臂124，但是Y形臂和V形臂单元的总长度224和125可以大致相同。与V形臂单元125相比，Y形臂单元224减少了V形支承件216的区域中的金属量，这减少了锚定构件120的基部122处的材料，使得装置200a可以褶缩成较小的直径以进行递送。此外，Y形臂单元224还具有足够的柔性，使得装置200a可以被重新套进递送装置的封壳中。图13是处于部分部署状态的装置200的侧视图，图14是装置200的仰视轴测图，其中装置200仍然能够被重新捕获在递送装置700的壳体702中。参照图13，装置200部分地部署，其中固定结构130基本上扩张，但是附连元件214(图11)仍然保持在封壳700内。这对于确定装置200的位置的准确性以及允许血液在植入期间流过功能性置换瓣膜是有用的，同时在需要将装置200重新定位或从患者体内移除的情况下保持重新捕获装置200的能力。在该部分部署状态下，延伸连接部210的伸长的第一支杆212a和第二支杆212b使锚定构件120的基部122和瓣膜支承件110(图6A)的流出区域与封壳702的边缘708间隔开间隙G。
参照图14，在装置200仅部分地部署的同时，间隙G使血液能够流过假体瓣膜组件150。结果，装置200可以部分地部署以确定：(a)装置200是否相对于天然心脏瓣膜解剖结构正确地定位，以及(b)在装置200仍被递送系统700保持时，是否有适当的血液流过假体瓣膜组件150。由此，如果装置200不在所期望的位置中和/或如果假体瓣膜不能正常运作，则可以重新捕获装置200。预期该附加功能将显著增强正确放置装置200并在体内评估装置200是否按预期运行的能力，同时保持重新定位装置200以在患者体内重新部署装置或从患者体内移除装置200的能力。
图15是根据本技术的一实施例的瓣膜支承件300的仰视轴测图。瓣膜支承件300可以是以上参照图6A-14描述的瓣膜支承件110的实施例。瓣膜支承件300具有流出区域302、流入区域304、在流出区域302处的第一六边形单元格312的第一排310以及在流入区域304处的第二六边形单元格322的第二排320。出于说明的目的，图15中所示的瓣膜支承件与图6A-14中所示的瓣膜支承件100相比是倒置的，使得血液沿箭头BF的方向流过瓣膜支承件300。在二尖瓣应用场合中，瓣膜支承件300将会定位在锚定构件120内(图6A)，使得流入区域304将会对应于图6A中流入区域112的定向，并且流出区域302将会对应于图6A中的流出区域114的定向。
每个第一六边形单元格312包括一对第一纵向支承部314、下游顶点315和上游顶点316。每个第二六边形单元格322可以包括一对第二纵向支承部324、下游顶点325和上游顶点326。第一六边形单元格312和第二六边形单元格322的第一排310和第二排320彼此直接相邻。在所示的实施例中，第一纵向支承部314直接从第二六边形单元格322的下游顶点325延伸，并且第二纵向支承部324直接从第一六边形单元格312的上游顶点316延伸。结果，第一六边形单元格312绕瓣膜支承件300的周缘从第二六边形单元格322周向地偏移单元格宽度的一半。
在图15所示的实施例中，瓣膜支承件300包括在流出区域302处的多个第一支杆331、在流入区域304处的多个第二支杆332以及多个第三支杆333。每个第一支杆331从第一纵向支承部314的下游端延伸，并且成对的第一支杆331连接在一起以形成第一下游V形支杆，该第一下游V形支杆限定出第一六边形单元格312的下游顶点315。在相关意义上讲，每个第二支杆332从第二纵向支承部324的上游端延伸，并且成对的第二支杆332连接在一起以形成第二上游V形支杆，该第二上游V形支杆限定出第二六边形单元格322的上游顶点326。第三支杆333中的每一个具有连接于第一纵向支承部314的上游端的下游端，并且第三支杆333中的每一个具有连接于第二纵向支承部324之一的下游端的上游端。因此，第三支杆333的下游端限定出形成第二六边形单元格322的下游顶点325的第二下游V形支杆布置，并且第三支杆333的上游端限定出形成第一六边形单元格312的上游顶点316的第一上游V形支杆布置。因此，第三支杆333既限定出第一六边形单元格312的第一上游V形支杆，又限定出第二六边形单元格322的第二下游V形支杆。
第一纵向支承部314可以包括多个孔336，缝线可以穿过这些孔336以附连假体瓣膜组件和/或密封构件。在图15所示的实施例中，仅第一纵向支承部314具有孔336。但是，在其它实施例中，作为对第一纵向支承部314中的孔336的附加或替代情形，第二纵向支承部324也可以包括孔。
图16是瓣膜支承件300的侧视图，图17是瓣膜支承件300的仰视轴测图，其中第一密封构件162附连于瓣膜支承件300，并且假体瓣膜150位于瓣膜支承件300内。第一密封构件162可以通过联接于第一纵向支承部314和第二纵向支承部324的多个缝线360附连于瓣膜支承件300。联接于第一纵向支承部314的缝线360中的至少一些穿过孔336，以将第一密封构件162进一步固定至瓣膜支承件300。如果孔336是作为第一纵向支承部314的孔336的附加或替代而被包括，则缝线360也可以穿过孔336。
参照图17，假体瓣膜150可以附连于瓣膜支承件300的第一密封构件162和/或第一纵向支承部314。例如，假体瓣膜150的连合部分可以与第一纵向支承部314对准，并且缝线360可以穿过假体瓣膜150的连合部分和第一密封构件162，其中假体瓣膜150的连合部分与第一纵向支承部314对准。假体瓣膜150的流入部分可以被缝合至第一密封构件162。
预期图15-17中所示的瓣膜支承件300非常适合与装置100和200一起使用，并且分别在上面参照图8-10和11-14进行了描述。更具体地，第一支杆331与锚定构件122的基部协作。与瓣膜支承件完全扩张时相比，第一支杆331例如在瓣膜支承件300没有完全扩张时伸长。除了支杆的伸长之外，假体瓣膜150在瓣膜支承件300内的位置还允许假体瓣膜150的流出部分在部分部署的状态下与封壳700进一步间隔开，使得假体瓣膜150可以在部分部署状态下至少部分地运作。或者，如果附连于装置200，则当装置200处于部分部署状态时，装置200的延伸连接部210(图11至图14)用于将假体瓣膜150的流出部分与封壳700(图13-14)进一步分离，从而允许假体瓣膜150的部分功能。在完全部署后，第一支杆331缩短。因此，预期瓣膜支承件300增强了评估假体瓣膜150是否在部分部署状态下是完全可操作的能力。预期该附加功能将显著增强在体内评估装置100和200是否将按预期运行的能力，同时保持重新定位装置100和200以在患者体内重新部署装置或从患者体内移除装置100和200的能力。
图18和19分别是根据本技术的实施例的瓣膜支承件400和500的示意性侧视图。瓣膜支承件400包括第一六边形单元格412的第一排410和第二六边形单元格422的第二排420。瓣膜400还可以包括从第一六边形单元格412延伸的第一排菱形单元格430以及从第二六边形单元格422延伸的第二排菱形单元格440。附加的菱形单元格在低轮廓状态下伸长，因此它们可以将假体瓣膜150(示意性地示出)与递送装置的封壳进一步间隔开，从而增强了在体内评估装置是否将按预期运行的能力，同时保持了将装置重新定位或从患者体内移除的能力。参照图19，瓣膜支承件500包括在流出区域502处的第一六边形单元格512的第一排510和在流入区域504处的第二六边形单元格522的第二排520。瓣膜支承件500成形为，使得中间区域506的横截面面积小于流出区域502和/或流入区域504的横截面面积。由此，第一六边形单元格512的第一排510沿下游方向向外扩口，并且第二六边形单元格522的第二排520沿上游方向向外扩口。预期扩口的流出区域502和流入区域504将改善通过瓣膜支承件500的血流。此外，与平直的圆柱形设计相比，扩口的流出区域502和流入区域504减小了瓣膜支承件的长度，这减少了瓣膜支承件500延伸到左心室中的量。
图20是示出根据本技术的一实施例的锚定构件120的一部分的示意图。在该实施例中，锚定构件120包括固定结构130和V形臂单元620(仅示出了单个臂单元)。每个V形臂单元620包括从基部122延伸到固定结构130的一对臂622(仅示出了一部分)，并且每个臂622包括具有第一柔性的第一部分624和具有第二柔性的第二部分626，第二柔性小于第一柔性。臂622的第一部分624在锚定构件120的基部122处选择性地具有柔性，而臂622的第二部分626具有足够的刚度以径向向外推动固定结构130，用于配合天然瓣环。在所示的实施例中，臂622的第一部分624是蛇形构件(例如，相应的连接器)，并且臂622的第二部分626相比第一部分624更平直。例如，臂622的第二部分626可沿着弧形部(例如，单个弧)径向向外弯曲，这与第一部分624的蛇形或锯齿形构造相反。
图21是示出根据本技术的实施例的另一种锚定构件120的一部分的示意图，该锚定构件120包括Y形臂单元720(仅示出了单个臂单元720)。每个Y形臂单元720具有主干724以及从主干724延伸的臂726。主干724具有第一柔性，并且臂726具有小于第一柔性的第二柔性。例如，主干724是具有蛇形构造的支杆(例如，手风琴状(accordion)的连接部)，并且臂726可以是弯曲的支杆，其以扩张构造从主干724径向向外延伸。
图22示意性地示出了图20和21中所示的臂单元620和720的操作。在操作中，天然瓣环(未示出)抵靠固定结构130而施加压缩瓣环力FA，同时该收缩压产生力FP。第一部分624或主干724的附加柔性允许臂单元620和720优先地在瓣膜支承件110的流出端附近挠曲，以允许固定结构130通过天然瓣环变形，同时减轻了在基部122处抵靠瓣膜支承件110而施加的连合力FC。值得注意的是，臂622的第二部分626和臂726具有足够的刚度，以向天然瓣环提供期望的径向向外的力，以将假体心脏瓣膜装置固定在天然心脏瓣膜处。
图23示出了根据本技术的另一种实施例的支承固定结构130的臂800。臂800可以包括构造成联接于瓣膜支承件的流出区域的第一部分820以及从第一部分820延伸至固定结构130的第二部分822。臂800的第一部分820可以对应于V形臂单元620的臂622的第一部分或Y形臂单元720的主干724的第一部分。臂800的第一部分820还可以包括多个向外的凹部824(例如，槽口)，这些凹部824使得第一部分822能够优先向外挠曲(箭头O)。预期臂800的性能基本上类似于以上参照图20-22所描述的臂622和Y形臂单元720。
图24A和24B是示出了臂124的示意图，臂124的孔眼900具有不同的构造，以用于将第二密封构件164(图6A和6B)联接至锚定构件120。参照图24A，孔眼900在臂124的外部。参照图24B，这些孔眼在臂124的内部。在两种实施例中，缝线902穿过孔眼以将第二密封构件164附连至锚定构件120的内部。图24B所示的实施例具体地适合于重新套住假体心脏瓣膜装置，因为孔眼的形状设定为向内延伸，以消除或以其它方式限制相对于臂124外表面的突出，该突出会抑制封壳在重新套住期间在臂124上滑动。
示例
在以下示例中实施了上述本技术的几个方面。
1.一种用于治疗具有天然瓣环和天然瓣叶的人类心脏天然瓣膜的假体心脏瓣膜装置，包括：
瓣膜支承件，所述瓣膜支承件具有流入区域和流出区域；
假体瓣膜组件，所述假体瓣膜组件在所述瓣膜支承件内；以及
锚定构件，所述锚定构件具有附连于所述瓣膜支承件的所述流出区域的基部、在部署状态下从所述基部侧向向外突出并且沿上游方向倾斜的多个臂、以及从所述臂向上游延伸的固定结构，所述固定结构具有多个支杆和多个固定元件，所述支杆限定出环形配合表面，所述环形配合表面构造成向外压靠天然瓣环，所述固定元件从所述支杆突出，其中，所述固定结构的最下游部分在平滑弯曲部处从所述臂延伸，并且所述固定元件在所述固定结构的所述最下游部分处沿上游方向延伸。
2.如示例1所述的假体心脏瓣膜装置，其中，所述臂在其整个长度上彼此间隔开。
3.如示例1-2中任一项所述的假体心脏瓣膜装置，其中，所述固定结构的所述支杆布置在具有侧面的单元格中，并且所述臂具有第一长度，并且所述单元格的每一侧具有小于所述第一长度的第二长度。
4.如示例1-3中任一项所述的假体心脏瓣膜装置，其中，每个所述臂以及所述固定结构的从每个所述臂延伸的所述支杆形成所述锚定构件的Y形部分，并且每个所述Y形部分的右侧支杆直接联接于紧邻的所述Y形部分的左侧支杆。
5.如示例1-4中任一项所述的假体心脏瓣膜装置，还包括从所述瓣膜支承件的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述瓣膜支承件和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
6.如示例1-5中的任一项所述的假体心脏瓣膜装置，其中，从所述固定结构突出的所有所述固定元件都沿上游方向延伸。
7.如示例1-6中任一项所述的假体心脏瓣膜装置，其中，所述瓣膜支承件包括：
第一排第一六边形单元格，所述第一排第一六边形单元格在所述瓣膜支承件的所述流出区域处，并且所述第一六边形单元格具有第一纵向支承部；
第二排第二六边形单元格，所述第二排第二六边形单元格在所述瓣膜支承件的所述流入区域，所述第二六边形单元格具有第二纵向支承部，其中，所述第一六边形单元格和所述第二六边形单元格彼此直接相邻，使得所述第一纵向支承部直接从所述第二六边形单元格的下游顶点延伸，且所述第二纵向支承部直接从所述第一六边形单元格的上游顶点延伸；以及
其中，所述假体瓣膜组件附连于所述第一纵向支承部中的至少一个和/或所述第二纵向支承部中的至少一个。
8.如示例7所述的假体心脏瓣膜装置，其中，所述瓣膜支承件还包括在所述第一排六边形单元格的下游端处的第一排菱形单元格和在所述第二排六边形单元格的上游端处的第二排菱形单元格。
9.如示例7所述的假体心脏瓣膜装置，其中，所述第一排六边形单元格沿所述下游方向向外扩口，并且所述第二排六边形单元格沿所述上游方向向外扩口。
10.如示例7所述的假体心脏瓣膜装置，还包括从所述瓣膜支承件的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述瓣膜支承件和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
11.如示例1-10中的任一项所述的假体心脏瓣膜装置，其中，所述瓣膜支承件包括：
第一排的第一六边形单元格，所述第一排的第一六边形单元格在所述瓣膜支承件的所述流出区域处，其中，所述第一六边形单元格具有：第一纵向支承部、从所述第一纵向支承部向上游延伸的第一上游V形支杆、以及从所述第一纵向支承部向下游延伸的第一下游V形支杆；
第二排的第二六边形单元格，所述第二排的第二六边形单元格在所述瓣膜支承件的所述流入区域处，其中，所述第二六边形单元格具有：第二纵向支承部、从所述第二纵向支承部向上游延伸的第二上游V形支杆、以及从所述第二纵向支承部向下游延伸的第二下游V形支杆；以及
其中，所述第一六边形单元格的所述第一上游V形支杆与所述第二六边形单元格的所述第二下游V形支杆为同一支杆。
12.一种用于治疗具有天然瓣环和天然瓣叶的人类心脏天然瓣膜的假体心脏瓣膜装置，包括：
环形内部支承框架，所述环形内部支承框架具有流入区域和流出区域；
假体瓣膜组件，所述假体瓣膜组件在所述内部支承框架内；以及
锚定构件，所述锚定构件具有：附连于所述内部支承框架的所述流出区域的基部、以沿上游方向倾斜的角度从基部侧向向外突出的多个臂、以及从所述臂向上游延伸的外部固定框架，所述外部固定框架具有多个支杆，所述多个支杆限定出环形配合表面，所述环形配合表面在部署状态下与所述内部支承框架的所述流入区域径向向外地间隔开，其中，所述臂和所述支杆构造成从封壳中部分地部署，然后通过使所述封壳和/或装置中的至少一个相对于另一个运动而使得所述臂和所述支杆滑到所述封壳中，以至少基本上被重新捕获在所述封壳内。
13.如示例12所述的假体心脏瓣膜装置，其中，所述臂在其整个长度上彼此间隔开。
14.如示例12-13中任一项所述的假体心脏瓣膜装置，其中，所述外部固定框架的所述支杆布置在具有侧面的单元格中，并且所述臂具有第一长度，并且所述单元格的每一侧具有小于所述第一长度的第二长度。
15.如示例12-14中任一项所述的假体心脏瓣膜装置，其中，每个所述臂以及所述外部固定框架的从每个所述臂延伸的所述支杆形成所述锚定构件的Y形部分，并且每个所述Y形部分的右侧支杆直接联接于紧邻的所述Y形部分的左侧支杆。
16.如示例12-15中任一项所述的假体心脏瓣膜装置，还包括从所述内部环形支承框架的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述内部环形支承框架和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
17.如示例12-16中任一项所述的假体心脏瓣膜装置，还包括从所述外部固定框架突出的固定元件，并且其中，从所述外部固定框架突出的所有所述固定元沿上游方向延伸。
18.如示例12-17中的任一项所述的假体心脏瓣膜装置，其中，所述内部环形支承框架包括：
第一排的第一六边形单元格，所述第一排的第一六边形单元格在所述内部环形支承框架的所述流出区域处，并且所述第一六边形单元格具有第一纵向支承部；
第二排的第二六边形单元格，所述第二排的第二六边形单元格在所述内部环形支承框架的所述流入区域处，所述第二六边形单元格具有第二纵向支承部，其中，所述第一六边形单元格和所述第二六边形单元格彼此直接相邻，使得所述第一纵向支承部直接从所述第二六边形单元格的下游顶点延伸，且所述第二纵向支承部直接从所述第一六边形单元格的上游顶点延伸；以及
其中，所述假体瓣膜组件附连于所述第一纵向支承部中的至少一个和/或所述第二纵向支承部中的至少一个。
19.如示例18所述的假体心脏瓣膜装置，其中，所述内部环形支承框架还包括在所述第一排六边形单元格的下游端处的第一排菱形单元格和在所述第二排六边形单元格的上游端处的第二排菱形单元格。
20.如示例18所述的假体心脏瓣膜装置，其中，所述第一排六边形单元格沿所述下游方向向外扩口，并且所述第二排六边形单元格沿所述上游方向向外扩口。
21.如示例18所述的假体心脏瓣膜装置，还包括从所述内部环形支承框架的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述内部环形支承框架和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
22.如示例1-21中任一项所述的假体心脏瓣膜装置，其中，所述臂成对地布置以限定出V形臂单元。
23.如示例22所述的假体心脏瓣膜装置，其中，所述V形臂单元具有一对臂，并且每个所述臂具有第一部分和第二部分，所述第一部分具有第一柔性，所述第二部分具有小于所述第一柔性的第二柔性。
24.如示例23所述的假体心脏瓣膜装置，其中，所述第一部分具有蛇形构造。
25.如示例23所述的假体心脏瓣膜装置，其中，所述第一部分具有向外开口的槽口。
26.如示例1、3-12和14-21中的任一项所述的假体心脏瓣膜装置，其中，所述臂布置在Y形臂单元中，所述Y形臂单元具有主干和从所述主干延伸的一对臂。
27.如示例26所述的假体心脏瓣膜装置，其中，所述主干具有第一柔性，并且所述臂具有小于第一柔性的第二柔性。
28.如示例27所述的假体心脏瓣膜装置，其中，所述主干具有蛇形构造。
29.如示例27所述的假体心脏瓣膜装置，其中，所述主干具有向外开口的多个槽口。
30.一种部署假体心脏瓣膜装置以治疗天然心脏瓣膜的方法，所述方法包括：
从递送装置的封壳部分地部署假体心脏瓣膜装置，使得瓣膜支承件的流入区域和固定结构的流入区域相对于所述封壳径向向外扩张，而所述固定结构的所述流入区域在所述瓣膜支承件的外部径向间隔开，其中，所述瓣膜支承件和/或所述固定结构的流出区域保持在所述封壳内，并且其中，在所述瓣膜支承件内的假体瓣膜的下游端与所述封壳的远端之间存在间隙，使得当所述流出区域在所述封壳内时流体可以流过所述瓣膜；以及
将所述假体心脏瓣膜装置重新捕获在所述封壳内。
31.如示例30所述的方法，其中，所述天然心脏瓣膜是天然二尖瓣。
32.如示例30所述的方法，其中，所述天然心脏瓣膜是天然主动脉瓣。
33.一种用于假体心脏瓣膜的瓣膜支承件，所述瓣膜支承件包括：
第一排的第一六边形单元格，所述第一排的第一六边形单元格在所述瓣膜支承件的流出区域处，其中，所述第一六边形单元格具有：第一纵向支承部、从所述第一纵向支承部向上游延伸的第一上游支杆和第二上游支杆、以及从所述第一纵向支承部向下游延伸的第一下游支杆和第二下游支杆；
第二排的第二六边形单元格，所述第二排的第二六边形单元格在所述瓣膜支承件的流出区域处，其中，所述第二六边形单元格具有：第二纵向支承部、从所述第二纵向支承部向上游延伸的第一上游支杆和第二上游支杆、以及从所述第二纵向支承部向下游延伸的第一下游支杆和第二下游支杆；以及
其中，所述第一六边形单元格的所述第一上游支杆和所述第二上游支杆与所述第二六边形单元格的所述第一下游支杆和所述第二下游支杆为相同的支杆。
34.如示例33所述的瓣膜支承件，其中，所述第一纵向支承部和所述第二纵向支承部具有第一宽度，并且所述第一上游支杆和所述第二上游支杆以及所述第一下游支杆和所述第二下游支杆的第二宽度小于所述第一宽度。
35.如示例33-34中任一项所述的瓣膜支承件，其中：
所述第一六边形单元格和所述第二六边形单元格彼此直接相邻，使得所述第一纵向支承部直接从所述第二六边形单元格的下游顶点延伸，并且所述第二纵向支承部直接从所述第一六边形单元格的上游顶点延伸；以及
其中，所述假体瓣膜组件附连于所述第一纵向支承部中的至少一个和/或所述第二纵向支承部中的至少一个。
36.如示例33-35中任一项所述的假体心脏瓣膜装置，其中，所述瓣膜支承件还包括在所述第一排六边形单元格的下游端处的第一排菱形单元格和在所述第二排六边形单元格的上游端处的第二排菱形单元格。
37.如示例33-36中任一项所述的假体心脏瓣膜装置，其中，所述第一排六边形单元格沿所述下游方向向外扩口，并且所述第二排六边形单元格沿所述上游方向向外扩口。
38.如示例33-37中任一项所述的假体心脏瓣膜装置，还包括从所述第一六边形单元格的下游端突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述第一六边形单元格向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
根据前述内容，将理解的是，出于说明的目的已经在本文中描述了本发明的具体实施例，但是在不脱离本发明的范围的情况下可以进行各种修改。例如，在不同的实施例中，几个单独的部件可以彼此互换。因此，本发明并不受限制，而只如所附权利要求书所限制的。

Claims (21)

1.一种用于治疗具有天然瓣环和天然瓣叶的人类心脏天然瓣膜的假体心脏瓣膜装置，所述假体心脏瓣膜装置包括：
瓣膜支承件，所述瓣膜支承件具有流入区域和流出区域；
假体瓣膜组件，所述假体瓣膜组件在所述瓣膜支承件内；以及
锚定构件，所述锚定构件具有附连于所述瓣膜支承件的所述流出区域的基部、在部署状态下从所述基部侧向向外突出并且沿上游方向倾斜的多个臂、以及从所述臂向上游延伸的固定结构，所述固定结构具有多个支杆和多个固定元件，所述支杆限定出环形配合表面，所述环形配合表面构造成向外压靠天然瓣环，所述固定元件从所述支杆突出，其中，所述固定结构的最下游部分在平滑弯曲部处从所述臂延伸，并且所有的所述固定元件从所述固定结构沿上游方向延伸，以及其中所述臂、所述支杆和所述固定元件构造成从封壳部分地部署，且然后通过使所述封壳和所述装置中的一个相对于另一个运动而使得所述臂、所述支杆和所述固定元件滑到所述封壳中，以被重新捕获在所述封壳内。
2.如权利要求1所述的假体心脏瓣膜装置，其特征在于，所述臂在其整个长度上彼此间隔开。
3.如权利要求1所述的假体心脏瓣膜装置，其特征在于，所述固定结构的所述支杆布置在具有侧面的单元格中，并且所述臂具有第一长度，并且所述单元格的每一侧具有小于所述第一长度的第二长度。
4.如权利要求1所述的假体心脏瓣膜装置，其特征在于，每个所述臂以及所述固定结构的从每个所述臂延伸的所述支杆形成所述锚定构件的Y形部分，并且每个所述Y形部分的右侧支杆直接联接于紧邻的所述Y形部分的左侧支杆。
5.如权利要求1所述的假体心脏瓣膜装置，其特征在于，还包括从所述瓣膜支承件的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述瓣膜支承件和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
6.如权利要求1所述的假体心脏瓣膜装置，其特征在于，从所述固定结构突出的所有所述固定元件都沿上游方向延伸。
7.如权利要求1所述的假体心脏瓣膜装置，其特征在于，所述瓣膜支承件包括：
第一排第一六边形单元格，所述第一排第一六边形单元格在所述瓣膜支承件的所述流出区域处，并且所述第一六边形单元格具有第一纵向支承部；
第二排第二六边形单元格，所述第二排第二六边形单元格在所述瓣膜支承件的所述流入区域，所述第二六边形单元格具有第二纵向支承部，其中，所述第一六边形单元格和所述第二六边形单元格彼此直接相邻，使得所述第一纵向支承部直接从所述第二六边形单元格的下游顶点延伸，且所述第二纵向支承部直接从所述第一六边形单元格的上游顶点延伸；以及
其中，所述假体瓣膜组件附连于所述第一纵向支承部中的至少一个和/或所述第二纵向支承部中的至少一个。
8.如权利要求7所述的假体心脏瓣膜装置，其特征在于，所述瓣膜支承件还包括在所述第一六边形单元格的下游端处的第一排菱形单元格和在所述第二六边形单元格的上游端处的第二排菱形单元格。
9.如权利要求7所述的假体心脏瓣膜装置，其特征在于，所述第一六边形单元格沿下游方向向外扩口，并且所述第二六边形单元格沿所述上游方向向外扩口。
10.如权利要求7所述的假体心脏瓣膜装置，其特征在于，还包括从所述瓣膜支承件的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述瓣膜支承件和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
11.如权利要求1所述的假体心脏瓣膜装置，其特征在于，所述瓣膜支承件包括：
第一排的第一六边形单元格，所述第一排的第一六边形单元格在所述瓣膜支承件的所述流出区域处，其中，所述第一六边形单元格具有：第一纵向支承部、从所述第一纵向支承部向上游延伸的第一上游V形支杆、以及从所述第一纵向支承部向下游延伸的第一下游V形支杆；
第二排的第二六边形单元格，所述第二排的第二六边形单元格在所述瓣膜支承件的所述流入区域处，其中，所述第二六边形单元格具有：第二纵向支承部、从所述第二纵向支承部向上游延伸的第二上游V形支杆、以及从所述第二纵向支承部向下游延伸的第二下游V形支杆；以及
其中，所述第一六边形单元格的所述第一上游V形支杆与所述第二六边形单元格的所述第二下游V形支杆为同一支杆。
12.一种用于治疗具有天然瓣环和天然瓣叶的人类心脏天然瓣膜的假体心脏瓣膜装置，所述假体心脏瓣膜装置包括：
环形内部支承框架，所述环形内部支承框架具有流入区域和流出区域；
假体瓣膜组件，所述假体瓣膜组件在所述内部支承框架内；以及
锚定构件，所述锚定构件具有：附连于所述内部支承框架的所述流出区域的基部、以沿上游方向倾斜的角度从基部侧向向外突出的多个臂、从所述臂向上游延伸的外部固定框架、以及从所述外部固定框架突出的固定元件，其中，从所述外部固定框架突出的所有所述固定元件沿上游方向延伸，所述外部固定框架具有多个支杆，所述多个支杆限定出环形配合表面，所述环形配合表面在部署状态下与所述内部支承框架的所述流入区域径向向外地间隔开，其中，所述臂和所述支杆构造成从封壳部分地部署，然后通过使所述封壳和所述装置中的一个相对于另一个运动而使得所述臂和所述支杆滑到所述封壳中，以被重新捕获在所述封壳内。
13.如权利要求12所述的假体心脏瓣膜装置，其特征在于，所述臂在其整个长度上彼此间隔开。
14.如权利要求12所述的假体心脏瓣膜装置，其特征在于，所述外部固定框架的所述支杆布置在具有侧面的单元格中，并且所述臂具有第一长度，并且所述单元格的每一侧具有小于所述第一长度的第二长度。
15.如权利要求12所述的假体心脏瓣膜装置，其特征在于，每个所述臂以及所述外部固定框架的从每个所述臂延伸的所述支杆形成所述锚定构件的Y形部分，并且每个所述Y形部分的右侧支杆直接联接于紧邻的所述Y形部分的左侧支杆。
16.如权利要求12所述的假体心脏瓣膜装置，其特征在于，还包括从所述环形内部支承框架的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述环形内部 支承框架和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
17.如权利要求12所述的假体心脏瓣膜装置，其特征在于，还包括从所述外部固定框架突出的固定元件，并且其中，从所述外部固定框架突出的所有所述固定元件沿上游方向延伸。
18.如权利要求12所述的假体心脏瓣膜装置，其特征在于，所述环形内部支承框架包括：
第一排的第一六边形单元格，所述第一排的第一六边形单元格在所述环形内部支承框架的所述流出区域处，并且所述第一六边形单元格具有第一纵向支承部；
第二排的第二六边形单元格，所述第二排的第二六边形单元格在所述环形内部支承框架的所述流入区域处，所述第二六边形单元格具有第二纵向支承部，其中，所述第一六边形单元格和所述第二六边形单元格彼此直接相邻，使得所述第一纵向支承部直接从所述第二六边形单元格的下游顶点延伸，且所述第二纵向支承部直接从所述第一六边形单元格的上游顶点延伸；以及
其中，所述假体瓣膜组件附连于所述第一纵向支承部中的至少一个和/或所述第二纵向支承部中的至少一个。
19.如权利要求18所述的假体心脏瓣膜装置，其特征在于，所述环形内部支承框架还包括在所述第一六边形单元格的下游端处的第一排菱形单元格和在所述第二六边形单元格的上游端处的第二排菱形单元格。
20.如权利要求18所述的假体心脏瓣膜装置，其特征在于，所述第一六边形单元格沿下游方向向外扩口，并且所述第二六边形单元格沿所述上游方向向外扩口。
21.如权利要求18所述的假体心脏瓣膜装置，其特征在于，还包括从所述环形内部支承框架的下游端和/或所述基部突出的连接部延伸部，并且其中，每个所述连接部延伸部具有：形成为从所述环形内部支承框架和/或所述基部向下游延伸的V形结构的第一支杆和第二支杆、以及从所述V形结构向下游突出的连接部，其中，所述连接部被构造成由递送装置可释放地保持。
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