CN102772273A - 用于在人体内使用的置换瓣膜 - Google Patents

用于在人体内使用的置换瓣膜 Download PDF

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Publication number
CN102772273A
CN102772273A CN2012102356632A CN201210235663A CN102772273A CN 102772273 A CN102772273 A CN 102772273A CN 2012102356632 A CN2012102356632 A CN 2012102356632A CN 201210235663 A CN201210235663 A CN 201210235663A CN 102772273 A CN102772273 A CN 102772273A
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CN
China
Prior art keywords
valve
support
support element
stent
stent valve
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN2012102356632A
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English (en)
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CN102772273B (zh
Inventor
S·德拉罗耶
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Symetis SA
Jenavalve Technology Inc
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Symetis SA
Jenavalve Technology Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38924490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN102772273(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Symetis SA, Jenavalve Technology Inc filed Critical Symetis SA
Priority claimed from CN2007800412847A external-priority patent/CN101636128B/zh
Publication of CN102772273A publication Critical patent/CN102772273A/zh
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    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

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Abstract

本发明涉及用于在人体内使用的置换瓣膜。提供了一种支架瓣膜(如单支架瓣膜和双支架瓣膜)和用于通过微创手术来输送它们的相关方法及系统。

Description

用于在人体内使用的置换瓣膜
本申请是于2007年8月23日提交的已进入中国国家阶段的PCT专利申请(中国国家申请号为200780041 284.7，  国际申请号为PCT/EP2007/007413，发明名称“用于瓣膜置换的支架瓣膜和用于手术的相关方法及系统”)的分案申请。
技术领域
本发明的实施例涉及支架瓣膜和用于通过微创手术来输送它们的相关方法和系统。
背景技术
用于心脏瓣膜置换的传统方法需要在患者的胸骨(“胸骨切开术”)或胸腔(“胸廓切开术”)中切开相对较大的开口，以便允许外科医生接近患者的心脏。另外，这些方法需要停止患者的心脏，且需要心肺旁路(即使用心肺旁路机来为患者的血液充氧及使其循环)。尽管具有入侵性，这些手术方法对于第一次干预来说可以是相当安全的。然而，由第一次手术引起的组织粘附可增加与随后的瓣膜置换手术相关的风险(如死亡)。参见Akins等人的“Risk of Reoperative ValveReplacement for Failed Mitral and Aortic Bioprostheses(失效的二尖瓣和主动瓣膜生物假体的再次瓣膜置换的风险)”，Ann Thorac Surg1998；65：1545-52(胸外科年报，1998年第65卷第1545-1552页)；Weerasinghe等人的“First Redo Heart Valve Replacement-A 10-YearAnalysis(第一次重做心脏瓣膜置换-10年分析)”，Circulation1999；99：655-658(循环杂志，1999年第99卷第655-658页)，其各自通过引用而整体地结合在本文中。
人工瓣膜和生物瓣膜已经用于结果多样的心脏瓣膜置换。人工瓣膜很少失效，但却需要终生的抗凝血剂治疗，以防止血液凝结(血栓形成)于置换瓣膜中或周围。这种抗凝血剂治疗大大限制了患者的活动，且可导致各种其它并发症。生物瓣膜不需要这种抗凝血剂治疗，但通常在10-15年内就会失效。因此，为了限制对失效的生物瓣膜进行再次手术的需要及其相关的风险，传统上只有剩下不到10-15年寿命的患者接受了生物瓣膜置换。具有更长寿命预期的患者接受了人工瓣膜和抗凝血剂治疗。
已经进行了开发用于心脏瓣膜置换的入侵性更小的手术方法的尝试。这些手术方法(称为经皮心脏瓣膜置换治疗(PHVT))通过利用患者的脉管系统而使用导管将置换瓣膜输送到植入部位。这些PHVT尝试具有各种缺点，包括其无法确保置换瓣膜在患者体内的适当定位和稳定性。
考虑到前述内容，需要提供用于心脏瓣膜置换的改进的方法、系统和装置。
发明内容
本发明的某些实施例涉及用于心脏瓣膜置换的系统、方法和装置。例如，这些方法、系统和装置可应用于心脏瓣膜治疗的所有范围，包括失效的主动脉瓣、二尖瓣、三尖瓣和肺动脉瓣的置换。在某些实施例中，本发明可有利于手术通过其实施于跳动的心脏上而无需开胸腔体和心肺旁路的手术方法。这种微创手术方法可降低与起初置换失效的自体瓣膜有关的风险，以及与用以置换失效的人造(如生物或人工)瓣膜的第二次或后续手术有关的风险。
根据本发明的某些实施例的支架瓣膜可包括瓣膜构件和至少一个支架构件。瓣膜构件可包括生物或人工(如机械式)瓣膜和/或任何其它适当的材料。支架构件可包括第一部分(如近侧部分)、构造成以便容纳瓣膜构件的第二部分，以及第三部分(如远侧部分)。支架和瓣膜部分能够为至少两种构造：收缩构造(如在输送过程中)和展开构造(如植入之后)。
在某些实施例中，支架瓣膜的第一部分可包括固定元件。这种固定元件可包括(例如)用于使支架瓣膜在植入部位处固定就位的环形凹槽。当支架瓣膜包括单个支架(“单支架瓣膜”)时，环形凹槽可以构造成以便接收需要置换的瓣膜的环面。当支架瓣膜包括两个支架(“双支架瓣膜”)时，第一支架构件的环形凹槽可以构造成以便可匹配地附连到第二支架构件(即定位支架)的补充(complimentary)环形凸起上。而第二支架构件可以在植入部位处(例如)锚定到需要置换的瓣膜和/或近侧结构上。
或者或另外，在某些实施例中，支架构件的第三部分可包括至少一个附连元件。支架瓣膜的各个附连元件可包括(例如)构造成以便可移除地附连到输送装置的补充结构(complimentary structure)上的几何形开口(如圆形或卵形)、钩或带。此外，各个附连元件可以对应于接合杆的全部或一部分，两片瓣膜小叶之间的接合点可以附连到其上。附连元件可允许支架瓣膜在患者体内部分地展开，而支架瓣膜保持附连到输送装置上。当确定完全地展开支架瓣膜将导致支架瓣膜错误地安装时，这可允许支架瓣膜回复到收缩构造且在患者体内重新定位。或者或另外，当确定支架瓣膜未正确地运行时(如不允许充足的流量)，这可允许支架瓣膜回复到收缩构造且将其从患者体内移除。在某些实施例中，支架瓣膜可包括一个附连元件。在其它实施例中，支架瓣膜可包括至少两个、三个、六个或任何其它适当数量的附连元件。在某些实施例中，在附连元件的区域中的完全展开的支架直径可小于容纳相关瓣膜的区域的直径。这可降低附连元件导致的患者身体的伤害(如主动脉的穿孔)的风险，以及/或可以使得将附连元件固定到输送装置的补充结构上更加容易。
在某些实施例中，支架瓣膜的支架构件可包括具有多个单元的网格结构。网格结构可以由(例如)形状记忆合金形成，例如镍钛诺(nitinol)或任何其它适当的材料。网格结构中的单元在支架构件的包括固定元件的部分中可以是最稠密的。这可以为固定元件提供更多另外的支承，且提高支架瓣膜的稳定性。在某些实施例中，网格结构可以形成沿支架构件朝至少一个附连元件向远侧延伸的至少一个细长柱杆(如接合杆)。该至少一个柱杆可以直接连接至该至少一个附连元件。或者，网格结构可以形成用于将该至少一个柱杆连接至至少一个附连元件的至少一个支承元件。在某些实施例中，网格结构中的所有单元可以是闭合单元，其可有利于支架瓣膜从部分展开构造收回到收缩构造。
本发明的另外其它实施例涉及用于置换瓣膜的方法。提供了一种支架瓣膜，其包括具有环形凹槽的支架构件、且该支架瓣膜轴向地固定到需要置换的瓣膜的环面上。在某些实施例中，提供支架瓣膜可包括将瓣膜构件缝合到支架构件上。或者或另外，提供支架瓣膜可包括在支架构件内展开瓣膜构件，以便形成摩擦配合。在某些实施例中，提供支架瓣膜可包括用钩环(如
Figure BSA00000745809400041
)紧固系统将瓣膜构件固定到支架构件上。
在本发明的其它实施例中，提供了一种用于置换瓣膜的方法，通过该方法来植入包括环形元件的第一支架构件，从而该第一支架构件的至少一部分容纳在需要置换的瓣膜内。包括第二支架构件的支架瓣膜通过将第二支架构件的补充环形元件可匹配地附连到第一支架构件的环形元件上来定位在第一支架构件内。
在本发明的另外其它实施例中，提供了一种支架瓣膜输送系统。提供了包括外护套和导引线管的第一组件。输送系统还包括第二组件，该第二组件包括构造成用于可移除地附连到支架瓣膜的至少一个附连元件上的支架固定器。支架瓣膜可以定位在第一组件的导引线上。第一组件和第二组件可以构造成用于相对于彼此相对运动，以便从闭合位置位置转换到打开位置。在闭合位置中，外护套可以围绕仍然附连至支架固定器的支架瓣膜，且由此限制支架瓣膜的展开。在打开位置中，外护套可以不限制支架瓣膜的展开，且由此支架瓣膜可以从支架固定器上分离，并扩展成完全展开构造。
在某些实施例中，第一组件和第二组件可以构造成以便从闭合位置转换到部分地打开的位置、转换到打开位置。在部分地打开的位置中，支架瓣膜可以部分地展开，但是不会从支架固定器上分离，因为外护套可以仍然围绕支架瓣膜的至少一个附连元件和支架固定器。当支架瓣膜处于部分展开构造时，可以确定如果支架瓣膜扩展成完全展开构造，支架瓣膜是否将正确地定位。或者或另外，当支架瓣膜处于部分展开构造时，可以测试支架瓣膜的功能性(例如以便确定支架瓣膜是否将允许充足的血流)。
在某些实施例中，支架瓣膜输送系统可包括至少一个球囊(如近侧支架瓣膜或其它待输送的支架)，其构造成以便在至少一个球囊膨胀时致使支架瓣膜展开或定位支架。
在某些实施例中，支架瓣膜输送系统可包括引起第一组件和第二组件的相对运动的推柄。或者，支架瓣膜输送系统可包括用于将柄的旋转运动转换成第一组件和第二组件的相对运动的螺杆机构。
在某些实施例中，支架瓣膜输送系统可包括集成式引入器，在支架瓣膜输送到植入部位的过程中第一组件和第二组件定位在该集成式引入器内。该集成式引入器可以构造成以便即使在第一组件和第二组件被移除之后仍然保持在患者体内，以(例如)允许引入限光器。
在某些实施例中，在支架瓣膜扩展成完全展开构造之后，输送系统可以构造成以便通过使第二组件通过支架瓣膜朝向第一组件的远端传送来回复到闭合位置。
本发明的另外其它实施例涉及用于将支架瓣膜输送到植入部位的方法，支架瓣膜通过该方法可移除地附连到输送装置上，且支架瓣膜以收缩构造输送到植入部位。在使支架瓣膜保持附连到输送装置上的同时，该支架瓣膜可部分地展开。当支架瓣膜处于部分展开构造时，可以作出关于支架瓣膜的判定。当该判定获得正面响应时，支架瓣膜可以通过使支架瓣膜从输送装置上分离而扩展成其完全展开构造。
在一个特定实施例中，可以确定支架瓣膜是否正确地定位在植入部位处。当支架瓣膜没有正确地定位在植入部位处时，该支架瓣膜可以回复到收缩构造。
或者或另外，例如，通过测试瓣膜构件是否将允许充足的血流可以确定支架瓣膜的瓣膜构件是否正确地运行。当支架瓣膜未正确地运行时，支架瓣膜可以回复到收缩构造且从患者体内移除。
在某些实施例中，将支架瓣膜输送到植入部位可包括将支架瓣膜输送到心脏，以便置换心脏瓣膜。该输送可包括通过肋间间隙(如第五肋间间隙)进入患者的身体，并在心脏的顶点上刺入左心室。
附图简要描述
为了更好地理解本发明，结合附图参照以下说明，其中，相同参考标号自始至终指代相同的构件，且其中：
图1A显示了根据本发明的某些实施例的处于展开构造的瓣膜构件；
图1B显示了根据本发明的某些实施例的处于收缩构造的瓣膜构件；
图2A显示了根据本发明的某些实施例的处于展开构造的支架构件；
图2B显示了根据本发明的某些实施例的处于展开构造、包括支架构件和瓣膜构件的单支架瓣膜；
图2C显示了根据本发明的某些实施例的处于收缩构造的单支架瓣膜；
图3A显示了根据本发明的某些实施例的处于展开构造的支架构件；
图3B显示了根据本发明的某些实施例的处于收缩构造的支架构件；
图4显示了根据本发明的某些实施例的处于展开构造、包括两个支架构件和一个瓣膜构件的双支架瓣膜；
图5A-7B说明了根据本发明的某些实施例的、用以置换失效的生物(人造)瓣膜的单支架瓣膜的使用；
图8A和8B显示了根据本发明的某些实施例的、包括用于将支架固定到输送装置上的附连元件和用于将支架固定在植入部位处的固定元件的支架构件；
图8C显示了根据本发明的某些实施例的、在附连元件的区域中具有比容纳相关瓣膜的支架区域的直径更小的直径的支架构件；
图8D显示了根据本发明的某些实施例的、包括用于将支架定位/固定到植入部位处的几何形状/拓扑结构上的可独立地弯曲的元件的支架构件；
图8E显示了根据本发明的某些实施例的、包括处于冠状构造的锁定元件和用于将支架固定在植入部位处的固定元件的支架构件；
图8F显示了包括用于将瓣膜构件传送到更接近于支架构件的区域的多个支杆的支架构件，其包括用于将支架构件附连到输送装置上的附连元件；
图9A-16显示了根据本发明的、包括用于将支架固定到输送装置上的附连元件和/或用于将支架固定在植入部位处的固定元件的支架构件的另外的实施例；
图17/18、19和20显示了根据本发明的某些实施例的双支架瓣膜的另外的实例；
图21A显示了根据本发明的某些实施例的形状为相对的双冠状的支架瓣膜；
图21B-E显示了根据本发明的某些实施例的双圆锥形支架的视图；
图22A-22D显示了根据本发明的某些实施例的用于将自展开支架瓣膜输送到植入部位的输送系统；
图23A-23D显示了根据本发明的某些实施例的具有可膨胀球囊的输送系统；
图24A-24D显示了根据本发明的某些实施例的具有增加了直径的近侧外轴的输送系统；
图25A-25C显示了根据本发明的某些实施例的具有可膨胀球囊的输送系统；
图26A-26C显示了根据本发明的某些实施例的具有集成式引入器的输送系统；
图27是根据本发明的某些实施例的涉及置换失效的自体或人造瓣膜的示意性阶段的流程图；以及
图28A-C说明了根据本发明的某些实施例的通过使用输送系统来置换失效的瓣膜。
具体实施方式
图1A-3B显示了根据本发明的某些实施例的用于置换(例如)失效的(如退化的)主动脉瓣、二尖瓣和肺动脉瓣(如在小儿科患者中)的构件100、200和300。更具体地，图1A和1B显示了瓣膜构件100。图2A-2C显示了用于容纳瓣膜构件100的支架构件200。图3A和3B显示了用于容纳支架构件200和瓣膜构件100的支架构件300。包括构件100和200的装置可称为单支架瓣膜。另外包括构件300的装置可称为双支架瓣膜。
图4显示了根据本发明的某些实施例的包括瓣膜构件100、支架构件200和支架构件300的双支架瓣膜400。双支架瓣膜400可置换失效的自体或人造瓣膜。如本文所用，“自体瓣膜”指的是天然地存在于患者体内的瓣膜。失效的自体瓣膜可以是(例如)狭窄瓣膜。“人造瓣膜”指的是通过手术引入患者体内的生物或人工(如机械式)瓣膜。用于装置400(或其它置换瓣膜)的植入部位通常包括失效的瓣膜内和/或沿着近侧结构的至少一部分的区域的至少一部分。例如，为了置换失效的主动脉瓣膜，装置400可以植入患者体内，从而装置的部分402基本上全部定位在失效的主动脉瓣膜内。装置400的部分404可以沿主动脉的至少一部分延伸。装置400的部分406可以延伸到患者心脏的左心室的至少一部分中。
双支架瓣膜400可使用任何适当的输送方法输送到植入部位。在本发明的某些实施例中，在装置400输送到植入部位之前，装置400可以在患者体外由构件100、200和300基本完整地组装起来。在本发明的其它实施例中，装置400的构件100、200和300可以按多个步骤单独地输送到植入部位。例如，支架构件300可以输送及安装在植入部位处，接着按一个或多个单独的步骤输送和安装支架构件200和瓣膜构件100。在一个实施例中，构件100和200可以在患者体外组装，然后将其同时输送和安装在构件300内。在另一个实施例中，支架构件200可以输送和安装到支架构件300内，接着以单独的步骤输送和安装瓣膜构件100。结合图17-20描述了双支架瓣膜的另外的实施例。
在本发明的某些实施例中，包括瓣膜构件100和支架构件200(但不包括支架构件300)的单支架瓣膜(图2B)可用于置换失效的自体或人造瓣膜。例如，在一个特定实例中，单支架瓣膜可以在先前的瓣膜置换手术的过程中置换引入患者体内的失效的生物瓣膜。因此，涉及图2B所示的单支架瓣膜的手术可以是第二次或后续的瓣膜置换手术。虽然在这个实施例中没有新的支架构件300可引入患者的身体，但是包括构件100和200的单支架瓣膜可以由保持在来自先前的瓣膜置换手术的植入部位处的支架和/或瓣膜容纳。在某些实施例中，在将单支架瓣膜安装在植入部位处之前，可以移除来自先前的手术的支架和/或瓣膜的至少一部分。结合图5A-7B描述了关于用单支架瓣膜置换失效的生物瓣膜的另外的细节。
在本发明的某些实施例中，瓣膜构件100可以是柔性和可收缩的，使得其在(例如)通过导管输送到植入部位的过程中可以收缩。以下结合图22A-26C描述了用于微创手术的输送系统和手术方法的各种实施例。在输送时，瓣膜构件可以至少部分地展开。图1A是处于展开构造的瓣膜构件100的透视图。图1B是处于收缩构造的瓣膜构件100的透视图。如本文所用，“收缩构造”和“展开构造”指的是(例如)构件的直径和/或任何其它物理特征(如长度、宽度)的相对差异。例如，图1B所示的收缩的瓣膜构件具有减小的直径，且可具有或可不具有比图1A所示的展开的瓣膜构件更长的长度。
瓣膜构件100可包括生物材料(如鞣制的、未鞣制的、异质或自体的)、非生物材料、人工材料(如诸如聚亚安酯和/或硅等聚合物)或者其组合。在某些实施例中，瓣膜构件100可包括保存的生物组织，例如，诸如人类组织(如瓣膜组织的同种移植物、自体移植物)或动物组织(异种移植或异体移植瓣膜组织)。在某些实施例中，瓣膜构件100可以是机械式瓣膜。例如，当瓣膜构件100是生物瓣膜时，瓣膜构件100从收缩构造到展开构造的展开可能需要固定的支架构件200的自展开。相反，人工瓣膜构件100能够自展开。瓣膜构件100可具有与期望的瓣膜应用(如三尖瓣、肺动脉瓣、二尖瓣或主动脉瓣)的形状/形式(如长度、宽度、直径等)相对应的形状/形式。在图1A和1B中，瓣膜构件100是具有三片片状物的三尖瓣。这个特定构造可以特别适用于(例如)置换失效的主动脉瓣。在其它实施例中，瓣膜构件100可具有任何其它适当数量的片状物和/或其它物理特征(如直径、长度、宽度等)。
图2A是根据本发明的一个实施例的支架构件200的透视图。如图2B所示，支架构件200容纳了瓣膜构件100。在某些实施例中，支架构件200的至少一部分在形状上可基本为圆柱形。或者或另外，支架构件200可具有(例如)用于使支架在植入部位处固定就位的缺口(如环形凹槽)或其它固定元件202。例如，当支架构件200是双支架瓣膜400(图4)的一部分时，固定元件202可以可匹配地附连到支架构件300的补充固定元件302(如图3A的向内的环形凸起)上。当支架构件200是单支架瓣膜(图2B)的一部分时，固定元件202可以固定到失效的瓣膜的至少一部分上。结合图6A和8A-16描述了可包括固定元件的支架构件的另外的实施例。
在本发明的某些实施例中，支架构件200、类似的瓣膜构件100能够为至少两种构造：第一，收缩构造(如在输送过程中)和第二，展开构造(如安装之后)。图2A显示了处于说明性的展开构造的支架构件200。图2C显示了处于说明性的收缩构造的支架构件200，其中收缩的瓣膜构件100容纳在支架构件200中，(例如)以便将两个构件同时输送到植入部位。在某些实施例中，支架构件200可以由线材制成，或可以由管子、护套等激光切割而成。支架构件200可包括形状记忆合金材料，例如镍钛诺。形状记忆合金可允许将支架构件200(和/或瓣膜构件100)压缩成第一构造，以便(例如)通过患者身体中的小开口输送支架构件200，并且在安装过程中使支架构件200扩展成第二构造。例如，构件100和/或200可以用例如护套或遮罩保持成收缩构造。可以移除护套/遮罩，以便允许构件100和/或200重新构造成第二构造。
瓣膜构件100可以通过任何适当的固定机构或固定机构的组合固定到支架构件200上。例如，在一个实施例中，瓣膜构件100可以用一个或多个针脚来缝合到支架构件200上。在另一个实施例中，瓣膜构件100可以通过摩擦配合的方式固定到支架构件200上。例如，瓣膜构件100可具有稍微大于支架构件200的展开直径的完全展开直径，从而当构件100在构件200内展开时，构件100和200牢固地配合在一起。在又一个实施例中，钩环型(例如
Figure BSA00000745809400111
)紧固系统可用于将瓣膜构件100固定到支架构件200上。例如，支架构件200可包括显微钩，且瓣膜构件100可包括相应的显微环(或反之亦然)。这种钩环紧固系统可包括微丝绒材料，其以前已经被用于手术应用来改进生长的组织。例如在构件100和200已经植入患者体内之后，这种钩环紧固系统可允许相对于支架构件200的位置微调瓣膜构件100的位置。钩/环还可有利于血液凝固以及瓣膜构件100和支架构件200之间的接合处的密封的形成。为了避免过早形成凝结(如安装完成之前过度地形成凝结)，可以为患者提供抗凝血剂监测和/或治疗。可靠的钩环连接仍然可以在存在过早的凝结形成的情况下实现，但可能需要更高的激活压力(在以下描述)。初步评估显示，可靠的钩环连接可以在存在水、胶体质、液体皂和/或凝结蛋白质的情况下形成。在某些实施例中，这种钩环紧固系统可以备选地或另外地用于将支架构件200固定到支架构件300上(例如用附连到支架构件200的外表面上的显微钩和附连到支架构件300的内表面上的相应的显微环，或反之亦然)。
任何适当的机构或这些机构的组合(如机械压缩的直接或间接施加)可用于提供使显微钩附连到显微环上所需的激活压力。例如，在某些实施例中，一个或多个球囊可布置成邻近瓣膜构件100和/或支架构件200(如在瓣膜构件100内)，且其可以暂时地膨胀，以使显微钩与显微环发生接触。在将支架和/或瓣膜输送到植入部位之后，这种球囊可置于瓣膜构件100和/或支架构件200内。或者，在某些实施例中，在将支架和/或瓣膜输送到植入部位之前(如在将支架和/或瓣膜载入输送装置中之前)，球囊可以安装(如可移除地安装)到瓣膜构件100和/或支架构件200内。这种球囊的使用不限于瓣膜和支架在其中通过钩/环的方式而彼此固定的实施例。相反，需要或期望使用球囊来协助支架和/或瓣膜在植入部位处展开和/或接合的任何时候(例如当瓣膜缝合到支架上时)都可以使用这种球囊。在某些实施例中，可以提供在支架构件200内自展开的自展开瓣膜构件100，以便使得显微钩接触显微环。
图3A是根据本发明的一个实施例的支架构件300的透视图。如前所述，支架构件300可具有可匹配地附连到支架构件200的补充固定元件202(图2A)上的固定元件302(如向内的环形凸起)。图4显示了这种可匹配的附连的一个实施例，其中，构件300容纳了构件100和200两者，以形成双支架瓣膜400。支架构件300的几何形状(如长度、宽度、直径等)可以特别适用于(例如)主动脉瓣置换。在其它实施例中，可以提供支架构件300的其它几何形状和构造。
通过使用任何适当的固定机构或固定机构的组合，支架构件300可以在植入部位处固定就位。例如，在某些实施例中，固定元件302可以形成用于接收失效的瓣膜的至少一部分的凹槽(如外部环形凹槽)。在某些实施例中，支架构件300可具有稍微大于植入部位的直径的直径，从而使得支架构件300在植入部位处的输送和展开通过摩擦配合的方式将支架构件300固定就位。在某些实施例中，支架构件300可包括用于将支架构件300在植入部位处锚定到失效的瓣膜和/或近侧结构上的一个或多个凸起(如长钉)或扣钩。
图5A-7B说明了本发明的用于置换在先前的手术过程中引入患者身体的失效的人造(如生物)瓣膜(如支架瓣膜)的实施例。图5A是失效的生物瓣膜500的透视图，其中瓣膜的小叶502无法闭合。图5B是植入图2B所示的支架瓣膜之后的失效的生物瓣膜500的透视图。如图所示，失效的生物瓣膜500(例如：和/或其伴随支架)使新的支架瓣膜在植入部位处固定就位。更具体地，支架瓣膜的固定元件202(图2A和2B)(其可以是形成支架瓣膜的最狭窄部分的环形凹槽)可以接收失效的生物瓣膜500的环面，从而使支架瓣膜固定就位。在本发明的其它实施例中，失效的生物瓣膜500的至少一部分(例如失效的瓣膜自身)可以从患者体内移除，而失效的瓣膜的其它部分(如支承支架)可以留在植入部位处。在另外其它实施例中，在安装新的支架瓣膜之前，可将包括所有其相关构件的失效的生物瓣膜500基本上完全从植入部位中移除。
图6A是根据本发明的一个实施例的支架瓣膜600的另一个实例的透视图。图6B是显示了使用支架瓣膜600来置换失效的人造(如生物)瓣膜的透视图。支架瓣膜600包括沿着支架构件的外表面的一个或多个(如三个)锁定或保持元件602。各个锁定元件602可包括方向性，使得其在该锁定元件与另一个表面(如导管的内部)接合时就收缩(如变得与支架构件的外表面齐平)。当锁定元件602从支架构件的外表面突出时，锁定元件的第一端604可以邻近支架构件的外表面，而锁定构件的第二端606可与支架构件的外表面间隔开。当提供了多个锁定元件602时，所有锁定构件的第一端604可以沿着支架构件的中心轴线定位在基本相同的竖直高度/位置上(如虽然围绕支架构件的周边均匀地分散)，且第二端606可以定位在与第一端604不同的竖直高度/位置上。第一端604可以是柔性的(如允许沿两个维度以类似铰链的方式运动)，从而第二端相对于支架构件的外表面的运动不会妨碍锁定机构。
在本发明的某些实施例中，支架瓣膜600可以沿图6B中的箭头608的方向插入失效瓣膜的内部。当各个锁定元件602的第一端604遇到失效的瓣膜的内径/环面时，锁定元件的第二端606可朝向支架构件的外表面收缩。当锁定元件的第二端606到达失效的瓣膜的开口区域时，第二端可以向外突出，从而使支架瓣膜600锁定就位。因此，作为用于将支架瓣膜600固定到(例如)失效的瓣膜的环面上的支架构件的固定元件610(如环形凹槽)的备选或另外的方案，锁定元件602可以提供用于使新的支架瓣膜固定就位的机构。
图7A和7B显示了根据本发明的具有锁定元件的支架构件700的另一个实施例。图7A显示了这种支架构件可由(例如)适当的材料(如镍钛诺)片制成。参看图7B，支架构件700包括一个或多个锁定元件702，其从支架构件的外表面径向地延伸，从而使得对于各个锁定元件、该锁定元件的第一端704和第二端706沿着支架构件的中心轴线具有基本相同的竖直位置/高度。在其他实施例中，这种锁定元件可以稍微地成角度，使得同一锁定元件的端部704和706沿着支架构件的中心轴线具有不同的相对竖直位置/高度。在某些实施例中，可以提供包括多个锁定元件的支架构件，其中各个锁定元件具有以不同角度定向的端部704和706。不同的锁定元件702可沿着支架构件的中心轴线具有相同或不同的竖直位置/高度。
图8A-16显示了根据本发明的某些实施例的用于瓣膜置换的适当支架构件的另外的实例。这些支架构件可(例如)作为单支架瓣膜和双支架瓣膜的一部分使用。这些支架构件各自都包括用于将支架构件(例如连同集成式瓣膜构件)可移除地附连到输送装置上(图22-26)的一个或多个附连元件。在某些实施例中，这些支架构件还可包括用于使支架构件在植入部位处固定就位的固定元件(如类似于固定元件202(图2A))。
图8A显示了处于收缩构造的支架构件800的透视图，以及支架构件800的说明了关于其结构的细节的类似切割的视图。图8B显示了处于展开构造的支架构件800。支架构件800包括：第一(如近侧)部分802，其包括固定元件(如环形凹槽)；可遵循瓣膜构件的轮廓以容纳在其中的第二部分804；以及包括一个或多个(如三个)附连元件808的第三(如远侧)部分806。在某些实施例中，支架构件800可包括(例如)网格结构(如由镍钛诺制成)，例如，部分802具有比部分804和/或部分806更稠密的网格单元。这可以为部分802中的固定元件提供另外的支承，且由此提高装置800在植入部位处的稳定性。在某些实施例中，支架构件800可以仅包括闭合的网格单元，以便有利于在支架构件800处于部分展开构造时，由输送装置重获支架构件800(如以下所述)。
在某些实施例中，附连元件808各自可包括用于将支架构件800可移除地附连到输送装置的补充元件上(如线材、带或钩)的开口(如圆形或卵形)。附连元件808可以在使支架构件保持附连到输送系统上的同时允许支架构件(如连同集成式瓣膜构件和/或另一个支架构件)在患者体内部分地展开，例如，当支架构件800在输送过程中从轴中部分地释放时，支架构件800的部分802和804(如以及部分806的一部分)可展开，而观察不到仍由轴约束的附连元件808的相对位置的变化(如参见图28的“部分释放”)。这可允许外科医生在最终确定支架瓣膜在植入部位处的部署之前在患者体内重新定位支架瓣膜(或双支架瓣膜)和/或测试其功能性。对瓣膜功能性进行的这种测试可包括周边脉搏监测，如果瓣膜正确地运行，则通过这种方法脉搏波是可测量的。支架瓣膜功能的更可靠的评估可用经食管超声心动图(TEE)、血管内超声显像(IVUS)和/或心腔内超声心动图(ICE)来进行。如果支架瓣膜在测试过程中出故障(例如，如果瓣膜没有允许充足的血流)，支架瓣膜可以由输送装置完全地重获且从患者体内取回。在其它实施例中，支架构件800可具有不同的网格结构，附连元件808的长度和/或其它尺寸可以缩小或放大，以及/或附连元件808可包括在相对于支架构件800的其它位置中(如部分804内)。
图8C显示了具有集成式附连元件814的支架构件的另一个实施例，该集成式附连元件814构造成使得附连元件的区域中的完全展开的直径小于容纳相关瓣膜的区域的直径。如此实例所示，附连元件朝支架构件的中心轴线部分地向内凸出。这可降低附连元件对患者身体造成伤害(例如主动脉的穿刺)的风险。或者或另外，这可使得将附连元件固定到输送装置的补充结构上更加容易。例如，当装置收缩以便于附连到输送装置上时，附连元件的区域内的缩小的直径可使附连元件更早地与支架固定器接合。
图8D显示了根据本发明的支架构件的又一个实施例。在这个实施例中，支架的第一(近侧)部分包括27个独立的可弯曲元件816，其各自可包括可以打开和/或闭合的连接/和或断开的单元。在这个实施例中，各个可弯曲元件包括单个闭合单元。在其它实施例中，可以提供其它数量和/或构造的可弯曲元件。可弯曲元件816允许近侧支架部分精确地定位/固定到(例如)钙化的环面/失效的生物瓣膜的几何形状/拓朴结构上。各个元件816可以独立地弯曲/适应钙化的环面/失效的生物瓣膜的紧邻部分的拓朴结构。可弯曲元件816共同形成环形凹槽，在该环形凹槽中，用于各个可弯曲元件的弯曲变形(有凹槽的部分)的位置通过缩小或延长用作接头的一对附连的支架支杆(818，820)的长度来控制。单个支架支杆的长度由标号822示出。首先，在支架制造过程中，各个可弯曲元件816的径向力/阻力受角度824的选择的影响。诸如支杆厚度/宽度的其它设计参数也会影响径向力。这种设计的优点是：支架近侧部分可以更充分地使支架在植入部位处锚定就位，而不受支架中间部分影响。因此，支架中间部分可以设计成以便容纳(例如)主动脉瓣膜，而不超出尺寸，从而降低由于长期的机械应力引起的瓣膜失效的风险。图8D的支架还包括用于在制造和/或弯曲过程中调节支架内的延长失配(如果有的话)的补偿元件826(如包括三角波浪部分和两个细长臂)。图8D与图8C所示的实施例相反，其中，专用的支杆对的缺少防止了支架近侧部分具有独立地弯曲的元件(如在植入过程中)。
图8E显示了根据本发明的支架构件的另一个实施例。在图8E中，显示了支架构件的类似切割的视图的仅约1/3，以便更清楚地显示其特征。与图6A和6B所示的锁定/保持元件602相似，图8E所示的支架构件包括大体定位在图8B中作为区域804来引用的支架构件区域内的多个可独立地弯曲的锁定元件828。锁定元件828形成可以从流出侧接合(例如)失效的生物瓣膜或钙化的自体环面的冠。图8E中的支架构件还包括固定元件830(如环形凹槽)。在图8E中，显示了锁定元件828沿着支架构件的中心轴线定位在基本相同的位置/高度上。在其它实施例中，不同的锁定元件828可类似于(例如)图7B所示的支架而沿着支架构件的中心轴线具有相同或不同的竖直位置/高度。锁定元件828中的至少某些锁定元件具有不同的位置/高度可有利于与(例如)不同尺寸的自体瓣膜(例如可由间隔开小距离的锁定元件接合的薄的自体瓣膜，或者仅能由间隔开较远的锁定元件接合的厚的自体瓣膜)相接合。
图8F显示了根据本发明的支架构件的另一个实施例。在图8F中，显示了支架构件的类似切割的视图的仅约1/3，以便更清楚地显示其特征。图8F包括用于容纳瓣膜构件的达可纶(Dacron)袋832，其中，达可纶袋沿着瓣膜自由边834缝合。如图所示，袋832内的瓣膜构件在图8F的实施例中比图9C所示的实施例中容纳得更加靠近附连元件836，该附连元件836与图8B中的附连元件808相似。中间的倒置U形支杆838滑入达可纶袋832中。瓣膜/袋缝合到外部的倒置U形支杆840上。内部U形支杆842定位在达可纶袋832外面，且在通过减小达可纶袋832和外护套之间的摩擦力而利用输送装置装入/释放/重获植入物的过程中用作刹车。内部U形支杆842也可以缝合到达可纶袋832上。在某些实施例中，达可纶袋832可以用其它缝合844来闭合。虽然未在图8F中示出支架的底部，但是在某些实施例中，其可包括(例如)与图8B中的固定元件802相似的固定元件(如环形凹槽)。
图9A-9C显示了根据本发明的一个实施例的具有集成式附连元件902的支架构件900的另一个实例。图9A显示了处于收缩构造的支架构件900的透视图和支架构件900的说明了关于其结构的细节的类似切割的视图。图9B是处于展开构造的支架构件900的透视图。图9C显示了支架构件900(具有集成式瓣膜构件)，其定位在标尺旁边以显示其尺寸(如约4厘米)。如图所示，各附连元件902包括通过两个支承元件904(如线材)附连到支架构件900上的圆形或卵形开口。而各对支承元件904都附连到网格结构内的柱杆906(如接合杆)上。相反，图8B中的附连元件808的其中各个通过单个支承元件810附连到支架构件800上，且各个支承元件810都附连到柱杆812上。图8A-16所示的所有支架构件都包括三根柱杆，但是应当理解，根据本发明的某些实施例，可以提供其它适当数量的柱杆或完全不提供柱杆(如图2A)。支架构件900还包括可与固定元件202(图2A)基本上相似的固定元件908。在图9C的实施例中，瓣膜构件围绕其环面的周围缝合。瓣膜构件的三个小叶的其中各个小叶还点缝合到支架上，以允许瓣膜功能性。可以选择缝合的位置，以便允许在褶皱期间延长支架而不损坏瓣膜或缝合。例如，可在支架的内侧上用织物(如网状物)覆盖流入物(如在图8B所示的区域802内)。织物和瓣膜构件可以在近侧环形凹槽的区域中(如沿着图8B中的支架部分802和804的边界)缝合到支架上(如使用连续的和/或中断的技术)。流入侧上的某些多余织物可以折叠到支架的外侧上，且在先前缝合位置附近(如进一步朝向部分804)与瓣膜构件缝合在一起。瓣膜构件的接合处还可以附连到可能已在之前用织物(如达可纶)覆盖的对应支架杆上。或者，可用心包膜或其它适当的材料来覆盖支架构件。在某些实施例中，瓣膜构件可以是猪瓣膜构件，其可以这样获取或从各个捐赠人处汇集，以便具有三尖之间的最佳匹配。还可以使用由心包膜制成的牛瓣膜和马瓣膜。也可以使用瓣膜构件的其它适当的来源。
图10A-10B显示了根据本发明的一个实施例的具有集成式附连元件1002的支架构件1000又一个实例。图10A显示了处于收缩构造的支架构件1000的透视图和支架构件1000的说明了关于其结构的细节的类似切割的视图。图10B是处于展开构造的支架构件1000的透视图。如图所示，附连元件1002中的至少一对(如所有对)利用支撑元件1004彼此附连。各个支撑元件1004可以在一端上附连到第一附连元件1002上，且在另一端上附连到第二附连元件1002上。在某些实施例中，支撑元件1004可包括成形为类似三角波浪的线材。当所有附连元件1002包括支撑元件1004时，支撑元件1004可共同形成围绕支架构件1000的周边的圆环。支架构件1000在所有其它方面可与支架构件800(图8B)基本相同。
图11-16显示了根据本发明的某些实施例的具有集成式附连元件的支架构件的另外的实例。图11-16中的各图都包括处于收缩构造的支架构件的透视图和支架构件的说明了关于其结构的细节的类似切割的视图。以下说明概括了图11-16所示的支架构件的各种特征。根据附图，对本领域技术人员而言，图8A-16所示的实施例的另外的结构性特征将显而易见。
图11显示了包括用于附连到对应数量的卵形/圆形附连元件上的更短的支承元件(即与图8B的支承元件810相比更短)的支架构件。图11中的用于附连到支承元件上的柱杆可与图9B中的柱杆906基本相同。
图12显示了包括用于附连到各个卵形/圆形附连元件上的两个支承元件的支架构件。各对支承元件都附连到柱杆，从而支承元件和柱杆共同时形成(例如)用于增加的支承和/或用于用作另外的或备选的附连元件的第二卵形/圆形开口。图12中的柱杆可与图9B中的柱杆906基本相同。
图13显示了包括用于可匹配地附连到输送装置的补充元件上(如圆形或/卵形开口)的非圆形/卵形附连构件(例如，诸如线材、钩、带或其组合)的支架构件。当与支架构件900(图9A和9B)的附连元件数量(如三个)相比较时，图13中的支架构件还包括更多数量的附连元件(如六个)。在图13中，附连元件直接附连到支架构件的柱杆上，每根柱杆上附连两个附连元件。图13中的柱杆可与图9B中的柱杆906基本相同。
图14显示了用长窄开口(如与图9A的附连元件902相比长且狭窄)代替图13中的线材/钩附连元件的支架构件。图14中的柱杆可与图9B中的柱杆906基本相同。
图15显示了具有经修改的网格结构(包括经修改的柱杆结构)的支架构件。图15中的支架构件还包括圆形/卵形附连元件，其中各个附连元件通过两个支承元件附连到柱杆。各对支承元件和对应的柱杆可以按类似于图12所示的支承元件/柱杆构造的方式形成第二圆形/卵形开口。
图16显示了具有相对于图15所示的附连元件进行了修改的附连元件的支架构件。图16中的各个附连元件包括线材(如“U”形线材)，其中线材的两端直接附到同一柱杆上，从而附连元件/柱杆构造形成基本卵形/圆形的开口。图16中的柱杆可与图15所示的柱杆基本相同。
图17/18、19和20显示了根据本发明的某些实施例的双支架瓣膜的另外的实例。图17的单支架瓣膜1700包括支架1702和瓣膜构件1704。图18显示了包括支架瓣膜1700和定位支架1802的双支架瓣膜，支架瓣膜1700和定位支架1802可通过(例如)环形凹槽和相应的环形凹陷附连到一起。支架构件1802可以覆盖有(例如)心包膜，以便防止瓣膜周围泄露。图18的双支架瓣膜可具有适用于(例如)肺和/或主动脉应用的大体圆柱形的形状。
现参看图19和20，图19显示了具有第一支架1902、第二支架1904和瓣膜构件1906的双支架瓣膜。图20显示了具有第一支架2002、第二支架2004和瓣膜构件2006的双支架瓣膜。此外，可以覆盖(如用心包膜)图19和20中的定位支架，以便防止瓣膜周围泄露。图19和20的支架可以适用于(例如)肺瓣膜置换(如在有产生变形的动脉瘤的情况下，以及在没有用于带凹槽支架瓣膜的置换的合适边缘的情况下)。更具体地，关于肺瓣膜应用，许多肺瓣膜置换的候选具有动脉瘤或在流入或流出处具有漏斗型构造。因此，第一支架1902和2002可以适于这种漏斗型肺动脉构造，且可以提供用于固定支架瓣膜(1904，1906)或(2004，2006)的圆孔。在某些实施例中，可以提供与图20的双支架瓣膜相似的双支架瓣膜，其适用于二尖瓣和/或三尖瓣应用，其中定位支架具有减小的高度和提供用于附连到支架瓣膜凹槽(或者，可以使用钩环紧固系统)的圆形边缘的椭圆形构造。或者或另外，定位支架可具有在植入部位处提供固定配合的可独立地弯曲的元件。根据附图，图17-20所示的实施例的另外的结构性特征和关于其用于瓣膜置换的用法的细节对本领域技术人员而言将显而易见。
图21A显示了根据本发明的某些实施例的支架瓣膜2100的另一个实例。图21A所示的实施例可以适于(例如)二尖瓣置换。支架瓣膜2100可以在支架瓣膜2100输送到植入部位之前，在患者体外由支架构件和瓣膜构件装配而成。支架瓣膜2100可以是适于置换二尖瓣的自展开支架瓣膜。如图所示，支架瓣膜2100可具有类似于相对的双冠的形状。支架瓣膜2100可包括缝入达可纶导管(修复管)中的猪肺瓣膜2102，两个自展开镍钛诺Z支架2104和2106以产生两个自展开冠的方式缝合到假体的外表面上。可以装载自展开支架瓣膜，以便将其输送到特氟纶护套或其它合适的输送系统中。在这个实施例中，达可纶用于覆盖支架，但是在其它实施例中可以使用其它材料，例如特氟纶、硅、心包膜等。在一个手术方法中，可以在左心房上产生1厘米的切口，其由荷包缝合控制。可以沿着导引线(已用针和插入的导引线刺穿的心房)推动具有装入的支架的特氟纶护套，直到支架瓣膜的中部到达二尖瓣环面。然后，可以拉回护套，以首先部署心室侧，接着全部移除护套，以暴露心房侧。在Liang Ma等人的“Double-crownedvalved stents for off-pump mitral valve replacement(用于非体外循环二尖瓣置换的双冠瓣膜支架)”，European Journal of Cardio-ThoracicSurgery 28：194-199，June 13，2005(欧洲心胸外科期刊，2005年6月13日出版第28卷第194-199页)中描述了关于支架瓣膜2100和用于将其输送到植入部位的手术方法的另外的细节，其通过引用而整体地结合在本文中。
图21B-E显示了根据本发明的某些实施例的双圆锥形支架的视图。参看图21B和21C，双圆锥形支架可包括携带瓣膜2110的基本圆柱形的支架2108和固定/附连到支架2108上(如用
Figure BSA00000745809400221
缝合线、摩擦配合、其他适当的固定机构或其组合)的基本上为圆锥形的支架(2112，2114)。图21D显示了图21B和21C所示的双圆锥形支架的截面。在其它实施例中，支架2112和2114中的至少一个可具有冠形，该冠形具有由打开或闭合的单元或Z支架形成的突出钉。第一和第二另外的支架(2112，2114)可共同形成与图2A所示的固定元件202相似的固定元件2116(图21C；如环形凹槽)。固定元件2116可允许固定在(例如)失效瓣膜的小孔中(其具有与与携带瓣膜构件2110的支架2108类似的尺寸)，或者固定到具有补充环形凸起的锚定支架上。在某些实施例中，支架2112和2114(以及可选地支架2108)可以用呈双圆锥形构造(如在固定元件2116的区中由连续区域连接的两个锥形物)的单个支架来代替。使用用于锥形物/固定元件的单独支架的优点是，锥形物/固定元件(如第一支架2112和第二支架2114)的机械应力可以至少部分地隔离包含瓣膜的支架2108。在某些实施例中，定位成接近于输送系统的尖端(如支架2112)的至少另外的支架或其部分可以由输送系统重获。为了有利于这种重获，可以使另外的支架形成为棱锥形或翼形截面构造2118(图21E)。在某些实施例中，可以在沿着与(例如)图7B所示的支架相似的支架2108的中心轴线的各个位置/高度处形成支架2112(和/或2114)的翼或钉。至少某些翼或钉具有不同的位置/高度可有利于与(例如)具有不同尺寸的自体瓣膜的接合。在某些实施例中，图21B-21E所示的支架(如支架2108)可包括用于可移除地附连到输送装置的至少一个附连元件，其与图8B所示的附连元件808相似。
图22A-26C显示了根据本发明的某些实施例的用于将支架瓣膜(如单支架瓣膜或双支架瓣膜)输送到植入部位的输送系统的实例。在某些实施例中，本发明提供了微创手术方法，通过该方法，在跳动的心脏上实施手术而不需要开胸腔体和心肺旁路。可以通过患者体内相对较小的开口(例如)经顶部刺入心脏。例如，为了置换失效的主动脉瓣，可以通过肋间间隙(如第五肋间间隙)刺入患者的身体，肋间间隙是两根肋骨之间的区域。从这个进入点，可以在心脏的顶部上刺入左心室。在一个方法中，适当的支架瓣膜输送系统(如包括集成式引入器的输送系统2600(图26A-26C))可以首先剌入身体/心脏。在另一个方法中，可以使用单独的引入器护套。可以使导引线(空心针、导管、刚性导引线等)插入穿过引入器，以引导(例如)支架构件、瓣膜构件和/或其它装置(如限光器装置)的输送。在某些实施例中，经腔、经心房或经心室进入方法可用于(例如)三尖瓣和/或二尖瓣置换。还可进入心脏的右心室以进行肺瓣膜置换。这与通过开胸腔体输送置换瓣膜的其它手术方法相反。此外，如以下结合图22A-28C更详细地描述，根据本发明的某些实施例的输送系统首先释放支架瓣膜的近侧部分，当(例如)以经腔壁的方式进入身体时，这可允许测试瓣膜。一旦测试成功，就可以释放支架瓣膜的远侧部分。这与首先释放其相关支架的远侧部分的支架输送系统相反。
图22A-22D显示了包括两个同心地设置的部分、第一组件(包括元件2202-2210)和第二组件(包括元件2216-2230)的输送系统2200。更具体地，第一组件可包括位于输送系统(其中导引线穿过输送系统的长度且穿出尖端)的远侧上的尖端2202、内轴2204、外护套2206、金属轴2208和推柄2210。第二组件可包括外轴(远侧)2216、锥形外轴连接件2218、外轴(近侧)2220、支架固定器2222、活套保护器2224、握柄连接件2226、握柄杯2228和O型圈2230。如图所示，推柄2210定位在输送系统的近侧端处。在图22A和22B中，外轴2220已经沿其长度分开，以允许输送系统2200的构件更详细地显示出来。瓣膜2212和支架2214形成可以(例如)装入第一和第二组件之间，且可以在它们之间褶皱的第三组件。
关于第一组件，内轴2204用作用于导引线的内腔。尖端2202在其远侧上结合。如本文所用，结合指的是任何适当的固定/紧固机构，诸如，例如使用氰基丙烯酸盐或紫外光固化胶粘剂的粘接结合，或者使用热能来熔化待装配构件的热结合/焊接。外护套2206可以结合到尖端2202的近端部分上，且可以约束支架瓣膜(2212，2214)。可以对外护套2206进行穿孔，以允许通过握柄2210进行装置冲洗。可以用金属轴2208来增强第一组件的近侧部分，且其可以终止于具有用于导引线内腔冲洗的鲁尔(luer)连接件的握柄远侧中。
关于第二组件，支架固定器2222可以在远侧结合到远侧外轴2216上。图22D显示了更好地说明支架瓣膜(2212，2214)和支架固定器2222之间的布置的透视图。远侧外轴2216可以通过渐缩连接件2218近侧地结合到近侧外轴2220上。邻接外轴2220可以通过活套保护器2224结合到握柄组件上，该握柄组件可包括握柄连接件2226和握柄杯2228。握柄组件可以压缩O型圈2230，以便密封输送系统2200。鲁尔(luer)连接件可允许装置冲洗。冲洗机构可用于在输送系统插入身体中之前从该输送系统中移除截留空气。或者或另外，冲洗机构可用于在释放和/或重获支架之前通过用冷盐水溶液冲洗支架来冷却该支架(如镍钛诺支架)。冷却支架可以导致其结构的可逆修改，因此减小其杨氏(Young)模量，并且由此减小支架径向力和用于其输送和重获所必需的力。
当(例如)推柄2210接触握柄杯2228时，声称输送系统2200处于打开位置(图22C)。在打开位置中，支架瓣膜(2212，2214)可以从支架固定器2222上分离，且可在植入部位处完全展开。在输送系统2200到达打开位置之前，支架瓣膜可以通过(例如)褶皱机构而褶皱在输送系统2200上，且由支架固定器2222保持就位。支架固定器2222可以固定到图8A-16所示的支架的附连元件上。褶皱的支架瓣膜可以通过拉回第一组件而保持收缩构造，由此用外护套2206覆盖附连构件/支架固定器2222。当移除了外护套2206从而其不再约束附连构件时，由于支架瓣膜的自展开性质，支架瓣膜可以从支架固定器2222上自动分离。当外护套2206完全地包围支架瓣膜(2212，2214)时，声称输送系统2200处于闭合位置中(图22A和22B)，从而使得支架瓣膜不会发生展开。
当(例如)朝向握柄杯2228而部分地推动推柄2210时，声称输送系统2200处于部分打开位置中。在这个特定的打开位置中，支架瓣膜(2212，2214)在近侧部署，且其仍然通过附连元件在远侧附连到支架固定器2222上。这允许支架的精确植入/定位。例如，支架瓣膜可以接近于预期的植入部位部分地释放，并可以在远侧稍微推动，直到感觉到阻力。支架瓣膜(2212，2214)的最终释放可以通过朝向握柄杯2228完全地推动推柄使得输送系统2200到达打开位置来发生。图28B中说明了这种部分打开位置。在某些实施例中，成像机构可用于确定支架是否正确地定位在植入部位处。例如，可以用血管造影术、血管内超声显像(IVUS)、心腔内超声心动图(ICE)、经食管超声心动图(TEE)或其它机构或其组合来实现荧光透视法下的图构，通过该图够成像机构可以至少部分地与输送系统成一体或与其分离。
当植入支架瓣膜(2212，2214)时，输送系统2200可以在从患者体内取回之前(例如)通过保持第一组件和在远侧将第二组件朝尖端2202/外护套2206推动来回复到闭合位置。在其它实施例中，用于释放支架瓣膜的柄可包括用于将柄的旋转运动转换成外护套的平移运动的螺杆机构。这种类型的释放系统可允许逐步地、更精确地释放和重获支架，以及减小外科医生感觉到的释放力。
图23A-23D显示了根据本发明的一个实施例的输送系统2300的另一个实例。除了输送系统2300可以另外地包括一个或多个折叠球囊2302(如近侧于支架瓣膜)之外，输送系统2300可与输送系统2200(图22)基本上相似(如图23A和23B的闭合位置；图23C的打开位置)。除非以另外的方式指明，图23A-23D中的相同特征对应于图22A-22D中的相同参考标号，但是没有在图23A-23D中复制参考标号，以避免使附图过于复杂。这同样适用于图24A-D、图25A-C和图26A-C所示的支架输送系统。球囊2302可以通过近侧外轴2304中的另外的内腔膨胀/瘪缩，(例如)以使支架瓣膜(如非自展开支架瓣膜)在植入部位处锚定就位。图23D显示了图23C所示的内腔结构的“A-A”截面图。内腔结构包括5个内腔管2306和内轴2308。在其它实施例中，可以使用用于内腔管2306的其它结构(如双内腔管，其中第二内腔用于球囊膨胀和瘪缩)。输送系统2300还可包括用于球囊膨胀/瘪缩的进入机构2310，其可允许连接注射器或膨胀装置来膨胀/瘪缩球囊。或者或另外，具有附连的旋塞的管可以连接到进入机构2310上。
图24A-24D显示了根据本发明的一个实施例的输送系统2400的另一个实例。在输送系统2400中，近侧外轴2402与近侧外轴2220的直径(图22)相比可具有增大的直径。当在没有引入器的情况下使用输送系统时，增大的直径可以减少流血。或者，当使用了引入器时，增大的直径可与引入器的内径相匹配，该内径又可取决于外护套的外径。在引入器和输送系统之间没有间隙可以减小由于带走的血液引起的潜在的通过引入器取回输送系统的问题的风险。因此，输送系统2400可包括填满内部组件和外部组件之间的间隙的浮动管2404，由此减小内部组件在压缩下扭转的风险，这种风险将导致支架重获过程中输送系统内的更高摩擦力。输送系统2400可在所有其它方面(如图24A和24B的闭合位置；图24C的打开位置)与输送系统2200基本相似。
图25A-C显示了根据本发明的一个实施例的输送系统2500的另一个实例。输送系统2500可包括在支架瓣膜远侧的一个或多个球囊2536。在支架瓣膜远侧具有球囊避免了必须将输送系统引入身体更深处(如引入上升的主动脉中)以便执行膨胀，从而减小对身体的损害的风险，并改进装置处理(如在主动脉弓上没有刚性装置的弯曲)。球囊2536可用于(例如)在支架瓣膜植入和/或已植入的支架瓣膜的后期膨胀之前的瓣膜成形，以改进支架的锚定。图25B和25C分别显示了球囊2536处于闭合位置和打开位置。
输送系统2500的第一组件可包括尖端2502、内球囊轴2504、外护套2506和浮动管2508。第二组件可包括内轴(远侧)2510、支架固定器转接件2512、支架固定器2514、套管2516、渐缩转换轴连接件2518和外轴(近侧)2520。柄组件可包括握柄连接件2522、握柄杯2524、O型圈2526、金属轴2528和推柄2530。球囊组件可包括外轴2532、内轴2534、球囊2536和Y形连接件2538。
图26A-C显示了根据本发明的一个实施例的输送系统2600的另一个实例。输送系统2600可包括集成式引入器2602，其可以是容纳第二组件的另外的组件。输送系统的外护套被示为2604。引入器2602可包括连接线2606、旋塞2608和用于密封薄膜2612的壳体2610。旋塞2608可以用作用于(例如)包含流体(如盐水)的注射器的进入点。连接线2606可以用来将流体从注射器中传送到引入器的内腔中，且密封薄膜2612可以密封引入器隔离外部环境。当植入支架瓣膜时，除了引入器2606以外，输送系统2600的构件(如第一组件和第二组件)可以通过引入器取回。然后，可以通过引入器2602引入另一个医疗装置，诸如，例如闭合装置。作为另一个实例，可以通过引入器2602引入血管内超声显像(IVUS)设备(如微型探针)。输送系统2600可在所有其它方面与输送系统2200基本相似。
图27是根据本发明的某些实施例的涉及置换失效的(如自体或人造)瓣膜的说明性阶段的流程图2700。图28A-28C说明了(不限制)图27的流程图参照的各个阶段。在阶段2702处，支架瓣膜(如单支架瓣膜或双支架瓣膜)可以可移除地附连到输送系统。例如，支架构件的一个或多个附连元件(如图8B的附连元件808)可以固定到输送装置的支架固定器上(如图22的支架固定器2222)。收缩元件(如图22的外护套2206)可以设置在附连元件/支架固定器上，以使支架瓣膜保持收缩构造并附连到输送系统上。
在阶段2704处，支架瓣膜可以以收缩构造输送到植入部位。例如，图28A(“引入”和“定位”)显示了支架瓣膜2802在仍通过支架固定器2804附连到输送系统上且完全地包含在外护套2806内的同时，可沿着导引线而引入到患者体内，从而输送系统的尖端2810穿过失效的瓣膜2812。可以操纵输送系统向前和/或向后，例如，直到确信正确地定位了支架瓣膜。
在阶段2706处，支架瓣膜可以部分地展开，(例如)以确定(阶段2708)是否确实正确地定位了支架瓣膜，以及/或测试(阶段2710)支架瓣膜是否正确地运行。例如，图28A(“部分释放”)显示了外护套2806可以从支架瓣膜的近侧部分2814上部分地移除，同时支架瓣膜的附连元件2816仍然被外护套2806约束在支架固定器2804上。
在阶段2712处，当支架瓣膜在植入部位处正确地定位时，以及/或当支架瓣膜正确地运行时，支架瓣膜可以从输送系统上分离，以便使支架瓣膜扩展成其完全展开构造。例如，图28C(“最终释放”)显示了当从外护套2806内移除了附连元件2816和支架固定器2804时，支架瓣膜2802的附连元件2816可以从支架固定器2804上自动地(或在其它实施例中响应于球囊膨胀)分离，从而使支架瓣膜扩展成其完全展开构造。然后，输送装置的第二组件可与第一组件/外护套重新结合且从患者体内移除。例如，图28C(“输送装置取回”)显示了第二组件2818可以朝向支架瓣膜的远侧穿过置换支架瓣膜2802。然后，重新结合的第二组件2818和第一组件/外护套2806可以在退出患者身体之前沿近侧方向再次穿过支架瓣膜2802。
当支架瓣膜没有正确地定位时(阶段2708)，在阶段2714处，支架瓣膜可以回复到收缩构造，并在患者体内重新定位。图28B中说明了这种情况的说明(“支架重获/重新定位”)，其中，外护套2806沿近侧方向滑到支架瓣膜的近端部分2814上，以便重获支架瓣膜。然后，重新定位和释放支架瓣膜，从而支架瓣膜的固定元件2820接收失效的瓣膜的环面2822。类似地，当支架瓣膜响应于测试(阶段2710)而出故障时，在阶段2716处，支架瓣膜可以回复到收缩构造并从患者体内移除。
因此可以看到，提供了支架瓣膜(如单支架瓣膜和双支架瓣膜)和用于手术的相关方法及系统。虽然本文已经详细描述了特定实施例，但是这是以仅用于说明目的的方式完成的，且不意图限制关于所附的权利要求书的范围。特别地，申请人构思了可以在不偏离权利要求书所限定的本发明的精神和范围的情况下做出各种置换、变更和修改。其它方面、优点和修改应视为处于所附的权利要求书的范围之内。所提出的权利要求书代表了本文所公开的发明。还构思了其它未声明的发明。申请人保留在以后的权利要求书中继续这种发明的权利。

Claims (11)

1.一种用于在人体内使用的置换瓣膜，其包括：
瓣膜构件；和
支架构件，其包括第一部分、用于容纳所述瓣膜构件的第二部分、以及构造成用于可移除地附连到输送装置上的第三部分；
其中，所述第二部分包括多个U形支杆，每个U形支杆具有邻近所述第三部分的封闭端和邻近所述第一部分的敞开端，其中，相应U形支杆的第一臂连接至所述相应U形支杆的第二臂以形成所述封闭端；并且
其中，所述第二部分还包括形成成组的网格单元的网格结构，每组网格单元布置在相应U形支杆的第一臂和第二臂之间。
2.根据权利要求1所述的瓣膜，其特征在于，所述第一部分包括网格结构，其具有比所述第二部分和/或所述第三部分更稠密的网格单元。
3.根据权利要求1所述的瓣膜，其特征在于，相邻的U形支杆之间的区域不具有网格单元。
4.根据权利要求1所述的瓣膜，其特征在于，所述第一部分包括围绕所述支架构件的周边延伸的多个网格单元。
5.根据权利要求1所述的瓣膜，其特征在于，所述第一部分包括围绕所述支架构件的周边延伸的多排网格单元。
6.根据权利要求1所述的瓣膜，其特征在于，所述第三部分包括：
多个附连元件，其构造成用于可移除地附连到输送装置上；和
多个支撑元件，每个支撑元件附连在两个相邻的附连元件之间。
7.根据权利要求6所述的瓣膜，其特征在于，所述支撑元件中的每一个包括大致波形线材。
8.根据权利要求1所述的瓣膜，其特征在于，所述第二部分包括仅仅三个U形支柱。
9.根据权利要求1所述的瓣膜，其特征在于，每组网格单元的网格结构包括具有大致波形部分的至少一个补偿元件。
10.根据权利要求1所述的瓣膜，其特征在于，所述瓣膜构件的接合点分别缝合至所述第二部分中的网格结构。
11.根据权利要求1所述的瓣膜，其特征在于，所述第三部分包括多个附连元件，每个附连元件包括开口，用于可移除地附连到输送装置的补充元件。
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