CN110913796B - 经导管心脏瓣膜存储容器和折绉机构 - Google Patents

经导管心脏瓣膜存储容器和折绉机构 Download PDF

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CN110913796B
CN110913796B CN201880047386.8A CN201880047386A CN110913796B CN 110913796 B CN110913796 B CN 110913796B CN 201880047386 A CN201880047386 A CN 201880047386A CN 110913796 B CN110913796 B CN 110913796B
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N·尼尔
C·佩莱
T·萨尔
A·巴拉什
D·迈蒙
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    • A61F2/02—Prostheses implantable into the body
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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
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    • 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
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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
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Abstract

本文公开了用于可扩张假体心脏瓣膜的存储容器，所述存储容器在打开容器并从容器移出瓣膜时使瓣膜折绉。容器包括壳体和折绉机构，壳体被设定大小以接收处于其扩张构型的心脏瓣膜。折绉机构被结合到容器中并接合心脏瓣膜，以便在打开容器并移出瓣膜时，将心脏瓣膜从其扩张构型可操作地转变为其较小的折绉构型。

Description

经导管心脏瓣膜存储容器和折绉机构
相关申请的交叉引用
本申请要求2017年7月18日提交的美国临时申请号62/534,033的权益，其出于所有目的通过引用以其整体进行并入。
技术领域
本发明总体上涉及医学器械，且具体地涉及用于存储和制备植入用可扩张心脏瓣膜假体的容器和方法。
背景技术
假体心脏瓣膜被用于置换损伤或患病的心脏瓣膜。在脊椎动物中，心脏是中空的肌肉器官，具有四个泵腔：左心房和右心房以及左心室和右心室，每个都具有它自己的单向瓣膜。自然心脏瓣膜被识别为主动脉瓣、二尖瓣(mitral或bicuspid)、三尖瓣和肺动脉瓣。假体心脏瓣膜可用于置换任意这些天然存在的瓣膜。
在表明需要置换心脏瓣膜的地方，功能不良的瓣膜一般通过外科手术移出，并用机械瓣膜或组织瓣膜置换。组织瓣膜经常优于机械瓣膜，因为它们一般不需要用抗凝剂的长期治疗。最常见的组织瓣膜用全猪(porcine或pig)瓣膜、或用从牛(bovine或cow)心包膜获得的单独的小叶进行构造。尽管可以利用所谓的无支架瓣膜(包括猪主动脉的一部分连同瓣膜一起)，但最广泛使用的瓣膜包括某种形式的支架或合成小叶支持件。一般地，具有交替的弓形尖(cusps)和直立的连合的丝型件结合环形支架和缝合环将小叶支撑在瓣膜内。交替的尖和连合模仿小叶附着的自然轮廓。
常规的心脏瓣膜置换手术涉及通过胸内的纵向切口进入患者胸腔中的心脏。例如，正中胸骨切开术需要切穿胸骨并迫使肋廓(rib cage)的两个相对的两等份扩展开，以允许进入胸腔和心脏内。然后将患者放置于心肺转流术，这涉及停止心脏以准许进入内部腔室。这种直视心外科手术特别具有侵入性，并且涉及漫长且困难的恢复期。
近来，已经进行了大量研究以减少与常规的直视心脏瓣膜置换外科手术相关的创伤和风险。特别是，自1990年代初至中期以来，微创手术(MIS)领域迅猛发展，其中现在可以得到能够在不打开胸腔的情况下进行瓣膜置换的设备。MIS心脏瓣膜置换手术通常仍需要转流术，但是在内窥镜和其它这类可视化技术的帮助下，天然瓣膜的切除和假体瓣膜的植入是经由细长管(导管或插管)完成的。
最近，已经开发了多种假体心脏瓣膜，其中瓣膜结构被安装在支架上，且然后经由经皮导管技术被递送到植入部位。通常仅在植入之前将这种经导管心脏瓣膜(THV)折绉(crimped)至较小的直径或轮廓。
为了将对相对较脆弱的组织类型或生物假体心脏瓣膜的损伤的可能性降到最低，将它们包装在装有杀菌剂和防腐剂溶液的罐中，以便在使用前进行运输和存储。在这样做时，瓣膜被稳定以防止瓣膜接触罐的内部。在植入患者中之前，要从瓣膜上清洗残留的痕量杀菌剂和防腐剂溶液。通过首先从罐移出瓣膜，然后在无菌盐溶液中冲洗瓣膜，来完成清洗。冲洗后，将瓣膜折绉以将其减小至适合经导管递送和植入的大小。如果瓣膜在植入前被操纵时接触任何表面，则这个过程会使瓣膜容易受到损伤。
仍然需要针对这种瓣膜的存储和制备系统，防止对瓣膜的损伤，并使得执业医师能够在植入之前容易且安全地从存储容器中移出瓣膜、制备和折绉瓣膜。
发明内容
本文公开了用于经导管心脏瓣膜的存储容器，所述存储容器允许存储处于其扩张构型的心脏瓣膜，并且准许在植入前在将瓣膜从存储罐中移出时，容易地将心脏瓣膜从较大直径折绉到较小直径。存储容器包括容器壳体和折绉机构。容器壳体被设定大小以接收处于其扩张构型的心脏瓣膜。折绉机构被结合到容器中并接合心脏瓣膜，以在打开容器并移出瓣膜时将心脏瓣膜从其扩张构型转变为其折绉或未扩张构型。
尽管本发明特别地适合与有支架的假体心脏瓣膜一起使用，但它也可以应用于其它类型的支架，如冠状动脉支架、外周支架、其它有支架的心脏瓣膜和支架移植物。
在一些实施方式中，折绉机构包括被耦接至容器壳体的瓣膜盖。瓣膜盖包括与容器壳体的内部连通的中心开口，其中心脏瓣膜通过中心开口的移动将心脏瓣膜从其扩张构型转变为其折绉构型。处于其扩张构型的心脏瓣膜的直径大于处于其折绉构型的直径。
瓣膜盖可包括从底表面延伸到中心开口的锥形通道，其中在打开容器时，心脏瓣膜通过锥形通道的移动将心脏瓣膜从其扩张构型转变为其折绉构型。在一些实施方式中，锥形通道可限定圆锥形通路。瓣膜盖的底表面上的锥形通道的开口大小可以被设计成对应于处于其扩张构型的心脏瓣膜的大小，而通道的另一端对应于处于其折绉构型的瓣膜的大小。
在一些实施方式中，折绉机构进一步包括被耦接至容器壳体的顶盖，顶盖具有与瓣膜盖的中心开口轴向对准的开口。折绉机构进一步包括具有中心腔的基部结构，中心腔被设定大小并被配置以接收心脏瓣膜。基部可相对于瓣膜盖轴向地移动，以使心脏瓣膜移动通过瓣膜盖的中心开口。瓣膜盖可以被固定到容器壳体。并且顶盖可以被可旋转地耦接到容器壳体和瓣膜盖。基部包括用于接合顶盖中的螺纹开口的外螺纹，使得顶盖的旋转导致螺纹开口接合基部的外螺纹并且相对于顶盖轴向地移动基部。
在一些实施方式中，折绉机构进一步包括位于基部的中心腔内的瓣膜台，瓣膜台为心脏瓣膜提供轴向支撑。在其它实施方式中，折绉机构包括邻近心脏瓣膜轴向地延伸并为心脏瓣膜提供径向或侧向支撑的瓣膜支撑件。
本文还公开了用于存储和折绉可扩张的假体心脏瓣膜的系统。系统包括具有折绉和扩张构型的可扩张假体心脏瓣膜，心脏瓣膜包括环形框架，其中小叶结构被定位在框架内。系统还包括容器壳体和折绉机构，所述容器壳体被设定大小以接收处于其扩张构型的心脏瓣膜，所述折绉机构被结合到容器壳体中并接合心脏瓣膜，以在打开容器和移出心脏瓣膜时，可操作地将心脏瓣膜从其扩张构型转变为其折绉构型。心脏瓣膜可以是组织型瓣膜，并且容器壳体可以保持适合于保存小叶结构的溶液。
在一些实施方式中，折绉机构包括：瓣膜盖，其被耦接至容器壳体并且包括与容器壳体的内部连通的中心开口；以及基部，其具有中心腔，中心腔被设定大小并且被配置为接收心脏瓣膜。基部可相对于瓣膜盖轴向地移动，以使心脏瓣膜移动通过瓣膜盖的中心开口。心脏瓣膜被定位在基部的中心腔内，并且心脏瓣膜通过中心开口的移动将心脏瓣膜从其扩张构型转变为其折绉构型。
在一些实施方式中，折绉机构包括可旋转地耦接至瓣膜盖和容器壳体的顶盖，顶盖具有与瓣膜盖的中心开口轴向对准的开口。基部包括用于接合顶盖中的螺纹开口的外螺纹。基部可旋转地耦接到顶盖，并且顶盖的旋转导致螺纹开口接合基部的外螺纹，从而使基部相对于顶盖轴向地移动。
在一些实施方式中，瓣膜盖包括从瓣膜盖的底表面延伸到瓣膜盖的中心开口的锥形通道。底表面上的锥形通道的开口的大小对应于处于其扩张构型的心脏瓣膜的大小，而通道的另一端对应于处于其折绉构型的瓣膜的大小。心脏瓣膜通过锥形通道的移动将心脏瓣膜从其扩张构型转变为其折绉构型。
本文进一步公开了存储和折绉可扩张假体心脏瓣膜的方法。方法包括提供一种假体心脏瓣膜，所述假体心脏瓣膜具有大小被设定为通过导管被递送到植入部位的折绉构型、和大小被设定为与心脏瓣环接合的扩张构型。方法还包括将心脏瓣膜以其扩张构型存储在容器中，并且当它穿过容器中的开口时，将心脏瓣膜从其扩张构型转变为折绉构型。转变步骤进一步包括通过提供在容器中的锥形通道将心脏瓣膜进行压缩。
在一些实施方式中，容器包括容器壳体；瓣膜盖，其被耦接到容器壳体并包括与容器壳体的内部连通的中心开口；以及基部，其具有接收心脏瓣膜的中心腔。基部可旋转地耦接到瓣膜盖并相可对于瓣膜盖和容器壳体轴向地移动。将心脏瓣膜从其扩张构型转变为其折绉构型的步骤进一步包括使基部相对于瓣膜盖轴向地移动，并使心脏瓣膜从基部的中心腔推进并通过瓣膜盖的中心开口。
在一些实施方式中，顶盖可旋转地耦接到瓣膜盖和容器壳体。基部可包括用于接合顶盖中的螺纹开口的外螺纹，其中顶盖中的螺纹开口与瓣膜盖的中心开口轴向地对准。将心脏瓣膜从其扩张构型转变为其折绉构型的步骤进一步包括旋转顶盖，以使得螺纹开口接合基部的外螺纹，并从而使基部相对于顶盖轴向移动。
在一些实施方式中，将心脏瓣膜从其扩张构型转变为其折绉构型的步骤进一步包括利用围绕心脏瓣膜的约束件折绉心脏瓣膜并且将心脏瓣膜维持在其折绉状态。并且方法进一步包括在将约束件围绕瓣膜放置并将瓣膜安装在递送导管上之后，将心脏瓣膜与存储容器分离。
在附图和以下描述中阐述了本公开的一个或多个实施方式的细节。根据说明书和附图以及根据权利要求书，本公开的其它特征、目的和优点将是明显的。
附图说明
图1是经导管心脏瓣膜的实例存储容器的立体图；
图2是图1的存储容器的正视图；
图3是图1的存储容器的俯视图；
图4是图1的存储容器的仰视图；
图5是包括盖子(lid)的图1的存储容器的立体图；
图6是图5的存储容器的正视立体图；
图7是图5的盖子的仰视立体图；
图8是图5的存储容器的正视图；
图9A是图1的存储容器的截面图；
图9B是图1的存储容器的截面图；
图10是实例瓣膜盖的俯视立体图；
图11是图10的瓣膜盖的仰视立体图；
图12是图10的瓣膜盖的正视图；
图13是图10的瓣膜盖的俯视图；
图14是图10的瓣膜盖的仰视图；
图15是图13的瓣膜盖的截面图；
图16是实例基部的正视图；
图17是图16的基部的侧视图；
图18是图16的基部的立体图；
图19是图16的基部的俯视图；
图20是图16的基部的仰视图；
图21是实例下凸缘的立体图；
图22是图21的下凸缘的仰视图；
图23是实例瓣膜台的立体图；
图24是图23的瓣膜台的正视图；
图25是图23的瓣膜台的俯视图；
图26是图25的瓣膜台的截面图；
图27是实例支撑环的立体图；
图28是图27的支撑环的正视图；
图29是图27的支撑环的俯视图；
图30是实例瓣膜支撑件的立体图；
图31是图30的瓣膜支撑件的正视图；
图32是图30的瓣膜支撑件的侧视图；
图33是图30的瓣膜支撑件的俯视图；
图34是实例瓣膜支撑环的立体图；
图35是图34的瓣膜支撑环的正视图；以及
图36是图34的瓣膜支撑环的俯视图。
不同附图中相似的参考符号表明相似的元件。
具体实施方式
本发明构思的某些实例的以下描述不应用于限制权利要求的范围。通过下面的描述，其它实例、特征、方面、实施方式和优点对于本领域技术人员将变得显而易见。如将认识到的，设备和/或方法能够具有其它不同和明显的方面，所有这些都不脱离本发明构思的精神。因此，附图和说明书应被认为本质上是说明性的而不是限制性的。
为了这个描述的目的，本文描述了这个公开的实施方式的某些方面、优点和新颖特征。所描述的方法、系统和装置不应被解释为以任何方式进行限制。相反，本公开单独地和以彼此呈各种组合和子组合的方式针对各种公开的实施方式的所有新颖的和非显而易见的特征和方面。所公开的方法、系统和设备不限于任何具体方面、特征或它们的组合，所公开的方法、系统和装置也不要求存在任何一个或多个具体优点或待解决的问题。
除非与其相矛盾，结合发明的特定方面、实施方式或实例描述的特征、整数、特性、化合物、化学部分或基团应理解为适用于本文描述的任何其它方面、实施方式或实例。除了组合中至少有一些这样的特征和/或步骤是互斥的之外，在这个说明书(包括任何所附权利要求、摘要和附图)中公开的所有特性、和/或如此公开的任何方法或工艺的所有步骤可以以任何组合进行组合。发明不限于任何前述实施方式的细节。发明延伸至这个说明书(包括任何所附权利要求、摘要和附图)中公开的特征的任何新颖的一个、或任何新颖的组合，或者延伸到如此公开的任何方法或工艺的步骤的任何新颖的一个、或任何新颖的组合。
应当理解，被认为通过引用并入本文的任何专利、出版物或其它公开材料的全部或部分，仅在所并入的材料不与这个公开中阐述的现有定义、陈述、或其它公开材料冲突的程度上并入本文。这样，在必要的程度上，本发 明确阐述的本公开取代了通过引用并入本文的任何冲突材料。被认为通过引用并入本文但与本文阐述的现有定义、陈述或其它公开材料相冲突的任何材料或其部分，仅在所并入的材料和现有公开材料之间没有出现冲突的程度上并入。
如说明书和所附权利要求书中所使用的，除非上下文另外明确指示，单数形式的“一”、“一个”和“该”包括复数指示物。范围在本文中可以表示为从“约”一个特定值和/或到“约”另一特定值。当表示这样的范围时，另一方面包括从一个特定值和/或至另一特定值。类似地，当通过使用先行词“约”将值表示为近似值时，将理解的是，特定值形成另一方面。还将进一步理解的是，范围中每个的端点无论是与另一个端点相关还是独立于另一个端点都是有意义的。
“任选的”或“任选地”意指随后描述的事件或情况可能发生或可能不会发生，以及描述包括所述事件或情况发生的例子和不发生的例子。
贯穿这个说明书的描述和权利要求书，单词“包含(comprise)”及该单词的变体，如“包含(comprising和comprises)”，意指“包括但不限于”，并且不意图排除例如其它添加物、部件、整数或步骤。“示例性的”意指“……的实例”，并不意图传达对优选或理想方面的指示。“诸如”不是限制性的，而是用于解释的目的。
本文使用的术语“近侧的”和“远侧的”是指鞘、导管或递送组合件的区域。“近侧的”意指最靠近设备的手柄的区域，而“远侧的”意指最远离设备的手柄的区域。
如本文所使用的术语“管”或“管状的”并不意指将形状限制为圆形横截面。取而代之的是，管或管状的可以指具有封闭横截面和轴向延伸穿过其中的腔的任何细长的结构。管还可以具有一些选择性位于其中的狭缝或开口——尽管它仍将提供足够的封闭结构以在其腔(一个或多个)内含有其它部件。
本文公开的实施方式提供了用于经导管心脏瓣膜的存储容器，其还促进用于瓣膜的递送和植入的制备。经导管心脏瓣膜有多种设计，包括直接径向地可扩张的类型(如球囊可扩张瓣膜)、自扩张瓣膜、机械可扩张瓣膜、以及所谓的“卷式(rolled)”心脏瓣膜，这些心脏瓣膜螺旋卷绕成紧凑的构型，其可以通过展开进行扩张。尽管本文中展示了球囊可扩张心脏瓣膜，但是应当理解，本文公开的原理适用于所有类型的可扩张心脏瓣膜、支架和类似的医学设备。
本公开涉及用于在植入前存储、制备和处理可扩张假体心脏瓣膜的容器。众多经导管心脏瓣膜包括通常由动物组织或其它生物相容性的天然或合成材料制成的挠性小叶。示例的实施方式展示了具有牛心包小叶的可扩张假体心脏瓣膜。此心脏瓣膜类似于标题为“假体心脏瓣膜”的美国专利号9,393,110中示出和描述的心脏瓣膜，其被专门通过引用并入本文。不管挠性小叶的材料如何，以松弛状态存储它们以最小化小叶的折叠或压缩都是有利的。然而，为了递送这种可扩张心脏瓣膜，使瓣膜的整体轮廓更小(即，折绉的)，以便穿过相对小直径递送导管，因此需要小叶的折叠或压缩。
本公开的容器使得处于其扩张构型的心脏瓣膜的存储成为可能，以在潜在长的存储时间内更好地保护挠性小叶，并且在植入前在从存储罐中移出时，准许容易地将心脏瓣膜进行折绉。
图1示例了用于假体心脏瓣膜105的实例存储容器100的组装图，瓣膜具有扩张和未扩张构型。图2提供了存储容器100的正视图，以及图3和图4分别提供了附视图和仰视图。如图所示，存储容器100包括容器壳体110和顶盖130，容器壳体110被设定大小以接收处于其扩张构型的心脏瓣膜105(如图9A和9B中所示)。
存储容器100包括可移除的盖子190，以防止心脏瓣膜105和其它存储容器100的部件受到污染。图5、6和8示例了图1的存储容器100，其中盖子190被耦接至顶盖130。盖子190被设定大小并且被配置为可移除地按压配合(干涉配合)到顶盖130的螺纹开口 132中。图7提供了盖子190的仰视立体图，其示例了从盖子190的底部突出的凸起环形表面191，用于接合存储容器100的顶盖130的螺纹开口132。还考虑到，可以使用卡扣配合(snap fit)、螺纹连接或使用本领域已知的任何其它可逆紧固件将盖子190耦接至顶盖130。存储容器100可用于存储需要在液体杀菌剂/防腐剂中湿储存的具有小叶的生物假体心脏瓣膜。因此，当将盖子190被耦接至顶盖130时，存储容器100期望地是防漏的。存储容器100的各种部件可以由多种耐腐蚀材料制成，优选模塑聚合物。
如下面将更详细描述的，折绉机构120被结合到容器100中。折绉机构120接合心脏瓣膜105，并且在打开容器和将瓣膜从容器100中移出时，可操作地将心脏瓣膜105从处于其扩张构型的较大直径转变为处于其折绉构型的较小直径。图9A和9B提供了沿图3 中示例的剖面线截取的图1的存储容器100的横截面图。图9A和9B示例了折绉机构120 的各种部件，包括顶盖130、基部140、瓣膜盖150、瓣膜台160和瓣膜支撑件170。
图10至图14提供了实例瓣膜盖150的各种视图。图15提供了沿图13中示例的剖面线截取的瓣膜盖150的横截面。瓣膜盖150包括与容器壳体110的内部连通的中心开口152。如将在下面更详细地描述的，随着心脏瓣膜105被推动通过瓣膜盖150并从中心开口152 中推出，它从其较大的扩张构型转变至其较小的未扩张/折绉构型。中心开口152的直径对应于处于折绉构型的心脏瓣膜105的直径。如图15中示例的，瓣膜盖150包括从瓣膜盖 150的底表面156上的底部开口158延伸到中心开口152的锥形通道154。锥形通道154 可限定圆锥形通路。锥形通道154还可包括邻近中心开口152的圆柱形部分155。圆柱形部分155可以帮助将心脏瓣膜105保持在其折绉构型和稳固位置以附接到递送设备。设置在瓣膜盖150的底表面156上的开口158的尺寸/直径被设定大小并且被配置为对应于处于扩张构型的心脏瓣膜105的尺寸/直径。开口158也可以具有大于处于扩张构型的心脏瓣膜 105的尺寸/直径的尺寸/直径。
如图11、12和15中示例的，瓣膜盖150的底表面156包括圆柱形的突出部159。如图9A和9B中提供的，这个突出部159被设定大小以延伸到瓣膜盖150中并帮助瓣膜盖 150相对于容器壳体110进行定位。
瓣膜盖150可以被固定地连接到容器壳体110，使得瓣膜盖150不能相对于容器壳体 110轴向地和/或旋转地移动。例如，瓣膜盖150可以通过围绕瓣膜盖150的圆周定位的多个螺钉耦接至容器壳体110。考虑到，可以利用任何合适的已知紧固件将瓣膜盖150耦接至容器壳体110。如将在下面更详细地描述的，在瓣膜盖150被固定到容器壳体110的情况下，顶盖130的旋转允许(由基部140支撑的)心脏瓣膜105在存储容器100内轴向地移动并最终通过开口152移出。同样地，在从容器中移出时，心脏瓣膜105从其较大的扩张构型转变为其较小的折绉构型。
图16至图20提供了实例基部140的各种视图。如图9A和9B中示例的，基部140 包括大小被设定以接收心脏瓣膜105的中心腔143。基部140可相对于瓣膜盖150和顶盖 130轴向地移动，以将心脏瓣膜105移动通过瓣膜盖150的中心开口152。
基部140包括用于与顶盖130配合以促进基部140的轴向移动的接合部件。例如，如图9B中示例的，顶盖130包括与瓣膜盖150的开口152轴向对准的螺纹开口132。基部 140可包括外螺纹142以与顶盖130的螺纹开口132可旋转地耦接。
如图9B中示例的，基部140的一部分延伸通过瓣膜盖150，以与顶盖130的螺纹开口132螺纹(threadingly)接合。例如，如图16中提供的，外螺纹142被设置在基部140的一个或多个臂144上。臂144从基部140的通常水平端面145向上延伸。在组装中，臂144 延伸通过设置在瓣膜盖150中的开口151(图13中所示的)，以接合顶盖130的螺纹开口 132。在实例存储容器100中，臂144被设定大小并且被配置为自由移动通过瓣膜盖150 中的开口151，并且在基部140的轴向移动期间不与瓣膜盖150接合或接触。瓣膜盖150 的图13和图14示例了实例弓形开口151，以为基部140的臂144的全程移动提供空间。
存储容器100包括用于轴向地固定容器壳体110的下凸缘134、瓣膜盖150、和顶盖130。图21和22分别提供了下凸缘134的立体图和俯视图。如图9A和图9B中提供的，下凸缘134被耦接到顶盖130的底表面136，使得轴向地和旋转地将下凸缘134相对于顶盖130进行固定连接。下凸缘134可以通过围绕下凸缘134的圆周定位的多个螺钉耦接到顶盖130。考虑到，可以利用本领域中已知的任何合适的紧固件将下凸缘143耦接至顶盖 130。设置在下凸缘134上的凹肩138可被设定大小以在下凸缘134与容器壳体110和瓣膜盖150之间提供间隙或空间139。包含此间隙/空间139允许顶盖130和下凸缘143独立于容器壳体110和瓣膜盖150旋转(容器壳体110被固定地连接至瓣膜盖150)。
图23至图25提供了实例瓣膜台160的各种视图。图26是沿着图25中示例的剖面线截取的瓣膜台160的横截面图。瓣膜台160位于基部140的中心腔143内。心脏瓣膜105 被定位在瓣膜台160上，使得瓣膜台160为心脏瓣膜105提供轴向支撑。瓣膜台160可包括从瓣膜台160的基部结构166向上延伸的多个臂162。如图23和图25中示例的，臂162 可围绕瓣膜台160的圆周等距间隔。臂162的顶表面164为心脏瓣膜105提供支撑表面。臂162可以径向地移动。也就是说，臂162的端部可朝向瓣膜台160的纵向轴线径向地移动，从而导致在臂162的端部近侧的瓣膜台160的径向压缩。臂162被固定到基部结构166，但是可以在臂162和基部结构166之间的交接处提供挠曲特征(如图26中示例的切口161)。臂162也可以由挠性材料构造，以允许它们在压缩力(即，当瓣膜台160与基部140一起轴向地移动时由锥形通道154施加的力)下挠曲。这允许在心脏瓣膜105的折绉期间随着其被推入锥形通道154，臂162和瓣膜台160的远端稍微收缩。还考虑到，瓣膜台160可用于限制基部140的轴向移动并帮助推动心脏瓣膜105通过锥形通道154。例如，当瓣膜臂162和锥形通道154之间的接触导致臂162径向向内移动时，臂162将到达最终压缩点，从而防止瓣膜台160和基部140的任何进一步的轴向移动。如图23和25中示例的，臂162 可限定楔形的横截面。此楔形允许臂162压缩直到楔形臂162的邻近侧壁163A和163B接触。臂162还可包括沿臂162的长度的弯曲部165。此弯曲部165提供了臂162的进一步压缩/径向运动。
图27至图29提供了实例支撑环180的各种视图。如图9A和9B中示例的，折绉机构120可包括定位在瓣膜台160的顶表面164处的支撑环180。支撑环180帮助将心脏瓣膜 105定位在瓣膜台160上和锥形通道154内。如图27和28中示例的，支撑环180包括锥形边缘182，锥形边缘182为心脏瓣膜105提供接触点，并使心脏瓣膜105在支撑环180 上居中。
图30至图33提供了实例瓣膜支撑件170的各种视图。如图9A中示例的，折绉机构120包括邻近心脏瓣膜105轴向延伸的瓣膜支撑件170。在基部140的轴向运动和/或心脏瓣膜105的折绉期间，瓣膜支撑件170可以为心脏瓣膜105提供径向和/或侧向支撑。瓣膜支撑件170可包括从基部结构174延伸的轴向延伸的臂172。臂172可以限定弯曲的内表面176，弯曲的内表面176的大小和形状对应于心脏瓣膜105的外表面。
在心脏瓣膜105的折绉期间，瓣膜支撑件170保持轴向固定在容器壳体110内。即，随着基部140朝向/远离顶盖130地轴向移动，瓣膜支撑件170的臂172延伸/穿过设置在基部140中的开口146。在实例存储容器100中，臂172被设定大小并且被配置为可自由移动通过基部140中的开口146。图18至图20示例了弓形开口146，以为臂172的全程通过提供空间。如图9A中示例的，基部结构174位于基部140下方，并位于基部140与容器壳体110之间。
图34至图36提供了实例上瓣膜支撑环185的各种视图。如图9A和图9B中示例的，折绉机构120包括上瓣膜支撑环185，上瓣膜支撑环185被定位在瓣膜盖150的下表面156、靠近锥形通道154的开口158处。如图30和图31中所示，瓣膜支撑件170的臂172的远端可包括凹表面178，以为上瓣膜支撑环185提供空间。上瓣膜支撑环185可以定位在心脏瓣膜105上方，并且可以被用于将心脏瓣膜105以其扩张构型固定在容器110中。上支撑环185还可以用于将心脏瓣膜105引导到锥形通道154中，并且使(从扩张构型)进入瓣膜盖150并朝向折绉构型的转变变得容易。
如上所述，优选的心脏瓣膜105包括支架主体和多个挠性小叶。如果小叶在存储期间需要保持补水(如，如果它们是由生物假体材料制成的)，则整个容器壳体110被填充有液体杀菌剂/防腐剂溶液。为了便于在植入之前心脏瓣膜105的制备，容器壳体110和/或顶盖130可包括排放孔(未示出)。可替代地，可以从顶盖130上移除盖子190，并且可以通过倾斜或倒置存储容器100来排出不需要的流体。
在心脏瓣膜105的植入前，可以从容器壳体110内排出防腐剂溶液(如果存在)。如果需要，可以在心脏瓣膜105保持在容器壳体110内时移除盖子190并且冲洗心脏瓣膜105，从而减少损伤瓣膜105的机会。然后，可以通过使心脏瓣膜105穿过折绉机构120使心脏瓣膜105进行折绉。使用者在旋转顶盖130的同时可以抓住容器壳体110以将其保持在固定位置。顶盖130的旋转允许基部140的臂144上的外螺纹142接合顶盖130中的螺纹开口132，从而导致基部140的轴向移动。基部140的轴向移动导致心脏瓣膜105朝向并通过瓣膜盖150的锥形通道154的相应轴向移动。当心脏瓣膜105移动通过锥形通道154，并最终通过开口152移出时，由锥形通道154提供的径向压力压缩心脏瓣膜105，并且将心脏瓣膜105从其较大的扩张构型转变为其较小的折绉构型。如果需要，可以在心脏瓣膜 105周围提供约束件以将其维持在折绉构型和/或进一步折绉心脏瓣膜105。然后，心脏瓣膜105可以与存储容器100分离并被安装到递送装置用于植入。
尽管为了清楚和理解的目的，已经通过示例和实例的方式相当详细描述了本公开的前述实施方式，但是对于本领域技术人员明显的是，可以在本公开的精神和范围内进行某些改变和更改。意指在本文公开的本发明的范围不应由上面描述的特定公开的实施方式限制，而应仅由对所附权利要求的公正阅读来确定。

Claims (19)

1.一种用于假体心脏瓣膜的存储容器，其包括：
容器壳体，所述容器壳体被设定大小以接收处于扩张构型的心脏瓣膜；和
折绉机构，所述折绉机构被结合到所述存储容器中并且可操作地接合心脏瓣膜，并将心脏瓣膜从其扩张构型转变为其折绉构型，
其中所述折绉机构包括：
耦接至所述容器壳体的瓣膜盖，所述瓣膜盖包括与所述容器壳体的内部连通的中心开口；
顶盖，所述顶盖被耦接至所述容器壳体并且具有与所述瓣膜盖的所述中心开口轴向对准的开口；
基部，所述基部具有中心腔，所述中心腔被设定大小并被配置以接收心脏瓣膜，所述基部相对于所述瓣膜盖可轴向移动以使心脏瓣膜移动通过所述瓣膜盖的所述中心开口；以及
瓣膜台，所述瓣膜台位于所述基部的中心腔内，所述瓣膜台被配置以为心脏瓣膜提供轴向支撑，其中所述瓣膜台包括从所述瓣膜台的基部结构向上延伸并且固定到所述瓣膜台的基部结构的多个臂，所述臂的顶表面为所述心脏瓣膜提供支撑表面；其中所述臂的端部是可朝向所述瓣膜台的纵向轴线径向地移动的；并且其中挠曲特征被提供在所述臂和所述基部结构之间的交接处，或所述臂由挠性材料构造。
2.权利要求1所述的存储容器，其中心脏瓣膜通过所述中心开口的移动使心脏瓣膜从其扩张构型转变为其折绉构型。
3.权利要求1所述的存储容器，其中所述瓣膜盖包括从底表面延伸到所述中心开口的锥形通道，和
其中心脏瓣膜通过所述锥形通道的移动将心脏瓣膜从其扩张构型转变为其折绉构型。
4.权利要求3所述的存储容器，其中所述锥形通道限定圆锥形通路。
5.权利要求3或4所述的存储容器，其中在所述底表面处的所述锥形通道的开口的大小对应于处于其扩张构型的心脏瓣膜的大小。
6.权利要求1至4中任一项所述的存储容器，其中所述瓣膜盖被固定至所述容器壳体。
7.权利要求1至4中任一项所述的存储容器，其中所述顶盖可旋转地耦接至所述容器壳体和所述瓣膜盖。
8.权利要求1至4中任一项所述的存储容器，其中所述顶盖的所述开口是螺纹开口，
其中所述基部包括用于接合所述顶盖的所述螺纹开口的外螺纹，和
其中所述顶盖的旋转导致所述螺纹开口接合所述基部的所述外螺纹，并使所述基部相对于所述顶盖轴向移动。
9.权利要求1至4中任一项所述的存储容器，其中所述折绉机构进一步包括瓣膜支撑件，所述瓣膜支撑件被配置以邻近心脏瓣膜轴向地延伸并为心脏瓣膜提供径向或侧向支撑。
10.一种用于存储和折绉可扩张假体心脏瓣膜的系统，其包括：
具有折绉和扩张构型的可扩张假体心脏瓣膜，所述心脏瓣膜包括环形框架，其中小叶结构被定位在框架内，
容器壳体，所述容器壳体被设定大小以接收处于其扩张构型的所述心脏瓣膜；
折绉机构，所述折绉机构被结合到所述容器壳体中并与所述心脏瓣膜接合，所述折绉机构可操作地将所述心脏瓣膜从其扩张构型转变为其折绉构型，
其中所述折绉机构包括：
耦接至所述容器壳体的瓣膜盖，所述瓣膜盖包括与所述容器壳体的内部连通的中心开口；
顶盖，所述顶盖被耦接至所述容器壳体并且具有与所述瓣膜盖的所述中心开口轴向对准的开口；
基部，所述基部具有中心腔，所述中心腔被设定大小并被配置以接收心脏瓣膜，所述基部相对于所述瓣膜盖可轴向移动以使心脏瓣膜移动通过所述瓣膜盖的所述中心开口；以及
瓣膜台，所述瓣膜台位于所述基部的中心腔内，所述瓣膜台被配置以为心脏瓣膜提供轴向支撑，其中所述瓣膜台包括从所述瓣膜台的基部结构向上延伸并且固定到所述瓣膜台的基部结构的多个臂，所述臂的顶表面为所述心脏瓣膜提供支撑表面；其中所述臂的端部是可朝向所述瓣膜台的纵向轴线径向地移动的；并且其中挠曲特征被提供在所述臂和所述基部结构之间的交接处，或所述臂由挠性材料构造。
11.权利要求10所述的系统，其中所述容器壳体保持适合于保存所述小叶结构的溶液。
12.权利要求10所述的系统，
其中所述心脏瓣膜被定位在所述基部的所述中心腔内，
其中所述心脏瓣膜通过所述中心开口的移动将所述心脏瓣膜从其扩张构型转变为其折绉构型。
13.权利要求10至12中任一项所述的系统，其中所述顶盖的开口是螺纹开口，
其中所述基部包括用于接合所述顶盖的所述螺纹开口的外螺纹，所述基部可旋转地耦接至所述顶盖，和
其中所述顶盖的旋转导致所述螺纹开口接合所述基部的所述外螺纹，并使所述基部相对于所述顶盖轴向移动。
14.权利要求10至12中任一项所述的系统，其中所述瓣膜盖包括从所述瓣膜盖的底表面延伸到所述瓣膜盖的所述中心开口的锥形通道，和
其中所述心脏瓣膜通过所述锥形通道的移动将所述心脏瓣膜从其扩张构型转变为其折绉构型。
15.存储和折绉可扩张假体心脏瓣膜的方法，所述方法包括：
提供具有折绉构型和扩张构型的假体心脏瓣膜，所述折绉构型被设定大小以通过导管被递送到植入部位，和所述扩张构型被设定大小以接合心脏瓣环；
将所述心脏瓣膜以其扩张构型存储在容器中；和
当所述心脏瓣膜穿过所述容器中的开口时，通过折绉机构将所述心脏瓣膜从其扩张构型转变为其折绉构型，
其中所述容器包括：
容器壳体；
瓣膜盖，所述瓣膜盖被耦接到所述容器壳体并且包括与所述容器壳体的内部连通的中心开口；
基部，所述基部具有用于接收所述心脏瓣膜的中心腔，所述基部可旋转地耦接到所述瓣膜盖并相对于所述瓣膜盖和容器壳体可轴向移动；以及
顶盖，所述顶盖可旋转地耦接到所述瓣膜盖和所述容器壳体，所述顶盖具有与所述瓣膜盖的所述中心开口轴向对准的螺纹开口，
其中所述折绉机构包括瓣膜台，所述瓣膜台位于所述基部的中心腔内，所述瓣膜台被配置以为心脏瓣膜提供轴向支撑，其中所述瓣膜台包括从所述瓣膜台的基部结构向上延伸并且固定到所述瓣膜台的基部结构的多个臂，所述臂的顶表面为所述心脏瓣膜提供支撑表面；其中所述臂的端部是可朝向所述瓣膜台的纵向轴线径向地移动的；并且其中挠曲特征被提供在所述臂和所述基部结构之间的交接处，或所述臂由挠性材料构造。
16.权利要求15所述的方法，
其中转变步骤进一步包括通过提供在所述容器中的锥形通道压缩所述心脏瓣膜。
17.权利要求15或16所述的方法，其中转变步骤进一步包括相对于所述瓣膜盖轴向移动所述基部，以从所述基部的所述中心腔推进所述心脏瓣膜通过所述瓣膜盖的所述中心开口。
18.权利要求15或16所述的方法，其中所述基部包括用于接合所述顶盖的所述螺纹开口的外螺纹，
其中转变步骤进一步包括旋转所述顶盖以使得所述螺纹开口接合所述基部的所述外螺纹，从而使所述基部相对于所述顶盖轴向移动。
19.权利要求15或16所述的方法，其进一步利用围绕所述瓣膜的约束件将所述瓣膜保持在其折绉状态，以及
在将所述约束件围绕所述瓣膜放置并将所述瓣膜安装在递送导管上之后，将所述瓣膜与所述容器分离。
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