CN112336498A - 二尖瓣瓣膜组件 - Google Patents

二尖瓣瓣膜组件 Download PDF

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CN112336498A
CN112336498A CN202011148567.5A CN202011148567A CN112336498A CN 112336498 A CN112336498 A CN 112336498A CN 202011148567 A CN202011148567 A CN 202011148567A CN 112336498 A CN112336498 A CN 112336498A
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valve assembly
heart valve
assembly
cells
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CN112336498B (zh
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曾敏
P·罗
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Hangzhou Qiming Medical Devices Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • 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
    • 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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
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    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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Abstract

一种心脏瓣膜组件，包括：框架，所述框架包括锚固区段、以及从锚固区段延伸的第一支腿和第二支腿，以及连接至框架的小叶组件，小叶组件包括第一小叶和第二小叶，所述第一小叶和第二小叶中的每一个包括：裙状区段，所述裙状区段包括主体部分，所述主体部分具有相对的两侧边缘、以及由第一缝合边缘限定的开口，以及窦形小叶区段，所述窦形小叶区段具有流出边缘、以及弯曲的第二缝合边缘，其中所述窦形小叶区段沿所述第二缝合边缘缝合至对应的所述主体部分的所述第一缝合边缘，且其中所述第一小叶和所述第二小叶的所述裙状区段和所述窦形小叶区段限定一血流通道，所述血流通道的流出端至少由所述窦形小叶区段的所述流出边缘限定。

Description

二尖瓣瓣膜组件
技术领域
本公开涉及经导管置换二尖瓣瓣膜的方法、系统和设备，以恢复患者的二尖瓣瓣膜功能。
背景技术
多年来一直使用人工心脏瓣膜来治疗心脏瓣膜疾病。原生心脏瓣膜(诸如主动脉瓣膜、肺动脉瓣膜和二尖瓣瓣膜)在确保充足的血液供应通过心血管系统向前流动中起到关键性作用。这些心脏瓣膜会因先天性、炎症性或传染性疾病而变得不太有效。这类疾病最终会导致严重的心血管功能不良或死亡。多年以来，对这类病症的确定性治疗是在心内直视手术期间以外科手术修复或置换瓣膜，但是这类外科手术会带来创伤并且容易引起并发症。
最近，已经开发了使用柔性导管以比心内直视手术的侵入性更低的方式引入和植入人工心脏瓣膜的经血管技术。在这项技术中，人工瓣膜以卷曲状态安装到柔性导管的端部上，并且通过患者的血管前进，直到瓣膜到达植入位置。随后导管尖端处的瓣膜之后诸如通过对安装了所述瓣膜的球囊充气而在有缺陷的原生瓣膜的位置处膨胀至其功能尺寸。可替代地，瓣膜可以具有有弹性的自膨胀式支架或框架，所述支架或框架在所述瓣膜从导管远端处的输送鞘管前进时将瓣膜膨胀至其功能尺寸。
然而，不同于主动脉瓣膜，二尖瓣瓣膜环并未提供良好的界标来定位置换二尖瓣瓣膜。在需要置换主动脉瓣膜的患者体内，主动脉环的高度和宽度在与钙形成相关联的退行性疾病存在的情况下通常会增大。由于主动脉环的横截面积减小，所以组织的这些变化使得能够更容易将置换主动脉瓣膜正确地固定在适当的位置处。然而，在经历反流的二尖瓣瓣膜中并不存在通常发现于主动脉瓣膜的退行性变化，并且二尖瓣瓣膜环因此通常比病变的主动脉瓣膜环更薄。更薄的二尖瓣瓣膜环使得将置换二尖瓣瓣膜正确地安设在原生二尖瓣瓣膜环中变得相对更为困难。二尖瓣瓣膜环的一般解剖结构也使得将置换二尖瓣瓣膜正确地锚固在适当的位置变得更为困难。与主动脉瓣膜环所提供的从主动脉到左心室的过渡相比，二尖瓣瓣膜环提供了从左心房到左心室的更平滑的过渡。主动脉环在解剖结构上更为明显，提供更大的“凸起”，在所述凸起上，置换主动脉瓣膜可以更容易地固定在适当的位置处。
因此，更大的二尖瓣瓣膜环使得难以将当前经皮输送的瓣膜牢固地植入在原生二尖瓣位置中。已经作出一些尝试来通过以下方式输送和植入一件式置换二尖瓣瓣膜：夹紧在环上；或钩挂在腱索上；以及使植入框架膨胀而紧配在环中。这些方法或多或少会改变患者的解剖结构并且会影响主动脉瓣膜的功能和血液流动。
因此，仍然需要一种置换二尖瓣瓣膜，所述置换二尖瓣瓣膜可以通过经皮输送而牢固地植入在原生二尖瓣位置处，而不会使患者的解剖结构变形。
发明内容
本公开提供一种二尖瓣瓣膜组件和相关联的输送系统，其允许以经皮经导管方式将自膨胀支架内的生物瓣膜放置在患者的原生二尖瓣位置处。
本发明提供一种心脏瓣膜组件，包括：框架，所述框架包括锚固区段、以及从锚固区段延伸的第一支腿和第二支腿，以及连接至框架的小叶组件，小叶组件包括第一小叶和第二小叶，所述第一小叶和第二小叶中的每一个包括：裙状区段，所述裙状区段包括主体部分，所述主体部分具有相对的两侧边缘、以及由第一缝合边缘限定的开口，以及窦形小叶区段，所述窦形小叶区段具有流出边缘、以及弯曲的第二缝合边缘，其中所述窦形小叶区段沿所述第二缝合边缘缝合至对应的所述主体部分的所述第一缝合边缘，且其中所述第一小叶和所述第二小叶的所述裙状区段和所述窦形小叶区段限定一血流通道，所述血流通道的流出端至少由所述窦形小叶区段的所述流出边缘限定。
本公开还提供一种用于将心脏瓣膜组件固定在人体心脏的二尖瓣位置中的方法。所述心脏瓣膜组件被输送至原生二尖瓣环的位置，并且锚固区段在左心房内展开，以使得锚固区段被完全保持在左心房中，并且支腿和小叶延伸穿过原生二尖瓣环。
附图说明
图1是根据本发明的一个实施方案的以膨胀配置示出的二尖瓣瓣膜组件的透视侧视图。
图2是图1的组件的侧视图。
图3是图1的组件的俯视图。
图4是图1的组件的框架的透视图。
图5是图4的框架的侧视图。
图6是图1的组件的小叶组件的分解图。
图7A是图6的小叶组件的前视图。
图7B是图6的小叶组件的后视图。
图8是图6的小叶组件的透视图。
图9示出可以用于布置图1的组件的输送系统。
图10A示出图1的组件到患者的心脏的二尖瓣位置的经心尖输送。
图10B示出图1的组件在患者的心脏的二尖瓣位置中的部分展开。
图11A示出图1的组件在人心脏的二尖瓣位置中处于打开位置。
图11B示出图1的组件在人心脏的二尖瓣位置中处于闭合位置。
具体实施方式
以下详细描述是当前所预期的实施本发明的最佳模式。此描述不应视为具有限制性意义，而是仅仅用于说明本发明的实施方案的一般原理的目的。本发明的范围由随附权利要求书进行最佳限定。
本发明提供一种二尖瓣瓣膜组件100，所述二尖瓣瓣膜组件100在图1-8中以完全组装形式示出。组件100具有框架101(参见图4-5)，所述框架101具有简单的瓣叶支撑结构，所述瓣叶支撑结构可以有效地固定在原生二尖瓣瓣膜环处。此外，小叶组件104(图6-8)提供新颖的小叶配置以提供瓣叶的快速打开和闭合，并具有较大的有效开口面积。装置100的整体构造简单，并且可有效提升适当的二尖瓣功能。
如图1-5所示，框架101具有球形锚固区段109，所述球形锚固区段109适于定位在患者心脏的左心房内。两个支腿17和18从锚固区段109的下游端延伸穿过原生二尖瓣环而进入到左心室中。支腿17、18和区段109可以由一根连续的丝构成，并且也可以由薄壁具有生物相容性的金属元件(诸如，不锈钢、Co-Cr基合金、NitinolTM、Ta以及Ti等)构成。作为举例，丝可以由本领域熟知的NitinolTM金属丝构成，并且具有0.2″至0.4″的直径。区段109在框架101内限定开放单元103。每个单元103可以由包围单元103的多个支柱105限定。
锚固区段109用于将组件100(确切地说是框架101)固定或锚固在左心房内。锚固区段109具有由两排环形的单元103限定的大致球形的配置，其中第一排21中的单元103在流入端处具有顶点20，而第二排22中的单元103在流出端处具有顶点8。每排单元103具有环状之字形的支柱布置，所述支柱布置限定峰和谷。术语“球形”意思是指类似于原生左心房的形状的大致球形或椭圆球形形状。因此，锚固区段109被成型为在处于其膨胀或展开配置时具有几分类似球形的球状配置，其中顶点20限定流入端处的环形开口，而顶点8限定流出端处的环形开口。此外，单元103的形状和尺寸在整个区段109中可以改变。例如，单元103被示出为几分菱形形状，并且排21中的单元103通常可以大于排22中的单元103。
支腿17和18从两个相对的单元103延伸。确切地说，支腿17起始于从单元103之一延伸的弯曲部10，沿着直的区段过渡至第二弯曲部11，并且之后沿着另一个直的区段竖直地延伸至尖端或锁定耳部13。类似地，支腿18起始于从相对单元103延伸的弯曲部9，沿着直的区段过渡至第二弯曲部12，并且之后沿着另一个直的区段竖直地延伸至尖端或锁定耳部14。支腿17和18用于支撑和保持以下描述的小叶区段1a和1b。如图1所示，小叶区段1a和1b可以直接缝合至支腿17和18。锁定耳部13和14可以各种形状提供，诸如为环形、T形或方形，以便于使它们匹配在如图9所示的输送系统的耳套2014中。锁定耳部13和14用于将瓣膜组件100固定在递送系统中。
以下是框架101的一些示例性和非限制性尺寸。例如，参考图5，锚固区段109的高度H可以在15-40mm之间；并且锚固区段109在其最宽点处的直径D可以在20-50mm之间。
此外，支腿17和18的长度可以根据其中支撑的小叶区段1a、1b的数目而变化。例如，在提供了双小叶区段1a、1b的图1-8所示的实施方案中，支腿17、18的长度可以为大约10-30mm。如果提供四个小叶区段1a、1b，那么支腿17、18的长度可以更短，诸如10-20mm。这些示例性尺寸可以用于适于用在一般成人的原生二尖瓣位置处的组件100。
参考图6-8，本发明提供一种新颖的小叶组件104，所述小叶组件104提供了小叶之间的更好的接合。此小叶组件104可以与2015年1月13日提交的序列号14/595,433中所示和所述的小叶组件相同，所述申请的全部公开内容以引用的方式并入本文，就像本文全面阐述一样。
小叶组件104提供两个单独的小叶，所述小叶中的每一个包括上部裙状区段1a或1b，以及下部窦形小叶区段2a或2b。换言之，区段1a和2a构成一个小叶，并且区段1b和2b构成另一个小叶。如图6、图7A和图7B最佳所示，裙状区段1a和1b是相同的，并且每一个具有大半径的半椭圆形凸缘部分6a或6b，以及小半径的主体部分4a或4b。每个主体部分4a或4b具有相对的侧边缘26a，所述侧边缘26a用作接合折线，沿着所述接合折线，可以缝合侧边缘26a以将两个单独的小叶组装成单个小叶组件104。每个主体部分4a或4b还具有由缝合边缘29限定的中心U形开口，所述中心U形开口适于接纳对应的窦形小叶区段2a或2b的弯曲边缘。每个裙状区段1a、1b在原生环的顶部上产生椭圆形形状的部位。
每个窦形小叶区段2a或2b具有大致半圆形的形状，包括流出边缘3a或3b，以及由缝合边缘31限定的弯曲边缘。每个窦形小叶区段2a或2b沿着其缝合边缘31缝合至对应的主体部分4a或4b的缝合边缘29。
小叶材料可以是处理过的动物组织诸如心包，或来自生物相容聚合物材料(诸如，PTFE、涤纶、牛、猪等)。小叶区段1a、1b、2a和2b还可以设有药物或生物试剂涂层以提高性能，防止血栓形成并促进内皮化，并且也可以进行处理(或者提供)以具有表面层/涂层以防止钙化。
本发明的组件100可以压缩成小外形并装载到输送系统中，并且之后通过非侵入性医疗手术，诸如通过在经心尖、或经股骨、或经中隔手术中使用输送导管而输送至目标位置。一旦组件100到达目标植入位置，就可以从输送系统释放，并且可以通过对球囊充气(针对球囊可膨胀框架101)或者通过存储在框架101中的弹性能量(针对框架101由可自膨胀材料制成的装置)来使所述组件膨胀至其正常(膨胀)外形。
图9-11B示出可以如何使用经心尖输送将组件100布置在患者的心脏的肺动脉干处。现参考图9，输送系统包括输送导管，所述输送导管具有外轴2013，以及内芯2012，所述内芯2012延伸穿过外轴2013的管腔。耳套2011从内芯2012延伸，并且耳套2011还连接至远端尖端2015。在耳套2011上，存在与锁定耳部13、14(图1-5)匹配的耳部2014。封壳2010连接至外轴2013的远端并从所述远端延伸，并且适于环绕和封装组件100。轴从支腿17和18延伸穿过组件100的内部管腔而到达远端尖端2015。使装置100卷曲并将其装载在内芯2012上，并且之后将所述装置压缩至耳套2011上的耳部2014，其中锁定耳部13、14(图1-5)被锁定在耳部2014(图9)中。锁定的组件100和耳套2011之后由封壳2010覆盖。
现参考图10A，组件100以折叠配置示出于封壳2010中，并且经由经心尖输送技术而输送至二尖瓣位置。在图10B中，封壳2010被部分撤回以部分暴露组件100，以使得自膨胀框架101会将锚固区段109布置在左心房中。如图10B所示，锚固区段109被成型来使得其符合于原生左心房的形状和配置，从而允许锚固区段109以一种方式安设在左心房内，以使得锚固区段109可将整个组件100保持处于略微固定的位置，而不需要使用钩子、倒刺或其他组织穿刺机构。
当封壳2010被完全撤回时，如图11A和图11B所示，支腿17和18延伸穿过原生环，其中锚固区段109整体定位在左心房内。小叶区段1a、1b也延伸穿过原生二尖瓣环。图11A示出小叶组件100处于打开位置，并且图11B示出小叶组件100处于闭合位置。如这些图所示，组件100允许原生小叶以正常方式工作，其中小叶区段1a、1b用于对原生小叶的有缺陷的功能(例如，二尖瓣反流—泄漏的二尖瓣瓣膜)进行补偿。
因此，当组件100展开并与原生二尖瓣瓣膜对准时，锚固区段109的球形配置允许大部分组件100保持在左心房10内，并且小叶区段1a、1b牢固地定位在二尖瓣环内的一个位置处，在此位置上，所述小叶区段挤进或推开原生小叶，而不需要使用任何钩子或倒刺或其他类似的固定机构。小叶区段1a、1b发挥作用来对原生有缺陷的泄漏的二尖瓣瓣膜进行补偿，从而一起作用来形成“密封件”，进而防止泄漏或回流(即，血流从左心室回到左心房)。
本发明的组件100提供许多益处。第一，锚固区段109保持在左心房内的方式提供了有效固定，而不需要使用倒刺或钩子或其他侵入性固定机构。所述固定是有效的，因为它使得组件100的上下迁移最小化。第二，锚固区段109的配置允许组件100适于具有不同尺寸和形状的左心房，从而通过允许每个型号或尺寸的组件100用于更大范围的患者来减少定尺寸和成型问题。第三，此组件100因不会使环膨胀或影响主动脉瓣膜功能而实现了患者的解剖结构的最小改变。左心室中的锚固区段109具有简单的结构，而不会改变原生腱索或瓣膜，最小化了对血液动力学的影响。
虽然以上描述涉及本发明的特定实施方案，但是将理解，可以在不脱离其精神的情况下进行许多修改。随附权利要求旨在于覆盖将落入本发明的真实范围和精神之内的这类修改。

Claims (12)

1.一种心脏瓣膜组件(100)，包括：
框架(101)，所述框架(101)包括锚固区段(109)、以及从所述锚固区段(109)延伸的第一支腿(17)和第二支腿(18)，以及
连接至所述框架(101)的小叶组件(104)，所述小叶组件(104)包括第一小叶和第二小叶，其特征在于，所述第一小叶和第二小叶中的每一个包括：
裙状区段(1a,1b)，所述裙状区段(1a,1b)包括主体部分(4a,4b)，所述主体部分(4a,4b)具有相对的两侧边缘、以及由第一缝合边缘(29)限定的开口，以及
窦形小叶区段(2a，2b)，所述窦形小叶区段(2a，2b)具有流出边缘(3a,3b)、以及弯曲的第二缝合边缘(31)，其中
所述窦形小叶区段(2a，2b)沿所述第二缝合边缘(31)缝合至对应的所述主体部分(4a,4b)的所述第一缝合边缘(29)，且
其中所述第一小叶和所述第二小叶的所述裙状区段(1a,1b)和所述窦形小叶区段(2a，2b)限定一血流通道，所述血流通道的流出端至少由所述窦形小叶区段(2a，2b)的所述流出边缘(3a,3b)限定。
2.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述裙状区段(1a,1b)还包括连接至所述主体部分(4a,4b)的凸缘部分(6a，6b)，所述血流通道的流入端由所述裙状区段(1a,1b)的所述凸缘部分(6a，6b)的边缘限定。
3.根据权利要求2所述的心脏瓣膜组件(100)，其特征在于，所述主体部分(4a,4b)的半径小于所述凸缘部分(6a，6b)的半径。
4.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述小叶组件(104)由单独的第一小叶和第二小叶构成，且所述第一小叶的所述主体部分(4a)的所述相对的两侧边缘分别缝合至所述第二小叶的所述主体部分(4b)的相应的侧边缘。
5.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述由第一缝合边缘(29)限定的开口为一所述主体部分(4a,4b)的中心U形开口。
6.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述窦形小叶区段(2a，2b)具有大致半圆形的形状。
7.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述小叶组件(104)缝合至所述第一支腿(17)和所述第二支腿(18)。
8.根据权利要求1至7中任一项所述的心脏瓣膜组件(100)，其特征在于，所述锚固区段(109)由多排单元限定，每排单元具有限定峰和谷的环状之字形布置。
9.根据权利要求8所述的心脏瓣膜组件(100)，其特征在于，所述锚固区段(109)由第一排单元(21)和第二排单元(22)限定，所述第一排单元(21)的环状之字形布置的顶点(20)限定位于流入端的环形的第一开口，所述第二排单元(22)的环状之字形布置的顶点(8)限定位于流出端的环形的第二开口。
10.根据权利要求9所述的心脏瓣膜组件(100)，其特征在于，所述第一排单元(21)中的单元(103)大于所述第二排单元(22)中的单元(103)。
11.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述心脏瓣膜组件(100)为二尖瓣瓣膜组件，所述锚固区段(109)的高度(H)在15-40mm之间，所述锚固区段(109)在其最宽点处的直径(D)在20-50mm之间。
12.根据权利要求1所述的心脏瓣膜组件(100)，其特征在于，所述第一支腿(17)或所述第二支腿(18)的长度为10-30mm或10-20mm。
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