CN106456328A - 带有环形活瓣的二尖瓣膜替代品 - Google Patents
带有环形活瓣的二尖瓣膜替代品 Download PDFInfo
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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
- A61F2/2418—Scaffolds therefor, e.g. support stents
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- 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
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0069—Sealing means
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- Cardiology (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
一种假体(10)，其能够经配置以当部署在体腔内时抓取腔内组织，并防止流体围绕假体的外部的轴向流动。所述假体包括经配置以径向展开和收缩从而部署在所述体腔内的可展开框架(20)，以及围绕所述可展开框架的外部定位并固定到所述可展开框架的外部的环形活瓣(50)，所述环形活瓣具有远侧边缘，所述远侧边缘固定在所述框架的远端(14)处或其附近并延伸到固定在所述框架上在近端(12)与远端(14)之间的中间位置处的近侧边缘。所述假体还包括定位在所述可展开框架的内部内的瓣膜主体，其中所述瓣膜主体包括：固定到所述可展开框架(20)的所述内部的内裙部(62)；以及经配置以允许在第一方向上的流动并防止在第二相反方向上的流动的多个叶状结构(64)。在所述框架的所述远端处或其附近在所述环形活瓣与所述瓣膜主体之间界定开口，从而为流体流动到所述环形活瓣与所述瓣膜主体之间的空间(59)中提供通路，并且其中流体流动到所述空间中致使所述环形活瓣从其中所述活瓣更接近所述框架的第一配置移动到其中所述活瓣更远离所述框架隔开的第二配置，从而增加所述假体的表面积并且当所述框架部署在所述体腔内时建立流体在所述框架外部流动的屏障。
Description
相关申请的交叉参考
本申请要求2014年5月19日提交的标题为“具有环形活瓣的二尖瓣膜替代品(REPLACEMENT MITRAL VALVE WITH ANNULAR FLAP)”的美国临时申请No.62/000,309的优先权，所述美国临时申请在此以全文引用的方式并入本文中并视为本说明书的一部分。
技术领域
本文所公开的某些实施例大体上涉及植入腔或体腔内的假体。具体来说，某些实施例涉及经配置以无创伤地抓取腔内组织的可展开假体，例如，用于例如二尖瓣膜的心脏瓣膜替代品。
背景技术
包含主动脉瓣膜、肺动脉瓣膜、二尖瓣膜和三尖瓣膜的人类心脏瓣膜基本上用作与抽动心脏同步地操作的单向瓣膜。所述瓣膜允许血液向下游流动，但是阻止血液向上游流动。不健全的心脏瓣膜呈现瓣膜变窄或回流等损害，这会抑制瓣膜控制血流的能力。此类损害降低了心脏的血液抽动效率，并且会是致衰弱的且危及生命的病症。例如，瓣膜关闭不全会导致心脏肥大和脑室扩张等病症。因此，已经作出了大量的努力来开发用于修复或替代受损的心脏瓣膜的方法和设备。
假体的作用是校正与受损心脏瓣膜相关的问题。例如，机械和基于组织的心脏瓣膜假体能够用来替代受损的原生的心脏瓣膜。最近，已经投入相当大的努力来开发心脏瓣膜替代品，尤其是基于组织的心脏瓣膜替代品，其相比于通过心脏直视手术能够以给患者带来更小创伤的方式进行输送。瓣膜替代品设计为通过微创手术和甚至经皮手术来输送。此类瓣膜替代品通常包含连接到可展开框架的基于组织的瓣膜主体，所述可展开框架接着被输送到原生瓣膜的瓣膜环。
这些瓣膜替代品通常旨在至少部分地阻止血流。然而，当血液在假体外部上围绕瓣膜流动时会产生问题。例如，在心脏瓣膜替代品的情形下，瓣周漏已经证实尤其具有挑战性。另外的挑战涉及此类假体以不会引起创伤的方式相对于腔内组织(例如，任何身体腔或体腔内的组织)固定的能力。当试图将此类假体可控地输送并固定在例如原生二尖瓣膜等位置中时出现进一步挑战。
发明内容
本发明的实施例涉及一种假体，例如但不限于心脏瓣膜替代品。根据一些实施例，一种假体能够经配置以部署在体腔内，并防止流体围绕假体外部的轴向流动。假体能够包含经配置以径向展开和收缩从而部署在体腔内的可展开框架，以及围绕所述可展开框架的外部定位的环形活瓣。进一步实施例涉及输送例如心脏瓣膜替代品等假体的方法，以及使用假体来建立流体在假体外部流动的屏障(例如，从而防止瓣周漏)的方法。
在一些实施例中，假体能够包含可展开框架，所述可展开框架具有近端和远端以及延伸穿过所述可展开框架的纵向轴线。在一些实施例中，框架能够设计为径向展开和收缩从而部署在体腔内。假体能够包含围绕框架外部定位并固定到框架外部的环形活瓣。环形活瓣可以具有远侧边缘，所述远侧边缘固定在框架远端处或其附近，并延伸到固定在框架上在近端与远端之间的中间位置处的近侧边缘。假体能够包含定位在可展开框架内部内的瓣膜主体。在一些实施例中，瓣膜主体能够包含固定到可展开框架内部的内裙部，以及设计为允许在第一方向上的流动并防止在第二相反方向上的流动的多个叶状结构。在一些实施例中，在框架远端处或其附近在环形活瓣与瓣膜主体之间界定开口，所述开口能够为流体流动到环形活瓣与瓣膜主体之间的空间中提供通路。在一些实施例中，流体流动到所述空间中能够使环形活瓣从其中所述活瓣更接近框架的第一配置移动到其中所述活瓣更远离框架隔开的第二配置，从而增加假体的表面积，并当框架部署在体腔内时建立流体在框架外部流动的屏障。
附图说明
图1A是假体的实施例的近侧取向的透视图，示出了框架、多个锚定器、束带、活瓣以及瓣膜主体。
图1B是图1A的假体的远侧取向的透视图。
图2是图1的假体的前正视图。
图3是假体的另一实施例的前正视图。
图4是框架的实施例的前正视图。
图5是环形活瓣的实施例的透视图。
图6是图5的环形活瓣的前正视图。
图7是瓣膜主体的实施例的透视图。
图8是图7的瓣膜主体的前透视图。
图9是假体的实施例的前视图，示出了框架、多个锚定器、束带、活瓣以及瓣膜主体。
图10是假体的另一实施例的前视图。
图11A是图1的假体的部分横截面图，其中环形活瓣处于第一配置。
图11B是图11A的假体的部分横截面图，其中环形活瓣处于第一配置。
图12A是图1的假体的部分横截面图，其中环形活瓣处于第一配置，瓣膜主体被移除。
图12B是图12A的假体的部分横截面图，其中环形活瓣处于第一配置。
图13A到图15示出了图3的假体定位在心脏内的示意性表示，其中图13A到图13C示出了原位的假体，其中远侧锚定器接触二尖瓣膜环的心室侧；图14A到图14B示出了原位的假体，其中远侧锚定器不接触二尖瓣膜环的心室侧；而图15示出了原位的假体，其中远侧锚定器不在腱索之间延伸。
具体实施方式
图1A到图4的实施例示出了假体10。假体10能够具有与美国公开No.2014/0277390、No.2014/0277422和No.2014/0277427中的任一者中描述的那些组件、特征和/或功能类似的组件、特征和/或功能，所有所述美国公开的全部内容以引用的方式并入本文中。首先参考图1A到图4的实施例，假体10能够包含框架20、锚定器30、34、束带40、环形活瓣(annular flap)或帆状物50以及瓣膜主体60。假体10能够包含近端12和远端14，具有在这两端12和14处界定的开口，使得流体能够流动穿过所述开口。在一些实施例中，近端12能够放置在左心房中，而远端14能够放置在左心室中，使得假体10能够用作二尖瓣膜的替代品。如下文将更详细地论述且如美国公开No.2014/0277390、No.2014/0277422和No.2014/0277427中所论述的，假体10能够允许血液在从近端12到远端14的第一方向上流动，同时防止血液在从远端14到近端12的第二方向上流动。例如，在心脏舒张期间，瓣膜主体60可以打开以允许血液从近端12流动到远端14，并且在心脏收缩期间，瓣膜主体60可以关闭以防止血液从远端14流动到近端12。
现在参考图4的实施例，所述实施例示出了假体10的可展开框架20，其能够具有近端22和远端24。在一些实施例中，例如在所示出的实施例中，框架20能够包含中间部分26，当框架20处于展开配置时，所述中间部分26的直径比框架20在近端22和/或远端24处的直径更大。在一些实施例中，例如在所示出的实施例中，框架20能够包含中间部分26，当框架20处于展开配置时，所述中间部分26的横截面积比框架20在近端22和/或远端24处的横截面积更大。框架20能够设计为径向展开和收缩以便于部署在体腔内，例如在心脏瓣膜位置处，例如二尖瓣膜处。例如，如美国公开No.2014/0277390、No.2014/0277422和No.2014/0277427中较详细地描述，框架20能够包含界定多个缩短单元(foreshortening cell)的多个支柱。在一些实施例中，框架20能够设计为从延伸穿过框架20的纵向轴线28径向展开和径向收缩。如图1到图4的实施例中所示，近端22能够界定近侧开口23，而远端24能够界定远侧开口25。
继续参考图1A到图4的实施例，图1A到图4示出了假体10，在一些实施例中，假体10能够包含一个或更多个远侧锚定器30。远侧锚定器30能够沿着或邻近框架20的远端24定位并且能够连接到框架20。远侧锚定器30能够经设计使得当框架20处于展开配置时，每个远侧锚定器30的末端或尖端32从框架20径向向外定位并通常在近侧方向上延伸。在一些实施例中，假体10能够包含一个或更多个近侧锚定器34。近侧锚定器34能够沿着或邻近框架20的近端22定位并且能够连接到框架20。近侧锚定器34能够经设计使得当框架20处于展开配置时，每个近侧锚定器34的末端或尖端36从框架20径向向外定位并通常在远侧方向上延伸。在一些实施例中，一个或更多个锚定器30、34能够包含遮盖此类锚定器中的一个或更多个的缓冲垫38、39。
在一些实施例中，缓冲垫38能够由两片单独的材料形成，例如内部部分定位在遮盖物内，使得遮盖物形成包围所述内部部分的层。例如，内部部分能够完全容纳在遮盖物内。在一些实施例中，内部部分能够由泡沫材料形成，使得内部部分是至少稍微顺应性的，而遮盖物能够由生物兼容性织物材料形成。图1A、图1B和图2的实施例示出了在交替的远侧锚定器30上的缓冲垫38，缓冲垫38部分地从锚定器30的末端或尖端朝向锚定器30与框架20之间的连接部处延伸。当假体10呈收缩状态用于输送时，缓冲垫38在交替的远侧锚定器30上的使用能够维持较小的外观尺寸。因而，对于具有十二个远侧锚定器30的实施例，总共六个远侧锚定器30能够具有缓冲垫38，且总共六个远侧锚定器30可以不具有缓冲垫38。缓冲垫38能够有利地增加锚定器30在组织上的接触面积。这能够减少锚定器30与此类组织之间的创伤。此外，在缓冲垫38由促进组织生长的材料形成的实施例中，这能够有助于组织在锚定器30中和/或周围的生长。在与不具有缓冲垫38的锚定器30相邻的锚定器30上的缓冲垫38还能够有利地减少由相邻的不具有缓冲垫38的锚定器30造成的任何潜在创伤。
图3的实施例示出了在所有远侧锚定器30上的缓冲垫38、39。如图所示，远侧锚定器30中的一些包含比其它远侧锚定器30更厚的缓冲垫38。缓冲垫38、39能够从锚定器30的末端或尖端朝向锚定器30与框架20之间的连接部处延伸锚定器30的大部分长度或整个长度。如图所示，两个远侧锚定器30包含较厚的缓冲垫38，而具有较薄缓冲垫39的远侧锚定器30定位在其间。因而，对于具有十二个远侧锚定器30的实施例，总共八个远侧锚定器30能够具有较厚的缓冲垫38，且总共四个远侧锚定器30能够包含较薄的缓冲垫39。较厚的缓冲垫38能够由内部部分和遮盖层形成，其中内部部分由诸如泡沫等顺应性材料形成，且遮盖物能够由生物兼容性织物材料形成。如图所示，内部部分能够仅围绕锚定器30的一部分定位，而遮盖物能够延伸锚定器30的大部分长度或整个长度。较薄的缓冲垫39能够是具有较薄的内部部分或不具有内部部分的遮盖层。内部部分和/或遮盖物能够由促进组织生长的材料形成。
还能够使用缓冲垫38、39的其它配置。例如，在一些实施例中，缓冲垫38、39能够包含在近侧锚定器34上。在一些实施例中，缓冲垫38、39能够定位在框架20的其它部分上，例如(但不限于)形成框架20的支柱中的一个或更多个。缓冲垫38、39能够有利地增加假体10在组织上的接触面积。这能够减少框架20与此类组织之间的创伤。此外，在缓冲垫38、39由促进组织生长的材料形成的实施例中，这能够有助于组织在框架20中和/或周围的生长。在一些实施例中，缓冲垫38、39的遮盖物能够从环形活瓣50延伸，并由与环形活瓣50的材料类似的材料形成。缓冲垫38、39的遮盖物能够遮盖远侧锚定器30的大部分或全部，如图3中所示。在一些实施例中，缓冲垫38、39能够经由围绕远侧锚定器30的纵向轴线的周向缝合部被附接到远侧锚定器30。
参考图1A到图3的实施例，在一些实施例中，假体10能够包含沿着或邻近框架20的近端22的束带40。束带40能够包含与2012年2月23日提交的标题为“瓣膜替代品和方法(REPLACEMENT VALVE AND METHOD)”的美国专利申请No.13/403,929中描述的特征类似的特征并执行与所述美国专利申请中描述的功能类似的功能，所述美国专利申请被公开为美国公开No.2012/0215303，其全部内容以引用的方式并入本文中。
参考图1A到图3、图5和图6的实施例，假体10能够包含环形活瓣50，其能够围绕框架20的外部定位并固定到框架20的外部。环形活瓣50能够具有远侧边缘52，所述远侧边缘固定在框架20的远端24处或其附近，并延伸到固定在框架20上在近端22与远端24之间的中间位置处(例如，中间部分26)或其附近的近侧边缘54。在一些实施例中，环形活瓣50的远侧边缘52能够具有一般对应于框架20的形状的形状。这能够有助于活瓣50固定到框架20。例如，如图1A到图3、图5和图6的实施例中所示，远侧边缘52能够包含大体上三角形图案56，其遵循框架20的支柱沿着框架20的远端24的大体上三角形、Z形或波形图案。能够沿着环形活瓣50的远侧边缘52使用其它形状和/或图案56。在一些实施例中，环形活瓣50的远侧边缘52能够不具有图案。在一些实施例中，远侧边缘52不遵循框架20的支柱的图案和/或能够具有与支柱的图案不同的图案。
在一些实施例中，例如图1A到图3、图5和图6的实施例中，环形活瓣50能够具有凸缘58。凸缘58能够在大体上与延伸穿过框架20的纵向轴线28正交的方向上大体上径向向外延伸。在一些实施例中，凸缘58还能够向近侧和/或向远侧突出。凸缘58能够用来进一步防止或抑制流体围绕假体10回流。在一些实施例中，凸缘58能够由第一层弹性材料形成，所述第一层弹性材料例如聚对苯二甲酸乙二醇酯(PET)或任何其它生物兼容性材料，其从框架10径向向外延伸。在一些实施例中，第二层弹性材料，例如PET或任何其它生物兼容性材料，能够在远侧方向上从第一层朝向框架20的远端24延伸。在一些实施例中，第一层和第二层能够使用诸如粘合剂或缝合线等合适的机构连接在一起。在一些实施例中，环形活瓣50能够由单层弹性材料形成。在一些实施例中，第一层和/或第二层能够由可变形材料形成。在一些实施例中，第一层和/或第二层能够由完全或基本上为流体不可渗透的材料形成。环形活瓣50还能够包含其它结构，例如诸如由镍钛诺的弹性材料形成的线，从而允许环形活瓣50的至少部分保持特定形状。这些结构可以定位在环形活瓣50的内表面上。
在一些实施例中，凸缘58能够在环形活瓣50处于展开配置时形成。当活瓣处于展开配置时，例如图6的实施例中所示，环形活瓣50的半径能够在凸缘58的远侧减小。如下文将进一步详细描述，环形活瓣50能够具有其中活瓣50更接近框架20的第一折叠或紧缩配置，到其中活瓣50更远离框架20隔开的第二展开或膨胀配置。展开配置能够增加假体10的表面积并当框架20部署在体腔内时建立流体在框架20外部流动的屏障。能够通过到活瓣50的内部区域中的血液流动以及流出活瓣50的内部区域的血液流动触发从第一配置到第二配置的转变以及从第二配置到第一配置的转变，如下文中进一步描述。
参考图1A到图3和图7到图10的实施例，假体10能够包含定位在框架20的内部内的瓣膜主体60。在一些实施例中，瓣膜主体60能够包含固定到框架20的内部的内裙部62。瓣膜主体60能够包含多个叶状结构64，其能够设计为允许在第一方向(例如，近侧到远侧方向)上的流动并防止第二方向(例如，远侧到近侧方向)上的流动。在一些实施例中，叶状结构64具有固定到内裙部62的弯曲的近侧边缘，以及自由移动的远侧边缘。在此类实施例中，远侧边缘朝向和远离彼此的移动能够允许瓣膜主体60取决于流动方向而打开和关闭。因此，瓣膜主体60能够充当单向瓣膜，例如二尖瓣膜。在一些实施例中，叶状结构64固定到内裙部62。叶状结构64和内裙部62能够由相同材料或不同材料制成。例如，内裙部62能够由比叶状结构64更刚性的材料制成。在一些实施例中，内裙部62的远端66能够固定在框架20的远端24处或其附近。在一些实施例中，例如图9和图10的实施例中所示出，内裙部62的远端66能够略微邻近框架20的远端24定位。这能够允许有助于血液围绕内裙部62的外部流动并流到环形活瓣50中。内裙部62能够包含沿着内裙部62的远端66定位的一个或更多个开口或切口67。这能够进一步有助于血液围绕内裙部62的外部流动。在一些实施例中，瓣膜主体60能够包含臂68以进一步将瓣膜主体60固定到框架20。
现在参考图11A到图11B和图12A到图12B的实施例，其示出了环形活瓣的两种配置。应注意，图12A到图12B的实施例与图11A到图11B的实施例类似，其中移除了瓣膜主体60。如图11A和图12A的实施例中所示，在第一配置中，环形活瓣50更接近框架20定位。在流体在第二方向(例如，远侧到近侧方向)上流动的情况下，流体的至少一部分能够进入框架20与环形活瓣50之间的开口(例如，沿着内裙部62的远端66形成的开口或切口67)中，并且聚集在空间59内，使得环形活瓣50采取如图11B和图12B的实施例中所示的第二配置。如图1B的实施例中所示，框架20能够定位在环形活瓣50与瓣膜主体60之间的空间59内。这种效果能够在瓣膜主体60设计为防止在第二方向(例如，远侧到近侧)上的流体流动时得到增强，使得流体的相当大部分被迫围绕环形活瓣50并进入环形活瓣50中。当流体在第一方向(例如，近侧到远侧方向)上流动时，环形活瓣50能够恢复至第一配置，使得流体从空间59内排出。在一些实施例中，能够在内裙部62与活瓣50之间形成空间59。例如，内裙部62和活瓣50两者均能够沿着此区域(例如，沿着活瓣50的近侧边缘54)连接到框架20，使得内裙部62和活瓣50充当流体从空间59向外流动的屏障。
现在参考图13A到图15，其示出了定位在心脏100的原生二尖瓣膜内的心脏瓣膜替代品10的实施例的示意性表示。原生二尖瓣膜的一部分被示意性地示出并表示典型的解剖结构，包含位于瓣膜环106上方的左心房102和位于瓣膜环106下方的左心室104。左心房102和左心室104通过二尖瓣膜环106与彼此连通。图13A到图15中还示意性地示出的是原生二尖瓣叶状结构108，其具有腱索110，所述腱索将二尖瓣叶状结构108的下游末端连接到左心室104的乳头肌。心脏瓣膜替代品10设置在瓣膜环106上游(朝向左心房)的部分能够称为在上方环状地定位。大体上在瓣膜环106内的部分被称为在内部环状地定位。瓣膜环106下游的部分被称为在下方环状地定位(朝向左心室)。在所图示的实施例中，缩短部分的仅一部分在内部环状地或在下方环状地定位，并且心脏瓣膜替代品10的其余部分为在上方环状的。
如图13A到图14中示出的情形中所示，心脏瓣膜替代品10能够经设置使得二尖瓣膜环106在远侧锚定器30与近侧锚定器34之间。在一些情形中，假体10能够经定位使得远侧锚定器30的末端或尖端32接触瓣膜环106，如例如图13A到图13C中所示。在一些情形中，假体10能够经定位使得远侧锚定器30的末端或尖端32不接触瓣膜环106，如例如图14A到图14B中所示。在一些情形中，假体10能够经定位使得远侧锚定器30不围绕叶状结构108延伸，如图15中所示。虽然下文分别描述了图13A到图15，但是应理解，图13A到图15中示出的情形中的一种或更多种可以在假体10位于植入位置(例如，原生二尖瓣膜)处时存在。例如，在一些情形中，假体10可以经定位使得一些远侧锚定器30可以接触瓣膜环106而其它远侧锚定器30可以不接触所述瓣膜环。
首先参考图13A到图14B中示出的情形，心脏瓣膜替代品10能够经定位使得远侧锚定器30的末端或尖端32在二尖瓣膜环106的心室侧上，且近侧锚定器34的末端或尖端36在二尖瓣膜环106的心房侧上。远侧锚定器30能够经定位使得远侧锚定器30的末端或尖端32在原生叶状结构的心室侧上，超出腱索110连接到原生叶状结构的自由端的位置。远侧锚定器30可以在腱索110中的至少一些之间延伸，并且在一些情形中，例如在图13A到图13C中示出的那些情形中，能够接触或接合瓣膜环106的心室侧。此外，预期在一些情形中，例如在图14A和图14B中示出的那些情形中，远侧锚定器30可以不接触瓣膜环106，但是远侧锚定器30仍然可以接触原生叶状结构108。在一些情形中，远侧锚定器30能够接触左心室104的超出瓣膜环106和/或叶状结构的心室侧的组织。
在输送期间，远侧锚定器30(与框架20一起)能够朝向瓣膜环106的心室侧移动，其中远侧锚定器30在腱索110中的至少一些之间延伸以在腱索110上提供张力。腱索110上提供的张力程度能够不同。例如，在腱索110中可以存在极少张力到不存在张力，如图13C中所示，其中叶状结构108在大小上比远侧锚定器30短或类似于远侧锚定器30。在腱索110中可以存在更大程度的张力，如图13A和图13B中所示，其中叶状结构108比远侧锚定器30长，因而，采取压紧形式并向近端拉动。在腱索110中可以存在甚至更大程度的张力，如图14A和图14B中所示，其中叶状结构108比远侧锚定器30长更多。如图14A和图14B中所示，叶状结构108足够长，使得远侧锚定器30不接触瓣膜环106。
近侧锚定器34能够经定位使得近侧锚定器34的末端或尖端36邻近瓣膜环106的心房侧和/或左心房102的超出瓣膜环106的组织。在一些情形中，近侧锚定器34中的一些或全部可以仅偶尔接触或接合瓣膜环106的心房侧和/或左心房102的超出瓣膜环106的组织。例如，如图13A和图13B中所示，近侧锚定器34可以与瓣膜环106的心房侧和/或左心房102的超出瓣膜环106的组织隔开。近侧锚定器34可以提供对于假体10的轴向稳定性。在例如图13A和图14A中示出的那些情形的一些情形中，近侧锚定器34中的一些或全部可以不接触环形活瓣50。这可以在环形活瓣50处于折叠配置时出现，但是当环形活瓣50处于展开配置时也可以出现。在例如图13B、图13C和图14B中示出的那些情形的一些情形中，近侧锚定器34中的一些或全部可以接触环形活瓣50。这可以在环形活瓣50处于展开配置时出现，但是当环形活瓣50处于折叠配置时也可以出现。此外，预期近侧锚定器34中的一些或全部可以接触瓣膜环106的心房侧和/或左心房102的超出瓣膜环106的组织。
继续参考图13A到图14B中示出的情形，环形活瓣50能够经定位使得环形活瓣50的近侧部分51沿着或邻近瓣膜环106的心房侧定位。近侧部分51能够定位在瓣膜环106的心房侧与近侧锚定器34之间。近侧部分51能够径向向外延伸，使得环形活瓣50沿着或邻近左心房102的超出瓣膜环106的组织定位。环形活瓣50能够在活瓣50处于展开状态时在瓣膜环106的心房侧建立密封。
当左心室104中的压力增加时，活瓣50能够在心脏收缩期间从折叠状态转变为展开状态。左心室104内的此增加的压力能够使左心室104内的血液被引导到低压区域，例如主动脉(未示出)和左心房102。如上所述，在心脏收缩期间，瓣膜主体60可以被关闭从而防止血液返回流动到左心房102中。血液的相当大部分能够被迫围绕框架20和瓣膜主体60并流入环形活瓣50中，使得活瓣50能够展开。沿着瓣膜环106的心房侧的密封能够尤其有效。相比于环形活瓣50与瓣膜主体50之间的空间59的压力，左心房102能够处于低压下，其更接近左心室104的压力。在心脏收缩期间，左心房102与空间59之间的此类压差的存在能够允许活瓣50对左心房102内的周围组织施加更大的力。在心脏舒张期间，其中血液从左心房102朝向左心室104流动，活瓣50能够从展开状态转变回折叠状态。
在例如图13A和图14A中示出的那些情形的一些情形中，环形活瓣50可以不接触心脏100的壁。这可以在环形活瓣50处于折叠配置时出现，但是当环形活瓣50处于展开配置时也可以出现。在例如图13B、图13C和图14B中示出的那些情形的一些情形中，环形活瓣50可以接触心脏100的壁。这可以在环形活瓣50处于展开配置时出现，但是当环形活瓣50处于折叠配置时也可以出现。如图13A到图14B中所示，环形活瓣50还能够协助填充在叶状结构108与框架20之间存在的间隙(其部分以虚线示出)。
在例如在图15中示出的情形的一些情形中，叶状结构108可以不被捕获在框架20(其部分以虚线示出)与远侧锚定器30之间。如图所示，锚定器30可以沿着叶状结构108的心房表面定位。锚定器30还可以沿着瓣膜环106的内表面定位。此外，预期锚定器30可以针对叶状结构108施加力，使得叶状结构108相对于纵向轴线28朝向心脏100的壁被径向向外推动。在此类情形中，活瓣50能够在内部环状地和/或沿着叶状结构108的心房侧建立密封。在替代情形(未示出)中，活瓣50能够沿着瓣膜环106的心室侧建立密封。例如，心脏瓣膜替代品10可以设置在二尖瓣膜环中，使得环形活瓣50的一部分定位在原生瓣膜环106的心室侧上。
如上所述，虽然已经分别描述了图13A到图15的活体内情形，但是应理解，这些情形中的一种或更多种可以在假体位于植入位置(例如，原生二尖瓣膜)处时存在。例如，远侧锚定器30中的一个或更多个可以不捕捉叶状结构108，而其余的锚定器30可以捕捉叶状结构108。作为另一实例，当假体10定位在原生二尖瓣膜内时，环形活瓣50能够沿着近侧部分51的最外层圆周的一个或更多个部分接触心脏100的壁，并且可以沿着近侧部分51的最外层圆周的其它部分不接触心脏100的壁。例如，环形活瓣50可以沿着近侧部分51的最外层圆周的大约180度的部分接触心脏100的壁，并且可以沿着近侧部分51的最外层圆周的其余大约180度的部分不接触心脏100的壁。
心脏瓣膜替代品能够以不同方式输送到患者的心脏二尖瓣膜环，例如通过直视手术、微创手术以及经过患者的脉管的经皮或经导管输送。在一些实施例中，心脏瓣膜替代品能够以经心尖途径或经股动脉途径输送。
虽然已经在某些优选实施例和实例的上下文中公开了本发明，但是所属领域的技术人员应理解，本发明能延伸超出具体公开的实施例到其它替代实施例和/或本发明以及其显而易见的修改和等效物的使用。另外，虽然已经示出并详细描述了本发明的多个变化，但是所属领域的技术人员基于本发明将易于理解在本发明范围内的其它修改。此外，预期可以进行实施例的特定特征和方面的各种组合或子组合并仍然落入本发明的范围内。因此，应理解，所公开的实施例的各种特征和方面能够彼此组合或替代彼此以便形成本发明的变化模式。因此，希望本文中公开的本发明的范围不应受到上文描述的特定公开的实施例的限制，而是应仅通过所附权利要求书的正确解读来确定。
类似地，此公开方法不应被解释为反映任何权利要求需要比所述权利要求中所明确列举特征的更多特征的目的。实际上，如所附权利要求书所反映，发明性方面在于少于以上公开的任何单个实施例的所有特征的组合。因此，具体实施方式之前的权利要求书在此明确地并入此具体实施方式中，其中每项权利要求其自身代表单独的实施例。
Claims (11)
1.一种用于放置在体腔内的假体，所述假体经配置以抑制或减少瓣周漏，所述假体包括：
可展开框架，其包括近端和远端以及延伸穿过所述可展开框架的纵向轴线，所述框架经配置以径向展开和收缩，以便于部署在所述体腔内；
环形活瓣，其围绕所述可展开框架的外部定位并固定到所述可展开框架的外部，所述环形活瓣具有远侧边缘，所述远侧边缘固定在所述框架的所述远端处或所述远端附近，并延伸到固定在所述框架上在所述近端与所述远端之间的中间位置处的近侧边缘；以及
瓣膜主体，其定位在所述可展开框架的内部内，其中所述瓣膜主体包括：
固定到所述可展开框架的所述内部的内裙部；以及
经配置以允许在第一方向上的流动并防止在第二相反方向上的流动的多个叶状结构；
其中在所述框架的所述远端处或所述远端附近在所述环形活瓣与所述瓣膜主体之间界定开口，从而为流体流动到所述环形活瓣与所述瓣膜主体之间的空间中提供通路，并且其中流体流动到所述空间中致使所述环形活瓣从第一配置移动到第二配置，从而增加所述假体的表面积并当所述框架被部署在所述体腔内时建立流体在所述框架外部流动的屏障，其中在所述第一配置中所述活瓣更接近所述框架，在所述第二配置中所述活瓣更远离所述框架隔开。
2.根据权利要求1所述的假体，其进一步包括多个远侧锚定器，每个远侧锚定器连接到所述框架，使得当所述框架处于展开配置时，每个远侧锚定器的末端从所述框架径向向外定位并大体上向近侧延伸。
3.根据权利要求2所述的假体，其中所述多个远侧锚定器中的至少一些包括缓冲垫。
4.根据前述权利要求中任一权利要求所述的假体，其进一步包括多个近侧锚定器，每个近侧锚定器连接到所述框架，使得当所述框架处于展开配置时，每个近侧锚定器的末端从所述框架径向向外定位并大体上向远侧延伸。
5.根据前述权利要求中任一权利要求所述的假体，其进一步包括在所述框架的所述近端处或所述近端附近的束带。
6.根据前述权利要求中任一权利要求所述的假体，其中所述可展开框架包括界定多个缩短单元的多个支柱。
7.根据权利要求6所述的假体，其中所述环形活瓣的所述远侧边缘在所述框架的所述远端处附接到波形支柱。
8.根据前述权利要求中任一权利要求所述的假体，其中当所述框架处于展开配置时，所述框架的所述中间位置具有比所述框架的所述近端和所述远端更大的横截面尺寸。
9.根据前述权利要求中任一权利要求所述的假体，其中所述多个叶状结构经配置以允许从所述框架的所述近端到所述远端的流动并防止从所述远端到所述近端的流动。
10.根据前述权利要求中任一权利要求所述的假体，其中所述环形活瓣包括远离所述框架径向向外延伸的第一层弹性材料以及朝向所述框架的所述远端向远侧延伸的第二层弹性材料。
11.根据前述权利要求中任一权利要求所述的假体，其中所述可展开框架的至少一部分定位在所述环形活瓣与所述瓣膜主体之间的所述空间内。
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2015
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- 2015-05-19 CN CN201580025189.2A patent/CN106456328A/zh active Pending
- 2015-05-19 WO PCT/US2015/031612 patent/WO2015179423A1/en active Application Filing
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2017
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2019
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| WO2015179423A1 (en) | 2015-11-26 |
| US20190142585A1 (en) | 2019-05-16 |
| CA2948379A1 (en) | 2015-11-26 |
| US20170189179A1 (en) | 2017-07-06 |
| CA3161000A1 (en) | 2015-11-26 |
| US10179044B2 (en) | 2019-01-15 |
| CA2948379C (en) | 2022-08-09 |
| US20150328000A1 (en) | 2015-11-19 |
| EP3128952A1 (en) | 2017-02-15 |
| US11045313B2 (en) | 2021-06-29 |
| US20210315692A1 (en) | 2021-10-14 |
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