CN103118629A - 假体瓣膜支承结构 - Google Patents
假体瓣膜支承结构 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
- 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
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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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
- 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
- A61F2250/0048—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 mechanical expandability, e.g. in mechanical, self- or balloon expandability
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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
- 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
Abstract
本发明涉及包括支承结构的假体，该支承结构具有近端和远端，以及附连至支承结构远端上的运动限制构件，其中，运动限制构件构造成限制支承结构远端的径向膨胀。还提供了递送假体的方法。
Description
相关申请数据
本申请要求对2010年9月1日提交的美国临时专利申请No.61/379,115的优先权。
发明背景
发明领域
本发明涉及假体瓣膜及其植入方法。具体来说，本发明提供为经导管输送而构造的假体瓣膜支承结构。
背景
对罹患严重瓣膜疾病的患者进行大动脉瓣膜更换是一种常见的外科手术。该更换手术传统上通过开心外科术来实施，在此手术中，心脏通常被停止工作，并将患者放置在心脏旁路机器上。人们已经研发出包括人工心脏瓣膜的修复术，这样的修复使用最小创伤手术来植入，最小创伤手术诸如是前向经心尖途径的或经皮肤的方法。这些方法包括：径向地压缩假体以减小其直径，将假体插入到诸如导管那样的递送工具中，以及使递送工具前进到心脏内准确的解剖学位置上。一旦合适地定位，该假体就在天然瓣膜环内通过径向膨胀而展开。
如此的假体可包括将人工心脏瓣膜固定就位的支承结构。该假体的流入部分可经受来自体腔的径向紧配，体腔例如是左心室流出道（LVOT），其可将圆周径向压力作用在假体上。如此在假体的流入部分处的径向的紧配会导致假体的流出部分处的径向运动。如此的运动是不希望发生的。
此外，例如，由于瓣膜功能和心脏收缩缘故，假体会在流入部分处经受径向运动。如此的径向运动可造成流入部分的直径经历周期性的收缩和扩胀。这样的收缩和扩胀会使假体引起不必要的疲劳。
此外，由于患者解剖学的几何形和假体几何形之间达不到完全的一致，所以，可出现心脏瓣周泄漏。例如，假体和LVOT壁之间泄漏的主要根源是因为被称之为小叶间三角形的圆齿状小叶之间形成了空间。
因此，需要有一种假体，其使假体的流出部分和流入部分的径向运动解耦，该假体还能更好地符合于患者的解剖学结构。
授予Schwammental等人的PCT公开号WO 05/002466描述了用于治疗大动脉狭窄的假体装置，本文以参见方式引入该专利全部内容。
授予Schwammental等人的PCT公开号WO 06/070372描述了具有通过其间的单一流场的假体装置，其适于植入在对象内，并成形为形成流体入口、和在流体入口远端的分叉部分，本文以参见方式引入该专利全部内容。
授予Schwammental等人的美国专利申请公开号2006/0149360描述了一种假体装置，其包括附连到血管内瓣膜的瓣膜孔附连构件，并还包括流体入口和从流体入口延伸出来的分叉构件，该分叉构件包括靠近流体入口的近端和距离该近端的远端。分叉构件的远端部分具有比其近端部分大的横截面面积，以便流体流过其间。
授予Nguyen等人的美国专利申请公开号2006/0259136描述了一种心脏假体，该心脏假体具有支承瓣膜体的能自膨胀的多层框架，瓣膜体包括围裙部和多个接合的小叶。该框架在收缩递送结构和扩张展开结构之间转换，收缩递送结构能够经皮肤地经腔递送，而扩张展开结构具有非对称的沙漏形状。瓣膜体的围裙部和小叶这样进行构造：接合中心可以选择，以减小施加到瓣膜接合处的水平力，并有效地分配和传送沿着小叶和传到框架的力。替代地，瓣膜体可用作为外科方式植入的可更换的瓣膜假体。
发明概述
本发明提供一种能限制其远端径向运动的瓣膜假体支承结构。
本发明还提供一种能限制其近端径向运动的瓣膜假体支承结构。
本发明还提供一种包括能防止心脏瓣周泄漏的密封构件的瓣膜假体支承结构。
本发明提供一种包括支承结构的假体，假体具有近端和远端以及附连到支承结构远端的运动限制构件，其中，运动限制构件构造成限制支承结构远端的径向膨胀。
本发明还提供一种瓣膜假体支承结构，该支承结构包括可坍瘪和可膨胀的支承结构，该支承结构包括多个位于其远端处的柱和沿着近端方向从多个柱延伸出的向外张开的部分，以及附连至近端围裙部的近端的运动限制构件，其中，该运动限制构件构造成限制可坍瘪的支承结构近端的径向运动。
本发明还提供一种将假体递送到身体内要求部位的方法。该方法包括将递送系统的护套引入到对象的脉管内，其中，护套末端含有假体，将护套末端挺近到体内要求的部位，并将假体释放到体内，其中，假体包括支承结构，该结构具有近端和远端以及附连到支承结构远端的运动限制构件。
本发明其它的特征将在下面的描述中阐述。以上的一般性描述和下面的详细描述都是示范性的和解释性的，旨在对所提出的发明提供进一步深入的解释。
附图简介
这里所包含的附图构成本说明书的一部分，并说明本发明的示范实施例。诸附图还连同描述一起用来解释本发明的原理，并能使本技术领域内的技术人员作出和使用这里所述的示范实施例。在附图中，相同的附图标记表示相同的元件或功能类似的元件。
图1是在近端处经受径向紧配的瓣膜假体的立体图。
图2是尚未在近端处经受径向紧配的瓣膜假体的立体图。
图3是根据本发明实施例的瓣膜假体的立体图。
图4是图3所示瓣膜假体的示意俯视图。
图5是根据本发明实施例的瓣膜假体的立体图。
图6是图5所示瓣膜假体的示意侧视图。
图7是根据本发明实施例的瓣膜假体的立体图。
图8是图7所示瓣膜假体的示意俯视图。
图9是根据本发明实施例的瓣膜假体的立体图。
图10是图9所示瓣膜假体的示意侧视图。
图11是根据本发明实施例的瓣膜假体的立体图。
图12是根据本发明实施例的瓣膜假体的立体图。
发明详述
本发明以下的详细描述涉及说明示范实施例的附图。其它实施例也是可能的，并可落入本发明的范围之内。对于这里描述的示范实施例可以作出各种修改而不会脱离本发明的精神和范围。因此，以下的详细描述并不意味着限制。对所给出的示范实施例的操作和特性的描述，应理解到对示范实施例的各种修改和变化都会落入本发明的范围之内。
图1是在近端处经受径向紧配(radial interference)的瓣膜假体100的立体图。径向紧配可强迫或致使瓣膜假体100的一部分的直径发生变化。图2是尚未在近端处经受径向紧配的瓣膜假体100的立体图。瓣膜假体100包括位于其近端处的流入部分110,以及位于其远端处的流出部分120。瓣膜假体100还包括瓣膜假体支承结构130。
瓣膜假体支承结构130包括靠近流出部分120的柱122（也称作连合柱），以及从流入部分110朝向柱122延伸的近端围裙部132。
瓣膜假体100较佳地能够坍瘪，以便于经导管的递送。较佳地，瓣膜假体100可通过经皮股动脉入路进行递送。然而，瓣膜假体100也可通过其他经脉管入路方法或前向经心尖途径进行递送。瓣膜假体100接近递送到目标部位处时可径向地膨胀。目标部位最好是对象的天然大动脉环，但应该理解到，根据本发明的瓣膜也可植入到对象的其它位置（例如，天然二尖瓣环或肺动脉环）。
例如，含有瓣膜假体100的导管护套的末端可插入到患者脉管内（例如，通过诸如股动脉那样的体腔），并（沿着导向丝，如果提供该导向丝的话）前进到天然环的位置。环的天然小叶可在瓣膜假体100植入时就位，或可在植入之前瓣膜假体100部分地或全部地移去瓣膜假体100。导管的外管可缩回一定距离以暴露出近端围裙部132的近端部分。该近端部分可定位成邻接抵靠在大动脉环的心室侧。如果设置有倒刺的话，那么倒刺134可以是瓣膜假体100与瓣膜固定套筒内部的主要接触点，由此，在瓣膜假体100相对于导管护套移动时，可减小瓣膜固定套筒的内表面在瓣膜假体100上滑动所造成的摩擦。一旦确定瓣膜假体100合适地定位在环内，外管就可完全地缩回，释放瓣膜假体100并让瓣膜假体100径向地膨胀以啮合到环。在部分释放之后，如果确定假体未合适地定位，则可再次将流入部分110擒获到外管内以便重新定位。
瓣膜假体支承结构130可由自膨胀材料（例如，镍钛诺）制成，因此，其趋于朝向完全膨胀开的位置，该位置足以可靠地啮合天然环。当处在患者体内的位置时，这种趋势在瓣膜假体支承结构130和患者解剖学结构之间形成了径向力，因此有助于将瓣膜假体100固定就位。然而，由瓣膜假体支承结构130施加的力不需要自身充分地将瓣膜假体100锚固在天然环内。进一步阻止瓣膜假体100迁移可由轴向支承臂128来承担，支承臂突出在天然小叶的末端上，以对瓣膜假体100提供轴向支承，并防止瓣膜假体100在心动周期中通过天然小叶强迫进入到心室内。支承臂128可呈各种构造形式。此外，如上详述，流入部分110可啮合到天然环的流入端下方的心室，以提供附加的锚固。
例如，支承臂128可构造成至少部分地设置在对象的大动脉窦内，以在某些应用中啮合和/或搁置在大动脉窦的底面上，并施加朝向对象左心室的轴向力。支承臂128可在结合处彼此相遇。对于每个支承臂128制成分离件的应用来说，支承臂可机械地彼此啮合，它们相遇在结合之处。对于某些应用来说，支承臂128彼此相遇，但实际上互相并不接触，相反，通过各个结合处规定的区域来相遇。一般地，支承臂构造成在结合处形成尖峰以及相邻尖峰之间的低谷。2007年3月23日提交的美国专利申请号11/728,253以及2007年3月23日提交的美国专利申请号11/726,889详述了各种支承臂结构，本文以参见方式引入上述各个专利的全部内容。
在某些示范实施例中，瓣膜假体100包括三个柱122和扩口部分，三个柱围绕瓣膜假体100的纵向中心轴线圆周地布置，而扩口部分沿着近端方向从柱122延伸。在某些示范实施例中，瓣膜假体100包括多于或少于三个的柱122，例如，两个柱122，或四个柱122。人群中大约有90%的人正好有三个大动脉窦。某些实施例中所提供的三个柱122对应于人的三个大动脉窦。而对于大约10%的正好有两个大动脉窦的患者进行植入的情形，瓣膜假体100可包括仅两个柱122。
瓣膜假体100还可包括联接到柱122上的瓣膜150。瓣膜150可由顺从性材料制成，其构造成在心脏舒张期向内坍瘪（即，朝向瓣膜假体100的纵向中心轴线），以便阻止血流逆行，而在心脏收缩期中向内打开，以允许血流过瓣膜假体100。瓣膜150可用人造的或天然的组织来形成。例如，瓣膜150可用牛或猪的心包膜，或用任何合适的人造材料来形成。
图2是处于膨胀状态中的瓣膜假体100的立体图，其中，没有向内的径向压力或紧配力施加到流入部分110上。在该膨胀状态中，流入部分110具有直径ID2，而流出部分120具有流出流直径OD2。图1是在流入部分110处经受向内径向压力或紧配的瓣膜假体100的立体图。根据特殊对象的环的几何特性，由于在流入部分110处有径向紧配，所以，流入部分110经常处在如图1所示的至少有一些受压缩的位置中。在该位置在中，流出部分120具有比OD2大的流出流直径OD1，造成柱122定位得彼此比松弛状态更加远离。换句话说，瓣膜假体100在流出部分120处的流出流直径以及柱122的定位，都受到流入部分110处作用在瓣膜假体100上的径向紧配力的影响，这会导致瓣膜假体100性能特征的降低。
不管患者的解剖学结构如何特殊，通过提供更加可预计的和稳定的瓣膜几何形，令流出部分120的径向运动与流入部分110处的径向紧配向脱离，便可带来显著的益处。
图3是根据本发明实施例的瓣膜假体300的立体图。图4是瓣膜假体300的俯视图。瓣膜假体300的基本结构总体上类似于瓣膜假体100瓣膜假体100。瓣膜假体300包括位于其近端处的流入部分310以及位于其远端处的流出部分320。瓣膜假体支承结构330包括靠近流出部分320的柱322，以及从流入部分310朝向柱322延伸的近端围裙部332。瓣膜假体300也包括瓣膜假体支承结构330。
瓣膜假体300还包括运动限制构件324。该运动限制构件324包括大致刚性圆形框架，框架围绕流出部分320设置。该大致刚性圆形框架即使经受到诸如患者体腔内出现的外力时，也能较佳地基本上保持其形状。例如，大致刚性圆形框架可用传统上用来制作支架装置的外科用钢材类型制造。运动限制构件324通过附连到柱322的远端，便可安装到瓣膜假体支承结构330上。在如此的结构中，运动限制构件324通过限制流出部分320的最大直径来防止柱322分叉，由此，防止柱322的运动超过运动限制构件324所赋予的限值。运动限制构件324可用各种材料构造，例如，镍钛诺。
然而，运动限制构件324的刚性圆形框架可以是充分地柔软，以便在插入过程中与瓣膜假体300的坍瘪相兼容。
通过将框架附连到柱322的近端，或附连到柱322的中间位置，或近端和远端之间之内，那么，运动限制构件324的刚性圆形框架便可替代地或附加地安装到瓣膜假体支承结构330上。
由于流出部分320的直径受运动限制构件324限制，所以，流出部分320的直径基本上不受流入部分310直径变化的影响，由此，流出部分320的径向运动与流入部分310处的径向紧配脱离联接。因此，不管患者的解剖学结构如何特殊，瓣膜假体300都可保持可预计的和稳定的瓣膜几何形。
图5是根据本发明示范实施例的瓣膜假体500的立体图。图6是瓣膜假体500的示意侧视图。图5和6中所示实施例中的元件与以上所述实施例相同或相类似，因此可省略或简化对它们的描述。
瓣膜假体500包括位于其近端处的流入部分510以及位于其远端处的流出部分520。瓣膜假体500也包括瓣膜假体支承结构530和运动限制构件524。瓣膜假体支承结构530包括靠近流出部分520的柱522，以及从流入部分510朝向柱522延伸的近端围裙部532。
运动限制构件524包括靠近流出部分520设置的刚性拱。通过附连至两个相邻柱522的近端上，就可将每个刚性拱安装到瓣膜假体支承结构530上。这样，运动限制构件524的几个刚性拱一起围绕流出部分520延伸。在此结构中，运动限制构件524通过限制流出部分520的直径来防止柱522分叉，由此，防止柱522的运动超过运动限制构件524所赋予的限值。
在某些实施例中，运动限制构件524的诸刚性拱可一起形成圆形，或可形成其它形状，例如，围绕流出部分520连接的一系列相连的“隆起”。
在某些实施例中，运动限制构件524的刚性拱充分地柔软，以便在插入过程中随瓣膜假体500坍瘪。
在某些实施例中，通过将框架附连到柱522的近端，或附连到柱522的中间位置，或近端和远端之间内，那么，运动限制构件524的刚性拱便可安装到瓣膜假体支承结构530上。
在某些实施例中，运动限制构件524的刚性拱可从瓣膜假体支承结构530中延伸出来，其相对于延伸通过瓣膜假体500的纵向轴线成90度角度延伸出瓣膜假体支承结构530。替代地，运动限制构件524的刚性拱可从瓣膜假体支承结构530中延伸出来，其不以90度角度延伸，例如是大约30度，大约45度，或大约120度。此外，每个刚性拱不需要以与其它刚性拱相同的角度延伸出瓣膜假体支承结构530之外。
在某些实施例中，多个刚性拱可延伸在相邻的柱522之间。中间的连接可形成在相邻的刚性拱之间，以使延伸在相邻柱522之间的刚性拱串联连接。
因为流出部分520的直径受运动限制构件524限制，所以流出部分520的直径基本上不受流入部分510处径向紧配（即直径变化）的影响，由此，流出部分520的径向运动实现与流入部分510处的径向紧配脱离联接。因此，不管患者的解剖学结构如何特殊，瓣膜假体500都可保持可预计的和稳定的瓣膜几何形。
图7是根据本发明实施例的瓣膜假体700的立体图。图8是瓣膜假体700的示意侧视图。图7和8中所示实施例中的元件与以上所述实施例相同或相类似，因此可省略或简化对它们的描述。
瓣膜假体700包括位于其近端处的流入部分710以及位于其远端处的流出部分720。瓣膜假体700也包括瓣膜假体支承结构730和运动限制构件724。
瓣膜假体支承结构730包括靠近流出部分720的柱722，以及从柱722朝向流入部分710延伸的近端围裙部732。
运动限制构件724包括靠近流出部分720设置的线性支承元件。通过附连到两个相邻柱722的远端上，就可将每个线性支承元件安装到瓣膜假体支承结构730。在如此的结构中，运动限制构件724通过限制流出部分720的直径来防止柱722分叉，由此，防止柱722的运动超过运动限制构件724所赋予的限值。
在某些实施例中，运动限制构件724的线性支承元件不是刚性的，它们仅在拉升时起作用。例如，如此的线性支承元件可用线、丝、缝合线等制成。
在某些实施例中，运动限制构件724的线性支承元件是刚性的。
在某些实施例中，通过将支承元件附连到柱722的近端，或附连到柱722的中间位置，或近端和远端之间之内，那么，运动限制构件724的线性支承元件便可安装到瓣膜假体支承结构730上。
在某些实施例中，多个线性支承子元件可延伸在相邻柱722之间，使中间连接介于相邻的线性支承子元件之间，以使延伸在相邻柱722之间的线性支承子元件串联连接。
因为流出部分720的直径受运动限制构件724限制，所以，流出部分720的直径基本上不受流入部分710处径向紧配（即，直径变化）的影响，由此，流出部分720的径向运动实现与流入部分710处的径向紧配脱离联接。因此，不管患者的解剖学结构如何特殊，瓣膜假体700都可保持可预计的和稳定的瓣膜几何形。
图9是根据本发明实施例的瓣膜假体900的立体图。图10是瓣膜假体900的示意侧视图。图9和10中所示实施例中的元件与以上所述实施例相同或操作上相类似，因此可省略或简化对它们的描述。
瓣膜假体900包括位于其近端处的流入部分910以及位于其远端处的流出部分920。瓣膜假体900也包括瓣膜假体支承结构930和运动限制构件926。
瓣膜假体支承结构930包括靠近流出部分920的柱922，以及从流入部分910朝向柱922延伸的近端围裙部932。
运动限制构件926包括靠近流入部分910设置的支柱支承元件。每个支柱支承元件安装到流入部分910的近端，并延伸在近端围裙部932相邻端点之间。这样，运动限制构件926的诸支柱支承元件一起连接起流入部分910的端点。在如此的结构中，运动限制构件926通过限制流入部分910的直径来防止近端围裙部932的端点分叉，由此，防止近端围裙部932的端点的运动超过运动限制构件926所赋予的限值。
在某些实施例中，多个支柱支承元件可延伸在近端围裙部932的相邻端点之间，使中间连接介于近端围裙部932的相邻端点之间，以使延伸在近端围裙部932的相邻端点之间的支柱支承元件串联连接。
在某些实施例中，运动限制构件926的支柱支承元件纳入在近端围裙部932内并形成近端围裙部932的一部分，使得运动限制构件926和近端围裙部932一体地形成在一起。
在某些实施例中，运动限制构件926的支柱支承元件是刚性的。而在某些实施例中，运动限制构件的支柱支承元件是非刚性的。
因为流入部分910的直径受运动限制构件926限制，所以，流入部分910的运动由于瓣膜的功能和心脏收缩而可局限于合适发挥功能所必须的限值之内，由此消除或减小了不必要的径向运动。减小该不必要的径向运动又会减少瓣膜假体900所承受的疲劳，由此延长其使用寿命，并且其后不需要更换瓣膜假体900，或降低为维持合适的功能性而必须更换瓣膜假体900的频率。此外，因为运动限制构件926限制流入部分910的直径，所以，不管患者的解剖学结构如何特殊，瓣膜假体900却保持更加可预计的和稳定的瓣膜运动以及瓣膜的几何形。此外，流入部分910直径的稳定导致流出部分920的变形更小（即直径变化）。
图11是根据本发明实施例的瓣膜假体1100的立体图。图11中所示实施例的元件与以上所述实施例相同或操作上相类似，因此可省略或简化对它们的描述。
瓣膜假体1100包括位于其近端处的流入部分1110以及位于其远端处的流出部分1120。瓣膜假体1100也包括瓣膜假体支承结构1130和密封构件1142。
瓣膜假体支承结构1130包括靠近流出部分1120的柱1122，以及从柱1122朝向流入部分1110延伸的近端围裙部1132。
密封构件1142可靠近流入部分1110设置，并可定位成径向与柱1122对应。如此的定位对应于天然接合处，并使密封构件1142与患者小叶间的三角形对齐。密封构件1142的形状可匹配到小叶间的三角形内，或可用某种材料来形成，该种材料一旦放置成与小叶间的三角形相接触就会与小叶间的三角形的形状相一致。这样，密封构件1142帮助瓣膜假体1100达到与患者环的解剖学结构高度的一致性，由此，阻止或减小瓣周泄漏的机会和严重性。2011年4月21日提交的美国专利申请号13/091,765讨论了用于假体瓣膜的密封构件，本文以参见方式引入该申请的全部内容。
图12是根据本发明实施例的瓣膜假体1200的立体图。图12中所示实施例的元件与以上所述实施例相同或操作上相类似，因此可省略或简化对它们的描述。
瓣膜假体1200包括位于其近端处的流入部分1210以及位于其远端处的流出部分1220。瓣膜假体1200也包括瓣膜假体支承结构1230和密封构件1242。
瓣膜假体支承结构1230包括靠近流出部分1220的柱1222，以及从柱1222朝向流入部分1210延伸的近端围裙部1232。
密封构件1242可靠近流入部分1210设置，并可围绕近端围裙部1232的圆周延伸。密封构件1242可包括密封末端1244，其定位成径向地对应于柱1222。如此的定位对应于天然接合处，并使密封末端1244与患者小叶间的三角形对齐。密封末端1244的形状可匹配到小叶间的三角形内，或可用某种材料来形成，该种材料一旦放置成与小叶间的三角形相接触就会与小叶间的三角形的形状相一致。这样，包括密封末端1244在内的密封构件1242帮助瓣膜假体1200达到与患者环的解剖学结构高度的一致性，由此，阻止或减小瓣周泄漏的机会和严重性。
在某些实施例中，包括密封末端1244的密封构件1242用单一材料形成。在某些实施例中，密封末端1244用与密封构件1242其余部分不同的材料制成。例如，密封末端1244可用软材料形成，该软材料能够与患者小叶间的三角形相一致，而密封构件1242的其余部分可用更加刚性材料形成。
在某些实施例中，密封构件1242起作运动限制构件作用，并限制流入部分1210的直径，由此，防止近端围裙部1232端点的运动超过由密封构件1242所赋予的限值。这样，密封构件1242类似于运动限制构件926。
尽管以上描述了本发明的各种实施例，但这些实施例仅是借助于实例给出的，而不具限制性。以上给出实施例的元件不必是互相排斥的，但正如本技术领域内技术人员所认识到的，各元件可以互换以满足各种需要。
因此，本技术领域内的技术人员将会明白到，对于本文所揭示的实施例，在形式上和细节上可作出各种变化，而不会脱离本发明的精神和范围。文中所用的词语或术语只是用于描述，而不是作限制。因此，本发明意欲涵盖对本发明所作的各种修改和改变，只要它们落入附后权利要求书及其等价物的范围之内。
Claims (30)
1.一种假体，其包括：
具有近端和远端的支承结构；以及
附连到所述支承结构远端上的运动限制构件，
其中，所述运动限制构件构造成限制所述支承结构远端的径向膨胀。
2.如权利要求1所述的假体，其特征在于，所述运动限制构件包括刚性圆形框架。
3.如权利要求2所述的假体，其特征在于，所述支承结构包括位于其远端部分的多个柱，以及
其中，所述刚性圆形框架附连至所述多个柱中的各柱的远端。
4.如权利要求1所述的假体，其特征在于，所述运动限制构件包括多个刚性拱，每个刚性拱在相邻柱之间延伸。
5.如权利要求4所述的假体，其特征在于，每个刚性拱附连至相邻柱的近端。
6.如权利要求4所述的假体，其特征在于，所述刚性拱一起形成大致圆形的形状。
7.如权利要求4所述的假体，其特征在于，所述刚性拱充分地柔软以在所述假体的插入过程中坍瘪和膨胀。
8.如权利要求4所述的假体，其特征在于，所述刚性拱分别形成相对于延伸通过所述支承结构的纵向轴线的角度，并且所述角度在约30度至约120度的范围之内。
9.如权利要求1所述的假体，其特征在于，所述支承结构包括位于其远端部分的多个柱，以及
其中，所述运动限制构件包括多个线性支承元件，每个线性支承元件在相邻柱之间延伸。
10.如权利要求9所述的假体，其特征在于，各个线性支承元件附连至相邻柱的远端。
11.如权利要求9所述的假体，其特征在于，各个线性支承元件由非刚性材料制成。
12.如权利要求9所述的假体，其特征在于，各个线性支承元件由刚性材料制成。
13.如权利要求9所述的假体，其特征在于，各个线性支承元件包括串联连接的多个线性支承子元件。
14.如权利要求1所述的假体，其特征在于，所述运动限制构件构造成限制多个柱的径向运动。
15.如权利要求1所述的假体，其特征在于，还包括附连至所述支承结构的近端的密封构件，其中，所述密封构件的形状和结构被做成与患者心脏的小叶间三角形相一致。
16.如权利要求15所述的假体，其特征在于，所述支承结构包括位于其远端部分的多个柱，以及
其中，所述密封构件包括多个密封元件，每个密封元件定位成与对应的柱相对齐。
17.如权利要求15所述的假体，其特征在于，所述密封构件围绕支承结构的近端延伸。
18.如权利要求15所述的假体，其特征在于，所述支承结构包括位于其远端部分的多个柱，并且
其中，所述密封构件包括多个密封末端，并且所述密封构件定向成使每个密封末端元件与对应的柱相对齐。
19.一种假体，其包括：
可坍瘪且可膨胀的支承结构，所述支承结构包括位于其远端处的多个柱，以及从所述多个柱沿近端方向延伸的扩口部分；以及
运动限制构件，所述运动限制构件附连至所述支承结构的近端，
其中，所述运动限制构件构造成限制所述支承结构近端的径向运动。
20.如权利要求19所述的瓣膜假体支承结构，其特征在于，所述扩口部分包括凸起的近端部分，所述近端部分包括多个端点，并且
其中，所述运动限制构件包括多个支柱，每个支柱连接相邻的端点。
21.如权利要求19所述的瓣膜假体支承结构，其特征在于，所述扩口部分包括凸起的近端部分，所述近端部分包括多个端点，
其中，所述运动限制构件包括多个支柱，并且
其中，多个支柱连接相邻的端点。
22.如权利要求19所述的瓣膜假体支承结构，其特征在于，所述运动限制构件与所述支承结构形成一体。
23.如权利要求19所述的瓣膜假体支承结构，其特征在于，还包括附连到所述支承结构的密封构件，其中，所述密封构件的形状和结构被做成与患者心脏的小叶间三角形相一致。
24.如权利要求23所述的瓣膜假体支承结构，其特征在于，所述密封构件包括多个密封元件，每个密封元件定位在支承结构的近端以与对应的柱相对齐。
25.如权利要求23所述的瓣膜假体支承结构，其特征在于，所述密封构件定位在支承结构的近端，并围绕所述支承结构的近端延伸。
26.如权利要求23所述的瓣膜假体支承结构，其特征在于，所述密封构件包括多个密封末端，并且所述密封构件定向成使每个密封末端与对应的柱相对齐。
27.一种将假体递送到身体内要求部位的方法，所述方法包括：
将递送系统的护套引入到对象的脉管内，其中，所述护套的末端包含有假体；
使所述护套的末端前进到身体内的所述要求部位；以及
在身体内释放所述假体，
其中，所述假体包括：
具有近端和远端的支承结构；以及
附连至所述支承结构远端的运动限制构件。
28.如权利要求27所述的方法，其特征在于，所述支承结构包括位于其远端部分的多个柱，并且
其中，所述运动限制构件包括附连至各个柱的远端的刚性圆形框架。
29.如权利要求27所述的方法，其特征在于，所述支承结构包括位于其远端部分的多个柱，并且
其中，所述运动限制构件包括多个刚性拱，每个刚性拱在相邻柱之间延伸。
30.如权利要求27所述的方法，其特征在于，还包括附连至支承结构的密封构件，其中，所述密封构件的形状和结构被做成与患者心脏的小叶间三角形相一致。
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| US61/379,115 | 2010-09-01 | ||
| PCT/US2011/048988 WO2012030598A2 (en) | 2010-09-01 | 2011-08-24 | Prosthetic valve support structure |
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| CN103118629A true CN103118629A (zh) | 2013-05-22 |
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| CN2011800415875A Pending CN103118629A (zh) | 2010-09-01 | 2011-08-24 | 假体瓣膜支承结构 |
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| Country | Link |
|---|---|
| US (4) | US9918833B2 (zh) |
| EP (2) | EP2611388B1 (zh) |
| JP (1) | JP5874727B2 (zh) |
| CN (1) | CN103118629A (zh) |
| AU (1) | AU2011296361B2 (zh) |
| BR (1) | BR112013004962A2 (zh) |
| WO (1) | WO2012030598A2 (zh) |
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- 2011-08-24 US US13/216,533 patent/US9918833B2/en active Active
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| CN107106297B (zh) * | 2014-11-17 | 2020-01-21 | 二尖瓣辅助治疗有限公司 | 心脏瓣膜假体 |
| CN107205822A (zh) * | 2015-02-12 | 2017-09-26 | 美敦力公司 | 一体化瓣膜组件及递送和部署一体化瓣膜组件的方法 |
| CN104720936A (zh) * | 2015-03-26 | 2015-06-24 | 杭州启明医疗器械有限公司 | 使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置 |
| CN110831546A (zh) * | 2017-05-14 | 2020-02-21 | 心脏结构导航公司 | 用于功能失调的心脏瓣膜的原位置换的带瓣膜支架和递送系统 |
| CN110831546B (zh) * | 2017-05-14 | 2022-10-11 | 心脏结构导航公司 | 用于功能失调的心脏瓣膜的原位置换的带瓣膜支架和递送系统 |
| CN107928841A (zh) * | 2017-11-27 | 2018-04-20 | 上海形状记忆合金材料有限公司 | 一种分体式主动脉瓣膜支架组件 |
| CN107928841B (zh) * | 2017-11-27 | 2020-07-28 | 上海形状记忆合金材料有限公司 | 一种分体式主动脉瓣膜支架组件 |
| WO2021036125A1 (zh) * | 2019-08-29 | 2021-03-04 | 上海翰凌医疗器械有限公司 | 瓣膜支架及具有其的人工瓣膜 |
Also Published As
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|---|---|
| BR112013004962A2 (pt) | 2016-08-16 |
| WO2012030598A3 (en) | 2012-05-03 |
| WO2012030598A2 (en) | 2012-03-08 |
| AU2011296361A1 (en) | 2013-04-11 |
| US9918833B2 (en) | 2018-03-20 |
| JP5874727B2 (ja) | 2016-03-02 |
| US20180161158A1 (en) | 2018-06-14 |
| EP4052682A1 (en) | 2022-09-07 |
| US20120053682A1 (en) | 2012-03-01 |
| EP2611388A2 (en) | 2013-07-10 |
| JP2013539391A (ja) | 2013-10-24 |
| US10835376B2 (en) | 2020-11-17 |
| US20210022857A1 (en) | 2021-01-28 |
| EP2611388B1 (en) | 2022-04-27 |
| US20230414349A1 (en) | 2023-12-28 |
| US11786368B2 (en) | 2023-10-17 |
| AU2011296361B2 (en) | 2015-05-28 |
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