CN108366859A - 用于假体心脏瓣膜的心房囊袋闭合件 - Google Patents

用于假体心脏瓣膜的心房囊袋闭合件 Download PDF

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CN108366859A
CN108366859A CN201680072656.1A CN201680072656A CN108366859A CN 108366859 A CN108366859 A CN 108366859A CN 201680072656 A CN201680072656 A CN 201680072656A CN 108366859 A CN108366859 A CN 108366859A
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Z·维德伦德
M·伊文思
R·M·维德伦德
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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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
    • 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
    • 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
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • 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
    • A61F2230/0034—D-shaped
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种假体心脏瓣膜可以包括联接到内框架(450)的外框架(420)，以使得外框架能够在第一位置和第二位置之间移动，在第二位置中外框架相对于内框架翻转。内框架和外框架在其间限定环形空间，并且囊袋闭合件(480)可以界定环形空间以形成囊袋，血栓可以在囊袋中形成并且被保持在囊袋中。囊袋闭合件可以包括可拉伸的囊袋覆盖物(480)，所述可拉伸的囊袋覆盖物能够在第一位置和第二位置之间移动，在第一位置中当外框架处于相对于内框架的第一位置时囊袋覆盖物具有第一长度，在第二位置中当外框架处于相对于内框架的第二位置时囊袋覆盖物具有大于所述第一长度的第二长度。

Description

用于假体心脏瓣膜的心房囊袋闭合件
相关申请的交叉引用
本申请要求2015年12月28日提交的、发明名称为“用于假体心脏瓣膜的心房囊袋闭合件(Atrial Pocket Closures for Prosthetic Heart Valves)”且申请号为62/271,606的美国临时专利申请的优先权和权益，其公开内容通过引用整体并入本文。
本申请涉及2014年6月25日提交的申请号为PCT/US14/44047的国际申请，其是2014年1月15日提交的申请号为14/155,535的美国专利申请的部分继续申请，并且要求2013年6月25日提交的申请号为61/839,237的美国临时申请以及2013年6月27日提交的申请号为61/840,313的美国临时申请的优先权和权益。上述申请的公开内容通过引用整体并入本文。
背景技术
假体心脏瓣膜，包括用于插入房室瓣膜中的那些假体心脏瓣膜(三尖瓣和二尖瓣)，容易受到各种问题的影响，包括以下问题：瓣膜在自体瓣环内的不充分铰接和密封，由于心房引流不良引起的肺水肿，安装假体瓣膜周围的瓣周漏，假体瓣膜在自体瓣环内缺乏良好的配合，心房组织侵蚀，镍钛诺结构的过度磨损，二尖瓣环前侧处的主动脉的干扰，定制性的缺乏，以及血栓形成等。因此，对于能够解决这些问题中的一些或全部的假体心脏瓣膜存在需求。
而且，现有用于将假体心脏瓣膜递送和部署到房室瓣膜中的各种不同的递送方法，并且取决于递送方法，假体心脏瓣膜的期望特征和结构可以改变。例如，在假体心脏瓣膜的经血管递送中，期望具有一种假体心脏瓣膜，其可以具有用于植入心脏内的扩张构造和塌缩或压缩构造，所述塌缩或压缩构造具有足够小的外周边或直径以允许将假体心脏瓣膜安置在相对较小的递送导管或鞘中。在假体心脏瓣膜的这样的实施例中，也期望保持假体心脏瓣膜的某些特征例如上述的那些特征。
发明内容
在一些实施例中，一种假体心脏瓣膜可以包括外框架，所述外框架联接到内框架，以使得所述外框架可以在相对于所述内框架的第一位置和相对于所述内框架的第二位置之间移动，在所述第二位置中所述外框架相对于所述内框架翻转。所述内框架和所述外框架在其间限定环形空间。在一些实施例中，囊袋闭合件界定所述环形空间以形成囊袋，血栓能够在所述囊袋中形成并且被保持在所述囊袋中。所述囊袋闭合件可以包括可拉伸的囊袋覆盖物，所述可拉伸的囊袋覆盖物能够在第一位置和第二位置之间移动，在所述第一位置中当所述外框架处于相对于所述内框架的第一位置时所述囊袋覆盖物具有第一长度，在所述第二位置中当所述外框架处于相对于所述内框架的第二位置时所述囊袋覆盖物具有大于所述第一长度的第二长度。
附图说明
图1A和1B分别是根据实施例的假体心脏瓣膜的示意性透视图和侧视横截面图。
图2A是图1A和1B的假体心脏瓣膜的内瓣膜组件的示意性透视图。
图2B和2C是分别示出为处于第一构造和第二构造的图2A的内瓣膜的示意性俯视图。
图3-5分别是根据另一实施例的假体心脏瓣膜的前视图、仰视图和俯视图。
图6A和6B是分别示出为处于第一构造和第二构造的根据实施例的假体心脏瓣膜的一部分的示意图。
图6C和6D是分别示出为布置在递送鞘内的图6A和6B的假体心脏瓣膜的一部分的示意图。
图7A和7B是分别示出为处于第一构造和第二构造的图6A和6B的假体心脏瓣膜的一部分的示意图。
图8A是示出为处于第一构造的根据另一实施例的假体心脏瓣膜的前视图。
图8B是示出为处于第二构造的图8A的假体心脏瓣膜的前视图。
图9A是示出为处于第一构造的根据另一实施例的假体心脏瓣膜的前视图。
图9B是图9A的假体心脏瓣膜的圈出部分A的放大图。
图9C是示出为处于第二构造的图9A的假体心脏瓣膜的前视图。
图10A是根据另一实施例的假体心脏瓣膜的横截面侧视图。
图10B是图10A中的圈出区域A的放大图。
图10C是图10A的假体心脏瓣膜的透视图。
图10D是根据另一实施例的假体心脏瓣膜的透视图。
具体实施方式
本文描述了假体心脏瓣膜，其包括联接到内框架的外框架。外框架和内框架在其间限定环形空间，并且囊袋闭合件界定环形空间以形成囊袋，血栓能够在所述囊袋中形成并且被保持在所述囊袋中。在一些实施例中，假体心脏瓣膜包括联接到内框架的外框架，以使得外框架能够在相对于内框架的第一位置和相对于内框架的第二位置之间移动，在所述第二位置中外框架相对于内框架翻转。在这样的实施例中，囊袋闭合件可以包括可拉伸的囊袋覆盖物，所述可拉伸的囊袋覆盖物能够在第一位置和第二位置之间移动，在所述第一位置中当所述外框架处于相对于所述内框架的第一位置时所述囊袋覆盖物具有第一长度，在所述第二位置中当所述外框架处于相对于所述内框架的第二位置时所述囊袋覆盖物具有大于所述第一长度的第二长度。
在一些实施例中，本文描述的假体心脏瓣膜可以构造成移动到翻转构造以用于将假体瓣膜递送到患者的心脏内。例如，在一些实施例中，假体瓣膜包括外框架，当假体瓣膜处于偏压扩张构造时，外框架可以相对于内框架翻转。假体二尖瓣可以用例如形状记忆材料形成。在翻转外框架之后，假体瓣膜可以插入递送鞘的管腔中，使得假体瓣膜移动到塌缩构造。
递送鞘可以用于使用各种不同的递送方法将如本文所述的翻转的假体瓣膜递送至患者心脏内，这些递送方法用于递送假体心脏瓣膜(例如，假体二尖瓣)且其中翻转的假体瓣膜将通过心脏的心房进入心脏。例如，本文所述的假体瓣膜可以使用如上文通过引用并入的申请号为PCT/US15/14572的国际申请('572PCT申请)中所述的经股动脉递送方法来递送，或者经由例如在2015年9月18日提交的、发明名称为“用于经心房递送假体二尖瓣的装置和方法(Apparatus and Methods for Transatrial Delivery of ProstheticMitral Valve)”且申请号为62/220,704的美国临时专利申请(“'704临时申请”)和2016年9月14日提交的申请号为15/265,221的美国专利申请('221申请)中所述的经心房方法来递送，上述申请的全部公开内容通过引用整体并入本文。在另一示例中，如本文所述的翻转的瓣膜可以经由经颈静脉方法、经由右心房并通过心房隔膜进入左心房来递送，正如'221申请中所述。在必要的情况下，本文所述的假体瓣膜也可以心尖递送。在递送鞘已布置在心脏的左心房内之后，将假体二尖瓣朝远侧移出递送鞘，使得翻转的外框架复原并且假体瓣膜呈现其偏压扩张构造。然后即可将假体二尖瓣定位在心脏的二尖瓣环内。
假体心脏瓣膜100的示意图在图1A和1B中示出。假体心脏瓣膜100(也称为“假体瓣膜”或“瓣膜”)设计成置换受损或患病的自体心脏瓣膜例如二尖瓣。瓣膜100包括外框架组件110和联接到外框架组件的内瓣膜组件140。
尽管未在图1A和1B中的外框架组件110的示意图中单独示出，但外框架组件110可以由外框架120形成，并且可以在其外表面的全部或一部分上覆盖有外覆盖物(未示出)，并且在其内表面的全部或一部分上由内覆盖物(未示出)覆盖。以下参考图3-5描述示出了内覆盖物和外覆盖物的假体瓣膜的实施例。在一些实施例中，外框架组件110可以在外框架120的仅外表面或者仅内表面上包括覆盖物。在一些实施例中，在外框架120的内表面和/或外表面上可以有一个以上的覆盖物层。外框架组件110的内覆盖物和外覆盖物可以完全覆盖外框架120的内表面和/或外表面，或者可以部分地覆盖外框架120的内表面和/或外表面。在一些实施例中，外框架组件110可以不包括外框架120的内表面或外表面上的覆盖物。例如，在一些实施例中，外框架组件110可以不包括外框架120的内表面上的材料或覆盖物并且包括布置在外框架120的外表面上的两层材料或覆盖物。在这样的实施例中，第一层材料或覆盖物可以是例如完全覆盖外框架120的外表面的组织，并且最外层材料或覆盖物可以是仅覆盖外框架120的一部分的薄聚酯。例如，最外侧的覆盖物可以覆盖外框架120的护套部分的一排或两排孔眼。
外框架120可以为假体心脏瓣膜100提供若干种功能，包括用作将瓣膜锚固到自体心脏瓣膜装置的主要结构、锚固机构和/或独立锚固机构的附接点，承载内瓣膜组件140的支撑件，和/或抑制假体心脏瓣膜100和自体心脏瓣膜装置之间的瓣周漏的密封件。
外框架120优选地形成为使其可以变形(压缩和/或扩张)，并且当释放时返回到其原始(未变形)形状。为此，外框架120优选由具有形状记忆性质的材料(如金属或塑料)形成。关于金属，已发现特别有效，原因是它可以被加工成奥氏体、马氏体或超弹性体。可以使用其他的形状记忆合金，例如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。
外框架120优选由的激光切割的薄壁管形成。激光切割在细管中形成规则的切口。该管可以径向扩张，置于期望形状的模具或心轴上，加热到马氏体温度，并且淬火。以该方式处理框架将形成开放式网格框架结构，并且可以在外框架120的心房端部分116处具有张开的端部或护套。外框架120因此具有形状记忆性质并且将容易在校准温度下恢复到记忆形状。替代地，外框架120可以由编织丝或其他合适的材料构造。
在图2A-2C中更详细地且示意性地示出了内瓣膜组件140。内瓣膜组件140可以包括内框架150、外覆盖物160和瓣叶170。在图2A中示意性地示出的简化形式中，内框架150包括支撑外覆盖物160和瓣叶170的六个轴向柱或框架构件。瓣叶170沿着柱中的三个(在图2A中示出为连合柱152)附接，并且外覆盖物160附接到其他三个柱(图2A中的154)，并且可选地附接到连合柱152。外覆盖物160可以附接到内框架150的内表面或内框架150的外表面。如图2A中示意性地所示，外覆盖物160和瓣叶170中的每一个由近似矩形的材料片形成，所述材料片在它们的上端或心房端处联结在一起。外覆盖物160的下心室端可以联结到外框架组件110(在图2A中未示出)的内覆盖物(未示出)，并且瓣叶170的下心室端可以形成自由边缘，但是联接到连合柱152的下端。在一些实施例中，覆盖物160和瓣叶170可以由单个矩形材料片形成，然后折叠并修剪成内框架的形状，在进行材料折叠的内框架的顶部处保持连接。在一些实施例中，覆盖物160和/或瓣叶170可以由具有不同于矩形的形状的材料形成，例如由半圆形材料片形成，或者可以被激光切割成内框架的形状。
如图2B和2C中所示，瓣叶170能够在第一或敞开构造(图2B)和第二或闭合构造(图2C)之间移动，在所述第二或闭合构造中瓣叶170合紧或者以紧密抵接的方式相接。
在下端或心室端，瓣叶170可以具有比外覆盖物160更小的周边。因此，连合柱152之间的瓣叶170的自由下边缘(相邻连合柱之间的瓣叶170的每个部分被称为瓣叶170的“腹部”)与外覆盖物160的下边缘径向地间隔开。该径向间隔便于瓣叶从图2B中的敞开位置移动到图2C中的闭合位置，原因是在心脏收缩期间从心室到心房的血液的逆流可以捕获腹部的自由边缘并推动瓣叶闭合。
外框架组件110的外覆盖物和内覆盖物、外覆盖物160以及瓣叶170可以由任何合适的材料或材料的组合形成。在一些实施例中，外框架组件110的外覆盖物和内覆盖物、外覆盖物160以及瓣叶170可以由组织形成。在一些实施例中，组织可选地是生物组织例如来自动物(例如猪)的心脏瓣膜的化学稳定的组织，或者是动物的心包组织例如牛(牛心包)、羊(羊心包)、猪(猪心包)、或马(马心包)。合适的组织的示例包括在产品和中使用的合适组织，所有产品目前用于外科程序，并且市售产品通常是从不到30个月大的牛获取。替代地，瓣叶170可以可选地由心包组织或小肠粘膜下组织制成。
诸如聚氨酯或聚四氟乙烯的合成材料也可以用于瓣叶170。在薄的、耐用的合成材料预期例如用于外框架组件110的外覆盖物或内覆盖物的情况下，可以可选地使用合成聚合物材料，如膨体聚四氟乙烯或聚酯。其他合适的材料可以可选地包括热塑性聚碳酸酯氨基甲酸乙酯、聚醚氨基甲酸乙酯、嵌段聚醚氨基甲酸乙酯、硅氧烷聚醚氨基甲酸酯、硅氧烷-聚碳酸酯氨基甲酸乙酯、以及超高分子量聚乙烯。附加的生物相容性聚合物可以可选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯吡咯烷酮、聚氯乙烯、其他含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯、以及使用上述材料的嵌段共聚物。
在另一实施例中，瓣叶170可以可选地具有已用抗凝剂(例如但不限于固定化肝素)处理(或与其反应)的表面。这样的目前可用的肝素化聚合物是本领域普通技术人员已知的和可用的。
如图1A、1B和2A中所示，内瓣膜组件140可以为大致圆柱形，并且外框架组件110可以为锥形，从下心室部分112(其联接到内瓣膜组件140的位置)处的较小直径(略大于内瓣膜组件140的外径)延伸到较大直径的心房部分116，相应地在心房部分116和心室部分112之间具有中间直径的瓣环部分114。
因此在内瓣膜组件140的外表面和外框架组件110的内表面之间形成锥形的环形空间或囊袋185(在本文中也称为“心房囊袋”)，其通向瓣膜组件100的心房端。当瓣膜组件100布置在自体心脏瓣膜的瓣环中时，来自心房的血液可以移动进入和离开囊袋185。血液可以凝结，形成血栓。为了增强凝结，组织向内生长到瓣膜100的表面中并产生其他益处，可以通过囊袋闭合件180(也称为“心房囊袋闭合件”)覆盖或封闭囊袋。
囊袋闭合件180可以至少部分地由任何合适的材料形成，其足够多孔以允许血液(特别是包括红血细胞)进入囊袋185，但不是多孔到非期望地允许大的血栓离开囊袋185的程度。例如，囊袋闭合件180可以至少部分地由具有小于160μ、优选在90μ至120μ之间的孔的机织或针织聚酯织物形成。在一些实施例中，囊袋闭合件180可以至少部分地由具有期望孔隙率的编织镍钛诺材料形成。在一些实施例中，囊袋闭合件180可以至少部分地由编织管状镍钛诺材料形成。不需要让整个囊袋闭合件180都由具有相同孔隙率的相同材料形成。例如，囊袋闭合件180的一些部分可以由较少孔隙或不透血液的材料形成，并且其他部分由上述孔隙率范围的材料形成。也可以预期，外框架组件110或内瓣膜组件140的一部分可以形成有与囊袋180连通的孔，所述孔由具有期望孔隙率的材料形成的闭合件覆盖，因此提供了另一路径，血液可以通过所述路径进入心房囊袋185，但防止血栓离开心房囊袋185。
内瓣膜组件110的外表面和/或外框架组件140的内表面不需要在横截面上为圆形(如图1A和1B中示意性所示)，而是可以在沿着瓣膜100的中心轴线的指定位置处具有非恒定的半径。因此，囊袋185可以不具有恒定的横截面，并且可以不连续，而是可以形成为两个或更多个流体隔离的、部分环形的容积。类似地，囊袋闭合件180不需要成形为具有恒定宽度的环(如图1A和1B示意性所示)，而可以是随着更复杂的连续形状而变化的连续环，或者可以形成为多个不连续的部段。在一些实施例中，囊袋闭合件180可以形成为限定内部区域的管状构件。
囊袋闭合件180用于捕获和/或减慢囊袋185内的血液流动，其可以增加血栓在囊袋185中的形成和保持。它也促进自体组织主动向内生长到假体心脏瓣膜100的若干覆盖物中，将瓣膜100进一步稳定在自体心脏瓣膜中。形成内瓣膜组件140的外覆盖物的材料也可以被硬化或加强，以为瓣叶170提供更好的支撑。另外，填充囊袋185的一定量的血栓可以用作内瓣膜组件140的封装物(potting)，以进一步稳定瓣膜组件。内瓣膜组件140的更好的稳定性可以提供瓣叶170的更可靠合紧，并且因此提供更有效的性能。在外框架组件110已安装到并且挠性地贴合自体瓣膜装置之后一定量的血栓也可以稳定外框架组件110。这可以在假体心脏瓣膜100和自体瓣膜装置之间提供更有效的密封，并且减小瓣周漏。
图3-5分别是根据实施例的假体心脏瓣膜200的前视图、仰视图和俯视图。假体心脏瓣膜200(在本文中也称为“瓣膜”或“假体瓣膜”)设计用以置换受损或患病的自体心脏瓣膜例如二尖瓣。瓣膜200包括外框架组件210和联接到外框架组件210的内瓣膜组件240。
如图所示，外框架组件210包括外框架220，在其外表面的全部或一部分上覆盖有外覆盖物230，并且在其内表面的全部或一部分上由内覆盖物232覆盖。外框架220可以为假体心脏瓣膜200提供若干种功能，包括用作将瓣膜锚固到自体心脏瓣膜装置的主要结构、锚固机构和/或独立锚固机构的附接点；承载内瓣膜组件240的支撑件；和/或抑制假体心脏瓣膜200和自体心脏瓣膜装置之间的瓣周漏的密封件。
外框架220具有偏压扩张构造，并且可以被操纵和/或变形(例如被压缩和/或被约束)，并且当释放时返回其原始的不受约束的形状。为此，外框架220可以由具有形状记忆性质的材料(例如金属或塑料)形成。关于金属，已发现特别有效，原因是它可以被加工成奥氏体、马氏体或超弹性体。也可以使用其他的形状记忆合金例如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。
如图3中最佳地所示，外框架组件210具有上端(例如，在心房部分216处)、下端(例如，在心室部分212处)、以及其间的中间部分(例如，在瓣环部分214处)。上端或心房部分216(也称为“自由的端部部分”或“敞开的端部部分”)限定外框架组件210的敞开的端部部分。外框架组件210的中间或环形部分214具有构造成(例如，尺寸确定成，成形为)配合到自体房室瓣膜的瓣环中的周边。外框架组件210的上端的周边比中间部分的周边大。在一些实施例中，外框架组件210的上端的周边明显大于中间部分的周边。如图5中最佳地所示，外框架组件210的上端和中间部分具有D形横截面。以该方式，外框架组件210促进合适地配合到自体房室瓣膜的瓣环中。
内瓣膜组件240包括内框架250、外覆盖物260和瓣叶270。如图所示，内瓣膜组件240包括具有形成有多个拱部的周边的上部分。内框架250包括支撑外覆盖物260和瓣叶270的六个轴向柱或框架构件。瓣叶270沿着示出为连合柱252(在图4中最佳地示出)的柱中的三个柱附接，并且外覆盖物260附接到其它三个柱254(在图4中最佳地示出)，并且可选地附接到连合柱252。外覆盖物260和瓣叶270中的每一个可以如上文关于外覆盖物160和瓣叶170所述地形成。例如，外覆盖物260和瓣叶270中的每一个可以由近似矩形的材料片形成，所述材料片在它们的上端或心房端处联结在一起。外覆盖物260的下心室端可以联结到外框架组件210的内覆盖物232，并且瓣叶270的下心室端可以形成自由边缘275，但是联接到连合柱252的下端。
尽管内瓣膜组件240示出为具有三个瓣叶，但在其他实施例中，内瓣膜组件可以包括任何合适数量的瓣叶。瓣叶270能够在敞开构造和闭合构造之间移动，在所述闭合构造中瓣叶270合紧或者以紧密抵接的方式相接。
外框架组件210的外覆盖物230和外框架组件210的内覆盖物232、内瓣膜组件240的外覆盖物260和内瓣膜组件240的瓣叶270可以由任何合适的材料或材料的组合形成，例如上面关于瓣膜100讨论的那些。在该实施例中，外框架组件210的内覆盖物232、内瓣膜组件240的外覆盖物260和内瓣膜组件240的瓣叶270至少部分地由猪心包形成。而且，在该实施例中，外框架组件210的外覆盖物230至少部分地由聚酯形成。
假体瓣膜200还限定了在内瓣膜组件240的外表面和外框架组件210的内表面之间形成的锥形的环形空间或囊袋(未示出)，其通向瓣膜组件200的心房端。如图所示，囊袋闭合件或覆盖物280(在图5的俯视图中囊袋布置在囊袋闭合件280下方)沿着内瓣膜组件240的上端的周边联接并且也联接到外瓣膜组件210。在一些实施例中，囊袋闭合件280或其一部分可以沿着内瓣膜组件240的任何合适的部分联接。
如上所述，囊袋闭合件280可以至少部分地由任何合适的材料形成，其足够多孔以允许血液(特别是包括红血细胞)进入囊袋，但没有多孔到非期望地允许大的血栓离开囊袋的程度。在该实施例中，囊袋闭合件280完全由具有约90-120微米的孔的针织聚酯(即，PET经编针织织物)形成。在一些实施例中，囊袋闭合件可以包括小于约160微米的孔。
如前所述，在一些实施例中，假体心脏瓣膜(如假体二尖瓣)可以构造成移动到翻转构造以用于将假体瓣膜递送到患者的心脏内。例如，外框架可以相对于瓣膜的内框架移动或翻转。在翻转外框架之后，假体瓣膜可以插入递送鞘的管腔中，使得假体瓣膜移动到塌缩构造以用于将瓣膜递送到心脏。图6A-6D以及图7A和7B示意性地示出了可以在用于使用的偏压扩张构造和用于递送到心脏的翻转构造之间移动的假体瓣膜的实施例。
图6A和6B是示出为分别处于第一构造和第二构造的根据实施例的假体心脏瓣膜300的一部分的示意图，并且图6C和6D分别示出了示出为布置在递送鞘326的管腔内的图6A和6B的假体心脏瓣膜300的部分。图7A和7B分别示出了图6A和6B的假体心脏瓣膜300的一部分，并且示出了处于第一构造和第二构造中的每一个构造中的假体心脏瓣膜的长度尺寸。假体心脏瓣膜300(在本文中也称为“假体瓣膜”或“瓣膜”)可以是例如假体二尖瓣。瓣膜300包括外框架320和内框架350。外框架320和内框架350均形成为管状结构。外框架320和内框架350可以在围绕内框架350的周边和外框架320的周边布置的多个联接接头346处联接在一起，如下面更详细地所述。瓣膜300也可以包括其他特征，例如上面关于图1-5所述的那些特征。例如，瓣膜300可以包括具有外框架320的外框架组件、以及具有内框架350的内瓣膜组件，其可以与上面关于图1-5所述的外框架组件和内瓣膜组件相同或相似地形成或构造。为了说明的目的，关于图6A-7B仅讨论内框架350和外框架320。关于图6A-7B所述的瓣膜300的各种特性和特征可以应用于本文描述的任何假体瓣膜。
外框架320构造成具有偏压扩张或未变形的形状，并且可以被操纵和/或变形(例如被压缩或被约束)，并且当释放时返回其原始(扩张或未变形的)形状。例如，外框架320可以由具有形状记忆性质的材料(如金属或塑料)形成。关于金属，已发现特别有效，原因是它可以被加工成奥氏体、马氏体或超弹性体。也可以使用其他的形状记忆合金如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。内框架350可以由的激光切割管形成。内框架350也可以具有偏压扩张或未变形的形状，并且可以被操纵和/或变形(例如被压缩和/或被约束)，并且当释放时返回其原始(扩张或未变形的)形状。在下文中并且参照瓣膜200和图3-5描述关于内框架350和外框架320的更多细节。
可以使用各种不同的递送方法将瓣膜300递送并部署在心脏的左心房内，例如，所述递送方法包括如'572PCT申请中所述的经股动脉递送方法，或者如'704临时申请和'221申请中所述的经心房递送方法，或者如'221申请中所述的经颈静脉递送方法。如上所述，在一些情况下，例如当通过经股动脉、经颈静脉或经心房递送方法将假体瓣膜递送至心脏时，由于递送鞘的管腔的尺寸较小，因此在递送期间假体瓣膜的尺寸应该适当地确定。因此，希望获得一种假体瓣膜，其能够在用于植入心脏中(例如，植入自体二尖瓣环内)的偏压扩张构造和具有较小外周边或轮廓以允许在递送鞘的管腔内递送的递送构造之间进行重构。假体瓣膜300和本文描述的假体瓣膜的实施例可以构造和形成用以实现这些期望的功能和特性。
更具体地，瓣膜300可以具有偏压扩张构造(如图6A和7A中所示)、翻转构造(如图6B和7B中所示)和压缩或塌缩构造(如图6C和6D中所示)。扩张构造允许瓣膜300在植入心脏内时起作用。瓣膜300可以移动到翻转构造和压缩或塌缩构造以用于将瓣膜300递送到患者的心脏。
为了使瓣膜300能够移动到翻转构造，外框架320能够以允许外框架320相对于内框架350移动的方式联接到内框架350。更具体地，联接接头346能够以允许外框架320相对于内框架350移动的方式将外框架320联接到内框架350。例如，在一些实施例中，联接接头346可以构造成允许外框架320相对于内框架350围绕联接接头346旋转。在一些实施例中，联接接头可以提供外框架320和内框架350之间的枢转联接。在一些实施例中，联接接头可以提供外框架320和内框架350之间的挠性附接。联接接头346可以是如本文中参考假体瓣膜的各种实施例所述的各种不同类型和构造。例如，联接接头146可以包括活动铰链、挠性构件、缝线、通过开口包裹的缝线、通过开口插入的销或凸耳、或其任意组合。
为了将瓣膜300从扩张构造(图6A)移动到翻转构造(图6B)，通过使外框架320围绕联接接头346移动(例如，旋转、枢转、挠曲)，外框架320相对于内框架350移动到脱垂或翻转构造，如图6B、6D和7B中所示。瓣膜300的外框架320的弹性或超弹性结构也允许外框架320相对于内框架350移动到并且布置成脱垂或翻转构造。为了将外框架320相对于内框架350移动到翻转构造，外框架320经由联接接头346相对于内框架350朝远侧(在图6B中向右)折叠或翻转。如图6A和7A中所示，外框架320在被翻转之前处于相对于内框架350的第一位置，其中敞开或自由的端部部分316(也称为外框架320的心房部分316)布置在联接接头346的近侧或左侧并且布置在与内框架350的自由端部部分347(也称为内框架的第二端部部分)相同的方向上。当外框架320移动到翻转构造(即，相对于内框架350的第二位置)时，自由端部部分316布置在联接接头346的远侧(或在图6B和7B中向右)并且布置在与内框架350的自由端部部分347相反的方向上。换句话说，当瓣膜300处于偏压扩张构造(例如，图6A)时，联接接头346布置在内框架350的第一端部部分344(也称为系绳联接部分)和外框架320的自由端部部分316之间。当瓣膜300处于翻转构造(例如，图6B)(即，外框架320已移动到翻转构造或翻转位置)时，联接接头346布置在内框架350的自由端部部分或第二端部部分347和外框架320的自由端部部分316之间。
当处于翻转构造时，瓣膜300的总长度增加，但内框架350的长度和外框架320的长度保持相同(或基本相同)。例如，如图7A和7B中所示，处于偏压扩张构造(在翻转之前，如图7A中所示)的瓣膜300的总长度L1小于处于翻转构造(图7B)时的瓣膜300的总长度L2。当瓣膜300处于偏压扩张构造和翻转构造这两种构造时，内框架350的长度Li和外框架320的长度Lo基本相同(或相同)。另外，在一些情况下，取决于外框架的具体构造，当瓣膜300处于翻转构造时，瓣膜300的总外周长或外径可以更小。
在瓣膜300处于翻转构造的情况下，瓣膜300可以放置在递送鞘326的管腔内以用于将瓣膜300递送到心脏的左心房，如图6D中所示。当放置在递送鞘326的管腔内时，瓣膜300移动到塌缩或压缩构造，其中瓣膜300的外径或外周长减小。由于瓣膜300处于翻转构造，因此瓣膜300能够放置在更小的递送鞘326内(与在其他情况下可以进行放置的递送鞘相比)。例如，为了比较的目的，图6C示出了放置在递送鞘326'的管腔内的瓣膜300，其中在布置在递送鞘326'内之前，瓣膜300尚未移动到翻转构造。如图6C中所示，当以翻转构造放置在递送鞘326中时，瓣膜300的外径减小，但没有像瓣膜100的直径那样小。因此，在图6C中，瓣膜300具有总外周长或外径D1，并且在6D中，瓣膜300具有小于D1的总外周长或外径D2。
因此，通过将外框架320布置成翻转构造，瓣膜300可以塌缩成较小的总直径，即放置在更小直径的递送鞘326中(与瓣膜300仅径向塌缩时可以进行放置的递送鞘相比)。这是由于当瓣膜处于偏压扩张构造时，内框架350嵌套在外框架320的内部中，并且因此外框架320必须围绕内框架350塌缩。在一些实施例中，内框架350和外框架同心地布置。而在翻转构造中，内框架350和外框架320相对于彼此轴向布置(即，内框架不嵌套在外框架350内)，使得外框架320可以塌缩而不需要以适应其内部的内框架350的所有结构。换句话说，在内框架350大部分布置在外框架320内部或嵌套在外框架320内的情况下，框架结构的层或块体不能被压缩到像直径那样小。另外，如果框架嵌套，则结构的挠性较小，并且因此需要更大的力来弯曲瓣膜，例如以便穿过曲折的脉管系统或在穿过房间隔后在左心房中进行急转以适当地取向成用于插入二尖瓣环中。
图8A和8B示出了假体心脏瓣膜的另一实施例，其可以使用各种不同的递送方法递送和部署在心脏的左心房内并且可以如上面关于瓣膜300所述在扩张构造和翻转构造之间移动。假体心脏瓣膜400(在本文中也称为“假体瓣膜”或“瓣膜”)可以是例如假体二尖瓣。瓣膜400包括具有外框架420的外框架组件和具有内框架450的内瓣膜组件。外框架420和内框架450均形成为管状结构。瓣膜400也可以包括其他特征，例如以上关于图1A-7D描述的那些特征。为了说明的目的，关于8A-8B仅讨论了内框架450和外框架420。应当理解，上面关于图1A-7D所述的瓣膜的各种特性和特征可以应用于瓣膜400。
外框架420和内框架450可以在围绕内框架450的周边和外框架420的周边布置的多个联接接头446处联接在一起，如上面关于瓣膜300所述。联接接头446可以允许外框架420相对于内框架450移动，如上面关于瓣膜300所述。例如，外框架420可以在相对于内框架450的第一位置(图8A)和相对于内框架450的第二位置(图8B)之间移动。在第一位置中，外框架420的敞开的自由端部部分416在与内框架450的敞开的自由端部部分447相同的方向上布置(参见图8A)。在第二位置中，外框架420相对于内框架450翻转，使得外框架420的自由端部部分416此时在与内框架450的自由端部部分447相反的方向上布置(参见图8B)。
如上面关于瓣膜100和200所述，在内瓣膜组件的外表面和外框架组件的内表面之间形成锥形的环形空间或囊袋485(也称为“心房囊袋”)，其通向瓣膜400的心房端。当瓣膜400布置在自体心脏瓣膜的瓣环中时，来自心房的血液可以移动进入和离开囊袋485。血液可以凝结，以形成血栓。为了增强凝结，组织向内生长到瓣膜400的表面中并产生其他益处，可以通过囊袋闭合件480(也称为“心房囊袋闭合件”)覆盖或封闭囊袋485。囊袋闭合件480围绕内框架450的周边和外框架420的周边联接，以便在瓣膜400的心房端处封闭囊袋485。如图8A和8B中所示，囊袋闭合件480在联接部分482处联接到内框架450并且在联接部分483处联接到外框架420。囊袋闭合件480可以由一个连续材料段或材料部分形成，或者可以用联接在一起的两个或更多个材料部分或材料段形成。例如，在一些实施例中，囊袋闭合件480可以由用缝线或其他合适的联接方法缝合在一起的三个材料部分或材料段形成。
如上所述，囊袋闭合件480可以至少部分地由任何合适的材料形成，其足够多孔以允许血液(特别是包括红血细胞)进入囊袋485，但不是多孔到非期望地允许大的血栓离开囊袋485的程度。例如，囊袋闭合件480可以至少部分地由具有小于160μ、优选在90μ至120μ之间的孔的材料形成。在该实施例中，囊袋闭合件480可以至少部分地由具有期望孔隙率的编织镍钛诺材料(或编织管状镍钛诺材料)形成。编织镍钛诺材料也提供了期望的可拉伸性、挠性或可变形性以适应外框架420在相对于内框架450的第一位置和相对于内框架450的第二翻转位置之间的移动。例如，编织镍钛诺材料可以具有形状记忆性质，其允许囊袋闭合件480变形和/或拉伸，并且随后在释放时恢复到原始形状或原始构造。
如图8A中所示，当外框架420处于相对于内框架450的第一位置时，囊袋闭合件480布置成第一构造。如图8B中所示，当外框架420处于相对于内框架450的第二位置(即，翻转)时，囊袋闭合件480布置成第二构造。更具体地，当外框架420移动到外框架420相对于内框架420翻转的第二位置时，囊袋闭合件480的材料和结构使囊袋闭合件480能够与外框架420一起拉伸，如图8B中所示。换句话说，如图8B中所示，囊袋闭合件480在其联接到内框架的位置(即，联接部分482)与其联接到外框架的位置(即，联接部分483)之间拉伸或伸长到比当外框架420处于如图8A中所示的第一位置时更大的长度。当外框架420相对于内框架450移回到第一位置时，囊袋闭合件480可以呈现其第一构造，如图8A中所示。
图9A和9B示出了包括囊袋闭合件的假体心脏瓣膜的另一实施例，所述囊袋闭合件可以适应瓣膜在扩张构造以及用于在心脏的左心房内递送和部署的翻转构造之间移动。假体心脏瓣膜500(在本文中也称为“假体瓣膜”或“瓣膜”)可以是例如假体二尖瓣。瓣膜500包括具有外框架520的外瓣膜组件和具有内框架550的内瓣膜组件。外框架520和内框架550均形成为管状结构。瓣膜500也可以包括其他特征，例如上面关于图1A-7D描述的那些特征。为了说明的目的，关于8A-8B仅讨论内框架550和外框架520。应当理解，上面关于图1A-7D所述的瓣膜的各种特性和特征可以应用于瓣膜500。
与前面的实施例一样，外框架520和内框架550可以在围绕内框架550的周边和外框架520的周边布置的多个联接接头546处联接在一起，正如上面关于瓣膜300所述。联接接头546可以允许外框架520相对于内框架550移动，正如上面关于瓣膜300所述。例如，外框架520可以在相对于内框架550的第一位置(图9A)和相对于内框架550的第二位置(图9B)之间移动。在第一位置中，外框架520的敞开的自由端部部分516与内框架550的敞开的自由部端部分547沿着相同的方向布置(参见图9A)。在第二位置中，外框架520相对于内框架550翻转，使得外框架520的自由端部部分516此时与内框架550的自由端部部分547沿着相反的方向布置(参见图9B)。
如上面关于瓣膜100和200所述，在内瓣膜组件的外表面和外框架组件的内表面之间形成锥形的环形空间或囊袋585(也称为“心房囊袋”)，其通向瓣膜500的心房端。当瓣膜500布置在自体心脏瓣膜的瓣环中时，来自心房的血液可以移动进入和离开囊袋585。血液可以凝结，以形成血栓。为了增强凝结，组织向内生长到瓣膜500的表面中并产生其他益处，可以通过囊袋闭合件580(也称为“心房囊袋闭合件”)覆盖或封闭囊袋585。
在该实施例中，囊袋闭合件580包括联接到第二部分586的第一部分584。如图9B的细节图中所示，第一部分584包括在联接接头587处联接到外框架520的第一端部以及在联接接头588处联接到第二部分586的第二端部。第二部分586具有在联接接头588处联接到第一部分584的第一端部以及在联接接头589处联接到外框架520的第二端部。因此，在该实施例中，囊袋闭合件580仅联接到外框架520。囊袋闭合件580可以在瓣膜500的心房端处封闭囊袋。囊袋闭合件580的第一部分584和第二部分586均可以形成为一个连续材料段或材料段部分，或者可以形成为具有例如用缝线或另一合适的联接方法联接在一起的两个或更多个材料部分或材料段。
如上所述，囊袋闭合件580可以至少部分地由任何合适的材料形成，其足够多孔以允许血液(特别是包括红血细胞)进入囊袋585，但不是多孔到非期望地允许大的血栓离开囊袋585的程度。例如，囊袋闭合件580可以至少部分地由具有小于160μ、优选在90μ至120μ之间的孔的材料形成。在该实施例中，囊袋闭合件580的第一部分584可以至少部分地由具有小于160μ、优选在90μ至120μ之间的孔的机织或针织聚酯织物形成。囊袋闭合件580的第二部分586可以用管状编织镍钛诺材料形成，正如上面关于瓣膜400所述，其可以提供期望的拉伸性或挠性或可变形性以适应外框架520在相对于内框架550的第一位置和相对于内框架550的第二翻转位置之间移动。
如图9A中所示，当外框架520处于相对于内框架550的第一位置时，囊袋闭合件580布置成第一构造。如图9B中所示，当外框架520处于相对于内框架550的第二位置(即，翻转)时，囊袋闭合件580布置成第二构造。更具体地，当外框架520移动到外框架520相对于内框架520翻转的第二位置时，囊袋闭合件580的第二部分586的材料和结构使囊袋闭合件580能够与外框架520一起拉伸，如图9B中所示。换句话说，如图9B中所示，囊袋闭合件580的第二部分586可以在其联接到囊袋闭合件580的第一部分584的位置(即，联接接头588)和其联接到外框架520的位置(即，联接部分589)之间拉伸或伸长到比当外框架520处于如图9A中所示的第一位置时更大的长度。当外框架520移动到相对于内框架550的第二位置(即，翻转)时，囊袋闭合件580的第一部分584不拉伸。当外框架520移回到相对于内框架550的第一位置时，囊袋闭合件580可以呈现其第一构造，如图9A中所示。
在假体心脏瓣膜的一些实施例中，除了上述用于先前实施例的外覆盖物(例如，外覆盖物160)之外，还可以将附加的材料层附接到内框架。附加的材料层可以附接到瓣膜的内框架的内表面或外表面。例如，附加的材料层可以附接到内框架的内表面以及瓣膜的瓣叶的外侧。换句话说，外覆盖物可以布置在瓣叶和附加的材料层之间，并且所有的三个部件(瓣叶、外覆盖物和附加的材料层)都布置在瓣膜的内框架的内侧上。附加的材料层可能是合乎需要的，用以防止瓣叶的腹部区域的可能翻滚。例如，当能够导致瓣叶闭合的背压也向瓣叶的腹部区域施加压力时，可能发生这样的翻滚，潜在地会导致它们朝着外框架凸出到囊袋区域中。附加的材料层可以由各种不同的材料组成。图10A-10C示出了包括这样的材料层625的假体心脏瓣膜600。在该实施例中，材料层625布置为圆柱体，其从内框架650的基部622至内框架650的顶端或心房端624覆盖内框架650。如图10A和10B中所示，瓣膜600包括瓣叶670。如图10C中所示，圆柱形布置的材料层625桥接框架650的顶部624。在替代的实施例中，材料层可以构造成遵循内框架的形状，如图10D中所示。在该实施例中，瓣膜600'包括基本上遵循或符合内框架650的形状的材料层625'。换句话说，材料层625'跨接在内框架650的框架部分之间。在一些实施例中，材料层625、625'可以是例如聚酯材料。
尽管上面已描述了各种实施例，但是应当理解，它们仅作为示例给出而并不是限制性的，并且因此可以进行形式和/或细节上的各种改变。本文所述的装置和/或方法的任何部分能够以任何合适的组合方式进行组合，除非另有明确表述本文所述的实施例可以包括所描述的不同实施例的功能、部件和/或特征的各种组合和/或子组合。
在上述方法和指明了某些事件以某种顺序发生的情况下，可以修改某些事件和/或流程模式的排序。另外，某些事件在可行的情况下可以在并行处理中同时执行，也可以顺序地执行。

Claims (31)

1.一种假体心脏瓣膜，其包括：
内框架，所述内框架具有敞开的端部部分；
外框架，所述外框架具有敞开的端部部分并且联接到所述内框架，以使得所述外框架和所述内框架限定在所述内框架的一部分和所述外框架的一部分之间的环形区域，所述环形区域朝着所述外框架的敞开的端部部分和所述内框架的敞开的端部部分敞开，
所述外框架能够在相对于所述内框架的第一位置和相对于所述内框架的第二位置之间移动，在所述第一位置中所述外框架处于偏压扩张构造，在所述第二位置中所述外框架相对于所述内框架翻转；以及
可拉伸的囊袋覆盖物，所述可拉伸的囊袋覆盖物联接到所述内框架并且联接到所述外框架，以使得所述环形空间在所述内框架的敞开的端部部分和所述外框架的敞开的端部部分之间由所述囊袋覆盖物覆盖，
所述可拉伸的囊袋覆盖物构造成用以在第一构造和第二位置之间移动，在所述第一构造中当所述外框架处于相对于所述内框架的第一位置时所述囊袋覆盖物具有第一长度，在所述第二位置中当所述外框架处于相对于所述内框架的第二位置时所述囊袋覆盖物具有大于所述第一长度的第二长度。
2.根据权利要求1所述的假体心脏瓣膜，其中当所述假体心脏瓣膜布置在患者的心脏内时，所述囊袋覆盖物、所述内框架和外框架共同限定囊袋，血栓能够在所述囊袋中形成并且被保持在所述囊袋中。
3.根据权利要求1所述的假体心脏瓣膜，其中当所述外框架处于所述第一位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分均沿着相同的方向布置，当所述外框架处于所述第二位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分沿着相反的方向布置。
4.根据权利要求1所述的假体心脏瓣膜，其中所述外框架在多个联接接头处联接到所述内框架，所述内框架包括与所述内框架的敞开的端部部分相对的系绳联接部分，
当所述外框架处于所述第一位置时，所述联接接头布置在所述外框架的敞开的端部部分和所述内框架的系绳联接部分之间，
当所述外框架位于所述第二位置时，所述联接接头布置在所述内框架的敞开的端部部分和所述外框架的敞开的端部部分之间。
5.根据权利要求1所述的假体心脏瓣膜，其中所述囊袋覆盖物由具有孔隙率的材料形成，所述孔隙率足够大以允许红血细胞穿过所述囊袋闭合件进入所述囊袋，并且所述孔隙率足够小以防止由红血细胞形成的血栓从所述囊袋穿过所述囊袋闭合件。
6.根据权利要求1所述的假体心脏瓣膜，其中所述囊袋覆盖物由编织的镍钛诺材料形成。
7.根据权利要求1所述的假体心脏瓣膜，其中所述囊袋覆盖物由形状记忆材料形成，所述形状记忆材料构造成从偏压构造移动到伸长构造并且返回到所述偏压构造。
8.根据权利要求1所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
围绕所述外覆盖物布置的圆柱形材料层，所述圆柱形材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
9.根据权利要求11所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
布置在所述外覆盖物上并且与所述内框架的形状一致的材料层，所述材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
10.一种假体心脏瓣膜，其包括：
内框架，所述内框架具有敞开的端部部分；
外框架，所述外框架具有敞开的端部部分并且联接到所述内框架，以使得所述外框架和所述内框架限定在所述内框架的一部分和所述外框架的一部分之间的环形区域，所述环形区域朝着所述外框架的敞开的端部部分和所述内框架的敞开的端部部分敞开，
所述外框架能够在相对于所述内框架的第一位置和相对于所述内框架的第二位置之间移动，在所述第一位置中所述外框架处于偏压扩张构造，在所述第二位置中所述外框架相对于所述内框架翻转；以及
囊袋覆盖物，所述囊袋覆盖物具有联接到第二部分的第一部分，所述第一部分在第一联接接头处联接到所述外框架，所述第二部分在第二联接接头处联接到所述外框架，所述囊袋覆盖物封闭所述环形空间，
所述囊袋覆盖物构造成用以在第一构造和第二位置之间移动，在所述第一构造中当所述外框架处于相对于所述内框架的第一位置时所述囊袋覆盖物的第二部分具有第一长度，在所述第二位置中当所述外框架处于相对于所述内框架的第二位置时所述囊袋覆盖物的第二部分具有大于所述第一长度的第二长度。
11.根据权利要求10所述的假体心脏瓣膜，其中当所述假体心脏瓣膜布置在患者的心脏内时，所述囊袋覆盖物、所述内框架和外框架共同限定囊袋，血栓能够在所述囊袋中形成并且被保持在所述囊袋中。
12.根据权利要求10所述的假体心脏瓣膜，其中当所述外框架处于所述第一位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分均沿着相同的方向布置，当所述外框架处于所述第二位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分沿着相反的方向布置。
13.根据权利要求10所述的假体心脏瓣膜，其中所述外框架在多个联接接头处联接到所述内框架，所述内框架包括与所述内框架的敞开的端部部分相对的系绳联接部分，
当所述外框架处于所述第一位置时，所述联接接头布置在所述外框架的敞开的端部部分和所述内框架的系绳联接部分之间，
当所述外框架位于所述第二位置时，所述联接接头布置在所述内框架的敞开的端部部分和所述外框架的敞开的端部部分之间。
14.根据权利要求10所述的假体心脏瓣膜，其中所述囊袋闭合件由具有孔隙率的材料形成，所述孔隙率足够大以允许红血细胞穿过所述囊袋闭合件进入所述囊袋，并且所述孔隙率足够小以防止由红血细胞形成的血栓从所述囊袋穿过所述囊袋闭合件。
15.根据权利要求10所述的假体心脏瓣膜，其中所述囊袋覆盖物由编织的镍钛诺材料形成。
16.根据权利要求10所述的假体心脏瓣膜，其中所述囊袋覆盖物由形状记忆材料形成，所述形状记忆材料构造成从偏压构造移动到伸长构造并且返回到所述偏压构造。
17.根据权利要求10所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
围绕所述外覆盖物布置的圆柱形材料层，所述圆柱形材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
18.根据权利要求10所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
布置在所述外覆盖物上并且与所述内框架的形状一致的材料层，所述材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
19.一种假体心脏瓣膜，其包括：
外框架组件，所述外框架组件具有构造成布置在心脏的心房中的心房端和相对的心室端；
内瓣膜组件，所述内瓣膜组件布置在所述外框架组件内并联接到所述外框架组件，并且具有构造成布置在心脏的心房内的心房端和相对的心室端，所述内瓣膜组件和所述外框架组件在其间限定环形区域，所述内瓣膜组件和所述外框架组件构造成基本上防止血流在其间通过所述环形区域，
所述外框架组件能够在相对于所述内瓣膜组件的第一位置和相对于所述内瓣膜组件的第二位置之间移动，在所述第一位置中所述外框架组件处于偏压扩张构造，在所述第二位置中所述外框架相对于所述内框架翻转；以及
囊袋闭合件，所述囊袋闭合件联接在所述外框架组件和所述内瓣膜组件之间并且与其一起封闭所述环形空间的一部分，形成血栓保持囊袋，所述囊袋闭合件的至少一部分由具有孔隙率的材料形成，所述孔隙率足够大以允许红血细胞通过所述囊袋闭合件进入所述囊袋，并且所述孔隙率足够小以防止由红血细胞形成的血栓从所述囊袋穿过所述囊袋闭合件。
20.根据权利要求19所述的假体心脏瓣膜，其中所述外框架组件的心房端是所述外框架组件的敞开的端部部分，所述内瓣膜组件的心房端是所述内瓣膜组件的敞开的端部部分，
当所述外框架组件处于所述第一位置时，所述外框架组件的敞开的端部部分和所述内瓣膜组件的敞开的端部部分均沿着相同的方向布置，当所述外框架组件处于所述第二位置时，所述外框架组件的敞开的端部部分和所述内瓣膜组件的敞开的端部部分沿着相反的方向布置。
21.根据权利要求19所述的假体心脏瓣膜，其中所述外框架组件在多个联接接头处联接到所述内瓣膜组件，
当所述外框架处于所述第一位置时，所述联接接头布置在所述外框架的心房端和所述内瓣膜组件的心室端之间，
当所述外框架处于所述第二位置时，所述联接接头布置在所述内瓣膜组件的心房端和所述外框架组件的心房端之间。
22.根据权利要求19所述的假体心脏瓣膜，其中所述囊袋覆盖物由编织的镍钛诺材料形成。
23.根据权利要求19所述的假体心脏瓣膜，其中所述囊袋覆盖物由形状记忆材料形成，所述形状记忆材料构造成从偏压构造移动到伸长构造并且返回到所述偏压构造。
24.根据权利要求19所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
围绕所述外覆盖物布置的圆柱形材料层，所述圆柱形材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
25.根据权利要求19所述的假体心脏瓣膜，其还包括：
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
布置在所述外覆盖物上并且与所述内框架的形状一致的材料层，所述材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
26.一种假体心脏瓣膜，其包括：
内框架，所述内框架具有敞开的端部部分；
外框架，所述外框架具有敞开的端部部分并且联接到所述内框架，以使得所述外框架和所述内框架限定在所述内框架的一部分和所述外框架的一部分之间的环形区域，所述环形区域朝着所述外框架的敞开的端部部分和所述内框架的敞开的端部部分敞开，
所述外框架能够在相对于所述内框架的第一位置和相对于所述内框架的第二位置之间移动，在所述第一位置中所述外框架处于偏压扩张构造，在所述第二位置中所述外框架相对于所述内框架翻转；
布置在所述内框架上的外覆盖物；
布置在所述内框架的内部中的瓣叶；以及
布置在所述外覆盖物上并且与所述内框架的形状一致的材料层，所述材料层构造成防止所述瓣叶的腹部区域翻滚到所述环形区域中。
27.根据权利要求26所述的假体心脏瓣膜，其中所述材料层包括聚酯材料。
28.根据权利要求26所述的假体心脏瓣膜，其中布置在所述内框架的外部上的所述外覆盖物包括生物组织，所述材料层包括聚酯材料。
29.根据权利要求26所述的假体心脏瓣膜，其还包括：
布置在所述外框架的内部上的内覆盖物；以及
布置在所述外框架的至少一部分的外部上的外覆盖物。
30.根据权利要求26所述的假体心脏瓣膜，其中当所述外框架处于所述第一位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分均沿着相同的方向布置，当所述外框架处于所述第二位置时，所述外框架的敞开的端部部分和所述内框架的敞开的端部部分沿着相反的方向布置。
31.根据权利要求26所述的假体心脏瓣膜，其中所述外框架在多个联接接头处联接到所述内框架，所述内框架包括与所述内框架的敞开的端部部分相对的系绳联接部分，
当所述外框架处于所述第一位置时，所述联接接头布置在所述外框架的敞开的端部部分和所述内框架的系绳联接部分之间，
当所述外框架位于所述第二位置时，所述联接接头布置在所述内框架的敞开的端部部分和所述外框架的敞开的端部部分之间。
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