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CN108814772B - 用于假体心脏瓣膜的血栓管理和结构顺应特征 - Google Patents

用于假体心脏瓣膜的血栓管理和结构顺应特征 Download PDF

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Publication number
CN108814772B
CN108814772B CN201810358154.6A CN201810358154A CN108814772B CN 108814772 B CN108814772 B CN 108814772B CN 201810358154 A CN201810358154 A CN 201810358154A CN 108814772 B CN108814772 B CN 108814772B
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Prior art keywords
valve
outer frame
assembly
prosthetic heart
frame assembly
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CN201810358154.6A
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CN108814772A (zh
Inventor
M·克里斯蒂安松
C·佩林
Z·特格尔斯
C·埃克瓦尔
R·维德伦德
S·梅
M·伊文思
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Tendyne Holdings Inc
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Tendyne Holdings Inc
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Priority claimed from US14/155,535 external-priority patent/US20140379076A1/en
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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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    • 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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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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

一种假体心脏瓣膜能够包括：外部支撑组件；内部瓣膜组件，在外部支撑组件和内部瓣膜组件之间限定环形空间；以及囊袋封闭件，所述囊袋封闭件界定所述环形空间以形成囊袋，血栓能够形成于和保持在囊袋中。可选地或附加地，外部支撑组件和内部瓣膜组件能够在外部支撑组件和内部瓣膜组件的心室端处被联接，其中，外部支撑组件在中心的瓣环部分中比在心室端处在环箍压缩方面相对更顺应，使得假体瓣膜能够牢固地座置在瓣环中，同时对内部瓣膜组件施加的能够降低瓣叶性能的负荷最小。

Description

用于假体心脏瓣膜的血栓管理和结构顺应特征
本申请是发明名称为“用于假体心脏瓣膜的血栓管理和结构顺应特征”、国际申请日为2014年6月25日、国际申请号为PCT/US2014/044047、国家申请号为201480035996.8的发明专利申请的分案申请。
相关申请的交叉引用
本申请是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全文引用而并入本文。
背景技术
假体心脏瓣膜(包括用于插入房室瓣膜(三尖瓣和二尖瓣)中的假体心脏瓣膜)易于出现各种问题，仅作为举例地包括以下问题：自体瓣环内的瓣膜的铰接和密封不足、由于不良心房引流引起的肺水肿、围绕安装假体瓣膜的瓣周漏、自体瓣环内的假体瓣膜缺少良好配合、心房组织糜烂、镍钛诺结构的过度磨损、在二尖瓣环的后侧干涉主动脉、可定制性不足、以及血栓形成。因此，仍然需要能够解决这些问题中的一部分或全部问题的假体心脏瓣膜。
发明内容
一种假体心脏瓣膜能够包括：外部支撑组件；内部瓣膜组件，在外部支撑组件和内部瓣膜组件之间限定环形空间；以及囊袋封闭件，所述囊袋封闭件界定所述环形空间以形成囊袋，血栓能够形成于和保持在囊袋中。可选地或附加地，一种假体心脏瓣膜能够包括外部支撑组件和内部瓣膜组件，所述外部支撑组件和内部瓣膜组件能够在外部支撑组件和内部瓣膜组件的心室端处被联接，其中，外部支撑组件在中心的瓣环部分中比在心室端处在环箍压缩方面相对更顺应，使得假体瓣膜能够牢固地座置在瓣环中，同时对内部瓣膜组件施加的能够降低瓣叶性能的负荷最小。
附图说明
图1A和1B是根据一个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-C是图1A和1B的假体心脏瓣膜的内部瓣膜组件的示意图。
图3是根据另一实施例的假体心脏瓣膜的俯视图。
图4是根据另一实施例的假体心脏瓣膜的俯视图。
图5是根据另一实施例的假体心脏瓣膜的一部分的透视侧视图。
图6是根据另一实施例的假体心脏瓣膜系统的分解图。
图7-9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10是处于未膨胀配置的、图7-9的瓣膜的内部框架的打开和平展视图。
图11和12分别是处于膨胀配置的、图10的内部框架的侧视图和仰视图。
图13是处于未膨胀配置的、图7-9的瓣膜的外部框架的打开和平展视图。
图14和15分别是处于膨胀配置的、图13的外部框架的侧视图和俯视图。
图16-18是图10-12的内部框架和图13-15的外部框架的组件的侧视图、前视图和俯视图。
图19是图7-9的瓣膜的外部框架组件的内部和外部覆盖物的织物型式的平面图。
图20是图7-9的瓣膜的内部瓣膜组件的瓣叶和外部覆盖物的织物型式的平面图。
图21和22是根据另一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23-25是根据另一实施例的假体心脏瓣膜的俯视图和透视图。
图26是根据另一实施例的假体心脏瓣膜系统的分解图。
图27和28是根据另一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29A-D是根据另一实施例的假体心脏瓣膜的刚度分布的示意图。
具体实施方式
在图1A和1B中示出了假体心脏瓣膜100的示意图。假体心脏瓣膜100设计成替换损坏或病变的自体心脏瓣膜例如二尖瓣。瓣膜100包括外部框架组件110和联接到外部框架组件的内部瓣膜组件140。
尽管未在图1A和1B的外部框架组件110的示意图中单独地示出，但是外部框架组件110可以由外部框架120形成，所述外部框架在其外表面的全部或一部分上由外部覆盖物130覆盖，并且在其内表面的全部或一部分上由内部覆盖物132覆盖。
外部框架120能够为假体心脏瓣膜100提供若干功能，包括用作主要结构、用作锚固机构和/或将瓣膜锚固到自体心脏瓣膜装置的独立锚固机构所用的附连点、用作承载内部瓣膜组件140的支撑件、和/或用作抑制假体心脏瓣膜100和自体心脏瓣膜装置之间的瓣周漏的密封件。
外部框架120优选地形成为使得它能够变形(压缩和/或膨胀)，并且当释放时返回到其初始(未变形)的形状。为了实现这一点，外部框架120优选地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
Figure BDA0001635250730000031
是尤其有用的，原因是它能够被处理成奥氏体、马氏体或超弹性体。可以使用其它的形状记忆合金，例如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。
外部框架120优选地通过激光切割
Figure BDA0001635250730000041
的薄壁管而形成。激光切割在
Figure BDA0001635250730000042
薄管中形成规则的切口。管能够径向地膨胀，放置在期望形状的模具或心轴上，加热到马氏体温度，然后进行淬火。以该方式处理的框架将形成开放式格栅框架结构，并且可以在外部框架120的心房端部分126处具有扩口端或端口。外部框架120因此具有形状记忆性质并且在标定的温度下将易于恢复到记忆形状。可选地，外部框架120可以由编织线或其它合适的材料构造。
在图2A-2C中更详细地、示意性地示出了内部瓣膜组件140。内部瓣膜组件140能够包括内部框架150、外部覆盖物160和瓣叶170。在图2A示意性地示出的简化形式中，内部框架150包括支撑外部覆盖物160和瓣叶170的六个轴向柱或框架构件。瓣叶170沿着其中的三个柱(在图2A中示出为连合柱152)被附连，并且外部覆盖物160附连到另外三个柱(图2A中的154)，并且可选地附连到连合柱152。在图2A示意性地示出的简化形式中，外部覆盖物160和瓣叶170中的每一者由在它们的上端或心房端处联结在一起的大致矩形的片材形成。外部覆盖物160的下方的心室端可以联结到外部框架组件110的内部覆盖物132(在图2A中未示出)，并且瓣叶170的下方的心室端可以形成自由边缘，但还是联接到连合柱152的下端。
如图2B和2C所示，瓣叶170在打开配置(图2B)和闭合配置(图2C)之间可移动，在所述闭合配置中瓣叶以密封抵接的方式合紧或会合。
在下端或心室端，瓣叶170可以具有比外部覆盖物160更小的周长。因此，在连合柱152之间的瓣叶的自由下缘(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”)与外部覆盖物160的下缘径向地间隔开。该径向间隔便于瓣叶从图2B的打开位置移动到图2C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能够捕捉到腹部的自由边缘并且推动瓣叶闭合。
外部框架120的外部覆盖物130和内部覆盖物132、外部覆盖物160和瓣叶170可以由任意合适的材料或材料的组合形成。在一些实施例中，组织可选地是生物组织例如来自动物(如猪)的心脏瓣膜的化学性稳定的组织，或者是动物的心包组织例如牛(牛心包)或羊(羊心包)或猪(猪心包)或马(马心包)。优选地，组织是牛心包组织。合适的组织的例子包括在产品
Figure BDA0001635250730000051
和
Figure BDA0001635250730000052
中使用的组织，所有这些产品目前都在外科手术中使用，并且其市场来源通常是从年龄小于30个月的牲畜获取。可选地，瓣叶170能够可选地由心包组织或小肠粘膜下组织制成。
合成材料(如聚氨酯或聚四氟乙烯)也可以用于瓣叶170。在设想将薄的耐用合成材料例如用于外部覆盖物130或内部覆盖物132的情况下，能够可选地使用合成聚合物材料例如膨体聚四氟乙烯或聚酯。其它合适的材料能够可选地包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯、以及超高分子量聚乙烯。另外的生物相容的聚合物能够可选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯、以及使用它们的嵌段共聚物。
在另一实施例中，瓣叶170能够可选地具有已用抗凝剂(例如但不限于固定肝素)进行处理(或与之反应)的表面。这样的当前可用的肝素化聚合物是已知的并且是本领域普通技术人员可获得的。
如图1A、1B和2A中所示，内部瓣膜组件140可以为大致圆柱形，并且外部框架组件110可以是渐缩的，从下方的心室部分112(在此它联接到内部瓣膜组件140)处的较小直径(略大于内部瓣膜组件140的外径)延伸到较大直径的心房部分116，并且中间直径的瓣环部分114介于心房部分和心室部分之间。
渐缩的环形空间或囊袋185由此形成于内部瓣膜组件140的外表面和外部框架组件110的内表面之间，开向瓣膜组件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，来自心房的血液能够流入和流出囊袋185。血液能够凝结，形成血栓，并且血栓能够在心脏的循环泵送期间通过血液的流动冲刷，这是不合需要的。为了抑制血栓的这样的冲刷，并且增强凝结，组织向内生长到瓣膜100的表面中，并且产生其它益处，囊袋能够由囊袋封闭件180覆盖或封闭。
囊袋封闭件180能够至少部分地由任意合适的材料形成，所述材料的孔隙率足以允许血液(特别地包括红血细胞)进入囊袋185，但是孔隙率不足以允许不合需要的大血栓离开囊袋185，或者不足以允许冲刷形成于囊袋185中的血栓。例如，囊袋封闭件180可以至少部分地由具有小于160μ并且优选地在90μ到120μ之间的孔的梭织或针织聚酯织物形成。不必使整个囊袋封闭件180均由具有相同孔隙率的相同材料形成。例如，囊袋封闭件180的一些部分可以由孔隙率较小或者不透血液的材料形成，并且其它部分由上述孔隙率范围的材料形成。也可以设想外部框架组件110或内部瓣膜组件140的一部分能够形成有与囊袋180连通的孔，所述孔由具有期望孔隙率的材料形成的封闭件覆盖，由此提供血液可以通过其进入、但是防止血栓离开心房囊袋185的另一路径。
内部瓣膜组件110的外表面和/或外部框架组件140的内表面不需要如图1A和1B中示意性图示的那样在横截面上为圆形，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，并且可以不是连续的，而是可以形成两个或更多个流体隔离的、部分环形的体积。类似地，囊袋封闭件180不需要如图1A和1B中示意性图示的那样成形为具有恒定宽度的环，而是可以成形为变化宽度的连续环并且具有更复杂的连续形状，或者可以形成多个离散的部段。
囊袋封闭件180用于阻拦和/或减慢囊袋185内的血液的流动，减小血液动力冲刷并且增加在囊袋185中形成的血栓。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，使瓣膜100在自体心脏瓣膜中进一步稳定。形成内部瓣膜组件140的外部覆盖物的材料也可以被硬化或刚化，以为瓣叶170提供更好的支撑。而且，大量血栓填充的囊袋185能够用作对内部瓣膜组件140的罐封，进一步稳定瓣膜组件。内部瓣膜组件140的更大的稳定性能够提供瓣叶170的更可靠合紧，并且因此提供更有效的性能。在外部框架组件已安装在自体瓣膜装置中并且挠性地顺应自体瓣膜装置之后，大量的血栓也能够稳定外部框架组件110。这能够提供假体心脏瓣膜100和自体瓣膜装置之间的更有效的密封，并且减小瓣周漏。
图1A-2C中示意性地示出的假体心脏瓣膜的一种可行的实施方式是图3的俯视图中示出的假体心脏瓣膜200。假体心脏瓣膜200包括外部框架组件210和联接到外部框架组件的内部瓣膜组件240。
外部框架组件210包括外部框架220，所述外部框架在其外表面的全部或一部分上由外部覆盖物230(不可见)覆盖，并且在其内表面的全部或一部分上由内部覆盖物232覆盖。
内部瓣膜组件240包括内部框架250、外部覆盖物260(不可见)和瓣叶270。内部框架250包括支撑外部覆盖物260和瓣叶270的六个轴向柱或框架构件。内部瓣膜组件240可以为大致圆柱形，外部框架组件210可以是渐缩的，从下方的心室部分(在此它联接到内部瓣膜组件240)处的较小直径(略大于内部瓣膜组件240的外径)延伸到较大直径的心房部分，并且中间直径的瓣环部分介于心房部分和心室部分之间。
渐缩的环形空间或囊袋285(例如心房血栓形成密封囊袋)由此形成于内部瓣膜组件240的外表面和外部框架组件210的内表面之间，开向瓣膜组件200的心房端。囊袋封闭件280例如可以由线的圆形件或Halo电极形成，具有可渗透的网状织物或组织，其被缝合并由此连接到内部框架250和/或瓣叶170。内部框架250具有内部线框结构(例如，由镍钛诺线制造)，其支撑被缝合到内部框架250的瓣叶270并且用作瓣膜。图3中的内部框架250包括在其开口端联结以形成接合部的三个U形线部件。瓣叶270被缝合到这些部件以形成铰接瓣叶170，所述铰接瓣叶170构建并且用作假体瓣膜(例如，假体三尖瓣；假体二尖瓣；假体主动脉瓣等)。
而且，内部框架250具有用于附连拴系组件290(未示出)的(拴系)附连孔211(未示出)。拴系组件290连接到心外膜固定垫254(未示出)。
在操作中，内部瓣膜组件240布置并且固定在外部框架组件210中。外部框架组件210也可以在各种实施例中具有外部支架组织材料。外部框架组件210包括具有套环盖248的铰接套环246。铰接套环246具体地成形为用以解决由自体结构引起的泄漏问题。特别地，套环246包括A2段247、P2段249、以及两个连合段即A1-P1段251和A3-P3段253。套环246也可以在优选实施例中具有A2段的缩短或平展或D形的部段262以便适应和解决左心室流出道(LVOT)阻塞问题。
在操作中，可以使用导管输送技术部署假体心脏瓣膜200(例如，作为假体二尖瓣)。假体心脏瓣膜200在窄导管内被压缩并且与预先附连的拴系组件290一起被输送到自体瓣膜的环形区域(例如，左心房)。在此，瓣膜200被推出导管，由此弹开成其预成形的功能形状而不需要手动膨胀(例如，使用内部球囊导管的手动膨胀)。当瓣膜200被牵拉就位时，外部框架组件210座置在自体二尖瓣环中，让铰接套环246接合心房底部并且防止穿出(其中瓣膜200被牵拉到心室中)。在这样的实施例中，不必像在现有的假体尝试中所教导的那样切除自体瓣叶。而是，自体瓣叶能够用于提供围绕外部框架组件210的张紧和/或密封功能。有利的是非对称地部署瓣膜200以便解决LVOT问题，其中，非适应性的假体瓣膜压靠瓣膜(例如，二尖瓣)的A2前段并且关闭通过主动脉的血流，主动脉在解剖学上位于二尖瓣环的A2段的紧后方。因此，D形部段262部署成大致紧邻/接触A2段，原因是平展的D形部段262结构较小并且具有更竖直的轮廓(更接近平行于外部框架组件212的纵向轴线)并且由此提供作用于A2段的更小压力。一旦瓣膜200正确地座置，拴系组件290可以通过左心室的心尖区域伸出并且利用心外膜垫254或类似的缝合锁定附连机构(未示出)固定。
在可选实施例中，拴系组件290位于外部框架组件210上，其相应地具有用于将拴系组件290附连到心外膜固定垫254的(拴系)附连孔213。
图4是示出了没有囊袋封闭件380的假体心脏瓣膜300的另一实施例的俯视图或心房视图。图4示出了在其开口端处联结以形成接合部302的内部框架350的三个U形线部件的接合尖端302的顶部。瓣叶370缝合到这些部件以形成铰接瓣叶370，所述铰接瓣叶370构建并且用作假体瓣膜(例如，假体三尖瓣，假体二尖瓣，假体主动脉瓣等)。在套环的平面下方示出了血栓形成囊袋385。图4示出了竖直的A2段347、P2段349、以及连合的A1-P1段351和A3-P3段353。图4示出了在部署时血液将如何填充瓣膜300的内部瓣膜组件340和外部框架组件310之间的空隙或间隙385。这些血液建立暂时的流体密封，其聚集在该空间中并且针对伴随与心脏收缩和心脏舒张相关的心房内压力和心室内压力的泄漏诱导力提供压力缓冲。而且，图4提供套环346的图示，在一些实施例中所述套环可以包括A2段的缩短或平展或D形的部段362以便适应和解决左心室流出道(LVOT)阻塞问题。
图5是本文中给出的自膨胀预配置可压缩的经导管假体心血管瓣膜400的P2区域447和A3-P3区域453的透视侧视图，所述瓣膜包含自膨胀内部瓣膜组件440作为子部件。瓣膜400还包括外部框架组件410作为子部件。外部框架组件410和内部瓣膜组件440共同限定血栓形成囊袋485。图5示出了在其开口端处联结以形成接合部402的内部框架450的三个U形线部件中的一个。瓣叶470缝合到这些部件以形成铰接瓣叶470，所述铰接瓣叶470构建并且用作假体瓣膜。在套环446的主要部分的平面稍下方示出了血栓形成囊袋485，所述主要部分不包括竖直的A2段447、P2段449以及连合的A1-P1段451(未示出)和A3-P3段453。图5示出了在部署时血液将如何在瓣膜400的A3-P3段453的区域填充内部瓣膜组件440和外部框架组件410之间的空隙或间隙(即，囊袋485)。这些血液建立暂时的流体密封，其聚集在该空间中并且针对伴随与心脏收缩和心脏舒张相关的心房内压力和心室内压力的泄漏诱导力提供压力缓冲。
图6是预配置可压缩的经导管假体心血管瓣膜400的实施例的分解图，所述瓣膜包含自膨胀内部框架450作为子部件。瓣膜400还包括外部框架组件410作为子部件。外部框架组件410和内部瓣膜组件440共同限定血栓形成囊袋485(未示出)。囊袋485形成于作为V形或U形囊袋的内部的内部瓣膜组件440以及作为V形或U形囊袋的外部的具有外部覆盖物430的外部框架组件410之间。在该瓣膜400中，内部瓣膜组件440具有心房血栓形成密封囊袋封闭件480(未示出)(例如，由线的圆形件或Halo电极形成)，具有可渗透网状织物或组织，其被缝合并且由此连接到内部框架450和/或瓣叶470。内部框架450包括由镍钛诺线制造的内部线框结构，其支撑被缝合到内部框架450的瓣叶570并且用作瓣膜。内部框架450包括在其开口端处联结以形成接合部402的三个主要U形线部件407。可选地，在一些实施例中，内部框架450能够包括附加的线交叉构件或撑杆(例如，三个以上)。
在该瓣膜400中，内部框架450与组织缝合并且用作盖以防止瓣膜泄漏。内部瓣膜组件440包括瓣叶470。瓣叶470包括限定瓣膜功能的铰接瓣叶。瓣叶470被缝合到内部框架450。内部框架450也具有用于附连拴系组件490的(拴系)附连孔411。拴系组件490在该例子中被示出为连接到心外膜固定垫454。在操作中，(通过瓣叶470)被覆盖的内部瓣膜组件440布置并且固定在外部框架组件410中。外部框架组件410也可以在各种实施例中具有外部覆盖物460。外部框架组件410包括具有套环盖448的铰接套环446。铰接套环446也可以在优选实施例中具有在A2区域处的平展或D形的部段462以适应和解决左心室流出道(LVOT)阻塞问题。套环446也可以具有专门形成的连合段以防止在A1-P1段451和A3-P3段453处的连合泄漏。
在操作中，可以使用导管输送技术将瓣膜400部署为假体瓣膜。瓣膜400在窄导管内被压缩并且与预先附连的拴系组件490一起输送到自体瓣膜的环形区域(例如，左心房)。在此，瓣膜400被推出导管，由此弹开成其预成形的功能形状而不需要手动膨胀(例如，使用内部球囊导管的手动膨胀)。当瓣膜400被牵拉就位时，外部框架组件410座置在自体瓣环(例如，自体二尖瓣环)中，让铰接套环446接合心房底部并且防止穿出(其中瓣膜被牵拉到心室中)。在这样的实施例中，不必像在现有的假体尝试中教导的那样切除自体瓣叶。而是，自体瓣叶能够用于提供围绕瓣膜400(例如，围绕外部框架组件410)的张紧和/或密封功能。有利的是非对称地部署瓣膜400以便解决LVOT问题，其中非适应性的假体瓣膜压靠瓣膜(例如，二尖瓣)的A2前段并且关闭通过主动脉的血流，主动脉在解剖学上位于瓣环(例如，二尖瓣环)的A2段的紧后方。
因此，D形部段462部署成大致紧邻/接触A2段，原因是平展的D形部段462在结构上较小并且具有更竖直的轮廓(更接近平行于外部框架组件410的纵向轴线)，由此提供作用于A2段的更小压力。一旦瓣膜400正确地座置，拴系组件490可以通过左心室的心尖区域伸出并且利用心外膜垫454或类似的缝合锁定附连机构进行固定。
图7-9分别是根据实施例的假体心脏瓣膜500的前视图、仰视图和俯视图。
假体心脏瓣膜500设计成用以替换损坏或病变的自体心脏瓣膜例如二尖瓣。瓣膜500包括外部框架组件510和联接到外部框架组件510的内部瓣膜组件540。
如图所示，外部框架组件510包括外部框架520，所述外部框架在其外表面的全部或一部分上由外部覆盖物530覆盖，并且在其内表面的全部或一部分上由内部覆盖物532覆盖。
外部框架520能够为假体心脏瓣膜500提供若干功能，包括用作主要结构、用作锚固机构和/或用于将瓣膜锚固到自体心脏瓣膜装置的独立锚固机构的附连点、承载内部瓣膜组件540的支撑件、和/或抑制假体心脏瓣膜500和自体心脏瓣膜装置之间的瓣周漏的密封件。
外部框架520配置成被操纵和/或变形(压缩和/或膨胀)，并且当释放时，返回到其初始(未变形)的形状。为了实现这一点，外部框架520能够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
Figure BDA0001635250730000111
是尤其有用的，原因是它能够被处理成奥氏体、马氏体或超弹性体。可以使用其它的形状记忆合金，如Cu-Zn-Al-Ni合金和Cu-Al-Ni合金。
如图7中清楚示出的那样，外部框架组件510具有上端(例如，在心房部分516处)、下端(例如，在心室部分512处)以及在其间的中间部分(例如，在瓣环部分514处)。外部框架组件510的中间部分具有配置成(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长。外部框架组件510的上端的周长大于中间部分的周长。在一些实施例中，外部框架组件510的上端的周长明显大于中间部分的周长。如图9中清楚示出的那样，外部框架组件510的上端和中间部分具有D形横截面。以这样的方式，外部框架组件510促进适当地配合到自体房室瓣膜的瓣环中。
内部瓣膜组件540包括内部框架550、外部覆盖物560和瓣叶570。如图所示，内部瓣膜组件540包括具有形成有多个弓形部的周边的上部分。内部框架550包括支撑外部覆盖物560和瓣叶570的六个轴向柱或框架构件。瓣叶570沿着图示为连合柱552(在图8中清楚地示出)的柱中的三个被附连，并且外部覆盖物560附连到另外三个柱554(在图8中清楚地示出)，并且可选地附连到连合柱552。外部覆盖物560和瓣叶570中的每一个由在它们的上端或心房端处联结在一起的大致矩形的片材形成。外部覆盖物560的下方的心室端可以联结到外部框架组件510的内部覆盖物532，并且瓣叶570的下方的心室端可以形成自由边缘575，但还是联接到连合柱552的下端。
尽管内部瓣膜组件540显示为具有三个瓣叶，但是在其它实施例中，内部瓣膜组件可以包括任意合适数量的瓣叶。瓣叶570能在打开配置和闭合配置之间移动，在所述闭合配置中瓣叶570以密封抵接的方式合紧或会合。
在下端或心室端，瓣叶570可以具有比外部覆盖物560更小的周长。因此，在连合柱552之间的瓣叶的自由下缘(相邻的连合柱之间的瓣叶570的每个部分被称为瓣叶570的“腹部”)与内部瓣膜组件540的外部覆盖物560的下缘径向地间隔开。这种径向间隔便于瓣叶570从打开位置移动到闭合位置，原因是在心脏收缩期间从心室到心房的血液的逆流能够捕捉到腹部的自由边缘并且推动瓣叶570闭合(例如，合紧)。
外部框架组件510的外部覆盖物530和外部框架组件510的内部覆盖物532、内部瓣膜组件540的外部覆盖物560和内部瓣膜组件540的瓣叶570可以如上所述地由任意合适的材料或材料的组合形成。在该实施例中，外部框架组件510的内部覆盖物532、内部瓣膜组件540的外部覆盖物560和内部瓣膜组件540的瓣叶570至少部分地由猪心包形成。而且，在该实施例中，外部框架组件510的外部覆盖物530至少部分地由聚酯形成。
在另一实施例中，瓣叶570能够可选地具有已用抗凝剂(例如但不限于固定肝素)进行处理(或与之反应)的表面。这样的当前可用的肝素化聚合物是已知的并且是本领域普通技术人员可获得的。
内部瓣膜组件540为大致圆柱形，并且外部框架组件510是渐缩的，从下方的心室部分512(在此它联接到内部瓣膜组件540)处的较小直径(略大于内部瓣膜组件540的外径)延伸到较大直径的心房部分516，并且中间直径的瓣环部分514介于心房部分和心室部分之间。
如图所示，渐缩的环形空间或囊袋585因此形成于内部瓣膜组件540的外表面和外部框架组件510的内表面之间，开向瓣膜组件500的心房端。如图所示，囊袋封闭件580沿着内部瓣膜组件540的上端的周边被联接。在一些实施例中，囊袋封闭件580或其一部分能够沿着内部瓣膜组件540的任意合适部分被联接。
如上所述，囊袋封闭件580能够至少部分地由任意合适的材料形成，所述材料的孔隙率足以允许血液(特别地包括红血细胞)进入囊袋585，但是其孔隙率不足以允许大血栓不合需要地离开囊袋585，或者不足以允许冲刷形成于囊袋585中的血栓。在该实施例中，囊袋封闭件580完全由具有约90-120微米的孔的针织聚酯(即，PET经编针织物)形成。在一些实施例中，囊袋封闭件可以包括小于约160微米的孔。
在图10-12中更详细地显示内部框架550。具体地，图10-12根据实施例分别示出处于未变形的初始状态的内部框架550(图10)、处于部署配置的内部框架550的侧视图(图11)、以及处于部署配置的内部框架550的仰视图(图12)。
在该实施例中，内部框架550由
Figure BDA0001635250730000141
的激光切割管形成。内部框架550在图10中示出为处于未变形的初始状态，即，示出为激光切割件，但是切开并且展开成平坦的片材以便于图示。内部框架550能够被分成四个部分，其对应于最终形式的内部框架550的功能不同的部分：心房部分541、主体部分542、撑杆部分543、以及拴系夹紧部分544。撑杆部分543包括将主体部分542连接到拴系夹紧部分544的六个撑杆，如撑杆543A。
连接部分544包括由成对的对置的、略呈V形的连接构件(或“微V形件”)周向地连接的撑杆的纵向延伸部。连接部分544配置成通过施加压缩力径向地塌缩，这导致微V形件变为更深的V形，顶点纵向地更靠拢在一起并且V形的开口端周向地更靠拢在一起。因此，连接部分544能够配置成压缩地夹紧或夹持拴系件的一端，直接连接到拴系线(例如，编织细丝线)或中间结构(例如依次牢固地固定到拴系线的聚合物或金属件)上。
相比于连接部分544，心房部分541和主体部分542配置成径向地膨胀。撑杆部分543形成膨胀的主体部分和压缩的连接部分544之间的纵向连接和径向过渡。
主体部分542包括六个纵向柱，如柱542A。柱能够用于将瓣叶570附连到内部框架540，和/或能够用于例如通过将内部框架540连接到外部框架520而将内部组件540附连到外部组件510。在所示的实施例中，柱包括开口，连接构件(如缝合细丝和/或线)能够穿过所述开口以将柱联接到其它结构。
内部框架550在图11和12的侧视图和仰视图中相应地显示为完全变形，即，变形到最终的部署配置。
在图13-15中更详细地显示瓣膜500的外部框架520。在该实施例中，外部框架520由
Figure BDA0001635250730000151
的激光切割管形成。外部框架520在图13中示出为处于未变形的初始状态，即，示出为激光切割件，但是切开并且展开成平坦的片材以易于图示。外部框架520能够被分成联接部分571、主体部分572、和端口部分573，如图13中所示。
联接部分571包括多个开口或孔如571A，外部框架520能够通过所述开口或孔联接到内部框架550，如下文更详细地所述。
外部框架520在图14和15的相应侧视图和俯视图中显示为完全变形，即，变形到最终的部署配置。在图15中清楚地看到，联接部分571的下端形成大体圆形的开口(在图15中由“O”标识)。该开口的直径优选地大致对应于内部框架550的主体部分542的直径，以便于联接瓣膜500的两个部件。
外部框架520和内部框架550在图16-18中相应地在前视图、侧视图和俯视图中显示为联接在一起。两个框架共同形成假体瓣膜(如瓣膜500)的结构支撑。框架与自体瓣环成期望关系地支撑瓣叶结构(例如，瓣叶570)，支撑两个框架的覆盖物(例如，外部覆盖物530、内部覆盖物532、外部覆盖物560)以针对心房和心室之间的血液泄漏提供屏障，并且(通过内部框架550)联接到拴系件(例如拴系组件590)以通过连接到心室壁的拴系连接帮助将假体瓣膜在自体瓣环中保持就位。外部框架520和内部框架550被连接在六个联接点(代表点被标识为“C”)处。在该实施例中，联接点用机械紧固件(如短长度的线)实现，所述机械紧固件穿过外部框架520的联接部分571中的孔(如孔571A)和内部框架550的主体部分542的纵向柱(如柱542A)中的相应开口。内部框架550因此布置在外部框架520内并且牢固地联接到外部框架520。
根据实施例，在图19中示出用于外部框架组件510的外部覆盖物530和/或外部框架组件的内部覆盖物532的切割、成形和尺寸确定的模板534(或设计型式)。设计型式534包括附连位置指示部536a、536b。为了将外部覆盖物530布置到组装配置中(即，联接到或准备联接到外部框架520)，外部覆盖物530的两端根据模板534的附连位置指示部536a、536b联接(例如，缝合)在一起。类似地，通过根据附连位置指示部536a、536b将端部联接(例如，缝合)在一起而将内部覆盖物532布置为组装配置。
图20根据实施例示出处于其初始的预组装状态(即，未附连到内部框架550)的内部瓣膜组件的一个瓣叶570和外部覆盖物560的关联部分的设计型式。如上所述，在相邻连合柱之间的瓣叶570的部分被称为瓣叶570的“腹部”。腹部具有在图20中用附图标记‘B’指示的弯曲边缘。在内部瓣膜组件540的组装期间，瓣叶570联接到内部瓣膜组件540的内部框架550。具体地，瓣叶570的腹部边缘B或其一部分在内部框架550的弓形部分处联接到内部框架550。另外，外部覆盖物560在内部框架550的一部分(例如，弓形部分)上沿着用‘F’指示的轴线折叠，并且沿着附连线A联接到内部框架550的一部分(例如，连合柱552)。如图所示，联接区域C(例如，缝合区域)布置在附连线A的外部并且邻近附连线A。联接区域C能够便于进行组装过程。随后，过量的瓣叶材料和/或过量的外部覆盖物材料能够被切除并且被处置或再使用。例如，布置在腹部边缘B和F轴线之间的材料或者在联接区域C中的材料在一些实施例中可能是非必要的材料并且因此能够从瓣叶570和/或外部覆盖物560切除。能够针对每个瓣叶570、每个外部覆盖物560和每个连合柱552来重复组装过程。
瓣叶570和外部覆盖物560可以具有任意合适的尺寸、形状、材料和/或配置。例如，在该实施例中，瓣叶570和/或外部覆盖物560由具有约0.01英寸厚度的固定猪心包形成。
在图21和22中显示假体心脏瓣膜的另一实施例的示意图。假体心脏瓣膜600设计成替换损坏或病变的自体心脏瓣膜，如二尖瓣。瓣膜600包括外部框架组件610和联接到外部框架组件610的内部瓣膜组件640。
尽管未在图21和22中的外部框架组件610的示意图中独立地示出，但是外部框架组件610可以由外部框架620形成，所述外部框架在其外表面的全部或一部分上由外部覆盖物630覆盖，并且在其内表面的全部或一部分上由内部覆盖物632覆盖。假体心脏瓣膜600的部件的材料和构造可以类似于上述的其它实施例。以下论述集中在该实施例的不同于先前实施例的方面。
内部瓣膜组件640包括内部框架650(未示出)、外部覆盖物660(未示出)、瓣叶670(未示出)、和心房结构655(例如，Halo电极)。如图所示，Halo电极655布置在内部瓣膜组件640的心房部分616处。在这样的配置中，当瓣膜600植入患者的心脏中时，Halo电极655将布置在患者心脏的心房底部和/或自体瓣环的上方。以该方式，Halo电极655提供内部框架650(例如，在自体二尖瓣环上方)的扩展功能。在一些情况下，例如，如果假体瓣叶相对于自体瓣环过低地座置，则瓣叶可能不适当地合紧(例如，不完全合紧)和/或可能会发生血液动力泄漏。因此，将Halo电极655布置在自体瓣环上方能够提供和/或促进完全合紧。
Halo电极655可以由任意合适的方法和材料形成。例如，在一些实施例中，Halo电极655能够由线的大致圆形件形成。在这样的实施例中，Halo电极655能够联接(例如，缝合)到内部框架650。
外部框架620的外部覆盖物630和内部覆盖物632、外部覆盖物660和瓣叶670可以由任意合适的材料或材料的组合形成，正如以上结合其它实施例所述的那些材料。
如图21和22所示，内部瓣膜组件640可以为大致圆柱形，并且外部框架组件610可以是渐缩的，从下方的心室部分612(在此它联接到内部瓣膜组件640)处的较小直径(略大于内部瓣膜组件640的外径)延伸到较大直径的心房部分616，并且中间直径的瓣环部分614介于心房部分和心室部分之间。
在一些实施例中，内部瓣膜组件610的外表面和/或外部框架组件640的内表面不需要如图21和22中示意性所示地在横截面上为圆形，而是可以在沿着瓣膜600的中心轴线的指定位置处具有非恒定半径。
心房Halo电极655通过在改进的假体心脏瓣膜中使内部瓣膜组件的内部框架在心房底部的平面上方延伸而起作用，所述假体心脏瓣膜包括保持瓣叶的内部框架，并且其布置在外部框架中以便当假体心脏瓣膜布置在心脏瓣膜(例如二尖瓣，三尖瓣)中时减小或防止泄漏。
将瓣叶设置在升高的瓣叶筒仓或圆筒(例如，Halo电极650)中的益处是改善血流和瓣叶封闭。已发现在瓣叶圆筒处于心房底部的情况下，瓣叶合紧是不完全的并且能够导致血液动力泄漏。
因此，通过提供升高到自体瓣环或心房底部的平面上方的心房Halo电极或环结构，促进了完全的瓣叶合紧。在心室收缩或心脏收缩期间，血液朝向主动脉瓣喷射以离开心脏，但是也朝向在心脏收缩期间需要保持闭合的假体二尖瓣喷射。撞击假体瓣叶的逆流血液导致瓣叶闭合，防止逆流到左心房中。在心脏舒张或心室填充期间，血液需要从心房流动到心室而不阻塞。然而，当假体瓣叶未正确地放置或正确地对准时，瓣叶可能会阻碍心室的有效填充或者导致不均匀的心室输出。
图23是作为图21和22示意性示出的假体心脏瓣膜的一种可行的实施方式的、根据实施例的假体心脏瓣膜700的俯视图。假体心脏瓣膜700包括外部框架组件710、内部瓣膜组件740和拴系组件790。内部瓣膜组件740包括内部框架750、外部覆盖物760(未示出)、瓣叶770、和心房结构755(例如，Halo电极)。Halo电极755可以由线的圆形件形成，其能够连接到内部框架750并且缝合到瓣叶770。内部框架750能由
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线制造，其支撑被缝合到内部框架750的瓣叶770并且用作瓣膜。图23所示的内部框架750包括联接在其开口端处以形成接合部702的三个U形的线部件。瓣叶770缝合到这些部件以形成铰接瓣叶，所述铰接瓣叶构建并且用作假体瓣膜(例如，假体二尖瓣，假体三尖瓣)。
在一些实施例中，内部框架750具有用于附连拴系组件790的拴系附连孔711(未示出)。拴系组件790连接到心外膜固定垫754(未示出)。
在操作中，内部框架750(具有瓣叶770)布置并且固定在外部框架组件710的外部框架720中。外部框架720包括外部覆盖物730(未示出)(例如，组织材料)和内部覆盖物732(例如，组织材料)。外部框架720包括具有套环盖748的铰接套环746。铰接套环746配置成(例如，成形为和尺寸确定成)用以解决由自体结构引起的泄漏问题。特别地，套环746包括A2段747、P2段749、以及两个连合段即A1-P1段751和A3-P3段753。套环746也可以在一些实施例中具有A2段的缩短或平展或D形的部段762，以便适应和解决左心室流出道(LVOT)阻塞问题。
在操作中，可以使用导管输送技术将瓣膜700部署为假体二尖瓣。整个瓣膜700在窄导管内压缩并且与预先附连的拴系装置一起输送到自体瓣膜的环形区域(优选地为左心房)。当输送时，瓣膜700被推出导管，由此弹开成其预成形的功能形状而不需要手动膨胀(例如，使用内部球囊导管的手动膨胀)。当瓣膜700被推动和/或牵拉就位时，外部框架组件710座置在自体瓣环(例如，自体二尖瓣环)中，让铰接套环746接合心房底部并且防止穿出(其中瓣膜被牵拉到心室中)。在这样的实施例中，不必像在现有的假体尝试中所教导的那样切除自体瓣叶。而是，自体瓣叶可以用于提供围绕外部框架组件710的张紧和/或密封功能。有利的是非对称地部署瓣膜700以便解决LVOT问题，其中非适应性的假体瓣膜压靠瓣膜(例如，二尖瓣)的A2前段并且关闭通过主动脉的血流，主动脉在解剖学上位于二尖瓣环的A2段的紧后方。因此，D形部段762部署成大致紧邻/接触A2段，原因是平展的D形部段762在结构上较小并且具有更竖直的轮廓(更接近平行于外部支架的纵向轴线)，由此提供作用于A2段的更小压力。一旦瓣膜700正确地座置，拴系组件790可以通过左心室的心尖区域伸出并且使用心外膜垫754或类似的缝合锁定附连机构(未示出)进行固定。
在可选实施例中，拴系组件790位于外部框架720上，其相应地具有用于将拴系组件790附连到心外膜固定垫754的拴系附连孔713。
图24是根据实施例的假体心脏瓣膜700的A1-P1侧的透视图。图24示出了在其开口端处联结以形成接合部702的内部框架750的三个U形线部件中的一个。尽管示出了三个U形线部件，但是在其它实施例中，任意合适数量的U形线部件能够在其开口端处联结以形成接合部。类似地，在一些实施例中，内部框架750的线部件能够具有任意合适的形状或尺寸。瓣叶770缝合到这些部件以形成铰接瓣叶770，所述铰接瓣叶770构建并且用作假体心脏瓣膜(例如，二尖瓣，三尖瓣)。心房Halo电极755显示为在套环的主要部分的平面上方的圆形线的平面，所述主要部分不包括竖直A2段747、P2段749以及连合的A1-P1段751和A3-P3段753。图24示出了当部署时血液将如何填充瓣膜700的A1-P1段751处的内部框架750和外部框架720之间的空隙或间隙707。这些血液形成暂时的流体密封，其聚集在该空间中并且针对伴随与心脏收缩和心脏舒张相关的心房内压力和心室内压力的泄漏诱导力提供压力缓冲。
图25是根据实施例的假体心脏瓣膜700的A3-P3侧753的透视图。图25示出了在其开口端处联结以形成接合部702的内部框架750的三个U形线部件中的一个。瓣叶770缝合到这些部件以形成铰接瓣叶770，所述铰接瓣叶770构建并且用作假体心脏瓣膜。心房Halo电极755显示为在套环的主要部分的平面上方的圆形线的平面，所述主要部分不包括竖直A2段747、P2段749以及连合的A1-P1段751和A3-P3段753。图25示出了当部署时血液将如何填充瓣膜700的A3-P3段753处的内部框架750和外部框架720之间的空隙或间隙708。这些血液形成暂时的流体密封，其聚集在该空间中并且针对伴随与心脏收缩和心脏舒张相关的心房内压力和心室内压力的泄漏诱导力提供压力缓冲。
图26是根据实施例的假体心脏瓣膜700的分解图。在该瓣膜700中，内部框架750与组织706缝合在一起并且用作盖以防止瓣膜泄漏。内部框架750包含瓣叶770，所述瓣叶包括限定瓣膜功能的铰接瓣叶。瓣叶770缝合到内部框架750。内部框架750也具有用于附连拴系组件790的拴系附连孔711。拴系组件790在该例子中显示为连接到心外膜固定垫754。在操作中，被覆盖的内部框架750(例如，覆盖有外部覆盖物760)(覆盖有瓣叶770)布置并且固定在外部框架组件710的外部框架720内。外部框架720也可以在各种实施例中具有覆盖物(例如，外部覆盖物730)。外部框架720包括具有套环盖748的铰接套环746。铰接套环746也可以在一些实施例中具有D形部段762以适应和解决左心室流出道(LVOT)阻塞问题。
在操作中，可以使用导管输送技术将瓣膜700作为假体瓣膜(例如，二尖瓣)进行部署。整个瓣膜700在窄导管内压缩并且例如与预先附连的拴系组件790一起输送到自体瓣膜的环形区域。在此，瓣膜700被推出导管，由此弹开成其预成形的功能形状而不需要手动膨胀(例如，使用内部球囊导管的手动膨胀)。当瓣膜700被推动和/或牵拉就位时，外部框架组件710座置在自体二尖瓣环中，让铰接套环746接合心房底部并且防止穿出(其中瓣膜被牵拉到心室中)。在这样的实施例中，不必像在现有的假体尝试中所教导的那样切除自体瓣叶。而是，自体瓣叶可以用于提供围绕外部框架组件710的张紧和/或密封功能。有利的是非对称地部署瓣膜700以便解决LVOT问题，其中非适应性的假体瓣膜推压瓣膜(例如，二尖瓣)的A2前段并且关闭通过主动脉的血流，主动脉在解剖学上位于二尖瓣环的A2段的紧后方。因此，D形部段762部署成大致紧邻/接触A2段，原因是平展的D形部段762在结构上较小并且具有更竖直的轮廓(更接近平行于外部支架的纵向轴线)，由此提供作用于A2段的更小压力。一旦瓣膜700正确地座置，拴系组件790可以通过左心室的心尖区域伸出并且使用心外膜垫754或类似的缝合锁定附连机构进行固定。
上述假体心脏瓣膜实施例中的任何一个可以包含附加结构特征以增强其性能。下面参考在图27和28的相应透视图和侧视图中示意性示出的假体心脏瓣膜800来论述这些结构特征。
如图所示，外部框架820具有心房部分826、心室部分822以及布置在心房部分826和心室部分822之间的瓣环部分824。内部瓣膜组件840的内部框架850具有第一端和第二端。内部瓣膜组件840可以通过内部框架850的第一端和外部框架组件810的心室部分812之间的连接部联接到外部框架820。内部框架组件840可以从该连接部朝向外部框架组件810的心房部分816延伸。内部框架组件840和外部框架组件810可以从该连接部朝向外部框架组件810的心房部分816渐扩。外部框架组件810的瓣环部分814可以与内部框架组件840径向地间隔开并且能够朝向内部瓣膜组件840径向向内地偏转以将自体心脏瓣环容纳在瓣环部分814中。
外部框架组件810可以以任意合适的方式成形和确定尺寸以便于准确地配合到自体心脏瓣膜中。例如，如图所示，外部框架820可以成形和尺寸确定成至少部分地类似于沙漏形状。具体地，外部框架组件810的瓣环部分814从靠近心室部分812的中间直径(或周长)变化到靠近瓣环部分814的中部的较小直径(或周长)、以及变化到靠近心房部分816的较大直径(或周长)。因此，瓣环部分814具有沙漏形状。心室部分812的最大直径大于瓣环部分816的最大直径。心室部分的最小直径小于瓣环部分814的最小直径。
外部框架820的每个部分的直径和/或周长可以基于要在其中植入假体心脏瓣膜800的自体心脏瓣膜的尺寸和/或形状进行选择。例如，外部框架820的瓣环部分824的最小直径可以小于自体心脏瓣环的最小直径。因此，在这样的配置中，心室部分822、瓣环部分824和心房部分826的直径能够共同促成假体心脏瓣膜800合适地配合(例如，贴合、牢固配合)到自体心脏瓣膜中。以该方式，外部框架820能够配置成用以优化假体心脏瓣膜800(特别是外部框架组件810)和自体心脏瓣膜的自体瓣环之间的固定和密封。因此，这样的配置使得瓣周漏的可能性最小化。
尽管外部框架820显示为具有圆形横截面，但是在一些实施例中，外部框架820可以具有任意合适的形状或尺寸。例如，在一些实施例中，外部框架820可以具有D形横截面。以该方式，外部框架820可以具有配置成对应于(例如，配合)自体心脏瓣环的形状。
作为上述的具有沙漏形状的外部框架820和/或外部框架组件810的附加或替代，瓣膜800或者在一些情况下特别是外部框架820和/或外部框架组件810可以形成为提供在空间上(即，轴向地和/或周向地)变化的刚度例如抗环箍压缩性。
以该方式，合适的刚度分布可以布置成使得当布置在自体心脏瓣膜中时瓣膜800能够促成期望的形状和密封区域，因此最小化瓣周漏和瓣膜的不合需要的运动的可能性。也就是说，瓣膜800可以配置成具有适合于导致自体心脏瓣环(即，密封区域)的期望变形和因此适合于导致瓣膜800的正确植入的刚度分布。
可以通过改变外部框架组件810和内部瓣膜组件840的性质、特性和/或布置而实现假体瓣膜800的期望刚度分布。例如，外部框架820和/或内部框架850可以包含材料状态有所变化的部分。例如，外部框架820的第一部分可以处于弹性状态，而外部框架820的第二部分处于超弹性状态。类似地，例如，外部框架820和/或内部框架850的某些部分可以处于奥氏体状态和/或马氏体状态(例如，应力诱导的马氏体状态)。以该方式，瓣膜800的某些部分可以配置成与自体瓣环合适地配合，因此改善密封并且限制瓣周漏。
另外，外部框架组件810和/或内部瓣膜组件840可以具有变化的宽度、厚度、形状(例如，纵向形状)、角度(例如，内部瓣膜组件840和外部框架组件810之间的附连角度)等。在一些实施例中，外部覆盖物830、内部覆盖物832、外部覆盖物860和/或囊袋封闭件880可以配置成至少部分地确定瓣膜800的刚度分布和/或形状(例如，基于缝合型式)。
图29B以及29C和29D分别示出了根据实施例的假体心脏瓣膜800(如图29A所示)的轴向和周向的刚度分布。心脏瓣膜800的刚度能够以任意合适的方式轴向地和/或周向地变化。例如，图29B表示瓣膜800的轴向刚度分布。具体地，如图所示，Z轴表示瓣膜800上的轴向位置(例如，刚度值的位置)。S轴表示刚度的范围(或刚度值的范围)，该范围从左(开始于原点O)向右增加。
进一步参考该例子，如图29B所示，在一些实施例中，靠近外部框架822的心室部分822的位置(例如，在图29A中指示为B)能够具有更大的刚度值，靠近外部框架820的瓣环部分824的位置相对于心室部分822能够具有更小的刚度值(例如，便于与自体瓣环协作)，并且靠近外部框架820的心房部分826的位置(例如，在图29A中指示为A)与靠近瓣环部分824的刚度值相比能够具有更小、相同或更大的刚度值(由虚线示出)。以该方式，外部框架组件810可以在中心的瓣环部分814中比在心室部分812处在环箍压缩方面相对更顺应。因此，在使用中，假体瓣膜800能够牢固地座置在自体心脏瓣膜的瓣环中，同时对内部瓣膜组件840施加的能够使瓣叶870的性能降低的负荷最小。尽管为了易于示出，图29B中所示的刚度分布包括线性部分，但是在一些实施例中，刚度分布可以包括作为如图所示的线性部分的替代或附加的非线性部分。
类似地，心脏瓣膜800或心脏瓣膜800的某些部分的刚度能够具有周向地变化的刚度，如图29C和29D示出的刚度分布所示。作为例子，图29C示出轴向位置A(如图29A中的附图标记‘A’所示)处的周向刚度分布。类似地，图29D示出轴向位置B(如图29A中的附图标记‘B’所示)处的周向刚度分布。当分布从原点(标注为‘O’)径向地延伸时，刚度值增加。
因此，如图29C所示，S1(90度)处的刚度大于S2(270度)处的刚度。进一步参考该例子，在一些实施例中，从零到180度的圆周部分能够表示具有D形配置的外部框架组件810的外部框架820的相对平坦部分，并且180度到360度能够表示具有D形配置的外部框架820的相对弯曲部分。
以类似方式，图29D示出轴向位置B(如图29A中的附图标记‘B’所示)处的周向刚度分布。如图所示，轴向位置B具有不同于轴向位置A的刚度分布。如上所述，设计中的这样的变化能够提供心脏瓣膜800的有利定制，以及心脏瓣膜800与自体心脏瓣膜的协作。类似于图29C，图29D示出在瓣膜800的一侧的刚度大于在瓣膜800的另一侧的刚度。以该方式，在一些情况下，与将受到更小或更少的力的瓣膜800的部分相比，将受到来自自体心脏瓣环的更大的力的瓣膜800的部分能够具有更小的刚度值(例如，更顺应)，因此优化假体心脏瓣膜800与自体心脏(特别是自体心脏瓣环区域)的协作。
尽管上面已描述了各种实施例，但是应当理解它们仅仅作为例子给出而不是限制性的，因此，可以在型式和/或细节上进行各种变化。本文所述的装置和/或方法的任何部分能够以任意合适的组合方式进行组合，除非另有明确说明。在上述的方法和/或图解指示某些事件按照某种顺序进行的情况下，某些事件的排序和/或流程型式可以被修改。另外，在可行的情况，某些事件可以下在并行过程中同时执行、以及顺序地执行。

Claims (8)

1.一种假体心脏瓣膜，其包括：
外部框架组件，所述外部框架组件具有心房部分、心室部分、以及在所述心房部分和所述心室部分之间的瓣环部分；
内部瓣膜组件，所述内部瓣膜组件包括内部框架，所述内部框架具有心房端和心室端，
所述内部瓣膜组件通过所述内部框架的心室端和所述外部框架组件的心室部分之间的连接部而联接到所述外部框架组件，
从所述连接部朝向所述外部框架组件的心房部分延伸的内部框架组件，
所述内部框架组件和所述外部框架组件从所述连接部朝向所述外部框架组件的心房部分渐扩，
所述外部框架组件的瓣环部分和心房部分与所述内部瓣膜组件径向地间隔开并且能够朝向所述内部瓣膜组件径向向内地偏转，
所述假体心脏瓣膜包括从假体心脏瓣膜的第一侧到假体心脏瓣膜的相对的第二侧变化的周向刚度。
2.根据权利要求1所述的假体心脏瓣膜，其中，所述外部框架组件的心房部分和瓣环部分中的每一者都被成形为对应于自体房室瓣膜的瓣环并且具有相对弯曲部分和相对平坦部分，所述假体心脏瓣膜的周向刚度在所述相对弯曲部分和所述相对平坦部分之间变化。
3.根据权利要求1所述的假体心脏瓣膜，其中，所述外部框架组件的心房部分和瓣环部分中的每一者都被成形为对应于自体房室瓣膜的瓣环。
4.根据权利要求1所述的假体心脏瓣膜，其还包括：
被支撑在所述内部框架上的瓣叶组件。
5.根据权利要求1所述的假体心脏瓣膜，其中：
所述内部瓣膜组件包括覆盖物，所述覆盖物围绕所述内部框架的周边布置并且由基本上不透血液的材料形成，并且
所述外部框架组件包括外部框架和内部覆盖物，所述内部覆盖物围绕所述外部框架的内周边布置并且由基本上不透血液的材料形成，所述内部框架的覆盖物联接到所述外部框架的内部覆盖物。
6.根据权利要求1所述的假体心脏瓣膜，其中：
所述瓣环部分具有沙漏形状，所述沙漏形状的最小周长布置在靠近所述心房部分的较大周长和靠近所述心室部分的较大周长之间，所述外部框架组件的心室部分的最大周长大于所述外部框架组件的瓣环部分的最大周长，并且所述心室部分的最小周长小于所述瓣环部分的最小周长。
7.根据权利要求1所述的假体心脏瓣膜，其中，所述外部框架组件具有沙漏形状。
8.根据权利要求1所述的假体心脏瓣膜，其中：
所述外部框架组件的心室部分的最大周长大于所述瓣环部分的最大周长，并且
所述外部框架组件的心室部分的最小周长小于所述瓣环部分的最小周长。
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