CN109589188A - 带有保持元件的假体心脏瓣膜 - Google Patents

带有保持元件的假体心脏瓣膜 Download PDF

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CN109589188A
CN109589188A CN201910059247.3A CN201910059247A CN109589188A CN 109589188 A CN109589188 A CN 109589188A CN 201910059247 A CN201910059247 A CN 201910059247A CN 109589188 A CN109589188 A CN 109589188A
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CN109589188B (zh
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N·L·贝内特
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Edwards Lifesciences Corp
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    • 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
    • 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
    • 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
    • A61F2/2415—Manufacturing methods
    • 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
    • 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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  • Oral & Maxillofacial Surgery (AREA)
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Abstract

所描述的实施例涉及具有瓣叶框架(200)和瓣叶构造(300)的中心开口的瓣叶假体瓣膜装置。瓣叶构造至少部分地联接到瓣叶框架的瓣叶框架外侧并且由保持元件(400)联接到瓣叶框架外侧。

Description

带有保持元件的假体心脏瓣膜
本申请是国际申请号为PCT/US2015/050113，国际申请日为2015年09月15日，进入中国国家阶段的申请号为201580049409.5，名称为“带有保持元件的假体心脏瓣膜”的发明专利申请的分案申请。
技术领域
本公开大体上涉及假体瓣膜，并且更具体地涉及柔性瓣叶式假体心脏瓣膜装置。
背景技术
多种制造技术已用来将瓣叶联接到框架，包括将各个瓣叶缝合到框架(生物的和合成的)，并且仅对于合成瓣叶来说，将聚合物注塑成型和浸涂到框架上。在许多情况下，所得到的瓣叶支撑在框架上，并且限定活瓣，该活瓣具有安装边缘和允许活瓣移动的自由边缘，在安装边缘处，瓣叶联接到框架。活瓣在流体压力的影响下移动。在操作中，瓣叶在上游流体压力超过下游流体压力时打开，并且在下游流体压力超过上游流体压力时闭合。瓣叶的自由边缘在闭合瓣膜的下游流体压力的影响下对合，以防止下游血液逆行流过瓣膜。
在瓣叶打开和闭合的重复荷载下的瓣膜耐久性部分地取决于在瓣叶和框架之间的荷载分布。此外，当处于闭合位置时，在瓣叶上遇到显著的荷载。瓣叶的机械失效可发生在例如安装边缘处，在那里，柔性瓣叶由相对刚性的框架支撑，特别是在连合柱处。瓣叶打开和闭合的重复荷载通过部分地取决于瓣叶材料的疲劳、蠕变或其它机制导致材料失效。在安装边缘处的机械失效对于合成瓣叶来说尤其普遍。
仍然需要一种更耐久的柔性瓣叶假体瓣膜。
发明内容
所描述的实施例涉及用于诸如心脏瓣膜置换的瓣膜置换的设备、系统和方法。更具体地，所描述的实施例涉及具有生物或合成瓣叶材料和框架的柔性瓣叶瓣膜装置，以及制造和植入瓣膜装置的方法。
根据一个实施例，假体心脏瓣膜包括瓣叶框架组件。瓣叶框架组件是瓣叶框架、瓣叶构造和保持元件的组件。瓣叶构造是包括瓣叶和用于将瓣叶联接到瓣叶框架的结构的那部分瓣膜。根据一个实施例，瓣叶构造限定毗连的环形圈，其限定多个瓣叶和在瓣叶中的每一个之间的桥区域。每个桥区域限定邻近第一瓣叶的桥第一端部和邻近第二瓣叶的桥第二端部。当联接到瓣叶框架时，瓣叶从瓣叶框架径向向内延伸。瓣叶中的每一个限定折叠部分，该折叠部分折叠到并且抵靠于瓣叶框架的瓣叶框架外侧上，且例如利用固定结构联接到瓣叶框架外侧，该固定结构为例如但不限于缝合线、粘合剂、热结合或其它手段。桥区域中的每一个限定桥环，且在桥环和相邻的瓣叶之间具有对合颈部。对合颈部能操作成穿过柱狭槽中的一个，以使得桥环邻近瓣叶框架的外部部分，并且瓣叶从瓣叶框架径向向内延伸。保持元件设置在桥环内，从而有效地防止桥环穿过柱狭槽。保持元件可以例如利用固定结构联接到连合柱，固定结构为例如但不限于缝合线、粘合剂、热结合或其它手段。瓣叶中的每一个的折叠部分围绕瓣叶框架的流入边缘折叠，且例如利用固定结构联接到流入边缘，固定结构为例如但不限于缝合线、粘合剂、热结合或其它手段。
根据一个实施例，一种制造假体瓣膜的方法包括获得管，该管包括膨胀型PTFE复合物的一个或多个层。切割瓣叶构造，该瓣叶构造包括多个瓣叶，每个瓣叶通过桥区域与管分离。提供在瓣叶的折叠部分中的折叠小孔和在桥区域中的桥小孔。获得多个保持元件，每个保持元件限定保持元件小孔。将桥区域中的每一个折叠成桥环并在每个桥环和两个相邻瓣叶之间限定对合颈部，桥环远离管轴线径向延伸。将保持元件设置到桥环中的每一个内。将每个保持元件缝合到相应的桥环，使缝合线穿过桥小孔和与桥小孔对准的保持元件小孔。从金属管切割瓣叶框架，该金属管限定瓣叶框架窗口和在瓣叶框架窗口之间的连合柱，其中每个连合柱限定柱狭槽，该柱狭槽的尺寸设计成接纳桥区域的两倍厚度。在瓣叶窗口框架中提供瓣叶窗口框架小孔，并在连合柱中提供柱小孔。利用邻近柱外侧的保持元件将每个对合颈部设置在相应的柱狭槽中，并且将瓣叶设置在瓣叶框架中。将保持元件小孔与柱小孔对准。将每个保持元件缝合到相应的连合柱，使缝合线穿过保持元件小孔和与保持元件小孔对准的柱小孔。将每个瓣叶的折叠部分沿着瓣叶框架流入边缘且抵靠瓣叶框架外侧折叠，将折叠小孔与瓣叶窗口框架小孔对准。并且将每个折叠部分缝合到相应的瓣叶窗口框架，使缝合线穿过折叠小孔和与折叠小孔对准的瓣叶窗口框架小孔。
附图说明
附图被包括以提供对本公开的进一步理解且被并入而构成本说明书的一部分，其示出了本文所述实施例，并且与说明书一起用于解释本公开中讨论的原理。
图1A是根据一个实施例的假体心脏瓣膜的流出侧立体图；
图1B是图1A的瓣膜的实施例的流入侧立体图；
图2是图1A的瓣膜的实施例的瓣叶框架组件的立体图；
图3是瓣膜的实施例的瓣叶框架、保持元件、瓣叶构造和基部框架的侧分解图；
图4是根据一个实施例的展开到平坦取向的图3的瓣膜的实施例的表示；
图5A是根据图2的实施例的成形为桥环的桥区域的立体图；
图5B是根据图2的实施例的成形为桥环且包含保持元件的桥区域的立体图；
图6是图7的实施例的桥区域的侧视图；
图7是根据图1A的瓣膜的实施例的瓣叶框架组件和基部框架的立体图；以及
图8是根据另一个实施例的桥区域的侧视图，示出了成角度α的折叠线。
具体实施方式
本领域的技术人员将容易理解，本公开的各个方面可由构造成执行预期功能的许多方法和设备来实现。换句话说，其它方法和设备可以并入本文中以执行预期功能。还应该指出的是，本文所引用的附图未必按比例绘制，而是可能被夸大，以示出本公开的各个方面，并且就这一点而言，附图不应理解为限制性的。
虽然本文的实施例可以结合各种原理和观点描述，但所描述的实施例不应受理论约束。例如，实施例在本文中结合假体瓣膜(更具体地心脏假体瓣膜)来描述。然而，本公开范围内的实施例可以应用于具有类似的结构和/或功能的任何瓣膜或机构。而且，本公开范围内的实施例可以应用于非心脏应用中。
本文中在假体瓣膜的上下文中使用的术语“瓣叶”是单向瓣膜的柔性部件，其中，瓣叶能操作成在压差的影响下在打开位置和闭合位置之间移动。在打开位置，瓣叶允许血液流过瓣膜。在闭合位置，瓣叶基本上阻止通过瓣膜的逆流。在包括多个瓣叶的实施例中，每个瓣叶与至少一个相邻的瓣叶配合来阻止血液的逆流。血液中的压差例如由心脏的心室或心房的收缩引起，这样的压差通常由在闭合时瓣叶一侧上积聚的流体压力导致。随着瓣膜的流入侧上的压力升高至高出瓣膜的流出侧上的压力，瓣叶打开，并且血液流过其中。随着血液流过瓣膜进入相邻的心腔或血管中，流入侧上的压力与流出侧上的压力平衡。随着瓣膜的流出侧上的压力升高至高出瓣膜的流入侧上的血压，瓣叶返回至闭合位置，从而大体上防止血液通过瓣膜的逆流。
本文所用术语“膜”是指片材，其包括单种材料，例如但不限于膨胀型含氟聚合物。
本文所用术语“复合材料”是指膜(例如但不限于膨胀型含氟聚合物)和弹性体(例如但不限于含氟弹性体)的组合。弹性体可以包含在膜的多孔结构内，涂布在膜的一侧或两侧上，或者涂布在膜上和包含在膜内的组合。
本文所用术语“层合物”是指多层膜、复合材料、或诸如弹性体的其它材料、以及它们的组合。
本文所用术语“薄膜”通常是指膜、复合材料或层合物中的一者或多者。
如本文所用，术语“生物相容性材料”通常是指具有生物相容性特性的任何材料，包括：合成材料，例如但不限于生物相容性聚合物；或生物材料，例如但不限于牛心包膜。
本文所用术语“天然瓣膜孔口”和“组织孔口”是指可在其中放置有假体瓣膜的解剖结构。这样的解剖结构包括但不限于其中心脏瓣膜可能或可能没有以外科方式移除的位置。应当理解，可接纳假体瓣膜的其它解剖结构包括但不限于静脉、动脉、管和分流管。还应当理解，瓣膜孔口或植入部位也可以指在合成或生物导管中可以接纳瓣膜的位置。
如本文所用，“联接”表示接合、连接、附连、粘附、固定或结合，不论直接地或间接地，并且也不论永久性地或临时地。
本文的实施例包括用于假体瓣膜的各种设备、系统和方法，例如但不限于心脏瓣膜置换。瓣膜可作为单向瓣膜操作，其中，瓣膜限定瓣膜小孔，瓣叶通向该小孔，以响应于流体压差允许流动和闭合，以便封堵瓣膜小孔并防止流动。
图1A和图1B分别是根据一个实施例的呈假体心脏瓣膜形式的瓣膜100的流出立体图和流入立体图。图1A和图1B中可见的瓣膜100的部件包括三个柔性瓣叶310、包括已覆盖有各种材料的三个连合柱210的瓣叶框架200、已覆盖有各种材料的基部框架500、和缝合封套600。瓣叶310的瓣叶自由边缘312以Y形图案(当从上方观察时)在对合区域316处并到一起(聚在一起)，以闭合瓣膜100。当流出侧(如在图1A中观察到的)上的血液的压力大于瓣膜的流入侧(如在图1B中观察到的)上的血液的压力时，瓣膜100以这种方式闭合。当瓣膜100的流入侧上的血液的压力大于瓣膜100的流出侧上的血液的压力时，瓣叶310的瓣叶自由边缘312移开，以打开瓣膜100，并且让血液从流入侧流过瓣膜100，如在图1B中观察到的。
图2-5B示出了根据一个实施例的包括在瓣膜100中的各种部件。
图2是根据一个实施例的瓣叶框架组件234的立体图，并且在图3中以分解图和图4中以分解图示出了瓣叶框架组件234，其中，环形部件已被纵向切割并展开，以便更好地示出瓣膜部件的元件。瓣叶框架组件234包括瓣叶框架200、瓣叶构造300和多个保持元件400。
瓣叶框架
瓣叶框架200能操作成保持和支撑瓣叶构造300。瓣叶框架200为环形的，即，其限定具有轴线X的圆柱体和彼此间隔开的多个连合柱210，多个连合柱210平行于轴线X延伸，每个连合柱210限定穿过其中的柱狭槽217，柱狭槽217平行于轴线X对准。在连合柱210之间为瓣叶窗口222，瓣叶窗口222能操作成除了瓣叶自由边缘312之外围绕瓣叶310的周界联接到并且支撑瓣叶310。
瓣叶框架200限定圆柱体，该圆柱体具有瓣叶框架内侧202和与瓣叶框架内侧202相对的瓣叶框架外侧204。瓣叶框架200还限定多个连合柱210。每个连合柱210具有柱外侧212和与柱外侧212相对的柱内侧214。连合柱210由第一柱腿216和第二柱腿218限定，第一柱腿216和第二柱腿218由两者间的柱狭槽217分离。连合末端219联接第一柱腿216和第二柱腿218。
根据一个实施例，瓣叶框架200是围绕瓣膜100的中心纵向轴线X环形的，如图2和图3所示。瓣叶框架200限定遵循瓣叶310的形状的多个瓣叶窗口222。根据一个实施例，瓣叶窗口222中的每一个包括两个瓣叶窗口侧部(侧边)223和一个瓣叶窗口基部225，从而限定等腰梯形的三个边，其中，瓣叶窗口基部225为基本上平坦的。瓣叶基部325联接到瓣叶窗口基部225，并且两个瓣叶侧部323中的每一个联接到两个瓣叶窗口侧部223中的一个。相邻的瓣叶窗口侧部223由连合柱210互连，连合柱210由第一柱腿216和第二柱腿218构成，第一柱腿216和第二柱腿218从相邻的瓣叶窗口侧部223延伸并在连合末端219处相遇。连合柱210围绕瓣叶框架200彼此等间距地间隔开。第一柱腿216和第二柱腿218限定位于两者之间的柱狭槽217。
瓣叶框架200可被蚀刻、切割、激光切割、冲压、三维打印或用其它合适的工艺加工为材料的环形结构或片材，该片材然后成形为环形结构。
瓣叶框架200可包括例如但不限于任何可弹性变形的金属或聚合物材料，该材料为大体上生物相容性的。瓣叶框架200可包括形状记忆材料，例如镍钛诺、镍钛合金。适用于瓣叶框架200的其它材料包括但不限于其它钛合金、不锈钢、钴镍合金、聚丙烯、乙酰基均聚物、乙酰基共聚物、其它合金或聚合物、或大体上生物相容的任何其它材料，该材料具有足够的物理和机械性质以用作本文所述瓣叶框架200。
瓣叶构造
瓣叶构造300是包括瓣叶310和用于将瓣叶310联接到瓣叶框架200的结构的那部分瓣膜100。根据一个实施例，瓣叶构造300限定毗连的环形圈，该环形圈限定多个瓣叶310和在瓣叶310中的每一个之间的桥区域330。如本文所用，“毗连的”意味着没有断裂或接缝，即，无缝的。每个桥区域限定邻近第一瓣叶310的桥第一端部332和邻近第二瓣叶310的桥第二端部334。当联接到瓣叶框架200时，瓣叶从瓣叶框架200径向向内延伸。瓣叶310中的每一个限定折叠部分324，折叠部分324折叠到并且抵靠于瓣叶框架200的瓣叶框架外侧204上，且联接到瓣叶框架外侧204。桥区域330中的每一个限定桥环338，且在桥环338和相邻的瓣叶310之间具有对合颈部340。对合颈部340能操作成穿过柱狭槽217中的一个，以使得桥环338邻近瓣叶框架200的外部部分，并且瓣叶310从瓣叶框架200径向向内延伸。
包括柔性瓣叶310的瓣叶构造300可由聚合物制成。例如，预成型的聚合物瓣叶可通过从已被切割成类似于图3和图4所示形状的聚合物材料的圆柱体开始制成。
瓣叶构造300也可由聚合物材料的片材制成，该材料已被切割成类似于图3和图4所示形状，并且随后联接到一起成为环形形状。然而，具有接缝的瓣叶构造300可能不具有毗连的无缝构造的优点，毗连的无缝构造可能显示具有更高的抗张强度特性。由保持元件400提供的优点仍然可以被实现。
瓣叶构造300可以被成形的另一种方式(假设使用适合以这种方式成形的瓣叶的材料)是通过压缩或注塑成型。
根据一个实施例，每个瓣叶310在折叠部326处基本上具有等腰梯形的形状，该梯形具有两个瓣叶侧部323、瓣叶基部325和与瓣叶基部325相对的瓣叶自由边缘312，其对应于两个瓣叶窗口侧部223和瓣叶窗口基部225。两个瓣叶侧部323从瓣叶基部325分叉开，其中，瓣叶基部325为基本上平坦的。
根据瓣膜100的其它实施例，每个瓣叶310包括中央区域329和在中央区域329的相对两侧上的两个侧部区域328。中央区域329由基本上等腰梯形的形状限定，该等腰梯形由两个中央区域侧部327、瓣叶基部325和瓣叶自由边缘312限定。侧部区域328中的每一个具有基本上三角形的形状，并且各自由中央区域侧部327中的一个、瓣叶侧部323中的一个和瓣叶自由边缘312限定。
根据另一个实施例，瓣叶窗口可以描述为具有U形形状。瓣叶框架大体上限定就像围绕瓣叶框架环形地延伸的多个U形部分，其限定多个连合柱和多个瓣叶窗口框架部分。
如图4所示，瓣叶310中的每一个具有瓣叶腹部部分322和折叠部分324。当处于加工好的且植入的瓣膜100中时，每个瓣叶310的瓣叶腹部部分322为瓣叶310的操作部分。每个瓣叶310的折叠部分324是用来将瓣叶310固定到瓣叶框架200的两个瓣叶窗口侧部223和瓣叶窗口基部225的那部分。瓣叶框架200的每个瓣叶窗口侧部223和瓣叶窗口基部225装入折叠部(折边)326中，该折叠部(折边)326形成于瓣叶310的瓣叶侧部323和瓣叶基部325中的对应一个的瓣叶腹部部分322和折叠部分324中，如图2所示。每个瓣叶310的瓣叶腹部部分322包括在瓣叶框架200的连合柱210之间的足够的材料，以使得三个瓣叶腹部部分322的瓣叶自由边缘312可在瓣膜100的内部并到(聚在)一起或对合(合上)，以闭合瓣膜100，如图1所示。
在瓣叶310中的每一个之间为桥区域330，如图4、图5A、图5B和图8所示。桥区域330能操作成成形为桥环338，该桥环具有大体上矩形的形状，围绕两条环折叠线336折叠，以便如下文讨论那样在其中包含保持元件400，如图5A、图5B、图6和图8所示。由于环形瓣叶框架200的弯曲，根据一个实施例，两条环折叠线336形成角度α，该角度对应于保持元件侧部402，如图6所示。
根据一个实施例，瓣叶构造300可包括诸如生物相容性聚合物的生物相容性材料，该材料不具有生物来源并且对于特定目的来说足够柔顺和结实。在一个实施例中，瓣叶构造300包括膜，该膜与弹性体结合以形成复合材料。根据其它实施例，构成瓣叶构造300的生物相容性材料包括生物材料，例如但不限于牛心包膜。
瓣叶310的形状可部分地由瓣叶框架200和瓣叶自由边缘312的形状限定。瓣叶310的形状也可由用来制造瓣膜100的结构和过程限定，例如但不限于下文所述那些。例如，根据一个实施例，瓣叶310的形状也部分地取决于利用模制和修剪过程模制瓣叶310以赋予瓣叶310预定的形状。
当瓣叶310打开和闭合时，瓣叶310大体上围绕瓣叶基部325围绕U形部分的瓣叶窗口基部225挠曲。在一个实施例中，当瓣膜100闭合时，每个瓣叶自由边缘312的大体上约一半与相邻瓣叶310的瓣叶自由边缘312的相邻半部邻接，如图1A所示。图1A的实施例的三个瓣叶310在三叉点348处相交。当瓣叶310处于闭合位置时，瓣膜小孔150被封堵，从而停止流体流。
瓣叶构造材料
瓣叶构造300可包括足够柔顺和柔性的任何生物相容性材料，例如生物相容性聚合物。瓣叶构造300可包括膜，该膜与弹性体结合以形成复合材料。根据一个实施例，瓣叶构造300可包括复合材料，该复合材料包括膨胀型含氟聚合物膜和弹性体材料，该含氟聚合物膜包括在纤丝(原纤维)的基质内的多个空间。应当理解，在保留在本公开的范围内的同时，多种类型的含氟聚合物膜和多种类型的弹性体材料可以结合以形成复合材料。还应当理解，在保留在本公开的范围内的同时，弹性体材料可包括多种弹性体、多种类型的非弹性体成分，例如，无机填充剂、治疗剂、射线不可透标记物等。
根据一个实施例，复合材料包括膨胀型含氟聚合物材料，其由多孔ePTFE膜制成，例如，如在授予Bacino的美国专利第7,306,729号中大体上描述的。
用来形成所描述的膨胀型含氟聚合物材料的可膨胀的含氟聚合物可包括PTFE均聚物。在备选实施例中，可使用PTFE、可膨胀的改性的PTFE和/或PTFE的膨胀型共聚物的共混物。合适的含氟聚合物材料的非限制性示例描述于例如以下专利中：授予Branca的美国专利第5,708,044号；授予Baillie的美国专利第6,541,589号；授予Sabol等人的美国专利第7,531,611号；授予Ford的美国专利申请第11/906,877号；以及授予Xu等人的美国专利申请第12/410,050号。
膨胀型含氟聚合物膜可包括用于实现所需瓣叶性能的、诸如孔的任何合适的微结构。可能适合在瓣叶中使用的其它生物相容性聚合物包括但不限于以下的组：聚氨酯、硅树脂(有机聚硅氧烷)、硅-聚氨酯共聚物、苯乙烯/异丁烯共聚物、聚异丁烯、聚乙烯共聚物(醋酸乙烯酯)、聚酯共聚物、尼龙共聚物、氟化烃聚合物以及上述中的每一种的共聚物或混合物。
瓣叶构造材料的另外的示例包括：瓣叶构造包括至少一个含氟聚合物膜层；其中，瓣叶构造包括具有多于一个含氟聚合物膜层的层合物；其中，所述至少一个含氟聚合物膜层为膨胀型含氟聚合物膜层；其中，弹性体包含在膨胀型含氟聚合物膜层内；其中，弹性体包括全氟甲基乙烯基醚和四氟乙烯；其中，膨胀型含氟聚合物膜层包括ePTFE；其中，瓣叶构造包括具有至少一个含氟聚合物膜层和弹性体的复合材料，所述至少一个含氟聚合物膜层具有多个孔，弹性体存在于含氟聚合物膜层中的至少一个的孔中；其中，复合材料包括按重量计在约10％至90％的范围内的含氟聚合物膜；其中，弹性体包括全氟烷基乙烯基醚(PAVE)；其中，弹性体包括四氟乙烯和全氟甲基乙烯基醚的共聚物；其中，弹性体为硅树脂；其中，弹性体为含氟弹性体；其中，弹性体为聚氨酯；并且其中，弹性体为TFE/PMVE共聚物；其中，TFE/PMVE共聚物大致包括在约40和80重量％之间的全氟甲基乙烯基醚和互补地60和20重量％的四氟乙烯；并且其中，瓣叶构造包括硅树脂。
保持元件
保持元件400是能操作成设置在由瓣叶构造300的桥区域330形成的桥环338内的元件，该元件有效地防止桥环338穿过柱狭槽217，以及因此瓣叶构造300在柱外侧处机械联接到连合柱。保持元件400的宽度大于柱狭槽217的宽度。在保持元件400设置在桥环338中的情况下，桥环338将被阻止穿过柱狭槽217。桥环338的大小应紧密地对应于保持元件400的大小，以防止在缝合线松弛或失效的情况中桥区域330的一部分穿过柱狭槽217延伸至瓣膜孔口150。
根据一个实施例，保持元件400限定相对平坦的大体上矩形的形状，以便具有在连合柱210的柱外侧212上的低轮廓。由于环形瓣叶框架200的弯曲，根据一个实施例，保持元件400的各侧部以一角度形成，该角度对应于形成角度α的两条环折叠线336，如图8所示。
根据实施例，保持元件400可以是平坦的、相对平坦的或在内侧上(朝瓣膜的中心)凹面的，以对应于保持元件400将与之邻近的连合柱210的径向外部凸面。每个保持元件400具有与连合柱小孔209对准的多个保持元件小孔408，其中，保持元件400紧贴连合柱210的柱外侧212放置，其中桥区域330的一部分位于保持元件400和柱外侧212之间。例如但不限于缝合线700的固定结构可以用来将保持元件400联接到连合柱210。缝合线可以具有任何合适的材料，例如PTFE、PET和尼龙等。包括缝合线700的针迹可以穿过这些对准的连合柱小孔209和保持元件小孔408和桥区域330，以将每个保持元件400和桥区域330保持到连合柱210。该缝合线700中的一些或全部可以穿过瓣叶310的折叠部分324。在这种情况下，该缝合线700将有助于将瓣叶310的瓣叶腹部部分322固定到瓣叶框架200。
用于保持元件400的合适材料的示例包括：各种生物相容性合金，例如，钛、Elgiloy(埃尔基洛伊耐蚀游丝合金)、MP35N、不锈钢、镍钛诺等；和各种生物相容性工程塑料，例如，乙酰基聚合物、PTFE和PEEK。
瓣叶框架组件
瓣叶框架组件234是瓣叶框架200、瓣叶构造300和保持元件400的组件。瓣叶构造300是包括瓣叶310和用于将瓣叶310联接到瓣叶框架200的结构的那部分瓣膜100。根据一个实施例，瓣叶构造300限定毗连的圆柱体，该圆柱体限定多个瓣叶310和在瓣叶310中的每一个之间的桥区域330。每个桥区域限定邻近第一瓣叶310的桥第一端部332和邻近第二瓣叶310的桥第二端部334。当联接到瓣叶框架200时，瓣叶从瓣叶框架200径向向内延伸。瓣叶310中的每一个限定折叠部分324，折叠部分324折叠到并且抵靠于瓣叶框架200的瓣叶框架外侧204上，且例如利用固定结构联接到瓣叶框架外侧204，该固定结构为例如但不限于缝合线、粘合剂、热结合或其它手段。桥区域330中的每一个限定桥环338，且在桥环338和相邻的瓣叶310之间具有对合颈部340。对合颈部340能操作成穿过柱狭槽217中的一个，以使得桥环338邻近瓣叶框架200的外部部分，并且瓣叶310从瓣叶框架200径向向内延伸。保持元件400设置在桥环338内，从而有效地防止桥环338穿过柱狭槽217。保持元件400可以例如利用缝合线、粘合剂、热结合或其它手段联接到连合柱210。瓣叶310中的每一个的折叠部分324围绕瓣叶框架200的流入边缘折叠，并且例如利用缝合线、粘合剂、热结合或其它手段联接到流入边缘。
根据一个实施例，每个桥区域330围绕保持元件外侧412缠绕到保持元件400中的一个的保持元件内侧414，其中，桥第一端部332从第一方向横跨保持元件内侧414缠绕到竖直地对分保持元件400的分隔线416附近，并且桥第二端部334从相反的方向横跨保持元件内侧414缠绕到分隔线416附近，其中，桥第一端部332和桥第二端部334彼此相邻以限定对合颈部340。
根据一个实施例，瓣叶框架组件234设有用于联接到天然组织环面的装置，并且因此瓣叶框架组件234为假体心脏瓣膜100。在一个实施例中，缝合封套600联接到瓣叶框架组件234，其中，缝合封套能操作成缝合到天然组织环面。在另一个实施例中，包括缝合封套600的基部框架500联接到瓣叶框架组件234。
表征本文提供的一些实施例的有益效果的一种可能的方式是桥区域330为连续构件(即，无接缝或断裂)的效应。趋于将桥区域330拉或拔过柱狭槽217的任何力被构成桥区域330的材料的拉伸强度抵消。在使用期间作用在瓣叶310上的力在连合柱210处最大，该力趋于将瓣叶310从连合柱210拉离。根据这些实施例，在连合柱210处瓣叶构造300与瓣叶框架200的联接不单独依赖于缝合线700，而且依赖于保持元件400，该保持元件防止桥区域330穿过柱狭槽217。应当理解，缝合线通常经过一段时间趋于松弛和失效，尤其是在具有高应力的区域中。在这些实施例中，将桥区域330联接到连合柱210的缝合线700可能松弛或失效，但保持元件400继续防止桥区域330穿过柱狭槽217，从而防止瓣膜100失效。
此外，在瓣膜100的操作期间，保持元件400在桥区域330的一部分与连合柱210的柱外侧212之间提供夹紧力。该夹紧力是保持元件400比柱狭槽217大的结果，这防止了桥区域330穿过柱狭槽217。夹紧力不依赖于缝合线700的强度或缝合线在桥区域330和连合柱210上的张力。
该夹紧力可趋于将力分布在桥区域330上，从而减小可能施加在缝合线700和小孔999处的峰值应力。此外，夹紧力是将力从瓣叶130传递到瓣叶框架200的主要模式，而不是仅仅依赖于瓣叶310到瓣叶框架200的缝合。此外，两条环折叠线336的角度α使得可以在桥环338和相邻的瓣叶310之间将应力基本上相等地分布到对合颈部340上，从而减小对合颈部340中的峰值应力。
根据这些实施例，瓣叶310从瓣叶框架200垂直延伸，如图5所示。瓣叶310在垂直于柱内侧214的方向上从柱狭槽217延伸。这样，瓣叶310表现出朝闭合位置的偏置。这是有益的，因为在血液不断减速或回流的心动周期的阶段中，瓣膜100将趋于较早地闭合。较早的闭合将趋于减少通过瓣膜100的回流。
设计和制造过程(包括各种部件和组装这些部件的方式)通过更均匀地分布荷载而大大地减小在瓣叶框架与瓣叶接头处的可能的应力集中。这些设计和制造过程方面也(1)减小大面积且苛求的缝合的负担，(2)增加瓣膜制造结果的一致性，并且(3)由于所有上述因素而增加所得到的瓣膜的使用寿命。
代替或除了缝合线之外，化学结合和/或粘合剂可在瓣叶框架200和瓣叶构造的折叠部分324之间使用。
桥区域330以多种方式穿过柱狭槽217。根据一个实施例，桥区域330成形为狭窄的桥环338，该桥环从瓣叶框架内侧202穿过柱狭槽217到达瓣叶框架外侧204。保持元件400可以接着被插入桥环338中，以防止桥环338向后穿过柱狭槽217。
根据实施例，瓣叶框架200、瓣叶构造300和保持元件400具有匹配且径向对准的小孔以用于接纳缝合线。折叠部分324和包含保持元件400的桥区域330通过缝合穿过这些匹配的小孔而联接到瓣叶框架。图7中的虚线示出了说明性的缝合线图案。缝合工作量很小，并且对技术要求不高。
基部框架
基部框架500为大体上环形的构件，其限定具有基部框架内侧502和基部框架外侧504的基部框架腔体550，如图3和图4所示。基部框架500可以为瓣叶框架200提供结构上的承载支撑。此外，基部框架500可被构造成在植入部位处提供受体组织的形状配合的接合(positive engagement)。
根据一个实施例，基部框架500限定远离基部框架流入边缘520延伸的多个三角形区域526。瓣叶框架200可包括对应的三角形开口256，三角形开口256由瓣叶框架200的相邻的瓣叶窗口222的两个瓣叶窗口侧部223限定，这两个侧部限定在瓣叶框架流入边缘220上的等腰三角形的两个边。三角形开口256能操作成将基部框架500的三角形区域526接纳于其内。
基部框架500可包括大体上生物相容的任何金属或聚合物材料。例如，基部框架500可包括例如但不限于下列的材料：镍钛诺、钴镍合金、不锈钢和聚丙烯、乙酰基均聚物、乙酰基共聚物、ePTFE、其它合金或聚合物、或任何其它生物相容性材料，该材料具有起到本文所述作用的足够的物理和机械性质。
基部框架500可以被蚀刻、切割、激光切割或冲压成材料的管或片材，片材接着成形为环形结构。
根据实施例，基部框架500可被构造成向植入部位提供形状配合的接合。在一个实施例中，瓣膜100还包括围绕基部框架500联接的缝合封套600，如图1A和图1B所示，其能操作成接纳缝合线，以便缝合到组织孔口。应当理解，根据实施例，用于植入假体瓣膜的常规外科技术可用来植入瓣膜100。
应当理解，用于将瓣膜100联接到植入部位的其它元件或手段是预料中的。举例来说，而非限制，诸如机械和粘合剂手段的其它手段可以用来将瓣膜100联接到合成或生物导管。
在另一个实施例中，瓣膜100还包括基部框架500，如图3和图4所示。基部框架500联接到瓣叶框架200的瓣叶框架流入边缘220。基部框架500设有基部框架小孔508，其可以用来利用缝合线700将基部框架500缝合到瓣叶框架200。单独的瓣叶框架200和基部框架500的优点在于，它们可以具有不同的物理特性。举例来说，相比于刚性较大的瓣叶框架200，支撑瓣叶310的刚性相对较低的瓣叶框架200更有可能减小通过打开和闭合瓣叶130遇到的荷载。具有刚性相对较低的性质的瓣叶框架200可以减小瓣叶加速度并减小在瓣叶310上的闭合应力。基部框架500可以刚性更大，这将更适合缝合到天然组织孔口。基部框架500可以抵抗在例如植入部位处可能遇到的压缩力。
在瓣膜100的实施例中，基部框架500和瓣叶框架200的添加提供了用于为基部框架500和瓣叶框架200中的每一个提供适合特定目的的不同的物理性质的手段。根据一个实施例，基部框架500相比瓣叶框架200刚性(刚度)更大。当接合到例如但不限于组织孔口的植入部位时，基部框架500刚性足够大，以免在生理荷载下显著变形。
基部框架500和瓣叶框架200的物理性质部分地取决于基部框架500和瓣叶框架200的大小、形状、厚度和材料性质。
如本文所用并且如在工程中通常所用，“刚性的”和“刚度”是由基部提供的对变形的抵抗力的量度。“刚性的”和“刚度”主要随材料性质、物体的形状和物体的边界条件变化。瓣叶框架200的刚度(参见图1A)可以通过本领域已知的许多方法测量。根据一种方法，缆线可以联接到三个连合柱210中的每一个，并且并到一起，以便在瓣叶框架由基部框架500保持的情况下允许沿着瓣叶框架的轴线同时牵拉这些缆线。使三个连合柱朝该轴线偏转所需的缆线上的力的量提供了刚度的量度。可以对基部框架500进行相同的操作，其中缆线联接到基部框架上的三个等间距的点，例如三角形区域526的顶点，如图4所示。
缝合封套
瓣膜100可以设有邻近基部框架500的缝合封套600，如图1A和图1B所示。缝合封套600能操作成提供接纳用于联接到植入部位的缝合线的结构。缝合封套600可包括任何合适的材料，例如但不限于双重丝绒聚酯和硅树脂。缝合封套600可以围绕基部框架500周向地定位或从基部框架500悬垂在瓣周。缝合封套600可包括填充材料，例如但不限于硅树脂环和/或PTFE毡。
方法
根据一个实施例，一种制造假体瓣膜的方法包括获得管，该管包括膨胀型PTFE复合物的一个或多个层。切割瓣叶构造，该瓣叶构造包括多个瓣叶，每个瓣叶通过桥区域与管分离。提供在瓣叶的折叠部分中的折叠小孔和在桥区域中的桥小孔。获得多个保持元件，每个保持元件限定保持元件小孔。将桥区域中的每一个折叠成桥环，并在每个桥环和两个相邻瓣叶之间限定对合颈部，桥环径向延伸远离管轴线。将保持元件设置到桥环中的每一个内。将每个保持元件缝合到相应的桥环，使缝合线穿过桥小孔和与桥小孔对准的保持元件小孔。从金属管切割瓣叶框架，该金属管限定瓣叶框架窗口和在瓣叶框架窗口之间的连合柱，其中每个连合柱限定柱狭槽，该柱狭槽尺寸设计成接纳桥区域的两倍厚度。在瓣叶窗口框架中提供瓣叶窗口框架小孔，并在连合柱中提供柱小孔。利用邻近柱外侧的保持元件将每个对合颈部设置在相应的柱狭槽中，并且将瓣叶设置在瓣叶框架中。将保持元件小孔与柱小孔对准。将每个保持元件缝合到相应的连合柱，使缝合线穿过保持元件小孔和与该保持元件小孔对准的柱小孔。将每个瓣叶的折叠部分沿着瓣叶框架流入边缘且抵靠瓣叶框架外侧折叠，将折叠小孔与瓣叶窗口框架小孔对准。并且将每个折叠部分缝合到相应的瓣叶窗口框架，使缝合线穿过折叠小孔和与该折叠小孔对准的瓣叶窗口框架小孔。
根据一个实施例，该方法还可包括：提供织物的条，将织物缠绕和缝合在瓣叶框架上，以在瓣叶框架和瓣叶构造之间提供衬垫；以及将织物修剪到距瓣叶框架的瓣叶框架流出边缘大约3mm处。
根据一个实施例，该方法还可包括：从金属管切割基部框架，该金属管限定基部框架小孔；以及将基部框架联接到瓣叶框架的瓣叶框架流入边缘。
根据一个实施例，该方法还可包括：提供织物管；以及将织物管沿着其流动轴线插过基部框架。将织物的织物流出边缘折叠在基部框架的基部框架流出边缘上。使用穿过基部框架中的基部框架小孔的缝合线将织物缝合在位。将织物管的织物流入边缘内翻到基部框架上。使用沿着基部框架的流入边缘穿过基部框架小孔的缝合线将织物管缝合在位。将缝合封套插件设置在由内翻的织物管限定的口袋内部，并且将织物管塞到到基部框架和缝合封套插件之间，使得织物管的所有松弛围绕缝合封套被移除。将瓣叶框架放置成与基部框架同轴且邻近基部框架并且在织物管的内部。在距瓣叶框架流出边缘大约5mm处修剪织物管，并且使用穿过相应的瓣叶窗口框架小孔和基部框架小孔的缝合线将瓣叶框架在瓣叶窗口基部处缝合到基部框架。将织物管的修剪过的边缘折叠到瓣叶框架流出边缘上，将修剪过的边缘塞到其自身下方以隐藏任何磨损边缘，并且将织物管缝合到瓣叶框架上的织物。
示例
举例来说，瓣膜的一个实施例制备如下：
外科假体心脏瓣膜通过以下方式构造。使用CO2激光器按照图3所示图案从瓣叶试样切割包括折叠小孔308和桥小孔309的瓣叶构造300。
将图3所示由PEEK制成的三个保持元件400缝合到瓣叶构造300的桥区域330的桥环338上，如图5和图6所示。保持元件400设有保持元件小孔408，其与瓣叶构造300上的桥小孔309对准。所得到的组件的局部视图在图2中示出。
从具有25mm外径和0.4mm壁厚的钴铬(MP35N)的管激光切割出分别包括瓣叶框架小孔208和基部框架小孔508的瓣叶框架200和基部框架500，并且电解抛光，如图3所示。将框架在乙醇的超声波浴槽中洗涤以移除污染物。将聚酯针织织物的三个条缠绕并缝合在瓣叶框架上，以在瓣叶框架200和瓣叶构造300之间提供衬垫。提供足够大的连合柱210的柱狭槽217(大约0.254mm)，以在桥区域330处容纳瓣叶构造300。将剩余的聚酯针织织物在距图4所示瓣叶框架200的瓣叶框架流出边缘224大约3mm处修剪掉。通过利用在柱外侧212上的保持元件400将每个对合颈部340滑入柱狭槽217中，将带有保持元件400的瓣叶构造300放置在瓣叶框架200上，如图2所示。将保持元件小孔408与瓣叶框架200上的瓣叶框架小孔208对准，并且利用缝合线700缝合在位，如图6所示。瓣叶构造300包括沿着附连边缘的折叠部分324和折叠小孔308。将折叠部分324沿着瓣叶框架200的瓣叶框架流入边缘220紧贴瓣叶框架外侧204向上折叠，其中折叠部分324中的折叠小孔308与瓣叶框架200的瓣叶框架小孔208重合并且用缝合线700缝合在位，如图7所示。
将具有约24mm的直径和至少10cm的长度的聚酯针织织物的管沿着其流动轴线插入穿过基部框架500。将聚酯针织织物的织物流出边缘折叠在基部框架500的基部框架流出边缘524上，并且使用穿过基部框架500(未示出)中的基部框架小孔508的缝合线缝合在位。将聚酯针织织物管的织物流入边缘内翻到基部框架500上，并且使用穿过沿着基部框架500的基部框架流入边缘520的基部框架小孔508的缝合线700缝合在位。将硅树脂缝合封套插件放置在基部框架500上和内翻的聚酯针织织物管的内部。将聚酯针织织物管塞在基部框架500和缝合封套插件之间，使得围绕缝合封套600的所有松弛被移除。
将包括瓣叶框架200、瓣叶构造300和保持元件400的瓣叶框架组件234同轴地放置在基部框架附近和聚酯针织织物管内部。将聚酯针织织物管修剪至距瓣叶框架流出边缘224大约5mm。利用在瓣叶框架200的三个瓣叶窗口基部225中的每一个处的三根缝合线700将瓣叶框架200在瓣叶窗口基部225处缝合到基部框架500。将聚酯针织织物的修剪过的边缘折叠到瓣叶框架流出边缘224上。将修剪过的边缘塞到自身下方，以隐藏任何磨损边缘，并且缝合到瓣叶框架上的聚酯针织织物。
前面的描述中已叙述了许多特性和优点，包括各种备选方案连同装置和/或方法的结构和功能的细节。本公开仅仅意图为示例性的，并且因此并非意图详尽列举。本领域的技术人员显而易见的是，可以对由表达所附权利要求的术语的广泛、一般含义所指示的全部内容进行各种修改，尤其是在包括在本公开的原理内的组合在内的结构、材料、元件、部件、形状、尺寸和零件的布置方面。只要这些各种修改不脱离所附权利要求的精神和范围，它们就意图被涵盖在权利要求中。

Claims (20)

1.一种假体瓣膜，包括：
瓣叶框架，其具有中心轴线、内侧和外侧，所示瓣叶框架包括多个连合柱以及分别位于相邻的连合柱之间的多个瓣叶窗口；
瓣叶构造，其包括多个瓣叶和在所述瓣叶中的每一个之间的桥区域，所述瓣叶从所述瓣叶框架向内延伸，所述瓣叶中的每一个限定折叠部分，所述折叠部分具有多个折叠小孔，所述折叠部分中的每个折叠到所述瓣叶框架的流入边缘上；
多个固定结构，所述固定结构利用多个所述折叠小孔将所述瓣叶构造的所述折叠部分固定到所述瓣叶框架。
2.根据权利要求1所述的假体瓣膜，其特征在于，所述瓣叶框架包括位于所述瓣叶窗口内的多个框架小孔，多个瓣叶中的每个瓣叶的多个折叠小孔中的每个与多个框架小孔中的一个对准，多个固定结构穿过对准的多个框架小孔和多个折叠小孔，以将所述折叠部分联接到所述瓣叶框架的所述瓣叶窗口。
3.根据权利要求1所述的假体瓣膜，其特征在于，每个瓣叶的所述折叠部分围绕所述瓣叶框架的流入边缘折叠且联接到瓣叶框架的所述外侧。
4.根据权利要求1所述的假体瓣膜，其特征在于，所述多个连合柱中的每个包括第一柱腿和第二柱腿，所述第一柱腿和所述第二柱腿从多个瓣叶窗口中的一个朝向连合末端延伸，所述连合末端与相应的连合柱相关联，每个连合柱的所述第一柱腿和所述第二柱腿彼此间隔开，从而限定柱狭槽。
5.根据权利要求1所述的假体瓣膜，其特征在于，所述瓣叶构造形成为毗连的圆柱体。
6.根据权利要求1所述的假体瓣膜，其特征在于，所述多个固定结构包括多根缝合线。
7.根据权利要求1所述的假体瓣膜，其特征在于，所述多个固定结构包括粘合剂或者热结合。
8.根据权利要求1所述的假体瓣膜，其特征在于，所述瓣叶构造包括至少一个含氟聚合物膜层。
9.根据权利要求8所述的假体瓣膜，其特征在于，所述至少一个含氟聚合物膜层为膨胀型含氟聚合物膜层。
10.根据权利要求9所述的假体瓣膜，其特征在于，弹性体包含在所述膨胀型含氟聚合物膜层的多孔结构内，涂布在所述膨胀型含氟聚合物膜层的一侧或两侧上，或者为涂布在所述膨胀型含氟聚合物膜层上和包含在所述膨胀型含氟聚合物膜层内的组合。
11.一种制造假体瓣膜的方法，包括：
在多个瓣叶的多个折叠部分中形成多个折叠小孔；
将所述多个折叠部分与瓣叶框架对准，所述瓣叶框架包括多个连合柱以及分别位于相邻的连合柱之间的多个瓣叶窗口；以及
利用多个固定结构和所述多个折叠小孔将所述瓣叶构造的所述折叠部分固定到所述瓣叶框架。
12.根据权利要求11所述的方法，其特征在于，所述瓣叶框架包括位于瓣叶窗口内的多个框架小孔，其中，多个瓣叶中的每个瓣叶的多个折叠小孔中的每个与多个框架小孔中的一个对准，所述多个固定结构穿过对准的多个框架小孔和多个折叠小孔，以将所述折叠部分联接到所述瓣叶框架的所述瓣叶窗口。
13.根据权利要求11所述的方法，其特征在于，还包括围绕所述瓣叶框架的流入边缘折叠每个瓣叶的每个折叠部分。
14.根据权利要求13所述的方法，其特征在于，还包括将每个瓣叶的每个折叠部分联接到所述瓣叶框架的外侧。
15.根据权利要求11所述的方法，其特征在于，将瓣叶构造形成为毗连的圆柱体。
16.根据权利要求11所述的方法，其特征在于，所述多个固定结构包括多根缝合线。
17.根据权利要求11所述的方法，其特征在于，所述多个固定结构包括粘合剂或者热结合。
18.根据权利要求11所述的方法，其特征在于，所述瓣叶构造包括至少一个含氟聚合物膜层。
19.根据权利要求18所述的方法，其特征在于，所述至少一个含氟聚合物膜层为膨胀型含氟聚合物膜层。
20.根据权利要求19所述的方法，其特征在于，弹性体包含在所述膨胀型含氟聚合物膜层的多孔结构内，涂布在所述膨胀型含氟聚合物膜层的一侧或两侧上，或者为涂布在所述膨胀型含氟聚合物膜层上和包含在所述膨胀型含氟聚合物膜层内的组合。
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