CN1147275C - 心脏瓣膜假体 - Google Patents

心脏瓣膜假体

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CN1147275C
CN1147275C CNB988020084A CN98802008A CN1147275C CN 1147275 C CN1147275 C CN 1147275C CN B988020084 A CNB988020084 A CN B988020084A CN 98802008 A CN98802008 A CN 98802008A CN 1147275 C CN1147275 C CN 1147275C
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prosthese
lobule
valve
framework
pillar
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CN1244107A (zh
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戴维·约翰·惠特利
ϣ
约翰·费希尔
戴维·威廉斯
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International Open Ltd
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Aortech Europe Ltd
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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
    • 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

Abstract

本发明提供一种假体瓣膜，瓣膜具有带有三个支柱和三扇形凹口的大体为环形的构架。构架与由通过瓣膜的血液流动轴线限定的对称轴线三重对称。构架的外表面是直径为D的大体上的圆柱形。每个小叶邻近它的自由边缘具有截头的球形表面。球形表面相切地连接到截锥表面上。截锥的半角大约37.5°。球体的半径大约D/2-0.5(mm)。小叶表面与对称轴线成轴对称，而对称轴线与瓣膜构架的轴线和血液流动方向垂直。

Description

心脏瓣膜假体
技术领域
本发明涉及医学移植物，尤其涉及心脏和血管的移植物和假体。
背景技术
在哺乳动物中，心脏是重要的器官，它负责使身体的各个部分维持足够的血液流动(从而提供足够的氧和营养)。瓣膜可防止血液通过心脏回流。
一个或多个的心脏瓣膜发生机能障碍具有严重的医学后果。心脏瓣膜发生机能障碍可能是先天缺陷或疾病导致的损害或退化的结果。发生机能障碍是由瓣膜的狭窄或逆流(或两者的结合)而引起的，从而导致瓣膜上游的高压力。
至今，处理一些心脏瓣膜机能障碍的唯一方法是更换不正常的瓣膜。这种瓣膜更换手术的费用昂贵并且需要特殊的便利条件来进行打开心脏的外科手术。更换损坏的人造瓣膜带有更多的危险，并有进行重复手术次数的实践限制。这就使得对任何一个更换瓣膜的设计及使用寿命显得非常重要。
猪的主动脉瓣膜在病人身上可以使用许多年，并且已经提出把猪的肺瓣膜用在病人身上(如参看Pro Medica国际有限公司的专利申请EP-A-0,402,036)；但是，由生物材料制成的瓣膜寿命短，并且一般在较年轻的病人身人植入10年之内必须进行更换。
在第三世界的国家里，风湿热仍然流行，因此对年轻病人进行更换瓣膜的问题是相当多的。抗凝血剂(为机械膜所需的)常常是不可行的；加速钙化(年轻人中的生物瓣膜的问题)排除了生物代替品的使用。
在西方世界，人类寿命增长的趋势导致需要心脏瓣膜更换的病人相应地增加。因此增加了对既具有延长的使用寿命又具有在接受者内较低的血栓危险的心脏瓣膜假体的需求。
包括一个平行于血液流动方向布置的环形构架的传统弹性小叶心脏瓣膜是公知的。该环形构架一般具有三个支柱，这三个支柱沿下游方向延伸从而在支柱之间限制出三个大体是U形的开口或扇形凹口。小叶一般沿着扇形凹口的边缘方向而连接到支柱之间的构架上，但是在邻近支柱的下游端的小叶自由边缘处没有连接起来。
发明内容
根据本发明提供一种心脏瓣膜假体，该瓣膜假体包括构架和连接到构架上的两个或多个小叶，其中，至少一个小叶包括：一个大体具有一球形表面的第一部分，和/或一个大体具有一锥形表面的第二部分。
各个表面最好局部是锥形或球形。
该假体可以是人造瓣膜，并可以在心脏(或其它血管组织)中沿特定方向定向，从而使得血液在通过组织的方向上流动且可防止回流。该构架最好具有大体的圆形横截面，并带有两个或多个从基体开始沿相同方向延伸的支柱(该支柱的数量与小叶的数量相同)。该假体最好随着沿下游方向延伸的构架的支柱来定向，以便由基体形成的瓣膜开口保持敞开。小叶安装到支柱之间的构架上，并且每个小叶具有一个邻近支柱端部的自由边缘，它们可以密封在一起以关闭支柱端部的瓣膜。
锥形部分最好位于邻近假体的基体，而球形部分最好位于邻近自由边缘。这是有利的，因为小叶边缘处的球形表面比平面或锥形表面更有效地密封，而一旦邻近血液压力增加时，瓣膜基体处的锥形部分比等效的球形部分更容易打开。
由于锥形部分首先对瓣膜上游侧的压力增加起反应，因此体现本发明的瓣膜具有较小的打开阻力。在关闭时，瓣膜下游侧的增大压力促使小叶的自由边缘一起大体平行地布置，因此提高了小叶之间的密封并减少了通过瓣膜的血液回流。
在瓣膜关闭并且下游压力比上游压力大时，邻近小叶基体的球形部分也有利于应力分布。
小叶可以(但不必)是相同的。
小叶最好总共有三个，且构架包括三个支柱。
小叶最好是弹性的。
小叶在第一(球形)部分和第二(锥形)部分之间有一个限定边缘，或者换句话说，这两个部分之间的边缘例如可通过采用与锥形部分配合的、半径逐步增大的球体来逐渐形成。只要小叶的自由边缘(或它的一部分)具有大体的球形表面就是可接受的。
在一个实施例中，小叶延伸超出了构架支柱的顶部。
小叶可包括任何生物稳定的、生物适应的热塑弹性体，该弹性体包括但不限于任何聚氨酯或硅酮的弹性体或者任何以这些成分为基础的共聚物或混合物。
制作方法可以是任何一种合适的方法，它不仅包括浸渍模塑法，而且还包括注模法、传递模塑法和类似方法。
小叶最好包括生物稳定聚氨酯，如ELASTEON-CSIRO、CHRONOFLEX或TECOTHANE，并进行浸渍模塑，从而使小叶与支撑构架和支柱成一整体。
小叶大约100-200μm，但是厚度可以随着所使用材料的不同而改变。由于小叶自身的厚度可以变化，因此包括厚壁区和邻近的薄壁区。可以设计从厚壁区到薄壁区的隆起部和/或平滑扩大部。
小叶表面最好轴线对称，而对称轴线垂直于瓣膜构架的轴线和血液流动的预定方向。在构架直径为距离D(mm)处，球体半径最好位于D/2(mm)和(D/2)-2(mm)之间。
锥形部分大体是截头的并具有一个30°到45°范围内(最好是37.5°)的半角。
构架在内侧和外侧是平行的或稍稍渐缩，因此允许少量分支流动。
打开瓣膜所需的压力由公式Et3/R来定义，这里的E是弹性模量、t是小叶的厚度、R是弯曲部分的半径。
小叶中心的弯曲部分的反向也有利于瓣膜打开。
假体具有结合成一体的供收集气体用的逸出通道，例如构架和/或一个或多个小叶上的血孔，该通道可选择地靠近每个小叶的基体处，并通过构架通向流入面，用于排出子小叶(sub-leaflet)空间的气体。
带有植入缝线并保护瓣膜免受支柱损害的装置是有用的。这可采取与支柱的尖端连接的简单可抽出的缝线或更复杂的伞形弹性聚氨酯保护装置(未示出)的形式，该保护装置可以塌缩并通过二尖瓣假体取出。
可使用金属构架，并且构架可浸涂有聚合物和有利于提高金属—聚合物的粘附性的物质。虽然任何可植入的金属材料如不锈钢或钴铬合金是适合的，但该金属也可以是钛或钛合金。
另外，聚合物材料可用于构架。两个优选方案是采用刚性聚氨酯和PEEK、聚醚醚酮。另外的聚合物是Relrin  (聚醛树脂)、聚乙烯和聚砜。可使用任何刚性或半刚性的热塑性聚合物如聚氨酯、聚醚醚酮、聚醛树脂、聚乙烯、聚砜、聚丙烯或类似材料。
用来提高生物适应性的表面改进大体上可以包括与医疗器械技术有关的这些有用改进中的任何一个。
表面改进可以控制瓣膜材料和血液之间的相互作用，因此防止了蛋白质的吸附作用、血小板的粘附作用和活性化、血凝固级联的活性化和钙化作用。最好对瓣膜的任何表面进行喷涂，主要包括但不局限于小叶材料。
最有可能引起蛋白质吸附作用减少的表面改进是把磷酯附着到聚合物上，其原理是磷酯如磷酸胆碱附着到聚合物的表面上，这个薄层模拟细胞表面并防止血浆蛋白质的吸附作用。由于这种吸附作用是血液—聚合物相互作用的第一种情况，这种相互作用引起与凝固级联和血小板的所有反应，因此抑制该过程可延迟或防止其它效果。应用公知的技术来喷涂任何形式的人造心瓣膜。为了把吸附到它表面上的血浆蛋白质减少到最小，用于瓣膜结构上的聚合物可涂有任何生物(biomimetic)物质如蛋白质、糖蛋白或磷酯类似物。
另一种可能性包括把抗体吸附到表面上，以控制被吸收的蛋白质的特性。例如，人们知道盖有一层清蛋白的表面比盖有纤维蛋白原的表面形成的血栓少得多。已尝试用这些蛋白质喷涂聚合物，但是产生了许多与使用蛋白质有关的免疫问题，而这些蛋白质有多种来源而不是来自宿主。较好的方法是采用抗清蛋白的抗体，抗清蛋白的抗体附着到该表面上，以致当材料与病人的血液产生接触时，它们自己的清蛋白牢牢地附着在接合的抗体上。
血小板倾向于与所有的外表面相互作用，但是可通过对表面组成和性能的控制来使这个过程减少到最小。防止血小板附着到表面上并且防止任何附着的血小板在这个表面上或附近被活化是重要的。有利的表面改进过程包括把亲水分子附着到聚合物表面上。聚乙二醇或其它类似物质可以共价地附着到诸如聚氨酯的聚合物上，而所产生的亲水性将减少细胞附着的倾向性。
也可通过采用附着到表面上的药理学的激活剂来抵抗血小板的附着性。为此把药品如前列腺素、肝素、水蛭素、t—纤维蛋白溶酶原激活剂和尿激酶附着到机能化的聚合物表面上或包含成作为聚合物的浸沥或扩散成分。已经知道这些分子在它们作用在血小板膜上和/或它们作用在与这些膜相互作用的凝固级联中的组分上的过程中具有抗血小板活性，因此可减少血小板的附着和激活。
假体的一个或多个部分可以是透明的。在制造本发明假体瓣膜中使用的特别优选材料是以第5,393,858和5,403,912号美国专利、第PCT/AU97/00619号国际专利申请和第P07002、P07616和P07878号澳大利亚临时专利申请公开的材料为基础。
附图说明
参照附图以示例的方式来描述本发明的一个实施例，其中：
图1a和1b以透视图的方式表示一个瓣膜；
图2是图1中的瓣膜的透视图，示出了球形部分和锥形部分；
图3是穿过图1和图2中的瓣膜小叶的剖视图；
图4是图1瓣膜的侧剖视图；
图5是瓣膜打开时的透视图；
图6是构架的平面和透视图；
图7是第二种瓣膜的透视图；
图8是图7中的瓣膜构架的透视图；
图9以透视图的方式表示了图7中的瓣膜的套；
图10是图7瓣膜的缝合环的透视图；
图11是图8中的构架的局部剖开的透视图；
图12是图7中的瓣膜的小叶的侧剖视图；
图13是小叶的平面图(a、b、c和d)和表示可能有的肋结构的横截面图(e)；以及
图14是图7中瓣膜的整体模制的小叶的透视图。
具体实施方式
现在参照附图，本发明的假体具有大体为环形的构架1，该构架1具有3个支柱1P和3个扇形凹口1S。瓣膜构架1最好由刚性聚合物如聚醚醚酮或高模量聚氨酯来形成，并且与对称轴线三重对称，该对称轴线由血液流过该瓣膜的轴线限定。构架1的外表面大体是直径为D的圆柱形，并分叉至支柱P的尖端。对于给定直径D而言，瓣膜构架1的厚度一般为0.05D。
3个扇形凹口1S和3个支柱1P环绕着该构架成120°间隔均匀地隔开。小叶10沿着每个扇形凹口1S的自由边缘安装，并由邻近的支柱1P来支撑。因此3个小叶10也环绕着构架1成120°间隔均匀地隔开。
每个小叶10是相同的，并具有邻近它的自由边缘的截头球形表面10S。球形表面10S相切地连接到截锥表面10C上。截锥半角是37.5°，但是也可以是如图3所示的30°到40°范围内的任何一个角度。球体的半径接近D/2-0.5mm，但是也可以是处于D/2到D/2-2(mm)范围内。小叶表面与对称轴线成轴对称，而对称轴线垂直于瓣膜构架和血液流动的轴线。
每个小叶的自由边缘位于垂直于预定血液流过瓣膜的轴线(Z)的平面XY。图3b表示位于XY平面上的小叶几何形状，及图4表示位于XZ平面上的小叶几何形状。
瓣膜被放置在诸如血管组织中，支柱和小叶的自由边缘指向下游。小叶的几何形状设计成促使瓣膜小叶从瓣膜的基体打开。瓣膜上游的压力增加引起小叶基体处的锥形部分10C首先分叉。锥形表面以最小阻力非常容易地弯至打开位置，因此可在非常小的上游压力作用下打开瓣膜。锥形部分10C的分叉促使球形部分10S分叉。
在锥形部分10C的上游压力作用下，小叶10的球形部分10S容易跟着分叉打开，并且在增加的下游压力作用下，相互之间的密封比锥形面或平面的密封更加有效。
小叶的密封和瓣膜的能力可以通过下面方式来得到进一步的提高：把小叶延伸到超出瓣膜支柱顶部1-2mm，稍微地改变支柱上方的小叶几何形状使小叶直接相对。
图7-13表示本发明瓣膜的第二实施例。第二瓣膜20具有：由弹性聚氨酯制成的并位于支撑构架21上的三个小叶30、小叶30的保护装置24和外科手术插入用的缝合环25。
构架21具有3个支柱21P，每个支柱21P从基体21B处逐渐变细直到成为一个尖端。该支柱和基体限定3个扇形凹口21S。基体21B的下(上游)边缘弄成扇形以大体上与安放小叶30的扇形凹口21S一致。
金属构架21是优选的，并能提供最大强度和最小构架厚度；构架21可以浸涂有聚合物。小孔、栅格和网格表面可以提高金属/聚合物的粘性。
构架21的主要功能是支撑小叶30的基体，使小叶30的基体具有一个稳定和可预知的几何形状。构架上的小叶的起始位置应处于最佳角度，从而在小叶运动时使弯曲应力最小，并尽可能大地把转换区域从完全弹性伸展到完全刚性。把小叶30无缝地安装到构架21是必要的，以使小叶30从构架21分开的可能性减少到最小。
构架21的柔性度是必要的，以减少小叶上的应力，但是防止蠕变也是重要的。
外套24布置成环绕柱子和构架，并给小叶30提供保护以防与邻近的组织、尤其是在二尖瓣瓣膜情况下的心室的心肌和主动脉瓣膜情况下的主动脉壁相接触。该外套延伸到支柱边缘以外。
构架21还为缝合环25提供一个安全的固定支座以便外科手术插入。另外，在瓣膜的植入过程中构架为安装系统提供一个暂时支撑以便进行外科手术操作。
理想地，构架21应该以这种方式连接到缝合环25上：外科医生可以旋转植入的瓣膜20从而选择构架支柱的最佳位置。
理想地，为了在外科植入过程中使损伤小叶的危险减少到最小，以及为了有利于准确而又安全地放置缝合环25，构架21应与缝合环25是可分开的并在完成缝合环25插入之后进行外科手术时容易而又安全地连接起来。
瓣膜的总高度应该与这样的高度一样低，即该高度与较好的小叶稳定性和适当的应力相适应。小叶30的基体应位于尽可能地靠近瓣膜的流入面，且缝合环25应距离流入面一个距离安装以便尽可能地减少支柱伸出。
小叶30的几何形状最好是优化成在打开和关闭的过程中能使应力均匀扩散，并具有较大的小叶30的接合区。小叶30最好在低横向瓣膜(transvalvar)压力水平打开，从而在二尖瓣位置以小尺寸来满意地使用，以及获得最佳的血循环动力功能。在压差方面，流体动力性能比得上双小叶机械瓣膜而不是生物假体瓣膜的性能，而在回流方面比得上生物假体瓣膜的性能。
弹性三小叶瓣膜实际上具有两个小叶的稳定位置，即打开和关闭这两个位置。打开位置和关闭位置之间的转换涉及一个快速弯曲的过程，该过程使小叶承受形状的快速变化，该小叶伴随有小叶材料的突变角度和高应力聚中区。通过仔细地设计小叶的几何形状可以使瞬时的、反复性的高应力源减小到最少。
小叶30可以形成带有对优化的中间弯曲位置的“记录”，该优化中间弯曲位置使得它的运动循环的最易损坏部分的内部应力最小。小叶30可以浸渍模塑在“中间弯曲”位置中。这就提供了一个解决在整个构架21内浸渍模塑三个小叶30的问题的方法。而且，它还有助于确保：弯曲过程是可预测的和可控制的，同时在弯曲时使应力最小和分散。为了确保瓣膜在卸荷时处于关闭位置，因此在瓣膜处于关闭位置时可采用第二次浸渍模塑。在关闭位置上通过热处理可以得到同样的效果。无论采用哪种方法，在小叶上只有足够的记录被导入以使其关闭，但是还没有到打开横向瓣膜(transvalve)压力梯度水平所需的那么多，而该梯度是小叶在关闭位置时模制所具有的。它也有助于在打开位置上进行第三次浸渍模塑(或者进一步进行热处理)从而使开口瓣膜具有均匀的、无皱折的几何形状。通过调整浸渍溶液的浓度来控制附加浸渍镀层厚度。
通过在聚氨酯的小叶30内设置加强肋26来提供加强小叶30和控制弯曲这两者的另一个选择。这具有使小叶30在一个方向(肋26的方向)比垂直方向更坚硬。先天的主动脉瓣膜(和猪的生物假体瓣膜)的各向异性性能可通过聚氨酯小叶上的环形肋来模拟。这个方法可以推广到采用栅条形肋26或均匀同心布置的环形或椭圆形肋26，肋26以可预测的形式影响小叶弯曲。这种肋26可以形成在浸渍模塑瓣膜中，如通过仔细地蚀刻小叶30的浸渍模型来形成。为了防止潜在的紊流，需要在小叶的流出表面而不是在流入表面上形成肋26。
小叶30可以是分开模塑而成，以便于使小叶30有足够表面积和作为小叶30的固有部分的聚氨酯肋结构(从小叶的流出面伸出)，并用定位销和定位孔把小叶30装配到构架21上。另外，作为一个完整单元来浸渍模塑所有的三个小叶是可能的，而这个完整单元可借助于定位销和构架上的相应孔而连接或固定到构架上。套24可以包括一个压紧装置并延伸到支柱以外从而有助于保护小叶不受心肌壁或主动脉壁的冲撞。
示例1
一个瓣膜的制造如图2所示。基体具有大约23.8mm的外径，而其内径为22.4mm。
支柱从构架的基体延伸大约17mm，在这个实施例中的每个支柱的顶部宽度是1.4mm，而厚度为0.7mm。
瓣膜构架由聚醚醚酮制成并涂有0.2mm厚的ELASTEON CSIRO。
为了制造这个涂层瓣膜，把构架放置在一固体墩上方，而小叶通过浸渍模塑来形成，从而把它们结合到构架上。小叶的材料是ELASTEON CSIRO聚氨酯，其厚度在100-200μm之间。
本发明的假体瓣膜的另一示例包括采用高模量聚氨酯构架(E＞500MPa)或者采用弹性模量在5-15MPa范围内的CHRONOFLEX或者TECOTHANE聚氨酯。
在没有脱离本发明范围内可对本发明进行各种变形和改进。例如，构架可由生物适应聚合物、金属或者复合物形成。构架可涂有聚氨酯从而使得与小叶成一体，构架可以是弹性的，以使在压力作用下使得支柱在瓣膜关闭时倾斜(如接近0.05D)。

Claims (20)

1.一种心脏瓣膜假体，它包括一个构架和连接到该构架上的两个或多个小叶，其中，至少有一个小叶包括一个具有一球形表面的第一部分和一个具有一锥形表面的第二部分。
2.如权利要求1所述的假体，其特征在于，第一和第二部分的表面分别部分地是球形或锥形。
3.如权利要求1或2所述的假体，其特征在于，构架具有为圆形的横截面并带有在数目上与小叶的数目相同的两个或多个支柱，这些支柱从基体上沿相同方向延伸，以使由基体形成的瓣膜开口是敞开的。
4.如权利要求1或2所述的假体，其特征在于，小叶安装到支柱之间的构架上，并且每一小叶具有邻近支柱端部的自由边缘，这些自由边缘可在支柱端部密封在一起。
5.如权利要求1或2所述的假体，其特征在于，锥形部分位于邻近假体的基体，球形部分位于邻近自由边缘。
6.如权利要求1或2所述的假体，其特征在于，小叶是相同的。
7.如权利要求1或2所述的假体，其特征在于，假体包括3个小叶和3个支柱。
8.如权利要求1或2所述的假体，其特征在于，小叶是弹性的。
9.如权利要求1或2所述的假体，其特征在于，小叶具有一个在第一部分和第二部分之间的限定边缘。
10.如权利要求1或2所述的假体，其特征在于，通过采用一个与锥形部分配合的、半径逐步增大的球体来逐渐形成第一部分和第二部分之间的边缘，小叶的自由边缘或它的一部分具有为球形的表面。
11.如权利要求1或2所述的假体，其特征在于，小叶包括生物稳定材料，并且是浸渍模塑而成，从而使小叶与支撑构架和支柱结合。
12.如权利要求1或2所述的假体，其特征在于，小叶为100-200μm。
13.如权利要求1或2所述的假体，其特征在于，小叶可以改变厚度，以便包括厚壁区域和邻近的薄壁区域。
14.如权利要求1或2所述的假体，其特征在于，小叶表面是轴对称的，而该对称轴线垂直于瓣膜构架的轴线和血液流动的预定方向。
15.如权利要求1或2所述的假体，其特征在于，构架的直径为距离D，球体的半径是在D/2和D/2-2(mm)之间。
16.如权利要求1或2所述的假体，其特征在于，锥形部分是截头的，并具有一个30°到45°范围内的半角。
17.如权利要求1或2所述的假体，其特征在于，打开瓣膜所需要的压力由公式Et3/R来确定，这里的E是弹性模量、t是小叶的厚度、R是弯曲部分的半径。
18.如权利要求1或2所述的假体，其特征在于，假体包括被收集气体的逸出通道。
19.如权利要求1或2所述的假体，其特征在于，假体还包括一带有植入缝线并保护假体免受支柱损害的装置。
20.如权利要求11所述的假体，其特征在于，所述生物稳定材料是生物稳定聚氨酯CSIRO。
CNB988020084A 1997-01-24 1998-01-22 心脏瓣膜假体 Expired - Lifetime CN1147275C (zh)

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WO1998032400A1 (en) 1998-07-30
DE69827016T2 (de) 2005-11-17
US6171335B1 (en) 2001-01-09
AU725504B2 (en) 2000-10-12
JP4067128B2 (ja) 2008-03-26
CA2278575A1 (en) 1998-07-30
GB9701479D0 (en) 1997-03-12
AU5675298A (en) 1998-08-18
EP1006949B1 (en) 2004-10-13
PT1006949E (pt) 2005-02-28
DE69827016D1 (de) 2004-11-18
EP1006949A1 (en) 2000-06-14
CN1244107A (zh) 2000-02-09
ES2231956T3 (es) 2005-05-16

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