CN101801314A - 循环瓣膜、系统和方法 - Google Patents

循环瓣膜、系统和方法 Download PDF

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CN101801314A
CN101801314A CN200880107329.0A CN200880107329A CN101801314A CN 101801314 A CN101801314 A CN 101801314A CN 200880107329 A CN200880107329 A CN 200880107329A CN 101801314 A CN101801314 A CN 101801314A
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valve
stability
junction surface
frame unit
framework
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CN101801314B (zh
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J·M·蒂勒恩
J·P·希尔
M·L·延松
W·J·德拉斯勒
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Boston Science & Technology Ltd
Boston Scientific Scimed Inc
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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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    • 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
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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
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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    • 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
    • A61F2/2475—Venous 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
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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
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
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    • 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
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Abstract

用于脉管系统的装置、系统和方法。该装置包括具有瓣膜框架的循环瓣膜，在所述瓣膜框架中框架元件限定框架单元。框架单元包括成相对关系的接合部，其中当所述接合部朝向彼此被牵拉时所述接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态。

Description

循环瓣膜、系统和方法
技术领域
本公开一般涉及用于脉管系统中的装置、系统和方法；尤其涉及用于天然瓣膜置换和/或增大的装置、系统和方法。
背景技术
脉管系统的瓣膜会由于各种原因而受损和/或病变。例如，受损和/或病变心脏瓣膜根据涉及哪个瓣膜或哪些瓣膜和受损和/或病变瓣膜破坏的血流量被分组。最常见的心脏瓣膜疾病出现在二尖瓣和主动脉瓣中。三尖瓣和肺动脉瓣的疾病相当少见。
主动脉瓣调节从心脏的左心室进入主动脉的血流。主动脉是将含氧血液供应给身体的主要动脉。因此，主动脉瓣的疾病会对个体的健康产生显著影响。这样的疾病的例子包括主动脉反流和主动脉狭窄。
主动脉反流也被称为主动脉不足或主动脉不全。在该情况下血液从加宽或弱化的主动脉瓣回流到心脏的左心室中。在它的最严重形式中，主动脉反流由在瓣叶中留下孔的感染导致。主动脉反流的症状可能多年不出现。当症状不出现时，这是因为左心室相对于未受损主动脉瓣必须更努力工作以补偿血液的回流。心室最终变得更大并且流体后退。
主动脉狭窄是主动脉瓣的缩窄或阻塞。当主动脉的瓣叶被覆有沉淀物时出现主动脉狭窄。沉淀物改变瓣叶的形状并且减小通过瓣膜的血流。再次地，左心室相对于未受损主动脉瓣必须更努力工作以补偿减小的血流。随着时间，额外工作会弱化心肌。
附图说明
附图的特征未按比例。
图1示出了根据本公开的心脏瓣膜的一个例子。
图2示出了根据本公开的框架单元的一个例子。
图3示出了根据本公开的框架单元的接合部和柔性段的一个例子。
图4A示出了根据本公开的处于未展开状态的心脏瓣膜的一个例子。
图4B示出了根据本公开的处于展开状态的图4A的心脏瓣膜的一个例子。
图5示出了根据本公开的心脏瓣膜的一个例子。
图6示出了根据本公开的框架单元和锁定机构的一个例子。
图7示出了根据本公开的框架单元和展开机构的一个例子。
图8A和8B示出了包括根据本公开的心脏瓣膜的系统的一个实施例的横截面图。
图8C示出了用于包括根据本公开的心脏瓣膜的系统的一个实施例的球囊导管。
具体实施方式
本发明的实施例涉及用于天然瓣膜置换和/或增大的装置、系统和方法。例如，该装置可以包括用于置换体腔中的不完全天然瓣膜(例如主动脉瓣、二尖瓣、三尖瓣、肺动脉瓣和/或静脉瓣)的循环瓣膜。瓣膜的实施例包括具有框架元件的瓣膜框架，所述框架元件限定带有接合部的框架单元，当接合部朝向彼此被牵拉时，所述接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态。在一个例子中，本公开的实施例可以帮助增强或代替患有心脏和/或静脉瓣疾病的个体的天然瓣膜的功能。
本文的图遵循的编号原则是最先的一个数字或多个数字对应于图号并且其余的数字识别图中的元件或部件。不同图之间的类似元件或部件可以通过类似数字的使用进行识别。例如，110可以表示图1中的元件“10”，并且类似元件可以在图2中被表示为210。应当理解，本文的各个图中所示的元件可以被加入、交换和/或消除以提供瓣膜和/或系统的许多附加实施例。另外，应当理解图中提供的元件的比例和相对标度旨在示出本发明的实施例，而不应当被视为限制意义。
本公开的各种实施例在图中被示出。一般地，循环瓣膜可以被植入体腔的流体通道内，例如用于体腔内天然心脏瓣膜结构(例如主动脉瓣)的置换或增大以调节体液沿单向流过体腔。
本公开的循环瓣膜的实施例包括自膨胀到第一稳定平衡状态的瓣膜框架。瓣膜框架的第一稳定平衡状态是相对于循环瓣膜的展开状态的部分展开状态。在该部分展开状态下，循环瓣膜相对于预期植入部位的位置可以被调节以校正当自膨胀支架从小的压缩未展开状态膨胀时会在它们中出现的任何缩短和/或支架跳跃。另外，在完成展开之前使循环瓣膜处于部分展开状态由于从心室输出的血流推动展开系统所导致的运动而允许调节，当植入主动脉瓣时情况就是这样。
当在本文中使用时，瓣膜框架的部分展开状态处于未展开状态(即，当瓣膜在身体外部时瓣膜框架的状态)与展开状态(即，当瓣膜在身体中处于左边时瓣膜框架的状态)之间。循环瓣膜上的结构然后可以从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态以展开循环瓣膜。
在各种实施例中，将瓣膜框架保持在部分展开状态允许循环瓣膜在它的最后展开之前更好地定位在预期部位。本公开的循环瓣膜的该分阶段展开与展开时在中间展开阶段(即，部分展开状态)没有暂时停止的优点的循环瓣膜形成对比，从而在完全展开之前允许调节循环瓣膜的放置。
图1提供了本公开的循环瓣膜100的一个实施例。循环瓣膜100包括瓣膜框架102和联接到瓣膜框架102的瓣叶104。瓣膜框架102也包括限定框架单元108的框架元件106。框架单元108可以包括从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态的接合部110。在一个实施例中，当接合部110中的一个或多个朝向彼此被牵拉时可以出现该过渡，这将在本文中进行论述。
瓣膜框架102具有带近端112和远端114的细长管状结构。在一个实施例中，本公开的框架单元108可以被定位以提供瓣膜框架102的近端112和远端114。换句话说，框架单元108的一部分限定瓣膜框架102的近端112和远端114。在一个附加实施例中，本公开的框架单元108可以位于瓣膜框架102的近端112和远端114之间(即，框架单元108的一部分并不限定框架102的近端112和/或远端114)。在一个可选实施例中，本公开的框架单元108可以位于瓣膜框架102的近端112或远端114之一上。不同组合也是可能的。
对于各种实施例，接合部110可以位于框架元件106上的多个不同位置。例如，接合部110可以位于沿着框架元件106的相同相对位置上。因此，当框架单元108包括两个接合部110时，它们可以成镜像关系彼此相对地设置。本公开的该方面在图1中示出，图1显示了处于第一稳定平衡状态的循环瓣膜100。可选地，接合部110可以处于沿着框架元件106的不同相对位置，这将在本文中进行论述。
在一个附加实施例中，接合部110可以位于框架元件106上，使得当接合部110从第一稳定平衡状态过渡到第二稳定平衡状态时，瓣膜框架102的周长的尺寸(例如长度)增加。换句话说，接合部110以这样的方式位于框架元件106上，使得当接合部110朝向第二稳定平衡状态移动时导致瓣膜框架102在尺寸上径向增加。在一个实施例中，在接合部110过渡期间，当框架单元108改变形状时，瓣膜框架102增加它的周长尺寸。应当理解，当周长尺度改变时，瓣膜框架102的纵向尺度可以出现一些变化。
如上所述，图1提供了一种图示，其中瓣膜框架102的接合部110处于第一稳定平衡状态。在各种实施例中，第一稳定平衡状态使瓣膜框架102处于部分展开状态。当在本文中使用时，瓣膜框架的部分展开状态处于未展开状态(即，当瓣膜在身体外部时瓣膜框架的状态)与展开状态(即，当瓣膜在身体中处于左边时瓣膜框架的状态)之间。瓣膜框架102保持在部分展开状态，直到接合部110移动到如本文所述的第二稳定平衡状态。在一个实施例中，在第一稳定平衡状态下的瓣膜框架102是展开状态的百分之八十(80)到百分之九十五(95)。展开状态的其他百分比是可能的(例如展开状态的百分之九十(90))。
在各种实施例中，框架单元108可以包括一个或多个接合部110。如图1中所示，框架单元108包括两个接合部110。在一个附加实施例中，瓣膜框架102的每个框架单元108不需要具有接合部110。换句话说，框架单元108没有接合部110。因此，在一个实施例中，瓣膜框架102可以以这样的方式被配置，使得并不是每个框架单元108包括接合部110。
不具有接合部110的框架单元108可以被整合到瓣膜框架102中以为框架102提供有益于瓣膜100的操作的结构特性。例如，没有接合部110的框架单元108可以沿径向方向挠性更大以更好地适应植入部位的生理变化。这样的设计性质的例子包括但不限于提供弹性径向力，其中框架元件106可以具有至少部分提供弹性径向力的蛇形弯曲。框架单元108(具有或不具有接合部110)的其他形状和配置也是可能的。
对于各种实施例，瓣膜框架102可以自膨胀。自膨胀框架的例子包括由在指定温度或温度范围下改变形状的温度敏感记忆合金形成的那些。可选地，自膨胀框架可以包括具有弹簧偏压的那些框架。合适材料的例子包括但不限于医用级不锈钢(例如316L)、钛、钽、铂合金、铌合金、钴合金、藻酸盐或它们的组合。形状记忆材料的例子包括形状记忆塑料、聚合物和在体内不活泼的热塑材料。通常由一定比例的镍和钛制造的具有超弹性的形状记忆合金(通常被称为镍钛诺)也是可能的材料。其他材料也是可能的。
对于各种实施例，框架元件106沿着它的长度可以具有类似和/或不同的横截面几何形状。横截面几何形状的相似性和/或差异性可以基于从瓣膜框架102和/或框架单元108的每个部分引出的一个或多个预期功能。横截面几何形状的例子包括矩形、非平面配置、圆形(例如圆形、卵形和/或椭圆形)、多边形、弧形和管状。其他横截面几何形状是可能的。
循环瓣膜100还可以包括一个或多个不透射线标记(例如突片、套筒、焊缝)。例如，瓣膜框架102的一个或多个部分可以由不透射线材料形成。不透射线标记可以附连到和/或涂覆到沿着瓣膜框架102的一个或多个位置上。不透射线材料的例子包括但不限于金、钽和铂。一个或多个不透射线标记的位置可以被选择以在瓣膜100的植入期间提供关于它的位置、定位和取向的信息。
循环瓣膜100还包括具有表面的瓣叶104，所述表面限定用于液体单向流过瓣膜100的逆向可密封开口。例如，瓣叶104可以联接到瓣膜框架102以横跨和控制通过瓣膜100的内腔的流体流。对于本实施例，瓣膜100包括用于双叶配置的两个瓣叶104。应当理解，单叶、三叶和/或多叶配置也是可能的。每个瓣叶104联接到瓣膜框架102，其中瓣叶104可以在敞开状态和闭合状态之间重复地移动以用于液体单向流过循环瓣膜100的内腔。
在一个实施例中，瓣叶104可以从同源、异源或异种移植材料获得。应当理解，异种移植材料源(例如心脏瓣膜)包括但不限于哺乳动物源，例如猪、马和绵羊。由其形成瓣叶104的附加生物材料包括但不限于外植静脉、心包膜、阔筋膜、割除(harvested)心脏瓣膜、膀胱、静脉壁、各种胶原类型、弹性蛋白、肠粘膜下层和去细胞基膜材料，例如小肠粘膜下层(SIS)、羊膜组织或脐静脉。
可选地，瓣叶104可以由合成材料形成。可能的合成材料包括但不限于膨体聚四氟乙烯(ePTFE)、聚四氟乙烯(PTFE)、聚苯乙烯-聚异丁烯-聚苯乙烯(SIBS)、聚氨酯、嵌段聚(碳酸酯-氨基甲酸乙酯)、聚酯、聚乙烯(PE)、聚乙烯对苯二甲酸酯(PET)、蚕丝、氨基甲酸乙酯、人造纤维等。在一个附加实施例中，合成材料也可以包括金属，例如不锈钢(例如316L)和镍钛诺。这些合成材料可以是机织、针织、铸塑或其他已知的物理上的体液不可渗透或可渗透配置。另外，电镀金属(例如金、铂、铑)可以被嵌入瓣叶104材料(例如夹层配置)中以允许在放置后显示瓣叶104。
应当理解，瓣膜100可以被处理和/或涂覆有任何数量的表面或材料处理。这样的处理的例子包括但不限于生物活性剂，包括调节血栓形成的那些，促进细胞向内生长、贯穿生长和内皮化的那些，抵抗感染的那些，和减小钙化的那些。
对于各种实施例，框架单元108也包括在框架单元108的角部分118与接合部110之间延伸的柔性段116。当接合部110从第一稳定状态通过不稳定状态过渡到第二稳定状态时柔性段116可以从角部分118弹性挠曲或偏转。在其偏转状态下的柔性段116然后可以帮助将接合部110保持在第二稳定平衡状态。
在一个实施例中，接合部110和柔性段116的组合提供了双稳态柔性机构。用于框架单元108中的双稳态柔性机构包括在其运动范围内的两个稳定平衡状态。在本实施例中，这些是第一稳定平衡状态和第二稳定平衡状态，在它们之间具有不稳定平衡状态。用于本公开中的双稳态机构并不需要单元108的接合部110的功率输入以在每个平衡状态下保持稳定。稳定平衡的状态基本上是当不稳定平衡状态未实现时框架单元108的接合部110和柔性段116返回的相对势能最小值的位置。
图2提供了接合部210和柔性段216从第一稳定平衡状态222通过不稳定平衡状态224过渡到第二稳定平衡状态226的图示。在一个实施例中，当接合部210朝向彼此被牵拉时出现该过渡。示出该力可以如何被施加到接合部210和柔性段216的实施例将在本文中进行描述。
除了示出接合部210和柔性段216的过渡之外，图2也提供了根据势能232示出接合部210和柔性段216的平衡状态222和226的相对位置的图形230。如图形230中所示，接合部210和柔性段216的第一稳定平衡状态222和第二稳定平衡状态226位于局部势能最小值(等于或不等于)，不稳定平衡状态224处于两个状态222和226之间。图形230也示出了由于接合部210和柔性段216的弹性，它们的形状远离第一稳定平衡状态222的变化将不导致过渡到第二稳定平衡状态226，除非足够的力被施加以克服不稳定平衡状态224。
图2也示出了框架单元208的纵向长度228在第二稳定平衡状态226中与第一稳定平衡状态222相比怎样更大。如本文所述，框架单元208的纵向长度228的该变化有助于增加其中使用框架单元208的瓣膜的周长。
应当理解，单元208的接合部210和柔性段216的配置和设计可以改变第一稳定平衡状态222和第二稳定平衡状态226的相对值。例如，除了别的以外，诸如角部分218和/或柔性段216的曲率半径和弧长这样的设计方面可以影响第一稳定平衡状态222和第二稳定平衡状态226的相对值。另外，每个框架单元208上的接合部210的数量、位置和配置也可以影响第一稳定平衡状态222和第二稳定平衡状态226的相对值。不同部件(例如接合部210和柔性段216)的元件206的横截面形状和/或相对尺度的变化也可以影响第一稳定平衡状态222和第二稳定平衡状态226的相对值。
对于各种实施例，本公开的接合部可以具有多个不同配置。例如，图2中所示的接合部210具有环形配置，其中框架元件206自身弯曲以形成闭合曲线。在一个实施例中，框架元件206可以自身弯曲一次以上。
在一个可选实施例中，形成接合部的框架元件可以具有部分敞开的配置。图3提供了接合部310的这样的部分敞开配置的图示。如图所示，框架元件306包括延伸小于完整环的曲线334。
图4A和4B提供了根据本公开的瓣膜400的一个附加实施例。瓣膜400包括瓣膜框架402和联接到瓣膜框架402的瓣叶404。如本文所述，瓣膜框架402也包括限定具有接合部410的框架单元408的框架元件406。图4A提供了处于未展开状态的瓣膜400的图示，图4B提供了处于展开状态的瓣膜400的图示(例如其中接合部410处于它们的第二稳定平衡状态426)。如图所示，接合部410具有带曲线434的部分敞开配置。
图4A和4B中所示的接合部410也包括由瓣膜框架402限定的开口435。在一个实施例中，由瓣膜框架402限定的开口435可以用于将瓣膜框架402的接合部410从第一稳定平衡状态通过不稳定平衡状态推进到第二稳定平衡状态。在一个实施例中，当一个或多个接合部410朝向彼此被牵拉时出现该过渡，这将在本文中进行论述。
瓣膜框架402具有带近端412和远端414的细长管状结构。在一个实施例中，本公开的框架单元408可以被定位以提供瓣膜框架402的近端412和远端414。如本文所述，其他配置是可能的。
如图所示，接合部410位于框架元件406上，使得当接合部410过渡到第二稳定平衡状态时，瓣膜框架402的周长的尺寸(例如长度)增加。换句话说，接合部410以这样的方式位于框架元件406上，使得当接合部410朝向第二稳定平衡状态移动时导致瓣膜框架402在尺寸上径向增加。在一个实施例中，在接合部410过渡期间当框架单元408改变形状时，瓣膜框架402增加它的周长尺寸。应当理解，当周长尺度改变时，瓣膜框架402的纵向尺度可以出现一些变化。
对于各种实施例，如本文所述，瓣膜框架402可以自膨胀。对于各种实施例，如本文所述，框架元件406沿着它的长度可以具有类似和/或不同的横截面几何形状。如本文所述，循环瓣膜400还可以包括一个或多个不透射线标记(例如突片、套筒、焊缝)。
图5提供了根据本公开的瓣膜500的一个附加实施例。瓣膜500包括瓣膜框架502和联接到瓣膜框架502的瓣叶504。如本文所述，瓣膜框架502也包括框架元件506，所述框架元件限定具有接合部510的框架单元508。如图所示，尽管框架单元508位于瓣膜框架502的近端512和远端514，并不是每个框架单元508包括接合部510。另外，框架单元508中的接合部510具有沿着框架元件506的不同相对位置。
图5也示出了瓣膜框架502具有框架元件506，所述框架元件限定在框架单元508之间延伸的预定框架设计540。如图所示，预定框架设计540和框架单元508具有不同配置。预定框架设计540的选择可以基于许多因素。除了别的以外，这样的因素包括但不限于瓣膜500将被植入的部位，瓣膜500的尺寸，用于形成瓣膜500的瓣膜框架502的材料(一种或多种)。其他有用的框架设计的例子包括在名称为“Percutaneous Valve，System and Method(经皮瓣膜、系统和方法)”的共同未决的美国专利申请No.60/899,444(代理人档案号07-00015P)中示出的那些。
图6提供了本公开的一个附加实施例，其中框架单元608包括锁定机构644。在各种实施例中，锁定机构644可以接合以防止框架单元608从第二稳定平衡状态过渡。如图所示，本实施例的锁定机构644可以包括可以接合以锁定在一起的第一接合元件646和第二接合元件648。
在一个实施例中，当框架单元608从不稳定平衡状态624移动到第二稳定平衡状态626时，在框架单元608上的第一接合元件646和第二接合元件648接合以锁定在一起。如图所示，第一接合元件646从接合部610中的一个(例如第一接合部)延伸，而第二接合元件648从框架单元608的接合部610中的另一个(例如第二接合部)延伸。可选地，接合元件可以从框架单元608的柔性段616的一部分延伸。对于各种实施例，锁定机构644可以允许第二状态626不同于局部势能最小值，原因是它更好地保证框架单元608不返回到它的第一稳定平衡状态622。
用于框架单元608的锁定机构644可以采用许多不同形式和配置。例如，锁定机构644的第一接合元件646可以包括具有球端的杆。第二接合元件648可以具有凹窝以接收和锁定杆的球端。可选地，锁定机构644的第一接合元件646可以包括具有弯钩的杆。第二接合元件648可以具有环或元件段以接收和接合弯钩，从而锁定框架单元608。在一个实施例中，第二接合元件648的环可以是接合部610的环或框架元件606的一部分，其与弯钩相对并且在功能上与其对准。
图7提供了用于将接合部710从第一稳定平衡状态722通过不稳定平衡状态724过渡到第二稳定平衡状态726的展开机构750的图示。如图所示，展开机构750可以用于施加力以朝向彼此牵拉接合部710。当到达第二稳定平衡状态726时，展开机构750可以从框架单元708的接合部710被去除。
对于本实施例，展开机构750包括具有内腔754的推管752，和延伸通过内腔754的展开线756。推管752包括可以邻接第一接合部710的远端758。展开线756从内腔754延伸并且通过穿过第一接合部710定位的第二接合部710形成环。牵引力760可以通过展开线756被施加和/或推力762可以通过推管752被施加，从而施加力以朝向彼此牵拉接合部710。
当到达第二稳定平衡状态726时，可以通过拉动线756的第一端以允许线756的第二端穿过接合部710而从接合部710去除展开线756。线756和推管752然后可以从框架单元708被去除。从框架接合部710去除线756的其他方式也是可能的。
对于各种实施例，展开线756可以具有许多不同配置。例如，展开线756可以是单丝(即，单股材料)。可选地，展开线756可以具有多股配置。例如，具有多股的展开线756可以具有机织、针织和/或绞合配置。这些配置的组合也是可能的。
展开线756也可以具有多层构造，其中展开线756包括由一层或多层围绕的芯。展开线756的芯和层可以由不同材料和/或具有不同预期性质的相同材料形成。另外，展开线756还可以包括并不一定构成“层”的涂层(即，嵌入或整合到涂层所应用的层中的材料)。除了别的以外，这样的层和/或涂层可以赋予展开线756诸如硬度和/或润滑这样的性质。
展开线756可以由多种材料形成。这样的材料可以具有足够的拉伸强度和屈服点以抵抗拉伸，从而允许本公开的框架单元如本文所述被展开。这样的材料的例子包括但不限于聚合物，例如尼龙(一种或多种)、缩醛、Pebax、PEEK、PTFE、聚酰胺、聚吡咯(polypyrol)和Kevlar。可选地，展开线756可以由金属和/或金属合金形成，例如不锈钢、埃尔吉洛伊合金(elgioly)、镍钛诺和钛。其他聚合物、金属和/或金属合金也是可能的。线756也可以涂覆有润滑材料，例如亲水涂层。在如本文所述的一个或多个配置中，展开线756的材料也包括这些材料的组合。
推管752可以由许多不同材料形成。材料包括金属(一种或多种)、金属合金和聚合物，例如PVC、PE、POC、PET、聚酰胺、它们的混合物和嵌段共聚物。另外，如本文所述，推管752可以具有足以允许展开线756纵向滑动通过内腔754的壁厚和内腔直径和具有足以施加推力762的裂断强度。
图8A和8B示出了根据本公开的系统866的一个实施例的横截面图。系统866包括如本文所述的可释放地联接到细长输送导管868的循环瓣膜800。系统866也包括可缩回护套870，其中循环瓣膜800可释放地定位在护套870与输送导管868之间。例如，图8A示出了一个实施例，其中可缩回护套870围绕输送导管868的至少一部分定位以将瓣膜800可释放地保持在未展开状态。图8B示出了一个实施例，其中护套870相对于输送导管868缩回以允许瓣膜800膨胀到它的部分展开状态。
在该例子中，输送导管868包括具有近端874和远端876的细长主体872。内腔878延伸通过近端874和远端876。在一个实施例中，内腔878接收用于引导循环瓣膜800放置到脉管系统中的导丝。
对于各种实施例，细长输送导管868也包括远侧尖端880。对于各种实施例，远侧尖端880具有圆锥形配置，其中与尖端880的近侧部分相比，尖端880在输送导管868的远端876附近具有直径更小部分。远侧尖端880也可以包括凹唇边882，可缩回护套870的远侧部分可以可释放地位于其中。在一个实施例中，使可缩回护套870的远侧部分位于凹唇边882中有助于将瓣膜800保持在它的未展开状态。
可缩回护套870可以相对于输送导管868纵向移动(例如滑动)以允许循环瓣膜800从它的未展开状态朝向第一稳定平衡状态膨胀。在一个实施例中，相对于输送导管868移动可缩回护套870可以通过相对于输送导管868的近侧部分886拉动护套870的近侧部分884实现。
如本文所述，系统866也包括用于展开机构的推管852和展开线856。如图所示，推管852定位在护套870与输送导管868之间。推管852也包括近侧部分888，管852可以从所述近侧部分相对于护套870和输送导管868纵向地移动。在一个实施例中，如本文所述，近侧部分888允许用户通过管852将推力施加到接合部810。对于各种实施例，展开线856从推管852的内腔854延伸，其中展开线856和推管852的至少远端859可释放地接合框架单元808的接合部810。
如图8B中所示，如本文所述，在可缩回护套870相对于瓣膜800缩回之后，循环瓣膜800膨胀到它的第一稳定平衡状态。当瓣膜800处于它的第一稳定平衡状态时推管852被显示为弯曲。当展开线856通过框架单元808的第二接合部810形成环时，推管852也被显示为邻接第一接合部810。如本文所述，通过展开线856和/或推管852施加的力然后可以用于将瓣膜800从第一稳定平衡状态过渡到第二稳定平衡状态。
系统866的实施例还可以包括形成可缩回护套的一部分的可膨胀过滤器。这样的实施例的例子可以在名称为“Percutaneous Valve，System and Method(经皮瓣膜、系统和方法)”的共同未决美国专利申请No.___/___,___(代理人档案号07-00015US)中找到，上述申请全文被引用于此作为参考。
输送导管868、可缩回护套870中的每一个可以由许多材料形成。材料包括聚合物，诸如PVC、PE、POC、PET、聚酰胺、它们的混合物和嵌段共聚物。另外，输送导管868和可缩回护套870中的每一个可以具有足以如本文所述允许所述结构相对于彼此纵向滑动和如本文所述将循环瓣膜800保持在压缩状态的壁厚和内径。
如本文所述，在推管852与展开线856之间施加力以允许框架单元808过渡到第二稳定平衡状态(例如展开状态)。将框架单元808过渡到第二稳定平衡状态(例如展开状态)的附加方法也是可能的。例如，两个或以上展开线可以用于每个框架单元以将接合部牵拉到第二稳定平衡状态。可选地，框架单元可以在支架的近端邻接可缩回护套，而展开线可以用于将接合部牵拉到第二稳定平衡状态。其他配置也是可能的。
在一个附加实施例中，可以通过由球囊导管径向膨胀瓣膜800帮助瓣膜800在脉管系统内处于它的展开状态。例如，图8C提供了在推管和展开线从瓣膜框架802被去除之后瓣膜800的图示。具有可充气球囊894的球囊导管892可以定位在瓣膜800的内腔中。球囊894可以由充气设备896通过与球囊892流体连通的导管内腔898供应的流体进行充气。在一个实施例中，球囊894可以具有“狗骨”形状，其中球囊的球头端与瓣膜800的框架单元808对准。球囊892然后可以接触和径向膨胀瓣膜框架802以更好地保证瓣膜800被展开。
在一个附加实施例中，循环瓣膜800还可以包括定位在瓣膜框架802的周边上的密封材料801。在一个实施例中，一旦植入组织，密封材料801可以由于液体的存在而泡胀以占据瓣膜框架802与瓣膜800植入其上的组织之间的体积，从而防止循环瓣膜800外部周围液体的泄露。
适合于密封材料801的各种材料是可能的。例如，密封材料801可以选自包括多糖、蛋白质和生物相容凝胶的材料的一般类别。这些聚合材料的具体例子可以包括但不限于源自聚(氧化乙烯)(PEO)、聚乙烯对苯二甲酸酯(PET)、聚(乙二醇)(PEG)、聚(乙烯醇)(PVA)、聚(乙烯吡咯烷酮)(PVP)、聚(乙基噁唑啉)(PEOX)、聚胺酸、假聚胺酸和聚乙基噁唑啉的那些，以及这些彼此之间或与其他水溶性聚合物或水不溶性聚合物的共聚物。多糖的例子包括源自藻酸盐、透明质酸、硫酸软骨素、右旋糖酐、硫酸右旋糖酐、肝素、硫酸肝素、硫酸乙酰肝素、脱乙酰壳多糖、结冷胶、黄胞胶、瓜尔胶、水溶性纤维素衍生物和角叉菜聚糖的那些。蛋白质的例子包括源自明胶、胶原、弹性蛋白、玉米蛋白和白蛋白的那些，无论从自然还是重组源产生。
本文所述的瓣膜的实施例可以用于置换、补充或增大身体的一个或多个内腔内的瓣膜结构。例如，本发明的实施例可以用于置换心脏的不完全心脏瓣膜，例如心脏的主动脉、肺动脉和/或二尖瓣。在一个实施例中，在植入本公开的循环瓣膜之前，天然心脏瓣膜可以保留在原位(例如通过瓣膜成形程序)或被去除。
另外，定位具有如本文所述的瓣膜的系统包括使用微创经皮、经腔技术将系统引入患者的心血管系统中。例如，导丝可以被定位在包括预定位置的患者的心血管系统内。包括如本文所述的瓣膜的本公开的系统可以定位在导丝上并且系统被推进以将瓣膜定位在预定位置处或附近。在一个实施例中，如本文所述，导管和/或瓣膜上的不透射线标记可以用于帮助定位和放置瓣膜。
如本文所述，瓣膜可以在预定位置以多种方式从系统被展开。在一个实施例中，本公开的瓣膜可以在多个心血管位置被展开和放置。例如，瓣膜可以被展开和放置在患者的主要动脉内。在一个实施例中，主要动脉包括但不限于主动脉。另外，本发明的瓣膜可以被展开和放置在心脏的其他主要动脉内和/或心脏自身内，例如在肺动脉中以用于置换和/或增大肺动脉瓣和在左心房与左心室之间以用于置换和/或增大二尖瓣。循环瓣膜也可以被植入腿静脉(例如髂静脉、股静脉、大隐静脉、腘静脉和浅隐静脉)中。其他位置也是可能的。
如本文所述，循环瓣膜可以以分阶段方式被展开。在第一阶段中，瓣膜由可缩回护套保持在它的未展开状态(例如压缩状态)。可缩回护套然后可以移动(例如缩回护套)以允许瓣膜从未展开状态径向膨胀到第一稳定平衡状态。如本文所述，瓣膜框架的接合部然后可以从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态以展开循环瓣膜。在一个附加实施例中，循环瓣膜也可以由可充气球囊径向膨胀以将循环瓣膜设置为展开状态。
一旦被植入，瓣膜可以提供与身体腔壁的充分接触以防止瓣膜与身体腔壁之间的反流，并且牢固地定位瓣膜和防止瓣膜的迁移。本文所述的瓣膜也显示充分的挠性和弹性以适应体腔直径的变化，同时保持瓣膜的适当放置。如本文所述，瓣膜可以接合内腔以减小通过和围绕瓣膜的反流的体积。然而，应当理解在瓣膜与体腔之间和/或通过瓣叶可能出现一定的泄露或流体流。
尽管以上详细显示和描述了本发明，本领域的技术人员将显而易见可以在不脱离本发明的精神和范围的情况下进行变化和修改。例如，本文所示的牵引机构可以用于机械地膨胀其他类型的自膨胀支架的一个瓣膜框架和/或多个瓣膜框架以将横截面尺寸(例如直径)扩大到它的最完全尺度。照这样，在前面的描述和附图中阐述的内容仅仅通过举例说明而不是作为限制被提供。本发明的实际范围旨在由以下权利要求以及这样的权利要求享有的等效物的完整范围限定。另外，当阅读和理解该公开时本领域的普通技术人员应当理解本文所述的本发明的其他变型可以包括在本发明的范围内。
在前面的具体实施方式中，为了精简公开内容的目的将各种特征在几个实施例中分组在一起。该公开方法不应当被理解为反映本发明的实施例需要比每个权利要求中明确引用的更多的特征的意图。相反地，如以下权利要求所反映的，本发明的主旨在于少于单一公开实施例的所有特征。因此，以下权利要求在此被包含到具体实施方式中，每个权利要求坚持作为单独实施例。

Claims (21)

1.一种循环瓣膜，包括：
具有框架元件的瓣膜框架，所述框架元件限定带有成相对关系的接合部的框架单元，其中当所述接合部朝向彼此被牵拉时所述接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态；和
联接到所述瓣膜框架的瓣叶。
2.如权利要求1所述的循环瓣膜，其中第一稳定平衡状态和第二稳定平衡状态是当不稳定平衡状态未实现时所述框架单元的接合部返回的相对势能最小值的位置。
3.如前述权利要求中任一项所述的循环瓣膜，其中所述框架元件包括帮助将所述接合部保持在第二稳定平衡状态的柔性段。
4.如前述权利要求中任一项所述的循环瓣膜，其中所述框架单元被定位在所述瓣膜框架的远端和近端中的至少一处。
5.如前述权利要求中任一项所述的循环瓣膜，其中所述框架元件限定在所述框架单元之间延伸的预定框架设计，其中所述预定框架设计和所述框架单元具有不同配置。
6.如前述权利要求中任一项所述的循环瓣膜，其中所述框架单元包括锁定机构，所述锁定机构接合以防止所述框架单元从第二稳定平衡状态过渡。
7.如权利要求6所述的循环瓣膜，其中所述锁定机构包括第一接合元件，当所述接合部从不稳定平衡状态过渡到第二稳定平衡状态时第一接合元件从第一接合部延伸以接合从所述框架单元的第二接合部延伸的第二接合元件。
8.如前述权利要求中任一项所述的循环瓣膜，其中第一稳定平衡状态是展开状态的百分之八十(80)到九十五(95)。
9.一种分阶段展开循环瓣膜的方法，包括：
将所述循环瓣膜的瓣膜框架从未展开状态径向膨胀到第一稳定平衡状态；和
将所述瓣膜框架的接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态以展开所述循环瓣膜。
10.如权利要求9所述的方法，其中从未展开状态径向膨胀所述瓣膜框架包括从未展开状态释放所述循环瓣膜。
11.如权利要求9-10中任一项所述的方法，其中将所述接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态包括朝向彼此牵拉每个框架单元中的接合部。
12.如权利要求11所述的方法，其中在经过不稳定平衡状态之前停止每个框架单元中的接合部的移动导致所述接合部朝向第一稳定平衡状态返回。
13.如权利要求9-12中任一项所述的方法，其中过渡所述瓣膜框架的接合部包括将所述接合部通过不稳定平衡状态牵引到第二稳定平衡状态。
14.如权利要求9-13中任一项所述的方法，包括在第二稳定平衡状态下用锁定机构锁定所述瓣膜框架。
15.如权利要求9-14中任一项所述的方法，包括当所述瓣膜框架的接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态时挠曲所述瓣膜框架的柔性段以帮助将所述循环瓣膜保持在展开状态。
16.如权利要求9-15中任一项所述的方法，其中过渡所述接合部包括将所述接合部从第一稳定平衡状态通过不稳定平衡状态弹性变形到第二稳定平衡状态以展开所述循环瓣膜。
17.如权利要求9-16中任一项所述的方法，其中径向膨胀所述瓣膜框架包括膨胀所述瓣膜框架以使第一稳定平衡状态是第二稳定平衡状态的百分之八十(80)到九十五(95)。
18.一种系统，包括：
细长输送导管；
围绕所述细长输送导管的至少一部分定位的可缩回护套，其中所述可缩回护套相对于所述细长输送导管纵向地移动；
定位在所述细长输送导管与所述可缩回护套之间的循环瓣膜，其中所述循环瓣膜包括具有框架元件的瓣膜框架，和联接到所述瓣膜框架的瓣叶，所述框架元件限定带有成相对关系的接合部的框架单元；和
在所述细长输送导管与所述可缩回护套之间纵向延伸到所述框架单元的接合部的展开线，其中通过所述展开线施加的力将所述接合部从第一稳定平衡状态通过不稳定平衡状态过渡到第二稳定平衡状态。
19.如权利要求18所述的系统，其中所述可缩回护套相对于所述细长输送导管纵向地移动以允许所述循环瓣膜从未展开状态移动到第一稳定平衡状态。
20.如权利要求18-19中任一项所述的系统，其中第一稳定平衡状态是第二稳定平衡状态的百分之八十(80)到九十五(95)。
21.如权利要求18-20中任一项所述的系统，包括在所述细长输送导管与所述可缩回护套之间纵向延伸以邻接所述接合部中的至少一个的推管，并且其中所述展开线通过所述推管延伸到所述框架单元的接合部以允许力被施加到所述展开线与所述推管之间的接合部。
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US20090030512A1 (en) 2009-01-29
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US20140379068A1 (en) 2014-12-25
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ATE523165T1 (de) 2011-09-15
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ES2371516T3 (es) 2012-01-04
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