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CN102497836A - 支架化假体心瓣膜 - Google Patents

支架化假体心瓣膜 Download PDF

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CN102497836A
CN102497836A CN2010800251480A CN201080025148A CN102497836A CN 102497836 A CN102497836 A CN 102497836A CN 2010800251480 A CN2010800251480 A CN 2010800251480A CN 201080025148 A CN201080025148 A CN 201080025148A CN 102497836 A CN102497836 A CN 102497836A
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valve
support
stent structure
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CN102497836B (zh
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B·J·米维
M·J·卡普斯
J·L·莎伊
D·A·泰塔克
M·多兰
C·E·艾伯哈德特
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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
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/28—Bones
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. 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
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2230/00—Geometry 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

一种经由皮肤植入而将外科无缝线的瓣膜(40)附连至支架框架(50)以递送至患者体内的合适部位中的装置和方法。

Description

支架化假体心瓣膜
技术领域
本发明涉及假体心瓣膜。具体来说，本发明涉及外科无缝线的瓣膜以及结合支架结构经由皮肤植入该假体心瓣膜的方法。
背景技术
患者的或其它形式缺陷的心瓣膜可采用各种不同类型的心瓣膜外科手术来修复或更换。典型的心瓣膜外科手术包括开心外科手术，其在全身麻醉下实施，在手术过程中，心脏要停止跳动，而血流由心肺旁路机来控制。这种类型的瓣膜外科术入侵创伤很大，并使患者面临许多潜在严重的风险，例如，感染、中风、肾坏死，以及与心肺机的使用有关的不利影响。
近年来，最小创伤且经由皮肤更换的心瓣膜越来越受到关注。这种外科技术包括在患者的皮肤上切开一个很小的开口，瓣膜组件进入该开口插入其体内，并通过类似于导管的递送装置递送到心脏。对于某些应用来说，该技术优于更加入侵形式的外科手术，例如，上述的开心外科手术。关于肺动脉瓣膜更换而言，授予Tower等人的美国专利申请公开号2003/0199971A1和2003/0199963A1均揭示了牛颈静脉的瓣膜部分，其安装在可膨胀支架内，用于肺动脉瓣膜的更换。更换的瓣膜安装在气囊导管上，并通过脉管系统经由皮肤的方式递送到病患的肺动脉瓣膜部位，用气囊来膨胀而压缩瓣膜小叶抵靠在右心室流出道上，锚固并密封该更换的瓣膜。如下述文章中所描述的：“肺动脉瓣膜的经由皮肤的插入方法”，Bonhoeffer等人，美国心脏病学学会杂志2002；39：1664-1669，以及“肺动脉位置中牛瓣膜的经导管方式的更换”，Bonhoeffer等人，2000发行；102：813-816，可植入更换的肺动脉瓣膜，用以替换天生的肺动脉瓣膜或位于瓣膜导管内的假体肺动脉瓣膜。
各种类型和构造的假体心瓣膜可用于经由皮肤方式的瓣膜手术中，以更换患者的天生人的心瓣膜。任何特殊的假体心瓣膜的实际形状和构造在某种程度上取决于所要更换的瓣膜(即，二尖瓣、三尖瓣、大动脉瓣或肺动脉瓣)。一般来说，假体心瓣膜的设计都试图复制所要更换的瓣膜的功能，因而将包括用于生物假体或机械假体的心瓣膜的瓣膜小叶状结构。换句话说，更换的瓣膜可包括以某种方式安装在可膨胀支架内而形成支架化瓣膜的瓣膜静脉部分。为了经由皮肤植入而准备这样的瓣膜，支架化瓣膜最初可设置在膨胀的或未卷曲的状态中，然后围绕导管的气囊部分卷曲或压缩，直到它尽可能接近于导管的直径为止。
还提出了其它的经由皮肤递送的假体心瓣膜：具有大致类似于如下文中所述的结构，例如，“肺动脉位置中牛瓣膜的经导管方式的更换”，Bonhoeffer等人，2000发行；102：813-816，以及“用于钙化大动脉狭窄的大动脉瓣膜假体的经由导管的植入方法”，Cribier，A.等人，2002发行；106：3006-3008，本文以参考方式援引它们的内容。这些技术至少部分地依赖于膨胀的支承结构和天生组织之间的摩擦型接合，以维持所递送的假体的位置，但支架也可响应于支架和某些时候用于使支架膨胀的气囊所提供的径向力变得至少部分地嵌入在周围组织中。因此，利用这些经由导管的技术，将假体心瓣膜缝合到患者天生的组织上的传统做法就不再必要了。类似地，在由Bonhoeffer，P.等人所著的题为“肺动脉瓣膜的经由皮肤的插入方法”文章中(J Am Coll Cardiol，2002；39：1664-1669)，描述了生物瓣膜经由皮肤的递送方法，本文以参靠方式援引其内容。瓣膜被缝合到先前植入的瓣膜或非瓣膜导管或先前植入的瓣膜内的可膨胀的支架上。再者，第二瓣膜支架的径向膨胀用于放置和保持更换的瓣膜。
尽管经由皮肤的瓣膜更换技术和装置已经取得了较大进步，但仍继续需要提供可以最小创伤方式和/或经由皮肤方式植入心瓣膜的各种不同的设计。
发明内容
某些诸如大动脉根生物假体之类的外科植入假体心瓣膜可从市场上以商标名为“Freestyle(自由式)”购得，其由明尼苏达州明尼阿玻利斯市的Medtronic公司出品，已经证明该假体心瓣膜具有优于大动脉瓣膜更换中所使用的其它生物假体的某些优点。然而，这些“Freestyle”型瓣膜的植入局限于那些在同种移植物的外科植入中成为专业熟练的外科医生。提供本发明更换的心瓣膜能克服这种局限性，并致力于不用缝合线将外科心瓣膜附连到患者身上。这样，可实现某种外科瓣膜的优点，而没有外科瓣膜植入手术中的缺点。即，本发明提供了诸如大动脉根生物假体之类的无缝线植入的外科瓣膜，大动脉根生物假体通常使用更为传统的外科技术植入患者体内。本发明假体心瓣膜包括可压缩到相对小直径的瓣膜，以经由皮肤递送到患者心脏，然后通过除去外部压缩力(例如，自膨胀支架)，或通过施加向外的径向力(例如，气囊可膨胀支架)而膨胀。
本发明更换的心瓣膜包括附连有瓣膜结构的支架。本发明支架包括各种结构和特征，它们可单独使用或与本发明其它支架的特征结合使用，并有助于经由皮肤对其递送。
插入本发明更换的心瓣膜的方法包括递送系统，该系统可在瓣膜的插入过程中使支架结构保持在压缩状态中，并允许或致使支架结构一旦位于其要求的位置后膨胀。该方法可包括使用前级或后级方法来植入支架结构。
本发明支架的一个实施例包括管状丝件结构，其包括大致沿支架的纵向轴线方向延伸的多个丝件。生物假体可附连到该支架的某些预定部位的金属丝上，并较佳地缝合到丝件上，使得制造生物假体的材料在支架和附连的生物假体的压缩和/或膨胀过程中不会损坏。在一个实施例中，支架包括三个连合附连区域，这些区域中的每个区域用于生物假体诸连合延伸部分的其中之一的连接部位。
本发明的支架瓣膜可使用外部管状材料，诸如牛颈静脉、心包组织、PTFE假体材料、聚酯布及其它材料，以便于小叶附连到支架或管状材料上。然后，可使用不同于使用小叶与支架结构直接附连的各种附连选项。这样，因为施加在小叶附连部位上的力从刚性支架结构传递到柔性的管状结构上，所以支架不会像瓣膜小叶那样经受长期的疲劳。
附图说明
本发明将参照附图作进一步解释，其中，在全部的若干个图中，相同的结构用相同的附图标记表示，且其中：
图1是现有技术的大动脉根生物假体的立体图；
图2是图1所示生物假体的前视图；
图3是图2所示生物假体的剖视图；
图4是现有技术的大动脉根生物假体的另一实施例的前视图；
图5是图4所示生物假体的剖视图；
图6是现有技术的大动脉根生物假体的另一实施例的前视图；
图7是图6所示生物假体的剖视图；
图8和9分别是根据本发明附连到支架的生物假体另一实施例的前视图和立体图；
图10是带有外部管状材料层的支架化瓣膜侧视图；
图11是图10所示支架化瓣膜的立体端视图；
图12是具有组织覆盖的膨胀的支架的另一立体图；
图13是定位在心轴上的示范支架框架的前视图；
图14是支架化瓣膜的一实施例的俯视立体图；
图15是图14所示支架化瓣膜的侧视图；
图16是相对于支架和附连的生物假体定位的递送系统的一部分的侧视图，其中，支架处于局部压缩状态中；
图17是图16所示递送系统和支架的生物假体的侧视图，其中，支架处于局部膨胀状态中；
图18是定位在心轴上的示范支架框架的前视图；
图19是可用于根据本发明瓣膜的另一示范支架框架的前视图。
具体实施方式
如本文所提及的，本发明各种心瓣膜递送装置和方法所用的假体心瓣膜可包括各种不同的构造，诸如具有组织小叶的假体心瓣膜，或具有聚合物、金属或组织设计(tissue-engineered)的小叶的人造心瓣膜，并可为更换任何心瓣膜进行特殊地构造。即，尽管这里描述的大部分是指大动脉瓣膜的更换，但本发明的假体心瓣膜还可通常用于天然二尖瓣、肺动脉瓣或三尖瓣的更换，以用作为静脉瓣膜，或替换诸如大动脉瓣膜或二尖瓣区域内的失效的生物假体。
一般而言，这里所述的支架包括支承结构，其包括多个支承条或丝件部分，它们相对于彼此布置以提供理想的可压缩性、强度和通向心瓣膜的小叶附连区域。本发明支架的特殊构造上的其它细节还将在下面进行描述；然而，通常来讲，本发明支架通常是管状支承结构，而生物假体可固定在管状支承结构的内部区域内以提供瓣膜支架。
更一般地讲，支承结构与生物假体的一个或多个小叶组合可呈现各种不同于以上所述和所示的其它结构，包括任何已知的假体心瓣膜设计。在本发明的某些实施例中，不管是可气囊膨胀的、自膨胀的，还是可展开的，带有小叶的支承结构采用已知可膨胀的假体心瓣膜结构的某些特征(例如，如上所述，美国专利号3,671,979；4,056,854；4,994,077；5,332,402；5,370,685；5,397,531；5,554,185；5,855,601；以及6,168,614；美国专利申请公开号2004/0034411；Bonhoeffer P.等人的“肺动脉瓣膜的经由皮肤的插入”，小儿心脏病学，2002；39：1664-1669；Anderson H R等人的“人工心瓣膜的经内腔移植”，EUR HeartJ.，1992；13：704-708；Anderson J.R.等人的“新型可膨胀人工心瓣膜的经内腔导管的移植”，EUR Heart J.，1990，11：(Suppl)224a；Hilbert S.L.的“移植的聚亚安酯三小叶心瓣膜假体的评估”，J Thorac Cardiovascular Surgery，1989；94：419-29；Block P C的“老年人经由皮肤的大动脉瓣膜成形术后的临床和血液动力学跟踪”，美国心脏病学杂志，62卷，1998年10月1日；Boudjemline，Y.的“经由皮肤的大动脉瓣膜更换的步骤”，2002发行；105：775-558；Bonhoeffer P.的“肺动脉位置中的牛瓣膜的经由导管的植入、羔羊研究”，2002发行：102：812-816；Boudjemline，Y.的“羔羊中降主动脉中的瓣膜的经由皮肤的植入”，EUR Heart J.，2002，23：1045-1049；Kulkinski，D.的“外科主动脉瓣膜更换术的前景：经由内腔的植入技术早期研究阶段中学到的教训”，ASAIO J，2004；50：364-68；本文以参靠方式援引所有这些介绍的内容)。
本发明瓣膜在患者体内的定向和定位可通过以下方法来实现：支架的自定向(诸如支架的部件和先前植入的支架或瓣膜结构的部件之间的干涉)，或手工定向支架，以使其部件与解剖学特征或先前植入的生物假体结构的部件对齐，诸如可用荧光镜目视技术来实现。例如，当本发明支架与天生的解剖学结构对齐时，它们应当被对齐成不阻塞冠状动脉，且天生的二尖瓣或三尖瓣应当相对于前小叶和/或三角形体瓣膜/连合体对齐，以允许这些结构正常发挥功能。
这里所述的支架的支承结构的某些实施例可包括一系列丝件或丝段，它们被布置成能够从折叠状态过渡到膨胀状态。在某些实施例中，许多包括支承结构的单独的丝件可由金属或其它材料制成。这些丝件被布置成允许支承结构折叠或压缩成收缩状态，在收缩状态中，其内径比其膨胀状态时的内径要大大地减小。在折叠状态时，该支承结构与附连的瓣膜或小叶可安装在递送装置上，例如，气囊导管。支承结构被构造成可在需要时变化到其膨胀状态，例如，通过气囊导管的膨胀。用于该支架的递送系统应当设有转动定向和轴向定向的度数装置，以便将支架适当地定位在患者体内的理想部位处。
其它实施例中支架的支承结构的丝件可替代地由诸如镍钛合金(例如，镍钛诺)的形状记忆材料制成。采用这种材料，支承结构可从收缩状态膨胀到膨胀状态，诸如通过施加热量、能量等方法或除去外力(例如压缩力)的方式来实现。该支承结构还可反复地压缩和再膨胀，而不会损坏支架的结构。此外，该实施例的支承结构可用激光从单块材料中切割出来，或可用多个不同的部件组装而成。对于这些类型的支架结构，可采用的递送系统的一个实例包括带有可收缩护套的导管，该护套覆盖支架，直到支架展开为止，此时护套可缩回而使支架膨胀。
现参照附图，其中，在全部的若干附图中，部件由同样的附图标记标示，首先参照图1-7，图中示出了无支架生物假体的多个变型。具体地，图1示出了大动脉根生物假体10，例如市场上由Medtronic公司出品的“自由式生物假体(Freestyle Bioprosthesis)”。该生物假体10和其它此类型的生物假体通常被称为无支架生物假体，它们被设计成模仿人体生理学，形成生理流动并真切地仿效天生大动脉瓣膜的性能。如图所示，生物假体10具有外部管状形状，该形状在用来覆盖所有暴露的猪心肌的一端处的管边缘上具有覆盖材料。该覆盖材料可由例如聚酯制成。生物假体10和本文所述的其它生物假体包括一个或多个定位在其内部管状区域内的可移动的小叶。在许多实施例中，生物假体具有两个或三个小叶，然而，它也可能仅设置一个小叶，和/或生物假体具有三个以上的小叶。图2和3分别是生物假体10的前视图和剖视图。生物假体10包括外管状部分14，其带有从其延伸出的多个小叶12的内壁。生物假体10使用在用于更换患者整个天生大动脉根和瓣膜的外科手术中。
图4和5分别是无支架生物假体20的另一替代结构的前视图和剖视图，其中，应该理解到，不同患者的需求和外科医生的偏好可以是影响为特殊患者选择最合适生物假体的因素。生物假体20包括外管状部分24，其带有从其延伸出多个小叶22的内壁。生物假体20可被称为“前置自由式完整副冠状生物假体(Prestyled Freestyle Complete Subcoronary Bioprosthesis)”，并设有用于非冠状窦、右冠状窦和左冠状窦的扇贝部分。
图6和7分别是无支架生物假体30的另一替代结构的前视图和剖视图，其被称之为“前置自由式改良副冠状生物假体(Prestyled Freestyle ModifiedSubcoronary Bioprosthesis)”。生物假体30包括外管状部分34，其带有从其延伸出多个小叶32的内壁。该生物假体30包括仅用于右和左冠状窦的扇贝部分。通常采用标准外科技术植入的任何这些生物假体，都可用于这里所述的技术和系统内，用于植入而无需使用缝线。
图8和9分别是定位在支架框架50内的无支架生物假体40的前视图和立体图。生物假体40包括流入端42、流出端43、三个连合延伸部44和介于成对延伸部44之间的扇贝部分形或扇贝形区域46。生物假体40还包括诸如聚酯布之类的材料48，其覆盖生物假体流入端42的至少一部分。如图所示，该材料48定位在生物假体40的外表面和组成支架50的丝件的内表面之间。然后，材料48延伸在生物假体40边缘或端部上，并延伸到内管状表面中材料48可沿着该内管状表面的壁的理想距离延伸。支架50包括一系列布置成大致管状的丝件，具体来说，包括围绕流入端42处的外围延伸的多个菱形结构52。支架50还包括多个U形或V形结构54，它们沿着支架50的长度纵向延伸。结构54分别具有大致从结构52的峰延伸的端部。相邻结构54可通过附加支承丝件56彼此连接在其相应的峰或峰附近处。
根据本发明，各个连合延伸部44用缝合线附连到V形结构54，缝合线彼此间隔开，并沿着每个结构54的两侧和峰延伸。可使用标准缝线材料来进行缝合，该缝线材料例如具有可终止在每个结构54的一端处的第一端和可终止在同一结构54的另一端处的第二端。或者，可使用不同的缝合型式。如图所示，通过将覆盖材料48和/或管状材料以锯齿形型式缝合到菱形结构52上，生物假体40可另外在其流入端42处固定到支架框架50上。尽管这些图仅显示了沿着各结构52的下部或边缘的缝合，但流入端42另外还可沿着结构52的上部或边缘缝合进行固定。然而，在某些应用中，图8和9所示的缝合型式可足以对瓣膜环面提供支承。
图10和11分别是另一支架化瓣膜60的侧视图和立体图，其可为其支架使用相同或不同的结构作为如上参照图8和9所讨论的支架框架50。或者，可使用不同的支架结构。在任何情形中，支架化瓣膜60包括被管状材料62包围的支架框架(图未示)，该管状材料可包括例如牛颈静脉。即，管状材料62定位在支架框架的外侧上。在这种情形中，猪小叶可定位在管状材料62的内部区域内。通过沿着支架框架的菱形结构的下部缝合和/或在其它部位处将部件彼此缝合起来，管状材料62可附连到支架框架上。不是使用小叶(诸如猪小叶)直接附连到支架，管状材料与支架的这种附连可转移长期的结构疲劳，因为从猪小叶到管/支架结构的加载条件是生理脉动的。
图12示出了可膨胀支架化瓣膜70的另一实施例，它包括用牛颈静脉组织覆盖的支架。猪组织附连在静脉组织内以保护小叶避免与丝件的支架框架直接接触。如图所示，组织通过沿着支架框架的部分进行缝合而附连到支架。可交替使用不同的缝合结构。
图13示出了另一示范的可附连无支架生物假体的支架框架100，诸如图1-7中所示的任意的生物假体。支架如图所示位于心轴上，以使前部丝件可更清楚地被看到。支架100可由诸如镍钛诺之类的自膨胀材料制成，或者可被构造成在由膨胀气囊提供的力的作用下膨胀。该支架100的尺寸可以足够短，以便它可被称为副冠状支架(例如，25mm长)，从而能够将支架放置在大动脉内的冠状动脉下方。
在一个实施例中，支架100大致呈管状形状，并包括多个纵向或垂直的丝件102，它们大致平行于支架的纵向轴线104延伸。丝件102围绕支架100的大致管状形状的外围彼此间隔开。支架100还包括可让组织附连而使支架进入瓣膜内的部件，诸如连合附连柱106。连合附连柱106可各自包括两个纵向丝件，它们彼此间距比丝件102彼此之间的间距更靠近。
在该实施例中，支架100包括三个连合附连柱106，其中，每个附连柱106可用作为生物假体的连合延伸部的其中之一的连接部位，例如，生物假体40的延伸部44。或者，多于或少于三个的附连柱106可分别提供给具有多于或少于三个小叶的瓣膜。除了提供用于连合附连的结构之外，附连柱106还为支架100提供附加的稳定性。支架100还包括多个V形丝件结构108，它们位于成对丝件102之间和/或丝件102和相邻的附连柱106之间。虽然支架100如图所示具有位于相邻垂直丝件结构之间的沿纵向彼此间隔开的V形丝件108中的三个，但也可以具有多于或少于三个V形丝件。所有的丝件108或其中部分丝件108可相对于支架100的外管状形状至少略向外张开，由此形成一体的突缘结构，其可用来在支架植入患者体内时捕捉天生的小叶。
附加的丝件结构122定位在支架100的端部120处，它们大致呈V形，每个“V”形结构的峰定向成大致与丝件108的峰相同的方向。所有的丝件结构122或其中部分的丝件结构122还相对于支架100的外管状形状至少略向外张开。为了捕捉患者天生解剖学特征，可选择各种丝件结构相对于支架的外管状形状的延伸量和角度。此外，丝件结构122的张开可有助于防止或最大程度地减小植入物和天然环面之间的泄漏，和/或提供实际和/或可见的对接(docking)特征，以便抵靠在心脏内开口的壁上固定该支架100，从而例如防止支架移动。
所有的丝件102和柱106或其中部分的丝件102和柱106的一端还可包括环圈或孔眼126，其可例如用于附连到递送系统和/或组织瓣膜。例如，单侧的孔眼附连端可用于前级和后级工序的可再被套上护套的递送系统中。
该实施例的支架包括空间或开口110，采用构成连合附连柱106的两个丝件之间的水平构件112来形成该空间或开口。这些开口110提供可让缝合材料、针和/或其它固定材料通过而插入的部位，以便将生物假体附连到支架框架。此外，水平构件112可用作为紧固材料的限定的锚固点。例如，缝合材料可通过第一开口110插入，然后，通过另一开口110以预定型式将瓣膜材料缝合到生物假体的连合延伸部。水平构件112还可用作锚固结构，其限制缝线或其它附连机构的垂直运动。为了将生物假体的其它区域附连到支架100，可将诸如以上相对于生物假体40所述的扇贝形区域沿着选定的支架100的丝件缝合，例如，沿着某种形状的丝件108和/或垂直的丝件102缝合。
下面描述将瓣膜材料(例如，组织小叶)附连在支架结构的内部区域内的多种系统、部件和装置。应当理解的是，这里为此目的所示和描述的各种系统可用于上述的支架构造和/或其它的支架构造。
图18示出了另一示范的可供无支架生物假体附连的支架框架130，诸如图1-7所示的任意的生物假体。该支架框架130如图所示位于心轴上，以使前丝件可更加清楚地被看到。支架130的尺寸可以被做成足够高或足够长，从而其可被称为前冠状支架，它可被放置成在大动脉中冠状动脉上方延伸。支架130包括至少一个纵向柱132，其大致沿着支架130的环形区域延伸，并具有可容纳附连的小叶材料的高度。利用该支架130，丝件结构延伸在柱132的一端和支架第一端134(其可被称为支架的大动脉方面)之间，而附加的丝件结构延伸在柱132的另一端和支架第二端136(其可被称为支架的心室脉方面)之间。支架130可包括一个纵向柱132，如果需要的话，用于附连支架130的生物假体的各个连合延伸部。即，对于三小叶的生物假体可提供三个短柱132。
图19示出了另一示范的可供无支架生物假体附连的支架框架140，诸如图1-7所示的任意的生物假体。该支架140包括丝件结构，其布置成沿着其长度大致规则的对角十字交叉图形。该支架140还包括位于一端处的通向丝件的球根形状。生物假体的连合延伸部可附连到支架140的特殊丝件上，以使部件彼此牢固地附连。
图14和15示出了用牛颈静脉或管覆盖物制成的瓣膜190的另一实施例，如以上参照图10和11所讨论的。管状组织覆盖物包括位于一端处的管状组织延伸部192，以提供附加的锚固特征，从而保证阻止外科无缝线植入物的迁移。组织延伸部192定位在支架的流出侧上，并可包括在动脉切开术的范围之内，以进行大动脉瓣膜更换。或者，也可用于肺动脉和/或右心室流出流道的重建，以便进行肺动脉瓣膜更换手术。为了使用大动脉瓣膜更换的瓣膜190，需要将窗口切入在支架的窦区域内的管子内，以使冠状动脉无障碍流动。在该实施例中，管状覆盖物(例如，牛颈静脉部分)放置在支架的外表面上，然后，将瓣膜放置在支架的内部区域内。单根缝线将瓣膜近端和牛颈静脉固定到支架的近端冠部。瓣膜连合柱和远端牛管用中断的抗吊床(anti-hammocking)缝线固定到支架单元，例如，在固定组织和维持小叶接合所需的部位处进行固定。
应该指出的是，在本文所示和所述的多个支架实施例中，支架的某些部分的长宽比可与所示的稍有不同。此外，这里所述的支架实施例可进行修改而包括用于附连瓣膜组织的附加结构，例如，在许多实施例中所述的垂直支架柱。
图16和17示出了支架，生物假体使用经由导管递送方法附连到该支架上以实施植入手术。尤其是，图16示出了支架150和附连的生物假体160，它们各处于其至少部分地受压缩的结构中。图17示出了支架150和生物假体160，它们处于通过气囊型递送系统而至少局部膨胀状态中。在所示的实施例中，生物假体160包括扇贝形开口或区域162，其可定位成使生物假体和冠状动脉之间流体地连通。扇贝形开口162各自定位在生物假体的连合延伸部164之间。
沿着生物假体160的各扇贝形开口162的边缘的诸点可附连到支架150的某些预定的丝件。在所示的实施例中，支架150包括多个布置成相对狭窄的V形结构152的丝件，该结构152相对于支架150的中心轴线纵向地延伸。在该实施例中，支架150设有一个与各个连合延伸部164相对应的V形结构152，以及一个与延伸部164之间的各个区域(例如，扇贝形区域162)相对应的V形结构152。用于将生物假体附连到支架的缝线型式包括提供可沿着V形结构滑动的缝线，以便在生物假体的压缩和膨胀过程中，允许部件相对于彼此移动，并允许支架和其附连的生物假体的尺寸作必要地变化。该种缝线沿支架丝件的移动可防止应力产生或将应力减到最小，否则应力会产生在缝线上，在装置压缩和/或膨胀过程中，当部件再进行构造时使得可供的运动范围较小。
将本发明的任意可气囊膨胀的支架递送到植入部位可经由皮肤来实施。一般而言，这包括提供经由导管的组件，该组件包括递送导管、气囊导管和引导丝件。这种类型的某些递送导管在本领域内是公知的，它们形成内腔，气囊导管容纳在该内腔内。气囊导管又形成一内腔，引导丝件可滑动地设置在该内腔内。此外，气囊导管包括流体连接到充气源的气囊。应该指出的是，如果植入的支架是自膨胀型支架，则就不需要气囊，而可使用护套或其它的约束装置，将支架维持住其压缩状态中，直到支架展开为止。在任何情形中，对于诸如图16和17所示的支架150那样的可气囊膨胀的支架，经由导管的组件合适地定尺寸，以便理想地经由皮肤接近于植入部位。例如，经由导管的组件可合适地定尺寸，以便通过颈动脉、颈静脉、锁骨下静脉、股动脉或股静脉等处的开口递送到心瓣膜。基本上，可形成任何经由皮肤的脉间的穿透，以便于使用经由导管的组件。
在递送之前，支架安装在气囊上，处于尽可能小的收缩状态中而不造成支架结构永久变形。与膨胀状态相比，支承结构被压缩到其自身和气囊上，因此形成比膨胀状态中的内直径减小的内直径。尽管该描述参照了气囊膨胀支架的递送，但同样基本的程序也可适用于自膨胀的支架，其中，递送系统不一定包括气囊和气囊的膨胀，但较佳地包括护套或某些其它类型构造的使用，以维持支架处于压缩状态中，直到它为展开而被释放为止。
利用安装到气囊上的支架，经由导管的组件通过递送导管且经由皮肤的开口(未示出)递送到患者体内。通过将引导丝件插入患者体内，来定位植入部位，该导向丝件从递送导管的远端延伸，使气囊导管缩回到递送导管内。该气囊导管然后沿着引导丝件从递送导管朝向远处前进，使气囊和支架相对于植入部位定位。在一替代实施例中，支架通过最小创伤外科切口(即，非经由皮肤地)被递送到植入部位。在另一替代实施例中，支架通过打开心脏/胸部的外科手术被递送。在本发明支架的一个实施例中，支架包括辐射透不过的、发生回波的或MRI可见的材料，以便于目视确定支架是否合适放置。替代地，其它已知的外科可视辅助手段也可用于支架的使用。有关支架放置在心脏内的所述技术，可用于监视和纠正支架沿纵向方向相对于其定位的解剖学结构的长度的放置。
一旦支架合适地定位，就操作气囊导管来对气囊充气，因此，将支架过渡到膨胀状态。替代地，如果支承结构由形状记忆材料形成，那么，通过移去外力(例如，护套)，就可允许支架膨胀到其膨胀状态。
本发明现已参照若干个实施例进行了描述。仅为了使理解明晰，已经给出了以上详细的描述和实例。从中要理解到没有不必要的限制。本技术领域内的技术人员将会明白到，在所述的实施例中可作出许多变化，而不会脱离本发明的范围。因此，本发明范围应局限于这里所述的结构，且仅由权利要求书的语言和这些结构的等价物所描述的结构来限定。

Claims (13)

1.一种支架化瓣膜，包括：
可压缩和膨胀的支架结构，其包括具有内部区域和纵向轴线的大致管状本体部分；以及
至少部分地定位在支架结构的管状本体部分的内部区域中的生物假体瓣膜，其包括：
外管状部分，其包括至少两个连合延伸部和有多个小叶从中延伸出来的内壁；以及
在相邻的连合延伸部之间延伸的至少一个扇贝形部分；
其中，至少两个连合延伸部用附连材料固定至支架结构，该附连材料可沿着支架结构滑动，以使瓣膜沿着其纵向轴线相对于支架结构自由移动。
2.如权利要求1所述的支架化瓣膜，其特征在于，所述至少一个扇贝形部分中的每一个固定至支架结构。
3.如权利要求1所述的支架化瓣膜，其特征在于，所述至少一个扇贝形部分中的每一个被设计成：当植入到患者的大动脉中时，所述扇贝形部分与冠状动脉相对应。
4.如权利要求2所述的支架化瓣膜，其特征在于，所述扇贝形部分被缝合至支架结构，以便它们可相对于支架结构可滑动。
5.如权利要求1所述的支架化瓣膜，其特征在于，支架结构因外部压缩力的去除可从压缩状态膨胀自膨胀至膨胀状态。
6.如权利要求1所述的支架化瓣膜，其特征在于，支架结构因向外膨胀力的施加可从压缩状态膨胀膨胀至膨胀状态。
7.如权利要求1所述的支架化瓣膜，其特征在于，生物假体瓣膜的外管状部分包括三个连合延伸部。
8.如权利要求7所述的支架化瓣膜，其特征在于，生物假体瓣膜包括三个小叶。
9.一种支架化瓣膜，包括：
可压缩和膨胀的支架结构，其包括大致管状本体部分，该管状本体部分具有内部区域、外部表面、纵向轴线、流入端和流出端；
管状组织材料，其至少部分地覆盖支架结构的外部表面并延伸超过支架结构的流出端；以及
附连到支架的内部区域的多个小叶。
10.如权利要求9所述的支架化瓣膜，其特征在于，管状组织材料包括牛颈静脉。
11.如权利要求9所述的支架化瓣膜，其特征在于，管状组织材料包括允许流体无阻碍地流动的至少一个小孔。
12.如权利要求10所述的支架化瓣膜，其特征在于，包括位于管状组织材料的各窦区域处的小孔，所述下孔允许冠状流体无阻碍地流动。
13.如权利要求9所述的支架化瓣膜，其特征在于，还包括单根缝合线，小叶的近端和管状组织材料沿着该缝合线在支架结构的近端处固定到冠部上。
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US9968444B2 (en) 2018-05-15
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US20100305685A1 (en) 2010-12-02
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