CN101505687A - 人工瓣膜植入系统 - Google Patents

人工瓣膜植入系统 Download PDF

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CN101505687A
CN101505687A CN200780031341.3A CN200780031341A CN101505687A CN 101505687 A CN101505687 A CN 101505687A CN 200780031341 A CN200780031341 A CN 200780031341A CN 101505687 A CN101505687 A CN 101505687A
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treatment device
medical treatment
butt joint
sleeve pipe
order
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D·C·福斯特
B·贝基
B·沃尔什
S·赫内维尔德
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AorTx Inc
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2220/0083—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Abstract

本发明描述了人工瓣膜移植的方法和系统，尤其涉及在原生的瓣膜狭窄及瓣膜不全的部位安装人工瓣膜。题述装置、系统及相关的对接展开技术和移植对接技术可在经皮瓣膜更换过程中采用。

Description

人工瓣膜植入系统
发明背景
心脏瓣膜疾病及其它异常影响来自心脏的正常血液流动。两类心脏瓣膜疾病是心脏瓣膜狭窄和心脏瓣膜不全。心脏瓣膜狭窄是指心脏瓣膜由于心脏瓣膜组织硬化而不能完全打开。心脏瓣膜不全是指因允许血液回流到心脏中而造成低效率的血液循环的心脏瓣膜。
药物可用于治疗某些心脏瓣膜异常，但是许多情况均需要利用人工心脏瓣膜来置换原生的心脏瓣膜。尽管人工心脏瓣膜可用于置换任何原生的心脏瓣膜(主动脉的、二尖瓣膜的、三尖瓣膜的或肺部瓣膜)，但主动脉瓣膜或二尖瓣膜的修复或置换是最常见的，因为其位于压力最大的心脏左侧。
常规的心脏瓣膜置换外科手术包括通过纵向切开胸腔而接触到患者胸腔中的心脏。例如，正中胸骨切开术需要切过胸骨，并强制将胸廓的相对的两半分开，以便接触到胸腔和心脏内部。之后使患者的心肺动脉分流，这包括使心脏停止跳动以允许接触内部腔管。这种开心术特别具有侵害性，并且涉及到超长且困难的康复周期。
人工瓣膜的经皮植入是一种优选的手术，因为手术在局部麻醉的情况下进行，不需要心肺动脉分流，并且较少创伤。多种类型的人工瓣膜可适用于这种用途。一种类型采用支架状的外主体及附接到其上的内瓣膜小叶，以提供单向的血液流动。这些支架结构为了输送到预期的部位而沿径向收缩，然后扩展/展开而获得环形的管状结构。另一种更为有利的类型由本文的受让人所提供。美国专利公布说明书No.2005/0203614(以下称作“’614申请”，该申请通过引用整体结合在本文中)描述了一种系统，在该系统中，多个嵌板限定了携带瓣膜小叶的植入体。这些人工瓣膜结构在收缩的状态下输送，然后在治疗位置打开和/或展开到扩展的状态。这种瓣膜的实例显示在图1A中。如图所示，人工瓣膜101适于携带具有多个小叶108的瓣膜107。瓣膜支承结构106包括多个嵌板109，其可从所显示的状态转变到如在’614说明书中所述的翻转状态。
对于任一种结构类型，需要患者的身体组织与人工体之间充分的接合，以保证植入定位并形成边缘密封。然而，当在原生瓣膜的位置处/原生瓣膜的包膜中植入人工装置时，原生瓣膜的状态可能妨碍配合。换言之，植入位置形状上的不规则性、表面特征、纹理和成分对于研制能够适应所有这些可变性的规则尺寸的植入物提出了挑战。
本发明的方面可选地解决了由与钙化的和/或不规则的瓣膜小叶及环形的几何构型相连接的人工部件所提出的问题。另外，在本领域的技术人员参阅了题述的公开内容之后，本发明的其它有利之处可变得显而易见。
发明内容
本发明内容通过示范性实施例的方式提供。该发明内容绝非意图对所附权利要求的范围施加限制。
相应而言，本文所述的系统和方法包括“对接”类型的装置，用于连接置换的人工瓣膜。在部分示范性的实施例中，这些对接装置为套管的形式，该套管适于将瓣膜主体固定在中心腔管中，并与围绕瓣膜主体边缘的原生组织连接。对接套管可适于在原生瓣膜或原生血管与瓣膜主体之间提供密封。
附图说明
本文提供的附图不必按比例绘制，为了清晰起见对部分构件和特征进行了放大。各附图示意性地显示了本发明的方面。还可以想到偏离所显示实施例的本发明的变型。
图1A是显示示范性的人工瓣膜的透视图。
图1B是显示相对于心脏绘制的对接系统的示范性实施例的说明性视图。
图2A-C是显示对接系统100的示范性实施例的截面图。
图3A-B是分别显示对接套管另外的示范性实施例的轴向和径向截面图。
图4A-B是分别显示对接套管的另一个示范性实施例的轴向截面图和透视图。
具体实施方式
与已知系统不同的是，本文所描述的系统和方法的方面利用有限的植入-固位连接设计了比简单的对接环更多的部分。在本文所描述的系统和方法中，套管适于容纳至少一半瓣膜主体，更典型地适于容纳整个瓣膜主体。这种重叠可供瓣膜/套管连接或以下详细描述的固定方法之用。图1B是显示对接系统100的说明性视图，对接系统100具有如在’614说明书中所述的人工瓣膜101的支承结构106，以及适于容纳瓣膜支承结构106的相应的对接套管102。对接套管102可安放在对应于原生瓣膜(如患者的心脏104的主动脉103内的主动脉瓣膜)存在的位置。
本文所描述的系统和方法的另一方面在于，本文所描述的套管可提供空间填充功能，以分别提供与不规则的组织及具有规则形状如圆形、卵形或椭圆形的中心腔管的良好连接，从而适应相应的瓣膜主体的几何构型，这一点使其与已知的支架状的对接结构和简单的支架-移植物对接结构相区别。换言之，对接套管设置成适于或占用空间和/或分几部分地压缩或膨胀，以提供良好的血管侧连接，并为了瓣膜主体固位而为内腔管提供比植入位置更规则的几何构型。
图2A-C是显示在主动脉103中展开的各阶段中人工瓣膜101的示范性实施例的截面图。在该实施例中，对接套管102构造为具有可变厚度的组织移植物，以适应下层的血管组织(在该实例中，在主动脉103内)。当然，在其它实施例中，对接套管102可包括人造材料和/或可以这种方式构造，即对接套管102与下层组织并不完全一致。图2A显示了在可膨胀的部件(例如球囊)110上携带的移植物102，可膨胀的部件110处于其未膨胀的状态并布置在细长的部件(例如导管杆)111上。图2B显示了抵靠主动脉103的壁及填充窦112而处于展开构型的移植物102。移植物102的展开通过球囊110的膨胀实现。图2C显示了在移出球囊110及杆111并且瓣膜结构106(小叶未示出)展开之后的移植物102。此处可以看出，结构106具有比移植物102更短的长度，使得在置换结构106时具有更大的自由度。移植物102还提供了与下层组织一致的空间填充物。
这种空间填充物可由顺应性主体或主体部分(例如生物相容性的“海绵”泡沫，如膨胀的PTFE、可偏转的嵌板或用于金属材料如NiTi的片簧、多微孔的聚合物或金属/金属合金等)、多成分/多部分的主体或复合材料主体、或带有刚性的植入-连接腔管及可膨胀的外部(例如由水凝胶提供，或经由空气、盐水或另一种生物相容性的流体由永久可膨胀的结构提供)的主体提供。
对于多成分的套管主体，内外管状(例如圆筒形)部分可在其间设有弹性介质。为此目的可采用多个弹性梁或金属弹簧(卷簧、扭簧、之字形簧等)元件。作为备选，可利用带有置入球囊(可膨胀或不可膨胀)的空气弹簧的方法。在后一种情况下，内外套管壳体之间无需额外的密封元件。然而，在前一种情况下，可采用一种或多种缓冲结构(例如由织物/纤维提供)来对主体进行密封，以防意外的血液流动或血液流通/血液泄漏。为了避免不经意地提供易于导致血栓形成的空腔，多件式的套管主体通常在两端均进行密封。
图3A-B是分别显示对接套管102另外的示范性实施例的轴向截面图和径向截面图，其中对接套管102具有内套管114和外套管115。在图3A中，内套管114(还可以是瓣膜支承结构106)及外套管115利用多个弹性元件117以展开的构型相对于彼此间隔开，该多个弹性元件在本实施例中为卷簧，位于内套管114的外表面与外套管115的内表面之间且在其间施加力。弹性元件117用来提供与下层组织的一致性，以及使内套管114相对于外套管115居中。空区域116构造成用以容纳瓣膜支承结构106(未示出)。在该实施例中为柔性织物的盖子118安放到套管114与套管115之间的间隙上，以密封其间的区域来防止血液流动。
在图3B中，对接套管102显示为处于示范性的中间的未展开构型中。在此，套管114和115处于与在所结合的’614申请所述类似的“三角星”构型中。此处，装置102具有以星形方式布置的三部分123。根据该构型，通过使各部分朝向中心轴线124卷起可进一步缩减装置的轮廓。通过使各嵌板121和122按与在’614申请中所述类似的方式分别朝向装置的中心轴线124翻转或偏转，可使套管114和115进入该构型中。铰链119和120分别包含在嵌板121和122之间，以便于在三角星构型与展开的构型之间进行转换。尽管弹簧元件117还可以看到，但是盖子118为了清晰起见没有示出。
套管的长度可如以上所暗示而变化。为了桥接不规则的组织如动脉窦，对接套管可相对于瓣膜主体而延长。
在用于植入基于本发明的对接套管和人工瓣膜的过程中，可执行各种组织修正技术，如在共同受让的临时专利申请序号为60/805,333的“Prosthetic Valve Implant Site Preparation Techniques”中所描述的组织修正技术，该临时专利申请于2006年6月20日提交，其通过引用整体结合在本文中。然而，在多种情况下，当前的发明可使上述方法无不良作用。
在本发明的一个变型中提供了一种方法，在该方法中，对接套管位于在瓣膜成形过程中期望其植入的位置。在穿过原生的瓣膜小叶之后，球囊膨胀以同时打开小叶并使对接套管展开。
为了在心脏搏动手术过程中方便地利用连接瓣膜来完成操作，而不在延长的时段内损害患者的血液动力学特性(假定原生的瓣膜小叶固定在对接套管后面)，瓣膜输送装置还可以已经定位在主动脉中，用于在对接套管或对接站点展开后立即插入瓣膜主体。通过接触到患者各条腿中的股动脉以将不同的植入输送系统(一个来自右侧，一个来自左侧)送入主动脉弓中而促进这种情况，其中主动脉弓中有足够的空间来容纳该两种植入输送系统。
作为备选，可提供临时的瓣膜结构(例如在美国专利说明书No.2004/0225354中所描述的)，以允许套管前移和输送、取出其输送导管或引导物，以及替代用于次级植入输送的瓣膜主体输送引导物。美国专利公开号2001/0044591公开了用于经皮植入输送的其它方法，可备选地采用该方法用于输送对接套管及瓣膜主体。
如上所述，对接套管可在球囊上输送-这类似于移植物的输送。在植入物包括多个柔性和/或铰接的小叶的其它变型中，对接套管可按与紧接在下面所描述的瓣膜主体输送的方法相同的方式进行输送。
具体地讲，在美国专利公开号2005/0203614中所述的人工瓣膜组件的输送中，在使题述的输送系统经过导线前移到治疗位置之后，输送系统的外护套收缩以露出输送管。然后，所提供的夹持器相对于输送管转动(或者输送管相对于夹持器转动)，以便使人工瓣膜的折叠部分伸直，并经由输送管的纵向槽沿径向向外延伸。然后，输送管收缩(或夹持器前移)，以便使人工瓣膜(由指状物所限制)从远端前移出输送管。随后，夹持器相对于人工瓣膜收缩，将人工瓣膜释放到治疗位置。翻转的部分然后优选地恢复到膨胀状态，使瓣膜停靠在身体腔管(例如主动脉瓣膜根部，或其它生物学上可接受的主动脉位置)的内表面上。如需要，可通过在输送导管或其它载体上所携带的适当的膨胀部件如膨胀球囊或延伸的网状构件(在本文的其它部分有所描述)提供人工瓣膜额外的膨胀。
在其它方法中，不同类型的人工瓣膜在对接套管中输送并展开。在任何情况下，或者是瓣膜主体或者是对接套管的腔管(或者是两者)可尤其适应于在构件之间提供固定连接。这种适应可涉及互补的VELCRO类型的钩、凸出部分、尖齿和环匝、凹窝、网格空间和/或切口。否则，摩擦型连接或过盈配合可将主体固定在一起。用于固定构件相对位置的另一方式涉及磁体。可提供多个离散磁性的元件和/或铁磁性的元件。否则，一个或两个部件可至少部分地由浸磁的材料(如聚合体片)构造。
基于本发明另一个可能独立的方面，所有方法的共同点在于植入物的大部分轴向长度或整个轴向长度与对接套管相接合的方式。优选的瓣膜主体变型具有瓣膜小叶设定在其中的轴向长度。这些“高壁”可有助于保护小叶(尤其是当提供闭合壁的瓣膜主体结构时)，并且就侧向稳定性而言可提供有利的对接部件连接，以及为了部件之间坚固的摩擦接合、互锁接合或其它类型的接合而提供显著的表面面积。因为瓣膜主体不会缝合到对接套管(或者其内部或者其外部-当可适用时)上使得这种接触达到最大程度，并同时仍然使装置尺寸最小以有助于可输送性，故对于提供能够处理数百万次脉动血压循环的安全结构是至关重要的。
关于对接套管的构造，对于其瓣膜主体，其构造可大致遵循’614申请中的构造。用于提供构造成如’614申请中所提出瓣膜主体的各种“三角星”及其它类型的对接套管的材料和组装方法是经过特别构思的。在某些情况下可对构造方法进行变更，以便提供双壁、双筒体或双壳体的瓣膜对接/固位套管(如本文所提供的)。脑海中有了这样的标的之后，本领域的技术人员可应用相关的教导内容。一般而言，瓣膜主体为聚合物的、NiTi合金(其中Af设定为超弹性或SMA用途)、β型钛合金、或其它适当的生物相容性的材料或其它具有稳健的生物相容性涂层的材料。
无论如何构造，均希望能够利用大部分闭合或不间断的套管壁，以避免原生的小叶向内迁移，这样会损害人工小叶。在其它情况下，可希望在套管壁中精巧地确定开放区段的位置，以便在无重叠材料的情况下容纳嵌套的内外部分。换言之，使用嵌套的筒体/壳体可避免重叠，重叠将导致更厚的壁区段，这样会更加难以控制进入横截面减小的轮廓中；或者在尺寸上层叠将使得在经皮输送系统中的配合变得困难。
在后一种情况下，整体瓣膜系统的开放性可通过以下方式得到保证，即协调瓣膜主体的构型与对接套管的构型，使得当瓣膜主体就位时，设置在对接套管对的外部件上的孔被覆盖或被跨过。
图4A-B是分别显示对接套管102的另一个示范性实施例的轴向截面图和透视图，该对接套管102具有内套管114和外套管115。图4A显示了展开过程中的套管102。此处，外套管115具有构造成用以容纳内套管114(还可以是瓣膜支承结构106)的孔126。内套管114通过在该实施例中为织物128的密封装置联接到外套管115上。内套管114可定位在孔126中，以防两个套管114和115层叠(即在套管114和套管115之间增加了总体壁厚的重叠)。图4B显示了处于三角星构型时的该实施例。织物128未示出。
在基于本发明的某些方法中，对接套管和瓣膜主体可同时输送。这种方法可避免需要上述临时瓣膜的方法。在又一种方法中，装置(即对接套管和瓣膜构件)串联地位于单个输送引导物上，以便允许利用同一输送装置快速、顺序地展开。
在方法的另一方面，各人工瓣膜主体及对接套管的尺寸可按多种方式确定。美国专利申请序列号11/420,189中所描述的技术对于这一点是有益的，该专利申请于2006年5月24日提交，其名称为“Assessment of Aortic Heart Valve to Facilitate Repair orReplacement”。根据这种测量，可从库存中为特定的患者选择适当尺寸的对接套管和瓣膜主体，或不同尺寸的修补物的有组织的嵌板。
以下对本发明的各种示范性的实施例进行描述。可在非限制性的意义上参照这些实例。这些实例提供用来说明本发明更为广泛的可应用方面。所描述的发明可进行多种变化，并且对等同物进行替换，而不背离本发明的本质精神和范围。另外，可进行多种变更，以使具体的情况、材料、物质组成、进程、进程环节或步骤适应本发明的目标、精神或范围。另外，本领域的技术人员可认识到，本文所描述及所显示的各单独的变型具有分立的构件及特征，这些分立的构件及特征可易于与任何其它几个实施例的特征分开或进行组合，而并不背离本发明的范围或精神。所有这些变更旨在处于所附权利要求的范围内。
用于执行题述方法所描述的任何装置可以包装组合的方式提供，以便用于实施该方法。这些供应“套件”可另外包括使用说明，并与通常用于此目的的方式一样包装在消毒盘或容器中。
本发明包括可使用题述装置执行的方法。该方法可全部包括提供这种适当装置的环节。这种供应可由最终用户执行。换言之，“提供”环节仅仅要求最终用户获得、接近、处理、定位、设立、启动、供电或以其它方式提供题述方法中所需的装置。本文所陈述的方法可按所陈述事件逻辑上可能的任意顺序执行，以及按事件的陈述顺序执行。
以上阐述了本发明示范性的方面以及有关材料选择及制造的细节。至于本发明的其它细节，其可以被视为与以上所参照的专利及说明书相关联，以及本领域的技术人员通常了解或认识到的内容。例如，本领域的技术人员可以认识到，润滑涂层(例如亲水聚合物如基于聚乙烯吡咯烷酮的合成物、含氟聚合物如聚四氟乙烯、亲水凝胶或硅橡胶)可在需要时与装置一起使用，以便于进行低摩擦操纵或前移到治疗位置。对于基于方法的本发明的方面，就通常或逻辑上采用的附加的环节而言，以上观点也适用。
另外，尽管参照几个实例对本发明进行了说明，可选地结合了多种特征，但是本发明并不受限于关于本发明的各种变型描述或显示为所想到的实例。所描述的发明可进行多种变化，并且等同物(或者在本文中进行了陈述，或者为了简明起见而未包括)可进行替换，而不背离本发明的本质精神和范围。另外，在提供数值范围的情况下，可以理解，在该范围的上限和下限之间的每一个中间值，以及在该陈述的范围内任何其它陈述的数值或中间值均包含在本发明内。
同样地可以想到，所述创造性变型的任何可选的特征可以独立地阐述并要求保护，或者与本文所述的任何一个或多个特征一起阐述并要求保护。对单数项的引用包括了相同项的复数形式存在的可能性。更具体地讲，如本文及所附权利要求所用，单数形式“一”、“一个”、“所述”和“该”也包括复数对象，除非另有明确的说明。换言之，冠词的使用在上述描述及以下权利要求中允许“至少一个”的题述项。还进一步注意到，权利要求可表述成排除任何可选的要素。因此，对于这种排它性的用语如“单独”、“仅”等与权利要求要素的陈述相关联的术语的使用，或者对于“负面”限制的使用，本陈述意图用作前提基础。
在不使用这种排它性用语的情况下，权利要求中的用语“包括”允许包含任何附加的要素-无论给定数目的要素是否在权利要求中列举，或者附加的特征可视为改变了权利要求中所阐述的要素的特性。除了本文具体的限定之外，本文所用的所有技术用语及科学用语应当被赋予通常所理解的尽可能宽泛的含义，并同时保持权利要求有效。
本发明的外延并不受限于所提供的实例和/或题述说明书，而是仅由权利要求的范围所限制。

Claims (50)

1.一种医疗装置，包括：
人工瓣膜支承结构；以及
对接套管，其构造成用以与所述支承结构相连接并构造成用于植入在患者的血管中。
2.根据权利要求1所述的医疗装置，其特征在于，所述对接套管构造成用以置换原生组织。
3.根据权利要求1所述的医疗装置，其特征在于，所述对接套管构造成用以提供与所述原生组织的密封件。
4.根据权利要求1所述的医疗装置，其特征在于，所述对接套管构造成用以抵靠所述原生组织锚固。
5.根据权利要求1所述的医疗装置，其特征在于，所述对接套管包括组织移植物。
6.根据权利要求5所述的医疗装置，其特征在于，所述对接套管构造成用以与所述原生组织相适应。
7.根据权利要求6所述的医疗装置，其特征在于，所述原生组织包括至少部分地钙化的瓣膜小叶。
8.根据权利要求6所述的医疗装置，其特征在于，所述对接套管具有可变的厚度。
9.根据权利要求8所述的医疗装置，其特征在于，所述对接套管构造成用以与主动脉窦相适应。
10.根据权利要求8所述的医疗装置，其特征在于，所述对接套管具有带有规则的截面形状的内腔管。
11.根据权利要求6所述的医疗装置，其特征在于，所述医疗装置还包括：
细长的部件；
与所述细长的部件相联接的可膨胀的部件，所述可膨胀的部件构造成用以使所述对接套管展开。
12.根据权利要求11所述的医疗装置，其特征在于，所述医疗装置还包括与所述瓣膜支承结构相联接的人工瓣膜。
13.根据权利要求11所述的医疗装置，其特征在于，所述对接套管构造成用以从未展开的状态转变到展开的状态，所述未展开的状态适于经由患者的脉管系统前移。
14.根据权利要求1所述的医疗装置，其特征在于，所述对接套管是顺应性的。
15.根据权利要求14所述的医疗装置，其特征在于，所述对接套管是像海绵的。
16.根据权利要求1所述的医疗装置，其特征在于，所述对接套管包括内套管和外套管。
17.根据权利要求16所述的医疗装置，其特征在于，所述对接套管还包括联接在所述内套管与所述外套管之间的弹性部件。
18.根据权利要求17所述的医疗装置，其特征在于，所述弹性部件构造成用以在所述内套管与所述外套管之间施加力，以便使所述外套管至少部分地与所述原生组织相适应。
19.根据权利要求18所述的医疗装置，其特征在于，所述弹性部件构造成用以在所述内套管与所述外套管之间施加力，以便使所述外套管与所述原生组织相适应。
20.根据权利要求18所述的医疗装置，其特征在于，所述医疗装置还包括密封部件，所述密封部件构造成用以密封所述内套管和所述外套管之间的空间。
21.根据权利要求18所述的医疗装置，其特征在于，所述内套管和所述外套管构造成用以从未展开的状态转变到展开的状态，所述未展开的状态适于经由患者的脉管系统前移。
22.根据权利要求18所述的医疗装置，其特征在于，所述弹性部件为包括以下部件的组中的一种：卷簧、扭簧、之字形簧和球囊。
23.根据权利要求18所述的医疗装置，其特征在于，所述弹性部件包括空气。
24.根据权利要求18所述的医疗装置，其特征在于，所述弹性部件构造成用以使所述内套管居中。
25.根据权利要求18所述的医疗装置，其特征在于，所述弹性部件为第一弹性部件，且其中，所述对接套管还包括联接在所述内套管和所述外套管之间的第二弹性部件。
26.根据权利要求16所述的医疗装置，其特征在于，所述内套管包括多个铰链。
27.根据权利要求16所述的医疗装置，其特征在于，所述外套管包括多个铰链。
28.根据权利要求16所述的医疗装置，其特征在于，所述内套管包括多个可偏转的嵌板。
29.根据权利要求16所述的医疗装置，其特征在于，所述外套管包括多个可偏转的嵌板。
30.根据权利要求16所述的医疗装置，其特征在于，所述内套管构造成用以从三角星构型转变。
31.根据权利要求16所述的医疗装置，其特征在于，所述外套管构造成用以从三角星构型转变。
32.根据权利要求16所述的医疗装置，其特征在于，所述外套管包括构造成用以容纳所述内套管的孔。
33.根据权利要求32所述的医疗装置，其特征在于，所述内套管联接到所述外套管上。
34.根据权利要求33所述的医疗装置，其特征在于，所述内套管利用密封部件联接到所述外套管上。
35.根据权利要求33所述的医疗装置，其特征在于，所述内套管利用柔性部件联接到所述外套管上。
36.根据权利要求1所述的医疗装置，其特征在于，所述对接套管通过弹性部件联接到所述瓣膜支承结构上。
37.根据权利要求36所述的医疗装置，其特征在于，所述弹性部件构造成用以在所述瓣膜支承结构与所述对接套管之间施加力，以便使所述对接套管至少部分地与所述原生组织相适应。
38.根据权利要求37所述的医疗装置，其特征在于，所述弹性部件构造成用以在所述瓣膜支承结构与所述对接套管之间施加力，以便使所述对接套管与所述原生组织相适应。
39.根据权利要求37所述的医疗装置，其特征在于，所述医疗装置还包括密封部件，所述密封部件构造成用以密封所述内套管和所述外套管之间的空间。
40.根据权利要求37所述的医疗装置，其特征在于，所述瓣膜支承结构与所述对接套管各自构造成用以从未展开的状态转变到展开的状态，所述未展开的状态适于经由患者的脉管系统前移。
41.根据权利要求37所述的医疗装置，其特征在于，所述弹性部件为包括以下部件的组中的一种：卷簧、扭簧、之字形簧和空气弹簧。
42.根据权利要求37所述的医疗装置，其特征在于，所述弹性部件构造成用以使所述瓣膜支承结构居中。
43.根据权利要求37所述的医疗装置，其特征在于，所述弹性部件为第一弹性部件，所述对接套管还包括联接在所述瓣膜支承结构与所述对接套管之间的第二弹性部件。
44.根据权利要求1所述的医疗装置，其特征在于，所述瓣膜支承结构构造成用以从三角星构型转变。
45.根据权利要求1所述的医疗装置，其特征在于，所述对接套管构造成用以从三角星构型转变。
46.根据权利要求1所述的医疗装置，其特征在于，所述对接套管包括构造成用以容纳所述瓣膜支承结构的孔。
47.根据权利要求1所述的医疗装置，其特征在于，所述瓣膜支承结构利用密封部件联接到所述对接套管上。
48.根据权利要求1所述的医疗装置，其特征在于，所述瓣膜支承结构利用柔性部件联接到所述对接套管上。
49.根据权利要求1所述的医疗装置，其特征在于，所述对接套管包括NiTi合金。
50.根据权利要求1所述的医疗装置，其特征在于，所述瓣膜支承结构包括NiTi合金。
CN200780031341.3A 2006-06-21 2007-06-20 人工瓣膜植入系统 Pending CN101505687A (zh)

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US20090228098A1 (en) 2009-09-10
EP2059191A4 (en) 2010-03-31
AU2007260951A1 (en) 2007-12-27
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US20120150287A1 (en) 2012-06-14

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