CN110198683B - 假体二尖瓣膜装置 - Google Patents

假体二尖瓣膜装置 Download PDF

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CN110198683B
CN110198683B CN201880007705.2A CN201880007705A CN110198683B CN 110198683 B CN110198683 B CN 110198683B CN 201880007705 A CN201880007705 A CN 201880007705A CN 110198683 B CN110198683 B CN 110198683B
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mitral valve
prosthetic mitral
self
valve frame
expanding
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CN110198683A (zh
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杰弗里·W·钱伯斯
格雷戈里·G·布鲁克
约瑟夫·P·希金斯
萨拉瓦纳·B·库玛尔
詹森·S·迪德林
卡尔·A·卡巴罗夫斯基
罗伯特·J·撒切尔
詹姆斯·E·弗莱厄蒂
杰弗里·R·斯通
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4C Medical Technologies Inc
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • 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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

公开了用于将假体心脏瓣膜装置输送到心脏腔室用于扩张实施的输送系统、装置和方法的实施例。更具体而言，方法、系统和装置被公开，用于将自扩张假体二尖瓣膜装置输送到左心房，在输送期间不接合左心室、原生二尖瓣膜小叶或上环形表面下游的环形组织，并且在一些实施例中，心室、二尖瓣膜小叶和/或位于上环形表面下游的环形组织不被已输送、已定位并且已扩张的假体二尖瓣膜装置接合。

Description

假体二尖瓣膜装置
发明人
Jeffrey W.Chambers，梅普尔格罗夫，明尼苏达州，美国公民；
Gregory G.Brucker，明尼阿波利斯，明尼苏达州，美国公民；
Joseph P.Higgins，明尼通卡，明尼苏达州，美国公民；
Saravana B.Kumar，明尼通卡，明尼苏达州，印度公民；
Jason S.Diedering，明尼阿波利斯，明尼苏达州，美国公民；
Karl A.Kabarowski，梅普尔格罗夫，明尼苏达州，美国公民；
Robert J.Thatcher，布莱恩，明尼苏达州，美国公民；
James E.Flaherty，明尼通卡，明尼苏达州，美国公民；以及
Jeffrey R.Stone，明尼通卡，明尼苏达州，美国公民。
相关申请的交叉引用
本申请要求2017年1月19日提交的题为“SYSTEMS,METHODS AND DEVICES FORDELIVERY SYSTEMS,METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES”的美国临时申请No.62/448036的权益，其全部内容通过引用并入本文。
关于联邦资助的研究或开发的声明
不适用
通过引用并入
所有参考文献(包括但不限于本说明书中提及的出版物、专利申请和专利)通过引用并入本文，程度如同于以及效果如同于每个参考文献被具体地和单独地表明通过引用并入一样。
技术领域
本文所描述的发明涉及用于输送和/或定位心脏瓣膜的输送系统、装置和方法。
背景技术
人类心脏包括四个腔室和四个心脏瓣膜，其协助使血液向前(顺行)流动通过心脏。腔室包括左心房、左心室、右心房和左心室。四个心脏瓣膜包括二尖瓣膜、三尖瓣膜、主动脉瓣和肺动脉瓣。
二尖瓣膜位于左心房与左心室之间，并且通过用作防止向左心房中回流的单向瓣膜来帮助控制血液从左心房到左心室的流动。类似地，三尖瓣膜位于右心房与右心室之间，而主动脉瓣和肺动脉瓣是位于供血液流动离开心脏的动脉中的半月瓣。瓣膜均为单向瓣膜，具有小叶，其打开以允许向前(顺行)的血液流动。正常工作的瓣膜小叶在由反流血液施加的压力下关闭，以防止血液回流(逆行)到其刚刚流出的腔室中。
由于各种原因和/或状况(包括但不限于疾病、创伤、先天性畸形和衰老)，原生心脏瓣膜可能是或者变得功能失调。这些类型的状况可能导致瓣膜结构不能正常打开(狭窄故障)和/或不能正常关闭(反流)。
二尖瓣膜反流是由功能失调的二尖瓣膜引起的特定问题。二尖瓣膜反流由允许至少一些逆行血液流从右心房返回到左心房中的二尖瓣膜导致。该血液回流以一定的体积负荷对左心室造成负担，这可能导致一系列左心室代偿性适应和调整，包括重塑心室腔室尺寸和形状，其在二尖瓣膜反流的长期临床过程中显著地变化。
因此，原生心脏瓣膜(例如二尖瓣膜)通常可能需要功能性修复和/或协助，包括部分或完全置换。这种干预可以采取数种形式，包括开心手术和开心植入置换心脏瓣膜。参见例如美国专利No.4,106,129(Carpentier)，来获知一种手术，其是高度创伤性的、充满患者风险，并且不仅需要长期住院治疗，而且还需要非常痛苦的恢复期。
用于置换功能失调的心脏瓣膜的创伤性较小的方法和装置也是已知的，并且涉及经皮进入以及置换瓣膜的导管促进输送。这些解决方案中的大多数都涉及附接至结构支撑件(比如本领域公知的支架)的置换心脏瓣膜，或设计成在从输送导管释放后扩张的其它形式的线网。例如参见美国专利No.3,657,744(Ersek)；美国专利No.5,411,552(Andersen)。支撑支架的自扩张变型协助在对象心脏腔室或血管内定位瓣膜并将已扩张的装置保持就位。当装置在第一次定位尝试中没有恰当地定位(情况往往如此)，并且因此必须被重新捕获并在位置上被调节时，这种自扩张形式也存在问题。该重新捕获过程在已完全或甚至部分扩张的装置的情况下，需要将装置重新收缩到一点，其允许操作者将已收缩的装置缩回到输送护套或导管中，调节用于装置的入进位置，并且随后通过将在位置上已得到调节的装置向远侧重新部署到输送护套或导管外来重新扩张到适当位置。收缩已经扩张的装置是困难的，因为已扩张的支架或线网通常设计成实现扩张状态，其也抵聚缩或收缩力。
除了以上讨论的开心手术途径之外，还经由至少以下公知进入途径中的一种经皮实现进入所关注的瓣膜：经心尖、经股、经心房以及经中隔输送技术。
通常地，本领域专注于这样的系统和方法，其使用上述公知进入途径中的一种来允许收缩的瓣膜装置的部分输送，其中装置的一个端部从输送护套或导管得到释放，并且发生扩张用于初始定位，然后在适当定位得以实现时完全释放和扩张。例如参见美国专利No.8,852,271(Murray,III)；8,747,459(Nguyen)；8,814,931(Wang)；9,402,720(Richter)；8,986,372(Murray,III)；和9,277,991(Salahieh)；以及美国专利公开No.2015/0272731(Racchini)；和2016/0235531(Ciobanu)。
然而，公知的输送系统、装置和方法仍然遭受输送方法的显著缺陷，尤其包括定位和重新捕获能力和效率。
另外，公知的“置换”心脏瓣膜旨在用于完全置换原生心脏瓣膜。因此，这些置换心脏瓣膜物理地接合环形喉部和/或瓣膜小叶，从而消除原生瓣膜的所有剩余功能并使患者完全依赖于置换瓣膜。一般而言，维持和/或保持心脏瓣膜的原生功能是优选的解决方案，因此瓣膜的修补是优选的，而不是完全置换。显然，将存在这样的情况：原生瓣膜在介入植入手术之前已经几乎完全丧失功能，或者原生瓣膜在植入手术后继续丧失功能。优选的解决方案是输送和植入一种瓣膜装置，其将既作为补充功能瓣膜发挥功能，又能完全代替丧失其大部分或全部功能的瓣膜的原生功能。然而，下文描述的创造性解决方案将大体上适用于所有类型和形式的心脏瓣膜装置，除非另有说明。
最后，用于例如二尖瓣膜置换系统、装置和方法的公知解决方案需要两腔室解决方案，即，植入的置换瓣膜装置在左心房和左心室中均有参与和接合。通常地，这些解决方案包括在左心房中的径向扩张支架，其中锚定件或系缚件(设置成向下穿过环形喉部)从支架装置向下穿过环形喉部连接至左心室内的子环形表面、左心室腱索并且甚至到左心室壁表面中。
这种两腔室解决方案是不必要地笨重的，并且因此从严格的结构角度来说更难以输送和定位/重新捕获/重新定位。此外，两腔室解决方案在进行保持位置所需的心室锚定和/或系缚方面存在困难。另外，这些解决方案如上所述干扰原生瓣膜功能，因为设置在左心室内的装置部分必须前行通过瓣环、环形喉部和原生二尖瓣膜，从而破坏原生小叶的任何剩余的对合能力。另外，两腔室解决方案通常需要对一些原生组织进行创伤性锚定，从而导致不必要的创伤和潜在的并发症。
将进一步认识到的是，两腔室二尖瓣膜解决方案需要与锚定件、系绳及类似物精确的子环和/或心室接合，因为装置的心房部分不能充分地将其自身锚定到瓣环的上部和/或心房腔室。再次，本文中描述的创造性解决方案轻松地适用于单腔室或两腔室解决方案，除非另有说明。
本文中公开的数个发明的各个实施例尤其致力于这些问题。
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图12示出了本发明的一个实施例的侧视图。
具体实施方式
本发明的各种实施例在图中公开，用于经由至少以下公知的进入途径中的一个对所关注的瓣膜提供经皮进入：经心尖、经股、经心房以及经中隔输送技术。这些进入途径中的每个可以用于本文所公开的实施例。
因此，图1示出了具有两部式框架处于收缩构造的假体瓣膜装置100的一个实施例。收缩的装置的远侧部分102包括具有假体小叶具有支撑框架的一部分的瓣膜，并且被纵向可平移地且可旋转地限制在具有第一外径D的外护套104的管腔内。收缩的装置100的近侧部分106包括剩余的支撑框架，其与收缩的装置100的远侧部分102操作连接，并且被纵向可平移地且可旋转地限制在内护套108的管腔中，所述内护套108相对于外护套104至少纵向地可平移，并且其中外护套104相对于内护套108至少纵向地可平移。内和/或外护套108、104也可以相对于另一护套旋转地可平移。内护套108设置在外护套104的管腔内，并且因此内护套108包括小于外护套的外径D的第二外径D'。
图1的装置的优选构造包括收缩的装置100，其由具有近侧部分106和远侧部分102的一个单元组成，如图所示。外护套104可以缩回以首先使远侧部分102从外护套104的远侧端部110释放暴露，以便在心脏的对象腔室中初始扩张和定位。替代地，装置100的远侧部分102可以例如响应于内护套108的远侧平移或响应于抵靠装置100的近侧部分106进行推压的推杆，被向远侧推动以从外护套104的远侧端部110得到释放。在推杆的情况下，近侧部分106将最终被向远侧推出内护套106的较小管腔并进入外护套104的较大管腔中，在这里发生近侧部分106的临时二次扩张，接着在近侧部分106最终从外护套104的远侧端部110得到释放时发生二次定位扩张。
如果在与假体二尖瓣膜相关的左心房内扩张，则远侧部分102的下部可以抵靠左心房内的瓣环的上表面定位。
在该构造中，如果远侧部分102被适当地定位和释放/扩张，则可以根据以上结合远侧部分102的初始释放和扩张所描述的替代方法来开启和实现装置100的近侧部分106的二次释放和扩张。本领域的技术人员将认识到，一旦远侧部分102的初始定位扩张得以完成，则近侧部分106的二次定位扩张也将被适当地寻位和定位。
图1的构造在其各种实施例中允许通过两步框架定位扩张方法来输送装置100，其包括框架，其可以对于腔室(例如心房)尺寸略微过大。处于收缩形式的一些框架可以在纵向长度上高达任何腔室(例如心房)尺寸的2倍。因此，分阶段定位扩张方法对于输送是必要的。
现在转到图2A和2B，提供了假体瓣膜装置200，其包括支撑支架框架，在其中附接和/或支撑假体瓣膜，其中该设计包括具有扩张直径的两个部分(远侧部分202和近侧部分206，其中具有小叶205的假体瓣膜被保持/支撑在远侧部分202内)，这两个部分通过具有比两个部分202、206的扩张直径更小的直径的中央部分203连接。如图所示，两个部分202、206包括未变形且完全扩张的球体形状，但是可以使用其它形状，如本领域技术人员将容易理解的。某些实施例可以包括近侧部分206和远侧部分202中的至少一个具有扩张尺寸，其略大于对象腔室的尺寸(例如左心房尺寸)，以允许扩张锚定。另外，两个部分206、202中的每个的纵横比可以变化。
如图所示，具有瓣膜的收缩支架被保持在输送护套204的管腔内，且在其中保持或支撑装置200的远侧部分从输送护套204的端部得到释放，随后它在对象腔室(例如左心房)内定位扩张。当适当定位得以确认时，剩余的中央部分203(如果先前未与远侧部分202一起释放)和/或近侧部分206于是可以通过结合图1描述的方法得到释放并在位置上扩张，所述方法包括使用如上所述的内护套和/或推杆，以将装置200平移出外输送护套204的远侧端部。正如图1，该实施例包括两步或分阶段输送机制。图1和图2A/2B两组的实施例可以包括远侧部分202上的涂层或覆盖物，而近侧部分206可以包括由例如支架网格形成的开放框架。在图2A/2B的情况下，中央部分203也可以包括开放网格构造并且未被覆盖。图2B的虚线示出了一替代实施例，其中已扩张已输送的部分202包括铰接点212，以协助将远侧部分202内的小叶和假体瓣膜向下朝向原生瓣膜定向。
图3A、3B、4、5A和5B提供了具有支撑手段(例如支架式)的示例性假体瓣膜装置及相关示例性输送方法的进一步公开。因此，图3A示出了收缩的装置300，其处于输送护套304的管腔中，与被装置操作者致动的推/拉杆308操作地连通，所述推/拉杆能够将如图3A中的收缩的装置300向远侧平移出输送护套304的远侧端部310以用于定位扩张，并且相反地，如有必要，将如图3B中所示的已扩张的装置300拉回到输送护套304的远侧端部310中。推/拉杆308还可以在某些实施例中允许收缩的装置300在输送护套310的管腔内旋转，以在释放和扩张之前辅助定位。此外，推/拉杆308与收缩的装置300的操作连通可以包括与收缩的装置300的最近侧部分连接的螺丝或夹具释放机构311。装置300的基部或下部可以被组织或其它生物相容性材料覆盖，而装置的上部可以包括开放网格构造。
通常地，收缩的装置300被装载并定位在输送护套304内，且瓣膜部分305定向在向下位置，如图所示。这允许收缩的瓣膜装置305如图所示沿侧向定向被推出输送护套304，并且允许发生扩张的瓣膜装置300在从输送护套释放后被适当地定向到原生瓣膜和对象腔室，例如二尖瓣膜和左心房。
在某些情况下，对准线315可以从输送护套304平移到肺静脉(例如左上肺静脉PV)中，以协助装置300的定位和输送。
图4示出了在扩张期间且刚从输送护套304的外端部310输送之后的装置300的侧向输送，其中已输送装置大致竖直地定向并且对准，以定位在原生瓣膜上。
因此，如图5A和5B中最佳所示，假体瓣膜装置500可以被不对称地侧向输送(其中瓣膜部分505如图所示定向在底部上)，并且可以包括定位元件515，其与假体瓣膜装置500操作连接，并且其从输送护套504延伸，其中推管或定位元件515的至少远侧端部设置在肺静脉PV(例如，如图所示的左上肺静脉)内。该系统提供自定心系统，其可以在从输送护套504的远侧端部释放/平移收缩的假体瓣膜装置500后扩张。如图所示，一旦假体瓣膜装置500从输送护套504的远侧端部被输送后，推管508和相关的连接器511可以用于协助操控假体瓣膜装置500的定向。
现在转到图6A-6C，假体瓣膜装置600的输送使用了输送导管或护套604，其包括预弯曲的远侧部分620或适于能够弯曲的远侧部分620，以在心房内提供大致伸直的远侧部段。图6A提供了预弯曲实施例，其弯曲以允许装载假体瓣膜装置600在一定构造中，其将带瓣底部605在从输送导管或护套的预弯曲远侧部分620的远侧端部610(更具体地从预弯曲远侧部分620的远侧的已伸直远侧部段)释放后放置在适当位置。因此，如图所示，已收缩且可扩张的框架/支架的瓣膜支撑部分605在输送导管/护套604的管腔内是最远侧。预弯曲部分620允许带瓣部分605与示例性二尖瓣膜和/或其瓣环的上表面的轻松定向。
因此，具有如图6A中的弯曲远侧部分的输送系统允许假体瓣膜装置600定位在瓣环和原生瓣膜小叶上。当已定位在瓣环和原生瓣膜小叶上时，弯曲的输送导管或护套604可以向近侧单独地或与假体瓣膜装置600的近侧的推杆608或类似装置一起被取回，以释放并输送假体瓣膜装置600到左心房中并扩张已输送的装置600。值得注意的是，弯曲的输送导管或护套604在一些实施例中包括在左心房内并且位于弯曲部段620的远侧的伸直远侧端部，其中压缩态的假体瓣膜装置600绕着弯曲的输送导管或护套604的弯曲部分620受到平移和操控。压缩态的假体瓣膜装置600可以受助而绕着弯曲的输送导管或护套的弯曲部分620平移，即通过包括附接到植入物的远侧端部的缝合线、附接到植入物的远侧端部的拉线(延伸至输送导管或护套的近侧端部)，或通过利用图1的配置中在假体瓣膜装置的近侧部分和远侧部分之间的自然挠曲点，和/或通过如图2中的铰接点。
图6B和6C包括一种用以建立弯曲部分620的替代途径，其通过沿着护套或导管的底部表面提供一系列切口或锯齿609从而导致易于弯折的薄弱区域，来允许输送护套或导管604的远侧部分的弯曲。如图所示，拉线625沿着该底部薄弱切口或锯齿状区域附接至导管604的远侧端部610，并且设置成穿过导管/护套管腔到操作者，其可以在释放收缩的假体瓣膜结构600之前通过力F向近侧拉动线来实现期望的曲率，所述假体瓣膜结构600定向成如图6A中的收缩形式并且被释放以实际上直接在对象瓣膜或上环形表面上定位扩张。切口609可以完全延伸穿过导管/护套壁，或者可以仅仅是具有比导管/护套壁的其余部分更薄的导管/护套壁的部段。所示的切口609是均匀且大体方形的，但是可以使用其任何深度、形状和均匀或不均匀的间隔来实现弱化区域。
图7A和7B示出了对心脏腔室例如左心房进行示例性假体瓣膜例如二尖瓣膜置换或修补的输送系统，其使用如图7A中所示的输送导管或护套704，经中隔进入并加上附加的引导工具728，其用于在带瓣装置使用本文中描述的方法或装置从导管或护套704的远侧端部710被释放时帮助引导扩张的带瓣装置(未示出)。附加的引导工具728可以设置在例如上肺静脉PV内。引导工具728可以铰接地或旋转地附接至导管或护套704，从而允许工具728旋转就位。类似于图6B和6C中所示的拉线的拉线可以用于连接至工具728并将工具728操控就位。
图7B示出了两个输送系统，即用于对准和部署的第一输送系统800以及用于在必要时重新捕获和重新定位的第二输送系统850。输送系统中的一个，即第一输送系统800或第二输送系统850，可以经由经股进入方法进入对象心脏腔室，而另一输送系统可以经由另一经静脉进入方法进入对象心脏腔室。第一输送系统800因此可以包括如本文中其它地方描述的输送导管或护套804，而第二输送系统可以包括重新捕获和重新定位的导管或护套854，其在结构上类似于输送导管/护套804。
图8A和8B示出了实施例，其设计成促进假体心脏瓣膜在腔室例如左心房内的精确定位，包括但不限于自定心和荧光透视技术。在假体支架式瓣膜装置900的该实施例中，在假体瓣膜和小叶905被支撑在瓣膜装置的底部附近的情况下，装置900的上部可以分成如图8A中从顶部所示的子部。所示的情况提供了4个子部，但是其它数量的子部当然可以是有用的并且在本发明的范围内。如图所示，相对的子部是开放网格或开放线构造907，或者由呈一种帆908形式的织物构成。在该装置900输送到对象心脏腔室后，织物帆908将捕捉并使用血液流动的自然力来将装置框架900操纵到适当定位，随后在定位被确认时释放和扩张。
图8B是一种相关构思，但还包括瓣环间隔件919，其可以首先经由如本文中在先前所描述的输送导管/护套得到输送，并且在某些实施例中，间隔件可以利用定位在输送导管/护套的管腔内的引导线被引导就位，并且进一步移动出输送导管/护套的远侧端部，并且要么在腔室上环形表面附近(在近侧)，或者可以至少部分地设置在环形喉部内。一旦从输送导管/护套的管腔和远侧端部得到释放，环形间隔件919可以从被输送的收缩形式扩张并定位在上环形表面上，这可以将假体瓣膜和小叶905与上环形表面间隔开。接下来，假体瓣膜装置(如本文中描述的，并且可以或可以不包括如图7A中的帆908)从输送导管/护套得到输送，并且在位置上扩张以与先前定位的间隔件919连接。
我们接下来描述图9A-9D中的位置定向输送结构。通常地，这些假体带瓣装置中的每个被设计成用于左心房，并且利用左心耳(LAA)作为定向机构。图9A因此包括设置在输送护套1004的管腔内的收缩的装置100的侧表面上的左心耳插塞1006，并且在图9B中，左心耳插塞1006至少部分地定位在左心耳内。一旦左心耳被左心耳插塞1006接合，操作者就确认带瓣假体装置1000处于正确位置。该装置可以与任何先前描述的装置和方法结合使用，包括但不限于分阶段的两步输送装置和方法，其中初始定位扩张将导致左心耳插塞定向到左心耳中，然后通过从输送护套的远侧端部释放而开启装置的其余部分的二次定位扩张。
图9A和9B的某些实施例的附加益处是可以采用左心耳插塞1006作为防止左心耳内凝血的装置，其中左心耳插塞1006完全填充左心耳和/或外凸缘1008完全覆盖左心耳开口，以防止任何血凝块形成和/或移出心脏而潜在地引起中风。
图9D示出了稍微不同的机构，其中引导线1020被设置穿过输送护套1004并进入左心耳中，以为输送护套1004的管腔内的收缩的假体带瓣装置(未示出)的定位扩张(一步或分阶段)提供定向引导。护套1004可以被拉回以从护套1004的远侧端部部署/释放带瓣装置(未示出)以用于定位扩张，或者可以如前所述使用推杆来将带瓣装置推出护套的远侧端部。在这些情况下，定位在左心耳内的引导线1020提供关键定向引导参数，使得操作者知晓定位将在扩张时是适当的。引导线1020可以包括无创末端，以防止损坏左心耳的组织。
图9C示出了另一对准/定向系统，其中输送导管/护套1004经由肺静脉PV(例如上肺静脉)引入左心房中，并且引导线1020设置成穿过输送导管/护套1004的管腔并进入或接近瓣环(即，环形喉部)，作为用于待输送的带瓣装置(未示出，但如前面所述呈压缩和自扩张态)的引导件。当护套1004被拉回或者推杆被用于将收缩的带瓣装置推出输送导管或护套1004的远侧端部时，扩张中的带瓣装置可以在预定位的引导线1020上向下滑动，以在完全扩张时到达适当位置。
图10A示出了从输送导管护套释放的部分扩张的支架式带瓣装置1100。示出了至少一根捕获线1030(示出为径向包绕着装置1100，但可以采用其它包绕位置)，并且其限制可扩张装置1100完全扩张，直到适当地定位在对象心脏腔室(例如左心房)内。当适当位置得到确认时，捕获线1030可以被移除，即通过切割并穿过输送护套1004的管腔向远侧取回，或通过断开连接器引脚或闩锁1032或等同者，以允许装置1100在适当定位位置处完全扩张。图10B是类似的，具有对准线1130，其在它与部分地扩张的护套在2个或3个或更多个稳定点1034处连接着的同时进给出输送导管/护套1104的远侧端部时协助位置定向，直到适当位置得到确认。稳定点1134连接可以将部分扩张的装置保持在该状态直到适当位置得到确认，然后连接可以被移除，即通过切割(如在可释放缝合线的情况中那样)或通过断开连接器引脚或闩锁，以允许在适当定位位置处完全扩张，或者通过提供二次线上切割器，其经由输送导管/护套1104引入以剪断对准线1130。
图10C提供了一替代性假体心脏瓣膜装置，其示出为在从输送导管/护套1104的远侧端部释放之后处于位置上的扩张位置，并且包括位于支架式心脏瓣膜装置内的至少一个附接点1032以及两个或更多个拉/推线1130，其具有连接到至少一个附接点1032的第一端部以及附接到围绕支架框架的点1033的第二端部。该配置可以通过数种不同的方式起作用，以促进重新捕获、重新定位和/或重新部署。
首先，一个实施例可以包括两个或更多个拉/推线1130，其长度略小于腔室(例如左心房)尺寸以确保适当定位。一旦位置被确认为适当，拉/推线1130就可以被释放，例如通过二次线上切割器或其它器件来解除至少一个附接点1032与两个或更多个拉/推线1130之间的拉/推线连接，从而允许适当定位的框架在腔室内的完全扩张。与本文中描述的其它实施例一样，完全扩张的框架可以略大于至少一个尺寸以便于锚定。
另一实施例可以进一步包括推杆，其平移地设置在输送导管/护套1104的管腔内，并且其还提供向远侧延伸的可释放连接器，该连接器附接至支架式心脏瓣膜框架内的至少一个附接点1032，以便在适当定位得到确认后，解除至少一个附接点1032与两个或更多个推/拉线1130之间的附接。该实施例提供了进一步的益处，即使用向远侧延伸的可释放连接器工具来在至少一个附接点上向近侧拉动，其中附接点和推/拉线连接至支架框架上的点，这在向近侧的力被施加到附接点时，导致支架框架略微或完全收缩，以允许重新定位。一旦得以重新定位，则向远侧的力被施加到可释放连接器工具，以使假体瓣膜框架完全扩张。
仍另一实施例可以包括附接点1132、推/拉线1130、和/或推/拉线到支架框架的连接由在一短时间周期内溶解的材料形成。
图11示出了假体瓣膜装置1200，其包括支撑框架(窝或部分窝)与设置在其中的假体瓣膜和小叶1253(球或部分球)之间的球窝关系。在该实施例中，外框架1250如图所示是具有圆角和中心点1252的部分球体，且中心点1252大体围绕原生瓣膜和瓣环设置。外框架1250可以包括径向延伸的凸缘1254以与上环形表面连接和密封，并且可以进一步包括壁元件1256，其从径向延伸的凸缘1254的至少一些部分向上延，以与腔室(例如左心房)壁连接并抵靠其密封。径向延伸的凸缘1254可以包括可扩张的支架状构造，以提供径向扩张力来协助锚定该装置1200。替代构造可以包括本文中描述的假体支架瓣膜框架中的任一个，例如且不限于，上部开放式可扩张框架与被组织覆盖的下部可扩张框架。
假体瓣膜进一步包括内部的部分球体1253，其具有与外框架的部分球体1250的圆角匹配或互补的圆角，但是具有比外框架1250更小的半径，因为内部的部分球体1253驻留在外框架的部分球体1250内。假体小叶被支撑在内部的部分球体1253内。内部的部分球体1253可以包括与外框架的部分球体1250的摩擦配合，使得一些移动在所有维度中都是可行的(包括旋转)，而不会失去相对于原生瓣膜和/或瓣环的适当瓣膜位置。替代方案可以允许更宽松的摩擦配合，使得内部的部分球体实质上漂浮在外框架的部分球体内，从而允许比更紧密的摩擦配合更充分的运动范围。
图12示出了一种植入物框架，附接于其上的假体瓣膜装置1300经由连接器元件1302连接至套索结构1304，其进而与操控线可操作地连接，所述操控线可以包括单根线或两根线，其向近侧延伸到操作者，该操作者于是能够操控套索1304和连接器元件1302。套索结构1304可以包括与连接器元件1302操作连接的两根远侧线W1、W2或多于两根的远侧线。如果操控线包括两根线W1、W2，则两根线中的第一根可以与线1连接，并且两根线中的第二根可以与线1连接。通过操作者拉动操控线W1、W2中的一根或两根，可以使线W1、W2与连接器元件1302断开。套索结构1304可以如图所示可扩张到大于导管1305的管腔的内径的直径，并且设置成穿过植入物框架结构，其中与套索1304和装置框架1300操作连接的连接器元件1302大体上处于植入物结构的中部。该构造允许操作者在部署期间以套索结构1304操控装置1300，并且如有必要还允许取回到导管1305的管腔中。连接器元件1302可以与装置1300的框架结构一起构造，以允许装置1300的框架结构收缩，从而允许装置1300的结构被拉回到导管1305的管腔中。连接器元件1302也可以通过操作者从装置1300的框架断开，由此线W1、W2中的一根或两根被断开，并且套索结构1304向近侧穿过导管1305撤回。在其它实施例中，当操作者将线W1、W2与连接器元件1302断开并将套索结构1304向近侧拉动穿过导管护套1305时，连接器元件1302可以保持附接至装置1300的框架结构。
如本文中给出的各种发明、其实施例及应用的描述是说明性的，而并不旨在限制本发明的范围。各个实施例的特征可以在这些发明的构思内与其它实施例组合。本文中公开的实施例的变型和修改是可能的，并且本领域技术人员在研究本专利文件后将理解实施例的各种要素的实际替代方案和等同方案。本文中公开的实施例的这些和其它变型和修改可以被做出，而不背离本发明的范围和精神。

Claims (19)

1.一种假体二尖瓣膜装置，适于在将所述假体二尖瓣膜装置输送到患者心脏的左心房内的植入部位的方法中使用，包括：
自扩张假体二尖瓣膜框架；和
假体二尖瓣膜，其包括假体二尖瓣膜小叶；
其中，所述方法包括：
利用输送导管进入左心房，所述输送导管具有近侧端部、远侧端部以及穿过其中的管腔；
将处于收缩构造的自扩张假体二尖瓣膜框架在所述输送导管的近侧端部处装载到所述输送导管的管腔中，其中自扩张假体二尖瓣膜框架的收缩构造包括附接到其上的所述假体二尖瓣膜；
将收缩的自扩张假体二尖瓣膜框架输送出输送导管的远侧端部，并进入左心房中处于接近植入部位的位置处；
允许已输送的自扩张假体二尖瓣膜框架在左心房内在植入部位处扩张，其中已扩张的自扩张假体二尖瓣膜框架的至少一部分接合左心房内的上环形表面的至少一部分；
在已输送的自扩张假体二尖瓣膜框架被允许在左心房内扩张之前，确保左心室、上环形表面下方或下游的环形组织以及心脏的原生二尖瓣膜小叶在自扩张假体二尖瓣膜框架的输送中在任何点处都不被接触；
提供附接至收缩的自扩张假体二尖瓣膜框架的侧部的插塞；
将所述插塞与左心耳对准；
当自扩张假体二尖瓣膜框架已扩张时，使左心耳与所述插塞接合，
其中所述插塞进一步包括凸缘，其围绕左心耳接合并密封心房壁。
2.根据权利要求1所述的假体二尖瓣膜装置，其中，收缩的自扩张假体二尖瓣膜框架进一步包括近侧部分和远侧部分，其中假体二尖瓣膜小叶设置在所述远侧部分内；所述方法进一步包括：将内护套装载到导管管腔中，所述内护套具有构造成与收缩的自扩张假体二尖瓣膜框架接合的远侧端部，其中所述内护套穿过所述导管管腔的平移导致收缩的自扩张假体二尖瓣膜框架平移穿过所述导管管腔。
3.根据权利要求2所述的假体二尖瓣膜装置，其中，所述内护套包括穿过其中的管腔，所述管腔定尺寸为接收收缩的自扩张假体二尖瓣膜框架的近侧部分。
4.根据权利要求3所述的假体二尖瓣膜装置，其中，所述内护套的远侧端部构造成在所述远侧部分不被接收在所述内护套的管腔内时接合收缩的自扩张假体二尖瓣膜框架的远侧部分。
5.根据权利要求2所述的假体二尖瓣膜装置，其中，输送已收缩的自扩张假体二尖瓣膜框架以及允许已输送的自扩张假体二尖瓣膜框架扩张包括：输送自扩张假体二尖瓣膜框架的远侧部分，将自扩张假体二尖瓣膜框架的远侧部分定位在植入部位附近，以及允许自扩张假体二尖瓣膜框架的已输送的远侧部分在输送已收缩的自扩张假体二尖瓣膜框架的近侧部分之前扩张，并且允许自扩张假体二尖瓣膜框架的近侧部分扩张。
6.根据权利要求1所述的假体二尖瓣膜装置，其中，所述方法进一步包括：
提供连接至收缩的假体二尖瓣膜框架的推杆；以及
利用所述推杆推动收缩的假体二尖瓣膜框架穿过所述输送导管的管腔，以在左心房内输送和扩张。
7.根据权利要求6所述的假体二尖瓣膜装置，其中，所述方法进一步包括：通过在所述推杆上向近侧拉动，使已扩张的假体二尖瓣膜框架至少部分地收缩在所述输送导管的管腔内。
8.根据权利要求6所述的假体二尖瓣膜装置，其中，所述方法进一步包括：
使定位元件平移穿过所述导管的管腔；
使自扩张假体二尖瓣膜框架的开放框架部分与所述定位元件接合；以及
在将自扩张假体二尖瓣膜框架输送到左心房中之前，使左上肺静脉的管腔与所述定位元件的远侧端部接合。
9.根据权利要求8所述的假体二尖瓣膜装置，其中，所述定位元件延伸穿过假体二尖瓣膜框架的开放框架部段。
10.根据权利要求2所述的假体二尖瓣膜装置，其中，自扩张假体二尖瓣膜框架进一步包括中央部分，其设置在所述近侧部分与所述远侧部分之间，所述中央部分具有小于所述近侧部分的最大直径和所述远侧部分的最大直径的最大直径。
11.根据权利要求10所述的假体二尖瓣膜装置，其中，所述方法进一步包括：
在自扩张假体二尖瓣膜框架的所述中央部分上提供铰接部；
将所述中央部分输送出输送导管管腔的远侧端部，以使所述铰接部暴露于左心房；以及
使所述远侧部分朝向左心房的上环形表面旋转；以及
将所述近侧部分输送出输送导管管腔的远侧端部并进入左心房中。
12.根据权利要求2所述的假体二尖瓣膜装置，其中，所述方法进一步包括：
平移通过所述输送导管的管腔设置的对准线；
使自扩张假体二尖瓣膜框架的开放框架部分与所述对准线接合；以及
在将假体二尖瓣膜装置沿着所述对准线输送到左心房中之前，使左上肺静脉与所述对准线接合。
13.根据权利要求1所述的假体二尖瓣膜装置，进一步包括至少一根捕获线，其延伸穿过输送导管管腔并与自扩张假体二尖瓣膜框架接合，适于将该框架的扩张限制为部分扩张构造。
14.根据权利要求13所述的假体二尖瓣膜装置，进一步包括：所述至少一根捕获线进一步适于通过在所述输送导管的近侧端部处操控所述至少一根捕获线来在位置上定向已部分扩张的假体二尖瓣膜框架。
15.根据权利要求14所述的假体二尖瓣膜装置，其中，所述方法进一步包括：
在左心房内在位置上定向已部分扩张的假体二尖瓣膜框架；
确认已部分扩张的假体二尖瓣膜框架的适当定向；
移除所述至少一根捕获线；以及
允许已部分扩张的假体二尖瓣膜框架完全扩张。
16.根据权利要求15所述的假体二尖瓣膜装置，其中，所述方法进一步包括：提供穿过所述输送导管的管腔的推/拉杆，其适于协助在位置上定向已部分扩张的假体二尖瓣膜框架。
17.根据权利要求1所述的假体二尖瓣膜装置，进一步包括附接至假体二尖瓣膜框架的套索元件，其适于在所述输送导管的近侧端部处被操控；所述方法进一步包括：操控所述套索元件以在位置上定向、防止假体二尖瓣膜框架的完全扩张和/或允许假体二尖瓣膜框架在左心房内完全扩张。
18.根据权利要求1所述的假体二尖瓣膜装置，其中，自扩张假体二尖瓣膜框架进一步包括由支架形成的上部，其包括至少两组相对的子部，所述相对的子部中的一组包括织物覆盖物。
19.根据权利要求18所述的假体二尖瓣膜装置，其中，所述方法进一步包括：使用所述织物覆盖物来捕获血液流动，以定位自扩张假体二尖瓣膜框架并使已定位的自扩张假体二尖瓣膜框架扩张。
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