CN110225728A - 用于假体心脏瓣膜的两步式输送和植入的系统、方法和装置 - Google Patents

用于假体心脏瓣膜的两步式输送和植入的系统、方法和装置 Download PDF

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CN110225728A
CN110225728A CN201880008124.0A CN201880008124A CN110225728A CN 110225728 A CN110225728 A CN 110225728A CN 201880008124 A CN201880008124 A CN 201880008124A CN 110225728 A CN110225728 A CN 110225728A
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mitral valve
prosthetic
valve film
prosthetic mitral
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CN110225728B (zh
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杰弗里·W·钱伯斯
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4C Medical Technologies 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or 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
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Abstract

公开了两步式输送方法、系统和装置，在各种实施例中包括自扩张框架。自扩张框架被输送在心脏腔室内并在其内扩张，随后将在其上包括有假体瓣膜的假体瓣膜输送到已扩张的自扩张框架中，其进而连接至在已输送且已扩张的框架上并由其限定的瓣膜连接区域。

Description

用于假体心脏瓣膜的两步式输送和植入的系统、方法和装置
发明人
Jeffrey W.Chambers，居住在梅普尔格罗夫，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24日提交且题为“SYSTEMS,METHODS AND DEVICES FOR ATRIALANCHORING FRAME AND CONNECTIVE VALVE SYSTEM AND TWO-STEP IMPLANTATION METHOD”的美国临时申请序列号No.62/449713的权益。
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、主动脉瓣膜和肺动脉瓣膜。
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，而主动脉瓣膜和肺动脉瓣膜是位于供血液流动离开心脏的动脉中的半月瓣膜。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。
附图说明
图1示出了本发明的一个实施例的侧剖视图。
图2示出了本发明的一个实施例的侧剖视图。
图3示出了本发明的一个实施例的侧剖视图。
具体实施方式
图1示出了两部分式假体瓣膜装置100的一部分的一个实施例，包括偏置以扩张的可收缩左心房自扩张框架102以及在其上附接有假体小叶处于偏置扩张构造中的可收缩假体二尖瓣膜104，其继自扩张框架102之后被输送，且在输送之后进一步连接至自扩张框架102。
当在左心房内已扩张时，自扩张框架102的锚定构件的远侧部分的至少一部分例如下部可以定位抵靠左心房内的瓣环的上表面，如图所示。如图所示，已扩张的框架102包括开口，其由周向(或其它成形)区域限定，其将用于连接至假体瓣膜的第二部分，可收缩且可扩张的瓣膜。该区域被定义为假体瓣膜或假体二尖瓣膜连接区域106，并且可以包括线或其它结构，以便于与后来输送的假体瓣膜连接。
因此，图1的构造在其各种实施例中允许通过两步式框架定位扩张方法来输送框架102，其对于腔室(例如左心房)尺寸可以略微过大。注意，所示已扩张的框架/锚定构件102的成形轮廓大致呈现心房腔室本身的成形，且实质上接触壁、内顶和瓣环的上表面(超环形表面)，其限定左心房的基底的至少一部分，并且因此如本文中所描述的，上环形表面位于左心房内。自扩张假体瓣膜框架(即，自扩张假体二尖瓣膜框架)102在扩张之后的替代形式和形状也可以被使用，并且处于本发明的范围内，只要扩张的框架用于将假体瓣膜锚定在心房腔室内即可。应该明白的是，由于解剖约束和阻力，已扩张框架102可以包括未变形的形状或轮廓，其不同于已扩张和植入的形状或轮廓。
如图2中所示，可以使用经中隔导管输送技术来将收缩的框架102输送到心房，这种经导管输送技术是本领域的技术人员众所周知的。如本领域的技术人员将容易理解的，向心脏腔室(例如左心房)的其它公知类型的经皮进入可以与所公开的输送方法和结构结合使用。例如，经心尖进入、经股进入、经心房进入和经中隔进入。当通过公知技术将收缩的框架102推动超过输送导管108的远侧开口时，框架102被偏置以扩张并因此在从输送导管108释放后扩张。框架102可以被输送，使得瓣膜连接区域106定位成接合超环形表面，并在框架102扩张时允许左心房、瓣环和左心室之间的持续流体接合。
现在转到图2，自扩张框架102被定位为在心房腔室内扩张并锚定，且二尖瓣膜连接区域102大体上位于瓣环上方，以在假体二尖瓣膜104(包括附接于其上的假体二尖瓣膜小叶)被输送和连接时允许流体流动穿过其中。
在自扩张假体二尖瓣膜框架102的定位扩张和锚定之后，可收缩且可扩张的假体二尖瓣膜104被输送穿过导管的管腔，所述导管延伸穿过导管框架中的间隙并进入心房腔室中。一旦假体二尖瓣膜104平移超过导管108的远侧开口，瓣膜104就扩张到其偏置扩张构造。如图所示，系绳线110或其它器件可以用于进一步向下定位已输送的假体二尖瓣膜104，以与框架102上的假体二尖瓣膜连接区域106连接。这种连接可以用卡入定位机构形成，比如在已扩张瓣膜104的下表面或瓣膜连接区域上的阳性构件，其与假体二尖瓣膜连接区域106的对应部分上的互补阴性构件连接。例如，假体二尖瓣膜连接区域106可以包括可以包括阳性构件，其与已输送的假体二尖瓣膜104的下表面上的阴性构件连接。替代地，假体二尖瓣膜连接区域106可以包括阴性构件，其与已输送的假体二尖瓣膜104的下表面上的阳性构件连接。一旦形成连接，该连接实施例可以包括锁定机构。
替代地，假体瓣膜的两个部件即已扩张的框架102和已输送的瓣膜104可以通过扎带式连接件来连接，其中瓣膜104可以锁定就位并进一步向下移动到框架102中，以允许瓣膜高度的变化，和/或如有需要在假体二尖瓣膜104的输送和连接期间，使它移动更靠近原生二尖瓣膜。
图3示出了假体瓣膜装置100的一个实施例，其由已输送且已扩张的假体二尖瓣膜框架102和已连接的假体二尖瓣膜104构成。优选实施例包括定位和/或完全间隔在上环形表面上方的假体二尖瓣膜104。替代地，本发明还可以包括与上环形表面处于共线位置的假体二尖瓣膜102，或假体二尖瓣膜102可以定位在上环形表面下方，使得假体二尖瓣膜102的至少一部分位于在瓣环内。
作为结果，各种构造对于上述实施例都是可行的。
如以上描述的两步假体瓣膜装置可以被提供来置换和/或修补现有的原生心脏瓣膜，例如二尖瓣膜或三尖瓣膜。在提供修补的实施例中，原生瓣膜被允许在已植入的假体瓣膜装置的接合或干扰最小或没有的情况下继续工作。此外，当原生瓣膜功能充分恶化时，则已植入的假体瓣膜装置可以承担全部功能并完全取代原生瓣膜的功能。因此，通过单个程序和植入物实现了对原生瓣膜功能的修补和最终置换。
某些实施例包括已输送的假体二尖瓣膜装置100，其不接触、接合和/或干扰左心室、左心房与左心室之间的瓣环内的组织(也称为环形组织，位于形成左心房的基底的至少一部分的上环形表面下方)和/或原生二尖瓣膜小叶中的至少一个。通过使已扩张的假体装置100位于上环形表面之上或上方，可以至少部分地实现这些特性。此外，假体二尖瓣膜104和/或假体二尖瓣膜连接区域106可以位于原生二尖瓣膜之上或上方，即与原生二尖瓣膜间隔开。
在其它实施例中，已输送且扩张的假体二尖瓣膜装置100、以及假体二尖瓣膜和/或假体二尖瓣膜连接区域104、106可以定位成不低于上环形表面。本领域的技术人员将认识到，在一些情况下，该布置可以部分地接合原生瓣膜小叶，为原生小叶在它们向上移动以对合时提供停止点，从而为原生小叶建立固定且人造的对合点，以协助尽可能长时间地保持和维持原生瓣膜小叶功能。因此，假体二尖瓣膜连接区域、与假体二尖瓣膜连接区域106连接的假体瓣膜104和/或假体二尖瓣膜小叶可以位于上环形表面之上。
在其它实施例中，已扩张的假体装置100的一部分可以向下延伸到瓣环中，并且可以接合或接触左心室、上环形表面下方的环形组织和/或原生二尖瓣膜小叶中的至少一个。
根据向心脏腔室(例如左心房)经皮进入的类型，例如经心尖进入、经股进入、经心房进入和经中隔进入，假体心脏瓣膜装置100及其部件的输送可以或可以不接合或接触左心室、上环形表面下方的环形组织和/或原生二尖瓣膜小叶中的一个。
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 (33)

1.一种将包括假体二尖瓣膜小叶的自扩张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以修补和/或替换原生二尖瓣膜小叶功能的两步式方法，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输送导管的近侧端部处装载到输送导管的管腔中，其中假体二尖瓣膜装置的收缩构造包括：
附接于其上的假体二尖瓣膜连接区域；以及
具有穿过其中的开口的部段；
将收缩的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，其中已扩张的装置的至少一部分接合左心房内的上环形表面的至少一部分，并且其中假体二尖瓣膜连接区域与左心房和左心室之间的瓣环大致对准；
将包括假体二尖瓣膜小叶的假体二尖瓣膜装载到输送导管的管腔中，并将假体二尖瓣膜输送出输送导管的远侧端部并进入已扩张的自扩张假体二尖瓣膜框架中；以及
定位并连接假体二尖瓣膜到已扩张的假体瓣膜框架的假体二尖瓣膜连接区域。
2.根据权利要求1所述的方法，进一步包括提供附接至假体二尖瓣膜的至少一根系绳线，以协助将假体二尖瓣膜输送、定位并连接至假体二尖瓣膜连接区域，所述至少一根系绳线由操作者可操作地操控。
3.根据权利要求1所述的方法，进一步包括将自扩张假体二尖瓣膜框架定尺寸为在自扩张假体瓣膜框架被允许在没有阻力的情况下实现未变形扩张构造时，实现比左心房的宽度和/或高度更大的宽度和/或高度。
4.根据权利要求1所述的方法，进一步包括将收缩且自扩张的假体二尖瓣膜装载到输送导管中，其中假体二尖瓣膜在被输送出输送导管的远侧端部并进入已扩张的自扩张假体二尖瓣膜框架中时自我扩张。
5.根据权利要求1所述的方法，进一步包括在假体二尖瓣膜被输送并连接至假体二尖瓣膜连接区域期间，增加或减小假体二尖瓣膜小叶与原生二尖瓣膜小叶的间隔。
6.根据权利要求1所述的方法，进一步包括通过由以下途径组成的组中的方法之一经皮地进入心脏腔室：经心尖进入、经股进入、经心房进入和经中隔进入。
7.根据权利要求1所述的方法，其中，已扩张的假体二尖瓣膜装置接合左心房内的上环形表面的至少一部分。
8.根据权利要求1所述的方法，其中，已扩张的假体二尖瓣膜框架接合左心房内的上环形表面的至少一部分。
9.根据权利要求1所述的方法，进一步包括确保在假体二尖瓣膜装置的输送和扩张期间在任何点处都不接触左心室。
10.根据权利要求1所述的方法，进一步包括确保在假体二尖瓣膜的输送期间在任何点处都不接触左心室。
11.根据权利要求1所述的方法，进一步包括确保在将假体二尖瓣膜连接至假体二尖瓣膜连接区域期间在任何点处都不接触左心室。
12.根据权利要求1所述的方法，进一步包括确保上环形表面下方和下游的环形组织在任何点处都不被已扩张的假体二尖瓣膜装置接触。
13.根据权利要求1所述的方法，进一步包括确保上环形表面下方和下游的环形组织在任何点处都不被假体二尖瓣膜框架的输送接触。
14.根据权利要求1所述的方法，进一步包括确保上环形表面下方和下游的环形组织在任何点处都不被假体二尖瓣膜向假体二尖瓣膜连接区域的输送或连接所接触。
15.根据权利要求1所述的方法，进一步包括确保原生二尖瓣膜小叶不被假体二尖瓣膜装置的输送和扩张所接触。
16.根据权利要求1所述的方法，进一步包括确保原生二尖瓣膜小叶不被已输送且已扩张的假体二尖瓣膜连接区域接触。
17.根据权利要求1所述的方法，进一步包括确保原生二尖瓣膜小叶不被已输送且已连接的假体二尖瓣膜接触。
18.根据权利要求1所述的方法，进一步包括确保已连接的假体二尖瓣膜位于左心房的上环形表面上方。
19.根据权利要求1所述的方法，进一步包括确保已连接的假体二尖瓣膜的至少一部分位于左心房的上环形表面下方。
20.根据权利要求1所述的方法，其中，在将假体二尖瓣膜连接至假体二尖瓣膜框架之后，假体二尖瓣膜小叶间隔在原生二尖瓣膜小叶上方并远离原生二尖瓣膜小叶。
21.根据权利要求1所述的方法，进一步包括将已输送且已扩张的二尖瓣膜框架的假体二尖瓣膜连接区域间隔在原生二尖瓣膜小叶上方且远离原生二尖瓣膜小叶。
22.根据权利要求1所述的方法，进一步包括将已输送且已扩张的二尖瓣膜框架的假体二尖瓣膜连接区域间隔在左心房内的上环形表面上方并远离该上环形表面。
23.根据权利要求1所述的方法，进一步包括使已输送且已扩张的二尖瓣膜框架的假体二尖瓣膜连接区域位于左心房内的上环形表面上。
24.根据权利要求1所述的方法，进一步包括使已输送且已扩张的二尖瓣膜框架的假体二尖瓣膜连接区域至少部分地位于瓣环内，其中假体二尖瓣膜连接区域的至少一部分位于上环形表面下方。
25.根据权利要求1所述的方法，进一步包括假体二尖瓣膜在输送并连接至假体二尖瓣膜连接区域之后至少部分地位于瓣环内，其中假体二尖瓣膜的至少一部分位于上环形表面下方。
26.根据权利要求1所述的方法，进一步包括在将假体二尖瓣膜输送并连接至假体二尖瓣膜连接区域之后使假体二尖瓣膜小叶位于瓣环内，其中假体二尖瓣膜小叶位于上环形表面下方。
27.根据权利要求1所述的方法，包括确保已输送且已扩张的假体二尖装置的至少一部分位于一点处，其中已输送且已扩张的二尖装置的至少一部分接触原生二尖瓣膜小叶。
28.根据权利要求1所述的方法，进一步包括在假体二尖瓣膜装置的输送和/或扩张期间，接触心室、位于上环形表面下方的环形组织和原生二尖瓣膜小叶中的至少一个。
29.一种将包括假体瓣膜小叶的自扩张假体瓣膜装置输送到患者心脏腔室内的植入部位以便修补和/或置换原生瓣膜的两步式方法，包括：
利用输送导管进入心脏腔室，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瓣膜框架在输送导管的近侧端部处装载到输送导管的管腔中，其中假体二尖瓣膜装置的收缩构造包括：
附接于其上的假体瓣膜连接区域；以及
具有穿过其中的开口的部段；
将收缩的假体瓣膜框架输送出输送导管的远侧端部，并进入心脏腔室中处于接近植入部位的位置处；
允许已输送的自扩张假体瓣膜框架在心脏腔室内在植入部位处扩张，其中已扩张的装置的至少一部分接合心脏腔室的组织的至少一部分；
将假体瓣膜装载到输送导管的管腔中，并将假体瓣膜输送出输送导管的远侧端部并进入已扩张的自扩张假体瓣膜框架中；以及
连接假体瓣膜到已扩张的假体瓣膜框架的假体瓣膜连接区域。
30.根据权利要求29所述的方法，进一步包括：将自扩张假体瓣膜定尺寸为在自扩张假体瓣膜框架被允许在没有阻力的情况下完全扩张时，实现比心脏腔室的宽度和/或高度更大的宽度和/或高度。
31.根据权利要求29所述的方法，其中，假体瓣膜通过瓣膜框架中的开口之一输送到已扩张的自扩张假体瓣膜框架中。
32.根据权利要求29所述的方法，进一步包括：将收缩且自扩张的假体瓣膜装载到输送导管中，其中假体瓣膜在被输送出输送导管的远侧端部并进入已扩张的自扩张假体瓣膜框架中时自我扩张。
33.根据权利要求29所述的方法，进一步包括：通过由以下途径组成的组中的一个经皮地进入心脏腔室：经心尖进入、经股进入、经心房进入和经中隔进入。
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