CN101056596B - 用于治疗心脏瓣膜反流的装置和方法 - Google Patents

用于治疗心脏瓣膜反流的装置和方法 Download PDF

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CN101056596B
CN101056596B CN2005800386720A CN200580038672A CN101056596B CN 101056596 B CN101056596 B CN 101056596B CN 2005800386720 A CN2005800386720 A CN 2005800386720A CN 200580038672 A CN200580038672 A CN 200580038672A CN 101056596 B CN101056596 B CN 101056596B
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CN101056596A (zh
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A·扎凯
D·罗藤伯格
D·米沙利
D·阿伦
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Edwards Lifesciences AG
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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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • 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
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
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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
    • 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
    • A61F2210/0066—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof shrinkable

Abstract

在一个实施例中，本发明提供了可以植入在心脏内以至少部分地阻塞可能位于两个二尖瓣小叶之间的间隙的假体。在一个优选实施例中，假体包括在左心房内扩张以锚定假体的锚定圈和固定到锚定圈的袋部件。袋部件定位在二尖瓣内，在小叶之间，从而使袋部件的开放端定位在左心室内。当二尖瓣开放的时候，血液流过袋部件，使袋部件维持在塌陷状态下。当二尖瓣闭合的时候，血液的反压推动到袋部件内，使袋部件扩张到膨胀的形状。二尖瓣小叶接触扩张的袋部件，允许假体阻塞在小叶之间的开口的至少部分，由此使反流的血流进到左心房内最小。

Description

用于治疗心脏瓣膜反流的装置和方法
                        相关申请
本申请要求对序列号为60/609,345的于2004年9月14日提出的题目为“Device and Method for Reducing Mitral Valve Regurgitation”的美国临时申请和序列号为60/657,919的于2005年3月3日提出的题目为“Device and Method for Reducing Mitral Valve Regurgitation”的美国临时申请的优先权；在这里，这两项申请都通过参考予以合并。
背景技术
二尖瓣是人心脏的最至关重要的四个瓣膜中的一个，防止血液在心脏收缩期间从左心室反流到左心房内。位于左心房和左心室之间，二尖瓣包括两个定位成在闭合状态下阻塞血液流动而在开放状态下允许血液流动的小叶。
通过在左心房和左心室之间的压力差，并且通过由从二尖瓣小叶的自由边缘延伸到在心脏的心室壁上的乳头肌的胶原绳状结构即所谓的腱索组成的复杂网络，二尖瓣开放和闭合。当乳头肌收缩的时候，它们拉动小叶，由此使二尖瓣开放，允许血液流动到左心室内。当乳头肌松弛的时候，在小叶上的拉力减小，使二尖瓣闭合，由此阻塞血液流动到左心室内。
当瓣膜小叶不能接合或完全闭合的时候，二尖瓣的正常操作可能受到损害，允许反流的血液流回到左心房内。引起这种二尖瓣反流的常见原因是先天性瓣膜缺陷或心脏几何形状由于疾病发生变化。例如，感染可能使二尖瓣环变大，由此使瓣膜小叶的位置和取向发生变化。在另一个例子中，二尖瓣缺陷可能使小叶脱垂或不匹配，允许血流反流回左心房。
一种治疗不全的二尖瓣的先前的办法包括以手术方式用人造瓣膜进行替换。在这些措施中，典型地，对患者进行开心手术，以用机械或生物来源的瓣膜替换不健全的瓣膜。尽管随着时间过去这种治疗措施得以改进，但大量限制仍然存在。例如，对二尖瓣进行移除和替换具有很大的侵入性，因此大大增加了出现严重并发症例如感染或排斥的风险。
其它手术技术得以发展，以减小必需用瓣膜替换方法对心脏进行再造的量。一种这样的技术已知为蝴蝶结修补，在其中，每个二尖瓣小叶的中心区域都缝合在一起。另一种技术包括形成围绕瓣膜环的安抚件，由此减小瓣膜环的截面面积。尽管与瓣膜替换方法相比，这些技术需要进行较少再造，但仍然需要进行相当大量再造。此外，在手术结束之前，对手术措施的效力进行评估可能是困难的。
在又一种技术中，瓣环成形圈缝在二尖瓣的环内。由于环形成圈的直径小于二尖瓣环的直径，所以瓣膜的小叶移动到一起，增加接合。除了也具有很大的侵入性之外，环形成圈通常使二尖瓣的自然弯曲的形状发生扭曲，并且还可能限制环的收缩性。
尽管以上所描述的技术在治疗二尖瓣缺陷方面取得了一些成功，但要求对心脏进行少的再造或不需要对心脏进行任何再造的额外的治疗措施是需要的。此外，可以在侵入性最小化的情况下进行但还可以更有效地减小或消除二尖瓣反流的额外的治疗是需要的。
发明目的和内容
本发明的目的是克服现有技术的限制。
本发明的目的是提供用于治疗二尖瓣反流的改进的方法和装置。
本发明的另一个目的是提供减小血液反流到左心房内的假体装置。
本发明的又一个目的是提供可以经皮递送并且在患者体内展开的假体装置。
本发明的另一个目的是提供可以动态地对在二尖瓣小叶之间的间隙进行填充的假体装置。
本发明的另一个目的是提供可以减小二尖瓣反流的大多数病理状况的假体装置。
通过提供可以植入在心脏内以至少部分地使可能位于两个二尖瓣小叶之间的间隙阻塞的假体，本发明试图达到这些目的及在此没有明确列举的其它目的。在一个优选实施例中，假体包括在左心房内扩张以锚定假体的锚定圈和固定到锚定圈的袋部件。袋部件定位在二尖瓣内，在小叶之间，从而使袋部件的开放侧定位在左心室内。当二尖瓣开放的时候，血液流过袋部件，使袋部件维持在塌陷状态下。当二尖瓣闭合的时候，血液的反压推入袋部件，使袋部件扩张到膨胀的形状。二尖瓣小叶接触扩张的袋部件，允许假体阻塞在小叶之间的开口的至少部分，由此最小化反流的血流到左心房内。
本发明的另一个优选实施例提供了用于治疗瓣膜反流的装置，包括：
确定尺寸为至少部分地放置在瓣膜的小叶之间的接合部件，所述的接合部件具有扩张状态和缩小状态，并且具有大致上等于所述的小叶的连合处的长度；和
连接到所述的接合部件的锚定结构，所述的锚定结构具有确定尺寸为配合在递送导管内的压缩状态和确定尺寸为固定在邻近所述的瓣膜的腔的壁的至少部分上的扩张状态。
本发明的另一个优选实施例提供了治疗瓣膜反流的方法，包括：
将假体加载在递送导管内，所述的假体包括锚定部分和接合部分；
使所述的递送导管前进到心脏的腔；
在瓣膜内展开所述的接合部分；
使所述的锚定部分扩张，以接触所述的腔的壁；和
将所述的接合部分支撑在所述的瓣膜的连合处内。
本发明的另一个优选实施例提供了用于在心脏收缩期间大致上阻塞在瓣膜内血流的装置，包括：
具有侧向尺度的柔性部件；
连结到所述的柔性部件并且确定形状为沿着所述的瓣膜的小叶的连合处长度定位所述的柔性部件的所述的侧向尺度的支撑部件；
连结到所述的支撑部件的锚定部件，所述的锚定部件包括压缩构型和扩张构型；
在其中，所述的锚定部件的所述的扩张构型确定形状为将所述的支撑部件至少部分地定位在所述的瓣膜内。
附图说明
图1A图示了根据本发明的一个优选实施例的假体的前视图；
图1B图示了图1A的假体的透视图；
图1C图示了在扩张构型内的图1A的假体的剖面图；
图1D图示了在缩小构型内的图1A的假体的剖面图；
图2A图示了在二尖瓣内的在缩小构型内的图1A的假体的底视图；
图2B图示了在二尖瓣内的在扩张构型内的图1A的假体的底视图；
图3A图示了在二尖瓣内的在缩小构型内的图1A的假体的剖面图；
图3B图示了在二尖瓣内的在扩张构型内的图1A的假体的剖面图；
图4图示了在递送导管内的图1A的假体的前视图；
图5A图示了根据本发明的另一个优选实施例的假体的前视图；
图5B图示了图5A的假体的侧视图；
图5C图示了图5A的假体的透视图；
图5D图示了图5A的假体的透视图；
图6图示了在心脏内的图5A的假体的侧视图；
图7A和7B图示了在递送导管内的图5A的假体的侧视图；
图8A和8B图示了带有收回线的图5A的假体的侧视图；
图9A图示了根据本发明的另一个优选实施例的假体的前视图；
图9B图示了图9A的假体的侧视图；
图9C图示了图9A的假体的透视图；
图9D图示了图9A的假体的透视图；
图9E图示了在图9D中的区域9E的放大图；
图10A图示了根据本发明的另一个优选实施例的假体的前视图；
图10B-10D图示了图10A的假体的多种透视图；
图11图示了在从递送导管展开期间的图10A的假体的侧视图；
图12A图示了根据本发明的另一个优选实施例的假体的前视图；
图12B图示了图12A的假体的侧视图；
图12C-12E图示了图12A的假体的多种透视图；
图13图示了在心脏内的图12A的假体的侧视图；
图14A图示了根据本发明的另一个优选实施例的假体的前视图；
图14B图示了图14A的假体的侧视图；
图14C图示了图14A的假体的顶视图；
图14D和14E图示了图14A的假体的多种透视图；
图15图示了在心脏内的图14A的假体的侧视图；
图16A和16B图示了在递送导管内的图14A的假体的侧视图；
图17A图示了根据本发明的另一个优选实施例的假体的前视图；
图17B图示了图17A的假体的顶视图；
图17C和17D图示了图17A的假体的透视图；
图18A图示了根据本发明的另一个优选实施例的假体的前视图；
图18B和18C图示了图18A的假体的多种透视图；
图18D图示了在图18B中的区域18D的放大图；
图19A图示了根据本发明的另一个优选实施例的假体的前视图；
图19B和19C图示了图19A的假体的多种透视图；
图19D图示了在图19B中的区域19D的放大图；
图20A图示了根据本发明的另一个优选实施例的假体的前视图；
图20B和20C图示了图20A的假体的多种透视图；
图21A图示了在部分展开构型内的图20A的假体的侧视图；
图21B图示了在图21A中的区域21B的放大图；
图22A图示了根据本发明的另一个优选实施例的假体的前视图；
图22B和22C图示了图22A的假体的多种透视图；
图23A图示了根据本发明的另一个优选实施例的假体的前视图；
图23B图示了图23A的假体的顶视图；
图23C和23D图示了图20A的假体的多种透视图；
图24A图示了根据本发明的另一个优选实施例的假体的前视图；
图24B图示了图24A的假体的侧视图；
图24C和24D图示了图20A的假体的多种透视图；
图24E图示了在图24D中的区域24E的放大图；
图25图示了根据本发明的另一个优选实施例的在心脏内的假体的侧视图；
图26A图示了根据本发明的另一个优选实施例的在心脏内的假体的侧视图；和
图26B图示了图26A的假体的截面图。
具体实施方式
本发明试图减小在心脏收缩的心脏收缩期期间从左心室流动到左心房内的血液的量。这种二尖瓣反流的大多数情况由二尖瓣小叶的差接合引起，当二尖瓣闭合的时候，差接合的二尖瓣小叶在这些小叶之间形成开口。本发明减小在二尖瓣小叶之间的这些开口的尺寸，而在一些情况下，完全消除开口，允许二尖瓣在很少发生反流或不发生任何反流的情况下发挥功能。在至少一些在本说明书中所描述的作为例子的实施例中，通过将部件定位在两个二尖瓣小叶之间，以当闭合的时候，使在小叶之间的开口闭合或填充在小叶之间的开口，这得以实现。
图1A-4
在图示了根据本发明的假体100的优选实施例的图1A-4中，可以看到一种这样的设计。假体100包括由柔性材料104形成的布置在圈102上的袋106。如在图1B中所最佳看到的那样，袋106包括下部开放端106A，当在心脏124的二尖瓣120内适当地取向的时候，当二尖瓣120闭合的时候，下部开放端106A扩张，阻塞在二尖瓣小叶122之间的任何开口。此外，当二尖瓣120开放的时候，袋106收缩或缩小，使从左心房126到左心室128的血流最大化。就此而言，袋106可以更一般地描述为可扩张的闭塞部件或接合部件。
优选地，通过在线108或围绕线108将至少两层柔性材料104粘合、缝纫或用其它手段附着，袋106形成。这些层可以用两片不同的材料实现，或用靠着自身折叠的单片材料实现。优选地，柔性材料104由心包组织或带有类似柔性的其它生物或人造材料例如牛的组织、聚氨酯或如编号为6,764,510的美国专利所描述的那样的材料制造，在这里，这项专利的内容通过参考予以合并。袋106的形状和柔性织物108的柔性允许袋106如在图1D、2A和3A中所最佳看到的那样达到缩小位置，并且允许袋106如在图1C、2B和3B中所最佳看到的那样达到扩张状态。
尽管袋106可以确定形状为多种不同的构型，但有助于血液流入袋106和从袋106流出的袋形状，例如袋106的倒圆的弯弓形状是优选的。包括尖锐的角部或粗糙的接缝的袋106的构型由于它们对血流进入袋106内和从袋106出来的中断作用而不是优选的。优选地，如在图2B中所最佳看到的那样，袋106也包括类似于二尖瓣120的全长并且更优选地大致上类似于二尖瓣连合处的长度的全长，允许袋106填充可能沿着小叶122的长度存在的任何开口。尽管单个的袋106是优选的，但额外的袋或在袋内的分隔件也可以包括在本发明内。
圈102优选地由弹性的形状记忆材料，例如镍钛诺制造，这种材料允许假体100如在图4中所看到的那样压缩或加载到递送导管110内，然后如在图3A和3B中所看到的那样在左心房126内扩张到预定形状。圈102确定尺寸为压靠在心脏124的左心房126的壁上，而在一些构型内，压靠在二尖瓣120的连合处内，由此锚定假体100的位置，同时将袋106定位成至少部分地经过二尖瓣120。额外地，袋106的下部开放端106A定位在左心室128附近或定位在左心室128内。就此而言，圈102可以更一般地描述为锚定框架或锚定结构。
一旦定位在心脏124内，假体100就以类似于心脏瓣膜的方式发挥功能，在心脏舒张期间开放，而在心脏收缩期间闭合。更特殊地，当血液从在左心房126的顶部附近的肺静脉125流进左心房的时候，血流向下朝向二尖瓣120移动。当血流到达二尖瓣120的时候，当二尖瓣120通过乳头肌开放的时候，血流推靠二尖瓣小叶122。如在图3A中所看到的那样，血流也推靠假体100的袋106，使可能在袋106内的任何血液出来，并且使袋106呈现大致上缩小或压缩的位置。袋106的这种压缩构型提供了使血流阻力和在左心房内的装置可能另外引起的其它中断作用最小化的流线形轮廓。就此而言，血流在心脏舒张期间通到左心房126内，经过二尖瓣120并且经过假体100，以允许血流通到左心室128内。
在心脏收缩期间，当乳头肌使这些小叶122移动到闭合位置的时候，由来自左心室128内的血液的反压压靠在二尖瓣小叶122上。额外地，在左心室128内的血液的该反压进入到假体100的袋106内，使袋106如在图3B中所看到的那样达到扩张形状。二尖瓣小叶124如在图2B中所最佳看到的那样接合靠在扩张的袋106上，使可能另外位于两个小叶122之间的间隙最小化，或甚至消除这些间隙。因而，在心脏收缩期间的血流使假体100扩张，以减小或消除可能另外位于小叶122之间的任何开口，最终减小或防止血液反流到左心房126内。
部分地由于袋106的动态的柔性的特性，假体100可以在不需要等大范围的袋尺寸的情况下，扩张成填充在小叶122之间的大范围的开口尺寸。换言之，相同尺寸的袋106可以扩张成填充在二尖瓣小叶122之间的相对小的开口或相对大的开口。因而，相同尺寸的假体100可以适合于患有相对严重的二尖瓣反流及相对轻缓的二尖瓣反流的患者。然而，不同尺寸的假体100可以适合于不同尺寸的二尖瓣120，因为优选的是，袋106沿着二尖瓣的连合处的长度或在两个小叶之间的“会合线”的长度延伸。
如在图4中所看到的那样，假体100优选地通过导管110经皮递送到左心房126。例如，递送导管110可以经过股静脉供给到右心房内，并且经过在心房隔膜125内的预制的穿孔。在另一个例子中，递送导管110可以经过股动脉而进到主动脉内，经过主动脉瓣膜并且进到左心室内。
可选择地，在开心手术期间，假体100可以经过在心脏125的心房壁内的开口插入到左心房126内。虽然在开心过程期间假体100可以更容易地看到和定位，但经皮递送具有很小的侵入性，因此包括大致更低的并发症的风险。
图5A-8B
在图5A-7B中，可以看到根据本发明的假体200的另一个优选实施例。尽管大体上类似于假体100，但假体200还包括四个扩张成将假体200锚定在左心房126内并且沿着二尖瓣连合处的长度将袋206定位在二尖瓣小叶122之间的锚定环202。就此而言，锚定环202可以更一般地描述为锚定框架或锚定结构。
袋206由为袋206提供了支撑框架的支撑臂204和底部支撑件208支撑。优选地，侧臂204和底部支撑件208是连接到锚定环202的单根的一体的丝，然而，例如通过焊接或锡焊等，多段的丝可以连接在一起。如先前所描述的假体100的实施例那样，支撑臂204和底部支撑件208优选地包括弹性的形状记忆材料，例如镍钛诺，其允许假体200如在图7A和7B中所看到的那样压缩并且加载到导管110内，然后如在图5A-6中所看到的那样展开到预定形状。优选地，用于支撑臂204和底部支撑件208的丝确定尺寸和形状为使小叶122的自由边缘变形最小，因此使二尖瓣几何形状扭曲最小。就此而言，袋支撑臂204可以可选择地描述为框架、支撑结构或定位架。
袋206类似于先前实施例的袋106，优选地包括柔性的生物或人造材料，其确定尺寸和形状为形成带有反向于锚定环202的开口的袋形状。袋206可以直接缝纫、粘合或附着到用于支撑的外部支撑臂204。可选择地，袋206的柔性织物可以缝纫为形成用于在袋206的外部表面上的支撑臂204的延长的通道。
如在图6中所最佳看到的那样，袋206至少部分地定位在二尖瓣120内，从而使袋206的开放端面向左心室128。在这种构型内，袋206在心脏舒张期间缩小，使血流在二尖瓣120内阻塞最小，而在心脏收缩期间扩张，至少部分地填充在二尖瓣小叶122之间的任何开口，由此使血流反流到左心房126内最小。
如就假体100所描述的那样，假体200优选地通过经皮递送导管110递送到左心房126，但也可以在开心手术期间植入。由于袋206具有在二尖瓣120内需要特殊取向的水平延长的形状，所以与在开心手术期间进行递送相比，经皮将假体200递送到适当的位置可能是较困难的。因此，如在图8A和8b中所看到的那样，递送导管110可以包括收回线210和推杆212，以将假体200收回到导管110内，而在左心房126内新的位置将假体200重新展开。
优选地，收回线210包括细但强的材料，例如金属、丝或聚丙烯，并且是单段的。收回线210的两个自由端都定位在递送导管110的近端，同时线210的主体延伸经过递送导管110、经过每个锚定环202而往回经过导管110。
基于在扩张状态下的假体200的构型，收回线210单独可能提供不了完全将假体200重新压缩并且重新捕获所需要的力。在这样的情况下，推动件杆212可以与收回线210一起使用，以操纵假体200形成适合于重新捕获在递送导管110内的形状。例如，递送导管110的操作者可以拉动收回线210，同时用推动件杆212推动锚定环202。同时进行推动和拉动使锚定环202变形成可以较容易地被递送导管110重新捕获的延长的形状，允许使用者重新定位递送导管110的远端，并且将假体200重新展开。
图9A-9E
图9A-9E图示了假体250的另一个优选实施例，其大部分类似于先前在图5A-8B中所显示的假体200，具有固定到支撑臂258的锚定环252和布置在支撑臂256之间的袋254。然而，如在图9E中所最佳看到的那样，本假体250的支撑臂258定位并且接附在袋254内而不是在袋254的外部表面上，与假体200比较，形成了更均匀的外部表面形状。额外地，底部支撑件256包括构造为将力施加靠在支撑臂258上以使袋254维持完全扩张的位置的环256A。
图10A-11
图10A-11图示了根据本发明的假体300的又一个实施例，其大体上类似于本说明书的先前所描述的实施例，具有支撑由柔性材料制造的袋306的支撑臂304。
不同于在本说明书中先前所描述的实施例，假体300包括与支撑臂304一体的锚定笼302。优选地，例如通过用激光将管切制成想要的样式，或通过用于制造支架的其它技术，锚定笼302和支撑臂304由单根的金属管切制。组成管的金属优选地包括形状记忆材料，例如通常用于支架的那些材料，例如镍钛诺。就此而言，锚定笼302可以更一般地描述为锚定框架或锚定结构。
与在本说明书中先前描述的实施例相比，一旦在左心房126内扩张，锚定笼302就在更多的位置内接触左心房126的组织，因此更均匀地将锚定力分配在左心房126内。额外地，锚定笼302的扩张形状可以确定形状为更好地符合于左心房126的几何形状，因此更准确地将袋306定位在想要的部位。
如本说明书的先前所描述的实施例那样，如在图11中所看到的那样，假体300优选地用递送导管110经皮递送，但可以可选择地在开心手术期间展开。如在图11中所看到的那样，在经皮展开的情况下，假体300压缩到相对小的展开前状态。
图12A-13
图12A-13图示了根据本发明的假体400的另一个优选实施例，其大体上类似于先前所描述的实施例，例如在图5A-8B中所显示的假体200。更特殊地，假体400类似性包括经由支撑臂404锚定并且定位袋406的锚定环402。袋406类似地定位在二尖瓣120内，从而当二尖瓣120闭合的时候，扩张到在二尖瓣小叶122之间的任何开口内。
与先前所描述的实施例对比，假体400包括多个锚定环402，这些锚定环402形成具有终止区域408的球形的柠檬形状。锚定环402的整体形状扩张成以不同的角度将压力施加靠在左心房126上，这更好地维持了假体400的位置。额外地，终止区域408可以压靠在左心房126的组织上，或可以可选择地定位在位于左心房126的壁内的切口(例如在心房隔膜内的经皮进入切口)内，以进一步提供锚定支撑。
假体400的主体包括确定形状为形成锚定环402的丝402A-402E及两个袋支撑件404。丝402B、402C和402D确定形状为具有大体上为圆形的形状，而自由端中的每个都被终止区域408捕获。就此而言，每根丝402B、402C和402D都形成假体400的单个的环。
丝402A的一端固定在终止区域408内，而另一端向下延伸为形成袋支撑件404，在两端之间包括弯弓形状，形状类似于丝402B、402C和402D所形成的形状。第二个袋支撑件404由类似地固定在终止区域408内的丝404E形成。如在本说明书中先前所描述的实施例那样，如在图13中所最佳看到的那样，袋406固定到袋支撑件404，由此在二尖瓣120内将袋406维持在想要的部位。就此而言，锚定环402可以更一般地描述为锚定框架或锚定结构。
图14A-16B
在于图14A-16B中所图示的另一个优选实施例中，显示了根据本发明的假体500。类似于在本说明书中所讨论的先前实施例，假体500包括由锚定丝502支撑和定位的袋506。尽管本假体500包括弯曲的锚定区域502A，类似于先前所讨论的实施例的弯曲的锚定丝，但这些锚定区域502A包括单根的锚定丝502。通过使用单根的锚定丝502，假体500使可能另外存在的尖锐的端部或边缘最少化。就此而言，锚定丝502可以更一般地描述为锚定框架或锚定结构。
如在图16A和16B中所看到的那样，一种递送假体500的可能的方法包括将假体500压缩或加载在经皮递送导管110内，并且将假体500递送到左心房126。一旦在左心房126内，假体500就扩张到在图15中所看到的预定形状。因而，类似于先前所讨论的实施例，假体500维持了袋506在二尖瓣120内的位置，减小了反流。
图17A-17D
图17A-17D图示了根据本发明的假体600的又一个优选实施例，类似于在本说明书中先前所描述的实施例，通过将袋606锚定在二尖瓣120内，其减小了二尖瓣反流。
相反地，本假体600包括确定形状为具有更紧密地相似于左心房126的不对称内部的不对称蛋结构的锚定丝602。由于锚定丝602的不对称性匹配于左心房126的自然不对称性，所以假体600自身在预定位置内扩张和取向，提供袋606与二尖瓣120稳定锚定和一致对准。此外，这种不对称的设计有助于从经过心房隔膜的切口的位置进行递送和展开，因为假体600扩张成牢固地接合左心房126的几何形状。就此而言，锚定丝602可以更一般地描述为锚定框架或锚定结构。
当完全扩张的时候，袋606也包括放射状或圆筒形的形状，并且可以更一般地描述为可扩张的闭塞部件或接合部件。无论袋606相对于二尖瓣小叶122(即二尖瓣120的连合处)如何进行转动取向，放射状的形状都施加类似的均匀液压功能。就此而言，在对减小反流没有不利影响的情况下，假体600可以展开为更多的取向。
图18A-18D
图18A-18D显示了根据本发明的假体700的另一个优选实施例，其很像先前所描述的假体600，具有形成类似于左心房126的几何形状的不对称形状的锚定丝702。然而，本假体700包括带有延长的非放射状形状的袋706，其通过转动旋转件710连结到锚定丝702。旋转件710允许在袋706和锚定丝702之间进行转动，无论锚定丝702如何取向，都允许袋706在二尖瓣120内达到想要的转动取向。就此而言，锚定丝702可以更一般地描述为锚定框架或锚定结构。
如在图18D中所最佳看到的那样，旋转件710包括从袋706的看不到的丝支撑件延伸的丝环708。锚定丝702包括盘绕且由此接合丝环708的丝卷704，允许锚定丝702相对于袋706进行转动。就此而言，通过首先在二尖瓣120内将袋706定位在想要的位置，然后在不需要对假体700的整体转动取向进行调整的情况下，将锚定丝702展开，外科医生可以更容易地经皮将假体700展开。额外地，假体700转动的能力允许袋706自身对准，从而使每个二尖瓣小叶122接触靠在袋706的延长侧上。
图19A-19D
图19A-19D图示了假体800的优选实施例，其类似于在本说明书中先前所描述的实施例，尤其是在图18A-18D中所显示的假体700。更特殊地，假体800包括扩张成类似于左心房126的几何形状的不对称形状的锚定丝802。额外地，假体800包括通过转动连合件810连结到锚定丝802的延长的袋806。就此而言，锚定丝802可以更一般地描述为锚定框架或锚定结构。
与先前所描述的假体700对比，假体800包括袋支撑丝804，其不但如在本说明书中在其它实施例中所描述的那样支撑袋806的结构，而且如在图19D中所最佳看到的那样围绕圆柱件808缠绕，然后径向向外分支成环形状804A。锚定丝802的端部连结在圆柱件808内，从而允许锚定丝806相对于袋806进行自由的转动。
袋支撑丝804的成环区域804A有助于自由转动的袋806在二尖瓣120内自身取向成想要的位置。额外地，这些外部成环区域804A可以确定尺寸和形状为通过位于二尖瓣120的环上而支撑袋806。
可选择地，袋支撑丝804的成环区域可以确定形状为至少部分地与锚定丝802的部分相互锁定，以允许锚定丝802在袋支撑丝804的环的长度所确定且因此约束的范围内进行自由的转动。通过允许至少在一定程度上对在展开构型内的袋806进行转动控制，这样的转动约束可以更好地有助于外科医生进行递送和展开。
图20A-21B
图20A-21B图示了根据本发明的假体900的又一个优选实施例，其大体上类似于本说明书的先前所讨论的实施例，例如图17A-17D的假体600。例如，假体900包括具有放射状形状的袋906和袋支撑丝908及固定到袋906并且具有大体上匹配于左心房126的内部几何形状的不对称形状的锚定丝902。
然而，假体900包括两个可分别展开的支撑结构：先前所提及的锚定丝902和内部支撑丝904。内部支撑丝904包括延长区域904A和锚定区域904B，锚定区域904B作为支撑丝908而在袋906内延续。锚定丝902和内部支撑丝904可以更一般地描述为锚定框架或锚定结构。
如在图21A和21B中所最佳看到的那样，在用递送导管110进行经皮递送期间，支撑结构902和904可以分别展开。当假体900被推出递送导管110的时候，包括延长区域904A和锚定区域904B的内部支撑丝904首先扩张，同时锚定丝902保持相对压缩。
锚定区域904B的扩张形状优选地确定尺寸和形状为接合二尖瓣120的环的至少部分。就此而言，使用者可以将袋906引导到在二尖瓣120内的想要的位置，同时锚定区域904B扩张成至少部分地将袋906锚定在适当的位置。一旦使用者达到用于袋906的想要的位置，剩余的锚定丝902就可以从递送导管110展开，允许其扩张成压靠在左心室126上，由此进一步将假体900锚定在适当的位置。
图22A-22C
图22A-22C图示了根据本发明的假体1000的又一个优选实施例。大体上，这个假体1000类似于在本说明书中先前所描述的实施例，例如图17A-17D的假体600，包括锚定丝1002、袋支撑丝1004和具有放射状形状的袋1006。
除了这些类似性之外，假体1000包括朝向袋1006的开放端弯曲的锚定丝1002的区域1002A。当在左心房126内扩张的时候，本发明的区域1002A至少部分地接触二尖瓣120的环。这个环支撑件防止袋1006被推动成经过二尖瓣120而进到左心室128内，在左心房120内维持了假体的整体垂直位置。就此而言，锚定丝1002可以更一般地描述为锚定框架或锚定结构。
图23A-23D
现在翻到图23A-23D，显示了根据本发明的假体1100的又一个优选实施例。再次地，这个假体大体上类似于在本说明书中所描述的先前实施例，包括具有延长的形状的袋1106、锚定丝1102和部分地支撑袋1106并且从袋1106的顶部部分延伸出来的下部环1104。
然而，锚定丝1102的自由端围绕下部环1104卷绕，允许锚定丝1102的环在下部环1104上枢转，以达到更复杂的锚定构型。通过达到更复杂的锚定构型，假体1100可以更好地支撑，因此随着时间过去更恒定地定位袋1106。就此而言，锚定丝1102可以更一般地描述为锚定框架或锚定结构。
图24A-24E
图24A-24E图示了根据本发明的假体1200的另一个优选实施例，具有带有延长的形状的袋1206、作为在袋1206内的看不到的袋支撑丝的部分的枢转环1204和具有围绕枢转环1204卷绕的区域1210以形成自由转动枢转件1212的锚定丝1202。
如在图24E中所最佳看到的那样，为了使锚定丝1202的设计额外地复杂，锚定丝的部分用针织件1208彼此固定。通过达到额外的复杂性并且使结构成环，假体1200能够更好地锚定在左心房126内，因此将自身固定在左心房126内。此外，针织件1208允许锚定丝1202的结合区域相对于彼此进行铰接，这可以允许在递送导管110内的装填更有效，或使在左心房126内的展开手段更复杂。就此而言，锚定丝1202可以更一般地描述为锚定框架或锚定结构。
图25
翻到图25，图示了根据本发明的假体1300的又一个优选实施例。特殊地，假体1300展示了袋1306，袋1306具有大体上类似于在本说明书中先前所描述的实施例的袋支撑件1304，并且还包括连结到袋支撑件1304的支架锚定件1302。就此而言，支架锚定件1302可以更一般地描述为锚定框架或锚定结构。
如在本领域中所知道的那样，支架锚定件1302可以包括多种不同的材料和结构。例如，在编号为6,936,067、6,929,658、6,926,743、6,923,828和6,902,575的美国专利中，可以看到一些支架技术；在这里，每项专利的内容都通过参考予以合并。
图26A-26B
翻到图26A和26B，图示了根据本发明的假体1400的又一个优选实施例，其包括用于袋1406的可选择的锚定和定位系统。特殊地，具有多个隔膜接附臂1402的定位臂1402锚定在心房隔膜125内，隔膜接附臂从定位臂1402的基部延伸，并且压靠在心房隔膜125的右侧和左侧上。优选地，隔膜接附臂1402的尺寸和形状类似于在本领域中所知道的心房隔膜闭合装置的尺寸和形状。就此而言，定位臂1402可以更一般地描述为锚定框架或锚定结构。
就此而言，假体1400可以经由在心房隔膜125内的切口进行递送，首先将袋1406定位在二尖瓣120内，然后为了进行锚定支撑而将隔膜接附臂1404延伸成靠在心房隔膜125的右侧和左侧上。定位臂1402大致上使在心房隔膜125内的切口闭塞，同时隔膜接附臂1402保持围绕定位臂1402的隔膜组织，防止血液经过隔膜125之间。
尽管在本说明书中所披露的优选实施例包括可扩张的袋，但应该理解的是，其它设计可以与本发明所想到的锚定设计一起使用。例如，结实并且优选柔性的片部件可以可选择地使用，其具有类似的形状和尺寸，如就本说明书的实施例的袋所描述的那样。
优选地，结实的部件是相对柔软的，具有允许在一定程度上进行压缩的柔性，尤其是当被二尖瓣小叶接触的时候。更优选地，通过将两片心包组织附着在一起，并且提供支撑部件或丝，类似于就在先前实施例中的袋所描述的，结实的部件可以形成。镍钛诺细线代替支撑部件而可以接附到结实的部件和左心室128，防止结实的部件移动到左心房126内。替代地，结实的部件可以包括弹性的生物相容的聚合物材料，例如聚氨酯。
优选地，本说明书的实施例也可以包括连接锚定环或锚定丝的柔性的聚合物片，例如聚氨酯，锚定环或锚定丝接触左心房126。就此而言，通过更均匀地分配锚定力，柔性的片进一步减小了在左心房壁上的应力。
应该理解的是，本申请的实施例的不同元件可以组合为形成本发明所想到的额外的设计。例如，在图26A和26B中所显示的隔膜锚定假体1400可以与就图20A-20C的假体900所显示的锚定结构相组合。
尽管在本发明中所披露的实施例特殊地描述为用于心脏的二尖瓣，但应该想到的是，这些实施例可以适合于用于其它心脏瓣膜。例如，锚定结构可以修改为在心脏内压靠在不同的几何形状上，而袋可以适合于不同形状的瓣膜，例如三尖瓣。
虽然就特别的实施例和应用描述了本发明，但基于本教示，在本领域中的普通技术人员可以在不偏离本发明的主旨或不超越本发明的范围的情况下，实施额外的实施例，并且进行额外的修改。因此，应该理解的是，附图和描述在这里作为例子提供以有助于理解本发明，而不应该用来限制其范围。

Claims (14)

1.一种用于治疗瓣膜反流的装置，其包括：
确定尺寸为至少部分地放置在瓣膜的小叶之间的接合部件，所述的接合部件具有扩张状态和缩小状态，并且具有大致上等于所述的小叶的连合处的长度；和
连接到所述的接合部件的锚定结构，所述的锚定结构具有确定尺寸为配合在递送导管内的压缩状态和确定尺寸为固定在邻近所述的瓣膜的腔的壁的至少部分上的扩张状态，
所述的接合部件包括柔性袋，所述的柔性袋包括布置在支撑结构上的柔性材料，所述的支撑结构确定尺寸为使得所述的柔性袋沿所述的连合处的长度延伸。
2.根据权利要求1所述的装置，其特征在于，所述的柔性材料是心包组织。
3.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括锚定丝。
4.根据权利要求3所述的装置，其特征在于，所述的锚定丝确定形状为固定成靠在左心房的壁上。
5.根据权利要求3所述的装置，其特征在于，所述的锚定丝确定形状为接触二尖瓣环。
6.根据权利要求1所述的装置，其特征在于，所述的锚定结构确定尺寸为大致上符合于左心房的一部分。
7.根据权利要求1所述的装置，其特征在于，所述的锚定结构可转动地连接到所述的接合部件。
8.根据权利要求1所述的装置，其特征在于，所述的锚定结构确定尺寸为固定在心房隔膜上。
9.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括支架部分。
10.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括圈。
11.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括多个环。
12.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括具有多个弯曲部分的丝。
13.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括锚定笼。
14.根据权利要求1所述的装置，其特征在于，所述的锚定结构包括具有确定尺寸为固定成靠在邻近所述的瓣膜的腔的壁的所述的部分上的扩张形状的第一锚定部件和具有确定尺寸为固定成靠在瓣膜环上的扩张形状的第二锚定部件。
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