CN1984621A - 瓣膜周围渗漏的检测、密封、及预防 - Google Patents

瓣膜周围渗漏的检测、密封、及预防 Download PDF

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CN1984621A
CN1984621A CNA2005800222665A CN200580022266A CN1984621A CN 1984621 A CN1984621 A CN 1984621A CN A2005800222665 A CNA2005800222665 A CN A2005800222665A CN 200580022266 A CN200580022266 A CN 200580022266A CN 1984621 A CN1984621 A CN 1984621A
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valve
cavity
conduit
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B·斯潘塞
N·贝尼霍
A·巴什
M·德达什蒂安
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Edwards Lifesciences PVT 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
    • A61F2/2412—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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • 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
    • A61F2/2472—Devices for testing
    • 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

本发明提供了一系列新的用于瓣膜周围修复的经皮治疗概念，包括确定渗漏位置，一些修复技术，及设置在经皮瓣膜上用于防止渗漏的内置装置。导管输送装置定位假体瓣膜与体管壁(瓣膜植入于此)之间产生的空腔，该空腔在心舒张期间产生瓣膜周围渗漏，该装置包括多个柔性线中至少一者，该线附装有气球，其中该气球由渗漏拉动通过空腔，且其中所述线于是用于标记空腔位置。

Description

瓣膜周围渗漏的检测、密封、及预防
技术领域
本发明涉及可植入装置。具体而言，涉及对围绕心脏瓣膜假体的瓣膜周围渗漏(paravalvular leaks)的预防、检测、及修复。
背景技术
心脏瓣膜植入技术已被业界所公知。所欠缺的是如何检测瓣膜与周围血管之间的潜在渗漏、如何密封这种渗漏、或如何设计一种瓣膜使得其可自动地密封渗漏。
Machiraju在发明名称为“HEART VALVE”的美国专利号5,554,184中描述了心脏瓣膜以及用于进行瓣膜置换或修复的技术，该技术以从心包膜、阔筋膜或甚至硬膜的自体移植，或以牛的或猪的心包膜或其他与其类似的人工合成片材(其优选地具有基本上复原包括附在心脏的相邻的乳头肌上的腱索的心脏原始解剖学组织结构的构造)，来部分或完全地置换二尖(或三尖)瓣膜。最优选的是，将患者的心包膜的一部分切割为具有两个小叶的形状，其中每个小叶都具有以矛状突起终结的腱索的有小梁层(trabeculated tier)。将两个小叶作为单一单元切割而成，而将两个末端缝合在一起以生成附有腱索及突起的双小叶瓣膜。
Machiraju并未解决可能会在植入的瓣膜周围发生的渗漏。
Schreck在发明名称为“MINIMALLY-INVASIVE HEART VALVES ANDMETHODS OF USE”的美国专利号6,454,799中描述了用于最低程度侵入式瓣膜置换外科手术的可伸展心脏瓣膜。在第一实施例中，可伸展预装心脏瓣膜包括具有多个直立接合柱的塑性可伸展环状基体。设置有包括修复部分及纤维部分的管状柔性构件，其中该修复部分连接至接合柱并在其间界定有小叶，而纤维部分附装至环状基体。在第二实施例中，可伸展心脏瓣膜包括环状组织配合基体及具有弹性线构型(wireform)及多个连接至其的小叶的子组件。环状基体及子组件独立存储而在将要移植至宿主环面之前连接。优选的，小叶子组件以其松弛的结构存储以避免小叶的形变。可伸展心脏瓣膜可利用气囊导管植入。优选的，心脏瓣膜的小叶利用钳拉配置固定至可伸展支架(stent)的连合区域以降低应力。
Schreck也未解决可能会在植入的瓣膜周围发生的渗漏。
Amplatz在发明名称为“INTRAVASCULAR FLOW RESTRICTOR”的美国专利号6,638,257中描述了一种血管内限流器，其包括被设计以布置在肺主动脉内用于限制肺脏内血液压力的编织管状结构。此编织结构设计为收缩以放置在输送导管内，但当其从输送导管被弹出时，其呈现为具有一个或更多纵向槽或通路在其中通过的足够大直径的盘状装置。
Amplatz也未解决可能会在植入的瓣膜周围发生的渗漏。此外，Amplatz的编织结构的形状及尺寸并不适合瓣膜周围渗漏的检测及密封。其结构是设计用于管(transceptal)孔情形而不适用于瓣膜周围渗漏。
Spenser等人在发明名称为“IMPLANTABLE PROSTHETIC VALVE”的美国专利申请号20030153974中描述了一种适于植入体管内的修复装置。该装置包括(1)由可展开结构构成的支撑支架(support stentbring)，该可展开结构适于在最初卷曲为较窄的结构以适于导管插入通过体管到达目标位置，并适于通过展开装置从内部施加大体径向的力而在目标位置展开为展开状态，支撑支架设置有多个固定长度的纵向刚性支撑梁，以及(2)瓣膜组件，其包括具有入口端及出口的柔性导管，该柔性导管由附装至支撑梁的柔顺材料制成，以在出口处提供了导管的可收缩式松弛部。当允许液流从入口通过瓣膜修复装置到达出口时，保持瓣膜组件处于打开位置，但因瓣膜组件可收缩式松弛部向内收缩以提供对反向液流的阻塞，故可防止反向液流。
Spenser等人也未解决可能会在植入的瓣膜周围发生的渗漏。
就假体瓣膜这个总的概念而言，当今或通过直视心外科手术，或通过使用新近的经皮方法来进行植入，其中的一些在上述专利中有所描述。对于两种方法而言，瓣膜周围渗漏均是公知的副作用。解决渗漏问题的一种方法是确定渗漏位置并将其修复。另一种方法是为假体设置装置以防止渗漏(“自密封”假体)。本发明包括这两种方法。
经皮引入医用装置是优选的外科操作，因为其仅在局部麻醉的情况下在患者的皮肤上(通常在腹股沟或腋窝区域)产生极小的穿孔。相较而言，通过外科手术设置会涉及大的开胸外科手术，并需要全身麻醉，以使患者的胸部的大部分暴露。因此，经皮引入被认为更为安全且侵入较小。
经皮引入渗漏检测及修复装置或引入自密封瓣膜类似于其他公知的介入性心脏手术。经皮展开处理及装置对产品设计的某些参数有影响，其中的一些将在以下描述。
总而言之，本发明提出了经皮瓣膜周围修复的新概念，包括用于确定渗漏位置的装置、修复技术以及可被设置在假体瓣膜自身内用于防止渗漏的装置。
发明内容
根据本发明的优选实施例，提供了一种用于定位在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送装置，所述空腔在心舒张期间产生瓣膜周围渗漏。所述装置包括多个柔性线中的至少一者，所述线附装有气球，其中所述气球由所述渗漏拉动通过所述空腔，且其中所述线于是用于标记所述空腔位置。
此外，根据本发明的另一优选实施例，设置有分隔元件以维持邻近所述体管的所述壁的所述线。
此外，根据本发明的另一优选实施例，还提供了一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送支架，所述空腔在心舒张期间产生瓣膜周围渗漏。所述支架通过导引线输送至所述空腔，通过摩擦在所述空腔中保持在位，并包括支撑结构及不渗透薄膜，所述薄膜防止流体通过所述支架，由此密封所述空腔。
此外，根据本发明的另一优选实施例，所述密封支架为可气球充气型，且所述薄膜包括弹性铰接至所述支架管腔的内部并确定尺寸以在关闭时阻塞所述管腔的突片，所述突片在插入期间通过所述支架气球保持打开，并在所述支架扩展后当所述气球移除时回弹关闭。
此外，根据本发明的另一优选实施例，所述密封支架可自扩展，其中所述薄膜是覆盖所述支架的至少一端的材料。
此外，根据本发明的另一优选实施例，所述支架由形状记忆材料制成。
此外，根据本发明的另一优选实施例，所述材料是镍钛诺。
此外，根据本发明的另一优选实施例，在所述支架的外壁上覆盖有由形状记忆材料制成的钩，所述钩在所述支架插入时延伸进入邻近的体管壁。
此外，根据本发明的另一优选实施例，所述支架输送导管的末端在所述空腔内部一点处大体垂直于所述管壁，且所述支架导引线以锚定机构终止，该锚定机构插入通过所述导管并进入所述管壁，由此将自身锚定在所述管壁中并为所述支架提供更大的锚定力。
此外，根据本发明的另一优选实施例，所述锚定机构是由形状记忆材料制成的钩，所述钩收缩用于导管输送进入所述管壁，在该位置所述钩伸出，由此将所述导引线锚定进入所述管壁。
此外，根据本发明的另一优选实施例，所述锚定机构是拧入所述管壁由此将所述导引线锚定进入所述管壁的螺纹部。
根据本发明的优选实施例，还提供了一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的装置，所述空腔在心舒张期间产生瓣膜周围渗漏。所述装置包括穿线通过所述空腔的第一导引线、滑动地耦合至第一线并被插入使得所述可滑动耦合移动至所述空腔内的位置的第二导引线、在所述第一导引线上插入到达所述空腔内的位置的第一导管、在所述第二导引线上插入到达所述空腔内的位置的第二导管、通过所述第一导管插入到达期望位置的双组分生物粘合剂的第一组分、通过所述第二导管插入到达期望位置的双组分生物粘合剂的第二组分，且所述两种组分由此混合以形成密封所述空腔的栓。
此外，根据本发明的另一优选实施例，所述装置适于施加具有多于两种组分的粘合剂。
此外，根据本发明的另一优选实施例，使用单个导管及导引线替代两个导引线及两个导管用于输送，其中所述导管具有两个管腔，每个管腔都提供用于所述双组分粘合剂组分其中一者的输送，所述导管终止在混合器中，当离开所述导管进入所述空腔时，所述混合器迫使所述组分混合，由此产生密封所述空腔的栓。
此外，根据本发明的另一优选实施例，通过所述导管中的一者输送射线固化粘合剂并通过另一导管输送射线源，来替代通过所述导管输送双组分粘合剂组分，其中所述射线源被施加至所述粘合剂以在所述空腔内产生所述栓。
根据本发明的优选实施例，还提供了一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送装置，所述空腔在心舒张期间产生瓣膜周围渗漏。所述组件通过导引线输送至所述空腔，并包括通过缝线连接的两个密封支架，所述缝线向上返回所述导管，所述密封支架包括支架结构及密封薄膜。所述组件的一个支架插入到所述空腔之下而另一支架插入所述空腔内部，所述薄膜防止流体通过所述支架，由此密封所述空腔且每个支架均有助于将另一支架锚定到位。
根据本发明的优选实施例，还提供了一种假体瓣膜，具有附装至外壁的集成密封环，所述环具有大于所述瓣膜的外周，并弹性地适形以密封所述瓣膜与所述瓣膜植入处的体管的壁之间的空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
此外，根据本发明的另一优选实施例，所述环包括气球。
此外，根据本发明的另一优选实施例，所述环包括多个弹性线突片，所述突片围绕所述瓣膜的外周彼此邻近安装，并由不渗透薄膜覆盖。在导管输送期间所述突片抵靠所述瓣膜的主体折叠，且当离开所述导管时，所述突片回弹以形成所述密封环。
此外，根据本发明的另一优选实施例，所述环包括多个围绕所述瓣膜的外周彼此邻近安装的不渗透突片，并还包括所述突片下方的气球。所述突片在导管输送期间向下折叠在放气气球上，且其中当离开所述导管时，所述气球充气，由此打开所述突片以形成所述密封环。
此外，根据本发明的另一优选实施例，所述环包括多个围绕所述瓣膜的外周彼此邻近安装的不渗透突片，每个突片都弹性铰接至所述瓣膜。在导管输送期间所述突片抵靠所述瓣膜的主体折叠，且当离开所述导管时，所述突片回弹出去以形成所述密封环。
此外，根据本发明的另一优选实施例，所述环包括多个柔性自扩展密封元件中的至少一者，所述密封元件由被不渗透薄膜覆盖的自扩展栅网构成。
此外，根据本发明的另一优选实施例，所述环包括多个柔性自扩展密封元件中的至少一者，所述密封元件由被不渗透薄膜覆盖的自扩展栅网构成。
此外，根据本发明的另一优选实施例，所述密封环包括所述支架的改变支柱，改变包括几何结构约束，当所述支架扩展时，该几何结构约束使得所述支柱折弯离开所述支架主体，由此产生所述密封环。
根据本发明的优选实施例，还提供了一种具有集成的密封装置的假体瓣膜，所述密封装置包括围绕所述瓣膜的外周附装并向后延伸离开身体的缝线。修复片可被推至所述缝线之下，并被附装至缝线附装至所述瓣膜的位置，由此密封在所述瓣膜与瓣膜植入处的体管的壁之间存在的任何空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
根据本发明的优选实施例，还提供了一种具有集成的密封装置的导管输送假体瓣膜，所述密封装置包括首先被展开且瓣膜在其中展开的弹性支架。所述弹性支架密封在所述瓣膜与瓣膜植入处的体管的壁之间存在的任何空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
根据本发明的优选实施例，还提供了一种用于密封在植入假体瓣膜与体管的壁之间产生的空腔的方法，所述瓣膜植入在所述壁中，所述空腔在舒张期间产生瓣膜周围渗漏。所述方法包括：将不渗透支架插入空腔，由此使支架密封空腔。
根据本发明的优选实施例，还提供了一种用于密封在植入假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的方法，所述空腔在心舒张期间产生瓣膜周围渗漏。所述方法包括：
将第一导引线插入空腔；
在第一导引线上将附装至第二导引线的环移动至空腔内的位置；
将双组分粘合剂的一种组分通过第一导引线上的导管注入到达空腔；并
将双组分粘合剂的第二种组分通过第二导引线上的导管注入到达空腔，
其中两种组分结合以产生密封空腔的粘合栓。
此外，根据本发明的另一优选实施例，注入射线固化粘合剂来取代第一粘合组分，并施加射线源来取代第二粘合组分，由此产生粘合剂栓。
此外，根据本发明的另一优选实施例，仅使用一个导引线，且两种组分通过在导引线上的单个导管内的不同管腔被插入。
根据本发明的优选实施例，还提供了一种带支架瓣膜，其中诸如布料或织物的可压缩材料围绕支架的外部延伸。可压缩材料可由聚对苯二甲酸乙二醇酯形成且被构造以延伸进入缝隙。此外，材料上的纤维可被构造为促进血液凝结以进一步填充缝隙并防止渗漏。在一种改变示例中，可以在材料上施加组织生长因子以促进材料与周围组织之间的组织生长。
根据本发明的优选实施例，还提供了一种用于在植入假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔中提供集成密封能力的方法，所述空腔在心舒张期间产生瓣膜周围渗漏。所述方法包括：
围绕瓣膜的外部设置可扩展弹性环；和
扩展环，
其中所述环密封任何空腔。
根据本发明的优选实施例，还提供了一种用于密封在植入假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的方法，所述空腔在心舒张期间产生瓣膜周围渗漏。所述方法包括：
在空腔的远端插入密封支架；并
将附装至第一支架的第二密封支架插入空腔。
附图说明
为了更好的理解本发明本领会其实际应用，提供了附图并在以下进行参考。注意，附图仅为示例性而绝不应限制界定在所附权利要求中的本发明的范围。类似的组件由类似的参考标号示出。
图1示出了具有产生瓣膜周围渗漏的空腔的植入瓣膜，以及根据本发明的实施例的装置，其包括具有充气气球的并设计用于确定瓣膜周围渗漏的准确位置的软导引线。
图2a及图2b示出了根据本发明的另一优选实施例的在软导引线上、设计用于确定围绕植入瓣膜的瓣膜周围渗漏的多个气球。
图3示出了根据本发明的另一优选实施例的在软导引线上并通过环沿血管的周边保持的、设计用于确定围绕植入瓣膜的瓣膜周围渗漏的多个气球。
图4a至图4c示出了根据本发明的另一优选实施例的在导引线上将密封支架插入以封闭瓣膜周围渗漏的处理。
图5a至图5d示出了根据本发明的另一优选实施例的数种密封支架。
图6a至图6d示出了根据本发明的另一优选实施例的通过由将装置附装至主动脉壁(或环面)的锚来辅助密封装置以阻塞瓣膜周围渗漏。
图7示出了根据本发明的另一优选实施例的用于实现图6所示的密封的锚定设备，在此情况下是通过利用嵌入主动脉壁(或环面)的螺纹部。
图8a和图8b示出了根据本发明的另一优选实施例利用双组分生物胶完成渗漏修复。
图9a至图9c示出了根据本发明的另一优选实施例利用紫外线固化生物胶完成渗漏修复。
图10示出了根据本发明的另一优选实施例的将双组分生物胶插入气球以阻塞瓣膜周围渗漏的导管。
图11a至图11f示出了根据本发明的另一优选实施例的用于使用两个连接的密封支架来阻塞瓣膜周围渗漏的装置及处理。
图12示出了根据本发明的另一优选实施例的瓣膜，其具有允许填充瓣膜支架与主动脉壁之间的缝隙以防止瓣膜周围渗漏的内置充气部。
图13a至图13d示出了根据本发明的另一优选实施例的瓣膜，其具有用于阻塞围绕支架的可能渗漏的柔性及自膨胀部。
图14a至图14c示出了根据本发明的另一优选实施例的瓣膜，其具有用于阻塞围绕支架的可能渗漏的柔性及自膨胀部。
图15a至图15c示出了根据本发明的另一优选实施例的瓣膜，其在其近端具有用于阻塞围绕支架的可能渗漏的多个柔性及膨胀段。
图16a至图16b示出了根据本发明的另一优选实施例的瓣膜装置，其包括用于阻塞围绕支架的可能渗漏的附加部分。
图17a至图17e示出了根据本发明的另一优选实施例的瓣膜装置，其中支架适于在伸展时使支架的一部分被迫径向突出，由此阻塞可能的渗漏。
图18a至图18e示出了根据本发明的另一优选实施例的瓣膜，其被构造具有附装至近侧的附加结构，由此允许附装由心包膜或人造纤维制成的额外零件用于阻塞瓣膜周围渗漏。
图19a至图19d示出了根据本发明的另一优选实施例的处理，该处理包括两个步骤：首先，插入具有外密封层的支架，其次，通过该支架插入假体瓣膜。
图20a至图20g示出了根据本发明的另一优选实施例的瓣膜，其具有由柔性及可膨胀材料制成的用于阻塞围绕支架的渗漏的密封元件。
图21示出了根据本发明的另一优选实施例的瓣膜装置，其中所述密封元件在密封线上附装至瓣膜用于提供改进的卷曲轮廓。
图22示出了根据本发明的另一优选实施例的瓣膜装置，其中沿具有支架的瓣膜的外表面上设置诸如布料的可压缩材料层。
具体实施方式
本发明提供了用于大大减小或有效消除在假体瓣膜中瓣膜周围渗漏造成的不良影响的方法及设备。具体而言，所述方法及设备能够利用专用及集成(与瓣膜)装置来定位、密封并防止瓣膜周围渗漏。
虽然本发明具体适用于假体心脏瓣膜渗漏，诸如假体主动脉瓣膜，但本发明也可适用于诸如血管、隔膜或其他体腔中的其他渗漏问题。类似的，虽然这里描述的假体瓣膜为三尖瓣膜，但其也可以是其他类型的瓣膜。
本发明的主要方面在于提出一些新的用于定位假体瓣膜中的瓣膜周围渗漏的设计及方法。
本发明的另一主要方面在于提出一些新的用于密封在假体瓣膜中发现的瓣膜周围渗漏的设计。
本发明的另一主要方面在于提出一些新的用于修改经皮假体瓣膜以在瓣膜植入时自动密封瓣膜周围渗漏的设计。
本发明的另一主要方面在于提出一种新的在瓣膜植入时自动密封瓣膜周围渗漏而无需对瓣膜修改的设计。
本发明的另一主要方面在于揭示了一些新的用于修改经皮假体瓣膜以能够在瓣膜植入之后密封瓣膜周围渗漏的设计。
为了定位瓣膜周围渗漏，本发明提供了一些设计，其包括安装在柔性导引线上的导管输送气球。将气球输送至瓣膜附近的位置。当在心舒张期间发生血液反流(渗漏)时，气球被引出到在瓣膜与血管壁之间产生的渗漏产生空腔中，由此提供一种手段来输送用于密封渗漏的装置。
为了密封瓣膜周围渗漏，本发明提供了一些设计，包括密封支架、及多组分和射线固化的粘合化合物。
密封支架是卷曲支架，其被输送至渗漏位置、扩展、并锚定到位。设计支架以阻塞液流，由此密封渗漏。对这些处理提出了一些革新。
通过于渗漏位置锚定在血管壁中的导引线来输送密封支架。锚定装置可以是钩，例如由形状记忆合金(例如镍钛合金，也被称为镍钛诺)构成的多头钩，其在低温时卷曲用于输送。由于该装置展开点处的血管壁的较高温度，锚定装置扩展返回至其原始形状，由此将其自身锚定进入血管壁。
另一种锚定手段是使导引线端带螺纹部，螺纹部可被拧入血管壁。
一旦通过导引线输送至渗漏位置，密封的支架就扩展。这可通过其他方式来实现，例如气球、或通过支架自身扩展。在气球充气的情况下，在插入输送导管之前，支架围绕放气的气球卷曲。在输送时气球充气，就扩展支架，然后可以放气并抽出气球。在自身扩展支架的情况下，支架优选地由形状记忆合金制成，例如镍钛合金(也被称为镍钛诺)，其可在较低温度卷曲以输送，因为在展开位置处的较高体温而扩展返回至其原始形状。可替换的是，自身扩展支架可以是金属支架，金属支架由生理可接受金属(例如不锈钢或诸如镍钛诺的合金)构成，其被压紧或缠绕在输送导管或装置上。当从输送导管或装置释放支架时，支架扩展。
密封支架通过摩擦保持在位。通过围绕支架的外周增加诸如由形状记忆合金制成的自扩展钩的钩可获得额外的保持力。
扩展支架包括密封支架的自身管腔的内部元件，从而防止液流通过支架并由此密封导致渗漏的空腔。内部密封元件的示例包括支架管腔内部的基于支架扩展而打开的弹性铰接活叶，在自扩展支架的情况下，内部密封元件的示例包括覆盖支架的一个或两个开口的薄膜。
在一些情况下，使用两个密封支架可能是优选的。在本实施例中，两个支架通过缝线串连在一起。输送导管延伸通过空腔的顶部到达空腔的底部之外以展开其中一个密封支架，然后与支架的导引线一起收回。这样向后拉动展开的支架直至其抓住空腔的底部。导管进一步收回，并将第二支架展开在空腔中。导管进一步收回并将第二支架向后拉动，使其(从底部)抓住空腔的顶部。
密封支架的替换密封元件是生物粘合化合物，其可通过导管插入术输送至空腔。在此情况下，将两个导管布置在渗漏位置。以以下方式中的一种方式来使用导管：输送两种粘合组分(当混合时，其硬化以形成粘合密封栓)，或输送射线固化粘合剂及诸如紫外线源的固化源，以产生粘合密封栓。
在以上两种密封元件设计中，为了正确的混合或固化，均需要使得导管的远端在渗漏位置彼此非常接近。这通过以下来实现：使用第一导管来将上述渗漏检测器导引线插入。第二导引线装配有环，使得环在第一导引线上移动直至其到达渗漏位置。然后各个导管在其导引线上滑动以在渗漏位置相遇，由此提供用于实施双组分粘合剂或射线固化粘合剂的出口。
用于双组分粘合剂的另一输送设计利用了在渗漏检测导引线上移动的单一导管。该导管具有三个管腔：一个用于跟踪导引线，其余用于各个粘合剂组分。在导管的末端处的混合装置将各个组分在渗漏位置混合以形成密封栓。
在本发明的其他实施例中，渗漏密封装置被集成在瓣膜中作用不渗透环，当将瓣膜植入时，其自适应地密封瓣膜与周围管腔之间的任何缝隙。
在这种自密封瓣膜的一个实施例中，将环放气以输送，然后充气以密封。
在另一自密封瓣膜实施例中，环是海绵状材料，其压缩用于输送，然后膨胀用于密封。
在另一自密封瓣膜实施例中，环包括一组活叶，其关闭用于输送，并通过气球充气、通过其至瓣膜的连接的几何结构、或通过弹性作用而打开。
在另一自密封瓣膜实施例中，环包括一组自膨胀管。
在另一自密封瓣膜实施例中，环包括瓣膜的支架的支柱，其被几何地约束以折弯并当从卷曲形状展开时相对于主支架几何结构扩大其最终直径。
在密封装置设置在瓣膜内的另一实施例中，一组丝状体对围绕瓣膜附装并供应返回至输送导管入口。当检测到瓣膜周围渗漏时，诸如心包膜的不渗透材料片被缝合在局部丝状体对上并被向下推至其打结到位的渗漏位置。
在本发明的另一实施例中，首先将密封支架插入管腔，然后将瓣膜插入密封支架内部。
参考附图对上述实施例及其他实施例、制造方法、装置的不同设计及不同类型进行讨论。注意，附图仅用于理解本发明并示出本发明的某些优选实施例。附图不能作为对本发明的范围(由所附权利要求界定)的限制。
图1示出了根据本发明的优选实施例的简单的渗漏检测器27。渗漏检测器27检测普通三尖瓣可植入假体瓣膜20与主动脉环面22之间的渗漏。如将在以下描述的，渗漏检测器27通常将与渗漏密封装置一同使用。
在瓣膜20的外周与主动脉环面22之间存在空腔24。有各种原因会产生空腔24，包括将阻止瓣膜20与环面22之间的正确密封的主动脉环面22的硬化或不规则性。在心脏舒张期间，该空腔会造成血液返流(渗漏)，即以从主动脉进入左心室的血液流25为特征。渗漏检测器27通过导管21输送至瓣膜20上方的位置。渗漏检测器27包括其上安装有可充气气球29的软导引线28，充气气球29在渗漏检测器27已通过导管21之后充气。导引线28足够柔软，使得在舒张期间，充气气球29被引入反流血流并容纳在瓣膜20与环面22之间的空腔24中。
图2a及图2b示出了类似于图1的渗漏检测器27的多个渗漏检测器228，但渗漏检测器228包括多根软导引线31而非检测器27的一根导引线28。在每个导引线31上都安装有气球35。图2b是示出在舒张期间瓣膜20的俯视图。两个空腔24导致血液流动，血流拉动最接近各个空腔24的气球35进入空腔，同时其余气球35保持静止。在该位置，可以确定并标记空腔24的位置并将空腔修复。
图3示出了环形结构渗漏检测器229，其包括改进，该改进可用于强迫渗漏检测器27或多个渗漏检测器228的导引线40保持接近主动脉壁45而防止漂移至主动脉的中心。该改进的优点在于，在检测器27及228的情况下，如果在瓣膜20中存在中心渗漏，主动脉的中心附近的气球可能被引入中心渗漏而非瓣膜周围空腔，由此显示错误的瓣膜周围渗漏。间隔环40是可收缩线环，其在导管21输送之后打开。(多个)导引线42分布开地附装至环40的外边缘，并由此由环保持抵靠主动脉壁45。
图4a至图4c示出了在自然主动脉瓣膜位置处布置、产生在舒张期间导致瓣膜周围血液反流(渗漏)的空腔24的植入瓣膜49。在图4a中，将导引线46(其可以是如图1、图2及图3中的渗漏检测装置)插入通过空腔24。使气球33放气。在图4b中，气球膨胀密封支架(具有不渗透薄膜以防止流体通过支架的支架)在导引线46上通过导管布置。使气球33充气，使得气球膨胀密封支架47展开，由此密封空腔24并阻止瓣膜周围渗漏。图4c示出了类似的渗漏修复，不同之处在于使用了自展开密封支架48，由此不再需要对气球充气。通过密封支架47及48与周围主动脉环面之间的摩擦来锚定这些支架。在以下将描述用于提供对密封支架更强的锚定的装置。
图5a及图5b示出了根据本发明的另一优选实施例的气球膨胀密封支架(例如图4b中所使用的)的实施例。支架的外部51由可通过塑性变形塑形的材料制成。包括不渗透薄膜的密封元件52通过弹性铰链53连接至外部51的内壁。气球膨胀密封支架47卷曲在气球55上。一旦气球55到达空腔24，就将气球充气，由此使密封支架展开(见图5a)。然后将气球33放气，由此(见图5b)通过弹簧53迫使密封元件52关闭并密封支架的管腔。
图5c及图5d示出了根据本发明的另一优选实施例的自扩展密封支架(例如在图4c中使用的)。实现自扩展密封支架的一种方式是利用诸如镍钛诺56的形状记忆材料来制造支架框架56，并使用不渗透材料层58将其覆盖。通过导管将自扩展密封支架输送至空腔，在那里支架打开，其形状调整至空腔的形状且其不渗透覆盖层58密封空腔以防止瓣膜周围血液返流。为了将自扩展密封支架锚定到位，可在框架56上设置钩59。钩59附装至框架56并延伸通过密封材料58进入主动脉环面的壁中。钩可自扩展。实现它们的一种方式是通过诸如镍钛诺的形状记忆材料来制造。
图6a至图6d示出了用于在开放空腔24(其位于主动脉环面63与假体瓣膜20之间，并造成瓣膜周围血液返流)中锚定密封支架66(例如气球膨胀密封支架47或自扩展密封支架48)的技术。在图6a中，通过气球29将导引线61引导通过空腔24(这可通过诸如图1至图3中揭示的装置来实现)。在导引线上供应导引导管603，并将导引线移除。在图6b中，锚定线67(额外的线，终止在锚定设备65中)被插入通过导管63到达空腔24中的锚定位置。锚65是具有一个或更多钩头(其可收缩用于输送并当输送压力去除(即当装置离开输送导管时)时可回弹至其原始位置)的钩。锚65可由柔性材料或形状记忆化合物制成。由于导引导管603的成角度尖端的原因，锚65以接近直角穿透主动脉环面。图6c示出了通过锚定线67插入并扩展以通过图4或图5所示的方法中一者来密封空腔的密封支架66。在图6c所示的情况下，示出了如图4所示的自扩展密封支架。该方法使得相较于单独的摩擦力(其是用于图4及图5所示实施例的唯一锚定方式)改进了锚定力。图6d示出了上述处理的最终步骤，其中线在分离位置68从锚分离。
图7示出了类似于图6中所示出的设备，只是在这里将锚65实现为螺纹部尖端69。锚定通过转动锚定线67来实现，由此将尖端69拧入主动脉环面22。
图8a至图8d示出了根据本发明的另一优选实施例，通过生物双组分粘合材料(例如环氧树脂)来修复瓣膜周围渗漏的设备，该组分为液态，当混合时变为固态。因瓣膜20与环面22之间的开放空腔导致渗漏。使用诸如图1至图3所示的那些渗漏检测器来使得导引线84移动通过空腔24。具有滑动元件85的第二导引线84在第一导引线83上滑动。滑动元件85使得第二导引线84在第一导引线28上滑动，且可以是处于第二导引线84的端部的环。在图8b中，当滑动元件85及第一导引线83到达接近空腔24中途的位置时，使导管86及87分别在导引线28及84上滑动直至导管到达会合位置75。
在图8c中，生物双组分粘合材料的一种组分通过导管86注射，而另一组分通过导管87注射。液体粘合组分在会合位置75处的导管出口会合，混合以产生粘合阻塞元件89，其通过封闭空腔24来修复瓣膜周围渗漏。图8d示出了修复后空腔的最终结果的俯视图，示出了已形成粘合阻塞元件以密封瓣膜20与环面22之间的空腔24。
图9示出了根据本发明的另一优选实施例通过生物粘合剂用于阻塞渗漏的另一设备。两个导引线还是在会合位置75会合，且在该情况下，导管91及93在导引线上供应至会合位置75。但是，在此情况下，阻塞粘合材料包括一种通过使用紫外光存在而固化或其他射线固化的一种液体组分。液体粘合材料通过导管91于导管会合位置75插入空腔24。通过光探针导管93发射的活性波96使材料硬化，从而产生封闭由空腔24导致的渗漏的密封块95。
图10a至图10e示出了根据本发明的另一优选实施例使用双组分粘合材料用于修复瓣膜周围渗漏的另一设备。图10a示出了可在导引线99上滑动至所需位置(位于主动脉82与假体瓣膜81之间的空腔24中)的多管腔导管100。图10b是导管100的多管腔杆的横截面。管腔102及103提供了用于接近粘合剂不同组分的手段。管腔104提供了用于在导引线28上供应导管的手段。图10c示出了双组分粘合剂灌输腔100，其为连接至导管100的端部(接近医疗手术者)的双注射器形式。图10d示出了位于导管100的末端处的混合元件105(其位置见图10a)。混合元件105用于在两种粘合组分被迫离开腔101之后从导管100的末端离开时将两种粘合组分混合，由此确保两种粘合组分在空腔24凝固并固化。图10e示出了在其已通过多管腔导管100及混合元件105由腔101注入空腔24中之后形成栓的粘合组分。固化的粘合剂将空腔添满并阻塞渗漏。在图10e中还示出了可选柔性啮合袋106，其接收并保持粘合剂混合物。该袋防止在插入期间可能产生的粘合材料迁移，并在存在这种瓣膜设计的情况下防止粘合剂穿过支架支柱108。
图11a至图11f示出了根据本发明的另一优选实施例的用于修复瓣膜周围渗漏的设备。两个自扩展密封支架110通过缝线112连接并被推入插入导管111(见图11b)。在此阶段，插入导管使得减小了支架的直径，使得其可进入假体瓣膜与周围血管之间的空腔24内。图11c及图11d示出了植入瓣膜115，两个较大的硬化部位116产生了空腔117，其导致了血液返流并需要修复。(硬化仅是产生需要修复的空腔的状态的一个示例。由于其他原因也同样可导致空腔，其原因对本实施例并不起决定性作用。)图11e示出了插入导管111在导引线28上插入至导管的(输送)末端已通过空腔117的底部的位置。第一密封支架110在空腔117的底部下方展开。将导管111收回且缝线112部分收回，由此将第一密封支架110拉进空腔的底部，其容纳在该位置。参考图11f，插入导管111被收回直至其末端接近空腔24的顶部，在那里展开第二密封支架110。缝线112被进一步收回，由此将第二支架拉入空腔的顶部中，其容纳在该位置。上述处理的最终步骤是在位置119断开缝线的近端部分。
图12示出了根据本发明的优选实施例适于密封瓣膜周围渗漏的瓣膜。瓣膜121保持在保持支架124中，其中密封元件120围绕支架124的外表面周向附装。当将瓣膜121植入时，密封元件120扩展以密封周边的任何瓣膜周围渗漏。可以使用一些装置来实现密封元件120的扩展。在图12所示的实现中，密封元件120通过操作者使用注射器123来膨胀，且其构成气球状部分，该部分由诸如聚亚安酯的柔顺生理可接受聚合物材料制成。膨胀媒介可以是盐溶液、患者的血液、或其他生理可接受流体。
或者，密封部分可由与流体接触时浸透流体并膨胀的材料制成。一旦插入身体，密封部分就与血液进行接触，由此其膨胀并密封空腔。
图13a至图13d示出了根据本发明的另一优选实施例适于密封瓣膜周围渗漏的瓣膜。图13a示出了可植入瓣膜124。支架125具有连接至其入口的密封组件126。密封组件126由多个活叶127构成，并扩展至比支架125的主要直径更大的直径，由此产生额外的密封行以防止瓣膜周围渗漏。图13b示出了瓣膜124的俯视图。密封组件126包括多个彼此独立、连接至瓣膜支架125的活叶127。每个活叶127都由弹性线131制成，在展开瓣膜之后，其使得活叶127向外伸展。活叶127由不渗透密封材料128覆盖。布置活叶127使得其大体垂直于支架124的纵向轴线并彼此重叠，由此确保完全密封。
图13c示出了安装有支架的瓣膜124处于其卷曲形态。引入护套管130保持卷曲在气球129上的支架125及密封组件126。在展开之后，密封组件126的活叶127打开至其最终直径。
图13d示出了自扩展密封活叶127的横截面。支架支柱133通过诸如铆钉、螺纹部等机械附装装置134被附装至弹性线环131。弹性线环131可折叠在图13c所示的引入护套管130内，当从管130释放时，其回弹至其图13d所示的形状。
图14示出了根据本发明的另一优选实施例适于密封辩膜周围渗漏的瓣膜。该设计包括气球充气支架140(容纳括假体瓣膜)及气球充气密封环145，其类似于图13的密封组件126，只是在这里使用了气球充气线145而未使用弹性线环131。支架140使用两个气球来充气。第一气球部分142将支架140充气至所需直径，然后第二气球部分143将垂直于支架140的密封活叶145充气，由此产生较大的直径并由此密封支架周围的任何空腔。
图15a及图15b示出了根据本发明的另一优选实施例的适于密封瓣膜周围渗漏的瓣膜。在该实施例中，密封环包括柔性密封元件150。每个密封元件150都独立地弹性致动。当瓣膜卷曲时，密封元件150折叠，使得瓣膜可减小至较小直径以插入。当瓣膜扩展至其最终直径时，密封元件150打开至较大直径154以密封瓣膜周围的空腔，由此防止瓣膜周围渗漏。因为每个密封元件150是独立的，故邻近自然瓣膜组织152的密封元件保持闭合。这些闭合的元件提供了增加压力从而改进瓣膜的锚定的进一步的优点。
图16a至图16c示出了根据本发明的另一优选实施例的适于密封瓣膜周围渗漏的瓣膜。这里，密封环165至少包括多个连接至支架160的外表面的柔性自扩展密封元件165中的一个。类似于图15所示的实施例，当将支架160压靠在自然组织上时，密封元件165将保持压靠壁面。在如果在支架160与周围组织之间存在缝隙，则密封元件165将扩展并阻止任何可能的渗漏。参考图16b，密封元件165由覆盖有PET(聚对苯二甲酸乙二醇酯)栅网167或其他不渗透材料的自扩展栅网166制成。
图17a至图17e示出了根据本发明的另一优选实施例的适于密封瓣膜周围渗漏的瓣膜，其中在支架支柱的环172内设置有密封组件。在附图中，支柱172的环位于支架的入口处，但是，支柱的环也可在沿支架的其他位置处实现。包括支柱172的环的改变的支柱173设计使得其几何结构上被约束，使得在支架从卷曲状态(图17a)扩展至扩展状态(图17b)时，支柱172的环折弯至实质大于扩展支架的其他部分的最终直径168的最终直径169，由此密封瓣膜周围空腔及相关的渗漏。
图17c及图17d示出了关于改变的支柱173中的几何结构约束使得位置175位移从而产生扩大的直径169的正视图及侧视图。图17c示出了支架扩展之前与支架壁的其它部分对准的改变的支柱173。图17d示出了在支架扩展之后的改变的支柱173，其已经使得改变的支柱173升起并升出，由此产生密封环。图17e示出了几何结构约束的操作细节：当支架170卷曲时，支柱腿部彼此相对接近176，使得支柱高度相对较大177。在扩展之后，支柱腿部进一步远离间隔176a，从而导致位置175的位移，并由此减小了支柱的高度177a。位置175位移的结果在图17c、图17d及图17e中示出。如图17c及图17e的左侧所示，当支架卷曲时，位置175较低。如图17e的右侧所示，当支架扩展时，位置175向上移动，从而将支架拉至图17d所示的形状。
图18a至图18e示出了根据本发明的另一优选实施例的适于包括密封瓣膜周围渗漏的装置的瓣膜。在图18a中，卷曲在气球182上的经皮瓣膜180示出为朝向狭窄主动脉瓣膜175前进。多个缝线181中的至少一者在入口端187连接至瓣膜180。缝线沿气球的杆183向后伸展并沿布置通道持续向后并如图18b所示离开患者的身体。
如图18c所示，充气气球183在缝线181围绕其布置的情况下将瓣膜185锚定在环面179中。在存在瓣膜周围空腔178的情况下，可以通过缝线181的辅助将其修复。图18d示出了插在缝线181上并通过推入导管190被推至渗漏空腔的由心包膜(或其他合适的修复片材料)制成的修复片189。在修复片布置到位后，使用打结或夹子191来将其固定，由此修复渗漏(18e)。
图19a至图19d示出了根据本发明的另一优选实施例的适于包括密封瓣膜周围渗漏的装置的瓣膜。第一弹性密封支架195插入所需位置。然后，瓣膜196插入密封支架195。图19a示出了插入导管191，其上安装有密封支架195及瓣膜196。密封支架195及瓣膜196可如该附图所示为气球充气型，或为自扩展型(这会需要引入护套)。
图19b示出了布置在自然主动脉瓣膜中的两个支架。密封支架195补偿不规则形状，同时安装在密封支架195中的带支架瓣膜196可以为完全圆形。密封支架195能够避免由空腔或不规则形状(如上所述由硬化块导致)导致的渗漏。密封支架195的密封部件可为自扩展吸水海绵197(图19c)或其他合适材料。密封支架195可包括钩198，当支架插入时钩打开，由此改进了支架在环面中的锚定，并通过阻塞血液改进了围绕支架的密封(图19d)。
图20a示出了根据另一优选实施例的带支架瓣膜201，其具有沿内部区域的瓣膜结构202及沿外部区域用于密封瓣膜周围渗漏的机构。在该实施例中，柔性密封元件203提供了密封环。密封元件203可由任何适于植入人体的材料(例如，海绵材料)制成。当带支架瓣膜201卷曲至较小直径时，密封元件203也卷曲，由此使得瓣膜可容易地推进至治疗位置。为了说明的目的，图20f示出了卷曲之前的密封元件203，同时图20g示出了处于卷曲状态的密封元件。当瓣膜扩展至其最终直径时，密封元件203通过内部弹性力及/或通过吸收血液而扩展至其原始尺寸直径。密封元件的扩展密封了围绕瓣膜的空腔，由此防止了瓣膜周围渗漏。除了阻止空腔的机械效果之外，血液蛋白优选地附着至密封元件，由此形成凝结物以进一步防止渗漏。图20c及图20d提供了优选密封元件的横截面图。图20c所示的管状物203a构造为卷曲至比图20d所示的杆状物203b更小的尺寸。图20e示出了密封元件具有附加纤维206，其增加了活性表面，由此增加了蛋白附着效果并由此改进了凝结及密封。图20e还示出了缝线207作为用于附装至瓣膜主体的一个优选方式。图20b是示出具有密封机构的瓣膜210的另一优选实施例的立体图。在该改变示例中，沿外部区域设置有两个密封元件204，205。
图21示出了适于密封瓣膜周围渗漏的另一带支架瓣膜220。在该实施例中，密封元件223(优选地由以上针对20a至20g描述的相同材料制成)通过非直线密封线附装至支架。在优选结构中，密封线可邻近瓣膜结构222至支架的连接或根据支架结构的线。根据一个特征，可以利用示出的附装线实现改进的卷曲轮廓。
图22示出了构造为减小或防止瓣膜周围渗漏的另一带支架瓣膜250。该带支架瓣膜大体包括支撑瓣膜结构254的可扩展支架结构252。支架结构252优选地由诸如不锈钢的可形变材料制成，适于利用气球导管径向扩展。瓣膜结构254形成三个叶瓣并示出为打开结构。
为了减小或防止瓣膜周围渗漏，将可压缩材料层256沿支架结构252的外表面布置。该材料可部分围绕支架结构延伸或可整体围绕支架结构延伸，例如呈套筒形式。在一个优选实施例中，可压缩材料由聚对苯二甲酸乙二醇酯(PET)形成，并具有从约1mm至5mm范围的厚度。在特定的结构中，可压缩材料256可类似于具有从材料表面延伸的小纤维的布料或织物。在其他实施例中，纤维可以是直的、弯曲的、或钩状。在布置在治疗位置之后可压缩材料扩展。随着可压缩材料的扩展，其填充带支架瓣膜与周围组织之间的缝隙。因此，可压缩材料产生防止瓣膜周围渗漏的机械密封。此外，可压缩材料(特别是纤维)可适于促进血液凝结以进一步填充缝隙并防止渗漏。在替换结构中，组织生长因子可施加至压缩材料用于促进组织生长到材料中，由此进一步密封缝隙。可以使用任何合适的组织生长因子。在各种优选方法中，可以沿可压缩材料的外表面施加生长因子，或者在使用之前可在生长因子中浸透或浸湿该材料。
在另一实施例中，生物适应的水凝胶可涂抹至假体瓣膜的外表面。在展开之后，水凝胶吸收来自血液的流体，并膨胀以填充瓣膜与周围组织(例如，主体环面)之间的缝隙。在优选方法中，水凝胶可在展开之前或在展开之后被涂抹至带支架瓣膜的表面。
前述具体实施例是对本发明的实践的说明。但是，需要理解的是，可以采用本领域技术人员公知或这里揭示的其他手段而不脱离本发明的精神或所附权利要求的范围。

Claims (29)

1.一种用于定位在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送装置，所述空腔在心舒张期间产生瓣膜周围渗漏，所述装置包括多个柔性线中的至少一者，所述线附装有气球，其中所述气球由所述渗漏拉动通过所述空腔，且其中所述线于是用于标记所述空腔位置。
2.如权利要求1所述的装置，还包括分隔元件，其维持邻近所述体管的所述壁的所述线。
3.一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送支架，所述空腔在心舒张期间产生瓣膜周围渗漏，所述支架通过导引线输送至所述空腔，通过摩擦在所述空腔中保持在位，并包括支撑结构及不渗透薄膜，所述薄膜防止流体通过所述支架，由此密封所述空腔。
4.如权利要求3所述的装置，其中所述密封支架为气球充气型，且所述薄膜包括弹性铰接至所述支架管腔的内部并确定尺寸以在关闭时阻塞所述管腔的突片，所述突片在插入期间通过所述支架气球保持打开，并在所述支架扩展后当所述气球移除时回弹关闭。
5.如权利要求3所述的装置，其中所述密封支架可自扩展，其中所述薄膜是覆盖所述支架的至少一端的材料。
6.如权利要求5所述的装置，其中所述支架由形状记忆材料制成。
7.如权利要求6所述的装置，其中所述材料是镍钛诺。
8.如权利要求5所述的装置，还在其外壁上覆盖有由形状记忆材料制成的钩，所述钩在所述支架插入时延伸进入邻近的体管壁。
9.如权利要求3所述的装置，其中所述支架输送导管的末端在所述空腔内部一点处大体垂直于所述管壁，且所述支架导引线以锚定机构终止，该锚定机构插入通过所述导管并进入所述管壁，由此将自身锚定在所述管壁中并为所述支架提供更大的锚定力。
10.如权利要求9所述的装置，其中所述锚定机构是由形状记忆材料制成的钩，所述钩收缩用于导管输送进入所述管壁，在该位置所述钩伸出，由此将所述导引线锚定进入所述管壁。
11.如权利要求10所述的装置，其中所述锚定机构是拧入所述管壁由此将所述导引线锚定进入所述管壁的螺纹部。
12.一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的装置，所述空腔在心舒张期间产生瓣膜周围渗漏，所述装置包括穿线通过所述空腔的第一导引线、滑动地耦合至第一线并被插入使得所述可滑动耦合移动至所述空腔内的位置的第二导引线、在所述第一导引线上插入到达所述空腔内的位置的第一导管、在所述第二导引线上插入到达所述空腔内的位置的第二导管、通过所述第一导管插入到达所述位置的双组分生物粘合剂的第一组分、通过所述第二导管插入到达所述位置的双组分生物粘合剂的第二组分，且所述两种组分由此混合以形成密封所述空腔的栓。
13.如权利要求12所述的装置，其适于施加具有多于两种组分的粘合剂。
14.如权利要求12所述的装置，其中使用单个导管及导引线替代两个导引线及两个导管用于输送，其中所述导管具有两个管腔，每个管腔都提供用于所述双组分粘合剂组分其中一者的输送，所述导管终止在混合器中，当离开所述导管进入所述空腔时，所述混合器迫使所述组分混合，由此产生密封所述空腔的栓。
15.如权利要求12所述的装置，其中通过所述导管中的一者输送射线固化粘合剂并通过另一导管输送射线源，来替代通过所述导管输送双组分粘合剂组分，其中所述射线源被施加至所述粘合剂以在所述空腔内产生所述栓。
16.一种用于密封在假体瓣膜与瓣膜植入处的体管的壁之间产生的空腔的导管输送装置，所述空腔在心舒张期间产生瓣膜周围渗漏，所述组件通过导引线输送至所述空腔，并包括通过缝线连接的两个密封支架，所述缝线向上返回所述导管，所述密封支架包括支架结构及密封薄膜，所述组件的一个支架插入到所述空腔之下而另一支架插入所述空腔内部，所述薄膜防止流体通过所述支架，由此密封所述空腔且每个支架均有助于将另一支架锚定到位。
17.一种假体瓣膜，具有附装至外壁的集成密封环，所述环具有大于所述瓣膜的外周，并弹性地适形以密封所述瓣膜与所述瓣膜植入处的体管的壁之间的空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
18.如权利要求17所述的装置，其中所述环包括气球。
19.如权利要求17所述的装置，其中所述环包括多个弹性线突片，所述突片围绕所述瓣膜的外周彼此邻近安装，并由不渗透薄膜覆盖，且其中在导管输送期间所述突片抵靠所述瓣膜的主体折叠，且当离开所述导管时，所述突片回弹以形成所述密封环。
20.如权利要求17所述的装置，其中所述环包括多个围绕所述瓣膜的外周彼此邻近安装的不渗透突片，并还包括所述突片下方的气球，且其中所述突片在导管输送期间向下折叠在放气气球上，且其中当离开所述导管时，所述气球充气，由此打开所述突片以形成所述密封环。
21.如权利要求17所述的装置，其中所述环包括多个围绕所述瓣膜的外周彼此邻近安装的不渗透突片，每个突片都弹性铰接至所述瓣膜，且其中在导管输送期间所述突片抵靠所述瓣膜的主体折叠，且当离开所述导管时，所述突片回弹出去以形成所述密封环。
22.如权利要求17所述的装置，其中所述环包括多个柔性自扩展密封元件中的至少一者，所述密封元件由被不渗透薄膜覆盖的自扩展栅网构成。
23.如权利要求17所述的装置，其中所述环包括多个柔性自扩展密封元件中的至少一者，所述密封元件由被不渗透薄膜覆盖的自扩展栅网构成。
24.如权利要求17所述的装置，其中所述密封环包括所述支架的改变支柱，改变包括几何结构约束，当所述支架扩展时，该几何结构约束使得所述支柱折弯离开所述支架主体，由此产生所述密封环。
25.一种具有集成的密封装置的假体瓣膜，所述密封装置包括围绕所述瓣膜的外周附装并向后延伸离开身体的缝线，且其中修复片可被推至所述缝线之下，并被附装至缝线附装至所述瓣膜的位置，由此密封在所述瓣膜与瓣膜植入处的体管的壁之间存在的任何空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
26.一种具有集成的密封装置的导管输送假体瓣膜，所述密封装置包括首先被展开且瓣膜在其中展开的弹性支架，所述弹性支架密封在所述瓣膜与瓣膜植入处的体管的壁之间存在的任何空腔，所述空腔在心舒张期间产生瓣膜周围渗漏。
27.一种用于植入在体管内的假体瓣膜，包括：
构造用于径向扩展的大体筒状的支架结构；
提供具有入口及出口的柔性管的瓣膜结构，所述瓣膜结构由附装至所述支架结构的柔顺材料形成，并形成三个瓣膜叶瓣；
可压缩材料层，其沿所述支架结构的外表面布置，所述可压缩材料适于在展开之后扩展以填充所述假体瓣膜与所述体管之间的缝隙。
28.如权利要求27所述的假体瓣膜，其中所述可压缩材料由聚对苯二甲酸乙二醇酯制成。
29.如权利要求28所述的假体瓣膜，还包括沿所述可压缩材料布置的组织生长因子，且其中所述可压缩材料包括多个从所述外表面向外延伸的纤维。
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US20070293944A1 (en) 2007-12-20
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CN101849863B (zh) 2012-08-29
WO2006005015A2 (en) 2006-01-12

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