CN1440261A - 瓣环成形设备 - Google Patents

瓣环成形设备 Download PDF

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CN1440261A
CN1440261A CN01812371A CN01812371A CN1440261A CN 1440261 A CN1440261 A CN 1440261A CN 01812371 A CN01812371 A CN 01812371A CN 01812371 A CN01812371 A CN 01812371A CN 1440261 A CN1440261 A CN 1440261A
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equipment
valve
ring
fastening
lobe
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CN1208032C (zh
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马克·奥尔蒂斯
兰迪·惠登
保罗·A·斯彭斯
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Medtentia AB
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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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • A61F2210/0023—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 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
    • A61F2210/0033—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 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply electrically, e.g. heated by resistor
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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

在各种实施例中用于修补和置换心脏瓣膜(18)的设备(42)，设备(42)包括以线圈状结构相连接的至少第一和第二支撑环，所述支撑环紧靠在瓣环(20)相对两侧面。该环状设备(262)可以保护置换瓣膜(260)。不同的紧固系统包括缝合紧固系统、机械紧固系统、形状记忆合金紧固系统和其它仅依靠相邻线圈间的弹性的紧固系统。方法一般是将该环状设备(42)的第一端插入并穿过瓣环(20)，通过旋转将该设备的第一支撑环放到瓣环(20)的一侧面的位置上，同时将该至少设备(42)的第二支撑环放到瓣环(20)相对另一侧面的位置上。

Description

瓣环成形设备
技术领域
本发明涉及心脏瓣膜修补和置换技术以及瓣环成形设备。进一步地说，本发明涉及患有畸形及功能障碍的心脏瓣膜的修补和/或置换。
背景技术
患病的二尖瓣和三尖瓣瓣膜往往需要进行修补或替换。二尖瓣和三尖瓣瓣膜的瓣叶或支撑腱索功能的恶化或瓣环扩大将导致瓣膜关闭不全(闭锁不全)，瓣叶和腱索的钙化增厚将致使它们变狭窄(前行血液受阻)。瓣膜最终依靠心室中腱索的牵拉，如果心室形状改变，瓣膜支撑功能的丧失会导致瓣膜关闭不严。
二尖瓣和三尖瓣瓣膜的置换和修补一般采用缝合术。在瓣膜置换时，缝线沿瓣环缝合(即瓣叶与心脏连接处)，然后连接到人工瓣膜上。人工瓣膜向下放到位，当缝线扎紧时瓣膜就缝紧在瓣环上。在插入人工瓣膜之前，外科医生会切除全部或部分瓣叶；进行瓣膜修补时，对病变瓣膜进行外科手术以重建瓣膜功能。通常使用瓣环成形环减小瓣环的大小。该成形环用于减小瓣环的直径，并每个使瓣叶正常相对。缝线用于将人工环连接在瓣环上，并有助于折叠瓣环。
一般来说，瓣环成形环和置换瓣膜必须缝合到瓣环上。这一步最为耗时和漫长。如果瓣膜成形环出现严重的位置不正，就必须拆除缝线，在重新缝针时将成形环重新放置在瓣环上。有些情况下，外科医生宁愿容忍不太合适的瓣环成形也不愿延长手术时间重新缝合成形环。
该心脏外科手术的重点在于减少置换和修补瓣膜的时间，因为心脏往往处于停止跳动和无灌注的状态下。使用一种有效的方法将人工瓣膜连接到二尖瓣或三尖瓣瓣膜的位置上是非常有用的。此外，该方法在遥控连接瓣膜修补或置换设备时有显著作用，可以完全避免进行外科手术。
因此，有必要提出一种更可靠和更容易完成瓣膜修补和置换的瓣环成形设备、方法以及瓣膜修补和置换设备及技术。
发明内容
本发明提出了一种用于心脏瓣膜修补的设备，该心脏瓣膜具有瓣环和多个瓣叶，允许和防止血液流过患者心脏。该设备包括第一支撑环和第二支撑环，第二支撑环与第一支撑环连接形成线圈状结构。第一支撑环安放到紧靠瓣环的一侧面的位置上，第二支撑环安放到紧靠瓣环另一相对侧面的位置上，从而夹紧瓣膜组织，即瓣环组织和/或瓣叶组织。例如，该器件可用于常规使用瓣环成形环的情况下，但本发明的设备的使用更为简单。此设备也可用于支撑置换的心脏瓣膜。本发明设计了该设备不同的具体实施例，包括基于导管外科手术的设备和开胸外科手术的具体设备。
在不同的具体实施方案中，第一和第二支撑环带有外层覆盖的内芯，该外层例如是织物层，内芯由比外层坚硬的多的材料制成。第一和第二支撑环的横截面通常呈三角形，相对面为平面，可夹住瓣膜组织。在两个支撑环间可使用多种紧固器件，包括尖的突状物。可使用致动元件将紧固设备穿过瓣膜组织固定在位置上。也可以使用其它紧固设备如在第一和第二支撑环上的突状物和接收组件。可以使用形状记忆合金以便于连接，如通过同时移动第一和第二支撑环或移动紧固组件将其接合。
相对的第一和第二支撑环的表面至少有一个是粗糙的，可通过使用织品材料、涂层、突起或类方法处理。粗糙的表面易于将支撑环连接并固定在瓣膜组织上。第一和第二支撑环可携带一个可除去式套管用于在初始接合阶段——如支撑环在瓣环的任一面旋转时——减小每个支撑环和瓣膜组织的摩擦，然后撤走套管，露出支撑环粗糙度较高的表面以更好的紧固瓣膜组织。
优选的是，第一和第二支撑环由一个线圈状细丝，如金属丝，整体制成，一端做头，一端做尾。两端按相对方向弯曲，前端指向瓣膜组织，尾端由合适的外科手术器械抓住。使用运载工具将该设备旋转到瓣环两面相对的位置上，撤走运载工具使放到位的第一和第二支撑环夹住瓣膜组织。另一种做法和传统的瓣环成形环类似，运载工具是线圈形的，可以只将修补设备旋转到瓣膜的一面，旋转并撤除运载工具的同时使修补设备放到位。第一和第二支撑环可以调整直径的大小以进行瓣环的调整。
当进行心脏瓣膜的置换时，本发明的一种设备最好包括第一和第二支撑环以线圈结构，置换瓣膜至少和支撑环之一相连。可以使用任何适合的紧固结构用可拆线的方法连接置换瓣膜。例如：置换瓣膜和一个支撑环可能带有配套接合器件，或置换瓣膜可直接在支撑环之一上穿线。置换瓣膜和一个支撑环两者中有一个带有套筒，用于接受缝线将置换瓣膜固定在支撑环上。两个支撑环中的任意一个可带有套筒，带有可移动式的紧固元件可与置换瓣膜相接合。该紧固元件可由形状记忆合金制成，便于其在相应的置换瓣膜的啮合与非啮合位置间的移动。
本发明进一步设计了心脏瓣膜修补的不同方法，包括心脏瓣膜完全置换的方法。一般来讲，此方法包括：将一个线圈形支撑的第一端插入并穿过心脏瓣膜组织。此线圈形支撑的第一环旋转到瓣环的第一侧面的位置上，线圈形支撑的第二个环放在瓣环的相对侧面的位置上。紧固第一和第二支撑环以夹紧瓣环间的组织，或利用第一和第二支撑环间的弹性而不使用紧固器来夹紧瓣环间的组织。在旋转步骤中，可以利用其线圈的形状传送此线圈状支撑环，或使用接近瓣环的导管伸出此线圈状支撑。本文公开的基于常用技术的这些方法及其附加方法明显可产生许多其它变化。
通过下面的详细描述，对于本领域的普通技术人员可以很清楚地了解本发明的其他目的、优点和特点。
附图的简要描述
图1所示为一患者心脏的截面简图，显示了做为支撑二尖瓣瓣膜的本发明的一种设备。
图1A所示为左心室截面图，显示了二尖瓣瓣膜和本发明的一种带有套管的设备的透视图。
图2A所示为二尖瓣瓣膜和此带有导管的设备在插入过程中的部分截面透视图
图2B与图2A相似，显示了该设备完全插入二尖瓣瓣膜以下。
图2C与图2B相似，但显示的是该设备已完全连接在二尖瓣瓣膜上。
图3为图2C的横截面图示。
图4为该瓣膜修补设备的另一实施例的横截面图示。
图5A的部分横截面视图显示了一段本发明设备的一种紧固系统。
图5B的横截面视图与图5A相似，但显示的是紧固系统和瓣膜组织的接合。
图6的横截面视图与图5B相似，但显示了另一种紧固系统和瓣膜组织的接合。
图6A为一段带有套管的瓣膜修补设备的横截面视图。
图6B显示了一段图6A中所示的设备插入到心脏瓣膜中的放大横截面视图。
图7是另一种心脏瓣膜修补设备的透视图。
图8是另一种处于非激活状态的瓣膜修补设备的透视图。
图9为图8所示设备的透视图，但处于激活状态。
图10所示为心脏瓣膜修补设备的另一实施例的部分透视截面图。
图11所示为图10中设备的一段放大截面图。
图12是另一种心脏瓣膜修补设备的透视图。
图13是图12中画圈部分12A的放大视图，分开显示线圈。
图14的透视图显示了将本发明的一种心脏瓣膜修补设备应用于二尖瓣瓣膜。
图15的透视图与图14相似，但显示了此设备的前端插入瓣环中。
图16的透视图与图15相似，但显示了此修补设备已完全作用于瓣膜上。
图17为图14中沿17-17线的横截面图。
图18A为图16中沿18-18线的横截面图，显示了本发明的一种紧固系统处于非激活状态。
图18B的横截面图与图18A相似，但显示的是处于激活状态的紧固系统。
图19俯视图为本发明的一种设备，用于三尖瓣瓣膜的修补。
图20透视图为本发明的另一种设备，用于二尖瓣瓣膜的修补。
图21与图20相似，但显示了两个该设备应用于二尖瓣瓣膜上。
图22为本发明的另一种心脏瓣膜修补设备的部分透视图。
图23为另一种心脏瓣膜修补设备的透视图。
图24为另一种心脏瓣膜修补设备的透视图。
图25的部分横截面图显示了本发明的瓣膜修补设备的另一种紧固系统。
图26为本发明的一种心脏瓣膜置换设备的分解透视图。
图27为另一种心脏瓣膜置换设备的横截面图示。
图28为另一种心脏瓣膜修补设备的部分截面视图。
图29为另一种心脏瓣膜修补设备的平面视图。
图29A为图29所示修补设备的一种横截面视图。
图29B的横截面视图与图29A类似，但显示了另一种结构。
图30为本发明设备的一种紧固系统结构的横截面视图。
图31的透视图显示了另一种用于二尖瓣瓣环的心脏瓣膜修补设备。
图32为图31所示设备的侧视图，显示了该设备将沿着二尖瓣瓣环使用。
图33的横截面视图为另一种本发明的线圈状修补设备的结构。
图34A为另一种心脏瓣膜修补设备的截面透视图。
图34B为图34A所示设备的横截面视图，显示了与瓣膜组织的连接。
图35A的横截面视图与图34B类似，但显示了另一种紧固系统。
图35B的横截面视图与图35A类似，但显示了修补设备已紧固在瓣膜组织上。
图36的侧视图显示了本发明的另一种心脏瓣膜置换设备。
图37的侧视图与图36类似，但显示了置换瓣膜已完全与线圈状支撑设备连接。
图38是另一种心脏瓣膜修补设备和二尖瓣瓣膜的顶面视图。
图39A～D简图显示了根据本发明另一实施例的置换瓣膜过程的步骤。
图40为另一种心脏瓣膜修补设备的横截面视图。
图41A和42B的横截面视图显示了使用另一种瓣膜修补设备的步骤。
图42的横截面视图显示了另一种用于心脏瓣环的瓣膜修补设备。
图43的透视图显示了本发明的另一种心脏瓣膜置换设备。
优选实施方案的详细描述
图1所示为一患者10)的心脏12)的横截面视图，包括左心室14)和右心室16)。本发明的设计适合用于为左心室14)供血的二尖瓣瓣膜18)。二尖瓣瓣膜18)，如图1A所示，包括一个瓣环20)和一对瓣叶22，24)，瓣叶有选择性的防止血流进入左心室14)或为其供血。值得一提的是对于此图，本公开中广泛使用了术语“瓣环组织”一词，但是当提到其它瓣环组织如瓣叶组织或别的脉管组织时，本发明的原则也是同样适用的。
瓣叶22，24)由从每个乳头肌30，32)上面伸出的腱索26，28)支撑连接。血液通过二尖瓣瓣膜18)进入左心室14)，随后在心脏12)收缩时通过主动脉瓣膜34)排出。应该清楚的是本发明除了适合于以下所述的二尖瓣瓣膜的各个方面以外，也适用于其它心脏瓣膜。
本发明的一种优选设备如图2A-2C和图3所示，通过使用套管(40)，采用常规的如在股骨动脉中采用的技术，将该设备插入心脏中合适的位置，例如二尖瓣瓣膜(18)上。在套管(40)中以可活动的方式装入一种柔韧的、细长的支撑设备(42)，如图2A-2C所示，该支撑设备伸出来的时候呈螺旋状或钥匙环状结构。任何合适的医用级材料，如医用级金属或塑料，都可以用于制造此支撑设备(42)。该设备的一种类型，如图3的横截面视图所示，由外层(46)和其包围的内芯(44)和组成。内芯(44)由较硬的材料如金属或塑料制成，外层(46)的材料较软，如织品。另一种细长柔韧的支撑设备(42’)如图4所示，此设备具有一个像钥匙圈那样的横截面，其两个相对的平面(42’a)夹住了瓣环组织(20)。
如图2A所示，把套管(40)一直插到其开口处(40a)靠近瓣环(20)的位置，然后将支撑设备(42)伸过瓣环(20)并将其从套管(40)中推出，在二尖瓣瓣膜(18)下靠近瓣环(20)的地方，该设备呈预先弯好的线圈状，如图2B所示。图2C进一步显示了套管(40)从支撑设备(42)上撤走后，该支撑设备(42)的其它部分在二尖瓣瓣膜(18)上呈预先弯好的线圈状，从而使瓣环(20)被夹在支撑设备(42)的相邻线圈间。
图5A和5B显示了支撑设备42的结构，其内芯(44)包括可在伸出和缩回位置之间伸缩移动的倒钩(44a)。在图5A所示的缩回位置时，倒钩(44a)并没有与瓣环组织(20)接合。当内芯按照图5A箭头所示的方向拉动时，倒钩(44a)伸出外层刺入瓣环(20)中，这样就把柔韧细长的支撑设备(42)固定在瓣环(20)上。图6显示了另一实施例的柔韧细长的支撑设备(42”)。在该实施例中，内芯(44”)中包含的倒钩(44a”)可在按箭头所示方向拉动内芯时，从相对的方向刺入瓣环(20)中，更易于设备的稳固。
图6A和6B显示了套管(40)和内芯(44)的横截面以及一种致动设备(60)的简图。明确地说，该设备的一对钳夹(62，64)通过枢轴紧固在一起，通过拉索(66，68)拉紧内芯(44)的一端(44b)可使钳夹在开和关的位置上活动。外科医生可以沿合适的方向通过推或拉使倒钩(44)(图5A中所示)处于伸出或缩回的位置。
图7显示了另一实施例的线圈状柔韧细长的支撑设备(52)，换句话说，呈钥匙环状的支撑设备。在该实施例中，单独的固定组件(54)可通过各自的孔(56)将支撑设备(52)的环面固定在瓣环组织上(未显示)。固定组件(54)可以是螺纹栓或无螺纹栓，其直接与支撑组件(52)接合在一起，在锁定或开锁位置间活动可以夹紧或放开瓣环组织。
图8和图9显示了另一实施例的线圈状支撑设备(70)，其包括互锁部分(70a，70b)。例如，该支撑设备可以按照与图2A-2C所述类似的方法插入，一旦插到瓣环相对的两面，该线圈状支撑设备(70)就可以激活处于锁定的位置，如图9所示。此支撑设备(70)可由形状记忆合金制成，通过使用合适的电流使其处于图8所示的解锁位置或图9所示的锁定位置。
图10和图11显示了另一种线圈状瓣膜支撑设备(80)，也是由一层带有柔韧的织物材料的外层(82)和其包围的内芯(未显示)组成的。由于采用这样的结构，外层(82)产生的摩擦力可能会使支撑设备(80)的插入——特别是在只用手动的方法将该设备(80)放到下述位置的情况下——变得十分困难。因此，在该支撑设备(80)的外面提供了一个套筒(84)，套筒(84)由低摩擦力的材料如PTFE或特氟隆(Teflon)制成。这样低摩擦力会使支撑设备(80)的插入变得容易的多，只需将该线圈状的支撑设备(80)旋转穿过瓣膜(20)上的裂口或孔，放到合适位置上即可。一旦如图10所示支撑设备(80)插入后，就可以脱掉其套筒(84)。另外的方法是，套筒(84)是一层包衣(涂层)，可以在插入后被吸收或洗掉。
图12和图13显示了另一种线圈状或钥匙环状的瓣膜支撑设备(90)。该设备的紧固设备(92)也采用如图7所述的螺纹紧固器。图13清楚地显示了该线圈状支撑设备(90)的相对的表面应用了一层柔软的垫状材料(94，96)，可以与瓣膜(未显示)接触。除了为与瓣膜接触的区域提供缓冲作用外，覆层(94，96)还可以提供额外的摩擦力固定支撑设备(90)。可以再次使用图10和图11中所述的低摩擦力套筒(未显示)使其(90)轻易地插入瓣膜上下方。
图14-16显示了另一种按本发明制造的线圈状支撑设备(100)的安放过程。在环之间连有一临时托架102，其带有一个把手(104)，可以沿一大体由把手104长度方向限定的中轴旋转该线圈状支撑设备(100)。如图14所示，在瓣环(20)上开一个切口(106a)或小孔，将该支撑设备(100)的前端(100a)穿过切口(106a)，如图15所示。旋转把手(104)直到一圈在瓣环上，一圈在瓣环下夹住瓣环组织(20)，如图16所示。
图17和18A-18B显示了图14-16所示设备使用的另一种锁定结构。这种结构中，可以拉动一条芯线(110)并利用一种凸轮机构(112)推动连在载体(116)上的一串倒钩或其它紧固设备(114)穿过瓣环组织(20)，刺入另一面柔软的涂层(118)上(如硅树脂涂层)上，然后可以切断心线(110)或将之打结以防止其向相反方向移动。这样，该凸轮机构(112)就将倒钩或其它紧固设备(114)固定到位，如图18B所示。
图19显示了一种为三尖瓣瓣膜(122)特别制造的瓣膜支撑设备(120)，其还可以被形成为在此所讨论的线圈，包括此处所述的内芯和紧固设备(124)。
图20和图21显示了了一种C形支撑设备(130)，包括相连接的第一和第二腿夹(130a，130b)，可以将瓣膜，如二尖瓣瓣膜(18)的两面锁定，如图21所示。每个C形瓣膜支撑设备(130)通过切口(134)插入，使腿夹(130a，130b)夹住图20所示的瓣环组织(20)，使用内芯线(136)致动前述的锁定机构(未显示)。
图22显示了另一种用于C形瓣膜支撑设备(140)的锁定机构。该设备中，相对的两个腿夹(140a，140b)相向移动，使锁定设备或倒钩(142)与瓣膜组织(未显示)接合，然后由外科医生去掉把手或活动部分(144，146)。
图23显示了一种活动式套筒(150)，可用于一个线圈状的瓣膜支撑设备的较为坚硬的部分(152)。
图24和图25显示了另一种锁定机构，可用于本发明的线圈状瓣膜支撑设备。在该机构中，拉动支撑设备(162)的内芯(160)促使一种柔韧的倒钩设备(164)穿过瓣环组织(20)，刺入相对的一面(170)呈砧骨部分(168)，这有效地将倒钩设备(164)在砧骨部分(168)中锁定为钩状，如图25所示。这样就提供了一种更为有效的锁定。
图26显示了本发明的另一个实施例的线圈状支撑设备(180)。一旦该支撑设备(180)沿着人体瓣环转动并固定好，就可以将一种置换的心脏瓣膜(182)安放到位。切除人体二尖瓣瓣膜(18)或其它瓣膜，将置换的瓣膜(182)锁定在此线圈状的支撑设备(180)上。该置换的心脏瓣膜可以按本发明进行设计，也可以是常规使用的瓣膜，其包含不同的连接设备可在瓣膜(182)和支撑设备(180)之间连接。图26所示的具体设备中，连接器件是瓣膜(182)上的凸起物(186)，可以卡在支撑设备(180)的凹槽部分(190)。凸起物(186)插进每个凹槽(190)的一端(190a)，并旋转到图中所示凹槽的另一端(190b)固定好。图27显示了一种类似的置换瓣膜(192)，带有活动式的阀瓣194，196。瓣膜(192)外部的环状部分(198)有凸形的外表面(198a)，该表面(198a)一开始就可以缝在支撑设备(200)上，这样就能固定在人体瓣膜(202)的上面，如图中所示。
图28显示了另一种紧固方法，可以将一种置换心脏瓣膜(210)固定在一种按本发明设计的线圈状支撑设备(212)上。具体来说，该置换用的心脏瓣膜(210)带有一个由织品制成的套管(214)，线圈状的支撑设备(212)也带有一个织物材料的套管(216)。外科医生通过在套管(214，216)间缝线将置换瓣膜(210)缝到位置上，然后将缝线拉紧，将套管接合在一起形成封口。
图29和图29A显示了另一种用片状材料，如金属或塑料制造的线圈状支撑设备(217)。图29B显示的线圈状支撑设备(218)也是由一种片状材料，如金属或塑料制成的，一边是平面的线圈(218a)，相邻的另一边是波浪形的线圈(218b)。
图30显示了另一种夹在二尖瓣瓣膜(18)的瓣环(20)上的线圈状支撑设备(219)，具有一种独特的横截面结构。具体来说，上部的线圈是凹形的(219a)，下部的线圈是凸形的(219b)，可以卡进凹槽(219a)中，夹住瓣环组织(20)。对于夹住多余的瓣环组织，该设备较为理想。
图31和图32显示了一种线圈状支撑设备(220)的改进，该支撑设备(220)可紧固瓣膜(如二尖瓣瓣膜(18))上的瓣环(20)。具体来说，该线圈状支撑设备(220)的每一端可以相对弯曲，前端(220a)变尖，易于插进瓣环上的小孔(222)里；另一端(220b)上翻，医生可以使用合适的工具(224)夹住将支撑设备(220)沿瓣环(20)放到位。
图33显示了一种线圈状支撑设备的一个线圈(226)的另一种横截面视图。具体来说，线圈(226)的内芯(228)由低摩擦的材料如低摩擦力聚合物组成，当如前所述将线圈(226)旋转到位时，低摩擦表面(228a)面对与瓣环组织(未显示)接合的一面，外层(228b)由一层适合的织物(230)包覆，织物(230)可以是瓣环成型环上常用的织物。使用合适的钉或销(232)或其它紧固方法将织物层与内芯连接起来。
图34A和34B显示了另一种线圈状支撑设备(240)的横截面视图，该设备由金属或坚硬塑料制成的一个中空的外层载体(242)和其容纳的内芯部分(244)组成。此线圈状支撑设备(240)可如前所述安放在瓣环(20)的上下，其外层载体的位置如图34A所示，内芯(244)也呈线圈状，并在载体中偏离轴心，靠近其相邻的线圈内芯。当如图34B所示去掉中空的载体(242)时，内芯部分(244)弹到其初始位置，并用凸起物、钉或倒钩(248)将其固定在瓣环组织(20)上，如图34B所示。这些钉刺可以完全或部分穿过瓣环组织(20)。
另一种方法如图35A和图35B所示。具体来说，外层载体(242)内带有织物材料的内芯(250)。在载体(242)和内芯(250)沿瓣环(20)安放到位后，如图34A所示，用钉(252)穿过载体(242)上的孔(254)和瓣环组织(20)，刺入另一面织物材料的内芯(250)，如图35B所示。在钉(252)沿着整个瓣环插入后，去掉外层的载体242将内芯(250)固定在瓣环(20)的上下位置上，如图35B所示。
图36显示了一种置换瓣膜(260)插入一个固定在瓣环(20)上的线圈状的支撑设备(262)的情况。具体来说，置换瓣膜(260)的外部带有一个套筒(264)，可以套入支撑设备(262)的上部线圈(260a)并旋转到位，如图37所示。值得一提的是，该配对偶合套筒(264)和线圈(262a)可以颠倒过来，即线圈(262a)可以带有套筒，套入瓣膜(260)的线圈或环上。
图38显示了固定二尖瓣瓣膜(18)的另一种线圈状支撑设备(270)，其带有一条内部拉绳(272)，可按箭头(274)的方向拉动，减小支撑设备(270)的直径，从而相应减小了二尖瓣瓣膜(18)的直径，如箭头(276)所示。可以系住拉绳(272)将瓣膜(18)紧固在所希望的直径上。
图39A～39D显示了另一种线圈状支撑设备(280)。该实施例中线圈(280a，280b)至少是同心的，将支撑设备(280)穿过脉管(284)上的小孔(282)，使线圈(280a，280b)夹住脉管(284)。从图中可见，使用一个载体(290)将支撑设备(280)旋转到位置上，如图39A和39B所示。然后利用前述的紧固方法或其它合适的方法将一个置换瓣膜(292)固定在内部线圈(280)上，如图39C和39D所示。
图40显示了一种波浪形线圈状支撑设备(300)的横截面视图，该设备的相邻线圈(300a，300b)可夹住瓣环组织(20)。此支撑设备(300)的结构类似于前述的结构，其波浪形的结构进一步提供了一种紧固支撑设备(300)和瓣环组织(20)的方法。作为一种额外的紧固方法，线圈状的环上有一排小孔(302)，可让缝线(304)穿过整个或部分线圈(300)和组织(20)。
图41A和41B显示了另一种实施例，一个由金属或较硬塑料制成的线圈状设备(310)作为一个织物材料支撑设备(312)的载体。该织物材料的支撑设备(312)也可是线圈状的，并最终安放在瓣环(20)的两面，或像常规瓣环成形环那样放在瓣环(20)的一面。具体来说，该织物材料的支撑设备(312)可以临时缝在线圈状载体(310)上，将它们一同拐入瓣环(20)的上下位置。较低的线圈310a带有凹槽(314)，一(310，312)安放到图41A所示的位置时，用一排钉(316)穿过织物材料的支撑设备(312)，将该支撑设备(312)固定到瓣环组织(20)上，如图41B所示。当沿瓣环(20)插入必要数量的钉(316)后，就可以拆除临时缝线(未显示)去掉线圈载体(310)，使织物材料的支撑设备(312)留在瓣环(20)上。
图42显示了另一种心脏瓣环置换设备(330)，其由一对阀瓣(332，334)及一个环状支撑设备(336)组成。在此处显示的置换瓣膜可能有不同的类型。一种与前述的线圈状修补设备相似的线圈状设备(340)沿瓣环(20)固定。具体来说，该线圈状设备(340)包括一个带有内芯(342)的线圈和一个外层或套筒(344)，套筒(344)带有一个紧固环(346)，固定在环状支撑设备(336)缘(336a)下。图42中，紧固环(346)与右手边接合，处于向左手边接合的过程中。这种接合可以通过使用形状记忆合金来进行，将合适的电流通过紧固设备(346)进行激活，将其充分固定在紧固位置缘(336a)下。
图43显示了另一种心脏瓣膜置换系统，其中置换瓣膜(350)带有一个环状织物材料的套筒(352)。缝线(354)穿过一个前述的线圈状设备(362)的套筒(360)，缝进套筒(352)中。在一点处，套筒(352)以铰链结构(364)固定在套筒(360)上，该结构也可用缝线形成。沿整个瓣环将套筒(352)缝在套筒(360)上，拉紧缝线(354)，就可将置换瓣膜(350)紧固在支撑设备(362)上。在紧固之前，医生应切除现有的二尖瓣瓣膜的瓣叶。
尽管用优选实施方案的方式对本发明进行了某种程度的详细描述，但申请人的目的并不是要把本发明权利要求的保护范围局限于此详细描述中。对于本领域的普通技术人员来说，其他的优点和优点是显而易见的。使用者可以根据其需要单独或同时利用本发明的不同特点和设计。本文叙述了本发明以及目前所知的本发明的实施方法。本发明的保护范围只由权利要求限定。

Claims (59)

1、一种用于心脏瓣膜修补的设备，心脏瓣膜包括瓣膜组织，该瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，该设备包括：
第一支撑环，以及
与第一支撑环相连的第二支撑环，以形成线圈状结构，所述第一支撑环紧靠瓣膜的一侧面，第二支撑环紧靠瓣膜相反的一侧面，从而夹住在它们之间的部分瓣膜组织。
2.如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环分别具有一种由外层包覆的内部芯体，上述的内部芯体由比上述外层更坚硬的材料制成。
3.如权利要求1所述的设备，其特征在于，第一和第二支撑环(42’，110)一般具有三角形横截面。
4.如权利要求1所述的设备，其特征在于，还包括多种在所述第一和第二支撑环间伸展的紧固装置。
5、如权利要求4所述的设备，其特征在于，所述的紧固装置包括尖的突状物。
6、如权利要求4所述的设备，其特征在于，所述的紧固装置包括从所述第一支撑环中伸出突状物和在所述的第二支撑环上与所述突状物连接的接受装置。
7、如权利要求1所述的设备，其特征在于，还包括一种致动设备，其与至少一个支撑环连接，和可以操作该设备将紧固设备穿过瓣环组织致动到一延伸位置上。
8、如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环由一种形状记忆合金制成。
9、如权利要求1所述的设备，其特征在于，还包括在所述的第一和第二支撑环至少之一上的可去除材料，以便在开始接合时减小支撑环和瓣膜组织之间的摩擦力，在支撑设备固定在瓣膜组织上时，可以去掉所述的材料以增加摩擦力。
10、如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环的相对表面是粗糙的，以便易于其与瓣环组织的接合。
11、如权利要求10所述的设备，其特征在于，在所述的每个相对面上有一层垫状材料。
12、如权利要求1所述的设备，其特征在于，每个所述的支撑环由一种织物材料制成。
13、如权利要求1所述的设备，其特征在于，至少一个所述支撑环是波浪形的。
14、如权利要求1所述的设备，其特征在于，所述的支撑环是由平板材料制成的。
15、如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环都是用一线圈状细棒整体制成的，所述的细棒一端作为第一支撑环的前端，另一端作为第二支撑环的尾端。
16、如权利要求15所述的设备，其特征在于，所述的前端和尾端一般弯成相对的方向。
17、如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环具有一种多层结构，包括第一种材料的内层和第二种材料的外层，所述的内层的摩擦系数比外层小，所述内层设置在所述第一和第二支撑环的适合于夹住瓣环组织的相对表面上。
18、如权利要求1所述的设备，其特征在于，还包括一种活动式载体，用于将所述的第一和第二支撑环带到瓣环的相对两面，然后去掉载体将第一和第二支撑环安放到瓣环的相对两面。
19、如权利要求1所述的设备，其特征在于，所述的第一和第二支撑环可以调整直径以进行瓣环大小的调节。
20、一种用于心脏瓣膜修补的设备，心脏瓣膜包括瓣膜组织，该瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，此设备包括：
一瓣膜支撑设备，用于连接在心脏瓣膜的至少一侧面上，和
一线圈状活动式载体，与所述的瓣膜支撑设备连接，可将所述瓣膜支撑设备转到所述心脏瓣膜的至少一侧面上，使其与部分瓣膜组织固定从而支撑心脏瓣膜。
21、一种用于心脏瓣膜修补的设备，心脏瓣膜包括瓣膜组织，该瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，该设备包括：
一带有内腔和开端的导管，
上述内腔中带有一伸长的瓣膜支撑设备，可从上述开端处移动，在所述内腔中所述的瓣膜支撑设备具有非线圈状结构，从所述开端处伸出时恢复其线圈状结构。
22、如权利要求21所述的设备，其特征在于，所述的伸长的瓣膜支撑设备带有一被外层包覆的内芯，所述内芯由比所述外层坚硬的材料制成。
23、如权利要求21所述的设备，其特征在于，所述的伸长的瓣膜支撑设备一般具有三角形横截面。
24、如权利要求21所述的设备，其特征在于，还包括：
所述内腔带有的一致动装置，用于将所述伸长的瓣膜支撑设备从所述开端处伸出。
25、如权利要求24所述的设备，其特征在于，还包括：所述的致动装置包括一夹钳器件，可以夹紧和放松所述伸长的瓣膜支撑设备的一端。
26、如权利要求21所述的设备，其特征在于，所述伸长的瓣膜支撑设备由一种形状记忆合金制成。
27、一种用于心脏瓣膜修补的设备，心脏瓣膜包括瓣膜组织，该瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，此设备包括：
第一支撑环，至少一部分由一种形状记忆合金制成，呈激活状或非激活状，和
第二支撑环，至少一部分由所述的形状记忆合金制成并连接在所述第一支撑环上，所述的第一支撑环用于紧靠在瓣环的一侧面，所述的第二支撑环用于紧靠在所述瓣环的另一侧面，一旦所述的形状记忆合金处于所述的激活形状，在所述第一和所述第二支撑环间的部分瓣环组织就会被夹紧。
28、如权利要求27所述的设备，其特征在于，所述的第一和第二支撑环为环状。
29、如权利要求27所述的设备，其特征在于，还包括：
多个紧固元件，位于所述的第一和第二支撑环的至少之一上，可在形状记忆合金处于激活形状时紧固瓣环组织。
30、如权利要求29所述的设备，其特征在于，所述的第一支撑环包括至少一突状物，所述的第二支撑环包括至少一紧固部分以便与所述突状物接合。
31、一种用于心脏瓣膜修补的设备，心脏瓣膜包括瓣膜组织，该瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，此设备包括：
一载体，和
一线圈状元件，以可移动的方式与所述载体连接，所述的线圈状元件具有用于紧靠瓣膜的一侧面的第一支撑环，以及紧靠瓣环另一侧面的第二支撑环，从而夹住在其之间的部分瓣环组织。
32、如权利要求31所述的设备，其特征在于，还包括：
多个紧固设备，可在所述第一和第二支撑环间伸展。
33、如权利要求32所述的设备，其特征在于，所述的紧固设备包括尖的突状物。
34、一种置换瓣膜设备，用于置换患者的心脏瓣膜，包括：
第一支撑环，和
第二支撑环，其与第一支撑环连接成线圈结构，所述的第一支撑环用于紧靠瓣膜的一侧面，第二支撑环紧靠瓣环的另一侧面，从而夹住在其之间部分瓣环组织，和
置换瓣膜，其与所述的第二支撑环连接，和包括至少一个可在所述第二支撑环内伸展的瓣膜器件，以允许或防止血流通过。
35、如权利要求34所述的设备，其特征在于，所述的置换瓣膜以一种可移去的方式与所述第二支撑环连接。
36、如权利要求35所述的设备，其特征在于，所述的置换瓣膜和所述的第二支撑环包括配对紧固器件，可以用相关的方式连接。
37、如权利要求35所述的设备，其特征在于，所述的置换瓣膜用线缝在所述第二支撑环上。
38、如权利要求34所述的设备，其特征在于，所述的第一和第二支撑环一般在相同的平面上。
39、如权利要求34所述的设备，其特征在于，所述的第一和第二支撑环一般不在相同的平面上。
40、如权利要求34所述的设备，其特征在于，所述置换瓣膜和所述的第二支撑环各带有套筒，在它们之间的缝线将所述置换瓣膜和所述第二支撑环紧固在一起。
41、如权利要求34所述的设备，其特征在于，所述的第二支撑环带有的一套筒，该套筒包含一种可移动的紧固器件，其与所述的置换瓣膜相连接，可将所述的置换瓣膜与所述的第二支撑环接合。
42、如权利要求41所述的设备，其特征在于，所述紧固器件由一种形状记忆合金制成。
43、一种修补心脏瓣膜的方法，心脏瓣膜包括瓣膜组织，瓣膜组织包括一个瓣环和多个瓣叶，可以允许和防止血流的进入，此方法包括：
将一线圈状支撑设备的第一端穿过部分瓣膜组织，
旋转此线圈状支撑设备的第一圈将其放在瓣膜的一侧面上，且
将此线圈状支撑设备的第二圈放在瓣膜相对的另一侧面上。
44、如权利要求43所述的方法，其特征在于，还包括：
紧固第一环和第二环，夹住瓣膜组织。
45、如权利要求44所述的方法，其特征在于，紧固第一和第二环的步骤还包括：
将紧固器件插入第一和第二环并穿过瓣膜组织。
46、如权利要求44所述的方法，其特征在于，紧固第一和第二环的步骤还包括：
使用在所述第一环上的多个尖的突状物，穿过瓣膜组织插入所述第二环。
47、如权利要求43所述的方法，其特征在于，插入和旋转的每一步还包括：
从一导管中伸出此线圈状支撑设备。
48、如权利要求43所述的方法，其特征在于，所述线圈状支撑设备在插入时与一载体连接，旋转和定位步骤，及此方法还包括：
在定位步骤后去掉此载体。
49、如权利要求48所述的方法，其特征在于，还包括：
使用多个紧固器件穿过此线圈状支撑设备和瓣膜组织，并在去掉此载体前与该载体相对。
50、如权利要求43所述的方法，其特征在于，所述的线圈状支撑设备包括一种比外层的摩擦力或摩擦系数低的材料，此方法还包括：
在插入和旋转步骤至少一个步骤进行时，至少在外层的一部分上使用该材料，且：
在旋转步骤之后去掉该材料。
51、如权利要求50所述的方法，其特征在于，还包括：
在定位步骤之后去掉该材料。
52、如权利要求43所述的方法，其特征在于，还包括：
调整第一和第二环的至少之一的直径，从而对瓣环的直径进行调整。
53、如权利要求43所述的方法，其特征在于，还包括：
将一置换瓣膜与第一和第二环的至少之一连接。
54、一种置换患者心脏瓣膜的方法，包括：
将一种线圈状支撑设备的第一端穿过瓣膜组织，
旋转此线圈状支撑设备的至少一个的第一环以将其放在瓣膜组织的一侧面上，将此线圈状支撑设备的至少一个的第二环放在瓣膜组织相对的另一侧面上，且
将一置换瓣膜连接到第一和第二环的至少之一上。
55、如权利要求54所述的方法，其特征在于，瓣膜组织是与人体原有心脏瓣膜相连的瓣环。
56、如权利要求54所述的方法，其特征在于，连接置换瓣膜的步骤还包括将该置换瓣膜的套筒缝在第一和第二环之一的套筒上。
57、如权利要求54所述的方法，其特征在于，连接置换瓣膜的步骤还包括将该置换瓣膜旋转到与第一和第二环之一密闭接合。
58、如权利要求54所述的方法，其特征在于，连接置换瓣膜的步骤还包括将该置换瓣膜的套筒旋转到第一和第二环的之一上。
59、如权利要求54所述的方法，其特征在于，连接置换瓣膜的步骤还包括激活一紧固器件，其由一种形状记忆合金制成。
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JP2004502494A (ja) 2004-01-29
US6419696B1 (en) 2002-07-16
ATE384494T1 (de) 2008-02-15
CN1714766A (zh) 2006-01-04
DE60132584D1 (de) 2008-03-13
CA2414022C (en) 2010-02-23
US20020173841A1 (en) 2002-11-21
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JP4739435B2 (ja) 2011-08-03
CN100496432C (zh) 2009-06-10
CA2414022A1 (en) 2002-01-17
DE60132584T2 (de) 2009-01-29
WO2002003892A1 (en) 2002-01-17
CA2673614A1 (en) 2002-01-17
CN1208032C (zh) 2005-06-29
US6964684B2 (en) 2005-11-15
EP1296618B1 (en) 2008-01-23
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US6730121B2 (en) 2004-05-04
JP4373672B2 (ja) 2009-11-25
CA2673614C (en) 2012-05-01

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