CN1208032C - 瓣环成形设备 - Google Patents

瓣环成形设备 Download PDF

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CN1208032C
CN1208032C CNB018123716A CN01812371A CN1208032C CN 1208032 C CN1208032 C CN 1208032C CN B018123716 A CNB018123716 A CN B018123716A CN 01812371 A CN01812371 A CN 01812371A CN 1208032 C CN1208032 C CN 1208032C
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equipment
ring
support ring
valve
lobe
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CN1440261A (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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    • 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
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    • 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
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • 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
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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。
附图简要说明
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。
具体实施方式
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42a’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——带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106或小孔，将该支撑设备100的前端100a穿过切口106，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314，一旦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 (35)

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：一种支撑设备(42，42’，42”，52，70，80，90，120，150，162，180，200，212，217，218，219，220，226，240，250，262，260，270，280，300，310，340，362)，所述支撑设备包括第一支撑环，该第一支撑环紧靠瓣膜(18)的一侧面；其特征在于，该支撑设备(42，42’，42”，52，70，80，90，120，150，162，180，200，212，217，218，219，220，226，240，250，262，260，270，280，300，310，340，362)包括与第一支撑环相连的第二支撑环，以形成线圈状结构，第二支撑环紧靠瓣膜相反的另一侧面，从而夹住它和第一支撑环间的部分瓣膜组织。
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由一外层(46，82)包覆的内部芯体(44，44”，110，152，160，228，244，342)，上述的内部芯体(44，44”，110，152，160，228，244，342)由比上述外层(46，82)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，还包括在所述的第一和第二支撑环(80)至少其中之一上有一种可去除材料(84)，以便在开始接合时减小各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(84)以增加摩擦力。
4、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(90)的相对表面是粗糙的，以便易于其与瓣环组织的接合。
5、如权利要求4所述的设备，其特征在于，还包括在所述的每个相对面上有一层垫状材料(94，96)。
6、如权利要求1所述的设备，其特征在于，每个所述的支撑环(80，150，212，226，362)由一种织物材料制成。
7、如权利要求1所述的设备，其特征在于，至少一个所述的支撑环(218，300)是波浪形的。
8、如权利要求1所述的设备，其特征在于，所述的支撑环(217，218)是由一种平板材料制成的。
9、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(228)和第二种材料的外层(230)，所述的内层的摩擦系数比外层小，当第一和第二支撑环夹住瓣环组织时，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(228a)。
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(270)可以调整直径以进行瓣环大小的调节。
11、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(42’，110)一般具有三角形横截面。
12、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(70)由一种形状记忆合金制成。
13、如任一前述权利要求的设备，其特征在于，所述的第一和第二支撑环(42，42’，42”，52，70，80，90，120，150，162，180，200，212，217，218，219，220，226，240，250，262，260，270，280，300，310，340，362)都是用一条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。
14、如权利要求13所述的设备，其特征在于，所述的前端和尾端(220a，220b)一般弯成相对的方向。
15、如前述权利要求1-12之一所述的设备，其特征在于，还包括多个在所述第一和第二支撑环间伸展的紧固装置(44a”，54，70a，70b，92，114，124，164，168，219a，219b，248，252)。
16、如权利要求15所述的设备，其特征在于，所述的紧固装置包括尖的突状物(44a，44a”，114，248)。
17、如权利要求15所述的设备，其特征在于，所述的紧固装置包括至少一个从所述第一支撑环中伸出的突状物(70a，164)和至少一个在所述的第二支撑环上与所述突状物连接的接受装置(70b，168)。
18、如权利要求15所述的设备，其特征在于，还包括一种致动元件(60，112)，其与至少一个支撑环的线圈连接，可以操作该元件将紧固设备(44a，44a”，114，)穿过瓣环组织延伸到位置上。
19、如前述权利要求1-12之一所述的设备，其特征在于，还包括一种活动式载体(40，100，242，290)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。
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：
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。
21、如权利要求20所述的设备，其特征在于，所述的第一和第二支撑环为环状。
22、如权利要求20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。
23、如权利要求22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。
24、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。
25、如权利要求24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。
26、如权利要求25所述的设备，其特征在于，所述的紧固设备包括尖的突状物。
27、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。
28、如权利要求27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。
29、如权利要求28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。
30、如权利要求29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。
31、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一般在相同的平面上。
32、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一般不在相同的平面上。
33、如权利要求27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。
34、如权利要求27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。
35、如权利要求34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。
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