CN103517688A - 用来替代心脏房室瓣的瓣膜假体 - Google Patents

用来替代心脏房室瓣的瓣膜假体 Download PDF

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CN103517688A
CN103517688A CN201180069211.5A CN201180069211A CN103517688A CN 103517688 A CN103517688 A CN 103517688A CN 201180069211 A CN201180069211 A CN 201180069211A CN 103517688 A CN103517688 A CN 103517688A
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valve
valve prosthesis
annular solid
heart
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汉斯·赖纳·菲古拉
亚历山大·劳滕
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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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/2442—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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped

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Abstract

一种用来替代心脏房室瓣的瓣膜假体，其设置有环形体（12），心脏瓣叶（14）固定在该环形体上，并且环形体（12）可插在心脏（20）的瓣膜环（18）中；并且设置有至少一个锚固件（16、16’），它在心室侧从环形体（12）突出来并且可锚固在组织中。

Description

用来替代心脏房室瓣的瓣膜假体
技术领域
本发明涉及一种用来替代心脏房室瓣（即二尖瓣或三尖瓣）的瓣膜假体。
背景技术
当病人的心脏瓣膜功能受损时，为安装瓣膜假体（替代瓣膜），由于病人的整体状况，在心脏上进行开放式的外科手术通常会带来很高的风险，因此越来越多通过导管微创地植入心脏瓣膜假体。
现有技术为此使用支架，替代心脏瓣叶固定在该支架中并且支架为了通过导管导入能够强烈地压缩，并因此能够通过导管在待替换的心脏瓣膜的位置上往前推进并且在该处释放。该例如可球状膨胀或可自膨胀的支架在释放的状态下产生径向的扩张力，该扩张力引起或至少促进了替代瓣膜假体的锚固。对于瓣膜假体的这种锚固来说，替代主动脉瓣膜是尤其合适的，它能够以径向扩张力锚固在功能障碍的主动脉瓣膜的位置上。对此的现有技术请参照例如 EP 1 994 913 A2；EP 1 469 797 B；EP 1 259 195 B1；WO 2007/051620 A1；WO 2007/048529 A1； EP 1 980 220 A1；WO 01/64137 A1；EP 1 255 510 B3以及US 5,411,552。
当然心脏的二尖瓣（即左心房(Atrium)和左心室(Ventrikel)之间的瓣膜）没那么适合于主要通过支架的径向扩张力来力锁合地（通过摩擦）就地锚固的替代假体，因为要避免瓣环的扩张。
发明内容
本发明的目的是，提供一种用来替代房室瓣的瓣膜假体，该瓣膜假体可借助导管植入并且实现稳定且正位的定位和锚固。
按本发明的、用来替代心脏房室瓣的瓣膜假体设置有：
－ 环形体，心脏瓣叶固定在该环形体上，并且适配该环形体，以便插在心脏的瓣膜环中；并且设置有
－ 至少一个锚固件，它朝心室的方向从环形体突出来并且进行适配，以便锚固在腱索、乳头肌或房室瓣的瓣叶中。
按本发明，瓣膜假体借助钩状的锚固件来锚固，这些锚固件固定地与环形体相连，心脏瓣叶(瓣膜叶片)固定在该环形体上/中。这些锚固件平行于环形体的轴线从环形体延伸至心室中，并且这样确定尺寸，即它们能够借助设置在锚固件的心室侧端部上的钩子锚固在该处存在的组织（尤其是腱索、乳头肌或瓣叶）中。即，瓣膜假体的这两个功能（即一方面支撑和固定替代心脏瓣叶，另一方面锚固瓣膜假体）在空间上相互分开：环形体定位在瓣环中并且在该处固定替代心脏瓣叶，而锚固件以上述方式在与环形体隔开的情况下实现瓣膜假体的锚固。
该环形体优选大致构成为扯铃状（diabolof?rmig），因此瓣环能够嵌入环形体的中间部段中，该中间部段与其端部相比具有缩小的直径。在此，环形体在其尺寸和弹性性能方面这样构成，即在插入心脏的瓣膜环中时不会产生明显扩张瓣膜环的径向扩张力。
在收缩时，心室朝心房密封。替代瓣膜假体实现这种密封。作用在假体的心脏瓣叶上的力相当于整个血压。瓣膜假体必须克服此力稳定且持久地正位地锚固。本发明利用的认识是，该力基本上作用在环形体的中间轴线的方向上（相当于在瓣环的中间轴线的方向上），因此所述锚固必须在此方向上吸收相应的拉力。因此，通过按本发明的瓣膜假体，不必通过瓣膜假体和周围组织之间的摩擦锁合来产生主要的锚固力。反而瓣膜假体在收缩期间（此时它处于闭合状态）通过作用在轴向方向上的拉力固定，该拉力通过锚固件导入周围组织（尤其是键索）中并在那里被吸收。
这些锚固件为此例如这样设置有钩状的锚固件元件，即锚固件总体上大致具有角形件的造型，其具有基本上轴向延伸的臂状的元件，该臂状元件在其心房侧的端部上与环形体固定地、尤其不可转动地相连，并且具有设置在臂体的心室侧的端部上的元件，该元件围绕着环形体的轴线弯曲并因此在锚固件旋转时与组织钩在一起，以便尤其相对于心室侧的压力整体上稳定地锚固瓣膜假体。
对于替代二尖瓣来说，本发明建议了两个径直对置的锚固件，而对于三尖瓣来说建议三个锚固件，它们将整圆划分为120°的部段。
环形体优选由金属丝织网成型，尤其由具有形状记忆的材料制成。
按现有技术，这种心脏瓣叶能够固定在环形体上或环形体中，例如按US 5 411 552 或EP 1 255 510 B3。例如从猪上获得二尖瓣或三尖瓣能够缝在环形体中。
本发明提供了心脏瓣膜假体，它的心室侧的锚固可实现稳定且正位的定位。该锚固避免了瓣膜假体在轴向方向上的移位。如果在此谈到轴向或径向方向以及圆周方向，则是基于瓣膜假体的所述环形体，或在移植状态下是指替代的二尖瓣或三尖瓣的瓣环。
按本发明的替代房室瓣是可球状膨胀或可自膨胀的。
替代瓣膜能够借助导管经中隔地、前向经心尖途径地或逆行地经主动脉进行移植。
瓣膜假体借助导管的定位优选这样进行，即所描述的锚固件首先在导管端部上释放出来，然后借助其钩子锚固在组织中，尤其通过整个瓣膜假体连同锚固件围绕着轴线的旋转。然后，瓣膜假体还借助环形体完全释放，使得环形体借助其中心大约到达替代的瓣膜的瓣环上。
在上述实施例的变型方案中，锚固件还可这样构造，即它的钩状锚固件元件不是在圆周方向上延伸，而是具有径向指向外面的钩子，其在瓣膜假体从导管中释放之后径向朝外地扩张，因此可锚固在键索或其它组织中，例如自体的房室瓣的瓣叶（瓣膜叶片）。
按本发明的锚固件这样构成，即在它们之间在心室中留出朝向主动脉和主动脉瓣膜的通道，以保持无阻碍的血液流动。
本发明的另一优选构造方案规定，锚固件的轴向长度例如通过可锁定的伸缩式结构、螺纹连接或类似机构是可调节的，因此外科医生能够就地与解剖学上的情况适应。
如果此处谈到键索，则这也包含位于瓣膜的瓣叶附近的扁平的连接件。
附图说明
下面借助附图详细地阐述了本发明的实施例。其中：
图1  示意性地示出了用来替代心脏房室瓣的瓣膜假体；
图2  示出了按图1的瓣膜假体在心脏中的移植状态；以及
图3  以扩大的比例尺示出了瓣膜假体。
具体实施方式
图1所示的、用来替代心脏房室瓣的瓣膜假体10具有环形体12，未详细示出的心脏瓣叶固定在该环形体中。对于心脏瓣叶14来说，可应用现有技术的这种已知系统，例如由心包膜构成的瓣叶或例如从猪的心脏获得的、缝在环形体12中的心脏瓣膜。该环形体12由金属丝织网构成，并且金属丝的弹性特性和环形体12的尺寸这样选择，即在把瓣膜假体当作二尖瓣或三尖瓣来用时—通常与支架不同—环形体不会产生明显扩张自然的瓣膜环的径向扩张力。
对于环形体12的金属丝织网来说，可应用具有形状记忆的金属，例如镍钛合金。
如图1、2和3所示，环形体围绕着它的轴线A是旋转对称的。环形体12的心房侧的直径D1大于心室侧的直径D2,并且直径D2又大于环形体12的中间直径D3。
如同附图所示的一样，在心室侧锚固件16、16’在轴向方向上从环形体12突出来。如图2所示，这些锚固件16、16’伸进心室22中。环形体12借助其中间部段（即具有缩小的直径D3的部段）定位在二尖瓣的瓣环18中，图2因此示出了，瓣膜假体插在左心房和左心室之间。环形体12的具有扩大直径D1的区域饱满地贴靠在瓣环18的心房侧的部段上，并且当血液从心房24流入心室 22时把瓣膜假体固定在它的敞开状态下。
锚固件16、16’在该实施例中分别具有两个元件，即臂体30a、30b和元件28、28’，所述臂体30a、30b基本上平行于环形体12的轴线A进行延伸，所述元件28、28’钩状地围绕着环形体12的轴线A弯曲地在环形体12的圆周方向上延伸，如图3详细示出的一样。
在所示的实施例中，为不可转动地把锚固件16与环形体12连接起来，一个臂体30具有个臂元件30a、30b，所述臂元件分别基本上平行于环形体的轴线A进行延伸并且在其心室侧的端部上通过环状弯曲部过渡到锚固件的在圆周方向上延伸的元件28、28’中。锚固件16、16’由合适的金属丝成型。
锚固件16尤其根据存在的解剖学上的情况这样确定尺寸，即瓣环18朝锚固件的心室侧的端部的间距在5至40mm的范围内，优选在5至20mm的范围内或在10至25mm的范围内。
与支架-瓣膜假体类似，所述的瓣膜假体可强烈压缩并且可通过导管微创地定位在心脏中，即尤其经中隔地（transepital）、前向经心尖途径地（transapikal）或者也逆行地经主动脉进行定位。为此，可应用这些对专业人员来说已知的导管技术。
用来插入所述瓣膜假体的方法规定，锚固件16、16’第一个在应用点从导管中释放出来。然后在图1至3所示的实施例中，通过环形体12与不可转动地固定在它上面的锚固件16、16’的旋转实现了锚固件16’的锚固，这些锚固件16、16’然后借助其元件28、28’例如锚固在键索中或也在自体的半月瓣中。所述旋转可通过导管自身的旋转实现，或者通过导管中的推动器实现，该推动器可与环形体12旋转作用。当锚固件在组织（例如键索或自体的半月瓣）中钩接和锚固之后，然把瓣膜假体完全从导管中释放出来，其中扯铃状的环形体借助其缩小了直径的中间区域按图2固定在瓣环18中。
在上述实施例的变型方案中，锚固元件28、28’如下变型，即它们不是在圆周方向上延伸，而是径向地朝外延伸，因此它们通过扩张在释放之后可与键索锚固作用，或者根据解剖学上的情况与自体的瓣叶处于锚固作用。

Claims (15)

1.一种用来替代心脏房室瓣的瓣膜假体，具有：
- 环形体（12），心脏瓣叶（14）固定在该环形体上，并且适配该环形体，以便插在心脏（20）的瓣膜环（18）中；并且具有
- 至少一个锚固件（16、16’），它朝心室的方向从环形体（12）突出来并且进行适配，以便锚固在腱索（26）、乳头肌或房室瓣的瓣叶中。
2.根据权利要求1所述的瓣膜假体，其具有一个、两个或三个锚固件（16、16’）。
3.根据权利要求1或2所述的瓣膜假体，其特征在于，环形体（12）在心房侧具有相比于中间的环直径扩大的直径。
4.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，环形体（12）在心室侧具有相比于中间的环直径扩大的直径。
5.根据权利要求3和4所述的瓣膜假体，其特征在于，心房侧的直径大于心室侧的直径。
6.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，适配锚固件（16），以便在瓣膜假体的闭合状态下将基本上轴向的力引到键索（26）中。
7.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，适配环形体（12），以便在插入心脏（20）的瓣膜环（18）中时不会产生明显扩张瓣膜环的径向扩张力。
8.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，所述一个或多个锚固件（16、16’）具有基本上呈钩状的造型。
9.根据权利要求8所述的瓣膜假体，其特征在于，具有基本上钩状造型的锚固件具有臂体（30、30a、30b、30’），所述臂体基本上平行于环形体（12）的轴线（A）进行延伸，并且具有自由地在圆周方向上延伸的锚固件元件（28、28’），使得所述锚固件元件在环形体（12）围绕着其轴线（A）旋转时能够与组织、尤其是键索处于锚固作用。
10.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，为替代二尖瓣设置两个锚固件。
11.根据权利要求1至9中任一项所述的瓣膜假体，其特征在于，为三尖瓣设置三个锚固件。
12.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，环形体（12）由织网成型，尤其由具有形状记忆的材料制成。
13.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，环形体（12）是可球状膨胀的。
14.根据权利要求1至12中任一项所述的瓣膜假体，其特征在于，环形体（12）是可自膨胀的。
15.根据上述权利要求中任一项所述的瓣膜假体，其特征在于，锚固件（16）的长度可在轴向方向上调节。
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