CN1391453A - 二尖瓣瓣环成形术环圈和方法 - Google Patents
二尖瓣瓣环成形术环圈和方法 Download PDFInfo
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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
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- 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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Abstract
一种二尖瓣瓣环成形术环圈(30)和用于移植二尖瓣瓣环成形术环圈(30)以通过重新构建二尖瓣瓣环的形状和轮廓来治疗二尖瓣闭锁不全的方法。该瓣环成形术环圈(30)为柔性的,并易于调节成不同的尺寸和形状。该方法基本上消除了瓣环成形术过程之后的伤疤,从而长时间保持环圈和瓣环(34)的柔性。
Description
技术领域
本发明涉及一种二尖瓣(mitral valve)瓣环成形术环圈(annuloplasty ring)和用于植入二尖瓣瓣环成形术环圈的方法以治疗病人的二尖瓣闭锁不全。二尖瓣闭锁不全,也称为二尖瓣回流,为普通的心脏异常,其中心脏的二尖瓣不能正确关闭。
背景技术
在功能正常的心脏中,当左心室处于舒张状态时,氧合血液从左心房通过开启的二尖瓣进入左心室中。当左心室收缩时,血液被推出左心室,由此关闭二尖瓣以防止血液流回或回流到左心房中。氧合血液从左心室被泵送出心脏并引导到身体的其他部分中。
对于二尖瓣闭锁不全,二尖瓣不完全关闭,而当左心室收缩时,一部分血液漏回到左心房中,结果,心脏由于不仅要泵送常规体积的血液,而且还要泵送回流到左心房内的额外体积的血液而工作更沉重。所增加的工作负担对左心室造成过度的疲劳。而过渡的疲劳会最终消耗心脏,并在该状态长时间保持并足够严重时导致死亡。于是,功能正常的二尖瓣对于心脏的泵送效率来说是至关重要的。
二尖瓣瓣环成形术为治疗二尖瓣闭锁不全的公知方法,尽管也使用其他包括替换二尖瓣、修补二尖瓣叶、以及缩短或替换腱索的方法。二尖瓣瓣环成形术为二尖瓣瓣环的修复,其可以通过重新构建正常二尖瓣瓣环的尺寸和形状来使二尖瓣叶完全关闭。这种瓣环成形术大多数包括使用二尖瓣瓣环成形术环圈,其中,该环移植到二尖瓣瓣环上。
有三种基本类型的用于瓣环成形术方法的二尖瓣瓣环成形术环圈。它们包括刚性环圈、柔性环圈和具有柔性元件和刚性元件二者的组合环圈。
刚性环由于他们不具有柔性而支配二尖瓣的形状和轮廓。天然的二尖瓣瓣环响应心脏的运动而弯曲。然而,由于该刚性环,瓣环不能正常弯曲或与心脏的泵血动作一同自由运动。由于这种刚性,使正常情况下成形二尖瓣的生理因素不能在成形二尖瓣中起主导作用。
刚性环的另一个缺点是他们会在具有过“高”的二尖瓣后叶的病人中诱发称为收缩期前向移动的心脏状况。在心室收缩期间,后叶在前叶正常运动相反的方向上推动前叶,导致左心室外流道阻塞。
总之,刚性瓣环成形术环圈不允许二尖瓣瓣环重新构建为由心脏泵血运动所支配的其正常形状和形式。瓣环的形状和轮廓通过环圈本身的非柔性形状和形式所确定。
与刚性环圈不同,由聚酯纤维织物制成的柔性环圈可允许二尖瓣瓣环随着心脏收缩和舒张而运动及弯曲。然而,仍存在一些缺点。为了使二尖瓣叶有效地闭锁,瓣环的正确形状和轮廓是必需的。柔性环圈的一个缺点为在移植期间其趋向于卷曲。卷曲会不利于二尖瓣瓣环,有时会导致二尖瓣口过小。这会导致二尖瓣狭窄。此外,柔性环圈和组合环圈在瓣环成形术之后都不会长时间保持柔软。由于环圈通过直接连接到瓣环上的缝合线固定到位,不可避免地会发展成伤疤和所形成的瓣环僵硬。这种柔性丧失阻碍心脏正常的弯曲和运动,尤其是左心室的弯曲和运动,因此,心脏功能不能最佳发挥。
发明内容
本发明的瓣环成形术环圈为一种组合环圈,其包括大致为刚性的第一部分和第二柔性部分,环圈可以轻易调整为配合任何特定病人的瓣环。移植本发明的瓣环成形术环圈的方法包括在围绕二尖瓣瓣环的房室沟的脂肪垫内安装环圈。该方法不需要一连串穿过二尖瓣瓣环组织以将环圈固定到位的缝合。从而基本上消除了所导致的伤疤和瓣环僵硬。
当结合本发明的方法时,本发明的环圈定位在靠近二尖瓣瓣环的房室沟的脂肪垫中。环圈的柔性部分靠近瓣环的柔性后部延伸,而环圈的刚性部分跨过瓣环的大致刚性的内三角区。由于环圈的柔性部分固定在瓣环后部的房室沟内,不需要将柔性部分直接缝合到二尖瓣瓣环上。结果,基本上消除了瓣环的伤疤,从而使环圈和瓣环长时间保持柔软。就像在正常心脏中一样,这种柔性使二尖瓣瓣环在心脏收缩和舒张期间能够在多个平面内弯曲,结果为二尖瓣的术后功能良好以及左心室术后功能良好。
本发明的目的是提供一种瓣环成形术环圈,其重新构建二尖瓣瓣环的正常形状和轮廓。
本发明的另一目的是提供一种用于进行瓣环成形术的方法,该方法基本上消除了二尖瓣瓣环组织的伤疤,从而预防了瓣环成形术之后的柔性丧失。本发明的再一目的是提供一种用于移植瓣环成形术环圈的方法,该方法允许环圈长时间保持柔性。
本发明的再一目的是提供一种瓣环成形术环圈,该环圈足够柔软而允许二尖瓣和瓣环通过不同平面弯曲,并且该环圈定位成重新构建正常二尖瓣瓣环的形状和轮廓。
本发明的再一目的是提供一种柔性的瓣环成形术环圈,在移植过程中该环圈不会卷曲。
本发明的再一目的是提供一种瓣环成形术环圈,该环圈可以按照自然二尖瓣瓣环的所有弯曲方式而弯曲。
本发明的再一目的是提供一种瓣环成形术环圈和移植该环圈的方法,其长时间保持环圈和二尖瓣的柔性。
本发明的再一目的是提供一种用于移植瓣环成形术环圈的方法,该方法使二尖瓣瓣环及其附近组织的伤疤最小。
本发明的再一目的是提供一种呈现出正常二尖瓣瓣环形状的瓣环成形术环圈,以允许二尖瓣有效地起作用。
本发明的再一目的是提供一种瓣环成形术环圈和移植该环圈的方法,其导致二尖瓣的前叶和后叶有效地接合。
本发明的再一目的是提供一种瓣环成形术环圈和移植该瓣环成形术环圈的方法,在心室收缩和舒张时该环圈不会阻碍左心室基底的运动,从而允许左心室有效地起作用。
本发明的再一目的是提供一种瓣环成形术环圈和移植瓣环成形术环圈的方法,该环圈使左心室的基底在收缩和舒张时采取全范围的运动,以允许左心室有效地起作用。
本发明的再一目的是提供一种瓣环成形术环圈,该环圈允许左心室随着心脏泵血而自然地运动,并允许二尖瓣瓣环响应左心室的运动自由弯曲。
本发明的再一目的是提供一种瓣环成形术环圈和移植瓣环成形术环圈的方法,其不需要沿着二尖瓣瓣环的后部进行多次缝合而将环圈固定到位。
本发明的再一目的是提供一种瓣环成形术环圈,该环圈可以容易地调节尺寸。
本发明的再一目的是提供一种瓣环成形术环圈,该环圈可以通过调节环圈的圆周而容易地调节形状。
本发明的再一目的是提供一种用于瓣环成形术环圈的成套元件,该环圈重新构建二尖瓣瓣环的正常形状和轮廓。
附图说明
图1A-1F为从心房位置看到的心脏的剖视图,示出了在房室沟内移植二尖瓣瓣环成形术环圈的优选方法;
图2A是本发明的二尖瓣瓣环成形术环圈处于封闭结构的优选实施例的俯视图;
图2B是处于封闭结构的二尖瓣瓣环成形术环圈的侧视图;
图3是带有针的二尖瓣瓣环成形术环圈的分解视图;
图4是心脏一部分的示意性剖面图,示出了其内移植了瓣环成形术环圈的房室沟;
图5是外科构型的二尖瓣瓣环成形术环圈的视图;
图6是开放构型的二尖瓣瓣环成形术环圈的视图。
具体实施方式
左心室是心脏的主要泵血腔室。来自肺的氧合血液进入左心房,并穿过二尖瓣进入左心室。血液从左心室泵送到身体其余部分。
如图1A-1F所示,二尖瓣30为包括一对小叶的单向被动阀,包括较大的前叶32和较小的后叶33。小叶相应在二尖瓣30每一侧的心脏5内的压差而开启和关闭。每个前叶32和后叶33的基底连接到二尖瓣瓣环34上。
二尖瓣瓣环34的轮廓指在瓣环34总平面上看的瓣环34的外形或形式。瓣环34的形状为从二尖瓣30的心房侧、向下看二尖瓣瓣环34所看到的形状。
二尖瓣瓣环34包括后部35和前部36,前部36(也称为内三角区段或部分)大致为平直的,并大致为刚性的部分。瓣环34的后部35为柔性的曲线性部分,其比前部36围绕瓣环圆周更大的部分。右纤维三角区37和左纤维三角区38标示大致平直部分的端部,并在后部35和前部36之间限定相交点。
参照图2A和2B,示出构成本发明的瓣环成形术环圈10的优选实施例。该环圈10包括第一部分11和第二部分15,第一部分11具有第一端12和第二端13,而第二部分15包括近端16和远端17。用于确定瓣环成形术环圈10尺寸的装置包括从第二部分的远端17的最外边缘向内延伸的测量标记18。瓣环成形术环圈10还包括可分离的针20,如图3所示,该针20具有尖端72和连接端73。
瓣环成形术环圈10包括用于连接第一部分的第二端和第二部分的远端的第一装置和用于连接第一部分的第一端和第二部分的近端的第二装置。环圈10还包括用于将第二部分的第二端连接到针上的第三装置。
在一个优选实施例中,用于将第一部分的第二端连接到第二部分的远端的第一装置、用于将第一部分的第一端连接到第二部分的近端的第二装置、以及用于将第二部分的第二端连接到针上的第三装置包括摩擦接合部分。
摩擦接合部包括在第二部分15中的中空内部19,该中空内部19在近端16和远端17处具有外部开口71。中空内部19可以延伸第二部分15的整个长度,或另外地,可以限制于第二部分15的端部16、17。中空内部19内径基本等于第一部分11的第一端12和第二端13的外径,并也基本上等于针20的连接端73的外径。
第二部分15近端16的中空内部19的外部开口71其内接收第一端12,而中空内部19在远端17上的外部开口71接收第一部分的第二端13,或针20的连接端73,当第一部分11的端部12、13通过外部开口71插入到中空内部19中时,在相应的内、外直径之间形成摩擦接合,该接合使各部分11、15的端部固定到一起。同样,当针20的连接端73通过外部开口71插入到远端17的中空内部19中时,针20通过摩擦接合固定在中空内部19中。
虽然用于将第一部分的第二端连接到第二部分的远端的第一装置、用于将第一部分的第一端连接到第二部分的近端的第二装置、以及用于将第二部分的第二端连接到针上的第三装置包括摩擦接合部,但可以使用任何适宜的分离型装置替代。
第一部分11和第二部分15为细长的,在一个优选实施例中,第一部分11在中间部分具有弓形或弯曲70,弓形70从第一端12和第二端13所处的基准面偏离大约1.0mm。在另一优选实施例中,环圈的第一部分是直的而不带有弓形。
第一部分11由大致刚性的材料形成。优选地是,该材料能够长时间保持其刚性,同样优选地是,该材料相对身体组织为惰性或与身体组织相适应。可以用作第一部分的这种材料的示例为钛、不锈钢、热解碳和各种塑料。同样,也可以使用其它适宜选择的材料。
构成第二部分15的材料为柔性的并且能够固定到第一部分上。优选地,该材料相对身体组织为惰性或与身体组织相适应。可以用作第二部分的这种材料的示例为硅橡胶、聚乙烯、涤纶和特氟隆。同样,也可以使用其它适宜选择的材料。
本发明的瓣环成形术环圈10重新构建二尖瓣瓣环34的正常形状和轮廓。瓣环成形术环圈10的第一部分11在移植后靠近内三角区36,如图1A-1F所示。弓形70的曲率定位成符合二尖瓣瓣环34位于主动脉瓣根部的部分。第一部分11和内三角区36都基本上是刚性的。由于内三角区36一般不响应心脏的运动而弯曲,因此,第一部分11不需要折弯或弯曲。
第二部分15移植在瓣环后部35附近。后部35和第二部分15都是柔性的,因此可以随着由于左心室舒张和收缩导致的心脏的自然运动而弯曲和移动。此外,如图4所示,将瓣环成形术环圈移植到房室沟39的脂肪垫40中的方法确保了瓣环和环圈10的第二部分15长时间保持柔软。
再次参照图1A-1F,针20作用为将环圈10移植到正确位置并定位在围绕二尖瓣瓣环34的房室沟39内的引导部分。针的尖端72优选地为倒圆的尖端,其足够锋利以刺穿组织以用于移植,但又足够钝以在房室沟内运动而不会损伤关键区域。
可以调节瓣环成形术环圈10的尺寸和形状。利用第二部分15上的测量标记18作为导引,可以确定该部分适宜的长度,然后,第二部分15上不需要的长度可以通过切割去除,如图1D所示。通过改变第二部分15的长度,瓣环成形术环圈的圆周也可以加以改变。
如图2A所示,用于将第一部分的第一端连接到第二部分的近端的第二装置和用于将第一部分的第二端连接到第二部分的远端的第一装置将第一部分11的各端12、13固定到第二部分15的相应端16、17上,以形成封闭的环形。在一个优选实施例中,其中用于连接的第一和第二装置包括摩擦接合部,第二部分的近端16和远端17优选地彼此靠近地设置在第一部分11的中央区域,从而覆盖第一部分11的相当大的部分。另外,第一部分11的第二端13可以为自由的并且未被连接,而第二部分15的远端17连接到针20上,以用于进行瓣环成形术,如图5所示。
第一部分11的长度短于第二部分15的长度。第一部分11的长度可以改变,但优选地是,其长度不超过被修复的二尖瓣瓣环内三角区36的长度的50-75%。对于特定的瓣环成形术环圈的必不可少的比例将取决于第二部分15的柔性。例如,形成第二部分15的材料越柔软,第一部分11相对于内三角区36的长度应该越长。相反,第二部分15的材料的柔性越小,第一部分11相对于内三角部分36的长度应该越短。
两个部分的长度可以相对于彼此加以变化,以便获得瓣环成形术环圈10的封闭环形的各种形状。例如,通过相对于第二部分15的长度加长第一部分11,瓣环成形术环圈将变成以前部到后部距离较小为特征的扁平形。
在本发明一个优选实施例中,第一部分11具有大约1.5cm的长度,而总体直径大约为6mm。然而,直径可以变化,只要其适应要修复的二尖瓣瓣环并且其可以预防环圈非故意的变形或破裂即可。
在一个优选实施例中,标记18以间隔大约为1.0mm分隔开标注。然而,各间隔可以分隔开沿第二部分15延伸所需长度的任意适宜的距离。
图6中示出瓣环成形术环圈10的开放构型,其中,第一部分11具有连接到第二部分的近端16上的第一端12。第一部分11的第二端13和第二部分15的远端17未连接。
如图2A所示,封闭结构包括连接到第二部分15的近端16上的第一部分11的第一端12和连接到第二部分15的远端17上的第一部分11的第二端13。在封闭构形中,瓣环形成封闭环。在瓣环成形术过程之后,环圈10处于其封闭构形。
在图5中,本发明的瓣环成形术环圈10以外科构型示出,其中,第一部分11的第一端12连接到第二部分15的近端16上,而针20连接到第二部分15的远端17上,第一部分11的第二端13未连接。外科构型主要被指定为在瓣环成形术过程中使用。
在如图1E所示瓣环成形术环圈10被移植后,第一部分11与二尖瓣瓣环34的内三角区36对齐,从而,弓形70符合靠近主动脉瓣根部的瓣环34的形状。在左纤维三角区38和右纤维三角区37之间延伸的内三角区36基本上为刚性的,与环圈的第一部分11一样。第二部分15主要围绕瓣环34的后部35移植,并处于房室沟39的脂肪垫40中,如图4所示。第二部分15被允许随着心脏的运动而与瓣环34的后部35一起自由移动和弯曲。
参照图1A-1E,瓣环成形术环圈10安装在二尖瓣瓣环34附近,并处于房室沟39的脂肪垫40内。在环圈10移植后,第二部分15被切割到对病人适合的尺寸。第二部分15的远端17然后连接到第一部分11上。优选地是,环圈10在左和右纤维三角区被缝合到瓣环上。然而,如果认为不需要的话,可以免除这种缝合。
为了将瓣环成形术环圈移植到病人体内,针20连接到第二部分15的远端17上,而第一部分11的第一端12连接到第二部分15的近端16上,如图5中的外科构型所示。在一个优选实施例中,针通过将其接合端73插入到第二部分15的中空内部19的外部开口71中。
针20的尖端在右纤维三角区37处从心内部分穿过心内膜65和左心房心肌壁46,如图1A所示,同时,牵引着其后面的环圈10第一部分11和第二部分15,从而,如图1B所示,第二部分15中的一部分最终穿过左心房心肌壁46。针20在向后方向上恰好在二尖瓣瓣环34外部并平行于瓣环34穿行。针20的尖端围绕二尖瓣瓣环34的外曲率并在房室沟39的脂肪垫40之内穿行。针20在顺时针方向向左纤维三角区38运动。
在左纤维三角区38,针的尖端72通过左心房心肌壁46从心外膜60穿回,并通过在左纤维三角区38处的心内膜65穿回,从而沿着前部36将第一部分11牵引到位,并将第二部分15牵引到房室沟39之内的位置,从而第二部分15与二尖瓣瓣环34的后部35相邻,如图1C所示。
参照图1D,瓣环成形术环圈10利用测量标记18确定尺寸,以确定第二部分15的适宜长度以及并由此确定瓣环成形术环圈10的适宜圆周。若需要的话,远端17可以通过在第二部分15的选定为之处切断第二部分15而切割成所需尺寸。针10可以在定尺寸和/或切割第二部分15之前取下,或者,在定尺寸和/或切割过程中,针也可以保持连接到环圈10上。
然后第二部分15的远端17连接到第一部分11的第二端13上,在图1E所示的一个优选实施例中,第二端13和远端17通过摩擦接合而连接,其中第一部分11的第二端13插入到第二部分的中空内部19中,直到第二部分15的远端17和近端16彼此靠近第一部分11的大致中间点为止。
在用于移植瓣环成形术环圈的方法的另一实施例中,该步骤方向相反,其中,针20的尖端72首先从左纤维三角区38处的心内部分穿过心内膜65和左心房心肌壁46,然后在大致平行于瓣环34的向后方向上穿行。针20逆时针方向围绕瓣环34移动到右纤维三角区37。在右纤维三角区37处,针的尖端72通过左心房心肌壁46从心外膜60穿回,并通过心内膜65穿回。然后,如上述步骤以相反的逆时针方向进行,而持续该步骤。
在瓣环成形术环圈10就位后,添加图1F所示的缝合线80、81以将瓣环成形术环圈10固定到瓣环上。优选地是,在左纤维三角区和右纤维三角区处,可以使用多个缝合线80以将环圈10固定到内三角区36上。由于内三角区36在自然二尖瓣瓣环中基本上是刚性的,由于这些缝合线80导致的伤疤基本不会与瓣环剩余部分的正常弯曲以及左心室的运动向干涉。
另外,至少一个缝合线81可以被用于将第二部分15固定于房室沟39内,以作为防止环圈10在移植后有可能滑动的附加的防护措施。这个缝合线81优选地位于第二部分15的中点附近。
本发明优选实施例允许二尖瓣瓣环保持其正常的弯曲,该弯曲又使左心室能够以正常方式随着其收缩和舒张而运动。此外,移植方法允许瓣环成形术环圈以及瓣环在瓣环成形术之后长时间保持柔性,这是由于不需要用穿过后部二尖瓣瓣环组织的缝合线将环圈固定到位。
该环圈还重新构建了允许二尖瓣的前叶和后叶有效接合的二尖瓣瓣环的正常形状和轮廓。另外,环圈的尺寸和形状可以加以调节,以使其容易地适应不同的病人。
在一个示例中,本发明的瓣环成形术环圈可以利用柔性材料制成,该材料也具有弹性以包含第二部分。环圈的弹性适应二尖瓣瓣环在左心室舒张期间的扩张,并适应左心室收缩期间瓣环的收缩。换句话说,除了弯曲以外瓣环可以与左心室的收缩和扩张一同收缩和扩张。
在另一示例中,第一部分11和第二部分15在相应的第一端12和近端16一体地连接,其中,第一部分保持充分的刚性,而第二部分15保持柔性。两个部分的一体接合可以通过共挤、模制或其他所选择的适宜制造技术予以实现。
虽然参照本发明特定的优选实施例对本发明进行了相当详细地描述,但是其他实施例也是有可能的。因此,所附权利要求书的精髓和范围不应被限制于在此包含的优选实施例的描述中。
Claims (30)
1.一种用于修复病人心脏内的二尖瓣的瓣环成形术环圈,所述瓣环成形术环圈包括:
(a)用于移植到二尖瓣附近的第一部分;以及
(b)用于移植到心脏内房室沟的脂肪垫之中的第二柔性部分。
2.如权利要求1所述的瓣环成形术环圈,其特征在于,所述第二柔性部分包括近端和远段以及用于将远端连接到针上的装置。
3.如权利要求2所述的瓣环成形术环圈,还包括具有连接端的针,该连接端具有一外径。
4.如权利要求3所述的瓣环成形术环圈,其特征在于,所述用于将远端连接到针上的装置包括摩擦接合部。
5.如权利要求4所述的瓣环成形术环圈,其特征在于,所述第一部分还包括第一和第二端,所述第一和第二端具有一外径;
所述瓣环成形术环圈还包括:
(a)用于将第二柔性部分的远端连接到第一部分的第二端上的第一装置;
(b)用于将第二柔性部分的近端连接到第一部分的第一端上的第二装置。
6.如权利要求5所述的瓣环成形术环圈,其特征在于,所述用于连接的第一装置包括摩擦接合部,而所述用于连接的第二装置包括摩擦接合部。
7.如权利要求6所述的瓣环成形术环圈,其特征在于,所述第一和第二端的所述外径大致等于所述中空内部的所述内径,而所述用于连接的所述第一装置的所述摩擦接合部处于所述远端处的所述中空内部的所述内径和所述第二端的所述外径之间,用于连接的所述第二装置的所述摩擦接合部在所述近端处的所述中空内部的所述内径和所述第一端的所述外径之间。
8.如权利要求5所述的瓣环成形术环圈,还包括:
(a)开放构型,其中,所述第一部分通过所述用于连接的第二装置连接到所述第二部分上,而所述第一部分的所述第二端和所述第二柔性部分的所述远端不连接;
(b)封闭构型,其中,所述第一部分通过用于连接的所述第一装置和第二装置连接到所述第二部分上,从而形成环形;以及
(c)外科构型,其中,所述第一部分通过用于连接的所述第一装置连接到所述第二部分上,而所述第二柔性部分通过用于将所述第二柔性部分的所述远端连接到所述针上的所述装置连接到针上。
9.如权利要求4所述的瓣环成形术环圈,其特征在于,柔性部分的远端还包括中空内部,该部分具有大致等于针的连接端的外径的内径,而所述摩擦接合部在所述内径和所述连接端的外径之间。
10.如权利要求1所述的瓣环成形术环圈,其特征在于,所述第一部分为刚性的,且第一和第二端大致为直的,所述第一部分还具有第一端和第二端之间的弓形。
11.如权利要求1所述的瓣环成形术环圈,还包括用于确定环圈尺寸的装置。
12.一种将瓣环成形术环圈移植到病人心脏内的方法,包括:
将瓣环成形术环圈的柔性部分移植到心脏的房室沟的脂肪垫中;
将瓣环成形术环圈的刚性部分定位在二尖瓣瓣环的附近;以及
将瓣环成形术环圈形成为环形。
13.如权利要求12所述的方法,其特征在于,瓣环成形术环圈包括连接到柔性部分上的针。
14.如权利要求13所述的方法,其特征在于,将瓣环成形术环圈的主要部分移植到房室沟的脂肪垫中的步骤还包括:
通过心内膜和左心房心肌壁从右纤维三角区处的心内方面插入针的尖端;
在右纤维三角区处将针和一部分瓣环成形术环圈从心内方面穿过心内膜和左心房心肌壁;
使针和一部分瓣环成形术环圈在向后方向上,在二尖瓣瓣环外部并平行于二尖瓣瓣环穿行;以及
从心外膜方面将针的尖端插入而通过左心房心肌壁,并通过右纤维三角区处的心内膜返回;
将针和一部分使针和一部分瓣环成形术环圈从心外膜方面通过左心房心肌壁穿回,并通过左纤维三角区处的心内膜返回。
15.如权利要求14所述的方法,其特征在于,定位刚性部分还包括:
通过拉动针而以大致平行于二尖瓣瓣环的后部的方向定位柔性部分;
将瓣环成形术环圈的刚性部分沿着二尖瓣瓣环的前部对齐;以及
定位刚性部分的弓形,以符合靠近主动脉瓣根部的二尖瓣瓣环的轮廓。
16.如权利要求13所述的方法,还包括:
在将环圈移植并定位之后并在将环圈形成为封闭环形之前,确定瓣环成形术环圈的适宜尺寸;以及
将瓣环成形术环圈切割成适宜的尺寸。
17.如权利要求16所述的方法,还包括:
在将环圈移植并定位之后并在确定适宜尺寸之前,将针与瓣环成形术环圈分离。
18.如权利要求16所述的方法,其特征在于,将瓣环成形术环圈形成为封闭环形的步骤还包括:
通过将刚性部分的第二端插入到柔性部分远端的中空内部而将刚性部分的第二端与柔性部分的远端连接。
19.如权利要求12所述的方法,还包括:
在左和右纤维三角区处将瓣环成形术环圈缝合到二尖瓣瓣环上。
20.如权利要求19所述的方法,还包括:
将瓣环成形术环圈缝合在房室沟的脂肪垫中。
21.一种用于瓣环成形术环圈的成套元件,包括:
(a)第一部分;
(b)第二柔性部分,具有一近端和一远端;
(c)用于将第二柔性部分的远端连接到针上的装置。
22.如权利要求21所述的用于瓣环成形术环圈的成套元件,还包括具有连接端的针,该连接端具有一外径。
23.如权利要求22所述的用于瓣环成形术环圈的成套元件,其特征在于,所述用于将远端连接到针上的装置包括摩擦接合部。
24.如权利要求23所述的用于瓣环成形术环圈的成套元件,其特征在于:
所述第一部分还包括第一端和第二端,所述第一和第二端具有一外径,并且
所述瓣环成形术环圈还包括:(a)用于将第二柔性部分的远端连接到第一部分的第二端上的第一装置,以及(b)用于将第二柔性部分的近端连接到第一部分的第一端上的第二装置。
25.如权利要求24所述的用于瓣环成形术环圈的成套元件,其特征在于,用于连接的所述第一装置包括摩擦接合部,且用于连接的所述第二装置包括摩擦接合部,所述第二柔性部分在远端和近端处包括中空内部,所述中空内部具有大致等于第一部分的第一和第二端的外径的内径,
其中,用于连接的所述第一装置的所述摩擦接合部在所述远端处的所述中空内部的所述内径和所述第二端的所述外径之间,而用于连接的所述第二装置的所述摩擦接合部在所述近端处的所述中空内部的所述内径和所述第一端的所述外径之间。
26.如权利要求23所述的用于瓣环成形术环圈的成套元件,其特征在于,第二柔性部分的远端还包括中空内部,其具有大致等于针的连接端的外径的内径,而用于将远端连接到针上的所述装置的摩擦接合部在所述内径和连接端的所述外径之间。
27.如权利要求21所述的用于瓣环成形术环圈的成套元件,其特征在于,所述第二柔性部分还包括用于确定环圈尺寸的装置。
28.一种用于瓣环成形术外科中的瓣环成形术环圈,瓣环成形术用于通过将二尖瓣瓣环恢复到由左心室,二尖瓣和二尖瓣瓣环的运动所确定的正常形状和柔性而校正病人的二尖瓣闭锁不全,其中,所述瓣环成形术环圈包括:
具有第一端、第二端和一段长度的第一刚性部分,所述第一和第二端具有一外径;
具有远端、近端、一段长度、用于确定环圈尺寸的装置、以及至少一个中空内部的第二柔性部分,该中空内部在近端和远端处具有外部开口,该开口具有一内径;
倒圆尖端的针,该针具有尖端和连接端,而连接端具有一外径;
用于将第二部分的远端连接到第一部分的第二端的第一装置;
用于将第二部分的近端连接到第一部分的第一端的第二装置;
用于将第二部分的远端连接到针上的第三装置;
其中,所述第一部分的外径和连接端的外径基本等于中空内部的内径,而所述第二柔性部分的所述长度大于所述第一刚性部分的所述长度;
用于连接的所述第一装置包括远端处的中空内部的内径和第二端的外径之间的摩擦接合部;用于连接的所述第二装置包括近端处的中空内部的内径和第一端的外径之间的摩擦接合部;而用于连接的第三装置包括远端处的中空内部的内径和针的连接端的外径之间的摩擦接合部;
所述用于确定环圈的尺寸的装置还包括在第二部分的远端上的测量标记;
所述第一刚性部分大致为直的,且还包括定位于第一和第二端之间的弓形;
瓣环成形术环圈还包括:
(1)由通过用于连接的所述第二装置连接到所述第二部分上的所述第一部分限定的开放构型,其中,在第二部分近端的中空内部和外部开口其中接收第一部分的第一端,第一端和近端由所述摩擦接合部固定到一起,而所述第二端和所述远端未连接;
(2)由通过用于连接的所述第二和第三装置连接到所述第二部分和所述针上的所述第一部分限定的外科构型,其中,在第二部分近端处的所述中空内部和外部开口其中接受所述第一部分的第一端,第一端和近端由用于连接的所述第二装置的所述摩擦接合部和所述第二部分的所述远端固定到一起,而在第二部分的远端的中空内部和外部开口其内接收针的连接端,远端和连接端通过用于连接的所述第三装置的所述摩擦接合部固定到一起;以及
(3)由通过用于连接的所述第一和第二装置连接到所述第二部分上的所述第一部分限定的封闭构型,其中,在所述第二部分近端处的中空内部和外部开口其中接受所述第一部分的第一端,近端和第一端通过用于连接的所述第二装置的所述摩擦接合部固定,而在第二部分远端处的中空内部和所述外部开口其中接收第一部分的第二端,远端和第二端通过用于连接的所述第一装置的所述摩擦接合部固定;
其中,所述第一刚性部分用于移植到二尖瓣瓣环的前部附近,而所述第二部分用于移植到房室沟的脂肪垫中。
29.一种将瓣环成形术环圈移植到病人心脏中以校正二尖瓣闭锁不全的方法,其中,二尖瓣瓣环被恢复到由左心室、二尖瓣和二尖瓣瓣环运动所确定的正常形状和柔性,包括以下步骤:
(1)提供瓣环成形术环圈,该环圈具有一端连接到刚性部分上的细长柔性部分,该刚性部分具有弓形,并在相对端连接到倒圆尖端的针上;
(2)将针的尖端在右纤维三角区处从心内方面通过心脏的心内膜和左心房心肌壁插入;
(3)在右纤维三角区处,将针和一部分瓣环成形术环圈从心内方面穿过心脏的心内膜和左心房心肌壁;
(4)使针和一部分瓣环成形术环圈在向后方向上,恰好在二尖瓣瓣环外面并平行于二尖瓣瓣环地穿行;
(5)围绕二尖瓣瓣环的外侧在房室沟的脂肪垫中以顺时针方向将针和一部分瓣环成形术环圈穿行到左纤维三角区;
(6)在左纤维三角区,通过左心房心肌壁和心内膜从心外膜方面插回针的尖端;
(7)使针和一部分瓣环成形术环圈通过左心房心肌壁从心外膜方面穿回,并通过左纤维三角区处的心内膜穿回;
(8)将柔性部分大致平行于二尖瓣瓣环的后部定位;
(9)将刚性部分沿着二尖瓣瓣环的前部对齐;
(10)将刚性部分的弓形定位成符合靠近主动脉瓣根部的二尖瓣瓣环的轮廓,并进一步围绕二尖瓣瓣环的后部定位柔性部分;
(11)将针与柔性部分分离;
(12)确定瓣环成形术环圈的适宜尺寸;
(13)将瓣环成形术环圈的柔性部分切割成适宜的尺寸;
(14)通过将柔性部分的远端固定到刚性部分的第二端上而封闭瓣环成形术环圈,而该固定是通过将刚性部分插入到柔性部分的中空内部而实现的;
(15)在左和右纤维三角区将瓣环成形术环圈缝合到二尖瓣瓣环上;
(16)沿着二尖瓣后部将一点缝合到瓣环成形术环圈的柔性部分上。
30.一种瓣环成形术环圈的成套元件,其用于瓣环成形术外科治疗过程中以通过将二尖瓣瓣环回复到由左心室、二尖瓣和二尖瓣瓣环的运动所确定的正常形状和柔性来校正病人的二尖瓣闭锁不全,其中所述瓣环成形术环圈包括:
具有第一端、第二端、一段长度以及外径的第一刚性部分;
具有远端、近端、一段长度、用于确定环圈尺寸的装置、以及至少一个中空内部的第二柔性部分,该中空内部具有在远端和近端处的外部开口以及一内径;
倒圆尖端的针,其具有尖端和连接端,该连接端具有一外径;
用于将第二部分的远端连接到第一部分的第二端上的第一装置;
用于将第二部分的近端连接到第一部分的第一端上的第二装置;
用于将第二部分的远端连接到针上的第三装置;
其中,所述第一部分的外径和连接端的外径大致等于中空内部的内径;
所述用于连接的第一装置包括在两个端部接合时远端处中空内部的内径和第二端的外径之间的摩擦接合部,所述用于连接的第二装置包括在两个端部接合时,近端处的中空内部的内径和第一端的外径之间的摩擦接合部;而用于连接的所述第三装置包括在两个端部连接时远端处的中空内部的内径和针的连接端的外径之间的摩擦接合部。
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CN101087571B (zh) * | 2004-12-15 | 2010-05-12 | 梅德坦提亚国际有限公司 | 改善心脏瓣膜机能的装置和方法 |
CN105007863A (zh) * | 2013-03-12 | 2015-10-28 | 爱德华兹生命科学公司 | 动态瓣环成形术环尺寸设定器 |
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CN105992570A (zh) * | 2014-02-11 | 2016-10-05 | 科法利欧斯有限公司 | 可调节的瓣环成形装置 |
CN105992570B (zh) * | 2014-02-11 | 2018-07-06 | 科法利欧斯有限公司 | 可调节的瓣环成形装置 |
CN110151359A (zh) * | 2014-09-12 | 2019-08-23 | 米特拉尔维尔福科技有限责任公司 | 二尖瓣修复和替换设备及方法 |
CN107789095A (zh) * | 2016-08-29 | 2018-03-13 | 先健科技(深圳)有限公司 | 瓣膜成形环的制备方法 |
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AU778455B2 (en) | 2004-12-09 |
US6565603B2 (en) | 2003-05-20 |
WO2001019292A1 (en) | 2001-03-22 |
EP1237508B1 (en) | 2005-11-16 |
DE60024131D1 (de) | 2005-12-22 |
US6250308B1 (en) | 2001-06-26 |
JP2003509116A (ja) | 2003-03-11 |
US20030229395A1 (en) | 2003-12-11 |
AU7589900A (en) | 2001-04-17 |
EP1237508A4 (en) | 2003-03-26 |
EP1237508A1 (en) | 2002-09-11 |
CA2381898A1 (en) | 2001-03-22 |
ATE309764T1 (de) | 2005-12-15 |
KR20020064878A (ko) | 2002-08-10 |
US20010034551A1 (en) | 2001-10-25 |
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