CN111212614A - 用于治疗二尖瓣回流的轴对称可调节装置 - Google Patents
用于治疗二尖瓣回流的轴对称可调节装置 Download PDFInfo
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Abstract
本发明是用于改善二尖瓣功能的假体装置。该装置包括可调节的且轴对称的或细长的密封构件,其被配置用于在二尖瓣小叶之间定位。装置还包括配置以被定位在一个或多个心脏腔室内的可扩张的锚定框架,用于将密封构件以期望的位置和尺寸/形状保持在瓣叶之间。密封构件通过填充可在受损的二尖瓣的相对小叶之间出现的间隙来减少二尖瓣回流,由此恢复适当二尖瓣闭合。
Description
技术领域
本发明涉及心脏瓣膜的修复,且更具体地,涉及用于通过将装置定位在瓣叶之间以改善瓣膜闭合来修复心脏瓣膜的方法和器件。
背景技术
在脊椎动物中,心脏是具有四个泵室的中空肌肉器官:左心房和右心房以及左心室和右心室,每个泵室都提供有其自身的单向流出瓣膜。天然心脏瓣膜被确认为主动脉瓣、二尖瓣(mitral或bicuspid)、三尖瓣和肺动脉瓣。瓣膜将心脏的腔室分开,并且可各自安装在其之间的瓣环中。瓣环包括直接或间接附接到心房和心室肌纤维的致密纤维环。小叶是柔性的(flexible)胶原结构,其附接到瓣环且从瓣环向内延伸以在接合边缘相遇。主动脉瓣、三尖瓣、和肺动脉瓣通常具有三个小叶,而二尖瓣通常具有两个小叶。
如果任何一个心脏瓣膜功能不适当,则心脏的运作(operation)、和由此的患者的健康可受到严重损害。由于许多临床原因,心脏瓣膜可能会出现各种问题。心脏瓣膜狭窄是其中瓣膜无法适当打开的病况。机能不全是瓣膜无法适当闭合的病况。主动脉瓣或二尖瓣的修复或置换最常见,因为它们存在于压力和应力最大的左侧心脏中。在瓣膜置换手术中,将置换假体瓣膜植入到天然瓣环中,这可能涉及天然瓣叶的切除。
在很多患有瓣膜异常的患者中,外科或经皮修复(即,“瓣膜成形术”)是瓣膜置换的理想替代方法。瓣环的重塑(即,“瓣环成形术”)是很多重建性瓣膜成形术程序的核心。瓣环的重塑典型地通过植入假体环(即,“瓣环成形术环”)以稳定瓣环并以纠正(correct)或防止可由瓣环的异常引起的瓣膜的机能不全来完成。瓣环成形术环典型地由覆盖有纤维缝纫环的弹性芯(resilient core)构成。进行瓣环成形术程序不仅修复受损的或患病的瓣环,而且可与其它程序(如小叶修复)联合进行。
由于瓣膜周围的瓣环或松弛的、脱垂的小叶的扩张,心脏瓣膜可失去其适当闭合的能力。小叶也可能由于疾病(如风湿性疾病)已经收缩(shrunk),从而在小叶之间的瓣膜中留下间隙。心脏瓣膜不能闭合将引起血液(与血液的正常流动相反)向后渗漏,通常称为回流。这种回流的常见实例包括二尖瓣回流(即,血液通过二尖瓣渗漏并回到左心房中)和主动脉瓣回流(即,通过主动脉瓣渗漏回到左心室中)。回流可严重损害心脏的功能,因为更多的血液将不得不泵送通过回流瓣膜以保持充分的循环。
心脏瓣膜回流降低心脏的效率、减少血液循环、并且增加对心脏的应力。在早期阶段,心脏瓣膜回流使人疲劳和气短(short of breath)。如果任其发展,该问题可导致充血性心力衰竭、心律失常,或死亡。
二尖瓣回流可由二尖瓣结构的异常引起,如可由对二尖瓣小叶的直接损伤引起。这种回流可由二尖瓣瓣环的形状的变化、后小叶和/或前小叶的损坏、和/或腱索的损坏引起。在这种回流中,前小叶和后小叶不再适当地接合在一起以密封瓣膜,使得在收缩期期间,在前小叶和后小叶的边缘之间保留一个开口,而不是前小叶和后小叶接合以完全闭合二尖瓣瓣环。
二尖瓣修复的各种方法在本领域中是已知的。典型地在二尖瓣的后面(posterioraspect)周围植入瓣环成形术环,已在许多情况下被证明是成功的。这种瓣环成形术环重构(reshape)周围的瓣环,这可导致天然小叶的适当接合。对于二尖瓣的另一种修复技术被称为“领结(bow-tie)”修复,该技术涉及将前小叶和后小叶缝合到一起以对边(edge-to-edge)方式朝向小叶的中部,使血液流动通过由此形成的两侧开口。该过程最初由Dr.OttavioAlfieri开发,并且涉及将患者置于体外旁路上,以进入和缝合二尖瓣小叶。领结技术的后续改进涉及使用经皮路径的心脏不停跳(beating-heart)修复,如使用装设缝线的导管或夹子来将相对的小叶固定在一起。
修复具有不接合小叶的天然瓣膜(包括二尖瓣和主动脉瓣)的另一种路径涉及在小叶之间插入装置,其中该装置尺寸和位置被设置以阻塞以其它方式不接合的小叶之间的间隙。这种修复装置和技术的实例公开在Hauser等人的美国专利号8968395和Maurer等人的美国专利公开号2009/0043382中。这些专利公开了包括部署在下心室中的锚定件的装置,所述锚定件将阻塞装置固定在二尖瓣瓣环内。
当前存在对用于进行心脏瓣膜修复改进的手段的需要。本发明满足了该需要。
发明内容
本发明提供用于改善瓣膜功能的多种装置和方法。本文的装置和方法在不干扰正常瓣膜功能(即,不妨碍小叶、腱索(chordae tendinae)、或乳头肌的自然运动)的情况下减少或消除瓣膜回流。
应该理解的是,即使密封元件与锚定元件的具体组合可能没有明确显示在本文的附图中,本文公开的每个密封元件也可与本文公开的任意和所有锚定元件一起使用。换句话说,基于具体装置的说明,本领域技术人员组合两个这种装置的某些特征应不具有麻烦。因此,应该理解的是,很多密封元件和锚定元件是可互换的,并且本发明涵盖其所有变换。此外,本文公开的每个密封元件可单独使用或与其它锚定件装置组合使用,并且本文公开的每个锚定元件可单独使用或与其它植入装置(如公开于2018年8月24日提交的并且题为“Transcatheter Device for Treating Mitral Regurgitation”的美国专利申请号16/112,388中的锚定件和密封元件)组合使用。
本发明的装置可被利用于标准开放式手术程序(open surgical procedures)、微创程序、或经皮程序。在一个实施方式中,装置可通过开胸(例如,经心尖地或经心房地)递送。在另一实施方式中,装置可通过左心房顶上方进行的切口引入。在又另一实施方式中,装置可经由胸腔镜通过右胸递送到左心室中,这可经心尖地进行。装置也可被经皮地(如经由一个或多个导管)递送到患者的动脉系统中(例如,通过股或肱动脉)。
该装置的优点包括低递送轮廓,这有益于微创和经皮递送方法。该装置被配置以适当地与天然小叶、心室、心房、和瓣下器件相互作用。装置保留而不是阻碍天然小叶的运动性和动态运动(除非对适当接合是必要的)。天然小叶和腱索得以保留,并继续运作(包括对抗收缩闭合压力)。因此保留了瓣下过程和左心室协调性。装置可被配置使得其不使天然二尖瓣小叶或瓣环向外扩张,使得不必担心左心室流出道(LVOT)受到冲击/阻碍。密封元件的形状和低轮廓最小化舒张期期间的流阻,并且不存在由装置产生的停滞区。单个装置可适用于大范围的瓣膜尺寸。
装置可适用于众多的二尖瓣回流病况,包括由具有不同量的瓣环扩张的小叶脱垂(I型)、局灶性小叶脱垂(II型)、和小叶栓系(tethering)(IIIb型)引起的那些病况。
本公开的实施方式提供用于改善缺陷性心脏瓣膜(如二尖瓣)的功能的装置和方法。期望利用经皮或微创手术方法将本文公开的装置和方法递送到对象的心脏中。因此,本文描述的期望的递送方法可不需要体外循环(例如,来自对象的循环的血液按路线递送体外以对其进行处理,然后返回对象的循环)。例如,在一种实施方式中,将递送导管(或类似的递送装置)插入通过胸壁中的切口,然后通过心脏组织(例如,通过心尖),进入患者的不停跳心脏的腔室中。递送导管可允许假体装置被以皱缩(collapsed)构型递送到心脏中,然后在心脏内扩张用于治疗缺陷性心脏瓣膜。因为递送方法可不需要体外循环,与传统心脏直视手术相比可大大减少并发症。
用于治疗二尖瓣的本发明的实施方式是这样的装置,该装置包括可扩张的假体密封构件,该假体密封构件在扩张时具有轴对称的顶部轮廓(或细长的或椭圆的顶部轮廓),该密封构件在扩张时成形以接触二尖瓣的小叶。装置还包括耦接到密封构件并配置以将密封构件固定在二尖瓣小叶之间的期望的位置处的锚定构件。锚定构件可具有轴对称的顶部轮廓。密封构件和锚定构件可以是径向可皱缩的和径向可扩张的,这可允许装置经由导管被递送和部署。
各种锚定元件在本发明的范围内。很多锚定元件可以是轴对称的,即是围绕从下(例如,心室)端行进至上(例如,心房)端的轴线对称的。在一种实施方式中,锚定元件可具有在不干扰二尖瓣小叶的运动的情况下配置以围绕二尖瓣瓣环延伸并接触邻近二尖瓣瓣环的心房组织的上部、配置以围绕天然瓣叶延伸并接合邻近二尖瓣瓣环的心室组织的下部、和配置以支撑密封构件的中部。锚定元件上部可具有上部,该上部可具有多个径向延伸臂以接合心脏组织(如邻近二尖瓣的心房组织)。下部可具有多个径向延伸臂以接合心脏组织(如邻近二尖瓣的心室组织),并且其尺寸可设置使得当部署下部时,天然瓣叶可随着心跳打开和闭合,而来自下部的干扰有限或没有干扰。在装置的一种实施方式中,除了密封元件外,天然瓣叶的打开和闭合不受装置的任意和所有部分的限制,该密封元件在收缩期期间接合天然瓣叶以在天然小叶之间形成密封,从而防止二尖瓣回流。
根据本发明的锚定构件可被配置,使得锚定构件不扩张天然二尖瓣瓣环,因为这种瓣环扩张可能以其它方式引起瓣膜效率降低。例如,锚定构件可被配置,使其不使天然二尖瓣瓣环受到径向-膨胀力。锚定构件可被配置,使得下锚定部向上压靠天然瓣环,而上锚定部向下压靠天然瓣环,使得天然瓣环的组织保持在下锚定部和上锚定部之间,但瓣环不受来自锚定构件的径向-膨胀力。这种实施方式通过将瓣环固定在相对的锚定部之间甚至可防止进一步瓣环扩张。
根据本发明的锚定构件可以是可自扩张的,如经由记忆材料(如镍钛诺)的构造。锚定构件可替代地由其它材料(如不锈钢或钴铬)形成。
根据本发明的另一种锚定元件被配置用于部署在单个心脏腔室(如心房),其中仅密封元件延伸出腔室并进入心脏瓣膜和瓣环中。例如,锚定元件可具有配置以接合心脏腔室的上部的多个上臂、和配置以接合相同心脏腔室的下部的多个下臂。上或下臂、或锚定元件的其它结构,可具有弯曲部(curves),该弯曲部被配置以充当缓冲器以允许锚定元件响应于心脏腔室随着心跳的运动而挠曲。
根据本发明的密封元件被配置以以径向皱缩的但拉长的构型引入,然后被缩短并径向扩张至期望的形状以改善瓣膜功能。密封元件的顶部轮廓可以是轴对称的或细长的(例如,椭圆的),并且其尺寸可被设置为部署在天然瓣叶之间的位置处的心脏的天然瓣膜(例如,二尖瓣)的瓣环中,以在心室的收缩期期间接触天然瓣叶以产生密封,从而防止血液从心室回流到心房,同时允许天然瓣叶随着心跳打开和闭合。密封元件可具有上端、下端、前表面、和后表面。前表面可被配置以与二尖瓣前小叶接合,并且后表面可被配置以与二尖瓣后小叶接合。密封元件可具有网状支撑框架,该网状支撑框架具有递送构型和扩张构型,在所述递送构型中,网状支撑框架大体上呈具有递送直径的管状,在所述扩张构型中,网状支撑框架在其中央部分处以扩张的中心直径进行径向扩张,而网状支撑框架的末端部分仍处于递送直径。扩张的中心直径可以是递送直径的至少两倍、递送直径的至少三倍、递送直径的至少四倍、递送直径的至少五倍等。覆盖物可覆盖网状支撑框架以防止血液从中穿过。扩张构型中的密封元件可包含轴对称的、细长的、或椭圆的顶部轮廓。
密封元件外覆盖物可优选地围绕密封元件的中心锚定部或任何其它支撑结构的外部和/或内部包裹,使得中心锚定部或其它支撑框架的线状(wireform)元件被密封元件覆盖和/或封装以防止天然瓣叶接触中心锚定部的任何框架元件。
根据本发明的实施方式的用于治疗二尖瓣的系统可具有递送导管、锚定构件、和假体密封构件。锚定构件可以是自扩张的和/或轴对称的,并且可具有用于接合心脏组织的多个可径向延伸的臂。密封构件可适合于填塞(plugging)二尖瓣的小叶之间的间隙并减少回流。假体密封构件可具有皱缩状态和扩张状态,其中在皱缩状态下密封构件比在扩张状态下更长且更细(thinner)。密封构件可具有由生物组织形成的外表面。密封构件的细长横截面轮廓可以是实心的,使得血液被迫围绕密封构件流动。
根据本发明的用于改善心脏瓣膜的功能的方法可涉及推进递送导管的远端至患者的二尖瓣膜或其它心脏瓣膜处的位置,其中在远端内是具有锚定构件和密封构件的假体装置。密封构件可被配置以扩张成减少通过二尖瓣的回流的构型。锚定构件可具有配置以扩张成与心房组织接合的上部、配置以扩张以支撑密封构件的中部、和配置以扩张成与心室组织接合的下部。锚定构件可具有接合心脏腔室的上部的上部、和配置以接合相同心脏腔室的下部的下部。锚定构件可以是可自扩张的,和/或由记忆材料形成,且可被以压缩状态安装在递送导管的远端内。方法可进一步包括在一个位置处从导管释放锚定构件上部,使得锚定构件上部接合期望的心脏组织;从导管释放密封构件;以及在一个位置处从导管释放锚定构件下部,使得锚定构件下部接合期望的心脏组织。该部署程序可以不同顺序进行,如首先释放锚定构件下部,然后密封构件,然后上部;或在释放下锚定部和上锚定部之前或之后释放密封构件。在部署锚定构件部分和密封构件之后,密封构件应被定位在二尖瓣的小叶之间,使得在收缩期期间,小叶抵靠密封构件进行接合。密封构件的长度和宽度可由使用者初始部署后进行调节以改善心脏瓣膜功能。可利用各种递送技术(如经皮或经心尖)将装置递送且部署至二尖瓣膜或其它心脏瓣膜。
本发明的方法可包括推进递送导管的远端至患者心脏中的心脏瓣膜(例如,二尖瓣)处的位置,其中在远端内是具有锚定构件和密封构件的假体装置,密封构件被配置以扩张成轴对称的或细长且对称的(例如,椭圆的)构型,以在收缩期期间接合天然二尖瓣小叶,同时仍允许天然二尖瓣小叶随着心跳打开和闭合;在心脏中的天然瓣环处或附近的位置处从导管释放锚定构件部分以接合心脏组织并将锚定构件锚定在心脏内;从导管释放密封构件;径向扩张密封构件,其中密封构件随着其扩张而缩短长度同时增加直径,其中扩张后的密封构件包含轴对称的或细长/椭圆的顶部轮廓。在释放锚定构件和密封构件后,密封构件被定位在二尖瓣的小叶之间,使得在收缩期期间,小叶抵靠密封构件进行接合并且小叶可随着心跳打开和闭合。
扩张后的密封构件可具有圆形的顶部轮廓、或细长的顶部轮廓(如椭圆的顶部轮廓)。可将密封构件围绕其中心轴线且相对于天然瓣环旋转至期望的旋转位置,其中密封构件在瓣环内与天然瓣膜特征对准以改善瓣叶抵靠密封构件的接合。该旋转可由使用者选择性地执行,并且使用者还可将密封构件锁定在期望的旋转位置处。对于细长的密封元件,围绕其中心轴线旋转密封构件可涉及将密封构件的长轴线对准,以与二尖瓣的连合之间的线大体上(在10度内)平行。
装置的部署可响应于瓣膜性能监视和/或可视化技术的反馈执行。例如,在扩张或旋转密封元件时,使用者可监视瓣膜性能,并且以基于瓣膜性能和/或可视化反馈而使瓣膜性能最大化的构型设置密封元件的最终扩张构型和/或旋转位置。
锚定构件可包含上部和下部。可包括中部,并且其被配置以支撑密封构件。在一个实施方式中,上部被配置以扩张成与心房组织接合,并且下部被配置以扩张成与心室组织接合。用于部署其的方法可包括将上部释放成与心房组织接合,将下部释放成与心室组织接合。在一个实施方式中,上部被配置以扩张成与上心房组织接合,并且下部被配置以扩张成与邻近天然瓣环的下心房组织接合。用于部署其的方法可包括将上部释放成与上心房组织接合,并且将下部释放成与下心房组织接合。从导管释放锚定构件上部可在从导管释放锚定构件下部之前、与其同时、或在其之后发生。
可利用各种路径(包括经皮地或经心尖地)将装置递送通过对象的脉管系统。
通过考虑以下详细描述,本发明的其它目的、特征、和优点将变得显而易见。
附图说明
图1是心脏的横截面图;
图2A-2D描绘了根据本发明的实施方式的修复装置部署在其中的心脏的侧横截面图;
图3A-3D描绘了根据本发明的实施方式的处于各种扩张状态的密封元件的侧视图;
图3E-3H描绘了图3A-3D中描绘的处于各种扩张状态的密封元件的俯视图;
图4A-4B分别描绘了根据本发明的实施方式的分别处于压缩和扩张构型的开槽管式(slotted-tube)密封元件框架的侧视图和立体图;
图5A-5C描绘了根据本发明的实施方式的处于各种扩张状态的编织网式密封元件的侧视图;
图6A-6D描绘了根据本发明的实施方式的处于各种扩张状态的密封元件的俯视图;
图7A-7C描绘了根据本发明的实施方式的用于控制密封元件的扩张的各种机构的立体图;
图8A描绘了根据本发明的实施方式的装置的立体图;
图8B-8C分别描绘了根据本发明的实施方式的锚定件的俯视图和仰视图;
图8D-8G描绘了根据本发明的实施方式的图8A的装置以各种状态部署在其中的心脏腔室的侧视图;
图9A描绘了根据本发明的实施方式的装置的侧视图;
图9B-9C分别描绘了根据本发明的实施方式的框架的俯视图和仰视图;
图9D-9G描绘了根据本发明的实施方式的图9A的装置以各种状态部署在其中的心脏腔室的侧视图;
图10A描绘了根据本发明的实施方式的装置的侧视图;
图10B-10E描绘了根据本发明的实施方式的图10的装置以各种状态部署在其中的心脏腔室的侧视图;
图11A-11C描绘了根据本发明的实施方式的各种部分被扩张的锚定框架的立体图;以及
图11D描绘了根据本发明的实施方式的具有处于扩张构型的图11A-11C的锚定元件的装置。
具体实施方式
图1中描绘了人类心脏10的横截面图。心脏10具有肌性心壁11、尖部(apex)19、和四个腔室:右心房12;右心室14;左心房16;和左心室18。血流由四个主瓣膜控制:三尖瓣20;肺动脉瓣22;二尖瓣24;和主动脉瓣26。血液通过上腔静脉28和下腔静脉30流到心脏10的右心房12中。右心房12将血液泵送通过三尖瓣20(以开放构型)并进入右心室14。然后右心室14将血液通过肺动脉瓣22泵送出并进入肺动脉32(其分支成通向肺的动脉),其中三尖瓣20闭合以防止血液从右心室14流回进入右心房。三尖瓣20的小叶的自由边缘经由右心室腱索34连接到右心室14中的右心室乳头肌36以控制三尖瓣20的运动。
离开肺后,氧合的血液流过肺静脉38并进入心脏10的左心房16。二尖瓣24控制左心房16和左心室18之间的血流。当血液从左心室18喷射到主动脉40中时,二尖瓣24在心室收缩期期间闭合。因此,二尖瓣24打开以用来自左心房16的血液再填充左心室18。二尖瓣24的小叶42a、42p的自由边缘经由左心室腱索44连接到左心室18的左心室乳头肌46以控制二尖瓣30。来自左心室18的血液通过主动脉瓣26泵送到主动脉40中,其分支成通向除肺以外身体所有部分的动脉。主动脉瓣26包括三个小叶48,其随着心脏跳动而打开和闭合以控制血液从心脏的左心室18流到主动脉40中。
图2A-2D描绘了根据本发明实施方式的部署在天然二尖瓣24和二尖瓣瓣环25中的装置50。装置50具有支撑锚定件52和密封元件54。支撑锚定件52可被配置以允许天然瓣叶42a、42p的自由运动。在图2A中,天然二尖瓣24处于舒张早期,其中天然小叶42a、42p开始打开并允许血液从左心房16流动以填充左心室18。在如图2B中所描绘的整个舒张期中,二尖瓣小叶42a、42p完全打开。在如图2C中所描绘的收缩早期中,向左心房16中的最初向后流动将二尖瓣小叶42a、42p推回(向上)并推成彼此接合,并且与密封元件54接合。在如图2D中描绘的完全收缩期中,所述天然二尖瓣小叶42a、42p在峰值收缩压下紧紧地抵靠密封元件54包裹,有效消除任何回流(regurgitation flow)。
根据本发明的实施方式的密封元件60描绘于图3A-3D和3E-3H中。密封元件60具有完全压缩状态,描绘于图3A和3E中,这可用于经由导管递送,并且其中密封元件60可以大体上是管状的并且具有最初/递送长度62a和最初/递送最大直径64a。可通过缩短长度62b、62c扩张密封元件60,因而迫使密封元件最大直径64a、64b增加,如图3B-3C和3F-3G中描绘。密封元件60可达到在图3D和3H中描绘的其部署长度62d和部署最大直径64d。根据本发明的密封元件60可具有15-60mm;40-50mm;30-55mm等之间的最初/递送长度62a。密封元件60可具有0-10mm;5-8mm;6mm;等之间的最初/递送最大直径64a。根据本发明的密封元件60可具有20-45mm;25-35mm;约30mm等之间的部署长度62a,和5-40mm;10-30mm;15-25mm等之间的部署最大直径64a。高度/长度与直径的比率根据具体应用而变化。高度/长度与直径比率的示例性范围是:10:1、或5:1、或3:1和其之间的范围(在递送期间);以及1:4、或1:2、或1:1、或2:1和其之间的范围(部署时)。注意,具体密封元件尺寸(例如,递送直径、部署直径、递送高度/长度、部署高度/长度等)的这些比率和范围中的每个可与根据本发明的任意和所有其它密封元件尺寸组合。
根据本发明的密封元件和/或锚定元件可包括不透射线的或其它可视化标记以增强使用者对该装置的可视化。例如,在图3A-3F的实施方式中,包括不透射线的或其它可视化标记63、65。标记63朝向密封元件的末端部分定位,可用于可视化密封元件的高度/长度。周边标记65朝向密封元件周边靠近其最宽点进行定位,并且可用于可视化密封元件的直径。所有标记还可用于监视密封元件的位置。
密封元件60可具有扩张控制元件66,其长度可被调节以由此控制总长度并由此控制密封元件的扩张。密封元件60可优选地具有密封表面(未示出),其可以是防止血液从其中通过的外覆盖物的形式。密封表面可被可扩张的支撑框架(未示出)支撑。注意,在图3A-3D中描绘的实施方式中,扩张控制元件66对应于密封元件60的中心轴线,在部署期间和扩张后密封元件60可以是围绕该中心轴线轴对称的。
在图4A和4B中描绘了根据本发明的实施方式的处于所谓的“开槽管式(slottedtube)”构型的可扩张的支撑框架70。如图4A中所示,在其压缩/递送构型中,支撑框架70包含大体上圆柱形主体72、以及递送长度74a和递送最大直径76a。支撑框架70构造(其中隙缝78在肋状元件80之间)允许支撑框架70径向扩张,其中肋状元件80向外弯曲,支撑框架70达到部署长度74b和部署最大直径76b,如图4B中描绘的。注意,部署长度74b小于递送长度74a,而部署最大直径76b大于递送最大直径76a。递送构型有益于经由导管递送到人类心脏中。将密封表面(未示出)(如以外覆盖物的形式)添加到支撑框架70将产生根据本发明的实施方式的密封元件。支撑框架70的扩张可经由机构(如系绳(tethers)、棘轮(ratchets)等)实现,和/或可涉及由形状记忆材料(如镍钛诺)构造支撑框架70。
根据本发明的实施方式的支撑框架90可包括图5A-5C中描绘的编织网式套筒,其中束92(如线或其它束状元件)被编织或以其它方式形成为网状结构,从而限定通常的管状结构94。网状结构当其长度被压缩时可引起框架90径向扩张,且当其长度减小时可引起框架90径向缩小(以用作儿童玩具的可收缩的指套(finger traps)的类似式样)。支撑框架90具有远端96和近端98,具有长度100a、100b、100c和最大直径102a、102b、102c。远端96和近端98的直径104、106可被大体上固定,使得即使最大直径扩张,也防止支撑框架90的该部分明显地径向扩张。随着支撑框架90的长度从其递送长度100a减小到其部署长度100c,支撑框架90的最大直径从其递送最大直径102a增加到其部署最大直径102c。注意,根据支撑框架如何形成(例如,束92如何编织、使用材料等),即使中部108和支撑框架90径向扩张,支撑框架90的中部108也可保持大体上管状的形状。在其它实施方式中,支撑框架90可形成更加球形的形状,甚至形状具有围绕框架90的圆周的变化的径向尺寸。将密封表面(未示出)(如以外覆盖物的形式)添加到支撑框架90将产生根据本发明的实施方式的密封元件。支撑框架90的扩张可经由机构(如系绳、棘轮等)实现,和/或可涉及由形状记忆材料(如镍钛诺)构造支撑框架00。
当从顶部观察时,根据本发明的支撑框架和密封元件可被配置以形成非圆形轮廓。例如,在图6A-6D的实施方式中,密封元件110在递送和扩张期间可具有类似于图3A-3D中描绘的侧轮廓,但当部署时不具有如图3E-3H中描绘的圆形的顶部轮廓,而是形成细长的/椭圆的顶部轮廓,其中当密封元件110如图6D中描绘的完全扩张时,大直径112d远大于小直径114d。这种非圆形的/椭圆的密封元件可包括不透射线的或其它可视化标记115、117(例如,朝向密封元件周边并沿着/邻近长轴线115和/或短轴线117定位),使用者通过它们不仅可以可视化密封元件的尺寸(大直径和/或小直径),而且可以可视化密封元件围绕其中心轴线和相对于锚定元件和/或天然瓣膜的旋转方向。在递送期间,最大直径可在0-10mm;5-8mm;6-7mm等之间。扩张的小直径114d可在5-20mm;10-15mm等之间,而扩张的大直径112d可在10-40mm;15-40mm;20-30mm等之间。
密封元件的扩张可经由各种机构的使用来控制。例如,如图7A中描绘的,内部栓系机构120可包含系绳线(tether line)122,系绳线122具有可被固定到支撑框架(未示出)的一端的第一端124和可穿过支撑框架的相对端的第二端126。通过拉扯第二端126,从而缩短位于支撑框架内的内部系绳的长度,支撑框架在长度上减小并径向扩张。内部栓系机构可包括支撑框架的相对端处的锁,如结、单向锁、或其它锁定机构(未示出),以将内部系绳固定在对应于部署地密封元件的期望的形状(即,最大直径/长度)的期望长度。这种系绳可与本发明的任意和所有密封元件和支撑框架一起使用,并且可对于具有自扩张支撑框架的密封元件特别有用,其中系绳用于保持和控制支撑框架的扩张。
根据本发明的密封元件的扩张可由抵抗张力和压缩力(compression)的通常刚性杆130控制,如图7B中所描绘。杆130的第一端132可被固定到支撑框架(未示出)的第一端,其中杆130在支撑框架的第二端处穿过锁定机构134,其中杆130的第二端134在距第一端132的锁定机构的远侧。杆130可包含由锁定机构134选择性地接合的齿状元件136。例如,锁定机构134可允许齿状元件向外穿过锁定机构(如可期望缩短杆130,从而缩短并径向扩张支撑框架),但防止齿状元件向内穿过锁定机构。
用于控制密封元件的扩张的另一种选择是线性螺杆机构140,其中细长的螺杆142具有固定到支撑框架(未示出)的第一端的第一端144。螺杆接收螺母146经由延伸部148固定到支撑框架的第二端。螺杆接收螺母146或螺杆第一端144可旋转地固定到支撑框架,允许螺杆相对于螺杆接收螺母旋转,从而通过螺杆接收螺母146推进/缩回螺杆142,并且调节线性螺杆机构的长度和支撑框架的长度/扩张。
图8A描绘了被配置用于部署的装置150的立体图,其中部分被固定在患者的心房、心室、和瓣环中。锚定元件152锚定并支撑密封元件154。锚定元件152具有心房部分156,所述心房部分156具有终止于心房臂远端160的心房臂158,其中心房臂158的尺寸和形状被设置以延伸穿过心房的下部并从心房侧接合瓣环。心室部分162具有终止于心室臂远端166的心室臂164。心室臂164的尺寸和形状可被设置成围绕“摆动(swing)”区域延伸,天然瓣叶随着心跳通过该“摆动”区域摆动,以在瓣叶打开和闭合(shut)时不接合抵靠天然瓣叶。心室臂164围绕小叶摆动区域弯曲(curve),然后向上弯曲回以从心室侧接合瓣环。注意,如图8B-8C中所示,当直接从上放或下方观察时,当在空气中扩张或以其它方式在不存在压缩力(如当部署在心脏时可能存在的压缩力)的情况下扩张时描绘的锚定元件152是轴对称的,使得在部署期间,外科医生或其它使用者不必担心该装置150的锚定元件152是否围绕其中心轴线旋转至相对于天然瓣膜和瓣环的适当部署位置。在描绘的具体实施方式中,上锚定元件156的扩张直径161稍微大于下锚定元件162的扩张直径167,尽管本发明不限于该构型。下锚定件扩张直径167可在25和60mm之间,而上锚定件扩张直径161可在30和70mm之间。注意,挡在真实心脏中扩张时,上锚定元件156和下锚定元件162的单独的臂158、164将通过它们与心脏组织相互作用而被压缩或以其它方式变形,使得每个臂可被心脏组织扭曲成稍微不同于其它臂的形状的形状。
图8A的锚定元件152包含穿过密封元件154的中部168。中部168可被配置以充当密封元件的支撑框架,和/或可被配置以被缩短(例如,通过并入如图7A-7C中的那些缩短机构),以完成(effectuate)密封元件154的缩短并由此扩张。在描绘的具体实施方式中,密封元件中部168围绕密封元件154和锚定元件152的轴线。注意,密封元件154的顶部轮廓(即,围绕其中心轴线)可以是如图3E-H中的轴对称的(例如,圆形的),可以是如图6A-6D中非圆形的(例如,椭圆的)。密封元件154,尤其如果其顶部轮廓是非圆形的/椭圆的,可被配置用于相对于锚定元件152轴向旋转(选择性地或响应于身体运作,如血流/瓣膜运作),并且可提供锁,该锁可被激活以防止密封元件154相对于锚定元件152进一步旋转。在这种旋转的情况下,外科医生或其它使用者可部署轴对称的锚定元件并确认锚定元件的适当部署(经由直接或间接观察,例如,放射检查),然后将密封元件旋转至期望的旋转位置,然后将该密封元件锁定在期望的位置。
图8D-8G描绘了左心房16、左心室18、二尖瓣24、和二尖瓣瓣环25的侧视图,其中根据本发明的实施方式装置150以各种状态部署在其中。如图8D中,装置150被固定在递送导管172的远端170内,并且远端170经由心脏10的左心房16被经皮地或微创地推进到患者的二尖瓣24中。在图8E中,心室锚定部166从导管172释放并扩张成在二尖瓣24下方与心脏组织接触。在图8F中,密封元件154和中心锚定部168被定位在二尖瓣24的小叶42a、42p之间。此时,密封元件154可被扩张,或者扩张可不发生直到部署心房锚定部156后。尽管在图8F中,密封元件被描绘为扩张的,注意,其扩张可在部署心房锚定部之后发生。在图8G中,在装置150从导管172完全释放时,心房锚定部156被扩张成在二尖瓣24上方与心脏组织接触。
在确认装置150的位置和作用的情况下(如经由放射检查和/或远程观察的其它方法),然后将导管172从患者抽出。尽管描绘了经由心房侧的经皮递送,但是注意,其它部署路径也在本发明范围内,包括经心尖路径。
图9A描绘了被配置用于部署的装置180,其中锚定部被完全固定在患者的心房中。锚定元件182锚定并支撑密封元件184。锚定元件182具有上心房部分186,其中上心房臂188终止于上心房臂远端190。上心房臂188的尺寸被设置且被配置以向上弯曲通过心房的中央并向外弯曲以接合心房的上表面。上心房臂188可包括可充当缓冲器的中间弯曲部189,其挠曲并弯曲以允许锚定元件182响应于心房形状随着心跳的变化而被压缩。下心房部分192具有终止于下心房臂远端196的下心房臂194。下心房臂194的尺寸和形状可被设置成向外延伸并穿过心房的下部,并且从心房侧接合瓣环。注意,当在不存在压缩力或其它变形力的情况下扩张时,描绘的锚定元件182可以是轴对称的,使得在部署期间,外科医生或其它使用者不必担心装置180的锚定元件182是否围绕其中心轴线旋转至相对于天然瓣膜和瓣环的适当部署位置。例如,当在没有压缩力/变形力的情况下扩张时(例如,在空气中扩张),当从上方或下方观察时,锚定元件182是对称的,如图9B-9C中描绘的。在描绘的具体实施方式中,虽然上锚定元件186的扩张直径191总体上等同于下锚定元件192的扩张直径197,但是其它直径也在本发明的范围内。上锚定件扩张直径191和下锚定件扩张直径可以在30和70mm之间的范围中。注意,当在真实心脏中扩张时,上锚定元件186和下锚定元件192的单独的臂188、194将通过它们与心脏组织的相互作用被压缩或以其它方式变形,使得每个臂可被心脏组织扭曲成稍微不同于其它臂的形状的形状。
图9A的锚定元件182包括密封元件支撑部分200,其在心房部分186、192下方穿过密封元件184,并被配置以在其它锚定部186、192已被部署在期望的心脏腔室(如描绘的左心房16)中之后,将密封元件184保持在天然瓣环内期望的位置。在描绘的具体实施方式中,密封元件支撑部分200对应于密封元件184的轴线和锚定元件182的轴线。密封元件支撑部分200可被配置以充当密封元件184的支撑框架,和/或可被配置以缩短(例如,通过并入缩短机构,如图7A-7C中的那些),以完成密封元件184的缩短并由此扩张。注意,密封元件184的顶部轮廓(即,围绕其中心轴线)可以是如图3E-H中的轴对称的(例如,圆形的),或可以是如图6A-6D中的非圆形的(例如,椭圆的)。密封元件184(尤其其顶部轮廓是非圆形的/椭圆的)可被配置用于相对于锚定元件182轴向旋转(选择性地或响应于身体运作,如血流/瓣膜运作),并且可提供锁,所述锁可被激活以防止密封元件184相对于锚定元件182的进一步旋转。由于这种旋转,外科医生或其它使用者可部署轴对称的锚定元件并确认锚定元件的适当部署(经由直接或间接观察,例如,放射检查),然后将密封元件旋转至期望的旋转位置,然后将该密封元件锁定在期望的位置。
如在图9D-9G中描绘的,装置180可经由经心尖路径部署到心脏10中。装置180被固定在递送导管202的远端204内,并且将导管远端204经由心壁11中的开口206(例如,经由左心室18的壁中的开口,如在尖部处的经心尖开口)进行推进并进入患者的二尖瓣24中。在图9E中,当装置180开始从导管202释放时,上心房锚定部186被扩张成朝向左心房16的上部区域与心脏组织接触。在图9F中,下心房锚定部192从递送导管202释放,并且扩张成与心房16的下部接触。图9G描绘了定位在二尖瓣24的小叶之间的密封元件184和密封元件支撑部分200,并且密封元件184在其之间扩张。装置180从导管202完全释放。在确认装置180的位置和作用的情况下(如经由放射检查和/或其它远程观察方法),然后导管202可从患者抽出,并且开口206经由缝线208和/或其它用于关闭开口的方法/装置进行闭合。
图10A描绘了装置210,所述装置210具有经由系绳214和锚定件216锚定的密封元件212。装置210可被定位在递送导管220的远端218中并且被推进到心脏中。在一种实施方式中,将装置210经心尖地推进到左心室18中并经由心壁中的开口222推进至二尖瓣24,其中开口222可以在心脏尖部19处,如图10B中描绘的。密封元件212可在天然瓣叶42a、42p之间的位置处从导管216释放,如图10C中描绘的。图10D描绘了当系绳214从导管远端218释放时抽出的导管220,其中系绳214根据期望的应用是刚性的或柔性的。当导管从心脏10移除时,锚定件216被部署在心壁11中,如图10E中所示。然后使用者可在将系绳214在期望的长度处锁定至锚定件216之前调节系绳214的长度。注意,在期望的系绳长度处将系绳214锁定至锚定件可通过已知方法(如经由滑动锁定机构)来实现,滑动锁定机构最初允许系绳滑动通过锁,然后经由系绳线中的结等防止进一步运动。
注意,密封元件212可在部署期间的各种时间选择性地完全或部分扩张,各种时间如在最初从递送导管释放时;在系绳被延伸后;在锚定件被固定后;或在系绳长度被最终确定(finalized)后。系绳长度也可在各种时间调节。例如,当从导管释放时密封元件212可部分扩张,而仅在系绳长度被最终确定之前或最终确定时发生完全扩张,以经由放射检查等确认瓣叶相对于密封元件的适当密封。尽管描绘了经由心室和心尖经心尖递送,但是注意,其它部署途径也在本发明的范围内,包括经由血管和/或心房侧的经皮方法。
根据本发明的锚定框架230可由记忆材料(如镍钛诺)形成,和/或可具有中部232,所述中部232被配置以充当密封元件的支撑框架。例如,如图11A中描绘的,框架230形成为具有中部232、上部234、和下部236的形状记忆材料的大体上管状形式,其中每个部分由肋状元件240a-c之间的隙缝238a-c组成。可通过如图11B中描绘的向外弯曲肋状元件240b来将中部232径向扩张成期望的形状,并且期望的形状可经由已知方法设置在记忆材料中。上部234和下部236可类似地形成如图11C中的期望的形状,并且将期望的形状设置到记忆材料。注意,肋状元件240a-c被配置以延伸出以形成臂和其它框架/锚定件结构。将流体阻塞(fluid-blocking)覆盖物242添加至框架中部232产生了密封元件244。注意,在密封元件部分中装置可具有顶部开口246和/或下部开口248,其允许一些血液流入和流出密封元件但避免血液在其中淤积(pooling)。替代地,密封元件部分的顶部和底部之一或两者可完全闭合。
根据本发明的锚定框架可由各种生物相容性材料(包括金属和聚合物)形成。例如,可使用记忆材料(如镍钛诺),从而形成锚定框架,该锚定框架可压缩到导管上/中用于微创/经皮递送,然后在从导管释放后将扩张成其“记忆的”形状。非记忆材料(如不锈钢或钴铬)也在本发明的范围内。锚定框架可包含生物相容性覆盖物,如涤纶(Dacron)或其它织物。生物相容性覆盖物可支持组织向内生长以促进组织锚定。生物相容性覆盖物可替代地抵抗组织向内生长。
根据本发明的密封元件可由各种生物可相容性材料(包括金属、织物、塑料、和组织)形成。可用于这种密封元件的一些材料包括当前用于形成假体心脏瓣膜的小叶的材料。例如,可使用合成材料(例如,聚合物,如热塑性弹性体或树脂,包括聚氨酯和硅酮等)、天然/处理过的组织(例如,瓣叶组织、牛或马心包等)、织物(例如,涤纶)等。
密封元件可优选地围绕用于直接支撑密封元件或为密封元件制定框架的任何锚定部的外部和/或内部包裹,使得支撑框架部分的任何线状/肋状元件被密封元件材料覆盖和/或封装,以防止天然瓣叶接触密封元件支撑框架的任何框架元件等。
在根据本发明部署装置期间(如在图8D-8G或9D-9G或10B-10E中描绘的部署程序),外科医生或其它使用者可可控制地将密封元件扩张至期望的直径/长度,或者如在从递送导管释放后,密封元件可被配置以自扩张至预设的构型。例如,如果密封元件包括记忆材料(例如,镍钛诺)支撑框架,则再从径向约束(如递送导管的递送腔)释放后,支撑框架可自动扩张至预设的记忆材料构型(长度/直径)。可选地,外科医生或其它使用者可主动地控制将密封元件扩张至具体选择的直径/长度,如通过激活长度/直径调节元件,如图7A-7C中描绘的那些。在密封元件扩张之前、期间和/或之后,外科医生/使用者可经由各种技术(如荧光检查法(fluoroscopy)或其它可视化技术(包括在密封元件上使用不透射线的标记))主动监视心脏瓣膜功能和/或小叶(与密封元件)接合和/或密封元件位置/尺寸。外科医生/使用者可基于对心脏瓣膜功能和/或小叶接合的信息选择密封元件的最终直径/长度。外科医生/使用者也可相对于支撑锚定件围绕密封元件的中心轴线选择性地旋转密封元件(在部署支撑锚定件之前、期间或之后),以更好地将密封元件定位在天然瓣叶之间,如其中密封元件具有如在图6A-6D中描绘的椭圆的顶部轮廓。例如,用这种椭圆轮廓的密封元件,使用者可部署锚定元件,然后相对于锚定元件和天然瓣膜旋转(扩张的或未扩张的)密封元件,以将小直径定位成大体上垂直于前和后二尖瓣小叶延伸,并且将大直径定位成在瓣膜连合点之间延伸。在达到期望的旋转位置后,密封元件可被锁定在该位置。
如果使用者(例如,外科医生或其它医务人员)对所有或部分装置的最初定位不满意,装置或其部件(parts)可被(完全或部分)抽出到导管中,然后重新部署在期望的位置。例如,如果初始部署后,密封元件相对于二尖瓣小叶被定位太高或太低,则装置或其部件可至少部分地抽出到导管中,然后重新部署在比先前位置更高或更低的位置。类似地,如果使用者对密封元件的部署尺寸不满意,他/她可调节密封元件的长度/半径直到实现与天然小叶的期望的密封/接合。而且,对于顶部轮廓为非圆形的/椭圆的密封元件,使用者可将密封元件的旋转位置修改成可优化瓣膜功能的期望的旋转位置。
装置可包含不透射线的标记或其它可见度增强标记,以使当利用荧光检查法或其它可视化技术部署或检查装置时,装置和其关键元件(key elements)更清晰可见。例如,增强的可见度标记(如不透射线的标记)可被固定到密封元件和/或锚定元件的部分等。
注意,图3B-3D、8E、9A、和11A-11D是计算机生成的比例图,其中尺寸在每个图内是按比例的(to scale)。列出的所有尺寸都是举例说明,并且根据本发明的装置可具有具体数值和范围之外的尺寸。尽管在一些附图中,密封元件材料被描绘为在框架部分之间延伸,但框架部分未覆盖,在本发明的各种实施方式(包括在附图中描绘的本发明的每个实施方式)中,密封元件材料可优选地围绕支撑框架部分的外部和/或内部包裹,使得线状/肋状框架元件被密封元件材料覆盖和/或封装,以防止天然瓣叶接触任何框架元件。
尽管以上讨论的具体实施方式针对二尖瓣修复,本发明也可适用于修复其它心脏瓣膜(包括主动脉瓣、三尖瓣、和肺动脉瓣)。
除非另有注释,否则本文使用的所有技术和科学术语具有与由本公开所属领域普通技术人员通常理解的相同含义。为了促进回顾各本公开的种实施方式,提供了以下术语的说明:
除非上下文明确指出,否则单数术语“一(a和an)”和“该”包括复数指示物(referents)。除非上下文明确指出,否则术语"或"是指规定的替代元件的单个元件或两个或更多个元件的组合。
术语“包括”意指“包含”。例如,包括或包含A和B的装置含有A和B,但可可选地含有除了A和B以外的C或其它组件。此外,包括或包含A或B的装置可含有A或B或者A和B,并且可选地含有一个或多个其它组件(如C)。
术语“对象”是指人类和其它动物对象。在某些实施方式中,对象是人类或其它哺乳动物,如灵长类、猫、狗、母牛、马、啮齿类动物、绵羊、山羊、或猪。在具体实例中,对象是人类患者。
尽管与本文描述的那些类似或等同的方法和材料可被用于本公开的实践或测试,但是下面描述了合适的方法和材料。在发生冲突的情况下,以本说明书(包括术语)为准。另外,材料、方法、和实例仅是示例性的,并不意图是限制性的。
鉴于可应用所公开的发明的原理的很多可能的实施方式,应当认识到,所示例的实施方式仅是本发明的实例,而不应被认为是本发明的范围的限制。相反,本发明的范围由以下权利要求限定。我们因此将在这些权利要求的范围和精神内的所有内容称为我们的发明。
Claims (38)
1.用于治疗二尖瓣的装置,其包含:
假体密封元件,所述假体密封元件具有轴对称的或椭圆的顶部横截面轮廓,所述密封元件的尺寸被设置以被部署在天然二尖瓣小叶之间的位置处的心脏天然二尖瓣的瓣环中,以在心室收缩期期间接触所述天然二尖瓣小叶,从而产生防止血液从左心室回流至左心房的密封,其中所述密封元件包含递送构型,其中所述密封元件是大体上细长的和径向皱缩的,并且进一步包含部署构型,其中所述密封元件被缩短并径向扩张成轴对称的或椭圆的顶部横截面轮廓,且其尺寸进一步设定以允许所述天然二尖瓣小叶随着心跳打开和闭合;以及
锚定元件,所述锚定元件适合于部署在所述心脏中,所述锚定元件被耦接至所述密封元件并被配置以在天然瓣叶之间的期望的位置处支撑所述密封元件,其中所述锚定元件的尺寸被设置以当所述锚定元件被部署在所述心脏中时,将所述密封元件定位在所述天然二尖瓣小叶之间。
2.权利要求1所述的装置,其中所述锚定元件包含配置以延伸成与心脏组织接触的上部,和配置以延伸成与心脏组织接触的下部。
3.权利要求2所述的装置,其中锚定元件上部被配置以通过延伸成与邻近二尖瓣瓣环的心房组织接触来锚定在所述心脏中,并且锚定元件下部被配置以通过延伸成与邻近所述二尖瓣瓣环的心室组织接触来锚定在所述心脏中。
4.权利要求2所述的装置,其中锚定元件上部被配置以通过延伸成朝向心房的顶部与心房组织接触来锚定在所述心脏中,并且锚定元件下部被配置以通过延伸成与邻近所述二尖瓣瓣环的心房组织接触来锚定在所述心脏中。
5.权利要求1所述的装置,其中所述锚定元件包含在25和70mm之间的扩张直径。
6.权利要求1所述的装置,其中所述密封元件包含小于10mm或更小的递送直径、和10至35mm的扩张直径。
7.权利要求1所述的装置,其中所述密封元件在扩张时是细长的,并且所述密封元件包含小于10mm或更小的递送直径、和10至35mm的扩张大直径和5至15mm的扩张小直径。
8.权利要求1所述的装置,其中所述锚定元件在没有径向压缩力的情况下扩张时是轴对称的。
9.权利要求1所述的装置,其中所述锚定元件包含记忆材料。
10.用于治疗心脏瓣膜的系统,其包含:
递送导管;
假体装置,所述假体装置包含:
锚定构件,所述锚定构件被配置以接合邻近天然心脏瓣膜的心脏组织,其中所述锚定构件是可皱缩的和可扩张的,其中所述锚定构件被配置使得当在没有径向压缩力的情况下扩张时,所述锚定构件的顶部轮廓是轴对称的;以及
假体密封构件,所述假体密封构件是可皱缩的和可扩张的,且所述假体密封构件在处于扩张构型时包含轴对称的或椭圆的顶部轮廓,其中所述锚定构件被配置以从拉长的且径向压缩的构型扩张至缩短的且径向扩张的构型,处于扩张状态的所述密封构件适用于填塞在所述心脏瓣膜的小叶之间的间隙并减少回流,其中处于所述扩张状态的所述密封构件适于在收缩期期间接合天然瓣叶,同时允许所述天然瓣叶随着心跳打开和闭合;
其中所述锚定构件和所述假体密封构件被配置以以皱缩状态定位在所述递送导管内。
11.权利要求10所述的系统,其中所述密封构件被配置以相对于所述锚定构件围绕轴线旋转。
12.权利要求11所述的系统,其中所述密封构件被配置以相对于所述锚定构件选择性地旋转,并且所述假体装置包含锁,所述锁被配置以选择性地将所述密封构件相对于所述锚定构件锁定在选择的旋转点。
13.权利要求10所述的系统,其中所述锚定构件包含上部和下部,其中所述上部适于接合邻近所述天然瓣膜的心房组织,并且所述下部适于接合邻近所述天然瓣膜的心室组织。
14.权利要求10所述的系统,其中所述递送导管包含远侧开口,并且所述锚定构件和所述假体密封构件被配置以以皱缩状态在所述导管远侧开口中推进并且从所述导管远侧开口中推出。
15.用于改善心脏瓣膜的功能的方法,其包括:
将递送导管的远端推进至患者心脏中的心脏瓣膜处的位置,其中在所述远端内是具有锚定构件和密封构件的假体装置,所述密封构件被配置以扩张成对称构型以在收缩期期间接合天然瓣叶,同时仍允许所述天然瓣叶随着心跳打开和闭合;
在天然瓣环处或其附近的心脏中的位置处从所述导管释放所述锚定构件部分,以在所述心脏内接合心脏组织并锚定所述锚定构件;
从所述导管释放所述密封构件;
扩张所述密封构件,其中所述密封构件在其扩张时缩短长度,同时增加直径,其中在扩张后所述密封构件包含轴对称的或椭圆的顶部轮廓;以及
借此在释放所述锚定构件和所述密封构件后,所述密封构件被定位在瓣叶之间,使得在收缩期期间,小叶接合抵靠所述密封构件,并且小叶可随着心跳打开和闭合。
16.权利要求15所述的方法,其中在扩张后所述密封构件包含轴对称的顶部轮廓。
17.权利要求15所述的方法,其中所述心脏瓣膜是二尖瓣,并且其中在扩张后所述密封构件包含椭圆的顶部轮廓。
18.权利要求17所述的方法,进一步包括:
将所述密封构件围绕其中心轴线并相对于天然瓣环旋转至期望的旋转位置,其中所述密封构件在所述天然瓣环内且与天然瓣叶对准,以改善瓣叶接合抵靠所述密封构件;以及
将所述密封构件锁定在期望的旋转位置处。
19.权利要求18所述的方法,其中围绕密封构件的中心轴线旋转所述密封构件包括对准所述密封构件的长轴线以大体上平行于(在10度内)二尖瓣的连合之间的线。
20.权利要求15所述的方法,进一步包括:
监视瓣膜性能同时扩张所述密封元件;以及
将所述密封元件的最终扩张构型设置为瓣膜性能被最大化的构型。
21.权利要求15所述的方法,其中所述锚定构件包含上部和下部,并且所述上部和所述下部被分开部署。
22.权利要求21所述的方法,其中从所述导管释放锚定构件下部发生在从所述导管释放锚定构件上部之前。
23.权利要求21所述的方法,其中从所述导管释放锚定构件上部发生在从所述导管释放锚定构件下部之前。
24.权利要求21所述的方法,其中锚定构件上部包含心房部分,所述心房部分被配置以接合邻近二尖瓣的瓣环的心房组织,并且锚定构件下部包含心室部分,所述心室部分配置以接合邻近二尖瓣的瓣环的心室组织。
25.权利要求21所述的方法,其中所述锚定构件被配置以部署在心房中,其中锚定构件上部朝向心房的顶部接合组织,并且锚定构件下部朝向心房的底部并邻近天然瓣环接合组织。
26.权利要求15所述的方法,其中所述锚定构件包含配置以扩张成与心房组织接合的上部、配置以扩张以支撑所述密封构件的中部、和配置以扩张成与心室组织接合的下部,其中部署所述锚定构件包括:
释放所述上部以与心房组织接合;以及
释放所述下部以与心室组织接合。
27.权利要求15所述的方法,其中所述锚定构件包含可自扩张的框架,所述可自扩张的框架以压缩状态被安装在在所述递送导管的远端内。
28.权利要求15所述的方法,其中所述锚定构件和所述密封构件被经皮地递送通过患者的脉管系统。
29.权利要求15所述的方法,其中所述锚定构件和所述密封构件被经心尖地递送至所述天然瓣膜。
30.权利要求15所述的方法,其中所述锚定构件包括扩张构型,其中在没有径向压缩力的情况下,所述锚定构件具有轴对称的顶部轮廓。
31.权利要求30所述的方法,其中所述锚定构件包括扩张构型,其中在没有径向压缩力的情况下,所述锚定构件具有细长的顶部轮廓。
32.权利要求15所述的方法,其中所述假体装置在部署后不向外扩张天然瓣叶或天然瓣环,除了在收缩期期间将天然瓣叶抵靠所述密封构件进行接合。
33.一种密封元件,所述密封元件被配置用于锚定在天然瓣叶之间以改善瓣膜功能,所述密封元件包含:
网状支撑框架,所述网状支撑框架包括递送构型和扩张构型,其中处于所述递送构型时,所述网状支撑框架是大体上管状的,具有递送直径,并且其中处于所述扩张构型时,所述网状支撑框架在其中央部分径向扩张成扩张的中心直径,而所述网状支撑框架的末端部分仍处于递送直径,其中所述扩张直径是所述递送直径的至少两倍;以及
所述网状支撑框架上的覆盖物,其中所述覆盖物防止血液从其中通过。
34.权利要求33所述的密封元件,其中所述扩张的中心直径是所述递送直径的至少三倍。
35.权利要求33所述的密封元件,其中所述扩张的中心直径是所述递送直径的至少五倍。
36.权利要求33所述的密封元件,其中处于所述扩张构型的所述密封元件包含轴对称的顶部轮廓。
37.权利要求33所述的密封元件,其中处于所述扩张构型的所述密封元件包含细长的顶部轮廓。
38.权利要求37所述的密封元件,其中处于所述扩张构型的所述密封元件包含椭圆的顶部轮廓。
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EP3678597A2 (en) | 2020-07-15 |
CA3073824A1 (en) | 2019-03-14 |
JP2023153158A (ja) | 2023-10-17 |
SG11202001503SA (en) | 2020-03-30 |
CN114617678A (zh) | 2022-06-14 |
US11065117B2 (en) | 2021-07-20 |
JP2020533076A (ja) | 2020-11-19 |
WO2019051031A2 (en) | 2019-03-14 |
US20210338427A1 (en) | 2021-11-04 |
US20190076247A1 (en) | 2019-03-14 |
WO2019051031A3 (en) | 2019-04-18 |
CN111212614B (zh) | 2022-05-03 |
EP3678597A4 (en) | 2021-08-25 |
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