CN101415379A - 用于输送医疗植入物的系统和方法 - Google Patents

用于输送医疗植入物的系统和方法 Download PDF

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CN101415379A
CN101415379A CNA2007800116769A CN200780011676A CN101415379A CN 101415379 A CN101415379 A CN 101415379A CN A2007800116769 A CNA2007800116769 A CN A2007800116769A CN 200780011676 A CN200780011676 A CN 200780011676A CN 101415379 A CN101415379 A CN 101415379A
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CN101415379B (zh
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A·萨兰希
J-P·杜里
H·F·瓦伦查
D·希尔德布兰
B·D·布兰特
D·P·莫尔约翰
C·阿吉恩托
T·索尔
U·R·豪格
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Boston Scientific Scimed Inc
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Sadra Medical Inc
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Abstract

本发明涉及用于在患者自体心脏瓣膜内和/或穿过患者自体心脏瓣膜在血管内输送并释放假体例如主动脉假体的设备和方法,在下文中提及时称作替换患者的心脏瓣膜。在一些实施方式中,输送系统包括多个第一可致动元件,所述可致动元件能够以第一结构接合多个第二元件来捕获输送系统内的植入物,且其中多个第一可致动元件能够以第二结构接合多个第二元件并从输送系统中释放植入物。

Description

用于输送医疗植入物的系统和方法
相关申请的交叉引用
本申请要求2006年2月14日提交的申请号为60/743,288的美国临时申请的优先权,该申请由此通过全文引用并入本文。
通过引用并入本文的内容
本说明书中提及的所有公开文献和专利申请在此均通过引用并入本文,其引用程度就如同将每一个单独的公开文献或专利申请明确且单独地声明通过引用并入本文一样。
背景技术
心脏瓣膜手术被用于修复或替换病变的心脏瓣膜。瓣膜手术是一种在全身麻醉下进行的心脏直视手术。通过患者的胸骨切开一个切口(胸骨切开术),然后患者的心脏停止跳动同时血流通过心肺呼吸机进行循环。
在自体心脏瓣膜变窄时,通常被称作狭窄,或者在自体瓣膜泄漏或返流时,可能会建议进行瓣膜替换。在替换瓣膜时,自体瓣膜被切除并替换为生物瓣膜或机械瓣膜。机械瓣膜需要终身使用抗凝药物以防止血凝块的形成,而且经常可以通过胸腔听到瓣膜的喀喇音。生物组织瓣膜通常不需要使用这样的药物。组织瓣膜可以从尸体获得或者可以是猪或牛的瓣膜,并通常被连接至人造环,人造环被固定至病人的心脏。
瓣膜替换手术是一种伴随有高风险的高创手术。风险包括出血、感染、中风、心脏病发作、心律不齐、肾衰竭、对麻醉剂的不良反应,以及突然死亡等。2%-5%的患者在手术期间死亡。
术后,由于和心肺机相关联的栓塞和其他因素的影响,患者可能会临时性地神智不清。术后最初的2-3天在重症监护病房度过,在此能够对心脏功能进行密切监控。平均住院时间在1至2周之间,另外还需要几周至数月时间以彻底恢复。
最近几年,微创手术和介入心脏病学的发展鼓励一些研究人员进行经皮主动脉心脏瓣膜替换。参见例如美国专利No.6,168,614。在很多此类手术中,替换的瓣膜被穿过自体病变瓣膜展开以永久地保持瓣膜打开,从而缓解切除自体瓣膜并将替换瓣膜安置在自体瓣膜所处位置的需要。
在血管内主动脉瓣替换手术中,主动脉瓣相对于冠状动脉口和二尖瓣的精确放置是关键所在。但是,由标准自动伸缩支架系统构成的瓣膜锚定件被认为在展开时具有很差的精度。在通常的展开过程中,直到通过透视确定精确放置后,支架的近端才会从输送系统中被释放出来。支架一旦被释放即可跳跃至另一位置,使得无法获知支架末端在被释放后相对于自体瓣膜、冠状动脉口和二尖瓣所处的位置。
在最终展开之前对新瓣膜工作方式的可视化也是很需要的。由于一些自动伸缩锚定件预期的跳跃动作,以及由于替换瓣膜在最终展开之前可能不是完全功能的,因此瓣膜功能和位置的可视化在最终且不可逆展开之前可能无法在这些系统中实现。
现有技术中自动伸缩替换心脏瓣膜系统的另一个可能的缺点是其相对缺乏径向强度。为了使自动伸缩系统能够通过输送护套被很容易地输送,金属需要在输送导管内伸缩和弯曲而不发生塑性变形。适用于针对其他目的的血管内输送的可伸缩支架设计可能不具有用作替换心脏瓣膜锚定件的足够的径向强度。例如,有多种商用动脉支架系统可以向动脉壁施加足够的径向力以治疗动脉粥样硬化并能够塌缩为足够小的直径以装入输送导管中而不发生塑性变形。但是,当支架具有固定在其中的瓣膜,且该瓣膜必须驻留在心脏内时,正如在主动脉瓣替换的情况下,支架到血管壁的锚定需要大得多的径向力,特别是在心脏舒张期间。在心脏舒张期间抑制动脉压并防止血液回流到心室内的作用力将被直接传送至支架/血管壁的接合部。因此,需要用于保持自动伸缩支架/瓣膜和血管壁相接触且不滑动的径向作用力的大小将远远大于其内部没有瓣膜的支架。而且,不具有足够径向力的自动伸缩支架最终将随着每一次心跳而扩张和收缩,从而使瓣膜扭曲,影响其功能并可能导致其移动和完全移出。简单地增加自动伸缩支架的支杆厚度不是一种好的解决方案,因为这会增大外型尺寸和/或增加自动伸缩支架塑性变形的危险。
由于上述用于血管内替换心脏瓣膜的现有技术的相关缺点,因此希望提供能够克服这些缺点的方法和装置。
发明内容
本发明的一个方面是适用于通过体腔输送医疗植入物和在体内某一位置处释放医疗植入物的输送系统。该输送系统包括多个第一可致动元件,其适用于以第一结构接合多个第二元件来捕获输送系统内的植入物,且其中多个第一可致动元件适用于以第二结构接合多个第二元件并从输送系统中释放植入物。
在一些实施方式中,多个第一可致动元件适用于以第一结构接合多个第二元件从而形成一个空间,医疗植入物通过输送系统在该空间内被捕获。
在一些实施方式中,多个第一可致动元件和多个第二元件适用于通过致动多个第一可致动元件以从多个第二元件释放植入物。
在一些实施方式中,多个第一可致动元件和多个第二元件适用于以第一结构接合并锁定。
在一些实施方式中,多个第一可致动元件适用于通过可以从体外被引入的指向近侧的力被致动。
在一些实施方式中,多个可致动元件是刚性元件,而在一些实施方式中医疗植入物是可扩张锚定件。
在一些实施方式中,该系统还包括适用于限制输送系统扩张的约束机构。
在一些实施方式中,多个第一可致动元件和多个第二元件都不适用于被联接至第一位置处的植入物。
在一些实施方式中,医疗植入物包括可扩张编织物。
本发明的一个方面是适用于在输送系统内可释放地捕获医疗植入物的捕获系统,其中输送系统适用于通过体腔输送医疗植入物。联接系统包括多个指状元件和多个可致动元件,每个可致动元件均被设置为与多个指状元件中的一个可滑动地相接。多个可致动元件中的每一个都适用于在第一位置接合多个指状元件中的一个,以捕获至少一部分医疗植入物,且多个可致动元件中的每一个都适用于在第二位置接合多个指状元件中的一个,以从联接系统中释放所述一部分医疗植入物。
在一些实施方式中,多个指状元件和多个可致动元件适用于接合并锁定在一起。多个指状元件和多个可致动元件能够适用于在第一位置接合并锁定和可选地在第二位置接合并锁定。
在一些实施方式中,多个可致动元件适用于通过指向近侧的力被致动。可致动元件能够适用于被致动以从多个指状元件解锁。可致动元件可以包括适用于与指状元件相接合以将其锁定在一起的锁定元件,可致动元件还包括适用于在可致动元件从第一位置解锁后防止锁定元件运动的锁止元件。锁定元件和锁止元件可以被成形为互相匹配。多个可致动元件适用于通过致动而运动,例如通过在第二元件上滑动,而从解锁位置到达第二位置。
在一些实施方式中,多个可致动元件适用于通过释放作用在多个可致动元件上的致动力,例如指向近侧的致动力,而被锁定在第二位置。
在一些实施方式中,该系统还包括多个释放致动器,其可以包括释放致动器组,其中多个可致动元件适用于通过多个释放致动器而被致动。
在一些实施方式中,多个指状元件包括植入物接口,植入物接口可以被设置在多个指状元件的远端附近,并且可以包括适用于接收植入物的空腔。
在一些实施方式中,多个可致动元件和多个指状元件都不适用于被联接至植入物。
在一些实施方式中,在可致动元件被从第一位置向第二位置移动时植入物从联接系统中被释放。可致动元件可以包括弹出元件,弹出元件可以大致位于可致动元件的远端,适用于在可致动元件从第一位置运动到第二位置时从指状元件中弹出植入物,从而从捕获系统中释放植入物。
在一些实施方式中,多个指状元件包括适用于限制捕获系统扩张的约束装置。约束装置可以穿过多个指状元件内的一组孔中的每一个孔,从而联接多个指状元件并限制多个指状元件的扩张。
在一些实施方式中,医疗植入物包括可扩张的编织物。
本发明的一个方面是一种在患者的心脏瓣膜附近在血管内输送和释放医疗植入物的方法。该方法包括用输送系统在输送结构内将医疗植入物在血管内输送至心脏瓣膜附近或心脏瓣膜内的位置,防止植入物从输送系统中被释放,其中输送系统包括以第一结构接合多个指状元件的多个第一可致动元件,并致动多个第一可致动元件以使多个第一可致动元件以第二结构接合多个指状元件,从而从输送系统中释放植入物。
在一些实施方式中,医疗植入物的输送包括将输送系统从输送结构扩张成为扩张结构。在一些实施方式中,膨胀被约束装置所限制。
在一些实施方式中,防止植入物被释放包括在指状元件和可致动元件之间的空间内捕获至少一部分医疗植入物。
在一些实施方式中,致动多个第一可致动元件包括从多个指状元件上解锁多个可致动元件。解锁可以包括在多个可致动元件上施加指向近侧的力。
在一些实施方式中,致动多个第一可致动元件包括在指状元件的外表面上滑动多个可致动元件。滑动可以包括向多个可致动元件施加指向近侧的力。
在一些实施方式中,从输送系统中释放医疗植入物包括从输送系统中弹出植入物。弹出可以包括在多个可致动元件从第一结构向第二结构运动时从输送系统中弹出植入物。弹出可以包括使可致动元件的远端与至少一部分医疗植入物相接合,以从指状元件中释放医疗植入物。
在一些实施方式中,该方法还包括释放施加至多个可致动元件上的指向近侧的力,其中释放指向近侧的力将多个可致动元件与多个指状元件重新锁定。
附图说明
图1A和图1B示出了根据本发明的替换瓣膜设备。图1A示出了在输送系统内处于收缩输送结构下的该设备。图1B示出了处于从输送系统中部分展开的扩张结构下的该设备。
图2A-2F示出了图1中处于收缩输送结构和扩张展开结构下的该设备的锚定件,以及展开结构下的整个设备,和用于该设备中的可选锁定机构。
图3A-3E示出了使用替换的心脏瓣膜和锚定件来替换主动脉瓣。
图4A和图4B示出了处于开启结构下的锚定锁的一种替代实施方式。
图5A和图5B示出了图4中的处于锁定结构下的锚定锁。
图6示出了一种用于本发明中的替代的锚定件展开工具的连接和释放机构。
图7示出了图6中处于被释放过程中的连接和释放机构。
图8示出了图6和图7中的处于已释放状态下的连接和释放机构。
图9示出了一种处于未展开结构下的根据本发明的替换心脏瓣膜和锚定件以及展开工具的替代实施方式。
图10示出了图9中的处于部分展开结构下的替换心脏瓣膜和锚定件。
图11示出了图9和图10中的处于更充分展开结构下但仍连接有展开工具的替换心脏瓣膜和锚定件。
图12又示出了本发明的使用替换心脏瓣膜和锚定件的输送和展开设备的另一种替代实施方式。
图13示出了图12的在展开替换心脏瓣膜和锚定件过程中的输送和展开设备。
图14示出了锚柱的一种变形的细部视图。
图15A和图15B示出了一种具有锁定对准部件的锚柱的替代变形。
图16A和图16B示出了一种具有替代的锁定对准部件的锚柱的变形。
图17示出了一种具有可扩张元件的锚柱的变形。
图18示出了一种具有替代的可扩张元件的锚柱的变形。
图19A-19C示出了一种具有替代的锁定对准部件的锚柱的变形。
图20示出了与图示的致动器和释放致动器相接合的图14中的锚柱的变形。
图21A-21C示出了构成一种替代的可释放连接机构的锚柱、致动器和释放致动器的一种变形。
图22A-22C示出了可释放连接机构的另一种变形。
图23A-23C又示出了可释放连接机构的另一种变形。
图24A和图24B仍示出了可释放连接元件的另一种变形。
图25示出了锚柱、致动器和具有双向锁的锚定件锁定元件的一种变形。
图26A-26C示出了致动器、锁定致动器和释放致动器的一种变形。
图27示出了具有锁定对准部件的锚定件锁定元件的一种变形。
图28A和图28B示出了图27中设备的可释放连接机构的扩张、锁定和致动。
图29示出了具有可致动防止锁定机构的设备的另一种变形。
图30A和图30B示出了被设置为锁住锚定件编织物的锚柱的一种变形。
图31A-31C示出了锚定件锁定元件的一种变形的致动和释放。
图32A和图32B示出了具有能够从管中被切除的锁定对准机构的可释放致动机构的另一种变形。
图33A-33D示出了可以由截断管材制成的锚定件锁定元件的一种变形的致动。
图34A-34F示出了具有解锁致动器的锚柱的一种变形。
图35A和图35B示出了锚定件锁定元件的另一种带扣变形。
图36示出了锚定件锁定元件的变形和锚定件的连接。
图37示出了锚柱和具有棘轮锁的锚定件锁定元件的一种变形。
图38A和图38B示出了棘轮锁的变形。
图39A-39H示出了棘轮锁的另一种变形的致动。
图40A-40C示出了棘轮锁定元件的一种管状变形。
图41A-41C示出了图40中锚定件锁定元件的一种变形。
图42A和图42B示出了图41中包括锁定对准部件的设备的一种变形。
图43A-43F示出了一种致动和调节图41中设备的棘轮锁的方法。
图44A和图44B示出了锚定件/致动器的一种变形。
图45A-45C示出了图44中致动器的可释放连接机构的细部视图。
图46A-46C示出了图45中可释放连接机构的一种变形。
图47A-47C示出了可释放连接机构的另一种变形。
图48A-48C又示出了可释放连接机构的另一种变形。
图49A-49N示出了与图45中的可释放连接机构共同使用的释放致动器的变形。
图50A和图50B示出了输送系统/展开工具的一种实施方式的细部视图。
图51A和图51B示出了图50中的可释放地连接至设备10,和从设备分离的输送系统/展开工具。
图52A和图52B示出了图50和图51中的输送系统/展开工具的一种变形,其中致动器从一个整体结构延伸。
图53A-53C示出了将元件连接至替换瓣膜设备的锚定件的各种方式。
图54示出了捕获示例性医疗植入物的输送系统的示例性远端。
图55示出了示例性指状元件。
图56和图57示出了指状元件的一部分的两种实施方式。
图58是示出了具有限制输送系统扩张的约束装置的示例性捕获系统的侧视图。
图59是示出了已扩张的捕获系统的端视图。
图60是示出了示例性约束装置的端视图。
图61示出了本发明的示例性可致动元件。
图62是本发明的示例性可致动元件的透视图。
图63是具有在系统内捕获的示例性医疗植入物的第一结构下的示例性捕获系统的侧视图。
图64示出了从第二元件解锁的可致动元件。
图65示出了从输送系统中释放的一部分医疗植入物。
图66和图67示出了相对于第二元件处于第二锁定位置的可致动元件。
图68是可致动元件的一种替代实施方式。
图69示出了捕获系统的一部分的一种替代结构。
图70和图71示出了一种替代实施方式,其中第一可致动元件的一部分被改装为连续弹簧元件。
图72示出了释放致动器的一种替代实施方式。
图73示出了图72中释放致动器的远端。
图74示出了已解锁并处于第一和第二位置之间的第一可致动元件。
图75示出了锁定在第二位置的第一可致动元件。
图76示出了示例性释放致动器组的端视图。
图77示出了释放致动器组和释放致动器组工具。
图78示出了多个释放致动器组。
图79示出了处于层叠位置的多个释放致动器组。
具体实施方式
本发明涉及用于在患者自体心脏瓣膜内和/或穿过患者自体心脏瓣膜在血管内输送和展开假体例如主动脉假体的设备和方法,在下文中提及时均称作替换患者的心脏瓣膜。提供一种输送系统和/或展开工具,其包括用于在患者体内血管内放置假体设备的护套组件和导丝并允许使用者控制从患者体外通过在锚定件上施加的非液压扩张力或非气动扩张力来调节假体设备。液压或气动扩张力可以是例如通过在锚定件内扩张的球囊施加在锚定件上的力。在某些实施方式中,非液压扩张或非气动扩张力的施加可以包括使用液压部件在锚定件上传输向近侧或向远侧的导向力。
该设备包括锚定件和替换瓣膜。锚定件包括可扩张的锚定件例如编织物。在优选的实施方式中,可扩张编织物包括封闭的边缘,但是边缘可选地可以被打开。替换瓣膜适用于被固定在锚定件内,并这样被在血管内输送至患者的心脏以替换患者的自体心脏瓣膜。更优选地,本发明的设备和方法也可以用于患者主动脉瓣的替换。
图1A和图1B示出了根据本发明的输送系统/展开工具和设备的一种实施方式。如图1A所示,设备10可以被收缩,用于输送系统/展开工具100内的输送。输送系统100包括导丝G、鼻锥102、锚定件致动元件106、具有可选的中心腔109和多个周向分布腔Lu的多腔杆或导管108、具有可选的近侧手柄111的外护套110,和控制手柄120。鼻锥102例如可以通过穿过多腔导管108的中心腔109延伸的杆而被控制。
锚定件致动元件106优选地包括近侧锚定件致动元件和远侧锚定件致动元件。近侧锚定件致动元件可以包括例如通过可释放连接机构可释放地连接至设备10的锚定件30的近侧区域的致动器106a用于控制设备10的近侧区域。远侧锚定件致动元件可以包括通过可释放连接机构可释放地连接至锚定件30的远侧区域的致动器106b用于控制设备10的远侧区域。在一些实施方式中,远侧锚定件致动元件可以包括锚定件30的锚柱或锚定件连接元件32和将致动器106b连接至锚柱32的可释放连接机构。在一种替代的结构中,近侧锚定件致动元件可以通过锚柱和可释放连接机构被可释放地连接至设备10的近侧区域,用于控制设备的近侧区域,而远侧锚定件致动元件可以通过可释放连接机构连接至锚定件30的远侧区域,以控制设备的远侧区域。作为另一种可选结构,近侧和远侧锚定件致动元件都可以通过可释放连接机构连接至锚定件30。
在图1所示的实施方式中,致动器106a例如可以包括从多腔杆108的远侧区域延伸的刚性指状元件,而致动器106b可以包括穿过杆108的一个或多个腔Lu的控制丝(例如缝合线架,或金属丝或高分子丝)。用于两组致动器的可释放连接机构的释放致动器112也可以穿过杆108的一个或多个腔Lu。释放致动器可以包括例如控制丝(例如缝合线架,或金属丝或高分子丝)、封盖、芯轴、细长元件、摩擦表面、包裹部分、干扰形状等。释放致动器优选地可以例如通过控制手柄120相对于锚定件致动元件106a移动。
控制手柄120被连接至多腔杆108。位于槽123内的滑块122可以致动将锚定件致动元件106的致动器106a连接至设备10的释放致动器112。同样地,位于槽125内的滑块124可以致动将锚定件致动元件106的致动器106b连接至设备10的锚定件30的锚柱32的释放致动器112。手柄120还包括旋钮126,用于例如调节致动器106b以控制设备10的远侧区域相对于其近侧区域运动。反之,设备10的近侧区域相对于其远侧区域的控制动作可以通过保持旋钮126静止同时推进或收回手柄120而实现。旋钮126可选地可以一致地移动致动器106b和与之相连的释放致动器112。
设备10包括锚定件30和替换瓣膜20。锚定件30优选地包括编织物。这种编织物可以在其一端或者两端都具有封闭端。替换瓣膜20优选地沿锚柱32,例如沿瓣膜连接机构例如接头和/或多个孔被联接至锚定件。因此锚柱32可以用作瓣膜支撑部件并可以适用于在锚定件内支撑替换瓣膜。在图示的实施方式中有三个锚柱,对应于瓣膜的三个联接连接点。锚柱可以被连接至锚定件30的编织物部分。锚柱可以被连接至编织物的远端,如图2A所示,中心区域,或近端。替换瓣膜20可以由合成材料构成和/或从动物组织中提取。替换瓣膜20优选地被设置为固定在锚定件30内。
锚定件30包括连接在其近侧区域的多个锚定件锁定元件34,例如带扣34,每个带扣34与每个锚柱32一一对应。锚柱32可以包括锁定元件以和锚定件锁定元件34一起形成两段式锁定机构,用于将锚定件30保持为展开或扩张结构(例如,如图1B、2B和2C中所示)。
在本实施方式中,锚定件30由可收缩且可扩张的金属丝编织物制成。锚定件编织物30优选地为自动伸缩式且优选地通过使用一股或多股例如镍钛诺、钴铬钢或不锈钢材料的金属丝制成。编织锚定件30的输送和展开与申请号为10/746,120的美国专利申请中介绍的锚定件的输送和展开相类似。具体地,在下面介绍的一种实施方式中,在展开期间,编织锚定件30通过相对于致动器106a向近侧收回致动器106b而被主动地预先缩短以使锚定件扩张并锁定就位。在一些实施方式中,预先缩短可以使锚定件30扩张为径向对称、两边对称,或不对称扩张的形状。预先缩短的步骤可以包括将锚定件的第一区域扩张至第一直径以及将锚定件的第二区域扩张至大于第一直径的第二直径。第三区域也可以被扩张至大于第一直径的直径。锚定件的不同区域(例如远侧区域)的扩张对于定位主动脉瓣和在锚定件内将其定中心是特别有用的。优选地,固定的锚定件不会影响二尖瓣或心门。在一些实施方式中,锚定件被允许在预先缩短步骤之前自扩张。
如图1所示,在通过护套110在血管内输送至患者自体瓣膜(例如主动脉瓣)附近之后,设备10可以利用输送系统/展开工具100从图1A中的收缩输送结构扩张为图1B中的扩张展开结构。为了展开设备10,可以通过相对于控制手柄120向近侧收回护套手柄111而相对于设备10收回外护套110。护套110因此被从设备10的外部移除,允许锚定件30自动伸缩。例如,如果锚定件编织物30由形状记忆材料制成,那么它可以自动伸缩为其“静止”结构或者向“静止”结构自动伸缩。编织物的这种静止结构可以是例如其扩张结构、收缩结构或者在收缩结构和扩张结构之间的部分扩张结构。在优选的实施方式中,锚定件的静止结构处于收缩结构和扩张结构之间。根据编织物的静止直径和在选定展开位置的患者解剖直径,锚定件可以自动伸缩也可以不自动伸缩为在该位置与患者解剖直径相接触。
在其收缩结构下,锚定件30优选地具有大约3至30Fr,或者更优选地为6至28Fr,或者更优选地为12至24Fr的收缩输送直径。在一些实施方式中,锚定件30在其收缩结构下将具有从大约5mm至大约170mm,更优选地从大约10mm到大约160mm,更优选地从大约15mm到大约150mm,更优选地从大约20mm到大约140mm,或者更优选地从大约25mm到大约130mm的长度范围。
类似地,在其扩张结构下,锚定件30优选地具有大约10至大约36mm,或者更优选地为大约24至大约33mm,或者更优选地为大约24至大约30mm的直径范围。在一些实施方式中,锚定件30在其扩张结构下将具有从大约1mm至大约50mm,更优选地从大约2mm到大约40mm,更优选地从大约5mm到大约30mm,或者更优选地从大约7mm到大约20mm的长度范围。
总之,展开和收缩/护套长度之比优选地在大约0.05至0.5之间,更优选地在大约0.1至0.35之间,或者更优选地在大约0.15至0.25之间。在本文的所有实施方式中,锚定件30在其膨胀结构下优选地具有径向抗压强度,以保持锚定件响应于基本上径向向内朝向中心轴线的高达大约0.5atm的压力,或者更优选地基本上径向向内朝向中心轴线的高达大约2atm的压力而基本不变形。
另外,在本文的所有实施方式中,锚定件优选地具有大约在10至250g/cm之间,更优选地在大约20至200g/cm之间,或者更优选地在大约40至160g/cm之间的轴向弹性常数。另外,在本文的所有实施方式中,锚定件优选地适于在锚定部位响应于高达大约120mmHg,更优选地高达大约240mmHg,或者更优选地高达大约320mmHg的压差而支撑替换瓣膜。
这些参数不应理解为限制性的。落入本发明保护范围之内的其他参数对于本领域普通技术人员来说是显而易见的。
如图1B所示,锚定件30可以通过在血管内展开期间主动地预先缩短锚定件30而从部分展开结构(例如自动伸缩结构)扩张为完全展开结构。在一些实施方式中,设备的预先缩短包括通过一个或多个锚定件致动元件在锚定件的近端施加指向远侧的力来向远侧运动锚定件的近端同时保持锚定件远端的位置。例如,锚定件30的近侧区域可以通过某些锚定件致动元件106例如致动器106a而被向远侧推动。替代地,设备的预先缩短包括通过一个或多个锚定件致动元件在锚定件的远端施加指向近侧的力来向近侧运动锚定件的远端同时保持锚定件近端的位置。例如,锚定件30的远侧区域可以通过由锚柱致动元件106b施加的指向近侧的力而被向近侧推动,该力与锚定件致动器106a所施加的力相反。
锚定件致动元件106优选地适于随着锚定件的径向扩张而径向扩张和随着锚定件的径向收缩而径向收缩。而且,由锚定件致动元件在锚定件一端施加的指向近侧或远侧的力并不沿直径约束锚定件的相对端。另外,当指向近侧或远侧的力通过锚定件致动元件被施加至锚定件时,其优选地无需经过展开系统的任何部分而通过替换瓣膜的中心开口施加。这种设置能够在展开期间和移除展开系统之前使替换瓣膜工作。
远侧锚定件致动元件可以包括例如致动器106b和/或通过控制手柄120的控制滑块124和旋钮126控制的释放致动器112。类似地,锚定件30的近侧区域可以通过在锚定件近侧区域的近侧锚定件致动元件例如致动器106a被从远侧推进。近侧锚定件致动元件有助于向锚定件30的近端施加指向远侧的力,以从远侧运动或约束锚定件的近端并通过杆108相对于远侧锚定件致动元件的动作而被控制。控制手柄120的控制滑块122可以控制释放致动器112,以从编织物释放近侧锚定件致动元件。近侧锚定件致动元件可以进一步适于在向锚定件的近端施加指向远侧的力期间随着锚定件近端的径向扩张而扩张。优选地,为了使锚定件30的编织物扩张,近侧锚定件致动元件通过多个致动器106a向锚定件系统的近端施加指向远侧的力。这种编织物扩张可选地可以借助如申请号为10/746,120的美国专利申请中介绍的可翻转地位于设备10内的球囊导管(参见图12和图13)的膨胀进行。
在完全展开结构中,锚柱32的锁定元件和锚定件30的锚定件锁定元件或带扣34可以被用于将锚定件锁定并保持为展开结构。直到锚柱32的锁定元件和锚定件30的锚定件锁定元件34被互锁以形成锁40之前,设备10都可以被重新定位或从患者体内收回。在一个实施方式中,致动器106b和附带的释放致动器112包括连接至锚柱32并被穿过带扣34的控制丝,使得在展开期间通过控制丝施加在锚柱32上的指向近侧的力向带扣34拉动锚柱32的锁定元件并通过带扣34以形成锁40。用这种方式,控制丝可以用作锚定件致动器和锁定致动器。
这种锁可选地可以是选择性地可逆的,以允许在展开期间或展开后重新定位和/或收回设备10。当锁选择性地可逆时,设备可以根据需要被重新定位和/或收回,也就是说,即使在锁40的致动之后亦可。
本文中所用的锁也可以包括多个锁定级别,其中每一个锁定级别导致一种不同程度的扩张。例如,锚柱近端处的锚定件锁定元件可以具有用于在带扣内锁定的多种结构,其中每一种结构导致一种不同程度的锚定件扩张(参见例如图2F)。这种锁定结构可以例如包括具有多个锁定位置的棘轮。而且,可以提供锁定对准部件,以便于使锚柱和锚定件锁定元件对准,例如折叶或大宽度的锚柱或锚定件锁定元件。而且,还可以提供防锁定机构,以阻止锁定直至专业医务人员需要锁定时为止。
当设备10被穿过患者的病变心脏瓣膜放置时,锚定件30可以被用于替换患者的自体瓣叶,而替换瓣膜20将随后替代自体瓣膜工作。在最终定位和扩张后,设备10可以通过借助可释放连接机构从设备分离近侧和远侧锚定件致动元件106,例如通过借助可释放的连接机构从编织锚定件30分离近侧致动器106a和从锚定件的锚柱32分离远侧致动器106b,而被从输送系统100分离。例如使用手柄120的滑块122和124来运动释放致动器112,可以例如致动可释放连接机构。优选地,可释放连接机构可以通过使一个或多个释放致动器运动小于大约1英寸来致动。在分离后,输送系统/展开工具100可以从患者身上移除,从而完成患者心脏瓣膜的血管内替换。
在植入本文中介绍的替换瓣膜设备之前,可能需要通过将球囊插入到瓣膜中并使用例如混有造影剂的盐水使其扩张而在患者病变的瓣膜上进行瓣膜成形术。除了准备用于植入的瓣膜部位之外,瓣膜成形术的荧光透视将有助于确定要使用的替换瓣膜植入物的适当尺寸。
图2A-2C示出了设备10的锚定件30的更多细节。图2A示出了处于收缩结构的设备,例如用于在护套或其他管腔内输送或者用于收回或者重新捕获回护套或其他管腔内。图2B和图2C示出了膨胀和锁定结构下的锚定件和瓣膜。
如图2B所示,锚定件30示范性地具有三个锚柱和三个带扣。如图2C所示,替换瓣膜20的三个瓣叶可以沿瓣膜支撑结构被连接至三个锚柱32。这样,锚柱32起到瓣膜支撑部件的作用。锚柱,与编织物不同,并不收缩或扩张。在一些实施方式中,锚柱32具有一个或多个近侧槽33,至少一个近侧孔36a和至少一个远侧孔36b。瓣叶组织可以例如被穿过槽33并用缝合线穿过一个或多个近侧孔36a而在此被缝合。用这种方式,一个或多个槽33和一个或多个孔36a可以构成瓣膜支撑结构。也可以使用现有技术中可选的用于将瓣叶固定至锚柱的瓣膜支撑结构。
锚柱32可以经由一个或多个远侧孔36b被联接至锚定件编织物30。例如,锚定件编织物30可以通过孔36b进行编织,或者缝合线或丝可以被穿过孔36b并系至编织物。然而锚柱32内的另一个近侧孔(未示出)用作锚定件锁定元件,该锁定元件与由带扣34提供的锚定件锁定元件相接合以形成锁40。带扣34可以类似地经由编织或缝合被连接至锚定件编织物30。
替代的锁可以被用于以例如图2D-2F中所示的预先缩短的结构锁定本发明中的锚定件。优选地,本发明中的锁可以具有多个锁定位置,使得锁定能够实现多种程度的扩张。而且,锁定位置可以被不对称地使用以使得锚定件实现非圆柱形的形状。在图2D中,锁40′包括位于锚柱32上的凸形锁定元件44和位于编织锚定件30上的锚定件锁定元件34。锚定件锁定元件34示范性地包括三角形突起或锚定件30的锁孔42。凹形锁定元件42的三角形形状可以便于用凹形锁定元件匹配凸形锁定元件44而不会使凸形锁定元件受迫变形。一个或多个孔45可以被穿过锚柱32设置,例如用于可释放地将致动器106b连接至锚柱。
在图2E中,锁40″包括沿锚柱32具有多个管内箭头46的凸形锁定元件44′。每个箭头都包括可弹性变形的附加件48,以便于穿过示范性地由圆形锁孔构成的凹形锁定元件42′。附加件48可选地包括孔49,以使得可释放的防锁定机构47,示范性地为一条控制丝,可以穿过该孔以将附加件约束在变形结构下。为了致动锁40″,凸形锁定元件44′的一个或多个箭头46例如通过锚柱/锁定致动器被拉过凹形锁定元件42′,然后将防锁定机构从孔49移除,从而使附加件48弹性扩张并致动锁40″。
有利地,沿锚柱32设置的多个箭头46形成棘轮以便于在体内确定加在锚定件30上的预先缩短和扩张的程度。而且,即使在凸形元件44′已经被推进穿过凹形部件42′之后,可选地箭头46的约束附加件48也可以通过机构47防止锁40″的致动(和因此设备10的展开)。只有在专业医务人员移除约束附加件48的防锁定机构47之后,锁40″才能被完全接合并被不可逆的展开。
除了附加件48上的孔49被去除,和防锁定机构包括套管或外壳47之外,图2F中的锁40”’与图2E中的锁40″类似。套管47约束附加件48以防止锁定,直到专业医务人员确定本发明的设备已被预先缩短和在治疗部位适当定位为止。锁40”’可以例如通过向致动器106b施加指向近侧的力而被致动。致动器106b示范性地包括穿过锚柱32内的孔45可释放地设置的控制丝。这样防锁定机构47可以相对于锚定件30被从近侧抽出,驱使附加件弹性扩张,从而完全致动锁40”’。
下面结合图1和图2参照图3,介绍一种用设备10和输送系统/展开工具100在血管内替换患者病变的主动脉瓣的方法。如图3A所示,具有设置在其中的设备10的输送系统100的护套110,被优选地以逆行方式(但也可以使用顺行方式或交替地混合方式)在导丝G上方血管内推进,穿过患者的主动脉A到达患者病变的主动脉瓣AV。鼻锥102以公知的方式伸出护套110。在图3B中,护套110被定位成使得其远侧区域位于患者心脏H的左心室LV内。
设备10例如在通过相对于杆108向近侧收回护套110的近侧手柄111的荧光指引下被从护套110的腔Lu展开,以使得设备10的锚定件30动态地自扩张为图3C中的部分展开结构。有利地,设备10可以通过相对于护套收回杆108从而相对于护套110收回联接至锚定件30的致动器106a而被收回到护套110的腔Lu内。用这种方式,即使在锚定件已经动态扩张至部分展开结构之后,锚定件30可以被收回,例如用于取消手术或者重新定位设备10或输送系统100。而另一个优点是,为了适当地相对于解剖标记例如患者的冠状动脉口或患者的自体瓣叶L对准设备,设备10可以被动态地重新定位。在适当地对准时,锚定件30的远侧区域优选地被设置在瓣叶的远侧,同时锚定件的中心区域被设置为穿过瓣叶而近侧区域被设置在瓣叶的近侧。
一旦适当地对准,致动器106b例如通过手柄120的旋钮126被从近侧相对于致动器106a收回,以在锚定件30上进行预先缩短并进一步将设备10扩张为完全展开结构,如图3D所示。预先缩短增加了锚定件30的径向强度,以确保瓣环An的长期通畅,以及给设备10提供了更好的密封以减少瓣周返流。通过将锚柱32的锚柱锁定元件44和锚定件30的锚定件锁定元件34接合而构成的锁40保持已完成的预先缩短。替换瓣膜20被适当地放入锚定件30内,左心室LV和主动脉A之间的正常血流随后被完全通过设备10控制,尽管瓣膜20在展开期间也是有效的。设备10的展开有利地是完全可逆的,直到锁被致动为止。可以提供可释放的防锁定机构以确保锁不会被过早致动。而且,锁也可以是可逆的,以使得即使在锁致动以后设备10也可以被收回或重新定位。
一旦设备10完全扩张并锁定在扩张结构下,致动器106a就通过致动可释放连接机构,例如通过用手柄120的滑块122相对于致动器106a收回释放致动器112而被从锚定件30分离。同样,致动器106b通过致动可释放连接机构,例如通过用手柄120的滑块124相对于致动器106b收回释放致动器112而被从锚柱32分离。如图3E所示,随后可以从患者体内移除输送系统100,从而完成设备10的完全展开。可选的倒钩元件37与患者的自体瓣叶接合,例如用于排除设备移动和/或减少瓣周返流。
图4和图5示出了锚定件锁定机构,其中图4中所示的锚定件锁定机构处于锁定结构。图4和图5应该被视为圆柱形锚定件30已被切开并平放。联接至锚定件30的锚柱32示范性地包括致动器连接元件200和锁定元件202,例如锁孔或穿过锚柱形成的孔。锚定件30包括锚定件锁定元件34,示范性的带扣,带扣被设置为和锚柱的锁定元件202相匹配。锚柱32和带扣34可以例如通过将锚柱和带扣交织在锚定件的编织物内而被连接至编织锚定件30。替代地,锚柱和/或带扣可以被缝合、软焊、焊接、用粘合剂等连接至锚定件。前述替换瓣膜20的联接处可以沿其整个或部分长度被连接至锚柱32。
锚柱32的锁定元件202与伸入锚定件锁定元件34的孔212内的锁片210相配合。要锁定时,可释放地穿过锚柱32的致动器连接元件200和锚定件锁定元件34的孔212的致动器106b,被从近侧通过锚定件致动器106b(示范性地为控制丝)向编织锚定件30的近端拉动以将锚柱32拉过孔212,从而使锁片210接合锚柱32的锁定元件202。还示出了解锁致动器220,示范性地为控制丝,控制丝穿过锚定件锁定元件34内的锚定件锁孔214。如果需要,在手术期间,使用者可以拉动解锁致动器220,从而逆转锁片210的朝向,释放锚定件并允许重新定位装置或从患者体内将其移除。只有在实现手术医生所需的最终定位之后,才能将解锁致动器220以及致动器106b从设备10和患者体内移除。
下面参照图6-8,介绍一种释放锚定件(或锚柱等)和锚定件致动元件之间的连接的替代方法。在图6中,释放致动器112,示范性地为控制丝,从患者体外穿过致动器106a延伸,交叉穿过编织锚定件30的近侧区域并部分延伸返回致动器106a内。释放致动器112的叠加部分在致动器106a内形成作用力以在致动器106a内的所有释放致动器112被从近侧拉动时,例如在锚定件30上施加指向近侧的力时,保持释放致动器相对于致动器106a的位置。但是,当单个的释放致动器112被从近侧拉动时,释放致动器和其所在的致动器106a之间的摩擦力被克服,使得释放致动器112的末端113脱离致动器106a,如图7和图8所示,从而释放锚定件30。在一种替代的实施方式中,释放致动器112的叠加部分可以向近侧延伸至例如控制手柄120。在这样的实施方式中,锚定件30的扩张可以通过用控制手柄向近侧收回叠加的释放致动器112的末端而实现,而致动器106a的释放可以通过拉动释放致动器112的一端而实现。
图9-11示出了设备10的其他视图。锚定件30由金属编织物,例如镍钛诺或不锈钢制成。替换瓣膜20被设置在锚定件30内。锚定件30用与前述基本相同的方式通过从远侧锚定件致动器(未示出)和致动器106a施加指向近侧和远侧的力而被致动。
图12和图13示出了本发明的输送和展开设备的另一种实施方式。在本实施方式中,鼻锥(例如图1A和3中的元件102)被用血管成形球囊导管230替代。这样,血管成形球囊导管230先于护套110接触导丝G。当锚定件30和瓣膜20如上所述通过锚定件致动元件106的操作而扩张时,球囊导管230在扩张的锚定件和瓣膜内被向近侧收回并且如果需要还可以被充气以进一步使设备10扩张。可选地,单独的球囊导管或瓣膜成型导管可以在扩张之后被提前放入设备10内以实现设备的附加扩张。
下面参照图14,介绍锚柱32的一种变形的细部视图。在图14中,锚柱32示范性地包括用于将锚柱连接至致动器106b的致动器连接元件250;示范性地为槽的锚柱锁定元件252,用于和锚定件锁定元件34一起互锁锚柱32;瓣膜连接结构254,包括槽255和多个孔256,用于将替换瓣膜20连接至锚柱(瓣膜的锁片可以被穿过槽255,然后通过孔256被缝至锚柱背部);和用于将锚柱连接至锚定件30的远侧区域的编织物连接元件258。锚定件30的编织物可以例如通过编织物连接元件258被交织在一起。锚柱32可以由多种材料制成,例如金属材料譬如不锈钢,而且可以是通过激光切割,压铸等方法加工而成。在锚柱32的这种变形中,瓣膜20被设置在锁定元件252的远侧。在可选的其他变形中,瓣膜也可以被连接至锁定元件的锚柱近侧或者在管内与锁定元件相连(也就是说,既不是近侧锁定也不是远侧锁定)。
图15提供了一种锚柱32的可选变形。在图15中,锚柱32包括具有锁定对准部件262的锁定元件260,示范性地为折叶263。折叶263允许锁定元件260从如图15A中所示的与锚柱32共线的位置旋转至如图15B所示的与锚柱不对齐的位置,从而便于和锚定件锁定元件34对准。如图所示,锚柱32还包括致动器连接元件264,示范性地为锁孔,具有槽267和多个孔268的瓣膜支撑结构266,以及编织物连接元件269。
图16示出了一种包括弹簧270的锁定对准部件262的替代变形。由于带有折叶263,弹簧270有助于通过允许锚柱锁定元件从如图16A所示的与锚柱32共线的位置旋转至如图16B所示的与锚柱不对齐的位置而使锚柱锁定元件260和锚定件锁定元件34对准。弹簧270也施加促使锚柱锁定元件260恢复与锚柱32对齐的回复力。而且,弹簧270也有助于锚柱32响应轴向拉力而动态延长。这种延长可能有助于锚定件30响应施加至锚定件的径向向内的压力而轴向拉长。
参照图17,提供了锚柱32的另一种变形,该锚柱32包括扩张区域280,该扩张区域280例如可以包括沿锚柱32的激光切割部件。扩张区域280有助于锚柱32响应施加至锚柱的轴向拉力而动态延长,这有助于锚定件30响应施加至锚定件的径向向内的压力而轴向拉长。图18示出了一种替代的可扩张元件290,其包括可以通过施加轴向拉力而被拉长并伸直的弯丝或杆的,以有助于锚定件响应施加至锚定件的径向向内的压力(和因此通过锚柱锁定元件260和锚定件锁定元件34之间的互相作用而施加至锚柱32的轴向拉力)而轴向拉长。
元件290另外或者替代地可以用作锁定对准部件。在这样的结构中,元件290可选地可以不是可扩张的。更一般地,锚柱32可以包括通过可伸长构件连接的近端和远端。
图19示出了锚柱32的另一种变形,锚柱32具有另一种替代的锁定对准部件262。在图19中,致动器106b施加指向近侧的力,使得锚柱锁定元件260和锚定件锁定元件34彼此接近以允许系统锁定。锚定件锁定元件34确定了锁宽W1。在本实施方式中,锁定对准部件262包括基本上宽于锁宽W1的锚柱锁定元件锁定区域或锁宽W2,例如,至少是锁宽W1宽度的大约两倍。该增加的宽度提高了锚柱和锚定件锁定元件互锁的可能性,即使在失准角度很大的情况下也是如此。在图19中,锚柱32和锚定件锁定元件34被设置为处于示范性的大约10°的失准角。
下面参照图20,示出了图14中的锚柱32的变形以及示范性的致动器106b和释放致动器112。在图20中,致动器106b示范性地包括具有和锚柱32的致动器连接元件250相匹配的锚柱连接元件302的杆300。锚柱连接元件302和锚定件连接元件250各自的倾斜的凸轮表面304和305形成了锚柱连接元件302和锚定件连接元件250之间的交接面。致动器106b相对于锚柱32的近侧运动通过凸轮表面被转化为两个元件之间的侧向力,以起到从致动器106b分离和释放锚柱32的作用。释放致动器112,示范性地为管310,可以在致动器300上方被推进以盖住锚柱和致动器106b的凸轮表面交接面,从而形成可释放的连接机构,用于将锚柱固定至致动器,即使在向致动器施加轴向拉力期间也是如此。为了从致动器106b分离锚柱32,例如在锚定件30的扩张和锁定之后,释放致动器112可以相对于致动器106b被收回到图20所示的位置,从而从凸轮表面304和305上去除约束并允许锚柱和锚定件被拉动而分离。为了致动可释放连接机构,例如为了从凸轮表面304和305上去除约束,释放致动器112优选地相对于致动器106b被收回小于约1英寸。
下面参照图21,介绍一种用于将锚柱32的变形连接至致动器106b的变形的替代的可释放连接机构。在图21A和图21B中,锚柱32具有致动器连接元件320,示范性地为锚柱内放大的近侧开口,该锚柱32与致动器106b的锚柱连接元件330,示范性地为致动器的放大的球、按钮或者其他远侧突起紧配合。元件330的倾斜提供了与开口320的内表面相接的凸轮表面。元件330和开口320之间的凸轮交接面的角度将致动器106b相对于锚柱32的近侧运动转化为致动器106b和锚柱32之间的侧向运动,从而分离这些元件。释放致动器112,示范性地为管310,盖住紧配合的可释放连接机构,以防止锚柱连接元件相对于致动器连接元件侧向运动,从而可释放地将锚柱连接至致动器106b。在图21C中,管310相对于锚柱和致动器收回,这允许锚柱和致动器连接元件之间的侧向运动,从而从锚柱32分离致动器106b。如果管310不被收回,那么当然还是致动器106b的近侧运动从近侧移动锚柱32和锚定件的远侧部分。
图22示出了图21中的可释放连接机构的一种变形。在图22的变形中,锚柱32的致动器连接元件320可以通过在连接元件上方推进释放致动器112而从基本圆形的外形变形为椭圆或者“数字8”的外形。这就构成了可释放连接机构。在图22A和图22B的变形的外形中,致动器106b的锚柱连接元件330被与锚柱32的变形的致动器连接元件紧配合。在图22C中,释放致动器112相对于锚柱和致动器的收回允许致动器连接元件320弹性地恢复其未变形或静止结构,从而允许将锚柱32从致动器106b分离。致动器连接元件320可以例如用形状记忆材料例如镍钛诺制成。在释放致动器112被收回时,锚柱连接元件330上的凸轮表面331和元件320内部的对应表面将致动器106b相对于锚柱32的近侧运动转化为元件330相对于元件320的侧向运动。
在图23的变形中,锚柱连接元件330是可变形的(如图23A和图23B),而锚定件连接元件320可以与锚柱连接元件紧配合。图23C示出了在管310被收回后锚柱连接元件330处于其静止结构下,从而释放锚柱连接元件320。显而易见的是,对于本文中介绍的很多或者所有的两段式锁定或者连接元件来说,元件的位置可以是可逆的。
在图24中,锚柱连接元件330包括缠绕部分332,缠绕部分332可以通过示范性地为锁孔的锚定件连接元件320被插入,向回缠绕,然后用释放致动器管310覆盖以将缠绕部分332约束为缠绕结构,如图24A所示。释放致动器管310可以被相对于缠绕部分收回以弹性地或者动态地(例如通过相对于锚柱32收回致动器106b)将缠绕部分重新成形为基本伸直的结构,用于释放锚柱和致动器之间的连接,如图24B所示。缠绕部分332优选地用形状记忆材料例如镍钛诺制成,或者用弹性材料例如弹簧钢制成。
图25示出了锚柱、致动器和锚定件锁定元件的另一种变形。在图25中,锚柱32包括锚柱锁定元件260和示范性地为锁孔的致动器锁定元件264,致动器106b被设置为可逆地从中穿过。锚定件锁定元件34示范性地包括带扣,带扣可以例如由截断管材或者能弹性弯曲的材料制成。锚定件锁定元件34包括用于将带扣连接至锚定件30的锚定件或编织物连接元件340,和用于将带扣和锚柱锁定元件260互锁的锁片342,示范性地为穿过锚柱32形成的槽。致动器106b因此致动锚柱(并因此致动锚柱连接的锚定件的远端)以及锚定锁。可以通过从近侧拉动控制丝的一端以将控制丝从开口264拉过并拉出而从锚柱(并因此从锚定件)释放致动器106b。
锚定件锁定元件34还包括可选的解锁致动器连接件344,示范性地为一对锁孔,从中穿过的解锁致动器350被可释放地连接至锚定件锁定元件34。解锁致动器350示范性地包括控制丝。将带扣34的锁片342锁定在锚柱32的槽260内,施加至解锁致动器350的指向近侧的力可以从槽中移出锁片,从而解开带扣34和锚柱32并允许锚定件被收回和拉长。解锁可以被用于例如将锚定件和瓣膜设备重新定位或收回,即使在设备已经被锁定在完全展开结构下之后也同样可行,如前文中参照图3所述的内容。
图26示出了致动器、锁定致动器和释放致动器的另一种变形。如同其他的锚定件锁定元件,本实施方式中的锚定件锁定元件34被连接至锚定件的近端,而锚柱32的远端被连接至锚定件的远端。为了便于图示,在图26中未示出锚定件。为了图示的目的,在图26中也没有示出解锁致动器。
如图所示,致动器106b致动锚柱32(并因此致动锚柱连接的锚定件远端)和在锚柱锁定元件260和锚定件锁定元件34之间形成的锁。在图26A中,释放致动器112穿过致动器106b以致动锚柱32和致动器106b之间的可释放连接机构。图26B提供了可释放连接机构的细部视图。致动器106b包括缠绕部分360,该缠绕部分360穿过致动器连接元件264并绕锚柱32的末端缠绕。缠绕部分360可以包括由形状记忆材料例如镍钛诺构成,或者由可变形材料例如可弹性变形材料构成。
缠绕部分360还包括用于接合释放致动器112的第一开口362,示范性地为穿过致动器106b的腔Lu的丝或杆。腔体的壁在相对于致动器推进和收回释放致动器时起到线性支承和/或动作引导的作用。致动器106b还包括可以与第一开口362对齐以接合释放致动器112的第二开口364,如图所示。如图26C的截面图中所示,缠绕部分360,特别是缠绕部分的弯曲部分361,起到弹性元件的作用以迫使第一开口不再对齐第二开口。用这种方式,释放致动器112可以通过第一开口362和第二开口364被紧配合或摩擦配合。从第一和第二开口的近侧收回释放致动器可以致动可释放连接机构,以弹性地或者动态地解开缠绕部分360并从锚柱32释放致动器106b。致动器106b的缠绕和/或弯曲部分360/361示范性地被设置在致动器的远端。
对于本领域普通技术人员来说显而易见的是,图26中的可释放连接机构也可以被用于将致动器106a连接至编织锚定件30。更一般地,缠绕部分360在锚定件致动元件106上提供了适用于和锚柱或锚定件致动器连接元件(例如图26中的元件264,或锚定件30的编织物的丝)上的第二形状相配合的示范性的第一形状,以基本上防止锚定件致动元件和锚定件之间相对的远侧或近侧运动。该设备还包括适用于致动可释放连接机构的释放致动器。释放致动器适用于被移动以允许第一形状和第二形状之间的相对运动。这种相对运动可以将第一形状和/或第二形状改变为第三形状,以允许锚定件致动元件和锚定件或锚柱之间相对的远侧或近侧运动。而且,这种相对运动可以从锚定件或锚定件连接元件中分离锚定件致动元件。
图27示出了图26中的锚定件锁定元件的一种变形。在图27中,锚定件锁定元件34包括锁定对准部件370。部件370包括接合部分372,示范性地为锁环,其适用于在接合锚定件锁定元件34之前(也就是在接合锚定件锁定元件的锁片342之前)将锚柱32与锚柱锁定元件260接合。部件370确保在锁定之前对齐锚柱和带扣。而且,部件370给锚定件锁定元件34额外增加了强度并在心脏舒张期间当设备10的瓣膜20关闭时克服加至元件34的内向的力。
下面参照图28,介绍图27中设备的致动。如图28A所示,锚定件锁定元件34例如通过用锚定件致动器106a将指向远侧的力施加至锚定件而被从远侧相对于锚柱32推进,以从远侧移动锚定件的近端部分同时通过致动器106b保持锚柱32的位置。可选地或附加地,指向近侧的力也可以通过致动器106b被加至锚柱32,同时保持锚定件近端的位置以从近侧移动锚定件的远端部分。锁定校准部件370在锚定件锁定元件34的锁片342和锚柱锁定元件260互锁之前接合锚柱的近端,从而确保准确对齐。锚柱32相对于带扣34的连续收回将锚柱锁入带扣内,如图28B所示。这样也可以将设备10扩张为例如图1B和图2C中的完全展开结构。接下来,释放致动器112被从近侧相对于致动器106b收回,这使得致动器的缠绕部分360弹性地或动态地向外转动,从而将第一开口362和第二开口364带离对齐状态。致动器106b相对于锚柱32的近侧收回将缠绕部分360从锚柱32的致动器连接元件264移除。
图29示出了图27和图28中的设备的一种变形。在图29中,锚定件锁定元件34由锁环380构成,而锚柱锁定元件260由锚柱32的缠绕或弯曲的近端构成。弯曲的近端也构成致动器连接元件264。致动器106b的缠绕部分360被绕锚柱32的弯曲端缠绕。释放致动器112,穿过致动器106b的第一开口362和第二开口364,可释放地固定该连接。释放致动器还包括有助于使致动器穿过示范性地为锁孔的锚柱32的释放致动器连接元件392的绳结390。当穿过元件392设置时,释放致动器112还起到防锁定机构的作用,以防止锚柱32的弯曲近端和锚定件锁定元件34的锁环380锁在一起。
在使用时,锚柱32的近端可以通过锚定件锁定元件34的锁环380被收回。释放致动器112随后可以相对于锚定件致动器106b和锚柱32被收回,以使得释放致动器被设置在锚柱的连接元件392的近侧。然后,锚柱32可以被允许从远侧推进,直到其弯曲的近端套住元件34的锁环380并与其锁定在一起为止。释放致动器112相对于致动器106b的连续收回有助于从锚柱分离致动器,如上所述。
下面参照图30,介绍锚柱32的一种实施方式,其被设置为锁定在锚定件30的编织物上,与独立的锚定件锁定元件34相对。锚柱锁定元件260示范性地包括夹住锚定件编织物以将锚定件锁定在展开结构下的弯片400。
图31示出了锚定件锁定元件34的一种变形的锁定和解锁。图31中的锚定件锁定元件34与前面参照图25和图26介绍的元件34的带扣变形相类似。但是,图31中的变形由被弯曲形成缠绕或弯曲部分的一条形材料构成。图31A示出了锁定之前的设备,图31B示出了已锁定的结构,而图31C示出了通过将指向近侧的解锁作用力加至解锁致动器350而解锁的过程。
图32示出了可释放致动机构的又一种实施方式。锚定件锁定元件34由设置在锁片412近侧的锁定校准机构410构成。如图所示,锁定校准机构410接合锚柱32的远端,以在锚柱锁定元件260和锚定件锁定元件34的锁片412锁定之前将锚柱和锚定件锁定元件对齐。锁定校准机构410给锚定件锁定元件34额外增加了强度并在心脏舒张期间当设备10的瓣膜20关闭时克服加至元件34的内向的力。有利地,内向的力用作将设备10保持在锁定结构下。机构410可选地可以由截断管材制成。
图33示出了可以由截断管材制成的锚定件锁定元件34的一种变形。如图33A和图33B所示,元件34由用于接合构成锚柱锁定元件260的锚柱32的弯曲近端的锁片420构成。为了将锚柱锁定至元件34,锚柱的弯曲远端通过致动器106b在锚柱32上的近侧拉力作用被从近侧收回锁片420同时元件34被保持静止,如上所述。随着锚柱的弯曲端进入锚定件锁定元件34,锚柱的弯曲端通过将元件34的远侧边缘与弯曲端的外表面相结合而被向内顶起。一旦锁片420的近端、锚柱的弯曲端同时向外移动,就锁定该设备并防止随后的锚柱32相对于元件34的远侧运动。为了解锁该设备,锚柱的弯曲部分通过致动器106b被进一步从近侧抽出直到弯曲部分的尖端移动进入元件34内成形的开口422为止。如图33C和图33D所示,锚柱例如通过锚定件30的编织物的弹性扩张相对于元件34的弹性远侧推进,通过锚柱弯曲部分的下侧和开口422的内表面的凸轮接合使锚柱32的弯曲近端变形并拉直,从而允许致动器106b滑离锚柱32,以解锁设备10。锚柱32的弯曲部分可选地由形状记忆材料制成,以使得锚柱能够恢复其弯曲的外形以用于解锁之后的后续再次锁定。
图34示出了锚柱32和锚定件锁定元件34的一种变形。锚定件锁定元件34示范性地包括接合并进入锚柱锁定元件260的槽的弯曲部分35,以在锚柱32通过致动器106被从近侧拉入元件34时锁定锚定件。在锁定之后,锚柱32通过致动器106b连续近侧收缩将元件34弯曲部分的远端与锚柱32的凸轮表面430相接合。锚柱32的弹性远侧推进(例如通过锚定件到其自身静止结构的弹性收回和拉长)随即使元件34的缠绕端变形并伸直,从而允许从锚柱32分离锚定件锁定元件34,将设备解锁。
图35和图36示出了锚定件锁定元件34另外的带扣式变形。锚柱32进入锚定件锁定元件34的近侧运动(通过例如致动器106b)将元件34的弯曲部分700的底面702与锚柱32的近端相接合。锚柱32相对于元件34的进一步近侧运动将弯曲部分700向前推进,直到弯曲部分700的弯曲端704碰到并弹性地进入锚柱32内的开口260为止,将设备锁定。图36的变形示出了用缝合线或类似物穿过元件34内的开口340到锚定件30的编织物的连接。锁可以通过解锁致动器350解开。
下面参照图37,介绍了一种锚柱32和带有棘轮锁的锚定件锁定元件34的实施方式。锚柱32包括前述的被可释放地固定至致动器106b的锚柱连接元件302的致动器连接元件250。(其他的可释放连接机构也可以被选用。)锚柱32还包括编织物连接元件430和瓣膜连接结构432。在图37的变形中,瓣膜连接结构432包括从锚柱32延伸出的锁片433,以及穿过锚柱32的多个孔434和穿过锁片433的多个孔435。替换瓣膜20可以通过将瓣膜穿过孔434和/或435缝合至瓣膜连接结构而被连接至锚柱32。
锚柱32还包括具有多个倾斜面包括凸轮表面442和摩擦表面443的棘轮锁定元件440。倾斜面被沿锁片433的任意一侧设置,用于渐进和锁定棘轮锚定件锁定元件34。锚定件锁定元件34包括在瓣膜连接元件任意一侧上的棘轮齿450,棘轮齿450随着锚柱32通过元件34被从近侧收回而抵住表面442并锁定锚柱32的元件440的摩擦表面443。有利地,沿锚柱32设置多排倾斜面有助于将锚柱和元件互锁在多个离散的位置。
元件34包括容纳锚柱32的近侧和远侧槽452,以及便于从中穿过锁片433(并因此穿过瓣膜20)的中央纵向槽453。为了便于将锚柱和锚定件锁定元件对齐,致动器106b可以在锚柱接近并锁定至锚定件连接元件34之前被穿过槽452设置。元件34可以沿棘轮锁定元件440被渐进至任意位置,以实现任何需要的锁定结构和设备10的扩张程度。瓣膜连接结构432,以及替换瓣膜20,可以被设置在展开后的棘轮锁的近侧或者与棘轮锁共线(也就是说既不是棘轮锁的近侧也不是棘轮锁的远侧)。元件34还包括用于将元件连接至解锁致动器例如前述的解锁致动器350的一个或多个解锁致动器连接454,以通过施加将棘轮齿450从摩擦表面443移出的指向近侧的解锁作用力解开元件34。
图38示出了图37中设备的变形。图38中锚柱32的棘轮锁定元件440包括多个棘轮槽444,锚定件锁定元件34的棘轮齿450可以被锁定在槽内。棘轮齿450包括近侧摩擦表面456和远侧凸轮表面457,以便于通过槽452将锚柱32从近侧收回以通过棘轮槽444渐进凸轮表面457,但是一旦棘轮齿450通过将棘轮槽与摩擦表面456锁定而与棘轮槽444接合,就阻止锚柱的远侧推进。与图37中的变形相同,锚定件锁定元件34是不可锁的且包括解锁致动器连接件454。与图37中的变形相比,棘轮锁被设置在瓣膜连接结构432的近侧,并因此也在替换瓣膜20的近侧。在图38A中,瓣膜连接结构432包括槽436而不是锁片433。
图39示出了图37中的棘轮锁的另一种变形。在图39中,锚柱32的棘轮锁定元件440仅沿锚柱的一边延伸。因此,锚定件锁定元件34包括单边的棘轮齿450,用于在锚柱32被从近侧通过元件34收回时抵住表面442并锁定锚柱32的元件440的摩擦表面443。
图39中的设备还包括沿解锁致动器连接件454可释放地连接至锚定件锁定元件34的解锁或调节致动器500。致动器500包括两个分别或同时致动的元件:调节元件510和释放元件520。调节元件510包括细长构件512,其具有突起514和腔515,以及具有凹口518的远侧延伸部516,凹口518具有可选的凸轮表面519。释放元件520包括细长构件521,其例如可以由心轴构成,并被设置用作穿过调节元件510的突起514的腔515的通道。致动器500的细长元件512和521优选地穿过输送系统100延伸至患者体外,用于被专业医务人员分别或同时推进和/或收回。
如图39A所示,致动器500的调节元件510的凹口518可以在设备10展开期间被设置在锚定件锁定元件34的解锁致动器连接454内。如图39B所示,锚定件锁定元件34通过相对于锚定件锁定元件34从近侧收回致动器106b而被锁定在锚柱32的棘轮锁定元件440内。释放元件520随即被相对于调节元件510推进,以将细长构件521设置在调节元件510的远侧延伸部516附近的解锁致动器连接件454内。这用于将致动器500沿调节元件510的凹口518摩擦锁定或者紧配合在连接件454内。因此,通过专业医务人员同时推进和/或收回致动器500的调节和释放元件来驱使锚定件锁定元件34和致动器500一起移动。显而易见的是,可选地可以在设备10完全展开之间将致动器500与锚定件锁定元件34摩擦锁定在一起。而且,一个或多个致动器500可能有助于或者被用于在致动器106a的适当位置以展开设备10。
如图39C所示,可以通过用致动器500向棘轮齿450施加侧向解锁作用力拉动棘轮齿离开棘轮锁定元件440的摩擦表面443而根据需要解开或调整锚定件锁定元件34和锚柱32之间形成的锁。致动器500随即可以被从远侧推进或者如图39D所示被从近侧分别相对于棘轮锁定元件440和锚柱32推进以进一步扩张或者部分收缩锚定件30(进一步扩张可选地可以通过进一步沿棘轮锁定元件440的凸轮表面442渐进棘轮齿450而实现,例如通过进一步从近侧收回致动器106b进行,为了清楚起见在图39C-39F中未示出致动器106b)。锚定件致动元件106可以有助于控制这种锚定件30的扩张或收缩。
在所需位置(重新)定位时和/或已经达到所需的锁定程度时,侧向解锁作用力可以被从棘轮齿450移除,以再次将锚定件锁定元件34沿棘轮锁定元件440锁定至锚柱32,如图39E所示。为了完成设备10的展开,调节致动器500和致动器106b,以及致动器106a(未示出),可以被从设备分离。在图39F中,致动器500的释放元件520被相对于调节元件510从近侧收回,从而将释放元件520的细长构件521从锚定件锁定元件34的解锁致动器连接454移除。这就解除了凹口518和连接件454之间的紧配合。相对于锚定件锁定元件34从近侧收回致动器500即可将致动器500的调节元件510从锚定件锁定元件34的连接件454分离,如图39G所示。沿凹口518的可选凸轮表面519可能有助于这种分离。在图39H中,致动器106b通过相对于致动器收回释放致动器112而被从锚柱32分离,如上所述。
下面参照图40,介绍可调节棘轮锁定元件的另一种变形。如图40A所示,锚柱32包括具有腔471和示范性地为与腔471连通的多个槽的棘轮锁定元件472的管470。锚柱32还包括瓣膜支撑结构或连接元件474和编织物连接元件476。
可以由截断管材制成的锚定件锁定元件34包括基本圆柱形的具有编织物连接元件480、腔482和锁片484的结构。如图40B的俯视图中所示,锚定件锁定元件34的锁片484被设置为锁定在锚柱32的棘轮锁定元件472的槽内。如图40C的俯视图中所示,调节致动器490,示范性地为具有用作凸轮表面的锥形远端494的心轴M,可以被穿过锚定件锁定元件34的腔481和锚柱32的管470的腔471推进,以将锁片484从锚柱32的锁定槽移出,从而将锚柱从锚定件锁定元件解开。这样有助于例如调节设备10的锁定/扩张程度、设备10的重新定位、设备10的取出等等。
图41示出了锚定件锁定元件34的一种变形,其中锁片484被沿不同的轴设置。这样可以在锚柱32和锚定件锁定元件34之间提供更多的固定锁。图42示出了锚柱32的一种变形,被设置用于和锚定件锁定元件34的变形一起使用。在图32中,锚柱32包括连接棘轮锁定元件472的槽的凹槽478。凹槽478不与锚柱32的管470的腔471连通。这样,凹槽可以用作锁定校准机构,以沿锚柱32引导锚定件锁定元件34的锁片484和棘轮锁定元件472,如图42B的俯视图中所示。
下面参照图43,介绍一种致动图41中的变形的方法。如图43A所示,调节致动器490被初始地设置为穿过锚定件锁定元件34的腔482并设置在锚柱32的腔471内。锚柱32随即可以相对于锚定件锁定元件34从近侧例如通过致动器106b(未示出)被收回。在图43B中,致动器490用作防锁定机构,以排除将锁片484锁定在棘轮锁定元件472内。在图43C中,致动器490被相对于锚柱32和锚定件锁定元件34收回,从而打开管470的腔471并允许锁片484穿过棘轮锁定元件472的槽,从而将锚柱锁定至锚定件锁定元件。在图43D中,致动器490被在腔471内再次推进,以使得心轴M的锥形远端494用作凸轮表面以随着致动器的推进将锁片484挤出腔471。这就将锚柱从锚定件锁定元件解开以便于调节、重新定位或取出设备10。在图43E中,通过相对于锚柱32重新定位锚定件锁定元件34,并因此相对于棘轮锁定元件472重新定位锁片484来调节装置的锁定/扩张程度。在适当地调节后,致动器490可以从锚柱32的管470的腔471中取出,如图43F所示。锁片484弹性地返回棘轮锁定元件472的槽内的锁定结构。
下面参照图44,介绍锚定件/致动器106a的一种实施方式。致动器106a包括具有近侧延伸部602的细长构件600,其可以通过例如环氧处理、紫外线固化处理等方式被连接至例如如前所述的输送系统/展开工具100(参见图1)的多腔杆或导管108。腔601从近侧延伸部602穿过细长构件600延伸至可释放连接机构604。可释放连接机构604可释放地将致动器106a连接至锚定件30的编织物。该机构包括释放致动器112并示范性地与前述图26-28中的可释放连接机构相类似。释放致动器112,示范性地为心轴,穿过多腔杆108的腔Lu并随后穿过致动器106a的腔601到达机构604。
致动器106a还包括在向锚定件30施加锚定件致动作用力时影响锚定件致动器形状的定形元件606。这些元件可以包括例如致动器的直径减小部分,致动器的壁厚减小部分和/或锚定件致动器内成形的切口。施加锚定件致动作用力可以例如给致动器106a提供如图44A中所示的外形。该外形可以有助于锚定件30/设备10的扩张。显而易见的是,定形元件可以被设置在任意的锚定件致动元件106内,包括前述的所有致动器106b的变形。
如图45所示,可释放连接机构604包括缠绕部分610,缠绕部分610例如可以穿过锚定件30的编织物并绕锚定件的近端缠绕。缠绕部分610可以由形状记忆材料,例如镍钛诺,或可变形材料,例如可弹性变形材料制成。缠绕部分包括用于接合释放致动器112的第一开口612。细长构件600的腔601的壁可以在相对于致动器推进和收回释放致动器时起到线性支承和/或动作引导的作用。致动器106a还包括可以与第一开口612对齐以接合释放致动器112的第二开口614,如图所示。缠绕部分610,特别是缠绕部分的弯曲部分611,起到弹性元件的作用,以迫使第一开口不再对齐第二开口从而接合并保持释放致动器112就位。
如图45C所示,当相对于致动器从近侧收回释放致动器时,缠绕部分610弹性地或动态地向外转动。随后,相对于锚定件30从近侧收回锚定件致动器106a以将缠绕部分610,并因此将致动器106a从锚定件解开。缠绕部分610的表面616可以在缠绕部分610的内表面沿锚定件编织物30滑动时用作凸轮表面以便于进行这种分离。
用这种方式,释放致动器112可以被紧配合或摩擦配合穿过第一开口612和第二开口614。从第一开口和第二开口的近侧收回释放致动器以致动可释放连接机构604来弹性地或动态地从锚定件30解开缠绕部分610和释放致动器106a。致动器106a的缠绕部分610示范性地被设置在致动器的远端。
参照图46,介绍可释放连接机构604的一种变形。在图46中,缠绕部分610示范性地包括用作校准机构以将机构604的缠绕部分与细长构件600对齐的锁片618。这样可以有助于穿过机构604推进释放致动器112。图47示出了锁片618的一种变形,其中锁片是圆形的。这样可以减小摩擦,提供一个防止损伤的表面等。其他可用于锁片618的形状是显而易见的。可选地,被载入的锁片618可以在装入元件630时起到弹簧元件的作用,如图47B所示。在此结构中锁片618向元件630施加力,以使得在收回元件112时将630弹出。锁片618用这种方式在元件112上施加约束力以降低过早释放的危险。
图48示出了缠绕部分610的一种变形,包括静止结构下基本笔直的远侧区域,如图48C所示。可以预见提供沿缠绕部分610基本笔直的远侧区域能够有助于致动器106a从锚定件30分离,也就是说,可以降低沿锚定件编织物阻塞缠绕部分的危险。缠绕部分可以被弹性变形,用于使释放致动器112穿过第一开口612,如图48A和图48B所示。
下面参照图49,介绍和可释放连接机构604一起使用的释放致动器112的变形。在图49A中,释放致动器包括简单的心轴。在图49B和图49C中,释放致动器包括具有摩擦表面621的突起620。在图49D中,致动器112包括线圈622。在图49E-49H中,致动器包括绳结624,可以用作凸轮表面,如图所示。绳结还可以给专业医务人员提供触觉反馈。在图49I和图49J中,释放致动器包括被设置在致动器远端的近侧的球或滑块626。在图49K和图49L中,球626被设置在致动器112的远端。球可以用作凸轮表面。在图49M中,致动器112包括具有近侧凸轮表面629的突起628。在图49N中,致动器包括具有摩擦表面431的椭圆形突起430。致动器112的其他变形将是显而易见的。
下面参照图50,介绍输送系统/展开工具100的一种实施方式。图50A提供了多腔导管108和护套110的细部视图。如前所述导管108包括中心腔和多个周向分布腔Lu。
如图50B中所示,致动器106a通过近侧延伸部602被连接至导管108,以使得腔601被同轴地设置在导管的腔Lu内。释放致动器112穿过腔Lu和601延伸。致动器106a沿可释放连接机构604被从远侧连接至锚定件30的编织物。为了清楚起见,在图50B中示出了单个的致动器106a,但是优选地应设置多个这样的致动器,如下面图51中介绍的内容所述。
图50B还示出了致动器106b。致动器穿过导管108的腔Lu并穿过锚定件锁定元件34延伸至锚柱32(未示出)。也设有解锁致动器350并使其穿过腔Lu延伸以解锁锚定件锁定元件34的致动器连接件344。锚定件锁定元件34示范性地包括前面参照图31介绍的变形。该元件沿锚定件连接元件340被连接至锚定件30的编织物。除了致动器106a,图50B中还示出了单个的锚定件锁定元件34和致动器106b。这仅仅是为了清楚起见,可以设置多个例如三个这样的致动器。
下面参照图51,示出了输送系统/展开工具100和多个用于将设备10可释放连接至锚定件30的致动器106a与致动器106b。在图51A中,锚定件致动元件106a被连接至锚定件。在图51B中,该元件被从锚定件分离。
下面参照图52,介绍图50和图51中的输送系统/展开工具的一种变形,包括从一个整体结构中延伸出的多个臂部或致动器。可以从多腔杆108的远侧区域中延伸出的整体结构650,优选地由激光切割管材制成。结构650包括多个环绕设置的臂部652用作致动器。可扩张元件654可以被设置在臂部652之间并有助于在重新成形锚定件时约束臂部相对于其他臂部径向向外或向内。图52A示出了径向收缩结构下的臂部,而图52B示出了径向扩张结构下的臂部。缠绕部分655适用于绕锚定件编织物的近侧部分缠绕。开口656和657被成形在缠绕部分655内以接合释放致动器,如前面的实施方式中所述。
下面参照图53,介绍连接至替换瓣膜设备10的锚定件30的编织物的连接元件的各种形式。在图53A中,具有单个编织物连接孔660的锚柱32沿编织物的三个独立交叉口通过缝合线S被连接至锚定件30。图53B提供了一种用于在孔660和锚定件30之间走线的示范性技术的细部视图。图53C示出了连接件的一种变形,其中锚柱32包括多个编织物连接孔660。显而易见的是,除锚柱32之外的其他元件也可以用上述方式被连接至锚定件30,例如锚定件锁定元件34可以用类似方式被连接。
下面介绍的是用可释放连接机构来可释放地连接植入物的替代方法,例如用输送系统/展开工具来可释放地连接本文中介绍的编织锚定件的替代方法。
图54示出了包括捕获系统800、导管808(例如本文中介绍的多腔导管),和外护套806的输送系统802的远端的一种实施方式。图中的捕获系统800被连接至导管808,并通常适用于可释放地保持或捕获医疗植入物804的至少一部分,例如编织锚定件或者其他医疗植入物例如支架。捕获系统800通常包括多个表示为锁环的第一可致动元件830,其可滑动地与多个表示为指状元件的第二元件810相连。锁环830被示出为和指状元件810在第一位置接合,其中锁环830和指状元件810相配合,以捕获至少一部分医疗植入物804并防止其从输送系统802中被释放。
与上述的例如图44A至图52中的实施方式相类似,第一可致动元件通常以第一结构接合第二元件以捕获植入物。第一可致动元件和第二元件可以例如建立一个空间将医疗植入物捕获在内。在优选的实施方式中,第一可致动元件和第二元件接合,以限定一个具有固定形状的空间,例如空腔,在其中放置一部分植入物。具有固定形状的空间通常意味着其周长是固定的或者半固定的。植入物可以被容纳在该空间内或者放在该空间内且并不是必须连接至第一元件或第二元件。植入物也可以滑动地放入该空间内,并与第一元件或第二元件相接合。至少一部分捕获的植入物可以具有和部分第一及第二元件之一或两者都相同或基本相同的形状。例如,植入物的管形部分可以被装入指状元件的管形腔内。或者替代地,第一和第二元件可以包括各种允许在其间捕获植入物的形状。在所有这些不应被理解为穷举的实施方式中,都可以捕获植入物。
图55示出了包括指状元件810(其他部件未示出)的捕获系统800的一种实施方式。图56示出了具有远端822的指状元件810的一部分。指状元件810包括约束元件接口812、植入物接口820、第一阻挡元件814、第二阻挡元件816,和末端阻挡件818。
而多个指状元件优选地至少包括植入物接口、第一阻挡元件和末端阻挡件,可选的部件包括约束元件接口和第二阻挡元件。
图57示出了指状元件10的一种替代实施方式,包括植入物接口820、第一阻挡元件814,和末端阻挡件818。与图57中示出的指状元件相接合的锁环可以通过接合第一阻挡元件而被锁定,但并未被与指状元件一起锁定在与56中示出的指状元件相接合的锁环能够锁定的第二位置。
图58和图59示出了处于扩张结构下的连接系统800的一种实施方式,其中联接系统包括约束装置882。约束装置882与指状元件810的约束元件接口812(如例如图56中所示)相接合。所示出的约束装置882穿过指状元件的约束元件接口,从而限制联接系统径向方向上的最大扩张量。约束装置通常限制联接系统的膨胀量,指状元件通常也是如此,从而防止联接系统在输送医疗植入物期间过度扩张。
图58示出了处于扩张结构下的联接系统800。多个指状元件被固定至联接元件826,其与能够有助于连接至导管88远侧部分的孔元件828相连。
图60示出了约束装置882的一种替代的实施方式,其中约束装置并不穿过多个指状元件而是接合指状元件外表面上的约束元件接口。约束装置882能够适用于在指状元件扩张和/或收缩时利用例如由形状记忆材料或棘轮系统制成的约束装置以可控的方式扩张和收缩。
图61和图62分别示出了能够被用于本文介绍的输送系统和/或联接系统中的示范性锁环830的侧视图和剖视图。锁环830包括远端858并包括锁定元件834、锁止元件840、折叶852、通孔844、释放元件856,和弹出元件848。通孔844适用于容纳通常穿过锁环并与锁环内表面相接(如图10-13所示)的指状元件810。锁环和指状元件适用于彼此滑动地接合。
图63-67示出了联接系统的一种实施方式和一种从联接系统中释放至少一部分医疗植入物(未示出)的方法。图63示出了与指状元件810在第一位置接合的锁环830,以防止至少一部分医疗植入物804被从联接系统中释放。所示出的锁环830与指状元件810接合,以防止锁环830相对于指状元件810移动。锁环830包括适用于与指状元件810的第一阻挡元件810相接合以将锁环锁定在第一位置。将锁环与指状元件锁定在第一位置还可以防止至少一部分医疗植入物在输送植入物期间被从联接系统中释放。
图63-67还示出了适用于接合锁环830的释放元件856的释放致动器862。如下所述,释放致动器862适用于在输送装置内被输送并且适用于通过利用设置在患者体外的致动器例如本文中介绍的控制手柄施加致动力而被控制。
图64示出了捕获系统800的一种实施方式,其中释放致动器862已经致动锁环830的释放元件856,以从指状元件810解开锁环830。通过致动锁环的释放元件856,锁定元件834被从图63中的位置移动至图64中的解锁位置。锁环830还包括适用于和锁定元件834连接并匹配的锁止元件840,以在锁定元件被从锁定位置移开后防止锁定元件834的进一步移动。锁定元件834和锁止元件840均包括凸起838,均适用于改善和/或提高锁定元件834和锁止元件840之间的接合。凸起通常在锁定元件834和锁止元件840之间发生滑动之前增加了元件之间可以被施加的所用力。这能够在致动力被加至锁环以使其在第一和第二位置之间滑动时帮助稳定锁环并防止锁定元件和锁止元件打滑。锁环830的折叶852随着释放致动器862被致动而变形,允许从指状元件解开锁环。折叶852可以具有类似弹簧的性质或者记忆性质,以使得它具有返回初始位置的倾向。
锁定元件被从锁环释放之后,致动器上的指向近侧的力施加了致动力以将锁环从图64所示的位置移动至图65所示的位置。移动锁环通常包括在锁环的内表面接合指状元件时沿指状元件滑动锁环。
由释放致动器862的远端施加至释放元件856的致动力通常都朝向近侧,并能够从患者体外利用输送系统内的致动器来施加。由释放致动器施加至释放元件的致动力通常包括近侧和径向向内的力。本文中使用的术语指向近侧的力包括基本上指向近侧的力和/或沿径向向内的力。使用的术语指向近侧还包括从体外施加的指向近侧的力,它会带来被施加至可致动元件的指向近侧和/或沿径向向内的力。但是,基于锁环、指状元件,和释放致动器之间接合的结构,力的方向可以变化,并且可以基本处于同一方向或不同方向。
随着锁环穿过图64所示的位置移向65所示的位置,捕获元件832,通常是锁环的防止医疗植入物被从捕获系统中释放的那部分,向近侧移动,以允许医疗植入物804从植入物接口820弹出。在锁环移动至图65所示的位置时,弹出元件848与医疗植入物804相接合以从指状元件的植入物接口820中弹出植入物,例如一部分编织锚定件。第一可致动元件因此被致动,以从多个第二元件中释放植入物。
所示的弹出元件具有与指状元件的纵向轴线成约45度角的倾斜表面,以确保植入物从联接系统中可控地、光滑地弹出和释放。但是,所示出的角度仅仅是示范性的而不应理解为限制,且锁环的弹出元件也可以被设置为其他形式。
如图65所示,末端阻挡件818与锁环860的近端相接合,以防止锁环进一步向近侧运动。末端阻挡件通常有助于从患者体外将指向近侧的致动力均匀地分配至输送系统内的所有锁环。通常,从患者体外向输送装置施加单个指向近侧的致动力。该作用力优选地应尽可能均匀地分配至所有锁环(或者可选地分配至选定的锁环组,例如随后要被致动的锁环组),以使得所有锁环从近侧移动至第二位置(如图65所示)并弹出它们各自的部分植入物。一旦锁环接合末端阻挡件,加至该锁环的致动力通常就被分配至其他尚未完全移动至末端阻挡件的锁环。这有助于确保作用力的平均分配。末端阻挡件因此有助于确保植入物被从捕获系统中完全释放。
在植入物已经从捕获系统中被释放之后(如图65所示),释放致动器上的指向近侧的力的减小、释放,或者不连续使得折叶852返回其初始位置,并使得锁定元件834接合第二阻挡元件816,重新将锁环与指状元件锁定,如图66和图67所示。该锁定步骤确保锁环在致动力不再被加至释放致动器组时不会向远侧运动。
在锁环被重新锁定至指状元件之后,例如如图67所示,捕获系统可以通过在输送导管(例如多腔导管)上施加近侧力而被收回外护套中,从而迫使捕获系统从扩张结构收缩为外护套内的收缩结构,也可以在导管和捕获系统上方将外护套向远侧移动。这样输送系统能够被从患者体内取出。图68示出了一种可选的锁环830,连接一种可选的锁止元件840的实施方式,在通过释放元件856施加拉力时随着锁定元件834从锁环环体旋转脱离而与锁定元件臂部842互相作用。
图69示出了另一种替代的实施方式,其中锁环830的锁定元件834与指状元件810的第一阻挡元件814相接合,防止锁环的近侧运动。当向释放致动器施加拉力时,锁定元件834被从第一阻挡元件814释放,从而允许锁环从指状元件的远端滑离。一旦锁定元件被释放,锁环就会向近侧自由滑动从而从植入物保持元件中释放植入物。向释放致动器施加更多的拉力时,锁定元件就会被锁止元件840约束为过度旋转并有可能失效。在弹出元件848穿过植入物接口并在经过时弹出植入物之后,锁环即被收回至末端阻挡件818。
图70和图71示出了一种替代的实施方式,其中锁环830铰接元件被重新设置为连续的弹性元件。图70中所示的锁定元件834处于和第一阻挡元件814相接合的锁定位置。在向释放致动器(未示出)施加拉力时,锁定元件被从指状元件810解开并允许锁环向近侧滑动至图71所示的位置,在此锁定元件834与指状元件810被锁定在第二阻挡元件816内。
图70和图71所示的锁环可以由例如塑料材料制成,可以向其施加致动力而不会导致明显的永久变形。但是,锁环可以适用于单次使用并随即被丢弃,在此情况下锁环的变形就不再是关键因素。例如,可能只希望在使用期间避免灾难性的失效。
图72-75示出了一种替代实施方式,其中锁环830铰接元件被设置为连续的类似弹簧的装置。在图72中,释放致动器862介于指状元件810和锁环830之间。所示出的锁环处于锁定位置,其中锁定元件834(未示出)接合指状元件810的第一阻挡元件814。图73示出了释放致动器862的俯视图,其包括远侧区域846、空间850,和楔形元件854。释放致动器862具有灵活的包括空间850的弯曲远侧区域846,锁定元件834在处于锁定位置时穿过其中。在向释放致动器862施加指向近侧的力时,释放致动器862沿近侧方向移动,而楔形元件854开始楔入指状元件810和锁环830之间,迫使锁环830沿图72中箭头所示的方向向下。这使得锁定元件834从第一阻挡元件中脱离,从指状元件中解开锁环。随着近侧力继续被加至释放致动器862,楔形元件854接合未锁定的锁定元件834和/或部件846的近侧边缘接合锁环,二者之一或者全部情况下迫使锁环830沿近侧方向移动,在指状元件810上滑动,如图74所示。如图75所示,在释放致动器862将锁定元件834拉入图中所示位置时,锁定元件834接合第二阻挡元件816,防止锁环进一步的近侧运动。与本文中介绍的其他实施方式相类似,弹出元件848将在经过指状元件的植入物接口时弹出部分植入物。
图76示出了释放致动器组870的一种实施方式,包括多个从集线器872沿径向向外扩张的释放致动器862。所示的释放致动器与集线器集成为一个单元。释放致动器862包括释放致动器体864和释放致动器远端866。集线器872具有孔,穿过该孔允许放置组工具874,如图77所示。
图77示出了穿过释放致动器组集线器的孔的组工具874的一种实施方式。组工具874包括组工具远端876,其具有大于组工具体的直径以使得当向组工具施加近侧致动力时,组工具远端876可以和释放致动器集线器的集线端接合并向该组施加指向近侧的力。如上所述,释放致动器接合锁环,并在向该组施加指向近侧的力时,释放致动器向锁环施加指向近侧的力,从而例如从指状元件解开锁环或者从近侧将锁环相对于指状元件拉至第二位置。
在优选的实施方式中,捕获系统中释放致动器的数量优选地与捕获系统中锁环的数量相同,并优选地与指状元件的数量相同。但是,捕获系统可以包括任意数量的指状元件(并因此包括任意数量的锁环和释放致动器)。
但是,在一些实施方式中,锁环可以少于指状元件(类似地释放致动器也可以少于指状元件)。例如,可以有15个指状元件,但仅有10个锁环,甚至只有5个锁环。
在一些实施方式中,将指状元件设置为不同的结构可能是有利的。例如,在图54和图55中的植入物接口向径向向外的方向打开。但是,可能需要植入物接口向径向向内的方向打开。根据例如要输送的植入物的类型,这样可能可以提供更安全的输送。在又一些实施方使中,某些植入物接口可以向径向向内的方向打开,而某些植入物接口可以向径向向外的方向打开。在其他的实施方式中,某些指状元件可能不带有植入物接口。但是,也可以使用任意其他的指状元件和锁环的结构。
尽管图77中只示出了一个带有五个释放致动器的组,但是图78示出的实施方式中的捕获系统包括三个图77所示的释放致动器组870。三个组中的每一个都具有五个释放致动器,因此捕获系统包括十五个释放致动器。
图76-79中所示的每个释放致动器组中的释放致动器彼此之间基本等距设置。换句话说,相邻的释放致动器之间的角度A(如图77所示)相等。因此,相邻的释放致动器之间的角度通常是360除以组内释放致动器数量所得的商。但是,每个组内都可以有任意数量的释放致动器,而各组中释放致动器的数量可以不同。很多因素都会影响所使用的组的数量,或者每个组中的释放致动器的数量,例如要输送的医疗植入物的类型。
图79示出了处于“层叠”位置下的图78中的组,使得组的集线器与相邻组的集线器相接合。组可以简单地被设置在图79所示的位置内而无需彼此固定,或者组可以用例如粘合剂、机械连接,或者其他任何可以将组连接在一起的方式而互相连接在一起。组优选地彼此层叠,使得相邻的释放致动器之间的角度B(如图79所示)能够容纳指状元件之间的角度。图79示出了十五个释放致动器,设置为相邻的释放致动器之间的间距基本相等。
使用多个组的捕获系统的一个优点是集线器直径要小于仅使用一个组时的直径。例如,一个具有十五个释放致动器的组所具有的集线器的直径将大于图79中所示的集线器的直径(假定释放致动器的宽度保持不变)。与具有较大直径的集线器相比,较小直径的集线器意味着允许较小直径的输送系统。这在血管内输送医疗植入物时可能是有利的。另外,随着集线器直径的增大(在组中增加释放致动器时会出现这种情况),集线器会在致动组工具874期间经受较大的峰值应力。向组工具施加近侧作用力时,组工具远端接合集线器,迫使其向近侧方向移动。因为释放致动器的远端接合锁环(并导致锁环上的致动力),集线器会经受一定大小的应力,随着集线器直径的增加,集线器最大直径部分上的应力大小也会增加,有可能导致集线器失效。因此,保持集线器直径尽可能小也可以是有利的。
本文中介绍的捕获系统可以具有任意数量的释放组,而且一个组中可以有任意数量的释放致动器,而均不背离本发明。同时尽管图77-79中所示的组包括的释放致动器基本垂直于组工具的纵向轴线延伸,但是释放致动器在输送(导管内收缩)期间也可以沿更多的远侧方向延伸,通常是在捕获系统处于扩张结构下(如图59所示)时沿远侧方向延伸。
尽管已经结合优选实施例对本发明进行了介绍,但是本领域普通技术人员应该理解可以在下述权利要求的保护范围内进行各种修正。因此,本发明的保护范围不应以任何方式理解为被上述说明内容所限制,而应理解为完全由参照下述权利要求的内容确定。

Claims (25)

1、一种能够在输送系统内可释放地捕获医疗植入物的捕获系统,其中所述输送系统能够通过体腔输送所述医疗植入物,所述捕获系统包括:
多个指状元件;和
多个可致动元件,每个可致动元件被构造成与所述多个指状元件中的一个可滑动地接合;
其中所述多个可致动元件中的每一个都能够在第一位置接合所述多个指状元件中的一个,以捕获至少一部分所述医疗植入物,所述多个可致动元件中的每一个都能够在第二位置接合所述多个指状元件中的一个并从联接系统释放所述一部分医疗植入物。
2、根据权利要求1所述的系统,其中,所述多个指状元件和所述多个可致动元件能够接合并锁定在一起。
3、根据权利要求2所述的系统,其中,所述多个指状元件和所述多个可致动元件能够在所述第一位置接合并锁定。
4、根据权利要求2所述的系统,其中,所述多个指状元件和所述多个可致动元件能够在所述第二位置接合并锁定。
5、根据权利要求2所述的系统,其中,所述多个可致动元件能够通过指向近侧的力被致动。
6、根据权利要求2所述的系统,其中,所述多个可致动元件能够被致动以从所述多个指状元件解锁。
7、根据权利要求6所述的系统,其中,所述可致动元件包括锁定元件,所述锁定元件能够与所述指状元件相接合以将所述可致动元件与所述指状元件锁定在一起,所述可致动元件还包括锁止元件,所述锁止元件能够在所述可致动元件从所述第一位置解锁后防止所述锁定元件运动。
8、根据权利要求7所述的系统,其中,所述锁定元件和所述锁止元件被成形为互相匹配。
9、根据权利要求6所述的系统,其中,所述多个可致动元件能够被致动,以从所述解锁位置运动到所述第二位置。
10、根据权利要求9所述的系统,其中,所述可致动元件能够在所述多个指状元件的外表面上滑动。
11、根据权利要求9所述的系统,其中,所述多个可致动元件能够通过释放作用在所述多个可致动元件上的致动力而被锁定在所述第二位置。
12、根据权利要求11所述的系统,其中,所述多个可致动元件能够通过释放指向近侧的致动力而被锁定在所述第二位置。
13、根据权利要求1所述的系统,还包括多个释放致动器,其中所述多个可致动元件能够被所述多个释放致动器致动。
14、根据权利要求13所述的系统,其中,所述多个释放致动器包括多个释放致动器组。
15、根据权利要求1所述的系统,其中,所述多个指状元件包括植入物接口,所述植入物与植入物接口在所述第一位置处相接合。
16、根据权利要求15所述的系统,其中,所述植入物接口布置在所述多个指状元件的远端附近。
17、根据权利要求15所述的系统,其中,所述植入物接口包括在所述指状元件内能够容纳所述植入物的空腔。
18、根据权利要求1所述的系统,其中,所述多个可致动元件和多个指状元件都不能联接到所述植入物。
19、根据权利要求1所述的系统,其中,随着所述可致动元件从所述第一位置运动到所述第二位置,所述植入物被从所述联接系统中释放。
20、根据权利要求19所述的系统,其中,所述可致动元件包括弹出元件,所述弹出元件能够在所述可致动元件从所述第一位置运动到所述第二位置时从所述指状元件中弹出所述植入物,从而从所述联接系统中释放所述植入物。
21、根据权利要求20所述的系统,其中,所述弹出元件基本上设置在所述可致动元件的远端处。
22、根据权利要求1所述的系统,其中,所述联接系统能够具有第一收缩输送结构和第二扩张结构。
23、根据权利要求22所述的系统,其中,所述多个指状元件包括能够限制所述联接系统扩张的约束装置。
24、根据权利要求23所述的系统,其中,所述约束装置穿过所述多个指状元件内的一组孔中的每一个孔,从而联接所述多个指状元件并限制所述多个指状元件的扩张。
25、根据权利要求1所述的系统,其中,所述医疗植入物包括可扩张的编织物。
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US8894703B2 (en) 2014-11-25
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