CN105473106A - 经心尖的植入物***、植入物和方法 - Google Patents
经心尖的植入物***、植入物和方法 Download PDFInfo
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Abstract
经心尖的植入物包括间隔件、杆体,和间隔件阀组件,所述间隔件限定间隔件腔,所述间隔件腔配置为从收缩位置扩张,所述杆体从所述间隔件延伸,所述杆体限定充胀管腔,所述充胀管腔流体联接到所述间隔件腔并配置为流体地联接到扩张介质源,所述间隔件阀组件置于所述间隔件或杆体中的至少一者内,所述间隔件阀组件构造为选择性地允许扩张介质流入到所述间隔件腔,以有选择地将述间隔件从收缩位置扩张到扩张位置。
Description
发明领域
本发明涉及功能失调的心脏瓣膜的修复和/或矫正,其更具体地涉及心脏瓣膜植入物和用于递送和实施心脏瓣膜植入物的***和方法。
发明背景
人的心脏有四个腔室,即,左心房和右心房,以及左心室和右心室。心脏的腔室交替扩张和收缩,以泵送血液通过身体的血管。心脏的循环包括左心房和右心房的同时收缩,将血液从心房传送到左心室和右心室。然后左心室和右心室同时收缩,迫使血液自心脏通过身体的血管。除了四个腔室之外,心脏还包括在每一个腔室的上游端的止回阀(瓣膜),以确保随着心脏腔室的扩展和收缩,血液以正确的方向流经身体。这些瓣膜可能受损坏,或以其它方式而无法正常工作,导致它们在下游腔室收缩时无法正确地关闭。瓣膜不能正常关闭可能使得血液经瓣膜回流,导致血流量减少和血压降低。
二尖瓣返流是心脏瓣膜功能不全或机能不全的常见变化形态。当将左冠状动脉和左心室分开的二尖瓣不能适当关闭时,发生二尖瓣返流。其结果是,当左心室收缩时,血液可能会从左心室漏回或流回到左心房,而不是被迫使通过主动脉。任何削弱或损害二尖瓣的疾病都可能阻止它适当闭合,从而导致渗漏或返流。当情况持续存在,而不是只在很短的时间内发生时,二尖瓣返流被认为是慢性的。
不管原因如何,二尖瓣返流可导致流经身体的血流量(心脏输出量)的降低。二尖瓣返流的矫正通常需要外科手术干预。外科手术的瓣膜修复或更换以心内直视术执行。修复或更换外科手术可能会持续约三到五小时,并且是在患者处于全身麻醉的条件下进行的。外科手术的性质需要将患者置于心肺机上。由于与心内直视外科手术过程相关的严重程度/复杂性/危险,通常不建议进行二尖瓣返流的矫正手术,除非患者的射血分数低于60%和/或左心室处于静止时大于45毫米。
在一些情况中,患有二尖瓣返流的患者也需要主动脉瓣的置换。有研究显示,例如,需要主动脉瓣置换的约30%的患者也有中度到重度的二尖瓣返流。通常情况下,这些患者只接受主动脉瓣置换,而二尖瓣返流没有被治疗。主动脉瓣置换的一种方法包括经心尖的主动脉瓣。经心尖的主动脉瓣置换可经由经心尖途径进行递送,其利用两个肋之间的短的切口(例如,3-4英寸长),以获得到左心室的心尖的通道。这有时被称为“微型开胸术”,并且相比于获得进入心脏的传统方法,侵入性要小得多;该传统方法即涉及开裂中间的胸骨和将胸部完全打开的正中胸骨切开术。
另一种常见的心脏病症包括冠状动脉疾病,其可以经由微型开胸手术通过冠状动脉旁路移植术(CABG)来治疗。有时候,这些患者也可以受益于伴随的二尖瓣修复。事实上,有时患者因冠状动脉堵塞而患有二尖瓣返流,且单独CABG不足以治疗二尖瓣返流。
因此,存在治疗二尖瓣返流、特别是使用经心尖途径治疗二尖瓣返流的需要。
附图说明
所要求保护的主题的特征和优点可从与其一致的实施方案的下述描述中获知,应当结合附图考虑该描述,其中:
图1是与本发明一致的二尖瓣植入物的一个实施方案的透视图;
图2大体地示出通过心尖***到左心室的针;
图3大体地示出通过针***到左心室的导丝;
图4大体地示出针被移出和在左心室中的导丝;
图5大体地示出***到左心室中的导引器和扩张器的一个实施方案。
图6大体地示出围绕所述导引器固定的荷包缝合线和纱布;
图7大体地示出导丝自所述导引器移除;
图8大体地示出部分超出导引器末梢的信使球囊的实施方案;
图9大体地示出在导引器末梢的被充胀的信使球囊;
图10大体地示出被推进通过二尖瓣的被充胀的信使球囊;
图11大体地示出在左心房中的被充胀的信使球囊。
图12大体地示出装载到导引器的植入物;
图13大体地示出在左心房中的植入物;
图14大体地示出在二尖瓣中的植入物;
图15大体地示出在填充之前处于收缩位置的植入物;
图16大体地示出在填充之后处于扩张位置的植入物;
图17大体地示出在填充之前处于收缩位置的间隔件阀组件的一个实施方案;
图18大体地示出在填充之后处于扩张位置的间隔件阀组件;
图19大体地示出在中间位置的间隔件阀组件;
图20大体地示出在填充之前处于收缩位置的充胀手柄组件的一个实施方案;
图21大体地示出在填充之后处于扩张位置的充胀手柄组件;
图22大体地示出在二尖瓣中的植入物、充胀手柄组件和***器;
图23大体地示出在已证实植入物在二尖瓣中之后,***导引器;
图24大体地示出在二尖瓣中的植入物,其中锚固组件行进到心尖;
图25-28示出锚固组件的一个实施方案的各种视图。
具体实施方式
通过概览的方式,在心脏内示出的经心尖的二尖瓣植入物10的一个实施方案的透视图大体示于图中。经心尖二尖瓣植入物10(以下简称为植入物10和/或二尖瓣植入物10)包括间隔件12、杆体14、和任选地锚固组件16。一般来说,二尖瓣植入物10递送到心脏1内并锚固于如图1中所大体示出的天然冠状组织2,使得间隔件12的至少部分贴近二尖瓣3布置,且二尖瓣植入物10可以与天然二尖瓣3的至少部分相互作用和/或协作,以减少和/或消除过度的返流。例如,当二尖瓣3处于关闭状态时,心脏1瓣膜的一个或多个尖瓣4的至少部分可以与心脏瓣膜植入物10的至少部分(例如,但不限于间隔件12)相互作用、接合、和/或抵接其密封。至少一个尖瓣4的至少部分和心脏瓣膜植入物10的至少部分之间的相互作用、接合和/或密封可以减少和/或消除心脏瓣膜3中的返流,该心脏瓣膜3例如在去除患病的和/或受损的尖瓣4之后,提供的密封不充分、仅包括单一的尖瓣4,和/或具有破裂的腱索(cordae)。与本发明一致的心脏瓣膜植入物10可以使用以针对附加和/或替代的各种缺陷和/或缺失。
如本文更详细地讨论的,二尖瓣植入物10通过经心尖途径而被递送到在左心室5和/或左心房6内的二尖瓣3。在两个肋骨之间形成短切口(例如,3-4英寸长),以获得通向左心室5的心尖8的通道。制作切口通过心尖8,以获得通向左心室5的通道。随后将二尖瓣植入物10引入到二尖瓣3中,扩张间隔件12,且在例如靠近心尖7的心脏1的外侧,将锚固件固定到心脏1的天然冠状组织2。
二尖瓣植入物10提供了许多益处。例如,可以安装二尖瓣植入物10以减少/防止在跳动的心脏(即没有移出患者的心脏和没有进行体外心肺循环(CPB)手术)上的二尖瓣返流。因此相比于正中胸骨切开术,经心尖的途径侵入性较小。此外,如上所述,许多患有二尖瓣返流的患者也患有使必需采用经心尖手术的其它病症。就此而言,根据本发明的二尖瓣植入物10允许二尖瓣返流的治疗而不需要显著侵入性手术(例如,二尖瓣植入物10可以在患者已经经历经心尖手术来处理其他医疗病症时被植入)。
参考图2,经心尖的***和方法包括获得通向左心室5的入口。例如,将空心针20(它可以联接到针座22)通过左心室5的心尖7***并进入到左心室5。一旦已经实现到左心室5的通道,引入导丝24通过空心针20的管腔而进入到左心室5,如图3中所大体示出的。导丝24可以包括1/32”的丝,并且在导丝24在左心室5中从空心针20出来后,导丝24可以任选地形成弯曲、猪尾形状。
在导丝24在左心室5中的情况下,将空心针20从心脏1除去,留下导丝24继续在左心室5中,如图4中所大体示出的。导丝24可被用作用于使其它设备或装置行进到心脏1中的途径。例如,导引器26和/或扩张器28可以沿导丝24行进到左心室5中,如图5中所大体示出的。
导引器26的杆体的远端30可以是倾斜的,以辅助导引器26穿过心尖7中的切口。导引器26还可以设有弯曲部27。预定的弯曲部27在导引器26的制造期间于导引器26中形成,并配置为便于导引器26的远端30与二尖瓣3对准。在没有弯曲部27(例如,如果导引器只是直线型的)的情况下,使导引器26的末梢30与二尖瓣3对齐、在两个***肌之间、以及进入到二尖瓣3的流出道将是非常困难的。尽管弯曲部/弧曲27看起来不是与二尖瓣3完美对齐,这是(部分地)由于在二维图中不容易显示三维路径。弯曲27可以设置成与导引器26的主要部分的纵轴成20-40度(例如30度)的角,所述导引器26的主要部分的纵轴从心尖7中的切口向外延伸。
导引器26可以任选地包括***器(也称为导引器座))32,***器32配置为纵向***导引器26的杆体,使得导引器26形成***式导管,所述***式导管容易地被移除,同时允许导引器26的管腔内的物体(例如,导丝24和/或植入物10的部分)仍留在导引器26的管腔内。***器32可以包括密封件,所述密封件配置为允许另外的装置和/或管腔被选择性且可拆卸地密封和/或行进通过***器32而进入到导引器26的管腔中。
例如,***器32(导引器座)可以包括至少两部分,即,以提供优先的和受控的可断开的接缝的方式模制的、由聚合物制成的外壳,和也具有模制的可断开接缝的、由硅酮橡胶制成的内密封件。外壳和硅酮密封机械地连接,使得可断开的接缝都沿着与导引器26的杆体/内管腔相同的轴线进行定位。***器32(导引器座)机械地连接到导引器的管状杆体的近端。当以足够的力、以相反的方向操纵***器32(导引器座)的外壳的“手柄”,朝向导引器26的远端旋转离开导引器26的轴线时,外壳的优先断开的接缝和***器32(导引器座)的内密封件的优先断开的接缝永久分开并在导引器26的管壁中传递裂缝。继续进一步分开***器32(导引器座)的手柄反过来又继续使裂缝在导引器26的管中行进。用户继续分开手柄,持续撕裂管,直到裂缝达到所述管的远端并完成导引器26的轴向分开。
一旦导引器26通过心尖7中的切口已经推进到左心室5中,一个或多个荷包缝合线和/或纱布34可以被固定到导引器26的杆体和切口周围,如图6中所大体示出的。荷包缝合线和/或纱布34被配置为在手术期间对导引器26的杆体施加径向压力,从而最小化意外撕裂靠近所述切口的心脏组织的可能性,并且还尽量减少在手术期间的失血。例如,一种或多种大尺寸缝线可以以连续的环在导引器26的杆体周围经过,因此,当它环绕四周时,缝线可被拉紧像套索或荷包绳一样将周围组织紧紧地保持在导引器26的周围。为了防止缝线撕裂开组织,每次缝线穿过组织时,所述缝线也穿过织造聚酯织物构成的小纱布。任选地,两个荷包缝合线(每个具有四个纱布)可以用于将导引器26固定至左心室壁。
扩张器28的一个实施方案可以包括限定至少一个管腔,所述管腔配置为接收递送的导丝24的至少部分。例如,所述管腔可具有大约0.038"的内径。扩张器28还可以包括杆体,所述杆体包括渐缩的末梢区域46。当扩张器28在导丝24上被引入时,渐缩的远端末梢46可以被提供为促进末梢46推进到心尖7中的穿刺部位中。所述杆体可以包括具有不同的刚度或硬度的多个部段或部分以产生所需的总体弧曲。所述杆体可以由一种或多种适合的聚合物,例如但不限于聚醚嵌段酰胺形成。所述杆体可以具有恒定的内径和/或外径并且可以由不同的材料制成,以提供不同的刚度或硬度。替代或补充地,所述杆体可以具有不同的内径和/或外径,并且可以由一种或多种材料制成。例如,可以通过在不同的部段或部分改变杆体的厚度来提供各种刚度或硬度的杆体。部段的不同硬度可以对扩张器28提供不同程度的弯曲刚度,这可有利于使扩张器28推进入和/或离开左心室3。
一旦导引器26被定位在左心室5,则导丝24可以被移除,留下导引器26和扩张器28在左心室5中,如图7中所大体示出的。由于预定的弯曲部27,导引器26和/或扩张器28的远端30大体与二尖瓣3对准。可以使塌瘪的信使球囊48行进通过导引器26和/或扩张器28的管腔,直至塌瘪的信使球囊的至少部分离开导引器26和/或扩张器28的远端30,如图8中所大体示出的(为清楚起见,在示出中扩张器28收缩到导引器26中)。信使球囊48的杆体50可以包括标记51,用于指示信使球囊48相对于导引器26的位置。例如,当标记(其可以包括覆盖杆体50的织物的近端)与***器32对齐和/或从***器32突出几毫米时,约1cm的信使球囊48为从导引器26的端部30突出。
当扩张时,使球囊48被配置为促进导引器26和/或扩张器28行进通过二尖瓣3而不损坏二尖瓣3或缠住在二尖瓣3(例如,二尖瓣3的尖瓣4、腱索和/或***肌8)。信使球囊48可以布置为接近杆体50的远端区域,并且可以通过杆体50而流体联接到扩张介质,诸如但不限于,气体和/或液体,所述扩张介质可自如图8中所大体示出的塌瘪的或收缩的位置扩张和/或扩大信使球囊48至充胀或扩张位置,如图9中所大体示出的(注意,信使球囊48只部分地从导引器26延伸)。信使球囊48形成柔软的末梢,该柔软的末梢用作防止损伤的“缓冲器”末梢,以最小化破坏或甚至刺激左心室5的娇嫩内层(心内膜)的风险。与左心室5的大量的接触可能导致危险性心律失常。根据至少一个实施方案,扩张介质可以包括二氧化碳CO2的气体和/或盐水。任选地,对比剂可被引入到信使球囊48,以允许信使球囊48使用荧光透视等更容易地在视觉上定位。对比剂可涂到信使球囊48的内表面。
信使球囊48可包括弹性可扩张/可塌缩的材料,例如,但不限于,硅酮、YulexTM或类似物,该可扩张/可塌缩的材料可被选择性地塌缩和/或充胀。信使球囊48可结合到杆体50,并且可以包括一个或多个通道、孔或管腔,以允许扩张介质扩张/收缩信使球囊48。在第一或收缩/塌缩位置时信使球囊48的直径应足够小,以在导丝24上行进通过导引器26和/或扩张器28到左心室5,且在第二或扩张/充胀位置时,信使球囊48的直径足够大,以行进通过二尖瓣3的尖瓣4和腱索8,以降低损坏心脏1和/或在二尖瓣3内缠结的可能性。例如杆体50可具有大约0.062"(例如,5Fr)的外径。在第一位置时,信使球囊48的直径可以为约0.100",在第二位置时,信使球囊48的直径可以为约15mm至约20mm,长度为约8mm至约10mm。
使信使球囊48朝向二尖瓣3行进,如图10中所大体示出的。如可以看到的,在导引器26中的弯曲27有助于使导引器26在空间上正确定向,以找到两个***肌之间的空间,并避开腱索。如以上所指出的,二维图的局限性并没有完全传达弯曲27的优点。随着信使球囊48接近二尖瓣3,信使球囊48可以行进通过二尖瓣3。来自左心室5的回流通过二尖瓣3进入左心房6(即使对于正常的二尖瓣)有助于将充胀的信使球囊48“拉”进入二尖瓣空间,使得信使球囊48可最终行进到左心房6中,如图11所大体示出的。导引器26与扩张器28然后可沿信使球囊48的杆体50而行进到左心房6中。
一旦导引器26已经通过二尖瓣3而行进到左心房6内,扩张器28、导丝24和信使球囊48可以从导引器26移除,且收缩/塌瘪的植入物10可被装载到导引器26(例如,通过***器32),如图12中所大体示出的。在将植入物10装载到导引器26之前,植入物10可被脱气。如果使来自植入物10的裹入气被引入到患者的心血管***,则空气可行进到患者的大脑或患者的身体的其它部分,在那里它可以引起严重的身体伤害和/或死亡(例如,由于血栓等)。为了对植入物10进行脱气,流体(诸如,但不限于,盐溶液等)可以通过充胀管腔66注入间隔件腔68,以在将植入物10***到导引器26之前冲去和/或去除任何裹入气。
如先前指出的,植入物10包括可扩张的间隔件12、杆体14、和锚固组件16。当植入物10装载到导引器26时,杆体14可具有比植入物10被固定到心脏1(例如,如图1中所示)时的杆体14长度明显更长的长度。例如,杆体14可以足够长,以允许外科医生在植入物10被布置在左心房6/二尖瓣3内时,从患者身体外部操纵植入物10。杆体14可以包括大体柔性的管,诸如,但不限于,限定管腔的聚(四氟乙烯)(PTFE)管。可选地,杆体14的外表面可包括织物护套等,所述织物护套等配置为防止血栓从杆体14脱落。杆体14也可以任选地包括一个或多个加强件(未示出),以对杆体14提供必要量的刚性,使得杆体14在安装时能够保持间隔件12相对于二尖瓣3的位置。加强件可以包括,例如,编织丝网或类似物。
根据一个实施方案,杆体14被固定到手柄组件54,且锚固组件16可设置为靠近手柄组件54。手柄组件54可被用于使植入物10行进通过导引器26直到植入物10的至少部分(如,收缩/塌瘪的间隔件12)在左心房6中突伸超过导引器26的远端30,如图13中所大体示出的。一旦间隔件12的部分突伸超过导引器26的远端30,导引器26可以略微缩回,以允许间隔件12的其余部分突伸超过远端30。间隔件12也可以利用手柄组件54被充胀,以及被从左心房6拉回并进入到二尖瓣3,如图14中所大体示出的。利用一个或多个标记物56(例如,在荧光透视下可见的不透射线的标记物)可以确定间隔件12在二尖瓣的环内的位置。导引器26的远端30现在布置在左心室5中。对比介质可以被注入到导引器26,至左心室5,以验证是否二尖瓣返流已经通过间隔件12的作用被显著减少,该间隔件12与二尖瓣3的尖瓣4接合。
现在转向图15和16,植入物10的间隔件阀组件60被大体示出在收缩位置(图15),其中间隔件12已准备好被扩张(即,准备接收扩张介质),和处于扩张位置(图16),其中,间隔件12已经被扩张并密封。间隔件阀组件60允许间隔件12被选择性扩张和/或消胀至期望的压力或刚度。间隔件12包括弹性的柔性壁62,该弹性的柔性壁62由生物学上可接受的材料制成,例如,Elast-EonTM材料等。
壁62的第一(近端)端部64被联接、安装或以其它方式固定到杆体14的部分。间隔件12可以包括第一充胀管腔66(1),其可以大体上沿着间隔件12的大体上整个纵向轴线或仅其部分延伸。第一充胀管腔66(1)流体联接到与杆体14相关联的第二充胀管腔66(2),并且被配置为允许扩张介质(诸如,但不限于,盐水等)从手柄组件54(例如,在图12中可以看到手柄组件54)进入到间隔件腔68。第一充胀管腔66(1)可以是间隔件12的组成部分和/或可以包括杆体14的延伸部分(例如,第一和第二充胀管腔66(1)、66(2)可以是相同的管腔的部分)。
间隔件腔68由第一充胀管腔66(1)和壁62所限定。间隔件12的第二(远端)端部70包括端塞72,端塞72被配置为将第一充胀管腔66(1)的第二部分的远端74与壁62密封。第一充胀管腔66(1)还包括多个孔76(1)-(n)。孔76(1)-(n)可沿着第一充胀管腔66(1)的长度布置并被配置为允许扩张介质从第一充胀管腔66(1)流入到间隔件腔62。第一充胀管腔66(1)可以包括第一组孔(如,孔76(1)、76(2))和/或第二组孔(例如,孔76(3)、76(n)),所述第一组孔设置为靠近间隔件12的第一端62,所述第二组孔设置为靠近间隔件12的第二端70。两组孔的使用允许更均匀地充胀间隔件腔68。
如本文所指出的,间隔件阀组件60被配置为允许外科医生选择性扩张/收缩间隔件12,并且更具体地是间隔件腔68。间隔件阀组件60可以设有柱塞80,柱塞80布置在第一和/或第二充胀管腔66(1)、66(2)内,其配置为选择性密封第一充胀管腔66(1)和/或孔76(1)-(n)并有选择地允许扩张介质流入和/或离开间隔件腔68。
参考图17-19,大体示出了柱塞80在第一和/或第二充胀管腔66(1)、66(2)内的各种位置。具体地,图17示出处于对应于图15的准备被扩张的收缩位置的柱塞80。图18示出处于对应于图16的扩张的、密封位置的柱塞80。图19示出在可选的、中间位置的柱塞80,在该位置间隔件腔68被选择性地、可移除地密封,使得间隔件腔68在二尖瓣3内的扩张可被验证。该中间位置允许外科医生选择地密封和解封柱塞80,使得外科医生可以基于二尖瓣3内的植入物10的性能而有选择地扩张和/或收缩间隔件腔68。
柱塞80联接到柱塞线82。柱塞线82延伸穿过间隔件12的充胀管腔66(1)、66(2)和/或杆体14,且可联接到如本文所述的充胀手柄组件。柱塞线82允许外科医生在第一和/或第二充胀管腔66(1)、66(2)内移动柱塞到任何充胀/密封位置。柱塞线82可以可移除地联接到柱塞线82,例如,使用螺纹连接84等。
参照图17,柱塞80处于准备扩张的扩张位置,且孔76(1)-(n)被流体地联接到第一和第二充胀管腔66(1)、66(2)。柱塞80可以被布置在第一充胀管腔66(1)内第一组孔76(1)、76(2)和第二组孔76(3)、76(n)之间。因为第一组孔76(1)、76(2)在柱塞80的上游,第一组孔76(1)、76(2)流体联接到充胀管腔66(1)。第一充胀管腔66(1)可具有渐缩的内径,其沿间隔件12的纵向轴线从第一端或近端64朝向间隔件12的第二端或远端70扩张。第一充胀管腔66(1)的横截面(例如,直径)的至少部分大于柱塞80的横截面(例如,直径),使得流体可以流动通过柱塞80,从而将第二组孔76(3)、76(n)流体联接到充胀管腔66(1)。
现在转向图18,柱塞80处于收缩/密封位置,在该位置,孔76(1)-(n)自第一和第二充胀管腔66(1)、66(2)被流体地密封。柱塞80可设置在第一和第二组孔76(l)-(n)上游的第一或第二充胀管腔66(1)、66(2)内并与其一起密封。这样,没有扩张介质可以流入或流出孔76(1)-(n),所述间隔件腔68被密封。为清楚起见,柱塞80将被描述为与第二充胀管腔66(2)进行密封,然而,应该理解的是,柱塞80可以与第一和/或第二充胀管腔66(1)、66(2)中的任一者进行密封。
柱塞80可具有渐缩部84(例如,大致圆柱形的渐缩部),其被配置为与第二充胀管腔66(2)的相应的渐缩部86(大致圆柱形的渐缩部)创建摩擦连接(例如,莫氏锥度等)以密封第二充胀管腔66(2),并最终密封间隔件腔68。柱塞80也可以与第二充胀管腔66(2)形成螺纹连接以密封第二充胀管腔66(2),并最终密间隔件腔68。柱塞80与第二充胀管腔66(2)密封的替代性实施方案也是可以的。
图19示出在可选的中间位置的柱塞80。当柱塞80处于中间位置时,外科医生可以有选择地密封和启封间隔件腔68,以允许间隔件12被进一步扩张或收缩。当验证间隔件12在二尖瓣3内的性能时,可以使用该中间位置。为了密封间隔件腔68,柱塞80被推向远侧,使得柱塞80的部分在孔76(l)-(n)的上游的位置对渐缩充胀管腔66(1)、66(2)进行密封。为了对间隔件腔68进行解封(例如,在该外科医生想要从间隔件腔68释放一些扩张介质来减少间隔件12的总体尺寸的情况下),外科医生向近侧推动柱塞80。充胀管腔66(1)、66(2)的增加的锥度允许扩张介质流过柱塞80从而将孔76(1)-(n)流体联接到充胀管腔66(1)、66(2)。以这种方式,基于植入物10在二尖瓣3内的性能,外科医生可以容易地调整间隔件12的尺寸。
应该理解,柱塞80的渐缩部86的取向和充胀管腔66的渐缩部88的取向可以被切换。切换渐缩部86、88的取向,将使得在相反的方向上推动柱塞80,以密封和解封间隔件腔68。
现在转向图20和21,充胀手柄组件90的一个实施方案被大体示出。杆体14的近端92可被固定(永久地或可拆卸地固定)到充胀手柄组件90的一部分。例如,利用一个或多个密封件94,杆体14可以被气密密封并联接到充胀手柄组件90。充胀手柄组件90的主体96包括充胀口98,充胀口98流体地联接到杆体14的充胀管腔66(2)。充胀口98被配置为固定到充胀源(例如,但不限于,一个柱塞/注射器等,未示出),所述充胀源用于对如本文所述的间隔件腔68提供扩张介质。
柱塞线82从杆体14的充胀管腔66(2)延伸,并穿过充胀手柄组件96的主体96。当柱塞线82穿过主体96时,可以提供一个或多个密封件99来密封主体96至柱塞线82。柱塞线82的近端任选固定到位移机构100。位移机构100(其可包括环、滑块、球形手把等)可以被配置为相对于主体96移动以在充胀管腔66(1)、66(2)内推或拉柱塞线82。例如,当位移机构100处于图20中所示的位置时,柱塞80可被布置在充胀位置,如图15和17中所大体示出的。当位移机构100处于图21中所示的位置时,柱塞80可被布置在扩张、密封位置,如图16和18中所大体示出的。当位移机构100处于图20和图21之间的位置时,柱塞80可以布置在中间位置,如图19中所大体示出的。
充胀手柄组件90可任选地包括一种或多种手柄结构102,手柄结构102从主体96延伸,被配置为便于用一只手操作充胀手柄组件90。例如,充胀手柄组件90可以包括两个手柄结构102,该两个手柄结构102布置在主体96的大致相对侧,其各自被配置为接收用户的手指中的不同的一个(例如,分别为食指和中指)。位移机构100可以设有配置成接收用户的拇指的环。采用这种布置,外科医生可以用单手抓住充胀手柄组件90并来回平移位移机构100,以来回推动柱塞线82(以及最终推动柱塞68),以选择性密封和解封间隔件腔68。这种布置允许外科医生使用外科医生的另一只手来控制扩张介质源。
现在转向图22,在心脏1内的具有间隔件12的植入物10被示出。植入物10的杆体14被设置在导引器26(例如,***式导管)内,并联接到充胀手柄组件90。示出的锚固件16设置为靠近充胀手柄组件90。充胀口98流体联接到扩张介质源104(例如,柱塞/注射器)。外科医生可以使用充胀手柄组件90来操纵植入物10,使得间隔件12被设置在二尖瓣3内。利用充胀手柄组件90和扩张介质源膨104,间隔件12还可以被扩张到所需的尺寸。一旦间隔件12的所需的尺寸被确定,使用充胀手柄组件90可以密封间隔件12。
在间隔件12的操作已经被验证、且该间隔件已被密封后,可以将导引器26从杆体14移除,例如,如图23中所大体示出的。例如,***器32可以用于将导引器26沿其长度分成两个或更多个部件106(1)、106(2),例如,通过大致沿箭头110(1)、110(2)的方向拉动两个半部108(1)、108(2)。当导引器26被***时,导引器26可以从心脏1中缩回通过心尖7中的切口。当导引器26从心尖7中的切口移除时,荷包缝合线34(为清楚起见未示出)也可以被拉紧,以尽量减少失血。一旦导引器26已经从杆体14中移除,锚固组件16可沿着杆体14被推进,直到锚固组件16邻近和/或紧靠心脏1的心尖7,例如如图24中所大体示出的。另外,柱塞线82可以从柱塞80脱开,例如,通过旋转位移机构100从柱塞80拧脱柱塞线82。
现在转向图25-28,锚固组件16的一个实施方案的各种视图被大体示出。锚固组件16(如图26中所最清楚显示的,图26是沿图27的B-B线所取的剖视图)包括夹紧环112、套环114、螺母116、锚固支撑件118、以及任选的毡垫120。锚固组件16限定延伸通过其的通道122,通道122被配置为接收植入物10的杆体14并在该杆体14上行进。夹紧环112、套环114、和螺母116被配制为限定围绕杆体14周边的压紧接头,从而将锚固组件16固定到杆体14。尤其是,一旦锚固组件16就位(例如,紧靠靠近心尖7的切口部位周围的组织),外科医生握住锚固支撑件118,同时旋转螺母116,从而压紧夹紧环112和套环114以对杆体14施加径向压力。该径向压力将锚固组件16固定到杆体14。为了说明的目的,锚固支撑件118可以具有0.875cm的长度L和0.030cm的厚度T,且通道122可具有0.116cm的直径D。
为了将锚固组件16固定到心脏1,可以将锚固支撑件118缝合到心脏组织。锚固支撑件118可包括一个或多个开口124和/或臂126,沿着其可以使一根或多根缝线(为清楚起见未示出)穿过,以将锚固支撑件118缝合到心脏组织中,并固定锚固组件16。锚固支撑件118的安装表面128可以具有曲率,该曲率大致上对应于围绕心尖7的切口部位附近的心脏组织的曲率。锚固支撑件118可以任选地包覆/覆盖/包裹有纱布材料。纱布材料促进组织在锚固支撑件118之上生长,从而进一步提高锚固组件16和心脏1之间的连接。
其它锚固组件也可用于将植入物10固定到心脏1。例如,一个或多个叉,倒钩、钉、夹具、和/或螺钉可以用于固定植入物10到心脏。此外,锚固组件16可以被省去。例如,可以使用杆体14而将植入物10固定到心脏,该杆体14可以卷曲并利用例如缝线、U形钉等固定到心脏1。
现在参考图1,固定到心脏1的植入物10被示出。一旦锚固组件16被固定到心脏1,杆体14可以在锚固组件16附近被切割。当安装时,间隔件12被配置为与天然二尖瓣3的至少部分(例如,尖瓣4)相互作用和/或协作(例如,接合),以减少和/或消除过度返流。这样,间隔件12的构造和/或几何形状可取决于患者的二尖瓣3的病症和对其损害的具体情况。另外,植入物10(例如,间隔件12和/或杆体14)具有足够的整体刚度,以保持间隔件12在二尖瓣3内,使得植入物10如预期中的运行。
根据一个方面,本发明的特征为经心尖植入物。所述植入物包括间隔件、杆体和间隔件阀组件,所述间隔件限定间隔件腔,所述间隔件腔配置为从收缩位置扩张,所述杆体从所述间隔件延伸,所述杆体限定充胀管腔,所述充胀管腔流体联接到所述间隔件腔并配置为流体联接到扩张介质源,所述间隔件阀组件置于所述间隔件或杆体中的至少一者内,所述间隔件阀组件构造为选择性地允许扩张介质流入到所述间隔件腔,以有选择地将述间隔件从收缩位置扩张到扩张位置。
根据另一个方面,本发明的特征为植入物递送***。所述植入物递送***包括导引器和植入物,所述导引器具有至少一个管腔。所述植入物配置为被容置在所述管腔内,并包括间隔件和杆体。当所述间隔件限定间隔件腔,所述间隔件腔构造成当布置于所述导引器的管腔内时从收缩位置扩张。所述杆体配置为从所述间隔件延伸并限定充胀管腔,所述充胀管腔流体联接到所述间隔件腔,并配置为流体联接到扩张介质源。
根据又另一方面,本发明的特征为经心尖地递送心脏内的植入物的方法,所述植入物包括杆体和间隔件,所述间隔件配置为与二尖瓣中的至少一个尖瓣的至少部分相互作用,以至少部分地限制血液流动通过在闭合位置的心脏瓣膜。所述方法包括:使导引器经心尖地行进通过所述心脏的心尖中的切口到左心室;使所述导引器行进通过所述二尖瓣至左心房;使所述植入物行进通过所述导引器所限定的管腔至左心房,其中所述杆体在所述管腔内从所述间隔件延伸并延伸超过在心脏内的切口;通过所述杆体引入扩张介质,以扩张所述间隔件;将所述间隔件安置于所述二尖瓣内,以减少二尖瓣返流;从所述心脏移除所述导引器;和将所述植入物固定到靠近心尖的心脏的外表面。
如上所述,本发明并不打算限定于必须满足本发明内容的任何规定的或暗示的目标或特征中一个或多个的***或方法,且不应被限制于本文所描述的优选的、示例性的、或主要的实施方案。为了进行说明和描述的目的,已提供了本发明的优选实施方案的前述描述。它没有试图穷尽或限制本发明至所公开的精确形式。根据上述教导,可以进行明显的修改或变化。实施方案被选择和描述以提供对本发明的原理和它的实际应用的最好的说明,由此使本领域普通技术人员能够将本发明用在各种实施方案中且具有适合于特定预期用途的各种修改。所有这些修改和变化落在根据它们所被公平、合法和公正地赋予的宽度进行解释的权利要求书所限定的本发明的范围内。
Claims (20)
1.植入物,所述植入物包括:
间隔件,所述间隔件限定间隔件腔,所述间隔件腔配置为可从收缩位置扩张;
杆体,所述杆体从所述间隔件延伸,所述杆体限定充胀管腔,所述充胀管腔流体联接到所述间隔件腔并配置为可流体联接到扩张介质源;和
间隔件阀组件,所述间隔件阀组件置于所述间隔件或杆体中的至少一者内,所述间隔件阀组件构造为选择性地允许扩张介质流入到所述间隔件腔,以选择性地将述间隔件从收缩位置扩张到扩张位置。
2.如权利要求1所述的植入物,所述植入物还包括锚固组件,所述锚固组件配置成在所述杆体上行进并固定到其一部分,所述锚固组件进一步配置为固定到患者心脏的外表面。
3.如权利要求2所述的植入物,其中所述锚固组件包括压紧连接机构,所述压紧连接机构配置为对所述杆体施加径向压力,以将所述锚固组件固定到所述杆体。
4.如权利要求3所述的植入物,其中所述锚固组件还包括锚固支撑件,所述锚固支撑件限定至少一个臂,缝线沿着所述臂被缝合。
5.如权利要求1所述的植入物递送***,其中所述间隔件阀组件还包括柱塞,所述柱塞配置成可滑动地布置在所述充胀管腔内,其中当所述柱塞处于第一位置时,其被配置为允许扩张介质流入所述间隔件腔,且其中当所述柱塞处于第二位置时,其被配置为密封所述间隔件腔。
6.如权利要求5所述的植入物,其中所述充胀管腔的一部分包括渐缩部,所述渐缩部沿其长度而缩减,其中根据所述柱塞被配置成基于该柱塞相对于所述渐缩部的位置对所述充胀管腔选择性地进行密封和解封。
7.如权利要求5所述的植入物,其中柱塞被联接到柱塞线,所述柱塞线延伸通过所述杆体内的充胀管腔并延伸超出所述杆体的近端,其中所述柱塞线配置为选择性地在所述充胀管腔内移动所述柱塞。
8.根据权利要求7所述的植入物,其中柱塞线螺纹联接到所述柱塞。
9.植入物递送***,所述***包括:
导引器,所述导引器包括至少一个管腔;和
植入物,所述植入物配置为被容置在所述管腔内,所述植入物包括间隔件和杆体,其中,当所述间隔件限定出间隔件腔,所述间隔件腔配置成当间隔件布置于所述导引器的管腔内时可从收缩位置扩张,且其中所述杆体从所述间隔件延伸并限定充胀管腔,所述充胀管腔流体联接到所述间隔件腔并配置为可流体联接到扩张介质源。
10.如权利要求9所述的植入物递送***,所述***还包括锚固组件,所述锚固组件配置成沿所述杆体行进并固定到其一部分,所述锚固组件进一步配置为固定到患者心脏的外表面。
11.如权利要求10所述的植入物递送***,其中所述锚固组件包括压紧连接机构,所述压紧连接机构配置为可对所述杆体施加径向压力,以将所述锚固组件固定到所述杆体。
12.如权利要求11所述的植入物递送***,其中所述锚固组件还包括锚固支撑件,所述锚固支撑件限定至少一个臂,缝线沿着所述臂被缝合。
13.如权利要求9所述的植入物递送***,其中所述植入物进一步包括间隔件阀组件,所述间隔件阀组件配置为允许所述间隔件腔被选择性地扩张。
14.如权利要求13所述的植入物递送***,其中所述间隔件阀组件还包括柱塞,所述柱塞配置成可滑动地布置在所述充胀管腔内,其中当所述柱塞处于第一位置时,其被配置为允许扩张介质流入所述间隔件腔,且其中当所述柱塞处于第二位置时,其被配置为密封所述间隔件腔。
15.如权利要求14所述的植入物递送***,其中所述充胀管腔的一部分包括渐缩部,所述渐缩部沿其长度缩减,其中所述柱塞被配置成基于该柱塞相对于渐缩部的位置对所述充胀管腔选择性地进行密封和解封。
16.如权利要求14所述的植入物递送***,其中柱塞被联接到柱塞线,所述柱塞线延伸通过杆体内的所述充胀管腔并延伸超出所述杆体的近端,其中所述柱塞线被配置为选择性地在所述充胀管腔内移动所述柱塞。
17.如权利要求16所述植入物递送***,其中柱塞线螺纹联接到所述柱塞。
18.经心尖地递送心脏内的植入物的方法,所述植入物包括杆体和间隔件,所述间隔件配置为与二尖瓣中的至少一个尖瓣的至少一部分相互作用,以至少部分地限制血液流动通过在闭合位置的心脏瓣膜,所述方法包括。
使导引器经心尖地通过所述心脏的心尖中的切口行进到左心室;
使所述导引器通过所述二尖瓣行进至左心房中;
使所述植入物通过所述导引器所限定的管腔行进至左心房中,其中所述杆体在所述管腔内从所述间隔件延伸并延伸超过在所述心脏内的所述切口;
通过所述杆体引入扩张介质,以扩张所述间隔件;
将所述间隔件安置于所述二尖瓣内,以减少二尖瓣返流;
从所述心脏移除所述导引器;和
将所述植入物固定到靠近所述心尖的所述心脏的外表面。
19.如权利要求18所述的方法,所述方法进一步包括:
使锚固组件沿所述杆体行进,直到所述锚固组件抵接所述心脏的所述外表面;和
缝合所述锚固组件到所述心尖附近的组织。
20.根据权利要求18所述的方法,其中通过所述杆体引入所述扩张介质以扩张所述间隔件包括:选择性移动布置在所述间隔件或所述杆体中的至少一者内的柱塞,以选择性密封所述间隔件。
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CN109922758B (zh) * | 2016-11-09 | 2022-06-28 | 美敦力瓦斯科尔勒公司 | 与瓣膜假体递送***一起使用的腱索管理装置及使用方法 |
CN111374798A (zh) * | 2018-12-27 | 2020-07-07 | 先健科技(深圳)有限公司 | 介入引导装置 |
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WO2014152306A1 (en) | 2014-09-25 |
KR20150133781A (ko) | 2015-11-30 |
JP6546906B2 (ja) | 2019-07-17 |
CN105473106B (zh) | 2017-11-24 |
US9232998B2 (en) | 2016-01-12 |
EP2967865A1 (en) | 2016-01-20 |
EP2967865B1 (en) | 2019-03-13 |
US20140277404A1 (en) | 2014-09-18 |
JP2016512721A (ja) | 2016-05-09 |
US9833316B2 (en) | 2017-12-05 |
EP2967865A4 (en) | 2016-11-09 |
AU2014239939A1 (en) | 2015-11-05 |
CA2906636A1 (en) | 2014-09-25 |
US20160089237A1 (en) | 2016-03-31 |
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