CN102458309A - 整体式快速连接人工心脏瓣膜和展开系统与方法 - Google Patents
整体式快速连接人工心脏瓣膜和展开系统与方法 Download PDFInfo
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Abstract
本发明提供了一种在手术过程期间可以快速且容易地植入的快速连接心脏瓣膜假体。该心脏瓣膜包括基本不可扩张的、不可收缩的假体瓣膜和可塑性扩张的联接支架,因而能够连接瓣环而无需缝合。可以为主动脉瓣定向提供少量的缝合线。该假体瓣膜可以是具有缝合环的商售的瓣膜,其中具有连接到缝合环的联接支架。该联接支架可以从圆锥形展开形状扩张为圆锥形扩张形状,并且可以包括连接在轴向延伸的柱子之间的网状撑杆。用于展开的系统和方法包括中空的两件式手柄,球囊导管穿过该手柄。瓣膜支托物与心脏瓣膜一起存储,并且手柄容易地连接到该支托物上,从而改进瓣膜准备步骤。
Description
相关申请
本申请要求于2009年6月26日提交的美国临时申请号61/220,968的优先权,其整个内容以参考方式包括进本发明。
技术领域
本发明一般涉及用于植入人体通道的人工瓣膜。更具体地,本发明涉及整体式人工心脏瓣膜,其被构造为以比现有瓣膜的植入时间更少的时间被手术植入。
背景技术
在脊椎动物中,如图1所示,心脏是具有四个脉动腔室的中空的肌肉器官,所述四个脉动腔室即左心房和右心房与左心室和右心室,每个均有自身的单向瓣膜。天然心脏瓣膜被认为是主动脉的、僧帽瓣的(或二尖瓣的)、三尖瓣的和肺状的,每一个均固定在包含致密纤维环的瓣环上,该致密纤维环被直接或间接地附接到心房肌肉纤维和心室肌肉纤维。每个瓣环均限定流量孔口。
心房是血液接收室,其将血液抽吸到心室。心室是血液排出室。由纤维和肌肉部分组成的被称作的心房中隔的壁将右心房和左心房分隔开(参考图2到图4)。与心脏的更脆弱的肌肉组织相比较,纤维心房中隔是实质上更坚固的组织结构。心房中隔上的解剖学标志是椭圆形的拇指指纹大小的凹陷,被称为卵形圆窝或卵圆窝(如图4中所示)。
心脏的左侧和右侧的同步抽吸作用构成心动周期。该周期开始于心室松弛期,称作心室舒张。该循环结束于心室收缩期,称作心室收缩。四个瓣膜(参考图2和图3)确保在心动周期期间血液不会朝着错误的方向流动;即,从而确保血液不会从心室回流到相应的心房,或是从心房回流到相应的心室。二尖瓣在左心房和左心室之间,三尖瓣在右心房和右心室之间,肺动脉瓣在肺动脉的开口处,并且主动脉瓣在主动脉的开口处。
图2和图3示出了二尖瓣环的前部(A)部分,其邻接主动脉瓣的非冠状瓣叶。二尖瓣环在左边冠状动脉的旋支附近,且后部(P)侧面在冠状窦和其属支附近。
二尖瓣和三尖瓣均是由骨胶原的纤维环限定,每个均称为环/瓣环,其构成心脏的纤维骨架的一部分。环为二尖瓣的两个尖瓣或两个瓣叶(被称为前尖瓣和后尖瓣)和三尖瓣的三个尖瓣或三个瓣叶提供了围边附接。瓣叶的自由边缘连接到来自多于一个乳头肌的腱索,如图1所示。在健康的心脏中,这些肌肉和其腱索支撑二尖瓣和三尖瓣,使得瓣叶能够抵抗在左心室和右心室的收缩(抽吸)期间形成的高压。
在通过来自于左心房的血填充之后,当左心室收缩时,心室壁向内运动并且从乳头肌和腱释放一些张力。用力推向二尖瓣瓣叶的下表面的血液使得二尖瓣瓣叶朝着二尖瓣的瓣环平面上升。当朝着瓣环前进,前瓣叶和后瓣叶的前导边缘会合,形成密封并闭合瓣膜。在健康的心脏中,在二尖瓣环平面附近存在瓣叶接合。在左心室中继续对血液施加压力,直到血液喷射进主动脉中。乳头肌的收缩与心室收缩同步,并用来使健康的瓣膜瓣叶在由心室施加的峰值收缩压力处紧紧地关闭。
各种外科技术可以用于修复病变或已损伤的瓣膜。在瓣膜置换手术中,切除已损伤的瓣叶,并塑造瓣环用于接收置换瓣膜。由于主动脉瓣狭窄和其他心脏瓣膜疾病,每年无数病人经受手术,其中由生物假体的或机械的人工瓣膜来置换有缺陷的天然心脏瓣膜。另一种稍不激烈的用于治疗有缺陷的瓣膜的方法是通过修复或重构,一般用于最低限度钙化的瓣膜。外科治疗的问题在于,在存在与外科修复相关联的高发病率和死亡率的情况下,其将重要的损伤强加于这些慢性病病人。
当更换瓣膜时,人工瓣膜的外科植入一般需要开胸手术,在手术期间,心脏会停止且病人置于心肺分流(所谓的“人工心肺机”)。在一种常见的手术过程中,切除病变的天然心脏瓣叶,并且在瓣膜瓣环处将人工瓣膜缝合到周围组织。由于与过程相关联的外伤和体外血液循环的伴随持续时间的问题,某些病人不能从手术过程生还或是之后会很快死亡。众所周知,对病人而言风险随着心肺分流所需的时间量而增加。由于这些风险,大量具有缺陷瓣膜的病人被认为是不能动手术的,因为他们的状况太虚弱而无法承受手术过程。据某些估计,大约30%到50%的超过80岁的正在遭受主动脉瓣狭窄的对象无法进行主动脉瓣置换手术。
由于与传统的开胸手术相关联的缺点,所以强烈关注经皮的、微创手术方法。在一种技术中,人工瓣膜构造为通过导管插入术以微创过程被植入。例如,Andersen等人的美国专利号5,411,552描述了通过导管以压缩状态经皮引入且通过球囊膨胀在期望位置扩张的可折叠瓣膜。尽管对于治疗特定的病人这些远程植入技术已经大有希望,但是通过手术干预来更换瓣膜仍是优选的治疗过程。接受远程植入的一个障碍是来自医生的阻力,可以理解,医生对于从有效但不完美的控制转变为承诺有很好的结果但相对陌生的新方法的担心。结合可理解的外科医生对于转变到新式心脏瓣膜置换技术的慎重考虑,世界各地的监管机构也正在缓慢地前行。许多成功的临床试验和后续工作均在进行中,但是在新技术被完全接受之前需要更多关于这些新技术的经验。
因此,需要改进的设备和相关使用方法,其中人工瓣膜能够以更加有效的过程被外科植入到人体通道中,以减少心肺分流所需的时间。希望这种设备和方法能够帮助因而其状况太虚弱无法承受过长的手术过程而被认为不宜动手术的且具有有缺陷瓣膜的病人。
而且,外科医生说,当尝试微创心脏瓣膜植入或通过小切口植入时,最困难的任务之一是使缝合线打结,从而使瓣膜就位。典型主动脉瓣植入物利用围绕缝合环均匀分布且手动系在缝合环一侧上的12-24个缝合线(一般地15个)。直接在连合柱之后的结由于空间约束均是特别复杂的。消除对缝合线打结的需求或甚至将打结数减少为更易获得的结数将大大地促进使用更小的切口,降低了感染风险,减少了对输血的需求,并且提供了与通过常用于心脏瓣膜植入的完全胸骨切开术植入瓣膜的病人相比更加快速的恢复。
本发明解决这些需求和其他需求。
发明内容
本发明的各种实施例提供了人工瓣膜和用于置换人类心脏中的有缺陷的天然瓣膜的方法。某些实施例特别适用于快速且容易地置换心脏瓣膜同时最少化利用心肺分流(例如,分流泵送)的时间的手术过程。
在一种实施例中,一种用于处理人类心脏中的天然主动脉瓣,从而代替主动脉瓣功能的方法,该方法包含:1)通过胸腔的开口通达到天然瓣膜;2)将导向缝合线放在瓣环内;3)使心脏瓣膜在瓣环的内腔内前进;和4)塑性扩张在心脏瓣膜上的金属联接支架,从而以快速且高效的方式机械地联接到瓣环。
在输送人工瓣膜之前可以移除天然瓣膜瓣叶。或者,天然的瓣叶可以留在合适的位置,从而减少手术时间且提供用于将联接支架固定在天然瓣膜内的稳定底部。在该方法的一个优势中,天然瓣叶向内弹回,从而增强金属联接支架在人体通道中的固定。当天然瓣叶留在合适的位置时,球囊或其它扩张构件可以用于推开瓣膜瓣叶且因而在植入联接支架之前扩张天然瓣膜。天然瓣环可以从其最初孔口尺寸扩大1.0mm-5mm,从而适应更大尺寸的人工瓣膜。
根据优选的方面,心脏瓣膜包括限定其内的不可扩张、不可收缩的孔口的人工瓣膜以及从其入流端延伸的可扩张的联接支架。联接支架具有用于输送到植入位置的收缩状态和被构造为向外连接到底部支架的扩张状态。理想地,联接支架是可塑性扩张的。
在另一个方面中,用于在心脏瓣膜瓣环处植入的人工心脏瓣膜,包含:
a.限定了流动孔口的不可扩张、不可收缩的瓣环支撑结构,该支撑结构包括沿流出方向突出的多个连合柱;
b.柔性瓣叶,其附接到所述支撑结构和连合柱并被固定成在流动孔口之上交替地打开和关闭。
c.缝合可渗透环,其界定支撑结构的入流端;和
d.塑性-可扩张的联接支架,其具有围绕支撑结构的入流端延伸且被连接在该入流端处的第一末端,该联接支架具有第二末端,该第二末端背离瓣膜支撑结构沿入流方向突出并且能够呈现用于输送至植入位置的收缩状态和比第一末端更宽以向外接触瓣环的扩张状态。
在一种实施例中,心脏瓣膜包含具有缝合环的商售人工瓣膜,且联接支架附接到该缝合环。该联接支架的收缩状态可以是圆锥形的、朝着远端方向逐渐变细。该联接支架优选地包含多个径向可扩张撑杆,至少某些所述撑杆排列成行,其中最远一行具有从收缩状态向扩张状态的最大扩张能力。
此处也公开了输送和植入人工心脏瓣膜系统的方法,该方法包含以下步骤:
提供包括具有不可扩张、不可收缩的孔口的人工瓣膜的心脏瓣膜,该心脏瓣膜进一步包括从其入流端延伸的可扩张的联接支架,该联接支架具有用于输送至植入位置的收缩状态和构造为向外附接到瓣环的扩张状态;
使得具有处于其收缩状态的联接支架的心脏瓣膜前进至邻近瓣环的植入位置;和
将联接支架塑性扩张至与瓣环接触并连接到该瓣环的扩张状态。
该方法的一种实施例进一步包括将心脏瓣膜固定在具有近毂和通过其中的内腔的支托物上。该支托物安装在其中具有内腔的手柄的远端,以及该方法包括使球囊导管穿过手柄和支托物的内腔并进入心脏瓣膜内,和使球囊导管上的球囊膨胀从而扩张联接支架。可以将安装在支托物上的心脏瓣膜独立于手柄和球囊导管被封装。理想地,联接支架的收缩状态是圆锥形的,并且球囊导管上的球囊具有比其扩张近端更大的扩张远端,以便于向联接支架施加的扩张偏转大于向人工瓣膜施加的。
在联接支架是圆锥形的方法中,联接支架可以包含多个可径向扩张撑杆,至少某些所述撑杆排列成行,其中离人工瓣膜最远的一行具有从收缩状态向扩张状态的最大扩张能力。
该方法可以使用具有多个径向可扩张撑杆的联接支架,其中离人工瓣膜最远的一行具有交替的峰和谷。因此该联接支架的远端比联接支架的剩余部分扩张得更多,因此最远离人工瓣膜的一行中的峰向外突出到底部支架中的孔内。
此处所描述的另一方面是用于输送心脏瓣膜的系统,该心脏瓣膜包括具有不可扩张、不可收缩的孔口的人工瓣膜以及从其入流端延伸的可扩张的联接支架,该联接支架具有用于输送至植入位置的收缩状态以及扩张状态。该输送系统包括连接到心脏瓣膜的近端的瓣膜支托物、具有球囊的球囊导管以及被构造为附接瓣膜支托物的近端且具有用于导管通过的内腔的手柄,其中球囊向远端延伸穿过手柄、经过支托物并穿过心脏瓣膜。在该系统中,人工瓣膜是优选地具有缝合环的商售瓣膜,其中联接支架附接到该缝合环。
该输送系统中的联接支架的收缩状态可以是圆锥形的、朝着远端方向逐渐变细。而且,球囊导管可以进一步包括在其远端上的大体锥形头部圆锥体,其贯穿心脏瓣膜并接合处于收缩状态的联接支架的远端。理想地,手柄包含可以串联联接在一起从而形成连续内腔的近端部分和远端部分,其中远端部分适于联接到支托物的毂,从而使得能够利用远端部分在与近端手柄部分连接之前手动操作心脏瓣膜。在一种实施例中,球囊导管和近端手柄部分与在近端部分内腔内的球囊被封装在一起。可替代地,独立于手柄和球囊导管来封装被安装在支托物上的心脏瓣膜。
特别地当结合附图考虑时,权利要求和下面的说明书中陈述本发明的性质和优势的进一步理解,在附图中相似的零件具有相似的参考数字。
附图说明
现在将说明本发明,且参考示意性附图将理解本发明的其他优势和特征。在附图中:
图1是人类心脏的解剖前视图,其中一部分被剖视且以截面示出,从而观察内部心脏腔室和邻近的结构;
图2是人类心脏中的一部分的解剖上视图,示出了右心房中的三尖瓣、左心房中的二尖瓣以及在其间的主动脉瓣,其中在心动周期的心室舒张(心室充盈)期间,三尖瓣和二尖瓣打开而主动脉瓣和肺动脉瓣关闭;
图3是图2中所示的一部分人类心脏的解剖上视图,其中在心动周期的心室收缩(心室排空)期间,三尖瓣和二尖瓣关闭而主动脉瓣和肺动脉瓣打开;
图4是左心房和右心房的解剖学前透视图,其中一部分被剖视且以截面示出从而示出心脏腔室的内部和相关结构,例如卵圆窝、冠状窦和心大静脉;
图5A-图5E是通过隔离的主动脉瓣环的剖视图,其示出了在升主动脉以下的一部分相邻左心室,示出了此处所公开的示例性整体式人工心脏瓣膜的无缝合展开中的许多步骤,即:
图5A示出了安装在球囊导管上的整体式人工心脏瓣膜,其前进到主动脉瓣环内的位置;
图5B示出了在主动脉瓣环处在期望植入位置的整体式人工心脏瓣膜,其中球囊导管前进得更远,从而使得头部圆锥体移动脱离与联接支架的接合;
图5C示出了导管上的球囊,其被膨胀从而扩张且抵靠主动脉瓣环并在其下方展开扩口式联接支架;
图5D示出了导管上的收缩球囊连同头部圆锥体一起从心脏瓣膜内移除;和
图5E示出了完全植入的整体式人工心脏瓣膜;
图6是用于输送该整体式人工心脏瓣膜的示例性系统的分解图;
图7是图6中的输送系统的装配图,示出了头部圆锥体延伸到瓣膜联接支架的远端之外;
图8是与图7相似的图,但是球囊导管向远端移动,从而使头部圆锥体脱离与联接支架的接合;
图9A和图9B是装配在瓣膜支托物上的示例性整体式人工心脏瓣膜的透视图;
图9C是图9A和图9B的组件的侧面正视图;
图9D和图9E是图9A和图9B的组件的远端平面图和近端平面图;
图10A和图10B分别示出了被示作处于扁平和管状扩展构造二者的示例性联接支架;
图11A-图11B示出了处于扁平构造和管状扩展构造二者的具有不连续上端的可替代联接支架;
图12A-图12D是另一可替代联接支架的平面图;
图13A-图13K是主动脉瓣环的立体分解图,其示出了在升主动脉下方的一部分相邻左心室,并示出了此处所公开的可替代整体式人工心脏瓣膜的展开中的许多步骤,即:
图13A示出了从存储和运输罐中移除之后且在内螺纹瓣叶分离护套附接到心脏瓣膜支托物期间的心脏瓣膜;
图13B示出了在准备主动脉瓣环以用于接收心脏瓣膜的过程中的预备步骤,包括安装导向缝合线;
图13C示出了被安装在输送手柄的远端部分上的心脏瓣膜,其沿着导向缝合线前进到主动脉瓣环内的位置;
图13D示出了在置换缝合勒除器期间在主动脉瓣环处的期望植入位置的心脏瓣膜;
图13E示出了手术镊,其向外弯曲缝合勒除器的上端以改善到心脏瓣膜和植入位置的通路;
图13F示出了通过输送手柄、支托物和心脏瓣膜插入之前朝着植入部位下降的球囊导管;
图13G示出了在球囊膨胀之前配合的输送手柄近端部分和远端部分以及心脏瓣膜的联接支架下方的球囊导管的远端;
图13H示出了球囊导管的球囊,其膨胀从而扩张联接支架;
图13I示出了收缩的球囊;
图13J示出了在移除勒除器之后使导向缝合线下降的三个紧固件夹子;
图13K示出了在移除导向缝合线期间完全植入的整体式人工心脏瓣膜,其中紧固件夹子固定在缝合环的近端面上;
图14和图15是装配在瓣膜支托物上的可替代整体式人工心脏瓣膜的上部透视图和下部透视图;
图16是图14的瓣膜支托物的下部透视图;
图17A-图17F是图14和图15的可替代整体式人工心脏瓣膜和支托物组件的数个平面图和正视图;
图18A-图18C是图14-图17的心脏瓣膜的联接支架的正视图、俯视图和仰视图,其第二末端处于收缩状态并形成圆锥形;
图19A-图19D是图14-图17的心脏瓣膜的联接支架的正视图、俯视图和仰视图和透视图,其第二末端处于扩张状态并同样形成圆锥形;
图20A-图20C是用于输送图14-图17的心脏瓣膜的系统的透视图、正视图和纵向剖视图,示出了处于膨胀构造的在球囊导管上的球囊并且省略了心脏瓣膜的联接支架;
图21是图20A-图20C的输送系统的正视图,其具有心脏瓣膜的联接支架;
图22是图21的输送系统的一些元件的分解图,但没有球囊导管、心脏瓣膜和支托物;
图23是图20A-图20C的输送系统、心脏瓣膜和支托物的分解透视图;以及
图24A-图24D是图20A-图20C的球囊导管和输送系统的近端手柄部分的透视图、正视图和纵向剖视图。
具体实施方式
本发明尝试克服与传统的心内直视手术相关的缺点,同时也采用减少了治疗过程的持续时间的一些较新技术。本发明的人工心脏瓣膜首先试图利用传统手术技术(包括前述的心内直视手术)被输送和植入。在这样的手术中存在许多方法,所有均会导致形成到特定心脏瓣膜瓣环的直接进入路径。为了简明,直接进入路径是允许心脏瓣膜瓣环的直接(即肉眼)可视化的一条路径。此外,将认识到,此处所描述的整体式人工心脏瓣膜的实施例也可以被构造为利用经皮方法和那些需要利用间接可视化进行远程瓣膜植入的微创手术方法来进行输送。
本发明的一个主要方面是一种整体式人工心脏瓣膜,其包括与瓣膜构件同时地植入组织锚点从而实现特定优势。本发明的示例性的整体式人工心脏瓣膜包含具有不可扩张部分和可扩张部分的混合瓣膜构件。与利用大量缝合线的传统缝合过程相比较,通过利用联接到不可扩张瓣膜构件的可扩张支架会大大减少锚点操作的持续时间。该可扩张支架可以简单地向外径向可扩张到接触植入部位,或可以具有额外的锚定装置,例如倒钩。可以利用传统的心内直视方法和心肺分流来实现该操作。在一种有利特征中,由于植入可扩张支架的相对速度的原因,会大大地降低了分流的时间。
为了定义的目的,术语“支架”或“联接支架”是指心脏瓣膜中能够附接到心脏瓣膜瓣环的组织的结构元件。此处所描述的联接支架是常见的管状支架,或是具有不同形状或不同尺寸的支架。支架一般是由生物相容性金属框架形成,例如不锈钢或镍钛记忆合金。更优选地,在本发明的背景中,支架均是由可塑性扩张金属的激光切割管材制造。可以与本发明的瓣膜一起使用的其他联接支架包括刚性环、螺旋缠绕的管以及紧密配合到瓣膜瓣环内且限定其中用于血液通过的孔口的其他这样的管子。然而,完全可以想象到,联接支架可以是并不限定连续周边的单独的夹子或钩子。尽管这些设备牺牲某些接触均匀性、速度和易展开性,但是这些设备可以被构造为结合特定瓣膜构件来工作。
本领域中自扩张支架和球囊扩张支架之间存在区别。自扩张支架可以被皱缩或以其他方式被压缩到小管子中,并具有足够的弹性以便当移除诸如外护套的限制件时自动向外弹出。正相反,球囊扩张支架是由基本弱弹性的材料制造,且实际上当从收缩直径转变为扩张直径时必须从内部向外塑性扩张。应当理解,术语球囊扩张支架涵盖可塑性扩张支架,无论是否实际使用球囊来扩张(例如,具有机械指状物的设备可以扩张支架)。在应用诸如膨胀球囊的变形力或扩张机械指状物之后支架的材料塑性变形。因此,术语“可球囊扩张的支架”应当被认为是指与特定膨胀装置形成对照的支架材料或类型。
术语“瓣膜构件”是指具有阻液表面以便在允许血液沿一个方向流动的同时防止血液沿另一个方向流动的心脏瓣膜元件。如上所述,瓣膜构件的各种构造均是可能的,包括具有柔性瓣叶的瓣膜构件和具有刚性瓣叶的瓣膜构件,或甚至是球笼设置。瓣叶可以是生物假体的、合成的、金属的或其它合适的权宜办法。
本发明的主要焦点是具有单级植入的整体式人工心脏瓣膜,其中外科医生将混合联接支架和瓣膜构件固定到瓣膜瓣环以作为一个单元或零件。混合联接支架和瓣膜构件的某些特征在于2008年12月19日提交的共同未决美国临时专利申请号61/139,398中被描述,其内容以参考方式包括进本发明。应当注意,前述应用中公开的“两级”人工瓣膜输送是指两个主要步骤:a)将结构锚定到瓣环,和之后b)连接瓣膜构件,不需要将瓣膜限制为正好两个零件。同样地,此处所描述的整体式瓣膜在单级植入过程中极其有利,但是不需要将整个系统限制为正好一个零件。例如,此处所公开的心脏瓣膜30也可以使用扩张底部支架,其然后由随后植入的心脏瓣膜来加固。因为该心脏瓣膜30具有不可扩张且不可收缩的瓣环支撑结构以及可塑性扩张联接支架36,所以其有效地阻挡自扩张底部支架的弹回。也就是说,关于所附的各权利要求可以排除多于一个零件的情况。
作为进一步定义的出发点,此处术语“可扩张”用于指能够从第一输送直径扩张为第二植入直径的心脏瓣膜元件。因此,可扩张结构并不意味着该结构由于温度上升或诸如作用于瓣叶或连合的流体动力学的其它偶然原因而会经受微膨胀。相反地,“不可扩张”不应当解释为完全刚性的或尺寸稳定的,因为例如可以观察到传统“不可扩张”心脏瓣膜的一些微膨胀。
在下面的描述中,术语“人体通道”用于定义体内的血管或脉管。当然,人工心脏瓣膜的具体应用确定了讨论中的人体通道。例如,主动脉瓣置换将被植入到主动脉瓣环中或邻近主动脉瓣环。同样地,二尖瓣置换将被植入到二尖瓣环。本发明的某些特征对一个植入部位或另一植入部位而言是特别有利的,尤其是主动脉瓣环。然而,除非组合是结构上不可行的,或是权利要求语言排除的,否则此处所描述的任何心脏瓣膜实施例均可以被植入任意人体通道。
此处所描述的“快速连接”主动脉瓣生物假体是用于治疗主动脉瓣狭窄的手术植入的医疗设备。示例性快速连接设备包括可植入生物假体以及用于其展开的输送系统。使用的设备、输送系统和使用方法优点在于被证实的血液动力学性能和现存商售的不可扩张人工心脏瓣膜(例如来自加利福尼亚州欧文的Edwards Lifesciences公司的Carpentier-Edwards PERIMOUNT Magna主动脉心脏瓣膜)的耐久性,且同时改善了其易用性并减少了总过程时间。这主要是通过省去了将生物假体缝合到天然瓣环上来实现的,该缝合过程在目前在每次标准手术实践中均要进行且围绕瓣膜周边一般需要12-24个手动打结的缝合线。而且,该技术可以省去切除钙化瓣膜的瓣叶以及清除或平整瓣膜瓣环。
图5A-图5E是通过隔离的主动脉瓣环AA的剖视图,示出了一部分相邻左心室LV和具有窦腔S的升主动脉。也示出了两个冠状窦CS。这一连串的图示出了本发明的包含整体式系统的示例性人工心脏瓣膜系统的展开中的数个步骤的快照。整体式人工瓣膜的联接支架抵靠天然瓣叶展开,或者如果切除了瓣叶则该联接支架抵靠被清除的主动脉瓣环AA展开。
图5A示出了被安装在球囊导管32上的整体式心脏瓣膜30,该球囊导管32在远端附近具有处于紧缩状态的球囊40(图5B),并且前进就位以便其近似轴向居中于主动脉瓣环AA。该整体式心脏瓣膜30包含人工瓣膜34以及附接到其远端并从该远端突出的联接支架36。在其径向约束或未展开状态时,联接支架36呈现朝着远端方向的圆锥形向内的锥度。球囊导管32延伸穿过心脏瓣膜30并终止于远端头部圆锥体38中,该远端头部圆锥体38具有圆锥形的或钟形的形状并覆盖联接支架36的锥形远端。如以下将示出的,导管32延伸穿过一个引入的插管和瓣膜支托物。
当用于主动脉瓣置换时,人工瓣膜34优选地具有三个柔性瓣叶,其提供了阻液表面从而代替天然瓣膜瓣叶的功能。在各种优选的实施例中,瓣膜瓣叶可以取自另一个人的心脏(尸体)、牛(牛科动物)、猪(猪瓣膜)或马(马科动物)。在其他的优选变型中,瓣膜构件可以包含机械元件而不是生物组织。三个瓣叶是由不可扩张、不可收缩的瓣环支撑结构和多个沿流出方向突出的连合柱支撑的。具有柔性瓣叶的典型人工心脏瓣膜包括为了易于瓣叶附接而由织物覆盖的一个或多个元件的合成(金属的和/或聚合物的)支撑结构。
例如,在优选的实施例中,人工瓣膜34包含商售的不可扩张的人工心脏瓣膜,例如可从Edwards Lifesciences公司获得的Carpentier-Edwards PERIMOUNT Magna主动脉心脏瓣膜。从这个意义上讲,“商售的”人工心脏瓣膜是现成的(例如,适合于独立销售和使用)人工心脏瓣膜,其限定了不可扩张、不可收缩的支撑结构并具有能够在心内直视手术过程中例如穿过缝合环的缝合线被植入的缝合环。所使用的进入心脏的特定方法是不同的,与心脏仍然起作用的心脏跳动手术形成对比,其在手术过程中心脏停止且被打开。重申一下,术语“不可扩张”和“不可收缩”不应当被解释为完全刚性且尺寸稳定,只不过瓣膜不像所提出的一些微创或经皮输送的瓣膜一样可扩张/可收缩。
人工瓣膜34具有联接支架36形式的可扩张联接机构,其用于将瓣膜固定到瓣环。尽管示出了联接支架36,但是联接机构可以采用许多不同的形式,不过消除了连接缝合线的需要,并提供了快速连接装置,因为其不需要将其缝合到瓣环这一耗时过程。
植入过程包括输送心脏瓣膜30和在主动脉瓣环处扩张联接支架36。因为瓣膜34是不可扩张的,所以一般利用传统的心内直视技术来实现整个过程。然而,因为通过简单的扩张来植入联接支架36,减少了缝合,所以整个操作花费较少的时间。对于熟悉心内直视过程和商售心脏瓣膜的外科医生而言该混合方法也将更加舒服。
而且,手术过程中相对较小的改变连同使用的已被验证的心脏瓣膜应当产生比严格可扩张远程手术过程更容易的管制路径。即使必须通过临床测试来满足食品与药物管理机构(FDA)的上市前的批准(PMA)过程(与510k提交物形成对照)才能确认该系统,至少通过已经证实的商售心脏瓣膜,例如Magna主动脉心脏瓣膜,将大大地简单化外科医生接受快速连接心脏瓣膜30。
在图5B中,心脏瓣膜30已经前进到主动脉瓣环AA处的期望植入位置。人工瓣膜34可以包括理想地邻接主动脉瓣环AA的缝合线可渗透环42。更优选地,缝合环42位于瓣环之上,或在主动脉瓣环AA的最窄点上方,以便于允许选择比在放置瓣环内的瓣膜更大的孔口。而且,在利用联接支架36使瓣环膨胀以及瓣环之上置换的情况下,外科医生可以选择尺寸比先前可能的瓣膜大一到两个增加量的瓣膜。如上所述,人工瓣膜34理想地是商售的具有缝合环42的心脏瓣膜。球囊导管32已经相对于心脏瓣膜30前进,从而使得头部圆锥体38移位而脱离与联接支架36接合。可以看到球囊导管32上的扩张球囊40恰超过联接支架36的远端。
图5C示出了导管32上的球囊40膨胀从而抵靠瓣环扩张并展开联接支架36。利用受控、加压、消毒的生理盐水使球囊40理想地膨胀。该联接支架36在其圆锥形的收缩状态和其大体管状或稍圆锥形扩张状态之间转变。在联接支架36和瓣环之间的简单干涉可以足以锚定心脏瓣膜30,或者可以使用相互作用的特征,例如突起、钩子、倒钩、织物等。
在优选的实施例中,联接支架36包含可塑性扩张的覆盖织物的不锈钢管状支架。利用可塑性扩张的支架的一个优势在于,能够扩张天然瓣环从而接收比传统手术可以接收的瓣膜尺寸更大的瓣膜。理想地,左心室流出道(LVOT)明显扩张至少10%,或例如明显扩张1.0mm-5mm,且外科医生能够选择相对于未扩张瓣环具有更大孔口直径的心脏瓣膜30。甚至瓣环尺寸增加1mm都是显著的,因为考虑到梯度与增加到第四倍率的半径成比例。
支架主体优选地构造为具有足够的径向强度,以用于把天然瓣叶推到一边并保持天然瓣叶打开处于扩张状态。天然瓣叶提供稳定底部以用于支撑支架,从而有助于将支架牢固地锚定在人体内。为了进一步将支架固定到周围组织,下部可以被构造为具有锚定构件,例如,钩子或倒钩(未示出)。应当理解,在无预先展开的底部支架的情况下,联接支架36理想地足够强固以便抵靠天然瓣环(瓣叶切除或未切除)直接锚定心脏瓣膜30。
同样,球囊40可以具有比其扩张近端更大的扩张远端,以便于将比施加于人工瓣膜34的力更大的力施加于联接支架36的自由端。用这种方法,人工瓣膜34和其中的柔性瓣叶并不承受来自球囊40的大扩张力。实际上,尽管示出了球囊展开,但是联接支架36也可以是自扩张类型的支架。在后一种构造中,头部圆锥体38适于在联接支架36到达主动脉瓣环内的心脏瓣膜30中的位置之前使联接支架36保持在其收缩状态。
如上所述,此处所描述的联接支架36可以是各种设计,包括具有所示的菱形/锯齿形状的开口或其他构造。进一步,该联接支架36可以包括倒钩或其他组织锚定物,从而进一步将支架固定到组织。倒钩可以是通过球囊扩张而可展开的(例如,被构造为径向向外延伸或被推动)。可替代地,可以利用形状记忆材料,以使得在植入时倒钩弯曲或卷曲。该联接支架36的材料取决于输送模式(例如,球状扩张或自扩张),且支架能够是裸撑杆材料或被覆盖成促进向内生长和/或减少瓣周泄漏。优选地,联接支架36例如通过涤纶管子等等而被覆盖成促进向内生长和/或减少瓣周泄漏。
图5D示出了在球囊导管32上的紧缩球囊40连同头部圆锥体38一起正在从心脏瓣膜30内移除。最后,图5E示出了本发明的完全展开的人工心脏瓣膜系统,其包括联接到主动脉瓣环AA的心脏瓣膜30。
图6是用于输送本发明的人工心脏瓣膜的示例性系统50的分解图,图7和图8是用于输送本发明的人工心脏瓣膜的示例性系统50的装配图。该输送系统50包括球囊导管52,球囊导管52在其远端上具有球囊40并在其近端上具有闭孔机54。闭孔机54导致了接收鲁尔连接器或其他这种诸如Y-配件58的紧固件的近端接头56。
前述的头部圆锥体38可以附接到导管52的最远端,但是更优选地附接到穿过球囊导管52的中心内腔被插入的金属线(未示出)。头部圆锥体38优选地固定到0.035”(英寸)导向金属线的末端,并具有适配到渐细联接支架36的渐细几何结构上的渐细几何结构,从而进行保护并防止当头部圆锥体38前进到天然钙化的主动脉瓣中时由支架卡住而引起的意外的钙移位。在将设备定位到主动脉根中以用于展开之前,该头部圆锥体38装配到心脏瓣膜30的远端上。通过将导向金属线从远端装入球囊导管52的内腔中并向近端前进直到位于且符合渐细联接支架36,来装配该头部圆锥体38。一旦假体处于期望位置且在球囊扩张之前,则外科医生使头部圆锥体38朝着心室方向前进,以允许球囊扩张。当头部圆锥体朝着心室方向前进且脱离与支架框架的接合时,头部圆锥体38萎陷到允许通过展开的主动脉瓣取回的尺寸。
导管52和头部圆锥体38穿过具有近端部分62和远端部分64的中空手柄60。远端手柄部分64的远端牢牢地附接到瓣膜支托物68的毂66,依次地,瓣膜支托物68附接到人工心脏瓣膜30。下面将参考图9A-图9E给出瓣膜支托物68的细节。
手柄60的两个部分62、64理想地由刚性材料形成,例如模塑塑料,且两个部分彼此联接从而形成相对刚性且细长的管子以用于操控附接到其远端的人工心脏瓣膜30。特别地,远端部分64可以容易地联接到支托物毂66,因此提供在术前清洗步骤期间用于管理心脏瓣膜30的便利工具。为此,远端部分64的特征在于,联接到支托物毂66的远端管状段70和在其近端具有开口的扩大近端段72,其中该开口用于接收近端手柄部分62的管状伸出74。
图6示出了O-环76,其可以被设置在管状伸出74的外部上以用于摩擦干涉配合从而防止两个部分脱离接合。尽管未示出,但是远端管状段70也可以具有用于牢牢地联接到支托物毂66的O-环,或可以通过螺纹等被附接。在一种优选实施例中,导管52上的球囊40被封装在近端手柄部分62内以用于保护和便于操作。联接近端手柄部分62和远端手柄部分64因此“装载”系统50,以便球囊导管52可以前进通过通向心脏瓣膜30的连续内腔。
在优选实施例中,人工心脏瓣膜30包括生物假体组织瓣叶,且被封装并存储地附接到支托物68,但是与引入系统50的其他元件分离。一般地,将生物假体组织封装并存储在具有防腐液的罐中以用于长期保存,同时在干燥状态下封装并存储其他元件。
当如图7和图8中装配时,细长内腔(未被标号)从Y-配件58的近端延伸至球囊40的内部。该Y-配件58理想地包括在内部有螺纹的连接器80以用于附接到吹入系统,或包括具有鲁尔配件84的侧端口82,或者类似的权宜手段可以用于球囊40的吹入。
图7和图8示出了导管52和关于手柄60及其相关结构的相关联结构的两个纵向位置。在图7中所示的缩进位置,球囊40主要存在于远端手柄部分64内。图7示出了引入系统50的输送构造,其中外科医生使得人工心脏瓣膜30从人体外部前进到邻近目标瓣环的位置。头部圆锥体38围绕圆锥形未展开联接支架36的远端延伸并保护该远端。在图5A中也可见该构造,虽然为了简洁起见移除了支托物68。应当注意到,近端联接56和手柄60的近端之间存在间距S。
如上关于图5A-图5E所述,外科医生使得人工心脏瓣膜30前进到瓣膜瓣环处的期望植入位置,然后使得球囊40前进通过心脏瓣膜并使其膨胀。为此,操作员将输送系统50从图7的缩进构造转换为图8的展开构造,其中由箭头78表明地向远端移动球囊导管40从而使得头部圆锥体38脱离与联接支架36的接合。应当注意到,近端接头56现在接触手柄60的近端,省去了图7中所表明的间距S。
在进一步描述输送系统50的操作之前,有必要更详细地说明心脏瓣膜30和瓣膜支托物68。图9A-图9E示出了安装在本发明的输送支托物68上的示例性心脏瓣膜30的许多透视图和其他视图。如上所述,心脏瓣膜30包括人工瓣膜34,人工瓣膜34具有附接到其入流端的联接支架36。在优选实施例中,人工瓣膜34包括商售现货的不可扩张、不可收缩的商用人工瓣膜。可以翻新这许多的人工心脏瓣膜,使其附接联接支架36,并因此适于在本发明的背景中使用。例如,人工瓣膜34可以是机械瓣膜或具有柔性瓣叶(其可以是合成的或是生物假体的)的瓣膜。然而,在优选实施例中,人工瓣膜34包括生物假体组织瓣叶86(图9A)。而且,如上所述,人工瓣膜34理想地是加利福尼亚州Irvine的Edwards Lifesciences公司商售的Carpentier-EdwardsPERIMOUNT Magna主动脉心脏瓣膜(例如,型号3000TFX)。
在制造过程期间,以保护缝合环的完整性和防止减少瓣膜的有效孔口面积(EOA)的方式,联接支架36优选地附接到瓣膜缝合环42的心室(或入流)方面。理想地,以维持缝合环的外部轮廓的方式将联接支架36连续地缝合到缝合环42。缝合线可以穿过支架骨架中的孔或孔眼,或穿过织物覆层,该织物覆层又被缝合到骨架上。其他连接方法包括从支架向内延伸的尖头或钩子、打结、维可牢尼龙搭扣、卡咬连接件、粘合剂等。可替代地,联接支架36可以更加刚性地连接到人工瓣膜34内的刚性元件。因此,在植入期间,外科医生能够根据传统的手术方法抵靠瓣环来放置缝合环42。这为外科医生提供了熟悉的触觉反馈,从而确保已经实现了适当的病人-假体匹配。此外,抵靠瓣环的出流侧放置缝合环42有助于减少心脏瓣膜30朝着心室迁移的可能性。
联接支架36可以是预先褶皱的、渐细的、316L不锈钢的可球囊扩张的支架,其理想地由聚酯下摆88覆盖,从而一旦被植入到瓣环内(参考图5E)则有助于密封防止瓣周泄漏并促进组织向内生长。该联接支架36在图5A-图5B和图9A-图9E的渐细收缩形状和图5C-图5E所述的扩口式扩张形状之间转变。
该联接支架36理想地包含多个锯齿状的或其他方式成角度的、蜿蜒或网状的撑杆90,撑杆90连接到三个大体轴向延伸的柱子92。如下面将要示出的,柱子92理想地构成一连串均匀隔开的孔,保持聚酯下摆88就位的缝合线可以被锚定到所述孔。最好参考图5E,当支架36被扩张时其向外扩口并严密地符合抵靠瓣环的内表面,并且具有与人工瓣膜34一样或更长的轴向长度。可以提供诸如倒钩的锚定设备或来自联接支架36的其它伸出部分来增强在联接支架和瓣环之间的摩擦固位。
应当理解,可以根据需要修改无论是拥有直撑杆还是拥有弯曲撑杆90的联接支架的具体构造。存在许多支架设计,下面参考图10-图12D将进行描述,其中任何一种都可能是适合的。同样地,尽管优选的实施例包括可球囊扩张的联接支架36,但是在某些改进(主要是针对输送系统)中可以替代地使用自扩张支架。在优选的实施例中,联接支架36理想地是可塑性扩张的,从而提供更牢固的锚定物以便将瓣膜34固定到具有或不具有天然瓣叶的瓣环。可以如下所述利用球囊或机械扩张器来扩张支架。
仍然参考图9A-图9E,支托物68包含前述的近端毂66和其上的较细的远端伸出94以形成支托物的中心部分。三条腿96a、96b、96c周向围绕中心伸出94等距分隔开并从其径向向外突出,其包含内部撑杆98和外部连合台100。人工瓣膜34优选地包括多个(一般是三个)沿出流方向突出的连合102。尽管未示出,但连合台100优选地包括连合102的尖端能够适配在其中的凹陷。
在一种实施例中,支托物68是由刚性聚合物形成的,例如迭尔林或聚丙烯,其是透明的从而增加植入过程的可见性。最好参考图9E,支托物68在腿96a、96b、96c之间呈现开口,从而为外科医生提供瓣叶86的良好可见性,并且腿的透明性进一步促进可见性和允许将光从中透过以最少化阴影。尽管此处并未详细地描述,但是图9E也示出了腿96a、96b、96c中的一连串通孔,其允许连接缝合线以便穿过人工瓣膜34中的织物并跨过每个腿中的切割引导件。本领域中众所周知的是,当需要时,切断被连接到支托物68并穿过瓣膜的缝合线的中间段允许从瓣膜自由地拉出支托物。
图9C和图9D示出了图9A和图9B中所示的稍微改进的联接支架36,其中更好地限定了撑杆90和轴向延伸的柱子92。具体地,柱子92比撑杆90稍宽且更强固,因为撑杆90为支架36提供从所示的圆锥形状扩张为更大的管状构造的能力。而且,大体圆形的加强环104邻接瓣膜缝合环42。柱子92和环104二者均进一步包括一连串通孔106,该一连串通孔106可以用于通过使用缝合线等而将聚酯下摆88固定到支架36。
图10A-图10B示出了处于扁平构造和管状构造二者的示例性联接支架36,管状构造大体是扩张的形状。如上所述,网状撑杆90和加强环104连接三个大体轴向延伸的柱子92。多个均匀隔开的孔106提供锚定物以用于将聚酯下摆88(参考图9B)保持就位。在所示的实施例中,网状撑杆90也包括一连串轴向延伸的撑杆108。连接到瓣膜的缝合环且由加强环104限定的联接支架36的上端沿着具有交替的弧形谷110和峰112的波状路径。如图9C中所示,示例性的人工瓣膜34具有波状缝合环42,联接支架36的上端符合该波状缝合环42。在优选的实施例中,支架36的几何结构匹配波状缝合环42的几何结构。当然,如果人工瓣膜的缝合环是平面的,那么联接支架36的上端也是平面的。还应当注意,图10B的管状形式是扩张构造的图解,不过球囊40可以过度扩张支架36的自由(下)端以至于其结束处呈现稍微圆锥形。
图11A和图11B再次分别示出了扁平构造和管状构造的可替代联接支架120。与第一个实施例一样,联接支架120包括在一连串轴向延伸的撑杆124之间延伸的网状撑杆122。在该实施例中,所有轴向延伸的撑杆124基本均是相同薄横截面尺寸。支架120的上端或连接端也包括加强环126,不过其被中断成由间隙隔开的一连串短长度段。上端限定了多个交替的谷128和峰130,同时加强环126的长度段限定峰。轴向延伸的撑杆124与支架120的上端的圆齿形同相位,且与峰及谷的中间一致。
构成加强环126的长度段之间的间隙允许支架120与许多不同尺寸的人工瓣膜34相匹配。也就是说,大部分支架120是可扩张的且具有可变直径,并且在加强环126中提供间隙允许上端也具有可变直径,以便能够成形成匹配相应缝合环的尺寸。这降低了制造成本,因为不需要针对每个不同尺寸的瓣膜提供相应尺寸的支架。
图12A是与联接支架120非常相似的进一步可可替代支架132的平面图,其包括被连接在一连串轴向延伸的撑杆136之间的网状撑杆134,并且通过由一连串短长度段的撑杆形成的加强环138来限定上端。与图11A和图11B的实施例形成对照,波状上端的峰具有与撑杆相对的间隙。另一种表示方法是轴向延伸的撑杆136与支架132的上端的圆齿形不同相,且与峰及谷的中间不对应。
图12B又示出了示例性的联接支架140,其具有在轴向延伸的撑杆144之间的可扩张撑杆142以及上部加强环146。该轴向延伸的撑杆144与支架的上端的峰和谷同相位。加强环146是之前描述这种环之间的混合,因为其绕其周边连续但是同样具有可变的厚度或金属线直径。也就是说,环146包含一连串由长度可变的较细跨接部分150连接的长度固定的撑杆长度段148,或换句话说,较细跨接部分150是可延展的。跨接部分150中的每个均被形成为具有半径,以便它们可以被弄直(拉伸)或更弯曲(压缩)。也可以在支架142的上端内形成一连串孔152,从而当将支架固定到相应人工瓣膜的缝合环时,为缝合线或其他附接装置提供锚定点。
在图12C中,可替代联接支架154与图12B中的支架140是相同的,只是轴向延伸的撑杆156与波状上端的峰和谷并不同相。
图12D示出了联接支架160的进一步变型,其具有连接轴向延伸的撑杆164的一连串锯齿形的可扩张的网状撑杆162。与图10A和图10B中所示的形式一样,网状撑杆162也由一连串轴向延伸的撑杆166连接,不过撑杆166比主要的轴向撑杆164更细。加强环168同样比网状撑杆162粗,并且特征在于每个谷中的一个或更多个间隙170以便该环是不连续的且是可扩张的。可以利用在轴向延伸的撑杆164、166上的倒钩172、174来增强在联接支架160及其所处的瓣环组织之间的保持力。
作为球囊的替代方案,机械扩张器(未示出)可以用于扩张上面所示的联接支架36。例如,机械扩张器可以包括由注射器状仪器致动的多个可伸开指状物,可参考在上文中被并入的美国临时专利申请号61/139,398。指状物是轴向固定的,但能够相对于圆筒枢转或弯曲。活塞的远端的外部直径大于可伸开指状物的内表面所界定的直径,因此活塞相对于圆筒向远端移动会逐渐向外顶处于联接支架内的指状物。因此,术语“可塑性扩张”涵盖可以通过所施加的力而实质变形从而呈现不同形状的材料。虽然一些自扩张支架可以变形到超过其最大扩张尺寸的施加力所导致的程度,但是形状改变的主要原因是与塑性变形对照的弹性回弹。
上面所述的整体式心脏瓣膜30可以被安装在球囊导管上前进到其上的植入位置,或是可以在瓣膜已经输送至瓣环之后引入球囊导管。图13A-图13K示出了植入顺序,其中外科医生首先将可替代整体式心脏瓣膜200输送至主动脉瓣环,且然后引入球囊导管从而展开联接支架202。应当理解,可以利用前述的心脏瓣膜30以及此处所公开的瓣膜和联接支架的任何组合来执行相同的过程。
图13A示出了从存储和运输罐移除之后且内部有螺纹的瓣叶分离护套204附接到心脏瓣膜支托物206期间的整体式心脏瓣膜200。心脏瓣膜200与上面所述的心脏瓣膜30是相似的,因为其包含人工瓣膜208和附接到其入流端并从该入流端突出的联接支架202。人工瓣膜208理想地具有由不可扩张的、不可收缩的瓣环支撑结构212和沿出流方向突出的多个连合柱214支撑的三个柔性瓣叶210。缝合线可渗透的环216界定人工瓣膜的入流端208。如上所述,人工瓣膜208包含一个或更多个元件构成的合成(金属和/或聚合物)支撑结构,且其上覆盖有织物以易于附接瓣叶。在一个示例性的形式中,人工瓣膜208是商售的不可扩张的人工心脏瓣膜,例如Edwards Lifesciences公司的Carpentier-Edwards PERIMOUNT Magna主动脉心脏瓣膜。下面将参考图14-图19描述整体式心脏瓣膜200的进一步细节。
在图13A和接下来的过程图中,整体式心脏瓣膜200被定向成入流端在下且流出端在上。因此,术语入流和下有时可以互换使用,且术语出流和上也可以互换使用。而且,根据外科医生首先输送心脏瓣膜入流端的视角来定义术语近端和远端,因此近端与上或出流意思相同,且远端与下或入流意思相同。
瓣叶分离护套204安装到装配管子220。尽管未示出,但护套204优选地在轻微干涉的情况下卡配在管子220的末端,以便可以轻易地从其分离。也可以提供某些形式的最小闩锁。联接支架202具有连接到人工瓣膜208的入流端的第一端(未示出)和所示的处于收缩状态以用于输送至植入位置的第二下端222。在收缩状态,联接支架202呈现截头圆锥体形状,其中第二下端222限定一开口,该开口足够大以便接收瓣叶分离护套204且其间具有间隙。护套204包括内螺纹224,其配合在瓣膜支托物206的指向下的凸台226上的外螺纹。技术员使管子220的末端上的护套204穿过支架第二端222,从入流侧分离柔性瓣叶210,并将护套旋到凸台226上。一旦技术员牢牢地附接护套204,则可以将装配管子220容易地从瓣膜200中拉出并移除。图13C中可见作为最终子组件。
用这种方式附接瓣叶分离护套204提供了一些好处。首先且最重要的,护套204限定了心脏瓣叶210水平面的通孔,以用于球囊导管从出流侧穿过。一般地,三个瓣膜瓣叶210遍及由支撑结构212限定的孔口,并具有大体沿着分开120°的三个线段汇集或“接合”的三个自由边,这三个线段在中心线处相交。这个构造呈天然瓣膜状,并且在允许血液沿一个方向流动但不会沿另一个方向流动方面执行得很好。尽管在使用中极其耐用,瓣膜瓣叶210是相对脆弱的且易于因为在植入过程中接触固体物体而受损,尤其是当瓣叶是由生物假体组织(例如牛心包膜或猪的异种移植物)制造而成时。因此,如下可见,分离护套204打开瓣叶210,并提供在瓣叶和穿过瓣膜的球囊导管之间的保护性隔板。如果没有护套204,则球囊导管将不得不强挤向后以穿过接合的瓣叶自由边。分离护套204的进一步好处是容易装配到支托物206。可以靠直觉通过瓣膜200附接到支托物206,并且移除装配护套220是简单的。瓣膜220和支托物206组件在使用之前存储在一起,通常存储在戊二醛或其它防腐剂的存储溶液中。该分离护套204优选地没有预先附接到支托物206,从而避免由于与其长期接触而导致瓣叶210中的任何压痕。也就是说,瓣叶210以其松弛状态或接合状态被存储。
图13B示出了准备主动脉瓣环AA用于接收心脏瓣膜200的预备步骤,包括安装导向缝合线230。示意性地示出的主动脉瓣环AA被隔离的,应当理解,为了简洁起见,并未示出各种解剖学结构。瓣环AA包括纤维性组织环,其从周围心脏壁向内突出。瓣环AA限定了在升主动脉AO和左心室LV之间的孔口。尽管未示出,但是天然瓣叶在瓣环AA处向内突出从而在孔口处形成单向瓣膜。瓣叶可以在进行手术过程之前被移除,或被保留在位置上,如上所述。如果移除了瓣叶,则也可以移除某些钙化的瓣环,例如通过咬骨钳。升主动脉AO在瓣环AA处开始且具有三个向外的凸出部分或窦,其中两个居中在通向冠状动脉CA的冠状心门(开口)CO。以下将看到,重要的是定向人工瓣膜208,以便连合214并不对齐冠状心门CO且因此不阻塞冠状心门CO。
外科医生将导向缝合线230附接在主动脉瓣环AA周围的三个均匀隔开的位置处。在所示的实施例中,导向缝合线230附接到冠状心门CO下方的位置或对应冠状心门CO的位置(即,两个导向缝合线230对齐心门,且第三个缝合线居中在非冠状窦下方)。所示的导向缝合线230从出流或升主动脉一侧向入流或心室一侧两次穿过瓣环AA打圈。当然,取决于外科医生的喜好,可以使用其他的缝合方法或脱脂棉。
图13C示出了导向缝合线230,其已经被固定以便每个导向缝合线230从瓣环AA以成对的自由长度段延伸并离开手术部位。该整体式心脏瓣膜200安装在输送手柄的远端部分240,且外科医生使瓣膜沿着导向缝合线230前进到主动脉瓣环AA内。也就是说,外科医生使得这三对导向缝合线230穿线通过缝合线可渗透的环216周围的均匀隔开的位置。如果导向缝合线230,如图所示,在主动脉窦下方锚定到瓣环AA,那么导向缝合线230在瓣膜连合柱214之间的中途穿线通过环216。支撑结构212通常包括波状形状的交替连合和尖瓣,因此导向缝合线230在瓣膜尖瓣处穿过缝合线可渗透的环216。而且,该示例性的环216具有波状入流侧,以便尖瓣位置在轴向上比连合位置厚,这提供了更多的材料来固定导向缝合线230。
现在参考图13D,心脏瓣膜200被搁在主动脉瓣环AA处的期望植入位置。缝合线可渗透的环216理想地接触瓣环AA的主动脉一侧,因此被称为处于瓣环上方位置。与将环216放置在瓣环AA内或瓣环下方形成对比,该位置使得能够选择更大孔口的人工瓣膜200,其中根据定义环216围绕瓣膜孔口。
外科医生将多个缝合线勒除器250沿导向缝合线230的每个自由长度段向下输送以接触缝合线可渗透的环216的上侧或出流侧。在植入手术过程期间,勒除器250能够对环216且因而对瓣膜200施加向下压力,这有助于保证将环216良好地被搁置在瓣环AA上。可以理解,勒除器250也提供围绕每个柔性导向缝合线230的刚性外壳,这有助于避免与下降的球囊导管缠结。因为存在三个导向缝合线230和六个自由长度段,所以可以使用六个勒除器250,然而也可以使用更多或更少的勒除器。勒除器250一般是医用塑料的类似吸管的管状构件。
在图13E中,可以看见手术镊252夹住缝合线勒除器250的上端,并使一对向外弯曲,从而提供进入心脏瓣膜200和植入部位的通路。图13F示出了在球囊导管260前进之前所有成对缝合线勒除器250均向外弯曲。尽管下面将更详细地描述,但是输送系统包括前述的手柄远端部分240,以用于操控在支托物206上的心脏瓣膜200。远端部分240是管状的,并限定了用于接收球囊导管260的内腔242,其中在球囊导管260远端具有处于未膨胀状态的球囊262。
现在参考图13G,示出的输送手柄近端部分244与远端部分240配合,以及在球囊膨胀之前远端球囊262延伸超过心脏瓣膜200的联接支架202。
图13H和图13I示出了球囊导管260的球囊262的膨胀和收缩,其使得联接支架202抵靠瓣环AA和一部分左心室LV塑性扩张。下面将进一步说明,球囊262以圆锥形外表面扩张,以便支架202的第二下端222向外扩张的比第一端更宽。最终的扩张支架202形成截头圆锥体表面。
随后,如图13J中所示,在移除勒除器250之后,外科医生将三个紧固件夹子270沿着导向缝合线230向下输送。图13K示出了完全植入的单个人工心脏瓣膜200,其中紧固件夹子270被固定在缝合线可渗透的环216的近端面上,并示出了导向缝合线230的移除。许多方法都可以用于将成对导向缝合线230固定在环216的出流侧上,包括传统的打结方法,然而紧固件夹子270符合缩短植入手术过程这一总目的。包含导向缝合线230主要是确保瓣膜200的适当旋转取向,如上所述,但是也有助于将瓣膜200固定在瓣环AA处的合适位置。也就是说,在输送瓣膜200之后可以可选地移除导向缝合线230,以便锚定瓣膜的唯一装置是扩张的联接支架202。如果不是完全无缝合线,则后一种选择将导致真正的“没有结的”瓣膜附接。
所示具有紧固件夹子270的构造消除了对缝合线打结的需要,并将导向缝合线230放置在天然瓣膜和人工假体的尖瓣使得夹子与缝合线分离,因此提高了可通达性。即使代替夹子270使用打结,仍可以将打结数降低到在连合柱之间三个打结,而不是之前所述的多个打结(12-24个),其中所述多个打结中的某些处于连合柱后面。使用三个缝合线正确地定位瓣膜200,且将缝合线居中在连合柱之间最易于通达以便打结,因为尖瓣在瓣环内的最低点。将结(或夹子)放置在瓣环中的最低点也有助于使冠状动脉闭塞的风险降到最小。
关于图14-图19更详细地理解了整体式心脏瓣膜200和支托物206。关于图14和图15,示出包括人工瓣膜208和联接支架202的心脏瓣膜200,其被附接到支托物206,由图16单独地示出支托物。在图17A-图17E中也可以看到组件。
如上所述,人工瓣膜208具有由不可扩张、不可收缩的瓣环支撑结构212和多个沿出流方向突出的连合柱214支撑的三个柔性瓣叶210,同时缝合线可渗透的环216界定其入流端。在一种实施例中,心脏瓣膜200是商售的具有缝合环216的不可扩张的人工心脏瓣膜208,例如Carpentier-Edwards PERIMOUNT Magna Aortic Bioprosthesis Valve,其被附接到由织物(例如,涤纶)下摆218加衬并/或覆盖的预皱缩渐细不锈钢联接支架202,如图15所示。下面关于图18-图19的详细支架附图示出了外部织物覆层或护套。
如图16所示,支托物206包括中心管状主体,该主体具有在下端上的指向下的凸台226、在上端上的指向上的毂227、毂下方的窄管状部分228以及具有三个指向外的锚定指状物229的部分(参考图14)。如上所述,连续圆筒形内腔从顶部到底部延伸了支托物206的长度,以用于球囊导管260的远端通过。指状物229包括将描述的锚定结构,该锚定结构允许附接到人工瓣膜208上的每个直立的连合柱214。
图16示出了指向下的凸台226,其具有外螺纹以用于与瓣叶分离护套204配合。三个间隙231使得凸台226与每个锚定指状物229的向下延伸部分分离,并为管状护套204提供瓣环空隙。在每个锚定指状物229的内表面上提供的小棘齿232接触分离护套204的外部,并优选地接触其表面粗糙部分,并提供抵抗旋转的摩擦从而将护套固定在凸台上。从底部看,每个齿232沿顺时针方向向内悬出,以便允许护套204被容易地旋上,但是存在阻碍沿逆时针方向旋开护套的阻力。
每个锚定指状物229包括大体平坦的下面233,该下面233在外边缘上由向下延伸的U-型轨道234加框。多个通孔235通过每个指状物229轴向延伸到上表面,如图17D中所示。特别地,第一对通孔235a从上切割引导件236径向向内开口,第二对通孔235b从切割引导件径向向外开口。最好参考图15,每个连合柱214的尖端均在U-型轨道234内接触一个锚定指状物229的下面233。连合柱214优选地由织物覆盖,或是其他方式缝合线可渗透的,且缝合线(未示出)用于将柱214固定到锚定指状物229的底侧。缝合线穿过第一对通孔235a和第二对通孔235b,以便中部延伸跨过切割引导件236中的间隔开的槽口237(再次参考图17D)。通过将缝合线的自由端固定在支托物206,例如固定在指状物229的底侧上,解剖刀可以用于切断延伸跨过切割引导件236中的切割井238的中部,从而将连合柱214从支托物释放。切断所有三个缝合线会将人工瓣膜208从支托物206释放。
图17A-图17F示出了优选的缝合线可渗透的环216,其界定了人工瓣膜208的入流端。环216限定了相对平的上面239和波状的下面241。瓣环支撑结构212的尖瓣在与下面241限定峰的位置相反的位置处邻接上面239。相反地,瓣膜连合柱214与下面241限定谷的位置对齐。下面241的波状有利地匹配瓣环AA的主动脉侧的解剖轮廓,即,匹配瓣环上方搁置处。环216优选地包含缝合线可渗透的材料,例如滚压的合成织物或由合成织物覆盖的硅树脂内核。在后一种情况中,硅树脂可以被模制成限定下面241的轮廓,且织物覆层与之相符。
在制造过程中联接支架202(图18-图19中分别示出的)以如下方式优选地附接到缝合线可渗透的环216,即保持环的完整性并防止减少瓣膜的有效孔口面积(EOA)。理想地,联接支架202将以保持环轮廓的方式连续地缝合到环216。关于这点,缝合线可以穿过沿着支架202的上端或第一端245排列的孔或孔眼243。其他连接方法包括从支架向内延伸的尖头或钩子、打结、维可牢尼龙搭扣、卡咬连接件、粘合剂等。可替代地,联接支架202可以更加刚性地连接到人工瓣膜208内的刚性元件。
在图18A-图18C中可以更详细地看到处于收缩状态的可塑性扩张的联接支架202,并且在图19A-19D中可以更详细地看到处于扩张状态的可塑性扩张的联接支架202。联接支架202的一般功能是提供用于将人工瓣膜208附接到天然主动脉根的装置。该附接方法试图作为将主动脉瓣生物假体缝合到主动脉瓣环的现有标准手术方法的替代性方法,且实现该附接方法需要更少的时间。进一步,该附接方法通过省去大部分但不是所有的缝合线而改善了易用性。
利用球囊导管来扩张和展开由织物(例如,涤纶)下摆覆盖的支架,从而实现装置附接到天然瓣膜结构。在图17F和图18-图19中,织物下摆218围绕支架202的外侧,并以虚线形式示出,但是也可以提供在支架的内侧上。该护套218的主要功能是有助于防止瓣周泄漏并提供将在主动脉瓣叶(如果被保留在位置上的话)和/或主动脉瓣环上的任何钙化结安全地封装起来的装置。
最好参考图17F,瓣膜200的优选实施例包括覆盖整个入流联接支架202的织物护套218,且结合了在ID、两端和部分OD上的聚四氟乙烯编织织物。最接近缝合环216的部分OD也用PET编织织物覆盖从而密封漏隙。覆盖整个联接支架202消除了暴露的金属,并降低了血栓栓塞事件和磨损的风险。
支架202可以与Edwards SAPIEN Transcatheter Heart Valve中使用的可扩张的不锈钢支架相似。然而,材料并不限于不锈钢,也可以使用其他材料,例如钴铬合金等。
图18A-图18C示出了处于其预褶皱渐细构造的支架202,这有助于插入通过钙化的天然主动脉瓣(参考图13C)。支架下边缘222绘制了比上端或第一端245所绘制的圆形直径更小的圆形。上端245沿着大体对应缝合线可渗透的环216的底侧241的波状轮廓的、具有峰和谷的波状路径(参考图15)。支架202的中部与图12B中所示的支架140稍微相似,并具有在轴向延伸的撑杆247之间的三行齿状的可扩张的撑杆246以及较粗的金属线上端245。该轴向延伸的撑杆247与支架的上端245的峰和谷同相位。由上端245限定的加强环围绕其周边连续,并具有由前述眼孔243中断的基本恒定的厚度或金属线直径。
被覆盖的支架202的上端245的最小I.D.(内直径)将始终大于支架202所附接的人工瓣膜208的I.D.。例如,如果上端245固定到缝合线可渗透的环216(其围绕瓣膜的支撑结构212)的底侧,那么根据定义,其将大于支撑结构212的I.D.。
图19A-图19C示出了在将心脏瓣膜200锚定到钙化的天然主动脉瓣(参考图13K)的、处于扩张构造的支架202。在图19C中看到从图18C的收缩尺寸扩张的支架下端222’。应当注意,形状不是精确的圆形,使用术语“直径”限定收缩大小和扩张大小必然是近似的。下面将进行说明的是,手术过程理想地包括将支架202从其最初的图18A的圆锥形扩张为其最终的图19A的圆锥形的成形扩张球囊262。在扩张步骤中,球囊262主要向支架202的下部施加更大的向外的力,因此上端245基本保持不变。这可以防止支架202所附接的缝合线可渗透的环216变形。
应当理解,可塑性扩张的支架202为心脏瓣膜200理想地提供充足的锚定力,并且也允许瓣环本身稍扩张。也就是说,可以使用自扩张的材料,不过这种支架将很可能需要附加的联接装置,例如倒钩、钉等。
图20A-图20C示出了用于输送图14-图17的整体式心脏瓣膜200的系统300。该输送或展开系统300由两件式手柄构成,其中一件是可移除且中空的并用作与生物假体的手柄接口。
图20A-图20C中示出的系统300中,人工瓣膜208被附接到支托物206,但是在观察和理解球囊262的功能中为了简洁起见省略了联接支架202。该系统300包括前述的球囊导管260,该球囊导管260开始于具有Y-配件302的近端并且终止于远端304。该球囊导管260延伸系统300的整个长度,下面将参考图24A-图24D进一步描述。整个系统优选地具有从Y-配件302的近端到远端304的长度L,该长度L在大约100mm和500mm之间。
本申请描述了基本刚性的输送系统,其中手柄306优选地由刚性聚合物构成,例如聚丙烯。可替代系统构想出可以弯曲偏开且具有高达800mm长度的柔性输送系统。这种输送系统的直径将不会和先前的经皮设备一样小,因为主要的通达线路是通过直接通达路径,且小直径不是必需的。
该系统300也包括两件式手柄组件306,其组合前述的与近端部分244配合的远端部分240。参考图21和图22将进一步描述手柄元件。手柄306的长度l优选地在大约150mm和300mm之间。Y-配件302与近端手柄部分244串联连接,该近端手柄部分244又联接到被附接于支托物206的远端部分240。贯通内腔延伸这些连接元件的长度,以用于球囊导管260滑动穿过,以便球囊262可以延伸通过人工瓣膜208。元件之间的连接包含同心管状接头,其中远端管子适配在近端管子内,从而降低当其穿过时划损球囊262的可能性。
图21是包括联接支架202的图20A-图20C的输送系统300的正视图,图22示出了分解的元件,但是没有球囊导管260、瓣膜200和支托物206。远端手柄部分240和近端手柄部分244包括在其配合端上的悬臂齿形式的卡扣联接器310,该悬臂齿卡咬到相应的接收孔(其中一个是在瓣膜支托物206的毂277上)内所形成的互补凹槽中。当然,也可以使用配合零件上的螺纹和其他类似的权宜手段。远端手柄部分240包括近端握把312,当附接到心脏瓣膜200时该握把312有助于操控心脏瓣膜200。同样地,近端手柄部分240包括外部握把314,从而使得使用户能够相对于邻近元件容易地联接和脱离联接,也提供了与远端部分握把308的连续性。
图21示出了被膨胀从而扩张瓣膜联接支架202的球囊262,而图23和图24A-图24D示出了球囊262的优选形状。如上所述,联接支架202的最终形状或扩张形状是截头圆锥形的,且球囊262包括与联接支架202接触的、向上渐细的中间区段320。该中间区段320具有相同的或稍大的圆锥夹角θ,以考虑到材料回弹。如图24D所示,圆锥角θ优选地在大约0°-45°之间,以及更优选地是大约38°(0°表明是圆柱扩张)。短的近端引入向上渐细段322和远端向下渐细段324侧翼包围向上渐细的区段320。可替代地,球囊262可以包括曲面或非轴向对称的轮廓,以便使联接支架202变形为各种期望的形状,从而更好地匹配在特定的瓣环内。事实上,在于2008年1月24日公开的标题为System for DeployingBalloon-Expandable Heart Valves的美国专利公开2008-0021546中描述了各种可能的形状,其内容明确地包括在本发明中。
在使用中,基于类型和大小来选择人工心脏瓣膜200(或瓣膜30)。一般地,心脏瓣膜200包括人工假体瓣叶,例如牛心包膜瓣叶,并仍被存储在无污染罐中的防腐溶液中。如果支托物206使用缝合线被附接到瓣膜,那么作为优选,支托物在存储和装运期间也被存在罐中。
在外科医生使心脏停止跳动并且暴露并测量瓣环的尺寸之后,他/她选择比瓣环大的瓣膜尺寸。技术员打开装纳所选瓣膜的罐子,并将远端手柄部分240卡到支托物毂227中且同时心脏瓣膜200和支托物206的组合仍在罐中。最终的组件有助于在术前准备(即,清洗步骤等)期间处理生物假体。在远端手柄部分240上的握把312有助于这些准备步骤。
外科医生将导向缝合线230置于尖瓣位置的瓣环中,然后退出并通过在相应位置的瓣膜缝合环。外科医生利用手柄组件306的远端240使瓣膜沿着导向缝合线230下滑从而将瓣膜压到瓣环内的适当位置,如图13C中所示。导向缝合线230有助于瓣膜200的旋转和轴向定位,因此瓣膜不会阻塞冠状心门并停靠在瓣环的顶部,如图13D所示。在通过导向缝合线230和勒出器250将瓣膜200固定在合适的位置之后,如图13E中所示,外科医生使球囊导管260(参考图13F)通过远端部分240,并利用近端部分244将其锁定在合适的位置,如图13G中所示。然后外科医生使球囊262膨胀,如图13H中所示,从而扩张联接支架202,其扩张瓣环,并将瓣膜200固定在正确的位置。在球囊膨胀之后,如图13I中所示,外科医生使支托物206与瓣膜200分离,并利用手柄上的握把312、314(参考图22)将支托物、手柄组件306和球囊导管260从病人中取回。
在第一实施例的情况中,其中整体式心脏瓣膜30安装在球囊导管32上,包括预装配在其中心内腔中的球囊40的近端部分62卡咬在远端部分64上,从而形成中空手柄60。当两个手柄件卡咬在一起时,具有包装好的球囊的球囊导管被封装在由两个配合手柄件形成的手柄轴中。
输送系统300为球囊导管提供了两个位置:
i:在手术过程的预先联接支架展开阶段使用的收缩的球囊位置。
ii:用于联接支架展开的前进的球囊位置。一旦心脏瓣膜200已经被放置在期望的主动脉根位置且需要扩张球囊来扩张联接支架并将植入物固定在合适的位置,则使用该前进的球囊位置。
当确保瓣膜200被适当放置时,外科医生利用盐水或相似的权宜手段使球囊262膨胀到其最大尺寸,或具有预定体积的膨胀流体来使得球囊262膨胀。这使得联接支架201抵靠瓣环(或瓣叶)扩张到其植入尺寸。然后,球囊262塌缩并从心脏瓣膜200中被移除。一旦完成展开,则使用解剖刀切割瓣膜支托物缝合线,并且输送系统300通过瓣膜瓣叶缩回从而完成展开过程。
在另一个有利的特征中,在前面的附图中所示的两元件瓣膜系统提供了与在移除天然瓣叶之后被缝合到组织的置换瓣叶相比较充分减少手术过程时间的设备和方法。例如,可以快速展开联接支架36、202,以便心脏瓣膜200、30可以快速地附接到瓣环。这减少了心肺分流所需的时间,因而实质性降低了病人的风险。
除了加速移植过程以外,包含瓣膜及其强健的可塑性扩张的支架的本发明允许扩张瓣环从而容纳比其他方式所实现的更大的瓣膜。特别地,临床研究已经示出左心室流出道(LVOT)能够通过可球囊扩张的支架被显著地扩张,并仍保持正常功能。在该背景中,“显著地扩张”LVOT是指扩张至少5%,更优选地在大约5%-30%之间,一般地在10%-20%之间。从绝对意义上来说,取决于标称孔口尺寸,LVOT可以扩张1.0mm-5mm。瓣环的这种扩张可能会增加被手术植入的人工瓣膜的尺寸。本发明在人工瓣膜的入流端使用可球囊扩张的瓣膜支架,其允许LVOT在主动脉瓣环或刚好在主动脉瓣环下方扩张。在联接支架的外部和LVOT之间产生的干涉配合会固定瓣膜,而理想地无需占空间的脱脂棉或缝合线,因而允许放置最大可能的瓣膜尺寸。可用于传统手术的更大的瓣膜尺寸增加了容积血流和降低了通过瓣膜的压力梯度。
本领域的技术人员将理解,本发明的实施例提供了重要的新设备和新方法,其中通过快速且高效的方式将瓣膜牢固地锚定到体腔中。本发明的实施例提供了用于在通过具有仅仅三个缝合线而不是一般用于主动脉瓣置换的12-24个缝合线的手术过程中植入人工瓣膜的装置。因此,充分减少了手术过程的时间。而且,除了为瓣膜提供联接支架以外,该支架还可以用于将天然瓣膜保持在扩张状态。因此,外科医生不需要移除天然瓣叶,因而进一步减少了手术过程的时间。
也将理解,本发明提供了改进的系统,其中可以通过更加快速和高效的方式置换瓣膜构件。更具体地,不需要切割任何缝合线来移除瓣膜。更确切地,瓣膜构件可以从联接支架断开,并且新的瓣膜构件可以连接在其位置。当利用生物组织瓣膜或具有有限设计生物的其他瓣膜时,这是重要的优势。
快速连接心脏瓣膜、系统和方法的变型可以基于外科医生的喜好、经验性测试、经济性等被改变。一些可能的变型包括:
提供附接装置且还防止天然的钙化瓣叶干扰流动的支架框架。
安装在缝合环的主动脉一侧有助于改善附接的次要件。
本申请涵盖了许多方式使人工瓣膜208联接到联接支架202,如以上所述。然而,优选的形式包括通过缝合线将联接支架202附接到瓣膜208的入流端,下面将参考图25-图28进行描述。
图25A示出了瓣膜208在联接支架202上方稍微分离,同时第一临时缝合线350连接在瓣膜208和联接支架202之间。该第一缝合线350包括在缝合环和瓣膜208的合成支撑结构212(例如,未示出的Elgiloy带)之间的缝合线材料(例如,P/N 400830001)的三周包绕圈(triple wraploop),其在连合214的中心处从缝合环216的顶部向下穿。针352通过缝合环216朝着瓣膜208的入流端向下引线、穿过联接支架202(在图25B中未示意性地示出)上的连合孔354到达支架的内部,并且往上返回通过缝合环216通过三周包绕圈被系紧。然后技术员在支架202的滚压凸出部上生成回针缝(backstitch),并修剪终端。这三个临时缝合线350被安装在瓣膜208的三个连合处。这三个缝合线用于将支架202定位在瓣膜208下方,且同时安装永久的缝合线。
应当注意,在该形式中,支架202的上端245遵循具有大体符合缝合环216的底侧的波状轮廓的带有峰和谷的波状路径。因此,临时缝合线350确保支架202的上端245的峰匹配位于瓣膜的连合214下方的缝合环216的谷。
图26A-图26D示出了永久缝合线360的示例性安装期间的几个初始步骤。优选地,技术员切割近似30英寸长的缝合线材料(例如,聚四氟乙烯线,P/N 491176003)长度段,并双线穿过针362。开始于连合中心处且在缝合环和Elgiloy带之间,使得针362向下通过缝合环216朝着入流端。穿过联接支架202上的连合孔354(图25B)到达支架内部,并往上返回通过缝合环216,通过缝合线圈364并系紧。向下返回通过缝合环216,勾住连合撑杆孔354和下一个竖直撑杆孔356(图25B)之间的支架202,到达支架的内部并往上返回通过缝合环,从而勾住前一针脚并系紧。一旦达到下一连合孔,则移除临时缝线350。
在每个支架孔处继续缝线,并且在每个支架孔之间产生了36个针脚,如图27和图28中所示。在所示的实施例中,支架202沿着上端245具有18个孔,其中三个连合孔354在峰处以及峰间的五个中间孔356,如图25B中所示。当然,支架202可以具有更多或更少的孔,或无孔,不过孔为装配技术员提供了安全的锚定、净间距和正确的目标。技术员通过将缝合线360再次穿过开始的连合孔、勾住第一个针脚并产生单个锁结可以完成缝合。然后缝合线360移动至支架202上的滚压凸出部,并且生成另一个隔行的单个锁结。技术员埋藏缝合线360并切割线。
在缝合环216区域上的针脚之间没有间隙,如图29中所示。在缝合环216和支架202之间也没有间隙。
尽管在优选的实施例中已经描述了本发明,但是应当理解,已经使用的词是用于描述而非限制的词。因此,在不偏离本发明的真正范畴的情况下可以在相关权利要求内做出改变。
Claims (22)
1.一种用于在心脏瓣膜瓣环处植入的人工心脏瓣膜,所述人工心脏瓣膜包含:
不可扩张的、不可收缩的瓣环支撑结构,其限定流动孔口并具有入流端;
瓣膜瓣叶,其附接到所述支撑结构并被安装成交替地打开和关闭所述流动孔口;
缝合线可渗透的环,其界定所述支撑结构的所述入流端;和
可塑性扩张的联接支架,其具有围绕所述流动孔口延伸并连接到在所述支撑结构的所述入流端处的瓣膜的第一端,所述联接支架具有第二端,该第二端背离所述支撑结构沿入流方向突出并能够呈现用于输送至植入位置的收缩状态和比所述第一端更宽以用于向外接触瓣环的扩张状态。
2.根据权利要求1所述的系统,其中所述支撑结构包括沿出流方向突出的多个连合柱,并且所述瓣膜瓣叶是柔性的并附接到所述支撑结构和连合柱。
3.根据权利要求1所述的系统,其中所述缝合线可渗透的环是缝合环,并且其中所述联接支架附接到所述缝合环。
4.根据权利要求1所述的系统,在所述收缩状态时所述联接支架是圆锥形的、从所述第一端朝着所述第二端向内渐细。
5.根据权利要求4所述的系统,其中在所述扩张状态时所述联接支架是圆锥形的、从所述第一端朝着所述第二端向外成锥形。
6.根据权利要求5所述的系统,其中所述联接支架包含多个径向可扩张的撑杆,其中至少一些撑杆排列成行,并且其中最远端一行具有从所述收缩状态到所述扩张状态的最大扩张能力。
7.根据权利要求1所述的系统,其中所述人工瓣膜包含商售的瓣膜,且所述缝合线可渗透的环是缝合环且所述可塑性扩张的联接支架被连接到所述缝合环。
8.一种输送和植入人工心脏瓣膜系统的方法,所述方法包含:
提供包括人工瓣膜的心脏瓣膜,该人工瓣膜具有不可扩张的、不可收缩的孔口,所述心脏瓣膜进一步包括从其入流端延伸的可扩张的联接支架,所述联接支架具有用于输送至植入位置的收缩状态和被构造为向外连接到所述瓣环的扩张状态;
使得具有在其收缩状态的所述联接支架的所述心脏瓣膜前进到邻近所述瓣环的植入位置;和
使所述联接支架扩张到所述扩张状态从而接触并连接到所述瓣环。
9.根据权要求8所述的方法,进一步包括将所述心脏瓣膜安装在具有近端毂和从中贯通的内腔的支托物上,和将所述支托物安装在手柄的远端上,其中该手柄具有从中贯通的内腔,所述方法包括使球囊导管穿过所述手柄和所述支托物的内腔并位于所述心脏瓣膜内,和使所述球囊导管上的球囊膨胀从而扩张所述联接支架。
10.根据权要求9所述的方法,进一步包括将被安装在所述支托物上的所述心脏瓣膜独立于所述手柄和所述球囊导管被包装。
11.根据权要求9所述的方法,其中所述联接支架的所述收缩状态是圆锥形的,并且其中所述球囊导管上的所述球囊具有比其扩张的近端更大的扩张的远端,以便将比施加于所述人工瓣膜的扩张偏转更大的扩张偏转施加于所述联接支架。
12.根据权利要求8所述的方法,其中所述联接支架的收缩状态是圆锥形的,并且其中所述联接支架包含多个径向可扩张的撑杆,其中至少一些撑杆排列成行,并且其中离所述人工瓣膜最远的一行具有从所述收缩状态到所述扩张状态的最大扩张能力。
13.根据权利要求8所述的方法,其中所述联接支架包含多个径向可扩张的撑杆,并且离所述人工瓣膜最远的一行具有交替的峰和谷,并且所述方法包括使所述联接支架的远端比所述联接支架的剩余部分扩张得更多,以便离所述人工瓣膜最远的一行中的峰向外突出到所述瓣环中。
14.根据权利要求8所述的方法,包括通过塑性扩张所述联接支架使所述心脏瓣膜环的孔口尺寸增加1.0mm-5mm。
15.根据权利要求14所述的方法,其中所述瓣膜元件的所述人工瓣膜被选择成具有与所述心脏瓣膜瓣环的增加的孔口尺寸相匹配的孔口尺寸。
16.一种用于输送人工心脏瓣膜的系统,所述系统包含:
包括人工瓣膜的心脏瓣膜,该人工瓣膜具有不可扩张的、不可收缩的孔口,所述心脏瓣膜进一步包括从其入流端延伸的可扩张的联接支架,所述联接支架具有用于输送至植入位置的收缩状态以及扩张状态;
被连接到所述心脏瓣膜的近端的瓣膜支托物;
具有球囊的球囊导管;和
手柄,其被构造为附接到所述瓣膜支托物的近端并具有用于所述导管通过的内腔,所述球囊向远端延伸通过所述手柄、经过所述支托物并通过所述心脏瓣膜。
17.根据权利要求16所述的系统,其中所述人工瓣膜包含具有缝合环的商售瓣膜,并且其中所述联接支架附接到所述缝合环。
18.根据权利要求16所述的系统,其中所述联接支架的所述收缩状态是圆锥形的、朝着远端方向向下渐细。
19.根据权利要求16所述的系统,其中所述联接支架的所述收缩状态是圆锥形的并朝着远端方向渐细,并且其中所述球囊导管进一步包括在其远端上的大体圆锥形头部圆锥体,其延伸通过所述心脏瓣膜并接合处于其收缩状态的所述联接支架的远端。
20.根据权利要求16所述的系统,其中所述手柄包含可以串联联接在一起从而形成连续内腔的近端部分和远端部分,并且其中所述远端部分适于联接到所述支托物的毂,从而使得能够利用所述远端部分在与所述近端手柄部分连接之前手动操控所述心脏瓣膜。
21.根据权利要求20所述的系统,其中所述球囊导管和近端手柄部分随位于近端部分内腔内的所述球囊一同被包装。
22.根据权利要求16所述的系统,其中被安装在所述支托物上的所述心脏瓣膜独立于所述手柄和所述球囊导管被包装。
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US12/821,628 | 2010-06-23 | ||
PCT/US2010/039746 WO2010151617A2 (en) | 2009-06-26 | 2010-06-24 | Unitary quick-connect prosthetic heart valve and deployment system and methods |
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AU2010264428B2 (en) | 2015-05-21 |
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CA2763524C (en) | 2017-03-21 |
EP2445450B1 (en) | 2020-12-09 |
US20130090725A1 (en) | 2013-04-11 |
WO2010151617A3 (en) | 2011-05-19 |
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BRPI1013796B8 (pt) | 2021-06-22 |
US9005277B2 (en) | 2015-04-14 |
US9901448B2 (en) | 2018-02-27 |
JP5647680B2 (ja) | 2015-01-07 |
JP2012531268A (ja) | 2012-12-10 |
US10555810B2 (en) | 2020-02-11 |
US8696742B2 (en) | 2014-04-15 |
BRPI1013796B1 (pt) | 2020-07-07 |
AU2010264428A1 (en) | 2011-12-22 |
CN102458309B (zh) | 2016-05-11 |
JP2015042313A (ja) | 2015-03-05 |
EP3332742A1 (en) | 2018-06-13 |
US20180185146A1 (en) | 2018-07-05 |
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