CN102256568B - 快速连接的人工心脏瓣膜和方法 - Google Patents
快速连接的人工心脏瓣膜和方法 Download PDFInfo
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Abstract
提供手术操作期间可迅速和容易地植入的心脏瓣膜假体。该人工瓣膜具有部署在治疗部位的基础支架,和被配置以快速连接到基础支架的瓣膜元件。基础支架可选取自身可扩展或球囊可扩展的支架的形式,其向外扩展接近具有或没有小叶切除的天然的瓣膜。瓣膜元件具有不可扩展的人工瓣膜和用于与基础支架相连的自身可扩展或球囊可扩展的连接支架,由此相对于基础支架固定瓣膜元件的位置。人工瓣膜可以是商业上可获得的、具有缝合环和与所述缝合环相连的连接支架的瓣膜。系统特别适于在常规的心脏直视手术环境中快速部署心脏瓣膜。提供基于导管的系统和用于部署的方法。
Description
发明领域
本申请要求2008年12月19日提交的美国临时申请号61/139,398的35U.S.C.§119(e)下的优先权。
本发明总体上涉及用于在身体通道中植入的人工瓣膜。更具体地,本发明涉及被配置为以比当前的瓣膜更少的时间进行手术植入的人工心脏瓣膜。
发明背景
在脊椎动物中,心脏是中空的肌肉器官,具有如在图1中所看到的四个泵室:左心房和右心房以及左心室和右心室,每个拥有其自己的单向瓣膜。将天然的心脏瓣膜识别为主动脉瓣、僧帽瓣(或二尖瓣)、三尖瓣和肺动脉瓣,每个瓣膜被安装在环中,该环包括直接或间接地连接到心房和心室的肌纤维的致密纤维环。每个环限定流动孔口。
心房是血液接收室,其将血液泵进心室。心室是血液排出室。壁由纤维和肌肉部分组成,被称作房间隔,其将右心房和左心房分开(参见图2至4)。与更易碎的心脏肌肉组织相比,纤维性的房间隔是实质上更强的组织结构。房间隔上的解剖标志是卵圆形的、拇纹大小的凹陷,称作卵圆窝或椭圆囊隐窝(图4中显示)。
心脏左侧和右侧同步的泵动作构成心动周期。该周期以被称作心室舒张的心室舒张期开始。该周期以被称作心室收缩的心室收缩期结束。四种瓣膜(参见图2和3)保证心动周期期间血液不以错误的方向流动,即,保证血液不从心室返流进入对应的心房,或从心房返流进入对应的心室。二尖瓣在左心房与左心室之间,三尖瓣在右心房与右心室之间,肺动脉瓣在肺动脉的开口处,主动脉瓣在主动脉的开口处。
图2和3显示邻近主动脉瓣无冠状动脉半月瓣(non-coronary leaflet)的二尖瓣环的前(A)部分。二尖瓣环在左冠状动脉旋支的附近,而后(P)侧接近冠状窦和其支流。
二尖瓣和三尖瓣由每个被称为环的胶原的纤维环限定,其形成心脏的纤维骨架部分。该环提供对二尖瓣的两个尖或小叶(称为前尖和后尖)和三尖瓣的三个尖或叶的周围连接。如图1所看到的,叶的游离缘连接至超过一个乳头肌的腱索。在健康的心脏中,这些肌肉和他们的腱索支撑二尖瓣和三尖瓣,使小叶抵抗左心室和右心室收缩(泵)期间形成的高压。
当用来自左心房的血液充盈之后的左心室收缩时,心室壁向内运动并从乳头肌和索释放一些张力。推向二尖瓣瓣叶下面的血液使得它们朝向二尖瓣的环平面上升。当它们向着环前进时,前小叶和后小叶的前缘会合,形成封口并关闭瓣膜。在健康的心脏中,叶接合发生在接近二尖瓣环的平面。血液继续在左心室被加压直到它射入主动脉。乳头肌的收缩与心室的收缩同时进行并用于在心室产生的最大收缩压时保持健康的瓣膜叶紧紧地关闭。
各种外科技术可用于修复患病的或受损的瓣膜。瓣膜换置操作中,将受损的小叶切除并将环造形以接收置换瓣膜。由于主动脉狭窄和其它心脏瓣膜疾病,每年数千患者进行外科手术,其中有缺陷的天然的心脏瓣膜被人工瓣膜——生物的或机械的——替换。另一种较不强有力的治疗有缺陷的瓣膜的方法是通过修复或重建,这典型地在最低程度地钙化的瓣膜上使用。外科手术治疗的问题是显著的创伤,它将与手术修复相关的高的发病率和死亡率强加给这些慢性病患者。
当置换瓣膜时,人工瓣膜的手术植入典型地需要开胸手术,手术期间让心脏停止跳动并将患者放到心肺转流机(所谓的“人工心肺机”)。在一个通常的手术操作中,切除患病的天然瓣叶,在瓣膜环处将人工瓣膜缝合到周围的组织。由于与操作相关的创伤和体外血液循环的护理持续时间,一些患者没有幸免于手术操作或其后不久死亡。熟知的是患者的危险随着体外循环需要的时间量而增加。由于这些危险,大量的具有缺陷瓣膜的患者被认为不能动手术,因为他们的状况太虚弱了,不能经受住操作。据一些估计,约30至50%的患主动脉狭窄的年龄超过80岁的对象不能进行手术用于主动脉瓣置换。
由于与常规的心脏直视手术相关的缺点,经皮和微创的手术方法正得到强烈关注。在一种技术中,人工瓣膜被配置以通过导管插入术、以小得多的侵害性的操作进行植入。例如,Andersen等人的美国专利号5,411,552描述了通过导管以压缩的状态经皮引入并通过球囊膨胀(balloon inflation)而在期望的位置扩展的可收缩的瓣膜。尽管这些遥远的植入技术已显示治疗某些患者的很大希望,但是通过外科干预更换瓣膜仍然是优选的治疗操作。接受遥远的植入的一个障碍是来自医生的抵抗,这些医生可理解地对于从一种有效的——如果不完美的——方案转变成承诺重大结果但是相对外来的新方法的焦虑。与在转变为心脏瓣膜置换的新技术中外科医生履行的可理解的谨慎连起来,全世界监管机构也正慢慢地推动。无数成功的临床试验和随访研究正在进行中,但是在它们被完全接受之前将需要更多的关于这些新技术的经验。
因此,对改进的装置和使用的相关方法存在需要,其中人工瓣膜能在减少体外循环需要的时间的更有效的操作中被手术植入身体管道。期望这样的装置和方法能帮助被认为不能动手术具有缺陷瓣膜的患者,因为这些患者的状况太虚弱了以至于不能经得起过长的常规手术操作。本发明解决这些需要和其它需要。
发明概述
本申请的各种实施方式提供用于在人心脏中替换有缺陷的天然瓣膜的人工瓣膜和使用方法。某些实施方式特别适合用于快速并容易地置换心脏瓣膜、同时最小化使用体外循环(即旁路泵)的时间的手术操作中使用。
在一个实施方式中,在人心脏中治疗天然的主动脉瓣以替换主动脉瓣功能的方法,包括:1)通过在胸部的开口接近天然的瓣膜;2)将可扩展的基础支架推进到天然的主动脉瓣位置,在推进期间将基础支架放射状地压缩;3)在天然的主动脉瓣位置处放射状地扩展基础支架;4)在基础支架的腔内推进瓣膜元件;和5)在瓣膜元件上扩展连接支架以快速并有效的方式机械地连接到基础支架上。
在一个变型中,基础支架可包括金属框架。在一个实施方式中,至少部分的金属框架由不锈钢制成。在另一个实施方式中,至少部分的金属框架由形状记忆材料制成。瓣膜元件可选取各种形式。在一个优选的实施方式,瓣膜元件包括生物组织。在该方法的另一个变型中,在将人工瓣膜向天然的主动脉瓣推进期间在荧光检查下观察金属框架。
在递送人工瓣膜之前可去除天然的瓣膜小叶。可选地,可将天然小叶放在合适的位置以减少手术时间和在天然的瓣膜内为固定基础支架而提供稳定的基底。在该方法的一个优点中,天然小叶向内退缩以加强金属框架在身体管道中的固定。当将天然小叶放在合适的位置时,球囊或其它扩展元件可用于推动异常的瓣膜小叶并因此在植入基础支架之前扩大天然的瓣膜。天然的环可从它们最初的孔尺寸被扩大到1.5-5mm之间以容纳较大尺寸的人工瓣膜。
根据优选的方面,人工心脏瓣膜系统包括适于锚定心脏瓣膜环并在那里限定孔口的基础支架,和连接基础支架的瓣膜元件。该瓣膜元件包括人工瓣膜,其在那里限定不可扩展的、不可收缩的孔口和可扩展的连接支架,该支架从其流入端伸展。连接支架具有用于递送到植入位置的收缩状态和配置用于向外连接到基础支架的扩展状态。基础支架还可以是可扩展的,其中收缩状态用于递送到邻近心脏瓣膜环的植入位置而扩展状态大小适于连接和锚定心脏瓣膜环。期望地,基础支架和连接支架都是可塑性地可扩展的。
在一个实施方式中,人工瓣膜包括具有缝合环的商业上可获得的瓣膜,并且连接支架与缝合环相连。连接支架的收缩状态可以是圆锥形的,在远端方向逐渐变细。连接支架优选地包括多个放射状地可扩展的支杆,至少一些支杆成行排列,其中最远端的行具有从收缩状态扩展到扩展状态的最大能力。还进一步,距人工瓣膜最远的支杆行具有交替的尖点和凹陷处,其中基础支架包括孔,在该孔中连接支架的尖点可突出以连结两个支架。基础支架可包括轴向定位的支杆之间的多个放射状地可扩展的支杆,其中轴向定位支杆的至少一些具有较高的突出部分,该突出部分区分支架周围的位置。
本文还公开人工心脏瓣膜系统的递送和植入的方法,包括步骤:
将基础支架推进到邻近心脏瓣膜环的植入位置;
将基础支架锚定到心脏瓣膜环;
提供瓣膜元件,该瓣膜元件包括具有不可扩展的、不可收缩的孔口的人工瓣膜,该瓣膜元件进一步包括从其流入端伸展的可扩展的连接支架,该连接支架具有用于递送到植入位置的收缩状态和配置用于向外连接到基础支架的扩展状态;
将具有连接支架的瓣膜元件以其收缩状态推进到邻近基础支架的植入位置;和
将连接支架扩展到扩展状态,与基础支架接触并相连接。
基础支架可以是可塑性地可扩展的,该方法进一步包括将可扩展的基础支架以收缩状态推进到植入位置,和可塑性地将基础支架扩展到扩展状态,与心脏瓣膜环接触并锚定到心脏瓣膜环,在该过程中增加心脏瓣膜环的孔口尺寸至少10%或1.5-5mm。期望地,选择瓣膜元件的人工瓣膜以具有与心脏瓣膜环增加的孔口尺寸匹配的孔口尺寸。该方法还包括将基础支架安装在机械扩张器上,和使用机械扩张器将基础支架部署在心脏瓣膜环上。
方法的一个实施方式进一步包括将瓣膜元件安装在具有通过其的近端的插孔和腔的固定器上。固定器安装在具有通过其的腔的手柄的远端,和该方法包括使球囊导管穿过手柄和固定器的腔并且瓣膜元件内,并在球囊导管上使球囊膨胀以扩展连接支架。可将安装在固定器上的瓣膜元件与手柄和球囊导管分开包装。期望地,连接支架的收缩状态是圆锥形的,球囊导管上的球囊具有较其近端扩展端大的远端扩展端,以便施加到连接支架较人工瓣膜更大的膨胀偏转。
在其中连接支架是圆锥形的方法中,连接支架可包括多个放射状地可扩展的支杆,其中至少一些成行排列,其中距人工瓣膜最远端的行具有从收缩状态扩展到扩展状态的最大能力。
方法可利用具有多个放射状地可扩展的支杆的连接支架,其中距人工瓣膜最远的行具有交替的尖点和凹陷处。连接支架的远端因此较连接支架的其余部分扩展更多,以便距人工瓣膜最远的行中的尖点向外突出进入基础支架的口中。基础支架和连接支架都可具有轴向定位的支杆之间的多个放射状地可扩展的支杆,其中该方法包括定位连接支架以便其轴向定位的支杆与那些基础支架异相以增加其间的保留。
本文描述的另一个方面是用于递送瓣膜元件的系统,该瓣膜元件包括具有不可扩展的、不可收缩的孔口的人工瓣膜,和可扩展的连接支架,该连接支架从其流入端伸展,连接支架具有用于递送到植入位置的收缩状态以及扩展状态。递送系统包括与瓣膜元件的远端连接的瓣膜固定器、具有球囊的球囊导管和配置以与瓣膜固定器近端相连的手柄,该手柄具有用于导管通过的腔,其中球囊向远端伸展通过手柄、经过固定器并通过瓣膜元件。在系统中,人工瓣膜优选地是具有缝合环的商业上可得的瓣膜,连接支架与缝合环相连。
递送系统中连接支架的收缩状态可以是圆锥形的,在远端方向逐渐变细。此外,球囊导管进一步可包括其远端末端上的大体圆锥形的鼻锥,该鼻锥伸展通过瓣膜元件,并以其收缩状态接合连接支架的远端。期望地,手柄包括可串联连接在一起以形成连续的腔的近端部分和远端部分,其中使远端部分适合连接固定器的插孔以在与近端手柄部分连接之前使用远端部分实现瓣膜元件的手动操作。优选地,将球囊导管和近端手柄部分与球囊一起包装在近端部分腔内。
权利要求21的系统,其中将安装在固定器上的瓣膜元件与手柄和球囊导管分开包装。本发明的性质和优点的进一步理解在以下的说明书和权利要求书中说明,特别地当与附图连同考虑时,附图中类似的部分具有类似的参考数字。
附图说明
现在将说明本发明,参考所附的示意图,其它优点和特征将显示,其中:
图1是人心脏的解剖学前视图,其中部分被打开并部分地观察心脏的室的内部和邻近结构;
图2是部分的人心脏的解剖学上视图,显示右心房中的三尖瓣,左心房中的二尖瓣,和二者之间的主动脉瓣,其中心动周期的心室舒张(心室充盈)期间三尖瓣和二尖瓣打开,主动脉瓣和肺动脉瓣关闭;
图3是图2中显示的部分的人心脏的解剖学上视图,其中心动周期的心室收缩(心室排空)期间三尖瓣和二尖瓣关闭,主动脉瓣和肺动脉瓣打开;
图4左心房和右心房的解剖学前透视图,其中部分被打开并以部分显示心脏的室的内部和相关结构,诸如卵圆窝、冠状窦和左冠状静脉;
图5A-5H是通过分离的主动脉环的剖视图,显示相邻的左心室和主动脉的部分,并图解本发明的示例性的人工心脏瓣膜系统部署中的多个步骤;
图5A显示瘪的球囊导管,该导管在其上具有被推进到主动脉环的位置的基础支架;
图5B显示导管上、被膨胀以接近主动脉环扩展和部署基础支架的球囊;
图5C显示主动脉环内位置中部署的基础支架;
图5D显示安装在球囊导管上、推进到基础支架内的位置的瓣膜元件;
图5E显示主动脉环和基础支架内期望的植入位置中的瓣膜元件,其中球囊导管被更远地推进以用连接支架替换脱离接合的鼻锥;
图5F显示导管上、被膨胀以接近基础支架扩展和部署瓣膜元件连接支架的球囊;
图5G显示导管上、和鼻锥正一起被从瓣膜元件内除去的瘪的球囊;
图5H显示完全展开的本发明的人工心脏瓣膜;
图6是递送本发明的人工心脏瓣膜的示例性系统的分解图;
图7是图6的递送系统的组装图,显示延伸超过瓣膜元件连接支架远端的鼻锥;
图8是和图7相似的图,但是具有远端替代的球囊导管以使鼻锥从连接支架脱离;
图9是与图7显示的递送系统相似的递送系统的组装图,并显示膨胀以扩展瓣膜元件连接支架的球囊;
图10是图9的导入系统的几个元件的分解正视图,没有球囊导管、瓣膜元件和固定器;
图11A和11B是装配到本发明的瓣膜固定器上的示例性瓣膜元件的透视图;
图11C是图11A和11B组装的侧视图;
图11D和11E是11A和11B组装的俯视图和仰视图;
图12A-12B图解扁平结构(12A)和管状扩展结构(12B)中的示例性连接支架;
图13A-13B图解扁平和管状扩展结构中具有不连续顶端的可选的连接支架;
图14-17是还进一步可选的连接支架的平面图;
图18A-18B是具有上位置标记和其上重叠的模型连接支架的示例性基础支架的扁平和管状视图;
图19是其上具有重叠的连接支架的可选的基础支架的平面视图;
图20是基础支架内连接支架的剖视图,说明联锁的一种方法;和
图21-23是用于递送和扩展具有机械手指的基础支架的装置的透视图。
优选的实施方式的详述
本发明试图克服与常规的心脏直视手术相关的缺点,同时也采用减少治疗操作持续时间的较新技术中的一些技术。本发明的人工心脏瓣膜主要期望使用包括前述心脏直视手术在内的常规的外科技术递送和植入。在这样的外科手术中有许多途径,所有这些途径导致形成到特定心脏瓣膜环的直接进入途径。为了阐明,直接进入途径是允许直接(即裸眼)可视化心脏瓣膜环的一种途径。此外,将认识到本文描述的两阶段人工心脏瓣膜的实施方式还可被配置成使用经皮方法和需要使用间接可视化的远距离瓣膜植入的那些微创外科方法进行递送。
本发明的一个主要方面是两阶段人工心脏瓣膜,其中首先植入组织锚然后植入瓣膜部件的任务是不同的并且具有某些优点结果。本发明的示例性的两阶段人工心脏瓣膜具有使用球囊或其它扩展技术固定到组织适当位置的可扩展的基础支架。具有不可扩展和可扩展部分的混合瓣膜部件然后以不相连的或连续的操作连接到基础支架。通过利用可扩展的基础支架,与利用一组缝线的常规的缝合操作相比,最初锚定操作的持续时间大大减少。可扩展的基础支架可简单地放射状地向外扩展,接触植入位点,或可具有另外的锚定装置诸如倒钩。可使用常规的心脏直视方法和心肺转流术进行该操作。在一个有益的特征中,由于植入可扩展的基础支架的相对速度,旁路上的时间被大大减少。
为了明确的目的,术语“基础支架”指能与心脏瓣膜环的组织相连的心脏瓣膜的结构构件。本文所描述的基础支架大多是典型地管状支架或具有变化的形状或直径的支架。支架通常由生物相容的金属线框——诸如不锈钢或镍钛金属互化物(Nitinol)——形成。能与本发明的瓣膜一起使用的其它基础支架包括硬质环、水平围绕管圈(spirally-wound tubes)和其它这样的管,所述其它这样的管在瓣膜环内紧密配合和限定通过其、用于血液通过的孔口,或瓣膜部件被安装在其内。然而,完全能想得到的是基础支架可以是不限定连续边缘的分开的夹子或钩。尽管这样的装置牺牲了一些动态稳定性以及部署的速度和方便,但是这些装置可被配置以与特定的瓣膜部件连起来工作。
在本领域中存在自身扩展和球囊扩展支架之间的区别。自身扩展支架可被卷曲或以其它方式压缩成小管,并且当限制诸如外鞘被去除时拥有足够的弹性以通过自身向外弹开。相反,球囊扩展支架是由基本上较小弹性的材料制成,而当从压缩的直径转变成扩展的直径时实际上必须从内部向外被可塑性地扩展。应当理解的是术语球囊扩展支架包括可塑性地可扩展的支架,不论是否球囊被用于实际上扩展它。在施加变形力诸如正在膨胀的球囊或扩展机械手指之后,支架的材料可塑性地变形。下面将描述两种选择。因此,术语“球囊可扩展的支架”应考虑指与特定的扩展装置相反的支架的材料或类型。
术语“瓣膜部件”指心脏瓣膜的元件,其具有流体咬合表面以防止血液以一个方向流动,同时允许其以另一个方向流动。如上面所提到的,瓣膜数目的各种构建物是可获得的,包括具有弹性小叶的那些构建物和具有刚性小叶的那些构建物或球形和笼形结构。小叶可以是生物假体的、合成的或金属的。
本发明的主要焦点是两阶段人工心脏瓣膜,其具有第一阶段,其中基础支架固定到瓣膜环,和随后的第二阶段,其中瓣膜部件连接到基础支架。应当指出,这些阶段可以几乎同时进行,诸如如果两个元件被安装在同一个递送装置上,或可以以分开的临床步骤进行,其中使用第一递送装置部署基础支架,然后使用另一个递送装置部署瓣膜部件。还应指出,术语“两阶段”指将结构锚定到环然后连接瓣膜部件的两个主要步骤,其不必需将瓣膜限制成刚好两部分。
包括基础支架和瓣膜部件的两阶段人工心脏瓣膜的另一个潜在的好处是植入之后该瓣膜部件可被替换,而不用替换基础支架。即,可使用连接瓣膜部件和基础支架的容易地可拆卸的装置,该装置允许相对容易地植入新的瓣膜部件。本文描述连接瓣膜部件和基础支架的各种结构。
因此,应当理解,本发明的某些好处不依赖于基础支架是否是可扩展的。即,各种实施方式说明连接到混合瓣膜部件的可扩展的基础支架,该部件具有不可扩展的和可扩展的部分。然而,相同的连接结构可用于不可扩展的基础支架和混合瓣膜部件。因此,本发明应通过所附的权利要求书来解释。
作为进一步定义的点,本文使用术语“可扩展的”指能够从第一递送直径到第二植入直径扩展的心脏瓣膜的元件。可扩展的结构因此不是指根据温度上升或其它这样的偶然原因可经历轻微扩展的结构。相反,“不可扩展的”不应被解释为意指完全刚性的或在尺寸上稳定的,因为,例如,可观察到常规的“不可扩展的”心脏瓣膜的一些轻微扩展。
在后面的描述中,术语“身体管道”用于定义身体内的血液管道或血管。当然,人工心脏瓣膜的特定应用确定讨论之中的身体管道。主动脉瓣置换,例如,将被植入到主动脉环中或邻近主动脉环。同样,二尖瓣置换将被植入到二尖瓣环。本发明的某些特征对一种植入位点或其他的是特别有利的。然而,除非组合在结构上是不可能的,或被权利要求语言所排除,本文描述的任何心脏瓣膜实施方式可被植入到任何身体管道中。
图5A-5H是通过分离出的主动脉环AA的剖视图,显示部分的邻近的左心室LV和具有窦腔(sinus cavities)S的升主动脉。还显示两个冠状窦CS。该系列视图显示部署本发明的示例性人工心脏瓣膜系统的多个步骤的快照,其包括两元件系统。第一元件是靠近天然小叶或,如果小叶被切除,靠近清创主动脉环AA部署的基础支架。第二瓣膜元件在基础支架内安装并锚定到那里。尽管两部分瓣膜是本领域已知的,但是相信利用与不可扩展的瓣膜连起来的支架内的支架是第一次。
图5A显示具有接近远端处于瘪的状态的球囊22的导管20,其中管状基础支架24在球囊22上卷曲。支架24以放射状地收缩的、未展开的结构显示。导管20已被推进以定位基础支架24,以便其近似轴向地集中在主动脉环AA处。
图5B显示膨胀以接近主动脉环AA扩展和展开基础支架24导管20上的球囊22,图5C显示使球囊22放气和去除导管20之后处于适当位置的展开的基础支架。支架24在体腔内并接近体腔(例如瓣膜环)提供基底。尽管是为了说明的目的描述支架,但是可使用能在体腔内并接近体腔锚定然后连接瓣膜元件的任何部件。在优选的实施方式中,基础支架24包括可塑地可扩展的包织物的不锈钢管状支架。使用可塑地可扩展的支架的一个优点是扩展天然的环以接受比常规的手术更大的瓣膜尺寸的能力。期望地,左心室流出道(LVOT)被显著地扩展至少10%,或例如1.5-5mm,外科医生能选择具有相对于未扩展的环较大的孔口直径的瓣膜元件30。另一方面,本发明还可使用自扩展的基础支架24,其然后被随后植入的瓣膜元件30加强。因为瓣膜元件30具有不可压缩的部分,人工瓣膜34,和期望地是可塑地可扩展的连接支架36,所以它有效地抵抗自扩展的基础支架24的弹回。
连续的参考图5B,支架24具有大小适于部署在天然的瓣膜位置(例如沿着主动脉环)的直径。支架24的部分可向外扩展进邻近天然瓣膜的各自的腔。例如,在主动脉瓣置换术中,上部可扩展进刚好距主动脉环下游的窦腔的区域。当然,应小心定向(前面是定位)支架24以至于不阻断管状开口。支架主体优选地配置有足够的放射状的强度用于在膨胀情况下推开天然小叶和保持天然小叶打开。天然小叶提供稳定的基底用于支持支架,由此有助于安全地将支架锚定在身体中。为了进一步使支架固定到周围组织,下部可配置有锚定部件,诸如,例如,钩或倒钩(未显示)。
如下面将更详细地描述的,人工瓣膜系统包括可快速和容易地连接到支架24的瓣膜元件。这里应指出,本文描述的基础支架可以是各种设计,包括显示的具有菱形/人字形(chevron-shaped)开口或其它结构。材料取决于递送(即球囊或自扩展)的方式,支架可以是光秃的支杆材料或被涂布以促进向内生长和/或以减少瓣膜旁渗漏。例如,常常使用的合适的覆盖物是织物诸如达克龙(Dacron)的套。
本发明的人工心脏瓣膜系统的一个主要优点是部署速度。因此,基础支架24可采取许多不同结构,只要它不需要将它缝合到环的费时的过程。例如,基础支架24的另一个可能的结构是象所显示的管状支架一样的不是完全可扩展的基础支架。即,基础支架24可具有不可扩展的环形孔口,可扩展的边缘支架或系列锚定倒钩从该孔口部署。
图5D显示安装在球囊导管32上的瓣膜元件30,所述球囊导管推进到基础支架24内的位置。瓣膜元件30包括人工瓣膜34和与其末端连接并从其末端突出的连接支架36。在其放射状地收缩或未展开的状态,连接支架36假定在远端方向向内圆锥形的逐渐变细。导管32伸展通过瓣膜元件30和在远端鼻锥38终止,该鼻锥具有圆锥形或铃形形状并覆盖连接支架36的逐渐变小的末端。尽管未显示,但是导管32延伸通过导入套管和瓣膜固定器。
当用于主动脉瓣置换术时,人工瓣膜34优选地具有三个提供流体咬合表面以替代天然瓣膜小叶功能的柔性小叶。在各种优选的实施方式中,瓣膜小叶可取自另一个人心脏(尸体)、母牛(牛)、猪(猪的瓣膜)或马(马(equine))。在其它优选的变型中,瓣膜部件可包括机械元件而不是生物组织。三个小叶由三个连接的柱支撑。沿着瓣膜部件的基底部分提供环。
在优选的实施方式中,人工瓣膜34部分包括商业上可获得的、不可扩展的人工心脏瓣膜,诸如从Edwards Lifesciences of Irvine,California得到的Carpentier-EdwardsPERIMOUNT Magna主动脉心脏瓣膜。在这个意义上,“商业上可获得的”人工心脏瓣膜是离开架子的(即适于独立的出售和使用)人工心脏瓣膜,其限定其中不可扩展的、不可收缩的孔口和具有缝合环,所述缝合环使用缝合线、通过心脏直视手术操作被植入。使用的进入到心脏的具体方法可不同,但在手术操作中将心脏停止跳动和打开,不同于心脏保持功能的搏动心脏操作。为了重申,术语“不可扩展的”和“不可收缩的”不应被理解为指完全刚性的和在尺寸上稳定的,只不过瓣膜不象一些提议的微创地或经皮递送的瓣膜的是可扩展的/可收缩的。
植入操作因此包括第一递送和在主动脉环处扩展基础支架24,然后连接包括到那里的瓣膜34在内的瓣膜元件30。因为瓣膜34是不可扩展的,所以使用常规的心脏直视技术典型地进行全部操作。然而,因为基础支架24通过简单的扩展而递送和植入,然后通过扩展,瓣膜元件30被连接到那里,都没有缝合,所以整个操作花了较少的时间。这种混合方法对熟悉心脏直视操作和商业上可获得的心脏瓣膜的外科医生还将更轻松。
而且,操作中相对小的改变加上证明的心脏瓣膜的使用将产生比严格地可扩展的远距离操作更容易的调节路径。即使该系统必须通过临床测试验证以满足FDA上市前批准(PMA)过程(与510k提交相反),瓣膜元件30的接受至少将由于商业的心脏瓣膜已被批准而被极大简化,,商业的心脏瓣膜诸如Magna主动脉心脏瓣膜。
人工瓣膜34具有以连接支架36形式的可扩展的连接机构,所述连接支架用于将瓣膜固定到基础支架24。尽管显示了连接支架36,但是连接机构可采取各种不同形式,仅仅消除对连接缝合线的需要和提供快速的连接方法。
在图5E中,瓣膜元件30已前进到主动脉环AA处和处于基础支架24内的期望的植入位置。人工瓣膜34可包括缝线能透过的环42,该环42期望地邻接主动脉环AA。更优选地,缝合环42位于环上方,或在主动脉环AA的最窄点上方,以便允许选择比环内放置的瓣膜更大的孔径。随着使用基础支架24的前述的环扩展,和环之上的放置,外科医生可选择具有较先前可想到的大一个或两个增量的瓣膜。如所提到的,人工瓣膜34是期望的具有缝合环42的商业上可获得的心脏瓣膜。球囊导管32已相对于瓣膜元件30前进以代替与连接支架36不接合的鼻锥38。可以看到导管30上的膨胀球囊40刚好超过连接支架36远端。
图5F显示导管32上的球囊40,其被膨胀以接近基础支架24扩展和展开连接支架36。期望使用受控的、增压的无菌生理盐水使球囊40膨胀。连接支架36在其圆锥形的收缩状态和其通常的管状的扩展状态之间转变。连接支架36和基础支架24之间的简单干扰可足以在基础支架内锚定瓣膜元件30,或相互作用的形状诸如突出物、钩、倒钩、织物等。
因为基础支架24在瓣膜元件30与其连接之前扩展,所以可使用较高强度支架(自身可扩展的或球囊可扩展的)结构。例如,可使用相对粗壮的基础支架24以将天然小叶推开,并且缺少的瓣膜元件30在高压基础支架部署期间不被损害或不被以其它方式不利地影响。基础支架24部署在身体管道之后,瓣膜元件30通过部署连接支架36连接到那里,该支架可以是稍微更轻,需要较小的扩展力。同样,球囊40可具有较近端扩展端大的远端扩展端,以便施加到连接支架36较施加到人工瓣膜34更多的力。以这种方式,人工瓣膜34和其中的柔性叶不遭受来自球囊40的高扩展力。实际上,尽管显示了球囊部署,但是连接支架36还可以是自身扩展型支架。在后者的结构中,鼻锥38适于在基础支架24内瓣膜元件30中定位之前保持连接支架36在其收缩的状态。
如上面所指出的,本文描述的基础支架能包括倒钩或其它组织锚形体以进一步将支架固定到组织,或将连接支架36固定到基础支架24。另外,通过球囊的扩展,倒钩可以是可部署的(例如,配置以伸展或放射状地向外推)。优选地,将连接支架36覆盖以促进向内生长和/或以减少瓣膜旁渗漏,诸如用达克龙管或类似物等。
图5G显示与鼻锥38在一起的导管32上瘪的球囊40,鼻锥38正被从瓣膜元件30内除去。最后,图5H显示本发明的完全部署的人工心脏瓣膜系统,包括在主动脉环AA内连接到基础支架24的瓣膜元件30。
图6是用于递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8是其组装图。改变的递送系统50的部件也显示在图9和10中。递送系统50包括在其远端具有球囊和在其近端具有珠孔塞54的球囊导管52。珠孔塞54提供接受卢尔连接器或其它这样的Y配件58的紧固件的近端连接56。前述的鼻锥38可与导管52的最远端连接,但更优选地与通过球囊导管52的中心腔插入的导线(未显示)连接。
导管52和鼻锥38通过具有近端部分62和远端部分64的中空手柄60。远端手柄部分64的远端牢固地与瓣膜固定器68的套66连接,其又与人工心脏瓣膜元件30连接。将参考图11A-11E给出瓣膜固定器68的细节。
期望手柄60的两个部分62、64由刚性材料诸如模制塑料(molded plastic)形成,并相互连接以形成相对刚性和伸长的管,用于操纵与其远端连接的人工瓣膜元件30。特别地,远端部分64可容易地连接到固定器套66,并且因此在手术前冲洗步骤期间提供用于操纵瓣膜元件30方便的工具。为了该目的,远端部分64具有连接到固定器套66的远端管状节段70和在其近端具有开口的扩大的近端节段72的特征,近端节段72接受近端手柄部分62的管状延长部分74。图6显示可在管状延长部分74的外部上提供的环形垫圈(O-ring)76,用于摩擦的过盈配合(frictional interference fit)以防止两个部分脱离。尽管未显示,但是远端管状节段70还可具有环形垫圈,用于牢固地连接到固定器套66,或可与车缧纹等连接。在一个优选的实施方式中,在近端手柄部分62内包装导管52上的球囊40,用于保护和容易操作。连接近端和远端手柄部分62、64因此“负载”系统50,以至于球囊导管52可被推进通过连续的腔,通往瓣膜元件30。
图9和10图解与图7中显示的相似的递送系统50,但该系统在近端和远端手柄部分62、64上具有悬臂梁齿形式的可选的连接器77,该悬臂梁齿咬合进在各自的接收孔中形成的互补凹处。同样,还能使用配件上的车螺纹,以及其它相似的简便办法。图9显示膨胀的以扩展瓣膜元件连接支架36的球囊40。
在优选的实施方式中,人工瓣膜元件30并入生物组织小叶而被包装和储存,与固定器68连接但是与其它导入系统50元件分开。典型地,将生物组织包装和储存在具有防腐剂溶液的罐中,用于长的贮存期限,而将其它元件干燥包装和储存。
当如图7-9中所看到的进行装配时,细长的腔(未编号)从Y配件58的近端延伸到球囊40的内部。Y配件58期望地包括内螺纹的连接器80,用于与吹入系统相连,或具有路厄配件84的侧端口82,或可以使用相似的简便办法用于球囊40的吹入。
图7和8显示导管52和连带结构相对于手柄60和其连带结构的两个纵向位置。在图7中显示的收缩的位置中,球囊40最初位于远端手柄部分64内。图7图解导入系统50的递送结构,在其中外科医生将人工瓣膜元件30从外面推进到邻近靶环的位置。鼻锥38在周围延伸并保护圆锥形的未部署的连接支架36的远端。在图5D中也看到该结构,虽然为了清除将固定器68除去。注意手柄60的近端连接56和近端之间的间距S。
如上面参照图5A-5H所解释的,外科医生将人工瓣膜元件30推进到瓣膜环处其期望的植入位置,然后推进球囊40通过瓣膜元件并使其膨胀。为了这样做,操作者将递送系统50从图7的收缩的结构转变成图8的部署结构,如箭头78所指的,球囊导管40向远侧移位以使鼻锥38与连接支架36脱离。注意近端连接56现在接触手柄60的近端,消除图7中指示的距离S。
应当理解,人工瓣膜元件30可被植入具有预先部署的基础支架24的瓣膜环,如上面所说明的,或没有基础支架24的瓣膜环。连接支架36可以是足够结实的以在缺少基础支架24时接近天然的小环(小叶切除或没有切除)直接锚定瓣膜元件30。因此,用于导入人工心脏瓣膜的系统50的描述在操作的情况中应被理解具有或没有预先部署的基础支架24。
进一步描述递送系统50的操作之前,瓣膜元件30和瓣膜固定器68的更详细的说明是必需的。图11A-11E显示安装在本发明的递送固定器68上的示例性瓣膜元件30的多个透视图和其他视图。如所提到的,瓣膜元件30包括具有与其流入端相连的连接支架36的人工瓣膜34。在优选的实施方式中,人工瓣膜34包括商业上可获得的现成的不可扩展的、不可收缩的商品化的人工瓣膜。任何数目的人工心脏瓣膜可以被改型以与连接支架36连接,因此适于在本发明的情况下使用。例如,人工瓣膜34可以是机械瓣膜或具有柔性小叶的瓣膜,合成的或生物假体的。然而,在优选的实施方式中,人工瓣膜34包括生物假体组织小叶86(图11A)。此外,如上面所描述的,期望人工瓣膜34是从Edwards Lifesciences of Irvine,California获得的Carpentier-Edwards PERIMOUNT Magna主动脉心脏瓣膜(例如3000TFX型)。
在制造过程期间,连接支架36优选地与瓣膜缝合环42的心室(或流入)面相连,在某种程度上保持缝合环的完整并且防止瓣膜有效孔口面积(EOA)的减小。期望地,连接支架36将以保持缝合环的外部轮廓的方式被连续地缝合到缝合环42。缝合线可经过支架骨架中的孔或孔眼,或经过织品覆盖物,所述织品覆盖物又被缝到骨架上。其它的连接方案包括从支架、系杆、尼龙搭扣(Velcro)、铆头模、胶粘剂等向内伸展的叉或钩。可选地,连接支架36可被更刚性地连接到人工瓣膜34内的刚性元件。因此,植入期间,外科医生可根据常规手术使缝合环42接近环固定在位置上。这给予外科医生熟悉能触知的反馈以确保已实现正确的患者假体匹配。而且,缝合环42接近环的流出侧放置有助于减小瓣膜元件30向心室移动的概率。
连接支架36可以是预先卷曲的、逐渐变细的316L不锈钢球囊可扩展的支架,一旦植入在基础支架24内,期望被聚酯套筒88覆盖以有助于密封阻止瓣膜旁渗漏和促进组织向内生长(参见图5F)。连接支架36在图11A-11E逐渐变细的收缩的形状之间向图5F和也图10中显示的其向外展开扩展的形状转换。
连接支架36期望地包括连接到三个大体轴向延伸的支柱92的多个锯齿状或其它方式成角的、蛇形或网样的杆90。如下面将要看到的,支柱92期望具有一系列平等间隔的孔的特征,在合适位置容纳缝线的聚酯套筒88可被锚定到这些孔。如图5F中所最佳看到的,当被扩展时,支架36向外张开并接近基础支架24的内表面紧密地接合,并具有与基础支架基本相同的轴长度。可提供锚定装置诸如倒钩或来自连接支架36的其它突出以加强连接支架和基础支架24之间的摩擦支持。
应当理解,连接支架的具体结构——无论是否具有直的或曲线的支杆90——根据需要可被修改。有多种支架设计,如下面参考图12-17所描述的,其中任何一个潜在地可以是适合的。同样,尽管优选的实施方式并入球囊可扩展的连接支架36,但是自身扩展支架能被某些修改替代,主要到递送系统。相同的弹性和设计当然适用于基础支架24。在优选的实施方式中,期望基础支架24和连接支架36是可塑地可扩展的以为瓣膜34提供更坚固的锚定物;首先到具有或没有天然小叶的环,然后是两个支架之间。使用球囊或如下面所描述的机械扩张器可扩展支架。
仍然参考图11A-11E,固定器68包括前述的近端套66和其较薄的远端延长部分94,该部分形成固定器的中心部分。在中心延长部分94周围圆周地等距地隔开并从那里向外放射状地突出的三条腿96a、96b、96c包括内部的支杆98和外部的接合架100。人工瓣膜34优选地包括多个、典型地三个、以流出的方向突出的接合点102。尽管未显示,但是接合架100优选地并入凹陷,在所述凹陷之中安装接合点102的尖端。
在一个实施方式中,固定器68由刚性的聚合物,诸如Delrin或透明的聚丙烯形成以增加植入操作的可见性。如图11E中所最佳看到的,固定器68显示腿96a、96b、96c之间的开口以给外科医生提供瓣膜小叶86的良好的可见性,腿的透明性进一步促进可见性并允许光通过那里透射以使阴影最小。尽管本文未详细描述,图11E也图解腿96a、96b、96c中的一系列通孔,允许连接缝线以经过人工瓣膜34中的织物和横越每条腿中的切割引导。如本领域所知的,当期望时,切断连接到固定器68并经过瓣膜的中等长度的缝线允许固定器没有瓣膜进行牵拉。
图11C和11D图解有一点改变的来自图11A和11B中显示的连接支架36,其中支杆90和轴向伸展的支柱92被更好地限定。特别地,支柱92较支杆90更宽一点和更结实,因为后者提供给支架36从显示的圆锥形形状扩展到更管状的结构的能力。同样,大体圆形的加强环104邻接瓣膜缝合环42。支柱92和环104都进一步包括一系列的通孔106,该通孔可用于使用缝线等将聚酯边缘88固定到支架36。以下还描述连接支架36的多个变型。
图12A-12B图解通常是扩展形状的扁平结构(12A)和管状结构(12B)中示例性的连接支架36。如所提到的,网样的支杆90和加强环104连接三个大体是轴向延伸的支柱92。多个均匀间距的孔106提供锚定物,用于容纳聚酯套筒88(参见图11B)在合适位置。在图解的实施方式中,网样的支杆90还包括一系列轴向延伸的支杆108。连接到瓣膜缝合环并被加强环104限定的连接支架36的上端跟着弓形的波谷110和峰12交替的波浪形路径。如从图11C所看到的,示例性的人工瓣膜34具有波浪形的缝合环42,连接支架36的上端与其符合。在优选的实施方式中,支架36的几何形状与波浪形的缝合环42的几何形状相匹配。当然,如果人工瓣膜的缝合环是平面的,那么连接支架36的上端也将是平面的。还应指出,图12B的管状型式是扩展的结构的说明,尽管球囊40可过度扩展支架36的游离(下)端,以至于它终止处于轻微的圆锥形。
图13A和13B分别显示又在扁平和管状结构中的可选的连接支架120。如第一实施方式,连接支架120包括在一系列轴向延伸的支杆124之间延伸的网样的支杆122。在该实施方式中,所有的轴向延伸的支杆124是基本上相同的细的横断面大小。支架120的上端或连接端又包括加强环126,尽管该型式被一系列由间隙分开的短长度中断。上端限定多个交替的波谷128和峰130,加强环126的长度限定峰。轴向延伸的支杆124与支架120上端的圆齿状的形状是同相的,并且与峰和波谷的中间是相符的。
组成加强环126的长度之间的间隙允许支架120与许多不同尺寸的人工瓣膜34匹配。即,支架120的大部分是可扩展的,具有可变的直径,和在加强环126中提供间隙允许上端也具有可变的直径,以便它能被成型以匹配相应的缝合环的尺寸。这减少制造成本,因为相应尺寸的支架不需要用于每个不同尺寸的瓣膜。
图14是另外可选的与连接支架120非常相似的连接支架132的平面图,包括在一系列轴向延伸的支杆136之间连接的网样的支杆134,并且上端被由一系列短长度支杆形成的加强环138限定。与图13A和13B的实施方式相比,波浪形的上端的峰具有与支杆相反的间隙。表示这的另一个方法是轴向延伸的支杆136与支架132上端的圆齿状的形状异相,并且与峰和波谷的中间不一致。
图15图解示例性的连接支架140,其同样具有在轴向延伸的支杆144之间的可扩展的支杆142,和上加强环146。轴向延伸的支杆144与支架上端的峰和波谷同相。加强环146在较早描述的这样的环之间是十字形,因为它在其周围是连续的,但也具有可变的直径。即,环146包括一系列固定长度的支杆148长度,该固定长度由可变长度的较细的桥部分150连接。桥部分150每个由这样半径形成,以便它们可以被变直(变长)或弯曲(压缩)得更多。一系列孔152也在支架142的上端形成,当将支架固定到相应人工瓣膜的缝合环时提供缝线或其它附着装置的锚定点。
在图16中,可选的连接支架154与图15的支架140完全相同,尽管轴向延伸的支杆156与波浪形的上端的峰和波谷异相。
图17显示关于连接支架160的另外进一步的变型,其具有一系列连接轴向延伸的支杆164的可扩展的支杆162。如图12A和12B中显示的型式,网样的支杆162也包括一系列轴向延伸的支杆166,尽管这些杆比主轴向支杆164细。加强环168也较网样的支杆162更厚,并具有在每个波谷中的一个或多个间隙170的特征,以至于该环是不连续和可扩展的。轴向延伸的支杆164、166上的倒钩172、174可用于在连接支架160和基础支架之间加强保留,它与该基础支架相配合,或在没有基础支架的情形与环形组织相配合,如上面所说明的。
如上面所提到,本文描述的两元件瓣膜系统利用外部或基础支架(诸如基础支架24)和具有内部或瓣膜支架(诸如连接支架36)的瓣膜元件。瓣膜和其支架前进到预先锚定的外部支架的腔,并且瓣膜支架扩展连接两个支架并将瓣膜锚定到其植入位置中。重要的是内部支架和外部支架被圆周地和轴向地正确定位以使支架之间随后的相对运动最小。实际上,对于主动脉瓣置换术的主要应用,瓣膜接合的圆周位置相对于天然的接合是非常重要的。上面显示和描述了与瓣膜元件相连的连接支架的许多变型。图18-20图解示例性的基础支架和两个支架之间的配合。
图18A和18B显示基础支架180的示例性的实施方式,该基础支架包括多个放射状地可扩展的支杆182,该支杆在多个大体轴向延伸的支杆184之间延伸。在图解的实施方式中,支杆182在支杆184之间形成人字形模式,尽管也可使用其它结构诸如蛇形或菱形。放射状地可扩展的支杆182的顶行和底行并列排列以便形成多个三角形的峰186和波谷188。轴向支杆184与波谷188同相。
图18A的平面视图显示四个轴向的突出部分190,每个从轴向支杆184之一向上延伸。尽管显示了四个突出部分190,但是示例性的基础支架180期望地具有三个平均地圆周地间隔的突出部分,如图18B的管状型式周围所看到的,为基础支架提供定位标记。这些标记因此使外科医生更容易定位支架180,以至于标记与天然的接合点对准。此外,当瓣膜元件前进到基础支架180内,可见的突出部分190提供参考标记,以至于内部的支架可以被正确地定位到基础支架内。在这一点上,突出部分190可被涂成与支架180的剩余部分不同颜色,或在其上具有不透射线的指示物。
中间支杆182的顶行之上的突出部分190的长度也可被标上刻度以帮助外科医生轴向地定位支架180。例如,可测定突出部分190的尖端至天然的环水平的距离,并能在特定的解剖学标志诸如冠状动脉口水平正下方定位突出部分190。
图18A中的波浪形的虚线192表示内部或连接支架140的上端,其显示在基础支架180上重叠的模型中。就这一点而论,虚线192也表示波浪形的缝合环,它具有缝合环可以是平面的重复,以至于连接支架的上端也是平面的。连接支架140包括轴向延伸的支杆,该支杆与支架圆齿状的上端的各自的峰和波谷是同相的。在示例性的结合中,连接支架(虚线192)圆齿状的上端的峰与具有突出部分190的轴向的支杆184旋转地对应(是同相)。因此,因为连接支架140轴向的支杆与其上端的峰是同相的,所以它们也与基础支架180的轴向的支杆184也是同相的。相反地,连接支架可具有与其上端的峰异相的轴向的支杆,在这种情况下,两个支架各自的轴向的支杆也是异相的。
图19显示可选的基础支架200,其一般具有与图18A的基础支架180相同的元件,但是轴向的支杆184在中间支杆182的外侧行的峰186之间延伸。在较早的实施方式中,轴向的支杆184在波谷188之间延伸。图16的连接支架154显示在基础支架200之上重叠的模型中以图解两个支架的轴向的支杆现在如何异相以增加它们之间的连结。
支架200也显示中间支杆182的不同行。具体地,第一行202a限定具有相对浅的角的V,第二行202b限定具有中等角的V,第三行202c限定具有更锐角的V。当被扩展时,支杆182在这些行中形成的不同的角有助于将支架形成圆锥形的形式。距人工瓣膜最远的第三行202c中的支杆具有扩展的最大能力以适应支架折叠的圆锥形向扩展的管状形状转变。
本领域的技术人员将理解有许多方法来增加两个支架之间的保留。例如,两个支架上的网样的可扩展支杆的峰和波谷可被异相或同相定位。在优选的实施方式中,两个支架的峰和波谷是异相的,以便内部支架的扩展引起它的峰向外变形成为外部支架的波谷,并由此在其间提供连结结构。上面描述的变型提供许多该配合的改变。
另外,一个或两个支架上的轴向的突出部分能被弯曲以提供与其它支架的干扰(需要与过盈配合一致吗)。例如,图12A中显示的支架36中的轴向支杆108的下端可通过非均匀形成的球囊的扩展向外弯曲,以至于它们在外部支架内在空隙中延伸。同样,图17的实施方式图解可通过向外弯曲与相应基础支架形成过盈的倒钩172、174。从一个位置转变到另一个位置以增加两个支架之间保留的支杆末端或倒钩可被机械弯曲推动,诸如用球囊或通过安装到身体内之后的自动形状改变。即,一些形状记忆合金诸如镍钛诺可被设计以在温度改变之后经历形状改变,以至于它们在室温假定第一形状,在体温时是第二形状。
图20图解增加两个支架之间保留的简化的装置。内部瓣膜支架210在外部基础支架212内配合,以至于其低端214在外部支架下延伸。通过球囊在支架210内的过度扩展,引起下端214弯曲或向外卷以防止外部支架内的内部支架相对向上运动。
图21是用于机械扩张器224内递送和扩展基础支架222的装置220的透视图。在图解的实施方式中,扩张器224包括多个可扩展的指状物226,在指状物之上基础支架22被卷曲。装置220包括注射器样的器具,其包括桶230,桶内柱塞(plunger)232线性地滑动。指状物226被轴向固定但可相对于桶230绕轴旋转或伸缩。柱塞232的远端具有外部直径,该直径大于可扩展的指状物226的内表面限定的直径。优选地在指状物226内部上有近端的引入斜面,以至于柱塞232的远端运动相对于桶230逐渐地用凸轮带动指状物向外。柱塞232的两个位置显示在图21和23中。
作为柱塞232的简单线性运动的替代,桶230内也可以是车螺纹地容纳的。更进一步地,柱塞232可以由相互自由旋转的两部分形成,在桶230内近端部分是车螺纹地接受的,而远端部分相对于桶不旋转,仅仅用凸轮带动指状物226向外。更进一步地,可使用机械联动代替凸轮系统作用,由此铰合在一起的杠杆产生指状物226的向外运动。并且更进一步地,可利用使用具有安装在球囊外部上机械部分的膨胀球囊的混合型式。本领域的技术人员将理解关于该机构的很多变型是可能的,重点是球囊扩展不仅仅是手段。
期望地,指状物226具有成形的外形,以至于它们将基础支架222扩展成更好地适合心脏瓣膜环的特定的形状。例如,基础支架222可被扩展成具有较宽的上端和下端和较小的中间部分的中凹形,和/或上端可被形成三叶形以更好地适合主动脉窦。在后者的情况下,三叶形对植入之后定位基础支架222以及定位被接受在其内的瓣膜元件的连接支架是有用的。
在另一个有利的特征中,在前述的图中图解的两元件瓣膜系统提供装置和方法,其与去除天然小叶之后被缝合到组织的置换瓣膜相比显著减少手术操作的时间。例如,图5-9的支架24可被快速地部署,瓣膜元件30也可被快速地与支架相连。这减少体外循环需要的时间,由此显著减少对患者的危险。
除了加速植入过程,本发明具有预先锚定的支架,瓣膜和其支架安装在该支架内,允许环被扩展以接纳较可能的更大的瓣膜。具体地,临床研究已显示左心室流出道(LVOT)可被球囊可扩展的支架显著地扩展并保持正常的功能。在该情况中,“显著地扩展”LVOT指扩展至少10%,更优选地在约10-30%之间。按绝对值计算,根据正常的孔径尺寸LVOT可被扩展1.5-5mm。环的这种扩展产生增加手术植入的人工瓣膜尺寸的机会。本发明利用球囊可扩展的基础支架,和球囊可扩展的瓣膜支架。这两个支架的结合允许在主动脉环和在主动脉环正下方、在人工瓣膜的流入端扩展LVOT。在基础支架外侧和LVOT之间产生的过盈配合固定没有小拭子的瓣膜或保证占据空间,由此允许最大可能的瓣膜尺寸的放置。较将用常规手术其它方式获得更大的瓣膜尺寸增加容量血流量和减小通过瓣膜的压力梯度。
本领域的技术人员将理解,本发明的实施方式提供重要的新的装置和方法,其中瓣膜可以快速和有效的方式被安全地锚定到体腔。本发明的实施方式提供在手术操作中植入人工瓣膜而不需要外科医生将瓣膜缝合到组织的装置。因此,手术操作时间显著地减少。此外,除了为瓣膜提供基础支架,该支架可用于保持天然的瓣膜处于扩大的状态。因此,外科医生不必除去天然小叶,由此进一步减少操作时间。
还将理解的是本发明提供改良的系统,其中瓣膜部件可以以更快和有效的方式被置换。更具体地,不必为了去除瓣膜而切断任何缝线。而是瓣膜部件可与支架(或其它基础支架)分离,并且新的瓣膜部件被连接到正确位置。当使用生物组织瓣膜或具有有限的设计寿命的其它瓣膜时,这是重要的优点。
虽然本发明已在其优选的实施方式中被描述,但是将理解,已被使用的词语是描述的词语而不是限制的词语。因此,在所附权利要求内、不背离本发明的真正范围,可作出改变。
Claims (27)
1.人工心脏瓣膜系统,包括:
基础支架,其适合接近心脏瓣膜环锚定和在其中限定孔口;和
瓣膜元件,其包括不可扩展的、不可收缩的人工瓣膜,所述瓣膜元件进一步包括从其流入端延伸的可扩展的连接支架,所述连接支架具有用于递送到植入位置的收缩状态和配置用于向外连接到所述基础支架的扩展状态,其中所述人工瓣膜包括流入端周围的缝合环,并且其中所述连接支架包括孔眼,穿过该孔眼所述连接支架的流出端被连续地缝合至所述缝合环。
2.权利要求1所述的系统,其中所述基础支架是可扩展的,并且具有用于递送到邻近心脏瓣膜环的植入位置的收缩状态,和大小适于接近所述心脏瓣膜环接触和锚定的扩展状态。
3.权利要求2所述的系统,其中所述基础支架是可塑性地可扩展的。
4.权利要求1所述的系统,其中所述连接支架是可塑性地可扩展的。
5.权利要求1的系统,其中所述人工瓣膜包括具有缝合环的商业上可获得的瓣膜,并且其中所述连接支架与所述缝合环相连。
6.权利要求1所述的系统,其中所述连接支架的所述收缩状态是圆锥形的,在远端方向向内逐渐变细。
7.权利要求6所述的系统,其中所述连接支架包括多个放射状地可扩展的支杆,其中至少一些支杆成行排列,其中最远的行具有从所述收缩状态扩展到所述扩展状态的最大能力。
8.权利要求1所述的系统,其中所述连接支架包括多个放射状地可扩展的支杆,并且距所述人工瓣膜最远的行具有交替的尖点和凹陷处,并且其中所述基础支架包括孔,在该孔中所述连接支架的尖点可突出以连结所述两个支架。
9.权利要求1所述的系统,其中所述基础支架包括多个在轴向定位的支杆之间的放射状地可扩展的支杆,所述轴向定位的支杆中至少一些具有区分所述支架周围的位置的上突出。
10.用于递送和植入人工心脏瓣膜系统的系统,包括:
基础支架,其配置为被推进到邻近心脏瓣膜环的植入位置,并且被锚定到所述心脏瓣膜环;
瓣膜元件,所述瓣膜元件包括不可扩展的、不可收缩的人工瓣膜,所述瓣膜元件进一步包括从其流入端伸展的可扩展的连接支架,所述连接支架具有用于递送到植入位置的收缩状态和配置用于向外连接到所述基础支架的扩展状态;
其中所述瓣膜元件被配置为以其收缩状态与所述连接支架一起被推进到邻近所述基础支架的植入位置;和
其中所述连接支架被进一步配置为扩展到所述扩展状态,与所述基础支架接触并相连接,并且其中所述人工瓣膜包括流入端周围的缝合环,并且其中所述连接支架包括孔眼,穿过该孔眼所述连接支架的流出端被连续地缝合至所述缝合环。
11.权利要求10所述的系统,其中所述基础支架是可塑性地可扩展的,并且其中所述可扩展的基础支架被配置为以收缩状态被推进到所述植入位置;和可塑性地扩展到扩展状态,与所述心脏瓣膜环接触并锚定到所述心脏瓣膜环,在该过程中增加所述心脏瓣膜环的所述孔尺寸至少10%。
12.权利要求11所述的系统,其中所述瓣膜元件的所述人工瓣膜被选择以具有与所述心脏瓣膜环增加的孔尺寸匹配的孔尺寸。
13.权利要求11所述的系统,其中所述基础支架被进一步配置为安装在机械扩张器上,和使用所述机械扩张器部署所述基础支架在所述心脏瓣膜环。
14.权利要求10所述的系统,其中所述瓣膜元件被安装在具有通过其的近端插孔和腔的固定器上,和其中所述固定器被安装在具有通过其的腔的手柄的远端上,所述系统进一步包括球囊导管,其被配置为穿过所述手柄和所述固定器的腔并且在所述瓣膜元件内,以及球囊,其被配置为在所述球囊导管上膨胀以扩展所述连接支架。
15.权利要求14所述的系统,其中安装在所述固定器上的所述瓣膜元件与所述手柄和所述球囊导管分开包装。
16.权利要求14所述的系统,其中所述连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较其近端扩展端更大的远端扩展端,以便施加到所述连接支架的膨胀偏转较施加到所述人工瓣膜的更大。
17.权利要求10所述的系统,其中所述连接支架的收缩状态是圆锥形的,和其中所述连接支架包括多个放射状地可扩展的支杆,其中至少一些支杆成行排列,其中距所述人工瓣膜最远的行具有从所述收缩状态扩展到所述扩展状态的最大能力。
18.权利要求10所述的系统,其中所述连接支架包括多个放射状地可扩展的支杆,其中距所述人工瓣膜最远的行具有交替的尖点和凹陷处,其中所述连接支架的远端被配置为较所述连接支架的其余部分更多扩展,以便距所述人工瓣膜最远的行中的所述尖点向外突出进入所述基础支架的口中。
19.权利要求10所述的系统,其中所述基础支架和所述连接支架在轴向定位的支杆之间具有多个放射状地可扩展的支杆,并且其中定位所述连接支架以便其轴向定位的支杆与所述基础支架的那些支杆异相以增加其间的保留。
20.权利要求10所述的系统,其中通过可塑性地扩展所述基础支架,所述心脏瓣膜环的所述孔尺寸被增加1.5-5mm。
21.用于递送人工心脏瓣膜的系统,包括:
瓣膜元件,其包括不可扩展的、不可收缩的人工瓣膜,所述瓣膜元件进一步包括从其流入端伸展的可扩展的连接支架,所述连接支架具有用于递送到植入位置的收缩状态以及扩展状态;
连接到所述瓣膜元件近端的瓣膜固定器;
具有球囊的球囊导管;和
手柄,其被配置为与所述瓣膜固定器近端相连并且具有用于所述导管通过的腔,所述球囊向远端伸展通过所述手柄、经过所述固定器并通过所述瓣膜元件,并且其中所述人工瓣膜包括流入端周围的缝合环,并且其中所述连接支架包括孔眼,穿过该孔眼所述连接支架的流出端被连续地缝合至所述缝合环。
22.权利要求21所述的系统,其中所述人工瓣膜包括具有缝合环的商业上可获得的瓣膜,和其中所述连接支架与所述缝合环相连。
23.权利要求21所述的系统,其中所述连接支架的所述收缩状态是圆锥形的,在远端方向向内渐缩。
24.权利要求21所述的系统,其中所述连接支架的所述收缩状态是圆锥形的,在远端方向向内渐缩,其中所述球囊导管进一步包括其远端末端上的大体圆锥形的鼻锥,所述鼻锥伸展通过所述瓣膜元件并接合处于收缩状态的所述连接支架的远端。
25.权利要求21所述的系统,其中所述手柄包括近端部分和远端部分,其可串联连接在一起以形成连续的腔,和其中使所述远端部分适合连接所述固定器的插孔以在与所述近端手柄部分连接之前使用所述远端部分实现所述瓣膜元件的手动操作。
26.权利要求25所述的系统,其中将所述球囊导管和近端手柄部分与所述球囊一起包装在所述近端部分腔内。
27.权利要求21所述的系统,其中将安装在所述固定器上的所述瓣膜元件与所述手柄和所述球囊导管分开包装。
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CN1961845A (zh) * | 2005-11-09 | 2007-05-16 | 温宁 | 人工心脏支架瓣膜 |
CN1799520A (zh) * | 2006-01-16 | 2006-07-12 | 孔祥清 | 经皮主动脉瓣置换装置 |
CN101081181A (zh) * | 2006-06-02 | 2007-12-05 | 同济大学 | 一种可用于先天性心脏病的治疗装置及其使用方法 |
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