CN1849102A - 用于主动脉瓣狭窄治疗中通过动脉输送的可植入式修复装置及其方法 - Google Patents
用于主动脉瓣狭窄治疗中通过动脉输送的可植入式修复装置及其方法 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
Abstract
所述修复装置用于病人心脏的主动脉瓣膜中治疗主动脉瓣狭窄,该修复装置具有用于通过动脉输送的压缩状态并且可以展开至用于植入的展开状态,该修复装置包括:可展开的金属基座和衬入金属基座内表面的内膜,其中金属基座构成为可以以修复装置的展开状态植入主动脉瓣膜的主动脉瓣环中。在修复装置的展开状态中,内膜伸入主动脉中并且为扩散式锥形结构,其中它的直径从其位于主动脉瓣环内的近端到其伸入主动脉中的远端逐渐增加,以至于在心脏收缩期间产生进入主动脉的非紊态血液流,同时伴有内膜远端的压力恢复。优选的是,远端包括同时植入的修复瓣膜,但是这种修复瓣膜也可以单独植入主动脉中。另外还说明了植入这种修复装置的优选方法。
Description
技术领域
本发明涉及可植入式修复装置。本发明特别用于可以通过动脉输送植入病人心脏的主动脉瓣中用于治疗主动脉瓣狭窄的修复装置中,因此下面将就该应用场合说明本发明。但是,可以认识到,本发明也可以用于其它治疗,例如主动脉回流及其它瓣膜病变。本发明还涉及植入这种修复装置的方法。
背景技术
主动脉瓣狭窄是在心脏收缩期间由主动脉瓣的开放受限而引起从左心室流入主动脉的流出道阻塞。缩小的主动脉瓣开放面积(从正常的3cm2到严重病例中小于0.5cm2)导致瓣膜上的显著压降,并且正常的心脏输出和主动脉压力有以增加的心室压力为代价才能得到保持。左心室不得不产生的高压导致增加的室壁张力和心肌需氧量。适应性处理,如肥大(补偿性增加肌肉质量)允许心脏在一段时间内承受这一增加的压力负荷,但是最终泵衰竭(pumpfailure)不可避免。
在多数病例中(在年龄高于65岁的所有病人中超过90%)主动脉瓣狭窄是由最初正常瓣膜的逐步纤维化和钙化变性、高脂蛋白血症所促成的过程、动脉高血压和衰老(后天性钙化的主动脉瓣狭窄)所引起。患有严重主动脉瓣狭窄和呼吸短缺的病人的平均存活时间低于两年。因为在很大一部分病例中死亡可能突然发生,一些研究人员建议,如果是理想的手术候选人,甚至在无症状的病人中也要进行预防性手术。
在患有单独的主动脉瓣狭窄的挑选病人组中手术结果比较好。这种病人的手术死亡率大约为5%。但是,患有明显的主动脉瓣狭窄的大多数人年龄都在70多岁和80多岁。这些病人通常具有多个共病危险因素,如冠状动脉疾病、脑血管疾病、全身性动脉粥样硬化、肾衰竭或糖尿病。因此,手术死亡率和致病率很高。而且,如果用机械修复瓣膜置换钙化的主动脉瓣膜,那么就必须防止凝血以减小血栓栓塞性并发症,这将使病人承受增大的严重出血危险。生物修复瓣膜的植入在早期通常为首选,但是,因为瓣膜需要安装于其上的缝合环减小了瓣膜本身可以利用的空间,因此手术植入的生物瓣膜可能具有并非最理想的血液动力学外形。这一点对于女人会带来特别的问题,这是由于(因为较小的心脏尺寸而不得不使用的)尺寸较小的生物修复瓣膜可能导致明显的剩余流出阻塞。
因为岁数大的病人在心肺旁路的心内手术中所承受的巨大危险,包括死亡、致残性中风、呼吸及肾脏并发症,就希望使用气囊导管的狭窄瓣膜扩张为手术提供一种选择。不幸的是,因为气囊扩张的直接结果并非最理想,并且实际上在所有病人中器官狭窄的回弹会在几个星期和几个月内再次出现,因此,结果与没有经历手术的病人一样差。气囊扩张因此被认为仅仅适合于患有明显手术禁忌征候的病人或者作为“过渡过程”。
最近,类似于支架在冠状动脉中的应用,已经有人提出使用瓣膜支架以便于获得足够大的瓣膜面积并且避免弹性回弹和再次狭窄。Spencer等人(美国专利6730118)、Andersen等人(美国专利5840081)和Gabbay(PN4759758)都说明了一种特定设计的瓣膜支架,其设计用于通过动脉放置。Cribier等人在WO98/29057中说明了一种可收缩的支架,其具有通过圆周缝合与其连接的瓣膜。网/瓣膜系统经由可充气的气囊放置。在1992年,Andersen等人报道了他们对于缝合在可展开不锈钢支架中的可折叠猪主动脉瓣的经历。瓣膜支架被安装在18至22mm气囊导管上并且植入肺部位置,其中气囊导管前端装载在16F Mullins长鞘管中,完全置换肺尖(或瓣叶),这些肺尖随着支架的完全放置而被压在支架和肺部动脉壁之间。但是,当在主动脉位置采取该方法时,这可能导致冠状动脉闭塞,而这对于病人是致命的。
即使在支架没有横过主动脉瓣环的整个面积放置时,位于二尖瓣前尖(或瓣叶)的心室一侧的动脉粥样化沉积物可能被推在冠状动脉口上,导致严重的冠状阻塞或者栓塞。为了能够放置相当大的支架而对严重钙化主动脉瓣膜的重度膨胀还可能导致瓣膜的钙沉积物的栓塞或者瓣膜的撕裂,从而导致明显的主动脉回流。此外,很大的支架一瓣膜还可能与周围结构,如二尖瓣前叶干涉(导致对其损伤或者破坏其功能),并且如果伸入左心室流出道,就可能与室间隔基部干涉,其在明显的主动脉瓣狭窄中通常会变得肥大。
发明内容
本发明的一个目的是提供另一种修复装置,其能够通过动脉输送并且特别适用于主动脉瓣狭窄的治疗。本发明的另一个目的是提供一种修复装置,其用于植入形成于人体通道壁中的孔口中并且能够经由人体通道输送。本发明另外的目的是提供植入这种修复装置的方法。
根据本发明的一个方面,它提供了一种用于病人心脏的主动脉瓣膜中治疗主动脉瓣狭窄的修复装置,该修复装置具有用于通过动脉输送的压缩状态并且可以展开至用于植入的展开状态,该修复装置包括:可展开的金属基座和衬入金属基座内表面的内膜,其中金属基座构成为可以以修复装置的展开状态植入主动脉瓣膜的主动脉瓣环中;其特征在于,修复装置的展开状态中的内膜伸入主动脉中并且为扩散式锥形结构,其中它的直径从其位于主动脉瓣环内的近端到其伸入主动脉中的远端逐渐增加,以至于在心脏收缩期间产生进入主动脉的非紊态血液流,同时伴有塑料内膜远端的压力恢复。
因此,本发明认识到,可植入式主动脉瓣膜支架的最大孔口面积必然受限于解剖学和病理学局限性以及随后对于放置安全性的考虑。因此本发明的目的在于减小在修复装置的任何给定横截面过流面积上的永久压力损失。甚至对于尺寸相对较小的修复装置,这也允许获得合理的血液动力学外形(低压力梯度),而对于更大的装置还优化血液动力学外形(甚至进一步降低压力梯度)。本发明因此通过使出口几何形状为流线型而实现压力恢复,以便于如文丘里(venturi)流量计那样避免紊流的产生和动能损耗。
根据所述优选实施例中的其它特征,在修复装置的展开状态中,扩散式锥形结构的内膜具有直径为5至20mm的近端和直径为15至30mm的远端,并且具有15至45mm的长度。另外,内膜的近端包括位于主动脉瓣环内部的具有同一直径的短直部分,其有效避免通过内膜的流动分离。优选的是,短直部分具有2至10mm的长度。
该装置因此可以以各种尺寸设置,以适应不同的修复尺寸(例如,12至29mm的生物修复瓣膜)以至于具有所有可能高度和人体表面积的病人都可以得到治疗。
根据本发明的另一个方面,它提供了一种修复装置,其用于植入形成于人体通道壁中的孔口中,该修复装置具有用于经由人体通道输送到植入地点的压缩状态,并且可以展开至用于植入孔口中的展开状态;该修复装置包括:构成为可以容纳在孔口中的可展开金属基座以及两个环形夹,这两个环形夹由金属基座携带并且在金属基座的展开状态中可以与壁的相对面接合用于将金属基座夹在孔口内。在所述优选实施例中,两个环形夹中每个都包括指状物的环形阵列。
如下面更具体地说明,这种结构特别适用于植入病人心脏的主动脉瓣环中,因为与需要显著扩张主动脉瓣环的修复装置相比它减小了阻塞或闭塞冠状动脉的可能性。
另外如下面更具体地说明,该修复装置还可能包括用于与金属基座一起植入的修复瓣膜;作为选择,可以在单独的手术中通过动脉输送和放置修复瓣膜。
根据本发明的另一个方面,它提供了一种方法,其用于将上述修复装置植入形成于体腔壁中的孔口中,包括:将压缩状态中的修复装置引入导管中,其中导管具有可以接合并且压缩两个环形夹的鞘管;将导管和修复装置经由人体通道输送到植入地点,使金属基座位于孔口中,并且两个环形夹位于形成有孔口的壁的相对侧;将鞘管移动到一侧释放一个环形夹使其展开,然后释放并展开另一个环形夹;并且从人体通道中取出导管和鞘管,留下植入孔口中的金属基座,而环形夹接合壁的相对侧。
根据本发明的另一个方面,它提供了另一种方法,其用于将上述修复装置植入形成于体腔壁中的孔口中,包括:将压缩状态中的修复装置引入导管中,其中导管具有可以与一个环形夹接合用于将其保持在压缩状态中的第一鞘管和可以与另一个环形夹接合用于将其保持在压缩状态中的第二鞘管;将导管和修复装置经由人体通道输送到植入地点,使金属基座位于孔口中,并且两个环形夹位于形成孔口的壁的相对侧;将第一鞘管移动到一侧以将一个环形夹释放至其展开状态;将第二鞘管移动到相对侧以将第二环形夹释放至其展开状态;并且从人体通道中取出导管和鞘管,留下植入孔口中的金属基座,而环形夹接合壁的相对侧。
因此可以看到,在两种方法中,通过环形夹与装置所植入的壁的相对面相接合而将装置植入。在两种情况下,也可能引起金属基座的少量扩张,但是其程度远远低于现有技术的气囊植入装置,其中现有技术的装置增大了阻塞或闭塞冠状动脉的危险。然而,根据所述优选实施例中的其它特征,优选的是,本发明的修复装置经由气囊导管输送,以至于稍微扩张金属基座至足以牢固接合主动脉瓣环的表面但是没有到达使其变形至增大阻塞或闭塞冠状动脉的危险的程度。
根据下面的说明将可以清楚理解本发明的其它特征和优势。
附图说明
在这里将结合附图仅仅出于示例的目的说明本发明,其中:
图1a、图1b和图1c是帮助说明由狭窄瓣膜所引起的健康问题以及由根据本发明构成的修复装置置换狭窄瓣膜口的优势的图示;
图2是显示根据本发明构成的修复装置的图示,该装置通过形成进入主动脉的非紊态血液流同时伴有修复装置远端的压力恢复来治疗上述健康问题;
图3是根据图2构成的修复装置的侧视图;
图4是三维视图,其更具体地显示了根据本发明的修复装置的一种优选结构;
图5是图4所示修复装置的侧视图;
图6是从心脏一侧观看的端视图,其显示了植入主动脉瓣环中的图4和图5所示修复装置;
图7是图4和图5所示植入的修复装置从主动脉一侧观看的透视图;
图8是不完全的详细视图,其显示了在修复装置的植入状态中环形夹接合瓣叶相对侧的方式;
图9显示了与图3中所示相似的修复装置,但是包括用于在植入时支撑修复装置远端的支架;
图10显示了被植入主动脉瓣环时图9所示修复装置;
图11显示了根据本发明的修复装置的另一种结构;
图12是三维视图,其显示了根据本发明构成的另一种修复装置;
图13是图12所示装置的侧视图;
图14显示了位于中间关闭(没有完全关闭)状态中的图12和图13所示修复装置;
图15a至图15h和图16a至图16f显示了用于植入根据本发明的两种修复装置的单鞘管法;和
图17a至图17f显示了用于植入根据本发明的修复装置的双鞘管法。
可以理解,上述附图和下面说明部分主要出于下面目的而提供,即方便对本发明的概念性特征及其各种可能的实施例,包括那些目前认为是优选的实施例的理解。为了清楚和简洁,这里并不企图提供通过常规技术和设计使本领域中的技术人员理解并且应用所述发明所需之外的更多细节。另外可以理解,所述实施例仅仅出于示例的目的,并且能够以这里所述实施例之外的其它形式和应用场合实施本发明。
具体实施方式
涉及的基本概念(图1至图3)
如上所述,本发明主要集中于将修复装置植入患病的主动脉瓣膜中用于治疗主动脉瓣狭窄。该装置设计为帮助血液压力恢复以至于降低左心室和主动脉之间的压力梯度,由此减轻心脏的工作负荷。图2示意性显示了根据本发明的修复装置的一种结构,并且图1a至图1c示意性显示了这种修复装置可以用于通过遭受明显主动脉瓣狭窄的主动脉瓣膜减轻心脏工作负荷的方式。
心血管系统中的流动调节原理与管道系统中的非常相似。主动脉压力和心脏输出由在主动脉和颈动脉中带有拉伸感受器的压力感受器系统调节。任何压力损失都将导致心脏输出的中枢诱发(centrally mediated)增加,直到再次达到预定的系统压力。
图1a因此示意性显示了从左心室LV通过主动脉口AO进入主动脉AA的血液流如何受到主动脉口AO中狭窄状况的影响。因此,这种狭窄状况明显减小了主动脉口AO的尺寸以至产生进入主动脉AA的紊流,这对进入主动脉的血压产生了很大的压力损失。这一压力损失由用于增加心室内压力的压力感受器系统检测到,由此在心室中产生增加的室壁张力,增加的心肌需氧量和最终的心脏衰竭。
如图1b中所示,当如图1a中所示的狭窄瓣膜口由具有相同狭口尺寸但是包括文丘里管结构,即具有扩散式锥形结构的修复装置置换时,就产生了进入主动脉的非紊态血液流,同时伴有装置远(宽)端的压力恢复。压力感受器系统因此将不会检测到压力损失,并因此不会增加左心室工作负荷以补偿这一压力损失。因此,将如图1a中所示的狭窄瓣膜用带有如图1b所示扩散式锥形结构的修复装置置换将减小左心室的工作负荷。
图1c示意性显示了当作用在如图1a所示的狭窄瓣膜上时和当这种瓣膜由带有如图1b所示扩散式锥形结构的修复装置置换时心脏负荷中的差别。出于示例的目的,图1c的图示是基于下面状况:心脏输出为5升/分钟;狭口的横截面面积为0.5cm2;需要的压力梯度为100mm汞柱;并且所给示例中压力感受器系统所需的主动脉压力为125。因此,在狭窄瓣膜(图1a)中产生的压头损失的显著降低将导致左心室中的血液压力在心脏收缩期间为220mm汞柱。但是,增加带有相同临界面积且具有图1b中扩散式锥形结构的修复装置将提供65mm汞柱的压力恢复,并且将在心脏收缩期间产生140mm汞柱的血液压力。实际上,压头损失从95mm汞柱降低至15mm汞柱。
图2中示意性显示的修复装置包括将要植入主动脉口AO中的具有圆形横截面的环形金属基座2、在其外端可以与主动脉瓣环中的瓣叶(尖端)的一个面接合的环形夹3和可以与瓣叶的相对面接合的另一个环形夹4。修复装置的基座末端部分2相对短直、具有同一直径,并且位于主动脉口内。修复装置的其余部分伸入主动脉AA中并且具有扩散式锥形结构,如附图标记5所示,其中它的直径从其位于心脏左心室内的近端PE到其位于主动脉内的远端DE逐渐增加。扩散式锥形部分5的锥度角(α)根据文丘里流的动力学流体原理确定,以至于产生进入主动脉的非紊态血液流,同时伴有修复装置远端的压力恢复。
因此,关于文丘里流的流体动力学众所周知,基座或狭口部分2的小直径增加了通过其中的流速,由此减小静态或横向压力;反之,扩散式锥形部分5的逐渐扩张减小流速,并由此增加静态或横向压力。这种结构产生层流或非紊态流,减小或消除扩散式锥形部分5中的流动分离,并由此减小修复装置的远端DE处的压头损失。
如下面更具体地说明,优选的是,修复装置在其远端DE带有修复瓣膜。目前可以获得几种商业上的修复性主动脉瓣膜系统,它们通常分为机械心脏瓣膜和生物心脏瓣膜。
为了适应不同尺寸和重量的病人,优选的是,展开状态中的修复装置应该具有如图3中所示的下面尺寸:近端PE的直径D1应该为5至20mm;远端DE的直径D2应该为15至30mm;从近端到远端的轴向长度L1应该为15至45mm;并且基座或狭口部分2的轴向长度L2应该为2至10mm。
狭口部分2的典型直径D1为13mm(只占成人平均流出道直径的2/3);典型长度L2为5mm;扩散式锥形部分5的典型长度(L1-L2)为18至20mm;并且典型角度α(变宽角,与直段的偏差)为12°至25°,因为12°的角度α为层流产生几乎完全的压力恢复。例如,如果直狭口部分2具有13mm的直径(横截面面积为140mm2),那么与该段相连并且在20mm的距离上以17°的角度α变宽的管将在其端部将具有25mm的直径(横截面面积为490mm2)。因此,尽管狭口尺寸(瓣膜内的直段)只有13mm的直径,该装置也将能够以有利的血液动力学特性在其远端(主动脉中)容纳25mm的生物修复瓣膜。
图4至图8所示的修复装置
如前所述,优选的是,根据本发明构成的修复装置在扩散式锥形部分5的远端DE还包括将要与修复装置一起植入的修复瓣膜。但是,可以预知的是,对于一些应用场合,可以不带有修复瓣膜而植入修复装置,并且在另一个随后的手术中将修复瓣膜植入修复装置下游的主动脉中。
图4至图8显示了一种包括修复瓣膜的优选修复装置结构。
因此,如图5所示截面图具体显示,所示的修复装置包括可展开的金属基座10(例如,为网状结构)以至于可以经由导管通过动脉输送到植入地点,在这种情况下,即患有主动脉瓣狭窄的主动脉瓣膜的主动脉瓣环或主动脉口。所示的修复装置还包括,例如由柔性聚合物或其它生物兼容性材料构成的内膜11,其衬入金属基座10的整个内表面。
所示修复装置的金属基座及其内衬11包括短直的狭口部分12,狭口部分12构成为植入主动脉口(图2中AO)中。修复装置还包括:与主动脉口一侧的瓣叶(尖端)的表面接合的环形夹13;与主动脉口的相对侧的瓣叶的表面接合的环形夹14;以及伸入主动脉AA中的扩散式锥形部分15。该结构使得扩散式锥形部分15从位于修复装置的近端PE的短狭口部分12到其远端DE直径逐渐增加,以便于产生通过修复装置进入主动脉的非紊态血液流,同时伴有远端的压力恢复,如上面关于图1a至图1c和图2中的图示所述。
所示修复装置的远端带有修复瓣膜16。优选的是,修复瓣膜16为由柔韧的聚合物膜构成的可收缩机械或生物瓣膜,其在心脏收缩期间有效开放修复装置的远端并且在心脏舒张期间将它关闭。例如,修复瓣膜16可以由与内衬11相同的材料构成并且沿着图5中附图标记17所示的连接线连接于此。
虽然可收缩的生物修复瓣膜为首选,但是,也可以使用其它修复瓣膜系统,如球笼式、盘笼式、倾斜盘、双叶式、止回阀等。另外可以预知,可以使用机械或合成修复瓣膜。
在所示修复装置的展开状态中,环形夹13、14每个由与主动脉瓣环相对侧的瓣叶(尖端)表面接合的指状物的环形阵列构成,如图6至图8中更具体地显示。因此,如图8中具体地显示,环形夹13包括可以与主动脉瓣环AO位于心脏左心室一侧的自体瓣叶表面18(图6)接合的指状物13a的环形阵列;并且环形夹14包括可以与主动脉瓣环位于主动脉一侧的自体瓣叶表面19(图7)接合的指状物14a的类似环形阵列。
任何合适的方法都可以用于将内膜或内衬11连接到金属基座10的内表面上。例如,这可以如下进行:通过使用长效的生物兼容性胶粘剂进行胶接;通过使用声能在塑料内膜11接触金属基座的地方将其软化而进行超声波焊接;或者通过注射模制聚合物材料以在其中嵌入金属基座。其它可能的方法包括其中将内膜机械锁定到金属基座上的机械锁定装置,或其中将内膜缝合到金属基座上的缝合技术。
如上面粗略地说明和下面更具体地说明,修复装置10构成为具有用于通过动脉输送的压缩状态并且可以展开至用于植入的展开状态。出于该目的,金属基座10,包括其扩散式锥形部分15及其环形夹13和14,可以为纯金属、金属合金或者它们的组合。内衬11可以为合适的生物兼容性聚合物或塑料材料。
可以使用的纯金属的例子包括钨、铂和钛。具有必需的物理特性的金属合金包括(但是不限于)不锈钢316和镍钛诺(镍钛),两者都具有生物兼容性并且商业上可以获得。例如,镍钛诺可以用于环形夹13和14以及扩散式锥形部分15,而另一种传统的金属支架材料,如不锈钢316可以用于基座或狭口部分12。涤纶通常用于覆盖镍钛诺装置,但是,其它合适的生物兼容性聚合物或弹性体材料可以用于内膜或内衬11。
图9、图10和图11所示的修复装置
图9显示了一种与上面关于图4至图8所述相似的修复装置,因此为了方便理解,相应的部件由相同的附图标记表示。图9中所示修复装置的主要区别在于提供了多个支撑元件20,其由金属基座10的远端DE携带并且可以与主动脉的内表面接合用于在主动脉内部支撑修复装置,具体地说,即其远端,如图10所示。
图11显示了一种修改,其中支撑元件与由附图标记30表示的金属基座,具体地说,环形夹34的夹紧指状物34a一体形成,所述指状物可以与主动脉瓣环中瓣叶的远(主动脉)侧接合。因此,由附图标记40表示的支撑元件也是环形阵列的形式,该环形阵列从修复装置的远端,从它们与金属基座30的锥形部分35的连接点41延伸到夹紧指状物34a。夹紧指状物34a因此可以与其狭口部分32所携带的夹紧指状物33a协同作用以将装置夹在主动脉口中。支撑元件40构成为接合主动脉的内表面,优选的是,接近修复装置的远端,以便于在修复装置植入主动脉瓣环时支撑该端部。当然,关键的是,它们构成为不会阻塞或闭塞主动脉瓣环附近的冠状动脉(如下面对图16f的说明中所述)。
支撑元件40可以由与金属基座30相同的材料构成,例如,镍钛诺。出于简化的目的,图11省略了内衬和修复瓣膜,分别为图5中的附图标记11和16。
图12至图14所示的修复装置
图12至图14显示了一种与上述装置有很大差别的修复装置,其不同之处在于金属基座只占据了安装在主动脉瓣环中的修复装置的狭口部分(图2中附图标记2);也就是说,图12至图14中由附图标记110表示的金属基座没有延伸到修复装置的扩散式锥形部分(图2中附图标记5)或者只构成其一部分。修复装置的扩散式锥形部分5(图2)只由图12至图14中的附图标记111表示的内膜占据,该塑料内膜还用作修复瓣膜。因此,在心脏收缩期间,内膜111开放并且呈现扩散式锥形结构,以至于产生进入主动脉的非紊态血液流,同时伴有内膜远端的压力恢复;反之,在心脏舒张期间,内膜111收缩以堵塞通过其中的流动。
只对应于将要植入主动脉瓣环中的修复装置的狭口部分(例如,图5中附图标记12)的金属基座110还包括两个指状物113、114的环形阵列,在其相对侧用于与主动脉瓣环中瓣叶的相对表面接合,并因此对应于图5中的环形夹13、14。
内膜111衬入金属基座110的内表面。它于是向金属基座的外部延伸以形成修复装置的扩散式锥形部分,以及由修复装置的远端携带的修复瓣膜(分别对应于图5中部分15和瓣膜16)。
内膜111还包括多个轴向延伸的支柱112,所述支柱在112a处枢轴安装到金属基座110上,以允许内膜在心脏收缩期间展开至其瓣膜开放状态以允许血液流过其中,同时呈现扩散式锥形结构,用于产生进入主动脉的非紊态血液流,同时伴有远端的压力恢复。支柱112还允许内膜111在心脏舒张期间收缩以便于有效堵塞通过其中的血液流,并且履行修复瓣膜的功能。图14显示了部分收缩状态中的内膜111。
加强支柱112可以由与金属基座110相同的金属构成,并且可以通过一体形成的铰链枢轴安装到基座上。作为选择,加强支柱112可以由不同材料构成,例如,由不同的金属或塑料构成,其足够坚硬以在心脏收缩期间在其瓣膜开放锥形结构中支撑内膜111,并且以任何合适的方式机械铰接到金属基座110上。
因此可以看到,图12至图14中所示的修复装置不仅用于调节从左心室流入主动脉的流动以产生上述进入主动脉的非紊态流,同时伴有压力恢复,而且用作在心脏收缩期间开放并且在心脏舒张期间关闭的修复瓣膜。
放置方法
如前所述,本发明的修复装置设计用于植入形成于人体通道壁中的狭口中。因此,它构成为具有用于经由人体通道输送到植入地点的压缩状态并且可以在植入地点展开至用于植入狭口中的展开状态。上述本发明的优选实施例设计用于植入病人心脏的主动脉瓣环中,并因此构成为通过动脉输送到主动脉瓣环并且在主动脉瓣环中展开用于植入其中。
下面将关于图15a至图15h和图16a至图16f说明单鞘管放置法;并且关于图17a至图17h说明双鞘管放置法。
单鞘管放置法
图15a至图15h示意性显示了一种使用单个鞘管放置,例如图2中所示的修复装置的方法;而图16a至图16f显示了用于放置具有如图11中所示结构,即包括支撑元件40的环形阵列的修复装置的方法。
在图15a至图15h所示的单鞘管法中,由附图标记PD一般表示并且具有图2中所示结构的修复装置将要通过环形夹3、4植入主动脉瓣膜AV的主动脉口AO中。当如此植入时,修复装置的狭口部分2被植入主动脉口AO中,并且修复装置的扩散式锥形部分5容纳在主动脉AA中。
为了将修复装置PD输送到植入地点,它被引入包括气囊201和鞘管202的导管200中。处于充气状态中的气囊201容纳修复装置的狭口部分2和两个环形夹3、4。鞘管202包围整个修复装置并且将它,包括环形夹3、4和扩散式锥形部分5保持在用于通过动脉输送的压缩状态中。
将导管引入病人的外围动脉中并且以传统方式操纵以使狭口部分2与主动脉口AO对齐,同时两个环形夹3、4位于形成孔口的瓣叶的相对侧(图15a)。
鞘管202然后移动到一侧(图15b)释放第一环形夹3使其展开(图15c),然后释放并展开环形夹4(图15d、图15e),并且最终释放并展开修复装置的扩散式锥形部分5(图15f)。气囊201然后充气(图15g)以将基座部分2牢固压在孔口内,然后放气(图15h)以允许导管200与气囊201和鞘管202一起从动脉中取出,留下修复装置夹在孔口内。
因为修复装置由两个环形夹3、4夹紧孔口,因此可能并非必需使用气囊;但是,这可以用于更加确保修复装置正确植入孔口内。但是,提供两个环形夹3、4使得狭口部分2能够仅仅稍微扩张,即扩张至远低于传统支架式植入的程度,并由此减小阻塞或闭塞冠状动脉的危险。
图16a至图16f显示了通过如下状态放置图11中所示修复装置(即包括支撑元件40的环形阵列)的上述单鞘管法:图16a,其中狭口部分32位于主动脉口中;图16b,其中鞘管201已经移动到一侧足以释放夹子33的指状物33a;图16c,其中鞘管的继续移动释放另一个环形夹34的指状物34a;图16d和16e,其中鞘管的继续移动开始释放修复装置的扩散式锥形部分35;和图16f,其中鞘管已经移动至足以释放并用于展开整个修复装置,包括锥形部分35和环绕锥形部分的支撑元件40。如图16f中具体地显示,支撑元件40构成为在修复装置的植入状态中不会阻塞冠状动脉CA。
虽然图16a至图16f中所示的方法没有使用可充气的气囊,但是应该认识到,也可以使用这种可充气的气囊,如上面关于图15a至图15h所述,以更加确保修复装置牢固植入主动脉口中。
双鞘管放置法
图17a至图17h显示了放置修复装置的双鞘管法。出于示例的目的,上面所述修复装置为图4至图8中所示的修复装置。
因此,在双鞘管法中,其中由附图标记300表示的导管包括位于外端用于与修复装置的环形夹13接合的第一鞘管301和从鞘管301向内延伸以至于与修复装置的环形夹14和扩散式锥形部分15接合的第二鞘管302。这是图17a中所示的状态。
首先操纵导管使修复装置的狭口部分12位于主动脉口中(图17a)。鞘管302然后横向移动到一侧(向右)以便于释放环形夹14(图17b)。当夹子已经释放时,导管然后向心脏内移动(向左)微量距离(图17c)以将环形夹14的夹紧指状物14a牢固压在瓣叶的各个表面上,以至于环形夹14牢固接合图17c中所示瓣叶的主动脉表面(图8中附图标记18)。
外部鞘管301然后背对鞘管302,即向左移动进一步进入心脏。该动作释放环形夹13至其展开状态,与瓣叶面对左心室的表面(图8中附图标记19)接触(图17d)。此时,导管300于是可以沿相反方向(向右)移动以将环形夹13的夹紧指状物13a与瓣叶的该表面牢固接合。
主动脉内部的鞘管302于是可以进一步背对鞘管301移动,由此释放修复装置的其余部分,用于展开,如图17e和图17f中所示。
如果需要,图17a至图17f中所示的导管也可以包括气囊(未示出),以至于在主动脉口内稍微进一步扩张金属基座12,在这种情况下,然后可以将气囊放气以便于允许取出导管及其鞘管。
在上述放置方法中可以认识到,即使没有使用气囊,当取出各个鞘管时,各种修复装置的基座部分仍然将稍微扩张,以使基座部分牢固位于主动脉瓣环内并且还允许取出导管及其鞘管。但是,提供这种气囊允许另外扩张修复装置的基座部分至足以更加确保牢固植入孔口内,但是没有达到阻塞或闭塞冠状动脉的程度。
虽然已经关于几种优选实施例说明了本发明,但是应该认识到,这些仅仅是出于示例的目的而给出,并且可以对本发明进行很多其它的变化、修改和应用。
Claims (40)
1、一种修复装置,其用于病人心脏的主动脉瓣膜中治疗主动脉瓣狭窄,所述修复装置具有用于通过动脉输送的压缩状态并且可以展开至用于植入的展开状态,所述修复装置包括:
可展开的金属基座,其构成为可以以修复装置的展开状态植入主动脉瓣膜的主动脉瓣环中;和
内膜,其衬入金属基座的内表面;
其特征在于,修复装置的展开状态中的所述内膜伸入主动脉中并且为扩散式锥形结构,其中它的直径从其位于主动脉瓣环内的近端到其伸入主动脉中的远端逐渐增加,以至于在心脏收缩期间产生进入主动脉的非紊态血液流,同时伴有塑料内膜远端的压力恢复。
2、根据权利要求1所述的修复装置,其特征在于,在修复装置的展开状态中,扩散式锥形结构的所述内膜具有直径为5至20mm的近端和直径为15至30mm的远端,并且具有15至45mm的长度。
3、根据权利要求2所述的修复装置,其特征在于,内膜的所述近端包括位于所述主动脉瓣环内部的具有同一直径的短直部分,所述短直部分有效避免通过所述塑料内膜的流动分离。
4、根据权利要求3所述的修复装置,其特征在于,所述短直部分具有2至10mm的长度。
5、根据权利要求1所述的修复装置,其特征在于,病人心脏的所述主动脉瓣膜为下面类型,即包括可以移动至开放和关闭位置的多个瓣叶,并且其中所述金属基座包括两个环形夹,这两个环形夹可以与位于开放位置的所述瓣叶的相对侧接合用于将金属基座夹在所述瓣叶上。
6、根据权利要求5所述的修复装置,其特征在于,所述两个环形夹中每个都包括指状物的环形阵列。
7、根据权利要求6所述的修复装置,其特征在于,所述金属基座包括位于修复装置远端的支撑元件的环形阵列,其可以与主动脉的内表面接合用于在主动脉内部支撑修复装置。
8、根据权利要求7所述的修复装置,其特征在于,所述支撑元件在一端与所述环形夹之一的指状物的所述环形阵列一体形成。
9、根据权利要求1所述的修复装置,其特征在于,所述金属基座在修复装置的展开状态中延伸至内膜的所述远端,以至于所述内膜用作内衬,其从修复装置的所述近端至所述远端衬入金属基座的内表面。
10、根据权利要求9所述的修复装置,其特征在于,所述金属基座在修复装置的远端携带有修复瓣膜,该修复瓣膜控制从心脏进入主动脉的血液流。
11、根据权利要求10所述的修复装置,其特征在于,所述修复瓣膜包括可以移动至开放和关闭位置的多个瓣叶。
12、根据权利要求11所述的修复装置,其特征在于,修复瓣膜的所述瓣叶与衬入金属基座内表面的所述内膜为一体。
13、根据权利要求1所述的修复装置,其特征在于,所述金属基座其结构和尺寸形成为在植入时只接合主动脉瓣膜的主动脉瓣环,伸入主动脉的所述内膜在心脏收缩期间为所述扩散式锥形结构,以允许通过其中的向前血液流,但是在心脏舒张期间收缩以堵塞通过其中的反向血液流。
14、根据权利要求13所述的修复装置,其特征在于,伸入主动脉的所述内膜由柔韧性材料构成。
15、根据权利要求13所述的修复装置,其特征在于,伸入主动脉的所述内膜包括多个轴向延伸的加强支柱。
16、根据权利要求15所述的修复装置,其特征在于,所述加强支柱与所述金属基座铰链连接。
17、一种修复装置,其用于植入形成于人体通道壁中的孔口中,所述修复装置具有用于经由人体通道输送到植入地点的压缩状态,并且可以展开至用于植入所述孔口中的展开状态;所述修复装置包括:
可展开的金属基座,其构成为可以容纳在所述孔口中;和
两个环形夹,其由所述金属基座携带并且在金属基座的展开状态中可以与所述壁的相对面接合用于将所述金属基座夹在所述孔口内。
18、根据权利要求17所述的修复装置,其特征在于,所述两个环形夹中每个都包括指状物的环形阵列。
19、根据权利要求17所述的修复装置,其特征在于,所述修复装置还包括衬入所述金属基座内表面的内膜;所述内膜在修复装置的展开状态中为扩散式锥形结构,其特征在于,它的直径从其位于所述孔口内的近端到其与所述孔口间隔的远端逐渐增加。
20、根据权利要求19所述的修复装置,其特征在于,在修复装置的展开状态中,扩散式锥形结构的所述内膜具有直径为5至20mm的近端和直径为15至30mm的远端,并且具有15至45mm的长度。
21、根据权利要求20所述的修复装置,其特征在于,扩散式锥形结构的所述内膜还包括与所述近端具有相同直径并且位于其附近的短直部分。
22、根据权利要求21所述的修复装置,其特征在于,所述短直部分具有2至10mm的长度。
23、根据权利要求19所述的修复装置,其特征在于,所述金属基座在修复装置的展开状态中延伸至内膜的所述远端,以至于所述内膜用作内衬,其从修复装置的所述近端至所述远端衬入金属基座的内表面。
24、根据权利要求23所述的修复装置,其特征在于,所述孔口为病人心脏中主动脉瓣膜的主动脉瓣环;并且其中金属基座的所述远端携带有修复瓣膜,该修复瓣膜控制从心脏到主动脉的血液流。
25、根据权利要求24所述的修复装置,其特征在于,所述修复瓣膜包括可以在心脏收缩期间移动至开放位置和在心脏舒张期间移动至关闭位置的多个瓣叶。
26、根据权利要求25所述的修复装置,其特征在于,修复瓣膜的所述瓣叶与衬入金属基座内表面的所述内膜为一体。
27、根据权利要求24所述的修复装置,其特征在于,所述金属基座包括位于修复装置远端的支撑指状物的环形阵列,其可以与主动脉的内表面接合用于在主动脉内部支撑修复装置的远端。
28、根据权利要求24所述的修复装置,其特征在于,所述金属基座其结构和尺寸形成为在植入时只接合主动脉瓣膜的主动脉瓣环,伸入主动脉的所述内膜在心脏收缩期间为所述扩散式锥形结构,以允许通过其中的向前血液流,但是在心脏舒张期间收缩以堵塞通过其中的反向血液流。
29、根据权利要求28所述的修复装置,其特征在于,伸入主动脉的所述内膜由柔韧性材料构成。
30、根据权利要求29所述的修复装置,其特征在于,伸入主动脉的所述内膜包括多个轴向延伸的加强支柱。
31、根据权利要求30所述的修复装置,其特征在于,所述加强支柱与所述金属基座铰链连接。
32、根据权利要求31所述的修复装置,其特征在于,所述加强支柱由与所述金属基座相同的材料构成并且通过一体铰链枢轴连接于其上。
33、一种方法,其用于将根据权利要求17所述的修复装置植入形成于人体通道壁中的孔口中,包括:
将压缩状态中的所述修复装置引入导管中,其中导管具有可以接合并且压缩所述两个环形夹的鞘管;
将所述导管和修复装置经由所述人体通道输送到植入地点,使所述金属基座位于所述孔口中,并且所述两个环形夹位于形成有所述孔口的壁的相对侧;
将所述鞘管移动到一侧释放一个所述环形夹使其展开,然后释放并展开另一个所述环形夹;和
从所述人体通道中取出所述导管和所述鞘管,留下植入所述孔口中的金属基座,而所述环形夹接合所述壁的相对侧。
34、根据权利要求33所述的方法,其特征在于,所述修复装置在由所述鞘管保持在所述压缩状态中时被越过气囊引入所述导管中,所述气囊在取出所述鞘管之后充气以在所述孔口内扩张金属基座,所述气囊放气以从所述通道中取出导管和鞘管。
35、根据权利要求33所述的方法,其特征在于,所述孔口为病人心脏中主动脉瓣膜的主动脉瓣环。
36、根据权利要求35所述的方法,其特征在于,所述修复装置在其远端携带有修复瓣膜,该修复瓣膜控制从心脏进入主动脉的血液流。
37、一种方法,其用于将根据权利要求17所述的修复装置植入形成于人体通道壁中的孔口中,包括:
将压缩状态中的所述修复装置引入导管中,其中导管具有可以与一个所述环形夹接合用于将其保持在所述压缩状态中的第一鞘管和可以与另一个所述环形夹接合用于将其保持在所述压缩状态中的第二鞘管;
将所述导管和修复装置经由所述人体通道输送到植入地点,使金属基座位于所述孔口中,并且所述两个环形夹位于形成孔口的所述壁的相对侧;
将所述第一鞘管移动到一侧以将所述一个环形夹释放至其展开状态;
将所述第二鞘管移动到相对侧以将所述第二环形夹释放至其展开状态;和
从所述人体通道中取出所述导管和所述鞘管,留下植入所述孔口中的金属基座,而所述环形夹接合所述壁的相对侧。
38、根据权利要求37所述的方法,其特征在于,所述修复装置在由所述鞘管保持在所述压缩状态中时被越过气囊引入所述导管中,所述气囊在取出所述鞘管之后充气以将金属基座牢固压在所述孔口内,所述气囊放气以从所述通道中取出导管和鞘管。
39、根据权利要求37所述的方法,其特征在于,所述孔口为病人心脏的主动脉瓣膜的主动脉瓣环,并且包括可以移动至开放和关闭位置的瓣叶;并且其中首先展开的所述第一环形夹位于金属基座面对主动脉的一侧,并且所述第二环形夹位于金属基座面对心脏的一侧。
40、根据权利要求39所述的方法,其特征在于,所述修复装置在其远端携带有修复瓣膜,该修复瓣膜控制从心脏进入主动脉的血液流,所述修复瓣膜由所述第一鞘管压缩,通过在移动所述第二鞘管之前将第一鞘管移动到一侧而部分展开,并且通过在移动所述第二鞘管之后所述第一鞘管的进一步移动而完全展开。
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2004
- 2004-07-06 RU RU2006103367/14A patent/RU2006103367A/ru not_active Application Discontinuation
- 2004-07-06 CN CN2004800256667A patent/CN1849102B/zh not_active Expired - Fee Related
- 2004-07-06 US US10/563,384 patent/US7429269B2/en active Active
- 2004-07-06 CA CA2531528A patent/CA2531528C/en not_active Expired - Fee Related
- 2004-07-06 JP JP2006518487A patent/JP4942031B2/ja not_active Expired - Fee Related
- 2004-07-06 BR BRPI0412362-0A patent/BRPI0412362A/pt not_active Application Discontinuation
- 2004-07-06 AU AU2004253375A patent/AU2004253375B2/en not_active Ceased
- 2004-07-06 EP EP04744941.8A patent/EP1648339B2/en not_active Not-in-force
- 2004-07-06 WO PCT/IL2004/000601 patent/WO2005002466A2/en active Application Filing
- 2004-07-06 KR KR1020067000423A patent/KR20060112705A/ko not_active Application Discontinuation
-
2006
- 2006-02-06 NO NO20060588A patent/NO20060588L/no not_active Application Discontinuation
Cited By (13)
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CN101287424B (zh) * | 2004-12-30 | 2011-02-09 | 文托技术有限公司 | 流体流动修复装置 |
US11844345B2 (en) | 2005-06-28 | 2023-12-19 | Transmedics, Inc. | Systems, methods, compositions and solutions for perfusing an organ |
US11917991B2 (en) | 2007-03-20 | 2024-03-05 | Transmedics, Inc. | Systems for monitoring and applying electrical currents in an organ perfusion system |
US11856944B2 (en) | 2011-04-14 | 2024-01-02 | Transmedics, Inc. | Organ care solution for ex-vivo machine perfusion of donor lungs |
US11944088B2 (en) | 2014-06-02 | 2024-04-02 | Transmedics, Inc. | Ex vivo organ care system |
US11903381B2 (en) | 2014-06-02 | 2024-02-20 | Transmedics, Inc. | Ex vivo organ care system |
CN111134899A (zh) * | 2015-02-12 | 2020-05-12 | 赫莫迪纳克斯科技有限公司 | 主动脉植入物 |
CN111134899B (zh) * | 2015-02-12 | 2022-06-10 | 赫莫迪纳克斯科技有限公司 | 主动脉植入物 |
CN112933394B (zh) * | 2015-09-09 | 2023-10-24 | 特兰斯迈迪茨公司 | 用于在离体器官护理系统中使用的主动脉插管 |
CN112933394A (zh) * | 2015-09-09 | 2021-06-11 | 特兰斯迈迪茨公司 | 用于在离体器官护理系统中使用的主动脉插管 |
CN106377341B (zh) * | 2016-09-29 | 2018-02-16 | 复旦大学附属中山医院 | 一种血流分流器 |
CN106377341A (zh) * | 2016-09-29 | 2017-02-08 | 复旦大学附属中山医院 | 一种血流分流器 |
CN113164720A (zh) * | 2018-09-19 | 2021-07-23 | Nxt生物医疗有限责任公司 | 在生物结构的脉管和腔室之间建立连接和分流的方法和技术 |
Also Published As
Publication number | Publication date |
---|---|
WO2005002466A3 (en) | 2005-03-03 |
WO2005002466A2 (en) | 2005-01-13 |
EP1648339B1 (en) | 2013-02-20 |
CN1849102B (zh) | 2011-01-19 |
US20060259134A1 (en) | 2006-11-16 |
KR20060112705A (ko) | 2006-11-01 |
EP1648339A4 (en) | 2011-03-16 |
BRPI0412362A (pt) | 2006-09-05 |
EP1648339A2 (en) | 2006-04-26 |
EP1648339B2 (en) | 2020-06-17 |
CA2531528A1 (en) | 2005-01-13 |
AU2004253375B2 (en) | 2011-07-14 |
AU2004253375A2 (en) | 2005-01-13 |
AU2004253375A1 (en) | 2005-01-13 |
CA2531528C (en) | 2013-09-03 |
NO20060588L (no) | 2006-04-10 |
JP4942031B2 (ja) | 2012-05-30 |
JP2007526789A (ja) | 2007-09-20 |
US7429269B2 (en) | 2008-09-30 |
RU2006103367A (ru) | 2006-06-27 |
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