CN103800952A - 用于跨瓣膜导管的支撑支架 - Google Patents
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Abstract
本发明提供了一种用于跨瓣膜导管的支撑支架,其适于把穿过支撑环的基本上为筒形的部件保持在中心位置,所述支撑环具有附连到环形支架的两片或三片心脏瓣膜小叶,所述支撑环包括:圆形或椭圆形环,在所述圆形或椭圆形环上附连有两个或三个瓣膜小叶支撑部件,所述支撑部件在穿过瓣膜的血流方向上离开支撑环的平面轴向地突出;以及一个或多个导管支撑支柱,所述导管支撑支柱也附连到所述环上,并且在与穿过瓣膜的血流方向相反的方向上轴向地突出。
Description
技术领域
本发明涉及用于跨瓣膜导管的支撑支架。
背景技术
小型微创血泵对增大晚期心力衰竭病人的血流量是有用的。关于这些装置所做的早期工作包括:美国专利4,846,152号的血泵,美国专利5,376,114、5,755,784、5,776,190、5,888,241号的插管泵,以及美国专利申请20090203957号的HeartWare“长角”泵。植入数小时或数天的临时轴流血泵诸如Impella泵(美国专利5,921,913号的无定子血管内微型轴流泵,美国专利6,139,487号的心内泵装置,以及其他装置)正在被广泛地应用。Impella泵目前已通过FDA批准使用长达6小时。这些装置都利用小直径管(导管),血液通过该小直径管跨过心脏瓣膜,最常见的是主动脉瓣膜。在心脏收缩期间,瓣膜可以打开,同时由天然心脏喷射出的一部分血流量穿过小叶之间的口,并且另一部分血流量穿过血泵导管。这些装置的导管的位置很可能被推向瓣膜的一侧,并且不能被控制为保持在瓣膜口内的中心。如果把导管嵌在与天然瓣膜环接触的位置,那么将会形成裂缝,在该裂缝中可以形成血栓。如果之后导管移动,那么血栓将会崩散从而成为危险的血栓栓塞。
我们之前已授权的美国专利7,479,102号的瓣膜泵是针对长期植入的,这种情况下装置可以植入并保持功能很多年。在所公开的瓣膜泵中,把非常小的泵放在主动脉瓣膜或肺动脉瓣膜的其中一片小叶的位置上,使三片瓣膜小叶中的两片小叶保持功能。本发明提供了使导管或血泵保持在瓣膜口的中心位置的手段,使得导管或血泵能够被最佳地冲洗从而防止血栓产生。
发明内容
1.本发明的目的是提供一种装置,从而使血流导管安全地保持在小叶心脏瓣膜口内的中心位置。
2.本发明的另一目的是使跨瓣膜血流导管稳定处于小叶型人工心脏瓣膜内的中心位置,使得在不损坏瓣膜或不产生血栓的情况下,小叶能够打开并关闭数百万循环。
3.本发明的另一目的是提高微型血管内心脏辅助系统的性能。
4.本发明的另一目的是提供改良的供长期使用的跨瓣膜血泵固定装置。
5.本发明的又一目的是提供用于跨瓣膜导管的固定装置,其通过消除在导管与瓣膜的一侧之间形成的裂缝,来使形成血栓的风险最小化。
6.另外,本发明的目的是提供一种装置,从而使小叶瓣膜和瓣膜自身内的跨瓣膜导管保持通畅而不形成血栓,对抗凝血剂(antigoagulation)的需求最少或者无需使用抗凝血剂。
7.本发明的另一目的是提供带瓣膜的跨瓣膜导管保持装置,其与微型跨瓣膜血泵紧密配合、并且关于该血泵的跨越瓣膜的导管部分使该血泵保持在最佳位置。
8.本发明的另一目的是提供带瓣膜的跨瓣膜导管保持装置,其包含的组织瓣叶可以湿储在无菌条件下,并且在外科手术中与干燥无菌导管或血泵一起使用。
附图说明
图1是来自现有技术的美国专利5,376,114号的附图,其示出位于左心室内的血泵和穿过主动脉瓣膜的血流导管。
图2是来自现有技术的美国专利7,022,100号的附图,其示出部分地位于左心室内、且部分地位于主动脉内的血泵,并且具有跨越主动脉瓣膜的血流导管。
图3是来自美国专利申请20090203957号的现有技术附图,其示出位于左心室内的血泵,具有穿过主动脉瓣膜的血流导管,并且具有位于左心室心尖的固定装置。
图4是来自美国专利申请20120029265号的现有技术附图,其示出位于主动脉内的血泵,具有穿过主动脉瓣膜的血流导管,并且具有位于主动脉内的固定装置。
图5是来自现有技术的专利申请20120029265号的附图,其示出包括可扩展的网状支架和铰接的支撑臂的固定装置。
图6是主动脉和主动脉瓣膜叶的视图,其示出处于把一片瓣膜小叶推向一侧的非中心位置的跨瓣膜导管。
图7示出本发明的实施例,其包括瓣膜支架和处于主动脉环内的导管支撑环,其中在主动脉环内通过把缝合套囊缝合到主动脉上而使导管支撑环固定。
图8是位于三片主动脉瓣膜叶内的中心位置的跨瓣膜导管的附图,其示出紧靠导管闭合的小叶。
图9示出本发明的实施例,其具有被三个支柱保持在中心位置并且在支撑环内支撑血流导管的支撑环。三片瓣膜小叶被显示为处于打开位置。
图10是通过螺纹固定到安装于支撑环中心位置上的瓣膜支架的跨瓣膜导管的纵剖面。
图11示出通过本发明的实施例被保持于主动脉环中心的跨瓣膜血流导管。心室内血泵接收左心室内的血液流入,并且泵送血液经由导管穿过主动脉瓣膜的中心,之后将血液排出到主动脉中。
图12示出本发明的实施例,其包括适于把跨瓣膜血泵安装到支撑环上的螺纹支撑环。
具体实施方式
可以用外科手术(诸如通过在左心室心尖上切口)植入的微型血泵已经得到了发展,并且可以在心导管实验室中经由外围血管(诸如股动脉)植入的另一些微型血泵已经得到了发展。许多这些微型血泵利用穿过主动脉瓣膜的导管,通过该装置泵送的血液必须穿过所述导管。参考图1,血泵2使血液流入左心室4内,并且使用导管6以便引导血液穿过主动脉瓣膜8进入主动脉10内。图2示出部分地位于左心室内、且部分地位于主动脉中的血泵12,其包括导管,血液通过所述导管流过主动脉瓣膜14并进入主动脉16内。
图3示出血泵18,其利用流出导管20来传输血液穿过主动脉瓣膜22进入主动脉24内。在图4中,血泵26位于主动脉28中,并且使用流入导管30,该流入导管30穿过主动脉瓣膜32并且具有位于左心室内的入口34。图5是可扩展网状固定装置36的放大视图,使用处于与主动脉瓣膜分开的位置的支柱38、40使血泵保持在主动脉的中心。该固定装置的功能是为了使泵保持在适当位置,使得即使由于血液喷射到主动脉中的反作用力,泵和流入导管也不会移位。
借助使用穿过主动脉瓣膜的导管的小型血泵,如果导管被保持在瓣膜的中心,则小叶会密封导管且不会产生回流。如果导管的直径较小(这会将血流量限制到相对低的值),则导管可以位于小叶之间并且几乎没有回流地进行密封。但是如果导管足够大从而能提供高于2-3L/min的流量,除非导管被保持在瓣膜的中心,否则它会将瓣膜小叶推至紧靠主动脉的一侧并会阻止瓣膜有效地闭合。
参考图6,血流导管42压缩一片瓣膜小叶44紧靠主动脉壁46。这会阻止三片小叶相互密封,并会产生开口48,在该开口48中会发生回流血流。本发明提供了支撑结构,其把导管保持在瓣膜小叶内的中心,所述瓣膜小叶如图8所示密封导管,从而避免回流血流。
参考图7,支撑支架50被显示为处于由缝合套囊54保持的主动脉环52内。为了清楚起见,在该附图中,把三个瓣膜小叶支撑杆56、58、60显示为未附连有瓣膜小叶。这三个杆通过一体环62相互连接在一起。应注意,所述杆在限定为从左心室心尖到主动脉的方向上突出。所述杆实际上突出到主动脉中。附连于环62上的是三个支撑支柱64、66、68,其附连于位于中心的导管支撑环70。小叶支撑杆、导管支撑环支柱以及导管支撑环全都优选地从聚合物固体杆加工而成(所述聚合物诸如缩醛均聚物(homopolymer acetal)),或者可以被模制为一体。应注意,瓣膜小叶支撑杆位于主动脉10中,并且导管支撑环支柱和导管支撑环处于靠近主动脉瓣膜环52的左心室的流出道内。
利用不同设计的支架来支撑小叶的各种类型的组织瓣膜在现有技术中是已知的。可以使用猪的瓣膜小叶,心包组织已被用来做成小叶形状,并且聚合物小叶也已经得到发展。本发明提供了与导管支撑结构相结合的小叶支撑支架,其中导管支撑结构可以是环70,或者仅是三个支柱64、66、68的末端而不使用环。如果支柱的末端被用来使导管保持在中心位置,则该导管的直径必须紧密贴合在支柱内,使得导管能很好地被保持。该装置还包括缝合套囊54,该缝合套囊54被用于利用广泛用于主动脉瓣膜置换的外科手术技术来把瓣膜和导管支撑件缝合到主动脉中。参考图11,可以清楚地看出,血流导管74把由血泵76产生的血流从左心室(箭头)通过瓣膜支撑环70的中心传导到导管78末端的主动脉中。
从图9可以最清楚地看出,在瓣膜小叶打开的情况下,导管74通过由支柱64、66、68支撑的环70,被保持在小叶80、82、84之间的瓣膜中心位置。所述支柱继而由支架支撑环50保持,支架支撑环50通过缝合环72而被缝合到主动脉中。
图10示出一个实施例,在该实施例中导管包括缩小的直径86,在该位置导管穿过瓣膜小叶的中心位置。在该附图中,一片小叶被显示为处于打开状态,并且用单个箭头92指示出穿过的血流,并且另一片小叶被显示为处于闭合位置,并且用两个箭头94指示出主动脉内的血压,该血压紧靠导管的缩小部分闭合小叶95。在实际状况下,三片小叶几乎同时打开和闭合,所以该附图表示的是两个位置(打开与闭合),但是并不表示瓣膜在某一时间点的构造。如果导管包括意图使小叶闭合发生于的缩小部分,则需要某种手段来使导管保持在正确的轴向位置。在图10所示的实施例中,导管96由内螺纹环90保持,所述内螺纹环90通过支柱88附连到瓣膜支架上。导管包括将该导管固定到螺纹环上的外螺纹98。这会把导管锁定在正确的轴向位置,使得缩小腔86与瓣膜小叶适当地沿轴向对准。
跨瓣膜导管支撑支架可以配置成借助螺纹连接114或其他直接附连机构来直接安装血泵。参考图12,血泵100包括安装在转子上的叶轮102,该转子具有小直径的细长轴104,其穿过与血泵一体形成的跨瓣膜导管106的缩小部分的中心。流入侧和流出侧转子轴承108、110把泵转子支撑在电动机(未示出)内,电动机经由电缆112给泵转子供电。把泵连接到支架的支撑环的螺纹114的位置被设置成使得瓣膜小叶紧靠血泵导管的缩小部分闭合,如116所示。应注意,该附图与图10相似,示出一片小叶打开、一片小叶闭合,从而示出两种情况下的位置。
利用本发明的该实施例,首先按照与主动脉组织瓣膜植入基本上相同的方式把跨瓣膜支撑支架缝合到主动脉环中。接着,把作为独立装置的血泵拧紧到螺纹支撑环上。这是在把电力电缆穿过主动脉壁(如图12所示)之前完成的。在附连血泵之后,使电力电缆穿过主动脉壁中的孔,并将其固定在适当位置。在该位置,电缆防止血泵处于未扭紧状态,因为电缆使泵旋转地锁定在适当位置。
本发明的说明书中公开的信息旨在仅代表我们所描述的原理。因此应认识到的是,上面阐述的本发明的目的以及根据前面的说明能够明显得出的目的可以有效地获得,并且可以对上面的产品和构造做出某些变更而不脱离本发明的保护范围。上面的说明中包含的以及附图中示出的所有内容应被解释为是例证性的,而非限制性的。还应理解的是,后附的权利要求旨在覆盖这里描述的本发明的所有一般和特定特征以及本发明的保护范围的所有陈述,这些陈述在语言上可以被认为是落入一般和特定特征之间。
Claims (8)
1.一种圆环形或椭圆环形支撑环,在所述支撑环上附连有缝合套囊,通过所述缝合套囊能够将所述支撑环缝合到心脏瓣膜的环中,所述支撑环具有一个或多个向内突出的支柱,所述支柱被配置成把穿过所述支撑环定位的细长跨瓣膜导管保持在所述支撑环内的中心位置。
2.如权利要求1所述的支撑环,包括附连到所述支柱的螺纹支撑件,其中支撑带有相应螺纹的跨瓣膜导管的螺纹部件能够附连到所述螺纹支撑件中。
3.一种带瓣膜导管支撑环,适于把穿过所述支撑环的基本上为管状的部件保持在中心位置,所述导管支撑环具有附连到环形支架的两片或三片心脏瓣膜小叶,所述导管支撑环包括:圆形或椭圆形环,在所述圆形或椭圆形环上附连有两个或三个瓣膜小叶支撑部件,所述支撑部件在穿过瓣膜的血流方向上离开所述支撑环的平面轴向地突出;以及一个或多个导管支撑支柱,所述导管支撑支柱也附连到所述环上,并且在与穿过所述瓣膜的血流方向相反的方向上轴向地突出。
4.如权利要求3所述的带瓣膜支撑环,包括在轴向位置附连到所述支柱的螺纹支撑件,所述螺纹支撑件通过与所述跨瓣膜导管互连的螺纹部件,使附连到所述小叶支撑部件的瓣膜小叶能够在最佳的预定轴向位置紧靠渐缩的跨瓣膜导管的表面进行密封。
5.如权利要求3所述的带瓣膜支撑环,其中所述跨瓣膜导管是横跨心脏瓣膜的血泵的一部分。
6.如权利要求3所述的带瓣膜支撑环,其中所述跨瓣膜导管被连接到布置在主动脉或肺动脉中的血泵。
7.如权利要求3所述的带瓣膜支撑环,其中所述跨瓣膜导管被连接到布置在左心室或右心室中的血泵。
8.一种心室内或动脉内的血泵,或者部分地布置在左心室或右心室中、且部分地布置在主动脉或肺动脉中的血泵,其具有细长导管,所述细长导管配置成通过在心脏瓣膜的环内缝合使所述导管保持在中心位置的结构部件,而被保持在所述心脏瓣膜内的中心位置。
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EP2727612B1 (en) | 2016-10-19 |
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