CN109890431B - 心室辅助装置 - Google Patents
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Abstract
描述了设备和方法,该方法包括将叶轮(50)放置在受试者的血管内,叶轮包括至少一个螺旋形长形元件(52)和弹簧(54),弹簧布置在螺旋形长形元件内并与其同轴。材料薄膜(56)支撑在螺旋形长形元件和弹簧之间。使用叶轮将血液泵送通过受试者的血管。还描述了其它应用。
Description
相关申请的交叉引用
本申请要求以下申请的优先权:
2016年10月25日提交的Tuval的题为“Ventricular assist device”的美国临时专利申请62/412,631;和
2017年8月10日提交的Tuval的题为“Ventricular assist device”的美国临时专利申请62/543,540。
这两个上面引用的申请均通过引用并入本文。
发明的实施方案的领域
本发明的一些应用总体上涉及医疗设备。具体地,本发明的一些应用涉及心室辅助装置及其使用方法。
背景
心室辅助装置用于辅助患有心脏衰竭的患者进行心脏血液循环。最常见的是,左心室辅助装置适用于有缺陷的心脏,以便辅助左心室功能。在某些情况下,使用右心室辅助装置,以便辅助右心室功能。
实施方案的概述
根据本发明的一些应用,叶轮包括螺旋形长形元件、布置在螺旋形长形元件的内侧并与螺旋形长形元件同轴的弹簧、以及支撑在螺旋形长形元件和弹簧之间的材料薄膜。对于一些应用,叶轮包括构造成辅助受试者心室正常工作的心室辅助装置的一部分,例如左心室辅助装置构造成辅助受试者的左心室正常工作。心室辅助装置通常包括长形管,该长形管构造成穿过受试者的主动脉瓣,使得该管的近侧端部布置在受试者的主动脉内,而该管的远侧端部布置在受试者的左心室内。长形管包括由自扩张形状记忆合金形成的框架以及布置在框架上的血液不可渗透的材料。心室辅助装置包括泵,该泵通常包括叶轮和围绕叶轮布置的笼架(cage)。叶轮通常构造成通过旋转将血液泵出受试者的左心室并泵入到受试者的主动脉。通常,叶轮还阻止血液穿过主动脉瓣从主动脉回流到左心室。
对于一些应用,笼架与长形管一体地形成,使得笼架在长形管的近侧端部处布置在长形管的框架内。因此,泵布置在长形管的近侧部分内,并且泵的纵向轴线由此与长形管的纵向轴线对齐。可选地,笼架未与长形管一体地形成。
因此,根据本发明的一些应用,提供了一种设备,该设备包括:
叶轮,该叶轮包括:
至少一个螺旋形长形元件;
弹簧,该弹簧布置在螺旋形长形元件内并与其同轴;和
材料薄膜,该材料薄膜支撑在螺旋形长形元件和弹簧之间。
在一些应用中,叶轮包括多个螺旋形长形元件,并且材料薄膜支撑在多个螺旋形长形元件和弹簧之间,使得叶轮界定多个叶片。
在一些应用中,当叶轮以非径向约束构型布置时,螺旋形长形元件的螺距沿螺旋形长形元件的长度变化。
在一些应用中,当叶轮以非径向约束构型布置时,螺旋形长形元件的螺距大于1mm。
在一些应用中,当叶轮以非径向约束构型布置时,螺旋形长形元件的螺距小于20mm。
在一些应用中,叶轮构造成放置在受试者的血管内,并通过叶轮旋转将血液泵送通过受试者的血管。
在一些应用中,叶轮构造成放置在受试者的主动脉中,并通过叶轮旋转从受试者的左心室泵送血液。
在一些应用中,叶轮构造成放置在受试者的心室中,并通过叶轮旋转从心室泵送血液。
在一些应用中,叶轮构造成放置在受试者的主动脉中,并阻止血液从主动脉回流到受试者的左心室中。
在一些应用中,叶轮构造成由螺旋形长形元件径向地约束,并且弹簧被轴向拉长,并且响应于螺旋形长形元件和弹簧的轴向拉长,薄膜构造成改变形状而无材料薄膜断裂。
在一些应用中,该设备还包括:
长形管,其构造成穿过受试者的主动脉瓣,使得该管的近侧端部布置在受试者的主动脉内,并且该管的远侧端部布置在受试者的左心室内,该长形管包括:
由形状记忆合金形成的框架;和
布置在框架上的血液不可渗透的材料;和
围绕叶轮布置的笼架,
长形管构造成围绕笼架和所叶轮布置,并且叶轮构造成通过旋转将血液从左心室泵送到主动脉。
在一些应用中,弹簧当以其非径向约束构型布置时构造成借助其刚性在叶轮旋转期间使叶轮相对于长形管稳定,使得叶轮的外边缘和长形管的内表面之间的间隙被保持。
在一些应用中:
弹簧界定穿过其中的内腔,并且
叶轮还包括:
近侧衬套和远侧衬套;和
刚性轴,其构造成经由由弹簧界定的内腔从近侧衬套延伸到远侧衬套,刚性轴构造成在叶轮旋转期间使叶轮相对于长形管稳定,使得叶轮的外边缘和长形管的内表面之间的间隙被保持。
在一些应用中,笼架与长形管的框架一体地形成,使得笼架在长形管的近侧端部处布置在长形管的框架内,叶轮因此布置在长形管的近侧部分内,并且叶轮的纵向轴线因此与长形管的纵向轴线对齐。
在一些应用中,叶轮的外边缘和长形管的内表面之间的间隙小于1mm。
在一些应用中,叶轮的外边缘和长形管的内表面之间的间隙小于0.4mm。
在一些应用中,叶轮构造成相对于长形管稳定,使得在叶轮旋转期间,叶轮和长形管之间的间隙被保持。
在一些应用中,笼架不与长形管的框架一体地形成。
在一些应用中,该设备还包括一个或更多个支撑臂,该一个或更多个支撑臂构造成从笼架延伸到长形管的框架,并且构造成在叶轮旋转期间使叶轮的远侧端部相对于长形管的框架稳定,使得叶轮的外边缘和长形管的内表面之间的间隙被保持。
在一些应用中,支撑臂构造成相对于长形管的框架可滑动。
在一些应用中,支撑臂构造成联接到长形管的框架。
在一些应用中,该设备还包括多个翼形突出部,多个翼形突出部联接到长形管使得由翼形突出部界定的平面平行于长形管的纵向轴线,翼形突出部构造成通过沿长形管的纵向轴线方向引导血流来稳定由叶轮的旋转产生的血液湍流。
在一些应用中,长形管构造成当处于径向约束构型时,经导管***受试者的身体内,并且翼形突出部构造成当长形管处于其径向约束构型时变成折叠的。
在一些应用中,弹簧界定穿过其中的内腔,并且叶轮还包括:
近侧衬套和远侧衬套;和
刚性轴,其构造成经由由弹簧界定的内腔从近侧衬套延伸到远侧衬套。
在一些应用中,刚性轴构造成保持近侧衬套和远侧衬套彼此对齐。
在一些应用中,叶轮构造成放置在受试者的身体内,并且在将弹簧放置在受试者的身体内之后,刚性轴构造成放置在由弹簧界定的内腔内。
在一些应用中,叶轮构造成放置在受试者的身体内,并且刚性轴构造成在叶轮放置在受试者的身体内期间布置在由弹簧界定的内腔内。
在一些应用中,叶轮还包括近侧衬套和远侧衬套,并且弹簧当以其非径向受约束构型布置时构造成借助其刚性保持近侧衬套和远侧衬套彼此对齐。
在一些应用中,当弹簧以其非径向约束构型布置时,弹簧构造成使得在弹簧的线圈和其相邻线圈之间大体上没有间隙。
根据本发明的一些应用,提供了一种方法,该方法包括:
将叶轮放置在受试者的血管内,叶轮包括:
至少一个螺旋形长形元件;
弹簧,该弹簧布置在螺旋形长形元件内并与其同轴;和
材料薄膜,该材料薄膜支撑在螺旋形长形元件和弹簧之间;
使用叶轮将血液泵送通过受试者的血管。
根据结合附图进行的本发明的实施方案的以下详细描述,本发明将会被更充分地理解,在附图中:
附图说明
图1A和图1B是根据本发明的一些应用的布置在受试者左心室中的心室辅助装置的示意图;
图2是根据本发明的一些应用的包括叶轮和笼架的泵的示意图;
图3是根据本发明的一些应用的心室辅助装置的长形管的框架和心室辅助装置的叶轮的笼架的示意图;
图4A和图4B是根据本发明的一些另外的应用的心室辅助装置的示意图;
图5A和图5B是根据本发明的一些应用的图4A和图4B中所示的心室辅助装置的叶轮的相应横截面图的示意图;
图5C是根据本发明的一些应用的图4A和图4B中所示的心室辅助装置的横截面图的示意图;
图5D是根据本发明的一些应用的处于径向约束构型的图4A和图4B中所示的心室辅助装置的叶轮的示意图;
图6A和图6B是根据本发明的一些应用的心室辅助装置的定子的示意图;以及
图7A、7B和图7C是根据本发明一些应用的包括离心泵的心室辅助装置的示意图。
具体实施方式
现在参考图1A和图1B,其是根据本发明的一些应用的布置在受试者左心室22中的心室辅助装置20的示意图。心室辅助装置包括长形管24,长形管24穿过受试者的主动脉瓣26,使得长形管的近侧端部28布置在受试者的主动脉30中,并且管的远侧端部32布置在左心室22中。长形管通常包括由诸如镍钛诺的自扩张形状记忆合金形成的径向可扩张框架34,以及布置在框架上的血液不可渗透的材料36。例如,血液不可渗透的材料可以包括聚氨酯、聚酯和/或硅树脂。通常,框架为长形管提供刚性,并且血液不可渗透的材料为长形管提供血液不可渗透性。此外,通常,框架的形状记忆合金成形为使得框架在没有任何力施加到管上的情况下呈现其管状形状。通常,当管处于径向约束状态时,装置20经由导管(例如,经由肱动脉)***到左心室中。当从导管中释放出来时,由于框架扩张,管自动地呈现其管状形状。泵40布置在长形管内(例如,如所示,在长形管的近侧部分内),并且构造成将血液通过长形管从左心室泵入主动脉,以辅助左心室正常工作。
图2是根据本发明的一些应用的泵40的示意图。泵40通常包括布置在径向可扩张的笼架44内的径向可扩张叶轮42。通常,泵40被经导管***到左心室中,同时叶轮和笼架处于径向约束构型中。叶轮和笼架通常包括形状记忆合金(例如镍钛诺),形状记忆合金成形为使得叶轮和笼架在没有任何径向约束力作用在叶轮和笼架上的情况下呈现非径向约束(即径向扩张)的构型。因此,通常,笼架和叶轮在从导管的远侧端部(笼架和叶轮经由该远侧端部被***)释放出来时径向扩张。对于一些应用,接合机构使叶轮和笼架相对于彼此接合,使得响应于笼架变得径向约束而叶轮也变得被径向约束,例如,根据Schwammenthal的WO 14/141284中描述的设备和方法,该WO 14/141284通过引用并入本文。一般地,泵40大致类似于Schwammenthal的WO 14/141284、Schwammenthal的WO 15/177793和/或Schwammenthal的WO 16/185473中描述的血液泵,所有以上三个文件通过引用并入本文。通常,泵40通过叶轮旋转将血液通过长形管从左心室泵入主动脉中。对于一些应用,旋转线缆46(图1B)使叶轮旋转。通常,旋转线缆通过布置在受试者体外或体内的马达(未示出)来旋转。
对于一些应用,泵40布置在长形管的近侧端部,使得泵布置在主动脉内。对于一些应用,泵布置在长形管的远侧端部,使得泵布置在受试者的心室内。
现在参考图3,图3是根据本发明的一些应用的心室辅助装置20的长形管24的框架34和泵40的笼架44的示意图。如所示,对于一些应用,笼架与长形管的框架一体地形成,使得笼架在长形管的近侧端部处布置在长形管的框架内。通常,由于笼架在长形管的近侧端部处布置在长形管的框架内,所以泵40布置在长形管的近侧部分内,并且泵的纵向轴线与长形管的纵向轴线对齐。对于一些应用,长形管24的框架34和笼架44由形状记忆材料(例如,形状记忆合金,例如镍钛诺)的单个件(例如,单个管)切割而成。通常,由于由形状记忆材料的单个件切割而成,管的其中布置笼架的区域能够径向地压缩成比如果笼架由形状记忆材料的分开的件切割而成时可能压缩成的直径小的直径并且能够被***在长形管内,或者反之亦然,其它因素不变的话。
现在参考图4A,图4A是根据本发明的一些应用的心室辅助装置20的示意图。对于一些应用,泵40大致如图4A中所示。通常,泵包括叶轮50,叶轮50包括外螺旋长形元件52,外螺旋形长形元件52缠绕在中心轴向弹簧54周围,使得由螺旋形长形元件界定的螺旋状件与中心轴向弹簧同轴。对于一些应用,螺旋形长形元件和中心轴向弹簧由形状记忆材料制成,例如形状记忆合金,例如镍钛诺。通常,螺旋形长形元件和中心轴向弹簧支撑在其之间的材料(例如,聚合物,例如聚氨酯和/或硅树脂)的薄膜56。螺旋形长形元件、轴向弹簧和薄膜界定了叶轮叶片,其中螺旋形长形元件界定叶轮叶片的外边缘(且从而界定叶轮的外边缘),并且轴向弹簧界定叶轮叶片的轴线。对于一些应用,缝合线(例如,聚酯缝合线,未示出)缠绕在螺旋形长形元件周围,例如,如WO 14/141284中所描述的,该WO 14/141284通过引用并入本文。通常,缝合线构造成有助于材料(通常是聚合物,例如聚氨酯或硅树脂)的薄膜和螺旋形长形元件(通常是形状记忆合金,例如镍钛诺)之间的结合。对于一些应用,缝合线(例如,聚酯缝合线,未示出)缠绕在弹簧54周围。通常,缝合线构造成有助于材料(通常是聚合物,例如聚氨酯或硅树脂)的薄膜和弹簧(通常是形状记忆合金,例如镍钛诺)之间的结合。
通常,弹簧54和螺旋形长形元件52的近侧端部均联接到叶轮的近侧衬套(即套筒轴承)64,使得弹簧54和螺旋形长形元件52的近侧端部均布置在彼此距叶轮的纵向轴线相似的径向距离处。类似地,通常,弹簧54和螺旋形长形元件52的远侧端部均联接到叶轮的远侧衬套58,使得弹簧54和螺旋形长形元件52的远侧端部均布置在彼此距叶轮的纵向轴线相似的径向距离处。
对于一些这样的应用,长形管24的框架34不包括与其一体形成的笼架,如上文参考图3所描述的。相反,对于一些这样的应用,通过从叶轮的远侧衬套径向向外延伸到长形管24的框架34的一个或更多个支撑臂60,叶轮的远侧衬套58相对于长形管被稳定。如图4A中所示,对于一些应用,支撑臂不联接到长形管的框架34,而是构造成接合长形管的内表面,从而使叶轮的远侧衬套相对于长形管稳定。对于这种应用,支撑臂通常构造成通过支撑臂沿长形管的内表面滑动而相对于长形管可移动。可选地,即使支撑臂未与长形管的框架34一体地形成,支撑臂也联接到长形管的框架34(例如,通过焊接、缝合和/或粘合剂),使得至少在支撑臂联接到长形管的框架的位置,支撑臂不可以相对于长形管运动。进一步可选地,该装置包括与长形管的框架34一体地形成的支撑臂,如图4B中所示。
现在参考图4B,图4B是根据本发明的一些应用的装置20的示意图,该装置包括支撑臂59,支撑臂59与长形管24的框架34一体地形成,支撑臂在联接点61处联接到框架34。通常,支撑臂构造成从叶轮的远侧衬套延伸到联接点,并且构造成由此使叶轮的远侧衬套相对于长形管稳定。
关于图4A-图4B中所示的装置20,应当注意,对于一些应用,如所示,叶轮50布置在长形管的近侧端部处,使得在装置20的使用期间,叶轮布置在主动脉内,并且通过在主动脉内旋转将血液从左心室泵入主动脉中。对于一些应用(未示出),叶轮布置在长形管的远侧端部处,使得在使用装置20期间,叶轮布置在心室内,并且通过在心室内旋转将血液泵出心室。一般地,在本申请的上下文中,术语“血管”应该被解释为包括心室。类似地,被描述为放置在血管内的叶轮应被解释为包括放置在心室内的叶轮。
现在参考图5A和图5B,图5A和图5B是根据本发明的一些应用的叶轮50的分别垂直于叶轮的纵向轴线和沿叶轮的纵向轴线的横截面图的示意图。还参考图5C,图5C是根据本发明的一些应用的心室辅助装置20的沿该装置的纵向轴线的横截面图的示意图。例如,如图5B中所示,弹簧54界定穿过其中的内腔62。对于一些应用,刚性轴63至少从叶轮的近侧衬套64到远侧衬套58沿内腔布置。刚性轴构造成将旋转运动从近侧衬套传递到远侧衬套,和/或保持远侧衬套和近侧衬套彼此对齐并与长形管的纵向轴线对齐。可选地或另外地,弹簧54本身充当轴。因此,对于一些应用,弹簧将旋转运动从近侧衬套传递到远侧衬套,和/或保持远侧衬套和近侧衬套彼此对齐并与长形管的纵向轴线对齐。对于一些这样的应用,弹簧构造成使得当弹簧以非径向约束构型布置时,在弹簧的线圈和与该线圈相邻的线圈之间大体上没有间隙。
现在参考图5D,该图5D是根据本发明的一些应用的处于径向约束(即轴向拉长)构型的叶轮50的示意图。通常,泵40经导管***左心室,而叶轮50处于其径向约束构型中。如所示,在径向约束构型中,螺旋形长形元件52和中心轴向弹簧54均变得轴向拉长,并且被径向约束。通常,材料(例如硅树脂)的薄膜56改变形状以符合螺旋形长形元件和轴向支撑弹簧的形状变化,螺旋形长形元件和轴向支撑弹簧两者均支撑材料的薄膜。通常,使用弹簧来支撑薄膜的内边缘允许薄膜改变形状,而薄膜不变得断裂或向内塌陷到布置在内腔62内的轴上,这是因为弹簧提供了结合薄膜内边缘的大的表面积。对于一些应用,相对于如果例如使用刚性轴支撑薄膜的内边缘,使用弹簧来支撑薄膜的内边缘减小了叶轮可以被径向约束至的直径,因为弹簧本身的直径可以通过轴向拉长弹簧来减小。如上面所描述的和如图5C中所示的,对于一些应用,刚性轴63沿内腔62(由弹簧54界定)至少从叶轮的近侧衬套64布置到远侧衬套58。对于某些应用,即使在叶轮经导管***受试者左心室期间,刚性轴也布置在内腔内。可选地,一旦叶轮已经从***导管释放出,则刚性轴行进到内腔62中,并与受试者的心室一起布置在内腔62中。
再次参考图5A,通常在叶轮的外边缘和长形管24的内表面之间存在间隙G,即使在叶轮的跨度处于其最大值的位置处也是如此。对于一些应用,期望的是叶轮叶片的外边缘和长形管24之间的间隙相对较小,以便叶轮有效地将血液从受试者的左心室泵入受试者的主动脉中。然而,还期望的是保持叶轮叶片的外边缘和长形管24之间的间隙,例如,以便降低溶血的风险。对于一些应用,在叶轮的跨度处于其最大值的位置处,叶轮的外边缘和长形管24的内表面之间的间隙G大于0.05mm(例如,大于0.1mm),和/或小于1mm(例如,小于0.4mm),例如,0.05mm-1mm,或0.1mm-0.4mm)。如上文所描述的,对于一些应用,叶轮的远侧衬套58通过一个或更多个支撑臂60或支撑臂59相对于长形管被稳定。对于一些应用,通过使叶轮的远侧衬套58相对于长形管稳定,即使叶轮叶片的外边缘和长形管24之间的相对小的间隙(例如,如上面所描述的间隙)也可在叶轮旋转期间被保持。可选地或另外地,经由由弹簧54界定的内腔62,刚性轴沿叶轮的轴线***,并且刚性轴使叶轮的远侧衬套58相对于长形管稳定,使得即使叶轮叶片的外边缘和长形管24之间相对较小的间隙(例如,如上面所描述的间隙)也可在叶轮旋转期间被保持。此外,可选地或另外地,弹簧54足够刚性,以使叶轮的远侧衬套58相对于长形管稳定,使得即使叶轮叶片的外边缘和长形管24之间相对较小的间隙(例如,如上面所描述的间隙)也可在叶轮旋转期间被保持。
通常,当叶轮50处于非径向约束构型时(例如,在受试者心室内),螺旋形长形元件52的螺距大于1mm(例如,大于6mm),和/或小于20mm(例如,小于10mm)。通常,其它因素不变,螺旋形长形元件(且因此叶轮叶片)的螺距越大,叶轮产生的血流就越大。因此,如所描述的,当叶轮50处于非径向约束构型时,螺旋形长形元件52的螺距通常大于1mm(例如,大于6mm)。另一方面,在心脏舒张期间,通常需要叶轮阻断从受试者主动脉到受试者左心室的回流。其它因素不变,通常的情况是螺旋形长形元件(以及因此叶轮叶片)的螺距越小,叶轮提供的阻塞越大。因此,如所描述的,当叶轮50处于非径向约束构型时,螺旋形长形元件52的螺距通常小于20mm(例如,小于10mm)。
对于一些应用,至少当叶轮处于非径向约束构型时,螺旋形长形元件(且因此叶轮叶片)的螺距沿螺旋形长形元件的长度变化。通常,对于这种应用,螺距从叶轮的远侧端部(即,***受试者的身体内更远并且相对于顺行血流方向放置在上游的端部)到叶轮的近侧端部(即,相对于顺行血流方向放置在下游的端部)逐渐增加,使得螺距在血流方向上增加。通常,血流速度沿叶轮、沿血流方向增加。因此,螺距沿血流方向增加,以便进一步加速血液。
对于一些应用(未示出),叶轮50大致如图4A-5D中所示,但是叶轮包括多个螺旋形长形元件。例如,叶轮可以包括两个或三个螺旋形长形元件。通常,材料的薄膜支撑在多个螺旋形长形元件和弹簧之间,使得叶轮界定多个叶片。通常,叶轮叶片的数量对应于布置在叶轮上的螺旋形长形元件的数量,例如,如Schwammenthal的WO 14/141284中大致描述的那样,该WO 14/141284通过引用并入本文。
现在参考图6A和图6B,图6A和图6B是根据本发明的一些应用的心室辅助装置20的定子65的示意图。为了说明的目的,图6B示出了没有心室辅助装置的一些其它元件的定子。对于一些应用,如所示,定子65布置在长形管24的框架34的近侧部分内。通常,定子包括多个(例如,多于2个和/或少于8个)翼形突出部66,当装置20处于非径向约束构型中时,该多个翼形突出部66从框架34延伸,并且由柔性材料(例如聚合物,例如聚氨酯和/或硅树脂)制成。翼形突出部通常构造成界定平行于长形管纵向轴线的平面,并因此构造成通过沿长形管纵向轴线的方向引导血流来稳定由叶轮产生的血液湍流。
注意,如图6A中所示,通常,长形管24包括布置在管框架34上的血液不可渗透的材料36。例如,如上文所描述的,血液不可渗透的材料可以包括聚氨酯、聚酯或硅树脂。注意,通常,长形管包括血液不可渗透的材料,即使如此,出于说明的目的,在本申请的所有附图中没有示出管的血液不可渗透的材料。
如图6B中所示,对于一些应用,缝合线68缠绕在框架34的部分上,以便有助于根据上文描述的技术在翼形突出部和框架34之间进行联接。对于一些应用,翼形突出部从框架34延伸到轴向支撑元件69。通常,轴向支撑元件是由金属、塑料和/或聚合物(例如聚氨酯和/或硅树脂)形成的管状元件。对于一些应用,定子65与长形管24的框架34一体地形成。可选地或另外地,定子与长形管分开形成。
如上文所描述的,通常,装置20经导管***受试者的心室,而长形管24处于径向约束状态。当从导管释放时,由于长形管24的框架34自扩张,管自动地呈现其管状形状。通常,定子在长形管内***受试者的左心室。在***期间,定子的翼形突出部处于折叠状态,并且相对于管不包含翼形突出部的情况,不显著增加长形管可被径向约束的最小直径。当长形管的框架34扩张时,由于翼形突出部联接到框架34,翼形突出部构造成自动地呈现它们的翼形构型。
注意,尽管图1A和图1B示出了受试者左心室中的心室辅助装置20,但是对于一些应用,装置20放置在受试者右心室内,使得该装置穿过受试者的肺动脉瓣,并且本文中描述的技术加以变更后被应用。可选地或另外地,装置20和/或其一部分(例如,叶轮50,即使在没有长形管24的情况下)放置在受试者身体的不同部分内,以便辅助从该部分泵送血液。例如,装置20和/或其一部分(例如,叶轮50,即使在没有长形管24的情况下)可以放置在血管中,并且可以用于将血液泵送通过血管。对于一些应用,加上必要的修改,装置20和/或其一部分(例如,叶轮50,即使在没有长形管24的情况下)构造成在静脉与淋巴导管的接合部处放置在锁骨下静脉或颈静脉内,并用于增加淋巴流体从***到静脉的流动。
现在参考图7A,图7A是根据本发明的一些应用的包括离心泵72的心室辅助装置70的示意图。还参考图7B和图7C,其分别示出了根据本发明的一些应用的离心泵的三维横截面图和二维横截面图。
对于一些应用,心室辅助装置通过使用离心泵将血液从受试者的左心室泵出受试者身体并泵入到受试者的主动脉30来辅助心室(例如左心室22)的泵送。对于一些应用,导管74***受试者的脉管***,该脉管***从离心泵72延伸到受试者的心室。如图7B和图7C中所示,通常,导管74界定同心的管76和管78。血液经由同心管中的第一管(例如,内管76,如图7C中指示血流方向的虚线箭头所示)泵出受试者的左心室,并且血液经由同心管中的第二管(例如,外管78,如图7C中所示)泵入受试者的主动脉。通常,第一管和第二管经由单个***点,例如股动脉80,如图7A中所示,或者经由不同的***点,例如锁骨下动脉,***到受试者身体内。对于一些应用,离心泵72界定附加的管82,经由该管测量血压。
本发明的范围包括将本文中所描述的任何设备和方法与以下一个或更多个申请中所描述的任何设备和方法相结合,所有以下申请均通过引用并入本文:
Tuval的2017年9月28日提交的标题为“Blood vessel tube”的国际专利申请PCT/IL2017/051092,Tuval的2016年9月29日提交的美国临时专利申请62/401,403;
Schwammenthal的2016年5月18日提交的标题为“Blood pump”的国际专利申请PCT/IL2016/050525(公开为WO 16/185473),该专利申请要求Schwammenthal的2015年5月18日提交的标题为“Blood pump”的美国临时专利申请62/162,881的优先权;
Schwammenthal的2015年5月19日提交的标题为“Blood pump”的国际专利申请PCT/IL2015/050532(公开为WO 15/177793),该专利申请要求Schwammenthal的2014年5月19日提交的标题为“Blood pump”的美国临时专利申请62/000,192的优先权;
Schwammenthal的2014年3月13日提交的标题为“Renal pump”的国际专利申请PCT/IL2014/050289(公开为WO 14/141284),该专利申请要求(a)Schwammenthal的2013年3月13日提交的标题为“Renal pump”的美国临时专利申请61/779,803,和(b)Schwammenthal的2013年12月11日提交的标题为“Renal pump”的美国临时专利申请61/914,475;
Tuval的2014年12月11日提交的标题为“Curved catheter”的美国专利申请14/567,439(公布为US 2015/0157777),该专利申请要求Tuval的2013年12月11日提交的标题为“Curved catheter”的美国临时专利申请61/914,470的优先权,和
Tuval的2013年6月6日提交的标题为“Prosthetic renal valve”的国际专利申请PCT/IL2013/050495(公布为WO 13/183060),该专利申请要求Tuval的2012年6月6日提交的标题为“Prosthetic renal valve”的美国临时专利申请61/656,244的优先权。
因此,根据本发明的一些应用,提供了以下发明构思:
发明构思1.一种设备,包括:
构造成辅助受试者左心室正常工作的左心辅助装置,该左心辅助装置包括:
长形管,其构造成穿过受试者的主动脉瓣,使得管的近侧端部布置在受试者的主动脉内,并且管的远侧端部布置在受试者的左心室内,该长形管包括:
由形状记忆合金形成的框架;和
布置在框架上的血液不可渗透的材料;
可旋转叶轮,其构造成通过旋转将血液从受试者的左心室泵送到受试者的主动脉;和
多个翼形突出部,其联接到长形管,使得由翼形突出部界定的平面平行于长形管的纵向轴线,翼形突出部构造成通过沿长形管的纵向轴线的方向引导血流来稳定由叶轮的旋转产生的血液湍流。
发明构思2.根据发明构思1的设备,其中,长形管构造成当处于径向约束构型中时经导管***受试者的身体内,并且其中翼形突出部构造成当长形管处于其径向约束构型时变成折叠的。
发明构思3.一种方法,包括:
将长形管放置在受试者的身体内,使得长形管穿过受试者的主动脉瓣,使得管的近侧端部布置在受试者的主动脉内,并且管的远侧端部布置在受试者的左心室内,该长形管包括:
由形状记忆合金形成的框架,和
布置在框架上的血液不可渗透的材料;和
通过使布置在长形管内的叶轮旋转将血液从受试者的左心室泵送到受试者的主动脉,
多个翼形突出部联接到长形管,使得由翼形突出部界定的平面平行于长形管的纵向轴线,翼形突出部构造成通过沿长形管的纵向轴线的方向引导血流来稳定由叶轮旋转产生的血液湍流。
发明构思4.根据权发明构思3的方法,其中将长形管放置到受试者的身体内包括当长形管处于径向约束构型时,将长形管经导管放置在受试者的身体内,翼形突出部构造成当长形管处于其径向约束构型时变成折叠的。
发明构思5.一种设备,包括:
构造成辅助受试者左心室正常工作的左心辅助装置,该左心辅助装置包括:
长形管,其构造成穿过受试者的主动脉瓣,使得管的近侧端部布置在受试者的主动脉内,并且管的远侧端部布置在受试者的左心室内,该长形管包括:
由形状记忆合金形成的框架;和
布置在框架上的血液不可渗透的材料;和
泵,其包括可旋转叶轮和布置在可旋转叶轮周围的笼架,
该笼架与长形管一体地形成,使得笼架在长形管的近侧端部处布置在长形管的框架内,从而泵布置在长形管的近侧部分内,并且泵的纵向轴线由此与长形管的纵向轴线对齐。
发明构思6.一种方法,包括:
将构造成辅助受试者左心室正常工作的左心室辅助装置放置在受试者的身体内,该左心室辅助装置包括:
长形管,其构造成穿过受试者的主动脉瓣,使得管的近侧端部布置在受试者的主动脉内,并且管的远侧端部布置在受试者的左心室内,该长形管包括:
由形状记忆合金形成的框架,和
布置在框架上的血液不可渗透的材料,以及
泵,其包括可旋转叶轮和布置在可旋转叶轮周围的笼架,
该笼架与长形管一体地形成,使得笼架在长形管的近侧端部处布置在长形管的框架内,从而泵布置在长形管的近侧部分内,并且泵的纵向轴线由此与长形管的纵向轴线对齐;以及
通过旋转叶轮将血液从受试者的左心室泵送到受试者的主动脉。
发明构思7.一种用于将血液从受试者的身体内的第一位置泵送到受试者的身体内的第二位置的血液泵,该血液泵包括:
第一管,其用于泵送血液离开第一位置;
第二管,其用于将血液泵送到第二位置,第一管和第二管相对于彼此同轴;和
离心泵,其构造成泵送血液通过第一管和第二管。
发明构思8.一种方法,包括:
通过以下方式将血液从受试者的身体内的第一位置泵送到受试者的身体内的第二位置:
经由第一管泵送血液离开第一位置;
经由第二管将血液泵送到第二位置,第一管和第二管相对于彼此同轴;和
使用离心泵将血液泵送通过第一管和第二管。
本领域技术人员应认识到本发明不限于上文中已特别示出和描述的内容。而是,本发明的保护范围包括上文中描述的各种特征的组合与子组合以及在阅读前面描述时本领域技术人员可想到的不在现有技术中的本发明的变化和修改。
Claims (22)
1.一种用于泵送血液的设备,所述设备包括:
血液泵,所述血液泵包括:
叶轮,所述叶轮包括:
近侧衬套和远侧衬套;
至少一个螺旋形长形元件;
轴向弹簧,所述弹簧布置在所述螺旋形长形元件的内侧,并界定穿过其中的内腔;和
材料薄膜,其支撑在所述螺旋形长形元件和所述弹簧之间,使得所述材料薄膜从所述螺旋形长形元件延伸到所述弹簧,从而界定叶轮叶片;和
刚性轴,其构造成经由由所述弹簧界定的所述内腔从所述近侧衬套延伸到所述远侧衬套;
其中,所述叶轮构造成由所述螺旋形长形元件径向地约束,并且所述弹簧被轴向地拉长,并且其中响应于所述螺旋形长形元件和所述弹簧的轴向拉长,所述薄膜构造成改变形状而无所述材料薄膜断裂。
2.根据权利要求1所述的设备,其中,所述叶轮包括多个螺旋形长形元件,并且所述材料薄膜支撑在所述多个螺旋形长形元件和所述弹簧之间,使得所述叶轮界定多个叶片。
3.根据权利要求1所述的设备,其中,当所述叶轮以非径向约束构型布置时,所述螺旋形长形元件的螺距沿所述螺旋形长形元件的长度变化。
4.根据权利要求1所述的设备,其中,当所述叶轮以非径向约束构型布置时,所述螺旋形长形元件的螺距大于1mm。
5.根据权利要求1所述的设备,其中,当所述叶轮以非径向约束构型布置时,所述螺旋形长形元件的螺距小于20mm。
6.根据权利要求1所述的设备,其中,所述叶轮构造成放置在受试者的血管内,并且通过所述叶轮旋转将血液泵送通过受试者的血管。
7.根据权利要求1所述的设备,其中,所述叶轮构造成放置在受试者的主动脉中,并且通过所述叶轮旋转从受试者的左心室泵送血液。
8.根据权利要求1所述的设备,其中,所述叶轮构造成放置在受试者的心室中,并且通过所述叶轮旋转从心室泵送血液。
9.根据权利要求1所述的设备,其中,所述叶轮构造成放置在受试者的主动脉中,并且阻止血液从主动脉回流到受试者的左心室中。
10.根据权利要求1-9中任一项所述的设备,还包括:
长形管,其构造成穿过受试者的主动脉瓣,使得所述管的近侧端部布置在受试者的主动脉内,并且所述管的远侧端部布置在受试者的左心室内,所述长形管包括:
由形状记忆合金形成的框架;和
布置在所述框架上的血液不可渗透的材料;并且
所述长形管构造成围绕所述叶轮布置,并且所述叶轮构造成通过旋转将血液从左心室泵送到主动脉。
11.根据权利要求10所述的设备,其中,所述弹簧当以其非径向约束构型布置时构造成借助其刚性使所述叶轮在所述叶轮旋转期间相对于所述长形管稳定,使得所述叶轮的外边缘和所述长形管的内表面之间的间隙被保持。
12.根据权利要求10所述的设备,其中所述刚性轴构造成在所述叶轮旋转期间使所述叶轮相对于所述长形管稳定,使得所述叶轮的外边缘和所述长形管的内表面之间的间隙被保持。
13.根据权利要求10所述的设备,其中,所述叶轮的外边缘和所述长形管的内表面之间的间隙小于1mm。
14.根据权利要求13所述的设备,其中,所述叶轮的所述外边缘和所述长形管的所述内表面之间的所述间隙小于0.4mm。
15.根据权利要求13所述的设备,其中,所述叶轮构造成相对于所述长形管稳定,使得在所述叶轮旋转期间,所述叶轮和所述长形管之间的所述间隙被保持。
16.根据权利要求10所述的设备,还包括多个翼形突出部,所述翼形突出部联接到所述长形管,所述翼形突出部构造成通过沿所述长形管的纵向轴线的方向引导血流来稳定由所述叶轮的旋转产生的血液湍流。
17.根据权利要求16所述的设备,其中,所述长形管构造成当处于径向约束构型时,经导管***受试者的身体内,并且其中所述翼形突出部构造成当所述长形管处于其径向约束构型时变成折叠的。
18.根据权利要求1-9中任一项所述的设备,其中,所述刚性轴构造成保持所述近侧衬套和所述远侧衬套彼此对齐。
19.根据权利要求1-9中任一项所述的设备,其中,所述叶轮构造成放置在受试者的身体内,并且其中在将所述弹簧放置在受试者的身体内之后,所述刚性轴构造成放置在由所述弹簧界定的所述内腔内。
20.根据权利要求1-9中任一项所述的设备,其中,所述叶轮构造成放置在受试者的身体内,并且其中所述刚性轴构造成在所述叶轮放置在受试者的身体内期间,布置在由所述弹簧界定的所述内腔内。
21.根据权利要求1-9中任一项所述的设备,其中所述弹簧当以其非径向约束构型布置时构造成借助其刚性保持所述近侧衬套和所述远侧衬套彼此对齐。
22.根据权利要求21所述的设备,其中,所述弹簧当以其非径向约束构型布置时构造成使得在所述弹簧的线圈和其相邻线圈之间大体上没有间隙。
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CA3039285A1 (en) | 2018-05-03 |
WO2018078615A1 (en) | 2018-05-03 |
JP2024023258A (ja) | 2024-02-21 |
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