CN108601875B - 血泵*** - Google Patents
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Abstract
在包括血泵(50)和血管内流动插管(53)的血泵***中,压力传感器(30)布置在流动插管内,并且相对于流动插管的纵向轴线(1)布置在血流通过开口(54)的基准层处或布置成邻接血流通过开口(54)。通过这种布置,压力传感器(30)可以用于非常准确地安全地检测流动插管(53)外部的压力以及血管壁是否被吸入抵靠血流通过开口(54)的事实。
Description
背景技术
本发明涉及一种血泵***,其包括血泵和血管内流动插管,血管内流动插管与血泵流体连通并将血液从血管朝向血泵引导。
更具体地,血泵是血管内旋转血泵,其可以放置在血管内,例如左心室或右心室或主动脉或任何其他血管,视情况而定。血泵由电机驱动,电机可以在患者体外,或者可以与泵一起放置在血管内。在前一种情况下,泵经由柔性驱动线连接到外部电机,而在后一种情况下,泵和电机组合以形成一体的泵送装置,并优选地通过导管从患者体外接收能量。后一种结构是用于本发明的血泵***的优选结构,但是本发明不限于此。
例如,当这样的血泵***用于临时心脏维持时,它们被经皮引入例如股动脉并被引导通过身体的血管***,以便维持或替换心脏中的泵送动作。在运行期间,流动插管突出穿过心脏瓣膜开口,以使血能够经由泵被泵送穿过心脏瓣膜。此外,血泵***在血泵的壳体外部和流动插管的外部装备有压力传感器,以便建立入口压力和出口压力。关于入口压力和出口压力的数据以及血泵***的电机的功率消耗共同形成了一组用于血泵***的功能和输送速率的相关信息。另外,所测量的压力使得能够得出关于血泵在血管***中的定位的推论。此外,差力压与电机的当前功率消耗的比较使得能够确定局部状态以及汽蚀和吸入。
WO2013/160407A1提出为血泵***提供两个或两个以上的压力传感器。例如,压力传感器可以在血泵的近端处和/或在流动插管的远端处设置在血泵***的外部。附加的压力传感器可以设置在流动插管内,用于确定流动插管何时被吸入抵靠心室壁。在WO2013/160407A1中强调,除了流动插管内的压力传感器之外,同样重要的是具有在流动插管的外部、位于其血流通过开口附近以便测量那里的生理血压的压力传感器,以及特别是解决了外部压力传感器在流动插管上的优先布置,以测量患者心室中的生理压力。
发明内容
本发明的目的是相对于压力传感器的布置进一步改进已知的血泵***。
因此,本发明的血泵***包括血泵和与血泵流体连通的血管内流动插管,并且具有压力传感器,该压力传感器在流动插管的远端部分处在流动插管内布置在血流通过开口的区域中或布置成邻接血流通过开口的区域。流动插管的远端部分是更加远离血泵——即更加位于血泵远侧——的端部,并且位于流动插管的远端的血流通过开口用于使血液在其通往泵的途中进入流动插管,或在泵以相反方向被驱动时使血液离开流动插管。
重要的是,压力传感器布置在流动插管内。以这种方式,当流动插管被吸入抵靠心室壁或者流动插管以其他方式移位时,压力传感器不会被心室壁覆盖或以任何其他方式被阻挡。因此,例如,压力传感器指示出压力大约为零或者心跳的有节奏的压力差快速减小是流动插管被吸入抵靠心室壁的明显信号。换句话说,布置在流动插管内部的压力传感器尤其可以用作壁吸入指示器。
然而,由于其在流动插管的血流通过开口的区域中或邻接血流通过开口的区域的特定布置,所以相同的压力传感器可以用于第二目的,即测量或至少大致测量流动插管外部的压力,例如心脏的左心室或右心室内的压力,视情况而定,这是因为血流通过开口的区域中的血压基本上与流动插管外部的血压一致。因此,所提出的压力传感器的特殊位置使得其可以作出上述操作,而无需在流动插管的外部设置单独的外部压力传感器。尤其,根据本发明的优选实施方式,血泵***可以适于根据由布置在流动插管的远端部分内的压力传感器提供的第一压力值和由布置在血泵外部(例如在血泵壳体上)的第二压力传感器提供的第二压力值来确定压力差。
附图说明
在下文中,将参考附图以示例的方式解释本发明。其中示出了:
图1是血泵***,该血泵***具有血泵和流动插管,该流动插管被放置成穿过主动脉并延伸穿过主动脉瓣进入左心室(16),
图2A至2D,其为将压力传感器放置在流动插管内的各种选择,和
图3a 和3b ,其为限定了流动插管的流入保持架的框架结构的两种变型。
具体实施方式
图1示出了具有导管10的血泵***,在该示例中,导管10被引入到逆行的降主动脉11中。降主动脉11是主动脉12的一部分,主动脉12首先从心脏上升然后下降并具有主动脉弓14。主动脉瓣15位于主动脉12的起始处,主动脉瓣15将左心室16连接到主动脉12,并且血管内血泵***延伸到主动脉瓣15。除了导管10之外,血泵***还包括旋转泵50以及流动插管53,旋转泵50固定在导管软管20的远端并且具有电机部分51和泵部分52,泵部分52设置在距离电机部分51一轴向距离处,流动插管53 从泵部分52的流入端部沿远端方向突出。流动插管53在其远端部分EP 处具有血流通过开口54,其形成吸入入口,或者如果泵50以反向方向被驱动,则其形成血流出口。在通过开口54的远侧设置有软质柔性尖端55,其可以例如构造为“猪尾线(pigtail)”或J形。穿过导管软管20延伸出对于操作泵送装置50很重要的不同的线和装置。其中,图1仅示出了两个光纤 28A、28B,其在近端附接到评估装置(evaluation device)100。这些光纤 28A、28B分别是光学压力传感器的一部分,该光学压力传感器的传感器头 30和60一方面位于泵部分52的壳体外部上,另一方面位于流动插管53 的远端部分EP的内部。由传感器头30和60传输的压力在评估装置100 中被转换成电信号并显示在例如显示屏101上。
如上所述,本发明不限于具有一体的电机部分51的旋转泵。相反,用于驱动泵的电机可以设置在患者体外,并且柔性驱动线可以将泵与外部电机连接。
除了实际压力信号之外,借助于传感器头60测量主动脉压力和借助于传感器头30测量心室压力使得以下成为可能:例如,测量心脏恢复所借助的收缩性测量,以及用于计算泵送装置50的流量的压力差的建立。 WO2013/160407A1中更详细地解释了电光压力测量的原理以及光纤的结构和布置,其相应的公开内容通过引用并入本文。本发明与该公开的不同之处仅在于压力传感器30放置在流动插管53内的特定位置处,而不是放置在流动插管的外表面上,如下文将解释的那样。
图2A更详细地示出了根据优选实施方式的流动插管53的远端部分 EP。相对于其大致纵向轴线1,端部EP包括径向的血流通过开口54,其用于使血液进入,或根据情况使血液离开流动插管53。在血流通过开口54 的区域中,设置了包括多个支柱58的框架结构,以便形成用于两个目的的保持架。首先,支柱58将流动插管53的流动引导部分与软质柔性尖端55 连接。其次,形成保持架的框架结构防止心室壁被吸入并阻塞流动插管53。因此,支柱58通常可以轴向延伸,但是它们同样可以螺旋地延伸、彼此交叉和/或具有互相连接。如图2B所示,支柱58将血流通过开口54分为单独的血流开口54A至54D。血流通过开口54A和54D的区域中的虚线标记了流动插管53在血流入口54的区域A中的外部界限。
图2C是端部EP的截面图。由虚线围成的区域A指示了血流通过开口 54或各个开口54A至54D相对于流动插管的纵向轴线1的基准层。这是压力传感器30在流动插管内部可以被定位的区域。例如,如图2C所示,压力传感器可以放置在位置X处,并且通过仅示意性地示出的压力传感器30’例示。在任何情况下,压力传感器30’的压敏表面32应垂直于纵向轴线1取向,原因在WO2013/160407A1中有更详细的解释,即提高测量精度以便能够从信号数据导出高达250Hz的高频生理信号。
代替将压力传感器30放置在血流通过开口54的区域A中的某处,其可以邻接基准区域A。优选地,它被定位在其近端边界处,如图2C中通过压力传感器30”和30”’例示的。同样地,位于位置Y和位置Z处的压力传感器30”和30”’仅为示意性地示出,并且它们的压敏表面32同样垂直于纵向轴线1取向。即,血流通过开口54具有围绕通过开口54的边界线,或至少一个血流通过开口54A至54D中的每一个分别具有分别围绕通过开口 54A至54D的边界线,并且所述边界线具有近端部分,在图2所示的实施方式中,所述近端部分由形成流动插管53的一部分的漏斗结构56的端面 57形成。漏斗结构可以由薄膜形成,特别是由薄的聚合物膜形成。优选的是将压力传感器30精确地布置在围绕通过开口54或者通过开口54A至54D的边界线的近端部分57的基准层处,优选地使压力传感器的压敏表面设置在上述位置处,如图2C中的压力传感器30”和30”’示出的。因此,在泵正常运行期间,可以感测心室腔内的总体压力,同时对泵流量具有很小的干扰,乃至没有干扰。此外,如果存在吸入,那么处于该优选位置的传感器也能够检测到由于吸入而引起的负压,这是入口处的局部现象。更优选地,压力传感器被布置在框架结构上并且优选地固定到框架结构,例如固定到支柱58。该位置可以与支柱58相切,如图2C中的压力传感器30”所示,或者更优选地,该位置可以位于框架结构的径向内侧,如图2C中的压力传感器30”’所示。
图2D示出了压力传感器30可以在流动插管53内如何放置的具体示例,其对应于图2C中的压力传感器30”’的位置Z。因此,压力传感器30 的压敏表面32恰好在围绕通过开口54的边界线的近端部分57处邻接血流通过开口54的基准层,该近端部分57由围绕端部EP的框架结构的漏斗结构56的端面限定。如可见,光纤28A或多根光纤被保护在单独的管腔27内,光纤28A在管腔27内可自由移动。管腔27可以由聚合物,特别是聚氨酯,或优选地由镍钛诺或其他形状记忆合金组成,并且沿着柔性流动插管53在外部放置。管腔27通过漏斗结构56进入流动插管53,并且将具有压力传感器30的光纤28A的远端固定在支柱58的径向内侧。
虽然已经相对于与流动插管53的其余部分相比具有扩大的截面的端部EP描述了本发明,但是本发明不限于这方面。然而,扩大的截面,特别是从远端到近端呈漏斗形的漏斗形结构56是有利的,因为与流动插管53 的非漏斗形的其余部分内部的压降相比,沿着流动插管的轴线1的血流中的压降在漏斗形状中下降得没有那么迅速。因此,与非漏斗形的结构相比,将压力传感器30精确地放置在围绕通过开口的边界线的近端部分57处在漏斗形的流动插管中就没有那么关键,并且将压力传感器30误放在流动插管53的不那么远的轴向内侧也仅具有较小的影响。至少框架结构的支柱58 由例如镍钛诺的形状记忆合金或形状记忆聚合物制成,并且围绕框架结构的漏斗结构56由柔性材料制成,使得在将流动插管53***穿过患者的血管***时,框架结构连同漏斗结构56具有与流动插管53的其余部分基本相同的直径。在装置放置之后当框架结构达到体温时,将呈现具有扩大截面的扩展形态。
图3a和3b示出了限定流入保持架的可扩展框架结构的可替换形式。在图3a中,互相连接的支柱58设置在主支柱之间,提供了将入口/出口开口54A-D进一步分成更小的开口54A’-A”’的结构。因此,可以避免吸入高度柔性的结构,如瓣膜的器官(二尖瓣:小叶、腱索(cordae)、乳突结构)。这里,在图3a 中标记为ZZ的优选的传感器位置,将在互相连接的支柱58’和漏斗结构56的端面57的连接点处位于互相连接的支柱组件58’的径向内侧,例如,薄聚合物膜的边缘。
在图3b中,存在相同的互相连接的支柱组件58’,并且此外其例如通过镜像(58”)同样设置在柔性漏斗结构56的一侧。因此,可以避免漏斗结构56的局部向内弯曲,而这在正常流动状态期间由于当流动进入入口时的局部压降,或者在发生吸入期间可能存在真正负压时,原本是有可能发生的。通过局部地增加漏斗结构的厚度,可以进一步在结构上改进漏斗结构56的流入端面57。为了在发生吸入之后从心脏结构释放,径向更硬的漏斗结构56是特别有利的。
Claims (6)
1.一种血泵***,其包括血泵(50)和血管内流动插管(53),所述血管内流动插管(53)与所述血泵流体连通并且具有大致纵向轴线(1)、位于所述血泵远端的远端部分(EP)和更靠近所述血泵的近端部分,其中所述流动插管(53)在其远端部分(EP)处具有用于使血液进入或离开所述流动插管的至少一个血流通过开口(54;54A-54D),并且其中压力传感器(30;30’;30”;30”’)径向地布置在所述流动插管内,其中所述至少一个血流通过开口(54;54A-54D)中的每一个具有围绕所述通过开口的边界线,并且所述边界线具有近端部分(57),其特征在于,所述压力传感器(30;30’;30”;30”’)邻接所述边界线的所述近端部分(57)。
2.根据权利要求1所述的血泵***,其中在所述血流通过开口(54;54A-54D)的区域中设置有框架结构(58)并且所述压力传感器(30;30’;30”;30”’)布置在所述框架结构(58)上。
3.根据权利要求2所述的血泵***,其中所述压力传感器(30)相对于所述流动插管的纵向轴线(1)布置在所述框架结构(58)的径向内侧上。
4.根据权利要求1至3中任一项所述的血泵***,其中所述流动插管(53)具有在其远端部分(EP)处的扩大截面部分,并且所述至少一个血流通过开口(54;54A-54D)布置在所述扩大截面部分中。
5.根据权利要求4所述的血泵***,其中所述扩大截面部分包括从远端到近端呈漏斗形的漏斗结构(56),其中所述压力传感器(30)布置在所述漏斗结构的远端处。
6.根据权利要求1至3中任一项所述的血泵***,其包括压力传感器(60),所述压力传感器(60)布置在所述血泵(50)的外部,其中所述血泵***适于根据第一压力值和第二压力值确定压力差,所述第一压力值由布置在所述流动插管(53)内的所述压力传感器(30;30’;30”;30”’)提供,所述第二压力值由布置在所述血泵(50)外部的所述压力传感器(60)提供。
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