CN110944689B - 血管内流体运动设备、系统和使用方法 - Google Patents
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Abstract
一种血管内流体运动设备,包括:具有收缩的传送构型和扩展的部署构型的可扩展构件,所述可扩展构件具有近侧端部和远侧端部;在径向上和轴向上设置在所述可扩展构件内的可旋转构件;和联接到所述可扩展构件的管道,所述管道至少部分地限定了在所述管道的远侧端部与所述管道的近侧端部之间的血流管腔,所述管道在所述可扩展构件的远侧部分仅在径向上设置在所述可扩展构件内部。
Description
相关申请的交叉引用
本申请要求以下美国临时专利申请的优先权,这些临时专利申请通过引用并入本文:2017年6月7日提交的第62/516,296号申请和2017 年8月8日提交的第62/542,488号申请。
通过引用并入
本说明书中提到的所有出版物和专利申请通过引用并入本文,就像每个单独的出版物或专利申请都被明确地单独指出通过引用并入一样。
背景技术
心脏病患者驱动血液流经心脏和脉管系统的能力可能严重受损,比如,在例如球囊血管成形术和支架置入等矫正手术中存在巨大风险。有必要寻找改善这些患者的心脏流出的量或稳定性的方法,特别是在矫正手术中。
主动脉内球囊泵(IABP)通常用于支持血液循环功能,如治疗心力衰竭患者。IABP常用于心力衰竭患者的治疗,如在高危经皮冠状动脉介入治疗(HRPCI)、稳定患者心源性休克后的血流、治疗与急性心肌梗死(AMI) 相关的患者或治疗失代偿性心力衰竭中支持患者。这种血液循环支持可以单独使用或与药物治疗一起使用。
IABP通常是通过放置在主动脉内并随着心脏的收缩以反搏的方式膨胀和缩小来工作,从而为血液循环系统提供额外的支持。
最近,微创旋转血泵已经开发出来,其可以与心血管系统相关联地插入身体,例如从左心室向主动脉泵入动脉血液,以向患者心脏的左侧增加原生泵血能力。另一种已知的方法是将静脉血从右心室泵入肺动脉,以向患者心脏的右侧增加原生泵血能力。总的目标是减少患者心肌的工作量以稳定患者,例如在可能会给心脏带来额外的压力的医疗手术过程中,以在心脏移植前稳定患者,或为患者提供持续的支持。
目前可用的最小的旋转血泵可以通过通路护套经皮插入患者的脉管系统,因此不需要手术介入,或通过血管通路移植插入患者的脉管系统。对这种类型的设备的描述是经皮插入的心室辅助设备(“pVAD”)。
有必要对pVAD和类似的血泵领域提供额外的改进,以治疗受损的心脏血流。当前的pVAD设计成增加或替换心脏输出量,对于插入患者的血管来说可能不受欢迎地大(例如,需要大的股动脉通路护套或切口,其增大术后并发症率),提供不充足的血液流动或对血细胞产生大量的溶血破坏,从而导致不良的结果,在某些情况下导致死亡。
需要改进pVAD或类似设备,以最小化插入轮廓,从而最大限度地减少与血管通路相关的手术并发症,以使该设备产生的或辅助的血液流动最大化,最小化血液溶血和血栓形成,并利于医生和其职员在使用该产品期间需要管理的手术步骤。
一方面,需要较小的传送轮廓设备,该设备可以通过可选地小于12 FR、例如8FR或9FR的通路护套插入,也可以例如以大约60毫米汞柱的压头泵送在3.5L/min至6.0L/min的范围内、例如4.0L/min至5.0 L/min的血流量。众所周知,由于较高的旋转泵叶轮转速会增加溶血的风险,因此一方面需要一种泵,其可以在转速明显低于一些pVAD泵所采用的50,000rpm转速的情况下提供足够的流量。这些需求和现有方法的其他问题通过本文的公开得到了解决。
发明内容
本公开涉及一种医疗设备,该设备在使用时适用于使液体、例如血液运动。
本公开的一个方面是血管内血泵,其包括:具有收缩的传送构型和扩展的部署构型的可扩展构件,该可扩展构件具有近侧端部和远侧端部;在径向上和轴向上设置在可扩展构件内的叶轮;和联接至可扩展构件的管道,该管道至少部分地限定了在管道的远侧端部与管道的近侧端部之间的血流管腔,并且其中,在可扩展构件的远侧部分中,管道仅在径向上设置在可扩展构件之内。
可扩展构件的近侧部分和远侧部分各自的最外部尺寸大于可扩展构件的在轴向上设置在近侧部分和远侧部分之间的中心区域的最外部尺寸。
该管道的远侧端部可以具有向外扩口的构型。该管道的近侧端部可以没有扩口构型。
血泵还可以包括与叶轮操作地联通的驱动线缆。
血泵还可以包括:多个远侧定心支柱,其联接到可扩展构件并在叶轮的远侧围绕驱动线缆延伸;以及多个近侧定心支柱,其联接到可扩展构件并在叶轮的近侧围绕所述驱动线缆延伸。
在某些情况下,管道可能是非渗透的、半渗透的、甚至是多孔的。
可扩展构件可以包括多个细长元件,这些细长元件限定多个孔。
管道可以从管道的近侧端部到管道的远侧端部在径向上设置在可扩展构件内。
在管道仅在径向上设置在可扩展构件之内的位置,借助管道与可扩展构件之间的间隙,管道可以与可扩展构件在径向上间隔开。
管道还可以在可扩展构件的近侧区域内在径向上设置在可扩展构件之外。
本发明的一个方面是具有带部署构型的工作部分的血管内流体泵。工作部分包括:远侧可扩展构件,其具有收缩的传送构型、以及部署构型,该远侧可扩展构件具有近侧端部和远侧端部;在径向上设置在远侧可扩展构件内的远侧叶轮;近侧可扩展构件,其具有收缩的传送构型、以及部署构型,近侧可扩展构件具有近侧端部和远侧端部,其远侧端部与远侧可扩展构件的近侧端部轴向隔开;近侧叶轮,其在径向上设置在近侧可扩展构件内,近侧叶轮朝向近侧与远侧叶轮隔开;管道,其在远侧可扩展构件的近侧端部与近侧可扩展构件的远侧端部之间轴向延伸,管道至少部分地限定了在管道的远侧端部和管道的近侧端部之间的血流管腔,其中,管道的中心区域跨越轴向距离,且远侧可扩展构件和近侧可扩展构件不轴向延伸进中心区域,其中,远侧可扩展构件的远侧端部比管道的远侧端部进一步向远侧延伸,并且近侧可扩展构件的近侧端部比管道的近侧端部进一步向近侧延伸;和从工作部分向近侧延伸的细长部分。
管道可以联接到远侧可扩展构件和近侧可扩展构件。
工作部分还可以包括联接到可扩展构件的中心管状元件,其中中心管状元件设置在管腔中,并设置在近侧可扩展构件和远侧可扩展构件之间。近侧可扩展构件的远侧端部可以联接到中心管状元件的近侧端部,并且远侧可扩展构件的近侧端部可以联接到中心管状元件的远侧端部,中心管状元件可以在近侧可扩展构件和远侧可扩展构件之间延伸。中心管状元件可以在收缩构型和部署构型中都具有相同的最外部尺寸。
近侧叶轮和远侧叶轮可以可选地由共用驱动机构驱动,例如可以联接到近侧叶轮和远侧叶轮的共用驱动线缆。共用驱动机构可以限定内腔,它可以可选地用作导丝内腔。
共用驱动线缆可以包括联接到第二部分的第一部分,所述第一部分与所述第二部分相邻,第一部分和第二部分具有共同的纵向轴线和相对于该共同的轴线正交测量的共同的外部尺寸,其中第一部分比第二部分硬,并且远侧叶轮或近侧叶轮联接到第一部分。第一部分包括第一管状构件,第二部分包括卷绕构件。驱动线缆还可以包括与第二部分相邻的第三部分,第三部分与远侧叶轮和近侧叶轮中的另一者联接。
近侧叶轮和远侧叶轮可以与共同的电机操作地联通。
近侧可扩展构件可以联接至远侧轴承和近侧轴承,其中驱动机构延伸通过远侧轴承和近侧轴承。
近侧可扩展构件可以连接到所述远侧轴承和所述近侧轴承,其中所述驱动机构通过所述远侧轴承和所述近侧轴承延伸。
远侧可扩展构件可以包括相对于彼此设置以限定多个孔的多个细长段,其中多个孔之一的至少一部分在管道的远侧端部的远侧,从而限定允许血液进入管腔的至少一个血液入口孔。近侧可扩展构件可以包括相对于彼此设置以限定多个第二孔的多个细长段,其中多个第二孔之一的至少一部分位于管道的近侧端部的近侧,从而限定允许血液从管腔排出的至少一个出口孔。
远侧可扩展构件和近侧可扩展构件中的至少一个具有多个编织的细长段。
管道可选地是不渗透的、半渗透的和可选地多孔的。
管道可以由这样的材料制成,使得在远侧可扩展构件和近侧可扩展构件之间的轴向中心区域中,该材料适于响应于作用在工作部分上的径向向内的力而比可扩展构件更容易地径向向内变形。
管道可以在沿着近侧可扩展构件的相对于近侧可扩展构件的纵向轴线正交地测量的最大径向尺寸的位置处联接至近侧可扩展构件,并且,管道可以在沿着远侧可扩展构件的相对于远侧可扩展构件的纵向轴线正交地测量的最大径向尺寸的位置处联接至远侧可扩展构件。
管道在其联接至近侧可扩展构件的位置处可以在径向上设置在近侧可扩展构件内,并且,管道在其联接至远侧可扩展构件的位置处可以在径向上设置在远侧可扩展构件内。管道在其联接至近侧可扩展构件的位置处也可以在径向上设置在近侧可扩展构件之外,并且管道在其联接至远侧可扩展构件的位置处也可以在径向上设置在远侧可扩展构件之外。近侧可扩展构件可以具有在径向上向内和向远侧逐渐变细的远侧部分,并且远侧可扩展构件可以具有在径向上向内和向近侧逐渐变细的近侧部分,并且其中,管道在远侧部分中的第一位置处仅在径向上设置在近侧可扩展构件之外,并且不在第一位置处直接联接至近侧可扩展构件,并且其中,管道在近侧部分中的第二位置处仅在径向上设置在远侧可扩展构件之外,并且不在第二位置处直接联接至远侧可扩展构件。
在扩展构型中,远侧叶轮的远侧端部可以不比管道的远侧端部向远侧延伸更远。
在扩展构型中,近侧叶轮的近侧端部可以不比管道的近侧端部向近侧延伸更远。
管道可以是柔性的,并且可以可选地是顺应的。
在部署构型中,近侧叶轮可以比管道的近侧端部进一步向近侧延伸。
在部署构型中,远侧叶轮可以比管道的远侧端部进一步向远侧延伸。
管道的第一部分可以仅在径向上设置在近侧可扩展构件之外,并且,管道的在管道的第一部分近侧的第二部分可以在径向上设置在近侧可扩展构件之内。管道的第一部分可以位于近侧叶轮的远侧端部的远侧。
管道的第一部分可以仅在径向上设置在远侧可扩展构件之外,并且其中,管道的位于管道的第一部分的远侧的第二部分可以在径向上设置在远侧可扩展构件之内。管道的第一部分可以位于远侧叶轮的近侧端部的近侧。
本公开的一个方面与跨过瓣膜(例如主动脉瓣)部署血管内血泵的方法有关。
附图说明
图1A、图1B、图1C、图1D和图1E仅示出了本文的医疗设备的工作部分的示例性外部轮廓。
图2A是示例性工作部分的侧视图,该部分包括可扩展构件、叶轮和管道。
图2B是图2A的视图的一部分的近视图。
图3A是示例性工作部分的侧视图,其中管道的一部分仅在径向上位于可扩展构件内。
图3B是包含叶轮的示例工作部分的侧视图。
图4A和图4B示出了图3B中的设备的示例性布置。
图5是示例性工作部分的侧视图。
图6A、图6B和图6C示出了示例性工作部分的至少一部分。
图7A-图7E示出了示例性工作部分的至少一部分。
图8A-图8F示出了示例性工作部分的至少一部分。
图9示出了具有工作部分的示例性医疗设备的至少一部分。
图10示出了具有工作部分的示例性医疗设备的至少一部分。
图11示出了具有工作部分的示例性医疗设备的至少一部分。
图12示出了具有工作部分的示例性医疗设备的至少一部分。
图13A示出了具有工作部分的示例性医疗设备的至少一部分,其中至少两个不同的叶轮可以以不同的速度旋转。
图13B示出了具有工作部分的示例性医疗设备的至少一部分,其中至少两个不同的叶轮可以以不同的速度旋转。
图13C所示为示例性医疗设备的至少一部分,其工作部分具有至少两个具有不同节距的叶轮。
图14示出了具有工作部分的示例性医疗设备的至少一部分。
图15A-图15D是显示正在使用的示例性工作部分的示例性外部轮廓的端视图。
图16是包括管道、多个叶轮和可扩展构件的示例性工作部分的侧视图。
图17是包括管道、多个叶轮和多个可扩展构件的示例性工作部分的侧视图。
图18A、图18B、图18C和图18D示出了包括管道、多个叶轮和多个可扩展构件的示例性工作部分。
图19示出了工作部分的示例性布置,该工作部分包括管道、多个可扩展构件和多个叶轮。
图20A、图20B和图20C示出了工作部分的示例性远侧端部结构和构型。
图21A示出了部署的工作部分的示例性位置。
图21B和图21C示出了工作部分的示例性远侧区域。
图22A和图22B示出了示例性叶轮的端视图,其叶片处于收缩构型 (图22A)和扩展构型(图22B)。
图23A-图23C示出了示例性叶轮。
图24A和图24B示出了示例性叶轮。
图25A和图25B示出了处于收缩的传送构型(图25A)和扩展构型(图 25B)的示例性的多管腔工作部分。
图26A和图26B示出了分别显示了部署构型和扩展构型的工作部分的示例性多管腔设计。
图27A-图27C示出了具有至少一个额外管腔的工作部分的示例性实施例。
图28示出了示例性工作部分。
图29示出了包括工作部分的示例性流体运动医疗设备。
图30示出了用于电机和驱动线缆的示例性磁耦合。
图31示出了90度齿轮组的实施例。
图32A示出了包括管腔区域和呈大体直形构型的远侧末端的示例性工作部分。
图32B示出了穿过工作部分并进入远侧末端的内部细长构件,例如导丝。之前直形的末端持久地呈现出不同的构型。
图33A、图33B、图33C、图33D和图33E示出了示例性工作部分的示例性远侧端部。
图34示出了示例性工作部分。
图35示出叶轮的示例性实施例。
图36示出了带有显示器的示例性泵控制台。
具体实施方式
本发明涉及医疗设备、系统以及使用和制造方法。本文中所述的医疗设备可包括适于设置在生理血管内的远侧工作部分,其中远侧工作部分包括作用于流体的一个或多个部件。例如,本文中的远侧工作部分可以包括一个或多个旋转构件,所述旋转构件在被旋转时可以促进流体(如血液)的运动。
本文中的与系统、设备或使用方法的方面有关的任何公开均可与本文中的任何其他适当的公开合并在一起。例如,仅描述设备或方法的一个方面的图可以包含其它实施例,即使在本公开的一个或两个部分的描述中没有明确说明。因此,应当理解,除非另有明确说明,本文包括本公开的不同部分的组合。
图1A-图1E为用于医疗设备的工作部分(后面会有更详细的描述)的示例性外部轮廓(即外部构型),这些工作部分横跨瓣膜(例如主动脉瓣)延伸或与瓣膜交叉。所示仅为细长的近侧部分的一部分,其从工作部分向近侧延伸。示出了主动脉瓣、升主动脉和左心室的相对位置。图1A示出了示例性实施例,其中医疗设备包括具有大体圆柱形(即,不是真正的圆柱体而是近似圆柱体,使得本领域的普通技术人员应该理解其会被认为是圆柱形)的扩展构型的工作部分100,其中心区域跨越具有最大外形尺寸的瓣膜(相对于纵向轴线LA正交测量的,为简单起见仅在图1A中显示),并且其中,该外形尺寸在近侧方向和远侧方向变小。工作部分的大小设置成:当近侧端部位于升主动脉中时,远侧端部位于左心室。
当工作部分在瓣膜的位置扩展时,工作部分可能接触瓣膜小叶(不管瓣膜小叶是原生小叶或替代心脏瓣膜的一部分),并当在心脏泵送过程中将小叶压靠在工作部分上时,工作部分可能会对小叶造成损坏,并促进有效的瓣膜密封件紧靠工作部分闭合。因此,在工作部分与瓣膜(如大动脉)交叉或工作部分跨越瓣膜的位置,最小化或减小工作部分的轮廓可能是有利的,从而将对瓣膜小叶的损伤减到最小。图1B-图1E示出了示例性工作部分的构型,该工作部分具有减小的轮廓尺寸的中心区域,并且可以放置在瓣膜的位置,以减少瓣膜损坏的可能性。
图1B示出了示例性工作部分,其具有如图所示的大体圆柱形的扩展构型,并且其大小设置成,当近侧区域位于升主动脉中时,远侧区域位于心室中。工作部分的中心区域跨过瓣膜。扩展的外形构型是大体圆柱形的。
图1C示出了处于扩展构型的示例性工作部分,其中工作部分的远侧区域扩展到比工作部分的近侧区域更大的外形尺寸。外形尺寸在瓣膜的位置并向近侧延伸变得明显更小(例如,至少一半)。
图1D示出了处于扩展构型的示例性工作部分,其中工作部分的近侧区域(设置在升主动脉中)扩展到比工作部分的远侧区域更大的外形尺寸。外形尺寸在瓣膜的位置并向远侧延伸变得明显更小(例如,至少一半)。
图1E示出了处于扩展构型的示例性工作部分,其中近侧区域和远侧区域被配置为扩展到比中心区域更大的尺寸,其中中心区域设置在近侧区域和远侧区域之间。中心区域的外形尺寸可以是近侧区域和远侧区域中的一者或两者的一半或一半以下。图1E中的工作部分可以被认为在扩展时具有大致哑铃构型。
在替换换实施例中,工作部分可以具有大体一致的收缩传送轮廓,并配置为扩展到大体一致的较大扩展轮廓。在这种情况下,“一致”可以指不超过10%的尺寸变化。
图2A和图2B示出了示例性流体泵工作部分,其包括在径向上设置在可扩展构件内的叶轮26。图2A和图2B示出了当工作部分体外扩展时的工作部分构型。可扩展构件包括远侧区域21、中心区域22和近侧区域23。远侧区域21和近侧区域23的外形尺寸比中心区域22大,并且可扩展构件可以被认为具有哑铃构型。在使用中,中心区域22,或者其至少一部分,可以定位在瓣膜上。近侧区域23和远侧区域21分别具有渐缩端部区域,这些区域从更中心的区域的更大的外形尺寸逐渐变细。叶轮26在径向上设置在近侧区域23内,并且叶轮26的一小部分也可以在中心区域22内略微延伸。细长轴28(其可以是驱动轴或驱动线缆)联接至叶轮,并且在被启动(例如,由电机启动)时驱动叶轮26的转动。定心支柱29(示出了其中的四个)设置在叶轮26的端部,并向周围延伸,并且用于使得轴28居中。支柱29与可扩展构件联接,并围绕轴28延伸以使其稳定。位于各端的两个支柱29限定轴28延伸通过的开口。通过使轴 28居中,支柱29也使叶轮26在可扩展构件内居中,并防止叶轮叶片在旋转时与可扩展构件接合。
工作部分20还包括联接到可扩展构件的管道25。管道25从远侧区域21内的位置延伸至近侧区域23内的位置,但不延伸至可扩展构件的远侧端部和近侧端部。该管道起作用并被构型并且由在流入区域和流出端区域之间形成流体管腔的材料制成。向流入区域流入标记为“I”,在流出区域流出标记为“O”。可扩展构件包括多个细长构件,这些细长构件共同限定多个开口,流体可以通过这些开口在流入区域和流出区域流动。本文的任何管道都可以是不渗透的。可替换地,本文的任何管道都可以是半渗透的。本文的任何管道也可以是多孔的,但仍将限定通过管道的流体管腔。在一些实施例中,管道是膜或其它相对薄的分层构件。在本实施例中,管道25联接到可扩展构件的外部。工作部分的远侧端部具有大的开放的表面区域,即使该表面区域被推到贴靠(即,接触)中空解剖结构(例如,心脏的左心室)的内表面,也允许充分的血液进入流动。管道25的近侧区域作为叶轮护罩打开,以允许高效的轴向泵流量。
本文的任何管道,除非另有指示,均可被固定在可扩展构件上,使得该管道在其固定处可以在径向上位于可扩展构件的内部和/或外部。例如,管道可以在可扩展构件内径向延伸,使得管道的内表面在其固定到可扩展构件的位置在径向上位于可扩展构件内。
图2A是工作部分的示例,在该工作部分中,由于可扩展构件的构型以及管道沿可扩展构件(轴向)延伸的距离,管道具有扩口的远侧区域和近侧区域。图2A也是工作部分的示例,其远侧区域和近侧区域的外形尺寸比中心区域的外形尺寸大。
在可替换的实施例中,管道的远侧区域呈扩口构型,如喇叭口,以减少流体进入入口区域所需的工作能量。
可扩展构件可以由多种材料以多种方式构成。例如,可扩展构件可以具有编织结构,或者可以通过激光加工成形。这种材料可以是可变形的,如镍钛诺。可扩展构件可以是自扩展的,或者可以适于至少部分主动扩展。
图2A中的工作部分可以适于收缩到较小轮廓的传送构型。可扩展构件和叶轮可以适于收缩到传送构型。管道由于与可扩展构件联接而与可扩展构件一起收缩。图2B示出了图2A的视图的一部分,为了清晰示出了放大的部件。
当叶轮被启动而旋转时,旋转将流体吸入流入端,经过管道限定的管腔,并从流出端流出。
在某些实施例中,当可扩展构件从包含的管状构件(如输送导管、引导导管或通路护套)中释放时,可扩展构件适于自扩展。在一些可替换实施例中,可扩展构件适于通过主动扩展、例如拉杆将可扩展构件的远侧端部和近侧端部中的至少一者朝向彼此移动的动作进行扩展。
图3A示出了与图2A和图2B所示类似的示例性工作部分30。与工作部分20相同的部件为了清晰而没有标记,但是合并到这个图中。工作部分30包括管道31,管道31包括远侧区域32、中心区域34和近侧区域33。本实施例不同于图2A中的工作部分20之处在于,管道的远侧区域32在径向上位于可扩展构件内,且不直接附接到远侧区域32的一部分。对于工作部分跨过主动脉瓣定位的情况,例如,可扩展构件的远侧端部附近的这种布置允许原生的心脏喷射血流绕过管道的更远侧端部 (在该更远侧端部的径向外侧)并通过与管道相邻设置的主动脉瓣。管道31在可扩展构件的两端之间从外部过渡到内部,并且在本实施例中,它在可扩展构件的中心区域中过渡,该中心区域具有减小的外形尺寸。
图3B示出了与图2A和图3A所示的工作部分相似的示例性工作部分。为了清楚起见,相同的部分未重新标记,但已合并到该图中。在图 3B中,工作部分40具有在可扩展构件内径向延伸的管道,包括远侧区域41、中心区域42和近侧区域43。在远侧区域41中,存在管道仅在在径向上位于可扩展构件的内部但未与其附接的区域,如图所示。例如,在使工作部分跨过主动脉瓣定位的使用方法中,在可扩展构件的近侧端部附近的这种布置允许更多的原生心脏喷射血流绕过管道远侧端部(径向外侧)并通过邻近管道的主动脉瓣进入左右主冠状动脉,而不会被管道阻塞。
本文的流体运动设备、系统和方法可以被使用并定位在体内的各种位置。尽管本文可以提供具体示例,但是应当理解,工作部分可以定位在与本文具体描述的区域不同的身体区域中。
图4A和图4B示出了图3B中的工作部分40的示例性工作位置。工作部分40已经部署为部署构型,并跨过主动脉瓣延伸,主动脉瓣包括主动脉瓣小叶“VL”。可扩展构件的远侧区域21位于左心室“LV”,中心区域22跨过瓣膜延伸,近侧区域23位于升主动脉。如图所示,近侧区域 23的远侧端部也与小叶相接合。近侧区域23的构型和大小相对于瓣膜的开口,阻止近侧区域23通过瓣膜,以确保流出口保持在升主动脉内。远侧区域21的结构和大小防止远侧区域21通过主动脉瓣,以确保血液流入口保持在左心室内(见图4B)。从图中可以看出,工作部分在血液的流入口与血液的流出口之间的长度确保当血液的流入口设置在左心室内时血液的流出口设置在升主动脉内。
本发明还包括具有多个叶轮的工作部分。
图5示出了医疗设备的示例性工作部分200,其包括与第一电机202 联通的近侧叶轮(带有叶片201)和与第二电机202’联通的远侧叶轮(带有叶片201’)。通过将两个电机合并到流体泵中,可以使可用扭矩加倍,同时保持与单个电机相同的最大直径。这可以帮助减少设备的轮廓。在图 5所示推挽式实施例中,近侧电机202将血液吸引通过工作部分(通常包括加强细长体213,例如但不限于线圈加强的聚合物或编织加强的聚合物),而远侧电机202'推动血液通过工作部分。当用于左心室辅助时,主动脉瓣被放置在血液流入开口207和血液流出开口208之间。细长体213 在细长体213的径向外部部分上具有流入开口207,而在细长体213的径向外部部分上具有流出开口208。箭头表示血液流经开口的方向,“远侧端部”在页面的右侧。
图6A-图6C示出了工作部分300的示例性实施例,其中近侧电机302 将血液吸引通过工作部分(例如,其可以包括诸如线圈加强的聚合物或编织加强的聚合物的加强体313),同时远侧电机302'通过可扩展的侧管腔311将血液推过工作部分。近侧电机302控制并使近侧叶轮301旋转,远侧电机302’控制并使远侧叶轮301’旋转。工作部分的开口307和308 被标记。可扩展的侧管腔311可以使用机械技术进行扩展,例如,不限制于部署可扩展的大体编织结构,或简单地通过远侧叶轮301’产生的增加的压力使侧管腔膨胀。工作部分还包括远侧区域的流入开口307。侧管腔311可以配置为扩展到细长体313的一侧,这将在导管的外部产生非圆形的轮廓,或者,如可替换的图6C的截面所示,它可以更一般地围绕主加强导管扩张。沿加强体的侧面的至少一部分空间应保持暴露状态 (例如,流入开口307之一),以允许血液流入细长体313,从而支持向近侧电机302和叶轮301的流入。在用于左心室辅助时,主动脉瓣可以放置在两组血液流入开口307和血液流出开口308之间。
图7A-7E示出了具有多个叶轮的工作部分(400)的另一个示例性实施例。在该吸引-吸引式实施例中,两个叶轮分别将血液吸引通过工作部分的管腔,并将血液推过侧出口孔,如指示流动的箭头所示。孔407为流入孔,流出孔408为流出孔。因为这些叶轮吸入相对真空来输送血液,所以应加强管腔以防止或最小化收缩。图7B-图7E分别示出了图7A中所示的截面图,并且位于它们所截取的截面的下方。图7A-图7E中的实施例示出了主管腔413,其中同轴放置有电机和叶轮。主管腔413可以是线圈加强的或编织的或类似的结构加强的。次管腔411从主管腔413 向外扩展,如通过扩展的编织、支架或篮状设计,类似于图6A-图6C中的次管腔311。血液流入靠近工作部分的远侧端部。远侧电机402'和叶轮 401'驱动血液从与叶轮401'邻近或靠近的至少侧孔408处流出,如图7C 的截面图B-B所示,该截面图示出了出口孔408上方的月牙状外管腔 411。近侧电机402和叶轮401驱动血液从邻近或靠近近侧叶轮401的侧孔408流出。
图8A-图8F是工作部分(500)的另一个示例性实施例,该工作部分包括多个叶轮500和501',箭头指示流动方向。在该推-推式实施例中,工作部分500包括双电机和以推-推构型设置的叶轮,其中每个叶轮推动血液通过工作部分(511或513)的管腔,并推动血液通过侧出孔或近侧端部出孔508。因为这些叶轮产生压力来输送血液,所以管腔511和513并不一定需要加强以防止收缩,而外管腔511可以通过泵升高血压来流体膨胀。本实施例示出了电机和叶轮同轴设置于其中的主管腔513。例如,主管腔513可以是线圈加强的或编织加强的、或类似结构加强的。次管腔511可以像上面任何一个次管腔一样向外扩展,也可以通过泵升高血压来流体膨胀而向外扩展。血液流入靠近工作部分的远侧端部。管腔511 和513均从工作部分的近侧部分流出血液,例如通过侧开口508、开放的编织结构或类似的出口通道。两个叶轮501和501'可以由单个电机驱动,电机具有从各端离开的主轴,或者如图8F所示,背对背相邻的两个电机502和502'可以有效地将可用扭矩加倍来驱动血液泵送。
图9示出了医疗设备的示例性实施例,其中工作部分(600)包括多个叶轮。医疗设备包括设置在医疗设备的细长部分的近侧端部上的远程电机602。远程电机602联接至驱动线缆603,驱动线缆603联接至叶轮601和601'。电机602驱动叶轮。通过远程定位电机,可以使用比安装在合意地更小的插入式导管轴中的电机更大的电机。本文中的包括在导管内的电机的任何实施例都可以修改为具有一个或多个远程电机。工作部分600可以有多种流入和流出构型和布置,如用于每个叶轮或任一叶轮的导管侧孔608,或允许流量轴向最大化而不是径向最大化的端孔607。在叶轮之间延伸的细长体604可以例如通过夹在熔融聚合物层之间的金属丝圈或者通过大体编织的结构进行结构加强。线圈加强的设计通常比编织加强的设计具有更好的柔韧性,高度的柔韧性通常是工作部分导航到合适的位置所需要的。本实施例或本文任何其他适当的实施例还可以包括带有导管手柄的远程电机或带有联接的手柄/轮毂组合的远程电机。
图10示出了医疗设备的示例性实施例,其中工作部分(1100)包括多个叶轮。工作部分1100包括联接到电机1102'的远侧叶轮1101'。工作部分1100还包括近侧叶轮1101,其与远程电机1102联接,远程电机1102 通过驱动线缆1103进行操作的联通。远侧电机1102’位于工作部分的远侧端部附近,并驱动叶轮1101’,叶轮1101’推动血液通过工作部分的管腔,而远程的近侧电机1102驱动线缆驱动的近侧叶轮1101,近侧叶轮更靠近工作部分的近侧端部设置。在使用中,与本文中的其他工作部分一样,工作部分1100可以定位成使得主体1113在两个叶轮之间的位置跨过瓣膜(例如、如主动脉瓣)。
图11示出了医疗设备的示例性实施例,其中工作部分(1200)包括多个叶轮。工作部分1200包括与近侧叶轮1201联接的直驱式近侧电机 1202。外部电机1202'通过驱动线缆1203与远侧叶轮1201'操作联通。驱动缆线1203可以被配置在沿内部近侧电机1202延伸并与内部近侧电机1202相邻的管腔中,然后驱动缆线1203延伸到工作部分的管腔中,并被定向为大体上在管腔中居中,从而使远侧叶轮1201'在工作部分的管腔中居中。未示出可选的定心元件,例如但不限于,附接在工作部分的外壁1213与支撑旋转的驱动线缆1203的旋转轴承元件之间的两对三重支柱,从而叶轮1201'在工作部分的管腔中稳定地居中。可以使用的示例性定心支柱是图2A和图2B中的支柱29。
图12示出了医疗设备的示例性实施例,其中工作部分(1300)包括多个叶轮。该医疗设备包括分别与驱动线缆1303和1303’操作地联通的远侧电机1302和1302’。驱动线缆1303和1303’分别与近侧叶轮1301和远侧叶轮1301’操作地联通,近侧叶轮1301和远侧叶轮1301’均设置在工作部分1300内。驱动线缆1303和1303'与近侧区域1310并排设置,驱动线缆1303'沿工作部分的外围延伸一段距离,然后向管腔的中心延伸。居中元件也可以包括在内,如参照图11所描述的。驱动线缆可以位于近侧区域1310内的分离的管腔内。驱动线缆1303’可以在外管腔内,或者在一个或多个轴承元件内,其中,驱动线缆1303’沿着工作部分的外围1316 延伸。
在医疗设备(1330)包括多个叶轮的本文任何实施例中,该设备可适于使叶轮以不同速度旋转。图13A示出包括齿轮组1340的医疗设备,该齿轮组与内驱动件1338和外驱动件1336联接,内驱动件1338和外驱动件 1336分别与远侧叶轮1334和近侧叶轮1332操作地联通。该设备还包括电机1342,电机驱动内驱动件1338的旋转。内驱动件1338延伸通过外驱动件1336。电机1332的启动导致两个叶轮由于低速传动比或超速传动比而以不同的速度旋转。齿轮组1340可以适于驱动近侧叶轮或远侧叶轮比另一个更快。本文中的任何设备可以包括本文中的任何齿轮组,从而以不同的速度驱动叶轮。
图13B示出了双叶轮设备(1350)的可替换实施例的一部分,该设备也适于使不同的叶轮以不同的速度旋转。齿轮组1356与内驱动件1351和外驱动件1353联接,内驱动件1351和外驱动件1353分别与远侧叶轮 1352和近侧叶轮1354联接。该设备还包括如图13A所示的电机。图13A 和图13B示出了如何调整齿轮组以使近侧叶轮比远侧叶轮慢或快。
在可替换实施例中,一个共用的驱动线缆或驱动轴可以驱动两个(或更多个)叶轮的旋转,但两个叶轮的叶片节距(旋转曲率角)可以不同,远侧叶轮或近侧叶轮的角度比另一个叶轮更陡或更平缓。这可以产生与具有齿轮组类似的效果。图13C示出了包括联接至近侧叶轮1364和远侧叶轮1362以及未显示的电机的共用驱动线缆1366的医疗设备(1360)的一部分。本文的近侧叶轮可以比本文的远侧叶轮具有更大或更小的节距。本文的具有多个叶轮的任何工作部分都可以修改为包括具有不同节距的第一叶轮和第二叶轮。
图14示出了可以使第一叶轮和第二叶轮以不同的速度旋转的流体泵 1370的示例性可替换实施例。第一电机1382驱动联接至远侧叶轮1372 的线缆1376,而第二电机1384(通过齿轮组1380)驱动外驱动件1378,外驱动件1378联接至近侧叶轮1374。驱动线缆1376延伸通过外驱动件 1378。电机可以单独控制和操作,因此两个叶轮的速度可以单独控制。该系统设置可用于本文中包含多个叶轮的任何系统。
在使用中,本文的工作部分可以放置在脆弱结构上,如瓣膜(如主动脉瓣)。它可以有助于避免对瓣膜的损坏,并且工作部分可以适于和构造成做到这一点。因为主动脉瓣(例如,或其他类似的瓣膜)通常利用三个瓣膜靠近中心点会合而关闭,所以本文中任何工作部分的外部在工作部分横跨或跨过瓣膜的位置具有非圆形构型是有利的。非圆形导管主体旋转对齐以与主动脉瓣理想匹配可能不太满足需要。图15A、图15B和图15C 示出了本文的工作部分的示例性外部轮廓构型,该构型可以合并到本文的任何工作部分。图15D通过比较示出了圆形的外部轮廓构型。
在一些实施例中,工作部分在其跨过瓣膜的区域中可以具有顺应性或半顺应性的外部结构,使得瓣膜压在工作部分上的力将使外部结构至少部分变形以至少部分地减小了外部结构施加到瓣膜的反作用力。这可以帮助防止在其跨过瓣膜的位置损伤瓣膜。
任何工作部分的外部是光滑的也可能是有利的,以便脆弱结构(如瓣膜小叶)的任何摩擦将对这些结构造成最小的损伤。例如,在瓣膜的那个区域的支架状结构或类似的结构可能会造成可能会对瓣膜造成损伤的高斑点(如同钝的奶酪磨碎机)。尽量减少这些突出部的高度和/或尽量减少它们之间的距离可能是有益的,并可以防止对脆弱的解剖结构的损伤。
图16是示出示例性血管内流体泵的远侧部分的侧视图,其包括工作部分1600,其中工作部分1600包括近侧叶轮1606和远侧叶轮1616,近侧叶轮1606和远侧叶轮1616二者均与驱动线缆1612操作地联通。工作部分1600在图16中处于扩展的构型,但是适于收缩为传送构型,使得其可以以较小的轮廓传送。叶轮可以附接至驱动线缆1612。驱动线缆 1612与没有显示的外部电机操作地联通,并延伸通过细长轴1610。
工作部分1600还包括可扩展构件1602,在本实施例中,可扩展构件 1602的近侧端部1620比近侧叶轮1606的近侧端部向近侧延伸得更远,可扩展构件1602的远侧端部1608比远侧叶轮1616的远侧端部1614向远侧延伸得更远。可扩展构件1602沿叶轮的轴向长度在径向上设置在叶轮之外。可扩展构件1602可以以与医学领域中已知的能够收缩和扩展的许多类型的可扩展结构类似的方式构造并且由与该可扩展结构类似的材料制成,本文提供其示例。
工作部分1600还包括管道1604,管道1604联接到可扩展构件1602,具有长度L,并在叶轮之间轴向延伸。管道1604在两个叶轮之间创建并提供流体管腔。当使用时,流体流过管道1604提供的管腔。本文的管道是不渗透的,或者它们可以是半渗透的,甚至是多孔的,只要它们仍然可以限定管腔。这里的管道也是柔性的,除非另有说明。本文的管道完全围绕(即360度)工作部分的至少一部分。在工作部分1600中,管道完全围绕可扩展构件1602延伸,但不延伸至可扩展构件1602的近侧端部 1602或远侧端部1608。可扩展构件的结构创建了至少一个入口孔以允许流入“I”,并创建至少一个流出孔以允许流出“O”。相比那些没有管道的工作部分1600,管道1604改善了叶轮的泵送动力学。
可扩展构件1602可以有多种结构,并由多种材料制成,如医学领域中的任何种类的可扩展支架或类似于支架的设备,或者本文提供的任何其他示例。例如,非限制地,可扩展构件1602可以具有诸如24端编织物的开放编织结构,尽管可以使用更多或更少的编织线。用于可扩张构件的示例性材料是镍钛诺,尽管可以使用其他材料。如图所示,可扩展构件1602具有扩展构型,其中,至少在其在径向上设置在叶轮外侧的区域中的可扩展构件的外形尺寸(相对于工作部分的纵向轴线正交地测量) 大于在叶轮之间轴向延伸的可扩展构件的中心区域1622的外形尺寸。驱动线缆1612在本实施例中与纵向轴线同轴。在使用中,中心区域可以跨过瓣膜(如主动脉瓣)放置。在一些实施例中,可扩展构件1602适于和构造成在叶轮轴向位于可扩展构件内的位置扩展至12-24F(4.0-8.0mm) 的最外部尺寸,并在叶轮之间的中心区域1622处扩展至10-20F (3.3-6.7mm)的最外部尺寸。较小的中心区域的外形尺寸可以减少作用在瓣膜上的力,从而减少或最小化对瓣膜的损伤。当使用时,叶轮区域内可扩展构件的较大尺寸有助于使工作部分轴向稳定。可扩展构件1602具有大体哑铃构型。可扩展构件1602的外部构型在其从叶轮区域过渡到中心区域1622时逐渐变细,并且在可扩展构件1602的远侧端部和近侧端部再次逐渐变细。
可扩展构件1602具有联接到轴1610的近侧端部1620和连接到远侧末端1624的远侧端部1608。叶轮和驱动线缆1612在可扩展构件和管道总成内旋转。驱动线缆1612相对于远侧末端1624轴向稳定,但相对于末端1624可自由旋转。
在一些实施例中,可扩展构件1602可以通过在可扩展构件上的端部到端部的拉力而收缩。这可能包括线性运动(例如,但不限于,5-20mm 的行程),以轴向延伸可扩展构件1602至具有收缩的外形尺寸的收缩构型。可扩展构件1602也可以通过在可扩展构件/管道总成上推动外轴(如护套)而收缩,导致可扩展构件和管道收缩至其收缩传送构型。
叶轮1606和1616也适于和构造成,使得一个或多个叶片将拉伸或径向压缩到缩小的最外部尺寸(与工作部分的纵向轴线正交测量)。例如,非限制地,本文中的任何叶轮均可包括一个或多个由具有弹簧特性的塑料配方制成的叶片,如美国专利No.7,393,181中描述的任何叶轮,其公开内容通过引用并入本文,并且可以并入本文的实施例中,除非本公开内容表明相反的情况。可替换地,例如,一个或多个可收缩叶轮可以包括超弹性线框,该线框具有作为横跨线框的织带的聚合物或其他材料,例如在美国专利No.6,533,716中描述的,该美国专利No.6,533,716的公开内容通过引用并入本文。
工作部分1600的流入和/或流出构型本质上可以是主要为轴向的。
收缩和扩展医疗设备的示例性套护套和脱护套的技术和概念是已知的,例如,在美国专利No.7,841,976或美国专利No.8,052,749中描述和示出的,其公开内容通过引用并入本文。
图17是示出流体运动系统的示例性实施例的远侧部分的部署构型 (体外)的侧面图。示例性系统1100包括工作部分1104和从工作部分1104 延伸的细长部分1106。细长部分1106可以延伸到系统的更近侧区域(为了清晰没有示出),更近侧区域可以包括例如电机。工作部分1104包括沿工作部分1104的纵向轴线LA轴向间隔的第一可扩展构件1108和第二可扩展构件1110。在该上下文中的轴向间隔是指整个第一可扩展构件沿纵向轴线LA与整个第二可扩展构件轴向间隔。第一可扩展构件1108 的第一端1122与第二可扩展构件1110的第一端1124轴向间隔。
第一可扩展构件1108和第二可扩展构件1110通常各自包括相对于彼此设置的多个细长段,以限定多个开口1130,在第二可扩展构件1110 中仅标记了一个开口。可扩展构件可以具有多种构型,并且可以以多种方式构造,诸如但不限于美国专利No.7,841,976中的任何构型或构造,或美国专利No.6,533,716中的管,其被描述为自扩展金属内假体材料。例如但不限于,可扩展构件中的一个或两个可以具有编织结构或可以通过激光切割管状元件至少部分地形成。
工作部分1104还包括连接到第一可扩展构件1108和第二可扩展构件1110的管道1112,并在部署构型中在第一可扩展构件1108和第二可扩展构件1110之间轴向延伸。管道1112的中心区域1113跨越轴向距离 1132,在该轴向距离1132中工作部分不包含第一可扩展构件1108和第二可扩展构件1110。中心区域1113可以被认为是可扩展构件之间的轴向区域。管道1112的远侧端部1126不能向远侧延伸至第二可扩展构件 1110的远侧端部1125,管道1128的近侧端部不能向近侧延伸至第一可扩展构件1108的近侧端部1121。
当本文的公开内容提到连接到可扩展构件的管道时,上下文中术语“联接”不要求管道直接附接到可扩展构件上使得管道与可扩展构件物理接触。然而,即使没有直接附接,上下文中术语“联接”指的是管道和可扩展构件接合在一起,使得随着可扩展构件扩展或收缩,管道也开始向不同的构型和/或大小转变。因此,上下文中术语“联接”指的是指当管道联接的可扩展构件在扩展构型和收缩构型之间转变时管道将移动。
本文的任何管道都可以在一定程度上变形。例如,管道1112包括细长构件1120,该细长构件可以由一种或多种材料制成,当工作部分1104 朝向图17所示的构型部署时,该材料允许管道的中心区域1113响应于例如在使用时来自瓣膜组织(例如小叶)或替代瓣膜的力时在径向上向内(朝LA)变形一定程度。在某些实施例中,管道可以在可扩展构件之间紧密地拉伸。可替换地,管道可以设计成具有导致更大程度的顺应性的松散度。当工作部分设置成跨过脆弱结构(如主动脉瓣)时,这是可取的,这样可以使主动脉瓣以最小化脉瓣内的点应力的方式压缩管道。在某些实施例中,管道可以包括附接至近侧可扩展构件和远侧可扩展构件的膜。可用于本文任何管道的示例性材料包括但不限于聚氨酯橡胶、硅橡胶、丙烯酸橡胶、膨胀的聚四氟乙烯、聚乙烯、聚对苯二甲酸乙二醇酯,包括其任何组合。
本文的任何管道都可以有例如0.5-20千分之一英寸(密耳,thou) 的厚度,例如1-15thou、或1.5-15thou、1.5-10thou、或2-10thou的厚度。
本文的任何管道,或管道的至少一部分,都可以不渗血。在图17中,工作部分1104包括从管道1112的远侧端部1126延伸至管道1112的近侧端部1128的管腔。管腔是由位于中心区域1113的管道1112限定,但可以认为是由管道和可扩展构件的位于与中心区域1113轴向邻近的区域中的部分限定。然而,在本实施例中,是管道材料导致管腔存在并阻止血液通过管道。
除非有相反的指示,否则本文中固定到一个或多个可扩展构件的任何管道都可以被固定成使得管道设置在一个或多个可扩展构件的径向外部,设置在一个或多个可扩展构件的径向内部,或者设置在一个或多个可扩展构件的径向外部并且设置在一个或多个可扩展构件的径向内部,并且可扩展构件可以用管道材料浸渍。
近侧和远侧的可扩展构件帮助维持管道处于开放构型以创建管腔,同时每个可扩展构件也为叶轮创建工作环境,如下所述。在部署构型时,每个可扩展构件与各自的叶轮保持间隔关系,这使得叶轮在可扩展构件内旋转而不与可扩展构件接触。工作部分1104包括第一叶轮1116和第二叶轮1118,第一叶轮1116在径向上设置在第一可扩展构件1108内,第二叶轮1118在径向上设置在第二可扩展构件1110内。在本实施例中,两个叶轮虽然是不同的、单独的叶轮,但它们与共同的驱动机构(例如,驱动线缆1117)操作地联通,以便当驱动机构被启动时,两个叶轮一起旋转。在这种部署构型中,叶轮1116和1118沿纵向轴线LA轴向间隔,正如可扩展构件1108和1110轴向间隔一样。
(除了在径向上位于可扩展构件1108和1110内)叶轮1116和1118也分别轴向位于可扩展构件1108和1110的两端内。本文的叶轮可以被认为轴向在可扩展构件内,即使可扩展构件包括从可扩展构件的中心区域向工作部分的纵向轴线延伸的支柱(例如,侧视图中的渐缩支柱)。在图 17中,第二可扩展构件1110从第一端1124(近侧端部)延伸至第二端1125(远侧端部)。
在图17中,叶轮1118的远侧部分向远侧延伸至管道1112的远侧端部1126之外,叶轮1116的近侧部分向近侧延伸至管道1112的近侧端部 1128之外。在此图中,每个叶轮的一部分在部署构型中在轴向上设置在管道内。
在图17所示的示例性实施例中,叶轮1116和1118与共用驱动机构 1117操作地联通,并且在本实施例中,叶轮分别与驱动机构1117联接,该驱动机构延伸通过轴1119和工作部分1104。驱动机构1117可以是例如细长的驱动线缆,当旋转时,该驱动线缆导致叶轮旋转。在本示例中,如图所示,驱动机构1117延伸至远侧末端1114,并相对于远侧末端1114 轴向固定,但驱动机构适于在被驱动时相对于远侧末端1114旋转。因此,在本实施例中,当驱动机构旋转时,叶轮和驱动机构1117一起旋转。任何数量的已知机构都可以用来旋转驱动机构,如利用电机(例如,外部电机)。
可扩展构件和管道与叶轮和驱动机构不处于旋转操作的联通中。在本实施例中,近侧可扩展构件1108的近侧端部1121与轴1119联接,轴 1119可以是细长部分1106的轴(例如,外导管轴)。近侧可扩展构件1108 的远侧端部1122与中心管状构件1133联接,驱动机构1117延伸通过该中心管状构件1133。中心管状构件1133在管道1112内从近侧可扩展构件1108向远侧延伸,并与远侧可扩展构件1110的近侧端部1124联接。因此,驱动机构1117在中心管状构件1133内部相对于中心管状构件1133 旋转。中心管状构件1133从近侧可扩展构件1108轴向延伸至远侧可扩展构件1110。远侧可扩展构件1110的远侧端部1125与远侧末端1114 连接,如图所示。驱动机构1117适于相对于末端1114旋转,但相对于末端1114轴向固定。
工作部分1104适于且配置成收缩到比其部署构型更小的轮廓(如图 17所示)。与工作部分1104都不可收缩所需的情况相比,这使得允许它使用较小轮廓的传送设备(较小的法国尺寸)传送。即使本文没有特别说明,可扩展构件和叶轮中的任一者可以适于和配置为在一定程度上收缩至更小的传送构型。
本文的工作部分可以使用传统技术收缩成收缩的传送构型,例如使用相对于工作部分可移动的外护套(例如,通过轴向移动护套和工作部分的一者或两者)。例如,但不限于,下列参考文献中所示的系统、设备或方法中的任一者均可用于促进本文工作部分的收缩:美国专利 No.7841,976或美国专利No.8,052,749,其公开内容通过引用并入本文。
图18A-图18D 示出了在某些方面与图17所示的工作部分类似的示例性工作部分。工作部分340与工作部分1104的相似之处在于,其包括当工作部分扩展时彼此轴向间隔的两个可扩展构件以及在这两个可扩展构件之间延伸的管道。图18A是透视图,图18B是侧向剖视图,图18C 和图18D是图18B中的视图的各部分的特写侧向剖视图。
工作部分340包括近侧叶轮341和远侧叶轮342,它们与驱动线缆联接并与驱动线缆进行可操作地联通,驱动线缆中限定内腔。内腔大小配置成容纳导丝,导丝可用于将工作部分输送到所需位置。在本实施例中,驱动线缆包括第一部分362(例如卷绕材料)、与近侧叶轮341联接的第二部分348(如管状构件)、第三部分360(例如卷绕材料)、与远侧叶轮342联接的第四部分365(如管状材料)。驱动线缆的各部分内径相同,使得内腔的内径恒定。驱动线缆的各部分可以使用已知的附接技术彼此固定。第四部分365的远侧端部延伸至工作部分的远侧区域,以允许工作部分例如在用于定位工作部分的导丝上前进。在本实施例中,第二部分和第四部分可以比第一部分和第三部分更硬。例如,第二部分和第四部分可以是管状的,第一部分和第三部分可以是卷绕材料,以提供更少的刚度。
工作部分340包括近侧可扩展构件343和远侧可扩展构件344,每一构件在其中一个叶轮之外径向延伸。可扩展构件具有远侧端部和近侧端部,这些远侧端部和近侧端部也向轴向延伸超出叶轮的远侧端部和近侧端部,如图18B-图18D所示。连接到两个可扩展构件的是管道356,其具有近侧端部353和远侧端部352。两个可扩展构件分别包括多个近侧支柱和多个远侧支柱。近侧可扩展构件343中的近侧支柱延伸到并固定到轴部分345,轴部分345联接到轴承361,驱动线缆延伸穿过轴承361 并且被配置成和尺寸设计成能够旋转。近侧可扩展构件343的远侧支柱延伸到并固定到中心管状构件346的近侧区域(在本例中为近侧端部),中心管状构件346在轴向上设置在可扩展构件之间。中心管状构件346的近侧端部与轴承349联接,如图18C所示,驱动线缆通过轴承349延伸和旋转。远侧可扩展构件344的近侧支柱延伸到并固定到中心管状构件 346的远侧区域(在本例中为远侧端部)。轴承350也连接到中心管状构件 346的远侧区域,如图18D所示。驱动线缆延伸通过轴承350并相对于轴承350旋转。远侧可扩展构件的远侧支柱延伸至轴部分347并固定在轴部分347上(见图18A),轴部分347可以认为是远侧末端的一部分。轴部分347连接到轴承351(见图18D),驱动线缆延伸通过轴承351并相对于轴承351旋转。远侧末端还包括轴承366(见图18D),其可以是止推轴承。工作部分340在某些方面与工作部分1104相似或相同,即使没有明确包括在说明书中。在本实施例中,管道356至少延伸到叶轮的端部,不像工作部分1104。可以修改任一实施例,使得管道延伸到如另一实施例中所述的位置。在一些实施例中,部分360可以是管状部分而不是卷绕部分。
虽然本文中可能示出了具体的示例性位置,但流体泵可能可以用于体内的各种位置。放置的一些示例性位置包括放置在主动脉瓣或肺动脉瓣附近,例如跨过脉瓣并定位在脉瓣的一侧或两侧,并且在主动脉瓣的情况下,可选地包括位于升主动脉的部分。例如,在其他一些实施例中,泵可能在使用中位于更下游的位置,例如设置在降主动脉中。
图19示出了来自图17的系统1000的工作部分1104的示例性位置。图19所示的不同之处在于,管道至少延伸到叶轮的端部,与图18A-图 18D所示类似。图19示出了跨过主动脉瓣就位的处于部署构型的工作部分1104。如图所示,工作部分1104可以例如通过股动脉通路(一种已知的通路手术)进行传送,但不限于此。虽然为了清楚没有显示,系统1000 也可以包括外护套或轴,在该外护套或轴中,工作部分1104在传送过程中设置在主动脉瓣附近的位置。护套或轴可以向近侧端部移动(向升主动脉“AA”移动,且远离左心室“LV”),以允许工作部分1104的部署和扩展。例如,可以将护套收回,以允许第二可扩展构件1110扩展,并且继续向近侧端部移动允许第一可扩展构件1108扩展。
在本实施例中,第二可扩展构件1110已扩展并定位于部署构型,使得远侧端部1125位于左心室“LV”,并位于主动脉瓣小叶“VL”的远侧,以及远侧端部位于椎间盘(annulus)的远侧。近侧端部1124也被放置在小叶VL的远侧端部,但在某些方法中,近侧端部1124可能在小叶VL 内略微轴向延伸。本实施例是第二可扩展构件1110的沿其长度测量(沿纵向轴线测量)的至少一半位于左心室内的方法的示例。如图所示,这也是整个第二可扩展构件1110位于左心室内的方法的示例。这也是第二叶轮1118的至少一半位于左心室内的方法的示例,也是整个第二叶轮1118 位于左心室内的实施例。
外轴或外护套的持续缩回(和/或工作端1104相对于外轴或外护套向远侧端部移动)继续释放管道1112,直到中心区域1113被释放和部署。可扩展构件1108和1110的扩展使得管道1112呈现更加开放的构型,如图19所示。因此,虽然在本实施例中管道1112不具有与可扩展构件相同的自扩展特性,但当工作端部署时,管道将呈现部署的、更开放的构型。管道1112的中心区域1113的至少一部分位于主动脉瓣合拢区域。在图18中,有一小段中心区域1113向远侧延伸超出小叶VL,但中心区域1113的至少一部分轴向位于小叶内。
外轴或外护套的持续缩回(和/或工作端1104相对于外轴或外护套向远侧端部移动)部署第一可扩展构件1108。在本实施例中,第一可扩展构件1108已被扩展并定位(如图所示)在部署构型中,使得近侧端部1121 位于升主动脉AA中,并位于小叶“VL”的近侧。远侧端部1122也位于小叶VL的近侧,但在某些方法中,远侧端部1122可以在小叶VL内稍微轴向延伸。本实施例是第一个可扩展构件1110的沿其长度测量(沿纵向轴线测量)的至少一半位于升主动脉内的方法的示例。如图所示,这也是整个第一可扩展构件1110都在AA中的方法的示例。这也是第一叶轮 1116至少一半定位在AA内的方法的示例,也是将整个第一叶轮1116 定位在AA内的实施例。
在工作部分1104部署期间或部署后的任何时间,工作部分的位置可以通过任何方式进行评估,例如在荧光透视下。工作部分的位置可以在部署期间或部署后的任何时间进行调整。例如,在释放第二可扩展构件 1110之后,但在释放第一可扩展构件1108之前,可以轴向(向远侧或近侧)移动工作部分1104来重新定位工作部分。此外,例如,工作部分可以在整个工作部分从护套释放到所需的最终位置后重新定位。
可以理解,图19中显示的部件的位置(相对于解剖结构)被认为是工作部分1104的不同部件的示例性最终位置,即使在最初部署后发生了重新定位。
本文中的一个或多个可扩展构件可以构造成扩展的并且可以以多种方式扩展,例如通过自扩展、机械致动(例如,在可扩展构件上的一个或多个轴向定向的力,利用单独的球囊扩展,该球囊在径向上位于可扩展构件内并膨胀以径向向外推动可扩展构件),或其组合。
本文使用的扩展通常是指重新配置为具有更大的径向最外部尺寸(相对于纵向轴线)的更大轮廓,而不管一个或多个部件扩展的具体方式。例如,自扩展的并且/或者受到径向向外的力的支架就可以像本文使用的术语一样“扩展”。展开或张开的设备也可以呈现较大的轮廓,并且可以认为如本文使用的术语一样扩展。
叶轮也可以类似地适于和配置成可以根据其结构以多种方式进行扩展。例如,一个或多个叶轮在从护套释放后,由于叶轮的材料和/或结构设计,可以自动恢复到或朝向不同的更大的轮廓构型(例如参见,美国专利No.6,533,716,或美国专利No.7,393,181,两者均通过引用并入本文)。因此,在一些实施例中,外部约束的缩回可以允许可扩展构件和叶轮自然地回复到更大的轮廓的部署构型,无需任何进一步的驱动。
如图19中的示例所示,工作部分包括在主动脉瓣的两侧间隔开的第一叶轮和第二叶轮,每个叶轮均设置在单独的可扩展构件内。这与其中工作部分包括单个细长的可扩展构件的一些设计相反。不是单个大致管状的可扩展构件一直跨过脉瓣延伸,而是工作端1104包括在可扩展构件 1108和1110之间延伸的管道1112。该管道比可扩展篮更柔韧和可变形,与可扩展构件跨越主动脉瓣小叶所发生的情况相比,这可以允许在小叶位置处的工作部分更大的变形。在工作部分已经部署在受试者中之后,这可以对小叶造成较少的损伤。
此外,从小叶施加在单个可扩展构件的中心区域上的力可能会轴向传递到可扩展构件的其他区域,这可能会在一个或多个叶轮的位置上造成可扩展构件的不希望的变形。这可能导致外侧的可扩展构件与叶轮接触,不希望地干扰叶轮的旋转。包括围绕每个叶轮的单独的可扩展构件的设计,特别是每个可扩展构件和每个叶轮在两端被支撑的设计,导致在相对于可扩展构件定位叶轮时具有高精度。与单个可扩展构件相比,两个单独的可扩展构件可以更可靠地保持其部署构型。
如上所述,可取的是能够重新配置工作部分,使其能够在9F的护套内传送,并在使用时仍然获得足够高的流速,这对于目前正在开发和/或测试的一些产品是不可能的。例如,一些产品太大,无法重新配置为足够小的传送轮廓,而一些较小的设计可能无法实现所需的高流速。图16、图17、图18A-图18D和图19中的示例的示例性优势在于,例如,第一叶轮和第二叶轮可以一起工作以实现所需的流速,并且通过具有两个轴向间隔的叶轮,与使用单个叶轮实现所需流速的设计相比,整个工作部分可以重新配置为更小的传送轮廓。因此,这些实施例使用了多个较小的、可重新配置的叶轮,这些叶轮在轴向上间隔开,以实现所需的较小的传送轮廓以及所需的高流速。
因此,本文的实施例可以在保持足够高的流速的同时实现更小的传送轮廓,同时创建工作部分的更可变形和更柔性的中心区域,其示例性优点如上所述(例如,与娇弱的瓣膜小叶接合)。
图20A、图20B和图20C示出了工作部分的示例性远侧端部结构和构型,并可被合并到本文中的任何工作部分或现有技术中已知的其他工作部分中。图20A-图20C示出了示例性远侧末端特征,如果末端靠在血流阻断结构(如左心室顶端)上,这些特征可能有助于促进血流,并有助于跨过主动脉瓣的正确定位。
图20A示出了示例性工作部分1502,其具有流入孔1508和流出孔 1510以及带有远侧端部1506的远侧末端1504。末端1504可以具有足够强度的猪尾形结构,以防止在推动心脏组织(如左心室组织)时收缩。末端1504还可以包括更硬的内部导线(比远侧末端的外部材料更硬)。
图20B示出了示例性工作部分1512,该工作部分包括末端1516和与末端1516相邻且在末端1516的近侧的流入部分1514。流入部分1514 包括多个元件1518,这些元件限定了多个孔,这些孔使得即使被推靠到心脏组织(如左心室组织)上时仍然允许足够的血流。流入部分1514可以配置为通过织造或编织金属丝或激光切割管状构件而形成的支架或类似支架的装置。流入部分1514可以由例如自扩展材料组成,如镍钛诺。
图20C示出了包括末端1524的示例性工作部分1520,末端1524包括具有第一整体构型的多个第一流入开口1526以及具有与第一整体构型不同的第二整体构型的多个第二流入开口1522。所述多个开口被配置成即使在末端被推靠到心脏组织上时也允许足够的血液流动。
在任何实施例中,多个流入开口或孔可以通过粘合、溶剂焊接、超声波焊接、激光焊接或使用类似的工艺成型到与工作部分的其余部分附连的末端件的设计中。额外的孔可以使用例如但不限于核心钻孔或激光加工添加到粘合的末端附近。
图21A示出了部署的工作部分1520的示例性位置,其中工作部分的长度是这样的,通过推动工作部分向前,直到其与左心室(LV)组织相结合,从而达到跨过主动脉瓣的适当位置,如图所示。在这个位置,流入开口1522、1526在左心室,流出孔1528设置在升主动脉,工作部分的中心区域沿主动脉瓣小叶VL延伸。
图21B和图21C示出了工作部分的可替换远侧区域,这些远侧区域不包括像20A-20C和21A中那样的猪尾形构型。这些末端区域可以合并到本文任何适当的工作部分或本领域已知的任何其他工作部分。图21B 示出了示例性的末端区域,该区域包括可扩展构件1612,例如自扩展的类似支架的结构,其可以像本文中的任何可扩展构件一样形成。可扩展构件1612具有多个细长元件,这些细长元件定义多个流入开口。这些开口限定了足够的开放空间,以防止限制血液流动和最小化溶血,同时也允许足够的血液流动,即使构件1612被推靠例如左心室的壁的结构或甚至是左心室的顶点。构件1612可以有多种构型,例如水滴形或圆形(例如,长度等于直径,或高达直径的几倍)。在本实施例中,构件1612位于工作部分的最远侧端部。
图21C示出示例性工作部分的包括远侧末端1602的部分,远侧末端 1602包括进入开口1604和位于工作部分的最远侧端部的一个或多个可膨胀构件1619。可膨胀构件1619位于工作部分的最远侧端部。例如图 21C所示的可膨胀末端可以是大致球形的,或者可选地是泪珠形的,因此,更近侧端部具有最少或没有可能会卡住腱索或心脏内的类似结构的特征、或位于血管分支附近的其他特征或其他此类中空解剖结构的特征。
本文的叶轮适于从部署的、扩展构型收缩到收缩的、较小的外形尺寸构型,除非有相反的指示。这有助于最小化整个工作部分的传送轮廓,并且扩展到有助于生成所需流速的更大的外形尺寸大小。
图22A和图22B示出了示例性叶轮1701的端部视图,其叶片1720 处于收缩构型(图22A)和扩展构型(图22B)中。叶轮包括中心构件1721,叶片1720从中心构件1721径向延伸。在图22B的扩展构型中,叶片相对于中心构件1721进一步向外径向延伸。刀片可以由自扩展到更大的外形尺寸的材料制成,如聚合材料(如聚乙烯、聚丙烯、聚酯、ABS、尼龙、缩醛、聚苯硫醚)、硅树脂或具有聚合物织带的超弹性圆形截面耐纶丝制成。
图23A-图23C示出了示例性叶轮1801,其叶片1820分别在其中包括配重元件1822。配重元件1822可以是更高密度(例如,钨,不锈钢) 的配重元件或具有比叶片其余部分更大的厚度的区域。因此,在后面的实施例中,元件1822可以是叶片的一部分,而不是单独的部件。通过比较图23B中的部署构型和在图23C中看到的旋转过程中的操作构型可以看出,更大的密度或更大的厚度将导致叶轮叶片因离心反应而向外拉。
图24A和图24B分别示出了具有叶片1922的叶轮1901的收缩构型和可操作构型。叶轮叶片1922被配置成以这样的方式捕获流体流,即,推向叶片的表面的血液的反作用力驱动叶轮叶片从较小扩展的形状扩展为较大扩展的形状。
本文的一些工作部分可以包括多个管腔,每个管腔都是流体(如血液) 可以通过其流动的流体管腔。双管腔工作部分可以用于例如双电机设计。也可以合并两个以上的管腔,因此也可以合并两个以上的电机。图25A 和图25B示出了处于收缩的传送构型(图25A)和扩展构型(图25B) 的示例性多管腔(管腔1922和1924)工作部分1920。较小的收缩轮廓使传送轮廓较小,但可以扩展到较大尺寸,以允许所需的较高流速,例如4-6L/min。管腔可以扩展的示例性方式包括编织的篮状结构的扩展,通过升高的血压使管腔膨胀,或两者的结合。
图26A和图26B示出了分别显示了部署构型和扩展构型的工作部分的示例性多管腔设计。工作部分50包括嵌入了矩阵结构52(如编织结构)的外体51。隔膜53穿过工作部分的内部并从外体51向内径向延伸,分隔管腔54和55。隔膜53和外体51是柔性的,并且随着外体51从收缩的较小的外形尺寸向部署的较大的外形尺寸扩展而拉伸变薄(如图所示)。材料的选择将考虑到这些特性。本实施例中的外部轮廓为圆形。
在一些相关实施例中,可以包括额外的管腔,以容纳例如电机接线,流体压力测量装置和/或导丝。图27A-图27C示出了具有这种附加管腔的示例性实施例。图27A示出了示例性工作部分,其具有外壁60、隔膜61、通道62、由通道62限定的管腔63、第一流体管腔64和第二流体管腔 65。管腔63和通道62在隔膜61内。在图27 B中,管腔73和通道72 设置在管腔64和管腔65之间的相交处。工作部分包括壁70、隔膜71、流体管腔74和流体管腔75。图27 C示出了设置在壁80的外围的通道82 和管腔83以及相邻的隔膜81。
图28示出了示例性概念,其中,工作部分90包括可扩展构件93,该可扩展构件93包括多个细长段92(仅标记了一个)。工作部分90还示出了如何将布线和/或管腔91(仅标记一个,但是为了不同的目的可以包括一个以上)结合到可扩展构件(例如,编织结构)中。这里,布线和/或管腔91以曲线的方式沿着可扩展构件的外围从近侧部分到远侧部分。当然,工作部分的其他部件(例如,叶轮,管道)可以与可扩展构件93结合。在该实施例中,可扩展构件的扩展不会拉伸布线和/或管腔。
现在,本公开内容描述了一些示例性的磁耦合设计,其可以与本文的任何合适的工作部分和医疗设备结合。磁耦合是电机的部分,其可以驱动本文的一个或多个叶轮的旋转。图29示出了示例性的流体运动医疗设备100,其包括工作部分102、磁耦合105、电机108、轴113和一根或多根电线109。图29中的实施例的示例性优势在于,电机可以相对容易地重复使用,用于将来的手术。壳体114容纳电机108、电线109的远侧部分,轴113和磁性构件107。工作部分包括流入端101、末端104、叶轮112和出口103。使用后,可以从壳体114上取下工作部分102,并且可以在可选的切割区域111切割或切断壳体114。这将分离电机,使其重复使用。此设计还允许使用无血的电机,这对于在设备再处理中重新使用该部件可能特别有帮助。可以创建切割区域111,以促进电机108 和相关布线的移除而不会造成损坏。
图30示出了用于电机和驱动线缆的示例性磁耦合。该磁耦合布置可以用于医疗设备的近侧端部附近,以在驱动电机和驱动线缆之间提供间接接触间隙。这种布置允许无菌屏障封闭包括驱动电机的非无菌处理单元,以使驱动电机磁耦合到无菌导管轴连接器。这提供了以下的优势:非无菌的手柄和线缆组件可以在许多医疗手术中使用和重复使用,而不需要作为多用途组件进行清洗、消毒和灭菌。包括工作部分的一次性使用的导管组件和一次性使用的无菌屏障可以用于每个手术。
图30示出了医疗设备的电机壳体128和导管部分123之间的近侧耦合122。导管部分123包括本文中任何合适的工作部分,或本领域中已知的其他工作部分。电机壳体128包括联接到磁性构件125的电机126。无菌套管127可以在电机壳体128上前进。导管部分123包括磁性构件 124和驱动线缆121。电机的启动导致驱动线缆通过磁耦合122旋转。
如果磁耦合与本文的任何医疗设备一起使用,则可能需要更大的扭力杠杆臂。因此,可能有利的是,更大的磁耦合器轮以90度角安装在导管轴上,以实现低高度(因此小体积)的封装。图31示出了这样的一个实施例,其中使用90度的齿轮组联接到驱动线缆。为了清晰起见,图31 仅示出了该设备的一部分。电机133与第一磁性构件131联接。驱动线缆135和第二磁性构件132联接到90度齿轮组134。
在一些实施例中,工作部分可以具有大体直形的末端,以便于插入体内,然后将末端偏置成大体L形或J形,以便于导航并减少对血管内结构或心内结构的潜在创伤。可以通过使用插入工作部分管腔(如导丝腔)的硬质弯曲构件实现次级远侧端部构型。可替换地,可以通过远侧末端附近的可操纵导管机构(例如在工作部分的壁内的一个或多个拉线) 来实现次级远侧端部构型。图32A示出了示例性工作部分140,其包括管腔区域141和处于大体直形构型的远侧末端142。图32B示出了内部细长构件143,例如导丝,其穿过工作部分140前进并进入远侧末端142。在此实施例中,先前直形的末端142持久地呈“J”形构型。
图33A-图33E示出了工作部分的示例性远侧端部,可以将其并入本文中任何合适的工作部分或本领域已知的其他工作部分中。在图33A中,工作部分190包括管道191和可扩展构件192。可扩展构件192包括多个细长元件,其包括从元件199向近侧延伸的渐缩支柱193。支柱193 可以与元件199成一体或可以与其联接。支柱193限定入口孔195(仅标记一个),以使血液流入工作部分管腔。可扩展构件192的远侧端部包括:第一区域198,在第一区域198中至少一个孔具有第一面积;第二区域197,在第二区域197中至少一个孔具有中间面积;和第三区域 196,在第三区域196中至少一个孔具有第三面积,其中第一面积大于中间面积,并且中间面积大于第三面积。
图33B与图33A相似,图33A的描述通过引用并入图33B的描述中。工作部分220包括支柱222,然而,支柱222径向向外延伸,然后径向向内延伸。工作部分220还包括可以联接至叶轮的细长构件223和接口元件224。
图33C中的工作部分230与图33A和图33B相似,图33A和图33B 的描述通过引用合并到图33C的描述中。然而,工作部分230包括具有曲线构型的远侧末端231,远侧末端231中包括多个孔232。末端231具有远侧端部233。
图33D中的工作部分240类似于图33A-图33C,图33A-图33C的描述通过引用结合到图33D的描述中。然而,工作部分240包括支柱243,支柱243逐渐变细并在工作部分的远侧端部彼此相遇。工作部分240不具有如图33A-图33C所示的向远侧延伸的单独的末端部分。工作部分240 还包括相对于构件242固定的轴241。
图33E中的工作部分250与图33A-图33D相似,图33A-图33D的描述是通过引用并入图33E的描述。然而,工作部分250包括具有圆形构型的远侧延伸部251,其可以是球形、环形、蛋形等。远侧延伸部251 中具有多个孔253,并且远侧延伸部251可以通过连接器部分252与支柱254整体成形。
图34示出了类似于图16所示的工作部分的工作部分。工作部分265 包括近侧叶轮266、远侧叶轮267,两者均联接至驱动轴278,驱动轴278 延伸到远侧轴承壳体272。在工作部分的近侧端部有一个类似的近侧轴承壳体。工作部分还包括大体称为270的可扩展构件、以及固定在可扩展构件上并延伸几乎可扩展构件的整个长度的管道268。可扩展构件270包括延伸至并固定至支柱支撑件273的远侧支柱271,该支柱支撑件273 固定至远侧末端273。可扩展构件270还包括近侧支柱,近侧支柱固定至近侧支柱支撑件。即使未明确说明,与图16所示相似的所有特征也通过引用结合到该实施例中。可扩展构件265还包括螺旋拉伸构件269,螺旋拉伸构件269沿着可扩展构件的外围设置并且当可扩展构件处于所示的扩展构型时具有螺旋形构型。螺旋拉伸构件269被设置成并且适于在收缩时引起旋转缠绕。工作部分265可以从所示的扩展构型收缩,同时以相对较低的速度同时旋转一个或两个叶轮,以促进叶轮由于与可扩展构件的相互作用而卷曲收缩。螺旋拉伸构件269(或多个可扩展构件单元的螺旋布置)将充当共同拉伸构件,并配置为使得当可扩展篮沿其长度方向拉紧以收缩时(例如通过拉伸到更大的长度,例如长度的大约两倍)将拉伸构件269拉成更直的线形,这会导致在收缩期间使可扩展构件的所需段旋转/扭曲,从而导致叶轮叶片随着可扩展构件和叶片的收缩而径向向内卷绕。这种拉伸构件的示例性构型当处于螺旋形式时将具有近似等于可扩展构件在收缩时的最大长度的曲线构型。在可替换实施例中,仅使可扩展构件的包围可收缩叶轮的部分在收缩时旋转。
还有可替换的方式来构造工作部分,以在由细长件收缩时引起可扩展构件的旋转(并因此引起叶轮叶片的卷绕和收缩)。即使在双叶轮设计中,任何可扩展构件都可以构造有该特征。例如,对于包括多个“单元”的可扩展构件,如该术语所公知的(例如,激光切割的细长构件),可扩展构件可以具有多个特定的单元,这些单元共同限定特定的构型,例如螺旋形构型,其中限定该构型的单元具有与可扩展构件中的其他单元不同的物理特性。在一些实施例中,可扩展构件可以具有编织结构,并且扭曲区域可以构成整个线材组,或者编织线材的大部分(例如,一半以上)。例如,可以在编织过程中实现这种扭曲的编织结构,例如,通过随着特别是沿着编织结构的最大直径部分的长度拉动心轴而使线材被编织到其上的心轴扭曲。该结构还可以在构造过程的第二操作期间实现,例如在成形的心轴上热定型伤口轮廓之前机械地扭曲编织结构。
图35示出了本文的任何多叶轮泵设计的可替换实施例,其中具有两个端部半刚性叶轮282和在叶轮叶片285之间的螺旋柔性壁283,该螺旋柔性壁283被配置为具有与输送血液的叶片的螺距相同的螺距,类似于阿基米德螺杆。在另一个实施例中,沿着柔性壁的长度有多个径向支撑件,以防止柔性壁在扭曲时收缩到叶轮驱动轴286上,这是柔性管的正常趋势。
对于本文的任何一个猪尾形末端,猪尾形末端可以有不同的壁厚,以促进不同的性能。例如,在示例性实施例中,在猪尾形的最远侧区域中有较薄的壁厚,在该最远侧区域的近侧设置的区域中有较厚的壁厚。
图36示出了具有显示器290的示例性泵控制台,该显示器290可以与本文中的任何流体泵一起使用。控制台包括速度显示元件、叶轮旋转指示元件、估计的血流速显示器293、传感器显示器294(如血压读数)、电池图标、流体泵电子设备和/或清理连接295。
在一些实施例中,导管的电连接和流体连接被集成到单个连接器中,该连接器配置为例如通过磁引力与控制台连接。在可替换实施例中,电连接与流体连接分开。在这样的实施例中,这些连接可以彼此相邻以作为统一的一对连接器进行连接。在一些实施例中,控制台适于感测连接器中的一个或两个是否恰当地且完全地配合。
在一些实施例中,流体夹带用于引导血流,如通过注射盐水。其他示例性流体是葡萄糖溶液或血液。夹带是流体通过剪切诱导的湍流通量在两个流体之间的界面上的输送,但重要的是可能由湍流通量引起的溶血最小化。
本公开包括用于确认本文的工作部分的正确定位的设备和方法。在一些实施例中,例如,一个或多个超声晶体(如压电晶体)被包括在本文的任何工作部分中。超声晶体可用于指示流体运动,如血流,也可以用于检测主动脉瓣和/或二尖瓣的运动。此类传感器的示例性位置靠近工作部分的血液流出口和工作部分的血液流入口。在一种使用方法中,可以通过传感器测量血流的方向和湍流度,并与参考数据进行比较,以确定工作部分是否位于血液流入口和流出口之间的瓣膜(如主动脉)。如果所述感知信息没有指示正确的放置,则工作部分可以移动,直到传感器感应到正确的放置的指示。在升主动脉内,血液主要从主动脉瓣流向降主动脉。相反,心室内部有更多变化的或循环的流动方向,因为随着心室肌肉的每一次压缩,心室腔被充满和部分排空。主动脉瓣小叶的运动也可以呈现可以识别为超声晶体通过的可识别模式。这些方法可以与本文中的任何方法一起使用。
在一些实施例中,医疗设备包括微型摄像机(例如,联接到工作部分或仅在工作部分的近侧),以便在工作部分放置和确认期间直接查看解剖,并在需要时移动。在示例性实施例中,一个或多个摄像机位于工作部分的流出口的近侧,以便当摄像机直接穿过主动脉瓣时用户可以直接查看工作部分的远侧端部。设置在导管轴上的可见标记可以进一步指示,导管放置在与瓣膜(如主动脉瓣)有关的位置上更好(例如,定位工作部分使得瓣膜位于血液流入口和流出口之间)。在一些实施例中,摄像机系统适于通过充血的血管(如主动脉)可视化,例如通过具有通过血液的总光耗最小的波长辐射。示例性的波长在红外光谱范围内。在一些实施例中,波长的辐射至少部分地被心血管表面或导管表面反射和反向散射,检测反射的和反向散射的辐射的所有强度信号,并通过选择仅由血液反向散射的辐射的强度信号来处理检测到的信号,并从所有检测到的反射的和反向散射的辐射的强度信号中减去选择的仅由血液反向散射的辐射的强度信号,以便使用通过减去获得的差值强度信号重建心血管或导管表面的图像。
在本文的任何相关实施例中,铁磁流体可以用作轴承或密封件,以防止血液进入工作部分轴承和/或电机组件。在一些实施例中,在设备的气体灭菌期间,铁磁流体被包含在单独的储存器或通道中,然后被释放或注入到磁场中以填充预期的空间从而充当轴承和/或密封件。在一些实施例中,包含铁磁流体的储存器包括通过流体接触而溶解的膜,例如通过用盐水冲洗设备或通过血液接触来溶解,使得当膜溶解时,铁磁流体被释放到适当位置。
在一些实施例中,手柄中的驱动电机可以由热电冷却器(TEC)冷却,其中来自TEC的热端的热通过散热片或流体循环而消散。可替换地,可以通过暴露在空气中的多个散热片来冷却手柄中的驱动电机。散热片可以通过空气驱动风扇驱动空气通过散热片。
在一些实施例中,扭矩反馈可以用于确定血液流入口和流出口是否位于脉瓣(例如主动脉瓣)的相对侧。测量扭矩反馈的示例性方法是直接观察跨过脉瓣定位的工作部分的位置和流速以及完全位于心室/升主动脉内流入口/流出口的位置和流速,以确定根据叶轮转速变化的扭矩边界。这些边界可用于确认流入口和流出口在主动脉瓣的相对侧。
在本文的任何相关实施例中,工作部分可以具有在远侧叶轮和近侧叶轮之间的一个或多个流体出口孔,以使流体出口孔可以支撑系统中的心脏动脉,在该系统中,远侧叶轮部分位于左心室内,近侧叶轮系统位于升主动脉内。
本文的工作部分的血液流出端可以包括适于捕获血栓和/或碎屑的过滤器。
在一些实施例中,第一叶轮(例如,远侧叶轮或近侧叶轮)可以固定地紧固至驱动线缆,并且第二叶轮(例如,远侧叶轮或近侧叶轮)可以配置成当系统收缩时沿着驱动线缆滑动(例如,向近侧或近侧)。然而,可滑动叶轮被配置为在系统扩展时与固定叶轮机械地接合。该机械接合可以通过带有齿轮端或带槽端的中间管来实现,以便中间管将扭矩从第一叶轮传递到第二叶轮。在可替换实施例中,三个或更多个叶轮可被类似地配置,其中一个叶轮被附接到驱动线缆,并且其余叶轮与附接的叶轮机械地接合。
当执行传送、定位和使用中的任何方法时,还可以以任何组合执行以下任何附加步骤。以下的可选步骤描述了可以作为pVAD手术的一部分执行的一些临床步骤或过程。
可以执行的示例性过程是测量活化的凝血时间(“ACT”)或部分凝血活酶时间(“PTT”)以评估抗凝作用。在本文的任何实施例中, ACT或PTT传感器可以被并入或附接到流体泵送装置,诸如在其上的工作部分上。ACT和/或PTT可以在以下任何或所有时间段内进行测量:在插入流体设备之前,在使用流体设备期间(例如,每4至8小时),在去除流体泵之后以及在移除护套之前。当发生溶血时,血红蛋白和血细胞比容减少,触珠蛋白减少,血浆游离血红蛋白增加。
可以执行的另一示例性步骤是验证没有由于阻塞而发生进入部位肢体缺血。在本文的任何实施例中,一个或多个用于血流速度的传感器可以位于流体泵导管上或动脉通路护套或静脉通路护套上。
可以执行的另一示例性步骤是定期评估动脉进入部位的出血或血肿。在本文的任何实施例中,动脉通路护套或静脉通路护套可以包括一个或多个适于检测血管进入部位的出血或血肿的传感器。
取决于所使用的设备及其定位方法,可以执行的另一示例性步骤是验证工作部分是否已正确推进并跨过瓣膜定位(例如,参见图18,该图示出了跨主动脉瓣的定位)。例如,荧光检查可以用来确认左心室中和跨过主动脉瓣的工作部分的正确位置。感测到的压力也可以用于验证正确的定位。例如,可以对心室波形和主动脉波形进行评估。另外,在较高的流速下,或者如果心室功能不佳,患者的血流可能是非脉动的。电机电流信号还可用于确定正确的定位。例如,如果工作部分的流入口和流出口在左心室或主动脉中,或者心室功能不佳,则电机电流信号会变平。例如,过程引擎可以监视电机电流的非典型模式,该非典型模式与流体从泵的流出口到流入口的再循环相关。另外,该泵可以适于验证心室中没有抽吸。
可以执行的另一示例性步骤是评估主动脉瓣损伤的指示。例如,一个或多个应变仪传感器可以在工作部分跨过脉瓣(例如主动脉瓣)的区域中定位在工作部分上。
可以执行的另一示例性步骤是感测由流体泵输送的血液流速。例如,一个或多个流速传感器可以是设置在与工作部分紧邻的设备上的工作部分的一部分。例如,可以将超声晶体传感器放置在设备上或设备内,例如在工作部分上或工作部分内部,并对准以测量由工作部分推动的血流量。附加地或可替换地,多普勒晶体可以用于测量在工作部分内流动或流出工作部分的血液速度。
可以执行的另一示例性步骤是感测一个或多个叶轮的旋转速度,并将其与血流速相关联。
可以执行的另一示例性步骤是,可选地频繁地验证患者没有血液动力学不稳定。例如,泵血系统可以包括多个心电图导线,以测量指示心脏功能(例如心脏跳动)的电信号的传导。
可以执行的另一示例性步骤是执行连续心输出量监测,这对于患有心源性休克的患者可能是有用的。例如,诸如工作部分的流体泵送设备可以包括一个或多个传感器,例如热稀释传感器,以指示心脏射血分数和/或心脏指数。
在某些用途中,在放置流体泵以维持至少2的心脏指数和90毫米汞柱或更高的收缩压后,可能仍需要正性肌力药(例如多巴酚丁胺和米力农)以及升压药(例如多巴胺和去甲肾上腺素)。
如果患者需要询问永久性起搏器或植入式心律转复除颤器,则可以在建立信号时关闭流体泵控制台几秒钟。例如,流体泵内的所有潜在电触点与患者都电隔离,因此在流体泵系统与有源植入式电子设备(如起搏器或植入式心律转复除颤器)之间不存在电干扰的可能性。
本文任何方法的一部分是验证没有并发症,例如没有回流,没有低血压和没有致死性心律不齐。
在一些实施例中,可以执行经胸廓超声心动图(TTE)以评估例如左心室大小和功能。
在一些实施例中,患者的定位要考虑到通气和血栓形成/溃疡的预防。
在某些用途中,可以监视电机和/或线缆的温度以指示血液进入/烧焦。
在一些实施例中,一个或多个应变传感器可以被结合到任何可扩展构件中,并且可以被用于测量可可扩展构件的部署。
Claims (32)
1.一种血管内血泵,包括:
可部署的远侧工作部分,所述远侧工作部分在部署构型中包括:
远侧可扩展构件,其具有收缩的传送构型、以及部署构型,所述远侧可扩展构件具有近侧端部和远侧端部;
在径向上和轴向上设置在所述远侧可扩展构件内的远侧叶轮;
近侧可扩展构件,其具有收缩的传送构型、以及部署构型,所述近侧可扩展构件具有近侧端部和远侧端部,其远侧端部与所述远侧可扩展构件的近侧端部轴向隔开;
近侧叶轮,其在径向上和轴向上设置在所述近侧可扩展构件内,所述近侧叶轮朝向近侧与所述远侧叶轮隔开;
管道,其联接至所述远侧可扩展构件和所述近侧可扩展构件并且在所述远侧可扩展构件的近侧端部与所述近侧可扩展构件的远侧端部之间轴向延伸,所述管道至少部分地限定了在所述管道的远侧端部和所述管道的近侧端部之间的血流管腔,
其中,所述管道的中心区域跨越轴向距离,且所述远侧可扩展构件和所述近侧可扩展构件不轴向延伸进所述中心区域,
其中,所述远侧可扩展构件的远侧端部比所述管道的远侧端部进一步向远侧延伸,并且所述近侧可扩展构件的近侧端部比所述管道的近侧端部进一步向近侧延伸;和
从所述工作部分向近侧延伸的细长部分。
2.根据权利要求1所述的血泵,其中,所述近侧可扩展构件的远侧端部联接至中心管状元件的近侧端部,并且所述远侧可扩展构件的近侧端部联接至所述中心管状元件的远侧端部,所述中心管状元件设置在所述管腔中并在所述近侧可扩展构件和所述远侧可扩展构件之间延伸。
3.根据权利要求2所述的血泵,其中,所述中心管状元件在所述收缩的传送 构型和所述部署构型中都具有相同的最外部尺寸。
4.根据权利要求1所述的血泵,其中,所述近侧叶轮和所述远侧叶轮由共用驱动机构驱动。
5.根据权利要求4所述的血泵,其中,所述共用驱动机构包括共用驱动线缆。
6.根据权利要求5所述的血泵,其中,所述共用驱动线缆联接到所述近侧叶轮和所述远侧叶轮。
7.根据权利要求5所述的血泵,其中,所述共用驱动线缆包括联接到第二部分的第一部分,所述第一部分与所述第二部分相邻,所述第一部分和所述第二部分具有共同的纵向轴线和相对于该共同的轴线正交测量的共同的外部尺寸,其中所述第一部分比所述第二部分硬,并且所述远侧叶轮或所述近侧叶轮联接到所述第一部分。
8.根据权利要求7所述的血泵,其中,所述第一部分包括第一管状构件,所述第二部分包括卷绕构件。
9.根据权利要求8所述的血泵,其中,所述驱动线缆还包括与所述第二部分相邻的第三部分,所述第三部分与所述远侧叶轮和所述近侧叶轮中的另一者联接。
10.根据权利要求4所述的血泵,其中,所述共用驱动机构限定管腔,该管腔能够可选地用作导丝管腔。
11.根据权利要求1所述的血泵,其中,所述远侧叶轮和所述近侧叶轮与共同的电机操作地联通。
12.根据权利要求1所述的血泵,其中,所述远侧可扩展构件联接至远侧轴承和近侧轴承,其中驱动机构延伸通过所述远侧轴承和所述近侧轴承。
13.根据权利要求1所述的血泵,其中,所述近侧可扩展构件与远侧轴承和近侧轴承联接,其中,驱动机构延伸通过所述远侧轴承和所述近侧轴承。
14.根据权利要求1所述的血泵,其中,所述远侧可扩展构件包括相对于彼此设置以限定多个孔的多个细长段,其中所述多个孔之一的至少一部分在所述管道的远侧端部的远侧,从而限定允许血液进入所述管腔的至少一个血液入口孔。
15.根据权利要求14所述的血泵,其中,所述近侧可扩展构件包括相对于彼此设置以限定多个第二孔的多个细长段,其中所述多个第二孔之一的至少一部分位于所述管道的近侧端部的近侧,从而限定允许血液从所述管腔排出的至少一个出口孔。
16.根据权利要求1所述的血泵,其中,所述远侧可扩展构件和所述近侧可扩展构件中的至少一个具有多个编织的细长段。
17.根据权利要求1所述的血泵,其中,所述管道是不渗透的。
18.根据权利要求1所述的血泵,其中,所述管道是半渗透的。
19.根据权利要求1所述的血泵,其中,所述管道由这样的材料制成,使得在所述远侧可扩展构件和所述近侧可扩展构件之间的轴向中心区域中,该材料适于响应于作用在所述工作部分上的径向向内的力而比所述可扩展构件更容易地径向向内变形。
20.根据权利要求1所述的血泵,其中,所述管道在沿着所述近侧可扩展构件的相对于所述近侧可扩展构件的纵向轴线正交地测量的最大径向尺寸的位置处联接至所述近侧可扩展构件,并且,所述管道在沿着所述远侧可扩展构件的相对于所述远侧可扩展构件的纵向轴线正交地测量的最大径向尺寸的位置处联接至所述远侧可扩展构件。
21.根据权利要求1所述的血泵,其中,所述管道在其联接至所述近侧可扩展构件的位置处在径向上设置在所述近侧可扩展构件内,并且,所述管道在其联接至所述远侧可扩展构件的位置处在径向上设置在所述远侧可扩展构件内。
22.根据权利要求21所述的血泵,其中,所述管道在其联接至所述近侧可扩展构件的位置处也在径向上设置在所述近侧可扩展构件之外,并且所述管道在其联接至所述远侧可扩展构件的位置处也在径向上设置在所述远侧可扩展构件之外。
23.根据权利要求21所述的血泵,其中,所述近侧可扩展构件具有在径向上向内和向远侧逐渐变细的远侧部分,并且所述远侧可扩展构件具有在径向上向内和向近侧逐渐变细的近侧部分,并且其中,所述管道在所述远侧部分中的第一位置处仅在径向上设置在所述近侧可扩展构件之外,并且不在所述第一位置处直接联接至所述近侧可扩展构件,并且其中,所述管道仅在所述近侧部分中的第二位置处在径向上设置在所述远侧可扩展构件之外,并且不在所述第二位置处直接联接至所述远侧可扩展构件。
24.根据权利要求1所述的血泵,其中,在所述部署 构型中,所述远侧叶轮的远侧端部不比所述管道的远侧端部向远侧延伸更远。
25.根据权利要求1所述的血泵,其中,在所述部署 构型中,所述近侧叶轮的近侧端部不比所述管道的近侧端部向近侧延伸更远。
26.根据权利要求1所述的血泵,其中,所述管道是柔性的。
27.根据权利要求1所述的血泵,其中,在所述部署构型中,所述近侧叶轮比所述管道的近侧端部进一步向近侧延伸。
28.根据权利要求1所述的血泵,其中,在所述部署构型中,所述远侧叶轮比所述管道的远侧端部进一步向远侧延伸。
29.根据权利要求1所述的血泵,其中,在所述部署构型中,所述管道的第一部分仅在径向上设置在所述近侧可扩展构件之外,并且其中,所述管道的在所述管道的第一部分近侧的第二部分在径向上设置在所述近侧可扩展构件之内。
30.根据权利要求29所述的血泵,其中,所述管道的第一部分位于所述近侧叶轮的远侧端部的远侧。
31.根据权利要求1所述的血泵,其中,所述管道的第一部分仅在径向上设置在所述远侧可扩展构件之外,并且,所述管道的位于所述管道的第一部分的远侧的第二部分在径向上设置在所述远侧可扩展构件之内。
32.根据权利要求31所述的血泵,其中,所述管道的第一部分在所述远侧叶轮的近侧端部的近侧。
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