CN111556763B - 血管内流体运动装置、系统 - Google Patents

血管内流体运动装置、系统 Download PDF

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CN111556763B
CN111556763B CN201880084350.7A CN201880084350A CN111556763B CN 111556763 B CN111556763 B CN 111556763B CN 201880084350 A CN201880084350 A CN 201880084350A CN 111556763 B CN111556763 B CN 111556763B
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impeller
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CN111556763A (zh
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A·萨拉希
T·索尔
B·埃施
A·科洛
D·希尔德布兰德
D·瓦加伊
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Shifamed Holdings LLC
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
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    • A61M60/808—Vanes or blades specially adapted for deformable impellers, e.g. expandable impellers
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/414—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
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    • A61M60/818—Bearings
    • A61M60/825—Contact bearings, e.g. ball-and-cup or pivot bearings
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
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    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
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    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart

Abstract

用于使患者体内的血液运动的装置以及这样做的方法。所述装置可以包括泵部分，泵部分包括叶轮和围绕叶轮的壳体，以及流体腔。叶轮可以被激活以使得叶轮旋转，从而使流体腔内的流体运动。

Description

血管内流体运动装置、系统
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，其公开出于所有目的通过引用全部并入本文：2017年11月13日提交的申请No.62/585,155；2017年12月19日提交的申请No.62/607,878；和2018年2月23日提交的申请No.62/634,769。
通过引用并入
本说明书中提及的所有公开文献和专利申请以引用的方式并入本文，其程度等同于每个单独的公开文献或专利申请被具体地和单独地指示以引用方式并入。
背景技术
有心脏病的患者可能会严重损害驱动血液流过心脏和血管系统的能力，例如在矫正手术过程(比如球囊血管成形术和支架递送)期间存在重大风险。需要为这些患者改善(尤其是矫正手术过程期间)心出流的体积或稳定性的方法。
主动脉内气囊泵(IABP)通常用于支持循环功能，比如治疗心力衰竭患者。IABP的用途通常是治疗心力衰竭患者，比如在高危经皮冠状动脉介入治疗(HRPCI)期间支持患者、稳定心源性休克后的患者血流、治疗与急性心肌梗死(AMI)相关的患者或者治疗失代偿性心力衰竭。这样的循环支持可以单独使用或与药物治疗一起使用。
IABP通常通过放置在主动脉内并随着心脏收缩以反搏的方式充气和放气而起作用，其功能之一是试图为循环系统提供额外的支持。
最近，已开发出微创旋转式血泵，可以将其与心血管系统相关地插入体内，比如将动脉血从左心室泵入主动脉，以增加患者心脏左侧的天然血液泵送能力。另一已知方法是将静脉血从右心室泵送到肺动脉，以增加患者心脏右侧的天然血液泵送能力。总体目标是减少患者心肌上的工作负荷以稳定患者，比如在可能给心脏施加额外应力的医疗过程中，在心脏移植之前稳定患者或为患者提供持续支持。
目前可用的最小旋转式血泵可以通过管路护套(从而无需手术干预)或通过血管管路移植被经皮插入患者的血管系统。这种类型的装置的描述是经皮插入的心室支持装置。
需要对用于治疗受损心脏血流的心室支持装置和类似血泵领域提供其他改进。
发明内容
本发明的一个方面是一种血管内血泵，包括：包括流体腔的壳体(可选地，可折叠(collapsible))，所述流体腔具有远端(可选地，与入流邻近)和近端(可选地，与出流邻近)；与近侧叶轮(可选地，可折叠)轴向间隔开的远侧叶轮(可选地，可折叠)，所述远侧叶轮和所述近侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间，其中所述远侧叶轮具有在扩展状态下的扩展配置，所述近侧叶轮具有在扩展状态下的扩展配置，以及其中所述远侧叶轮的所述扩展配置与所述近侧叶轮的所述扩展配置不同。
所述远侧叶轮可以具有远侧叶片，所述近侧叶轮可以具有近侧叶片，其中所述远侧叶片具有与所述近侧叶片不同的节距。所述远侧叶片可以是多个远侧叶片中的一个，并且所述近侧叶片可以是多个近侧叶片中的一个，其中所述多个远侧叶片可以具有与所述多个近侧叶片中的每一个近侧叶片均不同的节距。
所述近侧叶轮可以被成形、确定尺寸和定位来主要提供离心流，所述远侧叶轮可以被成形和确定尺寸来主要提供轴向流。
所述远侧叶轮和近侧叶轮可以适于且被配置为使流体在相同方向上运动。
本发明的一个方面是一种血管内血泵，包括：包括流体腔的壳体(可选地，可折叠)，所述流体腔具有远端(可选地，与入流邻近)和近端(可选地，与出流邻近)；与近侧叶轮(可选地，可折叠)轴向间隔开的远侧叶轮(可选地，可折叠)，所述远侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间，其中所述近侧叶轮的近端在所述壳体处于扩展配置以及在所述近侧叶轮处于扩展配置时被布置在所述流体腔的所述近端的近侧。
所述远侧叶轮的远端可以在所述可折叠壳体处于扩展配置以及在所述可折叠远侧叶轮处于扩展配置时被布置得不比所述流体腔的所述远端更远。
本发明的一个方面是一种在受试者中定位血管内血泵的方法，包括：将泵壳体流体腔第一端定位在左心室中；将所述血泵的远侧叶轮定位在所述左心室中；将所述血泵的近侧叶轮定位在升主动脉中；将泵壳体流体腔第二端定位在所述升主动脉中；将所述流体腔的中心区域的至少一部分跨越主动脉瓣定位，所述中心区域在所述近侧叶轮的远端与所述远侧叶轮的近端之间延伸，在定位在所述左心室中的所述流体腔第一端与定位在所述升主动脉中的所述流体腔第二端之间产生流动路径，使得所述远侧叶轮和所述近侧叶轮可以通过所述流体腔泵送血液。
所述方法还可以包括：通过激活所述远侧叶轮在所述远侧叶轮处产生轴向流，并且通过激活所述近侧叶轮在出流处产生流动，所述流动具有离心分量和轴向分量。
本发明的一个方面是一种血管内血泵，包括：包括流体腔的壳体，所述流体腔具有远端和近端；与近侧叶轮轴向间隔开的远侧叶轮，所述远侧叶轮和所述近侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间；并且所述近侧叶轮具有远端，所述远侧叶轮具有近端，其中所述流体腔在所述近侧叶轮的所述远端与所述远侧叶轮的所述近端之间的沿着所述壳体的纵向轴线的长度为从1.5cm至25cm。在一些示例性实施例中，该距离可以为从2cm至20cm、从2cm至15cm、从2cm至10cm、从2cm至8cm、从2cm至7cm、或从2cm至6cm。
所述壳体可以是可折叠壳体，所述近侧叶轮可以是可折叠叶轮，所述远侧叶轮可以是可折叠叶轮。
所述血泵还可以包括被轴向布置在所述近侧叶轮与所述远侧叶轮之间的至少一个流动扩散器，其中所述至少一个流动扩散器被配置为减小所述流体腔中的流体在所述远侧叶轮与所述近侧叶轮之间的涡流。
本发明的一个方面是一种血管内血泵，包括：包括流体腔的可折叠壳体，所述流体腔从流体腔第一端和流体腔第二端延伸；与可折叠近侧叶轮轴向间隔开的可折叠远侧叶轮，所述可折叠远侧叶轮和所述可折叠近侧叶轮的至少一部分被轴向布置在所述流体腔的所述流体腔第一端与所述流体腔第二端之间；所述近侧叶轮具有远端，所述远侧叶轮具有近端；并且至少一个流动扩散器被轴向布置在所述近侧叶轮远端与所述远侧叶轮近端之间，其中所述至少一个流动扩散器被配置为减小所述流体腔中的流体在所述远侧叶轮与所述近侧叶轮之间的涡流。
所述近侧叶轮的所述远端与所述远侧叶轮的所述近端之间的沿着所述可折叠壳体的纵向轴线的距离是从1.5cm至25cm。该距离可以为从2cm至20cm、或从2cm至15cm、或从2cm至10cm、或从2cm至8cm、或从2cm至7cm、或从2cm至6cm。
所述可折叠壳体在扩展状态下可以具有在所述近侧叶轮远端与所述远侧叶轮近端之间形成于其中的弯曲部，使得所述壳体的在所述弯曲部远侧的远侧区域与所述壳体的在所述弯曲部近侧的近侧区域沿着一轴线不轴向对准。
本发明的一个方面是一种血管内血泵，包括：可折叠壳体，其包括从远端延伸至近端的流体腔；与可折叠近侧叶轮轴向间隔开的可折叠远侧叶轮，所述可折叠远侧叶轮和所述可折叠近侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间；所述近侧叶轮具有远端，所述远侧叶轮具有近端，所述壳体在扩展状态下具有在所述近侧叶轮远端与所述远侧叶轮近端之间形成于其中的弯曲部，使得所述壳体的在所述弯曲部远侧的远侧区域与所述壳体的在所述弯曲部近侧的近侧区域沿着一轴线不轴向对准。
所述血泵还可以包括被轴向布置在所述近侧叶轮与所述远侧叶轮之间的至少一个流动扩散器，其中所述至少一个流动扩散器被配置为减小所述流体腔中的流体在所述远侧叶轮与所述近侧叶轮之间的涡流。
附图说明
图1是包括导管、多个叶轮、可扩展构件的示例性工作部分的侧视图。
图2是包括导管、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3A、图3B、图3C和图3D示出包括导管、多个叶轮和多个可扩展构件的示例性工作部分。
图4示出工作部分的示例性放置，工作部分包括导管、多个可扩展构件和多个叶轮。
图5示出示例性工作部分。
图6A示出具有泵部分的示例性医疗装置的至少一部分，其中至少两个不同的叶轮可以以不同的速度旋转。
图6B示出具有泵部分的示例性医疗装置的至少一部分，其中至少两个不同的叶轮可以以不同的速度旋转。
图6C示出示例性医疗装置的至少一部分，该示例性医疗装置具有泵部分，泵部分带有节距不同的至少两个叶轮。
图7示出具有泵部分的示例性医疗装置的至少一部分。
图8示出具有多个叶轮的泵部分，在相邻的叶轮之间在其中形成有弯曲部。
图9示出具有多个叶轮的泵部分。
具体实施方式
本发明涉及医疗装置、系统、以及使用和制造方法。本文的医疗装置可以包括适于布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，本文的远侧工作部分可以包括一个或多个旋转构件，该旋转构件在旋转时可以促进诸如血液的流体的运动。
本文中与系统、装置或使用方法的方面有关的任何公开可以与本文中任何其他合适的公开合并。例如，即使在本发明的一个或两个部分的描述中没有具体说明，也可以将仅描述装置或方法的一个方面的图包括在其他实施例中。因此，应当理解，除非另外明确指出，否则本发明的不同部分的组合均包括在本文中。
图1是示出包括泵部分1600的示例性血管内流体泵的远侧部分的侧视图，其中，泵部分1600包括近侧叶轮1606和远侧叶轮1616，这两者均与驱动缆线1612可操作地连通。泵部分1600在图1中处于扩展配置，但适于折叠成递送配置，以便其可以以较小外形进行递送。叶轮可以附接到驱动缆线1612。驱动缆线1612与外部电动机(未示出)可操作地连通，并延伸通过细长轴1610。除非相反指出，否则短语“泵部分”和“工作部分”(或其派生词)在本文中可以互换使用。例如但不限于，“泵部分”1600在本文中也可以称为“工作部分”。
泵部分1600还包括可扩展构件1602，在该实施例中，可扩展构件具有比近侧叶轮1606的近端更向近侧延伸的近端1620、和比远侧叶轮1616的远端1614更向远侧延伸的远端1608。可扩展构件1602沿着叶轮的轴向长度布置在叶轮的径向外侧。可扩展构件1602可以以与医学领域中已知的能够折叠和扩展的许多类型的可扩展结构(本文中提供了其示例)类似的方式构造并且由类似材料制成。合适材料的例子包括但不限于聚氨酯和聚氨酯弹性体。
泵部分1600还包括导管1604，其联接到可扩展构件1602，长度为L，并且在叶轮之间轴向延伸。导管1604在两个叶轮之间产生并提供流体腔。在使用时，流体运动通过由导管1604提供的内腔。本文的导管是不可渗透的、或者它们可以是半渗透的、或者甚至是多孔的，只要导管仍然可以限定内腔即可。除非另外指出，否则本文的导管也是柔性的。本文的导管完全地(即，360度)围绕泵部分的至少一部分延伸。在泵部分1600中，导管完全地围绕可扩展部件1602延伸，但并未一直延伸到可扩展构件1602的近端1602或远端1608。可扩展部件的结构产生允许入流“I”的至少一个入口孔和允许出流“O”的至少一个出流孔。与没有导管的工作部分1600相比，导管1604改善了叶轮泵送动力。
可扩展构件1602可以具有多种构造，并且可以由多种材料制成。例如，可扩展构件1602可以与可扩展支架或支架状装置或本文提供的任何其他示例类似地形成。例如但不限于，尽管可以使用更多或更少的编织线材，但是可扩展构件1602可以具有诸如24端编织物之类的开放编织结构。可扩展构件的示例性材料包括镍钛诺、钴合金和聚合物，但是也可以使用其他材料。如图所示，可扩展构件1602具有扩展配置，其中可扩展构件的外部尺寸(相对于工作部分的纵向轴线正交地测量)在至少其被径向布置在叶轮外侧的区域中比在可扩展构件1622的在叶轮之间轴向延伸的中心区域1622中大。在该实施例中，驱动缆线1612与纵向轴线同轴。在使用中，中心区域可以跨瓣膜(比如，主动脉瓣)放置。在一些实施例中，可扩展构件1602适于并构造成扩展至叶轮轴向地在可扩展构件内的最外尺寸12-24F(4.0-8.0mm)，以及至叶轮之间的中心区域1622中的最外尺寸10-20F(3.3-6.7mm)。较小的中心区域外部尺寸可以减小作用在瓣膜上的力，从而可以减少或最小化对瓣膜的损坏。叶轮的区域中的可扩展构件的较大尺寸可以在使用时帮助轴向地稳定工作部分。可扩展构件1602具有大体哑铃的配置。可扩展构件1602具有在其从叶轮区域过渡到中心区域1622时渐缩并且在可扩展构件1602的远端和近端处也渐缩的外部配置。
可扩展构件1602具有联接至轴1610的近端1620和联接至远侧末端1624的远端1608。叶轮和驱动缆线1612在可扩展构件和导管组件内旋转。驱动缆线1612相对于远侧末端1624被轴向地稳定，但是相对于末端1624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从一端到另一端的拉力来折叠。这可以包括线性运动(比如，例如但不限于5-20mm的行程)以将可扩展构件1602轴向地延伸至具有折叠的外部尺寸的折叠配置。也可以通过在可扩展构件/导管组件上推动诸如护套之类的外轴来使可扩展构件1602折叠，使可扩展构件和导管向其折叠递送配置折叠。
叶轮1606和1616还适于并构造成使得一个或多个叶片将拉伸或径向压缩至减小的最外尺寸(正交于工作部分的纵向轴线测量)。例如但不限于，本文的任何叶轮均可以包括一个或多个由具有弹簧特性的塑料配方制成的叶片，比如美国专利No.7,393,181中描述的任何叶轮，其公开出于所有目的被并入本文并可以并入本文的实施例中，除非本发明具有相反指示。替代地，例如，一个或多个可折叠叶轮可以包括超弹性线材框架，其具有充当跨越线材框架的带子的聚合物或其他材料，比如在美国专利No.6,533,716中所描述的那些，其公开出于所有目的通过引用合并于此。
实际上，工作部分1600的入流和/或出流配置可以大部分是轴向的。
折叠和扩展医疗装置的示例性入套和出套技术以及构思是已知的，比如，例如在美国专利No.7,841,976或美国专利No.8,052,749中描述和示出的那些，其公开内容通过引用并入本文。
图2是示出流体运动系统的示例性实施例的远侧部分的展开配置(体外示出)的侧视图。示例性系统1100包括工作部分1104(如本文所述，其也可以在本文中被称为泵部分)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(为清楚起见未显示)，并且可以包括例如电动机。工作部分1104包括沿工作部分1104的纵向轴线LA轴向地间隔开的第一可扩展构件1108和第二可扩展构件1110。轴向地间隔开在此上下文中是指整个第一可扩展构件与整个第二可扩展构件沿着工作部分1104的纵向轴线LA轴向地间隔开。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轴向地间隔开。
第一和第二可扩展构件1108和1110通常各自包括相对于彼此布置的多个细长段，以限定多个孔1130，在第二可扩展构件1110中仅标记了一个孔。可扩展构件可以具有各种各样的配置并且可以以各种方式构造，比如，在例如但不限于美国专利No.7,841,976中的配置或构造或者No.6,533,716号中的管子(其被描述为一种自扩展金属内假体材料)中的任一个。例如但不限于，可扩展构件中的一个或两者可以具有编织构造，或者可以至少部分地通过激光切割管状元件而形成。
工作部分1104还包括导管1112，该导管1112联接至第一可扩展构件1108和第二可扩展构件1110，并且在展开配置中在第一可扩展构件1108与第二可扩展构件1110之间轴向延伸。导管1112的中心区域1113横跨其中工作部分没有第一可扩展构件1108和第二可扩展构件1110的轴向距离1132。中心区域1113可被认为是轴向地在可扩展构件之间。导管1112的远端1126没有向远侧延伸到如第二可扩展构件1110的远端1125那么远，并且导管1128的近端没有向近侧延伸到如第一可扩展构件1108的近端1121那么远。
当本发明在本文中涉及导管联接至可扩展构件时，该上下文中术语联接不要求导管直接附接至可扩展构件，使得导管物理地接触可扩展构件。但是，即使未直接附接，该上下文中的术语联接指的是导管和可扩展构件连接在一起，使得随着可扩展构件扩展或折叠，导管也开始转变为不同的配置和/或尺寸。因此，该上下文中的联接是指当与其联接的可扩展构件在扩展配置与折叠配置之间转变时将会运动的导管。
本文中的任何导管都可以在一定程度上变形。例如，导管1112包括细长构件1120，该细长构件1120可以由这样的一种或多种材料制成：该材料允许导管的中心区域1113对例如在使用中当工作部分1104向图2所示的配置展开时来自瓣膜组织(例如，小叶)或替换瓣膜的力作出响应而在径向上向内(朝向LA)变形到一定程度。在一些实施例中，导管可以在可扩展构件之间紧紧地拉伸。替代地，导管可以被设计为具有松度，从而导致更大程度的顺应性。这在工作部分跨越易碎结构(比如，主动脉瓣)布置时会是理想的，这可以允许瓣膜以使得瓣膜中的点应力最小化的方式压缩导管。在一些实施例中，导管可以包括附接到近侧和远侧可扩展构件的膜。可用于本文中的任何导管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、膨化聚四氟乙烯、聚乙烯、聚对苯二甲酸乙二醇酯，包括其任意组合。
本文中的任何导管的厚度可以为例如.5至20千分之一英寸(thou)，例如1至15thou、或1.5至15thou、1.5至10thou、或2至10thou。
本文中的任何导管或导管的至少一部分可以是血液不可渗透的。在图2中，工作部分1104包括从导管1112的远端1126延伸并延伸到导管1112的近端1128的内腔。该内腔由中心区域1113中的导管1112限定，但是可以认为由导管和可扩展构件在轴向上邻近中心区域1113的区域中的部分这两者限定。然而，在该实施例中，是导管材料导致了内腔存在并防止血液通过导管。
除非有相反的指示，否则本文中固定至一个或多个可扩展构件的任何导管都可以被固定为使得导管径向地布置在一个或多个可扩展构件的外部、径向地布置在一个或多个可扩展构件的内部、或两者兼而有之，并且可扩展构件可以以导管材料浸渍。
近侧和远侧可扩展构件有助于将导管保持在打开配置以产生内腔，同时每个构件还为叶轮产生工作环境，如下文所述。当处于展开配置时，每个可扩展构件相对于各自的叶轮保持间隔开的关系，这允许叶轮在可扩展构件内旋转而不接触可扩展构件。工作部分1104包括第一叶轮1116和第二叶轮1118，其中第一叶轮1116径向地布置在第一可扩展构件1108内，第二叶轮1118径向地布置在第二可扩展构件1110内。在该实施例中，两个叶轮即使是分开且单独的叶轮，也与共同的驱动机构(例如，驱动缆线1117)可操作地连通，使得在驱动机构被激活时，两个叶轮一起旋转。在这种展开配置中，叶轮1116和1118沿着纵向轴线LA轴向地间隔开，正如可扩展构件1108和1110轴向地间隔开一样。
叶轮1116和1118也分别轴向地位于可扩展构件1108和1110的端部内(除了径向地位于可扩展构件1108和1110内以外)。即使可扩展构件包括从可扩展构件的中心区域朝向工作部分的纵向轴线延伸的支柱(例如，在侧视图中为锥形支柱)，本文的叶轮也可以被认为是轴向位于可扩展构件内。在图2中，第二可扩展构件1110从第一端1124(近端)延伸到第二端1125(远端)。
在图2中，叶轮1118的远侧部分向远侧延伸超过导管1112的远端1126，并且叶轮1116的近侧部分向近侧延伸超过导管1112的近端1128。在该图中，每个叶轮的部分在该展开配置中轴向地位于导管内。
在图2所示的示例性实施例中，叶轮1116和1118与共同的驱动机构1117可操作地连通，并且在该实施例中，叶轮均联接至驱动机构1117，驱动机构1117延伸通过轴1119和工作部分1104。例如，驱动机构1117可以是细长的驱动缆线，该细长驱动缆线在旋转时导致叶轮旋转。在该示例中，如图所示，驱动机构1117延伸到远侧末端1114并相对于远侧末端1114轴向固定，尽管它在被致动时适于相对于远侧末端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。可以使用任何数量的已知机构来旋转驱动机构，比如利用电动机(例如，外部电动机)。
可扩展构件和导管与叶轮和驱动机构没有可旋转操作地连通。在该实施例中，近侧可扩展构件1108的近端1121联接到轴1119，轴1119可以是细长部分1106的轴(例如，外部导液管轴)。近侧可扩展构件1108的远端1122联接到中心管状构件1133，驱动机构1117穿过该中心管状构件延伸。中心管状构件1133从导管1112内的近侧可扩展构件1108向远侧延伸，并且还联接至远侧可扩展构件1110的近端1124。驱动机构1117因此在中心管状构件1133内并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的远端1125联接至远侧末端1114，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适于并配置为折叠成比其展开配置(图2所示)小的外形。与工作部分1104都不是可折叠的情况所需要的相比，这允许使用较小外形的递送装置(较小的法国尺码(French size))进行递送。即使本文未特别说明，任何可扩展构件和叶轮也可以适于和配置为在某种程度上可折叠成较小的递送配置。
可以使用常规技术，例如利用相对于工作部分可动的外部护套(例如，通过使护套和工作部分中的一个或两者轴向地运动)，来将本文的工作部分折叠成折叠的递送配置。例如但不限于，以下参考文献中所示的任何系统、装置或方法都可以用来促进本文的工作部分的折叠：美国专利No.7,841,976或美国专利No.8,052,749，其公开内容出于所有目的通过引用合并于此。
图3A-图3D示出在某种程度上与图2中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类似之处在于包括当工作部分扩展时彼此轴向间隔开的两个可扩展构件以及在两个可扩展构件之间延伸的导管。图3A是透视图，图3B是侧面剖视图，图3C和图3D是图3B中的视图的截面的特写侧面剖视图。
工作部分340包括近侧叶轮341和远侧叶轮342，其联接至驱动缆线并且与驱动缆线可操作地连通，驱动缆线中限定了内腔。内腔的尺寸可以设置成容纳导丝，导丝可以用于将工作部分递送至期望位置。在该实施例中，驱动缆线包括第一区段362(例如，缠绕材料)、联接近侧叶轮341的第二区段348(例如，管状构件)、第三区段360(例如，缠绕材料)、和联接远侧叶轮342的第四区段365(例如，管状材料)。驱动缆线区段均具有相同的内径，使得内腔具有恒定的内径。可以使用已知的附接技术将驱动缆线区段彼此固定。第四区段365的远端延伸到工作部分的远侧区域，从而允许工作部分例如在用于定位工作部分的导丝上前进。在该实施例中，第二区段和第四区段可以比第一区段和第三区段硬。例如，第二区段和第四区段可以是管状的，而第一区段和第三区段可以是缠绕材料，以赋予较小的刚度。
工作部分340包括近侧可扩展构件343和远侧可扩展构件344，它们中的每一个都径向地延伸到叶轮之一的外部。可扩展构件具有远端和近端，其也轴向地延伸超过叶轮的远端和近端，这在图3B-图3D中可看出。联接到这两个可扩展构件的是导管356，其具有近端353和远端352。两个可扩展构件均包括多个近侧支柱和多个远侧支柱。近侧可扩展构件343中的近侧支柱延伸至并固定至轴区段345，轴区段345联接至轴承361，驱动缆线穿过轴承361延伸，并且被配置为且尺寸被设置为能旋转。近侧可扩展构件343的远侧支柱延伸至并固定至中心管状构件346的近侧区域(在该情况下固定至近端)，该中心管状构件轴向地设置在可扩展构件之间。中心管状构件346的近端联接至轴承349，如图3C所示，驱动缆线穿过轴承349延伸并旋转。远侧可扩展构件344的近侧支柱延伸至并固定至中心管状构件346的远侧区域(在该情况下固定至远端)。轴承350也联接至中心管状构件346的远侧区域，如图3D所示。驱动缆线延伸穿过轴承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并固定至轴区段347(见图3A)，该轴区段可被视为远侧末端的一部分。轴区段347联接至轴承351(见图3D)，驱动缆线穿过轴承351延伸并相对于其旋转。远侧末端还包括轴承366(见图3D)，轴承366可以是推力轴承。工作部分340在某些方面与工作部分1104相似或相同，即使在说明中未明确包括。在该实施例中，导管356与工作部分1104不同，至少延伸到叶轮的末端那么远。可以对两个实施例中的任一个进行修改，使得导管延伸到另一个实施例中所述的位置。在一些实施例中，区段360可以是管状区段，而不是缠绕的。
在替代实施例中，本文的任何叶轮的至少一部分可以延伸到流体腔的外部。例如，仅叶轮的一部分可以在近侧或远侧方向上延伸超过流体腔的端部。在一些实施例中，在流体腔的外部延伸的叶轮的一部分是叶轮的近侧部分，并且包括近端(例如，参见图2中的近侧叶轮)。在一些实施例中，叶轮的在流体腔外部延伸的该部分为叶轮的远侧部分，并包括远端(例如，参见图2中的远侧叶轮)。当本发明在本文中提及在流体腔外部延伸(或超过端部)的叶轮时，意思是指部件的相对轴向位置，其可以在侧视图或顶视图中(比如，在图2中)最容易看到。
但是，位于流体腔的另一端的第二叶轮可以不延伸超过流体腔。例如，示例性替代设计可以包括向近侧延伸超过流体腔的近端的近侧叶轮(如图2中的近侧叶轮)，并且流体腔不向远侧延伸超过远侧叶轮的远端(如图3B)。替代地，远侧叶轮的远端可以向远侧延伸超过流体腔的远端，但是近侧叶轮的近端不向近侧延伸超过流体腔的近端。在本文的任何泵部分中，可以没有叶轮延伸超过流体腔的端部。
尽管本文可能示出了特定的示例性位置，但是流体泵可以能够在体内的各种位置中使用。用于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，比如横跨瓣膜并位于瓣膜的一侧或两侧，在主动脉瓣的情况下，可选地包括位于升主动脉中的部分。例如，在一些其他实施例中，泵在使用中可以位于更下游，比如布置在降主动脉中。
图4示出来自图2的系统1000的工作部分1104的示例性放置。图4所示的区别在于，导管至少延伸至叶轮的端部，如图3A-图3D中那样。图4示出了处于展开配置的工作部分1104，其跨越主动脉瓣定位到位。工作部分1104可以如图所示经由例如但不限于股动脉穿刺(已知的穿刺手术过程)来递送。尽管为了清楚而未示出，但是系统1000还可以包括外部护套或轴，在递送至主动脉瓣附近的位置期间，工作部分1104被布置在外部护套或轴中。护套或轴可以向近侧运动(朝向升主动脉“AA”并且远离左心室“LV”)以允许工作部分1104展开和扩展。例如，可以撤回护套以允许第二可扩展构件1110扩展，其中连续的近侧运动允许第一可扩展构件1108扩展。
在该实施例中，第二可扩展构件1110已经被扩展并且以展开配置定位以使得远端1125在左心室“LV”中，并且在主动脉瓣小叶“VL”的远侧，并在瓣环的远侧。近端1124也已经定位在小叶VL的远侧，但是在一些方法中，近端1124可以在小叶VL内稍微轴向延伸。该实施例是其中第二可扩展构件1110的至少一半在沿其长度测量(沿纵向轴线测量)时在左心室内的一种方法的示例。并且如图所示，这也是其中整个第二可扩展构件1110位于左心室内的一种方法的示例。这也是其中第二叶轮1118的至少一半定位在左心室内的一种方法的示例，也是其中整个第二叶轮1118定位在左心室内的一个实施例。
外轴或护套的继续收回(和/或工作端1104相对于外护套或轴的远侧运动)继续释放导管1112，直到中心区域1113被释放并展开。如图4所示，可扩展构件1108和1110的扩展使导管1112采取更开放的配置。因此，尽管在该实施例中，导管1112不具有与可扩展构件相同的自扩展特性，但是导管在工作端被展开时将采取展开的、更开放的配置。导管1112的中心区域1113的至少一部分定位在主动脉瓣接合区域。在图3中，存在向远侧延伸超过小叶VL的一小段中心区域1113，但中心区域1113的至少某部分轴向地在小叶内。
外部轴或护套的连续收回(和/或工作端1104相对于外部护套或轴的远侧运动)展开第一可扩展构件1108。在该实施例中，第一可扩展构件1108已被扩展并定位在(如图所示)展开配置下，使得近端1121处于升主动脉AA中，并且在小叶“VL”近侧。远端1122也已经定位在小叶VL近侧，但在一些方法中，远端1122可以在小叶VL内稍微轴向延伸。该实施例是其中第一可扩展构件1110的至少一半在沿其长度测量(沿纵向轴线测量)时处于升主动脉内的一种方法的示例。并且如图所示，这也是其中整个第一可扩展构件1110在AA内的一种方法的示例。这也是其中第一叶轮1116的至少一半位于AA内的一种方法的示例，并且也是整个第一叶轮1116定位在AA内的一个实施例。
在工作部分1104展开期间或之后的任何时间，可以以任何方式(比如，在荧光透视下)评估工作部分的位置。可以在展开期间或展开后的任何时间调整工作部分的位置。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，工作部分1104可以轴向地(向远侧或向近侧)运动以重新定位工作部分。另外，例如，可以在整个工作部分已经从护套释放到期望的最终位置之后重新定位工作部分。
应当理解，即使在初始展开之后发生重新定位，图4中所示的部件(相对于解剖结构)的位置也被认为是工作部分1104的不同部件的示例性最终位置。
本文的一个或多个可扩展构件可以被配置成并且可以以多种方式被扩展，比如，经由自扩展、机械致动(例如，在可扩展构件上的一个或多个轴向力，利用单独的球囊来扩展，该球囊径向地被定位在可扩展构件内并被充气以在可扩展构件上径向地向外推动)、或其组合而被扩展。
本文所使用的扩展通常是指重新配置成具有较大的径向最外尺寸(相对于纵向轴线)的较大外形，而不管其中一个或多个部件扩展的具体方式如何。例如，自扩展的和/或受到径向向外的力的支架可以如本文中所使用的术语那样“扩展”。被打开或铺开的装置也可以采取较大的外形，并且可以被认为如本文中所使用的术语那样扩展。
叶轮可以类似地适于和配置为、并可以根据其构造以多种方式进行扩展。例如，一个或多个叶轮一旦从护套释放后可以由于叶轮设计的材料和/或构造而自动回复或转向不同的较大的外形配置(例如，参见美国专利No.6,533,716或美国专利No.7,393,181，两者出于所有目的通过引用并入于此)。因此，在一些实施例中，外部约束的收回可以允许可扩展构件和叶轮两者自然地回复到较大外形的展开配置，而无需任何进一步的致动。
如图4中的示例所示，工作部分包括第一和第二叶轮，它们在主动脉瓣的两侧间隔开，每个叶轮布置在单独的可扩展构件中。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。工作端1104包括在可扩展构件1108与1110之间延伸的导管1112，而不是跨越瓣膜一直延伸的单个通常管状的可扩展构件。导管比可扩展的篓更柔性和可变形，这与可扩展构件横跨主动脉瓣小叶相比可以允许小叶位置处的工作部分的更大变形。在工作部分已被部署在受试者中之后，这可以对小叶造成更小的损伤。
另外，来自小叶的单个可扩展构件的中心区域上的力可能轴向地转移到可扩展构件的其他区域，可能在一个或多个叶轮的位置处引起可扩展构件的不期望变形。这可能导致外部可扩展构件接触叶轮，从而不期望地干扰了叶轮的旋转。在每个叶轮周围包括单独的可扩展构件的设计，尤其是在每个可扩展构件和每个叶轮的两端(即，远端和近端)都受到支撑的情况下，会使得叶轮相对于可扩展构件的定位具有很高的精度。与单个可扩展构件相比，两个单独的可扩展构件可以能够更可靠地保持其展开配置。
如上所述，可能希望能够重新配置工作部分，以使其可以在9F护套内递送并在使用时仍获得足够高的流量，这对于当前正在开发和/或测试的某些产品是不可能的。例如，某些产品太大而无法重新配置为足够小的递送外形，而一些较小的设计可能无法实现期望的高流速。图1、图2、图3A-图3D和图4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期望流速，并且通过具有两个轴向间隔开的叶轮，整个工作部分可以被重新配置为比其中使用单个叶轮实现期望流速的设计小的递送外形。因此，这些实施例使用多个较小的、可重新配置的轴向间隔开的叶轮，以同时实现期望的较小递送外形以及期望的高流速。
因此，本文的实施例可以在保持足够高的流速的同时实现较小的递送外形，同时产生工作部分的可更大变形和更柔性的中心区域，其示例性优点如上所述(例如，与精致的瓣膜小叶相接)。
图5示出了与图1所示的工作部分类似的工作部分。工作部分265包括近侧叶轮266、远侧叶轮267，两者均联接至延伸到远侧轴承壳体272中的驱动轴278。在工作部分的近端处有类似的近侧轴承壳体。工作部分还包括可扩展构件(通常称为270)、以及被固定至可扩展构件并延伸了可扩展构件的几乎整个长度的导管268。可扩展构件270包括远侧支柱271，其延伸至并固定至支柱支撑件273(其固定至远侧末端273)。可扩展构件270还包括固定至近侧支柱支撑件的近侧支柱。即使没有明确说明，与图l所示类似的所有特征也出于所有目的以引用方式并入本实施例中。可扩展构件265还包括螺旋拉伸构件269，其沿可扩展构件的外围布置，并在可扩展构件如图所示处于扩展配置时具有螺旋构造。螺旋拉伸构件269被布置为并适于在折叠时引起旋转包裹。工作部分265可以从所示的扩展配置折叠，同时以相对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导致的卷曲折叠。螺旋拉伸构件269(或可扩展构件单元的螺旋布置)将充当集合拉伸构件，并被配置为使得当可扩展篓沿其长度拉伸以折叠时(比如，通过拉伸到大得多的长度，如大约两倍的长度)，拉伸构件269被拉成更直的对齐方式，这导致在折叠期间可扩展构件的期望节段旋转/扭曲，从而导致叶轮叶片随着可扩展构件和叶片折叠而径向地向内包裹。当处于近似等于折叠时可扩展构件的最大长度的螺旋形式时，这种拉伸构件的示例性配置将具有曲线配置。在替代实施例中，仅使可扩展构件的包围可折叠叶轮的部分在折叠时旋转。
存在替代的方式来构造工作部分，以在通过拉长而折叠时引起可扩展构件的旋转(并因此引起叶轮叶片的包裹和折叠)。即使在双叶轮设计中，任何可扩展构件均可以通过该特征来构造。例如，对于包括多个“单元”(该术语通常为已知)的可扩展构件(例如，激光切割细长构件)，可扩展构件可以具有多个特定单元，它们一起限定诸如螺旋配置之类的特定配置，其中限定该配置的单元与可扩展构件中的其他单元具有不同的物理特征。在一些实施例中，可扩展构件可以具有编织构造，并且扭曲区域可以构成编织线的整个线材组或者构成编织线的重要部分(例如一半以上)。这样的扭曲编织构造可以例如在编织过程期间比如通过以下方式来实现：当其上编织了线材的芯轴被拉拽时，尤其是沿着编织结构的最大直径部分的长度拉拽时，对该芯轴进行扭曲。还可以在该构造过程的第二操作期间，比如在将缠绕外形热定型在成型芯轴上之前将编织结构机械扭曲，来实现该构造。
本文的任何导管用来、被构造为、且由在第一端(例如，远端)与第二端(例如，近端)之间在其中产生流体腔的材料制成。流体流进入流区域，通过流体腔，然后从出流区域流出。进入入流区域的流动在本文可以标记为“I”，而从出流区域流出的流动可以标记为“O”。本文的任何导管可以是不可渗透的。可替代地，本文的任何导管可以是半渗透的。本文的任何导管也可以是多孔的，但仍将限定穿过其中的流体腔。在一些实施例中，导管是膜或其他相对薄的层状构件。除非有相反的指示，否则本文的任何导管均可以固定到可扩展构件上，使得固定在其上的导管可以在可扩展构件的径向内部和/或外部。例如，导管可以在可扩展构件内径向地延伸，使得导管的内表面在其被固定到可扩展构件之处径向地在可扩展构件内。
本文的任何可扩展构件均可以由多种材料和多种方式来构造。例如，可扩展构件可以具有编织构造，或者可以通过激光加工形成。该材料可以是可变形的，比如镍钛诺。可扩展构件可以是自扩展的，或者可以适于至少部分地主动扩展。
在一些实施例中，可扩展构件适于在从诸如递送导液管、引导导液管或管路护套的容纳管状构件内释放时自扩展。在一些替代实施例中，可扩展构件适于通过主动扩展来扩展，比如，使可扩展构件的远端和近端中的至少之一朝彼此运动的拉杆动作。在替代实施例中，展开配置会受到一个或多个可扩展结构的配置的影响。在一些实施例中，一个或多个可扩展构件可以通过流过导管的血液的影响而至少部分地展开。可以使用以上扩展机制的任何组合。
本文的血泵和流体运动装置、系统和方法可以在体内的各种位置使用和定位。尽管本文可能提供了具体示例，但是应理解，工作部分可以定位在与本文具体描述的那些不同的身体区域中。
在其中医疗装置包括多个叶轮的本文的任何实施例中，该装置可以适于使得叶轮以不同的速度旋转。图6A示出了包括与内部驱动构件1338和外部驱动构件1336两者均联接的齿轮组1340的医疗装置，内部驱动构件1338和外部驱动构件1336分别与远侧叶轮1334和近侧叶轮1332可操作地连通。该装置还包括电动机1342，其驱动内部驱动构件1338的旋转。内部驱动构件1338延伸穿过外部驱动构件1336。电动机1332的激活会由于减速传动比或超速传动比而使得两个叶轮以不同的速度旋转。齿轮组1340可以适于驱动近侧或远侧叶轮中的任一个比另一个快。本文的任何装置可以包括本文的任何齿轮组，以不同的速度驱动叶轮。
图6B示出了双叶轮装置(1350)的替代实施例的一部分，该双叶轮装置也适于使得不同的叶轮以不同的速度旋转。齿轮组1356联接至分别与远侧叶轮1352和近侧叶轮1354联接的内部驱动构件1351和外部驱动构件1353两者。该装置还包括如图6A所示的电动机。图6A和图6B示出了齿轮组如何可以适于比远侧叶轮慢或快地驱动近侧叶轮。
图7示出了可以以不同的速度旋转第一叶轮和第二叶轮的流体泵1370的示例性替代实施例。第一电动机1382驱动联接至远侧叶轮1372的缆线1376，而第二电动机1384(经由齿轮组1380)驱动联接至近侧叶轮1374的外驱动构件1378。驱动缆线1376延伸穿过外驱动构件1378。各电动机可以被单独控制和操作，因此两个叶轮的速度可以分别控制。该系统设置可以与本文的包括多个叶轮的任何系统一起使用。
在一些实施例中，共同的驱动缆线或轴可以驱动两个(或多个)叶轮的旋转，但是两个叶轮的叶片节距(旋转曲率角)可以不同，其中远侧或近侧叶轮可以具有比其他叶轮陡或平缓的角度。这可以产生与具有齿轮组相似的效果。图6C示出了医疗装置(1360)的一部分，其包括联接至近侧叶轮1364和远侧叶轮1362以及未示出的电动机的共同的驱动缆线1366。本文的近侧叶轮可以具有比本文的远侧叶轮大或小的节距。本文的具有多个叶轮的任何工作部分(或远侧部分)可以被修改为包括具有不同节距的第一叶轮和第二叶轮。
在本文的任何实施例中，泵部分可具有顺应或半顺应(通常一起称为“顺应”)的外部结构。在各种实施例中，顺应部分是柔韧的。在各种实施例中，顺应部分在压力下仅部分变形。例如，泵的中心部分可以由外部顺应结构形成，使得其响应于瓣膜的力而变形。以这种方式，减小了泵在瓣膜小叶上的外力。这可以帮助防止在跨越瓣膜的位置处损伤瓣膜。
图8示出了泵部分的示例性实施例，该泵部分包括第一、第二和第三轴向间隔开的叶轮152，每个叶轮设置在可扩展构件154内。导管155可以沿着泵部分的长度延伸，如在本文各个实施例中所述，这可以帮助产生和限定流体腔。然而，在替代实施例中，第一、第二和第三叶轮可以设置在单个可扩展构件内，类似于图1所示。在图8中，流体腔从远端延伸到近端，其特征在本文其他地方描述。图8中的实施例可以包括本文所述的任何其他合适的特征，包括使用方法。
图8中的实施例也是壳体的示例，该壳体在近侧叶轮远端和远侧叶轮近端之间形成有至少一个弯曲部，使得该壳体的在弯曲部远侧的远侧区域与该壳体的在弯曲部近侧的近侧区域沿着轴线不轴向对准。在该实施例中，在壳体中形成有两个弯曲部150和151，每个弯曲部在两个相邻的叶轮之间。
在一种使用方法中，可以将形成在壳体中的弯曲部定位成横跨瓣膜，比如图8所示的主动脉瓣。在该放置方法中，中心叶轮和最远侧叶轮位于左心室中，并且最近侧叶轮位于升主动脉中。弯曲部151恰位于主动脉瓣的下游。
诸如弯曲部151或152的弯曲部可以并入本文的任何实施例或设计中。弯曲部可以是预成型的角度，也可以是现场可调的。
在本文的任何实施例中，除非有相反的指示，否则壳体沿着其长度可以具有基本上均匀的直径。
在图8中，泵经由腋动脉定位，这是一种穿刺主动脉瓣的示例性方法，其允许患者行走和活动时中断更少。本文的任何设备均可以经由腋动脉定位。然而，从本文的描述中人们将认识到，可以以各种方式将泵引入并跟踪到位，包括主动脉弓上方的股动脉入路。
本发明的一个方面是一种血管内血泵，其包括与近侧叶轮轴向间隔开的远侧叶轮。在一个实施例中，远侧叶轮和近侧叶轮彼此分离。例如，远侧叶轮和近侧叶轮可以仅通过它们各自的附接连接到共同的驱动轴。这不同于具有多个叶片排的叶轮。本文使用的远侧叶轮这个短语不一定表示泵的最远侧叶轮，而是可以一般地指比近侧叶轮更靠远侧定位的叶轮，即使存在比该远侧叶轮更靠远侧布置的其他叶轮。类似地，本文使用的近侧叶轮这个短语不一定表示泵的最近侧叶轮，而是可以一般地指比近侧叶轮更靠近侧定位的叶轮，即使存在比该近侧叶轮更靠近侧布置的其他叶轮。轴向间距(或其一些派生词)是指沿泵部分的长度(比如，沿泵部分的纵向轴线)的间距，即使在泵部分中存在弯曲部也是如此。在各个实施例中，近侧叶轮和远侧叶轮中的每一个均定位在各自的壳体内，并被配置为维持精确、一致的末端间隙，并且叶轮之间的跨度具有相对更柔性(或完全柔性)的流体腔。例如，每个叶轮可以定位在具有相对刚性的外壁的各个壳体内以抵抗径向折叠。叶轮之间的区段可以是相对刚性的，在一些实施例中，所述区段主要通过内部流体压力保持打开。
尽管本文的实施例没有要求，但是在近侧叶轮与远侧叶轮之间具有最小轴向间隔会是有利的。例如，泵部分可以通过解剖结构中具有相对紧的弯曲部(比如，例如主动脉)的部分被递送至目标位置，并向下进入主动脉瓣。例如，泵部分可以被递送通过股动脉穿刺，达至主动脉瓣。具有更容易弯曲的系统以使得更易于将系统递送通过解剖结构中的弯曲部，这可能是有利的。其中多个叶轮彼此非常接近的一些设计可能会使系统在横跨多个叶轮的长度上沿着横跨这多个叶轮的整个长度而相对较硬。将叶轮轴向间隔开并在叶轮之间选择性地提供相对柔性的区域，可以使系统的一部分更柔性、更容易弯曲、并且可以更轻松且更安全地通过弯曲部行进。另一示例性优点是，轴向间距可允许叶轮之间的相对更顺应的区域，该区域可定位在例如瓣膜(例如，主动脉瓣)的位置处。此外，本文的各个实施例与典型的多级泵之间还存在其他潜在的优势和功能差异。典型的多级泵包括具有很近的功能性间隔的成排的叶片(有时称为叶轮)，使得成排的叶片一起充当同步级。人们将意识到，当流动通过远侧叶轮时可以分流。在本文所述的各个实施例中，远侧叶轮和近侧叶轮可以充分地间隔开，以使得从远侧叶轮分离的流动大幅减小(即，增大的流动重附接)，并且在流动进入近侧叶轮之前耗散了局部湍流。
在本文的包括远侧叶轮和近侧叶轮的任何实施例或说明书的任何部分中，近侧叶轮的远端与远侧叶轮的近端之间的轴向间隔可以为沿着泵部分的纵向轴线或沿着包括流体腔的壳体部分的纵向轴线从1.5cm至25cm(包括端点)。当泵部分(包括任何叶轮)处于扩展配置时，可以测量该距离。当泵部分被递送通过解剖结构的弯曲部分(比如，例如经由主动脉通过主动脉瓣)时，该示例性范围可以提供本文所述的示例性的柔性益处。图9(以展开配置在患者体外示出)示出了长度Lc，其示出了叶轮之间的轴向间隔，并且在一些实施例中可以如本文所述从1.5cm至25cm。在可能存在多于两个叶轮的实施例中，任何两个相邻的叶轮(即，在它们之间没有任何其他旋转叶轮的叶轮)可以轴向间隔开本文所述的任何轴向间隔距离。
尽管一些实施例包括沿轴线与远侧叶轮近端轴向间隔开从1.5cm至25cm的近侧叶轮远端，但是本发明在本文中还包括在从1.5cm至25cm的一般范围内的子范围的任何轴向间隔。也就是说，本发明包括具有在该范围内从1.5及以上的任何下限的所有范围，以及具有从25cm及以下的任何上限的所有子范围。以下示例提供了示例性子范围。在一些实施例中，近侧叶轮远端沿轴线与远侧叶轮近端轴向间隔开从1.5cm至20cm、从1.5cm至15cm、从1.5cm至10cm、从1.5cm至7.5cm、从1.5cm至6cm、从1.5cm至4.5cm、从1.5cm至3cm。在一些实施例中，轴向间距是从2cm至20cm、从2cm至15cm、从2cm至12cm、从2cm至10cm、从2cm至7.5cm、从2cm至6cm、从2cm至4.5cm、从2cm至3cm。在一些实施例中，轴向间隔是从2.5cm至15cm、从2.5cm至12.5cm、从2.5cm至10cm、从2.5cm至7.5cm、或从2.5cm至5cm(例如3cm)。在一些实施例中，轴向间隔是从3cm至20cm、从3cm至15cm、从3cm至10cm、从3cm至7.5cm、从3cm至6cm、或从3cm至4.5cm。在一些实施例中，轴向间隔是从4cm至20cm、从4cm至15cm、从4cm至10cm、从4cm至7.5cm、从4cm至6cm、或从4cm至4.5cm。在一些实施例中，轴向间隔是从5cm至20cm、从5cm至15cm、从5cm至10cm、从5cm至7.5cm、或从5cm至6cm。在一些实施例中，轴向间隔是从6cm至20cm、从6cm至15cm、从6cm至10cm、或从6cm至7.5cm。在一些实施例中，轴向间隔是从7cm至20cm、从7cm至15cm、或从7cm至10cm。在一些实施例中，轴向间隔是从8cm至20cm、从8cm至15cm、或从8cm至10cm。在一些实施例中，轴向间隔是从9cm至20cm、从9cm至15cm、或从9cm至10cm。在各个实施例中，叶轮之间的流体腔是相对不受支撑的。
在本文的任何实施例中，一个或多个叶轮的长度可以具有在叶轮远端与叶轮近端之间轴向测量的长度(在图9中分别示为“LSD”和“LSP”)，从.5cm至10cm或其任何子范围。以下示例提供了示例性子范围。在一些实施例中，叶轮轴向长度是从.5cm至7.5cm、从.5cm至5cm、从.5cm至4cm、从.5cm至3cm、从.5cm至2cm、或者从.5cm至1.5cm。在一些实施例中，叶轮轴向长度是从.8cm至7.5cm、从.8cm至5cm、从.8cm至4cm、从.8cm至3cm、从.8cm至2cm、或者从.8cm至1.5cm。在一些实施例中，叶轮轴向长度是从1cm至7.5cm、从1cm至5cm、从1cm至4cm、从1cm至3cm、从1cm至2cm、或从1cm至1.5cm。在一些实施例中，叶轮轴向长度为从1.2cm至7.5cm、从1.2cm至5cm、从1.2cm至4cm、从1.2cm至3cm、从1.2至2cm、或从1.2cm至1.5cm。在一些实施例中，叶轮轴向长度是从1.5cm至7.5cm、从1.5cm至5cm、从1.5cm至4cm、从1.5cm至3cm、或从1.5cm至2cm。在一些实施例中，叶轮轴向长度是从2cm至7.5cm、从2cm至5cm、从2cm至4cm、或从2cm至3cm。在一些实施例中，叶轮轴向长度为从3cm至7.5cm、从3cm至5cm、或从3cm至4cm。在一些实施例中，叶轮轴向长度为从4cm至7.5cm、或从4cm至5cm。
在本文的任何实施例中，流体腔可以具有从远端至近端的长度，如图9中的长度Lp所示。在一些实施例中，流体腔长度Lp为从4cm至40cm，或其中的任何子范围。例如，在一些实施例中，长度Lp可以是从4cm至30cm、从4cm至20cm、从4cm至18cm、从4cm至16cm、从4cm至14cm、从4cm至12cm、从4cm至10cm、从4cm至8cm、从4cm至6cm。
在本文的任何实施例中，壳体可以至少在叶轮的位置(并且可选地在叶轮之间的位置)具有展开的直径，如图9中的尺寸Dp所示。在一些实施例中，Dp可以为从.3cm至1.5cm，或其中的任何子范围。例如，Dp可以从.4cm至1.4cm、从.4cm至1.2cm、从.4cm至1.0cm、从.4cm至.8cm、或从.4cm至.6cm。在一些实施例中，Dp可以是从.5cm至1.4cm、从.5cm至1.2cm、从.5cm至1.0cm、从.5cm至.8cm、或从.5cm至.6cm。在一些实施例中，实施例Dp可以从.6cm至1.4cm、从.6cm至1.2cm、从.6cm至1.0cm、或从.6cm至.8cm。在一些实施例中，Dp可以从.7cm至1.4cm、从.7cm至1.2cm、从.7cm至1.0cm、或从.7cm至.8cm。
在本文的任何实施例中，叶轮可以具有展开的直径，如图9中的尺寸Di所示。在一些实施例中，Di可以为从1mm-30mm，或其中的任何子范围。例如，在一些实施例中，Di可以为从1mm-15mm、从2mm-12mm、从2.5mm-10mm、或从3mm-8mm。
在本文的任何实施例中，在叶轮外径与流体腔内径之间存在末端间隙。在一些实施例中，末端间隙可以是从0.01mm-1mm，比如从.05mm至.8mm，或比如0.1mm-0.5mm。
在本文的任何实施例中，一个或多个流动扩散器和一个或多个定子中的至少一个沿着导液管轴位于两个或更多个叶轮之间。这种流动扩散器可以帮助减少流体的涡流并且总体上提高作为一组的多个叶轮的效率。
在本文的任何实施例中，可扩展护罩篓或可扩展构件的流体出口处的特征被成形为充当流体扩散器，比如在导液管轴外部尺寸与可扩展构件外部尺寸之间的附接处的支架状支柱，其可以是叶片状的，具有引导来改变血液流向的扭曲部。在本文的任何实施例中，叶轮下游的导液管轴的一个或多个部分可以扩张到更大的直径以改变血流角度并导致血流减速至更接近天然主动脉血流的速度。叶轮下游的较大直径的示例性位置可以是在可扩展护罩篓附接至导液管轴的区域处或附近，和/或邻近叶轮的轴承壳体处，或在内部电动机上或附近。

Claims (7)

1.一种血管内血泵，包括：
包括流体腔的可折叠壳体，所述流体腔具有远端和近端；和
与可折叠近侧叶轮轴向间隔开的可折叠远侧叶轮，所述远侧叶轮和所述近侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间，
其中所述远侧叶轮具有在扩展状态下的扩展配置，所述近侧叶轮具有在扩展状态下的扩展配置，
其中所述远侧叶轮的所述扩展配置与所述近侧叶轮的所述扩展配置不同，以及
其中所述近侧叶轮和所述远侧叶轮由共同的驱动机构激活，所述共同的驱动机构延伸通过导液管、通过所述近侧叶轮、在所述近侧叶轮与所述远侧叶轮之间、通过所述远侧叶轮，并且联接到所述远侧叶轮和所述近侧叶轮且从所述远侧叶轮和所述近侧叶轮朝向电动机向近侧延伸，并且其中所述共同的驱动机构的在所述近侧叶轮与所述远侧叶轮之间的区域比所述共同的驱动机构延伸通过所述近侧叶轮处更柔性且比所述共同的驱动机构延伸通过所述远侧叶轮处更柔性。
2.根据权利要求1所述的血泵，其中，所述可折叠远侧叶轮具有远侧叶片，所述近侧叶轮具有近侧叶片，其中所述远侧叶片具有与所述近侧叶片不同的节距。
3.根据权利要求2所述的血泵，其中，所述远侧叶片是多个远侧叶片中的一个，并且其中所述近侧叶片是多个近侧叶片中的一个，其中所述多个远侧叶片具有与所述多个近侧叶片中的每一个均不同的节距。
4.根据权利要求2所述的血泵，其中，所述近侧叶轮被成形、确定尺寸和定位为主要提供离心流，所述远侧叶轮被成形和确定尺寸为主要提供轴向流。
5.根据权利要求1所述的血泵，其中，远侧叶轮和近侧叶轮适于且被配置为使流体在相同方向上运动。
6.一种血管内血泵，包括：
包括流体腔的可折叠壳体，所述流体腔具有远端和近端；
与可折叠近侧叶轮轴向间隔开的可折叠远侧叶轮，所述远侧叶轮的至少一部分被轴向布置在所述流体腔的所述远端与所述近端之间，
其中所述近侧叶轮的近端在所述可折叠壳体处于扩展配置时且在所述可折叠近侧叶轮处于扩展配置时被布置在所述流体腔的所述近端的近侧，
其中所述近侧叶轮和所述远侧叶轮由共同的驱动机构激活，所述共同的驱动机构延伸通过导液管、通过所述近侧叶轮、在所述近侧叶轮与所述远侧叶轮之间、通过所述远侧叶轮，并且联接到所述远侧叶轮和所述近侧叶轮且从所述远侧叶轮和所述近侧叶轮朝向电动机向近侧延伸，并且其中所述共同的驱动机构的在所述近侧叶轮与所述远侧叶轮之间的区域比所述共同的驱动机构延伸通过所述近侧叶轮处更柔性且比所述共同的驱动机构延伸通过所述远侧叶轮处更柔性。
7.根据权利要求6所述的血泵，其中，所述远侧叶轮的远端在所述可折叠壳体处于扩展配置时且在所述可折叠远侧叶轮处于扩展配置时被布置得不比所述流体腔的所述远端更远。
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