CN105363081B - 免清洗的小型旋转式泵 - Google Patents

免清洗的小型旋转式泵 Download PDF

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CN105363081B
CN105363081B CN201510802088.3A CN201510802088A CN105363081B CN 105363081 B CN105363081 B CN 105363081B CN 201510802088 A CN201510802088 A CN 201510802088A CN 105363081 B CN105363081 B CN 105363081B
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blood pump
driver element
impeller
flow passage
rotor
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CN105363081A (zh
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T.西斯
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Abiomed Inc
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
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    • F04D13/02—Units comprising pumps and their driving means
    • F04D13/06—Units comprising pumps and their driving means the pump being electrically driven
    • 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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    • 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
    • A61M60/13—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 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
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    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
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    • A61M60/416—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 directly by the motor rotor drive shaft
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A61M60/816—Sensors arranged on or in the housing, e.g. ultrasound flow sensors
    • 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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    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
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    • A61M60/822—Magnetic bearings specially adapted for being actively controlled
    • 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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    • A61M60/818—Bearings
    • A61M60/825—Contact bearings, e.g. ball-and-cup or pivot bearings
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/04—Shafts or bearings, or assemblies thereof
    • F04D29/046—Bearings
    • F04D29/048—Bearings magnetic; electromagnetic
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/18—Rotors
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
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    • F04D29/40—Casings; Connections of working fluid
    • F04D29/406—Casings; Connections of working fluid especially adapted for liquid pumps
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    • 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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    • A61M60/10—Location thereof with respect to the patient's body
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
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Abstract

本发明涉及使用免清洗的小型泵来循环血液的方法和系统。在一个实施例中，提供的泵(100)包括具有位于驱动单元(210)内的转子(400)和定子(300)的壳体(200)。在该实施例中，泵(100)可建立通过驱动单元(210)和壳体(200)之间的空间的主要血流(240)和位于转子(400)及定子(300)之间的次要血流(255)。在另一个实施例中，提供一种方法来将泵(100)导入体内并且使用泵(100)循环血液。

Description

免清洗的小型旋转式泵
本申请是申请号200880114288.8、申请日2008年10月27日、发明名称“免清洗的小型旋转式泵”的中国发明专利申请的分案申请。
背景技术
本发明的实施例总体涉及，但不限于，提供和使用医疗设备，并且更具体地涉及提供和使用小型的、可植入式的血泵以协助或补充心脏功能。
发明内容
本发明的至少一些方面和实施例涉及用于协助人心脏功能的系统和方法。特别地，一个实施例涉及使用具有管状壳体的小型血泵来泵血的系统和方法，所述壳体包括支撑叶轮的驱动单元，其中该驱动单元无需使用清洗液而保持不具有血块或其他血液沉淀物。
现有的小型血泵，诸如美国专利No.6,942,611，采用清洗液以保持电机组没有会损害性能或长期导致泵卡死的障碍物。尽管清洗液的配置比较有效，当其长期使用时，例如超过30天时，其所需的附加结构可能增加泵失灵的风险。
根据本发明的一个实施例包括血泵，其可包括其中定位电动驱动单元的管状壳体。该驱动单元可同轴布置在壳体中，在驱动单元和壳体的内表面之间的环形空间形成主要的血流通道。在这种构造中，血液被布置在驱动单元上游侧的叶轮通常以螺旋运动驱动，沿着流动通道流通并且从横向分支的出口管排出壳体。
壳体和出口管可具有L形构造，籍此泵可插入到形成在心脏壁的端口中，而出口管可与目标血管连接。在这种构造中，血泵可起到暂时支撑心脏的作用而不像较大的心内血泵一样完全插入到心脏内。
本发明的一个方面涉及无需使用清洗液而保持不具有血块或其他血液沉淀物或堆积物的小型血泵。该血泵可包括环形的、构造在转子和定子之间的次要流动通道，血流通过该通道持续冲洗转子和定子的相对移动部分之间的区域。该次要血流可大致与主要血流反向。
本发明的另一方面涉及小型轴向血泵，其中承载叶轮的转子不需要在轴向方向上的支撑。该血泵可应用在轴向方向上支撑转子和叶轮的磁轴承。在一些实施例中，该轴向磁轴承可以至少部分是有源的。
本发明的另一个方面提供了基于导管的泵，其应用清洗液使如上所述布置的次要血流通道畅通。在该装置中，主要血流定向为朝外并且紧接在叶轮后面围绕壳体，并且另一个端口定位在转子后面允许血液流入以形成次要血流。
本发明的另一个方面可提供基于导管的泵，其应用磁轴承以控制承载叶轮的转子的轴向位置。该磁轴承可以是有源的，或无源的或两者均可。
本发明另一个方面涉及通过使用小型血泵来提供心脏辅助的方法，所述血泵包括壳体、定位在壳体内并且具有转子和定子的驱动单元、定位在驱动单元一端并且与转子连接的叶轮，以及从壳体最靠近叶轮的一端延伸的套管。可运行该泵以产生围绕驱动单元的主要血流以及形成在转子和定子之间的环形空间内的次要血流。该次要血流可大致与主要血流反向。可通过机械轴承及/或通过有源或无源磁轴承提供轴向支撑。
附图说明
附图并非想要按比例绘制。在附图中，在不同图中显示的每个相同或几乎相同的组件由相同数字表示。为了清晰的目的，可能不是每个组件在每个图中均被标识。图中：
图1为根据本发明的血泵的一个实施例的横截面示意图；以及图2为根据本发明的基于导管的血泵的一个实施例的横截面示意图；
具体实施方式
现在将参考附图更详细地描述各种实施例和它们的各方面。应当理解本发明的应用并不限于在下面描述中所阐述或附图所示的关于组件构造及布置的细节。本发明能具有其他实施例并且能以各种方式实施或实现。在此提供特定实施方式的范例仅仅为了说明的目的而并非想要进行限制。特别地，针对任何一个或多个实施例所述的动作、元件及特征并非想要在任何其他实施例中排除类似的作用。同样，在此使用的措辞和术语是为了描述的目的并且不应被认作限制。“包括”、“包含”、“具有”、“含”、“包括了”以及它们的变型的使用是为了包围其后所列的项以及它们的等价物和其他项。
图1显示了根据本发明一个实施例的血泵的横截面示意图。
该示意性实施例的血泵100具有细长的、基本圆柱状的壳体200，其中基本同轴地定位驱动单元210。该驱动单元210包括具有定子部分300和转子部分400的电动机。穿过导管230的电导体220对电动机提供电能及控制信号。
在驱动单元210和壳体的内部之间的环形空间形成主要的血流通道240。在一个实施例中，主要血流通道的内径和外径可分别大约为7.0和10.0mm，在主要血流通道中提供大约160mm2的横截面。
定子部分300包括一对永久定子轴承磁体310a、310b。一个定子轴承磁体310a靠近定子的上游端定位，而另一个定子轴承磁体310b靠近下游端固定。
定子轴承磁体310a、310b与永久转子轴承磁体410a、410b配合以形成一对径向磁轴承。该径向轴承允许转子相对于定子转动而没有明显的径向接触并产生环形空间以实现次要血流通道255。该定子轴承磁体310a、310b和转子轴承磁体410a、410b可包括叠层薄盘磁体、具有轴向磁化的管状磁体或任何其他合适的磁体布置。
在所示的实施例中，次要血流通道255的内径和外径可分别大约为3.2和3.8mm，提供大约3.3mm2的横截面。
定子电机磁体320位于定子部分300上的定子轴承磁体310a、310b之间。该定子电机磁体320结合转子电机磁体420以形成可由常规装置驱动以使转子400旋转的电磁电机。
在该实施例中，叶轮500连接在转子400上。叶轮500包括毂510和多个从毂510突出的叶片520。所述叶片可以为任何合适的形状并且可以是任何合适的数目。叶轮500在圆柱状泵环530中旋转，该泵环的直径与叶轮500的包络线的直径大约相同。泵环530的上游端具有包括输入斜面545的轴向入口540。紧跟着泵环530的下游端的为不含叶轮的过渡区域550，其中内侧直径从泵环530到围绕驱动单元210的壳体200的内径连续变大。
转子400的操作产生向前，即在与血流相反的方向上，牵引转子的力。为了防止转子400被向前牵引得太远以至于接触壳体，轴向液压轴承260可定位在包括了叶轮500的转子400的一端。轴向液压轴承260起到阻止转子400向前移动的作用。在该实施例中，轴向液压轴承260提供有多个允许血液通过轴承的开口。在一些实施例中，轴向轴承也可构造为接触球轴承，从而物理地阻止转子400的向前运动，特别在外力施加在装置上的地方或当转子启动或逐渐结束时。
在一些实施例中，可通过定位在转子任一端的轴向磁轴承控制转子400的轴向位置，包括或不包括另外使用机械接触球轴承。例如，在一个实施例中，轴向磁轴承可包括永久轴向壳体磁体270，其定位在壳体200内靠近背离叶轮500的转子400一端，并且与永久轴向转子磁体410配合，其定位在背离叶轮500的转子一端上。在另一个实施例中，轴向轴承可包括有源磁轴承，其单独或与无源磁轴承及/或机械接触球轴承联合操作。在一个实施例中，轴向磁轴承包括设计为抵消当转子400提速时产生的轴向力的圆柱状无源磁体，其由有源磁体围绕，设计为补偿诸如那些在叶轮预负载和后负载期间所出现的那些额外的轴向负载。在一些情况中，可通过测量系统内的反电动势而确定叶轮的轴向位置，因而消除对附加位置传感器的需要。在其他情况中，可应用单独的位置传感器以提供关于转子位置的反馈并便于通过有源磁轴承控制。
出口管600朝流动通道240的下游端从泵壳200横向地分出。该出口管600在基本垂直于流动通道240的方向延伸。在一些实施例中，出口管600的内径可在流动方向上放大。这种放大可为大约5-10度，或者在一个特定实施例中，大约8度。
在特定实施例中，在壳体的内壁中可能具有与主要流动通道240连通的压力探测开口。从所述压力探测开口，压力通道可与延伸通过导管230的软管的内腔连通。压力传感器可连接在导管的近端以探测位于主要流动通道240内的压力探测开口处的压力。作为备选，局部压力传感器可安装在血泵100内。
在一些实施例中，管状套管700可安装在泵环530上并且从壳体200延伸。套管700可具有围绕其外围布置的纵向延伸的槽710，以及/或位于前端的轴向开口720。在一些情况中，套管700的长度可不超过包括泵环530的壳体200的长度。
在所示实施例中，壳体200的外径大约为11mm。壳体在流动通道240区域的内径大约为10mm。驱动单元210具有大约7.0mm的外径。泵环530的内径大约为6mm，套管700的外径大约为10mm，并且套管700的内径大约为8mm。
在该实施例中，包括泵环530的整个壳体200，具有大约50mm的长度，并且套管700突出泵环530的部分具有大约35mm的长度。
前述的大约尺寸仅用于所示实施例，并且应当理解在本发明其他实施例中，所述尺寸可成比例地或以其他方式改变。
该特定实施例的尺寸期望在泵环530的区域产生1.5到3.0m/s的血流速度，在流动通道240的区域产生1.0到1.5m/s的血流速度，以及在出口管600的区域产生0.5m/s的血流速度。驱动单元210构造为以10,000到33,000rpm的相对高的旋转速度运转。以那些速度，叶轮500在生理压力条件下将在每分钟4到61（升）的血的范围内移动。
可以预期具有上述尺寸的图1的示意性装置，在次要血流通道255中产生大于约20ml/分钟的流速，小于150N/m2的剪切率，小于大约200ms的过渡时间，并且其使电机的内表面保持在或低于大约44摄氏度。
为了保持足够的流体通过次要流动通道以阻止血块或其他沉淀物堆积在该近似尺寸及构造的小型泵中，已经确定了次要流动通道和主要流动通道之间的压力差应当不低于大约60mmHg。
在所示实施例中，通过使用上述横向分支出口管600获得所需的压力差，该出口管造成次要压力上升。另外，如图1所示，次要流动通道255可通过定位在叶轮500后面的小缺口560而连接在主要流动通道上并且在与通过主要流动通道的流动方向大约垂直的方向上运行。该缺口560可有助于产生“水泵”效益，其减小了次要流道255内的压力并且有助于在与通过主要流动通道240的流动相反的方向上引导血液通过次要流动通道255。
图1的示意性心周血泵可通过心壁中的穿孔插入并且以这样的方式引入心内：使壳体200密封地关闭穿孔，同时套管700位于心脏内部并且出口管600位于心脏外。可以不移除心壁组织而形成心壁内的穿孔。这有利于在将来拔出泵后封闭心壁中的孔。为了泵更好地轴向固定在心壁上，可在壳体200上提供周边放大部分290。
通过如上所述布置血泵，壳体200和套管700的长度的主要部分位于心脏的内部，同时壳体200相对短的部分从心脏突出，并且出口管600与连接出口管600的软管一起紧靠心脏外侧。因此，血泵不占用胸腔内的大量空间。
血泵可植入开放的心内以在手术或其他干预期间提供心脏维持或提供手术后的更长时期的维持。小型泵的优势在于在患者胸区域不需要承受重且体积大的泵。另外，泵很小且轻，甚至脆弱的右或左心房在使用并且引入该泵时都不会明显变形。在所有的情况中，可能以空间节省的方式影响泵的定位，并且将对进入心的干扰和阻碍尽可能地降至最低。
如图2所示，上述系统还可用于基于导管的血管内装置中。在该实施例中，基于导管的泵包括承载定子电动磁铁320以及定子轴承磁铁310a、310b的壳体200。转子400承载转子电动磁铁420、转子轴承磁铁410a、410b，以及叶轮500。该转子和定子轴承磁铁配合以形成前面和后面的径向磁轴承。
在该实施例中，旋转叶轮产生通过主要血流开口245流过壳体外侧的主要血流。位于主要血流开口245的下游的次要血流主要开口285在转子400和包括定子磁铁的壳体200之间形成次要血流通道255。与图1的实施例一样，该次要血流通道255通常是与主要血流通道相反的方向。通过次要血流通道255的血流有助于阻止血块或其他血液沉淀物堆积在电机内。
在该实施例中，轴向磁轴承，其可以是无源的、有源的、或两者都可，可位于转子后侧并且如上所述抵消向前牵引转子的力。在其它实施例中，轴向力可通过液压或接触球轴承实现。
因此已描述了本发明至少一个实施例的几个方面，应当理解对于本领域技术人员来说将容易实现各种改变、修改以及改善。这种改变、修改以及改善将要成为本公开的一部分，并且要位于本发明精神和范围内。因此，前面的描述和附图仅仅是为了举例。

Claims (18)

1.一种血泵，包括：
管状壳体；
驱动单元，包括电磁电机，该电磁电机包括：
转子，其包括转子电机磁体和一对转子轴承磁体；以及
定子部分，其包括定子电机磁体和一对定子轴承磁体，该定子电机磁体构造为使得所述转子旋转，
所述驱动单元与所述管状壳体同轴布置并且布置在所述管状壳体内以产生沿所述管状壳体的长度轴向延伸的主要流动通道，该主要流动通道构造为允许血液在第一方向上流动，该主要流动通道构造为在所述驱动单元和所述壳体之间的环形空间内产生围绕该驱动单元的主要流动；
叶轮，布置在所述驱动单元的一端并且连接所述转子；
泵环，具有轴向入口，定位在所述壳体的一端并且围绕所述叶轮的至少一部分；
套管，从所述壳体最靠近所述叶轮的一端延伸，其中该套管构造为延伸穿过患者的心脏壁，并且至少部分定位在患者的心脏内部；以及
直的横向分支的出口管，定位成与所述壳体背离所述叶轮的一端相邻，并且在大致垂直该壳体的方向上从该壳体延伸；
其中，所述驱动单元包括：
形成在所述转子电机磁体和构造为使得所述转子旋转的所述定子电机磁体之间的次要流动通道，该次要流动通道构造为允许血液在大致与所述第一方向相反的第二方向上流动；以及
将所述次要流动通道设置成与所述主要流动通道流体连通的连接通道；
其中，所述出口管和连接通道的至少一者构造为在所述主要流动通道和次要流动通道之间产生正的压力差。
2.根据权利要求1的血泵，其中所述连接通道设置成大致垂直于所述第一方向。
3.根据权利要求1的血泵，进一步包括靠近所述叶轮定位在所述驱动单元内的第一径向磁轴承以及朝向所述驱动单元背离该叶轮的一端定位的第二径向磁轴承。
4.根据权利要求1的血泵，进一步包括与所述驱动单元最靠近所述叶轮的一端相邻的轴向液压轴承。
5.根据权利要求4的血泵，其中所述轴向液压轴承包括适合允许血液流过所述轴承的开口。
6.根据权利要求1的血泵，进一步包括与所述驱动单元背离所述叶轮的一端相邻的轴向磁轴承。
7.根据权利要求6的血泵，其中所述轴向磁轴承至少部分是有源的。
8.一种血泵，包括：
管状壳体；
驱动单元，包括电磁电机，该电磁电机包括：
转子，其包括转子电机磁体和一对转子轴承磁体；以及
定子部分，其包括定子电机磁体和一对定子轴承磁体，该定子电机磁体构造为使得所述转子旋转，
所述驱动单元与所述管状壳体同轴布置并且布置在所述管状壳体内以产生沿所述管状壳体的长度轴向延伸的主要流动通道，该主要流动通道构造为在所述驱动单元和所述壳体之间的环形空间内产生围绕该驱动单元的主要流动；
叶轮，布置在所述驱动单元的一端并且连接所述转子；
泵环，具有轴向入口，定位在所述壳体的一端并且围绕所述叶轮的至少一部分；
套管，从所述壳体最靠近所述叶轮的一端延伸；以及
横向分支的出口管，定位成与所述壳体背离所述叶轮的一端相邻；
其中，所述驱动单元包括：
形成在所述转子电机磁体和构造为使得所述转子旋转的所述定子电机磁体之间的次要流动通道；以及
将所述次要流动通道设置成与所述主要流动通道流体连通的连接通道；
其中，所述出口管和连接通道的至少一者构造为在所述主要流动通道和次要流动通道之间产生正的压力差。
9.根据权利要求8的血泵，其中所述连接通道设置成大致垂直于所述主要流动通道的方向。
10.根据权利要求8的血泵，进一步包括靠近所述叶轮定位在所述驱动单元内的第一径向磁轴承以及朝向所述驱动单元背离该叶轮的一端定位的第二径向磁轴承。
11.根据权利要求8的血泵，进一步包括与所述驱动单元最靠近所述叶轮的一端相邻的轴向液压轴承。
12.根据权利要求11的血泵，其中所述轴向液压轴承包括适合允许血液流过所述轴承的开口。
13.根据权利要求8的血泵，进一步包括与所述驱动单元背离所述叶轮的一端相邻的轴向磁轴承。
14.根据权利要求13的血泵，其中所述轴向磁轴承至少部分是有源的。
15.根据权利要求8的血泵，其中所述血泵构造为将通过所述次要流动通道的流速保持在大于20ml/分钟。
16.根据权利要求8的血泵，其中所述血泵构造为产生通过所述次要流动通道的流动的剪切率小于150N/m2。
17.根据权利要求8的血泵，其中所述血泵构造为产生通过所述次要流动通道的流动的过渡时间小于200ms。
18.根据权利要求8的血泵，其中所述血泵构造为产生在所述主要流动通道和次要流动通道之间的压力差至少为60mmHg。
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US20090118567A1 (en) 2009-05-07
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