CN101678158A - 辅助心脏功能的导管 - Google Patents

辅助心脏功能的导管 Download PDF

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CN101678158A
CN101678158A CN200880006290A CN200880006290A CN101678158A CN 101678158 A CN101678158 A CN 101678158A CN 200880006290 A CN200880006290 A CN 200880006290A CN 200880006290 A CN200880006290 A CN 200880006290A CN 101678158 A CN101678158 A CN 101678158A
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M·沃纳
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Miracor Medizintechnik Handels und Entwicklungs GmbH
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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
    • F04D13/00—Pumping installations or systems
    • F04D13/02—Units comprising pumps and their driving means
    • F04D13/021—Units comprising pumps and their driving means containing a coupling
    • F04D13/024—Units comprising pumps and their driving means containing a coupling a magnetic coupling
    • F04D13/027—Details of the magnetic circuit
    • 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
    • A61M60/10—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
    • A61M60/13—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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    • A61M60/00—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
    • 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
    • A61M60/10—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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • 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
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • 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
    • A61M60/405—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • 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
    • A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
    • 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
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/523—Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • 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
    • A61M60/833—Occluders for preventing backflow
    • 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
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • 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

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Abstract

在一种带有至少一个泵(7)的辅助心脏(1)的功能的导管(2)中，泵在导管(2)的远端处形成为旋转泵，在远侧位于外侧的转子(6)通过磁耦联器与驱动轮(21)耦联，驱动轮(21)形成为液压或气动操作式桨轮且布置在导管(2)的内侧。驱动流体通过导管(2)的内腔(22)供应至桨轮，并通过导管的另一个内腔(23)被带出。

Description

辅助心脏功能的导管
技术领域
[0001]本发明涉及一种带有至少一个泵的辅助心脏功能的导管。
背景技术
[0002]在心力衰竭之后，例如心肌梗塞或其它原因导致心脏功能减弱之后，重中之重是要由重症监护医疗尽快使心脏功能再次恢复正常并稳定下来。例如，当由于衰竭而导致心脏输出量显著减少时，特别重要的是要可靠且快速地重新建立对应的外周血流，以防止继发性损害。心肺机的使用基本上允许重要的生命功能得以维持。但是，这种装置通常无法专门适应相应的实际需求。相反，常规的心肺机是这样的装置：使用外部泵来维持血液的强制循环，却不能系统地满足已被减弱或遭受衰竭的心脏的相应的需求的装置。
[0003]在外科手术中，特别是在静脉区，已经提出，通过泵从身体的静脉或在静脉中进行流体抽吸和流体返回来实施由静脉压控制的逆行灌注。这里使用常规导管，其内腔允许进行流体抽吸，且通过其内腔使在合适的地方返回成为可能。公知的装置，尤其是在心脏介入中在短暂的冠状动脉闭合期间在心肌保护区域内的冠状静脉中用于血液逆行灌注的装置，通常设计成使得可实施动脉硬化狭窄的冠状动脉的球囊扩张术。在这些情况下，可通过使抽出静脉的血液返回来实施分别短暂发生的且适于该介入的代偿。但是，就心脏全部功能的连续恢复而言，没有考虑会关系到心脏全部功能的标准，因此，这样的装置没有提供在特定时间段内的密集供应。与此同时，还必须维持其它器官的供应。
[0004]在从AT 407960B中已知的用于辅助心脏功能的装置中，流体通过外部泵从血管中去除，并通过返回导管返回到血管中，其中流体的返回量可根据测量值进行调节，并设置有心室导管以获得这些测量值。该公知装置包括装在带有传感器的心室腔中的心室导管，该传感器用于测量单位时间的流体量，其中，这些传感器在心室导管的引入状态下位于心室腔中，且这些传感器与求值电路连接，在该求值电路中求出每次心脏跳动或单位时间内舒张期容积与收缩期容积的比率，尤其是求出排出速率和/或单位时间内由心脏输送的输送量偏离限定的额定值的偏差，例如，额定值从关于心输出量的身体具体数据计算而得。以这种方式生成的信号被传递至泵，流体通过该泵被从心室腔中抽出并根据生成的信号再循环。
发明内容
[0005]本发明现在的目的是将这种公知装置进一步发展到这样的效果：即外部泵能够省却，且与此同时，能在特定位置系统地实现所期望的压力增大。具体地，由泵改善的流体流动将以这样的方式发展：即在期望的位置高度敏感流体(例如血液)的机械应力可保持得尽可能低，却仍可确保循环的相应改善。为了解决这个问题，可在上述装置的范围内使用且首先提到的根据本发明的导管的装置基本上在于，泵在导管的远端处构造成旋转泵，其中在远侧位于外侧的转子通过磁耦联器与驱动轮耦联，所述驱动轮布置在导管的内侧且形成为液压或气动操作式桨轮，驱动流体通过导管的内腔供应至桨轮并通过导管的另一个内腔被带出。与导管直接连接的这种轴向泵，可与导管一起被直接带入期望的位置，并且与此同时，在这里可与进一步治疗性附加措施(例如，通过借助球囊循环地闭塞血管而进行的逆行灌注)一起使用。为了保证与驱动泵的驱动介质完全脱离耦联，尤其是为了确保可以使用简单的驱动机构例如液压或气动操作式桨轮，通过根据本发明提供的磁耦联器实现了转子与驱动轮的完全不可渗透的分离，这消除了驱动轮和在远侧位于外侧的转子之间的轴向通道。据此，根据本发明的实施例被设计成，驱动轮形成为液压或气动操作式桨轮，驱动流体通过导管的内腔供应至桨轮并通过导管的另一个内腔被带出，其中优选桨轮构造成具有轴向或半轴向叶片。这样的布置可以通过相应地调节后的液压或气动储室以简单的方式操作，驱动介质通过相应的调节阀供应到与转子磁耦联的驱动轮。
[0006]该装置以结构上特别简单的方式设计成使得转子的旋转轴线与导管的纵轴线对齐或者平行。具有相应低磨损且不可渗透的导管的开发以及同时转子的牢固安装可这样实现：耦联器由条形磁铁形成，该条形磁铁位于由密封壁彼此液压分开的相邻腔室中，在导管的远端处分别与转子和驱动轮连接以便被锁定以防止相对旋转，其中优选地，驱动轮或转子与相应条形磁铁的连接件分别安装在腔室的壁中，所述壁背离密封壁且分别面向驱动轮或转子，其中该连接件被锁定以防止相对旋转。
[0007]转子本身可遵循如在WO 01/70300A1中描述的设计原理。该文献中所示出和描述的用于输送血液和其它高度敏感流体的旋转泵形成为外部电磁驱动泵，其不直接适合于结合到导管中。也就是说，该公知设计假设存在离心流动分量和对准壳体的流动分量，其中对准壳体的流动分量主要用于转子在壳体中的非接触安装和稳定。但是，采用转子位于导管远端处的这种布置，就流动技术而言不能很容易地实现封闭的壳体，因为这样的壳体壁必须实际上位于距转子精确限定的距离处，可是这在导管的远端处并不容易保证。然而，为了采用根据本发明的轴向泵实现所期望的输送能力，根据本发明也进行了这样的准备，即转子具有引导表面以产生离心流动分量。
[0008]为了能够操作用于逆行灌注的球囊，可在本发明的范围内使用驱动流体。据此，实施例优选地设计成使得用于驱动流体的内腔被引导通过以密封方式环绕着导管的可膨胀球囊，且内腔具有独立可控的关闭部件，驱动流体能够通过该关闭部件进入球囊或从球囊流出并进入相应的内腔，其中优选地，关闭部件形成为磁阀。球囊膨胀时需要额外的驱动介质，这些驱动介质在球囊塌陷时可被再次排出。借助于储室，这在体外的驱动侧是可能的。
[0009]根据本发明的辅助心脏功能的实施例源自根据AT 407960B的发展，其中，通过使用泵在血管中输送流体，且能够根据心室导管的测量值来调节所输送的量，由此来确定心输出量，且特征基本上在于，泵在导管的周边或远端处形成为血管内的旋转泵，该泵的位于外侧的转子通过磁耦联器与布置在导管内侧的驱动器连接。
附图说明
[0010]下面通过利用一个示例性实施例来进一步详细解释本发明，该实施例示意地示于附图中，在附图中：图1示出了泵和驱动器的布置的示意性图示，图2示出了根据本发明使用的导管的远端的示意性图示，图3示出了支承球囊的导管的一部分的局部放大图示。
具体实施方式
[0011]在图1中，心脏由1表示，心室导管2被引入到该心脏中。这里，该导管经由例如股动脉和主动脉弓3引入到心室腔中，并带有一系列传感器4，通过这些传感器4可确定量。测量信号传递到控制装置5。如下面在附图的其它图中另外示出的那样，心室导管形成有若干内腔，通过这样的内腔供应流体以驱动布置在远端处的转子，其形成辅助血液循环的泵，且在图1中由6表示。在图1中由箭头8标出了该转子的定位。转子或泵所用的驱动介质通过流体泵7导引成循环流动，该流体泵7可以根据控制装置5中生成的控制信号以同步的方式被调节。泵布置所在的远端区示意地由8表示，导管2在其远端处具有通向抽吸端10的管9。用于驱动流体的储室由11表示，其提供用于填充用来闭塞动脉的球囊12的额外驱动介质，并且再次接收球囊收缩时产生的驱动介质的介质量。
[0012]心室腔的容积测量允许可靠地检测出舒张期容积和收缩期容积之间的差异，并且允许对应的校正信号可用于同步的流体泵7的输出。此外，在控制电路5中，可提供对应的固定值例如限定的心输出量，在所测量的心输出量出现偏差时参考该固定值来控制泵。
[0013]可通过常规的、以对应同步的方式闭塞的球囊导管进行逆行灌注，使得在舒张期间实际上保证了定向回流。据此，可从ECG数据获得心率或舒张的正确时刻的对应测量值。
[0014]在图2中，现在示出了改良的导管2的远端。该导管的端侧13具有两个口袋形状的腔室14和15，在该腔室14和15中分别布置有条形磁铁。这里，条形磁铁16在远端处向外通过轴17与转子18连接，而位于内侧的条形磁铁19则通过轴20与驱动轮21连接。这里，驱动轮21形成为桨轮，并被经由内腔22的流体作用于其上，该流体再经由导管的内腔23流出。这里，通过对用于流体供应的内腔22中流体压力的对应的控制，而相应地调节桨轮21的旋转，其中，与桨轮21连接从而被锁定以防止相对旋转的磁铁19被设定成对应的旋转。在相对于内腔22和23完全密封的外侧，磁铁16随后被相应地带动并通过轴17驱动转子18，由此在管9区域中形成如箭头22所标示的流动，该流动辅助箭头25所示出的血管26中的自然血液流动。
[0015]在图3中，以放大的比例示出了以密封方式连接到导管2的球囊12的部分区域。从流体泵7离开和回到流体泵7的两个内腔依次由22和23表示。在球囊12的区域中，这些内腔的壁设有例如可被磁致动的阀。这些阀由27和28示意地标示。阀27的开口通向来自流体泵7的、处在由“+”号标示的压力之下且被泵入球囊12中的流体，由此，只要没有提供在图1中示意标示出的储室11，循环驱动流体的总量当然将减少。通过关闭阀27而封住闭塞，通过打开阀28能够引起球囊12的塌陷，现在流体经由内腔23被抽出并返回泵，内腔23处在由“-”号标示的略低的压力下。由于现在循环系统中流体的总量将要减少，因此必须将该量的一部分再次泵回到根据图1的储室11中。

Claims (9)

1.一种带有至少一个泵的辅助心脏功能的导管，其特征在于，泵(7)在导管(2)的远端处形成为旋转泵，在远侧位于外侧的转子(6)通过磁耦联器与驱动轮(21)耦联，所述驱动轮(21)布置在所述导管(2)的内侧且形成为液压或气动操作式桨轮，驱动流体通过所述导管(2)的内腔(22)供应至所述桨轮，并通过所述导管(2)的另一个内腔(23)被带出。
2.如权利要求1所述的导管，其特征在于，所述桨轮形成有轴向或半轴向叶片。
3.如权利要求1或2所述的导管，其特征在于，所述转子(6)的旋转轴线与所述导管(2)的纵轴线对齐或者平行。
4.如权利要求1、2或3中任一项所述的导管，其特征在于，耦联器由条形磁铁(16、19)形成，所述条形磁铁(16、19)位于由密封壁彼此液压分开的相邻腔室(14、15)中，在所述导管(2)的远端处分别与所述转子(6)和所述驱动轮(21)连接，以便被锁定以防止相对旋转。
5.如权利要求1至4中任一项所述的导管，其特征在于，所述驱动轮(21)或所述转子(6)与所述相应的条形磁铁(16、19)的连接件分别安装在腔室的壁中，所述壁背离所述密封壁且分别面向所述驱动轮(21)或所述转子(6)，其中所述连接件被锁定以防止相对旋转。
6.如权利要求1至5中任一项所述的导管，其特征在于，所述转子(6)具有引导表面以产生离心流动分量。
7.如权利要求1至6中任一项所述的导管，其特征在于，用于所述驱动流体的所述内腔(22、23)被引导通过以密封方式环绕着所述导管(2)的可膨胀球囊(12)，且所述内腔(22、23)带有独立可控的关闭部件，驱动流体能够通过所述关闭部件进入所述球囊(12)或从所述球囊流出而进入相应的内腔(22、23)。
8.如权利要求1至7中任一项所述的导管，其特征在于，所述关闭部件形成为磁阀(27、28)。
9.一种辅助心脏功能的装置，其中通过使用泵在血管中输送流体，并且所输送的量能够根据心室导管的测量值进行调节，由此来确定心输出量，其特征在于，泵(7)在导管(2)的周边或远端处形成为血管内的旋转泵，该泵(7)的位于外侧的转子(6)通过磁耦联器与布置在导管(2)内侧的驱动器连接。
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