CN1976730A - 心外膜支持和/或承担心脏功能的装置 - Google Patents

心外膜支持和/或承担心脏功能的装置 Download PDF

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CN1976730A
CN1976730A CNA2005800148559A CN200580014855A CN1976730A CN 1976730 A CN1976730 A CN 1976730A CN A2005800148559 A CNA2005800148559 A CN A2005800148559A CN 200580014855 A CN200580014855 A CN 200580014855A CN 1976730 A CN1976730 A CN 1976730A
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inner membrance
heart
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CN1976730B (zh
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M·弗拉利
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PPA Tech AG
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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
    • A61M60/10—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
    • A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
    • 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
    • A61M60/20—Type thereof
    • A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] 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
    • A61M60/40—Details relating to driving
    • A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
    • A61M60/468—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • 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
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure 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
    • 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
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/878—Electrical connections within the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

本发明涉及一种心外膜支持和/或承担心脏功能的装置，所述装置带有一个双膜(1)，所述双膜具有一个弹性的内膜(2)和一个不可膨胀的外膜(3)，以及构成于其间的、封闭的、可以借助于一种流体充胀和缩瘪的空腔(4)。本发明旨在如此地改善这样地装置：使得可以在关键的术后期以一种简单的方式可以刺激心脏。为此在内膜(2)的向着心脏(5)的内侧(6)上安排至少一个探头/电极单元(7、8)，用于心外膜导出EKG和/或一个外部的心脏起搏器的信号传输和信号变换。

Description

心外膜支持和/或承担心脏功能的装置
技术领域
本发明涉及一种心外膜支持和/或承担心脏功能的装置，其带有一个双膜，所述双膜具有一个弹性的内膜和一个不可膨胀的外膜，以及构成于其间的、封闭且可以借助于一种流体充胀和缩瘪的空腔。
背景技术
一种这样的装置例如从专利文献DE19951220A1中所公知，然而却是心包工作的。其涉及一种较少侵入性的，也就是说可以经皮植入的用于机械支持心脏泵血功能和临时替代心脏的泵血功能的系统。在探查心包以后把所述装置以折叠起来的状态经皮安装进心包中，或者在一个手术结束时以外科方式布置在心包中，并且在心包中用所述双膜包住右心室和左心室。在此在缩瘪状态下所述装置薄得可以避开邻近器官的压迫。在植入以后，双膜的空腔经过一个连接软管有节律地充盈一种流体，所述流体既可以是一种气体(氦或者CO2)也可以是一种适当的液体。通过这种有节律地充胀和缩瘪所述双膜的空腔并且由于所述外膜与内膜相反是不可膨胀的，通过该包绕心脏的双膜达到心脏的压力传送和压缩。在此把血液从右心室排入肺动脉并且同时从左心室排入主动脉，或者在心脏尚有泵血功能的情况下支持心肌的收缩期排血工作。
然而当前每名在心脏上进行手术处置的患者都要在手术结束时在心外膜上缝合一个临时的起搏器探头。在该关键的术后期中出现心搏停止(电的心搏停止)或者心动过缓(心搏过慢)的情况下，可以借助于这两个临时探头通过一个外部连接的起搏器刺激心脏。在五到七天以后拆除所述探头电缆，这可以无需新的胸腔开口。然而事实表明缺点是每次都必须缝合上所述临时起搏器探头。
如果在术后阶段出现室性心律紊乱(室性心动过速或者心室纤维性颤动)，就必须用一个除颤器把心脏重新转回正常心律。在此要采用一种可以从外部放在身体上的除颤器，然而，关于这种除颤器公知的是，由所述除颤器以电功的形式产生的能量(200至360瓦秒Ws)只有10％至20％直接作用在心脏上，而主要部分由周围组织吸收。另一方面采用了可植入的除颤器，并在心室中植入探头，该探头一般长年保留在患者体内。然而对此还是公知一般地只有30％至50％的由植入的除颤器产生的能量(16至34瓦秒)作用在心脏上。
以所述的缺点，也就是要求缝合一个临时的起搏器探头和采用公知除颤器时很大的能量损耗的缺点为背景，本发明的任务是改进开头所述技术的一种装置，从而提供一种在高危的术后期的心脏刺激的简单的可能性。
发明内容
根据本发明，在开头所述所属技术的一种心外膜支持心功能的装置的情况下，该任务通过下述特征完成的，在所述内膜的向着心脏的内侧上安排至少一个探头/电极单元，用于心外膜导出EKG和/或一个外部的心脏起搏器的信号传输和信号变换。
在此“探头”的概念理解为心脏电流或者心脏压力的测量传感器，而“电极”的概念理解为向心脏传输一种电刺激或者脉冲的电连接器件。
如本发明所述的装置的优点尤其在于，通过所述探头/电极单元(们)导出心外膜EKG并且利用心外膜EKG进行心包中的装置的触发、负荷控制，并且用作功能控制。在此所述功能控制包含在心律紊乱时触发一个报警到自动激活心脏起搏器或者所述探头/电极单元(们)的除颤功能。从而所述装置对通过外部导出的EKG常规触发产生一种有突出优点的替代方案。此外，如本发明所述的心外膜传感器应当通过所述探头/电极单元(们)的信号传输关于心脏本身功能的数据。从而可以在术后期监视患者的康复(“自主心脏功能恢复”)、发出加强指征的信号和指示取出所述装置的时间点。此外当然还可以有从“待机”(不支持心脏)向触发的加强(心脏本身部分地泵血)直至完全替代心脏功能(心搏停止)的自动切换。
本发明的有利扩展在从属权利要求2至9中予以限定。
优选的是，两个心室的每个都配属至少一个探头/电极单元，这使得如本发明所述的装置还可以用于双心室心功能不全。
为了使所述探头/电极单元(们)能够与患者体外的设备连接，优选地设置通到所述双膜的内膜的内侧的信号线路。
优选的是，在所述内膜上设置用于测量血液收缩压和舒张压的压力传感器，用所述压力传感器可以例如在心脏尚有泵血功能的情况下把如本发明所述的装置与心动同步。
如果所述压力传感器对一个外部的设备的信号传输通过通到所述内膜的内侧的信号线路进行，则对于所述压力传感器也是有利的。
优选的是，所述探头/电极单元(们)和压力传感器的信号线路安排在一个共同的连接插头中，所述连接插头可以连接在一个外部的控制单元或者驱动单元的对应终端上。
本发明提出可折地构成所述双膜，并且这样地构成所述探头/电极单元(们)以及压力传感器，使得不论是植入还是取出都可以通过一个经皮的导管进行。在此方面不论是手术中还是术后都不要求胸腔开放。
因为在冠状动脉搭桥术后不希望心外膜血管的外部压迫，所述双膜优选在大冠状动脉区域内具有可变的留空。这样的双膜可以具体地适应于患者制造，或者根据本发明的另一个有利的扩展也提出可以借助于可推移的支撑件适配患者心脏的特殊要求。在此可变的留空可以通过可折的、挠性桥接片或者半软管通过外科医生的机械操作设置在所希望的位置上。可以在泵血工作过程中或通过自粘特性，采用一种组织胶合剂，通过一个支架条，或通过所述双膜内部的规定确定位置的一些槽，把该可折的、挠性桥接片或者半软管保持在所希望的位置。
下面借助于附图详细地说明本发明的一个实施例。
附图的简要说明
在附图中：
图1：本发明所述的装置的一个示意图；
图2：一名具有一个植入了本发明的装置和一个外部的控制单元的患者的示意图；
图3：带有植入的本发明的装置的开放的患者胸腔；和
图4：带有安放好的装置和留空的人心脏图示。
图1示出一个心外膜支持和/或承担心脏功能的装置的示意图，所述装置带有一个双膜1，所述双膜具有一个弹性的内膜2和一个不可膨胀的外膜3，以及构成于其间的、封闭的并且可以借助于一种流体充胀和缩瘪的空腔4。在内膜2的向着心脏5的内侧6上安排配属给两个心室9、10的每一个一个探头/电极单元7、8，用于心外膜导出EKG和/或一个外部的心脏起搏器的信号传输和信号变换。所述探头/电极单元7、8借助于通到所述内膜2的内侧6的信号线路11、12与该图中未示出的外部控制设备或者驱动设备连接。
此外在所述内膜2的内侧6上安排用于测量血液收缩压和舒张压的压力传感器13、14，所述压力传感器同样通过通到所述内膜2的内侧6的信号线路15、16与该图中未示出的外部控制设备连接。这些信号线路11、12和15、16以及用于充胀或缩瘪空腔4的流体软管22在植入的状态下通过一个穿过患者胸骨附近皮肤的一个导入软管21布置。
图2示意地示出植入在一个抽象地示出的患者体内的双膜1的位置以及一个外部的控制和驱动单元23，信号线路11、12和15、16以及流体软管22通过导入软管21通到所述控制和驱动单元。
图3示出一个开放的患者身体，其带有一个示意地示出并且投影于其中的根据本发明的双膜1。功能器件7、8和13、14以及空腔4借助于流体软管22(在此仅通过一条直线示意地示出)并且借助于信号线路11、12和15、16连接在共同的连接插头17上，用所述连插头可以再把所述信号线路和所述流体软管以较简单的方式连接在(在该图中没有示出的)外部的控制和驱动单元23上。
图4示出一个带有示意地包绕于其上的双膜1的患者心脏，所述双膜的空腔4也可以通过流体软管22充胀和缩瘪。双膜1的该实施例在大冠状动脉血管的区域具有可变的留空18、19、20，以避免所述心外膜血管受外部压迫。这些留空18、19、20可以通过图中未示出的可推移的支架适配患者心脏的要求。

Claims (9)

1.心外膜支持和/或承担心脏功能的装置，所述装置带有一个双膜(1)，所述双膜具有一个弹性的内膜(2)和一个不可膨胀的外膜(3)，以及构成于其间的、封闭的并且可以借助于一种流体充胀和缩瘪的空腔(4)，
其特征在于，
在内膜(2)的向着心脏(5)的内侧(6)上设置至少一个探头/电极单元(7、8)，用于心外膜导出EKG和/或一个外部的心脏起搏器的信号传输和信号变换。
2.如权利要求1所述的装置，
其特征在于，
向两个心室(9、10)配属至少一个探头/电极单元(7、8)。
3.如权利要求1或2所述的装置，
其特征在于，
通到内膜(2)的内侧(6)的探头/电极单元(7、8)的信号线路(11、12)。
4.如权利要求1-3中任一项所述的装置，
其特征在于，
在所述内膜(2)上的用于测量血液收缩压和舒张压的压力传感器(13、14)。
5.如权利要求4所述的装置，
其特征在于，
通到所述内膜(2)的内侧(6)的压力传感器(13、14)的信号线路(15、16)。
6.如权利要求3至5中任一项所述的装置，
其特征在于，
信号线路(11、12；15、16)的一个共同的连接插头(17)。
7.如上述任一项权利要求所述的装置，
其特征在于，
如此可折地构成双膜(1)和探头/电极单元(7、8)以及所述压力传感器(13、14)，使得不论是其植入还是其取出都可以通过一个经皮导管进行。
8.如以上权利要求之一所述的装置，
其特征在于
双膜(1)在大冠状动脉血管的区域具有可变的留空(18、19、20)。
9.如权利要求8所述的装置，
其特征在于，
可推移的支架，借助于该可推移的支架可以使留空(18、19、20)适应患者心脏的要求。
CN2005800148559A 2004-05-11 2005-05-10 心外膜支持和/或承担心脏功能的装置 Expired - Fee Related CN1976730B (zh)

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PCT/EP2005/005051 WO2005110512A1 (de) 2004-05-11 2005-05-10 Vorrichtung zur epikardialen unterstützung und/oder übernahme der herztätigkeit

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CN102939117A (zh) * 2010-04-02 2013-02-20 阳光心脏有限公司 组合心脏辅助系统、方法和装置
CN104023787A (zh) * 2011-10-04 2014-09-03 T·J·奥克斯利 感应或刺激组织的活动
CN108136178A (zh) * 2015-10-08 2018-06-08 美敦力公司 用于将医疗电引线递送到心外膜植入位置的介入式医疗系统
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WO2005110512A1 (de) 2005-11-24
CN1976730B (zh) 2010-10-13
US7691047B2 (en) 2010-04-06
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