EP3270986A1 - Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier - Google Patents

Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier

Info

Publication number
EP3270986A1
EP3270986A1 EP16714269.4A EP16714269A EP3270986A1 EP 3270986 A1 EP3270986 A1 EP 3270986A1 EP 16714269 A EP16714269 A EP 16714269A EP 3270986 A1 EP3270986 A1 EP 3270986A1
Authority
EP
European Patent Office
Prior art keywords
signal processing
heart pump
sensor
pump
heart
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16714269.4A
Other languages
German (de)
English (en)
Inventor
Sebastian Kallenbach
Helge Krambeck
Ralph BREUEL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Berlin Heart GmbH
Original Assignee
Berlin Heart GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Berlin Heart GmbH filed Critical Berlin Heart GmbH
Publication of EP3270986A1 publication Critical patent/EP3270986A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M60/126—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
    • A61M60/40—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
    • A61M60/10—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
    • A61M60/178—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
    • 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
    • A61M60/178—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
    • A61M60/183—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 drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD]
    • 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
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/226—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 radial components
    • A61M60/232—Centrifugal 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
    • A61M60/20—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
    • A61M60/242—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 with the outlet substantially perpendicular to the axis of rotation
    • 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
    • A61M60/50—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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
    • 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
    • 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
    • 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
    • A61M60/818—Bearings
    • A61M60/82—Magnetic bearings
    • 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
    • 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
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • 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
    • A61M60/88—Percutaneous cables
    • 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
    • A61M2205/16—General characteristics of the apparatus with back-up system in case of failure
    • 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
    • A61M2205/17—General characteristics of the apparatus with redundant control systems
    • 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
    • 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
    • A61M2205/3303—Using a biosensor
    • 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
    • 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
    • A61M2205/3365—Rotational speed
    • 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
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A61M2205/8243—Charging means by induction
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/62—Posture
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity

Definitions

  • the invention is in the field of electrical engineering and especially of medical technology and can be used concretely in connection with cardiac pumps.
  • implantable electric heart pumps have been known to support the human heart, such as LVAD (left ventricular assist device), RVAD (right ventricular assist device) or BiVAD (bi-ventricular assist device) may be executed and in this case blood from Move left ventricle into the aorta.
  • LVAD left ventricular assist device
  • RVAD right ventricular assist device
  • BiVAD bi-ventricular assist device
  • Such pumps are usually powered from outside the body with energy and also controlled.
  • one or more wired lines are provided, which supply and drive the actual heart pump, in particular a motor provided in the heart pump, with electrical energy.
  • data are collected within the implanted cardiac pump via sensors such as, for example, the rotor position of the heart pump, the pump temperature, the ventricular blood pressure, the blood temperature, and the position of the heart.
  • intrathoracic pressure and similar variables are received and processed by a located outside of the patient body control device, in particular also stored.
  • a number of wires are provided to carry all the data as well as the energy in the form of a single wiring through a combined transcutaneous or percutaneous cable, due to the large number of wires the cross section of the transcutaneous leads or the cable is relatively large, so that the skin passage site forms an increased risk of infection.
  • a combined line is stiff and prone to breakage by a large cross-section. The number of sensors is thereby limited, since the diameter of the combined line continues to grow due to additional lines to be added.
  • a continuously determined rotor position of the drive of the heart pump can be important for the drive control.
  • the present invention is therefore based on the object to connect an external control device for a cardiac pump device to a heart pump with the least possible effort and minimized risk of infection.
  • the invention thus relates to a heart pump device with an implantable heart pump, which has at least one sensor, wherein among the sensors at least one of the following sensors is: a position sensor for a rotor of the heart pump; a positional and / or occupational admirungssensor; a volumetric flow sensor; a temperature sensor; a pressure sensor; a pressure difference sensor; an oxygen saturation sensor; a chemical sensor for blood analysis.
  • the heart pump assembly further includes a controller connected to the heart pump via a transcutaneous or percutaneous lead.
  • a transcutaneous lead is understood to mean a lead through the skin.
  • a percutaneous lead for example, runs entirely in the body and is often guided at least at one point in the vicinity of the skin surface and, for example, coupled with a TET (transcutaneous energy transfer) system.
  • the TET system is configured such that, in addition to energy, preferably digital data can also be exchanged.
  • the invention relates to a signal processing device, which is connected on the one hand by means of the transcutaneous or percutaneous line to the control device and on the other hand connected to at least one sensor of the heart pump and transmits signals of the at least one sensor to the control unit in a first operating state.
  • the transmission of the signals takes place in some embodiments via the transcutaneous or percutaneous line.
  • the signal processing device can be implanted and directly connected to one or more sensors of the heart pump and makes preprocessing of the signals from one or more sensors such that these signals can be transmitted in a simplified manner, for example via the transcutaneous or percutaneous line.
  • the Signal kauseinrich device in a first operating state of the heart pump device a plurality of signals to be transmitted - or len in some mecanicsbeispie all signals to be transmitted - of sensors and transmit via an executed as a data bus transcutaneous or percutaneous line.
  • the transcutaneous line may for this purpose have one or more wires of electrical conductors and serve as a line for a serial or parallel bus. It is also a transmission via an optical Signal line by the signal processing device possible. In addition, it is possible to combine the energy-transmitting lines with the data-transmitting lines (power-line communication).
  • the signal processing device can store data of the individual sensors and, for example, also store corresponding data for a calibration of the signals.
  • This has the advantage that the data can be interpreted in the control device independently of the further communication path which they travel between the signal processing device and the control device.
  • the information arriving at the control device is not dependent on the individual pairing between a heart pump and a control device. When replacing the control device thus no calibration or initialization must be done with a specific heart pump. This leads to major simplifications in the storage and installation of control devices. It also eliminates the need to set up and use each heart pump and control device as a fixed pair.
  • the signal processing device is connected in at least one of the above-mentioned sensors in some embodiments.
  • at least one of the sensors is a position sensor of a rotor of the heart pump.
  • the position sensor is, for example, a sensor that represents the position of the rotating rotor of an electric motor in the heart pump.
  • the transmission of such position data is important for the control of brushless electric motors in particular, which are used in medical technology with advantage, since they are extremely efficient, easy to control and low maintenance.
  • sensor for the position of the rotor of the heart pump can serve also a sensor, which by determination of current and tension of a brushless Electric motor determined by arithmetic way on the rotor reaction, the angular position of the rotor / rotor.
  • the signal processing device may also be connected to other sensors, for example, two, three, four or more sensors, which sensors may be provided in or on the heart pump and formed, for example, as one of the above sensors or as pump temperature tursensor, blood pressure sensor or blood temperature sensor are.
  • the signal processing device and the implantable heart pump, together with the sensors used, can be calibrated during commissioning or at the factory prior to commissioning, wherein calibration is carried out via known reference values and corresponding calibration parameters can be stored in the signal processing device.
  • the heart pump can work together with the signal processing device with each external control device without further calibration.
  • the external control device is thus replaceable without problems and can be used without further adjustment.
  • the signal processing device is advantageously arranged directly on the cardiac pump. This allows a problem-free joint implantation of heart pump and signal processing device and also short signal paths between the sensors of the heart pump and the signal processing device.
  • the signal processing device can also be mechanically held on the heart pump, for example, be mounted on this, so that thereby the relative position of the heart pump and signal processing device is clearly defined.
  • a further advantageous embodiment of the invention provides that a transmitting device is provided in the immediate vicinity of the heart pump, in particular is directly connected to this and processes the signals of at least one sensor and sent by means of a wireless connection.
  • the data acquired by the sensors can thus be transmitted by radio without the use of the transcutaneous line.
  • the transmitting device fails, is switched directly to the signal processing device and the transmission via the transcutaneous line.
  • the transcutaneous or percutaneous line is permanently required for the transmission of electrical energy in the form of a supply voltage of a motor of the heart pump.
  • a further advantageous embodiment of the invention provides that a switching module is provided within the signal processing device, which causes a second operating state is executed in the event of a failure of the signal processing device, in which the signal of the position sensor (or the respective sensor used), bypassing essential Parts of the signal processing device is transmitted directly via the transcutaneous or percutaneous line.
  • a position sensor is used for a rotor of a cardiac pump and the data acquired with this position sensor are processed in the first operating state of the cardiac pump device by means of the signal processing device and transmitted via the transcutaneous or percutaneous line
  • the signals in the second operating state are essentially not processed by the signal processing device but fed directly into the transcutaneous or percutaneous line. Since a continuous and reliable transmission of the axial position of the rotor and / or the Winkelposrtion the engine of the heart pump for the operation and the control of the motor depending on the Pumpentvp used can be very important, these sizes of the corresponding sensor must be transmitted with increased security.
  • the signal processing device may have a self-monitoring device, for example a so-called watchdog, which detects malfunctions and, in the case of malfunction by means of the switching module, redirects the signal path connecting the corresponding sensor, in particular the position sensor, to the signal processing device and further to the control device. in such a way that the signal from the sensor is routed past substantial parts of the signal processing device and directly to the control device via the transcutaneous or percutaneous line.
  • a self-monitoring device for example a so-called watchdog, which detects malfunctions and, in the case of malfunction by means of the switching module, redirects the signal path connecting the corresponding sensor, in particular the position sensor, to the signal processing device and further to the control device.
  • the signal from the sensor is routed past substantial parts of the signal processing device and directly to the control device via the transcutaneous or percutaneous line.
  • weather sensors are qualified such that in the case of a malfunction of the signal processing device, the signals supplied by them are passed through a switching module immediately and to essential parts of the signal processing device
  • the transcutaneous lead since the transcutaneous lead requires as few leads as possible, it is not necessarily possible to transmit all the sensor signals directly via the transcutaneous lead. However, the transmission of the most important signals via the transcutaneous or percutaneous line in the second operating state is also safe if the signal processing device fails, for example.
  • the signal processing means at least one memory device for storing system parameters, in particular
  • Parameters of the heart pump and / or measured values of one or more sensors.
  • Such a memory device permits the calibration of the pairing of the heart pump and the signal processing device as well as the storage of critical sensor data, upon the occurrence or exceeding of which, for example, alarm signals are to be output.
  • the signal processing device advantageously has a microcontroller and / or a transceiver, such as an RS485 transceiver.
  • the heart pump device is equipped for efficient data transmission by means of communication standards that are as little as possible prone to failure.
  • the signal processing device has at least one flexible, in particular bendable or foldable printed circuit board.
  • the signal processing device is usually constructed as an electrical circuit with individual circuit elements and / or integrated circuits, for example also ASICs. Due to the small space available, flexible or foldable printed circuit boards are suitable for the layout, which can be adapted according to the available space.
  • the signal processing device is arranged in a ring around an inflow or outflow channel of the heart pump.
  • the signal processing device may form an annular polygon surrounding an inflow or outflow line of the pump.
  • the signal processing device is arranged on a flat housing bottom of the heart pump.
  • a printed circuit board of the signal processing device can thus form a housing bottom of the pump or run parallel to a housing bottom of the pump.
  • the present invention also relates to a method for operating a cardiac pump device in one of the embodiments described above, in which the heart pump together with its signal processing device is connected to a control device and detected at the pump parameter and stored in the signal processing device. It follows that the pump is calibrated together with the signal processing device and optionally calibrated and thus that the heart pump with each control device works together without further adaptation would be necessary.
  • the necessary calibration parameters are stored and retrievable in the billing device of the signal processing device.
  • the signal processing device forwards preprocessed signals from sensors via a data bus by means of the transcutaneous or percutaneous line.
  • Fig. 1 shows a section through a heart wall with an implanted
  • Fig. 2 is a section through a heart wall with an implanted
  • Heart pump of the second type, 3 is a three-dimensional external view of a heart pump with a substantially polygonal annular circuit board surrounding an inlet port of the pump,
  • FIG. 4 shows a view of a bottom of a heart pump, in which a signal processing device is integrated
  • Fig. 5 shows the merging of the sensor data from various
  • FIG. 6 shows a signal processing device which, at least in the event of a fault, forwards the signal of a position sensor bypassing essential parts of the signal processing device via the transcutaneous line.
  • FIG. 1 shows an implantable heart pump 1, the inlet port 2 is embedded in a heart wall 3 in the region of the left ventricle, such that the pump 1 can convey blood from the heart chamber 4 in an artery, not shown.
  • the flow direction of the blood is indicated by the arrows 5, 6.
  • the heart pump 1 has a rotor 7 which on the one hand has electromagnetic drive elements, such as an armature, and on the other hand, conveying elements 8 in the form of blades, which convey blood, for example, in the axial direction 9 to the pump outlet 10.
  • sensors for various physiological variables such as the blood temperature and the ventricular pressure
  • sensors for measuring the temperature of elements of the pump an acceleration measurement sensor which gives information about a movement of the patient
  • a sensor that detects the angular position of the rotor of the pump In the area of the heart pump 1, sensors for various physiological variables, such as the blood temperature and the ventricular pressure, are usually arranged, as well as sensors for measuring the temperature of elements of the pump, an acceleration measurement sensor which gives information about a movement of the patient, and a sensor that detects the angular position of the rotor of the pump.
  • the rotor position sensor is particularly necessary when using a magnetic bearing to determine the axial rotor position. This forms an important input for the control of the bearing and thus the magnetic bearing of the rotor. This is the case, for example, with INCOR pumps from Berlin Heart GmbH.
  • FIG. 2 shows a heart pump 1 '
  • the inlet nozzle 2' is also embedded in the heart wall 3 in the region of the left ventricle 4, wherein the axis of rotation 9 'of the rotor T in the longitudinal direction of the inlet nozzle 2' extends.
  • the drive part 11 of the rotor with the armature and optionally also a winding in the Einiassstutzen 2 ' are housed, while the rotor part is arranged with the conveying elements 12 in the pump housing 13.
  • the rotor 12 accelerates the blood in the radial direction and partially in the tangential direction, so that it leaves the pump through the outlet port 10 '.
  • a brushed electric motor can be used.
  • FIG. 3 shows an external view of a heart pump 1 'with an inlet connection 2' and an outlet connection 10 'and a pump housing 13 of approximately cylindrical design, with a polygonal folded circuit board 14 around the inlet connection 2', which carries electrical components of a signal processing device. however, they are not shown in detail. Only a space-saving arrangement of the signal processing device around the inlet connection 2 'between the pump housing 13 and the heart wall 3 will be shown in FIG.
  • the circuit board 14 may have, for example, film-joint connections between individual, flat, flat circuit board parts, which may exceed the bending lines 15, 16, at the creases 15, 16.
  • Figure 4 shows a view of a pump housing 13 as seen from the bottom of the pump, wherein in the bottom of an insert 17 is installed, which can carry electrical components of a signal processing device. Also in this way, a signal processing device can be arranged to save space and protected directly to the heart pump ⁇ .
  • FIG. 5 shows in detail on the left side five sensors, namely an electron temperature sensor 18, an acceleration sensor 19, a blood temperature sensor 20, a ventricular pressure sensor 21 and a rotor position sensor.
  • tion sensor 22 each of which is connected to a microcontroller 23.
  • the microcontroller 23 forms, together with a bus interface 24, a signal processing device 34 which communicates bidirectionally with a control device 26 via the transcutaneous or percutaneous line 25.
  • sensor measured values are transmitted from the sensors 18, 19, 20, 21, 22 via the transcutaneous bus line 25 to the control device 26, and signals from the control device 26 to the heart pump, such as the drive of the heart pump, These include, for example, electrical signals for controlling the magnetic bearing.
  • the transcutaneous line 25 can also be used for transmitting electrical energy in addition to signal transmission.
  • the microcontroller 23 can summarize the signals of the sensors or a selection of the sensors and process them so that they can be sent to the control device 26 by means of a common communication protocol.
  • the necessary line capacitance of the transcutaneous line 25, for example the number of cores needed can be reduced to a minimum, so that the transcutaneous line becomes thin and flexible and thus less prone to breakage and also has a small outer surface and thus a smaller interface to the Provides tissue of the patient's body as a potential target for infection.
  • the tissue layer is indicated, through which the transcutaneous line 25 extends to the outside of the body, where the control device 26 is arranged.
  • the control device 26 is arranged in the case of a percutaneous line, for example, this would open in a TET interface in the body, which can be coupled to a corresponding TET interface arranged outside the body.
  • a controller could be located in the body, for example near the inboard TET interface and spaced from the pump or pump electronics.
  • the control device can also be arranged outside the body.
  • FIG. 6 shows that the microcontroller 23, starting from the rotor position sensor 22, can be bypassed by a bypass line 29. While in the first operating state, a multiplicity of sensor signals are processed by the signal processing device, the signal processing device digitizes the sensor signal or aggregates different signals, in the second operating state-for example in the event of a fault-the plurality of sensor signals or in some embodiments only a subset of the Sensor signals via the bypass line 29 and bypassing the microcontroller 23 to the outside of the body
  • the sensor data are passed from the sensors 18, 19, 20, 21, 22 to the Mikrocontrolier 23, processed there and from Mikrocontrolier 23, for example via an RS485 transceiver 24 'to the transcutaneous line
  • the signal of the rotor position sensor 22 or a signal reflecting the position of the rotor can additionally be passed through a low-pass filter, which is connected upstream of the microcontroller.
  • a control device for example a watchdog
  • a control device which checks the proper functioning of the microcontroller 23. If an error of the microcontroller 23 is signaled, then, for example, the monitoring device can actuate a switch 32, which is for example an analog switch and the
  • Heart pump device transferred from a first operating state to a second operating state, in which the signal of the rotor position sensor 22, which reaches him via the bypass line 29, is switched through to the transceiver 24 '.
  • the signal of the rotor position sensor immediately and without passing the microcontroller, so bypassing essential
  • FIG. 6 also shows a transcutaneous connection from the outside of the body to an implanted voltage supply 33.
  • the transcutaneous connection may be percutaneous.
  • the above-mentioned compound may also be formed percutaneously or transcutaneously.
  • the transcutaneous line 25 can thus be selected with as few wires and a small surface as possible, at the same time ensuring a high level of functional reliability of the heart pump and reliable controllability.

Abstract

L'invention concerne un dispositif de pompe cardiaque muni d'une pompe cardiaque implantable (1, 1') qui comprend au moins un capteur (18, 19, 20, 21, 22), au moins un capteur (22) parmi ceux-ci étant destiné à un rotor (7, 7') de la pompe cardiaque, et muni d'un dispositif de commande (26), qui est raccordé à la pompe cardiaque (1, 1') au moyen d'une conduite transcutanée (25), caractérisé par un dispositif de traitement des signaux (23, 24, 24', 31, 32), qui est raccordé d'une part au dispositif de commande (26) au moyen de la conduite transcutanée (25), et qui est raccordé d'autre part à au moins un capteur (18, 19, 20, 21, 22) de la pompe cardiaque et qui transmet des signaux d'au moins un capteur à l'unité de commande (26) par l'intermédiaire de la conduite transcutanée (25). Le dispositif de traitement des signaux est alors destiné à un prétraitement des données du capteur aux fins d'une transmission plus efficace par l'intermédiaire de la conduite transcutanée.
EP16714269.4A 2015-03-17 2016-03-17 Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier Withdrawn EP3270986A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15159496.7A EP3069741A1 (fr) 2015-03-17 2015-03-17 Dispositif de pompe cardiaque et son procédé de fonctionnement
PCT/EP2016/055810 WO2016146748A1 (fr) 2015-03-17 2016-03-17 Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier

Publications (1)

Publication Number Publication Date
EP3270986A1 true EP3270986A1 (fr) 2018-01-24

Family

ID=52686208

Family Applications (2)

Application Number Title Priority Date Filing Date
EP15159496.7A Withdrawn EP3069741A1 (fr) 2015-03-17 2015-03-17 Dispositif de pompe cardiaque et son procédé de fonctionnement
EP16714269.4A Withdrawn EP3270986A1 (fr) 2015-03-17 2016-03-17 Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP15159496.7A Withdrawn EP3069741A1 (fr) 2015-03-17 2015-03-17 Dispositif de pompe cardiaque et son procédé de fonctionnement

Country Status (4)

Country Link
US (2) US10449278B2 (fr)
EP (2) EP3069741A1 (fr)
CN (1) CN107427618A (fr)
WO (1) WO2016146748A1 (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018057795A1 (fr) * 2016-09-26 2018-03-29 Tc1 Llc Modulation de puissance pour pompe cardiaque
EP4233989A3 (fr) 2017-06-07 2023-10-11 Shifamed Holdings, LLC Dispositifs de déplacement de fluide intravasculaire, systèmes et procédés d'utilisation
EP3443993A1 (fr) * 2017-08-17 2019-02-20 Berlin Heart GmbH Pompe pourvue de capteur de rotor permettant la détermination des paramètres physiologiques, des paramètres de débit et des paramètres de mouvement
US10786612B2 (en) * 2017-09-26 2020-09-29 Heartware, Inc. Instrumented driveline using a flexible artificial skin sensory array
JP7319266B2 (ja) 2017-11-13 2023-08-01 シファメド・ホールディングス・エルエルシー 血管内流体移動デバイス、システム、および使用方法
DE102018201030A1 (de) 2018-01-24 2019-07-25 Kardion Gmbh Magnetkuppelelement mit magnetischer Lagerungsfunktion
CN112004563A (zh) 2018-02-01 2020-11-27 施菲姆德控股有限责任公司 血管内血泵以及使用和制造方法
DE102018211327A1 (de) 2018-07-10 2020-01-16 Kardion Gmbh Laufrad für ein implantierbares, vaskuläres Unterstützungssystem
JP2022540616A (ja) 2019-07-12 2022-09-16 シファメド・ホールディングス・エルエルシー 血管内血液ポンプならびに製造および使用の方法
WO2021016372A1 (fr) 2019-07-22 2021-01-28 Shifamed Holdings, Llc Pompes à sang intravasculaires à entretoises et procédés d'utilisation et de fabrication
EP4034192A4 (fr) 2019-09-25 2023-11-29 Shifamed Holdings, LLC Dispositifs et systèmes de pompes à sang intravasculaires et leurs procédés d'utilisation et de commande
CN110711275B (zh) * 2019-11-18 2021-04-27 苏州心擎医疗技术有限公司 用于体外血泵的马达、体外血泵、和体外血泵系统
DE102020102474A1 (de) 2020-01-31 2021-08-05 Kardion Gmbh Pumpe zum Fördern eines Fluids und Verfahren zum Herstellen einer Pumpe

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG170817A1 (en) * 2006-03-31 2011-05-30 Thoratec Corp Rotary blood pump
WO2011090927A1 (fr) * 2010-01-19 2011-07-28 Heartware, Inc. Vad à réactivité physiologique
WO2012012552A1 (fr) * 2010-07-22 2012-01-26 Thoratec Corporation Commande de pompes sanguines implantées
EP2736552B1 (fr) * 2011-07-28 2015-09-23 Fineheart Pompe cardiaque amovible, et procede mis en oeuvre dans une telle pompe
US20140066691A1 (en) * 2012-08-31 2014-03-06 Andre Siebenhaar Instability Detection Algorithm for an Implantable Blood Pump
DE102013013700A1 (de) 2013-04-05 2014-10-09 CircuLite GmbH Implantierbare Blutpumpe, Blutpumpensystem und Verfahren zur Datenübertragung in einem Blutpumpensystem
US9308305B2 (en) * 2014-06-18 2016-04-12 Ch Biomedical (Usa) Inc. Implantable blood pump with integrated controller

Also Published As

Publication number Publication date
US20180243490A1 (en) 2018-08-30
CN107427618A (zh) 2017-12-01
WO2016146748A1 (fr) 2016-09-22
US20200016309A1 (en) 2020-01-16
EP3069741A1 (fr) 2016-09-21
US10449278B2 (en) 2019-10-22

Similar Documents

Publication Publication Date Title
EP3270986A1 (fr) Dispositif de pompe cardiaque et procede pour faire fonctionner ce dernier
EP1847292B1 (fr) Dispositif médical implantable actif doté d'au moins deux fonctions diagnostiques et/ou thérapeutiques
DE10353950B4 (de) Steuerungssystem
EP2046415A1 (fr) Coeur artificiel
DE102014202276A1 (de) Energieversorgung-Spannungsüberwachungsschaltung, Sensorschaltung für ein Fahrzeug und Servolenkungsvorrichtung
EP3284490B1 (fr) Dispositif extracorporel de traitement du sang
EP2316502A1 (fr) Dispositifs de dialyse
EP3108809A1 (fr) Dispositif et procede de mesure de pression dans le c ur d'un patient
EP2098930B1 (fr) Système de surveillance pour un dispositif d'entraînement
WO2015024647A2 (fr) Article à usage unique pour le traitement par dialyse, appareil de dialyse et installation de traitement d'eau pour dialysat
DE102009035998A1 (de) Verfahren und Vorrichtung zum fehlersicheren Überwachen einer Bewegungsgröße an einem elektrischen Antrieb
EP3247613B1 (fr) Système de direction permettant une conduite automatisée d'un véhicule automobile
WO2020089429A1 (fr) Système et procédé de commande d'un dispositif d'assistance ventriculaire
EP1253490B1 (fr) Procédé et dispositif de surveillance sécurisée de la vitesse
DE102008048952A1 (de) Vorrichtung und Verfahren zur Steuerung einer elektrischen Lenkung
EP1593006B1 (fr) Surveillance de securite sans redondance pour un dispositif d'entrainement electrique (avec capteur de mesure)
DE602004010380T2 (de) Integrierte struktur zum nachweis von physiologischen signalen
WO2018109038A1 (fr) Dispositif de commande destiné à une pompe cardiaque implantable doté de deux unités de commande implantables et d'un commutateur implantable relié à ces dernières
EP3209349B1 (fr) Système comprenant plusieurs équipements médicaux
EP3658200B1 (fr) Appareil médical muni d'une interface de communication conçue pour la protection des patients et de l'opérateur
EP3374892B1 (fr) Appareil médical à assistance de l'utilisateur et procédé
EP3156085A1 (fr) Systeme d'assistance cardiaque dote de deux pompes
DE102021106537A1 (de) Elektrochirurgisches System, elektrochirurgisches Steuergerät, elektrochirurgisches Instrument und Verfahren zum Betrieb eines elektrochirurgischen Systems
EP2446921A1 (fr) Circuit de sélection pour un agencement d'électrodes et procédé de fonctionnement et de fabrication d'un agencement d'électrodes
EP1818309A1 (fr) Commande de grue

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20170914

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
RIN1 Information on inventor provided before grant (corrected)

Inventor name: KALLENBACH, SEBASTIAN

Inventor name: KRAMBECK, HELGE

Inventor name: BREUEL, RALPH

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Effective date: 20200316