WO2019234161A1 - Verfahren zur bestimmung eines fluid-volumenstroms durch ein implantiertes, vaskuläres unterstützungssystem und vaskuläres unterstützungssystem - Google Patents

Verfahren zur bestimmung eines fluid-volumenstroms durch ein implantiertes, vaskuläres unterstützungssystem und vaskuläres unterstützungssystem Download PDF

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Publication number
WO2019234161A1
WO2019234161A1 PCT/EP2019/064800 EP2019064800W WO2019234161A1 WO 2019234161 A1 WO2019234161 A1 WO 2019234161A1 EP 2019064800 W EP2019064800 W EP 2019064800W WO 2019234161 A1 WO2019234161 A1 WO 2019234161A1
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WIPO (PCT)
Prior art keywords
support system
heating element
cannula
temperature
fluid
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.)
Ceased
Application number
PCT/EP2019/064800
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German (de)
English (en)
French (fr)
Inventor
Hardy Baumbach
Julian Kassel
Inga Schellenberg
Martina BUDDE
Thomas Alexander SCHLEBUSCH
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Kardion GmbH
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Kardion GmbH
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Filing date
Publication date
Application filed by Kardion GmbH filed Critical Kardion GmbH
Priority to EP19729726.0A priority Critical patent/EP3801666B1/de
Priority to US15/734,004 priority patent/US12491357B2/en
Priority to JP2020567788A priority patent/JP7515176B2/ja
Priority to CN201980048719.3A priority patent/CN112533660B/zh
Publication of WO2019234161A1 publication Critical patent/WO2019234161A1/de
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M60/50—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
    • A61M60/10—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
    • 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
    • A61M60/20—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
    • 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
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor 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
    • 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. ultrasonic 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
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • 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
    • A61M2205/3368—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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the invention relates to a method for determining a fluid volume flow through an implanted vascular support system, a processing unit and an implantable, vascular support system.
  • the invention finds particular application in (fully) implanted Left Heart Support Systems (LVAD).
  • LVAD Left Heart Support Systems
  • Implanted left heart assist systems exist mainly in two variants.
  • a first common embodiment variant is (percutaneous) minimally invasive left heart assist systems.
  • the second widespread variant is inverted implanted apical left heart support systems under the thorax opening.
  • blood is delivered directly from the left ventricle into the aorta because the (percutaneous) minimally invasive left ventricular assist system is positioned centrally in the aortic valve.
  • the blood is delivered apically from the left ventricle via a bypass tube into the aorta.
  • the task of a cardiac support system is the promotion of blood.
  • the so-called heart-time volume (CO, usually expressed in liters per minute) has a high clinical relevance.
  • the heart-time volume relates here to the total volume flow of blood (from a ventricle), in particular from the left ventricle to the aorta.
  • the effort to use this parameter as a measured value during the operation of a cardiac support system is correspondingly common.
  • a delivery means such as a pump of the support system to the total volume flow of blood from the ventricle to the aorta
  • a certain volume flow reaches the aorta via the physiological path through the aortic valve.
  • the heart-time volume or the total volume flow (QHZV) from the ventricle to the aorta is therefore usually the sum of the pump volume flow (Q p ) and the aortic valve volume flow (Q a ). This can be expressed with the following relationship:
  • QHZV heart-time volume
  • An established method for determining the heart-time volume (QHZV) in the clinical setting is the use of dilution methods, all of which rely on a transcutaneously inserted catheter and therefore can only provide heart-time-volume measurement data during cardiac surgery. Since the acquisition of the heart-time volume (QHZV) by an LVAD is difficult to implement, Q p can be detected by suitable components of the LVAD. For high levels of support (ie, Q P / QHZV), Q a approaches zero, so that approximately Q p can be used as heart-time volume (QHZV).
  • Q p An established method for measuring the pump volume flow (Q p ) is the correlation of the operating parameters of the support system, in particular the electrical power consumption, possibly supplemented by other physiological parameters such as blood pressure. Since these methods are based on statistical assumptions and the underlying pump map of the LVAD used, the correlated Q p are error-prone. To increase the measurement quality of the parameter Q p , therefore, the inclusion of a flow sensor is desirable.
  • the object of the invention is to provide an improved method for determining a fluid volume flow in the area of an implanted vascular support system and to provide an improved implantable, vascular support system.
  • a method for determining a fluid volume flow through an implanted, vascular support system comprising the following steps:
  • the vascular support system is preferably a cardiac support system, more preferably a ventricular assist system.
  • the method is used to determine a fluid volume flow through a blood vessel or through a cross section of the blood vessel.
  • the blood vessel is, for example, the aorta, in particular in the case of a left heart support system, or the common trunk (trunk pulmonalis) in the two pulmonary arteries, in particular in a right heart support system, preferably around the aorta.
  • the method preferably serves to determine a fluid volume flow from a ventricle of a heart, in particular from a (left) ventricle of a heart to the aorta, through a (fully) implanted (left) ventricular (cardiac) support system ,
  • the fluid is usually blood.
  • the Support system is preferably located at the exit of the left ventricle of the heart or the left ventricle. Particularly preferably, the support system is arranged in aortic valve position.
  • the support system is preferably implanted such that it is at least partially, preferably completely or at least 50%, more preferably at least 85% or even at least 95% of its (outer) surface in the fluid flow. Further preferably, the support system is along at least 50%, more preferably at least 85% or even at least 95% of its length in the fluid flow.
  • one end of the support system in the region of which or where the electric motor is located, is located at least partially in the aorta.
  • the opposite end of the support system, in the region of which or at which a (inlet) cannula of the support system is located is located at least partially in a (left) ventricle of the heart.
  • the support system is preferably placed centrally in the aortic valve so that blood is drawn in distally from the ventricle and released proximally into the ascending aorta.
  • the support system is at least partially, preferably completely or at least 20%, preferably at least 40%, more preferably at least 50% or even at least 95% of its (outer) surface in a blood vessel, such as an artery, especially the aorta.
  • the support system is implanted to be (completely) in the (ascending or descending) aorta.
  • the fluid volume flow to be determined is that which flows through the support system (itself). In other words, this relates in particular to a fluid volume flow which only flows through the support system itself.
  • the fluid volume flow to be determined is generally the so-called pump volume flow (formula symbol Q p ), which quantifies (only) the flow through the support system itself.
  • the Method is particularly suitable for determining the pump volume flow (Q p ) of a (fully) implanted (left) ventricular cardiac assist system (LVAD), in particular in aortic valve position and / or by the support system itself.
  • LVAD ventricular cardiac assist system
  • the method is based in particular on (thermal) anemometric (measurement) principles for flow measurement.
  • the basic principle is that a flowing medium cools a hot body as a function of the flow velocity.
  • the method advantageously makes it possible to carry out a continuous, accurate measurement of Q p by means of a sensor integrated in an LVAD and based on thermal anemometry.
  • the heart-time volume may (at least approximately by Q p) and outside the operating scenario of comparable quality as application in comparison of a Dilutionskatheters be provided.
  • the solution proposed here is characterized in particular by an integration of one or more heating elements or one or more heating elements and one or more temperature sensors into an inlet cannula of a support system (VAD).
  • VAD support system
  • the method advantageously takes place a calculation of Q p from the measured voltage data at least one heating element and / or at least one temperature sensor.
  • three possible principles of action may be used, a constant current anemometry, a constant temperature anemometry or a pulse response method.
  • a determination of a fluid temperature parameter takes place in the region of a cannula of the support system.
  • a (separate) temperature sensor can be used.
  • the determination can be made by the heating element itself.
  • an electrical series resistance of the heating element can be used.
  • the fluid temperature parameter may be a (fluid) temperature, a temperature sensor current, a temperature sensor output (Current) signal or a (temperature-dependent) electrical resistance, in particular the heating element act.
  • a temperature sensor is preferably operated in the region of a cannula of the support system.
  • the operation comprises, in particular, measuring a fluid temperature and / or a change in the fluid temperature.
  • the temperature sensor is disposed on an inner surface or an outer surface of the cannula.
  • at least two temperature sensors can be provided. In this case, a temperature sensor upstream and a further temperature sensor can be arranged downstream of the heating element.
  • the cannula is in particular an inlet cannula, which can also be referred to as an intake tube.
  • the (inlet) cannula is preferably adapted to deliver fluid from a (left) ventricle of a heart to a turbomachine of the support system and / or to the aorta when implanted.
  • the temperature sensor or the temperature sensors are arranged at a distance from the heating element. This allows the advantage that the temperature sensor is not thermally influenced by the heating element, which is advantageous in particular when the temperature sensor represents a reference temperature sensor.
  • Thermistors, PTC thermistors, resistance elements such as platinum, semiconductor junctions or thermocouples can be used as the temperature sensor.
  • the temperature sensor or another temperature sensor can be introduced into the heating element or arranged on the heating element. If at least two temperature sensors are provided, it is preferred here that a reference temperature sensor is arranged at a distance from the heating element and a further temperature sensor is introduced into the heating element or is arranged on the heating element. If only one temperature sensor is provided, it may be necessary in this case that during a measurement of a reference temperature by the temperature sensor, the heating element is switched off or not operated in a heating state. Placement of a flat temperature sensor between cannula inner wall and heating element or placement of a temperature sensor on the heating element is preferred. A particularly preferred realization is a central placement of the temperature sensor in the heating region of the heating element. A possible form of realization would also be a three-layer structure, wherein a heating meander is placed between a lower and a middle polyimide film and a platinum wire meander as a temperature sensor between the middle and an upper polyimide film.
  • a reference temperature of the fluid is determined, in particular measured.
  • the reference temperature is determined by a reference temperature sensor, which is particularly preferably part of the support system.
  • the reference temperature sensor may be arranged in example in and / or on an (inlet) cannula of the support system.
  • the reference temperature usually represents a background temperature of the fluid, in other words a fluid temperature, which in particular is not thermally influenced by the heating element and / or a turbomachine of the support system.
  • a heating element is operated, which can cause a change in a fluid temperature in the cannula.
  • the heating element is set up and arranged so that it can cause a change in a fluid temperature in the cannula.
  • the heating element can be arranged directly inside the cannula or on an inner surface of the cannula.
  • the heating element it is (alternatively) possible for the heating element to be disposed in a wall of the cannula, on an outer surface of the cannula, or even spaced from the cannula, as long as the heating element is capable, for example by conduction, of a fluid temperature, at least part of the inside of the cannula to increase fluid.
  • To operate the heating element is usually driven with a current.
  • the heating element is formed with at least one heating filament or thermofilament.
  • a particular round or tubular heating element which lines the inner surface of the cannula at least in one segment region or circumferential section and / or longitudinal section.
  • the heating element is formed in the manner of a (flexible) heating foil, which at least partially covers the inner surface of the cannula.
  • At least one heating filament is particularly preferably arranged in or on the film.
  • the heating filament extends (for example meandering and / or in loops) in particular continuously over at least 50% of the or even the (entire) inner surface of the cannula lined by the foil. At least two heating filaments can be provided.
  • the heating or thermofilament is realized in-wall in the cannula (on the inside of the cannula wall), whereby advantageously a defined blood volume is examined and a heating z.
  • the aortic valve can be ruled out when slipping the support system. If more than one heating element or heating filament is provided, these can be arranged on opposite positions of the inner surface of the cannula. Further preferably, the heating elements or Schufil noir are jointly controlled or energized.
  • the heating element itself is used as a temperature sensor.
  • the heating element is adapted to both effect a change in a fluid temperature in the cannula and to detect, in particular measure, a change in a fluid temperature in the cannula.
  • the heating element in particular the Schufilament material (resistance change at Tempe- ratur skilledung)
  • the heating element itself can be used as a temperature sensor.
  • An advantageous embodiment of the heating element is therefore, for example, a (platinum) wire meander (meander-shaped heating filament made of a platinum alloy) between, for example, polyimide films or on a film.
  • the Fleizelement preferably has Fleizmäander made of conductive, resistive materials (eg Platinleg réelle) manufactured in the thin layer procedure.
  • the Fleizelement can be used by way of example as a temperature sensor that a Fleizelement- (series) resistance is measured.
  • the Fleizelement- (series) resistance for example, when Fleizer switched off or in a phase in which the Fleizelement not in a Fleiz state (eg, determined by a Fleiz Voltage and / or a Fleiz current) are measured.
  • the fleece element itself can be used as a temperature sensor, no (further or separate) temperature sensor has to be provided, and in step a), in this case, the Fleizelement can be operated instead of the (separate) temperature sensor.
  • the Fleizelement can be operated instead of the (separate) temperature sensor.
  • the (platinum) Fleizelement or the Fleizmäander could be used as a reference temperature sensor, in operation, ie when the Fleizelement operated in a Fleiz state is, as a Fleizelement and at the same time as an operating temperature sensor.
  • a (known) temperature dependence of a Fleizelement (series) resistor can be used.
  • the Fleizelement is here a regularly provided in addition to an electric motor of the support system component, which is in particular arranged separately from the electric motor.
  • a Fleizelement is understood here in particular as an electrically operable component which converts preferably at least 70%, more preferably at least 80% or even at least 90% of the electrical energy supplied to it into heat. Consequently, under a Fleizelement here no particular Electric motor that drives a turbomachine of the support system.
  • the fluid volume flow is determined using at least the fluid temperature parameter or its change and at least one Fleizelement operating parameter or its change.
  • the fluid volume flow is preferably determined using at least one temperature sensor operating parameter or its change and at least one Fleizelement operating parameter or its change.
  • a heating element operating parameter can be understood as meaning, for example, a heating element temperature, a Fleizelement flow or a Fleizelement output (current) signal.
  • a temperature sensor operating parameter may be taken to mean a temperature measured therewith, a temperature sensor current, or a temperature sensor output (current) signal.
  • a change here can be understood to mean, in particular, a pulse which can advantageously be emitted by the Fleizelement and detected by the temperature sensor.
  • the Fleizelement is operated with a defined electrical power.
  • a temperature of the heating element can be measured.
  • This (first) embodiment relates in particular to a so-called constant current anemometry. In constant current anemometry, the heating element is operated with a defined electrical power and the resulting temperature is measured.
  • the heating element is kept at a constant temperature.
  • an electrical power of the heating element can be measured.
  • This (second) embodiment relates in particular to a so-called constant temperature anemometer. In Constant Temperature Anemometry, the heating element is kept at a constant temperature and the required electrical power is measured.
  • the heating element is operated pulsed.
  • a change in a fluid temperature can be detected by means of a temperature sensor, in particular placed downstream of the heating element.
  • This (third) embodiment relates in particular to a so-called pulse response method.
  • the heating element is pulsed and the time is measured until the thermal pulse is measured at a downstream temperature sensor.
  • a binary random number sequence and the time delay are determined by an autocorrelator.
  • an additional consideration of the maximum amplitude of the response pulse in the calculation is preferred.
  • the fluid volume flow ascertained in step c) is preferably provided, for example in a step d), as a control parameter for the support system.
  • a processing unit of the support system can provide this control parameter as an output variable, in particular a control unit of the support system, which preferably controls the power of an electric motor and thus in particular also the (blood) delivery rate of the assistance system.
  • a processing unit is proposed, set up for carrying out a method proposed here.
  • the processing unit can have a memory in which calibration data can be stored. Alternatively or in addition to the calibration data, at least one (speed-dependent) memory may also be present in the memory. Calibration factor and / or a thermal model of the heating element be deposited.
  • the processing unit can include a microprocessor that can access the memory.
  • the processing unit preferably receives data from at least one heating element and / or at least one temperature sensor.
  • the processing unit may further comprise an electronic module for controlling and reading the heating element and the temperature sensor.
  • an implantable vascular support system comprising:
  • a heating element that can cause a change in fluid temperature in the cannula.
  • the support system is preferably a left ventricular cardiac assist system (LVAD) or a percutaneous, minimally invasive left heart assist system. Furthermore, this is preferably fully implantable. In other words, this means in particular that the means required for detection, in particular the reference temperature sensor, the motor temperature sensor and the current sensor are located completely in the body of the patient and remain there. Particularly preferably, the support system is set up or suitable for being able to be arranged at least partially in a ventricle, preferably the left ventricle of a heart and / or an aorta, in particular in the aortic valve position.
  • LVAD left ventricular cardiac assist system
  • a percutaneous, minimally invasive left heart assist system preferably fully implantable.
  • the support system is set up or suitable for being able to be arranged at least partially in a ventricle, preferably the left ventricle of a heart and / or an aorta, in particular in the aortic valve position.
  • the temperature measuring device is preferably formed with a temperature sensor. Furthermore, the temperature measuring device may also comprise a further temperature sensor. However, it is not mandatory that the temperature measuring device is provided separately from the heating element. Rather, the temperature measuring device can also be in the heating element and / or be formed by the heating element itself. Particularly preferred for this purpose is an (implicit) temperature measurement via a heating element serial resistor.
  • the support system comprises a turbomachine, such as a pump.
  • the support system has an electric motor.
  • the electric motor is regularly a component of the flow machine.
  • the support system is preferably elongate and / or tubular.
  • an (inlet) cannula and a flow machine are arranged in the region of opposite ends of the support system.
  • the support system further comprises a processing unit, configured for carrying out a method proposed here.
  • FIG. 1a is a percutaneous, minimally invasive left heart assist system 1 b shows a left heart assist system implanted invasively under the thoracic opening,
  • FIG. 2 shows an implanted, vascular support system that can carry out a constant current and constant temperature method,
  • FIG. 3 shows a component architecture of a support system according to FIG.
  • FIG. 4 shows an illustration of a control circuit of a support system according to FIG. 2,
  • FIG. 5 shows another implanted vascular support system that can apply a constant current and constant temperature method.
  • FIG. 6 shows another implanted vascular support system that can perform a pulse response method.
  • Fig. 7 shows another implanted vascular support system that can perform a pulse response method
  • FIGS. 1 a and 1 b Implanted left heart assist systems exist mainly in two variants, as shown in FIGS. 1 a and 1 b.
  • FIG. 1 a shows a (percutaneous) minimally invasive left heart assist system 7, while FIG. 1 b shows a left ventricular assistive system 8 implanted invasively under the thorax opening.
  • the variant of FIG. 1 a promotes blood directly from the left ventricle 9 into the aorta 10, since the (Percutaneous) minimally invasive left heart support system 7 is positioned centrally in the aortic valve 1 1.
  • the variant of FIG. 1 b promotes the blood api cal from the left ventricle 9 via a bypass tube 12 into the aorta 10th
  • FIG. 2 schematically illustrates an implanted aortic valve position vascular support system 2 that can perform a constant current and constant temperature method.
  • the support system 2 is an example of a left ventricular cardiac assist system (LVAD). tube-like elongated structure with a cannula portion, in which a (inlet) cannula 4 is formed, and with a connected to the cannula portion Strömungsmaschinenabêt in which a turbomachine 32 is arranged.
  • the support system 2 projects distally from the aorta 10 through the aortic valves 1 1 into the ventricle 9.
  • the (inlet) cannula 4 of the support system 2 protrudes into the ventricle 9.
  • a fluid volume flow 1 is conveyed, for example pumped, from the ventricle 9 into the aorta 10 using the turbomachine 32 (for example a pump which may have an electric motor) of the support system 2. Therefore, the fluid volume flow 1 is also referred to as pump volume flow (Q p ), which only quantifies the flow through the support system 2 itself.
  • the turbomachine 32 for example a pump which may have an electric motor
  • a certain aortic valve volume flow 26 reaches the aorta 10 via the physiological path through the aortic valves 11.
  • the fluid-time volume or the total fluid volume flow 27 (QHZV) from the ventricle 9 to the aorta 10 passing through the aorta 10 in the region of the support system 2 is accordingly the sum of the fluid volume flow 1 (FIG. Q p ) and aortic valve volume flow 26 (Q a ).
  • a temperature sensor 3 is arranged in the area of the cannula 4.
  • Flierzu is the temperature sensor 3 by way of example at the distal end of the cannula 4 (in the ventricle 9, where the fluid, such as blood, flows from).
  • the support system 2 has a heating element 5, which can cause a change in a fluid temperature in the cannula 4, for. B. by Joule heat or ohmic resistance heating when the Fieizelement 5 is energized.
  • the temperature sensor 3 is a reference temperature sensor which detects a reference temperature 21, which is the low-background blood temperature here by way of example.
  • the (reference) temperature sensor 3 is placed in the thermally uninfluenced blood flow in front of the heating element representing a heating element 5, here by way of example in the region before or upstream of the Fleizelement (s) 5.
  • Tempe- temperature sensor 3 can also be the value of another (second), z. B. on fleas of the Fleizelements 5 or downstream thereof arranged temperature sensor (see Fig. 5, 6: reference 24, Fig. 7: reference numeral 3) are used when the system is not in operation and thus this further temperature sensor not from the Fieizelement 5 is affected.
  • the water should be positioned in the support system 2 in such a way that it is not influenced by the heat emission of the Fleizelements 5, for example at the towards the ventricle 9 pointing tip of the support system 2 or the channel 4 and / or thermally decoupled upstream (the blood flow) from the Fieizelement 5.
  • an exemplary minimum distance of the reference temperature sensor to the fleizzle element 5 is determined in particular (mainly) from the thermal conductivity of the Support material. Distances of at least 5 mm [millimeters] are advantageous for non-metallic carrier material.
  • the operating principle here is based on determining, with a sufficiently known thermal capacity (formula C, reference numeral 23 in FIG. 4) of the fluid, here blood, the electrical power dQ necessary for heating the blood by a defined temperature dT is: f, _ ⁇ 30
  • measured energy flow dQ and temperature deviation dT determined from two measured (fluid) temperatures, the liquid volume V converted during the observation period or the fluid volume flow 1 (formula symbol Q).
  • the background blood temperature required for the difference dT can be calculated either via a (reference) temperature sensor 3 or from the value of a further temperature sensor (see above explanations) if the heating element was not active for a sufficient time.
  • the heating element 5 is formed here by way of example with a heating filament or thermofilament.
  • the thermofilament is inwandig in the cannula 4, which may also be referred to as an intake tube, realized, which advantageously investigated a defined blood volume and heating z.
  • the aortic valve 1 1 can be excluded when slipping of the support system.
  • FIG. 3 schematically shows a component architecture of a support system according to FIG. 2.
  • the support system 2 here comprises by way of example a control unit 13, a temperature sensor 3, and a heating element 5 embodied by way of example as a thermofilament or heating filament.
  • the control unit 13 is here an example of a component of a processing unit 6 of the support system 2.
  • FIG. 4 shows schematically an illustration of a control circuit of a support system 2 according to FIG. 2.
  • the reference symbols are used uniformly, so that reference is also made to FIGS. 2 and 3 for explaining the operation of the embodiment according to FIGS.
  • the exemplary control loop shown in FIG. 4 can be implemented in the control unit 13 according to FIG. 3, which in turn can be a component of the support system 2, in particular of a processing unit 6 of the support system 2.
  • the control loop comprises a regulator 14 and the heating element 5.
  • the disturbances influencing the heating element 5 (controlled system) are the reference temperature 21, the fluid volume flow 1 and the heat capacity 23 (of the fluid, here blood).
  • the controlled variable here is the current 20 and is fed back to the controller 14. In this case, there is a common return of the current 20 (controlled variable) and the voltage 19 (manipulated variable) by the determined actual power 17.
  • the control deviation 18 results from a subtraction of the actual power 17 of the target power 16.
  • the interference mentioned fluid Volumetric flow 1, reference temperature 21 and heat capacity 23 and the current 20 (controlled variable) and the voltage 19 (manipulated variable) are also provided to a computing unit 15, the voltage 19 and the current 20, the actual power 17 and the actual electrical resistance 22 of the heating element 5 is determined and, in addition, the heating element temperature 25 is determined from the electrical actual resistance 22 (for example due to the known temperature dependence of the resistance).
  • the calculation unit 15 calculates therefrom the fluid volume flow 1, wherein it can be provided as averaged volume flow.
  • the heating element 5 is here exemplified by the controller 14 in the control unit 13 applied with constant power and both the electrical resistance 22 for measuring the heating element temperature 25, as well as the reference temperature 21 from the reference temperature sensor 3 read (or heater resistor 22 with the heater off (ie, the heating element 5 is not operated in a heating state) for determining the reference temperature 21).
  • the calculation unit 15 the calculation of the fluid volume flow 1 or Q p on the basis of the electrical Thompsonelementtsch 17, the basis of the electrical resistance 22 of the heating element 5 determined Schuelementtem- temperature 25 and the reference temperature 21 takes place.
  • the heating element temperature 25 of the heating element 5 is here held by way of example by the controller 14 at a defined temperature or at a defined temperature elevation above the reference or background temperature 21.
  • the fluid volume flow 1 or Q p is calculated in the calculation unit 15 of the control unit 13.
  • FIG. 5 schematically shows another implanted vascular support system 2 that can perform a constant current and constant temperature method.
  • the support system 2 according to FIG. 5 has many features in common with the support system 2 according to FIG. 2, so that to that extent reference is made to the above statements regarding FIG. 2.
  • the embodiment of FIG. 5 differs from that of FIG. 2 in that a further (second) temperature sensor 24 is thermally coupled to the heating element 5 so that the temperature determination of the heating element 5 does not exceed the electrical resistance 22 of the heating element 5 but can take place over the electrical resistance of the further temperature sensor 24.
  • FIG. 6 schematically shows another implanted vascular support system 2 that can perform a pulse response procedure.
  • a further temperature sensor 24, which is preferably arranged inwardly in the cannula 4, is set down spatially from the heating element 5 (in the direction of the flow machine 32, downstream of the heating element 5), so that transit time and thermal dilution effects can be observed.
  • an optional (see Fig. 7) reference temperature sensor formed here by the temperature sensor 3 is placed upstream to determine the reference or background temperature 21 of the fluid (here: blood).
  • 5-10 mm spacing is good values.
  • the heating element 5 is acted upon by a power pulse 31 and brings a defined amount of energy E p in the blood volume of the cannula 4, which leads to an increase in the blood temperature.
  • E p energy in the blood volume of the cannula 4
  • the (pump) activity of the turbomachine 32 the blood flows with a Q p -dependent flow velocity in the direction of the further temperature sensor 24, the p -dependent after a Q runtime At a maximum temperature T m observed tet.
  • E p or the Schuelementadosit 17 is at At, the reference temperature 21 and T m in the control unit 13, the fluid flow rate 1 or Q p calculated (running time At or running time At and amplitude height T m ).
  • the observable effects are both a transit time, wherein a high fluid volume flow 1 corresponds to a short transit time from the heating element 5 to the further temperature sensor 24, as well as due to the solid thermal resistance of the heating element 5 to the blood volume and the fixed thermal capacity 23 of the blood, a change in amplitude, wherein a slow fluid volume flow 1 of a strong increase in temperature further Temperature sensor 24 and a high flow of a small temperature turerhöhung corresponds.
  • FIG. 7 schematically shows another implanted vascular support system 2 that can perform a pulse response procedure.
  • the support system 2 according to FIG. 7 has many features in common with the support system 2 according to FIG. 6, so that reference is made to the above explanations regarding FIG. 6 in this respect.
  • the difference is that only one temperature sensor 3 is provided in FIG. This is preferably innwandig in the cannula 4 fulfills the purpose here, the other temperature sensor 24 in the embodiment of FIG. 6 met.
  • the embodiment of FIG. 7 does without (separate) reference temperature sensor.
  • FIG. 8 shows schematically temporal measured value profiles for the support system 2 according to FIG. 6 or FIG. 7.
  • the temperature sensor arranged downstream of the heating element 5 (reference number 24 in FIG. 6 and reference number 3 in FIG. 7) measured temperature curves over time 29, wherein the temperature was measured as a voltage value via an analog-to-digital converter, so that both the voltage 19, and an analog-to-digital converter output 28 over time 29 are plotted.
  • Various measured value profiles are entered, namely a first measured value profile 34, a second measured value profile 35, a third measured value profile 36, a fourth measured value profile 37, a fifth measured value profile 38 and a sixth measured value profile 39, wherein the measured value profiles follow decreasing fluid volume flow (pump volume flow)
  • the temperature profile at the temperature sensor at low and measured value progression 34 represents the temperature profile at the temperature sensor at a high fluid volume flow.
  • the time difference 30 until the pulse 31 of the measured value course 39 has been measured has been marked. It can be clearly seen that the time difference 30 is inversely proportional to the fluid volume flow, as is the amplitude (the maximum) of the measured value profile.
  • the amplitude the maximum
  • a method for determining a fluid volume flow 1 through an implanted, vascular support system 2 comprises the following steps:
  • An implantable, ie in the human or animal body can be arranged vascular support system contains a Temperaturmesseinrich- tion in the region of a cannula 4 of the support system 2 and has a heating element 5, which can cause a change in fluid temperature in the cannula (4).

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PCT/EP2019/064800 2018-06-06 2019-06-06 Verfahren zur bestimmung eines fluid-volumenstroms durch ein implantiertes, vaskuläres unterstützungssystem und vaskuläres unterstützungssystem Ceased WO2019234161A1 (de)

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EP19729726.0A EP3801666B1 (de) 2018-06-06 2019-06-06 Implantiertes, vaskuläres unterstützungssystem mit mitteln zur bestimmung des fluid-volumenstroms eines durch dieses fliessenden fluids
US15/734,004 US12491357B2 (en) 2018-06-06 2019-06-06 Systems and methods for determining a blood volume flow through a cardiac support system and vascular support system
JP2020567788A JP7515176B2 (ja) 2018-06-06 2019-06-06 埋め込まれた血管補助システムを通る流体体積流量を決定する方法および血管補助システム
CN201980048719.3A CN112533660B (zh) 2018-06-06 2019-06-06 用于确定通过植入式血管支持系统的流体体积流量的方法和血管支持系统

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DE102018208870.5A DE102018208870A1 (de) 2018-06-06 2018-06-06 Verfahren zur Bestimmung eines Fluid-Volumenstroms durch ein implantiertes, vaskuläres Unterstützungssystem
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US20210346674A1 (en) 2021-11-11
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