WO2019234166A1 - Verfahren zur bestimmung einer strömungsgeschwindigkeit eines durch ein implantiertes, vaskuläres unterstützungssystem strömenden fluids und implantierbares, vaskuläres unterstützungssystem - Google Patents

Verfahren zur bestimmung einer strömungsgeschwindigkeit eines durch ein implantiertes, vaskuläres unterstützungssystem strömenden fluids und implantierbares, vaskuläres unterstützungssystem Download PDF

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Publication number
WO2019234166A1
WO2019234166A1 PCT/EP2019/064807 EP2019064807W WO2019234166A1 WO 2019234166 A1 WO2019234166 A1 WO 2019234166A1 EP 2019064807 W EP2019064807 W EP 2019064807W WO 2019234166 A1 WO2019234166 A1 WO 2019234166A1
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WIPO (PCT)
Prior art keywords
support system
flow
measurement
measurement result
operating parameter
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Ceased
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PCT/EP2019/064807
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German (de)
English (en)
French (fr)
Inventor
Thomas Alexander SCHLEBUSCH
Tobias Schmid
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Kardion GmbH
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Kardion GmbH
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Publication date
Application filed by Kardion GmbH filed Critical Kardion GmbH
Priority to AU2019282300A priority Critical patent/AU2019282300B2/en
Priority to ES19729729T priority patent/ES2975238T3/es
Priority to CA3105919A priority patent/CA3105919C/en
Priority to CN201980048728.2A priority patent/CN112566687B/zh
Priority to EP19729729.4A priority patent/EP3801668B1/de
Priority to US15/734,523 priority patent/US12310708B2/en
Priority to JP2020567982A priority patent/JP7269667B2/ja
Publication of WO2019234166A1 publication Critical patent/WO2019234166A1/de
Anticipated expiration legal-status Critical
Priority to US19/218,061 priority patent/US20250281060A1/en
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A61B5/029—Measuring blood output from the heart, e.g. minute volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6869—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
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    • A61B8/06—Measuring blood flow
    • A61B8/065—Measuring blood flow to determine blood output from the heart
    • A—HUMAN NECESSITIES
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    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
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    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/523—Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0883—Clinical applications for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • 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
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation

Definitions

  • the invention relates to a method for determining a flow velocity of a fluid flowing through an implanted vascular support system, an implantable vascular support system, and use of an operating parameter of a turbomachine of an implanted vascular support system.
  • the invention finds particular application in (fully) implanted left heart assist systems (LVAD).
  • LVAD left heart assist systems
  • ultrasonic volumetric flow sensors can perform pulsed Doppler measurements or use the pulsed Doppler (English: Pulsed Wave Doppler, short: PWD) method. This requires only an ultrasound transducer element and allows a precise choice of the distance of the observation window from the ultrasound element.
  • the task of a cardiac support system is the promotion of blood.
  • Flerz time volume (FIZV, usually given in liters per minute) has a high clinical relevance.
  • the time-space volume relates in this case 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 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
  • An established method for determining the cardiac output (QHZV) in the clinical setting is the use of dilution procedures, all of which rely on a transcutaneously inserted catheter, and therefore only during cardiac surgery and subsequent ICU stay heart-time-volume Metering data.
  • Q a approaches zero, so that approximately Q p * QHZV holds.
  • the heart-time volume can be determined at least approximately via the pump volume flow.
  • 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 support system used, the correlated Q p are error-prone. To increase the measurement quality of the parameter Q p, it is therefore desirable to include a flow sensor.
  • a particularly suitable sensor method for determining flow velocities and thus also volume flows is ultrasound, in particular the Pulsed Wave Doppler method (PWD), since it requires only one bidirectional ultrasound transducer element and a precise choice of the spacing of the observation window in which the measured values are collected become. It is thus possible to carry out the flow velocity measurement in the region in which suitable flow conditions prevail.
  • PWD Pulsed Wave Doppler method
  • ultrasonic pulses are emitted at a fixed pulse repetition rate (PRF). If the flow velocity and flow direction are unknown, the PRF must exceed at least twice the maximum Doppler frequency shift so as not to violate the Nyquist theorem. If this condition is not met, aliasing occurs, ie. H. Double meanings in the given frequency spectrum. When a frequency is detected in the frequency spectrum, it can no longer be uniquely assigned to one but several flow velocities.
  • PRF pulse repetition rate
  • the measurement range or the observation window may be so far away from the ultrasound transducer that the signal transit time of the ultrasound pulse from the transducer to the measurement area and back to the transducer can not be neglected. Since a new ultrasonic pulse may only be transmitted if the preceding one no longer delivers significant echoes, the signal propagation delay limits the maximum possible PRF. With the high flow velocities prevailing in Flerzunterstützungssystemen and the geometric boundary conditions for the removal of the observation window from the ultrasonic element, it inevitably leads to a violation of the Nyquist sampling theorem resulting in double ambiguities in the spectrum.
  • Flarzunterstützungssysteme with ultrasonic sensors which do not use the PWD method, are usually equipped with two ultrasonic transducers, so that the described runtime problem may indeed occur, but can be otherwise resolved by appropriate implementation.
  • heart assist systems with ultrasonic sensors that use the PWD method are susceptible to the described effect, especially for medium to high flow velocities.
  • the state of the art is currently the The requirement is to select the specified pulse repetition rate so that aliasing does not occur or to adjust both the geometric conditions and the ultrasonic frequency if possible.
  • the object of the invention is to specify an improved method for determining a flow velocity of a fluid flowing through an implanted vascular support system and to provide an improved implantable vascular support system in which the flow velocity of a fluid flowing therethrough is determined can.
  • a method for determining at least one flow velocity or a fluid volume flow of a fluid flowing through an implanted vascular support system comprising the following steps: a) performing a pulsed Doppler measurement by means of an ultrasound sensor of the support system,
  • step b) evaluating a measurement result from step a), which has a possible ambiguity
  • the vascular support system is preferably a cardiac support system, more preferably a ventricular assist system. Regularly, the support system serves to aid in the delivery of blood in the bloodstream of a human, and possibly patient.
  • the support system may be at least partially disposed in a 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.
  • the support system is preferably arranged at the exit of the left ventricle of the vein or the left ventricular chamber. Particularly preferably, the support system is arranged in aortic valve position.
  • the solution proposed here contributes to providing an aliasing compensation method for an ultrasonic volumetric flow sensor in a Flerzunterstützungssystem.
  • the method may be used for determining a fluid flow velocity and / or a fluid volume flow from a ventricle of a vein, in particular from a (left) ventricle of a heart to the aorta in the region of a (fully) implanted (left) ventricular (Cardiac) support system contribute.
  • the fluid is regularly looking for blood.
  • the flow velocity is determined in a fluid flow or fluid volume flow which flows through the support system, in particular through a (inlet) tube or a (inlet) cannula of the support system.
  • the method advantageously makes it possible for the flow velocity and / or the fluid volume flow of the blood flow to be determined outside the OP scenario with high quality, in particular by the implanted support system itself.
  • the fact can be used in a particularly advantageous manner that due to the engine map a rough estimate of the pump flow (only) from the rate of rotation of the drive or based on the differential pressure across the turbomachine and the yaw rate is possible.
  • the particularly rough estimation of the flow rate from the operating parameters of the turbomachine is used in particular to resolve the ambiguities in the spectrum and to enable a highly accurate flow measurement by the ultrasonic sensor.
  • a pulsed Doppler measurement is performed by means of an ultrasonic sensor of the support system.
  • the pulsed Doppler In particular the pulsed Doppler (English: Pulsed Wave Doppler (PWD short) method is used.
  • PWD short Pulsed Wave Doppler
  • a PWD measurement cycle is run through in step a).
  • step b) a measurement result from step a) is evaluated, which has a possible ambiguity.
  • possible ambiguity means, in particular, that the measurement result or all measurement results do not necessarily always have to have ambiguity ,
  • the measurement result usually has an ambiguity on.
  • a comparatively low flow velocity it can also occur that the measurement result is unambiguous.
  • the measurement result can be provided in particular after step b).
  • the measurement result may be, for example, as raw data (eg frequency spectrum) or as raw measurement result or as already partially processed pre-processed measurement result (eg as a (measured) flow velocity and / or as a (measured) fluid velocity). Volume flow).
  • the measurement result can be provided, for example, to a processing unit of the support system.
  • step c) provision is made of at least one operating parameter of a turbomachine of the support system.
  • the operating parameter may, for example, be provided to a processing unit of the support system.
  • the measurement result provided in step b) and the operating parameter provided in step c) are basically detected with respect to the same fluid flow, approximately in the same (temporal and / or spatial) observation window. In other words, this means in particular that the measurement result provided in step b) and the operating parameter provided in step c) relate to substantially the same measurement time or have substantially the same time stamp and / or refer to the same measurement location. "Substantially" describes in particular a deviation of less than one second.
  • a time difference (amounting to less than a second in general) can be taken into account until the operating parameter (or a change thereof) has an effect on the measuring location.
  • the measurement result provided in step b) and the operating parameter provided in step c) are associated with one another.
  • at least one operating parameter associated with the measurement result provided in step b) is preferably provided.
  • the (actual) flow velocity is determined using the measurement result evaluated in step b). If a raw-material result is evaluated in step b) and subsequently provided, it is particularly advantageous if a (measured) flow rate is determined therefrom (eg in step d).
  • step b If a measurement result preprocessed to one (measured) flow rate is provided in step b), this can advantageously be used directly in step d).
  • the (measured) flow rate is usually not clear.
  • an estimated flow velocity is determined on the basis of the operating parameter provided in step c). The (actual) flow velocity can now be determined, for example, by selecting the measured flow velocity which is closest to the estimated flow velocity.
  • an (actual) fluid volume flow can be determined in step d) (instead of the flow velocity). If a raw result is provided in step b), it is particularly advantageous if a (measured) fluid volume flow is determined therefrom. If in step b) a pre-processed to a (measured) fluid flow rate measurement result is provided, this can advantageously be used directly in step d). The (measured) fluid volume flow is usually not unique. Furthermore, it is advantageous if an estimated fluid volume flow is determined on the basis of the operating parameter provided in step c). The (actual) fluid volume flow can now be determined, for example, by selecting the measured fluid volume flow which is closest to the estimated fluid volume flow.
  • the possible ambiguity of the measurement result is corrected or resolved using the operating parameter.
  • the measurement result is usually ambiguous.
  • This Ambiguity can be explained in particular by the violation of the Nyquist sampling theorem, which is usually the case here.
  • This violation of the Nyquist sampling theorem is caused, in particular, by comparatively long signal propagation times in the support system between the ultrasound sensor and the observation window or measuring range, and in the case of pulsed Doppler measurements a new ultrasound pulse is usually sent out first , When the echo of an ultrasound pulse emitted immediately before has been received or has subsided.
  • the correction or the resolution of the possible ambiguity can, for example, in step d).
  • determination of the flow velocity can take place using the (possibly ambiguous) measurement result evaluated and / or provided in step b) and the operating parameter provided in step c), the possible ambiguity of the measurement result being used of the operating parameter is corrected.
  • the measured flow velocity or the measured fluid volume flow which is closest to the estimated flow velocity or the estimated fluid volume flow is selected.
  • the correction or the resolution of the possible ambiguity can take place, for example, (already) in step b).
  • This alternative may also be referred to as a priori estimation or as a priori selection or preselection.
  • This can be done particularly advantageously in such a way that (only) the area or section of the (raw) measurement result is evaluated, in which a plausible result is to be expected.
  • the evaluated (no longer ambiguous) Measurement result can be provided.
  • the evaluated (no longer ambiguous) measurement result can be used in this case.
  • a priori here means in particular that the operating parameter is provided and / or the estimated flow velocity or the estimated fluid volume flow is determined before the (potentially ambiguous) measurement result is evaluated (and possibly provided).
  • the operating parameter, the a priori estimated flow rate and / or the a priori estimated fluid volume flow contribute to a preselection to evaluate only a plausible measurement result or only the plausible part of the measurement result and / or to provide.
  • a (reflected and then) received ultrasonic pulse can only be evaluated in the (frequency) section in which a plausible result is to be expected.
  • a new ultrasound pulse be transmitted only when an echo of an ultrasound pulse emitted immediately before has subsided and / or has been received.
  • a new ultrasound pulse is emitted only when all (significant) echoes of an ultrasound pulse emitted immediately before have subsided (sufficiently) and / or have been received.
  • a new ultrasound pulse is preferably transmitted only when the (significant) echoes of an ultrasound pulse emitted immediately before out of a (predefined) measurement window or measuring range (sufficient) have decayed and / or received.
  • a maximum pulse repetition rate of the pulsed Doppler measurement is less than twice the maximum occurring Doppler shift.
  • the maximum pulse repetition rate of the pulsed Doppler measurements is smaller than the maximum occurring or expected Doppler shift.
  • the maximum pulse repetition rate is less than twice the maximum occurring Doppler shift is basically a violation of the Nyquist sampling theorem.
  • this injury may be required to perform a PWD procedure in a vascular support system.
  • the operating parameter is at least one rotational speed, a current, a power or a pressure.
  • the operating parameter is preferably a rotational speed (or rate of rotation) of the turbomachine, for example a drive (for example an electric motor) and / or a paddle wheel of the turbomachine.
  • the at least one operating parameter comprises a rotational speed of the turbomachine and a differential pressure across the turbomachine.
  • At least one estimated flow velocity or an estimated fluid volume flow be determined with the operating parameter. This can be done, for example, using a characteristic map in which the estimated flow velocity or the estimated fluid volume flow is stored as a function of the at least one operating parameter.
  • the operating parameter (a priori) be used to determine a plausible range in which plausible measurement results can lie.
  • a window function or windowing can be used in the frequency analysis (eg by means of discrete Fourier transformation) of the (reflected and then) received ultrasonic pulse.
  • a so-called Hamming window is used.
  • the fenestration, in particular the Hamming window can advantageously be dependent on the operating parameter and / or on the expected (and / or estimated) flow velocity and on the basis of the operating parameter Fluid volume flow are formed.
  • this relates to a fluid volume flow which flows through the support system itself (for example), for example through a (inlet) tube or a (inlet) cannula of the support system.
  • This fluid volume flow is usually the so-called pump volume flow (Q p ), which only quantifies the flow through the support system itself. If this value is known in addition to the total volume flow or time-volume (QHZV), the so-called degree of support can be calculated from the ratio of Q p to QHZV (ie Q P / QHZV).
  • the determined flow velocity can be multiplied, for example, by a flow-through cross section of the support system, in particular a tube or cannula cross section through which it is possible to flow.
  • an implantable vascular support system comprising:
  • a processing unit configured to correct a possible ambiguity of a measurement result of the ultrasonic sensor using the operating parameter of the turbomachine.
  • the support system is preferably a left ventricular vein assist system (LVAD) or a percutaneous, minimally invasive left ventricular assist system. Furthermore, this is preferably fully implantable. In other words, this means, in particular, that the means required for detection, in particular the ultrasound sensor, are located completely in the body of the patient and remain there.
  • the support system can also be divided in several parts or with several be arranged from one another components, so that, for example, the ultrasonic sensor and the processing unit (measuring unit) can be separated by a cable from each other.
  • the processing unit arranged separately from the ultrasound sensor can also be implanted or else arranged outside the patient's body.
  • the processing unit it is not absolutely necessary for the processing unit to be arranged in the body of the patient as well.
  • the support system may be implanted such that the processing unit is placed on the skin of the patient or outside the patient's body and a connection is made to the ultrasound sensor disposed in the body.
  • 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 support system comprises a tube (or a cannula), in particular inlet tube or inlet cannula, a flow machine, such as a pump and / or an electric motor.
  • the electric motor is a regular part of the turbomachine.
  • the (inflow) tube or the (inflow) cannula is preferably set up so that, when implanted, it can deliver fluid from a (left) ventricle of a heart to the turbomachine.
  • the support system is preferably elongate and / or tubular.
  • the tube (or the cannula) and the turbomachine are arranged in the region of opposite ends of the support system.
  • the ultrasonic sensor preferably has exactly or only one ultrasonic transducer element. This is particularly sufficient for a Doppler measurement, if the PWD method is used.
  • the turbomachine is preferably designed at least in the manner of a pump or an axial or radial compressor
  • the turbomachine can provide at least one of its (current) operating parameters of the processing unit provided, for example, controls or regulates at least one speed or a power of the turbomachine in dependence on (among others) a flow rate determined by way of example by the processing unit.
  • the support system is preferably set up to carry out a method proposed here.
  • a use of an operating parameter of a turbomachine of an implanted vascular support system for correcting a possible ambiguity of a measurement result of an ultrasound sensor of the support system is proposed.
  • at least one method proposed here or a support system proposed here for correcting a possible multiple use of a measurement result of an ultrasound sensor is used.
  • FIG. 2 shows the support system according to FIG. 1 implanted in a heart
  • FIG. 3 shows another implantable vascular support system
  • FIG. 4 shows the support system according to FIG. 3, implanted in a heart
  • the vascular support system is preferably a ventricular and / or cardiac support system or cardiac assist system.
  • cardiac assist systems Two particularly advantageous forms of cardiac assist systems are systems placed in the aorta according to FIG. 2 and apically placed systems according to FIG. 4. The respective systems are explained in more detail in connection with FIG. 1 (arotal) and FIG. 3 (apical).
  • FIG. 1 schematically shows an implantable, vascular support system 1.
  • FIG. 1 illustrates an embodiment of an aortic placed (see Fig. 2) or placeable support system.
  • the support system 1 comprises an ultrasound sensor 2, configured to perform a pulsed Doppler measurement, a turbomachine 3 and a processing unit 6, designed to correct a possible ambiguity of a measurement result of the ultrasound sensor 2 using the operating parameter of the turbomachine 3.
  • the ultrasound sensor 2 has, by way of example, exactly one ultrasound (transducer) element 19.
  • the support system 1 according to FIG. 1 further comprises by way of example here a distal part with inlet openings 7, through which the blood can be sucked into the interior of the system, and an inlet tube 8 (which in the aortic embodiment according to FIG Type of inlet cannula is formed).
  • the turbomachine 3 is equipped with an impeller 9 by way of example.
  • a supply cable 10 is placed here by way of example.
  • outlet openings 1 In the region of the impeller 9 are still outlet openings 1 1, through which the blood can be discharged.
  • a fluid volume flow 5 which enters the support system 1 via the inlet openings 7 and exits via the outlet openings 11, flows through the inlet pipe 8.
  • This fluid volume flow 5 can also be referred to as so-called pump volumetric flow.
  • FIG. 2 schematically shows the support system 1 according to FIG. 1, implanted in a wing 15.
  • the reference signs are used uniformly, so that reference can be made to the above statements.
  • the inlet openings 7 are in the implanted state, for example in the region of the ventricle 12, while the outlet openings are in the implanted state in the region of the aorta 13.
  • This orientation of the support system 1 is merely exemplary here and not mandatory, but rather the support system can be oriented in the opposite direction, for example.
  • the system is further exemplified implanted here so that it the aortic valve 14 passes. Such an arrangement may also be referred to as so-called aortic valve position.
  • FIG. 3 schematically shows another implantable, vascular support system 1.
  • 3 illustrates an embodiment of an api cal placed (see Fig .. 4) or placeable support system.
  • the functionality of an apically implanted system is basically comparable, so that uniform reference symbols can be used for all components. Therefore, reference is made here to the above statements to Fig. 1 reference.
  • FIG. 4 schematically shows the support system 1 according to FIG. 3, implanted in a wing 15.
  • the reference symbols are used uniformly, so that reference can also be made here to the above statements.
  • FIG. 5 schematically shows an exemplary illustration of a double measurement.
  • the ultrasonic sensor 2 of the support system 1 according to FIG. 1 is used by way of example in order to carry out a measurement in a supply pipe 8 of the support system 1 according to FIG.
  • the measuring window also referred to as an observation window and / or measuring area, for the ultrasound measurement is identified in FIGS. 1, 3 and 5 by reference numeral 16.
  • the choice of the measuring window 16 depends on the specific design of the (cardiac) support system 1 and should in principle be placed where suitable flow conditions prevail.
  • Fig. 5 shows a simplified sectional view of the dista len end of the embodiment of FIG. 1st
  • no parallel flow lines prevail on the left of the measuring window 16 in the region 17.
  • the Doppler effect also depends on the cos (a) between the main beam direction of the ultrasonic transducer and the main flow direction, it is advantageous to measure in a range of parallel flow lines.
  • a measuring window placed too far away eg area 18 is in principle possible, but may exacerbate the aliasing effect explained below and / or provide for a strong attenuation of the ultrasonic signal.
  • the ultrasonic sensor 2 is set up to perform a pulsed Doppler measurement.
  • pulsed wave doppler PWD
  • PWD pulsed wave doppler
  • the ultrasonic sensor 2 and the processing unit 6 can therefore also be referred to below as the so-called PWD system.
  • the measuring window 16 is typically electronically selectable in the PWD system, so that a statement about the flow conditions in different areas of the flow guidance can be made in an advantageous manner by measuring windows 16 of different depths.
  • the blood flows in the opposite direction towards the ultrasound element 19.
  • the rotating impeller 9 is located between the ultrasound element 19 and the inlet tube 8.
  • strong turbulences in the blood flow are to be expected, so that it is particularly advantageous to place the measuring window 16 in front of the impeller 9, approximately in the region of the inlet tube 8 ,
  • Fig. 6 shows schematically a flow of a method presented here in a regular operation.
  • the method is used for determining at least one flow velocity or a fluid volume flow of a fluid flowing through an implanted, vascular support system 1 (see Figures 1 to 5).
  • the illustrated sequence of method steps a), b), c) and d) with the blocks 1 10, 120, 130 and 140 is merely exemplary.
  • a pulsed Doppler measurement is performed by means of an ultrasonic sensor 2 of the support system 1.
  • a measurement result from step a) is evaluated, which has a possible ambiguity.
  • provision is made of at least one operating parameter of a turbomachine 3 of the support system 1.
  • determination of at least the flow velocity or the fluid volume flow takes place using the measurement result evaluated in step b). In the method, the possible multipathiness of the measurement result is corrected using the operating parameter.
  • An ultrasonic pulse is emitted at the ultrasonic element 19 and propagates in the direction of the measuring window 16.
  • the PWD system switches over to receive direction and receives the components which are scattered back continuously, for example on scattering bodies in the blood.
  • the duration of the pulse from the ultrasonic element to the measuring window and from the measuring window to the ultrasonic element is considered. In the case shown, the total relevant propagation distance is therefore 55.13 mm long (ultrasound element 19 until start of measurement window 16 plus burst length x 2).
  • the pulse duration limits the maximum pulse repetition rate to 27.93 kFlz.
  • Flangegen is the maximum Doppler shift 59.53 kFlz that occurs in the illustrated case. In a complex-valued evaluation (IQ demodulation), this leads to a minimum pulse repetition rate of 59.53 kFlz, at which the present Doppler shift can be interpreted without ambiguity. However, since the measurement is carried out with a maximum of 27.93 kFlz (maximum pulse repetition rate, see above), here the Nyquist sampling theorem is violated and ambiguities in the resulting Doppler spectrum are usually the result. These ambiguities are resolved here using an operating parameter of the turbomachine of the support system in order to be able to make a clear statement about the main flow velocity in the observation window.
  • Fig. 7 shows schematically an exemplary Doppler frequency spectrum. A schematic representation of the above-described relationship in the frequency spectrum is shown below. A corresponding representation of the described relationships is also illustrated in FIG. 8.
  • FIG. 7 shows the amplitude 32 of the Doppler signal over the (averaged) frequency 33 at fixed pulse repetition rate 34 (PRF).
  • the (fixed) pulse repetition rate 34 is 27 kFlz in the example considered here by way of example.
  • Shown in FIG. 7 are simplified spectra for different flow velocities of the fluid (here: the blood).
  • a first flow velocity 20 is smaller than a second flow velocity 21, which in turn is smaller than a third flow velocity 22, which in turn is smaller than a fourth flow velocity 23, which in turn is less than a fifth flow velocity 24.
  • the third flow velocity 22 already causes a violation of the Nyquist theorem, ie the Doppler frequency in the range of the pulse repetition rate (PRF, here by way of example 27 kFIz).
  • PRF pulse repetition rate
  • Flierzu can in principle already contribute a comparatively rough estimation of the range, since the ultrasound method still works with high precision (resolution to 1 -2 decimal places of the flow velocity in meters / second or the volume flow in liters / minute), but ambiguity over some Meter / second or liter / minute large area is present.
  • closureut 1540 m / s and windowing (window function ) with a so-called Hamming window 25.
  • the figure shows the frequency response at the following flow velocities:
  • Second flow rate 21 +1 m / s
  • a negative speed in this context means blood flowing to the ultrasound element and shows itself in a frequency shift with a positive sign.
  • This approximate velocity interval v, nt (plausible flow velocity range) can be resolved using the following formula after a corresponding Doppler shift or Doppler shift interval fdjnt.
  • the corresponding Doppler shift interval is 31.95 kFIz to 35.84 kFIz.
  • the determined frequencies which can not be represented can be converted into the representable frequency range with the following formula (for positive flow speeds).
  • the frequency interval predictable by the operating parameter therefore includes all frequencies between -9.95 kFIz and -6.05 kHz. All frequencies measured in this interval correspond to speeds in the range of 4.1 m / s to 4.6 m / s.
  • the exact velocity can be determined by calculating from the number of spectral "wraps" using the operating parameter interval (frequency interval predictable by the operating parameter) and successively recalculating with the formulas already shown from the measured frequency.
  • the term "wrap” refers to the jump of a signal from the largest positive representable frequency (fp RF / 2) to the largest representable negative frequency (-fp RF / 2).
  • Fig. 9 shows schematically a functional illustration of a possible embodiment of the method presented here.
  • the method according to the illustration according to FIG. 9 is used to resolve the ambiguities.
  • a PWD volumetric flow measurement 26 and an engine map-based volumetric flow measurement 27 take place.
  • the PWD volumetric flow measurement 26 can be carried out, for example, during step a).
  • the engine map-based volume flow measurement 27 can be performed, for example, between steps c) and d) or during step d).
  • the PWD volumetric flow measurement 26 here supplies a Doppler spectrum 28. This can be done, for example, during step b).
  • the engine map-based volumetric flow measurement 27 provides an estimated (coarse) volumetric flow rate 4.
  • the Doppler spectrum 28 and the estimated fluid volume flow 4 are sent to an anti-aliasing unit 29.
  • the anti-aliasing unit 29 determines from the estimated fluid volume flow 4 the (plausible) range in which the (actual) flow rate is located and from the Doppler spectrum 28 and the (plausible) volume flow range the corrected flow rate 30 , which is also referred to herein as (actual) flow rate through the support system.
  • the anti-aliasing unit 29 may for example be part of the processing unit also described here.
  • a volume flow calculation unit 31 combines the known cross-sectional geometry and the known flow profile, which are determined in dependence on the type of construction and flow rate, on the (actual) fluid volume flow 5.
  • the PWD volumetric flow measurement 26 can comprise the following steps:
  • the generated data can be temporarily stored in a memory for later evaluation or (eg in case of parallel implementation in programmable logic) directly processed further.
  • a demodulation of the received echo sequence with the known ultrasound pulse frequency (“downmixing into the baseband") generally takes place.
  • a transformation of the acquired baseband signal into the frequency domain takes place (Transformation from time to frequency domain to calculate the Doppler spectrum).
  • the engine map-based volume flow measurement 27 may include the following steps:
  • a pump operating parameter such as rotation rate (revolutions per minute, RPM for short), power consumption, current consumption and / or pressure difference across the flow machine (eg pump),
  • the volume flow calculation unit 31 carries out, for example, the following: multiplication of the known cross section in the region of the observation window 16 (symbol: A), with the flow velocity 30 (symbol: v), and a flow velocity-dependent flow profile correction parameter (symbol f (v)) ,
  • the (actual) fluid volume flow (formula character Q p ) can be given by the following formula:
  • the anti-aliasing unit 29 and the volume flow calculating unit 31 may also be combined into one unit.
  • the Doppler spectrum can be mapped directly to the volume flow Q p .

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PCT/EP2019/064807 2018-06-06 2019-06-06 Verfahren zur bestimmung einer strömungsgeschwindigkeit eines durch ein implantiertes, vaskuläres unterstützungssystem strömenden fluids und implantierbares, vaskuläres unterstützungssystem Ceased WO2019234166A1 (de)

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AU2019282300A AU2019282300B2 (en) 2018-06-06 2019-06-06 Method for determining a flow speed of a fluid flowing through an implanted, vascular assistance system and implantable, vascular assistance system
ES19729729T ES2975238T3 (es) 2018-06-06 2019-06-06 Procedimiento para determinar una velocidad de flujo de un fluido que fluye a través de un sistema de asistencia vascular implantado y sistema de asistencia vascular implantable
CA3105919A CA3105919C (en) 2018-06-06 2019-06-06 Method for determining a flow velocity of a fluid flowing through an implanted vascular support system and implantable vascular support system
CN201980048728.2A CN112566687B (zh) 2018-06-06 2019-06-06 用于确定流过植入式血管辅助系统的流体的流速的方法以及可植入式血管辅助系统
EP19729729.4A EP3801668B1 (de) 2018-06-06 2019-06-06 Verfahren zur bestimmung einer strömungsgeschwindigkeit eines durch ein implantiertes, vaskuläres unterstützungssystem strömenden fluids und implantierbares, vaskuläres unterstützungssystem
US15/734,523 US12310708B2 (en) 2018-06-06 2019-06-06 Systems and methods for determining a flow speed of a fluid flowing through a cardiac assist device
JP2020567982A JP7269667B2 (ja) 2018-06-06 2019-06-06 埋め込まれた血管補助システム、および埋め込み可能な血管補助システムを流れる流体の流速を決定する方法
US19/218,061 US20250281060A1 (en) 2018-06-06 2025-05-23 Systems and methods for determining a flow speed of a fluid flowing through a cardiac assist device

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DE102018208933A1 (de) 2019-12-12
CN112566687B (zh) 2024-08-16
CN112566687A (zh) 2021-03-26
ES2975238T3 (es) 2024-07-04
US20220039669A1 (en) 2022-02-10
JP2021526892A (ja) 2021-10-11

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