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WO2024242960A9 - Calcul de paramètre d'une pompe d'assistance circulatoire - Google Patents

Calcul de paramètre d'une pompe d'assistance circulatoire

Info

Publication number
WO2024242960A9
WO2024242960A9 PCT/US2024/029438 US2024029438W WO2024242960A9 WO 2024242960 A9 WO2024242960 A9 WO 2024242960A9 US 2024029438 W US2024029438 W US 2024029438W WO 2024242960 A9 WO2024242960 A9 WO 2024242960A9
Authority
WO
WIPO (PCT)
Prior art keywords
impeller
parameter
bearing
heart pump
indicator
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.)
Pending
Application number
PCT/US2024/029438
Other languages
English (en)
Other versions
WO2024242960A1 (fr
Inventor
Nicholas Greatrex
Daniel Timms
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bivacor Inc
Original Assignee
Bivacor Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bivacor Inc filed Critical Bivacor Inc
Priority to AU2024274773A priority Critical patent/AU2024274773A1/en
Publication of WO2024242960A1 publication Critical patent/WO2024242960A1/fr
Publication of WO2024242960A9 publication Critical patent/WO2024242960A9/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A61M60/183—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
    • A61M60/232—Centrifugal pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—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
    • A61M60/814—Volutes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A61M60/816—Sensors arranged on or in the housing, e.g. ultrasound flow sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A61M60/82—Magnetic bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A61M60/82—Magnetic bearings
    • A61M60/822—Magnetic bearings specially adapted for being actively controlled

Definitions

  • US-8,636,638 describes a controller for a heart pump that determines movement of an impeller within a cavity in a first axial direction, the cavity including at least one inlet and at least one outlet, and the impeller including vanes for urging fluid from the inlet to the outlet, causing a magnetic bearing to move the impeller in a second axial direction opposite the first axial direction, the magnetic bearing including at least one coil for controlling an axial position of the impeller within the cavity, determining an indicator indicative of the power used by the magnetic bearing and causing the magnetic bearing to control the axial position of the impeller in accordance with the indicator to thereby control a fluid flow between the inlet and the outlet.
  • the method includes magnetically rotating an impeller within a blood flow channel of a blood pump.
  • the impeller is levitated within the blood flow channel transverse to the impeller axis of rotation.
  • a rotational speed for the impeller is determined.
  • At least one impeller transverse position parameter is determined.
  • the at least one impeller transverse position parameter is based on at least one of (1) an amount of a bearing current that is used to levitate the impeller transverse to the impeller axis of rotation, and (2) a position of the impeller within the blood flow channel transverse to the impeller axis of rotation.
  • a flow rate of blood pumped by the blood pump is estimated based on the impeller rotational speed and the at least one impeller transverse position parameter.
  • the method includes: (a) driving the rotor using the motor, so as to circulate fluid from the first impeller through a first fluid circuit, the second impeller, a second fluid circuit, and back to the first impeller; (b) determining a resistance of the first fluid circuit, based on a first motor parameter; (c) determining a flow rate through the first fluid circuit based on a second motor parameter; and (d) varying at least one operational parameter of the pump so as to maintain a predetermined relationship between the flow rate and the resistance of the first fluid circuit. [0017]
  • this approach only uses the motor speed and power to calculate systemic and vascular resistances.
  • the drive indicator is indicative of at least one of: a current supplied to the drive; an expected rotational speed of the impeller; an actual rotational speed of the impeller; and, a magnitude of a rotational speed change of the impeller; a waveform of changes in rotational speed of the of the impeller; and, a ratio of high speed and low speed periods of the waveform.
  • the one or more processing devices are configured to determine the drive indicator based on a magnitude of current signals applied to the drive.
  • the one or more processing devices are configured to: determine at least one clinically measured pressure parameter; and, calculate remaining absolute pressure parameters, wherein the pressure parameters include: central venous pressure (CVP); left atrial pressure (LAP); pulmonary aterial pressure (PAP); and, aortic pressure (AoP).
  • the one or more processing devices are configured to at least one of: control the heart pump at least in part using the at least one parameter; display an indication of the at least one parameter; record, to non-transitory memory, an indication of the at least one parameter; and, generate an alert or notification based on at least one parameter.
  • the one or more processing devices are configured to: determine a waveform shape of signals within at least one of a drive indicator and the bearing indicator; and, determine the parameter using the waveform shape.
  • the one or more processing devices are configured to: identify parts of the subject's cardiac cycle using the waveform shape; and, determine the parameter using the parts of the cardiac cycle.
  • the impeller includes first and second sets of vanes provided on a rotor body, the rotor being positioned within the cavity to define: a first cavity portion having a first inlet and a first outlet, the first set of vanes being provided within the first cavity portion so as to define a first pump that provides at least partial left ventricular function; and, a second cavity portion having a second inlet and a second outlet, the second set of vanes being provided within the second cavity portion so as to define a second pump that provides at least partial right ventricular function.
  • the axial position of the impeller determines a separation between each set of vanes and a respective cavity surface, the separation being used to control the fluid flows from the inlets to the outlets.
  • the drive is positioned at a first end of the cavity and the magnetic bearing is positioned at a second end of the cavity.
  • the heart pump is at least one of: a ventricular assist device; and, a total artificial heart.
  • the one or more processing devices are configured to: determine a waveform shape of signals within at least one of a drive indicator and the bearing indicator; and, determine the parameter using the waveform shape.
  • the one or more processing devices are configured to: identify parts of the cardiac cycle using the waveform shape; and, determine the parameter using the parts of the cardiac cycle.
  • the parameter includes at least one of: a subject parameter; a pump operating parameter; and, a hemodynamic parameter.
  • the subject parameter includes at least one of: a breathing rate; a breathing depth; and, at least one hemodynamic parameter, the at least one hemodynamic parameter including at least one of: vascular compliance; an atrial contractility magnitude; and, an atrial contractility rate.
  • the one or more processing devices are configured to at least one of: control the heart pump at least in part using the at least one parameter; display an indication of the at least one parameter; record an indication of the at least one parameter; and, generate an alert or notification based on the at least one parameter.
  • a controller for a heart pump wherein the heart pump includes: a housing forming a cavity including at least one inlet and at least one outlet; an impeller provided within the cavity, the impeller including vanes for urging fluid from the inlet to the outlet upon rotation of the impeller; a drive that rotates the impeller within the cavity; a magnetic bearing including at least one bearing coil that controls an axial position of the impeller within the cavity; and, wherein the controller includes one or more one or more electronic processing devices that are configured to: determine a drive indicator indicative of rotation of the impeller; and, use the drive indicator to calculate at least one parameter.
  • an aspect of the present invention seeks to provide a method performed using one or more processing devices coupled to a heart pump of a patient, the method including: determining a drive indicator associated with a drive that includes at least one drive coil that rotates an impeller within a cavity of the heart pump; and, using the drive indicator to calculate at least one parameter.
  • the indicator includes a drive indicator indicative of rotation of the impeller.
  • the method further includes: comparing the at least one parameter to a defined threshold; and, wherein adjustment of treatment is further based on the comparing.
  • the at least one parameter includes a subject parameter.
  • the subject parameter includes a hemodynamic parameter.
  • the at least one parameter includes an operating parameter for the heart pump.
  • adjusting the treatment includes controlling operation of the heart pump based on the calculated at least one parameter.
  • the method further includes: outputting, to a display screen, a display that includes an indication of the at least one parameter, wherein adjusting of treatment is based on the indication of the at least one parameter that is displayed. [0074] In one embodiment the method further includes: storing, to non-transitory memory, an indication of the at least one parameter, wherein adjusting of treatment is based on the stored indication. [0075] In one embodiment the method further includes: generating an alert or notification based on the at least one parameter, wherein adjusting of treatment is based on the alert or notification. [0076] It will be appreciated that the broad forms of the invention and their respective features can be used in conjunction and/or independently, and reference to separate broad forms is not intended to be limiting.
  • Figure 1A is a schematic perspective view of an example of a heart pump
  • Figure 1B is a schematic cutaway view of the heart pump of Figure 1A
  • Figure 1C is a schematic perspective exploded view of the heart pump of Figure 1A
  • Figure 1D is a schematic diagram of an example of a control system for the heart pump of Figure 1A
  • Figure 2A is an example pump flow curve for a heart pump
  • Figure 2B is an example of pump pressure flow curves for a number of different heart pumps
  • Figure 3 is a schematic diagram of a specific example of a controller architecture
  • Figure 4 is a flow chart of an example of a process for
  • Figure 15 is a flow chart of an example of the process for calculating periodic subject parameters;
  • Figure 16A is a graph of an example of magnetic bearing current signals captured for a subject during a monitoring period;
  • Figure 16B is a graph of an example of impeller position captured for the subject during the monitoring period of Figure 16A;
  • Figure 16C is a graph of an example of vascular resistance for the subject during the monitoring period of Figure 16A;
  • Figure 16D is a graph of an example of pump inlet pressure differences captured for the subject during the monitoring period of Figure 16A;
  • Figure 17 is an example of a waterfall plot showing periodic subject parameters derived for the monitoring period of Figure 16; and, [0110]
  • Figure 18 is an example of a plot showing an increase in impeller vibration.
  • the heart pump is a biventricular device which can operate either as a ventricular assist device to assist function of left and right ventricles of a subject's heart, or alternatively as a total artificial heart. It will be appreciated however that whilst reference is made to a biventricular device this is not essential, and alternatively the control processes described herein could equally be applied to single ventricular assist devices or any form of blood pump.
  • the heart pump 100 includes a housing 110 defining a cavity 115.
  • the housing can be of any suitable form but typically includes a main body 110.1, left and right end caps 110.2, 110.3 which connect to the main body 110.1, as well as an end plate 110.4 positioned between the main body 110.1 and left end cap 110.2.
  • the housing can be made of any suitable biocompatible material, and can be made of titanium, a polymer or the like.
  • the housing 110 includes two inlets 111, 113, for connection to the pulmonary vein and vena cava, or left and right ventricles, and two outlets 112, 114 for connection to the aorta and pulmonary artery, respectively.
  • the heart pump 100 includes an impeller 120 provided within a cavity 115.
  • the impeller 120 includes a rotor 121 having vanes mounted thereon for urging fluid from the inlet to the outlet upon rotation of the impeller 120.
  • the impeller includes two sets of vanes 122, 123 each of which is used for urging fluid from a respective inlet 111, 113 to a respective outlet 112, 114.
  • the heart pump 100 further includes a drive 130 that rotates the impeller 120 within the cavity 115.
  • the drive 130 can be of any appropriate form but typically includes a number of coils 131 wound on a stator 132, supported by a mounting 133, allowing the drive 130 to be coupled to the housing 110.
  • the drive cooperates with magnetic material 134 mounted in the rotor 121 with this typically being in the form of a number of circumferentially spaced permanent magnets mounted in the rotor 121 proximate an outer circumferential edge of the rotor and proximate a face of the rotor facing the drive coils 131.
  • the coils 131 and stators 132 are wedge shaped and circumferentially spaced around the mounting 133, so as to provide twelve electromagnets radially aligned with circumferentially spaced drive magnets 134 in the rotor 121, to thereby maximise a degree of magnetic coupling between the magnets in the rotor 121 and the drive 130.
  • the drive magnets 134 are typically arcuate shaped rare earth magnets, circumferentially spaced proximate an outer circumferential edge of the rotor 121, and mounted on a soft iron rotor drive yoke.
  • the heart pump 100 can further include a magnetic bearing 140 including at least one bearing coil 141 which cooperates with bearing magnetic material mounted in the rotor 121 allowing to thereby control an axial position of the impeller 120 within the cavity 115.
  • the magnetic bearing includes three bearing coils 141, each of which is mounted on a first leg 142.1 of respective U-shaped stators 142, with a second leg 142.2 being positioned radially inwardly of the first leg 142.1.
  • the stators 142 are mounted to a support 143 and circumferentially spaced 120° apart around the housing so that the first and second legs 142.1, 142.2 align with respective magnetic material, such as bearing magnets 144, 145, optionally mounted on a common yoke (not shown) allowing an axial position of the impeller 120 to be controlled.
  • the bearing magnetic material typically includes first and second annular magnetic bearing members mounted within and proximate a face of the rotor facing the bearing coils 141, the first magnetic bearing member being provided radially outwardly of the second magnetic bearing member.
  • the first bearing magnet material 144 includes an annular soft iron material that can be integrally formed with the annular yoke, or an annular permanent magnet 144 mounted on the yoke, and mounted in the rotor, proximate an outer circumferential edge of the rotor 121.
  • the second bearing magnetic material is an annular permanent bearing magnet 145 mounted radially inwardly of the first bearing member 144, so that the first and second bearing members 144, 145 align with respective legs 142.1, 142.2 of the stators 142.
  • the annular members could include a plurality of individual elements, such as individual circumferentially spaced magnets or ferromagnetic elements.
  • the drive 130 and magnetic bearing 140 are mounted at opposing ends of the housing 110 so that the drive and bearing 130, 140 are provided proximate opposing surfaces of the rotor 121 as shown for example in Figure 1D.
  • the drive 130 is mounted adjacent the left pump, whilst the bearing 140 is mounted adjacent the right pump, although the opposite configuration is contemplated.
  • the depicted arrangement has a number of benefits.
  • the inherent attractive magnetic forces between the drive and rotor and the bearing and rotor can be configured to substantially balance when the rotor is provided at a balance point at a normal operating speed, which may for example by approximately at a center of the cavity under conditions of normal hemodynamic conditions.
  • this arrangement can be configured so that the magnetic forces inherent between the drive 130 and impeller 120, and between the magnetic bearing 140 and impeller 120 are matched at an impeller balance position within the cavity, which corresponds to a desired position of the impeller under conditions of normal flow. This minimises the bearing current required to maintain the position of the impeller 120 within the cavity, hence reducing the amount power required to operate, and in particular drive and axially position the impeller.
  • the forces generated by the drive and bearing can also be configured to provide a desired degree of axial and radial stiffness.
  • the stiffness is a measure of the deflection of the impeller 120 from a balance position in response to an external force. In one example, it is desirable to maximise the radial stiffness so as to maintain the impeller radially centralised within the cavity and to stop the impeller touching the inner circumferential wall of the cavity.
  • the axial position of the impeller 120 can be used for flow control, and in particular to allow for passive and/or active response to changes in hemodynamic parameters, a low degree of axial stiffness is preferred.
  • the apparatus further includes a controller 150 which, in use, is coupled to a sensor 160 and the drive and bearing coils 131, 141.
  • the sensor 160 senses an axial position of the impeller 120 within the cavity 115 and can be of appropriate form such as a reluctance or eddy current sensor, which detect magnetic fields within the rotor 121 to thereby determine a separation between the rotor and the sensor 160, as will be appreciated by persons skilled in the art. [0125] Typically three sensors would be provided circumferentially spaced around the rotor.
  • each sensor would typically include a coil mounted in a housing, circumferentially spaced and aligned with the inner second leg 142.2 of the magnetic bearing stators 142.
  • the coil is aligned with a rotor shell/target mounted radially inwardly of a first bearing magnet 144, so as to generate a field therein, with variations in the field being detected to determine the separation of the sensor 160 and the shell/target, and hence the rotor 121.
  • suitable sensors can be used, such as reluctance sensors or the like, in which case the first permanent magnet 144 might be replaced with ferromagnetic material, depending on the sensor/bearing requirements.
  • the controller 150 can be of any suitable form but typically includes an electronic processing device 151, an optional memory 152, and an interface 154 for connecting to the heart pump, each of which are interconnected by a bus 155, or other similar arrangement.
  • the electronic processing device can be any form of electronic processing device capable of interpreting signals and causing the drive and bearing to be controlled, such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement.
  • the system can use multiple processing devices, with the indicated processing being performed by any or all of the one or more of the processing devices.
  • references to a processing device or similar should be understood to encompass both a single processing device and multiple processing devices performing the described actions, operations, or the like , In the case of multiple processing devices, processing carried out by each instance of a processing device may be distributed as appropriate. Indeed, unless otherwise specified, reference to an electronic processing device (including one or more electronic processing devices) being configured to perform operations (and/or performing such operations) should be understood such that each performed action, operation, or the like, may be performed by any of the different electronic processing devices, the same electronic processing device, or any combination thereof.
  • one or more processing devices used for calculating parameters could be separate to the controller.
  • the system could include a controller with a first processing device and a second remote processing device, with calculation of parameters being performed by either processing device, or split between the processing devices as needed, or provided by a processing device that is separate from the controller.
  • the one processing device may be provided in the body of the subject (e.g., with an implanted heart pump) while a second processing device may be provided externally (e.g., on a mobile device, a bedside device, in a cloud computing environment, etc.).
  • An optional external interface 153 may be provided allowing for interaction with the controller 150.
  • the controller In the event that the controller is positioned outside the body this could include an I/O device 153 such as a touch screen, display, or the like, whereas if positioned inside the body this would typically be in the form of a wireless communications module allowing communication with an external control device, a processing system, such as a computer system, a client device, such as a smart phone, a patient monitoring system or similar.
  • a left ventricular assist device Typically, the mean flow of a left ventricular assist device (LVAD) is estimated based on a known relationship between the motor power and the pump flow for a given pump speed.
  • LVAD left ventricular assist device
  • FIG. 2A An example of this is shown in Figure 2A.
  • the pressure head can be estimated using a similar relationship, as shown in Figure 2B.
  • the viscosity of the working fluid can change the relationship between the motor power and output flow, so hematocrit needs to be considered in LVAD flow estimation.
  • estimation of flow is not necessarily accurate taking into account motor power and/or speed and haematocrit.
  • the pump flow curve undergoes an inflexion, meaning two different pump flows can be obtained for a given motor power, meaning there is ambiguity when calculating flow based on the motor speed. Additionally, such approaches will not work on dual sided impeller designs similar to those described above.
  • the processor 303 calculates the change in required impeller rotational speed, generating a drive control, which is provided to a drive controller 304, which controls the rotational speed of the impeller accordingly. Additionally, an optional drive signal modulator 305 can be provided to generate a modulating signal for modulating the rotational speed of the impeller with this being combined with the signal output from the processor 303 by suitable logic, an amplifier or the like, at 306. [0134] An example of an alternative approach for calculating parameters, and in one particular example, subject parameters such as hemodynamic parameters, will now be described with reference to Figure 4. [0135] For the purpose of illustration, it is also assumed that the process is performed at least in part using one or more electronic processing devices, optionally forming part of the controller 150.
  • the processing device operates to determine a drive indicator drive indicator at least partially indicative of rotation of the impeller, such as the power used by the drive 130 and/or the rotational speed of the impeller 120.
  • the processing device determines a bearing indicator relating to axial forces on the impeller.
  • the bearing indicator is typically at least partially indicative of operation of the magnetic bearing and can be indicative of an axial position of the impeller but more typically is indicative of a bearing power used by the magnetic bearing.
  • the bearing power indicator is typically indicative of, or derived from, the bearing current drawn by the magnetic bearing. However, it will be appreciated that this is not essential, and any suitable bearing indicator can be used.
  • the controller uses one or both of the drive indicator and the bearing indicator to determine one or more parameters.
  • the parameters can include subject parameters, such as hemodynamic parameters, including a head pressure, a relative inlet pressure, absolute pressures within a subject, a systemic vascular pressure or a pulmonary vascular pressure, a measure of delivered oxygen, or the like.
  • the subject parameters can be indicative of periodic events within the subject, such as a breathing rate, breathing depth, vascular compliance, atrial contraction, ventricular contractility (in the case of the VAD being an assist device), or the like.
  • this can involve analysing the bearing and/or drive indicator using a variety of signal processing techniques, including but not limited to performing spectral analysis, such as Fourier transforms, using linear equations (e.g. polynomials), or non-linear functions, and filtering, such as Kalman filtering, performing a convolution, cross correlation, or auto correlation, regression analysis, or the like.
  • spectral analysis such as Fourier transforms, using linear equations (e.g. polynomials), or non-linear functions
  • filtering such as Kalman filtering, performing a convolution, cross correlation, or auto correlation, regression analysis, or the like.
  • the controller is configured to determine a fluid viscosity indicator indicative of the viscosity of blood within the heart pump and use the drive indicator, the bearing indicator and the fluid viscosity indicator to calculate the at least one hemodynamic parameter. Further including the fluid viscosity in the calculation of hemodynamic parameters can lead to a further improvement in the accuracy of the calculation.
  • the fluid viscosity indicator can be determined based on user input commands, for example by having a clinician provide an indication of hematocrit (HCT), or can be determined by estimating the fluid viscosity. This can be achieved using known techniques, such as by using a plant transfer function and/or variations in the bearing indicator, as will be described in more detail below.
  • this information can be derived from other parameters, such as the breathing rate or depth, the pump flow rate, ventricular/ atrial contraction, or the like.
  • activity detection could be achieved by monitoring the bearing and/or drive indicators and identify patterns in the indicators, such as periodic events, which can in turn be used to identify activities, such as walking, running or the like.
  • a subject posture or subject posture change can be determined, for example using changes in bearing indicator to indicate a shift in physical posture, and/or using the bearing and/or drive indicators to determine a directional of a gravitational force on the impeller, which can in turn be indicative of a subject orientation. [0159] Having determined the one or more parameters, then the determined one or more parameters may then be used in various ways.
  • the calculated one or more parameters may be used by, for example, a clinician to adjust therapy / treatment that is provided to a subject.
  • adjusting therapy or treatment may include modifying operation of the pump (e.g., to pump less or more) and/or providing a recommendation/adjustment to an aspect of a subject’s lifestyle (e.g., to lower their level of exertion).
  • such adjustments may be delivered to / by the patient, clinician, or others and may be carried out manually or automatically (e.g., via adjusting the pump) in some examples.
  • the processing device of the controller 150 can control the pump based on the parameter.
  • the processing device can control a blood flow rate through the heart pump, adjusting this to meet physiological requirements of the subject as needed, for example increasing the flow rate when the subject is exercising or decreasing the flow rate when the subject is resting.
  • the physiological requirements can be determined from subject parameters, such as hemodynamic parameters, information regarding ventricular or atrial contractility, subject activity levels, or other parameters.
  • the processing device can vary the rotational speed to induce pulsatile flow, for example to produce a washout pulse to reduce stagnation within the pump and/or to vary the rotational speed to induce pulsatile flow that mimics a physiological pulse.
  • the processing device can determine the subject's physiological pulse based on parameters such as valve opening / closing or ventricular or atrial contractility, allowing the pump to match the cardiac cycle, to ensure optimum assistance is provided. Additionally, selectively loading a subject's heart can help promote recovery of the subject's heart.
  • the pump when operating the pump as a ventricular assist device, completely and continuously unloading the left ventricle means that the left ventricle muscle has minimal work to do and therefore wouldn't regenerate or recover.
  • the left ventricle is required to perform work, which can promote left ventricle recovery.
  • the pump can be operated to monitor left ventricle contractility, progressively increasing the magnitude or duration of load on the ventricle (by reducing pump flow) over time and/or when improvements in left ventricular contractility are detected.
  • the processing device can vary the rotational speed to induce pulsatile flow in accordance with a pulse waveform.
  • the pulse waveform will typically include peaks corresponding to higher operating speeds and troughs corresponding to lower operating speed, with these corresponding to periods of systolic and diastolic flow, respectively.
  • the rotational speed can be controlled to alter a pulse waveform of pulsatile flow, for example to alter a pulsatile frequency, alter a pulsatile magnitude and/or change a ratio of higher speed and lower speed parts of the pulse waveform.
  • the parameter that is determined may be displayed (e.g., on a display screen to a clinician) and/or recorded (e.g., for further follow-up).
  • the recorded and/or displayed information regarding the determined parameter may then be used by a clinician or other medical practitioner.
  • a clinician or other medical practitioner can review the determined parameters, such as hemodynamic parameters, and use these to: 1) monitor the subject. For example, to check that the subject is responding correctly to the heart pump, and the heart pump is working correctly, and the like.
  • a clinician or other medical practitioner can use any or all of the determined parameter(s) to make a clinical diagnosis for the subject or a therapy determination for the subject.
  • the parameter that is determined may be further processed and used to, for example, generate one or more alerts or notifications. Further processing of the parameter may be performed by comparing, using a processing device, the one or more parameters to reference ranges, thresholds, and/or the like. Ranges may represent expected values for the parameter in question. Thresholds may represent upper and lower bounds for such parameters. Generating an alert or notification can then be performed depending on results of the comparison.
  • the alert or notifications could be provided to the subject and/or a clinician, depending on the nature of the issue. For example, if it is determined the subject is over exerting themselves (e.g., based on determination of one or more parameters and comparison to a range or threshold), a notification could be presented to the subject informing them to reduce their physical activity. Alternatively, if it is determined the patient is responding adversely to current pump operation a clinician could be alerted.
  • the nature of the alert or notification could vary depending on the preferred implementation and the nature of any issue. For example, visual and/or audible indications could be provided via an input/output device of a controller, a message could be sent to a client device, such as a phone, computer system, or the like.
  • the controller 150 is configured to modify (e.g., based on determination of one or more parameters) the speed as a function of flow or pressure so that the rotational speed of the impeller is controlled to increase or decrease an effective pump flow curve gradient.
  • this can be used to increase or decrease the change in head pressure that is achieved for a change in flow rate, in turn provide a greater degree of control over the flow and pressures within the subject.
  • the processing device typically performs spectral analysis, such as a Fourier analysis of the drive indicator and/or bearing indicator and determines the at least one subject parameter using results of the analysis.
  • the processing device is configured to determine a magnitude and/or frequency of periodic signals within the drive indicator and/or bearing indicator, for example looking for periodic signals within the drive and/or bearing current. The magnitude and/or frequency of these signals can then be used to determine parameters.
  • the processing device can determine a waveform shape of signals within at least one of a drive indicator and the bearing indicator and then determine the parameter using the waveform shape.
  • this could involve detecting signal corresponding to the subject's heartbeat, and then identifying parts of the subject's cardiac cycle using the waveform shape so that these could be used to determine the parameter.
  • knowledge of the timing of diastole and systole can help identify events such as valve opening and/or closing, and/or to modify or set the speed of the pump to provide improved interaction between the native cardiac function and the heart pump.
  • the pump includes a single sided impeller configured to act as a VAD, as will be described in more detail below.
  • the impeller is a dual sided impeller similar to the example described above.
  • the impeller includes first and second sets of vanes provided on a rotor body, with the rotor being positioned within the cavity to define a first cavity portion having a first inlet and a first outlet, the first set of vanes being provided within the first cavity portion so as to define a first pump that provides at least partial left ventricular function and a second cavity portion having a second inlet and a second outlet, the second set of vanes being provided within the second cavity portion so as to define a second pump that provides at least partial right ventricular function.
  • an axial position of the impeller within the cavity determines a separation between each set of vanes and a respective cavity surface, the separation being used to control the fluid flows from the inlets to the outlets.
  • bronchial shunt is a physiological phenomena in which lung tissue is perfused with oxygenated blood from the systemic circulation that is then returned in part to the pulmonary veins/left atrium, in contrast to typical flow patterns where the oxygenated blood from the aorta is returned to the right atrium.
  • the bronchial shunt is another flow path that can be added into the above calculations, to thereby obtain more accurate pressure estimates.
  • the bronchial shunt is only 1% of the total blood flow, whereas in heart failure patients it can be as high as 4%.
  • the controller 150 operates to control the pump, based on the determined pressures. This can include adjusting the drive and/or bearing as required.
  • the controller is configured to predict head pressure, with an error being inputter as head pressure minus predicted head pressure. Proportional integral control is then used to control to a speed target, with autonomous changes to the speed would be limited to a defined safe range.
  • this can be used when one or two pumps are used to provide assistance or replacement of the left or right ventricles, including in a TAH, when two rotary pumps to provide complete replacement of the native heart, in an LVAD/RVAD, when a single rotary pump is used to provide assistance to either the left or right ventricles, or in a BiVAD, when two rotary pumps to provide assistance to both the left or right ventricles.
  • the controller and control process can be used in a device that uses an active magnetic bearing in conjunction with a zero power controller that controls the position of the rotor in response to a change of magnetic bearing current. Signal filtering techniques on the fundamental current signal with consideration to the zero power controller can return a feedback signal appropriate for use in the controller.
  • the heart pump 1400 includes a housing 1410 defining a cavity 1415.
  • the housing can be of any suitable form but typically includes a main body, and left and right end caps which connect to the main body.
  • the housing can be made of any suitable biocompatible material, and can be made of titanium, a polymer or the like.
  • the housing 1410 includes an inlet 1411, for connection to the left atrium/pulmonary vein or right atrium/vena cava, or left or right ventricle, and an outlet 1412 for connection to the aorta or pulmonary artery, respectively.
  • the heart pump 1400 includes an impeller 1420 provided within the cavity 1415.
  • the impeller 1420 includes a rotor 1421 having vanes 1422 mounted thereon for urging fluid from the inlet 1411 to the outlet 1412 upon rotation of the impeller 1420.
  • the impeller includes a single set of vanes 1422 for urging fluid from the inlet 1411 to the outlet 1412.
  • the vanes 1422 have a configuration similar to that described above, and these will not therefore be described in further detail, although it will be appreciated that other suitable vane configurations can be used.
  • the impeller can also include an aperture 1424 extending therethrough to allow blood to flow around the rear surface of the impeller and thereby prevent stagnation and clotting of blood within the heart pump. Furthermore, the use of a magnetic bearing in this region allows for blood gaps in excess of 200-300 ⁇ m, which can both reduces shear stress and thus red cell lysis, as well as promote greater rates of washout flow than otherwise anticipated in gaps created by hydrodynamic bearings.
  • the heart pump 1400 further includes a drive 1430 that rotates the impeller 1420 within the cavity 1415.
  • the drive 1430 can be of any appropriate form but typically includes a number of coils, each wound on a respective stator, supported by a mounting, allowing the drive 1430 to be coupled to the housing 1410.
  • the drive cooperates with magnetic material 1434 mounted in the rotor 1421, with the magnetic material being in the form of a number of circumferentially spaced permanent drive magnets arranged proximate an outer circumferential edge of the rotor 1421.
  • the coils and stators are wedge shaped and circumferentially spaced around the mounting, so as to provide twelve electromagnets radially aligned with the drive magnets 1434 in the rotor 1421, to thereby maximise a degree of magnetic coupling between the magnets in the rotor 1421 and the drive 1430.
  • the heart pump 1400 can further include a magnetic bearing 1440 including at least one bearing coil 1441 that controls an axial position of the impeller within the cavity 1415.
  • the magnetic bearing includes three bearing coils 1441, each of which is mounted on a first leg 1442.1 of respective U-shaped stators, with a second leg 1442.2 being positioned radially inwardly of the first leg 1442.1.
  • the stators are mounted to or integrally formed with a support 1443 and circumferentially spaced 140° apart around the housing so that the first and second legs 1442.1 1442.2 align with respective magnetic material, such as bearing magnets 1444, 1445 within the impeller 1420, allowing an axial position of the impeller 1420 to be controlled.
  • the bearing rotor assembly includes ferromagnetic core target 1444 mounted in the rotor, proximate an outer circumferential edge of the rotor 1421, and a permanent bearing magnet or ferromagnetic material 1445 mounted radially inwardly of the first ferromagnetic core target 1444, so that the ferromagnetic core target and bearing magnets 1444, 1445 align with respective legs 1442.1, 1442.2 of the stators.
  • the ferromagnetic core target can be replaced with a second permanent magnet.
  • the use of a magnetic bearing may not be required and can be replaced by a static physical bearing or hydrodynamic bearing, or the like.
  • the drive 1430 and magnetic bearing 1440 are mounted at opposing ends of the housing 1410 so that the drive and bearing 1430, 1440 are provided proximate opposing surfaces of the rotor 1421 as shown for example in Figure 14B.
  • the drive 1430 is mounted adjacent the side of the impeller 1420 that includes vanes so as to maximise the blood gap between the rotor, vanes and the casing. That is to say, only the vane tips are in closer proximity to the casing, however this blood gap can still be in the order of 200-300 ⁇ m.
  • bearing and drive are configured so that the magnetic forces inherent between the drive 1430 and impeller 1420, and between the magnetic bearing 1440 and impeller 1420 and the hydraulic forces on the impeller 1420 define a balance position within the cavity under conditions of normal flow. This minimises the bearing current required to maintain the position of the impeller 1420 within the cavity under nominal flow conditions.
  • Periodic patient signals such as breathing rate, breathing depth, vascular compliance, atrial contractility and ventricular contractility (in the case of an LVAD) can be detected through the magnetic bearing and drive signals, including allowing both a rate and magnitude of signals to be estimated. An example of this process will now be described with reference to Figure 15.
  • the controller 150 operates to determine drive and/or bearing indicators, in a manner similar to that described above.
  • Examples of the magnetic bearing signals monitored during a monitoring period are shown in Figure 16A, with a derived impeller position being shown in Figure 16B.
  • Measured vascular resistance and derived pump inlet pressure differences are shown in Figure 16C and 16D.
  • changes in inlet pressure are shown at 1601, 1602, whilst periods of increased pulse magnitude caused by pumps speeds of 600RPM and 300RPM (as opposed to the default 100RPM), being shown at 1603, 1604.
  • Fourier analysis is performed, to determine the magnitude of the signals at different frequencies.
  • Figure 17 is an example of a waterfall plot resulting from Fourier analysis performed using the bearing indicator signals of Figure 16A.
  • the plot shows peaks corresponding to the heart pulsatile flow harmonics at 1701, 1702, with the increased magnitude peaks caused by the increased rotation speed pulse magnitude being shown at 1702.
  • a normal breathing rate is shown by the peaks 1711, whereas elevated breathing rate and magnitude is shown at 1712. It will be appreciated that this therefore allows information regarding a breathing rate to be determined.
  • This can be facilitated at step 1520, for example by filtering out signals resulting from operation of the pump, thereby effectively removing the peaks 1701, 1702.
  • one or more periodic parameters can be extracted from the results of the Fourier analysis, with these being monitored at step 1540, for example comparing these to desirable or expected ranges, to ascertain when parameters fall out of range. This can then be used to control the pump and/or generate a notification at steps 1550 or 1560. For example, if a breathing rate is high, this could indicate reduced oxygenation, and so pump speed could be increased. Alternatively and/or additionally, an alert could be generated to notify medical personnel that the values are out of range and an intervention is required.
  • frequency domain analysis and filtering can be used to identify periodic subject signals, with breathing in particular being used to identify hazardous events, allowing clinical staff to be informed using alarms, messages, metrics, or the like, and also optionally allowing the pump operation to be controlled. Whilst this example has focussed on use of the bearing indicator, as described above this could also or alternatively use the drive indicator. [0221] The above described approaches can also be used to measure other parameters, such pump parameters or pump operational performance, specifically if there are any clots, thrombus, or occlusions that are upstream, inside, or downstream to the device and its vascular connections.
  • FIG. 18 One example of this would be to monitor for vibration of the rotor and if the vibration magnitude increases that could indicate that there is a thrombus attached to the rotor which is changing the rotational balance of the spinning rotor.
  • An example of this is shown in Figure 18, in which there are increased peaks 1801 and a spread 1802 in different magnetic bearing signals, indicating the impeller is undergoing vibration, and hence indicating the presence of a thrombus.
  • Monitoring the magnetic bearing signal, and in particular monitoring changes in the bearing parameter to detect thrombus can also be used to determine a location of the thrombus, for example determining whether this is attached to the impeller, and/or partially blocking an inlet or outlet of the pump, which in turn can be used to determine the best intervention for treatment.
  • the above described arrangement uses a bearing indicator to calculate one or more of the following parameters: fluid viscosity, a presence of a thrombus or occlusion, location of a thrombus or occlusion, a breathing rate, a breathing depth, a vascular compliance (inflow or outflow), a ventricular contractility magnitude, an atrial contractility magnitude, an atrial contractility rate, a patient activity, such as running, sleeping, resting or the like, or postural changes.
  • the above described arrangement uses both drive and bearing indicators to calculate one or more of the following parameters: a breathing rate, a breathing depth, a flow, a head pressure, a relative inlet pressure, an absolute pressure within a subject, a systemic / pulmonary vascular pressure, a systemic/pulmonary vascular resistance, a vascular compliance (inflow or outflow), a ventricular contractility magnitude, an atrial contractility magnitude, a level of delivered oxygen, specific events within cardiac cycle, such as aortic valve opening / closing, mitral valve opening / closing, a ratio of systemic and pulmonary vascular resistance, a ventricular contractility rate, an atrial contractility rate, a patient activity, such as running, sleeping, resting or the like, or postural changes.
  • the above described arrangement uses a drive bearing indicator to calculate one or more of the following parameters: a breathing rate, a breathing depth, a vascular compliance (inflow or outflow), an atrial contractility magnitude, or an atrial contractility rate.
  • the location / placement of the heart pump may make obtaining data regarding operation of the heart pump and the subject (including hemodynamic attributes of the subject) more technically challenging in some instances (e.g., because it is located inside the body of an individual).
  • the ability to calculate one or more of the parameters described herein can be advantageous to providing improved therapy / therapeutic treatment for the subject. For example, by increasing the efficiency at which the heart pump operates. Or providing dynamic feedback to the individual or clinician. Or automatically controlling aspects of the heart pump based on one or more parameters.
  • the techniques herein for calculating parameter(s) can be used to improve the health, well-being, and the like of individuals using heart pumps.
  • the techniques can be used by clinicians to provide increased quality of care that is responsive or based on how the calculated parameter(s) change.
  • the approach can also avoid the need to implant additional separate sensors, such as blood pressure sensors, or the like.
  • the apparatus can further include a controller, and otherwise functions largely as previously described, and hence will not be described in further detail.
  • the word “comprise”, and variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated integer or group of integers or steps but not the exclusion of any other integer or group of integers.
  • the term “approximately” means ⁇ 20%.
  • the above embodiments are to be understood as non- limiting illustrative examples of how the present invention, and aspects of the present invention, may be implemented. Further examples of the present invention are envisaged such as applying the invention to axial impellers including axial flow pumps. It is to be understood that any feature described in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the present invention, which is defined in the accompanying claims.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

Pompe cardiaque comprenant un boîtier formant une cavité comprenant au moins une entrée et au moins une sortie, une turbine placée à l'intérieur de la cavité, la turbine comprenant des aubes pour pousser un fluide de l'entrée vers la sortie lors de la rotation de la turbine, un entraînement qui fait tourner la turbine à l'intérieur de la cavité et un palier magnétique comprenant au moins une bobine de palier qui commande une position axiale de la turbine à l'intérieur de la cavité. Un ou plusieurs dispositifs de traitement électronique sont proposés et sont configurés pour déterminer un indicateur de palier relatif à des forces axiales sur la turbine et utiliser l'indicateur de palier pour calculer au moins un paramètre.
PCT/US2024/029438 2023-05-16 2024-05-15 Calcul de paramètre d'une pompe d'assistance circulatoire Pending WO2024242960A1 (fr)

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JP2001517495A (ja) 1997-09-24 2001-10-09 ザ クリーブランド クリニック ファウンデーション 流量制御された血液ポンプシステム
US6527699B1 (en) 2000-06-02 2003-03-04 Michael P. Goldowsky Magnetic suspension blood pump
AU2003902255A0 (en) 2003-05-09 2003-05-29 Queensland University Of Technology Motor
WO2006053384A1 (fr) 2004-11-17 2006-05-26 Queensland University Of Technology Pompe à fluide
US8657874B2 (en) 2009-01-07 2014-02-25 Cleveland Clinic Foundation Method for physiologic control of a continuous flow total artificial heart
AU2010237614B2 (en) * 2009-04-16 2013-11-07 Bivacor Pty Ltd Heart pump controller
EP3081246A1 (fr) * 2015-04-13 2016-10-19 Berlin Heart GmbH Pompe et procédé de fonctionnement d'une pompe pour liquides
WO2017015268A1 (fr) 2015-07-20 2017-01-26 Thoratec Corporation Estimation de débit à l'aide de capteurs à effet hall
EP3400033B1 (fr) 2016-01-06 2024-06-05 Bivacor Inc. Pompe cardiaque avec commande de position axiale de turbine

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