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WO2025242723A1 - Surveillance sans fil de la fonction cardiaque - Google Patents

Surveillance sans fil de la fonction cardiaque

Info

Publication number
WO2025242723A1
WO2025242723A1 PCT/EP2025/063970 EP2025063970W WO2025242723A1 WO 2025242723 A1 WO2025242723 A1 WO 2025242723A1 EP 2025063970 W EP2025063970 W EP 2025063970W WO 2025242723 A1 WO2025242723 A1 WO 2025242723A1
Authority
WO
WIPO (PCT)
Prior art keywords
heart
sensing device
circuit board
flexible circuit
antenna
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/EP2025/063970
Other languages
English (en)
Inventor
Jonas TYSSØ
Erik Fosse
Mattis Spieler ASP
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.)
Cardiaccs AS
Original Assignee
Cardiaccs AS
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 Cardiaccs AS filed Critical Cardiaccs AS
Publication of WO2025242723A1 publication Critical patent/WO2025242723A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • 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
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1121—Determining geometric values, e.g. centre of rotation or angular range of movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
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    • A61B5/48—Other medical applications
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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
    • A—HUMAN NECESSITIES
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    • 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
    • A61B5/68—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
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    • 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
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/05—Surgical care
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board

Definitions

  • the present disclosure relates to a system, method, and computer program product for wireless monitoring of cardiac function.
  • a sensor such as by attaching the sensor on the heart surface, i.e. on the exterior of the heart or in the heart wall.
  • Implanting a heart sensor enables a surgeon or other medical professionals to monitor the functioning of the heart during and after surgery.
  • the heart sensor is configured to monitor various parameters of the heart, such as motion, pressure or electrical impulses. That data is then often analysed to provide information about heart function such as cardiac rhythm, loading, volume or work. Such information can be used to ensure that the heart is functioning normally or to detect abnormalities.
  • the heart sensor In order to measure heart parameters, the heart sensor is attached to an external surface of the heart wall by suture or otherwise. In the case that the patient undergoes surgery in order to fit a cardiac assist device, the heart sensor can be directly attached to the heart surface or cardiac assist device in order to monitor its function.
  • the applicant’s earlier patent publications WO2014207225A1 and WO2018229726A1 describe sensors that can be attached on the heart, e.g. on an outer surface thereof, such as by using anchors similar to those used for pacemaker electrodes.
  • the heart sensor typically comprises a micro-electromechanical system (MEMS), a piezoelectrical system, or electrodes attached to a printed circuit board and one or more wires or connecting to an external device.
  • MEMS micro-electromechanical system
  • a through hole is made in the patient’s chest and the wires are threaded via the through hole. In this way, the chest cavity can be sealed to complete the surgery but the heart monitor can still be used to measure heart parameters.
  • Other prior art systems include catheter based, transvascular methods for installing a heart sensor. Such methods include feeding a sensor on the end of a wire into an artery, such as the carotid artery, and guiding the sensor through a patient’s circulatory system until it arrives at the heart. Then, the sensor can be guided and anchored into an internal wall of the heart for monitoring heart parameters.
  • Prior art heart sensors such as the ones described above are typically in place only temporarily or require dedicated systems that are usually only found in hospitals for connection to and powering of the sensors.
  • the present disclosure provides a sensing device, comprising: a flexible circuit board comprising a first end and a second end; one or more sensors attached to the first end of the flexible circuit board; and an antenna attached to the second end of the flexible circuit board, wherein the antenna is configured to wirelessly receive power from and to wirelessly transmit data to and/or receive data from an external device, wherein the sensing device is configured to be implanted in a body and wherein the first end of the flexible circuit board is configured to be attached to a surface of a heart in the body by a first anchoring means and the second end of the flexible circuit board is attached within the body by a second anchoring means.
  • the second end is advantageously attached within the body at a point spaced apart from the first end and the first anchoring means, i.e. the second end is not attached to the outside of the heart (either directly or via a cardiac assist device) along with the first end, but instead the second anchoring means is attached spaced apart from the heart and typically placed subcutaneously or subfascially as described in more detail below.
  • the first end of the flexible circuit board is attached at an exterior surface of the heart (e.g. to ensure movement of the first end together with the surface of the heart) whilst the second end thereof may be attached to body tissues spaced apart from the heart.
  • the flexible circuit board has a length between the first end and the second end, and the two anchoring means may be spaced apart by a distance corresponding to a major portion of this length, e.g. at least 50% of the length.
  • the sensor(s) may be placed at the heart whilst the antenna can be closer to the external device, which is a device placed outside the body.
  • the flexible circuit board is a flexible printed circuit board (PCB) comprising a dielectric substrate film, which forms the base of the PCB, and electrical conductors printed on the substrate film that electrically connect components that are attached or printed onto the PCB.
  • Components can be attached to a flexible PCB by the use of soldering, electrically conductive adhesive, non-electrically conductive adhesive, or other suitable means.
  • the flexible circuit board is flexible in the sense that the PCB is formed as a thin layer or series of layers such that it is capable of bending or twisting without breaking. This is in comparison to rigid PCBs, which cannot bend or flex significantly without breaking.
  • Flexible PCBs over rigid PCBs is that there is a significant reduction in size and weight, while retaining the same ability for components on the PCB to be connected.
  • Flexible PCBs also have an advantage of reducing or eliminating the use of wiring in a circuit by integrating and guiding the signals inside the PCB itself to interface directly with other components, meaning that wires to connect the PCB to another component are not needed. That is, flexible PCBs have conductive elements that can electrically connect components attached or printed onto the PCB.
  • Flexible PCBs have a further advantage in the context of their use for electronics in monitoring aspects of human or animal physiology, in that, a device that is implanted in a human or animal body must be capable of withstanding stresses placed on the device due to movement of the body. Such stresses can result from a person moving about, which could be further exacerbated by larger or more extreme movements during activities such as exercising or playing a sport. Stresses can also result from basic bodily functions, such as the movement of a thoracic diaphragm during breathing or the movement of heart muscles as a heart beats, thereby causing the heart muscles to expand and contract.
  • a sensing device may be attached or implanted to the part of the body. If a sensing device is attached or implanted to a part of the body, such as the skin or an internal organ, it must be capable of withstanding movement of the part of the body so that the sensing device does not become dislodged from that part of the body. This is because dislodgement of the sensing device could result in an inability to monitor the part of the body to which the sensing device should be attached.
  • Reattaching or re-implanting the sensing device may then require a person to visit a medical professional or undergo surgery, which is inconvenient for the person and, if surgery is required, could place severe strain on the body and includes a risk of injury as well as placing a burden on a hospital and its staff.
  • a flexible circuit board for a sensing device that is attached to or implanted in a body, such as by attachment of a first end of the flexible circuit board to an external surface of the heart, provides an advantage of increasing the resilience of the sensing device. This is because the flexible circuit board is capable of bending or twisting when a surface to which the flexible circuit board is attached moves.
  • the flexible circuit board also typically has a lightweight construction compared to rigid PCBs, thereby reducing the likelihood of dislodgement during movement due to inertia of the circuit board.
  • the present disclosure provides a solution to this problem by enabling the transmission of power to the heart sensing device wirelessly. This is done by using an electrically powered transmitter device outside the patient that transmits power wirelessly to the heart sensing device inside the patient, thereby eliminating the need for a power source in the implanted sensing device and/or wires connected to the implanted sensing device.
  • NFC Near field power transfer, or near field communication
  • a power source is connected to a transmitting antenna and a load is connected to a receiving antenna and the load is powered by the power source by transmitting a time-varying magnetic field from the transmitter, thereby inducing an electric current in the receiving antenna.
  • the sensing device can be powered by inductive coupling through the antenna of the sensing device.
  • the antenna of the sensing device can be embedded inside the flexible PCB under the patient skin as part of the implanted sensing device.
  • the sensing device is configured to be wirelessly powered by near field communication (NFC).
  • NFC near field communication
  • the sensing device of the present disclosure does not need to be replaced in order for the sensing device to continue operation compared to solely battery-powered devices.
  • NFC also has an advantage of enabling wireless data transfer between the sensing device and an external device.
  • the sensing device is configured to wirelessly transmit data to and/or wirelessly receive data from an external device.
  • the wireless transfer of power and data by NFC is to be understood to refer to all wireless power and data transfer methods that are suitable for communication with a medical device in a patient.
  • the first end of the flexible circuit board is anchored to a surface of a heart such that there is little to no relative movement between the first end of the flexible circuit board and the heart surface. Thus, the first end may, in use, move together with movements of the outer surface of the heart.
  • the one or more sensors are attached to the first end of the flexible circuit board.
  • the one or more sensors may be attached to the first end of the flexible circuit board by crimping, soldering, or any other appropriate connection method.
  • the one or more sensors are configured to detect and measure one or more of the following parameters of the heart surface: pressure, position, displacement, velocity, acceleration, vibration, orientation, and/or angular velocity. Analysis of one or more of the one or more parameters can then be used to determine additional heart parameters such as: electrical activity, heart volume, heart loading (also known as preload), ventricular pressure, and/or contractility. Electrical activity is typically displayed to a user in the form of an electrocardiogram (ECG).
  • ECG electrocardiogram
  • Changes in the motion or electrical activity of the heart may, in one or more embodiments, be used to detect cardiac dysfunction such as reduced pumping capacity, heart muscle infarction and/or rejection of a transplanted heart muscle. Therefore, in one or more embodiments, the one or more sensors are used to detect cardiac dysfunction, reduced pumping capacity, and/or pump malfunction in patients with artificial heart pumps by enabling analysis of the heart parameters and determining additional heart parameters. In embodiments where a patient has a cardiac assist device implanted at the heart, vibrations of the cardiac assist device will propagate through the heart surface. Therefore, the one or more sensors of the sensing device anchored to the heart surface will also detect and measure vibrations of the cardiac assist device.
  • the first end of the flexible circuit board is anchored directly to the cardiac assist device.
  • An advantage of this arrangement is to directly detect and measure vibrations of the cardiac assist device.
  • the first end of the flexible circuit board may be anchored by a bracket, screw, glue or any other suitable anchoring means.
  • the second end of the flexible circuit board is attached within the body by a second anchoring means.
  • the second end of the flexible circuit board is positioned on or proximate the fascia, either between the fascia and the muscle layer or between the fascia and the epidermal layer.
  • the second end is implanted intramuscularly or in the dermal layer.
  • the second anchoring means is any means of fixing the second end within the body. In some embodiments, this is by suture.
  • the second end is implanted and the tissue surrounding the flexible circuit board is allowed to heal such that the second end is fixed within the body, meaning that the second end is anchored by bodily tissue.
  • the second anchoring means is positioned subcutaneously or subfascially.
  • Each of the one or more sensors may be a piezoelectrical sensor, a micromechanical electrical system (MEMS), electrodes, or any other suitable sensor.
  • MEMS micromechanical electrical system
  • each sensor may be the same type of sensor or comprise a mixture of sensor types.
  • Electrodes are used to detect and measure electrical activity of the heart in order to produce an electrocardiogram (ECG).
  • ECG electrocardiogram
  • the one or more sensors include electrodes
  • this can comprise two or more exposed electrodes connected to the flexible circuit board and located at any part of the first end of the flexible circuit board that is exposed to the heart muscle, e.g. connected to it via a suture or via a connection to a cardiac assist device on the heart. That is, the electrodes are positioned on the first end of the flexible circuit board such that they may be in contact with the heart surface at the outside of the heart when the first end of the flexible circuit board is anchored to the heart surface.
  • the ECG may be used to obtain an accurate detection of the heart cycle. This may be used together with the motion signals and other heart parameters to assess heart function.
  • the ECG signal can also be used to detect complications, such as rejection of a transplanted heart or rhythm disturbances.
  • the one or more sensors comprise two or more electrodes and one or more motion sensors.
  • the one or more motion sensors may be configured to measure one or more of pressure, position, displacement, velocity, acceleration, vibration, orientation, and angular velocity.
  • the one or more sensors comprise an accelerometer and/or a gyroscope.
  • the sensing device comprises a controller.
  • the controller may be a microprocessor or any other suitable processor.
  • the controller is connected to the flexible circuit board.
  • the controller is configured to process data received from the one or more sensors before being transmitted to an external device. Filtering data can be used to determine importance of the data, which may determine whether the data is transmitted to the external device. Filtering data can therefore be used to reduce the volume of data communicated by the sensing device. This has an advantage of reducing the power usage of the sensing device by reducing the total amount of data that is wirelessly transmitted from the device.
  • the antenna of the sensing device is at the second end of the flexible circuit board.
  • the antenna is configured to wirelessly transmit data from the sensing device to an external device and/or wirelessly receive data from the external device, and is configured to wirelessly receive power from the external device.
  • the antenna is configured to wirelessly receive power and wirelessly transmit data only.
  • the antenna may be integrated within the flexible circuit board or connected to the second end of the flexible circuit board.
  • the antenna may be in the form of a coiled wire inside the flexible circuit board.
  • the antenna may be attached by crimping, soldering or any other suitable connection means.
  • the sensing device comprises an encapsulation and/or a coating.
  • the encapsulation and/or coating covers the whole of the sensing device.
  • the Encapsulation may be a liquid crystal polymer (LCP) encapsulation or any other suitable material.
  • the coating may be a parylene coating or any other suitable coating material.
  • the sensing device is configured to communicate with an external device, i.e. a device external to the sensing device and typically a device that is configured to be placed on the outside of the patient’s body.
  • the external device is configured to wirelessly provide power to the sensing device.
  • the external device is also configured to wirelessly receive data from the sensing device and/or wirelessly transmit data to the sensing device.
  • the external device is configured to wirelessly transmit power and wirelessly receive data only.
  • the external device is located outside the body of the patient.
  • the external device is part of a control system for controlling the sensing device.
  • the external device is a mobile communications device. In other embodiments, the external device is a communications patch.
  • the mobile communications device may be a smartphone with NFC functionality or a dedicated communications device.
  • the external device comprises an external device antenna for communication with the sensing device.
  • the external device is configured to transmit power to the sensing device and to receive data from the sensing device using the external device antenna.
  • the external device may also be configured to transmit data to the sensing device using the external device antenna.
  • the external device is configured to control functions of the sensing device, such as a measurement frequency of the one or more sensors. If the sensing device comprises a controller, the external device may be configured to command the controller to change data filtering parameters.
  • the external device comprises a processor and a memory and is configured to store and process data received from the sensing device.
  • the processor may be configured to process the data received from the sensing device to track heart parameters.
  • the processor may also be configured to analyse the data to determine additional heart parameters.
  • the communications patch is configured to connect to the sensing device.
  • a mobile communications device is configured to connect with the communications patch.
  • the control system comprises the communications patch and the mobile communications device.
  • the communications patch may use the external device antenna for communication with the sensing device and the mobile communications device or it may comprise a first external device antenna for dedicated communication with the sensing device and a second external device antenna for dedicated communication with the mobile communications device.
  • the mobile communications device may be a smartphone with NFC functionality or a dedicated communications device.
  • the communications patch comprises a power source, such as a battery, or a connection to an external power source.
  • the communications patch is configured to power the sensing device using the power source.
  • the communications patch is configured to be attached to the patient by an attachment means, such as glue or any other suitable attachment means. To ensure that the communications patch is able to communicate with the sensing device, the communications patch must be placed within communications range of the sensing device. The communications patch may be placed on the chest or elsewhere on the upper torso of the patient.
  • the communications patch comprises a processor and a memory and is configured to store and process data received from the sensing device.
  • the mobile communications device comprises a processor and a memory and is configured to store and process data received from the sensing device.
  • the processor may be configured to process the data received from the sensing device to track heart parameters.
  • the processor may also be configured to analyse the data to determine additional heart parameters.
  • the control system may be configured to display the heart parameters on a display.
  • the control system comprises a server.
  • the mobile communications device is configured to communicate with the server over a mobile network, internet, or other suitable method.
  • the mobile communications device is configured to transmit data to the server for storage and/or processing.
  • the data sent to the server may be raw data from the one or more sensors or data that is processed by the control system and/or the sensing device.
  • the server may be configured to transmit processed data back to the mobile communications device for display to the user.
  • operation of the sensing device is controlled remotely, via the server.
  • the control system is configured to provide an alert.
  • the alert may be sent to the patient or user when a complication or failure of the heart and/or a cardiac assist device is detected.
  • the alert may be an audible alert, a visual alert, a haptic alert, or any combination of these.
  • the user may be a medical staff member or any person that is responsible for care of the patient.
  • an alert message is also sent to a hospital or remote member of a caring team to alert them of the complication or failure.
  • the present disclosure provides a system comprising: the sensing device of the first aspect and a control system.
  • the control system comprises an external device, wherein the external device comprises an external device antenna and a power source, and wherein the external device is configured to wirelessly transmit power to and to wirelessly transmit data to and/or receive data from the sensing device.
  • the control system comprises any of the features as detailed above.
  • the present disclosure provides a method of monitoring a heart of a patient using the system of the second aspect, comprising: wirelessly powering the sensing device using the external device; measuring, using the one or more sensors, data relating to one or more heart parameters; and wirelessly transmitting the data from the sensing device to the external device.
  • the method may include use of a sensing device and/or an external device with any of the features discussed above.
  • One or more embodiments of the method comprise the external device being a communications patch, as discussed in above aspects.
  • the method optionally comprises attaching the communications patch to the patient using an attachment means, such as glue.
  • the communication patch may be placed on the patient and in communications range of the sensing device, for example, on the upper torso or chest of the patient.
  • the method comprises analysing the data to determine one or more additional heart parameters.
  • the data is analysed by a processor of the control system.
  • the method may further comprise determining a complication or failure of the heart by evaluation of the heart parameters and/or the additional heart parameters.
  • the method comprises providing, by the control system, an alert.
  • the alert may be sent to the patient or user when a complication or failure of the heart and/or a cardiac assist device is detected.
  • the alert may be an audible alert, a visual alert, a haptic alert, or any combination of these.
  • the user may be a medical staff member or any person that is responsible for care of the patient.
  • an alert message is also sent to a hospital or remote member of a caring team to alert them of the complication or failure.
  • the present disclosure provides a computer program product, comprising instructions that configure the system of the second aspect to: power, by the control system, the sensing device; measure, using the one or more sensors, data relating to one or more heart parameters; and transmit the data from the sensing device to the external device.
  • the computer program product is executable on a non-transient computer readable medium.
  • a cardiac assist device may also be called a heart pump.
  • the one or more sensors may be configured to detect one or more of the following parameters: pressure, position, displacement, velocity, acceleration, vibration, orientation, angular velocity, heart volume, heart loading (also known as preload), ventricular pressure, and/or contractility.
  • the one or more sensors are able to measure with increased accuracy the vibrations of the cardiac assist device, compared to an arrangement where the first end of the flexible circuit board is attached to a heart surface.
  • the one or more sensors may be configured to measure vibration. Analysis of vibration parameters measured by the one or more sensors can then be used to determine, development of thrombus in the pump, pump suction issues, reduced pumping capacity, and/or pump malfunction.
  • analysis of heart parameters is carried out in a processor.
  • the circuit board is not necessarily flexible. That is, the disclosure provides a sensing device comprising a circuit board comprising a first end and a second end; one or more sensors attached to the first end of the circuit board; and an antenna attached to the second end of the circuit board, wherein the antenna is configured to wirelessly receive power from an external device and to wirelessly transmit data from the one or more sensors to the external device and/or wirelessly receive data from the external device, wherein the sensing device is implanted in a body and wherein the first end of the circuit board is configured to be attached to a heart in the body by a first anchoring means and the antenna is attached to within the body by a second anchoring means.
  • the antenna is not necessarily configured to receive power wirelessly. That is, the disclosure provides a sensing device comprising a flexible circuit board comprising a first end and a second end; one or more sensors attached to the first end of the flexible circuit board; and an antenna attached to the second end of the flexible circuit board, wherein the sensing device is configured to be implanted in a body and wherein the first end of the flexible circuit board is configured to be attached to a heart in the body by a first anchoring means and the second end of the flexible circuit board is attached to within the body by a second anchoring means.
  • the sensing device may comprise a power source such as a battery, for powering the sensing device.
  • the sensing device is powered wirelessly and comprises a rechargeable power source, wherein the rechargeable power source is configured to be charged when the sensing device is receiving power.
  • Figure 1 illustrates a sensing device
  • Figure 2 illustrates a heart monitoring system with wireless communication between an implanted sensing device and a mobile device
  • Figure 3 illustrates a heart monitoring system comprising wireless communication between an implanted sensing device and an external communications patch.
  • Figure 4 is a schematic diagram of a heart monitoring system.
  • a sensing device 100 for monitoring parameters of a heart in a person comprises a motion sensor, such as an accelerometer, gyroscope or other sensor suitable for measuring myocardial motion.
  • the myocardial motion comprises pressure, position, displacement, velocity, acceleration, vibration, orientation, and angular velocity of heart tissue.
  • the sensing device 100 also comprises two or more electrodes for measuring electrical impulses of the heart.
  • the motion sensor and the electrodes are collectively referred to as the sensors 102 of the sensing device 100.
  • the sensors 102 are connected to a first end 106 of a flexible circuit board 104.
  • the first end 106 of the flexible circuit board 104 is attached to a surface of the heart by a first anchoring means, e.g. a suture, such that the sensors 102 do not move significantly relative to the surface of the heart.
  • a first anchoring means e.g. a suture
  • the first end 106 is advantageously positioned on or at an external surface of the heart by virtue of the first end 106 being connected to the heart surface by the first anchoring means.
  • Each electrode is a pad made from an electrically conductive material. Each electrode is spaced apart from one another on the flexible circuit board 104. When the first end 106 of the flexible circuit board 104 is attached to the surface of the heart, the flexible circuit board 104 is attached such that the two or more electrodes are in physical contact with the heart surface.
  • the electrical activity of the heart can be monitored and conditions, such as arrhythmia, may be detected if abnormal electrical activity is detected.
  • the electrical activity of the heart can be tracked to produce an echocardiogram (ECG).
  • ECG echocardiogram
  • the sensing device 100 also comprises an antenna 110 at a second end 108 of the flexible circuit board 104.
  • the antenna 110 is a coiled wire in the flexible circuit board 102.
  • the antenna 110 and the sensors 102 are electrically connected to one another through the flexible circuit board 104.
  • the second end 108 of the flexible circuit board 104 is implanted proximate to the fascia.
  • the antenna 110 is configured to transmit data from the sensors 102 to a receiver that is external to the body.
  • the sensing device 100 is configured to wirelessly transmit data from the sensors 102 to a receiver that is external to the body.
  • the antenna 110 is also configured to receive power from an external device.
  • the antenna 110 is configured to operate as a near field communication (NFC) device. That is, the antenna 110 is configured to receive an electromagnetic signal from an externally powered transmitter, which creates an electric current in the antenna.
  • the implanted sensing device 100 is then configured to use the electric current to power the operation of the sensors 102 and to enable the antenna 110 to transmit data to an external receiver. In other words, the sensing device 100 is powered by energy received from the external device.
  • NFC near field communication
  • the sensing device 100 is implanted in a person 200 and anchored to the person’s heart 202.
  • the sensing device is configured to communicate with a control system 120, wherein the control system 120 comprises an external device.
  • the external device is a mobile communications device 122, such as a mobile phone.
  • the mobile communications device 122 comprises software, such as a proprietary app.
  • the mobile communications device 122 comprises an external device antenna for transmitting and/or receiving signals.
  • the mobile communications device 122 comprises a processor and a memory.
  • the mobile communications device 122 comprises a power source, such as a battery.
  • the software is stored in the memory and is executable on the processor.
  • the software contains instructions that, when executed on the processor, configures the mobile communications device 122 to power and communicate with the sensing device 100.
  • the mobile communications device 122 is configured to operate as an NFC transmitter. In this way, the mobile communications device 122 is configured for two-way communication to transmit an electromagnetic signal to the antenna 110 of the implanted sensing device 100. Transmission of the electromagnetic signal to the antenna 110 generates an electric current in the implanted sensing device 100 for powering the sensors 102, as set out above.
  • Use of NFC requires the mobile communications device 122 to be in close proximity to the antenna 110.
  • the antenna 110 of the sensing device is positioned in the chest cavity of the body of a person 200. So, to power the sensing device 100, the mobile communications device 122 is placed proximate to the person’s chest by a user and emits the electromagnetic signal to the antenna 110. In this way, the mobile communications device 122 is configured to wirelessly power the sensing device 100.
  • the user may be a medical professional or the person 200 in which the sensing device 100 is implanted.
  • the mobile communications device 122 is configured to wirelessly receive data from the sensing device 100.
  • the antenna 110 is capable of transmitting data from the sensors 102.
  • the antenna 110 is configured to connect to the mobile communications device 122 and wirelessly transmit data to the mobile communications device 122.
  • the data received from the implanted sensing device 100 can be processed and analysed in order to track heart parameters and to determine additional information about the function of the heart 202.
  • the software configures the mobile communications device 122 to process data received from the sensing device using the processor. For example, analyses such as advanced calculations, frequency and motion data analysis, pattern recognition can be performed on the data.
  • analyses such as advanced calculations, frequency and motion data analysis, pattern recognition can be performed on the data.
  • the analysed data is presented to the user on a display of the mobile communications device to provide the user with information about the status of the heart 202.
  • Pre-processed data and/or post-processed data is stored locally on the memory of the mobile communications device 122.
  • the user can use the mobile communications device 122, via the software, to control the sensing device 100. That is, the mobile communications device 122 is configured to wirelessly send instructions to the sensing device 100.
  • the instructions comprise commands for the sensors 102 to take measurements of heart parameters.
  • the instructions also comprise commands to adjust the frequency of the measurements.
  • the mobile communications device 122 can be used by the user to command the sensing device 100 to take a single measurement or to take a plurality of measurements over a period of time. The plurality of measurements can be taken at regular or irregular intervals of time.
  • the mobile communications device 122 comprises a display 124.
  • the mobile communications device 122 is configured to provide an alert when a complication or failure of the heart is detected.
  • the display 124 is configured to show a visual alert to the user.
  • FIG. 3 shows another arrangement for the control system 120.
  • the control system comprises a communications patch 130 and a mobile communications device 132.
  • the communications patch 130 is attached to the skin of the person 200 using an attachment means, such as glue or an adhesive, and is positioned within communications range of the sensing device 100, proximate to the location of the antenna 110 of the sensing device 100.
  • the communications patch 130 comprises a power source, such as a battery, and an external device antenna.
  • the external device antenna is configured to communicate with the antenna 110 of the sensing device 100.
  • the communications patch 130 is configured to operate as an NFC transmitter. In this way, the communications patch 130 is configured to use an NFC protocol to power the sensing device 100.
  • Use of NFC requires the communications patch 130 to be in close proximity to the antenna 110, so positioning of the communications patch 130 on an external skin surface proximate to the location of the antenna 110 of the sensing device 100 enables the use of NFC.
  • the antenna 110 of the sensing device 100 is positioned in the chest cavity of the body of a person 200. So, to power the sensing device 100, the communications patch 130 is configured to emit the electromagnetic signal to the antenna 110. In this way, the communications patch 130 is configured to wirelessly power the sensing device 100.
  • the mobile communications device 132 is configured to be connected to the communications patch 130.
  • the mobile communications device 132 may be connected to the communications patch 130 by a wired connector and/or by wireless means, such as Bluetooth.
  • the mobile communications device 132 may be a mobile phone or a dedicated medical device.
  • the mobile communications device 132 comprises software, such as a proprietary app.
  • the mobile communications device 132 comprises an antenna for transmitting and/or receiving signals.
  • the mobile communications device 132 comprises a processor and a memory.
  • the software is stored in the memory and executed on the processor.
  • the software contains instructions that, when executed on the processor, configures the mobile communications device 132 to communicate with the communications patch 130 and with the sensing device 100.
  • the mobile communications device 132 is configured to command the communications patch 130 to wirelessly power and communicate with the sensing device 100 via the external device antenna. In this way, the mobile communications device 132 is configured to control the sensing device 100.
  • the mobile communications device 132 is configured to receive data from the sensing device 100 via the communications patch 130.
  • the antenna 110 is capable of transmitting data from the sensors 102.
  • the antenna 110 is configured to connect to the communications patch 130 and to transmit data to the mobile communications device 132 via the communications patch 130.
  • the mobile communications device 132 comprises a display 134.
  • the mobile communications device 132 is configured to provide an alert when a complication or failure of the heart is detected.
  • the display 134 is configured to show a visual alert to the user.
  • FIG 4 is a schematic diagram of a sensing device 100 in wireless communication with a control system 120, where the control system is in wireless communication with a server 140. This arrangement is compatible with each of the systems depicted in Figures 2 and 3.
  • the control system 120 is configured to communicate with the server 140 via a wireless network.
  • the server 140 comprises a processor and a memory.
  • the control system is configured to upload data received from the sensing device 100 for processing at the server 140.
  • the server 140 is also configured for remote storage of pre- and post-processed data.

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Abstract

Dispositif de détection (100), comprenant : une carte de circuit imprimé souple (104) comprenant une première extrémité (106) et une seconde extrémité (108) ; un ou plusieurs capteurs (102) fixés à la première extrémité (106) de la carte de circuit imprimé souple ; et une antenne (110) fixée à la seconde extrémité (108) de la carte de circuit imprimé souple, l'antenne (110) étant configurée pour recevoir sans fil de l'énergie provenant de et pour transmettre sans fil des données à un dispositif externe (122 ; 130, 132) et/ou recevoir des données en provenance de celui-ci, le dispositif de détection (100) étant configuré pour être implanté dans un corps et la première extrémité (106) de la carte de circuit imprimé souple (104) étant configurée pour être fixée à une surface d'un cœur dans le corps par un premier moyen d'ancrage et la seconde extrémité (108) de la carte de circuit imprimé souple (104) étant fixée à l'intérieur du corps par un second moyen d'ancrage.
PCT/EP2025/063970 2024-05-21 2025-05-21 Surveillance sans fil de la fonction cardiaque Pending WO2025242723A1 (fr)

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GB2407229.0A GB2641249A (en) 2024-05-21 2024-05-21 Wireless monitoring of cardiac function

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WO2014207225A1 (fr) 2013-06-27 2014-12-31 Oslo Universitetssykehus Hf Surveillance d'un dispositif d'assistance cardiaque
US20180028824A1 (en) * 2015-02-06 2018-02-01 Nalu Medical, Inc. Medical apparatus including an implantable system and an external system
WO2018229726A1 (fr) 2017-06-16 2018-12-20 Cardiaccs As Procédés et dispositifs de fixation d'un capteur au niveau du cœur
WO2021110761A1 (fr) 2019-12-02 2021-06-10 Cardiaccs As Estimation d'une valeur associée à la tension de la paroi du cœur
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JP2021518208A (ja) * 2018-03-23 2021-08-02 メドトロニック，インコーポレイテッド ＡＶ同期ＶｆＡ心臓治療
BR112023002695A2 (pt) * 2020-08-31 2023-05-02 Edwards Lifesciences Corp Sistemas e dispositivos de monitoramento para implantes cardíacos
CA3208990A1 (fr) * 2021-02-05 2022-08-11 Edwards Lifesciences Corporation Dispositifs d'implant de capteur de derivation
CN115581542A (zh) * 2022-09-23 2023-01-10 浙江智柔科技有限公司 用于瓣膜压差测量的压力传感器及可植入心脏瓣膜

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WO2014207225A1 (fr) 2013-06-27 2014-12-31 Oslo Universitetssykehus Hf Surveillance d'un dispositif d'assistance cardiaque
US20180028824A1 (en) * 2015-02-06 2018-02-01 Nalu Medical, Inc. Medical apparatus including an implantable system and an external system
WO2018229726A1 (fr) 2017-06-16 2018-12-20 Cardiaccs As Procédés et dispositifs de fixation d'un capteur au niveau du cœur
WO2021110761A1 (fr) 2019-12-02 2021-06-10 Cardiaccs As Estimation d'une valeur associée à la tension de la paroi du cœur
US20230181910A1 (en) * 2020-05-31 2023-06-15 Maxwell Biomedical, Inc. Pacing and sensing devices and control system
WO2023287859A1 (fr) * 2021-07-13 2023-01-19 Maxwell Biomedical Inc. Système de stimulation

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