WO2023174684A1 - System and method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient - Google Patents

System and method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient Download PDF

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Publication number
WO2023174684A1
WO2023174684A1 PCT/EP2023/055120 EP2023055120W WO2023174684A1 WO 2023174684 A1 WO2023174684 A1 WO 2023174684A1 EP 2023055120 W EP2023055120 W EP 2023055120W WO 2023174684 A1 WO2023174684 A1 WO 2023174684A1
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WO
WIPO (PCT)
Prior art keywords
patient
implantable cardioverter
cardioverter defibrillator
ventricular
mobile device
Prior art date
Application number
PCT/EP2023/055120
Other languages
French (fr)
Inventor
Jens Mueller
Thomas Doerr
Miro SELENT
Original Assignee
Biotronik Se & Co. Kg
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Publication date
Application filed by Biotronik Se & Co. Kg filed Critical Biotronik Se & Co. Kg
Publication of WO2023174684A1 publication Critical patent/WO2023174684A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258—Alerting the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting

Definitions

  • the invention relates to a system for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient.
  • the invention relates to a method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient.
  • DE 20 2016 008 929 U1 discloses a cardioverter defibrillator for suitability determination for the administration of a defibrillator shock, wherein the cardioverter defibrillator is configured to detect a ventricular tachycardia in a subject, obtain an indication of the person's blood pressure, and if the blood pressure is below a predetermined threshold, determine that administration of a defibrillator surge is appropriate.
  • the implantable defibrillator executes algorithms that perform classification. It is thereby essential to avoid inadequate shocks.
  • Electrode fractures, perforations, electrode displacements and/or significant impedance changes in a short time are some of the most common reasons for inadequate shock delivery. It is therefore an object of the present invention to provide an improved system and method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient capable of reducing a number of inadequate shocks in active implantable defibrillators.
  • the object is solved by a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient having the features of claim 1.
  • the object is solved by a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient having the features of claim 12.
  • the present invention provides a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient.
  • the system comprises an implantable cardioverter defibrillator, configured to acquire first heart rate data of the patient.
  • the system comprises a mobile device, in particular a wearable device, configured to acquire second heart rate data of the patient, wherein the implantable cardioverter defibrillator is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode of the patient using the first heart rate data acquired by the implantable cardioverter defibrillator and the second heart rate data acquired by the mobile device.
  • a mobile device in particular a wearable device, configured to acquire second heart rate data of the patient
  • the implantable cardioverter defibrillator is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode of the patient using the first heart rate data acquired by the implantable cardioverter defibrillator and the second heart rate data acquired by the mobile device.
  • the present invention moreover provides a computer-implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient.
  • the method comprises acquiring first heart rate data of the patient by means of an implantable cardioverter defibrillator, in particular an implantable cardioverter defibrillator.
  • the method comprises acquiring second heart rate data of the patient by means of a mobile device, in particular a wearable device, and classifying the ventricular tachycardia and/or ventricular fibrillation episode of the patient using the first heart rate data acquired by the implantable cardioverter defibrillator and the second heart rate data acquired by the mobile device, in particular by the implantable cardioverter defibrillator.
  • the present invention provides a computer program with program code to perform the method of the present invention when the computer program is executed on a computer.
  • the present invention provides a computer-readable data carrier containing program code of a computer program for performing the method of the present invention when the computer program is executed on a computer.
  • An idea of the present invention is to reduce a number of inadequate shocks in active implantable defibrillators by incorporating reference measurements from a mobile device such as a smartwatch.
  • a second reference value detected by the mobile device is thus obtained within a predetermined time period. Shock delivery by the implant does not occur until the mobile device has also detected the arithmetic. If the mobile device does not detect the arrhythmia, no immediate shock is delivered. The patient must confirm on the mobile device that he or she is well. If this confirmation does not occur within a predefined period of time, the shock is delivered.
  • the implantable cardioverter defibrillator is configured to detect the ventricular tachycardia and/or ventricular fibrillation episode of a patient using at least one detection algorithm comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm.
  • a detection algorithm comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm.
  • the implantable cardioverter defibrillator upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, is configured to acquire the second heart rate data of the patient from the mobile device, in particular by sending a command to the mobile device requesting the second heart rate data of the patient.
  • Said command advantageously has no direct influence on a diagnosis and therapy function of the implant.
  • the implantable cardioverter defibrillator comprises a Bluetooth Low Energy interface configured to communicate with the mobile device, in particular to acquire the second heart rate data of the patient from the mobile device.
  • the second heart rate data can thus be accessed any time the implantable medical device detects a ventricular tachycardia and/or ventricular fibrillation episode of the patient.
  • the implantable cardioverter defibrillator upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, is configured to control the mobile device to prompt the patient to confirm a wellbeing. Prompting the patient to confirm his or her wellbeing is a further security feature that advantageously contributes to a reduction in inadequate shocks administered by the implantable medical device.
  • the patient is thus able to influence shock delivery because he or she must confirm his or her wellbeing. If for example the ICD falsely detects a tachycardia due to an electrode rupture, it is a safety feature that the patient confirms whether he or she is doing well or not, so that there is no unintended delivery of therapy by the ICD. In order to confirm his or her wellbeing the patient must then interact with the mobile device in a predetermined manner, e.g., press a predetermined combination of buttons or simply push a button.
  • the implantable cardioverter defibrillator is configured, if upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient a classification result represents a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, in particular if this occurs at least a predetermined number of times, to send a notification to a service provider.
  • a classification result represents a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, in particular if this occurs at least a predetermined number of times.
  • the implantable cardioverter defibrillator is configured, if a classification result represents an existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, and the second heart rate data of the patient acquired from the mobile device indicates a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, to check if a patient wellbeing confirmation has been received from the mobile device.
  • This advantageously presents a further security layer in order to prevent erroneous therapy provided by the implantable medical device.
  • the implantable cardioverter defibrillator is configured, if the patient wellbeing confirmation is received from the mobile device within a predetermined time period, to not initiate a ventricular tachycardia and/or ventricular fibrillation therapy, and wherein if the patient wellbeing confirmation is not received from the mobile device within a predetermined time period, to initiate the ventricular tachycardia and/or ventricular fibrillation therapy.
  • the patient thus has the ability to directly influence whether or not therapy is provided by submitting the patient wellbeing confirmation.
  • the implantable cardioverter defibrillator is configured to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if the mobile device does not transmit the second heart rate data of the patient within a predetermined time period after receiving a request by the implantable cardioverter defibrillator.
  • the predetermined time period thus serves as a safety measure allowing the patient to confirm his or her well-being.
  • the implantable cardioverter defibrillator is configured to classify an existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient and to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if both the implantable cardioverter defibrillator and the mobile device detect the ventricular tachycardia and/or ventricular fibrillation episode of the patient.
  • the necessity of therapy provision by the implantable medical device has been verified by a two-factor authentication, namely the first verification by the implantable medical device and the second verification by the mobile device.
  • a classification unit of the implantable cardioverter defibrillator is configurable, activatable and/or deactivatable during implantation or follow-up of the implantable cardioverter defibrillator. This advantageously enables configuration, activation and/or deactivation of the classification unit by a trained healthcare practitioner.
  • the herein described features of the system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient are also disclosed for the method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient and vice versa.
  • Fig. 1 shows a diagram of a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient according to a preferred embodiment of the invention
  • Fig. 2 shows a flowchart of a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient according to the preferred embodiment of the invention.
  • the system 1 shown in Fig. 1 comprises an implantable cardioverter defibrillator 10, configured to acquire first heart rate data DI of the patient.
  • the system 1 comprises a mobile device 12, in particular a wearable device, configured to acquire second heart rate data D2 of the patient, wherein the implantable cardioverter defibrillator 10 is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient using the first heart rate data DI acquired by the implantable cardioverter defibrillator 10 and the second heart rate data D2 acquired by the mobile device 12.
  • Possible classification results are e.g. an existence and a nonexistence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient.
  • further subclasses of the above-mentioned existence and nonexistence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient can further be implemented.
  • an additional class for undetected or undetectable episodes can be provided. Said additional class can be classified e.g. should a classification confidence score of the detected episode be below a predetermined threshold value.
  • the implantable cardioverter defibrillator 10 is configured to detect the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient using at least one detection algorithm A comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm A.
  • Fig. 2 shows a flowchart of a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient according to the preferred embodiment of the invention.
  • the method comprises acquiring first heart rate data DI of the patient by means of an implantable cardioverter defibrillator 10, in particular an implantable cardioverter defibrillator 10, and acquiring second heart rate data D2 of the patient by means of a mobile device 12, in particular a wearable device.
  • the method comprises classifying the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient using the first heart rate data DI acquired by the implantable cardioverter defibrillator 10 and the second heart rate data D2 acquired by the mobile device 12, in particular by the implantable cardioverter defibrillator 10.
  • Fig. 2 hence shows a possible implementation for a procedure based on an active implantable defibrillator implant and a wearable device mobile device that can perform heart rate measurement, where the active implant takes into account the results of the heart rate measurement of the wearable during ventricular tachycardia and/or ventricular fibrillation detection and classification.
  • the patient carries and/or wears a mobile device 12 such as a smartwatch.
  • the mobile device 12 is provided with an app having access to a continuous heart rate measurement of the mobile device 12.
  • the implantable medical device connects to the mobile device 12 by placing a magnet on the skin of the patient in close proximity to the implant. The application of the magnet ensures that no mobile device 12 connects to the implant unintentionally without physical contact to the patient.
  • a magnetic switch in the implant thereby activates the Bluetooth Low Energy interface and sets the implant into a pairing mode which is active for a predetermined time period such as 30 to 60 seconds in order to limit power consumption.
  • the information transmitted between the implantable medical device and the mobile device 12 is, in addition to the security mechanisms of the Bluetooth Low Energy standard, optionally protected by further procedures such as an end-to-end encryption.
  • the implantable cardioverter defibrillator 10 upon detection 16 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, is configured to acquire the second heart rate data D2 of the patient from the mobile device 12, in particular by sending a command C to the mobile device 12 requesting the second heart rate data D2 of the patient.
  • the implantable cardioverter defibrillator 10 comprises a Bluetooth Low Energy interface configured to communicate with the mobile device 12, in particular to acquire the second heart rate data D2 of the patient from the mobile device 12.
  • the implantable cardioverter defibrillator 10 upon detection of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, is configured to control the mobile device 12 to prompt 18 the patient to confirm a wellbeing.
  • the implantable cardioverter defibrillator 10 is configured, if upon detection of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient a classification result represents a non-existence 22 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, in particular if this occurs at least a predetermined number of times, to send a notification 24 to a service provider, in particular a health care provider.
  • the implantable cardioverter defibrillator 10 is further configured, if a classification result represents an existence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, and the second heart rate data D2 of the patient acquired from the mobile device 12 indicates a non-existence 26 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, to check 28 if a patient wellbeing confirmation 14 has been received from the mobile device 12.
  • the implantable cardioverter defibrillator 10 is moreover configured, if the patient wellbeing confirmation 14 is received from the mobile device 12 within a predetermined time period, to not initiate 32 a ventricular tachycardia and/or ventricular fibrillation therapy, and wherein if the patient wellbeing confirmation 14 is not received from the mobile device 12 within a predetermined time period, to initiate 30 the ventricular tachycardia and/or ventricular fibrillation therapy.
  • Reference sign 34 marks the end of the method.
  • the implantable cardioverter defibrillator 10 is in addition configured to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if the mobile device 12 does not transmit the second heart rate data D2 of the patient within a predetermined time period after receiving a request by the implantable cardioverter defibrillator 10.
  • the implantable cardioverter defibrillator 10 is furthermore configured to classify an existence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient and to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if both the implantable cardioverter defibrillator 10 and the mobile device 12 detect the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient.
  • a classification unit of the implantable cardioverter defibrillator 10 is configurable, activatable and/or deactivatable during implantation or follow-up of the implantable cardioverter defibrillator 10.

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Abstract

The invention relates to a system (1) for classifying a ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of a patient, comprising an implantable cardioverter defibrillator (10), configured to acquire first heart rate data (D1) of the patient, and a mobile device (12), in particular a wearable device, configured to acquire second heart rate data (D2) of the patient, wherein the implantable cardioverter defibrillator (10) is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient using the first heart rate data (D1) acquired by the implantable cardioverter defibrillator (10) and the second heart rate data (D2) acquired by the mobile device (12). Furthermore, the invention relates to a computer-implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of a patient.

Description

System and method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient
The invention relates to a system for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient.
Furthermore, the invention relates to a method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient.
DE 20 2016 008 929 U1 discloses a cardioverter defibrillator for suitability determination for the administration of a defibrillator shock, wherein the cardioverter defibrillator is configured to detect a ventricular tachycardia in a subject, obtain an indication of the person's blood pressure, and if the blood pressure is below a predetermined threshold, determine that administration of a defibrillator surge is appropriate.
Conventionally, when a ventricular tachycardia and/or ventricular fibrillation episode of a patient is detected, the implantable defibrillator executes algorithms that perform classification. It is thereby essential to avoid inadequate shocks.
For the correct detection of ventricular tachycardia and/or ventricular fibrillation episodes, currently known methods have the disadvantage that if an electrode of the implantable cardioverter defibrillator is perforated or defective, this may not be detected correctly.
Electrode fractures, perforations, electrode displacements and/or significant impedance changes in a short time are some of the most common reasons for inadequate shock delivery. It is therefore an object of the present invention to provide an improved system and method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient capable of reducing a number of inadequate shocks in active implantable defibrillators.
The object is solved by a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient having the features of claim 1.
Furthermore, the object is solved by a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient having the features of claim 12.
Further developments and advantageous embodiments are defined in the dependent claims.
The present invention provides a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient. The system comprises an implantable cardioverter defibrillator, configured to acquire first heart rate data of the patient.
Furthermore, the system comprises a mobile device, in particular a wearable device, configured to acquire second heart rate data of the patient, wherein the implantable cardioverter defibrillator is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode of the patient using the first heart rate data acquired by the implantable cardioverter defibrillator and the second heart rate data acquired by the mobile device.
The present invention moreover provides a computer-implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient. The method comprises acquiring first heart rate data of the patient by means of an implantable cardioverter defibrillator, in particular an implantable cardioverter defibrillator.
In addition, the method comprises acquiring second heart rate data of the patient by means of a mobile device, in particular a wearable device, and classifying the ventricular tachycardia and/or ventricular fibrillation episode of the patient using the first heart rate data acquired by the implantable cardioverter defibrillator and the second heart rate data acquired by the mobile device, in particular by the implantable cardioverter defibrillator.
Furthermore, the present invention provides a computer program with program code to perform the method of the present invention when the computer program is executed on a computer.
Moreover, the present invention provides a computer-readable data carrier containing program code of a computer program for performing the method of the present invention when the computer program is executed on a computer.
An idea of the present invention is to reduce a number of inadequate shocks in active implantable defibrillators by incorporating reference measurements from a mobile device such as a smartwatch.
When a ventricular tachycardia and/or ventricular fibrillation is detected, a second reference value detected by the mobile device is thus obtained within a predetermined time period. Shock delivery by the implant does not occur until the mobile device has also detected the arithmetic. If the mobile device does not detect the arrhythmia, no immediate shock is delivered. The patient must confirm on the mobile device that he or she is well. If this confirmation does not occur within a predefined period of time, the shock is delivered.
According to an aspect of the invention, the implantable cardioverter defibrillator is configured to detect the ventricular tachycardia and/or ventricular fibrillation episode of a patient using at least one detection algorithm comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm. Thus, an accurate detection of the ventricular tachycardia and/or ventricular fibrillation episode of a patient can be achieved.
According to a further aspect of the invention, the implantable cardioverter defibrillator, upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, is configured to acquire the second heart rate data of the patient from the mobile device, in particular by sending a command to the mobile device requesting the second heart rate data of the patient. Said command advantageously has no direct influence on a diagnosis and therapy function of the implant.
According to a further aspect of the invention, the implantable cardioverter defibrillator comprises a Bluetooth Low Energy interface configured to communicate with the mobile device, in particular to acquire the second heart rate data of the patient from the mobile device. The second heart rate data can thus be accessed any time the implantable medical device detects a ventricular tachycardia and/or ventricular fibrillation episode of the patient.
According to a further aspect of the invention, the implantable cardioverter defibrillator, upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, is configured to control the mobile device to prompt the patient to confirm a wellbeing. Prompting the patient to confirm his or her wellbeing is a further security feature that advantageously contributes to a reduction in inadequate shocks administered by the implantable medical device.
The patient is thus able to influence shock delivery because he or she must confirm his or her wellbeing. If for example the ICD falsely detects a tachycardia due to an electrode rupture, it is a safety feature that the patient confirms whether he or she is doing well or not, so that there is no unintended delivery of therapy by the ICD. In order to confirm his or her wellbeing the patient must then interact with the mobile device in a predetermined manner, e.g., press a predetermined combination of buttons or simply push a button.
According to a further aspect of the invention, the implantable cardioverter defibrillator is configured, if upon detection of the ventricular tachycardia and/or ventricular fibrillation episode of the patient a classification result represents a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, in particular if this occurs at least a predetermined number of times, to send a notification to a service provider. This advantageously contributes to identifying a potential cause for the discrepancy between the detection and classification of the implantable cardioverter defibrillator. According to a further aspect of the invention, the implantable cardioverter defibrillator is configured, if a classification result represents an existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, and the second heart rate data of the patient acquired from the mobile device indicates a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient, to check if a patient wellbeing confirmation has been received from the mobile device. This advantageously presents a further security layer in order to prevent erroneous therapy provided by the implantable medical device.
According to a further aspect of the invention, the implantable cardioverter defibrillator is configured, if the patient wellbeing confirmation is received from the mobile device within a predetermined time period, to not initiate a ventricular tachycardia and/or ventricular fibrillation therapy, and wherein if the patient wellbeing confirmation is not received from the mobile device within a predetermined time period, to initiate the ventricular tachycardia and/or ventricular fibrillation therapy. The patient thus has the ability to directly influence whether or not therapy is provided by submitting the patient wellbeing confirmation.
According to a further aspect of the invention, the implantable cardioverter defibrillator is configured to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if the mobile device does not transmit the second heart rate data of the patient within a predetermined time period after receiving a request by the implantable cardioverter defibrillator. The predetermined time period thus serves as a safety measure allowing the patient to confirm his or her well-being.
According to a further aspect of the invention, the implantable cardioverter defibrillator is configured to classify an existence of the ventricular tachycardia and/or ventricular fibrillation episode of the patient and to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if both the implantable cardioverter defibrillator and the mobile device detect the ventricular tachycardia and/or ventricular fibrillation episode of the patient. This way the necessity of therapy provision by the implantable medical device has been verified by a two-factor authentication, namely the first verification by the implantable medical device and the second verification by the mobile device.
According to a further aspect of the invention, a classification unit of the implantable cardioverter defibrillator is configurable, activatable and/or deactivatable during implantation or follow-up of the implantable cardioverter defibrillator. This advantageously enables configuration, activation and/or deactivation of the classification unit by a trained healthcare practitioner.
The herein described features of the system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient are also disclosed for the method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient and vice versa.
For a more complete understanding of the present invention and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings. The invention is explained in more detail below using exemplary embodiments, which are specified in the schematic figures of the drawings, in which:
Fig. 1 shows a diagram of a system for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient according to a preferred embodiment of the invention; and
Fig. 2 shows a flowchart of a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode of a patient according to the preferred embodiment of the invention.
The system 1 shown in Fig. 1 comprises an implantable cardioverter defibrillator 10, configured to acquire first heart rate data DI of the patient.
Furthermore, the system 1 comprises a mobile device 12, in particular a wearable device, configured to acquire second heart rate data D2 of the patient, wherein the implantable cardioverter defibrillator 10 is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient using the first heart rate data DI acquired by the implantable cardioverter defibrillator 10 and the second heart rate data D2 acquired by the mobile device 12.
Possible classification results are e.g. an existence and a nonexistence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient.
According to an alternative embodiment, further subclasses of the above-mentioned existence and nonexistence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient can further be implemented. Moreover, an additional class for undetected or undetectable episodes can be provided. Said additional class can be classified e.g. should a classification confidence score of the detected episode be below a predetermined threshold value.
The implantable cardioverter defibrillator 10 is configured to detect the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient using at least one detection algorithm A comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm A.
Fig. 2 shows a flowchart of a computer implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient according to the preferred embodiment of the invention.
The method comprises acquiring first heart rate data DI of the patient by means of an implantable cardioverter defibrillator 10, in particular an implantable cardioverter defibrillator 10, and acquiring second heart rate data D2 of the patient by means of a mobile device 12, in particular a wearable device.
In addition, the method comprises classifying the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient using the first heart rate data DI acquired by the implantable cardioverter defibrillator 10 and the second heart rate data D2 acquired by the mobile device 12, in particular by the implantable cardioverter defibrillator 10.
Fig. 2 hence shows a possible implementation for a procedure based on an active implantable defibrillator implant and a wearable device mobile device that can perform heart rate measurement, where the active implant takes into account the results of the heart rate measurement of the wearable during ventricular tachycardia and/or ventricular fibrillation detection and classification.
The patient carries and/or wears a mobile device 12 such as a smartwatch. The mobile device 12 is provided with an app having access to a continuous heart rate measurement of the mobile device 12. The implantable medical device connects to the mobile device 12 by placing a magnet on the skin of the patient in close proximity to the implant. The application of the magnet ensures that no mobile device 12 connects to the implant unintentionally without physical contact to the patient.
A magnetic switch in the implant thereby activates the Bluetooth Low Energy interface and sets the implant into a pairing mode which is active for a predetermined time period such as 30 to 60 seconds in order to limit power consumption.
The information transmitted between the implantable medical device and the mobile device 12 is, in addition to the security mechanisms of the Bluetooth Low Energy standard, optionally protected by further procedures such as an end-to-end encryption.
The implantable cardioverter defibrillator 10, upon detection 16 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, is configured to acquire the second heart rate data D2 of the patient from the mobile device 12, in particular by sending a command C to the mobile device 12 requesting the second heart rate data D2 of the patient. The implantable cardioverter defibrillator 10 comprises a Bluetooth Low Energy interface configured to communicate with the mobile device 12, in particular to acquire the second heart rate data D2 of the patient from the mobile device 12.
The implantable cardioverter defibrillator 10, upon detection of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, is configured to control the mobile device 12 to prompt 18 the patient to confirm a wellbeing.
The implantable cardioverter defibrillator 10 is configured, if upon detection of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient a classification result represents a non-existence 22 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, in particular if this occurs at least a predetermined number of times, to send a notification 24 to a service provider, in particular a health care provider.
The implantable cardioverter defibrillator 10 is further configured, if a classification result represents an existence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, and the second heart rate data D2 of the patient acquired from the mobile device 12 indicates a non-existence 26 of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient, to check 28 if a patient wellbeing confirmation 14 has been received from the mobile device 12.
The implantable cardioverter defibrillator 10 is moreover configured, if the patient wellbeing confirmation 14 is received from the mobile device 12 within a predetermined time period, to not initiate 32 a ventricular tachycardia and/or ventricular fibrillation therapy, and wherein if the patient wellbeing confirmation 14 is not received from the mobile device 12 within a predetermined time period, to initiate 30 the ventricular tachycardia and/or ventricular fibrillation therapy. Reference sign 34 marks the end of the method.
The implantable cardioverter defibrillator 10 is in addition configured to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if the mobile device 12 does not transmit the second heart rate data D2 of the patient within a predetermined time period after receiving a request by the implantable cardioverter defibrillator 10.
The implantable cardioverter defibrillator 10 is furthermore configured to classify an existence of the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of the patient and to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if both the implantable cardioverter defibrillator 10 and the mobile device 12 detect the ventricular tachycardia and/or ventricular fibrillation episode VT, VF of a patient. A classification unit of the implantable cardioverter defibrillator 10 is configurable, activatable and/or deactivatable during implantation or follow-up of the implantable cardioverter defibrillator 10.
Reference Signs
1 System
10 implantable cardioverter defibrillator 12 mobile device
14 patient wellbeing confirmation
16, 18, 20 method steps
22, 24, 26 method steps
28, 30, 32 method steps 34 end of method
C command
DI first heart rate data
D2 second heart rate data
SI -S3 method steps VF ventricular fibrillation
VT ventricular tachycardia

Claims

Claims
1. System (1) for classifying a ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of a patient, comprising: an implantable cardioverter defibrillator (10), configured to acquire first heart rate data (DI) of the patient; and a mobile device (12), in particular a wearable device, configured to acquire second heart rate data (D2) of the patient, wherein the implantable cardioverter defibrillator (10) is configured to classify the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient using the first heart rate data (DI) acquired by the implantable cardioverter defibrillator (10) and the second heart rate data (D2) acquired by the mobile device (12).
2. System of claim 1, wherein the implantable cardioverter defibrillator (10) is configured to detect the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient using at least one detection algorithm (A) comprising a detection counter, a redetection counter and/or a heart rate stability detection algorithm (A).
3. System of claim 1 or 2, wherein the implantable cardioverter defibrillator (10), upon detection of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient, is configured to acquire the second heart rate data (D2) of the patient from the mobile device (12), in particular by sending a command (C) to the mobile device (12) requesting the second heart rate data (D2) of the patient.
4. System of claim 3, wherein the implantable cardioverter defibrillator (10) comprises a Bluetooth Low Energy interface (15) configured to communicate with the mobile device (12), in particular to acquire the second heart rate data (D2) of the patient from the mobile device (12).
5. System of claim 3 or 4, wherein the implantable cardioverter defibrillator (10), upon detection of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient, is configured to control the mobile device (12) to prompt the patient to confirm a wellbeing. System of any one of the preceding claims, wherein the implantable cardioverter defibrillator (10) is configured, if upon detection of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient a classification result represents a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient, in particular if this occurs at least a predetermined number of times, to send a notification to a service provider. System of any one of the preceding claims, wherein the implantable cardioverter defibrillator (10) is configured, if a classification result represents an existence of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient, and the second heart rate data (D2) of the patient acquired from the mobile device (12) indicates a non-existence of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient, to check if a patient wellbeing confirmation (14) has been received from the mobile device (12). System of claim 7, wherein the implantable cardioverter defibrillator (10) is configured, if the patient wellbeing confirmation (14) is received from the mobile device (12) within a predetermined time period, to not initiate a ventricular tachycardia and/or ventricular fibrillation therapy, and wherein if the patient wellbeing confirmation (14) is not received from the mobile device (12) within a predetermined time period, to initiate the ventricular tachycardia and/or ventricular fibrillation therapy. System of any one of the preceding claims, wherein the implantable cardioverter defibrillator (10) is configured to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if the mobile device (12) does not transmit the second heart rate data (D2) of the patient within a predetermined time period after receiving a request by the implantable cardioverter defibrillator (10). System of any one of the preceding claims, wherein the implantable cardioverter defibrillator (10) is configured to classify an existence of the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient and to initiate the ventricular tachycardia and/or ventricular fibrillation therapy if both the implantable cardioverter defibrillator (10) and the mobile device (12) detect the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of a patient. System of any one of the preceding claims, wherein a classification unit of the implantable cardioverter defibrillator (10) is configurable, activatable and/or deactivatable during implantation or follow-up of the implantable cardioverter defibrillator (10). Computer-implemented method for classifying a ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of a patient, comprising the steps of: acquiring (SI) first heart rate data (DI) of the patient by means of an implantable cardioverter defibrillator (10), in particular an implantable cardioverter defibrillator (io); acquiring (S2) second heart rate data (D2) of the patient by means of a mobile device (12), in particular a wearable device; and classifying (S3) the ventricular tachycardia and/or ventricular fibrillation episode (VT, VF) of the patient using the first heart rate data (DI) acquired by the implantable cardioverter defibrillator (10) and the second heart rate data (D2) acquired by the mobile device (12), in particular by the implantable cardioverter defibrillator (10). Computer-implemented method of claim 12, wherein sending a command (C) to the mobile device (12) requesting the second heart rate data (D2) of the patient has no effect on a diagnostic and/or therapeutic function of the implantable cardioverter defibrillator (10). Computer program with program code to perform the method of any one of claims 12 to 13 when the computer program is executed on a computer. Computer-readable data carrier containing program code of a computer program for performing the method of to any one of claims 12 to 13 when the computer program is executed on a computer.
PCT/EP2023/055120 2022-03-17 2023-03-01 System and method for classifying a ventricular tachycardia and/or a ventricular fibrillation episode of a patient WO2023174684A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002002007A1 (en) * 2000-06-30 2002-01-10 Cardiac Science, Inc. A cardiac arrhythmia detector using ecg waveform-factor and its irregularity
US20180116537A1 (en) * 2014-07-07 2018-05-03 Zoll Medical Corporation System and Method for Distinguishing a Cardiac Event From Noise in an Electrocardiogram (ECG) Signal
US20180243578A1 (en) * 2017-02-27 2018-08-30 Zoll Medical Corporation Ambulatory medical device interaction
US20200206520A1 (en) * 2016-02-16 2020-07-02 Chung Wah SIU A method of determining suitability of adminstering defibrillator electric shock and a device thereof
DE202016008929U1 (en) 2016-02-16 2020-10-14 Chung Wah SIU Cardioverter defibrillator and portable blood pressure change monitor therefor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002002007A1 (en) * 2000-06-30 2002-01-10 Cardiac Science, Inc. A cardiac arrhythmia detector using ecg waveform-factor and its irregularity
US20180116537A1 (en) * 2014-07-07 2018-05-03 Zoll Medical Corporation System and Method for Distinguishing a Cardiac Event From Noise in an Electrocardiogram (ECG) Signal
US20200206520A1 (en) * 2016-02-16 2020-07-02 Chung Wah SIU A method of determining suitability of adminstering defibrillator electric shock and a device thereof
DE202016008929U1 (en) 2016-02-16 2020-10-14 Chung Wah SIU Cardioverter defibrillator and portable blood pressure change monitor therefor
US20180243578A1 (en) * 2017-02-27 2018-08-30 Zoll Medical Corporation Ambulatory medical device interaction

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