WO2025219257A1 - Système de communication de dispositif médical de faible puissance et dispositifs pour un tel système - Google Patents

Système de communication de dispositif médical de faible puissance et dispositifs pour un tel système

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Publication number
WO2025219257A1
WO2025219257A1 PCT/EP2025/060057 EP2025060057W WO2025219257A1 WO 2025219257 A1 WO2025219257 A1 WO 2025219257A1 EP 2025060057 W EP2025060057 W EP 2025060057W WO 2025219257 A1 WO2025219257 A1 WO 2025219257A1
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WIPO (PCT)
Prior art keywords
data
clinical data
transmission
medical device
imd
Prior art date
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Pending
Application number
PCT/EP2025/060057
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English (en)
Inventor
David Mcintosh
James Horton
Kevin Gehle
Peter Watkins
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.)
Biotronik SE and Co KG
Original Assignee
Biotronik SE and Co KG
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Filing date
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Application filed by Biotronik SE and Co KG filed Critical Biotronik SE and Co KG
Publication of WO2025219257A1 publication Critical patent/WO2025219257A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • A61N1/37254—Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
    • 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
    • A61N1/37276—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by means for reducing power consumption during telemetry
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/10—Protocols in which an application is distributed across nodes in the network
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/12—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
    • H04L67/125—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks involving control of end-device applications over a network
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W40/00—Communication routing or communication path finding
    • H04W40/02—Communication route or path selection, e.g. power-based or shortest path routing
    • H04W40/12—Communication route or path selection, e.g. power-based or shortest path routing based on transmission quality or channel quality
    • 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
    • A61N1/37282—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by communication with experts in remote locations using a network
    • 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
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/2866—Architectures; Arrangements
    • H04L67/30—Profiles
    • H04L67/306—User profiles

Definitions

  • BIOTRONIK SE & Co. KG Applicant: BIOTRONIK SE & Co. KG
  • the invention relates to a low-power medical device communication system (MDCS) for communication between implantable medical devices (IMD) and a remotely located data repository hosting clinical data that has been uploaded from the IMDs for the purpose of remote patient monitoring.
  • MDCS low-power medical device communication system
  • IMD implantable medical devices
  • the invention further relates to an IMD and an IMD battery charger for such a MDCS.
  • IMDs Remote patient monitoring to monitor the health of patients fitted with IMDs and the status of their IMDs is well known.
  • IPG implantable pulse generator
  • SCS spinal cord stimulator
  • ICD implantable cardioverter defibrillator device
  • ILR implantable loop recorder
  • IND implantable neuromodulation device
  • An IMD is implanted in a patient and is configured to upload clinical data on a continual and/or trigger-based basis via a MDCS to a remotely located data repository, which may be a data center.
  • clinical data as an umbrella term to include both patient data relating to physiological monitoring of a patient's health, for example as collected by sensors of the IMD, and device data related to status and operation of the IMD, for example data logging each time an SCS device and/or SCS program is used and at what stimulation level in terms of electrical pulse width, duty cycle, therapy waveform, electrical contacts (anodes/cathodes) and/or pulse frequency.
  • Figure 1 shows a standard architecture of a MDCS for communication between an IMD implanted in a patient and a remotely located data center, which is accessible to health care staff using suitable application software.
  • the IMD 10 includes therapeutic components for patient treatment, such as a stimulator 11, and therapeutic components for patient monitoring, such as a sensor 13.
  • the IMD 10 further comprises chipsets providing computing and telecommunications resource in the form of memory 17, a processor 18 and a low-power wireless personal area network (WPAN) wireless transceiver 12.
  • the IMD 10 is powered by a rechargeable battery 14.
  • the IMD 10 could also be powered by a non- rechargeable battery.
  • the IMD's rechargeable battery 14 of an implanted IMD can be charged in a contactless manner by an inductive charger 20, for example a resonant inductive charger, which is placed on the patient's skin adjacent the implanted IMD 10 to charge its rechargeable battery 14.
  • the charger 20 is itself provided with a rechargeable battery 24 as an electrical energy source as well as an external mains power connection 29 to power the charger 20 so that its rechargeable battery 24 can be recharged.
  • the charger's battery 24 can be recharged wirelessly by placing on a mains-powered charging pad.
  • the IMD local radio 12 uses a suitable WPAN protocol such as Bluetooth Low Energy (BLE), Medical Implant Communication System (MICS), Medical Device Radiocommunications Service (MedRadio), the latter two being almost identical protocols, or proprietary inductive communications in the ⁇ 100 kHz range (e.g. for distances ⁇ 10 cm).
  • BLE Bluetooth Low Energy
  • MIMS Medical Implant Communication System
  • MedRadio Medical Device Radiocommunications Service
  • BLE has an operating frequency band usually quoted as 2.4 GHz but which is more specifically one of the ISM radio bands defined by the ITU Radio Regulations, which occupies the frequency band 2.400 to 2.4835 GHz, i.e. with a bandwidth of somewhat less than 100 MHz.
  • BLE is specified with a nominal maximum range of 100 meters. However, a typical range is likely to be a few tens of meters and possibly considerably less in a building setting (or even less than a few meters in case of deeply implanted device) owing to physical obstructions such as walls and interference sources, as constituted by other consumer and domestic electronic devices.
  • MICS and MedRadio occupy a frequency band between 401- 406 MHz and are very short range with a range of only two meters.
  • the patient is provided with a patient remote controller 30 (patient remote), for example a smartphone with wireless transceivers 32, 35, 36 respectively for WPAN, cellular and WLAN communication.
  • patient remote for example a smartphone with wireless transceivers 32, 35, 36 respectively for WPAN, cellular and WLAN communication.
  • a smartphone is used, this is a smartphone that is possessed, e.g. owned, by the patient in whom the IMD 10 is implanted and on which a software application ('app') is installed.
  • the app is then a so-called Software as a Medical Device (SaMD) which is defined by the United States Food and Drug Administration (FDA) as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
  • SaMD Software as a Medical Device
  • FDA United States Food and Drug Administration
  • the cellular transceiver 35 and WLAN transceiver 36 provide two different data communication paths for the patient remote 30 to upload clinical data from the IMD 10 to a remotely located data center 60 (backend, e.g., Neuro Service Center) acting as a host for the services, for example a neuro data center.
  • the remote's WLAN transceiver 36 can upload data to the backend 60 via a router 38 and telephone line 40 using a wired internet connection.
  • the remote's cellular transceiver 35 can upload data to the backend 60 via one or more cellular network base stations 42 (cellular towers).
  • a dedicated point-to-point transmission e.g. via a dedicated telephone line, may be provided for uploading clinical data.
  • uploading of clinical data from the IMD 10 to the backend 60 takes place via the intermediary of the patient remote 30, the latter thereby acting as a relay device.
  • Health care staff such as health care professionals (HCPs), clinical specialists and representatives and remote care team members have access to the backend 60 via suitable portals 70 with the aid of a software application running on the backend 60 and/or the portal 70 to provide the necessary user interfacing, diagnostics and so forth.
  • HCPs health care professionals
  • portals 70 with the aid of a software application running on the backend 60 and/or the portal 70 to provide the necessary user interfacing, diagnostics and so forth.
  • CPT Current Procedural Terminology
  • an implantable medical device for implanting into a patient, comprising: an electrical energy source; therapeutic components for at least one of patient monitoring and treatment that are powered by the electrical energy source and configured to collect clinical data including at least one of patient data relating to a patient's health (this may be any kind of physiological data) and device data related to status and operation of the implantable medical device; a first wireless transceiver configured to operate according to a wireless personal area network, WPAN, communications protocol to transmit the clinical data using a first data communication path; a second wireless transceiver configured to operate according to a low-power wide- area network, LPWAN, communications protocol to transmit the clinical data using a second data communication path; and a memory and a microprocessor, wherein the memory stores clinical data prior to its transmission and further stores a computer program which when executed on the microprocessor controls activation of each of the first and second wireless transceivers and makes decisions on when and with which of the first and second wireless transceivers clinical data stored in the memory is
  • the performance metrics may include at least one of: availability of the first and second data communication paths, signal strengths of the first and second data communication paths, data security levels of the first and second data communication paths, and expected electrical power consumption of the intended transmission with the first and second wireless transceivers.
  • the clinical data comprises a plurality of types of data items and wherein a decision when a transmission of the clinical data is to be performed is based at least in part on the computer program assigning priority levels to the data items to be transmitted based on their data type, said priority levels including at least a high priority level and a low priority level, wherein items of clinical data with the high priority level are to be transmitted without delay and items of clinical data with the low priority level are stored for later transmission upon a subsequent activation of one of the first and second wireless transceivers.
  • a decision when a transmission of the clinical data is to be performed is based at least in part on how much clinical data is waiting for transmission.
  • the clinical data comprises a plurality of parameters, each of which being associated with a value
  • the computer program is configured to pre-process clinical data for transmission according to a data compression protocol based on keeping a log of the parameters and their values as transmitted in immediately previous transmissions of the clinical data and selecting for transmission only parameters whose values have changed according to the log. To refresh the data, from time to time a complete set of the parameters can be selected for transmission and the log is thereby initialized.
  • the therapeutic components comprise at least one patient treatment device.
  • the patient treatment devices may be one or more of: a pulse generator for an implantable pulse generator; a neurostimulator for spinal cord stimulation ; pulse delivering electrodes for a cardiac pacemaker; pulse delivering electrodes for a cardioverter defibrillator; magnetic field generator for an implantable neuromodulation device; and electrical current generator for an implantable neuromodulation device.
  • the therapeutic components comprise at least one patient monitoring device.
  • the patient monitoring devices may be one or more of: a temperature sensor; a pressure sensor; a pressure and volume sensor (e.g. for heart blood volume sensing); an activity sensor (e.g. piezoelectric or accelerometer); an accelerometer; a microphone (e.g. for cochlear implant); a light sensor (e.g. an optical fiber interferometer, a light attenuation sensor); electrodes for an implantable loop recorder (e.g. for cardiac sensing);’ a cardiac signal sensor; an evoked compound action potential (ECAP) sensor; electrodes and sensing circuitry for ECAPs; electrodes for a (blood sugar level) glucose sensor (e.g. for continuous glucose monitoring); and a blood pressure sensor (e.g. piezoresistive, capacitive, inductive-capacitive, optical transduction).
  • ECAP evoked compound action potential
  • Example WPAN communications protocols supported by the first wireless transceiver include: Bluetooth Low Energy (BLE); Medical Implant Communication System (MICS); Medical Device Radiocommunications Service (MedRadio); Near-Field Communication (NFC); and/or resonant or non-resonant inductive communication, e.g. low power proprietary inductive communications (resonant and non-resonant).
  • Example LPWAN communications protocols supported by the second wireless transceiver include: LTE-M (LTE Advanced for Machine Type Communications), NB-IOT (NarrowBand IOT), IEEE 802.11ah, IEEE 802.15.4a, ISO/IEC 18000-7, and EN13757-4.
  • LPWAN communications protocols appear on the market under various trade names such as LoRa, mioty, Weightless, DASH7, Sigfox, and Wize.
  • a method of uploading clinical data in a medical device communication system utilizing mobile telecommunications network infrastructure that supports a low-power wide-area network, LPWAN, communications protocol comprising: collecting and locally storing clinical data in an implantable medical device having first and second wireless transceivers, wherein the first wireless transceiver is configured to operate according to a wireless personal area network, WPAN, communications protocol and wherein the second wireless transceiver is configured to operate according to said LPWAN communications protocol; and uploading the clinical data from the implantable medical device to a data repository using one of first and second data communication paths between the implantable medical device and the data repository, wherein the first data communication path uses said LPWAN communications protocol to transmit between the implantable medical device and the mobile telecommunications network infrastructure, and the second data communication path uses said WPAN communications protocol to transmit between the implantable medical device and a further device, said further device acting as a relay for onward transmission to the data repository, wherein decisions on when and with which
  • the clinical data may comprise a plurality of types of data items and wherein a decision when a transmission of the clinical data is to be performed is based at least in part on the computer program assigning priority levels to the data items to be transmitted based on their data type, said priority levels including at least a high priority level and a low priority level, wherein items of clinical data with the high priority level are to be transmitted without delay and items of clinical data with the low priority level are stored for later transmission upon a subsequent activation of one of the first and second wireless transceivers.
  • a decision when a transmission of the clinical data is to be performed may be based at least in part on how much clinical data is waiting for transmission.
  • the clinical data may comprise a plurality of parameters, each of which being associated with a value.
  • the computer program is then configured to pre-process clinical data for transmission according to a data compression protocol based on keeping a log of the parameters and their values as transmitted in immediately previous transmissions of the clinical data and selecting for transmission only parameters whose values have changed according to the log. Moreover, to refresh the data 'frame', from time to time a complete set of the parameters is selected for transmission and the log is thereby initialized.
  • Figure 1 is a schematic diagram of a MDCS according to an example standard architecture known in the prior art.
  • Figure 2 is a schematic diagram of a MDCS with IMD according to a first embodiment.
  • Figure 3 is a schematic diagram of a MDCS with IMD and intelligent inductive charger according to a second embodiment.
  • Figure 4 is a schematic diagram of a MDCS with IMD and intelligent inductive charger according to a third embodiment.
  • Figure 5 schematically illustrates various functional units of the IMD as can be used in any of the first to third embodiments.
  • Figure 6 is a flow diagram showing steps of a method of uploading clinical data and acting on downloaded control data in a MDCS according to certain embodiments.
  • ASIC Application Specific Integrated Circuit
  • DSP Digital Signal Processor
  • PLA Programmable Logic Array
  • FPGA field programmable gate array
  • references to a processor should include ASICs including artificial intelligence accelerator ASICs, DSPs, PLAs and FPGAs as well as central processor units (CPUs), graphics processor units (GPUs).
  • references to memory in the following may refer to any one or more of: a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), and a static random access memory (SRAM).
  • References to computer program in the following refer to machine readable program instructions for carrying out operations and may be assembler instructions, instruction-set- architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C#, Python, C++ or the like, and conventional procedural programming languages, such as the "C" programming language or similar programming languages.
  • ISA instruction-set- architecture
  • machine instructions machine dependent instructions
  • microcode firmware instructions
  • state-setting data or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C#, Python, C++ or the like, and conventional procedural programming
  • 4G is the fourth generation of mobile telecommunications technology as defined by the ITU in IMT Advanced, such as LTE (Long Term Evolution).
  • 5G is the fifth generation of mobile telecommunications and wireless technology.
  • UA is part of a UE and acts as a client in a transport protocol for communication with a server.
  • UE is a terminal that resides with the user which hosts a UA
  • WLAN is a wireless local area network standard, for example according to one of the family of IEEE 802.11 standards.
  • LTE- M LTE Cat M
  • NB-loT Narrowband loT
  • NB-loT is marginally more power efficient than LTE-M and that LTE— M allows for cellular tower hand-off LTE-M therefore caters for continuity of communication when traveling from one cellular tower to another, whereas NB-loT does not.
  • NB-loT and LTE-M both provide two power-saving modalities: Power Saving Mode (PSM) and Extended Discontinuous Reception (eDRX).
  • PSM Power Saving Mode
  • eDRX Extended Discontinuous Reception
  • PSM is a modality that enables the device to set sleep and active timers which are then forwarded to the network. If accepted by the network, the network will keep the device registered in the system for the set time. If the device wakes up during this time, no re-attach procedure is needed (detach and re-attach procedures can be very energy consuming). During the sleep interval, the device is not reachable, but the network knows, due to the timers, the next wake-up time of the device and how long it will be active to receive paging messages. It is possible to set a device in a deep sleep mode for up to 14 days.
  • eDRX is a modality that extends the time of the regular discontinuous reception (DRX) modality provided in LTE networks. Regular DRX saves power by allowing a device to switch off its receiver, and thus save power, during periods of inactivity for a time period of up to a few seconds. The extension of DRX to eDRX allows for more extended switch-off times of up to several hours.
  • DRX discontinuous reception
  • a device in the eDRX mode is thus available for paging through mobile terminated services every so often, i.e., over a short period within each eDRX cycle.
  • the device In eDRX mode, the device is reachable once every cycle, so PSM is a synchronous mode.
  • FIG. 2 is a schematic diagram of a MDCS 1 with an IMD 10 and an IMD charger 20 according to a first embodiment.
  • the IMD 10 includes therapeutic components for patient treatment, such as a stimulator 11, and therapeutic components for patient monitoring, such as a sensor 13, as well as chipsets providing computing and telecommunications resource in the form of memory 17, a processor 18 and first and second wireless transceivers 12, 15.
  • the therapeutic components are powered by the electrical energy source 14, which will typically be a battery, more specifically in this embodiment a rechargeable battery. In other embodiments a single-use battery or primary cell battery may be used, i.e., not rechargeable. Alternatively, the electrical energy source need not be a battery. For example, it could be a storage capacitor.
  • the first wireless transceiver 12 is configured to operate according to a low-power WPAN communications protocol, such as BLE, to transmit the clinical data using a first data communication path (illustrated with dot-dashed lines) and optionally also to receive control data from a remotely located data center acting as repository for storage of clinical data, referred to in the following as the backend 60.
  • the second wireless transceiver 15 is configured to operate according to a LPWAN communications protocol to transmit the clinical data using a second data communication path (illustrated with dot-dashed lines) and optionally also to receive control data from the backend 60.
  • the IMD 10 is configured to collect clinical data including at least one of patient data relating to a patient's health and device data related to status and operation of the IMD 10.
  • the clinical data is locally stored in the memory 17 prior to onward transmission to the backend 60.
  • the memory 17 also stores a computer program, i.e. computer readable instructions, which when executed on the processor 18 controls collection, local storage and transmissions of the clinical data, wherein activation of the first and second wireless transceivers 12, 15 is based on the computer program making decisions on when and with which of the first and second wireless transceivers 12, 15 transmissions of the clinical data is to be performed.
  • An electrical charger 20 is provided for wirelessly recharging the IMD battery 14 through induction (e.g., resonant induction, or other options including ultrasound).
  • the charger 20 is itself provided with a rechargeable battery 24 as its electrical energy source as well as an external mains power connection 29 to power the charger 20 so that its rechargeable battery 24 can be recharged.
  • the charger can be recharged wirelessly by placing it on a mains-powered charging pad.
  • the MDCS 1 provides first and second data communication paths from the IMD 10 to the backend 60 as illustrated respectively with dot-dashed and dashed lines.
  • the first data communication path involves direct communication between the IMD 10 and a LPWAN- capable cellular network base station 42, referred to in the following as a cellular tower, using the IMD's LPWAN transceiver 15.
  • the second data communication path involves the IMD's low-power WPAN transceiver 12 (e.g. BLE) transmitting to a WPAN-capable smartphone 30.
  • the smartphone 30 is possessed by the patient in which the IMD 10 is implanted which has a software application ('app') installed acting as SaMD for the IMD 10.
  • the smartphone 30 has wireless transceivers 32, 35, 36 respectively for WPAN, cellular and WLAN communication.
  • the smartphone 30 relays the clinical data it receives from the IMD 10 onwards to the backend 60 in one of two ways.
  • One option for the second data communication path is to use the smartphone's WLAN capability to transmit the signal to a router 38, and the router 38 transmits the clinical data onward via a telephone network 40 to the backend optionally via a distributed network forming cloud services 50.
  • Another option for the second data communication path is to use the smartphone's cellular capability as a user equipment (UE), e.g., using LTE, 4G (4th generation) or 5G (5th generation) protocols, to transmit the clinical data onward to the cellular tower 42 and then to the backend 60 optionally via cloud services 50.
  • UE user equipment
  • the first embodiment thus provides two modes of data communication, there being the first data communication path which uses direct communication from the IMD to the cellular network without any intermediary relay device and the second data communication path which uses an intermediary relay device with the capability of WLAN transmission and/or cellular transmission.
  • the MDCS is thus resilient to outage of the relay device through providing the first data communication path in which the IMD communicates directly with the cellular network.
  • healthcare staff such as healthcare professionals (HCPs), clinical specialists and representatives and remote care team members have access to the backend 60 via suitable workstations 70, referred to as portals, with the aid of a software application running on the backend 60 and/or the portals 70 to provide the necessary user interfacing, diagnostics and so forth for assessment of the clinical data.
  • FIG. 3 is a schematic diagram of a MDCS 1 with IMD 10 and charger 20 according to a second embodiment.
  • the HMD's external charger 20 may be referred to as a wireless-enabled smart charger in that it is provided with low-power WPAN and LPWAN wireless chip sets 22, 25 as well as memory 27 and a processor 28.
  • the MDCS 1 provides first and second data communication paths from the IMD 10 and its smart charger 20 to the backend 60 shown respectively with dot-dashed and dashed lines.
  • the first data communication path involves direct communication between the IMD 10 and optionally also its smart charger 20 and a proximal cellular tower 42 using the respective LPWAN transceivers 15, 25 provided in the IMD 10 and its smart charger 20.
  • the second data communication path involves a smartphone 30 possessed by the patient in whom the IMD is implanted which has a software application ('app') installed acting as SaMD for the IMD.
  • the smartphone 30 has transceivers 32, 34/35, 36 respectively for WPAN, LPWAN/cellular and WPAN communication.
  • the LPWAN and cellular signals may be handled by the same transceiver given that LPWAN utilizes the guard bands of the regular cellular signal using a usual protocol according to 4G, LTE, 5G etc.
  • the respective low-power WPAN transceivers 12, 22 of the IMD 10 and its smart charger 20 transmit to the smartphone 30 which as mentioned above also has a low-power WPAN capability.
  • the smartphone 30 then relays the clinical data onwards in the second data communication path in one of two ways.
  • One option for the second data communication path is to use the smartphone's WLAN to transmit the clinical data to a router 38, and the router 38 transmits the clinical data onward via the telephone network 40 to the backend 60 optionally via cloud services 50.
  • Another option for the second data communication path is to use the smartphone's cellular capability, e.g. LTE, 4G or 5G, to transmit the clinical data onward to the cellular tower 42 and then to the backend 60 optionally via cloud services 50.
  • the second embodiment thus provides two modes of data communication, there being the first data communication path which uses direct communication from the IMD, and optionally also its charger, to the cellular network without any intermediary relay device and the second data communication path which uses a smartphone as an intermediary relay device.
  • FIG. 4 is a schematic diagram of a MDCS 1 with IMD 10 and smart charger 20 according to a third embodiment.
  • the IMD's external charger 20 is a smart charger provided with low-power WPAN, LPWAN and WLAN wireless chip sets 22, 25, 26 as well as memory 27 and a processor 28.
  • the MDCS 1 provides first and second data communication paths from the IMD 10 and its smart charger 20 to the backend 60 illustrated respectively with dot-dashed and dashed lines.
  • the first data communication path involves direct communication between the IMD 10, and optionally also its smart charger 20, and a proximal cellular tower 42 using the respective LPWAN transceivers 15, 25 provided in the IMD 10 and optionally also its smart charger 20.
  • the second data communication path involves the IMD's low-power WPAN transceiver 12 transmitting to a low-power WPAN transceiver 22 of the smart charger 20.
  • Another path for communication between IMD and Charger may be via backscatter communication during the recharging.
  • a signal may be basically part of the power transmission scheme. This is sometimes called Load Shift Keying (LSK), and the data rate is usually low like ⁇ 5 kSymbols/sec.
  • LSK Load Shift Keying
  • the smart charger 20 then relays the signal carrying the patient and device data onwards using the smart charger's WLAN transceiver 26 to transmit the clinical data to a router 38.
  • the router 38 then transmits the clinical data onward via the telephone network 40 to the backend 60 optionally via cloud services 50.
  • the third embodiment thus provides two modes of data communication, there being the first data communication path which uses direct communication from the IMD to the cellular network without any intermediary relay device and the second data communication path which uses the IMD charger as an intermediary relay device using the charger's low-power WPAN to receive the clinical data from the IMD and the charger's WLAN transceiver to transmit the clinical data.
  • the use of the IMD charger as the relay device in the second data communication path has several advantages over use of a smartphone as the relay device, since it is essential for the patient to bring the IMD charger into close proximity with the IMD for charging and also since an intelligent IMD charger of this kind avoids the need to install and operate SaMD as an app on a smartphone.
  • the charger is modified to omit the WLAN transceiver.
  • This variant may be useful if the charger is provided with greater resources than the IMD, e.g. a larger battery than the IMD, or greater computing resources in terms of its memory and/or processor.
  • the second data communication path would then, instead of using WLAN to transmit clinical data from the charger to the router, use the charger's LPWAN transceiver to transmit clinical data from the charger to a proximal cellular tower.
  • the IMD is provided with a battery having sufficient peak current and capacity to provide reasonable performance for its LPWAN cellular radio.
  • a rechargeable lithium- ion battery or battery stack can be used with a capacity of 200-300 mAh and capable of delivering a peak current of between 200 and 900 mApk in short bursts. This battery specification is sufficient when the communication duty cycle is kept low so that average current consumption is very low.
  • the IMD and in some embodiments also its charger, are each provided with a suitable LPWAN transceiver chip set.
  • a suitable system-in-package chip is the Nordic Semiconductor nRF9160 which includes: a cellular modem, a 64 MHz ARM cortex M33 processor, 1MB flash memory, 256kB RAM memory within a package of dimensions 10x16x1.04 mm.
  • the average current consumption of the nRF9160 chip with a supply voltage of 3.7 V and 23 dBm transmission power is: 2.7 pA PSM floor current for both NB- loT and LTE-M; and in eDRX with a cycle length of 655 seconds currents of 9 pA and 6 pA respectively for NB-IoT and LTE-M.
  • the IMD comprises a housing which accommodates the IMD components including an electrical energy supply (battery), a memory, a processor, a LPWAN transceiver and a WPAN transceiver (e.g. BLE radio, MICS radio, MedRadio radio, near-field communication radio) as well as some or all of the therapeutic component features such as a circuit for delivering electrical stimulation energy to a patient, sensors to measure ambient physical parameters or patient-specific physical parameters and so forth.
  • the LPWAN radio may operate according to NB-IoT or LTE Cat M, for example.
  • clinical data to be transmitted in any particular instance may include one or both of patient physiological data and device data.
  • a non-exhaustive list of example patient data obtained from physiological monitoring by the IMD for upload to the backend is any of the following:
  • ECGs electrocardiograms
  • a non-exhaustive list of example device data collected from the IMD is: therapy adherence, charging adherence, stimulator status (hardware and software), battery charge state, lead impedance, magnet detection (used for patient triggered events).
  • therapy adherence therapy adherence
  • charging adherence charging adherence
  • stimulator status hardware and software
  • battery charge state battery charge state
  • lead impedance lead impedance
  • magnet detection used for patient triggered events.
  • the LPWAN is ordinarily in a sleep mode but becomes active sporadically.
  • activity of the LPWAN is triggered asynchronously by an event, which may be an external event or an internal event.
  • An external event can force the LPWAN to wake up through receipt of an external signal, e.g. in the form of a TAU or RAU in PSM mode.
  • An internal event is one triggered by logic within the device hosting the LPWAN transceiver.
  • An example external event would be when software running on the backend decides that clinical data must be received, e.g. owing to a long wait since the last clinical data was received.
  • An example internal event would be when software running on the processor decides there is an urgent need to transmit patient data or device data to the backend, e.g. when a monitored physiological parameter goes outside a safe range.
  • Event triggered activity of the LPWAN can be termed asynchronous.
  • activity of the LPWAN may occur synchronously at pre-set time intervals, typically regular time intervals, such as once or twice a day, this being suitable for routine transmission of clinical data which does not have a high priority.
  • eDRX mode may be used for this.
  • the LPWAN protocol distributes the timings of the activity among the network nodes, IMD, user equipment etc. so these are known in advance. For example, there may be daily periods of activity at a set time of day, e.g., every day starting at 11 :00.
  • the IMD communicates clinical data to a backend for remote patient monitoring, with the communication taking place either asynchronously following event triggers, or synchronously at regular intervals, or a combination of both.
  • the IMD may receive data from the backend.
  • the IMD may be configured to be responsive to remote commands that configure patient therapy or set sensing parameters.
  • the IMD may incorporate a switched-mode power supply (SMPS) to step-up or step-down the voltage supplied by the battery to the other components of the IMD.
  • the SMPS may include both a buck-boost converter and a switched capacitor converter and which is used may be selectable, e.g. based on load characteristics. For example, the buck-boost converter may be selected when the LPWAN is active and the switched capacitor converter may be selected for PSM mode.
  • Inductor based Boost, Buck and buck-boost are generally most efficient at higher loads such as when LPWAN (cellular) loads are required.
  • a charge pump (switched capacitor) may provide higher efficiency. So based on the peak and average consumption an optimal switch mode converter may be used to minimize power consumption.
  • PWM pulse width modulation
  • PSM Pulse Skipping Modulation
  • the IMD may be provided with an embedded-SIM (eSIM), for example in the processor or in another chip of the IMD chipset, such as an application-specific integrated circuit (ASIC).
  • eSIM embedded-SIM
  • ASIC application-specific integrated circuit
  • the IMD may also contain a global navigation satellite system (GNSS), such as GPS, Baidu or Galileo through provision of a suitable radio and antenna for geolocating the IMD.
  • GNSS global navigation satellite system
  • the GNSS data is provided to the processor to trigger location-specific transmission.
  • it may be useful to transmit data as the patient is attending the clinic, which may be implemented by detecting coordinates geofenced to a clinic to trigger data transmission.
  • Such a geofencing concept may cover also cases like when a patient is moving more outside their home, this may be a type of physiological signal that the patient’s activity is increasing. In other words, the act of moving around is a kind of physiological measure of patient activity and wellness.
  • GPS may provide information about speed (like it does in the car) for such a differentiation.
  • FIG. 5 schematically illustrates how the IMD 10 includes various functional units within its programmed configuration to assist and control data transmission, these being a transmission path allocation unit 80, a data prioritization unit 82 and a data compression unit 84. These functional units can be used in any of the above embodiments individually or in any combination.
  • TRANSMISSION PATH ALLOCATION UNIT a transmission path allocation unit 80, a data prioritization unit 82 and a data compression unit 84.
  • the IMD processor includes a transmission path allocation unit which has the role of determining which transmission path is optimum for the present circumstances in terms of relevant factors such as power consumption and signal strength. Selection of the transmission path may be made based on a score derived from a factor-weighting table created in advance.
  • a simple example is to select either LPWAN or a local wireless signal, such as BLE, based on the larger of the sum of A plus B where:
  • A is:
  • No connection may mean the logical extreme of the protocol weighting, where a zero is scored if a protocol is not available at all.
  • Another simple scheme is to attempt transmission via a local wireless signal, such as BLE, and upon failure switch to LPWAN using the cellular network.
  • Selection of the transmission path may also depend on properties of the clinical data to be transmitted, for example: clinical importance or urgency of the clinical data; amount or size of clinical data; and receipt of a signal from the backend indicating an urgent requirement to receive more clinical data based on the data set already uploaded to the backend.
  • the data transmission path determination can be done via analysis of labeled operational data over a period of time via a supervised learning algorithm, or via a routing algorithm specific to this application.
  • a routing algorithm is a procedure that lays down the route or path to transfer data packets from source to the destination during transmission, i.e., after a data packet leaves its source, it can choose among the many different paths to reach its destination.
  • Geolocation data may also be incorporated in the selection, e.g., to give a stronger weighting towards the local wireless signal when the IMD is at a known home location or a known work location.
  • the IMD is configured to set priorities for transmitting data items based on multiple factors so it is decided whether transmission of the data items can be delayed or should be sent immediately.
  • the data prioritization may be set via a look-up table. Relevant factors for prioritization may, for example, include:
  • the clinical data item has an age-related priority parameter that is incremented so that when clinically non-urgent data is selected for upload in the next pre-planned time window the oldest such data is given priority;
  • the IMD memory • how much clinical data stored in the IMD memory is ready for transmission. For example, to make a transmission of clinical data that contains no data items with a high clinical priority, it may be a requirement that at least a threshold amount of data is ready for transmission (e.g. at least 1 kB of data), since the minimum energy usage associated with activation of the wireless transceiver and a data transmission of even a small amount of data is significant. Another example would be that an immediate transmission can be triggered, i.e., asynchronously, if the IMD memory is full or is predicted to become full in the near future, e.g., based on a memory fill factor of 80% being reached.
  • a threshold amount of data e.g. at least 1 kB of data
  • an immediate transmission can be triggered, i.e., asynchronously, if the IMD memory is full or is predicted to become full in the near future, e.g., based on a memory fill factor of 80% being reached.
  • the IMD data prioritization can be configured via local or remote programming.
  • the IMD data prioritization can also be amended by clinical staff members based on clinical decisions taken after analysis of the clinical data from the patient's IMD stored at the backend.
  • the IMD data prioritization may also be reconfigured from time to time on an automatic basis applying an algorithm of needs related to remote patient monitoring. Automatic updating and configuration of the data prioritization may also be performed by e.g., a deep learning artificial intelligence program
  • Example Data prioritization Table Use 1 A care team member monitoring a patient via a user portal to access the backend comes to know that a patient’s IMD charging adherence is consistently good, so it no longer needs to be closely monitored. The care team member therefore unchecks a box in the portal indicating the need for receiving clinical data in real-time, i.e. as and when the clinical data is collected. The backend then transmits a message to the IMD, so the IMD knows that clinical data transmissions can be reduced in priority such that asynchronous data transmission is no longer routinely needed and, for example, daily transmission at an allotted time of day is sufficient.
  • the logic in the IMD itself may nevertheless determine that certain clinical data items require asynchronous data transmission based on clinical importance, e.g., adverse patient health indicator, failure or predicted failure of some functionality of the IMD, or other factors as discussed above.
  • a portal user e.g a care team member, may select to be notified about therapy adherence data which exceeds a certain threshold or bound, or goes out of a certain range.
  • the care team member may want to be informed immediately relating to therapy adherence of an SCS trial, after a patient has adjusted the stimulation amplitude or altered the therapy program a significant number of times (e.g. 10) in the current day.
  • the portal user would enable this type of device data to be transmitted asynchronously through an event trigger. Subsequently, every patient adjustment of amplitude would cause an alert message to be sent immediately, i.e. asynchronously, from the IMD to the backend as it occurs using LPWAN.
  • the latency of the upload may be of the order of minutes up to an hour.
  • other patient and device data could still be sent on a once- a-day basis at the allotted transmission time using either LPWAN or WPAN as determined by the IMD's transmission path allocation unit.
  • Figure 6 is a flow diagram showing steps of a method of uploading clinical data and acting on downloaded control data in a MDCS 1 as described above.
  • the data transmission method utilizes mobile telecommunications network infrastructure that supports a LPWAN communications protocol, such as LTE-M or NB-IoT.
  • Step SI clinical data accumulates, i.e. is collected from the IMD and locally stored in the IMD memory.
  • the locally stored clinical data is monitored and the items of data, such as physical parameters with discrete or scalar values, are classified according to one of a plurality of priority levels. In the simplest case, this is a binary classification between urgent and nonurgent data items. In other cases, 3 or more priority levels could be applied or multiple classification types could be created, such as two classification types which are both binary thus creating 4 permutations for the overall data item classification.
  • Step S3 the IMD assesses control data it may from time to time be received, i.e. downloaded, from a remote source such as the backend.
  • the control data may be of a type that causes the IMD to reconfigure a setting of the IMD's therapeutic components, e.g. patient-accessible ranges of pulse width and pulse frequency in an SCS trial. In this case reconfiguration of the IMD is undertaken in Step S4.
  • the control data may also be of a type that controls upload of clinical data, e.g. PSM mode TAU or RAU signals to externally trigger an asynchronous upload of clinical data which is dealt with in Step S5 as follows.
  • Step S5 based on the ongoing monitoring of the priority-classified locally stored clinical data and any external trigger received in control data (Step S3), it is evaluated on an ongoing basis whether or not to initiate a clinical data transmission. If 'no', then the ongoing data accumulation and classification continues.
  • Step S6 the data path for the upload is selected, i.e. it is decided which of the IMD's wireless transceivers is to be used.
  • Step S7 the clinical data is uploaded from the IMD using the selected one of the data communication paths, i.e. using either LPWAN or WPAN for the first segment of the data communication path from the IMD.
  • the method then repeats as the clinical data is once more allowed to accumulate in the local storage while at the same time being monitored and prioritized according to the above-mentioned classification process so that it can then be decided whether an immediate upload is needed based on factors such as the priority classification, accumulated data volume and so forth as described elsewhere in this document. It will also be understood that in some cases all the accumulated clinical data is uploaded whereas in other cases only some of the clinical data is uploaded, for example only the data items with higher priority levels and optionally also further data to ensure a minimum amount of data is sent in the upload, e.g. for most efficient energy management of the IMD battery.
  • the IMD is configured with a data compression scheme.
  • the clinical data comprises a plurality of parameters, each of which is associated with a parameter value.
  • a temporal compression unit is configured such that messages only transmit clinical data items which have changed.
  • the clinical data for transmission is pre-processed according to a data compression protocol.
  • a log is maintained of the parameters and their values as transmitted in immediately previously transmitted messages.
  • the pre-processing selects for transmission only parameters whose values have changed according to the log. From time to time, e.g. periodically, a message is sent containing a complete data set, including parameters whose values have not changed, thereby to resynchronize or initialize the data stream.
  • An implementation of the present disclosure may take the form of or incorporate a computer program product embodied in one or more computer-readable storage medium(s) (e.g., memory) having computer-readable program code embodied or stored thereon.
  • Program code embodied on a computer-readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, radio frequency (RF), etc., or any suitable combination thereof.
  • Cloud computing is a model of service delivery for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, network bandwidth, servers, processing, memory, storage, applications, virtual machines, and services) that can be rapidly provisioned and released with minimal management effort or interaction with a provider of the service.
  • This cloud model may include at least five characteristics, at least three service models, and at least four deployment models.
  • On-demand self-service a cloud consumer can unilaterally provision computing capabilities, such as server time and network storage, as needed automatically without requiring human interaction with the service’s provider.
  • Resource pooling the provider’s computing resources are pooled to serve multiple consumers using a multi-tenant model, with different physical and virtual resources dynamically assigned and reassigned according to demand. There is a sense of location independence in that the consumer generally has no control or knowledge over the exact location of the provided resources but may be able to specify location at a higher level of abstraction (e.g., country, state, or datacenter).
  • Rapid elasticity capabilities can be rapidly and elastically provisioned, in some cases automatically, to quickly scale out and rapidly released to quickly scale in. To the consumer, the capabilities available for provisioning often appear to be unlimited and can be purchased in any quantity at any time.
  • Measured service cloud systems automatically control and optimize resource use by leveraging a metering capability at some level of abstraction appropriate to the type of service (e.g., storage, processing, bandwidth, and active user accounts). Resource usage can be monitored, controlled, and reported, providing transparency for both the provider and consumer of the utilized service.
  • level of abstraction appropriate to the type of service (e.g., storage, processing, bandwidth, and active user accounts).
  • SaaS Software as a Service: the capability provided to the consumer is to use the provider’s applications running on a cloud infrastructure.
  • the applications are accessible from various client devices through a thin client interface such as a web browser (e.g., web-based e-mail).
  • a web browser e.g., web-based e-mail
  • the consumer does not manage or control the underlying cloud infrastructure including network, servers, operating systems, storage, or even individual application capabilities, with the possible exception of limited user-specific application configuration settings.
  • PaaS Platform as a Service
  • the consumer does not manage or control the underlying cloud infrastructure including networks, servers, operating systems, or storage, but has control over the deployed applications and possibly application hosting environment configurations.
  • Private cloud the cloud infrastructure is operated solely for an organization. It may be managed by the organization or a third party and may exist on-premises or off-premises.
  • Public cloud the cloud infrastructure is made available to the general public or a large industry group and is owned by an organization selling cloud services.
  • Hybrid cloud the cloud infrastructure is a composition of two or more clouds (private, community, or public) that remain unique entities but are bound together by standardized or proprietary technology that enables data and application portability (e.g., cloud bursting for load-balancing between clouds).
  • a cloud computer system is service oriented with a focus on statelessness, low coupling, modularity, and semantic interoperability.
  • An infrastructure that includes a network of interconnected nodes.
  • MDCS/MICS I Medical Device/Implant Communication System
  • IMD Implantable Medical Device
  • IMD wireless personal area network (WPAN) transceiver e.g. BLE
  • WPAN wireless personal area network
  • BLE BLE
  • UE user equipment
  • smartphone user equipment
  • patient remote controller patient remote
  • WiPAN wireless personal area network
  • BLE Bluetooth wireless personal area network

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Abstract

L'invention concerne un dispositif médical implantable, IMD, pour la surveillance ou le traitement d'un patient qui collecte des données cliniques à téléverser vers un centre de données distant. L'IMD est équipé d'un premier émetteur-récepteur sans fil configuré pour fonctionner selon un protocole de communication de réseau personnel sans fil, WPAN, pour transmettre les données cliniques à l'aide d'un premier trajet de communication de données et d'un second émetteur-récepteur sans fil configuré pour fonctionner selon un protocole de communication de réseau étendu à faible puissance, LPWAN, pour transmettre les données cliniques à l'aide d'un second trajet de communication de données. L'IMD est pourvu d'une ressource informatique pour décider quand transmettre les données cliniques collectées par l'IMD et avec lequel du premier et du second émetteur-récepteur sans fil, ceci étant effectué en comparant des métriques de performance entre le premier et le second trajet de communication de données, telles que : la disponibilité, l'intensité relative du signal, le niveau de sécurité des données et la consommation d'énergie électrique prédite respective par le premier et le second émetteur-récepteur.
PCT/EP2025/060057 2024-04-18 2025-04-11 Système de communication de dispositif médical de faible puissance et dispositifs pour un tel système Pending WO2025219257A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1583585B1 (fr) * 2002-04-22 2008-06-25 Medtronic, Inc. Communication en continu entre un dispositif medical implantable et un systeme a distance
US20080262573A1 (en) * 2004-08-09 2008-10-23 Cardiac Pacemakers, Inc. Dynamic telemetry link selection for an implantable device
US8401659B2 (en) * 2008-01-15 2013-03-19 Cardiac Pacemakers, Inc. Implantable medical device with wireless communications

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1583585B1 (fr) * 2002-04-22 2008-06-25 Medtronic, Inc. Communication en continu entre un dispositif medical implantable et un systeme a distance
US20080262573A1 (en) * 2004-08-09 2008-10-23 Cardiac Pacemakers, Inc. Dynamic telemetry link selection for an implantable device
US8401659B2 (en) * 2008-01-15 2013-03-19 Cardiac Pacemakers, Inc. Implantable medical device with wireless communications

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