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EP-4525978-B1 - SYSTEM COMPRISING AN IMPLANTABLE MEDICAL DEVICE AND AN EXTERNAL DEVICE

EP4525978B1EP 4525978 B1EP4525978 B1EP 4525978B1EP-4525978-B1

Inventors

  • TAFF, Brian M.
  • MCMILLAN, BRAD
  • MILLER, DAVID

Dates

Publication Date
20260506
Application Date
20230426

Claims (15)

  1. An external device (60) configured to communicate with an implantable medical device (40) implanted within a patient's (30) body using a communication unit (62), wherein the external device (60) further comprises a processor (61), at least one proximity sensor (64) and at least one motion sensor (63), which is configured to detect whether the external device moves and to provide a respective motion signal, wherein the external device (60) is movable with regard to the patient's body to find and establish a communication connection (50) of the communication unit and the implantable medical device, wherein the communication unit (62), the at least one proximity sensor (64) and the at least one motion sensor (63) are electrically connected to the processor (61), wherein the processor (61) is configured to assess the current motion signal of the at least one motion sensor if a signal received from the at least one proximity sensor (64) indicated that the external device (60) is located near the patient's body and/or near the implantable medical device (40) and to provide a movement guidance information based on the assessment of the current motion signal of the at least one motion sensor.
  2. The external device of claim 1, wherein the processor (61) is configured to suspend assessing the current motion signal of the at least one motion sensor (63) and/or to provide a communication confirmation information to the user after the communication unit (62) received a pre-defined response signal from the implantable medical device (40) indicating that a communication connection with the implantable medical device (40) was established.
  3. The external device of any of the previous claims, wherein the processor (61) is configured to provide a position change information to the user requesting the user to change the position after a first pre-defined time period elapsed after starting the process of finding the communication connection (50) and/or after a second pre-defined time period elapsed after a signal received from the at least one proximity sensor (64) indicated that the external device (60) is located near the patient's body and/or near the implantable medical device (40).
  4. The external device of any of the previous claims, wherein the movement guidance information and/or the communication confirmation information and/or the position change information is an information that is haptically and/or optically and/or audibly perceptible by the user.
  5. The external device of any of the previous claims, wherein the at least one proximity sensor (64) comprises an optical sensor and/or an inductive sensor and/or a sensor using radar, sonar and/or ultrasound.
  6. The external device of any of the previous claims, wherein the processor (61) is configured to trigger transition of the communication unit (62) from a sleep mode into an active mode if a signal received from the at least one proximity sensor indicated that the external device is located near the patient's body and/or near the implantable medical device.
  7. An operation method of an external device (60) configured to communicate with an implantable medical device (40) implanted within a patient's (30) body using a communication unit (62), wherein the external device further comprises a processor (61), at least one proximity sensor (64) and at least one motion sensor (63), which detects whether the external device moves and provides a respective motion signal, wherein the external device (60) is movable with regard to the patient's body to find and establish a communication connection (50) of the communication unit (62) and the implantable medical device (40), wherein the communication unit (62), the at least one proximity sensor (64) and the at least one motion sensor (63) are electrically connected to the processor (61), wherein the processor (61) assesses the current motion signal of the at least one motion sensor if a signal received from the at least one proximity sensor (64) indicated that the external device (60) is located near the patient's (30) body and/or near the implantable medical device (40) and provides a movement guidance information based on the assessment of the current motion signal of the at least one motion sensor (64).
  8. The method of claim 7, wherein the processor (61) suspends assessing the current motion signal of the at least one motion sensor (64) and/or provides a communication confirmation information after the communication unit (62) received a pre-defined response signal from the implantable medical device indicating that a communication connection (50) with the implantable medical device was established.
  9. The method of any one of the claims 7 to 8, wherein the processor (61) provides a position change information requesting to change the position after a first pre-defined time period elapsed after starting the process of finding the communication connection and/or after a second pre-defined time period elapsed after a signal received from the at least one proximity sensor indicated that the external device is located near the patient's body and/or near the implantable medical device (40).
  10. The method of any one of the claims 7 to 9, wherein the movement guidance information and/or the communication confirmation information and/or the position change information is an information that is haptically and/or optically and/or audibly perceptible by a user.
  11. The method of any one of the claims 7 to 10, wherein the at least one proximity sensor (64) detects optical signals and/or electromagnetic signals and/or radar, sonar and/or ultrasound signals.
  12. The method of any one of the claims 7 to 11, wherein the processor (61) triggers transition of the communication unit (62) from a sleep mode into an active mode if a signal received from the at least one proximity sensor indicated that the external device (60) is located near the patient's body and/or near the implantable medical device (40).
  13. A computer program product comprising instructions which, when executed by the processor of the external device according to any of claims 1 to 6, cause the processor (61) to perform the steps of the method according to any of the claims 7 to 12.
  14. Computer readable data carrier storing a computer program product according to claim 13.
  15. System comprising an implantable medical device (40) and the external device (60) of any of the claims 1 to 6.

Description

The invention is directed to a system comprising an implantable medical device (IMD) and an external device configured to communicate with the implantable medical device as well as to a respective external device, and an operation method of such external device. The invention is further directed to respective computer program product and a respective computer readable data carrier. Usually, a medical device, in particular, an implantable medical device, is configured to monitor the health status of a patient and/or to deliver a therapy signal to the patient. Active and passive implantable medical devices (IMDs, implants) are, for example, a pacemaker (with leads), an implantable cardiac monitor (ICM), an Implantable Leadless Pacer (ILP), an Implantable Leadless Pressure Sensor (ILPS), an Implantable Cardiac Defibrillator (ICD) or a Subcutaneously Implanted Cardiac Defibrillator (S-ICD), and a device that delivers spinal cord stimulation (SCS), deep brain stimulation (DBS) or neurostimulation. Such IMD may deliver one or more therapeutic substances, (e.g., a drug pump), may contain sensors that collect physiological signals to monitor the health status of the patient and/or deliver a therapy to the patient, for example using electromagnetic waves or electrical output. Such collected signals or therapy information may be transmitted as data to an external device (e.g., smartphone, computer, remote server or wand) using a communication unit, wherein the external device is an end station or a relay station which is located at least partly extracorporeally. The data collected from the various sensors of the IMD can include, but are not limited to, ECG, impedance, activity, posture, heart sounds, pressure, respiration data and other data. Usually, such IMD comprises a processor for data processing and a communication unit configured to bi-directionally exchange signals with a communication unit of the external device. Accordingly, the communication unit of the external device is configured for bidirectional signal exchange with the communication unit of the IMD. The communication unit of the external device, for example, produces and sends signals to the transceiver module of the IMD in form of requests, for example for receiving data concerning the health status of the patient or IMD status from the IMD or for programming (e.g., to configure the IMD to apply appropriate therapies to the patient). Additionally, the external device may provide an electromagnetic field for wireless power transfer to charge a rechargeable battery of the IMD, for example using inductive or capacitive coupling. In some cases the communication unit of the IMD is operated in an active mode and in a sleep mode to reduce energy consumption. A pre-defined signal provided by the communication unit of the external device triggers switching of the communication unit of the IMD from the sleep mode into the active mode (so-called wake up). As IMD sizes continue to shrink at a rate that outpaces the ability for battery capacity densities to improve, the use of low-power circuitry plays an increasingly central role in supporting product service time needs. Unfortunately, developing and incorporating low-power circuitry often involves making trade-offs where lower-frequency on-board clock operation and the reduction in power used to drive subsystem components cause them to run slower through compromised start-up and configuration management times. An area where this provides a direct potential consequence for a user (e.g., a patient or technician or a health care practitioner (HCP) such as a doctor or a nurse) with such products involves the establishment of a communication link by the external device. Such external device used for data exchange, for recharging of secondary cells, or otherwise have often included LED indicators to report when communication is functional but have not incorporated any sophistication to assess when the external device has made contact with the IMD. Moving the external device too quickly or in ways that sweep it out of a position where it has sent a wake-up cue to the IMD but is now out of range for receiving a response prolong the startup of viable information and/or power exchange with the IMD. Presently the external device offers feedback/reporting of whether or not communication is "good" (i.e., has a sufficient signal strength) with the underlying IMD but if any substantial delay in "bringing up" the IMD is in effect, and if the user is accustomed to moving the external device about in search of the IMD, the response from the IMD may occur after the external device has moved out of range to facilitate its receipt. In document US 2020/0178802 A1 a system and a method for improving the security of an operation for writing the memory of an active implantable medical device by long distance telemetry, in particular via network connection with a writing main device, is described. The system and method comprise an inte