Failsafe programming of implantable medical devices

• US 9,867,992 B2
• Filed: 01/27/2011
• Issued: 01/16/2018
• Est. Priority Date: 10/31/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sieracki, Jeffrey M., North, Richard B.
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US13/015,230
• Publication Number:
  US 20110125221A1
• Time in Patent Office: 2,546 Days
• Field of Search: 607 60
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G06F 8/61 Installation
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

A watchdog unit receives stay-alive signals from a programming device during programming of an implantable medical device. The watchdog unit maintains a watchdog timer, and resets the timer upon receipt of each stay-alive signal. If the watchdog timer expires, the watchdog unit changes a mode of operation of the implantable device, e.g., places the implantable medical device into a known, safe state. For example, the watchdog unit may cause the implantable medical device to suspend delivery of therapy, perform a power-on reset, and/or recall a known, safe, therapy delivery program.

Claims

1. A method comprising:

sending, by a programming device, a signal to a watchdog unit, the signal indicating the beginning of a programming session, wherein the signal causes the watchdog unit to initialize a watchdog timer in response to receipt of the signal indicating the beginning of the programming session;

sending, by the programming device, programming signals via wireless telemetry to an implantable medical device during the programming session, wherein the programming signals are configured to affect operation of the implantable medical device; and

sending, by the programming device, stay-alive signals to the watchdog unit during the programming session, wherein the stay-alive signals are configured to reset the watchdog timer of the watchdog unit to allow the watchdog unit to detect failure of a wireless telemetry session between a programming device and the implantable medical device during the programming session,

wherein the watchdog unit is configured to detect failure of the wireless telemetry session based on whether the watchdog timer has expired during the programming session, and to output a signal to the implantable medical device to change a mode of operation of the implantable medical device in response to expiration of the watchdog timer.

2. The method of claim 1, further comprising:

sending, by the programming device, a signal to the watchdog unit to indicate the ending of the programming session; and

stopping maintenance, by the watchdog unit, of the watchdog timer in response to receipt of a signal indicating the end of the programming session.

3. The method of claim 1, wherein sending stay-alive signals comprises generating transitions on a data line.

4. The method of claim 1, wherein sending stay-alive signals comprises sending stay-alive signals via the wireless telemetry.

5. The method of claim 1, wherein sending stay-alive signals comprises:

resetting a timer upon delivery of a programming signal; and

sending a stay-alive signal upon expiration of the timer.

6. The method of claim 1, wherein the stay-alive signals are configured to reset the watchdog timer of the watchdog unit upon receipt of both the programming signals and the stay alive signals at the watchdog timer during the programming session.

7. The method of claim 1, wherein sending the stay-alive signals comprises only sending the stay alive signal during the programming session and when no programming signal has been sent during the programming session in time to cause the watchdog unit to reset the watchdog timer.

8. The method of claim 1, wherein sending the programming signals and sending the stay-alive signals comprises sending the programming signals and the stay-alive signals on separate data lines.

9. The method of claim 1, further comprising:

initializing, by the watchdog unit, the watchdog timer in response to receipt of the signal indicating the beginning of the programming session;

maintaining, by the watchdog unit, the watchdog timer only during the programming session; and

stopping maintenance, by the watchdog unit, of the watchdog timer in response to receipt of a signal indicating the end of the programming session.

10. A programming device comprising:

a telemetry circuit configured to communicate via wireless telemetry; and

a processor configured to;

send a signal to a watchdog unit, the signal indicating the beginning of a programming session, the signal configured to initiate a watchdog timer in the watchdog unit in response to receipt of the signal at the watchdog unit;

send programming signals via the wireless telemetry to an implantable medical device during the programming session, wherein the programming signals are configured to affect operation of the implantable medical device; and

send stay-alive signals to the watchdog unit during the programming session, wherein the stay-alive signals are configured to reset the watchdog timer of the watchdog unit to allow the watchdog unit to detect failure of a wireless telemetry session between the programming device and the implantable medical device during the programming session, wherein the watchdog unit is configured to detect failure of the wireless telemetry session based on whether the watchdog timer has expired during the programming session, and to output a signal to the implantable medical device to change a mode of operation of the implantable medical device in response to expiration of the watchdog timer.

11. The programming device of claim 10, wherein the programming device is coupled to a telemetry head by a cable, and wherein the processor sends stay-alive signals by generating transitions on a data line of the cable.

12. The programming device of claim 10, wherein the processor sends stay-alive signals via the wireless telemetry.

13. The programming device of claim 10, wherein the processor resets a timer upon delivery of a programming signal, and sends a stay-alive signal upon expiration of the timer.

14. The device of claim 10, wherein the stay-alive signals are configured to reset the watchdog timer of the watchdog unit upon receipt of both the programming signals and the stay alive signals at the watchdog timer during the programming session.

15. The device of claim 10, wherein the processor is further configured to only send the stay alive signal during the programming session and when no programming signal has been sent during the programming session in time to cause the watchdog unit to reset the watchdog timer.

16. The device of claim 10, wherein the processor is further configured to send the programming signals and the stay-alive signals on separate data lines.

17. The device of claim 10, wherein the watchdog unit is further configured to:

initialize the watchdog timer in response to receipt of the signal indicating the beginning of the programming session;

maintain the watchdog timer during the programming session; and

stop maintenance of the watchdog time in response to receipt of a signal indicating the end of the programming session.

18. A computer-readable storage medium comprising instructions that cause a programmable processor to:

send a signal to a watchdog unit, the signal indicating the beginning of a programming session, the signal configured to initiate a watchdog timer in the watchdog unit in response to receipt of the signal at the watchdog unit;

send programming signals via wireless telemetry to an implantable medical device during the programming session, wherein the programming signals are configured to affect operation of the implantable medical device; and

send stay-alive signals to the watchdog unit during the programming session, wherein the stay-alive signals are configured to reset the watchdog timer of the watchdog unit to allow the watchdog unit to detect failure of a wireless telemetry session between a programming device and the implantable medical device during the programming session, wherein the watchdog unit is configured to detect failure of the wireless telemetry session based on whether the watchdog timer has expired during the programming session, and to output a signal to the implantable medical device to change a mode of operation of the implantable medical device in response to expiration of the watchdog timer.

19. The computer-readable storage medium of claim 18, further comprising instructions that cause the programmable processor to send a signal to the watchdog unit to indicate the ending of the programming session, and to stop maintenance of the watchdog timer in response to receipt of the signal at the watchdog unit indicating the end of the programming session.

20. The computer-readable storage medium of claim 18, wherein the instructions that cause the programmable processor to send stay-alive signals comprise instructions that cause the programmable processor to:

reset a timer upon delivery of a programming signal; and

send a stay-alive signal upon expiration of the timer.