Failsafe programming of implantable medical devices

• US 7,899,546 B2
• Filed: 02/27/2008
• Issued: 03/01/2011
• Est. Priority Date: 10/31/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sieracki, Jeffrey M., North, Richard B.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US12/038,364
• Publication Number:
  US 20080147145A1
• Time in Patent Office: 1,098 Days
• Field of Search: 607/60
• US Class Current: 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:

receiving stay-alive signals from a programming device at a watchdog unit coupled to the programming device during a programming session between the programming device and an implantable medical device;

resetting a watchdog timer maintained by the watchdog unit in response to receipt of each of the stay-alive signals; and

sending a signal from the watchdog unit to the implantable medical device via wireless telemetry to cause the implantable medical device to revert to a program previously stored within a memory of the implantable medical device in response to expiration of the watchdog timer.

2. The method of claim 1, wherein receiving stay-alive signals comprises detecting transitions on a data line that couples the watchdog unit to the programming device.

3. The method of claim 1, wherein receiving stay-alive signals comprises receiving stay-alive signals via wireless telemetry.

4. The method of claim 1, wherein receiving stay-alive signals comprises receiving programming signals and stay-alive signals, and resetting a watchdog timer comprises resetting the watchdog timer in response to each of the programming signals and stay-alive signals.

5. The method of claim 1, further comprising:

receiving a signal at the watchdog unit, from the programming device, that indicates initiation of a programming operation; and

initializing the watchdog timer in response to the signal.

6. The method of claim 1, further comprising:

receiving, at the watchdog unit, power from the programming device;

detecting, at the watchdog unit, a failure of power delivery by the programming device;

activating an auxiliary power source of the watchdog unit in response to the detection; and

changing the mode of operation of the implantable medical device using the watchdog unit in response to the detection.

7. A system comprising:

an implantable medical device; and

a watchdog unit to receive stay-alive signals during a programming session with the implantable medical device, reset a watchdog timer maintained by the watchdog unit in response to receipt of each of the stay-alive signals, and send a signal to the implantable medical device via wireless telemetry to cause the implantable medical device to revert to a program previously stored within a memory of the implantable medical device in response to expiration of the watchdog timer.

8. The system of claim 7, further comprising a programming device and a cable, wherein the watchdog unit is coupled to the programming device via a data line of the cable, and receives stay-alive signals from the programming device by detecting transitions on the data line.

9. The system of claim 7, further comprising a programming device, wherein the watchdog unit receives a signal from the programming device that indicates initiation of a programming operation, and initializes the watchdog timer in response to the signal.

10. The system of claim 7, further comprising a programming device, wherein the watchdog unit receives power from the programming device, the watchdog unit further comprising an auxiliary power source, and

wherein the watchdog unit detects a failure of power delivery by the programming device, activates the auxiliary power source in response to the detection, and sends a signal to the implantable medical device via wireless telemetry to cause the implantable medical device to revert to the program previously stored within the memory of the implantable medical device in response to the detection.

11. The system of claim 7, wherein the watchdog unit further comprises a user interface, receives an emergency-off signal in response to interaction of a user with the user interface, and sends a signal to the implantable medical device via wireless telemetry to cause the implantable medical device to revert to the program previously stored within the memory of the implantable medical device in response to receipt of the signal.

12. The system of claim 7, wherein the implantable medical device comprises an implantable neurostimulator.