Method and a system for conducting failure mode recovery in an implanted medical device

• US 6,665,565 B1
• Filed: 12/06/2000
• Issued: 12/16/2003
• Est. Priority Date: 12/24/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ringold, Jean K., Stomberg, Charles R., Stauffer, Ronald A.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/731,222
• Time in Patent Office: 1,105 Days
• Field of Search: 607/30-32, 607/59, 607/60, 128/903, 128/904, 128/899
• US Class Current: 607/31
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G10L 2015/228 of application context

Abstract

A method and a system for conducting failure mode recovery of an implanted medical device. The embodiments described reduce the risk of leaving an IMD in an undesirable state when conditions during programming of the IMD unexpectedly change. In an example embodiment, failure mode recovery in an implanted device is facilitated when a communications link with a medical communications system having an application program is interrupted. The failure mode recovery method includes establishing a communications link between the medical communications system and an extender module configured to receive an application proxy from the application program. An application proxy is then loaded into the extender module via the application program. The application proxy is configured to transition the implanted device to a recovery state in response to a set of conditions. The implanted device then transitions to a completed state via the application program, while transitioning of the completed state is monitored. The implanted device is automatically restored by the application proxy to the recovery state when the set of conditions is detected while transitioning to the completed state.

Claims

1. A method for conducting failure mode recovery in an implantable medical device upon interruption of communications with the implantable medical device, the method comprising:

(a) establishing a communications link between a remote medical communications system having a programming application program and a programming extender module configured to receive an application proxy from the application program;

(b) loading the application proxy into the programming extender module;

(c) transitioning the implantable medical device to a known recovery state in response to an interruption of a communications with the implantable medical device;

(d) transitioning the implantable medical device to a predetermined completed state;

(e) monitoring transition of the implantable medical device to the predetermined completed state; and

(f) automatically restoring the implantable medical device to the known recovery state by the application proxy if an interruption of communications with the implantable medical device is detected while transitioning to the completed state.

2. The method of claim 1, further comprising the step of automatically re-establishing the communications link with the implantable medical device by repeating steps (a) and (b) after an interruption of communications with the implantable medical device has been detected.

3. The method of claim 2, further comprising the step of establishing a voice communications link with a patient having the implantable medical device at the programming extender module before step (a).

4. The method of claim 1, wherein the restoring step includes the steps of:

performing downlink transmission commands that transition the implanted device out of a programming mode;

monitoring the communications link for changes in status; and

reporting changes in status of the communications link via a user Interface.

5. The method of claim 4, further comprising the step of displaying messages via the user interface on actions performed by the application proxy.

6. The method of claim 4, further comprising the step of reconfiguring the application proxy via the user interface.

7. The method of claim 1, wherein the monitoring step includes the steps of:

validating a communications connection with the remote medical communications system;

validating a set of initialization steps for programming the implantable medical device; and

monitoring the communications link between the implantable medical device and the remote medical communications system.

8. The method of claim 1, wherein step (e) includes collecting a set of ECG and telemetry waveform data as a data set and transmitting the data set to the remote medical communications system.

9. The method of claim 8, wherein collecting telemetry waveform data includes sampling data to validate integrity of a telemetry communications link.

10. The method of claim 9, further comprising the step of transmitting a telemetry communications link status code to the application program and to the extender module.

11. The method of claim 1, further comprising the step of disabling the application proxy and terminating the communications link when an interruption of communications with the implantable medical device is not detected after step (e).

12. A system for conducting failure mode recovery in an implantable medical device upon interruption of with the implanted medical device, the system comprising:

(a) a remote medical communications system having an implantable medical device programming application program;

(b) a programming extender module interfacing the medical communications system to the implantable medical device and being, configured to receive an application proxy from the application program;

(c) means for establishing a communications link between the medical communications system and the programming extender module;

(d) means for loading an application proxy into the;

programming extender module and transitioning the implantable medical device to a known recovery state in response to an interruption in communications between the medical communications system and the implantable medical device;

(e) means for transitioning the implantable medical device to a predetermined completed state;

(f) means for monitoring transition of the implantable medical device to the completed state; and

(g) the application proxy being configured to automatically restore the implantable medical device to the recovery state when an interruption in communications between the medical communications system and the implantable medical device is detected while the implantable medical device is transitioning to the completed state.

13. A method for collecting waveform data from a patient'"'"'s heart, the method comprising:

(a) establishing a communications link between a remote medical communications system having an application program and an extender module configured to receive an application proxy from the application program;

(b) loading the application proxy into the extender module via the application program, the extender module being proximate the patient'"'"'s heart, the application proxy being configured to execute the application program and to re-establish the communications link in response to a loss of communications;

(c) collecting waveform data from the patient'"'"'s heart; and

(d) monitoring the communications link between the remote medical communications system and the extender module for a loss of communications and advising the application proxy if a loss of communications is detected.

14. A system for collecting waveform data from a patient'"'"'s heart, the system comprising:

(a) a remote medical communications system having an implantable medical device programming application program;

(b) a programming extender module interfacing the medical communications system to the implantable medical device and being configured to receive an application proxy from the application program, the programming extender module being located proximate the patient'"'"'s heart;

(c) means for establishing a communications link between the medical communications system and the programming extender module;

(d) means for loading the application proxy into the programming extender module to re-establish an interrupted communications link;

(e) means for collecting waveform data from the patient'"'"'s heart; and

(f) means for monitoring the communications link between the medical communications system and the programming extender module and advising the application proxy if an interruption of the communications link is detected.

15. A method for conducting failure mode recovery in an implantable medical device upon loss of communications with a remote medical communications system, the method comprising:

(a) loading an application proxy from a programming application program resident on the remote medical communications system into a programming extender module, the application proxy being configured to transition the implantable medical device to a known recovery state in response to a loss of communications;

(b) establishing a communications link between the implantable medical device and the remote medical communications system via the programming extender module;

(c) transitioning the implantable medical device to a completed state via the programming application program;

(d) monitoring transition of the implantable medical device to the completed state; and

(e) automatically restoring the implantable medical device to the known recovery state by the application proxy if a loss of communications is detected while transitioning the implantable medical device to the completed state.

16. The method of claim 15, wherein the restoring step includes the steps of implementing downlink transmission commands;

monitoring the communications link for changes in status; and

reporting changes in the communications link status via a user interface.

17. The method of claim 16, wherein the restoring step further includes the steps of mapping events to downlink transmissions and coordinating implantable medical device interactions with the application program.

18. The method of claim 15, wherein the monitoring step includes the step of monitoring the communications link between the implantable medical device and the remote medical communications system.

19. A system for conducting failure mode recovery in an implantable medical device upon loss of communications with a remote medical communications system having an application program for programming the implantable medical device, the system comprising:

(a) a programming extender module interfacing the implantable medical device with the remote medical communications system;

(b) means for loading an application proxy from the application program into the programming extender module, the application proxy configured to transition the implanted device to a known recovery state in response to a loss of communications;

(c) means for establishing a communications link between the implantable medical device and the medical communications system via the extender module after a loss of communications;

(d) means for transitioning the implantable medical device to a completed state via the application program;

(e) means for monitoring transition of the implantable medical device to the completed state; and

(f) means for automatically restoring the implantable medical device to the known recovery state if a loss of communications is detected while the implantable medical device is transitioning to the completed state.

20. A method for conducting failure mode recovery in an implantable medical device upon loss of communications with a remote medical communications system, the method comprising:

(a) establishing a first communications link between the remote medical communications system and an extender module;

(b) loading an application proxy from a programming application program resident on the remote medical communications system into the extender module, the application proxy being configured to transition the implantable medical device to a known recovery state in response to a loss of communications;

(c) establishing a second communications link between the implantable medical device and the remote medical communications system via the extender module;

(d) transitioning the implantable medical device to a completed state via the application program;

(e) monitoring transition of the implantable medical device to the completed state; and

(f) automatically restoring the implantable medical device to the known recovery state by the application proxy if a loss of communications is detected while transitioning the implantable medical device to the completed state.

21. The method of claim 20, wherein the restoring step includes the steps of implementing downlink transmission commands;

monitoring the communications link for changes in status; and

reporting changes in the communications link status via a user interface.

22. The method of claim 20, wherein the restoring step further includes the steps of mapping events to downlink transmissions and coordinating implantable medical device interactions with the application program.

23. The method of claim 20, wherein the monitoring step includes the step of monitoring the communications link between the implantable medical device and the remote medical communications system.

24. A system for conducting failure mode recovery in an implantable medical device upon loss of communications with a remote medical communications system, the system comprising:

(a) a programming extender module;

(b) means for establishing a first communications link between the remote medical communications system and the programming extender module;

(c) means for loading a application proxy from a programming application program resident on the remote medical communications system into the programming extender module, the application proxy being configured to transition the implantable medical device to a known recovery state in response to a loss of communications;

(d) means for establishing a second communications link between the implantable medical device and the remote medical communications system via the programming extender module;

(e) means for transitioning the implantable medical device to a completed state via the application program;

(f) means for monitoring transition of the implantable medical device to the completed state; and

(g) an application proxy configured to automatically restore the implantable medical device to the known recovery state if a loss of communications is detected while transitioning the implantable medical device to the completed state.