Leakage detection within implantable medical system conduction paths

• US 10,220,204 B2
• Filed: 07/31/2017
• Issued: 03/05/2019
• Est. Priority Date: 07/31/2017
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stanslaski, Scott R., Abraham, Timothy R., Denison, Timothy J., Roczniak, Vincent A., Santa, Wesley A., Stroncek, Steven J.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/665,347
• Publication Number:
  US 20190030325A1
• Time in Patent Office: 582 Days
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

Leakage of signal between conduction paths of an implantable medical lead or lead and lead extension combination is detected. A stimulation signal is provided via one electrode. Two other electrodes sense the stimulation signal. A difference in amplitude of the two sensed signals is determined and based on this difference, leakage is detected. A sensing circuit may use differential amplification of the two signals and compare a resulting output signal to a leakage threshold. When the amplitude of the output signal exceeds the leakage threshold, then leakage is occurring between the conduction path providing the stimulation and one of the conduction paths used for sensing. Other techniques for determining leakage from the difference may also be used such as comparing the amplitudes of the two sensed signals and providing a value that is based on the comparison to indicate whether leakage is present.

Claims

1. A method of detecting a signal leakage from a conduction path within an implantable medical lead, comprising:

providing a stimulation signal from a first electrode corresponding to a first conduction path of the implantable medical lead;

sensing the stimulation signal as a first sensed signal via a second electrode corresponding to a second conduction path of the implantable medical device and sensing the stimulation signal as a second sensed signal via a third electrode corresponding to a third conduction path of the implantable medical lead, with the second and third conduction paths being coupled to a sensing circuit of an implantable medical device; and

detecting whether there is leakage between the first and second conduction paths and/or between the first and third conduction paths based on the difference in amplitude of the first and second sensed signals.

2. The method of claim 1, wherein detecting whether there is leakage comprises providing the first and second sensed signals to a differential amplifier that produces a sensed output signal.

3. The method of claim 2, wherein detecting whether there is leakage comprises detecting whether an amplitude of the sensed output signal exceeds a leakage threshold, and when the amplitude exceeds the leakage threshold then providing an indication that there is leakage.

4. The method of claim 3, wherein the leakage threshold is greater than 1 microvolt per root Hertz at an amplitude of the stimulation signal of at least 0.1 milliamps.

5. The method of claim 1, wherein providing the stimulation signal comprises providing the stimulation signal with an amplitude that is below a tissue activation threshold.

6. The method of claim 1, further comprising:

providing a second stimulation signal from the second electrode;

sensing the second stimulation signal as a third sensed signal via the first electrode corresponding to the first conduction path of the implantable medical device and sensing the second stimulation signal as a fourth sensed signal via the third electrode corresponding to the third conduction path of the implantable medical lead, with the first and third conduction paths being coupled to the sensing circuit of an implantable medical device; and

detecting whether there is leakage between the first and second conduction paths and/or between the second and third conduction paths based on the difference in amplitude of the third and fourth sensed signals.

7. The method of claim 1, wherein providing the stimulation signal comprises providing the stimulation signal from a constant current stimulation source.

8. The method of claim 7, wherein providing the stimulation signal comprises providing the stimulation signal with an amplitude less than 0.5 milliamps.

9. The method of claim 1, wherein the implantable medical lead is coupled to an implantable medical device comprising a conductive housing and wherein the conductive housing provides an additional conduction path for the stimulation signal of the first conduction path.

10. The method of claim 1, wherein an implantable lead extension is coupled to the implantable medical lead such that the first, second, and third conduction paths extend through the implantable lead extension.

11. An implantable medical system, comprising:

an implantable medical device having a stimulation engine, having a sensing circuit and having a controller; and

at least one implantable medical lead providing first, second, and third conduction paths, wherein the controller is configured to electrically couple the first conduction path to the stimulation engine to provide a stimulation signal onto the first conduction path, to electrically couple the second and third conduction paths to the sensing circuit where the second conduction path provides a first sensed signal and the third conduction path provides a second sensed signal, and to monitor an output of the sensing circuit to detect whether there is leakage between the first and second conduction paths and/or between the first and third conduction paths based on a difference in amplitude of the first and second sensed signals.

12. The implantable medical system of claim 11, wherein the sensing circuit comprises a differential amplifier and wherein the controller detects whether there is leakage by providing the first and second sensed signals to a differential amplifier that produces a sensed output signal.

13. The implantable medical system of claim 12, wherein the controller detects whether there is leakage by detecting whether the difference exceeds a leakage threshold, and when the amplitude exceeds the leakage threshold then the controller generates an indication that there is leakage.

14. The implantable medical system of claim 13, wherein the leakage threshold is greater than 1 microvolt per root Hertz at an amplitude of the stimulation signal of at least 0.1 milliamps.

15. The implantable medical system of claim 11, wherein the stimulation signal has an amplitude that is below a tissue activation threshold.

16. The implantable medical system of claim 11, wherein the controller is further configured to electrically couple the second conduction path to the stimulation engine to provide a second stimulation signal onto the second conduction path, to electrically couple the first and third conduction paths to the sensing circuit to produce third and fourth sensed signals, and to monitor the output of the sensing circuit to detect whether there is leakage between the first and second conduction paths and/or between the second and third conduction paths based on a difference in amplitude of the third and fourth sensed signals.

17. The implantable medical system of claim 11, wherein the stimulation engine comprises a constant current stimulation source that produces the stimulation signal.

18. The implantable medical system of claim 17, wherein the stimulation signal has an amplitude less than 0.5 milliamps.

19. The implantable medical system of claim 11, wherein the implantable medical device comprises a conductive housing and wherein the conductive housing provides an additional conduction path for the stimulation signal of the first conduction path.

20. The implantable medical system of claim 11, further comprising an implantable lead extension that extends the first, second, and third conduction paths between the implantable medical device and the implantable medical lead.

21. An implantable medical device, comprising:

a stimulation engine;

a sensing circuit;

a first, a second, and a third lead connectors corresponding to first, second, and third conduction paths; and

a controller that is configured to electrically couple the first lead connector to the stimulation engine to provide a stimulation signal onto the first lead connector, to electrically couple the second and third lead connectors to the sensing circuit to produce first and second sensed signals, and to monitor the output of the sensing circuit to detect whether there is leakage between the first and second conduction paths and/or between the first and third conduction paths based on a difference in amplitude of the first and second sensed signals.

22. The implantable medical system of claim 21, wherein the sensing circuit comprises a differential amplifier and wherein the controller detects whether there is leakage by providing the first and second sensed signals to a differential amplifier that produces a sensed output signal.

23. The implantable medical device of claim 22, wherein the controller detects whether there is leakage by detecting whether an amplitude of the sensed signal exceeds a leakage threshold, and when the amplitude exceeds the leakage threshold then the controller generates an indication that there is leakage.

24. The implantable medical device of claim 23, wherein the leakage threshold is greater than 1 microvolt per root Hertz at an amplitude of the stimulation signal of at least 0.1 milliamps.

25. The implantable medical device of claim 21, wherein the stimulation signal has an amplitude that is below a tissue activation threshold.

26. The implantable medical device of claim 21, wherein the controller is further configured to electrically couple the second lead connector to the stimulation engine to provide a second stimulation signal onto the second lead connector, to electrically couple the first and third lead connectors to the sensing circuit to produce third and fourth sensed signals, and to monitor the output of the sensing circuit to detect whether there is leakage between the first and second conduction paths and/or between the second and third conduction paths based on a difference in amplitude of the third and fourth sensed signals.

27. The implantable medical device of claim 21, wherein the stimulation engine comprises a constant current stimulation source that produces the stimulation signal.

28. The implantable medical device of claim 27, wherein the stimulation signal has an amplitude less than 0.5 milliamps.

29. The implantable medical device of claim 21, wherein the implantable medical device comprises a conductive housing and wherein the conductive housing provides an additional conduction path for the stimulation signal of the first lead connector.