Identifying lead insulation breaches and externalization of lead conductors

• US 9,956,417 B2
• Filed: 03/14/2013
• Issued: 05/01/2018
• Est. Priority Date: 05/08/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Musley, ShaileshKumar V., Gunderson, Bruce D., Olson, Walter H., Miller, Jennifer P.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US13/803,346
• Publication Number:
  US 20130304139A1
• Time in Patent Office: 1,874 Days
• Field of Search: 607 2, 607 27, 607 29, 607 37, 607 62, 607116
• 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 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

A technique for identifying lead-related conditions, such as insulation breaches and/or externalization of lead conductors, includes analyzing characteristics of electrical signals generated on one or more electrode sensing vectors of the lead by a test signal to determine whether a lead-related condition exists. The characteristics of the electrical signals induced on the lead by the test signal may be significantly different on a lead having an insulation breach or externalized conductor than on a lead not having such lead-related conditions. As such, the implantable medical device may be subject to a known test signal and analyze the signals on the lead to detect lead-related conditions.

Claims

1. An implantable medical system comprising:

at least one implantable medical lead; and

an implantable medical device coupled to the at least one implantable medical lead, wherein the at least one implantable medical lead includes a plurality of electrodes, wherein the implantable medical device includes;

a signal generator configured to generate a test signal and deliver the test signal via a first electrode vector that includes at least one of the plurality of electrodes; and

a processor configured to obtain an electrical signal generated on the lead by delivery of the test signal and analyze the electrical signal to determine whether a lead-related condition exists, wherein the electrical signal is sensed on a second electrode vector that has at least one electrode of the plurality of electrodes different than the first electrode vector.

2. The system of claim 1, wherein the processor is configured to compare a characteristic of the electrical signal sensed on the second electrode vector to an expected characteristic of an expected signal on an intact lead and determine whether a lead-related condition exists based on the comparison.

3. The system of claim 2, wherein the characteristic of the electrical signal sensed on the second electrode vector comprises at least one of an amplitude, a waveform morphology, a frequency, a phase, a slope, or a polarity.

4. The system of claim 1, wherein the processor is configured to compare an amplitude of the electrical signal sensed on the second electrode vector to a threshold amplitude and determine that a lead-related condition exists when the amplitude of the electrical signal sensed on the at least one implantable medical lead is greater than the threshold amplitude.

5. The system of claim 4, wherein the threshold amplitude corresponds with an amplitude of an expected electrical signal generated by the test signal on an intact implantable medical lead that does not have a lead-related condition.

6. The system of claim 1, wherein the implantable medical device includes a housing that functions as a housing electrode, wherein the first electrode vector includes one of the plurality of electrodes of the lead and the housing electrode.

7. The system of claim 1, wherein the implantable medical device is configured to adjust a therapy in response to determining that the lead-related condition exists.

8. The system of claim 7, wherein the implantable medical device is configured to reconfigure which electrodes of the at least one implantable medical lead are used for delivery of the therapy in response to determining that the lead-related condition exists.

9. The system of claim 1, wherein the implantable medical device is configured to provide an alert in response to determining that the lead-related condition exists.

10. The system of claim 1, wherein the signal generator is further configured to generate a plurality of test signals and consecutively deliver subsequent test signals via different pairs of electrodes from the plurality of electrodes.

11. The system of claim 1, wherein the implantable medical lead comprises a plurality of conductors, and the processor is configured to compare an amplitude of the electrical signal sensed on the second electrode vector to a threshold amplitude and determine that at least one of the conductors of the implantable medical lead has externalized when the amplitude of the electrical signal is greater than the threshold amplitude.

12. A method comprising:

delivering, with an implantable medical device, a test signal via a pair of electrodes from a plurality of electrodes implanted within a body of a patient, wherein the test signal is delivered via a first electrode vector that includes at least one of the plurality of electrodes;

sensing, with the implantable medical device, an electrical signal induced on at least one implantable medical lead by the test signal, wherein the electrical signal is sensed on a second electrode vector that has at least one electrode of the plurality of electrodes different than the first electrode vector; and

analyzing, with the implantable medical device, the electrical signal sensed on the second electrode vector to determine whether a lead-related condition exists.

13. The method of claim 12, wherein analyzing the electrical signal sensed on the second electrode vector comprises:

comparing a characteristic of the electrical signal sensed on the second electrode vector to a threshold; and

determining whether the lead-related condition exists based on the comparison.

14. The method of claim 13, wherein

comparing the characteristic of the electrical signal comprises comparing an amplitude of the electrical signal sensed on the second electrode vector to a threshold amplitude;

and

determining whether the lead-related condition exists based on the comparison comprises detecting the lead-related condition exists when the amplitude of the electrical signal sensed on the second electrode vector is greater than the threshold amplitude.

15. The method of claim 14, wherein the threshold amplitude corresponds with an expected amplitude of the electrical signal on an implantable medical lead having no lead-related condition by the test signal.

16. The method of claim 13, wherein:

the implantable medical lead comprises a plurality of conductors;

comparing the characteristic of the electrical signal comprises comparing an amplitude of the electrical signal sensed on the second electrode vector to a threshold amplitude; and

determining whether the lead-related condition exists based on the comparison comprises detecting that at least one of the conductors of the implantable medical lead has externalized when the amplitude of the electrical signal is greater than the threshold amplitude.

17. The method of claim 12, wherein analyzing the electrical signal sensed on the second electrode vector comprises analyzing at least one of an amplitude, a waveform morphology, a frequency, a phase, a slope, or a polarity of the electrical signal sensed on the second electrode vector.