Identifying lead insulation breaches and externalization of lead conductors

• US 9,839,784 B2
• Filed: 03/14/2013
• Issued: 12/12/2017
• Est. Priority Date: 05/08/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gunderson, Bruce D., Olson, Walter H., Musley, ShaileshKumar V., Miller, Jennifer P.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/803,302
• Publication Number:
  US 20130304160A1
• Time in Patent Office: 1,734 Days
• Field of Search: 607 66
• 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. A medical device system comprising:

an external system comprising;

at least two electrodes configured to contact a body of a patient; and

a signal generator electrically coupled to the at least two electrodes, the signal generator configured to generate a first electrical signal to be delivered by the at least two electrodes;

an implantable medical system comprising;

an implantable medical device; and

at least one implantable medical lead coupled to the implantable medical device,

wherein the implantable medical system senses a second electrical signal induced on the at least one implantable medical lead by the first electrical signal generated by the signal generator; and

a processor configured to;

identify a characteristic of the second electrical signal that is indicative of at least one of a breach of outer insulation of a lead body of the at least one implantable medical lead or an externalization of a conductor of the at least one implantable medical lead; and

identify the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on the identification of the characteristic of the second electrical signal.

2. The system of claim 1, wherein the processor is configured to:

identify the characteristic of the second electrical signal by at least comparing the characteristic of the second electrical signal sensed on the at least one implantable medical lead to a threshold; and

identify the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on the comparison.

3. The system of claim 2, wherein the processor is configured to:

identify the characteristic of the second electrical signal by at least comparing an amplitude of the second electrical signal sensed on the at least one implantable medical lead to a threshold amplitude; and

identify the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor when the amplitude of the second electrical signal sensed on the at least one implantable medical lead is greater than the threshold amplitude.

4. The system of claim 3, wherein the threshold amplitude corresponds with an expected amplitude of the second electrical signal induced on the implantable medical lead by the first electrical signal when the implantable medical lead does not have the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

5. The system of claim 1, wherein the characteristic of the second electrical signal sensed on the at least one implantable medical lead comprises at least one of an amplitude, a waveform morphology, a frequency, a phase, a slope, and a polarity.

6. The system of claim 1, wherein the processor resides within the implantable medical device.

7. The system of claim 1, wherein the processor resides within an external device.

8. The system of claim 6, wherein the processor resides within one of a patient monitoring device, a programming device, and a remote server.

9. The system of claim 1, wherein processor is configured to adjust a therapy delivered by the implantable medical device in response to identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

10. The system of claim 1, wherein the processor is configured to provide an alert to in response to identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

11. The system of claim 1, wherein the at least two electrodes comprise patch electrodes that are configured to be placed on the body of the patient.

12. The system of claim 1, wherein the at least two electrodes are configured to contact the body of the patient such that a vector between the at least two electrodes in contact with the body of the patient is not substantially perpendicular to a vector between an externalized conductor of the at least one implantable medical lead and an intact electrode of a sensing electrode pair.

13. The system of claim 1, further comprising:

a control module configured to switch from a first electrode vector used for delivering therapy to a heart of the patient via the at least one implantable lead to a second electrode vector used for delivering therapy to the heart of the patient via the at least one implantable lead in response to the identification of the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

14. The system of claim 1, further comprising:

a control module configured to switch from a first electrode vector used for sensing electrical signals from a heart of the patient via the at least one implantable lead to a second electrode vector sensing electrical signals from the heart of the patient via the at least one implantable lead in response to the identification of the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

15. The system of claim 1, wherein the processor is configured to:

identify the characteristic of the second electrical signal that is indicative of an externalization of the conductor of the at least one implantable medical lead; and

identify the externalization of the conductor based on the identification of the characteristic of the second electrical signal.

16. A method comprising:

providing a first electrical signal generated by an external signal generator to a body of a patient via a pair of electrodes in contact with the body of the patient;

sensing a second electrical signal induced on at least one implantable medical lead by the first electrical signal generated by the signal generator;

identifying a characteristic of the second electrical signal that is indicative of at least one of a breach of outer insulation of a lead body of the at least one implantable medical lead or an externalization of a conductor of the at least one implantable medical lead; and

identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on the identification of the characteristic of the second electrical signal.

17. The method of claim 16, wherein:

identifying the characteristic of the second electrical signal comprises comparing the characteristic of the second electrical signal sensed on the at least one implantable medical lead to a threshold; and

identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor comprises identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on the comparison.

18. The method of claim 17, wherein:

comparing the characteristic of the second electrical signal comprises comparing an amplitude of the second electrical signal sensed on the at least one implantable medical lead to a threshold amplitude; and

identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor comprises identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on whether the amplitude of the second electrical signal sensed on the at least one implantable medical lead is greater than the threshold amplitude.

19. The method of claim 18, wherein the threshold amplitude corresponds with an expected amplitude of the second electrical signal induced on the implantable medical lead by the first electrical signal generated by the signal generator when the implantable medical does not have the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

20. The method of claim 16, further comprising adjusting a therapy provided by the implantable medical system in response to identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor.

21. The method of claim 16, wherein analyzing the second electrical signal comprises analyzing at least one of an amplitude, a waveform morphology, a frequency, a phase, a slope, and a polarity of the second electrical signal.

22. The method of claim 16, further comprising orientating the pair of electrodes to contact the body of the patient such that a vector between the at least two electrodes in contact with the body of the patient is not substantially perpendicular to a vector between an externalized conductor of the at least one implantable medical lead and an intact electrode of a sensing electrode pair.

23. The method of claim 16, wherein:

identifying the characteristic of the second electrical signal comprises identifying the characteristic of the second electrical signal that is indicative of an externalization of the conductor of the at least one implantable medical lead; and

identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor comprises identifying an externalization of the conductor based on the identification of the characteristic of the second electrical signal.

24. A medical device system comprising:

means for generating a first electrical signal to be delivered to a body of a patient via a pair of electrodes in contact with the body of the patient;

means for sensing a second electrical signal induced on at least one implantable medical lead by the first electrical signal;

means for identifying a characteristic of the second electrical signal that is indicative of at least one of a breach of outer insulation of a lead body of the at least one implantable medical lead or an externalization of a conductor of the at least one implantable medical lead; and

means for identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor based on the identification of the characteristic of the second electrical signal.

25. The system of claim 24, wherein:

the means for identifying the characteristic of the second electrical signal comprises means for comparing an amplitude of the second electrical signal sensed on the at least one implantable medical lead to a threshold amplitude; and

the means for identifying at least one of a breach of the outer insulation of the lead body or an externalization of the conductor bases the identification on whether the amplitude of the second electrical signal sensed on the at least one implantable medical lead is greater than the threshold amplitude.

26. The system of claim 24, wherein:

the means for identifying the characteristic of the second electrical signal comprises means for identifying the characteristic of the second electrical signal that is indicative of an externalization of the conductor of the at least one implantable medical lead; and

the means for identifying the at least one of a breach of the outer insulation of the lead body or an externalization of the conductor comprises means for identifying an externalization of the conductor based on the identification of the characteristic of the second electrical signal.