Method and apparatus for detection of lead conductor anomalies using dynamic electrical parameters

• US 9,827,416 B2
• Filed: 08/28/2014
• Issued: 11/28/2017
• Est. Priority Date: 08/25/2009
• Status: Active Grant

• Current Assignee: Lambda Nu Technology LLC
• Original Assignee: Lambda Nu Technology LLC
• Inventors: Swerdlow, Charles
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/472,027
• Publication Number:
  US 20150088213A1
• Time in Patent Office: 1,188 Days
• Field of Search: 607 27- 29, 607 5, 607 63
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

A method and apparatus to detect anomalies in the conductors of leads attached to implantable medical devices based on the dynamical electrical changes these anomalies cause. In one embodiment, impedance is measured for weak input signals of different applied frequencies, and a conductor anomaly is detected based on differences in impedance measured at different frequencies. In another embodiment, a transient input signal is applied to the conductor, and an anomaly is identified based on parameters related to the time course of the voltage or current response, which is altered by anomaly-related changes in capacitance and inductance, even if resistance is unchanged. The method may be implemented in the implantable medical device or in a programmer used for testing leads.

Claims

1. A method for determination of anomalies in an implanted lead within a patient, the method comprising the steps of:

a. delivering one or more signals at a subset of frequencies to one or more conductors in the implanted lead,

b. measuring two or more parameters determined by the inductance or capacitance of the one or more conductors in response to a transmitted signal, the two or more measured parameters selected from the group consisting of;

complex impedance including real and imaginary components, admittance, susceptance, resonance frequency, and phase angle,

c. determining at least one relationship between the two or more measured parameters,

d. comparing the at least one relationship to a predetermined expected range of relationships, and

e. detecting an anomaly based on a change between the determined and expected relationships,

wherein the anomaly can be any of a partial conductor fracture or a complete conductor fracture, or a partial insulation failure or a complete insulation failure.

2. The method of claim 1 in which the lead is attached to a pulse generator in an implantable cardioverter defibrillator (ICD) or a pacemaker, and wherein the lead is implanted intracardiac, intravascularly, or subcutaneously.

3. The method of claim 1, further comprising the step of responding to the detection of the anomaly.

4. The method of claim 3 in which the response is notification of a patient or a physician via an alert mechanisim.

5. The method of claim 3 in which the response is an indication change one or more of the pulse generator'"'"'s programmed settings.

6. The method of claim 1 in which one of the measured parameter is measured from a reflected signal.

7. The method of claim 1 in which the measured parameter is related to current induced in one conductor by a test signal in a different conductor.

8. The method of claim 1 in which the step of measuring is made in a domain selected from the group consisting of:

a time-domain and a transformed domain.

9. The method of claim 1 in which the at least one relationship is a mathematical relationship.

10. The method of claim 1 in which:

a. one or more derived numerical results are calculated for each comparison, and

b. the presence of an anomaly is detected by comparison of the values of the derived numerical results to a range of expected values.

11. The method of claim 1 in which one of the measured parameters includes a time for the voltage or current response to the impulse to decline to a predetermined fraction of an initial value.

12. The method of claim 1 in which one of the measured parameters includes an interval between baseline crossings of the voltage or current response to the signal or a number of baseline crossings in a predetermined period of time.

13. The method of claim 1 wherein the one or more signals is delivered as

a test signal that has a known duration.

14. The method of claim 13 in which one of the measured parameters includes a time course of the voltage or current response to the signal during the pulse duration.

15. The method of claim 14 in which one of the measured parameters is a ratio of the voltage or current response at a predetermined fraction of the pulse duration to its value at the end of the pulse.

16. The method of claim 13 in which the test signal is a pacing pulse.

17. The method of claim 1 in which the signals are delivered at intervals on an automated, periodic basis.

18. The method of claim 17 in which the intervals are determined by values of at least one of the measured parameters or the variability of these values.

19. The method of claim 1 in which:

a. a variability of the measured parameters are determined, and

b. the anomaly is detected if the variability exceeds a predetermined value.

20. The method of claim 1 in which the measured parameters are a real impedance and an imaginary impedance.