Method for detecting and localizing insulation failures of implantable device leads

• US 9,272,150 B2
• Filed: 03/15/2013
• Issued: 03/01/2016
• Est. Priority Date: 06/01/2012
• Status: Active Grant

• Current Assignee: Lambda Nu Technology LLC
• Original Assignee: Lambda Nu Technology LLC
• Inventors: Kroll, Mark William, Swerdlow, Charles Dennis
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US13/833,477
• Publication Number:
  US 20130325079A1
• Time in Patent Office: 1,082 Days
• Field of Search: 607/5, 607/63, 607/115
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

The invention relates to a method and apparatus for diagnosis of conductor anomalies, such as insulation failures, in an implantable medical device, such as an implantable cardioverter defibrillator (ICD), a pacemaker, or a neurostimulator. Insulation failures are detected and localized by identifying changes in electrical fields via surface (skin) potentials. Small variations in potential are detected along the course of the electrode near the site of insulation failure.

Claims

1. A method for detecting an insulation failure of an implantable defibrillation lead, the defibrillation lead connected to an implanted electromedical device and in electrical communication with a heart of a patient comprising:

delivering at least one low amplitude test electrical pulse that is below a pacing threshold having a pacing rate faster than a spontaneous ventricular rate through at least one conductor in the defibrillation lead;

recording an electrical potential at recording sites, said recording sites being located at one or more body locations spaced apart from and relative to a path of the defibrillation lead;

wherein recording said electrical potential is accomplished via a single roving electrode placed sequentially at different exterior body surface locations; and

analyzing said electrical potential recorded from said recording sites to determine a presence of an insulation failure by recognizing a local maximum voltage spike in said electrical potential recorded from said recording sites wherein a local maximum voltage spike is recognized when said electrical potential at one of more of said recording sites is significantly higher than an electrical potential at other recording sites.

2. The method of claim 1 wherein the delivering of at least one test electrical pulse is from the implanted electromedical device.

3. The method of claim 1 wherein the delivering of at least one test electrical pulse is from an external test device.

4. The method of claim 1 wherein the implanted electromedical device is selected from the group consisting of implantable cardioverter defibrillators with transvenous leads, implantable cardioverter defibrillators with subcutaneous leads, vagal nerve stimulators, pain stimulators, pacemakers, and neurostimulators.

5. The method of claim 1 wherein the delivering of at least one test electrical pulse further comprises delivering a plurality of low amplitude test electrical pulses, wherein each of the plurality of low amplitude test electrical pulses are delivered at different voltages.

6. The method of claim 1 wherein a relative change in electrical potentials at different recording sites identifies the presence of the insulation failure.

7. The method of claim 1 wherein the implanted electromedical device is an implantable cardioverter defibrillator and the lead is a multilumen defibrillation lead.

8. The method of claim 7 wherein the at least one test electrical pulse is delivered through at least one pair of conductors, the pair of conductors selected from the group consisting of pace to sense, ring to right-ventricular coil, tip to right-ventricular coil, and right-ventricular coil to superior vena cava coil.

9. The method of claim 1 wherein the at least one test electrical pulse is delivered through a multiplicity of pairs of conductors and the insulation failure is identified by differences in the pattern of recorded electrical potentials.

10. The method of claim 1 wherein the at least one test electrical pulse is delivered through an implanted pulse generator and measurements from cutaneous electrodes are analyzed in near real time using an external test device.

11. The method of claim 1 further comprising:

delivering the at least one test electrical pulse through an implanted pulse generator;

storing measurements from cutaneous electrodes in an ambulatory recording device or long-term electrocardiographic event recorder; and

downloading the stored measurements to an external analysis unit after a monitoring period.

12. The method of claim 11 further comprising activating data storage in the ambulatory recording device via telemetry from the implanted pulse generator.

13. The method of claim 1 further comprising:

recording a distribution of body surface potentials in response to a plurality of test pulses delivered via various combinations of conductors after implant;

storing the distribution of body surface potentials as a baseline map;

recording a subsequent distribution of body surface potentials;

comparing the subsequent distribution of body surface potentials with the baseline map; and

identifying an insulation failure relative to the subsequent distribution of body surface potentials differing sufficiently from the baseline map.

14. The method of claim 1, further comprising localizing the insulation failure by:

modifying a high resolution inverse-ECG system to provide potentials along a path of the implantable lead;

attaching the inverse-ECG system to the patient;

delivering pacing or impedance test stimuli;

locating maximum signals not at an electrode; and

localizing the insulation break to a region of maximum signal not adjacent to an electrode.

15. A method for detecting an insulation failure of an implantable defibrillation lead, the defibrillation lead connected to an implanted electromedical device and in electrical communication with a heart of a patient comprising:

delivering at least one low amplitude test electrical pulse that is below a pacing threshold having a pacing rate faster than a spontaneous ventricular rate through at least one conductor in the defibrillation lead;

recording an electrical potential at recording sites, said recording sites being located at one or more body locations spaced apart from and relative to the path of the defibrillation lead; and

analyzing said electrical potential recorded from said recording sites to determine a presence of an insulation failure by recognizing a local maximum voltage spike in said electrical potential recorded from said recording sites wherein a local maximum voltage spike is recognized when said electrical potential at one of more of said recording sites is significantly higher than an electrical potential at other recording sites;

wherein recording the electrical potential is accomplished via one or more electrodes located within the body, the electrodes not being connected to the implantable lead being analyzed for said insulation failure; and

wherein the electrodes include;

an implantable cardioverter defibrillator housing; and

an electrode temporarily implanted within the surgical pocket.