Apparatus for detecting and localizing insulation failures of implantable device leads

• US 9,821,156 B2
• Filed: 02/26/2016
• Issued: 11/21/2017
• Est. Priority Date: 06/01/2012
• Status: Active Grant

• Current Assignee: Lambda Nu Technology LLC
• Original Assignee: Lambda Nu Technology LLC
• Inventors: Kroll, Mark W., Swerdlow, Charles D.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/054,538
• Publication Number:
  US 20160250462A1
• Time in Patent Office: 634 Days
• Field of Search: 607 5, 607 63, 607115
• 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. An apparatus for detecting insulation failures of an implantable defibrillation lead in electrical communication with the heart of a patient, the apparatus comprising:

an AC signal generator operably coupleable to the implantable defibrillation lead and configured to output a generated signal having a voltage that is below a pacing threshold and having a frequency that is higher than a cardiac cell capture frequency above which cardiac cell capture occurs in response to stimulation;

an AC amplifier having one input connected to a plurality of recording sites and one input connected to a reference electrode, the AC amplifier amplifying skin surface signals from a plurality of recording sites on a surface of the skin of the patient, the recording sites being located at one or more external locations in the region of the defibrillation lead within the body of the patient;

a filter connected to the amplifier output and to the output of the AC signal generator, the filter configured to produce a filtered signal passing signal characteristics of the generated signal; and

circuitry operably coupleable to the filter to receive the filtered signal and configured to generate a human or machine readable representation of an electrical potential of the filtered signal at each one of the plurality of recording sites, the human or machine readable representation indicating presence of an insulation failure based at least in part on an analysis of a local maximum voltage spike.

2. The apparatus of claim 1, wherein the circuitry operably coupleable to the filter comprises a modulator configured to output a modulated representation of the filtered signal, the modulated representation of the filter signal being configured for processing by an electrocardiogram (ECG) device.

3. The apparatus of claim 2, wherein the modulated representation of the filtered signal is a lower frequency representation of the filtered signal.

4. The apparatus of claim 3, wherein the modulated representation of the filtered signal has a frequency of 100 Hz.

5. The apparatus of claim 1, wherein the circuitry operably coupleable to the filter comprises a digital meter configured to display the filtered signal.