Detection of implantable lead failures by differential EGM analysis

• US 10,195,420 B2
• Filed: 11/07/2016
• Issued: 02/05/2019
• Est. Priority Date: 06/13/2013
• Status: Active Grant

• Current Assignee: Lambda Nu Technology LLC
• Original Assignee: Lambda Nu Technology LLC
• Inventors: Swerdlow, Charles D.
• Primary Examiner(s): Voorhees, Catherine
• Application Number:
  US15/344,864
• Publication Number:
  US 20170120045A1
• Time in Patent Office: 820 Days
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/3937 Monitoring output parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A method and system for the diagnosis of anomalies in a lead attached to an implantable medical device, such as an implantable cardioverter defibrillator (ICD), including an insulation breach resulting in a short circuit of the high-voltage shock pulse. Determination that the defibrillation pathway is shorted may be made by initial analysis of a Reference EGM and Diagnostic EGM and subsequent analysis of Differential Diagnostic EGMs. Upon determining if a specific defibrillation pathway is shorted, the nonessential defibrillation electrode of that pathway may be excluded from the defibrillation circuit, delivering defibrillation current only between functioning defibrillation electrodes. Alternatively, the ICD system can confirm the presence of a lead anomaly with one or more alternative diagnostic approaches. Patient and remote-monitoring alerts may be initiated.

Claims

1. An automated method of diagnosing an anomaly in an implantable lead of an implantable cardioverter defibrillator (ICD) attached to a single-coil defibrillation lead that includes conductors connected to a first low-voltage electrode and a second low-voltage electrode and a high-voltage coil electrode, comprising:

monitoring electrogram (EGM) signals from a Reference EGM defined by a pathway between the first and the second low-voltage electrodes through the conductors in the implantable lead and a Diagnostic EGM defined by a pathway between the high-voltage coil electrode and the first low-voltage electrode through conductors in the implantable lead;

automatically determining valid ventricular events in the Reference EGM;

automatically comparing the Diagnostic EGM with the Reference EGM to determine if noncardiac signals other than valid ventricular events are present on the Diagnostic EGM; and

in response to the presence of noncardiac signals other than valid ventricular events on the Diagnostic EGM, automatically initiating one or more responses selected from the group consisting of;

initiating one or more additional diagnostic tests to confirm that the electrode responsible for the noncardiac signals shorts the defibrillation pathway,

initiating a patient alert, and

initiating a remote-monitoring alert.

2. The method of claim 1 wherein the Diagnostic EGM is an integrated-bipolar EGM, the first low-voltage electrode is a right ventricular (RV) Tip electrode, and the high-voltage coil is an RV Coil.

3. The method of claim 1 wherein:

the lead is a true-bipolar lead, the first low-voltage electrode is a tip electrode, and the second low-voltage electrode is a ring electrode;

or

the lead is an integrated-bipolar lead, the first low-voltage electrode is a tip electrode, and the second low-voltage electrode is a can electrode.

4. The method of claim 1 wherein at least one of the one or more responses comprises initiating one or more additional diagnostic tests to confirm that the electrode responsible for the noncardiac signals shorts the defibrillation pathway and at least one of the one or more additional diagnostic tests includes delivery of one or more high-voltage, short-duration, sliver pulses.

5. The method of claim 1, wherein the signals from the Reference EGM and the Diagnostic EGM are monitored continuously.

6. The method of claim 1, wherein the signals from the Diagnostic EGM are not monitored continuously.