Detection of implantable lead failures by differential EGM analysis

• US 9,486,624 B2
• Filed: 03/25/2014
• Issued: 11/08/2016
• 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:
  US14/224,876
• Publication Number:
  US 20140371831A1
• Time in Patent Office: 959 Days
• US Class Current: 1/1
• 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 dual-coil, true-bipolar defibrillation lead that includes sensing conductors connected to tip electrode and a ring electrode and defibrillation conductors connected to a first coil electrode and a second coil electrode, comprising:

monitoring electrogram (EGM) signals from a Reference EGM defined by a pathway between the tip electrode to the ring electrode through the sensing conductors in the implantable lead and a Diagnostic EGM defined by a pathway between the first coil electrode and the second coil electrode through defibrillation 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

when the noncardiac signals other than valid ventricular events are present;

analyzing EGM signals from at least one Differential Diagnostic EGM defined by a pathway between at least one of the first coil electrode and second coil electrode and at least one of the tip electrode and the ring electrode to determine an electrode responsible for the noncardiac signals;

determining if the electrode responsible for the noncardiac signals is a nonessential coil electrode that should be excluded from a defibrillation pathway to prevent shorting during a therapeutic shock; and

when the electrode responsible for the noncardiac signals is a nonessential coil electrode automatically initiating one or more responses selected from the group consisting of;

excluding the nonessential coil electrode from the defibrillation pathway,

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 recorded between the Right Ventricular Coil and Superior Vena Cava Coil (Coil-Coil Diagnostic EGM).

3. The method of claim 1 wherein the at least one Differential Diagnostic EGM is selected from the group consisting of:

the EGM between the tip electrode and Superior Vena Cava Coil (Tip-SVC Coil), the integrated-bipolar EGM, and the EGM between the tip electrode and Right Ventricular Coil (Tip-RV Coil).

4. The method of claim 1 wherein:

the implantable lead is a true-bipolar lead and the Reference EGM is a true-bipolar sensing EGM (Right Ventricular Tip-Right Ventricular Coil EGM); and

the implantable lead is an integrated-bipolar lead and the Reference EGM is a Tip-CAN EGM.

5. The method of claim 1 wherein at least one of the one or more additional diagnostic tests includes delivery of one or more high-voltage, short-duration, sliver pulses.

6. The method of claim 1, wherein the nonessential electrode is the Superior Vena Cava Coil, and therapeutic shocks are delivered between Right Ventricular Coil and CAN.

7. The method of claim 1 wherein the nonessential electrode is the CAN, and therapeutic shocks are delivered between Right Ventricular Coil and Superior Vena Cava Coil.