Quad Polar Lead Dislodgement Detection via Electrogram Amplitude Ratios

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current methods for detecting electrical lead dislodgement in implantable medical devices, such as pacemakers and ICDs, are unreliable, particularly for passively-fixated leads in the coronary sinus, as impedance variations can be misleading, and fluoroscopic procedures expose patients to radiation and may not detect micro dislodgement.

Innovation Solution

A quad polar lead with four electrodes in the coronary sinus is used to analyze the relative amplitudes and ratios of atrial and ventricular components of electrograms to determine lead stability, with a programmable microcontroller comparing electrogram templates to test features to assess lead condition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If impedance is used to detect lead dislodgement, then detection capability is provided, but reliability is reduced due to impedance variations over time and lead maturation

Engineering Contradiction:

Improvelead dislodgement detectionVSAvoiddetection reliability

Core Design Contradiction:

Difficulty of detecting and measuringVSReliability

Solution Approach 1:

The patent changes the detection parameter from impedance to electrogram signal characteristics (amplitude, morphology, duration). By measuring electrical signals directly from the heart through the lead electrodes, the system detects lead position changes based on signal variations rather than impedance changes, thereby improving reliability while maintaining detection capability

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces the electrical impedance measurement system with an electrogram signal analysis system. Instead of measuring resistance changes, the system analyzes cardiac electrical signals to detect lead dislodgement, substituting one measurement mechanism with a more reliable electrical signal-based approach

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Difficulty of detecting and measuring

If fluoroscopic procedures are used to detect lead dislodgement, then macro dislodgement detection is achieved, but harmful radiation exposure occurs to patient and physician

Engineering Contradiction:

Improvelead dislodgement detectionVSAvoidradiation exposure

Core Design Contradiction:

Difficulty of detecting and measuringVSObject-affected harmful factors

Solution Approach 1:

The patent replaces fluoroscopic imaging with electrical signal analysis. By using electrogram signals already present in the implantable device, the system eliminates the need for external radiation-based imaging while maintaining lead dislodgement detection capability

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent uses the implantable device's own electrogram sensing capability to detect lead dislodgement, eliminating the need for separate fluoroscopic procedures. The device performs self-diagnosis using its inherent electrical sensing functions

Inventive Principle:

Principle #25Self-service

3Measurement precision

If fluoroscopy is used for lead dislodgement detection, then detection capability is provided, but micro dislodgement remains undetected

Engineering Contradiction:

Improvedislodgement detection precisionVSAvoidmicro dislodgement detection

Core Design Contradiction:

Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The patent changes from imaging-based measurement to electrical signal parameter analysis. By examining electrogram amplitude, morphology, and duration parameters, the system can detect subtle lead position changes that fluoroscopy misses, achieving both macro and micro dislodgement detection

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS9327131B2Detecting implanted medical electrical lead dislodgement using cardiac signals

Publication Date: 2016.05.03 PACESETTER INC

AI summary

Evaluation of an implanted electrical lead condition includes comparing electrogram template features with test electrogram features. The evaluating also includes determining the implanted electrical lead condition based solely on the electrogram comparison. The compared test electrogram features and template electrogram features may be atrial amplitudes and ventricular amplitudes. The sensing may be with a quad polar lead. The compared test electrogram features and electrogram template features may account for different patient postures and/or may account for respiration modulation.