Implantable Pacemaker Cardiac Remodeling Detection

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Solution Overview

Problem

Current methods for monitoring cardiac remodeling in patients with implantable medical devices are limited by the need for costly and invasive echocardiogram examinations, which provide late diagnosis, and existing automatic analysis techniques are sensitive to lead position and unstable parameters, leading to delayed detection of adverse changes.

Innovation Solution

An implantable pacemaker device with means for controlled stimulation and morphological analysis of endocardial electrogram signals, combining bipolar and unipolar signals to create a 2D vectogram characteristic, allowing for long-term monitoring of cardiac remodeling and immediate alerts for potential ischemia or lead displacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If echocardiogram examinations are used to monitor cardiac remodeling, then diagnostic accuracy is improved, but device complexity and cost increase, and detection timing is delayed

Engineering Contradiction:

Improvediagnostic accuracyVSAvoiddevice complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical echocardiogram examination system with an electrical signal-based monitoring system using endocardial electrograms. The device uses electrical field measurements (bipolar and unipolar signals) to detect cardiac remodeling through morphological analysis of depolarization waves, substituting mechanical ultrasound imaging with electrical signal processing to achieve continuous monitoring without external equipment.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The implantable device performs self-monitoring by continuously analyzing its own recorded endocardial electrogram signals. The morphological analysis algorithm automatically detects changes in depolarization waveforms and identifies remodeling patterns without requiring external physician intervention or echocardiogram examinations, enabling the system to serve itself for diagnostic purposes.

Inventive Principle:

Principle #25Self-service

2Productivity

If existing automatic analysis techniques are used, then monitoring frequency is improved, but measurement stability deteriorates due to sensitivity to lead position

Engineering Contradiction:

Improvemonitoring frequencyVSAvoidmeasurement stability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent transitions from analyzing single-dimensional unipolar signals to using two-dimensional bipolar signal differences between adjacent electrodes. By calculating the difference between bipolar signals from sequential electrodes, the system creates a new dimensional perspective that eliminates lead position sensitivity while preserving remodeling detection capability, allowing continuous monitoring without compromising measurement stability.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The analysis focuses on local electrical activity differences between adjacent electrodes rather than global unipolar signals. The bipolar derivative captures localized depolarization wavefront characteristics that are insensitive to overall lead position, enabling stable measurements that reflect true local cardiac electrical properties and remodeling changes.

Inventive Principle:

Principle #3Local quality

3Loss of time

If continuous monitoring is implemented, then detection timing is improved, but energy consumption increases

Engineering Contradiction:

Improvedetection timingVSAvoidenergy consumption

Core Design Contradiction:

Loss of timeVSUse of energy by moving object

Solution Approach 1:

The device implements periodic morphological analysis at predetermined time intervals rather than continuous processing. The system records endocardial electrograms continuously but performs computational analysis periodically, comparing current depolarization waveforms with historical reference data at scheduled intervals. This approach enables timely detection of remodeling while allowing energy-saving modes between analysis cycles.

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS10420945B2Active implantable medical device for detecting a remodeling or reverse remodeling phenomenon of the patient

Publication Date: 2019.09.24 SORIN CRM

AI summary

According to some embodiments, a device operates by comparative morphological analysis of depolarization signals collected in spontaneous rhythm on separate respective channels, with two temporal components combined into a single 2D parametric VGM vectogram characteristic. Similarity quantification methods evaluate a variation over time of a descriptor parameter of a current VGM compared to a stored previous reference VGM. This variation is compared with predetermined thresholds to diagnose an occurrence of remodeling or reverse remodeling in a patient, and/or to detect a lead failure or an occurrence of ischemia. The descriptor parameter is a function of a velocity vector of the VGM, a comparison relating to a correlation coefficient between respective magnitudes of a current VGM velocity vector and of a reference VGM velocity vector, and an average angle between these respective velocity vectors.