Unipolar Electrogram Negative Component Monitoring

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Solution Overview

Problem

During cardiac electrophysiology procedures, physicians face challenges in detecting cardiac events like tachycardia due to overwhelming data and distinguishing between life-threatening and non-life-threatening events based on unique patient characteristics, and there is a need to determine the endpoint for radiofrequency energy application during pulmonary vein isolation to ensure effective transmural lesion creation.

Innovation Solution

A system and method for monitoring cycle length and pattern changes in cardiac signal data using templates to alert physicians through color changes on a display when parameters deviate from predefined thresholds, and monitoring the negative component of unipolar electrograms to determine when to stop radiofrequency energy application, indicating the formation of a transmural lesion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If continuous monitoring of unipolar electrogram is performed to detect transmural lesion, then diagnostic accuracy is improved, but data complexity and difficulty of detection increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddifficulty of detection
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The patent extracts and isolates the negative component from the unipolar electrogram signal for separate analysis. By taking out this specific feature, the system simplifies the detection task while maintaining diagnostic accuracy, as the negative component is the key indicator of transmural lesion without requiring analysis of the entire complex signal waveform.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent segments the electrogram signal into distinct components, specifically isolating the negative component from the overall waveform. This segmentation allows for targeted monitoring of the critical feature that indicates transmural lesion, reducing the complexity of detection while improving measurement precision.

Inventive Principle:
Principle #1Segmentation

2Speed

If real-time monitoring of cardiac events is implemented, then responsiveness is improved, but device complexity and data processing requirements increase

Engineering Contradiction:
ImproveresponsivenessVSAvoiddevice complexity
Core Design Contradiction:
SpeedVSDevice complexity

Solution Approach 1:

The system extracts and monitors only the negative component of the electrogram rather than processing the entire complex signal. This extraction approach enables real-time monitoring and rapid detection of transmural lesion while reducing the computational burden and device complexity required for data processing.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent focuses monitoring on a specific parameter change (the presence or absence of the negative component) rather than analyzing multiple signal characteristics. This parameter-focused approach achieves real-time responsiveness while simplifying the device requirements, as it only needs to detect changes in this single critical parameter.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If threshold-based alerting is used to identify cardiac events, then ease of operation is improved, but measurement precision may be compromised

Engineering Contradiction:
Improveease of operationVSAvoidmeasurement precision
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent establishes a clear threshold parameter for the negative component detection (presence vs. absence). This binary threshold approach simplifies operation for the user while maintaining high measurement precision, as the threshold is based on the definitive characteristic of transmural lesion rather than subjective interpretation of complex waveforms.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20240245340A1Elimination of negative component of unipolar atrial electrogram and signaling of same
Publication Date: 2024.07.25 BIOSIG TECHNOLOGIES INC
  • US20240245340A1 patent drawing
  • US20240245340A1 patent drawing
  • US20240245340A1 patent drawing

AI summary

Disclosed herein are system and method aspects for monitoring changes in a negative component of a unipolar electrogram. The system can include a memory and at least one processor coupled to the memory. The at least one processor can be configured to receive a unipolar electrogram signal from a catheter, display on at least one digital display a signal waveform based on the unipolar electrogram signal using a first attribute. The signal waveform can represent one or more cycles from a patient's heart. The at least one processor can also be configured to monitor the signal waveform to detect a change in a negative component of the unipolar electrogram signal and to signal the change on the at least one digital display when the change is detected in at least a threshold number of consecutive cycles.