Sternal Midline ECG Patch for Low Amplitude P-Wave Detection

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Solution Overview

Problem

Current ambulatory electrocardiography monitoring systems are inadequate for capturing low amplitude cardiac action potential propagation, particularly atrial activation P-waves, due to their design and placement, which leads to poor signal fidelity and discomfort for extended wear, limiting their effectiveness in diagnosing cardiac rhythm disorders.

Innovation Solution

An ambulatory electrocardiography monitor with a flexible extended wear electrode patch positioned along the sternal midline, combined with a reusable monitor recorder, optimized to sense low amplitude cardiac action potentials by minimizing tissue and body structure interference, and designed for comfort and ease of use, allowing extended wear without constant electrode repositioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional ECG monitoring systems are used, then basic cardiac electrical activity can be recorded, but low amplitude atrial P-waves cannot be captured with sufficient fidelity

Engineering Contradiction:
Improvesignal fidelityVSAvoidcapture of low amplitude signals
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent positions electrodes specifically along the sternal midline (precordium) to optimize detection of atrial electrical activity. This localized electrode placement creates optimal sensing vectors that are specifically tuned to capture low amplitude P-waves, rather than using generic ECG electrode positions. The monitoring patch is designed to conform to the sternal contour, ensuring consistent local contact quality for enhanced signal detection.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent employs high-input impedance amplifiers and optimized filtering parameters to enhance detection of low amplitude signals. The system adjusts gain and filtering parameters specifically to preserve low frequency, low amplitude atrial activity while rejecting noise. This parameter optimization enables reliable capture of P-waves that would otherwise be lost in conventional monitoring systems.

Inventive Principle:
Principle #35Parameter changes

2Duration of action of moving object

If extended wear monitoring is implemented, then more comprehensive cardiac data can be collected, but patient comfort and electrode stability deteriorate

Engineering Contradiction:
Improvemonitoring durationVSAvoidpatient comfort
Core Design Contradiction:
Duration of action of moving objectVSEase of operation

Solution Approach 1:

The patent utilizes a flexible, thin monitoring patch that conforms to the sternal contour. This flexible substrate allows the device to move with the patient's body without causing discomfort or skin irritation. The patch maintains stable electrode contact over extended periods while accommodating normal physiological movements, enabling comfortable wear for 7 days or longer.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The monitoring system is designed to be dynamically adaptable to patient movement and physiological changes. The flexible electrode array maintains optimal contact pressure and positioning despite body motion, breathing, and daily activities. This dynamic adaptability ensures continuous stable signal acquisition without requiring electrode repositioning or causing patient discomfort during extended wear periods.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If standard ECG electrode placement is used, then general cardiac monitoring is achieved, but atrial P-wave detection is insufficient

Engineering Contradiction:
ImproveP-wave detectionVSAvoidelectrode placement requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the monitoring function into discrete electrode elements arranged along the sternal midline. This segmented electrode array provides multiple sensing points that can be optimally positioned to detect atrial electrical activity. The segmentation allows the system to capture P-waves from multiple locations, improving detection reliability without requiring complex manual placement procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The flexible patch design with pre-positioned electrodes along the sternal midline enables self-application by patients or caregivers without requiring specialized training. The electrodes are already optimally positioned for P-wave detection, eliminating the need for complex placement procedures. The patch automatically conforms to the sternal contour, ensuring proper electrode positioning and orientation for enhanced atrial signal detection.

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution significantly improves the capture of low amplitude cardiac signals, enhances patient comfort, and enables extended monitoring periods, potentially exceeding conventional limits, facilitating more accurate diagnosis of cardiac rhythm disorders and other physiological events.

Implementation Method 1

an ECG measures the electrical signals emitted by the heart as generated by the propagation of the action potentials that trigger depolarization of heart fibers

Methodology Applied
Scientific EffectElectrical signal detection: Electric Field

Implementation Method 2

The ECG electrodes are provided within a moisture-resistant seal and are electrically coupled to a flexible circuit

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP3193705B1Ambulatory electrocardiography monitoring patch
Publication Date: 2019.04.10 BARDY DIAGNOSTICS INC
  • EP3193705B1 patent drawingFigure 1~2
  • EP3193705B1 patent drawingFigure 3
  • EP3193705B1 patent drawingFigure 4~5

AI summary

Physiological monitoring is provided through a lightweight wearable monitor (12) that includes a flexible extended wear electrode patch (15) and a reusable monitor recorder (14) that removably snaps into a receptacle (25) on the electrode patch (15). The wearable monitor (12) sits centrally along a patient's sternum (13) oriented top-to-bottom. Placement of the wearable monitor (12) at the sternal midline (16), with its unique narrow "hourglass"-like shape, significantly improves the ability of the wearable monitor (12) to cutaneously sense cardiac electrical potential signals, particularly P-wave and QRS interval signals indicating ventricular activity in ECG waveforms. ECG electrodes (38, 39) on the electrode patch (15) are tailored to be positioned axially along the midline (16) of the sternum (13) for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG used to sense positive or upright P-waves (121).