Ambulatory ECG Patch Sternal Midline Placement for P-Wave Capture

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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 results in poor signal fidelity and comfort issues for extended wear, especially in individuals with breast anatomy or skin conditions.

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 signals by minimizing tissue and body structure interference, and designed for easy placement and replacement to accommodate patient comfort and long-term monitoring.

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 P-waves and atrial activation signals cannot be captured with sufficient fidelity

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

Solution Approach 1:

The patent applies local quality by positioning electrodes at specific anatomical locations (sternal midline, infraclavicular fossa, axilla) where the electrical signals from atrial activation are locally amplified and less attenuated by intervening tissues. This localized electrode placement optimizes the detection of low amplitude P-waves and atrial signals at these specific body sites.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent introduces a new spatial dimension for ECG recording by placing electrodes along the sternal midline and using body positions (supine, sitting, standing) as additional recording dimensions. This multi-dimensional approach captures cardiac electrical activity from perspectives not available in conventional horizontal lead placements, improving detection of atrial activation vectors.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Duration of action of moving object

If extended wear monitoring is implemented, then continuous ECG data can be collected, but patient comfort and skin condition issues arise

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

Solution Approach 1:

The patent segments the monitoring system into a reusable controller unit and disposable electrode patch assemblies. The disposable patches can be easily applied and removed without affecting the main electronics, allowing patients to undergo multiple monitoring periods with minimal discomfort and skin irritation from repeated adhesive application.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs disposable electrode patches that are discarded after a single use or short monitoring period. This eliminates the cumulative skin irritation and comfort issues associated with reusing adhesive electrodes, while the low cost of disposable patches makes extended multi-week or multi-month monitoring feasible.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Measurement precision

If electrodes are placed to capture optimal P-wave signals, then signal fidelity improves, but patient comfort and ease of placement deteriorate

Engineering Contradiction:
ImproveP-wave captureVSAvoidplacement difficulty
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent creates a universal electrode patch design that can be placed on multiple body locations (sternum, infraclavicular fossa, axilla) and functions effectively for P-wave detection in various positions. The standardized patch design with pre-positioned electrodes eliminates the need for complex placement procedures while maintaining optimal signal capture across different anatomical sites.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent enables patients to self-apply the electrode patches without requiring medical personnel for placement. The patches are designed with self-adhering characteristics and clear placement guidelines, allowing patients to correctly position them on the sternal midline or other recommended sites independently, thereby improving accessibility and ease of use.

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 action potentials, particularly P-waves, while enhancing patient comfort and allowing for extended wear beyond conventional monitoring periods without the need for continuous electrode placement, thus providing more reliable and continuous ECG data.

Implementation Method 1

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

During each cardiac cycle, the ionic currents create an electrical field in and around the heart that can be detected by ECG electrodes placed on the skin

Methodology Applied
Scientific EffectElectrical conduction through tissue: Conduction (electrical)

Data Source

PatentEP3193703B1Ambulatory electrocardiography monitoring patch
Publication Date: 2020.07.01 BARDY DIAGNOSTICS INC
  • EP3193703B1 patent drawingFigure 1~2
  • EP3193703B1 patent drawingFigure 3
  • EP3193703B1 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 on a patient's chest along the 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 the 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).