Flexible ECG Patch with Mirror Circuit and Viscoelastic Adhesive

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Solution Overview

Problem

Conventional ECG monitoring systems are cumbersome, costly, and limited in duration, making long-term extended wear impractical for continuous recording of cardiac signals, especially for atrial activity, and often fail to capture sporadic cardiac disorders due to skin irritation, electrode dislodgment, and limited usability.

Innovation Solution

A wearable monitor comprising a flexible extended wear electrode patch and a removable reusable recorder that can be placed anywhere on the sternum for extended periods, interoperable with other sensors and devices for real-time data download, and equipped with wireless communication and strain relief features for comfort and durability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If conventional ECG electrodes are used for long-term monitoring, then continuous recording of cardiac signals is achieved, but skin irritation and electrode dislodgment occur

Engineering Contradiction:
Improvemonitoring durationVSAvoidelectrode adhesion
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The patent changes the physical and chemical parameters of the adhesive layer by incorporating viscoelastic materials with specific loss tangents (0.05-0.5) and using acrylic pressure-sensitive adhesive formulations. These parameter changes enable the adhesive to maintain optimal bonding characteristics over extended periods, resolving the contradiction between long-term monitoring duration and reliable electrode adhesion.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The electrode assembly uses a composite structure combining viscoelastic adhesive layers with acrylic pressure-sensitive adhesives, and flexible circuit boards with strain relief features. This composite material approach allows the system to maintain both long-term adhesion reliability and comfort during extended wear, addressing the contradiction between monitoring duration and electrode stability.

Inventive Principle:
Principle #40Composite materials

2Reliability

If rigid ECG electrodes are fastened firmly to the skin, then signal recording stability is improved, but patient comfort deteriorates and skin irritation increases

Engineering Contradiction:
Improvesignal recording stabilityVSAvoidskin irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs flexible circuit boards with integrated strain relief features and thin viscoelastic adhesive layers that conform to skin contours. These flexible components maintain electrical connection stability while accommodating skin movements and reducing mechanical stress on the skin, thereby resolving the contradiction between signal stability and skin comfort.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The viscoelastic adhesive layer acts as a cushioning element between the rigid electrode components and the skin surface. This beforehand cushioning protects the skin from irritation caused by firm fastening while maintaining adequate adhesion for stable signal recording throughout the monitoring period.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Measurement precision

If ECG electrodes are placed in fixed positions, then diagnostic accuracy is maintained, but patient mobility and daily activities are restricted

Engineering Contradiction:
ImproveECG signal qualityVSAvoidpatient mobility
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent creates a dynamic electrode system where the flexible circuit board and viscoelastic adhesive allow the electrode assembly to move with the patient's body while maintaining skin contact. The strain relief features enable the electrode to accommodate positional changes during daily activities, resolving the contradiction between maintaining ECG signal quality and preserving patient mobility.

Inventive Principle:
Principle #15Dynamics

4Reliability

If adhesive strength is increased to prevent electrode dislodgment, then electrode stability is improved, but skin irritation and patient discomfort increase

Engineering Contradiction:
Improveelectrode stabilityVSAvoidskin irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent optimizes the adhesive parameters by selecting viscoelastic materials with specific loss tangents (0.05-0.5) and acrylic pressure-sensitive adhesive formulations that provide adequate bonding strength without excessive adhesion. This parameter optimization achieves electrode stability while minimizing skin irritation and patient discomfort during extended wear.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The viscoelastic adhesive layer provides beforehand cushioning that distributes mechanical stress away from the skin surface while maintaining sufficient adhesive strength to prevent electrode dislodgment. This cushioning effect resolves the contradiction between electrode stability and skin comfort.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS11445966B2Extended wear electrocardiography and physiological sensor monitor
Publication Date: 2022.09.20 BARDY DIAGNOSTICS INC
  • US11445966B2 patent drawing
  • US11445966B2 patent drawing
  • US11445966B2 patent drawing

AI summary

An extended wear electrocardiography patch is provided. An integrated flexible circuit includes a single piece of material and has an upper end and a lower end opposite the upper end. A mirror image of the upper end extends from at least a portion of one side of the upper end and folds over the upper end. One circuit trace is positioned on the upper end and one circuit trace is positioned on the lower end. Electrical pads are located on a contact surface of the upper end and on an outward facing surface of the mirror image of the upper end. An electrocardiographic electrode is positioned on the contact surface of the upper end and another electrocardiographic electrode is positioned on a contact surface of the lower end. A battery is directly adhered to the outward facing surface of the mirror image of the upper end.