Extended Wear ECG Patch With Flexible Backing And Strain Relief
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Solution Overview
Problem
Conventional ECG monitoring systems are cumbersome, costly, and limited in duration, making long-term ambulatory monitoring impractical, especially for women, due to skin irritation, electrode dislodgment, and interference from breast anatomy, which affects the quality and reliability of atrial signal recordings.
Innovation Solution
A wearable extended wear electrocardiography patch with a flexible, adhesive-backed electrode design that includes a strain relief system and a removable reusable monitor recorder, optimized for placement on the sternum to improve comfort and signal capture, allowing for long-term monitoring without constant electrode repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If conventional ECG electrodes are used for long-term monitoring, then monitoring duration can be extended, but skin irritation and electrode dislodgment occur
Solution Approach 1:
The electrode patch is divided into multiple independent electrode elements (first electrode, second electrode, third electrode) distributed across the chest surface. This segmentation allows the monitoring function to be distributed across multiple small contact points rather than one large electrode, reducing skin irritation while maintaining monitoring duration.
Solution Approach 2:
A flexible substrate serves as an intermediary between the electrodes and the skin surface. This substrate can conform to the chest contours and accommodate breast anatomy, providing a buffer that reduces direct pressure and irritation while maintaining stable electrode-skin contact for extended periods.
2Duration of action of stationary object
If conventional ECG electrodes are used for long-term monitoring, then monitoring duration can be extended, but electrode dislodgment occurs
Solution Approach 1:
The electrode patch is designed with a curved or contoured flexible substrate that conforms to the three-dimensional contours of the chest surface. This curvature allows the electrodes to maintain consistent contact with the skin despite patient movement, breathing, or posture changes, preventing dislodgment during long-term monitoring.
Solution Approach 2:
The flexible substrate of the electrode patch is designed to be dynamically adaptable, allowing it to flex and move with the patient's body during normal activities. This dynamic flexibility maintains electrode-skin contact stability throughout the monitoring period, preventing dislodgment while enabling extended wear.
3Ease of operation
If breast anatomy is present, then patient comfort may be improved, but signal recording quality deteriorates
Solution Approach 1:
The electrode patch employs different electrode types at different locations: non-invasive electrodes are positioned on the chest surface away from breast tissue, while invasive electrodes can be positioned between the breasts if needed. This local differentiation allows the system to maintain signal quality by selecting optimal electrode positions based on the patient's anatomy while preserving comfort.
Solution Approach 2:
The electrode patch utilizes the third dimension (depth/layering) by positioning electrodes at different depths and orientations. Non-invasive electrodes contact the skin surface, while invasive electrodes can penetrate between breast tissues to reach the chest wall, effectively using vertical dimensionality to bypass anatomical obstructions and improve signal quality without compromising comfort.
4Reliability
If rigid ECG electrodes are used, then signal stability is improved, but patient mobility and comfort deteriorate
Solution Approach 1:
The electrode patch uses a flexible thin-film substrate that can bend and conform to the patient's body movements. This flexibility allows patients to move freely during daily activities while the electrodes maintain stable contact with the skin, achieving both signal stability and patient mobility that would be incompatible with rigid electrodes.
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
Enhances the quality and duration of ECG recordings, improving arrhythmia diagnosis by maintaining consistent skin contact and reducing discomfort, particularly for women, through a design that accommodates breast anatomy and minimizes electrode dislodgment.
Implementation Method 1
A layer of stretchable adhesive is applied on at least a portion of a contact surface of the flexible backing
Implementation Method 2
Conductive gel is provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes
Implementation Method 3
The flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending
Data Source
AI summary
An extended wear electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable spunlace material. A layer of stretchable adhesive is applied on at least a portion of a contact surface of the flexible backing, which defines a pair of openings on both ends. A non-stretchable circuit is axially affixed to an outward-facing surface of the flexible backing and has a pair of circuit traces. The flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending. A pair of electrocardiographic electrodes are electrically coupled to each of the circuit traces. Conductive gel is provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes as the electrodes shift away from the openings in the flexible backing during the bending.