Insertable Cardiac Monitor P-Wave Detection via Disposable Electrodes
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Solution Overview
Problem
Conventional electrocardiographic monitoring systems, including insertable cardiac monitors (ICMs), face challenges in reliably recording atrial signals, particularly the low-amplitude P-wave, due to small size, signal processing limitations, and poor electrode configuration, leading to inadequate diagnostic capabilities for cardiac rhythm disorders.
Innovation Solution
A wearable monitor with a flexible extended wear electrode patch and a reusable monitor recorder, optimized for long-term ECG recording, featuring a unique 'hourglass' shape for improved wearability and comfort, and a subcutaneously implantable cardiac monitor with specifically designed electrodes and circuitry to capture low-amplitude P-wave signals, allowing for extended and accurate atrial activity monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If conventional ECG electrodes are used for long-term monitoring, then monitoring duration can be extended, but electrode adhesion deteriorates and signal quality decreases
Solution Approach 1:
The patent employs disposable adhesive patches with integrated electrodes that are designed for single-use over extended periods (30 days or longer). These patches are discarded after use rather than reused, ensuring consistent signal quality without the adhesion deterioration problems of reusable electrodes. The disposable nature eliminates skin irritation from repeated adhesive application while maintaining reliable contact throughout the monitoring period.
2Duration of action of moving object
If conventional ECG electrodes are used for long-term monitoring, then monitoring duration can be extended, but signal quality deteriorates due to skin irritation and contamination
Solution Approach 1:
Disposable patches eliminate signal degradation from skin irritation, perspiration, and contamination that accumulate during long-term use of reusable electrodes. Each new patch provides fresh adhesive and clean electrode surfaces, ensuring consistent signal quality throughout the monitoring period without the deterioration seen in reusable systems.
Solution Approach 2:
The adhesive patches utilize flexible, conformable materials that maintain intimate contact with the skin surface over extended periods. The thin-film construction allows the patch to move with the patient without creating stress concentrations that would cause dislodgment or signal loss, thereby maintaining measurement precision throughout the monitoring duration.
3Volume of moving object
If ICM size is reduced for implantation, then ease of implantation improves, but P-wave detection capability deteriorates
Solution Approach 1:
The patent divides the sensing function into separate components: the implantable portion contains minimal circuitry and electrodes, while the signal processing and analysis functions are performed externally or through integrated algorithms that optimize detection of low-amplitude P-waves despite the small sensor size. This segmentation allows the ICM to remain small while maintaining detection capability through sophisticated signal processing.
Solution Approach 2:
The patent employs signal processing parameter changes including amplification, filtering, and digital enhancement techniques to improve the detectability of P-waves from the small implantable electrodes. By modifying the electrical parameters of signal processing (gain, bandwidth, noise filtering), the system compensates for the limited signal amplitude available from miniaturized electrodes, maintaining measurement precision despite reduced sensor size.
Data Source
AI summary
Long-term electrocardiographic and physiological monitoring over a period lasting up to several years in duration can be provided through a continuously-recording insertable cardiac monitor. The sensing circuitry and the physical layout of the electrodes are specifically optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves that are generated during atrial activation and storing samples of captured signals. In general, the ICM is intended to be implanted centrally and positioned axially and either over the sternum or slightly to either the left or right of the sternal midline in the parasternal region of the chest.