Flexible Endometrial Electrode Array for Direct Uterine Monitoring

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Solution Overview

Problem

Current methods for monitoring uterine activity and endometrial cavity conditions are limited, particularly for non-pregnant women, and do not allow for continuous, long-term, direct measurement of electrical and chemical parameters, making it difficult to predict preterm labor, assess fertility, and diagnose uterine pathologies effectively.

Innovation Solution

A method involving a medical device with electrode and sensing arrays that can be positioned within the endometrial cavity to monitor electrical, chemical, and physical parameters, allowing for continuous data collection and stimulation, enabling precise analysis of uterine activity and fertility assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If external transducers are placed on the abdomen to monitor uterine activity, then monitoring can be performed non-invasively, but measurement precision deteriorates due to skin thickness and obesity

Engineering Contradiction:
Improvenon-invasive monitoringVSAvoiduterine activity detection accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The device segments the monitoring function by placing separate electrodes at multiple locations within the uterine cavity (fundus, body, cervix) rather than using a single external transducer. This segmentation allows direct measurement of electrical activity at different uterine regions, improving measurement precision while maintaining ease of operation through minimally invasive placement

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary approach by using the uterine cavity itself as the measurement medium. Instead of measuring through the abdominal wall (external transducer), the system uses electrodes placed within the cavity to directly detect electrical activity, eliminating the barrier of skin and subcutaneous tissue that degrades signal quality

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If vaginal devices are inserted to establish electrical connection with the cervix, then electrical activity can be monitored, but continuous long-term monitoring is limited

Engineering Contradiction:
Improveelectrical activity monitoringVSAvoidcontinuous monitoring duration
Core Design Contradiction:
Measurement precisionVSDuration of action of stationary object

Solution Approach 1:

The device incorporates flexible cables and adaptable electrode positions that can move with uterine contractions and cervical changes. This dynamic design allows the electrodes to maintain electrical contact with the endometrial cavity throughout the menstrual cycle and pregnancy, enabling continuous monitoring for extended periods without dislodgement or loss of signal quality

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system is designed to serve multiple functions across different time periods: monitoring electrical activity during the menstrual cycle, tracking uterine activity during pregnancy, and detecting labor onset. This multi-functionality allows a single device placement to provide continuous monitoring throughout various physiological states, extending the duration of useful monitoring

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

3Measurement precision

If multichannel electrohysterography is performed from within the uterus, then weak peristalsis signals can be detected, but device complexity increases

Engineering Contradiction:
Improveperistalsis signal detectionVSAvoidelectrode array configuration
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device segments the electrical measurement function into multiple independent electrodes positioned at different locations within the uterine cavity (fundus, body, cervix). Each electrode independently records electrical activity, and the segmented signals are later combined through signal processing to detect weak peristalsis patterns that would be invisible to a single electrode, thereby improving detection precision without requiring an overly complex single-component design

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses multiple electrodes that essentially create copies of the electrical measurement function at different spatial locations. These replicated measurement points capture variations in electrical activity across the uterine cavity, allowing detection of subtle peristalsis signals through comparison and integration of the copied signals, improving precision while keeping individual electrode design simple

Inventive Principle:
Principle #26Copying

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

Enables accurate, continuous monitoring of endometrial cavity conditions, improving the prediction of preterm labor, fertility assessment, and diagnosis of uterine pathologies, with potential for enhanced treatment and prevention of conditions like adenomyosis and endometriosis.

Implementation Method 1

receiving an electrical activity of said endometrial walls and/or cavity using at least an electrode array attached to said structural component, wherein said electrode array is in electrical contact with said endometrial walls and/or cavity

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS12102303B2Method and apparatus for direct in-vivo, electrical and chemical monitoring and stimulation of the endometrial cavity
Publication Date: 2024.10.01 GYNETRONICS LTD
  • US12102303B2 patent drawing
  • US12102303B2 patent drawing
  • US12102303B2 patent drawing

AI summary

Devices, systems and related methods for direct and in-vivo monitoring and stimulation of the endometrial cavity include a plurality of sensing modalities incorporated on a set of flexible conductive filaments that allows its insertion in an endometrial cavity through the vagina. The flexible set of conductive filaments is in direct contact with the endometrium to maximize recording sensitivity and acquire direct readings, which correspond to the functionality of the endometrium and/or electrically stimulate endometrial peristalsis in a controlled manner. The same electrodes can be used for a controlled stimulation to strengthen weakened muscle tissue before and after medical and surgical interventions on the uterus, to reset to normal contractility. The methods and systems disclosed herein can be used to improve the chances of success for artificial insemination, including in-vitro fertilization, embryo transfer, and intrauterine insemination, diagnostic tests, and may further improve the overall understanding of endometrial functionality.