Electrochemical Aptamer Sensor for Ovulation Monitoring

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Solution Overview

Problem

Current ovulation monitoring methods, particularly urine-based LH testing, are inadequate as they fail to predict ovulation accurately due to the delay between serum LH levels reaching a threshold and the detection in urine, leading to missed fertile windows, and require multiple tests for progesterone monitoring, burdening users with testing frequency.

Innovation Solution

Development of a device using electrochemical aptamer-based sensors with redox couples to measure LH and progesterone in interstitial fluid or blood, enabling continuous monitoring for extended periods through needle or microneedle-based fluid communication, allowing for precise tracking of hormone levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If urine-based LH testing is used to monitor ovulation, then pregnancy rates can be improved from 30% to 43%, but the accuracy of ovulation prediction deteriorates because 19% of women ovulate before their urine-based LH test turns positive

Engineering Contradiction:
Improvepregnancy rateVSAvoidovulation prediction accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent introduces an intermediary device (micro-needle patch with sensor) that bridges the gap between blood and urine testing. The micro-needles penetrate the skin to access interstitial fluid, which serves as an intermediary medium containing LH and progesterone analytes, enabling more accurate monitoring while maintaining ease of use.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/chemical urine testing system with an electrochemical sensing system. Instead of using lateral flow assays that require manual urine application, the invention uses electrochemical sensors that automatically detect LH and progesterone levels in interstitial fluid through electrochemical reactions, providing continuous monitoring without manual intervention.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If multiple urine tests are performed to capture progesterone rise and peak, then progesterone monitoring accuracy is improved, but the testing burden on women increases

Engineering Contradiction:
Improveprogesterone monitoring accuracyVSAvoidtesting burden
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent implements continuous monitoring of progesterone levels through the micro-needle patch device. Instead of requiring discrete multiple tests throughout the cycle, the sensor continuously measures progesterone in interstitial fluid, capturing the rise and peak without requiring the user to perform repeated manual testing actions.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The device performs self-service by automatically accessing interstitial fluid through micro-needles and continuously measuring hormone levels without requiring the user to collect urine samples or manually apply test strips. The system autonomously monitors both LH and progesterone, eliminating the manual testing burden while maintaining measurement precision.

Inventive Principle:
Principle #25Self-service

3Duration of action of moving object

If in-dwelling sensors or micro-needles are used for continuous glucose monitoring in interstitial fluid, then continuous measurement capability is achieved, but the complexity of the device increases

Engineering Contradiction:
Improvecontinuous measurement durationVSAvoidsensor insertion complexity
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The patent segments the monitoring function into separate modular components: micro-needles for fluid access, electrochemical sensors for analyte detection, and a processing unit for data analysis. This segmentation allows the use of simple, well-established technologies for each function rather than a single complex integrated system, reducing overall device complexity while enabling continuous measurement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The micro-needle patch device is designed to be universal by incorporating sensors that can detect multiple analytes (LH and progesterone) using the same basic platform. The electrochemical sensor array can monitor different hormones through selective recognition elements, providing multi-functionality without requiring separate devices for each hormone, thus reducing complexity compared to multiple specialized systems.

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

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

This solution provides accurate and continuous monitoring of LH and progesterone levels, enhancing the prediction of ovulation and peak fertility, reducing the burden of frequent testing and improving the detection of ovulation timing.

Implementation Method 1

at least one electrochemical aptamer-based (EAB) sensor using one or more attached redox couples that measure at least one of said analytes

Methodology Applied
Scientific EffectElectrochemical detection:

Implementation Method 2

using one or more attached redox couples that measure at least one of said analytes

Methodology Applied
Scientific EffectRedox reactions: Redox Reactions

Implementation Method 3

the needle is hollow and couples interstitial fluid or blood to the at least one sensor by diffusion

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

the needle is hollow and couples interstitial fluid or blood to the at least one sensor by advection

Methodology Applied
Scientific EffectAdvection: Advection

Data Source

PatentUS20240215904A1Ovulation Monitoring Platform
Publication Date: 2024.07.04 UNIVERSITY OF CINCINNATI
  • US20240215904A1 patent drawing
  • US20240215904A1 patent drawing
  • US20240215904A1 patent drawing

AI summary

A device for measuring one or more analytes in a sample of interstitial fluid or blood is provided. The device comprises at least one EAB sensor using one or more attached redox couples that measure at least one of the analytes. It also includes at least one means to establish fluid communication between the sensor and the sample. The analytes are selected from the group consisting of progesterone, luteinizing hormone (LH), estrogen, follicle stimulating hormone (FSH), their metabolites, and combinations thereof.