Multi-layered Urine Test Device with Control Layer

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Solution Overview

Problem

Current urine testing methods require careful monitoring and can produce inaccurate results due to oxidation reactions and multiple urine insults, especially in uncontrolled environments, making them unsuitable for consumer-based applications and particularly challenging for collecting samples from vulnerable subjects like children and the elderly.

Innovation Solution

A multi-layered device with a sensing layer and a control layer is integrated into an absorbent article, where the control layer inhibits unwanted reactions by diffusive movement of control reagents, maintaining the accuracy of test results over time and reducing the need for constant monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If urine samples are left in air or oxidizing environments for extended periods, then the testing device becomes easier to use without monitoring, but oxidation reactions occur causing false positive results

Engineering Contradiction:
Improveease of use without monitoringVSAvoidaccuracy of test results
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary anti-action by incorporating control layers with reagents that preemptively counteract oxidation reactions and other unwanted chemical reactions before they can cause false results. The control layers are positioned to interact with the test sample and analytes, preventing harmful oxidation processes from occurring during the extended reading period.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The control layers act as intermediaries between the test sample and the environment. These layers contain reagents that mediate the chemical reactions, allowing the test to remain stable without monitoring by continuously counteracting oxidative effects through controlled chemical interactions.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If a controlled reading window is required for accurate results, then measurement precision is improved, but the device complexity and monitoring requirements increase

Engineering Contradiction:
Improveprecision of analyte detectionVSAvoidcomplexity of monitoring requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The testing device applies self-service by incorporating control layers that automatically maintain reaction conditions within the optimal reading window without external monitoring. The control reagents self-regulate the chemical environment, extending the valid reading period while maintaining precision through autonomous chemical control.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent utilizes parameter changes by modifying the chemical environment through control layers that adjust pH, oxidation state, and other reaction parameters. These controlled parameter changes extend the time window during which accurate readings can be obtained without requiring external monitoring or intervention.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If multiple urine insults are present in the sample, then the device must handle various interfering substances, but this affects the accuracy of test results

Engineering Contradiction:
Improveability to handle various urine conditionsVSAvoidaccuracy of analyte detection
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The control layers apply the extraction principle by selectively removing or neutralizing interfering substances from the test sample. The control reagents are designed to extract harmful elements such as oxidizing agents and other urine insults, separating them from the analyte detection process to preserve measurement accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

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

The device provides stable and accurate detection of analytes in urine samples, including urinary tract infections, without requiring careful monitoring, ensuring reliable results even in uncontrolled environments and extending the period for valid readings.

Implementation Method 1

The control layer is in fluid communication with and vertically adjacent to the sensing layer and includes a reagent capable of inhibiting the reaction at the sensing layer by diffusive movement of the reagent from the control layer to the sensing layer

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS9194807B2Multi-layered devices for analyte detection
Publication Date: 2015.11.24 KIMBERLY CLARK WORLDWIDE INC
  • US9194807B2 patent drawing
  • US9194807B2 patent drawing
  • US9194807B2 patent drawing

AI summary

A multi-layered device for detecting the presence or absence of an analyte within a test sample is described. The device includes a sensing layer and a control layer. The sensing layer is configured to support a reaction so as to exhibit a signal indicative of the presence or absence of the analyte in the test sample. The control layer is in fluid communication with and vertically adjacent to the sensing layer and includes a reagent capable of inhibiting the reaction and/or other unwanted side reactions at the sensing layer after a certain period of time by diffusive movement of the reagent from the control layer to the sensing layer.