Amniotic Fluid Diagnostic Composition Eliminating Urine Interference

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Solution Overview

Problem

Current diagnostic systems for detecting amniotic fluid leakage often result in false positives due to interference from urine, requiring lengthy evaluation times and potentially leading to unnecessary stress and hospitalization, as they rely on pH checks that can be influenced by drying and wetting cycles.

Innovation Solution

A diagnostic composition comprising polymers, a tri-ester non-cyclic plasticizer, a hydrophilic non-ionic polymer surfactant, an aromatic carboxylic acid, and an ion-balance reagent, devoid of a wetting agent, which allows for immediate detection of amniotic fluid without drying time, reducing false positives and enabling self-diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pH checking methods are used to detect amniotic fluid, then detection capability is provided, but false positives occur due to urine interference and drying-wetting cycle influences

Engineering Contradiction:

Improvedetection accuracyVSAvoidfalse positive rate

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent changes the detection parameter from pH (which is affected by urine interference and drying-wetting cycles) to a colorimetric reaction based on the indicator system interacting with amniotic fluid components. This parameter change eliminates false positives caused by urine presence and drying-wetting cycle variations, while maintaining reliable detection of amniotic fluid leakage.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces an intermediary indicator system that mediates between the amniotic fluid and the detection mechanism. The indicator system provides a specific colorimetric response when interacting with amniotic fluid components, allowing reliable differentiation from urine and other vaginal secretions without being affected by drying-wetting cycles.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If traditional diagnostic articles are used, then amniotic fluid detection is possible, but lengthy evaluation time is required

Engineering Contradiction:

Improvedetection capabilityVSAvoidevaluation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent incorporates the indicator system and polymers in advance within the diagnostic article structure, allowing immediate colorimetric detection upon contact with amniotic fluid. The preliminary preparation of the indicator system enables rapid evaluation without requiring lengthy waiting periods, while maintaining reliable detection capability.

Inventive Principle:

Principle #10Preliminary action

3Adaptability or versatility

If pH determining members are used, then differentiation between fluids is attempted, but false positives occur due to urine interference

Engineering Contradiction:

Improvefluid differentiation capabilityVSAvoidfalse positive rate

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent changes the detection mechanism from pH measurement to a colorimetric reaction system that specifically interacts with amniotic fluid components. This parameter change provides reliable fluid differentiation without false positives from urine interference, as the indicator system responds specifically to amniotic fluid characteristics rather than general pH changes.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces an intermediary indicator system that mediates the interaction between the diagnostic article and biological fluids. This indicator system provides specific colorimetric responses that enable reliable differentiation between amniotic fluid and urine, eliminating false positives while maintaining fluid differentiation capability.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Reliability

If diagnostic articles requiring drying time are used, then detection can be performed, but time to diagnosis is extended

Engineering Contradiction:

Improvedetection accuracyVSAvoiddiagnosis speed

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent incorporates the indicator system and polymers in advance within the diagnostic article, enabling immediate colorimetric detection upon contact with amniotic fluid. The preliminary preparation eliminates the need for drying time, allowing rapid evaluation while maintaining reliable detection accuracy.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent enables continuous colorimetric detection action from the moment of contact with amniotic fluid, without interruption for drying periods. The indicator system continuously interacts with the fluid components, providing immediate and reliable detection results that accelerate the diagnosis process while maintaining accuracy.

Inventive Principle:

Principle #20Continuity of useful action

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 solution provides a rapid, reliable, and accurate method for differentiating amniotic fluid from urine, minimizing false positives and allowing for immediate self-detection, thereby reducing the time to diagnosis and alleviating patient stress.

Implementation Method 1

The pH determining member includes a chemical composition which reacts with fluids containing urea differently than with fluids that do not contain urea

Methodology Applied

Scientific EffectpH change:

Implementation Method 2

chromatographic detection of a color change in a diagnostic article following contact with vaginal secretion

Methodology Applied

Scientific EffectColor change:

Implementation Method 3

a hydrophobic chemical composition that reacts with fluids based on the buffer capacity thereof, such that fluids having different buffer capacities can be distinguished

Methodology Applied

Scientific EffectBuffer capacity reaction: