Colorimetric Urinary Tract Infection Diagnosis Device

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Solution Overview

Problem

Current methods for diagnosing urinary tract infections are either time-consuming, require specialized facilities, or produce unreliable results, and there is a need for a cost-effective technique that can quickly detect bacterial presence and effective antibiotics without specialized equipment.

Innovation Solution

A liquid analysis mixture and device for colorimetric diagnosis using a vial with a water phase containing a reagent mixture of nutrient substances, a redox indicator, and a buffer system, combined with an organic phase to prevent atmospheric oxygen diffusion, allowing for rapid color change proportional to bacterial concentration, and optionally including antibiotics to test effectiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If urine culture test is used for diagnosis, then reliability of diagnosis is improved, but response time increases to approximately 48 hours

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidresponse time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention segments the diagnostic process into two distinct phases: a rapid detection phase using a colorimetric test that provides initial results within minutes to hours, and a confirmation phase using traditional culture methods. This segmentation allows the system to deliver quick preliminary diagnoses while maintaining overall diagnostic reliability through the confirmatory culture step.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention introduces an intermediary colorimetric detection system that bridges the gap between rapid dipstick testing and slow culture methods. This intermediary system uses chromogenic substrates that change color in the presence of specific bacteria, providing a middle-ground solution that delivers results much faster than culture while being more reliable than dipstick alone.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If dipstick test is used for quick testing, then response time is reduced to approximately 120 seconds, but measurement precision deteriorates with false negative and positive results

Engineering Contradiction:
Improveresponse timeVSAvoiddiagnostic accuracy
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The invention creates a more sophisticated version of the dipstick test by using chromogenic substrates that specifically change color in response to bacterial metabolism. Instead of simply copying the dipstick approach, it enhances it by incorporating substrates that are metabolized by bacteria to produce detectable color changes, thereby improving precision while maintaining speed.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The invention utilizes color changes as the primary detection mechanism, but improves upon traditional dipstick by using chromogenic substrates that undergo specific metabolic transformations. The color change is directly linked to bacterial activity rather than just chemical presence, significantly improving diagnostic accuracy while maintaining rapid response time.

Inventive Principle:
Principle #32Color changes

3Loss of time

If serum biomarker testing is used for quick diagnosis, then response time is reduced to a few minutes, but reliability deteriorates and cannot ensure the reliability needed for urinary tract infections diagnosis

Engineering Contradiction:
Improveresponse timeVSAvoiddiagnostic reliability
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The invention replaces the biochemical detection approach of serum biomarker testing with a direct bacterial culture and detection system. Instead of measuring indirect markers in serum, the system directly detects bacterial presence and activity in urine through chromogenic substrates, maintaining rapid response while significantly improving reliability for UTI diagnosis.

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

4Reliability

If traditional urine culture test is used, then diagnostic reliability is improved, but device complexity increases requiring specialized facilities and staff

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidfacility complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention employs disposable test devices containing pre-formulated chromogenic substrates and culture media. These single-use devices eliminate the need for complex, expensive, and difficult-to-maintain laboratory equipment. The disposable nature ensures sterility and reliability while dramatically simplifying the infrastructure requirements, allowing the test to be performed in less specialized settings.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The invention changes the physical and chemical parameters of the culture medium by incorporating chromogenic substrates that automatically indicate bacterial growth through color changes. This parameter change eliminates the need for complex spectrophotometric equipment or specialized staff interpretation, as the results become visually apparent, thereby reducing facility complexity while maintaining reliability.

Inventive Principle:
Principle #35Parameter changes

5Ease of operation

If dipstick test is used, then ease of operation is improved being extremely simple, but manufacturing precision deteriorates leading to false results

Engineering Contradiction:
Improveoperational simplicityVSAvoidreagent consistency
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The invention performs preliminary preparation of the reagents by pre-formulating chromogenic substrates and culture media in stable, ready-to-use formats within disposable devices. This preliminary action ensures consistent reagent composition and sterility before the test is performed, eliminating variability in manufacturing while maintaining the simplicity of operation for the end user.

Inventive Principle:
Principle #10Preliminary 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 quick, reliable, and cost-effective diagnosis of urinary tract infections by accurately measuring bacterial load and identifying effective antibiotics, with results visible within minutes to hours, overcoming the limitations of existing methods.

Implementation Method 1

a redox indicator with a potential ranging from -100 to +500 mV... In the presence of bacteria, and in a time proportional to the bacterial concentration, the redox indicator will go from the oxidised state to the reduced state, therefore changing the colour of the solution

Methodology Applied
Scientific EffectRedox indicator color change: Redox Reactions

Implementation Method 2

an organic part immiscible with the water part and having a lower density than the same... combined with an organic phase to prevent atmospheric oxygen diffusion

Methodology Applied
Scientific EffectGas barrier prevention: Diffusion Barrier

Data Source

PatentEP3433606B1Device and liquid composition for the diagnosis of urinary tract infections
Publication Date: 2020.06.17 MBS DIAGNOSTICS LTD

AI summary

A device for a colorimetric diagnosis of urinary tract infections, characterized in that it comprises at least one vial wherein a liquid analysis mixture is housed comprising a water part and an organic part immiscible with the water part and having a density lower than that of the water part. The water part is composed of a reagent mixture comprising (a) nutrient substances comprising an amino acid source selected from the group consisting of meat infusions or peptones, vegetable peptones, casein hydrolysates, tryptose, tryptones and yeast extract; (b) at least one redox indicator with a potential ranging from -100 to +500 mV; and (c) a buffer system able to maintain the pH in a range from 6.0 to 8.0. The reagent mixture comprises from 94.0 to 99.9% by weight of the nutrient substances and from 0.1 to 6.0% by weight of the redox indicator.