Automated Urine Diagnostic System for High-Throughput Screening

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Solution Overview

Problem

Current point-of-care urine testing in emergency departments is inefficient and prone to user errors, leading to unreliable results and potential harm to pregnant women, as well as undiagnosed chronic kidney disease, due to labor-intensive and time-consuming processes that are not well-suited for high-throughput screening.

Innovation Solution

A medical diagnostic system that automates the collection, processing, and analysis of urine samples using optically and electronically detectable indicators, capable of communicating results to a network-connected device, installed on toilets or other devices, to facilitate rapid and reliable testing for pregnancy and chronic kidney disease without requiring extensive clinical staff input.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual point-of-care urine testing is used, then clinical staff can perform pregnancy tests, but the process is labor-intensive and time-consuming, taking up to 65 minutes per test

Engineering Contradiction:
Improvepregnancy test accuracyVSAvoidscreening throughput
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent replaces manual mechanical operations with an automated system that uses pumps, valves, and fluid transport mechanisms to move urine samples through testing chambers. The system automatically dispenses reagents, mixes samples, and transports fluids through capillary channels, eliminating the need for manual manipulation and significantly reducing testing time while maintaining accuracy.

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

Solution Approach 2:

The testing device is designed to perform operations autonomously without requiring clinical staff intervention. The system self-regulates fluid flow through pressure differentials, automatically mixes reagents with samples, and transports processed samples to waste containers. This self-service capability enables high-throughput screening while reducing labor requirements.

Inventive Principle:
Principle #25Self-service

2Ease of operation

If manual urine collection and testing procedures are used, then pregnancy screening can be performed, but user errors such as misplacement and mislabeling of samples lead to unreliable results

Engineering Contradiction:
Improvetesting simplicityVSAvoidtest result accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system replaces manual sample handling with automated fluid transport mechanisms that use pressure differentials and capillary action to move samples through defined pathways. This eliminates human errors in sample placement and tracking, ensuring that each sample follows a predetermined route from collection to analysis and waste disposal.

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

Solution Approach 2:

The patent introduces an automated control system that acts as an intermediary between sample collection and analysis. This system manages the entire testing process, including reagent dispensing, sample mixing, and result interpretation, thereby eliminating user errors in test execution and result documentation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If home pregnancy tests are used in emergency departments, then testing can be performed, but they are not designed for high throughput and rapid mass screening

Engineering Contradiction:
Improvetesting flexibilityVSAvoidscreening capacity
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The testing system is divided into multiple independent testing chambers that can simultaneously process different samples. Each chamber contains its own reagent reservoirs and fluid pathways, allowing parallel processing of multiple urine samples. This segmented architecture enables high-throughput screening while maintaining the simplicity of individual test operations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The automated system is designed to perform multiple functions within a single device, including sample collection, reagent dispensing, mixing, incubation, and result analysis. This multi-functional capability allows the device to handle various testing scenarios and sample types, providing both flexibility and high throughput in the emergency department setting.

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

4Reliability

If extensive clinical staff input is required for urine testing, then proper testing procedures can be followed, but the process becomes time-consuming and labor-intensive

Engineering Contradiction:
Improvetesting complianceVSAvoidtesting duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system is designed to autonomously perform all testing operations without requiring clinical staff intervention. The automated control system manages reagent dispensing, sample processing, and result interpretation, ensuring proper testing procedures are followed while eliminating the time loss associated with manual operations and staff training requirements.

Inventive Principle:
Principle #25Self-service

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 system significantly reduces testing time, increases screening efficiency, and improves reliability, potentially doubling the number of women screened without increasing costs, while minimizing errors and ensuring more accurate results.

Implementation Method 1

a fluid transportation system configured to transport a portion of the urine sample from the collection component to a first test strip

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a sensor configured to capture an image of the first test strip exposed to the portion of the urine sample

Methodology Applied
Scientific EffectOptical detection: Absorption Spectroscopy

Data Source

PatentUS20220308040A1Medical Diagnostic System and Method
Publication Date: 2022.09.29 EVERYPLACE LABS INC
  • US20220308040A1 patent drawing
  • US20220308040A1 patent drawing
  • US20220308040A1 patent drawing

AI summary

A medical diagnostic system is provided to automate analysis of samples to predict a medical condition, such as pregnancy or chronic kidney disease. The system may provide test strip usage automation. The medical diagnostic system may include a sample collection component, collection cup contamination protection mechanism, sample volume control component, test strip reader component, which may be manifested as a lateral flow strip reader, flow reader, sample analytic component, data processing component, data communication component, networked data management component, and device cleaning mechanism. A method to automate analysis of samples to predict a medical condition using the medical diagnostic system is also provided.