Digital Microfluidic Cartridge with Paper Substrate for Rapid Diagnostics

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Solution Overview

Problem

Conventional methods for diagnosing infectious diseases in outpatient settings are slow, often taking days to provide results, leading to improper initial diagnoses, unnecessary prescriptions, and potential progression of treatable illnesses, while rapid diagnostic tests lack sensitivity and specificity, contributing to antibiotic resistance.

Innovation Solution

A specimen delivery cartridge system that integrates a paper testing substrate with electrodes and a digital microfluidic circuit, allowing for point-of-care analysis using a smartphone, enabling rapid and accurate differentiation between bacterial and viral pathogens by interacting magnetic particles with test specimens and using a computing device for analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional centralized laboratory testing methods are used, then diagnostic accuracy is improved, but testing time increases significantly

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The testing system is segmented into modular components: a specimen delivery cartridge containing the testing substrate, a separate computing device for image capture and analysis, and magnetic particle reagents. This segmentation allows the complex diagnostic function to be distributed across simple, portable components that can be used outside centralized laboratories while maintaining diagnostic accuracy through the sophisticated image processing algorithms running on the computing device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A lens assembly acts as an intermediary optical element between the test areas on the substrate and the image sensor of the computing device. This intermediary component enables high-quality image capture of the test results using off-the-shelf computing devices, bridging the gap between simple point-of-care testing and sophisticated digital image analysis that would otherwise require specialized laboratory equipment.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If rapid diagnostic tests are used, then testing time is reduced, but sensitivity and specificity deteriorate

Engineering Contradiction:
Improvetesting timeVSAvoidsensitivity and specificity
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The system replaces traditional optical detection methods with magnetic particle-based detection. Magnetic particles provide stronger and more specific signals than conventional rapid test reagents, enabling high sensitivity and specificity readings to be captured quickly by the image sensor. This substitution of detection mechanism allows rapid testing without sacrificing diagnostic precision.

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

Solution Approach 2:

The testing substrate uses printed electrodes and conductive traces that replicate complex laboratory testing circuits in a simplified, portable format. This copying of laboratory testing functionality onto a compact printed substrate enables gold-standard diagnostic accuracy to be achieved in a rapid point-of-care setting without requiring actual laboratory equipment.

Inventive Principle:
Principle #26Copying

3Measurement precision

If sophisticated diagnostic testing is performed, then diagnostic accuracy is improved, but device complexity increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The testing substrate utilizes a porous paper or membrane material that naturally provides fluid distribution and reaction pathways. This porous structure eliminates the need for complex microfluidic channels, pumps, or valves, achieving sophisticated diagnostic functionality through the inherent properties of the porous material while keeping the device simple and manufacturable.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The system changes the physical state and properties of reagents by using magnetic particles with specific magnetic susceptibilities that can be manipulated by external magnetic fields. This parameter change approach allows complex diagnostic functions to be achieved through simple magnetic field application rather than complex mechanical or chemical systems, reducing device complexity while maintaining diagnostic accuracy.

Inventive Principle:
Principle #35Parameter changes

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

Enables rapid, accurate, and gold-standard diagnosis during the patient visit, reducing unnecessary prescriptions and antibiotic overuse, thereby improving health outcomes and combating antibiotic resistance.

Implementation Method 1

a paper testing substrate. The paper testing substrate may include a wicking conduit

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

interacting a plurality of magnetic particles with a test specimen in a specimen delivery chamber to form magnetic test particles

Methodology Applied
Scientific EffectMagnetic interaction: Magnetism

Implementation Method 3

a lens assembly proximate the plurality of test areas and operable to transmit light emissions from the plurality of test areas to an image sensor

Methodology Applied
Scientific EffectLight transmission: Lens

Data Source

PatentUS10436781B2Point-of-care diagnostic cartridge having a digital micro-fluidic testing substrate
Publication Date: 2019.10.08 PARATUS DIAGNOSTICS LLC
  • US10436781B2 patent drawing
  • US10436781B2 patent drawing
  • US10436781B2 patent drawing

AI summary

A specimen delivery cartridge includes a lower housing, and an upper housing. The upper housing is coupled to the lower housing at a hinge. The specimen delivery cartridge further comprises a testing chamber comprising a paper testing substrate. The paper testing substrate may include a wicking conduit and a plurality of test areas. The specimen delivery cartridge may also include a lens assembly proximate the plurality of test areas and operable to transmit light emissions from the plurality of test areas to an image sensor of a computing device. In some embodiments, the specimen delivery cartridge includes a testing substrate having a plurality of test areas made of an array of electrodes. Each electrode is printed on a first side of the testing substrate and coupled to a conductive via formed in the testing substrate and a conductive trace printed on a second, opposing side of the testing substrate.