Two-Stage Microfluidic Cartridge for Multiplexed Nucleic Acid Testing

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Solution Overview

Problem

Current diagnostic assays in the medical diagnostics industry face bottlenecks due to the need for specialized, expensive equipment that is not readily available on-demand, leading to delays and inefficiencies in processing biological samples, particularly in nucleic acid amplification and detection processes.

Innovation Solution

A microfluidic cartridge with multiple sample lanes and a diagnostic apparatus that includes amplification and detection chambers, valves, and heat sources, allowing for real-time amplification and detection of nucleic acids in parallel, enabling high-throughput and multiplexed analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If specialized diagnostic equipment is used for nucleic acid amplification and detection, then measurement precision and reliability are improved, but device complexity and cost increase

Engineering Contradiction:
Improvedetection accuracyVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The diagnostic system is divided into modular components: a microfluidic cartridge containing multiple independent sample lanes with integrated amplification and detection chambers, and a separate reader device. Each lane can process different samples independently, allowing the system to maintain high measurement precision through specialized chambers while reducing overall device complexity through modularity and standardized interfaces.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The microfluidic cartridge is designed as a universal platform that can simultaneously process multiple different nucleic acid amplification reactions across its lanes. The same cartridge structure and fluidic network can accommodate various amplification protocols and detection methods, enabling one device to perform multiple diagnostic functions, thereby reducing the need for multiple specialized equipment types.

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

2Productivity

If batch processing is used for diagnostic samples, then device complexity is reduced, but productivity and speed deteriorate

Engineering Contradiction:
Improveprocessing throughputVSAvoidprocessing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The microfluidic cartridge contains multiple independent sample lanes (e.g., 12 lanes) that can process different samples simultaneously in parallel. Each lane has its own amplification and detection chambers that operate independently, allowing the system to process multiple samples at the same time rather than sequentially, thereby dramatically increasing productivity without requiring multiple separate devices.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system enables continuous processing by loading multiple cartridges into the reader device, which can then process them sequentially without idle time. The microfluidic design allows for rapid fluidic operations and quick transition between samples, maintaining continuous useful action and minimizing downtime between processing batches, thus improving overall throughput.

Inventive Principle:
Principle #20Continuity of useful action

3Productivity

If multiple samples are processed in parallel using the microfluidic cartridge, then productivity is improved, but device complexity increases

Engineering Contradiction:
Improveprocessing throughputVSAvoidmicrofluidic network complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The microfluidic cartridge is segmented into multiple independent sample lanes, each with dedicated amplification and detection chambers. This segmentation allows parallel processing of multiple samples while keeping the fluidic pathways within each lane relatively simple and manageable. The modular lane structure prevents the overall system complexity from becoming unmanageable by dividing it into repeating, standardized units.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The microfluidic cartridge merges multiple functions (sample loading, amplification, detection, and waste collection) into a single integrated device. By combining these functions in one cartridge that fits into a standardized reader, the system achieves high productivity through parallel processing while avoiding the complexity of coordinating multiple separate devices and operations.

Inventive Principle:
Principle #5Merging (Combining)

4Measurement precision

If samples are transported to centralized diagnostic locations, then measurement precision is improved, but loss of time and productivity deteriorate

Engineering Contradiction:
Improvedetection accuracyVSAvoidtransportation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The microfluidic cartridge reader is designed as a universal diagnostic device that can be deployed in various settings including point-of-care locations, remote clinics, and hospital laboratories. This universal device performs the same high-precision nucleic acid amplification and detection functions as centralized laboratory equipment, eliminating the need to transport samples to centralized locations while maintaining measurement precision.

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

Solution Approach 2:

The microfluidic cartridge acts as an intermediary that brings laboratory-quality diagnostic capabilities to decentralized locations. The cartridge contains pre-loaded reagents and optimized reaction conditions, serving as a portable intermediary that enables high-precision diagnostics without requiring sample transportation to centralized facilities, thus eliminating transportation time and delays.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Facilitates efficient, on-demand processing of multiple biological samples simultaneously, reducing delays and costs associated with sample transportation and equipment availability, while improving the throughput and accuracy of nucleic acid amplification and detection.

Implementation Method 1

The amplification valves can include a temperature responsive substance that melts upon heating to seal a channel that communicates with the amplification chamber. The detection valves can comprise a temperature responsive substance that melts upon heating in order to seal a channel that communicates with the plurality of detection chambers.

Methodology Applied
Scientific EffectMelting: Melting

Data Source

PatentUS11453906B2Multiplexed diagnostic detection apparatus and methods
Publication Date: 2022.09.27 HANDYLAB INC
  • US11453906B2 patent drawing
  • US11453906B2 patent drawing
  • US11453906B2 patent drawing

AI summary

Disclosed herein are devices configured for the amplification and detection of multiple targets from a sample, and methods of using the same. The devices disclosed herein comprise microfluidic cartridges have a first stage (amplification) and a second (detection) stage. The two-stage design of the cartridges enables testing for multiple targets within a sample, i.e., from a single nucleic acid amplification reaction. Methods for the amplification and detection of a plurality of target nucleic acids from a sample are also disclosed herein.