Microfluidic Nucleic Acid Cartridge for Parallel PCR Sample Prep

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Solution Overview

Problem

Current in vitro diagnostic analyses are bottlenecked due to the need for specialized equipment and centralized facilities, leading to delays and inefficiencies in sample processing and analysis, particularly in preparing biological samples for PCR and nucleic acid testing.

Innovation Solution

A microfluidic cartridge-based system that enables automated sample preparation and diagnostic analysis, allowing for parallel processing of multiple samples without the need for centralized facilities, using a processor-controlled apparatus with integrated heating, separation, and detection capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If specialized equipment and centralized facilities are used for diagnostic analyses, then measurement precision and reliability are improved, but device complexity and loss of time increase

Engineering Contradiction:
Improvediagnostic analysis accuracyVSAvoidsample processing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system divides the diagnostic analysis process into modular functional units including sample processing module, nucleic acid extraction module, PCR amplification module, and detection module. Each module can operate independently and in parallel, enabling simultaneous processing of multiple samples while maintaining diagnostic accuracy through specialized functionality in each segment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from centralized batch processing to distributed parallel processing by implementing a multi-lane microfluidic cartridge system with multiple independent reaction channels. This dimensional expansion allows simultaneous execution of multiple diagnostic tests across different samples, effectively reducing overall processing time while maintaining measurement precision through dedicated detection for each lane.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Productivity

If batch processing is used for samples, then device complexity is reduced, but productivity and loss of time worsen

Engineering Contradiction:
Improvesamples processed per hourVSAvoidprocessing system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system merges multiple sample processing functions into a single integrated microfluidic cartridge that handles nucleic acid extraction, amplification, and detection for multiple samples simultaneously. This consolidation increases productivity by processing approximately 45 samples per hour through parallel operations while managing device complexity through unified control architecture and standardized cartridge design.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The microfluidic cartridge is designed as a universal platform capable of processing multiple different sample types and performing various nucleic acid-based diagnostic tests through configurable reaction conditions. The same physical device can handle different pathogens and genetic analyses by adjusting amplification parameters and detection settings, thereby increasing overall system productivity without requiring separate specialized equipment for each test type.

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

3Measurement precision

If samples are sent to centralized facilities, then measurement precision is improved, but loss of time and loss of substance increase

Engineering Contradiction:
Improvenucleic acid detection accuracyVSAvoidsample loss during shipping
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The system enables point-of-care testing by bringing the complete diagnostic capability to the location where samples are collected. The self-contained microfluidic cartridge performs nucleic acid extraction, amplification, and detection locally without requiring sample transport to centralized facilities, thereby eliminating sample loss during shipping while maintaining detection accuracy through integrated specialized components.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The microfluidic cartridge acts as an intermediary device that bridges the gap between simple point-of-care equipment and complex centralized laboratory systems. It incorporates specialized components for accurate nucleic acid detection within a portable format, allowing local processing to achieve laboratory-quality results without the harmful effects of sample transport including loss, contamination, and delays.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Productivity

If manual sample preparation is used, then device complexity is reduced, but productivity and loss of time worsen

Engineering Contradiction:
Improvesample preparation throughputVSAvoidautomation system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system replaces manual mechanical sample preparation operations with automated microfluidic processes that use integrated pumps, valves, and mixing chambers to perform nucleic acid extraction and sample processing. This substitution increases productivity by eliminating manual handling steps and enabling parallel processing of multiple samples while managing complexity through integrated control systems and pre-configured cartridge designs.

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

Solution Approach 2:

The microfluidic cartridge is designed to perform sample preparation operations autonomously once samples are loaded. Integrated reagent reservoirs, automated mixing chambers, and built-in purification steps allow the system to prepare samples without external intervention, thereby increasing throughput significantly while keeping the automation complexity contained within the disposable cartridge rather than the main instrument.

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

Enables rapid and efficient analysis of nucleic acids from biological samples, capable of processing approximately 45 samples per hour, with results available in under an hour, and allows for on-demand testing at the point of care, reducing shipping and handling issues.

Implementation Method 1

a heater unit configured to heat the process tube

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 2

a magnetic separator configured to separate magnetic particles from a solution

Methodology Applied
Scientific EffectMagnetic separation: Magnetic Field

Data Source

PatentEP3178558B1Intergrated apparatus for performing nucleic acid extraction and diagnostic testing on multiple biological samples
Publication Date: 2022.03.30 HANDYLAB INC
  • EP3178558B1 patent drawingFigure 1A
  • EP3178558B1 patent drawingFigure 1B
  • EP3178558B1 patent drawingFigure 2

AI summary

The technology described herein generally relates to systems for extracting polynucleotides from multiple samples, particularly from biological samples, and additionally to systems that subsequently amplify and detect the extracted polynucleotides. The technology more particularly relates to microfluidic systems that carry out PCR on multiple samples of nucleotides of interest within microfluidic channels, and detect those nucleotides.