Closed Sample Processing Cartridge for Automated Diagnostic Reactions

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Solution Overview

Problem

Current clinical and molecular diagnostic systems require significant sample handling and preparation, specialized equipment, and trained personnel, and lack integrated 'sample-to-answer' capabilities.

Innovation Solution

A multiplex diagnostic system with a software architecture that enables minimal sample handling and preparation, using a fluid sample processing cartridge with integrated sample extraction, amplification, and detection on a microfluidic platform, allowing for rapid analysis of multiple samples with minimal operations and no need for specialized equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If integrated sample-to-answer system is implemented, then speed of analysis and ease of operation are improved, but device complexity increases

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent integrates multiple diagnostic functions (sample preparation, extraction, amplification, and detection) into a single integrated device and cartridge system. The cartridge contains all necessary reagents, chambers, and microfluidic channels, while the device provides automated processing, eliminating the need for separate equipment for each step and reducing operational complexity despite the advanced capabilities.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system is designed as a universal platform that can process multiple sample types and perform various diagnostic assays through a single device and cartridge design. The cartridge is configured to handle different sample matrices and detection methods, providing multi-functionality without requiring specialized equipment for each application.

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

2Productivity

If multiple samples are processed rapidly, then productivity is improved, but device complexity increases

Engineering Contradiction:
ImproveproductivityVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system divides the diagnostic process into discrete modular components: the cartridge is segmented into separate chambers for sample preparation, extraction, and detection, each with dedicated microfluidic channels. This segmentation allows parallel processing of multiple samples through randomized access to different cartridge positions, enabling high productivity while maintaining manageable device complexity through modular architecture.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The cartridge is pre-loaded with all necessary reagents, consumables, and microfluidic pathways before sample introduction. Sample preparation steps are pre-configured within the cartridge, allowing rapid processing without requiring complex real-time setup or intervention, thereby improving productivity while keeping the device operationally simple.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If minimal sample handling is required, then ease of operation is improved, but manufacturing precision must be high

Engineering Contradiction:
Improveease of operationVSAvoidmanufacturing precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The cartridge is designed as a self-contained unit that automatically performs sample handling, mixing, and transport through integrated microfluidic channels. The system requires minimal user intervention beyond sample loading, as the cartridge's internal architecture autonomously manages fluid flow and processing steps. This self-service capability simplifies operation but demands high manufacturing precision in the microfluidic channel fabrication and component assembly to ensure reliable automated function.

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 provides rapid sample-to-answer results within 45-90 minutes, reducing the need for trained personnel and enabling point-of-care diagnostics with versatile sample processing capabilities.

Implementation Method 1

The deformable fluid chamber is configured to hold a fluid therein when in an un-deformed state and to collapse upon application of an external compression force to expel at least a portion of the fluid from the fluid chamber

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

The driven mixing apparatus is constructed and arranged to mix the contents of the mixing well

Methodology Applied
Scientific EffectStirring: Stirring

Data Source

PatentEP3516401B1Instrument for processing cartridge for performing assays in a closed sample preparation and reaction system
Publication Date: 2025.07.30 ROCHE DIAGNOSTICS GMBH
  • EP3516401B1 patent drawingFigure 1
  • EP3516401B1 patent drawingFigure 2
  • EP3516401B1 patent drawingFigure 3

AI summary

In one embodiment, a diagnostic system includes an instrument coupled to a client device and having at least one sample processing bay. The diagnostic system has a software architecture including instrument software (ISW) associated with the instrument. The ISW receives an assay definition file (ADF) that has a control file and an assay analysis module (AAM) file. The processing bay prepares and senses the sample according to parameters in the OPUS file and then generates sensor scan data. The diagnostic system then analyzes the sensor scan data and prepares a report according to the AAM file.