Flexible Pouch Nucleic Acid Analysis System
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Solution Overview
Problem
Traditional microbiology techniques for diagnosing infectious diseases are time-consuming, and while PCR has become a rapid diagnostic tool, it faces challenges with multiplex reactions and sample volume requirements, often necessitating costly secondary reactions and risking contamination.
Innovation Solution
A self-contained nucleic acid analysis pouch system that integrates cell lysis, nucleic acid preparation, and PCR amplification, using a flexible pouch with pneumatic pressure to manage reagents and samples, allowing for multiplex PCR and nested reactions within a sealed environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional microbiology techniques are used for pathogen diagnosis, then diagnostic accuracy can be achieved through various assays, but the diagnostic time is extended to days or weeks
Solution Approach 1:
The patent combines multiple diagnostic functions (cell lysis, nucleic acid extraction, PCR amplification, and detection) into a single integrated pouch system. This merging of previously separate steps into one unified device enables rapid diagnosis while maintaining accuracy, directly resolving the contradiction between diagnostic speed and accuracy.
2Adaptability or versatility
If large panels of PCR assays are run for each possible causative organism, then diagnostic coverage is improved, but the cost and complexity increase significantly
Solution Approach 1:
The pouch system is designed as a universal platform that can perform multiple PCR assays simultaneously using the same basic infrastructure. The system can detect various pathogens (bacteria, viruses, fungi) through a standardized process, allowing broad diagnostic coverage without proportionally increasing complexity. This multi-functionality resolves the contradiction between versatility and complexity.
3Productivity
If multiplex PCR is used to assay multiple targets concurrently, then sample volume requirements are reduced and diagnostic efficiency is improved, but the robustness of reactions decreases and analysis becomes more difficult
Solution Approach 1:
The pouch system segments the multiplex PCR process into distinct functional zones: a reaction zone for amplification, a separation zone for product differentiation, and a detection zone for analysis. This spatial segmentation maintains reaction robustness by providing dedicated areas for each function, preventing the interference that typically reduces multiplex PCR reliability while preserving diagnostic efficiency.
4Reliability
If nested secondary PCR reactions are performed to increase robustness, then diagnostic reliability is improved, but the risk of contamination and operational complexity increase
Solution Approach 1:
The pouch system implements nested secondary reactions within the sealed pouch environment, where inner reaction chambers are contained within the outer pouch structure. This nested design maintains reliability through sequential amplification while preventing contamination by keeping all reactions confined within the sealed pouch, eliminating the need for open handling that would increase contamination risk.
5Reliability
If a sealed pouch system is used to integrate multiple diagnostic steps, then contamination risk is reduced and diagnostic speed is improved, but the device complexity increases
Solution Approach 1:
The patent uses a flexible pouch made of thin film materials to create a sealed, disposable diagnostic system. This flexible shell approach provides contamination resistance through sealing while keeping the overall device complexity manageable through the use of simple, flexible materials rather than complex rigid components. The pouch integrates multiple functions within a single flexible structure, resolving the contradiction between reliability and complexity.
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
This system enables efficient, rapid, and robust nucleic acid analysis, reducing contamination risks and improving diagnostic speed by integrating multiple steps in a sealed, flexible pouch, facilitating the detection of multiple pathogens from limited samples.
Implementation Method 1
placing the tongue into the opening of the top surface to sealably close the opening pressurizes the interior vial volume, and removal of the bottom cap causes pressurized fluid to be forced into the cannula
Implementation Method 2
A filter may be located near the bottom surface of the vial body, the filter configured to filter fluid as the fluid passes into the cannula. In one embodiment, the filter has a pore size large enough to allow protozoans or other microbes to pass, but small enough to capture larger particulate matter
Data Source
AI summary
In one illustrative embodiment, a cannulated vial is provided, the cannulated vial comprising a vial body having a top surface at one end, a bottom surface at an opposite end, and exterior wall therebetween defining an interior vial volume, the top surface having an opening, a cannula extending from the bottom surface and having a first end, a second end and an outer surface therebetween defining a cannula volume, the first end in fluid communication with the interior vial volume, and a cap having a tongue, the tongue sized to sealably close the opening, the tongue further having a volume greater than or equal to the cannula volume.