Disposable Cartridge Flow Control for Diagnostic Assay Cross-Contamination
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Solution Overview
Problem
Current diagnostic assay systems face challenges in sample preparation, requiring trained personnel, prone to cross-contamination, and costly manufacturing, with limitations in fluid flow and admixture, which delays test results and diverts resources, especially in portable molecular diagnostic systems.
Innovation Solution
A disposable cartridge with a filtration column assembly and flow control system that includes a tubular column, column matrix material, and a cap to direct filtered samples, along with a rotor and syringe barrel with compliant over-mold valves to prevent cross-contamination and ensure reliable fluid handling, facilitating hands-off operation and cost-effective manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sample preparation methods are used, then trained personnel can perform the tests, but the process is prone to cross-contamination and requires significant skilled resources
Solution Approach 1:
The system divides the sample preparation process into discrete, pre-configured modules within the rotor (separation chamber, reaction chambers, filtration columns). Each module is physically isolated and designed for single-use, eliminating cross-contamination between samples while requiring minimal operator skill to operate the automated system.
Solution Approach 2:
The disposable rotor is pre-configured with all necessary reagents, filtration columns, and separation mechanisms. The system performs sample processing automatically through automated fluid injection and rotor rotation, eliminating the need for skilled manual manipulation while maintaining high reliability through designed-in contamination barriers.
2Productivity
If manual sample preparation is performed, then flexibility in handling is maintained, but test results are delayed and skilled resources are diverted
Solution Approach 1:
The rotor is pre-loaded with reagents, filtration columns, and reaction chambers before use. Sample processing steps are pre-programmed into the automated system, allowing immediate processing upon sample insertion without manual preparation steps, thereby accelerating test results while maintaining full automation.
Solution Approach 2:
The automated system enables continuous processing of multiple samples through the rotor's sequential chamber design. While one sample is being processed, the system can prepare or load the next sample, eliminating idle time and maximizing productivity through uninterrupted automated operation.
3Manufacturing precision
If complex flow control mechanisms are used, then fluid handling precision is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The system uses disposable rotors with integrated, simple flow control features rather than complex reusable valve mechanisms. Each rotor is designed for single-use with built-in flow direction through its physical architecture, reducing manufacturing complexity while maintaining adequate fluid handling precision for the application.
Solution Approach 2:
The patent employs a compliant over-mold valve as an intermediary element between the syringe barrel and rotor ports. This simple elastic component provides sufficient flow control through pressure-responsive opening and closing, eliminating the need for complex mechanical or electronic valve systems while maintaining reliable fluid handling.
4Quantity of substance
If multiple assay chambers are used, then testing capacity is increased, but cross-contamination risk between chambers increases
Solution Approach 1:
The rotor is divided into multiple independently sealed reaction chambers, each dedicated to a specific assay. Physical separation walls and individual port configurations prevent fluid exchange between chambers, allowing parallel processing of multiple assays while maintaining complete isolation to prevent cross-contamination.
Solution Approach 2:
The system extracts and isolates each assay into its own dedicated chamber with separate reagent loading and waste collection pathways. This physical separation removes the possibility of cross-contamination between chambers while maintaining the capacity to perform multiple assays simultaneously through the multi-chamber rotor design.
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 reliable, repeatable, and cost-effective RNA polymerase-DNA analysis with minimally trained personnel, reducing the risk of cross-contamination and improving fluid flow, thus accelerating diagnostic processes and reducing resource diversion in clinical settings.
Implementation Method 1
a column matrix material configured to filter a fluid sample
Implementation Method 2
a cap configured to be inserted into an end of the tubular column and define a passageway to direct the sample fluid from the second end of the tubular column into a collection cavity
Implementation Method 3
a syringe plunger injects and withdraws sample fluids into and out of the disposable cartridge
Implementation Method 4
The assay system drives a rotor about a rotational axis
Data Source
AI summary
A disposable cartridge for mitigating cross-contamination of fluid sample reagents. The disposable cartridge includes a cartridge body defining a syringe barrel having an barrel port operative to inject and withdraw assay fluids in response to the displacement of a syringe plunger. Furthermore, the disposable cartridge includes a rotor defining a plurality of assay chambers in fluid communication with the barrel port through one of a plurality of rotor ports disposed about the periphery of the rotor. Finally, the disposable cartridge includes a flow control system between the barrel and rotor ports which prevents cross-contamination of fluid sample reagents from one assay chamber to another assay chamber.