Lyophilized Reagent Microfluidics for Sensor Calibration
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Solution Overview
Problem
Current liquid reagents for sensor calibration and quality control have limited shelf life due to degradation and cross-reaction products, necessitating improved reagent embodiments and delivery systems for maintaining gas concentrations in sensors.
Innovation Solution
A microfluidics device containing lyophilized reagents, such as sodium bicarbonate, which are reconstituted in situ with an excipient to provide calibration and quality control solutions for monitoring blood gas, electrolyte, and metabolite instrumentation, maintaining a predetermined gas concentration and preventing exposure to humidity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid reagents are used for sensor calibration, then gas concentrations can be maintained, but shelf life is limited due to degradation and cross-reaction products
Solution Approach 1:
The patent changes the physical state of the reagent from liquid to lyophilized (dried) form, fundamentally altering the storage parameters. This allows the reagent to be stored in a stable, non-degradable state while maintaining the capability to deliver accurate gas concentrations when reconstituted, thereby extending shelf life without compromising calibration reliability
Solution Approach 2:
The patent utilizes phase transition between dried and reconstituted states. The lyophilized reagent is stored in a dry, stable phase that prevents degradation. When needed, it transitions to a liquid phase through reconstitution with excipient, enabling it to function as a calibration solution with predetermined gas concentrations, thus resolving the contradiction between stability during storage and functionality during use
2Reliability
If liquid reagents are stored in glass ampoules or laminate barrier pouches, then gas concentrations are maintained, but degradation products still form over time
Solution Approach 1:
The patent extracts the harmful element of time-dependent degradation by removing the reagent from its liquid state during storage. By taking out the water component through lyophilization, the reagent is placed in a state where chemical reactions and degradation pathways are effectively halted, eliminating the formation of degradation products while preserving gas concentration stability
Solution Approach 2:
The patent applies preliminary action by pre-drying the reagent in a controlled manner before storage. The lyophilization process is performed in advance to create a stable, degradation-free storage form. This preliminary removal of water prevents degradation from occurring during storage, while the reagent retains full functionality when reconstituted for calibration
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 device extends the shelf life of calibration solutions by maintaining reagents in a dry state until use, ensuring accurate gas concentrations and preventing degradation, thus enhancing the reliability of sensor performance.
Implementation Method 1
lyophilized reagent for reconstitution as calibration and/or quality control solutions
Implementation Method 2
a composition comprising a predetermined amount of at least one lyophilized reagent
Data Source
AI summary
Devices contain dried reagents that may be reconstituted and used in the calibration and quality control of sensors. Methods of producing and using the devices are also disclosed.