Calibrator With Platinum Catalyst For Gamma Sterilization
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Solution Overview
Problem
Invasive or implantable medical sensors require sterile calibration and sterilization methods that avoid the limitations of existing techniques, such as steam, ethylene oxide, and gamma irradiation, which can degrade sensor components or affect calibration accuracy, especially when measuring water-soluble analytes.
Innovation Solution
A calibrator with a calibration chamber containing water or an aqueous solution and an H2O2-quenching material, such as a platinum coating on the lead screw, that allows gamma radiation sterilization while preventing hydrogen peroxide formation and contact with the sensor, enabling accurate calibration of sensors like glucose sensors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma irradiation is used to sterilize the calibrator, then sterile calibration is achieved, but hydrogen peroxide is formed in the calibration liquid which degrades sensor components and affects calibration accuracy
Solution Approach 1:
The patent converts the harmful effect of gamma radiation (which creates hydrogen peroxide) into a beneficial sterilization process by using a platinum catalyst that selectively decomposes hydrogen peroxide into water and oxygen. The platinum coating on the lead screw transforms the harmful radiation byproduct into a safe outcome, enabling sterile calibration without sensor degradation.
Solution Approach 2:
The platinum coating on the lead screw acts as an intermediary substance that mediates between the gamma radiation sterilization process and the calibration liquid. It catalyzes the decomposition of hydrogen peroxide formed during irradiation, preventing direct contact between the harmful peroxide and the sensor components while maintaining sterile conditions.
2Reliability
If steam sterilization is used, then effective sterilization is achieved, but sensor components with low melting point or labile chemical/biological components are degraded
Solution Approach 1:
The patent replaces the thermal sterilization method (steam at temperatures above 116°C) with a radiation-based sterilization method using gamma irradiation. This substitution eliminates the thermal stress that would degrade low-melting-point plastics and labile biological components while still achieving effective sterilization through the platinum-catalyzed decomposition of radiation-induced peroxide.
3Strength
If ethylene oxide sterilization is used, then sensor components are preserved, but water must be removed from hydrophilic materials and calibration vessels cannot be sterilized
Solution Approach 1:
The patent changes the sterilization parameter from chemical (ethylene oxide gas) to physical (gamma radiation with platinum catalysis). This allows water to remain in the calibration liquid and hydrophilic materials to maintain their moisture content, eliminating the need to remove water from sensor components while still achieving effective sterilization through radiation-induced peroxide decomposition.
4Measurement precision
If calibration is performed at the point of use, then sensor accuracy is maintained, but sterile integrity must be maintained during calibration which complicates the calibration process
Solution Approach 1:
The patent performs preliminary sterilization of the calibrator using gamma irradiation with platinum-catalyzed peroxide decomposition before the calibration process. This pre-sterilization ensures that the calibration chamber and liquid remain sterile during the calibration procedure, allowing accurate calibration at the point of use without compromising sterile integrity or requiring complex sterile maintenance procedures.
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 solution ensures sterile calibration and effective sterilization of sensors without degrading calibration solutions, maintaining sensor accuracy and extending shelf life by preventing hydrogen peroxide interference, thus addressing the limitations of existing methods.
Implementation Method 1
an H2O2-quenching material, exposed to the interior of the calibration chamber, for contacting the calibration liquid
Implementation Method 2
A calibrator with a calibration chamber containing water or an aqueous solution and an H2O2-quenching material, such as a platinum coating on the lead screw, that allows gamma radiation sterilization
Data Source
AI summary
A calibrator, for calibrating a sensor, has a calibration chamber for containing a calibration liquid. The liquid comprises water or an aqueous solution of an analyte to be sensed. A hydrogen peroxide-quenching material is provided exposed to the interior of the calibration chamber. The hydrogen peroxide-quenching material contacts the calibration liquid. After the calibration chamber containing the calibration liquid is sterilized by irradiation with gamma radiation, the hydrogen peroxide-quenching material decomposes any hydrogen peroxide formed in the calibration liquid to avoid adverse effects on a sensor placed in contact with the calibration liquid.