Metabolic Sensor Membrane Layers for Ethylene Oxide Sterilization
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Solution Overview
Problem
Conventional continuous glucose monitoring (CGM) systems face challenges in efficiently and cost-effectively sterilizing both the sensor/working wire and the processor/electronics components due to the damaging effects of electron beam and ethylene oxide sterilization processes, leading to reduced sensitivity and stability of the glucose sensor.
Innovation Solution
A continuous metabolic monitor is designed with a working wire having specially formulated membrane layers that resist the negative effects of gas sterilization, allowing for safe sterilization using ethylene oxide, which maintains or improves sensitivity and stability, enabling a single non-sterile container sterilization process for both the sensor and electronics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electron beam sterilization is used on the CGM system, then sterilization is achieved, but the sensor sensitivity and stability are reduced
Solution Approach 1:
The CGM system is divided into two separate components: a sterile sensor/working wire and a non-sterile processor/electronics. The sensor can be sterilized independently using electron beam sterilization to achieve sterilization effectiveness, while the electronics remain separate and are not exposed to the sterilization process, thus preserving sensor sensitivity and stability.
Solution Approach 2:
The electronics are extracted or removed from the sterilization process. The sensor is sterilized separately, and then the non-sterile electronics are connected to the sterile sensor after sterilization. This extraction allows the sensor to receive the full benefit of electron beam sterilization without the electronics being damaged, and the sensor's sensitivity and stability are maintained.
2Reliability
If ethylene oxide sterilization is used on the CGM system, then sterilization is achieved, but the sensor stability is reduced
Solution Approach 1:
The system is segmented into a sensor portion and an electronics portion. The sensor can be sterilized using ethylene oxide gas sterilization to achieve sterilization effectiveness, while the electronics are kept separate and not exposed to the sterilization process, thus preserving sensor stability.
Solution Approach 2:
The electronics are taken out or removed from the sterilization process. The sensor is sterilized separately using ethylene oxide, and then the non-sterile electronics are connected to the sterile sensor after sterilization. This extraction allows the sensor to receive the full benefit of ethylene oxide sterilization without the electronics being damaged, and the sensor's stability is maintained.
3Reliability
If separate sterilization processes are used for sensor and electronics, then component integrity is maintained, but manufacturing complexity increases
Solution Approach 1:
The manufacturing process is segmented into separate sterilization steps for the sensor and electronics. The sensor is sterilized first, then the electronics are connected after sterilization. This segmentation maintains component integrity by preventing damage to either component, and the separate processes are manageable and well-defined.
Solution Approach 2:
The sensor is sterilized in advance before the electronics are connected. This preliminary sterilization action ensures the sensor is sterile and ready for assembly, and the electronics are connected after sterilization to avoid exposure to sterilization processes. This sequencing simplifies the overall manufacturing process by establishing a clear, logical order of operations.
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 enables efficient and cost-effective sterilization of the CGM system, improving sensor stability and sensitivity, allowing for a lower-cost, more reliable continuous glucose monitoring system with enhanced performance characteristics.
Implementation Method 1
Electrochemical glucose sensors operate by using electrodes which typically detect an amperometric signal caused by oxidation of enzymes during conversion of glucose to gluconolactone
Implementation Method 2
a glucose limiting layer on the enzyme layer
Data Source
AI summary
A method of manufacturing a metabolic sensor includes assembling a working wire for a metabolic sensor and exposing the interference layer to an oxidizing agent. The exposing is performed prior to sterilizing the working wire. The assembling comprises forming an interference layer on a substrate, the substrate having an electrically conductive surface; forming an enzyme layer on the interference layer, and forming a glucose limiting layer on the enzyme layer.