Biosensor Calibration via Sample Chamber Volume Alteration
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Solution Overview
Problem
Current biosensors require manual calibration or automatic calibration codes for accurate analyte detection, leading to variability in results due to differences in sensor lots, which can result in clinically inaccurate readings if not compensated for.
Innovation Solution
The sensors are pre-calibrated during manufacturing by physically altering the sample chamber volume or electrode area to achieve a standardized calibration, eliminating the need for user-input calibration codes and ensuring consistent, clinically accurate readings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If calibration codes are manually entered or automatically read for each sensor, then sensor calibration can be adjusted, but measurement precision deteriorates due to variability in results from different sensor lots
Solution Approach 1:
The patent applies preliminary action by performing calibration adjustment during the manufacturing process before the sensor reaches the user. Sensors are physically altered (e.g., by removing material from the electrode or sample chamber) during manufacturing to achieve a predetermined calibration, eliminating the need for post-manufacturing calibration codes and ensuring consistent, accurate measurements across all sensors in a lot.
2Measurement precision
If physically altering sample chamber volume or electrode area during manufacturing, then measurement precision improves through standardized calibration, but manufacturing complexity increases
Solution Approach 1:
The patent applies parameter changes by physically modifying the sample chamber volume or electrode area during manufacturing to achieve a predetermined calibration. These physical alterations (such as removing material) change the sensor's physical parameters to standardize its response characteristics, ensuring consistent and accurate analyte measurements while maintaining a relatively simple manufacturing process.
3Ease of operation
If calibration codes are eliminated through standardized manufacturing calibration, then ease of operation improves by removing user calibration requirements, but device complexity increases due to additional manufacturing steps
Solution Approach 1:
The patent applies self-service by enabling the sensor to be self-calibrated through its physical design and manufacturing process. The sensor automatically provides accurate measurements without requiring user intervention for calibration, as the calibration is built into the sensor itself during manufacturing. This eliminates the need for users to enter calibration codes or perform calibration procedures.
4Ease of operation
If multiple calibration-adjusted sensors are intermingled without calibration codes, then ease of operation improves, but manufacturing precision requirements increase to ensure uniform calibration
Solution Approach 1:
The patent applies preliminary action by performing calibration adjustment during the manufacturing process before sensors are packaged and made available to users. By standardizing the calibration process during manufacturing (e.g., through controlled material removal), the patent ensures uniform calibration across all sensors in a lot, allowing them to be intermingled and used without individual calibration codes while maintaining manufacturing precision.
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 approach ensures that all sensors provide consistent, clinically accurate analyte level readings without the need for user calibration, reducing variability and enhancing reliability in biosensor technology.
Implementation Method 1
The sensors include at least a working electrode and a counter electrode, which may be on the same substrate (e.g., co-planar) or may be on different substrates (e.g., facing). The sensors also include a sample chamber to hold the sample in electrolytic contact with the working electrode.
Implementation Method 2
A sensor of the invention may utilize a non-leachable or diffusible electron transfer agent and/or a redox mediator.
Data Source
AI summary
A sensor, and methods of making, for determining the concentration of an analyte, such as glucose, in a biological fluid such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and may include an insertion monitoring trace to determine correct positioning of the sensor in a connector. The sensor is calibration-adjusted, eliminating the need for a user to enter a calibration code or for the meter to read a calibration code.