Biosensor Contamination Detection via Preliminary Voltage Testing

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Solution Overview

Problem

Biosensors used in analyte measurement systems, such as disposable test strips, can become contaminated or damaged during storage, leading to erroneous analyte concentration measurements, which may result in incorrect medication dosing with potentially catastrophic consequences.

Innovation Solution

A method is developed to determine contamination of biosensors by applying predetermined voltages between electrodes for specific time intervals, measuring current values, and calculating reference values to assess contamination, thereby suppressing erroneous analyte readings if contamination is detected.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If biosensors are stored for self-administered blood tests, then they are readily available for use, but they may become contaminated or damaged leading to erroneous measurements

Engineering Contradiction:
Improveavailability for self-administered testingVSAvoidmeasurement accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system performs preliminary contamination detection by applying a predetermined voltage to the biosensor electrodes before the actual analyte measurement and compares the resulting current to reference values. This preliminary action identifies contaminated biosensors before they are used for critical measurements, preventing erroneous results while maintaining ease of use.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides feedback to the user about the contamination status of the biosensor. By comparing measured current values against reference values stored in memory, the system determines whether the biosensor is contaminated and communicates this status, allowing users to replace contaminated biosensors and avoid incorrect medication dosing decisions.

Inventive Principle:
Principle #23Feedback

2Measurement precision

If contamination detection methods are implemented, then measurement accuracy is improved, but device complexity increases

Engineering Contradiction:
Improvecontamination detection accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The contamination detection functionality is merged with the existing analyte measurement system. The same electrodes, voltage source, and processing unit used for analyte measurement are utilized for contamination detection, eliminating the need for separate detection hardware and minimizing additional device complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The biosensor electrodes serve multiple functions: they are used both for contamination detection (by applying predetermined voltage and measuring current) and for actual analyte measurement. This multi-functionality reduces the need for additional components and keeps the system relatively simple while enabling accurate contamination detection.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 allows for simultaneous analyte measurement and contamination determination, ensuring accurate results by preventing the reporting of higher-than-expected analyte concentrations and reducing the risk of incorrect medication administration.

Implementation Method 1

The analyte is allowed to react with a redox reagent to form an oxidizable (or reducible) substance in an amount corresponding to the analyte concentration. The quantity of the oxidizable (or reducible) substance present is then estimated electrochemically

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 2

A predetermined voltage is applied between the spaced electrodes for a predetermined time interval, and current values are measured. Whether the biosensor is contaminated is determined based on the measured current values

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS11604158B2Contamination determination of biosensors used in analyte measurement systems
Publication Date: 2023.03.14 LIFESCAN ENTERPRISES LLC
  • US11604158B2 patent drawing
  • US11604158B2 patent drawing
  • US11604158B2 patent drawing

AI summary

A method for determining contamination of a biosensor in which the biosensor is loaded into a test meter and a sample is then applied. First and second predetermined test voltages are applied between spaced electrodes of the biosensor for respective first and second predetermined time intervals. First and second current values are measured during the respective first and second predetermined time intervals. Reference values are determined based on the measured first and second current values. Based on one or more of the reference values, a determination of contamination is made. Reporting of the analyte concentration of the sample can be suppressed based on the determination.