Diagnostic Strip Conductive Layers Auto-Calibration
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Solution Overview
Problem
Existing diagnostic test strips for measuring analyte concentrations in bodily fluids face issues with inaccurate calibration due to human error and are prone to abrasion, leading to erroneous results, and require costly bar-code imprinting and complex meter integration.
Innovation Solution
The development of diagnostic test strips with embedded lot-specific codes and abrasion-resistant electrical contacts, featuring multiple layers of conductive materials and insulating layers to prevent scratching, allowing for auto-calibration and reliable operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual input or connection of lot code is required, then calibration data can be provided to the meter, but human error increases leading to inaccurate measurements
Solution Approach 1:
The test strip automatically provides lot code information to the meter through embedded conductive layers that electrically communicate the code without requiring user intervention. The strip itself serves the function of transmitting its identification data, eliminating the need for manual input and associated human errors.
Solution Approach 2:
The patent replaces manual mechanical input methods (typing, button pressing) with an electrical field-based communication system. Conductive layers on the test strip create electrical signals that the meter automatically detects and reads, substituting mechanical human interaction with an automated electrical field communication mechanism.
2Loss of information
If bar-code imprinting is used on individual strips, then lot code information can be provided, but manufacturing cost and device complexity increase
Solution Approach 1:
The patent replaces optical bar-code reading systems with an electrical field-based communication system. Instead of using optical sensors and complex image processing to read bar codes, the system uses simple electrical contacts and conductive layer detection to automatically identify the lot code, significantly reducing device complexity.
Solution Approach 2:
The patent extracts the lot code information function from separate bar-code components and integrates it directly into the test strip's conductive structure. The identification function is embedded within the electrical contact layers themselves, eliminating the need for separate bar-code printing and reading subsystems.
3Reliability
If rigid conductive contacts are used in the meter, then electrical connection can be established, but abrasion of test strip surface occurs leading to erroneous results
Solution Approach 1:
The patent uses composite conductive layer structures on the test strip, combining multiple materials with different properties. The conductive layers are designed with specific material compositions that provide both electrical conductivity and enhanced mechanical durability to resist abrasion from meter contacts, preventing material transfer and electrical connection failures.
4Adaptability or versatility
If manual calibration input is required, then flexibility in calibration data entry is provided, but time consumption and error risk increase
Solution Approach 1:
The test strip automatically performs the calibration identification function by electrically transmitting its lot code to the meter. The strip serves itself by providing its own identification information without requiring user intervention, eliminating the time-consuming manual data entry process while maintaining system flexibility through automated code recognition.
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 provides accurate and reliable analyte concentration measurements by eliminating human error in calibration and reducing the risk of abrasion-related errors, while also enabling cost-effective and efficient production and packaging of test strips.
Implementation Method 1
The conductive layers may be formed of any suitable conductive material, including, but not limited to, metal, conductive ink, or conductive paste
Implementation Method 2
A second conductive layer may then be applied over the first conductive layer. In some embodiments, an insulating layer may be provided between the first and second conductive layers
Implementation Method 3
When the user applies a blood sample to the sample chamber, the reagents react with the glucose, and the meter applies a voltage to the electrodes to cause a redox reaction
Data Source
AI summary
A diagnostic test strip is provided. The test strip (10) comprises at least one electrically insulating substrate material (16) and a plurality of electrical strip contacts (46-52) disposed on the least one insulating substrate layer (16). The at least one electrical strip contact includes a first conductive layer disposed on the substrate, and a second conductive layer disposed on top of the first conductive layer.