Roll-to-Roll Flexible Glucose Sensor Fabrication for Low-Cost CGM
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Solution Overview
Problem
Current glucose monitoring sensors are painful to insert, require frequent calibration with painful finger-sticks, and have limitations in long-term durability and cost-effective large-scale production, leading to suboptimal glycemic control for diabetic patients.
Innovation Solution
Development of a planar flexible analyte sensor with a platinum-sputtered layer on a polyester substrate, featuring an insulating dielectric layer, silver/silver chloride ink, and a glucose oxidase layer, fabricated using roll-to-roll processes to reduce production costs and enhance sensor accuracy and longevity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If subcutaneously implanted sensors are used for continuous glucose monitoring, then continuous measurement capability is improved, but insertion pain and requirement for health care professional assistance worsen
Solution Approach 1:
The sensor employs a flexible printed circuit board (FPC) substrate with thin-film electrodes and a soft elastomeric encapsulation layer, creating a flexible, thin-profile sensor that can be minimally invasively inserted and conforms to body contours, reducing insertion pain and discomfort while maintaining continuous monitoring capability
Solution Approach 2:
The patent replaces traditional mechanical needle insertion mechanisms with a flexible, minimally invasive insertion approach using a soft elastomeric body that can be inserted through a small puncture or adhesive application, eliminating the need for sharp needles and reducing insertion pain
2Measurement precision
If traditional meters and test strips are used for blood glucose monitoring, then measurement capability is provided, but frequent painful finger-sticks for calibration are required
Solution Approach 1:
The sensor performs self-calibration by utilizing the body's own glucose levels as the calibration standard, eliminating the need for external blood samples. The FPC-based sensor continuously measures interstitial fluid glucose and automatically adjusts its readings to match blood glucose levels without requiring user intervention or painful finger-sticks
Solution Approach 2:
The sensor is pre-calibrated during manufacturing using known glucose concentrations, and includes onboard algorithms that perform automatic calibration routines using the patient's own physiological data, eliminating the need for subsequent manual calibration with test strips
3Duration of action of moving object
If subcutaneously implanted sensors are used for continuous monitoring, then continuous glucose data is obtained, but sensor accuracy deteriorates over time requiring frequent recalibration
Solution Approach 1:
The FPC-based sensor incorporates feedback mechanisms where continuous glucose measurements are compared against reference values, and the sensor automatically adjusts its calibration factors in real-time. This closed-loop system maintains accuracy over extended periods by continuously adapting to changes in sensor performance and physiological conditions
Solution Approach 2:
The sensor dynamically adjusts measurement parameters such as calibration factors, sensitivity coefficients, and offset values based on continuous monitoring data and environmental conditions. This allows the sensor to compensate for drift and maintain accuracy throughout its operational lifetime without frequent manual recalibration
4Reliability
If conventional sensor fabrication methods are used, then sensor production is achieved, but production cost and complexity increase limiting large-scale manufacturing
Solution Approach 1:
The FPC substrate serves multiple functions simultaneously: it provides mechanical support, electrical connectivity through printed traces, signal routing, and structural framework for mounting sensors and electronics. This multi-functionality eliminates the need for separate components and assembly steps, reducing manufacturing complexity and cost while maintaining sensor reliability
Solution Approach 2:
The sensor utilizes flexible printed circuit board technology with thin-film deposited electrodes and encapsulation layers, enabling low-cost, high-volume manufacturing through roll-to-roll processing. This flexible thin-film approach replaces expensive rigid PCB fabrication and assembly processes, making large-scale production economically viable
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 improved accuracy and reduced pain during use, with potential for longer-term continuous glucose monitoring and lower production costs, enhancing glycemic control and patient safety.
Implementation Method 1
an enzyme layer, such as a glucose oxidase layer
Implementation Method 2
the glucose oxidase is used to catalyze the reaction between glucose and oxygen to yield gluconic acid and hydrogen peroxide (H2O2)
Implementation Method 3
a layer of sputtered platinum on a polyester substrate
Data Source
AI summary
Analyte sensors and methods for fabricating analyte sensors in a roll-to-roll process are provided. In an exemplary embodiment, a method includes providing a roll of a polyester substrate having a first side coated with a layer of platinum, wherein the platinum is in direct contact with the polyester substrate; patterning the layer of platinum to form electrodes; punching the polyester substrate to form ribbons, wherein each ribbon is connected to a remaining polyester substrate web by a tab, and wherein each sensor includes an electrode; after punching the polyester substrate to form ribbons, depositing an enzyme layer over the portions of the working electrodes and coating the working electrodes with a glucose limiting membrane; after depositing the enzyme layer over the portions of the working electrodes and coating the working electrodes with a glucose limiting membrane, singulating the individual sensors by completely separating each individual sensor from the polyester substrate.