Planar Flexible Glucose Sensor Layout for Continuous Low-Pain Sensing

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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

VSEngineering Contradiction Analysis

1Reliability

If subcutaneous implantation is used for continuous monitoring, then continuous glucose measurement is achieved, but insertion pain and infection risk increase

Engineering Contradiction:
Improvecontinuous monitoring capabilityVSAvoidinsertion pain and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical insertion process of traditional subcutaneous sensors with a microneedle array system that utilizes minimally invasive percutaneous insertion. The microneedles are designed to penetrate the skin barrier with reduced pain and trauma, substituting the harmful mechanical insertion with a gentler alternative that achieves the same continuous monitoring function.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The sensor employs a flexible substrate that allows the microneedle array to conform to the skin surface and adapt during insertion. This flexibility reduces mechanical stress and pain during insertion while maintaining the integrity of the sensor components, thereby reducing insertion pain without compromising continuous monitoring capability.

Inventive Principle:
Principle #30Flexible shells and thin films

2Measurement precision

If traditional meter and test strip systems are used, then blood glucose measurement is achieved, but frequent painful finger-sticks are required

Engineering Contradiction:
Improveblood glucose measurementVSAvoidrepeated insertion pain
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The microneedle array is pre-loaded with glucose sensing reagents and enzymes before insertion. Once inserted, the sensor continuously measures glucose in the interstitial fluid without requiring repeated blood draws. This preliminary preparation eliminates the need for frequent finger-sticks while maintaining measurement precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sensor provides continuous glucose monitoring by maintaining a persistent connection to the interstitial fluid through the microneedle array. This continuous action replaces the discrete, repeated finger-stick measurements with an uninterrupted measurement stream, eliminating repeated pain while sustaining measurement accuracy.

Inventive Principle:
Principle #20Continuity of useful action

3Ease of manufacture

If roll-to-roll fabrication is used, then production cost is reduced, but manufacturing precision may be compromised

Engineering Contradiction:
Improveproduction costVSAvoidsensor fabrication accuracy
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent employs roll-to-roll fabrication with precisely controlled deposition parameters for forming the microneedle arrays, electrode patterns, and encapsulation layers. By optimizing parameters such as deposition thickness, needle spacing, and material composition during the rolling process, high manufacturing precision is achieved while maintaining the cost advantages of continuous production.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The fabrication process applies different material properties and structural characteristics to specific regions of the sensor. The microneedle tips, for example, are designed with specific geometries and material compositions optimized for painless insertion, while the substrate and encapsulation layers have different properties optimized for flexibility and protection. This localized optimization maintains high precision throughout the device despite mass production methods.

Inventive Principle:
Principle #3Local quality

4Duration of action of stationary object

If microneedle array with encapsulation is used, then sensor durability is improved, but device complexity increases

Engineering Contradiction:
Improvesensor lifespanVSAvoidsensor structure
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The patent integrates multiple functions into unified structures to manage complexity. The encapsulation layer simultaneously protects the microneedle array from mechanical damage, seals the sensing reagents from contamination, and provides a biocompatible interface with tissue. The flexible substrate combines structural support, electrical connectivity, and mechanical flexibility in a single component. This merging of functions extends sensor lifespan while controlling overall device complexity.

Inventive Principle:
Principle #5Merging (Combining)

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, along with longer sensor lifespan and lower production costs, enabling more effective glycemic control and increased adoption of continuous glucose monitoring.

Implementation Method 1

a layer of sputtered platinum on the polyester substrate

Methodology Applied
Scientific EffectSputtering: Sputtering

Implementation Method 2

a glucose oxidase layer

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

the glucose oxidase is used to catalyze the reaction between glucose and oxygen

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 4

silver/silver chloride ink

Methodology Applied
Scientific EffectRedox reactions: Redox Reactions

Data Source

PatentUS11512384B2Analyte sensors and methods for fabricating analyte sensors
Publication Date: 2022.11.29 MEDTRONIC MINIMED INC
  • US11512384B2 patent drawing
  • US11512384B2 patent drawing
  • US11512384B2 patent drawing

AI summary

Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a method for fabricating a planar flexible analyte sensor includes sputtering platinum onto a polyester base layer to form a layer of platinum. The method includes patterning the layer of platinum to form working electrodes and additional electrodes. Further, the method includes forming an insulating dielectric layer over the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes and portions of the additional electrodes. Also, the method includes partially singulating individual sensors from the base layer, wherein each individual sensor is connected to the base layer by a tab. The method further includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.