Hydrogel Membrane Coatings for Analyte Sensor Signal Stability

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Solution Overview

Problem

Existing analyte monitoring systems, particularly those for continuous in vivo glucose monitoring, face challenges in optimizing signal response and stability due to Early Signal Attenuation (ESA) effects and night-time drop-outs, which affect the accuracy and reliability of glucose level measurements.

Innovation Solution

Incorporating a hydrogel membrane with a crosslinker, such as polyethylene glycol (PEG) epoxide or PEG acrylate, proximate to the working electrode of in vivo and/or in vitro analyte sensors to enhance signal response and stability, reducing ESA effects and night-time drop-outs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional membrane coatings are used in analyte sensors, then the device structure remains simple, but signal response and stability deteriorate due to Early Signal Attenuation effects and night-time drop-outs

Engineering Contradiction:
Improvesignal stabilityVSAvoidmembrane structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs composite hydrogel membranes incorporating multiple components including crosslinkers (PEG epoxide or PEG acrylate), swelling modulators, and analyte sensing materials. This composite structure resolves the contradiction by providing enhanced signal stability and reduced ESA effects through the synergistic interaction of membrane components, while maintaining a manageable device structure through integrated membrane formulation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies membrane parameters by adjusting crosslinker concentration, swelling modulator content, and hydrogel composition to optimize signal response. By changing these physical and chemical parameters of the membrane material, the invention achieves improved signal stability and reduced night-time drop-outs without fundamentally altering the sensor device architecture.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If hydrogel membranes with crosslinkers are incorporated to improve signal response, then measurement accuracy improves, but manufacturing complexity increases

Engineering Contradiction:
Improveglucose level accuracyVSAvoidmembrane fabrication
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent incorporates crosslinkers and swelling modulators into the hydrogel membrane formulation during the manufacturing process, preparing the membrane with pre-established crosslinking capabilities. This preliminary action ensures that the membrane achieves optimal signal response and measurement accuracy upon deployment, while the crosslinking process is integrated into standard manufacturing procedures to minimize fabrication complexity.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the membrane composition is optimized for signal response, then reliability improves, but the complexity of membrane formulation increases

Engineering Contradiction:
Improvecontinuous monitoring stabilityVSAvoidmembrane formulation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent optimizes the local composition of the hydrogel membrane by strategically distributing crosslinkers, swelling modulators, and sensing materials within the membrane matrix. This local quality approach ensures that critical regions of the membrane have the appropriate composition for high reliability and stable continuous monitoring, while the overall membrane formulation remains systematic and manufacturable.

Inventive Principle:
Principle #3Local quality

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 use of hydrogel membranes with crosslinkers improves the stability and response of analyte sensors, significantly reducing or eliminating ESA and night-time drop-outs, leading to more accurate and reliable continuous glucose monitoring.

Implementation Method 1

a coating including a hydrogel, a crosslinker, and a swelling modulator

Methodology Applied
Scientific EffectSwelling: Hydrogel

Implementation Method 2

a coating including a hydrogel, a crosslinker, and a swelling modulator

Methodology Applied
Scientific EffectCrosslinking: Chemical Bonding

Data Source

PatentUS9668685B2Analyte sensors comprising hydrogel membranes
Publication Date: 2017.06.06 ABBOTT DIABETES CARE INC
  • US9668685B2 patent drawing
  • US9668685B2 patent drawing
  • US9668685B2 patent drawing

AI summary

Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved signal response and stability by inclusion of a coating including a hydrogel, a crosslinker, and a swelling modulator, where the coating is disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.