Thermally Stable Glucose Limiting Membrane for Analyte Sensors

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Solution Overview

Problem

Existing glucose sensors face challenges in maintaining accuracy due to low oxygen concentrations in vivo, leading to oxygen deficit issues that compromise sensor readings, and conventional polymeric membranes degrade under high temperature and humidity conditions.

Innovation Solution

Development of polymeric reaction mixtures with limited catalyst amounts, incorporating diisocyanate, hydrophilic polymers, and siloxanes, along with polycarbonate diols, to form analyte modulating membranes that enhance thermal and hydrolytic stability, and improve oxygen and glucose permeability ratios.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If conventional polymeric membranes are used to control oxygen and glucose permeability, then oxygen permeability is improved, but thermal and hydrolytic stability deteriorates under high temperature and humidity conditions

Engineering Contradiction:
Improveoxygen permeabilityVSAvoidthermal and hydrolytic stability
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent employs a composite polymeric membrane system combining polyurea and polysiloxane components. The polyurea matrix provides structural stability and hydrolytic resistance, while the polysiloxane phase delivers high oxygen permeability. This composite architecture resolves the contradiction by distributing functional requirements across different material phases, allowing simultaneous achievement of oxygen permeability and thermal/hydrolytic stability that neither component could provide alone.

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If polymeric membranes with hydrophilic and hydrophobic regions are used to control permeability, then oxygen permeability is improved, but degradation occurs over time under high temperature and humidity conditions

Engineering Contradiction:
Improveoxygen permeabilityVSAvoidlong term stability
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent implements local quality differentiation within the polymeric membrane structure, creating distinct hydrophilic and hydrophobic regions with specific functional assignments. The hydrophobic polysiloxane domains provide oxygen permeability pathways, while the hydrophilic polyurea regions maintain structural integrity and resist hydrolytic degradation. This spatial differentiation of material properties allows the membrane to simultaneously achieve high oxygen permeability and long-term stability under harsh conditions.

Inventive Principle:
Principle #3Local quality

3Measurement precision

If glucose oxidase is used to catalyze glucose reaction, then glucose detection accuracy is improved, but sensor performance becomes compromised by low oxygen concentration in vivo

Engineering Contradiction:
Improveglucose detection accuracyVSAvoidsensor accuracy under low oxygen conditions
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent introduces a specially designed polymeric membrane as an intermediary layer between the biological sample and the glucose oxidase enzyme. This membrane acts as a selective mediator that regulates the transport of both oxygen and glucose to the enzyme active sites. By controlling the permeability ratios, the membrane ensures that oxygen is delivered in sufficient quantities to match glucose consumption rates, thereby maintaining stoichiometric balance and ensuring that sensor output reflects glucose concentration rather than oxygen availability.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 resulting sensors exhibit enhanced thermal stability and improved accuracy by maintaining glucose concentration readings independent of oxygen levels, with reduced degradation under harsh conditions, leading to longer sensor lifespan and improved biocompatibility.

Implementation Method 1

polymeric reaction mixtures with limited catalyst amounts, incorporating diisocyanate, hydrophilic polymers, and siloxanes, along with polycarbonate diols, to form analyte modulating membranes that enhance thermal and hydrolytic stability

Methodology Applied
Scientific EffectThermal stability enhancement:

Implementation Method 2

control oxygen and glucose permeability

Methodology Applied
Scientific EffectOxygen permeability: Permeation

Implementation Method 3

the O2 concentration must be in excess for all potential glucose concentrations

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

The glucose oxidase is used to catalyze the reaction between glucose and oxygen to yield gluconic acid and hydrogen peroxide

Methodology Applied
Scientific EffectCatalysis: Catalysis

Implementation Method 5

The H2O2 reacts electrochemically as shown in equation 2, and the current is measured by a potentiostat

Methodology Applied
Scientific EffectElectrochemical reaction:

Data Source

PatentUS12109023B2Thermally stable glucose limiting membrane for glucose sensors
Publication Date: 2024.10.08 MEDTRONIC MINIMED INC
  • US12109023B2 patent drawing
  • US12109023B2 patent drawing
  • US12109023B2 patent drawing

AI summary

Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor comprising an analyte modulating membrane formed from a polymeric reaction mixture formed to include limiting amounts of catalyst and/or polycarbonate compounds so as to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.