Thermoresponsive Hydrogel Membrane for Implantable Sensor Self-Cleaning

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Solution Overview

Problem

Implantable medical devices, such as glucose sensors, face limitations due to biofouling, which reduces analyte diffusion and signal strength, leading to decreased sensitivity and lifespan, necessitating the development of self-cleaning membranes that can mitigate foreign body reactions and maintain sensitivity and efficacy over time.

Innovation Solution

A thermoresponsive hydrogel membrane comprising N-isopropylacrylamide, polysiloxane colloidal nanoparticles, and N-vinylpyrrolidone, which deswells and reswells in response to body temperature fluctuations, disrupting biofouling and maintaining analyte diffusion by changing its hydrophilicity and mechanical properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional implantable sensor is used, then initial sensitivity and analyte detection are achieved, but biofouling accumulates over time reducing sensitivity and lifespan

Engineering Contradiction:
Improvesensor sensitivityVSAvoiddevice lifespan
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The membrane is designed with thermoresponsive hydrogel that dynamically changes its swelling state in response to temperature fluctuations. The membrane swells at lower temperatures to facilitate analyte diffusion and deswells at higher temperatures to detach biofouling, creating a dynamic self-cleaning system that adapts to maintain sensor performance over time

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system utilizes periodic temperature fluctuations (body temperature variations throughout the day) to trigger periodic swelling and deswelling cycles of the membrane. These periodic changes in hydrophilicity and mesh size create mechanical stress that periodically detaches accumulated biofouling, preventing permanent signal degradation

Inventive Principle:
Principle #19Periodic action

2Reliability

If the membrane swells to enhance analyte diffusion, then sensor sensitivity improves, but biofouling accumulation increases

Engineering Contradiction:
Improveanalyte diffusionVSAvoidbiofouling accumulation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The membrane's physical parameters (swelling ratio, mesh size, hydrophilicity) are changed in response to temperature variations. At physiological temperatures, the membrane maintains a swollen state with increased mesh size for optimal analyte diffusion, while periodic temperature increases trigger parameter changes that reduce biofouling adhesion

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If external temperature regulation is applied to clean the membrane, then biofouling is removed, but device complexity and energy consumption increase

Engineering Contradiction:
Improvebiofouling removalVSAvoidtemperature regulation system
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The membrane autonomously responds to naturally occurring body temperature fluctuations to perform self-cleaning. The thermoresponsive hydrogel material inherently converts thermal energy into mechanical swelling/deswelling motion, eliminating the need for external heating elements, temperature sensors, or control systems

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces complex mechanical or electrical temperature regulation systems with a passive material-based solution. Instead of using motors, heaters, or sensors to control membrane swelling, the system relies on the intrinsic thermoresponsive properties of the hydrogel material to automatically respond to thermal stimuli

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

4Reliability

If the membrane swells to maintain hydrophilicity, then analyte diffusion is enhanced, but mechanical stability decreases

Engineering Contradiction:
ImprovehydrophilicityVSAvoidmembrane mechanical stability
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The membrane employs a composite structure combining thermoresponsive hydrogel with a supportive matrix or crosslinked network. This composite design allows the hydrogel component to provide hydrophilicity and swelling behavior while the matrix maintains mechanical integrity and prevents excessive deformation during temperature-induced volume changes

Inventive Principle:
Principle #40Composite materials

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 thermoresponsive hydrogel membrane effectively self-cleans by detaching biofouling products, enhancing glucose diffusion and sensor accuracy, and extending the lifespan of implantable medical devices without the need for external temperature regulation.

Implementation Method 1

the membrane comprises a thermoresponsive hydrogel comprising N-isopropylacrylamide, one or more polysiloxane colloidal nanoparticles, a comonomer of N-vinylpyrrolidone, and a volume phase transition temperature

Methodology Applied
Scientific EffectVolume phase transition: Phase Change

Implementation Method 2

temperature fluctuations within the target area that exceed the volume phase transition temperature induce deswelling in the membrane and temperature fluctuations within the target area that fall behind the volume phase transition temperature induce swelling in the membrane

Methodology Applied
Scientific EffectThermoresponsive behavior: Thermal Expansion

Implementation Method 3

disrupting biofouling and maintaining analyte diffusion by changing its hydrophilicity and mechanical properties

Methodology Applied
Scientific EffectHydrophilicity change: Hydrophobe

Implementation Method 4

enhancing glucose diffusion and sensor accuracy

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS11701455B2Self-cleaning membrane for medical devices
Publication Date: 2023.07.18 TEXAS A&M UNIVERSITY
  • US11701455B2 patent drawing
  • US11701455B2 patent drawing
  • US11701455B2 patent drawing

AI summary

The disclosure provides a method for cleaning an implanted medical device. In one embodiment, the method includes providing a medical device including a membrane; wherein the membrane comprises a thermoresponsive hydrogel including N-isopropylacrylamide (NIPAAm) or poly(N-isopropylacrylamide) (PNIPAAm), and a volume phase transition temperature (VPTT). The method also includes implanting the medical device into a target area; wherein the membrane temperature is maintained at substantially the same temperature as the target area; wherein temperature fluctuations within the target area that approach, meet and/or exceed the volume phase transition temperature induce deswelling or relative deswelling in the membrane and temperature fluctuations within the target area that are relatively lower and/or approach and/or fall below the volume phase transition temperature induce swelling or relative swelling in the membrane.