Glucose-Responsive Microneedle Patch for Diabetes

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Solution Overview

Problem

Current methods for treating type 1 diabetes, such as traditional insulin injection and pancreatic β-cell transplantation, face challenges including inadequate glycemic control, complications from insulin overuse, and the need for surgical procedures, along with issues like biocompatibility problems and immune system reactions.

Innovation Solution

A microneedle patch system integrated with pancreatic β-cells and a glucose signal amplifier, which uses crosslinked hyaluronic acid and self-assembled polymeric nanosized vesicles to amplify glucose signals, allowing for minimally invasive, glucose-responsive insulin delivery without surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional insulin injection is used, then insulin delivery is achieved, but glycemic control is inadequate and hypoglycemia occurs

Engineering Contradiction:
Improveglycemic controlVSAvoidhypoglycemia
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a feedback mechanism where glucose sensor microneedles continuously monitor interstitial fluid glucose levels and transmit this information to a control system. The control system processes the glucose data and automatically adjusts insulin delivery through actuator microneedles, creating a closed-loop system that responds dynamically to changing glucose levels. This feedback control eliminates the need for manual dosing decisions and prevents hypoglycemia by only delivering insulin when glucose levels are elevated.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The artificial pancreas system operates autonomously without requiring user intervention for insulin dosing decisions. The system self-regulates by continuously sensing glucose levels, processing this information through a control algorithm, and automatically actuating insulin delivery. The microneedle array self-manages the entire therapeutic process from monitoring to treatment, reducing the burden on patients and eliminating dosing errors.

Inventive Principle:
Principle #25Self-service

2Reliability

If pancreatic β-cell transplantation is used, then insulin production is restored, but surgical procedures and immune suppression are required

Engineering Contradiction:
Improveinsulin productionVSAvoidsurgical procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the biological mechanical system of transplanted pancreatic cells with an engineered artificial system consisting of electronic sensors, microfluidic channels, and actuated microneedles. Instead of relying on living cell transplantation that requires surgical implantation and immunosuppression, the system uses glucose-sensing microneedles that electrically or optically detect glucose levels and trigger insulin delivery through actuator microneedles, eliminating the need for surgery and immune suppression therapy.

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

Solution Approach 2:

The system transforms the biological parameter-based insulin secretion mechanism into an engineered control system that uses electrical or optical signals for detection and mechanical actuation for delivery. The glucose sensor microneedles convert chemical glucose concentration into electrical or optical signals that can be processed by electronic control circuits, which then actuate the insulin-delivery microneedles through electrical or magnetic fields, replacing biological parameters with engineered signal transduction.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If cell capsule implantation is used, then cells are protected from immune system, but biocompatibility problems and fibrosis occur

Engineering Contradiction:
Improveimmune system recognitionVSAvoidbiocompatibility
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent uses microneedles as intermediary structures that bridge the external environment and the insulin delivery function without requiring permanent implantation. The microneedles penetrate the skin barrier temporarily to deliver insulin directly into the subcutaneous space, then dissolve or are removed, avoiding long-term foreign body presence. This intermediary approach protects the immune system from continuous exposure to foreign materials while maintaining delivery efficacy.

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 system effectively regulates blood glucose levels by promoting insulin secretion in response to hyperglycemic states, maintaining reduced glucose levels for extended periods and avoiding hypoglycemia, thus providing a non-invasive and biocompatible treatment for type 1 diabetes.

Implementation Method 1

The microneedle patch comprises crosslinked hyaluronic acid and self-assembled polymeric nanosized vesicles containing glucose oxidase, alpha-amylase and glucoamylase

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 2

glucose signal amplifier, which uses crosslinked hyaluronic acid and self-assembled polymeric nanosized vesicles to amplify glucose signals

Methodology Applied
Scientific EffectOxygen consumption: Oxidation

Implementation Method 3

The hypoxic signal triggers the disassembly of the polymeric nanosized vesicles and release of insulin through the microneedle patch

Methodology Applied
Scientific EffectHypoxia-responsive disassembly:

Implementation Method 4

A microneedle patch system integrated with pancreatic β-cells and a glucose signal amplifier, which uses crosslinked hyaluronic acid and self-assembled polymeric nanosized vesicles to amplify glucose signals, allowing for minimally invasive, glucose-responsive insulin delivery without surgery

Methodology Applied
Scientific EffectTransdermal delivery: Diffusion

Data Source

PatentEP3416621B1Physiologically responsive microneedle delivery systems
Publication Date: 2023.12.20 NORTH CAROLINA STATE UNIV
  • EP3416621B1 patent drawingFigure 1A~1B
  • EP3416621B1 patent drawingFigure 2A~2B
  • EP3416621B1 patent drawingFigure 2C~2D

AI summary

Disclosed herein are microneedle devices, kits comprising the microneedle devices, and methods of using the microneedle devices. Specifically, disclosed is a device for transport of a material across a biological barrier of a subject comprising: a plurality of microneedles each having a base end and a tip, with at least one pathway disposed at or between the base end and the tip; a substrate to which the base ends of the microneedles are attached or integrated; and at least one reservoir which is in connection with the base ends of the microneedles array, wherein the reservoir comprises an agent delivery system, wherein the agent delivery system comprises an agent to be transported across the biological barrier, or a means for producing an agent to be transported across the biological barrier, and a means for detecting a physiological signal from the recipient.