Resin Microneedle Allergy Diagnosis via Segmentation

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Solution Overview

Problem

Conventional allergy diagnosis methods, such as patch tests and skin prick tests, are time-consuming, inaccurate, and can cause pain and bleeding, while existing microneedle technologies face challenges with metal allergenicity, cost, and inefficiency in antigen delivery.

Innovation Solution

A microneedle device using non-metallic synthetic or natural resin materials with microneedles 50 µm to 500 µm deep and coated with allergens, allowing for quick and accurate percutaneous antigen delivery, reducing test duration and discomfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional patch test is used with strong barrier function of horny layer, then skin barrier protection is maintained, but test duration becomes long (48 hours) and accuracy of skin color change judgment is poor

Engineering Contradiction:
Improveskin barrier protectionVSAvoidtest duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The microneedle array divides the skin penetration function into multiple individual microneedles (50-500 µm length), each capable of independently penetrating the horny layer and delivering antigen to Langerhans cells in the dermis, thereby reducing the required contact time while maintaining barrier integrity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the physical parameter of antigen delivery by using microneedles of specific length (50-500 µm) that can penetrate the horny layer to reach the dermis, enabling faster antigen presentation to Langerhans cells compared to conventional patch tests, thus reducing test duration from 48 hours to approximately 20 minutes

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If conventional patch test uses macroscopic skin color change judgment, then simplicity of operation is maintained, but measurement precision of allergy degree is insufficient

Engineering Contradiction:
Improveoperation simplicityVSAvoidallergy degree determination accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention utilizes color change of the microneedle array or coating material as an indicator of antigen delivery and skin reaction, providing a more precise and objective measurement of allergy degree compared to conventional macroscopic skin color change judgment, while maintaining operational simplicity

Inventive Principle:
Principle #32Color changes

3Productivity

If iontophoresis or electroporation apparatus is used to increase antigen permeability, then antigen delivery efficiency is improved, but device complexity and skin irritation increase

Engineering Contradiction:
Improveantigen delivery efficiencyVSAvoidapparatus complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention extracts the essential function of iontophoresis and electroporation (enhancing antigen permeability) and implements it through simple microneedles (50-500 µm length) that physically penetrate the horny layer, eliminating the need for complex apparatus while maintaining high antigen delivery efficiency to Langerhans cells

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The microneedle array serves as a simple, disposable device that achieves effective antigen delivery without requiring complex, reusable apparatus, thereby reducing device complexity and minimizing skin irritation while maintaining high productivity in antigen delivery

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Speed

If injection needle is used for subcutaneous antigen administration, then antigen delivery speed is improved, but burden on subject increases due to multiple antibody examinations

Engineering Contradiction:
Improveantigen delivery speedVSAvoidsubject burden
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The microneedles deliver antigen locally to Langerhans cells in the dermis through controlled penetration (50-500 µm), enabling fast antigen delivery without requiring subcutaneous injection and subsequent multiple antibody examinations, thereby reducing subject burden while maintaining high delivery speed

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

Enables a clear and efficient allergy diagnosis in approximately 20 minutes with minimal pain and bleeding, using inexpensive non-metallic microneedles for effective antigen delivery through the skin.

Implementation Method 1

a plurality of microneedles (3) which are capable of piercing the skin

Methodology Applied
Scientific EffectMechanical penetration: Mechanical Force

Implementation Method 2

an allergen-holding means (4) which holds at least one allergen by using a coating carrier, wherein the coating (4) is applied to the microneedles (3)

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP2119469B1Microneedle device for diagnosis of allergy
Publication Date: 2014.05.14 HISAMITSU PHARM CO INC
  • EP2119469B1 patent drawingFigure 1(a)~1(b)
  • EP2119469B1 patent drawingFigure 2

AI summary

There is provided an inexpensive microneedle device for diagnosis of an allergy, enabling one to perform a clear skin test with simple operation for a short period of time in the diagnosis of allergies. The microneedle device (1) comprises: a microneedle substrate (2), microneedles (3) formed on the substrate at a density of 100 to 10000 needles per 1 cm2, being capable of piercing the skin 50 µm to 500 µm deep, and allergen-holding means (4) formed on the microneedles, holding at least one allergen. The microneedles (3) can be prepared by the use of a non-metallic synthetic or natural resin material.