Multi-Layer Skin-Piercing Device with Controlled Depth and Substance Delivery

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Solution Overview

Problem

Existing skin prick tests lack consistency and reliability due to variable administration of allergenic substance quantity, concentration, and depth of penetration, posing risks of undue pain and discomfort.

Innovation Solution

A skin penetration device with a multi-layer structure that includes a skin-piercing component, a protrusion layer, and a spacing layer to control the quantity, concentration, and depth of the allergenic substance, featuring a self-retracting piercing element for precise and controlled skin penetration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a needle or lancet is used to penetrate the skin manually, then the test can be administered quickly with minimal preparation, but the quantity of substance, depth and width of penetration vary considerably between tests

Engineering Contradiction:
Improvetest administration speedVSAvoidpenetration depth consistency
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The device segments the penetration function into a separate reusable skin-piercing component that can be precisely manufactured with controlled depth characteristics, while the main body contains the substance reservoir. This allows the penetration depth to be determined by the pre-manufactured component geometry rather than manual operation variability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the parameter of penetration depth from being operator-dependent to being device-determined through the specific design of the skin-piercing component. The component is manufactured with precise dimensional parameters that control penetration depth, ensuring consistency across all tests.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If multiple lancet tests are administered simultaneously using an array of needles, then efficiency is improved, but it is difficult to apply equal force to all needles and the amount of substance on each needle varies

Engineering Contradiction:
Improvemultiple tests per administrationVSAvoidsubstance quantity consistency
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The skin-piercing components are nested within individual protrusions of the second layer, with each component contained within its own encapsulated space. This nesting structure ensures that each component receives a controlled amount of substance from its corresponding protrusion, preventing variation in substance quantity across multiple test sites.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The substance is pre-loaded into the protrusions during device manufacturing, before use. This preliminary action ensures that each skin-piercing component has the correct amount of substance already in place, eliminating the need for manual substance application and ensuring consistency across all test sites.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the skin is penetrated deeper to ensure adequate substance delivery, then the test reliability improves, but pain and discomfort to the recipient increase

Engineering Contradiction:
Improvesubstance delivery effectivenessVSAvoidpain and discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention changes the penetration depth parameter from being variable and potentially excessive to being precisely controlled at the optimal level. The skin-piercing component is designed with specific dimensional parameters that achieve adequate substance delivery while minimizing penetration depth to reduce pain and discomfort.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4346559B1Skin penetration device and skin-piercing component
Publication Date: 2025.08.06 MEDIDESIGN LTD
  • EP4346559B1 patent drawingFigure 1~3
  • EP4346559B1 patent drawingFigure 4
  • EP4346559B1 patent drawingFigure 5

AI summary

A skin penetration device (2, 102, 202, 302) for administering a test substance (10). The skin penetration device has a first layer (4, 104, 204, 304), a second layer (6, 106, 206, 306), and a third layer (12, 212, 312). It may also have a fourth layer (16, 116, 216). The second layer has a protrusion (8, 108, 208, 308) providing a hollow space for containing the substance to be administered. The skin penetration device further has a skin-piercing component (18, 118, 218, 318) that can release the substance and rupture the skin when pressed towards the skin in use. The skin-piercing component has a rest configuration and is configured to be biased towards the rest configuration such that it may be deformed but returns to the rest configuration when the deforming force is removed.