Micro-needle array sampling for consistent biological material collection

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Solution Overview

Problem

Current methods for sample collection, such as venepuncture and buccal swabs, are invasive, painful, and inconsistent, leading to discomfort and potential avoidance of medical care, while existing micro-needle technologies primarily focus on drug delivery and lack standardization for nucleic acid preservation.

Innovation Solution

A method utilizing an array of micro-needles on a flexible base plate to collect biological samples from the epidermis or dermis, with the ability to penetrate and adhere biological material, followed by transfer to a solid medium for stabilization and storage, utilizing micro-needles with varying lengths, shapes, and surface modifications for enhanced adherence and consistency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If venepuncture or finger prick is used for sample collection, then blood samples can be obtained for diagnostic purposes, but the subject experiences pain and discomfort leading to avoidance of medical care

Engineering Contradiction:
Improvesample collection reliabilityVSAvoidpain and discomfort to subject
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention divides the sampling function into multiple micro-needles arranged in an array on a flexible base plate. Each micro-needle penetrates the skin independently to collect cellular material, distributing the invasive action across many small points rather than a single large puncture, thereby reducing pain while maintaining sampling reliability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The micro-needles are designed with specific local properties: varying lengths (0.2-2mm), different geometries (conical, pyramidal, cylindrical tips), and surface modifications (roughened, barbed, coated) to optimize penetration and cellular material adherence at the skin interface, while the flexible base plate adapts to the skin surface geometry

Inventive Principle:
Principle #3Local quality

2Object-affected harmful factors

If buccal swabs are used for sample collection, then the procedure is less invasive, but the number of cells collected varies significantly depending on technique and donor factors

Engineering Contradiction:
Improveinvasiveness of procedureVSAvoidconsistency of sample collection
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention systematically varies key parameters of the micro-needles including length (0.2-2mm), diameter (50-500μm), tip geometry (conical, pyramidal, cylindrical), and surface properties (roughened, barbed, coated) to optimize both penetration depth and cellular material adherence, ensuring consistent sampling across different donors and operators

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The array of micro-needles creates multiple identical sampling points on the skin surface, ensuring that each location contributes equally to the total sample. This replicates the sampling function across many points rather than relying on a single variable swabbing action, thereby improving consistency

Inventive Principle:
Principle #26Copying

3Adaptability or versatility

If existing micro-needle devices are used for drug delivery, then transdermal delivery is achieved, but the devices lack standardization for nucleic acid preservation and sample collection

Engineering Contradiction:
Improvetransdermal delivery capabilityVSAvoidnucleic acid preservation capability
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The micro-needle array device is designed to serve multiple functions: it can deliver drugs transdermally through hollow or dissolving needles, collect cellular material for diagnostic purposes through solid needles, and preserve nucleic acids using needles coated with stabilization reagents. This multi-functionality allows a single platform to address various medical needs while maintaining reliability for each specific application

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3355797B1Method for micro-needle sampling
Publication Date: 2023.10.25 GLOBAL LIFE SCI SOLUTIONS OPERATIONS UK LTD
  • EP3355797B1 patent drawingFigure 1A~1C
  • EP3355797B1 patent drawingFigure 2A~2C
  • EP3355797B1 patent drawingFigure 3A~3E

AI summary

The present invention relates to a device (10) for obtaining a sample (30) from a biological material (40) in solid form, said device comprising an array of micro-needles (30) arranged on a base plate (20). It further relates to a method for obtaining a sample (50) from a biological material (40) in solid form, comprising pressing the micro-needles (30) of the device (10) into said biological material (40), and subsequently removing the device from the biological material (40), and to the use of the device (10) in such a method.