Metal Microneedle Array Wire Cutting for Batch Precision Manufacturing

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Solution Overview

Problem

Current microneedle manufacturing technologies face challenges such as high costs, low processing efficiency, and poor biocompatibility, particularly with silicon and brittle materials like glass and ceramics, which limit batch production and safety for transdermal drug delivery.

Innovation Solution

A sheet in-plane metal microneedle array made from stainless steel or titanium alloy, processed using a wire cutting method with a clamping tooling system that ensures high accuracy, efficiency, and low cost, allowing for batch production and flexible assembly into three-dimensional arrays.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If silicon microneedles are used for transdermal drug delivery, then processing accuracy can be achieved through photolithography and etching, but manufacturing cost increases and batch production efficiency decreases

Engineering Contradiction:
Improvemicroneedle tip precisionVSAvoidbatch production efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent replaces complex photolithography and etching processes with a mechanical wire cutting system. A wire electrode directly cuts metal sheets to form microneedles, eliminating the need for chemical etching and multiple lithography steps. This mechanical substitution enables batch production of microneedles with high precision while significantly improving manufacturing efficiency and reducing costs.

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

2Manufacturing precision

If brittle materials like glass and ceramics are used for microneedles, then manufacturing precision can be maintained, but reliability and safety decrease due to fracture risk

Engineering Contradiction:
Improvemicroneedle dimensional accuracyVSAvoidmicroneedle fracture resistance
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent uses metal sheets (such as stainless steel or biocompatible alloys) as the base material for microneedles. These metallic materials provide both the necessary manufacturing precision for microneedle formation and superior mechanical properties including fracture resistance, toughness, and flexibility compared to brittle materials like glass and ceramics.

Inventive Principle:
Principle #40Composite materials

3Speed

If conventional hypodermic needles are used for drug injection, then drug delivery speed is fast, but patient pain and tissue invasiveness increase

Engineering Contradiction:
Improvedrug delivery speedVSAvoidpatient pain and tissue damage
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent divides a single large hypodermic needle into multiple small microneedles arranged in an array on a metal sheet. Each microneedle has a tip diameter of tens of microns or less, which is much smaller than conventional needles. This segmentation allows the array to pierce the stratum corneum effectively while minimizing pain and tissue damage, as the small size prevents activation of pain receptors and reduces mechanical trauma.

Inventive Principle:
Principle #1Segmentation

4Reliability

If transdermal drug delivery is used to avoid gastrointestinal metabolism, then drug bioavailability improves, but drug delivery dose and efficiency remain limited due to stratum corneum barrier

Engineering Contradiction:
Improvedrug bioavailabilityVSAvoiddrug delivery dose
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent creates localized pathways through the stratum corneum using microneedles. The microneedle array creates multiple micro-channels that concentrate drug delivery at specific penetration sites, overcoming the barrier effect of the stratum corneum. This localized approach enables sufficient drug dose delivery while maintaining the advantages of transdermal administration, including avoidance of first-pass metabolism and gastrointestinal side effects.

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

The method enables cost-effective, high-accuracy production of metal microneedle arrays with improved biocompatibility and toughness, enhancing transdermal drug delivery efficiency and safety by simplifying the processing procedure and reducing material waste.

Implementation Method 1

processed using a wire cutting method with a clamping tooling system

Methodology Applied
Scientific EffectWire cutting: Electrical Discharge Machining

Data Source

PatentUS11738185B2In-plane metal microneedle array and manufacturing method therefor
Publication Date: 2023.08.29 DALIAN UNIV OF TECH
  • US11738185B2 patent drawing
  • US11738185B2 patent drawing
  • US11738185B2 patent drawing

AI summary

An in-plane metal microneedle array and a manufacturing method therefor is disclosed. A large-size metal sheet is cut into small metal sheets. Inner sides of the upper and the lower cover plates of the tooling are provided with grooves matched with the sizes of the small metal sheets. Through holes are formed at edges around the cover plates. The metal sheets are placed in the grooves and fastened through bolts. The geometry and the size of a sheet microneedle array are designed, and a CAD model of the plane microneedles is built. A wire path is cut according to the CAD model. A few materials are reserved on both sides of substrates of the microneedle array without cutting. The unprocessed parts on both sides of the microneedle substrate are cut to obtain an in-plane metal microneedle array with a plurality of microneedle bodies.