Microneedle Manufacturing with Separation Layer and Wire-Type Pores
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Solution Overview
Problem
Existing microneedle technologies face challenges in achieving precise drug delivery with controlled mechanical strength and rapid deployment, as they often require lengthy dissolution times and struggle with uniform air pocket formation, leading to inconsistent mechanical strength and drug delivery issues.
Innovation Solution
A manufacturing method involving a lower mold with a microneedle intaglio and a shape control mold with wire-shaped protrusions, where a polymer solution is injected and cured to form a microneedle with a designed shape and size, allowing for controlled dissolution and rapid deployment by forming a wire-type pore that can be dissolved by body fluids or external solvents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If centrifugation is used to form an air pocket inside the microneedle, then the microneedle can be detached from the mold, but the side wall thickness of the air pocket becomes non-uniform and mechanical strength is reduced
Solution Approach 1:
A separation layer is pre-formed between the microneedle and mold base layer before final curing, enabling easy detachment without centrifugation. This preliminary separation structure prevents the need for post-forming air pockets while ensuring clean mold release.
Solution Approach 2:
A separation layer acts as an intermediary between the microneedle structure and the mold base layer, facilitating detachment while maintaining the integrity and uniform thickness of the microneedle walls. This intermediary layer solves both the detachment problem and the wall thickness uniformity issue.
2Reliability
If the microneedle is made from biocompatible polymer material for implantable use, then it can be biodegraded for drug delivery, but the dissolution time is too long causing inconvenience
Solution Approach 1:
The microneedle structure incorporates different regions with different dissolution characteristics. The tip portion dissolves rapidly to deliver the drug payload, while the base portion maintains structural integrity longer. This local differentiation enables both rapid drug delivery and controlled dissolution.
Solution Approach 2:
The microneedle is constructed as a composite structure with the separation layer and different polymer regions, combining materials with different degradation rates. This composite approach allows the microneedle to exhibit both rapid initial dissolution for drug release and sustained structural support.
3Object-affected harmful factors
If the microneedle diameter is reduced to tens or hundreds of micrometers for painless penetration, then tissue trauma is minimized, but the mechanical strength to withstand penetration pressure becomes insufficient
Solution Approach 1:
The microneedle array is segmented into multiple individual microneedles arranged in parallel, where each microneedle has a small diameter for painless penetration. The collective array structure provides the necessary mechanical strength through distributed load bearing across multiple elements.
Solution Approach 2:
The microneedles are designed with optimized wall thickness and geometric profiles that provide sufficient mechanical strength despite small diameters. The separation layer and base layer provide additional structural support while maintaining flexibility for tissue penetration.
4Ease of manufacture
If a simple manufacturing process is used for mass production, then manufacturing cost is reduced, but the ability to control air pocket location, arrangement, and shape is lost
Solution Approach 1:
The separation layer is pre-formed in the mold before microneedle fabrication, establishing the exact location, shape, and arrangement of the separation region. This preliminary structuring eliminates the need for complex post-processing or centrifugation while maintaining precise control over the separation characteristics.
Solution Approach 2:
The complex centrifugal force-based air pocket formation is replaced with a simpler mold-based separation layer formation process. This substitution uses static mold geometry rather than dynamic centrifugal forces, simplifying the manufacturing process while maintaining precision.
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
This method enables the production of microneedles with enhanced mechanical strength, precise drug delivery, and rapid utilization time, while allowing for controlled drug release and improved biosolubility, facilitating efficient and painless delivery of medications.
Implementation Method 1
injecting a polymer solution containing a biocompatible polymer into a lower mold that includes a microneedle intaglio
Implementation Method 2
coupling a shape control mold to the lower mold to impregnate one end of a protrusion included in the shape control mold into the biocompatible polymer solution injected into the microneedle intaglio
Implementation Method 3
allowing for controlled dissolution and rapid deployment by forming a wire-type pore that can be dissolved by body fluids or external solvents
Data Source
AI summary
A microneedle structure, a manufacturing method therefor, and a manufacturing apparatus therefor are presented. The microneedle structure manufacturing method according to one embodiment of the present invention comprises the steps of: a) injecting, into a lower mold comprising a microneedle intaglio, a polymer solution containing a biocompatible polymer; and b) coupling a shape control mold, which comprises a protrusion, to the lower mold such that one end of the protrusion of the shape control mold is impregnated with the biocompatible polymer solution injected into the microneedle intaglio.