Polymeric Microneedle Structures for Rapid CLIP Manufacturing
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Solution Overview
Problem
Current microneedle fabrication processes are time-consuming, expensive, and limit control over shape and design, hindering the commercialization and effective scale-up of polymeric microneedles.
Innovation Solution
Microneedle devices with biocompatible features such as curved, discontinuous, undercut, or perforated sidewalls, breakable supports, non-circular cross-sections, and tiered structures, fabricated using Continuous Liquid Interface Printing (CLIP) technology, which allows for rapid additive manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional microfabrication techniques (DRIE, wet etching, laser ablation) are used to create master microneedles, then microneedles can be fabricated with controlled shape, but the process is time-consuming (1.5+ hours per master) and requires expensive equipment
Solution Approach 1:
The patent uses 3D printing to directly create master microneedles as digital copies of desired geometries, eliminating the need for traditional multi-step microfabrication processes. This allows rapid prototyping and iteration of microneedle designs without requiring cleanroom facilities or expensive etching equipment, while maintaining precise shape control through digital modeling.
Solution Approach 2:
The invention changes the fundamental fabrication parameter from subtractive manufacturing (etching away material) to additive manufacturing (building up material layer by layer). This parameter change enables faster fabrication times and greater design flexibility, as complex geometries can be built directly without multiple masking and etching steps.
2Manufacturing precision
If extensive process optimization is performed to generate microneedle structures using traditional methods, then manufacturing precision improves, but substantial lead time is required
Solution Approach 1:
The patent performs preliminary design and optimization in the digital domain using CAD software before physical fabrication. This allows extensive geometric optimization, structural analysis, and parameter tuning to be completed virtually, eliminating the need for iterative physical prototyping and reducing overall lead time while maintaining high manufacturing precision.
Solution Approach 2:
The invention replaces mechanical microfabrication processes with digital design and additive manufacturing. This substitution eliminates the need for extensive process optimization of chemical etching parameters, masking alignments, and physical tooling, thereby dramatically reducing lead time while preserving structural precision through digital control.
3Ease of manufacture
If vacuum and centrifugation steps are used to fill molds with microneedle formulations, then microneedles can be formed, but these time-consuming steps (hours to days) limit cost-effective scale-up
Solution Approach 1:
The patent combines the master fabrication and mold formation steps into a single 3D printing process. The printed master serves directly as the mold for creating microneedle arrays, eliminating the need for separate vacuum and centrifugation filling steps. This integration dramatically reduces processing time and enables scalable production.
Solution Approach 2:
The invention extracts and eliminates the time-consuming vacuum and centrifugation steps from the manufacturing process by using direct 3D printing to form microneedles. This removal of unnecessary steps increases productivity and enables cost-effective scale-up while maintaining ease of manufacture through a simplified process flow.
4Reliability
If microneedle size, shape, sharpness, aspect ratio, and spacing are optimized for ideal skin insertion, then insertion success improves, but current fabrication limitations prevent achieving ideal designs
Solution Approach 1:
The patent enables local optimization of microneedle properties by allowing different geometries, materials, and structures to be printed for different regions of the microneedle array. Each microneedle can be independently optimized for its specific function (e.g., varying tip sharpness, aspect ratios, or spacing) to maximize skin insertion success, without being constrained by uniform manufacturing limitations.
Solution Approach 2:
The invention utilizes composite material approaches in 3D printing, combining different polymers, drugs, and functional materials within the microneedle structure. This allows simultaneous optimization of mechanical properties for insertion, structural integrity, and therapeutic function, achieving ideal designs that were previously impossible with traditional homogeneous fabrication methods.
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 efficient and cost-effective production of microneedles with optimized morphology and spacing, enhancing skin insertion and delivery of therapeutic agents or biomarker detection.
Implementation Method 1
fabricated using Continuous Liquid Interface Printing (CLIP) technology
Data Source
AI summary
The invention generally relates to microneedle devices, methods of making same, pharmaceutical compositions comprising same, and methods of treating a disease comprising administering same. Specifically, the disclosed microneedle devices comprise a plurality of biocompatible microneedles having one or more of: (i) a curved, discontinuous, undercut, and/or perforated sidewall; (ii) a sidewall comprising a breakable support; and (iii) a cross-section that is non-circular and non-polygonal. The microneedles may also be tiered. Alternatively, the microneedles may be tiered. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention.