Microneedle Array With Dissolvable Separation Layer

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Solution Overview

Problem

Current methods for transdermal delivery of bioactive compounds face limitations, including pain, risk of infection, and restricted delivery of compound types due to the stratum corneum barrier, as well as complexities and mechanical malfunctions in microneedle array systems.

Innovation Solution

A microneedle array device comprising a base layer, a bioactive layer, and a separation layer that dissolves under physiological conditions, allowing the bioactive layer to remain embedded in the skin while the base layer is removed, reducing pain and infection risk and enabling targeted, efficient delivery of bioactive compounds.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If hypodermic needles are used for transdermal administration, then bioactive compounds can be delivered, but pain and risk of infection from bloodborne pathogens occur

Engineering Contradiction:
Improvedelivery of bioactive compoundsVSAvoidpain and infection risk
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The microneedle array divides the delivery system into multiple fine needles (e.g., 19 needles in a 4x5 array) instead of a single large needle, reducing pain while maintaining delivery capability. Each microneedle is 150-200 μm in diameter compared to traditional needle diameters, creating numerous small puncture sites that minimize discomfort and tissue damage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The microneedle arrays are designed as single-use disposable devices that are discarded after one administration. This eliminates the risk of bloodborne pathogen transmission from reused needles while maintaining cost-effectiveness through standardized manufacturing processes.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Object-affected harmful factors

If transdermal patches are used for delivery, then infection risk is reduced, but delivery is restricted to lipophilic molecules of small size due to the stratum corneum barrier

Engineering Contradiction:
Improveinfection riskVSAvoidtypes of compounds that can be delivered
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The microneedles physically pre-pierce the stratum corneum barrier before compound delivery, creating micro-channels that allow subsequent deposition of various bioactive compounds. This preliminary mechanical action enables delivery of hydrophilic, large molecular weight, and peptide compounds that would otherwise be blocked by the intact stratum corneum.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The microneedles create localized delivery zones at specific skin penetration points, allowing different compounds to be delivered to different locations. The array configuration enables spatially resolved delivery where each microneedle can target specific areas, providing versatility in compound delivery while maintaining intact surrounding skin barriers.

Inventive Principle:
Principle #3Local quality

3Ease of operation

If microneedle arrays with surface-coated bioactive compounds are used, then delivery is simplified, but the amount of bioactive compound that can be administered is limited

Engineering Contradiction:
Improvedelivery simplicityVSAvoidamount of bioactive compound
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The microneedles are constructed as composite structures with a dissolvable core material (sugar glass, gelatin, or starch) and a separate bioactive compound layer. This composite design allows the core to provide structural integrity and controlled dissolution while the bioactive layer contains concentrated therapeutic agents, significantly increasing the deliverable compound quantity compared to simple surface coating.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The microneedle core material undergoes parameter changes through controlled dissolution in physiological fluids, transitioning from a solid structural form to a soluble state that releases the bioactive compounds. This dissolution parameter change enables sustained release of larger compound quantities over time, overcoming the limitations of immediate surface-coated delivery.

Inventive Principle:
Principle #35Parameter changes

4Quantity of substance

If hollow microneedles with reservoirs are used, then larger amounts of bioactive compounds can be delivered, but the systems become complex and susceptible to mechanical malfunction

Engineering Contradiction:
Improveamount of bioactive compoundVSAvoidsystem complexity and mechanical malfunction risk
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the complex reservoir and hollow needle structure, replacing it with a simple solid microneedle where the bioactive compound is incorporated into or on the needle itself. This extraction of the reservoir component dramatically simplifies the device architecture, eliminating mechanical failure points while maintaining compound delivery capability through the dissolvable needle mechanism.

Inventive Principle:
Principle #2Taking out (Extraction)

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 microneedle array system provides controlled, targeted delivery of bioactive compounds, minimizing non-bioactive component deposition and reducing pain and infection risk, while allowing for precise administration of compounds to specific skin sites.

Implementation Method 1

a separation layer comprising one or more compounds that dissolve or disperse under physiological conditions, wherein the separation layer is situated between the base layer and the bioactive layer

Methodology Applied
Scientific EffectDissolution:

Data Source

PatentUS20240075267A1Microneedle Array Device, Methods Of Manufacturing And Use Thereof
Publication Date: 2024.03.07 NANOCAV LLC
  • US20240075267A1 patent drawing
  • US20240075267A1 patent drawing
  • US20240075267A1 patent drawing

AI summary

Systems and methods for using microneedle arrays to deliver bioactive compounds are presented. In general, the microeconomic array comprises at least three layers: a base layer, a separation layer, and a bioactive layer, wherein the separation layer is situated between the base layer and the bioactive layer. Upon exposure to physiological conditions, the separation layer dissolves and/or disperses, allowing the base layer to be removed while the bioactive layer remains embedded in the outer surface of the skin.