Cryo Microneedle Device for Transdermal Bioactive Delivery

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Solution Overview

Problem

Existing microneedle devices face limitations in drug loading, mechanical stability, and the ability to deliver fragile active agents such as cells and proteins, with complex fabrication processes and potential breakage issues, making them unsuitable for transdermal delivery of bioactive therapeutic agents in cancer immunotherapy.

Innovation Solution

A cryo formulation-based microneedle device made from an aqueous solution with bioactive therapeutic agents, fabricated by freezing to form a solid state, allowing for controlled penetration and release of agents into the skin, with optimized bioactivity and mechanical properties for effective delivery of cells and proteins.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional microneedle devices are used for transdermal delivery, then mechanical stability and structural integrity are improved, but the ability to deliver fragile bioactive agents such as cells and proteins deteriorates

Engineering Contradiction:
Improvemechanical stabilityVSAvoidbioactivity preservation
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The invention changes the physical state parameter of the microneedle material from solid (conventional) to ice/cryo state. This parameter change allows the microneedles to be soft and flexible during application, preventing breakage of fragile bioactive agents, while maintaining sufficient mechanical stability for skin penetration through controlled freezing

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses composite materials by combining ice/cryo matrix with cryoprotectants and bioactive therapeutic agents. The cryoprotectants form a protective composite structure that maintains both mechanical integrity of the microneedle and viability of embedded cells and proteins during freezing and storage

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If conventional microneedle devices are used, then drug loading capacity is improved, but the complexity of fabrication process and potential breakage issues increase

Engineering Contradiction:
Improvedrug loadingVSAvoidfabrication complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The invention applies preliminary action by pre-freezing the microneedle array with embedded bioactive agents in a cryo formulation before application. This preliminary freezing step simplifies the overall process by eliminating the need for complex post-fabrication drug loading procedures and ensures stable drug loading capacity from the outset

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention replaces complex mechanical fabrication processes with a simpler freezing-based approach. Instead of using complex molding and assembly processes for conventional microneedles, the invention uses freezing of a cryo formulation to simultaneously create the microneedle structure and embed the therapeutic agents, reducing fabrication complexity

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

3Reliability

If intradermal injection is used for delivering bioactive agents, then delivery effectiveness is improved, but patient comfort and ease of operation deteriorate

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidpatient comfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention extracts the needle insertion step from traditional intradermal injection by using dissolving microneedles that penetrate skin passively or with minimal force, then dissolve after delivery. This removes the need for forceful injection while maintaining effective intradermal delivery of bioactive agents

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The microneedles are designed as disposable, short-lived devices that dissolve after use. This eliminates the need for complex injection mechanisms and makes the device easier to operate, while ensuring single-use sterility and effectiveness for delivering bioactive agents

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

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 cryo formulation-based microneedle device enables targeted and minimally invasive delivery of bioactive agents, maintaining viability and bioactivity, and simplifies the application process by integrating cells directly into the device, enhancing antitumor immunity through antigen-presenting cells and immune checkpoint inhibitors.

Implementation Method 1

fabricated by freezing to form a solid state

Methodology Applied
Scientific EffectFreezing: Freezing

Implementation Method 2

the miniaturized needles is further arranged to melt so as to release one or more bioactive therapeutic agents into the skin

Methodology Applied
Scientific EffectMelting: Melting

Data Source

PatentUS12005221B2Cryo formulation-based microneedle device for transdermal delivery of bioactive therapeutic agents and cancer immunotherapy using a cryo-microneedle patch
Publication Date: 2024.06.11 CITY UNIVERSITY OF HONG KONG
  • US12005221B2 patent drawing
  • US12005221B2 patent drawing
  • US12005221B2 patent drawing

AI summary

A cryo formulation-based microneedle device for transdermal delivery of bioactive therapeutic agents. The microneedle device includes: one or more microneedle patches each including an array of miniaturized needles, wherein each miniaturized needle defining a base end and a tip; and a substrate to which the base end of the array of miniaturized needles is attached or integrated thereto; wherein the microneedle patch is in a cryo status; wherein each of the one or more microneedle patch is adapted to be applied on a skin surface, in which the miniaturized needles penetrates into skin; and wherein the miniaturized needles is further arranged to melt so as to release one or more bioactive therapeutic agents into the skin to achieve a targeted therapeutic effect.