Biodegradable Microneedle Array Mold for Pain-Free Tissue Suturing

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Solution Overview

Problem

Conventional suturing methods using physical threads or medical adhesives often result in pain, residual materials, scarring, and difficulties in removing suturing materials from the body, posing challenges in achieving tight and pain-free suturing without side effects.

Innovation Solution

A microneedle array made from biodegradable materials with a long, needle-shaped body and side surface wedges, inspired by a bee's stinger, which allows for tight suturing without pain and minimizes the need for post-suturing removal, combined with a production method involving a mold that transforms two-dimensional patterns into three-dimensional shapes using heat expansion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional physical suturing methods are used, then tight suturing of the affected part is achieved, but pain and tissue damage occur during the suturing process

Engineering Contradiction:
Improvesuturing tightnessVSAvoidpain and tissue damage
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent replaces conventional mechanical thread-based suturing with a microneedle array system that uses micro-scale physical penetration followed by adhesive bonding. The microneedles create minimal puncture wounds that are significantly less traumatic than conventional needle penetration, and the adhesive provides the suturing strength without requiring continuous mechanical tension that causes pain and tissue damage.

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

Solution Approach 2:

The patent changes the scale parameter from macro-scale conventional needles and threads to micro-scale microneedles with dimensions in the micrometer range. This parameter change reduces the harmful effects on tissue while maintaining suturing effectiveness, as the microneedles cause minimal disruption to tissue architecture and the adhesive provides sustained bonding without mechanical stress.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If medical adhesives are used for suturing, then pain-free suturing is achieved, but inflammation is induced due to chemical components

Engineering Contradiction:
Improvepain during suturingVSAvoidinflammation from chemical adhesives
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The patent employs a composite system combining biodegradable microneedles made from materials like polylactic-co-glycolic acid (PLGA) or polycaprolactone (PCL) with medical-grade adhesives. The microneedles provide a physical anchoring structure that reduces the amount of chemical adhesive needed, thereby reducing inflammatory response while maintaining pain-free application.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The microneedles are designed to be biodegradable and automatically dissolve or fragment in the body after providing their anchoring function. This eliminates the need for removal surgery and reduces the duration of foreign body presence, thereby minimizing inflammation and other harmful effects associated with long-term retention of non-biodegradable materials.

Inventive Principle:
Principle #34Discarding and recovering

3Strength

If conventional suturing materials are used, then tight suturing is achieved, but residual materials remain in the body requiring additional removal procedures

Engineering Contradiction:
Improvesuturing tightnessVSAvoidresidual suturing material
Core Design Contradiction:
StrengthVSLoss of substance

Solution Approach 1:

The microneedles are specifically designed with biodegradable materials that break down into harmless byproducts that the body can naturally metabolize or excrete. This eliminates residual foreign materials that would require surgical removal, while the adhesive component provides sustained bonding strength throughout the healing process.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The patent changes the material composition parameter from non-biodegradable conventional suturing materials to biodegradable polymers with controlled degradation rates. This parameter change ensures that the materials maintain their structural integrity and suturing strength during the critical healing period, then gradually degrade and are eliminated from the body without requiring additional intervention.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If complex three-dimensional microneedle structures are produced, then effective suturing function is achieved, but manufacturing complexity and cost increase

Engineering Contradiction:
Improvesuturing effectivenessVSAvoidmanufacturing simplicity and cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent uses preliminary mold fabrication where master molds with precise microneedle patterns are created first using lithography or other precision techniques. These master molds then serve as templates for producing multiple replica molds, which in turn produce the actual microneedle arrays. This preliminary action at the mold-making stage enables complex three-dimensional microneedle structures to be manufactured efficiently through replication, reducing both complexity and cost for mass production.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs replica molding techniques where a master mold with the desired microneedle pattern is used to create multiple identical copies or replicas. This copying approach allows the complex three-dimensional structures to be reproduced accurately and consistently across large quantities, maintaining high reliability and suturing effectiveness while significantly reducing the manufacturing complexity and cost compared to producing each microneedle individually.

Inventive Principle:
Principle #26Copying

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 enables effective, pain-free suturing with minimal side effects and efficient production, as it can be produced inexpensively with a simple process, ensuring tight conjugation without the need for post-suturing material removal.

Implementation Method 1

producing microneedle array molds 10 and 10-2 or 20 and 20-2 having a three-dimensional shape by expanding air inside the patterns 111 or 211 having a two-dimensional shape to deform the patterns 111 or 211 having the two-dimensional shape into a cast form having the three-dimensional shape

Methodology Applied
Scientific EffectAir expansion:

Implementation Method 2

after pouring a biodegradable resin into the microneedle array molds 10 and 10-2 or 20 and 20-2 and solidifying the biodegradable resin

Methodology Applied
Scientific EffectSolidification:

Data Source

PatentUS11596397B2Microneedle, mold for production of microneedle array, and production method of microneedle array using same
Publication Date: 2023.03.07 T&L CO LTD
  • US11596397B2 patent drawing
  • US11596397B2 patent drawing
  • US11596397B2 patent drawing

AI summary

The present invention includes producing a preliminary mold (10-1 or 20-1) provided with two-dimensional patterns (111 or 211) having a shape of a microneedle array (30) therein; producing microneedle array molds (10 and 10-2 or 20 and 20-2) having a three-dimensional shape by expanding air inside the patterns (111 or 211) having a two-dimensional shape to deform the patterns (111 or 211) having the two-dimensional shape into molds having the three-dimensional shape; and after pouring a biodegradable resin into the microneedle array molds (10 and 10-2 or 20 and 20-2) and solidifying the biodegradable resin, completing the microneedle array (30) by removing the microneedle array molds (10 and 10-2 or 20 and 20-2), thereby providing a mold for production of a microneedle array and a production method of the microneedle array using the same capable of tightly suturing an affected area without inducing pain.