Multi-Layer Amnion Patches for Adhesion Prevention

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Solution Overview

Problem

Current medical dressings, particularly those using amniotic tissue, face challenges in preventing fibrotic infiltration and adhesion formation post-surgery or trauma, leading to complications such as scarring and tissue integration issues.

Innovation Solution

The development of multi-layer tissue patches with epithelial layers on both sides, where the fibroblast layers are intertwined or mated to enhance mechanical strength and prevent adhesions, utilizing amnion tissue processed with glutaraldehyde to create a durable and anti-adhesion barrier.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If single-layer amniotic tissue is used as a medical dressing, then the dressing is simple and easy to manufacture, but it fails to effectively prevent fibrotic infiltration and adhesion formation

Engineering Contradiction:
Improveadhesion prevention capabilityVSAvoiddressing structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The amniotic tissue is divided into multiple distinct layers (first amniotic layer and second amniotic layer) with each layer having specific functional properties. The first layer presents an epithelial surface and the second layer presents a fibroblast surface, creating segmented functional zones that work together to prevent adhesion formation more effectively than a single-layer structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-layer two-dimensional structure to a multi-layer three-dimensional configuration. By stacking multiple amniotic layers with different surface characteristics (epithelial and fibroblast surfaces), the dressing gains enhanced dimensional complexity that improves its ability to barrier fibrotic infiltration while maintaining flexibility.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If multi-layer amniotic tissue patches are used to prevent adhesions, then adhesion formation is inhibited, but the manufacturing process becomes more complex

Engineering Contradiction:
Improveanti-adhesion barrierVSAvoidprocessing complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

Multiple amniotic layers are combined into a single integrated multi-layer dressing structure where the layers are joined together to form a cohesive unit. This merging process creates a durable anti-adhesion barrier while the layered configuration allows each layer to contribute specific protective functions, making the manufacturing process manageable through systematic combination of standardized layers.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The dressing is constructed as a composite material system combining multiple amniotic tissue layers with different surface properties (epithelial and fibroblast surfaces). This composite structure provides enhanced anti-adhesion properties while the use of natural amniotic tissue materials simplifies processing compared to synthetic alternatives, as the layers naturally adhere through their biological properties.

Inventive Principle:
Principle #40Composite materials

3Strength

If fibroblast layers are intertwined or mated between layers, then mechanical strength is enhanced, but the processing time and complexity increase

Engineering Contradiction:
Improvemechanical strengthVSAvoidprocessing time
Core Design Contradiction:
StrengthVSLoss of time

Solution Approach 1:

The fibroblast layers are pre-positioned and pre-aligned between the amniotic layers during the assembly process, so that when the dressing is finalized, the fibroblast layers are already in their intertwined or mated configuration. This preliminary arrangement of fibroblast layers ensures mechanical strength is built-in during manufacturing rather than requiring additional post-processing time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The fibroblast layers naturally intertwine or mate with each other through their biological properties when positioned between the amniotic layers, without requiring external intervention or complex processing. The fibroblast cells autonomously establish their interconnected structure, providing mechanical strength while minimizing processing time and complexity.

Inventive Principle:
Principle #25Self-service

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 multi-layer patches effectively inhibit adhesion formation, providing a strong and durable barrier for surgical sites, allowing for improved tissue healing and reduced scarring, suitable for various surgical procedures and trauma treatments.

Implementation Method 1

processing the first and second amnion layers so that at least a portion of the fibroblast layer of the first amnion layer is operatively associated with or adhered with at least a portion of the fibroblast layer of the second amnion layer

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

utilizing amnion tissue processed with glutaraldehyde to create a durable and anti-adhesion barrier

Methodology Applied
Scientific EffectChemical cross-linking: Chemical Bonding

Data Source

PatentUS9480549B2Multi-layer tissue patches
Publication Date: 2016.11.01 ALLOSOURCE
  • US9480549B2 patent drawing
  • US9480549B2 patent drawing
  • US9480549B2 patent drawing

AI summary

Embodiments of the present invention encompass anti-adhesion wound dressings including patches made from amnion tissue obtained from human birth tissue. Exemplary amnion patches can be fabricated by folding a section of amnion over on itself with the epithelial layer on the outside of the folded patch and the fibroblast layer on the inside of the folded patch. Optionally, individual amnion tissue pieces can be sandwiched together to provide a multi-layer patch. Sufficient pressure is applied to the layered amnion to cause adherence between opposing faces of the fibroblast layers. The pressed fibroblast layers provide mechanical strength to hold the amnion patch together with the epithelial layers on the outsides of the amnion patch.