Fetal Support Tissue Powder via Lyophilization

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Solution Overview

Problem

Current methods for preparing fetal support tissue products are inefficient in preserving the biological activity and structural integrity of fetal tissues, leading to suboptimal anti-inflammatory, anti-scarring, anti-angiogenic, and wound healing properties.

Innovation Solution

A method involving the lyophilization and grinding of fetal support tissues such as placental amniotic membrane, umbilical cord, chorion, and amnion-chorion to produce a fetal support tissue powder, which is then stored and packaged for therapeutic use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional preparation methods are used for fetal support tissue products, then the processing is simpler, but the biological activity and structural integrity of fetal tissues are not effectively preserved

Engineering Contradiction:
Improvebiological activity preservationVSAvoidprocessing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The tissue is frozen before lyophilization to preserve cellular structure and prevent degradation during the drying process. This preliminary freezing step ensures that the tissue maintains its biological activity and structural integrity throughout subsequent processing steps.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The method employs controlled changes in temperature and pressure parameters during lyophilization to preserve tissue properties. By carefully controlling the freezing temperature, drying pressure, and heating rate, the process maintains biological activity while removing moisture.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If fetal support tissue is processed without freezing and lyophilization, then the processing time is shorter, but the structural integrity and biological activity are compromised

Engineering Contradiction:
Improvestructural integrityVSAvoidprocessing time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

Freezing the tissue before lyophilization creates a stable structure that prevents collapse during moisture removal. This preliminary step ensures structural integrity is maintained throughout the extended processing time required for proper lyophilization.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The method utilizes phase transition from frozen to sublimated state during lyophilization. By transitioning water from solid to vapor phase without passing through liquid phase, the tissue structure is preserved while moisture is removed, maintaining structural integrity.

Inventive Principle:
Principle #36Phase transitions

3Reliability

If fetal support tissue is ground before freezing, then the grinding process is easier, but the biological activity and structural integrity are lost

Engineering Contradiction:
Improvebiological activityVSAvoidgrinding ease
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

Freezing the tissue before grinding makes the tissue brittle and easier to grind into fine powder while preserving biological activity. The frozen state allows for more effective size reduction without compromising the therapeutic properties of the tissue components.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Changing the temperature parameter to frozen state before grinding transforms the mechanical properties of the tissue, making it easier to process while maintaining biological integrity. The low temperature prevents enzymatic degradation and maintains structural stability during mechanical processing.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If fetal support tissue is stored without proper preservation, then the storage conditions are simpler, but the anti-inflammatory, anti-scarring, and wound healing properties deteriorate

Engineering Contradiction:
Improvetherapeutic propertiesVSAvoidstorage requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Lyophilization transforms the tissue into a stable dry powder form that can be stored at ambient temperature while preserving therapeutic properties. The removal of water through phase transition prevents microbial growth and enzymatic degradation, maintaining anti-inflammatory, anti-scarring, and wound healing activities.

Inventive Principle:
Principle #36Phase transitions

Solution Approach 2:

Freezing before lyophilization ensures that the tissue structure is preserved during the drying process, maintaining the therapeutic properties. This preliminary freezing step creates a stable matrix that protects bioactive molecules during subsequent storage.

Inventive Principle:
Principle #10Preliminary action

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 method effectively preserves the biological activity and structural integrity of fetal tissues, resulting in a powder product that exhibits enhanced anti-inflammatory, anti-scarring, anti-angiogenic, and wound healing properties, suitable for treating various conditions including wounds, arthritic conditions, and inflammation.

Implementation Method 1

lyophilizing the frozen fetal support tissue to produce a lyophilized fetal support tissue

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Implementation Method 2

lyophilizing the frozen fetal support tissue

Methodology Applied
Scientific EffectSublimation: Sublimation

Implementation Method 3

The fetal support tissue is frozen prior to lyophilization

Methodology Applied
Scientific EffectFreezing: Freezing

Data Source

PatentEP2717888B1Methods of processing fetal support tissues
Publication Date: 2020.09.09 TISSUE TECHNOLOGIES INC
  • EP2717888B1 patent drawingFigure 1
  • EP2717888B1 patent drawingFigure 2
  • EP2717888B1 patent drawingFigure 3

AI summary

Disclosed herein, are methods of preparing fetal support tissue powders. Further disclosed herein, are methods of using the fetal support tissue powder product.