Cross-Linked Amniotic Membrane Wound Covering
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Solution Overview
Problem
There is a need for wound coverings made from amniotic and chorionic membranes that are uniquely processed to enhance their physical properties and can be stored for easy use, while preventing fibrous scar formation and promoting advanced healing in various surgical and non-surgical applications.
Innovation Solution
The development of cross-linked amniotic and chorionic membranes, treated with glutaraldehyde and ethanol, followed by terminal sterilization via gamma or electron beam irradiation, to create a wound covering that inhibits scar formation and facilitates healing by forming a physical barrier.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If amniotic and chorionic membranes are processed with cross-linking solutions and terminal sterilization, then their physical properties are enhanced and storage stability is improved, but the processing complexity and time required increase
Solution Approach 1:
The membranes are cross-linked with glutaraldehyde solution before terminal sterilization, performing the cross-linking action in advance to stabilize the tissue structure. This preliminary cross-linking enhances the membranes' physical properties and storage stability, making them more resistant to degradation during subsequent handling and storage, while the sterilization step completes the preparation process
Solution Approach 2:
The patent applies specific parameter ranges for cross-linking (0.05% to 3% glutaraldehyde concentration) and sterilization (gamma or electron beam irradiation) to optimize the balance between enhancing physical properties and maintaining tissue functionality. By controlling these parameters, the processing achieves improved storage stability without excessive complexity
2Reliability
If the membranes are cross-linked and sterilized to enhance physical properties, then wound protection and anti-scar formation are improved, but the manufacturing time and processing steps increase
Solution Approach 1:
The patent replaces traditional mechanical or chemical sterilization methods with terminal sterilization via gamma irradiation or electron beam irradiation. This substitution allows for effective sterilization and enhancement of physical properties without requiring extended processing times or multiple sequential steps, thereby improving wound protection while minimizing manufacturing time
Solution Approach 2:
By optimizing the cross-linking parameters (glutaraldehyde concentration and exposure time) and sterilization parameters (irradiation dose), the process achieves reliable wound protection and anti-scar formation properties in a time-efficient manner, balancing quality enhancement with manufacturing speed
3Reliability
If the membranes are treated with multiple solutions and sterilized, then their anti-microbial effects and healing promotion are enhanced, but the number of processing steps and complexity increase
Solution Approach 1:
The patent combines cross-linking and sterilization into a unified processing sequence where glutaraldehyde cross-linking is performed first to stabilize the tissue and provide anti-microbial properties, followed by terminal sterilization via irradiation to eliminate contaminants. This merging of functions into a coordinated process enhances anti-microbial effects and healing promotion while managing processing complexity through integration rather than separate sequential steps
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 cross-linked membrane wound coverings effectively prevent fibrous scar formation, reduce adhesions, and promote advanced healing in surgical and non-surgical wounds, including diabetic ulcers and venous leg ulcers, by providing a structural barrier and enhancing tissue regeneration.
Implementation Method 1
The membrane(s) is/are cross-linked with a cross-linking solution comprising from about 0.05% to about 3% glutaraldehyde
Implementation Method 2
Terminal sterilization is carried out via gamma irradiation or electron beam irradiation
Implementation Method 3
Terminal sterilization is carried out via gamma irradiation or electron beam irradiation
Data Source
AI summary
A wound covering fabricated from amniotic, chorionic, or intact amniotic and chorionic membranes obtained from human birth tissue is provided. Methods of processing a membrane to form a wound covering are provided. Methods of treating a wound or surgical incision are also provided.