Amniotic Membrane Material Sterilization via Lyophilization
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Solution Overview
Problem
Existing methods for processing amniotic membranes into materials for tissue reconstruction and healing require final radiation sterilization, which can damage the material and alter its properties, including growth factors, due to gamma-radiation-induced mutations and cell death.
Innovation Solution
A method involving the separation of the amniotic membrane from the chorion, purification in saline and antibiotic solutions based on color assessment, application to a textile carrier, and lyophilization, followed by a sterile coating, eliminating the need for final radiation sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiation sterilization is used to sterilize the amniotic membrane material, then sterilization is achieved, but the structure and properties of growth factors and cytokines are damaged
Solution Approach 1:
The amniotic membrane is processed and packaged under sterile conditions before final assembly, eliminating the need for post-processing radiation sterilization. The membrane is separated from chorion, purified in saline, and assembled with textile carriers in a controlled sterile environment, preserving growth factors while achieving sterilization
Solution Approach 2:
The harmful radiation sterilization step is removed from the process entirely. Instead of using radiation to achieve sterilization, the process extracts and maintains sterility through controlled processing environments and sterile packaging techniques, thereby eliminating damage to biological molecules
2Reliability
If radiation sterilization is used, then sterilization is achieved, but special equipment is required
Solution Approach 1:
The radiation sterilization step requiring special equipment is completely removed from the process. Sterilization is achieved through standard sterile processing techniques and packaging methods that do not require radiation equipment
Solution Approach 2:
The system achieves sterilization through self-contained sterile processing and packaging methods that are integrated into the manufacturing process itself, eliminating the need for separate radiation sterilization equipment and 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
This method maintains the integrity of the amniotic membrane's structure and growth factors, enhancing tissue healing without the adverse effects of radiation sterilization, and is suitable for chronic wound coverage and other tissue reconstruction applications.
Implementation Method 1
f) lyophilization of the resulting material obtained in step e)
Data Source
AI summary
The present invention relates to a method of processing of amniotic membrane to form materials for reconstruction, protection and enhancement of damaged tissues healing, said method starting from placenta, wherein said method comprises the following steps:a) separation of an amniotic membrane from a chorion,b) purification of the amniotic membrane in saline solution and mechanical cleaning of the amniotic membrane,(c) assessment of purity of the amniotic membrane based on its color,d) purification of the amniotic membrane in a saline solution containing an antibiotic, and subsequent reassessment of purity of the amniotic membrane based on its color,e) applying the amniotic membrane by its epithelial side onto a textile carrier,f) lyophilization of the resulting material obtained in step e),g) enclosure of the lyophilized material in a sterile coating.The invention further relates to a material obtainable by this method, to this material for use for covering chronical wounds, and to the use of color classification means in a color system for assessing the purity of the amniotic membrane in the method according to the present invention.