Extracellular Matrix Grafts Retaining FGF-2 During Sterilization
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Solution Overview
Problem
Existing extracellular matrix tissue graft materials face challenges in maintaining bioactive growth factors like FGF-2 during sterilization, which is crucial for their effectiveness in medical applications such as wound healing and tissue regeneration, as conventional sterilization methods like ethylene oxide and gas plasma significantly reduce these factor levels.
Innovation Solution
A method is developed to control and retain bioactive growth factors like FGF-2 in extracellular matrix materials by optimizing sterilization protocols and using stabilizing solutions, ensuring that the materials retain at least 10% to 50% of their initial FGF-2 levels, and incorporating oxidizing disinfectants for disinfection while minimizing the impact on growth factors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods (ethylene oxide, gas plasma) are used on extracellular matrix materials, then sterility is achieved, but the level of bioactive growth factors (FGF-2) is significantly reduced
Solution Approach 1:
The patent applies preliminary action by adding stabilizing solutions containing growth factor protectants to the extracellular matrix material before sterilization. This pre-treatment protects the growth factors from degradation during the subsequent sterilization process, allowing sterility to be achieved while maintaining growth factor levels.
Solution Approach 2:
The patent uses stabilizing solutions and growth factor protectants as intermediary substances that mediate between the sterilization process and the growth factors. These intermediaries shield the growth factors from the harmful effects of sterilization methods, enabling both sterility and growth factor retention.
2Reliability
If sterilization procedures are applied to packaged extracellular matrix products, then sterility is ensured, but the extractable bioactive growth factor level is affected
Solution Approach 1:
The patent implements feedback by testing sample products from sterilized batches to determine growth factor levels. Based on these test results, the manufacturing process can be adjusted to ensure consistent growth factor levels across production batches, achieving both sterility and precise growth factor control.
Solution Approach 2:
The patent applies parameter changes by modifying sterilization conditions (temperature, time, chemical concentration) and adjusting stabilizing solution composition to optimize the balance between achieving sterility and maintaining growth factor levels. This allows precise control over the final product parameters.
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 maintains high levels of bioactive FGF-2 in extracellular matrix materials, enhancing their bioactivity and suitability for medical applications, particularly in wound healing and tissue regeneration, by carefully managing sterilization processes and using stabilizing solutions.
Implementation Method 1
incorporating oxidizing disinfectants for disinfection while minimizing the impact on growth factors
Data Source
AI summary
Described are packaged, sterile medical graft products containing controlled levels of a growth factor such as Fibroblast Growth Factor-2 (FGF-2). Also described are methods of manufacturing medical graft products wherein processing, including sterilization, is controlled and monitored to provide medical graft products having modulated, known levels of a extracellular matrix factor, such as a growth factor, e.g. FGF-2. Preferred graft materials are extracellular matrix materials isolated from human or animal donors, particularly submucosa-containing extracellular matrix materials. Further described are ECM compositions that are or are useful for preparing gels, and related methods for preparation and use.