Propylene Oxide Sterilization for Collagen Biomaterials
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Solution Overview
Problem
Current sterilization methods for collagen-based biomaterials, such as gamma irradiation and chemical agents, can cause structural damage and tissue degeneration, while storage solutions often lead to calcification and fibrosis, making them unsuitable for long-term use.
Innovation Solution
A process involving a sterilization solution of 3-6% propylene oxide, without alcohol, is used to sterilize and store cross-linked collagen-based biomaterials by incubating them between 30°C and 55°C for greater than 48 hours, allowing propylene oxide to convert to propylene glycol, which is non-toxic and suitable for long-term storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma irradiation or chemical agents are used for sterilization, then sterilization efficiency is improved, but structural damage and tissue degeneration occur
Solution Approach 1:
The patent changes the chemical parameters of the sterilization solution by using propylene oxide at controlled concentrations (0.5-5% v/v) and temperatures (20-50°C) to achieve sterilization without the harsh conditions that cause tissue damage. This parameter optimization allows effective sterilization while preserving tissue integrity.
Solution Approach 2:
The patent employs a disposable sterilization solution that is inexpensive and can be easily replaced. The propylene oxide-based solution is used once for sterilization and then discarded, eliminating the need for complex sterilization equipment and reducing the risk of repeated exposure to damaging sterilization conditions.
2Reliability
If aldehyde-based storage solutions are used, then contamination protection is improved, but calcification and fibrosis occur
Solution Approach 1:
The patent extracts and removes harmful aldehyde components from the storage solution while retaining the essential protective functions. By using propylene oxide without alcohol and aldehydes, the solution maintains contamination protection through a different mechanism that does not induce calcification or fibrosis.
Solution Approach 2:
The patent introduces propylene oxide as an intermediary substance that provides the necessary protection against contamination during storage without causing the harmful effects of aldehydes. This intermediary agent mediates between the need for protection and the avoidance of tissue damage.
3Reliability
If alcohol is added to propylene oxide sterilization, then sterilization effectiveness is improved, but residual aldehyde levels increase and calcification potential increases
Solution Approach 1:
The patent converts the potential harm of using propylene oxide alone (insufficient sterilization) into a benefit by carefully controlling the concentration and conditions to achieve effective sterilization without needing alcohol additives. The controlled environment transforms a potentially harmful situation into a safe and effective process.
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 effectively sterilizes collagen-based biomaterials while preventing calcification and maintaining tissue integrity, allowing for safe and effective storage and potential implantation without adverse biological effects.
Implementation Method 1
allowing propylene oxide to convert to propylene glycol
Data Source
AI summary
The present invention relates to a process for sterilizing implantable biomaterials. In particular, the invention relates to a process for sterilizing collagen-containing implantable biomaterials and storage thereafter.