E Beam Sterilization of Heparin Coated Medical Devices
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Solution Overview
Problem
Conventional sterilization methods, such as ethylene oxide and gamma radiation, often damage or reduce the effectiveness of bioactive coatings on medical devices, particularly heparin coatings, leading to stability and shelf life issues.
Innovation Solution
The use of an E beam sterilization process, specifically packaging medical devices with bioactive heparin coatings under vacuum with drying agents and applying a controlled dose of E beam radiation to maintain and even enhance the biological activity of the heparin coating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods (ethylene oxide, gamma radiation) are used, then sterilization is achieved, but the bioactive coating stability is diminished
Solution Approach 1:
The patent changes the sterilization parameters by using E beam radiation instead of conventional ethylene oxide or gamma radiation methods. This parameter change allows sterilization to be achieved while preserving coating stability, as E beam radiation at controlled doses does not damage the bioactive coating materials unlike traditional methods
Solution Approach 2:
The patent converts the potentially harmful effect of radiation on bioactive coatings into a beneficial outcome by using E beam radiation to sterilize while actually enhancing or maintaining coating stability. The controlled E beam dose acts as a benefit rather than a harm, achieving both sterilization and coating preservation
2Stability of the object's composition
If E beam sterilization is used, then coating stability is maintained, but the biological activity of heparin coating may be reduced
Solution Approach 1:
The patent optimizes the E beam radiation dose parameter to achieve the desired balance. By controlling the E beam dose within specific ranges, the patent maintains coating stability while preserving or enhancing the biological activity of the heparin coating, converting a potential negative effect into a beneficial one
3Reliability
If traditional sterilization methods are used, then sterilization is achieved, but shelf life is reduced
Solution Approach 1:
The patent changes the sterilization method parameter from conventional methods to E beam radiation, which fundamentally alters the interaction with the coating materials. This parameter change enables both sterilization and extended shelf life by avoiding the degradation mechanisms of traditional methods
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 E beam process effectively preserves and can revive the biological activity of heparin coatings, extending their shelf life and ensuring sterility without the drawbacks of traditional methods, as demonstrated by increased heparin activity and optimal dose response.
Implementation Method 1
sterilizing the packaged medical devices and its bioactive coatings with an E beam process of a suitable dose
Data Source
AI summary
The invention provides a method for single-step terminal sterilization process for bio-active heparin coatings on materials and biomaterials containing heparin used in medical devices, such as catheters, tissue engineering scaffolds, or drug delivery carrier materials. This may include any medical device or implantable that could benefit from improved antithrombotic and biocompatible heparin surfaces. Other relevant device examples may include heparin or a heparin derivative coated stents to reduce clotting and restenosis, dental or ophthalmological implants. These materials may comprise additional polymeric compositions such as polyethyleneimine, dextran sulfate or their modified forms. These polymers together with heparin coatings may be applied to other substrate of medical devices such as metal, ceramics or biologically derived materials.