Depyrogenated Chitosan Shards via Nitrogen Gamma-Irradiation
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Solution Overview
Problem
Conventional hemostatic agents, including chitosan-based materials, often contain pyrogens such as endotoxins that can induce septic responses when used in medical applications, limiting their applicability and requiring stringent endotoxin reduction for implantable medical devices.
Innovation Solution
A method involving the processing of chitosan into ultra-thin materials, such as shards or fibrids, followed by γ-irradiation under nitrogen and potentially nitrogen plasma treatment, to reduce or inactivate endotoxins, thereby creating a depyrogenated chitosan product suitable for internal medical use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional chitosan manufacturing methods are used, then production cost is low and manufacturing is easy, but endotoxin levels are high causing pyrogenic responses
Solution Approach 1:
The patent applies preliminary action by performing γ-irradiation treatment during the manufacturing process to depyrogenate chitosan before final product formation. This proactive approach removes endotoxins during production rather than attempting removal after manufacturing, thereby achieving low endotoxin levels without requiring complex post-manufacturing purification steps
Solution Approach 2:
The patent utilizes parameter changes by subjecting chitosan to γ-irradiation with specific energy levels (typically 25-50 kGy) to achieve depyrogenation. This physical treatment parameter change effectively reduces endotoxin levels while maintaining chitosan's structural integrity and hemostatic properties, resolving the contradiction between purity and manufacturing simplicity
2Object-affected harmful factors
If γ-irradiation treatment is applied to reduce endotoxins, then endotoxin levels decrease meeting FDA standards, but processing time and energy consumption increase
Solution Approach 1:
The patent optimizes the γ-irradiation energy parameters to achieve effective depyrogenation at moderate energy levels (25-50 kGy). By carefully selecting and controlling irradiation dose parameters, the process achieves endotoxin reduction meeting FDA standards while minimizing excessive energy consumption that would occur with higher doses
Solution Approach 2:
The patent replaces mechanical or chemical purification methods with γ-irradiation physical treatment. This substitution eliminates the need for multiple washing, filtration, or chemical treatment steps that would consume additional energy and time, making the overall process more energy-efficient while achieving the same depyrogenation goal
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 treatment effectively reduces endotoxin levels in chitosan materials to meet FDA standards, ensuring safety for implantable medical devices while maintaining the hemostatic and bioadhesive properties of chitosan.
Implementation Method 1
irradiating the ultra-thin chitosan material under nitrogen using γ-irradiation
Implementation Method 2
nitrogen plasma treatment
Data Source
AI summary
A thin chitosan-based material can be used for biomedical applications. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan material. A single or multiple such treatments may be employed. For example, the chitosan material may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. A thin chitosan material can be readily treated by surface modifying treatments such as irradiating under nitrogen using γ-irradiation, treating under a nitrogen plasma, or both.