Amino-Modified Rubber Coating for Silicone-Oil-Free Syringe Seals
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Solution Overview
Problem
Existing slidable rubber materials used in medical syringes and injectors face issues such as silicone oil-induced aggregation of active ingredients, contamination risks, and leakage due to friction, especially with highly functionalized proteins and increased detection sensitivity, while lacking effective silicone oil-less alternatives that maintain slidability and sealing properties.
Innovation Solution
A slidable rubber material with an amino-modified interfacial modification layer and a coating layer containing solid fine particles and addition-type or condensation-type silicone rubber, which does not expose silicone oil on the surface, ensuring strong bonding and sealing without inhibiting curing, and incorporating a filler and vulcanization agents to enhance slidability and durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If silicone oil is applied to improve slidability, then friction is reduced and slidability is improved, but aggregation of active ingredients occurs and contamination risks increase
Solution Approach 1:
The patent extracts and removes silicone oil from the gasket surface while preserving its slidability function through an alternative coating system consisting of a fluoro-resin laminate layer and a silicone rubber coating layer with solid fine particles, thereby eliminating the harmful effects of silicone oil on medicinal solutions
Solution Approach 2:
The patent employs a composite coating structure comprising a fluoro-resin laminate layer and a silicone rubber coating layer containing solid fine particles, which combines the low-friction properties of fluoro-resin with the flexibility and sealing properties of silicone rubber, achieving excellent slidability without silicone oil
2Object-affected harmful factors
If fluoro-resin laminate layer is used to eliminate silicone oil, then contamination is avoided, but leakage occurs due to wrinkles caused by friction
Solution Approach 1:
The patent creates a composite structure where a fluoro-resin laminate layer is combined with a silicone rubber coating layer containing solid fine particles. The fluoro-resin layer provides low-friction properties to prevent wrinkles, while the silicone rubber layer maintains sealing performance, thus resolving the contradiction between avoiding contamination and maintaining reliability
Solution Approach 2:
The patent applies different materials with specific properties to different functional requirements: the fluoro-resin laminate layer is positioned to handle friction and prevent wrinkles, while the silicone rubber coating layer is positioned to provide sealing, creating local optimization of material properties throughout the gasket structure
3Ease of operation
If addition-type silicone rubber is used in coating layer, then slidability is improved, but curing is inhibited by nitrogen- or sulfur-containing compounds
Solution Approach 1:
The patent changes the chemical composition parameters of the silicone rubber by incorporating amino-modified silicone rubber, which has different reactivity characteristics that allow curing to proceed despite the presence of nitrogen-containing compounds, thus resolving the contradiction between maintaining slidability and enabling manufacturing
Solution Approach 2:
The patent introduces an amino-modified silicone rubber as an intermediary material that bridges the conflicting requirements: it provides the desired slidability properties while its modified chemical structure allows it to cure in the presence of nitrogen- or sulfur-containing compounds that would otherwise inhibit the curing 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
The material provides excellent slidability, durability, and liquid-sealing properties, reducing the risk of active ingredient aggregation and contamination, while maintaining high-quality medical performance and compliance with pharmaceutical standards, even under sterilization conditions.
Implementation Method 1
an interfacial modification layer which coats the rubber part and in which an amino-modified silicone compound as amino-modified silicone oil is incorporated and/or reacted with surface molecules of the rubber part
Implementation Method 2
a coating layer which coats the interfacial modification layer and contains solid fine particles having an average particle size of 0.01-30 μm, an addition-type and/or condensation-type silicone rubber in which the solid fine particles are dispersed
Implementation Method 3
a curing catalyst for the silicone rubber
Data Source
AI summary
Provided is a slidable rubber material that has an amino-modified interfacial layer that does not affect basic properties such as the compression set. Although the slidable rubber material comprises a rubber part made of a rubber component such as a butyl rubber or halogenated butyl rubber etc. having the low-compression set, which contains a vulcanization agent such as a nitrogen/sulfur compound or a vulcanizing auxiliary agent, the rubber part is tightly coated with a coating layer that contains a silicone rubber without inhibiting curing. The slidable rubber material exhibits an excellent slidability and resists the detachment or elution of fine particles from the coating layer. The slidable rubber material comprises a rubber part containing a rubber component such as butyl rubber etc., a filler, and a vulcanization agent; an interfacial modification layer that coats the rubber part and in which an amino-modified silicone compound is incorporated and/or reacted with surface molecules of the rubber part; and a coating layer that coats the interfacial modification layer and contains solid fine particles, an addition-type and/or condensation-type silicone rubber in which the solid fine particles are dispersed, and a curing catalyst for the silicone rubber.