Lubricant-Free Stopper Insertion for Silicone-Free Syringe Barrels
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Solution Overview
Problem
Conventional syringe technology for pre-filled injection devices poses contamination risks due to the use of silicone lubricants, which can degrade or contaminate drugs and biologics, and causes damage to stoppers if lubricants are omitted, leading to potential failure.
Innovation Solution
A method and system for inserting a lubricant-free stopper into a lubricant-free barrel using an insertion tube and pin, with specific surface roughness and kurtosis, and a polymer-coated elastomeric body, ensuring the stopper is positioned without lubricants, minimizing contamination and damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If silicone lubricant is used in conventional syringes, then the force required to actuate the syringe is minimized, but the drug or biologic may be degraded or contaminated
Solution Approach 1:
The patent removes the silicone lubricant from the syringe system entirely, extracting the harmful element while maintaining the functional requirement for low-friction operation through alternative means (smooth barrel interior surface design)
Solution Approach 2:
The patent introduces an intermediary mechanism (modified barrel interior surface with controlled surface roughness and hydrophobic properties) that mediates the interaction between the stopper and barrel, enabling smooth operation without requiring silicone lubricant
2Strength
If silicone lubricant is used during stopper insertion, then the stopper can pass over asperities without damage, but the lubricant may be injected into the patient along with the drug
Solution Approach 1:
The patent eliminates the silicone lubricant that could be injected into the patient, removing the source of contamination while maintaining stopper integrity through alternative surface design
3Ease of operation
If silicone lubricant is applied to the insertion tube, then the stopper insertion is facilitated, but the lubricant may contaminate the drug or biologic
Solution Approach 1:
The patent removes the silicone lubricant from the insertion tube, extracting the contaminant while maintaining insertion ease through controlled surface roughness and hydrophobic properties of the barrel interior
4Object-affected harmful factors
If the barrel interior surface is made smooth to prevent contamination, then drug purity is improved, but the stopper insertion may be difficult
Solution Approach 1:
The patent optimizes the surface roughness parameter of the barrel interior to a specific range (Ra 0.05-0.2 μm) that balances smoothness for contamination prevention with sufficient friction control for easy stopper insertion
Data Source
AI summary
A method of inserting a lubricant free stopper into a lubricant free syringe barrel or lubricant free cartridge tube is disclosed. The method includes (1) inserting a stopper with a sealing rib into a placement region, (2) lowering the body of the insertion tube into a syringe barrel or cartridge tube to a position located past the barrel flange or top of the cartridge tube, (3) maneuvering the stopper to a distal opening of the insertion tube using an insertion pin, (4) retracting the insertion tube while the stopper remains in a fixed position within the syringe barrel or cartridge tube, and (5) fully retracting the insertion pin and the insertion tube from the syringe barrel or cartridge tube. The method is lubricant free or substantially lubricant free. The insertion tube may be electropolished and/or extrude honed.