Lubricant-Free Syringe Stopper Insertion via Vacuum Assistance

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Solution Overview

Problem

Conventional syringe technologies for pre-filled injection devices face challenges due to the use of silicone lubricants, which can contaminate drugs, cause protein aggregation, and lead to stopper damage if not applied properly, especially in biopharmaceutical applications.

Innovation Solution

A method for inserting a lubricant-free stopper into a lubricant-free barrel using a hybrid insertion device with a vacuum-assisted system, where the stopper is covered with a polymer layer and inserted through a conduit with a vacuum chamber to minimize contamination and damage, allowing for precise placement without lubricants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If silicone lubricant is used to ensure proper stopper insertion and sealing, then the ease of operation is improved, but the risk of drug contamination and protein aggregation increases

Engineering Contradiction:

Improvestopper insertion easeVSAvoiddrug contamination

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent removes silicone lubricant from the system entirely, extracting the harmful substance while maintaining the functional benefits through alternative means (vacuum-assisted insertion, polymer coating on stopper, and precision engineering of insertion surfaces)

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a polymer coating on the stopper as an intermediary substance that provides the necessary lubrication and sealing properties without using silicone, thereby mediating between the stopper and drug solution to prevent contamination

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If silicone lubricant is applied to facilitate stopper insertion, then the reliability of insertion is improved, but the risk of stopper damage from asperities increases when lubricant is omitted

Engineering Contradiction:

Improveinsertion reliabilityVSAvoidstopper damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the chemical lubrication mechanism with a vacuum-assisted mechanical insertion system, using vacuum force to guide the stopper through the insertion tube and barrel, thereby achieving reliable insertion without relying on silicone lubricant to bridge mechanical asperities

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If a vacuum-assisted insertion system is used to minimize stopper contact with the barrel, then the purity of the drug solution is improved, but the device complexity increases

Engineering Contradiction:

Improvedrug contaminationVSAvoidinsertion system complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent employs a nested structure where the insertion tube is positioned within the vacuum chamber, and the stopper is inserted through the insertion tube which itself is within the vacuum environment. This nested arrangement allows vacuum assistance to protect the stopper and drug solution from contamination while integrating multiple functions in a compact configuration

Inventive Principle:

Principle #7Nested doll (Nesting)

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 reduces the risk of drug contamination and stopper damage, ensuring reliable and safe delivery of therapeutic substances by eliminating the need for silicone lubricants and minimizing contact with the inner barrel surface.

Implementation Method 1

applying a vacuum through a vacuum port fluidly connected to a vacuum gap where the vacuum port is located at a distal end of a vacuum chamber portion of the hybrid insertion device

Methodology Applied

Scientific EffectVacuum: Vacuum

Data Source

PatentUS20230201467A1A method of inserting a lubricant free stopper into a lubricant free barrel or a lubricant free cartridge tube and a system for assembling same

Publication Date: 2023.06.29 WL GORE & ASSOC INC

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 of a hybrid insertion device, (2) lowering the body of the hybrid insertion device into a syringe barrel or cartridge tube to a position located past the barrel flange or top of the cartridge tube while stablishing a sealable connection with the syringe barrel or cartridge tube, (3) maneuvering the stopper past the distal opening of the hybrid insertion device using an insertion pin and deploying the stopper at a final position within the syringe barrel or cartridge tube under vacuum assistance, (4) fully retracting the insertion pin from the syringe barrel or cartridge tube, and (5) retracting the hybrid insertion device from syringe barrel or cartridge tube. The method is lubricant free or substantially lubricant free. The hybrid insertion device may be electropolished and/or extrude honed.