Vacuum Stopper Insertion for Lubricant-Free Syringe Assembly

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Conventional syringe technology for pre-filled injection devices poses contamination risks due to the use of silicone lubricants, which can degrade drugs or biologics and cause protein aggregation, and also results in stopper damage from barrel asperities when lubricants are absent.

Innovation Solution

A method involving vacuum insertion of a lubricant-free stopper with a polymer layer into a lubricant-free barrel or cartridge tube, using a vacuum chamber and insertion rod to minimize contamination and stopper damage, with optional pressure assistance.

Engineering Contradictions & Design Principles

VSEngineering 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 silicone may contaminate the drug or biologic and cause protein aggregation

Engineering Contradiction:

Improveforce required to actuate syringeVSAvoiddrug contamination and protein aggregation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent removes silicone lubricant from the syringe barrel inner surface, extracting the harmful substance that causes drug contamination while maintaining the necessary sealing and actuation functions through alternative means

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent modifies the surface properties of the barrel inner surface by applying a specific coating with controlled roughness parameters (Ra of 0.05-0.5 micrometers) to achieve both sealing capability and compatibility with biologics without silicone

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If silicone lubricant is applied to the syringe barrel, then the stopper can easily pass over manufacturing asperities, but the lubricant may be injected into the patient with the drug

Engineering Contradiction:

Improvestopper insertion easeVSAvoidpatient injection contamination

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent eliminates silicone lubricant from the system entirely, removing the source of patient contamination while maintaining stopper insertion functionality through optimized surface coatings and vacuum insertion techniques

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a specialized coating layer as an intermediary between the stopper and barrel surfaces, enabling smooth passage over asperities without requiring silicone lubricant that could contaminate the patient

Inventive Principle:

Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a non-lubricated stopper is inserted into a non-lubricated barrel, then contamination risk is reduced, but damage or destruction of the stopper may result from manufacturing asperities

Engineering Contradiction:

Improvedrug contamination riskVSAvoidstopper integrity and syringe functionality

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent optimizes the surface roughness parameters of the barrel coating (Ra of 0.05-0.5 micrometers) to create a surface that is smooth enough to protect the stopper from damage by manufacturing asperities while maintaining sealing capability without lubricant

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent applies a protective coating to the barrel inner surface beforehand that acts as a cushioning layer, absorbing the mechanical stress from manufacturing asperities before they can damage the stopper during insertion

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 method reduces drug contamination risks and minimizes stopper damage by ensuring a precise fit without lubricants, maintaining the integrity and safety of the syringe assembly.

Implementation Method 1

applying vacuum through a vacuum port fluidly connected to the non-lubricated barrel to translate the stopper through the vacuum chamber from the placement region of the vacuum chamber into a proximal end of the non-lubricated barrel

Methodology Applied

Scientific EffectVacuum: Vacuum

Data Source

PatentUS12629477B2Vacuum insertion methods for inserting lubricant free syringe stoppers and a system for assembling same

Publication Date: 2026.05.19 WL GORE & ASSOC INC

AI summary

Methods 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 vacuum chamber, (2) creating a seal between the vacuum chamber and a syringe barrel or a cartridge tube, (3) maneuvering the stopper into a proximal end of the syringe barrel or cartridge tube by a first differential pressure and/or an insertion rod, (4) maneuvering the stopper through the barrel by second differential pressure and/or an insertion rod, (5) optionally sealing a pressure sealing cap to the proximal end of the vacuum chamber, (6) removing the vacuum chamber, insertion rod, and, if present, the pressure sealing cap. The methods are lubricant free or substantially lubricant free. The vacuum chamber may be electropolished and/or extrude honed.