Syringe Primer Coating for Breakout Force Consistency

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Solution Overview

Problem

Glass pharmaceutical packages are prone to breakage and degradation, leading to glass particulates in drugs, and existing lubrication methods do not consistently provide low initiation and maintenance forces for plunger movement, especially between glass and plastic syringes, with surface energy differences affecting performance.

Innovation Solution

A syringe with a primer coating of SiOxCy applied by PECVD using octamethylenecyclotetrasiloxane or hexamethyldisiloxane as precursors, followed by a deposit of polydimethylsiloxane lubricant, which improves lubrication and reduces friction, allowing for a consistent breakout and maintenance force profile similar to glass syringes on plastic ones.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If glass is used for syringe manufacturing, then lubrication performance and consistent breakout force are improved, but glass is prone to breakage and degradation causing particulates in drugs

Engineering Contradiction:
Improvebreakage resistanceVSAvoidglass particulates
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies composite materials by combining plastic syringe material with a silicon-containing coating layer deposited on the interior surface. This composite structure provides the breakage resistance of plastic while the coating layer delivers the lubrication performance and consistency previously only achievable with glass, eliminating glass particulate contamination.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the surface parameters of the plastic syringe by depositing a silicon-containing coating layer with specific compositional characteristics. This modifies the surface energy and friction properties to achieve breakout force profiles similar to glass syringes, while maintaining the bulk material's resistance to breakage.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If silicone oil is applied as lubricant on plastic syringes, then lubrication is provided, but the breakout force profile differs from glass syringes due to surface energy differences

Engineering Contradiction:
Improvebreakout force consistencyVSAvoidperformance consistency between glass and plastic
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the surface parameters by depositing a silicon-containing coating layer with controlled composition on the plastic syringe interior. This modifies the surface energy to match glass-like properties, enabling consistent breakout force profiles and making plastic syringes perform reliably like glass syringes.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The silicon-containing coating layer acts as an intermediary between the plastic syringe material and the silicone oil lubricant. This intermediate layer ensures proper lubricant adhesion and distribution, creating a consistent breakout force profile that mimics glass syringe performance.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If glass syringes are used, then tight dimensional tolerances and consistent lubrication are achieved, but manufacturing complexity and cost increase

Engineering Contradiction:
Improvedimensional toleranceVSAvoidmanufacturing process complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent creates a composite structure with a plastic base material providing dimensional stability and a deposited silicon-containing coating layer providing precise surface properties. This combination achieves tight dimensional tolerances and consistent lubrication performance while using simpler, more cost-effective plastic manufacturing processes.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent replaces complex glass forming processes with a simpler plastic injection molding process followed by a deposition step. This substitution maintains manufacturing precision while reducing overall process complexity and cost.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 solution enhances the lubrication between sliding parts, improves fluid drainage, and allows for a similar breakout force profile on both glass and plastic syringes, reducing the risk of glass particulates and maintaining performance over time.

Implementation Method 1

The primer coating or layer has been deposited by PECVD using octamethylenecyclotetrasiloxane (OMCTS) or hexamethyldisiloxane (HMDSO) as precursor in the presence of oxygen

Methodology Applied
Scientific EffectPlasma enhanced chemical vapor deposition: Plasma Enhanced Chemical Vapour Deposition

Implementation Method 2

The deposit of fluid lubricant is deposited on the inside surface of the primer coating or layer. It comprises polydimethylsiloxane. The primer coating or layer improves the lubrication between the relatively sliding parts

Methodology Applied
Scientific EffectLubrication: Lubrication

Data Source

PatentEP2961858B1Coated syringe.
Publication Date: 2022.09.07 SIO2 MEDICAL PRODUCTS INC
  • EP2961858B1 patent drawingFigure 1
  • EP2961858B1 patent drawingFigure 2
  • EP2961858B1 patent drawingFigure 3

AI summary

A syringe comprising a wall having a generally cylindrical interior surface defining a lumen with a primer coating or layer between 1 and 1000 nm thick of SiOx Cy Hz, in which x is from about 0.5 to about 2.4, y is from about 0.6 to about 3, and z is from about 2 to about 9, on at least a portion of the interior surface, the primer coating or layer having an outside surface facing the interior surface of the barrel and an inside surface facing the lumen. A deposit of fluid lubricant on the inside surface of the primer coating or layer is further provided.