Injector Stopper Barrier with Activatable Laser Layer
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Solution Overview
Problem
Forming a durable seal in injector devices without using silicone or other lubricious materials is challenging due to defects such as wrinkles and scratches that can occur during manufacturing or insertion, which affect the sealing integrity and lead to leakage.
Innovation Solution
A stopper with an elastomer body and a multi-layer barrier that includes a first layer activatable by an energy source, such as a laser, to form micro features like micro grooves and ribs, enhancing sealing by concentrating sealing forces and reducing defects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a barrier layer is used to form a seal in the stopper, then sealing integrity is improved, but defects such as wrinkles and scratches occur during manufacturing or insertion that compromise the seal
Solution Approach 1:
The patent applies preliminary action by forming micro features (protrusions and recesses) on the sealing surface of the stopper before insertion into the barrel. These micro features are created through a multi-step process involving compression molding, laser treatment, and chemical etching, which prepare the sealing surface in advance to accommodate and mask defects that may occur during subsequent manufacturing or insertion operations.
Solution Approach 2:
The patent implements local quality by creating non-uniform micro features at specific locations on the sealing surface. The sealing surface includes an array of micro protrusions and recesses with varying depths and dimensions, concentrated in the sealing zone where they locally enhance sealing capability by distributing contact pressure and accommodating surface irregularities.
2Reliability
If silicone or lubricious materials are used to fill defects in the barrier, then sealing durability is improved, but contamination of pharmaceutical compositions occurs
Solution Approach 1:
The patent applies the extraction principle by completely removing silicone and other lubricious materials from the sealing system. Instead of using these materials to fill defects, the invention creates a defect-tolerant sealing surface through micro features that mechanically accommodate irregularities without requiring contaminating substances.
Solution Approach 2:
The patent converts the harmful effect of surface defects into a beneficial feature by designing micro protrusions and recesses that deliberately create controlled irregularities on the sealing surface. These micro features mask the effects of manufacturing defects and insertion damage, transforming potential failure points into reliable sealing zones.
3Reliability
If micro features are added to the sealing area to reduce defects, then sealing performance is improved, but device complexity increases
Solution Approach 1:
The patent applies parameter changes by modifying the surface topology of the stopper sealing area through controlled variations in height, depth, and distribution of micro features. The sealing surface includes micro protrusions with heights of 1-10 micrometers and recesses with depths of 5-20 micrometers, created through laser treatment and chemical etching parameters that optimize sealing performance without excessive complexity.
Solution Approach 2:
The patent replaces complex mechanical defect-filling mechanisms (such as silicone deformation and flow) with a static micro-structured surface that passively accommodates defects through its geometry. The micro features create a compliant sealing interface through their physical structure rather than requiring active material flow or deformation.
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 micro features improve sealing efficiency by reducing wrinkles and leakage, ensuring a reliable seal without the need for silicone or other lubricants, thus maintaining the integrity of pharmaceutical compositions within the injector device.
Implementation Method 1
a first layer of a first material and a second layer of a second material, the first layer being configured to be activatable by an energy source
Implementation Method 2
the first layer being configured to be activatable by an energy source
Implementation Method 3
a vibrational energy source such as an ultrasonic energy source
Data Source
AI summary
A stopper for use in an injector device, the stopper having an outer side configured for engagement with an interior bore of an injector device barrel, includes an elastomer body and a barrier coupled to the elastomer body, the barrier having an inner surface oriented toward the elastomer body and an outer surface oriented away from the elastomer body, the barrier including a first layer of a first material and a second layer of a second material, the first layer being configured to be activatable by an energy source and the second layer configured to be less activatable by the energy source than the first layer.