Prefilled Syringe Barrier Chamber for Sterilization Stability
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Solution Overview
Problem
Conventional prefilled containers with sterilization-sensitive materials, such as those used in medical kits, face issues like material alteration during sterilization, fragility, and high manufacturing costs due to the use of glass, and the inconvenience of separately packaging plastic containers to maintain sterility.
Innovation Solution
A prefilled syringe assembly with a barrel, plunger, and tip cap made from materials like cyclic olefin polymer, featuring a chamber that creates a barrier against sterilization gases, allowing for terminal sterilization without altering the contents, and a mechanical engagement system to prevent plunger expulsion during sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If glass containers are used for sterilization-sensitive materials, then the material composition stability is improved, but the device strength and safety deteriorate due to fragility and slivering
Solution Approach 1:
The patent changes the material parameter from glass to specific plastics (polypropylene, polyethylene, cyclic olefin copolymer) that can withstand sterilization processes. This material substitution maintains composition stability while eliminating fragility issues, allowing the container to survive autoclaving and EtO sterilization without breaking or slivering.
Solution Approach 2:
The patent employs composite construction with a plastic container body and an overwrap layer (aluminum foil, plastic film, or combination) to achieve both sterilization resistance and structural integrity. The overwrap provides additional strength and barrier properties while the plastic container maintains composition stability during sterilization.
2Strength
If plastic containers are used for sterilization-sensitive materials, then the device strength is improved, but the material composition stability deteriorates due to sterilization sensitivity
Solution Approach 1:
The patent applies preliminary protective actions by placing the plastic container with sterilization-sensitive material inside a sterilization-resistant overwrap (aluminum foil, plastic film) before sterilization. This pre-packaging protects the plastic container and its contents from direct exposure to harsh sterilization conditions, maintaining composition stability while allowing the use of durable plastic materials.
Solution Approach 2:
The overwrap acts as an intermediary barrier between the sterilization process (autoclave steam or EtO gas) and the plastic container contents. This intermediate layer protects the sterilization-sensitive material from direct contact with sterilization agents, enabling the use of plastic containers without compromising material stability.
3Stability of the object's composition
If prefilled containers are separately packaged to maintain sterility, then the material composition stability is improved, but the device complexity increases
Solution Approach 1:
The patent merges the prefilled container with sterilization-sensitive material and other sterilization-required components into a single sterilizable package. The entire assembly (container, overwrap, and accompanying surgical items) is sterilized together as one unit, eliminating separate packaging steps and reducing overall packaging complexity while maintaining sterility.
Solution Approach 2:
The sterilization-resistant overwrap serves multiple functions: it protects the plastic container from sterilization damage, maintains sterility of the contents, and allows the entire package to be sterilized together with other surgical kit components. This multi-functionality simplifies the overall packaging and sterilization process.
4Manufacturing precision
If glass containers are used for sterilization-sensitive materials, then the manufacturing precision is improved, but the productivity deteriorates due to handling time and breakage
Solution Approach 1:
The patent employs disposable plastic containers that can be sterilized and disposed of after use, eliminating the need for expensive glass containers that require careful handling and cleaning. The plastic containers are designed for single-use but can withstand sterilization, improving productivity by eliminating breakage-related delays and reducing handling time while maintaining adequate manufacturing precision.
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
Enables the sterilization of prefilled containers without altering the contents, reducing manufacturing complexity and costs, and maintaining sterility within medical kits, while allowing for convenient packaging with other surgical items.
Implementation Method 1
A chamber may be formed within the barrel between the plunger and tip cap and may be configured to hold materials such as sterilization sensitive materials
Implementation Method 2
a mechanical engagement system to prevent plunger expulsion during sterilization
Data Source
AI summary
A syringe assembly may include a plunger having a stopper. A barrel may be configured to receive the plunger at an open first end. A tip cap may be removably attached to the second end and may form a chamber within the barrel between the plunger and tip cap. The chamber may be configured to contain a sterilization sensitive material. The barrel may be formed of a plastic material having a high barrier property configured to create a barrier between the sterilization sensitive material and gases produced for sterilization purposes such that the sterilization sensitive material remains unchanged during a sterilization procedure.