Closure With Breakable Wall And Hollow Piston For Sterile Mixing
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Solution Overview
Problem
Current methods for storing and recombining dry active biological agents with liquid diluents are prone to contamination and require complex, non-mechanizable processes, limiting their use to sterile environments and increasing waste due to the need for two containers and syringes.
Innovation Solution
A closure system with a sealed chamber and a hollow piston that can be manually slid to break through a breakable wall, allowing controlled recombination of active agents with diluents while maintaining sterility and preventing contamination, and a method for manufacturing pre-loaded containers suitable for large-scale production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If active agents and diluent are stored in separate containers and recombined before use, then contamination risk is increased, but storage stability is improved
Solution Approach 1:
The patent combines the storage of active agents and diluent into a single container system, where the active agent is stored in a sealed chamber and the diluent is stored in the main container body. This merging eliminates the need for separate containers while maintaining the stability benefits of separate storage until recombination.
Solution Approach 2:
The container is segmented into distinct compartments: a sealed chamber for the active agent and the main container body for the diluent. This segmentation allows both substances to be stored separately within the same container, maintaining stability while enabling controlled recombination without external syringes or sterile environments.
2Object-affected harmful factors
If frangible seal is used to separate active agents and diluent, then contamination risk is reduced, but the seal may break during transport or handling
Solution Approach 1:
The seal mechanism is designed to be dynamic rather than static. The plunger can be manually actuated to break the frangible seal when needed, transforming the seal from a passive barrier to an actively controlled release mechanism. This maintains seal integrity during transport while enabling reliable breakdown for recombination.
Solution Approach 2:
The frangible seal acts as an intermediary element between the sealed chamber and the main container. It provides a controlled interface that can be deliberately broken to allow mixing, while maintaining separation during storage and transport. The seal mediates between the need for separation and the need for controlled combination.
3Reliability
If syringe is required to extract recombined contents, then sterile environment is maintained, but device complexity and waste increase
Solution Approach 1:
The container system is designed to be self-sufficient for the entire recombination and dispensing process. The plunger mechanism allows the user to directly dispense the recombined mixture without requiring external syringes or needles. The system serves itself by integrating the dispensing function into the container closure, eliminating the need for additional sterile equipment.
Solution Approach 2:
The closure assembly serves multiple functions: it seals the container during storage, enables recombination by breaking the frangible seal, and provides dispensing capability through the plunger mechanism. This multi-functionality eliminates the need for separate syringes and needles, reducing device complexity while maintaining sterility through the integrated design.
4Reliability
If two containers and two sets of packaging are used for active agents and diluent, then storage stability is improved, but waste increases
Solution Approach 1:
The patent merges two separate packaging systems into a single integrated container. The active agent chamber and diluent container are combined into one unit, eliminating the need for two separate containers and their respective packaging materials. This reduces packaging waste while maintaining the stability benefits of separate storage compartments.
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 provides a safer, more efficient, and environmentally friendly method for storing and recombining active agents and diluents, allowing for use in non-sterile environments without the need for syringes and reducing waste by integrating the recombination process into a single container system.
Implementation Method 1
a hollow piston slidably mounted in a piston guide, said hollow piston comprising an outer wall, said outer wall having an end in the chamber and at least one ventilation aperture, said end having a cutting formation, said hollow piston being slidable in the piston guide between a ventilation position in which the at least one ventilation aperture allows ventilation of the chamber and a sealed position in which the at least one ventilation aperture is sealed to prevent ventilation of the chamber and a deployed position in which the cutting formation has broken through at least a portion of the breakable wall
Implementation Method 2
a closure for dispensing one or more active agents into a container, the closure comprising: a sealed or sealable chamber having a breakable wall
Data Source
AI summary
A closure for dispensing one or more active agents into a container comprises a sealed or sealable chamber having a breakable wall and a hollow piston slidably mounted in a piston guide. Said hollow piston comprises an outer wall having an end in the chamber and at least one ventilation aperture. Said end has a cutting formation. Said hollow piston is slidable in the piston guide between a ventilation position in which the at least one ventilation aperture allows ventilation of the chamber and a sealed position in which the at least one ventilation aperture is sealed to prevent ventilation of the chamber and a deployed position in which the cutting formation has broken through at least a portion of the breakable wall. The outer wall has a retaining formation which engages with the piston guide to releasably resist sliding of the hollow piston between the ventilation position and the sealed position and the deployed position. The hollow piston may have an outer wall, and said outer wall has an end within the chamber, facing the breakable wall, wherein the cutting end has a first edge having a cutting formation and a gap in said cutting formation.