Integrated Lyophilization Device with Gas-Permeable Membrane
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Solution Overview
Problem
Existing methods for containing, lyophilizing, reconstituting, and administering lyophilized substances often require separate closure adapters, elastically deformable containers, and multiple needle inserts, leading to complexity and inefficiency in the mixing and administration process.
Innovation Solution
A modular device with a single housing containing a first chamber for the lyophilizate and a second chamber for the diluent, where the lyophilizate is sealed with a removable closure and the diluent is connected via a gas-permeable membrane, allowing for sterile storage and easy reconstitution without exposing the substances to the environment, and featuring a plunger mechanism for controlled reconstitution and administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate closure adapters and multiple needle inserts are used, then sterility can be maintained, but device complexity increases
Solution Approach 1:
The patent combines the closure adapter and needle insert functions into a single integrated closure element. The closure element includes a closure cap that seals the first chamber and an integrated needle insert that pierces the closure cap to establish fluid communication. This merging eliminates the need for separate closure adapters and multiple needle inserts, reducing device complexity while maintaining sterility through the integrated design.
Solution Approach 2:
The closure element serves multiple functions: it seals the first chamber to maintain sterility, provides a mounting structure for the needle insert, and facilitates fluid communication when the needle insert pierces the closure cap. This multi-functional design replaces several separate components with a single universal element, reducing overall device complexity.
2Ease of operation
If elastically deformable containers are used, then reconstitution can be achieved, but manufacturing complexity increases
Solution Approach 1:
The patent divides the system into two separate chambers: a first chamber for containing the lyophilized substance and a second chamber for containing the injection fluid. Each chamber is sealed independently, allowing for simpler manufacturing of rigid containers rather than complex elastically deformable single containers. The segmentation enables independent manufacturing and assembly of each chamber.
Solution Approach 2:
The patent introduces a plunger as an intermediary mechanism to transfer the injection fluid from the second chamber to the first chamber. The plunger establishes fluid communication between chambers and forces the injection fluid into the first chamber to reconstitute the lyophilized substance, eliminating the need for elastically deformable containers while maintaining ease of reconstitution.
3Adaptability or versatility
If a two-part adapter design is used, then connection flexibility is improved, but operation time increases
Solution Approach 1:
The patent merges the adapter and closure cap into a single integrated closure element. The closure element includes a closure cap that seals the first chamber and integrates the needle insert functionality, eliminating the need for separate adapter components. This integration reduces the number of assembly steps and operation time while maintaining connection flexibility through the unified design.
4Reliability
If multiple separate components are used, then sterility can be maintained, but the number of devices increases
Solution Approach 1:
The patent combines multiple separate components (closure adapter, needle insert, mounting structure) into a single integrated closure element that performs all necessary functions. The closure element seals the first chamber, provides needle insert functionality, and establishes fluid communication, reducing the total number of devices from multiple separate components to a single integrated unit.
Solution Approach 2:
The closure element is designed as a universal component that performs multiple functions: sealing the chamber, providing needle insert mounting, enabling fluid communication, and facilitating reconstitution. This multi-functional design replaces several separate sterile components with a single universal element, reducing device count while maintaining sterility.
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 device ensures sterile storage and reconstitution of the lyophilized substance, reduces the number of required devices, and simplifies the administration process by allowing for sequential opening and connection of chambers, optimizing the mixing operation and maintaining sterility throughout.
Implementation Method 1
a second chamber in which a cartridge containing a diluent is disposed, wherein at least one opening connects the second chamber to the ambient atmosphere and is closed by a membrane which is permeable to gas but not to bacteria
Implementation Method 2
The plunger is then moved in the first chamber in the direction towards the front housing end so that the reconstituted substance is ejected out of the first chamber
Data Source
AI summary
The invention relates to a method and a device for lyophilizing, reconstituting and administering a reconstituted substance. The device has an elongate housing having a dispensing-side front housing end and a housing end lying opposite it. A first chamber, containing a lyophilizate, is disposed in the housing in the region of the front housing end and is tightly sealed at an end facing the front housing end by a removable closure and is tightly sealed in the direction of the rear housing end by a plunger. A second chamber is provided or formed in the housing in the region of the rear housing end which is connected by at least one opening to the ambient atmosphere. This opening is closed by a membrane which is permeable to gas but not to bacteria.