Pre-filled Diluent Syringe Vial Adapter Venting
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Solution Overview
Problem
The existing methods for reconstituting freeze-dried drugs are cumbersome, prone to user error, and risk contamination due to the handling of multiple needles and the potential for incorrect needle usage, with no effective means to vent air pressure during diluent addition.
Innovation Solution
A vial adapter that includes a coupling member, a spike with conduits, and a penetrating cannula, which transitions between sealed and open states to facilitate the transfer of diluent from a prefilled syringe to a lyophilized drug vial, reducing the need for multiple needle handling and providing a secure, sterile connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional needle-based reconstitution method is used, then diluent can be transferred to vial, but multiple needle handling increases needle-stick risk and potential for user error
Solution Approach 1:
The adapter combines multiple functions into a single device: it integrates a spike for vial penetration, a coupling member for syringe attachment, and internal fluid pathways. This single integrated adapter replaces the traditional method requiring multiple separate needles, reducing needle-stick risks while maintaining the complete reconstitution functionality.
Solution Approach 2:
The adapter serves as an intermediary device between the syringe and vial. Instead of directly handling multiple needles to transfer diluent and withdraw reconstituted drug, the adapter mediates the connection, providing a secure interface that eliminates the need for repeated needle insertions and extractions.
2Reliability
If traditional method with multiple piercings is used, then diluent transfer is achieved, but needle becomes dulled and contaminated with particulate
Solution Approach 1:
The adapter is designed as a single-use disposable device. The spike penetrates the vial stopper once, and the coupling member attaches to the syringe once. This eliminates the repeated piercing and dulling of reusable needles, ensuring sterility and preventing particulate contamination from degraded needle surfaces.
3Quantity of substance
If vial is pressurized when diluent is added, then complete filling is achieved, but no means to vent air makes fine control difficult
Solution Approach 1:
The adapter incorporates a dynamic venting mechanism that automatically responds to pressure conditions. The vent allows air to escape during diluent addition when positive pressure exists, and automatically closes when negative pressure is applied during withdrawal, providing fine control without manual intervention.
4Ease of operation
If adapter includes vent conduit for pressure equalization, then fine control during withdrawal is improved, but device structure becomes more complex
Solution Approach 1:
The vent conduit serves multiple functions: it vents air during diluent addition, equalizes pressure during withdrawal, and automatically seals when negative pressure is applied. This multi-functionality is achieved within the existing adapter structure, minimizing additional complexity while maximizing operational control.
Data Source
AI summary
In some embodiments, an adapter comprises an adapter body comprising a coupling member configured for coupling with a pre-fillable assembly and a spike having at least one conduit extending from a central body. At least one conduit extends through the spike, adapter body and the coupling member. A spike cover is sized to receive and seal the spike, the cover reversibly securable to the central body and receiving members configured to receive a vial shroud.