Pressure Equalizing Device for Drug Reconstitution
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Solution Overview
Problem
Existing pressure equalizing devices for drug reconstitution are bulky, prone to clogging, and difficult to use in limited spaces due to their design, which can lead to contamination risks and instability during reconstitution processes.
Innovation Solution
A compact pressure equalizing device with a container having two chambers and a fluid transfer member with a vent channel, allowing direct fluid communication and alignment with the receptacle and injector, reducing the risk of aerosolization and contamination while preventing top-heaviness and instability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a pressure equalizing device is attached between the vial and fluid container during reconstitution, then the risk of fluid release and contamination is reduced, but the device takes up valuable space around the vial opening and may cause top-heaviness
Solution Approach 1:
The pressure equalizing device is nested within the receptacle structure, with the pressure equalizing chamber positioned inside the receptacle body. This nesting approach allows the device to maintain its pressure equalization function while occupying minimal external space, eliminating the top-heaviness problem described in the background.
Solution Approach 2:
The pressure equalizing chamber is arranged with its longitudinal axis collinear with the receptacle's longitudinal axis, utilizing the vertical dimension efficiently. This dimensional arrangement allows the device to function within the existing spatial envelope of the receptacle without protruding outward, thus avoiding space occupation issues.
2Reliability
If a hydrophobic filter is disposed in the port between the vial and pressure equalizing device, then fluid entry into the pressure equalizing chamber is prevented, but solid particles may clog the filter and hinder pressure equalization
Solution Approach 1:
The hydrophobic filter is extracted from the direct fluid path between the vial and pressure equalizing chamber. Instead of placing the filter in the port where it would be exposed to solid particles, the design allows direct communication while maintaining fluid containment through the chamber configuration and fluid dynamics, eliminating the clogging risk.
Solution Approach 2:
The pressure equalizing chamber itself acts as an intermediary structure that enables pressure equalization without requiring a filter in the direct fluid path. The chamber's design allows pressure transmission while preventing fluid entry through geometric constraints and pressure differential management, rather than relying on filter media.
3Reliability
If the pressure equalizing chamber longitudinal axis is arranged at a 90 degree angle relative to the vial longitudinal axis, then pressure equalization can be achieved, but the device becomes difficult to use in locations having limited space
Solution Approach 1:
The pressure equalizing device employs an asymmetric internal configuration where the pressure equalizing chamber is positioned and oriented to align with the receptacle's longitudinal axis rather than being perpendicular. This asymmetric arrangement optimizes the device for vertical integration, enabling efficient use of limited clinical space while maintaining pressure equalization functionality.
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 creates a closed system for safe reconstitution, reduces the risk of fluid release, and is more space-efficient, allowing easier use in clinical settings with reduced risk of contamination and improved stability.
Implementation Method 1
a vent channel establishing direct fluid communication between the first chamber and the receptacle when the receptacle is connected to the pressure equalizing device
Implementation Method 2
The pressure equalizing device comprises a gas container in communication with the interior of the vial, which ensures that neither an increased pressure nor a vacuum can occur inside the vial
Data Source
AI summary
Provided is a pressure equalizing device for facilitating drug reconstitution in a closed system. The pressure equalizing device includes a container for attachment to a receptacle, to permit pressure equalization between the container and the receptacle. The container includes a first chamber and a second chamber. The device further includes a vent channel extending between the first chamber and a distal opening of the vent channel. In accordance with the invention, when the receptacle is connected to the pressure equalizing device, the vent channel establishes direct fluid communication between the first chamber and the receptacle. Additionally, a longitudinal axis of the pressure equalizing device is configured to be aligned with or parallel to a longitudinal axis of the receptacle when the pressure equalizing device is attached to the receptacle.