Closed Fluid Transfer Adapter With Pressure-Equalizing Vent Filtration
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Solution Overview
Problem
Healthcare providers are at risk of exposure to hazardous drugs during reconstitution, transportation, and administration due to unintentional release of drugs into the atmosphere during the transfer process, particularly when differential pressure exists between the vial and the surrounding atmosphere.
Innovation Solution
A vial access device with an outer and inner housing, a pressure equalization system using a toroidal balloon, and a filter system to ensure leak-proof sealing and pressure equalization during the transfer of substances, accommodating vials of different sizes and preventing exposure to toxic drugs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to transfer solvent to a sealed vial, then fluid transfer can be achieved, but differential pressure between the vial interior and atmosphere can cause drug release into the atmosphere
Solution Approach 1:
The patent introduces a filter needle as an intermediary component between the vial interior and the syringe. The filter needle includes a filter element that traps aerosolized drugs while allowing solvent passage, and a vent port that equalizes pressure without exposing drugs to the atmosphere. This intermediary device enables safe fluid transfer while preventing the harmful release of drugs into the environment.
Solution Approach 2:
The patent creates a protected environment by filtering the vented air through a hydrophobic filter element that prevents drug aerosol escape. The system maintains a controlled atmosphere around the vial opening, allowing pressure equalization while keeping the drug-containing environment isolated from the external atmosphere, thus preventing exposure to healthcare providers.
2Object-affected harmful factors
If the vial is sealed to prevent drug release, then drug exposure is reduced, but pressure equalization becomes difficult during needle insertion and removal
Solution Approach 1:
The filter needle acts as a mediator that simultaneously provides both sealing and pressure equalization functions. The vent port in the filter needle allows pressure to equalize between the vial interior and atmosphere during needle insertion and removal, while the filter element ensures this pressure equalization occurs without releasing drugs into the atmosphere. This resolves the contradiction by enabling both sealed transfer and pressure equalization through a single integrated component.
3Object-affected harmful factors
If a filter is added to prevent drug release, then drug exposure is minimized, but the device complexity increases
Solution Approach 1:
The patent combines multiple functions into a single filter needle component: fluid transfer, filtration, and pressure equalization. By integrating the filter element, vent port, and needle structure into one unified device, the system prevents drug exposure without significantly increasing overall device complexity. The filter needle replaces what would otherwise require multiple separate components, thus merging functions to minimize complexity while achieving the desired safety outcomes.
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 provides leak-proof sealing and pressure equalization, minimizing the risk of drug exposure to healthcare personnel by preventing leakage and maintaining a sealed environment during the transfer process.
Implementation Method 1
a pressure equalization system configured to change a volume of space defined by the balloon and the outer housing
Implementation Method 2
A filter is positioned in the filter space
Data Source
Figure 1
Figure 2~3
Figure 4A
AI summary
A vial access device includes an outer housing defining an annular space and an inner space, an inner housing, and a connector configured to engage a mating connector with the connector having a body defining a central passageway and a flange that extends radially outward from the body. The flange and the housing defining a filter space that is in fluid communication with the annular space. A pressure equalization system is positioned within the annular space of the outer housing. The device also includes a vial connection element configured to be secured to a vial and having a body and a spike member extending from the body. The spike member defining a fluid passageway and a vent passageway with the fluid passageway in fluid communication with the central passageway of the connector and the vent passageway in fluid communication with the filter space and the annular space.