Flexible-Regulator Vial Adaptors for Pressure-Balanced Fluid Withdrawal
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Solution Overview
Problem
Existing systems for extracting medicinal fluids from vials face issues such as pressure differentials leading to fluid leakage, inaccurate fluid withdrawal, and contamination risks due to exposure to ambient air, particularly with volatile and hazardous drugs.
Innovation Solution
A pressure-regulating vial adaptor with a flexible regulator enclosure that expands or contracts to maintain pressure equilibrium, incorporating a hydrophobic filter and a regulator channel to control fluid flow, ensuring accurate withdrawal and minimizing contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If fluid is withdrawn from a sealed vial, then fluid extraction is achieved, but pressure differential causes fluid leakage and contamination
Solution Approach 1:
A regulator fluid acts as an intermediary substance introduced into the vial to balance the pressure differential created during fluid withdrawal. This mediator prevents harmful effects by equalizing pressure between the vial interior and exterior, eliminating the driving force for leakage and contamination
Solution Approach 2:
The system maintains a controlled, sterile environment within the vial during fluid withdrawal. By introducing regulator fluid through a controlled mechanism and using a hydrophobic filter, the system creates an inert protective atmosphere that prevents contamination from ambient air while enabling fluid extraction
2Object-affected harmful factors
If pressure is regulated during fluid withdrawal, then fluid leakage is prevented, but system complexity increases
Solution Approach 1:
The regulator enclosure is designed to automatically respond to pressure changes during fluid withdrawal. As fluid is removed from the vial, the regulator fluid independently expands to fill the created volume and maintain pressure equilibrium, without requiring external control mechanisms or complex regulation systems
Solution Approach 2:
The system utilizes changes in the physical state and volume of the regulator fluid to achieve pressure regulation. The regulator fluid transitions between different volume states in response to pressure differentials, automatically adjusting to maintain equilibrium without complex mechanical or electronic controls
3Stress or pressure
If regulator fluid is introduced into the vial, then pressure equilibrium is maintained, but risk of contamination increases
Solution Approach 1:
A hydrophobic filter serves as an intermediary barrier between the regulator fluid and the medicinal fluid in the vial. This filter allows pressure equalization through gas permeability while preventing liquid and contaminant passage, thus maintaining pressure equilibrium without compromising sterility
Solution Approach 2:
The hydrophobic filter utilizes a porous structure with specific pore size and surface properties that permit gas molecules to pass through for pressure equalization while blocking larger liquid droplets and particulate contaminants. This selective permeability enables pressure regulation while preventing contamination
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 adaptor maintains pressure equilibrium within the vial, preventing fluid leakage and contamination, enabling precise fluid withdrawal and reducing exposure to harmful substances.
Implementation Method 1
the regulator enclosure is configured to move between a first orientation, in which at least a portion of the regulator enclosure is at least partially expanded or unfolded, and a second orientation, in which at least a portion of the regulator enclosure is at least partially unexpanded or folded, when a fluid is withdrawn from the sealed vial via the extractor channel
Implementation Method 2
The adaptor can also include a hydrophobic filter in fluid communication with the regulator channel
Data Source
AI summary
In certain embodiments, a vial adaptor comprises a housing configured to couple the adaptor with a vial, an access channel, a regulator channel, and a regulator assembly. The access channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. The regulator channel is configured to facilitate a flow of a regulating fluid from the regulator assembly to compensate for changes in volume of a medical fluid in the vial. In some embodiments, the regulator assembly includes a flexible member configured to expand and contract in accordance with changes in the volume of the medical fluid in the vial. In some embodiments, the flexible member is substantially free to expand and contract. In some embodiments, the flexible member is not partly or completely located in a rigid enclosure.