Vial Pressure Equalizing Device with One-Way Valve and Filter

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Solution Overview

Problem

During drug preparation, pressure differentials between vials and the atmosphere can lead to the unintended release of toxic substances into the air, as drugs are dissolved or diluted, posing risks to personnel handling these substances.

Innovation Solution

A pressure equalizing device with a fluid container and one-way valve system is attached to vials, allowing filtered fluid to flow between the container and the vial to equalize pressure, minimizing the risk of substance release and contamination, featuring a filter-receiving means to ensure cleanliness and a flexible gas container for volume adjustment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If safety boxes or isolators are used to prepare drugs, then the risk of toxic substances leaking into breathable air is reduced, but the space requirement increases and portability is lost

Engineering Contradiction:
Improverisk of toxic substances leakingVSAvoidspace requirement
Core Design Contradiction:
Object-affected harmful factorsVSArea of stationary object

Solution Approach 1:

The invention extracts the pressure equalization function from large fixed safety infrastructure and implements it through a portable device attached directly to the vial. The pressure equalizing device with one-way valve and filter-receiving means provides containment functionality at the point of use, eliminating the need for large safety boxes or isolators.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The pressure equalizing device acts as an intermediary between the vial interior and the external environment. It mediates pressure changes during drug preparation while maintaining containment through its one-way valve and filter system, allowing pressure equalization without direct exposure to toxic substances.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If a needle is used to transfer solvent into a sealed vial, then drug dissolution is achieved, but pressure differentials may cause unintended release of toxic substances into the air

Engineering Contradiction:
Improvedrug preparation efficiencyVSAvoidrelease of toxic substances
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The pressure equalizing device is attached to the vial before needle insertion and solvent transfer. This preliminary setup ensures that pressure equalization pathways are already in place, preventing pressure differentials that could cause toxic substance release during the subsequent drug preparation process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The pressure equalizing device serves as an intermediary pressure management system between the solvent transfer operation and the vial interior. It absorbs pressure changes during needle insertion and solvent addition, preventing backflow or aerosolization of toxic substances while allowing efficient drug preparation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If the gas container is filled with ambient air, then filling is simple, but airborne particles such as dust, pollen, mould or bacteria may contaminate the vial contents

Engineering Contradiction:
Improvefilling simplicityVSAvoidcontamination with airborne particles
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The filter-receiving means acts as an intermediary between ambient air and the sterile vial interior. It allows simple filling with ambient air while simultaneously filtering out airborne particles such as dust, pollen, mould, and bacteria, preventing contamination of the drug preparation environment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The filter-receiving means employs porous filtering material that allows gas passage while blocking airborne particles. This enables the gas container to be filled with ambient air in a simple manner while the porous filter prevents contamination of the vial contents with dust, pollen, mould, or bacteria.

Inventive Principle:
Principle #31Porous materials

4Object-affected harmful factors

If pressure equalization is implemented during drug preparation, then the risk of substance release is minimized, but device complexity increases

Engineering Contradiction:
Improverisk of substance releaseVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The pressure equalizing device is segmented into distinct functional components: a gas container for pressure management, a one-way valve for controlled fluid flow, and filter-receiving means for contamination prevention. This segmentation allows each component to perform its specific function while keeping the overall device design manageable and understandable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The pressure equalizing device combines multiple functions into a single integrated unit: pressure equalization, fluid flow control through one-way valve, and contamination filtration. This multi-functionality reduces the need for separate devices while minimizing substance release risk during drug preparation.

Inventive Principle:
Principle #6Universality (Multi-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 safe and reliable system for injecting or withdrawing substances while preventing contamination of breathable air, reducing the risk of aerosolization and maintaining vial integrity by equalizing pressure and filtering out airborne particles.

Implementation Method 1

a fluid inlet (20) that contains a one-way valve (28) that permits fluid to flow into the fluid container (16) via said fluid inlet (20) and that prevents fluid from flowing out of the fluid container (16) via said fluid inlet (20)

Methodology Applied
Scientific EffectOne-way valve: Valve

Implementation Method 2

The filter may be a sterilizing or aseptisizing filter, such as a particulate air filter, such as a high efficiency particulate air (HEPA) filter to remove gas-borne particles such as dust, pollen, mould or bacteria

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 3

The pressure equalizing device equalizes pressure in the fluid container and the receptacle by allowing filtered fluid to flow into or out of the receptacle (depending on whether the pressure is temporarily greater in the fluid container or the receptacle)

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentUS8029747B2Pressure equalizing device, receptacle and method
Publication Date: 2011.10.04 CARMEL PHARMA
  • US8029747B2 patent drawing
  • US8029747B2 patent drawing
  • US8029747B2 patent drawing

AI summary

Pressure equalizing device comprising a fluid container for attachment to a receptacle such as a vial to permit pressure equalization between the fluid container and the receptacle. The pressure equalizing device comprises a flow channel that is arranged to provide fluid communication into or out of the fluid container when the pressure equalizing device is attached to the receptacle. The pressure equalizing device also comprises a fluid inlet that contains a one-way valve that permits fluid to flow into the fluid container via said fluid inlet and that prevents fluid from flowing out of the fluid container via said fluid inlet and filter-receiving means that are arranged to permit fluid flowing into or out of the fluid container to be filtered when the filter-receiving means comprises a filter.