Pressure-Regulating Vial Adaptors for Filtered Pressure Equalization

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Solution Overview

Problem

Existing systems for extracting medicinal fluids from vials face issues with pressure differentials leading to fluid leakage, inaccurate withdrawal, and contamination risks due to airborne pathogens in ambient air used to equalize pressure.

Innovation Solution

A pressure-regulating vial adaptor with a regulator enclosure that expands or contracts to equilibrate pressure, incorporating a hydrophobic filter and a flexible regulator channel to manage fluid withdrawal and introduction, minimizing leakage and contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If ambient air is used to equalize pressure within vials, then pressure equilibrium is achieved, but contamination from airborne pathogens occurs

Engineering Contradiction:
Improvepressure equilibriumVSAvoidcontamination from airborne pathogens
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a regulator assembly as an intermediary component between the vial and the external environment. This regulator assembly includes a filter element that mediates the pressure equalization process by allowing pressure balance while blocking airborne pathogens, thus resolving the contradiction between achieving pressure equilibrium and preventing contamination.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a controlled internal environment within the regulator enclosure that acts as a protective barrier. By maintaining a sealed environment with controlled atmosphere inside the regulator enclosure, the system prevents harmful airborne contaminants from reaching the vial contents while still allowing pressure equalization through the filter.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Stability of the object's composition

If rigid housing is used to contain regulator enclosure, then structural stability is improved, but flexibility to expand and contract is reduced

Engineering Contradiction:
Improvestructural stabilityVSAvoidflexibility to expand and contract
Core Design Contradiction:
Stability of the object's compositionVSDuration of action of moving object

Solution Approach 1:

The patent divides the housing into two distinct segments: a rigid outer housing that provides structural stability and containment, and a separate flexible regulator enclosure that can expand and contract. This segmentation allows each component to fulfill its specific function independently, resolving the contradiction between structural stability and flexibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a flexible regulator enclosure that can deform to accommodate volume changes, while the rigid housing provides external structural support. The flexible enclosure acts as a thin film or shell within the rigid housing, allowing the system to maintain both structural stability and the ability to expand/contract as needed.

Inventive Principle:
Principle #30Flexible shells and thin films

3Strength

If regulator enclosure is placed within rigid housing, then protection from external damage is improved, but volume for regulator fluid is reduced

Engineering Contradiction:
Improveprotection from external damageVSAvoidvolume for regulator fluid
Core Design Contradiction:
StrengthVSVolume of moving object

Solution Approach 1:

The patent segments the internal volume by placing the regulator enclosure as a separate, flexible chamber within the rigid housing. This segmentation allows the regulator enclosure to be positioned to optimize both protection and available volume, ensuring sufficient space for regulator fluid while maintaining structural integrity through the rigid housing.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses a flexible regulator enclosure that can dynamically adjust its volume within the rigid housing. This dynamic flexibility allows the enclosure to maximize its internal volume for regulator fluid storage while still being protected by the rigid housing from external damage, resolving the contradiction between protection and volume.

Inventive Principle:
Principle #15Dynamics

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 effectively regulates pressure within vials, ensuring accurate fluid withdrawal and reducing contamination risks by maintaining pressure equilibrium and preventing the introduction of harmful substances.

Implementation Method 1

a regulator enclosure configured to expand or contract to equilibrate pressure

Methodology Applied
Scientific EffectPressure equalization: Pascal's Law

Implementation Method 2

The filter can be configured to permit regulator fluid to flow between the regulator enclosure and the vial

Methodology Applied
Scientific EffectHydrophobic filtration: Hydrophobe

Data Source

PatentUS20250318994A1Pressure-regulating VIAL adaptors
Publication Date: 2025.10.16 ICU MEDICAL INC
  • US20250318994A1 patent drawing
  • US20250318994A1 patent drawing
  • US20250318994A1 patent drawing

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