Pressure-Regulating Vial Adaptor with Flexible Enclosure

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Solution Overview

Problem

Existing systems for accessing medicinal vials face challenges with pressure differentials, leading to fluid leakage, inaccurate withdrawals, and contamination risks due to the introduction of ambient air, which can contain harmful contaminants.

Innovation Solution

A medical adaptor with a regulator assembly that includes a flexible enclosure capable of expanding to maintain pressure equilibrium within the vial, using a filler to supply regulating fluid and prevent vapor release, and a filter to inhibit the ingress of contaminants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If fluid is withdrawn from a sealed vial using conventional adaptors, then fluid extraction is enabled, but pressure differentials cause fluid leaks and inaccurate withdrawal

Engineering Contradiction:

Improvefluid extraction capabilityVSAvoidfluid withdrawal accuracy

Core Design Contradiction:

ProductivityVSManufacturing precision

Solution Approach 1:

The regulator enclosure acts as an intermediary between the vial interior and exterior environment, introducing regulated air to equalize pressure differentials during fluid withdrawal, thereby preventing leaks and improving withdrawal accuracy

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system dynamically changes pressure parameters within the vial by introducing regulated air through the regulator assembly, maintaining pressure equilibrium that enables accurate fluid withdrawal without leaks

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If conventional adaptors are used to access sealed vials, then fluid access is achieved, but vapor release and contamination occur

Engineering Contradiction:

Improvevial access capabilityVSAvoidvapor release and contamination

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The regulator enclosure creates a controlled atmosphere that prevents harmful vapors and contaminants from escaping during vial access and fluid withdrawal operations

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The filter assembly acts as an intermediary barrier that allows fluid passage while blocking harmful vapors and contaminants, enabling safe vial access without exposure to dangerous substances

Inventive Principle:

Principle #24Intermediary (Mediator)

3Strength

If a rigid enclosure is used for the regulator assembly, then structural stability is provided, but the device becomes bulky and difficult to handle

Engineering Contradiction:

Improvestructural stabilityVSAvoiddevice size and portability

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The regulator enclosure is made flexible rather than rigid, allowing the device to maintain structural integrity while being compact and easy to handle during medical procedures

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The flexible regulator enclosure can dynamically expand and contract to accommodate pressure changes and fluid volume variations, providing both stability and compactness

Inventive Principle:

Principle #15Dynamics

4Device complexity

If the regulator enclosure is kept compact, then device portability is improved, but sufficient regulator fluid volume cannot be maintained

Engineering Contradiction:

Improvedevice compactnessVSAvoidregulator fluid volume

Core Design Contradiction:

Device complexityVSQuantity of substance

Solution Approach 1:

The flexible regulator enclosure can expand to provide sufficient regulator fluid volume while maintaining a compact form factor when not in use, solving the contradiction between portability and fluid capacity

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The flexible enclosure can be nested or folded into a compact configuration for storage and transport, then expanded to full volume when regulator fluid is needed

Inventive Principle:

Principle #7Nested doll (Nesting)

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 solution allows for accurate and safe withdrawal and injection of fluids without significant pressure changes, reducing the risk of contamination and leakage, while maintaining a sterile environment by regulating pressure and filtering out harmful substances.

Implementation Method 1

capable of expanding to maintain pressure equilibrium within the vial by introducing or removing fluid

Methodology Applied

Scientific EffectPressure equilibrium: Pascal's Law

Implementation Method 2

featuring a filter to prevent vapor release and contamination

Methodology Applied

Scientific EffectVapor containment: Absorption (physical)

Data Source

PatentEP3552595A1Pressure-regulating VIAL adaptors

Publication Date: 2019.10.16 ICU MEDICAL INC

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Figure 2A

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.