Expandable Bag Vial Adaptor for Pressure Regulation

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Solution Overview

Problem

Existing systems for extracting medicinal fluids from vials face challenges such as pressure differential issues, contamination risks from ambient air, and complications in accurately removing and reinserting fluids due to the use of imperfect filters and complex, bulky devices.

Innovation Solution

A vial adaptor system that includes a piercing member and a bag within the adaptor, which expands or contracts to regulate pressure within the vial, allowing for the removal and reinsertion of fluids without significant pressure changes, and uses a substantially impervious bag to prevent contamination from ambient air.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If traditional filtering systems are used to prevent contamination, then contamination risk is reduced, but device complexity increases and filtration efficiency remains imperfect

Engineering Contradiction:
Improvecontamination riskVSAvoiddevice complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent removes the filtering component entirely from the system, extracting only the essential function of contamination prevention through the use of a sealed bag that physically isolates the medicinal fluid from ambient air, thereby simplifying the device while maintaining protection

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The sealed bag acts as an intermediary barrier between the medicinal fluid and ambient air, providing contamination protection without requiring complex filtering mechanisms. The bag mediates the interaction by creating a physical separation that prevents direct contact between potentially harmful air and the fluid

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stress or pressure

If pressure equalization holes are created in the vial, then pressure differential issues are resolved, but contamination risks increase from ambient air

Engineering Contradiction:
Improvepressure differentialVSAvoidcontamination risk
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The expandable bag serves as a mediator that allows pressure equalization without creating direct openings to ambient air. As the bag expands or contracts, it accommodates pressure changes internally while the sealed structure prevents external contamination

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system changes the physical state of the bag from collapsed to expanded as fluid is removed, allowing the bag volume to dynamically adjust and equalize pressure without requiring fixed pressure equalization holes that would compromise sterility

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If filters are used to manage pressure and prevent contamination, then some protection is provided, but fluid removal accuracy decreases due to filter imperfections

Engineering Contradiction:
Improvecontamination protectionVSAvoidfluid removal accuracy
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The patent extracts the filtering function from the pressure management system, eliminating the compromise between filtration and accuracy. Pressure management is achieved independently through bag expansion/contraction, while the sealed bag maintains contamination protection, allowing precise fluid measurement without filter interference

Inventive Principle:
Principle #2Taking out (Extraction)

4Stress or pressure

If complex pressure regulation devices are used, then pressure differential issues are resolved, but device simplicity and ease of operation are reduced

Engineering Contradiction:
Improvepressure regulationVSAvoidease of operation
Core Design Contradiction:
Stress or pressureVSEase of operation

Solution Approach 1:

The bag automatically regulates pressure through its own expansion and contraction as fluid is removed from the vial. The system is self-regulating without requiring external pressure management devices, making the operation simple and intuitive while effectively managing pressure differentials

Inventive Principle:
Principle #25Self-service

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 system effectively manages pressure differentials, reduces contamination risks, and facilitates accurate and safe removal and reinsertion of medicinal fluids, improving the efficiency and safety of medical procedures.

Implementation Method 1

the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial

Methodology Applied
Scientific EffectPressure regulation through expansion:

Implementation Method 2

the bag contracts within the vial... as the liquid is removed from the vial via the adaptor

Methodology Applied
Scientific EffectPressure regulation through contraction:

Data Source

PatentEP2010124B1Vial adaptors and vials for regulating pressure.
Publication Date: 2016.04.06 ICU MEDICAL INC
  • EP2010124B1 patent drawingFigure 1
  • EP2010124B1 patent drawingFigure 2
  • EP2010124B1 patent drawingFigure 3

AI summary

In certain embodiments, a vial adaptor for removing liquid contents from a vial includes a piercing member and a bag. The bag can be contained within the piercing member such that the bag is introduced to the vial when the vial adaptor is coupled with the vial. In some embodiments, the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial. In other embodiments, a vial includes a bag for regulating pressure within the vial as liquid is removed therefrom. In some embodiments, a vial adaptor is coupled with the vial in order to remove the liquid. In some embodiments, as the liquid is removed from the vial via the adaptor, the bag expands within the vial, and in other embodiments, the bag contracts within the vial.