Elastomeric Adaptor for Aseptic Vial Access

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Solution Overview

Problem

Multidose vaccine vials face challenges in maintaining sterility during multiple needle piercings, especially in non-aseptic conditions, leading to potential contamination and wastage of vaccines due to the need for successive piercings through a septum that is difficult to keep sterile.

Innovation Solution

An adaptor with a pierceable elastomeric piece that secures onto the vial septum, allowing multiple aseptic needle piercings by first cleaning the needle with the elastomeric piece before it enters the septum, and self-resealing to prevent contamination, using materials like silicone rubber with antiseptic agents to enhance sterility and prevent bacterial growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the septum is pierced multiple times for multidose administration, then the productivity and efficiency of vaccine distribution is improved, but the risk of contamination and loss of sterility increases

Engineering Contradiction:

Improvemultiple needle piercingsVSAvoidsterility maintenance

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The elastomeric piece acts as an intermediary component between the needle and the septum. It provides a controlled interface that allows repeated needle penetrations while maintaining the sterility of the vaccine container. The elastomeric material creates a seal around the needle, preventing ambient contamination from entering the vial during multiple access operations.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The elastomeric piece is a flexible membrane that can be repeatedly penetrated by needles while maintaining its sealing function. Its elastic properties allow it to deform around the needle during insertion and removal, then return to its original state to maintain the seal, enabling multiple access operations without compromising sterility.

Inventive Principle:

Principle #30Flexible shells and thin films

2Ease of operation

If the septum is exposed to ambient air during handling, then the ease of operation is improved, but the contamination risk from ambient air increases

Engineering Contradiction:

Improvehandling in ambient conditionsVSAvoidambient air contamination

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The elastomeric piece serves as a protective intermediary that shields the septum from direct exposure to ambient air during handling and needle insertion operations. It creates a barrier interface that allows operational access while preventing harmful environmental factors from contaminating the vaccine container.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The elastomeric piece creates a protected, effectively inert environment around the needle-septum interface. By sealing around the needle, it excludes ambient air and creates a controlled zone that prevents contamination during the piercing and withdrawal operations, allowing handling in non-sterile ambient conditions.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

3Reliability

If antiseptic agents are incorporated into the elastomeric piece, then the reliability of sterility is improved, but the complexity of manufacturing increases

Engineering Contradiction:

Improvesterility preventionVSAvoidmaterial composition

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The elastomeric piece is manufactured as a composite material combining base elastomeric polymer with incorporated antiseptic agents. This integration of multiple functional properties (elasticity, sealability, and antimicrobial activity) into a single composite component enhances sterility prevention while maintaining manufacturing feasibility through established composite material processing techniques.

Inventive Principle:

Principle #40Composite materials

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

Ensures aseptic conditions for multiple needle insertions into multidose vials, reducing vaccine wastage by maintaining sterility and preventing contamination, even in non-ideal storage and handling conditions.

Implementation Method 1

introducing the needle into the medical container implies that the needle pierces and traverses the elastomeric piece of the adaptor in the first place. During this step, the needle mechanically rubs against the material forming the elastomeric piece and it is naturally cleaned, as the potential bacteria are wiped from the needle

Methodology Applied

Scientific EffectFriction: Friction

Implementation Method 2

The elastomeric piece is self-resealing and it automatically seals the hole produced by the piercing of the needle, automatically and rapidly, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece

Methodology Applied

Scientific EffectElastic recovery: Elastic Recovery

Data Source

PatentUS10751252B2Adaptor for coupling with a medical container

Publication Date: 2020.08.25 BECTON DICKINSON HLDG

AI summary

An adaptor for coupling with a vial having a collar closed by a septum, the septum having an outer surface directed towards the outside of the vial, the adaptor comprising: a gripping member for securing the adaptor to the vial, the gripping member being capable of being laterally mounted on the collar of the vial and a pierceable elastomeric piece having at least a part intended to be in contact with the outer surface of the septum when the adaptor is secured on the vial. Also, an assembly including such an adaptor and a vial.