Aseptic Dose Counting Device for Medical Vials

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Solution Overview

Problem

Vaccines are often wasted due to contamination and improper handling, especially in remote areas where maintaining sterile conditions is challenging, and there is a need for a device that allows aseptic multiple piercings of multidose vial septums while accurately counting doses.

Innovation Solution

A dose counting device that secures to a medical container with a gripping member, featuring a pierceable elastomeric piece and an incrementing system, ensuring aseptic conditions by automatically rotating a counting ring to track the number of doses withdrawn, even with accidental or incomplete manipulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If multidose vials are used to reduce packaging waste and improve supply chain efficiency, then the number of containers needed is reduced and storage efficiency is improved, but the risk of contamination increases with repeated piercings of the septum

Engineering Contradiction:

Improvesupply chain efficiencyVSAvoidsterility maintenance

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent introduces a dose counting device as an intermediary component that couples between the injection device and the multidose vial. This device includes a pierceable elastomeric piece that acts as a mediator: the needle pierces through the elastomeric piece to access the vial contents, while the elastomeric piece maintains the sterile barrier. This allows multiple dose withdrawals while preserving septum sterility, as the elastomeric piece can be pierced repeatedly without compromising the underlying septum integrity.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If the septum is pierced multiple times to withdraw doses, then more patients can be vaccinated from a single vial, but the sterility of the septum is compromised with each piercing

Engineering Contradiction:

Improvenumber of doses withdrawnVSAvoidcontamination risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The dose counting device is pre-assembled with the pierceable elastomeric piece in place before use. This preliminary preparation ensures that the elastomeric piece is already positioned to protect the septum, so that when multiple piercings are needed, the pre-established barrier is repeatedly penetrated without exposing the septum to contamination. The counting ring is also pre-configured to track doses from the start.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The elastomeric piece serves as a reusable intermediary that absorbs the mechanical stress of repeated needle piercings. Instead of the needle directly piercing the septum multiple times, it first penetrates the elastomeric piece, which then seals around the needle. This mediator approach allows unlimited piercings while the septum remains protected behind the elastomeric barrier.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Loss of information

If a dose counting device is added to track doses withdrawn, then accurate inventory management is achieved, but the device complexity increases

Engineering Contradiction:

Improvedose tracking accuracyVSAvoiddevice structure

Core Design Contradiction:

Loss of informationVSDevice complexity

Solution Approach 1:

The patent replaces complex electronic counting systems with a simple mechanical incrementing system. The counting ring with numbered positions and an incrementing mechanism that advances one position per dose withdrawal provides accurate tracking through pure mechanical means. This substitution eliminates the need for batteries, circuits, or digital displays, reducing device complexity while maintaining reliable dose counting functionality.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Ease of operation

If the cover is made movable to allow access to the opening, then aseptic access is enabled, but the risk of accidental contamination increases

Engineering Contradiction:

Improveaccess to openingVSAvoidcontamination risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The cover is designed as a dynamic component that can rotate between a closed position (protecting the opening and elastomeric piece) and an open position (allowing needle access). This dynamic design enables controlled access: the cover remains closed during storage and transport to prevent contamination, and is opened only momentarily during dose withdrawal. The elastomeric piece provides continuous protection even when the cover is open, as it seals around the needle during piercing.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS9713574B2Dose counting device for coupling with a medical container

Publication Date: 2017.07.25 BECTON DICKINSON FRANCE SAS

AI summary

The present invention relates to a dose counting device (10) for coupling with a medical container filled with a number N of doses of a product to be withdrawn therefrom, said medical container being provided with an opening for access to said product, the dose counting device comprising: —a gripping member (20) for securing the dose counting device to the medical container, said gripping member including a hole (44) intended to face said opening when said dose counting device is coupled to said medical container, —a counting ring (30) rotatably mounted with respect to said gripping member, said counting ring being provided with information data corresponding to the N doses, a cover (50) movable with respect to said opening between a closed position, in which said cover prevents access to said opening and to said product, and an open position, in which it does not prevent access to said opening and product.