Medicinal Vial Stopper Dual-Bore Design for Residual Medicament Reduction

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Solution Overview

Problem

Conventional medicinal vial stoppers leave residual amounts of medicament in the vial due to the 'ride-up' and diameter of the closed end of the headspace, leading to inefficiencies in drug withdrawal, especially concerning the increasing cost of medications.

Innovation Solution

A vial stopper design featuring a first bore with a constant diameter and a second bore with a greater diameter, where the centrally-located piercable portion of the stopper flange is resiliently deformable upon piercing, forming a fluid impenetrable seal and allowing complete withdrawal of the medicament through a vent, reducing residual amounts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of substance

If a conventional stopper design with a closed end headspace is used, then the stopper can be easily manufactured and inserted, but residual medicament remains in the vial after withdrawal

Engineering Contradiction:
Improveresidual medicamentVSAvoidstopper structure
Core Design Contradiction:
Loss of substanceVSDevice complexity

Solution Approach 1:

The stopper plug is divided into multiple functional zones: a first bore with constant diameter for initial withdrawal, and a second bore with greater diameter for complete evacuation. This segmentation allows different withdrawal stages to occur through different bore configurations, minimizing residual medicament while maintaining manufacturing feasibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-bore cylindrical headspace to a multi-bore configuration with varying diameters. By introducing dimensional variation in the bore structure (from constant diameter to expanded diameter), the system enables complete medicament withdrawal while managing the complexity through systematic design.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If the stopper flange is made rigid for structural stability, then the stopper maintains its shape during insertion, but it cannot form a tight seal with the spike

Engineering Contradiction:
Improveseal formationVSAvoidstopper flange rigidity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The stopper flange transitions from a static rigid structure to a dynamic resilient structure that deforms upon spike insertion. This dynamic behavior allows the flange to conform to the spike surface, forming a fluid-impenetrable seal while maintaining overall structural integrity through elastic recovery.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stopper flange material properties are changed to exhibit resilience and deformability. By adjusting the material parameters (elasticity, hardness), the flange can dynamically adapt its shape during sealing while maintaining sufficient structural strength for insertion and operation.

Inventive Principle:
Principle #35Parameter changes

3Loss of substance

If a single large bore is used for complete medicament withdrawal, then all medicament can be removed, but the stopper structure becomes complex and difficult to manufacture

Engineering Contradiction:
Improveresidual medicamentVSAvoidstopper fabrication
Core Design Contradiction:
Loss of substanceVSEase of manufacture

Solution Approach 1:

Instead of creating one complex large bore, the invention segments the withdrawal path into two simpler bores: a first bore for initial withdrawal and a second bore for complete evacuation. This segmentation simplifies manufacturing while achieving the goal of minimal residual medicament through systematic hole formation.

Inventive Principle:
Principle #1Segmentation

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 new stopper design minimizes residual medicament in the vial, ensuring nearly complete withdrawal by forming a tight seal with the spike, thereby reducing waste and optimizing drug usage.

Implementation Method 1

the centrally-located piercable portion of the stopper flange is resiliently deformable and upon being pierced by the spike tightly conforms to the radially outwardly facing sidewall of the shaft

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3274265B1Medicinal vial stopper
Publication Date: 2023.09.27 WEST PHARMACEUTICAL SERVICES INC
  • EP3274265B1 patent drawingFigure 1
  • EP3274265B1 patent drawingFigure 2
  • EP3274265B1 patent drawingFigure 3

AI summary

A medicinal vial stopper has a stopper plug extending from a stopper flange. The stopper plug is insertable with a compression fit in the neck of the vial. A first bore within the stopper plug has a radially inwardly facing first-bore surface having a constant first-bore diameter the entire first-bore length and a first-bore first end closed by a centrally-located piercable portion of the stopper flange. A second bore within the stopper plug has a radially inwardly facing second-bore surface having a constant second-bore diameter the entire second-bore length. The second-bore diameter is greater than the first-bore diameter. The second-bore first end is in fluid communication with the first-bore second end. The centrally-located piercable portion of the stopper flange is resiliently deformable and upon being pierced by a spike tightly conforms to the radially outwardly facing sidewall of the shaft; thereby forming a fluid impenetrable seal.