Automated Injection Device for Lyophilized Medicament Reconstitution

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Solution Overview

Problem

Conventional pen-style injectors require manual activation for reconstituting lyophilized medicaments, which can be difficult to perform at a controlled rate, leading to incomplete reconstitution and potential inefficacy of the medicament.

Innovation Solution

An automated injection device with a cartridge having separate chambers for a lyophilized and liquid substance, a plunger, and a biasing member that automatically mixes the substances upon activation, ensuring consistent and complete reconstitution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If manual activation is used for reconstitution, then the device structure is simple, but the reconstitution rate cannot be controlled consistently and may be too fast causing foam

Engineering Contradiction:
Improveautomated reconstitutionVSAvoiddevice structure
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The device uses a spring-loaded plunger that automatically pushes the liquid substance into the lyophilized substance chamber when the seal is broken, eliminating the need for manual activation and providing self-service reconstitution

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The liquid substance is pre-loaded into a separate chamber with a plunger ready to dispense, and the lyophilized substance is pre-placed in the main chamber, allowing immediate controlled reconstitution upon activation without manual preparation

Inventive Principle:
Principle #10Preliminary action

2Reliability

If manual reconstitution is performed, then the device is easier to manufacture, but incomplete reconstitution may occur reducing medicament efficacy

Engineering Contradiction:
Improvecomplete reconstitutionVSAvoiddevice manufacturing
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The device incorporates a visual indicator that changes state when reconstitution is complete, providing feedback to the user and ensuring reliable completion of the reconstitution process before injection

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The liquid substance and plunger are extracted into a separate pre-filled chamber, allowing the reconstitution process to be isolated and controlled independently from the injection mechanism, ensuring complete mixing

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If manual rotation or axial movement is used for reconstitution, then the device structure is simpler, but ergonomic concerns arise and the procedure is difficult for some individuals

Engineering Contradiction:
Improvereconstitution operationVSAvoidmechanism structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The spring-loaded plunger automatically performs the reconstitution action when activated by breaking the seal, eliminating the need for users to perform difficult manual rotations or axial movements

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Instead of requiring the user to manually move components to achieve reconstitution, the device is designed so that breaking the seal triggers the automatic reverse action of the plunger pushing the liquid forward

Inventive Principle:
Principle #13The other way round (Inversion)

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 device ensures consistent and complete reconstitution of medicaments, reducing ergonomic concerns and the risk of incomplete reconstitution, thereby improving the efficacy of the administered dosage.

Implementation Method 1

a biasing member, a sleeve, biased by the biasing member and communicating the bias to the plunger

Methodology Applied
Scientific EffectElastic potential energy: Elasticity

Data Source

PatentEP2709695B1Injection device with automated substance combining feature
Publication Date: 2019.11.20 BECTON DICKINSON & CO
  • EP2709695B1 patent drawingFigure 1
  • EP2709695B1 patent drawingFigure 2
  • EP2709695B1 patent drawingFigure 3

AI summary

An injection device for automatically combining two substances, including a body and a cartridge displaceably disposed within the body having a first chamber for containing a first substance, a second chamber for containing a second substance, a first stopper displaceably disposed within the cartridge separating the first and second chambers, a second stopper displaceably disposed within the cartridge defining an end of the second chamber. The device also includes a needle hub displaceably disposed within the body having threads thereon for connecting a pen needle to the injection device. The device additionally includes a plunger displaceably disposed within the body, a biasing member, a sleeve, biased by the biasing member and communicating the bias to the plunger, and an activation button radially displaceable with respect to the body to selectively release the sleeve to drive the plunger and automatically mix the first and second substances.