Medicament Delivery Device Segmented Drive for Safe Reconstitution

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Solution Overview

Problem

Existing medicament delivery devices often fail to ensure complete and uninterrupted mixing of medicament and diluent agents before delivery, risking accidental administration of unreconstituted medicament.

Innovation Solution

A medicament delivery device with a movable medicament delivery drive unit that separates from the actuation mechanism, ensuring complete mixing before allowing delivery, by transitioning from a first to a second position, thereby preventing accidental activation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the medicament delivery drive unit is integrated with the actuator, then the device structure is compact, but accidental delivery may occur before mixing is complete

Engineering Contradiction:
Improveprevention of accidental deliveryVSAvoidseparation of drive unit and actuator
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into separate functional modules: the medicament delivery drive unit is separated from the actuator. The drive unit includes a piston for mixing while the actuator is dedicated to delivery activation. This segmentation ensures that mixing completion must be detected before the actuator can engage the drive unit, preventing accidental delivery.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mixing action is performed as a preliminary step before delivery can be activated. The drive unit must complete the mixing cycle and be detected in its retracted position before the actuator can engage to perform delivery. This preliminary action sequence ensures mixing is complete before administration.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the actuator can engage the drive unit at any position, then delivery can be activated quickly, but unreconstituted medicament may be administered

Engineering Contradiction:
Improveensuring complete mixing before deliveryVSAvoidtime to activate delivery
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

A detection mechanism monitors the position of the medicament delivery drive unit and provides feedback control. The actuator is enabled to engage the drive unit only when the detection mechanism confirms the drive unit has reached its retracted position, indicating mixing completion. This feedback control ensures mixing is complete before delivery activation is permitted.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The engagement capability of the actuator is made dynamic rather than static. The actuator transitions from a disabled state to an enabled state based on the drive unit position. This dynamic control allows quick activation once mixing is complete while preventing premature activation during mixing.

Inventive Principle:
Principle #15Dynamics

3Ease of operation

If the drive unit remains in the first position, then the device is ready for immediate delivery, but mixing may be incomplete

Engineering Contradiction:
Improvereadiness for deliveryVSAvoidcompleteness of mixing
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A detection mechanism acts as an intermediary between the drive unit position and the actuator engagement. This intermediary verifies that the drive unit has reached the retracted position indicating mixing completion before allowing the actuator to engage. This intermediary ensures reliability while maintaining ease of operation through automatic verification.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2670458B1Medicament delivery device
Publication Date: 2019.05.29 SHL MEDICAL AG
  • EP2670458B1 patent drawingFigure 1
  • EP2670458B1 patent drawingFigure 2
  • EP2670458B1 patent drawingFigure 3

AI summary

A medicament delivery device for a reconstituted medicament, comprising a proximal housing part (12; 12''; 12'''), a distal housing part (10; 10''; 10'''), a medicament delivery drive unit and actuation means, wherein the medicament delivery drive unit is mounted in said distal housing part and wherein the actuation means further include an activation member (74; 101; 201) which is displaceable between an inactive position wherein the actuator is prevented from engaging the medicament delivery drive unit and an active position wherein the actuator is able to engage the medicament delivery drive, whereby the actuator is capable of interacting with said medicament delivery drive unit to perform a delivery of the reconstituted medicament only in the active position of the activation member and in the second position of the medicament delivery drive unit.