Heat Shrinkable Label for Disposable Injection Device Tamper Evidence

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Solution Overview

Problem

Disposable drug delivery devices lack mechanisms to prevent unintentional use of manipulated cartridges, which can lead to dose accuracy issues and health problems, and there is a need to detect any attempts to manipulate these devices.

Innovation Solution

A disposable injection device with a housing and cartridge holder formed as a unitary component, featuring a heat shrinkable label that covers the interface between the housing and cartridge holder, providing information and symbols about the medicament and serving as a tamper-evident mechanism to indicate if the device has been manipulated, while also enhancing the structural integrity of the device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a disposable injection device uses a simple cartridge holder design that allows easy cartridge replacement, then ease of operation is improved, but reliability deteriorates due to risk of unintentional cartridge replacement and dose accuracy issues

Engineering Contradiction:
Improveease of cartridge replacementVSAvoiddose accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The heat shrinkable label is applied to the cartridge holder before the cartridge is inserted, creating a tamper-evident seal in advance. This preliminary action ensures that any subsequent manipulation of the cartridge or cartridge holder will be evident through label damage, preventing unintentional replacement while maintaining reliable dose delivery

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a disposable injection device adds a heat shrinkable label and unitary housing structure, then reliability is improved by preventing manipulation, but device complexity increases

Engineering Contradiction:
Improveprotection against manipulationVSAvoidstructural complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The housing and cartridge holder are formed as a unitary component, merging two separate elements into one integrated structure. This consolidation simplifies the overall device architecture while the heat shrinkable label provides the necessary tamper-evident functionality without requiring additional mechanical locking mechanisms or complex assembly steps

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If the heat shrinkable label covers the interface between housing and cartridge holder, then reliability is improved by preventing detachment, but manufacturing precision requirements increase

Engineering Contradiction:
Improvestructural integrityVSAvoidlabel positioning accuracy
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The heat shrinkable label is applied specifically to the cartridge holder portion that interfaces with the housing, concentrating the tamper-evident functionality where it is most needed. The label's heat shrinkage process creates a form-fit attachment that adapts to the local geometry of the cartridge holder, reducing the need for high-precision positioning while maintaining reliable attachment and tamper evidence

Inventive Principle:
Principle #3Local quality

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 heat shrinkable label ensures that the cartridge holder remains inseparably locked to the housing, preventing unintentional cartridge replacement and providing a secure means to display information about the medicament, thus maintaining dose accuracy and indicating any attempts at manipulation.

Implementation Method 1

The label is heat shrunk onto the housing (2) and cartridge holder (3) such that it at least partially covers the housing (2) and the cartridge holder (3)

Methodology Applied
Scientific EffectHeat shrinkage: Thermal Contraction

Data Source

PatentEP3990064B1Injection device
Publication Date: 2024.10.09 SANOFI SA(FR)
  • EP3990064B1 patent drawingFigure 1~3

AI summary

The present invention refers to an injection device (1) comprising a housing (2) containing a dose setting mechanism, a cartridge holder (3) containing a cartridge with a medicament, and a heat shrinkable label (8) which comprises information (9) and/or symbols about the medicament. The injection device (1) is a disposable injection device (1) with the cartridge holder (3) inseparably locked to the housing (2). The heat shrinkable label (8) is heat shrunk on the housing (2) and the cartridge holder (3) such that it at least partially covers the housing (2) and the cartridge holder (3).