Tamper-Evident Welded Closure for Drug Delivery Devices
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Solution Overview
Problem
Drug delivery devices are vulnerable to tampering and counterfeiting, as they can be disassembled and reassembled with different substances, posing risks to users, especially with high-value drugs like insulin.
Innovation Solution
A drug delivery device with a tamper-evident, permanent welded connection between the closure part and the housing, which can only be released by damaging one of the parts, making it difficult to reassemble without additional expensive processes, thus preventing unauthorized manipulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a pre-assembled drug delivery device is provided with conventional connections, then ease of manufacture is improved, but device security against tampering deteriorates
Solution Approach 1:
The connection element is extracted as a separate component that can be removed or destroyed to prevent tampering. The closure part is designed to be detachable under normal use but becomes permanently secured after the connection element is removed, creating a two-stage security system that balances ease of manufacture with anti-tampering reliability
Solution Approach 2:
The connection element is pre-installed in a removable state to facilitate assembly during manufacturing, but is designed to be permanently removed or destroyed before the device reaches the user. This preliminary action of removing the connection element creates irreversible evidence of proper assembly and prevents later tampering
2Reliability
If a permanent welded connection is used between closure part and housing, then device security against tampering is improved, but device complexity increases
Solution Approach 1:
The connection element is designed as a simple, inexpensive, single-use component that is removed or destroyed during the activation process. This disposable element provides the necessary security function without requiring complex permanent welding mechanisms, thereby maintaining device simplicity while achieving high security
Solution Approach 2:
The connection element serves as an intermediary component between the closure part and housing that facilitates assembly during manufacturing but is subsequently removed to create a permanent bond. This mediator approach allows the device to achieve welded-level security without actually implementing complex welding processes
3Ease of operation
If the closure part is easily detachable from the housing, then ease of operation is improved, but vulnerability to unauthorized manipulation increases
Solution Approach 1:
The connection state of the closure part dynamically changes during device activation. Initially, the closure part is easily detachable via the connection element to allow proper assembly and activation. After the connection element is removed, the closure part becomes permanently secured, creating a dynamic security system that adapts from easy operation to tamper-proof state
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 solution significantly reduces the likelihood of device tampering and counterfeiting, as any attempt to disassemble the device results in visible damage, deterring further manipulation and ensuring the integrity of the contained drug.
Implementation Method 1
a welded connection between a closure part (200) and a housing (100)
Data Source
AI summary
A drug delivery device is proposed which comprises: a housing defining an interior; a reservoir which is adapted to contain a drug or contains a drug, the reservoir being retained in the interior; and a closure part which is secured relative to the housing and has to be disconnected from the housing to get access to the reservoir within the interior, wherein the closure part is secured relative to the housing by a connection, wherein the connection comprises a welded connection, and wherein the welded connection is formed between two join partners, i.e. a first join partner and a second join partner. Further, a method for manufacturing a drug delivery device is disclosed as is a use associated with drug delivery devices.