Medicament Delivery Safety Arrangement with Blocking Element
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Solution Overview
Problem
Existing medicament delivery devices face issues with container breakage during injection procedures, leading to hazardous ejection of broken pieces and potential needle exposure, and previous safety arrangements complicate needle shield removal and manufacturing.
Innovation Solution
A safety arrangement with a blocking element and initiating structure that repositions to prevent container pieces from exiting during breakage, ensuring safety without interfering with needle integrity or complicating the device's design, featuring a container holder and shell configuration with a blocking element that moves with the container holder to obstruct broken parts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid needle shield with diameter equal to or larger than the container barrel is used, then the needle shield provides adequate protection and enables easier handling, but the container holder structure becomes more complex and manufacturing difficulty increases
Solution Approach 1:
The container holder is divided into a proximal portion and a distal portion, with the blocking feature located in the proximal portion. This segmentation allows the holder to accommodate both the needle shield and the blocking mechanism without increasing overall complexity, as each section has a dedicated function.
Solution Approach 2:
The blocking feature is integrated within the proximal portion of the container holder, nesting the safety mechanism inside the existing holder structure. This allows the blocking function to be added without requiring separate external components, thereby avoiding increased device complexity.
2Ease of manufacture
If the container holder structure is simplified for easier manufacture, then manufacturing complexity is reduced, but the ability to prevent ejection of broken container pieces is compromised
Solution Approach 1:
The container holder is segmented into functional zones: the proximal portion contains the blocking feature to prevent ejection, while the distal portion maintains simple container engagement. This segmentation allows the safety function to be integrated without complicating the overall manufacturing process.
Solution Approach 2:
The blocking feature is localized to the proximal portion of the container holder, where it is most needed for safety. The rest of the holder structure remains simple and easy to manufacture. This local addition of complexity only where necessary maintains ease of manufacture while ensuring safety.
3Reliability
If the blocking element is positioned to effectively prevent container ejection, then safety against breakage is improved, but contact with the needle shield increases potentially compromising needle integrity
Solution Approach 1:
The blocking feature is localized to the proximal portion of the container holder, positioned to interact only with the container body. This localized positioning ensures effective prevention of container ejection while maintaining sufficient distance from the needle shield to avoid contact and potential needle damage.
Solution Approach 2:
The proximal portion of the container holder acts as an intermediary between the blocking feature and the container, allowing the blocking mechanism to prevent ejection without direct interaction with the needle shield. This intermediary structure isolates the blocking function from the needle protection zone.
4Reliability
If additional safety features are added to prevent container breakage ejection, then safety is improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The blocking feature is merged with the proximal portion of the container holder, combining the safety function with the existing holder structure. This integration adds the safety feature without requiring separate components or mechanisms, thereby avoiding increased overall device complexity.
Solution Approach 2:
The blocking feature is nested within the proximal portion of the container holder, incorporating the safety mechanism inside the existing structure. This nesting approach allows the safety function to be added without increasing the number of external components or overall device complexity.
Data Source
AI summary
A safety arrangement for being used in a medicament delivery device, comprising a container holder with a body section and a flange seat and a shell. The container holder is arranged to receive a container with a longitudinal body at one end passing over into a distal flange and at an opposite end passing over into a proximal orifice via a shoulder, such that the distal flanges of the container contacts the flange seat of the container holder. Moreover, the container holder is arranged in the shell such that the container holder is movable in a proximal direction in relation to the shell. A blocking element is arranged between the shell and the container holder. A blocking initiating structure is arranged to reposition the blocking element when the container holder is moved in the proximal direction in relation to the shell from a first position to a second position.