Auto-Injector Cap and Safety Shield for Misuse Prevention
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Solution Overview
Problem
Existing automatic drug delivery devices face issues such as complex assembly and manufacturing, potential misuse, non-intuitive activation mechanisms, inadequate protection of safety shields, and insufficient feedback to users, along with challenges in handling prefilled syringe assemblies and removable caps.
Innovation Solution
The device incorporates a flexible gripping element for easy assembly and handling of the needle shield, provides visual and tactile feedback, and includes a safety shield mechanism with a biasing force to prevent accidental activation, while ensuring sterility and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a safety shield with flexible arms blocking mechanism is used, then the needle tip is protected in safety position, but the safety shield becomes complicated in geometry and manufacturing
Solution Approach 1:
The blocking mechanism is extracted from the safety shield and implemented as a separate needle shielding member. This member can be independently actuated to block the needle tip without requiring the safety shield itself to contain complex blocking arms, thereby simplifying the safety shield's geometry and manufacturing while maintaining reliable needle protection.
Solution Approach 2:
The safety system is segmented into distinct functional components: the safety shield for covering the needle, and a separate needle shielding member for blocking the needle tip. This segmentation allows each component to be simpler in design while collectively providing robust needle protection.
2Reliability
If rotational activation mechanism is used, then the automatic drug delivery device can be activated, but the rotational movements are not intuitive which makes the use uncomfortable for users
Solution Approach 1:
Instead of requiring rotational movement to activate the device, the invention uses a push-button mechanism where axial pressing motion triggers activation. This inverts the activation paradigm from rotational to linear, making it more intuitive and easier to operate while maintaining reliable activation functionality.
3Ease of operation
If button triggering mechanism is used, then the injection process can be initiated, but the device has potential of misuse as the triggering mechanism can be activated although not placed correctly on injection site
Solution Approach 1:
The push-button mechanism is designed with preliminary anti-action features where the button cannot be pressed unless the device is correctly positioned on the injection site. The mechanical structure prevents premature activation by requiring proper alignment and contact forces, thereby eliminating misuse potential while maintaining ease of injection initiation.
4Reliability
If multiple components interact during relative movements for actuation, then the injection process can be triggered, but the manufacturing and assembly become complicated
Solution Approach 1:
Multiple actuation components are merged into an integrated actuation assembly where the push-button, safety shield, and needle shielding member are coupled in a unified mechanical structure. This merging reduces the number of separate parts requiring assembly while maintaining the reliable multi-stage triggering sequence for injection.
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 enhances assembly efficiency, reduces the risk of misuse, provides intuitive operation, and ensures secure handling and effective feedback, thereby improving user experience and device safety.
Implementation Method 1
a biasing element arranged within the longitudinal housing and acting on the safety shield in order to bias the safety shield into the first position
Implementation Method 2
The removable cap includes a flexible gripping element for engaging the needle shield on its outer circumferential surface
Data Source
AI summary
The invention relates to an automatic drug delivery device (10), in particular automatic drug delivery device, for dispensing a fluid product, in particular a fluid medicament, including: a longitudinal housing (104) extending along a longitudinal axis and having a proximal end close to the dispensing site, a distal end opposite to the proximal end and a hollow interior; a removable cap (50) mountable to the proximal end of the housing (104); a syringe assembly (200) arranged a mounting position inside the housing (104) and having a hollow syringe body (204) and an injection needle (206) coupled to the hollow syringe body (204) including the fluid product; a drive mechanism (300) which can be triggered by a trigger element in order to initiate the dispensing of the fluid product; wherein the loaded drive mechanism is operatively coupled with a safety shield (102) movable within the longitudinal housing (104), wherein the safety shield (102) is biased into a proximal position in which it protrudes out of the proximal end of the longitudinal housing (104) in order to cover a needle tip (348) of the injection needle (206), and wherein the safety shield (104) is movable into a distal position in which the injection needle (206) is exposed for injection; wherein the syringe assembly is provided with a needle shield fixed to a proximal end of the hollow syringe body and covering the needle together with its sharpened needle tip; wherein the removable cap includes a flexible gripping element for engaging the needle shield on its outer circumferential surface such that removal of the removable cap results in removal of the needle shield, the flexible gripping element having a greater diameter than a proximal end of the safety shield.