Needle Shield Release Mechanism for Hub Integration
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Solution Overview
Problem
Existing needle-based medical devices lack a passive safety shield that can easily and passively activate and disconnect from a hub, such as a catheter introducer hub, and the existing shielding devices protrude into the hub, interfering with hemostatic valves and seals.
Innovation Solution
A needle device with a hub, a needle, and a moveable needle shield assembly that transitions from a non-shielding to a shielding position, featuring a latch and locking member to securely lock the shield in place, ensuring the needle is shielded before disconnection, allowing space for hemostatic devices within the hub.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle shield assembly is designed to passively activate and disconnect from a hub, then ease of operation is improved, but device complexity increases due to the latch and locking member mechanisms
Solution Approach 1:
The needle shield assembly is designed to automatically activate and disconnect through passive mechanical interaction with the hub. The latch and locking member mechanisms engage and disengage automatically based on the relative motion between the shield assembly and hub, eliminating the need for manual activation or complex control systems.
Solution Approach 2:
The locking member is positioned within the hub structure, and the latch engages with internal features of the hub. The nested configuration allows the shield assembly to integrate with the hub while maintaining a compact form factor and enabling automatic engagement/disengagement through simple relative motion.
2Ease of operation
If the needle shield assembly is designed to disconnect from the hub, then ease of operation is improved, but reliability decreases due to potential failure of the disconnection mechanism
Solution Approach 1:
The disconnection mechanism relies on passive mechanical interaction rather than active control. The latch and locking member automatically disengage when the needle shield assembly is withdrawn from the hub, reducing the number of moving parts and potential failure points while maintaining reliable disconnection.
Solution Approach 2:
The disconnection function is separated into distinct mechanical elements (latch and locking member) that operate independently. This segmentation allows each component to be optimized for its specific function and simplifies the overall disconnection mechanism, improving reliability through modular design.
3Adaptability or versatility
If the needle shield assembly is designed to allow space for hemostatic devices within the hub, then adaptability is improved, but device complexity increases due to spatial constraints
Solution Approach 1:
The locking member is positioned within the hub structure, nesting components within available space. This nested configuration allows the shield assembly to disconnect from the hub while maintaining sufficient internal volume for hemostatic valves and seals, achieving adaptability without excessive complexity.
Solution Approach 2:
The hub structure is designed with specific local features (luer connector, internal cavity) that accommodate both the locking mechanism and hemostatic devices. The latch engages with the luer thread in one location while the internal cavity provides space for hemostatic components in another, allowing multi-functionality through localized design features.
Data Source
AI summary
A needle-based medical device and method of manufacturing the same are disclosed. A needle device includes a hub having a longitudinal axis; a needle having a sharp distal tip; and a needle shield assembly associated with the needle and moveable from a non-shielding position to a shielding position. In the shielding position, the sharp distal tip is covered by at least part of the needle shield assembly. A latch is further provided for engaging with the hub when the needle shield assembly is in the non-shielding position; as well as a locking member operably connected to the needle shield assembly, and located at least partially within the hub when the needle shield assembly is in the non-shielding position. The latch and locking member lock the latch to the hub, such that when the needle shield assembly moves into the shielding position, the locking member moves generally proximally, unlocking the latch.