Needle Cover Segmentation for Closure Integrity and Removal Force
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Solution Overview
Problem
Current needle covers for medical injection devices face challenges in maintaining container closure integrity, preventing unintentional dislodgement, and requiring excessive force for removal, while also lacking features for tracking and ensuring the integrity of the pharmaceutical composition and tamper evidence.
Innovation Solution
A needle cover design featuring an inner shield with elastomeric properties and an outer shield with hooks, which reduces radial compression and includes a tamper evidence ring with RFID technology for tracking and ensuring the needle cover's integrity, allowing for easier removal and providing tamper evidence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radial compression of the inner needle shield on the tip is increased to ensure full closure integrity, then container closure integrity is improved, but the force needed to remove the needle cover increases
Solution Approach 1:
The needle cover is divided into two separate shields: an inner needle shield made of elastomeric material that provides sealing through axial compression, and an outer needle shield made of rigid material that provides structural support and prevents dislodgement. This segmentation allows each component to be optimized independently, resolving the contradiction between closure integrity and removal force.
Solution Approach 2:
Different materials and compression characteristics are applied to different parts of the needle cover system. The inner shield uses elastomeric material with specific durometer ranges (40-80 Shore A) to provide compliant sealing, while the outer shield uses rigid material for structural integrity. This local differentiation of material properties allows the system to achieve both strong closure and controlled removal.
2Stability of the object's composition
If the rigid outer needle shield is used to increase radial compression below the tip to avoid unintentional dislodgement, then stability is improved, but the force needed to remove the needle cover increases
Solution Approach 1:
The outer needle shield is designed as a separate component that can be optimized for stability without compromising removal. It provides rigid structural support and can include engagement features like flanges or ridges that prevent accidental dislodgement while still allowing intentional removal when needed.
Solution Approach 2:
The design allows adjustment of material properties (durometer of elastomeric material, thickness of rigid material) and geometric parameters (length of engagement, compression force distribution) to balance stability against intentional removal capability.
3Reliability
If the inner needle shield creates strong interference force with the tip to ensure full closure, then container closure integrity is improved, but ease of operation for removal deteriorates
Solution Approach 1:
By separating the sealing function (inner shield) from the structural function (outer shield), the design allows the inner shield to create strong interference fit for sealing while the outer shield provides the interface for removal. The outer shield can be designed with removal aids such as flanges, ridges, or engagement features that facilitate easy grasping and removal.
Solution Approach 2:
The outer needle shield acts as an intermediary between the user and the inner needle shield. It provides a convenient interface for grasping and removal while allowing the inner shield to maintain strong engagement with the tip for sealing purposes.
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 design enhances container closure integrity, reduces the force needed for removal, enables tracking and tamper evidence, and ensures the medical injection device contains the correct pharmaceutical composition, preventing unauthorized use.
Implementation Method 1
a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device and creates an axial compression on the distal end of the tip of the medical injection device
Implementation Method 2
The radial compression on the tip of the medical injection device is increased below the tip of the medical injection device using the rigid outer needle shield
Data Source
AI summary
A needle cover for protecting a needle mounted on a tip of a medical injection device, in which the tip extends from a distal end of the medical injection device, may include an inner shield extending along a longitudinal axis, and an outer shield surrounding at least partially the inner shield, and operatively connected to said inner shield, in which, when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device.