Elastic Needle Shield Remover for CCI-Safe Syringe Assembly
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Solution Overview
Problem
Existing needle shield removers for medicament delivery devices apply axial forces during assembly, which can compromise the container closure integrity (CCI) of prefilled syringes, posing a risk of contamination.
Innovation Solution
A one-part needle shield remover with an elastic sleeve that applies radial forces during assembly, ensuring CCI by using a cap with a bore and an elastic sleeve that expands radially to securely hold the needle shield without metal inserts, facilitated by multi-component injection molding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a needle shield remover with metal insert and barbed hooks is used, then the needle shield can be securely anchored to the cap, but axial forces are applied to the needle shield during assembly which compromises container closure integrity
Solution Approach 1:
The patent changes the force application parameter from axial to radial direction. The elastic sleeve applies radial forces to the needle shield during assembly, which is perpendicular to the traditional axial force direction. This parameter change allows secure anchoring while preserving container closure integrity, as radial forces do not compromise the syringe seal.
Solution Approach 2:
The patent employs an elastic sleeve made of flexible material that can deform radially to engage the needle shield. This flexible component allows the needle shield to be anchored securely through radial expansion and contraction, eliminating the need for rigid metal inserts that apply harmful axial forces.
2Ease of manufacture
If a needle shield remover with rigid structure is used, then assembly is simple, but axial forces affect CCI and contamination risk increases
Solution Approach 1:
The patent changes the force vector from axial to radial direction. By using an elastic sleeve that expands radially to engage the needle shield, the design eliminates axial force application that would compromise CCI. The radial expansion mechanism is simple to manufacture through elastic material deformation, achieving both ease of manufacture and contamination prevention.
3Productivity
If traditional needle shield removers are used, then needle shield removal is achieved, but manufacturing speed is limited due to complex assembly processes
Solution Approach 1:
The patent merges the anchoring and removal functions into a single integrated elastic sleeve component. The elastic sleeve simultaneously provides radial engagement for anchoring and elastic deformation for removal, eliminating the need for separate metal inserts and barbed hooks. This merging simplifies the assembly process and enables high-speed manufacturing.
Solution Approach 2:
The patent changes the mechanical interaction from rigid axial engagement to flexible radial deformation. The elastic sleeve can be quickly expanded and contracted radially to engage and release the needle shield, a process that is both simple and fast. This parameter change reduces assembly complexity and increases manufacturing speed significantly.
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
Maintains CCI integrity while easily removing the needle shield, allowing for high-speed manufacturing and reducing the risk of contamination, with materials meeting biocompatibility standards.
Implementation Method 1
an elastic sleeve positioned within the bore and the elastic sleeve includes a holding section for receiving and/or holding the needle shield
Data Source
AI summary
A needle shield remover for a medicament delivery device comprising a needle shield includes a cap with a side wall providing a bore, the proximal section of the side wall is configured for attachment to the medicament delivery device. An elastic sleeve positioned in the bore includes a holding section for holding the needle shield. The needle shield remover includes a distal end wall connecting the elastic sleeve to the cap. A passage is provided in the distal end wall connecting the inner space of the elastic sleeve to the exterior, the passage being configured for receiving an expansion tool for expanding the elastic sleeve to fit around the needle shield.