Pen Injection Drive Assembly Anti-Counterfeit Clutch Design
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Solution Overview
Problem
Pen-type injection devices for diabetes management often have design flaws that allow for improper use and inaccurate dosing, which can be fatal, and are vulnerable to counterfeiting due to accessible mechanisms that can be manipulated by users or counterfeiters.
Innovation Solution
A drive assembly for pen-type injection devices that integrates the clutch component with the number sleeve, eliminating the need for flexible assembly fingers and using detent pockets instead of cut-out holes to prevent disassembly and ensure secure dosing, thereby enhancing user safety and preventing counterfeiting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the clutch component is separate from the number sleeve with accessible flexible assembly fingers, then the device allows for easier assembly and disassembly, but this enables counterfeiting and improper manipulation by users
Solution Approach 1:
The clutch component is integrated with the number sleeve to form a single unified component. This merging eliminates the separate flexible assembly fingers that were accessible from the outside, thereby preventing counterfeiting and improper manipulation while maintaining manufacturing feasibility through integral construction
Solution Approach 2:
The flexible assembly fingers and cut-out holes are completely removed from the design. By extracting these vulnerable elements, the patent eliminates the security weakness that allowed counterfeiting, while the clutch and number sleeve functions are achieved through the integral structure without requiring separate flexible components
2Ease of manufacture
If cut-out holes are used in the number sleeve for assembly fingers, then the structure is simpler to manufacture, but this allows tool access for disassembly and counterfeiting
Solution Approach 1:
The cut-out holes are completely removed from the number sleeve structure. By extracting these openings, the patent eliminates the access points that allowed counterfeiters to insert tools and manipulate the internal mechanisms, while the integral clutch-component design achieves the necessary functionality without requiring such openings
3Device complexity
If the device uses a traditional clutch mechanism with flexible fingers, then the dose setting mechanism is simpler, but this allows accidental disassembly and improper use
Solution Approach 1:
The clutch mechanism is merged with the number sleeve to create an integral structure. This combination eliminates the separate flexible fingers that could accidentally disengage, thereby preventing accidental disassembly and ensuring dose accuracy while maintaining reasonable mechanical simplicity through the unified design
Data Source
AI summary
A drive assembly for a drug delivery device includes a housing; a number sleeve threadedly engaged with the housing; a dial link rotatably fixed with the number sleeve in a first axial arrangement relative to each other, the number sleeve being rotatable relative to the dial link in a second axial arrangement; a clutch component connected to an inner proximal section of the number sleeve through multiple flexible assembly fingers. The clutch component can engage the number sleeve with the dial link in the first axial arrangement and disengage the number sleeve from the dial link in the second axial arrangement. The drive assembly includes means for preventing an access to the flexible assembly fingers from the outer proximal section of the number sleeve and/or the flexible assembly fingers from flexing inwardly and disengaging from the connection with the inner proximal section.


