Dose Setting Mechanism Asymmetric Cartridge Authentication
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Solution Overview
Problem
Existing drug delivery devices lack mechanisms to prevent the incorrect use of medicament cartridges, posing risks for patients, especially those with limited dexterity or color vision impairments, and do not securely authenticate cartridges, leading to potential misuse or counterfeiting.
Innovation Solution
A dose setting mechanism with a dispensing lock feature that only allows correct cartridges to dispense medication, utilizing coding features on both the cartridge and the device to ensure compatibility and prevent unauthorized use, and incorporating design elements like split rings and angled surfaces to secure the correct cartridge assembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard sized cartridges are used to comply with manufacturing standards, then manufacturing ease and compatibility are improved, but the risk of incorrect medicament use increases
Solution Approach 1:
The patent introduces asymmetric coding features (protrusions and recesses) on cartridges that do not conform to standard symmetric designs. These asymmetric features must match corresponding features on the dose setting mechanism, ensuring that only correctly coded cartridges can be loaded and dispensed. This resolves the contradiction by maintaining standard cartridge sizes for manufacturing ease while adding asymmetric authentication features that prevent incorrect medicament use.
Solution Approach 2:
The coding features are pre-configured on cartridges during manufacturing before use. The asymmetric protrusions and recesses are built into the cartridge structure in advance, allowing the dose setting mechanism to authenticate the cartridge before dispensing occurs. This preliminary authentication prevents incorrect medicament administration while maintaining standard cartridge dimensions.
2Ease of operation
If color coding schemes are used to assist users in selecting cartridges, then ease of identification is improved, but usability for color blind or elderly patients deteriorates
Solution Approach 1:
The patent replaces the optical/color-based identification system with a mechanical authentication system. Instead of relying on color codes that are invisible to color-blind or visually impaired users, the invention uses tactile mechanical features (asymmetric protrusions and recesses) that can be detected through touch and physical engagement. This mechanical system ensures reliable identification and prevention of incorrect cartridge use regardless of the user's visual capabilities.
3Device complexity
If no authentication mechanism is provided, then device complexity is reduced, but the risk of unauthorized use and counterfeiting increases
Solution Approach 1:
The patent implements asymmetric coding features consisting of specific patterns of protrusions and recesses on the cartridge that must match corresponding features on the dose setting mechanism. This asymmetric mechanical authentication ensures that only authorized, correctly coded cartridges can be loaded and dispensed, preventing unauthorized use and counterfeiting while adding only minimal structural complexity to the cartridge design.
4Reliability
If a dispensing lock feature is added to prevent incorrect dispensing, then medication safety is improved, but device complexity increases
Solution Approach 1:
The patent merges the authentication and dispensing control functions into a single integrated mechanism. The asymmetric coding features serve dual purposes: they authenticate the cartridge identity and simultaneously control the dispensing lock. When the coding features match, the mechanism automatically enables dispensing; when they don't match, dispensing is prevented. This integration achieves high safety without proportionally increasing device complexity.
Data Source
Figure 1A~1B
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AI summary
A dose setting mechanism (202) that prevents dispensing of a drug when an incorrect cartridge assembly (204) is attached to the dose setting mechanism (202). Dispense of a drug may be allowed by preventing rotation of a spindle nut (208) of a drug delivery device (200), and dispense of a drug may be prevented by not preventing rotation of the spindle nut (208). Preventing dispense of a drug may be accomplished by preventing rotation of the spindle (206) when an incorrect cartridge assembly (204) is inserted. Preventing dispense of a drug may be accomplished by preventing the spindle (206) from applying an axial force on the cartridge when an incorrect cartridge assembly (204) is inserted.