Tamper-Evident Drug Reservoir Coding
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Solution Overview
Problem
Existing drug delivery devices lack mechanisms to prevent the incorrect use of cartridges, posing risks for patients, especially those with limited dexterity or color vision, and do not securely dedicate cartridges to specific medicaments, leading to potential misuse and counterfeiting.
Innovation Solution
A drug reservoir with a tamper-evident tear-away feature that covers coding elements, ensuring compatibility with authorized drug delivery devices and preventing unauthorized use, featuring materials like foil, vinyl, or acetate, and potentially colored or three-dimensional coding for secure identification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a removable feature is added to cover coding elements on the cartridge, then tamper-evidence and device compatibility are improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The cartridge assembly is divided into separate functional components: the cartridge body containing the medicament, the coding elements for device recognition, and the removable feature (foil, vinyl, or acetate material) that covers the coding elements. This segmentation allows each component to perform its specific function independently while maintaining overall system reliability.
Solution Approach 2:
The removable feature is pre-applied to the cartridge during manufacturing to cover the coding elements before the cartridge is used. This preliminary action ensures that the coding elements are protected and the cartridge appears authentic from the outset, preventing unauthorized use before the cartridge is properly inserted into the authorized device.
2Ease of operation
If color coding is used to help users identify the correct cartridge, then ease of operation is improved, but usability for color-blind or visually impaired patients deteriorates
Solution Approach 1:
In addition to color coding, the system incorporates asymmetric physical features such as raised tactile markings, varying shapes of coding elements, or non-uniform patterns on the removable feature. These asymmetric features provide multiple sensory cues that are not dependent on color perception, allowing color-blind or visually impaired patients to correctly identify and handle the appropriate cartridge.
Solution Approach 2:
The identification system transitions from relying solely on the two-dimensional color attribute to incorporating three-dimensional tactile features and spatial arrangements. The coding elements may include raised surfaces, different geometries, or specific positional arrangements that can be detected through touch or spatial orientation, adding another dimension to the identification process.
3Ease of manufacture
If standard-sized cartridges are used to comply with manufacturing standards, then ease of manufacture is improved, but the risk of cross-use with incorrect devices increases
Solution Approach 1:
While maintaining standard cartridge dimensions for ease of manufacture, the system incorporates localized unique identifiers and coding elements at specific positions on the cartridge. These local features, such as specific patterns, shapes, or arrangements of coding elements covered by the removable feature, provide device-specific recognition without requiring changes to the overall cartridge size or manufacturing processes.
Solution Approach 2:
The removable feature (foil, vinyl, or acetate material) acts as an intermediary layer between the standard-sized cartridge and the device's recognition system. This intermediary contains or covers the coding elements that provide unique identification, allowing standard cartridges to be differentiated through the information encoded in the removable feature rather than through physical dimensions.
Data Source
Figure 1A~1B
Figure 2~3
Figure 4A~4D
AI summary
A drug reservoir (200) comprises: a housing (204) having a proximal end and a distal end (202), wherein the housing (204) is configured to hold a medicament; a removable feature disposed on at least one of the proximal end and the distal end (202), wherein the removable feature covers at least in part one of the proximal end and the distal end (202).