Serially Connected Drug Module Sequence Verification Using Activation Codes
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Solution Overview
Problem
Combinatorial drug delivery devices with serially-connected drug modules lack a mechanism to ensure the correct configuration and sequence of drug modules, posing a risk of medication errors due to the absence of tray-based safety checks.
Innovation Solution
A system using machine-readable codes on drug modules, application software on a user's mobile device to generate an activation code based on the sequence of these codes, and a control unit on the drug delivery device to verify the accuracy of the module configuration by comparing the activation code with an authentication code, enabling the flow of liquid drugs only when a match is confirmed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If serially-connected drug modules are used to simplify the device structure and reduce components, then device complexity is reduced and supply chain efficiency is improved, but the ability to provide mechanical safety checks for correct module configuration is lost
Solution Approach 1:
The patent replaces the mechanical tray-based safety check system with an electronic verification system. Machine-readable codes are placed on each drug module, and a control unit with a processor reads and verifies these codes to ensure correct module configuration and sequence, thereby maintaining reliability without the mechanical tray structure.
Solution Approach 2:
The patent introduces machine-readable codes as an intermediary element between the drug modules and the verification system. These codes serve as a mediator that carries configuration information, allowing the control unit to verify module correctness without direct mechanical interaction or tray-based constraints.
2Reliability
If machine-readable code verification is implemented to ensure correct module configuration, then medication error prevention is improved, but device complexity and operational steps increase
Solution Approach 1:
The drug modules themselves carry the verification information through machine-readable codes attached to or integrated with the modules. The system verifies configuration by reading these self-contained codes on the modules, eliminating the need for external verification devices or complex manual checking procedures.
3Manufacturing precision
If machine-readable codes and verification software are added to verify module sequence, then configuration accuracy is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The patent uses machine-readable codes (such as barcodes or QR codes) that can be applied to disposable drug modules through simple labeling processes. These codes are inexpensive to produce and apply, enabling verification capability without significantly increasing manufacturing complexity or cost for single-use modules.
Data Source
AI summary
In one aspect, a system is provided of verifying the accuracy of a plurality of serially-connected drug modules of a combinatorial drug delivery device, each of the drug modules including a drug reservoir, the system including: a machine-readable code located on each of the drug modules; application software configured to generate an activation code based on the machine-readable codes and the sequence of the machine-readable codes; a flow controller on the drug delivery device which is selectively actuatable to a use state to permit flow of drug from the drug delivery device; and, a control unit on the drug delivery device having a computing processing unit configured to compare the activation code with an authentication code, and, wherein, if the authentication code matches the activation code, the computing processing unit causes actuation of the flow controller to permit flow of the drug from the drug delivery device.