Drug Delivery Parameter Verification via Redundant Smartphone Calculations
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Solution Overview
Problem
The use of consumer electronic devices, such as smartphones, for programming medical devices like infusion pumps poses safety issues due to differences in safety and reliability profiles, as they lack redundancy methods like hardware duplication and diverse redundancy calculations, making it challenging to ensure accurate and safe drug delivery operations.
Innovation Solution
A method involving a remote control device that computes drug delivery instructions using basic mathematical operations and communicates them to a redundancy module for validation, preventing execution if instructions conflict, ensuring safe drug delivery operations by using wireless communication and a comparator module to verify matching instructions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If consumer electronic devices are used to program medical devices, then ease of operation and accessibility are improved, but safety and reliability deteriorate due to lack of redundancy mechanisms
Solution Approach 1:
The patent introduces a safety module as an intermediary component between the consumer electronic device and the medical device. This safety module acts as a mediator that receives commands from the consumer device, performs redundant safety-critical calculations independently, and validates the results before allowing execution. This resolves the contradiction by maintaining the ease of operation (consumer device can still program) while ensuring safety (through the intermediary safety module's verification).
Solution Approach 2:
The patent changes the operational parameters of the calculation process by implementing dual independent calculation channels within the safety module. One channel performs the primary calculation while the other performs redundant verification calculations. The parameters being verified include bolus amount, duration, and delivery timing. This parameter-level redundancy ensures reliability while allowing the consumer device interface to remain user-friendly.
2Reliability
If redundancy methods are implemented in consumer electronic devices, then safety and reliability are improved, but device complexity increases
Solution Approach 1:
The patent segments the system into distinct functional components: the consumer electronic device for user interaction, the communication interface for data transfer, and the safety module for verification. By segmenting the redundancy functionality into a dedicated safety module rather than embedding it throughout the entire consumer device, the complexity is isolated and managed in a specific subsystem while the overall consumer device remains simple and familiar.
Solution Approach 2:
The safety module serves as an intermediary that handles all complexity-related redundancy operations. Instead of modifying the consumer device's internal complexity, the safety module externalizes the redundant calculation logic, receiving simple commands from the consumer device and returning validation results. This keeps the consumer device architecture simple while achieving high reliability through the intermediary's sophisticated verification processes.
3Measurement precision
If redundant calculations are performed via two independent channels, then detection of erroneous operation is improved, but computational resources and processing time increase
Solution Approach 1:
The patent implements partial redundancy by focusing verification efforts on only the safety-critical parameters (bolus amount, duration, delivery timing) rather than redundantly calculating all possible parameters. The safety module performs selective redundant verification on these critical values, achieving high detection accuracy for erroneous operations while minimizing unnecessary computational resource consumption on non-critical parameters.
Solution Approach 2:
The patent optimizes the use of computational resources by changing how parameters are processed: instead of performing full redundant calculations for all device operations, the system identifies and prioritizes safety-critical parameters for redundant verification. This parameter-based prioritization allows the two independent calculation channels to focus their computational efforts where they provide the most value for error detection, reducing overall energy consumption while maintaining high detection accuracy.
Data Source
AI summary
The safety and reliability of drug delivery systems are improved by the use of smartphones for calculating safety critical delivery parameters. A drug delivery device is adapted to perform a drug delivery operation based on an unconfirmed drug delivery instructions determined by a processing unit of a control device by applying a basic mathematic operation to control device input data. The drug delivery device comprises a communication module to receive, from the control device, the basic mathematic operation and the control device input data, and a redundancy module to determine a redundant drug delivery instructions by applying the basic mathematic operation to the control device input data received from the control device. The drug delivery device is adapted to prevent execution of the drug delivery operation if the unconfirmed drug delivery instructions and the redundant drug delivery instructions are found, by a comparator module, to conflict.