Manual Infusion Pump Guidance via Pharmacokinetic Feedback
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Solution Overview
Problem
Current manual and automated drug infusion systems face challenges in accurately maintaining drug concentrations and infusion rates, leading to potential errors and the need for frequent regulatory approvals, which increases costs and delays the adoption of updated pharmacokinetic and pharmacodynamic models.
Innovation Solution
A user-guidance device that measures pump volume displacement parameters and calculates infusion rates based on pharmacokinetic and pharmacodynamic models, providing real-time feedback to clinicians to adjust infusion rates and maintain target drug concentrations, while being adaptable to existing manual infusion pumps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If target-controlled infusion devices are used to automatically control infusion rates, then infusion accuracy and safety are improved, but device complexity and regulatory compliance requirements increase
Solution Approach 1:
The system measures actual infusion rate and compares it with the target infusion rate calculated from pharmacokinetic models, providing feedback to adjust the infusion pump settings and maintain accurate drug delivery
Solution Approach 2:
A computer system acts as an intermediary between the pharmacokinetic models and the infusion pump, calculating target rates and monitoring actual delivery, thereby simplifying the overall system architecture while maintaining accuracy
2Reliability
If stringent regulatory compliance protocols are followed for autonomous infusion devices, then safety and efficacy are improved, but development time and costs increase
Solution Approach 1:
The system implements partial automation where the clinician sets target concentrations and the system handles rate calculations and monitoring, requiring less regulatory oversight than fully autonomous devices while still improving safety
Solution Approach 2:
The system automatically calculates infusion rates based on pharmacokinetic models and monitors actual delivery, reducing the need for continuous regulatory intervention and allowing faster updates when new models become available
3Ease of operation
If manual infusion control is used with clinician judgment, then ease of operation is improved, but infusion precision and consistency deteriorate
Solution Approach 1:
The system provides real-time feedback to the clinician by displaying target versus actual infusion rates, enabling informed manual adjustments while maintaining precision through continuous monitoring and calculation support
Data Source
AI summary
The invention provides a user-guidance device for informing a required change to a pump volume displacement parameter of a manual drug infusion pump assembly, for use with manually-controlled infusion of a drug into a patient. The user-guidance device comprises a measurement component arranged to measure the pump volume displacement parameter. The device further comprises a computing device arranged to calculate a measured rate of infusion of the drug based on the measured pump volume displacement parameter; and to calculate with reference to said measured rate of infusion and to at least one model selected from the group consisting of pharmacokinetic and pharmacodynamic models, a model-simulated drug concentration in the patient. The computing device may be arranged to derive user-guidance information based on the model-simulated drug concentration. The invention also provides a drug infusion system which includes the disclosed user-guidance device in combination with a manual drug infusion pump assembly.