Infusion Pump Closed-Loop Mode Bolus Interruption

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Solution Overview

Problem

Current insulin infusion pump systems lack the ability to seamlessly integrate user-initiated bolus dosages with closed-loop delivery modes, potentially leading to overdoses or underdoses due to the lack of real-time adjustment for previously dispensed insulin and user input, and do not provide adequate safety features to prevent insulin stacking.

Innovation Solution

A portable insulin infusion pump system that allows temporary interruption of closed-loop delivery mode for user-prompted bolus dosages, calculates the dosage based on both user input and previously dispensed insulin, and includes safety features to prevent insulin stacking by calculating a stacking value and alerting the user if it exceeds a predetermined threshold.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If the closed-loop delivery mode is continuously operated without interruption, then the automation of insulin dispensation is maximized, but the flexibility for user-prompted bolus dosages is lost

Engineering Contradiction:
Improveautomation of insulin dispensationVSAvoidflexibility for user-prompted bolus dosages
Core Design Contradiction:
Extent of automationVSAdaptability or versatility

Solution Approach 1:

The system dynamically switches between closed-loop delivery mode and manual bolus dosage mode based on user input. When a user prompts for a bolus dosage, the system temporarily interrupts the automated closed-loop delivery and transitions to manual mode to administer the user-specific dosage. After bolus delivery, the system automatically returns to closed-loop mode. This dynamic switching enables both high automation during normal operation and user flexibility when needed.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If user-prompted bolus dosages are allowed to interrupt closed-loop delivery, then the adaptability for user-specific needs is improved, but the complexity of dosage calculation and control is increased

Engineering Contradiction:
Improveadaptability for user-specific needsVSAvoidcomplexity of dosage calculation and control
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system uses feedback from the glucose sensor to continuously monitor blood glucose levels and adjusts insulin dispensation accordingly in closed-loop mode. When a user prompts for a bolus dosage, the system incorporates feedback about the current glucose level, previously dispensed insulin amounts, and the requested bolus dosage into a comprehensive calculation. This feedback mechanism ensures that the system can handle user-specific needs while maintaining controlled and accurate dosage calculations through continuous monitoring and adjustment.

Inventive Principle:
Principle #23Feedback

3Device complexity

If the system calculates dosage based only on current blood glucose level, then the simplicity of control is maintained, but the precision of dosage accuracy is reduced due to lack of consideration for previously dispensed insulin

Engineering Contradiction:
Improvesimplicity of controlVSAvoidprecision of dosage accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The system performs preliminary calculations to determine the amount of insulin already dispensed during closed-loop delivery and estimates its remaining effectiveness before calculating the bolus dosage. By accounting for previously dispensed insulin and its duration of action, the system avoids redundant dosing and potential stacking errors. This preliminary action of assessing the current insulin state enables precise dosage accuracy while maintaining relatively simple control through automated calculations.

Inventive Principle:
Principle #10Preliminary action

4Reliability

If safety features for preventing insulin stacking are added, then the reliability of the system is improved, but the device complexity increases

Engineering Contradiction:
Improvereliability of the systemVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system continuously monitors and calculates the amount of insulin already dispensed during closed-loop delivery and estimates its remaining effectiveness. This feedback about the current insulin state is used to determine safe bolus dosage limits and prevent stacking errors. By incorporating this feedback mechanism, the system achieves high reliability through automated safety checks while managing device complexity through integrated control logic.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3288454B1Operating an infusion pump system
Publication Date: 2024.05.29 INSULET CORP
  • EP3288454B1 patent drawingFigure 1
  • EP3288454B1 patent drawingFigure 2
  • EP3288454B1 patent drawingFigure 3

AI summary

Some embodiments an infusion pump system can be configured to control dispensation of medicine according to a closed-loop delivery mode that is responsive to feedback information provided from a monitoring device, and the infusion pump system permits a user to interrupt the closed-loop delivery mode for purposes of dispensing a user-selected manual bolus dosage.