Closed-Loop Insulin Delivery Control for Manual Dosing Errors

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Solution Overview

Problem

Current insulin pump systems require manual input for insulin delivery rates, which can be inaccurate due to various factors such as incorrect blood glucose readings, carbohydrate counting, and unpredictable bodily responses, posing risks of hypoglycemia and long-term complications in diabetes management.

Innovation Solution

A closed-loop system incorporating a medical fluid pump, continuous analyte monitors, and a controller that adjusts insulin delivery based on real-time data from sensors, including glucose levels, accelerometers, and other health indicators to maintain optimal blood glucose levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual input is used for insulin delivery rates, then the system is simple to operate, but the accuracy of insulin delivery is poor

Engineering Contradiction:
Improveinsulin delivery accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system implements a closed-loop feedback mechanism where continuous analyte monitors (glucose sensors) provide real-time data to the controller, which automatically adjusts insulin delivery rates. This feedback loop eliminates manual input errors and maintains accurate glucose control without requiring patient calculations or manual rate adjustments.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The insulin pump system performs self-adjustment of delivery rates based on sensor data from continuous analyte monitors. The controller automatically processes glucose level information and modulates insulin flow without user intervention, enabling the system to self-regulate and maintain optimal glucose levels autonomously.

Inventive Principle:
Principle #25Self-service

2Reliability

If manual calculation of insulin rates is used, then the device is easy to use, but the reliability of diabetes management is poor

Engineering Contradiction:
Improvediabetes management reliabilityVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The closed-loop system continuously monitors analyte levels and automatically adjusts insulin delivery, eliminating the need for manual calculations. This feedback-driven approach significantly improves reliability by removing human error factors such as incorrect carbohydrate counting or miscalculation of insulin requirements, while the automated nature handles complexity internally.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system replaces manual mechanical operations (patient manually calculating and setting insulin rates) with automated electronic control. The controller processes sensor data and automatically modulates the pump mechanism, substituting human manual operations with an automated electronic control system that enhances reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If automated closed-loop control is implemented, then insulin delivery accuracy is improved, but the device complexity increases

Engineering Contradiction:
Improveinsulin delivery precisionVSAvoidcontrol system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The controller serves multiple functions: it processes data from continuous analyte monitors, calculates appropriate insulin delivery rates, controls the pump mechanism, and monitors system status. By consolidating these diverse functions into a single multi-functional controller, the system achieves high precision while managing complexity through functional integration rather than separate components.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system merges the analyte monitoring function, control processing, and insulin delivery control into an integrated closed-loop system. The continuous analyte monitor, controller, and pump are combined and communicate seamlessly, reducing the need for separate manual operations and improving precision through coordinated automated control.

Inventive Principle:
Principle #5Merging (Combining)

4Productivity

If real-time sensor data is used for control, then the effectiveness of insulin delivery is improved, but the amount of information processing increases

Engineering Contradiction:
Improveinsulin delivery effectivenessVSAvoidinformation processing load
Core Design Contradiction:
ProductivityVSLoss of information

Solution Approach 1:

The continuous analyte monitor provides uninterrupted real-time glucose level data to the controller, enabling continuous adjustment of insulin delivery. This continuous information flow and continuous control action maximize delivery effectiveness by responding immediately to glucose level changes without interruption or delay.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system uses real-time feedback from continuous analyte monitors to dynamically adjust insulin delivery rates. The controller processes sensor data continuously and modifies pump operation in real-time based on glucose levels, creating a responsive closed-loop control that enhances effectiveness while managing information processing through automated algorithms.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3881874A1Systems and methods for fluid delivery
Publication Date: 2021.09.22 DEKA PRODUCTS LP
  • EP3881874A1 patent drawingFigure 1
  • EP3881874A1 patent drawingFigure 2
  • EP3881874A1 patent drawingFigure 3

AI summary

A system for at least partial closed-loop control of a medical condition is disclosed. The system includes at least one medical fluid pump. The medical fluid pump included a sensor for determining the volume of fluid pumped by the pump. Also at least one continuous analyte monitor, and a controller. The Controller is in communication with the medical fluid pump and the at least one continuous analyte monitor. The controller includes a processor. The processor includes instructions for delivery of medical fluid based at least on data received from the at least one continuous analyte monitor.