Infusion Pump Control Unit with Dynamic Glucose Thresholds

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Solution Overview

Problem

Current Low Glucose Suspend (LGS) systems for diabetes management are limited by static glucose thresholds, leading to false alarms and inadequate hypoglycemia handling, particularly at night or during activities that require different glucose levels, and they are not cost-effective or technically complex.

Innovation Solution

A control unit for insulin pumps that continuously evaluates glucose levels and generates adaptive control signals to temporarily suspend or reduce insulin infusion based on real-time glucose data and sensor inputs, allowing for dynamic hypoglycemia intervention without requiring static threshold settings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If static glucose thresholds are used in LGS systems, then the system is simple and cost-effective, but false alarms increase and hypoglycemia handling becomes inadequate

Engineering Contradiction:
Improvehypoglycemia detection accuracyVSAvoidcontrol system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements dynamic glucose thresholds that automatically adjust based on time of day, physical activity level, and glucose trend. During nighttime sleep, thresholds are raised to prevent false alarms, while during daytime activities, thresholds adapt to activity intensity. This dynamic adjustment resolves the contradiction by maintaining high detection accuracy without requiring complex closed-loop control systems.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the threshold parameter dynamically based on multiple inputs including time of day, detected physical activity, and glucose trend direction. By modifying the threshold parameter adaptively rather than using a fixed value, the system achieves reliable hypoglycemia detection across varying conditions while keeping the overall system architecture simple and cost-effective.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If closed-loop systems are implemented, then hypoglycemia management improves, but cost and technical complexity increase significantly

Engineering Contradiction:
Improvehypoglycemia prevention capabilityVSAvoidsystem architecture complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the control function by separating glucose monitoring from insulin dosing control. Instead of implementing a full closed-loop system that automatically adjusts insulin delivery, the system segments the approach by providing intelligent alerts and recommendations to the user, who then makes the dosing decision. This segmentation achieves improved hypoglycemia management while avoiding the complexity and cost of automated insulin delivery hardware and control algorithms.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system introduces an intermediary layer between glucose monitoring and insulin dosing - an intelligent alert system that processes glucose data, evaluates hypoglycemia risk based on multiple parameters, and provides recommended actions to the user. This intermediary approach achieves reliable hypoglycemia prevention without requiring the complex automated control mechanisms of closed-loop systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If static shutoff thresholds are used, then the system operates simply, but nocturnal hypoglycemia awareness is insufficient and false alarms occur

Engineering Contradiction:
Improvesystem operation simplicityVSAvoidnocturnal hypoglycemia detection
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements time-dependent threshold adjustment where the glucose threshold automatically increases during nighttime hours when the user is sleeping. This dynamic time-based adjustment maintains simple operation - the user does not need to manually change settings - while significantly improving nocturnal hypoglycemia detection reliability by raising the threshold to account for reduced awareness during sleep.

Inventive Principle:
Principle #15Dynamics

4Reliability

If continuous glucose monitoring with adaptive thresholds is implemented, then false alarms are reduced, but system complexity increases

Engineering Contradiction:
Improvealarm accuracyVSAvoidcontrol algorithm complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system changes the threshold parameter based on multiple inputs including time of day, physical activity level, and glucose trend direction. By implementing parameter changes rather than complex control algorithms, the system achieves high alarm accuracy while maintaining relatively simple system architecture that does not require full closed-loop control.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2862586B1Control unit for infusion pump units, including a controlled intervention unit
Publication Date: 2021.09.01 ROCHE DIABETES CARE GMBH
  • EP2862586B1 patent drawingFigure 1~2b
  • EP2862586B1 patent drawingFigure 3~4
  • EP2862586B1 patent drawingFigure 5

AI summary

The present disclosure is directed towards a control unit (12) for an electronically controlled pump unit (11), the control unit (12) being designed to control the pump unit (11) to infuse insulin into a diabetic's body in a substantially continuous way according to a preset infusion schedule as a function of time. The control unit (12) includes an intervention unit (124), the intervention unit (124) being designed to continuously evaluate a blood-glucose indicative input for detecting an actual or expected hypoglycaemia and to execute, in response to an actual or expected hypoglycaemia, a temporary hypoglycaemia intervention, the hypoglycaemia intervention including, for an intervention time interval, overriding the preset infusion schedule by temporarily suspending insulin infusion or temporarily reducing insulin infusion below the preset infusion schedule. The intervention unit (124) is designed to adopt its way of operation with respect to executing the hypoglycaemia intervention in accordance with a control signal the control signal being separate from the blood-glucose indicative input. The control unit is designed to automatically generate the control signal as a function of time and/or based on sensor input.