Infusion Pump Mode Transition Management

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Solution Overview

Problem

Infusion pump systems face challenges in seamlessly transitioning between operating modes, potentially compromising user safety and experience due to unsatisfied preconditions and disruptive alerts, while existing systems lack customizable control over physiological conditions.

Innovation Solution

The infusion device employs a management system with multiple control modules, a supervisory module, and a command multiplexer to manage transitions between operating modes based on operational and clinical information, ensuring compliance with regulatory requirements and user preferences by selecting the most suitable mode and transferring relevant operational data.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the infusion pump supports multiple different operating modes to provide greater control over the user's physiological condition, then the adaptability and control capability are improved, but the complexity of managing transitions between modes increases and may compromise user safety and experience

Engineering Contradiction:
Improvecontrol capabilityVSAvoidmode transition management
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

A supervisory module is introduced as an intermediary between the control modules and the user interface. This supervisory module manages mode transitions by evaluating preconditions, determining appropriate destination modes, and coordinating the switching process, thereby reducing the complexity burden on the overall system while maintaining multiple operating modes for enhanced adaptability

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If preconditions are enforced before entering a particular operating mode to ensure safety and regulatory compliance, then the reliability is improved, but the ease of operation deteriorates as users may be frustrated when their mode selection is denied

Engineering Contradiction:
Improvesafety complianceVSAvoiduser convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The supervisory module performs preliminary evaluation of preconditions before allowing mode transitions. By checking safety requirements and regulatory constraints in advance, the system can provide clear feedback to users about why a mode cannot be entered, allowing users to adjust their requests accordingly. This preliminary action maintains safety while improving user experience through transparent communication

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

When a user's mode selection is denied due to unsatisfied preconditions, the system provides feedback explaining the reason for denial. This feedback mechanism helps users understand the safety constraints and adjust their mode selection, thereby maintaining reliability while improving ease of operation through informed user decision-making

Inventive Principle:
Principle #23Feedback

3Extent of automation

If the system automatically determines the destination operating mode based on operational and clinical information to ensure safety, then the extent of automation is improved, but the device complexity increases due to the need for sophisticated mode management logic

Engineering Contradiction:
Improvemode selection automationVSAvoidcontrol system structure
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The control system is segmented into distinct functional components: control modules that implement specific operating modes, a supervisory module that manages transitions, and a command multiplexer that routes commands. This segmentation allows automation of mode selection while distributing complexity across modular components, making the system more manageable and maintainable

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3796330B1Methods for operating mode transitions and related infusion devices and systems
Publication Date: 2024.10.23 MEDTRONIC MINIMED INC
  • EP3796330B1 patent drawingFigure 1
  • EP3796330B1 patent drawingFigure 2
  • EP3796330B1 patent drawingFigure 3

AI summary

An infusion system and a method of operating an infusion device to deliver fluid to a user is provided. The system operates the infusion device to deliver the fluid in an automated manner in accordance with a first operating mode of a plurality of different operating modes, each operating mode of the plurality of different operating modes generating commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme associated therewith. It obtaines operational information pertaining to the operating of the infusion device in accordance with the first operating mode and clinical information pertaining to the user. It then determines a destination operating mode of the plurality of different operating modes based at least in part on the operational information and the clinical information, and then transitions operation of the infusion device from the first operating mode to the destination operating mode, wherein the destination operating mode is initialized using at least a portion of the operational information pertaining to the operating of the infusion device in accordance with the first operating mode, and operates the infusion device to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by the portion of the operational information pertaining to the first operating mode.