Ambulatory Pump Distress Notifications

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Solution Overview

Problem

Current glucose control systems for managing blood glucose levels in subjects, particularly those using ambulatory medicament pumps, face challenges in efficiently delivering and controlling multiple glucose control agents, such as insulin and glucagon, with limited user interface safety features to prevent inadvertent therapy changes.

Innovation Solution

The implementation of a blood glucose control system that includes a controller generating dose control signals for multiple glucose control agents, integrated with an ambulatory medicament pump, featuring a user interface that requires specific interactions and safety protocols to modify therapy settings, and includes remote monitoring and alert systems to manage glucose levels effectively.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple glucose control agents are delivered through an ambulatory medicament pump, then glucose control effectiveness is improved, but device complexity increases

Engineering Contradiction:
Improveglucose control effectivenessVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The pump system is divided into separate delivery channels, each dedicated to a specific glucose control agent (insulin, glucagon, etc.). This segmentation allows multiple agents to be delivered independently through the same pump device while maintaining clear control over each agent's delivery parameters and reducing cross-contamination risks.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The ambulatory medicament pump is designed with multi-functional capability to deliver various types of glucose control agents through a unified platform. The pump can switch between different medicament types and delivery modes, providing universal glucose control functionality without requiring separate devices for each agent.

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

2Reliability

If user interface safety features are added to prevent inadvertent therapy changes, then patient safety is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvepatient safetyVSAvoidease of operation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system requires preliminary confirmation actions before implementing therapy changes. Users must explicitly confirm dosage adjustments or therapy modifications through additional input steps, ensuring that inadvertent changes are prevented while still allowing intentional changes to be made. This preliminary confirmation step acts as a safety checkpoint without completely blocking legitimate therapy adjustments.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20230337949A1Ambulatory medicament pump with distress notifications
Publication Date: 2023.10.26 BETA BIONICS INC
  • US20230337949A1 patent drawing
  • US20230337949A1 patent drawing
  • US20230337949A1 patent drawing

AI summary

A glucose level control system may be configured to determine that certain status information fails to satisfy at least one of a plurality of safety thresholds. The system may receive status information, which may include device information pertaining to a condition of the ambulatory medicament device and/or subject information pertaining to a condition of a subject. The system can determine that the status information fails to satisfy the safety threshold(s). In response to determining that the status information fails to satisfy the at least one of a plurality of safety thresholds, the system can automatically execute a distress action. Example safety thresholds include a glucose level of a subject being less than a minimum threshold, a glucose level of a subject being greater than a maximum threshold, a movement of the subject being less than a minimum movement threshold for a threshold amount of time, and/or other safety thresholds.