Insulin Pump Dosing Adjustment After Cannula Change

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Solution Overview

Problem

Current automated insulin delivery systems face challenges in adjusting insulin dosing protocols when switching between extended-wear in-dwelling catheters, leading to potential over-delivery of insulin at new insertion sites, which can cause hypoglycemic excursions.

Innovation Solution

A method and system that modify the dosing protocol based on a cannula change indicator, utilizing neural network calculations and historical error data to adjust insulin delivery, including lowering initial insulin doses and dynamically changing glucose thresholds, to prevent over-delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the dosing algorithm delivers the higher amount of insulin that was delivered just prior to removal of the first catheter, then the algorithm compensates for decreased insulin sensitivity at extended-wear sites, but the new site receives too much insulin causing hypoglycemic excursion

Engineering Contradiction:
Improveinsulin delivery accuracyVSAvoidhypoglycemic excursion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary action by detecting the cannula change indicator and proactively lowering the initial insulin dose before the hypoglycemic excursion can occur. The dosing protocol is modified in advance to account for the new insertion site's higher insulin sensitivity, preventing the harmful effect before it manifests.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system uses feedback by monitoring the cannula change indicator (such as pump rewind, reservoir change, or user input) and automatically adjusting the dosing protocol based on historical error data and neural network calculations. This closed-loop feedback mechanism ensures the dosing algorithm adapts to the new insertion site conditions.

Inventive Principle:
Principle #23Feedback

2Duration of action of stationary object

If extended-wear in-dwelling catheters are used for greater than 3 days, then the infusion set provides sustained insulin delivery, but insulin sensitivity at the insertion site decreases requiring higher insulin amounts

Engineering Contradiction:
Improvecatheter wear timeVSAvoidinsulin sensitivity
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The system applies dynamics by making the dosing protocol adaptive and dynamic rather than static. The algorithm continuously monitors insulin sensitivity changes over time and automatically adjusts the insulin delivery rate to compensate for the decreasing sensitivity at extended-wear sites, maintaining reliable glucose control throughout the catheter's wear duration.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes parameters by dynamically modifying dosing protocol parameters (insulin sensitivity factor, basal rate, bolus calculations) based on the catheter wear time and observed glucose responses. This allows the system to adapt to the changing physiological conditions at the insertion site over extended periods.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the dosing protocol is modified using neural network calculations and historical error data, then the initial insulin dose is lowered to prevent over-delivery, but the system complexity increases

Engineering Contradiction:
Improveinsulin delivery safetyVSAvoiddosing protocol modification system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system applies self-service by automatically modifying the dosing protocol using built-in neural network calculations and historical error data without requiring external intervention. The system serves itself by detecting cannula changes and autonomously adjusting dosing parameters, reducing the need for manual programming or complex external control systems.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS20230241314A1Event-driven compensated insulin delivery over time
Publication Date: 2023.08.03 TANDEM DIABETES CARE INC
  • US20230241314A1 patent drawing
  • US20230241314A1 patent drawing
  • US20230241314A1 patent drawing

AI summary

Embodiments of systems and methods for delivering a medicament using a pump are provided. The methods comprise inserting a first cannula into subcutaneous tissue. Medicament is delivered from a medicament pump through the first cannula according to a dosing protocol. The first cannula can removed after a period of time and a second cannula can be inserted. The method comprises modifying the dosing protocol based upon a cannula change indicator, the modifying comprising performing neural network calculations utilizing previously calculated error data, resulting in a modified dosing protocol. Medicament is delivered from the medicament pump through the second cannula according to the modified dosing protocol.