Insulin Pump Disconnection Bolus for Glycemic Control

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Solution Overview

Problem

Diabetes patients face challenges in safely disconnecting insulin infusion systems, leading to interruptions in basal insulin delivery, which can result in glycemic control issues and potentially life-threatening ketoacidosis due to existing technologies' inability to manage disconnections effectively.

Innovation Solution

A disconnectable insulin delivery system that uses a glucose measurement device to determine the amount of insulin for dispensing based on current glucose levels and contemplated disconnection time, allowing for controlled disconnection and reconnection with features like disconnection and reconnection boluses to maintain blood glucose within target ranges.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the insulin infusion system is disconnected to allow patient mobility or device maintenance, then ease of operation is improved, but glycemic control reliability deteriorates due to interruptions in basal insulin delivery

Engineering Contradiction:

Improvepatient mobility and device maintenanceVSAvoidglycemic control

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system calculates and delivers a disconnection bolus dose of insulin before the pump is disconnected, ensuring that insulin coverage is maintained during the disconnection period. This preliminary action prevents glycemic control deterioration while allowing the pump to be safely disconnected for mobility or maintenance purposes.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The controller acts as an intermediary between the disconnection event and glycemic control maintenance. It automatically calculates the appropriate disconnection bolus dose based on current glucose levels, insulin sensitivity, and disconnection duration, then delivers this dose to bridge the gap in basal insulin delivery during pump disconnection.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the pump is disconnected for prolonged periods, then ease of operation is improved, but harmful effects increase due to potential ketoacidosis

Engineering Contradiction:

Improvedisconnection flexibilityVSAvoidketoacidosis risk

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

Before allowing pump disconnection, the system preemptively delivers a disconnection bolus dose calculated to maintain glycemic control throughout the disconnection period. This preliminary insulin delivery prevents the development of ketoacidosis by ensuring adequate insulin coverage even when basal delivery is interrupted.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The disconnection bolus dose acts as a cushion against potential hyperglycemia and ketoacidosis during the disconnection period. By delivering this additional insulin dose beforehand, the system creates a safety buffer that protects against harmful metabolic effects even if the disconnection lasts longer than expected.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If continuous basal insulin delivery is maintained without disconnection, then glycemic control is improved, but loss of time increases due to limited patient mobility and convenience

Engineering Contradiction:

Improveglycemic controlVSAvoidpatient mobility restriction

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system enables patients to disconnect the pump by delivering a disconnection bolus dose in advance, which maintains glycemic control during the disconnection period. This allows patients to gain mobility freedom without compromising glycemic reliability, effectively eliminating the trade-off between continuous delivery and patient convenience.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If a disconnection bolus dose is delivered to maintain glycemic control during disconnection, then glycemic control is improved, but device complexity increases due to additional control logic and calculations

Engineering Contradiction:

Improveglycemic control during disconnectionVSAvoidcontrol system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The controller automatically performs all necessary calculations and delivers the disconnection bolus dose without requiring complex user input or manual intervention. The system self-determines the appropriate dose based on stored patient parameters (insulin sensitivity, carbohydrate ratios) and current glucose measurements, simplifying the user interface while maintaining sophisticated control logic.

Inventive Principle:

Principle #25Self-service

Data Source

PatentEP2180909B1Systems and methods for glycemic control during pump disconnection

Publication Date: 2016.09.21 ROCHE DIABETES CARE GMBH

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AI summary

Techniques and devices are described for allowing a diabetes patient to safely disconnect an insulin infusion system device for a time period. In one aspect, the techniques and devices can be implemented by receiving a maximum blood glucose amount, a minimum blood glucose amount, and a contemplated disconnection time; receiving a current blood glucose amount of the user; determining an expected increase in blood glucose of the user based on the contemplated disconnection time, an insulin sensitivity of the user and a contemplated basal insulin dose; validating the contemplated disconnection time based on at least one of the expected increase in blood glucose, the maximum blood glucose amount, and the minimum blood glucose amount; and, administering a therapeutic action to the user based on the validation of the contemplated disconnection time.