Insulin Pump Bolus Segmentation for Hypoglycemia Prevention

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Solution Overview

Problem

Current insulin pump therapies deliver insulin boluses rapidly, leading to excessive glucose metabolism and potentially dangerous drops in blood glucose, especially with the use of ultra-rapid acting insulins and complementary therapies like pramlintide.

Innovation Solution

The insulin pump system modifies the delivery of insulin boluses to accommodate more rapidly acting insulins and complementary drug therapies, using metrics such as bolus extension and shape to match the post-prandial rise in blood glucose, and incorporates a controller to manage the delivery based on the administration of pramlintide or similar agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If insulin bolus is delivered rapidly as in traditional insulin pump therapy, then the insulin acts quickly to metabolize glucose, but this causes excessive glucose metabolism and dangerous drops in blood glucose levels

Engineering Contradiction:
Improveinsulin delivery speedVSAvoidhypoglycemic events
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent segments the insulin bolus delivery into multiple smaller deliveries over time. Instead of delivering the entire bolus at once, the system divides it into an initial portion delivered immediately and subsequent portions delivered at predetermined intervals, preventing excessive glucose metabolism and hypoglycemic events while maintaining effective blood glucose control

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements dynamic insulin delivery protocols that adjust the timing and amount of insulin based on real-time blood glucose monitoring. The system dynamically modifies delivery parameters including bolus extension, wave-shaped delivery patterns, and adaptive intervals between deliveries to match the body's actual glucose metabolism needs, preventing both hyper- and hypoglycemia

Inventive Principle:
Principle #15Dynamics

2Speed

If ultra-rapid acting insulins are used with normal delivery protocols, then the insulin acts even faster, but this exacerbates the delay time mismatch and causes more severe post-prandial blood glucose drops

Engineering Contradiction:
Improveinsulin absorption speedVSAvoidblood glucose stability
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The patent applies preliminary action by delivering a reduced initial portion of the insulin bolus before the full effect of ultra-rapid acting insulin kicks in. This preliminary controlled delivery prevents the mismatch between insulin appearance in blood and food metabolism, while subsequent deliveries are timed to match the accelerated absorption profile of ultra-rapid insulins

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes delivery parameters specifically for ultra-rapid acting insulins, including shorter intervals between bolus deliveries, modified wave-shaped delivery patterns, and adjusted total bolus amounts. These parameter changes align the insulin delivery profile with the faster absorption and action characteristics of ultra-rapid insulins, maintaining blood glucose stability

Inventive Principle:
Principle #35Parameter changes

3Duration of action of moving object

If pramlintide or gastric emptying slowing agents are administered with rapid insulin bolus, then gastric emptying is slowed and food metabolism is delayed, but the rapid insulin delivery creates a mismatch causing post-prandial blood glucose drops

Engineering Contradiction:
Improvegastric emptying timeVSAvoidpost-prandial blood glucose drop
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent implements feedback mechanisms that monitor blood glucose levels and adjust insulin delivery in real-time. When pramlintide or similar agents are administered, the system receives feedback about the slowed gastric emptying and adjusts the insulin bolus delivery parameters accordingly, extending the delivery period and reducing initial bolus amount to match the delayed food metabolism

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent applies preliminary anti-action by anticipating the delayed food metabolism caused by pramlintide and counteracting it with a modified insulin delivery protocol. The system delivers a reduced initial insulin portion and extends subsequent deliveries to match the slowed gastric emptying rate, preventing the harmful mismatch before it occurs

Inventive Principle:
Principle #9Preliminary anti-action

Data Source

PatentUS20250195753A1Method and device utilizing medicament delivery protocols
Publication Date: 2025.06.19 TANDEM DIABETES CARE INC
  • US20250195753A1 patent drawing
  • US20250195753A1 patent drawing
  • US20250195753A1 patent drawing

AI summary

A method of infusing liquid medicaments including insulin via an insulin pump, includes identifying an insulin delivery protocol associated with ingestion of carbohydrates wherein the insulin delivery protocol is likely to lead to a postprandial drop in blood glucose to a level below a basal level, then proposing at least one alternative insulin delivery protocol to inhibit the postprandial drop in blood glucose by delivering a metered amount of insulin that is appropriate to facilitate the metabolism of the carbohydrates without the postprandial blood glucose level drop. The invention further includes querying the patient as to whether to apply the alternative insulin delivery protocol, receiving instructions from the patient in response to the query, and applying the alternative insulin delivery protocol following receiving instructions from the patient to apply the alternative insulin delivery protocol.