Implantable Pulse Generator Feedback for Vagal Glycemic Control

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Solution Overview

Problem

Type 2 diabetes is challenging to treat effectively due to prolonged deviations in blood sugar levels, leading to complications, and self-managed treatments face compliance issues, with existing therapies failing to maintain glycemic control efficiently.

Innovation Solution

An implantable pulse generator system that monitors patient feedback, adjusts current parameters based on glucose levels, exercise, and meal activity, and applies electrical stimulation/blocking therapy to vagal trunks to mute glycemic responses, using cuff electrodes for vagus nerve stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If self-managed diabetes treatment is used, then treatment flexibility is improved, but compliance and adherence deteriorate

Engineering Contradiction:

Improvetreatment flexibilityVSAvoidcompliance and adherence

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The system enables self-service by having the implantable pulse generator automatically monitor glucose levels and adjust stimulation parameters without requiring patient intervention. The device autonomously manages diabetes treatment based on real-time glucose data, eliminating the need for manual monitoring and injection decisions while maintaining treatment flexibility.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system implements closed-loop feedback by continuously monitoring glucose levels through the implantable sensor and automatically adjusting the electrical stimulation parameters of the pulse generator based on the glucose readings. This feedback mechanism ensures reliable compliance while adapting to changing glycemic conditions.

Inventive Principle:

Principle #23Feedback

2Reliability

If continuous monitoring and adjustment of therapy is implemented, then glycemic control is improved, but device complexity increases

Engineering Contradiction:

Improveglycemic controlVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system merges multiple functions into a single integrated implantable device that combines the pulse generator, glucose sensor, processor, and communication module. By consolidating these components, the device achieves continuous monitoring and adjustment capabilities without proportionally increasing overall system complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The implantable pulse generator is designed as a multi-functional device that simultaneously performs glucose monitoring, electrical stimulation, and data communication. This universal design allows continuous glycemic control through a single device rather than requiring separate systems for monitoring and treatment.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If electrical stimulation is applied to vagal trunks, then glycemic response is muted, but potential harmful effects on the nerve may occur

Engineering Contradiction:

Improveglycemic controlVSAvoidnerve damage risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system dynamically adjusts electrical stimulation parameters including amplitude, frequency, and pulse width based on real-time glucose levels and response patterns. The processor continuously optimizes stimulation intensity to achieve glycemic control while staying within safe thresholds to prevent nerve damage, adapting the electrical parameters to minimize harmful effects.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The implantable pulse generator changes electrical parameters such as current amplitude, pulse duration, and frequency based on glucose measurements and patient response. By continuously adjusting these parameters, the system achieves effective glycemic control while maintaining stimulation levels that are high enough to mute glycemic responses but low enough to avoid nerve damage.

Inventive Principle:

Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system effectively maintains glycemic control, reduces postprandial glycemic peaks, improves insulin sensitivity, and enhances patient comfort and safety by automatically adjusting therapy based on real-time feedback.

Implementation Method 1

an implantable pulse generator configured to generate a current; an electrode configured to apply the current to an anatomical element

Methodology Applied

Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS20250295924A1Systems and methods for monitoring and controlling an implantable pulse generator

Publication Date: 2025.09.25 MEDTRONIC INC

AI summary

Systems and methods for monitoring an implantable pulse generator are provided. The system may comprise an implantable pulse generator configured to generate a current and an electrode configured to apply the current to an anatomical element. Patient feedback may be monitoring using at least one device and an activation signal may be generated based on the patient feedback. The activation signal may be transmitted to the implantable pulse generator to cause the implantable pulse generator to generate the current, thereby causing the electrode to apply the current to the anatomical element.