Hypoglossal Nerve Stimulation for Sleep Apnea

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Solution Overview

Problem

Current methods for treating sleep disordered breathing, such as obstructive sleep apnea, often require external sensors and stimulate the hypoglossal nerve only after upper airway occlusion occurs, which is not preventative and has limitations in effectiveness and patient tolerance.

Innovation Solution

A method and apparatus that monitor the hypoglossal nerve for a pre-inspiratory drive signal to predictively stimulate the nerve before airway occlusion, using an implantable cuff with monitoring and stimulating contacts, and a controller to initiate electrical stimulation based on detected signals, without the need for external sensors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the hypoglossal nerve is stimulated only after upper airway occlusion occurs, then the treatment responds to actual apnea events, but it cannot prevent occlusions from occurring and has limited effectiveness

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidresponse time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system detects pre-inspiratory drive signals from the hypoglossal nerve before actual airway occlusion occurs and delivers stimulation in advance. This preliminary action allows the treatment to prevent apnea events rather than merely responding to them after they have occurred, thereby improving both effectiveness and response time.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If external sensors are used to monitor for stimulation, then the system can detect airway occlusion, but the device complexity increases and patient tolerance decreases

Engineering Contradiction:
Improveocclusion detection accuracyVSAvoidsensor requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system uses the hypoglossal nerve's own pre-inspiratory drive signals as the monitoring mechanism, eliminating the need for separate external sensors. The nerve signal itself serves as both the stimulation trigger and the monitoring parameter, thereby reducing device complexity while maintaining precise detection capability.

Inventive Principle:
Principle #25Self-service

3Reliability

If continuous monitoring and stimulation are implemented, then preventive treatment is achieved, but energy consumption increases

Engineering Contradiction:
Improvepreventive treatment efficacyVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system monitors for periodic pre-inspiratory drive signals that occur with each breathing cycle and delivers stimulation only when these signals are detected, rather than continuous stimulation. This periodic action maintains preventive treatment efficacy while significantly reducing energy consumption compared to continuous monitoring and stimulation.

Inventive Principle:
Principle #19Periodic action

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

Preventive stimulation of the hypoglossal nerve before occlusion occurs, potentially improving treatment efficacy and patient tolerance by addressing the root cause of airway obstruction during sleep, reducing complications associated with existing therapies.

Implementation Method 1

monitoring the hypoglossal nerve for a pre-inspiratory drive signal by sensing electroneurogram activity of the hypoglossal nerve

Methodology Applied
Scientific EffectElectroneurogram sensing:

Implementation Method 2

electrically stimulating the hypoglossal nerve in response to the detected pre-inspiratory drive signal to prevent occlusion of the patient's upper airway

Methodology Applied
Scientific EffectElectrical stimulation:

Data Source

PatentUS8024044B2Method and apparatus for hypoglossal nerve stimulation
Publication Date: 2011.09.20 KONINKLIJKE PHILIPS NV
  • US8024044B2 patent drawing
  • US8024044B2 patent drawing
  • US8024044B2 patent drawing

AI summary

A method of treating sleep disordered breathing in a patient includes the steps of monitoring the patient for a pre-inspiratory drive signal indicative of the breathing cycle by sensing electroneurogram activity of a hypoglossal nerve of the patient; and electrically stimulating the hypoglossal nerve of the patient following each detection of the pre-inspiratory drive signal. An implantable apparatus for stimulating a hypoglossal nerve of a patient for the treatment of sleep disordered breathing includes an electrode positioned at least partially around the hypoglossal nerve with a monitoring contact and a stimulation contact and a controller operatively coupled to the monitoring contact and the stimulation contact. The monitoring contact monitors the electroneurogram activity of the hypoglossal nerve for a pre-inspiratory drive signal indicative of the onset of inspiration and sends a signal to the controller which in turn causes the stimulating electrode to electrically stimulate the hypoglossal nerve.