Phrenic Nerve Stimulation Synchronized to Prevent Airway Collapse

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Solution Overview

Problem

Existing treatments for Obstructive Sleep Apnea (OSA) are limited in effectiveness due to insufficient reflex responses and neuromuscular control during sleep, leading to airway collapse and compromised breathing, with current methods like Hypoglossal Nerve stimulation having limited success.

Innovation Solution

The use of an implantable device to stimulate the phrenic nerve, leveraging the negative pressure reflex (NPR) to trigger rapid diaphragmatic contractions, synchronizing with the respiratory cycle to maintain airway patency and prevent collapse, combined with lung volume manipulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Hypoglossal Nerve stimulation is used to address airway collapsibility, then airway patency is improved, but treatment effectiveness is limited

Engineering Contradiction:

Improveairway patencyVSAvoidtreatment effectiveness

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the stimulation target from Hypoglossal Nerve to Phrenic Nerve, altering the physiological mechanism from direct tongue protrusion to diaphragmatic contraction. This parameter change enables more effective airway patency maintenance by leveraging the negative pressure reflex mechanism, which directly counters airway collapse forces during inspiration.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces the negative pressure reflex as an intermediary mechanism. Phrenic nerve stimulation triggers diaphragmatic contraction, which generates negative intrathoracic pressure, which in turn activates the negative pressure reflex to stiffen airway muscles. This intermediary mechanism provides a more robust and physiologically natural pathway for maintaining airway patency compared to direct hypoglossal nerve stimulation.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If lung volume is increased to improve airway patency, then airway stability is improved, but patient comfort deteriorates due to sleep disturbance

Engineering Contradiction:

Improveairway stabilityVSAvoidpatient comfort

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent employs periodic phrenic nerve stimulation synchronized with the respiratory cycle rather than continuous stimulation. By delivering stimulation bursts at specific phases of breathing (during inspiration or early expiration), the system maintains airway stability only when needed, allowing lung volume to return to normal during other phases, thereby preserving patient comfort and sleep quality.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The patent implements dynamic, phase-locked stimulation that adapts to the patient's natural breathing pattern. The stimulation timing and duration are adjusted based on respiratory phase detection, creating a dynamic therapy that responds to real-time physiological conditions rather than applying static, continuous lung volume expansion.

Inventive Principle:

Principle #15Dynamics

3Reliability

If phrenic nerve stimulation is used to trigger negative pressure reflex, then airway collapse is prevented, but stimulation timing must be precisely synchronized with respiratory cycle

Engineering Contradiction:

Improveairway collapse preventionVSAvoidstimulation timing control

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent incorporates respiratory phase detection feedback to control stimulation timing. Sensors monitor chest wall motion, airflow, or intrathoracic pressure to determine the current respiratory phase, and this feedback information is used to trigger phrenic nerve stimulation at the optimal moment. This closed-loop feedback system ensures precise synchronization without requiring complex open-loop timing algorithms.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent leverages the patient's own respiratory drive and natural breathing pattern to facilitate synchronization. The stimulation system detects and locks onto the patient's intrinsic respiratory rhythm, allowing the patient's own physiology to serve as the timing reference, thereby simplifying the control system while maintaining precise phase alignment.

Inventive Principle:

Principle #25Self-service

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

This approach effectively maintains airway stability by rapidly restoring pharyngeal muscle tone, reducing airway collapse, and preventing oxygen desaturation without arousing the patient, thus improving sleep quality and respiratory efficiency.

Implementation Method 1

stimulate the phrenic nerve, leveraging the negative pressure reflex (NPR) to trigger rapid diaphragmatic contractions

Methodology Applied

Scientific EffectNegative pressure reflex:

Implementation Method 2

use of an implantable device to stimulate the phrenic nerve

Methodology Applied

Scientific EffectElectrical stimulation:

Data Source

PatentUS20250352799A1System to treat sleep apnea by entraining stimulation with breathing

Publication Date: 2025.11.20 LUNAIR MEDICAL INC

AI summary

Techniques for addressing sleep disorders are provided. A system includes a nerve stimulator that is configured to deliver stimulation energy to a nerve of a sleeping patient. A system includes a sensor for gather data from the sleeping patient and a controller for processing the data. The controller is configured to cause the stimulation energy that is provided to be adjusted based on the sensed data.