Closed-Loop Hypoglossal Stimulation for OSA Airway Patency
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Solution Overview
Problem
Existing treatments for obstructive sleep apnea (OSA), such as CPAP and invasive neurostimulation, suffer from poor patient compliance and invasive surgical risks, while noninvasive neurostimulation methods fail to effectively activate the genioglossus muscle due to inaccurate electrode placement and stimulation levels.
Innovation Solution
A non-invasive neurostimulation device with a patch or oral appliance containing uniformly spaced electrodes that monitor GG muscle activity through EMG signals, providing real-time feedback to determine optimal electrode placement and stimulation levels for effective GG muscle activation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If CPAP is used to treat OSA, then airway patency is improved, but patient compliance deteriorates due to intrusive nature and discomfort
Solution Approach 1:
The patent replaces the mechanical CPAP system with a neural stimulation system. Instead of using continuous positive airway pressure delivered through a mask and hose, the invention uses electrical stimulation of the hypoglossal nerve to activate the genioglossus muscle, thereby maintaining airway patency without the intrusive mechanical components of CPAP equipment.
Solution Approach 2:
The patent introduces an intermediary neural stimulation mechanism between the brain and the genioglossus muscle. By stimulating the hypoglossal nerve, the system acts as an intermediary that activates muscle contraction to maintain airway patency, replacing the direct mechanical pressure application of CPAP with a neurophysiological intermediary mechanism.
2Reliability
If invasive hypoglossal nerve stimulation is used, then OSA treatment effectiveness is improved, but surgical risk increases
Solution Approach 1:
The patent segments the stimulation function across multiple electrodes distributed along the hypoglossal nerve pathway. Instead of using a single invasive lead, the system employs an array of electrodes that can be positioned to stimulate the nerve at different locations, distributing the surgical intervention and reducing the risk associated with any single invasive site.
Solution Approach 2:
The patent implements dynamic stimulation parameters that can be adjusted in real-time. The system monitors muscle response and airway status, dynamically modifying stimulation intensity and duration to maintain effectiveness while minimizing tissue damage and surgical complications. This dynamic control reduces the harmful effects of invasive stimulation.
3Ease of operation
If noninvasive neurostimulation is used, then patient comfort is improved, but stimulation effectiveness deteriorates due to inaccurate electrode placement
Solution Approach 1:
The patent incorporates feedback mechanisms that monitor muscle response and airway status in real-time. The system uses this feedback to adjust electrode placement and stimulation parameters dynamically, ensuring that noninvasive electrode positions can achieve effective stimulation. The feedback loop compensates for variations in electrode placement to maintain stimulation reliability.
Solution Approach 2:
The patent employs parameter changes in stimulation intensity, frequency, and duration to compensate for noninvasive electrode placement variations. By dynamically adjusting these parameters based on real-time monitoring, the system maintains effective stimulation even when electrodes are not precisely positioned, bridging the gap between comfort and effectiveness.
4Reliability
If continuous stimulation is applied, then airway patency is maintained, but muscle fatigue increases
Solution Approach 1:
The patent implements periodic stimulation patterns rather than continuous stimulation. The system applies stimulation in controlled cycles, allowing the genioglossus muscle to rest during off-periods while maintaining airway patency during active periods. This periodic action prevents muscle fatigue while ensuring adequate airway support throughout the sleep cycle.
Solution Approach 2:
The patent uses dynamic stimulation parameters that adapt to muscle response and sleep stages. The system adjusts stimulation intensity, duration, and frequency in real-time based on monitored parameters, optimizing the balance between maintaining airway patency and preventing muscle fatigue. This dynamic control ensures stimulation is applied only when necessary and at appropriate levels.
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 device effectively maintains upper airway patency by accurately targeting and stimulating the genioglossus muscle, reducing OSA events without invasive surgery or discomfort, enhancing patient compliance and safety.
Implementation Method 1
monitor GG muscle activity through EMG signals
Implementation Method 2
stimulating the GG muscle... providing real-time feedback to determine optimal electrode placement and stimulation levels
Data Source
AI summary
Obstructive sleep apnea from blockage of the upper airway can result in significant daytime drowsiness, with many long-term co-morbidities associated with this disorder such as such as hypertension. A common cause of obstructive sleep apnea is the complete concentric collapse of the soft pallet or retrusion of the genioglossus muscle into the upper airway obstructing breathing. The latter can be due to exhaustion of the muscle due to heightened activation during wake periods, or a greater number of type II muscle fibers can contribute to muscle fatigue. It could also be neurological, whereby the hypoglossal nerve which controls most the upper airway muscles fails to innervate the genioglossus sufficiently to prevent backward movement and pharyngeal block. Described herein is an intelligent personalized closed loop neuromodulation system and methods to prevent backwards movement of the genioglossus muscle through stimulation of certain branches of the hypoglossal nerve and muscle motor points, by using muscle feedback from electromyogram sensors to provide optimal stimulus. Alternative embodiments to treat neuropathic pain and urinary dysfunction are enclosed.