Hypoglossal Nerve Stimulation Programming for Faster OSA Acclimation
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Solution Overview
Problem
Existing treatments for moderate to severe obstructive sleep apnea, such as CPAP and surgical interventions, suffer from low compliance, discomfort, and high complication rates, while hypoglossal nerve stimulation requires lengthy acclimation periods.
Innovation Solution
A system and method for hypoglossal nerve stimulation using a Smart Wireless Implantable Pulse Generator (SWIPG) with adjustable stimulation parameters, including electrodes and a communication module, to selectively activate the hypoglossal nerve and treat obstructive sleep apnea.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hypoglossal nerve stimulation is used to treat moderate to severe OSA, then treatment efficacy is improved, but acclimation period is extended up to 6 months
Solution Approach 1:
The patent applies preliminary action by pre-programming multiple stimulation parameters (pulse width, frequency, amplitude, duty cycle) into the implantable device before patient use. This allows the device to systematically explore different stimulation configurations without requiring lengthy manual adjustments, thereby reducing the acclimation period while maintaining treatment efficacy.
Solution Approach 2:
The patent implements dynamics by enabling the stimulation parameters to be dynamically adjusted and modified based on patient response and comfort levels. The system allows real-time programming changes during the acclimation process, adapting the stimulation regimen to achieve both therapeutic effect and patient tolerance more quickly.
2Reliability
If traditional surgical interventions are used to remove soft tissue and remodel the back of the throat, then airway obstruction is reduced, but invasiveness and complication rate increase
Solution Approach 1:
The patent replaces mechanical surgical intervention with electrical nerve stimulation. Instead of physically removing or remodeling throat tissue through surgery, the system uses electrical impulses delivered via the hypoglossal nerve to maintain airway patency, thereby eliminating surgical invasiveness and associated complications while achieving similar therapeutic outcomes.
Solution Approach 2:
The patent introduces an intermediary mechanism - the hypoglossal nerve stimulation system - that mediates between the need for airway patency and the desire to avoid surgery. The implantable device acts as an intermediary that delivers controlled electrical stimulation to prevent tongue collapse and maintain airway opening without requiring direct surgical alteration of the airway structures.
3Reliability
If CPAP is used as first line treatment for moderate-to-severe OSA, then Apnea-Hypopnea Index is reduced, but compliance decreases between 29% and 83%
Solution Approach 1:
The patent extracts the compliance problem by removing the need for patient cooperation required by CPAP masks. The implantable hypoglossal nerve stimulation device operates autonomously without requiring patient intervention or adherence to mask-wearing protocols, thereby eliminating the primary source of non-compliance while maintaining effective OSA treatment.
Solution Approach 2:
The patent implements self-service by designing an implantable device that automatically delivers therapeutic stimulation without requiring patient activation or compliance. The system serves itself by autonomously monitoring and responding to respiratory events, eliminating the need for patient participation that plagues CPAP therapy and thereby improving compliance to near 100%.
Data Source
AI summary
Systems and methods for hypoglossal nerve stimulation. Certain embodiments include a pulse generator, circuitry configured to receive an energy signal, a communication module, and a programming module. In certain embodiments, the first pulse generator comprises a first electrode and a second electrode, a pulse generator coil, and circuitry configured to receive an energy signal. In particular embodiments, the first pulse generator can be configured to be implanted directly on a hypoglossal nerve on a first side of the patient and configured to deliver stimulation energy to activate at least one branch of the hypoglossal nerve on the first side of the patient. The communication module can include a communication coil configured to communicate with the pulse generator coil in specific embodiments. The programming module can be configured to communicate programming instructions to the communication module, the programming instructions defining an attribute of the stimulation energy.