External Control Unit for Nerve Modulation

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Solution Overview

Problem

Current treatments for sleep-related breathing disorders like obstructive sleep apnea and snoring are invasive or ineffective, and there is a need for a more efficient method to modulate nerves to address these conditions without significant adverse effects.

Innovation Solution

A system comprising an implantable unit and an external control unit that uses energy delivery to modulate nerves, specifically the hypoglossal nerve, through a primary and secondary antenna configuration, allowing for real-time feedback and adjustment of nerve stimulation to prevent airway obstruction and alleviate symptoms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional treatments for sleep apnea are used, then airway obstruction can be addressed, but the treatments are invasive or ineffective with significant adverse effects

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidadverse effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical/invasive treatment systems with a neural modulation system that uses electrical stimulation delivered via implantable electrodes to the hypoglossal nerve. This substitutes traditional mechanical airway support (like CPAP masks) or surgical interventions with a bioelectric control system that naturally activates airway dilator muscles during sleep, eliminating the need for external mechanical devices and their associated discomfort and side effects.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If neural modulation is applied to modulate the hypoglossal nerve, then breathing patterns improve and sleep apnea events reduce, but the system requires complex implantable and external control components

Engineering Contradiction:
Improvebreathing pattern improvementVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system is divided into distinct functional modules: an implantable unit containing electrodes and a power source implanted near the hypoglossal nerve, and an external control unit that generates and transmits modulation signals wirelessly. This segmentation allows the complex control functions to be housed externally while the implantable portion remains relatively simple, facilitating easier implantation and maintenance while achieving effective neural modulation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a wireless communication intermediary that transmits modulation signals from the external control unit to the implantable unit without requiring physical connections. This intermediary system (using electromagnetic fields or other wireless transmission methods) simplifies the interface between the external controller and the implanted device, eliminating the need for complex wired connections while maintaining precise control over neural stimulation parameters.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If real-time feedback and adjustment of nerve stimulation is implemented, then treatment precision increases, but the system requires additional monitoring and control mechanisms

Engineering Contradiction:
Improvenerve stimulation precisionVSAvoidmonitoring and control mechanisms
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system incorporates feedback mechanisms where the external control unit monitors the patient's breathing patterns, sleep stages, and response to neural stimulation in real-time. Based on this feedback, the control unit automatically adjusts the modulation signal parameters (frequency, amplitude, pulse width) to optimize airway patency while minimizing unnecessary stimulation. This closed-loop control ensures precise and adaptive treatment without requiring complex manual intervention.

Inventive Principle:
Principle #23Feedback

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 reduces sleep apnea events and snoring by modulating the hypoglossal nerve, improving breathing patterns and reducing daytime somnolence, while being adaptable for various nerve modulation applications beyond sleep disorders.

Implementation Method 1

transmission of a modulation signal from the primary antenna to a secondary antenna associated with an implant unit

Methodology Applied
Scientific EffectElectromagnetic radiation: Electromagnetic Induction

Data Source

PatentUS11642534B2Programmable external control unit
Publication Date: 2023.05.09 NYXOAH
  • US11642534B2 patent drawing
  • US11642534B2 patent drawing
  • US11642534B2 patent drawing

AI summary

A medical device control unit is provided. The control unit may include a communications interface, a memory, and at least one processing device. The processing device may be configured to cause application of a control signal to a primary antenna associated with a unit external to a subject's body. The processing device may further be configured to monitor a feedback signal indicative of the subject's breathing and store, in the memory, information associated with the feedback signal. The processing device may also cause transmission of the stored information, via the communications interface, to a location remote from the control unit. The processing device may further be configured to receive an update signal, from the location remote from the control unit, and cause application of an updated control signal to the primary antenna based on the update signal.