Stimulation For Treating Sleep Disordered Breathing

Patent No. US11806526 (titled "Stimulation For Treating Sleep Disordered Breathing") was filed by Inspire Medical Systems Inc on Sep 4, 2020.

’526 is related to the field of medical devices, specifically devices and methods for treating obstructive sleep apnea (OSA). The background of the invention acknowledges that targeted electrical stimulation of nerves, such as the hypoglossal nerve, can help maintain upper airway patency and alleviate OSA. However, prior approaches may have limitations in terms of cost, complexity, and potential muscle fatigue.

The underlying idea behind ’526 is to provide a system for treating OSA using electrical stimulation of an airway-patency-related nerve, such as the hypoglossal nerve, without necessarily synchronizing the stimulation to the patient's breathing pattern. The key inventive insight is that asynchronous stimulation, delivered in alternating periods of stimulation and non-stimulation, can effectively maintain airway patency without requiring complex sensing and synchronization mechanisms. This is achieved by ensuring that the stimulation periods overlap with the inspiratory phase of the respiratory cycle for a significant portion of the treatment period, even if the stimulation is not triggered by the inspiratory phase itself.

The claims of ’526 focus on a device for treating OSA that includes a non-cardiac stimulation means for stimulating an upper airway patency-related nerve. This stimulation means comprises an implantable electrode and/or an implantable pulse generator that delivers electrical stimulation according to a first stimulation therapy protocol. This protocol involves alternating stimulation periods and non-stimulation periods, where the timing of the stimulation periods is asynchronous relative to the patient's breathing. The duration of each stimulation period is greater than the duration of each non-stimulation period, and is based on a reference respiratory-related parameter.

In practice, the device delivers electrical pulses to the target nerve according to a pre-programmed protocol. The protocol defines the duration of the stimulation and non-stimulation periods, as well as the amplitude and frequency of the electrical pulses. The asynchronous nature of the stimulation means that the device does not need to sense the patient's breathing in real-time to trigger the stimulation. Instead, it relies on a reference respiratory-related parameter, such as the average duration of a respiratory cycle, to determine the timing of the stimulation periods. This simplifies the design and reduces the cost of the device.

The invention differentiates itself from prior approaches by eliminating the need for real-time respiratory sensing and synchronization. This reduces the complexity and cost of the device, and also makes it easier to implant and operate. Furthermore, the alternating periods of stimulation and non-stimulation help to minimize potential muscle fatigue. By providing asynchronous stimulation, the device can also overcome situations where sensor-based systems are unable to achieve synchronization or the sensing signal becomes unstable. The patent also contemplates rotating through different stimulation protocols to optimize therapy and address varying patient needs.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’526 was filed, targeted electrical stimulation was being explored for various therapies, at a time when implantable medical devices were becoming more sophisticated, and when systems commonly relied on sensing physiological parameters to control stimulation, but hardware or software constraints made asynchronous stimulation protocols non-trivial.

Novelty and Inventive Step

The examiner allowed the claims because they found that the prior art did not disclose a stimulation therapy protocol that included alternating stimulation and non-stimulation periods where the timing of the stimulation periods was asynchronous relative to patient breathing. While some prior art used asynchronous stimulation, it was not used as a therapy for sleep apnea, nor did it disclose basing the duration of each stimulation period on a respiratory-related parameter.

Claims

This patent contains 23 claims, with independent claims numbered 1, 16, and 22. The independent claims are directed to a device for treating obstructive sleep apnea using non-cardiac stimulation of an upper airway nerve with specific stimulation protocols. The dependent claims generally elaborate on and refine the specifics of the device and stimulation protocols described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)	Support for Specification	Interpretation
Asynchronous relative to patient breathing (Claim 1, Claim 16, Claim 22)	“In some examples, the independent stimulation element is configured to asynchronously stimulate an airway-patency-related nerve, according to a first stimulation protocol independent of sensed respiratory information and in which each stimulation cycle includes a stimulation period and a non-stimulation period. In some instances, the first stimulation protocol is referred to as being independent because the first stimulation protocol is not synchronized relative to sensed respiratory information. In some instances, the independence of the first stimulation protocol also may be referred to as being an asynchronous stimulation protocol because the first stimulation protocol is not synchronized relative to the sensed respiratory information.”	The timing of the stimulation periods is not synchronized with the patient's breathing pattern.
First stimulation therapy protocol (Claim 1, Claim 16, Claim 22)	“In some examples, the independent stimulation element is configured to asynchronously stimulate an airway-patency-related nerve, according to a first stimulation protocol independent of sensed respiratory information and in which each stimulation cycle includes a stimulation period and a non-stimulation period. In some instances, the first stimulation protocol is referred to as being independent because the first stimulation protocol is not synchronized relative to sensed respiratory information. In some instances, the independence of the first stimulation protocol also may be referred to as being an asynchronous stimulation protocol because the first stimulation protocol is not synchronized relative to the sensed respiratory information.”	A stimulation protocol that includes alternating stimulation periods and non-stimulation periods, where the timing of the stimulation periods is asynchronous relative to patient breathing.
Non-stimulation periods (Claim 1, Claim 16, Claim 22)	“In some examples, the independent stimulation element is configured to asynchronously stimulate an airway-patency-related nerve, according to a first stimulation protocol independent of sensed respiratory information and in which each stimulation cycle includes a stimulation period and a non-stimulation period. In some instances, the first stimulation protocol is referred to as being independent because the first stimulation protocol is not synchronized relative to sensed respiratory information. In some instances, the independence of the first stimulation protocol also may be referred to as being an asynchronous stimulation protocol because the first stimulation protocol is not synchronized relative to the sensed respiratory information.”	Periods of time during which the upper airway patency-related nerve is not stimulated.
Stimulation periods (Claim 1, Claim 16, Claim 22)	“In some examples, the independent stimulation element is configured to asynchronously stimulate an airway-patency-related nerve, according to a first stimulation protocol independent of sensed respiratory information and in which each stimulation cycle includes a stimulation period and a non-stimulation period. In some instances, the first stimulation protocol is referred to as being independent because the first stimulation protocol is not synchronized relative to sensed respiratory information. In some instances, the independence of the first stimulation protocol also may be referred to as being an asynchronous stimulation protocol because the first stimulation protocol is not synchronized relative to the sensed respiratory information.”	Periods of time during which the upper airway patency-related nerve is stimulated.
Upper airway patency-related nerve (Claim 1, Claim 16, Claim 22)	“Targeted electrical stimulation of a nerve shows great promise in a number of therapies. In one example, such stimulation of a hypoglossal nerve is known to alleviate obstructive sleep apnea by helping to maintain and/or restore upper airway patency. By doing so, upper airway patency may be maintained and/or increased while preventing or minimizing collapse of the upper airway.”	A nerve whose stimulation helps maintain and/or restore the openness of the upper airway, thereby alleviating obstructive sleep apnea.

Litigation Cases New

US Latest litigation cases involving this patent.

Case Number	Filing Date	Title
1:25-cv-00667	May 30, 2025	Inspire Medical Systems, Inc. V. Nyxoah, Inc.

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US11806526

INSPIRE MEDICAL SYSTEMS INC

Application Number: US17012481
Filing Date: Sep 4, 2020
Status: Granted
Expiry Date: Apr 23, 2037
External Links: Slate, USPTO, Google Patents

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