US 11850424

US patent 11850424, titled "Stimulation for treating sleep disordered breathing," was granted to Inspire Medical Systems, Inc.. The inventors are Darrell Wagner, Quan Ni, John Rondoni, and David Dieken. The patent was filed on June 16, 2021, and issued on December 26, 2023.

Abstract:
A device for treating sleep disordered breathing includes a stimulation element designed to stimulate a nerve related to maintaining airway patency. The abstract further states that the stimulation element applies nerve stimulation using a first stimulation protocol that is not synchronized with sensed respiratory information. Each stimulation cycle within this protocol includes a period of stimulation and a period of non-stimulation.

Litigation Status:
As of the current date, an Inter Partes Review (IPR) case, IPR2026-00092, was filed on December 18, 2025, challenging patent US11850424. The status of this IPR case is "Not Instituted - Procedural". Additionally, a US case has been filed in the Delaware District Court, although specific details regarding its nature are not provided in the readily available information.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim describes a method for treating sleep-disordered breathing. It involves applying nerve stimulation to an airway-patency-related nerve using a stimulation protocol that is not synchronized with real-time sensed respiratory information. The stimulation protocol consists of repeating stimulation cycles, each having a period of continuous stimulation followed by a period of no stimulation. The duration of the continuous stimulation period is less than the duration of a patient's reference respiratory cycle but greater than the inspiratory phase of that reference cycle. The non-stimulation period is shorter than the stimulation period. The design ensures that for a significant majority of a treatment period, the stimulation periods will overlap with at least part of the inspiratory phase of successive reference respiratory cycles.

• Independent Claim 12: This claim outlines a system for treating sleep-disordered breathing. The system includes an implantable pulse generator (IPG) with a stimulation element and a communication element. The stimulation element is configured to apply nerve stimulation using a first stimulation protocol that is not synchronized with sensed respiratory information, where each stimulation cycle has a stimulation period and a non-stimulation period. The system also includes a therapy manager (either within the IPG or in communication with it) that causes the stimulation element to operate according to this first stimulation protocol. The therapy manager can initiate or terminate nerve stimulation based on whether the patient is likely to be experiencing or is experiencing apneas.

• Independent Claim 13: This claim details a method for treating sleep-disordered breathing that involves converting between different stimulation modes. The method includes operating in a first stimulation mode for a predetermined period. This first mode involves stimulating an airway-patency-related nerve using a protocol that is not synchronized with sensed respiratory information. The method then automatically converts to a second stimulation mode, where stimulation is synchronized with a characteristic of the sensed respiratory waveform, but only if the sensed respiratory waveform meets a certain sensor signal quality criteria. If the sensor signal quality criteria are no longer met, the system automatically reverts back to the first (asynchronous) stimulation mode.

• Independent Claim 14: This claim also describes a method for treating sleep-disordered breathing with convertible stimulation modes. However, in this claim, the system defaults to the second (synchronous) stimulation mode. If at least one parameter of the sensed respiratory waveform fails to meet a sensor signal quality criterion, the operation converts to the first (asynchronous) stimulation mode. Then, when the sensed respiratory waveform again meets the sensor signal quality criteria, the operation reverts to the second (synchronous) stimulation mode.