Methods for treatment of sleep apnea

Patent No. US9415215 (titled "Methods for treatment of sleep apnea") on Oct 16, 2015. The application was issued on Aug 16, 2016.

'215 is related to the field of neuromodulation, specifically addressing devices and methods for communicating between an implantable device and an external unit. The background involves treating physiological conditions and disorders by interacting with the body's nervous system, including motor neuron stimulation, sensory neuron blockage, and autonomic nervous system modulation. Examples include treating obstructive sleep apnea (OSA), migraine headaches, and hypertension, where neural modulation can improve breathing, relieve pain, and regulate blood pressure, respectively.

The underlying idea behind '215 is to provide a system for selectively modulating nerves using an implanted device powered and controlled by an external unit. The key inventive insight is to regulate the power delivered to the implant based on the degree of coupling between the external and implanted antennas. This allows for efficient and targeted nerve modulation, minimizing power consumption and maximizing therapeutic effect.

The claims of '215 focus on methods for treating sleep apnea by receiving a modulation signal at an implant unit located on the underside of the chin. The signal is applied to electrodes to generate an electric field, causing modulation of the hypoglossal nerve. This modulation is confined to the medial branch of the hypoglossal nerve, initiated from a single modulation site, or causes contractions of the genioglossus muscle without affecting other tongue muscles.

In practice, the external unit transmits a signal to the implanted unit, and the implant generates an electric field to stimulate the targeted nerve. The external unit monitors the coupling between its antenna and the implant's antenna, adjusting the power level to ensure effective nerve modulation. This feedback mechanism allows the system to adapt to changes in the implant's position or the patient's physiology, maintaining optimal therapeutic delivery.

This approach differs from prior solutions by providing a closed-loop system that dynamically adjusts power delivery based on the degree of coupling between the external and implanted units. This contrasts with open-loop systems that deliver a fixed amount of power regardless of the actual coupling efficiency. By monitoring the degree of coupling, the system can also detect changes in the implant's position or the patient's condition, allowing for more precise and adaptive nerve modulation.

How does this patent fit in bigger picture?

Technical Landscape

In the late 2000s when ’215 was filed, neural modulation systems were typically implemented using bulky, invasive hardware that often required direct physical contact between electrodes and the target nerve. At a time when systems commonly relied on high-current stimulation to ensure efficacy, the engineering constraints of power delivery and heat dissipation made low-power, wireless energy transfer to deep-tissue implants non-trivial. Furthermore, the technical landscape was characterized by a reliance on multi-site stimulation arrays, as achieving precise nerve modulation from a single, remote location was difficult to implement within the battery and signal processing limitations of the era.

Prosecution Position

The examiner allowed the application because the cited prior art failed to teach a specific configuration for nerve modulation. While previous technologies described general electrical stimulation, they did not disclose a system where the electrical signals are designed to trigger nerve modulation from a single, specific site located along the medial branch of the nerve. The combination of existing methods did not reach this specific technical implementation of initiating modulation at one precise point.

Claims

This patent contains 20 claims, of which claims 1, 8, and 14 are independent. The independent claims focus on methods for treating sleep apnea by modulating the hypoglossal nerve using an implanted device. The dependent claims generally specify details and limitations to the methods described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)	Support for Specification	Interpretation
Electric field (Claim 1, Claim 8)	Neural modulation includes inhibition (e.g. blockage), stimulation, modification, regulation, or therapeutic alteration of activity, electrical or chemical, in the central, peripheral, or autonomic nervous system.	A field generated by the electrodes that causes modulation of the hypoglossal nerve.
Genioglossus muscle (Claim 8)	The largest of the pharyngeal muscles responsible for upper airway dilation is the genioglossus muscle, which is one of several different muscles in the tongue. The genioglossus muscle is responsible for forward tongue movement and the stiffening of the anterior pharyngeal wall.	A muscle in the tongue that is contracted in response to the electric field.
Hypoglossal nerve (Claim 1, Claim 8, Claim 14)	In patients with OSA, the neuromuscular activity of the genioglossus muscle is decreased compared to normal individuals, accounting for insufficient response and contraction to open the airway as compared to a normal individual.	A nerve that is modulated to treat sleep apnea.
Medial branch (Claim 1, Claim 14)	The largest of the pharyngeal muscles responsible for upper airway dilation is the genioglossus muscle, which is one of several different muscles in the tongue. The genioglossus muscle is responsible for forward tongue movement and the stiffening of the anterior pharyngeal wall.	A specific branch of the hypoglossal nerve that is targeted for modulation.
Modulation signal (Claim 1, Claim 8, Claim 14)	Neural modulation includes inhibition (e.g. blockage), stimulation, modification, regulation, or therapeutic alteration of activity, electrical or chemical, in the central, peripheral, or autonomic nervous system.	A signal received by the implant unit and applied to electrodes to generate an electric field for nerve modulation.

Litigation Cases New

US Latest litigation cases involving this patent.

Case Number	Filing Date	Title
1:25-cv-01147	Sep 15, 2025	Nyxoah SA et al. v. Inspire Medical Systems, Inc.

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US9415215

Application Number: US14884964A
Filing Date: Oct 16, 2015
Publication Date: Aug 16, 2016
External Links: Slate, USPTO, Google Patents

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