Devices and/or methods for treating sleep disordered breathing may include stimulation of a single nerve, multiple nerves, as well as other tissues relating to upper airway patency.

A system for treatment of obstructive sleep apnea (OSA) is described. The system includes an introducer needle having an elongated body. The introducer needle is configured to create an opening in a tongue of a patient for implantation of a lead for treating OSA. One or more electrically conductive areas are located on the elongated body. A medical device is configured to deliver a stimulation signal via the introducer needle through the one or more electrically conductive areas to the tongue of the patient to stimulate one or more motor points of a protrusor muscle within the tongue of the patient.

In an example, the disclosure describes a system with a lead having a proximal end and a distal end and an elongated lead body. The lead has one or more electrodes. A fixation member is located on the elongated lead body and is configured to secure the lead to tissue within a patient. The fixation member is located on the lead so the fixation member is closer to the proximal end than the one or more electrodes of the lead. A trialing adaptor receives the proximal end of the lead and is removable when a trialing period is completed. A sheath encloses at least a portion of the lead and covers the fixation member. The sheath is configured to remain in place over the lead during the trialing period.

Hyolaryngeal suspension devices and systems for treating sleep disordered breathing (SDB) are provided. A device includes a first fastener sized and configured to anchor to a hyoid bone or thyroid cartilage of the patient and a second fastener is sized and configured to anchor to the sternum, clavicle, or ribs of the patient. A static or elastic member has one end connected to the first fastener and an opposing end connected to the second fastener. The elastic member has sufficient elasticity to allow the pharynx and/or the larynx to elevate dynamically to permit speech and swallowing. The static member has sufficient tension to maintain appropriate haryngeal wall tension while still permitting sufficient movement of the hyoid bone and thyroid cartilage for speech and swallowing function.

One example of an implantable medical device includes an output signal driver, a first electrode, a second electrode, and a controller. The output signal driver is configured to generate stimulation pulses to stimulate a nerve within a patient. The first electrode is coupled to the output signal driver. The second electrode is coupled to the output signal driver. The controller is configured to control the output signal driver to selectively apply between the first electrode and the second electrode a first pulse train and a second pulse train interleaved with the first pulse train.

One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

An oral appliance for treating sleep apnea in a user includes a mouthpiece configured for being positioned in an oral cavity of the user, and at least one pulse oximeter attached to the mouthpiece. According to an aspect, the pulse oximeter is configured to monitor actual oxygen saturation levels of hemoglobin of the user when the oral appliance is positioned in the oral cavity of the user. The oral appliance may include an additional sensor attached to the mouthpiece that includes at least one of an airflow sensor, a pressure sensor, a noise detector, and an actigraphy sensor.

Neuromodulation of cranial nerves can be used to treat sleep or breathing disorders, among other diseases and disorders. A neuromodulation system can include a housing configured for implantation in an anterior cervical region of a patient, such as at or under a mandible of the patient, such as at least partially in one or more of a submental triangle, a submandibular triangle, and a carotid triangle. The system can include an electrode lead coupled to the housing, and the electrode lead can include an electrode configured to be disposed at or near a cranial nerve target in the patient. The system can be configured to generate electrical neuromodulation signals for delivery to the cranial nerve target using the electrode.

Devices, systems and methods for treating bronchial constriction related to asthma, anaphylaxis or chronic obstructive pulmonary disease wherein the treatment includes stimulating selected nerve fibers responsible for smooth muscle dilation at a selected region within a patient's neck, thereby reducing the magnitude of constriction of bronchial smooth muscle.

An oral appliance for the treatment of sleep disorders, such as obstructive sleep apnea, in a user is presented. The oral appliance may include a mouthpiece configured to receive a user's dentition. The mouthpiece may include an oxygen sensor, a pressure sensor, an airflow sensor, an actigraphy sensor, a noise detector, and at least one stimulator for providing stimulation to a user's tongue in the event of decreased oxygen saturation levels, increased pressure applied to occlusal surfaces of the user's dentition, decreased actual airflow levels and/or increased noise levels. The mouthpiece may further include a microprocessor that receives data from the oxygen sensor, pressure sensor, airflow sensor, actigraphy sensor and noise detector, and activates the at least one stimulator.