The present disclosure provides generally for a therapeutic oral device for sleep apnea and associated methods for using the device. According to the present disclosure, the device may comprise a hard palate portion, mouth guard portion, and a tongue retainer portion. The hard palate portion may comprise one or more materials. The hard palate portion may also comprise a composite of materials, including but not limited to embedded materials. The mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral device within the mouth. The tongue retainer portion may comprise an airway and a predetermined length. A method of use may comprise the utilization of one or more incremental oral devices to overcome a gag reflex. When the oral device is formed from a mold, the mouth guard portion and the hard palate portion may be custom fit to the dimensions of the intended mouth.

Methods, devices, and systems are disclosed for controlled delivery of a therapy, such as a stimulant, to a mouth of a subject via an oral device positioned in a secured configuration in the mouth. At least one of a tongue position stimulator (TST) and tongue position sensor (TSE) is provided, according to certain aspects. According to another aspect, a stimulus is delivered to the mouth and/or tongue via a mouthpiece secured to the subject's teeth. In another regard, a stimulus is delivered that generates a natural response to eliminate or reduce sleep disorders, such as for example at least one of snoring and obstructive sleep apnea.

An anti-obstructive airway dental orthotic producing increased intraoral volume. A maxillary retainer is connected to a mandibular retainer by a strut having a length variable only between a fixed minimum and a fixed maximum length. The maxillary retainer has two pivot points such that the strut may be moved from the second pivot point to the first pivot point (to effect a progressive adjustment of mandibular advance. The maxillary retainer may be provided with a spacing area that creates a minimum vertical separation between a cusp of the user's maxillary premolar and a cusp of the user's opposing mandibular premolar. The spacing area provides additional space over the prior art for a lateral expansion of the tongue, which increase intraoral airway volume and eases obstructive sleep apnea. Methods for the attenuation of obstructive sleep apnea (OSA) and for decreasing perioperative morbidity and mortality among OSA patients are described.

An implant unit configured for implantation into a body of a subject is provided. The implant unit may include a flexible carrier unit including a central portion and two elongated arms extending from the central portion, an antenna, located on the central portion, configured to receive a signal, at least one pair of electrodes arranged on a first elongated arm of the two elongated arms. The at least one pair of electrodes may be adapted to modulate a first nerve. The elongated arms of the flexible carrier may be configured to form an open ended curvature around a muscle with the nerve to be stimulated within an arc of the curvature.

Devices, kits, systems, and methods for forward adjustment of a mandible of an individual for prevention, diagnosis, and treatment of sleep apnea, snoring, and other conditions, diseases, and disorders characterized at least in part by a rearwardly positioned mandible. A mandibular advancement device (MAD) includes an upper guard, a lower guard, and an adjustment piece that engages the upper guard and the lower guard to limit rearward movement of the lower guard relative to the upper guard during use. As the upper guard and the lower guard are worn by the individual, rearward movement of the mandible is also limited. A plurality of different adjustment pieces defines a plurality of different positions of the lower guard relative to the upper guard for gradual and correct titration of the mandible to gradually open and stabilize the oropharyngeal airway.

The present invention is in the field of medical technology and relates to devices for preventing or alleviating snoring and apnea problems insofar as they can be attributed to what is known as snoring at the base of the tongue. In order to provide that they are easier and more comfortable to use and more effective than, for example, classic protrusion splints, but also do not cause the risk of a gag reflex, a connection system between the tongue and teeth is proposed that causes a retentive grab on the surface of the tongue by means of a rough surface facing the tongue, in particular by many small tips, which is characterized in that it contains a slide-on element for sliding onto several teeth on the left and right side of the upper jaw or the lower jaw, and comprises at least a respective one hook in its right- and left-sided molar areas or in its canine tooth areas, each for generating a form-fitting connection between the slide-on element and an undercut location on the respective row of teeth, with one such device being used in the upper jaw and one in the lower jaw, and permanent magnets located on the outside in housings (70) attract each other and hold the tongue firmly in place. Ridges (100) arranged equidistantly on the housings (70) allow a freely selectable, comfortable protrusion of the lower jaw.

The present disclosure relates to heat mouldable mouth guards, to methods for using the mouth guards, and to methods for producing the mouth guards. In certain embodiments, the present disclosure provides a heat mouldable mouth guard, the mouth guard comprising: an inner framework comprising a semi-rigid thermoplastic; and an outer layer comprising an elastomeric thermoplastic which has a melting temperature higher than the semi-rigid thermoplastic of the inner framework, wherein the outer layer substantially encapsulates the inner framework.

A method of treating a patient, comprising: sensing a biological parameter indicative of respiration; analyzing the biological parameter to identify a respiratory cycle; identifying an inspiratory phase of the respiratory cycle; and delivering stimulation to a hypoglossal nerve of the patient, wherein stimulation is delivered if a duration of the inspiratory phase of the respiratory cycle is greater than a predetermined portion of a duration of the entire respiratory cycle.

An oral device for treating obstructive sleep apnea is generally described. In an embodiment, the oral device includes an anchoring member, a lip sealing member and an air transmission member configured to receive and transmit air to a user. The air transmission member may divide and distribute the air to multiple locations within the user's oral cavity. The anchoring member is configured to receive a dentition of the user. According to some embodiments, the lip sealing member may include an inner lip seal and an outer lip seal. The inner and outer lip seals are customized to the user's lips and may be slidably received on the air transmission member. Thus, the lip sealing member is configured to provide a substantially airtight seal for the user's lips, thereby limiting and/or inhibiting air exchange between the user's lips.

The present invention relates to a system and method of manufacturing a mouth piece by 3D printing a 3D printer readable file encoding the mouth piece, the method comprising steps of: obtaining a scan file comprising physical data representing a user's teeth and gum line using 3D scanner means (100); removing outlier data from physical data in the scan file; generating representative geometrical data of the curvature of the user's teeth and gum line from the physical data; generating a virtual base model representing a mouth piece from the physical data and the representative geometrical data, the virtual base model having customisable dimensions (101); removing selected regions from the mouth piece represented by the virtual base model (102); and from the virtual base model, generating the 3D printer readable file encoding the mouth piece for printing on 3D printing means (103). The present invention provides a computer implemented development environment adapted with user interface means providing an operator with the ability to customise the mouth piece as required.