Abstract: A treatment for obstructive sleep apnea (“OSA”) of a user includes affixing a patch externally on a dermis of the user, the patch including a flexible substrate, an adhesive on a first side adapted to adhere to the dermis of the user, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate. The treatment includes detecting an occurrence of OSA and activating the patch in response to the detecting, the activating including generating an electrical stimuli via the electrodes to activate the genioglossus muscle of the user.

Abstract: A device manufactured using CAD/CAM, including an upper splint (1) with followers (19) and various lower splints (2) including contact surfaces (3a) on which the followers (19) contact, so that on exchanging lower splints for others, according to a manufacturing sequence, they cause different controlled mandibular advancements. The contact surfaces (3a) reproduce a movement from the contact of the followers (19) on said contact surfaces (3a). The device is customised for each patient according to a set of anatomical parameters, and a series of input data measured by doctors, which personalise the device to achieve opening movement with single protrusive advancement in each of the lower splints (2).

Abstract: The present invention relates to head and neck pillows configured to provide proper support and advantageous positions of the head and neck for reducing spinal stress, maximizing air flow via the respiratory pathway and promoting healthy restorative sleep in a user. The head and neck pillow comprises an open head positioning support area, neck support areas when the user is resting in supine position. The invention further discloses a first side and a second side of the head and neck pillow comprising support areas for the side of the head and neck as well as curved transition surfaces for smooth transitioning of the head and neck of the user from supine or prone to side resting positions. In an embodiment, the invention discloses a head and neck pillow with an open head positioning area, a neck support area and a handle positioned adjacent to the open head positioning area.

Abstract: An apparatus and method to convert a dental, oral, orthodontic appliances, retainers, and dentures into a multifunctional oral appliance. The apparatus includes plurality of mechanical connectors and attachments made of plastic, ceramic, or metal, that convert any dental or oral appliances, into multipurpose, three dimensionally adjustable oral appliances for treating obstructive sleep apnea, snoring, temporomandibular joint and musculoskeletal disorders of the jaw, and for improving breathing from the mouth even when nasal passages are blocked.

Abstract: An adjustable dental appliance having an upper tray and a lower tray is provided. The upper tray includes an upper dentition-interfacing layer and an upper support layer. The upper support layer has indentation tracks oriented in a mediolateral direction when an arch shape of the upper tray is aligned with an upper dental arch. The lower tray includes a lower dentition-interfacing layer and a lower support layer. The lower support layer has rails attached to an upper surface thereof and oriented in a mediolateral direction when an arch shape of the lower tray is aligned with a lower dental arch. The rails of the lower tray fit securely into the indentation tracks of the upper tray and thereby interlock the upper tray and lower tray.

Abstract: Disclosed herein are mandibular advancement devices comprising an upper splint and a lower splint, where the upper splint comprises one or more upper fins, where each upper fin is located at a distance UD from back of the upper splint; the lower splints comprise one or more lower fins, where each lower fin is located at a distance LD from back of the lower splint; where the position of the upper and lower fins is unchangeable. Also disclosed are methods of reducing partial constriction of airway during sleep for a patient, the method comprising identifying a patient in need thereof; and administering to the patient the disclosed mandibular advancement device. Also disclosed are methods of manufacturing a mandibular advancement device, the method comprising obtaining measurements from a patient's dentition; digitally designing a mandibular advancement device; and milling the mandibular advancement device.

Abstract: The disclosed embodiments includes apparatuses, devices, and methods for treating a breathing disorder, comprising: inserting a first target oral stud into a first location of an anchor structure, the first target oral stud including a target stud shaft, a target anterior anchor, and a target posterior anchor, wherein the target stud shaft (or suture) is positioned within the tissue of the anchor structure. The embodiments further comprise inserting a first support oral stud into a first location of a support structure, the first support oral stud including a support stud shaft (or suture), a support anterior anchor, and a support posterior anchor, wherein the support stud shaft is positioned within tissue of the support structure. Further, the embodiments comprise connecting, using at least one first connector, the target anterior anchor with the support anterior anchor.

Abstract: Oral appliances, and systems and methods, which include oral appliances are described herein. An example oral appliance device for treatment of a sleep disorder or condition in a subject can include an upper portion configured to receive at least one maxillary tooth of the subject, and a lower portion configured to receive at least one mandibular tooth of the subject. The upper and lower portions are engageable such that the portions maintain a restricted orientation relative to each other when engaged, and the engaged restricted orientation is configured to maintain the mandible of the subject in a predetermined clinically beneficial orientation relative to the maxilla.

Abstract: An appliance and methods are described that include embodiments of a mandibular advancement or positioning device which can use elastic bands to pull the jaw forward. The appliance has an upper plastic tray conforming to the patient's upper teeth and including a set of retention hooks coupled to the upper plastic tray via being encased in plastic, one on the right and one on the left anterior buccal portion of an upper plastic base. The appliance also has a lower plastic tray conforming to the patient's lower teeth and has a set of bite pads integrated with a second set of plastic retention hooks encased in plastic extending outwardly from the teeth. The appliance includes the upper and lower plastic trays and specially formed elastic bands of a plurality of lengths and strengths replaceably attached to the retention hooks on both sides of the trays to pull the mandible forward for treatment.

Abstract: Systems and methods are provided for treating snoring or sleep apnea of a patient that include an implantable device and a retainer. The device includes an elongate filament sized for introduction into or through a patient's tongue and including a distal end and a proximal end, a connection member on the proximal end, and one or more securing elements on or adjacent the distal end. The retainer includes a body configured to be removably engaged with one or more teeth within a patient's mouth, and a connector port for removably engaging the connection member to support the patient's tongue relative to the retainer.

Abstract: A mouth guard that can be used with elastic band in place on braces provided. In one example, a mouth guard for protecting teeth during athletic activities is provided that includes a generally u-shaped base coupled to inner and outer flanges to form a teeth receiving pocket. A first slot is formed through a left side the outer flange and open though a top of the outer flange. A second slot is formed through a right side the outer flange and open though a top of the outer flange.

Abstract: A system and method for treating sleep apnea includes inserting an implantable pulse generator subcutaneously within a body of a patient and connecting a lead to the pulse generator. The lead is inserted within the vasculature and advanced transvenously through the vasculature until a stimulation portion of the lead becomes positioned in close proximity to the hypoglossal nerve. A nerve-stimulation signal is applied to the hypoglossal nerve via the stimulation portion of the lead.

Abstract: An oral appliance including an upper body having an upper body channel to receive a maxillary dentition of an upper dental arch, a lower body having a lower body channel to receive a mandibular dentition, and at least one node disposed on the lower body base outer surface to engage the upper body outer surface upon receipt of the maxillary teeth of the upper dental arch in the upper body channel and the mandibular teeth of the lower dental arch in the lower body channel.

Abstract: A device (10) having a body (12) formed from as a one-piece single unit having a first tray portion (16) for receiving the upper dental arch of the oral cavity of the wearer and a second tray portion (14) for receiving the lower dental arch of the oral cavity of the wearer. Integrally formed therewith and connecting the two tray portions are two connecting portions (18), (20) which are flexible and the two tray sections are of a design or material or combination of design and material selected to achieve retention of the trays on the teeth of a user.

Abstract: Suture passer systems for tissue suspension and tissue compression are described. The system can include a shaft and a needle, wherein the needle is freely rotatable with respect to the shaft. The suture may include an overmolded segment. Methods of placing one or more implants, sutures, fastener, bone anchors and other devices are also described. The methods include moving tissue, including the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The methods include hyoid bone suspension.

Abstract: The present invention is a two part device to prevent a person from snoring consisting of a mouth guard with an attached tongue suppressor. The tongue suppressor attaches to the mouth guard in a manner so that it is adjustable in length and creates a downward pressure on the base of the tongue. The underside of the tongue suppressor has ridges that angle forward to engage papillae on the tongue and thereby prevent the tongue from moving rearward in the mouth during sleep.

Abstract: A portable, battery powered apparatus (10) generates an electrical signal between electrodes (15a, 15b) to be applied to the skin of a patient for reduction or prevention of snoring or obstructive sleep apnoea. The signal comprises electrical stimulation at a frequency of 1-100 Hz and the signal comprises a stimulation free period of at least 0.5 seconds every 20 seconds, avoiding muscle fatigue when used for long periods, e.g. overnight.

Abstract: An oral appliance comprises interacting upper and lower dental encasing components formable to overlay portion of the patient's upper and lower teeth. The dental encasings each comprise sheets of a heat softenable and moldable over-mold material on substrates comprising one or more pieces of a stiffening material. The over-mold material is heated to a moderately elevated temperature which will not cause tissue damage when placed in the patient's mouth. While still warm the material can be shaped to conform the patient's teeth but is non-deformable once cooled to body temperature. The stiffening material is non-deformable when heated to the same elevated temperature.

Abstract: 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 be provided with pharmaceutical compound reservoirs that deliver pharmaceutical compounds to the oral mucosa of the user, which compounds treat symptoms of sleep apnea. 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 and/or pharmaceutical compound reservoirs.

Abstract: An implanted tongue pulling device including a pull plate, a pull line, a retractor and a method thereof are provided. The tongue pulling device is implanted in the mandible and tongue of a human body, respectively, for tightening the tongue dorsum and/or the tongue base for treating obstructive sleep apnea/hypopnea syndrome (OSAHS). At least three pull lines are used for positioning the pull plate, which is a flat object implanted beneath the tongue dorsum and/or the mucous membrane of the tongue base and includes through holes for the growth of tissues and pull line fixing mechanisms. The pull line includes a draw line and a sleeve. The retractor includes a casing, a control switch and a pull line fixing device mounted on the casing. A patient after surgery can adjust the tightening extent of the implanted tongue pulling device by pressing the skin outside the control switch, thereby preventing OSAHS.

Abstract: A nasal valve implant delivery system includes a delivery tool having a handle and a needle extending distally therefrom and configured to hold an implant therein. When loaded in the needle, the implant proximally abuts or is disposed adjacent to a pusher member disposed partially within the needle. A light source disposed within the delivery tool is coupled to an optical fiber carried within a lumen of the pusher member. The delivery tool includes a moveable needle shuttle disposed in the handle that is coupled to the needle. An actuator disposed in the handle is configured to releaseably engage with the moveable needle shuttle, wherein the needle shuttle is coupled to one or more springs configured to apply a proximal tensioning force on the needle shuttle, wherein actuation of the actuator retracts the needle proximally into the handle and releases the implant.

Abstract: Suture passer systems for tissue suspension and tissue compression, and more particularly for tongue suspension, are described. The system can include at least a first elongate tubular body or shaft, a needle having a lateral bias carried by the elongate body, and a retrieval element operably connected to the elongate tubular body. The needle can have a substantially straight configuration when located within the elongate tubular body, and be configured to exit an opening at or near a distal end of the elongate tubular body and assume a laterally biased or curved shape to form a path through tissue. The needle is configured to carry a suture. The retrieval element can be configured to retrieve the suture carried by the needle after the needle has formed a curved or otherwise angled path through tissue. The system can also include one or more bone anchors to secure the suture loops. Methods of placing one or more suture loops into tissue, such as the base of the tongue, are also described.

Abstract: A method and apparatus for the amelioration of sleep apnea and other obstructive breathing disorders in a patient includes a collar configured to encircle the patient's neck, and a jaw-engagement mechanism carried by the collar. The jaw-engagement mechanism includes a pad configured to contact the underside of the patient's lower jaw in the area of the anterior triangle behind the mandibular symphysis and to be received in a small hollow of the patient's jaw. In use, the pad can apply force against a surface of the patient's lower jaw in order to push it forwardly and upwardly. The pad preferably is secured to a movable post that can be positioned such that a desired amount of force is applied to the patient's lower jaw.

Abstract: Systems, devices and methods are disclosed for concurrently treating temporomandibular joint dysfunction (TMD) and orthodontically moving teeth. The devices can have an orthodontic aligner and a TMD treatment device. The devices can be configured to concurrently reposition a mandible and orthodontically move one or more teeth.

Abstract: A device for treatment of sleep apnea or snoring of a user which has an upper oral splint adapted for an upper jaw of the user, and a lower oral splint adapted for a lower jaw of the user. At least one of the oral splints has adjustment devices on them, with a fixation device for adjustable and detachable fixation of an abutment element. Since the abutment elements are adjustable and detachable, a flexible device is provided where the setting can be adjusted and parts can be replaced when needed.

Abstract: Disclosed is a mandibular advancement device including a first frame, a second frame, a first rib on the first frame, the first rib extending generally from a front side of the first frame to a back side of the first frame, a first upstanding sidewall facing the first rib, a first channel on the second frame, the first channel in relative position to interface with the first rib, and an opening of the first channel, the opening of the first channel having a width that is narrower than a width of the first rib.

Abstract: Herein disclosed are methods of using nasal inserts for various different ailments. Easy modification of the insert allows for treatment of various ailments that can readily be treated via the nose, such as ailments triggered by smell. Specifically, the insert can direct air into or out of the nasal cavity and/or delivers medicinal substances to the appropriate regions, thereby providing the appropriate therapeutic effect, depending on the ailment being treated.

Abstract: A method of treating sleep disorder breathing in a patient, the method comprising in a first step providing a set of oral appliances comprising a first and at least a second oral appliance (30). Each of the first and at least second oral appliances comprises a generally U shaped appliance body including an inner wall (34), an outer wall (36), and a web (38) interconnecting the inner wall and the outer wall. The web has a front section and two arms with trailing ends. The web comprises at least one breathing hole (80) so as to define a total cross sectional area for breathing and the total cross sectional area for breathing of the first oral appliance is larger than the total cross sectional area for breathing of the second oral appliance. In a second step, a patient wears the first oral appliance in a first treatment stage whilst sleeping for a first period of time and in a third step the patient wears the second oral appliance in a second treatment stage whilst sleeping for a second period of time.

Abstract: A hands-free grooming device configured to align with a center point on a user's chin and secure to the user's face via tension created between the user's face when a plurality of tabs are secured to form head and neck straps. Once secured, the grooming device enables the user to perform grooming operations without holding the grooming device in place, resulting in a consistently shaped beard with defined edges.

Abstract: An oral device for preventing sleep apnea is provided. The oral device maintains an opening between the anterior teeth, resulting in a wider upper airway, while allowing the mouth to also open for yawning and normal talking. The oral device provides an upper plate and lower plate, each adapted to retain the biting surface of the respective set of maxilla and mandible teeth, wherein curved rods pivotally interconnecting both plates are adapted for maintaining an operable spaced apart relationship therebetween. The oral device is a unitary construction made from FDA-approved elastomers.

Abstract: Disclosed is a full movement jaw advancement oral appliance that is worn in the mouth of a user to reduce the effects of snoring and/or sleep apnea. The oral appliance includes an upper arch tray assembly against which the user's upper teeth carried are received, a lower arch tray assembly against which the user's lower teeth are received, and an intermediate guide post support tray that is connected at the bottom thereof to the lower arch tray assembly and at the top thereof to the upper arch tray assembly by an upper arch tray retaining post that extends therebetween. The upper arch tray assembly is movable in both horizontal and vertical directions relative to the lower arch tray assembly so that the positions of the user's upper and lower jaws can be adjusted relative to one another and the upper arch tray assembly will remain in receipt of the user's upper teeth when he opens his mouth during sleep.

Abstract: An oral device (2) is designed to be worn in the mouth by a person and to stress the trigeminal nerve during swallowing. A method of learning the performance of an action, which includes the wearing of an oral device (2) by a person in order to stress the trigeminal nerve during swallowing.

Abstract: A sleep apnea prevention sleep-aid mask is described. The sleep-aid mask is configured to secure the lips of a user together in a natural state, in order to encourage the respiratory system of the user to employ the nasal passages rather than the mouth for respiration. A pad equipped with a perforated mesh or channel is positioned over the lips and mouth of the user, and secured in position on the user via an adhesive, which temporarily affixes the pad to the face of the user. The sleep-aid mask is preferably shaped and sized according to the specific size of the user's face, and is configured to limit the effective diameter of the mouth of the user, in order to cause continued use of respiration via the nasal passages.

Abstract: A tongue manipulation device (10) has a tissue anchor (20) for attachment to the tongue, a bone anchor (22) typically for attachment to the mandible and a tether line (24) which fixes the tissue anchor to the bone anchor. The bone anchor comprises a tether line spool arrangement which comprises a spool (46) rotatable about a spooling axis and a spooling locking arrangement (54). The spooling locking arrangement is controlled by rotation about the spooling axis between spooling locking and permitting configurations. In this way, the physician implanting and setting the device can perform titration and subsequent locking as two independent operations.

Abstract: A mandible support device comprising a structural member comprising a support component and an adhesive component. The support component is configured to extend from the head or face above the mandible to the region of the gonial angle. The adhesive component is configured such that the structural member can be temporarily attached to the skin.

Abstract: A method or apparatus comprising monitoring a user's sleep, and turning on a microphone to record sounds, ensuring that the recording occurs in all sleep phases. The method in one embodiment further comprising making the sounds available to the user for later review.

Abstract: An oral device for temporary placement in a patient's oral cavity includes upper and lower jaw braces and a tongue-engaging member. The upper and lower jaw braces are connected so that the lower jaw brace is advanced in an anterior direction relative to the upper jaw brace when the upper and lower jaw braces are closed together. A partial vacuum is drawn in the oral cavity and the vacuum and lower jaw displacement together control the position of the tongue in order to clear the patient's airway to reduce sleep apnea or treat other conditions.

Abstract: An anti-snoring mouth guard for insertion into a mouth of a user for decreasing snoring and the effects of sleep apnea includes a mouthpiece portion having a bottom wall and a pair of upstanding side walls displaced and opposite one another and extending upwardly from the bottom wall, said mouthpiece having a hemispherical configuration that is complementary to a shape of the user's teeth. Collectively, the bottom wall and pair of side walls define a channel operable to receive teeth of a user's upper pallet. The anti-snoring mouth guard includes tongue depressor portion having a proximal end coupled to the mouthpiece and having a body extending rearwardly at a generally downward angle. A brace may extend between rear ends of the mouthpiece portion and define levels by which the tongue depressor may be inserted such that the tongue depressor may be adjusted vertically and front-to-back.

Abstract: Embodiments of methods and mandibular protruders and positioning devices, comprising, for example: an upper mounting bracket having an upper dental appliance; a lower mounting bracket having a lower dental appliance; and a rail system configured to couple the upper mounting bracket to the lower mounting bracket. Some embodiments comprise a drive motor and/or an initial position adjustment mechanism.

Abstract: A device and a method for creating and/or maintaining an obstruction free upper respiratory passages. The device is configured to fit under the chin of a subject adjacent to the subject's neck at an external location corresponding approximately with the subject's internal soft tissue associated with the neck's anterior triangle. The device is capable of exerting negative pressure on the surface of a subject's neck, displacing the soft tissue forward and enlarging the airway.

Abstract: Disclosed herein are splints for a mandibular advancement device, each splint comprising one or more guided fins, wherein each guided fin is located at a distance D from back of the splint; a back post; at least one threaded rod connecting the back post to the guided fin, wherein the distance between the guided fin and the back post is changed when the threaded rod is turned either clockwise or counterclockwise; and a guiding mechanism.

Abstract: Improved systems, methods, and devices for treating sleep apnea are provided herein. In one aspect, an intraoral appliance for treating sleep apnea in a patient comprises an appliance shell comprising a plurality of cavities shaped to receive teeth of a jaw of the patient. The appliance shell can comprise an advancement structure arranged to interact with an opposing jaw of the patient so as to displace the lower jaw anteriorly relative to the upper jaw. The plurality of cavities can comprise cavity geometries shaped to reduce repositioning of one or more received teeth elicited by displacement of the lower jaw anteriorly relative to the upper jaw.

Abstract: A computationally implemented method includes, but is not limited to: determining an incrementally progressive series of adjustment appliances, each of the series of adjustment appliances having geometries selected to progressively reposition teeth; and determining for each of the series of adjustment appliances, a vertical displacement and a forward mandibular position for treating sleep apnea. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the present disclosure.

Abstract: A method of forming oral orthotic systems includes providing an upper dental member adapted to be placed in connection with upper dentition of the patient, providing a lower dental member adapted to be placed in connection with lower dentition of the patient and providing a plurality of posterior mounting structures. Each of the posterior mounting structure is configured to be attached to one of the upper dental member or the lower dental member at a posterior, buccal position thereon. Force may be applied to the mandible of the patient via at least one of a plurality of different types mechanisms via attachment of a component of a selected type mechanism to at least one of the posterior mounting structures.

Abstract: Sleep monitoring and stimulation comprises collecting actigraphy data from a user. The user's sleep phase is determined using the actigraphy data. At least one stimulation, determined at least in part on the sleep phase, is directed towards the user. Subsequent actigraphy data is collected from the user. The actigraphy data and subsequent actigraphy data is used to determine the user's subsequent sleep phase. The stimulation is modified, based at least in part upon the subsequent sleep phase.

Abstract: The present invention provides a bed set for inhibition of obstructive sleep apnea, which includes: a sound receiving module, is used to receive a respiratory sound signal obtained from a user during a time period; a sound analyzing processor, which is connected with the sound receiving module, is used to obtain a snoring sound characteristic from the spectrum of respiratory sound signal; a database, which has a plurality of snoring image characteristics corresponding to a plurality of basic snoring sound characteristics for different respiratory actions; a control processor, which is connected with the sound analyzing processor and the database, is used to compare the snoring sound characteristic with the basic snoring sound characteristics to select one of the snoring image characteristics in the same waveform, and provides the first angle control order and the second angle control order corresponding to the selecting snoring image characteristic; a first pillow, which is connected to the control processor,

Abstract: 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.

Abstract: A medical appliance for the treatment of one or more sleep disorders such as obstructive sleep apnea in a patient, the appliance comprising: a biasing member for inserting behind and exerting a force upon the patient's soft palate or tongue, wherein the biasing member is inserted in a reduced or minimized form and then expanded or firms once in place to exert the force. The appliance may be nasally inserted or be placed through the mouth. In a particular configuration, both the soft palate and tongue are biased to prevent obstruction of the flow of air in the nasopharyngeal airway.

Abstract: Apparatuses and methods for improving airway patency are provided. A medial surface of the patient's tongue is constrained with a tongue constraint of an oral device placed in the oral cavity to generate a clear region between the medial surface and the hard palate. The clear region is in fluid communication with the soft palate. The tongue constraint has superior surface and inferior surfaces configured to generate the clear region. Negative pressure is applied within the oral cavity to hold the soft palate in a position in which the airway is at least partially open. The negative pressure is applied through one or more ports of the oral device. The one or more ports remain unobstructed by the tongue when the negative pressure is applied. The applied negative pressure causes the soft palate and tongue form a seal whereby the patient's airway is substantially fluidly isolated from the clear region.

Abstract: A retainer with a block extending downwards from an otherwise generally flat surface is disclosed. The block corresponds to a region of one or more of the cuspids or pre-molars. A side block or other device on the upper retainer also abuts a wing or other abutment device of a lower retainer, causing the lower jaw to be pushed forward relative to the upper jaw and resting position (regular organic closing position) of the upper and lower jaw together. Thus, the upper teeth are pushed forward and a space is created between the teeth behind the (lower) block preventing an apnea during sleep.