Abstract: A device according to some embodiments may include a housing configured for location external to a body of a subject. The device may also include at least one processor associated with the housing and configured to communicate with a circuit implanted in the subject within proximity to a tongue of the subject, wherein the circuit is in electrical communication with at least one electrode, receive a physiological signal from the subject via the circuit, and send a control signal to the implanted circuit in response to the physiological signal, wherein the control signal is predetermined to activate neuromuscular tissue within the tongue.

Abstract: In an embodiment a device adapted to limit relative positioning of a mandible and a maxilla of a user includes a housing and a telescoping member movable within the housing to change a length of the device. An attachment structure extending from the housing pivotably connects the housing to one of the mandible and the maxilla. An attachment structure extending from the telescoping member pivotably connects the telescoping member to the other of the mandible and the maxilla. A stop adjustably positionable in the housing selectively limits movement of the telescoping member within the housing.

Abstract: A mouthpiece includes first and second bodies over teeth of a user. The bodies comprise frames with a bite pad between upper and lower teeth. The bite pad is molded in the frames while in situ in the mouth. The frames, prior to having the bite pads in place are hollow spaces with spanning elements spaced from each other projecting into the hollow space between a top and a bottom of each of the frames. An upper wall of the frame includes an inwardly directed lip directed towards a space inside the frames. A lower wall of the frame is extended in height relatively longer than the upper wall. A shim or a clip is inserted between the incisor edges for facilitating alignment of the incisor edges. The connector includes a slot for accommodating an extension of the shim when the shim is located with the connector.

Abstract: A device for prevention of snoring in the form of a neck collar with a middle section for placement under the chin of a user, side sections connecting to the middle section and end parts, optionally connectable to each other, consisting of a core of foam plastic contained in a covering. The foam plastic is a soft foam plastic, an opening is formed in the middle section and resilient means for adjustment of the height of the opening and thereby the height of the middle section are arranged in the opening.

Abstract: A mouthpiece includes first and second bodies over teeth of a user. The bodies comprise frames with a bite pad between upper and lower teeth. The bite pad is molded in the frames while in situ in the mouth. The frames, prior to having the bite pads in place are hollow spaces with spanning elements spaced from each other projecting into the hollow space between a top and a bottom of each of the frames. An upper wall of the frame includes an inwardly directed lip directed towards a space inside the frames. A lower wall of the frame is extended in height relatively longer than the upper wall. A shim or a clip is inserted between the incisor edges for facilitating alignment of the incisor edges. The connector includes a slot for accommodating an extension of the shim when the shim is located with the connector.

Abstract: A system, method and kit for treating obstructive sleep apnea. The system includes a first implant adapted for implantation in an inframandibular region and having at least one aperture therethrough, and a ribbon-like element having first and second ends and a substantially uniform, non-circular cross section along its length. The ribbon-like element is adapted for implantation in a tongue with the first and second ends extending through the at least one aperture in the first implant for coupling the ribbon-like element with the first implant.

Abstract: Snoring and obstructive sleep apnea are mitigated or controlled by restricting head movement during sleep. A headgear is disclosed with extensions at the rear of the headgear which impedes or blocks sleeping with the head in the supine position. Supine head position during sleep is a leading cause of snoring and obstructive sleep apnea. A sleep headgear is equipped with one or more extensions at the rear of the cap so that sleep in the supine position is uncomfortable. Straps are attached and extend from both sides of the headgear. The straps may be located in back of and/or in front of the ears and are fastened under the chin to hinder rotation, movement or removal of the headgear during sleep.

Abstract: According to one embodiment, a dental device is provided. The dental device includes an arch configured to engage at least some of the teeth of a user's dental arch and having a midline that aligns substantially with the anterior midline of the user's mouth when the arch is inserted in the user's mouth. The dental device further includes a dental attachment that includes an anchoring element configured to be outside the user's mouth when the arch is inserted in the user's mouth. The dental device further includes a second arch. The dental device further includes a flexible tension element including a substantially planar surface extending along the longitudinal axis of the flexible tension element, the flexible tension element configured to couple to the second arch proximate to the midline of the second arch and to couple to the anchoring element outside the user's mouth.

Abstract: An oral appliance includes a one-piece tray system that fits over the posterior teeth of the user and is custom-made or customized using lining material that conforms to the dentition of the wearer. The device may position the lower jaw in a slightly protruded position with respect to the upper jaw.

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: An intraoral airway having opposing trays with a soft lining or cushion to grip the maxillary and mandibular dental arches of a patient with a fixed relationship in such a manner as to gently open the mouth and thrust the mandibular component slightly forward thereby opening the oral cavity and hypopharynx for air/gas passage that is easily tolerated by fully awake patients/users as well as by sedated, anesthetized or obtunded patients.

Abstract: Systems and methods for controlling the position of a user of a wearable positional therapy device are provided. The wearable position therapy device can be configured to monitor and store physiological signals that can be used to assess sleep quality and sleeping position of a user. The device can be configured to be worn around the head, the neck, or body of the user. The device can be configured to provide feedback to a user if the user is sleeping or is positioned in a target position to induce the user to change positions. The feedback can be provided by one or more haptic motors that can be configured to provide various levels of feedback and the level of feedback can be customized based on the user's reaction to the feedback.

Abstract: A system for treating obstructive sleep apnea includes an anchoring element having scar tissue located in an inframandibular region, and a tongue implant having at least one arm extending therefrom, whereby the tongue implant is implantable in a tongue with the at least one arm being connectable with the anchoring element for coupling the tongue implant with the anchoring element. In one embodiment, the anchoring element includes a first implant part such as a flexible layer implantable in the inframandibular region and the scar tissue is formed on, in, and/or around the first implant part. The tongue implant is coupled with the anchoring element and/or the scar tissue through the at least one arm. The length of the at least one arm may be adjusted for shifting the tongue anteriorly.

Abstract: A system for revisably treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, first and second openings extend through first and second implant ends, respectively, for permitting a tissue plug to grow through each opening. Methods of using and revising such systems are also provided.

Abstract: This invention provides devices and systems and methods therefrom for properly controlling negative pressure applied to oral cavity, facilitating breathing and treating sleep apnea and snoring. The systems comprise a negative pressure system providing a vacuum source and an oral device comprising a shield, a tube passing through the shield, a flexible negative pressure deliverable part connected to the shield or the tube, an optional tongue protector, where the negative pressure deliverable part is conformable to the contour of the upper palate. Negative pressure is delivered to the front and back zones inside the oral cavity via the negative pressure deliverable part to eliminate air space in the oral cavity.

Abstract: An integrated oral appliance for treating breathing obstruction, snoring and restriction of the upper airway during sleep with a tongue restraint. Oral appliances of the invention may include an oral cavity engagement device including one or more trays, a tongue restraint with a tongue contact portion, a spring force element operatively coupled between the at least one tray and the tongue restraint, wherein the spring force element is adjustable anteriorly and posteriorly relative to the tray(s), and an air conduit inside the tongue restraint with a front opening of the air conduit extending beyond an anterior end of the tray(s) and a rear opening of the air conduit at a posterior end of the of the oral cavity engagement device configured to extend to a posterior surface of a tongue.

Abstract: A method for treating obstructive sleep apnea includes providing MAD therapy via an adjustable mandibular advancement device structured to advance the position of the patient's lower jaw, providing CPAP therapy via a mask system structured to deliver a supply of pressurized air to a patient, and selectively adjusting the mask system and/or the mandibular advancement device to alternate and/or balance between CPAP therapy and MAD therapy.

Abstract: A dental appliance is provided. The dental appliance includes a dental form configured to receive a portion of a dental arch of an individual, and an adhesive strip comprising a first side and a second side. The first side of the adhesive strip is attached to a portion of the dental form. The second side of the adhesive strip comprises a mucoadhesive configured to adhere the adhesive strip to a tongue of the individual such that the tongue of the individual can be selectively attached to the dental appliance.

Abstract: A wireless sleep apnea treatment system comprises a garment having at least one ECG monitor, a wireless signal acquisition board in communication with the ECG monitor and the computer and providing the electrical reading from the ECG monitor to the computer, and a patient stimulator controlled by the computer through the wireless signal acquisition board.

Abstract: An embodiment of a device in accordance with the present invention is adapted to be positioned at least partially in a mouth of a user to reduce resistance of air flow in the oral pharyngeal region and to improve anatomic and functional relationships of the oral pharyngeal structure. The device comprises a base unit adapted to be removably mounted on a lower jaw of the mouth, a pair of tongue positioner guides, each tongue positioner guide connected at a proximal end to the base unit, and a pair of tongue positioners, each connected with a distal end of a corresponding tongue positioner guide. The tongue positioner guides each comprise a bendable material so that the pair of tongue positioners are repositionable relative to the base unit.

Abstract: Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient's mandible, a tissue ingrowth implant configured to be implanted in a patient's tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient's mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient's mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

Abstract: Devices, systems and methods develop static and/or kinetic and/or pressure forces to fixate or brace tissue in targeted pharyngeal structures and individual anatomic components within the pharyngeal conduit.

Abstract: The invention relates to devices and methods for reforming tissue surrounding the airway of a subject suffering from obstructive sleep apnea so as to open the airway and alleviate the occurrence of apneic events. Devices comprise a combination of resiliently deformable material and bioerodible material. The deformable portion of the device has a preferred shape that corresponds to the desired final shape of the device once placed in an airway. In making a transplant-ready device, however, the deformable portion is placed into a deformed shape and constrained in that shape by the bioerodible material. After implantation, the device gradually assumes the preferred shape as the constraining bioerodible material erodes. As the device gradually reforms toward the preferred shape, it reforms the tissue into the therapeutically desirable configuration. The gradual nature of the shape change generally stabilizes the device in the tissue, and supports tissue reforming into a stable configuration.

Abstract: According to one aspect of the present invention, there is provided a device for treating sleep disordered breathing comprising a device body designed for positioning within a pharyngeal lumen and being designed and configured for maintaining an open airway during involuntary closure of the pharyngeal lumen. According to further features in preferred embodiments of the invention described below, the involuntary closure of the pharyngeal lumen is caused by collapse of airway tissue during sleep.

Abstract: An oral device is disclosed. The oral device comprises a mouthpiece member, a tube member and an attachment member. The mouthpiece member comprises a resilient material, and is adapted to fit within the contours of the teeth of a wearer. The tube member is affixed, at a first end, to the mouthpiece member, and extends outward from the mouthpiece member towards the soft palate of the mouth of the wearer. The attachment member is attached to the mouthpiece member at at least one location. Finally, the tube member defines an opening, which prevents the collapse of the soft palate of the wearer by allowing for the free transfer of air between the wearer and the environment.

Abstract: A system for treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, the implant body includes an adjustment element configured to allow in-situ adjustment of the implant body between first and second tensioning forces applied to the site. Methods of using such systems are also provided.

Abstract: A device for prevention of snoring in the form of a neck collar (1) with a middle section (2) for placement under the chin of a user, side sections (3, 4) connecting to said middle section and end parts (5, 6), optionally connectable to each other, consisting of a core of foam plastic contained in a covering. The foam plastic is a soft foam plastic, an opening (7) is formed in said middle section (2) and resilient means (14; 15; 27; 28) for adjustment of the height of the opening (7) and thereby the height of the middle section (2) are arranged in said opening (7).

Abstract: Apparatus for providing breathing assistance, the apparatus including a body including a recess for receiving teeth of a user to thereby position the body within an oral cavity of the user, a first opening extending beyond lips of a user to allow air from outside the oral cavity to be drawn in through the opening, a second opening provided in the oral cavity to allow air to be directed into a posterior region of the oral cavity and a channel connecting the first and second openings, the channel extending through at least part of a buccal sulcus of the user.

Abstract: The present technology provides a mandibular repositioning device (MRD) which may be self titratable. The MRD may be repositioned relative to the maxilla, e.g., the mandible may be brought, via the device, to a position forward of a neutral resting and/or bite position. The MRD allows for adjusting the maintained forward position by simply biting-down to preserve the desired degree of mandibular advancement. The present technology also allows for movement of the mandible in a lateral direction. The lateral movement is allowed for any forward longitudinal positioning of the mandible. The MRD may use a plurality of components that are coupled together and allow for lateral and longitudinal motion between each other. The present technology may be used in MRDs which may be self-fitted, typically by immersing the device in hot water and then biting into the device, making an impression of the teeth in the softened thermoplastic polymer.

Abstract: A mandibular advancement appliance is described which is secured to a subject's dentition. The appliance may adjust a position of the subject's lower dentition relative to the upper dentition while maintaining a distance between the upper and lower dentition. The appliance may also allow for the free rotation of the lower dentition relative to the upper dentition for increased comfort. Additionally, the appliance may also be utilized with a tongue retention assembly for maintaining a position of the subject's tongue relative to the device for treating sleep disordered breathing.

Abstract: A method of maintaining airway patency in an airway of a patient. The method includes the steps of implanting a device into airway-forming tissue without affixing the device to the tissue and permitting a bioerodable portion of the device to bioerode to apply a force to the airway-forming tissue to maintain airway patency. The invention also provides devices for practicing the method.

Abstract: At least one implant structure is sized and configured for implantation in, on, or near an extrinsic muscle region affecting movement and/or shape of a tongue, e.g., a genioglossus muscle. The position of the implant structure is stabilized relative to the extrinsic muscle region to maintain the tongue in a desired orientation, e.g., to maintain patency of an airway.

Abstract: An oral device for improving airway patency comprises a tongue constraint and a negative pressure source. The tongue constraint engages the patient's tongue to maintain a clear region below the palate in an oral cavity. By applying a negative pressure in the clear region, an airway behind the soft palate or tongue of the patient can be maintained. The tongue constraint is usually connected to an anchor. The anchor may be held between the patient's teeth or may engage the inferior surface of the palate. Another oral device for improving airway patency comprises a lateral tongue structure and a negative pressure source.

Abstract: A method, system and device for addressing the reduction of snoring includes a removable or dissolvable strip of material that adhere to mucosal tissue of a person's soft palate to provide stiffening support therefore, thus reducing the occurrence of vibration of such tissue during sleep. Preferred embodiments include of a specially textured surface, either one both or at least the outer side of an adhesive strip (the side facing away from the mucosal tissue to which it is attached) that has anti-microbial characteristics, bioluminescent expressions, etc. and a surface topography that resists bioadhesion of undesired bacteria that are typically present in a human's mouth.

Abstract: A method for treating obstructive sleep apnea, the method comprising: providing a tethering device comprising: an elastic filament having a distal end and a proximal end; and a flexible memory head mounted to the distal end of the elastic filament; advancing the tethering device through the tongue of a patient so that the flexible memory head of the tethering device is disposed against the back of the tongue and the elastic filament of the tethering device extends through the tongue; and securing the proximal end of the elastic filament to the mandible of the patient under tension, whereby to restrain rearward movement of the tongue while the patient is sleeping.

Abstract: Apparatus, systems, and methods constrain and/or support tissue structures along an airway.

Abstract: A TemporoMandibular Joint (TMJ) balancing appliance and a method for using the same are provided, in which a first base portion accommodates incisor teeth, a second base portion is extended from a left side of the first base portion and accommodates left molar teeth, and a third base portion is extended from a right side of the first base portion and accommodates right molar teeth. The first base portion includes an upper part for accommodating upper incisor teeth and a lower part for accommodating lower incisor teeth and has a center for accommodating the upper and lower incisor teeth higher than the left and right sides.

Abstract: The invention is a device for removable placement in the mouth, which advances the lower jaw and draws the tongue forward and upward, thereby providing relief for snoring and obstructive sleep apnea. The device includes an upper portion, the upper surface of which is adapted for engagement with the user's upper dentition. A downward extension, suspended from the anterior part of the upper portion, features an anterior surface that engages the back of the lower front teeth, so as to advance the lower jaw forward with respect to the upper jaw. The posterior surface of the downward extension features a rearward extension, which is curved upward at its lateral margins to meet the upper portion, so as to define, with the hard palate of the user, a cavity that is sized and shaped to snugly engage the user's tongue. Within the defined cavity, the device preferably features a soft elastomeric surface.

Abstract: Systems and methods are provided for optimizing the treatment of obstructive sleep apnea (OSA) using an oral appliance. The oral appliance can be configured by non-dental staff to safely conform to the dentition of a patient. The appliance includes configurable trays that include retention material that conforms to the dentition of the patient. The position of the upper and lower trays relative to one another can be adjusted both horizontally and vertically. The position of the upper and lower trays can be locked into place to maintain the position of the trays at a preferred treatment position. Methods for creating an appliance customized for a patient are also provided. Methods for using the customized appliance in combination with sleep study data is also provide. Methods for using the customized appliance to with pre-operative assessments and sleep study data to predict and reduce the risk of perioperative complications are also provided.

Abstract: The oral appliance for the treatment of sleep apnea provides greater comfort to the user and maintains an open air passage through the mouth by preventing the tongue from blocking the windpipe during sleep. The appliance has a mouthpiece including a frame of hard material and a tooth tray of softer material that conforms closely to the tooth pattern of the user. A spoon-like tongue depressor extends adjustably from the forward center of the device, the tongue depressor having a downward convex bowl that holds the tongue away from the windpipe of the user. The tongue depressor has a stein captured by and rotating in the adjuster, so that the tongue depressor may be prevented from rotating as the adjuster is threaded inwardly or outwardly in the front of the device. An air passage is preferably provided to each side of the tongue depressor adjuster.

Abstract: An auxiliary airway for treating obstructive sleep apnea is formed by implanting an elongated conduit beneath a pharyngeal wall of a pharynx. The elongated conduit has a proximal end in communication with a first region of the pharynx, a distal end in communication with a second region of the pharynx, and a section extending beneath the pharyngeal wall for bypassing an oropharynx region of the pharynx. The system includes a first opening in the pharyngeal wall in communication with a first opening in the elongated conduit, and a second opening in the pharyngeal wall in communication with a second opening in the elongated conduit. The system has a first anastomotic connector for coupling the first opening in the pharyngeal wall with the first opening in the conduit, and a second anastomotic connector for coupling the second opening in the pharyngeal wall with the second opening in the conduit.

Abstract: The invention relates to a functional dentofacial orthopedic apparatus (1) made of a flexible material and comprising two grooves, the general outer shape of each of which is a flared U when viewed horizontally, the two grooves being separated by a substantially horizontal partition (6). Each groove defines an alveolar canal (4, 5) encompassing the superior and inferior alveolodental arches, respectively, said canal (4, 5) consisting of a labial bar (2) and a lingual plate (3), as well as the horizontal partition (6), the inner surface of each canal being smooth. According to the invention, the apparatus includes: a continuous angled lingual ramp (10) which is intended for supporting and guiding the tongue toward the palate and the upper portion of which consists of a reinforced inner raised portion (9), the general shape of which is flared U and which extends over the inner circumference of the grooves.

Abstract: A sleep apnea device having top and bottom trays, as well as a method of use thereof, is disclosed herein. Each tray is adapted to be retained on respective top and bottom teeth, the bottom tray having two flanges extending upwards from a generally planar side of the bottom tray, opposite a side which abuts the teeth. As such, when worn, the flanges extend toward the top tray. The top tray has corresponding flat regions on each side thereof which cut into the outside (relative to the teeth) plane of the tray. The flanges thus abut such flat regions on the outer side of the upper tray, pushing the lower tray and, therefore, lower teeth and tongue forward. A wearer may then sleep wearing the trays, prevent obstruction of the airways by the tongue during sleep.

Abstract: A sleep apnea dental appliance and a method for constructing said appliance. The sleep apnea dental appliance and the method for constructing said dental appliance offers patients a mandibular advancement splint that is custom fitted to their upper and lower teeth. The apparatus reduces strain to the patient's mandible while in the advanced position. The sleep apnea dental appliance utilizes a maxillary dental arch and a mandibular dental arch fused together in a particular configuration determined by precise measurements taken by dental professional. The method of construction allows the apparatus to be constructed at relatively low cost which can translate into low costs for the patient.

Abstract: According to one embodiment, a dental device is provided. The dental device includes an arched frame configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch. The arched frame defines a plurality of apertures, and the arched frame includes an adjustment mechanism. The dental device further includes a moldable tray coupled to the arched frame. The moldable tray engages the plurality of apertures and includes a channel configured to engage at least some of the teeth of the user's dental arch.

Abstract: A method for automatically controlling negative pressure supplied in oral cavity, for relieving sleep apnea and snoring is provided. The method includes: sensing a physiological signal from the user and outputting the sensed physiological signal; extracting a physiological status based on said sensed physiological signal; and automatically controlling said negative pressure provided to the user's oral cavity based on said physiological status.

Abstract: An oral device for improving airway patency includes a base adapted to be held between a patient's upper and lower teeth and a tongue-engaging member. The tongue-engaging member engages the tongue and displaces the tongue anteriorly when the base is held between the patient's teeth. A vacuum is applied through the base and the tongue-engaging member in order to draw the soft palate against a posterior region of the tongue in order to stabilize the soft palate and open or clear the patient's airway.

Abstract: A foam positioner device utilized for maintaining resting limb positioning, hand shape and strength therapies, and other modality therapies. Said device, by means of an integrated strap slot base, incorporates a generic strap which wraps around furnishings such as pillows, recliner footrests, beds, chairs, and various medical apparatus exclusively and does not attach to the person.

Abstract: TENS can be applied to the TMJ of an athlete for a period of time to deprogram muscles. After TENS, a desired position of the lower jaw relative to the upper jaw can be determined and recorded. The desired position can be a physiological resting position, or a performance position in which the lower jaw is positioned anteriorly relative to the physiological resting position. A mouthpiece can be prepared including bite portions configured to substantially space apart and position the jaws according to the desired position, and substantially prevent movement of the lower jaw relative to the upper jaw. A connecting portion connects the bite portions within the mouth, and may extend labially along the anterior teeth and associated gum region of the lower jaw, and may be sized and shaped to substantially lie out of the way so as to not impede speech of the athlete.

Abstract: Systems for sizing oral appliances comprise both a width measuring template or tool for determining the distance between opposed molars and an arch sizing tool for determining the size and shape of the patient's dental arch. Based on this information, individual appliances can be selected from an inventory of such appliances, where the selected appliance would best fit the patient.