Abstract: An intra-oral dental appliance for treatment of sleep disorders including snoring, sleep apnea and nocturnal bruxism. The appliance includes an upper member conforming to the patient's maxillary dentition; a lower member conforming to the patient's mandibular dentition; and a connecting assembly for adjustably coupling the upper and lower members together. The connecting assembly includes a first element mounted on the upper member, the first element having a cavity therein; a second element mounted on the lower member; and a connector having a first end captured within the cavity and a second end adjustably connectable to the second element. The connecting assembly maintains the lower member in a protruded position relative to the upper member to maintain the patency of the user's pharnygeal airway while permitting anterior and lateral movement of the lower member relative to the upper member in the protruded position.

Abstract: An oral cavity manipulator for controlling the position of tongue and jaw, the manipulator including a foundation body, maxilla and mandibular teeth engaging elements mountable on the foundation body and having width equal to or greater than the width of the foundation body and including teeth receiving portions for in use receiving the teeth of the user, a tongue position means attached to one of the foundation body, or the teeth engaging elements wherein in an operating condition the mandibular teeth engaging element is selectively located on the foundation body forward of the maxilla teeth engaging element to receive and locate the mandible of a user forward of the maxilla and position the tongue between the teeth elements to substantially maintain unobstructed airways at the throat of the user.

Abstract: Provided herein are oral appliances and methods of using oral appliances for treatment of sleep disorders and conditions.

Abstract: A method and apparatus for securing a uvula to a soft palate. The uvula may be attached to either the nasopharyngeal side or the oral side of the soft palate with a uvula securement device. The uvula may be secured to the nasopharyngeal side of the soft palate with a suture.

Abstract: The device relates to methods and devices for the treatment of obstructive sleep apnea syndrome.

Abstract: A nasal breathing aid includes a base portion and two extending diverging arms. The arms, near their base include inward facing contact elements which are adapted to “pinch” the vomer bone within the nose. The arms, at their outer ends, include outward facing contact elements which are adapted to apply pressure to the inner wall of the nostrils, urging a wider passageway through the nostrils.

Abstract: A mouthpiece includes first and second bodies over teeth of a user and connector between the bodies. 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. The material of the bodies and connector employ a durometer selectively between Shore A 40-45, and selectively the amount of material is between 4-6 grams for each of a first base putty and for a second catalyst putty for the making of the guard, in combination with the frame. At least one putty is of a first color and selectively the second putty is a same or different color to the first color, and at least one frame is selectively clear or colored, and at least one of the putties includes a flavoring or is flavorless.

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: An insertion device and method of use for treating obstructive sleep apnea. The device includes an outer tubular element with a tissue penetrating end and a side opening, an inner tubular element positioned partially within the outer member and movable longitudinally relative to it, a grasping device fixedly coupled to the inner element, and a central shaft extending through the inner tubular element and movable longitudinally relative to the inner and outer tubular elements. The central shaft is slidably coupled with the grasping device. The inner tubular element is further movable between a retracted position wherein the grasping device is positioned entirely within the outer tubular element, and an extended position wherein it extends outwardly therefrom through the side opening. In the extended position, the grasping device is adapted to grasp a filamentary element positioned external of the outer tubular element and in proximity thereto.

Abstract: A system and method are disclosed for the securement of tissue and in particular for placement of a tongue base suspension fiber for the treatment of obstructive sleep apnea. The system incorporates disposable connectors with releasable needles to facilitate the placement of fibers with minimal increase in suture site dilation or trauma.

Abstract: The current invention relates to an adjustable mandibular advancement device with a unique combination of resilient hinging and adjustability to prevent or reduce snoring and/or obstructive sleep apnea syndrome. The adjustability is described by means of two concepts of adjustability for the relative enlargement or diminution of the members of the device, incremental and successive advancement mechanisms, in either combination or separately. By use of thermoplastic materials the device can be used in the outmost variability of the human dentition.

Abstract: A system and method for controlling a device to alleviate sleep apnea comprises determining whether a user of the device is asleep by a microcontroller operatively connected to the device. Using a sensor operatively connected to the microcontroller, it is determined whether a breathing anomaly of the user is detected while the user is asleep. An electromagnet operatively connected to the device generates an electromagnetic field to widen an airway of the user in response to detecting the breathing anomaly while the user is asleep.

Abstract: The current invention relates to an adjustable mandibular advancement device with a unique combination of resilient hinging, dentition engagement and adjustability, to prevent or reduce Snoring and/or Obstructive Sleep Apnea Syndrome. The adjustability is described by means of two concepts of adjustability for the relative enlargement or diminution of the members of the device, incremental and successive advancement mechanisms, in either combination or separately. By use of thermoplastic materials the device can be used in the outmost variability of the human dentition.

Abstract: An oral appliance assembly is described. The assembly includes an oral appliance component having an upper teeth tray and a lower teeth tray. The assembly further includes a module releasably connected to the oral appliance. The module includes at least one sensor that is positioned outside of the mouth and underneath the nares of a subject's nose when the oral appliance component is positioned in the subject's mouth. A method of measuring user compliance of an oral appliance is also described. The method includes positioning an oral appliance in the mouth of a subject, measuring at least one parameter of airflow from the subject's nose or mouth, and determining compliance based on the at least one measured parameter. A method of measuring effectiveness of an oral appliance is also described.

Abstract: Disclosed is a dental appliance composed of a thermo-plastic polymer with low compressibility, high toughness, and high tensile strength, with a low softening point. The appliance has perforations that enable it to be easily custom-fitted by the user or a health professional. The appliance begins as a generally U-shaped, unformed dental tray that is significantly thinner than existing dental appliances. Once fitted, the dental appliance provides superior protection against damage to the enamel of the teeth and abrasion of the teeth due to bruxism or other mechanism leading to biomechanical wear of dental surfaces. The perforations facilitate the custom-fitting process by allowing the user to suck air through the perforations, thus applying a negative pressure between the material and the teeth while the material is still soft and pliable.

Abstract: An oral treatment device for sleep apnoea and snoring, including a pad adapted to rest under the tongue of a user, so as to support the tongue from below, and engage the lower surface of the tongue using a reflex action of the relaxed tongue, the tongue flow adaptation effect. Implementations also include textured surfaces on the front of the device to encourage the tongue-tongue reflex and tongue protrusion. The device is designed to be tolerated for relatively long periods of time, and minimise any disruption to sleep, while providing effective tongue positioning.

Abstract: The cheek path airway fits a path between a user's lips and through the user's cheek pouch and rear-jaw gap, avoiding the user's bite. It provides supplemental air to a user's rear-mouth cavity independently of a user's nasal airways while a user's lips remain closed. The airway can be used in combination with mandibular jaw-control and tongue-control devices whereby the combination mitigates breathing restrictions in a user's nasal and throat airways. The cheek path airway can be combined with and stabilized by a cheek pocket anchor, formed of a resilient filament, that fits within a user's cheek pouch.

Abstract: A breathable gas supply apparatus for a patient features a breathable gas supply system and a respiratory mask assembly in communication with the breathable gas supply system. The breathable gas supply system provides a supply of breathable gas to the respiratory mask assembly and removes a supply of exhaled gas from the respiratory mask assembly. The breathable gas supply system includes a housing having an inspiration chamber and an exhalation chamber and a movable structure in communication with the inspiration and exhalation chambers. The movable structure moves in phase with a respiratory cycle of a patient. In one preferred embodiment, the breathable gas supply system includes a second movable structure, which moves in response to a phase of the respiratory cycle of the patient. In another one preferred embodiment, the breathable gas supply system is powered to assist the patient's respiratory effort.

Abstract: A mandibular advancement device used in the management of snoring, obstructive sleep apnea, TMD and bruxism, comprises a maxillary tray for receiving/retaining maxillary teeth, a mandibular tray for receiving/retaining mandibular teeth, and at least two advancement members/prongs located on the mandibular tray at the anterior-lateral regions thereof. The advancement members/prongs, when in use, contact the outer surface of the maxillary tray in an anterior-lateral region thereof, thereby advancing/retaining the mandible and tongue in a protrusive position. Raised occlusal surfaces/bite pads in a region contiguous and posterior to the advancement prongs allow a passive tongue retaining gap or space to be formed in the anterior and posterior regions of the device. A lingual retaining strap may be provided between opposite posterior portions of the mandibular tray to passively retain the tongue in a protruded, non-obstructive position.

Abstract: An intra-oral device comprising an upper splint (7100), a lower splint (7200) and a pair of lateral connecting rods (7300). Each connecting rod has a first rod end (7310) that connects to the lower splint and a second rod end (7320) that connects to the upper splint. The connecting rods (7300) are configured to maintain the mandible in an advanced position relative to the maxilla. The upper splint (7100) includes at least one upper gutter portion (7110) that retains the upper splint on the maxilla. The lower splint (7200) includes at least one lower gutter portion (7210) that retains the lower splint on the mandible. The thickness of the at least one upper gutter portion and/or the at least one lower gutter portion may vary across the profile of the teeth.

Abstract: An anti-snoring and sleep apnea device is disclosed which comprises a maxillary tray adapted for receiving upper teeth, the maxillary tray having a pair of shoulder structures with each of the shoulder structures having an adjustable expansion device and a movable boss member connected to the expansion device, with adjustment of each expansion device for moving each boss member away from each shoulder structure, the maxillary tray also having a polymer compound therein, and a mandibular tray adapted for receiving lower teeth, the mandibular tray having a pair of upstanding structural fins, each of the fins being adjacent to each of the boss members, with adjustment of each expansion device for moving the mandibular tray forward of the maxillary tray, the mandibular tray also having a polymer compound therein.

Abstract: An anti-obstructive airway dental orthotic is described. The orthotic includes a maxillary retainer and a mandibular retainer releasably attaching to a plurality of teeth of a wearer. The retainers are attached by at least one strut, either variable in length or of a plurality of lengths, which exert a forward force on the lower jaw, tending to advance the mandible relative to the maxilla. This advancement of the lower jaw promotes a less obstructed airway in the wearer, while fenestrations in the retainers may allow for greater comfort and tongue movement.

Abstract: The present invention describes an apparatus, a systems and a method for the treatment of obstructive sleep apnea. the treatment involves monitoring the position of the tongue and/or the force exerted by the tongue an electrical stimulation of the hypoglossal nerve to move the tongue into an anterior position or to maintain the tongue in an anterior position.

Abstract: The invention consists of a rapidly crosslinkable, two-component silicone elastomer together with a specially designed tray that serves as a form for the silicone resin and forms an integral portion of a dental appliance.

Abstract: Magnetic devices and implantation methods are provided for use in the treatment of obstructive sleep apnea. The devices include a sheet-like element having ferromagnetic qualities. The device may also include a permanent magnet attached to the sheet-like element by magnetic forces. The devices are implanted in soft tissue surrounding the airway and in tissue space beneath the pharyngeal wall to exert forces on and/or change the shape of the soft tissue. The magnetic devices may also include a bladder containing a magnetorheological fluid that stiffens soft tissue when exposed to a magnetic field.

Abstract: A variably automated tissue retention system generally comprises an oral appliance retractably coupled to a covering which is secured to an anterior portion of the tongue. As the subject moves their tongue naturally or sleeps and the tongue becomes hypotonic, the subject's tongue may move posteriorly. As the covering pulls the tongue anteriorly or maintains a position of the tongue, the base of the tongue may be inhibited or prevented from collapsing posteriorly against the pharyngeal tissue walls and thereby allow the subject to breathe normally by automatically increasing the suction pressure on the tongue to maintain securement of the covering to the tongue as the tongue moves posteriorly.

Abstract: Therapeutic delivery systems are provided which, in a first embodiment, contain a plurality of multiphase capsules in which first and second therapeutic agents are contained in separate phases within said multiphase capsules, and are disposed to deliver said first and therapeutic agents by at least two different delivery mechanisms.

Abstract: A chin strap includes a chin cup, side straps, and rear straps. The chin strap is used to urge the patient's jaw upwards and substantially close the patient's mouth while pressurized breathable gas is delivered to the patient's nose by the mask system.

Abstract: According to one embodiment, a breathing device includes an oral appliance arch, a post, and first and second masks that are separately adjustable relative to the oral appliance arch. The first mask defines a first interior space and is configured to deliver gas to a user's nose when the first mask is connected to a gas delivery device. The second mask defines a second interior space and is configured to be adjustably secured to the post and to form a substantial seal around the user's oral cavity when pressed against a portion of the user's mouth. The post is coupled to the oral appliance arch and is configured to adjustably secure the first mask relative to the oral appliance arch.

Abstract: A system and method for controlling a device to alleviate sleep apnea comprises determining whether a user of the device is asleep by a microcontroller operatively connected to the device. Using a sensor operatively connected to the microcontroller, it is determined whether a breathing anomaly of the user is detected while the user is asleep. An electromagnet operatively connected to the device generates an electromagnetic field to widen an airway of the user in response to detecting the breathing anomaly while the user is asleep.

Abstract: A test battery method and system for use in assessing auditory function (e.g., the screening or diagnosis of impairments, fitting of hearing aids, etc.) is provided which performs one or more auditory tests including, for example, an acoustic reflectance test. Such an acoustic reflectance test may be a reflectance tympanometry test that includes a feedback system to control static pressure in the ear canal. Such acoustic reflectance tests may be used alone or in combination with one or more other auditory tests. Further, for example, such a battery of tests may include middle-ear muscle reflex tests in combination with one or more other auditory or hearing tests.

Abstract: An adjustable mandibular advancement device has an upper plate for covering upper teeth of a human and a lower plate for covering lower teeth of the human. A magnetic closure mechanism is provided in the device in order to hold the upper plate in contact with the lower plate when the device is positioned in a person's mouth. The magnetic closure mechanism includes one or more magnets in the upper plate and one or more magnets in the lower plate. The magnets are positioned so that when the upper plate and lower plate are in contact, the lower plate pulls the person's lower teeth and lower jaw forward and down in order to reduce obstruction of an airway during sleep or physical activity such as sport. An adjustment mechanism between the plates allows the position of the lower plate relative to the upper plate to be adjusted.

Abstract: Devices, kits, and methods useful in the treatment of Obstructive Sleep Apnea (OSA) are described. Example devices include a jig, a first needle, a second needle, and a third needle. An example jig comprises a drill guide and a tongue depressor. A first needle comprises an elongate shaft that defines a bend and a curve. A second needle comprises an elongate shaft that defines a curve. A third needle comprises an elongate shaft that defines a curve.

Abstract: A system includes an apparatus and a controller, according to an embodiment. The apparatus is configured to maintain an airway of a subject open while the subject is sleeping by applying to the airway a pressure having a magnitude, and the controller is configured to cause the apparatus to change the magnitude of the pressure over a period that begins at a settable start time. For example, the system can be configured to treat a subject's sleep apnea with positive or negative pressure, and to function as an alarm clock by beginning to change the pressure magnitude at a settable start time, and to continue changing the pressure over a period with a settable duration (or settable stop time) to gently awaken the subject by the end of the period.

Abstract: A system and method are disclosed for the securement of tissue and in particular for placement of a tongue base suspension fiber for the treatment of obstructive sleep apnea. The system incorporates disposable connectors with releasable needles to facilitate the placement of fibers with minimal increase in suture site dilation or trauma.

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: An embodiment of a collar includes first and second pressure surfaces, and first and second sealing surfaces. The first pressure surface is configured for disposal over a first region of a throat of a subject having an airway, and the first sealing surface is configured to form around the first pressure surface a first seal with a first region of a neck of the subject. And the second pressure surface is configured for disposal over a second region of the throat, and the second sealing surface is configured to form around the second pressure surface a second seal with a second region of the neck. For example, the collar can be configured to generate multiple negative-pressure regions to treat a subject's sleep apnea.

Abstract: The intraoral mandibular advancing positive pressure apparatus utilizes mandibular advancement (or protrusion) therapy with CPAP therapy. The mandibular advancement appliance is fabricated to receive a portion of a person's upper and lower teeth when the patient bites down on the appliance. The mandibular advancement appliance advances the patient's mandible a predetermined amount. The mandibular advancement appliance contains a fluid communication pathway that provides for access to the patient's oral cavity. A CPAP device is in fluid communication with the fluid communication pathway and supplies a continuous positive pressure air supply. The utilization of mandibular advancement therapy with CPAP therapy reduces the amount of advancement necessary through mandibular advancement and eliminates the need for nasal involvement or a facial mask typically associated with CPAP therapy.

Abstract: A nasally inserted airway opening device with inflatable cuff is provided to treat obstructive sleep apnea. The airway opening device includes a hollow flexible tube extending between a proximal end and a distal end, and an inflatable cuff attached to the tube at or near the distal end. The inflatable cuff may be inflated and deflated via the tube. The inflatable cuff defines an interior through hole extending along the length thereof. When deflated, the inflatable cuff may be packed closely to the tube and may be inserted or removed through a nostril of a user. When inserted through the user's nostril and positioned in the user's oropharynx or naso-oropharynx and inflated, the inflatable cuff prevents soft tissue in the user's naso-oropharynx from collapsing toward the posterior pharyngeal wall while simultaneously allowing airflow through the through hole. A method for utilizing the airway opening device to prevent/treat sleep apnea is also provided.

Abstract: An intra-oral mandibular advancement appliance to be inserted in the mouth of a patient so as to maintain an open airway to the patient's throat and thereby improve breathing during sleep. The mandibular advancement appliance has particular application for use by those wishing to reduce the effects of snoring and/or sleep apnea. The appliance includes an upper tray assembly against which is seated the patient's teeth carried by his upper jaw and a lower tray assembly against which the patient's teeth carried by his lower jaw are seated. The lower tray assembly is mated to and slidably adjustable by the patient relative to the upper tray assembly. By virtue of the foregoing, the position of the patient's lower jaw can be selectively and continuously moved forward with respect to the position of the upper jaw to prevent an occlusion of the airway as the patient's condition changes over time.

Abstract: Methods and devices comprised of a collapsible insert member and shaping member for treating obstructive sleep apnea are described. The insert member is placed in the tongue or other tissue forming the airway of the patient and has a lumen to accommodate the shaping member. The shaping member is inserted into the insert member by the patient just prior to sleep and removed upon waking. A variety of shaping members are available to treat patients on an individual basis, i.e., to match their particular anatomic condition that is causing their apnea or snoring. The shaping member can be made from nitinol, stainless steel, or any other known biocompatible implant material capable of providing a change in the tissue response to stress.

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: 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 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: The present invention relates to methods for treating obstructive sleep apnea (OSA), alleviating a negative OSA symptom, reducing snoring, or improving quality of life in a subject, comprising administering to the subject an effective amount of a pharmaceutical composition comprising pyridostigmine before sleep. Also provided are related medicaments as well as methods for preparing the medicaments.

Abstract: Systems and methods for detecting an obstructive sleep apnea event are disclosed herein. The systems and methods may use an electrical output generating ionic polymer metal composite sensor attached to a region in an airway passage in an oral cavity. The electrical output may be wirelessly transmitted as a signal for indication of an obstructive sleep apnea event. The signal may be further analyzed for treatment of the obstructive sleep apnea event.

Abstract: Magnetic devices and implantation methods are provided for use in the treatment of obstructive sleep apnea. The devices include a sheet-like element having ferromagnetic qualities. The device may also include a permanent magnet attached to the sheet-like element by magnetic forces. The devices are implanted in soft tissue surrounding the airway and in tissue space beneath the pharyngeal wall to exert forces on and/or change the shape of the soft tissue. The magnetic devices may also include a bladder containing a magnetorheological fluid that stiffens soft tissue when exposed to a magnetic field.

Abstract: A method of forming oral orthotic systems (100) to position and/or stabilize a mandible of a patient includes providing an upper dental member (20) adapted to be placed in connection with upper dentition of the patient, providing a lower dental member (30) adapted to be placed in connection with lower dentition of the patient and providing a plurality of posterior mounting structures (40). Each of the posterior mounting structure is adapted to be attached to one of the upper dental member or the lower dental member at a posterior, buccal position thereon. Each of the posterior mounting structures includes an extending member (42) which includes a plurality of positions (44) at which one of a plurality of connectors (50) is attachable to the extending member. Force may be applied to the mandible of the patient via at least one of a plurality of different mechanisms via attachment of a component of the mechanism (120) to at least one of the posterior mounting structures.

Abstract: A magnetic force system uses a magnetic implant sized and configured to be inserted in the pharynx and another magnetic implant sized and configured to be inserted in the tongue, palate, or pharynx. The system establishes different regions of magnetic interaction between the two implants across the airway, attracting and repelling, such that attractive interaction in one region of the implants combines with repelling interaction in another region of the implants, to provide a “hinge” structure. Alternatively, a magnetic force system that uses three magnetic implants sized and configured to be inserted in the tongue, pharynx, and palate, respectively. The tongue implant is attracted to the palatal implant, and repels the pharyngeal implant, forming a modified “hinge” structure. Forces of magnetic attracting bring tissue together to form a magnetic hinge joint, providing an anchor to stabilize the regions where repelling forces work to separate tissue to keep the airway open.

Abstract: An orthotic obstructive sleep apnea treatment device is provided that includes a hyoid bone attachment element disposed to attach a ferric element to a hyoid bone, where the ferric element is disposed to face along a treatment vector from the hyoid bone, and the treatment vector is oriented relative to a sagittal plane of a human. The orthotic obstructive sleep apnea treatment device further includes an external orthotic neck device having a contoured housing with a shape disposed to conform about a neck of the human subject, where the housing includes a force delivery element disposed at an exterior-front neck region of the human subject and is disposed to provide an attractive force to the ferric element along the treatment vector. A force sensor is disposed to measure a force exerted on the hyoid bone, a skin contact pressure, tissue compression between the ferric element and the force delivery element.