Abstract: A system and method for treating and/or preventing is described for treating periodic breathing characterized by cyclical hyperventilation and hypoventilation, examples of which include Cheyne-Stokes respiration and central sleep apnea. The system could also be used in the treatment of other conditions involving an impairment of respiratory drive.

Abstract: A patient's pharyngeal wall is treated by inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the pharyngeal wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the treatment includes stabilization of at least a portion of the pharyngeal wall after compression of portions of the wall.

Abstract: A method for direct fabrication of an orthodontic device having tooth-fitting cavities, such as an aligner, using layer-by-layer printing of a single or multiple polymeric materials. The cavities of the appliance are defined by the boundaries of the multiple layers, encapsulating up to fourteen teeth of a patient, and shaped to apply a load to at least one tooth that is sufficient to cause movement of the tooth, and remodeling of the adjacent bone. A series of such appliances may be used to treat malocclusion of teeth, each directly manufactured appliance used in series to incrementally move one or more teeth from initial positions toward a desired final position. The appliance may be fabricated with a variety of disclosed materials, and may include auxiliary features for interaction with other orthodontic elements.

Abstract: An automated tissue retention system generally comprises an oral appliance retractably coupled to a covering which is secured to an anterior portion of the tongue. Once placed within a subject's mouth, the appliance may be maintained in a closed configuration while the subject's mouth remains closed. However, as the subject sleeps and the tongue becomes hypotonic, the subject's month typically opens during a sleep disordered event. The appliance may be actuated by the separation between the mandible and maxilla to have greater tension and thus retract or pull anteriorly the covering adhered to the tongue. 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 phryngeal tissue walls and thereby allow the subject to breathe normally.

Abstract: The invention relates to a device for splinting and/or maintaining a cavity, an organ duct and or a vessel in a human or animal body, said device including at least one compressible and self-expanding stent that is composed of at least three phases.

Abstract: A method of treating snoring and/or OSA in a subject in need of such treatment. The method includes crosslinking proteins of the subject's soft palate tissue or pharynx tissue. The crosslinking can occur by contacting the soft palate or pharynx tissue with a crosslinking reagent. In addition, the crosslinking can occur without heating, contracting or denaturing of the tissue, or any combination thereof.

Abstract: A pharyngeal airway having a pharyngeal wall of a patient at least partially surrounding and defining the airway is treated by selecting an implant dimensioned so as to be implanted at or beneath a mucosal layer of the pharyngeal wall and extending transverse to said wall. The implant has mechanical characteristics for the implant, at least in combination with a fibrotic tissue response induced by the implant, to stiffen said pharyngeal wall to resist radial collapse. The implant is implanted into the pharyngeal wall transverse to a longitudinal axis of the airway.

Abstract: A pharyngeal retractor device and implantation methods are provided for use in the treatment of obstructive sleep apnea. The device includes a retracting element and a tissue engaging element that promotes tissue ingrowth around or onto the retracting element. The device is implanted in tissue space beneath the pharyngeal wall to alter the shape of the wall. The device may be implanted through the oral cavity alone or by using a trocar or a hand-held delivery system to deliver the device through the pharyngeal wall. Alternatively, the device may be implanted using an open, direct visualization approach from the side of a patient's neck.

Abstract: An intraoral orthosis comprising a first shell and a second shell, said shells being connected together by an adjustable connection device, said adjustable connection device comprising two notched tabs that are arranged respectively on either side of one of said shells, each notched tab co-operating in adjustable manner with a respective adjustment housing, arranged correspondingly on either side of the other of said shells, the adjustment housings being molded integrally with said other shell, each adjustment housing being connected to said other shell by a foldable support structure.

Abstract: A nasal insert includes a user interface with a housing having a circumferential wall defining an interior passage. A valve is in communication with the interior passage and limits a fluid flow through the interior passage in at least one direction. An exterior surface of the housing is adapted to interface with a nasal vestibule of a user and define an exhalation flow path. Methods of using and assembling the nasal inserts also are provided.

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

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: 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: Systems for sizing oral applications include 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.

Abstract: A self-contained Autonomous Positive Air Pressure (APAP) device that treats sleep apnea by providing pressurized air intermittently or on demand. The self-contained device is inconspicuously designed as eyewear and does not require the user to be tethered to an air hose or power cord. The device also does not require the user to wear a face mask sealed to the user's face. Instead, the present invention comprises a system that is battery powered including pumps to pressurize a chamber or chambers that provides breathable air through electronically controlled pressure regulated valves that prevents upper airway obstruction.

Abstract: Slings, kits, and methods useful in the treatment of Obstructive Sleep Apnea (OSA) are described. An exemplary sling comprises a main body extending along a lengthwise axis and having first and second opposing ends, first and second opposing sides, and first and second opposing surfaces. Each end defines an end loop that defines a passageway extending through the main body. An exemplary method of treatment comprises creating two openings in the mandible of a patient; creating two longitudinal tunnels in the tongue of the patient; creating a transverse tunnel in the tongue of the patient; advancing a sling through the transverse tunnel; pulling each end of the sling through one of the longitudinal tunnels and through one of the openings in the mandible; pulling the tongue toward the front of the mouth or mandible; and securing the sling to a tissue to support the tongue in a new position.

Abstract: An oral device for temporary placement in a patient's oral cavity includes a base, a tongue-engaging member and a tongue pocket. Partial vacuums are separately drawn through the tongue-engaging member and the tongue pocket in order to advance and control the position of the tongue in order to clear the patient's airway to reduce sleep apnea or treat other conditions.

Abstract: A spine and neck support device adapted to support the anatomical structures in the cervical and upper thoracic spine when the user's neck is in flexion. A cushion conforms about the user's anatomical neck structures and rests on the upper chest of the user. The cushion has a chin support area that avoids contacting the user's chin when the user's head is in a neutral position and contacts the user's chin when the user's neck is in flexion. When the user's neck is flexed and the user's chin contacts the chin support area, the cushion unloads and supports the user's neck. At least one and preferably two straps are attached to the cushion and secure it to the user. The top is sloped downwards from back to front to maximize the user's downward field of vision. A groove in the posterior surface of the cushion accommodates the user's trachea/esophagus.

Abstract: A patient's obstructive sleep apnea is treated by identifying a patient with sleep apnea attributable at least in part to movement of a base of a tongue of the patient toward a pharyngeal wall of the patient. The tongue is stiffened by an implant sized to be placed within the tongue. A distal portion of the implant is sized to extend within the tongue from a first end near a mandibular-geniohyoid interface to a second end near a base of the tongue. A proximal portion is attached to the first end and adapted to be secured to a jaw bone of the patient following a period of healing after placement of the implant in the tongue.

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

Abstract: A tongue retaining device and a method of using the same are provided. The device includes an implant member configured to be anchored in a tongue, a dental plate configured to be worn upon mandibular teeth, and a coupling member couplable between the implant member and the dental plate to promote direct anterior displacement of the tongue. The tongue retaining device may be offered as part of a kit with a tongue-piercing device.

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: A removable intraoral apparatus for improving airway patency is described. Wearing the apparatus alters the position, configuration and freedom of movement of the tongue, the muscles of mastication, as well as the pharyngeal and facial muscles. The apparatus is useful for correcting snoring and/or obstructive sleep apnea due to intermittent closures or partial obstructions occurring in the oropharynx during sleep. The apparatus of the invention can improve various types of airway disorders and improve oral functions by changing the position, configuration and freedom of movement of selected portions of the tongue and mouth, reducing the resistance to air flow in the mouth and pharynx, re-orienting and reprogramming the muscles of the mouth and tongue, and maintaining a proper oral systemic balance.

Abstract: Methods and devices for the treatment of airway obstruction, sleep apnea and snoring are disclosed. In some embodiments, a glossal suspension system includes a tissue tensioner that includes a suture loop made of one or more sutures configured to suspend the tongue with at least one portion configured to extend laterally through the tongue, and a securement mechanism configured to be attached to a patient's mandible that includes one more adjustment assemblies for engaging the one or more sutures and adjusting tension on the suture loop. Various tethers and anchors that can be used with the glossal suspension system are also disclosed.

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 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: A jaw-joint protective device is provided for whitening and brightening a wearer's teeth while protecting the teeth, tongue, lips, jaw, and other delicate structures of the vital cranial triad (VCT) from injury and/or for supporting the condyle of the temporomandibular joint (TMJ) in a relatively fixed (stable) position thereby stabilizing the jaw and the VCT during head contact activity, exercise, physical rehabilitation, C-force acceleration, teeth grinding disorders and sleep apnea and or permit the components of a VCT disorder to be realigned for proper healing. This device is an over-the-counter purchased, boil and bite device for whitening at least one tooth while protecting the jaw-joint, providing maxillary and mandibular teeth seats for protection of the mouth and/or healing of the VCT.

Abstract: In certain embodiments, an apparatus for treating a breathing condition includes a body, a threaded member, a hook, and a receiver. The body comprises a front stop, a rear stop, and a guide extending between the stops. The threaded member couples between the stops and rotates relative to the body. The hook couples to the guide, comprises a threaded passage and an arm that engages a lower arch, and travels in a forward direction along the guide to adjust the position of the lower arch. The receiver couples to the lower arch and comprises a shelf that engages the arm of the hook. The apparatus may include an extender coupled to the receiver and providing a shelf that is more rearward than the shelf of the receiver. The apparatus may include a post that couples the apparatus to another device.

Abstract: A garment for the treatment of sleep apnea and/or snoring includes a member for attachment to an individual afflicted with sleep apnea and an elongate, position control member at the rear of the garment and extending outwardly therefrom. The elongate member is a continuous member having transversely spaced-apart side surfaces, and the side surfaces are joined to an outer wall of the position control member at elongate side edges. The side surfaces and/or side edges are located to engage a mattress or other sleeping surface when an individual wearing the garment is sleeping in a lateral position to aid in supporting the individual in a lateral position.

Abstract: A tongue and mandibular advancement device for pulling the jaw forward and keeping the tongue in an extended position includes upper and lower inserts conforming to upper and lower teeth respectively. A hook support is located on both sides of the upper insert at a forward position and a plurality of hook supports are located at a rearward position of both sides of the lower insert. Tension coil springs are fitted to each of the upper insert hook supports and to one of the plurality of lower hook supports. The plurality of lower insert hook supports provides discrete levels of tension force of the coil spring on each side of the appliance. A plastic tube may be fitted over the coil springs to prevent injury to the inside of a user's mouth. The upper and lower inserts each have a magnet that attracts a magnetizable member on or in a user's tongue to keep the tongue at an extended position.

Abstract: A garment for the treatment of sleep apnea and/or snoring includes a member for attachment to an individual afflicted with sleep apnea and an elongate, position control member at the rear of the garment and extending outwardly therefrom. The elongate member is a continuous member having transversely spaced-apart side surfaces, and the side surfaces are joined to an outer wall of the position control member at elongate side edges. The side surfaces and/or side edges are located to engage a mattress or other sleeping surface when an individual wearing the garment is sleeping in a lateral position to aid in supporting the individual in a lateral position.

Abstract: A device in connection with sleep apnoea, includes a dental splint (1) designed to engage with the jaws of the user in the position of use of the device and the device moreover includes elements (10, 11) for delivering air to the nostrils of the user from an external air source and a holder element (3) for supporting the elements (10, 11) for the delivery of air, the holder element (3) being connected to the dental splint (1). The holder element (3) is connected to the dental splint (1) by way of elements (7, 9) for adjusting the distance between the dental splint (1) and the holder element (3).

Abstract: An automated tissue retention system generally comprises an oral appliance retractably coupled to a covering which is secured to an anterior portion of the tongue. Once placed within a subject's mouth, the appliance may be maintained in a closed configuration while the subject's mouth remains closed. However, as the subject sleeps and the tongue becomes hypotonic, the subject's mouth typically opens during a sleep disordered event. The appliance may be actuated by the separation between the mandible and maxilla to have greater tension and thus retract or pull anteriorly the covering adhered to the tongue. 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 phryngeal tissue walls and thereby allow the subject to breathe normally.

Abstract: An oral orthosis includes a holder in the shape of a mouthpiece, including a curved arcuate trough-like upper section which receives a formable material. The formable material does not occupy the entire trough but rather includes voids between the formable material and the inner surfaces of trough of the holder to allow expansion of the formable material into the voids during the molding process when tooth pressure is placed on the formable material. This design results in elimination of the excess formable material which otherwise would require removal by trimming. Additionally, the formable material is placed in the trough in a configuration which includes indexing indentations along the centerline of the material, such that, during the molding process, the mouthpiece containing the formable material is easily centered along the edges of the user's teeth to provide a precise fitting.

Abstract: A nasal dilator capable of introducing separating stresses in nasal outer wall tissues has a resilient member and a pair of spaced-apart end surfaces which can be forced toward one another from an initial flat position of the dilator to thereby substantially reduce the direct spacing therebetween by an external spacing reducing force. This results in restoring forces in the dilator tending to return it to the original direct spacing between the end surfaces. Resilient members, which can be asymmetrical with respect to a centerline of the dilator that is parallel to the long axis of the dilator, have a spring rate which continuously diminishes from the centerline to the end surfaces. The edges of the resilient members are contiguous to the edge of the cushion layer so that adhesive on the cushion layer is at the same level as the bottom surface of the resilient members.

Abstract: A fixture is provided for attachment to a device to be inserted into a nasal cavity. Further, the fixture is a nasal cavity insertion device fixture formed of a wire rod. The fixture includes a first wire rod part, a second wire rod part, and a third wire rod part. The second wire rod part is connected to the first wire rod part and formed by folding back the wire rod so as to be opposed to the first wire rod part. The third wire rod part is connected to the second wire rod part and formed by bending the wire rod so as to be disposed oppositely to a side of the second wire rod part facing the first wire rod part.

Abstract: Systems and methods for detecting and treating 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 by a positive airway pressure system for treatment of the obstructive sleep apnea event.

Abstract: A nasal cavity insertion device is provided that includes a tubular main body part, at least one elastically deforming part disposed on the outer peripheral surface of the tubular main body part, and a water soluble holding part. The water soluble holding part holds the elastically deforming part in a diameter-reduced state.

Abstract: An adjustable dental device for use with a CPAP system in the treatment of sleep apnea and snoring is comprised of an upper bite block, a lower bite block having one or more tongue retainers, means for adjustably connecting the upper bite block to the lower bite block, and means for connecting the dental device to a CPAP system. The adjustable dental device is compatible with a variety of CPAP systems, including systems that utilize nasal inserts and systems that utilize a nasal mask.

Abstract: At least one elongated body is sized and configured for implantation in a desired orientation in a tissue region in an airway. An array of projections extends from the elongated body and is resiliently coupled to the elongated body. The array or projections is in a normally biased outward extending condition sized and configured to engage tissue and resist a reorientation of the elongated body within the tissue region out of the desired orientation after implantation of the elongated body in the tissue region. The array of projections is sized and configured to resiliently yield by flexing inward against the elongated body during implantation of the elongated body in the tissue region.

Abstract: A method of maintaining airway patency in an airway of a patient which includes the steps of implanting a device into tissue adjacent an airway, the device having a bioerodable material wound around a resiliently deformable body to temporarily maintain the deformable body in a stretched, deformed state, and permitting the bioerodable material of the device to bioerode to apply a force to maintain airway patency. The invention also provides devices for practicing the method.

Abstract: The treatment of snoring related sleep disorders require the knowledge of the location of origin of snoring in a patient. A method and device are provided for the determination of a location of origin of a primary vibration signal generated by snoring in an upper airway of a patient. At least two sensors are used to respectively detect the primary vibration signal and to generate respective intermediate signals. The sensors are spaced apart in a longitudinal direction of the patient's neck. The respective intermediate signals are processed to generate an output signal. The output signal is indicative of the location of origin.

Abstract: An oral orthosis includes a holder in the shape of a mouthpiece, including a curved arcuate trough-like upper section which receives a formable material. The formable material does not occupy the entire trough but rather includes voids between the formable material and the inner surfaces of trough of the holder to allow expansion of the formable material into the voids during the molding process when tooth pressure is placed on the formable material. This design results in elimination of the excess formable material which otherwise would require removal by trimming. Additionally, the formable material is placed in the trough in a configuration which includes indexing indentations along the centerline of the material, such that, during the molding process, the mouthpiece containing the formable material is easily centered along the edges of the user's teeth to provide a precise fitting.

Abstract: In certain embodiments, an apparatus for treating a breathing condition includes an oral appliance, a mask, and a tensioning device. The oral appliance is configured to receive at least some of a wearer's teeth and a mask. The mask is configured to deliver gas to the wearer. The mask includes a chamber configured to cover the wearer's mouth. The chamber is at least partially enclosed by an interior of the mask. The tensioning device couples the mask to the oral appliance and includes a flexible tension element at least partially disposed between the oral appliance and the mask and within the chamber. The flexible tension element is configured to apply a tensile force between the mask and the oral appliance.

Abstract: An apparatus for use in treating a breathing condition includes a first dental arch, a second dental arch, two bodies coupled to the first dental arch, and two receivers coupled to the second dental arch. The first dental arch is configured to receive at least some of a wearer's teeth. The second dental arch is configured to receive at least some of a wearer's teeth. Each body includes a front stop, a rear stop, a threaded member, and a hook. The threaded member is configured to be coupled between the front stop and rear stop of the body and configured to rotate relative to the body. The hook comprises a threaded passage configured to engage the threaded member, and an arm configured to engage a second dental arch. The hook is configured to travel between the front stop and rear stop of the body in response to rotational adjustment of the threaded member to adjust the lower dental arch relative to the upper dental arch.

Abstract: Systems and methods place a first magnetically interactive material in or on a tongue in an airway. The systems and methods place a second magnetically interactive material in or on tissue in a desired relationship with the tongue. The first and second materials magnetically interact to stabilize a preferred orientation of the tongue.

Abstract: An intra-oral device used for people that snore or have sleep apnea is designed to move a user's lower jaw forward relative to the user's immovable upper jaw and to prevent the user's mouth from inadvertently opening while sleeping. The device includes upper and lower appliances fitted to the user's respective upper and lower dental arches. The lower appliance possesses a partially embedded bracket. An adjustment element is integrated into the upper portion of the bracket. With the user's mouth closed and the upper and lower appliances positioned over the user's respective dental arches, the adjustment element is moved rearward by worm action into load bearing contact against the forward facing immovable vertical contact wall of the upper appliance. This action moves the lower appliance forward, and thus, the user's lower jaw with its anatomically attached tongue are also moved forward relative to the mouth which in turn opens the user's airway.

Abstract: A system for treating obstructive sleep apnea includes a body implantable in a soft palate, and a fastening element at a proximal end of the body for connecting the body with a hard palate. In one embodiment, the body is curved and has a convex top surface and a concave bottom surface. The curved body is adapted to support and/or change the shape of the soft palate for minimizing the likelihood of airway obstructions during sleep. The fastening element, secureable to the hard palate, includes at least one barb adapted to engage the hard palate for anchoring the body to the hard palate. In one embodiment, the body has a surface adapted to promote tissue in-growth. The implant body may be made of materials including nitinol, stainless steel, biocompatible polymers, temperature-sensitive materials, and shape memory materials.

Abstract: A mouth appliance for maintaining effective airflow in a wearer's airway comprises a frame formed to engage the wearer's upper and lower teeth to retain the frame in a selected position in the wearer's mouth in accord with the wearer's natural bite. A tongue depressor is mounted to the frame and formed to extend to a rear portion of the wearer's throat and exert pressure directly on the tongue in the area of the wearer's soft palate, thereby facilitating comfort and ease in occasional swallowing, while providing airflow effectiveness to prevent the wearer from snoring and experiencing sleep apnea.

Abstract: Whole-nose nasal respiratory devices and methods of making and using whole-nose nasal respiratory devices are described and illustrated herein. These devices are typically configured to be adhesively secured to a subject so that they engage both of the subject's nostrils and allow airflow from both nostrils to communicate with an airflow resistor. The airflow resistor is configured so that it inhibits exhalation through the nostrils more than it inhibits inhalation through the nostrils.