Abstract:
A custom, sized and fitted, integrated oral appliance is provided to treat breathing obstruction and restriction in the upper airway during sleep. Several novel features are integrated in a single device, which includes mandible repositioning to open the airway, and tongue restraint to prevent airway blockage. This device is comprised of a built-in air conduit to bypass nasal restriction and airway occlusion. In operation, the appliance is positioned in the oral cavity to firmly grip the upper and lower dentition using customized unshaped trays. Appliance positioning advances the mandible to an adjustable predetermined position and simultaneously restrains the tongue using flexible bristles attached to a spring-loaded, tongue-restraint-ac (TRAC) component. A hollow air conduit, built into the TRAC, spans the area between the users&#39; lips and soft palate. It facilitates the flow of self-heated, moisturized air directly to (and from) the oropharynx to bypass airway obstructions and/or nasal restrictions.

Description:
RELATED APPLICATIONS 
       [0001]    The present application is a continuation-in-part application of U.S. provisional patent application, Ser. No. 60/988,794, filed Nov. 18, 2007, for TONGUE CONTROL DEVICE TO SNORING AND SLEEP APNEA, by Elijah Walker, included by reference herein and for which benefit of the priority date is hereby claimed. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention application pertains to oral (i.e. intraoral) appliances for treating sleep-related breathing disorders. More particularly, this invention application pertains to an oral appliance to enhance breathing during sleep by preventing and alleviating upper airway obstruction and restriction resulting from sleep-related breathing disorders such as snoring, obstructive sleep apnea, obstructive sleep hypopnea, or upper airway resistance. 
       BACKGROUND OF THE INVENTION 
       [0003]    Sleep is a fundamental need and appears to be required for human survival. However, for many people diagnosed with sleep apnea, going to sleep can be a dreaded experience due to the lack of restful sleep. Sleep apnea (apnea meaning a cessation of airflow) is a relatively common and potentially life-threatening sleep disorder that impacts millions of people in the United States and around the world. 
         [0004]    Obstructive sleep apnea (OSA), obstructive sleep hypopnea, and upper airway resistance are characterized by upper airway abnormalities that result in airway collapse and complete or partial obstruction of airflow into the lungs. Upper airway (i.e. upper respiratory tract, or airway) abnormalities include: a smaller (than normal) airway cross-sectional area that subjects the pharynx to collapse; an enlarged tongue that can obstruct the airway by moving posteriorly (backward) into airway space during sleep; a retruding jaw that can increase tissue pressure surrounding the airway and subject it to collapse; an enlarged soft palate that can impinge on airway space when breathing; or compromised pharyngeal dilator muscles that fail to keep the airway open when inhaling, causing momentary obstruction of airflow. Fortunately, the brain usually detects this inability to breathe and briefly awakens the individual to reopen the airway. Unfortunately, these continuous disruptions in breathing have also been associated with increased blood pressure, stroke, and diabetes as well as other chronic disorders including death. Due to the variety of airway abnormalities that cause obstruction, and individual needs and preferences, no single solution has been found to be acceptable to all who suffer from OSA. 
         [0005]    Related Art 
         [0006]    Powered Apparatus Approaches 
         [0007]    Various apparatus-based approaches (e.g. non-surgical and non-pharmacological) have been developed to treat snoring and/or sleep apnea which in general can be divided into two categories: 1. apparatus that require a power source and 2. apparatus that do not require a power source. Apparatus that require power sources (usually involving forced ventilation) include medical devices, such as Continuous Positive Airway Pressure (CPAP) devices, and negative pressure apparatus. Although CPAP devices have success rates of approximately 82.7% (Hoekema A, et al, “Obstructive Sleep Apnea Therapy”, J Dent Res. 2008 September; 87(9):882-7), they suffer from low user compliance estimated to be approximately “25-50% with patients typically abandoning therapy during the first 2 to 4 weeks of treatment”; (Zozula, R. et al, Compliance with continuous positive airway pressure therapy . . . ”, Current Opinion in Pulmonary Medicine. 7(6):391-398, November 2001). Those who dislike CPAP give many reasons including: mask discomfort, difficulty adapting to the pressure, dislike being tethered to a machine, nasal irritation, sore throat, and allergies. 
         [0008]    Non-Powered Apparatus Approaches: Oral Appliances 
         [0009]    Non-powered apparatus (typically oral appliances) offer additional solutions for snoring or sleep apnea. Oral appliances can generally be separated into two types: Mandibular Repositioning Appliances, (e.g. U.S. Pat. No. 6,729,335, Halstrom, May 4, 2004) and Tongue Retainer appliances. Mandibular Repositioning Appliances (MRAs, sometimes known as mandibular advancement appliances) purport to reposition the mandible anteriorly to further open the airway to prevent its obstruction. 
         [0010]    Tongue Retainer (TR) appliances are not used very often, and in general, they either use a medium such as a vacuum to hold/pull the tongue or they use a direct contact device to hold/restrain the tongue during sleep. Vacuum-type TRs may be recommended when users lack adequate teeth or when the lower jaw can&#39;t be advanced. One vacuum-type TR, (U.S. Pat. No. 4,676,240, Gardy, Jun. 30, 1987) purports to provide a way to hold the tongue forward in a chamber that generates a vacuum when the tongue begins to fall and also purports to allow oral breathing. 
         [0011]    A direct contact type of TR (e.g. U.S. Pat. Application Pub. 2008/0041396 A1, Lucker, Feb. 21, 2008) purports to restrain the tongue using a rigid flat tab at the back of the tongue and uses another rigid tab-like component in the area of the soft palate. Another TR appliance (e.g. U.S. Pat. No. 6,766,802, Keropian, Jul. 27, 2004) purports to hold the tongue down using a rigid bar-like device. 
         [0012]    Shortcomings of Prior Art 
         [0013]    Prior art offers a variety of purported solutions along with significant drawbacks. Oral appliances (MRA, TR, etc.) in general have treatment success rates of approximately 54%, and compliance rates of 56-68%. (Hoffstein V, “Review of oral appliances for treatment of sleep-disordered breathing”, Sleep Breath. 2007 March; 11(1):1-22). MRA users have experienced mixed success, with some patients experiencing potentially harmful dental changes and/or temporomandibular joint pain. A study reported that with long term use (88.4+/−26.7 months) there were significant dental changes including “mandibular arch width increased more than maxillary arch width” (Chen H, et al, “Three-dimensional . . . Part 2. Side effects of oral appliances . . . ”, Am J Orthod Dentofacial Orthop. 2008 September; 134(3):408-17). 
         [0014]    Pre-fabricated thermoplastic (boil and bite) MRAs have been determined to be ineffective and “cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy” (Vanderveken, O M, et al, “Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea.”, Am J Respir Crit Care Med 2008; 178:197-202). 
         [0015]    Vacuum-type TR devices that purport to hold the tongue suffer from low compliance rates, reported to be 25% in one study (e.g. 75% non-compliance) and low efficacy i.e. low treatment success, (Schonhofer, B et al, “Value of various intra- and extraoral therapeutic procedures for obstructive sleep apnea and snoring”, Med Klin (Munich, 1997 Mar. 15; 92 (3):167-74 9173209). 
         [0016]    Part of the difficulty of restraining or holding the tongue is due to the typically wet, slippery nature of the tongue. Saliva is continuously produced in the oral cavity at a rate of approximately 1.5 liters per day, which increases when foreign objects are added. Additionally, glycoproteins in saliva (which provide its lubricative characteristic), increase the difficulty of holding the tongue. 
         [0017]    Thus there remains a need for a treatment apparatus that does not require forced ventilation, or being tethered, and is effective in restraining intraoral tissue including the tongue and or mandible without adverse effects such as discomfort, pain, tissue dysfunction, or injury. 
         [0018]    It would be advantageous to provide an effective oral appliance to maintain upper airway patency during sleep, thus preventing obstructions and snoring without adverse effects. 
         [0019]    It would be advantageous to provide an oral appliance to maintain airway patency comprising mandible repositioning and tongue restraint to improve treatment effectiveness and comfort. 
         [0020]    It would be advantageous to provide an oral appliance comprising a comfortable, easily adjustable mandible repositioning method. 
         [0021]    It would be advantageous to provide an oral appliance comprising bristles to retain the tongue without excessive force. 
         [0022]    It would be advantageous to provide an oral appliance comprising a built-in air conduit to provide breathable air via the oral cavity while keeping the mouth closed thus preventing and bypassing obstructions and nasal restrictions. 
         [0023]    The aforementioned and other advantages, features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will be more apparent upon consideration of the following detailed description and claims, with reference to the accompanying drawings; all of which form a part of this specification, wherein like reference numerals designate corresponding elements in the various figures. It should also be understood that the drawings are for the purpose of illustration and description and are not intended to specify the limits of the invention. Nor is the size, scale or orientation of elements shown in the drawings intended to reflect actual size, scale or proportion. Additionally, the method of the present invention includes any description herein of how the apparatus functions or is used, irrespective of whether such description is specifically identified as method disclosure. 
       SUMMARY OF THE INVENTION 
       [0024]    In accordance with the present invention, a unique oral appliance integrates several novel features to treat sleep-related breathing disorders associated with upper airway abnormalities. The appliance firmly grips the users&#39; upper and lower dentition using custom fitted u-shaped trays (i.e. mouthpiece). An adjustable bracket attached to the trays facilitates movement of the lower tray to advance the mandible to prevent airway closure. The tongue-restraint-ac (TRAC) component, containing a hollow middle, is attached to the bracket in a cantilevered fashion to apply a compressive spring-loaded force to the dorsal surface of the tongue. Novel flexible bristles, built into the bottom of the TRAC, (proven to be effective in a reduction to practice) engage the tongue to prevent it from obstructing the airway. The hollow middle allows breathable air to flow (via the oral cavity) directly to the airway, bypassing nasal restrictions and/or airway obstructions. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which: 
           [0026]      FIG. 1  is a left sectional view of an anatomical cross-section of a normal human upper airway including nasal cavity, oral cavity, and pharynx with arrows illustrating normal nasal airflow; 
           [0027]      FIG. 2  is a left sectional view of an anatomical cross-section illustrating occlusion of the pharynx that can occur during obstructive sleep apnea; 
           [0028]      FIG. 3  is a rear perspective view of an integrated oral appliance  26 ; 
           [0029]      FIG. 4  is a left sectional view of an anatomical cross-section of a human upper airway (similar to  FIG. 1 ), illustrating a cross-section of 26 positioned in the oral cavity, firmly gripping the upper and lower dentition, and interacting with the tongue to prevent it from obstructing the airway; 
           [0030]      FIG. 5  is a front exploded perspective view of an integrated oral appliance  26  illustrating all elements; 
           [0031]      FIG. 6  is a left front perspective view of an integrated oral appliance  26  with an arrow illustrating advancement (repositioning) of the lower-tray  24  in an anterior direction; 
           [0032]      FIG. 7  is a left sectional view of an anatomical cross-section (similar to  FIG. 4 ) illustrating anterior advancement of lower tray  24  to reposition the mandible from a neutral position, to further open the airway, and prevent occlusion within the pharynx; 
           [0033]      FIG. 8  is a top front perspective view of a tongue-restraint-ac  20 ; 
           [0034]      FIG. 9  is a front exploded perspective view of a tongue-restraint-ac  20  with heat-moisture-filter  28  removed; and 
           [0035]      FIG. 10  is a front bottom perspective view of a tongue-restraint-ac  20 . 
       
    
    
       [0036]    For purposes of clarity and brevity, like elements and components will bear the same designations and numbering throughout the Figures. 
       DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0037]    Accordingly, the preferred embodiment of the present invention comprises several unique features designed to overcome upper airway abnormalities experienced by those who suffer from sleep-related breathing disorders such as obstructive sleep apnea and snoring. Specifically, the integrated oral appliance  26  treats obstructive sleep apnea and snoring by preventing or mitigating airway closures by advancing the mandible to further open the airway and by retaining the tongue using flexible bristles. The present invention, as well as a preferred mode of use, objects and advantages, can be understood by referring to the following detailed description when read in conjunction with the accompanying drawings, wherein: 
         [0038]      FIG. 1  is an anatomical cross-section of a normal human upper airway including nasal cavity, oral cavity, and pharynx with arrows illustrating nasal airflow. 
         [0039]      FIG. 2  is a view similar to  FIG. 1 , illustrating occlusion of the pharynx that can occur during obstructive sleep apnea. 
         [0040]      FIG. 3  is a rear perspective view of an integrated oral appliance  26 . 
         [0041]      FIG. 4  is a left sectional view of an anatomical cross-section of a human upper airway (similar to  FIG. 1 ) illustrating a cross-section of integrated oral appliance  26  positioned in the oral cavity, firmly gripping the upper and lower dentition, and interacting with the tongue to prevent it from obstructing the airway. 
         [0042]      FIG. 5  is a front exploded perspective view of (integrated oral appliance  26 ) illustrating all elements. 
         [0043]      FIG. 6  is a left front perspective view of integrated oral appliance  26  with an arrow illustrating advancement (repositioning) of lower-tray  24  in an anterior direction. 
         [0044]      FIG. 7  is a left sectional view (similar to  FIG. 4 ) illustrating anterior advancement of lower-tray  24  to reposition the mandible from a neutral position, to further open the airway, and to prevent occlusion within the pharynx. 
         [0045]      FIG. 8  is a top front perspective view of the tongue-restraint-ac  20 . 
         [0046]      FIG. 9  is a front exploded perspective view of tongue-restraint-ac  20  with heat-moisture-filter  28  removed. 
         [0047]      FIG. 10  is a front bottom perspective view of a tongue-restraint-ac  20 . 
         [0048]    In operation, an appropriate medical professional (e.g. physician, dentist, etc.) initially adjusts integrated oral appliance  26  after the u-shaped upper-tray  12  and the u-shaped lower-tray  24  have been custom molded and fitted to conform to the users&#39; dentition. Initial adjustment includes mandible repositioning and tongue-restraint-ac  20  adjusted to fit the users&#39; tongue. In daily practice, prior to falling asleep, the user positions the integrated oral appliance  26  inside their oral cavity so that the u-shaped upper-tray  12  and lower-tray  24  firmly grips both upper and lower dentition. Both u-shaped trays are made from a biocompatible resilient material (e.g. thermoplastic such as ethylene vinyl acetate, or medical-grade silicone rubber, etc.) of a definite thickness to be strong enough to firmly grip the users&#39; dentition, and firm enough to contain a built-in guide-bracket  10 . Both u-shaped tray&#39;s also have sides to contain the flow of air to the center of both tray&#39;s. This prevents air from entering the oral cavity from the sides of both trays and restricts the air to flow through the open channel within the tongue-restraint-ac  20 . In alternate embodiments other attachment means to the upper or lower dentition can comprise orthodontic materials including stainless steel, nickel titanium, polymers, or attachment means outside the oral cavity. In another embodiment the lower-tray  24  can also be fixed relative to the upper-tray  12 . 
         [0049]    The upper-tray  12  contains a guide-bracket  10  built into the back of the tray and attached to the inner surfaces of the left and right sides of the tray so as to form a bridge between the sides. The guide-bracket  10  supports and guides the flex-bracket  16  along an anterior-posterior path. 
         [0050]    The guide-bracket  10  is made from a material that is biocompatible, rigid, and shaped to fit comfortably inside the oral cavity. The material can be polymeric, stainless steel, or any appropriate material that will functionally perform and will not rust or degrade when exposed to the environment inside the oral cavity. The guide-bracket  10  contains an opening in the middle to allow fastener-g  14  to connect the guide-bracket  10  to the flex-bracket  16  and fastener-fb  18 . 
         [0051]    The flex-bracket  16  is permanently attached to the rear of lower-tray  24 , or in an alternate embodiment it can be removably attached. During initial setup, a medical professional adjusts lower-tray  24  (guided by the flex-bracket  16 ) in an anterior direction, to a position that is sufficient to prevent airway collapse without causing adverse effects. The flex-bracket  16  serves three functions. One function is to enable the attached lower-tray  24  to move the mandible to increase airway size. A second function is to provide a surface capable of generating a spring-loaded, compressive force when flexed. This surface also serves as the point of attachment (third function) for the tongue-restraint-ac  20 . The tongue-restraint-ac  20  is attached to the flex-bracket  16  in a cantilevered fashion at its mid-section that contains a slot for adjustment. The tongue-restraint-ac  20  contains flexible bristles built into (e.g. molded, implanted) its bottom rear surface to engage the dorsal surface of the tongue. The bristles maintain contact with the tongue under a compressive force that is sufficient to keep the bristles engaged with the tongue to properly restrain it, but not excessive to cause pain or injury. The bristles can be made from a polymeric material or another biocompatible appropriate material. In an alternate embodiment the bristles can also be made using hollow fibers to allow time-released treatment solutions to flow into the dorsal surface of the tongue to treat other medical or nutritional conditions. In an alternate embodiment other materials can be used to engage the tongue. 
         [0052]    The flex-bracket  16  is made from a material that is biocompatible, lightweight, strong enough to perform said function, and able to endure multiple flexures over the lifetime of integrated oral appliance  26 . The material can be polymeric, stainless steel or any appropriate material(s) that will not rust or degrade when exposed to the environment inside the oral cavity. The spring-force range exerted by the flex-bracket  16  can be fixed or adjustable in an alternate embodiment. In alternate embodiments, the present invention can comprise a variety of spring types to exert the required force including leaf springs, torsion springs, etc. 
         [0053]    The flex-bracket  16  contains an appropriately sized opening (e.g. slot) in the middle of the top surface to allow anterior-posterior adjustment and allow fastener-g  14  and fastener-fb  18  to connect the guide-bracket  10  to the flex-bracket  16 . The flex-bracket  16  is appropriately shaped to enable it to be moved within the guide-bracket  10  in order to move the mandible. 
         [0054]    The tongue-restraint-ac  20  comprises front, middle, and rear sections that are inter-connected to form an internal open conduit to allow passage of breathable air to bypass potential nasal restrictions and or airway obstructions. The air conduit extends from the front section of the tongue-restraint-ac  20  to the rear section so that in one embodiment it will be positioned between the lips of the user and a location near the soft palate in the oral cavity. For example, in the event of nasal restriction, the user telescopically advances the front section to position it slightly beyond the front of the u-shaped trays so that the user&#39;s lips can surround it. Airflow within the air conduit occurs naturally as the user inhales and exhales. When the user inhales, a negative pressure is developed within the pharynx (near the rear of the tongue-restraint-ac  20 ), causing air to flow from higher pressure (atmospheric pressure) outside the user&#39;s oral cavity directly to the user&#39;s pharynx. Airflow is reversed when the user exhales. Since the mouth is held closed via the unshaped tray attachments to the upper and lower dentition, no untoward effects due to the oral cavity airflow should occur. If oral airflow is not required, the front of the tongue-restraint-ac  20  remains in the retracted position within the dimensions of the front of the u-shaped trays that are covered by the user&#39;s lips during sleep. In alternate embodiments the air conduit can be made in different forms and shapes including round tubes, or, or in another embodiment the air conduit can be eliminated if not required, or in another embodiment air can also flow via other channels. 
         [0055]    The rear section of the tongue-restraint-ac  20  also has an opening in its top surface to allow a heat-moisture-filter  28  to be inserted into the air conduit to provide heat and moisture to inspired air. The heat-moisture-filter  28  is also made to be changed on a daily basis. The heat-moisture-filter  28  can also be replaced by a solid filter to block airflow. In an alternate embodiment, the tongue-restraint-ac  20  can be provided without the heat-moisture-filter  28 . 
         [0056]    The middle section of the tongue-restraint-ac  20  is made of a rigid material (e.g. polymer) and includes a slot in the middle (referred to above) that is open at the top and bottom. An appropriate fastener-trac  22  is used to connect the tongue-restraint-ac  20  to the flex-bracket  16 . The slot enables the tongue-restraint-ac  20  to be adjusted for proper positioning on the dorsal surface of the tongue. 
         [0057]    The heat-moisture-filter  28  contains an outer shell made from a rigid material (e.g. biocompatible polymer) and an inner corrugated paper rolled to fit within the outer shell. The paper is made of a material suitable to absorb heat and moisture from expired air and release heat and moisture into inspired air. The paper can be made from a cellulose material or another appropriate material with heat/moisture characteristics. Also, in an alternate embodiment, if the user does not want air to flow through the tongue-restraint-ac  20  then a solid material can be substituted for the corrugated material to prevent airflow. In another alternative embodiment, a treatment can also be added to the enclosed filter material to provide for other medical or nutritional needs, etc. 
         [0058]    The front section of the tongue-restraint-ac  20  provides an entrance to allow air to enter and leave the tongue-restraint-ac  20  during inspiration and expiration. This section is made using a sufficiently flexible material to allow the tongue-restraint-ac  20  to flex within the confines of the upper-tray  12  and lower-tray  24  in concert with superior-inferior tongue movement. 
         [0059]    Thus, it can be seen from the above illustrative embodiments that key elements of the integrated oral appliance  26  interact with upper airway tissue to treat upper airway abnormalities that cause obstructions during sleep. When positioned in a user&#39;s mouth (oral cavity), the integrated oral appliance  26  restrains the tongue, preventing the tongue from moving into airway space; moves the mandible in an anterior (forward) direction to open the airway; and reduces tissue pressure to improve airflow. The present invention also provides an air conduit that&#39;s built into the tongue-restraint-ac  20  to bypass nasal restrictions and or airway obstructions if they occur. To prevent inspired air from cooling and drying the pharynx, the tongue-restraint-ac  20  contains a heat-moisture-filter  28  that captures the heat and moisture from the expired air and releases heat and moisture to the drier inspired air. After use, the user removes the integrated oral appliance  26  from the oral cavity. Appropriate means are also used to clean the integrated oral appliance  26 . 
         [0060]    In an actual reduction to practice the present invention, involving a moderate OSA condition, eliminated snoring and airway obstructions and raised oxygen saturation from 87% (without the integrated oral appliance  26 ) to 100% using the integrated oral appliance  26 . 
       Additional Embodiments 
       [0061]    It should be obvious to those skilled in the art that there are a wide variety of changes that can be made to either the integrated oral appliance  26  or it&#39;s method of manufacture. In one alternate embodiment, the present invention can be made with only one of the key features such as with tongue restraint only or with mandible advance only. In another embodiment tongue restraint can be accomplished with attachment to upper dentition or lower dentition using either the upper-tray  12  alone or the lower-tray  24  alone. Tongue restraint can also be accomplished without an internal air conduit if an alternate breathing passage is not required. In other embodiments there can be variations in adjustable features such as adjustable spring force or the type of spring used. In another embodiment the bristle element can be replaceable to accommodate wear or made out of a different material that also has non-slip properties. In other embodiments there can be variations in the method of mandible adjustment. 
         [0062]    Particular embodiments of the present invention have been presented for purposes of illustration and description, and are not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those skilled in the art. The preferred embodiment was chosen and described in order to best explain the principles of the invention, the basic and practical application, and to enable others of ordinary skill in the art to understand the invention with various embodiments and various modifications as are suited to the particular use contemplated.