Abstract:
A dental appliance for the treatment of sleep disordered breathing. It addresses vibration and collapse of the soft palate, obstruction of the upper airway by the tongue and problems caused by retro/or micro-gnathia. The device includes upper trays, lower trays, and channels for providing positive or negative air pressure through the device.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of priority of U.S. provisional application No. 62/048,336, filed Sep. 10, 2014, the contents of which are herein incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to mandibular advancement devices and, more particularly, to a mandibular advancement device with positive air pressure. 
         [0003]    Obstructive sleep apnea syndrome many times does not respond to positive airway pressure or in certain circumstances, excessive pressures are required. Current mandibular advancement devices are limited to mild to moderate cases of obstructive sleep apnea syndrome. Current mandibular advancement devices can lead to bite change, jaw pain and shifting of teeth. 
         [0004]    As can be seen, there is a need for a mandibular advancement device with positive air pressure, that addresses vibration and collapse of the soft palate, obstruction of the upper airway by the tongue and problems caused by retro/or micro-gnathia. 
       SUMMARY OF THE INVENTION 
       [0005]    In one aspect of the invention, a mandibular advancement device with positive air pressure includes, an upper tray and a lower tray, wherein at least one of the upper tray and the lower tray comprises a plurality of hollow channels; at least two straps, wherein the straps connect the upper tray to the lower tray; and at least one airway tube in fluid communication with said plurality of hollow channels. 
         [0006]    In another aspect of the invention, the at least one airway tube further comprising multiple branches, wherein each branch enters through one of the plurality of hollow channels. 
         [0007]    A further aspect of the invention includes, adjustable length straps and straps that are hingedly connected to a post extending from an aft portion of the upper tray and lower tray. 
         [0008]    In certain embodiments, the hollow channels have openings extending to an inner surface of the at least one of the upper tray and said lower tray. Further, the hollow channels may also comprise an opening at an aft end of the at least one of said upper tray and said lower tray. 
         [0009]    An aspect of the invention also includes a mandibular advancement device with positive air pressure having an upper tray and a lower tray, with a hollow channel defined in at least one of the upper tray and said lower tray; at least two straps connect the upper tray to the lower tray; and at least one airway tube in fluid communication with said hollow channel. The hollow channel has a plurality of openings to an inner surface of the tray of mandibular advancement device. The hollow channel may also have an opening at an aft end of said tray and may further include a hollow channel is defined in each of said upper tray and said lower tray. 
         [0010]    In a further aspect, the mandibular advancement device is provided a first airway tube in fluid communication with a hollow channel in the upper tray, and a second airway tube is in fluid communication with the hollow channel in the lower tray. 
         [0011]    In another instance of the present invention, the upper tray and lower tray may also be formed to an impression of a patient&#39;s teeth. 
         [0012]    These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1 : is a perspective view of an embodiment of a mandibular advancement device 
           [0014]      FIG. 2 : is an exploded view of the an embodiment of a mandibular advancement device 
           [0015]      FIG. 3 : is a section view of the invention, taken along line  3 - 3  in  FIG. 1 , illustrating the exemplary movement of negative airflow through the lower mouthpiece  10  channels 
           [0016]      FIG. 4 : is a section view of the invention, taken along line  4 - 4  in  FIG. 1 , illustrating the exemplary movement of positive airflow through the upper mouthpiece  10  channels 
           [0017]      FIG. 5 : is a side view of the invention, illustrating its placement on the user&#39;s teeth  78   
           [0018]      FIG. 6 : is a side view of the invention, illustration the adjustment of strap  14   
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0019]    The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims. 
         [0020]    Broadly, an embodiment of the present invention provides a mandibular advancement device with positive air pressure comprising: an upper tray and a lower tray, wherein at least one of the upper tray and the lower tray comprises a plurality of hollow channels; at least two adjustable components, wherein the adjustable components connect the upper tray to the lower tray; and an air tube comprising multiple branches, wherein each branch enters through one of the plurality of hollow channels. 
         [0021]    As is illustrated in  FIGS. 1 through 6 , a device may include an upper mouthpiece  10  and a lower mouthpiece  14  each having a front end and two back ends. The upper mouthpiece  10  and the lower mouthpiece  12  may be connected by at least two straps  14 . The straps  14  may each include holes  16  at the ends thereof, which are pivotally attached to an upper mouthpiece strap post  18  and a lower mouthpiece strap post  20  extending from an outer surface and proximal to an aft end of the respective upper and lower mouthpieces. The straps  14  may be placed along approximately opposite sides of the upper mouthpiece  10  and the lower mouthpiece  12 . The upper mouthpiece  10 , the lower mouthpiece  12 , and the at least two straps  14  may function as a mandibular advancement portion of the device. 
         [0022]    The lower mouthpiece  12  may have at least two hollow channels, a left lower channel  24  and a right lower channel  30  that each run from the front end to one of the back ends of the lower mouthpiece  12 . As may be seen in reference to  FIGS. 2 and 3 , left lower channel  24  extends between a left lower front channel opening  22  to a left lower rear channel opening  26 . A plurality of left lower side channels  25  may extend from an left lower side channel openings  26  on an inner surface of the lower mouthpiece  12  and left lower channel  24 . In like manner, the right lower channel  30  extends from a right lower front channel opening  28  at a front end of the lower mouthpiece  12  to a right lower rear channel opening  32 . Lower mouthpiece  12  may include a plurality of right lower side channels  31  extending from right lower side channel openings  33  on an inner surface of the lower mouthpiece  12  and the right lower channel  30 . 
         [0023]    The upper mouthpiece  10 , may have at least two hollow channels, a left upper channel  48  and a right upper channel  58  that each run from the front end to one of the back ends of the upper mouthpiece  10 . As may be seen in reference to  FIGS. 2 and 4 , left upper channel  48  extends between a left upper front channel opening  46  to a left upper rear channel opening  52 . A plurality of left upper side channels  50  may extend from a left upper side channel opening  56  on an inner surface of the upper mouthpiece  10  and left upper channel  48 . In like manner, the right upper channel  58  extends from a right upper front channel opening  54  at a front end of the upper mouthpiece  10  to a right upper rear channel opening  62 . Upper mouthpiece  10  may include a plurality of right upper side channels  60  extending from right upper side channel openings  64  on an inner surface of the upper mouthpiece  10  and the right upper channel  58 . 
         [0024]    As best seen in reference to  FIGS. 1 and 3 , a lower central airway tube  34  may have branches defining a left lower airway tube  36  and right lower airway tube  38  that each may operatively connect the lower central airway tube  34  with the respective left and right channels  24 ,  30  via their associated channel openings  22 ,  28 . 
         [0025]    As best seen in reference to  FIGS. 1 and 4 , an upper central airway tube  66  may have branches defining a left upper airway tube  68  and right upper airway tube  70  that each may operatively connect the upper central airway tube  66  with the respective left and right channels  48 ,  58  via their associated channel openings  46 ,  54 . 
         [0026]    As may be seen with reference to  FIGS. 3 and 4 , a source of low flow positive airway pressure  84  or oxygen may send pressurized air  84 , and/or supplemental oxygen or the like through the central airway tube  66  to the hypopharynx. Similarly a source of low flow negative pressure air  82  may be applied to the lower central airway tube  34  to evacuate air from the hypopharynx. As will be appreciated and as illustrated in reference to  FIG. 1 , connections between the pressurized  84  or negative airflow  82  sources and the respective upper  66  or lower  34  central airway tubes may be reversed. 
         [0027]    According to another aspect of the mandibular advancement device, the upper mouthpiece  10  and the lower mouthpiece  12 , may extend the mandible  80  forward while the air channels may force positive pressure  84  toward the hypopharynx. Both the advancement of the mandible  80  and the addition of the positive pressure  84  may be included within one device. 
         [0028]    The device may be produced by taking mold templates of an individual&#39;s top and bottom teeth  78 . In certain embodiments, a generic sized mold may be made for temporary applications. The upper mouthpiece  10  and the lower mouthpiece  12  may be linked by a mechanism that may allow adjustment to move the mandible  80  forward. In certain embodiments, the lower mouthpiece  12 , the upper mouthpiece  10 , or both the upper mouthpiece  10  and the lower mouthpiece  12  may include the hollow channels  24 ,  25 ,  30 ,  31 ,  48 ,  50 ,  58 , and  60  that may allow air to pass through the mandibular advancement device and exit at the back end positioned toward the back of the mouth (i.e., oropharynx/hypopharynx). The hinged straps  14  may be any number of variations or simply a component to link the upper mouthpiece  10  and the lower mouthpiece  12  of the mandibular advancement device. In certain embodiments, a tongue retainer may be added to further improve the ability of the device to keep the airway (i.e., oropharynx/hypopharynx) open. 
         [0029]    The straps  14  between the upper mouthpiece  10  and the lower mouthpiece  12  of the mouthpiece (i.e., mandibular advancement device) may be any number of variations in order to link and set the upper mouthpiece  10  and the lower mouthpiece  12  together; and adjustable to move the lower mouthpiece  12  forward. The air channels for one or both of the upper mouthpiece  10  and the lower mouthpiece  12  may be arranged in a variety of number and configurations in order to allow air to enter and exit the upper mouthpiece  10  and the lower mouthpiece  12 . 
         [0030]    The channels in the upper and lower mouthpieces can be used together or separately. Moreover, negative and positive pressure or supplemental oxygen can be used interchangeably and at the same time in both the upper  10  and lower  12  mouth pieces. For example, negative pressure can be utilized in the lower mouth piece  12  for the purpose of tongue retention. In this case, the suction provided at the left and right side openings  29 ,  31  will retain the tongue in position against an inner surface of the lower tray  12 . Simultaneously, positive pressure and/or supplemental oxygen can be delivered via the upper tray  10  to ‘push’ the soft palate and hypo-pharynx open. The upper and bottom trays  10 ,  12  can be used separately in order to utilize only positive or negative pressure and/or supplemental oxygen. Or they can be connected by an adjustment strut to also engage for mandibular advancement. 
         [0031]    By utilizing mandibular advancement with positive and/or negative airway pressure with or without supplemental oxygen the user will treat sleep disordered breathing. Additionally, the device can be used in the outpatient setting to treat chronic disorder. The device can be used in the inpatient setting to treat acute respiratory failure. Similarly, the device can be used in the diagnostic setting to determine the best settings to treat a respiratory disorder. 
         [0032]    The device may be designed to address the treatment for sleep disordered breathing; the more common known or treated being Obstructive Sleep Apnea Syndrome, acute respiratory failure or the like. Specifically the device may keep the upper airway (i.e., oral &amp; hypo-pharynx) open while asleep or awake and receive respiratory/ventilator assist. 
         [0033]    It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.