Abstract:
A device for treating sleep apnea, the device comprising a tongue attachment member and a maxilla attachment subassembly. The tongue attachment member is fabricated having a sheath interlock member extending upward from a dorsal side of a sheath. The sheath is shaped to conform to a surface of an individual&#39;s tongue. A tongue receiving cavity is formed within the sheath, the cavity comprising an opening provided at a proximal end for receiving the individual&#39;s tongue. The sheath is referenced having a dorsal side and a ventral side. A sheath interlock member extends outward from the dorsal side. The maxilla tray is shaped to conform to and removably engage with an individual&#39;s upper dental arch. A tray interlock member extends from an interlock side of the maxilla tray and is positioned to interlock with the sheath interlock member, whereby the system extends an individual&#39;s tongue forward to treat sleep apnea.

Description:
FIELD OF THE INVENTION 
     The present disclosure relates to an oral medical apparatus used in the prevention of snoring and sleep apnea. More particularly, it concerns improvements related to comfort and efficiency for its user. Accordingly, this oral medical apparatus improves upon apparatuses that are of similar scope and utility. 
     BACKGROUND OF THE INVENTION 
     The present invention provides an oral medical apparatus used in the prevention of snoring and sleep apnea. Snoring is the vibration of respiratory structures and the resulting sound due to obstructed air movement when a human breathes during sleep. Generally, the uvula and soft palate are the anatomical structures that cause the sound of snoring if a human&#39;s tongue drops to the back of their mouth during sleep. 
     Sleep apnea is a sleep disorder characterized by having one or more pauses in breathing, or shallow breaths during sleep, and is typically accompanied by snoring. Each pause or cessation is generally referred to as an apnea, and can last from a few seconds to minutes. Additionally, each apnea may occur from five to thirty or more times per hour of sleep. Although most humans do experience some level of sleep apnea during their lifetime, a relatively smaller percentage (approximately 20%) of humans, suffer with chronic, severe sleep apnea. A combination of factors cause sleep apnea or snoring. One factor is the relaxation of muscle tone that results from sleep. Another factor is the vibration of soft, collapsible tissue surrounding the human airway, which causes snoring. 
     There are several snoring control devices known in the art. These devices provide for reception of the tongue in a hollow tongue-retained holder. One problem presented by these devices, however, is the inadequate fit between the tongue-retained holder and the user&#39;s tongue. In particular, the device determines the position of the tongue. Consequently, a relatively long tongue is not properly or comfortably accommodated within the socket. Different sized devices or custom fabricated devices can be provided to help overcome this shortcoming, wherein the variety and custom fit devices are provided at a higher cost. 
     Another known device provides a tongue sleeve configured for reception and retention of the outer extent of the user&#39;s tongue, and includes a shield shaped to be received and retained outside of the user&#39;s lip, as well as a component that allows the user to attach and adjust the shield to the tongue sleeve. This component permits for selective adjustment of the shield&#39;s position relative to the tongue, reducing snoring and airway obstruction. 
     Another device known as the aveoTSD, provides suction between the device and the user&#39;s tongue. This suction prevents the tongue from moving toward the back of the mouth, thereby, keeping the airway open during sleep to prevent snoring. The device is known to slip and some wearer&#39;s have felt that it is uncomfortable. 
     Unfortunately, with all of the attempted improvements that have been made in sleep apnea prevention devices, there remains a need for a device that is more comfortable to wear and provides more effective results. 
     SUMMARY OF THE INVENTION 
     The present disclosure is generally directed to a sleep apnea control device, the device comprising: 
     a tongue attachment subassembly comprising:
         a sheath shaped to conform to a surface of an individual&#39;s tongue, the sheath having a tongue receiving cavity defining an opening for receiving the individual&#39;s tongue provided at a proximal end thereof, the sheath having an orientation defined by a dorsal side and a ventral side, and   a sheath interlock member extending outward from the dorsal side of the sheath; and       

     a maxilla attachment subassembly comprising:
         a maxilla tray shaped to conform to and removably engage with an individual&#39;s upper dental arch, the maxilla tray defined having an engagement side and an interlock side, and   a tray interlock member extending from the interlock side of the maxilla tray and positioned to interlock with the sheath interlock member, which, when interlocked, extends an individual&#39;s tongue during use.       

     In one aspect, the sheath interlock member is fabricated of a rigid material and the tongue attachment subassembly is fabricated of a pliant material. 
     In another aspect, the device further includes an air extraction system. An embodiment of the air extraction assembly is provided, which comprises an air extraction valve integrated into the tongue attachment subassembly, wherein the valve is in fluid communication with the tongue receiving cavity. The air extraction device may include an air extraction pipette in fluid communication with an air extraction bulb, where the air extraction pipette is in fluid communication with the air extraction valve to remove air from within the tongue receiving cavity. The air extraction device can be retained or integrated with the air extraction valve or removeable therefrom. 
     In another aspect, the sheath interlock member further comprises a sheath interlock ridge, and the tray interlock member further comprises a tray interlock ridge, the ridge having an interlock interface to removably engage the sheath interlock ridge and the tray interlock ridge. 
     In another aspect, the interlock interface is fabricated having a series of teeth and teeth-receiving receptacles. 
     In another aspect, the interlock teeth are disposed at an acute angle. 
     In another aspect, the tongue attachment subassembly further includes a tongue base clearance defined by a U-shaped recession in the ventral side, which extends inward from an opening of the tongue receiving cavity opening. 
     In another aspect, the tongue attachment subassembly is fabricated having a bladder formed within the main body walls, wherein the air extraction valve is provided in fluid communication with the bladder. The user extracts air from the bladder, securing the tongue attachment subassembly to the individual&#39;s tongue. 
     These and other advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will now be described, by way of example, with reference to the accompanying drawings, in which: 
         FIG. 1  presents a perspective view of a dorsal side of a tongue attachment member of a sleep apnea control device; 
         FIG. 2  presents a sectioned view of the tongue attachment member taken along section  2 - 2  of  FIG. 1 ; 
         FIG. 3  presents a perspective view of a ventral side of the tongue attachment member; 
         FIG. 4  presents an enlarged sectioned view of a distal end of the tongue attachment member, detailing an air removal system; 
         FIG. 5  presents a perspective view of the dorsal side of the tongue attachment member and the air removal system; 
         FIG. 6  presents a perspective view of a sheath interlock member; 
         FIG. 7  presents an anterior elevation view of the tongue attachment member; 
         FIG. 8  presents a side sectioned view of the tongue attachment member taken along a longitudinal centerline, wherein the tongue attachment member is secured to an individual&#39;s tongue; 
         FIG. 9  presents an end elevation view of the sheath interlock member; 
         FIG. 10  presents a bottom side plan view of a maxilla attachment member of the apnea control device; 
         FIG. 11  presents a side elevation view of the apnea control device demonstrating proper positioning within an individual&#39;s mouth; 
         FIG. 12  presents a side elevation view of the tray interlock member engaged with the sheath interlock member; 
         FIG. 13  presents an exemplary flow diagram illustrating a method of use of the sleep apnea control device; and 
         FIG. 14  presents a side sectioned view of an alternate tongue attachment member taken along a longitudinal centerline, wherein the tongue attachment member is secured to an individual&#39;s tongue. 
     
    
    
     Like reference numerals refer to like parts throughout the various views of the drawings. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. For purposes of description herein, the terms “upper”, “lower”, “left”, “rear”, “right”, “front”, “vertical”, “horizontal”, and derivatives thereof shall relate to the invention as oriented in  FIG. 1 . Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise. 
     A sleep apnea control device is provided for the prevention of snoring and sleep apnea. The sleep apnea control device includes a tongue attachment subassembly  100  and a maxilla attachment subassembly  200 , as illustrated in  FIG. 11 . 
     The tongue attachment subassembly  100  is detailed in  FIGS. 1 through 9 . The maxilla attachment subassembly  200  is detailed in  FIG. 10 . The tongue attachment subassembly  100  includes a sheath  110 , wherein the sheath  110  is defined having a tongue receiving cavity  112  for insertion of an individual&#39;s tongue  300 . The tongue attachment subassembly  100  can be defined having a dorsal side  114  and a ventral side  116 . The sheath  110  can also be defined having an exterior surface  120  and a tongue engagement surface  122 . An air extraction valve  140  is integrated into the sheath  110  at a sheath distal end  118 . The illustrated air extraction valve  140  is only exemplary and it is understood that it can include any unidirectional valve known by those skilled in the art. The device may be fabricated from any of a plethora of known, non-toxic materials. The sheath  110  is fabricated of a pliant material, such as latex, silicone, rubber, and the like. The sheath  110  can be molded, thermally formed, or constructed using similarly known fabrication techniques. 
     A sheath interlock member  130  is integrated into a dorsal side  114  portion of the sheath  110 . Details of the sheath interlock member  130  are presented in  FIG. 6 . The sheath interlock member  130  includes an interlock ridge  132  having a series of interlock teeth  134  and interlock teeth-receiving receptacle  136  extending outward from the tongue engagement surface  122  of the dorsal side  114 . The preferred design orients the interlock teeth  134  and interlock teeth-receiving receptacle  136  such that a base of each interlock teeth  134  is slightly forward of its top of the respective interlock teeth  134 . The sheath interlock member  130  can be integrated into the sheath  110  during the fabrication of the tongue attachment subassembly  100  using the same material, using a different material, or joined in a post fabrication assembly step. The sheath interlock member  130  can include an optional interlock base portion  138  for attachment to the sheath  110 . The interlock base portion  138  can be formed having an arched shape with a downward apex, wherein the apex applies additional pressure to the individual&#39;s tongue  300 . The interlock ridge  132  is inserted through an aperture formed in the dorsal side  114  and attached using any adequate attachment means. An exemplary attachment bonds the interlock base portion  138  to the exterior surface  120  using a bonding media, as illustrated in  FIG. 7 . The sheath interlock member  130  is preferably constructed from a rigid material, such as plastic, hard rubber, nylon, and the like. The sheath interlock member  130  is preferably fabricated using a molding process, but it is recognized that the sheath interlock member  130  can be fabricated using any reasonable process respective to the material selection. The bonding can be provided using any bonding medium, using a heat staking process, using an ultrasonic welding process, and the like. 
     The tongue attachment subassembly  100  is placed over and secured to an individual&#39;s tongue  300  as illustrated in a  FIGS. 8 and 11 . A tongue base clearance  117  can be formed within the ventral side  116  of the sheath  110 , providing a clearance for a tongue base  306 . The tongue base clearance  117  is a recess in the ventral side  116  of the sheath  110 , extending inward from an opening for the tongue receiving cavity  112 . A securing seal is created by evacuating air from a gap  304  formed between a tongue surface  302  of the individual&#39;s tongue  300  and the tongue engagement surface  122 . As the sheath  110  is placed upon the individual&#39;s tongue  300 , air within the tongue receiving cavity  112  is displaced and a seal is created between the tongue surface  302  and a rear portion of sheath  110 . A majority of the remaining air is removed using an air removal system. The air removal system includes an air extraction valve  140  and an air extraction device  150 . The air extraction device  150  engages with the air extraction valve  140  to extract air from the gap  304 . Details of the air removal system are illustrated in  FIG. 4 . The air extraction device  150  includes an air extraction bulb  152  in fluid communication with an air extraction pipette  154 . In the exemplary embodiment, the air extraction pipette  154  is inserted through a unidirectional valve orifice  146  separating a unidirectional valve flap  142  from a unidirectional valve seal  144 . This creates an airflow passage between the gap  304  and the air extraction bulb  152 . The user would preferably squeeze the air extraction bulb  152  to discharge air from within the air extraction bulb  152  prior to insertion of the air extraction pipette  154  through the unidirectional valve orifice  146 . Once inserted, the user would release the pressure from the air extraction bulb  152 , thus causing the air extraction bulb  152  to extract air from the gap  304 . The user then removes the air extraction device  150  from the air extraction valve  140 . The unidirectional valve flap  142  naturally retracts to a sealed configuration, seating against the unidirectional valve seal  144 . The removal of air from the gap  304  creates a vacuum, which secures the sheath  110  onto the individual&#39;s tongue  300 . It is understood that although the illustrations present a removable air extraction device  150 , the air extraction device  150  can alternately be integrated into the air extraction valve  140 . The air extraction device  150  can be used to aid in the return of air into the air extracted region to aid in removal of the tongue attachment subassembly  100  from the individual&#39;s tongue  300 . 
     The maxilla attachment subassembly  200  is formed of a resilient material and shaped to be removably attached to a maxilla (upper jaw)  320 . The maxilla attachment subassembly  200  includes a maxilla tray  210 , which is formed in a “U-shape”, contouring to the maxilla (upper jaw)  320 . The maxilla tray  210  is defined having a maxilla tray&#39;s attachment side  220  and a maxilla tray&#39;s interlock side  222 . The maxilla tray&#39;s interlock side  222  includes a recession formed into the maxilla tray  210  for receiving individual&#39;s teeth. The maxilla attachment subassembly  200  is fabricated having a tray interlock member  230  disposed upon the maxilla tray&#39;s interlock side  222  of the maxilla tray  210 . The maxilla tray  210  is shaped to be removably attached to the maxilla (upper jaw)  320 . 
     The maxilla tray  210  is secured by its shape and can optionally include one or more features to aid in the engagement with the individual&#39;s teeth. The maxilla tray  210  can be formed to mate with the maxilla (upper jaw)  320  by placing the maxilla attachment subassembly  200  into hot water, inserting the maxilla attachment subassembly  200  into the individual&#39;s mouth, and placing with finger pressure into an interior recession. This will shape the interior portion of the maxilla tray  210  to mate with the maxilla (upper jaw)  320 . Another technique to form the maxilla tray  210  is to have a custom maxilla tray  210  fabricated by the individual&#39;s dentist or other oral health care professional. This technique allows the maxilla tray  210  to be custom fit for the user. The custom version of the maxilla attachment subassembly  200  would be fabricated in a manner similar to that for teeth whitening trays from their dentist. A tray interlock member  230  is positioned onto the maxilla tray  210  to interlock with the sheath interlock member  130  as illustrated in  FIGS. 11 and 12 . An interlock is formed by an engagement between the interlock teeth  134  of the sheath interlock member  130  and the interlock tooth receptacle  236  of the tray interlock member  230 , and similarly with the engagement between the interlock tooth  234  of the tray interlock member  230  and the interlock teeth-receiving receptacle  136  of the sheath interlock member  130 . The interlock between the sheath interlock member  130  and the tray interlock member  230  draws and maintains the individual&#39;s tongue  300  forward, to an extended tongue  310 . The teeth engage by the angled relation of the between the interlock tooth  234  and the interlock teeth-receiving receptacle  136 . The extended tongue  310  is positioned, resting upon teeth and/or gums of an individual&#39;s mandible (lower jaw)  322 . The extended tongue  310  and the fixed position of the jaw will reduce or eliminate snoring and sleep apnea. 
     The sleep apnea control device can be removed from the individual&#39;s mouth by opening the individual&#39;s mouth, which separates the engaged sheath interlock member  130  and tray interlock member  230 , removing the maxilla attachment subassembly  200 , then releasing the vacuum holding the tongue attachment subassembly  100  and removing the tongue attachment subassembly  100  from the individual&#39;s tongue  300 . The vacuum can be removed by squeezing the two sides of the tongue attachment subassembly  100  together to separate the rear edge from the individual&#39;s tongue  300  or by inserting the air extraction pipette  154  into the air extraction valve  140 , which separates the unidirectional valve flap  142  from the unidirectional valve seal  144 , and squeezing the air extraction bulb  152  to inject air into the tongue receiving cavity  112 . Upon combining the fixed, forward location  310  of a user&#39;s tongue  300  with adequate, uniform suction between the user&#39;s tongue  300  and the sheath  310 , a comfortable and efficient oral medical apparatus used in the prevention of snoring and sleep apnea is realized. 
     Although the exemplary embodiments include the air extraction valve  140 , it is understood that the tongue attachment subassembly  100  can be fabricated excluding the air extraction valve  140 . The user would manually remove the air within the tongue surface  302  by sucking the air therefrom. 
     An exemplary sleep apnea control method flow diagram  200  is presented in  FIG. 13 . The method initiates with a step  402  of the individual obtaining the sleep apnea control device, the device comprising the tongue attachment member  100  and the maxilla attachment subassembly  200 . The user places their tongue  300  into the tongue receiving cavity  112  in accordance with a tongue attachment subassembly installation step  404 . The user removes a majority of the residual air remaining between the tongue engagement surface  122  of the tongue receiving cavity  112  and the individual&#39;s tongue  300  in accordance with an air removal step  406 . The maxilla attachment subassembly  200  is positioned, placing the maxilla tray&#39;s attachment side  220  against the individual&#39;s maxilla (upper jaw)  320  in accordance with a maxilla attachment subassembly installation step  408 . The process continues with the user extending their tongue  300  (tongue extending step  410 ) and engaging the sheath interlock member  130  and the tray interlock member  230  together, referred to as an interlock engagement step  412 . At this point, the device is ready for use and the individual can enjoy a night&#39;s sleep  414 . Upon completion of use, the individual disengages the interlock provided between the sheath interlock member  130  and the tray interlock member  230 . The user opens their mouth and removes the vacuum provided between the tongue receiving cavity  112  and the individual&#39;s tongue  300  in accordance with a vacuum removal step  416 . Once released, the user removes the tongue attachment subassembly  100  from their tongue  300  per a tongue attachment subassembly removal step  418 . The use is concluded with the removal of the maxilla attachment subassembly  200  from the individual&#39;s maxilla (upper jaw)  320  in accordance with a maxilla attachment subassembly removal step  420 . The user then stores the sleep apnea control device for future use. 
     An alternate embodiment of the tongue attachment device  100  is presented as a tongue attachment device  400  illustrated in  FIG. 14 . Like features of tongue attachment device  400  and tongue attachment device  100  are numbered the same except preceded by the numeral ‘4’. The tongue attachment device  400  utilises an internally provided suction compared to the tongue attachment device  100 , which utilises an externally applied suction. The tongue attachment device  400  is fabricated having a bladder air chamber  464  formed therein. The bladder air chamber  464  is defined by a bladder interior wall  462  formed on the tongue-contacting portion of the tongue attachment device  400  and a bladder exterior wall  460  formed on the external portion of the tongue attachment device  400 . The user would remove the air from within the bladder air chamber  464  drawing and securing the tongue attachment device  400  onto the individual&#39;s tongue  300 . The tongue attachment device  400  would be shaped to include a tongue base clearance  117 . 
     Since many modifications, variations, and changes in detail can be made to the described preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalence.