DEVICE AND METHOD FOR HELPING PREVENT SNORING AND SLEEP APNEA

A mouth appliance that includes an upper tray having an outer wall, an inner wall and an occlusal wall that cooperate to define an upper teeth space, a lower tray having an outer wall, an inner wall and an occlusal wall that cooperate to define a lower teeth space, a tongue retaining member, and an extension member extending between the inner wall of the upper tray and the tongue retaining member.

FIELD OF THE INVENTION

The present invention relates generally to a device for helping prevent snoring and sleep apnea.

BACKGROUND OF THE INVENTION

Snoring and obstructions of the airway during sleep are prevalent problems in the general population. When severe, obstructions of the airway during sleep can cause momentary cessation of breathing. Cessation of breathing lasting at least for 10 seconds is referred to as apnea. Hypopnea is an episode of obstruction of the airway where there is a considerable reduction in the amount of air, but not necessarily a total cessation of breathing.

Snoring may be a loud and vibratory noise produced by turbulent airflow caused by restriction of air passages through partially obstructed airways. The muscle tone of the body ordinarily relaxes during sleep. At the level of the throat, the human airway is composed of collapsible walls of soft tissue which can obstruct breathing during sleep. Snoring can result from the tongue falling backwards onto the soft palate and the pharynx. This is due to relaxation of the muscles that control the throat, back of the tongue, lower jaw, and neck.

Snoring and obstructions of the airway during sleep are associated with significant morbidity, and a higher risk of developing cardiovascular diseases, high blood pressure, and diabetes. Excessive daytime sleepiness resulting from snoring or apnea increases the risk of being involved in traffic accidents as well. Snoring can also interfere with marital harmony.

Some treatments involve lifestyle changes, such as avoiding alcohol or muscle relaxants, losing weight, and/or quitting smoking. Many people benefit from sleeping at a 30 degree elevation of the upper body or higher, as if in a recliner. Doing so, helps prevent the gravitational collapse of the airway. Lateral positions (sleeping on a side), as opposed to supine positions (sleeping on the back), are also recommended as a treatment for snoring and sleep apnea, largely because the gravitational component of the tongue falling back to obstruct the airway is less in the lateral position. There are also surgical procedures to remove and tighten tissue and widen the airway, but these tend to be very intrusive and can have serious risks and complications.

Continuous positive airway pressure (CPAP) is a standard treatment for obstructions of the airway that occur during sleep. Unfortunately, up to 83% of patients that are prescribed CPAP are non-adherent and use their CPAP less than four hours per night.

In spite of the different prior inventions for the control of snoring and sleep apnea, there still remains a need for additional improved methods and devices for reducing the burden of managing snoring and sleep apnea through minimally invasive approaches that provide long term results, that encourage patient compliance, and that minimize patient discomfort.

The floor of the mouth consists of muscles involved in keeping the airway open. The Genioglossus muscle is connected from behind the chin, and becomes the major muscle of the base of the tongue. The Geniohyoid muscle is connected from behind the chin and inserts into the hyoid bone which is a small bone under the mandible and anterior to the trachea airway. The Mylohyoid muscle runs from the mandible to the hyoid bone, forming the floor of the oral cavity of the mouth.

SUMMARY OF THE PREFERRED EMBODIMENTS

In accordance with a first aspect of the present invention there is provided a mouth appliance that includes an upper tray having an outer wall, an inner wall and an occlusal wall that cooperate to define an upper teeth space, a lower tray having an outer wall, an inner wall and an occlusal wall that cooperate to define a lower teeth space, a tongue retaining member, and an extension member extending between the inner wall of the upper tray and the tongue retaining member.

In a preferred embodiment, the tongue retaining member includes an upper wall, a lower wall and a front wall that cooperate to define a tongue retaining member interior. Preferably, the front wall is curved and defines a tip, the extension member defines first and second ends, and the first end of the extension member is attached to the inner wall of the upper tray and wherein the second end is connected to the tip of the front wall. In another embodiment it can be a flat front wall or surface instead of including a tip. In a preferred embodiment, the inner wall of the upper tray includes an upper surface, and the extension member extends from the upper surface. Preferably, the inner wall of the upper tray includes an inner surface, the extension member includes an upper surface, and the inner surface of the inner wall of the upper tray and the upper surface of the extension member form a continuous surface. In a preferred embodiment, the extension member is curved. However, in another embodiment, the extension member can be straight and can extend from a location on the outer surface of the inner wall.

In a preferred embodiment, the lower wall of the tongue retaining member includes a frenum recess defined therein. Preferably, the tongue retaining member includes a rear surface, and the frenum recess is defined in the lower wall and the rear surface. In a preferred embodiment, at least a portion of the tongue retaining member is positioned higher than the upper tray.

In accordance with another aspect of the present invention there is provided a method of helping prevent snoring that includes the steps of obtaining a mouth appliance that includes an upper tray having an outer wall, an inner wall and an occlusal wall that cooperate to define an upper teeth space, a lower tray having an outer wall, an inner wall and an occlusal wall that cooperate to define a lower teeth space, a tongue retaining member, wherein the tongue retaining member includes an upper wall, a lower wall and a front wall that cooperate to define a tongue retaining member interior, and an extension member extending between the inner wall of the upper tray and the tongue retaining member, and positioning the mouth appliance in an oral cavity that includes upper teeth, lower teeth, a palate and a tongue, such that the upper teeth are received in the upper teeth space and the lower teeth are positioned in the lower teeth space. The method further includes inserting the tongue into the tongue retaining member interior, such that an upper surface of the tongue that is exterior to the tongue retaining member interior is positioned against the palate.

The present invention includes a method of a user wearing an oral appliance where the mandible is advanced forward keeping the airway open by pulling the base of the tongue and the hyoid bone forward.

The Palatoglossus muscle runs from the aponeurosis of the soft palate and inserts into the side of the tongue (seeFIG. 2). When the user wears the oral appliance which advances the mandible forward, the Palatoglossus muscles bilaterally are stretched placing tension on the soft palate preventing obstructions of the airway to occur at the upper pharyngeal area of the soft palate. This also prevents the vibration of the soft palate tissues involved in snoring.

The present invention also includes a method whereby the dorsum of the tongue is retained forward, pulling the base of the tongue forward, and preventing the gravitational drifting back of the base of the tongue which would impinge and obstruct the airway. This occurs especially when a person lies supine (on his or her back). The dorsum of the user's tongue also being retained upward against the hard palate stops airflow through the mouth and promotes nasal breathing. Mouth breathing has been documented in the scientific literature to cause obstructions of the airway. Mouth opening and oral breathing during sleep are associated with narrowing of the pharyngeal lumen and decreases in retroglossal diameter, which increase upper airway collapsibility and may lead to airway obstruction.

The present invention is an oral appliance for the prevention of snoring and sleep apnea. This oral appliance opens the airway by bringing the mandible forward and by also retaining the dorsum of the tongue forward and upward against the upper hard palate. In a preferred embodiment, the appliance is a one-piece device molded from a flexible polymer, which has an upper maxillary tray and a lower mandibular tray, as well as a tongue retaining portion attached to the upper maxillary tray. In another embodiment, the appliance can be multiple or a plurality of pieces and can be made of other materials.

In a preferred embodiment, in use, the oral appliance advances the mandible and hyoid bone forward and thereby opens up the posterior pharyngeal airway; and at the same time the oral appliance retains the user's dorsum of the tongue forward and upward against the user's hard palate which elevates the base of the tongue musculature further opening the airway; thus eliminating snoring and obstructions of the airway during sleep.

In a preferred embodiment, the device is an oral appliance that alters the position of the user's mandible by advancing the position of the mandible forward relative to the position of the maxilla, thereby advancing the hyoid bone in a forward direction which results in the opening of the airway. The advancement of the mandible in a forward direction also stretches the palatoglossus muscles whose origin is the soft palate in the back of the mouth. By tensing the soft palate it does not allow an obstruction of the airway to occur at the upper pharyngeal airway. In a preferred embodiment, the oral appliance also retains the dorsum of the tongue forward and upward against the user's upper hard palate raising the base of the tongue forward. Preferably, the device does not allow the tongue to drift back, thereby preventing the posterior portion of the base of the tongue from closing the airway. The dorsum of the tongue being placed up against the hard palate also stops mouth breathing and promotes nasal breathing. Mouth breathing has been documented in the scientific literature to cause obstructions of the airway.

In a preferred embodiment, the present invention embodies a mouthpiece device that includes an upper maxillary tray and a lower mandibular tray. The upper tray includes an inner wall and an outer wall, the lower tray includes an inner wall and an outer wall, and the device (the upper and lower trays) are hinged together bilaterally. In a preferred embodiment, the device further includes a tongue retaining portion on the inner wall of the upper tray.

In a preferred embodiment, the device serves to reduce the effects of snoring or sleep apnea by both bringing the mandible and hyoid bone forward and at the same time the device retains the user's dorsum of the tongue anteriorly and upward against the hard palate. In a preferred embodiment, the device serves to prevent the user from breathing through the mouth by both allowing the upper and lower trays of the device to close completely together, and also by placing and retaining the dorsum of the user's tongue upward against the hard palate.

In a preferred embodiment, the upper tray and the lower tray have holes (preferably circular, but can be non-circular) defined therethrough to allow for the user's saliva to escape. Preferably, the upper tray and the lower tray allow the user to be able to move his or her mandible from side to side. In a preferred embodiment, the inner wall of the lower tray includes a longer portion, such that in use the longer portion extends into a user's lingual vestibule to provide advancement of the user's mandible and by not placing pressure on the user's lower mandibular incisor teeth. Preferably, the upper tray and the lower tray extend at least to a user's upper and lower molar teeth when the device is fully inserted. Preferably, the device of the present invention reduces the effects of bruxism.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Appearances of the phrase “in one embodiment” in various places in the specification do not necessarily refer to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments.

It will be appreciated that terms such as “front,” “back,” “top,” “bottom,” “side,” “short,” “long,” “up,” “down,” and “below” used herein are merely for ease of description and refer to the orientation of the components as shown in the figures. It should be understood that any orientation of the components described herein is within the scope of the present invention.

Described herein is a mouth appliance10and system for helping prevent snoring and sleep apnea. As shown inFIGS. 1-3, the mouth appliance10generally includes an upper tray12, a lower tray14, an extension member15and a tongue retaining member20. mber.

FIG. 1is a perspective view of the preferred embodiment of the invention in an open position, not in the user's mouth. As can be seen, the mouth appliance10folds at hinge16on the right, and at the hinge16on the left. The upper maxillary tray12and lower mandibular tray14are both u-shaped, joined together by the hinges16bilaterally. The length of the upper tray12and the lower tray14are preferably formed so that the trays12and14of the device extend back at least to the user's upper and lower molar teeth bilaterally when fully inserted. This allows for an ample amount of space for the teeth to be retained in the upper12and lower14trays, but does not extend too far into the mouth so as to create discomfort or to promote gagging. The bilateral hinges16permit the device to flex and bend as a hinge. The bilateral hinges16also allow for lateral movement of the bottom surface of the upper occlusal wall11of the upper tray12to slide on the top surface of the lower occlusal wall13of the lower tray14from side to side. The saliva holes18that extend through the upper and lower occlusal walls11and13allow for saliva to escape when the device10is in the mouth. In a preferred embodiment, the hinge can be omitted and the upper and lower occlusal walls can be connected to one another (or be a single occlusal wall that includes upper and lower surfaces). Both of the upper and lower walls including an occlusal wall can be a single or combined occlusal wall in an embodiment where the hinges are omitted. In this embodiment, the upper and lower trays can be a U-shape, as shown in the drawings, or can be shaped to only receive the front or anterior teeth. In other words, the upper and lower trays can be a single piece and are not hingedly connected.

As shown inFIGS. 1-4, in a preferred embodiment, the upper tray12includes an outer wall32, an inner wall30and upper occlusal wall11that cooperate to define an upper teeth space21. The lower tray14includes an outer wall36, an inner wall34and lower occlusal wall13that cooperate to define a lower teeth space23. Preferably, the extension member15extends between the inner wall30of the upper tray and the tongue retaining member20, which extends upward toward the hard palate allowing the tongue to be retained in an anterior and upward position against the hard palate (seeFIG. 4). In another embodiment, the tongue retaining member20can be directly connected to the top of the inner wall30of the upper tray12.FIG. 1is a perspective view of the device, showing the upper tray12and the lower tray14in an open position, with the saliva holes18in the upper occlusal wall11of the upper tray12and on lower occlusal wall13of the lower tray14.

As shown inFIG. 2, the tongue retaining member20includes an upper wall40, a lower wall42and a front wall44that cooperate to define a tongue retaining member interior22. The tongue is placed in the tongue retaining member interior22opening of the tongue retaining portion20of the device10. In a preferred embodiment, the front wall44is curved and defines a tip. Preferably, the extension member15defines first and second ends and the first end of the extension member15is attached to the inner wall30of the upper tray12and the second end is connected to the tip of the front wall44. In a preferred embodiment, as is best shown inFIG. 2, the inner wall30of the upper tray12includes an upper surface30a, and the extension member15extends from the upper surface30a. The inner wall30of the upper tray12includes an inner surface30b, the extension member includes an upper surface15a, and the inner surface30bof the inner wall30of the upper tray12and the upper surface15aof the extension member15form a continuous surface. In another embodiment, the extension member can extend from the outer surface of the inner wall. As shown inFIG. 4A, in another embodiment, the extension member15can extend to a location at the top of the front wall44or blend into the upper wall40of the tongue retaining member20.

As shown inFIG. 4, in a preferred embodiment, the extension member15is curved and such that at least a portion of the tongue retaining member20is positioned horizontally above the upper tray12. As will be appreciated by a person of ordinary skill in the art, the palate curves upwardly. The curved and projecting upwardly extension member15allows the tongue retaining member20to be positioned near or against the palate.

Anatomically, the lower portion of the tongue has an attached tissue connecting the tongue to the bottom of the floor of the mouth called a frenum. In a preferred embodiment, the lower wall42of the tongue retaining member includes a frenum recess frenum cleft or frenum recess24defined therein. The tongue retaining member20includes a rear surface20a. Preferably, the frenum recess24is defined in the lower wall42and the rear surface20a. The frenum recess allows the frenum to extend therethrough so that it is not irritated when the tongue is held in the tongue retaining member20. The frenum recess24can be U or V-shaped.

In a preferred embodiment, the inner wall34of the lower mandibular tray14includes a longer lingual portion that serves to extend into the user's lingual vestibule below the user's lower incisor teeth to advance the mandible forward by pressure placed on the user's lingual vestibule portion of the mandible instead of pressure placed directly on the user's teeth.

In a preferred embodiment, the lower tray14is extends forward of the upper tray12. This is to bring the user's mandible forward to open the airway. The tongue retaining portion20is preferably extends toward the user's palate as it is connected to the extension portion15or the inner wall30of the upper tray12. The hinge16is closed position when the upper maxillary tray12is closed onto the lower mandibular tray14, as shown inFIG. 2.

Overall mouth appliance10readily bends in half at bilateral hinges16. In use, the mouth appliance10is inserted into the user's mouth or oral cavity, with the user's maxillary teeth pressing into upper maxillary tray12and the user's mandibular teeth pressing into lower mandibular tray14. The user's maxillary teeth are cradled by the inner wall of upper maxillary tray30and the outer wall of upper maxillary tray32. The user's mandibular teeth are cradled by the inner wall34of lower mandibular tray14, and the outer wall36of the lower mandibular tray14. The lower tray14protruding further than the upper tray12maintains the mandible in a forward position. In addition, the contact of the longer lingual inner wall of tray14to the lingual surface of the lower lingual vestibule maintains the mandible in a forward position relative to the maxilla, whereby the airway passage in the pharyngeal airway is kept open thus eliminating snoring and/or obstructions of the airway. At the same time, the user's tongue is held by a vacuum surface tension of the tongue in the tongue retaining portion20of the mouth appliance10. In this way the tongue is held anteriorly and upward against the palate, as shown inFIG. 4. This blocks any mouth breathing and also retains the tongue from falling back and closing the pharyngeal airway, thus also eliminating snoring and/or obstructions of the airway.

The position of the two closed trays12and14relative to each other, holds the mandible forward and still allows side to side motion between the upper and lower trays12and14, which makes it more comfortable for the user. It also allows the user to have his or her mouth closed to prevent any mouth breathing which can cause obstructions of the airway to occur.

In the preferred embodiment, the mouth appliance is molded from an appropriate suitable flexible material, whether in the form of synthetic polymers, silicone, or even natural rubber.

While the overall mouth appliance serves primarily for the purpose of mandibular advancement, with the associated sleep-related benefits, the device also serves to reduce problems associated with bruxism, or the grinding of the teeth. The mechanism for this is readily apparent, as the upper and lower trays prevent the maxillary and mandibular teeth from making direct contact.

The above described elements combine to create a mandibular advancement and a tongue retaining device that does not require custom fitting and is easily used off-the-shelf. Although the above specification and related drawings describe a specific embodiment of the invention, this should not be interpreted as limiting the scope of the invention to these particular elements. The interpretation of the scope of the invention should be determined by the claims and their legal equivalents.

Embodiments are envisioned where any of the aspects, features, component or steps herein may be omitted and/or are option. Furthermore, where appropriate any of these optional aspects, features, component or steps discussed herein in relation to one aspect of the invention may be applied to another aspect of the invention.

The above-detailed description of embodiments of the disclosure is not intended to be exhaustive or to limit the teachings to the precise form disclosed above. While specific embodiments of and examples for the disclosure are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. Further, any specific numbers noted herein are only examples: alternative implementations may employ differing values, measurements or ranges. It will be appreciated that any dimensions given herein are only exemplary and that none of the dimensions or descriptions are limiting on the present invention.