Abstract:
Bruxism, which is a human medical condition characterized by clenching of the jaw and/or grinding of teeth, leads to conditions such as severe tooth wear and Temporomandibular Joint (TMJ) Disorder. Described herein is a biofeedback device that utilizes the human physiological reflex to open the mouth when the nasal airway is obstructed. The device and method blocks the nasal airway while clenching, but allows nasal respiration while not clenching. Clenching of the jaw and breathing through the mouth cannot happen simultaneously while unconscious.

Description:
PRIORITY CLAIM 
       [0001]    The present nonprovisional patent application claims the benefit of and priority to, under 35 USC §119(e), U.S. Provisional Patent Application No. 62/083,073, filed Nov. 21, 2014, entitled “DEVICE AND METHOD FOR THE TREATMENT OF BRUXISM BY UTILIZING THE PHYSIOLOGICAL REFLEX WHICH CAUSES THE HUMAN BODY TO OPEN THE MOUTH WHEN THE NASAL AIRWAY IS BLOCKED”, the entirety of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Bruxism is a detrimental human medical condition characterized by clenching of the jaw and/or grinding of teeth. Bruxism leads to conditions such as severe tooth wear and Temporomandibular Joint (TMJ) Disorder. TMJ is characterized by painful inflammation of the jaw joint and sinuses as well as headaches and neck pain. It is estimated that 33% of the population has bruxism to some extent and 5-12% of the population suffers from severe TMJ symptoms. Bruxism manifests itself nocturnally, while the user is unconscious and unable to control the clenching and grinding behavior. This is known as sleep bruxism. 
         [0003]    There currently are no completely effective treatments for sleep bruxism. The treatments that have demonstrated some effectiveness, such as biofeedback devices, rely on waking the user to cease the clenching behavior. This is accomplished with negative feedback (loud noise or foul tasting fluid) during the clenching behavior. These feedback methods are limited in their effectiveness because bruxism typically occurs during, or when coming out of, a very deep sleep when the user is slow to wake. These methods are also unpopular because they can provide feedback before the user is fully asleep (given an inadvertent bite-down). Also, they have been known to disturb the user&#39;s bed partner without waking the user. 
       SUMMARY OF THE INVENTION 
       [0004]    While researching improved treatments for sleep bruxism, it was observed that sufferers of sleep bruxism have reported relief from clenching when they are suffering from the common cold. The blockage of the nasal airway, as caused by the common cold, causes the user to breathe through his/her mouth only. The relief from sleep bruxism is because humans cannot clench their teeth/jaw and breathe through his/her mouth simultaneously while unconscious. 
         [0005]    The invention is based on the physiological reflex that causes the human body to open the mouth when the nasal airway is blocked. The device blocks the nasal airway while clenching, but also allows nasal respiration while not clenching. The invention consists of a clench sensor and a nasal airway obstructor. When the clench pressure is detected, the nasal airway is blocked until the user stops clenching. The clenching, unclenching, and resumed nasal respiration sequence has been demonstrated to occur without waking the user. It has been verified that blockage of the nasal airway (airway inclusion) while unconscious is not normally dangerous. People, on average, have 5-10 airway inclusions per hour naturally while asleep. 
         [0006]    In various example embodiments, the invention, which obstructs the user&#39;s nasal airway upon detecting the clenching behavior, has two primary components including a clench or pressure sensor and a nasal airway obstructor. The clench sensor can be embedded in a custom fit mouthpiece, or rely on external orofacial indications caused by the clenching behavior. The sensor can communicate the clenching behavior to the nasal airway obstructor electrically, electromagnetically, mechanically, via fluid power transmission, or other similar mechanisms. The nasal airway obstructor can be an airway valve mounted within the air passage of a nasal manifold (pillow), hood, or mask type device, or it can be a device that physically plugs the user&#39;s nose by collapsing the nostrils or plugging the nostrils with any manner of stopper devices. 
         [0007]    The device may include a one-piece system or a two-piece system. With the one-piece system, the mouthpiece and associated clench sensor and nasal airway obstructor apparatus are connected via a high strength strut. The entire apparatus is anchored via upper teeth to the hard palate. The two-piece system detects the clench behavior with the clench sensor, and obstructs the nasal airway with a separate nasal airway obstructor. The two separate devices can communicate electrically, electromagnetically, mechanically, or via fluid power transmission. The two components of the two-piece system may be connected via a flexible conduit. 
         [0008]    In use, the device functions by first sensing a bite or clenching action with a clench sensor, which triggers a nasal airway obstructing device. Upon blockage of the nasal airway, the human body instinctively reacts by opening the mouth (unclenching the jaw) to allow oral respiration. Upon unclenching of the jaw, the device re-opens the nasal airway to allow nasal respiration. 
         [0009]    In an example embodiment, a device for treating bruxism includes a mouthpiece and a nasal airway obstruction member. The mouthpiece includes a sensor for sensing a mechanical or clenching pressure, and is configured to emit a signal upon reaching a pressure threshold. The nasal airway obstruction member is operatively connected to the mouthpiece and is capable of obstructing nasal respiration upon receiving the signal from the sensor. 
         [0010]    In an alternative embodiment, the device may include a nasal manifold, a hood, a mask, a physical plug, or a combination thereof. A nasal hood assembly may include a cup shaped hood and a strap coupled to the hood to maintain an airtight seal around a user&#39;s nasal airway. 
         [0011]    In yet another embodiment, the mouthpiece and nasal airway obstruction member are connected via a strut. Alternatively, the connection between the mouthpiece and the nasal airway obstruction member is established electrically, electromagnetically, mechanically, or via fluid or hydraulic transmission. Still further, the clench sensor and nasal airway obstruction member may communicate utilizing mechanical or electrical feedback from an external musculoskeletal structure of a user&#39;s orofacial region. In yet another embodiment, the pressure sensor of the device may be an electrical switch, a strain gauge, a piezoelectric crystal, a fluidic device, or a combination thereof. 
         [0012]    In still yet another embodiment, the nasal airway obstruction member is actuated when the pressure sensor detects clenching by the user, which causes the user to open his/her mouth to allow oral respiration. The nasal airway obstruction member may include a horizontal bar member with a nasal plunger located at each distal end of the bar member, and each nasal plunger is located adjacent to a nasal airway of the user. The nasal plunger may project towards and obstruct the nasal airway upon receiving a signal from the pressure sensor. In an embodiment, the mouthpiece may be anchored to the user&#39;s upper teeth to the hard palate. The nasal airway obstructor fits over a user&#39;s nose. In another embodiment, the device may be powered by physical clenching of a user, an electrical battery pack, an external power supply, or a combination thereof. 
         [0013]    A method of treating bruxism includes providing the device comprising a mouthpiece and nasal airway obstruction member. The mouthpiece and associated pressure sensor may be anchored to the upper teeth, lower teeth, or both of a user and the nasal airway obstruction member is placed adjacent to the user&#39;s nasal region. Upon receiving a signal from the pressure sensor the nasal airway passage of the user is obstructed. After a predetermined amount of time the nasal airway passage blockage is released. In an alternative method, when the user unclenches, the nasal airway obstruction member ceases obstruction of nasal respiration. Still further, a data processing unit is capable of recording when the user clenches and unclenches his/her jaw. The data processing unit configured to communicate with a smart device and a software applet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  illustrates an example embodiment of a bruxism treatment device; 
           [0015]      FIG. 2  shows an alternative example embodiment of a bruxism treatment device; 
           [0016]      FIG. 3  shows an example embodiment of a mouthpiece; 
           [0017]      FIG. 4  shows an example embodiment of a nasal obstructor; and 
           [0018]      FIG. 5  illustrates an example embodiment of the bruxism treatment device of  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0019]    Described herein is a device for the treatment of bruxism. A first embodiment may include a one-piece system, and a second embodiment may include a two-piece system. In either embodiment, the device includes a clench sensor and a nasal airway obstructor. 
         [0020]      FIG. 1  illustrates an example embodiment of a bruxism treatment device  300 . Bruxism treatment device  300  includes mouthpiece  302 , clench sensor  301 , and nasal airway obstructor  400 . In an example embodiment, clench sensor  301  is embedded within mouthpiece  302 . Alternatively, clench sensor  301  may be disposed on a top or bottom of the mouthpiece  302 . Nasal airway obstructor  400  includes nasal obstructors  421  and electro-mechanism drives  422 . The mouthpiece  302  is operatively connected to nasal airway obstructor  400  to provide a means of communication. 
         [0021]      FIG. 2  illustrates an example embodiment of a two-piece bruxism treatment device  300 . Mouthpiece  302  may be separate from nasal airway obstructor  400 . Mouthpiece  302  includes clench sensor  301  and wireless signal transmitter  303 . Nasal airway obstructor  400  includes hood  411 , seal  413 , and straps  412   a ,  412   b . Hood  411  may be sized and shaped to cover a user&#39;s nose, for example in a cup or hood configuration. Seal  413  encircles an edge of hood  411  to create seal of hood  411  against a user&#39;s face. Straps  412   a ,  412   b  extend from either side of nasal airway obstruct  400  and around a user&#39;s head. 
         [0022]    The mouthpiece  302  is shown in more detail at  FIG. 3 . Mouthpiece  302  include at least one clench sensor  301 . Clench sensor  301  detects the clenching behavior of a user and sends a feedback signal (biofeedback) to the nasal airway obstructor  400 . In one embodiment of the invention, the clench sensor  301  is embedded in mouthpiece  302 . The clench sensor  301  can be an electrical switch, strain gauge, piezoelectric crystal, fluidic displacement device, or other similar mechanism. A wireless signal transmitter  303  (not shown) can be embedded in the mouthpiece  302  to transmit the clench data to the data processing unit  416  electromagnetically in either a one-piece system or a two-piece system. Alternatively, in a one-piece system, a clench sensor  301  can communicate the clench behavior to the nasal airway obstructor  400  via passages  304 , which are contained within a conduit connection  305 . Conduit connection  305  extends through the lips of the user to the data processing unit  416  of the nasal airway obstructor  400 . 
         [0023]    Mouthpiece  302  may be a variety of sizes and shapes. In an embodiment, the mouthpiece  302  may be custom fitted to the user&#39;s teeth. An example mouthpiece  302  may cover the top teeth, the bottom teeth, or both. Example materials of a mouthpiece  302  may include an elastic material such as rubber or plastic, or may be an inelastic material such as other plastics with little or no flexibility. 
         [0024]    The clench signal can be transmitted electrically, electromagnetically, mechanically, via fluid power transmission, or other similar mechanism. In an alternative embodiment, bruxism treatment device  300  may accomplish clench detection utilizing physical or electrical feedback from the external musculoskeletal structure of the user&#39;s orofacial region. 
         [0025]    The nasal airway obstructor  400  obstructs the user&#39;s nasal airway to prevent the user from breathing through their nose. In an embodiment of the invention shown in  FIG. 4 , the nasal airway obstructor  400  is comprised of a nasal hood assembly, which is comprised of a cup-shaped hood  411  and is held to the user&#39;s face with straps  412   a ,  412   b  and maintains an airtight seal  413  to the user&#39;s face and encloses the nose. An airway valve  414  may control airflow into hood  411 . The airway valve  414  can be a high flow, low resistance valve. An example airway valve  414  may be a motorized butterfly valve with a data processing unit. The airway valve  414  is actuated by an electro-mechanical drive  415  and is controlled by a data processing unit  416  to allow normal, unobstructed respiration through the hood  411  when the user is not clenching. When the user is clenching, the data processing unit  416  controls the airway valve  414  via the electro-mechanical drive  415  to obstruct the user&#39;s air supply partially or fully. 
         [0026]    The bruxism treatment device  300  can be powered by the physical clenching action of the user, an electrical battery pack contained within the assembly, or an external power supply. The mouthpiece  302  of  FIG. 3  and the nasal airway obstructor  400  of  FIG. 4  can be used together to form a two-piece system. When clench sensor  301  receives a signal that the user is clenching his/her jaw, a signal is sent to nasal airway obstructor  400 , which blocks air flow to the nostrils, thereby forcing the user to breathe through his/her mouth. The bruxism treatment device  300  may also include a power source. The power source may be external to the device to provide power to the device through a battery or electrical cord. Alternatively, the bruxism treatment device  300  may be powered by the physical clenching action of a user. 
         [0027]      FIG. 5  illustrates an example embodiment of a one-piece bruxism treatment device  300 . The clench sensor  301  is incorporated into the mouthpiece  302  and is connected to the nasal airway obstructor  400  via a rigid strut  501 . The rigid strut  501  is routed through the user&#39;s lips to the nasal airway obstructor  400 . The bruxism treatment device  300  is anchored via the mouth piece  302  and upper teeth to the user&#39;s hard palate. The rigid foundation of the hard palate allows the nasal obstructors  421  to be held via the rigid housing  502  in the correct orientation about the user&#39;s nostrils. Nasal obstructors  421  function by the actuation of two linear actuators that are held in the correct orientation as to collapse the user&#39;s nostrils and seal-off the airway when actuated. The linear actuators can be driven by electro-mechanical drives  422 , mechanical power transmission, or fluidic power transmission (hydraulic or pneumatic). The rigid housing  502  of the bruxism treatment device  300  may contain a data processing unit  416 , power source (not shown), or other power transmission apparatus from the clench sensor  301 . Other power transmission apparatuses may be mechanical or fluid. 
         [0028]    The one-piece configuration could also utilize a hood  411 , a nasal pillow type manifold (not shown), or any other manner of controllable nasal airway stoppers as a nasal airway obstructor  400 . Other nasal airway stoppers may include a mask, a physical plug, or other similar mechanism. Nasal airway obstructor  400  may be rigid, or alternatively may be pliable. These nasal airway obstructions may communication with the mouthpiece via an electrical, electromagnetic, mechanical, fluid transmission, hydraulic transmission, or other similar mechanism. 
         [0029]    The described invention may utilize data processing algorithms to control the airway obstructor in a way to best treat the user. This may include limiting the degree to which the airway is obstructed and the amount of time that the airway is obstructed. Data collection is also possible for the purpose of tracking the user&#39;s clenching behavior and improvement. Such data may be transmittable to a computer, phone, a smart device, or other electronic device for review. 
         [0030]    In use, the mouthpiece  302  is anchored to a user&#39;s upper teeth or lower teeth and the nasal airway obstructor  400  is placed over a user&#39;s nasal region. When a user clenches his/her jaw, a signal is sent to the nasal airway obstructor, which blocks air flow to the nostrils of the user, forcing the user to breathe through his/her mouth. Airflow to the nostrils is restored after a predetermined period of time. Such a time period may be 5 seconds, 10 seconds, or up to 30 seconds. Alternatively, a time period may be once the user unclenches his/her jaw. 
         [0031]    The following patents are incorporated by reference in their entireties: U.S. Pat. Nos. 5,078,153; 6,164,278; and 8,020,276. 
         [0032]    While the invention has been described above in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Upon reading the teachings of this disclosure many modifications and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings.