Abstract:
A new innovative and unique solution to minimize the problems of mouth leakage using a CPAP machine is disclosed. A mouthpiece module is specifically designed to solve the problem of mouth leakage which compromises the therapeutic effect of CPAP treatment. The mouthpiece module comprises a flexible absorbent material which partially wraps around the lips and is secured to the back of the head by straps or an elastic band. In one embodiment, the mouthpiece is detachable from a securement strap.

Description:
BACKGROUND 
       [0001]    Continuous Positive Airway Pressure (CPAP) is an effective treatment for sleep apnea. A CPAP machine delivers a positive pressure on airways of a patient. The positive pressure keeps the patient&#39;s airways open to avoid cessation of breathing related to airway closure that may occur in various stages during the sleep of a patient. 
         [0002]    The present disclosure relates to a mouthpiece that is specifically designed to be used for the prevention of mouth leaks that can occur with the use of a CPAP machine that is used as a treatment in therapy for sleep apnea. 
         [0003]    The airflow pressure produced by a CPAP machine is higher when compared to normal breath pressure and, as a result, a major problem that can be experienced by the patient is air leakage from the mouth. Mouth leaks, if not corrected, can compromise the patient&#39;s treatment to the extent that the treatment can become ineffective. Other effects can be that the patient complains of a dry mouth which is caused by the CPAP air escaping through the mouth. This is brought about by the effect of higher than normal breathing pressure which tends to “dry out” the oral and nasal cavity due to the CPAP pressure being exhaled through the mouth rather than being delivered to the patient&#39;s lungs via the airway and exhausted through the exhaust vent of the CPAP mask. The result of this is that the CPAP pressure can be compromised and adequate pressures are not maintained to optimize the patient&#39;s treatment. 
         [0004]    At present, there are four well-known options that can be used by patients to minimize the problem of mouth leakage. The first of these methods is for a patient to learn to maintain a closed mouth without an aid. To this end, some people position the tongue behind the top teeth which forces the back of the tongue to spread towards the side of the mouth creating a seal so that the CPAP works. The second option is to use a full face mask. If a person typically breathes through the mouth, a full face mask is almost always required. A third option is the use of a chin strap. Chin straps are a simple device and comprise a chin support pouch made from fabric with straps fitted that are secured in position over the top of the head. The disadvantage of a chin strap is that it can be quite uncomfortable to wear, leaves strap marks on the face after prolonged use, can become loose during sleep with patient movement and can still allow mouth leakage if not adjusted and tightened correctly. The fourth method is mouth taping. Mouth taping is typically a desperation method and very unadvisable. Aside from being inconvenient and uncomfortable, mouth taping can cause a very unsafe condition if a patient&#39;s nose becomes obstructed, the patient has acid reflux, the patient regurgitates or the CPAP is disconnected and the patient needs to breathe through the mouth. 
         [0005]    Continuous Positive Airway Pressure (CPAP) machine users as they grow older commonly experience a problem known as mouth leakage that develops with their lips losing a degree of elasticity. When using their CPAP with a nose mask, their lips, through a loss of elasticity, open from the air pressure produced by the CPAP machine as they approach REM sleep. The air forcibly pushes its way through their lips, causing them to separate slightly, thereby resulting in a hissing sound, trembling and fluttering lips. The characteristics can impact the effective functionality of the CPAP machine to provide the necessary air flow for adequate breathing for apnea patients. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    Briefly stated, a mouth leak prevention device keeps the lips of a user sealed while using a nasal mask for a CPAP. The mouthpiece of this device has two opposite edges that generally traverse its length and two opposite ends that generally traverse its width. The mouthpiece is made of flexible and absorbent material. The mouthpiece is wider than the closed lips of a user. The device also has a pair of straps that extend from the ends of the mouthpiece a distance that is sufficient to ensure that the straps are secured at the back of the head of a user. In use, the straps are securable at the back of the head of the user, as the mouthpiece is extended in between and around portions of the lips of a user, to create an airtight seal at the mouth of the user. 
         [0007]    In one embodiment, the mouth leak prevention device can be made of a cotton cloth material. The device can also be made of various cloth materials, polyester, hemp, cotton, various composite textile materials or any combination thereof. The straps of the mouthpiece extend out from the ends of the mouthpiece as one piece or multiple pieces of material made substantially of the same material as the mouthpiece. 
         [0008]    In another embodiment, a mouth leak prevention device also keeps the lips of a user sealed while using a nasal mask for a CPAP and employs a mouthpiece. The mouthpiece has two opposite edges that generally traverse along its length and two opposite ends that generally traverse its width. The mouthpiece is made of flexible and absorbent material. The mouthpiece is wider than the closed lips of a user. The device also has a pair of straps that extend from the ends of the mouthpiece a distance that is sufficient to ensure that the straps are securable at the back of the head of a user. There is also a hook-and-loop fabric fastener on a portion of the straps to allow the mouthpiece to be removed and replaced. In use, the straps are secured at the back of the head of the user, as the mouthpiece is extended in between and around portions of the lips of a user, to create an airtight seal at the mouth of the user. 
         [0009]    In this second embodiment, the mouth leak prevention device can be made of a cotton cloth material or various other materials. The straps of the mouthpiece extend out from the ends of the mouthpiece as one piece or multiple pieces of material made substantially of the same material as the mouthpiece. A hook-and-loop fabric fastener can be attached to a portion of one of the straps or both of the straps. The hook-and-loop fabric fastener can be positioned at the portion of one or both straps either next to the ends of the mouthpiece or at the ends of the straps next to where the straps are securable to the back of the head of the user. 
         [0010]    In another embodiment, a mouth leak prevention device which keeps the lips of a user sealed while using a nasal mask for a CPAP employs a removable mouthpiece. The mouthpiece of this device has two opposite edges that traverse its length and two opposite ends that traverse its width. The mouthpiece is made of flexible and absorbent material. The mouthpiece is wider than the closed lips of a user. The device also has a securement means for securing the mouthpiece to the back of the head of a user. When in use, the mouthpiece is secured at the back of the head of the user, as the mouthpiece is extended in between and around portions of the lips of a user, to create an airtight seal at the mouth of the user. The securement means may also have features which allow for detachment of the mouthpiece. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0011]      FIG. 1  is a perspective view of a mouthpiece module for a CPAP machine; 
           [0012]      FIG. 2  is a frontal head view, partly in schematic, of a user wearing a nasal mask and the mouthpiece with the cloth portion in the mouth and sections wrapped around the head and tied in the back of the head and schematically illustrating a CPAP machine; 
           [0013]      FIG. 3  is an enlarged side view, partly in schematic, of the mouthpiece module installed in the mouth; 
           [0014]      FIG. 4  is a photograph of one embodiment of a mouthpiece module; 
           [0015]      FIG. 5  is an exploded diagrammatic view of another embodiment of a mouthpiece module; and 
           [0016]      FIG. 6  is an exploded view of yet another embodiment of a mouthpiece module. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    With reference to the drawings wherein like numerals represent like parts throughout the figures, a mouthpiece module, in accordance with the present disclosure, is generally designated by the numeral  10 . The mouthpiece module functions in conjunction with a nasal mask  12  for a CPAP machine  14  to prevent air leakage from the mouth while a user is using a CPAP machine. The nasal mask  12  can take many forms, and nasal mask  12  is intended to be representative of any of the various forms which can be employed. 
         [0018]    The mouthpiece module  10  is manufactured from a flexible absorbent cloth or textile material. The mouthpiece module is configured and dimensioned to rest between the lips of the user, as best represented in  FIG. 2 , and does not extend beyond the teeth. The preferred cloth or textile material for the mouthpiece module is preferably cotton, but may be polyester. Bamboo, fleece, fabric, hemp or elastic or other flexible absorbent materials may be employed. The preferred length of the mouthpiece module is 30-40 inches. Naturally, the mouthpiece module is healthful, clean and safe. 
         [0019]    The mouthpiece module  10  comprises a rectangular, quasi-rectangular, oval or generally elongated mouthpiece  20 . The mouthpiece has a top edge  22 , an opposed second edge  24  and opposed ends  26  and  28 . The mouthpiece has a length which exceeds the length of the lip interface of the user when the lips are closed. The preferred dimensions of the mouthpiece  20  are 1-3 inches in width and 3-5 inches in length. 
         [0020]    A pair of straps  30  and  40  extend from a medial location of the opposed ends  26  and  28 . In one embodiment, the straps  30  and  40  each have a length which is more than sufficient to extend around the head of the user and to provide sufficient end material for comfortably tying the straps in a knot at the back of the head of a user. The preferred width of the straps  30  and  40  is ¼-½ inch. The straps  30  and  40  are non-irritating and comfortable. 
         [0021]    The ends of the straps may alternatively be secured by a pin, clasp or various fasteners or, in some embodiments, even by an elastic connector or hook-and-loop fabric (Velcro™) fastener. In addition, as best illustrated in  FIG. 2 , the upper and lower flexible panel portions  50  and  60  of the mouthpiece  20  engage around the upper and lower lips of the user in a reverse fold fashion, as best illustrated in  FIG. 3 . 
         [0022]    In some embodiments, the straps may be stitched to the ends of the mouthpiece  20 . In other embodiments, the straps may simply integrally extend from the mouthpiece. In another embodiment, the straps may also be a single continuous elastic band, stitched or integral to the mouthpiece  20 . Any of the above securing means are suitable for securing the straps at the back of the head so that the mouthpiece is firmly secured in the mouth. 
         [0023]    Once the mouthpiece  20  is properly positioned and retained in place to the user, it will be appreciated that the mouthpiece provides a flexible comfortable structure which prevents airflow from the mouth. In addition, the absorbent material from the mouthpiece will absorb any moisture in the oral cavity which impinges in the lip area. 
         [0024]    With reference to  FIG. 5 , another embodiment of a mouthpiece module is generally designated by the numeral  100 . Mouthpiece module  100  comprises a rectangular or quasi-rectangular elongated mouthpiece  120 . The mouthpiece module  100  is especially adapted so that the mouthpiece  120  may be dismounted and replaced by another or a new mouthpiece as required. In this regard, the mouthpiece may be replaceable or, in some cases, disposable. 
         [0025]    The mouthpiece  120  has a top edge  122 , an opposed second edge  124  and opposed ends  126  and  128 . It should be appreciated that, depending on the mouthpiece geometry, the edges and ends may not have a well-defined point of demarcation. The mouthpiece  120  has a length L 2  (which exceeds the length of the lip interface of the user when the lips are closed) and has a width W 1 . A pair of connectors or tab-like appendages  150  and  160  extend from a medial portion of the ends  126  and  128 , respectively. The appendages may be integral with the mouthpiece, stitched or otherwise connected. The opposite ends of the appendages mount a fastener, such as a portion of a hook-and-loop or Velcro™-type fabric fastener  152  and  162 , respectively. The length of each fastener is designated by the length L 3 . 
         [0026]    Straps  130  and  140  which, in one embodiment, are preferably separate segments, each include a mating fastener, such as a second Velcro™ fastener, hook-and-loop fabric, or Velcro™-type fastener portion  132  and  142  which connect with the fastener portions  152  and  162 , respectively, in overlapping relationship. The straps  130  and  140  are preferably substantially identical and have a width designated as W 2 . When the straps are connected to the appendages  150  and  160 , the maximum longitudinal distance between the free ends of the straps is designated by L 1 . The length L 1  is sufficient that the straps may be either tied or otherwise connected at the back of the head of the user. The straps may include various mechanical fasteners for fastening the straps at the back of the head of the user. The preferred maximum dimension L 1  is between 30 and 40 inches. 
         [0027]    In one embodiment, the straps may essentially be connected end-to-end at ends  135  and  145  or seamlessly joined so that components  130  and  140  are essentially strap segments of continuous band and the strap has sufficient elasticity so that it can be wrapped around the back of the head of the user and be sufficiently taut to mount the mouthpiece module in a proper taut installed position, such as illustrated in  FIG. 2 . 
         [0028]    Table 1 set forth below illustrates representative samples for various different dimensioned embodiments of mouthpiece module  100 . The fasteners are connected to the straps  130  and  140  so that the proximal end of the straps include a tab  134  and  144  to allow for easy removal or disconnection of the straps from the tab appendages. 
         [0000]    
       
         
               
               
               
               
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Ex. 
                 W 
                 W2 
                 L1 
                 L2 
                 L3 
               
               
                   
                   
               
             
             
               
                   
                 1 
                 2 
                 ⅜ 
                 37 
                 5 
                 ½ 
               
               
                   
                 2 
                 3 
                 ⅜ 
                 37 
                 5 
                 ½ 
               
               
                   
                 3 
                 2 
                 ⅜ 
                 37 
                 5 
                 2 
               
               
                   
                 4 
                 3 
                 ⅜ 
                 37 
                 5 
                 2 
               
               
                   
                 5 
                 2 
                 ⅜ 
                 37 
                 5 
                 3 
               
               
                   
                 6 
                 3 
                 ⅜ 
                 37 
                 5 
                 3 
               
               
                   
                 7 
                 2 
                 ⅜ 
                 37 
                 5 
                 4 
               
               
                   
                 8 
                 3 
                 ⅜ 
                 37 
                 5 
                 4 
               
               
                   
                   
               
               
                   
                 W1 - Width of mouthpiece (inches). 
               
               
                   
                 W2 - Width of straps (inches). 
               
               
                   
                 L1 - Length of entire mouth leak prevention device (inches). 
               
               
                   
                 L2 - Length of mouthpiece (inches). 
               
               
                   
                 L3 - Length of hook-and-loop fastener (inches). 
               
             
          
         
       
     
         [0029]    With reference to  FIG. 6 , the mouthpiece module  200  is configured to attach around the ears of the user to mount the mouthpiece  120  in position as previously described. Straps  230  and  240  are preferably identical and respectively mount an elastic loop  232  and  242 . Each loop is dimensioned and configured so that they loop around the ears of the user. The elastic loops  232  and  242  are preferably formed from thin elastic and attached to fastener portions  252  and  262 . The mouthpiece  120  may be similar in form and function to that described for the mouthpiece of  FIG. 5 . 
         [0030]    While preferred embodiments of the foregoing have been set for purposes of illustration, the foregoing description should not be deemed a limitation of the invention herein. Accordingly, various modifications, adaptations and alternatives may occur to one skilled in the art without departing from the spirit and the scope of the present invention.