Abstract:
An oral orthosis includes a holder in the shape of a mouthpiece, including a curved arcuate trough-like upper section which receives a formable material. The formable material does not occupy the entire trough but rather includes voids between the formable material and the inner surfaces of trough of the holder to allow expansion of the formable material into the voids during the molding process when tooth pressure is placed on the formable material. This design results in elimination of the excess formable material which otherwise would require removal by trimming. Additionally, the formable material is placed in the trough in a configuration which includes indexing indentations along the centerline of the material, such that, during the molding process, the mouthpiece containing the formable material is easily centered along the edges of the user&#39;s teeth to provide a precise fitting.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 12/652,387, filed on Jan. 5, 2010, entitled O RAL  O RTHOSIS , by Jeffrey Joe Fisher et al., now U.S. Pat. No. 8,322,344, which issued Dec. 4, 2012, the entire disclosure of which is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to an oral orthosis with improved molding characteristics. 
     Oral orthoses are typically shaped like mouthpieces which include a holder in the form of a curved tray made of a semi-rigid polymeric material, such as polycarbonate. The holder is filled with a moldable polymeric material for use by a dental professional or consumer in shaping the interior moldable content of the mouthpiece into a comfortable, tooth-conforming mouthpiece. Such orthoses are employed for in a variety of applications such as mouth guards for sporting events, bite guards to treat Bruxism at night, and snore prevention devices which are designed to urge the lower jaw slightly forwardly to provide clearance between the rear of the tongue and the uvula, which is the source of vibration causing objectionable snoring noise. The structure of the present invention can be employed in all such orthoses and in other similar applications; however, the invention is described in particular relationship to a snore prevention device. 
     Several such snore prevention devices are commercially available both for use by dentists and consumers directly in which the consumers position the unformed snore prevention device in boiling water and subsequently insert it in their mouths with their lower jaw projected forward slightly to allow the softened filler material to set and shape the mouthpiece, including the holder and moldable material, in a tooth-conforming configuration. Typically, both the upper and lower teeth are imprinted in the material which, when hardened, forms a finished snore prevention device which can be used on a nightly basis. With existing snore prevention devices, the filler material, however, when displaced by the teeth during the molding process, overfills the holder and results in excess material which is uncomfortable to the wearer&#39;s gums. The excess material must be trimmed and smoothed to provide the wearer with a comfortable finished product. 
     Thus, although snore prevention devices are effective in preventing or reducing snoring in individuals, the molding of the snore prevention devices by individuals and, particularly by the consumers themselves, frequently results in a less than desirable fit for comfort or, if a dental care professional is fitting such a device, it requires additional work, thereby increasing the cost to the consumer, There exists a need, therefore, for an improved snore prevention device which can be molded by the consumer, which is relatively inexpensive, easy to use, provides a comfortable fit, and is effective in preventing snoring. 
     SUMMARY OF THE INVENTION 
     The orthosis of the present invention satisfies this need by providing a holder in the shape of a mouthpiece, including a curved arcuate trough-like upper section which receives a formable material. The formable material does not occupy the entire trough but rather includes voids between the formable material and the inner surfaces of the trough of the holder to allow displacement of the formable material into the voids during the molding process when tooth pressure is placed on the formable material. This design results in elimination of the excess formable material which otherwise would require removal by trimming. Additionally, the formable material is placed in the trough in a configuration which includes indexing indentations along the centerline of the material, such that, during the molding process, the mouthpiece containing the formable material is easily centered along the edges of the user&#39;s teeth to provide a precise fitting. 
     In a preferred embodiment of the invention, the holder further includes air-escape apertures in at least one surface of the trough, such that, during the molding process, air can escape from the void as pressure is applied to the formable material, In another preferred embodiment of the invention, the trough filler material includes an indexing recess and tab, respectively, for centering the orthosis, such as a snore prevention device, with the front teeth. In such an application the holder further includes a lower pedestal which includes formable material to be impressed with the user&#39;s lower teeth and urge the user&#39;s lower jaw slightly forwardly during the molding process. 
     Thus, with the present invention, an improved orthosis is, provided that eliminates or greatly reduces any excess formable material resulting in a comfortable orthosis which can be easily employed by a consumer to provide a comfortable and effective device to reduce or eliminate snoring. 
     These and other features, objects and advantages of the present invention will become apparent upon reading the following description thereof together with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a rear perspective view of a snore prevention device embodying the present invention; 
         FIG. 2  is a front perspective view of the snore prevention device shown in  FIG. 1 ; 
         FIG. 3  is a top plan view of the snore prevention device shown in  FIGS. 1 and 2 ; 
         FIG. 4  is an enlarged cross-sectional view of the snore prevention device taken along section line IV-IV in  FIG. 3 ; 
         FIG. 5  is an enlarged cross-sectional view of the snore prevention device taken through section line V-V of  FIG. 3 ; 
         FIG. 6  is a front elevational view of the snore prevention device shown in  FIGS. 1-3 ; and 
         FIG. 7  is a right side elevational view of the snore prevention device shown in  FIG. 6 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring initially to  FIGS. 1-3 , there is shown a orthosis embodying the present invention. The invention can be employed for making a variety of different orthoses as noted above however, for purposes of illustration, an orthosis such as a snore prevention device  10  embodying the present invention is described as one preferred embodiment. The snore prevention device  10  comprises two basic elements including a semi-rigid outer member or holder  20  and a formable filler material  50  within the holder. The holder  20  is generally in the shape of a mouthpiece and includes an arcuate trough  22  ( FIGS. 4-5 ) at an upper section thereof. The trough is defined by a front arcuate wall  24 , a rear arcuate wall  26  spaced from said front wall, and a floor  28  ( FIGS. 4 and 5 ) integrally joining the walls. Holder  20  also includes a downwardly projecting pedestal  30  integrally molded to the floor and coupled to the outer lower surface  29  ( FIG. 6 ) of floor  28  by a pair of integral spaced-apart legs  32  and  34  defining an air transmission or breathing slot  40  between the lower surface  29  of trough floor  28  and the upper surface  35  of pedestal  30 . Slot  40  extends through the snore prevention device  10  to provide a passageway for air between the lips of the user when the snore prevention device is in place. 
     The holder  20  is typically made of a resilient, semi-rigid polymeric material, such as polycarbonate or methylmethacrylate, although the thermoplastic resin preferred is polycarbonate made by the General Electric Company and sold under the trademark Lexan®. The three-dimensional shape of the holder  20  is molded in a conventional injection molding machine such that trough  22  of holder  20  is generally semicircular (as viewed from the top view of  FIG. 3 ) and has a generally U-shaped cross section, as seen in  FIGS. 4 and 5 . The front wall  24  of the trough  22  is curvilinear and generally lip-shaped (i.e. generally higher toward the middle and shorter at the outer edges). Wall  24  has a concave indentation  25  at the center for assisting in centering the mouthpiece in alignment with the front teeth of a person&#39;s mouth during the molding process described below. The curvilinear top edge  27  of wall  24  curves downwardly toward the ends  42  and  44 , which are substantially flat, and integrally join with the rear wall  26 , which extends upwardly toward the center and is flattened at plateau  29 , which is slightly lower than the notch  25  in the front wall  24 . The holder includes air escape apertures and in one embodiment they are formed in the rear wall  26  which includes a plurality of apertures  31  ( FIG. 1 ) which allow air to escape the trough  22  as teeth displace the formable material during the molding process described below. 
     The formable or moldable material  50  which is positioned in the holder  20  for molding to the shape of the user&#39;s mouth and teeth preferably comprises an ethylene vinyl acetate copolymer resin. This material, or its equivalent, has a softening and molding temperature of between about 125° F.-175° F. and preferably about 150° F. Such material is sold by the E. I. DuPont de Nemours &amp; Company under the trademark Elvax®. The material  50  is injection molded in a second molding step in which the holder  20  is positioned within a mold and the material  50 , in the shape shown in  FIGS. 1-7 , is injection molded to partially fill the trough  22 . The filler material is smaller than the trough  22 , leaving voids  51  and  53  near the front wall  24  as best seen in  FIG. 3 , and voids  52  and  54  in the edges adjacent rear wall  26 . This leaves, as also seen in  FIG. 5 , voids which allow the material  50  to flow into the trough  22  without overfilling and leaving excess material over the edges of the holder  20 , Pedestal  30  likewise has formable material  50  injection molded in a curved pattern having a concavity  56 , as best seen in  FIGS. 6 and 7 , and a ramp  36  to generally urge the lower jaw forwardly as the consumer forms the formable material  50  in his or her jaw between upper and lower teeth. Material  50 , at the interface with pedestal  30 , follows the inclined shape  36  of pedestal  30 , as best seen in  FIG. 7 . The concavity  56  likewise represents a void into which the material  50  can be displaced during the fitting process, further reducing trimming. 
     The material  50  in the upper trough  22  includes a raised curvilinear indexing land  58  to provide a guide for centering the device in conjunction with the notch  25  located between the front teeth when placed in the user&#39;s mouth, The moldable insert material  50  also includes an arcuate alignment trough  59  on either side of the center land  58  which extends in an arcuate curve toward ends  42  and  44  for also assisting in centering the edges (i.e. biting surfaces) of the upper teeth within the holder  20  in alignment with the moldable filler material  50   
     In one embodiment of the invention, the arcuate length of the holder  20  along the outer wall  24  was about 3¼ inches and circumscribed and arc of approximately 180° and was substantially semicircular. The inner wall had an overall arc length of about 2 1/4  inches while the maximum depth of the trough  22  was approximately ¼ inch. Voids  51 - 54  have a gap width of approximately from about 0.030 to about 0.070 inches and in one embodiment were 0.040 inches. The voids have a depth of from about 0.030 inches to about 0.190 inches and in one embodiment had a depth of approximately 0.190 inches at the deepest section near the crown in wall  24  adjacent notch  25 . The arc length for the front pair of voids  51 ,  53  are about 0.70 inches each and the rear pair  52 ,  54  are about 0.40 inches each. It is important that the sum of the volume of the voids are close to the average sum of the volume of the average teeth that will form the impressions. That can be accomplished by varying the proportions and/or number of voids. The limiting factor to any configuration is that the teeth should be adequately surrounded after forming to maintain the proper position of the orthosis. 
     Breathing slot  40  is sized to provide sufficient air for comfortable breathing and is tapered from front to back. In one embodiment it had an opening at the front of about 0.75 inches when viewed from  FIG. 6  and is tapered rearwardly to an opening of approximately 0.06 inches at the rear of the slot. Its height (in one embodiment) was approximately 0.1 inch. These dimensions of the mouthpiece can be varied, although the dimensions given are for a snore prevention device which will comfortably fit most averaged sized mouths. The molded insert material  50  naturally adheres to holder  22 ; however, the floor  28  of holder  22  includes two circular apertures  21  and  23 , as seen in  FIG. 3 , for receiving material  50  for locking it securely in place. 
     In use, the orthosis shown in the figures is held by a suitable holder (not shown) a vessel of boiling water for a period of time such that the formable material becomes softened. Since material  50  has a significantly lower softening temperature than that of the polycarbonate holder  20 , immersion of the device in a heated fluid, such as boiling water, prior to fitting softens the material  50  to accept the user&#39;s tooth pattern. The fitting is accomplished by removing the snore prevention device  20  from the boiling water, allowing it to cool for a short period of time, and inserting the device into the user&#39;s mouth with the notch  25 , indexing land  58 , and alignment trough  59  guiding the positioning of the device into one&#39;s mouth. The tapered concavely curved edge  56  engages the inside of the lower teeth and tends to move the jaw slightly forwardly during the molding process. The user need only grip the snore prevention device between his/her teeth for 30 seconds or so to allow the thermoplastic filler  50  to set in a comfortable, upper and lower teeth engaging configuration, whereupon the device can be removed. It then contains a permanent imprint of the user&#39;s upper and lower teeth in which the lower teeth engage edge  56  of the pedestal to urge the lower jaw slightly forwardly in an amount of typically from about 2 mm to about 6 mm, sufficient to provide clearance between the back of the tongue and uvula to prevent or greatly reduce snoring during sleep. 
     The durable material is employed for the snore prevention device  10  to hold its shape and be useful for a significant amount of time and can be periodically sanitized as desired by the user and stored when not in use. Although the dimensions given are for medium sized snore prevention devices, it should be understood that the dimensions can be proportionally varied to make larger or smaller snore prevention devices as desired. The provision of the self-alignment guides, as well as the voids and air escape apertures or vents, provides an orthosis which, upon impressing the tooth pattern, does not result in an excess amount of material which must be trimmed for comfort and allows immediate use without such a step. The formable material  50  and/or the holder  20  can be colored to color code the snore prevention device for an individual user. 
     It will become apparent to those skilled in the art that various modifications to the preferred embodiment of the invention as described herein can be made without departing from the spirit or scope of the invention as defined by the appended claims.