Abstract:
A method of forming a user conformable dental guard includes obtaining a storage case with a handle, and inserting a dental guard and an impression tray in which the dental guard is positioned into the storage case. The method includes filling the storage case with water and placing the storage case and its contents into a microwave oven. The storage case and its contents are then subjected to microwave energy for a period of time sufficient to soften the dental guard. The method includes removing the storage case from the microwave over, flushing the storage case with water to slightly cool the dental guard, removing the dental guard and impression tray from the storage case and inserting the dental guard and impression tray into the user&#39;s mouth. The dental guard is molded by application of force by the user&#39;s teeth.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/692,121, filed Aug. 22, 2012, entitled “DENTAL GUARD SYSTEM AND METHOD FOR FORMING.” 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a nighttime dental guard, impression tray, storage case and process of forming the dental guard using a microwave oven. 
         [0004]    2. Problem Solved 
         [0005]    The present invention overcomes the problems with the numerous other dental guards on the market in that it is made from a material which can absorb microwave energy and soften such that it can be molded by a user&#39;s teeth. The other products on the market do not work when subject to microwave heating. They must be heated in a pot of boiling water. The present invention is heated by microwave energy and not boiling water. 
       SUMMARY OF THE INVENTION 
       [0006]    It is, therefore, an object of the present invention to provide a method of forming a user conformable dental guard. The method includes obtaining a storage case with a handle, wherein the storage case is made from a thermoplastic material that does not change shape when subjected to microwave energy during the method of forming, and inserting a dental guard and an impression tray in which the dental guard is positioned into the storage case. The dental guard softens when subject to microwave energy and has an upper surface and a lower surface. The method also includes filling the storage case with water and placing the storage case, with the water, the dental guard and the impression tray therein, into a microwave oven. The storage case, the water, the dental guard and the impression tray are then subjected to microwave energy for a period of time sufficient to soften the dental guard. The handle is then grasped and the storage case is removed from the microwave oven. The method also includes flushing the storage case with water to slightly cool the dental guard, removing the dental guard and impression tray from the storage case and inserting the dental guard and impression tray into the user&#39;s mouth. The dental guard is molded by application of force by the user&#39;s teeth to the upper surface of the dental guard and a lower surface of the impression tray. 
         [0007]    It is also an object of the present invention to provide a method of forming a user conformable dental guard wherein after the application of force the dental guard is removed from the impression tray. 
         [0008]    It is another object of the present invention to provide a method of forming a user conformable dental guard wherein the storage case includes a base and a cover with vent holes, and wherein the step of inserting includes closing the cover upon the base after the dental guard and impression tray have been placed within the storage case. 
         [0009]    It is a further object of the present invention to provide a method of forming a user conformable dental guard wherein the step of filling of the storage case with water is performed by pouring the water through the vent holes in the cover. 
         [0010]    It is also an object of the present invention to provide a method of forming a user conformable dental guard wherein the vent holes function to insure the storage case is filled with a correct amount of water as any excess water will simply flow out of the vent holes when the cover is closed upon the base. 
         [0011]    It is another object of the present invention to provide a method of forming a user conformable dental guard wherein the vent holes allow for the venting of water vapor when the storage case, the water, the dental guard and the impression tray are subjected to microwave energy. 
         [0012]    It is a further object of the present invention to provide a method of forming a user conformable dental guard wherein the step of flushing includes grasping the handle and flushing the storage case with tap water. 
         [0013]    Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a perspective view showing the storage case containing the impression tray and dental guard prior to forming. 
           [0015]      FIG. 2  is a top perspective view of an impression tray. 
           [0016]      FIG. 3  is a front view of an impression tray. 
           [0017]      FIG. 4  is a top view of an impression tray. 
           [0018]      FIG. 5  is an upside down rear view of an impression tray. 
           [0019]      FIG. 6  is a side view of an impression tray. 
           [0020]      FIG. 7  is a cut away view along line  7 - 7  of  FIG. 4  of an impression tray. 
           [0021]      FIG. 8  is a rear view of an impression tray showing the beveled upper edges of exterior and interior upstanding wall members in detail. 
           [0022]      FIG. 9  is a top perspective view of the dental guard prior to forming. 
           [0023]      FIG. 10  is a perspective view of an open storage case containing an impression tray. 
           [0024]      FIG. 11  is a front view of a closed storage case. 
           [0025]      FIG. 12  is a top perspective view of the dental guard prior to forming. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0026]    The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as a basis for teaching one skilled in the art how to make and/or use the invention. 
         [0027]    In accordance with the present invention, and with reference to  FIGS. 1 to 11 , a dental guard system  10  is shown. The dental guard system  10  includes a user conformable dental guard  100 , an impression tray  200  and storage case  300 . The dental guard  100  once formed provides users with protection from undesirable jaw clenching and/or tooth grinding while they sleep; that is, bruxism. 
         [0028]    Referring to  FIG. 1 , the present dental guard system  10  includes an impression tray  200  and a formable dental guard  100 . The formable dental guard  100  is shaped and dimensioned for positioning within the impression tray  200  during the forming process. The impression tray  200  is preferably formed from a relatively rigid biocompatible thermoplastic, for example, polypropylene or polyethylene, that will not change shape when subjected to heat or microwave energy. As will be appreciated based upon the following disclosure, the formable dental guard  100  is also manufactured from a biocompatible thermoplastic. However, the biocompatible thermoplastic from which the formable dental guard  100  is formed is a material permitting softening of the thermoplastic to allow for custom forming of the formable dental guard  100  upon the application of heat and/or microwave energy. 
         [0029]    The present dental guard system  10  also includes a storage case  300  which is shaped and dimensioned for use in the forming process, while also providing a storage case for the dental guard  100  after it has been formed in accordance with the present invention. As such, and as with the impression tray  200 , the storage case  300  is preferably formed from a relatively rigid biocompatible thermoplastic that will not change shape when subjected to heat or microwave energy when forming a dental guard of the present invention, for example, polypropylene. 
         [0030]    With regard to the impression tray  200  shown in  FIGS. 2-8 , it is preferably an injection molded biocompatible thermoplastic. As discussed above, the impression tray is preferably manufactured from polypropylene or polyethylene. The impression tray  200  is substantially U-shaped and includes cavity  202  in which the formable dental guard  100  sits while applying microwave energy and heat, as well as during the forming process. As such, the impression tray  200  includes a first lateral side section  204  and second lateral side section  206 , the first and second lateral side sections  204 ,  206  being connected by an arcuate center section  208 . It is appreciated the impression tray  200  is integrally formed. As such, the first lateral side section  204  includes an exterior upstanding wall member  210  and an interior upstanding wall member  212 , the exterior and interior wall members  210 ,  212  being connected by a base member  214  extending therebetween. Similarly, the second lateral side section  206  includes an exterior upstanding wall member  210  and an interior upstanding wall member  212 , the exterior and interior wall members  210 ,  212  being connected by a base member  214  extending therebetween. The arcuate center section  208  also includes an exterior upstanding wall member  210  and an interior upstanding wall member  212 , the exterior and interior wall members  210 ,  212  being connected by a base member  214  extending therebetween. The base member  214  of the respective first lateral side section  204 , the second lateral side section  206  and the arcuate center section  208  each include an upper surface  214   a  upon which the lower surface  110  of the dental guard  100  sits during the forming process and a lower surface  214   b  shaped and dimensioned for engaging the lower teeth of a user during the forming process. The base member  214  is flat in first and second lateral side sections  204 ,  206 , but curves upwardly at  214   c  in arcuate center section  208  as best shown in  FIG. 7 . This results in upper surface  214   a  in the arcuate center section being slightly convex. The bottom surface  110  of the dental guard  100  matches the contour of upper surface  214   a.    
         [0031]    The upper edge  220  of exterior upstanding wall member  210  in lateral side sections  204 ,  206  and the upper edge  230  of interior upstanding wall member  212  in lateral side sections  204 ,  206  maybe beveled in order to aid in directing the rear teeth approximate the first lateral side section  204  and second lateral side section  206  of the impression tray  200  into the dental guard  100  when forming. The beveled edges function as a wedge to force one&#39;s teeth inward into contact with the dental guard to be formed. Additionally, the exterior upstanding wall  210  in the arcuate center section  208  includes a raised area  222  having an alignment notch  225  used for centering the front of the impression tray  200  between the two front teeth of a user. 
         [0032]    As is appreciated, the impression tray  200 , that is, the first lateral side section  204 , the second lateral side section  206  and the arcuate center section  208  are shaped and dimensioned so that the upper teeth of a user register with the dental guard  100  positioned therein. That is, the impression tray  200 , with the dental guard  100  positioned within the cavity  202  defined thereby, is shaped and dimensioned for positioning between the upper and lower teeth of the wearer. 
         [0033]    In accordance with a preferred embodiment, during the process of customizing and forming the dental guard for an individual user the impression tray  200  and the dental guard  100  are placed in the wearer&#39;s mouth and the impression tray  200  is shaped and dimensioned so that the lower teeth of the wearer contact the lower surfaces  214   b  of the base member  214  of the first lateral side section  204 , the second lateral side section  206  and the arcuate center section  208 . 
         [0034]    In practice, the storage case  300  while open, with the dental guard  100  and impression tray  200  contained therein, is filled with water to completely cover the dental guard  100  and then the storage case  300  is closed. As will be appreciated based upon the following detailed disclosure of the storage case  300 , it is also possible to fill the storage case  300  with water with the cover member  302  closed over base member  303  by pouring water through the vent apertures (or holes)  304  formed in the cover member  302  until the storage case  300  is filled and the dental guard  100  and impression tray  200  are covered with water. The vents  304  also function to insure the storage case is filled with the correct amount of water as any excess water will simply flow out of the vents  304  when the cover  302  is closed. The base member  303  of storage case  300  also includes a handle section  306  to allow for easy gripping and handling of the storage case  300 . The handle section  306  allows one to grip the storage case  300  without having to come into contact with the camber formed by the cover member  302  and base member  303 . Thus, a user can avoid contact with the heated water contained in the storage case during the dental guard forming process. 
         [0035]    The water filled storage case  300  while closed, with the dental guard  100  and impression tray  200  therein, is placed within a microwave oven until the dental guard  100  is sufficiently softened by the microwave energy for fitting. The microwave energy acts upon the dental guard  100  while the water functions dissipate heat. In accordance with a preferred embodiment of the present invention, the water filled storage case  300  is placed in a conventional household microwave oven and subjected to high energy for 45 to 90 seconds, depending upon the microwave oven used, to soften the dental guard  100  for fitting. The time can vary based on the age and wattage of any particular microwave oven. We have found the range of time can vary between 45 and 90 seconds, however 75 seconds seems to work for most microwave ovens. 
         [0036]    The storage case  300  is removed from the microwave oven by grasping handle section  306  and is briefly flushed with cold or lukewarm water via vent apertures  304  to slightly cool the dental guard  100  and impression tray  200 . In accordance with a preferred embodiment, the storage case  300 , and the dental guard  100  and impression tray  200  maintained therein, are flushed with cold or lukewarm tap water for approximately 3 seconds. 
         [0037]    The user then opens the storage case  300  and removes the impression tray  200  with the dental guard  100  maintained therein. In particular, the user immediately picks up the impression tray  200  with the dental guard  100  still held within the impression tray  200 , and carefully places it in his or her mouth by sliding the dental guard  100 /impression tray  200  backward in his or her mouth until the front teeth contact the exterior upstanding wall member  210  at raised area  222  of the arcuate center section  208  while using alignment notch  225  to center the impression tray  200  between their two front teeth. While looking in a mirror and using alignment notch  225  for a point of reference, or by feel the user aligns the center of the dental guard  100 /impression tray  200  below the two front teeth and the sides of the dental guard below the upper molars. The user then bites down on the dental guard  100  for approximately 1 minute to customize and shape the dental guard  100  to specifically fit the user. The dental guard  100  and the impression tray  200  are then removed from the user&#39;s mouth. Cold tap water is then poured over the dental guard  100  and impression tray  200  for 15 seconds to facilitate the setting of the molded dental guard  100 . The dental guard  100  is then allowed to cool and is then removed from the impression tray  200  and allowed to sit at room temperature for 2 hours after which time the dental guard  100  is ready for use. The impression tray  200  may then be discarded and the storage case  300  used for storing the dental guard  100  when the dental guard  100  is not in use. If the user makes a mistake and needs to reform the dental guard, the impression tray  200  can be used as a mold to attempt to reform the dental guard material back to a pre-molded state. This allows the user to start the process over to correct any fitting mistakes. More particularly, the dental guard  100 , prior to forming in the procedure disclosed above, is U-shaped and includes a first lateral guard section  104  and second lateral guard section  106 , the first and second lateral guard sections  104 ,  106  being connected by an arcuate guard section  108 . Prior to custom forming, the dental guard  100  also includes a smooth upper surface  102  and a smooth lower surface  110 , with an interior side wall  112  and an exterior side wall  114  extending therebetween. During the forming processing the lower surface  110  is in contact with the impression tray  200  and, therefore, remains smooth after the dental guard  100  is custom formed as discussed above. The smooth upper surface  102  is provided with an arcuate alignment groove  116  along the arcuate guard section  108  of the dental guard  100  for engagement with the front teeth of the user so as to enhance alignment of the dental guard  100  during the forming processing. 
         [0038]    As best seen in  FIG. 9 , dental guard  100  includes angled interior and exterior side walls  112 ,  114 . Side wall  112  starts at edge  113  of the upper surface  102  and tapers down and outward to edge  115  of lower surface  110 . Side wall  114  starts at edge  117  of the upper surface  102  and tapers down and outward to edge  119  of lower surface  110 , resulting in the width of upper surface  102  being smaller than the width of lower surface  110 . In cross section the dental guard prior to forming appears as a truncated triangle. This shape results in edges  115 ,  119  of the lower surface  110  of the dental guard  100  snapping into the impression tray  200  such that they are frictionally retained between upstanding side walls  210 ,  212  of the impression tray  200 . The upper edges  113 ,  117  of the upper surface  102  do not contact upstanding side walls  210 ,  212  of the impression tray  200 . Thus, side walls  112 ,  114  only contact upstanding side walls  210 ,  212  of the impression tray  200  approximate lower edges  115 ,  119  resulting in a space between side walls  112 ,  114  of the dental guard and upstanding side walls  210 ,  212  of the impression tray  200 . As such, during the forming process the side walls  112 ,  114  of dental guard  100  can move outward, when bit into, before contacting the upstanding side walls  210 ,  212  of the impression tray  200 . This results in a lower profile finished product which is more comfortable to the user as the dental guard material moves laterally outward before moving upward. That is, the interior and exterior portions of the dental guard  100  which fit about a user&#39;s teeth after forming extend a shorter distance up a user&#39;s teeth and remain well below the gum line. 
         [0039]    In accordance with a preferred embodiment, the dental guard  100  is made from a propylene based elastomer having moderate elastomeric properties. The propylene based elastomer is an olefinic elastomer having an ethylene content of around 11.0% by weight. The elastomer has a melt mass-flow rate (g/10 min.) of 7.0 (230° C./2.16 kg) and does not degrade when subject to microwave radiation, but does become soft and moldable. 
         [0040]    Once formed by the application of force by the teeth of a user, the dental guard  100  includes an upper surface  102  with cavities conforming to the shape and spacing of the user&#39;s upper teeth. In particular, the upper surface  102  is no longer smooth but includes a plurality of recesses registering with and conforming to the teeth of the user. The lower surface  110  and the side walls  112 ,  114  of the dental guard  100  remain substantially smooth as they are supported within the cavity  202  of the impression tray  200  during the forming process. The lower surface  110  becomes hardened and compacted as a result of the user biting down into the dental guard. After the fitting process takes place, this hardened surface is what keeps the user from biting through the tray and grinding his or her teeth during the night while wearing the device. 
         [0041]    As discussed above, the storage case  300  is shaped and dimensioned for storing the dental guard  100  prior to the forming processing, during the forming process, and after the forming process when the dental guard  100  is stored after use on a nightly basis. The storage case  300  includes a closed base  303  defining a cavity  308  in which the dental guard  100  is placed during use. In particular, the closed base  303  includes a plurality of upstanding side walls  310  extending from a perimeter of a base member  314 . The upstanding side walls  310  and the base member  314  define a cavity shaped and dimensioned for receiving the dental guard  100 , as well as the impression tray  200  with the dental guard  100  positioned therein. 
         [0042]    The storage case  300  is further provided with a cover member  302  secured to the closed base  303  via a living hinge connection  316 . The perimeter edge  318  of the cover member  302  is shaped and dimensioned to mate with the upper ends  320  of the side walls  310  when the cover member  302  is brought into engagement with the storage case base  303 . The perimeter edge  318  of the cover member  302  opposite the edge of the cover member  302  with the living hinge  316  is provided with a fastening notch  322  shaped and dimensioned to engage a fastening notch  324  formed along the upper end  320  of the side wall  310 . In this way, the cover member  302  may be secured to the closed base  303  so as to enclose the cavity defined by the closed base  303 . 
         [0043]    While the closed base  303  is formed without holes or other apertures so as to provide a cavity  308  in which water may be contained, the cover member  302  includes a plurality of venting apertures or holes  304  allowing for the venting of water vapor when the system  10  is subjected to microwave energy and heated in accordance with the present invention. Thus, excess pressure in the storage case  300  and over heating of the dental guard is prevented. 
         [0044]    In accordance with a preferred embodiment, the dental guard  100  is impregnated with flavoring, such as mint, that enhances the usability of the dental guard  100 . 
         [0045]    While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.