Abstract:
Improvements in cushioned custom dental guard to be constructed with EVA instead of Polyshok. The molding process ensures that the mouth guard provides even fit on all of the teeth. The custom fit is performed by taking an impression of the upper teeth and gums of the user. The dental guard can then be constructed to ensure a proper custom fit. Each layer provides a different function to provide an ideal cushion, as well as integration of artwork that is visible through the front of the dental guard. The dental guard may include air cells or chambers. The air cells provide a cushion by compressing the air cells to absorb an impact and spread the force of the impact over a greater area. A reinforcing wire maintains the shape and distribute impact forces. The reinforcing wire is completely embedded and encapsulated within the dental guard.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of applicant&#39;s provisional application Ser. No. 61/865,051 filed Aug. 12, 2013 the entire contents of which is hereby expressly incorporated by reference herein. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0004]    Not Applicable 
       BACKGROUND OF THE INVENTION 
     Field of the Invention 
       [0005]    This invention relates to improvements in a dental guard. More particularly, the present reformable dental guard is built-up as a layering process to provide cushioning from impacts that can occur while participating in contact sports. 
         [0006]    Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98. 
         [0007]    Athletes that participate in contact sports, for example football players, boxers and basketball players, are exposed to trauma from facial blows which may cause damage to the individual. Head blows cause motion between the upper and lower jaw that can result in trauma. To reduce the hazards of such facial trauma injuries, protective mouth guards have been developed for use by athletes and others. Protective mouth guards for athletes generally fall into three types. 
         [0008]    All the retail boil and bite mouth guards in the market today are machine made injected molded. Because of this fact, material limitations prevent individuals to achieve a truly secure fitted mouth guard from any boil and bite. 
         [0009]    There is no dispute that wearing a mouth guard is better than not wearing one. A properly fitted mouth guard gives the best protection that an individual can have. Wearing a custom mouth guard moves the jaw downward and forward creates joint space in the TMJ. Regardless of any technology patents filed, this cushioned space may reduce concussive forces to the temporal area. 
         [0010]    The 3 different types of materials used today to manufacture mouth guards are EVA (ethylene vinyl acetate), Polyshok and ProForm. These materials have been vaguely studied over the years and the conclusion has become very debatable as to what is the best material. To date there has been no conclusive data that suggests which material has a higher impact rating. 
         [0011]    The major issue is that no one except Polyshok has done any type of testing. There are two different studies that are published and both have 3 of the same authors. The problem with the studies is that they have the opposite conclusion. The first study states that Polyshok has a superior impact energy absorption rate while the second study states that there is no real difference between EVA, Polyshok, and Proform mouth guard materials. Both studies where performed in the same manner at two different times. 
         [0012]    Problems with using Polyshok material include but are not limited to the Polyshok material quickly breaking down where the longevity of the mouth guard is significantly decreased by half. The cost of the material is triple the amount of EVA material. Polyshok material still requires the use of clear EVA as the final layer as well as the primary layer because PolyShok does not have a clear material. Polyshok cannot be a single layer material because it will not last if it is either used as the primary layer or the final layer. This also means that any testing that was conducted is not conclusive because once you place another layer on top of Polyshok you have changed the impact absorption properties. 
         [0013]    There has been a history of bonding problems between EVA and PolyShok on the last layer where the main issue has been delamination of the two materials. 
         [0014]    A number of patents and or publications have been made to address custom molded mouth guards. Examples of patents and or publication that disclose fabrication of custom molded mouth guards include U.S. Pat. No. 7,882,839 that issued on Feb. 8, 2011 to Edward J. Ambis Jr. that improves the ability of the wearer to speak. 
         [0015]    U.S. Pat. No. 6,837,246 issued on Jan. 4, 2005 to Anthony G. DeLike discloses a mouth guard with an improved tongue-airway passage to improve the ability of the wearer to breath. The construction of this device is homogeneous and is fabricated from a casting of the wearer&#39;s oral cavity. 
         [0016]    U.S. Pat. No. 6,691,710 issued on Feb. 17, 2004 to Jon D. Kittelsen et al for a composite mouth guard. The composite mouth guard is constructed from mechanically interlocking pieces. Because some of the composite materials are rigid the mouth guards are made in a variety of finite sizes to fit different size mouths. The fit is not custom made to fit an individual mouth. 
         [0017]    U.S. Pat. No. 5,879,155 issued on Mar. 9, 1999 to Jon D. Kittelsen discloses an Adjustable Customized Composite Dental Appliance With Wire Band. The wire band connects two separate posterior pads. The wire band simply maintains the position of the two separate posterior pads to prevent the pads from being swallowed. The wire band is not covered and does not provide structural support to the dental appliance. 
         [0018]    What is needed is a dental guard that is custom fabricated to fit the upper teeth of a user with a reinforcing wire to maintain the shape and distribute impact forces. The mouth guard is fabricated using multiple cushioning layers to provide a custom fit of optimal cushioning and improved jaw alignment. The proposed document provides disclosure of such a mouth guard. 
       BRIEF SUMMARY OF THE INVENTION 
       [0019]    It is an object of the reformable dental guard to be constructed with EVA instead of Polyshok. EVA is the industry standard when manufacturing mouth guards and it is a material that has not changed over the past 10 years. EVA material is an unchanging material whether it is heated or boiled, the properties and protection stay the same. When you use the same material throughout the manufacturing process you ensure that delamination rarely occurs 
         [0020]    It is an object of the reformable dental guard for the dental guard to be molded for each individual user. The molding process ensures that the mouth guard provides even fit on all of the teeth. The custom fit is performed by taking an impression of the upper teeth and gums of the user. The dental guard can then be constructed to ensure a proper custom fit. 
         [0021]    It is another object reformable dental guard to be constructed with layers of material. Each layer provides a different function to provide an ideal cushion, as well as integration of artwork that is visible through the front of the dental guard. 
         [0022]    It is another object reformable dental guard to provide air cells or chambers within the dental guard. The air cells provide a cushion by compressing the air cells to absorb an impact and spread the force of the impact over a greater area. 
         [0023]    It is another object reformable dental guard to provide a method of manufacturing a boil and bite mouth guard that can be re-boiled and reshaped to fit a subsequent mouth guard to achieve a fit characteristic that of a custom fitted mouth guard. In order to achieve the closest possible fit to a custom mouth guard, you have to manufacture the boil and bite with the dimensions, average surface area, and thickness comparable to that of a custom mouth guard. This will be the design guideline for the mold for which the boil and bite will be used to manufacture. 
         [0024]    It is another object reformable dental guard to be created similar to a custom mouth guard where an important step deals with the materials used to manufacture custom mouth guards, when melting point is reached it can conform to dental anatomy and during the cool down process, holds its shape more steady than that of injected molded plastic. No boil and bite manufacturer has ever attempted this manufacturing process due to the intensive process and manual labor it takes to make a custom mouth guard. 
         [0025]    It is another object reformable dental guard to utilize a reinforcing wire to maintain the shape and distribute impact forces. The reinforcing wire is spline or sine shaped to protect the distal tips of the front teeth and anchor along the sides of the molars to provide additional protection to the teeth and provide structural shape to the dental guard. 
         [0026]    It is still another object of the reformable dental guard for the dental guard to accept a standard or custom logo. The logo is embedded into the front of the dental guard such that the artwork can be visible through to opponents. 
         [0027]    Various objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention, along with the accompanying drawings in which like numerals represent like components. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0028]      FIG. 1  shows a comparison of the construction of the reformable mouth guard with other manufacturing processes. 
           [0029]      FIG. 2  shows a flow chart of the manufacturing process used to create the reformable dental guard. 
           [0030]      FIG. 3  shows a pictorial view of what occurs when a jaw is struck. 
           [0031]      FIG. 4  shows a partial cross section of the reformable mouth guard in a user. 
           [0032]      FIG. 5  shows a bottom view of the reformable mouth guard on the upper pallet. 
           [0033]      FIG. 6  shows a cross sectional view of the reformable mouth guard from  FIG. 5 . 
           [0034]      FIG. 7A ,  FIG. 7B  and  FIG. 7C  show the shape and position of the hard acrylic and the reinforcing wire in the reusable mouth guard. 
           [0035]      FIG. 8A  and  FIG. 8B  shows an image of the mold that is used to form the reusable mouth guard. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]      FIG. 1  shows a comparison  19  of the construction of the dental guard with other prior art manufacturing processes. The diagrams that are located and referenced throughout this section to help you gain a broader understanding of how the dental custom dental guard differs from boil and bite mouth guard manufacturing companies. 
         [0037]    Many companies start with 4 mm material  21  which does not suck into the interproximal contacts very well which in turn can cause a loose fit. Other companies will typically use a use a second layer that is 2 mm or 3 mm thick material  22  which creates bulky mouth guard on the palate of the athlete. At this point, prior art mouth guards put graphics on top of the already approximately 8 mm thick material of material which reduces down to approximately 4-5 mm of thickness. The prior art makes every dental guard in essentially the exact same way and using the exact same material no matter what size mouth of the user. 
         [0038]    With custom dental guards, after a dental impression has been obtained a thin clear layer of material is used as a base material  31  of between 1 mm and 2 mm. A second layer  32  is combined to the first layer. The second layer is custom hand layering for thickness control and adding hard layer of protection maintaining 100% bondable surface between layers with no added delaminating risk. Within this layer air pockets or cushions can be included for shock dispersion when applicable or desired. The second layer  32  is then heat treated until it is completely smooth and uniform. 
         [0039]    Third Layer  33  is either 2 mm or 3 mm material. This sub assembly of layers has not yet been added to the palate area. The thickness of the material that is used is based on the width of the palatal area of each unique user. The fourth or last layer  34  is clear either 2 mm or 1.5 mm depending on the patient&#39;s mouth. The improvements are not only with the graphic quality, but also with the manufacturing process. 
         [0040]      FIG. 2  shows a flow chart of the manufacturing process used to create the reformable dental guard. First the design mold is placed in the thermoforming unit  80 . An EVA sheet is placed on top of the ring  81 . The heating mechanism is initiated to heat the EVA material  82 . 
         [0041]    Once the EVA material sags to approximately 1″  83  the thermoforming cylinder is lowered  84  to the ring to seal and pressurize the chamber between 70 to 90 psi. When the cooling process is complete, the EVA material is formed on the mold  85 . When cool down process is complete, raise the cylinder and remove EVA sheet from mold  86 . Excess material that forms on the outside of the design mold is cut and trimmed off of the mold  87 . 
         [0042]    The arched sine wire  36  is the placed onto the mouth guard where a hard acrylic layer  35  is added to the guard to bond and retain the arched sine wire. The acrylic layer also increases the structural strength of the mouth guard over the front anterior teeth. 
         [0043]    The material is placed back on the mold and the mold is placed back into the thermoforming unit  89 . 
         [0044]    A second EVA sheet is placed on top of the ring  90 . The heating process is initiate with the heating mechanism to heat the second sheet of EVA material  91 . Once the material sags to touch mold  92 , initiate the thermoforming cylinder to lower towards the ring  93  to seal and pressurize the chamber between 70-90 psi. When cool down process is complete  94 , raise the cylinder and remove the 2 layers of formed EVA sheet from the mold  95 . Any desired graphics or artwork is applied to the mouth guard surface where it is the desired location  88 . For some complex graphics additional layers of EVA may be required between different graphic images. 
         [0045]    Cut and trim the excess material that formed outside of the design mold  96 . Polish the edges so that there are no excess and the edges are rounded and curved. Cutting, trimming, and polishing skillsets are learned in the custom mouth guard arena. Because of the construction of the reusable mouth guard, if the fit is not correct, the mouth guard can be re-boiled and the material will essentially re-flow and allow a person, or a subsequent person to boil and bite the mouth guard to achieve a custom fit mouth guard. The re-heating and bite operation can be repeated numerous times with little or no degradation or compromise in the custom fit. 
         [0046]    To form the reformable dental guard in the mouth of a user reformable dental guard is heated in water between 180 and 212 degrees Fahrenheit and then placed into a mouth on upper teeth of a person whereupon the person closes said mouth and forces said upper teeth into the reformable dental guard for create an initial impression into the reformable dental guard. If the user wants to re-form the dental guard or another user want to use the same dental guard the reformable dental guard is again re-boiled where the dental guard will reflow into its original condition where it can conform into the mouth of the user. 
         [0047]      FIG. 3  shows a pictorial view of what occurs when a jaw is struck, and  FIG. 4  shows a partial cross section of the dental guard in a user. In normal resting mode the mandible  43  is cushioned by the connective tissue  42  to the condyle  41  at the end of the jaw in the socket  40 . When an unprotected athlete receives an impact  18  to the lower jaw or chin. The impact is translated  17  through the jaw or mandible  43  and can cause an impact that can hit the brain thereby causing a concussion. 
         [0048]    The concussion is the result of the mandible  53  being pushed so hard that the connective tissue  52  is squeezed into the condyle  51  and into the socket  50 . From  FIG. 3  the mandible  63  is cushioned by the reformable dental guard  60  that cushions the athletes  16  teeth  61  to increase the frictional forces between the teeth to reduce movement of the mandible  63 . 
         [0049]      FIG. 5  shows a bottom view of another embodiment of the reformable dental guard  60  on the upper pallet. From  FIG. 4  the dental guard is formed from the anterior teeth (incisors and canines)  70  to the posterior teeth (molars and bicuspids)  71 . Optional air cushions  75  are shown placed between adjacent incisors and canines. In this embodiment seven air cushions are shown, but more or less air cushions  75  are contemplated. Locating the air cushions  75  between the teeth is generally placed because extra space exists between the teeth without increasing the thickness of the dental guard. Placement of the cushion(s)  75  is generally not made between posterior teeth  71  because impacts to this area of the mouth are less common. 
         [0050]      FIG. 6  shows a cross sectional view of the dental guard from  FIG. 5 . A thin clear layer of material is used as a base material  31 . A second layer  32  is combined to the first layer. The second layer is custom hand layering for thickness control and adding hard layer of protection maintaining 100% bondable surface between layers with no added delaminating risk. Within this layer air pockets or cushions  75  can be included for shock dispersion when applicable or desired. The second layer  32  is then heat treated until it is completely smooth and uniform. Third Layer  33  is either 2 mm or 3 mm material. This sub assembly of layers has not yet been added to the palate area. The thickness of the material that is used is based on the width of the palatal area of each unique user. The fourth or last layer  34  is clear either 2 mm or 1.5 mm depending on the patient&#39;s mouth. 
         [0051]    Controlling the thickness of the dental guard is critical to providing comfort and protection. There has been limited published articles on testing that has been performed on mouth guards after a mouth guard has been manufactured. Even the surface area being tested only gives the best representation of the type of impact and simulation as an estimate to the protection. 
         [0052]      FIG. 7A ,  FIG. 7B  and  FIG. 7C  show the shape and position of the hard acrylic  38  and the reinforcing wire  39  in the reusable mouth guard. The dental guard is formed from the anterior teeth (incisors and canines)  70  to the posterior teeth (molars and bicuspids)  71 . Optional air cushions  75  are shown placed between adjacent incisors and canines. The reinforcing wire  39  is formed in as a spline or sine wave. The reinforcing wire  39  maintains the shape and distribute impact forces. The reinforcing wire is completely embedded and encapsulated within the dental guard. Additional location of the hard acrylic can be placed along the length of the wire and at the ends of the wire depending upon the nature of the sport, user teeth grinding and other factors. 
         [0053]    The reinforcing wire  39  is spline or sine shaped to protect the distal tips of the anterior teeth (incisors and canines)  70  and arches to the posterior teeth (molars and bicuspids)  71  to provide additional protection to the teeth and provide structural shape to the dental guard. At the sides of the dental guard the reinforcing wire arches near the gum line to increase the vertical displacement of the wire to improve retention of the reinforcing wire within the dental guard to reduce a potential of the wire from being “stripped” from the dental guard. It is also contemplated that the reinforcing wire can be knurled or otherwise surface treated to increase retention of the reinforcing wire  39  within the dental guard. 
         [0054]      FIG. 8A  shows an inside perspective view of the mold used to make the reformable dental guard, and  FIG. 8B  shows a bottom perspective view of the reformable dental guard. The bottom  100  of the mold is where the mold sits flat within the thermoforming unit. The sheets of EVA material are placed on the top surface of the mold as might be seen in  FIG. 7A . From this top perspective view  7 A the mold has a raised outer ridge  103  that forms the general profile where teeth would exist in the mouth of the athlete. A lowered area  104  in the front of the mold provides some clearance between the front teeth. A clearance area  105  in the center of the mold provides clearance for the tongue of the athlete. A ridge  101  and  102  forms the trim area for the gums of an athlete. The vertical wall  106  provides a clearance for the teeth of an athlete. 
         [0055]    Thus, specific embodiments of a cushioned reformable dental guard have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.