Patent Document

BACKGROUND OF THE INVENTION  
         [0001]    This invention generally relates to a performance enhancing and force absorbing composite mouthguard for use by athletes, and more particularly to such an adjustable customizable tethered mouthguard appliance that spaces apart the teeth to absorb shock and clenching stress to protect the anterior and posterior teeth of the upper jaw, to lessen condyle pressure, force and impact upon the cartlidge and temporomandibular joints, the arteries and the nerves and to further increase body muscular strength and endurance.  
           [0002]    A number of mouthguards currently exist in the art for protecting the teeth and for reducing the chance of shock, concussions and other injuries as a result of high impact collisions and blows during athletic competition. Mouthguards generally are characterized as being non-personalized, universal and stock model type, or are formed to have direct upper jaw tooth-formed contact. These are customizable mouthguards.  
           [0003]    Additionally, the mouthguards may be tethered or untethered. Mouthguards may be tethered to a fastening point, such as a helmet or face guard, to prevent the chance of the mouthguard from being lost as well as to prevent swallowing of the mouthguard or choking on the mouthguard by the user. However, tethers should be releasable in case the helmet is dislodged from the head to avoid further injury. Most tethers are cumbersome and are a visual obstruction in front of the face of the wearer.  
           [0004]    The lack of a mouthguard or the use of an improperly fitted mouthguard, when impacts, collisions or blows occur to the jaw structure of an athlete, have recently been found to be responsible for illnesses or injuries. Such injured athletes are susceptible to headaches, presence of earaches, ringing in the ears, clogged ears, vertigo, concussions and dizziness. The cause of these types of health problems and injuries are generally not visible by inspection of the mouth or the jaw but more particularly relate to the temporomandibular joint (TMJ) and surrounded tissues where the lower jaw is connected to the skull in the proximity where the auriculotemporalis nerves and supra-temporo arteries pass from the neck into the skull to the brain.  
           [0005]    In addition to protection of the teeth and the TMJ, athletes clench their teeth during exertion which results in hundreds of pounds of compressed force exerted from the lower jaw onto the upper jaw. Such clenching can result in headaches, muscle spasms, damage to teeth, injury to the TMJ and pain in the jaw. Furthermore, clenching of the teeth makes breathing more difficult during physical exercise and endurance when breathing is most important.  
           [0006]    Most importantly, many problems exist with prior mouthguards. Mouthguards with rigid labial or buccal walls do accept wide teeth, were bulky and had sharp edges. When the custom appliances were placed in hot water to soften for fitting, the mouthguards tended to collapse and permit portions to touch and stick together upon removal from the hot water thus making fitting of such mouthguards always a problem. Delamination and chewing destruction caused short life of the mouthguards.  
           [0007]    There is a need for a mouthguard that solves all of the problems disclosed and will further achieve improved performance and long life as well as being easy to fit and wear for the athlete.  
         SUMMARY OF THE INVENTION  
         [0008]    A performance enhancing and force absorbing mouthguard adapted to fit the upper teeth of the mouth of an athlete wherein the mouthguard is unobstructably tethered and of a composite material. The first internal layer is a nonsoftenable flexible framework which will permit the mouthguard to hold its shape during fitting as well as to absorb and dissipate significant impact conveyed to the upper teeth. A hard, durable bite plate wedge lowers the condyle from the temporomandibular joint in a fulcrum action to place the lower jaw in an optimum condition preventing impingement upon the nerves and arteries as well as spacing the upper and lower teeth apart. Elastomeric traction pads are on the bottom of the mouthguard and are grippingly engaged by the posterior teeth of the lower jaw. While the framework, wedge and traction pads are mechanically interlocked, a softenable material is placed over the mouthguard excepting the contact portions of the traction pads to encapsulate the mouthguard and to permit custom fitting. An anterior tab supports a transverse external bumper having left and right ports to unobstructively tether the mouthguard.  
           [0009]    The principle object and advantage of the present invention is that the mouthguard is that it protects the teeth, jaw, gums, connective tissues, back, head and muscles from concussive impact or blows to the jaw or teeth typically occurring during athletic activity.  
           [0010]    Another object and advantage of the present invention is that the materials are substantially mechanically interlocked as well as encapsulated thereby preventing the possibility of delamination or separation of the materials which otherwise may occur during chewing of the mouthguard by the wearer.  
           [0011]    Another object and advantage of the present invention is that the mouthguard places the lower jaw in the power position moving the condyle downwardly and forwardly away from the nerves and arteries within the fossia or socket to raise body muscular strength, greater endurance, improved performance by the mouthguard user as well as offer protection against concussive impacts.  
           [0012]    Another object and advantage of the present invention is that the mouthguard is customizable to fit the width and configurations of the upper posterior teeth and palate structure of any user. That is, the mouthguard permits customizable fitting, including twisting, contraction and expansion, to permit the various tooth widths, spacing from one side of the mouth to the other side of the mouth, and palate height which also vary substantially from person to person.  
           [0013]    Another object and advantage of the present invention is that it has a tough, rubbery elastomeric, unpenetrable bottom layer or traction pad which engages and grips the posterior teeth of the lower jaw and which further prevents the appliance from being chewed through to thereby assure long life to the appliance.  
           [0014]    Another object and advantage of the present invention is that the framework of a non-softenable flexible material supports the appliance after heating to maintain shape and to guide the upper teeth during the fitting process.  
           [0015]    Another object and advantage of the present invention is that the hard durable bite plate wedge is of a hard very durable material that acts as a bite plate wedge or fulcrum that cannot the be penetrated by teeth thereby giving the appliance a longer life cycle.  
           [0016]    Another object and advantage of the present invention is that the labial and lingual walls are not rigid allowing the user to manipulate the softenable material and to custom fabricate the mouthguard to accommodate proper fitting and to achieve more comfortable and less intrusive presence in the wearers mouth.  
           [0017]    Another object and advantage of the present invention is that an anti-microbial ingredient keeps the appliance free of germs, fungus, virus, yeast and bacteria and also may treat gum disease.  
           [0018]    Another object and advantage of the present invention is an internal protective elastomeric bumper extending anteriorly from the traction pads for protecting the anterior teeth.  
           [0019]    Another object and advantage of the present invention is the external protective elastomeric bumper which protects the mouth.  
           [0020]    Another object and advantage of the present invention is the left and right tether anchor ports which unobstructively permit tethering the mouthguard from either the left or right side according to wearer preference as mouthguards are often removed and reinserted during athletic activity.  
           [0021]    Another object and advantage of the present invention is that the external bumper is suitable for bearing an artistic logo.  
           [0022]    Another object and advantage of the present invention is that the logo, tether or remote anchor may be illuminated.  
           [0023]    Another object and advantage of the present invention is that the tethered mouthguard may be remotely anchored in a variety of ways. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0024]    [0024]FIG. 1 is a maxillary mandibular buccal or partial side elevational view of the jaws and temporomandibular joint of the user of the mouthguard of the present invention.  
         [0025]    [0025]FIG. 1A is an enlarged view of the temporomandibular joint portion of FIG. 1.  
         [0026]    [0026]FIG. 2 is an exploded view of the composite tethered mouthguard.  
         [0027]    [0027]FIG. 3 is a side elevational view partially broken away of the mouthguard showing the wedge being thicker posteriorly than anteriorly.  
         [0028]    [0028]FIG. 4 is a side elevational view partially broken away similar to FIG. 3 with the wedge being thicker anteriorly than posteriorly.  
         [0029]    [0029]FIG. 5 is a perspective view of the mouthguard bearing a logo with the tether about to be inserted into the left port.  
         [0030]    [0030]FIG. 6 is a top plan view of the mouthguard and tether connected partially broken away.  
         [0031]    [0031]FIG. 7 is an enlarged partially broken away view of the tethered mouthguard with the tether connected taken along lines  6 - 6  of FIG. 6.  
         [0032]    [0032]FIG. 8 is an environmental view of the tethered mouthguard wherein the tether is anchored to a chin strap buckle snap.  
         [0033]    [0033]FIG. 9 is a side elevational view of the tethered mouthguard secured to a face screen or shield of a helmet by adhesive particularly shown in explosion within the phantom circle.  
         [0034]    [0034]FIG. 10 shows the face mask tether clamp anchor fastened to a face mask of a football helmet.  
         [0035]    [0035]FIG. 11 shows the face mask tether cinch anchor connected to a face mask of a football helmet.  
         [0036]    [0036]FIG. 12 shows a perspective view of the illuminated mouthguard tether and anchor.  
         [0037]    [0037]FIG. 13 shows the schematics of the illumination of FIG. 12. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0038]    To understand the structural features and benefits of the dental appliance or mouthguard  70  of the present invention, some anatomy will first be described. Referring to FIGS. 1 and 1A, the user or athlete has a mouth  10  generally comprised of a rigid upper jaw  12  and a movable lower jaw  42  which are movably connected at the temporomandibular joint (TMJ)  32  and  50 .  
         [0039]    More specifically, the rigid upper jaw  12  has gum tissue  14  within mouth  10 . Gum tissue  14 , as well as the bone thereunder, supports anterior teeth (incisors and canines)  18  which have incisal or biting surfaces  19 . The gum tissues  14  and the bone thereunder also support posterior teeth (molars and bicuspids)  22  which have cusps or biting surfaces  26 .  
         [0040]    Referring to one side of the human head, the temporal bone  28  is located upwardly and rearwardly of the upper jaw  12  and is in the range of {fraction (1/16)} th  to {fraction (1/32)} nd  inch thick. The articular eminence  30  forms the beginning of the fossae  32  or the socket of the temporomandibular joint  32  and  50 .  
         [0041]    Rearwardly and posteriorly to the articular eminence  30  is located cartilage  34 . Through the temporomandibular joint  32  and  50  pass the ariculo-temporalis nerve  36  and supra-temporo artery  38 . Posteriorly to this structure is located the inner ear  40 . Within the mouth is located tongue  39  and the roof or hard palate  41 , which terminates rearwardly into the soft palate and forwardly into the anterior palate or ruggae  43 . The ruggae  43  has a rib surface which is identifiable by the fingers or tongue  39 . The tongue touches the ruggae  43  during speech.  
         [0042]    The movable jaw or mandible  42  supports a bone covered by gum tissue  44  which further supports anterior teeth (incisors and canines)  46  with incisal or biting surfaces  47  and posterior teeth (molars and bicuspids)  48  with occlusal biting surfaces  49 . The condyle  50  of the lower jaw  42  forms the ball of the temporormandibular joint  32  and  50 . The anatomical structure is the same for both sides of the head.  
         [0043]    Repeated impacts, collisions, blows, stress or forces exerted on the movable lower jaw  42  results in excessive wearing forced upon the condyle  50  and the cartilage, meniscus, or disc  34 —typically resulting in bone deterioration on the head of the condyle or slippage and compressive damage of the cartilage  34 . Thereafter, the lower jaw  42  may be subject to irregular movement, pain, loss of comfortable range of movement, and clicking of the joint  32  and  50 .  
         [0044]    The ariculo-temporatis nerve  36  relates to both sensory and motor activity of the body. Any impingement or pinching of this nerve  36  can result in health problems as previously mentioned. This supra-temporal artery  38  is important in that it provides blood circulation to portions of the head. Impingement, pinching, rupture or blockage of this artery  38  will result in possible loss of consciousness and reduced physical ability and endurance due to the restriction of blood flow to portions of the brain. Thus, it is extremely important to assure that the condyle  50  does not impinge upon the ariculo-temporalis nerve  36  or the supra-temporal artery  38 . It is also important to note that the temporal bone  28  is not too thick in the area of the glenoid fossae. Medical science has shown that a sharp shock, stress or concussive force applied to the lower jaw  42  possibly could result in the condyle  50  pertruding through the glenoid fossae of the temporal bone  28  thereby causing death. This is a suture line (growth and development seam) in the glenoid fossae, resulting in a possible weakness in the fossae in many humans. This incident rarely, but sometimes, occurs with respect to boxing athletes.  
         [0045]    The mouthguard of the present invention is shown in the Figures as reference number  70 .  
         [0046]    Mouthguard  70  is generally u-shaped and is comprised of labial wall  72 , lingual wall  74 , which are upstanding from base  76 , and channel  78  is formed by this arrangement.  
         [0047]    Specifically referring to FIGS. 2-4, the mouthguard  70  generally comprises three layers of distinct materials  86 ,  114  and  136 . The framework  86  is of a non-softenable, flexible material to assist in maintaining the shape of the heated mouthguard  70  and to permit the sizing of the mouthguard by way of twisting, expansion and contraction for variously configured mouths. The bite plate wedge  92  is part of the framework and permits displacement of the condyle and proper positioning of the lower jaw  42 . The traction pads  114  are elastomeric and therefore rubbery and grippable. The anterior impact brace or internal protective bumper  122  extends from the traction pads  114  while the external protective bumper  126  extends from the internal protective bumper  122 . The encapsulating material  136  is softenable and forms walls  72  and  74  and channel  78 . This portion of the mouthguard  70  softens when heated and permits custom fitting of the mouthguard  70  in a particular mouth configuration.  
         [0048]    The first shot of the mouthguard  70  is comprised of the non-softenable, flexible framework  86  which is suitably made of high-density polyethylene which exhibits a rigid character in that it holds its shape and can handle hot water because its melting point is 270° Farenheit. The material also has excellent bonding qualities with other copolymers and is FDA compliant. The polyethylene part number appropriate for the framework  86  is HD-6706 from ExxonMobil Chemical Company, P.O. Box  3272 , Houston, Tex. 77253-3272.  
         [0049]    The framework  86  suitably may have a connecting Belvedere bridge  88  which spans across the anterior portion of the labial wall  72 . The bridge  88  then connects to Cross-cantilever connectors  90  which connect to the occlusal pad plates or wedges  92  in various places to assure the relative stability of the framework  86 . The occlusal pad plates  92  shown in FIG. 3 are shown to be thicker posteriorly than anteriorly. The pad plates or wedges  93  in FIG. 4 are shown to be thicker anteriorly than posteriorly. The particular choice of plates or wedges  92  or  93  are dependent upon the physiology of the wearer of the mouthguard  70  suitably determined by medical assistance. The plates or wedges  92  have index openings  94  therethrough.  
         [0050]    The next injection molding shot is that of traction pads  114 , internal protective bumper  122 , protruding tab  124 , and external protective bumper  126 . The traction pads  114  contact and grip the occlusal biting surfaces  49  of the posterior teeth  48  of the lower jaw and must be composed of a durable, resilient material which deforms somewhat when the jaws are closed and cushion teeth  48  of the lower jaw  42 .  
         [0051]    The durable resilient material of this layer or second shot comprises a thermoplastic elastomer. The material may be Dynaflex®, Part No. G2780-0001 from GLS Corporation, 833 Ridgeview Drive, McHenry, Ill. 60050. This material is suitable in that the teeth can interdigitate on the pads  114  and the material is chemically and bondably compatible, as well as being FDA compliant and approved for mouthguards.  
         [0052]    The traction pads  114  have projecting interlocking knob or projections  116  which resemble a Christmas tree. The bucket lip or retaining lid  120  and interlocking knobs  116  assure that the pads  114  are interlocked with the bite plate wedges  92 . Forward of the traction pads  114  extend an anterior impact brace or internal protective elastomeric bumper  122  from which extends protruding tab  124  in an anterior fashion. A transverse external protective elastomeric bumper  126  is connected to tab  124  as they are all integrally molded.  
         [0053]    Connectors for the tethers may be left port  128  or right port  130 . Because the tether is meant to be securely and permanently fastened, nylon inserts  132  with an annular locking rib  134  are placed in the mold for their interlocking position within the external protective bumper  126  shown in detailed cross section in FIG. 7. The external bumper  126  also suitably supports an artistic logo  135 . The nylon material suitably may be part number N6650L from Michael Day Enterprises, 960 Seville Road, Wadsworth, Ohio 44281. The nylon material does not begin to melt until approximately 500° Farenheit.  
         [0054]    The durable resilient material of the traction pads  114  and bumpers  122  and  126  may include in another embodiment a styrene block copolymer and ethylene vinyl acetate (EVA). EVA is available from a number of sources, such as ELVAX® Resins from Dupont Packaging and Industrial Polymers, 1007 Market Street, Wilmington, Del. 19398. It is desirable that the durable resilient material have a Shore “A” hardness of approximately 82, which is very durable, yet rubbery.  
         [0055]    In another embodiment, the traction pads may have the styrene block copolymer mixed with polyolefin elastomer, which is a copolymer of ethylene and octene-1. A suitable copolymer is available under the trademark ENGAGE® from Dupont Canada, Inc., P.O. Box 2200, Streetsville, Mississauga, Ontario L5M 2H3.  
         [0056]    Another embodiment of the pads and bumpers may be a mixture of thermoplastic rubber and a polyolefin elastomer as described above. Suitably thermoplastic rubbers are SANTOPRENE® from Advanced Elastomer Systems, L.P., 388 South Main Street, Akron, Ohio 44311 and KRATON® thermoplastic rubber from Shell Oil Company, Houston, Tex. KRATON® is composed of a styrene-ethylene-butylene-styrene block copolymer and other ingredients. The exact composition of SANTOPRENE® is a trade secret.  
         [0057]    The third shot of the mouthguard  70  comprises an encapsulation material  136  which is suitably softenable and forms the walls  70  and  74  and channel  78 , as well as base  76  of the mouthguard  70 . Thus, the softenable material does not encapsulate the traction pads  114  or bumpers  122  and  126 , but does encapsulate the entire framework  86 .  
         [0058]    The softenable outer fitting material  136  suitably comprises a mixture of EXACT®, which is a plastomer, Part No. 4023 from ExxonMobil Chemical Company, P.O. Box 3272, Houston, Tex. 77253-3272. The EXACT® material is suitably blended 3:1 with a hydrocarbon resin called REGALREZ®, Part No. 1128 from Eastman Chemical Company, 200 South Wilcox, Kingsport, Tenn. 37660. These materials exhibit low melting points, good density and chemically and bondably compatible with other materials, as well as being FDA compliant for mouthguards.  
         [0059]    Another combination of the softenable material  136  suitably comprises a mixture of EVA and polycaprolactone. A suitable polycaprolactone is TONE®, Part No. Polymer P-767 from Union Carbide Corporation, 39 Old Ridgebury Road, Danbury, Conn. 06817-0001. The softenable material may consist of polycaprolactone alone as the possibility of ethylene vinyl acetate alone may be utilized.  
         [0060]    Another embodiment of the softenable outer material  136  may be a mixture of polycaprolactone and polyolefin elastomer. Preferably, the polyolefin elastomer is a copolymer of ethylene and octene-1. A suitable copolymer is available as ENGAGE® from Dupont Canada, Inc., P.O. Box 2200, Streetsville, Mississauga, Ontario L5M 2H3.  
         [0061]    It is well known that illnesses, infection, tooth decay and/or periodontal disease is caused by bacteria, fungus, yeast and viruses. These microbials can grow and multiply on dental appliances when the appliances are being stored between uses, as well as when the appliance is being worn or used. An antimicrobial substance such as ANGION® from Angion Technologies LLC, 60 Autobon Road, Wakefield, Mass. 01880 may be blended with the framework  86 , traction pads  114  and bumpers  122  and  126 , along with the softenable material  136 . Other antimicrobial substances which are non-toxic and free of heavy metal for resisting the growth of microbials may include chlorinated phenol (e.g. 5-CHLORO-2-(2,-4-DICHLOROPHENOXY)PHENOL), POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE (PHMB), DOXYCYCLINE, HLORHEXIDINE, METRONIDAZOLE, THYMOL, EUCALYPOL and METHYL SALYCILATE. TRICLOSAN® from Siba Giegy of Switzerland is also available.  
         [0062]    Mouthguard  70  incorporating the antimicrobial agent during the manufacture of the mouthguard is achieved by incorporating the agent into the synthetic polymer master batch. The antimicrobial agent is suitably placed into the batch in a concentration as high as 10% which will permit a let-down ratio resulting in final concentration of the antimicrobial agent and the dental appliance of about 0.005 to about 2% by weight. The antimicrobial agent will survive molten temperatures of approximately 350° Farenheit and thus the antimicrobial agent loses none of its biocidal properties in the formation of the mouthguard.  
         [0063]    To fit the mouthguard  70  to the user&#39;s mouth, the mouthguard is placed in hot water at 211° Farenheit (i.e. water that has been brought to a boil and taken off the heat) for about fifteen seconds. The mouthguard is then removed from hot water, and it will be very soft, but the framework  86  will hold the mouthguard in its general shape. Excess water is allowed to drain off the mouthguard  70  by holding it with a spoon or a fitting tool.  
         [0064]    Next, the wearer carefully places the mouthguard in the mouth so that the interior portion of the appliance  70  touches and covers the eye teeth and extends backwards towards the molars. Next, the wearer bites down firmly on the appliance and pushes the tongue against the roof of the mouth. The Cross-cantilever connectors guide the upper molars  22  in position on plates  92 . With a strong sucking motion, the wearer draws out all of the air and water from the mouthguard  70 . The projections or knobs  116  of the traction pads  114  will index to the cusps  26  of the molars  22 .  
         [0065]    With the thumb, the wearer presses the bridge  88  and lingual wall  74  tight against the mouth and then uses his hands and figures to press the outside of the cheeks against the appliance as the labial wall  72  moves to custom form the lingual and buccal or labial walls  72  and  74 , respectively. Because there are no rigid lingual or labial walls in the appliance  70 , the mouthguard  70  will fit any width of molar  22  or mouth.  
         [0066]    The wearer retains the mouthguard in the mouth for at least one minute and, with the mouthguard still in the mouth, takes a drink of cold water. Next, the wearer removes the mouthguard from the mouth and places it in cold water for about thirty seconds.  
         [0067]    Next, referring to the tether  150  and anchor various arrangements, FIGS. 5 through 13 should be considered. Tether  150  suitably may include an internal wire  152  with a plastic  154  outer casing. The ends of the tether  150  may have over-molded connectors  156  with a locking plug  158  and a lip  160  suitably of a Christmas tree design. The locking plug  158  will almost permanently lock with the nylon insert  132  and its locking rib  134 , as shown in FIG. 7. Attempts to remove the tether from either the left or right ports  128  or  130  will likely result in some destruction of the tether or external protective bumper  126 . The over-molded connector  156  suitably may be made of a thermoplastic polyurethane elastomer (polyether) marketed under the name PELLETHANE®, Part No. 2363-55D, by Ashland Distribution Company, 5200 Blazer Parkway, Dublin, Ohio 43017. This material must be rigid and durable to secure to connection ports  128  and  130  in a permanent fashion once the user determines whether tethering should be on the left or right side of mouthguard  70 .  
         [0068]    Football helmet  162  is shown in FIG. 8 having a face mask  164  and chin strap catches, fasteners or male snap connectors or buckles  166 . Face mask tether snap anchor  170  suitably secures to the buckle snaps  166  and has a port  172  with an internal annular locking rib  174 .  
         [0069]    The catch or buckle snap  176  may be utilized for helmets that do not have buckles  166  therein, such as a hockey helmet face shield  180 . Catch  176  is secured to the face shield  180  with double-sided adhesive tape  178  shown in FIG. 9.  
         [0070]    In another embodiment, face mask tether clamp anchor  182  is shown in FIG. 10 suitably having a port  184  with an annular locking rib internally to receive the over-molded connectors  156  of tether  150 . Face mask tether cinch anchor  190  is another variation shown in FIG. 11 having a port  192  with an internal annular locking rib. Anchors  170 ,  182  and  190  are suitably made of thermoplastic resin or ethylene/methacrylic acid copolymer such as SURLYN® 8150 from Dupont.  
         [0071]    Referring to FIGS. 12 and 13, the lighted mouthguard tether and anchor assembly  200  is shown. The face mask tether snap anchor  202  has a logo lens  204  therein with a light  206  or suitably an LED there below. A battery  208  sits within door switch  210  much like a hearing aid. Upon closing the door switch  210 , the circuit is closed and the LED lights the logo lens  204 . Tether  212  may have internal fiberoptics  214  which will carry the light to the mouthguard logo lens  216  in the external bumper  126 .  
         [0072]    The present invention may be embodied in other specific forms without departing from the spirit or central attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.

Technology Category: 1