Abstract:
A one-piece customizable dental appliance for the mouth of an athlete is comprised of an occlusal posterior pad for each side of the posterior teeth engageable with the occlusal surfaces to space apart the teeth and to absorb shock and clenching stress. A band is provided connecting the posterior pads together within the mouth and out of the way of the tongue to maintain the position of the occlusal posterior pads within the mouth during use and to prevent loss of the pads such as by swallowing. Portions of the pads are scored so that they may be easily cut away to customize the appliance for smaller mouths.

Description:
This application is a continuation-in-part of co-owned patent application Ser. No. 08/689,253, filed on Aug. 5, 1996 for an ADJUSTABLE CUSTOMIZED DENTAL APPLIANCE. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates generally to a one-piece customizable dental appliance for use by athletes and, more particularly, to an appliance that spaces apart the teeth to absorb shock and clenching stress, to space apart the anterior teeth of the lower and upper jaws to facilitate breathing and speech, to lessen condylar pressure, force and impact upon the cartiage and temporomandibular joints, the arteries and the nerves, and to further increase body muscular strength and endurance. 
     Almost all athletes such as body builders, weight lifters, baseball batters, golfers, football players, hockey players and bowlers clench their teeth during exertion which results in hundreds of pounds of compressed force exerted from the lower jaw onto the upper jaw. This clenching force is unevenly transmitted through the jaw structure into the connective tissues and muscles of the lower jaw and further into the neck and back. This can result in headaches, muscle spasms, damage to teeth, injury to the temporomandibular joint, and pain in the jaw. Furthermore, clenching the teeth makes breathing more difficult during physical exercise and endurance when breathing is most important. 
     The glenoid fossa located directly ventral to the external auditory meatus is the hollow receptacle for the mandibular condyle or condylar process. 
     The articulation of the condyle in the glenoid fossa is a pure hinge activity around a horizontal axis through the initial 4-10 mm of the opening of the human mouth. After this initial pure hinging function, the continued opening of the mouth becomes a transitory action of the condyle moving forward or ventrally in the glenoid fossa as the continued opening of the mouth is accomplished by the mandible moving in a forward or ventral position. This action of the temporo-mandibular joint (TMJ) is unique in mammals, and is the start of aberrations in the human TMJ. 
     If through trauma, pathology, or habit, the articular surface of the condyle has been altered in its ideal anatomic form, and/or the meniscus is damaged or perforated, an arthritic condition can result, which damages the articular surfaces and associated cartilageanous tissues which lubricate and cushion these two bones, the fossa and the condyle. 
     When the individual attempts to utilize the supportive musculature and skeletal components of the body during strength utilization, or in a stress situation, the muscles of mastication contract in response to this increased stress, and clench the dentition or teeth to such a degree as to compress the structures of the TMJ. 
     The position of the major muscles of mastication, the masseter and the temporals, pull the mandible up and dorsally or back, so that the condyle is driven into the glenoid fossa to a greater degree than in any other situation, and against these altered structures. 
     In an absolutely ideal anatomic situation where the structures of the TMJ have not been altered, this clenching will have minimal effect on the utilization of the human body&#39;s skeletal muscles. 
     Since the negative effects of changes in the TMJ are not known without extensive radiographic, magnetic resonance investigation, and/or surgical analysis, a great percentage of the population will experience a limiting effect by the autonomic nervous system, that system which regulates the stress evaluation by the brain, to limit the clenching action of the jaws. 
     By placing an appliance of a non-yielding material between the posterior teeth, which will open the mouth from 1 to 5 mm by preventing the mandible from being pulled into the condylar-fossa pressure position, the clenching action of the jaws will not over-burden the TMJ or drive the condyle into the glenoid fossa, until this over-burden causes the brain to direct the skeletal muscles to limit their utilization. 
     Furthermore, there is a suture line in the dome of all human glenoid fossae which may be the major component limiting the result of the clenching in the TMJ. As certain individuals clench in increased strength and/or stress activities, this pressure on the glenoid fossa dome can cause edema to result. If an individual partaking in a physical activity sustains a traumatic insult to the TMJ, and an edematous condition results, the balance centers of the skull can be affected and the strength potential will be reduced unless the clenching activity is controlled to prevent the compression of the condyle in the fossa. 
     There is a condition called bruxism which is an unknown causation, idiopathic movement of the mandible, resulting in grinding of the teeth. This condition is particularly troublesome during sleep, because during sleep the muscles of the jaw contract more than while the person is awake and this can cause physical and physiological damage to the masticating apparatus (bone, teeth, muscles, and soft tissues). This damage may cause the capsular system around the TMJ to shrink so that the person cannot open the jaws. An appliance may be inserted in the mouth to prevent bruxism, but where the condition has progressed to the point where the jaws can only be slightly opened, the appliance must be insertable into the mouth through this narrow opening. 
     It has also been found that a dental appliance which allows the wearer to clench the teeth can contribute to the alleviation of stress. Such a device may also be a rehabilitation of recovery aid after general surgery by reducing levels of bodily stress. Finally, a clenching device may have use as a birthing aid for women. 
     There is a need for a simple one-piece customizable dental appliance for the mouth of an athlete which will absorb shock and clenching stress otherwise transferred from the connective tissues, the muscles and lower jaw to the upper jaw, neck and back, will space apart the anterior teeth of the lower jaw from the anterior teeth of the upper jaw to facilitate breathing and speech, and will lessen condylar pressure, force and impact upon the cartilage, and temporomandibular joints, arteries and the nerves. 
     Also, it is desirable that the dental appliance can be manufactured in one size and easily adjusted and customized to the mouths of almost all wearers, from a child to an adult. 
     SUMMARY OF THE INVENTION 
     A one-piece customizable dental appliance for the mouth of an athlete is comprised of an occlusal posterior pad for each side of the posterior teeth engageable with the occlusal surfaces to space apart the teeth and to absorb shock and clenching stress. A band is provided connecting the posterior pads together within the mouth and out of the way of the tongue to maintain the position of the occlusal posterior pads within the mouth during use and to prevent loss of the pads such as by swallowing. Portions of the pads are scored so that they may be easily cut away to customize the appliance for smaller mouths. 
     A principal object and advantage of the present invention is that the one-piece appliance is simple to mold and protects the teeth, jaws, gums, connective tissues, back, head and muscles from teeth clenching forces typically exerted during athletic activity. 
     Another principal object and advantage of the present invention is that it is adjustable or customizable to fit the mouth of almost all wearers while at the same time being securely retained by the anterior teeth and posterior teeth. 
     Another object and advantage of the present invention is that it facilitates breathing and speech during strenuous physical activity such as in power lifting or body building. 
     Another object and advantage of the present invention is that the appliance places the lower jaw in the power position moving the condyle downwardly and forwardly away from the nerves and arteries within the fossae or socket to increase body muscular strength, greater endurance, and improved performance by the appliance user. 
     Other objects and advantages will become obvious with the reading of the following specification and appended claims with a review of the Figures. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a maxillary mandibular buccal or partial side elevational view of the jaws and temporomandibular joint of a user of a dental appliance of the present invention. 
     FIG. 1A is an enlarged view of the circled temporomandibular joint portion of FIG.  1 . 
     FIG. 1B is a top view of the lower jaw, partially broken away. 
     FIG. 2 is a top view of a sizing strip with a dentition imprint. 
     FIG. 3 is a top view of an alternative sizing medium with a dentition imprint. 
     FIG. 4 is a perspective view of the dental appliance of the present invention, partially broken away to show internal structure. 
     FIG. 5 is a cross section along the lines  5 — 5  of FIG.  4 . 
     FIG. 6 is a top plan view of one embodiment of the dental appliance of the present invention with alternative positioning shown in phantom. 
     FIG. 7 is a top plan view of a sizing medium and dentition imprint with one embodiment of the dental appliance of the present invention overlaid thereon. 
     FIG. 8 is a side elevational view of the jaws of the user with structure broken away to show one embodiment of the dental appliance of the present invention being fitted to the mouth. 
     FIG. 8A is a close-up view of one embodiment of the dental appliance of the present invention being fitted to the lower teeth, with alternative positioning shown in phantom. 
     FIG. 9 is a bottom plan view of the dental appliance of the present invention with moldable material inserted in the channel. 
     FIG. 10 is a cross section along the lines  10 — 10  of FIG.  9 . 
     FIG. 11 is a side elevational view of the jaws of the user with structure broken away to show the dental appliance of the present invention being finally fitted to the mouth. 
     FIG. 12 is a bottom plan view of the dental appliance of the present invention with dentition imprints from the lower teeth. 
     FIG. 13 is a rear perspective view of the dental appliance of the present invention. 
     FIG. 14 is a perspective view of the one-piece customizable dental appliance of the present invention. 
     FIG. 15 is a front elevational view of the one-piece dental appliance. 
     FIG. 16 is a rear elevational view of the one-piece dental appliance. 
     FIG. 17 is a right side elevational view of the one-piece dental appliance. 
     FIG. 18 is a cross sectional view taken along lines  18 — 18  of FIG.  15 . 
     FIG. 19 is a left side elevational view of the one-piece dental appliance. 
     FIG. 20 is a cross sectional view taken along lines  20 — 20  of FIG.  15 . 
     FIG. 21 is a top plan view of the one-piece dental appliance. 
     FIG. 22 is a bottom plan view of the one-piece dental appliance. 
     FIG. 23 is a cross sectional view taken along lines  23 — 23  of FIG. 21 showing a shock absorbing chamber which alternately may be employed in the one-piece design. 
     FIG. 24 is a broken away figure of the one-piece dental appliance with two of the three cut away portions being partially removed. 
     FIG. 25 is a side elevational view of the jaws of the user with structure broken away to show the one-piece embodiment of the appliance being fitted to the mouth. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     To understand the structural features and benefits of one embodiment of the dental appliance  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 . 
     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 . 
     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)} to {fraction (1/32)} inch thick. The articular eminence  30  forms the beginning of the glenoid fossa  32  or the socket of the temporomandibular joint  32  and  50 . Rearwardly and posteriorly to the articular eminence  30  is located cartilage or meniscus  34 . Through the temporomandibular joint  32  and  50  pass the auriculo-temporalis nerve  36  and the 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  31  which terminates rearwardly into the soft palate. 
     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 temporomandibular joint  32  and  50 . The anatomical structure is the same for both sides of the head. 
     Repeated impacts, collisions, blows, stress or forces exerted on the movable lower jaw  42  result in excessive wearing forces upon the condyle  50  and the cartilage or meniscus  34 —typically resulting in deterioration or slippage of the cartilage  34 . Thereafter, the lower jaw  42  may be subject to irregular movement, loss of comfortable range of movement, and clicking of the joint  32  and  50 . 
     The auriculo-temporalis nerve  36  relates to both sensory and motor activity of the body. Any impingement or pinching of this nerve  36  can result in causing the brain to cause cessation of clenching activity, resulting in the loss of power. The supra-temporal artery  38  is important in that it provides blood circulation to 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 the brain. Thus, it is extremely important to assure that the condyle  50  does not put pressure upon the bony structure around the auriculo-temporalis nerve  36  or the supra-temporal artery  38 . 
     It is also important to note that glenoid fossa of the temporal bone  28  is not too thick. Medical science has known that a sharp shock, stress, or concussive force applied to the lower jaw  42  possibly could result in the condyle  50  protruding through the glenoid fossa of the temporal bone  28 , thereby causing death. This incident rarely, but sometimes, occurs with respect to boxing athletes. 
     Referring to FIGS. 2 through 13, the adjustable customized dental appliance embodiment  70  may generally be seen. 
     The appliance  70  has posterior occlusal pads  72  each including a base  74  for receiving the posterior teeth  22  of the lower jaw  42  as further explained below. The base  74  has an inner surface  80  facing the lower jaw posterior teeth  48 . Extending downwardly from base  74  is the labial wall  82  and lingual wall  84 . Connecting the respective labial walls  84  of both pads  72  is an adjustable band  86  which is shaped as to lie out of the way of the tongue  39 . Enclosed by the base  74 , labial wall  82 , and lingual wall  84  is a channel  87 . 
     Optionally, the posterior occlusal pads  72  may have raised portions  90  on the inner surface  80  of the base  74  (FIG.  5 ). The occlusal pads  72  and raised portions  90  should suitably be made of a thermoplastic rubber such as that marketed under the trademark Kraton® which is marketed by GLS Plastics of 740B Industrial Drive, Gary, Ill. 60013. This thermoplastic rubber is unique in that it is injection-moldable, FDA approved, and readily adheres with copolymers of ethylene and vinyl acetate. Furthermore, the thermoplastic rubber has a melting or softening point significantly higher than that of EVA which will facilitate fitting of the dental appliance  70  to the user or athlete&#39;s mouth  10 . Furthermore, the thermoplastic rubber, unlike copolymers of ethylene and vinyl acetate, exhibits high resilience, low compression, shape maintenance and shock absorption, attenuation and dissipation. Virtually all rubbers exhibit these physical characteristics which may be utilized for the posterior pads  72  and raised portions  90 . 
     The raised portions  90  are arranged suitably to be in the bicuspid or molar regions of the teeth  46  and  49 . The raised portions  90  may preferably take the form of cones but may also be spheres, columns, or knobs. 
     The posterior pads  72 , and optionally the raised portions  90 , cause the mandible or lower jaw  42  to slide forwardly and slightly downwardly while fitting the dental appliance  70 . Also, the condyles  50  are moved downwardly and away from the fossae or sockets  32  without the need for exotic devices and/or measurements, articulation, etc. Furthermore, optional raised portions  90  assure proper fitting of the appliance  70 , as will be further discussed below. 
     As is also to be appreciated that the occlusal pads  72  space apart the anterior teeth  18  and  46  while the adjustable band  86  is clear of the tongue  39  which will readily permit the wearer to easily breathe in power fashion as well as convey the ability to speak clearly. 
     The adjustable band  86  is preferably adjustable from side to side, as shown in FIG. 6, to adapt to the lateral spacing between the two sets of posterior teeth  48 . The adjustable band  86  is also preferably adjustable fore and aft, as shown in FIG. 4, to adjust to the location of the posterior teeth  48  within the mouth. In this way, the appliance  10  may be manufactured in a single size which should fit the majority of mouth sizes. 
     The adjustable band  86  is preferably made of a malleable metal which may be bent, as shown in FIG. 6, to adjust the lateral separation between the posterior pads  72  and to maintain the lateral separation after adjustment. Preferably, the malleable metal is titanium, which is light and non-corroding. Alternatively, the malleable metal could be a gold alloy or stainless steel. 
     As can best be seen in FIG. 4, the appliance  10  preferably includes a slot  92  in the labial wall  82  of the posterior pads  72  and an insert  94  on the posterior ends  96  of the adjustable band  86 . The insert  94  slidingly and frictionally engages the slot  92  to allow fore and aft adjustment of the posterior pads, as shown in FIG.  4 . Preferably, the insert  94  has a plurality of serrations  98  which frictionally engage the slot  92  allowing fore and aft adjustment and maintenance of the adjustment after adjustment is complete. 
     As can best be seen in FIGS. 7 and 8, the adjustable band  86  preferably engages the anterior surfaces of the anterior teeth  46  of the lower jaw  42 . In the preferred embodiment, the adjustable band  86  is substantially U-shaped and the arms  100  of the adjustable band  86  curve downward from the posterior pads  72  to engage the anterior surfaces of the anterior teeth  86 . This keeps the arms  100  out of the way of the tongue. 
     To fit the appliance  70  to the wearer, an impression of the lower teeth may first be taken, as shown in FIG. 2, on a sizing strip  102 , as has been described in U.S. Pat. No. 5,385,155, hereby incorporated by reference. This forms a dentition imprint  106 . Alternatively, the dentition imprint  106  may be taken on any suitable medium  108 , such as wax, cardboard, tin foil, styrofoam, or paper, as shown in FIG.  3 . 
     After the dental imprint  106  is taken, the appliance  70  is laid on top of the dental imprint  106  and the lateral separation between the posterior pads  72  is adjusted, as has been earlier described and as shown in FIG.  7 . 
     Next, the appliance  70  is inserted into the mouth and the fore and aft adjustment of the posterior pads  72  is made to conform to the position of the lower posterior teeth  48  in the mouth, as has been earlier described and shown in FIG.  4 . As the adjustment is made, the adjustable band  86  is placed over the anterior teeth  46 . Also, the end cap  114  of the posterior pads  72  is placed over the rearmost of the lower teeth  48 . The appliance  70  is then held securely in place by the band  86  over the anterior teeth and the end cap  114  over the posterior teeth. 
     It will be seen that at this point, the appliance  70  has been accurately sized to the mouth of the wearer, as shown in FIG.  8 . However, the posterior pads  72  will not yet be accurately fitted to the posterior teeth  48  because the channel  87  is of a single size and the posterior teeth  48  have occlusal surfaces  49  which vary from person to person. 
     To complete the fitting of the appliance  70 , the appliance  70  is removed from the mouth and a moldable material  110  is inserted in the channel  87 , as shown in FIG.  9 . Alternatively, the appliance  70  may be manufactured with moldable material already inserted in the channel  87 . The appliance  70  is reinserted into the mouth and the wearer bites down, causing the teeth of the upper and lower jaw to occlude about the appliance  70 . The lower teeth  48  will optionally contact the raised portions  90  preventing the lower teeth  48  from contacting the base  74  and from causing excess of the material  110  from being forced out of the channel  87 . As can be seen in FIG. 8A, the raised portions  90  also cooperate with the moldable material  110  to allow occlusal registration of the lower teeth  48  and the base  74 . That is, the raised portions  90  slide along the occlusal surfaces  49  until the raised portions  90  are in a valley  112  on the occlusal surfaces. As can be seen in FIG. 11, a small amount of the moldable material  110  is forced out of the channel  87  and lies along the buccal surfaces of the lower teeth  48 . FIG. 12 shows the result of this step. The moldable material  110  will have a dentition impression  116  of the lower teeth and will now be customized to the mouth. 
     Finally, the appliance  70  is removed from the mouth and the moldable material is hardened by an appropriate method producing a completely fitted appliance. 
     The moldable material may be a light-curing resin which is soft when in the dark but becomes hardened when exposed to light. Such a light-curing resin may preferably consist essentially of methyl methacrylate, chlorosulfonated polyethylene, fluoridated methacrylate, methacrylic acid, and photo initiators. A suitable light-curing resin is available under the name Spectra Tray from Ivoclar AG, Bendererstrasse 2, FL-9494 Schaan/Liechtenstein. 
     Alternatively, the moldable material may be a low-temperature, moldable, thermal plastic such as ethylene vinyl acetate (EVA). It has been found that EVA is a commercially available compound and approved for oral use by the Food and Drug Administration. Another possible moldable material may be the Hydroplastic™ material from TAK Systems, P. O. Box 939, East Wareham, Mass. 02538. 
     To fit the appliance  70 , the appliance  70  may momentarily be submersed suitably in boiling water. Thereafter, the appliance  70  is immediately placed onto the posterior teeth  48 . The wearer then applies suction between the lower jaw  42  and the appliance  70  while packing the appliance  70  with the hands along the cheeks adjacent the posterior teeth  48 . 
     By this action, the user of the appliance  70  will have correct jaw posture for athletic participation once fitting has been completed. The posterior teeth  48  of the lower jaw  42  will properly index upon the inner surfaces  80  of the occlusal pads  72 . Should the raised portions  90  optionally be embedded within the pads  72 , they will absorb, attenuate and dissipate shock and stress forces such as created by clenching. Furthermore, the user will experience increased endurance, performance, and muscular freedom due to the power positioning and posture of the TMJ joints  32  and  50 . 
     Referring to FIGS. 14 through 25, the one-piece customizable dental appliance  170  may generally be seen. 
     The appliance  170  has posterior occlusal pads  172  each including a base  174  having a forward or anterior score line  175  forming a removable forward portion  176 . Base  174  also has two rearward or posterior score or serration lines  177  forming first and second respectively removable rearward portions  178  and  179 . The base  174  has an inner surface  180  and an outwardly downwardly extending or depending labial wall  182 . Pads  172  are connected by forwardly and downwardly extending band  186 . Inner surface  180  and labial wall  182  form a channel  187  for receiving the posterior teeth  48 . 
     The one-piece customizable dental appliance  170  may be made of a variety of thermoplastic or elastomeric moldable compounds. For instance, ethylene vinyl acetate (EVA) is a good thermoplastic FDA approved. Neoprene may also work well. Elastomeric rubbers (such as Kraton®) produced by GLS Plastic of 740B Industrial Drive, Gary, Ill. 60013, also is an FDA approved elastomer with significant durability which works well with the appliance  170  as previously described. 
     As FIG. 23 reveals, base  174  may have shock or cushioning chambers  200  which suitably may be filled with cushioning media  202  which may include air, gel, neoprene or Kraton materials. A raised portion  190 , similar to  90 , may also be included. 
     In fitting the one-piece customizable dental appliance  170 , the wearer may use the sizing strip  102  or dentition imprint  108  as previously described. Next, the appliance  170  may be placed over the teeth imprint  106  to determine if any of the removable portions  176 ,  178  or  179  should be removed. Alternatively, the user may simply place the appliance  170  in his or her mouth and feel the appliance  170  for a proper fit with fingers and tongue. Thereafter, a knife  204  (FIG. 24) may be utilized to follow score or serration lines  175  or  176  to remove unnecessary portions  176 ,  178  or  179  to assure a proper fit as shown in FIG.  25 . 
     The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof; and it is, therefore, desired that the present embodiment 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.