Abstract:
A mouthpiece that adjusts manually to accommodate a broad range of different size sets of upper and lower teeth in the mouth and yet seals the treatment area from oxygen exposure. The mouthpiece includes light emitting diodes and heat generating resistors all arranged in an array. A series of parallel texture bands are provides to guide and direct the light from the LEDs to diffuse generally evenly onto teeth to be treated. The seal arises from an inner surface of the mouthpiece titling inwardly so that a seal bead seals in the vicinity of the gum above the teeth to be treated.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    This application is a Continuation-in-Part of application Ser. No. 12/246,012, filed on Oct. 6, 2008. The present invention relates to a mouthpiece containing lamps and heat resistors to expose electromagnetic radiation to effect oral treatment and, specifically, to aid the activation of an adhesive whitening gel to whiten teeth. The present invention may also be used to kill harmful bacteria in the mouth through the electromagnetic radiation exposure and the activation of various formulations. The mouthpiece adjusts manually to accommodate a broad range of user sizes, yet seals the treatment area from oxygen escape. 
         [0003]    2. Description of Related Art 
         [0004]    Conventional teeth whitening in the dental office takes up to two hours, may be painful and is often costly with noticeable regression beginning in about seven days after the treatment. Improved whitening results are experienced in a professional setting using white light in the 300-990 nm range, but this procedure may be costly and time consuming. Over-the-counter products suffer from other deficiencies, such as difficulty of use, irritation to the soft tissue and the root surfaces and the results usually take up to 14 days. Often, there is only minimal improvement. The consumer needs a customizable whitening alternative that yields results similar to professional whitening, but at the convenience of the home. 
         [0005]    Dentist-supervised tooth whitening involves the controlled use of carbamide or hydrogen peroxide, tailored to a particular patient. Dentists may administer in-office treatments or at-home treatments. Before the tooth whitening treatment, most dentists clean the teeth, fill cavities, and ensure the patient&#39;s gums are healthy. 
         [0006]    Most in-office tooth whitening systems use 15 to 35 percent hydrogen peroxide gels, coupled with a high intensity light to expedite the bleaching chemical reaction. 
         [0007]    The in-office whitening procedure involves the dentist gently cleaning the teeth with pumice and then applying a protective barrier on the gums. The dentist then applies hydrogen peroxide paste on the teeth for 15-20 minutes, rinses the hydrogen peroxide off, and usually reapplies hydrogen peroxide 3-4 times. The procedure can achieve about four to six shades of whitening after one 60-80 minute treatment and the patient often times experiences electric-type pain called zingers due to the long exposure to the light and heat. 
         [0008]    The other professionally administered whitening technique is the at-home tray and gel system. This will often use 10 to 20 percent carbamide peroxide gels that also contain glycerin, carbomer, sodium hydroxide, water, and flavoring agents. Some gels that contain more than 10 percent carbamide peroxide will also include sodium fluoride to reduce sensitivity and strengthen teeth. 
         [0009]    To begin the at-home procedure, the dentist takes impressions (molds) of the mouth, and then has soft, custom mouth trays made. In administering treatment, the user places a thin ribbon of the gel into the tray and wears it for two hours during the day, or while sleeping. Most whitening occurs in one to two weeks. In difficult cases, trays may need to be worn for up to six weeks. Since the peroxide gel is placed into the custom mouth tray and then seated into the mouth, the gel moves onto the roots of the teeth and the soft tissues of the mouth, causing sensitivity in the majority of users. 
         [0010]    A combination of in-office and at-home systems can achieve up to 5-7 shades of whitening. Such a procedure is considered safe and effective when monitored by a dentist. 
         [0011]    Dentist supervised systems have advantages and disadvantages when compared to over-the-counter tooth whitening products. The main advantage of the dentist supervised system is that the dentist can determine if tooth whitening should be performed and if it will be effective for the patient. Patients with decayed teeth, infected gums, white spots on their teeth, and multiple tooth colored fillings or crowns (caps) on the front teeth may not be good candidates for tooth whitening. 
         [0012]    The dentist can also help decide what type of tooth whitening is required (in-office, at-home or both) and the concentration of the whitening gels. The dentist can monitor and treat patients who experience sensitivity to the whitening agents and modify the procedure for those who are having difficulty getting optimal results. Finally, the dentist can help the patient explore porcelain or resin veneers, tooth colored fillings, gum lifts and tooth shaping used with or without tooth whitening. With the help of the dentist, the patient&#39;s cosmetic dental goals may be more easily attained. 
         [0013]    The disadvantages of dentist supervised whitening systems include higher cost and longer time required to get started and a high level of sensitivity for both the in-office professional whitening and the at-home tray and gel technique. The in-office and at-home tooth whitening systems can cost between $300-$1,000 (sometimes more). In most cases, at-home systems cost less than the in-office systems. With the dentist supervised systems, there may be a wait to get started. You have to schedule an appointment, wait to be seen and evaluated, and then be treated. 
         [0014]    Whitening results are best achieved when there is high frequency of use of the whitening agent, in a safe manner without high concentrations of whitening agents that can burn the gum tissue. By increasing the frequency of the whitening by giving the consumer the ability to whiten at home, the regression of the whitening is greatly reduced or even eliminated. That is, high frequency of use and low intensity peroxide gels are more desirable than low frequency of use and high intensity peroxide gels. 
         [0015]    It is desired to provide a whitening device (mouthpiece) that is coupled with a delivery system of the whitening gel and an adhesive that keeps a photosensitive agent, such as carbamide or hydrogen peroxide, targeted to the area to be whitened, i.e. to the tooth surface. Such a whitening device preferably causes no harmful breakdown by-products, and is hygienically delivered in a single dose. 
         [0016]    Further, it is desired to have an adjustable whitening device (mouthpiece) to accommodate a broad range of different size sets of upper or lower teeth of users. It is further desired that the whitening device seal off the area in the mouth to be treated to reduce the amount of oxygen escape, thus having more oxygen molecules bombard the surface of the tooth for whitening. 
         [0017]    In addition, harmful bacteria responsible for causing gum disease in the mouth, specifically, the gram negative anaerobic bacteria, are killed by exposure to electromagnetic radiation in the form of ultraviolet light and heat over 50 degrees C. It would therefore be desirable for a consumer to expose such bacteria to ultraviolet light and heat as well. 
       SUMMARY OF THE INVENTION 
       [0018]    One aspect of the invention resides in an intra-oral whitening device or mouthpiece suited to create a whitening and heat effect to increase a reaction rate of a photosensitive agent, such as carbamide or hydrogen peroxide gel. The person whose teeth are to be whitened can wear the device and whiten his/her teeth without the need of a professional office in a safe, effective, convenient and economical fashion. 
         [0019]    The intra oral whitening device (or mouthpiece) of the present invention allows whitening teeth in the convenience of one&#39;s home with LED-based white light technology and heat resistors and to customize the whitening procedure safely and effectively without the need for a dentist. The mouthpiece adjusts its orientation manually to accommodate a broad range of different size sets of upper or lower teeth of users and to seal a treatment area in the mouth against exposure to oxygen. The design of the mouthpiece allows for a universal size to fit all people due to the flexible circuit that houses the LEDs and the heat resistors. Additionally, the warming heat from the heat resistors helps the TPR rubber, or silicone mouthpiece to conform to the user&#39;s mouth anatomy, thus creating a sealed environment that prevents oxygen escape for whitening and creates more efficient whitening. This creates less wear time and thus less sensitivity during the whitening process. Additionally, the heat generated from the resistors is specifically to ramp up to 52 degrees C. as the 4 eight minute applications are done by the user. This prevents the high heat and high exposure seen in professional whitening lights, and thus much lower sensitivity. Instead of 4 twenty minute applications of the professional whitening as a “one time shot,” in this invention, there are 4 eight minute applications that are done over a number of days in a row. 
         [0020]    Another aspect of the invention is to expose harmful bacteria in the mouth to electromagnetic radiation, such as ultraviolet light and heat. By doing so, the spread of gum disease caused by the harmful bacteria, such as gram negative anaerobic bacteria, is halted because the ultraviolet light and the warming heat above 50 degrees C. kills the harmful bacteria. Additionally, the bacteria that causes bad breath also lives without oxygen in the nooks and crannies of the tongue and between the teeth. Once exposed to oxygen, these gram negative anaerobic bacteria are killed by the oxygen and the sealed environment of the mouthpiece. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0021]    For a better understanding of the present invention, reference is made to the following description and accompanying drawings, while the scope of the invention is set forth in the appended claims: 
           [0022]      FIG. 1  is an isometric view of a dental mouthpiece in accordance with the invention. 
           [0023]      FIG. 2  is a partially broken isometric view of the dental mouthpiece of  FIG. 1 . 
           [0024]      FIGS. 3A-3C  are top views of the dental mouthpiece of  FIG. 1  that illustrate how the dental mouthpiece is adjusted to open from the position reflected by  FIG. 3A  to that of  FIG. 3B  and to close from the position reflected by  FIG. 3A  to that of  FIG. 3C . 
           [0025]      FIG. 4  is a cross-section through a centerline of the dental mouthpiece of  FIG. 1 . 
           [0026]      FIG. 5  is cross-section of the dental mouthpiece of  FIG. 1  with respect to a user&#39;s tooth. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0027]    During a teeth-whitening treatment in a dental office, a whitening gel is applied to the teeth and a protective barrier is placed on the gums, the mucosa and lips to prevent burning of the tissues by the high concentration of hydrogen peroxide in the whitening gel. A leading edge of the whitening gel is placed on a tooth surface. An LED-based white light is placed a few inches from a tooth surface to help activate free radical oxygen, most of which becomes lost into the air. In this invention, the mouthpiece seals or encloses a photosensitive agent, such as carbamide or hydrogen peroxide gel, to prevent the loss of the active electrons of the photosensitive agent (carbamide or hydrogen peroxide) into the air. 
         [0028]    The mouthpiece holds LED-based white light sources and alternating heat resistors. A power source, which may be remote from the mouthpiece, is in electrical connection with the LED-based white light sources and heat resistors via a wire. The power source energizes the LED-based white light sources and heat resistors which generate light rays and a warming heat. The light rays strike the tooth surface on the front and the edge and the back of the edge, i.e., in all directions, while the mouthpiece is in its intended position relative to the tooth surface. 
         [0029]    Further, a “closed system” created by the mouthpiece or guard that seals or encloses (against exposure to the atmosphere) is efficient for keeping the active free radical oxygen in close proximity to the teeth to enable their movement onto the tooth surface to breakdown the color pigments inside the tooth. A much lower concentration of the carbamide or hydrogen peroxide gel may be used in comparison to what would be needed to achieve like results in an “open system” that did not seal or enclose the photosensitive agent (carbamide or hydrogen peroxide) from exposure to atmosphere. 
         [0030]    Indeed, the whitening device (mouthpiece) or the present invention may be used for seven to ten consecutive days with little to no sensitivity to the teeth and gums. This seven to ten consecutive day use constitutes a higher frequency of use than is available in conventional professional whitening techniques and helps avoid a regression phenomenon that has been observed in the professional whitening technique. 
         [0031]    The mouthpiece  10  adjusts to a broad range of user dental arch sizes (curvature attributed to lower or upper sets of teeth). It also distributes light and heat in a controlled and focused fashion and provides a means of sealing an area being treated from exposure to oxygen. The heat generated from the alternating heat resistors molds the thermoplastic material of the mouthpiece, i.e., TPR rubber or medical grade silicone, to the user&#39;s anatomy and creates the closed system around the formulations, preventing oxygen escape, and thus lower wear time, and thus lower sensitivity for the user. 
         [0032]    Referring to  FIGS. 1 and 2 , the mouthpiece  10  includes upper and lower edges  11 ,  13  ( FIG. 2 ) and a bite surface  12  formed of segments. The bite surface  12  is perpendicular to the main body  14 . The bite surface is also central with respect to the main body  14 , with substantially equal portions of the main body  14  above and below the bite surface  12  as seen in  FIGS. 2 and 4 . 
         [0033]    Referring to  FIG. 2 , the mouthpiece  10  is formed of a clear, elastomeric, molded outer shape  14  that encases a flexible circuit board  22 . There is a deformable frame  28  that holds the circuit board  22  during fabrication and may be bent by the user to adjust the orientation of the mouthpiece  10  to set the arch for comfort in the user&#39;s mouth. The bite surface  12  is preferably segmented as shown in  FIG. 1  to help facilitate the adjustability of the mouthpiece  10  to mouths of differing dimensions. Additionally, adjustability of the mouthpiece  10  to the shape of the arch of the user is facilitated when the heat generating resistors  26  are activated. This is because the heat so generated softens the mouthpiece  10  and increases its malleability, thereby allowing it to be bent and flexed to conform to the particular configuration of the user&#39;s arch. 
         [0034]    A series of super bright light emitting diodes (LEDs)  24  and heat generating resistors  26  are arrayed on an inner, lingual side of the flexible circuit board  22 . The power cord  20  is centrally attached to the outer surface. Looking at  FIG. 2 , there are 3 rows of elements, with the top and bottom rows preferably entirely including heat generating resistors  26  and with the middle row preferably entirely consisting of LEDs  24 . As shown in  FIGS. 4 and 5 , the LEDs  24  are preferably coplanar with the bite surface  12 . 
         [0035]    A parallel series of textured bands  16 , whose surface texture resembles elongated convex surfaces configured to channel LED light, are formed on the lingual side of the outer shape  14  for the purposes of LED light diffusion over the surface of the tooth being treated. 
         [0036]    Referring to  FIG. 3A , areas between the segmented bite surfaces  14  allow the device to open as in  FIG. 3B  or close as in  FIG. 3C . 
         [0037]    Referring to  FIG. 4 , an inner surface  30  of the mouthpiece  10  tilts inward at an angle of 5 to 15 degrees as noted by B to seal the seal bead  18  and borders the edge of the mouthpiece  10 . 
         [0038]    Referring to  FIG. 5 , the inward tilt of the inner surface  30  allows the seal bead  18  to contact the gum above the tooth. This contact provides a barrier seal to both retain the whitening gel and to prevent oxygen from entering the treatment area of the tooth (that is to be treated with the whitening gel). 
         [0039]    The light  32  emitted by the LEDs  24  is guided and directed to more evenly illuminate the surface of the teeth by the textured bands  16 . The texture of the textured bands  16  provides surfaces that are closer to perpendicular to the light path and less reflective than the generally polished surface of the mouthpiece. The light  32  emitted by the LEDs  24  is directed into both the spaces above and below the bite surface  12  as shown in  FIG. 5 . 
         [0040]    While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various changes and modifications may be made without departing from the spirit and scope of the present invention.