Patent Description:
The invention presents an internal, oral device to deliver a range of specified light wavelengths on the inside the mouth to promote tissue healing and bone growth.

Currently, devices use light waves to promote oral healing, but such devices are extra-oral, i.e., they are affixed externally to the cheek or other areas of the face. The lightwaves from such devices must penetrate the cheek wall and/or other skin, bone and tooth structures of the head and oral region. As a result, the efficacy of the light waves from such devices is diminished as is their therapeutic properties. Delivering light waves from inside the mouth directly to the oral tissues as the invention proposes, is a superior delivery system vis-a-via existing extra-oral devices. Positioning the light sources closer to the target tissues improves the efficacy of this treatment protocol.

Appliances on the market today attempt to deliver light to internal mouth tissues (see <CIT> assigned to Biolux Research LTD; see also <CIT>). Such devices, however, are extra-oral devices that deliver inferior light-rays to diseased oral tissues and bone structures including the hard palate and sub lingual tissues. It is preferable to have a completely intra-oral appliance that maintains the proper light intensity and frequency that is not lost or diffused through extra-oral and hard tissues. Existing appliances do not have the appropriate power versatility and light wavelengths to be effective within the oral cavity.

The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will be best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings and photographs, wherein:.

The detailed description set forth below is intended as a description of the presently embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the functions and sequences of steps for constructing and operating the invention. It is to be understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments and that they are also intended to be encompassed within the scope of the invention.

Several embodiments of Applicant's invention will now be described with reference to the drawings. Unless otherwise noted, like elements will be identified by identical numbers throughout all figures. The invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein.

<FIG> depicts an embodiment of the presently described intra-oral appliance. Oral appliance <NUM> in one embodiment is manufactured from clear non-latex rubber formed into an arch-bite block that encircles the gums and adjacent areas of the mouth. The material is highly translucent. The light-ray treatments are delivered to the gums, interior cheeks, and related structures thought the material. Oral applicance <NUM> comprises a disposable barrier sleeve of clear plastic to allow proper infection control and reusability of the device. The attached drawings delineate the form and dimensions of the appliance. The lights embedded within the appliance are specialized LED lights <NUM> that emit specific broad range red, near-infrared and blue spectrum light. LEDs <NUM> will be aligned on the buccal rim <NUM> and lingual rim <NUM> of the device. As shown in <FIG>, outer flange <NUM> and inner flange <NUM> are constructed to keep oral tissues extended to improve light exposure. A controller (discussed in reference to <FIG>) can control the amplitude and frequency of the light-rays in addition to oscillations between red, near-infrared and blue wavelength exposure. Oral appliance <NUM> exposes virtually all internal tissues of the mouth including the buccal, palatal, lingual and sub-lingual tissues to the light waves generated by the light source at virtually the same time.

Antenna <NUM> equipped with a universal serial bus (USB) connector <NUM> that allows for control of application of specific light rays and exposure to intra-mouth tissue via LEDs <NUM> in appliance <NUM>. This permits wired or wireless control of appliance <NUM>.

Oral appliance <NUM> in one embodiment has the shape of a mouth guard having a bite plane <NUM> for receipt of the upper and lower teeth of a patient for situating appliance <NUM> in the mouth in a secure and predictable manner. In one embodiment appliance <NUM> has an outer circumference of approximately <NUM> millimeters, but sizes can vary with a circumference in the <NUM> to <NUM> millimeter range for users of different sizes. In an embodiment bite plane <NUM> has a width a of approximately <NUM> millimeters, although size here can vary.

Oral appliance <NUM> in an embodiment comprises a clear silicone material that has embedded into it the LED lights <NUM> or a microprocessor chip that provides optimal light delivery. This embedded configuration completely seals the power harness <NUM> (<FIG>) for maximum moisture control. In addition to delivery of red and near-infrared light waves, according to an embodiment of the present invention blue light waves are also delivered. blue light waver have been shown to have a strong anti-microbial effect producing a controlled antiseptic environment to the oral cavity that promotes healing. Also, unlike existing appliances, the presently described oral appliance delivers highly adjustable light wave intensities and a wider range of wavelengths all of which are necessary to optimize tissue healing and bone growth. A host of oral conditions are chronic and inflammatory in nature and are usually associated with autoimmune deficiencies (e.g., lichen planus). Such conditions have no cure so current treatments are only palliative. Recent research has shown that exposure to specific light in the infrared/red range has a healing and stabilizing effect on these tissues. Such treatments make patients with these conditions more comfortable and offer long-term relief.

In addition to the autoimmune diseases addressed by the present invention, the device treats Periodontal Disease - the most common disease in mankind. This condition has no cure, but the inter-oral device's enhanced light therapy has shown promising results in the management and treatment of Periodontal Disease. Clinicians testing the device believe this success is due in large part to the enhanced exposure of diseased tissue to the infrared/red light spectrum afforded by the device.

Researchers have concluded that the septic and uncontrolled health of the oral cavity has an important impact on the overall health of patients. For example, diabetic patients have difficulty controlling their blood chemistry's when they present chronic septic oral conditions. Cardiac patients have significant blood enzyme level alterations when uncontrolled oral septic conditions and periodontal disease are present. These septic conditions are not simply of dental origin but are an entire oral cavity/periodontium complex. Routine dental office hygiene visits cannot adequately treat these conditions, which require additional daily maintenance through the light therapy produced by the device.

Additional uses for this light photo therapy are the treatment of :.

<FIG> depicts a front view of oral appliance <NUM>. As shown an upper portion of appliance <NUM> from USB port <NUM> to the upper edge of outer flange <NUM> in one embodiment is approximately <NUM> millimeters (see b), although sizes can vary. The lower portion of appliance <NUM> from USB port <NUM> to the farthest point of outer flange <NUM> is approximately <NUM> millimeters (see c) in one embodiment, although this distance can vary. Note that front profile of oral appliance <NUM> is oblong in a figure-<NUM> like shape. <FIG> depicts a side view of oral appliance <NUM>. Note that from the side oral appliance <NUM> is substantially of an oblong and oval shape.

<FIG> depicts a cross sectional view of oral appliance <NUM> with reference to points S-S in <FIG>. The front portion of oral appliance <NUM> comprises power harness <NUM> that is embedded in silicone of outer flange <NUM>. In one embodiment, the width of bite plane (see d) is approximately two millimeters but the width can be between <NUM> and <NUM> millimeters. Outer flange as shown in one embodiment has a thickness of approximately <NUM> millimeters (see e), although the thickness can vary between <NUM> millimeters and <NUM> millimeter.

<FIG> depicts components of an intra-oral appliance system according to an embodiment of the present invention. As shown in <FIG>, the intra-oral appliance system in one embodiment is comprised of PBT controller <NUM>, converter box and interface cable <NUM>, universal input A/C adapter <NUM> and mouthpiece <NUM>. In one embodiment, mouthpiece <NUM> shares the features of oral appliance <NUM>. In another embodiment, mouthpiece <NUM> comprises the features as described below. Mouthpiece <NUM> includes red and blue LEDs for near infrared reflectance (NIR) spectroscopy to analyze characteristics of the tooth and gums. These components enable operator control through controller <NUM> of the frequency and amplitude of light emitted from the LEDs housed in mouthpiece <NUM> when mouthpiece <NUM> is intra-oral.

<FIG> depicts a cross sectional view of mouthpiece <NUM> of an intra-oral appliance system according to an embodiment of the present invention. As shown in <FIG>, mouthpiece <NUM> comprises an outer side <NUM> and inner side <NUM>. Inner side <NUM> of a mouthpiece <NUM> surrounds tooth <NUM> and gums <NUM>. Outer side <NUM> and inner side <NUM> of mouthpiece <NUM> are correspond to outer flange <NUM> and inner flange <NUM> of <FIG> but more detail is provided in this <FIG>. The inner side <NUM> of mouthpiece <NUM> comprises a pair of gum LEDs <NUM> and <NUM> and molar LED <NUM> within pre-molded silicone in the form of inner silicone cover <NUM>. Gum LED <NUM> and molar LED <NUM> are associated with first flexible printed circuit board (PCB) <NUM>. Gum LED <NUM> is associated with second flexible PCB <NUM>. First flexible PCB <NUM> and second flexible PCB <NUM> are associated with carrier <NUM>. This arrangement permits collection of near-infrared (NIR) data by mouthpiece <NUM> and delivery of data to PBT controller <NUM> for further analysis. The exterior of the mouthpiece <NUM> is covered or housed by a transparent outer silicone case <NUM>. First PCB <NUM> and second PCB <NUM> of mouthpiece <NUM> are coated with silicone pre-mold <NUM>. Outer silicone case <NUM> and inner silicone cover <NUM> can be pre-molded silicone or made of injection molded silicone.

In one embodiment of the mouthpiece of the present invention, an outer (gum and molar) mouthpiece component can include <NUM> red LEDs and <NUM> NIR LEDs and an inner (gum) mouthpiece component can include <NUM> blue LEDs and <NUM> NIR LEDs. "Outer" in this regard refers to the outside face of the gums and molars while "inner" refers to the side of the gums and molars facing the inside of the mouth. Red/NIR LED wavelength is in the <NUM>-<NUM> range. Blue/NIR LED wavelength is in the <NUM>-<NUM> range.

<FIG> depicts an aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. <FIG> depicts the various flexible PCBs that comprise the components of mouthpiece <NUM> when in use and associated with the inner jaw and outer jaw. As shown, each component of mouthpiece <NUM> comprises portions of PCBs containing a plurality of red and blue LEDs placed on flexible PCB portions using surface-mount technology (SMT). The inside and outer components of the mouthpiece in flat form are shown in <FIG> with first PCB <NUM> portion associated with the outer jaw comprising a PCB tongue <NUM>. First PCB <NUM> has associated gum LED <NUM> and molar LED <NUM>. Second PCB <NUM> associated with the inside jaw also includes a corresponding PCB tongue <NUM>. Second PCB <NUM> portion has associated gum LED <NUM>. When first PCB <NUM> and second PCB <NUM> are joined as shown in <FIG>, tongues <NUM> and <NUM> will be joined. As discussed with the respect to <FIG>, second PCB <NUM> has mounted on it one gum LED <NUM> and first PCB <NUM> portion of the mouthpiece for the outer jaw has upon it mounted a second gum LED <NUM> and a molar LED <NUM>, as shown in the respective cross-sectional views in <FIG>.

<FIG> depicts an aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In this step, pre-molded SMT flexible PCB has disposed thereon a transparent silicone layer. As shown in <FIG>, second PCB <NUM> associated with the inside jaw has disposed thereon the one gum LED <NUM> with transparent silicone pre-mold <NUM> covering that LED <NUM>. Similarly, first PCB <NUM> associated with the outer jaw has disposed thereon gum LED <NUM> and molar LED <NUM> with transparent silicone pre-mold <NUM> covering LEDs <NUM> and <NUM>. These arrangements having the transparent silicone pre-molds <NUM> and <NUM> are the respective PCB bottom pre-molds, PCB bottom pre-mold <NUM> for first PCB <NUM> and PCB bottom pre-mold <NUM> for second PCB <NUM>. Associated with each bottom pre-mold is a PCB top pre-mold, with PCB top pre-mold <NUM> for first PCB <NUM> and PCB top pre-mold <NUM> for second PCB <NUM>, each disposed above the respective bottom pre-mold for each.

<FIG> depicts another aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In <FIG>, the resulting mouthpiece <NUM> components first PCB <NUM> and second PCB <NUM> are shown before and after the pre-mold application steps described with respect to <FIG> are completed. As shown first PCB tongue <NUM> and second PCB tongue <NUM> remain uncoated while the remaining portions of first PCB <NUM> and second PCB <NUM> of mouthpiece <NUM> are coated with the silicone pre-mold <NUM>.

<FIG> depicts another aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In <FIG>, the fabrication process of the outer silicone case for mouthpiece <NUM> is shown. The fabrication process includes a top mold chase <NUM> and a bottom mold chase <NUM> used in an injection mold operation. Between each chase is an injection cavity <NUM> in which silicone is injected. The resulting outer silicone case <NUM> is shown, having opening <NUM> though which tongues <NUM> and <NUM> will be inserted later during construction of completed mouthpiece <NUM>.

<FIG> depicts an aspect of a method for mouthpiece <NUM> assembly of an intra-oral appliance system according to an embodiment of the present invention. In <FIG>, construction of a pre-mold silicone carrier is described. Again, top and bottom chases <NUM> and <NUM> are used to create injection cavity <NUM> for injection of silicone to create the resulting carrier <NUM>. Like the outer silicone case <NUM>, carrier <NUM> includes opening <NUM> that corresponds to opening <NUM> in the outer silicone case for receiving tongues <NUM> and <NUM>.

<FIG> depicts an aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In this step of the process, assembly of the various layers of mouthpiece <NUM> is shown. Dual PCB module <NUM> (the structure of which is described in <FIG>) is inserted into carrier <NUM> resulting in PCB-carrier module <NUM>. PCB carrier module <NUM> in turn is inserted into outer silicone case <NUM> to form resulting pre-encapsulated module <NUM>. Note that tongues <NUM> and <NUM> are inserted into corresponding opening <NUM> in carrier <NUM> and opening <NUM> in outer silicone case <NUM>. This process will be described in more detail below in connection with the various steps of <FIG>.

<FIG> depicts a bending process for mouthpiece <NUM> assembly of an intra-oral appliance system according to an embodiment of the present invention. As shown in <FIG>, flat first PCB <NUM> that corresponds to the front of the jaw includes gum LEDs <NUM> and molar LEDs <NUM>, as described. Flat first PCB <NUM> is bent into a horseshoe configuration. Then, wings <NUM> and <NUM> of first PCB <NUM> are bent inward at approximately a right angle in relation to the gum LED PCB flex portion <NUM>. Next, tongue <NUM> (comprised of tongues <NUM> and <NUM>) is bent outward. Cross-section views in <FIG> showing the wing inward bends (before and after) and tongue outward bend (before and after) are provided.

<FIG> depicts a bending process for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In this step, flat second PCB 722corresponding to the inside jaw portion of mouthpiece <NUM> is bent, first into a horseshoe. Long tongue <NUM> is bent inward. The cross-sectional view of the resulting second PCB <NUM> section of mouthpiece <NUM> before and after the inward bend of long tongue <NUM> is shown.

<FIG> depicts a module assembly process of an intra-oral appliance system according to an embodiment of the present invention. In this step, dual-PCB module assembly is completed by combining bent first PCB <NUM> and second PCB <NUM> modules as described in previous steps. Each of bent first PCB <NUM> and second PCB <NUM> are aligned with one another as shown with a dual layer tongue <NUM> resulting from tongue <NUM> from bent first PCB <NUM> (<FIG>) and long tongue <NUM> from bent second PCB <NUM> (<FIG>). The resulting dual-PCB module incudes outer gum LEDs <NUM> and molar LEDs <NUM> associated with outer jaw first PCB <NUM>, and inside gum LEDs <NUM> associated with inside jaw second PCB <NUM>.

<FIG> depicts a PCB electrical interconnection process of an intra-oral appliance system according to an embodiment of the present invention. In this step, electrical interconnection of the PCB is enabled. As shown, dual layer tongue <NUM> is inserted into socket PCB and soldered. Then a single or two piece (as shown) USB enclosure <NUM> is applied over dual layer tongue <NUM> and socket <NUM>. A dual PCB module assembly having a micro USB connector <NUM> associated with dual layer tongue <NUM> results.

<FIG> depicts an aspect of a method for mouthpiece assembly of an intra-oral appliance system according to an embodiment of the present invention. In this step, the assembled dual PCB module assembly is encapsulated in silicone. As shown in <FIG>, exposed LEDs, PCB and silicone carrier within outer silicone case are disposed within a top mold chase and bottom mold chase. The top and bottom mold chases leave an injection cavity on the interior side of dual PCB module, enabling silicone encapsulation of the exposed PCBs <NUM> and <NUM>, exposed LEDs <NUM>, <NUM> and <NUM> and silicone carrier <NUM>. After injection, the LEDs <NUM>, <NUM> and <NUM>, first PCB <NUM> and second PCB <NUM> and silicone carrier <NUM> are fully encapsulated with injected silicone <NUM>.

<FIG> provides perspective and cross-section views of the mouthpiece assembly resulting from the various steps herein described, both before and after silicone encapsulation. Assembled dual PCB <NUM> after undergoing the described silicone injection process results in encapsulated mouthpiece <NUM>, with LEDs <NUM>, <NUM> and <NUM> and first PCB <NUM> and second PCB <NUM> coated with silicone. Mouthpiece <NUM> is now ready for use and its electrical components are not susceptible to damage from fluids from the user's mouth or otherwise.

In some of the embodiments shown, the various LEDs are disposed on the exterior of the mouthpiece on both the buccal and lingual sides of the mouthpiece. In other embodiments, the various LEDs are disposed on the interior of the mouthpiece both on the buccal and lingual sides and on the interior bite plane. In other embodiments, however, LEDs are disposed both on the interior and exterior sides of the mouthpiece on the buccal, lingual and/or bite plane.

Furthermore, the mouthpiece <NUM> disclosed and described in one embodiment is a single u-shaped piece that can be placed on either the top or bottom teeth and gums of the user. In another embodiment, a double-sided mouthpiece is described in which upper and lower buccal and lingual rims and flanges have disposed thereon LEDs on either the interior, exterior or both sides of the mouthpiece. In other words, the double-sided mouthpiece includes a combined upper mouthpiece and lower mouthpiece with LEDs disposed on the interior, exterior or both that allows the user at one time to receive light treatments to both the upper gums and molars and the lower gums and molars. The construction of the double-sided mouthpiece can be performed in two stages as described herein for the single sided mouthpiece, one for the upper and one for the lower half. In the alternative, the PCBs can serve as the backbone for a single body construction of the double-sided mouthpiece.

While the disclosed embodiments have been described with reference to one or more particular implementations, these implementations are not intended to limit or restrict the scope or applicability of the invention. Those having ordinary skill in the art will recognize that many modifications and alterations to the disclosed embodiments are available. Therefore, each of the foregoing embodiments and obvious variants thereof is contemplated as falling within the scope of the disclosed inventions.

Claim 1:
An intra-oral appliance for use inside of a mouth, comprising:
a first printed circuit board comprising at least one light emitting diode positioned in a substantially opaque substrate for administering light waves on a first gum area and at least one light emitting diode for administering light waves on a tooth;
a second printed circuit board comprising at least one light emitting diode positioned in a substantially opaque substrate for administering light waves on a second gum area;
a first tongue extending from the center of the first printed circuit board and a second tongue extending from the center of the second printed circuit board;
a substantially u-shaped printed circuit board carrier module having a slot in the center for receipt of the first tongue and the second tongue and the first printed circuit board and the second printed circuit board;
a communication port connected to the first tongue and the second tongue for connection to a controller to provide control signals to the first printed circuit board and the second printed circuit board; and
an outer transparent case encapsulating the substantially u-shaped printed circuit board carrier module containing the first printed circuit board and second printed circuit board,
wherein the first printed circuit board and the second printed circuit board form a substantial u-shaped substrate, and
wherein the substantially u-shaped printed circuit board carrier module comprises a buccal rim, a lingual rim and a bite plane.