WO2008124918A1

WO2008124918A1 - Lightsource for soft oral tissue

Info

Publication number: WO2008124918A1
Application number: PCT/CA2008/000663
Authority: WO
Inventors: John Kennedy
Original assignee: Pharos Life Corporation
Priority date: 2007-04-11
Filing date: 2008-04-11
Publication date: 2008-10-23

Abstract

The invention is directed to a device and method for providing electromagnetic radiation to at least some of the soft oral tissues of a user such as the gums and tongue. The device includes a substrate for disposing in the mouth of a user proximal to at least some of the soft oral tissues and an electromagnetic radiation source disposed on the substrate for delivering radiation of a desired wavelength to the proximal soft oral tissues. The method includes the steps of placing the device in the mouth of a user proximal to at least some of the soft oral tissues and providing power to the electromagnetic radiation source to produce electromagnetic radiation at a desired wavelength for a selected length of time to treat the at least some soft oral tissues of the user.

Description

Title: Liqhtsource for Soft Oral Tissue

FIELD OF THE INVENTION

This invention relates to electromagnetic radiation devices for providing electromagnetic radiation to the soft oral tissues of a user, together with treatment methods useful therewith.

BACKGROUND OF THE INVENTION

Therapy using electromagnetic radiation involves the application of energy to biological tissue for the purpose of stimulating biological functions or substantially reducing or eradicating microflora. Electromagnetic radiation can also be used to activate an ingredient, which may be or comprise a photosensitizer; that has been applied to the biological tissue. Although the exact mechanisms of action of such therapy are not known with certainty, the therapy is a well established treatment for a variety of ailments. Therapy using electromagnetic radiation has been used to treat soft tissue maladies such as capsulitis, bursitis, sprains, strains, hematomas and tendinitis, acute and chronic joint problems such as osteoarthritis, rheumatoid arthritis and ligament and tendon injuries, tendinitis, arthritic pain, chronic pain such as post herpetic neuralgia, chronic back and neck pain, metatarsalgia, trigeminal neuralgia, brachial neuralgia, plantar fisciitis, cellular damage, in vitro fertilization enhancement, stimulation of embryogenesis, soft tissue injury, aging skin, seasonally affected disorder, inflammation, fine lines and wrinkles, mucositis, frozen shoulder, temporomandibular joint diseases and disorders (TMJ) and carpal tunnel syndrome. Therapy using electromagnetic radiation has also been used to treat non-union and small bone fractures, herpes, apthous ulcers, leg ulcers, dermatitis, wound healing, burns, acute epididymitis, otorhinolaragngology, gynecology, obstetrics, superficial AP stimulation and tonification, cosmetic imperfections, cellulite, and acne, among other things. Oral microorganisms are the cause of many undesirable conditions including periodontitis and halitosis (i.e. bad breath). Periodontitis is associated with colonization of predominantly Gram-negative microorganisms, including the black-pigmented anaerobes Porphyromonas gingivalis and Prevotella intermedia. Halitosis is typically a consequence of volatile sulphur compounds (VSC). VSCs are produced by oral anaerobic Gram-positive bacteria by degradation of sulphur containing proteinaceous substrates in the saliva. The VSCs are released into the oral environment where they are mixed with air expired from the lungs resulting in a unpleasant oral odour. The above mentioned proteinaceous substrates may come from the intake of foods, such as meat, fish, spices, vegetables, dairy products, etc. Volatile Sulphur Compounds such as, for instance, diallyl sulfide (a thioether), can be found in garlic, which is known to cause bad breath.

Current antimicrobial treatment for periodontitis often is invasive and painful and involves a combination of scaling and root planing (SRP) and either systemic or locally delivered antibiotics, as well as surgery. Although a proven therapy, mechanical removal of calculus with its associated biofilms is laborious, does not completely eliminate offending microorganisms, and may predispose the patient to bacteremia. Furthermore, continued use of antibiotics may prompt the development of resistant bacterial strains. In an effort to bypass these problems, alternative methods of antimicrobial treatment for periodontitis have been and are being investigated.

Typically, treatment or therapy using electromagnetic radiation involves radiating energy onto or into a user's skin. The radiation is typically applied at wavelengths either in the visible, ultraviolet, radiofrequency, or the infrared range. A wide variety of radiating electromagnetic radiation sources are available and known in the art. The radiating electromagnetic radiation sources used in these therapies radiate energy at a wide variety of wavelengths with different wavelengths having been found to be useful depending on the ailment being treated. There are devices known in the art that direct electromagnetic radiation to the teeth for such purposes as whitening and general dental hygiene.

Other devices are used for imaging the teeth or for making impressions of teeth. None of these devices are adapted to specifically direct electromagnetic radiation to the soft oral tissues of a user.

SUMMARY OF THE INVENTION

According to one aspect of the invention there is provided a device that can provide electromagnetic radiation to the soft oral tissues of a user, such as the labial and lingual gums, the hard and soft palate, the tongue, the inner lips including the buccal mucosa or inner cheeks, and the upper throat.

According to an embodiment of the present invention, the device for providing electromagnetic radiation to a desired soft oral tissue of a user can comprise (i) a body for disposing in the mouth of a user, (ii) a stem connected to the body for placing the device in a user's mouth, the stem being separated from the body by a distance such that the body can be located next to the gums of a user while the stem protrude's from the user's mouth, and (iii) an electromagnetic radiation source for delivering radiation of a desired wavelength, said radiation source being disposed on or within the body in a position for delivering said radiation to desired soft oral tissues. The body can be generally arc shaped, and have an inner wall and an outer wall. The electromagnetic radiation source can comprise at least one of light emitting diodes (LEDs), chips from LEDs, miniature xenon lamps, diode lasers, diode laser chips, lasers, oled or fiber optic lights, and heat emitting elements, which can be embedded in or encapsulated by a translucent material. The electromagnetic source and the substrate can be covered by a translucent material, such as silicone. The device can further comprise a protrusion extending for at least a portion of the substrate around the outer wall, the protrusion being suitable for resting against inner gums of the user during use of the device. According to another embodiment of the present invention, the device can further comprise temperature sensing device disposed on the body for - A -

determining the temperature of the soft oral tissue and/or of the body. The temperature sensing device can provide data to a processor which can automatically shut down or decrease the power to the electromagnetic source.

According to another embodiment of the present invention, the device can further comprise a cooling mechanism disposed on or within the body.

The cooling mechanism can include tubing for transporting a cooling solution proximate to the electromagnetic radiation source and/or the soft oral tissues.

The tubing can be embedded within and/or attached to the translucent material, and can be used to transport cooling solutions such as water. The cooling mechanism can receive instructions from a processor to increase or decrease the rate of cooling based on data received by the processor from a temperature sensing device.

According to another embodiment of the present invention, methods of using the device are provided. For example, a method of using the device of the present invention for treating gingivitis of the soft oral tissues of the user is provided, the method comprising the steps of (i) placing the device so that the electromagnetic radiation source is located proximate the soft oral tissues of the user; and (ii) providing power to the electromagnetic source for a selected length of time. BRIEF DESCRIPTION OF THE DRAWINGS

The skilled person in the relevant arts will understand that the figures, described below are for illustration purposes only. The figures are not intended to limit the scope of the invention in any way.

Figure 1 is a perspective view of a device according to an embodiment of the invention.

Figure 2 is a sectional view of the device shown in Figure 1 disposed in the mouth of a user, as viewed along lines 2-2.

Figure 3 is a plan view of a device according to an embodiment of the invention. Figure 4 is a plan view of a device according to an embodiment of the invention.

Figure 5 is a side view of a device according to an embodiment of the invention. Figure 6 is a side view of a device according to an embodiment of the invention.

Figure 7 is a sectional view of the device shown in Figure 6, as viewed along lines 7-7.

Figure 8 is a plan view of a device that can be used on a portion of the gums according to an embodiment of the invention.

Figure 9 is a plan view of a device according to an embodiment of the invention.

Figure 10 is a plan view of a device according to an embodiment of the invention. Figure 11 is a plan view of a device according to an embodiment of the invention.

Figure 12 is a plan view of a device according to an embodiment of the invention.

Figure 13 is a plan view of a device according to an embodiment of the invention.

Figure 14 is a plan view of a device according to an embodiment of the invention.

Figure 15 is a plan view of a device according to an embodiment of the invention. Figure 16 is a plan view of a device according to an embodiment of the invention.

Figure 17 is a plan view of a device according to an embodiment of the invention. Figure 18 is a perspective view of a device according to an embodiment of the invention.

Figure 19 is a plan view of a device according to an embodiment of the invention disposed in the mouth of a user. Figure 20 is a schematic view of a device according to an embodiment of the invention.

Figure 21 is a side schematic view of a device according to an embodiment of the invention.

Figure 22 is a photograph of a mold for making a device according to an embodiment of the invention.

Figure 23 is a schematic view of the circuits used by a device according to an embodiment of the invention.

Figure 24 is a photograph of a portion of a device according to an embodiment of the invention. Figure 25 is a photograph of the top of a device according to an embodiment of the invention.

Figure 26 is a schematic representation of a calibration system used to measure outputs of a device according to an embodiment of the invention.

Figure 27 is a graph showing temperature measurements obtained from a device according to an embodiment of the invention.

Figure 28 is a section view of a device according to an embodiment of the invention shown proximate to soft oral tissue.

Figure 29 is a sectional view of a device according to an embodiment of the invention. Figure 30 is a photograph of a user using a device according to an embodiment of the invention.

Figure 31 is a photograph of the top of a device according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION

Disclosed and illustrated generally at 20 in the Figures is a device for providing electromagnetic radiation to some or all of the soft oral tissues of a user. The soft oral tissues include the labial and lingual gums, the hard and soft palate, the tongue, the inner lips including the buccal mucosa or inner cheeks, and the upper throat. The radiation can, for example, be provided to the soft oral tissues for disinfective, therapeutic, preventative, or stimulatory reasons. The device can be used, for example, to treat gum disease, such as gingivitis and/or periodontal disease, increase speed and quality of tissue repair and wound healing by, for example, regenerating or increasing the production of collagen, reduce any pain and/or swelling associated with the oral soft tissues, halitosis, oral cancers, such as squamous cell carcinoma, oral candidosis, and oral lesions, such as canker sores or lesions resulting from chemotherapy or radiation therapy such as, for example, oral mucositis and/or oral candidosis.

Device 20 comprises body 18 and stem 24. Body 18 comprises one or more electromagnetic radiation sources 30 disposed at desired locations within a coating 22 for providing radiation at a desired wavelength, or a mixture of desired wavelengths, to a desired soft oral tissue of a user. Electromagnetic radiation sources 30 can be of any suitable type, such as one or more light emitting diodes (LEDs), LED chips, miniature xenon lamps, diode lasers, diode laser chips, lasers, oled or fiber optic lights, heat emitting elements. Generally, radiation source 30 can comprise any radiation source that delivers radiation at a wavelength and intensity suitable to have a beneficial effect on soft oral tissue. For example, electromagnetic radiation sources that deliver microwave energy, radiofrequency energy, ultraviolet, visible, or infrared energy, ultrasound, laser energy, light energy or electrical stimulation, can be suitable.

Electromagnetic radiation sources 30 may be electrically interconnected by wires (not shown) or connected to substrate 36. For example, leads from electromagnetic radiation sources 30 can be connected to substrate 36 and soldered at points 58 (shown in Figure 5). Substrate 36 can provide at least one mount for radiation sources 30. Substrate 36 can be a flexible circuit board, such as a flexible printed circuit board, and may be opaque, reflective, or transparent. For example, a transparent flexible printed circuit board can be formed from Mylar or other suitable material. Body 18 is generally arc-shaped to fit the gum-line of a user's mouth, or is generally flexible so that it can be formed into an arc-shape. Arc-shaped body 18 can have an inner wall and an outer wall spaced by a sufficient distance to fit over a user's gums. Substrate 36 can be generally flexible so that it can be placed in the desired shape manually, or it can be formed in the desired shape mechanically.

Stem 24 includes a power source connection 38, which provides an electrical connection from a source of power to radiation sources 30, either directly or through substrate 36. Power source connection 38 can be electrically connected to substrate 36 through joint 62. Alternatively, power source connection 38 and substrate 36 can be pre-formed from a unitary piece of material. Power source connection 38 can further comprise connector 40. Connector 40 can be of the plug and socket type, or other suitable type as known in the art. As shown in Figure 3, connector 40 can be removably connected to mate 44, which can be connected to cord 46. Cord 46 can be electrically connected to transformer box 48. Transformer box 48 can be electrically connected to standard electrical circuit 52 through power cord 50. Transformer box 48 can comprise means for transforming AC power obtained from standard electrical power receptacle 52 into power suitable for electromagnetic radiation source 30. Optionally, transformer box 48 can be replaced with a battery.

Optionally, power source connection 38 can be adapted for connection directly to transformer box 48 via connection means known in the art. For example, power source connection 38 can extend to a plug, or other connecting member, that can plug into transformer box 48 without the use of connector 40. Connector 40 can optionally comprise on-off switch 42, as shown in Figure 1 , which allows the user or trained personnel to conveniently turn the device on or off while the device is placed in a user's mouth and the user is comfortable, without having to change positions to reach the switch. Alternatively, on/off switch 54 can be located on transformer box 48, as shown in Figure 3.

Transformer box 48 can further comprise a processor 100 or timer for controlling electromagnetic radiation sources 30. Treatment protocols can also be controlled by the processor, as described further below. Figure 4 shows another embodiment of device 20 where at least one battery 39 is disposed within stem 24 for providing power to radiation source 30.

Coating 22 comprises material that is generally translucent, that is, capable of allowing the transmittance of radiation provided by electromagnetic radiation source 30. For example, the material can be silicone, for example, medical grade silicone. The material should be generally flexible or moldable so that it can be conformed to soft oral tissue. The material can be stable to sterilization procedures, preferably repeated sterilization procedures, such as those including an autoclave, gas, radiation, and/or chemical disinfectant. It is preferred that the material maintains its integrity for at least ten, more preferably, fifteen, even more preferably twenty-five treatments with an autoclave. It is preferred that body 18 is substantially covered by coating 22 to provide comfort to the user when the device is positioned next to the gums, and to protect the electrical connections and radiation source 30. Stem 24 is attached to body 18, and can generally be handled by a user in order to place body 18 next to the gums. Stem 24 can comprise coating 56, which can comprise the same materials as coating 22, and/or can comprise other materials that impart different properties to coating 56. For example, coating 56 can comprise a material which is more resilient to frequent contact with the user's hands. Coating 56 need not allow the transmittance of radiation from electromagnetic radiation sources 30. Coating 56 can extend outside of the outer lip of the user to protect the user from any electrical connections. Stem 24 can appear anywhere perimetrically along body 18, so long as the user can comfortably place and/or hold the device in his mouth, while allowing stem 24 to protrude from his mouth. Coatings 22 and 56 can be formed and/or applied to the other components of device 20 described herein by manufacturing methods known, or those that will be known, in the relevant arts, such as molding or injection molding. They can be formed together, or formed separately and joined later through methods known in the art. The size and shape of device 20 should be suitable to conform in one embodiment against at least a portion of the labial gums of a user, as shown in Figure 2. Device 20 is intended to direct electromagnetic radiation to desired soft oral tissue of the mouth, such as the labial gums. Device 20 can be held in place as a result of pressure from the inner lips or inner cheeks of a user, which holds device 20 in a position such that the energy transmitted by electromagnetic radiation sources 30 can reach at least a portion of the user's gums. Device 20 can be pre-formed into a suitable shape, or it can comprise materials that allow device 20 to be flexible enough to be conformed to at least a portion of the user's gums. Device 20 can be manufactured in different sizes, such as large, medium, or small, so that it is suitable for different mouth sizes, such as adult or children's mouths.

In various embodiments of the present invention, the plane defined by body 18 is displaced from the plane defined by stem 24 by distance 63, as shown in Figure 5 (planes are shown as dashed lines). Distance 63 can be selected according to the size and shape of the typical user's mouth and the particular location of the soft oral tissue to be treated. Distance 63 is used to ensure that body 18 is placed coincident to the soft tissue of the user, such as the gums, and not the hard tissue of the teeth. Such a shape allows the user to hold body 18 against either the top or bottom gums, depending in which way device 20 is oriented, with pressure from the inner lips, while allowing stem 24 to comfortably protrude from the user's mouth. Other suitable means of holding the device in place during use include protrusion 25, which protrudes completely or partially around the perimeter of body 18, as shown in Figures 6 and 7. Protrusion 25 can be preformed using coating 22 or other suitable material. Protrusion 25 rests against the inner lips of the user when the device is in place, and aids in maintaining the placement of radiation sources 30 next to the gums during treatment.

In other embodiments of the invention, the device can be configured so that radiation is transmitted to a selected portion of a user's soft oral tissue. Device 20a, as shown in Figure 8, comprises body 18a and substrate 36a, which extends over only a portion of the gums closest to stem 24. If it is that portion of gums that would benefit from exposure to radiation from electromagnetic radiation sources 30, then device 20a allows energy to be applied specifically to that portion. Figure 9 shows device 20b, which comprises body 18b. Body 18b comprises substrate 36b which extends substantially to the back of a user's mouth on one side. Electromagnetic radiation source 30 is located near the back of the mouth of the user, thereby demonstrating another means of providing radiation to a selected portion of the gums.

Figure 10 shows another means for providing radiation to selected portions of the gums. Block 60 is applied to certain areas of body 18 in order to block the radiation from being emitted from those areas. Block 60 comprises a material that does not allow the transmittance of the energy from electromagnetic radiation sources 30, and can comprise a reflective material.

Block 60 can be a medical grade tape suitable to be used in the mouth, for example, or may be a pre-formed piece having an inner diameter greater than the outer diameter of body 18 such that it can slide onto body 18 and be placed in the desired location.

In some cases, it is desirable to provide radiation to the inner lips and/or inner cheeks of the mouth as well as the labial gums. Figure 11 shows a suitable configuration for such a use. Device 20c comprises body 18c and substrate 36. Electromagnetic radiation sources 30 are located on the side of substrate 36 directed to the labial gums, and also on the side of substrate 36 directed to the inner lips of the user. Such a configuration allows treatment or prevention of ailments afflicting the inner lips and/or inner cheeks, as well as the labial gums, for example. The devices of the present invention can further comprise at least one temperature sensing device disposed on or within body 18, such as temperature sensing device 90 shown in the figures, for measuring the temperature and/or any change in temperature at the device-soft oral tissue interface. Temperature sensing device 90 can comprise, for example, a thermal conductive material, such as copper metal or other thermal interface material, and a thermal transducer, such as a p-n junction diode or thermistor. The thermal conductive material can extend from the device-soft oral tissue interface and/or can be located near the outer surface of coating 22. The thermal conductive material can be in communication with the thermal transducer. The thermal transducer can be in communication with a processor disposed in transformer box 48. The configuration of electromagnetic radiation sources 30, and temperature sensing device 90 (if used) can also be implemented on a PCB or other structures functionally equivalent thereto. In other embodiments not shown, temperature sensing devices can be disposed at various selected locations along body 18.

Device 20 can further comprise a mechanism for cooling the gums, either continuously throughout the treatment, periodically for preselected time periods, or upon receiving a signal that the soft oral tissue and/or area surrounding it has passed a preselected temperature. Figure 12 shows an embodiment of the device having a cooling mechanism disposed on or within body 18. The cooling mechanism may comprise tubing 37 disposed outside of or within coating 22, for circulating a cooling solution around the treatment area. The cooling solution can comprise water, a coolant, a chiller or any suitable substance as is known or will be known by those with skill in the relevant arts. Tubing 37 can comprise inlet 41 and outlet 43, whereby the cooling solution can be introduced through inlet 41 and can exit through outlet 43. The cooling mechanism can include a pump or solution source (not shown) which is manually controlled, or which is operated upon receiving commands from a processor, such as the processor disposed in transformer box 48. For example, a water source located in a dental or medical office can be adapted to provide water, such as cool or cold water, through inlet 41. In various embodiments, a thermal electric cooler could be employed. The rate of cooling can be adjusted based on the temperature sensed by temperature sensing device 90. For example, if the temperature sensed by temperature sensing device 90 reaches a predetermined temperature and it is decided that the temperature should be decreased, the rate of cooling can be increased until an acceptable temperature is reached. The rate of cooling can be adjusted automatically upon receiving instructions from the processor. Alternatively, the data from temperature sensing device 90 can be read by a person who adjusts the cooling mechanism accordingly to either increase or decrease the effect of the cooling solution.

Figure 13 shows device 70 which comprises device 20 and lingual body 72. Lingual body 72 is connected to body 18 through links 76. Lingual body 72 comprises substrate 74, which can be electrically connected to substrate 36 through links 76. In other embodiments, the electrical connection can be provided around the back of the teeth at the rear of the user's mouth through connection 75, as shown in Figure 14. Substrate 74 can be electrically connected to additional electromagnetic radiation source 30, which provide radiation to the lingual gums. Links 76 are insulated to protect the user from being exposed to any electrical current. Links 76 can fit over the teeth and can be shaped such that body 18 and lingual body 72 are biased towards one another. Such a bias allows lingual body 72 to sit comfortably next to the lingual gums. Figure 15 shows another embodiment of the present invention where electromagnetic sources 30 are also directed to the inner lips and/or inner cheeks of a user. Figure 16 shows another embodiment of the present invention for providing electromagnetic radiation to the soft oral tissue of the tongue and/or roof of the mouth. Device 96 comprises electromagnetic radiation sources 30 electrically connected to circuit board 92. Circuit board 92 can be sufficiently flexible so that the device can fit comfortably on the tongue or substantially wrap around the tongue. For example, circuit board 92 can comprise materials such as Mylar or other materials as known or as will be known in the art. Circuit board 92 can comprise materials that are transparent, reflective, and/or opaque.

It may be desirable to irradiate the soft oral tissues in the whole oral cavity concurrently, in which case a combination of the devices disclosed herein can be used. For example, as shown in Figure 17, devices of the present invention intended to irradiate the soft oral tissue such as the gums, roof of the mouth and tongue can be designed to be used concurrently. Alternatively, devices of the present invention can be manufactured together as a unitary piece, such as unitary piece 98 shown in Figure 18. Such whole mouth irradiation may aid in preventing downstream infections.

The devices of the present invention can further comprise radiation reflectors, diffusers, and/or enhancers. These features can contribute to the structure of the radiation source arrays, and may enhance or improve the effects of the radiation. For example, a copper strip can be disposed between radiation sources 30 and substrate 36 and be used to reflect radiation. A colour, such as the colour white, can also be used advantageously reflect radiation. Radiation enhancers and/or diffusers can be diffused throughout coating 22. A diffuser may be placed over the radiation source.

The devices of the present invention can be used in conjunction with one or more photosensitizers or other materials suitable for use with electromagnetic radiation. For example, photosensitizers can be used, such as those chosen from toluidene blue, methylene blue, arianor steel blue, tryptan blue, crystal violet, azure blue cert, azure B chloride, azure 2, azure A chloride, azure B tetrafluoroborate, thionin, azure A eosinate, azure B eosinate, azure mix sice, azure Il eosinate, haematoporphyrin HCI, haematoporphyrin ester, aluminium disulphonated phthalocyanine, chlorins, photoactive fullerenes (e.g. C16-b), aminolevulinic acid (ALA), and mixtures thereof. The devices can also be used with photodynamic therapeutic agents, such as porphyrins, for treatment of oral cancers, for example. The photosensitizer can be applied to the soft oral tissues of the gums as a solution, rinse, or gel, for example, before treatment with device 20 begins. For example, the light intensity provided by device can be about 100 mW/cm² and the irradiation time can about 100 seconds so that a light dose of at least 10 J/cm² is delivered.

During treatment, a device of the present invention can be placed in the desired location in the mouth, proximate to soft oral tissue, and in such a manner that at least one electromagnetic radiation source 30 is positioned to provide a sufficient amount of radiation to the selected area of the tissue to provide therapeutic or preventative benefit to the user.

Depending on the treatment, the radiation can be provided as light energy from, for example, a light emitting diode, the light having a peak wavelength ranging from about 400 to about 1000nm, or from about 500 to about 800 nm, or from about 600 nm to about 730 nm, or from about 610 nm to about 690 nm, or from about 620 nm to about 640 nm, or from about 650 nm to about 680 nm, or from about 400 to about 430 nm. For example, electromagnetic radiation source 30 with a peak wavelength of about 624 nm and a spectral width of about 18 nm can be used for the treatment of gingivitis. The wavelength can be selected to match the absorption profile of an applied photosensitizer or an endogenous photosensitizer, such as bacteria. The intensity of the light used can range from about 1 mW/cm² to about

300 mW/cm², or from about 5 mW/cm² to about 200 mW/cm², from about 10 mW/cm² to about 150 mW/cm², from about 25 mW/cm² to about 100 mW/cm², or from about 95 mW/cm² to about 105 mW/cm², or from about 50 mW/cm² to about 100 mW/cm². The light dose used can range from about 1 J/cm² to about 300 J/cm², or from about 2 J/cm² to about 200 J/cm², or from about 2 J/cm² to about 100 J/cm², or from about 2 J/cm² to about 60 J/cm², or from about 2 J/cm²to about 30 J/cm², or from about 6 J/cm² to about 25 J/cm², or from about 6 J/cm² to about 12 J/cm². The light dose can be administered for a length of time such that the total light dose received by the soft oral tissues is up to 100 joules per use.

EXAMPLE 1

The objective of this project was to develop a soft oral tissue illuminator that can deliver optical energy of 50-100 mW/cm² for about 20 minutes to the gingiva tissue.

The Device

Small LED chips embedded in silicone material were used. The concept is shown in Figure 19. The criteria used to source the LED chips included (i) high power, (ii) peak emission wavelength around 630 nm, (iii) easy to solder and to make a prototype in the laboratory, and (iv) can be molded into silicone material. Advanced Power TOPLED product model LA G67F made by OSRAM was used. It was in a 3x3 mm PLCC-6 surface mount package. Peak emission wavelength was 624 nm with spectral width of 18 nm. It produced output optical power of 40 mW with a viewing angle of 120 degrees. Other suitable models include LR G6SP, which has similar specs but a peak emission wavelength of 632 nm.

To protect the LED chips from contacting mouth tissue, the whole LED- based circuit was embedded in silicone. The following medical grade silicone material was used: Manufacturer: NuSiI Technology LLC, California, USA

Product No.: MED-6010

Color: optically clear

Refractive Index: 1.428

Curing: room temperature or heated up to 150⁰C Grade: FDA approved for less than 29 days human implantation

This material can be cured at room temperature.

A two-part aluminum mold was designed. As shown in Figures 20 and 21 , the arc-shaped portion is fashioned to be inserted into a user's mouth proximate to the user's gums and the straight portion is fashioned to protrude from the user's mouth in order to carry the electrical connections. Figure 22 shows a picture of the mold parts.

This device was designed to be flexible in order to facilitate being inserted into a user's mouth. A flex circuit was designed with twenty-three

LED chips in parallel arrangement as shown in Figure 23. Thus, if any one

LED is damaged or disconnected, the other LEDs will still be working. The material used for the flex circuit was half ounce copper. The prototype circuits were made by Gold Phoenix Printed Circuit Co. Ltd., China. In the end of the circuit was a high power 2-pin connector: one pin for +V and the other for ground. The requirement for the power supply was 2.4 V and 23 x 200 mA=4.6 A of current. In this experiment, a bench top lab-grade adjustable power supply was used for easy change and reading of driving current value.

The flex circuit with LED chips mounted is shown in Figure 24. Figure 25 shows the complete soft oral tissue illuminator with the flex circuit embedded.

Testing and Measurement

An integrating sphere-based optical power calibration system was used to measure the total output power of this whole mouth illuminator, as shown in Figure 26. The soft oral tissue illuminator used in this experiment had twenty- two working LEDs. At different driving currents, the total outputs were:

The power dropped with time because the semiconductor light emitting component was sensitive to temperature changes. As the temperature increased, the electrical-optical conversion efficiency decreased and more heat was generated, until it reached equilibrium.

Using a soft oral tissue illuminator with a total of nineteen LED chips, bench-top temperature measurements were taken while the driving current was increased. The results are shown in Figure 27. Because the temperature increased quickly, the measurement was stopped before the maximum driving current of 200 mA/chip was reached. This suggests that an active cooling mechanism would be beneficial to maintain a suitable temperature in the user.

Trials on Volunteers

Trials were conducted on adult human volunteers in order to (i) test the comfort levels of the users, (ii) measure the temperature change with the user's mouth, and (iii) measure the optical power delivered to the gum tissue.

Figures 28 and 29 show the locations of the soft oral tissue illuminator and temperature sensor, and Figure 30 shows the device disposed in the mouth. Spherical tip fiber optic probes and a multi-channel dosimeter were used to measure the optical power distribution (fluence rate) on the gum tissue, and along tongue and cheek tissue.

The results are as follows:

(1 ) LEDs driven at full power (200mA/chip): Fluence rate on the LED chip: 77mW/cm²

Fluence rate in between LEDs: 50mW/cm²

Fluence rate on tongue: 2-10mW/cm² Fluence rate at the corner of the cheek: 4-26mW/cm² Temperature reaches 45°C in about 1 minute. (2) LEDs driven at 60% full power (130mA/chip): Fluence rate on the LED chip: 67mW/cm² Fluence rate in between LEDs: 40mW/cm²

Temperature reaches 45°C in about 2 minutes.

In order to remove any heat generated by the LED chips within the illuminator, the illuminator was molded with a soft silicone tube embedded around the LED chips, as shown in Figure 31. Temperature measurements were made on an adult user's mouth with this water-cooled device.

Observations noted were:

(1) device on bench, water on (50ml_/minute), temperature dropped from 23.8°C to 22.O⁰C in 1 minute;

(2) device put in mouth, after 1 minute, temperature = 34.3°C;

(3) device still inside mouth, LEDs on (full power, 200mA/chip),

1 minute 38.7⁰C

2 minutes 39.9⁰C 3 minutes 40.1⁰C

4 minutes 40.3⁰C

5 minutes 40.5⁰C

6 minutes 40.7⁰C

7 minutes 40.9°C 8 minutes 41.0°C

9 minutes 41.1⁰C 10 minutes 41.2°C

11 minutes 41.2°C

12 minutes 41.2⁰C

13 minutes 41.2°C 14 minutes 41.2⁰C

15 minutes 41.2°C.

At the final temperature, the optical power of the device surface was about 70mW/cm².

The above detailed description is of the best presently contemplated mode of carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The scope of the invention is best defined by the appended claims.

Claims

What is claimed is:

1. A device for providing electromagnetic radiation to at least some of the soft oral tissues of a user, said device comprising

a substrate for disposing in the mouth of a user proximal to at least some of the soft oral tissues, and

an electromagnetic radiation source disposed on said substrate for delivering radiation of a desired wavelength to the proximal soft oral tissues.

2. The device according to claim 1 , wherein the substrate has at least one sidewall for positioning said radiation source proximal to the user's gums.

3. The device according to claim 1 wherein the substrate has opposing sidewalls for positioning said radiation source proximal to the user's inner and outer gums.

4. The device of claim 1 wherein the substrate has a tongue portion for positioning said radiation source proximal to the user's tongue.

5. The device of claim 1 wherein the substrate has opposing sidewalls for positioning said radiation source proximal to the user's inner and outer gums and a tongue portion for positioning the radiation source proximal to the user's toungue.

6. The device according to any one of claims 1-5, wherein the electromagnetic radiation source comprises at least one of light emitting diodes (LEDs), chips from LEDs, fluorescent lights, incandescent lights, arc lamps, quartz halogen sources, halogen lamps, sulfur lamps, flash lamps, neon lamps, xenon lamps, diode lasers, diode laser chips, lasers, oled or fiber optic lights, heat emitting elements, and filamentous lights.

7. The device according to any one of claims 1-5 wherein the electromagnetic radiation source comprises a plurality of LEDs.

8. The device according to any one of claims 1-7, further comprising a medical grade silicone coating disposed at least over the radiation source.

9. The device according to any one of claims 1-8, further comprising a stem extending from the substrate to protrude from the user's mouth.

10. The device according to claim 9, wherein said stem is sufficiently rigid to facilitate positioning of the substrate in the user's mouth.

11. The device according to claim 10, wherein said stem extends in a plane that is displaced sufficiently from said substrate to allow said stem to comfortably protrude from the user's mouth while said substrate remains properly positioned proximal to at least some of the soft oral tissues.

12. The device according to anyone of claims 1-11 , further comprising a processor for controlling the operation of the device.

13. The device according to claim 12, further comprising at least one temperature sensing device disposed on said substrate for sensing the temperature proximal to at least some of the soft oral tissues and communicating the sensed temperature information to said processor for processing.

14. The device according to claim 13, further comprising a cooling mechanism disposed on said substrate for cooling at least some of the soft oral tissues when said sensed temperature exceeds a predetermined amount.

15. The device according to any one of claims 1-13, further comprising a cooling mechanism disposed on said substrate for cooling at least some of the soft oral tissues.

16. The device according to any one of claims 1-15, further comprising a protrusion extending from the substrate for resting against the outer gums of the user during use of the device.

17. A method for treating at least some of the soft oral tissues of a user, said method comprising the steps of:

(i) placing a device in the mouth of a user proximal to at least some of the soft oral tissues, the device having an electromagnetic radiation source disposed on a substrate for delivering radiation of a desired wavelength to the proximal soft oral tissues, and

(ii) providing power to the electromagnetic radiation source to produce electromagnetic radiation at a desired wavelength for a selected length of time to treat the at least some soft oral tissues of the user.

18. The method according to claim 17, further comprising the step of applying a photosensitizer to at least some of the soft oral tissues.

19. The method according to claims 17 or 18 used for treating periodontitis.

20. The method according to claims 17 or 18 used for treating halitosis.