Oral hygiene system and method of using the same

Abstract

An oral hygiene device includes: a housing having an out-of-mouth portion and an in-mouth portion; at least one energy transfer element disposed in or on the in-mouth portion and configured to transfer energy to one or more teeth of a subject; a controller disposed in the out-of-mouth portion and electrically connected to the at least one energy transfer element; an energy storage unit disposed in the out-of-mouth portion; and a sleeve removably connected to the in-mouth portion of the housing, the sleeve having upper and lower channels configured to receive upper and lower teeth of the subject. Methods of using the oral hygiene device and methods of performing oral hygiene treatment are also described.

Description

[0001] Citations of Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 903,136, filed on September 20, 2019, the entire contents of which are incorporated herein by reference. Background Art

[0003] Treatments such as teeth cleaning, plaque removal, and bacterial treatments (e.g., bacterial infections, bad breath) typically require the subject to visit a dental professional to manually apply the treatment. Dental procedures require the subject to keep their mouth open while the practitioner performs the treatment. Such on-site cleaning is cumbersome, painful, and can cause anxiety, and is often expensive in terms of cost and time for the subject.

[0004] Home treatments for tooth cleaning are primarily directed to tooth whitening, and therefore typically use chemical agents, sometimes in combination with light or other stimulants. Such treatments are typically less effective than professional procedures because they use, for example, lower concentrations of cleaning agents or bleaching agents in order to reduce the risk of injury to the subject due to accidental misuse. As a result, such treatments typically take longer to achieve the same results as professional treatments. Furthermore, because existing tooth cleaning devices and methods are primarily directed to whitening, existing devices and methods may focus on the front teeth that are visible when the subject smiles, and may not effectively clean the back teeth or may not clean the back teeth at all.

[0005] It is well known that cleaning around dental braces is difficult, and adolescents, who comprise the majority of those who wear dental braces, are less likely to adhere to oral hygiene instructions. Poor oral hygiene can result in longer orthodontic treatment due to the need to pause and remove the wires for additional cleaning, and can lead to poor aesthetic results due to demineralization of tooth enamel, and can negatively affect gum health, among other things.

[0006] When using light therapy, energy can be applied arbitrarily to the light emitting devices, for example causing them to emit light when not properly positioned in the subject's mouth. This accidental activation of the light (which can often be quite bright) can cause discomfort and also result in a waste of energy.

[0007] Enforcing or monitoring subject compliance with a home dental care routine may also be difficult because existing devices do not track or record when they are used and for how long. Dental professionals who wish to monitor subject compliance with a treatment regimen may have no alternative other than asking subjects to self-report when and for how long they use a device.

[0008] Finally, existing home oral diagnosis and treatment devices are complex and require frequent cleaning and disinfection after use. For example, the device in U.S. Patent Application No. 10 / 944,740, filed on September 21, 2004 and incorporated herein by reference, is constructed as a single-piece and has a power supply connected to a mouthpiece, wherein the mouthpiece has a light-emitting element for whitening teeth. The device in U.S. Patent Application No. 11 / 579,916, filed on March 16, 2005 and incorporated herein by reference, is another example of a device constructed as a single-piece, which has an electronic device and a light source for being located in the mouth of a subject. Cleaning such a device may be difficult because water may accidentally enter the interior of the housing and interfere with the electronic device. In addition, due to the size variation of the mouth, the single-piece device must be tailored to the subject, otherwise it will result in a non-optimal fit.

[0009] Therefore, there is a need in the art for an inexpensive, home-use effective oral care device that can be used by people wearing dental braces and has a safe, effective compliance monitoring system and can be customized to fit multiple subjects optimally. The present invention satisfies this need. Summary of the invention

[0010] In one aspect, an oral hygiene device includes: a shell having an outside-mouth portion and an inside-mouth portion; at least one energy transfer element disposed in or on the inside-mouth portion and configured to transfer energy to one or more teeth of a subject; a controller disposed in the outside-mouth portion and electrically connected to the at least one energy transfer element; an energy storage unit disposed in the outside-mouth portion; and a sleeve removably connected to the inside-mouth portion of the shell, the sleeve having upper and lower channels configured to receive the upper and lower teeth of the subject.

[0011] In one embodiment, the device further comprises at least one control element disposed on the outer portion of the mouth. In one embodiment, the device further comprises a wireless communication interface electrically connected to the controller and configured for communication between the controller and a computing device external to the oral hygiene device. In one embodiment, the device further comprises at least one indicator element disposed in the outer portion of the mouth. In one embodiment, the indicator element is an LED. In one embodiment, at least one energy transfer element is a plurality of LEDs. In one embodiment, the LEDs are configured to emit light in the range of 200nm to 1500nm. In one embodiment, the LEDs are configured to emit light in the range of 400nm to 500nm. In one embodiment, the LEDs are configured to deliver at least 30mW / cm2 to the teeth of the subject. 2In one embodiment, the device further comprises a temperature sensor disposed in the intra-mouth portion and communicatively connected to the controller, wherein the controller is configured to interrupt treatment if the temperature measured by the temperature sensor exceeds a threshold value. In one embodiment, the device further comprises at least one environmental sensor disposed in the intra-mouth portion and communicatively connected to the controller, wherein the controller is configured to start treatment if at least one measurement value obtained from the at least one environmental sensor indicates that the oral hygiene device is located in the mouth of the subject. In one embodiment, the at least one environmental sensor comprises a light sensor. In one embodiment, the energy storage unit is a rechargeable battery. In one embodiment, the device further comprises a wireless charging system configured to charge the battery. In one embodiment, the sleeve comprises at least one reflective element. In one embodiment, the at least one energy transfer element is located in an occlusal plane of the teeth of the subject. In one embodiment, the at least one energy transfer element comprises: a first energy transfer element configured to transfer energy to a buccal side of the teeth of the subject; and a second energy transfer element configured to transfer energy to a lingual side of the teeth of the subject. In one embodiment, the at least one energy transfer element is configured to transfer pulsed energy to one or more teeth of the subject. In one embodiment, the energy transfer element is configured to transfer electromagnetic energy having a spectrum selected from the group consisting of gamma rays, x-rays, ultraviolet light, visible light, infrared light, microwaves, and radio waves.

[0012] In another aspect, a method of using an oral hygiene device includes applying a light-activated treatment material to the oral hygiene device; awaiting an indication that the oral hygiene device is ready to begin treatment; activating a control element on the oral hygiene device to begin oral hygiene treatment; inserting the oral hygiene device into a subject's mouth; awaiting an indication that treatment is complete; and removing the oral hygiene device from the mouth.

[0013] In one embodiment, the method further comprises the step of applying the sleeve to the oral hygiene device. In one embodiment, the method further comprises the step of obtaining a sleeve customized for the subject or selecting a sleeve from a set of standard sized sleeves to match the subject. In one embodiment, the method further comprises the step of charging an energy storage unit in the oral hygiene device.

[0014] In another aspect, a method of implementing oral hygiene treatment includes: waiting for a signal indicating that a device has been removed from a charger; providing an indication to a subject when the device is ready to begin treatment; receiving user input from the subject indicating the start of treatment; supplying power to one or more energy transfer elements at a first power level; waiting for one or more signals indicating, individually or in combination, that the device is in the subject's mouth; supplying power to one or more energy transfer elements at a second power level; waiting for a predetermined period of time; turning off one or more energy transfer elements; and providing an indication to the subject that treatment is complete.

[0015] In one embodiment, the predetermined time period is two minutes or less. In one embodiment, the method further comprises: monitoring a temperature measured by a temperature sensor located on the device; and shutting down one or more energy transfer elements when the temperature exceeds a threshold. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The foregoing objects and features and other objects and features will become apparent with reference to the following description and accompanying drawings, which are included to provide an understanding of the present invention and constitute a part of the specification, wherein like reference numerals represent like elements, and in the accompanying drawings:

[0017] Figure 1A It is an oral hygiene device;

[0018] Figure 1B It is an oral hygiene device and a disassembled removable liner;

[0019] Figure 1C is a perspective view of an exemplary oral hygiene device;

[0020] Figure 1D is a front view of an exemplary oral hygiene device;

[0021] Figure 1E is a rear view of an exemplary oral hygiene device;

[0022] Figure 1F is a right side view of an exemplary oral hygiene device;

[0023] Figure 1G is a left side view of an exemplary oral hygiene device;

[0024] Figure 1H is a top view of an exemplary oral hygiene device;

[0025] Figure 1J is a bottom view of an exemplary oral hygiene device;

[0026] Figure 2 It is an oral hygiene device;

[0027] Figure 3A is a detail view of the oral hygiene device;

[0028] Figure 3B is a view of an attachment mechanism for an oral hygiene device;

[0029] Figure 3C is a view of a removable liner of an oral hygiene device having a reflective element;

[0030] Figure 3D is a cross-sectional view of a removable liner of an oral hygiene device;

[0031] Figure 4 is an exploded view of the oral hygiene device;

[0032] Figure 5A is an exemplary oral hygiene device;

[0033] Figure 5B is a view of an exemplary oral hygiene device with a replaceable liner removed;

[0034] Figure 5C is a diagram of the light emission angle of an illumination device located on an oral hygiene device;

[0035] Fig. 6A is an exemplary oral hygiene device;

[0036] Figure 6B is a view of an exemplary oral hygiene device with a replaceable liner removed;

[0037] Figure 6C is a top view of an exemplary oral hygiene device;

[0038] Fig.6D is a cross-sectional view of a removable sleeve of an exemplary oral hygiene device;

[0039] Figure 7 It is a system diagram of the oral hygiene device;

[0040] Figure 8 is the method of the present invention;

[0041] Fig. 9 is an exemplary software diagram of an oral hygiene device; and

[0042] Fig.10 is an exemplary state machine diagram for an oral hygiene device. DETAILED DESCRIPTION

[0043] It should be understood that the drawings and description of the present invention have been simplified to illustrate the elements relevant to a clear understanding of the present invention, and for the sake of clarity, many other existing elements in the related systems and methods have been omitted. Those of ordinary skill in the art may recognize other elements and / or steps desired and / or required in the process of realizing the present invention. However, because such elements and steps are well known in the art, and because they are not conducive to a better understanding of the present invention, the discussion of such elements and steps is not provided herein. All such variations and modifications of such elements and methods known to those skilled in the art are disclosed herein.

[0044] Unless otherwise defined, all technical and scientific terms used in this article have the same meaning as those commonly understood by those of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, only exemplary methods and materials are described herein.

[0045] As used herein, each of the following terms has the meaning associated with that term's use in this section.

[0046] The articles "a" and "an" are used herein to refer to one or to more than one (ie, to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0047] As used herein, "about" when referring to a measurable value (such as an amount, a duration, etc.) is intended to encompass deviations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value, so long as such deviations are appropriate.

[0048] Throughout this disclosure, various aspects of the present invention may be presented in the form of a range. It should be understood that the description in the form of a range is only for convenience and brevity, and should not be interpreted as a hard limit to the scope of the present invention. Therefore, the description of the range should be considered to have all possible sub-ranges and single values ​​of the specific disclosure within the range. For example, the description of a range such as 1 to 6 should be considered to have a specific disclosed sub-range within the range, such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and have a single value, such as 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any full increment and partial increment may be present between them. This applies regardless of the size of the range.

[0049] In some aspects of the invention, software executing the instructions provided herein may be stored on a non-transitory computer-readable medium, wherein when executed on a processor, the software performs some or all of the steps of the invention.

[0050] Aspects of the present invention relate to algorithms executed in computer software. Although some embodiments may be described as being written in a specific programming language, or executed on a specific operating system or computing platform, it should be understood that the system and method of the present invention are not limited to any specific computing language, platform, or combination thereof. The software executing the algorithm described herein can be written, compiled, or interpreted in any programming language known in the art, including but not limited to C, C++, C#, Objective-C, Java, JavaScript, Python, PHP, Perl, Ruby, or Visual Basic. It should also be understood that the elements of the present invention can be executed on any acceptable computing platform, including but not limited to servers, cloud instances, workstations, thin clients, mobile devices, embedded microcontrollers, televisions, or any other suitable computing devices known in the art.

[0051] Portions of the present invention are described as software running on a computing device. Although the software described herein may be disclosed as operating on a particular computing device (e.g., a dedicated server or workstation), it will be understood by those skilled in the art that the software is portable in nature, and for purposes of the present invention, most of the software running on a dedicated server may also be run on any of the following broadly included devices: desktop or mobile devices, laptops, tablets, smart phones, watches, wearable electronic devices or other wireless digital / mobile phones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

[0052] Similarly, portions of the present invention are described as communicating over various wireless or wired computer networks. For purposes of the present invention, the terms "network," "networking," and "networked" are understood to include wired Ethernet, fiber optic connections, wireless connections including any of the different 802.11 standards, cellular WAN infrastructure (such as 3G or 4G / LTE networks), (BLE) or A communication link or any other method by which one electronic device can communicate with another electronic device. In some embodiments, elements of the network portion of the present invention may be implemented over a virtual private network (VPN).

[0053] Aspects of the present invention relate to a light-activated antimicrobial system for oral hygiene. Figure 1A An exemplary device of the present invention is shown in FIG. Figure 1A, the device 100 includes a handle 101 directly connected to a neck 102 and includes an irradiation strip 103. In some embodiments, the handle 101, the neck 102, and the irradiation strip 103 are contained in the same housing, but in other embodiments, the handle, the neck, and the irradiation strip can be contained in multiple housings that can be removably connected to each other by, for example, a snap mechanism, one or more fasteners, magnets, or adhesives. One or more or all of these housings can be made of any suitable material, such as plastic (including but not limited to polyolefins, polystyrene, or nylon) or a cast material (such as polyurethane). Figure 1A Also shown is a disposable / replaceable sleeve 104 removably connected to the irradiation strip 103. The sleeve 104 is configured to receive the teeth of a subject, wherein the subject bites down on the sleeve. During use, some or all of the irradiation portion can be located in the subject's mouth, while the neck 102 and the handle 101 extend out of the subject's mouth. The sleeve 104 can include a variety of materials, such as a light-activated antimicrobial foam or a strip of light-activated therapeutic material disposed on the surface of the sleeve 104 that contacts the subject's teeth. In some embodiments, the sleeve 104 is custom-shaped for the subject's mouth or can be selected from a set of standard sizes to fit the subject. In some embodiments, the sleeve 104 is produced via additive manufacturing or molding.

[0054] The handle 101 may include one or more indicators or control elements 105. The element 105 may include an LED such as an indicator LED and / or may include a button, a switch, a dial, a digital display, a vibrating buzzer, a speaker, a buzzer, or any other suitable component electrically connected to the controller and configured to indicate the status of the device or accept user input for controlling the device. Exemplary status indications include, but are not limited to, treatment to be started, treatment completed, lighting system status or lighting system failure, charging status, charging completed, low battery, device in use, device not ready, treatment progress or stage, Bluetooth pairing, Bluetooth pairing successful, reminder to initiate treatment, general error, etc.

[0055] Exemplary control signals may include, but are not limited to, initiating Bluetooth pairing, starting treatment, turning the device on and off, checking battery charge level, adjusting light intensity, and initiating data transfer.

[0056] Reference now Figure 1B , another view of an exemplary oral hygiene device is shown. Figure 1BThe view of shows a separation state between the illuminator unit 100A (which includes a handle 101, a neck 102, and an irradiation bar 103) and a sleeve 104 that can be removed from the illuminator unit 100A. The irradiation bar 103 may include one or more light-emitting elements, such as LEDs. Various embodiments of the irradiation bar may include 1 to 200 individual LED elements or 1 to 100 individual LED elements. In some embodiments, the irradiation bar may include 20 to 40 LED elements. In some embodiments, the irradiation bar may include one or more flexible irradiation elements, such as flexible OLED elements configured to irradiate one or more teeth of a subject. In some embodiments, the irradiation bar may include fewer LED elements, wherein light is distributed on the teeth of the subject via one or more light pipes or other refractive or reflective elements located within the sleeve 104 or within the irradiation bar 103. In some embodiments, the sleeve 104 may additionally include one or more light-emitting elements, and the interface between the sleeve 104 and the irradiation bar 103 may include an electrical connection for providing power to the LEDs in the sleeve 104.

[0057] The illumination bar 103 may also include a transparent cover or lens over the LED elements, between one or more of the LED elements and the bushing 104. In some embodiments, the transparent cover or lens is disposed in direct contact with the bushing 104 when the bushing 104 is connected to the illumination bar 103. The cover may be overmolded or may be a separate piece that is removably or fixedly attached to the illumination bar 103. In some embodiments, the transparent cover or lens may include features or textures configured to disperse or diffuse light from the LED elements.

[0058] The bushing 104 can be made of any suitable material, but in some embodiments these materials include silicone, thermoplastics, polyolefin elastomers (POE), polyurethane, styrene-ethylene-butadiene-styrene copolymer (SEB), styrene-ethylene-propylene-styrene copolymer (SEPS), liquid silicone rubber (LSR), or a combination thereof. In some embodiments, the bushing may include ethylene-vinyl acetate copolymer (EVA) or a light-curable resin. In some embodiments, the bushing may be transparent or substantially transparent to light within some wavelength ranges (e.g., blue light). In some embodiments, the bushing may be made of a material that is transparent to light within the range of 200-1500nm, 300-780nm, 400-500nm, 425-475nm, or 440-460nm. In some embodiments, the bushing may be made of a material that is transparent to all visible light. In some embodiments, the bushing may be made of a material that is transparent to all visible light and / or infrared or ultraviolet light. In some embodiments, the bushing may be made of a material that is translucent to all visible light and / or infrared or ultraviolet light.

[0059] In some embodiments, the sleeve 104 can include a light-activated treatment material, such as an antibacterial or antimicrobial foam, including but not limited to Japanese Aster (Knotweed). The material can include a natural or synthetic photosensitizer or a photoactive natural extract that produces an immediate antimicrobial effect when exposed to light. In other embodiments, the foam can be added to the sleeve 104, such as applied to the sleeve 104 prior to treatment. The sleeve 104 can be made of a material that resists discoloration from contact with the foam. The foam can be configured to reduce plaque formation in a dental appliance worn on the buccal side of a patient's teeth, and / or can advantageously reduce gingivitis, gingival swelling, prevent caries, or prevent enamel demineralization.

[0060] In some embodiments, the sleeve 104 can have a durometer hardness of Shore A20 to Shore A70, or Shore A40 to Shore A60. In some embodiments, the sleeve 104 can be manufactured so that its shape remains unchanged after repeated application of force by the subject's teeth. In some embodiments, the sleeve 104 can include a deformable material that deforms and maintains the deformed shape after the subject's teeth apply a fixed force. In some embodiments, the sleeve can be configured for use with a denture or an orthodontic appliance.

[0061] Reference now Figure 1C to Figure 1J , showing multiple views of an exemplary oral hygiene device.

[0062] Reference now Figure 2 , showing another view of the oral hygiene device. Figure 2 An illumination strip having an outer surface 202 and an inner surface 201 is shown in detail, wherein the inner surface 201 is in contact with the liner 104. In some embodiments, the inner surface 201 includes a transparent lens or cover as generally discussed above. The illumination strip may include one or more illumination elements (e.g., LEDs) positioned along the illumination strip and outward from the inner surface 201 toward the liner 104. In some embodiments, the illuminator unit 100A and / or the liner 104 may include additional light emitting elements, light pipes, or reflective materials configured to illuminate the lingual side of one or more teeth.

[0063] exist Figure 2 The sleeve 104 shown in the figure includes a buccal side 203, a lingual side 204, and a middle surface 205. The surfaces 203 to 205 together define two channels configured to receive the upper and lower teeth of a subject. The sleeve and the channel can be substantially U-shaped as shown, or can be semicircular or oval in some embodiments. In some embodiments, the sleeve 104 can have a reflective material to disperse light to the lingual, buccal or chewing surfaces of the teeth and the interdental spaces between the teeth.

[0064] Reference now Figure 3A , shows a detail view of the device of the present invention, focusing on exemplary fastening elements for connecting the illuminator unit and the sleeve. The illuminator unit shown includes a tab 301 that is configured to mate with a slot (not shown) in the buccal side 203 of the sleeve 104. The tab 301 can be rigid or flexible, and can be more flexible, less flexible, or equally flexible than the sleeve 104. In some embodiments, the tab 301 is made of the same material as the transparent cover or lens of the illuminator unit. The tab 301 can be transparent, translucent, or opaque. In some embodiments, a single tab is used on each side of the illuminator unit to secure the sleeve 104 in place, but in other embodiments, multiple tabs may be used on each side, such as two or three tabs on each side. As shown in FIG. Figure 3A As shown, the tabs may be substantially rectangular, but may alternatively be cylindrical, semi-cylindrical, oblong or semi-oblong. The tabs 301 may have rounded or chamfered edges to facilitate insertion into the slots on the bushing 104.

[0065] exist Figure 3B , an alternative view of a tab / slot arrangement is shown in which the illuminator unit comprises two tabs 301 and the bushing comprises two corresponding slots 303. The slots 303 comprise a recessed portion 304 into which the tabs 301 fit when the illuminator unit and bushing are mated together, and a less recessed guide portion 305 which guides the tabs into the recessed portion during mating of the two parts.

[0066] The tab 301 and slot 303 can be designed so that the mating surfaces closest to the middle portion of the arch are intentionally made to interfere with each other. This interference causes the bushing and mouthpiece arch to be strained when the bushing and mouthpiece arch are assembled and causes the buccal side 203 (see Figure 2 ) and the inner surface 201 of the irradiated strip (see Figure 2 The resulting contact pressure provides a positive seal between the bushing and the mouthpiece arch.

[0067] refer to Figure 3C, shows a variation of a sleeve in which a reflective element 310 is located on the lingual side 204, the reflective element defining a proximal surface 311 and a distal surface 312. In various embodiments, either or both of the proximal surface 311 and the distal surface 312 can partially or completely reflect all or a portion of light in the visible spectrum, ultraviolet spectrum, and / or infrared spectrum. In one embodiment, the distal surface 312 is configured to be reflective so that light 313 provided, for example, by an attached illuminator unit can be reflected along a reflective path 314, for example to provide illumination to the inner surface (lingual side) of the tooth in addition to the buccal side. In one embodiment, the reflective element includes a reflective coating on the lingual side wall of the sleeve. In one embodiment, the reflective element can be overmolded into or onto a bracket. In one embodiment, the reflective element includes a reflective material, a woven material (e.g., a fabric), and / or one or more particles, such as spherical particles.

[0068] In some embodiments, the reflective element 310 may be deposited on the sleeve, for example via painting, adhesives, lamination, or heat sealing.

[0069] refer to Figure 3D , showing a cross-sectional view of an exemplary sleeve. In some embodiments, to maximize light transfer from the buccal / cheek side of the tooth, the sleeve can be configured such that the occlusal region 315 of the sleeve 310 is transparent or includes one or more light pipes, optical fibers, chopped optical fibers, or other materials to improve translucency through a portion of the bracket. In some embodiments, the occlusal region can include, for example, an overmolded transparent material bite plate, optically clear silicone, etc. In some embodiments, the occlusal region can include a bite plate that is translucent or configured to diffuse light. In some embodiments, the sleeve 310 includes one or more light pipes configured to direct the light path backward toward the lingual side of the tooth without the need for a separate reflective element.

[0070] exist Figure 4 An exploded view of an exemplary device of the present invention is shown in . The view shown shows a housing for a handle having two halves: an upper half 401 and a lower half 402, which can be connected together via snaps, one or more fasteners, adhesives, or any other suitable connection. The housing 401-402 encloses the electronics 403, which includes all appropriate electronics and control systems for the device, including but not limited to an energy storage unit, a controller unit, support circuits for the illumination element, charging circuits, indicator LEDs, human-machine interface inputs, data logging, data transmission, etc.

[0071] Electronics 403 are connected to illumination elements 405 via a flexible circuit board or wire bus 404. Flexible wire bus 404 can provide power and control signals to one or more illumination elements in illumination elements 405. In some embodiments, illumination element 405 is a flexible circuit board including one or more LEDs mounted thereon.

[0072] The illuminator unit housing comprises a tooth-facing half 408 and a lip-facing half 406, wherein the lip-facing half comprises a channel 407 through which the flexible wire bus 404 passes. Figure 4 In the illustrated embodiment, the illumination element 405 is mounted between a tooth-facing half 408 and a lip-facing half 406 of the illumination unit housing, with one or more LEDs facing the tooth-facing half.

[0073] In some embodiments, the device of the present invention includes an ambient light sensor (e.g., including a photodiode) mounted on a surface of the device that is typically located inside the subject's mouth during use. The controller can then periodically poll the ambient light measured by the ambient light sensor and turn off any LEDs or illumination elements in the illuminator unit when the ambient light sensor measures a level of ambient light above a predetermined threshold (thereby indicating that the illuminator unit is not located in the subject's mouth).

[0074] Suitable energy storage units include batteries, such as rechargeable or single-use batteries. In one embodiment, the energy storage unit is a rechargeable lithium polymer battery. In one embodiment, the battery is a lithium ion battery. In some embodiments, disposable alkaline batteries can be used. Suitable batteries can have a capacity of at least 100mAh, at least 150mAh, at least 200mAh, or at least 250mAh. In some embodiments, batteries suitable for use with the device support high discharge rates, such as 10C, 15C, or 20C. In some embodiments, in addition to or in place of batteries, the energy storage unit may include one or more capacitors or supercapacitors. In one embodiment, the device may include a charging system for rechargeable batteries, capacitors, or supercapacitors, the charging system including, for example, an outlet for receiving a battery charging cable. In some embodiments, the device of the present invention includes an inductive or wireless charging system configured to charge the energy storage unit when an energy receiving coil located in the device is close to an energy transmitting coil located in a separate wireless charging stand or pad.

[0075] Suitable controllers include embedded microcontrollers or systems on chip (SoC). The controller may include some non-transient computer readable memories having instructions stored thereon, and these instructions include one or more programs to be executed by the processor to execute the computer startup method for the present invention. The controller may include one or more wireless or wired communication interfaces, such as Bluetooth, WiFi or other wireless communication interfaces, so as to allow the device to be paired with a second external computing device (such as a smart phone). When the device has a controller configured to communicate with a second computing device, some or all of the computing operations performed by the controller can be allocated to the second computing device to be processed or calculated on the second computing device. In some embodiments, the controller can be configured to be wirelessly connected to a remote computing device so that usage and / or other data are transmitted to the remote computing device.

[0076] refer to Figure 5A and Figure 5B , another embodiment of the device includes an illumination element 501 located on the occlusal plane of an occlusal bracket 502, which is removably located inside a sleeve 503. In the device shown, the light propagation can be changed by the physical placement of one or more light-emitting elements on the occlusal plane to adjust the light emission angle of the light source, for example, using interchangeable lenses, or using different sleeve materials or geometries to scatter, focus or redirect the light. The illumination element 501 may also include a transparent cover or lens located above the illumination element between the one or more LED elements and the sleeve 503. In some embodiments, when the sleeve 503 is connected to the illumination element 501, the transparent cover or lens is arranged to be in direct contact with the sleeve 503. The cover can be overmolded or can be a separate piece that is removably or fixedly attached to the illumination element 501. In some embodiments, the transparent cover or lens can include features or textures configured to disperse or diffuse the light from the illumination element. In some embodiments, one or more surfaces of the sleeve 503 (e.g., the proximal (inner) surface of the buccal portion 504 and / or the distal (outer) surface of the lingual portion 505) may include a reflective material to direct more light toward the surface of the tooth.

[0077] Figure 5C Shows Figure 5A and Figure 5B A cross-sectional view of an embodiment in FIG. 1 shows the light emission angle of the illumination element from the occlusal plane.

[0078] Fig. 6A , Figure 6B , Figure 6C and Fig.6DAnother embodiment of the device is shown in . The device shown includes an irradiation device 601, which has a buccal portion 603 and a lingual portion 604, and active irradiation elements are located on both of them. The first group of irradiation elements are located on the proximal (inner) surface of the buccal portion and are configured to irradiate at least the buccal side of the subject's teeth. The second group of irradiation elements are located on the distal (outer) surface of the lingual portion and are configured to irradiate at least the lingual side of the subject's teeth. The buccal portion and the lingual portion are connected by two bridging portions 605, which include one or more conductive elements (not shown) embedded therein to transmit power and / or control signals from a power source to the irradiation elements on the lingual portion, and the power source may be located in a handle 606 in some embodiments.

[0079] Figure 6C Shows Fig. 6A and Figure 6B . Arrows show exemplary illumination paths from illumination elements located in the buccal portion 603 and lingual portion 604 of the device.

[0080] In one embodiment, for FIG. 6A to FIG. 6C Removable / replaceable sleeve for use with the device ( Fig.6D ) may be configured as a clamshell structure having an upper portion 611 and a lower portion 612 that may be connected via a hinge in some embodiments, or may alternatively be configured as two separate pieces that snap together to enclose the portion of the irradiation device that is located within the user's mouth, such as Fig. 6A In some embodiments, Fig.6D The sleeve includes one or more reflective elements that further direct illumination of the tooth, as discussed elsewhere herein.

[0081] Reference now Figure 7 , shows a system diagram of an exemplary device of the present invention. The system diagram shown is divided into a charger / stand 701, a mouthpiece unit 702 and a sleeve 703. Note that Figure 1B The device 100A is an example of a mouthpiece unit 702, and Figure 1B Bushing 104 is an example of bushing 703 .

[0082] In the system diagram shown, the charger / stand 701 may include a charging power outlet, an electrical connection to the line voltage, and a socket for the mouthpiece unit. The electrical connection to the line voltage may be a connection to an AC power source, such as a main electrical connection, or alternatively may be a connection to a DC power source, such as a USB connection. In the case where AC power is used as a power source, the AC / DC converter may be incorporated into the charger / stand, or may be separated from the charger / stand, for example, using a wall AC plug adapter. The charging power outlet may be a physical connection point without a wired electrical connection (e.g., for a wireless charging system), or may alternatively include an electrical connection, such as a bare contact, a spring contact, or an electrical connector (e.g., a barrel-shaped power connector). Suitable wireless charging systems include, but are not limited to, a charging coil or an electrified connector with a magnetic attachment. In some embodiments, the charging coil may have a coil diameter of less than 30 mm, less than 20 mm, or 15 mm or less. In some embodiments, the wireless charging element may be capable of transmitting power at a rate of 250 mW, 500 mW, 1 W, or 2 W. In some embodiments, mouthpiece unit 702 and charging dock 701 may be configured such that it is physically impossible for mouthpiece unit 702 to electrically connect to charging dock 701 when the mouthpiece unit is located in the subject's mouth.

[0083] The charger / stand may also include a receptacle for the mouthpiece unit, for example to hold the mouthpiece unit in place for optimal wireless charging. The receiver provides a way to store the mouthpiece unit, allowing charging, conveying notifications to the user, and minimizing the risk of contamination of the mouthpiece unit. The charger / stand may also include a droplet catcher or small cavity positioned so that any fluid (water, saliva, etc.) dripping from the mouthpiece unit 702 will flow into it.

[0084] Mouthpiece unit 702 is subdivided into two subunits, subunit 702A is located outside the mouth, and subunit 702B is located inside the mouth. Subunits 702A and 702B can be physically and electrically connected to each other, wherein a portion of the mouthpiece unit extends from the subject's mouth when in use. Subunit 702A includes a charging power inlet that is configured to receive power from a charging power outlet in a charger / seat 701 via a wired and / or wireless connection. The charging power inlet is configured to receive power without exposing a live conductor that can discharge current in an unplanned manner. The charging power inlet can also be designed to be substantially smooth to prevent the growth of microorganisms, bacteria and / or fungi.

[0085] The energy storage unit may be included in the mouthpiece unit as discussed above.The input and notification system may include any or all of the control or indicator elements located on the mouthpiece unit, including but not limited to buttons, LED indicators, switches, etc. as discussed above.

[0086] The mouthpiece unit shown may include Bluetooth, WiFi and / or other wireless communication interfaces for communicating with an external computing device. In some embodiments, the Bluetooth interface in the mouthpiece unit may also include a Bluetooth host interface for connecting an auxiliary external sensor or indicator. In some embodiments, the Bluetooth interface can be connected to an application of a smart phone, for example, to collect data from the mouthpiece unit and send the data to the application of the smart phone. The Bluetooth interface may include a separate independent interface, or may be integrated into a system on a chip with a microcontroller. The Bluetooth interface may have a separate physical antenna, or may alternatively have an antenna integrated into the same package as the transceiver. The microcontroller may be any suitable microcontroller as discussed above, and in 702B, the light controller is electrically connected to a buccal or oral buccal light emitting element, which provides illumination to the teeth and gums. The illumination controller may include a fault detection system for detecting and reporting faults of the light emitting system. Exemplary fault detection systems include insufficient current / overcurrent monitoring, insufficient voltage / overvoltage monitoring, or ambient light sensing.

[0087] The interior mouth subunit 702B includes buccal or oral-buccal light emitting elements, which may be LEDs, OLEDs, or any other suitable illumination element as discussed above. The interior mouth subunit 702 may also include one or more sensors, such as temperature sensors, thermal sensors, infrared sensors, resistive sensors, environmental sensors, ambient light sensors, accelerometers, or sensors configured to monitor plaque accumulation, tooth discoloration, enamel health, gum health, or tooth movement of brace wearers. The minimum light intensity delivered to the face of the subject's teeth by the light emitting elements for use with the present invention may be selected, and the minimum light intensity delivered by the light emitting elements for use with the present invention may be configured, for example, to be at least 30 mW / cm 2 , at least 35mW / cm 2 , at least 40mW / cm 2 , at least 45mW / cm 2 , at least 48mW / cm 2 , at least 50mW / cm 2 , at least 60mW / cm 2 or at least 70mW / cm 2 The light emitting elements may be positioned so that they are 1.5 cm or less from the subject's teeth. When multiple discrete light emitting elements are used, the light emitting elements may be spaced 3 cm or less from each other, or 2 cm or less from each other. In some embodiments, one or more light emitting elements may be positioned in close proximity to each other.

[0088] The buccal light emitting elements can be configured to transmit light within a predetermined wavelength range, such as 200-740nm, 400-500nm, 425-475nm, or 445-465nm. In some embodiments, the buccal light emitting elements can be configured to transmit light across the entire electromagnetic spectrum, the entire visible light spectrum, the infrared spectrum, and / or the ultraviolet spectrum, or any combination of these. In some embodiments, some or all of the light emitting elements in any of the embodiments described herein can be configured to transmit continuous illumination, pulsed illumination, or a combination thereof. Although the energy transfer element may be referred to herein as an "illumination element," it should be understood that embodiments of the disclosed device can be configured to transmit electromagnetic energy from a wide range of frequencies along the electromagnetic spectrum, including but not limited to X-rays, gamma rays, microwaves, radio waves, or a combination thereof.

[0089] A temperature sensor may be provided on the subunit within the mouth as a safety precaution to ensure that the user is not uncomfortable. The temperature sensor may be configured, for example, to detect whether the light emitting system generates too much heat for the user. The controller may be configured to measure a value from the temperature sensor and interrupt operation of the light emitting system if the temperature sensor measures a temperature exceeding a predetermined threshold for a predetermined time interval. Suitable temperature thresholds include, but are not limited to, 40°C, 45°C, or 50°C. Suitable time intervals include, but are not limited to, 1 second, 5 seconds, 10 seconds, 30 seconds, one minute, or any time interval therebetween. Alternatively, the temperature sensor may be included in a circuit configured to interrupt power to the light emitting system independently of the controller, for example as an input to a relay or transistor.

[0090] One or more environmental sensors may be provided in the subject's mouth and configured to allow only the mouthpiece unit 702B to operate the light emitting system at full intensity when the mouthpiece unit is placed in conditions similar to the mouth environment. Suitable environmental sensors include ambient light sensors, proximity sensors, humidity sensors, pH sensors, resistance sensors, etc. In some embodiments, the ambient light sensor may be configured to measure light in a frequency band as different as possible from the frequency of light emitted by the buccal light emitting system. The ambient light sensor may be configured to allow only light within the desired frequency range to reach the light sensor by photodiode material selection (i.e., selecting a light sensor with a narrowband detector) or by using a broadband detector with an optical filter.

[0091] The sleeve 703 provides a replaceable physical interface between the electronics inside the mouthpiece unit 702B and the teeth and / or gums of the subject. The interface that contacts the teeth and soft parts of the mouth can include a flexible biocompatible sleeve. The purpose of the sleeve is to provide a comfortable cover for the mouthpiece unit that can be replaced as needed (e.g., if it becomes dirty, discolored, or damaged, etc.). The silicone should be transparent or translucent to the light emitted by the light emitting system.

[0092] The present invention also includes one or more treatment methods or methods of using the devices and systems described herein. Figure 8 The treatment method shown in includes the following steps and can be performed before or after the subject completes his or her usual oral health routine (eg, brush / brush / rinse). Figure 8 The method includes the steps of removing the device from the charging bay in step 801, confirming that the device is sufficiently charged by checking an indicator in step 802, applying an oral hygiene treatment agent to the top and bottom of the device in step 803, initiating light treatment and confirming that the device is functional in step 804, inserting the device into the subject's mouth in step 805, leaving the device in the subject's mouth for a predetermined period of time in step 806, waiting for an indication that treatment is complete in step 807, and removing the device from the subject's mouth in step 808.

[0093] In some embodiments, the method includes removing, cleaning, replacing and / or applying a disposable or reusable sleeve to a mouthpiece unit as described above. In some embodiments, the method of using the device of the present invention may include the steps of creating or obtaining a custom-sized sleeve manufactured to match the mouth of a specific subject, the sleeve being configured to be physically connected to the mouthpiece unit to ensure a proper fit. In some embodiments, the method of using the device of the present invention may include the steps of obtaining a sleeve that matches the subject from a set of standard-sized sleeves.

[0094] In another embodiment, the method of the present invention may include the following steps: waiting for a signal indicating that the device has been removed from the charger, providing an indication to the subject when the device is ready to begin treatment, receiving user input indicating the start of treatment, supplying power to one or more illumination elements at a first power level, waiting for one or more signals indicating, individually or in combination, that the device is in the user's mouth, supplying power to one or more illumination elements at a second power level, waiting for a predetermined period of time, turning off the one or more illumination elements, and providing an indication to the subject that treatment is complete.

[0095] In some embodiments, the treatment duration can be 10 seconds, 20 seconds, 30 seconds, 45 seconds, 60 seconds, 120 seconds, or any suitable duration depending on the subject. In some embodiments, the energy storage unit can have a limited capacity that can treat up to 5 minutes, 10 minutes, 20 minutes, or less on a single charge.

[0096] The various methods of the present invention may be implemented in whole or in part as software executed on a computing device. Fig. 9An exemplary software system diagram is shown in FIG. The software 901 shown includes a series of interconnected modules, including but not limited to a main state machine 902, a sleep manager 903, a temperature sensor driver 904, an infrared sensor driver 905, a user interface driver 906, a BLE driver 907, a light driver 908, and a charging interface 909.

[0097] The main state machine 902 is the main module that oversees the various functionalities of the device. It is responsible for operating the user interface, reading temperature and ambient infrared light levels, managing the BLE and RF charging interfaces, controlling the lighting system, and keeping power consumption low. Fig.10 A state diagram of an exemplary main state machine is shown.

[0098] The temperature sensor driver 904 communicates with the temperature sensor. The temperature sensor is used to ensure that the mouthpiece unit has a temperature that is compatible with the mouth before treatment begins. During treatment, if a threshold temperature is exceeded, an alarm is triggered using the temperature sensor. Once an alarm occurs, the light is turned off to avoid further heating.

[0099] The infrared sensor driver 905 works in conjunction with the light emission driver 908 to ensure that the infrared light intensity measured before starting treatment is compatible with the mouthpiece unit located in the mouth (i.e., very low). During treatment, the infrared sensor driver will periodically turn the light emission off, monitor the infrared light intensity, and turn the light emission back on so that the light emission system does not interfere with the infrared readings and the duty cycle of the light emission system is as high as possible.

[0100] The user interface driver 906 reads buttons or other inputs and lights up a signaling LED or other indicator depending on the different states of the main state machine 902. This module can also control a vibration motor to further notify the user. The BLE driver 907 provides GATT attributes for custom BLE services to match the reporting requirements of the corresponding smartphone application. The light driver 908 turns the LED in the mouthpiece unit on and off depending on the different states of the main state machine. The charging interface 909 monitors the charging interface and reports the charging status to the main state machine 902. Finally, the sleep manager 703 works in conjunction with the main state machine 902 to put the microcontroller to sleep as frequently as possible to save power in the energy storage unit while ensuring that the user interface remains responsive.

[0101] Some or all of the steps of the method of the present invention may be performed on a separate computing device (e.g., an application running on a smartphone or other portable computing device or a web portal interacting with a server or cloud instance) and communicatively connected to the mouthpiece unit via a wireless data connection. An exemplary smartphone application may allow monitoring functions, such as displaying battery status, a treatment timer, a sensor indicator, a ready treatment indicator, a treatment completion indicator, or a user compliance tracker or indicator. An exemplary smartphone application may also provide control signals to be sent from the application to the device, such as tapping a button in the application to start or stop treatment, or activating an auditory or visual positioning beacon on the device (e.g., a "find me" function). In addition, an exemplary smartphone application may provide reporting and compliance monitoring functions. For example, a smartphone application may collect sensor information or treatment information from a connected treatment device, and then transmit some or all of the collected information to a caregiver to verify that the treatment regimen provided by the caregiver is being followed. In some embodiments, the smartphone application may provide periodic reminders to the user, the user's guardian, and / or the user's caregiver (e.g., a parent) to perform treatment according to a predetermined schedule.

[0102] An exemplary smartphone application or web portal may further connect the device of the present invention to the internet, for example, via home WiFi or via Bluetooth, and may be used to create reminders for the user to apply treatment (e.g., via smartphone or email notifications or alerts). In some embodiments, the application or portal may be configured to create or display a report card of compliance data over a period of time to a user or guardian, caregiver, or parent of the user. The application or portal may provide the compliance data to an orthodontic practice. In response to the compliance data, a system or agent of an orthodontic practice may notify or send a reminder to the user or caregiver / guardian, for example, of the consequences of using the device or reminding the user of not using the device. In some embodiments, the application or portal may save data related to one or more users over a period of at least one or more orthodontic treatments. In some embodiments, the application or portal may prompt a caregiver or orthodontist to confirm whether a white spot lesion has formed during treatment. In some embodiments, the portal or all may provide inventory control or e-commerce functionality, such as allowing a user to order additional supplies or check inventory of a particular department.

[0103] The disclosure of each patent, patent application, and publication cited herein is hereby incorporated by reference in its entirety. Although the present invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of the present invention may be designed by those skilled in the art without departing from the true spirit and scope of the present invention. The appended claims are intended to be interpreted as including all such embodiments and equivalent variations.

Claims

1. An oral hygiene device comprising: a housing having an outer-mouth portion and an inner-mouth portion; at least one energy delivery element disposed in or on the intra-mouth portion and configured to deliver energy to one or more teeth of the subject; a controller disposed in the outer-mouth portion and electrically connected to the at least one energy transfer element; an energy storage unit disposed in the outer portion of the mouth; as well as a sleeve removably connected to the in-mouth portion of the housing, the sleeve having upper and lower channels configured to receive upper and lower teeth of a subject, Wherein, the sleeve includes at least one reflective element, which is located on the lingual side of the sleeve, and the reflective element is defined by a proximal surface and a distal surface, and either or both of the proximal surface and the distal surface can reflect all or part of the light in the visible spectrum, ultraviolet spectrum and / or infrared spectrum from the at least one energy transfer element.

2. The oral hygiene device of claim 1, further comprising at least one control element disposed on the outer-mouth portion.

3. The oral hygiene device of claim 1, further comprising a wireless communication interface electrically connected to the controller and configured for communication between the controller and a computing device external to the oral hygiene device.

4. The oral hygiene device of claim 1, further comprising at least one indicator element disposed in the outside-of-mouth portion.

5. The oral hygiene device according to claim 4, wherein: The indicator element is an LED.

6. The oral hygiene device of claim 1, wherein: The at least one energy transfer element is a plurality of LEDs.

7. The oral hygiene device of claim 6, wherein: These LEDs are configured to emit light in the range of 200 nm to 1500 nm.

8. The oral hygiene device of claim 7, wherein: These LEDs are configured to emit light in the range of 400 nm to 500 nm.

9. The oral hygiene device of claim 6, wherein: The LEDs are configured to deliver at least 30 mW / cm2 to the subject's teeth. 2 of light intensity.

10. The oral hygiene device of claim 1, further comprising a temperature sensor disposed in the in-mouth portion and communicatively connected to the controller, wherein The controller is configured to interrupt therapy if the temperature measured by the temperature sensor exceeds a threshold.

11. The oral hygiene device of claim 1 , further comprising at least one environmental sensor disposed in the intra-mouth portion and communicatively connected to the controller, wherein The controller is configured to initiate treatment if at least one measurement obtained from the at least one environmental sensor indicates that the oral hygiene device is located in the mouth of the subject.

12. The oral hygiene device of claim 11, wherein: The at least one environmental sensor comprises a light sensor.

13. The oral hygiene device of claim 1, wherein: The energy storage unit is a rechargeable battery.

14. The oral hygiene device of claim 13, further comprising a wireless charging system configured to charge the battery.

15. The oral hygiene device of claim 1, wherein: The at least one energy transfer element is located in an occlusal plane of the subject's teeth.

16. The oral hygiene device of claim 1, wherein: The at least one energy transfer element comprises: a first energy delivery element configured to deliver energy to a buccal surface of a tooth of a subject; and A second energy delivery element is configured to deliver energy to a lingual side of the subject's teeth.

17. The oral hygiene device of claim 1, wherein: The at least one energy delivery element is configured to deliver pulsed energy to one or more teeth of the subject.

18. The oral hygiene device of claim 1, wherein: The energy transfer element is configured to transfer electromagnetic energy having a spectrum selected from the group consisting of gamma rays, x-rays, ultraviolet light, visible light, infrared light, microwaves, and radio waves.

19. A method of using the oral hygiene device of any one of claims 1 to 18, comprising: applying a light activated therapeutic material to the oral hygiene device; awaiting an indication that the oral hygiene device is ready to begin treatment; activating a control element on the oral hygiene device to initiate oral hygiene treatment; inserting the oral hygiene device into the mouth of a subject; Wait for instructions on completion of treatment; as well as Remove the oral hygiene device from your mouth.

20. The method of claim 19, further comprising the step of applying the sleeve to the oral hygiene device.

21. The method of claim 20, further comprising the step of obtaining a sleeve custom made for the subject or obtaining a sleeve to fit the subject from a set of standard sized sleeves.

22. The method of claim 19, further comprising the step of charging an energy storage unit in the oral hygiene device.

23. A method of performing oral hygiene treatment using the oral hygiene device of any one of claims 1 to 18, comprising: waiting for a signal indicating that the oral hygiene device has been removed from the charger; providing an indication to the subject when the oral hygiene device is ready to begin treatment; receiving user input from the subject indicating initiation of treatment; supplying power to one or more energy transfer elements at a first power level; awaiting one or more signals that alone or in combination indicate that the oral hygiene device is in the subject's mouth; supplying power to the one or more energy transfer elements at a second power level; waiting a predetermined period of time and then shutting down the one or more energy transfer elements; as well as The subject was given an indication that the treatment was complete.

24. The method according to claim 23, wherein: The predetermined time period is two minutes or less.

25. The method of claim 23, further comprising: monitoring a temperature measured by a temperature sensor located on the oral hygiene device; as well as When the temperature exceeds a threshold, the one or more energy transfer elements are turned off.

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