阅读说明：本技术 用于口腔内治疗的口腔用具和方法 (Oral appliance and method for intra-oral treatment ) 是由 撒卡里·尼金玛 汤米·帕提拉 朱哈·兰塔拉 哈瑞·乔伊 于 2020-10-10 设计创作，主要内容包括：本发明涉及一种用于口腔内表面抗菌处理的口腔用具和方法。所述口腔用具包括由导热材料制成的主体,所述主体包括倾斜的面部和舌侧外表面以及分别适应于面部和舌侧表面的面部和舌侧内表面牙齿。光源连接到所述主体的倾斜表面并适于将光传送到牙齿表面,所述光源位于所述外表面中的至少一个并且适于经由所述内表面将所述光传送到所述面部和舌表面的牙齿。(The present invention relates to an oral appliance and method for the antimicrobial treatment of surfaces within the oral cavity. The oral appliance includes a body made of a thermally conductive material, the body including inclined facial and lingual outer surfaces and facial and lingual inner surface teeth that are adapted to the facial and lingual surfaces, respectively. A light source is connected to the inclined surface of the body and adapted to deliver light to a tooth surface, the light source being located on at least one of the outer surfaces and adapted to deliver the light to the teeth of the facial and lingual surfaces via the inner surface.)

1. An oral treatment device comprising an intraoral oral appliance (1), the intraoral oral appliance (1) comprising:

-a body (3-5, 9) made of a heat-conducting material, said body further having an upper surface (3) and an opposite lower surface (5), said surfaces respectively comprising a substantially planar portion between a lingual rim (7) and a buccal rim or lip (6) and being configured to be placed against a tooth surface, and

a plurality of light sources (10) connected to the body and adapted to deliver light to a tooth surface,

wherein:

-the edge comprises surfaces (6, 7), at least a part of which is planar and inclined so as to form, in a cross-section of the body, an angle of 5 to 85 °, in particular 10 to 55 °, with respect to the planar portion of the upper surface (3) and of the lower surface (5),

-at least a part of the light source (10) is located on at least one of the inclined buccal, labial or lingual margins of the body (3-5, 9), and

-the body and the light source are embedded in a housing (2) formed of a transparent polymeric material.

2. The device according to claim 1, wherein the body (3-5, 9) is made of a thermally conductive material having a thermal conductivity of more than 0.5W/mK, such as more than 1W/mK, in particular a thermal conductivity of 1.1 to 25W/mK for polymeric materials and a thermal conductivity of 100 to 500W/mK for metallic materials.

3. The device according to any of the preceding claims, wherein the body (3-5) and the light source (10) are at least partially enclosed by a housing (2) having the shape of a dental arch.

4. A device according to any one of the preceding claims, wherein the heat conducting body (3-5, 9) comprises an extension forming a cooling disc (9), which cooling disc (9) is capable of conducting heat from the body (3-5) inside the housing (2) to the outside of the housing.

5. A device according to any preceding claim, wherein the body (3-5) embedded in the housing (2) is capable of withstanding temperatures of up to 100 ℃ during operation of the device.

6. The device of any preceding claim, wherein the body comprises light reflecting elements, light guiding elements or both light reflecting and light guiding elements at the edges of the upper and lower surfaces of the body, the elements being capable of reflecting or guiding or both reflecting or guiding light from the light source.

7. The device according to any of the preceding claims, wherein the light source (10) comprises a multi-LED strip positioned and preferably arranged to follow the buccal, labial or lingual edge shape of the body (3-5, 9).

8. The device according to any one of the preceding claims, wherein the light source (10) is capable of operating at 30 to 1000mW/cm²In particular 50 to 500mW/cm²Emits light to the tooth.

9. The device according to any of the preceding claims, wherein the light source (10) is configured to emit light in at least one invisible wavelength band, such as in the band 780-820 nm.

10. Device according to any of the preceding claims, comprising an intra-oral sensor and means for adjusting the output power of the light source (10) on at least one wavelength, in particular at least one non-visible wavelength band, based on input from the intra-oral sensor.

11. The device according to any of the preceding claims, wherein the light source (10) is configured to emit invisible therapeutic light and visible safety light simultaneously, the visible safety light preferably having an intensity of more than 1.8cd, preferably 25cd, even more than 100 cd.

12. Kit comprising an oral treatment device according to any one of claims 1 to 11, comprising a body made of a thermally conductive material (15) and control electronics (14, 17) connected to the body, in particular through a male USB port of the body.

13. The kit of claim 12 comprising an oral formulation, particularly an active agent selected from benefit agents including antioxidants, photosensitizers and enhancers, and combinations thereof.

14. The kit according to claim 13, wherein the oral formulation is selected from the group consisting of antioxidants such as vitamin E or an analogue or precursor thereof, pigments and combinations thereof.

15. The kit of claim 13 or 14, wherein the oral formulation comprises a photosensitizer selected from hypericin, curcumin, a phenanone derivative, cercosporin, psoralen, flavotoxin, angelicin, alpha-trienyl, benzoporphyrin, THC, Cannabinol (CBD); synthetic photosensitizers include: RB (rose bengal), MB, porphyrin derivatives, curcumin derivatives, methylene blue, indocyanine green, paeonolone derivatives, fullerene derivatives, xanthine derivatives, optionally together with pigments; in particular, the oral formulation is selected from indocyanine green in combination with titanium dioxide, optionally further in combination with at least one antioxidant, such as E-vitamin or an analogue or precursor thereof.

Technical Field

The present invention relates to oral care. In particular, the present invention relates to a device for the antimicrobial treatment of surfaces within the oral cavity, such as teeth. The invention also relates to a method of delivering light in an oral photodynamic therapy oral appliance and a method of treatment of tissue in the oral cavity.

Background

Oral health can be improved by modulating bacteria in the oral cavity. However, there is currently no effective method to manage oral bacterial load or composition. More specifically, there is no effective method for preventing or treating Streptococcus mutans, also known as dental caries, bacterial infection. According to the introduction of professional dentists, oral bacterial cleaning is required every two months to maintain the normal operation of bacterial biofilms. Most people currently cannot do this because of the need for expertise and special equipment.

The use of light in photodynamic therapy (PDT) has an effect on oral bacteria. PDT requires a large amount of light energy, which creates heat build-up problems and the required intensity can also be harmful to the eye. Particularly in photosensitizer-enhanced oral PDT, such as indocyanine green (ICG) PDT, extremely high energy levels are required.

One known intra-oral treatment device is disclosed in US 7144249B2 and US 6616447B 1. The device comprises a LED strip consisting of LED lights covered by a transparent panel facing the dental surfaces of the face. A reflective panel may also be provided behind the LED lamp to maximize the light energy directed at the teeth. The device is suitable for whitening the surface of teeth. US 8371853B2 discloses another device suitable for the same purpose. Modifications to these instrument types and other existing intra-oral treatment devices and methods are disclosed, for example, in US 8241035B2, US7354448B2 and US 9572645B 2.

US 8215954B2 discloses an oral appliance consisting of light emitting diodes positioned inside and outside the arch of the teeth to treat the teeth on the facial and lingual surfaces. The device may also include periscope features that deliver light uniformly perpendicular from the LED to the tooth surface on each side.

Many existing solutions are based on transmitting only part of the light to the tooth surface and/or low light intensity, in which case the efficiency of the treatment is affected. Otherwise, a large number of LED elements are required to cover all of the tooth surfaces, which increases the manufacturing cost of the design and results in heat build-up. In general, low cost LEDs have low thermal efficiency and it is difficult to balance cost and heat build-up. Many of the proposed devices also have problems of unsuitability for mass production and poor safety. For example, in some designs, an LED element is placed on the occlusal surface of the tooth, and thus the LED may be damaged by the user accidentally biting on the LED. Meanwhile, the problem of the damage of near infrared rays to eyes is not properly solved.

For example, due to the above disadvantages, there are few viable consumer PDT products on the market. However, an efficient and safe PDT device may help the average consumer to perform frequent antimicrobial treatments.

Accordingly, there is a need for improved intraoral treatment devices.

Disclosure of Invention

It is an object of the present invention to address at least some of the above disadvantages and to provide a novel oral appliance for antibacterial treatment in the oral cavity.

It is a first object of the present invention to provide an oral treatment device comprising an oral appliance.

It is a second object of the present invention to provide a kit comprising an oral treatment device.

It is a third object of the present invention to provide a method of delivering light in an intraoral oral appliance for photodynamic treatment of teeth and tissues within the oral cavity.

It is a fourth object of the present invention to provide a method of treating tissue within a user's mouth.

The present invention is based on the idea of providing an oral appliance comprising a body made of a heat conductive material. The body generally has an upper surface and an opposing lower surface, the surfaces generally including a generally planar portion between two opposing edges, at least one tongue edge, and at least one cheek or lip. The configuration of the oral appliance is such that when the oral appliance is in use, the surface will abut the tooth surface and optionally the oral tissue. The upper and lower surfaces further comprise a plurality of light sources coupled to the body and adapted to deliver light to the tooth surface.

At least a portion of the opposite edges of the surfaces are planar and inclined so as to form a surface in cross section of the body at an angle of up to 90 ° to the planar portions of the upper and lower surfaces. At least a portion of the light source is preferably located on at least one of the inclined buccal, labial or lingual edges of the subject. The body and the light source are embedded in a housing formed of a transparent polymeric material. Such a material will protect the body while still allowing light to pass through the wrapper to reach the teeth and tissues while placing the oral appliance in a use position in the mouth of an individual.

In one embodiment, in the device, the inclined edges form an angle of 10 to 55 °, in particular 30 to 50 °, with respect to the plane portions of the upper and lower surfaces.

A kit comprises an oral appliance, preferably of the type described above, having a body made of a thermally conductive material, which is associated with control electronics connected to the body, in particular through a male USB port of said body.

The kit also includes an oral implement for oral use and an oral formulation, particularly an active agent selected from the group consisting of benefit agents including antioxidants, photosensitizers and enhancers and combinations thereof.

The oral appliance of the present invention can be used for light delivery for photodynamic therapy of teeth and tissues within the oral cavity. In use, at least a portion of the light source is located on at least one edge of the inclined buccal, labial or lingual side of the body and the light source is powered to deliver light to the teeth and intraoral tissue of the user.

Thus, the oral appliance is placed in the user's mouth such that the upper and lower surfaces engage at least at the chewing surfaces of the user's teeth; the light source is supplied with power for generating light; light is directed toward the user's teeth at an angle relative to the plane of the tooth chewing surface to effect photodynamic oral treatment of the teeth and the oral problem.

More specifically, the invention is characterized by what is stated in the characterizing part of the independent claims.

The present technique has considerable advantages. Embodiments of the present technology will help to improve process efficiency and mitigate heat buildup, which is a typical and related goal.

The invention also provides improved user safety and manufacturability.

The light source is preferably an LED (light emitting diode) that will provide high intensity light at a preselected wavelength with low thermal emission.

The oral appliance of the present invention is capable of distributing light evenly to the teeth and periodontal sites when the light source (e.g., an LED light source) is positioned on the teeth on the face or tongue surface. By placing the light source, in particular the LED, along the face or lingual side, i.e. in the area between the apex or cheeks of the tongue and the teeth, or between the teeth and the tongue, heat loss from the light source is absorbed by the surrounding tissue during light exposure.

Furthermore, placing the light source (e.g., light emitting diode) away from the occlusal surface of the tooth may reduce the risk of biting the LED component. The optical properties of the modular elements in the oral appliance provide for a uniform distribution of light over all surfaces of the teeth.

The thermal efficiency of the LED element may exceed 35%.

Further features and advantages of various embodiments are disclosed in the following non-limiting description of embodiments.

Drawings

FIG. 1 shows a perspective view of the housing mechanism of the oral appliance (uppermost) and three overlapping trays within the housing according to one embodiment;

FIG. 2 shows a kit according to one embodiment comprising an oral appliance, a control unit, a local light head, and a charging stand;

FIG. 3 illustrates a perspective view of a portion of an embodiment of a tray including a row of light emitting assemblies positioned diagonally along an edge of the tray and a number of light emitting assemblies positioned in an inset manner on a mating surface of the tray;

fig. 4 shows a stand-alone implementation of an oral appliance according to one embodiment.

Detailed Description

The present technology relates generally to oral appliances and methods for antimicrobial treatment of interior surfaces of the oral cavity.

In various embodiments, the oral appliance includes a body made of a thermally conductive material that includes inclined facial and lingual outer surfaces and facial and lingual inner surfaces that are adapted to the facial-facial and lingual surfaces teeth, respectively. A light source is coupled to the angled surface of the body and adapted to deliver light to the tooth surface, the light source being located on at least one of the outer surfaces and adapted to deliver the light to the tooth on the face and tongue surfaces through the inner surface.

In one embodiment, an oral treatment device includes an oral appliance comprising a body made of a thermally conductive material having an upper surface and an opposing lower surface. The surfaces are configured, preferably on two opposite sides of the generally planar body, on a plurality of surfaces including a plane or substantially planar portion between the side edges, at least on the outer side, preferably on the opposite sides.

Thus, in one embodiment, there is a tongue edge and a cheek edge and/or a lip. The planar portion or preferably the planar portions are configured to abut against the surfaces of the user's teeth when the oral appliance is placed between the teeth in the user's mouth. Thus, the plane of the body will abut the occlusal surface of the tooth.

The body also includes at least one, but preferably a plurality of light sources coupled to the body and adapted to deliver light to the tooth surface. Generally, each side has 1-20 light sources on the lingual side and 1-10 light sources on the labial side. By providing a plurality of light sources to the body, it can be ensured that light is emitted uniformly to the teeth and gum area or other intra-oral area.

Furthermore, the edges arranged on either or both sides of the planar portion comprise or essentially consist of a bevel. At least a portion or all of the edge surface is planar. The surface is further at least partially inclined to form an angle of up to 90 deg., in particular about 5 to 85 deg., with respect to at least one planar portion of the upper and lower surfaces. By placing at least a portion of the light source on at least one of the inclined buccal, labial or lingual edges of the body, light can be emitted at an angle of up to 90 °, in particular 5 to 85 °, on the surface of the tooth and on the tissues within the oral cavity, such as the gums surrounding the tooth.

It should be noted that the angle of the edge of the body may vary in different parts of the oral appliance, for example 5 to 30 in a first part of the body and 25 to 60 in a second part of the body.

The oral appliance preferably comprises a housing for the body and the light source. In particular, the body and the light source are embedded in an enclosure formed of a transparent polymeric material.

In one embodiment, the body fitted with the light source is shaped such that the LEDs are provided at an angle of 90 ° or less (but preferably 5 ° or more) on the base surface of the body to direct light to the teeth. Treatment and adjustment of the light intensity can be accomplished by adjusting the angle of the body base to direct the LEDs toward the teeth or toward the gums or other tissues in the mouth.

In one embodiment, the present technology also provides a method of delivering light in an intraoral oral appliance for photodynamic treatment of teeth and tissues within the oral cavity.

The method includes the step of providing a body made of a thermally conductive material, the body further having an upper surface and an opposite lower surface, the surfaces each including a generally planar portion between the lingual rim and the buccal rim or lip and being configured to be placed against a tooth surface.

At least a portion of the surfaces are planar and inclined so as to form an angle of 5 to 85 DEG in cross section of the body relative to the planar portions of the upper and lower surfaces.

In the method, a body light source is located on at least a portion of the edge of the body, the light source adapted to deliver light to the tooth surface and tissue within the oral cavity and to provide power to the light source.

In a method of treating a user's teeth and tissues within the mouth, an oral appliance as discussed above is placed in the user's mouth such that the upper and lower surfaces engage at least the chewing surfaces of the user's teeth; providing power to a light source for generating light; the light and the chewing surface plane of the tooth form a certain angle, especially an oblique angle, and the light irradiates on the tooth of a user, so that the photodynamic oral treatment on the tooth and the tissues in the oral cavity is realized.

Further details of embodiments will be shown in the drawings.

Typical features of one embodiment are shown in fig. 1:

a polymeric cover or housing 2, which may comprise silicone rubber or thermoplastic, preferably transparent or translucent, and which has proven suitable for human use;

sheets or layers 3, 5, preferably flexible, and each layer comprising in particular a printed circuit board;

a light emitting element (light source) 10 including, for example, a Light Emitting Diode (LED); and

a body in the form of a sheet or plate 4, generally U-shaped (in the planar direction) and preferably rigid.

In the context of this application, the term "rigid" means that the body (i.e., sheet or plate) 4 does not deform during normal use of the oral appliance-e.g., it does not substantially bend in the longitudinal or transverse directions due to occlusal forces applied by a user of the oral appliance.

The sheet or plate 4 comprises in particular a heat-conducting material.

Preferably, the body comprises a substantially U-shaped arc (3-5) to enable following of the dental arch.

The structure 4 will also be referred to hereinafter as a "tray" or "heat dissipating (or" heat conducting ") tray".

Similarly, fig. 3 shows a portion of a tray according to an embodiment, the reference numeral 21 generally referring to the tray and the reference numeral 24 referring to the planar portion of the tray 21. Reference numerals 22 and 23 denote inclined edge portions of the tray, and reference numerals 25 and 26 denote light sources. As will appear, the first group (reference numeral 25) is located at the inclined edge portion of the tray 21. The second set 26 is located on the planar portion 24 of the tray 21.

The tray typically comprises a metal body or a thermally conductive polymeric body or a combination thereof. The preferred thermal conductivity (also referred to as "thermal conductivity") of the host material (hereinafter referred to as "matrix") is greater than 0.5W/mK. For metal substrates, this is generally between 1 and 1000W/mK, preferably between 5 and 400W/mK, in particular between 50 and 250W/mK. The polymer base preferably has a thermal conductivity of between 0.5 and 100W/mK, preferably 1 to 20W/mK, for example 5 to 15W/mK. The above values represent "in-plane thermal conductivity", which can be determined by ASTM E1461.

In one embodiment, the thermally conductive material of the body has a thermal conductivity of more than 0.5W/mK, for example more than 1W/mK, in particular a thermal conductivity of 1.1 to 25W/mK for a polymeric material and a thermal conductivity of 100 to 500W/mK for a metallic material.

As shown in fig. 1 and 3, at least a portion of the light source 10; 22 are configured to be opposite to the tray 4; 21 plane 11; 24 transmit light at an angle, particularly an oblique angle.

A tray 4; 21 allow the collection of light sources to enter the oral appliance so that the collection of light sources can direct light at an angle. For this purpose, the tray 4; 21 are included at the opposite edge portions 8; 22. 23, planar area portions 11 defined therebetween; the edge portions 22, 23 are inclined with respect to said plane portion or comprise plane portions 24. Thus, as shown in fig. 1 and 3, the tray at least partially exhibits a cross-section in the shape of a glass. It will also appear that the edges are inclined so as to form a slope towards the planar portions of the upper and lower surfaces.

In one embodiment, the body comprises light reflecting or light guiding elements or both at the edges of the upper and lower surface of the body, which elements are capable of reflecting or guiding or both reflecting or guiding light emitted from the light source.

In one embodiment, a light emitting component may be embedded in the rigid tray to increase light entering the occlusal surface and to protect the component from mechanical stress. One possible option is to use a double-sided flexible circuit board and provide asymmetrical holes in the tray to allow light to pass to the other side of the oral appliance.

The treatment and light intensity can be adjusted by adjusting the position of the light emitting face of the light source relative to the tooth. Thus, the light source may be configured to emit light to the teeth or gums, or both. The supporting edges 6, 7 of the tray can also be adjusted; 22. 23 and/or the thickness of the polymer cover to adjust the light distribution.

In one embodiment, the light source provides light that illuminates the tooth or gum or both at an acute or oblique angle. In one embodiment, the angle of the light emitting surface of the light source varies between 0 and 90 °, preferably the light illuminates the teeth or gums or both at an angle of about 5 to 85 ° (e.g. between 30 and 60 °) and in particular at an angle of 35 to 50 °. The angle refers to the direction of the incident light wave, which has the maximum energy of the light emitted by the light source.

In one embodiment, when using an LED or similar light source having at least substantially the same light emitting surface, it is preferred that the surface is configured to emit light at an oblique angle, preferably about 5 to about 85 °, relative to a plane defined by the occlusal surface of the tooth. To this end, the light source may be mounted at an oblique angle on an edge portion of the tray, the edge portion being located on either or both sides of the plane of the tray. In particular, the plane is preferably configured to abut an occlusal surface of the tooth when the oral appliance is in use.

As shown in FIG. 3, the tray may also have a light source, such as an LED 23, embedded in the occlusal surface to increase the intensity of light directed at the occlusal surface of the teeth.

The light source may be configured as a flexible printed circuit board. A general tray 4; 21 support two LED strings on each side of the tray as shown in fig. 1.

The light source may comprise a plurality of LED strips located and preferably arranged to follow the shape of a buccal, labial or lingual edge of the body.

The light source may be located on either the buccal side or the labial side of the body, or both. They may also be positioned on the outer surface of the tongue of the body.

In one embodiment, the light source is adapted to deliver light to the tongue through an outer tongue surface of the body.

In one embodiment, the light source (e.g., LED) used in the oral appliance is capable of emitting an average power density of 30 to 1000mW/cm to the teeth²In particular 50 to 500mW/cm²Of (2) is detected.

The LEDs may be connected to any type of circuit board including, but not limited to, flexible PCBs, copper strips, metal PCBs, semi-flexible PCBs, and combinations thereof.

The thermal connection between the tray and the light emitting elements may be increased by a thermally conductive material (not shown), such as thermal adhesive or thermally conductive glue.

A tray 4; 21 dissipate heat through hot spots around the mouth where it is dissipated in a controlled manner to the oral surfaces of the user. Provides good optical power and solves the problem that the light-emitting element is overheated or forms local hot spots.

As shown in the embodiment of fig. 1, the outlet portion 9 of the tray 4 may protrude from the silicone cover and may contain passive or active cooling functionality 2'. The tray 4 also has grooves or ducts to allow coolant or air to flow within the tray. Active cooling includes, but is not limited to, auxiliary air cooling, water cooling, oil cooling, or peltier cooling, or a combination thereof. Passive cooling includes, but is not limited to, air cooling by convection, heat pipe cooling, evaporative or regenerative cooling, radiant cooling, or combinations thereof.

In one embodiment, the tray is connected to an active cooling unit for cooling the housing inner body, said active cooling being connected to a temperature sensor to allow the cooling of the body to be adjusted according to the temperature of the oral appliance.

The oral appliance cover 2 comprises or consists of a polymeric material approved for oral administration, such as silicone rubber or a thermoplastic material or a combination thereof. The cover comprises a single uniform layer or multiple layers of the same or different materials. The cover also includes an optically active ingredient or material that alters the optical properties of the oral appliance or induces other effects such as, but not limited to, an antibacterial effect by generating Reactive Oxygen Species (ROS). The optically active compound belongs to but is not limited to TiO₂、SiO₂Doped with derivatives thereof, for example doped with Au, Ag, N, Fe or Cu derivatives or combinations thereof.

In one embodiment, the polymeric material forming the housing comprises an antimicrobial and/or light diffractive material (e.g., TiO)₂、SiO₂Ag, metal doped TiO₂Metal doped SiO₂、N-TiO₂、N-SiO₂Or silver nanoparticles or combinations thereof), antibacterial andor a mixture of light diffractive materials or as a coating for the housing.

In embodiments of the invention where the occlusal surface is not embedded in the light emitting surface, the outlet thickness in the occlusal region of the teeth exceeds 1mm, preferably 2-3mm, and most preferably up to 10 mm. A thickness of 5 to 10mm is of particular interest for soft materials.

In an embodiment of the invention the thickness of the LED cover on the occlusal surface 23 exceeds 0.1mm, preferably exceeds 1mm and up to 10 mm.

Generally, the body embedded in the housing is capable of withstanding temperatures of up to 100 ℃ during operation of the device.

For optimal therapeutic effect, the oral appliance of the present invention should be used as a kit, including interchangeable oral appliances and local illumination heads, control units and charging stations, with active substances.

For optimal therapeutic effect, the oral appliance of the present invention should be used as a kit, including interchangeable appliances and local illumination heads, control units and charging stations, with active substances.

Various embodiments relate to an oral appliance comprising a body made of a thermally conductive material, the body comprising inclined facial and lingual outer surfaces and facial and lingual inner surface teeth adapted to the facial and lingual surfaces, respectively. A light source is coupled to the angled surface of the body and adapted to deliver light to the tooth surface, the light source being located on at least one of the outer surfaces and adapted to deliver light through the inner surface to the tooth on the face and tongue surfaces.

In one embodiment, the light source is configured to emit invisible therapeutic light and visible safety light simultaneously, preferably with an intensity of more than 1.8cd, preferably more than 25cd and even more than 100 cd. The intensity is preferably equal to or less than 5000cd, especially equal to or less than 3000cd, for example 1500cd or less.

In one embodiment, the light source is configured to emit light to achieve a treatment intensity and treatment time based on sensory input, in particular based on an intra-oral sensor.

Preferably, at least a portion of the light sources are capable of producing light having a plurality of peak wavelengths.

In one embodiment, at least some of the light sources have a plurality of light emitting surfaces.

In one embodiment, the housing includes bristles, shapes, rods capable of brushing teeth and a motor capable of moving or vibrating the bristles, shapes and rods, and combinations thereof.

Turning to fig. 3, it is noted that the light source 10 may be connected to a power source 12, such as a built-in electrical energy store, for powering the light source.

As shown in this figure, a kit comprising an oral treatment device comprises a body made of a thermally conductive material 15 and control electronics 14, 17 connected to the body, in particular, the control electronics being connected to the body through a male USB port of the body.

In one embodiment, the kit includes an oral treatment device as well as control units 14, 17, LED head 13 and docking station 11.

In one embodiment, the outlet of the oral treatment device is connectable to a USB-C port.

In one embodiment, the kit comprises an oral formulation, particularly an active agent selected from benefit agents including antioxidants, photosensitizers and enhancers, and combinations thereof. Thus, for example, the oral formulation may be selected from anti-oxidant molecules such as vitamin E or analogs or precursors thereof, pigments, and combinations thereof.

Specific examples of active agents, especially oral formulations, include photosensitizers selected from the group consisting of hypericin, curcumin, phenanone derivatives, cercosporin, psoralen, flavotoxins, angelicin, alpha-trienyl, phenyl phenylalanine, THC, Cannabinol (CBD). Synthetic photosensitizers include: RB (rose bengal), MB, porphyrin derivatives, curcumin derivatives, methylene blue, indocyanine green, paeonolone derivatives, fullerene derivatives, xanthine derivatives, optionally together with pigments.

In one embodiment, the oral formulation is selected from indocyanine green and titanium dioxide, optionally in further combination with at least one antioxidant (e.g., an E-vitamin or an analog or precursor thereof).

In one embodiment, the oral appliance includes a means for mechanically vibrating the body while positioned within the oral cavity.

The oral appliance may include a built-in electrical energy store, such as a battery or super capacitor, for powering the light source and any other electronic functions contained by the oral appliance. In some embodiments, the energy storage may be charged wirelessly.

For example, the power may be turned on automatically when disconnected from the charger, or manually when a user's bite on the oral appliance is detected by a suitable sensor.

In one embodiment, the power storage is achieved using one or more super capacitors, which are capable of driving the device for at least 1 minute, preferably at least 2 minutes, for example from 5 minutes up to 120 minutes, in particular at least 15 minutes up to 30 minutes. For example, there may be one supercapacitor for each LED or group of LEDs.

The device may also have one or more sensors. This allows for measurement and/or feedback functions for the treatment process. In some embodiments, at least one sensor is provided to measure light absorption of the LED assembly from the LED current. In an alternative or supplementary embodiment, at least one light sensitive element, e.g. a diode, may be provided, capable of measuring light absorption. Light absorption information can be correlated to the amount of biofilm on the top of the tooth and the early onset of caries.

In some embodiments, the oral appliance has a sensor for measuring changes in absorbed light of an emission wavelength, or wherein a component associated with the sensor output emits light of a first wavelength and the sensor input detects light of a second wavelength different from the first wavelength.

In some embodiments, the oral appliance has one or more temperature sensors adapted to measure the temperature of the light source or its surroundings. There may also be means to continuously monitor the temperature and limit the LED power if the temperature rises to a predetermined level. This will ensure the safety of the user and allow the LEDs to be kept in the optimum area for optimum thermal efficiency.

In some embodiments, the oral appliance surface is at least partially coated with a thin layer of titanium dioxide that will generate reactive oxygen species when 405nm light is emitted from the structure. The titanium dioxide can be used as a diffusion or diffraction material of an outlet and has a bactericidal treatment effect.

In some embodiments, lightweight photodynamic processing devices for inefficient local use can also be manufactured by using only one or two modular elements with a limited number of electronic components. And charging the super capacitor in a wireless mode. When removed from the charger, the device lights up.

In some embodiments, the appliance has a self-antimicrobial function by providing an antimicrobial layer thereon and periodically illuminating the antimicrobial layer, for example, in a standby mode (e.g., in a charger). For example, the oral appliance may provide 405nm light to titanium dioxide particles contained in the oral appliance.

In one exemplary application, treatment is initiated by applying the active ingredient product to the oral cavity, then placing the oral appliance in the oral cavity, and connecting the oral appliance to the external control unit by cable or wirelessly. The control unit may be a mobile device that is easily carried during the treatment. After the treatment is completed, the probiotic product may be taken, for example, in the form of a chewing gum, a tablet, a paste or a liquid.

In one embodiment, the oral appliance includes at least one sensor, such as an optical sensor, for measuring the response of the tissue within the oral cavity or formulation within the oral cavity to the light emitted therefrom, such as the photo-bleaching of the active ingredient or the amount of active ingredient in the treatment area.

In some embodiments, the photodynamic therapy oral appliance of the invention has one or more safety features that prevent a user from injuring himself/herself with high intensity invisible light. In one embodiment, the safety function is based on adjusting the brightness of light sources outside the 390-700 nm wavelength, adjusting the sensor input based on the device, or including additional luminescent light sources in the visible 390-700 nm spectrum to create a natural and active aversive response of the eye to bright light. Additionally, the device may be configured to transition from the low power state to the high power state upon detection of a target wavelength from a treatment region inherent to the target molecule. In some embodiments, the device utilizes 780-815nm light as the primary active light, with bright white light as the eye-protecting light.

In some embodiments, the device is configured to switch from low power to high power therapeutic radiation only after detecting fluorescent radiation from its target region by using the sensor, thereby achieving protection of the eye and other tissues from unnecessary radiation exposure.

In one embodiment, the light source is configured to emit light in at least one invisible wavelength band, for example in the band 780-820 nm.

In one embodiment, the oral appliance includes an intraoral sensor and means for adjusting the output power of the light source at least one wavelength (particularly at least one non-visible wavelength band) based on input from the intraoral sensor.

Further, in some embodiments, the means for adjusting the power output of the light source is configured to increase the power output of the light source in response to detecting a particular wavelength by the intraoral sensor.

As defined in the following embodiments:

detailed description of the preferred embodiments

1. An oral treatment device comprising an intraoral oral appliance (1) comprising:

-a body (3-5, 9) made of a heat-conducting material, said body further having an upper surface (3) and an opposite lower surface (5), said surfaces respectively comprising a substantially planar portion between a lingual rim (7) and a buccal rim or lip (6) and being configured to be placed against a tooth surface, and

a plurality of light sources (10) connected to the body and adapted to deliver light to the tooth surface,

wherein:

-said edge comprises surfaces (6, 7) at least a part of which is planar and inclined so as to form, in a cross section of the body, an angle of 5 to 85 DEG with respect to the planar portions of the upper surface (3) and of the lower surface (5),

-at least a part of the light source (10) is located on at least one of the inclined cheeks, lips or tongue edges of the body (3-5, 9), and

-the body and the light source are embedded in a housing (2) formed of a transparent polymeric material.

2. The device according to embodiment 1, wherein the inclined edges (6, 7) form an angle of 10 to 55 °, in particular 30 to 50 °, with respect to the plane portions of the upper surface (3) and the lower surface (5).

3. The device according to embodiment 1 or 2, wherein the edges (6, 7) are inclined to form a slope toward the upper and lower surface plane portions.

4. The device according to any of embodiments 1 to 3, wherein the polymeric material forming the housing (2) comprises, mixed with or as a coating of the housing, an antibacterial and/or light diffractive material, such as TiO₂、SiO₂Ag, metal doped TiO₂Metal doped SiO₂、N-TiO₂、N-SiO₂Or silver nanoparticles or combinations thereof.

5. A device according to any of the embodiments above, wherein the polymeric material comprises a transparent or translucent thermoplastic or thermoset material, such as a silicon, polycarbonate or polyacrylate polymer.

6. The device according to any of the above embodiments, wherein the body (3-5, 9) is made of a thermally conductive material having a thermal conductivity of more than 0.5W/mK, such as more than 1W/mK, especially a thermal conductivity of 1.1 to 25W/mK for polymeric materials and a thermal conductivity of 100 to 500W/mK for metallic materials.

7. The device according to any of the above embodiments, wherein the body (3-5) and the light source (10) are at least partially enclosed by a housing (2) having the shape of an arch of teeth.

8. A device according to any of the above embodiments, wherein the body (10) is encased by a casing (2), the thickness of the body in the bite area extending to 0.1mm or more, in particular 1mm to 10mm, for example 2 to 5 mm.

9. A device according to any of the above embodiments, wherein the heat conducting body (3-5, 9) comprises an extension forming a cooling disc (9), the cooling disc (9) being capable of conducting heat from the body (3-5) inside the housing (2) to the outside of the housing.

10. A device according to any of the above embodiments, wherein the body (3-5) embedded in the housing (2) is capable of withstanding temperatures up to 100 ℃ during operation of the device.

11. The apparatus according to embodiment 9 or 10, wherein the tray (9) is connected to a passive cooling unit for cooling a portion of the main body (3-5) mounted in the housing (2).

12. The device according to any of embodiments 9 to 11, wherein said tray (9) is connected to an active cooling unit for cooling the component bodies (3-5) mounted in the housing (2).

13. The apparatus according to any of embodiments 9 to 12, wherein the tray is connected to an active cooling unit for cooling a body within a housing, the active cooling being connected to a temperature sensor to allow the cooling of the body to be adjusted according to the temperature of the oral appliance.

14. The device according to any of the embodiments above, wherein said body comprises a substantially U-shaped arc (3-5) to enable following of the dental arch.

15. The apparatus of any of the above embodiments, wherein the body comprises light reflecting elements, light directing elements, or both light reflecting and light directing elements located at the edges of the upper and lower surfaces of the body, the elements capable of reflecting or directing or both reflecting or directing light from the light source.

16. The device according to any of the above embodiments, wherein the light source (10) comprises a multi-LED strip located and preferably arranged to follow the buccal, labial or lingual rim shape of the body (3-5, 9).

17. The apparatus according to any of the above embodiments, wherein the light source (10) is located on either the buccal side or the labial side of the body, or both.

18. The device according to any of the above embodiments, wherein the light source (10) is located on the lingual outer surface of the body.

19. The apparatus according to any of the above embodiments, wherein a light source (10) is also placed on at least a portion of the planar portion of the upper and lower surfaces, the light source capable of being directed toward the teeth of the chewing surface when the oral appliance is in use.

20. The device according to any of the above embodiments, wherein the body (3-5) has a cross-sectional profile in the shape of a time glass, which is capable of covering the horizontal and two vertical surfaces of the tooth at one or two tooth lines, respectively.

21. The device according to any of the above embodiments, wherein the light source (10) is capable of operating at 30 to 1000mW/cm²In particular 50 to 500mW/cm²Emits light to the tooth.

22. The device according to any of the embodiments above, wherein the light source (10) is adapted to deliver light to the tongue through the lingual outer surface of the body (3-5).

23. A device according to any of the embodiments above, comprising at least one sensor, such as an optical sensor, for measuring the response of the tissue within the oral cavity or the formulation within the oral cavity to the light emitted therefrom, such as the photo-bleaching of the active ingredient or the amount of active ingredient in the treatment area.

24. The device according to any of the embodiments above, comprising means for mechanically vibrating the body while positioned within the oral cavity.

25. The device according to any of the above embodiments, wherein the light source (10) is configured to emit light in at least one non-visible wavelength band, for example in the band of 780-820 nm.

26. An apparatus according to any of the above embodiments, comprising an intraoral sensor and means for adjusting the output power of the light source (10) at least one wavelength, in particular at least one non-visible wavelength band, based on input from the intraoral sensor.

27. The apparatus of embodiment 24 wherein the means for adjusting the power of the light source output is configured to increase the power output of the light source (10) in response to detection of a particular wavelength by the intraoral sensor.

28. The device according to any of the above embodiments, wherein the light source (10) is configured to emit invisible therapeutic light and visible safety light simultaneously, the visible safety light preferably having an intensity of more than 1.8cd, preferably 25cd, even more than 100 cd.

29. The apparatus according to any of the embodiments above, wherein the light source (10) is configured to emit light based on sensory input, in particular based on an intra-oral sensor, to obtain the treatment intensity and treatment time.

30. The apparatus according to any of the above embodiments, wherein at least a portion of the light sources (10) are capable of generating light having a plurality of peak wavelengths.

31. The device according to any of the above embodiments, wherein at least a portion of the light sources (10) have a plurality of light emitting surfaces.

32. The device according to any of the above embodiments, wherein the light source (10) is connectable to a power source (12), such as a built-in electrical energy reservoir, for powering the light source.

33. The device according to embodiment 32, wherein the electrical energy store is realized using one or more supercapacitors which are capable of operating the device for at least 1 minute, preferably at least 2 minutes, such as from 5 minutes up to 120 minutes, in particular at least 15 minutes and up to 30 minutes.

34. The device according to any of the above embodiments, wherein the housing (2) comprises bristles, formations, rods capable of brushing teeth and a motor capable of moving or vibrating the bristles, formations or rods or a combination thereof.

35. A kit comprising an oral treatment device according to any one of embodiments 1 to 34, comprising a body made of a thermally conductive material (15) and control electronics (14, 17) connected to the body, in particular through a male USB port of the body.

36. The kit according to embodiment 35, comprising the oral treatment device according to any one of embodiments 1 to 19, and a control unit (14, 17), an LED head (13), a docking station (11).

37. The kit of embodiment 35 or 36, wherein the oral appliance of the oral treatment device is connectable to a USB-C port.

38. A kit according to any of embodiments 35 to 37, comprising an oral formulation, in particular an active agent selected from benefit agents including antioxidants, photosensitizers and enhancers and combinations thereof.

39. The kit according to embodiment 38, wherein the oral formulation is selected from the group consisting of antioxidant molecules such as vitamin E or an analog or precursor thereof, pigments, and combinations thereof.

40. The kit of embodiment 38 or 39, wherein said oral formulation comprises a photosensitizer selected from the group consisting of hypericin, curcumin, a phenazone derivative, cercosporin, psoralen, flavotoxin, angelicin, alpha-trienyl, benzoporphyrin, THC, Cannabinol (CBD). Synthetic photosensitizers include: RB (rose bengal), MB, porphyrin derivatives, curcumin derivatives, methylene blue, indocyanine green, paeonolone derivatives, fullerene derivatives, xanthine derivatives, optionally together with pigments.

41. The kit according to embodiment 40, wherein the oral formulation is selected from indocyanine green and titanium dioxide, optionally in further combination with at least one antioxidant (e.g. an E-vitamin or an analogue or precursor thereof).

42. A method of delivering light in an intraoral oral appliance for photodynamic treatment of teeth and tissue within the oral cavity, comprising:

-providing a body made of a heat conductive material, said body further having an upper surface and an opposite lower surface, said surfaces comprising a substantially planar portion between a lingual rim and a buccal rim or lip, respectively, and being configured to be placed against a tooth surface,

-connecting a plurality of light sources to the body, and

-adjusting the light source to transmit light to the tooth surface and the tissue in the mouth,

further comprising:

-on the edges, at least a part of said edges being planar and inclined so as to form, in a cross-section of the body, an angle of 5 to 85 DEG with respect to the planar portions of the upper and lower surfaces,

-placing at least a part of the light source on at least one of the inclined buccal, labial or lingual edges of the subject, and

-providing power to the light source to deliver light to the teeth and intraoral tissue of the user.

43. A method of treating tissue within a user's mouth, comprising:

-providing an oral appliance according to any of embodiments 1 to 34;

-placing the mask in the mouth of the user with the upper and lower surfaces engaging at least the chewing surfaces of the teeth of the user;

-providing the light source with power for generating light; and

-directing light at a certain angle to the plane of the tooth chewing surface towards the teeth of the user to achieve photodynamic oral treatment of dental and oral problems.