Intraoral phototherapy device

Abstract

An intraoral phototherapy device is provided that improves irradiation of the tonsillar region of the oral cavity. Oral tissue irradiation is particularly difficult in the back of the throat. The intraoral phototherapy device improves irradiation of these tissues by using a breathing tube to improve breathing of the patient. The breathing tube allows the patient to breathe through the mouth, thereby opening up the tonsillar region of the oral cavity. Additionally, objects that come into contact near the back of the throat often induce a gag reflex. This gag reflex reduces the available time to administer phototherapy and makes it difficult to deliver phototherapy to the back of the throat. The intraoral phototherapy device can weaken the gag reflex by contacting the hard palate of the oral cavity with a dorsal fin so that the intraoral phototherapy device does not contact the further back of the oral cavity.

Description

Related Applications

[0001] This application claims the benefit of Application No. 63 / 242,166, filed September 9, 2021, which is incorporated herein by reference in its entirety. [Technical Field]

[0002] The present invention relates generally to phototherapy, and more particularly to an intraoral phototherapy device. [Background technology]

[0003] Phototherapy can be used to treat a variety of conditions, including a condition called oral mucositis, and for pain relief. Phototherapy is delivered directly to tissue by several methods, for example, via low-level laser therapy or light-emitting diode (LED) arrays that deliver light through the skin into the diseased area.

[0004] Currently, there are two known methods of applying phototherapy for the treatment of various phototherapy conditions of the oral cavity, including, for example, oral mucositis: low-level laser therapy and light-emitting diode (LED) arrays. Oral mucositis is one of the most common and significant toxicities of cancer therapy.

[0005] Barriers to the acceptance of low-level laser therapy include the cost and labor intensity of laser equipment. Additionally, there are issues with variability between operators and the need for specialized training. Also, patients undergoing this form of treatment are required to keep their mouths open for extended periods of time, which is uncomfortable and becomes very painful as the mucositis progresses.

[0006] LED arrays use multiple LEDs to externally illuminate a large area of ​​tissue. Light rays from these arrays penetrate the skin and stimulate the mucous membranes. LED arrays have the advantage of illuminating a large surface area, are simpler to implement than spot laser systems, and are more comfortable for the patient. The main disadvantages of utilizing LED arrays to apply phototherapy treatments are the lack of dosage control as the LED array must transilluminate the cheek tissue and the difficulty of reaching all areas of the oral cavity, including the tonsillar and palatal areas that are prone to oral mucositis. Also, variations in tissue thickness between different cheek regions and between different patients make it difficult to precisely monitor and control the dose of light delivered to the mucosa. Summary of the Invention [Problem to be solved by the invention]

[0007] Many patients experience painful lesions caused by oral mucositis in the back of the mouth in the throat and tonsillar areas. However, it is difficult to treat these affected areas because it is difficult to reach them with phototherapeutic light. [Means for solving the problem]

[0008] The present invention provides an intraoral phototherapy device that uses a breathing tube to irradiate the tonsillar region of the oral cavity, thereby improving the patient's breathing and thereby opening up the tonsillar region for improved irradiation of tissue located at the back of the throat.

[0009] The present invention also provides an intraoral phototherapy device that uses dorsal projections to illuminate the tonsillar region of the oral cavity, interacting with the palate of the oral cavity to reduce nausea and open the tonsillar region for improved illumination of tissue located at the back of the throat.

[0010] The present invention also provides a three-pronged, branched sleeve that houses the intraoral phototherapy device to provide a barrier between the intraoral phototherapy device and the oral cavity, maintaining the sleeve in proximity to the intraoral phototherapy device to improve breathing for the patient and thereby opening up the tonsillar area for improved irradiation of tissue located in the back of the throat.

[0011] The present invention describes several features, and features described with respect to a given embodiment may also be employed with respect to other embodiments. The following description and accompanying drawings set forth embodiments of the invention. On the contrary, these embodiments are indicative of but a few of the many ways in which the principles of the invention may be employed. Other objects, advantages and novel features of aspects of the present invention will become apparent from the following detailed description when considered in conjunction with the drawings. [Brief explanation of the drawings]

[0012] The accompanying drawings, which are not necessarily to scale, illustrate various aspects of the present invention, and like reference numerals are used in the various drawings to indicate the same or similar parts. The present invention will now be described in detail with reference to the drawings. In the drawings, each element having a reference number is similar to other elements having the same reference number regardless of any letter designation following the reference number. In the specification, a reference number having a particular letter designation following it refers to the particular element having that number and letter designation, regardless of any letter designation following the reference number in the drawings, and a reference number without a particular letter designation refers to all elements having the same reference number. [Figure 1] FIG. 1 is a front perspective view of an embodiment of an intraoral phototherapy system including an intraoral phototherapy device and an intraoral phototherapy device protection system having a breathing apparatus and a protective sleeve. [Figure 2] 2 is a front perspective view of the intraoral phototherapy device and an exploded view of the breathing device of FIG. 1. [Figure 3] FIG. 3 is a front perspective view of the intraoral phototherapy device separated from the respiratory device of FIGS. 1 and 2 . [Figure 4] FIG. 2 is a front perspective view of the breathing apparatus and protective sleeve of FIG. 1; [Figure 5] FIG. 10 is a front perspective view of an alternative embodiment of a breathing apparatus. [Figure 6] FIG. 6 is a side perspective view of the breathing apparatus of FIG. 5. [Figure 7] FIG. 7 is a rear perspective view of the breathing apparatus of FIGS. 5 and 6; [Figure 8] FIG. 8 is a bottom perspective view of the breathing apparatus of FIGS. 5 to 7. [Figure 9] FIG. 9 is a front perspective view of the underside of the breathing apparatus of FIGS. 5 to 8. [Figure 10] FIG. 10 is a bottom perspective view of the bottom portion of FIG. 9 . [Figure 11] FIG. 11 is a side perspective view of the underside portion of FIGS. 9 and 10; [Figure 12] FIG. 9 is a front perspective view of the top portion of the breathing apparatus of FIGS. 5 to 8. [Figure 13] FIG. 13 is a bottom perspective view of the upper surface portion of FIG. 12 . [Figure 14] 14 is a side perspective view of the top portion of FIGS. 12 and 13; FIG. [Figure 15] FIG. 1 is a front perspective view of an embodiment of an intraoral phototherapy device. [Figure 16] FIG. 16 is a top perspective view of the intraoral phototherapy device of FIG. 15 . [Figure 17] FIG. 17 is a bottom perspective view of the intraoral phototherapy device of FIGS. 15 and 16. [Figure 18] FIG. 18 is a side perspective view of the intraoral phototherapy device of FIGS. 15 to 17. [Figure 19] 16 is a front perspective view of the intraoral phototherapy device of FIG. 15 and the respiratory device of FIG. 5. [Figure 20] 16 is a side perspective view of the intraoral phototherapy device of FIG. 15 and the respiratory device of FIG. 5. [Figure 21] 16 is a top view of the intraoral phototherapy device of FIG. 15 and the respiratory device of FIG. 5. [Figure 22] 16 is a top elevational view of the intraoral phototherapy device of FIG. 15 and the respiratory device of FIG. 5. [Figure 23] 16 is a bottom elevational view of the intraoral phototherapy device of FIG. 15 and the respiratory device of FIG. 5. [Figure 24] FIG. 10 is a top view of the protective sleeve during manufacture. [Figure 25] A diagram of an unprocessed sleeve showing the location of cuts and connection of the cuts to form a protective sleeve. [Figure 26]1 shows a protective sleeve and a breathing apparatus including a breathing tube. [Figure 27] The breathing apparatus of Figure 26 being installed in the protective sleeve. [Figure 28] 28 is a top view of the protective sleeve and breathing apparatus of FIGS. 26 and 27. FIG. [Figure 29] 29 shows the intraoral phototherapy device being inserted into the protective sleeve of FIG. 28. [Figure 30] 10A-10C show an alternative embodiment of a breathing apparatus attached to a protective sleeve. [Figure 31] 1 illustrates an embodiment of a respiratory device attached to an intraoral phototherapy device. [Figure 32] FIG. 2 is a side perspective view of a light guide of the intraoral phototherapy device. [Figure 33] FIG. 33 is a side view of the ray guide of FIG. 32; [Figure 34] FIG. 33 is a top view of the ray guide of FIG. 32; [Figure 35] 33 is a bottom view of the ray guide of FIG. 32; [Figure 36] FIG. 33 is a top view of the ray guide of FIG. 32 inserted into the oral cavity. [Figure 37] FIG. 33 is a side view of the ray guide of FIG. 32 inserted into the oral cavity. DETAILED DESCRIPTION OF THE INVENTION

[0013] Embodiments provide an intraoral phototherapy device that improves illumination of the tonsillar region of the oral cavity. Oral tissue irradiation is particularly challenging in the back of the throat. This intraoral phototherapy device improves irradiation of these tissues by using a breathing tube to improve the patient's breathing. The breathing tube allows the patient to breathe through the mouth, which frees up the tonsillar area of ​​the oral cavity. Opening the tonsillar area allows light emitted from the intraoral phototherapy device to irradiate tissue located in the back of the throat.

[0014] Additionally, objects that come into contact with the back of the throat often trigger a gag reflex. This gag reflex reduces the available time for administering phototherapy and makes it difficult to deliver phototherapy deep into the throat. The intraoral phototherapy device can weaken the gag reflex by contacting the hard palate of the oral cavity with the dorsal fin so that the intraoral phototherapy device does not contact the further back of the oral cavity. That is, the intraoral phototherapy device may include a dorsal fin configured to contact a portion of the oral cavity distal to the pharynx such that a portion of the intraoral phototherapy device proximal to the throat does not contact the oral cavity and induce a gag reflex.

[0015] 1-4, an embodiment of a phototherapy system 10 for irradiating the tonsillar region of the oral cavity is shown. Phototherapy system 10 includes an intraoral phototherapy device 12 and an intraoral phototherapy device protection system 14. The intraoral phototherapy device protection system 14 includes a breathing device 16 and a sleeve 18 (also referred to as a protective sleeve).

[0016] The breathing device 16 improves the patient's breathing while undergoing phototherapy using the intraoral phototherapy device 12, thereby improving illumination of the tonsillar region of the patient's oral cavity during phototherapy. Without the breathing device 16, the patient may need to breathe through their nose, which constricts the back of the throat and makes it difficult to irradiate the tonsillar area. In contrast, when using the breathing device 16, the patient is able to breathe through their mouth, keeping the back of the throat open and improving irradiation of the tonsillar area.

[0017] As shown in FIGS. 5 to 14, the breathing apparatus 16 includes a fixed structure 20, a main body 22, and a bifurcated branched protrusion 24. The securing structure 20 mechanically engages with a mounting structure 26 of the intra-oral phototherapy device 12 such that the position of the respiratory device 16 is maintained relative to the intra-oral phototherapy device 12 . Body portion 22 has a central lumen 28 and a distal opening 30 of central lumen 28 . The bifurcated prong 24 has a first outer lumen 32, a second outer lumen 34 and a proximal opening 36. The proximal openings 36 include a first proximal opening 38 in the first outer lumen 32 and a second proximal opening 40 in the second outer lumen 34 . First outer lumen 32 and second outer lumen 34 are fluidly connected to central lumen 28 .

[0018] The proximal opening 36 is configured (e.g., shaped) to be received within the oral cavity when the intraoral phototherapy device 12 is positioned therein and the fixation structure 20 is mechanically engaged with the intraoral phototherapy device 12. Similarly, the distal opening 30 is configured (e.g., shaped) to be located outside the oral cavity when the intraoral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intraoral phototherapy device, thus fluidly connecting the oral cavity to the external environment via the central lumen, the first outer lumen, and the second outer lumen. That is, because the proximal opening 36 and the distal opening 30 are fluidly connected, and because the proximal opening 36 is located within the oral cavity and the distal opening 30 is located outside the oral cavity, the respiratory device 16 provides a flow path for the patient to breathe through the mouth (i.e., via the central lumen 28).

[0019] 24 and 25, the protection system 14 includes a sleeve 18. The more the interior volume of the sleeve 18 conforms to the intraoral phototherapy device 12, the more difficult it becomes to insert the intraoral phototherapy device 12 inside the sleeve 18. On the other hand, a larger interior volume to improve insertion of the intraoral phototherapy device 12 into the sleeve 18 also makes it more difficult for the patient to breathe through their mouth with the sleeved intraoral phototherapy device 12 inside their mouth. By configuring multiple connected volumes within the sleeve 18 (e.g., one volume for each protrusion of the light guide), the sleeve 18 can be made less loose, improving the patient's ability to breathe through their mouth.

[0020] The sleeve 18 is formed from an optically transparent sheet material and has a three-pronged interior volume 42 including a central volume 44 , a first outer volume 46 and a second outer volume 48 . The trifurcated interior volume 42 is formed by folding a sheet of material to form an upper sheet 50 and a lower sheet 52 connected by a closed distal edge 54 . The topsheet 50 and bottomsheet 52 overlap to form an open first outer edge 56 , an open second outer edge 58 and an open proximal edge 60 . The top sheet 50 and bottom sheet 52 are connected along a first outer edge 56 to form a closed first outer edge 62 . Similarly, the top sheet 50 and bottom sheet 52 are connected along a second outer edge 58 to form a closed second outer edge 64 .

[0021] Sheet material is removed from the closed distal edge 54 along the closed distal edge 54 to form the central volume 44 , the first outer volume 46 and the second outer volume 48 . That is, the first region 66 of the sheet material between the central volume 44 and the first outer volume 46 is removed, and the upper sheet 50 and the lower sheet 52 are connected along the boundary of the first region 66 . Similarly, a second region 68 of sheet material between the central volume 44 and the second outer volume 48 is removed, and the top sheet 50 and bottom sheet 52 are connected along the boundary of the second region 68 .

[0022] The connection of the top sheet 50 and bottom sheet 52 forms a seam along a first outer edge 62 and a second outer edge 64 . This seam may distort the light emitted by the intraoral phototherapy device 12. In contrast, the folds of sheet material forming the top sheet 50 and bottom sheet 52, which are connected by the closed distal edge 54, do not form a seam along the closed distal edge 54, and thus light passing through the closed distal edge is not interfered with by the seam. The top sheet 50 and bottom sheet 52 may be connected using any suitable method (eg, heat welding, adhesive, etc.).

[0023] The sleeve 18 may be formed in any manner such that the sleeve 18 does not include a seam along the distal edge 54 . For example, sleeve 18 may be dip-formed or vacuum-formed (eg, similar to a latex glove).

[0024] As shown in FIG. 1, the central volume 44 is shaped to accommodate the light guide 70 of the intraoral phototherapy device 12 . Similarly, the first outer volume 46 is shaped to accommodate the first outer wing 72 of the intraoral phototherapy device 12, and the second outer volume 48 is shaped to accommodate the second outer wing 74. The retaining structure 20 of the respiratory device 16 maintains the position of the sleeve 18 relative to the intraoral phototherapy device 12 when the retaining structure 20 is mechanically engaged with the intraoral phototherapy device 12 with the sleeve 18 positioned between the respiratory device 16 and the intraoral phototherapy device 12. That is, the respiratory device 16 may be used to positionally secure the sleeve 18 relative to the intraoral phototherapy device 12 .

[0025] The sleeve 18 may be formed from any suitable material. For example, the sleeve 18 may be disposable and may be formed from a synthetic resin that is sufficiently biocompatible to act as a microbial barrier between the oral cavity and the light guide 70 .

[0026] As shown in Figures 26-31, the breathing apparatus 16 may have a variety of configurations. For example, the respiratory apparatus 16 may lack a body portion and instead include at least one respiratory tube 122 . In the illustrated embodiment, the respiratory apparatus 16 includes two respiratory tubes 122a, 122b, each having a proximal opening in fluid communication with a distal opening. One or more respiratory tubes 122 may not be fluidly connected to one another (eg, one or more respiratory tubes 122 may be physically separated).

[0027] The respiratory tube(s) 122 may be mechanically attached to the sleeve 18 or may be free-floating. The one or more breathing tubes 122 may be bendable to allow for repositioning of the one or more distal openings (located outside the oral cavity) relative to the one or more proximal openings. Alternatively, one or more of the breathing tubes 122 may have a fixed shape.

[0028] The one or more respiratory tubes 122 may be secured to the sleeve 18 using tape, by heat welding a portion of the sleeve 18 material to the sleeve 18, or by using any suitable method. For example, the breathing apparatus 16 may be integrated into the sleeve 18 such that the breathing apparatus 16 is mechanically secured to the sleeve 18 . The sleeve 18 may be sterilized.

[0029] In the embodiment shown in Figures 30 and 31, an alternative embodiment of a breathing tube is shown. In both embodiments, the respiratory tube 122 is folded and attached to the surface of the sleeve via a clip 124 . As shown, one or more breathing tubes 122 may be positioned in various positions and / or orientations (eg, vertically or horizontally) relative to the intraoral phototherapy device 12.

[0030] In one embodiment, the respiratory device 16 may include one or more protrusions that engage with one or more recesses in the intraoral phototherapy device 12 to maintain the position of the respiratory device 16 relative to the intraoral phototherapy device 12.

[0031] The breathing device 16 may be configured so as not to interfere with the patient's breathing. In one embodiment, one or more proximal openings of the respiratory apparatus 16 may have a cross-sectional area that allows for a tidal volume (Vt) of greater than 300 ml. Tidal volume is defined as the volume of air that enters and leaves the lungs during each respiratory cycle (inspiration / exhalation). The breathing apparatus 16 may be configured to allow the patient to flow at least 300 ml of air through the breathing apparatus 16 during a 5 minute treatment without increasing respiratory effort.

[0032] An embodiment of an intraoral phototherapy device 12 that irradiates a target area of ​​the oral cavity with light emitted by a light source 75 is shown in FIGS. The intraoral phototherapy device 12 includes a light guide 70 having a proximal end 76, a distal end 78, a dorsal portion 80, a ventral portion 82, and a body portion 84 extending between the proximal end 76, the distal end 78, the dorsal portion 80, and the ventral portion 82.

[0033] Light guide 70 receives light rays from light source 75 at proximal end 76 and transmits the received light rays from proximal end 76 to distal end 78 through body 84 . Body portion 84 includes light extraction features 86 that allow light rays to emanate from dorsal portion 80 and ventral portion 82 . The light guide 70 also projects light rays from its distal end 78 . The dorsal portion 80 may have a convex shape and the ventral portion 82 may have a concave shape, such that the body portion 84 conforms to the contours of the oral cavity upon insertion therein to guide the light beam to the target area of ​​the oral cavity.

[0034] The light guide 70 also includes a rear projection 88 extending from the rear portion 80 that presses against the roof of the oral cavity when the intraoral phototherapy device 12 is inserted into the oral cavity. By interacting with the roof of the mouth, the rear projections 88 maintain a space between the roof of the mouth and the rear portion 80 of the intraoral phototherapy device 12, as shown in FIG.

[0035] As shown, the dorsal projection 88 is configured to interact with the hard palate and reduce pressure of the tip (ie, distal end 78) of the light guide 70 against the upper back of the throat. This improves illumination of the soft palate (also called tonsillar tissue) during phototherapy.

[0036] The dorsal projection 88 may have any suitable shape that cushions the distal end 78 from pressing against the upper back of the throat and interacts with the hard palate. For example, in the drawing, the rear projection 88 has a fin shape. The rear projections 88 are not limited to a fin shape and may have any suitable shape (eg, spherical, elliptical, oblong, etc.).

[0037] As described above, the intraoral phototherapy device 12 may also include outer wings 72, 74. The outer wings 72 and 74 are optically coupled to the light guide 70 to receive and transmit light rays from the light source 75 . The first outer wing portion 72 (also referred to as the left wing portion) and the second outer wing portion 74 (also referred to as the right wing portion) are vertically spaced apart, and the light guide 70 is located vertically between the first outer wing portion 72 and the second outer wing portion 74. As shown in FIG. 36, the outer wings 72, 74 are sized and shaped to be received within the patient's mouth between the cheek tissue and gums. That is, the outer wings 72, 74 include an inner surface 90 that faces the gums when inserted into the oral cavity, and an outer surface 92 opposite the inner surface 90 that faces the cheek tissue. The outer wings 72, 74 direct the received light rays from the inner surface 90 and the outer surface 92.

[0038] 19 to 23, the bifurcated branched protrusion 24 may include a first outer protrusion 94 surrounding the first outer lumen 32 and a second outer protrusion 96 surrounding the second outer lumen . The first outer protrusion 94 can be spaced from the second outer protrusion 96 such that when the respiratory device is mechanically engaged with the intraoral phototherapy device, the central protrusion of the intraoral phototherapy device is located between the first outer lumen and the second outer lumen.

[0039] 9 to 14, the fixed structure 20, the main body 22 and the bifurcated protrusion 24 may be integrally formed by a housing 98 having an upper surface portion 100 and a lower surface portion 102. The lower surface portion 102 and the upper surface portion 100 may be shaped to mechanically engage to form the central lumen 28, the first outer lumen 32 and the second outer lumen 34. For example, the upper and lower portions 100, 102 may snap fit together. In the illustration, the lower surface 102 includes tabs that engage slots located in the upper surface 100 .

[0040] The bifurcated prong 24 may include a first peripheral opening 104 in the first outer lumen 32 and a second peripheral opening 106 in the second outer lumen 34 . The first peripheral opening 104 may be located on a different plane than the first proximal opening 38 . Similarly, the second peripheral opening 106 may be located on a different plane than the second proximal opening 40 . For example, in FIG. 5, the first peripheral opening 104 lies in a plane perpendicular to the first proximal opening 38 . The peripheral openings 104 , 106 may be used to improve airflow through the breathing apparatus 16 .

[0041] 32-37, the light extraction features 86 may include back features 108 in a distal region 110 of the back portion 80 adjacent the distal end 78. The back feature 108 may include at least one of a protrusion or a depression in the back portion 80 . At least a portion of the dorsal projection 88 may be located in a distal region 110 of the dorsal portion 80 . For example, the distal region 110 may comprise one-third, one-quarter, one-fifth, or any suitable portion of the back portion 80 of the light guide 70 . The ray extraction features 86 may include a ventral feature 112 in the ventral portion 82 . Ventral surface feature 112 may include at least one of a protrusion or a depression in ventral surface 82 .

[0042] The distal end 78 may include projection optical features configured to guide light rays from the distal end 78 to the tonsillar tissue. For example, the distal end 78 of the light guide 70 may be contoured to at least partially focus the light rays exiting the distal end 78 . That is, distal end 78 may be configured to emit a more concentrated beam of light from ray guide 70 (eg, as shown in FIGS. 32-35). The projection optical features may include any suitable optical structure, for example, surface shaping, lensing, surface aberrations, and the like.

[0043] The ventral surface portion 82 of the light guide 70 has a curvature that matches the contour of the dorsal surface of the tongue so that the light emitted from the ventral surface portion 82 illuminates the dorsal surface of the tongue. The light guide 70 may be contoured to improve patient comfort by following the curves of the palate and / or tongue of the mouth.

[0044] Ray extraction features 86 may be any suitable structure for extracting light rays from a ray guide (eg, for a particular light output distribution). For example, the ray extraction features 86 may include at least one of a surface aberration, a microlens, a reflective spot, a partially reflective plane, or a diffraction grating. Alternatively or additionally, a diffusing sheet or a 2D lensing sheet may be placed on the emitting surface of the light guide. And the surface aberration includes at least one of a surface profile, a surface coating, or a surface etching.

[0045] As shown in FIG. 2, the light source 75 may be external to the light guide 70 or the casing 114 to which the light guide 70 is mechanically attached, and may not be physically supported by the light guide 70 or the casing 114. For example, light source 75 may be a light box supported by an external structure (eg, a table) that is optically connected to light guide 70 via optical cables 116 (eg, optical fibers). Alternatively, the light source 75 may be physically supported by the casing 114 . For example, light source 75 may be housed in casing 114 and powered by a power source (eg, a battery) that is electrically connected to light source 75 . Alternatively or additionally, light source 75 may be mechanically supported by light guide 70 (eg, a light emitting diode (LED) integrated into and / or attached to light guide 70). In another example, the light source may be physically mounted to a tab (eg, a protrusion) on the outer surface of the light guide.

[0046] And, the casing 114 of the intraoral phototherapy device 12 includes an interface 126 for receiving the body portion 22 of the respiratory apparatus 16 . As shown in FIGS. 15, 16 and 18, the interface 126 may be a recess or depression shaped to receive a portion of the body portion 22 therein.

[0047] The light source is a remote light source optically connected to the rearwardly projecting end of the light guide via a fiber optic cable. And the remote light source includes one or more LEDs or lasers.

[0048] Light source 75 may be any suitable structure that emits light. For example, the light source 75 may include one or more light emitting diodes (LEDs), organic LEDs (OLEDs), micro LEDs, laser diodes, mini LEDs, quantum dot (QD) conversion, phosphor conversion, excimer lamps, multi-photon combinations, SLM wavefront manipulation. The light source 75 may emit light rays (also called electromagnetic radiation) having wavelengths between 600 nm and 1000 nm. For example, the light source 75 may emit light having a wavelength substantially equal to at least one of 630 nm, 660 nm, 670 nm, 810 nm, or 880 nm.

[0049] The intraoral phototherapy device 12 may be configured to irradiate a target area 118 of the oral cavity that includes tissue in addition to tonsillar tissue. For example, the target area 118 of the oral cavity may include tonsillar tissue and at least one of the tongue, the mandibular and maxillary buccal surfaces of the oral cavity, the floor and palate of the oral cavity, and tonsillar tissue. Target areas 118 of the oral cavity include the tongue, the mandibular and maxillary buccal surfaces of the oral cavity, the floor and palate of the oral cavity, and tonsillar tissue.

[0050] The light guide 70 may be formed from any suitable material that is at least partially transparent to the light rays 120 emitted by the light source 75 . For example, the light guide may be formed from an optically transparent, soft, flexible, biocompatible polymeric material, such as silicone. By way of example, the light guide may be formed from various formulations of polycarbonate, polymethyl methacrylate, polystyrene, nylon, acrylonitrile butadiene styrene, polyolefins or other biocompatible thermoplastic elastomer formulations.

[0051] Intraoral phototherapy devices may be used in many applications, examples of which include oral mucositis, acute necrotizing gingivitis, periodontal disease, trismus, shortening recovery time from oral surgery, orthodontic light delivery, and photodynamic therapy, for example, to activate chemical mouthwashes.

[0052] In the phototherapy system 10, the intraoral phototherapy device 12 includes a light guide 70 having a proximal end 76, a distal end 78, a dorsal portion 80, a ventral portion 82, and a body portion 84 extending between the proximal end 76, the distal end 78, the dorsal portion 80, and the ventral portion 82. The light guide 70 receives light rays 120 from the light source 75 at the proximal end 76 and propagates the received light rays 120 from the proximal end 76 to the distal end 78 through the body 84 . Body portion 84 includes light extraction features 86 that allow light rays to emanate from dorsal portion 80 and ventral portion 82 . The light guide 70 projects light rays from a distal end 78 . The light guide 70 may have any suitable shape for projecting light into the oral cavity, for example, spherical, elliptical, S-shaped, etc.

[0053] This embodiment of the phototherapy system 10 also includes a respiratory device 16 having a fixation structure 20 that mechanically engages the mounting structure of the intraoral phototherapy device 12, and a body portion 22 having a central lumen 28, a distal opening 30 of the central lumen 28, and a proximal opening 36 of the central lumen 28. For example, the breathing apparatus 16 may include a single breathing tube 122 . As an example, the breathing apparatus 16 may be a single breathing apparatus located above, below, and to the side of the light guide 70 . As another example, the light guide 70 may have a central opening and the breathing tube 122 may be formed in or located at this central opening.

[0054] All range and ratio limits disclosed in the specification and claims may be combined in any order. Unless specifically stated otherwise, references to "a," "an," and / or "the" may include one or more than one, and references to a singular item may include a plural of that item.

[0055] Although the present invention has been illustrated and described, equivalent modifications and alterations will occur to others skilled in the art upon reading and understanding this specification and the accompanying drawings. In particular, with regard to the various functions performed by the above elements (components, assemblies, devices, compositions, etc.), the terms used to describe such elements (including references to "means") are intended, unless otherwise specified, to correspond to any element that performs the specified function of the described element, even if it is not structurally equivalent to the disclosed configuration that performs that function in one or more embodiments of the present invention described in this disclosure (i.e., it is functionally equivalent). Also, while particular features of the invention may be described in only one or more of the described embodiments, such features may be combined with features of other embodiments as desired or to advantage for any given or particular application.

Claims

1. 1. A respiratory device that improves patient breathing while undergoing phototherapy using an intraoral phototherapy device, thereby improving illumination of the tonsillar region of a patient's oral cavity during phototherapy, the device comprising: a securing structure configured to mechanically engage a mounting structure of the intraoral phototherapy device such that the position of the respiratory apparatus is maintained relative to the intraoral phototherapy device; and a body portion including first and second outer lumens within the oral cavity, a first proximal opening of the first outer lumen near the tonsil region and a first distal opening of the first outer lumen far from the tonsil region, and a second proximal opening of the second outer lumen near the tonsil region and a second distal opening of the second outer lumen far from the tonsil region; the first proximal opening and the second proximal opening are configured to be received within the oral cavity when the intraoral phototherapy device is positioned within the oral cavity and the fixation structure is mechanically engaged with the intraoral phototherapy device; the first distal opening and the second distal opening are configured to be located outside the oral cavity when the intraoral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intraoral phototherapy device; The respiratory apparatus, wherein the oral cavity is fluidly connected to an external environment via the first outer lumen and the second outer lumen.

2. 10. The respiratory apparatus of claim 1, wherein the body portion has a central lumen and a distal opening of the central lumen distal to the tonsillar region.

3. 1. An intraoral phototherapy device protection system for providing a barrier between a receiving light guide and a patient's oral cavity, comprising: A breathing apparatus according to claim 1 or claim 2; a sleeve formed from an optically transparent sheet material and having a three-pronged interior volume including a central volume, a first outer volume, and a second outer volume, the three-pronged interior volume comprising: folding the sheet material to form a top sheet and a bottom sheet connected by a closed distal edge, the top sheet and the bottom sheet overlapping to form an open first outer edge, an open second outer edge, and an open proximal edge; the top sheet and the bottom sheet are connected along the open first outer edge to form a closed first outer edge; the top sheet and the bottom sheet are connected along the open second outer edge to form a closed second outer edge; removing sheet material from and along the closure distal edge to form the central volume, the first outer volume, and the second outer volume; by removing a first region of sheet material between the central volume and the first outer volume and connecting the top sheet and the bottom sheet along a boundary of the first region; and removing a second region of sheet material between the central volume and the second outer volume by connecting the top sheet and the bottom sheet along a boundary of the second region. is formed by the central volume is shaped to accommodate a light guide of the intraoral phototherapy device; the first outer volume is shaped to accommodate a first outer wing of the intraoral phototherapy device; the second outer volume is shaped to accommodate a second outer wing of the intraoral phototherapy device; the securing structure of the respiratory device is configured to maintain the position of the sleeve relative to the intraoral phototherapy device when the securing structure is mechanically engaged with the intraoral phototherapy device.

4. the connection of the top sheet and the bottom sheet along the open first outer edge to form the open first outer edge forms a seam along the open first outer edge; the connection of the top sheet and the bottom sheet along the open second outer edge to form the open second outer edge forms a seam along the open second outer edge; 4. The intraoral phototherapy device protection system of claim 3, wherein the folds of the sheet material forming the top sheet and the bottom sheet connected by the closure distal edge do not form a seam along the closure distal edge, and thus light passing through the closure distal edge is not interfered with by a seam.

5. 4. The intraoral phototherapy device protection system of claim 3, wherein the respiratory device is integrated into the sleeve such that the respiratory device is mechanically secured to the sleeve.

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