US-20260124461-A1 - INTRAORAL PHOTOTHERAPY DEVICE

US20260124461A1US 20260124461 A1US20260124461 A1US 20260124461A1US-20260124461-A1

Abstract

An intraoral phototherapy device is provided that improves illumination of a tonsillar region of the oral cavity. Oral tissue illumination is particularly difficult in the back of the throat. The intraoral phototherapy device improves illumination of these tissues by using a breathing tube to improve patient breathing. The breathing tube allows a patient to breathe through their mouth, which opens up the tonsillar region of the oral cavity. Additionally, objects contacting near the back of the throat often induce a gagging reflex. This gagging reflex shortens the time available to perform phototherapy, making it difficult for phototherapy to be delivered to the back of the throat. The intraoral phototherapy device may reduce the gagging reflex by contacting the hard palate of the oral cavity with a dorsal fin, such that the intraoral phototherapy device does not make contact further back in the oral cavity.

Inventors

Vedang Kothari
Jordan Oja
Jason LAZZARA
Samuel SHELNUTT

Assignees

Mureva Phototherapy Inc.

Dates

Publication Date: 20260507
Application Date: 20220909

Claims (20)

1 . A breathing apparatus for improving illumination of a tonsillar region of an oral cavity of a patient during phototherapy by improving patient breathing while receiving the phototherapy with an intra-oral phototherapy device, wherein the breathing apparatus includes: a fixation structure configured to mechanically engage with a mounting structure of the intra-oral phototherapy device, such that a position of the breathing apparatus is maintained relative to the intra-oral phototherapy device; a main body including a first lateral lumen, a second lateral lumen, a first proximal opening and a first distal opening to the first lateral lumen, and a second proximal opening and a second distal opening to the second lateral lumen, wherein: the first proximal opening and the second proximal opening are configured to be received within the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device; and the first distal opening and the second distal opening are is configured to be located outside of the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device, such that the oral cavity is fluidly coupled with an external environment via the first lateral lumen, and the second lateral lumen.
2 . The breathing apparatus of claim 1 , wherein: the first lateral lumen and the second lateral lumen are included in a bifurcated protrusion; the bifurcated protrusion includes a first lateral protrusion enclosing the first lateral lumen and a second lateral protrusion enclosing the second lateral lumen; and the first lateral protrusion is separated from the second lateral protrusion, such that a central protrusion of the intra-oral phototherapy device is positioned between the first lateral protrusion and the second lateral protrusion when the breathing apparatus is mechanically engaged with the intra-oral phototherapy device.
3 . The breathing apparatus of claim 1 , wherein: the fixation structure, the main body, and the bifurcated protrusion are monolithically formed by a housing having a top piece and a bottom piece; and the bottom piece and the top piece are shaped to mechanically engage to form the central lumen, the first lateral lumen, and the second lateral lumen.
4 . The breathing apparatus of claim 1 , wherein: the bifurcated protrusion further includes a first peripheral opening to the first lateral lumen and a second peripheral opening to the second lateral lumen; the first peripheral opening is located in a different plane than the first proximal opening; and the second peripheral opening is located in a different plane than the second proximal opening.
5 . An intra-oral phototherapy device protection system for providing a barrier between the received light guide and an oral cavity of a patient, the system comprising: the breathing apparatus of claim 1 ; a sleeve formed from an optically transparent sheet material and having a trifurcated interior volume including a central volume, a first lateral volume, and a second lateral volume, wherein the trifurcated interior volume is formed by: folding over the sheet material to form a top sheet and a bottom sheet connected by a closed distal edge, wherein the top sheet and the bottom sheet overlap to form an open first lateral edge, an open second lateral edge, and an open proximal edge; connecting the top sheet and the bottom sheet along the first lateral edge to form a closed first lateral edge; connecting the top sheet and the bottom sheet along the second lateral edge to form a closed second lateral edge; removing sheet material from along the closed distal edge to form the central volume, the first lateral volume, and the second lateral volume by: removing a first area of material between the central volume and the first lateral volume and connecting the top sheet and the bottom sheet along a border of the first area; and removing a second area of material between the central volume and the second lateral volume and connecting the top sheet and the bottom sheet along a border of the second area; wherein the central volume is shaped to receive a light guide of the intra-oral phototherapy device; wherein the first lateral volume is shaped to receive a first lateral wing of the intra-oral phototherapy device; and wherein the second lateral volume is shaped to receive a second lateral wing of the intra-oral phototherapy device; and wherein the fixation structure of the breathing apparatus is configured to maintain a position of the sleeve relative to the intra-oral phototherapy device when the fixation structure is mechanically engaged with the intra-oral phototherapy device.
6 . The system of claim 5 , wherein: the connecting of the top sheet and the bottom sheet along the first lateral edge to form the first lateral edge forms a seam along the first lateral edge; the connecting of the top sheet and the bottom sheet along the second lateral edge to form the second lateral edge forms a seam along the second lateral edge; the folding over of the sheet material to form the top sheet and the bottom sheet connected by the closed distal edge does not form a seam along the closed distal edge, such that light transmitted through the closed distal edge is not interfered with by a seam.
7 . The system of claim 5 , wherein the breathing apparatus is integrated into the sleeve such that the breathing apparatus is mechanically fixed to the sleeve.
8 . An intraoral phototherapy device for illuminating targeted regions of an oral cavity of a patient with light emitted by a light source, the device comprising: a light guide having a proximal end, a distal end, a dorsal surface, a ventral surface, and a main body extending between the proximal end, the distal end, the dorsal surface, and the ventral surface, wherein: the light guide is configured to receive light from the light source at the proximal end and to propagate the received light from the proximal end to the distal end via the main body; the main body includes light extracting features configured to cause light to be emitted from the dorsal surface and the ventral surface; the light guide is configured to project light from the distal end; the dorsal surface has a convex shape and the ventral surface has a concave shape, such that the main body conforms to contours of the oral cavity when inserted therein to direct light to targeted regions of the oral cavity; and a dorsal projection extending from the dorsal surface and configured to push against a roof of the oral cavity when the intra-oral phototherapy device is inserted into the oral cavity.
9 . The device of claim 8 , wherein: the light-extracting features includes dorsal surface features at a distal region of the dorsal surface adjacent the distal end; the dorsal surface features include at least one of projections or depressions in the dorsal surface; and at least a portion of the dorsal projection is located in the distal region of the dorsal surface.
10 . The device of claim 8 , wherein the light-extracting features include ventral surface features on the ventral surface and the ventral surface features include at least one of projections or depressions in the ventral surface.
11 . The device of claim 8 , wherein the light source is external to and not physically supported by the light guide.
12 . The device of claim 8 , wherein the targeted regions of the oral cavity include at least one of the tongue, mandibular and maxillary buccal surfaces of the oral cavity, the floor and roof of the oral cavity, and tonsillar tissues.
13 . The device of claim 8 , wherein the targeted regions of the oral cavity include the tongue, mandibular and maxillary buccal surfaces of the oral cavity, the floor and roof of the oral cavity, and tonsillar tissues.
14 . The device of claim 8 , wherein the light guide is made of a material that is at least partially transparent to light emitted by the light source.
15 . The device of claim 8 , further comprising: lateral wings optically coupled to the light guide and configured to receive and propagate the light from the light source, wherein: the lateral wings include a left wing and a right wing vertically spaced from the left wing; and the light guide is positioned vertically between the left wing and the right wing; the lateral wings are sized and shaped to be received between buccal tissues and gums of the patient; and the lateral wings include an inner surface facing towards the gums and an outer surface opposite the inner surface facing towards the buccal tissues when inserted into the oral cavity, wherein the lateral wings are configured to emit the received light from the inner surface and the outer surface.
16 . A phototherapy system for illumination a tonsillar region of an oral cavity of a patient by improving patient breathing while receiving the phototherapy, wherein the system comprises: the intra-oral phototherapy device of claim 8 , further comprising a mounting structure; and a breathing apparatus including: a fixation structure configured to mechanically engage with the mounting structure of the intra-oral phototherapy device, such that a position of the breathing apparatus is maintained relative to the intra-oral phototherapy device; a main body including a first lateral lumen, a second lateral lumen, a first proximal opening and a first distal opening to the first lateral lumen, a second proximal opening and a second distal opening to the second lateral lumen, wherein: the first lateral lumen and the second lateral lumen are shaped such that the light guide is positioned vertically between the first lateral lumen and the second lateral lumen when the fixation structure is mechanically engaged with the intra-oral phototherapy device; the first proximal opening and the second proximal opening are is configured to be received within the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device; and the first distal opening and the second distal opening are is configured to be located outside of the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device, such that the oral cavity is fluidly coupled with an external environment via the first lateral lumen, and the second lateral lumen.
17 . The system of claim 16 , further comprising: a sleeve formed from an optically transparent sheet material and having a trifurcated interior volume including a central volume, a first lateral volume, and a second lateral volume, wherein the trifurcated interior volume is formed by: folding over the sheet material to form a top sheet and a bottom sheet connected by a closed distal edge, wherein the top sheet and the bottom sheet overlap to form an open first lateral edge, an open second lateral edge, and an open proximal edge; connecting the top sheet and the bottom sheet along the first lateral edge to form a closed first lateral edge; connecting the top sheet and the bottom sheet along the second lateral edge to form a closed second lateral edge; removing sheet material from along the closed distal edge to form the central volume, the first lateral volume, and the second lateral volume by: removing a first area of material between the central volume and the first lateral volume and connecting the top sheet and the bottom sheet along a border of the first area; and removing a second area of material between the central volume and the second lateral volume and connecting the top sheet and the bottom sheet along a border of the second area; wherein the central volume is shaped to receive the light guide of the intra-oral phototherapy device; wherein the first lateral volume is shaped to receive a first lateral wing of the intra-oral phototherapy device; and wherein the second lateral volume is shaped to receive a second lateral wing of the intra-oral phototherapy device; and wherein the fixation structure of the breathing apparatus is configured to maintain a position of the sleeve relative to the intra-oral phototherapy device when the fixation structure is mechanically engaged with the intra-oral phototherapy device.
18 . The system of claim 17 , wherein: the connecting of the top sheet and the bottom sheet along the first lateral edge to form the first lateral edge forms a seam along the first lateral edge; the connecting of the top sheet and the bottom sheet along the second lateral edge to form the second lateral edge forms a seam along the second lateral edge; the folding over of the sheet material to form the top sheet and the bottom sheet connected by the closed distal edge does not form a seam along the closed distal edge, such that light transmitted through the closed distal edge is not interfered with by a seam.
19 . A phototherapy system for illuminating a tonsillar region of an oral cavity of a patient by improving patient breathing while receiving the phototherapy, wherein the system comprises: an intraoral phototherapy device for illuminating targeted regions of an oral cavity of a patient with light emitted by a light source, the device comprising: a light guide having a proximal end, a distal end, a dorsal surface, a ventral surface, and a main body extending between the proximal end, the distal end, the dorsal surface, and the ventral surface, wherein: the light guide is configured to receive light from the light source at the proximal end and to propagate the received light from the proximal end to the distal end via the main body; the main body includes light extracting features configured to cause light to be emitted from the dorsal surface and the ventral surface; the light guide is configured to project light from the distal end; a breathing apparatus including: a fixation structure configured to mechanically engage with the mounting structure of the intra-oral phototherapy device, such that a position of the breathing apparatus is maintained relative to the intra-oral phototherapy device; and a main body having a central lumen, a distal opening to the central lumen, and a proximal opening to the central lumen, wherein: the proximal opening is configured to be received within the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device; and the distal opening is configured to be located outside of the oral cavity when the intra-oral phototherapy device is located within the oral cavity and the fixation structure is mechanically engaged with the intra-oral phototherapy device, such that the oral cavity is fluidly coupled with an external environment via the central lumen, the first lateral lumen, and the second lateral lumen.
20 . The system of claim 19 , wherein: the main body further includes a bifurcated protrusion; the bifurcated protrusion includes the proximal opening, a first lateral lumen, and a second lateral lumen; the proximal opening comprises a first proximal opening to the first lateral lumen and a second proximal opening to the second lateral lumen; the first lateral lumen and the second lateral lumen are fluidly coupled to the central lumen; and the first lateral lumen and the second lateral lumen are shaped such that the light guide is positioned vertically between the first lateral lumen and the second lateral lumen when the fixation structure is mechanically engaged with the intra-oral phototherapy device.

Description

RELATED APPLICATIONS This application claims the benefit of 63/242,166 filed on Sep. 9, 2021. Which is herein incorporated by reference in its entirety. TECHNICAL FIELD This present disclosure relates generally to phototherapy and more particular to intraoral phototherapy devices. BACKGROUND Phototherapy can be utilized for treating and providing pain relief for various conditions, including a condition called Oral Mucositis (OM). Phototherapy can be delivered in several ways, e.g., directly to the tissue via Low Level Laser Therapy (LLLT) or via a light emitting diode (LED) array that propagates light through the skin into the affected region. Currently there are two known methods for administering phototherapy for the treatment of various phototherapy treatment conditions of the mouth including, but not limited to Oral Mucositis (OM), low level laser therapy and light emitting diode (LED) arrays. Oral Mucositis is one of the most common and highly significant toxicities of cancer therapy. Barriers to the acceptance of low-level laser therapy include the cost of laser equipment and the labor intensiveness. Additionally, there are problems with interoperator variability and the need for specialized training. Also, patients receiving this form of treatment are required to hold their mouths open for long periods of time which is uncomfortable and becomes extremely painful as the Mucositis progresses. LED arrays utilize a plurality of LEDs to irradiate larger areas of tissue externally. The light from these arrays penetrates the skin to stimulate the mucosal membrane. LED arrays have the advantage of irradiating a large surface area, are simpler to implement than spot laser systems, and are more comfortable to the patient. The main disadvantages of using LED arrays for administering phototherapy treatment is that they lack dose control because they must transilluminate cheek tissue and have difficulty reaching all regions of the oral cavity, including the tonsillar and palatal regions which are highly susceptible to OM. Also, variability in tissue thickness between different buccal regions and different patients makes it impossible to accurately monitor and control the dose of light administered to the mucosa. SUMMARY Many patients experience painful lesions at the back of the throat and tonsillar region of the oral cavity caused by oral mucositis. However, it is difficult to treat these effected areas because it is difficult to reach these areas with phototherapeutic light. The present disclosure provides an intraoral phototherapy device for illuminating a tonsillar region of the oral cavity by using a breathing tube to improve patient breathing and, consequently, open up the tonsillar region for improve illumination of tissues located at the back of the throat. The present disclosure also provides an intraoral phototherapy device for illuminating a tonsillar region of the oral cavity by using a dorsal projection to interact with the roof of the oral cavity, reducing gagging and opening up the tonsillar region for improve illumination of tissues located at the back of the throat. The present disclosure also provides a trifurcated sleeve for receiving an intraoral phototherapy device for providing a barrier between the intraoral phototherapy device and the oral cavity, while maintaining the sleeve near the intraoral phototherapy device to improve patient breathing and, consequently, open up the tonsillar region for improved illumination of tissues located at the back of the throat. While several features are described herein with respect to embodiments of the invention; features described with respect to a given embodiment also may be employed in connection with other embodiments. The following description and the annexed drawings set forth certain illustrative embodiments of the invention. These embodiments are indicative, however, of but a few of the many ways in which the principles of the invention may be employed. Other objects, advantages, and novel features according to aspects of the invention will become apparent from the following detailed description when considered in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS The annexed drawings, which are not necessarily to scale, show various aspects of the invention in which similar reference numerals are used to indicate the same or similar parts in the various views. FIG. 1 is a front perspective view of an embodiment of an intraoral phototherapy system including an intra-oral phototherapy device and an intra-oral phototherapy device protection system having a breathing apparatus and a protective sleeve. FIG. 2 is a front perspective view of the intra-oral phototherapy device and an exploded view of the breathing apparatus of FIG. 1. FIG. 3 is a front perspective view of the intra-oral phototherapy device separated from the breathing apparatus of FIGS. 1 and 2. FIG. 4 is a front perspective view of the breathing apparatus and the protec