Systems, devices, and methods for reducing a temperature of a user's mouth and surrounding tissue

Abstract

Mouth-cooling devices for absorbing heat from a user's mouth prior to, during, and / or after receiving treatment with chemotherapy may assist with reducing incidences of and / or mitigating pain and discomfort caused by oral mucositis that may result from receiving chemotherapy treatments. The mouth-cooling devices may include a plurality of components sized, shaped, and / or configured to fit within a user's mouth to cool oral tissue from inside and / or outside the user's oral cavity. In some instances, the mouth-cooling devices may have a body configured to fit within the user's oral cavity proximate to tissue so that it may absorb heat from the tissue. The mouth cooling devices may also have an external component coupled to the body. The external component may be sized, shaped, and / or configured to sit outside the user's lips and / or cheeks.

Description

SYSTEMS, DEVICES, AND METHODS FOR REDUCING A TEMPERATURE OF A USER’S MOUTH AND SURROUNDING TISSUERELATED APPLICATION DATA

[0001] This patent application is a NON-PROVISIONAL patent application claiming benefit of and priority to U.S. Provisional Patent Application No.63 / 723,424, filed November 21 , 2024, and entitled “INTRAORAL COOLING DEVICE FOR DECREASING ORAL CAVITY TEMPERATURE,” the entire disclosure of which is incorporated in its entirety herein.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0002] This invention was made with Government support under Contract P50 FD0006424 awarded by the Food and Drug Administration. The Government has certain rights in the invention.FIELD OF THE DISCLOSURE

[0003] The present disclosure is a medical device configured to cool the oral cavity, which may prevent oral mucositis (e.g., inflammation and ulceration of oral mucosa or oral tissue) as may occur during, or following, certain medical treatments such as infusion with chemotherapy drugs and / or exposure to radiotherapy.BACKGROUND

[0004] Inflammation of oral mucosa, oral tissue, and formation of ulcers or mouth sores, which is sometimes referred to as “oral mucositis” (OM) is a painful and debilitating medical condition that may be caused by, for example, autoimmune conditions, infectious diseases (e.g., COVID and herpes), and / or may be a result of chemotherapy and / or radiotherapy. For example, OM affects over 40% of patients receiving chemotherapy for all types of cancer treatment and 90% of patients at high-risk of developing OM, such as those receiving treatment for head & neck cancer and / or receiving stem cell transplants because the chemotherapy damages of the cells of the oral mucosa and tissue. OM causes significant pain and impairs normal oral functions (e.g., speaking, eating, and / or swallowing), which canlead to malnutrition, dehydration, and / or infections. These complications cause a major decline in quality of life and health for affected populations, which often require additional treatments and, in particularly severe cases, hospitalization.

[0005] The current standard of care for treating OM is primarily palliative and supportive, aimed at providing pain relief (e.g., topical analgesia and / or opioid analgesics), reducing inflammation (e.g., benzydamine and / or honey), increasing nutritional intake (e.g., total parenteral nutrition (TPN) and / or nasogastric tube insertion), and / or decreasing infection risks (e.g., use of antibiotic mouthwashes). However, these treatments are often ineffective and do not prevent, or reduce a severity of, OM. At times, OM treatment requires changes in administration (e.g., dosage and / or frequency of infusion) of chemotherapy and / or radiation, which may disrupt cancer treatment and / or negatively impact cancer recovery outcomes.

[0006] Traditionally, the oral cryotherapy to prevent and / or mitigate OM is provided using ice chips and / or chilled water. However, use of ice chips and / or chilled water has poor patient adherence due to patient discomfort and side effects including chills, nausea, pain, and teeth hypersensitivity. Additionally, use of ice chips does not uniformly cool the oral mucosa, especially regions under the tongue and where the gingiva meets the interior of the oral cavity.SUMMARY

[0007] The mouth-cooling systems and devices disclosed herein may include a body configured for placement within a user’s oral cavity and an exterior component configured for placement outside the oral cavity so that a surface thereof may contact, or be proximate to, the user’s lips, skin, and / or cheeks. In some examples, the exterior component may be configured to sized and configured to reside outside the user’s mouth when the mouth-cooling device is worn and extend from a left commissure of the user’s lips to a right commissure of the user’s lips. The body and / or exterior component may include one or more cavities within which a heat-absorbing material may be present and / or sealed therein. The heatabsorbing material and / or the mouth-cooling device as a whole may be configured and / or cooled so that heat absorbs from the user’s oral cavity, mouth, lips, skin, and / or cheeks. Additionally, or alternatively, the mouth-cooling device may be configured to induce vasoconstriction and / or reduce capillary blood flow within theuser’s mouth, lips, and / or cheeks when worn. Additionally, or alternatively, the mouth-cooling device may be configured to reduce a metabolism rate of cells (e.g., oral epithelial stem cells) within the user’s mouth, lips, and / or cheeks when worn. Additionally, or alternatively, the mouth-cooling device may be configured to prevent or mitigate development of oral mucositis for the user as may occur before, during, or after the user receives chemotherapy treatment and / or radiotherapy treatment.

[0008] In some examples, the mouth-cooling device and / or a portion thereof may be malleable and / or configured to deform to be proximate to the user’s mouth, lips, or skin so that it may, for example, conform to user anatomy.

[0009] At times, the mouth-cooling device with the heat-absorbing material positioned within cavities thereof may be cooled by, for example, storage in a refrigeration device and / or exposure to a cooling / heat-absorbing substance like dry ice. Additionally, or alternatively, the heat-absorbing material may be cooled and / or refrigerated prior to placement within a cavity of the mouth-cooling device. Prior to insertion within the user’s mouth, the mouth-cooling device may be cooled to a temperature at, or below 37, 20, 18, 15, 13, 10, 8, 6, or 4 degrees Celsius and / or within a range of 4-25 degrees Celsius.

[0010] In some examples, the heat-absorbing material resident within a cavity of the external component may be communicated to a cavity within the body and vice versa. In this way, heat-absorbing material may be exchanged between one cavity and another to, for example, refresh and / or replace heat-absorbing material that may have warmed following use with new, cooled, and / or heatabsorbing material.

[0011] In many instances, the heat-absorbing material may be a phasechange material configured to change phase upon absorption of heat from the user’s mouth and / or may be biocompatible. Exemplary heat-absorbing material may include one or more of saline, water, a hydrogel, encapsulated water particles, encapsulated saline particles, gelatin, a suspension of water and a thickening agent, a combination of water and methylcellulose, and / or an emulsion of water and a thickening agent. Exemplary thickening agents include, but are not limited to a cellulose ether, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and / or xanthan gum.

[0012] The body may comprise an outer reservoir, an inner reservoir, and a connecting portion. The outer reservoir may include an outer reservoir cavity, the outer reservoir may be shaped to extend between a superior oral vestibule cavity of the user and an inferior vestibule cavity of the user when worn with a front side of the outer reservoir that may be configured to be placed proximate to the superior oral vestibule cavity and the inferior oral vestibule cavity, and a back side that may be configured to be proximate to a buccal side of the user’s upper jaw and lower jaw when worn by the user (i.e., positioned within the user’s oral cavity or mouth). The inner reservoir may be shaped to extend between a lingual side of the user’s upper jaw and a lingual side of the user’s lower jaw and abut the user’s tongue when worn and may include an inner reservoir cavity positioned therein. The connecting portion may be configured to connect the inner reservoir and the outer reservoir and fit between the user’s upper jaw and lower jaw (e.g., between the user’s teeth) when worn.

[0013] In some examples, the mouth-cooling devices and systems disclosed herein may include an over-tongue extension with an over-tongue extension cavity positioned therein. The over-tongue extension may extend from an inner side of the inner reservoir and may be sized and configured to reside between the user’s tongue and mouth roof (i.e., on top of the tongue) when worn and the extension cavity may be filled with heat-absorbing material configured to absorb heat from the user’s tongue and mouth roof when the body is positioned within the user’s mouth. Additionally, or alternatively, the mouth-cooling devices and systems disclosed herein may comprise an under-tongue extension with an extension cavity resident therein. The under-tongue extension may extend from an inner side of the inner reservoir and may be sized and configured to reside under the user’s tongue when the body is positioned within the user’s mouth.

[0014] In some examples, the body and / or exterior component may include an opening sized and configured to accept insertion of a plug therein. The plug may act to open, or expose the exterior component cavity, outer reservoir cavity and / or inner reservoir cavity seals so that, for example, heat-absorbing material may be added thereto and / or extracted therefrom and / or sealed within the exterior component cavity, outer reservoir cavity and / or inner reservoir cavity.

[0015] In some examples, the exterior component is configured to extend to, between and / or beyond a left buccal mucosa extension and a right buccal mucosa extension of the user’s mouth when the body is positioned within the user’s mouth. Additionally, or alternatively, the exterior component may be configured to extend to, between, and / or a left commissure of the user’s mouth and a right commissure of the user’s mouth when the body is positioned within the user’s mouth. Additionally, or alternatively, the exterior component may be configured to cool the user’s lips and skin proximate to the user’s lips when the mouth-cooling device is worn. For example, the exterior component may be configured to cool the user’s skin opposing at least one of a superior oral vestibule and an inferior oral vestibule of the user when the mouth-cooling device and / or lips is worn.

[0016] In some examples, the mouth-cooling device may be sized and configured to hold the mouth-cooling device in place within the user’s mouth when the mouth-cooling device is worn. For example, wherein an interior side of the exterior component may include one or more retention features configured to hold the mouth-cooling device in place within the user’s mouth when the mouth-cooling device is worn. Exemplary retention features include, but are not limited to, an extension, a plurality of extensions, a ridge, and a deformable member. In some cases, the retention feature may include a retention feature cavity filled with heatabsorbing material. Additionally, or alternatively, the exterior component may include comprises a handle and a decorative feature extending from and exterior (not user facing) side thereof.

[0017] In some examples, the exterior component may be removably attached to the body. In some of these examples, the body includes a first mating feature and the exterior component includes a second mating feature configured to cooperate with the first mating feature to removably attach the exterior component to the first mating feature.

[0018] The first mating feature may be, for example, a coupling configured to accept insertion of the second mating feature therein. The coupling may be, for example, a threaded coupling configured to accept insertion of the second mating feature therein, the second mating feature may include threads configured to align with corresponding treads of the treaded coupling so that the second mating feature may be screwed into first mating feature, thereby attaching the exteriorcomponent to the body. Additionally, or alternatively, the first mating feature may be configured to snap together with the second mating feature thereby attaching the exterior component to the body. Additionally, or alternatively, the first mating feature may be configured to be held in place relative to the second mating feature via at least one of a sealant, a sleeve, an elastic band, a zip tie, and a gasket.

[0019] In many instances, the mouth-cooling devices and systems disclosed herein are configured to tolerate cleaning and / or sanitation for repeated use. For example, the mouth-cooling devices and systems disclosed herein may be dishwasher safe and / or configured to tolerate sterilization via application of heat, steam, and / or a chemical sterilizing agent.

[0020] In some examples, the mouth-cooling devices and / or systems disclosed herein may include a base configured to fit within a user’s mouth and / or oral cavity. The base may comprise an outer edge configured to be removably coupled to a cooling attachment, an inner reservoir may include an inner reservoir cavity, the inner reservoir may be shaped to extend between a lingual side of the user’s upper jaw and lower jaw and abut the user’s tongue when worn, and a connecting portion configured to connect the inner reservoir and the outer reservoir and fit between the user’s upper jaw and lower jaw when worn. The cooling attachment may be removably coupled to the outer edge of the body; the cooling attachment may include a cooling attachment cavity and may be shaped to extend between a superior oral vestibule cavity of the user and an inferior vestibule cavity of the user when worn with a front side of the outer reservoir may be configured to be placed proximate to the superior oral vestibule cavity and inferior oral vestibule cavity. Heat-absorbing material may be resident within inner reservoir cavity and the cooling attachment cavity, the heat-absorbing material may be configured to absorb heat from inside and outside the user’s mouth when the mouth-cooling device is positioned therein. The cooling attachment may include an opening sized and configured to accept insertion of a plug therein, wherein the plug seals the heat-absorbing material within the cooling attachment cavity and a volume of heatabsorbing material may be removed from and / or added to the cooling attachment cavity via removal of the plug from the opening.

[0021] The mouth-cooling devices and / or systems disclosed herein may be used by placing the body of any of the mouth-cooling devices disclosed hereinwithin the mouth of a user and positioning the exterior portion outside the user’s mouth proximate to the user’s lips so that the body and the exterior portion absorb heat from the user’s mouth, lips, and / or cheeks, reduce capillary blood flow within the user’s mouth, lips, and / or cheeks, induce vasoconstriction within the user’s mouth or lips, reduce a metabolism rate of cells within the user’s mouth, lips, and / or cheeks, or prevent or mitigate development of oral mucositis for the user. In some examples, a temperature of the user’s mouth, mouth-cooling device, and / or portion / component thereof may be measured and / or monitored and, when a temperature the user’s mouth, mouth-cooling device, and / or portion / component thereof rises above a threshold temperature (e.g., 10, 15, or 20 degrees Celsius) a first mouth-cooling device may be removed from the user’s mouth and a second one may be placed therein / thereon.

[0022] In some examples, the mouth-cooling devices disclosed herein the outer reservoir may include a left outer reservoir and a right outer reservoir, and the inner reservoir may include a right inner reservoir and a left inner reservoir. An opening may be formed between the left outer reservoir and the right outer reservoir, wherein the left outer reservoir and the right outer reservoir are laterally flexible relative to one another about the opening. A slit may be formed between the left inner reservoir and the right inner reservoir, wherein the left inner reservoir and the right inner reservoir are laterally flexible relative to one another about the slit.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present disclosure is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[0024] FIG. 1A is a schematic diagram illustrating a top-perspective view of an exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0025] FIG. 1 B is a schematic diagram illustrating a cross-section view of a portion of the mouth-cooling device of FIG. 1 A, in accordance with some examples of the present disclosure;

[0026] FIG. 2A is a schematic diagram illustrating a top view of another exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0027] FIG. 2B is a schematic diagram illustrating a cross-section view of the mouth-cooling device of FIG. 2A, in accordance with some examples of the present disclosure;

[0028] FIG. 2C is a schematic diagram illustrating a perspective view of the mouth-cooling device of FIG. 2A, in accordance with some examples of the present disclosure;

[0029] FIG. 2D is a schematic diagram illustrating a mid-sagittal crosssection view a user with the mouth-cooling device of FIG. 2A correctly positioned (i.e., being worn) in his anatomy (e.g., mouth, lips, cheeks, etc.), in accordance with some examples of the present disclosure;

[0030] FIG. 3 is a schematic diagram illustrating a perspective view of another exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0031] FIG. 4A is a schematic diagram illustrating a perspective view of an exemplary mouth-cooling device with a handle and / or reservoir extending from an exterior surface thereof, in accordance with some examples of the present disclosure;

[0032] FIG. 4B is a schematic diagram illustrating a sectioned, or cut-away, view of the exemplary mouth-cooling device of FIG. 4A with a handle and / or reservoir, in accordance with some examples of the present disclosure;

[0033] FIG. 4C is a schematic diagram illustrating a mid-sagittal crosssection view a user with the mouth-cooling device of FIG. 4A correctly positioned (i.e., being worn) within his anatomy (e.g., mouth, lips, cheeks, etc.), in accordance with some examples of the present disclosure;

[0034] FIG. 5A is a schematic diagram illustrating a perspective view of another exemplary mouth-cooling device when in an open, or unfolded, configuration, in accordance with some examples of the present disclosure;

[0035] FIG. 5B is a schematic diagram illustrating the mouth-cooling device of FIG. 5A when in a closed, or folded configuration, in accordance with some examples of the present disclosure;

[0036] FIG. 5C is a schematic diagram illustrating a cross-section view a user with the mouth-cooling device of FIG. 5A inserted into his mouth when arranged in a folded configuration as shown in FIG. 5B, in accordance with some examples of the present disclosure;

[0037] FIG. 6 is a schematic diagram illustrating an exemplary system that includes a mouth-cooling device in communication with a peristaltic pump, in accordance with some examples of the present disclosure;

[0038] FIG. 7 is a block diagram of a kit including a plurality of mouth-cooling devices and thermally insulating packaging, in accordance with some examples of the present disclosure ;

[0039] FIG. 8A is a schematic diagram illustrating a top view of another exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0040] FIG. 8B is a schematic diagram illustrating a back perspective view of the mouth-cooling device of FIG. 8A, in accordance with some examples of the present disclosure;

[0041] FIG. 8C is a schematic diagram illustrating a side perspective view of the mouth-cooling device of FIG. 8A, in accordance with some examples of the present disclosure;

[0042] FIG. 8C is a schematic diagram illustrating a cross-section view of the mouth-cooling device of FIG. 8A, in accordance with some examples of the present disclosure;

[0043] FIG. 9A is a schematic diagram illustrating a top view of a base for a mouth-cooling device, in accordance with some examples of the present disclosure;

[0044] FIG. 9B is a schematic diagram illustrating a side view of the base of FIG. 9A, in accordance with some examples of the present disclosure;

[0045] FIG. 9C is a schematic diagram illustrating a top view of a cooling attachment, in accordance with some examples of the present disclosure;

[0046] FIG. 9D is a schematic diagram illustrating a perspective view of the cooling attachment of FIG. 9C, in accordance with some examples of the present disclosure;

[0047] FIG. 9E is a schematic diagram illustrating a cross-section view of the cooling attachment of FIG. 9C, in accordance with some examples of the present disclosure;

[0048] FIG. 9F is a schematic diagram illustrating an assembly of the base of FIG. 9A and the cooling attachment of FIG. 9C, in accordance with some examples of the present disclosure;

[0049] FIG. 9G is a schematic diagram illustrating a rear-perspective of the assembly of FIG. 9F, in accordance with some examples of the present disclosure;

[0050] FIG. 9H is a schematic diagram illustrating a cross-section view of the assembly of FIG. 9F, in accordance with some examples of the present disclosure;

[0051] FIG. 10A is a schematic diagram illustrating a top view of an exemplary mouth-cooling device body, in accordance with some examples of the present disclosure;

[0052] FIG. 10B is a schematic diagram illustrating a perspective view of the mouth-cooling device body of FIG. 10A, in accordance with some examples of the present disclosure;

[0053] FIG. 10C is a schematic diagram illustrating a front view of the mouthcooling device body of FIG. 10A, in accordance with some examples of the present disclosure;

[0054] FIG. 10D is a schematic diagram illustrating a cross-section view of the mouth-cooling device body of FIG. 10A, in accordance with some examples of the present disclosure;

[0055] FIG. 11 A is a schematic diagram illustrating a front view of an exemplary fixed-shape exterior component and / or an exemplary deformable exterior component, in accordance with some examples of the present disclosure ;

[0056] FIG. 11 B is a schematic diagram illustrating a top view of the fixed- shape exterior component and / or deformable exterior component of FIG. 11 A, in accordance with some examples of the present disclosure;

[0057] FIG. 11 C is a schematic diagram illustrating a side view of the fixed- shape exterior component and / or deformable exterior component of FIG. 11 A, in accordance with some examples of the present disclosure;

[0058] FIG. 11 D is a schematic diagram illustrating a rear perspective view of fixed-shape exterior component and / or deformable exterior component, in accordance with some examples of the present disclosure;

[0059] FIG. 11 E is a schematic diagram illustrating a cross-section view of fixed-shape exterior component, in accordance with some examples of the present disclosure ;

[0060] FIG. 11 F is a schematic diagram illustrating a side view of a deformable exterior component, in accordance with some examples of the present disclosure;

[0061] FIG. 11 G is a schematic diagram illustrating a cross-section view of the deformable exterior component of FIG. 11 F, in accordance with some examples of the present disclosure;

[0062] FIG. 12A is a schematic diagram illustrating an exploded view of an exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0063] FIG. 12B is a schematic diagram illustrating an exploded view of another mouth-cooling device, in accordance with some examples of the present disclosure;

[0064] FIG. 12C is a schematic diagram illustrating an exploded view of another mouth-cooling device, in accordance with some examples of the present disclosure;

[0065] FIG. 12D is a schematic diagram illustrating an exploded view of another mouth-cooling device, in accordance with some examples of the present disclosure;

[0066] FIG. 13A is a schematic diagram illustrating a top view of a body for a mouth-cooling device, in accordance with some examples of the present disclosure;

[0067] FIG. 13B is a schematic diagram illustrating a front view of the body of FIG. 13A, in accordance with some examples of the present disclosure;

[0068] FIG. 13C is a schematic diagram illustrating a cross-section view of the body of FIG. 13A, in accordance with some examples of the present disclosure;

[0069] FIG. 14A is a schematic diagram illustrating a top view a mouthcooling device that includes the body of FIG. 13A and the fixed deformable exteriorcomponent and / or deformable exterior component of FIGS. 11 A-11 G, in accordance with some examples of the present disclosure;

[0070] FIG. 14B is a schematic diagram illustrating a perspective view of the mouth-cooling device of FIG. 14A, in accordance with some examples of the present disclosure;

[0071] FIG. 14C provides a top view of assembly mouth-cooling device of FIG. 14A with an arrangement of reference lines superimposed thereon, in accordance with some examples of the present disclosure;

[0072] FIG. 14D provides a cross-section view of the mouth-cooling device of FIG. 14A with a fixed-shape external component, in accordance with some examples of the present disclosure;

[0073] FIG. 14E provides a cross-section view of the mouth-cooling device of FIG. 14A with a deformable-shape external component, in accordance with some examples of the present disclosure;

[0074] FIG. 15A is a schematic diagram illustrating a mid-sagittal crosssection view a user with the mouth-cooling device of 14A correctly positioned (i.e., being worn) in his anatomy (e.g., mouth, lips, cheeks, etc.), in accordance with some examples of the present disclosure;

[0075] FIG. 15B is a schematic diagram illustrating a front view the user wearing the mouth-cooling device of 14A, in accordance with some examples of the present disclosure;

[0076] FIG. 15C is a schematic diagram illustrating a bottom perspective view the user wearing the mouth-cooling device of 14A, in accordance with some examples of the present disclosure;

[0077] FIGS. 16A-16E are schematic diagrams of an exemplary mouthcooling device, in accordance with some examples of the present disclosure;

[0078] FIGS. 17A and 17B are schematic diagrams of another exemplary mouth-cooling device, in accordance with some examples of the present disclosure;

[0079] FIG. 18A and 18B are schematic diagrams of a cross-section view of another exemplary mouth-cooling device, in accordance with some examples of the present disclosure; and

[0080] FIGS. 19A-19E are schematic diagrams of another exemplary mouthcooling device, in accordance with some examples of the present disclosure.

[0081] FIG. 19F is a schematic diagram of a cross-section view of a portion of the mouth-cooling device of 19A-19E, in accordance with some examples of the present disclosure.

[0082] FIG. 19G is a top perspective view of a configuration of the mouthcooling device of 19A-19E, in accordance with some examples of the present disclosure.

[0083] FIG. 19H is a mid-sagittal cross-section view of a user with his / her / their tongue positioned within a vestibule of the of the mouth-cooling device of 19A-19E, in accordance with some examples of the present disclosure.

[0084] FIG. 191 is a mid-sagittal cross-section view of the user of FIG. 19H moving his / her / their tongue within vestibule of the of the mouth-cooling device of 19A-19E, in accordance with some examples of the present disclosure.

[0085] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated examples. Moreover, while the following disclosure will now be described in detail with reference to the drawings, the description is done in connection with the illustrative examples. It is intended that changes and modifications can be made to the described examples without departing from the true scope and spirit of the present disclosure as defined by the appended claims.DETAILED DESCRIPTION

[0086] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0087] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of thesesmaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0088] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0089] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0090] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0091] The term “substantially” is used throughout this document to indicate variations in the thus qualified terms. These variations are variations that do not materially affect the manner in which the invention works and can be due, for example, to uncertainty in manufacturing processes or to small deviations from a nominal value or ideal shape that do not cause significant changes to the invention.

[0092] Oral cryotherapy is a mechanism for promoting vasoconstriction and / or reducing cellular metabolism within the mouth, which leads to decreased delivery of OM-causing chemotherapy drugs to the oral tissue and mucosa before, during, and / or after a user receives chemotherapy drugs and / or radiotherapy. Inparticular, cooling oral epithelial stem cells may slow down their growth rates so that, for example off-target effects of chemotherapy agents on the oral epithelial stem cells that may contribute to the development and / or severity of OM may be avoided. Additionally, or alternatively, coo ling -mediated vasoconstriction of the blood vessels of the oral tissue may reduce the blood flow to the oral tissue, which reduces delivery of chemotherapy agents to the mouth during treatment and, consequently, may reduce damage caused to the oral tissue caused by the chemotherapy agents.

[0093] In some examples, the mouth-cooling devices disclosed herein may be configured to cool a user’s mouth and / or a portion thereof below 20 degrees Celsius and / or within a range of 4-25 degrees Celsius (e.g., 4°C to 10°C, or 10°C to 15°C, or 15°C to 20°C, or 10°C to 25°C), encompassing any value and subset therebetween. In some examples, the mouth-cooling devices disclosed herein may be configured to preferentially cool regions of the mouth and / or oral tissue that may be at highest at risk for developing OM, such as an interior surface of the user’s cheeks and / or lips, oral vestibules (crevices between the gums and lips) within the user’s mouth, the user’s soft palate mucosa, floor of the mouth, and / or the user’s tongue (e.g., the ventral surface of the tongue), which may be collectively referred to herein as a “mouth.”

[0094] The mouth-cooling devices disclosed herein may be sized, shaped, and / or configured to fit within and / or conform to a user’s mouth and cool one or more regions of the mouth to, for example, reduce cellular metabolism and / or promote vasoconstriction within the mouth at times from two sides (e.g., inside and outside the mouth).

[0095] In some examples, the mouth-cooling devices disclosed herein may be configured to cool a user’s mouth, or a region thereof, for a pre-set duration of time that may correspond to, for example, a length of time the user receives a chemotherapy infusion (e.g., 15-60 minutes, encompassing any value and subset therebetween) and / or a period of time sufficient to slow cellular metabolism and / or induce vasoconstriction prior to, during, and / or after, for example, infusion with a chemotherapeutic agent and / or exposure to radiation. In some cases, a user may use a plurality of mouth-cooling devices in, for example, a sequential fashion to, for example, provide varying levels of cryotherapy to the mouth as, for example, aplurality (e.g., 2-5, encompassing any value and subset therebetween) of mouthcooling devices that provide progressively stronger cryotherapy to gradually and / or sequentially reduce a temperature of the user’s mouth from, for example, 37 to 25, 20, 15, 10, 5, or 4 degrees Celsius, encompassing any value and subset therebetween. Additionally, or alternatively, in some examples, a mouth-cooling device may be configured to provide consistent cryotherapy for a period of time (e.g., 10-20 minutes, encompassing any value and subset therebetween) and multiple mouth-cooling devices may be used sequentially to cool a user’s mouth should a time period for cooling in excess of the period of time for which a single mouth-cooling device may provide the cryotherapy that is desired and / or needed. For example, if 45 minutes of cryotherapy is recommended for a user, three mouthcooling devices configured to provide cryotherapy may be sequentially used at 15 minute intervals to provide a total of 45 minutes of cryotherapy across the three mouth-cooling devices.

[0096] The mouth-cooling devices disclosed herein may comprise a body that comprises and / or houses a material capable of interfacing and / or thermally communicating with a user’s mouth tissue (e.g., mucosa, lips, tongue, gingiva, etc.) to absorb heat therefrom. The body may be sized, shaped, and / or configured to be comfortably worn and / or prevent application of excessive friction and / or pressure to the user’s mouth or a portion thereof. The body may be made from a soft, or deformable, non-toxic, material such as a food-grade polymer, food-grade silicone, a biocompatible elastomer, and / or a soft edible material (e.g., seaweed) that is selected and / or configured so that it does not significantly (e.g., remains functional) dissolve during use. The mouth-cooling device bodies described herein may be made via any manufacturing process such as 3D printing, injection molding, and / or cast molding.

[0097] In some cases, the mouth-cooling device bodies disclosed herein may be hollow, or partially hollow, and a volume of heat-absorbing material configured may be positioned within hollow openings, or cavities, so that it may extract heat from proximate mouth tissue. The heat-absorbing material may, or may not, be a phase change material and, in many cases, is non-toxic and / or biocompatible. Exemplary heat-absorbing materials include, but are not limited to, water, saline solution, encapsulated water particles, encapsulated saline particles, gelatin, asuspension, a hydrogel, and / or a thickened solution (e.g., a combination of water and a thickener such as a cellulose ester, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and / or xanthan gum)). Additionally, or alternatively, the heat-absorbing material may be in gas and / or vapor form embodied as, for example, a vapor containing frozen saline droplets or particles that are steadily released into cavities within the mouth-cooling devices disclosed herein.

[0098] In some examples, the mouth-cooling device bodies disclosed herein may act and / or include as a thermal insulator configured to, for example, slow the heat transfer between heat-absorbing material and oral tissue, maintain thermal stability of the mouth-cooling device (e.g., keep surface temperature of the mouthcooling device even and / or above a temperature threshold that causes pain or discomfort to a user), and / or prevent heat transfer from non-mucosal tissue within the mouth (e.g., teeth) that may be sensitive to cooling. Additionally, or alternatively, in some examples, the mouth-cooling devices disclosed herein may include an insulation layer positioned on an exterior surface, or a portion of an exterior surface thereof. The insulation layer may comprise, for example, a nontoxic and biocompatible material (e.g. silicone, foam, air, polyurethane, etc.).

[0099] In some examples, the mouth-cooling devices disclosed herein may be configured so that they comfortably fit into a user’s mouth with no additional support or force needed to hold the mouth-cooling device in place. Additionally, or alternatively, one or more of the mouth-cooling devices disclosed herein may be configured to be self-contained so that it does not need to be connected to an additional piece of equipment to be functional during use.[000100] In some examples, a user’s mouth may be treated with, for example, an analgesic and / or pain relieving drug (e.g., lidocaine mouthwash) before, during, and / or after use with one or more of the mouth-cooling devices disclosed herein to, for example, reduce the user’s sensitivity to the cryotherapy so that, for example, the user may tolerate the cryotherapy for a prescribed period of time. Additionally, or alternatively, a mouth-cooling device , or a portion thereof, may be coated and / or treated with an analgesic and / or pain relieving drug configured to interact with oral tissue during use of the mouth-cooling device.[000101] In some examples, the mouth-cooling devices disclosed herein may include a temperature sensor (e.g., temperature sensors) and / or temperature indicating feature (e.g., non-toxic thermochromic inks or dyes embedded in the surface of the device that changes color responsively to detected temperature) configured to measure and / or provide an indication of the temperature inside a user’s mouth and / or a region of the mouth (e.g., under the tongue). Temperature measurements and / or indications may be used by clinicians and / or caregivers to, for example, determine when to replace the mouth-cooling device (i.e. , when the mouth-cooling device is no longer cooling to the desired temperature) and / or provide a feedback mechanism by which increase and / or decrease cooling provided by the mouth-cooling device.[000102] In some examples, the mouth-cooling device may comprise a polymer with low softening point that may be moldable when, for example, heated. In these examples, the mouth-cooling device may be provided to a user in a general form (e.g., a curved shape) and upon application of heat to the device (e.g. in the microwave, or in a bath of hot water), it is introduced into the user’s mouth, for example, the user, a clinician, and / or a professional caretaker and molded into a shape that approximates and / or mimics features of the user’s mouth. As the mouthcooling device returns to an unheated temperature, it retains the molded shape and is therefore customized to the user. In these examples, the mouth-cooling device(s) can be provided in a range of general forms that have varying initial general sizes and shapes configured to accommodate insertion into the mouth of different users, including adult and pediatric patients.[000103] Turning now to the figures, FIG. 1 A provides a top-perspective view of an exemplary mouth-cooling device 100 and FIG. 1 B provides a cross-section view of a portion of mouth-cooling device 100 taken along sectioning line 1 B-1 B shown in FIG. 1A. Mouth-cooling device 100 includes a body 101 , that may have one or more characteristics of the mouth-cooling device bodies disclosed herein. Body 101 includes a left buccal mucosa extension 110A, a right buccal mucosa extension 110B, a superior oral vestibule extension 115A, an inferior oral vestibule extension 115B, a left lateral tongue extension 120A, a right lateral tongue extension 120B, and a floor of mouth portion 125. Left and right buccal mucosa extensions 110A and 110B may be sized, positioned, and / or configured to bepositioned on a respective left and right side of a user’s mouth proximate to buccal mucosa (e.g., between the user’s teeth and cheek) during use. Superior oral vestibule 115A may be sized, positioned, and / or configured to be positioned within a superior oral vestibule of a user’s mouth between the gingiva of the user’s superior jaw and superior lip (i.e. , superior lip crevice during use). Inferior oral vestibule 115B may be sized, positioned, and / or configured to be positioned within an inferior oral vestibule of a user’s mouth between the gingiva of the user’s inferior jaw and inferior lip (i.e., inferior lip crevice) during use. Left and right lateral tongue extensions 120A and 120B may be sized, positioned, and / or configured to be positioned on a respective left and right side a user’s tongue during use. Floor of mouth portion 125 may be sized, positioned, and / or configured to be positioned on a floor of a user’s mouth under his or her tongue during use.[000104] In some examples, mouth-cooling device 100 may be hollow (e.g., include one or more cavities) that may be filled with a heat-absorbing material as, for example, described herein and shown in FIG. 1 B, which shows a cross-section of body 101 with a volume of heat-absorbing material 150, such as the heatabsorbing material disclosed herein, positioned therein.[000105] FIGS. 2A-2D are schematic diagrams illustrating various views of an exemplary mouth-cooling device 200, wherein FIG. 2A illustrates a top view; FIG. 2B illustrates a cross-section view; FIG. 20 illustrates a perspective view; and FIG. 2D illustrates a cross-section view a user 25 with mouth-cooling device 200 positioned within his mouth (i.e., a portion of mouth-cooling device 200 is positioned within the user’s oral cavity 222 and a portion of mouth-cooling device 200 is positioned outside oral cavity 222). Mouth-cooling device 200 includes a superior oral vestibule portion 18 sized, positioned, and configured to be positioned proximate to and absorb heat from a user’s superior oral vestibule 210 (i.e., between an interior side of the user’s superior lip 220, superior oral vestibule 210, and superior teeth 230) during use as shown in FIG. 2D; an inferior oral vestibule portion 12 sized, positioned, and configured to be positioned proximate to and absorb heat from a user’s inferior oral vestibule 215 (i.e., between an interior side of the user’s inferior lip 225, inferior oral vestibule 215, and inferior teeth 235) during use as shown in FIG. 2D; an under-tongue extension 22 sized, positioned, and configured to be proximate to and absorb heat from a region in the user’s mouthunder the user’s tongue 205 as shown in FIG. 2D, an over-tongue extension 14 sized, positioned, and configured to be proximate to and absorb heat from an upper side of the user’s tongue 205 during use as shown in FIG. 2D, a left buccal extension 16A sized, positioned, and configured to be positioned proximate to and absorb heat from a left buccal region of the user’s mouth during use as shown in FIG. 2D, a right buccal extension 16B sized, positioned, and configured to be positioned proximate to and absorb heat from a right buccal region of the user’s mouth during use, and an external component 10 sized, positioned, and configured to reside outside the user’s oral cavity and to be positioned proximate to the user’s superior lip 220 and inferior lip 225 and cheeks during use as shown in FIG. 2D and hold mouth-cooling device 200 in place with the user’s mouth when worn. In some examples, external component 10 may be configured to cool the user’s superior lip 220, inferior lip 225, and cheeks, and / or exterior portions of the mouth, which may be helpful in preventing development of OM on the exterior parts of a user’s lips, particularly among pediatric populations, who are particularly susceptible to the development of sores on the outside of their lips. External component 10 may also be configured to cool internal portions of the user’s mouth from the outside in (e.g., superior oral vestibule 210 and inferior oral vestibule 215 are cooled by both outside component 10 and superior oral vestibule portion 18 and inferior oral vestibule portion 12, respectively.[000106] FIG. 3 provides a perspective view of another exemplary mouthcooling device 300 that includes all the components of mouth-cooling device 200 and further includes an opening 30 sized, positioned, and configured to allows the user to breathe through the device while it is in use. Opening 30 may be a passageway through exterior component 10 so that it is open on both sides, thereby allowing the passage of air into, and out of, the user’s mouth / oral cavity. [000107] In some examples, the mouth-cooling devices disclosed herein may include an external extension that may be configured to be, for example, a reservoir of heat-absorbing material, a handle, and / or one or more decorative accents. FIG. 4A provides a top-perspective view of an exemplary mouth-cooling device with an external extension 400, FIG. 4B provides a side view of mouth-cooling device with external extension 400, and FIG. 4C is a sagittal cross-section view of a user with mouth-cooling device with external extension 400 positioned within his oral cavity.Mouth-cooling device with external extension 400 includes under-tongue extension 22, over-tongue extension 14, left buccal extension 16A, right buccal extension 16B, external component 10, superior oral vestibule portion 18, inferior oral vestibule portion 12, and an external extension 20. Mouth-cooling device with external extension 400 may be positioned within a user’s 25 mouth in a manner substantially the same as the positioning of mouth-cooling device 200 within user’s 25 mouth as shown in FIG. 2D. External extension 20 may be configured to be a handle that facilitates positioning of mouth-cooling device with external extension 400 within a user’s mouth and / or keeping mouth-cooling device with external extension 400 in place within the user’s mouth. Additionally, or alternatively, external extension 20 may be configured as a reservoir for storing heatabsorbing material. Additionally, or alternatively, external extension 20 may be configured to have a decorative feature (in this case, a teddy bear face (as shown in FIGS. 4A and 4B). Alternatively, external extension may have a round shape like external extension 20 shown in FIG. 4C. In some examples, external extension 20 may be removable and / or exchangeable so that, for example, a plurality of external extensions 20 may be used with a single mouth-cooling device during, for example, a treatment session and / or to personalize the mouth-cooling device according to, for example, a user preference. For example, during a thirty minute treatment session, three external extensions 20 may be sequentially used (e.g., one external extension 20 every 10 minutes) so that the cooling is maintained throughout the treatment session.[000108] In some examples, external extension 20 and / or external component 10 may include a valve (e.g., duckbill valve, flip valve, etc.) configured to open in response to force (e.g., pressing or squeezing) exerted thereon so that, for example, heat-absorbent material may be exchanged between external extension 20 and external component 10 and / or other reservoirs of the mouth-cooling device to, for example, exchange warmed heat-absorbent material from external component 10 with cooler heat-absorbent material stored in external extension 20. This may be done via, for example, serial or sequential exchanging of one or more external extensions 20 while the mouth-cooling device is positioned in the user’s mouth.[000109] FIGS. 5A-5C show an example of an elliptically-shaped mouth-cooling device 500 that includes a body 501 that holds a volume of heat-absorbing material therein. In particular, FIG. 5A is a top view of elliptically-shaped mouth-cooling device 500 when in an unfolded state; FIG. 5B is a side view of elliptically-shaped mouth-cooling device 500 when in a folded state; and FIG. 50 is a sagittal crosssection view of user 25 with folded elliptically-shaped mouth-cooling device 500 positioned within his oral cavity 522. Elliptically-shaped mouth-cooling device 500 includes a left buccal mucosa extension 510A, a right buccal mucosa extension 510B, a superior oral vestibule portion 515A, and an inferior oral vestibule portion 515B. FIG. 5A also includes a bisecting line 511 superimposed thereon that marks an approximate location about which elliptically-shaped mouth-cooling device 500 folds as shown in FIGS. 5B and 5C. As may be seen in FIG. 5C, when elliptically- shaped mouth-cooling device 500 is bent (as shown in FIG. 5B) and positioned within a user’s oral cavity 522 (as shown in FIG. 5C), right buccal mucosa extension 510B may be positioned proximate to the user’s right buccal mucosa (e.g., between the user’s teeth and cheek), superior oral vestibule portion 515A may be positioned proximate to the user’s superior oral vestibule (e.g., between the user’s superior lip and the gingiva of the superior jaw), and inferior oral vestibule portion 515B may be positioned proximate to the user’s inferior oral vestibule (e.g., between the user’s inferior lip and the gingiva of the inferior jaw).[000110] FIG. 6 provides a schematic diagram of an exemplary system 600 that includes a mouth-cooling device 601 similar mouth-cooling device 100 (FIG. 1 ) with the exception that it configured to couple to a tube 610 via an inlet port 620 and an outlet port 625. Tube 610 is coupled to a peristaltic pump 630, which pumps cooling vapor and / or liquid into mouth-cooling device 601 via inlet port 620 and pulls the cooling vapor / fluid through, and out of, mouth-cooling device 601 via outlet port 625.[000111] In some examples, the mouth-cooling devices disclosed herein may be configured for storage in a cooler and / or refrigerator and, while stored there, the heat-absorbing material and / or mouth-cooling device may achieve and / or be maintained at a desired temperature (e.g., 4-25 degrees Celsius, encompassing any value and subset therebetween). In these examples, one or more mouthcooling devices may be provided in packaging (e.g., a sealed bag, box, and / or kit)for placement in the cooler and / or refrigerator. Additionally, or alternatively, a plurality of mouth-cooling devices may be packaged together as a kit 700, an example of which is provided by FIG. 7. Kit 700 includes a case 705 with a first, second, third, and fourth mouth-cooling device storage container, or recess, 710A, 710B, 710C, and 710D positioned therein. The first, second, third, and / or fourth recesses 710A, 710B, 710C, and / or 710D may be sized and configured to house one or more mouth-cooling devices like the mouth-cooling devices disclosed herein. In some examples, all of the mouth-cooling devices housed in case 705 may be of the same size and / or configuration and, in other examples, the mouthcooling devices housed in case 705 may be of differing sizes and / or configurations. Case 705 may be made from a thermally insulating material (e.g., Styrofoam, plastic, and / or metal) so that it may prevent a heat exchange between the mouthcooling devices (which may be pre-cooled) and an ambient environment.[000112] In some examples, kit 700 may also include a refrigeration device 720 configured to cool the mouth-cooling devices to a desired temperature. In these examples, kit may further include a power source 730 and / or a temperature sensor (e.g., thermocouple and / or thermometer) 725 configured to sense a temperature within kit 700 and / or activate refrigeration device 720 responsively to a determination that the temperature is above a desired temperature. At times, kit 700 may further include a sanitizing kit 735 which may include, for example, sanitizing solution, a sanitization pouch configured for cooperation with an autoclave, and / or sanitizing wipes.[000113] FIGS. 8A-8D are schematic diagrams that illustrate various views of another exemplary mouth-cooling device 800, wherein FIG. 8A provides a top view, FIG. 8B provides a back-perspective view, FIG. 8C provides a side-perspective view, and FIG. 8C provides a cross-section view of mouth-cooling device 800. Mouth-cooling device 800 includes an outer reservoir 810 including an outer reservoir cavity 815 (see FIG. 8D), an inner reservoir 820 with an optional inner reservoir cavity 825, a connecting portion 830, an optional opening 835, and an optional plug 840. Outer reservoir 810 may be shaped to extend between a superior oral vestibule cavity of the user and an inferior vestibule cavity of the user when worn with a front side of the outer reservoir being configured to be placed proximate to the superior oral vestibule cavity and inferior oral vestibule cavity anda back side being configured to be proximate to a buccal side of the user’s upper jaw and lower jaw when worn by the user as shown in, for example, FIG. 8E.[000114] Inner reservoir 820 may be shaped and / or configured to extend between a lingual side of the user’s upper jaw and lower jaw and abut the user’s tongue when worn by the user as shown in, for example, FIG. 8E. Connecting portion 830 may be shaped and configured to connect the inner reservoir and the outer reservoir and fit between the user’s upper jaw and lower jaw when worn. When the user has teeth, connecting portion 830 may be positioned between the user’s superior teeth 230 and inferior teeth 235 as shown in, for example, FIG. 8E. In some examples, connecting portion 830 may be solid (i.e. , not include a cavity) so that it does not cool the teeth positioned proximate thereto.[000115] Mouth-cooling device 800 may further include a heat-absorbing material positioned within outer reservoir cavity 815 and / or optional inner reservoir cavity 825 and the heat-absorbing material may be configured to absorb heat from inside and outside the user’s mouth, lips, and / or cheeks when mouthcooling device 800 is positioned within the user’s mouth as shown in, for example, FIG. 8E. Mouth-cooling device 800 may further include optional opening 835 sized and configured to accept insertion of optional plug 840 therein. Plug 840 may be sized and configured to fit within opening 835 and form a water-tight seal (via, for example, friction and / or mechanical sealing), thereby sealing the heat-absorbing material within at least one of the outer reservoir cavity and the inner reservoir cavity. In some examples, heat-absorbing material may be removed from and / or added to mouth-cooling device 800 via removal of plug 840 from opening 835 in order to, for example, remove heat-absorbing material that has absorbed heat from the user’s mouth and replace the warmed heat-absorbing material with cool, fresh, heat-absorbing material.[000116] FIGS. 9A-9H provide various views an assembled mouth-cooling device 901 and components thereof. In particular, FIGS. 9A and 9B are schematic diagrams illustrating top and side views, respectively, of a base 900; FIGS. 9C-9E are schematic diagrams illustrating top, perspective, and cross-section views, respectively, of a cooling attachment 950, and FIGS. 9F, 9G, and 9H are top, rearperspective, and cross-section views, respectively, of an assembly 901 of base 900 and cooling attachment 950. Base 900 includes an outer portion 910, an innerreservoir 920 (which may include an optional inner reservoir cavity like inner reservoir cavity 925 (FIG. 9B)), and connecting portion 930. An exterior edge of outer portion 910 includes one or more attachment mechanisms configured to attach to cooling attachment 950 as shown in the cross-section view of FIG. 9H. As may be seen in FIG. 9H, cooling attachment 950 may fit into a corresponding notch or indentation in an exterior edge of base 900; the indentation being sized and configured to removably accept insertion of cooling attachment 950 and be held in place therein via, for example, friction and / or bonding (e.g., glue, sealant, etc.). [000117] Cooling attachment 950 is sized and shaped to cooperate with an outer edge of body 900 (e.g., exterior edge of outer portion 910) and attach thereto as shown in, for example, FIGS. 9F-9H. Cooling attachment 950 is shaped to extend between a superior oral vestibule cavity of the user and an inferior vestibule cavity of the user when worn with a front side of the outer reservoir being configured to be placed proximate to the superior oral vestibule cavity and inferior oral vestibule of the user in a manner similar to that shown in FIG. 8E. Cooling attachment 950 includes a cooling attachment cavity 960 shaped and configured for acceptance of heat-absorbing material therein via, for example, removal of a plug 955 from a corresponding opening in cooling attachment 950.[000118] In some examples, assembly 901 may be worn by a user to cool the user’s mouth and, when the heat-absorbing material is no longer sufficiently cooling the mouth (e.g., has reached a temperature above 20 or 25 degrees Celsius), assembly 901 may be removed from the user’s mouth, a first cooling attachment 950 may be removed from body 900 and a second, fresh, and cooled (e.g., between 5-20 degrees Celsius, encompassing any value and subset therebetween) cooling attachment 950 may be attached to body 900 and the new assembly 901 may be inserted into the user’s mouth for continued cooling thereof.[000119] FIGS. 10A-10D are schematic diagrams that illustrate various views of another exemplary mouth-cooling device body 1000, wherein FIG. 10A provides a top view, FIG. 10B provides perspective view, FIG. 10C provides a front view, and FIG. 10D provides a cross-section view thereof. Mouth-cooling device 1000 is similar to mouth-cooling device 800 because it includes outer reservoir 810, which includes outer reservoir cavity 815, inner reservoir 820, which includes optional inner reservoir cavity 825, connecting portion 830, optional opening 835 (see FIG.8D), and optional plug 840. In addition to these components, mouth-cooling device body 100 further includes an attachment coupling 1015 configured for attachment to an external component like external component 1100A and / or 1100B shown in FIGS. 11A-11 D.[000120] FIGS. 11 A-11 G are schematic diagrams that illustrate various views of an exemplary fixed-shape exterior component 1100A and / or an exemplary deformable exterior component 1100B, wherein FIG. 11A is a front view, FIG. 11 B is a top view, FIG. 11 C is a side view, FIG. 11 D is a rear-perspective view of fixed- shape exterior component 1100A and / or deformable exterior component 1100B; FIG. 11 E is a cross-section view of fixed-shape exterior component 1100A; FIG.11 F is a side view of deformable exterior component 1100B; and FIG. 11 G is a cross-section view of deformable exterior component 1100B. An upper (as oriented in FIG. 11A) edge of fixed-shape exterior component 1100A and / or deformable- shape exterior component 1100B may include an optional notch 1130 present in an approximate middle of the upper edge. Notch 1130 may be configured to allow for external component to extend between the user’s lips and nose but not touch or overly the user’s nose as shown in, for example, 15A-15C.[000121] Fixed-shape exterior component 1100A includes a fixed-shape body 1110A from which an attachment extension 1120 extends as shown in FIGS. 11 C- 11 E. Fixed-shape body 1110A also includes a cavity 1115 (as shown in the crosssection of FIG. 11 E) within which heat-absorbing material may be resident.Extension 1120 may include a central lumen, or channel, 1135 through which heatabsorbing media may be put into and / or extracted from cavity 1115 when, for example, adding cooled heat-absorbing material to cavity 1115 and / or transferring heat-absorbing media to and / or from a cavity in a corresponding mouth-cooling device body as shown in, for example, FIGS. 13A-13F and discussed below.Extension 1120 may further include an upper (as oriented in FIG. 11 E) and a lower tab 1125 configured to engage with a corresponding opening of a mouth-cooling device body, thereby holding fixed-shape exterior component 1100A and the mouth-cooling device body together as shown in, for example, FIGS. 13A-13F and discussed below.[000122] Fixed-shape body 1110A may be shaped and configured so that it resides outside the user’s mouth when a mouth-cooling device is worn and iscurved to extend from approximately a left commissure of the user’s lips to a right commissure of the user’s lips and / or extend between the user’s left and right buccal mucosa extensions when a mouth-cooling device is worn. An interior arc of curvature for body 1110A / B may be curved at a rate of 5mm per 30mm of length so that an apex on the interior arc is 25mm away from a lowest point of the arc as shown in the example of FIG. 11 B. Approximate dimensions for body 1110A / B range between 40-80mm high, 80-175mm wide, and 12-30mm thick, encompassing any value and subset therebetween, with the dimensions of one example of mouthcooling device body 1110 being 65mm high by 125mm wide by 20mm thick.[000123] Deformable exterior component 1100B is substantially similar to fixed- shape exterior component 1100A with the exception that it includes a deformable element 1140 configured and positioned within deformable body 1110B so that it may be deformed and hold a deformed shape, which thereby allows deformable body 1110 to be bent, or deformed, to for example, conform to anatomical features of a user’s face. Deformable element 1140 may be, for example, a wire, a shapememory wire, a compressible foam, or any other component configured to deform and hold its deformed shape.[000124] FIGS. 12A-12D provide schematic diagrams of exploded views of four different mouth-cooling devices that include a mouth-cooling device body 1000 and four different examples of external component 1100A and 1100B, wherein FIG. 12A provides an exploded view of a first mouth-cooling device 1200A that includes a first mouth-cooling body 1000A with a first attachment coupling 1015A comprising a series of threads sized, shaped, and configured to cooperate with and engage corresponding threads on a first attachment extension 1120A that extends from a first fixed-shape body 1110A1 and / or a first deformable body 1110B1 of a first fixed-shape external component 1100A1 and / or a first deformable external component 1100B1 as shown. First mouth-cooling device body 1000A and first fixed-shape external component 1100A1 and / or a first deformable external component 1100B1 may be assembled together by aligning first attachment extension 1120A with first attachment coupling 1015A and twisting first attachment extension 1120A relative to first attachment coupling 1015A in a screw-like manner so that first fixed-shape body 1110A1 and / or a first deformable body 1110B1 is removably attached to first mouth-cooling device body 1000A.[000125] FIG. 12B provides an exploded view of a second mouth-cooling device 1200B that includes a second mouth-cooling body 1000B with a second attachment coupling 1015B that includes a plurality of cantilever and / or u-shaped snap fit joints sized, shaped, and configured to cooperate with and engage with a corresponding mechanism (e.g., a snap-fit joint) of a second attachment extension 1120B of a second fixed-shape body 1110A2 and / or a second deformable body 1110B2 of a respective second fixed-shape external component 1100A2 and / or second deformable external component 1100B2 as shown. Second mouth-cooling device body 1000B and second fixed-shape body 1110A2 and / or a second deformable body 1110B2 may be assembled together by aligning second attachment extension 1120B with second attachment coupling 1015B and pressing them together so that second fixed-shape body 1110A2 and / or a second deformable body 1110B is removably attached to second mouth-cooling device body 1000B, thereby assembling second mouth-cooling device 1200B.[000126] FIG. 12C provides an exploded view of a third mouth-cooling device 1200C that includes a third mouth-cooling body 1000C with a third attachment coupling 1015C and a third fixed-shape body 1110A3 and / or a third deformable body 1110B3. Third mouth-cooling body 1000C includes a third attachment coupling 1015C with an opening therein sized, shaped, and configured to cooperate with and engage with a corresponding mechanism of a third attachment extension 1120C of a third fixed-shape body 1110A3 and / or a third deformable body 1110B3 as shown. Third mouth-cooling device body 1000C and third fixed- shape external component 1100A3 and / or third deformable external component 1100B3 may be assembled together by aligning third attachment extension 1120C with third attachment coupling 1015C and pressing them together so that third external component 1100C is removably attached to third mouth-cooling device body 1000C. One or more retention mechanisms 1210 that extend between third mouth-cooling device body 1000C and third fixed-shape body 1110A3 and / or a third deformable body 1110B3 may then be put in place as shown to secure assembly of third mouth-cooling device 1204.[000127] FIG. 12D provides an exploded view of a fourth mouth-cooling device 1200D that includes a fourth mouth-cooling body 1000D with a fourth attachment coupling 1015D with an opening therein sized, shaped, and configured tocooperate with and engage with a corresponding mechanism of a fourth attachment extension 1120D of a fourth fixed-shape body 1110A4 and / or a fourth deformable body 1110B4. Fourth mouth-cooling device body 1000D and fourth fixed-shape body 1110A4 and / or a fourth deformable body 1110B4 may be assembled together by aligning fourth attachment extension 1120D with fourth attachment coupling W15D and pressing them together so that fourth fixed-shape body 11 A4 and / or a fourth deformable body 11 B4 is removably attached to fourth mouth-cooling device body WOOD. A sleeve 1220 may then be placed over a joint between fourth attachment coupling 1015D and fourth attachment extension 1120D as shown to secure assembly of fourth mouth-cooling device 1204.[000128] In some examples, attachment coupling 1015, attachment extension 1120, and / or external component 1100 may include a valve (e.g., duckbill valve, flip valve, etc.) configured to open in response to force (e.g., pressing or squeezing) exerted thereon so that, for example, heat-absorbent material may be exchanged between external component 1100 and inner reservoir cavity 825 (see FIG. 8D) to, for example, exchange warmed heat-absorbent material from inner reservoir cavity 825 with cooler heat-absorbent material stored in the mouth-cooling device. This may be done via, for example, serial or sequential exchanging of one or more external components 1100 while mouth-cooling device 800 is positioned in the user’s mouth.[000129] Additionally, or alternatively, in some examples, a coupling between attachment extension 1120 and attachment coupling 1015 may be a detent mechanism wherein the attachment extension 1120 clicks or otherwise engages with a corresponding portion of attachment coupling 1015 to adjust a distance between attachment extension 1120 and attachment coupling 1015 to, for example, create a snug fit between attachment extension 1120 and the user’s lips and / or cheeks.[000130] FIGS. 13A-13C provide schematic diagrams illustrating various views of another exemplary mouth-cooling device 1300, wherein FIG. 13A provides a top view, FIG. 13B provides a front view, and FIG. 13C provides a cross-section view of mouth-cooling device 1300. Mouth-cooling device 1300 is similar to mouth-cooling device 800 in that it comprises an outer reservoir 1310 including an outer reservoir cavity 1315 (see in FIG. 130) , an inner reservoir 1320 with an inner reservoir cavity1325 (see FIG. 13C), and a connecting portion 1330. Unlike mouth-cooling device 800, mouth-cooling device 1300 also includes an opening 1350 (see FIG. 13B) into which attachment extension 1120 may be inserted as shown in, for example, FIGS. 14A-14D. Heat-absorbing media may be resident within inner reservoir cavity 1325 and / or outer reservoir cavity 1315.[000131] FIGS. 14A-14E provide schematic diagrams illustrating various views of an assembly 1401 of mouth-cooling device 1300 and fixed-shape body 1110A (FIGS. 14A-14D) and / or an assembly 1402 of mouth-cooling device 1300 and deformable body 1110B (FIGS. 14A, 14B, 14C, and 14E), wherein FIG. 14A provides a top view and FIG. 14B provides a perspective view of assembly 1401 and / or 1402 and FIG. 14C provides a top view of assembly 1401 and / or 1402 with an arrangement of reference lines superimposed thereon, FIG. 14D provides a cross-section view of assembly 1401 , and FIG. 14E provides a cross-section view of assembly 1402.[000132] As may be seen in the cross-section views FIGS. 14D and 14E, when assembled, attachment extension 1120 of fixed-shape body 1110A and / or deformable body 1110B are inserted into opening 1350 (see FIG. 13B) so that upper and lower tabs 1125 are deformed to push through opening 1350 and then return to their original shape once inside outer reservoir 1310, which holds fixed- shape body 1110A or deformable body 1110B in place relative to mouth-cooling device 1300. Cavity 1115 and outer reservoir cavity 1315 may be in fluid communication with one another via channel 1135 whereby heat-absorbing material resident within cavity 1115 may be added to outer reservoir cavity 1315 and / or exchanged with heat-absorbing material resident within outer reservoir cavity 1315.[000133] The gridlines of FIG. 14C provide exemplary dimensions for assembly 1401 and / or 1402 wherein there are four horizontal reference lines: H1 , H2, H3, and H4 and four vertical reference lines: V1 , V2, V3, and V4. Approximate distances between these reference lines are included in Table 1 as follows:Table 1[000134] These distances of Table 1 are exemplary and may be proportionally scaled up or down to make an assembly and / or mouth-cooling device that is sized to fit a particular user. In some instances, they may be scaled and / or proportioned in pre-set sizes such as small, medium, and large; adult, child, and infant; adjusted to account for skin thickness, etc.[000135] FIG. 15A is a schematic diagram illustrating a mid-sagittal crosssection view, FIG. 15B is a front view, and FIG. 15C is a bottom -perspective view of user 25 with the mouth-cooling device of 1401A / B correctly positioned (i.e., being worn) in his anatomy so that it is proximate to user’s 25 mouth and surrounding tissue (e.g., lips, skin, cheeks, etc.). As may be seen in FIG. 15A, a right side of mouth-cooling device 1300 is in position proximate to a right side of user’s 25 tongue and a right side of fixed-shape exterior component 1100A or deformable exterior component 1100B wraps around the user’s 25 face so that it covers the lips and skin covering buccal side of the user’s upper jaw and lower jaw. As may be seen in FIGS. 15B and 15C, fixed-shape exterior component 1100A or deformable exterior component 1100B resides outside the user’s 25 mouth when the mouthcooling device is worn and extends from approximately a left commissure of the user’s lips to approximately a right commissure of the user’s lips.[000136] FIGS. 16A-16E provide various views of another mouth-cooling device 1600, wherein FIG. 16A provides a top view, FIG. 16B provides a front view, FIG. 16C provides a perspective view, FIG. 16D provides a top sectional view, and FIG. 16E provides a bottom sectional view of mouth-cooling device 1600. Mouthcooling device 1600 includes an outer reservoir 1610, an inner reservoir 1620, a connecting portion 1630, and an opening 1625. The horizontal cross-section of FIG. 16D shows a first, or upper, portion 1601 of mouth-cooling device 1600 and the horizontal cross-section of FIG. 16E shows a second, or lower, portion 1602 ofmouth-cooling device 1600. Upper portion 1601 includes an upper left outer reservoir cavity 1615A1 , an upper right outer reservoir cavity 1615B1 , an upper portion of a channel 1627A extending from external opening 1625 to an internal opening, an upper left inner reservoir cavity 1622A1 , and an upper right inner reservoir cavity 1622B1 . When upper portion 1601 is positioned over lower portion 1602, right outer reservoir cavity 1615A1 / A2, left outer reservoir cavity 1615B1 / B2, channel 1627, right inner reservoir cavity 1622A1 / A2, and left inner reservoir cavity 1622B1 / B2 may be formed, or closed. In many cases, a heat-absorbing material may be resident in right outer reservoir cavity 1615A, left outer reservoir cavity 1615B, right inner reservoir cavity 1622A, and left inner reservoir cavity 1622B prior to and / or following joining of upper portion 1601 and lower portion 1602. Channel 1627 may be a passageway through exterior component mouth-cooling device 1600 that is open on both sides, thereby allowing the passage of air into, and out of, the user’s mouth / oral cavity via opening 1625.[000137] FIG. 17A provides a rear perspective view and FIG. 17B provides a rear view of another mouth-cooling device 1700 that includes an over-tongue cooling member 1785 sized, shaped, and configured to fit over a user’s tongue so that it may interface with heat-absorbing material stored therein and be cooled. In addition, mouth cooling device 1700 includes an outer reservoir 1710, an inner reservoir 1720, a connecting portion 1730, and an opening 1725 through which the user may breathe.[000138] FIGS. 18A and 18B are schematic diagrams of a cross section of a system 1801 including another mouth-cooling device 1800 with a heat-absorbing media exchange mechanism and an optional exterior component 1805 with a heatabsorbing media exchange mechanism. Mouth-cooling device 1800 includes an outer reservoir 1810, an inner reservoir 1820, a connecting portion 1830, an outer reservoir cavity 1815, an inner reservoir cavity 1822. Outer reservoir cavity 1815 may be in fluid communication inner reservoir cavity 1822 via a first channel 1835A and an optional second channel 1835B. In some examples, one, or both, ends of first and / or second channels 1835A and / or 1835B may terminate with and / or be covered by a valve, which may be, for example, a duckbill valve, a flip valve, and / or a pinch valve. Fluid may be exchanged between outer reservoir cavity 1815 and inner reservoir cavity 1822 when, for example, a user bites, or presses down oninner reservoir 1820, which may increase the pressure within inner reservoir cavity 1822 and push fluid from inner reservoir cavity 1822 into outer reservoir cavity 1815 when the valve opens via, for example, pressure exerted thereon. When the user stops pressing (e.g., releases his or her bite), a pressure-differential (e.g., vacuum) may be created that pulls liquid out of outer reservoir cavity 1815 into inner reservoir cavity 1822.[000139] Optional, exterior component 1805 may be a reservoir for heatabsorbing media (labeled PCM (for phase change material) in the figure) and may include a coupling 1840 configured to cooperate with mouth-cooling device 1800 to attach exterior component 1805 to mouth-cooling device 1800 as, for example, described herein. In addition, exterior component 1805 and / or coupling 1805 may include a first exterior component to external reservoir cavity channel 1815A and an optional second exterior component to external reservoir cavity channel 1815B. In some examples, one, or both, ends of first and / or second channels 1815A and / or 1815B may terminate with and / or be covered by a valve, which may be, for example, a duckbill valve, a flip valve, and / or a pinch valve. Fluid may be exchanged between outer reservoir cavity 1815 and exterior component 1805 when, for example, a user bites, or presses down on inner reservoir 1820 and / or presses or squeezes exterior component 1805, which may cause fluid exchange between exterior component 1805 and outer reservoir cavity 1815 via first and / or second channels 1815A and / or 1815B and / or their respective valves in a manner that may be similar to that described above with regard to the exchange of fluid between inner reservoir cavity 1822 and outer reservoir cavity 1815. In one exemplary use case, when heat-absorbing media resident within inner and / or outer reservoir cavities 1815 and / or 1822 warms while mouth-cooling device is in the mouth, it may be exchanged with cooler heat-absorbing material stored in exterior component 1805 via channels 1815A, 1815B, 1835A and / or 1835B and their corresponding optional valves. For example, in one example, a series of duckbill valves and channels 1815A, 1815B, 1835A and / or 1835B guide the transfer of cooled, or frozen, heat-absorbent material from external component 1805 to inner and / or outer reservoir cavities 1815 and / or 1822. When, for example, the heatabsorbing material stored in a first external component 1805 warms, it may be removed from mouth-cooling device 1805 and replaced with a second, new andcooled external component 1805. In this way, the heat-absorbing material stored in inner and / or outer reservoir cavities 1815 and / or 1822 may remain cool over time (e.g., 10-50 minutes) without the need to remove mouth-cooling device 1805 from the user’s mouth.[000140] FIGS. 19A-19G provide various views of another mouth-cooling device 1900, wherein FIG. 19A provides a top perspective view, FIG. 19B provides a back perspective view, FIG. 19C provides an upper / lower 1901 / 1902 sectional view, FIG. 19D provides a top view in a first configuration, and FIG. 19E provides a top view in a second configuration of mouth-cooling device 1900. FIG. 19F provides a schematic diagram of a cross-section view of a portion 1903 of mouthcooling device 1900. FIG. 19G provides a top perspective view of a configuration 1904 of mouth-cooling device 1900.[000141] Mouth-cooling device 1900 includes left outer reservoir 1910A, right outer reservoir 1910B, left inner reservoir 1920A, right inner reservoir 1920B, and connecting portion 1930. Mouth-cooling device 1900 may comprise an upper portion 1901 including upper left outer reservoir 1915A1 , upper right outer reservoir 1915B1 , upper left inner reservoir 1922A1 , and upper left reservoir 1922B1 .Similarly, mouth-cooling device 1900 may comprise a lower portion 1902 including lower left outer reservoir 1915A2, lower right outer reservoir 1915B2, lower left inner reservoir 1922A2, and lower right inner reservoir 1922B2. Upper portion 1901 and lower portion 1902 of mouth-cooling device 1900 may be the same or similar, as represented by FIG. 19C. Upper portion 1901 and lower portion 1902 of mouth-cooling device 1900 may snap or otherwise attached mechanically or physically (e.g., adhesively, thermally, with mechanical tabs) form single component mouth-cooling device 1900. In some examples, upper portion 1901 and lower portion 1902 may differ in height or other minor variations, for example, to accommodate a better fit within a user's mouth or accommodate other physical requirements and / or barriers.[000142] When upper portion 1901 and lower portion 1902 form mouth-cooling device 1900, upper left outer reservoir 1915A1 and lower left outer reservoir 1915A2 form left outer reservoir cavity 1915A; upper right outer reservoir 1915B1 and lower right outer reservoir 1915B2 form right outer reservoir cavity 1915B; upper left inner reservoir 1922A1 and lower left inner reservoir 1922A2 form leftinner reservoir cavity 1922A; upper right inner reservoir 1922B1 and lower right inner reservoir 1922B2 form right inner reservoir cavity 1922B. A cooling / heat- absorbing material may be resident in left outer reservoir cavity 1915A, right outer reservoir cavity 1915B, left inner reservoir cavity 1922A, and / or right inner reservoir cavity 1922B prior to and / or after joining upper portion 1901 and lower portion 1902. One or more optional plug seals, such as those described herein, may be used to seal the cooling / heat-absorbing material within cavities 1915A / 1915B / 1922A / 1922B.[000143] As provided below, while mouth-cooling device 1900 is shown as having upper portion 1901 and lower portion 1902, the particular features described herein are equally applicable to a singular bodied mouth-cooling device (i.e. , wherein there is not upper and lower portion, but a single body), without departing from the scope of the present disclosure and will, therefore, be described with reference to the left outer reservoir 1910A, right outer reservoir 1910B, left inner reservoir 1920A, and right inner reservoir 1920B to encompass both examples.[000144] When mouth-cooling device 1900 is worn by a user, left outer reservoir 1910A may be shaped to extend between a left superior oral vestibule cavity of the user and a left inferior vestibule cavity of the user, with a front side of the left outer reservoir 1910A being configured to be placed proximate to the left superior oral vestibule cavity and the left inferior oral vestibule cavity and a back side of the left outer reservoir 1910A being configured to be proximate to a left buccal side of the user’s upper jaw and lower jaw (see, e.g., FIG. 8E). Similarly, when mouth-cooling device 1900 is worn by a user, right outer reservoir 1910B may be shaped to extend between a right superior oral vestibule cavity of the user and a right inferior vestibule cavity of the user, with a front side of the right outer reservoir 1910B being configured to be placed proximate to the right superior oral vestibule cavity and the right inferior oral vestibule cavity and a back side of the right outer reservoir 1910B being configured to be proximate to a right buccal side of the user’s upper jaw and lower jaw (see, e.g., FIG. 8E).[000145] Left outer reservoir 1910A and right outer reservoir 1910B are wholly separated, thereby forming open channel 1935. In one or more examples, left outer reservoir 1910A and right outer reservoir 1910B may be laterally flexible with respect to one another, allowing open channel 1935 to decrease or increase inlongitudinal width when worn by the user. Left outer reservoir 1921 A flexes laterally toward the left side of the mouth-cooling device 1900 and right outer reservoir 191 OB flexes laterally toward the right side of mouth-cooling device 1900. Open channel 1935 may decrease in longitudinal width when left outer reservoir 1910A and right outer reservoir 191 OB flex laterally closer to one another (e.g., if the user has a relatively smaller mouth, such as microstomia) and may increase in longitudinal width when left outer reservoir 1910A and right outer reservoir 191 OB flex laterally farther from one another (e.g., if the user has a relatively larger mouth, such as macrostomia). As such, the mouth-cooling device 1900 may provide universal fit without the need for individual user customization. Accordingly, a portion of the mouth-cooling device 1900 may be flexible, such as at pivotal points 19A / 19B, and may be made of a flexible material (e.g., bendable plastic, elastomer), to permit lateral movement of left outer reservoir 1910A and right outer reservoir 1910B. Moreover, left outer reservoir 1910A and right outer reservoir 1910B may laterally flex independent of one another in some examples.[000146] When mouth-cooling device 1900 is worn by a user, left inner reservoir 1920A and right inner reservoir 1920B may be sized, positioned, and configured to be positioned to receive the tongue 205 of the user within vestibule 1925 as shown in FIG. 19H. In some examples, vestibule 1925 may be configured and / or sized to allow movement (e.g., backward and forward and / or side to side) of tongue 205 therein as shown in FIG. 191. Specifically, left inner reservoir 1920A is shaped to extend between a left lingual side of the user’s upper jaw and a left lingual side of the user’s lower jaw and abut a left side of the user’s tongue 205 within vestibule 1925; whereas right inner reservoir 1920B is shaped to extend between a right lingual side of the user’s upper jaw and a right lingual side of the user’s lower jaw and abut a right side of the user’s tongue 205 within vestibule 1925.[000147] Left inner reservoir 1920A and right inner reservoir 1920B are at least partially separated, thereby forming open slit 1924 (e.g., a relatively long, narrow opening). In one or more examples, left inner reservoir 1920A and right inner reservoir 1920B may be laterally flexible with respect to one another about the slit 1924, allowing vestibule 1925 to decrease or increase in longitudinal width when worn by the user. Left inner reservoir 1920A flexes laterally toward the left side ofthe mouth-cooling device 1900 and right inner reservoir 1920B flexes laterally toward the right side of mouth-cooling device 1900. Vestibule 1925 may decrease in longitudinal width when left inner reservoir 1920A and right inner reservoir 1920B flex laterally closer to one another and may increase in longitudinal width when left inner reservoir 1920A and right inner reservoir 1920B flex laterally farther from one another, thereby accommodating the size of a user's tongue without the need for individual customization. Accordingly, a portion of the mouth-cooling device 1900 may be flexible, such as at pivotal points 19C / 19D, and may be made of a flexible material (e.g., bendable plastic, elastomer), to permit lateral movement of left inner reservoir 1920A and right inner reservoir 1920B. Moreover, left inner reservoir 1920A and right inner reservoir 1920B may laterally flex independent of one another in some examples.[000148] Each of pivot points 19A / B / C / D may be separate or continuous, as shown in FIGS. 19D and 19E.[000149] It is to be appreciated that the flexibility of the left outer reservoir and the right outer reservoir with reference to mouth-cooling device 1900 may be applicable to any single formed mouth-cooling device. That is, there need not be an upper left and right outer component or lower left and right outer component; rather, a single left outer component and a single right outer component may be laterally flexible with respect to one another, without departing from the scope of the present disclosure. Moreover, it is to be appreciated that the flexibility of the left inner reservoir and the right inner reservoir with reference to mouth-cooling device 1900 may be applicable to any single formed mouth-cooling device. That is, there need not be an upper left and right inner component or lower left and right inner component; rather, a single left inner component and a single right inner component may be laterally flexible with respect to one another, without departing from the scope of the present disclosure.[000150] FIG. 19F provides a schematic diagram of a cross-section of another example 1903 of mouth-cooling device 1900 comprising a plurality of dimples (or recesses) 1940, positioned on an interior surface of portions of mouth-cooling device 1900 that may correspond to areas of mouth-cooling device 1900 that may be in contact with and / or proximate to mucosal tissue (e.g., gums, inner cheek, etc.). For example, a portion of an inner surface of mouth-cooling device 1900 mayhave an array of dimples 1940, as shown, that create thinner areas within a matrix of thicker supportive areas. This provides a device and method for adjusting the overall heat transfer coefficient without compromising structural integrity. The dimples 1940 may be, for example, concave cubes and / or concave domes, such as on a golf ball surface and may be arranged in any type of pattern including, but not limited to, a grid or honeycomb pattern. In some examples, an arrangement or pattern of dimples 1940 may change (e.g., increase and / or decrease in density) in various regions of mouth-cooling device 1900 responsively to, for example, regions of user anatomy (e.g., mucosa) to, for example, adjust the relative heat transfer and / or structural stability. In some examples, the dimples 1940 may be placed preferentially along surfaces where heat transfer needs to be greater, such as in warmer areas of the anatomy. It is to be understood that while dimples 1940 are shown along the interior portion of right outer reservoir 1910B, they may be included along one or more of the interior portions of left outer reservoir 1910A, left inner reservoir 1920A, and / or right inner reservoir 1920B, without departing from the scope of the present disclosure. Moreover, dimples 1940 may be included along the interior of any portions of any of the mouth-cooling devices of the present disclosure that, when worn, may be in contact with and / or proximate to mucosal tissue (e.g., gums, inner cheek, etc.), without departing from the scope of the present disclosure.[000151] FIG. 19G provides a top perspective view of a configuration of another example 1904 of mouth-cooling device 1900 comprising a single or a plurality (two shown) of flavor-infused spots 1950 (i.e., chemically flavor-infused spots 150). Flavor-infused spots 1950 may beneficially permit the user to experience a pleasant taste when the mouth-cooling device 1900 is worn. Flavor- infused spots 1950 may, for example, trigger salivation by the user to release a flavor and, further, provide a hydration experience to the user. As shown, flavorinducing spots may be located at a front, external position of left outer reservoir 1910A and right outer reservoir 1910B. Alternatively, or in addition, one or more flavor-inducing spots may be located at a front, external position of left inner reservoir 1920A and / or right inner reservoir 1920B. Moreover, alternatively, or in addition, one or more flavor-inducing spots 150 may be located at a back, external position of left outer reservoir 1910A, right outer reservoir 1910B, left inner reservoir1920A, and / or right inner reservoir 1920B. That is, flavor-inducing spots 150 may be located at any external portion of the mouth-cooling device 1900, without limitation. In some examples, flavor-infused spots 1950 may be interchangeable and / or replaceable when, for example, mouth-cooling device 1900 is configured to be reusable.[000152] Flavor-inducing spots 150 may be any shape, such as circular, square, rectangular, ovular, polygonal (regular or irregular), and non-polygonal. Flavor-inducing spots may be any size, provided that they are commiserate with the size of the applicable portion of the mouth-cooling device 1900 to which they are associated. Moreover, the amount of flavor-inducing spots 150 is non-limiting and may be in the form of an array of flavor-inducing spots 150, and may be arranged in any type of pattern including, but not limited to, a grid or honeycomb pattern. In one or more examples, the plurality of flavor-induced spots 150 may be arranged such that inter-spatial separation does or does not exist between the plurality of flavor-induced spots 150, effectively forming a single flavor-induced spot 150. [000153] In one or more examples, flavor-inducing spots 150 may be selectively adhered and removed from mouth-cooling device 1900 by the user. In such a manner, one or more flavor-inducing sport 150 may be removed upon diminishment of the chemically infused flavor and replaced. Alternatively, or in addition, one or more flavor-infused spots 150 may be impregnated within the material forming mouth-cooling device 1900.[000154] It is to be understood that flavor-inducing spots 150 may be included along the exterior of any portions of any of the mouth-cooling devices of the present disclosure that, when worn, may be in contact with and / or proximate to mucosal tissue (e.g., gums, inner cheek, etc.), without departing from the scope of the present disclosure.[000155] In some examples, a size and / or shape of the mouth-cooling device bodies disclosed herein may be adjustable via, for example, one or more an inflatable balloons and / or bladders that may be inflated using, for example, air, water, and / or saline to, for example, thermally insulate a portion of the mouth, occupy empty space within the mouth, restrict movement of the tongue, and / or press a mouth-cooling device body and / or a portion thereof against oral tissue.[000156] In some examples, the mouth-cooling devices disclosed herein may include a temperature sensor (e.g., a thermometer) and / or temperature indicating device (e.g., color coded device that changes color responsively to detected temperature) configured to measure and / or provide an indication of the temperature inside a user’s mouth and / or a region of the mouth (e.g., under the tongue). Temperature measurements and / or indications may be used by clinicians and / or caregivers to, for example, determine when to replace the mouth-cooling device (i.e., when the mouth-cooling device is no longer cooling to the desired temperature) and / or provide a feedback mechanism by which increase and / or decrease cooling provided by the mouth-cooling device.[000157] Additionally, or alternatively, in some examples, a mouth-cooling device, such as the mouth-cooling devices disclosed herein, may be configured to cooperate with an external reservoir of heat-absorbing material from which heatabsorbing material may be provided to the mouth-cooling device. At times, the external reservoir may be embodied as a headpiece or strap configured to be worn by the wearer during mouth-cooling device use. In these examples, the heatabsorbing material may be circulated through the mouth-cooling device either passively or actively. In some circumstances, the headpiece may be decorated as, for example, a helmet used in certain professions (e.g., fire fighter, policeman, aviation pilot, etc.) and / or a costume used by characters (e.g., superhero costumes, animal costumes, etc.), to increase adherence in certain patient populations, like children. Additionally, or alternatively, mouth-cooling devices may be come in a variety of colors and / or include a decorative component so that a user may select a mouth-cooling device from a plurality of options to, for example, increase willingness to use, especially by pediatric patients.[000158] Additionally, or alternatively, one or more of the mouth-cooling devices disclosed herein may include one or more features and / or may be configured to cooperate with one or more devices configured to increase compliance and / or adherence to cryotherapy treatment and / or distract patients during treatment to reduce anxiety. For example, in one example, the mouthcooling device may be configured to interface with an external electronic device (e.g., cell phone, videogame console, computer, etc.) so that, for example, the user may control on operation of the external electronic device with the mouth-coolingdevice when for example, playing a game using the mouth-cooling device and the external electronic device. For example, in one example, the mouth-cooling device may include and / or be coupled to a mechanical, electronic, and / or communication element such as a communication interface (e.g., a joystick, track pad, keypad, pressure sensor and / or touchscreen) that is configured to be activated by, for example, movements of a user’s tongue and / or head or by applying pressure with teeth when a mouth-cooling device is positioned within the user’s mouth. For example, in some examples, when the mouth-cooling device includes a joystick positioned on an internal side of a mouth-cooling device, the user may be encouraged to move the joystick while the mouth-cooling device is within their mouth. Movement of the joystick by the user may be communicated to a computer or processing device by, for example, a transceiver and / or transmitter in communication (via, for example, BLUETOOTH and / or another near-field communication protocol) with the joystick and an indication corresponding to movement of the joystick may be provided by the computer to a display device so that the user may visually observe movement of the joystick through, for example, a maze or in a video game. This may serve to distract the user from discomfort caused by cooling his or her mouth and / or receiving a chemotherapy infusion. [000159] Additionally, or alternatively, in some examples, a mouth-cooling device, such as the mouth-cooling devices disclosed herein may include and / or be configured to cooperate with a non-toxic insulating and / or absorbent member positioned on all or a portion of an external surface thereof. For example, the insulating and / or absorbent member may be positioned on external surfaces configured to reside on the outside of the teeth (e.g., proximate to the cheek), inside of the teeth (e.g., proximate to the tongue), and / or between the teeth and may be an attachment to and / or part of one or more of the mouth-cooling devices disclosed herein. The insulating and / or absorbent member may be sized, positioned, and / or configured to insulate the teeth from the cooling media and / or prevent discomfort from cooling and / or absorb saliva from the mouth to, for example, prevent pooling of saliva within the oral cavity which may cause discomfort when cooled by the cooling device by, for example, forming pools of cooled saliva within the mouth.[000160] At times, the insulating and / or absorbent member may be configured to be of adjustable shape and / or size to, for example, conform to and / or form fit to the user’s teeth and / or anatomy. This may be achieved via, for example, flexible (e.g., wire or bendable plastic), shape memory, and / or compressible materials (e.g., gel within a reservoir or foam). The insulating and / or absorbent member may have a pre-set shape and / or configuration and / or may be fit or conformed prior to and / or during use (e.g., the user biting down or pressing his / her cheek and / or tongue against it). When the insulating and / or absorbent member is not integrated into the mouth-cooling device, it may be attached thereto via any acceptable mechanism (e.g., snap, press fit, tongue and groove, magnets, clip, etc.) and / or sprayed on as, for example, a non-toxic foam, gel, and / or hydrogel component configured to gel when exposed to saliva that on some occasions may be sprayed, squirted, and / or otherwise applied to one or more surfaces thereof. At times, the insulating and / or absorbent member may be flavored and / or lubricated to, for example, ease insertion and / or extraction of the mouth-cooling device into / out of the user’s mouth. [000161] Additionally, or alternatively, in some examples, distribution of the heat-absorbing material within, for example, the inner and / or outer reservoirs of the mouth-cooling devices disclosed herein may be adjustable by the user via, for example, exertion of pressure or force thereon. For example, a mouth-cooling device may include one or more chambers and / or channels for holding heatabsorbing material and the user may press upon and / or bite down on these chambers to facilitate movement and / or distribution of the heat-absorbing material throughout the channels and / or reservoirs.[000162] Additionally, or alternatively, in some examples, a mouth-cooling device like one or more of the mouth cooling devices disclosed herein may be of a freeform and / or expanding shape such that, for example, when inserted into the mouth and / or exposed to saliva, it expands to fill the negative space of the oral cavity. Additionally, or alternatively, in some examples, a mouth-cooling device like one or more of the mouth cooling devices disclosed herein may include and / or be configured to cooperate with adjustment putty or other malleable substance (e.g., wax) configured to smooth edges of the mouth cooling devices disclosed herein and / or fill in gaps or otherwise adjust a size and / or shape of the mouth cooling devices disclosed herein to, for example, increase user comfort and / or efficacy.Add itionally , or alternatively, in some examples, a mouth-cooling device like one or more of the mouth cooling devices disclosed herein may be coated with and / or manufactured from an antimicrobial or hydrophobic coating to, for example, facilitate cleaning and / or impeded growth of microbes and / or accumulation of debris and / or contamination.

Claims

CLAIMSWhat is claimed is:1 . A mouth-cooling device comprising: a body configured to fit within a user’s mouth, the body comprising: an left outer reservoir including a left outer reservoir cavity, the left outer reservoir being shaped to extend between a left superior oral vestibule cavity of the user and a left inferior vestibule cavity of the user when worn with a front side of the left outer reservoir being configured to be placed proximate to the left superior oral vestibule cavity and the left inferior oral vestibule cavity and a back side of the left outer reservoir being configured to be proximate to a left buccal side of the user’s upper jaw and lower jaw when worn by the user; an right outer reservoir including a right outer reservoir cavity, the right outer reservoir being shaped to extend between a right superior oral vestibule cavity of the user and a right inferior vestibule cavity of the user when worn with a front side of the right outer reservoir being configured to be placed proximate to the right superior oral vestibule cavity and the right inferior oral vestibule cavity and a back side of the right outer reservoir being configured to be proximate to a right buccal side of the user’s upper jaw and lower jaw when worn by the user; an left inner reservoir including a left inner reservoir cavity, the left inner reservoir being shaped to extend between a left lingual side of the user’s upper jaw and a left lingual side of the user’s lower jaw and abut a left side of the user’s tongue when worn; a right inner reservoir including a right inner reservoir cavity, the right inner reservoir being shaped to extend between a right lingual side of the user’s upper jaw and a right lingual side of the user’s lower jaw and abut a right side of the user’s tongue when worn; a connecting portion configured to connect the left outer reservoir, the right outer reservoir, the left inner reservoir, and the right inner reservoir and fit between the user’s upper jaw and lower jaw when worn, wherein the left inner reservoir and the right inner reservoir flex laterally about a slit therebetween an exterior component that includes anexternal cavity, the exterior component being sized and configured to reside outside the user’s mouth when the mouth-cooling device is worn and extend from approximately a left commissure of the user’s lips to approximately a right commissure of the user’s lips, wherein a volume of the heat-absorbing material is resident within the external cavity; and a heat-absorbing material resident within the left outer reservoir cavity, the right outer reservoir cavity, the left inner reservoir cavity, and the right inner reservoir cavity, the heat-absorbing material being configured to absorb heat from inside and outside the user’s mouth when the mouth-cooling device is positioned therein.

2. The mouth-cooling device of claim 1 , wherein the mouth-cooling device is configured to reduce capillary blood flow within the user’s mouth, lips, and / or cheeks when worn.

3. The mouth-cooling device of claim 1 , wherein the mouth-cooling device is configured to induce vasoconstriction within the user’s mouth, lips, and / or cheeks when worn.

4. The mouth-cooling device of claim 1 , wherein the mouth-cooling device is configured to reduce a metabolism rate of cells within the user’s mouth, lips, and / or cheeks when worn.

5. The mouth-cooling device of claim 4, wherein the cells are oral epithelial stem cells.

6. The mouth-cooling device of any one of claims 1 -5, wherein the body and heatabsorbing material are configured to prevent or mitigate development of oral mucositis for the user.

7. The mouth-cooling device of any one of claims 1 -5, wherein the body and heatabsorbing material are configured to prevent oral mucositis for the user before, during, or after the user receives chemotherapy treatment and / or radiotherapy treatment.

8. The mouth-cooling device of any one of claims 1 -5, wherein a portion of the mouth-cooling device is malleable.

9. The mouth-cooling device of any one of claims 1 -5, wherein a portion of the mouth-cooling device is configured to deform to be proximate to the user’s mouth, lips, or skin.

10. The mouth-cooling device of any one of claims 1-5, wherein a portion of the mouth-cooling device is configured to deform thereby conforming to user anatomy.11 . The mouth-cooling device of any one of claims 1 -5, further comprising; wherein the left outer reservoir and the right outer reservoir flex laterally about an open channel therebetween.

12. The mouth-cooling device of any one of claims 1-5, wherein the body includes an opening sized and configured to accept insertion of a plug therein, wherein the plug seals the heat-absorbing material within at least one of the left outer reservoir cavity, the right outer reservoir cavity, the left inner reservoir cavity, and the right inner reservoir cavity.

13. The mouth-cooling device of claim 12, wherein a volume of heat-absorbing material may be removed from and / or added to at least one of the left outer reservoir cavity, the right outer reservoir cavity, the left inner reservoir cavity, and the right inner reservoir cavity via removal of the plug from the opening.

14. The mouth-cooling device of any of the above claims, wherein the body is comprised of an upper portion and a lower portion.

15. The mouth-cooling device of claim 14, wherein the upper portion and the lower portion form a single component by mechanical attachment.

16. The mouth-cooling device of any one of claims 1-5, further comprising an exterior component that includes an external cavity, the exterior component being sized and configured to reside outside the user’s mouth when the mouth-cooling device is worn and extend from approximately a left commissure of the user’s lips to approximately a right commissure of the user’s lips, wherein a volume of the heat-absorbing material is resident within the external cavity17. The mouth-cooling device of claim 16, wherein the exterior component is configured to extend between a left commissure of the user’s mouth and a right commissure of the user’s mouth when the body is positioned within the user’s mouth.

18. The mouth-cooling device of claim 16, wherein the exterior component is configured to extend between and beyond a left commissure of the user’s mouth and a right commissure of the user’s mouth when the body is positioned within the user’s mouth.

19. The mouth-cooling device of claim 16, wherein the exterior component is configured to cool the user’s lips and skin proximate to the user’s lips when the mouth-cooling device is worn.

20. The mouth-cooling device of any of claims 16-19, wherein the exterior component is sized and configured to cool the user’s skin opposing at least one of a superior oral vestibule and an inferior oral vestibule of the user when the mouthcooling device is worn.

21. The mouth-cooling device of claim 16, wherein the exterior component is sized and configured to cool the user’s lips when the mouth-cooling device is worn.

22. The mouth-cooling device of claim 16, wherein the exterior component is sized and configured to hold the mouth-cooling device in place within the user’s mouth when the mouth-cooling device is worn.

23. The mouth-cooling device of claim 16, wherein an interior side of the exterior component includes a retention feature configured to hold the mouth-cooling device in place within the user’s mouth when the mouth-cooling device is worn.

24. The mouth-cooling device of claim 23, wherein the retention feature is at least one of a ridge, an extension, a plurality of extensions, and a deformable member.

25. The mouth-cooling device of claim 23, wherein the retention feature includes a retention feature cavity filled with heat-absorbing material.

26. The mouth-cooling device of any one of claims 1-5, wherein the exterior component is removably attached to the body.

27. The mouth-cooling device of claim 26, wherein the body includes a first mating feature and the exterior component includes a second mating feature configured to cooperate with the first mating feature to removably attach the exterior component to the first mating feature.

28. The mouth-cooling device of claim 27, wherein the first mating feature is a coupling configured to accept insertion of the second mating feature therein.

29. The mouth-cooling device of claim 27, wherein the first mating feature is a threaded coupling configured to accept insertion of the second mating feature therein, the second mating feature including threads configured to align with corresponding treads of the treaded coupling so that the second mating feature may be screwed into first mating feature, thereby attaching the exterior component to the body.

30. The mouth-cooling device of claim 27, wherein the first mating feature is configured to snap together with the second mating feature thereby attaching the exterior component to the body.31 .The mouth-cooling device of claim 27, wherein the first mating feature is held in place relative to the second mating feature via at least one of a sealant, a sleeve, an elastic band, a zip tie, and a gasket.

32. The mouth-cooling device of claim 16, wherein the exterior component is deformable so that it may be adapted to patient anatomy.

33. The mouth-cooling device of claim 16, wherein the exterior component further comprises at least one of a handle and a decorative feature.

34. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is sealed within the body.

35. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is biocompatible.

36. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is at least one of saline, water, a hydrogel, encapsulated water particles, encapsulated saline particles, gelatin, a suspension of water and a thickening agent, a combination of water and methylcellulose, and an emulsion of water and a thickening agent.

37. The mouth-cooling device of claim 17, wherein the thickening agent is at least one of a non-toxic material, a cellulose ether, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and xanthan gum.

38. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is cooled to a temperature below 37 degrees Celsius prior to insertion into the user’s mouth.

39. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is cooled to a temperature below 20 degrees Celsius prior to insertion into the user’s mouth.

40. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is cooled to a temperature within a range of 4-25 degrees Celsius prior to insertion into the user’s mouth.

41. The mouth-cooling device of any one of claims 1-5, wherein the heat-absorbing material is a phase change material configured to change phase upon absorption of heat from the user’s mouth.

42. The mouth-cooling device of any one of claims 1 -5, wherein the mouth-cooling device is dishwasher safe.

43. The mouth-cooling device of any one of claims 1-5, wherein the mouth-cooling device is configured to tolerate sterilization via application of heat, steam, and / or a chemical sterilizing agent.

44. A kit comprising: a plurality of any of the mouth-cooling devices of any one of claims 1 -5; and a case configured to hold the plurality of mouth-cooling devices.

45. The kit of claim 44, wherein the case includes a refrigeration device.

46. The kit of claim 44, wherein the case comprises a thermally-insulating material.

47. The kit of claim 44, wherein the plurality of mouth-cooling devices are all the same size.

48. The kit of claim 44, wherein the plurality of mouth-cooling devices are of different sizes.

49. The kit of claim 44, wherein the kit is personalized to the user.

50. The kit of claim 44 , further comprising at least one of a sterilization solution, a sterilization device, and a sterilization pouch suitable for use with an autoclave.51 . A method comprising: placing the body of any of the mouth-cooling devices of claims 1-24 within the mouth of a user; and positioning the exterior portion of any of the mouth-cooling devices of claims 1 - 24 outside the user’s mouth proximate to the user’s lips so that the body and the exterior portion absorb heat from the user’s mouth, lips, and / or cheeks, reduce capillary blood flow within the user’s mouth, lips, and / or cheeks, induce vasoconstriction within the user’s mouth or lips, reduce a metabolism rate of cells within the user’s mouth, lips, and / or cheeks, or prevent or mitigate development of oral mucositis for the user.

52. The method of claim 51 , wherein the mouth-cooling device is placed in the user’s mouth prior to, during, and / or while the user receives a chemotherapy treatment.

53. The method of claims 51 or 52, wherein the mouth-cooling device is a first mouth-cooling device, the method further comprising: removing the first mouth-cooling device from the user’s mouth; and placing a second mouth-cooling device into the user’s mouth.

54. The method of claim 53, further comprising: monitoring a temperature of the user’s mouth, wherein the first mouth-cooling device is removed from the user’s mouth responsively to a determination that the user’s mouth has warmed above a threshold temperature.

55. The method of claim 54, wherein the threshold temperature is 30 degrees Celsius, 25 degrees Celsius, 20 degrees Celsius, 15 degrees Celsius, or 10 degrees Celsius.

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