WO2025117762A1 - Oral device and methods of producing and using same - Google Patents

Abstract

An oral device configured for delivery of a liquid to the mouth of the subject is disclosed, along with kits and systems containing same, and methods of producing and using same. The oral device includes a base component comprising a reservoir that is configured for receiving a volume of liquid and contains a wicking agent disposed therein that dispenses liquid via capillary action. The base component also includes at least one opening formed therein for delivery of the liquid to the subject.

Description

ORAL DEVICE AND METHODS OF PRODUCING AND USING SAME

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit under 35 USC § 119(e) of US Provisional Application No. 63/603,843, filed November 29, 2023. The entire contents of the above-referenced patent application(s) are hereby expressly incorporated herein by reference.

BACKGROUND

[0002] Xerostomia, also known as dry mouth, is a condition where the mouth feels dry due to lack of saliva. There are many causes of xerostomia, including (but not limited to) cancer, Sjogren's disease, aging, diabetes, surgery, strokes, HIV/AIDs, nerve damage, tobacco/alcohol/drug use, hundreds of medications, and other sources. In the US, the incidence of oral cancer alone is 11.5 out of 100,000; this is equivalent to almost 40,000 new cases per year. Thus, in just ten years, there are at least 400,000 potential cases of xerostomia from oral cancer.

[0003] The most dramatic damage to saliva production comes from the radiation treatment of many of these illnesses. It is unforgiving and causes serious damage to saliva glands along with other important functionaries of the mouth. Once afflicted, the incidence of recovery is small, and usually the affliction is a lifetime sentence. Patients with this condition are condemned to suffer consequences of no moisture in the mouth, especially in the nighttime hours. This deprivation causes sleep disorders; declining dental health; increased plaque, tooth decay, and gum disease; mouth and skin sores; thrush; and problems with chewing and swallowing (which thereby result in poor nutritional health). In addition, this deprivation of moisture in the mouth also results in negative daily interactions and interpersonal relationships.

[0004] The nighttime hours are especially difficult because of snoring, dry air, open mouth, and because one cannot drink while sleeping without awakening. Saliva is important for sleep.

[0005] Ideally, restoration of saliva would be the first choice of intervention; however, this remedy is unlikely under the current state of discovery. In fact, there are no known remedies, surgical or otherwise, where saliva glands can be restored to natural production. The currently available treatments for xerostomia (i.e., the use of candy, mints, and/or gum and/or increased fluid intake during the day) do not work to stimulate saliva production, and these treatments provide no relief at night. Therefore, there is a need in the art for treatments that can replicate the function of the saliva glands. Daytime drinking is a convenient way of supplying moisture to the mouth so that normal activities are not interrupted. For nighttime, however, this remedy is not possible. In addition, saliva production normally decreases at night, thus further contributing to the deficit. Also, saliva plays an important role in lubricating the esophagus at night, and thus a saliva deficit has detrimental effects on both comfort as well as functional aspects. Therefore, there is a need in the art for new treatments that restore moisture to the mouth during sleep.

[0006] US Patent Application Publication No. 2007/0204867 discloses a mouth moisturizing appliance for providing a controlled flow of liquid directly to a user's mouth to alleviate dry mouth conditions. The appliance utilizes a mouthpiece that is connected to a liquid reservoir assembly that is equivalent to an IV bag and tubing having a roller clamp and backflow prevention valve. Liquid is delivered from the IV bag into the reservoir by gravity feed, and the rate of flow through the tubing is controlled by the roller clamp. Liquid delivered through the tubing is then released into an open channel of the mouthpiece that is in contact with the dentures of a patient, where the liquid simply seeps from the channel past the dentures. The appliance may optionally contain various ports disposed about the surfaces of the mouthpiece that allow for passive release of fluid from the channel into the user's mouth.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is a perspective view of one non-limiting embodiment of an oral device constructed in accordance with the present disclosure with separated base component and upper component.

[0008] FIG. 2 is a perspective view of the base component of the oral device of FIG. 1.

[0009] FIG. 3 is a side view of the assembled oral device of FIG. 1, wherein the upper component is illustrated transparently for ease of distinguishing its structure from that of the base component.

[0010] FIG. 4 is a cross-sectional view of the assembled oral device of FIGS. 1-3, depicting a left portion of the oral device.

[0011] FIG. 5 is a cross-sectional view of the assembled oral device of FIGS. 1-3, as viewed from the bottom of the device.

[0012] FIG. 6 is a cross-sectional, cutaway view of a subject's mouth having one non-limiting embodiment of the oral device of the present disclosure secured therein.

[0013] FIG. 7 is a perspective view of another non-limiting embodiment of an oral device constructed in accordance with the present disclosure. [0014] FIG. 8 is a top plan view of three different non-limiting embodiments of oral devices constructed in accordance with the present disclosure.

[0015] FIG. 9 depicts another non-limiting embodiment of an oral device constructed in accordance with the present disclosure. Panel (A) contains a partially cutaway view of the assembled oral device, Panel (B) is an isometric view of the device with base and upper components separated, and Panel (C) contains a perspective view of the oral device with the base and upper components snapped together.

[0016] FIG. 10 depicts yet another non-limiting embodiment of an oral device constructed in accordance with the present disclosure. Panel (A) contains a top plan view of the device, and Panel (B) contains an isometric view of the device.

[0017] FIG. 11 depicts another non-limiting embodiment of an oral device constructed in accordance with the present disclosure. Panel (A) contains a top plan view of the device, Panel (B) contains an isometric view of the device, and Panel (C) contains a partially cutaway view of the device.

[0018] FIG. 12 graphically illustrates an analysis of theoretical flow rate R vs. hole radius r. r’ corresponds with the flow rate of 1 oz/hr.

[0019] FIG. 13 graphically illustrates a wetting analysis of wick distance (Y) vs time (X). The cubic equation illustrates the natural curve of the data, and R² indicates the accuracy of the fit.

[0020] FIG. 14 is a photo of one non-limiting embodiment of a 3-D printed mouth guard constructed in accordance with the present disclosure for experimental design purposes.

[0021] FIG. 15 illustrates one non-limiting embodiment of an oral device constructed in accordance with the present disclosure for experimental purposes.

DETAILED DESCRIPTION

[0022] Before explaining at least one embodiment of the inventive concept(s) in detail by way of exemplary language and results, it is to be understood that the inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components set forth in the following description. The inventive concept(s) is capable of other embodiments or of being practiced or carried out in various ways. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments are meant to be exemplary - not exhaustive. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. [0023] Unless otherwise defined herein, scientific and technical terms used in connection with the presently disclosed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. The foregoing techniques and procedures are generally performed according to conventional methods well known in the art and as described in various general and more specific references that are cited and discussed throughout the present specification. The nomenclatures utilized in connection with, and the laboratory procedures and techniques of, analytical chemistry, synthetic organic chemistry, and medicinal and pharmaceutical chemistry described herein are those well-known and commonly used in the art. Standard techniques are used for chemical syntheses and chemical analyses.

[0024] All patents, published patent applications, and non-patent publications mentioned in the specification are indicative of the level of skill of those skilled in the art to which this presently disclosed inventive concept(s) pertains. All patents, published patent applications, and nonpatent publications referenced in any portion of this application are herein expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0025] All of the compositions and/or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of the inventive concept(s) have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions and/or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the inventive concept(s). All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the inventive concept(s) as defined by the appended claims.

[0026] As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

[0027] The use of the term "a" or "an" when used in conjunction with the term "comprising" in the claims and/or the specification may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one." As such, the terms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, reference to "a compound" may refer to one or more compounds, two or more compounds, three or more compounds, four or more compounds, or greater numbers of compounds. The term "plurality" refers to "two or more."

[0028] The use of the term "at least one" will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term "at least one" may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100/1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. The use of ordinal number terminology (i.e., "first," "second," "third," "fourth," etc.) is solely for the purpose of differentiating between two or more items and is not meant to imply any sequence or order or importance to one item over another or any order of addition, for example.

[0029] The use of the term "or" in the claims is used to mean an inclusive "and/or" unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive. For example, a condition "A or B" is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0030] As used herein, any reference to "one embodiment," "an embodiment," "some embodiments," "one example," "for exam pie," or "an example" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearance of the phrase "in some embodiments" or "one example" in various places in the specification is not necessarily all referring to the same embodiment, for example. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims.

[0031] Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of errorfor a composition/apparatus/ device, the method beingemployed to determine the value, or the variation that exists among the study subjects. For example, but not by way of limitation, when the term "about" is utilized, the designated value may vary by plus or minus twenty percent, or fifteen percent, or twelve percent, or eleven percent, or ten percent, or nine percent, or eight percent, or seven percent, or six percent, or five percent, or four percent, or three percent, or two percent, or one percent from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the art. [0032] As used in this specification and claim(s), the words "connprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include"), or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0033] The term "or combinations thereof" as used herein refers to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0034] As used herein, the term "substantially" means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree. For example, when associated with a particular event or circumstance, the term "substantially" means that the subsequently described event or circumstance occurs at least 80% of the time, or at least 85% of the time, or at least 90% of the time, or at least 95% of the time. For example, the term "substantially adjacent" may mean that two items are 100% adjacent to one another, or that the two items are within close proximity to one another but not 100% adjacent to one another, or that a portion of one of the two items is not 100% adjacent to the other item but is within close proximity to the other item.

[0035] As used herein, the phrases "associated with" and "coupled to" include both direct association/binding of two moieties to one another as well as indirect association/binding of two moieties to one another.

[0036] The term "patient" or "subject" as used herein includes human and veterinary subjects. "Mammal" for purposes of treatment refers to any animal classified as a mammal, including (but not limited to) humans, domestic and farm animals, nonhuman primates, and any other animal that has mammary tissue.

[0037] Turning now to the inventive concepts, disclosed herein are oral devices which administer fluid into a subject's mouth. The oral devices may be utilized to deliver fluid for any purpose; for example, but not by way of limitation, the oral devices may be utilized at night in order to treat xerostomia. The devices utilize a reservoir containing a wick to transport liquid to the device and capillary action via the wick to dispense liquid from the reservoir through openings formed in the device.

[0038] The presently disclosed devices and methods and methods of production and use thereof possess certain advantages over the prior art. For example (but not by way of limitation), the devices are simple and require no external power source, are compact and light weight, utilize a small liquid reservoir, are inexpensive and low maintenance, have disposable parts, are easy to clean and sterilize, and are non-obtrusive. The devices are ergonomically designed to allow the subject to sleep while the device is functioning. The devices are designed to ensure a steady fluid flow if the subject changes to a different position in bed (efficacy and safety). Therefore, the devices of the present disclosure can be used to provide an improvement in the quality of life of a significant percent of the population with dry mouth.

[0039] Certain non-limiting embodiments of the present disclosure are directed to an oral device configured for delivery of a liquid to a mouth of a subject. The oral device includes a base component having a substantially U-shape to generally correspond to a dental arch of the subject. The base component includes a reservoir extending from an upper surface thereof and configured for receiving a volume of liquid. The reservoir has a wicking agent disposed therein that dispenses liquid via capillary action. The reservoir also has at least one opening formed in a sidewall thereof for filling the reservoir with liquid, and at least one opening formed in a surface (such as, but not limited to, a sidewall or lower surface) thereof for delivery of the liquid to the subject.

[0040] In certain particular embodiments, the oral device may further include an upper component which frictionally engages with the base component. The upper component has an upper surface, a lower surface, and optionally an outer flange extending substantially perpendicularly from at least a portion of an outer edge of the upper surface. The upper component is configured to engage at least a portion of the upper teeth of the subject. The attachment of the upper component to the base component seals the at least one opening formed in the sidewall of the base component, thereby retaining liquid in the reservoir so that it is dispensed at a controlled rate through the at least one opening in the lower end of the base component.

[0041] In certain particular (but not limiting) embodiments, the base component has an upper surface, a lower surface, an optional outer flange extending substantially perpendicularly from a front outer edge of the upper surface, and a groove formed between the outer flange and the reservoir, and wherein the upper component frictionally engages with the groove of the base component. In addition, the upper component may further comprise a back flange extending substantially from at least a back outer edge of the upper surface thereof, wherein the back flange engages the at least one opening in the sidewall of the reservoir to seal the liquid within the reservoir.

[0042] The oral devices described herein may be designed for single use or multiple uses. For example, but not by way of limitation, the oral devices may be reusable. The oral device can be reused multiple times and for a duration of time such as (but not limited to) at least about one day, about two days, about three days, about four days, about five days, about six days, about seven days, about eight days, about nine days, about 10 days, about 14 days, about one week, about two weeks, about three weeks, about four weeks, about five weeks, about six weeks, about one month, about two months, and the like, as well as a range formed from two of the above values (e.g., a range of from about one week to about one month, a range of from about two weeks to about one month, a range of from about 7 to about 14 days, etc.).

[0043] Certain non-limiting embodiments of the present disclosure are directed to a method of producing any of the oral devices disclosed or otherwise contemplated herein. In the methods, at least the base component is produced by a production method (such as, but not limited to, thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and the like, as well as any combinations thereof). If present, the upper component is also produced by a production method (such as, but not limited to, thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and the like, as well as any combinations thereof). In addition, any elements of the base component and/or upper component not during the forming process or added post-processing; for example (but not by way of limitation), the at least one opening for receiving liquid into the reservoir and/or the at least one opening for dispensing liquid from the reservoir may be added post-processing by a method such as (but not limited to) drilling, laser drilling, and the like, as well as any combinations thereof). If the upper component is present, then the method may include the step of snapping or otherwise attaching (or releasably attaching) the upper component to the base component. In addition, the method may further include the step of sterilizing the oral device.

[0044] Certain non-limiting embodiments of the present disclosure include a kit or system comprising a plurality of oral devices having different shapes and/or sizes. Such a kit or system will allow a user to select a shape/size that most closely approximates the subject's mouth. For example (but not by way of limitation), the kit or system may include at least one size/shape for a child and at least one size/shape for an adult. Alternatively, the kit or system may include multiple sizes/shapes for children and/or multiple sizes/shapes for adults. In one non-limiting embodiment, the kit or system may include multiple sizes/shapes for children based on the ages thereof (i.e., infant, toddler, adolescent, etc.). In one non-limiting embodiment, the kit or system may include multiple designated sizes/shapes (e.g., small, medium, large, extra-large, etc.).

[0045] Certain non-limiting embodiments of the present disclosure include a method of using the oral device disclosed or otherwise contemplated herein. In the method, liquid is disposed in the reservoir of the base component of the oral device and sealed therewithin (for example, but not by way of limitation, by attaching the optional upper component to the base component). Then at least a portion of the oral device containing the reservoir is disposed within an oral cavity of a subject, and the oral device is retained within the oral cavity of the subject for a period of time so that at least a portion of the liquid in the reservoir is delivered at a controlled rate to the oral cavity of the subject.

[0046] The liquid utilized in accordance with the present disclosure may be any liquid for which controlled dispensing to a subject is desired. Non-limiting examples of liquids that may be dispensed by the oral devices of the present disclosure include water, oral solutions and rinses, electrolyte containing solutions, nutritional compositions, supplement compositions, prescription and over-the-counter medications, and the like, as well as any combinations thereof.

[0047] In a particular (but non-limiting) embodiment, the method is further defined as a method of treating xerostomia.

[0048] The methods of the present disclosure may optionally include one or more additional steps. Non-limiting examples of optional steps include: selecting the oral device from a plurality of oral devices having different sizes; heating the upper component of the oral device to a temperature at which at least a portion of the material from which the upper component of the device is formed is moldable and disposing the upper component of the oral device within the mouth of the subject so that at least a portion of the upper component is molded to specifically conform to at least a portion of the upper teeth of the subject; and/or removing the oral device from the cavity of the subject and then repeating any of the steps one or more times for reuse of the oral device.

[0049] FIGS. 1-6 illustrate a first non-limiting embodiment of an oral device 10 constructed in accordance with the present disclosure. The oral device 10 includes a base component 12 and an optional upper component 14. The base component 12 (shown in detail in FIG. 2) includes a base plate 16 having an upper surface 18, a lower surface 20, and an outer edge 22 having a front portion 24 (FIG. 2), a left side portion 26, a right side portion 28, a left back portion 30, a right back portion 32, and an inner portion 34. The base component 12 also includes an outer flange 36 extending substantially perpendicularly at least a portion of the base plate 16, such as (but not limited to) from the front portion 24 and at least a portion of each of the left and right side portions 26 and 28 of the outer edge 22 of the base plate 16.

[0050] The base component 12 further includes a housing 40 extending from and attached to the base plate 16 in the general vicinity of the inner portion 34 of the outer edge 22 of the base plate 16 and at least a portion of the left and right back portions 30 and 32 of the outer edge 22 of the base plate 16; the housing 40 and base plate 16 form a reservoir 42 that can receive a volume of liquid. Further, a groove 44 is formed between the outer flange 36, the housing 40, and the portion of the base plate 16 disposed therebetween.

[0051] The reservoir 42 has at least one opening 50 formed therein (such as, but not limited to, through the housing 40 (as depicted in FIG. 2) and/or the base plate 16) for receiving liquid therethrough so as to fill the reservoir 42 with liquid. In addition, as can be seen in detail in FIGS. 2 and 4-5, a wicking agent 52 is disposed within the reservoir 42. The wicking agent 52 absorbs liquid received within the reservoir 42 and then dispenses the liquid via capillary action over a period of time. Also, the reservoir 42 further includes at least one opening 54 formed therein (such as, but not limited to, through the housing 40 and/or the base plate 16 (with FIGS. 2 and 5 indicating three openings 54 formed in the base plate 16)), and the at least one opening 54 dispenses liquid from the reservoir 42 at a controlled rate.

[0052] In use, the at least one opening 50 used for filling the reservoir 42 is sealed by any mechanism known in the art so that, once the reservoir 42 is filled with liquid, the liquid is dispensed from the reservoir 42 at a controlled rate through the at least one opening 54. One non-limiting example of a mechanism by which the at least one opening 50 is sealed is via contact with a portion of the upper component 14, as described in greater detail herein after.

[0053] As shown in FIG. 1, the oral device 10 optionally includes the upper component 14 which frictional ly engages with the base component 12. The upper component 14 has an upper surface 60 having an outer edge 62 and an inner edge 64, a lower surface 66, and an outer flange 68 extending substantially perpendicularly from at least a portion of the outer edge 62 of the upper surface 60, and an inner flange 70 extending substantially perpendicularly from at least a portion of the inner edge 64 of the upper surface 60; also, a groove 72 is formed between the outer and inner flanges 68 and 70. The upper component 14 is configured to engage at least a portion of the upper teeth of the subject within at least a portion of the groove 72. [0054] In addition, in one non-limiting embodiment, the attachment of the upper component 14 to the base component 12 seals the at least one opening 50 formed in the reservoir 42 of the base component 12, thereby retaining liquid received in the reservoir 42 so that it can be dispensed from the reservoir 42 at a controlled rate via capillary action through the at least one opening 54. For example (but not by way of limitation), a portion of the lower surface 66 and/or inner flange 70 of the upper component 14 pushes into the at least one opening 50 lightly to create a seal. Also, in certain particular (but non-limiting) embodiments, the upper component 14 can be releasably attached to the base component 12, whereby the upper component 14 can be dislodged from the base component 12 so that the reservoir 42 can be accessed multiple times for reuse of the oral device 10.

[0055] The base and upper components 12 and 14 may be formed of any polymeric materials that are generally regarded as safe for use in humans or other subjects and are durable and biocompatible materials that are strong enough to hold the device in place but malleable and soft enough to be comfortable for sleep. Non-limiting examples of materials that may be utilized include ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene and methyl acrylate copolymer, latex rubber, medical grade silicone rubber, liquid silicone rubber (LSR), acrylic resin, vinyl resin, and the like, as well as combinations, laminations, and copolymers thereof.

[0056] In a particular (but non-limiting) embodiment, at least a portion of the upper component 14 is formed of a heat-moldable polymer material, such as (but not limited to) materials commonly referred to the in the art as "boil and bite" materials, that can substantially conform to the subject's upper teeth upon heating. The expression "boil and bite" refers to the tested method of boiling an appliance to soften the material in order to mold it to the upper teeth of the subject, thereby forming an impression of the upper pallet in at least a portion of the groove 72 of the upper component 14. Non-limiting examples of materials that can be utilized in this manner include ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polyvinyl chloride (PVC), and the like, as well as combinations, laminations, and copolymers thereof.

[0057] The reservoir 42 may be provided with any shape, size, and configuration, so long as the reservoir 42 can function as described herein. In particular (but non-limiting) embodiments, the reservoir 42 is shaped and sized to hold a volume of liquid in a range of from about 5 ml to about 150 ml. The wicking agent 52 may be sized and configured to assume substantially all of the volume of the reservoir 42, or the wicking agent 52 may be sufficiently smaller than the reservoir 42 such that the reservoir 42 is provided with additional space therein. For example (but not by way of limitation), FIG. 4 depicts the reservoir 42 as possessing additional space around the wicking agent 52 that can hold additional amounts of liquid above that present in the wicking agent 52, if so desired.

[0058] The housing 40 of the reservoir 42 may be permanently attached to the base plate 16, or at least a portion of the housing 40 may be releasably attached to the base plate 16 to allow for removal and replacement of the wicking agent 52.

[0059] The wicking agent 52 may be provided with any shape, size, and/or configuration and may be formed from any inert material that can function in accordance with the present disclosure to provide the desired absorption and volume receiving rate, the total volume rate, and the desired controlled release rate so as provide a subject with a desired amount of moisture for a period of time (such as, but not limited to, while the subject is sleeping). Non-limiting examples of materials that may be utilized in accordance with the present disclosure include cotton, silk, treated and untreated cellulose, porous ceramic, and the like, as well as combinations and laminations thereof.

[0060] Non-limiting examples of pre-wetting times (i.e., absorption and volume receiving rates) include about 15 seconds, about 30 seconds, about 45 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 6 minutes, about 7 minutes, about 8 minutes, about 9 minutes, about 10 minutes, about 11 minutes, about 12 minutes, about 13 minutes, about 14 minutes, about 15 minutes, about 16 minutes, about 17 minutes, about 18 minutes, about 19 minutes, about 20 minutes, about 21 minutes, about 22 minutes, about 23 minutes, about 24 minutes, about 25 minutes, about 26 minutes, about 27 minutes, about 28 minutes, about 29 minutes, about 30 minutes, and the like, as well as any range formed from any two of the above values (e.g., a range of from about 30 seconds to about 30 minutes, a range of from about 10 minutes to about 20 minutes, etc.).

[0061] Non-limiting examples of total volumes that may be utilized include about 1 ml, about 2 ml, about 3 ml, about 4 ml, about 5 ml, about 6 ml, about 7 ml, about 8 ml, about 9 ml, about 10 ml, about 11 ml, about 12 ml, about 13 ml, about 14 ml, about 15 ml, about 16 ml, about 17 ml, about 18 ml, about 19 ml, about 20 ml, about 21 ml, about 22 ml, about 23 ml, about 24 ml, about 25 ml, about 26 ml, about 27 ml, about 28 ml, about 29 ml, about 30 ml, about 35 ml, about 40 ml, about 45 ml, about 50 ml, about 55 ml, about 60 ml, about 65 ml, about 70 ml, about 75 ml, about 80 ml, about 85 ml, about 90 ml, about 95 ml, about 100 ml, about 105 ml, about 110 ml, about 115 ml, about 120 ml, about 125 ml, about 130 ml, about 135 ml, about 140 ml, about 145 ml, about 150 ml, and the like, as well as any range formed from any two of the above values (e.g., a range of from about 10 ml to about 100 ml, a range of from about 5 ml to about 150 ml, a range of from about 50 ml to about 125 ml, a range of from about 12 ml to about 30 ml, etc.).

[0062] Non-limiting examples of controlled release rates that may be utilized in accordance with the present disclosure include about 0.1 ml/hr, about 0.5 ml/hr, about 1 ml/hr, about 1.5 ml/hr, about 2 ml/hr, about 2.5 ml/hr, about 3 ml/hr, about 3.5 ml/hr, about 4 ml/hr, about 4.5 ml/hr, about 5 ml/hr, about 6 ml/hr, about 7 ml/hr, about 8 ml/hr, about 9 ml/hr, about 10 ml/hr, about 11 ml/hr, about 12 ml/hr, about 13 ml/hr, about 14 ml/hr, about 15 ml/hr, about 16 ml/hr, about 17 ml/hr, about 18 ml/hr, about 19 ml/hr, about 20 ml/hr, about 21 ml/hr, about 22 ml/hr, about 23 ml/hr, about 24 ml/hr, about 25 ml/hr, about 26 ml/hr, about 27 ml/hr, about 28 ml/hr, about 29 ml/hr, about 30 ml/hr, and the like, as well as any range formed from any two of the above values (e.g., a range of from about 0.5 ml/hr to about 30 ml/hr, a range of from about 1 ml/hr to about 25 ml/hr, a range of from about 5 ml/hr to about 20 ml/hr, a range of from about 10 ml/hr to about 15 ml/hr, etc.).

[0063] It will be understood that the pre-wetting time, total volume, and controlled release rate will vary depending upon the liquid to be dispensed from the oral device.

[0064] Another factor in determining the controlled release rate is the size of the one or more openings 54. Non-limiting examples of diameters that may be utilized for the opening(s) 54 when the opening(5) 54 is/are circular include about 50 nm, about 75 nm, about 100 nm, about 125 nm, about 150 nm, about 175 nm, about 200 nm, about 225 nm, about 250 nm, about 275 nm, about 300 nm, about 325 nm, about 350 nm, about 375 nm, about 400 nm, about 425 nm, about 450 nm, about 475 nm, about 500 nm, about 525 nm, about 550 nm, about 575 nm, about 600 nm, about 625 nm, about 650 nm, about 675 nm, about 700 nm, about 725 nm, about 750 nm, about 775 nm, about 800 nm, about 825 nm, about 850 nm, about 875 nm, about 900 nm, about 925 nm, about 950 nm, about 975 nm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5 mm, and the like, as well as any range formed from any two of the above values (e.g., a range of from about 50 nm to about 5 mm, a range of from about 100 nm to about 4 mm, a range of from about 300 nm to about 3 mm, a range of from about 0.6 mm to about 2.2. mm, etc.).

[0065] Alternatively, the opening(s) 54 may be provided with a non-circular shape. Nonlimiting examples of surface areas that may be utilized forthe opening(s) 54 when the opening(5) 54 is/are non-circular include about 0.1 mm², about 0.11 mm², about 0.12 mm², about 0.13 mm², about 0.14 mm², about 0.15 mm², about 0.16 mm², about 0.17 mm², about 0.18 mm², about 0.19 mm², about 0.2 mm², about 0.21 mm², about 0.22 mm², about 0.23 mm², about 0.24 mm², about 0.25 mm², about 0.26 mm², about 0.27 mm², about 0.28 mm², about 0.29 mm², about 0.3 mm², about 0.31 mm², about 0.32 mm², about 0.33 mm², about 0.34 mm², about 0.35 mm², about 0.36 mm², about 0.37 mm², about 0.38 mm², about 0.39 mm², about 0.4 mm², about 0.45 mm², about 0.5 mm², about 0.55 mm², about 0.6 mm², about 0.65 mm², about 0.7 mm², about 0.75 mm², about 0.8 mm², about 0.85 mm², about 0.9 mm², about 0.95 mm², about 1 mm², about

1.1 mm², about 1.2 mm², about 1.3 mm², about 1.4 mm², about 1.5 mm², about 1.6 mm², about

1.7 mm², about 1.8 mm², about 1.9 mm², about 2 mm², about 2.1 mm², about 2.2 mm², about 2.3 mm², about 2.4 mm², about 2.5 mm², about 2.6 mm², about 2.7 mm², about 2.8 mm², about

2.9 mm², about 3 mm², about 3.1 mm², about 3.2 mm², about 3.3 mm², about 3.4 mm², about 3.5 mm², about 3.6 mm², about 3.7 mm², about 3.8 mm², about 3.9 mm², about 4 mm², about

4.1 mm², about 4.2 mm², about 4.3 mm², about 4.4 mm², about 4.5 mm², about 4.6 mm², about

4.7 mm², about 4.8 mm², about 4.9 mm², about 5 mm², and the like, as well as any range formed from two of the above values (a range of from about 0.1 mm² to about 5 mm², a range of from about 0.2 mm² to about 4.5 mm², a range of from about 0.25 mm² to about 4 mm², a range of from about 0.28 mm² to about 3.8 mm², etc.).

[0066] The base component 12 and upper component 14 of the oral device may be produced by any methods known in the art or otherwise disclosed herein. Non-limiting examples of production methods include thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and the like, as well as any combinations thereof. In addition, each of the elements of the base component 12 and upper component 14 may be produced during the forming process or added after the component is formed. For example (but not by way of limitation), the at least one opening 54 for dispensing liquid from the reservoir 42 may be produced during the forming process or added after forming. Non-limiting examples of methods of forming the at least one opening 54 include drilling, laser drilling, thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and the like, as well as any combinations thereof.

[0067] FIG. 6 depicts the placement of the oral device 10 within at least a portion of a mouth 102 of a subject 100. FIG. 6 is a cutaway view with the lips of the subject 100 not shown but with the upper teeth 104, lower teeth 106, upper gum 108, and lower gum 110 indicated. As can be seen, the oral device 10 is disposed within the mouth such that the reservoir 42 is disposed behind the upper teeth 104 so that the upper teeth 104 contact the groove 44 of the base component 12 (and/orthe groove 72 of the optional upper component 14, when present). While the lips of the subject 100 are not shown, in at least certain non-limiting embodiments, the oral device 100 is fully enclosed within the mouth 102 such that the lips of the subject 100 are disposed exterior to the outer flange 36 (and the outer flange 68 of the optional upper component 14, when present).

[0068] FIG. 7 is a perspective view of another non-limiting embodiment of an oral device IDA constructed in accordance with the present disclosure. The oral device 10A is identical in construction to the oral device 10 of FIGS. 1-6 and contains the same elements, with the exception that the oral device 10A contains two openings 54A disposed on each side of an inner sidewall 120 of a housing 40A through which the liquid is dispensed.

[0069] FIG. 8 is a top plan view of three different non-limiting embodiments of oral devices 10B, 10C, and 10D constructed in accordance with the present disclosure. The oral devices 10B- 10D are identical in construction to the oral device 10 of FIGS. 1-6 and contain the same elements, except that the elements are provided with slight changes to the sizes and configurations of certain elements, such as (but not limited to) the base plates 16B-16D, the outer flanges 36B-36D, and the housings 40B-40D. For example (but not by way of limitation), the oral device 10B possesses an extra reservoir 42B'; the oral device 10C has an altered shape to contour to the roof of a subject's mouth; and the oral device 10D has rounded corners for greater comfort.

[0070] FIGS. 9-11 depictthree additional non-limiting embodiments of oral devices 10E, 10F, and 10 G, respectively of the present disclosure.

[0071] In FIG. 9, the oral device IDE is similar in construction to the oral device 10A of FIG. 7. In Panels (A) and (B), an upper component 14E has a dip 130 in a center front portion of the outer flange 68E, which is intended to mold to the upper teeth. The base component 12E contains the reservoir 42E and the wicking agent that delivers the liquid. FIG. 9, Panel (C) illustrates how the two component pieces 12E and 14E fit together. This configuration is unique because the upper teeth are covered by a front plate of the upper component 14E, and there are four slotted holes 54E on each interior side of the base component for delivery of fluid.

[0072] For the oral device 10F of FIG. 10, the shape differs from the shape of the oral device IDE of FIG. 9 by being closer to the proportions of an actual mouth; in addition, a reservoir 42F' is added, and the number of holes 54F is reduced.

[0073] For the oral device 10G of FIG. 11, the front plate of the outer flange 68G has been eliminated from the upper component 14G of the device (and the base component 12G is also free of any front plate), thereby allowing the front teeth to be exposed. See FIG. 11, Panels (A) and (B). Panel (C) of FIG. 11 exposes the internal structure of the device 10G with respect to the wick, liquid, and holes. The upper component is shaped as in FIGS. 9 and 10 but with the missing front segment.

EXAMPLES

[0074] Examples are provided hereinbelow. However, the present disclosure is to be understood to not be limited in its application to the specific experimentation, results, and laboratory procedures disclosed herein after. Rather, the Examples are simply provided as one of various embodiments and are meant to be exemplary, not exhaustive.

[0075] The devices of the present disclosure are oral appliances that provide moisture to the mouth at a controlled rate. The device has been developed to deliver liquid using two different methods. In a first non-limiting embodiment of the device, the delivery method involves controlled capillary action where liquid flows into a reservoir of a mouthguard, wherein the reservoir contains a wick that absorbs the liquid and then releases the liquid into the mouth of the subject via capillary action.

[0076] The liquid flow is modeled theoretically using Darcy's laws and capillary action. Darcy's Law is represented by the Formula: dh

Q = —KA—, dx

where Q is the volumetric flow, K is the Hydraulic conductivity, A is the area, and is the

Hydraulic gradient.

[0077] Capillary action is represented by the Formula:

V = SA /t, where V is the volume of liquid absorbed, S is the sorbtivity constant, A is the area, and t is time. [0078] The various embodiments of the present disclosure provide mechanisms by which the velocity of the liquid can be controlled. For example (but not by way of limitation), changing the thickness of the wick and/or the diameter (and/or area) of the holes directly changes the volume flow rate.

[0079] Various studies have been conducted to optimize and expand the design and the operational capabilities of the oral devices of the present disclosure. Certain studies included variations to the wick design and reservoir design and the addition of an optional mouth guard moldable component. Engineering studies were aimed at understanding the flow rates of the liquid dispensed through the device and the number of holes necessary to drip adequate moisture to the mouth without contributing to asphyxia, aspiration, or swallowing problems. Various hole creation methods were evaluated, including laser drilling, standard drilling, and puncturing.

[0080] General structures of non-limiting embodiments of oral devices constructed in accordance with the present disclosure are shown in FIGS. 1-12. The oral devices/mouthpieces include a wick that resides in a bottom sealed volume of the mouthpiece. The wick provides structure for the water flow using well-understood capillary physics. The wick is connected to the reservoir, is attached to the lower body of the device, and can be filled with (and dispense) any desired liquid.

[0081] The bottom orifice/reservoir that holds the wick has a predetermined number of holes with predetermined sizes to control the flow of the liquid out of the oral device. The reservoir holding the wick is sterilized and sealed for multiple uses. The oral device can be reused multiple times and for a duration of time such as (but not limited to) at least about one month.

[0082] The device can be configured in multiple ways. For example, but not by way of limitation: the design can simply have a generic fit for the upper teeth; alternatively (and/or in addition thereto), at least a portion of an upper surface of the oral device can be formed of a moldable (i.e., "boil and bite") polymer so that upper surface can be provided with an impression of the teeth structure of the user. In addition, the main body of the oral device may be formed of different layers of structure. The device can be formed from one or more of several different materials, such as (but not limited to) polyethylene, ethylene-vinyl acetate (EVA), polyurethane, and polyvinyl acetate (PVA). The importance of the material is for a snug, comfortable fit where multiple uses do not cause sores, pain, or distortion of the product. The oral device must be designed for comfortable wear for a period sufficient enough to provide a good night's sleep (i.e., at least about 7 hours) and must also be designed to carefully avoid choking or aspiration. [0083] Variations can be made to the upper component and/or lower component of the design. In certain embodiments, the upper component uses a "boil and bite" method to conform to the upper pallet of the mouth. The lower component can connect to the upper component by snapping into the upper component.

[0084] Multiple experimental components have been explored for use in the wicking process. The simplest and most well-known substance that is common to the market is cotton. Results from experiments using a cotton wick and water as the liquid are provided herein below. However, it will be understood that this use is for purposes of example only and should be construed as limiting.

[0085] Theoretical Calculation of the Hole Size: In FIG. 12, the rate of water flow, R, vs the relative hole size radius, r, was calculated. That is, the size of the area at the front face of the hole where the water enters is different from the area of the back face of the hole at the exit. The upper curve is where the ratio of the two areas is %, and the lower curve is where the ratio of the two areas is 1. The relative radius, r', is marked on the abscissa and is designated with dashed lines to indicate the hole size that coordinates with the 1.0 oz/hr rate of water flow. Note, 1 fluid oz = ~30 ml. From the conversion rate, this curve can be utilized as a guide to determining the size, the number, and the variations of the holes in the device in order to determine the drip rate of the device.

[0086] Saturated Wick: Water saturated the cotton wick (1/6 inch in diameter) via capillary action at an average rate of about 1 cm per minute. Using a 15 cm long wick, water took on average 13 minutes to saturate. FIG. 13 graphically depicts the wicking distance (Y) vs time (X). The curve fits a cubic function with an accuracy of over 99%. The conclusion and implications are that prewetting the wick via capillary action before use is necessary so there is no delay in water flow after the device is inserted in the mouth. Prewetting can be done, on average, in about 15 minutes without any other complications. This can be placed as a direction, on the marketing box, for use of the device.

[0087] Capillary Action with the Force of Gravity: The experimental aim for this study was to determine how high the water can climb vertically using capillary action from the bottom of the wick to the top of the wick; this is action against the gravitational force. The result of this experiment was that the water climbed 18.5 cm vertically upward (bottom to top) after approximately 16 hours. Based on these results, it was concluded that ideally (however not by limitation), the wick should be horizontal so that capillary action dominates over the gravity force. [0088] Finding Volumetric Flow Rate of Wick: The experimental aim for this study was to determine the volumetric flow rate when the wick is horizontal using capillary action and Darcy's law only. In this experiment, a water bottle with a hole in the side was utilized with a wick emerging horizontally outward. The wick extended horizontally to a cup filled with paper towels to absorb the liquid. Capillary flow was allowed to take place for an hour. The mass of the cup and paper towels was measured before and after the experiment. It was found that the dry cup increased in mass (weight) from 17.29 g to 30.47 g, while the water level dropped 0.5 cm. The middle of the wick started to drip approximately 14 minutes into the experiment. Thus, with a horizontal wick, the water flowed at a rate of about 13.18 ml/hour. This is a reasonable rate and agrees with the estimated rate of saliva flow at night. The horizontal orientation is consistent with the wick being placed horizontally in the device.

[0089] Mouth guard Experiment 1

[0090] The aim of this experiment was to use a simulated 3-D printed mouth guard to test the flow rates from the mouth guard. FIG. 14 is a photo of a 3-D printed (PLA filament) mouth guard with two differently sized holes in the upper side of the mouth guard. The mouth guard has a mass of 3.83 g empty and a mass of 10.95 g when filled with water. It was found that the flow through the holes was not what was expected. When left alone with the mouthpiece full of water, the surface tension kept the water from dripping. When the surface tension was broken, the water rapidly flowed out. Subsequent experiments with holes in the horizontal region of the mouth guard showed the same "stiffness" surface tension when the cavity was filled. Once the surface tension was broken, the water began to drip in a smooth and consistent fashion. Fingers were utilized to release the surface tension; as such, the tongue of the wearer can be pressed against the bottom of the device to accomplish the same effect and begin the flow of fluids in the mouth.

[0091] Mouth guard Experiment 2

[0092] For this experiment, a 3D printed model of the experimental device, named MG11, was printed out of polylactic acid. FIG. 15 contains a drawing of MG11 used in the experiment. The MG11 is set upright with only one 0.6 mm hole drilled in the right side and placed on top of a beaker of a known mass. The water dripped into the beaker was measuring by weighing it. Every hour the mass was measured. Table 1 reveals the water height in MG11 and the beaker mass every hour. From this, an average flow rate of 0.59 ml/hour over the span of 6 hours was calculated. TABLE 1

[0093] Optional Disposable Reservoir: Besides keeping the cost low enough for daily use, other factors that are paramount include safety, ergonomics, and regulations. The reservoir may be permanently attached to the oral device; alternatively, the reservoir may be releasably attached to the oral device so that at least a portion of the reservoir can be detached, and the wick may be replaced. In addition, while the reservoir is depicted as being directly attached to a portion of the oral device, it will be understood that this depiction is for purposes of example only; the reservoir may also be external to the oral device. Either of these placements of reservoirs is methods as operable; for simplicity and illustrative purposes only, the reservoir is shown attached to the main lower body. Regardless of placement of characteristics of the reservoir, the design must be durable and airtight when in operation.

[0094] The volume of the reservoir should be large enough to supply waterthrough the night and small enough to be comfortable and safe in the mouth. In the case of the disposable reservoir and after repeated uses, the reservoir must be easy to connect and disconnect, have an unbreakable fitting when connected, and have no potential leaks.

NON-LIMITING ILLUSTRATIVE EMBODIMENTS

[0095] Illustrative embodiment 1. An oral device configured for delivery of a liquid to the mouth of the subject, the oral device comprising: a base component having a substantially U- shape to generally correspond to a dental arch of the subject, the base component comprising a reservoir extending from an upper surface thereof and configured for receiving a volume of liquid, the reservoir comprising a wicking agent disposed therein that dispenses liquid via capillary action, at least one opening formed in a sidewall thereof for filling the reservoir with liquid, and at least one opening formed in a surface thereof for delivery of the liquid to the subject.

[0096] Illustrative embodiment 2. The oral device of Illustrative embodiment 1, further comprising an upper component which frictionally engages with the base component, the upper component having an upper surface, a lower surface, a flange extending substantially perpendicularly from at least a portion of an outer edge of the upper surface, wherein the upper component is configured to engage at least a portion of the upper teeth of the subject, and wherein the engagement of the upper component with the base component seals the at least one opening formed in the sidewall of the base component, thereby retaining liquid in the reservoir so that it is dispensed at a controlled rate through the at least one opening in the lower end of the base component.

[0097] Illustrative embodiment 3. The oral device of Illustrative embodiment 1 or 2, wherein the base component has an upper surface, a lower surface, an outer flange extending substantially perpendicularly from at least a portion of an outer edge (such as, but not limited to, a front outer edge) of the upper surface, and a groove formed between the outer flange and the reservoir, and wherein the upper component frictional ly engages with the groove of the base component.

[0098] Illustrative embodiment 4. The oral device of any of Illustrative embodiments 1-3, wherein the upper component further comprises a back flange extending substantially from at least a portion of a back outer edge of the upper surface thereof, wherein the back flange engages the at least one opening in the sidewall of the reservoir to seal the liquid within the reservoir.

[099] Illustrative embodiment 5. The oral device of any of Illustrative embodiments 1-4, wherein at least a portion of the upper component is formed of a heat-moldable polymer material that can substantially conform to the subject's upper teeth upon heating.

[0100] Illustrative embodiment 6. The oral device of any of Illustrative embodiments 1-5, wherein the base component is formed of a material selected from the group consisting of ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene and methyl acrylate copolymer, latex rubber, medical grade silicone rubber, liquid silicone rubber (LSR), acrylic resin, vinyl resin, and combinations, laminations, and copolymers thereof.

[0101] Illustrative embodiment 7. The oral device of any of Illustrative embodiments 1-6, wherein the oral device is reusable.

[0102] Illustrative embodiment 8. The oral device of any of Illustrative embodiments 1-7, wherein at least a portion of the reservoir is releasably attached to the base component.

[0103] Illustrative embodiment 9. The oral device of Illustrative embodiment 8, wherein at least a portion of an upper portion of the reservoir is detachable from the base component to thereby allow for removal and replacement of the wicking agent.

[0104] Illustrative embodiment 10. The oral device of any of Illustrative embodiments 1-9, wherein the upper component is formed of a material selected from the group consisting of ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polyvinyl chloride (PVC), a copolymer of vinyl acetate or ethylene, and combinations, laminations, and copolymers thereof.

[0105] Illustrative embodiment 11. The oral device of any of Illustrative embodiments 1-10, wherein the wicking agent is formed of a material selected from the group consisting of cotton, silk, cellulose, porous ceramic, and combinations and laminations thereof.

[0106] Illustrative embodiment 12. The oral device of any of Illustrative embodiments 1-1, wherein the reservoir is shaped and sized to hold a volume of liquid in a range of from about 5 ml to about 150 ml.

[0107] Illustrative embodiment 13. The oral device of any of Illustrative embodiments 1-12, wherein the wick has a controlled release rate in a range of from about 0.5 ml/hr to about 30 ml/hr.

[0108] Illustrative embodiment 14. The oral device of any of Illustrative embodiments 1-13, wherein the base and/or upper component is formed by a method selected from the group consisting of thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and combinations thereof.

[0109] Illustrative embodiment 15. The oral device of any of Illustrative embodiments 1-14, wherein the at least one opening in the lower surface of the reservoir in the base component for delivery of liquid to the subject is produced by a method selected from the group consisting of drilling, laser drilling, thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and combinations thereof.

[0110] Illustrative embodiment 16. The oral device of any of Illustrative embodiments 1-15, wherein the least one opening for delivery of liquid is in a lower surface thereof.

[0111] Illustrative embodiment 17. The oral device of any of Illustrative embodiments 1-16, wherein the least one opening for delivery of liquid is in a sidewall thereof.

[0112] Illustrative embodiment 18. The oral device of any of Illustrative embodiments 1-17, wherein the least one opening for delivery of liquid is in a lower surface and sidewall thereof.

[0113] Illustrative embodiment 19. The oral device of any of Illustrative embodiments 1-18, wherein the at least one opening for delivery of liquid has a diameter in a range of from about 50 nm to about 5 mm.

[0114] Illustrative embodiment 19A. The oral device of any of Illustrative embodiments 1- 18, wherein the at least one opening for delivery of liquid has an area in a range of from about 0.2 mm² to about 4 mm².

[0115] Illustrative embodiment 20. The oral device of any of Illustrative embodiments 1-19, wherein the at least one opening for delivery of liquid formed in the base component comprises a plurality of openings.

[0116] Illustrative embodiment 21. A kit, comprising two or more of oral devices, wherein each oral device is selected from an oral device of any of Illustrative embodiments 1-20.

[0117] Illustrative embodiment 22. A system, comprising two or more of oral devices, wherein each oral device is selected from an oral device of any of Illustrative embodiments 1- 20.

[0118] Illustrative embodiment 23. A method of producing an oral device, comprising the steps of: producing the base component of the oral device of any of Illustrative embodiments 1- 20; optionally producing the upper component of the oral device of any of Illustrative embodiments 1-20; optionally adding at least one opening to the base component; optionally releasably attaching the upper component to the base component; and sterilizing the oral device.

[0119] Illustrative embodiment 24. The method of Illustrative embodiment 23, wherein at least one of the base component and the optional upper component is produced by a production method selected from the group consisting of thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and combinations thereof.

[0120] Illustrative embodiment 25. The method of Illustrative embodiment 23 or 24, wherein the at least one opening for receiving liquid into the reservoir and/or the at least one opening for dispensing liquid from the reservoir is added post-processing by a method selected from drilling and laser drilling.

[0121] Illustrative embodiment 26. A method, comprising the steps of: (i) disposing liquid in the reservoir of the base component of the oral device of any of Illustrative embodiments 1-20; (ii) sealing the liquid in the reservoir; (iii) disposing at least a portion of the oral device containing the reservoir within an oral cavity of a subject; and (iv) retaining the oral device within the oral cavity of the subject for a period of time so that at least a portion of the liquid in the reservoir is delivered at a controlled rate to the oral cavity of the subject.

[0122] Illustrative embodiment 27. The method of Illustrative embodiment 26, wherein step (ii) is further defined as attaching the upper component of the oral device to the base component, thereby sealing the liquid in the reservoir.

[0123] Illustrative embodiment 28. The method of Illustrative embodiment 26 or 27, wherein the liquid is selected from the group consisting of water, an oral solution or rinse, an electrolyte containing solution, a nutritional composition, a supplement composition, a prescription medication, an over-the-counter medication, and combinations thereof.

[0124] Illustrative embodiment 29. The method of Illustrative embodiment 28, wherein the liquid is water.

[0125] Illustrative embodiment 30. The method of any of Illustrative embodiments 26-29, further defined as a method of treating xerostomia.

[0126] Illustrative embodiment 31. The method of any of Illustrative embodiments 26-30, wherein prior to step (i), the method further comprises the steps of: heating the upper component of the oral device to a temperature at which at least a portion of the material from which the upper component of the device is formed is moldable; and disposing the upper component of the oral device within the mouth of the subject so that at least a portion of the upper component is molded to specifically conform to at least a portion of the upper teeth of the subject.

[0127] Illustrative embodiment 32. The method of any of Illustrative embodiments 26-31, wherein prior to step (i), the method further comprises the step of selecting the oral device from a plurality of oral devices having different sizes.

[0128] Illustrative embodiment 33. The method of any of Illustrative embodiments 26-32, wherein the method further comprises the steps of: (v) removing the oral device from the cavity of the subject; and (vi) repeating steps (i)-(v) one or more times.

[0129] Thus, in accordance with the present disclosure, there have been provided devices, kits, and assemblies, as well as methods of producing and using same, which fully satisfy the objectives and advantages set forth herein. Although the present disclosure has been described in conjunction with the specific drawings, experimentation, results, and language set forth hereinabove, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the present disclosure.

Claims

1. An oral device configured for delivery of a liquid to a mouth of a subject, the oral device comprising: a base component having a substantially U-shape to generally correspond to a dental arch of the subject, the base component comprising a reservoir extending from an upper surface thereof and configured for receiving a volume of liquid, the reservoir comprising a wicking agent disposed therein that dispenses liquid via capillary action, at least one opening formed in a sidewall thereof for filling the reservoir with liquid, and at least one opening formed in a surface thereof for delivery of the liquid to the subject.

2. The oral device of claim 1, further comprising an upper component which frictionally engages with the base component, the upper component having an upper surface, a lower surface, a front flange extending substantially perpendicularly from at least a portion of an outer edge of the upper surface, wherein the upper component is configured to engage at least a portion of the upper teeth of the subject, and wherein the engagement of the upper component with the base component seals the at least one opening formed in the sidewall of the base component, thereby retaining liquid in the reservoir so that it is dispensed at a controlled rate through the at least one opening in the lower end of the base component.

3. The oral device of claim 2, wherein the base component has an upper surface, a lower surface, an outer flange extending substantially perpendicularly from at least a portion of an outer edge of the upper surface, and a groove formed between the outer flange and the reservoir, and wherein the upper component frictionally engages with the groove of the base component.

4. The oral device of claim 2, wherein the upper component further comprises a back flange extending substantially from at least a portion of a back outer edge of the upper surface thereof, wherein at least a portion of the back flange engages the at least one opening in the sidewall of the reservoir to seal the liquid within the reservoir.

5. The oral device of claim 2, wherein at least a portion of the upper component is formed of a heat-moldable polymer material that can substantially conform to the subject's upper teeth upon heating.

6. The oral device of claim 2, wherein the upper component is formed of a material selected from the group consisting of ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polyvinyl chloride (PVC), a co-polymer of vinyl acetate or ethylene, and combinations, laminations, and copolymers thereof.

7. The oral device of claim 1, wherein the base component is formed of a material selected from the group consisting of ethylene vinyl acetate (EVA), polyvinyl acetate (PVA), polyvinylchloride (PVC), polyethylene, polyurethane, polylactic acid (PLA), thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene and methyl acrylate copolymer, latex rubber, medical grade silicone rubber, liquid silicone rubber (LSR), acrylic resin, vinyl resin, and combinations, laminations, and copolymers thereof.

8. The oral device of claim 1, wherein the wicking agent is formed of a material selected from the group consisting of cotton, silk, cellulose, porous ceramic, and combinations and laminations thereof.

9. The oral device of claim 1, wherein the reservoir is shaped and sized to hold a volume of liquid in a range of from about 5 ml to about 150 ml.

10. The oral device of claim 1, wherein the wick has a controlled release rate in a range of from about 0.5 ml/hr to about 30 ml/hr.

11. The oral device of claim 2, wherein the base and/or upper component is formed by a method selected from the group consisting of thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and combinations thereof.

12. The oral device of claim 1, wherein the at least one opening in the lower surface of the reservoir in the base component for delivery of liquid to the subject is produced by a method selected from the group consisting of drilling, laser drilling, thermoforming, injection molding, blow molding, 3D printing, ultrasonic welding, and combinations thereof.

13. The oral device of claim 1, wherein the least one opening for delivery of liquid is in a lower surface thereof.

14. The oral device of claim 1, wherein the at least one opening for delivery of liquid is in a sidewall thereof.

15. The oral device of claim 1, wherein the at least one opening for delivery of liquid has a diameter in a range of from about 50 nm to about 5 mm.

16. The oral device of claim 1, wherein the at least one opening for delivery of liquid formed in the base component comprises a plurality of openings.

17. The oral device of claim 1, wherein the oral device is reusable.

18. A kit, comprising two or more of the oral devices of any one of claims 1-17.

19. A system, comprising two or more of the oral devices of any one of claims 1-17.

20. A method, comprising the steps of:

(i) disposing liquid in the reservoir of the base component of the oral device of any one of claims 1-17;

(ii) sealing the liquid in the reservoir; and

(iii) disposing at least a portion of the oral device containing the reservoir within an oral cavity of a subject; and

(iv) retaining the oral device within the oral cavity of the subject for a period of time so that at least a portion of the liquid in the reservoir is delivered at a controlled rate to the oral cavity of the subject.

21. The method of claim 20, wherein step (ii) is further defined as attaching the upper component of the oral device to the base component, thereby sealing the liquid in the reservoir.

22. The method of claim 20, wherein the liquid is selected from the group consisting of water, an oral solution or rinse, an electrolyte containing solution, a nutritional composition, a supplement composition, a prescription medication, an over-the-counter medication, and combinations thereof.

23. The method of claim 22, wherein the liquid is water.

24. The method of claim 20, further defined as a method of treating xerostomia.

25. The method of claim 20, wherein priorto step (i), the method further comprises the steps of: heating the upper component of the oral device to a temperature at which at least a portion of the material from which the upper component of the device is formed is moldable; and disposing the upper component of the oral device within the mouth of the subject so that at least a portion of the upper component is molded to specifically conform to at least a portion of the upper teeth of the subject.

26. The method of claim 20, wherein prior to step (i), the method further comprises the step of selecting the oral device from a plurality of oral devices having different sizes.

27. The method of claim 20, wherein the method further comprises the steps of:

(v) removing the oral device from the cavity of the subject; and

(vi) repeating steps (i)-(v) one or more times.