Oral instruments and methods for treating sleep disorders

Abstract

An oral appliance and method for treating a sleep disorder in a subject is disclosed. The appliance includes, among other elements, a palate overlay element that engages a portion of the dorsal surface of the subject's tongue and stabilizes the tongue in an upward direction toward the hard palate. The method generally involves stabilizing the dorsal surface of the subject's tongue in an upward direction toward the subject's hard palate.

Description

Technical Field

[0001] This application generally relates to oral appliances and methods for treating sleep disorders in a subject by stabilizing the tongue in an upward direction toward the hard palate of the subject.

[0002] Cross - reference to related applications This application claims the benefit and priority of the filing date of U.S. Provisional Application No. 63 / 040,700, filed on June 18, 2020, the entire disclosure of which is incorporated herein by reference.

Background Art

[0003] Various sleep disorders are associated with the physiological functions of the mouth. As an example, there is obstructive sleep apnea (OSA), which is a common, under - diagnosed disorder that causes repeated closure of the back of the throat. OSA interferes with breathing, leading to sleep deprivation and stress on the body. This disorder is associated with daytime sleepiness, reduced cognitive function, irregular heartbeat, high blood pressure, stroke, and early death. When the muscle tone of the throat muscles decreases during sleep, closure of the back of the throat occurs. This typically happens when the tongue slides backward and blocks the airflow through the nose and mouth.

[0004] A common treatment for OSA is the use of a continuous positive airway pressure (CPAP) device. The CPAP device keeps the patient's airway open during sleep by forcing air through a snug mask that covers the mouth and / or nose. For many patients, the CPAP device is uncomfortable and difficult to handle, presenting a significant change to the normal sleep environment. As a result, 50% of OSA patients reject CPAP treatment, and 30% of patients cannot tolerate it. For OSA patients who cannot tolerate CPAP treatment or who have difficulty consistently using it, breathing - obstruction - free sleep is difficult.

[0005] Various intraoral prostheses are also used in the treatment of OSA. Two common prostheses are mandibular anterior fixation devices (MADs) and tongue retention devices (TRDs). MADs are designed to mechanically move the entire jaw forward, while TRDs pull the tongue out of the mouth. However, like CPAP devices, MADs and TRDs can worsen symptoms. These devices can also cause persistent jaw and tongue pain, and even tooth or facial deformities.

[0006] Currently, there is no effective treatment that the majority of OSA patients can consistently tolerate. Therefore, there is a need for alternative therapies that allow OSA patients to breathe without obstruction and minimize discomfort and sleep disturbances. This need, and others, can be met by the oral devices and methods described below. [Overview of the project]

[0007] In one embodiment of this specification, an oral appliance for treating sleep disorders in a subject is disclosed. The oral appliance may comprise a U-shaped element, a palatal overlay element, and a port configured to apply negative pressure to the appliance so that, during use, the appliance can stabilize the subject's tongue by engaging the tongue upward toward the subject's hard palate.

[0008] The U-shaped element may have an outer side wall, an inner side wall, and at least one occlusal surface, which together define at least one channel configured to receive at least one upper tooth of the subject.

[0009] The palatal overlay element may be configured to be adjacent to the U-shaped element and to fit at least a portion of the hard palate of the object. The palatal overlay element may have an inner surface and an outer surface, and a plurality of perforations (e.g., openings) extending through the palatal overlay element may be defined between the inner and outer surfaces. The plurality of perforations may be oriented downward along the longitudinal axis of the object.

[0010] The ports may be configured to communicate fluidly with multiple perforations in the palatal overlay element and to provide negative pressure to the multiple perforations in the palatal overlay element.

[0011] The outer surface of the palatal overlay element may be configured to engage with at least a portion of the posterior surface of the tongue of the subject in response to the application of negative pressure through multiple perforations in the palatal overlay element.

[0012] This specification also discloses, in another embodiment, a method for treating sleep disorders in a subject. The method may include, for example, stabilizing the subject's tongue upward toward at least a portion of the subject's hard palate by applying negative pressure or by an adhesive mechanism such as a moisture-resistant adhesive. Oral instruments may be used to carry out the method in various embodiments, but the method is not limited to any particular device or instrument.

[0013] Additional advantages of the disclosed apparatus and methods are, in part, described in the following description, and in part, can be understood from the description or learned through practice of the disclosed oral apparatus and methods. The advantages of the disclosed apparatus and methods will be realized and achieved by the elements and combinations specifically indicated in the attached claims. It should be understood that both the above summary and the following modes for carrying out the invention are merely illustrative and descriptive and do not limit the claimed invention.

[0014] The accompanying figures incorporated herein and constituting part thereof illustrate several embodiments of the disclosed oral instruments and methods and, together with the description, serve to illustrate the principles of the disclosed instruments and methods. [Brief explanation of the drawing]

[0015] [Figure 1] This figure shows an embodiment of an oral appliance in which multiple perforations and fluid-communicating ports are positioned near the anterior region of the oral appliance. [Figure 2]This figure shows an embodiment of an oral device in which multiple perforations and fluid-communicating ports are positioned near the posterior region of the oral device. [Figure 3] This figure shows a subject using an embodiment of an oral appliance during sleep. [Modes for carrying out the invention]

[0016] The disclosed oral instruments and methods can be more readily understood by referring to the following detailed description of specific embodiments and the examples contained herein, as well as the figures and their preceding and succeeding descriptions.

[0017] A.Definition It should be understood that the terms used herein are solely for the purpose of describing specific embodiments and are not intended to limit the scope of the invention, which is limited only by the appended claims.

[0018] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless otherwise clearly indicated in the context. Thus, for example, a reference to “a port” includes multiple such ports, and a reference to “the port” refers to one or more ports and their equivalents that are known to those skilled in the art.

[0019] "Optional" or "optional" means that the event, situation, or material described thereafter may or may not occur or exist, and that the description includes both instances where the event, situation, or material occurs or exists, and instances where it does not occur or exist.

[0020] A range may be expressed as "approximately" from one specific value and / or "approximately" from another specific value. Where such a range is expressed, the range from one specific value and / or the other is also considered specifically intended and disclosed, unless otherwise specifically indicated in the context. Similarly, where a value is expressed as an approximation, the use of the antecedent "approximately" implies that the specific value forms another specifically intended embodiment, and is considered disclosed, unless otherwise specifically indicated in the context. Furthermore, each endpoint of a range is significant, both in relation to other endpoints and independently of other endpoints, unless otherwise specifically indicated in the context. Finally, it should be understood that all individual values ​​and sub-ranges of values ​​encompassed within an explicitly disclosed range should also be considered specifically intended and disclosed, unless otherwise specifically indicated in the context. The above applies in any particular case, whether some or all of these embodiments are explicitly disclosed.

[0021] If, at the discretion of the parties, in some embodiments, a value is approximated by the use of the antecedent “about,” “substantially,” or “generally,” then a value up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of a particular stated value or characteristic may be included within the range of these embodiments.

[0022] As used herein, the term “hard palate” refers to the thin bony plate, composed of facial bone, located within the maxilla of the oral cavity of the subject, closest to the opening of the mouth. The hard palate is distinguished from the “soft palate” in that it contains no bone and is rather a fleshy region at the back of the oral cavity of the subject, ending at the uvula (the fleshy extension at the back of the oral cavity that extends into the throat).

[0023] As used herein, the term “molar” refers to the maxillary (upper) molars, including the maxillary first molar, maxillary second molar, and maxillary third molar (also known as the wisdom tooth). Molars have four or five apex points.

[0024] As used herein, the term "incisors" refers to the maxillary (upper jaw) incisors, including the two maxillary central incisors (closest to the center of the mouth) and the two maxillary lateral incisors (beside the maxillary central incisors).

[0025] As used herein, the term "thermoplastic material" refers to a polymeric material that is flexible or moldable at a certain elevated temperature and solidifies upon cooling.

[0026] The term "silicone" as used herein refers to a polymeric material that includes any compound consisting of repeating units of siloxane, in which silicon atoms and oxygen atoms alternate and are bonded in chains with carbon, hydrogen, and optionally other elements.

[0027] The term "acrylic" as used herein refers to a glassy thermoplastic polymeric material made from acrylic acid.

[0028] As used herein, the term "adhesive polymer" refers to any polymeric material that is slightly adhesive or tacky at room temperature or near room temperature.

[0029] As used herein, "a condition associated with the physiological functions of the mouth" means any condition that causes sleep disorders accompanied by various tissue and bone displacements or misalignments present in the oral and pharyngeal cavities. Non-limiting examples include obstructive sleep apnea, mouth breathing, snoring, teeth grinding, dry mouth, bad breath, excessive salivation, tardive dyskinesia, and the like.

[0030] As used herein, "conforming to" is to be understood to mean either (a) being deformed to fit the shape of the described surface or structure, or (b) having a complementary shape to the described surface or structure.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in the field to which the disclosed apparatus and methods belong. Any oral apparatus and methods similar or equivalent to those described herein may be used in the implementation or testing of the apparatus and methods, but those described herein are particularly useful.

[0032] Throughout this specification and the claims, the phrase “comprise,” and variations thereof such as “comprising” and “comprise,” mean “including, but not limited to,” and are not intended to exclude, for example, other elements, components, integers, or steps. In particular, where a method is described as including one or more steps or actions, each step is specifically intended to include those listed (unless the step includes a limiting term such as “consisting of”), and each step is not intended to exclude, for example, other elements, components, integers, or steps not listed in the step.

[0033] B.Oral appliances Disclosed herein are oral devices for treating sleep disorders in subjects (e.g., humans), the oral devices may include, among other elements, a palatal overlay element through which suction (negative pressure) can be applied, so that the palatal element engages with the dorsal surface of the subject's tongue to stabilize the tongue upward toward the hard palate. In one embodiment, the oral device is designed to be custom-fit to the individual subject and can prevent throat obstruction and airway obstruction during sleep using gentle suction applied through the palatal element.

[0034] Referring to Figures 1 and 2, the oral appliance 100 may have a U-shaped element 110, a palatal overlay element 120, and a port 130 to which suction (negative pressure) can be applied. The U-shaped element 110 may comprise an outer side wall 112, an inner side wall 114, and at least one occlusal surface 116. Together, the outer side wall 112, the inner side wall 114, and at least one occlusal surface 116 define a channel 118 configured to receive at least one maxillary tooth of the subject. In one embodiment, the channel 118 is configured to receive most or all of the maxillary tooth of the subject. Such a configuration can be fabricated, for example, from a mold of the subject's maxillary tooth based on an optical image obtained from scanning the oral cavity of the subject, or through other methods known in the art.

[0035] In further embodiments, the oral appliance may have any preferred shape such that the appliance fits into the oral cavity of the subject. In one embodiment, for example, the oral appliance may be molded to provide a fit with at least a portion of the hard palate of the subject. An appliance of any preferred shape and form may form a non-permanent attachment between the dorsal surface of the subject's tongue and the hard palate of the subject, and may stabilize the tongue in an upward direction toward the hard palate.

[0036] Referring again to Figures 1 and 2, the palatal overlay element 120 may be adjacent to the U-shaped element 110. For example, in some optional embodiments, the palatal overlay element may extend around the inner side wall 114 of the U-shaped element and between opposing portions. Thus, in some optional embodiments, the palatal overlay element 120 and the U-shaped element 110 may intersect at a continuous interface extending along the entire inner wall 114, or substantially along the entire inner wall 114. In one embodiment, the palatal overlay element 120 and the U-shaped element 110 may be monolithic or a single structure. In other embodiments, the palatal overlay element 120 and the U-shaped element 110 may be continuous but not monolithic. That is, the palatal overlay element 120 and the U-shaped element 110 may be fabricated separately and combined or formed into a composite material or assembly.

[0037] The palatal overlay element 120 may comprise an inner surface 122 facing the hard palate of the object and an opposing outer surface 124 facing the tongue of the object. The inner surface 122 may define one or more hollow chambers 125 to which suction (negative pressure) can be applied. Optionally, during use of an oral instrument 100 as further disclosed herein, the one or more hollow chambers 125 defined by the inner surface 122 of the palatal overlay element 120 may be further partially defined by the hard palate of the object. Specifically, according to one embodiment, negative pressure can be applied to the posterior surface of the tongue of the object through a plurality of perforations (e.g., openings) 126 extending through the palatal overlay element 120 between the inner surface 122 and the outer surface 124. The plurality of perforations 126 may be oriented downward along the longitudinal axis of the object. Thus, in one embodiment, the plurality of perforations 126 may be oriented so that the perforations engage with the posterior surface of the tongue of the object when negative pressure is applied through the palatal overlay element 120.

[0038] In one embodiment, the multiple perforations 126 can be designed to allow gentle suction (negative pressure) on the dorsal surface of the tongue at different locations on the tongue surface, minimizing irritation or injury to any part of the tongue during use. Thus, in some embodiments, the number of perforations in the multiple perforations 120 can depend on variables such as the surface area of ​​the hard palate of the target, the weight of the tongue, and the amount of negative pressure required to engage with the tongue and pull it upward toward the hard palate. In the exemplary embodiments shown in Figures 1 and 2, the multiple perforations 126 include six perforations. In other embodiments, the multiple perforations 126 may have more than two perforations. In further embodiments, the multiple perforations 126 may include 2 to 12 perforations. In further embodiments, the multiple perforations 126 may have 4 to 8 perforations, or 4 to 6 perforations. In some optional embodiments, the perforations may be circular, square, rectangular, elliptical, or any other preferred shape. In some optional embodiments, each of the perforations can define an area of ​​1 to 20 square millimeters (for example, arbitrarily, about 2 square millimeters or about 5 square millimeters) passing through it. In some optional embodiments, the perforations 126 can collectively define an area of ​​at least 8 square millimeters, at least 20 square millimeters, at least 40 square millimeters, or less than 100 square millimeters (i.e., the sum of all areas of the perforations 126) passing through it.

[0039] Optionally, as shown in Figures 1 and 2, multiple perforations 126 can be arranged as two spaced-apart clusters positioned on opposing lateral edges of the palatal overlay element. In exemplary embodiments, the number of perforations in each cluster can be equal. In other embodiments, the number of perforations in each cluster can be different. In further embodiments, the perforations in each cluster can be substantially equally spaced (measured from center point to center point) and move along each lateral edge of the palatal overlay element. Alternatively, the perforations in each cluster can be unequally spaced. In further exemplary embodiments, multiple perforations can include rows and / or columns of perforations extending across the width and / or length of the palatal overlay element. In these embodiments, equal or unequal spacing (from center point to center point) can be used within each row and / or column. Optionally, when rows are used, it is intended that the perforations in one row can be offset relative to the perforations in consecutive rows.

[0040] Port 130 can be in fluid communication with a plurality of perforations 126. In one embodiment, port 130 may be configured to provide suction (negative pressure) to a plurality of perforations 126 in the palatal overlay element 120. In exemplary embodiments, port 130 may include a conduit (e.g., one or more hollow chambers 125) extending between the port inlet / outlet and the palatal overlay element 120, or may be in fluid communication with the conduit.

[0041] In one embodiment, as shown in Figure 1, the port 130 may be positioned near the anterior (front) region 132 of the oral appliance 100. Therefore, for example, the port 130 may be positioned near the target incisors when the oral appliance 100 is inserted into the target oral cavity (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the aforementioned incisors). In the exemplary embodiment shown in Figure 1, the port 130 is positioned near the maxillary central incisors (the incisors closest to the center of the mouth) (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the aforementioned incisors). In other embodiments, the port 130 may be positioned near the maxillary lateral incisors (the incisors adjacent to the maxillary central incisors) (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the aforementioned incisors).

[0042] In another embodiment, as shown in Figure 2, the port 130 may be positioned in or near the posterior (rear) region 134 of the oral appliance 100. For example, the port 130 may be positioned near the molars of the subject when the oral appliance 100 is inserted into the subject's oral cavity (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the molars). In some embodiments, the port 130 may be positioned near the maxillary first molar, maxillary second molar, or maxillary third molar (also known as a wisdom tooth) when the oral appliance 100 is inserted into the subject's oral cavity (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the aforementioned teeth). In a further embodiment, the port 130 may be positioned near the subject's last maxillary molar, often the maxillary second molar in subjects that do not have one or more wisdom teeth (for example, the port 130 is located near the portion of the U-shaped element 110 configured to receive the aforementioned teeth). Such exemplary embodiments allow the subject to close their mouth when the oral instrument 100 is inserted into the oral cavity and connected to a negative pressure source through a tube.

[0043] As described herein, in some embodiments, “close to the tooth” may be understood to mean within approximately 3 cm, 2 cm, 1 cm, or 0.5 cm of the aforementioned tooth. Optionally, in some embodiments, the anterior region 132 and the posterior region 134 may be separated by a dashed line dividing the length of the oral appliance in half, with the anterior half (facing the front of the object) being the anterior region and the posterior half (facing the rear or back of the object) being the posterior region. In other optional embodiments, the anterior region 132 and the posterior region 134 may refer to the respective one-third of the oral appliance closest to the foremost or rearmost surface / edge of the appliance.

[0044] Referring to Figure 3, for example, the oral appliance 100 may include a negative pressure source 150 that is in fluid communication with the port 130. In one embodiment, the oral appliance 100 may include a tube 160 (e.g., any suitable conduit) that provides fluid communication between the negative pressure source 150 and the port 130, as shown in Figures 1 and 2. In some optional embodiments, at least one coupling element can connect the tube 160 to the port 130. For example, in some optional embodiments, the port 130 may define a first coupling element configured to connect to a second coupling element of the tube 160. The first and second coupling elements may optionally include, for example, complementary male and female threads, or other tube / hose connectors. In further embodiments, the port 130 may include a tube fitting (e.g., quick-replace or barbed connector) configured to receive the tube 160. In further embodiments, any suitable coupling element (e.g., barbed fitting) between the tube 160 and the port 130 is intended. In a further embodiment, the tube 160 may be integrally formed with the port 130. In one embodiment, the negative pressure source 150 may be a vacuum pump. In a further embodiment, the negative pressure source 150 may be a micropump, for example, a small pump of a few inches in length, or in some embodiments, an even smaller pump. Alternatively, the negative pressure source may be a syringe that can be manually operated by the subject by pulling or pushing (optionally, periodically) the plunger of the syringe to create a vacuum that can apply negative pressure to multiple perforations in the palatal overlay element.

[0045] In a further embodiment, the negative pressure source 150 may be configured to generate a suction pressure of at least -5 cmH2O. The negative pressure source 150 may be configured to generate a suction pressure of, for example, about -5 cmH2O to about -20 cmH2O, or in other embodiments, about -5 cmH2O to about -10 cmH2O. The amount of suction pressure that the negative pressure source 150 can be designed to provide may vary depending on the application. Thus, in some embodiments, the negative pressure source 150 may be configured to apply a gentle or comfortable level of suction to the dorsal surface of the tongue of the subject.

[0046] Tube 160 can be any suitable size tube formed from a material known in the art. According to one embodiment, tube 160 can have a diameter (e.g., outer diameter) in the millimeter range, for example, 1 to 5 mm, which may be a suitable size for use in a micropump. The length of tube 160 can also vary by the type of negative pressure source 150 and the location where the subject prefers to position the negative pressure source, for example, by attaching it to the subject's body or clothing, clipping it on, or placing it on a bedside table, etc. Optionally, tube 160 can be connected to a saliva pot or receptacle to capture any saliva drawn out of the oral cavity by the negative pressure source.

[0047] When used, the oral device may allow the tongue of the subject to be stabilized in an upward direction toward at least a portion of the subject's hard palate. A negative pressure source can transmit suction to the oral overlay element of the oral device through a tube. Suction can be applied to the dorsal surface of the tongue when transmitted through multiple perforations in the palatal overlay element. In some embodiments, for example, the oral device may allow the tongue to remain in a neutral position with respect to anterior-posterior movement within the oral cavity, preventing the tongue from protruding from the mouth during use. In various embodiments, the oral device may improve airway patency and nasal breathing during sleep. Stabilizing the tongue in an upward direction toward the hard palate may also treat or alleviate symptoms associated with various sleep disorders involving oral physiological functions, including but not limited to obstructive sleep apnea, mouth breathing, snoring, teeth grinding, dry mouth, bad breath, excessive salivation, and tardive dyskinesia.

[0048] In one embodiment, oral appliances, U-shaped elements, and / or oral overlay elements may include or be formed from any material suitable for insertion into the oral cavity of the subject. The material selected for the oral appliance may be chosen to maximize the comfort of the subject's oral cavity. Similarly, the material may be selected to provide non-permanent attachment (e.g., through an adhesive mechanism) of at least a portion of the oral appliance to the dorsal surface of the subject's tongue. Non-limiting examples of suitable materials include, but are not limited to, a variety of thermoplastics, silicones, acrylics, biocompatible materials (e.g., Formlabs, RS-F2-DLCL-01), adhesive polymers (which may help facilitate engagement of the palatal overlay element with the tongue), or combinations thereof. Adhesive polymers may include nano- or macro-sized architectural features, such as biomimetic wet / dry adhesive materials, which can facilitate the adhesion of the tongue to the palatal overlay element and provide a mechanism for manipulating the tongue muscles to hold it in place while the subject is sleeping.

[0049] In one embodiment, for example, at least a portion of an oral appliance, such as a palatal overlay element, may be formed from or include a moisture-tolerant adhesive on at least a portion of its surface. An example may be the adhesive described in Baik, S., Kim, D., Park, Y. et al., "A wet-tolerant adhesive patch inspired by protuberances in suction cups of octopi," Nature 546, 396-400 (2017), the entire teaching on moisture-tolerant adhesives is incorporated herein by reference.

[0050] Similarly, other suitable moisture-resistant adhesives are discussed in Dirks, J.-H. & Federle, W. "Fluid-based adhesion in insects-principles and challenges" Soft Matter 7, 11047-11053 (2011), Xue, L., Kovalev, A., Eichler-Wolf, A., Steinhart, M. & Gorb, SN "Humidity-enhanced wet adhesion on insect-inspired fibrillar adhesive pads" Nat.Commun. 6, 6621 (2015), and Chen, Y., Shih, M.-C., Wu, M.-H., Yang, E.-C. & Chi, K.-J. "Underwater attachment using hairs: the functioning of spatula and sucker setae from male diving beetles" JRSoc.Interface This may include hierarchical mushroom-shaped or porous structures that promote attraction or capillary action, including those described in 11, 20140273 (2014) and Kovalev, AE, Varenberg, M. & Gorb, SN, "Wet versus dry adhesion of biomimetic mushroom-shaped microstructures," Soft Matter 8, 7560-7566 (2012), the entire teaching relating to moisture-resistant adhesives is incorporated herein by reference.

[0051] Other suitable moisture-resistant adhesives include those having a supramolecular structure containing nanoparticles, as described in Rose, S. et al. "Nanoparticle solutions as adhesives for gels and biological tissues," Nature 505, 382-385 (2014), the entire teaching on moisture-resistant adhesives which is incorporated herein by reference. In another aspect, moisture-resistant adhesives are described in Zhao, Q. et al. "Underwater contact adhesion and microarchitecture in polyelectrolyte complexes actuated by solvent exchange" Nat. Mater. 15, 407-412 (2016), Lee, S.-B., Gonzalez-Cabezas, C., Kim, K.-M., Kim, K.-N. & Kuroda, K. "Catechol functionalized synthetic polymer as a dental adhesive to contaminated dentin surface for a composite restoration" Biomacromolecules 16, 2265-2275 (2015), and White, JD & Wilker, JJ "Underwater bonding with charged polymer mimics of marine mussel adhesive proteins" Macromolecules As described in 44, 5085-5088 (2011), chemical-based attractants using various protein polymer electrolytes may be included, which, with reference to the teachings relating to moisture-resistant adhesives, are incorporated herein by reference in their entirety.

[0052] Therefore, according to one embodiment, the oral appliance is intended to be able to adhere to the posterior surface of the tongue of the subject without relying on externally applied negative pressure. For example, by using a moisture-resistant adhesive on at least a portion of the surface of the palatal overlay element, the palatal overlay element of the disclosed appliance can adhere to the posterior surface of the tongue of the subject, thereby stabilizing the tongue upward through a non-permanent attachment.

[0053] Oral instruments can be fabricated using various techniques. In one embodiment, alginate impressions of the target teeth and hard palate can be taken, and a stone model can be made from the impressions. For example, by taking alginate impressions of the upper and lower teeth, it is intended that the occlusal profile for the oral instrument can be modeled and generated to match the occlusal profile of the target. The dental impression can then be embedded in a stone model material (e.g., Perfect Cast, B017N286R6). A dental forming machine (e.g., Buffalo; 84500) can be used to limit holes or cracks in the stone model. The stone impression can be scanned using a three-dimensional scanner (e.g., iPhone® app Scandy-pro-3D scanner) to create an initial computer image that is exported as a stereolithography (STL) file. The STL file can then be imported into software known in the dental technology field, such as computer-aided design (CAD) software (e.g., Mimics Innovation Suite MIS 22). Subsequently, the initial computer design can be modified to incorporate various custom design elements of the palatal overlay element, including, for example, perforations, dental overlays for missing or chipped teeth, and the height of the upper part of the oral appliance relative to the palate. The custom oral appliance can then be 3D printed (e.g., Objet Connex 500 printer; Stratasys) and final modifications to the instrument can be made. A similar method can be used, instead of alginate impressions, to obtain a custom scan of the oral cavity in question using an intraoral scanner (e.g., 3Shape trios). The image can be projected as the initial computer design and modified to incorporate the design elements of the palatal overlay element.

[0054] Although described herein as a U-shaped element, element 110 is intended to have any shape that is complementary to at least a portion of the teeth in question and that stabilizes the palatal overlay element in a position suitable for functioning as disclosed herein. For example, element 110 may have a lateral (lateral) portion, while the anterior portion may be omitted, such that at least a portion of the anterior teeth in question are not received within element 110, while the remaining teeth in question are received within the lateral portion.

[0055] C. Methods for treating sleep disorders Methods for treating sleep disorders in subjects are also disclosed herein. In one embodiment, the method may include stabilizing the tongue upward toward at least a portion of the hard palate of the subject. For example, the tongue can be stabilized by applying negative pressure to the oral cavity of the subject in a direction generally perpendicular to at least a portion of the dorsal surface of the subject's tongue. In another embodiment, the tongue can be stabilized upward through non-permanent attachment of the dorsal surface of the tongue to an oral device, for example, an oral device having a moisture-resistant adhesive on at least a portion of its surface. The disclosed method may be carried out using the disclosed device, but it will be understood that the method is not limited to any particular device.

[0056] If the method involves applying negative pressure to the tongue, the location on the posterior surface of the tongue to which the negative pressure is applied can vary. In one embodiment, for example, the negative pressure may be applied to the oral cavity of the subject in a direction generally perpendicular to the central region of the tongue. In another embodiment, the negative pressure may be applied to the oral cavity of the subject in a direction generally perpendicular to the anterior region of the tongue, i.e., in a direction closer to the tip of the tongue and the opening of the mouth.

[0057] In one embodiment, the method may be useful for pulling and stabilizing the tongue upward toward the hard palate without substantially moving the tongue forward toward the anterior region of the oral cavity or backward toward the posterior region of the oral cavity. Thus, for example, the tongue of the subject can remain in the oral cavity while it is stabilized upward, for example, while negative pressure is applied, or while the tongue is non-permanently attached to an oral appliance through a mechanism such as a moisture-resistant adhesive. By stabilizing the tongue upward toward the hard palate, nasal breathing can be promoted, which may be useful in treating various sleep disorders involving oral physiological functions, including, for example, obstructive sleep apnea, mouth breathing, snoring, teeth grinding, dry mouth, bad breath, excessive salivation, and tardive dyskinesia.

[0058] In another embodiment, negative pressure can be applied to multiple locations on the dorsal surface of the tongue. By applying negative pressure to multiple locations on the tongue, gentle suction can be applied to the tongue at different points so as not to irritate or injure the tongue while the negative pressure is being applied.

[0059] The amount of negative pressure applied to the tongue of the target can vary. In one embodiment, for example, the applied negative pressure is at least about -5 cmH2O, e.g., about -5 cmH2O to about -20 cmH2O, or about -5 cmH2O to about -10 cmH2O.

[0060] The method is not limited to any specific device or instrument, but in one embodiment, the tongue of a subject can be stabilized upward through an oral instrument configured to engage with at least a portion of the posterior surface of the tongue of the subject, for example, in response to the application of negative pressure or through an adhesive mechanism such as a moisture-resistant adhesive. The oral instrument may, in one embodiment, be an embodiment of the oral instrument described above. For example, the oral instrument may fit at least one upper tooth of the subject, or most or all of the upper teeth. Similarly, the oral instrument may fit at least a portion of the hard palate of the subject.

[0061] D. Exemplary embodiments Taking into consideration the apparatus, methods, and variations thereof described herein, certain more detailed embodiments of the present invention are described below. However, these particularly enumerated embodiments should not be construed as having any restrictive effect on any different claims that encompass different or more general teachings set forth herein, nor should the “certain” embodiments be construed as being limited in any way other than the inherent meaning of the words used therein literally.

[0062] Embodiment 1: An oral appliance for treating sleep disorders in a subject, wherein the oral appliance comprises (a) a U-shaped element having an outer side wall, an inner side wall, and at least one occlusal surface, the outer side wall, the inner side wall, and at least one occlusal surface together defining at least one channel configured to receive at least one upper tooth of the subject, and (b) a palatal overlay element adjacent to the U-shaped element and configured to fit at least a portion of the hard palate of the subject, the palatal overlay element Oral appliance comprising: (c) a palatal overlay element having an inner surface and an outer surface, defining a plurality of perforations extending through the palatal overlay element between the inner surface and the outer surface; and a port having fluid communication with the plurality of perforations of the palatal overlay element, the port being configured to transmit negative pressure to the plurality of perforations of the palatal overlay element, wherein the outer surface of the palatal overlay element is configured to engage with at least a portion of the dorsal surface of the tongue of an object in response to the application of negative pressure through the plurality of perforations of the palatal overlay element.

[0063] Embodiment 2: The oral appliance according to Embodiment 1, wherein the U-shaped element and the palatal overlay element are monolithic.

[0064] Embodiment 3: The oral appliance according to Embodiment 1 or 2, wherein the U-shaped element and the palatal overlay element are formed in the shape of a mold taken from at least one upper tooth and at least a portion of the hard palate of the object.

[0065] Embodiment 4: An oral appliance according to any one of the prior embodiments, wherein the U-shaped element and / or palatal overlay element comprises a thermoplastic, silicone, acrylic, adhesive polymer, or a combination thereof.

[0066] Embodiment 5: An oral instrument according to any one of the preceding embodiments, wherein the number of perforations is greater than two.

[0067] Embodiment 6: An oral instrument according to any one of Embodiments 1 to 4, wherein the number of perforations is in the range of 2 to 24.

[0068] Embodiment 7: An oral instrument according to any one of Embodiments 1 to 4, wherein the number of perforations is in the range of 4 to 8.

[0069] Embodiment 8: An oral device according to any one of Embodiments 1 to 4, wherein the number of perforations is in the range of 4 to 6.

[0070] Embodiment 9: An oral device according to any one of Embodiments 1 to 4, wherein the number of perforations is six.

[0071] Embodiment 10: The oral appliance according to any one of the preceding embodiments, wherein the port is positioned near the posterior region of the oral appliance.

[0072] Embodiment 11: The oral appliance according to any one of Embodiments 1 to 9, wherein the port is positioned near the anterior region of the oral appliance.

[0073] Embodiment 12: The oral device according to any one of Embodiments 1 to 9, wherein the port is positioned near the target molar when the oral device is inserted into the target oral cavity.

[0074] Embodiment 13: The oral device according to any one of Embodiments 1 to 9, wherein the port is positioned near the target incisor when the oral device is inserted into the target oral cavity.

[0075] Embodiment 14: The oral appliance according to any one of the prior embodiments, further comprising a negative pressure source in fluid communication with a port.

[0076] Embodiment 15: An oral appliance according to any one of the prior embodiments, further comprising a tube that provides fluid communication between a negative pressure source and a port.

[0077] Embodiment 16: The oral appliance according to Embodiment 14 or 15, wherein the negative pressure source is a vacuum pump.

[0078] Embodiment 17: The oral device according to Embodiment 14 or 15, wherein the negative pressure source is a micropump.

[0079] Embodiment 18: The oral appliance according to any one of embodiments 14 to 17, wherein the negative pressure source is configured to generate a pressure of at least about -5 cmH2O.

[0080] Embodiment 19: An oral appliance according to any one of Embodiments 14 to 17, wherein the negative pressure source is configured to generate a pressure of approximately -5 cmH2O to approximately -20 cmH2O.

[0081] Embodiment 20: The oral appliance according to any one of Embodiments 14 to 17, wherein the negative pressure source is configured to generate a pressure of approximately -5 cmH2O to approximately -10 cmH2O.

[0082] Embodiment 21: A method for treating a sleep disorder in a subject (for example, a sleep disorder associated with the physiological function of the mouth, such as obstructive sleep apnea, mouth breathing, snoring, teeth grinding, dry mouth, bad breath, excessive salivation, or tardive dyskinesia), comprising stabilizing the tongue upward toward at least a portion of the hard palate of the subject.

[0083] Embodiment 22: The method according to Embodiment 21, comprising forming a non-permanent attachment of a tongue to the surface of an oral appliance, wherein the surface of the oral appliance comprises a moisture-resistant adhesive.

[0084] Embodiment 23: The method according to Embodiment 21, comprising applying negative pressure to the oral cavity of a target in a direction generally perpendicular to at least a portion of the dorsal surface of the target tongue, thereby stabilizing the tongue in an upward direction.

[0085] Embodiment 24: The method according to Embodiment 23, wherein negative pressure is applied to the oral cavity of the target in a direction generally perpendicular to the central region of the dorsal surface of the target tongue.

[0086] Embodiment 25: The method according to Embodiment 23, wherein negative pressure is applied to the oral cavity of the target in a direction generally perpendicular to the anterior region of the dorsal surface of the target tongue.

[0087] Embodiment 26: The method according to any one of Embodiments 21 to 25, wherein the tongue of the target remains within the oral cavity of the target.

[0088] Embodiment 27: The method according to any one of Embodiments 23 to 26, wherein the applied negative pressure does not result in substantial backward movement of the tongue toward the back of the oral cavity of the subject.

[0089] Embodiment 28: The method according to any one of Embodiments 23 to 27, wherein the applied negative pressure promotes nasal breathing.

[0090] Embodiment 29: The method according to any one of Embodiments 23 to 28, wherein negative pressure is applied to multiple locations on the dorsal surface of the tongue of the subject.

[0091] Embodiment 30: The method according to any one of Embodiments 23 to 29, wherein the negative pressure applied to the target oral cavity is at least about -5 cmH2O.

[0092] Embodiment 31: The method according to any one of Embodiments 23 to 30, wherein the negative pressure applied to the target oral cavity is approximately -5 cmH2O to approximately -20 cmH2O.

[0093] Embodiment 32: The method according to any one of Embodiments 23 to 31, wherein the negative pressure applied to the target oral cavity is approximately -5 cmH2O to approximately -10 cmH2O.

[0094] Embodiment 33: The method according to any one of embodiments 23 to 32, wherein negative pressure is applied to the oral cavity of a target through an oral instrument configured to engage with at least a portion of the dorsal surface of the target's tongue in response to the application of negative pressure.

[0095] Embodiment 34: The method according to Embodiment 33, wherein the oral appliance is fitted to at least one upper tooth of the subject.

[0096] Embodiment 35: The method according to Embodiment 33 or 34, wherein the oral appliance is fitted to at least a portion of the hard palate of the subject.

[0097] Embodiment 36: The method according to any one of Embodiments 23 to 35, wherein negative pressure is applied to the target oral cavity through an oral instrument described in any one of Embodiments 1 to 20.

[0098] Those skilled in the art will be able to recognize or confirm many equivalents to the specific embodiments of the apparatus and methods described herein by means of routine experiments. Such equivalents are intended to be covered by the following claims.

Claims

1. An oral device for treating sleep disorders in a subject, wherein the oral device is a) A U-shaped element having an outer side wall, an inner side wall, and at least one occlusal surface, wherein the outer side wall, the inner side wall, and the at least one occlusal surface together define at least one channel configured to receive at least one upper tooth of the object, b) A palatal overlay element adjacent to the U-shaped element and configured to fit at least a portion of the hard palate of the object, wherein the palatal overlay element has an inner surface and an outer surface, defining a plurality of perforations extending through the palatal overlay element between the inner surface and the outer surface, and the U-shaped element and the palatal overlay element are formed in the shape of a mold taken from at least one upper tooth of the object and at least a portion of the hard palate of the object, such that the U-shaped element has the occlusal profile of the object, and the U-shaped element and the palatal overlay element are respective parts of a monolithic body, c) A port that is in fluid communication with the plurality of perforations of the palatal overlay element, wherein the port is configured to transmit negative pressure to the plurality of perforations of the palatal overlay element, An oral appliance wherein the outer surface of the palatal overlay element is configured to engage with at least a portion of the dorsal surface of the tongue of the object in response to the application of negative pressure through the plurality of perforations of the palatal overlay element.

2. The oral appliance according to claim 1, wherein at least one of the U-shaped element or the palatal overlay element comprises a thermoplastic, silicone, acrylic, adhesive polymer, moisture-resistant adhesive, or a combination thereof.

3. The oral appliance according to claim 1, wherein the number of perforations is greater than two.

4. The oral appliance according to claim 1, wherein the number of perforations is in the range of 2 to 24.

5. The oral appliance according to claim 1, wherein the number of perforations is in the range of 4 to 8.

6. The oral appliance according to claim 1, wherein the number of perforations is in the range of 4 to 6.

7. The oral appliance according to claim 1, wherein the number of perforations is six.

8. The oral appliance according to claim 1, wherein the port is positioned near the rear region of the oral appliance.

9. The oral appliance according to claim 1, wherein the port is positioned near the anterior region of the oral appliance.

10. The oral device according to claim 1, wherein the port is positioned near the molars of the target when the oral device is inserted into the oral cavity of the target.

11. The oral appliance according to claim 1, wherein the port is positioned near the incisors of the target when the oral appliance is inserted into the oral cavity of the target.

12. The oral appliance according to claim 1, further comprising a negative pressure source that is in fluid communication with the port.

13. The oral appliance according to claim 12, further comprising a tube that provides fluid communication between the negative pressure source and the port.

14. The oral appliance according to claim 12, wherein the negative pressure source is a vacuum pump.

15. The oral appliance according to claim 12, wherein the negative pressure source is a micropump.

16. The negative pressure source is at least about -5 cmH 2 The oral appliance according to claim 12, configured to generate pressure O.

17. The aforementioned negative pressure source is approximately -5 cmH 2 O ~ approx. -20cmH 2 The oral appliance according to claim 12, configured to generate pressure O.

18. The aforementioned negative pressure source is approximately -5 cmH 2 O ~ about -10cmH 2 The oral appliance according to claim 12, configured to generate pressure O.

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