Device and method for sleep apnea and snoring

Abstract

A mandibular advancement device (MAD) useful for treating snoring and obstructive sleep apnea (OSA) is disclosed. The improved MAD design consists of upper and lower splints that can be set in a highly protrusive position (as desired for snoring / OSA treatment) while still allowing some lateral mandibular movement. The amount of mandibular advancement is adjustable.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application is an international application under the Patent Cooperation Treaty, claiming the benefit and priority of U.S. Provisional Patent Application No. 62 / 966,797, filed on January 28, 2020, entitled "DEVICES AND METHODS FOR SLEEP APNEA AND SNORING", the content of which is incorporated herein by reference in its entirety.

[0002] Technical Field The present invention relates to devices and methods for the treatment of sleep apnea and snoring, particularly to devices and methods for mandibular adjustment, and more particularly to devices and methods related to an adjustable and / or customizable mechanism for positioning and holding upper and lower splints of a mandibular adjustment device.

Background Art

[0003] Snoring is a sound caused by the vibration of the soft tissues of a patient's upper airway, which is caused by breathing obstruction during sleep. There are many factors related to snoring, including, but not limited to, genetics, weight, age, gender, smoking history, tissue deformation, alcohol use, allergies, and sleep posture. Generally, the person who snores, and perhaps the sleep partner of the person who snores, suffers from sleep deprivation due to the snoring of the person who snores. Sleep deprivation can cause daytime fatigue, a weakened immune system, decreased mental and emotional health, irritability and lack of productivity, and other problems.

[0004] Obstructive sleep apnea (「OSA」) is a potentially life - threatening sleep and breathing disorder defined by the cessation of breathing for a certain period of time (10 seconds or more) and at a certain frequency. When breathing is interrupted, the body responds by waking up enough to start breathing again. OSA episodes occur hundreds of times every night, and although the person may not fully wake up, they remain unaware of the symptoms specific to OSA, such as loud snoring, choking, and shortness of breath. The health risks of OSA include high blood pressure, heart attack, stroke, daytime sleepiness, depression, fibromyalgia, irregular heartbeat, metabolic problems, short - term memory loss, weight gain, gastric reflux, high blood pressure, diabetes, severe anxiety, memory and concentration problems, morning headaches, cognitive decline, mood swings and shortness of breath, insomnia, risk and occurrence of impotence. Furthermore, many OSA patients are unable to get sufficient sleep due to repeated apnea events and awakenings that interfere with deep stages of sleep, which can lead to chronic daytime fatigue. An estimated 40 million Americans suffer from some degree of OSA, but only a small fraction of these are currently receiving any treatment.

[0005] Snoring and OSA are generally caused by the obstruction of the upper airway when various tissues, including the tongue, uvula, and soft palate, relax. Snoring is caused by a partial obstruction of breathing during sleep, while OSA occurs when the tongue and soft palate fall back into the back of the throat, completely blocking the upper airway, thereby stopping breathing and restricting the flow of oxygen.

[0006] There are many techniques for reducing or eliminating snoring and OSA. Various types of surgeries, including tracheotomy, surgeries on the soft palate and the oropharynx, and reconstructive surgeries, are utilized for the treatment of snoring and OSA. However, surgery is costly, risky, and not always effective. Respiratory therapies for the treatment of OSA are also used, and generally, a ventilation device type mask that supplies air / oxygen at a pressure higher than atmospheric pressure is worn by the patient, and is generally known as a continuous positive airway pressure system or a CPAP system. In this therapy, those that change the pressure, such as bilevel positive airway pressure (BiPAP) and multilevel positive airway pressure (MPAP), are also used. However, in these systems, since it is difficult for the patient to get used to the mask and its pressure, the patient compliance is significantly impaired. Also, these systems are noisy and may affect the patient's sleep partner, and in some cases, the patient and the sleep partner may even have to sleep in separate rooms in order to get effective sleep. That is, patients often dislike these types of respiratory therapies and thus discontinue use.

[0007] Another class of snoring / OSA solutions includes devices that the patient wears to reposition the patient's jaw to inhibit the airway from closing. Such devices are generally referred to as mandibular advancement devices (MAD) or mandibular advancement splints. The MAD treats snoring and OSA by slightly advancing the mandible (lower jaw) in a protruding direction (generally horizontal direction) relative to the maxilla (upper jaw). This causes the soft tissues of the upper airway to be tightened, preventing obstruction during sleep. Also, it suppresses the vibration of the soft tissues of the upper airway and the passage of air, reducing snoring. The MAD is generally more difficult to handle than respiratory therapy systems (CPAP, BiPAP, etc.) and can enhance patient compliance. The MAD is prescribed by various types of doctors, but since it is worn on the teeth, the MAD is generally manufactured and worn under the instructions of dentists, orthodontists, etc.

[0008] Summary of the Invention The present invention relates to an apparatus and method for the treatment of sleep apnea and snoring, and more particularly to an apparatus and method for adjusting the lower jaw, and more specifically to an apparatus and method for an adjustable and / or customizable mechanism for positioning and holding upper and lower splints of a mandibular advancement device (MAD).

[0009] Generally, a MAD device can include an upper splint and a lower splint for holding at least a portion of a person's upper jaw (maxilla) and lower jaw (mandible), respectively. The splints may generally be formed to conform to and contour a particular person's jaw, such as through the use of a dental impression, although standardized or off-the-shelf splints may also be utilized. The upper and lower splints can generally be operatively coupled together in an arrangement that promotes positioning of the lower splint in a generally forward position relative to the generally horizontal orientation of the upper splint and jaw, and thus the person's lower jaw.

[0010] In one aspect of the present invention, the MAD may include an adjustable mechanism that can vary the relative positioning of the upper and lower splints. The adjustable mechanism can generally set a relative horizontal difference between the upper and lower splints such that the lower splint can be set in a desired forward horizontal position relative to the upper splint, generally for treating apnea and / or snoring through a protruded positioning of the lower jaw. In some exemplary embodiments, the adjustable mechanism includes a rail portion attached to one splint and a corresponding groove portion attached to the other splint, and the rail portion and groove portion may be fitted or interact such that the rail portion can slide along (or vice versa) the groove portion to change the relative positioning of the upper and lower splints. The groove and rail portions may also be shaped such that the rail portion is retained within the groove portion, for example by using corresponding shapes (e.g., male-female connection), to prevent the upper and lower splints from separating during use.

[0011] In some embodiments, at least two sets of rail and groove portions may be included to connect the upper and lower sprints. For example, one set may be present on each of the left and right sides of the jaw. The rail and groove portions may generally be attached to the upper and lower sprints at positions that allow for proper alignment and interface of the rail and groove portions.

[0012] In other embodiments, only one set of rail and groove portions for connecting the upper and lower sprints may be present.

[0013] The rail or groove portion may also generally include a stop to prevent the relative positioning of the upper and lower sprints from proceeding beyond a predetermined point. In some embodiments, the rail portion may include a stop portion such as a portion that does not fit into the groove portion. The stop position may be further adjusted, for example, by placing a spacer on the rail portion that can generally extend the stop portion that does not fit into the groove portion. The spacer may be, for example, of a predetermined or measured size and may be inserted as needed to vary the stop position of the lower sprint relative to the upper sprint. The spacer and / or the rail portion may also include features that assist in locking the spacer in place on the rail portion so that the spacer is held on the rail portion.

[0014] In another aspect of the present invention, the MAD may include features to allow for a small amount of movement between the upper and lower sprints. The connection between the upper and lower sprints may be adapted to accommodate patients who grind their teeth (bruxism) with a lateral left / right movement of the lower teeth (mandible) relative to the upper teeth (maxilla), or to assist, for example, without being bound by a particular theory, in preventing stress on the temporomandibular joint (TMJ) that may cause long-term pain, such that it may be desirable for the MAD wearer to have some degree of jaw mobility and thus not be completely rigid. In some exemplary embodiments, the corresponding shapes of the rail portion and the groove portion of the adjustable mechanism may include some space therebetween, for example, by the shape of the rail portion being smaller than the corresponding shape of the groove portion, such that one portion can move somewhat laterally and / or vertically while interfacing with the other portion.

[0015] In a further aspect of the present invention, the adjustable mechanism can be attached to the MAD using a device that can adjust the positioning and / or orientation of the adjustable mechanism relative to the upper and lower sprints to allow for appropriate horizontal movement. In some exemplary embodiments, the attachment device may include an opening for passing through to hold the groove portion of the MAD and an opening for insertion of the rail portion such that the rail portion can also interface with the groove portion. This may be utilized, for example, when attaching the adjustable mechanism to the upper and / or lower sprints to ensure their proper alignment and positioning when attached, to accommodate non-parallel interfaces of the upper and lower sprints. The attachment device may also include an adjustable section such that the attachment device can be sized laterally to accommodate different widths of the sprints, which may vary due to different jaw shapes and sizes of different people. In some exemplary embodiments, the attachment device may be constructed from two identical components, each of which may include male and female portions to allow interfacing with another identical component in different directions. This may be utilized, for example, to form an adjustable portion.

[0016] The present invention, together with the above and other advantages, can be best understood from the following detailed description of embodiments of the present invention and as shown in the drawings. The following description is given by way of example and not of limitation while showing various embodiments of the present invention and numerous specific details thereof. Many substitutions, changes, additions or rearrangements can be made within the scope of the present invention, and the present invention includes all such substitutions, changes, additions or rearrangements.

[0017] The drawings attached hereto and forming a part thereof are included to depict specific aspects of the present invention. A clearer impression of the present invention and the components and operations of a system incorporating the present invention will be more readily apparent by reference to the exemplary, and thus non-limiting, embodiments illustrated in the drawings, where like reference numerals designate like components. Note that the features illustrated in the drawings are not necessarily drawn to scale.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0019] The detailed description that follows is intended as an explanation of the presently exemplified methods, apparatus, and compositions provided in accordance with aspects of the invention, and is not intended to represent the only forms in which the invention may be practiced or utilized. However, it is understood that different embodiments may achieve the same or equivalent functions and components that are also intended to be encompassed within the spirit and scope of the invention.

[0020] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods, apparatus, and materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the exemplary methods, apparatus, and materials are now described.

[0021] The present invention relates to devices and methods for the treatment of sleep apnea and snoring, and more particularly to devices and methods for mandibular adjustment, and even more particularly to devices and methods related to adjustable and / or customizable mechanisms for positioning and retaining upper and lower splints of a mandibular advancement device (MAD).

[0022] Generally, a MAD device can include an upper splint and a lower splint for holding at least a portion of a person's maxilla and mandible, respectively. FIGS. 1 and 1a show one embodiment of a MAD 100 having an upper splint 102 for accommodating the maxilla and a lower splint 104 for accommodating the mandible. As shown, the upper and lower splints 102, 104 may include channels for holding teeth and may be formed to substantially conform to a person's teeth and / or other anatomical features so as to fit snugly when the MAD is worn. For example, the splints 102, 104 may be formed using a mold taken of a patient's upper and lower teeth to conform to the shape of the patient's teeth, such as by using a dental impression. The amount of material and the size of each splint 102, 104 may depend on the amount of dentition support necessary to effectively adjust the patient's mandibular position, and generally, it may be desirable to utilize sufficient material so as not to place excessive stress on a person's teeth or mouth. The splints 102, 104 may generally be formed to conform and contour to a particular person's jaw, although standardized or general-purpose splints may also be utilized, and the splints 102, 104 may generally have an arcuate shape so as to conform to the normal shape of a human jaw and teeth.

[0023] The splints 102, 104 may generally be formed from any suitable material, such as, for example, acrylic, polycarbonate (PC), polyurethane, polyethylene (PE), polypropylene (PP), polylactic acid (PLA), silicone, nylon, polyvinyl chloride (PVC), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), polyethersulfone (PES), polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), other biocompatible polymers, or any combination thereof.

[0024] The splints 102, 104 can generally be manufactured by, for example, 3D printing, milling, injection molding, and / or other suitable methods.

[0025] The upper and lower sprints 102, 104 may generally be operatively coupled together in an arrangement that promotes the positioning of the lower sprint 104, and thus the positioning of the human mandible, in a more forward position relative to the positioning of the upper sprint 102 and the jaw generally in the horizontal direction A, as illustrated in FIG. 1a.

[0026] In one aspect of the present invention, the MAD 100 may include an adjustable mechanism that can vary the relative positioning of the upper and lower sprints 102, 104. The adjustable mechanism can generally set a relative horizontal difference between the upper and lower sprints 102, 104 such that the lower sprint 104 can be set to a desired forward horizontal position relative to the upper sprint 102, generally for treating apnea and / or snoring through the protruded positioning of the mandible. In some exemplary embodiments, as illustrated in FIGS. 1 and 1a, the adjustment mechanism can be set to a desired forward horizontal position relative to the upper sprint 102. In FIGS. 1 and 1a, the adjustable mechanism can include a rail portion 108 attached to one sprint (e.g., the upper sprint 102 as illustrated) and a corresponding groove portion 106 attached to the other sprint (e.g., the lower sprint 104 as illustrated), with the rail portion 108 and the groove portion 106 fitting or interacting such that the rail portion 108 can slide along (or vice versa) the groove portion 106 to change the relative positions of the upper and lower sprints 102, 104.

[0027] FIGS. 6 and 6a illustrate the effect of the MAD 100 on the positioning of the maxilla 90 and the mandible 92. FIG. 6 shows an example of the jaw position when the MAD 100 is not used, and FIG. 6a shows the effect when the mandible 92 is moved forward of the maxilla 90 in the horizontal direction A.

[0028] Also, the groove portion and the rail portions 106, 108 may be shaped such that the rail portion 108 is held in the groove portion 106, for example, by using corresponding shapes (e.g., male-female connection portions), so that the upper and lower sprints 102, 104 do not separate during use. FIGS. 2, 2a, 2b, 2c illustrate embodiments of corresponding connections between the rail portion 108 and the groove portion 106. FIGS. 2 and 2a illustrate a dovetail-shaped connection in which an enlarged portion 108a of the rail portion 108 fits into a corresponding groove portion 106 so that the enlarged portion 108a is held. FIGS. 2b and 2c illustrate another embodiment using a one-sided dovetail-shaped connection in which the enlarged portion 108b fits into the corresponding groove portion 106. The groove and rail portions 106, 108 can generally be sized appropriately relative to each other for proper functioning, for example, where the rail portion 108 is longer and the groove portion 106 is limited to movement along the length of the rail portion 108, or vice versa.

[0029] In some embodiments, as shown in FIGS. 1 and 1a, at least two sets of rail and groove portions 108, 106 may be included to connect the upper and lower sprints 102, 104. For example, one set may be present on each of the left and right sides of the jaw. The rail and groove portions 108, 106 may generally be attached to the upper and lower sprints 102, 104 at positions that allow proper alignment and interface of the rail and groove portions 108, 106, such as the arcuate left and right sides of the sprints 102, 104.

[0030] In other embodiments, only one set of rail and groove portions 108, 106 that connect the upper and lower sprints 102, 104 may be present.

[0031] The rail portion 108 or the groove portion 106 may also generally include a stop for preventing the relative positioning of the upper and lower springs 102, 104 from proceeding beyond a predetermined point. In some embodiments, as illustrated in the figures, at 1, 1a, 2, 2b, the rail portion 108 may include a stop such as a portion that does not fit into the groove portion 106, as illustrated by the rail stop 108c. The stop position may be further adjusted, for example, by disposing a spacer on the rail portion 108 that generally extends a stop portion that does not fit into the groove portion 106, as illustrated by the spacer 109 in the figures. As illustrated by the spacer 109 at 1, 1a, and 2, the spacer 109 may be, for example, of a predetermined or measured size and may be inserted as needed to vary the stop position of the lower spring 104 relative to the upper spring 102.

[0032] In other embodiments, the groove portion 106 may include a stop, such as having a terminal end of the groove. FIG. 3 is an exploded view of the groove portion 106 having a terminal stop 106a with various different sized spacers 109 that may be inserted prior to inserting the rail portion 108. Generally, the groove portion 106 may be longer than the corresponding rail portion 108 when the spacer 109 is utilized for insertion into the groove portion 106.

[0033] The spacer 109 and / or the rail portion may also include features, where applicable, to assist in locking the spacer 109 in place so that it is retained on the rail portion 108 or within the groove portion 106. For example, features such as friction fits, retaining ridges 108d as shown in FIG. 4, bumps 108e as shown in FIG. 4a, side hooks 108f as shown in FIG. 4b, underhooks 108g as shown in FIG. 4c, and / or any other suitable retaining features may be utilized.

[0034] In another embodiment, the spacer 109 may include features that snap or otherwise retain in at least one of a series of depressions. FIGS. 4d, 4e, 4f, and 4g show the arrangement of the spacer 109 including a snap-in feature 109a retained in a depression 108h on the rail portion 108, with different positions shown depending on the arrangement in different depressions 108h as shown in FIGS. 4e, 4f, and 4g.

[0035] In another aspect of the invention, the MAD 100 may include features to allow for a small amount of movement between the upper and lower sprints 102, 104. The connection between the upper and lower sprints may be such that it accommodates a person wearing the MAD who grinds their teeth (bruxism) with a lateral left / right movement of the lower teeth (mandible) relative to the upper teeth (maxilla), or, for example, without being bound by any particular theory, to provide some relief to prevent stress on the temporomandibular joint (TMJ) that may cause pain over time. It may be desirable for it not to be completely rigid so as to have some degree of jaw mobility. In some exemplary embodiments, the corresponding shapes of the rail and groove portions 108, 106 of the adjustment mechanism may include some space between them, for example, by the shape of the rail portion 108 being smaller than the corresponding shape of the groove portion 106, such that one part can move somewhat laterally and / or vertically while interacting with the other. FIGS. 2a and 2c show an example of a rail portion 108 and a groove portion 106 formed to provide a space 111 such that the rail portion 108 can move somewhat within the groove portion 106 while still being retained.

[0036] In a further aspect of the invention, an adjustable mechanism such as the rail and groove portions 108, 106 can be attached to the MAD 100 using a device that can adjust the position and / or orientation of the adjustable mechanism relative to the upper and lower sprints 102, 104 such that appropriate horizontal movement is possible. This may be desirable as the upper and lower sprints 102, 104 may not have corresponding parallel surfaces when in a fixed position in a person's mouth.

[0037] In some exemplary embodiments, as shown in FIG. 5, the mounting device 200 can include an opening 202 for passing through and holding the groove portion 106 of the MAD100, and an opening 204 for inserting the rail portion 108 so that the rail portion 108 can also interface with the groove portion 106. This can be used, for example, during the attachment of an adjustable mechanism to the upper and / or lower sprints (s) 102, 104 to ensure their proper alignment and positioning when they are attached, such as to accommodate the non-parallel interfaces of the upper and lower sprints 102, 104.

[0038] The mounting device 200 may also include an adjustable section 206 such that, as shown in direction B of FIG. 5a, the mounting device 200 can be sized laterally to accommodate different widths of the sprints 102, 104 that may vary due to the different jaw shapes and sizes of different people. In some exemplary embodiments, the mounting device 200 may be constructed from two identical components, each of which may include male and female portions to enable interfacing with another identical component in different directions. This may be used, for example, to form an adjustable portion. FIG. 5b illustrates a single component 210 having a male connection portion 212 and a female connection portion 214 that can be connected to another component 210 to form a mounting device 200 having lateral adjustability along the interface between the male and female connection portions 212, 214.

[0039] In some embodiments, one of the sprints, such as the lower sprint 104, may be disposed on the holding frame or device, as illustrated in FIG. 5c, and the rails and groove portions 108, 106 inserted into the mounting device 200 may be disposed and attached to the lower sprint 104. The upper sprint 102 may further be disposed at an appropriate position relative to the lower sprint 104 and fixed to the upper portions of the rails and groove portions 108, 106. Thereafter, the mounting device 200 can be removed after the adhesion is completed by sliding the rail portion 108 to release the groove portion 106 and the mounting device 200. Appropriate adhesion methods such as adhesives, heat welding, cross-linking or polymerization, and / or any other appropriate adhesion method can be utilized.

[0040] In some embodiments, the rails and groove portions 108, 106 can also be formed integrally with or co-manufactured with the sprints 102, 104 by 3D printing, milling, injection molding, and / or other appropriate methods.

[0041] While the invention has been described with respect to its specific embodiments, these embodiments are merely illustrative and do not limit the invention. The description of the exemplary embodiments of the invention in this specification, including the description in the abstract and summary, is not intended to be exhaustive or to limit the invention to the exact forms disclosed herein (in particular, including any specific embodiment, feature, or function within the abstract or summary is not intended to limit the scope of the invention to that embodiment, feature, or function). Rather, this specification is intended to provide a context for those skilled in the art to understand the invention without limiting the invention to the specifically described embodiments, features, or functions, including any such embodiment features or functions described in the abstract or summary. The specific embodiments of the invention and examples thereof are described herein for illustrative purposes only, but various equivalent modifications are possible within the spirit and scope of the invention, as will be recognized and understood by those skilled in the relevant art. As shown, these modifications can be made to the invention in light of the foregoing description of the exemplary embodiments of the invention and will be included within the spirit and scope of the invention. Accordingly, while the invention has been described herein with reference to its specific embodiments, a degree of freedom in modification, various changes, and substitutions is intended in the foregoing disclosure, and in some instances, it will be understood that some features of the embodiments of the invention may be employed without the corresponding use of other features without departing from the defined scope and spirit of the invention. Therefore, many modifications may be made to adapt a particular situation or material to the essential scope and spirit of the invention.

[0042] Throughout this specification, references to "one embodiment", "an embodiment", or "a particular embodiment" or the like mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment, but not necessarily in all embodiments. Thus, each appearance of the phrases "in one embodiment", "in an embodiment", or "in a particular embodiment" or the like in various places in this specification is not necessarily referring to the same embodiment. Furthermore, the particular features, structures, or characteristics of any particular embodiment can be combined with one or more other embodiments in any suitable manner. Other variations and modifications of the embodiments described and illustrated herein will be possible in light of the teachings of this specification, and will be considered part of the spirit and scope of the present invention.

[0043] In this specification, numerous specific details are provided in order to provide a thorough understanding of embodiments of the present invention, such as examples of components and / or methods. However, those of ordinary skill in the relevant art will recognize that embodiments may be practiced without one or more of the specific details, or with other devices, systems, assemblies, methods, components, materials, parts, and / or the like. In other instances, well-known structures, components, systems, materials, or operations are not specifically shown or described in detail so as not to obscure aspects of the embodiments of the present invention. The present invention may be illustrated by use of specific embodiments, but this is not intended to limit the present invention to the specific embodiments, and those of ordinary skill in the art will readily understand additional embodiments and recognize that they are part of the present invention.

[0044] As used herein, the terms "comprising", "consisting of", "including", "having", or other variations thereof are intended to cover non-exclusive inclusion. For example, a process, product, article, or apparatus consisting of a list of elements is not necessarily limited to only those elements, but may include other elements not expressly listed, or elements inherent to such a process, process, article, or apparatus.

[0045] Furthermore, as used herein, the term "or" is generally intended to mean "and / or" unless otherwise indicated. For example, the condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or absent), A is false (or absent) and B is true (or present), and both A and B are true (or present). When used in this specification including the following claims, terms preceded by "a" or "an" (and "the" when the antecedent basis is "a" or "an") include both the singular and plural of the term unless otherwise clearly indicated in the claim (i.e., the reference "a" or "an" clearly indicates only singular or only plural). Also, as used herein, the meaning of "in" includes "in" and "on" unless the context clearly indicates otherwise.

Claims

**Claim 1** An apparatus for adjusting the position of the lower jaw, comprising: an upper splint configured to receive at least a portion of the upper teeth of a patient; a lower splint configured to receive at least a portion of the lower teeth of the patient; an upper interface attached to the upper splint; and a lower interface attached to the lower splint, wherein the upper and lower interfaces include at least one set of rail and groove connections formed to hold, interconnect, and project the lower splint forward relative to the upper splint, the rail being attached to one of the upper interface and the lower interface, the groove being attached to the other of the upper interface and the lower interface, the movement of the groove being restricted by a stop on the rail, and the rail and groove connections being adapted such that the rail can slide forward along the groove to change the relative position of the upper splint and the lower splint. **Claim 2** The apparatus according to claim 1, wherein the at least one set of rail and groove connections is formed such that the rail and the groove are interconnected to suppress vertical separation and change the relative position of the upper and lower splints. **Claim 3** The apparatus according to claim 2, further comprising at least one spacer adapted to adjust the forward direction by extending the stop in the groove or extending the stop on the rail. **Claim 4** The apparatus according to claim 2, wherein the at least one set of rail and groove connections includes a lateral space between the rail and the groove and is formed such that the rail and the groove can move laterally and / or vertically relative to each other when interfaced. **Claim 5** The apparatus according to claim 2, wherein the at least one set of rail and groove connections includes left and right sets. **Claim 6** The apparatus according to claim 1, wherein the upper and lower splints are configured to rest in non-parallel orientations relative to each other when the upper and lower interfaces are interconnected. **Claim 7** The apparatus according to claim 5, wherein the left and right sets are connected to the upper and lower splints on the left and right sides of the arcuate portions of the upper and lower splints. **Claim 8** The apparatus according to claim 2, wherein the at least one set of rail and groove connection includes a rail having an ant channel shape and a groove having a corresponding shape.

9. The apparatus according to claim 1, wherein the apparatus is constructed from a material selected from the group consisting of acrylic, polycarbonate (PC), polyurethane, polyethylene (PE), polypropylene (PP), polylactic acid (PLA), silicone, nylon, polyvinyl chloride (PVC), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), polyethersulfone (PES), polyetheretherketone (PEEK), fluorinated ethylene-propylene (FEP), and combinations thereof.

10. The apparatus according to claim 3, wherein the at least one spacer includes features for locking the spacer on the rail.

11. The apparatus according to claim 10, wherein the features for locking the spacer include a snap-in interface.

12. The apparatus according to claim 2, wherein the rail is attached to the upper splint and the groove is attached to the lower splint.

13. The apparatus according to claim 2, wherein the rail is longer than the groove.

14. The apparatus according to claim 3, wherein the at least one spacer is inserted into the groove, the rail is shorter than the groove, and the movement of the rail is restricted by the stop portion in the groove.

15. A method of customizing an apparatus for adjusting a mandibular position, comprising providing an upper splint and a lower splint configured to receive at least a portion of a patient's upper teeth and lower teeth, respectively; Attaching at least one set of rail and groove connections to the upper splint and the lower splint so that the lower splint biases forward in the patient's mouth relative to the upper splint, and adapting the rail to be slidable in the forward direction along the groove so as to change the relative position of the upper splint and the lower splint formed to be held in a connected state with each other, the rail being attached to one of the upper splint and the lower splint, and the groove being attached to the other of the upper splint and the lower splint. To adjust the fit and positioning of the upper and lower splints relative to each other for use by the patient, using a mounting device for holding and adjusting the position of the at least one set of rail and groove connections relative to the upper and lower splints, The groove is prevented from advancing beyond a predetermined point by a stop on the rail, method. **Claim 16**: The method according to claim 15, further comprising adjusting the fit and the positioning of the upper and lower splints relative to each other for use by the patient by adding at least one spacer. **Claim 17** The method according to claim 15, wherein the mounting device adjusts laterally to accommodate different widths of the jaw and arcuate portions of the upper and lower splints. **Claim 18** The method according to claim 15, further comprising securing the at least one rail and groove connection to the upper and lower splints and removing the mounting device after the securing.

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