Devices and methods for sleep apnea and snoring

Abstract

A mandibular advancement device (MAD) for treating snoring and obstructive sleep apnea (OSA) is disclosed. The improved MAD design includes upper and lower splints that can be set in an advanced protrusive position (as required for snoring / OSA therapy) but also allow for some degree of lateral mandibular movement. The amount of protrusive mandibular advancement is adjustable.

Description

[0001] Cross-references to related applications

[0002] This application is a Patent Cooperation Treaty international application and claims the benefit and priority of U.S. Provisional Patent Application Serial No. 62 / 966,797, filed January 28, 2020, entitled “DEVICES AND METHODS FOR SLEEP APNEA AND SNORING,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to apparatus and methods for treating sleep apnea and snoring, particularly to apparatus and methods for mandibular adjustment, and more particularly to apparatus and methods for adjusting and / or customizable mechanisms for positioning and maintaining the upper and lower plates of a mandibular adjustment device. Background Technology

[0004] Snoring is the sound produced by the vibration of soft tissues in the upper airway caused by obstruction of the airway during sleep. Many factors are associated with snoring, including but not limited to: genetics, weight, age, sex, smoking history, tissue abnormalities, alcohol consumption, allergies, and sleeping posture. Often, snorers, and perhaps their sleep partners, experience insomnia due to the snorer's snoring. Lack of sleep can lead to daytime fatigue, a weakened immune system, poor mental and emotional health, irritability, lack of productivity, and other problems.

[0005] Obstructive sleep apnea (“OSA”) is a potentially fatal sleep and breathing disorder defined as cessation of breathing for a certain duration (10 seconds or longer) and at a certain frequency. When breathing is interrupted, the body’s response is to wake up enough to resume breathing. Attacks can occur hundreds of times per night and may not fully wake the individual, otherwise the individual would not be aware of the loud snoring, choking, and gasping typically associated with OSA. Health risks of OSA include a higher risk or incidence of high blood pressure, heart attack, stroke, daytime sleepiness, depression, fibromyalgia, arrhythmias, impaired metabolic efficiency, short-term memory loss, weight gain, acid reflux, high blood pressure, diabetes, severe anxiety, impaired memory and attention, morning headaches, cognitive decline, mood swings / irritable behavior, insomnia, and erectile dysfunction. In addition, many people with OSA do not get enough sleep due to repetitive apnea events and awakenings, which prevents deep sleep and leads to chronic daytime fatigue. An estimated 40 million Americans have some degree of OSA, but only a small fraction of them are currently receiving any type of treatment.

[0006] Snoring and OSA are usually caused by upper airway obstruction when various tissues (including the tongue, uvula, and soft palate) relax. Snoring is caused by partial obstruction of breathing during sleep, while OSA occurs when the tongue and soft palate collapse into the back of the throat and completely block the upper airway, thus stopping breathing and restricting oxygen flow.

[0007] Many techniques exist to reduce or eliminate snoring and OSA. Various types of surgery, including tracheostomy, soft palate and oropharyngeal surgery, and reconstructive surgery, have been used to treat snoring and OSA. However, surgery is expensive, risky, and not always effective.

[0008] Breathing therapies used to treat OSA have also been utilized, typically involving the use of a ventilator-type mask to supply air / oxygen at a pressure higher than atmospheric pressure, commonly known as a continuous positive air pressure (CPAP) system. Variations of this therapy with variable pressure, such as bilevel positive pressure (BiPAP) or multiple positive pressure (MPAP) systems, have also been used. However, these systems exhibit significant patient noncompliance, as patients often find it difficult to adapt to the mask and the pressure it provides. These systems can also be noisy and may affect the patient's sleep partner, to the point that the patient and sleep partner may sleep in separate rooms to ensure each gets a good night's sleep. In other words, patients often dislike and therefore discontinue using these types of breathing therapies.

[0009] Another type of snoring / OSA solution involves devices worn by patients to reposition their jaws to suppress airway closure. These devices are often called mandibular advancement devices (MADs) or mandibular advancement splints. MADs treat snoring and OSA by slightly forward-leaning the mandible (lower jaw) in a forward-leaning (roughly horizontal) direction relative to the maxilla (upper jaw). This tightens the soft tissues of the upper airway, preventing obstruction during sleep. This tightening also suppresses the vibration of these tissues as air passes through them, thus reducing snoring. MADs are generally less bulky than respiratory therapy systems (CPAP, BiPAP, etc.), thus improving patient compliance. MADs can be prescribed by different types of doctors, but given that they are worn on the teeth, MADs are usually manufactured and fitted under the guidance of a dentist, orthodontist, etc. Summary of the Invention

[0010] This invention relates to apparatus and methods for treating sleep apnea and snoring, particularly to mandibular adjustment devices and methods, and more particularly to apparatus and methods for positioning and maintaining adjustable and / or customizable mechanisms for the upper and lower splints of a mandibular adjustment device (MAD).

[0011] Generally, a MAD device may include an upper splint and a lower splint, each splint used to hold at least a portion of a person's upper jaw (maxilla) and lower jaw (mandible). The splints can typically be shaped to fit and contour to a particular person's jaw, for example, by using dental impressions; however, standardized or universal splints may also be used. The upper and lower splints can typically be operatively joined together in an arrangement that facilitates the positioning of the lower splint and thus promotes a more forward position of the person's mandible relative to the upper splint and jaw in a generally horizontal direction.

[0012] In one aspect of the invention, the MAD may include an adjustable mechanism that alters the relative positioning of the upper and lower clamps. The adjustable mechanism typically sets a relative horizontal difference between the upper and lower clamps such that the lower clamp can be positioned relative to the upper clamp at a desired forward horizontal position to treat sleep apnea and / or snoring through jaw protrusion positioning. In some exemplary embodiments, the adjustable mechanism may include a guide rail portion attached to one clamp and a corresponding recessed portion attached to the other clamp, the guide rail portion and the recessed portion engaging or mating such that the guide rail portion can slide along the recessed portion (and vice versa) to alter the relative positioning of the upper and lower clamps. The recessed portion and the guide rail portion may also be shaped such that the guide rail portion is retained within the recessed portion to prevent the upper and lower clamps from separating during use, for example, by using corresponding shapes (e.g., a convex-concave connection).

[0013] In some embodiments, at least two sets of guide rails and recessed portions may be included to connect the upper and lower clamping plates. For example, there may be one set on the left and one on the right side of the jaw. The guide rails and recessed portions are typically attached to the upper and lower clamping plates at locations that allow the guide rails to be properly aligned and mated with the recessed portions.

[0014] In other embodiments, there may only be a set of guide rails and grooves connecting the upper and lower clamping plates.

[0015] The guide rail or recessed portion typically also includes a stop to prevent the relative positioning of the upper and lower clamping plates from exceeding a given point. In some embodiments, the guide rail portion may include a stop, such as a portion not fitted into the recessed portion. The stop position can be further adjusted, for example, by placing spacers on the guide rail portion, which typically extend beyond the stop portion not fitted into the recessed portion. For example, the spacers may be of a predetermined or measured size and can be inserted as needed to change the stopped position of the lower clamping plate relative to the upper clamping plate. The spacers and / or the guide rail portion may also include features that help lock the spacers in place, such that they remain on the guide rail portion.

[0016] In another aspect of the invention, the MAD may include features enabling a small amount of movement between the upper and lower splints. It may be desirable that the connection between the upper and lower splints is not entirely rigid, allowing the wearer of the MAD a degree of jaw flexibility, for example, to accommodate patients with bruxism (teeth grinding), which involves lateral left / right movement of the lower teeth (mandible) relative to the upper teeth (maxillary), or to help, for example, but not limited to, prevent compression of the temporomandibular joint (TMJ), which can lead to chronic pain. In some exemplary embodiments, the corresponding shapes of the guide portion and the recessed portion of the adjustable mechanism may include some space between them, for example, by making the shape of the guide portion smaller than the corresponding shape of the recessed portion, so that one portion can move laterally and / or vertically to a certain extent when engaged.

[0017] In another aspect of the invention, the adjustable mechanism can be mounted to the MAD using a means that allows adjustment of the positioning and / or orientation of the adjustable mechanism relative to the upper and lower clamps, thereby enabling proper horizontal movement. In some exemplary embodiments, the mounting means may include a hole through which a recessed portion of the MAD passes to retain the recessed portion and a hole for insertion of a guide portion, such that the guide portion can also mate with the recessed portion. This can be used during the attachment of the adjustable mechanism to the upper and / or lower clamps to ensure proper alignment and positioning during attachment, for example, to accommodate non-parallel mating of the upper and lower clamps. The mounting means may also include an adjustable section such that the dimensions of the mounting means can be laterally adjusted to accommodate clamps of different widths, the width of which may vary due to different jaw shapes and sizes of different individuals. In some exemplary embodiments, the mounting means may consist of two identical components, each of which may include a convex portion and a concave portion to allow mating with another identical component in different orientations. For example, this can be used to form the adjustable section.

[0018] The invention and its above and other advantages will be better understood from the following detailed description of embodiments of the invention and the accompanying drawings. While the following description indicates various embodiments of the invention and many specific details thereof, it is given by way of illustration rather than limitation. Many substitutions, modifications, additions, or rearrangements can be made within the scope of the invention, and the invention encompasses all such substitutions, modifications, additions, or rearrangements. Attached Figure Description

[0019] The accompanying drawings, which form part of this specification, are used to describe certain aspects of the invention. A clearer impression of the invention, and the components and operation of the systems provided by the invention, will become more apparent by referring to the exemplary and therefore non-limiting embodiments shown in the drawings, in which the same reference numerals denote the same components. Note that the features shown in the drawings are not necessarily drawn to scale.

[0020] Figure 1 and 1a An embodiment of a MAD with an adjustable mechanism is shown;

[0021] Figure 2 , Figure 2a , Figure 2b and Figure 2c An embodiment of the adjustable mechanism's guide rail and groove portion is shown;

[0022] Figure 3 An exploded view of the adjustable mechanism is shown, including the recessed portion with end stops, a set of spacers, and the guide rail portion.

[0023] Figure 4 , Figure 4a , Figure 4b , Figure 4c , Figure 4d , Figure 4e , Figure 4f and Figure 4g An embodiment of the spacer holding feature is shown;

[0024] Figure 5 , Figure 5a , Figure 5b and Figure 5c The mounting device and its use in attaching the adjustable mechanism to the MAD are shown; and

[0025] Figure 6 and Figure 6a The effect of MAD on human jaw position is shown. Detailed Implementation

[0026] The detailed description set forth below is intended to describe the currently exemplary methods, apparatuses, and compositions provided according to various aspects of the invention, and is not intended to represent only the forms in which the invention may be practiced or utilized. However, it should be understood that the same or equivalent functions and components may be implemented through different embodiments, which are also intended to be included within the spirit and scope of the invention.

[0027] Unless otherwise defined, 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 pertains. Although any methods, apparatus, and materials similar to or equivalent to those described herein may be used in the practice or testing of this invention, illustrative methods, apparatus, and materials are described here.

[0028] This invention relates to devices and methods for treating sleep apnea and snoring, particularly to devices and methods for mandibular adjustment, and more particularly to devices and methods for adjusting and / or customizable mechanisms for positioning and maintaining the upper and lower splints of a mandibular adjustment device (MAD).

[0029] Generally, a MAD device may include an upper splint and a lower splint, each splint being used to hold at least a portion of a person's upper jaw (maxilla) and lower jaw (mandible). Figure 1 and Figure 1a An embodiment of the MAD 100 is shown, having an upper splint 102 for adaptation to the maxilla and a lower splint 104 for adaptation to the mandible. As shown, the upper splint 102 and lower splint 104 may include channels for holding teeth and may be shaped to substantially conform to human teeth and / or other anatomical features, such that they fit snugly when the MAD is worn. For example, splints 102, 104 may be formed using molds taken from the patient's upper and lower teeth to conform to the shape of the patient's teeth, for example, using dental impressions. The amount of material and size of each splint 102 and 104 may depend on the amount of dental support required for effective adjustment of the patient's mandibular position, and it may generally be desirable to utilize sufficient material to prevent excessive stress on the human teeth or oral cavity. Splints 102, 104 may generally be shaped to fit and contour to the jaw of a particular person; however, standardized or universal splints may also be used, and splints 102, 104 may generally have an arched shape to conform to the normal shape of a human jaw and teeth.

[0030] Plyboards 102 and 104 can typically be made of any suitable material, such as 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), polyether ether ketone (PEEK), fluorinated ethylene propylene (FEP), other biocompatible polymers, or any combination thereof.

[0031] Clamping plates 102 and 104 can typically be manufactured by appropriate methods, such as 3D printing, milling, injection molding, and / or other appropriate methods.

[0032] The upper splint 102 and the lower splint 104 are typically operably connected together, and their arrangement facilitates the positioning of the lower splint 104, thereby placing the person's lower jaw in a more forward position relative to the upper splint 102 and the jaw in a generally horizontal direction A, such as... Figure 1a As shown.

[0033] In one aspect of the invention, the MAD 100 may include an adjustable mechanism that can change the relative positioning of the upper clamp 102 and the lower clamp 104. The adjustable mechanism can typically set a relative horizontal difference between the upper clamp 102 and the lower clamp 104, such that the lower clamp 104 can be positioned relative to the upper clamp 102 at a desired forward horizontal position to treat sleep apnea and / or snoring through jaw protrusion positioning. In some exemplary embodiments, such as Figure 1 and 1a As shown, the adjustable mechanism may include a guide rail portion 108 attached to one clamp (e.g., the upper clamp 102 shown) and a corresponding groove portion 106 attached to another clamp (e.g., the lower clamp 104 shown). The guide rail portion 108 engages or mates with the groove portion 106, such that the guide rail portion 108 can slide along the groove portion 106 (or vice versa) to change the relative positioning of the upper clamp 102 and the lower clamp 104.

[0034] Figure 6 and Figure 6a The effect of MAD 100 on the positioning of the maxilla 90 and mandible 92 is shown. Figure 6 The image shows an example of jaw position without MAD100, while Figure 6a The effect of moving the lower jaw 92 in front of the upper jaw 90 in the horizontal direction A is shown.

[0035] The shapes of the groove portion 106 and the guide rail portion 108 can also keep the guide rail portion 108 in the groove portion 106 to prevent the upper clamping plate 102 and the lower clamping plate 104 from separating during use, for example, by using corresponding shapes (e.g., convex-concave connection). Figure 2 , Figure 2a , Figure 2b and Figure 2c An embodiment of the corresponding connection between the guide rail portion 108 and the groove portion 106 is shown. Figure 2 and Figure 2a A dovetail connection is shown, wherein the enlarged section 108a of the guide rail portion 108 is fitted into the corresponding recessed portion 106, such that the enlarged section 108a is held in place. Figure 2b and Figure 2c Another embodiment using a single-sided dovetail joint is shown, wherein the enlarged segment 108b is fitted into a corresponding recessed portion 106. The recessed portion 106 and the guide portion 108 can generally be appropriately sized relative to each other to achieve the correct function; for example, if the guide portion 108 is longer, the recessed portion 106 is restricted to move along the length of the guide portion 108, and vice versa.

[0036] In some embodiments, at least two sets of groove portions 106 and guide rail portions 108 may be included to connect the upper clamping plate 102 and the lower clamping plate 104, such as Figure 1 and 1a As shown. For example, there is one set on the left and right sides of the jaw. The groove portion 106 and the guide portion 108 can typically be attached to the upper clamping plate 102 and the lower clamping plate 104 at positions that allow the groove portion 106 and the guide portion 108 to be properly aligned and mated, for example on the left and right sides of the arcuate shape of the clamping plates 102, 104.

[0037] In other embodiments, there may only be a set of guide rail portions 108 and groove portions 106 connecting the upper clamping plate 102 and the lower clamping plate 104.

[0038] The guide rail portion 108 or the recessed portion 106 typically also includes a stop to prevent the relative positioning of the upper clamping plate 102 and the lower clamping plate 104 from exceeding a given point. In some embodiments, such as Figure 1 , Figure 1a , Figure 2 , Figure 2b As shown, the guide rail portion 108 may include a stop, such as a portion not fitted into the recessed portion 106, as shown in guide rail stop 108c. The stop position can be further adjusted, for example, by placing a spacer on the guide rail portion 108, which typically extends the stop portion not fitted into the recessed portion 106, as shown in... Figure 1 , Figure 1a and Figure 2 The spacer 109 is shown in the diagram. For example, the spacer 109 may be of a predetermined or measured size and may be inserted as needed to change the stopped position of the lower clamp 104 relative to the upper clamp 102.

[0039] In other embodiments, the groove portion 106 may include a stop, such as a stop with a grooved end. Figure 3 An exploded view of a recessed portion 106 having an end stop 106a having spacers 109 of various sizes that can be inserted before the insertion guide portion 108 is inserted. Typically, when the spacers 109 are used for insertion into the recessed portion 106, the recessed portion 106 can be longer than the corresponding guide portion 108.

[0040] The spacer 109 and / or guide rail portion may also include features that help lock the spacer 109 in place, so as to retain it in the guide rail portion 108 or the recessed portion 106 (if applicable). For example, features such as friction fits may be used. Figure 4 The diagram shows the maintenance of the spine for 108 days. Figure 4a The protrusion 108e shown Figure 4b The side hook 108f shown Figure 4c The lower hook 108g and / or any other suitable retaining feature shown.

[0041] In another embodiment, the spacer 109 may include a feature that snaps into or is otherwise held by at least one of a series of recesses. Figure 4d , Figure 4e , Figure 4f and Figure 4g The placement of the spacer 109 is shown. The spacer includes a snap-fit ​​feature 109a held in a recess 108h on the guide rail portion 108, which is placed as shown in the figure. Figure 4e , Figure 4f and Figure 4g The different locations are shown in the different depressions 108h.

[0042] In another aspect of the invention, the MAD 100 may include features enabling a small amount of movement between the upper splint 102 and the lower splint 104. It may be desirable that the connection between the upper and lower splints is not entirely rigid, allowing the wearer of the MAD a degree of jaw flexibility, for example, to accommodate patients with bruxism (teeth grinding), which involves lateral left / right movement of the lower teeth (mandible) relative to the upper teeth (maxillary), or to help, for example, but not limited to any particular theory, prevent compression of the temporomandibular joint (TMJ), which can lead to chronic pain. In some exemplary embodiments, the corresponding shapes of the guide portion 108 and the recess portion 106 of the adjustable mechanism may include some space between them, for example, by the shape of the guide portion 108 being smaller than the corresponding shape of the recess portion 106, such that one portion can move laterally and / or vertically to a certain extent when engaged. Figure 2a and Figure 2c An example of a guide rail portion 108 and a recessed portion 106 is shown, which are shaped to provide space 111 such that the guide rail portion 108 can move to a certain extent within the recessed portion 106 while still being held in place.

[0043] In another aspect of the invention, the adjustable mechanism, such as the guide rail portion 108 and the recessed portion 106, can be mounted on the MAD 100 using a device that allows adjustment of the positioning and / or orientation of the adjustable mechanism relative to the upper clamp 102 and the lower clamp 104, thereby enabling proper horizontal movement. This may be desirable because the upper clamp 102 and the lower clamp 104 may not have corresponding parallel surfaces when in place in a person's mouth.

[0044] In some exemplary embodiments, such as Figure 5As shown, the mounting device 200 may include a hole 202 through which a recessed portion 106 of the MAD 100 passes to retain the recessed portion 106, and a hole 204 for insertion of a guide portion 108, such that the guide portion 108 may also mate with the recessed portion 106. This can be used in the process of attaching the adjustable mechanism to the upper clamp 102 and / or the lower clamp 104 to ensure that they are properly aligned and positioned during attachment, for example, to accommodate non-parallel mating of the upper clamp 102 and the lower clamp 104.

[0045] The mounting device 200 may also include an adjustable section 206 so that the mounting device 200 can be laterally adjusted in size, such as... Figure 5a As shown in direction B, clamps 102 and 104 of varying widths are accommodated, the widths of which can vary depending on the different jaw shapes and sizes of different individuals. In some exemplary embodiments, the mounting device 200 may consist of two identical components, each of which may include a convex portion and a concave portion to allow mating with another identical component in different orientations. For example, this can be used to form an adjustable section. Figure 5b A single component 210 with a convex connector 212 and a concave connector 214 is shown, which can be connected to another component 210 to form a mounting device 200 having lateral adjustability along the interface between the convex connector 212 and the concave connector 214.

[0046] In some embodiments, one of the clamps, such as clamp 104, may be placed in a retaining frame or device, such as Figure 5c As shown, the guide rail portion 108 and recessed portion 106 of the insertion mounting device 200 can be placed and adhered to the lower clamping plate 104. The upper clamping plate 102 can be further positioned relative to the lower clamping plate 104 and adhered to the upper portion of the recessed portion 106 and the guide rail portion 108. Once adhesion is complete, the mounting device 200 can then be removed by sliding out the guide rail portion 108, thereby releasing the recessed portion 106 and the mounting device 200. Suitable adhesion methods can be used, such as adhesives, thermal welding, crosslinking or polymerization, and / or any other suitable adhesion methods.

[0047] In some embodiments, the guide rail portion 108 and the groove portion 106 may also be integrally formed or co-manufactured with the clamping plates 102, 104, for example by 3D printing, milling, injection molding and / or other suitable methods.

[0048] Although the invention has been described with reference to specific embodiments thereof, these embodiments are merely illustrative and not intended to limit the invention. The description of the illustrated embodiments of the invention herein, including the description in the abstract and summary of the invention, is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein (in particular, the inclusion of any specific embodiment, feature, or function in the abstract or summary of the invention is not intended to limit the scope of the invention to such embodiments, features, or functions). Rather, the specification is intended to describe illustrative embodiments, features, and functions to provide an understanding of the invention to those skilled in the art, without limiting the invention to any specifically described embodiments, features, or functions, including any such embodiment features or functions described in the abstract or summary of the invention. While the specific embodiments and examples of the invention described herein are for illustrative purposes only, various equivalent modifications are possible within the spirit and scope of the invention, as will be recognized and understood by those skilled in the art. As noted, these modifications can be made to the invention based on the foregoing description of the illustrated embodiments according to the invention, and such modifications will be included within the spirit and scope of the invention. Therefore, although the invention has been described herein with reference to specific embodiments thereof, modifications, various alterations and substitutions are contemplated in the foregoing disclosure, and it will be understood that in some cases, some features of embodiments of the invention will be employed without correspondingly using other features, without departing from the scope and spirit of the invention as set forth. Thus, many modifications can be made to adapt particular situations or materials to the essential scope and spirit of the invention.

[0049] Throughout this specification, the terms "one embodiment," "an embodiment," or "a particular embodiment," or similar terms, refer to a specific feature, structure, or characteristic associated with that embodiment that is included in at least one embodiment, but not necessarily in all embodiments. Therefore, the respective appearances of the phrases "in one embodiment," "in one embodiment," or "in a particular embodiment," or similar terms throughout this specification do not necessarily refer to the same embodiment. Furthermore, any particular feature, structure, or characteristic of any particular embodiment can be combined with one or more other embodiments in any suitable manner. It should be understood that other variations and modifications of the embodiments described and illustrated herein are possible in accordance with the teachings herein and are considered part of the spirit and scope of the invention.

[0050] Throughout this description, numerous specific details, such as examples of components and / or methods, are provided to provide a comprehensive understanding of embodiments of the invention. However, those skilled in the art will recognize that embodiments can be practiced without one or more of these specific details, or using other devices, systems, components, methods, parts, materials, components, etc. In other instances, well-known structures, components, systems, materials, or operations have not been specifically shown or described in detail to avoid obscuring aspects of the embodiments of the invention. While the invention may be illustrated by using specific embodiments, this is not and does not limit the invention to any particular embodiment, and those skilled in the art will recognize that additional embodiments are readily understood and are part of the invention.

[0051] As used herein, the terms “comprising,” “including,” “containing,” “having,” “having,” “owning,” or any other variation thereof are intended to cover non-exclusive inclusion. For example, a process, product, article, or apparatus that includes a list of elements is not necessarily limited to those elements, but may include other elements not expressly listed or inherent to such process, product, or apparatus.

[0052] Furthermore, the term “or” as used herein generally means “and / or” unless otherwise stated. For example, condition A or B satisfies any of the following conditions: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); or both A and B are true (or exist). As used herein, including in the appended claims, terms preceded by “an” or “a” (or “the” when the preceding basis is “an” or “a”) include both the singular and plural forms of that term, unless otherwise clearly indicated in the claims (i.e., a reference to “an” or “a” clearly indicates either the singular or the plural only). Furthermore, as used herein, “in” means both “in” and “on”, unless the context clearly specifies otherwise.

Claims

1. A device for adjusting the position of the mandible, comprising: An upper splint, the upper splint being configured to receive at least some of the patient's upper teeth; A lower splint, the lower splint being configured to receive at least some of the patient's lower teeth; Attached to the upper interface of the upper clamping plate; as well as The lower interface is attached to the lower clamping plate; The upper and lower interfaces include at least one set of guide rails and groove connectors shaped to hold the upper and lower interfaces, which are interconnected and project forward relative to the lower clamping plate. The guide rails are attached to the upper interface, and the grooves are attached to the lower interface, or vice versa, and the movement of the grooves is constrained by stops on the guide rails. The at least one set of guide rail and groove connectors includes a lateral space between the guide rail and the groove and is configured to allow the guide rail and the groove to move laterally and / or vertically relative to each other during mating. The at least one set of guide rails and groove connectors includes a dovetail guide rail and a groove of a corresponding shape.

2. The apparatus according to claim 1, wherein, The at least one set of guide rails and groove connectors are adapted to allow the guide rails to slide along the grooves to change the position of the upper clamping plate and the lower clamping plate relative to each other.

3. The apparatus of 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 guide rail.

4. The apparatus according to claim 2, wherein, The at least one set of guide rails and groove connectors includes a left set and a right set.

5. The apparatus according to claim 1, wherein, The upper and lower clamps are configured to be non-parallel to each other when the upper and lower interfaces are interconnected.

6. The apparatus according to claim 4, wherein, The left and right groups are connected to the upper and lower clamping plates on the left and right sides of the arcuate portions of the upper and lower clamping plates, respectively.

7. The apparatus according to claim 1, wherein, The device is composed of materials selected from acrylic acid, polycarbonate (PC), polyurethane, polyethylene (PE), polypropylene (PP), polylactic acid (PLA), silicone resin, nylon, polyvinyl chloride (PVC), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), polyethersulfone (PES), polyether ether ketone (PEEK), fluorinated ethylene propylene rubber (FEP), and combinations thereof.

8. The apparatus according to claim 3, wherein, The at least one spacer includes a feature for locking the spacer onto the guide rail.

9. The apparatus according to claim 8, wherein, The feature for locking the spacer includes a snap-fit ​​interface.

10. The apparatus according to claim 2, wherein, The guide rail is attached to the upper clamping plate, and the groove is attached to the lower clamping plate.

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

12. The apparatus according to claim 3, wherein, At least one spacer is inserted into the groove, the guide rail is shorter than the groove, and the movement of the guide rail is constrained by a stop in the groove.

13. A method for customizing a device for adjusting the position of the mandible, comprising: An upper splint and a lower splint are provided, the upper splint and the lower splint being configured to receive at least some of the patient's upper teeth and lower teeth, respectively; At least one set of guide rails and groove connectors are attached to the upper and lower splints, such that the lower splint is forward-biased relative to the upper splint in the patient's oral cavity, and adapted to allow the guide rails to slide along the grooves to change the position of the upper and lower splints relative to each other. The guide rails and the grooves are shaped to hold each other in connection, and the guide rails are attached to the upper splint and the grooves are attached to the lower splint, or vice versa. An installation device is used to hold and adjust the position of the at least one set of guide rails and groove connectors relative to the upper and lower splints to adjust the assembly and positioning of the upper and lower splints relative to each other for use by the patient. in, The stop on the guide rail prevents the groove from advancing beyond a given point during movement. The at least one set of guide rail and groove connectors includes a lateral space between the guide rail and the groove and is configured to allow the guide rail and the groove to move laterally and / or vertically relative to each other during mating. The at least one set of guide rails and groove connectors includes a dovetail guide rail and a groove of a corresponding shape.

14. The method of claim 13, further comprising adjusting the assembly and positioning of the upper and lower splints relative to each other by adding at least one spacer for use by the patient.

15. The method according to claim 13, wherein, The mounting device is laterally adjustable to accommodate different jaw widths and the arched portions of the upper and lower clamps.

16. The method of claim 13, further comprising adhering the at least one set of guide rails and groove connectors to the upper and lower clamping plates, and removing the mounting device after the adhering.

Images