Oropharynx appliance to maintain airway patency

Abstract

To provide an oropharynx appliance.SOLUTION: An oropharynx appliance according to one aspect of the present disclosure includes passive tongue retention structure (12) having an end portion (16) adapted to prevent a pharyngeal portion of a tongue of a subject from collapsing; and at least one anchoring structure (14, 148) that is connected to the passive tongue retention structure to removably secure the passive tongue retention structure to at least one tooth / mandible of the subject. The passive tongue retention structure is sized and dimensioned such that the end portion prevents the posterior pharyngeal portion of the tongue from obstructing an oropharynx during sleep, without triggering a gag reflex, while still permitting the tongue to move during swallowing.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 464,702, entitled "Tongue Retention Dummy for Obstructive Sleep Apnea," filed February 28, 2017, and U.S. Provisional Application No. 62 / 516,863, entitled "Oropharyngeal Protection Device," filed June 8, 2017. This application further claims priority to U.S. Provisional Application No. 62 / 567,358, entitled "System and Method for Obstructive Sleep Apnea Detection and Monitoring," filed October 3, 2017. The disclosures of these provisional applications are incorporated herein by reference for all purposes.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to obstructive sleep apnea, and more particularly, to oropharyngeal devices that maintain an open airway during sleep to prevent or treat obstructive sleep apnea. [Background technology]

[0003] Sleep apnea is a sleep disorder in which patients have difficulty breathing during sleep. Such difficulty in breathing during sleep leads to nocturnal hypoxemia and sleep fragmentation, which may lead to medical comorbidities (e.g., daytime sleepiness), as well as cardiac and neurological complications. The most common type of sleep apnea is obstructive sleep apnea, which affects 27 million patients in the United States alone. Obstructive sleep apnea is characterized by repeated collapse of soft tissues during sleep that obstruct the upper airway. Airway obstruction results in cessation of breathing or hypopnea or bradypnea, which may occur multiple times during the night. Individuals suffering from sleep apnea are rarely aware of their breathing difficulties even when they wake up, leading to associated poor diagnosis and treatment. Indeed, there is no pharmacological therapy to treat sleep apnea. Although several mechanical therapies exist, such as continuous positive airway pressure (CPAP) therapy and mandibular advancement device (MAD) therapy, these therapies are often used inappropriately, poorly tolerated, and / or ineffective. Summary of the Invention [Problem to be solved by the invention]

[0004] FIELD OF THE DISCLOSURE The present disclosure relates to obstructive sleep apnea, and more particularly, to oropharyngeal devices that maintain an open airway during sleep to prevent or treat obstructive sleep apnea. [Means for solving the problem]

[0005] In one aspect, the present disclosure may include an oropharyngeal appliance configured to maintain an open airway during sleep. The oropharyngeal appliance includes a passive tongue-retaining structure having a terminal end adapted to prevent pharyngeal collapse of the subject's tongue. The oropharyngeal appliance may further include at least one anchor structure connected to the passive tongue-retaining structure and adapted to releasably secure the passive tongue-retaining structure within the subject's oral cavity while allowing movement. The passive tongue-retaining structure is dimensioned such that the terminal end prevents obstruction of the oropharyngeal passage during sleep without eliciting a gag reflex while allowing the tongue to move during swallowing.

[0006] In another aspect, the present disclosure can include an oropharyngeal system capable of maintaining an open airway during sleep. The system can include an oropharyngeal appliance dimensioned to prevent a terminal portion of the subject's tongue from obstructing the oropharynx during sleep without triggering a gag reflex, while allowing the tongue to move during swallowing. The system can further include an anchoring system adapted to fit snugly with the oropharyngeal appliance to secure a portion of the oropharyngeal appliance in a predetermined anatomical location.

[0007] In another aspect, the present disclosure can include a method of fitting an oropharyngeal appliance in a subject's mouth, the appliance being adapted to maintain an open airway during sleep. Images of the subject's oral cavity can be taken. Based on these images, the oropharyngeal appliance can be manufactured. After manufacture, the oropharyngeal appliance can be fitted to the oral cavity of the subject. [Brief description of the drawings]

[0008] These and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure pertains upon reading the following description in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a schematic diagram showing a system for restricting tongue collapse into the oropharynx. [Diagram 2] FIG. 1 is a schematic diagram illustrating an example of an oropharyngeal device configured to keep an airway open during sleep to prevent or treat obstructive sleep apnea, according to one aspect of the present disclosure. [Diagram 3] 2 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 1. [Figure 4] 2 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 1. [Diagram 5] 2 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 1. [Figure 6] 2 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 1. [Figure 7] 2 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 1. [Figure 8] FIG. 1 is a schematic diagram illustrating an example oropharyngeal device for maintaining a patent airway during sleep to prevent or treat obstructive sleep apnea, according to another aspect of the present disclosure. [Figure 9] 9 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 8. [Figure 10] 9 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 8. [Figure 11] 9 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 8. [Figure 12] 9 is a schematic diagram showing a different example of the oropharyngeal device of FIG. 8. [Figure 13] 9 is a photograph showing the oropharyngeal device attached to the mouthguard in FIG. 8. [Figure 14] FIG. 11 is a process flow diagram illustrating a method of placing an oropharyngeal appliance in a subject's oral cavity, according to another aspect of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] I. Definition Unless otherwise specified, technical terms used herein have the same meaning as commonly understood by those skilled in the art.

[0010] In the context of this disclosure, the singular forms "one", "one" and "the" may include the plural forms unless specifically stated otherwise.

[0011] As used herein, the terms "comprise" and / or "comprising" may specify the presence of said features, steps, operations, elements and / or components, but do not exclude the presence of one or more other features, steps, operations, elements, components and / or groups.

[0012] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0013] It should be understood that when an element is referred to as being "on another element," "mounted on another element," "connected to another element," "coupled to another element," "in contact with another element," or the like, it may be directly located on, directly mounted on, directly connected to, directly coupled to, or in direct contact with the other element, or there may be intervening elements present. Conversely, when an element is referred to as being, for example, "directly coupled to, or in direct contact with, another element," there are no intervening elements present. Those skilled in the art will also understand that references to structures or features located "adjacent" to another feature may have portions that cover or underlie the adjacent feature.

[0014] For convenience of description, spatially relative terms such as "below," "under," "lower," "above," "above," etc. may be used herein to describe the relationship of one element or feature to other elements or features shown in the figures. Spatially relative terms may also include different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, elements described as "below" or "below" other elements would be oriented "above" the other elements or features.

[0015] In addition, although terms such as "first" and "second" may be used herein to describe various elements, these elements are not limited to these terms. These terms are used only to distinguish one element from another. Thus, a "first" element described below may be called a "second" element without departing from the teachings of the present disclosure. In addition, unless otherwise specified, the sequence of operations (or acts / steps) is not limited to the order shown in the claims or drawings.

[0016] As used herein, "obstructive sleep apnea" means a sleep disorder caused by complete or partial obstruction of a subject's airway, resulting in repeated episodes of hypopnea or apnea during sleep despite the subject's efforts to breathe. The obstruction may be caused by soft tissue collapsing into the oropharynx of the subject's upper airway.

[0017] As used herein, "mandible" can refer to a subject's lower jaw, which is the only movable skeletal structure within the skull.

[0018] As used herein, "mouth" can refer to the surrounding structures or structures within the oral cavity. The mouth can include the teeth and the tongue.

[0019] As used herein, "oral cavity" can refer to the cavity of the mouth and is defined by the maxilla, mandible, and cheeks.

[0020] The term "tongue" as used herein may refer to the fleshy muscular organ in the oral cavity of a subject. The tongue may be composed of an anterior oral portion and a posterior pharynx. The posterior pharynx may be the posterior third of the tongue, which is part of the oropharynx.

[0021] As used herein, the term "oropharynx" can refer to the part of the throat behind the mouth. The oropharynx begins where the oral cavity ends and includes the posterior pharynx of the tongue.

[0022] As used herein, "arched" means generally curved in shape. Arched shapes include, for example, arcs, bows, etc. However, in some instances, an arched shape may include one or more bent portions, linear portions, or other curved configurations, so long as a general curvature is present.

[0023] As used herein, a "spring" can refer to a resilient device that can be pushed or pulled, but returns to its original shape when released. In some examples, the spring may be at least partially helically shaped. Exemplary uses of springs include providing constant tension or absorbing movement.

[0024] As used herein, an "instrument" may refer to an apparatus configured to perform a particular task. The term "device" may be used interchangeably with the term "instrument."

[0025] As used herein, "prevent" can mean to prevent something from happening or occurring. For example, when worn by a subject who snores, the oropharyngeal appliance can prevent the subject from developing obstructive sleep apnea.

[0026] As used herein, the term "treatment" can refer to treating or curing a medical disorder. As an example, when placed on a subject with obstructive sleep apnea, an oropharyngeal device can treat obstructive sleep apnea by preventing the tongue and other soft tissue from entering the oropharynx.

[0027] The term "wire" as used herein can refer to a metal, polymer, composite, or other material structure. In some cases, the cross-sectional area of ​​the material structure may be constant. In other instances, the cross-sectional area of ​​the material structure may vary from at least one portion of the wire to another portion of the wire. The cross-section of the wire may be circular, bent, rectangular, linear, flat, curved, star-shaped, or any other shape.

[0028] As used herein, the terms "subject" and "patient" may be used interchangeably and refer to any warm-blooded organism, including, but not limited to, humans, pigs, rats, mice, dogs, cats, goats, sheep, horses, monkeys, apes, rabbits, cows, etc.

[0029] II. Overview The present disclosure generally relates to the prevention or treatment of obstructive sleep apnea. Prevention or treatment can be achieved with the aid of an oropharyngeal appliance, a mechanical device that prevents airway obstruction during sleep due to soft tissue (e.g., tongue) entering the oropharynx. In patients suffering from sleep apnea, the tongue muscles relax during sleep, allowing the tongue to retract into the oropharynx due to negative pressure generated during inspiration. The oropharyngeal appliance prevents the tongue from moving backwards into the oropharynx during sleep, thereby keeping the airway open.

[0030] The oropharyngeal appliance may include a passive tongue-retaining structure capable of preventing the tongue from moving backwards, and at least one anchor structure adapted to removably secure and permit movement of the passive tongue-retaining structure within the subject's mouth. The passive tongue-retaining structure may be configured to allow air to pass during sleep without inducing a gag reflex, and to permit the tongue to move during swallowing. For example, the passive tongue-retaining structure may be configured to be retained in a plane parallel to the mandible. However, the passive tongue-retaining structure may be positioned on the surface of the tongue.

[0031] III. System One aspect of the present disclosure may include an oropharyngeal appliance that keeps an airway open during sleep to prevent or treat obstructive sleep apnea. The oropharyngeal appliance may be part of a system that includes a dental device (e.g., mouthpiece 148) to secure the passive tongue-retaining structure 12 of the oropharyngeal appliance within the subject's mouth (e.g., a hook, mouthpiece, retainer, or crown), as shown in FIG. 1. However, the oropharyngeal appliance does not necessarily require a dental device, but may instead be anchored by a device, e.g., a spring, ring, or hook, that is at least partially located within the oropharyngeal appliance. The oropharyngeal appliance may also include other anchoring devices, such as, for example, one or more magnetic, hydraulic, or electrostatic devices.

[0032] The oropharyngeal appliance employs a mechanical design and is provided to prevent airway obstruction during sleep. The mechanical design keeps the airway open by preventing undesired collapse of soft tissue into the oropharynx. In some cases, the soft tissue may be the tongue. As the tongue muscles relax during sleep, the tongue tissue is drawn into the oropharynx by the negative pressure generated during inspiration, obstructing the airway. The mechanical device may prevent the tongue from moving backwards during inspiration into the oropharynx and obstructing the airway. It should be noted that although oropharyngeal appliances are always described that may be located behind the tongue in the oropharynx, other placement locations for the oropharyngeal appliance may be utilized, such as, for example, behind the soft palate in the nasopharynx. The oropharyngeal appliance does not necessarily have to be located behind the tongue, but may instead be located anywhere that is compatible with preventing pharyngeal collapse of the tongue.

[0033] 2 shows an example of a mechanical device, shown and described herein as oropharyngeal device 1, which includes a passive tongue-retaining structure 12 and an anchor structure 14 that retains the passive tongue-retaining structure 12 within the subject's mouth. The oropharyngeal device 1 can extend from an anchor point (a tooth as shown, or, for example, a portion of the gums, tongue or other desired anchor point) along the lingual surface of the mandible and / or above the upper surface of the tongue to prevent the tongue from falling down the throat, and ultimately be positioned behind at least a portion of the pharyngeal portion of the subject's tongue.

[0034] In some examples, the passive tongue-retaining structure 12 may be retained in a plane parallel to the mandible. In other examples, the passive tongue-retaining structure 12 may extend over the surface of the tongue. In other examples, the passive tongue-retaining structure may be located either above, below, or around the tongue, so long as at least a portion of the passive tongue-retaining structure 12 extends behind at least a portion of the subject's pharynx to prevent the pharynx of the tongue from collapsing into the throat. However, the passive tongue-retaining structure 12 does not necessarily have to be behind the tongue, but instead may be located in any location compatible with preventing the pharynx of the tongue from collapsing.

[0035] The oropharyngeal device 1 of FIG. 1 and the oropharyngeal devices 3 and 4 of FIG. 3 and FIG. 4 are the result of multiple design considerations. The passive tongue-retaining structure 12 must prevent the tongue from moving backwards into the oropharynx while allowing the tongue to move for swallowing. However, at least a portion of the passive tongue-retaining structure 12 must allow tongue movement but prevent the passive tongue-retaining structure 12 from moving upwards or downwards into the oral cavity or oropharynx. Also, that portion of the passive tongue-retaining structure 12 must not trigger a gag reflex and must not trigger excessive saliva (e.g., more saliva than would typically occur without the oropharyngeal device 1, 3, or 4).

[0036] On the one hand, the passive tongue retention structure 12 is primarily composed of thin wires (made of metal, polymer, organic material, etc.), which must be sufficiently stiff to prevent the tongue from deflecting. For example, the thickness and / or cross-sectional area of ​​the wires may not be constant. Also, the metal wires may have a cross-section that is circular, bent, rectangular, straight, flat, curved, or other shapes. The wires may be biocompatible to minimize irritation in the patient's mouth. Also, the wires may be durable and / or stable so that no part of the wire is displaced while the subject is sleeping. In some cases, the wires may be composed of metals and / or polymers that are themselves biocompatible or coated with biocompatible materials. As an example, the wires may have a flat orientation facing the tongue and cheeks, at least one wiggle through their length, and may have a band-like configuration (which eliminates the need for a spring as shown in FIG. 3). The passive tongue retention structure 12 can include terminal ends 16, which may be constructed of the same wire or different biocompatible materials. For example, the terminal ends may be arched.

[0037] Alternatively, the terminal end 16 can be adapted to restrain all or at least a portion of the subject's tongue. The passive tongue retention structure 12 is sized such that the terminal end 16 can prevent the posterior pharyngeal portion of the tongue from obstructing the subject's oropharynx during sleep without inducing a gag reflex, while allowing the tongue to move during swallowing. In some examples, the terminal end 16 can include at least a circular portion. In other examples, the terminal end 16 can have one or more bends.

[0038] As shown in FIG. 4, the terminal portion 16 can include an attachment structure 42 adapted to contact the posterior pharynx of the tongue. In some examples, the attachment structure 42 can be larger than the remainder of the passive tongue retention structure 12 to prevent the tongue from blocking the oropharynx. For example, the attachment structure 42 can be in the form of one or more coils made of the same or different biocompatible material as the wire of the passive tongue retention structure 12, an additional section of the same or different wire attached to the passive tongue retention structure 12, and / or a sheet of the same or different material as the wire. The attachment structure 42 can provide additional portions to prevent the tongue from moving backward into the oropharynx during inspiration and blocking the airway, as well as preventing gag reflex and excessive saliva production.

[0039] The anchor structure 14 can be adapted to removably secure the passive tongue retaining structure 12 to at least one of the subject's teeth or a portion of the subject's mandible. For example, the anchor structure 14 may include one or more rings for securing the oropharyngeal appliance 1 to one or more teeth and / or a portion of the mandible. In another example, the anchor structure 14 may include a magnetic body adapted to be attached to a reciprocating magnetic member that is connected to a portion of the subject's mouth. In some cases, as shown in the oropharyngeal appliance 3 of FIG. 3, the anchor structure 14 may include one or more springs 32. The one or more springs 32 may be adapted to permit tongue movement for swallowing. Although shown separately, it should be understood that in some examples, the one or more springs 32 and the mating structure 42 may be used together in other examples of the oropharyngeal appliance of the present disclosure.

[0040] 5 illustrates an alternative configuration of the oropharyngeal device 5 in which the passive tongue-retaining structure 12 loops or bends back to the anchor structure 14 to increase the strength of the passive tongue-retaining structure. In other words, the oropharyngeal device 5 may extend from the anchor point along the lingual surface of the mandible, contact the posterior pharyngeal portion of the subject's tongue behind at least a portion of the posterior pharyngeal portion of the subject's tongue, and then extend back along the lingual surface of the mandible and contact the anchor point again. In some examples, the passive tongue-retaining structure 12 may be retained in a plane parallel to the mandible. In other examples, a portion of the passive tongue-retaining structure 12 may extend beyond the upper surface of the tongue.

[0041] The oropharyngeal appliance 5 of FIG. 1 includes the oropharyngeal appliance 5 in FIG. 5 and the oropharyngeal appliances 6 and 7 in FIG. 6 and FIG. 7. Several design factors must be considered in FIG. 6 and FIG. 7. The passive tongue-retaining structure 12 must allow tongue movement for swallowing while preventing the tongue from moving backward into the oropharynx. However, at least a portion of the passive tongue-retaining structure 12 must be placed such that the passive tongue-retaining structure 12 does not cause the tongue to move upward or downward into the oral cavity or oropharynx. For example, a portion of the passive tongue-retaining structure 12 may be aligned with one or more of the subject's lower sharp teeth. Also, that portion of the passive tongue-retaining structure 12 must not cause a gag reflex and a large amount of saliva (e.g., more saliva than would typically occur without the oropharyngeal appliances 5, 6, or 7).

[0042] In the oropharyngeal device 5 of FIG. 5, the thickness, cross-sectional shape and / or stiffness of the passive tongue retention structure 12 must be well controlled to retain the tongue so that the tongue does not obstruct the oropharynx, while preventing the gag reflex, preventing the formation of excess saliva and allowing movement of the tongue for swallowing.

[0043] Another example of an oropharyngeal device 6 is shown in FIG. 6, which may include two or more springs 32a and 32b. Two or more springs 32a and 32b may allow for greater tongue movement for swallowing and may more firmly attach the passive tongue retention structure 12 to the anchor structure 14. FIG. 7 shows another example of an oropharyngeal device 7, which may include an attachment structure 42. Although two or more springs 32a and 32b and attachment structure 42 are shown separately, it should be understood that two or more springs 32a and attachment structures 42 may be used in the same oropharyngeal device. However, by way of example, to eliminate the need for springs 32a and 32b, the passive tongue retention structure 12 may have a band-like configuration with a planar orientation facing the tongue and cheeks and at least one rocker through its length.

[0044] 8 shows an alternative configuration of the oropharyngeal device 10 in which the passive tongue-retaining structure 12 includes a portion (terminal end 16) adapted to prevent the tongue from collapsing in the pharyngeal region. The passive tongue-retaining structure 12 extends between bilateral anchor structures 14a and 14b. The anchor structures 14a and 14b may attach the passive tongue-retaining structure 12 to one or more teeth on either side of the subject's mandible. However, at least one of the anchor structures 14a and 14b may be attached to a portion of the subject's mandible itself. Alternatively, at least one of the anchor structures 14a and 14b may be attached to a portion of the subject's tongue.

[0045] In some examples, the passive tongue-retaining structure 12 may be retained in a plane parallel to the mandible. In other examples, a portion of the passive tongue-retaining structure 12 may extend over the top of the tongue. In further examples, the tongue-retaining structure may extend above, below, or around the tongue in any configuration that prevents a portion of the passive tongue-retaining structure 12 from collapsing the subject's tongue in the pharynx.

[0046] The oropharyngeal device 10 in FIG. 8 and the oropharyngeal devices 30-70 in FIGS. 9-12 have been considered through multiple designs. The passive tongue-retaining structure 12 must allow the tongue to move for swallowing and prevent the tongue from moving backwards into the oropharynx. However, at least a portion of the passive tongue-retaining structure 12 must prevent the passive tongue-retaining structure 12 from entering the oral cavity or oropharynx upwards or downwards due to the movement of the tongue. For example, a portion of the passive tongue-retaining structure 12 may be aligned with one or more of the subject's lower sharp teeth. However, the passive tongue-retaining structure 12 does not necessarily need to be aligned with the subject's lower sharp teeth. Also, the portion of the passive tongue-retaining structure 12 must not generate a gag reflex and not generate a large amount of saliva (e.g., more saliva than would typically occur in the absence of the oropharyngeal devices 30-70) when preventing the pharyngeal portion of the tongue from collapsing and entering the oropharynx. For example, the passive tongue retaining structure 12 may be a thin, stiff wire, an example of which is similar to that described for the oropharyngeal device 1.

[0047] On the one hand, each of the anchor structures 14a and 14b (FIG. 8) can be adapted to removably secure the passive tongue-retaining structure 12 to at least two teeth of the subject and / or the mandible of the subject. For example, each of the anchor structures 14a and 14b may include one or more rings for securing the oropharyngeal appliance 10 to two or more teeth, gums, tongue, and / or mandible. In another example, the anchor structures 14a and 14b may include a magnetic body adapted to be attached to a reciprocating magnetic member connected to a portion of the subject's mouth. In some examples, the oropharyngeal device 30 shown in FIG. 9 may include one or more springs 32a and 32b extending from the anchor structures 14a and 14b. Although one spring 32a or 32b is shown as part of anchor structures 14a and 14b, two or more springs can be connected to each of anchor structures 14a and 14b to allow greater tongue movement for swallowing and to more firmly attach the passive tongue retention structure 12 to anchor structures 14a and 14b.

[0048] On the other hand, the terminal portion 16 can be adapted to contact the posterior pharyngeal portion of the subject's tongue. The passive tongue-retaining structure 12 is sized such that the terminal portion 16 prevents the posterior pharyngeal portion of the tongue from blocking the subject's oropharynx during sleep without inducing a gag reflex, while allowing the tongue to move during swallowing. As shown in the oropharyngeal device 40 of FIG. 10, the terminal portion 16 may have a junction structure 42 disposed to contact the posterior pharyngeal portion of the tongue. In some examples, the junction structure 42 may have a larger cross-sectional area than the remainder of the passive tongue-retaining structure 12 to prevent the tongue from blocking the oropharynx. For example, the junction structure 42 may be in the form of one or more coils 62 as shown in FIG. 11. The junction structure 42 may be made of the same or different biocompatible material as the wire of the passive tongue-retaining structure 12. As another example, the junction structure 42 may be an additional portion of the same or different wire attached to the passive tongue-retaining structure 12. In another example, the joining structure 42 may include a sheet of material 72, shown in FIG. 12, which may be the same or different from the wire. The joining structure 42 may provide a surface area that is attached to prevent the tongue from moving back into the oropharynx during inspiration and blocking the airway, as well as preventing the gag reflex and excessive saliva production. In some examples, the joining structure 42 may be used in combination with the springs 32a and 32b in the oropharyngeal appliance.

[0049] As an example, the passive tongue retention structure 12 need not be straight as shown in the figure. Conversely, the passive tongue retention structure 12 may be slightly curved caudally. Also, the use of one or more springs 32a, 32b can be substituted with two grounded magnetic bodies slid into recessed grooves. Also, the device need not contact the back of the tongue, provided that one or more magnetic bodies are embedded in the tongue.

[0050] In some examples, the passive tongue retaining structure 12 of the oropharyngeal appliance may be closely mated with the anchor structure 14 or dental appliance including structure, as shown in the text with respect to Figures 1-12. In other examples, the oropharyngeal appliance described in the text with respect to Figures 1-12 may be closely mated with an anchor system of the dental appliance such that a portion of the oropharyngeal appliance is fixed in a predetermined anatomical location to form a system for preventing obstructive sleep apnea. The dental appliance may be, for example, a mouthpiece, a retainer, a dental crown, etc. The dental appliance may fit over at least a portion of the subject's mouth (e.g., at least a portion of the mandible). Also, in some cases, the dental appliance is removable from the subject's mouth.

[0051] FIG 13 illustrates an example system (similar to the system of FIG 1) for preventing sleep apnea. Advantageously, the system illustrated in FIG 13 can prevent the tongue from entering the oropharynx, which is desirable for patients suffering from obstructive sleep apnea and excessive snoring (which is usually considered a precursor to obstructive sleep apnea). The system illustrated in FIG 13 can have a predetermined gap of approximately 5-10% of the maximum distance between the wire and the teeth.

[0052] As shown in FIG. 13, the system may include a mouthpiece 148 for use on the lower jaw, a wire 146, two springs 142, an anchoring system at the ends of the springs, and an anchoring system and ring 144 for holding the wire. Additional features of the system may include a tube for holding the spring 142 and / or the wire 146 placed in the lower jaw, other parts that allow the tongue to better articulate, and / or a spring-loaded retractable system for removing the spring. In use, the system may be placed in the subject's mouth at night like a normal mouthpiece. The system is placed in the subject's mouth and securely attached to the lower teeth. The system may prevent any blockage due to the tongue muscles relaxing at the same time due to lack of muscle tension during sleep. The natural movement of the tongue into the oropharynx may be prevented by the spring 142 resisting the weight of the tongue. Thus, in some instances, the spring specifications may be adjusted to the mass of the subject's tongue so that the subject can swallow any saliva produced at any time. The system may be removed in the morning and cleaned in a manner similar to dentures.

[0053] IV. Method Another aspect of the disclosure may include a method 100 (FIG. 13) of fitting an oropharyngeal appliance (e.g., any oropharyngeal appliance as shown in FIGS. 1-12) to a subject's oral cavity. The method 100 may be used to personalize an oropharyngeal appliance for a particular subject. At 102, one or more images of the subject's oral cavity may be taken. The images may be taken in a number of different directions. The images may be taken using any type of two-dimensional or three-dimensional imaging modality that allows visualization of the oral cavity, including x-ray, CT, or MRI. An exemplary imaging modality may be a cone beam CT imaging modality. At 104, an oropharyngeal appliance may be manufactured based on the images. The mouthpiece may be manufactured using standard dental practices, such as, for example, acrylic or 3D printing based on one or more images of the subject's oral cavity. For example, the 3D printing may be based on the cone beam CT images. Dimensions may be collected from the images, including the maximum distance between the wire and the teeth and the corresponding gaps. At 106, an oropharyngeal appliance (or system) may be fitted to the subject's oral cavity. At this time, any necessary modifications can be made to the oropharyngeal device (or system).

[0054] It should be noted that the oropharyngeal appliance (or system) need not be tailored to a particular subject. In some examples, the oropharyngeal appliance (or system) may be sized based on some average mouth and / or tongue dimensions (e.g., anatomical averages for a particular subject population). Personalization may occur similar to step 106 of method 100. However, in other examples, personalization may occur in the subject's own home by adjusting one or more features of the oropharyngeal appliance (or system) based on personal comfort.

[0055] From the above description, those skilled in the art will recognize improvements, changes, and modifications that fall within the scope of the present invention and are intended to be encompassed by the appended claims.

Claims

1. a passive tongue support structure having a terminal end adapted to prevent collapse of the subject's tongue in the pharyngeal region; at least one anchor structure connected to the passive tongue-holding structure for releasably securing the passive tongue-holding structure within the subject's mouth while permitting movement; wherein said passive tongue retention structure is sized and dimensioned such that said terminal portions prevent obstruction of the oropharynx during sleep while allowing the tongue to move during swallowing without eliciting a gag reflex.

2. the passive tongue retaining structures extend bilaterally along opposing lingual surfaces of the mandible or above the surface of the tongue; 10. The oropharyngeal appliance of claim 1, wherein at least a portion of the passive tongue retention structure extends behind the tongue.

3. 10. The oropharyngeal device of claim 1, wherein the at least one anchor structure includes at least one of a spring portion, a hydraulic portion, a magnetic portion, or an electrostatic portion.

4. 10. The oropharyngeal device of claim 1, wherein the terminal end includes an interface structure adapted to further contact the posterior pharyngeal portion of the tongue.

5. the at least one anchor structure includes a magnetic body attached to a reciprocating magnetic member; 10. The oropharyngeal device of claim 1, wherein the reciprocating magnetic member is connected to a portion of the subject's mouth.

6. the at least one anchor structure further comprises a dental appliance that fits closely with the passive tongue retention structure; The oropharyngeal appliance of claim 1 , wherein the dental appliance comprises a hook, a mouthpiece, a retainer, or a crown.

7. 10. The oropharyngeal device of claim 1, wherein at least a portion of the passive tongue retention structure is coated with a biocompatible material.

8. 10. The oropharyngeal appliance of claim 1, wherein the passive tongue retention structure comprises at least one of a biocompatible metal, a biocompatible polymer, and an organic material.

9. an oropharyngeal device sized and dimensioned such that its terminal portion prevents a portion of the subject's tongue from obstructing the oropharynx during sleep without inducing a gag reflex, while allowing the tongue to move during swallowing; and an anchor structure adapted to closely mate with the oropharyngeal device to secure a portion of the oropharyngeal device in a predetermined anatomical location.

10. the oropharyngeal appliance includes a passive tongue retention structure; 10. The system of claim 9, wherein the passive tongue retention structure has the termination adapted to prevent pharyngeal collapse of the subject's tongue.

11. 10. The system of claim 9, wherein at least one of the anchor structure and the oropharyngeal appliance is removably secured to the subject's mouth.

12. The system of claim 9 , wherein the anchor structure includes at least one of a spring portion, a hydraulic portion, a magnetic portion, or an electrostatic portion.

13. 10. The system of claim 9, wherein the anchor structure is adapted to extend a portion of the oropharyngeal appliance along a lingual surface of the subject's mouth.

14. 10. The system of claim 9, wherein the anchor structure further comprises at least a portion of a dental appliance attached to at least a portion of the subject's mouth.

15. The system of claim 14 , wherein the dental appliance comprises a hook, a mouthpiece, a retainer, or a crown.

Images