Patent ID: 12251513

The Figures are exemplary only, and the implementations illustrated therein are selected to facilitate explanation. The number, position, relationship and dimensions of the elements shown in the Figures to form the various implementations described herein, as well as dimensions and dimensional proportions to conform to specific force, weight, strength, flow and similar requirements are explained herein or are understandable to a person of ordinary skill in the art upon study of this disclosure. Where used in the various Figures, the same numerals designate the same or similar elements. Furthermore, when the terms “top,” “bottom,” “right,” “left,” “forward,” “rear,” “first,” “second,” “inside,” “outside,” and similar terms are used, the terms should be understood in reference to the orientation of the implementations shown in the drawings and are utilized to facilitate description thereof. Use herein of relative terms such as generally, about, approximately, essentially, may be indicative of engineering, manufacturing, or scientific tolerances such as ±0.1%, ±1%, ±2.5%, ±5%, or other such tolerances, as would be recognized by those of ordinary skill in the art upon study of this disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The dental appliance disclosed herein, in various aspects, may be removably attached to at least a portion of the teeth of the user. The dental appliance disclosed herein, in various aspects, may enhance respiratory performance of the user by interaction with various anatomical features of the mouth, jaw, or face, and, thus, increase athletic performance of the user. In various aspects, the dental appliance may afford protection to the teeth, tongue, lips, mandible, or other anatomical features of the mouth, jaw, or face.

The design of the dental appliance, in various aspects, is such that, when the dental appliance is positioned in the mouth, with the individual biting down, the dental appliance stimulates the hypoglossal nerve (XII cranial nerve) causing the genioglossus (tongue protruding muscle) to protrude/contract in a forward motion. This forward contraction of the genioglossus results in an increased oropharynx opening in the throat (Garner, D. P. and McDivitt, E., Effects of mouthpiece use on airways openings and lactate levels in healthy college males. Compendium: A Supplement of Continuing Education in Dentistry, 30(2): 9-13 (2009) and Garner, D. P., Effects of various mouthpieces on respiratory physiology during steady state exercise in college-aged subjects. Gen Dent, 63, 30-34 (2015).

Thus, when a user starts exercising, he/she should breathe through the mouth, while biting down on the mouthpiece. This may result in a type of pursed lip breathing which has been shown to lower ventilation, while improving oxygen and carbon dioxide kinetics and lactate levels during and after endurance exercise. While exercising anaerobically (specifically resistance exercise), the user should clench down and breathe through his/her mouth. This has been shown to decrease cortisol levels post exercise (see study by Garner, Dudgeon, McDivitt and Scheett, The effects of mouthpiece use on gas exchange parameters during steady-state exercise in college-aged men and women. J Am. Dent. Assoc. 2011 142(9) 1041-1047 and Garner, D. P., Dudgeon, W. D., and McDivitt, E., The effects of mouthpiece use on cortisol levels during an intense bout of resistance exercise. Journal of Strength and Conditioning, 25(10): 2866-2871(2011).

As used herein, ventilation is the measure of air into and out of the lunges, and respiratory rate is the measure of the exchange of oxygen and carbon dioxide within the lungs. Specifically, ventilation is the defined as the liters per minute. Respiratory rate is defined herein as breaths per minute. Tidal volume is defined herein as the volume of air inhaled and exhaled during one breath.

Anterior, as used herein, refers to portions of the mouth proximate the front of the mouth for example, proximate the lips or the front incisors. Posterior, as used herein, refers to the back of the mouth, for example, proximate the 3rd molar (if present) or the pharynx. Mesial, as used here, refers to the midline of the mouth. The central incisors are usually located on either side of the mesial line or midline. For example, a structure that extends mesially may extend toward the mesial line or midline, and a structure that is positioned mesially may be positioned about the mesial line or midline. Axial, as used herein, refers to directions along a vertical axis of the body as, for example, generally defined by the spinal column.

The tongue is a complex collection of muscles and nerves that may be stimulated in various ways either directly or indirectly by the dental appliance. The tongue muscles may be divided functionally into protruder muscles that move the tongue blade in the anterior direction and retractor muscles that pull the tongue in the posterior direction toward the posterior pharyngeal wall. Protruder muscles include the extrinsic genioglossus, the intrinsic verticalis and transversus muscles. Retractor muscles include the extrinsic hyoglossus and styloglossus, and the intrinsic inferior and superior longitudinalis muscles. Stimulation of both the genioglossus and hyoglossus may cause depression of the tongue.

The tongue muscles are innervated by branches of the hypoglossal nerve, which is the twelfth cranial nerve. The hypoglossal nerve trunk bifurcates into large mesial and lateral branches as the hypoglossal nerve approaches the tongue muscles, with the mesial branch containing axons supplying the protruder muscles (both intrinsic and extrinsic muscles) and the lateral branch the retractors.

The hypoglossal motor nucleus receives both excitatory and inhibitory synaptic input from many brain regions. Direct inputs originate in the nucleus of the solitary tract, the majority of the reticular nuclei, the principal and spinal trigeminal nuclei, reticularis subcoeruleus, the caudal Raphe nucleus, and the Kolliker-Fuse nucleus. These regions, in turn, receive substantia nigra, the superior colliculus, and the mesencephalic trigeminal nucleus. Many of these regions modulate ventilatory drive, with the reticular formation containing the interneurons that link the central respiratory drive from the pre-Botzinger complex with the hypoglossal motor nucleus. Accordingly, the tongue including the tongue muscles may be connected to respiratory performance through the hypoglossal nerve, so that respiratory performance may be increased by stimulating the tongue or positioning the tongue in certain positions. Increased respiratory performance may reduce fatigue by reducing lactic acid formation, and increased respiratory performance may reduce cortisol levels, which may promote muscle healing and have other beneficial effect.

For example, pursing of the lips appears to correlate with contraction of the genioglossus including expansions or contractions of other tongue muscles thereby positioning the tongue anteriorly and downward toward the mandible. When engaging in pursed lips breathing, the subject purses their lips while breathing in and breathing out slowly. There are two types of pursed lips breathing with one being a decrease in respiratory rate and an increase in tidal volume and the other type of pursed lips breathing being one with a decrease in respiratory rate with no change in tidal volume. It has been found that subjects with chronic obstructive pulmonary disease (COPD) experienced a subsequent and significant reduction in respiratory rate with faster recovery when subjects with COPD practiced pursed lip breathing while exercising, so that pursed lips breathing may be associated with increased respiratory performance.

As noted above, pursed lip breathing may be correlated with the contraction of the genioglossus. Studies of the genioglossus have found that contraction of the genioglossus may cause dilation of the pharyngeal airway. Particularly, when the genioglossus is contracted (i.e. the tongue is pushed down toward the mandible and forward toward the anterior teeth), there is a subsequent relaxation of the pharyngeal area in the back of the throat. Thus, pursed lips breathing may cause contraction of the genioglossus muscle that, in turn, causes dilation of the pharyngeal airway, resulting in the observed increased respiratory performance with pursed lips breathing. Thus, a dental appliance that promotes pursed lips breathing may increase respiratory performance.

In addition, stimulation of the hypoglossal nerve at various locations by the dental appliance may cause contraction of the genioglossus that positions the tongue down and anteriorly thereby resulting in dilation of the pharyngeal airway and concomitant increased respiratory performance. Various stimulations of the hypoglossal nerve by the dental appliance may otherwise signal various other nerves, nuclei, or regions of the brain that may produce various physiological effects that increase respiratory performance. Genioglossus may include the genioglossus as well as other protruder and retractor muscles, and contraction of the genioglossus may include movement of the other protruder muscles or movement of the retractor muscles, as would be readily understood by those of ordinary skill in the art upon study of this disclosure.

A forward shift of the mandible such as may occur with the dental appliance implementations disclosed herein may increase the pharyngeal area. Applicant has found airway anatomical differences with various implementations of the dental appliance, specifically measuring the diameter and width of the oropharynx with computed tomography (CT) scans that demonstrated a 9% improvement in both the diameter and width when subjects used the dental appliance. (See Garner, D. P. and McDivitt, E., Effects of mouthpiece use on airways openings and lactate levels in healthy college males. Compendium: A Supplement of Continuing Education in Dentistry, 30(2): 9-13 (2009)). Although the mandibular displacement of that implementation of the dental appliance was not as pronounced as those with a sleep apneic device, a significant effect on oropharynx width occurred when using the dental appliance.

Finally, it was found that implementations of the dental appliance that allowed subjects to clench all their teeth evenly with vertical displacement and a level pressure distribution between all teeth resulted in increased respiratory performance.

In various aspects, the dental appliance may comprise two bodies received on either side of the mouth with the two bodies connected to one another by a connector. The bodies may be constructed of a plurality of material layers bonded or otherwise secured to one another in various ways. In general, the body portions of the dental appliance may be composed of one or more layers of materials. These materials may include ethyl-vinyl acetate (EVA); thermoplastic polyolefin, various ethylene-based elastomers; various hydrocarbon resins (which are may be combined with EVA, thermoplastic polyolefin, or various ethylene-based elastomers), polycaprolactone (which may be combined with EVA), low-density polyethylene, high density poly-ethylene, polycarbonate and/or various polymers, laminates and other materials that will be recognized by those skilled in the art upon review of the present disclosure. In certain aspects, the composite material may be a pre-laminated sheet including a layer of polycarbonate bound to a layer of polyester urethane which is available under the trade name Durasoft® from the Scheu Dental Co. located in Iserlohn, Germany. Typically, these materials may be selected with a durometer (hardness) of between about 70 A to about 96 A or between about 55 D and about 90 D.

As described herein, in various aspects, one of the material layers of the plurality of material layers is a bite pad, and another of the material layers is an occlusal pad. Various other material layer(s) may be interposed between the bite pad and the occlusal pad, and additional material layer(s) may be placed about the occlusal pad or about the bite pad, in various aspects. The dental appliance may be constructed, at least in part, of the bite pad bonded to the occlusal pad, and the bite pad with the occlusal pad bonded thereto forms at least a portion of the dental appliance. In various aspects, the bite pad may support the occlusal pad, may interact with other elements of the dental appliance, and may confer various mechanical properties upon the dental appliance. The bite pad may interact with the teeth, and, thus, may be configured with treads including other tooth grippable surface, and the bite pad may have a selected hardness as indicated, for example, by a Shore hardness value as measured by a durometer. In various aspects, the occlusal pad may engage the user's teeth to attach removably the dental appliance thereto, and the occlusal pad may be custom fitted to engage the user's teeth. The occlusal pad may have a selected hardness as indicated, for example, by a Shore hardness value.

The bite pad is composed of one or more bite pad materials. In various aspects, the bite pad material may include a mixture of styrene block copolymer and ethylene vinyl acetate (EVA). An exemplary styrene block copolymer is available as DYNAFLEX® part number G2782 from GLS Corporation, Thermoplastic Elastomers Division, 833 Ridgeview Dr., McHenry, Ill. 60050. EVA is available from a number of sources, such as the ELVAX® resins from Dupont Packaging and Industrial Polymers, 1007 Market Street, Wilmington, Del. 19898.

In various aspects, the bite pad material may include a mixture of a styrene block copolymer and a polyolefin elastomer. The polyolefin elastomer may be a copolymer of ethylene and octene-1. An exemplary copolymer is available as ENGAGE® from Dupont Canada, Inc., P.O. Box 2200, Streetsville, Mississauga, Ontario L5M 2H3.

The bite pad material may include, in various aspects, a mixture of a thermoplastic rubber, which includes thermoplastic elastomer and thermoplastic urethane, with a polyolefin elastomer. Exemplary thermoplastic rubbers are Santoprene® thermoplastic elastomer from Advanced Elastomer Systems, L. P., 388 South Main Street, Akron, Ohio 44311 and Kraton® thermoplastic elastomer from the Shell Oil Company, Houston, Tex. Kraton® includes astyrene-ethylenelbutylenes-styrene block copolymer. In various aspects, the bite pad material may include polypropylene part number AP6112-HS from Huntsman Corporation, Chesapeake, VA 23320. In various aspects, the bite pad material may include HD-6706 ESCORENE® Injection Molding Resin [a high density polyethylene] from ExxonMobil Chemical Company, P.O. Box 3272, Houston, TX.

The bite pad material of the bite pad, in various aspects, may have a durometer of at least 60 D to resist substantial deformation and retaining a substantially planar configuration between at least two cusps of the teeth of the user when the teeth of the user are clenched about the bite pad. In various aspects, the bite pad material of the bite pad may have a durometer of between about 60 D to about 90 D although this may vary. In some aspects, the bite pad material of the bite pad has a Shore A hardness of about 82.

The occlusal pad is composed of one or more occlusal pad materials. In various aspects, the occlusal pad material may be transformable between a pliable state and a non-pliable state. In the pliable state, the occlusal pad material of the occlusal pad may be shaped to conform to the teeth of the user. In the non-pliable state, the occlusal pad material of the occlusal pad generally retains its conformance to the teeth of the user as shaped when in the pliable state. In various aspects, the occlusal pad may be transformed between the pliable state and the non-pliable state by heating and cooling, respectively. For example, heating the occlusal pad material in warm water may allow the occlusal pad to be fitted to the user's teeth and, after having been fitted, the occlusal pad material may be cooled to the non-pliant state thereby capturing the fit of the user's teeth in the occlusal pad material. The occlusal pad material is transformed from the non-pliable state to the pliable state at a temperature tolerable by the user upon placement of the occlusal pad material in the pliable state within the user's mouth, in various aspects. The occlusal pad material may transform between the non-pliant and pliant state at a temperature greater than human body temperature but less than about 100° C., in various implementations.

In various aspects, the occlusal pad material of the occlusal pad includes a mixture of polycaprolactone. An exemplary polycaprolactone is Capra 6500 polycaprolactone from Perstorp, UK Limited, Warrington, Cheshire UK. In various aspects, the occlusal pad material of occlusal pad40includes a mixture of polycaprolactone and ethylene vinyl acetate (EVA) such as ELVAX®. In various aspects, the occlusal pad material of occlusal pad40includes ethylene vinyl acetate (EVA) alone, such as ELVAX®. In various aspects, the occlusal pad material of occlusal pad40includes a mixture of polycaprolactone and a polyolefin elastomer, and the polyolefin elastomer may be a copolymer of ethylene and octene-1. An exemplary copolymer is available as ENGAGE® from Dupont Canada, Inc., P.O. Box 2200, Streetsville, Mississauga, Ontario L5M 2H3.

FIGS.1A,1B and1Cillustrate an exemplary implementation of a dental appliance10. As illustrated inFIGS.1A,1B and1C, exemplary dental appliance10includes bodies20,22connected to one another by connector70. The dental appliance10, as illustrated inFIGS.1A,1B and1C, is formed as a generally U-shaped member, the curved portions of the “U” extends around anterior portions of the user's mouth as anterior portion16of dental appliance10, and the straight portions of the “U” extend from the anterior toward the posterior of the mouth with posterior ends15,17of dental appliance10. When dental appliance10is positioned in the mouth, dental appliance10defines a buccal-labial side12that is generally oriented toward the cheeks and/or lips of the user and a lingual side14that is generally oriented toward the user's tongue. Anterior portion16of dental appliance10is positioned anteriorly mesially, as illustrated in the Figures, and posterior ends15,17are positioned posteriorly in the mouth.

Connector70includes bumper80, and occlusal pads40,42include flanges90,92, in this implementation. Bodies20,22of exemplary dental appliance10include occlusal pads40,42bonded to bite pads30,32, respectively. As illustrated, side46of occlusal pad40is bonded to side36of bite pad30and side48of occlusal pad42is bonded to side38of bite pad32. Sides36,38, are generally oriented opposite to sides37,39of bite pads30,32, respectively, and sides46,48, are generally oriented opposite to sides47,49of occlusal pads40,42, in this implementation.

Occlusal pads40,42define occlusal pad channels56,58in sides47,49, respectively, in this implementation. In exemplary dental appliance10, occlusal pad channels56,58may removably engage teeth on opposing sides of the mandible generally in the posterior portion of the mandible. For example, occlusal pad channels56,58of dental appliance10engage the mandibular 1st bicuspid, mandibular 2nd bicuspid, mandibular 1st molar, mandibular 2nd molar, and mandibular 3rd molar on the right and left sides, respectively. Occlusal pad channels56,58may be fit to the user's teeth in order to conform to the shape of the user's teeth including interstices between the user's teeth. Note that the mandibular 3rd molars (left and right; i.e. wisdom teeth) may be omitted from the illustrations and discussion herein for clarity of explanation and because the mandibular 3rdmolars are frequently absent.

The occlusal pad channels56,58are elongated, as illustrated, and are generally oriented along the mesial-distal axis. The at least a portion of occlusal pad channels56,58may extend over one or more of the canines, premolars and/or molars on each side of the mouth. The occlusal pad channels56,58may be configured in shape of the teeth of the user. A channel occlusal surface57,59of occlusal channels56,58, respectively, contacts at least a portion of the occlusal surface of the teeth. The channel occlusal surfaces57,59may be configured to conform to a least a portion of the occlusal surface of the user's teeth and may be configured to conform to the surfaces of all of the teeth received in the occlusal channels56,58. To conform, typically, cavities will be formed in the channel occlusal surfaces57,59that correspond to at least the cusps of the occlusal surfaces of the teeth. In certain aspects, this may more evenly distribute the force from clenching or an impact over the occlusal surface of the teeth and, among other things, may also improve retention and fitment of dental appliance10.

When occlusal pad cannels56,58of occlusal pads40,42are engaged with the teeth of the mandible, sides47,49of occlusal pads40,42are oriented toward the gum of the mandible and sides37,39of bite pads30,32are oriented toward teeth of the upper jaw. The teeth of the upper jaw may engage with sides37,39of bite pads30,32, respectively. Sides37,39of bite pads30,32may include treads and so forth, and may otherwise be generally adapted to contact occlusal surfaces of posterior teeth of the upper jaw opposite to the mandibular teeth engaged with occlusal pad channels56,58of occlusal pads40,42.

Bite pads30,32may be of sufficient hardness to resist substantial penetration by the teeth and deformation as the teeth of the user are clenched about bite pads30,32. Bite pads30,32may be formed from a material such as, for example, high density polyethylene or polypropylene that may have a durometer of between about 60 D to about 90 D.

As illustrated inFIGS.1A,1B, and1C, body20and body22are connected to one another by connector70, so that connector70secures body20and body22to one another. Connector70may be formed of a variety of materials including those materials set forth herein as being suitable for use in occlusal pads or of other materials or combinations of materials, as would be recognized by those of ordinary skill in the art upon study of this disclosure.

Connector70may be configured to extend as an arch around either the lingual side, labial side, or both the lingual side and labial side of the anterior teeth of the user, in various implementations. In certain implementations, connector70may extend along or just below the gum line on dental appliance10, which is configured to be removably attached to the mandibular teeth.

Connector70and occlusal pads40,42may be formed as a unitary structure in some implementations such that connector70extends between occlusal pads40,42, as illustrated. In other implementations, connector70and bite pads30,32may be formed as a unitary structure, such that connector70extends between bite pads30,32. In still other implementations, connector70may be attached to bite pads30,32, occlusal pads40,42, or both bite pads30,32and occlusal pads40,42by, for example, various adhesives, mechanical connections, thermal bonding, and combinations thereof.

When dental appliance10is positioned in the mouth with occlusal pad channels56,58engaged with posterior mandibular teeth, connector70generally passes about labial portions of the anterior mandibular teeth of the user with side71of connector70biased against the anterior mandibular teeth, and side73of connector70is oriented labially (i.e. toward the lips). Note that side71of connector70is fit to the user's teeth, in this implementation, so that side71conforms to the shape of the user's teeth including the interstices between the teeth.

As illustrated inFIGS.1A,1B and1C, bumper80extends forth from side73of connector70generally mesially along connector70. Bumper80may be formed of the same material as connector70so that connector70and bumper80form a unitary structure, in some implementations. In other implementations, bumper80may be secured to connector70by, for example, adhesive, mechanical connector(s), or thermal bond(s), and bumper80may be formed of various materials, as would be recognized by those of ordinary skill in the art upon study of this disclosure. In yet other implementations, bumper80may be removably attachable to connector70to allow the user to either attach bumper80to connector70or remove bumper80from connector70as the user may desire.

Flanges90,92extend forth mesially from lingual side14of dental appliance generally along the straight portions of the “U,” as illustrated inFIGS.1A,1B and1C. Flange90extends mesially from body20with edge91of flange90being of a scalloped configuration, as illustrated. Similarly, as illustrated, flange92extends mesially from body22with edge93of flange92being of a scalloped configuration. When dental appliance10is engaged with the mandibular teeth, sides98,99of flanges90,92are oriented generally toward the palate, while sides96,97of flanges90,92are oriented generally toward the mandible. Flanges90,92are oriented so that sides98,99are set apart from the palate, in this implementation, resulting is no contact between flanges90,92including sides98,99, respectively, and the palate when dental appliance10is engaged with the mandibular teeth.

As illustrated, flanges90,92are somewhat wedge-shapes with the broad part of the wedge being where flanges90,92emerge from lingual side14of dental appliance10and flanges90,92then tapering to form edge91,93. In other implementations, flanges90,92may be more planar in shape with generally constant thickness between sides96,98and generally constant thickness between sides97,99. Flanges90,92extend mesially a distance sufficient to impinge upon the side of the tongue thereby compressing portions of the genioglossus while avoiding creating a gag response, the distance being specific to the anatomy of the user, in various implementations.

Edges91,93are formed along the side of flanges90,92that extend furthest in the mesial lingual direction. Edges91,93are sufficiently blunt (illustrated as being rounded but other implementations may have other shapes) so that edges91,93do not injure the tongue. The axial dimension of edge91,93is less than the axial dimension of bases20,22as given, for example, by the length between side39and side49or the length between lingual body edge133and side39.

Flanges90,92are exemplary, and flange as used herein may include protuberances, extensions, or structures that extend forth from the lingual side of the dental appliance and are configured to touch the tongue in order to stimulate the hypoglossal nerve of the tongue, for example, by compression of the genioglossus including other muscles or tissues of the tongue. The flanges90,92may stimulate the hypoglossal nerve by touching portions of the tongue enervated by thy hypoglossal nerve such as portions of the tongue along the side of the tongue. Flanges, such as flanges90,92, may have other shapes in other implementations. Edges91,93are exemplary, and edge as used herein may include portions of the flange that generally contact the tongue to stimulate the hypoglossal nerve.

The implementation of dental appliance10includes supports52(illustrated in phantom) that are imbedded within flanges90,92to support structurally flanges90,92. Flanges90,92may be of unitary construction with the occlusal pads40,42, so that flanges90,92are formed of the same material as occlusal pads40,42and molded around supports52. Supports52, in this implementation are cantilevered from bite pads30,32with support ends51of supports52secured to bite pads30,32. Supports52may be of unitary construction with bite pads30,32, or support ends51of supports52may be attached to bite pads30,32, for example, by adhesive. Supports52have a “T” shape at support ends53, but may have, for example, a “Y” shape, or other shape or combination of shapes, in other implementations. Various numbers of supports52may be included in various implementations of dental appliance10, or, in some implementations, supports52may be omitted entirely. In other implementations, flanges, such as flanges90,92, may extend lingually mesially from bite pads, such as bite pads30,32, and may be formed of the same material as the bite pads, or flanges may extend forth from other portions of a lingual side of a dental appliance, such as lingual side14of dental appliance10.

FIG.2illustrates dental appliance10received in the mouth and engaged with the mandibular teeth105of the user. As illustrated inFIG.2, tooth500a,500b,500c,500d,500e,500f,500gare the left mandibular 2nd molar, left mandibular 1st molar, left mandibular 211c1bicuspid, left mandibular 1st bicuspid, left mandibular cuspid, left mandibular lateral incisor, left mandibular central incisor, respectively. Tooth500h,500i,500j,500k,5001,500m,500n, are the right mandibular central incisor, right mandibular lateral incisor, right mandibular cuspid, right mandibular 1st bicuspid, right mandibular 2nd bicuspid, right mandibular 1st molar, right mandibular 2nd molar, respectively, as illustrated inFIG.2.

As illustrated inFIG.2, edge91of flange90is biased against at least portions of side110of the portion of the tongue100generally adjacent teeth500k,5001,500m,500non the right side of the mandible when body20of dental appliance10is engaged with the mandibular teeth. Edge93of flange92, as illustrated inFIG.2, is biased against portions of side112of the portion of the tongue100generally adjacent teeth500a,500b,500c,500don the left side of the mandible when body22of dental appliance10is engaged with the mandibular teeth.

The biasing of edges91,93of flanges90,92against at least portions of sides110,112, respectively, of tongue100may compresses the genioglossus along the side of the tongue or may otherwise physically touch the tongue to stimulate the hypoglossal nerve. Stimulation of the hypoglossal nerve by flanges90,92may cause contraction of the genioglossus that positions the tongue100anteriorly and lowered toward the mandible, which may result in dilation of the pharyngeal airway and, thus, increased respiratory performance. Scalloped edges91,93, as illustrated, may be more effective in stimulating the hypoglossal nerve than straight edges, as, for example, the scalloped edges may differentially compress the genioglossus or otherwise differentially stimulate the tongue. For example, peaks of the scallop shape may compress the genioglossus while the valleys of the scallop shape may compress the genioglossus a lesser amount than the peaks or may avoid compressing the genioglossus altogether. Edges, such as edges91,93, may have waved, straight, saw-tooth, or other configurations or combinations of configurations, in other implementations.

Occlusal pad channels56,58of bodies20,22engage teeth500k,5001,500m,500non the right side and teeth500a,500b,500c,500don the left side, respectively, as illustrated inFIG.2. Posterior ends15,17of bodies20,22are generally positioned posteriorly coincident with teeth500n,500aon the right and left side, respectively, as illustrated, and anterior portion16is positioned anteriorly about mesial line114. Anterior ends26,28of bodies20,22are positioned at or posterior to tooth500k,500d, respectively, when dental appliance10is received in the mouth of a user, as illustrated.

Note that the mandibular 3rd molars (left and right; (i.e. wisdom teeth) are omitted fromFIG.2both for clarity of explanation and because the mandibular 3rd molars are frequently absent. It should be understood that occlusal pad channels56,58of dental appliance10may engage the mandibular 3rd molars when the mandibular 3rdmolar(s) are present. Flanges90,92may generally extend in the anterior-posterior direction from the mandibular Pt bicuspid to the mandibular 3rdmolar when, for example, the mandibular 3rdmolars are present) or flanges90,92may generally extend in the anterior-posterior direction from the mandibular Pt bicuspid to the mandibular 2rdmolar, for example, when the mandibular 3rdmolar is absent. In various implementations, flanges90,92may extend in the anterior-posterior direction adjacent at least portions of one or more teeth selected from the mandibular 2nd molar500a,500n, mandibular Pt molar500b,500m, mandibular 2nd bicuspid500c,5001, mandibular Pt bicuspid500d,500k. In various implementations, edges91,93may extend in the anterior-posterior direction adjacent at least portions of one or more teeth selected from the mandibular 2nd molar500a,500n, mandibular Pt molar500b,500m, mandibular 2ndbicuspid500c,5001, mandibular Pt bicuspid500d,500k.

Connector70generally passes about buccal-labial portions of the anterior mandibular teeth of the user with side71of connector70biased against the anterior mandibular teeth, for example teeth500e,500f,500g,500h,500i,500j, and side73of connector70is oriented labially (i.e. toward the lips), as illustrated inFIG.2. Side71of connector70, as illustrated inFIG.2, is biased against the mandibular cuspid, the mandibular lateral incisor, and the mandibular central incisor on both the left and right sides.

As illustrated inFIG.2, side83of bumper80is biased against interior side121of lower lip120proximate mesial line114. Bumper80does not intrude between the lips but merely biases against the interior side121of lower lip120so that bumper80remains entirely within the mouth cavity. The biasing of bumper80against the lower lip120(and the upper lip in some implementations) stimulates the lower lip120(or both lips) causing the lips to purse. Bumper80may assume various shapes that promote the pursing of the lips. Pursing of the lips in response to stimulation by bumper80may cause contraction of the genioglossus thereby positioning the tongue100anteriorly and lowered toward the mandible, which may result in dilation of the pharyngeal airway and, thus, increased respiratory performance.

Portions of connector70extend posteriorly from lingual side66of tooth62to form anterior flange74with posterior end75. Anterior flange74may extend a distance T from the centerline of tooth62to posterior end75, as illustrated inFIG.3C, with tooth62selected, for example, from tooth500e,500f,500g,500h,500i,500j. Posterior end75is positioned to engage portions of the tongue100proximate tongue tip113in order to stimulate tongue100, as illustrated inFIGS.2and3C. Tongue tip113in the illustration is located generally along labial portions of tongue100, for example, along teeth500e,500f,500g,500h,500i,500j. Anterior flange74may be mesially symmetric, and anterior flange74may extend along connector70, for example, from the tooth500eto tooth500j, from tooth500fto tooth500i, or from tooth500gto tooth500h, in various implementations.

Engagement of anterior flange74including posterior end75or side78with portions of the tongue100proximate tongue tip113as well as the position of anterior flange74with respect to connector70may cause contraction of the genioglossus, and may, by the location of side78, position the tongue100anteriorly and lowered toward the mandible, which may result in dilation of the pharyngeal airway and, thus, increased respiratory performance.

It should be noted that stimulation of the lip(s), such as lip120, by bumper80and contraction of the genioglossus caused by stimulation of tongue100at various locations by flanges74,90,92all potentially implicate stimulation of the hypoglossal nerve including the trigeminal nerve (fifth cranial nerve), and various portions of the brain in communication with the hypoglossal nerve or the trigeminal nerve that may be associated with respiration. Thus, such stimulation of the tongue at various locations by flanges74,90,92as well as pursed lips breathing as provoked by bumper80may increase respiratory performance is other ways that may or may not be known at present.

FIG.3Aillustrates body22of dental appliance10engaged with mandibular tooth106, where mandibular tooth106may be selected, for example, from tooth500a,500b,500c,500d. As illustrated inFIG.3A, body22includes bite pad32, occlusal pad42, and flange92. Bite pad32is secured to occlusal pad42, and mandibular teeth, such as teeth500a,500b,500c,500d, are received in occlusal channel58of occlusal pad42, as illustrated. WhileFIGS.3A and3Band the attendant discussion are directed toward body22of dental appliance10for explanatory purposes, it should be recognized that body20of dental appliance10may be configured similarly to body22of dental appliance10. Also, while body20,22of exemplary dental appliance10includes bite pads,30,32bonded to occlusal pads40,42, respectively, it should be recognized that bite pads30,32or occlusal pads40,42may be comprised of multiple layers of materials. It should be further recognized that body20,22may include additional layer(s) of material(s) or combinations of materials that may impart various mechanical functionalities to bodies20,22. It should also be recognized that bite pads30,32and occlusal pads40,42may be of the same material to form a unitary structure, in certain implementations.

When the teeth are engaged in the occlusal channel58of dental appliance10, a buccal body edge131of body22is positioned above the gum line of the user, as illustrated. In other implementations, buccal body edge131may extend below the gum-line of the user, or portions of buccal body edge131may be above the gum-line while other portions of buccal body edge131may extend below the gum-line. In some implementations, the buccal body edge131may be generally proximate the occlusal surface of the teeth so that the buccal side of occlusal channel58is either de minimis or omitted entirely.

Similarly, lingual body edge133may be variously positioned above the gum-line, as illustrated. Lingual body edge133may extend below the gum-line or portions of lingual body edge133may be above the gum-line while other portions of lingual body edge133may extend below the gum-line, in various implementations. In some implementations, the lingual body edge133may be generally proximate the occlusal surface of the teeth so that the lingual side of channel58is either de minimis or omitted entirely.

Flange92, as illustrated, is of generally unitary construction with occlusal pad42, and support52is cantilevered from bite pad32to support flange92. Support end51of support52is attached to bite pad32, and support end53of support52has a “T” configuration, as illustrated, and support52lies internally within flange92. Edge93of flange92may be biased against the side112of the portion of the tongue100, for example, from about tooth500ato tooth500d. In other implementations, flange92may be of generally unitary construction with occlusal pad42, or flange92may be of unitary construction with one or more other layers interposed between bite pad32and occlusal pad42.

As illustrated inFIG.3B, body22is engaged with tooth500a,500b,500c,500d. From a top view (seeFIGS.1A,1B), bite pads30,32may have an oblong shape, a generally rectangular shape, a kidney shape, an oval shape, an egg shape or be otherwise shaped to extend along at least a portion of an occlusal surfaces of the teeth engaged with occlusal pad channels56,58and the opposing maxillary teeth. The bite pads30,32are generally configured to space the occlusal surfaces of opposing teeth when a clenching force is exerted on bodies20,22including bite pads30,32by the user.

As illustrated inFIG.3A, the width W of bite pad32may be selected to contact or otherwise provide support between opposing teeth. The width W may be either constant or variable along the length L of bite pad32, in various implementations. The width W of bite pad32may be at least as wide as the distance between the cusps of individual adjacent teeth and the cusps of the opposing maxillary teeth. In certain aspects, the width W may be as wide or wider than the width of the adjacent teeth or at least as wide as the spacing of the cusps of the teeth. Width W may range, for example, between about 5 mm and about 15 mm.

As illustrated inFIG.3B, the length L of the bite pad32is selected so that bite pad32extends along the teeth engaged with body22. Length L may range from about 10 millimeters to about 25 millimeters, in various implementations.

The thickness t from the occlusal surface of a tooth, such as tooth106, to side39of bite pad32, as illustrated inFIGS.3A,3B, generally establishes the distance the mandibular teeth will remain separated from corresponding maxillary teeth when the jaw is clenched or when the jaw receives an impact while dental appliance10is attached. The thickness t may be generally equivalent to the thickness of bite pad32, in various implementations.

As illustrated inFIG.3B, thickness t generally decreases by zlt from posterior end17to anterior end19to define a slope At/L. In various implementations, the slope, At/L may range from 1/100≤zlt/L≤ 1/20 In some implementations, the slope may be about At/L 0 meaning no slope or generally constant thickness t along length L.

The thickness t may vary from about 1 mm to about 2 mm, in some implementations. In various implementations, thickness t may be generally about 5 mm at posterior end17and about 4 mm at anterior end19. Thickness t may be generally in the range of about 2 mm to about 6 mm at proximal end17and thickness t may be generally in the range of about 1 mm to about 4 mm at anterior end19. Most specifically, the thickness t may range approximately from 1.7 mm to 2.2 mm, while the thickness t at the anterior end19to side39of bite pad32at the anterior end19may range between approximately 0.7 mm to 1.2 mm. In some implementations, the thickness t may approach 0.00 millimeters (e.g. an edge) at the anterior end19. In various implementations, the bite pads slope, for example with 1 mm anterior end19increasing gradually in slope to 2 mm posterior end17. Note that, in implementations without a bite pad, such as bite pad32, length L, width W, thickness t, and slope At/L may be defined in reference to such implementations in ways as would be readily recognized by those of ordinary skill in the art upon study of this disclosure.

The slope At/L may enhance forward protrusion of the mandible (jaw) due to the biting down on these bite pads, the lack of material on the backside of the front bottom teeth, and the material on the inside of the dental appliance which aids in pushing the tongue in and forward, in such implementations.

The bite pads30,32elevate and create a minimal opening so that the individual may clench on the dental appliance and breathe through the mouth. If the thickness t too large, dental appliance10may not properly stimulate the hypoglossal nerve in ways that result in a pushing down and forward motion of the tongue, so that the dental appliance10fails to function properly. If the thickness t too large, a pressing down of the tongue by dental appliance10may not occur. In various other implementations, the thickness t may be between about 0.25 millimeter and about 2.5 millimeters. Bite pads30,32may have a constant thickness with respect to length, a varying thickness with respect to length, or either a constant or varying thickness along the width.

The effects of dental appliance10use on respiratory performance may be related, at least in part, to the even contact between occlusal surfaces and bite pads30,32, which may be promoted by the slope At/L. The slope At/L may allow all teeth to contact bite pads30,32equally at maximal intercuspal positions. Laboratory results seem to indicate that differences in the evenness of contact between teeth, along with varying vertical dimensions have resulted in different outcomes (Garner, 2015). (See: Murakami, S., Maeda, Y., Ghanem, A., Uchiyama, Y., & Kreilborg, S. Influence of mouthguard on temporomandibular joint. Scand J Med Sports, 18, 591-595 (2008); Pae, A., Yoo, R., Noh, K, Pake, J., & Kwon, K The effects of mouthguards on the athletic ability of professional golfers. Dent Traumatol, 29, 47-51 (2013))

For example, the slope of bite pad32, as illustrated inFIG.3B, along with a similar slope of bite pad30may cause a forward displacement of the mandible that may improve respiratory performance by increasing the pharyngeal area. In particular, the slope of bite pads30,32may allow all the teeth in contact with bodies20,22to be clenched more or less evenly with minimal vertical displacement between the mandibular teeth and the maxillary teeth. This may release the temporal mandibular joint allowing more forward displacement of the mandible resulting in increased respiratory performance.

FIG.3Cillustrates a portion of connector70in engagement with tooth62selected from tooth500f,500g,500h,500i. As illustrated inFIG.3C, side73of connector70is oriented labially, and side71of connector70is oriented lingually to be in biased engagement with labial side64of tooth62, tip69of tooth62, and a portion of lingual side66of tooth62proximate tip69. As illustrated inFIG.3C, anterior flange74may extend a distance T from the centerline of tooth62to posterior end75of anterior flange74. Anterior flange74defines sides78,79, and channel81is defined by side78to receive one or more teeth, such as tooth62, as illustrated. In various implementations, T may generally range from about 10 mm to about 30 mm. In various implementations, T may be about 12 mm. In various implementations, T may be either constant or may vary along the length of anterior flange74.

Anterior flange74engages tongue tip113in various ways to stimulate the hypoglossal nerve. As illustrated, tongue tip113of tongue100is in contact with posterior end75of anterior flange74and with side78of anterior flange74, which may cause positioning of the tongue down and anteriorly resulting in dilation of the pharyngeal airway and concomitant increased respiratory performance.

FIG.4Aillustrates a portion of connector142of exemplary dental appliance140in engagement with, for example, tooth147selected from tooth500e,500f,500g,500h,500i,500j. Side141of connector142is biased against labial side148of tooth147to the tip149of tooth147, in this implementation, with tip149not covered by connector142.

FIG.4Billustrates an implementation of dental appliance150including a portion of connector170in engagement with, for example, tooth162selected from tooth500e,500f,500g,500h,500i,500j. As illustrated inFIG.4B, side173of connector170is oriented labially, and side171of connector170is in biased engagement with labial side164of tooth162, tip169of tooth162, and a portion of lingual side166of tooth162proximate tip169. Accordingly, tip169of tooth162is covered by connector170, in this implementation.

FIGS.5A and5Cillustrates connector70. Side71of connector70, which is biased against labial sides of anterior mandibular teeth, such as tooth107, conforms to the shapes of the anterior mandibular teeth, in this implementation. As illustrated, side71of connector70includes recesses77within which sides of the anterior mandibular teeth are received, such as labial side108of tooth107, and side71of connector70includes crests76that intrude into interstices between teeth. As illustrated inFIG.5C, connector70is of generally constant width along its length. Anterior flange74including posterior end75extends along mesial portions of connector70, as illustrated. Anterior flange74may extend posteriorly along connector70to a greater or lesser extent, in various other implementations.

FIGS.5B and5Dillustrates connector170of dental appliance150. Side171of connector170, which is biased against labial sides of anterior mandibular teeth, such labial side164of tooth162, is generally smooth so as not to conforms to the specific shapes of the anterior mandibular teeth, in this implementation. As illustrated inFIG.5C, connector170is of varying width along its length that generally conforms to the shape of labial anterior portions of the user's mouth.

FIGS.6A,6B, and6Cillustrate an exemplary implementation of a dental appliance200. The dental appliance200, as illustrated inFIGS.6A and6B, is formed as a generally U-shaped member, the curved portions of the “U” extends around anterior portions of the user's mouth and the straight portions of the “U” extend from the anterior toward the posterior of the mouth. Dental appliance200defines a buccal-labial side212that is generally oriented toward the cheeks and/or lips of the user and a lingual side214that is generally oriented toward the user's tongue300when the dental appliance200is positioned in the mouth. As illustrated inFIGS.6A,6B and6C, exemplary dental appliance200includes bodies220,222connected to one another by connector270. Anterior segment216of dental appliance200is positioned anteriorly and posterior ends215,217are positioned posteriorly mesially symmetrically with respect to one another in the mouth when dental appliance200is received in the mouth of the user, in this implementation.

As illustrated inFIGS.6A and6B, bodies220,222of exemplary dental appliance200include occlusal pads240,242bonded to bite pads230,232, respectively. As illustrated, side246of occlusal pad240is bonded to side236of bite pad230, and side248of occlusal pad242is bonded to side238of bite pad232. Sides236,238, of bite pads230,232are generally oriented opposite to sides237,239of bite pads230,232, respectively, and sides246,248of occlusal pads240,242are generally oriented opposite to sides247,249of occlusal pads240,242, in this implementation.

In the implementation ofFIGS.6A and6B, occlusal pads240,242define occlusal pad channels256,258in sides247,249, respectively. Occlusal pad channels256,258may removably engage posterior maxillary teeth on opposing sides of the maxillae to removably attach dental appliance200to the maxillary teeth. For example, occlusal pad channels256,258of dental appliance200may engage the maxillary Pt bicuspid, maxillary 2nd bicuspid, maxillary 1″ molar, maxillary 2nd molar, and maxillary 3rdmolar (when present) on the left side and right side, respectively. Occlusal pad channels256,258may be fit to the users teeth in order to conform to the shape of the users teeth including interstices between the user's teeth. The dental appliance may be removably attached to various maxillary teeth, in various implementations.

When occlusal pad cannels256,258of occlusal pads240,242are engaged with maxillary teeth, sides247,249of occlusal pads240,242are oriented toward the maxillary gums and sides237,239of bite pads230,232are oriented toward the mandibular teeth. The mandibular teeth may engage with sides237,239of bodies220,222, respectively, which may include treads and so forth, and may otherwise be generally adapted to engage the mandibular teeth.

As illustrated inFIGS.6A and6B, body220and body222are connected to one another by connector270. Side271of connector270is oriented lingually and side273of connector270is oriented buccal labially, as illustrated, when dental appliance200is positioned in the mouth. Connector270generally passes about buccal-labial portions of the anterior maxillary teeth of the user with side271of connector270biased variously against the anterior maxillary teeth and anterior maxillary gums, and side273of connector270is oriented labially (i.e. toward the lips), in this implementation.

As illustrated inFIGS.6A,6B, flanges290,292extend forth in lingual mesial directions from lingual side214of dental appliance200generally along the straight portions of the “U,” as illustrated inFIGS.6A and6B. Flange290extends lingually toward the mandible from body220with edge291of flange290being of a scalloped configuration, as illustrated. Similarly, as illustrated, flange292extends lingually toward the mandible from body222with edge293of flange292being of a scalloped configuration. When exemplary implementation of dental appliance200is engaged with the maxillary teeth, sides298,299of flanges290,292are oriented generally toward the palate while avoiding contact with the palate, while sides296,297of flanges290,292are oriented toward the mandible while avoiding contact with the lingual frenulum root of the tongue, or other anatomical structures axially below the side of the tongue.

In various implementations, flanges290,292may be of unitary construction with the occlusal pads240,242, so that flanges290,292are formed of the same material as occlusal pads240,242. In various implementations, flanges290,292may be of unitary construction with the bite pads230,232, so that flanges290,292are formed of the same material as bite pads230,232. Flanges290,292may extend forth from various portions of lingual side214of dental appliance200including various portions of body220,222, in various implementations.

As illustrated inFIG.6C, body220of dental appliance200is engaged with maxillary tooth306, where maxillary tooth306may be selected from maxillary teeth305including maxillary 1st bicuspid, maxillary 2′d bicuspid, maxillary 1st molar, maxillary 2′d molar, and maxillary 3rdmolar (when present) on the left side. Mandibular tooth216, as illustrated, is biased against side237of bite pad230, and mandibular tooth216is opposite maxillary tooth306. Mandibular tooth may be, for example, one of500a,500b,500c,500d(seeFIG.2). As illustrated inFIG.6C, body220includes bite pad230, occlusal pad240, and flange290. Bite pad230is secured to occlusal pad240, and maxillary tooth306is received in occlusal channel256of occlusal pad240, as illustrated.

Edge291of flange290may be biased against at least portions of side310of the portion of the tongue300, for example, adjacent maxillary tooth306. Edge293of flange292may be biased against portions of side310of tongue300, as illustrated inFIG.6C. Sides310,312of tongue300may be generally adjacent mandibular teeth from the mandibular 1st bicuspid to the mandibular 3rdmolar (when present) along the left and right sides, respectively. The biasing of edges291,293of flanges290,292against at least portions of sides310,312, respectively, of tongue300may stimulate the hypoglossal nerve causing contraction of the genioglossus so that the tongue is positioned anteriorly and lowered toward the mandible, which may result in dilation of the pharyngeal airway and, thus, increased respiratory performance.

FIGS.7A and7Billustrated implementations of dental appliances400,450having various exemplary arrangements of flanges432,442,462,472,482that interact with the tongue, inter cilia, to stimulate the hypoglossal nerve in order to cause forward contraction of the genioglossus that may result in an increased oropharynx opening in the throat. Other arrangements or numbers of flanges, such as flanges74,90,92,290,292,432,442,462,472,482, may be disposed in various ways about the dental appliance, for example, to stimulate the hypoglossal nerve of the tongue at various locations by contacting the tongue in order to prompt forward contraction of the genioglossus, in various implementations.

FIG.7Aillustrates portions of dental appliance400including flange432with edge433, flange438with flange439, and flange442with edge443. Flanges432,438,442are connected with other structures of dental appliance400that have been omitted fromFIG.7Afor clarity of explanation. As illustrated inFIG.7A, edge433of flange432biases against side410of tongue405to stimulate the hypoglossal nerve generally proximate teeth500b,500c. Edge439of flange438biases against side412of tongue405to stimulate the hypoglossal nerve, as illustrated, generally proximate teeth5001,500m. Edge443of flange442biases against tongue tip413of tongue405generally proximate teeth500g,500h(the mandibular central incisors) to stimulate the hypoglossal nerve. Note that edges433,439,443have a curvature that conforms generally to the corresponding curvature of the tongue.

FIG.7Billustrates portions of dental appliance450including flange462with edge463, flange472with edge473, flange482with edge483, flange486with edge487, and flange492with edge493. As illustrated, flanges462,472,482486,492are connected with other structures of dental appliance450that have been omitted fromFIG.7Bfor clarity of explanation. Edges463,473,487,493of flanges462,472,486,492bias against corresponding sides456,457,459,461of tongue455to stimulate the hypoglossal nerve at these locations, and edge483of flange482biases against tongue tip458to stimulate the hypoglossal nerve proximate tongue tip458. Side456is proximate teeth500a,500b, side457is proximate teeth500c,500d, side458is proximate teeth500f,500g,500h,500i, side459is proximate teeth500k,5001, and side461is proximate teeth500m,500n, as illustrated. Flanges462and472are, for example, in spaced relation to one another as are flanges486,492, in this implementation. Note that edges463,473,487,493have a concave shape so that only portions of edges463,473,487,493contact tongue455, in this implementation.

FIG.9illustrates portions of dental appliance600including base620attached removably to tooth601, with tooth601being a mandibular tooth selected, for example, from500a,500b,500c,500d. Flange690, as illustrated inFIG.9, extends forth from lingual side of dental appliance by length693to impress edge691of flange690into tongue609a length697. Length693is measured from lingual side602of tooth601to edge691of flange690, as illustrated. Length697, as illustrated, may be sufficient to compress the transversus linguae613, the styoglossus611, or both the transversus linguae613and the styoglossus611that, in turn, causes forward contraction of the genioglossus617. Tongue609is illustrated in cross-section at a location along the along the anterior-posterior dimension. Depending upon the anterior-posterior positioning of flange690, edge691may impress into the hyoglossus.615a length, such as length697, sufficient to compress the hyoglossus615that, in turn, causes forward contraction of the genioglossus617. Note that the hypoglossal nerve innervates the transversus linguae613, the styoglossus611, the hyoglossus,615and the genioglossus617, so that the transversus linguae613, the styoglossus611, the hyoglossus615, and the genioglossus617communicate with one another via the hypoglossal nerve and by physical interconnections, as illustrated inFIG.9. Accordingly, impressment of flange690onto one or more of the transversus linguae613, the styoglossus611, the hyoglossus615, and the genioglossus617may cause positioning of the tongue down and anteriorly resulting in dilation of the pharyngeal airway and concomitant increased respiratory performance. The flange690has length, such as length693, to impress into one or more of the transversus linguae613, the styoglossus611, the hyoglossus615, and the genioglossus617to cause positioning of the tongue down and anteriorly resulting in dilation of the pharyngeal airway and concomitant increased respiratory performance, in various implementations.

As illustrated inFIG.9, base620includes bite pad630and occlusal pad640bonded to one another. Flange690is formed unitarily with occlusal pad640, in this implementation. The length699between sides696,698is greatest where flange690emerges from occlusal pad640gradually diminishing toward edge691with edge691being rounded. Flange690has a bell shape, in this implementation. Other implementations of the flange, such as flange690, may be bell shaped and skewed. Still other implementation of the flange, such as flange690, may have a constant length between sides, such as length699, to have a generally constant cross-sectional shape such as a rectangular cross-sectional shape. Length699is less than the length between side641and side643of occlusal pad640, as illustrated.

Experiment 1

Various commercially available dental appliances and modifications of the commercially available dental appliances were tested in vivo in Experiment 1. These tests are labeled R1-R5 and are described as follows:R1—No dental applianceR2—Wedge mouthpiece with reverse 4 mm in the back of mouth and 2 mm in the front, inside portion is missing, no contact with the tongueR3—Under Armour® boil and biteR4—Altered Under Armour® boil and bite with the inside portion missing, no contact with the tongueR5—Similar to R2 with a reverse 4 mm in the back of the mouth and 2 mm in the front and instead of a slope there is a noticeable 1 mm step in the middle of the increase from front to back, lingual portion of dental appliance is missing, no contact with the tongue.

Two exemplary configurations of the dental apparatus according to the present disclosure were tested in vivo in Experiment 1. These are labeled and described as follows:DG proto*—generally similar to the exemplary dental appliance10including flanges90,92generally posterior on dental appliance10. Does not include anterior flange74.DG tong*—generally similar to the exemplary dental appliance10including flanges90,92generally located on posterior portions of dental appliance10. Includes anterior flange74that may push the tongue down slightly thereby placing the tongue in optimal position to increase airway opening. * the numbers 1 & 2 refer to specific tests.

In Experiment 1, the subject ran 5 minutes on a treadmill with the dental appliance inserted in the subject's mouth. Then, the respiratory rate of the subject was measured using a True Max metabolic cart manufactured by Parvo Medics, Inc., Sandy, Utah immediately following the 5 minute run on the treadmill, The same subject tested each of the dental appliances. The tests occurred on different days, so that the subject had sufficient time to recover physically between tests. The subject was, of course, in good physical condition. Results for the various dental appliances are illustrated inFIG.8

As illustrated inFIG.8, the measured respiratory rates for the subject using dental appliances R1-R5 ranged from about 38 BPM to about 42 BPM (Breaths Per Minute). The measured respiratory rate for the subject using dental appliance DG prototype were 29.8 BPM and 31.3 BPM. The measured respiratory rate for the subject using dental appliance DG tong were 28.6 BPM and 32.3 BPM.

Thus, these experimental results indicate that respiratory rate decreased by as much as 13 BPM when dental appliances DG prototype and DG tong were used by the subject from the respiratory rates exhibited when the subject either used no dental appliances R1 or when the subject used dental appliances R2-R5. The decrease in respiratory rate using dental appliances DG prototype and DG tong is indicative of increased respiratory performance resulting from use of dental appliances DG prototype and DG tong.

In operation, the dental appliance, such as dental appliance10,140,150,200,450, may be received in the mouth of the user in removable attachment to one or more teeth, such as tooth500a,500b,500c,500d,500k,5001,500m,500n, or various maxillary teeth such as maxillary molars and maxillary bicuspids. The dental appliance may be removably attached to various combinations of teeth in various implementations.

With the dental appliance removably attached within the mouth of a user, one or more flanges, such as flange74,90,92,290,292,432,438,442,462,472,482,486,492,690may contact the tongue, such as tongue100,300,405,455,609to stimulate the hypoglossal nerve of the tongue at various locations in order to prompt forward contraction of the genioglossus. Forward contraction of the genioglossus may result in dilation of the pharyngeal airway and concomitant increased respiratory performance. The hypoglossal nerve may be stimulated at various locations around the tongue including the side of the tongue and proximate the tip of the tongue, and flanges may be provided at various locations about the dental appliance to so stimulate the hypoglossal nerve by contact with the tongue.

A bumper, such as bumper80, may stimulate the lip or lips to provoke pursed lip breathing that may increase respiratory performance. Wedge shaped bite pads, such as bite pads30,32, may position the jaw in ways that increase respiratory performance.

Various stimulations of the lips, the hypoglossal nerve, positioning of the jaw, and combinations thereof by the dental appliance may increase respiratory performance by other as yet unrecognized physiologic responses.

The foregoing discussion along with the Figures discloses and describes various exemplary implementations. These implementations are not meant to limit the scope of coverage, but, instead, to assist in understanding the context of the language used in this specification and in the claims. The Abstract is presented to meet requirements of 37 C.F.R. § 1.72(b) only. This Abstract is not intended to identify key elements of the apparatus and methods disclosed herein or to delineate the scope of this disclosure. Upon study of this disclosure and the exemplary implementations herein, one of ordinary skill in the art may readily recognize that various changes, modifications and variations can be made thereto without departing from the spirit and scope of the inventions as defined in the following claims.