Sleep correction device wires and lamps

Abstract

A habit correction device including a first ramp and a second ramp extending from the front. The first ramp is positioned adjacent to or high on the palate of the user to ensure that the tongue is properly positioned. The second ramp is positioned lower and directly below the first ramp, the second ramp substantially prevents the tongue from entering the lower space in the oral cavity, and the first ramp helps to elevate the tongue position so that the patient learns to swallow with the tongue elevated to prevent mouth breathing. Slits on the sides of the ramps allow for lateral expansion of the device. Lingual tabs promote proper forward positioning of the jaw. Lingual wires with narrower anterior wire extensions can provide arch expansion and movement of the anterior position of the upper incisors and maxilla.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 17 / 361,713, entitled "WIRE AND RAMPS IN SLEEP HABIT CORRECTOR," filed June 29, 2021, the disclosure of which is incorporated herein by reference.

[0002] The present invention relates to oral appliances for children and adults. More particularly, the present invention relates to one or more oral appliances used to address abnormal sleep problems in children and adults. [Background technology]

[0003] The statements in this section are merely intended to provide background information related to the present disclosure and should not be construed as constituting prior art.

[0004] Habits such as thumb or finger sucking, poor tongue position, abnormal swallowing, and tongue protrusion contribute to sleep problems that can have serious consequences on the patient's health. For example, a poorly positioned tongue within the mandibular body can cause children to develop a narrow posterior maxillary arch. This can prevent nasal volume development and reduce the amount of air passing through the nasal area. Mouth breathing becomes a common way for these individuals or users to breathe.

[0005] Thumb or finger suction also displaces the tongue, causing it to misalign in the palate. Children typically swallow twice per minute during the day and once per minute while sleeping. This represents approximately 1,920 swallows every 16 hours during the day and 480 swallows while sleeping, or 2,400 swallows per day. Mouth breathing habits can easily develop with these types of abnormal practices. Mouth breathing is strongly associated with brain function, the immune system, and growth changes (not only in the face but also internally). These patterns affect the body to have more frequent infections (enlarged tonsils and adenoid tissue), further exacerbating the problem.

[0006] Mouth breathing also causes the jaw and tongue to move backward at night, opening half an inch during sleep, which tends to narrow the oropharynx by about 6 millimeters (mm). This reduces the child's oxygen supply, which has serious implications for the brain, immune, and endocrine systems. This explains why children with sleep-disordered breathing can suffer from neurocognitive, behavioral, and social problems.

[0007] Therefore, there is a need for oral appliances that can help children or adults address abnormal sleep problems, thereby improving their health.

[0008] The present invention is intended to improve upon and overcome some of these known shortcomings in the art. Summary of the Invention [Problem to be solved by the invention]

[0009] The habit corrector substantially prevents, corrects, or ameliorates the following problems and provides the following advantages:

[0010] Prevents posterior movement of the mandible and tongue during sleep, relieving oropharynx obstruction.

[0011] The tongue is repositioned to place itself on the palate and away from the mandibular body.

[0012] Mouth breathing is substantially prevented, forcing the patient to breathe through the nose.

[0013] Reduce or correct thumb sucking.

[0014] Reduce or correct anterior open bite.

[0015] The mandible is moved forward to achieve a proper anteroposterior relationship with the maxilla.

[0016] Stimulates condylar growth in receding mandibles (micromandibular)

[0017] Reduce or correct abnormal occlusion.

[0018] Reduce or prevent tongue thrust. [Means for solving the problem]

[0019] The device includes a handle for pulling the device anteriorly and strengthening the orbicularis oris muscle (around the lips) as needed.

[0020] Expands the posterior arch.

[0021] These and other features of the habit correction device are shown and identified in the accompanying drawings of the device.

[0022] In one embodiment, a habit correction device is provided that includes a first ramp and a second ramp. The first ramp extends from the front of the device, and is an upper ramp that is positioned adjacent to or high on the user's palate to orient the tongue to be positioned on the palate, thereby expanding the palate and further preventing or reducing mouth breathing due to the lower tongue position preventing mouth breathing during the day. The second ramp extends from the front of the device, and is a lower ramp that is positioned lower and directly below the first ramp to substantially prevent the tongue from invading the lower portion of the oral cavity. The first ramp helps elevate the tongue position so that the patient learns to swallow with the tongue elevated, substantially reducing or preventing air from entering the oral cavity through the mouth.

[0023] In another embodiment, a habit corrector is provided that includes an inner wall spaced apart from an outer wall and one or more lower lingual tabs extending from the inner wall, the one or more lingual tabs configured to reduce the tendency of the mandible to slide backward and increase mandibular forward movement during sleep to promote mandibular growth.

[0024] In a further embodiment, a method is provided for using a mouth correction device having upper and lower recesses by relining the upper and lower recesses with a self-hardening acrylic or similar material to securely secure the device to the mouth and substantially prevent habitual mouth breathing.

[0025] In a further embodiment, a method is provided for applying to a patient a habit correction appliance having an upper recess with an upper inner shield and a lower recess with a lower inner shield, the method including: changing a shape of the upper recess by adjusting a wire structure disposed in the upper inner shield, the wire structure including a curved portion disposed between relatively straight ends; and placing the appliance having the changed shape in the patient's mouth and expanding the patient's dental arch disposed in the upper recess by moving an anterior extension toward the upper recess to move the upper incisors and maxilla forward.

[0026] In one or more embodiments, slits are placed in the lateral portions of both ramps of the posterior margin to allow for easy expansion of the maxillary posterior arch.

[0027] In a further embodiment, there is an embedded wire (0.030"-0.045" diameter) that runs from the anterior to the posterior of the device around the lingual arch.

[0028] The embedded wires have longitudinal undulations or curves in the posterior (back) region to allow for better expansion of the dental arch in either the maxillary or mandibular arch.

[0029] Three front wire extensions, between 0.015 inches and 0.028 inches, extend upward from the main front wire to advance the front teeth and maxilla in an anterior direction. Other numbers of front wire extensions are contemplated. [Brief explanation of the drawings]

[0030] The above-mentioned aspects of the present application and the manner of obtaining them will become more apparent, and the teachings of the present application will be better understood, by referring to the following description of embodiments of the present application in conjunction with the accompanying drawings, in which:

[0031] [Figure 1] FIG. 2 is a top perspective view of the habit correction device. [Figure 2] FIG. [Figure 3] FIG. [Figure 4] FIG. 10 is another rear view of the habit correction device. [Figure 5] FIG. 2 is a side cross-sectional view taken along the longitudinal centerline of the habit correction device. [Figure 6] FIG. 2 is a schematic rear view of the habit corrector. [Figure 7] 10 is another embodiment of a back view of a habit correction device. [Figure 8] FIG. 1 is a perspective view of one embodiment of a wire embedded in a habit corrector. [Figure 9] FIG. 10 is a perspective view of another embodiment of a wire embedded in a habit corrector. [Figure 10] 8 is a side cross-sectional view taken along the longitudinal centerline of another embodiment of the habit correction device of FIG. 7. [Figure 11] 1 shows a process chart for determining symptoms, severity, and indicators of sleep-disordered breathing when determining treatment recommendations.

[0032] Corresponding reference characters indicate corresponding parts throughout the several views. While the exemplifications set forth herein illustrate embodiments of the present application in some forms, the embodiments disclosed below are not intended to be exhaustive or to limit the scope of the present application to the precise forms disclosed. DETAILED DESCRIPTION OF THE INVENTION

[0033] While illustrative embodiments incorporating the principles of the present disclosure are disclosed herein, the present disclosure is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Further, this application is intended to cover departures from the present disclosure that come within known or customary practice in the art to which this invention pertains.

[0034] The disclosed habit correction device is primarily used passively at night for individuals with abnormal sleep problems. The accompanying drawings provide an understanding of various design features. The disclosed device is primarily worn passively at night while sleeping to encourage the patient or individual to breathe through the nose and reduce nighttime mouth breathing. The habit correction device addresses abnormal sleep problems in children (and adults) and the habits and growth factors that may be known to affect such problems. Figure 1 shows both upper and lower ramps, with the upper ramp guiding the tongue as far as possible to the palate, while the lower ramp prevents the tongue from assuming a resting position within the mandibular body.

[0035] FIG. 1 shows a habit corrector 10 including a high, upper outer shield 12, also identified as a labial shield, for substantially preventing a patient from gaining air through the oral cavity when opening their mouth. The habit corrector comes in different sizes to accommodate different sized mouths and engages both upper and lower teeth. The high, upper outer shield 12 extends upward from a recess 14 configured to fit the upper teeth, resulting in the upper teeth being bounded by the outer shield 12, the recess 14, and the inner shield 16. At the posterior upper portion 18 of the device 10, the lateral distance D between the outer shield 12 and the inner shield 16 increases, providing a wider recess, particularly toward the lingual side of the tongue. The upper edge 20 of the outer shield 12 is higher than the upper edge 22 of the inner shield 16, which is defined corresponding to the surface of the recess 14. The upper edge 22 of the inner shield 16 extends from the recess 14, lower than the upper edge 20 of the outer shield 12, providing a high lingual margin to maintain the sides of the tongue in position between the opposing upper edges of the inner shield. The upper edge 22 at the location of the rear ridge 23 is higher than the upper edge of the wall 32 from which the one or more projections 32 extend.

[0036] As used herein, "anterior" refers to the portion of the appliance configured to be placed on the anterior teeth. The appliance defines a central longitudinal line extending from the anterior teeth toward the posterior teeth and extending from anterior to posterior along a centerline.

[0037] FIG. 1 further illustrates a posterior portion of the cavity 14, including an upper posterior cavity 28 and a lower posterior cavity 30, as seen in FIG. 3. The upper cavity 28 is configured to receive the teeth of the upper jaw, and the lower cavity 30 is configured to receive the teeth of the lower jaw. In one embodiment, the lower posterior cavity 30 is lined with a self-curing acrylic resin that substantially prevents the jaws from separating during sleep, particularly at night. The upper posterior cavity 28, in one or more embodiments, also includes a self-curing acrylic resin disposed in the cavity 14. Materials other than self-curing acrylic resin are contemplated, including heat-softenable overlays. Additional materials include, but are not limited to, methyl methacrylate, ethyl methacrylate, ethylene vinyl acetate (EVA), or a thermal plastic elastomer (TPE). The use of self-curing acrylic resin holds the jaws together in a closed occlusion, reducing or preventing tongue impaction against the oropharynx. The dual new lining of the upper and lower halves of the device (upper and lower recesses) helps prevent jaw flaring, which can lead to mouth breathing. Having both the upper and lower halves of the device newly lined substantially prevents mouth breathing from occurring and becoming a habit. In one or more embodiments, the resin is relatively hard and is not typically replaced with new resin. If new lining is needed, the user may do so. The upper recess 14 and lower recess 30 may be textured to increase adhesion to the liner, even in the interior recesses, if desired.

[0038] One or more protrusions 32 extend from the wall 33 of the inner shield 16 toward the rear of the device to substantially prevent the tongue from protruding forward and reduce the likelihood of tongue protrusion, facilitating proper swallowing. In other embodiments, protrusion areas extend from the side walls of the inner shield instead of or in addition to the protrusions 32. The protrusions 32 extend into the lingual portion of the maxillary arch.

[0039] 1 also shows the high posterior lingual margin defined by the upper edge 22 of the inner shield 16, which enters the interdental area with the liner and enters the lingual soft tissue on the side of the hard palate, increasing appliance retention and preventing opening. In another embodiment, shown in FIGS. 4 and 5, the likelihood of removal of the appliance 10 is reduced, and the appliance 10 includes an archwire 34 molded with the appliance. In one embodiment, the archwire 34 is a single thick wire. In another embodiment, multiple wires are molded with the appliance.

[0040] The outer shield 12 includes an upper labial shield 35 and a lower labial shield 37 (see Figures 1, 3, 4, and 6), each of which is higher toward the front of the device 10 to reduce or prevent mouth breathing and encourage nasal breathing. The labial shield 35, which has height A in Figure 6, and the labial shield 37, which has height B in Figure 6, are heights that are tolerable to patients of different ages, such as 1-2 years old, 3-5 years old, 6-8 years old, 9-12 years old, and 13 years old, as well as adults. These upper and lower labial shields must be as high as possible to fit the oral cavity of these different ages. This is important because when a patient opens their mouth to admit air into the oral cavity and oropharynx, their tongue strikes the anterior wall of the oropharynx, collapsing it and reducing air (oxygen) to the lungs. These shields also prevent mouth breathing and replace mouth breathing with normal nasal breathing.

[0041] Table 1 below shows the height ranges for Height A and Height B for different age groups. However, the height ranges shown are exemplary, and Height A and Height B should not be limited to these specific heights. Patient-specific heights are accommodated by decreasing the height or increasing the height for each age group by a distance of approximately 5 mm in either direction.

[0042] [Table 1]

[0043] The anterior margin 20 of the outer shield 12, in different embodiments, is much higher than the posterior lingual margin 22 of the inner shield 16. The posterior buccal margin 21 (part of the upper edge 20) is approximately the same height as the posterior lingual margin 22. These posterior lingual margins 22 serve a different purpose than the upper anterior shield 35 and the lower anterior shield 37, but rather to prevent mouth breathing and thumb sucking. The posterior margins 21 and 22 are intended to secure new linings in the interproximal areas between the canines and posterior teeth to prevent removal of the appliance 10 and to keep the jaws firmly together, preventing jaw expansion that could allow undesirable mouth breathing.

[0044] The new lining is the addition of a separate hard plastic, a self-hardening acrylic, such as methyl methacrylate or ethyl methacrylate, that flows into the embrasure of the teeth, most often the posterior upper and / or lower teeth. The purpose is to securely fasten the appliance to the teeth and prevent it from falling out of the mouth or opening the mouth as the upper and lower teeth are newly lined with such material. In some cases, the acrylic can be replaced by a dental professional, but this is not common.

[0045] Table 2 below shows height ranges for the anterior margin 20 and posterior lingual margin 22. However, the height ranges shown are exemplary, and therefore the heights should not be limited to those in Table 2. For example, base element 22 is 1.4 times taller than element number 20 for ages 2-4, but 2.6 times taller at adult height. While these heights are exemplary and generally acceptable for many patients, these distances may differ significantly from those in Table 2 in different embodiments. The third column of Table 2 shows the ratio of the height of element 20 compared to element 22.

[0046] [Table 2]

[0047] As seen in FIGS. 2 and 3 , the device 10 includes one or more lower lingual tabs 36 extending from the lower edge of the inner shield 16. In FIG. 3 , the lower lingual tabs 36 extend longitudinally toward the rear of the recess 14 and downward from the front of the recess 14 to encourage anterior (forward) positioning of the mandible and prevent it from sliding backward during sleep. This increases the success of treating mouth breathing and mandibular advancement, which can reduce oxygen to the body, and prevents airway restriction, which can reduce oxygen to the body by increasing pressure against the anterior wall of the oropharynx. The lingual tabs 36 are positioned below the lower ramp or shelf 42 to maintain oropharynx opening. In one or more embodiments, these tabs 36 are 6-10 mm long—approximately 3-7 mm longer than the tabs of currently known sleep apnea correctors—ensuring maximum mandibular advancement, oropharynx opening, and improving correction of nighttime mouth breathing.

[0048] The maxillary posterior lingual tab or protrusion 32 (see FIG. 4) includes a small protrusion that reminds the child where the tongue belongs when swallowing. The other posterior protrusion 23 (shown as a circle) in FIG. 1 is intended to direct where the tongue should be positioned, thereby protruding the tongue and expanding the palate. The protrusion 23 is located on the lingual surface of the lingual palatal tab 22. In one or more embodiments, there are typically three of these protrusions, located on the lingual surface of the palatal tab. Other numbers of protrusions 23 are contemplated. The protrusion 32 has also been identified as a maxillary protrusion that reduces tongue protrusion.

[0049] As seen in FIGS. 1 and 3 , the device 10 includes a first ramp or shelf 40 and a second ramp or shelf 42 extending toward the rear of the device. The first ramp 40 is larger than the second ramp 42 and includes a terminal edge 44 that extends farther toward the rear of the device than the terminal edge 46 of the second ramp 42. As also seen in FIG. 1 , the first ramp 40 is higher relative to the second ramp 42 and is therefore closer to the palate than the second ramp 42. The larger, longer first ramp 40 on the maxilla encourages the tongue to elevate into the palate, while the smaller, shorter second ramp 42 on the mandible substantially prevents and discourages the tongue from resting on the mandibular body. There is sufficient space between the bottom of the first ramp 40 and the top of the second ramp 42 to reduce or prevent the tongue from intruding anywhere beneath the first ramp, i.e., anywhere located beneath the first ramp 40. In another embodiment, there may be a connection between the two lamps 40 and 42 .

[0050] The positions of the first ramp 40 and the second ramp 42 are also shown in Figures 2 and 4. The upper ramp 40 is very high, almost inside the palate, to ensure that the lower part of the tongue learns to position itself on the palate, expanding the palate and preventing mouth breathing during the day and night. The lower ramp substantially prevents the tongue from invading the lower part of the oral cavity. The upper ramp 40 helps elevate the tongue position so that the patient learns to swallow with the tongue elevated. This position also substantially prevents air from entering the oral cavity, which can cause mouth breathing.

[0051] Slits 47 and 48 are located on both sides of ramps 40 and 42 in FIG. 1 to allow for unrestricted expansion or contraction of posterior sections 28 and 30. An embedded wire 15 (see FIGS. 4 and 8) having a longitudinally oriented wave structure 49 is disposed within the material forming device 10. Wave structure 49 extends longitudinally from a relatively straight baseline and includes generally rounded peaks. The body of the maxillary arch is adjusted by moving sections 28 and 30 in FIGS. 1 and 3 toward or away from each other. By spacing sections 28 and 30 further apart, the physical expansion of the maxillary arch is increased. In other embodiments, the wave structure includes generally square-shaped and periodic peaks, such as a square wave. Other embodiments are contemplated, including a wire extending longitudinally along inner shield 16 and a wire extending longitudinally along inner shield 16. In another embodiment, a wire, such as wire 15, is disposed in an inner shield disposed in lower recess 30.

[0052] An additional wire 50 of smaller diameter, i.e., 0.020 inches, is attached to the main embedded wire 15 in some embodiments, as seen in FIGS. 7 and 9. Other wire sizes are contemplated. The wire 50 includes longitudinal corrugations 51, which may have, for example, three extension wires bent upward to fit within the palate. The wire 50 and longitudinal corrugations are embedded in plastic tabs 53 (see FIG. 7), each of which extends upward from the lingual side of the device when manually bent forward toward the back of the upper teeth. As the tabs 53 are moved into position behind the teeth, the maxilla and incisors are moved forward over a period of time. See FIGS. 7 and 8. Wire-embedded tabs are used in devices that allow the maxilla and upper incisors to be easily moved forward without any interference from the labial shield. FIG. 10 shows the wire 15 including the corrugations 51 of the wire 50 positioned within the inner shield 16. In true cross-section, the wire 15 with the corrugations 49 is not shown. In this FIG. 10, the oriented wave structure 49 and wire 15 are shown to indicate their approximate position relative to the shield 16.

[0053] The buccal posterior margin is also increased to hold the appliance more securely in place and prevent jaw expansion. The buccal posterior margin on the upper shield 35 is shown by edge 21 in FIG. 1 and in the lower shield by edge 37 in FIG. 3.

[0054] FIG. 5 is a side cross-sectional view of the habit correction device along the longitudinal centerline. As seen in FIG. 5, the upper ramp or shelf 40 and the lower ramp or shelf 42 are spaced apart to maintain tongue position. The larger, longer first ramp 40 on the upper jaw elevates the tongue, while the smaller, shorter second ramp 42 on the lower jaw substantially prevents and discourages the tongue from resting on the lower jaw. The lingual tab 36 is positioned on the tongue on the lower shelf 42. The shelf 40 guides the tongue upward toward the palate, but the shorter shelf 42 prevents the tongue from finding a resting position within the mandibular body. The tongue rests on the top of the shelf 40, preventing the patient from breathing through the mouth. The shelf 40 may also be slightly curved downward in the middle of the shelf for more tongue comfort. The lingual tab 36 extends downward longer and more efficiently, preventing the mandible from sliding backward during sleep. This also prevents the mandible from moving away from the oropharynx, preventing the oropharynx from collapsing.

[0055] Further embodiments are described below, which generally describe methods for making an apparatus, but the resulting devices having the described features are also contemplated.

[0056] As disclosed herein, one embodiment of a habit corrector includes forming a first recess and a second recess, each lined with a material that reduces the likelihood of jaw flaring, thereby reducing the prevention of mouth breathing.

[0057] In another embodiment, a method is provided for providing a correction device including a wire with an embedded wavy wire structure, such as a longitudinal curve, where the wavy wire structure is molded into a lingual portion of the habit correction device, the wire structure extending from an application surface, e.g., near the back left side, to the other side of the device, e.g., near the back right side.

[0058] In a further embodiment, a method is provided for providing an orthodontic appliance having a wire that includes an embedded wavy wire structure, wherein the embedded wire structure is bendable while the wire retains its shape once bent into a desired position. The bendable wire allows the user to change the shape of the appliance to widen or narrow the distance between the sides, thereby changing the width of the maxillary arch.

[0059] In the same or other embodiments, a habit correction device is provided that has a bendable wire embedded in the lower arch of the device to allow the user to change the shape of the device to increase or decrease the distance between the sides, thereby changing the width of the lower arch.

[0060] In another embodiment, a method for preparing a habit corrector with an upper shelf, a lower shelf, or both an upper shelf and a lower shelf, where the shelf is not directly connected to the sides of the device but is separate from the sides to facilitate increasing or decreasing the lateral distance between the sides. Once the distance is set by the user, the embedded wire maintains its shape in the newly selected position until further manipulation of the wire.

[0061] In a further embodiment of the habit corrector, the method includes preparing the habit corrector, wherein the upper and lower walls of the front of the device are extraordinarily tall to prevent mouth breathing and stimulate nose breathing, even when the mouth is open. For example, in one or more embodiments, "extraordinarily tall" is considered to be approximately a 25% increase over the values ​​shown in Table 2 above. These dimensions are shown in Table 3 below, each dimension in millimeters. The columns are identified as columns A and B in Table 3, and FIG. 6 sets forth the recommended amounts for height 20 in FIG. 1 and height 41 in FIG. 2, with a 25% increase marked in columns A(+25%) and B(+25%). Height A 20 and height B 41 are found in Table 3 below.

[0062] [Table 3]

[0063] In another embodiment, a method for implanting appliances with bendable wires is provided, the appliances being a habit corrector, a Max A appliance, and a Class III appliance. The Max A is an appliance that moves the upper incisors and maxilla forward to an anterior (forward) position relative to the mandible. This movement is accomplished by three extending tabs attached to an upper lingual anterior shield. Tongue pressure against the three tabs pushes the maxillary arch (teeth and bone) forward due to the absence of a labial shield in the Max A (or Class III appliance).

[0064] The Class III appliance has the same upper portion as the Max A, but has a bumper on the lower posterior portion of the lower shield, which applies posterior pressure against the lower dentition. The Max A corrects mid-facial retrusion, while the Class III appliance corrects mandibular prognathism (anterior mandible) combined with treatment of maxillary retrusion (anterior mandible).

[0065] Other embodiments include methods of making devices with embedded wires that include additional wires attached to a main wire with various configurations that address other objectives, such as advancing the upper jaw and upper teeth. The additional wires attached to the main wire are, in some embodiments, thinner than the main wire, the same size as the main wire, or thicker than the main wire. In other embodiments, the additional wire features are included in a single main wire that includes various thicknesses or diameters.

[0066] In a further embodiment, there is a method for making a device that includes an embedded wire with a curved portion at the posterior portion of the base wire with an additional wire of smaller diameter having multiple taller extensions that exert pressure on the upper jaw and upper anterior teeth to move the upper jaw and upper anterior teeth forward when embedded in the device by pushing these wire extensions forward.

[0067] To determine or diagnose sleep-disordered breathing, one or more sleep questionnaires are used, depending on the patient's age. The most frequently used sleep questionnaires are for 5-7 year olds, but they can also be used for individuals aged 8-12. Each questionnaire provides a symptom list in the form of questions. Responses to the questions are used to determine whether a sleep-disordered breathing device is recommended for the patient. In one embodiment, assessments are conducted at an initial time before the patient begins using the sleep-disordered breathing device, and at a subsequent or second time after a period of time, such as six months, to determine the effectiveness of the device and the persistence of improvement or relapse, which may occur even after subsequent times, even months and years.

[0068] FIG. 11 illustrates one embodiment of an example flowchart 58 for determining or diagnosing sleep-disordered breathing, used alone or in combination with a sleep questionnaire. If a sleep questionnaire is not used, the determination can be made by the practitioner. If a questionnaire is used, first, in block 60, the patient completes a sleep vocalization questionnaire, which includes several questions to be answered and, upon completion, provides treatment recommendations. These questions cover one or more of the following symptoms: snoring, abnormal speech, labored breathing, consonant omission, intermittent snoring, nasal or hoarse voice, hyperactivity, incontinence, mouth breathing, frequent interruptions, morning headaches (AM), frequent infections, allergies, teeth grinding, excessive sweating, light sleep, sleepwalking, attention deficit, difficulty with school, and nighttime waking. Each of these symptoms is present in one or more of the age-related questionnaires, but other symptoms may be included as needed. In one or more embodiments, each symptom is also characterized based on the severity of the symptom. For example, in different embodiments, severity is rated based on a scale of 0 to 5. Other scales are contemplated. A severity rating of 0 represents absence, 1-2 (approximately 1-2 times per week) is mild severity, 3 is moderate severity (occurring approximately 3-4 times per week), and 4-5 is marked severity (present almost constantly, 5-7 nights per week).

[0069] Once the questionnaire is completed, it is reviewed to determine the number of symptoms, symptom severity, and index. The index is a value determined by adding the number of symptoms and the cumulative total severity. The cumulative total severity is determined by adding the severity values ​​identified for each of the symptoms. See block 60. Once the index is determined, different treatment recommendations are made based on the questionnaire results. In this embodiment, there are treatment levels identified as Grade 1 in block 62, Grade 2 in block 64, Grade 3 in block 66, Grade 4 in block 68, and Grade 5 in block 70. Fewer or more grades are contemplated. As seen in each of the blocks, treatment is recommended based on severity. Each of the blocks also represents the symptom value, severity, and index needed to provide a treatment recommendation and the need for treatment.

[0070] For example, no treatment is required as seen in Grade 1 (Block 62) or there is a slight need for treatment as seen in Block 72. Furthermore, for certain types of single symptoms such as Types 4, 5, 6, 9, 10, 25 and ADHD, treatment is recommended in Block 74. See Table 4 below.

[0071] [Table 4]

[0072] Each of blocks 64, 66, 68, and 70 includes a recommended treatment and treatment needs, as shown in corresponding blocks 76, 78, 80, and 82. As can be seen in FIG. 11, blocks 76, 78, 80, and 82 recommend treatment with a sleep habit corrector, each with a different need ranging from a mild need in block 76 to a very strong and pronounced need in block 80. For Grade 5, in block 70, mandatory treatment is recommended, and the need is considered severe. If treatment is recommended, the recommended type of treatment is provided to the patient by the practitioner or directly to the patient by computerized artificial intelligence. In different embodiments, the treatment needs include the number of daytime treatment sessions and the amount of time the device will be in place for each treatment session. Treatment can include a proposed treatment that is strictly adhered to, a proposed treatment that is adjusted by the practitioner or computer, or a treatment that is designed by the practitioner or computer based on the results of a completed individual survey.

[0073] While illustrative embodiments incorporating the principles of the present disclosure have been described herein, the present disclosure is not limited to such embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Further, this application is intended to cover departures from the present disclosure that come within known or customary practice in the art to which this disclosure pertains.

Claims

1. A habit correction device, a first ramp extending from the front of the device, the first ramp including a top, a bottom, and a first terminal edge extending toward the rear of the device, the first ramp being an elevated upper ramp configured to elevate and guide the user's tongue toward an elevated tongue position at the top of the upper ramp adjacent to or on the roof of the user's palate, orienting the user's tongue to be positioned higher near the roof of the palate, thereby enlarging the palate and also preventing or reducing mouth breathing due to the higher position of the lower part of the tongue preventing mouth breathing during the day or night; a second lamp including a top portion and a second terminal edge extending toward the rear portion of the device, wherein: the first and second terminal edges have the same profile in cross section; the first terminating edge is not directly connected to the second terminating edge, the first terminating edge extends further towards the rear of the device than the second terminating edge, such that the second ramp is smaller and shorter than the first ramp, the second ramp extends from the front of the device, the second ramp is a lower ramp located below and directly below the first ramp, and defines a first space between the first terminating edge at the bottom of the first ramp and the second terminating edge at the top of the second ramp, the first space being configured to prevent the tongue from being located at any position below the first ramp; the second ramp is configured to prevent the tongue from entering a lower portion of an oral cavity space within the oral cavity and to prevent the tongue from assuming a resting position within the mandibular body; when the device is worn, the first ramp helps elevate the tongue position so that the user learns to swallow with the tongue elevated, reducing or preventing air from entering the oral cavity through the mouth; the front portion includes an outer shield and an inner shield spaced apart from the outer shield; The stabilizing device, wherein the first ramp and the second ramp extend from the inner shield.

2. 2. The habit correction device of claim 1, wherein the outer shield defines a first recess with the inner shield configured to receive a tooth of the user's upper jaw and a second recess with the inner shield configured to receive a tooth of the user's lower jaw.

3. 3. The habit corrector of claim 2, wherein the first recess and the second recess are lined with a material to reduce the likelihood of jaw flaring, thereby reducing or preventing mouth breathing.

4. 4. The habit correction device according to claim 3, wherein the first recess and the second recess are configured to be newly lined with a resin material that prevents the occurrence and habituation of mouth breathing.

5. 5. The habit correction device of claim 4, wherein the inner shield includes a wall extending upward from the first recess, the wall including a first side facing the first recess and a second side facing a second space of the habit correction device configured to receive the tongue, and one or more posterior ridges are disposed on the wall of the inner shield to remind the user of the proper position of the tongue when swallowing.

6. 6. The habit correction device of claim 5, further comprising one or more lingual tabs extending from the anterior portion toward the posterior portion of the device to encourage an anterior positioning of the mandible, prevent the mandible from sliding backward during sleep, and resist occlusion by the mandible and tongue resulting from posterior movement, thereby increasing the success of treatment for mouth breathing, mandibular forward movement, and maintaining oropharyngeal openness.

7. A habit correction device as described in claim 4, wherein at least one of the first recess, the second recess and the shield is textured to promote retention of the resin material.

8. 3. The habit correction device according to claim 2, further comprising one or more slits disposed between lateral edges of both the first ramp and the second ramp to provide enlargement of both the first recess and the second recess, wherein the lateral edge of the first ramp is not directly connected to the lateral edge of the second ramp.

9. A habit correction device as described in claim 1, wherein the first lamp is bent downward toward the rear of the device.

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