Device and method for promoting nasal breathing and reducing mouth breathing during sleep

Abstract

FIELD: medical equipment.SUBSTANCE: group of inventions relates to medicine, in particular to devices and a method for facilitating nasal breathing and reducing mouth breathing during sleep. The device includes a front portion, a first ramp, and a second ramp extending from the front portion of the device. The first ramp is located near the user's palate and is designed to direct the tongue toward the palate. The second ramp is located below and beneath the first ramp, wherein the second ramp is configured to block the passage of the tongue into the lower part of the oral cavity, and the first ramp is configured to maintain the raised position of the tongue during swallowing. A method for providing a patient with a device for promoting nasal breathing and reducing oral breathing during sleep, which device has an upper channel with an upper internal barrier and a lower channel with a lower internal barrier, includes adjusting a wire structure in the upper internal barrier to change the shape of the upper channel and placing the device with the changed shape in the oral cavity of the patient to expand the dental arch of the patient.EFFECT: possible to promote nasal breathing and reduce oral breathing during sleep, prevent the lower jaw and tongue from shifting backward during sleep, eliminate oropharyngeal obstruction, and correct bite.23 cl, 11 dwg, 4 tbl

Description

Link to related applications

[0001] This application claims priority to non-provisional U.S. patent application Serial 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 in its entirety.Technical Field

[0002] The present invention relates to an oral appliance intended for both children and adults. More specifically, the present invention relates to one or more oral appliances that are used to solve sleep problems in children and adults.Background of the invention

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

[0004] Habits such as thumb or finger sucking, incorrect tongue positioning, improper swallowing, and tongue protrusion contribute to sleep problems, which can have a serious impact on a patient's health. For example, incorrect tongue positioning within the body of the mandible when resting results in a narrow posterior zygomatic arch. This, in turn, does not stimulate nasal volume and can reduce the amount of air passing through the nasal area. Mouth breathing becomes the default breathing pattern for such patients or users.

[0005] Thumb sucking or finger sucking also causes the tongue to shift from its proper position on the roof of the mouth. Typically, a child swallows twice per minute during the day and once per minute while sleeping. This amounts to approximately 1,920 swallows every 16 hours during the day and 480 swallows during sleep, or 2,400 swallows per day. This abnormal practice can easily lead to the development of a mouth breathing habit. Mouth breathing is closely linked to brain function, the immune system, and growth changes (not only of the face but also of the body). These patterns contribute to a higher incidence of infections (swollen tonsils and adenoid tissue), further exacerbating the problem.

[0006] Mouth breathing also allows the lower jaw and tongue to move backward at night, resulting in a narrowing of the oropharynx by approximately 6 millimeters (mm) when the mouth is opened 1 / 2 inches during sleep. This provides less oxygen to the baby, which has serious impacts on the brain, immune, and endocrine systems. This explains why a child with sleep-disordered breathing can have neurocognitive, behavioral, and social problems.

[0007] Therefore, there is a need for an oral appliance that encourages a child or adult to solve sleep disorders so as to improve the health of the child or adult.

[0008] The present invention is intended to improve and eliminate some of these known disadvantages in the art. Summary of the present invention

[0009] The habit correction device essentially prevents, corrects or improves the following problems and provides the following benefits.

[0010] Prevents the lower jaw and tongue from shifting backward during sleep, eliminating oropharyngeal obstruction.

[0011] Changes the position of the tongue so that it is located at the palate and is not inside the body of the lower jaw.

[0012] Essentially prevents mouth breathing and forces the patient to breathe through the nose.

[0013] Reduces or corrects thumb sucking.

[0014] Reduces or corrects anterior open bite.

[0015] Advances the lower jaw to achieve correct anteroposterior relationship with the upper jaw.

[0016] Stimulates the growth of the mandibular condyles in retroverted mandibles (small mandibles).

[0017] Reduces or corrects malocclusion.

[0018] Reduces or prevents tongue thrust.

[0019] The device includes a handle that allows you to pull the device forward if needed to strengthen the orbicularis oris muscle (around the lips).

[0020] Wides the rear arch.

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

[0022] According to one embodiment, a habit correction device is provided, comprising a first ramp and a second ramp. The first ramp extends from the front of the device, wherein the first ramp is an upper ramp and is in an upper position near or on the user's palate to direct the tongue toward the palate, which as a result widens the palate and also prevents or reduces mouth breathing, since the position of the lower part of the tongue interferes with daytime mouth breathing. The second ramp extends from the front of the device, wherein the second ramp is a lower ramp located in a position below and under the first frame to substantially prevent the tongue from penetrating into the lower part of the oral cavity. The first ramp ensures an elevated position of the tongue, and the patient learns to swallow with the tongue elevated, which substantially reduces or prevents air from entering the oral cavity through the oral opening.

[0023] According to another embodiment, a habit correction device is provided, comprising an inner wall spaced apart from an outer wall, and one or more lower lingual projections extending from the inner wall. The one or more lingual projections are configured to reduce the tendency of the lower jaw to shift backward during the user's sleep, as well as to increase the movement of the lower jaw and stimulate lower jaw growth.

[0024] According to a further embodiment, a method of using a habit correction device having an upper and lower channel is provided. The method comprises coating the upper and lower channels with a self-curing acrylic or similar material to secure the device in the mouth and substantially prevent mouth breathing from becoming a habit.

[0025] According to an additional embodiment, a method is provided for providing a patient with a habit correction device, wherein the habit correction device has an upper groove with an upper inner barrier and a lower groove with a lower inner barrier. The method includes: adjusting a wire structure located in the upper inner barrier to change the shape of the upper groove, wherein the wire structure includes a curved portion located between ends that are relatively straight; and placing the device with the changed shape into the oral cavity of the patient to expand the patient's dental arch located in the upper groove by moving the anterior extensions toward the upper groove to advance the upper incisors and the upper jaw.

[0026] According to one or more embodiments, slots are located in the lateral portion of both ramps at the rear edges to allow for easier expansion of the upper rear arch.

[0027] According to a further embodiment, a built-in wire (0.030 to 0.045 inches in diameter) is located around the arch from the lingual side from the front to the back of the device.

[0028] The built-in wire can have vertical undulations or bends in the posterior (back) area for better extension of the dentition in the upper or lower arch.

[0029] Three anterior extension wires with a diameter of 0.015-0.028 inches are extended upward from the anterior main wire to move the anterior teeth and maxilla forward. Other numbers of anterior extension wires are suggested. Brief description of the figures

[0030] The above aspects of the present application and the manner in which they are achieved will become more apparent and the ideas of the present application itself will be better understood with reference to the following description of embodiments of the present application, taken together with the accompanying drawings, where:

[0031] Fig. 1 shows a perspective top view of the habit correction device.

[0032] Fig. 2 shows the rear view of the habit correction device.

[0033] Fig. 3 shows the bottom view of the habit correction device.

[0034] Fig. 4 is another rear view of the habit correction device.

[0035] Fig. 5 shows a side sectional view along the longitudinal center line of the habit corrector device.

[0036] Fig. 6 shows a schematic rear view of the habit corrector.

[0037] Fig. 7 shows another embodiment of the habit correction device, rear view.

[0038] Fig. 8 is a perspective view of one embodiment of a wire built into a habit correction device.

[0039] Fig. 9 is a perspective view of another embodiment of a wire embedded in a habit correction device.

[0040] Fig. 10 is a side sectional view along the longitudinal center line of another embodiment of the habit corrector device shown in Fig. 7.

[0041] Fig. 11 shows a flow chart of the process for determining the symptoms, severity, and indices of sleep disordered breathing when determining treatment recommendations.

[0042] Corresponding reference numerals designate corresponding parts in the several views. Although the examples provided herein illustrate embodiments of the present application in several forms, the embodiments disclosed below are not intended to be exhaustive or to be construed as limiting the scope of the present application to the precise forms disclosed. Detailed disclosure of the present invention

[0043] Although illustrative embodiments incorporating the principles of the present invention have been disclosed herein, the present invention is not limited to the disclosed embodiments. However, the present application encompasses any variations, applications, or modifications of the invention using its general principles. Furthermore, the present application encompasses such deviations from the present invention that are within the known or customary practice in the technical field to which the present invention pertains.

[0044] The disclosed habit correction device is applied primarily passively at night to individuals with abnormal sleep problems. The accompanying figures provide an overview of the various design features. The disclosed device is worn primarily passively at night during sleep to encourage the patient or individual to breathe through the nose and reduce or stop mouth breathing at night. The habit correction device addresses abnormal sleep problems in children (and adults), as well as those habits and growth factors known to influence abnormal sleep problems. Figure 1 shows both the upper and lower ramps, where the upper ramp directs the tongue as far as possible toward the palate, while the lower ramp prevents the tongue from assuming a resting position within the body of the mandible.

[0045] Fig. 1 shows a habit corrector device 10, including a high upper outer barrier 12, also called a lip barrier, which essentially prevents air from entering through the patient's oral cavity when opening the oral opening. The habit corrector is available in different sizes to suit different sizes of oral openings and is used on both the upper and lower teeth. The high upper outer barrier 12 extends upward from a groove 14, which is configured to fit the upper teeth, so that the upper teeth are adjacent to the outer barrier 12, the groove 14, and the inner barrier 16. At the rear upper portion 18 in the device 10, the lateral distance D between the outer barrier 12 and the inner barrier 16 is increased to provide a wider groove, in particular in the direction of the lateral sides of the tongue. The upper edge 20 of the outer barrier 12 is located above the upper edge 22 of the inner barrier 16, formed taking into account the surface of the gutter 14.The upper edge 22 of the inner barrier 16, located below the upper edge 20 of the outer barrier 12, projects from the groove 14, providing a high lingual edge for supporting the lateral sides of the tongue in position between the opposite upper edges of the inner barrier. The upper edge 22, at the location of the rear protrusions 23, is located above the upper edge of the wall 32, from which one or more projections 32 extend.

[0046] As used herein, the term "anterior" refers to the portion of the device that is designed to be positioned near the anterior teeth. The device extends from the anterior teeth to the posterior teeth and forms a central longitudinal axis extending from front to back along the midline.

[0047] Fig. 1 further shows the rear portion of the groove 14, which includes an upper rear groove 28 and a lower rear groove 30, as shown in Fig. 3. The upper groove 28 is configured to receive teeth of the upper jaw, and the lower groove 30 is configured to receive teeth of the lower jaw. According to one embodiment, the lower rear groove 30 is coated with a self-curing acrylic resin, which substantially prevents separation of the jaws during sleep, in particular at night. The upper rear groove 28 also includes, according to one or more embodiments, a self-curing acrylic resin located in the groove 14. Other materials are also contemplated in addition to the self-curing acrylic resin, including thermosetting coatings. Additional materials include, but are not limited to, methyl methacrylate, ethyl methacrylate, ethylene vinyl acetate (EVA), or a thermoplastic elastomer (TPE).Using self-curing acrylic resin, the jaws are connected with a closed occlusion (bite) to reduce or prevent the tongue from entering the oropharynx. This double coating of the upper and lower halves (upper and lower gutters) of the appliance prevents the jaws from opening, which would then allow oral breathing. When both the upper and lower halves of the appliance are coated, oral breathing is significantly impeded and becomes habitual. According to one or more embodiments, the resin is relatively hard and is typically not replaced with new resin. If coating is necessary, the user can apply it. Upper gutter 14 and lower gutter 30 are textured to enhance the adhesion of the coating, even in the inner gutter, if necessary.

[0048] One or more projections 32 extend from wall 33 of inner barrier 16 toward the rear of the device to substantially prevent tongue protrusion, reducing the likelihood of tongue protrusion and promoting proper swallowing. According to other embodiments, the riser extends from the side wall of the inner barrier instead of or in addition to projections 32. Projections 32 extend in the lingual portion of the upper arch.

[0049] Fig. 1 also shows high posterior lingual edges formed by the upper edge 22 of the inner barrier 16, which contacts the soft tissues of the tongue of the lateral sides of the hard palate and also ensures penetration of the liner into the interproximal areas (interdental spaces) to enhance retention of the device and to prevent opening of the oral opening. According to another embodiment, shown in Figs. 4 and 5, the likelihood of displacement of the device 10 is reduced, since the device 10 includes an arch wire 34 molded with the device in mind. According to one embodiment, the arch wire 34 is a heavy single-strand wire. According to other embodiments, a plurality of wires are molded with the device in mind.

[0050] The outer barrier 12 includes an upper lip barrier 35 and a lower lip barrier 37 (see Figs. 1, 3, 4 and 6), each of which is located higher toward the front of the device 10 for reducing or preventing breathing through the mouth and for promoting nasal breathing. The lip barrier 35, having a height A shown in Fig. 6, and the lip barrier 37, having a height B shown in Fig. 6, have a height that can be tolerated by patients of different ages, such as 1 to 2 years old, 3 to 5 years old, 6 to 8 years old, 9 to 12 years old, 13 years old and older throughout adulthood. These lip upper and lower barriers must be high enough to be placed in the oral cavity of patients of different ages. This is important because when the patient opens the mouth to allow air to enter the oral cavity and oropharynx, the tongue rests against the anterior wall of the oropharynx, causing it to collapse and reducing the flow of air (oxygen) into the lungs.These barriers also prevent and replace mouth breathing with normal nasal breathing.

[0051] The following Table 1 shows the range of heights A and B for different age groups. However, the illustrated height range is for illustrative purposes only, and heights A and B should not be limited to these specific heights. Different heights, depending on the patient, are adjusted by decreasing or increasing the heights in each age group by approximately 5 mm in either direction.

[0052] The anterior edge 20 of the outer barrier 12, according to various embodiments, is significantly higher than the posterior lingual edges 22 of the inner barrier 16. The posterior buccal edge 21 (part of the upper edge 20) has approximately the same height as the posterior lingual edges 22. These posterior lingual edges 22 are intended for a different purpose than the anterior upper barrier 35 and the anterior lower barrier 37, which are instead intended to prevent breathing through the mouth and sucking the thumb. The posterior edges 21 and 22 are intended to provide coverage in the interproximal spaces of the canines and posterior teeth to prevent displacement of the device 10 and to hold the jaws tightly together to avoid opening the jaws, which could lead to unwanted breathing through the mouth.

[0053] "Covering" is the addition of a separate, harder polymer, such as methyl methacrylate and / or ethyl methacrylate, which are self-curing acrylic materials, to the interdental spaces, most commonly the upper and / or lower back teeth. The goal is to secure the appliance to the teeth and prevent it from falling out of the mouth or to prevent the mouth opening from opening when the upper and lower parts are re-covered with these materials. In some cases (but not often), the dentist may replace the acrylic compound.

[0054] The following Table 2 shows the range of heights of the anterior edge 20 and the posterior lingual edge 22. However, the shown range of heights is illustrative, and therefore the heights should not be limited to the heights indicated in Table 2. For example, the element 22 is 1.4 times higher than the element 20 at the age of 2-4 years, and in adults it is 2.6 times higher. Although these heights are illustrative and generally acceptable for a large number of patients, these distances, according to various embodiments, may differ significantly from the heights indicated in Table 2. The third column of Table 2 shows the ratio of heights for the element 20 compared to the element 22.

[0055] As shown in Fig. 2 and 3, the device 10 includes one or more lower lingual projections 36 that extend from the lower edge of the inner barrier 16. In Fig. 3, the lower lingual projections 36 extend longitudinally toward the back and downward from the front of the groove 14 to promote the forward movement of the lower jaw and prevent the lower jaw from shifting backward during sleep, so as to enhance the effect of treating mouth breathing, protruding the lower jaw and applying pressure to the anterior wall of the oropharynx, which prevents narrowing of the airways, which can lead to a decrease in oxygen supply to the body. The lingual projections 36 are located below the lower ramp or shelf 4 2 and support the oropharynx in an open state.According to one or more embodiments, said projections 36 have a length of 6 to 10 mm, which is approximately 3 to 7 mm longer than the length of projections of currently known habit correctors, in order to provide maximum advancement of the lower jaw, opening of the oropharynx and improved correction of mouth breathing at night.

[0056] The upper posterior lingual projections or processes 32 (see Fig. 4) include small thickenings that remind the child where the tongue is located during swallowing. Other posterior protrusions 23 in Fig. 1 (shown as circles) are intended to indicate the location of the tongue and, therefore, to pull it back, which leads to the expansion of the palate. The protrusions 23 are located on the lingual surface of the lingual palatine projections 22. In one or more embodiments, three (3) of them are typically present, located on the lingual surface of the palatine projections. Another number of protrusions 23 is provided. The processes 32 are also defined by the protrusions of the maxilla, which weaken the thrust of the tongue.

[0057] As shown in Fig. 1 and 3, the device 10 includes a first ramp or shelf 40 and a second ramp or shelf 42, continuing in the direction of the rear part of the device. The first ramp 40 is larger than the second ramp 42 and includes an end edge 44, which extends further to the rear part of the device than the end edge 46 of the second ramp 42. Also shown in Fig. 1, the first ramp 40 is raised relative to the second ramp 42 and, therefore, is closer to the palate than the second ramp 42. The upper, larger and longer first ramp 40 raises the tongue to the palate, and the lower, smaller and shorter second ramp 42 significantly complicates and hinders the positioning of the tongue in the body of the lower jaw. Between the bottom of the first ramp 40 and the top of the second ramp 42 there is a space sufficient to reduce the likelihood of or prevent the tongue from penetrating below or being located below the first ramp 40.According to another embodiment, there may be a connection between the two ramps 40 and 42.

[0058] The positions of the first and second ramps 40 and 42 are also shown in Figs. 2 and 4. The upper ramp 40 is positioned very high, almost inside the palate, so that the tongue learns to rest on the palate, which widens the palate and also prevents mouth breathing, since the lower part of the tongue (the lower section) interferes with mouth breathing both day and night. The lower ramp essentially prevents the tongue from penetrating into the lower part of the oral cavity. The upper ramp 40 promotes an elevated tongue position, and the patient learns to swallow with the tongue elevated. This position also significantly prevents air from entering the oral cavity as a result of mouth breathing.

[0059] Gaps 47 and 48 are located on the sides of both ramps 40 and 42 shown in Fig. 1 to provide unlimited expansion or compression of the rear sections 28 and 30. The built-in wire 15 (see Figs. 4 and 8) having vertically oriented wave structures 49 is located inside the material forming the device 10. The wave structures 49 extend vertically from a relatively straight baseline and include peaks that are typically rounded in shape. The adjustment of the housing along the upper arc is achieved by moving the parts 28 and 30 shown in Figs. 1 and 3 towards or away from each other. As a result of the spacing of the sections 28 and 30 from each other, the expansion of the upper arc increases. According to other embodiments, the wave structure includes peaks that are typically rectangular and periodic, for example a rectangular wave.Other embodiments are envisaged that include a wire that runs longitudinally along the inner barrier 16 and also runs vertically along the inner barrier 16. According to another embodiment, a wire similar to wire 15 is located at the inner barrier located in the lower groove 30.

[0060] An additional wire 50 of a smaller diameter, i.e., 0.020 inches in diameter, is attached to the main built-in wire 15 according to some embodiments, as shown in Fig. 7 and Fig. 9. Other sizes of wires are provided. The wire 50 includes vertical waves 51, which can have, for example, 3 extension wires curved upward for placement inside the palate. The wire 50 and the vertical waves are embedded in plastic projections 53 (see Fig. 7), each of which projects upward from the lingual part of the device when bent forward by hand towards the back of the upper teeth. After moving the projections 53 to the back of the teeth, the upper jaw and incisors move forward over time. In Fig. 7 and 8, the projections of the built-in wire are used in devices that allow the upper jaw and upper incisors to be easily moved forward without any interference from the lip barrier. In fig.10 shows wire 15, including waves 51 of wire 50, located inside the inner barrier 16. In the actual section, wire 15 with waves 49 is not shown. However, in this projection in Fig. 10, oriented wave structures 49 and wire 15 are shown to illustrate the approximate location relative to barrier 16.

[0061] The posterior buccal edge is also enlarged to more securely hold the device in place and prevent jaw opening. The posterior buccal edge of the upper barrier 35 is designated by edge 21, shown in Fig. 1, and in the lower barrier it is designated by edge 37, shown in Fig. 3.

[0062] Fig. 5 is a sectional side view along the longitudinal centerline of the habit correction device. As shown in Fig. 5, the upper ramp or shelf 40 and the lower ramp or shelf 42 are spaced apart from each other to maintain the position of the tongue. The upper, larger and longer first ramp 40 raises the tongue, and the lower, smaller and shorter second ramp 42 significantly prevents and hinders the positioning of the tongue in the lower jaw. The lingual protrusions 36 are located below the lower shelf 42. The shelf 40 directs the tongue upward, towards the palate, and the shelf 42 is shorter and does not allow the tongue to find a resting position in the body of the lower jaw. The tongue is located on the upper part of the shelf 40, which does not allow the patient to breathe through the mouth. For greater comfort of the tongue, the shelf 40 can be slightly curved downward in the middle part.The lingual projections 36 extend downwards, are longer and more effective, which prevents the lower jaw from shifting backwards during sleep, and also keeps the lower jaw away from the oropharynx, which prevents its collapse.

[0063] Additional embodiments are described below. While the embodiments generally describe a method for producing devices, a final device having the described features is also provided.

[0064] As described herein, one embodiment of a habit correction device includes forming a first trough and a second trough, each of which is lined with a material to reduce the likelihood of jaw opening, thereby reducing or preventing mouth breathing.

[0065] According to another embodiment, a method is provided for providing a correction device comprising a wire that has an embedded wire wave-like structure, such as vertical curves, wherein the wire wave-like structure is formed in the lingual portion of the habit correction device. The wire structure extends from one side of the device, for example, near the rear left side, to the other side of the device, for example, near the rear right side.

[0066] According to an additional embodiment, a method is provided for providing a correction device comprising a wire that includes an embedded wave-shaped wire structure, wherein the embedded wire structure is flexible, and the wire maintains its shape after being bent to a desired location. The flexible wire allows the user to change the shape of the device to increase or decrease the distance between the sides to change the width of the upper arch.

[0067] According to a similar embodiment or other embodiments, a habit correction device is provided, comprising a bendable wire that allows the user to change the shape of the device to increase or decrease the distance between the sides, built into the lower arch of the device for changing the width of the lower arch.

[0068] According to another embodiment, a method is provided for preparing a habit correction device with an upper shelf, a lower shelf, or both an upper and lower shelf. The shelves are not directly connected to the sides of the device, but are separated from the sides to facilitate increasing or decreasing the transverse distance between the sides. Once the distance is set by the user, the embedded wire maintains its shape in the new selected position until further manipulation of the wire.

[0069] According to an additional embodiment of the habit correction device, the method includes preparing a habit correction device, wherein the upper and lower walls of the front part of the device are exceptionally high to prevent breathing through the mouth, even when the mouth opening is open, and to stimulate breathing through the nose. For example, in one or more embodiments, an increase of approximately 25% of the values ​​​​shown in Table 2 above is considered "exceptionally high". An illustration of such dimensions is shown in the following Table 3, where each dimension is indicated in millimeters. The columns in Table 3 are labeled A and B. Fig. 6 describes the recommended values ​​​​of the height 20 of Fig. 1 and 41 of Fig. 2, as well as what an increase of 25% will be in the columns labeled A (+ 25%). and B (+ 25%). The heights A and B 20 and 41 are indicated in the following Table 3.

[0070] According to another embodiment, a method for embedding a flexible wire appliance is provided, wherein the appliances are habit correction appliances, Max A appliances, and Class III appliances. The Max A appliance is a device that advances the upper incisors and the upper jaw to an anterior position (forward) relative to the lower jaw. This is achieved by three elongated projections attached to the upper anterior lingual barrier. Pressure of the tongue on these projections pushes the upper arch (teeth and bone) forward, since the Max A (or Class III appliance) lacks a labial barrier.

[0071] The Class III appliance has the same upper section as the Max A, but has a bumper on the lower anterior portion of the lower barrier, which exerts posterior pressure on the lower row of teeth. The Max A corrects midface retrusion, while the Class III appliance corrects mandibular protrusion (forward protrusion of the lower jaw) in conjunction with the treatment of maxillary retrusion.

[0072] Other embodiments include a method for manufacturing a fixture with an integrated wire, which includes additional wires attached to the main wire of varying configurations, which are intended for other purposes, such as advancing the maxilla and upper teeth. The additional wire attached to the main wire is thinner, of the same size, or thicker than the main wire, in some embodiments. According to other embodiments, a single main wire of varying thickness or diameter includes features of the additional wire.

[0073] According to an additional embodiment, there is a method for manufacturing a device that includes an embedded wire with bends in the rear portion of the main wire with additional wires of smaller diameter having several raised extensions for applying pressure to the upper jaw and the upper anterior teeth in order to advance the upper jaw and the upper anterior teeth by pushing these wire extensions forward when embedded in the device.

[0074] To determine or diagnose sleep-disordered breathing, one or more sleep questionnaires are used, depending on the patient's age. The most commonly used sleep questionnaire is designed for patients aged 5-7 years, but it can also be used for patients aged 8-12 years. Each questionnaire presents a list of symptoms in the form of questions. The answers to the questions are used to determine whether a habit modification device is recommended for the patient. According to one embodiment, the determination is conducted initially, or for the first time, before the patient begins using the habit modification device, and then again later, or a second time, after a period of use, for example, 6 months, to determine the effectiveness of the device. Further, at a later time, to determine the sustainability of improvement or a relapse, which may occur after several months or years.

[0075] Fig. 11 shows one embodiment of an example flow chart 58 for determining or diagnosing sleep disordered breathing, which is used either alone or in combination with sleep questionnaires. If a sleep questionnaire is not used, a decision can be made by a practicing physician. When using a questionnaire, initially, in block 60, the patient completes a sleep and speech questionnaire, which includes a series of questions requiring answers, which, when answered, provide treatment recommendations. These questions cover one or more of the following symptoms: snoring; sigmatism; shortness of breath; omitted consonants; intermittent snoring; nasal speech or hoarseness of voice; hyperactivity; wetting the bed; mouth breathing; frequent interruptions; headaches in the morning (before noon); frequent infections; allergies; grinding teeth; excessive sweating; restless sleep; talking or walking in sleep; attention deficit; poor performance in school and waking up at night.Although each of these symptoms is included in one or more age-related questionnaires, other symptoms may be included as needed. In one or more embodiments, each symptom is also characterized by a severity rating. For example, in various embodiments, severity is rated on a scale of 0 to 5. Other rating scales are also possible. A severity rating of 0 indicates no symptoms, 1-2 (approximately 1-2 times per week) indicates mild severity, 3 indicates moderate severity (occurring approximately 3-4 times per week), and 4-5 indicates severe severity (almost always present 5-7 nights per week).

[0076] After completing the questionnaire, it is reviewed to determine the number of symptoms, their severity, and an index. The index is a value determined by adding the number of symptoms and the cumulative overall severity. The cumulative overall severity is determined by adding the severity value determined for each of the symptoms. See block 60. After determining the index, various treatment recommendations are made based on the questionnaire results. According to 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 additional grades are contemplated. As can be seen from each block, treatment is recommended depending on the severity of the disease. Each of the blocks also indicates the symptom values, severity, and index needed to provide the recommended treatment and the need for treatment.

[0077] For example, as shown in Block 62 with a grade of 1, no treatment is required or there is little need for treatment according to Block 72. In addition, for single symptoms of a certain type, such as types 4, 5, 6, 9, 10, 25 and ADHD (Attention Deficit Hyperactivity Disorder), treatment according to Block 74 is recommended. See the following Table 4.

[0078] Each of the blocks 64, 66, 68 and 70 includes a recommended treatment and a need for treatment, as shown in the 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, but the need for treatment in each of the blocks is different: from a slight need according to block 76 to a pronounced need according to block 80. For degree 5, according to block 70, mandatory treatment is recommended, and the need is considered significant. After the treatment is recommended, the recommended type of treatment is assigned to the patient by a practicing physician or artificial intelligence via a computer directly to the patient. According to various embodiments, the treatment includes a number of treatment sessions per day, as well as the time during which the device is in place for each treatment session.Treatment may include a suggested treatment that is strictly followed, a suggested treatment that is adjusted by a practitioner or computer, or treatment prescribed by a practitioner or computer based on the results of a completed patient survey.

[0079] Although illustrative embodiments incorporating the principles of the present invention have been described herein, the present invention is not limited to such embodiments. However, the present application encompasses any variations, applications, or adaptations of the invention using its general principles. Furthermore, the present application encompasses such deviations from the present invention that are within the known or customary practice in the technical field to which the present invention pertains.

Claims

1. A device for promoting nasal breathing and reducing mouth breathing during sleep, comprising: a first ramp extending from the front of the device that is an upper ramp located near the user's palate and configured to direct the tongue toward the palate; and a second ramp extending from the front of the device, which is a lower ramp located below and under the first ramp, wherein the second ramp is configured to block the passage of the tongue into the lower part of the oral cavity space, and the first ramp is configured to maintain the raised position of the tongue during swallowing; an upper trough with an upper inner barrier and a lower trough with a lower inner barrier, a wire structure is built into the upper inner barrier, including vertically oriented wavy structures extending from a straight base line, the wire structure is flexible and is designed with the ability to retain its shape after bending; and a smaller diameter wire, fitted with anterior extensions that curve forward towards the back of the upper teeth, attached to the wire structure and embedded in upwardly protruding plastic tabs.

2. The device according to claim 1, characterized in that the front part of the device includes an outer barrier and an inner barrier located at a distance from the outer barrier, wherein the first ramp and the second ramp extend from the inner barrier.

3. The device according to claim 2, characterized in that the outer barrier forms a first groove with an inner barrier, wherein the first groove is designed to receive the user's upper jaw teeth, and forms a second groove with an inner barrier, wherein the second groove is designed to receive the user's lower jaw teeth.

4. The device according to paragraph 3, characterized in that the first chute and the second chute are covered with a material to reduce the likelihood of opening the jaws.

5. The device according to paragraph 4, characterized in that the first trough and the second trough are covered with a polymer material.

6. The device according to claim 5, characterized in that at least one of the first trough, the second trough and the barriers is textured with surface texture elements designed to mechanically interact with the covering material.

7. The device according to claim 5, characterized in that the inner barrier includes a wall extending upward from the first groove, wherein the wall includes a first side facing the first groove and a second side facing the space of the device adapted to receive the tongue, wherein one or more rear protrusions are located on the second side of the wall of the inner barrier.

8. The device of claim 7, characterized in that it contains one or more lingual projections, wherein the lingual projections extend from the front to the back of the device and are designed to resist backward displacement of the lower jaw during sleep.

9. The device according to claim 3, characterized in that it contains one or more gaps located between the lateral boundaries of one or both of the first ramp and the second ramp for expanding one or both of the first trough and the second trough.

10. A device for promoting nasal breathing and reducing mouth breathing during sleep, comprising: an internal wall located at a distance from the external wall; and one or more lower lingual projections extending from the inner wall and configured to resist backward displacement of the lower jaw during sleep, wherein the lower lingual projections extend longitudinally in the direction backwards and downwards from the inner wall, the inner wall is located at a distance from the outer wall to form at least a first groove configured to receive teeth of the upper jaw and a second groove configured to receive teeth of the lower jaw; an upper trough with an upper inner barrier and a lower trough with a lower inner barrier, a wire structure is built into the upper inner barrier, including vertically oriented wavy structures extending from a straight base line, the wire structure is flexible and is designed with the ability to retain its shape after bending; and a smaller diameter wire, fitted with anterior extensions that curve forward towards the back of the upper teeth, attached to the wire structure and embedded in upwardly protruding plastic tabs.

11. The device according to claim 10, characterized in that the lower tongue projections extend longitudinally towards the rear of the device and downwards from the inner wall.

12. The device according to claim 11, characterized in that the outer wall forms with the inner wall a first groove, designed to receive the teeth of the user's upper jaw, and forms a second groove with the inner wall, wherein the second groove is designed to receive the teeth of the user's lower jaw.

13. The device according to claim 12, characterized in that it comprises a first ramp extending from the inner wall, wherein the first ramp is an upper ramp located near the user's palate, and a second ramp extending from the inner wall, wherein the second ramp is a lower ramp located lower than the first ramp.

14. The device according to item 13, characterized in that the lower tongue projections are located below the lower ramp.

15. The device according to claim 14, characterized in that the inner wall includes a first side facing the first groove and a second side facing the space adapted to receive the tongue, wherein one or more rear protrusions are located on the inner wall on the second side.

16. The device according to claim 15, characterized in that the inner wall includes a front part and a rear part, wherein one or more rear bulges are located in the rear part of the inner wall.

17. The device according to claim 16, characterized in that the rear part of the inner wall is higher than the front part of the inner wall.

18. The device of claim 17, characterized in that it comprises one or more upper lingual projections extending from the front portion of the inner wall, wherein the one or more upper lingual projections include thickenings located on the surface facing the tongue.

19. The device according to claim 18, characterized in that the first ramp has a first length, and the second ramp has a second length, wherein the first length is greater than the second length, and the end edge of the first ramp extends further toward the rear of the device than the end edge of the second ramp.

20. The device according to claim 19, characterized in that the first ramp is designed to support the tongue in a raised position, and the second ramp is designed to block the passage of the tongue into the lower part of the user’s oral cavity.

21. A method for providing a patient with a device for promoting nasal breathing and reducing mouth breathing during sleep, which device has an upper chute with an upper internal barrier and a lower chute with a lower internal barrier, comprising: adjusting a wire structure located in the upper inner barrier to change the shape of the upper gutter, wherein the wire structure is built into the upper inner barrier, includes vertically oriented wavy structures extending from a straight baseline, is flexible and is designed to retain its shape after bending; and placing a device with a modified shape in the oral cavity of a patient for expanding the dental arch of the patient, located in the upper groove, by moving the anterior extensions towards the upper groove to advance the upper incisors and the upper jaw, wherein the anterior extensions are moved towards the lips in order to move the upper incisors and the upper jaw forward relative to their position before treatment, wherein a wire of a smaller diameter is provided with anterior extensions that are curved forward towards the back of the upper teeth, is attached to the wire structure and is built into upwardly protruding plastic projections.

22. The method according to claim 21, characterized in that it includes coating the upper groove and the lower groove with a self-hardening acrylic material for fixing the device in the oral cavity.

23. The method according to claim 22, characterized in that it includes adjusting the wire to lengthen the wire structure located in the projections protruding from the part of the device for moving the upper teeth in the forward direction.

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