Dental appliance for treating sleep disorders

Abstract

Methods of making a dental appliance for use in the treatment of patients suffering from obstructive sleep apnea or hypopnea are disclosed. The invention further discloses the dental appliance and application thereof.

Description

[0001] This application is a divisional application of an application with a filing date of February 15, 2022, an invention name of “Dental appliance for treating sleep disorders”, an international application number of PCT / US2022 / 016440 and a Chinese national application number of 202280028458.0.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority based on U.S. Provisional Application No. 63 / 158,139 filed on March 8, 2021, the entire contents and disclosure of which are incorporated herein by reference in their entirety. Background Art

[0004] Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by recurrent episodes of reduced (hypopnea) or cessation (apnea) of airflow during sleep due to upper airway collapse caused by pharyngeal narrowing.

[0005] In obstructive sleep apnea patients, breathing stops repeatedly during sleep because the throat muscles intermittently relax to the point of completely blocking the airway. In hypopnea patients, the airway is significantly reduced but not completely blocked.

[0006] OSAHS affects 9-38% of adults and increases with age and obesity. See Liu et al., Sci.Rep.10, 3394 (2020). According to the National Healthy Sleep Awareness Project, at least 25 million adults in the United States suffer from OSAHS. See AASM Press Releases, September 29, 2014. OSAHS symptoms include excessive snoring, daytime sleepiness, chronic fatigue, morning headaches, depression, irritability, and high blood pressure. If untreated, OSAHS reduces quality of life and may also lead to more serious conditions, such as increased depression, type II diabetes, stroke, and even the risk of sudden death in patients with heart disease due to repeated drops in blood oxygen levels.

[0007] Nasal continuous positive airway pressure (CPAP) is the most common treatment modality, in which OSAHS patients wear a mask connected to a machine that delivers positive pressure during sleep and forces the airway open. Many patients refuse CPAP for reasons including nasal dryness, mask irritation, arousal, machine noise, claustrophobia, and bloating. Therefore, CPAP is not well accepted in OSAHS patients.

[0008] Dental appliances have been used as an alternative to CPAP therapy. See Pételle et al., American Journal of Respiratory and Critical Care Medicine 165, 1150-53 (2002); Dort et al., European Respiratory Journal 27, 1003-09 (2006). When worn by patients during sleep, they are intended to keep the airway open directly by moving the laryngeal muscles forward, or indirectly by advancing the mandible. Compared with CPAP, dental appliances are less invasive and therefore more acceptable to patients. However, their efficacy is not high, as low as 45% of CPAP. See Basyuni et al., J.Thorac Dis 2018, 10 (Suppl. 1), S48-56. Recent improvements centered on design features are still unsatisfactory. See U.S. Patent Application Publication Nos. 2013 / 0112210 and 2015 / 0272772.

[0009] There is a need to develop an effective dental appliance for treating OSAHS. Summary of the invention

[0010] The present application provides methods of making dental appliances that are surprisingly effective in treating patients suffering from OSAHS.

[0011] Therefore, one aspect of the present invention relates to a first method of preparing a dental appliance for treating a patient suffering from obstructive sleep apnea or hypopnea. The method comprises the following steps:

[0012] (i) identifying a patient having mandibular dentition, maxillary dentition, a tongue, an airway, and an epiglottis, wherein the mandibular dentition has a central incisor and a mandibular center point located at the apex of the central incisor,

[0013] (ii) optionally sedating the patient to sleep,

[0014] (iii) locating the reference position (0, 0) of the mandibular center point when the maxillary dentition and the mandibular dentition are fitted together with maximum interdental interdigitation,

[0015] (iv) determining the target position (X) of the mandibular center point tp , Y tp ), the mandibular dentition is moved to the target position so that the patient's airway and epiglottis are opened,

[0016] (v) constructing a dental appliance having a lower arc segment, an upper arc segment, and a connecting segment connecting the lower arc segment and the upper arc segment,

[0017] in

[0018] The lower arc segment is conformal to the mandibular dentition,

[0019] The upper arc segment is conformal to the maxillary dentition,

[0020] X tp is the target position (X tp , Y tp ) and the reference position (0, 0),

[0021] Y tp is the target position (X tp , Y tp ) and the reference position (0, 0), and

[0022] The lower arc segment is located at the same position as the target position (X tp , Y tp ) corresponding to the position.

[0023] Generally, X tp and Y tp Measurements are made in millimeters (mm).

[0024] The first method above optionally further comprises the following four steps:

[0025] (vi) determining the maximum protrusion position (X) of the mandibular center point max ), said mandibular dentition is maximally protruded to said maximum protrusive position to its maximum extent,

[0026] (vii) determining the maximum mouth opening position (Y) of the mandibular center point max ), the mandibular dentition is vertically opened to the maximum opening position to its maximum extent,

[0027] (viii) using the target position (X tp , Y tp) and the reference position (0, 0) to calculate the formula y = ax, where a is Y tp / X tp ,as well as

[0028] (ix) determining the adjusted position of the mandibular center point (X adj , Y adj ),

[0029] in

[0030] X max is the reference position (0, 0) and the maximum forward position (X max ),

[0031] Y max is the reference position (0, 0) and the maximum opening position (Y max ),

[0032] X adj / X max 1% to 80%, preferably 2% to 75%, and more preferably 3% to 75%, Y adj / Y max 1% to 70%, preferably 1% to 65%, and more preferably 2% to 60%,

[0033] Y adj =aX adj ,and

[0034] The lower arc segment moves to the adjustment position (X adj , Y adj ).

[0035] The value of a is passed through Y tp / X tp For most patients, the value of a is in the range of 0.2 to 15.

[0036] The first method may further include the following steps:

[0037] (x) obtaining a digital data set by scanning the mandibular dentition and the maxillary dentition,

[0038] (xi) registering the digital data set into a computer system,

[0039] Wherein the dental appliance is constructed using the digital data set.

[0040] Endoscopy is most commonly used to determine whether the airway and epiglottis are open while the patient is asleep, preferably under sedation.

[0041] Another aspect of the present invention relates to a second method for preparing a dental appliance for treating a patient suffering from OSAHS. The second method comprises the following steps:

[0042] (a) identifying a patient having maxillary dentition, mandibular dentition, a tongue, an airway, and an epiglottis, wherein the mandibular dentition has a central incisor and a mandibular center point located at the apex of the central incisor,

[0043] (b) locating the reference position (0, 0) of the mandibular center point when the maxillary dentition and the mandibular dentition are fitted together with maximum interdental interdigitation,

[0044] (c) Determine the maximum protrusion position (X) of the mandibular center point max ), said mandibular dentition is maximally protruded to said maximum protrusive position to its maximum extent,

[0045] (d) Determine the maximum mouth opening position (Y) of the mandibular center point max ), the mandibular dentition is vertically opened to the maximum opening position to its maximum extent,

[0046] (e) Determine the target position (X) of the mandibular center point tp , Y tp ), where Y tp =bX tp , Y tp =mY max , and X tp =nX max , b is 1 to 10 (preferably 1.2 to 8, and more preferably 1.5 to 6.5), m is 5% to 70% (preferably 8% to 60%, and more preferably 12% to 50%), and n is 5% to 80% (preferably 12% to 70%, and more preferably 20% to 60%), and

[0047] (f) constructing a dental appliance, the dental appliance having a lower arc segment, an upper arc segment, and a connecting segment connecting the lower arc segment and the upper arc segment,

[0048] in

[0049] The lower arc segment is conformal to the mandibular dentition,

[0050] The upper arc segment is conformal to the maxillary dentition,

[0051] X max is the reference position (0, 0) and the maximum forward position (X max ),

[0052] Y maxis the reference position (0, 0) and the maximum opening position (Y max ),

[0053] X tp is the target position (X tp , Y tp ) and the reference position (0, 0),

[0054] Y tp is the target position (X tp , Y tp ) and the reference position (0, 0), and

[0055] The lower arc segment is located at the same position as the target position (X tp , Y tp ) corresponding to the position.

[0056] The second method optionally includes the following steps: (g) determining the adjusted position (X) of the mandibular center position adj , Y adj ), where X adj / X max is 5% to 80% (preferably 6% to 75%, and more preferably 7% and 70%), Y adj / Y max 5% to 70% (preferably 6% to 60%, and more preferably 7% to 50%), and the lower arc segment moves to the adjustment position (X adj , Y adj ).

[0057] Additionally, the second method may include the steps of: (h) obtaining a digital dataset by scanning the mandibular dentition and the maxillary dentition, and (i) registering the digital dataset into a computer system, wherein the dental appliance is constructed using the digital dataset.

[0058] Dental appliances prepared by any of the above methods are also within the scope of the present invention.

[0059] Referring to the dental appliances, each of them has a lower arc segment and an upper arc segment, each of which has two rear segments and one front segment. Each dental appliance has an opening at their front segment between the lower arc segment and the upper arc segment, and the opening has a width of 20% to 50% relative to the maximum width of the tongue.

[0060] Materials suitable for making the dental appliance of the present invention include durable orthodontic materials known in the art, such as acrylic polymers or copolymers, acrylate polymers or copolymers, polypropylene-derived materials, polyvinyl chloride-derived materials, polyurethane-derived materials, and any combination thereof.

[0061] The details of one or more embodiments of the invention are set forth in the following description and the accompanying drawings. Other features, objects, and advantages of the invention will be apparent from the description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1A The cusp-matching position (ICP) with reference position A (0, 0) is shown, where the mandibular dentition fits together with the maxillary dentition in maximum interdental interdigitation. The mandibular dentition can move from reference position A to a position (X, Y) with two components, namely horizontal movement (X) and vertical movement (Y).

[0063] Figure 1B Shows the maximum forward position B(X max , Y 1 ), in which the mandibular dentition moves forward to its maximum extent, reaching a maximum horizontal movement of X max and short vertical movement Y 1 .

[0064] Figure 1C The maximum mouth opening position C(X 2 , Y max ), where the mandibular dentition opens vertically to its maximum extent, reaching the maximum vertical movement Y max and short horizontal movement X 2 .

[0065] Figure 1D The reference position A(0,0), the maximum forward position B(X max , Y 1 ) and the maximum opening position C(X 2 , Y max ) form a triangle, representing the maximum area that the mandibular center point can travel.

[0066] Figure 2A is a photograph of a partially opened epiglottis and airway.

[0067] Figure 2B This is a photo of the fully opened epiglottis and airway.

[0068] Figure 2C The airway open position is shown.

[0069] Figure 2D The closed position is shown.

[0070] Figure 3 The target position (point TP) and the adjusted position (point adj) of the mandibular center point are shown.

[0071] Figure 4A is a photograph of the dental appliance of the present invention viewed from its side.

[0072] Figure 4B is a photograph of the dental appliance of the present invention as viewed from the front.

[0073] Figure 4C Dental appliances attached to the mandibular and maxillary dentition are shown in model. DETAILED DESCRIPTION

[0074] The patient wears the dental appliance of the present invention to treat OSAHS. It helps keep the patient's airway and epiglottis open during sleep. This is achieved by forcing the mandibular dentition to a target position that opens the airway and provides comfort at the same time. In the target position, the patient's mandible is advanced in a process commonly referred to as mandibular advancement, which moves the tongue forward, preventing the tongue from blocking the entrance to the trachea. Mandibular advancement also opens the airway by moving the laryngeal muscles.

[0075] Mandibular advancement is best measured by movement of the mandibular dentition with two central incisors. Either can be used to set the measurement point, which is defined as the mandibular center point at the tips of the central incisors. The right central incisor is usually chosen to define the mandibular center point. All movements of the mandibular dentition are measured using the mandibular center point.

[0076] In this application, the movement of mandibular advancement is quantified starting from the cusp occlusal position (ICP), which is the position of the mandibular dentition when the mandibular dentition fits together with the maxillary dentition in maximum interdental interdigitation. ICP is also called habitual bite, habitual position, or bite of convenience, which is named after the position that the patient is accustomed to when asked to bite together. The center point of the mandible in the ICP state is designated as the reference position A(0,0), which has zero horizontal and vertical movement. See Figure 1A .

[0077] The mandibular center point moves forward from the ICP to a position (X, Y) with two components, namely horizontal movement (X) and vertical movement (Y). Usually measured in millimeters (mm), X and Y are the horizontal and vertical distances, respectively, that the mandibular center point travels from the ICP during mandibular advancement. Unlike the mandibular dentition, the maxillary dentition does not move during mandibular advancement.

[0078] When the mandibular dentition moves forward to its maximum extent, it reaches the maximum horizontal movement X max and short vertical movement Y 1 The maximum forward position B. Figure 1B On the other hand, when the mandibular dentition is vertically opened to its maximum extent, it reaches the maximum vertical movement Y max and short horizontal movement X 2 The maximum mouth opening position C. Figure 1C . Reference position A(0,0), maximum forward position B(X max , Y 1 ) and the maximum opening position C(X 2 , Y max ) form a triangle ABC, which represents the maximum area that the center point of the mandible can travel. Figure 1D .

[0079] Unexpectedly, when the mandibular center moves to the target position TP (X tp , Y tp ), the airway opens to its maximum extent and the epiglottis also opens to its maximum extent, thereby eliminating or reducing sleep interruptions caused by OSAHS.

[0080] X tp and Y tp Patient dependent. They must be determined for each individual patient. X tp Generally, it is in the range of 0.2 mm to 10 mm (e.g., 0.3-8 mm and 0.4-6 mm). tp Typically in the range of 0.5 mm to 50 mm (eg, 0.8-40 mm and 1-30 mm).

[0081] X x Can be in the range of 2 mm to 25 mm (e.g., 3-20 mm and 3.5-15 mm). max It may be in the range of 8 mm to 80 mm (eg, 10-70 mm and 12-60 mm).

[0082] For example, the target position is determined by two methods. In the first method, the target position is accurately located by endoscopy or serial computed tomography (CT) of a patient with OSAHS. Before or after the endoscopy or CT procedure, the patient's dentition is scanned to obtain information for constructing a dental appliance. The mandibular center point and reference position are also identified and recorded.

[0083] Scanning can be performed using X-rays, computer-aided topography (CAT scan), magnetic resonance imaging (MRI), and any other method known in the art. A three-dimensional digital data set representing the mandibular dentition, the maxillary dentition, and their relative positions can be readily obtained. The scan data set can also be obtained by conventional techniques (e.g., preparing a plaster model followed by laser scanning).

[0084] The scan data sets are typically registered to a computer system and can be used to visualize the dentition, simulate their movement in a computer program, design and improve dental appliances that fit over the dentition, and construct dental appliances in a three-dimensional (3-D) printer.

[0085] The scan data set is used in combination with information about the target position. Endoscopy and CT are two convenient techniques for identifying the target position of the mandibular center point while the patient is asleep, sedated, anesthetized, or unconscious. The patient's mandibular dentition is protruded or moved vertically while the epiglottis and airway are monitored by endoscopy or CT. The target position is reached when the airway and epiglottis are opened to the maximum extent. This position is defined as (X tp , Y tp ), where X tp is the horizontal distance traveled by the mandibular center point, and Y tp is the vertical distance traveled by the mandibular center point, both starting from the ICP.

[0086] The target position is usually determined to the satisfaction of a trained specialist (chest physician or pulmonologist). Figure 2 shows (A) a partially open epiglottis and airway, (B) a fully open epiglottis and airway, (C) an open airway position, and (D) a closed position. In determining the maximum airway opening, a photograph may be taken to show a front view of the airway, the area of ​​the airway in the photograph is then measured, and the opening corresponding to the largest area is determined as the maximum airway opening.

[0087] During endoscopic or CT procedures, supplemental scan data sets can be obtained and used to simulate mandibular advancement, muscle movement, airway opening, and epiglottis position when improvements to dental appliances are desired.

[0088] The standard dental appliance (i.e., the preferred embodiment of the present invention) uses a target position (X tp , Y tp ) together with the scanned data set.

[0089] Some patients prefer modified dental appliances over standard dental appliances due to comfort or other reasons.

[0090] In addition to using the Adjust Position (X adj , Yadj ) instead of the target position (X tp , Y tp ), the improved dental appliance is constructed in the same manner as a standard dental appliance.

[0091] Adjust position (X adj , Y adj ) falls on a point that passes through both the reference position (0, 0) and the target position (X tp , Y tp ) is on the line y = ax. Figure 3 In this equation, a is calculated as Y tp / X tp In the adjusted position, the airway is open by at least 20% (eg, at least 30%, at least 40%, and at least 50%) compared to a maximum airway opening.

[0092] Preferably, X adj In the range of 0.2 mm to 8 mm (e.g., 0.3-6 mm and 0.4-5 mm), and Y adj In the range of 0.5 mm to 20 mm (eg, 0.8-15 mm and 1-10 mm).

[0093] Then use the Adjust Position (X adj , Y adj ) and scan data to prepare improved dental appliances.

[0094] A series of improved dental appliances can be prepared according to the above method. Then patients wear them and standard dental appliances one at a time to evaluate comfort and clinical efficacy using protocols well known in the art. Based on the evaluation of clinical data and wearing experience, the most suitable dental appliance is selected for daily use.

[0095] As another example, the dental appliance of the present invention is prepared as follows: (i) scanning the patient's oral cavity with the assistance of a computer system to establish a dental model including at least the mandibular dentition and the maxillary dentition, (ii) repeatedly scanning the patient's oral cavity to identify a target position while moving the patient's mandibular dentition until the epiglottis and the airway are opened to their maximum limits, (iii) recording the target position in the computer system, and (iv) preparing the dental appliance based on the dental model and the target position of the mandibular dentition.

[0096] The target position thus identified requires less forward displacement than conventional dental appliances and is therefore more comfortable for the patient to wear.

[0097] In addition, the dental appliance can be prepared by the method 2 of the present invention, especially when the patient is unable to undergo a study to determine the target position. Thus, the second method of determining the target position involves calculating the target position (X) using the following three equations: tp , Y tp ):

[0098] (i)Y tp =bX tp , b is 1 to 10, preferably 1.2 to 8, and more preferably 1.5 to 6.5,

[0099] (ii) Y tp =mY max , m is 5% to 70%, preferably 8% to 60%, and more preferably 12% to 50%, and

[0100] (iii)X tp =nX max , n is 5% to 80%, preferably 12% to 70%, and more preferably 20% to 60%.

[0101] Surprisingly, it was found that when the patient's mandibular center point rests at this target position, the airway and epiglottis open during sleep, thereby effectively treating OSAHS. tp , Y tp ) and constructed from scan datasets collected from the mandibular and maxillary dentition.

[0102] In the second method, the dental appliance can also be adjusted according to the above procedure, as long as X adj and Y adj The above three equations are sufficient.

[0103] X tp , Y tp , X adj , Y adj , X max and Y max It can have the range as described above.

[0104] The dental appliance of the present invention can be manufactured according to any known method, such as three-dimensional (3-D) printing, thermoforming, direct manufacturing, machining, or any combination thereof. Stereolithography (SLA) is an exemplary 3-D printing technology that utilizes a layer-by-layer approach of a photochemical process, by which light causes monomers and oligomers to cross-link with each other to form polymers. Digital light processing (DLP) is another example, in which a digital projector is used as a light source for cross-linking monomers or oligomers. Material jetting (MJ) 3-D printers are also suitable, which dispense liquid monomers, oligomers, or resins from a print head onto a build tray and immediately cure them under ultraviolet light.

[0105] Available 3-D printers include: Those sold by 3D Systems (Rock Hill, SC) under the trade name 5100, and those sold by SprintRay (Los Angeles, CA) under the trade name Pro95.

[0106] Suitable materials include: (Netherlands) under the trade name Ortho The acrylate of Detax GmbH & Co. (Ettlingen, Germany) is available under the trade name Splint's acrylic / methacrylic resins and Dreve Dentamid GmbH (Unna, Germany)'s trade names Guide 405nm methacrylate resin.

[0107] The target position or adjustment position information and the digital scan data are registered in the 3-D printer. Optionally, a computer-aided design tool and a 3-D printing program are used to design and adjust the dental appliance of the present invention. The 3-D material is dispersed from the print head for manufacturing the dental appliance according to a preset program. After or during printing, the material is hardened, usually by UV curing, to ensure complete cross-linking.

[0108] Alternatively, the dental appliance of the present invention can be manufactured from a block of material by machining using computer numerical control (CNC) machining. Other materials that can be used to construct the dental appliance of the present invention include: polypropylene derived materials, polyvinyl chloride derived materials, and polyurethane derived materials, as well as any material that can be safely used to construct a dental appliance.

[0109] The dental orthodontic appliances thus prepared each have a lower arc segment, an upper arc segment, a connecting segment connecting the lower arc segment and the upper arc segment, and optionally an opening formed between the lower arc segment, the upper arc segment and the connecting segment. When worn by a patient, the lower arc segment conforms to the patient's mandibular dentition, and the upper arc segment conforms to the maxillary dentition. The lower arc segment and the upper arc segment each have: (i) two rear segments corresponding to the molars and premolars in the dentition, and (ii) one front segment corresponding to the canine and incisor. For an example of the dental orthodontic appliance of the present invention, see Figure 4A , 4B and 4C. Figure 4A is a side view of an exemplary dental appliance. Figure 4B This is the front view. Figure 4C A dental appliance is shown attached to the mandibular and maxillary dentition.

[0110] like Figures 4A-4C As shown, the lower arc segment and the upper arc segment are symmetrical along the median plane passing through the center of the dental appliance. The upper arc segment is located above the lower arc segment and is coupled to the maxillary dentition. The lower arc segment is coupled to the mandibular dentition. The upper and lower arc segments are connected at their rear sections, but separated at their front sections to leave an opening that allows air to pass and the tongue to move forward, thereby further opening the airway at the back of the mouth.

[0111] Refer again Figures 4A-4C , the lower arc segment and the upper arc segment each have an outer side, a medial side and an occlusal surface. The medial side runs along the lingual surface of the dentition and is the contact point between the orthodontic appliance and the inner surface of the maxillary and mandibular teeth including the dentition and gums. It encounters the lingual surface at the anterior teeth, posterior teeth and gums, wherein the anterior teeth include the central incisors, lateral incisors and canines, and the posterior teeth include the first and second premolars and the first, second and third molars. The outer side surfaces of the upper and lower arc segments run along the buccal surface of the dentition and contact the buccal surfaces of the teeth and gums. The occlusal surface contacts the chewing surface or incisor surface of the teeth.

[0112] The outer side surface and the inner side surface are coupled at their rear sections through an occlusal surface to form a support structure for fixing the dental appliance to the teeth.

[0113] An opening is formed from the upper right canine tip to the left canine tip. The width of the opening is about 20% to 50% (preferably 33%) of the maximum width of the tongue.

[0114] When worn by a patient, the dental appliance of the present invention moves the mandibular dentition horizontally by 0.7 mm to 6 mm and vertically by 1 mm to 15 mm. This small horizontal forward movement provides maximum comfort to the patient and ensures compliance with treatment. The opening contributes to further comfort by moving the tongue forward. In addition, the small vertical distance enables the patient to close his lips, which is another feature that contributes to comfort.

[0115] Even if an adjustable design is possible with a connector that can change the position of the lower arc segment vertically or horizontally relative to the upper arc segment, the dental appliance is preferably a one-piece device. In most cases, the dental appliance is customized to match the patient's dentition with a target position that works most effectively and comfortably for the patient with OSAHS.

[0116] The effectiveness of dental appliances can be evaluated using any known method. OSAHS symptoms are conventional treatment indicators, which include but are not limited to: snoring, mouth breathing, night coughing, supine insomnia, shallow sleep, sleep fragmentation, nocturia, daytime sleepiness, yawning, headache, chest tightness, hoarseness, irritation of the throat, excessive mucus, dysphagia, dyspnea, heartburn, chest pain, nausea, hypertension and nocturnal hypoxemia. Those symptoms are self-reported in a questionnaire to evaluate the severity and treatment effectiveness of apnea or hypopnea. The apnea-hypopnea index (AHI) and the level of decreased oxygen saturation are also commonly used to indicate severity. AHI is the number of apneas or hypopneas that occur per hour of sleep, and is expressed as the number of events per hour. Mild apnea or hypopnea has an AHI of more than 5 but less than 15, and has a level of decreased oxygen saturation of more than 90%. Moderate apnea or hypopnea has an AHI of more than 15 but less than 30, and has a level of decreased oxygen saturation of 80% to 89%. Severe apnea or hypopnea has an AHI of 30 or more and has an oxygen desaturation level of less than 80%.

[0117] In the absence of additional detailed description, it is believed that those skilled in the art can use the present disclosure to its greatest extent based on the disclosure herein. Therefore, the following specific embodiments should be interpreted as being merely illustrative and not limiting the remainder of the present disclosure in any way. All publications and patent documents cited herein are incorporated by reference in their entirety.

[0118] The dental appliances in Table 1 below were prepared according to the above method 1. Adjusted dental appliances, X max , Y max , X tp , Y tp All are defined above.

[0119] Table 2 below shows examples of the dental appliance of the present invention prepared according to Method 2.

[0120] Table 1.

[0121]

[0122]

[0123] Table 2.

[0124]

[0125] Surprisingly, the dental appliances in Tables 1 and 2 above are effective in curing or alleviating obstructive sleep apnea or hypopnea.

[0126] Other Implementations

[0127] All features disclosed in this specification can be combined in any combination. Each feature disclosed in this specification can be used as an alternative feature replacement for the same, equivalent or similar purpose. Unless otherwise explicitly stated, each feature disclosed is only an example of a general series of equivalent or similar features.

[0128] According to the above description, those skilled in the art can easily determine the essential features of the present invention, and without departing from its spirit and scope, various changes and modifications can be made to the present invention to make it suitable for various uses and conditions. Therefore, other embodiments are also within the scope of the appended claims.

Claims

1. A dental appliance for treating a patient suffering from obstructive sleep apnea or hypopnea, the dental appliance comprising a lower arc segment, an upper arc segment and a connecting segment connecting the lower arc segment and the upper arc segment, in, The patient has mandibular dentition and maxillary dentition, The lower arc segment is conformal to the mandibular dentition, The upper arc segment is conformal to the maxillary dentition, The lower arc segment is located at the target position (X) of the mandibular dentition. tp , Y tp ) corresponding to the position, in, X tp is the target position (X tp , Y tp ) and the reference position (0, 0) of the mandibular dentition, Y tp is the target position (X tp , Y tp ) and the reference position (0, 0), The reference position (0, 0) is the center point of the mandible when the maxillary dentition and the mandibular dentition are fitted together with maximum interdental interdigitation. Y tp =bX tp , b is 1 to 10, Y tp =mY max , m is 5% to 70%, X tp =nX max , n is 5% to 80%, X max is the horizontal distance between the reference position (0, 0) and the maximum forward position, The maximum protrusive position is the position where the mandibular dentition is protruded to its maximum extent. Y max is the vertical distance between the reference position (0, 0) and the maximum mouth opening position, The maximum protrusive position is the position where the mandibular teeth are vertically opened to their maximum limit.

2. The dental appliance of claim 1, wherein m is between 8% and 60%.

3. The dental appliance of claim 2, wherein m is between 12% and 50%.

4. The dental appliance of claim 1, wherein n is between 12% and 70%.

5. The dental appliance of claim 4, wherein n is between 20% and 60%. The dental appliance of claim 1 , wherein b is from 1.2 to 8.

7. The dental appliance of claim 6, wherein b is from 1.5 to 6.

5.

8. The dental appliance according to claim 1, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental appliance has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue.

9. The dental appliance of claim 8, wherein m is between 8% and 60%, n is between 12% and 70%, and b is between 1.2 and 8.

10. The dental appliance of claim 9, wherein m is between 12% and 50%, n is between 20% and 60%, and b is between 1.5 and 6.

5.

11. The dental appliance of claim 1, wherein the lower arc segment, the upper arc segment, or the connecting segment is made of an acrylic polymer or copolymer, an acrylate polymer or copolymer, or a combination thereof.

12. The dental appliance of claim 11, wherein m is between 8% and 60%, n is between 12% and 70%, and b is between 1.2 and 8.

13. The dental appliance of claim 12, wherein m is between 12% and 50%, n is between 20% and 60%, and b is between 1.5 and 6.

5.

14. The dental appliance according to claim 13, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental appliance has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue.

15. The dental appliance of claim 1, wherein m is between 8% and 60%, n is between 12% and 70%, and b is between 1.2 and 8.

16. The dental appliance of claim 15, wherein m is between 12% and 50%, n is between 20% and 60%, and b is between 1.5 and 6.

5.

17. A dental brace according to claim 16, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental brace has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue, and the lower arc segment, the upper arc segment or the connecting segment is made of acrylic polymer or copolymer, acrylate polymer or copolymer, or a combination thereof.

18. The dental appliance of claim 1, wherein X tp 0.2mm to 8mm and Y tp 0.5mm to 20mm.

19. The dental appliance of claim 18, wherein X tp 0.3mm to 6mm and Y tp 0.8mm to 15mm.

20. A dental appliance for treating a patient suffering from obstructive sleep apnea or hypopnea, the dental appliance comprising a lower arc segment, an upper arc segment, and a connecting segment connecting the lower arc segment and the upper arc segment, in, The patient has mandibular dentition and maxillary dentition, The lower arc segment is conformal to the mandibular dentition, The upper arc segment is conformal to the maxillary dentition, The lower arc segment is in an adjusted position (X) with the mandibular dentition. adj , Y adj ) corresponding to the position, in, X adj is the adjustment position (X adj , Y adj ) and the reference position (0, 0) of the mandibular dentition, Y adj is the adjustment position (X adj , Y adj ) and the reference position (0, 0), The reference position (0, 0) is the center point of the mandible when the maxillary dentition and the mandibular dentition are fitted together with maximum interdental interdigitation. Y adj Equal to aX adj , X adj / X max Between 1% and 80%, Y adj / Y max Between 1% and 70%, X max is the horizontal distance between the reference position (0, 0) and the maximum protrusion position of the mandibular dentition, Y max is the vertical distance between the reference position (0, 0) and the maximum mouth opening position of the mandibular dentition, a is equal to Y tp / X tp , X tp is the target position of the mandibular dentition (X tp , Y tp ) and the reference position (0, 0), Y tp is the target position (X tp , Y tp ) and the reference position (0, 0), and The target position (X tp , Y tp ) is the position to which the mandibular dentition moves so that the patient's airway and epiglottis are opened.

21. The dental appliance of claim 20, wherein X adj / X max Between 2% and 75%.

22. The dental appliance of claim 21, wherein X adj / X max Between 3% and 75%.

23. The dental appliance of claim 20, wherein Y adj / Y max Between 1% and 65%.

24. The dental appliance of claim 23, wherein Y adj / Y max Between 2% and 60%.

25. The dental appliance of claim 24, wherein X adj / X max Between 3% and 75%.

26. The dental appliance of claim 20, wherein a is from 0.2 to 15.

27. The dental appliance of claim 26, wherein a is 1 to 10.

28. The dental appliance according to claim 20, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental appliance has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue.

29. The dental appliance of claim 28, wherein X adj / X max Between 2% and 75%, Y adj / Y max Between 1% and 65%, and a is between 0.2 and 15.

30. The dental appliance of claim 29, wherein X adj / X max Between 3% and 75%, Y adj / Y max Between 2% and 60%, and a is 1 to 10.

31. The dental appliance of claim 20, wherein the lower arc segment, the upper arc segment, or the connecting segment is made of an acrylic polymer or copolymer, an acrylate polymer or copolymer, or a combination thereof.

32. The dental appliance of claim 31, wherein X adj / X max Between 2% and 75%, Y adj / Y max Between 1% and 65%, and a is between 0.2 and 15.

33. The dental appliance of claim 32, wherein X adj / X max Between 3% and 75%, Y adj / Y max Between 5% and 60%, and a is 1 to 10.

34. The dental appliance according to claim 33, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental appliance has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue.

35. The dental appliance of claim 20, wherein X adj / X max Between 5% and 80%, Y adj / Y max Between 5% and 70%, and a is 1 to 10.

36. A dental appliance according to claim 35, wherein the lower arc segment and the upper arc segment each have two rear segments and one front segment, the dental appliance has an opening between the lower arc segment and the upper arc segment at their front segments, and the opening has a width of 20% to 50% relative to the maximum width of the patient's tongue, and the lower arc segment, the upper arc segment or the connecting segment is made of acrylic polymer or copolymer, acrylate polymer or copolymer, or a combination thereof.

37. The dental appliance of claim 20, wherein X adj 0.2mm to 8mm and Y adj 0.5mm to 20mm.

38. The dental appliance of claim 37, wherein X adj 0.3mm to 6mm and Y adj 0.8mm to 15mm.

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