Lower jaw advancing device

Abstract

The utility model relates to a lower jaw advancing device which comprises an upper tray assembly and a lower tray assembly, the upper tray assembly comprises an upper support and an upper moldable part, and the lower tray assembly comprises a lower support and a lower moldable part. The stent is designed to engage with the moldable member, and the moldable member is configured to at least partially conform to the teeth and / or gums. In addition, the stent is made of at least two materials with different hardness, and the first material is softer than the second material. The support outer wall is at least partially made of a first material, and the support bottom wall is at least partially made of a second material. According to the design, the comfort and the safety of the mandibular advancement device are improved, so that the use experience of a user is improved, and the treatment effect is enhanced.

Description

Technical Field

[0001] The utility model relates to one or more of the treatment and improvement of respiratory-related diseases, and provides a mandibular advancement device. Background Art

[0002] Obstructive sleep apnea syndrome (OSAS) is a sleep apnea syndrome caused by obstructive lesions of the upper respiratory tract. It is defined as an adult having at least 30 episodes of apnea during 7 hours of night-time sleep, and each episode of apnea lasting at least 10 seconds or more; or the average number of apneas per hour being greater than 5. OSAS is manifested by loud snoring, short-term gasping and apnea lasting more than 10 seconds alternating during sleep. Apnea can cause asphyxia in the user, sometimes waking up suddenly, and can fall asleep again after breathing resumes. The sleep quality is thus severely affected, and the user often feels fatigued and sleepy during the day. In patients with a long course of disease, manifestations such as anxiety and depression may occur. Repeated hypoxia occurs in the user during sleep, and over time, multiple organs and viscera are damaged, and gradually developing will lead to complications in the cardiovascular system, respiratory system, nervous system, endocrine system, urinary system, etc. According to the severity, OSAS can be divided into mild, moderate and severe degrees. The main purpose of treating OSAS is to increase the tension of the respiratory airway, enable normal gas exchange in the respiratory tract, bring oxygen from the external environment into the body, and at the same time discharge carbon dioxide produced by metabolism out of the body. The methods for treating OSAS are generally the following: etiological treatment, developing good living habits, drug treatment, continuous positive airway pressure (CPAP), mandibular advancement device (MAD) treatment, surgical treatment, and other device intervention treatments.

[0003] Among these methods, CPAP treatment is the preferred choice for most people. A continuous positive airway pressure (CPAP) machine is used, and the machine provides a constant and stable air pressure to the airway through a hose, mask, etc., so that the airway does not collapse due to being in a positive pressure state during the entire respiratory cycle, thus keeping the airway unobstructed. However, the bodies of some people cannot tolerate or adapt to the positive pressure airflow provided by the CPAP machine. Secondly, CPAP requires the use of components such as hoses and masks, and these components are tied to the user's nose, face or mouth, which makes it difficult for the user to fall asleep and affects sleep. In addition, the CPAP machine is relatively large in size and difficult to carry, and it is difficult for the user to carry it when traveling. Moreover, CPAP treatment uses more components, and its cleaning scheme is cumbersome and complex. However, if not cleaned properly, it may cause other respiratory diseases caused by bacteria or fungi.

[0004] Surgical treatment of OSAS was once very popular. If the cause of obstruction is clear, the obstruction can be relieved through surgeries such as nasal polypectomy, correction of deviated nasal septum, tonsillectomy, adenoidectomy, etc. Orthognathic surgery is one of the treatment methods for OSAS caused by jaw factors. Due to the forward movement of the maxilla and mandible, parameters such as the volume of the upper airway and the minimum cross-sectional area of the upper airway in the user are significantly increased after the operation compared with before the operation, which can significantly improve the symptoms of OSAS and even achieve the effect of complete disappearance of symptoms. However, surgical treatment has risks, such as postoperative bleeding, infection, and poor postoperative effects.

[0005] Therefore, CPAP and / or surgical treatment may not be the best treatment methods for OSAS.

[0006] Oral appliance (MAD) treatment achieves the treatment effect by indirectly expanding the upper airway by advancing the mandible. MAD treatment can be divided into three categories according to the acting site: soft palate appliance (SPL), tongue retaining device (TRD), and mandibular advancement device. The soft palate appliance is fixed to the maxillary teeth and extends backward, directly acting on the soft palate and uvula, reducing their sagging, reducing the contact between the overly long soft palate and uvula and the root of the tongue and posterior pharyngeal wall, and preventing pharyngeal stenosis or obstruction; at the same time, it can reduce the tremor of the soft palate and reduce snoring. However, since the soft palate is easily touched and causes a sense of nausea, it requires long-term training to tolerate, so it is rarely used. The tongue retaining device can prevent the tongue from falling back by generating negative pressure in the spherical object in front of the appliance, so as to widen the airway behind the tongue and behind the soft palate. However, the comfort and fixation of the tongue retaining device are poor, and the user's tolerance is not good, so it is also rarely used. The mandibular advancement device enlarges the oropharynx by keeping the mandible in a protruded state and indirectly drives the tongue body to move forward, widening the airway behind the tongue, and can also reduce the backward pressure of the tongue on the soft palate, widening the airway behind the soft palate. The more common one is the adjustable mandibular advancement device. If the treatment effect is not good, the mandibular advancement distance can be increased to expand the airway; if discomfort occurs during the treatment process, the advancement amplitude can be reduced. This adjustable mandibular advancement device can not only improve the user's tolerance but also achieve an effective treatment effect.

[0007] There are many challenges in the design of the mandibular advancement device. 1) Stability: During sleep, the movement of the user or the unconscious opening and closing of the mouth may cause the mandibular advancement device to fall off, thus affecting the sustainability of the treatment; 2) Applicability: Since the shapes and sizes of everyone's mouths and teeth are different, and the high cost of customizing the mandibular advancement device, it faces great challenges to design a mandibular advancement device applicable to most people; 3) Comfort: When biting the mandibular advancement device, the inside of the cheek and the tongue are prone to rubbing against the mandibular advancement device, resulting in injury, and wearing the mandibular advancement device for a long time and having a long biting time may cause problems of tooth discomfort.

[0008] Therefore, in order to overcome these challenges and design a more stable, suitable for most people and comfortable mandibular advancement device, a comprehensive design is required. This includes, but is not limited to, considering material selection to ensure that the mandibular advancement device has sufficient strength and comfort, while having appropriate flexibility to adapt to different oral morphologies. By comprehensively considering these factors, the treatment effect and use comfort of the mandibular advancement device can be improved, thus better meeting the needs of users. Summary of the Utility Model

[0009] To solve the above technical problems, the technical solution adopted by the present utility model is to provide a mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, including:

[0010] An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper moldable component;

[0011] A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower moldable component;

[0012] Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper moldable component and the lower moldable component;

[0013] The upper moldable component and the lower moldable component are configured to at least partially conform to the teeth and / or gums;

[0014] The upper bracket and the lower bracket are made of at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material;

[0015] The upper bracket and the lower bracket have a bottom wall;

[0016] Wherein, the bottom wall of the upper bracket has a first end and a second end, and at least part of the area between the first end and the second end forms an approximate arc;

[0017] The bottom wall of the lower bracket has a third end and a fourth end, and at least part of the area between the third end and the fourth end forms an approximate arc.

[0018] In one embodiment, the shape of the upper tray assembly is approximately arc-shaped, U-shaped or arched.

[0019] In one embodiment, the shape of the lower tray assembly is approximately arc-shaped, U-shaped or arched.

[0020] In one embodiment, the first end, the second end, the third end, and the fourth end are made of the first material.

[0021] In one embodiment, the hardness of the second material is higher than that of the first material.

[0022] The present utility model also discloses a mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising:

[0023] An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper moldable member;

[0024] A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower moldable member;

[0025] Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper moldable member and the lower moldable member;

[0026] The upper bracket and the lower bracket are made of at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material;

[0027] The upper bracket and the lower bracket have outer walls;

[0028] Wherein, at least a part of the outer wall comprises the first material.

[0029] In one embodiment, the outer wall only comprises the first material.

[0030] In one embodiment, in the part of the outer wall in contact with the oral cavity, the area of the first material is larger than the area of the second material.

[0031] In one embodiment, the first material includes silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA.

[0032] In one embodiment, the second material includes PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nitinol alloy, aluminum alloy.

[0033] In one embodiment, the outer wall forms an angle of 20 - 150° with the horizontal plane.

[0034] The present utility model also discloses a mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising:

[0035] An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper moldable member;

[0036] A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower moldable member;

[0037] Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper moldable member and the lower moldable member;

[0038] The upper bracket and the lower bracket are made of at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material.

[0039] The upper bracket and the lower bracket have a bottom wall.

[0040] Wherein, at least part of the bottom wall comprises the second material.

[0041] In one embodiment, the bottom wall only comprises the second material.

[0042] In one embodiment, the thickness of the second material in the bottom wall is at least 0.3 mm.

[0043] In one embodiment, the projected area of the bottom wall on the horizontal plane is at least 9 cm 2 .

[0044] In one embodiment, the first material and the second material are fixed by means of crimping, overmolding, snap-fitting, bonding, hot melting, screwing, or hooking.

[0045] The present utility model further discloses a mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising:

[0046] An upper tray assembly configured to be adjacent to a part of the user's upper dentition, comprising an upper bracket and an upper shapeable member;

[0047] A lower tray assembly configured to be adjacent to a part of the user's lower dentition, comprising a lower bracket and a lower shapeable member;

[0048] Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper shapeable member and the lower shapeable member;

[0049] The upper bracket and the lower bracket are made of at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material;

[0050] The upper bracket and the lower bracket have a bottom wall and an outer wall;

[0051] The upper bracket and the lower bracket have one or more of the following characteristics:

[0052] The volume ratio range of the first material and the second material is 0.05 - 20;

[0053] The thickness range of at least part of the outer wall is 0.3 - 6 mm;

[0054] The thickness range of at least part of the bottom wall is 0.3 - 6 mm.

[0055] In one embodiment, the height in the middle of the outer wall is greater than the heights at both ends of the outer wall.

[0056] In one embodiment, the width in the middle of the outer wall is less than the widths at both ends of the outer wall.

[0057] In one embodiment, the upper bracket includes a first outer wall and a second outer wall, and the lower bracket includes a third outer wall and a fourth outer wall.

[0058] In one embodiment, the second outer wall only includes the first material, and the first outer wall includes the second material.

[0059] In one embodiment, the third outer wall only includes the first material, and the fourth outer wall includes the second material.

[0060] Implementing the mandibular advancement device of the present utility model has at least the following beneficial effects:

[0061] 1) The brackets of existing mandibular advancement devices on the market are usually made of only one material. For a bracket made only of a rigid material, the exposed rigid part is likely to scrape the inside of the oral cavity during wearing, causing irritation or even injury to the soft tissues or the tongue inside the oral cavity. Secondly, if the entire mandibular advancement device is made only of a malleable material or other softer materials, it will result in insufficient supporting force during occlusion. In addition, the lower tray assembly needs to move forward relative to the upper tray assembly, and they need to be fixed to each other. Softer materials are prone to deformation, which may cause the forward movement distance to change, leading to easy separation of the upper and lower tray assemblies and affecting the treatment effect. To solve this problem, the present utility model adopts an innovative design: the bracket has at least two materials with different hardnesses. Among them, the outer wall of the bracket is mainly composed of a first material, which is relatively soft and helps to reduce the scraping of the inside of the oral cavity during wearing. At least part of the bottom wall of the bracket is made of a second material with a higher hardness, which provides the supporting force required during occlusion and the stability for fixing the bracket. In addition, a certain angle is formed between the outer wall of the bracket and the horizontal plane, which can adapt to the natural angle of the anterior teeth tilting towards the labial side and better fit the shape of the teeth. Through this design, both the supporting force during occlusion is ensured, and the upper and lower tray assemblies can be firmly connected, reducing the possibility of the device falling off, thereby ensuring good effects of the mandibular advancement device during the treatment process.

[0062] 2) When the user uses the mandibular advancement device, the lower tray assembly moves forward relative to the upper tray assembly to achieve the effect of mandibular advancement. However, the forward movement may cause congestion inside the oral cavity. Especially when the forward movement distance is large, it may cause contact between the deep part of the oral cavity and the bracket, resulting in a sore feeling and a foreign body sensation. Therefore, the outer wall of the bracket is mostly made of a first material. Compared with traditional rigid materials, this first material is softer and more deformable, and can better conform to the shape of the inner part of the oral cavity, thus providing a more comfortable wearing experience. In addition, the two ends of the bracket also use the softer first material to ensure the comfort of the mandibular joint and / or the deep part of the oral cavity. This design helps to improve the comfort of using the mandibular advancement device, reduce the discomfort of the user, improve the user experience of the user, and thus better improve the treatment effect.

[0063] 3) The mandibular advancement device usually needs to be worn for a long time during sleep. The long-term wearing and occlusion may cause the user's oral cavity or teeth to feel sore. In addition, when wearing the mandibular advancement device, the lower tray assembly moves forward relative to the upper tray assembly to achieve the effect of mandibular advancement. During the forward movement, the lower dentition is subjected to the traction force of forward movement, and the lower tray assembly is subjected to the reaction force of the lower dentition to restore its shape; the upper dentition is subjected to the traction force of backward movement, and the upper tray assembly is subjected to the reaction force of the upper dentition to restore its shape. Therefore, the larger stress surface of the lower tray assembly faces the lingual side, and the larger stress surface of the upper tray assembly faces the labial side. The present utility model provides an improved bracket design. The outer wall of the bracket is made of different materials for different stress directions, and most of the parts that are easily in contact with the oral soft tissues are made of the softer first material. Compared with the traditional integral rigid material, this design can provide a more comfortable stress surface, reduce the discomfort of the oral cavity and teeth, and thus improve the user experience of the user.

[0064] 4) The mandibular advancement devices on the existing market still have the problem of being prone to falling off. A large number of user feedback shows that during sleep, the mandibular advancement device often separates from the oral cavity, resulting in the device falling off. Through test analysis, it is found that this falling-off problem is mainly due to the fact that the lower tray assembly needs to move forward relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep, and these situations may all cause the mandibular advancement device to be prone to falling off. In addition, the outer walls of the brackets on the market are mostly made of rigid materials, and the exposed rigid materials are more likely to slide after contacting the oral cavity, further increasing the possibility of the mandibular advancement device falling off. To solve this problem, the present utility model provides an improved bracket design, the outer wall of which includes the softer first material. The friction coefficient of this first material is larger than that of the traditional rigid material, thereby increasing the friction with the oral cavity. By increasing the friction, the mandibular advancement device can be more firmly fixed in the oral cavity, reducing the possibility of falling off and improving the stability and sustainability of the device during sleep. Description of the Drawings

[0065] Figure 1 Schematic structural diagram of the mandibular advancement device in an embodiment of the present utility model;

[0066] Figure 2 Exploded schematic structural diagram of the mandibular advancement device in multiple embodiments of the present utility model;

[0067] Figure 3 Schematic diagrams of the horizontal plane, sagittal plane, and coronal plane in multiple embodiments of the present utility model;

[0068] Figure 4 Top view of the separation of the upper bracket and the lower bracket in multiple embodiments of the present utility model;

[0069] Figure 5 In an embodiment of the present utility model, the upper bracket is in Figure 4 Cross-sectional view in the A-A direction;

[0070] Figure 6 Rear view of the combination of the upper bracket and the lower bracket in multiple embodiments of the present utility model;

[0071] Figure 7 In an embodiment of the present utility model, the bracket is in Figure 6 Cross-sectional view in the D-D direction;

[0072] Figure 8 In an embodiment of the present utility model, the upper bracket is in Figure 4 Cross-sectional view in the B-B direction;

[0073] Figure 9 Partial cross-sectional schematic diagram of the angle between the outer wall of the bracket and the horizontal plane in the first embodiment of the present utility model;

[0074] Figure 10 In the first embodiment of the present utility model, the upper bracket is in Figure 4 Cross-sectional schematic diagrams in the A-A direction and the C-C direction;

[0075] Figure 11 Partial cross-sectional schematic diagram formed by the outer wall of the bracket in the first embodiment of the present utility model;

[0076] Figure 12 Partial cross-sectional schematic diagram of the outer wall of the bracket in the second embodiment of the present utility model;

[0077] Figure 13 Partial cross-sectional schematic diagram of the outer wall of the bracket in the second embodiment of the present utility model. Detailed implementation manners

[0078] To make the above objects, features, and advantages of the present utility model more apparent and understandable, the following provides a detailed description of the specific embodiments of the present utility model in conjunction with the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present utility model. However, the present utility model can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present utility model. Therefore, the present utility model is not limited by the specific embodiments disclosed below.

[0079] The present utility model relates to a mandibular advancement device, aiming at the limitation that most of the brackets of mandibular advancement devices on the market are made of only one material. To solve this problem, the present utility model adopts an innovative design - the bracket of the mandibular advancement device is made of two materials with different softness and hardness. Through this design, the comfort and safety of the mandibular advancement device can be improved, thereby enhancing the user experience and treatment effect.

[0080] The present utility model provides a mandibular advancement device 1 for preventing or reducing snoring and / or obstructive sleep apnea during sleep, including an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a part of the user's upper dentition, including an upper bracket 21 and an upper moldable member 22, and its main function is to support the teeth of the upper jaw. The lower tray assembly 3 is configured to be adjacent to a part of the user's lower dentition, including a lower bracket 31 and a lower moldable member 32, and its main function is to support the teeth of the lower jaw. Among them, the shapes of the upper tray assembly 2 and the lower tray assembly 3 are approximately arc-shaped, U-shaped, or arched, conforming to the general arched shape of the user's dentition curve. The upper tray assembly 2 and the lower tray assembly 3 together constitute the mandibular advancement device 1, and by supporting the upper and lower dentitions, adjusting the front-to-back distance, and applying a slight pressure to the teeth, the effect of treating OSAS is achieved.

[0081] The upper moldable member 22 and the lower moldable member 32 are configured to at least partially conform to the teeth and / or gums. The upper moldable member 22 and the lower moldable member 32 are generally approximately arc-shaped, U-shaped, or arched, similar to the shape of the dental arch, so as to ensure full contact between the upper moldable member 22 and the lower moldable member 32 and the teeth and gums. Some parts of the upper moldable member 22 and the lower moldable member 32 may have a convex or concave design to meet the requirements of different tooth shapes and sizes. The upper moldable member 22 and the lower moldable member 32 are generally made of elastic materials such as silicone rubber, PU, PVA, EVA, etc., and the materials are required to have good biocompatibility, be soft and comfortable, not cause damage to the oral cavity, and be suitable for long-term wearing in the oral cavity.

[0082] There are several different forms of shapeable components on the market currently. Commonly, they are made in a hospital according to the dental impressions of the user. By precisely customizing the shapeable components in this way, they can better fit the user's teeth, thus ensuring better comfort and optimal treatment effects. However, customizing shapeable components requires professional technology and equipment, with high costs and long construction periods. Moreover, if significant adjustments or changes are needed after the shapeable components are made, it may be rather difficult and require remaking or reprocessing. Therefore, there is also a thermoplastic shapeable component that is very popular on the market. The production process of the thermoplastic shapeable component is relatively simple. It only needs to heat and soften the material and bite to shape the required form. And after shaping, it can be reheated to slightly adjust the shape. In this way, both the production speed is relatively fast and the cost is reduced. Due to the simple production process and the lack of professional equipment assistance, the accuracy and adaptability of the thermoplastic shapeable component may be relatively low, and there are also limitations in the selection of materials. Special thermoplastic materials need to be used, but these materials may have limitations in terms of hardness, comfort, etc. The upper shapeable component 22 and the lower shapeable component 32 provided in the present utility model include, but are not limited to, custom shapeable components and thermoplastic shapeable components.

[0083] Specifically, please refer to Figures 1 to 4 , the upper bracket 21 and the lower bracket 31 are respectively configured to engage and support the upper shapeable component 22 and the lower shapeable component 32, and can provide stable supporting forces in the user's oral cavity. They may also have an adjustment function, allowing adjustment according to the user's needs. The shapes of the upper bracket 21 and the lower bracket 31 are usually similar to those of the upper shapeable component 22 and the lower shapeable component 32, and are also approximately arc-shaped, U-shaped or arched to ensure a fit with the shape of the teeth inside the oral cavity.

[0084] The upper bracket 21 and the lower bracket 31 are made of at least two materials with different hardnesses, and the hardness of the first material 4 is lower than that of the second material 5. The first material 4 is usually a material with softness and good elasticity, including, but not limited to, silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA. The first material 4 usually has good biocompatibility and can contact the inside of the oral cavity without causing allergies or other adverse reactions. Moreover, the soft material is more comfortable than traditional rigid materials and is more suitable for long-term wearing and biting, which helps to reduce the discomfort of the user and oral irritation. Although the first material 4 is relatively soft, it also has a certain degree of wear resistance and can withstand the tension and friction in the oral cavity during wearing, thereby improving the service life of the overall component. The hardness of the second material 5 is higher than that of the first material 4. It usually has relatively high hardness and can withstand greater pressures to ensure that the upper bracket 21 and the lower bracket 31 are not easily deformed or damaged during wearing and biting, and maintain the structural stability of the brackets. The second material 5 includes, but is not limited to, PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nickel-titanium alloy, aluminum alloy.

[0085] As Figure 5 shown, the first material 4 and the second material 5 on the upper bracket 21 and the lower bracket 31 are usually fixed in a non-detachable manner. Crimping (applying pressure to tightly combine the two), overmolding, snap-fitting (constructing snaps on the first material 4 and the second material 5 respectively for engagement), bonding (such as adhesives), heat melting (heating the first material 4 to melt and then cooling and fixing it on the second material 5), or using additional fixing fittings such as screws, hooks, etc. can be used for the fixing method. The connection method can adopt one form, or even combine two or more forms to achieve the function of connecting and / or fixing the first material 4 and the second material 5. Selecting the appropriate connection method depends on specific design requirements, material properties, and usage environments to ensure firm, reliable, and durable connection, and it is necessary to facilitate installation during production and adjustment operations by users. Among them, the preferred fixing method is overmolding. Overmolding can tightly fix the first material 4 and the second material 5 together, providing a more stable fixing effect, avoiding detachment or loosening between materials. Secondly, it can also prevent external substances from entering or remaining in the gaps between materials. Such a sealing property can effectively protect the interior of the materials from residual bacteria or cleaning residues and can also extend the service life.

[0086] The upper bracket 21 and the lower bracket 31 include bottom walls 211, 311. As Figure 6 , Figure 7 shown, the bottom walls 211, 311 are usually horizontal. The tops of the bottom walls 211, 311 are fitted with the upper plastically deformable part 22 and the lower plastically deformable part 32, and the bottoms form a channel with the bottoms of the other bottom walls 211, 311. When the user wears the mandibular advancement device 1, the device will not be completely closed, and the external air flow can enter the user's oral cavity through the channel, without restricting the free flow of the air flow in the user's oral cavity. At the same time, it also meets the usage needs of users who are accustomed to breathing through their mouths during sleep, avoiding the risk of suffocation. If heat-meltable upper plastically deformable part 22 and lower plastically deformable part 32 are used, shaping needs to be carried out by biting the upper and lower tray assemblies 2, 3, and without providing sufficient vertical support force, it may lead to difficult or even failed shaping process. Secondly, the lower tray assembly 3 needs to be advanced relative to the upper tray assembly 2, and the upper bracket 21 and the lower bracket 31 need to be fixed to each other. If softer materials are used, the softer materials are prone to deformation, resulting in a change in the advancement distance, which will not only affect the treatment effect but also cause the upper bracket 21 and the lower bracket 31 to be easily separated. Therefore, in the present utility model, an improved upper bracket 21 and lower bracket 31 are provided, and their bottom walls 211, 311 are at least partially composed of the second material 5 to provide sufficient vertical support force for the upper plastically deformable part 22 and the lower plastically deformable part 32. The area of the bottom walls 211, 311 in the horizontal plane is at least 9 cm 2, and at least part of the thickness ranges from 0.3 to 6 mm, that is Figure 7 d1 shown in. The thickness of the second material 5 included in the bottom walls 211 and 311 is at least 0.3 mm, that is Figure 7 d2 shown in. The sum of the overall weights of the upper bracket 21 and the lower bracket 31 is 3 - 50 g, and the volume ratio range of the first material 4 and the second material 5 in the upper bracket 21 and the lower bracket 31 is 0.05 - 20. Preferably, the bottom walls 211 and 311 of the bracket only include the second material 5 with a thickness of 1 - 2 mm. Through this design, it can not only ensure the required supporting force and stiffness of the mandibular advancement device 1, but also avoid the upper bracket 21 and the lower bracket 31 from being too heavy, thereby reducing the weight of the mandibular advancement device 1 and the burden on the oral cavity.

[0087] As Figure 4 , Figure 8 shown, the bottom wall 211 of the upper bracket has a first end 214 and a second end 215, and at least part between the first end 214 and the second end 215 forms an approximate arc, U shape or arch; the bottom wall 311 of the lower bracket has a third end 314 and a fourth end 315, and at least part between the third end 314 and the fourth end 315 forms an approximate arc, U shape or arch. When the user uses the mandibular advancement device 1, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. However, the forward movement may cause crowding inside the oral cavity. Especially when the forward movement distance is large, it may cause contact with the upper bracket 21 and the lower bracket 31 in the deep part of the oral cavity, causing a sense of soreness and foreign body sensation. Therefore, the two ends 214, 215, 314, 315 of the bracket are made of the relatively soft first material 4 to ensure the comfort of the mandibular joint and / or the deep part of the oral cavity. This design helps to improve the use comfort of the mandibular advancement device 1, reduce the discomfort of the user, improve the user experience of the user, and thus better improve the treatment effect.

[0088] The upper bracket 21 and the lower bracket 31 include outer walls 212, 213, 312, 313. As Figures 6 to 8 shown, at least part of the bracket outer walls 212, 213, 312, 313 is composed of the relatively soft first material 4, and in the part where the outer walls 212, 213, 312, 313 contact the oral cavity, the area of the first material 4 is larger than the area of the second material 5. Compared with the traditional rigid material, the first material 4 is more easily deformed and can better fit the shape of the oral cavity interior, thereby providing a more comfortable wearing experience.

[0089] When wearing the mandibular advancement device 1, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the forward movement, the lower dentition is subjected to a forward traction force, and the lower tray assembly 3 is subjected to a reaction force from the lower dentition to restore its shape. The upper dentition is subjected to a backward traction force, and the upper tray assembly 2 is subjected to a reaction force from the upper dentition to restore its shape. Therefore, the force-bearing surface of the lower tray assembly 3 is located near the lingual side, and the force-bearing surface of the upper tray assembly 2 is located near the labial side. And because the offset of the upper tray assembly 2 relative to the original position of the teeth is small, the reaction force received by the upper tray assembly 2 is less than the reaction force received by the lower tray assembly 3. There is still a problem of easy detachment with the existing mandibular advancement devices on the market. Feedback from a large number of users shows that during sleep, the mandibular advancement device often separates from the oral cavity, resulting in the device falling off. Through test analysis, it is found that this detachment problem is mainly due to the fact that the lower tray assembly needs to move forward relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep, and the lack of an outer wall of the bracket leads to insufficient support force. All these situations may cause the mandibular advancement device to be easily detached. In addition, most of the outer walls of the brackets on the market are made of rigid materials, and the exposed rigid materials are more likely to slide after contacting the oral cavity, further increasing the possibility of the mandibular advancement device falling off.

[0090] To solve these problems, the upper bracket 21 and the lower bracket 31 in the present utility model have outer walls 212, 213, 312, 313, providing sufficient support force for the mandibular advancement device 1. In addition, most of the parts of the outer walls 212, 213, 312, 313 in contact with the oral cavity are made of the first material 4. The friction coefficient of the first material 4 is larger than that of traditional rigid materials, thereby increasing the friction with the oral cavity. By increasing the friction, the mandibular advancement device 1 can be more firmly fixed in the oral cavity, reducing the possibility of detachment, and improving the stability and sustainability of the device during sleep. This design helps to improve the use comfort of the mandibular advancement device 1, relieve the discomfort of the user, improve the user experience of the user, and thus better improve the treatment effect.

[0091] The following illustrates several structures of the mandibular advancement device 1 of the present utility model with specific examples.

[0092] Embodiment 1

[0093] The mandibular advancement device 1 of this embodiment includes an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a part of the upper dentition of the user and includes an upper bracket 21 and an upper moldable member 22. The lower tray assembly 3 is configured to be adjacent to a part of the lower dentition of the user and includes a lower bracket 31 and a lower moldable member 32.

[0094] Specifically, as Figure 2As shown, the upper plastic component 22 and the lower plastic component 32 are configured to at least partially conform to the teeth and / or gums. The upper bracket 21 and the lower bracket 31 are respectively configured to engage and support the upper plastic component 22 and the lower plastic component 32. The upper bracket 21 and the lower bracket 31 are made of at least two materials with different hardnesses, and the hardness of the first material 4 is lower than that of the second material 5.

[0095] The upper bracket 21 and the lower bracket 31 include bottom walls 211, 311 and outer walls 212, 213, 312, 313. As Figure 4 , Figure 6 shown, the upper bracket 21 includes a bottom wall 211, a first outer wall 212 and a second outer wall 213, and the lower bracket 31 includes a bottom wall 311, a third outer wall 312 and a fourth outer wall 313. The first outer wall 212 and the third outer wall 312 are configured to face the labial side, and the second outer wall 213 and the fourth outer wall 313 are configured to face the lingual side.

[0096] In this embodiment, the outer walls 212, 213, 312, 313 of the bracket are connected to the bottom walls 211, 311. As Figure 9 shown, the upper plastic component 22 and the lower plastic component 32 are contacted through the structures of the first outer wall 212 - bottom wall 211 - second outer wall 213 and the third outer wall 312 - bottom wall 311 - fourth outer wall 313. Each tooth has a certain angular difference and is not necessarily perpendicular to the horizontal plane. For example, the anterior teeth (central incisors and lateral incisors) usually have a certain labial inclination relative to the horizontal vertical plane, and the inclination angle is about 10 - 25°; the inclination angle of the canine teeth (in the labial direction) is usually between 5 - 15°; and the inclination angle of the molars (in the labial direction) is usually between 0 - 5°. The anterior teeth and canine teeth have a larger angle relative to the horizontal vertical plane, while the molars have a smaller angle relative to the horizontal vertical plane. This results in different support forces required for different teeth during the occlusion process. Therefore, the outer walls 212, 213, 312, 313 form an angle of 20° - 150° with the horizontal plane (towards the direction away from the bottom walls 211, 311), that is Figure 9 the angle α in

[0097] The positions of the teeth in the oral cavity are different. Considering the differences in the sizes of different teeth, the heights and widths of the outer walls 212, 213, 312, 313 are adjusted accordingly. The central incisor part is usually narrower and longer, suitable for cutting and tearing food, and the molar part is usually wider and thicker, more suitable for chewing and grinding food. Therefore, as Figure 10As shown, the outer walls 212, 213, 312, and 313 are generally higher in the middle (the tangent point position with the sagittal plane) and narrower in the front-back distance (the distance between the first outer wall 212 and the second outer wall 213 or the distance between the third outer wall 312 and the fourth outer wall 313), lower at both ends and wider in the front-back distance, that is, the height in the middle of the outer walls 212, 213, 312, 313 is greater than the height at both ends ( Figure 10 h1 in Figure 10 ), and the width in the middle is less than the width at both ends ( Figure 10 w1 in

[0098] ). The higher and narrower part in the middle can accommodate and fix the narrow and long central incisors. Although the molar part is also relatively long, it is wider and thicker. It is set to be lower and wider at both ends to prevent the molars from being too wide and squeezing the outer walls 212, 213, 312, 313.

[0098] When wearing the mandibular advancement device 1, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. As Figure 11 shown, during the forward movement, the lower dentition is subjected to the forward traction force, and the lower bracket 31 is subjected to the reaction force of the lower dentition to restore its shape. The upper dentition is subjected to the backward traction force, and the upper bracket 21 is subjected to the reaction force of the upper dentition to restore its shape. Therefore, the force-bearing surface of the lower bracket 31 is located near the lingual side, and the force-bearing surface of the upper bracket 21 is located near the labial side. And because the offset of the upper bracket 21 relative to the original position of the teeth is small, the reaction force received by the upper bracket 21 is less than the reaction force received by the lower bracket 31. Therefore, the larger force-bearing surface of the upper bracket 21 is the first outer wall 212, and the larger force-bearing surface of the lower bracket 31 is the fourth outer wall 313.

[0099] In this embodiment, the hardness of the first material 4 is relatively low and it is difficult to provide sufficient support force. Most of the parts of the bracket outer walls 212, 213, 312, 313 in contact with the oral cavity are composed of the first material 4 and at least partially include the second material 5, that is, the first outer wall 212 and the second outer wall 213 at least partially include the first material 4 and the second material 5, and the third outer wall 312 and the fourth outer wall 313 at least partially include the first material 4 and the second material 5. Among them, the thickness range of the outer walls 212, 213, 312, 313 is at least partially 0.3 - 6 mm, that is Figure 12 w2 in Figure 12 . Preferably, the thickness of the outer walls 212, 213, 312, 313 is 1.2 - 2 mm, and the thickness of the second material 5 in the first outer wall 212, the second outer wall 213, the third outer wall 312, and the fourth outer wall 313 is 1 mm, that is Figure 12 w3 in

[0100] Due to the different characteristics of the materials, the supporting forces required for the upper and lower tray assemblies 2 and 3 are different. In other embodiments, the compositions of the outer walls 212, 213, 312, and 313 of the brackets may be different. For example, the upper bracket 21 may not have the first outer wall 212 and / or the second outer wall 213, and the lower bracket 31 may not have the third outer wall 312 and / or the fourth outer wall 313.

[0101] Embodiment 2

[0102] The mandibular advancement device 1 of this embodiment includes an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a part of the user's upper dentition and includes an upper bracket 21 and an upper shapeable member 22. The lower tray assembly 3 is configured to be adjacent to a part of the user's lower dentition and includes a lower bracket 31 and a lower shapeable member 32.

[0103] Specifically, as Figure 2 shown, the upper shapeable member 22 and the lower shapeable member 32 are configured to at least partially conform to the teeth and / or gums. The upper bracket 21 and the lower bracket 31 are respectively configured to engage and support the upper shapeable member 22 and the lower shapeable member 32. The upper bracket 21 and the lower bracket 31 are made of at least two materials with different hardnesses, and the hardness of the first material 4 is lower than that of the second material 5.

[0104] The upper bracket 21 and the lower bracket 31 include bottom walls 211, 311 and outer walls 212, 213, 312, 313. As Figure 4 , Figure 6 shown, the upper bracket 21 includes a bottom wall 211, a first outer wall 212 and a second outer wall 213, and the lower bracket 31 includes a bottom wall 311, a third outer wall 312 and a fourth outer wall 313. The first outer wall 212 and the third outer wall 312 are configured to face the labial side, and the second outer wall 213 and the fourth outer wall 313 are configured to face the lingual side.

[0105] When wearing the mandibular advancement device, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the forward movement, the lower dentition is subjected to a forward traction force, and the lower bracket 31 is subjected to a reaction force from the lower dentition to restore its shape. The upper dentition is subjected to a backward traction force, and the upper bracket 21 is subjected to a reaction force from the upper dentition to restore its shape. Therefore, the force-bearing surface of the lower bracket 31 is at a position close to the lingual side, and the force-bearing surface of the upper bracket 21 is at a position close to the labial side. And since the offset of the upper bracket 21 from the original position of the teeth is relatively small, the reaction force received by the upper bracket 21 is less than the reaction force received by the lower bracket 31. Therefore, the larger force-bearing surface of the upper bracket 21 is the first outer wall 212, and the larger force-bearing surface of the lower bracket 31 is the fourth outer wall 313.

[0106] In this embodiment, the first material 4 has a certain hardness and can provide partial support force, but more support force is still required from the second material 5 on the larger force-bearing surface. AsFigure 12 As shown, the first outer wall 212 and the fourth outer wall 313 include the second material 5 and the first material 4, and the second outer wall 213 and the third outer wall 312 only include the first material 4. On the larger force-bearing surface, the second material 5 and the first material 4 together form the outer walls 212 and 313 to provide sufficient support force; on the smaller force-bearing surface, only the first material 4 is needed to provide support force for the outer walls 213 and 312. Among them, at least part of the thickness range of the outer walls 212, 213, 312, and 313 is 0.3 - 6 mm, that is Figure 12 w2 in Figure 12 ; preferably, the thickness of the outer walls 212, 213, 312, and 313 is 1.2 - 2 mm, and the thickness of the second material 5 in the first outer wall 212 and the fourth outer wall 313 is 1 mm, that is

[0107] Embodiment 3

[0108] The mandibular advancement device 1 of this embodiment includes an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a part of the user's upper dentition and includes an upper bracket 21 and an upper moldable member 22. The lower tray assembly 3 is configured to be adjacent to a part of the user's lower dentition and includes a lower bracket 31 and a lower moldable member 32. Specifically, as Figure 2 shown, the upper moldable member 22 and the lower moldable member 32 are configured to at least partially conform to the teeth and / or gums. The upper bracket 21 and the lower bracket 31 are respectively configured to engage and support the upper moldable member 22 and the lower moldable member 32. The upper bracket 21 and the lower bracket 31 are made of at least two materials with different hardnesses, and the hardness of the first material 4 is lower than that of the second material 5.

[0109] The upper bracket 21 and the lower bracket 31 include a bottom wall 211, 311 and outer walls 212, 213, 312, 313. As Figure 4 、 Figure 6 shown, the upper bracket 21 includes a bottom wall 211, a first outer wall 212 and a second outer wall 213, and the lower bracket 31 includes a bottom wall 311, a third outer wall 312 and a fourth outer wall 313. The first outer wall 212 and the third outer wall 312 are configured to face the lip side, and the second outer wall 213 and the fourth outer wall 313 are configured to face the tongue side.

[0110] When wearing the mandibular advancement device, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the forward movement, the lower dentition is subjected to a forward traction force, and the lower bracket 31 is subjected to a reaction force from the lower dentition to restore its shape. The upper dentition is subjected to a backward traction force, and the upper bracket 21 is subjected to a reaction force from the upper dentition to restore its shape. Therefore, the force-bearing surface of the lower bracket 31 is located near the lingual side, and the force-bearing surface of the upper bracket 21 is located near the labial side. Moreover, since the offset of the upper bracket 21 relative to the original position of the teeth is small, the reaction force received by the upper bracket 21 is smaller than the reaction force received by the lower bracket 31. Therefore, the larger force-bearing surface of the upper bracket 21 is the first outer wall 212, and the larger force-bearing surface of the lower bracket 31 is the fourth outer wall 313.

[0111] In this embodiment, the first material 4 has a relatively large hardness and can provide sufficient supporting force. As Figure 13 shown, the first outer wall 212, the second outer wall 213, the third outer wall 312, and the fourth outer wall 313 only include the first material 4. Among them, the thickness range of at least part of the outer walls 212, 213, 312, 313 is 0.3 - 6 mm, that is Figure 13 w2 in. Preferably, the thickness of the outer walls 212, 213, 312, 313 is 1.2 - 2 mm. This design can not only ensure the required supporting force but also avoid being too heavy, and retain the comfort of the first material 4 for the oral cavity, thereby avoiding increasing the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

[0112] In addition, the technical features in the above embodiments can be combined as needed to obtain the mandibular advancement device 1 including all or part of the above technical features.

[0113] Implementing the mandibular advancement device 1 of the present utility model has at least the following beneficial effects:

[0114] 1) The brackets of existing mandibular advancement devices on the market are usually made of only one material. For a bracket made of only rigid material, the exposed rigid parts are likely to scrape the inner part of the mouth during wearing, causing irritation or even injury to the soft tissues or tongue inside the mouth. Secondly, if the entire mandibular advancement device 1 is made of only malleable material or other softer materials, it will result in insufficient supporting force during occlusion. In addition, the lower tray assembly 3 needs to move forward relative to the upper tray assembly 2, and the two need to be fixed to each other. Softer materials are prone to deformation, which may cause the forward movement distance to change, leading to easy separation of the upper and lower tray assemblies 2 and 3 and affecting the treatment effect. To solve this problem, the utility model adopts an innovative design: the upper bracket 21 and the lower bracket 31 are made of at least two materials with different hardnesses. Among them, the outer walls 212, 213, 312, and 313 of the brackets are mainly composed of the first material 4, which is relatively soft and helps to reduce the scraping of the inner part of the mouth during wearing. The bottom walls 211 and 311 of the brackets are at least partially made of the second material 5 with higher hardness, and the second material 5 provides the supporting force required during occlusion and the stability of fixing the upper bracket 21 and the lower bracket 31. In addition, a certain angle is formed between the outer walls 212, 213, 312, and 313 of the brackets and the horizontal plane, which can adapt to the natural angle of the anterior teeth tilting towards the labial side and better fit the shape of the teeth. Through this design, not only the supporting force during occlusion is ensured, but also the upper and lower tray assemblies 2 and 3 can be firmly connected, reducing the possibility of device detachment, thus ensuring good effects of the mandibular advancement device 1 during the treatment process.

[0115] 2) When the user uses the mandibular advancement device 1, the lower tray assembly 3 moves forward relative to the upper tray assembly 1 to achieve the effect of mandibular advancement. However, the forward movement may cause congestion inside the mouth. Especially when the forward movement distance is large, it may cause contact between the deep part of the mouth and the bracket, resulting in a sore feeling and a foreign body sensation. Therefore, the outer walls 212, 213, 312, and 313 of the brackets are mostly made of the first material 4. Compared with traditional rigid materials, the first material 4 is softer and more easily deformed, and can better fit the shape of the inner part of the mouth, thus providing a more comfortable wearing experience. In addition, the two ends 214, 215, 314, and 315 of the brackets also adopt the softer first material 4 to ensure the comfort of the mandibular joint and / or the deep part of the mouth. This design helps to improve the use comfort of the mandibular advancement device 1, reduce the discomfort of the user, improve the user experience of the user, and thus better improve the treatment effect.

[0116] 3) The mandibular advancement device 1 usually needs to be worn for a long time during sleep. Prolonged wearing and occlusion may cause soreness in the user's oral cavity or teeth. In addition, when wearing the mandibular advancement device 1, the lower tray assembly 3 moves forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the forward movement, the lower dentition is subjected to the traction force of forward movement, and the lower tray assembly 3 is subjected to the reaction force of the lower dentition to restore its shape; the upper dentition is subjected to the traction force of backward movement, and the upper tray assembly 2 is subjected to the reaction force of the upper dentition to restore its shape. Therefore, the larger stress-bearing surface of the lower tray assembly 3 faces the lingual side, and the larger stress-bearing surface of the upper tray assembly 2 faces the labial side. The present utility model provides an improved bracket design. The outer walls 212, 213, 312, 313 of the bracket are made of different materials for different stress directions, and most of the parts that are easily in contact with the oral soft tissues are made of the relatively soft first material 4. Compared with the traditional integral rigid material, this design can provide a more comfortable stress-bearing surface, reduce the discomfort of the oral cavity and teeth, and thus improve the user experience of the user.

[0117] 4) The mandibular advancement devices on the existing market still have the problem of being prone to falling off. Feedback from a large number of users shows that during sleep, the mandibular advancement device often separates from the oral cavity, resulting in the device falling off. Through test analysis, it is found that this falling-off problem is mainly due to the fact that the lower tray assembly needs to move forward relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep, and these situations may all cause the mandibular advancement device to be prone to falling off. In addition, most of the outer walls of the brackets on the market are made of rigid materials, and the exposed rigid materials are relatively easy to slide after contacting the oral cavity, further increasing the possibility of the mandibular advancement device falling off. To solve this problem, the present utility model provides an improved bracket design, and its outer walls 212, 213, 312, 313 include the relatively soft first material 4. The friction coefficient of the first material 4 is larger than that of the traditional rigid material, thereby increasing the friction force with the oral cavity. By increasing the friction force, the mandibular advancement device 1 can be more firmly fixed in the oral cavity, reducing the possibility of falling off and improving the stability and sustainability of the device during sleep.

[0118] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0119] The above-described embodiments merely represent several implementation manners of the present utility model. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the utility model patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present utility model, several modifications and improvements can still be made, and these all fall within the protection scope of the present utility model. Therefore, the protection scope of the present utility model patent shall be subject to the appended claims.

Claims

1. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, characterized in that, Comprising: An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper shapeable component; A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower shapeable component; Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper shapeable component and the lower shapeable component; The upper shapeable component and the lower shapeable component are configured to at least partially conform to the teeth and / or gums; The upper bracket and the lower bracket have at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material; The upper bracket and the lower bracket have a bottom wall; Wherein, the bottom wall of the upper bracket has a first end and a second end, and at least a part between the first end and the second end forms an approximate arc; The bottom wall of the lower bracket has a third end and a fourth end, and at least a part between the third end and the fourth end forms an approximate arc.

2. The mandibular advancement device according to claim 1, wherein The shape of the upper tray assembly is approximately arc-shaped, U-shaped or arched.

3. The mandibular advancement device according to claim 1, wherein, The shape of the lower tray assembly is approximately arc-shaped, U-shaped or arched.

4. The mandibular advancement device according to claim 1, wherein The first end, the second end, the third end and the fourth end include the first material.

5. The mandibular advancement device according to claim 1, wherein The hardness of the second material is higher than that of the first material.

6. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, characterized in that, Comprising: An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper shapeable component; A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower shapeable component; Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper shapeable component and the lower shapeable component; The upper bracket and the lower bracket have at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material; The upper bracket and the lower bracket have an outer wall; Wherein, at least a part of the outer wall includes the first material.

7. The mandibular advancement device according to claim 6, wherein The outer wall only includes the first material.

8. The mandibular advancement device according to claim 6, characterized in that, In the part of the outer wall in contact with the oral cavity, the area of the first material is larger than the area of the second material.

9. The mandibular advancement device according to claim 6, wherein The first material includes silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA.

10. The mandibular advancement device according to claim 6, characterized in that, The second material includes PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nitinol alloy, aluminum alloy.

11. The mandibular advancement device according to claim 6, wherein The outer wall forms an angle of 20 - 150° with the horizontal plane.

12. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, characterized in that, Comprising: An upper tray assembly configured to be adjacent to a part of the user's upper dentition, including an upper bracket and an upper shapeable component; A lower tray assembly configured to be adjacent to a part of the user's lower dentition, including a lower bracket and a lower shapeable component; Wherein, the upper bracket and the lower bracket are respectively configured to engage and support the upper shapeable component and the lower shapeable component; The upper bracket and the lower bracket have at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material; The upper bracket and the lower bracket have a bottom wall; Wherein, at least a part of the bottom wall includes the second material.

13. The mandibular advancement device according to claim 12, wherein, The bottom wall only includes the second material.

14. The mandibular advancement device according to claim 12, wherein The thickness of the second material in the bottom wall is at least 0.3 mm.

15. The mandibular advancement device according to claim 12, wherein, The projected area of the bottom wall on the horizontal plane is at least 9 cm 2 .

16. The mandibular advancement device according to claim 12, wherein The first material and the second material adopt fixing methods such as crimping, overmolding, snap fitting, bonding, hot melting, screwing, hooking.

17. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, characterized in that, Comprising: An upper tray assembly configured to be adjacent to a portion of a user's upper dentition, including an upper bracket and an upper moldable member; A lower tray assembly configured to be adjacent to a portion of a user's lower dentition, including a lower bracket and a lower moldable member; Wherein the upper bracket and the lower bracket are respectively configured to engage and support the upper moldable member and the lower moldable member; The upper bracket and the lower bracket are made of at least two materials with different hardnesses, and the hardness of the first material is lower than that of the second material; The upper bracket and the lower bracket have a bottom wall and an outer wall; The upper bracket and the lower bracket have one or more of the following characteristics: The volume ratio range of the first material and the second material is 0.05 - 20; The thickness range of at least a part of the outer wall is 0.3 - 6 mm; The thickness range of at least a part of the bottom wall is 0.3 - 6 mm.

18. The mandibular advancement device according to claim 17, characterized in that, The height in the middle of the outer wall is greater than the height at both ends of the outer wall.

19. The mandibular advancement device according to claim 17, wherein, The width in the middle of the outer wall is smaller than the width at both ends of the outer wall.

20. The mandibular advancement device according to claim 17, wherein, The upper bracket includes a first outer wall and a second outer wall, and the lower bracket includes a third outer wall and a fourth outer wall.

21. The mandibular advancement device according to claim 20, wherein, The second outer wall only includes the first material, and the first outer wall includes the second material.

22. The mandibular advancement device according to claim 20, wherein, The third outer wall only includes the first material, and the fourth outer wall includes the second material.

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