Lower jaw advancing device

Abstract

A mandibular advancement device includes an upper tray assembly including an upper bracket and an upper moldable member and a lower tray assembly including a lower bracket and a lower moldable member. 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 present invention relates to one or more of the treatment and amelioration of a respiratory-related disorder, providing a mandibular advancement device. BACKGROUND

[0002] Obstructive sleep apnea syndrome (OSAS) is a sleep apnea syndrome caused by obstructive lesions of the upper airway, defined as at least 30 apneas in 7 hours of nighttime sleep in adults, and each apnea time is at least 10 seconds or more; or the average number of apneas per hour is greater than 5. OSAS is characterized by loud snoring, shortness of breath, and alternating apnea of 10 seconds or more during sleep. When apnea occurs, the user will feel suffocated, and sometimes will suddenly wake up and fall asleep again after breathing recovers. The quality of sleep is also severely affected, and patients often feel tired and sleepy during the day, and long-term patients may have anxiety, depression, and other symptoms. Repeated hypoxia during sleep damages various organs and organs, and gradually develops to cause complications of the cardiovascular system, respiratory system, nervous system, endocrine system, urinary system, etc. According to the severity, OSAS can be divided into three degrees of light, medium and heavy. The purpose of treating OSAS is mainly to increase the tension of the respiratory tract, so that the respiratory tract can realize normal gas exchange, and bring oxygen from the external environment into the body, and at the same time, carbon dioxide generated by metabolism is discharged from the body. The methods for treating OSAS are generally as follows: etiology treatment, good living habits, drug treatment, continuous positive airway pressure (CPAP), oral appliance (MAD) treatment, surgical treatment, and other instrument intervention treatment.

[0003] Among these methods, CPAP treatment is the preferred choice for most people. The CPAP machine provides a constant and stable air pressure to the airway through a hose, mask, etc., so that the airway does not collapse during the entire respiratory cycle due to the positive pressure state, thereby 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 hoses, masks and other components, which are tied to the user's nose, face or mouth, making it difficult for the user to fall asleep and affecting sleep. In addition, the CPAP machine is relatively large in size and difficult to carry, making it difficult for users to carry it for travel. In addition, the CPAP treatment uses many components, and the cleaning scheme is complex, but if not properly cleaned, it may cause other respiratory diseases caused by bacteria or fungi.

[0004] Surgical treatment of OSAS was also very popular. If the cause of obstruction is clear, the obstruction can be removed by surgery such as removal of nasal polyps, correction of nasal septum deviation, tonsillectomy, adenoidectomy, etc.; oral orthognathic surgery is one of the treatment methods for OSAS caused by jaw factors. Due to the forward movement of the maxilla and mandible, the postoperative upper airway volume and the minimum cross-sectional area of the upper airway are significantly increased compared with the preoperative parameters, 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 results.

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

[0006] MAD treatment is to indirectly expand the upper airway by forward movement of the mandible to achieve therapeutic effect. MAD treatment can be divided into three categories according to the action site: soft palate action device (SPL), tongue retractor (TRD) and mandibular advancement device. The soft palate action device is fixed on the maxillary teeth and extends backward, directly acting on the soft palate and uvula, reducing their prolapse, reducing the contact between the long soft palate and uvula and the tongue root and the posterior wall of the pharynx, preventing pharyngeal stenosis or obstruction; at the same time, it can reduce the vibration of the soft palate and reduce snoring. However, the soft palate is easily touched and can cause nausea, so long-term training is needed to tolerate it, so it is rarely used. The tongue retractor is a ball-shaped object in front of the device that generates negative pressure to attract the tongue forward, preventing the tongue from falling backward, thereby expanding the airway behind the tongue and the soft palate. However, the comfort and fixation of the tongue retractor are poor, and the user's tolerance is poor, so it is also rarely used. The mandibular advancement device increases the oral pharyngeal cavity by keeping the mandible in a forward position, and indirectly moves the tongue forward, widening the airway behind the tongue, and reducing the backward pressure of the tongue on the soft palate, which also widens the airway behind the soft palate. The most common is the adjustable mandibular advancement device, which can increase the distance of mandibular advancement to expand the airway if the treatment effect is not good, and can reduce the amplitude of forward movement if discomfort occurs during treatment. This adjustable mandibular advancement device can improve the user's tolerance and achieve effective treatment.

[0007] However, there are many challenges in the design of mandibular advancement devices, 1) stability: during sleep, the user's movement or the unconscious opening and closing of the mouth can cause the mandibular advancement device to fall off, thereby affecting the sustainability of treatment; 2) applicability: due to the different shapes and sizes of everyone's mouth and teeth, as well as the high cost of customizing the mandibular advancement device, designing a mandibular advancement device suitable for most people faces great challenges; 3) comfort: when biting the mandibular advancement device, the inside of the cheek and the tongue are easily scratched by the mandibular advancement device, causing injury, and long-term wear of the mandibular advancement device can cause tooth discomfort problems due to prolonged biting time.

[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 needed. 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 morphology. By comprehensively considering these factors, the therapeutic effect and use comfort of the mandibular advancement device can be improved, so as to better meet the needs of the user. SUMMARY

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

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

[0011] A lower tray assembly configured to be adjacent to a portion of the user's lower dentition, comprising a lower support and a lower moldable component;

[0012] Wherein the upper support and the lower support 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 fit the teeth and / or gums;

[0014] The upper support and the lower support are made of at least two materials with different hardness, the first material having a lower hardness than the second material;

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

[0016] Wherein the upper support bottom wall has a first end and a second end, and the first end and the second end at least partially form an approximate arc shape;

[0017] The lower support bottom wall has a third end and a fourth end, and the third end and the fourth end at least partially form an approximate arc shape.

[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 comprise the first material.

[0021] In one embodiment, the second material has a higher hardness than the first material.

[0022] The application 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 portion of the upper dentition of the user, comprising an upper support and an upper shapeable component;

[0024] a lower tray assembly configured to be adjacent to a portion of the lower dentition of the user, comprising a lower support and a lower shapeable component;

[0025] wherein the upper support and the lower support are configured to engage and support the upper shapeable component and the lower shapeable component, respectively;

[0026] the upper support and the lower support comprise at least two materials with different hardness, a first material having a lower hardness than a second material;

[0027] the upper support and the lower support have an outer wall;

[0028] wherein the outer wall comprises at least partially the first material.

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

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

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

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

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

[0034] The application 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 portion of the upper dentition of the user, comprising an upper support and an upper shapeable component;

[0036] a lower tray assembly configured to be adjacent to a portion of the lower dentition of the user, comprising a lower support and a lower shapeable component;

[0037] wherein the upper support and the lower support are configured to engage and support the upper shapeable component and the lower shapeable component, respectively;

[0038] The upper and lower braces have at least two materials with different hardness, the first material has lower hardness than the second material;

[0039] The upper and lower braces have a bottom wall;

[0040] The bottom wall at least partially 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 0.3mm.

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

[0044] In one embodiment, the first material and the second material are fixed by crimping, over-molding, buckling, adhesion, hot melting, screwing, hooking.

[0045] The present application 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 portion of the upper dentition of the user, comprising an upper brace and an upper shapeable component;

[0047] A lower tray assembly configured to be adjacent to a portion of the lower dentition of the user, comprising a lower brace and a lower shapeable component;

[0048] The upper and lower braces are respectively configured to engage and support the upper and lower shapeable components;

[0049] The upper and lower braces have at least two materials with different hardness, the first material has lower hardness than the second material;

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

[0051] The upper and lower braces have one or more of the following properties:

[0052] The volume ratio of the first material to the second material ranges from 0.05 to 20;

[0053] The outer wall has a thickness ranging from 0.3 to 6mm at least partially;

[0054] The bottom wall has a thickness ranging from 0.3 to 6mm at least partially.

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

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

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

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

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

[0060] The mandibular advancement device of the present application has at least the following advantages:

[0061] 1) The supports of the existing mandibular advancement devices on the market are usually made of only one material. The exposed rigid parts of the supports made of only rigid materials are easy to scratch the inside of the mouth during wearing, causing the soft tissues or tongue inside the mouth to be stimulated or even injured. Secondly, if the entire mandibular advancement device is made of only a shapeable material or other relatively soft material, it will result in insufficient support during occlusion. In addition, the lower tray assembly needs to be advanced relative to the upper tray assembly, and the two need to be fixed to each other. The relatively soft material is easy to deform, which may cause the advancement distance to change, both causing the upper and lower tray assemblies to be easily separated and affecting the treatment effect. To solve this problem, the present application adopts an innovative design: the support has at least two materials with different hardness. Among them, the outer wall of the support is mainly composed of a first material, which is relatively soft and helps to reduce the scratching of the inside of the mouth during wearing. The bottom wall of the support is at least partially made of a second material with higher hardness, which provides the support force required during occlusion and the stability of fixing the support. In addition, the outer wall of the support forms a certain angle with the horizontal plane, which can adapt to the natural angle of the anterior teeth tilting to the labial side, and is more fitted to the shape of the teeth. Through this design, both the support force during occlusion and the stable connection of the upper and lower tray assemblies are ensured, reducing the possibility of device falling off, thereby ensuring that the mandibular advancement device has good effect during treatment.

[0062] 2) When the user uses the mandibular advancement device, the lower tray assembly is advanced relative to the upper tray assembly to achieve the effect of mandibular advancement. However, the advancement can cause the inside of the mouth to be crowded, especially when the advancement distance is large, which can cause the deep part of the mouth and the bracket to contact, causing aching and foreign body sensation. Therefore, the outer wall of the bracket is mostly made of a first material. Compared with traditional rigid materials, the first material is relatively soft and more easily deformed, which can better fit the shape of the inside of the mouth, thereby providing a more comfortable wearing experience. In addition, the two ends of the bracket also use a relatively soft first material to ensure the comfort of the mandibular joint and / or the deep part of the mouth. This design helps to improve the comfort of the mandibular advancement device and reduce the discomfort of the user, thereby improving the user experience of the user and better improving the treatment effect.

[0063] 3) The mandibular advancement device usually needs to be worn for a long time during sleep, and long-term wearing and biting can cause the user's mouth or teeth to feel aching. In addition, when wearing the mandibular advancement device, the lower tray assembly is advanced relative to the upper tray assembly to achieve the effect of mandibular advancement. During the advancement, the lower dentition is subjected to the traction force of the advancement, and the lower tray assembly is subjected to the reaction force of the lower dentition restoring the shape; the upper dentition is subjected to the traction force of the advancement, and the upper tray assembly is subjected to the reaction force of the upper dentition restoring the shape. Therefore, the larger stress surface of the lower tray assembly faces the tongue side, and the larger stress surface of the upper tray assembly faces the lip side. The present application provides an improved bracket design, in which the outer wall of the bracket is made of different materials according to different stress directions, and the part that is easy to contact the soft tissue of the mouth is mostly made of a relatively soft first material. Compared with the traditional rigid material of the integrated type, this design can provide a more comfortable stress surface, reduce the discomfort of the mouth and teeth, and thereby improve the user experience of the user.

[0064] 4) The mandibular advancement device on the market still has the problem of easy falling off, and a large number of users feedback that during sleep, the mandibular advancement device is often separated from the mouth, causing the device to fall off. After testing and analysis, it is found that this falling off problem is mainly due to the need for the lower tray assembly to be advanced relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep, which can cause the mandibular advancement device to easily fall off. In addition, the outer wall of the bracket on the market is mostly made of rigid material, and the exposed rigid material is more likely to slip after contacting the mouth, further increasing the possibility of the mandibular advancement device falling off. To solve this problem, the present application provides an improved bracket design, in which the outer wall includes a relatively soft first material. The friction coefficient of the first material is larger than that of the traditional rigid material, thereby increasing the friction force with the mouth. By increasing the friction force, the mandibular advancement device can be more firmly fixed in the mouth, reducing the possibility of falling off and improving the stability and sustainability of the device during sleep. BRIEF DESCRIPTION OF DRAWINGS

[0065] Figure 1 Structure diagram of the mandibular advancement device in one embodiment of the present application;

[0066] Figure 2 Structure exploded diagram of the mandibular advancement device in multiple embodiments of the present application;

[0067] Figure 3 Schematic diagram of horizontal plane, sagittal plane and coronal plane in multiple embodiments of the present application;

[0068] Figure 4 Top view of the upper support and the lower support separated in multiple embodiments of the present application;

[0069] Figure 5 Sectional view of the upper support in one embodiment of the present application in A-A direction; Figure 4

[0070] Sectional view of the upper support in one embodiment of the present application in B-B direction; Figure 6

[0071] Rear view of the upper support and the lower support combined in multiple embodiments of the present application; Figure 7 Figure 6 Sectional view of the support in one embodiment of the present application in D-D direction;

[0072] Figure 8 Figure 4 Sectional view of the upper support in one embodiment of the present application in B-B direction;

[0073] Figure 9 Sectional view of the support in the first embodiment of the present application;

[0074] Figure 10 Sectional view of the upper support in the first embodiment of the present application in A-A direction and C-C direction; Figure 4

[0075] Sectional view of the support in the first embodiment of the present application; Figure 11

[0076] Sectional view of the support in the second embodiment of the present application; Figure 12

[0077] Sectional view of the support in the second embodiment of the present application. Figure 13 DETAILED DESCRIPTION

[0078] ​​​In order to make the above objectives, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the drawings. In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application 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 spirit of the present application, so the present application is not limited to the specific embodiments disclosed below.

[0079] The present application relates to a mandibular advancement device, aiming at the limitation that most of the mandibular advancement device supports on the market are made of only one kind of material. To solve this problem, the present application adopts an innovative design-the support of the mandibular advancement device is made of two kinds of materials with different hardness. Through this design, the comfort and safety of the mandibular advancement device can be improved, thereby improving the user's experience and enhancing the treatment effect.

[0080] The present application provides a mandibular advancement device 1 for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to part of the upper dentition of the user, comprising an upper support 21 and an upper shapeable component 22, and the main function is to support the teeth of the upper jaw. The lower tray assembly 3 is configured to be adjacent to part of the lower dentition of the user, comprising a lower support 31 and a lower shapeable component 32, and the main function is to support the teeth of the lower jaw. Among them, the shape of the upper tray assembly 2 and the lower tray assembly 3 is approximately arc-shaped, U-shaped or arched, which conforms 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, which achieves the effect of treating OSAS by supporting the upper and lower jaw dentition and adjusting the front and rear distance, as well as exerting slight pressure on the teeth.

[0081] The upper shapeable component 22 and the lower shapeable component 32 are configured to at least partially fit the teeth and / or gums. The upper shapeable component 22 and the lower shapeable component 32 are generally arc-shaped, U-shaped or arched, similar to the shape of the dental arch, so as to ensure that the upper shapeable component 22 and the lower shapeable component 32 are in full contact with the teeth and gums. Part of the upper shapeable component 22 and the lower shapeable component 32 can have a convex or concave design to adapt to the different size requirements of the teeth. The upper shapeable component 22 and the lower shapeable component 32 are usually made of elastic materials such as silicone rubber, PU, PVA, EVA, etc. The material is required to have good biocompatibility and be soft and comfortable, without causing damage to the oral cavity, and is suitable for long-term wear in the oral cavity.

[0082] There are several different forms of moldable components on the market, commonly made in hospitals according to the teeth impressions of users, so that the moldable components can be precisely manufactured to better fit the teeth of the users, thereby ensuring better comfort and optimal treatment effect. But the customized moldable components require professional technology and equipment, which are relatively high in cost and long in duration, and if the moldable components are completed, it may be difficult to make substantial adjustments or changes, which requires re-manufacturing or processing. Therefore, a hot-melt moldable component is also very popular on the market, which has a relatively simple manufacturing process, only needs to heat and soften the material, bite and shape the required shape, and can be re-heated to adjust the shape in a small range after shaping, which not only speeds up the manufacturing process, but also reduces the cost. Because of the simple manufacturing process and the absence of professional equipment, the accuracy and adaptability of the hot-melt moldable component may be low, and there are limitations in the selection of materials, which requires the use of special hot-melt materials, but these materials may have limitations in hardness, comfort, etc. The upper moldable component 22 and the lower moldable component 32 provided in the present application include but are not limited to customized moldable components and hot-melt moldable components.

[0083] In particular, please refer to Figures 1 to 4 The upper support 21 and the lower support 31 are respectively configured to engage and support the upper moldable component 22 and the lower moldable component 32, and can provide stable support force in the oral cavity of the user. They can also have an adjustment function, allowing adjustment according to the needs of the user. The shape of the upper support 21 and the lower support 31 is usually similar to that of the upper moldable component 22 and the lower moldable component 32, and is also approximately arc-shaped, U-shaped or arched, to ensure that it fits the shape of the teeth inside the oral cavity.

[0084] The upper support 21 and the lower support 31 are made of at least two materials with different hardness, the first material 4 has lower hardness than 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, which can be in contact with the inside of the oral cavity without causing allergies or other adverse reactions, and the soft material is more comfortable than traditional rigid materials, more suitable for long-term wear and bite, which helps to reduce the discomfort and oral irritation of the user. Although the first material 4 is relatively soft, it also has a certain wear resistance, which can withstand the tension and friction force in the oral cavity during wearing, thereby improving the service life of the overall component. The second material 5 has higher hardness than the first material 4, and usually has strong hardness, which can withstand greater pressure to ensure that the upper support 21 and the lower support 31 are not easily deformed or damaged during wearing and biting, and maintain the structural stability of the support. 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 shown in Figure 5 , the first material 4 and the second material 5 on the upper support 21 and the lower support 31 are usually fixed in a non-detachable manner, which can be crimping (applying pressure to tightly combine the two), overmolding, buckling (constructing buckles on the first material 4 and the second material 5 respectively for engagement), adhesion (such as adhesive), hot melting (heating the first material 4 to melt and then cooling and fixing on the second material 5) or using additional fixing accessories such as screws, hooks, etc. The connection method can adopt one form, or even two or more forms can be combined to achieve the function of connecting and / or fixing the first material 4 and the second material 5. The selection of the appropriate connection method depends on the specific design requirements, material properties and use environment to ensure that the connection is firm, reliable, durable, and needs to be installed conveniently when production is required, and the user is convenient to adjust the operation. 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 the materials from falling off or loosening, and secondly, it can also prevent external substances from entering or remaining in the gap between the materials. Such sealing can effectively protect the interior of the material from residual bacteria or cleaning residues, and also prolong the service life.

[0086] The upper support 21 and the lower support 31 include a bottom wall 211, 311. As shown in Figure 6 , Figure 7 , the bottom wall 211, 311 is usually horizontal, the top of the bottom wall 211, 311 is attached to the upper moldable part 22 and the lower moldable part 32, and the bottom is formed with a passage with the bottom of the other bottom wall 211, 311. When the user wears the mandibular advancement device 1, the device is not completely closed, and the airflow from the outside can enter the user's oral cavity through the passage, without limiting the free flow of airflow in the user's oral cavity. At the same time, it also meets the use needs of users who are used to breathing through the mouth during sleep, avoiding the risk of suffocation. If the upper moldable part 22 and the lower moldable part 32 are heat-meltable, they need to be shaped by biting the upper and lower tray assemblies 2, 3, and if there is not enough vertical support force, it may cause difficulty or even failure in the shaping process. Secondly, the lower tray assembly 3 needs to be moved forward relative to the upper tray assembly 2, and the upper support 21 and the lower support 31 need to be fixed to each other. If a softer material is used, the softer material is prone to deformation, causing the forward movement distance to change, which will not only affect the treatment effect, but also cause the upper support 21 and the lower support 31 to easily separate. Therefore, an improved upper support 21 and lower support 31 are provided in the present application, wherein the bottom wall 211, 311 is at least partially composed of the second material 5, which provides sufficient vertical support force for the upper moldable part 22 and the lower moldable part 32. The area of the bottom wall 211, 311 on the horizontal plane is at least 9 cm 2and at least part of the thickness range is 0.3-6mm, i.e. Figure 7 d1 shown in the formula (1). The thickness of the second material 5 contained in the bottom wall 211, 311 is at least 0.3mm, i.e. Figure 7 d2 shown in the formula (2). The total weight of the upper bracket 21 and the lower bracket 31 is 3-50g, and the volume ratio 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 thickness of the second material 5 contained in the bracket bottom wall 211, 311 is 1-2mm. Through this design, the support force and rigidity required by the mandibular advancement device 1 can be ensured, and the upper bracket 21 and the lower bracket 31 are not too thick and heavy, thereby reducing the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

[0087] As shown in Figure 4 , Figure 8 , the upper bracket bottom wall 211 has a first end 214 and a second end 215, and at least part of the first end 214 and the second end 215 forms an approximate arc shape, a U shape or an arch shape; the lower bracket bottom wall 311 has a third end 314 and a fourth end 315, and at least part of the third end 314 and the fourth end 315 forms an approximate arc shape, a U shape or an arch shape. When the user uses the mandibular advancement device 1, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. However, the advancement may cause the oral cavity to be crowded, especially when the advancement distance is large, which may cause the deep part of the oral cavity to contact the upper bracket 21 and the lower bracket 31, causing aching and foreign body sensation. Therefore, the two ends 214, 215, 314, 315 of the bracket are made of a 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 comfort of the mandibular advancement device 1 and reduce the discomfort of the user, thereby improving the user experience of the user and better improving the treatment effect.

[0088] The upper bracket 21 and the lower bracket 31 comprise outer walls 212, 213, 312, 313. As shown in Figures 6 to 8 , the outer walls 212, 213, 312, 313 of the bracket are at least partially made of a relatively soft first material 4, and the area of the first material 4 is greater than that of the second material 5 in the part of the outer walls 212, 213, 312, 313 that contacts the oral cavity. Compared with traditional rigid materials, this first material 4 is more deformable and can better fit the shape of the inside of the oral cavity, thereby providing a more comfortable wearing experience.

[0089] When the mandibular advancement device 1 is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the advancement, the lower dentition is subjected to a forward traction force, and the lower tray assembly 3 is subjected to a counterforce to restore the shape of the lower dentition. The upper dentition is subjected to a backward traction force, and the upper tray assembly 2 is subjected to a counterforce to restore the shape of the upper dentition. 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. Since the displacement of the upper tray assembly 2 relative to the original position of the teeth is small, the counterforce acting on the upper tray assembly 2 is smaller than the counterforce acting on the lower tray assembly 3. The mandibular advancement devices on the market still have the problem of easy detachment. A large number of users have feedback that the mandibular advancement device often separates from the oral cavity during sleep, resulting in detachment of the device. Through testing and analysis, it is found that this detachment problem is mainly due to the need for the lower tray assembly to be advanced relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep. The lack of an outer wall in the support results in insufficient support force, which may cause the mandibular advancement device to easily detach. In addition, the outer wall of the support on the market is mostly made of rigid material. The rigid material exposed to the outside is more likely to slide after contacting the oral cavity, further increasing the possibility of detachment of the mandibular advancement device.

[0090] To solve these problems, the upper support 21 and the lower support 31 in the present application have outer walls 212, 213, 312, 313, which provide sufficient support force for the mandibular advancement device 1. In addition, the part of the outer walls 212, 213, 312, 313 that contacts the oral cavity is mostly made of a first material 4. The friction coefficient of the first material 4 is larger than that of traditional rigid materials, 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 detachment and improving the stability and sustainability of the device during sleep. This design helps to improve the comfort of use of the mandibular advancement device 1 and reduce the discomfort of the user, thereby improving the user experience of the user and better improving the treatment effect.

[0091] The following describes several structures of the mandibular advancement device 1 of the present application in conjunction with specific examples.

[0092] Example 1

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

[0094] Specifically, as shown in FIG. 1, the mandibular advancement device 1 includes an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to part of the upper dentition of the user and includes an upper support 21 and an upper shapeable component 22. The lower tray assembly 3 is configured to be adjacent to part of the lower dentition of the user and includes a lower support 31 and a lower shapeable component 32. Figure 2As shown, the upper and lower plastic parts 22 and 32 are configured to at least partially fit the teeth and / or gums. The upper and lower supports 21 and 31 are configured to engage and support the upper and lower plastic parts 22 and 32, respectively. The upper and lower supports 21 and 31 are made of at least two materials with different hardness, the first material 4 having a lower hardness than the second material 5.

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

[0096] In the present embodiment, the outer walls 212, 213, 312, 313 of the supports are connected to the bottom walls 211, 311, as shown, Figure 9 The upper and lower plastic parts 22 and 32 are contacted by 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, respectively. Each tooth has a certain angle difference, not necessarily perpendicular to the horizontal plane. For example, the front teeth (central incisors and lateral incisors) are usually inclined to the labial side with respect to the horizontal vertical plane, and the inclination angle is about 10-25°; the inclination angle of the canine teeth (labial direction) is usually between 5-15°; and the inclination angle of the molar teeth (labial direction) is usually between 0-5°. The front teeth and canine teeth have a larger angle with respect to the horizontal vertical plane, and the molar teeth have a smaller angle with respect to the horizontal vertical plane, which results in different support forces required by different teeth during occlusion. Therefore, the outer walls 212, 213, 312, 313 form an included angle of 20°-150° with the horizontal plane (towards the direction away from the bottom wall 211, 311), i.e. Figure 9 the angle α in the formula, wherein it is preferred that the included angle of the outer walls 212, 213, 312, 313 with the horizontal plane is 45-90°.

[0097] The teeth are located in different positions in the oral cavity, and the height and width of the outer walls 212, 213, 312, 313 are adjusted accordingly considering the size difference of different teeth. The central incisor part is usually narrow and long, suitable for cutting and tearing food, and the molar part is usually wide and thick, more suitable for chewing and grinding food. Therefore, as shown, Figure 10 ​​As shown, the outer walls 212, 213, 312, 313 are generally higher in the middle (with respect to the position of the tangent with the sagittal plane) and narrower in the front-back direction (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), and lower and wider in the two ends, that is, the height of the middle of the outer walls 212, 213, 312, 313 is greater than the height of the two ends Figure 10 , and the width of the middle is less than the width of the two ends Figure 10 . The middle part with higher and narrower portion can accommodate and fix the narrower and longer central incisors, and the molar part, although also longer, is wider and thicker, and is arranged to be lower and wider in the two ends, so as to avoid the molar being too wide to press the outer walls 212, 213, 312, 313.

[0098] When the mandibular advancement device 1 is worn, the lower tray assembly 3 is moved forward relative to the upper tray assembly 2 to achieve the effect of mandibular advancement, as shown in Figure 11 , during the forward movement, the lower dentition is subjected to a forward traction force, and the lower support 31 is subjected to a counterforce to restore the shape of the lower dentition, the upper dentition is subjected to a backward traction force, and the upper support 21 is subjected to a counterforce to restore the shape of the upper dentition. Therefore, the force receiving surface of the lower support 31 is located near the tongue side, and the force receiving surface of the upper support 21 is located near the lip side, and since the upper support 21 is offset from the original position of the teeth by a small amount, the counterforce acting on the upper support 21 is smaller than the counterforce acting on the lower support 31. Therefore, the larger force receiving surface of the upper support 21 is the first outer wall 212, and the larger force receiving surface of the lower support 31 is the fourth outer wall 313.

[0099] In this embodiment, the first material 4 has a lower hardness and is difficult to provide sufficient support force, and the portions of the support outer walls 212, 213, 312, 313 in contact with the oral cavity are mostly made 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 outer walls 212, 213, 312, 313 have a thickness range of 0.3-6mm, that is Figure 12 , w2, preferably the thickness of the outer walls 212, 213, 312, 313 is 1.2-2mm, 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 1mm, that is Figure 12 , w3. This design can not only ensure the required support force, but also not too thick and heavy, and retain the comfort of the first material 4 to the oral cavity, thereby avoiding increasing the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

[0100] The support forces required by the upper and lower tray assemblies 2, 3 are different due to the different properties of the materials. In other embodiments, the upper and lower support frames 21, 31 can be configured differently, e.g. the upper support frame 21 can not have the first and / or second outer walls 212, 213, and / or the lower support frame 31 can not have the third and / or fourth outer walls 312, 313.

[0101] Embodiment 2

[0102] The mandibular advancement device 1 of this embodiment comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a portion of the upper dentition of the user, and comprises an upper support frame 21 and an upper shapeable component 22. The lower tray assembly 3 is configured to be adjacent to a portion of the lower dentition of the user, and comprises a lower support frame 31 and a lower shapeable component 32.

[0103] In particular, as shown in Figure 2 , the upper and lower shapeable components 22, 32 are configured to at least partially conform to the teeth and / or gums. The upper and lower support frames 21, 31 are configured to engage and support the upper and lower shapeable components 22, 32, respectively. The upper and lower support frames 21, 31 comprise at least two materials with different hardnesses, a first material 4 with a lower hardness than a second material 5.

[0104] The upper and lower support frames 21, 31 comprise a bottom wall 211, 311 and an outer wall 212, 213, 312, 313. As shown in Figure 4 , Figure 6 , the upper support frame 21 comprises a bottom wall 211, a first outer wall 212 and a second outer wall 213, and the lower support frame 31 comprises a bottom wall 311, a third outer wall 312 and a fourth outer wall 313. The first and third outer walls 212, 312 are configured to face the labial side, and the second and fourth outer walls 213, 313 are configured to face the lingual side.

[0105] When the mandibular advancement device is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the advancement, the lower dentition is subjected to an advancement force, and the lower support frame 31 is subjected to a counterforce from the lower dentition as it resumes its shape. The upper dentition is subjected to a retraction force, and the upper support frame 21 is subjected to a counterforce from the upper dentition as it resumes its shape. Therefore, the force-bearing surface of the lower support frame 31 is located closer to the lingual side, and the force-bearing surface of the upper support frame 21 is located closer to the labial side. Furthermore, since the upper support frame 21 is displaced less relative to the original position of the teeth, the counterforce experienced by the upper support frame 21 is less than that experienced by the lower support frame 31. Therefore, the larger force-bearing surface of the upper support frame 21 is the first outer wall 212, and the larger force-bearing surface of the lower support frame 31 is the fourth outer wall 313.

[0106] In this embodiment, the first material 4 has a certain hardness and can provide some support force, but the larger force-bearing surfaces still require the second material 5 to provide more support force. As shown inFigure 12 As shown, the first outer wall 212 and the fourth outer wall 313 comprise the second material 5 and the first material 4, and the second outer wall 213 and the third outer wall 312 only comprise the first material 4. In the larger force receiving surface, the outer wall 212, 313 is jointly formed by the second material 5 and the first material 4 to provide sufficient support force; in the smaller force receiving surface, the first material 4 is sufficient to provide support force for the outer wall 213, 312. The thickness of the outer wall 212, 213, 312, 313 is at least partially in the range of 0.3-6mm, i.e. Figure 12 w2, preferably the thickness of the outer wall 212, 213, 312, 313 is in the range of 1.2-2mm, and the thickness of the second material 5 in the first outer wall 212 and the fourth outer wall 313 is 1mm, i.e. Figure 12 w3. This design can ensure the required support force without being too thick and heavy, and the comfort of the first material 4 to the oral cavity is retained, thereby avoiding increasing the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

[0107] Embodiment 3

[0108] The mandibular advancement device 1 of this embodiment comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to part of the upper dentition of the user, comprising an upper support 21 and an upper shapeable component 22. The lower tray assembly 3 is configured to be adjacent to part of the lower dentition of the user, comprising a lower support 31 and a lower shapeable component 32. Specifically, as shown in Figure 2 The upper shapeable component 22 and the lower shapeable component 32 are configured to at least partially fit the teeth and / or gums. The upper support 21 and the lower support 31 are configured to engage and support the upper shapeable component 22 and the lower shapeable component 32, respectively. The upper support 21 and the lower support 31 comprise at least two materials with different hardness, the hardness of the first material 4 being lower than that of the second material 5.

[0109] The upper support 21 and the lower support 31 comprise a bottom wall 211, 311 and an outer wall 212, 213, 312, 313. As shown in Figure 4 , Figure 6 The upper support 21 comprises a bottom wall 211, a first outer wall 212 and a second outer wall 213, and the lower support 31 comprises 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.

[0110] When the mandibular advancement device is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve the effect of mandibular advancement. During the advancement, the lower dentition is subjected to a forward traction, the lower support 31 is subjected to a counterforce for restoring the shape of the lower dentition, the upper dentition is subjected to a backward traction, and the upper support 21 is subjected to a counterforce for restoring the shape of the upper dentition. Therefore, the force receiving surface of the lower support 31 is located near the lingual side, and the force receiving surface of the upper support 21 is located near the labial side. Since the upper support 21 is less offset from the original position of the teeth, the counterforce acting on the upper support 21 is less than the counterforce acting on the lower support 31. Therefore, the larger force receiving surface of the upper support 21 is the first outer wall 212, and the larger force receiving surface of the lower support 31 is the fourth outer wall 313.

[0111] In the present embodiment, the first material 4 has a greater hardness and can provide sufficient support force. As 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. The outer walls 212, 213, 312, and 313 have a thickness of at least 0.3-6 mm, i.e., w2 in the formula (1), and preferably a thickness of 1.2-2 mm. This design can ensure the required support force without being too thick and heavy, and retains the comfort of the first material 4 to the oral cavity, thereby avoiding increasing the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity. Figure 13 Figure 13 In the present embodiment, the first material 4 has a greater hardness and can provide sufficient support force. As 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. The outer walls 212, 213, 312, and 313 have a thickness of at least 0.3-6 mm, i.e., w2 in the formula (1), and preferably a thickness of 1.2-2 mm. This design can ensure the required support force without being too thick and heavy, and retains the comfort of the first material 4 to 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 a mandibular advancement device 1 including all or part of the above technical features.

[0113] The mandibular advancement device 1 according to the present application has at least the following beneficial effects:

[0114] ​1) The brackets of the existing mandibular advancement devices on the market are usually made of only one kind of material. The exposed rigid parts of the brackets made of only rigid materials are easy to scratch the inside of the mouth during wearing, causing the soft tissues or tongue inside the mouth to be stimulated or even injured. Secondly, if the mandibular advancement device 1 as a whole is made of only a shapeable material or other softer material, it will cause insufficient support during occlusion. In addition, the lower tray assembly 3 needs to be moved forward relative to the upper tray assembly 2, and the two need to be fixed to each other. The softer material is easy to deform, which may cause the forward movement distance to change, both causing the upper and lower tray assemblies 2, 3 to be easily separated and affecting the treatment effect. To solve this problem, the present application adopts an innovative design: the upper bracket 21 and the lower bracket 31 have at least two materials with different hardness. Among them, the bracket outer walls 212, 213, 312, 313 are mainly composed of a first material 4, which is relatively soft, helping to reduce the scratching of the inside of the mouth during wearing. The bracket bottom walls 211, 311 are at least partially made of a second material 5 with higher hardness, which provides the support required during occlusion and the stability of fixing the upper bracket 21 and the lower bracket 31. In addition, the bracket outer walls 212, 213, 312, 313 form a certain angle with the horizontal plane, which can adapt to the natural angle of the front teeth tilting to the lip side, and fit the shape of the teeth more closely. Through this design, both the support during occlusion and the stable connection of the upper and lower tray assemblies 2, 3 are ensured, reducing the possibility of device falling off, thereby ensuring that the mandibular advancement device 1 has good effect during treatment.

[0115] 2) When the user uses the mandibular advancement device 1, the lower tray assembly 3 is moved forward relative to the upper tray assembly 1 to achieve the effect of mandibular advancement. However, the forward movement may cause the inside of the mouth to be crowded, especially when the forward movement distance is large, which may cause the deep part of the mouth to contact the bracket, causing aching and foreign body sensation. Therefore, the bracket outer walls 212, 213, 312, 313 are mostly made of a first material 4. Compared with traditional rigid materials, the first material 4 is relatively soft and more easily deformed, which can better fit the shape of the inside of the mouth, thereby providing a more comfortable wearing experience. In addition, the two ends 214, 215, 314, 315 of the bracket also adopt the first material 4 which is relatively soft to ensure the comfort of the mandibular joint and / or the deep part of the mouth. This design helps to improve the comfort of the mandibular advancement device 1 and reduce the discomfort of the user, improving the user experience of the user, thereby better improving the treatment effect.

[0116] 3) The mandibular advancement device 1 is usually required to be worn for a long time during sleep, and long-term wearing and biting can cause the user's mouth or teeth to feel sore. In addition, when wearing the mandibular advancement device 1, the lower tray assembly 3 is moved 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 counterforce to restore the shape of the lower dentition; the upper dentition is subjected to a backward traction force, and the upper tray assembly 2 is subjected to a counterforce to restore the shape of the upper dentition. Therefore, the larger force receiving surface of the lower tray assembly 3 faces the tongue side, and the larger force receiving surface of the upper tray assembly 2 faces the lip side. The present application provides an improved support design, in which the outer walls 212, 213, 312, 313 of the support are made of different materials according to different stress directions, and the parts that are easy to contact the soft tissue of the oral cavity are mostly made of a softer first material 4. Compared with the traditional integrated rigid material, this design can provide a more comfortable force receiving surface and reduce the discomfort of the oral cavity and teeth, thereby improving the user experience of the user.

[0117] 4) The mandibular advancement device on the market still has the problem of easy falling off, and a large number of users have feedback that the mandibular advancement device often separates from the oral cavity during sleep, resulting in device falling off. Through test analysis, it is found that this falling off problem is mainly due to the need for the lower tray assembly to move forward relative to the upper tray assembly, and the user may move or unconsciously open and close the mouth during sleep, which can cause the mandibular advancement device to easily fall off. In addition, the outer walls of the supports 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 application provides an improved support design, in which the outer walls 212, 213, 312, 313 include a softer 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 in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not contradict, they should be considered within the scope of the present application.

[0119] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are within the scope of protection of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising: an upper tray assembly configured to be adjacent to a portion of the upper dentition of a user, comprising an upper brace and an upper moldable component; a lower tray assembly configured to be adjacent to a portion of the lower dentition of a user, comprising a lower brace and a lower moldable component; wherein the upper brace and lower brace are configured to engage and support the upper moldable component and lower moldable component, respectively; the upper moldable component and lower moldable component are configured to at least partially conform to the teeth and / or gums; the upper brace and lower brace comprise at least two materials having different hardnesses, a first material having a lower hardness than a second material; the upper brace and lower brace comprise a bottom wall; wherein the upper brace bottom wall comprises a first end and a second end, the first end and the second end at least partially forming an approximate arc shape therebetween; the lower brace bottom wall comprises a third end and a fourth end, the third end and the fourth end at least partially forming an approximate arc shape therebetween.

2. The mandibular advancement device of claim 1, wherein, the upper tray assembly comprises an approximate arc shape, U-shape, or arch shape.

3. The mandibular advancement device of claim 1, wherein, the lower tray assembly comprises an approximate arc shape, U-shape, or arch shape.

4. The mandibular advancement device of claim 1, wherein, the first end, second end, third end, and fourth end comprise the first material.

5. The mandibular advancement device of claim 1, wherein, the second material has a higher hardness than the first material.

6. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising: an upper tray assembly configured to be adjacent to a portion of the upper dentition of a user, comprising an upper brace and an upper moldable component; a lower tray assembly configured to be adjacent to a portion of the lower dentition of a user, comprising a lower brace and a lower moldable component; wherein the upper brace and lower brace are configured to engage and support the upper moldable component and lower moldable component, respectively; the upper brace and lower brace comprise at least two materials having different hardnesses, a first material having a lower hardness than a second material; the upper brace and lower brace comprise an outer wall; wherein the outer wall comprises at least partially the first material.

7. The mandibular advancement device of claim 6, wherein, the outer wall comprises only the first material.

8. The mandibular advancement device of claim 6, wherein, the first material comprises a greater area than the second material in the portion of the outer wall that contacts the oral cavity.

9. The mandibular advancement device of claim 6, wherein, the first material comprises silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA.

10. The mandibular advancement device of claim 6, wherein, the second material comprises PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nickel-titanium alloy, aluminum alloy.

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

12. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising: an upper tray assembly configured to be adjacent to a portion of the upper dentition of a user, comprising an upper brace and an upper moldable component; a lower tray assembly configured to be adjacent to a portion of the lower dentition of a user, comprising a lower brace and a lower moldable component; wherein the upper brace and lower brace are configured to engage and support the upper moldable component and lower moldable component, respectively; the upper brace and lower brace comprise at least two materials having different hardnesses, a first material having a lower hardness than a second material; the upper brace and lower brace comprise a bottom wall; The bottom wall comprises at least partially the second material.

13. The mandibular advancement device of claim 12, wherein, The bottom wall comprises only the second material.

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

15. The mandibular advancement device of claim 12, wherein, The bottom wall has a projected area on a horizontal plane of at least 9 cm 2 .

16. The mandibular advancement device of claim 12, wherein, The first material and the second material are fixed by crimping, over-molding, snap, adhesive, hot melt, screw, hook.

17. A mandibular advancement device for preventing or reducing snoring and / or obstructive sleep apnea during sleep, comprising: an upper tray assembly configured to be adjacent to a portion of the upper dentition of the user, comprising an upper brace and an upper moldable component; a lower tray assembly configured to be adjacent to a portion of the lower dentition of the user, comprising a lower brace and a lower moldable component; wherein the upper brace and the lower brace are configured to engage and support the upper moldable component and the lower moldable component, respectively; the upper brace and the lower brace comprise at least two materials with different hardness, the first material has lower hardness than the second material; the upper brace and the lower brace have a bottom wall and an outer wall; the upper brace and the lower brace have one or more of the following properties: the volume ratio of the first material to the second material ranges from 0.05 to 20; the outer wall has a thickness ranging from 0.3mm to 6mm at least partially; the bottom wall has a thickness ranging from 0.3mm to 6mm at least partially.

18. The mandibular advancement device of claim 17, wherein, the height of the middle of the outer wall is greater than the height of the two ends of the outer wall.

19. The mandibular advancement device of claim 17, wherein, the width of the middle of the outer wall is less than the width of the two ends of the outer wall.

20. The mandibular advancement device of claim 17, wherein, the upper brace comprises a first outer wall and a second outer wall, and the lower brace comprises a third outer wall and a fourth outer wall.

21. The mandibular advancement device of claim 20, wherein, the second outer wall comprises only the first material, and the first outer wall comprises the second material.

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

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