Oral appliance

Abstract

The utility model relates to an oral appliance, and particularly discloses an oral appliance which is convenient for a user to use, reduces the use cost of the user and is comfortable to wear, and the oral appliance comprises an upper tray assembly and a lower tray assembly, wherein the upper tray assembly comprises an upper moldable part and an upper bracket, and the lower tray assembly comprises a lower moldable part and a lower bracket; the upper moldable part and the lower moldable part are made of materials with plasticity and can be deformed when heated, and the upper support and the lower support do not deform when heated to the temperature needed by deformation of the upper moldable part and the lower moldable part. The upper moldable part is configured to be detachably connected with the upper support, and the lower moldable part is configured to be detachably connected with the lower support.

Description

Technical Field

[0001] The utility model relates to an oral appliance, in particular to a device for preventing, reducing or eliminating snoring and / or obstructive sleep apnea. Background Art

[0002] Obstructive sleep apnea is a sleep-related breathing disorder caused by the relaxation of muscles in the tongue, soft palate and posterior wall of the oropharynx during sleep, usually resulting in the user's breathing stopping for 10 seconds or longer each time, and this situation occurring 5 - 30 times or more per hour. The persistence of this disorder will lead to excessive daytime sleepiness, snoring at night, headache in the morning for the user, and may cause complications such as cardiovascular diseases and brain damage.

[0003] There are currently many methods for preventing snoring and / or obstructive sleep apnea. One method is to increase the airflow in the throat passage by pushing the position of the mandible relative to the maxilla. Since the 19th century, it has been proven that pushing the mandible can increase the airflow in the throat passage, thereby reducing or eliminating the occurrence of snoring and / or obstructive sleep apnea.

[0004] The mandibular advancement device in an oral appliance is a device that can adjust the position of the user's mandible, aiming to help relieve or prevent the user's snoring and sleep apnea. Generally, the working principle of the mandibular advancement device is to position the mandible, that is, the lower jaw bone, in a position more forward than the neutral mandibular position, thereby increasing the airflow in the throat passage. Therefore, the oral appliance helps to reduce or eliminate snoring and / or obstructive sleep apnea.

[0005] Although the oral appliance helps to reduce or eliminate snoring and / or obstructive sleep apnea, the customization of such a device by dental care professionals requires additional work and the user needs to frequently visit the dental clinic for customization or adjustment, thus increasing the user's time and financial costs. In addition, if the user, especially an individual, completes the molding of the mandibular advancement device by themselves, problems such as poor comfort often occur. Summary of the Utility Model

[0006] Based on the above deficiencies, the utility model provides an oral appliance that is convenient for users to use, reduces the user's usage cost and is comfortable to wear.

[0007] An oral appliance, comprising:

[0008] An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity;

[0009] A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity;

[0010] The upper tray assembly includes an upper deformable component and an upper bracket;

[0011] The lower tray assembly includes a lower deformable component and a lower bracket;

[0012] Wherein, the upper deformable component and the lower deformable component are made of a deformable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper deformable component and the lower deformable component;

[0013] The upper deformable component is configured to be detachably connected to the upper bracket;

[0014] The lower deformable component is configured to be detachably connected to the lower bracket;

[0015] The upper deformable component and the lower deformable component have outer walls;

[0016] The upper bracket and the lower bracket have inner walls;

[0017] The outer walls of the upper deformable component and the lower deformable component are at least partially in contact with the inner walls of the upper bracket and the lower bracket respectively.

[0018] In one embodiment, the shape of the upper tray assembly is configured to conform to the arched structure of the user's maxillary dentition curve.

[0019] In one embodiment, the shape of the lower tray assembly is configured to conform to the arched structure of the user's mandibular dentition curve.

[0020] In one embodiment, at least part of the upper deformable component and the lower deformable component are made of a flexible thermoplastic material.

[0021] In one embodiment, at least part of the upper bracket and the lower bracket are made of a material with a higher stiffness than the upper deformable component and the lower deformable component.

[0022] The present utility model also discloses an oral appliance, including:

[0023] An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity;

[0024] A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity;

[0025] The upper tray assembly includes an upper deformable component and an upper bracket;

[0026] The lower tray assembly includes a lower deformable component and a lower bracket;

[0027] Among them, the upper deformable component and the lower deformable component are made of a deformable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper deformable component and the lower deformable component;

[0028] The upper deformable component is configured to be detachably connected to the upper bracket;

[0029] The lower deformable component is configured to be detachably connected to the lower bracket;

[0030] The projected area of the upper deformable component on the horizontal plane is larger than the projected area of the upper bracket on the horizontal plane;

[0031] The projected area of the lower deformable component on the horizontal plane is larger than the projected area of the lower bracket on the horizontal plane.

[0032] In one embodiment, the upper deformable component and the lower deformable component are made of a deformable material, and the temperature required for heating to deformation is less than 100 degrees Celsius.

[0033] In one embodiment, the upper bracket and the lower bracket are made of a material with high-temperature stability, and the temperature required for heating to deformation is greater than 100 degrees Celsius.

[0034] In one embodiment, the ratio of the sum of the projected areas of the upper deformable component and the lower deformable component on the horizontal plane to the sum of the projected areas of the upper bracket and the lower bracket on the horizontal plane is greater than 1.

[0035] In one embodiment, the lengths of the outwardly extending ends of the upper deformable component and the lower deformable component are both greater than the lengths of the outwardly extending ends of the upper bracket and the lower bracket.

[0036] The present utility model also discloses an oral appliance, including:

[0037] An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity;

[0038] A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity;

[0039] The upper tray assembly includes an upper deformable component and an upper bracket;

[0040] The lower tray assembly includes a lower deformable component and a lower bracket;

[0041] The upper tray assembly and / or the lower tray assembly has a connecting portion configured to connect the upper deformable component and the upper bracket and to connect the lower deformable component and the lower bracket respectively;

[0042] Among them, the upper shapeable component and the lower shapeable component are made of a shapeable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper shapeable component and the lower shapeable component;

[0043] The upper shapeable component is configured to be detachably connected to the upper bracket;

[0044] The lower shapeable component is configured to be detachably connected to the lower bracket.

[0045] In one embodiment, the upper bracket and the lower bracket are detachably connected to the upper shapeable component and the lower shapeable component respectively through additional external components.

[0046] In one embodiment, the connecting part includes protrusions, grooves and / or additional external components such as pins, screws, pins, magnets.

[0047] In one embodiment, the shape of the protrusion adopts at least one of a cylindrical shape, a square shape, a spherical shape, a T shape, and an L shape.

[0048] In one embodiment, the protrusions are located on the upper shapeable component and the lower shapeable component and respectively match the grooves on the upper bracket and the lower bracket.

[0049] In one embodiment, the grooves are located on the upper shapeable component and the lower shapeable component and respectively match the protrusions on the upper bracket and the lower bracket.

[0050] The present utility model also discloses an oral appliance, including:

[0051] An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity;

[0052] A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity;

[0053] The upper tray assembly includes an upper shapeable component and an upper bracket;

[0054] The lower tray assembly includes a lower shapeable component and a lower bracket;

[0055] Among them, the upper shapeable component and the lower shapeable component are made of a shapeable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper shapeable component and the lower shapeable component;

[0056] The upper shapeable component is configured to be detachably connected to the upper bracket;

[0057] The lower plastically deformable component is configured to be detachably connected to the lower bracket;

[0058] The upper bracket and / or the lower bracket has at least one groove.

[0059] In one embodiment, the grooves of the upper bracket and the lower bracket are configured to accommodate the materials overflowed by the upper plastically deformable component and the lower plastically deformable component during the hot melting process.

[0060] In one embodiment, the shapes of the upper plastically deformable component and the lower plastically deformable component adopt at least one of an oval arch, a conical arch and a square arch to conform to the dental arch curve of the user.

[0061] In one embodiment, both the upper bracket and the lower bracket have an inner wall and an outer wall, and the distance between the inner wall and the outer wall is at least partially 0.3 - 8 mm.

[0062] The oral appliance implementing the present utility model has at least the following beneficial effects:

[0063] 1) Since the plastically deformable component and the bracket are designed to be detachably connected, and the disassembly and installation processes are simple and easy, the user can quickly and conveniently replace the plastically deformable component without replacing the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only some components need to be replaced instead of the entire device, this design significantly reduces the waste of materials, helps to reduce resource consumption, and thus reflects significant environmental friendliness and climate friendliness. By reducing the generation of waste and reusing resources, the present utility model helps to reduce carbon emissions and environmental load.

[0064] 2) The plastically deformable component is made of a plastic material and can be deformed when heated. The user can put the heated plastically deformable component into the oral cavity and shape it by biting to fit the dental arch. If there are problems such as operation errors or improper biting during the biting process, since the plastically deformable component and the bracket are designed to be detachably connected, the user can replace the plastically deformable component again and bite again without replacing the entire device. This design not only significantly reduces the waste of resources and money, but also improves the adjustability of the device and the user experience.

[0065] 3) The shapeable component is made of a flexible thermoplastic material and is used to withstand the biting force of the user. Therefore, its lifespan is usually shorter than that of the bracket. When the shapeable component is damaged or needs to be replaced, since it is designed to be detachably connected to the bracket, only the shapeable component needs to be replaced, rather than the entire device. In addition, if the bracket needs to be replaced while the shapeable component can still be used, the shaped shapeable component can be installed on the new bracket without reshaping. This design not only saves time but also effectively reduces the waste of resources and money, significantly improving the economy and usage efficiency of the device. By reducing material consumption and extending the service life of each component, it helps to reduce carbon emissions and the environmental load.

[0066] 4) The bracket has a groove. This groove can not only fix the protrusion of the shapeable component therein but also accommodate the material that overflows during the hot melting process of the shapeable component. The overflowed material fills the groove after cooling, further enhancing the fixing effect between the bracket and the shapeable component. Through the design of the groove structure on the bracket, the present utility model realizes the double fixation of the shapeable component, improving the stability of the connection, simplifying the installation process, and ensuring the reliability of the device during use. In addition, the structure of the connection part between the bracket and the shapeable component is relatively simple, enabling the shapeable component to be easily removed from the bracket, thus realizing the detachable function of the device and facilitating maintenance and replacement.

[0067] 5) Compared with the bracket, the shapeable component is made of a flexible material, which can better adapt to the oral cavity morphology, reducing irritation and scratching of the oral soft tissues. At the same time, the horizontal plane projection area of the shapeable component is larger than that of the bracket, helping to reduce the contact pressure on the oral soft tissues and further reducing the risk of scratching. Considering the differences in the distance from the inner side of the lip to the retromolar area among different users, the oral appliance design of the present utility model allows the user to adjust the length by trimming to adapt to the distance from the inner side of the lip to the retromolar area. The soft shapeable component enables the user to easily perform trimming and independently adjust the device length according to personal needs, thus improving the comfort and personalized adaptability of use. It should be noted that since the horizontal plane projection area of the shapeable component is larger than that of the bracket, trimming will not affect the structure and function of the bracket, thus ensuring the stability and effectiveness of the oral appliance. Description of the Drawings

[0068] Figure 1 is the overall schematic diagram of the oral appliance in an embodiment of the present utility model;

[0069] Figure 2 is the exploded schematic diagram of the structure of the oral appliance in multiple embodiments of the present utility model;

[0070] Figure 3Top view of the shapeable component and the dental arch shape in multiple embodiments of the present utility model;

[0071] Figure 4 Schematic diagrams of the horizontal plane, sagittal plane, and coronal plane in multiple embodiments of the present utility model;

[0072] Figure 5 Top view of the upper tray assembly in multiple embodiments of the present utility model;

[0073] Figure 6 Cross-sectional schematic diagram of the connection part in one embodiment of the present utility model;

[0074] Figure 7 Structural schematic diagram of the lower tray assembly in one embodiment of the present utility model;

[0075] Figure 8 Exploded structural schematic diagram of the upper shapeable component and the upper bracket in the first embodiment of the present utility model;

[0076] Figure 9 Cross-sectional schematic diagram of the upper shapeable component and the upper bracket in the first embodiment of the present utility model;

[0077] Figure 10 Exploded structural schematic diagram of the upper shapeable component and the upper bracket in the second embodiment of the present utility model;

[0078] Figure 11 Exploded structural schematic diagram of the upper shapeable component and the upper bracket in the second embodiment of the present utility model;

[0079] Figure 12 Cross-sectional schematic diagram of the end part of the upper shapeable component and the upper bracket in the second embodiment of the present utility model;

[0080] Figure 13 Partial comparison schematic diagram before and after boiling and biting of the connection part between the upper shapeable component and the upper bracket in the third embodiment of the present utility model. Detailed implementation manners

[0081] To make the above objects, features, and advantages of the present utility model more obvious and understandable, the following will describe the detailed implementation manners of the present utility model in conjunction with the accompanying drawings. Many specific details are set forth in the following description in order to fully understand 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.

[0082] The present utility model relates to an oral appliance 1, and particularly to a device for preventing, reducing or eliminating snoring and / or obstructive sleep apnea. In some embodiments, such an appliance may also be used as a mouthguard for the maxillary dentition, the mandibular dentition, or both dentitions during exercise. In some embodiments, such an appliance may also be used as a bruxism device for the maxillary dentition, the mandibular dentition, or both dentitions.

[0083] The present utility model provides an oral appliance 1 that is convenient for users to use, reduces the usage cost of users, and is comfortable to wear.

[0084] Specifically, please refer to Figures 1 to 3 , the oral appliance 1 in the present utility model includes an upper tray assembly 2 and a lower tray assembly 3. Among them, the upper tray assembly 2 is configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity. The lower tray assembly 3 is configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity. Further, when the upper tray assembly 2 is positioned in the user's oral cavity, its position is below the user's maxillary dentition. When the lower tray assembly 3 is positioned in the user's oral cavity, its position is above the user's mandibular dentition. The dentition usually presents an arc-shaped structure that conforms to the natural tooth arrangement of the user. Specifically, both the maxillary dentition and the mandibular dentition form a generally symmetric and approximately arched curve. Therefore, the shapes of the upper tray assembly 2 and the lower tray assembly 3 are configured to conform to the arched structure of the user's dentition curve, so as to better fit the user's maxillary and mandibular teeth, thereby providing sufficient support and stability for the oral appliance 1.

[0085] The upper tray assembly 2 includes an upper moldable part 21 and an upper bracket 22, and the lower tray assembly 3 includes a lower moldable part 31 and a lower bracket 32. In the present utility model, the brackets 22, 32 include the upper bracket 22 and the lower bracket 32, and the moldable parts 21, 31 include the upper moldable part 21 and the lower moldable part 31. The materials of the upper tray assembly 2 and the lower tray assembly 3 have a wide range of choices, and plastic or polymer materials applicable to oral medical devices and capable of being molded can be used. These materials include, but are not limited to, polypropylene (PP), polycarbonate (PC), polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polyphenyl sulfone (PPSU), polyethylene (PE), high-density polyethylene (HDPE), low-density polyethylene (LDPE), ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane (TPU), styrene-ethylene-butene-styrene (SEBS), styrene-ethylene-styrene (SEPS), silicone rubber, etc. These materials have good biocompatibility, mechanical properties and processing properties, which are beneficial to the manufacture of the oral appliance 1. Each part of the upper tray assembly 2 and the lower tray assembly 3, such as the moldable parts 21, 31 and the brackets 22, 32, can be made of a single material or a combination of multiple materials. This design of combining multiple materials can make full use of the characteristics of different materials to meet various requirements during the use of the oral appliance 1. A multi-layer structure can also be adopted, and the materials of each layer can be the same or different. This design can achieve an optimized configuration of material properties. Polymer materials may contain various fillers, plasticizers, pigments and other additives to meet different performance requirements and manufacturing needs. For example, nano-scale fillers can be added to enhance the strength and hardness of the materials, or antibacterial agents can be added to improve the hygienic performance of the oral appliance. Applicable types of polymer materials include thermoplastics, thermosetting polymers, elastomers and thermoplastic elastomers. These materials may be copolymers, terpolymers, or mixtures of different types of polymers. For example, mixtures of thermoplastics with different molecular weights. These materials all have good processing properties and mechanical properties, which are beneficial to the manufacture of the oral appliance 1.

[0086] The upper tray assembly 2 and / or the lower tray assembly 3 further includes a fixing part 4 configured to connect and / or fix the upper tray assembly 2 and the lower tray assembly 3. When the user uses the oral appliance, the fixing part 4 fixes the user's mandible in a position in front of the user's maxilla to achieve the function of mandibular advancement.

[0087] The material selection of the fixing part 4 should take into account its need for a tight connection with the tray components 2 and 3 to ensure the stability and reliability of the oral appliance 1. The material of the fixing part 4 can be a moldable material or a polymer material that is the same as the upper tray component 2 and the lower tray component 3, or other materials suitable for oral medical devices and appliances such as metals. The fixing part 4 can be made of a single material or a combination of multiple materials.

[0088] The shapeable parts 21 and 31 are made of a shapeable material, preferably a thermoplastic material, so that the user can perform shaping by self-heating to complete the adaptive adjustment. The heating and shaping method used in the present utility model is "boiling and biting", which is a simple and easy method. The user only needs to put the oral appliance 1 into hot water for heating, and then gently bite the oral appliance 1 with the mouth to make it fit well with the user's teeth. The shapeable parts 21 and 31 can be deformed when heated, and the brackets 22 and 32 do not deform when heated to the temperature required for the deformation of the shapeable parts 21 and 31. Among them, the shapeable parts 21 and 31 are made of a shapeable material, and the temperature required for deformation is less than 100 degrees Celsius, and the brackets 22 and 32 are made of a material with high temperature stability, and the temperature required for deformation is greater than 100 degrees Celsius. This design ensures the stability and reliability of the oral appliance 1 during the shaping process, enabling the user to easily complete the adaptive adjustment and obtain a better user experience. If the brackets 22 and 32 also use thermoplastic materials, their deformation temperature will be higher than the deformation temperature of the shapeable parts 21 and 31, which can ensure that the brackets 22 and 32 are not affected during the shaping process of the shapeable parts 21 and 31. In addition, as Figure 3 shown, the shape of the user's dental arch curve can be roughly divided into various shapes such as oval arch, conical arch, square arch, etc. Therefore, the shape of the shapeable parts 21 and 31 can also adopt at least one of the forms such as oval arch, conical arch, square arch, etc. to conform to the user's dental arch curve.

[0089] The shapeable components 21, 31 are made of a flexible thermoplastic material, which is soft enough and has good elasticity and plasticity, and can be deformed after heating and maintain the deformation after cooling. This enables the shapeable components 21, 31 to better adapt to the shape and structure of the user's upper and lower teeth, providing better fit and comfort. Among them, the upper shapeable component 21 is configured to fit the user's upper dental arch, and the lower shapeable component 31 is configured to fit the user's lower dental arch. The upper shapeable component 21 is made of a plastic material and can be deformed when heated to achieve adaptability and adjustability to the user's upper jaw. The lower shapeable component 31 is made of a plastic material and can be deformed when heated to achieve adaptability and adjustability to the user's lower jaw. This design can ensure that the oral appliance 1 can accurately cover and fit the user's tooth surface, thereby providing better adaptability and comfort.

[0090] The brackets 22, 32 are made of a relatively rigid material at least in part compared to the shapeable components 21, 31. That is to say, at least part of the upper bracket and the lower bracket are made of a material with a higher stiffness than the upper shapeable component and the lower shapeable component, and the hardness range of this material is Shore D45 - Shore D95. The brackets 22, 32 have an inner wall 221 and an outer wall 222, and the distance between the inner wall 221 and the outer wall 222 is at least partly 0.3 - 8 mm, which is to provide the stability and support force required for the oral appliance 1. The rigid design of the brackets 22, 32 ensures that the oral appliance 1 is not easily deformed or loosened during use, maintaining its stability and functionality. This design can both maintain the overall structure stability of the oral appliance 1 and provide sufficient support, enabling the user to use the oral appliance 1 comfortably.

[0091] The shapeable components 21, 31 are configured to be detachably connected to the brackets 22, 32. As Figure 6 shown, the upper tray assembly 2 and / or the lower tray assembly 3 has a connecting part 5, and the connecting part 5 is configured to connect the shapeable components 21, 31 and the brackets 22, 32. Among them, the connecting part 5 includes protrusions 54, 55, grooves 52, 53 ( Figure 6 part A in) and / or additional components 56 such as pins, screws, dowels, magnets ( Figure 6Part B in the present invention), that is, the brackets 22 and 32 can be detachably connected to the shapeable components 21 and 31 in the form of buckles and / or additional external components. In the present utility model, the design of detachably connecting the shapeable components 21 and 31 to the brackets 22 and 32 is based on multiple considerations. First of all, since the shapeable components 21 and 31 are detachably connected to the brackets 22 and 32, and the disassembly and installation processes are simple and easy, the user can quickly and conveniently replace the shapeable components 21 and 31 without replacing the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only some components need to be replaced instead of the entire device, this design significantly reduces material waste, helps reduce resource consumption, and thus demonstrates significant environmental friendliness and climate friendliness. By reducing waste generation and reusing resources, the present utility model helps reduce carbon emissions and environmental load.

[0092] Secondly, the shapeable components 21 and 31 are made of plastic materials and can be deformed when heated, enabling the user to complete adaptive adjustment by self-heating and shaping. The user only needs to put the upper tray assembly 2 and the lower tray assembly 3 into hot water for heating, and then gently bite the upper tray assembly 2 and the lower tray assembly 3 with the mouth to make the upper tray assembly 2 and the lower tray assembly 3 fit well with the teeth, so as to shape the heated shapeable components 21 and 31 by biting to achieve fitting with the dental arch. If there are problems such as operation errors or improper biting during the biting process, since the shapeable components 21 and 31 are designed to be detachably connected to the brackets 22 and 32, the user can replace the shapeable components 21 and 31 again and perform biting again without replacing the entire device. This design not only significantly reduces the waste of resources and money, but also improves the adjustability of the device and the user experience.

[0093] Finally, the shapeable components 21 and 31 are made of flexible thermoplastic materials and are used to bear the biting force of the user, so their service life is usually shorter than that of the brackets 22 and 32. When the shapeable components 21 and 31 are damaged or need to be replaced, since they are designed to be detachably connected to the brackets 22 and 32, only the shapeable components 21 and 31 need to be replaced without replacing the entire device. In addition, if the brackets 22 and 32 need to be replaced while the shapeable components 21 and 31 can still be used, the shaped shapeable components 21 and 31 can be installed on the new brackets 22 and 32 without re-shaping. This design not only saves time, but also effectively reduces the waste of resources and money, significantly improving the economy and use efficiency of the device. By reducing material consumption and extending the service life of each component, it helps reduce carbon emissions and environmental load.

[0094] Such as Figure 7As shown, the projected area of the shapeable components 21 and 31 on the horizontal plane is greater than the projected area of the brackets 22 and 32 on the horizontal plane. That is, the ratio of the sum of the projected areas of the upper shapeable component 21 and the lower shapeable component 31 on the horizontal plane to the sum of the projected areas of the upper bracket 22 and the lower bracket 32 on the horizontal plane is greater than 1, so as to provide greater comfort and stability. Among them, the projected area of the brackets 22 and 32 on the horizontal plane is not greater than 60 square centimeters, and the lengths of the outwardly extending ends of the shapeable components 21 and 31 are both greater than the lengths of the outwardly extending ends of the brackets 22 and 32. The reason for designing the projected area of the shapeable components 21 and 31 on the horizontal plane to be greater than that of the brackets 22 and 32 is mainly as follows: First, the shapeable components 21 and 31 are made of flexible materials and are more likely to adapt to the oral cavity morphology, reducing irritation and scratching of the oral soft tissues. Second, since the projected area of the shapeable components 21 and 31 is relatively large, the contact pressure on the oral soft tissues can be reduced, thereby further reducing the risk of scratching. In addition, considering the differences in the distances from the inner side of the lips to the retromolar area among different users, an overly long device may cause scratching of the oral tissues in the retromolar area, especially in the area located at the joint, and a mismatched device may affect the occlusion function. The oral appliance 1 in this embodiment is designed to allow the user to adjust the length by trimming to adapt to the distance from the inner side of the lips to the retromolar area, and the soft shapeable components 21 and 31 enable the user to easily trim and independently adjust the device length according to personal needs, improving the comfort and personalized adaptability of use. It should be emphasized that the projected area of the shapeable components 21 and 31 on the horizontal plane is greater than that of the brackets 22 and 32. Therefore, trimming will not affect the brackets 22 and 32, thus ensuring the stability of the oral appliance 1. This design not only ensures the functionality of the oral appliance 1, but also gives the user more autonomy in adjustment, making the use of the oral appliance 1 more comfortable.

[0095] The following describes several structures of the oral appliance 1 of the present utility model in conjunction with specific examples.

[0096] Embodiment 1

[0097] The oral appliance 1 of this embodiment includes: an upper tray assembly 2 configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; a lower tray assembly 3 configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity. The upper tray assembly 2 includes an upper shapeable component 21 and an upper bracket 22; the lower tray assembly 3 includes a lower shapeable component 31 and a lower bracket 32. In this embodiment, the brackets 22 and 23 include the upper bracket 22 and the lower bracket 32, and the shapeable components 21 and 31 include the upper shapeable component 21 and the lower shapeable component 31.

[0098] The shapeable components 21 and 31 are made of a shapeable material and can be deformed when heated. The brackets 22 and 32 do not deform when heated to the temperature required for the deformation of the shapeable components 21 and 31. The shapeable components 21 and 31 are configured to be detachably connected to the brackets 22 and 32. The upper tray assembly 2 and / or the lower tray assembly 3 has a connecting portion 5, and the connecting portion 5 is configured to connect the shapeable components 21 and 31 and the brackets 22 and 32. Among them, the connecting portion 5 includes protrusions 54, 55, and grooves 52, 53.

[0099] On the same tray assembly 2 and 3, the shapeable components 21 and 31 have at least one protrusion 54, 55, and the brackets 22 and 32 have at least one groove 52, 53. For better fixing effect, it is preferred that the shapeable components 21 and 31 and the brackets 22 and 32 respectively have 4 protrusions 54, 55 and grooves 52, 53, that is, symmetrically distributed on both sides adjacent to the middle part (i.e., the position of the oral appliance close to the user's front teeth) and at both ends (i.e., one end of the oral appliance close to the user's temporomandibular joint). As Figure 8 , Figure 9 shown, taking the upper tray assembly 2 as an example, the upper shapeable component 21 has 4 protrusions 54, 55, where 2 protrusions 54 are located on both sides adjacent to the middle part of the upper shapeable component 21, and the other 2 protrusions 55 are located at both ends of the upper shapeable component 21. The upper bracket 22 has 4 grooves 52, 53 corresponding to the protrusions 54, 55.

[0100] The protrusions 54, 55 are located on the shapeable components 21, 31 and are matched with the grooves 52, 53 on the brackets 22, 32. The protrusions 54, 55 and the shapeable components 21, 31 are integrally formed and are set in a shape that is easy to produce, install and detach, that is, the shape of the protrusions 54, 55 adopts at least one of cylindrical, square, spherical, T-shaped, L-shaped or other shapes. The brackets 22, 32 include an inner wall 221 and an outer wall 222, and the inner wall 221 of the bracket forms a cavity for accommodating the shapeable components 21, 31. During the installation process, the shapeable components 21, 31 are placed on the brackets 22, 32 so that the outer wall 211 of the shapeable components 21, 31 is at least partially in contact with the inner wall 221 of the brackets 22, 32, and then the protrusions 54, 55 on the shapeable components 21, 31 are inserted into the grooves 52, 53 at the corresponding positions of the brackets 22, 32. Among them, the grooves 52, 53 on the brackets 22, 32 have a sufficient depth, and the depth range is between 0.2 - 20 mm, forming a stable connection with the protrusions 54, 55 on the shapeable components 21, 31.

[0101] Embodiment 2

[0102] The oral appliance 1 of this embodiment includes: an upper tray assembly 2 configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; and a lower tray assembly 3 configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity. The upper tray assembly 2 includes an upper deformable member 21 and an upper bracket 22; the lower tray assembly 3 includes a lower deformable member 31 and a lower bracket 32. In this embodiment, the brackets 22, 23 include the upper bracket 22 and the lower bracket 32, and the deformable members 21, 31 include the upper deformable member 21 and the lower deformable member 31.

[0103] The deformable members 21, 31 are made of a deformable material and can be deformed when heated, and the brackets 22, 32 do not deform when heated to the temperature required for the deformation of the deformable members 21, 31. The deformable members 21, 31 are configured to be detachably connected to the brackets 22, 32. The upper tray assembly 2 and / or the lower tray assembly 3 has a connecting portion 5 configured to connect the deformable members 21, 31 and the brackets 22, 32. Among them, the connecting portion 5 includes protrusions 54, 55, and grooves 52, 53.

[0104] The difference between this embodiment and Embodiment 1 is that the protrusions and grooves of the deformable members 21, 31 and the brackets 22, 32 are arranged in reverse, but the functions are the same. The grooves 52, 53 are located on the deformable members 21, 31 and match the protrusions 54, 55 on the brackets 22, 32. The brackets 22, 32 include an inner wall 221 and an outer wall 222, and the inner wall 221 of the bracket forms a cavity for accommodating the deformable members 21, 31. The grooves 52, 53 are located on the deformable members 21, 31 and have shapes corresponding to the protrusions 54, 55. For better fixing effect, preferably, the brackets 22, 23 and the deformable members 21, 31 respectively have 4 protrusions 54, 55 and grooves 52, 53, that is, they are symmetrically distributed on both sides adjacent to the middle part (i.e., the position of the oral appliance close to the user's front teeth) and at both ends (i.e., one end of the oral appliance close to the user's temporomandibular joint). Taking the upper tray assembly 2 as an example, as Figure 10 shown, 4 grooves 52, 53 are provided on the upper deformable member 21, where 2 grooves 52 are located on both sides adjacent to the middle part of the upper deformable member 21, and the other 2 grooves 53 are located at both ends of the upper deformable member 21.

[0105] In other embodiments, the grooves 53 at both ends of the deformable members 21, 31 exist in the form of covering both ends of the brackets 22, 32, such as Figure 11 、 Figure 12As shown, the shapeable components 21, 31 extend from both ends of the brackets 22, 32 for a part and then extend in the opposite direction, forming a hollow groove 53 to wrap the protrusions 55 of the brackets 22, 32. This structure makes the two ends of the shapeable components 21, 31 longer than those of the brackets 22, 32, avoiding the rigid brackets 22, 32 touching the retromolar area of the user's molars. Instead, the softer shapeable components 21, 31 are used to better adapt to the oral cavity morphology and reduce the irritation and scratching of the user's retromolar area.

[0106] Embodiment 3

[0107] The oral appliance 1 of this embodiment includes: an upper tray assembly 2 configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; a lower tray assembly 3 configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity. The upper tray assembly 2 includes an upper shapeable component 21 and an upper bracket 22; the lower tray assembly 3 includes a lower shapeable component 31 and a lower bracket 32. In this embodiment, the brackets 22, 23 include the upper bracket 22 and the lower bracket 32, and the shapeable components 21, 31 include the upper shapeable component 21 and the lower shapeable component 31.

[0108] The shapeable components 21, 31 are made of a shapeable material and can be deformed when heated, while the brackets 22, 32 do not deform when heated to the temperature required for the deformation of the shapeable components 21, 31. The shapeable components 21, 31 are configured to be detachably connected to the brackets 22, 32. The upper tray assembly 2 and / or the lower tray assembly 3 has a connecting part 5, and the connecting part 5 is configured to connect the shapeable components 21, 31 and the brackets 22, 32. Among them, the connecting part 5 includes protrusions 54, 55, and grooves 51, 52, 53.

[0109] In this embodiment, the shapeable components 21, 31 at least have protrusions 54, 55, and the brackets 22, 32 have grooves 51, 52, 53. Among them, the protrusions 54, 55 of the shapeable components 21, 31 correspond to the grooves 52, 53 of the brackets 22, 32. In addition, the brackets 22, 32 include an inner wall 221, an outer wall 222, and a groove 51, and the distance between the inner wall 221 and the outer wall 222 is at least partially 0.3 - 8 mm. When the user puts the oral appliance 1 into hot water for heating and gently bites the oral appliance 1 with the mouth, the shapeable components 21, 31 are deformed due to the bite, and the excess part overflows from all around, which will not only cause discomfort due to the protrusions on the surface of the oral appliance 1 but also affect the aesthetics. Therefore, in this embodiment, a groove 51 is provided on the brackets 22, 32 and is configured to accommodate the material overflowing from the shapeable components 21, 31 during the hot melting process. As Figure 13 shown, the groove 51 penetrates the inner wall 221 and the outer wall 222 of the brackets 22, 32 (as Figure 13Part A), when the plasticizable components 21 and 31 are heat-melted, they overflow from the groove 51. Due to the different structures and material properties of the plasticizable components 21 and 31, sufficient grooves need to be provided to accommodate the overflowing material. The horizontal area of the groove 51 is at least 3 square millimeters. When the plasticizable components 21 and 31 are cooled, the material overflowing from the groove 51 forms protrusions after cooling (such as Figure 13 Part B), which further enhances the fixing effect between the brackets 22 and 32 and the plasticizable components 21 and 31.

[0110] In addition, the technical features in the above embodiments can be combined as needed to obtain the oral appliance 1 including all or part of the above technical features.

[0111] The oral appliance 1 with a foam pad implementing the present utility model has at least the following beneficial effects:

[0112] 1) Since the plasticizable components 21 and 31 and the brackets 22 and 32 are designed to be detachably connected, and the disassembly and installation processes are simple and easy, the user can quickly and conveniently replace the plasticizable components 21 and 31 without replacing the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only some components need to be replaced instead of the entire device, this design significantly reduces the waste of materials, helps reduce resource consumption, and thus demonstrates significant environmental friendliness and climate friendliness. By reducing waste generation and resource reuse, the present utility model helps reduce carbon emissions and environmental load.

[0113] 2) The plasticizable components 21 and 31 are made of plasticizable materials and can be deformed when heated. The user can put the heated plasticizable components 21 and 31 into the oral cavity and shape them by biting to fit the dental arch. If there are problems such as operation errors or improper biting during the biting process, since the plasticizable components 21 and 31 and the brackets 22 and 32 are designed to be detachably connected, the user can replace the plasticizable components 21 and 31 again and bite again without replacing the entire device. This design not only significantly reduces the waste of resources and money, but also improves the adjustability of the device and the user experience.

[0114] 3) The shapeable components 21 and 31 are made of flexible thermoplastic materials and are used to withstand the biting force of the user. Therefore, their lifespan is usually shorter than that of the brackets 22 and 32. When the shapeable components 21 and 31 are damaged or need to be replaced, since they are designed to be detachably connected to the brackets 22 and 32, only the shapeable components 21 and 31 need to be replaced, rather than the entire device. In addition, if the brackets 22 and 32 need to be replaced while the shapeable components 21 and 31 can still be used, the shaped shapeable components 21 and 31 can be installed on the new brackets 22 and 32 without the need for reshaping. This design not only saves time but also effectively reduces the waste of resources and money, significantly improving the economy and usage efficiency of the device. By reducing material consumption and extending the service life of each component, it helps to reduce carbon emissions and the environmental load.

[0115] 4) The brackets 22 and 32 are provided with grooves 51, 52, and 53. These grooves 51, 52, and 53 can not only fix the protrusions 54 and 55 of the shapeable components 21 and 31 therein but also accommodate the materials overflowed by the shapeable components 21 and 31 during the hot melting process. The overflowed materials fill the groove 51 after cooling, further enhancing the fixing effect between the brackets 22 and 32 and the shapeable components 21 and 31. By designing the groove structure on the brackets 22 and 32, the present utility model realizes the double fixation of the shapeable components 21 and 31, which not only improves the stability of the connection but also simplifies the installation process, ensuring the reliability of the device during use. In addition, the structure of the connection part 5 between the brackets 22 and 32 and the shapeable components is relatively simple, enabling the shapeable components 21 and 31 to be easily removed from the brackets 22 and 32, thus realizing the detachable function of the device and facilitating maintenance and replacement.

[0116] 5) Compared with the brackets 22 and 32, the shapeable components 21 and 31 are made of flexible materials, which can better adapt to the oral cavity morphology, reducing the irritation and scratching of the oral soft tissues. At the same time, the horizontal projection area of the shapeable components 21 and 31 is larger than that of the brackets 22 and 32, which helps to reduce the contact pressure on the oral soft tissues and further reduce the risk of scratching. Considering the differences in the distance from the inner side of the lip to the retromolar area among different users, the design of the oral appliance 1 of the present utility model allows the user to adjust the length by trimming to adapt to the distance from the inner side of the lip to the retromolar area. The soft shapeable components 21 and 31 enable the user to easily perform trimming and independently adjust the length of the device according to personal needs, thereby improving the comfort and personalized adaptability of use. It should be noted that since the horizontal projection area of the shapeable components 21 and 31 is larger than that of the brackets 22 and 32, trimming will not affect the structure and function of the brackets 22 and 32, thus ensuring the stability and effectiveness of the oral appliance 1.

[0117] 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-described 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 recorded in this specification.

[0118] The above-described embodiments merely represent several implementation manners of the present utility model. The description 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 belong to 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. An oral appliance, characterized in that, Comprising: An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity; The upper tray assembly includes an upper moldable member and an upper bracket; The lower tray assembly includes a lower moldable member and a lower bracket; Wherein, the upper moldable member and the lower moldable member are made of a malleable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper moldable member and the lower moldable member; The upper moldable member is configured to be detachably connected to the upper bracket; The lower moldable member is configured to be detachably connected to the lower bracket; The upper moldable member and the lower moldable member have outer walls; The upper bracket and the lower bracket have inner walls; The outer walls of the upper moldable member and the lower moldable member are at least partially in contact with the inner walls of the upper bracket and the lower bracket respectively.

2. The oral appliance according to claim 1, wherein The shape of the upper tray assembly is configured as an arched structure conforming to the curve of the user's maxillary dentition.

3. The oral appliance according to claim 1, wherein The shape of the lower tray assembly is configured as an arched structure conforming to the curve of the user's mandibular dentition.

4. The oral appliance according to claim 1, characterized in that, At least part of the upper moldable member and the lower moldable member are made of a flexible thermoplastic material.

5. The oral appliance according to claim 1, wherein At least part of the upper bracket and the lower bracket are made of a material with a higher stiffness than the upper moldable member and the lower moldable member.

6. An oral appliance, characterized in that, Comprising: An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity; The upper tray assembly includes an upper moldable member and an upper bracket; The lower tray assembly includes a lower moldable member and a lower bracket; Wherein, the upper moldable member and the lower moldable member are made of a malleable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper moldable member and the lower moldable member; The upper moldable member is configured to be detachably connected to the upper bracket; The lower moldable member is configured to be detachably connected to the lower bracket; The projected area of the upper moldable member in the horizontal plane is greater than the projected area of the upper bracket in the horizontal plane; The projected area of the lower moldable member in the horizontal plane is greater than the projected area of the lower bracket in the horizontal plane.

7. The oral appliance according to claim 6, wherein The upper moldable member and the lower moldable member are made of a malleable material, and the temperature required for heating to deformation is less than 100 degrees Celsius.

8. The oral appliance according to claim 6, wherein The upper bracket and the lower bracket are made of a material with high temperature stability, and the temperature required for heating to deformation is greater than 100 degrees Celsius.

9. The oral appliance according to claim 6, wherein The ratio of the sum of the projected areas of the upper moldable member and the lower moldable member in the horizontal plane to the sum of the projected areas of the upper bracket and the lower bracket in the horizontal plane is greater than 1.

10. The oral appliance according to claim 6, wherein The lengths of the outwardly extending ends of the upper moldable member and the lower moldable member are both greater than the lengths of the outwardly extending ends of the upper bracket and the lower bracket.

11. An oral appliance, characterized in that, Comprising: An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; The lower tray assembly is configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity; The upper tray assembly includes an upper shapeable member and an upper bracket; The lower tray assembly includes a lower shapeable member and a lower bracket; The upper tray assembly and / or the lower tray assembly has a connecting portion configured to connect the upper shapeable member and the upper bracket and connect the lower shapeable member and the lower bracket, respectively; Wherein, the upper shapeable member and the lower shapeable member are made of a shapeable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper shapeable member and the lower shapeable member; The upper shapeable member is configured to be detachably connected to the upper bracket; The lower shapeable member is configured to be detachably connected to the lower bracket.

12. The oral appliance according to claim 11, wherein The upper bracket and the lower bracket are detachably connected to the upper shapeable member and the lower shapeable member, respectively, through additional external members.

13. The oral appliance according to claim 11, wherein, The connecting portion includes protrusions, grooves and / or external members such as pins, screws, pins, magnets.

14. The oral appliance according to claim 13, wherein, The shape of the protrusion adopts at least one of cylindrical, square, spherical, T-shaped, L-shaped.

15. The oral appliance according to claim 13, wherein The protrusions are located on the upper shapeable member and the lower shapeable member and respectively match the grooves on the upper bracket and the lower bracket.

16. The oral appliance according to claim 13, wherein, The grooves are located on the upper shapeable member and the lower shapeable member and respectively match the protrusions on the upper bracket and the lower bracket.

17. An oral appliance, characterized in that, Including: An upper tray assembly configured to be adjacent to the user's maxillary dentition when positioned in the user's oral cavity; A lower tray assembly configured to be adjacent to the user's mandibular dentition when positioned in the user's oral cavity; The upper tray assembly includes an upper shapeable member and an upper bracket; The lower tray assembly includes a lower shapeable member and a lower bracket; Wherein, the upper shapeable member and the lower shapeable member are made of a shapeable material and can be deformed when heated, and the upper bracket and the lower bracket do not deform when heated to the temperature required for the deformation of the upper shapeable member and the lower shapeable member; The upper shapeable member is configured to be detachably connected to the upper bracket; The lower shapeable member is configured to be detachably connected to the lower bracket; The upper bracket and / or the lower bracket has at least one groove.

18. The oral appliance according to claim 17, wherein The grooves of the upper bracket and the lower bracket are configured to accommodate the materials overflowed by the upper shapeable member and the lower shapeable member during the hot melting process.

19. The oral appliance according to claim 17, wherein, The shapes of the upper shapeable member and the lower shapeable member adopt at least one of oval arch, conical arch, square arch to conform to the dental arch curve of the user.

20. The oral appliance according to claim 17, wherein Both the upper bracket and the lower bracket have an inner wall and an outer wall, and the distance between the inner wall and the outer wall is at least part of 0.3 - 8 mm.

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