Moldable oral appliance

Abstract

The utility model provides a moldable oral appliance. The moldable oral appliance comprises an upper tray assembly and a lower tray assembly, the upper tray assembly is characterized in that the upper tray assembly is provided with an upper moldable part and an upper support; the lower tray assembly comprises a lower moldable part and a lower support. The upper shapeable part and the lower shapeable part are made of plastic materials and can be deformed when heated, and the upper support and the lower support do not deform when heated to the temperature required by deformation of the upper shapeable part and the lower shapeable part. The upper moldable member and the lower moldable member each have at least one groove.

Description

Technical Field

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

[0002] In modern medicine, sleep problems have become a health field that has attracted much attention. Snoring and obstructive sleep apnea are two common sleep disorders, which not only affect the sleep quality of patients, but may also lead to a series of health problems. At the same time, the technology in the field of oral appliances is also constantly developing, providing new treatment options for solving these sleep problems.

[0003] Snoring is a noise generated during sleep due to the relaxation of tissues in the throat, which causes airflow obstruction. During sleep, tissues such as the tongue and soft palate may collapse, resulting in a narrow airflow channel, causing vibration when air passes through and generating a harsh snoring sound. This phenomenon not only disturbs the sleep of the patient himself, but may also affect the sleep of his roommate or family members. Obstructive sleep apnea is more serious, which is a phenomenon of apnea caused by partial or complete obstruction of the throat, resulting in repeated breathing stops during sleep, seriously affecting oxygen supply, possibly leading to a decrease in blood oxygen level, and further causing damage to the cardiovascular system and the brain.

[0004] To solve sleep problems such as snoring and obstructive sleep apnea, there are currently various prevention and treatment methods available. Oral appliances are considered to be an effective option among them. One common oral appliance is the Mandibular Advancement Device (MAD). This appliance increases the airflow in the throat channel by pushing the position of the mandible relative to the maxilla, thereby reducing or eliminating the occurrence of snoring and obstructive sleep apnea. In addition to MAD, the Tongue Retaining Device (TRD) and the Tongue Stabilizing Device (TSD) are also common oral appliances, which maintain the patency of the throat by supporting the position of the tongue and reduce the occurrence of sleep apnea.

[0005] In addition to traditional oral appliances, the progress of modern technology has also brought new options for the treatment of sleep disorders. Smart oral appliances combine sensor technology and data analysis, can monitor the sleep situation of users in real time, and adjust the usage mode of the appliance according to needs, providing personalized treatment plans. In addition, the application of 3D printing technology also provides a more precise method for the customization of oral appliances, making the appliances more conform to the oral morphology of users, improving the comfort and treatment effect.

[0006] Despite the continuous progress of technology in the field of oral appliances, some challenges still remain. Some users may feel uncomfortable with the use of the appliance, thus affecting the treatment effect; others may encounter discomfort or occlusal discomfort during use. In addition, the cost of using the appliance is also a factor for users to consider whether to continue using it. Summary of the Utility Model

[0007] Based on this, in view of the above deficiencies, a moldable oral appliance that is effective, comfortable and affordable is provided.

[0008] A moldable oral appliance includes:

[0009] An upper tray assembly configured to be positioned on the maxillary dentition of a user;

[0010] A lower tray assembly configured to be positioned on the mandibular dentition of a user;

[0011] The upper tray assembly includes an upper moldable member and an upper bracket;

[0012] The lower tray assembly includes a lower moldable member and a lower bracket;

[0013] Wherein, the upper moldable member and the lower moldable member are made of a moldable material, which 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;

[0014] Each of the upper moldable member and the lower moldable member has at least one groove;

[0015] The groove includes a first groove, and the first groove has a front wall and a rear wall, and the distance between the front wall and the rear wall is at least partially variable.

[0016] In one embodiment, the materials of the upper moldable member and the lower moldable member are medical-grade moldable materials.

[0017] In one embodiment, the upper moldable member and the lower moldable member will not damage their materials or properties during the deformation process.

[0018] In one embodiment, the upper moldable member and the lower moldable member allow minor deformations in a state of maintaining the deformed shape.

[0019] In one embodiment, the width in the middle of the first groove is smaller than the widths on both sides of the first groove.

[0020] In one embodiment, the height in the middle of the first groove is greater than the heights on both sides of the first groove.

[0021] The present utility model also discloses a shapeable oral appliance, comprising:

[0022] an upper tray assembly configured to be positioned on the maxillary dentition of a user;

[0023] a lower tray assembly configured to be positioned on the mandibular dentition of a user;

[0024] The upper tray assembly includes an upper shapeable member and an upper bracket;

[0025] The lower tray assembly includes a lower shapeable member and a lower bracket;

[0026] 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;

[0027] The upper shapeable member and the lower shapeable member each have a first groove;

[0028] The upper shapeable member and the lower shapeable member each have at least a part of the second groove in any cross-section perpendicular to the horizontal plane, and the second groove is configured to prevent the upper shapeable member and the lower shapeable member from overflowing the defined range during the heating and shaping process.

[0029] In one embodiment, at least a part of the upper shapeable member and the lower shapeable member is made of a flexible thermoplastic material.

[0030] In one embodiment, at least a part of the upper bracket and the lower bracket is made of a material that is relatively rigid compared to the upper shapeable member and the lower shapeable member to ensure the structural stability and support of the oral appliance.

[0031] In one embodiment, the first groove is used to accommodate the teeth of the user.

[0032] In one embodiment, the upper shapeable member and the lower shapeable member do not produce harmful substances or odors during the heating and shaping process.

[0033] The present utility model also discloses a shapeable oral appliance, comprising:

[0034] an upper tray assembly configured to be positioned on the maxillary dentition of a user;

[0035] a lower tray assembly configured to be positioned on the mandibular dentition of a user;

[0036] The upper tray assembly includes an upper shapeable member and an upper bracket;

[0037] The lower tray assembly includes a lower deformable member and a lower bracket;

[0038] Wherein, the upper deformable member and the lower deformable member 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 member and the lower deformable member;

[0039] The upper deformable member and the lower deformable member each have at least one groove;

[0040] The projected area of the upper deformable member on the horizontal plane is larger than the projected area of the upper bracket on the horizontal plane;

[0041] The projected area of the lower deformable member on the horizontal plane is larger than the projected area of the lower bracket on the horizontal plane.

[0042] In one embodiment, at least a part of the heights of the upper deformable member and the lower deformable member is 0.5 - 30 mm.

[0043] In one embodiment, the upper bracket and the lower bracket each have an outer wall, and the upper deformable member and the lower deformable member at least partially cover the top of the outer wall.

[0044] In one embodiment, the height of the upper deformable member and the lower deformable member covering the top of the outer wall is 0 - 30 mm.

[0045] In one embodiment, the width of the upper deformable member and the lower deformable member covering the top of the outer wall is 0 - 10 mm.

[0046] The present utility model also discloses a deformable oral appliance, comprising:

[0047] An upper tray assembly configured to be positioned on the maxillary dentition of a user;

[0048] A lower tray assembly configured to be positioned on the mandibular dentition of a user;

[0049] The upper tray assembly includes an upper deformable member and an upper bracket;

[0050] The lower tray assembly includes a lower deformable member and a lower bracket;

[0051] Wherein, the upper deformable member and the lower deformable member 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 member and the lower deformable member;

[0052] The upper deformable member and the lower deformable member each have a first groove;

[0053] The upper shapeable component and the lower shapeable component each have a second groove;

[0054] The upper shapeable component and the lower shapeable component have one or more of the following characteristics:

[0055] The first groove has a bottom wall, and the vertical distance between the bottom wall and the upper bracket and / or the lower bracket ranges from 1 to 15 mm;

[0056] The second groove has a bottom wall, and the vertical distance between the bottom wall and the upper bracket and / or the lower bracket ranges from 0.5 to 15 mm;

[0057] The projected area of the first groove on the horizontal plane occupies 10-90% of the projected area of the upper shapeable component and / or the lower shapeable component on the horizontal plane.

[0058] In one embodiment, the second groove has a front wall and a rear wall, and the distance between the front wall and the rear wall ranges from 0.1 to 10 mm.

[0059] In one embodiment, the height in the middle of the upper shapeable component is greater than the height at both ends of the upper shapeable component, and the height in the middle of the lower shapeable component is greater than the height at both ends of the lower shapeable component.

[0060] In one embodiment, the shape of the upper tray assembly is configured as an arched structure that conforms to the curve of the user's upper dental arch.

[0061] In one embodiment, the shape of the lower tray assembly is configured as an arched structure that conforms to the curve of the user's lower dental arch.

[0062] Implementing the shapeable oral appliance of the present utility model has at least the following beneficial effects:

[0063] 1) The shapeable component is made of a flexible thermoplastic material and has good adaptability, and can effectively adapt to the shape of the user's oral cavity. The design of the shapeable component covers most areas of the oral appliance, especially the parts that are easily scratched. This design effectively reduces the friction between the oral appliance and the oral tissue, so that the user feels more comfortable during wearing.

[0064] 2) The shapeable component is provided with a first groove and a second groove, aiming to provide a better shaping effect during the heating and shaping process. During heating and shaping, the first groove is used to accommodate the user's teeth. When the user performs occlusion shaping, the shaping material on the front and rear walls of the first groove is squeezed, and the excess material will move away from the teeth on both sides respectively. The excess material may overflow from the boundary of the oral appliance, thereby reducing the adaptability and wearing comfort of the appliance. The setting of the second groove effectively solves this problem. It is set on the moving path of the excess material. During the extrusion process, the excess material will automatically flow into the second groove, thereby controlling the flow of the shaping material and avoiding the overflow of excess material during the shaping process. This design not only improves the fit and comfort of the oral appliance, but also reduces material waste, bringing a better user experience to the user. At the same time, this design also makes the oral appliance more economical and environmentally friendly during the production process.

[0065] 3) The shapeable component has a first groove, which is set at the central position of the shapeable component and is used to accommodate the user's teeth. Considering the differences in the sizes of different teeth, the distance between the front wall and the rear wall of the groove is adjusted accordingly. The central incisor part is usually narrower and thinner, suitable for cutting and tearing food; the molar part is usually wider and thicker, more suitable for chewing and grinding food. In addition, there are also differences between the maxillary dentition and the mandibular dentition. Therefore, the size of the first groove is set to adapt to the shapes of different teeth: for example, the width in the middle (central incisor position) is smaller than that on both sides (molar position), and the height in the middle (central incisor position) is greater than that on both sides (molar position). This design helps the oral appliance to better fit the user's teeth, making it easier and more accurate for the user to shape the oral appliance.

[0066] 4) The height of the shapeable component varies at different positions. This design takes into account the curve characteristics of the oral structure, so height differences are set in its shape. At the same time, the overall shape of the tray assembly also takes into account the curve characteristics of the oral structure and also sets height differences. As part of the tray assembly, the overall shape of the shapeable component correspondingly adapts to the height differences of the tray assembly to ensure that the oral appliance fits better with the user's teeth and oral structure, providing better comfort and user experience. When the user performs occlusion, the shapeable component can form a closer contact with the teeth and oral structure, effectively improving the fit of the oral appliance. At the same time, this design makes it more convenient for the user to perform occlusion. This design not only improves the adaptability and fit of the oral appliance, but also improves the comfort of the user when wearing the oral appliance, thereby improving the treatment effect and user experience.

[0067] 5) The shapeable component is made of a flexible material. Compared with the bracket, it is easier to adapt to the oral cavity morphology, reducing the irritation and scratching of the oral soft tissues. Therefore, by setting the horizontal plane projection area of the shapeable component to be larger than that of the bracket, the contact pressure of the oral appliance on the oral soft tissues can be reduced, 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, the oral appliance design of the present utility model allows users to adjust the length by trimming to adapt to this distance. The soft shapeable component enables users to easily trim and independently adjust the device length according to their 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, thereby ensuring the stability of the oral appliance. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0070] Figure 3 is a schematic diagram of the horizontal plane, sagittal plane, and coronal plane in multiple embodiments of the present utility model;

[0071] Figure 4 is a top view of the upper tray assembly in an embodiment of the present utility model;

[0072] Figure 5 In an embodiment of the present utility model, the upper tray assembly is in Figure 4 a sectional view in the A-A direction;

[0073] Figure 6 In an embodiment of the present utility model, the upper tray assembly is in Figure 4 a sectional view in the B-B direction;

[0074] Figure 7 is a schematic diagram of the horizontal projection planes of the upper shapeable component and the upper bracket in an embodiment of the present utility model;

[0075] Figure 8 is a side view of the upper tray assembly in an embodiment of the present utility model;

[0076] Figure 9 is a partial sectional view of the upper tray assembly in Embodiment 1 of the present utility model;

[0077] Figure 10 is a schematic diagram of the area of the first groove of the upper shapeable component on the horizontal plane in Embodiment 1 of the present utility model;

[0078] Figure 11 Schematic diagram of the position where the maxillary dentition is placed on the upper tray assembly in the first embodiment of the present utility model;

[0079] Figure 12 Partial cross-sectional view of the first groove in the upper tray assembly in the first embodiment of the present utility model;

[0080] Figure 13 Partial cross-sectional view of the second groove in the upper tray assembly in the first embodiment of the present utility model;

[0081] Figure 14 Schematic diagram of the distribution position of the second groove of the shapeable component in the first embodiment of the present utility model. Detailed implementation manners

[0082] 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 with reference to 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.

[0083] 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 can also be used as a mouthguard for the maxillary dentition, the mandibular dentition or both dentitions. In some embodiments, such an appliance can also be used as a bruxism appliance for the maxillary dentition, the mandibular dentition or both dentitions.

[0084] The present utility model provides an effective, comfortable and cost-effective shapeable oral appliance 1.

[0085] Specifically, please refer to Figures 1 to 3 , the oral appliance 1 of 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 positioned on the user's maxillary dentition; the lower tray assembly 3 is configured to be positioned on the user's mandibular dentition. The tray assemblies 2 and 3 are designed to match the shape and structure of the user's dentition, and can provide sufficient support and stability for the oral appliance 1. Therefore, the shapes of the upper and lower tray assemblies 2 and 3 are configured as an arched structure that conforms to the curve of the user's dentition, so as to better fit the upper and lower teeth of the user.

[0086] The upper tray assembly 2 includes an upper plasticizable member 21 and an upper bracket 22, and the lower tray assembly 3 includes a lower plasticizable member 31 and a lower bracket 32. In the present utility model, the tray assemblies 2, 3 include the upper tray assembly 2 and the lower tray assembly 3, the brackets 22, 32 include the upper bracket 22 and the lower bracket 32, and the plasticizable members 21, 31 include the upper plasticizable member 21 and the lower plasticizable member 31. The materials of the upper tray assembly 2 and the lower tray assembly 3 can be selected from a wide range, 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), polyphenylsulfone (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, and are suitable for the manufacture of the oral appliance 1. Each part of the upper tray assembly 2 and the lower tray assembly 3, such as the plasticizable members 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 and are suitable for the manufacture of the oral appliance 1.

[0087] The upper malleable part 21 and the lower malleable part 31 are made of malleable materials, preferably thermoplastics, enabling users to complete the adaptive adjustment of the oral appliance 1 by self-heating and shaping. Among them, the heating and shaping method adopts the "boiling and biting" method, 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 the user's teeth and shape. The upper malleable part 21 and the lower malleable part 31 are made of malleable materials and can be deformed when heated. The upper bracket 22 and the lower bracket 32 do not deform when heated to the temperature required for the deformation of the upper malleable part 21 and the lower malleable part 31. This design ensures the stability and reliability of the oral appliance 1 during the shaping process, enabling users to easily complete the adaptive adjustment and obtain a better user experience.

[0088] It is worth noting that if the brackets 22, 32 also adopt thermoplastics, their deformation temperature will be higher than that of the malleable parts 21, 31, which can ensure that the brackets 22, 32 will not be affected during the heating and shaping process. In addition, since different parts of the oral appliance 1 have different functions, it is necessary to pay attention not to affect the original functions during the heating and shaping process. By maintaining the stability and shape of the brackets 22, 32 unchanged, even when the malleable parts 21, 31 are being shaped, the basic functions of the oral appliance 1 can be ensured not to be affected. This design comprehensively considers the characteristics of different parts, ensuring the smooth progress of the entire heating and shaping process, as well as the reliability and stability of the final effect.

[0089] In addition, there are several requirements for the material selection of the upper malleable part 21 and the lower malleable part 31. First, medical-grade malleable materials are used, meeting medical-grade standards to ensure the safety and reliability of the oral appliance 1. Second, the malleable parts 21, 31 will not damage their materials or properties during the deformation process. This means that during the heating and shaping process, the materials must be able to withstand high temperatures without cracking or deterioration to ensure the quality and stability of the oral appliance 1. At the same time, the malleable parts 21, 31 will not produce harmful substances or odors during the heating and shaping process to ensure the safety and comfort of users. Finally, the malleable parts 21, 31 are allowed to have slight deformations while maintaining the deformed shape. The malleable parts 21, 31 are at least partially made of flexible thermoplastics. After heating and shaping, their shapes are shaped to fit the shape of the teeth and maintain the shaped shape. In addition, due to the characteristics of the flexible thermoplastics used, during the wearing process, if the user applies a biting force, the material will exhibit a certain degree of elasticity and toughness, thus allowing the malleable parts 21, 31 to have slight deformations when adapting to the acting force of tooth occlusion. This kind of deformation will not cause the completely change of the shaped shape, but makes the wearing more comfortable, while ensuring the stability and adaptability of the malleable parts 21, 31.

[0090] The heights of the moldable components 21 and 31 vary at different positions. For example, Figure 5 , Figure 6 as shown, the overall height of the moldable components 21 and 31 is 0.5 - 30 mm, and the height in the middle (the position of the central incisors, as Figure 5 shown) is greater than the heights at both ends (the positions of the molars, as Figure 6 shown). This design takes into account the curved characteristics of the oral structure, so a height difference is set in its shape. At the same time, the overall shapes of the upper tray assembly 2 and the lower tray assembly 3 also consider the curved characteristics of the oral structure, and a height difference is also set. As part of the upper tray assembly 2 and the lower tray assembly 3, the overall shapes of the moldable components 21 and 31 correspondingly adapt to the height difference of the upper tray assembly 2 and the lower tray assembly 3 to ensure that the oral appliance 1 fits better with the user's teeth and oral structure, providing better comfort and user experience. When the user bites, the moldable components 21 and 31 can form a closer contact with the teeth and oral structure, effectively improving the fitting degree of the oral appliance 1. At the same time, this design makes it more convenient for the user to bite. This design not only improves the adaptability and fitting degree of the oral appliance 1, but also improves the comfort of the user when wearing the oral appliance 1, thus improving the treatment effect and user experience.

[0091] At least part of the brackets 22 and 32 are made of materials that are relatively rigid compared to the moldable components 21 and 31 to ensure the structural stability and support of the oral appliance 1, which is to provide the stability and support force required for the oral appliance 1. The rigid design of the brackets 22 and 32 ensures that the oral appliance 1 will not deform or loosen during use, maintaining its stability and functionality. This design can not only keep the overall structure of the oral appliance 1 stable, but also provide sufficient support, enabling the user to use the oral appliance 1 comfortably.

[0092] As Figure 4 and Figure 5 shown, the brackets 22 and 32 have outer walls 221. When wearing the oral appliance 1, the upper and lower tops are the parts that are most likely to come into contact with the inside of the oral cavity. If the tops are covered by relatively rigid brackets, it is easy to cause scratches. Therefore, in the present utility model, at least part of the moldable components 21 and 31 cover the top 2211 of the outer wall 221 of the brackets. The width of the part where the moldable components 21 and 31 at least cover the top 2211 of the outer wall 221 of the brackets is 0 - 10 mm, that is, Figure 5 w1 in Figure 5The h1 in it. The shapeable components 21 and 31 are made of flexible thermoplastic materials, having good adaptability and being able to effectively adapt to the shape of the user's oral cavity. Their design covers most of the areas where the oral appliance 1 contacts the oral cavity, especially the places that are prone to scratching. This design effectively reduces the friction between the oral appliance 1 and the oral tissues, thus making the user feel more comfortable during wearing.

[0093] As Figure 7 , Figure 8 shown, the projected area of the upper shapeable component 21 in the horizontal plane (i.e., the plane perpendicular to the sagittal plane and the coronal plane) is larger than the projected area of the upper bracket 22 in the horizontal plane, and the projected area of the lower shapeable component 31 in the horizontal plane is larger than the projected area of the lower bracket 32 in the horizontal plane. The lateral width of the upper and lower tray assemblies 2 and 3 in the horizontal plane (i.e., the width between the tray assemblies 2 and 3 leaning towards the user's bilateral cheeks) is 25 - 75 mm, and the longitudinal length (i.e., the length from one end of the tray assemblies 2 and 3 leaning towards the user's front teeth to the end leaning towards the user's temporomandibular joint) is 20 - 80 mm. The design of the projected area of the shapeable components 21 and 31 in the horizontal plane being larger than that of the brackets 22 and 32 is mainly for the following considerations: First, the shapeable components 21 and 31 are made of flexible materials, which are more likely to adapt to the oral cavity shape and reduce the irritation and scratching of the oral soft tissues. Second, due to the larger projected area of the shapeable components 21 and 31, the contact pressure on the oral soft tissues can be reduced, thus further reducing the risk of scratching. In addition, considering the differences in the distance 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 behind the molars, especially in this area near 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 in the horizontal plane is larger 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.

[0094] As Figure 5As shown, the deformable components 21 and 31 each have at least one groove. The deformable components 21 and 31 each have a first groove 211 and 311 for accommodating the user's teeth and are positioned at the central positions of the deformable components 21 and 31. In any cross-section perpendicular to the horizontal plane, the deformable components 21 and 31 each have at least a second groove 212 and 312, and the second grooves 212 and 312 are used to prevent the deformable components 21 and 31 from overflowing the defined range (the boundary of the oral appliance 1) during the heating and shaping process. The deformable components 21 and 31 are provided with the first grooves 211 and 311 and the second grooves 212 and 312, aiming to provide a better shaping effect during the heating and shaping process. During heating and shaping, the first grooves 211 and 311 are in contact with the user's teeth. When the user performs occlusal shaping, the periphery of the first grooves 211 and 311 is squeezed, and the excess material will move to the side away from the teeth respectively. Excessive material may overflow the boundary of the oral appliance 1, reducing the adaptability and wearing comfort of the oral appliance 1. The setting of the second grooves 212 and 312 effectively solves this problem. It is arranged on the moving path of the excess material. During the extrusion process, the excess material will automatically flow into the second grooves 212 and 312, thereby controlling the flow of the shaping material and preventing the excess material from overflowing the boundary of the oral appliance 1 during the shaping process.

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

[0096] Embodiment 1

[0097] The oral appliance 1 in this embodiment includes an upper tray assembly 2 and a lower tray assembly 3. Among them, the upper tray assembly 2 is configured to be positioned on the user's maxillary dentition; the lower tray assembly 3 is configured to be positioned on the user's mandibular dentition. The upper tray assembly 2 includes an upper deformable component 21 and an upper bracket 22, and the lower tray assembly 3 includes a lower deformable 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 deformable components 21 and 31 include the upper deformable component 21 and the lower deformable component 31.

[0098] Specifically, please refer to Figures 9 to 10 , the deformable components 21 and 31 each have at least one groove. The deformable components 21 and 31 have at least one first groove 211 and 311. The first grooves 211 and 311 include a front wall 2111 and a rear wall 2112, and the distance between the front wall 2111 and the rear wall 2112 is at least partially variable, and the range of the distance between the two is between 0.1 - 20 mm, that is Figure 9 , Figure 12the distance shown as d1 in []. The projected area of the first grooves 211 and 311 on the horizontal plane accounts for 10-90% of the projected area of the shapeable components 21 and 31 on the horizontal plane. This design is because it is considered that different teeth of users have different sizes. For example, the central incisor part is usually narrower and thinner, suitable for cutting and tearing food; the molar part is usually wider and thicker, more suitable for chewing and grinding food. Secondly, there are also differences between the maxillary dentition and the mandibular dentition. The central incisor part of the maxillary dentition is usually longer and larger than that of the mandibular dentition. Therefore, as Figures 9 to 12 shown, the distance between the front wall 2111 and the rear wall 2112 of the first groove is adjusted accordingly, that is, the width in the middle of the first grooves 211 and 311 (the position of the central incisor, as Figure 9 shown) is smaller than the width on both sides of the first grooves 211 and 311 (the position of the molar, as Figure 12 shown), and the height in the middle of the first grooves 211 and 311 (the position of the central incisor, as Figure 9 shown) is greater than the height on both sides of the first grooves 211 and 311 (the position of the molar, as Figure 12 shown). The first grooves 211 and 311 further include a bottom wall 2113. The vertical distance between the bottom wall 2113 and the brackets 22 and 32 ranges from 1 to 15 mm. The vertical distance between the two is the Figure 9 , Figure 12 distance shown as d3 in []. Also considering that different teeth of users have different sizes, the vertical distance between the bottom wall 2113 and the brackets 22 and 32 is adjusted accordingly, that is, the vertical distance between the middle of the first grooves 211 and 311 (the position of the central incisor, as Figure 9 shown) from the brackets 22 and 32 is greater than the vertical distance between both sides of the first grooves 211 and 311 (the position of the molar, as Figure 12 shown) from the brackets 22 and 32. Among them, preferably, the vertical distance between the middle of the first grooves 211 and 311 from the brackets 22 and 32 is 4-6 mm, and the vertical distance between both sides of the first grooves 211 and 311 from the brackets 22 and 32 is 1-3 mm.

[0099] The shapeable components 21 and 31 have at least one second groove 212 and 312 in any cross-section perpendicular to the horizontal plane. The second grooves 212 and 312 include a bottom wall 2123, a front wall 2121, and a rear wall 2122. The distance between the front wall 2121 and the rear wall 2122 ranges from 0.1 to 10 mm. The distance between the two is the Figure 13 distance shown as d2 in []. The vertical distance between the bottom wall 2123 and the brackets 22 and 32 ranges from 0.5 to 15 mm. The vertical distance between the two is d4 in Figure 13 [].

[0100] Due to the different characteristics of the materials and the sizes of the teeth, the second grooves 212 and 312 may be distributed at different positions. In other embodiments, such as Figure 14 shown, the second grooves 212 and 312 may be distributed in front of and behind the first grooves 211 and 311, or may only be distributed in front of the first grooves 211 and 311 or behind the first grooves 211 and 311, or may be intermittently distributed in different regions.

[0101] 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.

[0102] The moldable oral appliance 1 of the present utility model has at least the following beneficial effects:

[0103] 1) The moldable components 21 and 31 are made of flexible thermoplastic materials and have good adaptability, capable of effectively adapting to the shape of the user's oral cavity. The design of the moldable components 21 and 31 covers most areas of the oral appliance 1, especially the parts that are prone to scratching. This design effectively reduces the friction between the oral appliance 1 and the oral tissues, thus making the user feel more comfortable during wearing.

[0104] 2) The moldable components 21 and 31 are provided with the first grooves 211 and 311 and the second grooves 212 and 312, aiming to provide a better shaping effect during the heating and shaping process. During heating and shaping, the first grooves 211 and 311 are used to accommodate the user's teeth. When the user performs bite shaping, the shaping materials on the front wall 2111 and the rear wall 2112 of the first groove are squeezed, and the excess materials will move to the side away from the teeth respectively. The excess materials may overflow from the boundary of the oral appliance, thus reducing the adaptability and wearing comfort of the appliance. The setting of the second grooves 212 and 312 effectively solves this problem. It is arranged on the moving path of the excess materials. During the extrusion process, the excess materials will automatically flow into the second grooves 212 and 312, thereby controlling the flow of the shaping materials and avoiding the overflow of the excess materials during the shaping process. This design not only improves the fitting degree and comfort of the oral appliance 1, but also reduces the waste of materials, bringing a better use experience to the user. At the same time, this design also makes the oral appliance 1 more economical and environmentally friendly during the production process.

[0105] 3) The shapeable components 21 and 31 each have a first groove 211 and 311, which are disposed at the central positions of the shapeable components 21 and 31 and are used to accommodate the user's teeth. Considering the differences in the sizes of different teeth, the distance between the front wall 2111 and the rear wall 2112 of the groove is adjusted accordingly. The central incisor part is usually narrower and thinner, suitable for cutting and tearing food; the molar part is usually wider and thicker, more suitable for chewing and grinding food. In addition, there are also differences between the upper dental arch and the lower dental arch. Therefore, the sizes of the first grooves 211 and 311 are set to adapt to the shapes of different teeth: for example, the width in the middle (central incisor position) is smaller than that on both sides (molar position), and the height in the middle (central incisor position) is greater than that on both sides (molar position). This design helps the oral appliance 1 to better fit the user's teeth, making it easier and more accurate for the user to shape the oral appliance 1.

[0106] 4) The heights of the shapeable components 21 and 31 are different at different positions. This design takes into account the curved characteristics of the oral structure, so height differences are set in their shapes. At the same time, the overall shapes of the tray assemblies 2 and 3 also consider the curved characteristics of the oral structure and height differences are also set. As part of the tray assemblies 2 and 3, the overall shapes of the shapeable components 21 and 31 correspondingly adapt to the height differences of the tray assemblies 2 and 3 to ensure that the oral appliance 1 fits better with the user's teeth and oral structure, providing better comfort and user experience. When the user bites, the shapeable components 21 and 31 can form closer contact with the teeth and oral structure, effectively improving the fitting degree of the oral appliance 1. At the same time, this design makes it more convenient for the user to bite. This design not only improves the adaptability and fitting degree of the oral appliance 1, but also improves the comfort of the user when wearing the oral appliance 1, thus improving the treatment effect and user experience.

[0107] 5) The shapeable components 21 and 31 are made of flexible materials. Compared with the brackets 22 and 32, they are more likely to adapt to the oral cavity morphology and reduce the irritation and scratching of the oral soft tissues. Therefore, the horizontal plane projection area of the shapeable components 21 and 31 is set to be larger than that of the brackets 22 and 32, which can reduce the contact pressure of the oral appliance 1 on the oral soft tissues and further reduce 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, the oral appliance 1 of the present utility model is designed to allow the user to adjust the length by trimming to adapt to this distance. The soft shapeable components 21 and 31 enable the user to easily trim 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 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 of the oral appliance 1.

[0108] 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 various 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 to be within the scope described in this specification.

[0109] The above-described embodiments only express 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. A malleable oral appliance, characterized in that, Comprising: An upper tray assembly configured to be positioned over a user's maxillary dentition; A lower tray assembly configured to be positioned over a user's mandibular dentition; 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 and the lower shapeable member each have at least one groove; The groove includes a first groove having a front wall and a rear wall, and the distance between the front wall and the rear wall is at least partially variable.

2. The oral appliance according to claim 1, wherein The materials of the upper shapeable member and the lower shapeable member are medical-grade shapeable materials.

3. The oral appliance according to claim 1, wherein The upper shapeable member and the lower shapeable member will not damage their materials or properties during the deformation process.

4. The oral appliance according to claim 1, wherein The upper shapeable member and the lower shapeable member allow for minor deformation while maintaining the deformed shape.

5. The oral appliance according to claim 1, characterized in that, The width in the middle of the first groove is smaller than the widths on both sides of the first groove.

6. The oral appliance according to claim 1, wherein The height in the middle of the first groove is greater than the heights on both sides of the first groove.

7. A malleable oral appliance, characterized in that, Comprising: An upper tray assembly configured to be positioned over a user's maxillary dentition; A lower tray assembly configured to be positioned over a user's mandibular dentition; 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 and the lower shapeable member each have a first groove; In any cross-section perpendicular to the horizontal plane, the upper shapeable member and the lower shapeable member each have at least a second groove at least partially, and the second groove is configured to prevent the upper shapeable member and the lower shapeable member from overflowing the defined range during the heating and shaping process.

8. The oral appliance according to claim 7, wherein The upper shapeable member and the lower shapeable member are at least partially made of a flexible thermoplastic material.

9. The oral appliance according to claim 7, wherein The upper bracket and the lower bracket are at least partially made of a material that is relatively rigid compared to the upper shapeable member and the lower shapeable member to ensure the structural stability and support of the oral appliance.

10. The oral appliance according to claim 7, wherein The first groove is for accommodating the user's teeth.

11. The oral appliance according to claim 7, wherein, The upper shapeable member and the lower shapeable member do not produce harmful substances or odors during the heating and shaping process.

12. A moldable oral appliance, characterized in that, Comprising: An upper tray assembly configured to be positioned over a user's maxillary dentition; A lower tray assembly configured to be positioned over a user's mandibular dentition; 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 plastically deformable component and the lower plastically deformable component each have at least one groove; The projected area of the upper plastically deformable component on the horizontal plane is greater than the projected area of the upper bracket on the horizontal plane; The projected area of the lower plastically deformable component on the horizontal plane is greater than the projected area of the lower bracket on the horizontal plane.

13. The oral appliance according to claim 12, wherein, The height of the upper plastically deformable component and the lower plastically deformable component is at least partially 0.5 - 30 mm.

14. The oral appliance according to claim 12, wherein The upper bracket and the lower bracket each have an outer wall, and the upper plastically deformable component and the lower plastically deformable component at least partially cover the top of the outer wall.

15. The oral appliance according to claim 14, wherein, The height at which the upper plastically deformable component and the lower plastically deformable component cover the top of the outer wall is 0 - 30 mm.

16. The oral appliance according to claim 14, wherein, The width at which the upper plastically deformable component and the lower plastically deformable component cover the top of the outer wall is 0 - 10 mm.

17. A malleable oral appliance, characterized in that, Comprising: An upper tray assembly configured to be positioned in the user's maxillary dentition; A lower tray assembly configured to be positioned in the user's mandibular dentition; The upper tray assembly includes an upper plastically deformable component and an upper bracket; The lower tray assembly includes a lower plastically deformable component and a lower bracket; Wherein, the upper plastically deformable component and the lower plastically deformable component are made of a plastic 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 upper plastically deformable component and the lower plastically deformable component to deform; The upper plastically deformable component and the lower plastically deformable component each have a first groove; The upper plastically deformable component and the lower plastically deformable component each have a second groove; The upper plastically deformable component and the lower plastically deformable component have one or more of the following characteristics: The first groove has a bottom wall, and the vertical distance between the bottom wall and the upper bracket and / or the lower bracket ranges from 1 to 15 mm; The second groove has a bottom wall, and the vertical distance between the bottom wall and the upper bracket and / or the lower bracket ranges from 0.5 to 15 mm; The projected area of the first groove on the horizontal plane occupies a proportion of 10 - 90% of the projected area of the upper plastically deformable component and / or the lower plastically deformable component on the horizontal plane.

18. The oral appliance according to claim 17, wherein, The second groove has a front wall and a rear wall, and the distance between the front wall and the rear wall ranges from 0.1 to 10 mm.

19. The oral appliance according to claim 17, wherein, The height in the middle of the upper plastically deformable component is greater than the height at both ends of the upper plastically deformable component, and the height in the middle of the lower plastically deformable component is greater than the height at both ends of the lower plastically deformable component.

20. The oral appliance according to claim 17, wherein, The shape of the upper tray assembly is configured as an arched structure that conforms to the curve of the user's upper dentition.

21. The oral appliance according to claim 18, wherein, The shape of the lower tray assembly is configured as an arched structure that conforms to the curve of the user's lower dentition.

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