Moldable oral appliance

Abstract

The invention 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 present invention relates to oral appliances, and in particular to a device for preventing, reducing or eliminating snoring and / or obstructive sleep apnea. BACKGROUND

[0002] In modern medicine, sleep problems have become a health area of concern. Snoring and obstructive sleep apnea are two common sleep disorders that not only affect the quality of patients' sleep, but also can cause a series of health problems. At the same time, the technology in the field of oral appliances is also developing, providing new treatment options for solving these sleep problems.

[0003] Snoring is a noise caused by airflow obstruction in the throat due to relaxation of the tissues during sleep. During sleep, the tongue and soft palate may collapse, causing the airway to narrow, causing vibration when air passes through, producing the irritating sound of snoring. This phenomenon not only disturbs the patient's own sleep, but also affects the sleep of their roommates or family members. Obstructive sleep apnea is more serious, which is caused by partial or complete obstruction of the throat, causing airflow to stop, resulting in respiratory arrest. This can cause repeated respiratory arrest in patients during sleep, severely affecting oxygen supply, which can lead to a decrease in blood oxygen levels, and further damage to the cardiovascular system and brain.

[0004] In order to solve sleep problems such as snoring and obstructive sleep apnea, there are currently a variety of prevention and treatment methods available. Oral appliances are considered to be one of the effective options. One of the common oral appliances is the mandibular advancement device (MAD). This device pushes the mandible relative to the maxilla to increase the airflow in the throat passage, thereby reducing or eliminating the occurrence of snoring and obstructive sleep apnea. In addition to MAD, tongue retaining devices (TRD) and tongue stabilizing devices (TSD) are also common oral appliances that support the position of the tongue to maintain the patency of the throat and reduce the occurrence of sleep apnea.

[0005] In addition to traditional oral appliances, advances in modern technology have also brought new options for the treatment of sleep disorders. Smart oral appliances combine sensor technology and data analysis to monitor users' sleep in real time and adjust the use of the appliance as needed, providing personalized treatment plans. In addition, the application of 3D printing technology also provides a more accurate method for the customization of oral appliances, making the appliance more fitted to the user's oral morphology, improving comfort and treatment effectiveness.

[0006] Despite the continuous advancement in the field of oral appliances, there are still challenges faced by users. Some users can feel uncomfortable with the use of the appliance, which can affect the treatment outcome; other users can experience discomfort or bite problems during use. In addition, the cost of using the appliance is a factor for users to consider whether to continue using the appliance. SUMMARY

[0007] Therefore, in view of the above, there is provided an effective, comfortable and cost-effective shapeable oral appliance.

[0008] A shapeable oral appliance, comprising:

[0009] an upper tray assembly configured to be positioned on a user's upper dentition;

[0010] a lower tray assembly configured to be positioned on a user's lower dentition;

[0011] the upper tray assembly comprises an upper shapeable component and an upper support;

[0012] the lower tray assembly comprises a lower shapeable component and a lower support;

[0013] wherein the upper shapeable component and the lower shapeable component are made of a material having plasticity and can be deformed when heated, and the upper support and the lower support do not deform when heated to a temperature required for the upper shapeable component and the lower shapeable component to deform;

[0014] the upper shapeable component and the lower shapeable component each have at least one groove;

[0015] the groove comprises 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.

[0016] In one embodiment, the material of the upper shapeable component and the lower shapeable component is a medical grade plastic material.

[0017] In one embodiment, the upper shapeable component and the lower shapeable component do not damage their material or performance during deformation.

[0018] In one embodiment, the upper shapeable component and the lower shapeable component allow for slight deformation while maintaining the shape after deformation.

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

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

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

[0022] an upper tray assembly configured to be positioned on a user's upper dentition;

[0023] a lower tray assembly configured to be positioned on a user's lower dentition;

[0024] the upper tray assembly comprises an upper shapeable component and an upper support;

[0025] the lower tray assembly comprises a lower shapeable component and a lower support;

[0026] wherein the upper shapeable component and the lower shapeable component are made of a material with shapeability and can be deformed when heated, and the upper support and the lower support do not deform when heated to a temperature required for the upper shapeable component and the lower shapeable component to deform;

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

[0028] the upper shapeable component and the lower shapeable component each have at least partially a second groove in any cross section perpendicular to a horizontal plane, and the second groove is configured to prevent the upper shapeable component and the lower shapeable component from overflowing a defined range during the process of being heated and shaped.

[0029] In one embodiment, the upper shapeable component and the lower shapeable component are at least partially made of a flexible thermoplastic material.

[0030] In one embodiment, the upper support and the lower support are at least partially made of a material that is relatively rigid compared to the upper shapeable component and the lower shapeable component, so as to ensure the structural stability and support of the oral appliance.

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

[0032] In one embodiment, the upper shapeable component and the lower shapeable component do not produce harmful substances or odors during the process of being heated and shaped.

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

[0034] an upper tray assembly configured to be positioned on a user's upper dentition;

[0035] a lower tray assembly configured to be positioned on a user's lower dentition;

[0036] the upper tray assembly comprises an upper shapeable component and an upper support;

[0037] The lower tray assembly comprises a lower moldable component and a lower support;

[0038] The upper moldable component and the lower moldable component are made of a material with moldability and can be deformed when heated, and the upper support and the lower support do not deform when heated to a temperature required for the upper moldable component and the lower moldable component to deform;

[0039] The upper moldable component and the lower moldable component each have at least one groove;

[0040] The projected area of the upper moldable component on a horizontal plane is greater than the projected area of the upper support on the horizontal plane;

[0041] The projected area of the lower moldable component on a horizontal plane is greater than the projected area of the lower support on the horizontal plane.

[0042] In one embodiment, the height of the upper moldable component and the lower moldable component is at least partially 0.5-30mm.

[0043] In one embodiment, the upper support and the lower support each have an outer wall, and the upper moldable component and the lower moldable component at least partially cover the top of the outer wall.

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

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

[0046] The present application also discloses a moldable oral appliance, comprising:

[0047] The upper tray assembly is configured to be positioned on the upper dentition of the user;

[0048] The lower tray assembly is configured to be positioned on the lower dentition of the user;

[0049] The upper tray assembly comprises an upper moldable component and an upper support;

[0050] The lower tray assembly comprises a lower moldable component and a lower support;

[0051] The upper moldable component and the lower moldable component are made of a material with moldability and can be deformed when heated, and the upper support and the lower support do not deform when heated to a temperature required for the upper moldable component and the lower moldable component to deform;

[0052] The upper moldable component and the lower moldable component each have a first groove;

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

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

[0055] The first groove has a bottom wall, and the vertical distance between the bottom wall and the upper and / or lower support is in the range of 1-15 mm;

[0056] The second groove has a bottom wall, and the vertical distance between the bottom wall and the upper and / or lower support is in the range of 0.5-15 mm;

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

[0058] In one embodiment, the second groove has a front wall and a back wall, and the distance between the front wall and the back wall is in the range of 0.1-10 mm.

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

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

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

[0062] The shapeable oral appliance according to the present application has at least the following advantages:

[0063] 1) The shapeable component is made of a flexible thermoplastic material, which has good adaptability and can effectively adapt to the morphology of the user's oral cavity. The design of the shapeable component covers most of the area of the oral appliance, especially the parts that are prone to scratching. This design effectively reduces the friction between the oral appliance and the oral tissue, making the user feel more comfortable during wear.

[0064] 2) The first and second grooves are designed to provide a better shaping effect during the heating shaping process. During the heating shaping process, the first groove is used to accommodate the user's teeth. When the user performs the occlusal shaping, the shaping material on the front and back walls of the first groove is extruded, and the excess material moves to the side away from the teeth, respectively. The excess material may overflow the boundary of the oral appliance, thereby reducing the adaptability and wearing comfort of the appliance. The second groove effectively solves this problem. It is arranged on the path of the excess material and 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 the excess material during the shaping process. This design not only improves the fit and comfort of the oral appliance, but also reduces material waste, providing a better user experience. At the same time, this design also makes the production of oral appliances more economical and environmentally friendly.

[0065] 3) The first groove is arranged in the center of the shapeable component and is used to accommodate the user's teeth. Considering the difference in size of different teeth, the distance between the front and back walls of the groove is adjusted accordingly. The central incisor part is usually narrow and thin, suitable for cutting and tearing food; the molar part is usually wide and thick, more suitable for chewing and grinding food. In addition, there are differences between the upper and lower dental arches. Therefore, the size of the first groove is set to adapt to the shape of different teeth: the width of the middle (central incisor position) is smaller than that of the two sides (molar position), and the height of the middle (central incisor position) is greater than that of the two 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 curved characteristics of the oral structure, so the overall shape of the shapeable component has a height difference. At the same time, the overall shape of the tray assembly also takes into account the curved characteristics of the oral structure, also with a height difference. As part of the tray assembly, the overall shape of the shapeable component is adapted to the height difference 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 the 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 easier for the user to occlude. 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 malleable component is made of flexible material, which, compared to the framework, more easily adapts to the oral cavity shape, reducing irritation and scratches to the oral soft tissues. Therefore, setting the horizontal projection area of ​​the malleable component to be larger than that of the framework can reduce the contact pressure of the oral appliance on the oral soft tissues, further reducing the risk of scratches. Furthermore, considering the differences in the distance from the inner lip to the retromolar region among different users, the oral appliance design of this invention allows users to adjust the length to fit this distance through trimming. The soft, malleable component allows users to easily trim it and adjust the length of the device according to individual needs, thereby improving comfort and personalized adaptability. It is worth noting that, because the horizontal projection area of ​​the malleable component is larger than that of the framework, trimming does not affect the structure and function of the framework, thus ensuring the stability of the oral appliance. Attached Figure Description

[0068] Figure 1 This is a schematic diagram of the overall structure of the oral appliance in one embodiment of the present invention;

[0069] Figure 2 These are exploded structural diagrams of oral appliances in several embodiments of the present invention;

[0070] Figure 3 This is a schematic diagram of the horizontal plane, sagittal plane, and coronal plane in several embodiments of the present invention;

[0071] Figure 4 This is a top view of the upper tray assembly in one embodiment of the present invention;

[0072] Figure 5 In one embodiment of the present invention, the upper tray assembly is in Figure 4 Cross-sectional view along the AA direction;

[0073] Figure 6 In one embodiment of the present invention, the upper tray assembly is in Figure 4 Cross-sectional view in the middle BB direction;

[0074] Figure 7 This is a schematic diagram of the horizontal projection plane of the upper malleable component and the upper support in one embodiment of the present invention;

[0075] Figure 8 This is a side view of the upper tray assembly in one embodiment of the present invention;

[0076] Figure 9 This is a partial cross-sectional view of the upper tray assembly in Embodiment 1 of the present invention;

[0077] Figure 10 This is a schematic diagram of the area of ​​the first groove of the malleable component on a horizontal plane in Embodiment 1 of the present invention;

[0078] Figure 11 Fig. 2 is a schematic view of the position of the upper dentition in the upper tray assembly of embodiment one of the present application;

[0079] Figure 12 Fig. 3 is a partial cross-sectional view of the first recess in the upper tray assembly of embodiment one of the present application;

[0080] Figure 13 Fig. 4 is a partial cross-sectional view of the second recess in the upper tray assembly of embodiment one of the present application;

[0081] Figure 14 Fig. 5 is a schematic view of the distribution of the second recess in the shapeable component of embodiment one of the present application. DETAILED DESCRIPTION

[0082] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a large number of other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0083] The present application relates to oral appliances 1, and in particular to a device for preventing, reducing or eliminating snoring and / or obstructive sleep apnea. In some embodiments, the appliance can also function as a mouth guard for the upper dentition, lower dentition or both dentitions for sports. In some embodiments, the appliance can also function as a mouth guard for the upper dentition, lower dentition or both dentitions for grinding teeth.

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

[0085] In particular, referring to Figures 1 to 3 The oral appliance 1 of the present application comprises an upper tray assembly 2 configured to be positioned on the upper dentition of a user, and a lower tray assembly 3 configured to be positioned on the lower dentition of a user. The tray assemblies 2, 3 are designed to match the shape and structure of the dentition of the user, and can provide sufficient support and stability to the oral appliance 1, and therefore the upper and lower tray assemblies 2, 3 are configured in an arched structure that follows the curvature of the dentition of the user, so as to better fit the upper and lower teeth of the user.

[0086] The upper tray assembly 2 comprises an upper moldable part 21 and an upper holder 22, and the lower tray assembly 3 comprises a lower moldable part 31 and a lower holder 32. In the present invention, the tray assemblies 2, 3 comprise the upper tray assembly 2 and the lower tray assembly 3, the holders 22, 23 comprise the upper holder 22 and the lower holder 32, and the moldable parts 21, 31 comprise the upper moldable part 21 and the lower moldable part 31. The materials for the upper tray assembly 2 and the lower tray assembly 3 can be selected from a wide range of materials, and plastics or polymer materials suitable for oral medical devices and can be molded can be used. These materials include, but are not limited to, polypropylene (PP), polycarbonate (PC), polyethylene terephthalate (PET), polymethyl acrylate (PMMA), polyphenylsulfone (PPSU), polyethylene (PE), high-density polyethylene (HDPE), low-density polyethylene (LDPE), ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane (TPU), styrene-ethylene-butylene-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. The various parts of the upper tray assembly 2 and the lower tray assembly 3, such as the moldable parts 21, 31 and the holders 22, 32, can be made of a single material or a combination of multiple materials. The design of such a multi-material combination can take full advantage of the properties of different materials to meet various needs of the oral appliance 1 during use. A multi-layer structure can also be used, and the materials of each layer can be the same or different. This design can optimize the configuration of material properties. The polymer materials can contain various fillers, plasticizers, pigments and other additives to meet different performance requirements and manufacturing needs. For example, nanoscale fillers can be added to enhance the strength and hardness of the material, or antibacterial agents can be added to improve the hygiene performance of the oral appliance. Suitable types of polymer materials include thermoplastic plastics, thermosetting polymers, elastomers and thermoplastic elastomers. These materials can be copolymers, terpolymers, or mixtures of different types of polymers, such as mixtures of thermoplastic plastics with different molecular weights. These materials have good processing properties and mechanical properties, and are suitable for the manufacture of the oral appliance 1.

[0087] The upper and lower moldable parts 21, 31 are made of a material with moldability, preferably using thermoplastic, so that the user can complete the adaptive adjustment of the oral appliance 1 by self-heating and molding. Among them, the heating and molding method adopts the method of "boiling bite", which is a simple and easy method. The user only needs to heat the oral appliance 1 in hot water, and then bite the oral appliance 1 with the mouth to make it fit the user's teeth and then mold. The upper and lower moldable parts 21, 31 are made of a material with moldability, which can be deformed when heated, and the upper and lower supports 22, 32 do not deform when heated to the temperature required for the upper and lower moldable parts 21, 31 to deform. This design ensures the stability and reliability of the oral appliance 1 during the molding process, allowing the user to easily complete the adaptive adjustment and achieve a better user experience.

[0088] It is worth noting that if the supports 22, 32 also use thermoplastic, their deformation temperature will be higher than that of the moldable parts 21, 31, which can ensure that the supports 22, 32 are not affected during the heating and molding process. In addition, since the different parts of the oral appliance 1 have different functions, attention should be paid to not affecting the original function during the heating and molding process. By keeping the stability and shape of the supports 22, 32 unchanged, even when the moldable parts 21, 31 are being molded, the basic functions of the oral appliance 1 can be ensured not to be affected. This design takes into account the characteristics of different parts, ensuring the smooth progress of the entire heating and molding process, as well as the reliability and stability of the final result.

[0089] In addition, the upper and lower moldable parts 21, 31 have several requirements in terms of material selection. First, medical-grade moldable materials are used, which meet medical-grade standards to ensure the safety and reliability of the oral appliance 1. Second, the moldable parts 21, 31 do not damage their materials or properties during the deformation process. This means that during the heating and molding process, the material 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 moldable parts 21, 31 do not produce harmful substances or odors during the heating and molding process to ensure the safety and comfort of the user. Finally, the moldable parts 21, 31 allow for slight deformation while maintaining the shape after deformation. The moldable parts 21, 31 are at least partially made of flexible thermoplastic material, which is shaped after heating and molding to fit the shape of the teeth and maintain the shape after molding. In addition, due to the characteristics of the flexible thermoplastic material used, during wear, if the user applies biting force, the material will exhibit a certain degree of elasticity and toughness, allowing the moldable parts 21, 31 to produce slight deformation when adapting to the force of the teeth bite. This deformation does not cause the shape after molding to change completely, but makes the wear more comfortable, while ensuring the stability and adaptability of the moldable parts 21, 31.

[0090] The height of the shapeable components 21, 31 varies at different positions, as shown in Figure 5 、 Figure 6 The height of the shapeable components 21, 31 is 0.5-30mm in total, and the height in the middle (the position of the central incisors, as shown in Figure 5 ) is greater than the height at both ends (the position of the molars, as shown in Figure 6 ). This design takes into account the curved nature of the oral structure, so the height difference is set in its shape. At the same time, the overall shape of the upper tray assembly 2 and the lower tray assembly 3 also takes into account the curved nature of the oral structure, and also sets a height difference. As part of the upper tray assembly 2 and the lower tray assembly 3, the overall shape of the shapeable components 21, 31 is adapted accordingly to the height difference of the upper tray assembly 2 and the lower tray assembly 3, to ensure that the oral appliance 1 fits the user's teeth and oral structure more closely, providing better comfort and use experience. When the user bites, the shapeable components 21, 31 can form a closer contact with the teeth and oral structure, effectively improving the fit of the oral appliance 1. At the same time, this design makes it easier for the user to bite. This design not only improves the adaptability and fit of the oral appliance 1, but also improves the comfort of the user when wearing the oral appliance 1, thereby improving the treatment effect and user experience.

[0091] The supports 22, 32 are at least partially made of a material that is relatively rigid compared to the shapeable components 21, 31, to ensure the structural stability and support of the oral appliance 1, which is to provide the stability and support required by the oral appliance 1. The rigid design of the supports 22, 32 ensures that the oral appliance 1 does not deform or loosen during use, maintaining its stability and functionality. This design not only maintains the overall structural stability of the oral appliance 1, but also provides sufficient support, so that the user can comfortably use the oral appliance 1.

[0092] As shown in Figure 4 and Figure 5 , the supports 22, 32 have an outer wall 221. When wearing the oral appliance 1, the top of the upper and lower parts is the part that is most likely to contact the inside of the oral cavity, and if the top is covered by a relatively rigid support, it is easy to cause scratches. Therefore, in the present application, the top 2211 of the outer wall 221 of the support is at least partially covered by the shapeable components 21, 31, and the width of the top 2211 of the outer wall 221 of the support covered by the shapeable components 21, 31 is 0-10mm, i.e. w1 in Figure 5 , and the height of the top 2211 of the outer wall 221 of the support covered by the shapeable components 21, 31 is 0-30mm, i.e. Figure 5h1. The shapeable components 21, 31 are made of flexible thermoplastic material, which has good adaptability and can effectively adapt to the morphology of the user's oral cavity. The design covers most of the area of the oral appliance 1 in contact with the oral cavity, especially the area prone to scratching. This design effectively reduces the friction between the oral appliance 1 and the oral tissue, making the user feel more comfortable during wear.

[0093] As shown in Figure 7 , Figure 8 , the projection area of the upper shapeable component 21 on the horizontal plane (i.e., the plane perpendicular to the sagittal plane and the coronal plane) is greater than the projection area of the upper bracket 22 on the horizontal plane, and the projection area of the lower shapeable component 31 on the horizontal plane is greater than the projection area of the lower bracket 32 on the horizontal plane. The transverse width (i.e., the width between the two sides of the user's cheeks) of the upper and lower tray assemblies 2, 3 on the horizontal plane is 25-75 mm, and the longitudinal length (i.e., the length from the end of the user's front teeth to the end of the user's temporomandibular joint) is 20-80 mm. The horizontal projection area of the shapeable components 21, 31 is designed to be larger than the brackets 22, 32, mainly for the following considerations: first, the shapeable components 21, 31 are made of flexible material, which is more adaptable to the oral morphology and reduces the irritation and scratching of the oral soft tissue. Second, since the projection area of the shapeable components 21, 31 is larger, the contact pressure on the oral soft tissue can be reduced, thereby further reducing the risk of scratching. In addition, considering the difference in the distance from the inner lip to the posterior region of the molar of different users, an excessively long device can cause scratching of the oral tissue in the posterior region of the molar, especially in the area located at the joint, and an ill-fitting device can affect the occlusal function. The design of the oral appliance 1 in this embodiment allows the user to adjust the length by trimming to adapt to the distance from the inner lip to the posterior region of the molar, and the soft shapeable components 21, 31 allow the user to easily trim and independently adjust the length of the device according to individual needs, improving the comfort and personalized adaptability of use. It should be emphasized that the shapeable components 21, 31 have a larger horizontal projection area than the brackets 22, 32, so that the brackets 22, 32 are not affected when trimming, thereby 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 to adjust, making the use of the oral appliance 1 more comfortable.

[0094] As shown in Figure 5As shown, the shapeable parts 21, 31 each have at least one groove. The shapeable parts 21, 31 each have a first groove 211, 311 for accommodating the user's teeth and setting their positions at the center of the shapeable parts 21, 31. The shapeable parts 21, 31 each have at least partially a second groove 212, 312 in any cross section perpendicular to the horizontal plane, the second groove 212, 312 being used to prevent the shapeable parts 21, 31 from overflowing the defined range (the boundary of the oral appliance 1) during the heat molding process. The shapeable parts 21, 31 are provided with the first groove 211, 311 and the second groove 212, 312, aiming to provide a better molding effect during the heat molding process. During the heat molding, the first groove 211, 311 is in contact with the user's teeth, and when the user performs the bite molding, the periphery of the first groove 211, 311 is pressed, and the excess material will move away from the teeth, respectively. The excess material can overflow the boundary of the oral appliance 1, reducing the adaptability and wearing comfort of the oral appliance 1. The second groove 212, 312 effectively solves this problem, which is arranged on the path of the excess material, and during the pressing process, the excess material will automatically flow into the second groove 212, 312, thereby controlling the flow of the molding material and avoiding the overflow of the boundary of the oral appliance 1 during the molding process.

[0095] The following describes several structures of the oral appliance 1 according to specific examples.

[0096] Example 1

[0097] The oral appliance 1 in this example includes an upper tray assembly 2 and a lower tray assembly 3, wherein the upper tray assembly 2 is configured to be positioned on the user's upper dentition; the lower tray assembly 3 is configured to be positioned on the user's lower dentition. The upper tray assembly 2 includes an upper shapeable part 21 and an upper bracket 22, and the lower tray assembly 3 includes a lower shapeable part 31 and a lower bracket 32. In this example, the brackets 22, 23 include the upper bracket 22 and the lower bracket 32, and the shapeable parts 21, 31 include the upper shapeable part 21 and the lower shapeable part 31.

[0098] Specifically, please refer to Figures 9 to 10 The shapeable parts 21, 31 each have at least one groove. The shapeable parts 21, 31 have at least one first groove 211, 311. The first groove 211, 311 includes 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 distance therebetween ranges from 0.1-20mm, i.e. Figure 9 、 Figure 12The projection area of the first groove 211, 311 in the horizontal plane accounts for 10-90% of the projection area of the shapeable part 21, 31 in the horizontal plane. This design is because different teeth of different users have different sizes. For example, the central incisor part is usually narrow and thin, which is suitable for cutting and tearing food; the molar part is usually wide and thick, which is more suitable for chewing and grinding food. Secondly, there are differences between the upper and lower teeth. The central incisor part of the upper teeth is usually longer and larger than that of the lower teeth. Therefore, as shown in Figures 9 to 12 , the distance between the front wall 2111 and the back wall 2112 of the first groove is adjusted accordingly, that is, the width of the first groove 211, 311 in the middle (central incisor position, as shown in Figure 9 ) is smaller than that on both sides (molar position, as shown in Figure 12 ), and the height of the first groove 211, 311 in the middle (central incisor position, as shown in Figure 9 ) is greater than that on both sides (molar position, as shown in Figure 12 ). The first groove 211, 311 also includes a bottom wall 2113, and the vertical distance between the bottom wall 2113 and the bracket 22, 32 is in the range of 1-15mm, that is, the distance between the two is shown in Figure 9 , Figure 12 . Also considering that different teeth of different users have different sizes, the vertical distance between the bottom wall 2113 and the bracket 22, 32 is also adjusted accordingly, that is, the vertical distance between the first groove 211, 311 in the middle (central incisor position, as shown in Figure 9 ) and the bracket 22, 32 is greater than that on both sides (molar position, as shown in Figure 12 ) and the bracket 22, 32. Among them, preferably, the vertical distance between the first groove 211, 311 in the middle and the bracket 22, 32 is 4-6mm, and the vertical distance between the first groove 211, 311 on both sides and the bracket 22, 32 is 1-3mm.

[0099] The shapeable part 21, 31 has at least one second groove 212, 312 in any cross section perpendicular to the horizontal plane. The second groove 212, 312 includes a bottom wall 2123, a front wall 2121 and a back wall 2122, and the distance between the front wall 2121 and the back wall 2122 is in the range of 0.1-10mm, that is, the distance between the two is shown in Figure 13 . The vertical distance between the bottom wall 2123 and the bracket 22, 32 is in the range of 0.5-15mm, that is, the vertical distance between the two is shown in Figure 13 .

[0100] Due to the characteristics of the material and the size of the teeth, the second grooves 212, 312 can be distributed in different positions. In other embodiments, as shown in Figure 14 the first grooves 211, 311, or only in front of the first grooves 211, 311, or behind the first grooves 211, 311, or intermittently in different areas.

[0101] In addition, the technical features in each of the above embodiments can be combined as needed to obtain an oral appliance 1 comprising all or part of the above technical features.

[0102] The pliable oral appliance 1 according to the present application has at least the following advantages:

[0103] 1) The pliable component 21, 31 is made of a flexible thermoplastic material, which has good adaptability and can effectively adapt to the shape of the user's oral cavity. The pliable component 21, 31 is designed to cover most of the area 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 tissue, making the user feel more comfortable during wear.

[0104] 2) The pliable component 21, 31 is provided with first grooves 211, 311 and second grooves 212, 312, which are designed to provide better shaping effect during heat shaping. During heat shaping, the first grooves 211, 311 are used to accommodate the user's teeth, and when the user performs bite shaping, the shaping material of the front wall 2111 and the rear wall 2112 of the first grooves is extruded, and the excess material will move away from the teeth, respectively. The excess material may overflow the boundary of the oral appliance, thereby reducing the adaptability and wearing comfort of the appliance. The second grooves 212, 312 are provided to effectively solve this problem, which are arranged on the path of the excess material. During extrusion, the excess material will automatically flow into the second grooves 212, 312, thereby controlling the flow of the shaping material and avoiding the overflow of the excess material during shaping. This design not only improves the fit and comfort of the oral appliance 1, but also reduces material waste, providing a better user experience. At the same time, this design also makes the oral appliance 1 more economical and environmentally friendly in the production process.

[0105] 3) The shapeable parts 21, 31 each have a first groove 211, 311, which is arranged at the center of the shapeable part 21, 31, for accommodating the user's teeth. Considering the difference in size of different teeth, the distance between the front wall 2111 and the back 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 and lower dental arches. Therefore, the size of the first groove 211, 311 is set to adapt to the shape of different teeth: the width of the middle (central incisor position) is smaller than that of the two sides (molar position), and the height of the middle (central incisor position) is greater than that of the two 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 height of the shapeable parts 21, 31 varies at different positions, which takes into account the curved characteristics of the oral structure, so there is a difference in height in its shape. At the same time, the overall shape of the tray assembly 2, 3 also takes into account the curved characteristics of the oral structure, also with a difference in height. As part of the tray assembly 2, 3, the overall shape of the shapeable parts 21, 31 is adapted accordingly to the difference in height of the tray assembly 2, 3, to ensure that the oral appliance 1 fits better with the user's teeth and oral structure, providing better comfort and use experience. When the user bites, the shapeable parts 21, 31 can form a closer contact with the teeth and oral structure, effectively improving the fit of the oral appliance 1. At the same time, this design makes it easier for the user to bite. This design not only improves the adaptability and fit of the oral appliance 1, but also improves the comfort of the user when wearing the oral appliance 1, thereby improving the treatment effect and user experience.

[0107] 5) The shapeable parts 21, 31 are made of flexible material, which is easier to adapt to the oral cavity compared to the brackets 22, 32, reducing irritation and scratches to the oral soft tissue. Therefore, the horizontal projection area of the shapeable parts 21, 31 is set to be larger than that of the brackets 22, 32, which can reduce the contact pressure of the oral appliance 1 on the oral soft tissue, further reducing the risk of scratches. In addition, considering the difference in distance from the inside of the lips to the back of the molars of different users, the oral appliance 1 of the present application is designed to allow the user to adjust the length by trimming to adapt to this distance. The soft shapeable parts 21, 31 allow the user to easily trim and adjust the device length according to individual needs, thereby improving the comfort and personalized adaptability of use. It is worth noting that since the horizontal projection area of the shapeable parts 21, 31 is larger than that of the brackets 22, 32, the structure and function of the brackets 22, 32 will not be affected during trimming, thereby ensuring the stability of the oral appliance 1.

[0108] Any combination of the technical features in the above-described embodiments can be made, and for the sake of brevity, not all possible combinations are described, however, as long as the combination of the technical features does not exist in contradiction, it shall be considered within the scope of the present disclosure.

[0109] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it shall not be understood as a limitation on the patent scope of the present application. It shall be pointed out that, for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these shall be within the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A shapeable oral appliance, comprising: an upper tray assembly configured to be positioned on a user's upper dentition; a lower tray assembly configured to be positioned on a user's lower dentition; said upper tray assembly comprising an upper shapeable component and an upper support; said lower tray assembly comprising a lower shapeable component and a lower support; wherein said upper shapeable component and said lower shapeable component are made of a material that is shapeable and can be deformed upon heating, and said upper support and said lower support do not deform upon heating to a temperature required for said upper shapeable component and said lower shapeable component to deform; said upper shapeable component and said lower shapeable component each having at least one recess; said recess comprising a first recess having a front wall and a back wall, a distance between said front wall and said back wall being at least partially variable.

2. The oral appliance of claim 1, wherein, The material of said upper shapeable component and lower shapeable component is a medical grade shapeable material.

3. The oral appliance of claim 1, wherein, Said upper shapeable component and lower shapeable component do not damage their material or properties during deformation.

4. The oral appliance of claim 1, wherein, Said upper shapeable component and lower shapeable component allow for minor deformation while retaining their deformed shape.

5. The oral appliance of claim 1, wherein, The width of said first recess in the middle is less than the width of said first recess on both sides.

6. The oral appliance of claim 1, wherein, The height of said first recess in the middle is greater than the height of said first recess on both sides.

7. A shapeable oral appliance, comprising: an upper tray assembly configured to be positioned on a user's upper dentition; a lower tray assembly configured to be positioned on a user's lower dentition; said upper tray assembly comprising an upper shapeable component and an upper support; said lower tray assembly comprising a lower shapeable component and a lower support; wherein said upper shapeable component and said lower shapeable component are made of a material that is shapeable and can be deformed upon heating, and said upper support and said lower support do not deform upon heating to a temperature required for said upper shapeable component and said lower shapeable component to deform; said upper shapeable component and said lower shapeable component each having a first recess; said upper shapeable component and said lower shapeable component each having at least partially a second recess in any cross section perpendicular to a horizontal plane, said second recess configured to prevent said upper shapeable component and said lower shapeable component from overflowing a defined range during heating and shaping.

8. The oral appliance of claim 7, wherein, Said upper shapeable component and lower shapeable component are at least partially made of a flexible thermoplastic material.

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

10. The oral appliance of claim 7, wherein, Said first recess is configured to accommodate a user's teeth.

11. The oral appliance of claim 7, wherein, Said upper shapeable component and lower shapeable component do not produce harmful substances or odors during heating and shaping.

12. A shapeable oral appliance, comprising: an upper tray assembly configured to be positioned on a user's upper dentition; a lower tray assembly configured to be positioned on a user's lower dentition; said upper tray assembly comprising an upper shapeable component and an upper support; said lower tray assembly comprising a lower shapeable component and a lower support; The upper and lower shapeable components are made of a material that is shapeable and can be deformed when heated, and the upper and lower supports do not deform when heated to a temperature required for the upper and lower shapeable components to deform; The upper and lower shapeable components each have at least one groove; The upper shapeable component has a projected area on a horizontal plane that is larger than a projected area of the upper support on the horizontal plane; The lower shapeable component has a projected area on a horizontal plane that is larger than a projected area of the lower support on the horizontal plane.

13. The oral appliance of claim 12, wherein, The upper and lower shapeable components each have a height of at least a portion of 0.5-30mm.

14. The oral appliance of claim 12, wherein, The upper and lower shapeable components each have a height of at least a portion of 0.5-30mm.

15. The oral appliance of claim 14, wherein, The upper and lower shapeable components each have a height of at least a portion of 0.5-30mm.

16. The oral appliance of claim 14, wherein, The upper and lower shapeable components each have a height of at least a portion of 0.5-30mm.

17. A shapeable oral appliance, comprising: an upper tray assembly configured to be positioned on a user's upper dentition; a lower tray assembly configured to be positioned on a user's lower dentition; the upper tray assembly comprising an upper shapeable component and an upper support; the lower tray assembly comprising a lower shapeable component and a lower support; The upper and lower shapeable components are made of a material that is shapeable and can be deformed when heated, and the upper and lower supports do not deform when heated to a temperature required for the upper and lower shapeable components to deform; The upper and lower shapeable components each have a first groove; The upper and lower shapeable components each have a second groove; The upper and lower shapeable components have one or more of the following properties: The first groove has a bottom wall, and the vertical distance between the bottom wall and the upper support and / or the lower support is in a range of 1-15mm; The second groove has a bottom wall, and the vertical distance between the bottom wall and the upper support and / or the lower support is in a range of 0.5-15mm; The first groove has a projected area on a horizontal plane that occupies a proportion of 10-90% of a projected area of the upper shapeable component and / or the lower shapeable component on the horizontal plane.

18. The oral appliance of claim 17, wherein, The second groove has a front wall and a back wall, and the distance between the front wall and the back wall is in a range of 0.1-10mm.

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

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

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

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