Oral appliance

Abstract

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

Description

TECHNICAL FIELD

[0001] The 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] Obstructive sleep apnea is a sleep-related breathing disorder in which muscles relax during sleep causing narrowing and closure of the upper airway resulting in repetitive episodes of complete or partial obstruction. This results in severe disruptions of normal breathing, typically causing the user to stop breathing for 10 seconds or more, 5 to 30 times or more per hour. The condition leads to excessive daytime sleepiness, morning headaches, and cardiovascular and brain damage complications.

[0003] There are many methods to prevent snoring and / or obstructive sleep apnea, one of which is to increase the airflow of the throat passage by pushing the position of the lower jaw relative to the upper jaw. It has been proven since the 19th century that pushing the lower jaw can increase the airflow of the throat passage, thereby reducing or eliminating the occurrence of snoring and / or obstructive sleep apnea.

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

[0005] Although the oral appliance helps to reduce or eliminate snoring and / or obstructive sleep apnea, the customization of such a device by a dental care professional requires additional work and the user needs to frequently visit the dental clinic for customization or adjustment, thereby increasing the user's time and monetary costs. In addition, if the shaping of the mandibular advancement device is done by the user, especially by the individual himself, it often leads to problems such as poor comfort. SUMMARY

[0006] The present invention is based on the above-mentioned deficiencies, and provides an oral appliance that is convenient for the user to use, reduces the user's use cost, and is comfortable to wear.

[0007] An oral appliance, comprising:

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

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

[0010] The upper tray assembly comprises an upper moldable component and an upper support;

[0011] The lower tray assembly comprises a lower moldable component and a lower support;

[0012] 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;

[0013] The upper moldable component is configured to be detachably connected with the upper support;

[0014] The lower moldable component is configured to be detachably connected with the lower support;

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

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

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

[0018] 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.

[0019] 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.

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

[0021] In one embodiment, the upper support and the lower support are at least partially made of a material with higher rigidity than the upper moldable component and the lower moldable component.

[0022] The present application also discloses an oral appliance comprising:

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

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

[0025] The upper tray assembly comprises an upper moldable component and an upper support;

[0026] The lower tray assembly comprises a lower moldable component and a lower support;

[0027] The upper and lower plastic components are made of a material with plasticity and can be deformed when heated. The upper and lower supports do not deform when heated to a temperature required for the upper and lower plastic components to deform.

[0028] The upper plastic component is configured to be detachably connected with the upper support.

[0029] The lower plastic component is configured to be detachably connected with the lower support.

[0030] The upper plastic component has a projection area on a horizontal plane that is greater than a projection area of the upper support on the horizontal plane.

[0031] The lower plastic component has a projection area on a horizontal plane that is greater than a projection area of the lower support on the horizontal plane.

[0032] In one embodiment, the upper and lower plastic components are made of a material with plasticity, and the temperature required for the upper and lower plastic components to deform when heated is less than 100 degrees Celsius.

[0033] In one embodiment, the upper and lower supports are made of a material with high temperature stability, and the temperature required for the upper and lower supports to deform when heated is greater than 100 degrees Celsius.

[0034] In one embodiment, the ratio of the sum of the projection areas of the upper and lower plastic components on a horizontal plane to the sum of the projection areas of the upper and lower supports on the horizontal plane is greater than 1.

[0035] In one embodiment, the lengths of the outwardly extending end portions of the upper and lower plastic components are greater than the lengths of the outwardly extending end portions of the upper and lower supports.

[0036] The present application also discloses an oral appliance comprising:

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

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

[0039] The upper tray assembly comprises an upper plastic component and an upper support.

[0040] The lower tray assembly comprises a lower plastic component and a lower support.

[0041] The upper tray assembly and / or the lower tray assembly have a connecting portion configured to connect the upper plastic component and the upper support and to connect the lower plastic component and the lower support, respectively.

[0042] wherein 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 at which the upper and lower shapeable components deform;

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

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

[0045] In one embodiment, the upper and lower supports are detachably connected to the upper and lower shapeable components, respectively, by additional components.

[0046] In one embodiment, the connecting portion includes a protrusion, a slot, and / or additional components such as a latch, a screw, a pin, and a magnet.

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

[0048] In one embodiment, the protrusion is located on the upper and lower shapeable components and matches a slot on the upper and lower supports, respectively.

[0049] In one embodiment, the slot is located on the upper and lower shapeable components and matches a protrusion on the upper and lower supports, respectively.

[0050] The present application also discloses an oral appliance, comprising:

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

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

[0053] the upper tray assembly includes an upper shapeable component and an upper support;

[0054] the lower tray assembly includes a lower shapeable component and a lower support;

[0055] wherein 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 at which the upper and lower shapeable components deform;

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

[0057] The lower moldable component is configured to be detachably connected with the lower holder;

[0058] The upper holder and / or the lower holder has at least one slot.

[0059] In one embodiment, the slots of the upper holder and the lower holder are configured to accommodate the material overflowed from the upper moldable component and the lower moldable component during the hot melting process.

[0060] In one embodiment, the shape of the upper moldable component and the lower moldable component adopts at least one of an oval arch, a tapered arch, and a square arch to conform to the curve of the user's dentition.

[0061] In one embodiment, the upper holder and the lower holder each has an inner wall and an outer wall, and the distance between the inner wall and the outer wall is at least a portion of 0.3-8mm.

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

[0063] 1) Since the moldable component and the holder are designed to be detachably connected, and the process of detaching and installing them is simple and easy, the user can quickly and conveniently replace the moldable component without replacing the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only part of the assembly needs to be replaced instead of the entire device, this design significantly reduces the waste of materials, helps to reduce resource consumption, and thus embodies significant environmental friendliness and climate friendliness. By reducing waste and reusing resources, the present application helps to reduce carbon emissions and environmental load.

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

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

[0066] 4) The bracket has a groove that not only can fix the protrusion of the shapeable component therein, but also can accommodate the material overflowed from the shapeable component during the hot melting process. The overflowed material fills the groove after cooling, thereby further enhancing the fixing effect between the bracket and the shapeable component. The present invention achieves double fixation of the shapeable component by designing a groove structure on the bracket, which not only improves the stability of the connection, but also simplifies the installation process, ensuring the reliability of the device during use. In addition, the structure of the connection part between the bracket and the shapeable component is relatively simple, so that the shapeable component can be easily removed from the bracket, thereby realizing the detachable function of the device, facilitating maintenance and replacement.

[0067] 5) Compared with the bracket, the shapeable component is made of flexible material, which can better adapt to the oral cavity and reduce the irritation and scratches to the oral soft tissue. At the same time, the horizontal projection area of the shapeable component is larger than that of the bracket, which helps to reduce the contact pressure on the oral soft tissue and further reduce the risk of scratches. Considering that the distance from the inner side of the lip to the posterior region of the molar varies among different users, the oral appliance designed by the present invention allows the user to adjust the length by trimming to adapt to the distance from the inner side of the lip to the posterior region of the molar. The soft shapeable component allows the user to easily trim and adjust the length of the device 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 component is larger than that of the bracket, the structure and function of the bracket will not be affected during trimming, thereby ensuring the stability and effectiveness of the oral appliance. BRIEF DESCRIPTION OF DRAWINGS

[0068] Figure 1 is a schematic view of the overall oral appliance in an embodiment of the present invention;

[0069] Figure 2 is a schematic view of the structure of the oral appliance in multiple embodiments of the present invention;

[0070] Figure 3 is a top view of the shapeable component and the dentition shape in multiple embodiments of the present invention;

[0071] Figure 4 This is a schematic diagram of the horizontal plane, sagittal plane, and coronal plane in several embodiments of the present invention;

[0072] Figure 5 This is a top view of the upper tray assembly in several embodiments of the present invention;

[0073] Figure 6 This is a cross-sectional schematic diagram of the connecting portion in one embodiment of the present invention;

[0074] Figure 7 This is a schematic diagram of the lower tray assembly in one embodiment of the present invention;

[0075] Figure 8 This is an exploded view of the upper malleable component and the upper support structure in Embodiment 1 of the present invention;

[0076] Figure 9 This is a cross-sectional schematic diagram of the upper malleable component and the upper support in Embodiment 1 of the present invention;

[0077] Figure 10 This is an exploded view of the upper malleable component and the upper support structure in Embodiment 2 of the present invention;

[0078] Figure 11 This is an exploded view of the upper malleable component and the upper support structure in Embodiment 2 of the present invention;

[0079] Figure 12 This is a cross-sectional schematic diagram of the upper malleable component and the end of the upper support in Embodiment 2 of the present invention;

[0080] Figure 13 This is a partial comparison diagram of the connection between the upper malleable component and the upper support before and after boiling in Embodiment 3 of the present invention. Detailed Implementation

[0081] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0082] The present invention relates to an oral appliance 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 sport guard for the upper dentition, lower dentition or both dentitions. In some embodiments, the appliance can also function as a mouth guard for the upper dentition, lower dentition or both dentitions.

[0083] The present invention provides an oral appliance 1 that is convenient for a user to use, reduces the cost of use for the user and is comfortable to wear.

[0084] In particular, referring to Figures 1 to 3 The oral appliance 1 of the present invention comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be positioned adjacent to the upper dentition of the user when positioned in the oral cavity of the user. The lower tray assembly 3 is configured to be positioned adjacent to the lower dentition of the user when positioned in the oral cavity of the user. Further, the upper tray assembly 2 is positioned below the upper dentition of the user when positioned in the oral cavity of the user. The lower tray assembly 3 is positioned above the lower dentition of the user when positioned in the oral cavity of the user. The dentition typically exhibits an arcuate structure that conforms to the natural arrangement of the teeth of the user, and in particular, the upper dentition and the lower dentition each form a generally symmetrical and approximately arcuate curve. The upper tray assembly 2 and the lower tray assembly 3 are therefore configured to conform to the arcuate structure of the curve of the dentition of the user so as to better fit the upper and lower teeth of the user, thereby providing sufficient support and stability to the oral appliance 1.

[0085] The upper tray assembly 2 comprises an upper moldable part 21 and an upper support 22, and the lower tray assembly 3 comprises a lower moldable part 31 and a lower support 32. In the present application, the supports 22, 32 comprise the upper support 22 and the lower support 32, and the moldable parts 21, 31 comprise the upper moldable part 21 and the lower moldable part 31. The materials of the upper tray assembly 2 and the lower tray assembly 3 can be selected from a wide range of materials, and plastic 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), polyphenyl sulfone (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, which are beneficial to 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 supports 22, 32, can be made of a single material or a combination of multiple materials. This multi-material combination design 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 material 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 polymer material types include thermoplastic, thermoset polymer, elastomer and thermoplastic elastomer. These materials can be copolymers, terpolymers, or mixtures of different types of polymers, such as mixtures of thermoplastics with different molecular weights. These materials have good processing properties and mechanical properties, which are beneficial to the manufacture of the oral appliance 1.

[0086] The upper tray assembly 2 and / or the lower tray assembly 3 further comprises a fixing part 4 configured to connect and / or fix the upper tray assembly 2 and the lower tray assembly 3. When the user uses the oral appliance, the fixing part 4 fixes the user's lower jaw in a forward position relative to the user's upper jaw to achieve the function of forward displacement of the lower jaw.

[0087] The material selection of the fixed portion 4 should take into account that it needs to tightly connect the tray assemblies 2, 3 to ensure the stability and reliability of the mouth appliance 1. The material of the fixed portion 4 can be a moldable material or a polymer material consistent with the upper tray assembly 2 and the lower tray assembly 3, or other materials suitable for oral medical devices and appliances such as metal, etc. The fixed portion 4 can be made of a single material or a combination of multiple materials.

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

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

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

[0091] The shapeable component 21, 31 is configured to be detachably connected with the bracket 22, 32. As Figure 6 shown, the upper tray assembly 2 and / or the lower tray assembly 3 has a connecting portion 5 configured to connect the shapeable component 21, 31 and the bracket 22, 32. Among them, the connecting portion 5 includes protrusions 54, 55, grooves 52, 53 Figure 6 part A) and / or additional components 56 such as pins, screws, nails, magnets Figure 6i.e. the brace 22, 32 can be detachably connected with the shapeable component 21, 31 in the form of a snap and / or additional external components. In the present application, the design of the shapeable component 21, 31 and the brace 22, 32 as detachable connection is based on multiple considerations. First, since the shapeable component 21, 31 is detachably connected with the brace 22, 32, and the process of its disassembly and installation is simple and easy to operate, the user can quickly and conveniently replace the shapeable component 21, 31 without the need to replace the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only part of the assembly needs to be replaced instead of the entire device, this design significantly reduces the waste of materials, helps to reduce resource consumption, and thus embodies significant environmental friendliness and climate friendliness. By reducing the generation of waste and the reuse of resources, the present application helps to reduce carbon emissions and environmental load.

[0092] Secondly, the shapeable component 21, 31 is made of a plastic material that can be deformed when heated, so that the user can complete the adaptive adjustment by heating and shaping by himself. The user only needs to heat the upper tray assembly 2 and the lower tray assembly 3 in hot water, and then lightly bite the upper tray assembly 2 and the lower tray assembly 3 with the mouth, so that the upper tray assembly 2 and the lower tray assembly 3 form a good fit with the teeth, thereby shaping the heated shapeable component 21, 31 by biting to achieve the fit with the dentition. If there are problems such as operation errors or improper biting during the biting process, since the shapeable component 21, 31 and the brace 22, 32 are designed to be detachably connected, the user can replace the shapeable component 21, 31 and re-bite without the need to replace the entire device. This design not only significantly reduces the waste of resources and money, but also improves the adjustability of the device and the user experience.

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

[0094] As Figure 7As shown, the projection area of the shapeable components 21, 31 on the horizontal plane is greater than the projection area of the brackets 22, 32 on the horizontal plane, that is, the ratio of the sum of the projection areas of the upper and lower shapeable components 21, 31 on the horizontal plane to the sum of the projection areas of the upper and lower brackets 22, 32 on the horizontal plane is greater than 1, to provide greater comfort and stability. Among them, the projection area of the bracket 22, 32 on the horizontal plane is not greater than 60 square centimeters, and the length of the outwardly extending end of the shapeable component 21, 31 is greater than the length of the outwardly extending end of the bracket 22, 32. The horizontal projection area of the shapeable component 21, 31 is designed to be larger than the bracket 22, 32, mainly for the following considerations: first, the shapeable component 21, 31 is made of flexible material, which is more adaptable to the oral cavity and reduces the irritation and scratching of the oral soft tissue. Secondly, due to the larger projection area of the shapeable component 21, 31, 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 side of the lip to the posterior region of the molar of different users, an excessively long device can cause scratching of the posterior oral tissue of the molar, especially in the area located at the joint, and an ill-fitting device can affect the occlusal function. The oral appliance 1 design in this embodiment allows the user to adjust the length by trimming to adapt to the distance from the inner side of the lip to the posterior region of the molar, and the soft shapeable component 21, 31 allows 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 component 21, 31 has a larger horizontal projection area than the bracket 22, 32, so that the bracket 22, 32 will not be 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.

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

[0096] Example 1

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

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

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

[0100] The protrusions 54, 55 are located on the shapeable component 21, 31 and match the grooves 52, 53 on the bracket 22, 32. The protrusions 54, 55 are integrally formed with the shapeable component 21, 31 and are configured in a shape that is easy to produce, install and detach, i.e., the shape of the protrusions 54, 55 adopts at least one of a cylindrical shape, a square shape, a spherical shape, a T shape, an L shape or other shapes. The bracket 22, 32 includes an inner wall 221 and an outer wall 222, and the inner wall 221 of the bracket forms a cavity for accommodating the shapeable component 21, 31. During installation, the shapeable component 21, 31 is placed on the bracket 22, 32 so that the outer wall 211 of the shapeable component 21, 31 at least partially contacts the inner wall 221 of the bracket 22, 32, and then the protrusions 54, 55 on the shapeable component 21, 31 are inserted into the grooves 52, 53 at the corresponding positions of the bracket 22, 32. The grooves 52, 53 on the bracket 22, 32 have a sufficient depth, which is in the range of 0.2-20 mm, to form a stable connection with the protrusions 54, 55 on the shapeable component 21, 31.

[0101] Example 2

[0102] The oral appliance 1 of the present embodiment comprises: an upper tray assembly 2 configured to be positioned adjacent to the upper dentition of a user when positioned in the oral cavity of the user; and a lower tray assembly 3 configured to be positioned adjacent to the lower dentition of a user when positioned in the oral cavity of the user. The upper tray assembly 2 comprises an upper moldable component 21 and an upper support 22. The lower tray assembly 3 comprises a lower moldable component 31 and a lower support 32. In the present embodiment, the supports 22, 32 comprise the upper support 22 and the lower support 32, and the moldable components 21, 31 comprise the upper moldable component 21 and the lower moldable component 31.

[0103] The moldable components 21, 31 are made of a material that is moldable and can be deformed when heated, and the supports 22, 32 do not deform when heated to a temperature at which the moldable components 21, 31 deform. The moldable components 21, 31 are configured to be detachably connected to the supports 22, 32. The upper tray assembly 2 and / or the lower tray assembly 3 has a connecting portion 5 configured to connect the moldable components 21, 31 and the supports 22, 32. The connecting portion 5 comprises protrusions 54, 55 and grooves 52, 53.

[0104] The present embodiment differs from embodiment 1 in that the protrusions and grooves of the moldable components 21, 31 and the supports 22, 32 are arranged in reverse, but function in the same way. The grooves 52, 53 are located on the moldable components 21, 31 and match the protrusions 54, 55 on the supports 22, 32. The supports 22, 32 comprise inner walls 221 and outer walls 222, and the inner walls 221 of the supports form a cavity for accommodating the moldable components 21, 31. The grooves 52, 53 are located on the moldable components 21, 31 and have shapes that correspond to the protrusions 54, 55. For better fixing effect, it is preferred that the supports 22, 23 and the moldable components 21, 31 each have four protrusions 54, 55 and grooves 52, 53, i.e. two on each side adjacent to the middle part (i.e. the position of the oral appliance close to the user's incisors) and two at the ends (i.e. the end of the oral appliance close to the user's temporomandibular joint). Taking the upper tray assembly 2 as an example, as shown in FIG. 2, four grooves 52, 53 are provided on the upper moldable component 21, two of which are located on each side adjacent to the middle part of the upper moldable component 21, and the other two are located at the ends of the upper moldable component 21. Figure 10

[0105] In other embodiments, the grooves 53 at the ends of the moldable components 21, 31 are in the form of covering the ends of the supports 22, 32, as shown in FIG. 3. Figure 11 Figure 12 ​​As shown, the shapeable components 21, 31 extend from both ends of the supports 22, 32 by a certain length, and then extend in the opposite direction to form hollow grooves 53 covering the protrusions 55 of the supports 22, 32. This structure makes the two ends of the shapeable components 21, 31 longer than the two ends of the supports 22, 32, avoiding the relatively rigid supports 22, 32 from touching the user's molar posterior region, and replacing the relatively soft shapeable components 21, 31 to better adapt to the oral cavity, reducing the irritation and scratches to the user's molar posterior region.

[0106] Embodiment 3

[0107] The oral appliance 1 of the present embodiment comprises: an upper tray assembly 2 configured to be positioned adjacent to the user's upper dentition when positioned in the user's oral cavity; and a lower tray assembly 3 configured to be positioned adjacent to the user's lower dentition when positioned in the user's oral cavity. The upper tray assembly 2 comprises an upper shapeable component 21 and an upper support 22; and the lower tray assembly 3 comprises a lower shapeable component 31 and a lower support 32. In the present embodiment, the supports 22, 32 comprise the upper support 22 and the lower support 32, and the shapeable components 21, 31 comprise the upper shapeable component 21 and the lower shapeable component 31.

[0108] The shapeable components 21, 31 are made of a material with plasticity, which can be deformed when heated, and the supports 22, 32 do not deform when heated to a temperature required for the shapeable components 21, 31 to deform. The shapeable components 21, 31 are configured to be detachably connected with the supports 22, 32. The upper tray assembly 2 and / or the lower tray assembly 3 have a connecting portion 5 configured to connect the shapeable components 21, 31 and the supports 22, 32. The connecting portion 5 comprises protrusions 54, 55, grooves 51, 52, 53.

[0109] In the present embodiment, the shapeable components 21, 31 have at least the protrusions 54, 55, and the supports 22, 32 have the grooves 51, 52, 53. The protrusions 54, 55 of the shapeable components 21, 31 correspond to the grooves 52, 53 of the supports 22, 32. In addition, the supports 22, 32 comprise an inner wall 221, an outer wall 222, and a groove 51, and the distance between the inner wall 221 and the outer wall 222 is at least a portion of 0.3-8 mm. When the user heats the oral appliance 1 in hot water and bites the oral appliance 1 with the mouth, the shapeable components 21, 31 will deform due to the occlusion, and the excess part will overflow from all around, which not only causes discomfort due to the protrusions on the surface of the oral appliance 1, but also affects the appearance. Therefore, the present embodiment provides the groove 51 on the support 22, 32, which is configured to accommodate the material overflowed from the shapeable components 21, 31 during the hot melting process. As shown, the groove 51 penetrates the inner wall 221 and the outer wall 222 of the support 22, 32 (as shown in FIG. 2B). Figure 13 As shown, the groove 51 penetrates the inner wall 221 and the outer wall 222 of the support 22, 32 (as Figure 13A portion of the disclosure of this patent document contains material which is subject to copyright protection. This copyright protection has been applied for by the assignee hereof. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. When the moldable component 21, 31 is hot-melted, the overflow from the groove 51 forms protrusions (as shown in FIG. 2B) due to the different structures and material properties of the moldable component 21, 31. Therefore, the groove 51 needs to have a sufficient capacity to accommodate the overflow, and the horizontal area of the groove 51 is at least 3 mm2. When the moldable component 21, 31 cools down, the overflow from the groove 51 cools down and forms protrusions (as shown in FIG. 2B) due to the different structures and material properties of the moldable component 21, 31. Therefore, the groove 51 needs to have a sufficient capacity to accommodate the overflow, and the horizontal area of the groove 51 is at least 3 mm2. Figure 13 The protrusions further enhance the fixation between the bracket 22, 32 and the moldable component 21, 31.

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

[0111] The oral appliance 1 with a foam pad according to the present application has at least the following advantages:

[0112] 1) Since the moldable component 21, 31 and the bracket 22, 32 are designed to be detachably connected, and the detachment and installation process is simple and easy, the user can quickly and conveniently replace the moldable component 21, 31 without replacing the entire device, thereby improving the flexibility and maintainability of the device. In addition, since only part of the assembly needs to be replaced instead of the entire device, this design significantly reduces material waste, helps to reduce resource consumption, and thus embodies significant environmental friendliness and climate friendliness. By reducing waste and reusing resources, the present application helps to reduce carbon emissions and environmental load.

[0113] 2) The moldable component 21, 31 is made of a plastic material that can be deformed when heated. The user can place the heated moldable component 21, 31 in the oral cavity and shape it by biting to fit the dentition. If there are problems such as operation errors or improper biting during the biting process, since the moldable component 21, 31 and the bracket 22, 32 are designed to be detachably connected, the user can replace the moldable component 21, 31 and re-bite without replacing the entire device. This design not only significantly reduces resource and money waste, but also improves the adjustability of the device and user experience.

[0114] 3) The shapeable component 21, 31 is made of flexible thermoplastic material and is used to bear the biting force of the user, so its service life is generally shorter than that of the bracket 22, 32. When the shapeable component 21, 31 is damaged or needs to be replaced, since it is designed to be detachably connected with the bracket 22, 32, only the shapeable component 21, 31 needs to be replaced, without the need to replace the entire device. In addition, if the bracket 22, 32 needs to be replaced, while the shapeable component 21, 31 can still be used, the shaped shapeable component 21, 31 can be installed on the new bracket 22, 32 without the need to reshape. This design not only saves time, but also effectively reduces the waste of resources and money, significantly improving the economy and use efficiency of the device. By reducing material consumption and prolonging the service life of each component, it helps to reduce carbon emissions and environmental load.

[0115] 4) The bracket 22, 32 has a groove 51, 52, 53, which not only can fix the protrusion 54, 55 of the shapeable component 21, 31 therein, but also can accommodate the material overflowed by the shapeable component 21, 31 during the hot melting process. The overflowed material fills the groove 51 after cooling, thereby further enhancing the fixing effect between the bracket 22, 32 and the shapeable component 21, 31. By designing the groove structure on the bracket 22, 32, the present application achieves double fixation of the shapeable component 21, 31, which not only improves the stability of the connection, but also simplifies the installation process, ensuring the reliability of the device during use. In addition, the structure of the bracket 22, 32 and the shapeable component connection part 5 is relatively simple, so that the shapeable component 21, 31 can be easily removed from the bracket 22, 32, thereby realizing the detachable function of the device, facilitating maintenance and replacement.

[0116] 5) Compared with the bracket 22, 32, the shapeable component 21, 31 uses flexible material, which can better adapt to the oral cavity and reduce irritation and scratches to the oral soft tissue. At the same time, the horizontal projection area of the shapeable component 21, 31 is larger than that of the bracket 22, 32, which helps to reduce the contact pressure on the oral soft tissue and further reduce the risk of scratches. Considering that the distance from the inner side of the lip to the posterior region of the molar varies among different users, the oral appliance 1 design of the present application allows the user to adjust the length by trimming to adapt to the distance from the inner side of the lip to the posterior region of the molar. The soft shapeable component 21, 31 allows the user to easily trim and adjust the length of the device 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 component 21, 31 is larger than that of the bracket 22, 32, the structure and function of the bracket 22, 32 will not be affected during trimming, thereby ensuring the stability and effectiveness of the oral appliance 1.

[0117] 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.

[0118] 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 present application patent shall be subject to the appended claims.

Claims

1. An oral appliance comprising: an upper tray assembly configured to be positioned adjacent to a user's upper dentition when positioned in the user's oral cavity; a lower tray assembly configured to be positioned adjacent to a user's lower dentition when positioned in the user's oral cavity; the upper tray assembly comprising an upper moldable component and an upper support; the lower tray assembly comprising a lower moldable component and a lower support; wherein the upper and lower moldable components are made of a material that is moldable and can be deformed when heated, and the upper and lower supports do not deform when heated to a temperature required to deform the upper and lower moldable components; the upper moldable component is configured to be detachably connected to the upper support; the lower moldable component is configured to be detachably connected to the lower support; the upper and lower moldable components have outer walls; the upper and lower supports have inner walls; the outer walls of the upper and lower moldable components are at least partially in contact with the inner walls of the upper and lower supports, respectively.

2. The oral appliance of claim 1, wherein, the upper tray assembly is configured to have an arched shape that conforms to a curvature of the user's upper dentition.

3. The oral appliance of claim 1, wherein, the lower tray assembly is configured to have an arched shape that conforms to a curvature of the user's lower dentition.

4. The oral appliance of claim 1, wherein, the upper and lower moldable components are at least partially made of a flexible thermoplastic material.

5. The oral appliance of claim 1, wherein, the upper and lower supports are at least partially made of a material that has a higher rigidity than the upper and lower moldable components.

6. An oral appliance comprising: an upper tray assembly configured to be positioned adjacent to a user's upper dentition when positioned in the user's oral cavity; a lower tray assembly configured to be positioned adjacent to a user's lower dentition when positioned in the user's oral cavity; the upper tray assembly comprising an upper moldable component and an upper support; the lower tray assembly comprising a lower moldable component and a lower support; wherein the upper and lower moldable components are made of a material that is moldable and can be deformed when heated, and the upper and lower supports do not deform when heated to a temperature required to deform the upper and lower moldable components; the upper moldable component is configured to be detachably connected to the upper support; the lower moldable component is configured to be detachably connected to the lower support; the upper moldable component has a larger projected area on a horizontal plane than the upper support; the lower moldable component has a larger projected area on a horizontal plane than the lower support.

7. The oral appliance of claim 6, wherein, the upper and lower moldable components are made of a material that is moldable and can be deformed when heated to a temperature that is less than 100 degrees Celsius.

8. The oral appliance of claim 6, wherein, the upper and lower supports are made of a material that has a high temperature stability and can be deformed when heated to a temperature that is greater than 100 degrees Celsius.

9. The oral appliance of claim 6, wherein, a ratio of a sum of projected areas on a horizontal plane of the upper and lower moldable components to a sum of projected areas on a horizontal plane of the upper and lower supports is greater than 1.

10. The oral appliance of claim 6, wherein, lengths of outwardly extending end portions of the upper and lower moldable components are greater than lengths of outwardly extending end portions of the upper and lower supports.

11. An oral appliance comprising: an upper tray assembly configured to be positioned adjacent to the upper dentition of the user when positioned in the oral cavity of the user; a lower tray assembly configured to be positioned adjacent to the lower dentition of the user when positioned in the oral cavity of the user; the upper tray assembly comprises an upper moldable component and an upper support; the lower tray assembly comprises a lower moldable component and a lower support; the upper tray assembly and / or the lower tray assembly has a connecting portion configured to connect the upper moldable component and the upper support and the lower moldable component and the lower support, respectively; wherein the upper and lower moldable components are made of a material that is moldable 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 moldable components to deform; the upper moldable component is configured to be detachably connected to the upper support; the lower moldable component is configured to be detachably connected to the lower support.

12. The oral appliance of claim 11, wherein, the upper and lower supports are detachably connected to the upper and lower moldable components, respectively, by additional components.

13. The oral appliance of claim 11, wherein, the connecting portion comprises a protrusion, a slot, and / or additional components such as a latch, a screw, a pin, a magnet.

14. The oral appliance of claim 13, wherein, the protrusion has at least one of a cylindrical shape, a square shape, a spherical shape, a T-shape, and an L-shape.

15. The oral appliance of claim 13, wherein, the protrusion is located on the upper and lower moldable components and matches a slot on the upper and lower supports, respectively.

16. The oral appliance of claim 13, wherein, the slot is located on the upper and lower moldable components and matches a protrusion on the upper and lower supports, respectively.

17. An oral appliance comprising: an upper tray assembly configured to be positioned adjacent to the upper dentition of the user when positioned in the oral cavity of the user; a lower tray assembly configured to be positioned adjacent to the lower dentition of the user when positioned in the oral cavity of the user; the upper tray assembly comprises an upper moldable component and an upper support; the lower tray assembly comprises a lower moldable component and a lower support; wherein the upper and lower moldable components are made of a material that is moldable 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 moldable components to deform; the upper moldable component is configured to be detachably connected to the upper support; the lower moldable component is configured to be detachably connected to the lower support. the upper and / or lower support has at least one slot.

18. The oral appliance of claim 17, wherein, the slot of the upper and lower supports is configured to hold the material overflowed from the upper and lower moldable components during the heat-melting process.

19. The oral appliance of claim 17, wherein, the upper and lower moldable components have at least one of an oval arch shape, a tapered arch shape, and a square arch shape to conform to the curve of the dentition of the user.

20. The oral appliance of claim 17, wherein, the upper and lower supports each have an inner wall and an outer wall, and the distance between the inner wall and the outer wall is at least partially between 0.3 mm and 8 mm.

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