Lower jaw advancing device with supporting baffle

Abstract

The utility model relates to a mandibular advancement device, in particular to a mandibular advancement device with a supporting baffle, which has the advantages that the service life is prolonged, the treatment effectiveness and the use comfort of a patient are improved, and the mandibular advancement device consists of an upper tray component and a lower tray component. Wherein the upper tray assembly further comprises an upper moldable part and an upper support, and the lower tray assembly further comprises a lower moldable part and a lower support. The mandibular advancement device is characterized in that the lower support is provided with a supporting baffle, and the supporting baffle is constructed to be located at the position, close to the tongue side, of the lower support in the using process. And various parameters of the supporting baffle are limited, so that the mandibular advancement device which is more suitable for the patient to use compared with the existing device on the market is obtained.

Description

Technical Field

[0001] The utility model relates to a mandibular advancement device with a support baffle, in particular to a device for preventing, reducing or eliminating snoring and obstructive sleep apnea. Background Art

[0002] Sleep Apnea Syndrome (SAS) is one of the most common sleep and breathing disorders, and obstructive sleep apnea / hypopnea syndrome is the most common type of sleep apnea syndrome. Obstructive apnea is caused by the complete or partial obstruction of the airway by relaxed muscles and other tissues during sleep, which may be caused by a variety of factors, including but not limited to soft tissue relaxation, pharyngeal muscle relaxation, uvula and tongue side abnormalities, etc. At present, patients generally prefer non-surgical treatment, and using a mandibular advancement device for treatment is one of the means of non-surgical treatment.

[0003] A mandibular advancement device is a device similar to a dental guard with the function of protecting teeth. When the patient sleeps, the mandibular advancement device is worn on the teeth. Its basic principle is to use the front-back dislocation fixation of the upper and lower parts of the device to move the patient's mandible (i.e., the mandibular bone) in the direction opposite to the tongue side, creating a larger space at the back of the throat to prevent airway obstruction caused by the backward displacement of the tongue side and the collapse of surrounding soft tissues during sleep. In addition, the mandibular advancement device only needs to be placed in the patient's mouth during sleep, does not stimulate the patient's skin or hair, and does not limit the patient's movement. It is simple, small and easy to carry. For some patients who are used to wearing a dental guard mandibular advancement device, the mandibular advancement device is a more acceptable treatment method compared to other treatment methods.

[0004] Although the mandibular advancement device has many advantages as mentioned above, in order to make the mandibular advancement device perfectly match the patient's teeth and jawbone, its manufacturing process needs to customize a model according to the patient's teeth or oral cavity. The customized mandibular advancement device uses advanced manufacturing equipment and a complete digital manufacturing process, which can enable the patient to have fewer side effects, but it is expensive and time-consuming. Therefore, the customized mandibular advancement device is not the best choice for the general public. Some other customized mandibular advancement devices still require the participation of professionals, increasing the patient's time cost. Summary of the Utility Model

[0005] Based on the above deficiencies, the utility model provides a mandibular advancement device that is convenient for patients to use, reduces the patient's usage cost and is comfortable to wear.

[0006] A mandibular advancement device with a supported baffle, comprising:

[0007] The upper tray assembly has an arched outer shape to conform to the dental arch curve of the patient;

[0008] The lower tray assembly has an arched outer shape to conform to the dental arch curve of the patient;

[0009] The upper tray assembly includes an upper plasticizable member and an upper bracket;

[0010] The lower tray assembly includes a lower plasticizable member and a lower bracket;

[0011] Wherein, the lower bracket has a support baffle, which is configured to be located on the lingual side of the lower bracket during use;

[0012] Wherein, the support baffle has a top edge and a bottom edge, and the angle range between the connection line of the intersections of the top edge and the bottom edge with any sagittal plane of the lower bracket and the horizontal plane is 20° - 150°.

[0013] In one embodiment, the arched shapes of the upper plasticizable member and the lower plasticizable member adopt at least one of an oval arch, a conical arch, and a square arch.

[0014] In one embodiment, the upper plasticizable member and the lower plasticizable member are respectively configured to at least partially conform to the upper dental arch and the lower dental arch of the patient during use.

[0015] In one embodiment, the length of the bottom edge of the support baffle is greater than 10% of the curve length of the whole lower bracket at the bottom edge.

[0016] In one embodiment, the upper plasticizable member and the lower plasticizable member are made of a flexible thermoplastic material.

[0017] In one embodiment, the hardness of the materials of the upper bracket and the lower bracket is at least partially greater than the hardness of the materials of the upper plasticizable member and the lower plasticizable member.

[0018] The present utility model also discloses a mandibular advancement device with a supported baffle, including:

[0019] An upper tray assembly, configured to be adjacent to the maxillary dental arch of the patient when positioned in the patient's oral cavity;

[0020] A lower tray assembly, configured to be adjacent to the mandibular dental arch of the patient when positioned in the patient's oral cavity;

[0021] The upper tray assembly includes an upper plasticizable member and an upper bracket;

[0022] The lower tray assembly includes a lower plasticizable member and a lower bracket;

[0023] Wherein, the lower bracket has a support baffle, which is configured to be located at a position close to the lingual side of the lower bracket during use;

[0024] Wherein, in the upward orthographic angle, the support baffle has a shadow surface, and the ratio of the area of the shadow surface to the area of the lower bracket in the upward orthographic view is less than or equal to 40%.

[0025] In one embodiment, the support baffle is divided into a plurality of spaced-apart portions.

[0026] In one embodiment, the lower plastically deformable member has a shape that engages and matches the support baffle.

[0027] In one embodiment, the upper plastically deformable member and the lower plastically deformable member are configured to soften after being heated so as to be adjusted and shaped to match the upper and lower dental arches of the patient when the patient bites.

[0028] In one embodiment, the upper plastically deformable member and the lower plastically deformable member are made of a plastically deformable material, and the temperature heated to the required deformation temperature is less than 100 degrees.

[0029] In one embodiment, the upper bracket and the lower bracket are made of a material with high temperature stability, and the temperature heated to the required deformation temperature is greater than 100 degrees.

[0030] The present utility model also discloses a mandibular advancement device with a supported baffle, including:

[0031] An upper tray assembly, configured to be adjacent to the upper dental arch of the patient when positioned in the patient's oral cavity;

[0032] A lower tray assembly, configured to be adjacent to the lower dental arch of the patient when positioned in the patient's oral cavity;

[0033] The upper tray assembly includes an upper plastically deformable member and an upper bracket;

[0034] The lower tray assembly includes a lower plastically deformable member and a lower bracket;

[0035] Wherein, the lower bracket has a support baffle, which is configured to be located at a position close to the lingual side of the lower bracket during use;

[0036] Wherein, in the upward orthographic angle, the support baffle has a shadow surface, and the ratio of the area of the shadow surface to the area of the lower bracket in the upward orthographic view is less than or equal to 40%;

[0037] Wherein, the support baffle is integrally in a form that is high in the middle and low on both sides.

[0038] In one embodiment, the upper bracket and the lower bracket are respectively configured to correspondingly engage and support the upper plastically deformable member and the lower plastically deformable member.

[0039] In one embodiment, a gear position adjustment module is provided between the upper bracket and the lower bracket.

[0040] In one embodiment, the gear position adjustment module has two or more adjustment gears.

[0041] In one embodiment, the maximum height of the support baffle is less than or equal to the maximum height of the lower plastically deformable member.

[0042] The present utility model also discloses a mandibular advancement device having a supported baffle, comprising:

[0043] An upper tray assembly having an arched outer shape to conform to the curve of the patient's upper dental arch;

[0044] A lower tray assembly having an arched outer shape to conform to the curve of the patient's lower dental arch;

[0045] The upper tray assembly includes an upper plastically deformable member and an upper bracket;

[0046] The lower tray assembly includes a lower plastically deformable member and a lower bracket;

[0047] Wherein, the lower bracket has a support baffle configured to be located at a position close to the lingual side of the lower bracket during use;

[0048] Wherein, the support baffle has one or more of the following features:

[0049] The support baffle has a top edge and a bottom edge, and the angle range between the connecting line of the intersection points of the top edge and the bottom edge with any sagittal plane of the lower bracket and the horizontal plane is 20° - 150°;

[0050] The length of the top edge of the support baffle is greater than or equal to 5 mm;

[0051] The thickness range of the support baffle is: 0.3 mm - 10 mm;

[0052] The vertical height of the support baffle is less than or equal to 15 mm;

[0053] The hardness range of the support baffle is Shore D45 - Shore D95.

[0054] In one embodiment, the top edge and the bottom edge of the support baffle have a continuous curvature.

[0055] In one embodiment, the upper tray assembly and the lower tray assembly are made of at least two different materials.

[0056] In one embodiment, the sum of the projected areas of the upper plastically deformable part and the lower plastically deformable part on the horizontal plane is greater than the sum of the projected areas of the upper bracket and the lower bracket on the horizontal plane.

[0057] In one embodiment, the lower plastically deformable part has a shape that engages and matches the support baffle.

[0058] The mandibular advancement device implementing the present utility model has at least the following beneficial effects:

[0059] 1) Using a mandibular advancement device to prevent or reduce snoring and / or obstructive sleep apnea during sleep is a better conservative therapy other than CPAP. There are various mandibular advancement devices with different designs in the existing market, which are classified into two types: plastically deformable mandibular advancement devices and non-plastically deformable mandibular advancement devices according to their adjustability and adaptability during use. The present technical utility model is a type of plastically deformable mandibular advancement device. A non-plastically deformable mandibular advancement device needs to be customized under the guidance of a professional doctor. Since it is customized, it can perfectly match the patient's teeth and oral conditions, so it can provide better comfort for the patient. However, precisely because this mandibular advancement device is customized and requires professional doctor guidance and adjustment, the treatment cost of the non-plastically deformable mandibular advancement device is relatively high, so its price is also expensive. For some groups of patients, the process of docking with and adjusting by the doctor and customization is relatively complex and troublesome. Compared with the non-plastically deformable mandibular advancement device, these patients and patients with limited budgets may be more inclined to purchase a plastically deformable mandibular advancement device. A plastically deformable mandibular advancement device allows the patient to perform bite shaping by simple heating, and its price is also relatively cheaper than the customized one, which is a more economical choice for most patients.

[0060] 2) Although malleable mandibular advancement devices are more likely to be chosen by most patients compared to non-malleable ones, they still have some significant problems and limitations. Currently, the patient evaluations of malleable mandibular advancement devices on the market are generally poor, with low patient satisfaction. The main reason is that their comfort and reliability still need to be improved. For example, the function of the lower tray component is mainly to pull the patient's mandible away from the lingual side. However, due to violating the inertial force, the patient's mandible exerts a force on the lower tray component in the opposite direction of the traction force of the mandibular advancement device. During the use of existing mandibular advancement devices without a supporting baffle on the market, since there is no structure to support the upper malleable component and the lower malleable component to counteract the force generated by the mandible on the lower malleable component. At this time, because the upper malleable component and the lower malleable component are made of flexible materials, this force easily causes the upper malleable component and the lower malleable component, especially the lower malleable component, to deform. The deformed lower malleable component causes the mandible to slide backward, resulting in the failure of the mandibular advancement device. In addition, some existing mandibular advancement devices are also prone to detachment at the joints of the upper bracket, the lower bracket, the upper malleable component, and the lower malleable component, especially the lower tray component. Moreover, the lower malleable component and the lower bracket of this device are only connected by a few relatively small snap structures, resulting in insecure fixation here. Also, due to the force exerted by the mandible on the lower malleable component and the fact that the lower malleable component is made of flexible materials, it is extremely easy for the snap structure to fall off and cause the lower malleable component to separate from the lower bracket. The utility model of the present technology, by comparing with the existing designs, innovatively proposes a mandibular advancement device with a supporting baffle, which can prevent the separation of the lower malleable component from the lower bracket. Compared with the existing mandibular advancement devices on the market, it makes it more convenient for patients during use and helps patients use it better. This innovative design solves the key problems in the existing technology and is an innovative and advantageous solution.

[0061] 3) For patients, the mandibular advancement device of the present utility model can not only prevent the displacement of the lower plasticizable component and the lower bracket, but also has an angle at the support baffle. Since the general gum and lower tooth parts are not in a vertical plane, this part has a sloping shape. The support baffle with an angle matches the slope of the gum and tooth parts, so that during use, the mandibular advancement device of the present utility model can fit the patient's oral cavity more closely, making the patient feel more comfortable. And comfort is an important reason for patients to choose to buy the device. If the device is not comfortable or affects the treatment during use, such as the situation of component detachment, it will cause the patient not to be willing to wear it for a long time, thus affecting the treatment. Therefore, the present utility model improves the patient's compliance to a certain extent and enables the patient's treatment to be more stable. In addition, the present utility model also makes the support baffle play a more effective role during the patient's use through reasonable regulations of various parameters. For example, by specifying the angle and height of the support baffle, controlling the angle of the support baffle within a certain range can adapt to most patient populations. The angle is set to 20° - 150°, preferably 45° - 90°, and its height is less than or equal to 15 mm. If the support baffle exceeds a certain angle outward or is too high, it is easy for the baffle to exceed the basic position and limit the occlusion of the upper and lower jaws. If the support baffle exceeds a certain angle inward or is too low, it is easy for the support baffle to lose its function. The present utility model also specifies the length of the support baffle according to the need. Since the actual growth form of the teeth and gums is high in the middle and low on both sides, and due to the patient's autonomous movement of the mandible in the lingual direction, the force acting on the lower tray assembly is mainly in the middle part. Therefore, setting the support baffle in the middle part of the lower bracket is the optimal layout. If the two sides are too long, they are actually ineffective action areas. In addition to the above data, setting the hardness of the support baffle is also a relatively important link. As long as the support baffle has no impact on the safety of the patient, the material of the support baffle is not specifically specified. Therefore, the support baffle can be made of any material that meets the safety regulations. However, to make the support baffle an effective structure in the mandibular advancement device, it is necessary to ensure its function of supporting the lower plasticizable component. Under this requirement, the hardness of the support baffle is required, and the hardness range of the support baffle is set to Shore D45 - Shore D95. Within this range, because a too hard support baffle is easy to scratch the patient's oral cavity, and a too soft support baffle cannot achieve the support function. Therefore, it is preferred to select a support baffle with a hardness range of Shore D65 - Shore D85 as a more suitable choice for use. And the data in the present utility model are all selected from the appropriate ranges through multiple measurements by professional instruments, which are scientific-based support baffles and can guarantee the effectiveness and comfort of the patient's use. By effectively designing the support baffle, it is different from the existing mandibular advancement devices and has better performance than the existing devices, bringing a better experience to the patient.

[0062] 4) For the product itself, the mandibular advancement device without a support baffle is prone to the detachment of the lower moldable component, and since the upper and lower moldable components are made of flexible materials, it is extremely easy to damage the upper and lower moldable components. The damage of the product not only reduces the service life of the mandibular advancement device, but also leads to the instability of the mandibular advancement device, thus weakening its therapeutic effect. However, the mandibular advancement device with a support baffle of the present utility model significantly improves the stability of the device by strengthening the fixation of the lower moldable component and the lower bracket. It can effectively prevent the pulling of the lower moldable component by two opposite forces, ensuring that the lower moldable component will not easily fall off or be damaged during use. This design not only makes the mandibular advancement device more durable, but also ensures the stability and reliability of its therapeutic effect. Description of the Drawings

[0063] Figure 1 It is an overall schematic diagram of the mandibular advancement device in an embodiment of the present utility model;

[0064] Figure 2 It is a top view of the upper tray assembly and the shape of the upper dental arch in multiple embodiments of the present utility model;

[0065] Figure 3 It is an exploded schematic diagram of the structure of the mandibular advancement device in an embodiment of the present utility model;

[0066] Figure 4 It is a top view of the upper moldable component and the upper bracket in an embodiment of the present utility model;

[0067] Figure 5 It is an overall schematic diagram of the lower bracket in Embodiment 1 of the present utility model;

[0068] Figure 6 It is a schematic diagram of the sliding of the lower moldable component and the lower bracket during use in an embodiment of the present utility model;

[0069] Figure 7 It is an exploded schematic diagram of the structure of the lower moldable component and the lower bracket in Embodiment 1 of the present utility model;

[0070] Figure 8 It is an overall schematic diagram of the mandibular advancement device with both upper and lower brackets having support baffles in Embodiment 1 of the present utility model;

[0071] Figure 9 It is a schematic diagram of the horizontal plane, sagittal plane, and coronal plane in multiple embodiments of the present utility model;

[0072] Figure 10 It is an overall schematic diagram and cross-sectional schematic diagram of the intersection of the lower bracket and any sagittal plane in Embodiment 1 of the present utility model;

[0073] Figure 11 Schematic diagram of the lower tray assembly biting with the mandible in the first embodiment of the present utility model;

[0074] Figure 12 Schematic diagram of the lower tray assembly with support baffles at different angles during use in the first embodiment of the present utility model;

[0075] Figure 13 Overall schematic diagram of the lower bracket regarding the data of the support baffle in the first embodiment of the present utility model;

[0076] Figure 14 Overall schematic diagram of the lower bracket with support baffles in different forms in another embodiment of the first embodiment of the present utility model;

[0077] Figure 15 Top view of the lower bracket in another embodiment of the first embodiment of the present utility model;

[0078] Figure 16 Overall schematic diagram of the lower bracket with support baffles in different forms in the second embodiment of the present utility model;

[0079] Figure 17 Schematic diagram of the hardness test of the support baffle in multiple embodiments of the present utility model. Detailed implementation manners

[0080] To make the above objects, features, and advantages of the present utility model more obvious and understandable, the following will describe the detailed implementation manners of the present utility model in conjunction with the drawings. Many specific details are set forth in the following description to fully understand the present utility model. However, the present utility model can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present utility model. Therefore, the present utility model is not limited by the specific embodiments disclosed below.

[0081] Compared with the mandibular advancement device 1 in the existing market, the present utility model innovatively proposes the structure of the support baffle 33. Through the design and use of the support baffle 33, the performance of the mandibular advancement device 1 is maximized, thereby improving the effectiveness of the mandibular advancement device 1 and the comfort of the patient during use, making it reach a better state in terms of effectiveness, comfort, reliability, and service life. Therefore, the mandibular advancement device 1 of the present utility model not only improves the performance indicators but also brings a more stable, safe, and comfortable use experience to the patient.

[0082] The present utility model provides a mandibular advancement device 1 that is convenient for patients to use, reduces the patient's usage cost, and is comfortable to wear.

[0083] Specifically, please refer to Figures 1 to 6, the mandibular advancement device 1 of the present utility model includes an upper tray assembly 2 and a lower tray assembly 3. Among them, the upper tray assembly 2 has a generally arched external shape to conform to the curve of the patient's upper dental arch and is configured to be adjacent to the patient's maxillary dentition when positioned in the patient's oral cavity. The lower tray assembly 3 has a generally arched external shape to conform to the curve of the patient's lower dental arch and is configured to be adjacent to the patient's mandibular dentition when positioned in the patient's oral cavity. Among them, the upper deformable member 21 and the lower deformable member 31 are respectively configured to partially conform to the patient's upper teeth and lower teeth during use, and the shape of the patient's dental arch curve can be roughly divided into various shapes such as oval arch, conical arch, and square arch. Therefore, the arched shapes of the upper deformable member 21 and the lower deformable member 31 adopt at least one of the oval arch, conical arch, and square arch (such as Figure 2 as shown). And, the upper and lower tray assemblies 2 and 3 can be composed of two completely separate parts, or the upper and lower tray assemblies 2 and 3 can be connected by a hinge or any other means to form an inseparable whole.

[0084] Further, the upper tray assembly 2 includes an upper deformable member 21 and an upper bracket 22, and the lower tray assembly 3 includes a lower deformable member 31 and a lower bracket 32. The upper deformable member 21 and the lower deformable member 31 can be detachably engaged with the upper bracket 22 and the lower bracket 32, or can be fixedly non-detachable. The form of detachable engagement here includes protrusions, snap-fits in the form of grooves, and / or additional components such as pins, screws, dowels, magnets, etc. For better fixing effect and the convenience of the mandibular advancement device 1, it is preferred that the connection between the upper deformable member 21 and the lower deformable member 31 and the upper bracket 22 and the lower bracket 32 is a snap connection. Here, the snap connection generally means that the upper deformable member 21 and the lower deformable member 31 have protrusions that respectively match the grooves on the upper bracket 22 and the lower bracket 32, or it can also be that the upper bracket 22 and the lower bracket 32 have protrusions that match the grooves on the upper deformable member 21 and the lower deformable member 31. And the protrusions and grooves are symmetrically distributed on the adjacent two sides and both ends of the middle part (i.e., the position of the mandibular advancement device 1 close to the patient's front teeth), that is, at one end of the mandibular advancement device 1 close to the patient's temporomandibular joint). In addition, in order to prevent the separation of the components of the upper and lower tray assemblies 2 and 3 during the patient's use to ensure effective treatment, the connection between the upper and lower trays during the patient's use is mainly formed by the upper bracket 22 and the lower bracket 32. The upper bracket 22 and the lower bracket 32 are respectively configured to engage and support the upper deformable member 21 and the lower deformable member 31. Usually, the upper bracket 22 and the lower bracket 32 are snap-fixed, and the specific form of the snap is that there is at least one protrusion between the upper bracket 22 and the lower bracket 32 and a groove for accommodating the protrusion. The fixing here can also adopt various forms other than snap-fits, including but not limited to: threaded connection, hook connection, piston connection, welding connection, plug connection, dowel connection, adhesive connection, spring connection, mortise and tenon connection, or elastic band connection, etc. The connection method can adopt one form, or even can combine two or more forms. Selecting the appropriate connection method depends on specific design requirements, material properties, and usage environment to ensure firm, reliable, and durable connection, and it is necessary to facilitate installation during production and convenient adjustment operation for the patient.

[0085] The main usage process of the mandibular advancement device 1 is as follows: The upper moldable component 21 is joined with the upper bracket 22 to form the upper tray assembly 2, and the lower moldable component 31 is joined with the lower bracket 32 to form the lower tray assembly 3. By moving the relative positions between the upper and lower tray assemblies 2 and 3, the patient's mandible is pulled in a direction away from the tongue side to open the patient's airway. The movement of the relative positions between the upper and lower tray assemblies 2 and 3 here is achieved by adjusting the upper bracket 22 and the lower bracket 32, that is, there is a gear adjustment module 4 between the upper bracket 22 and the lower bracket 32. The gear adjustment module 4 has two or more adjustment gears, and the patient can select a suitable adjustment gear according to their own wearing comfort. The gear adjustment module 4 can have various forms, generally set at positions of the upper bracket 22 and the lower bracket 32 close to the tongue side. In some special cases, it is also allowed to set the gear adjustment module 4 at other positions. The gear adjustment module 4 can be in the form that the upper bracket 22 has a protrusion to cooperate with the groove of the lower bracket 32, or in the form that the lower bracket 32 has a protrusion to cooperate with the groove of the upper bracket 22. In some other cases, the gear adjustment module 4 can also be in the form of a non-protrusion and non-groove snap. Obviously, the gear adjustment module 4 can also be in a non-snap form. There can be multiple fixed connections between the upper bracket 22 and the lower bracket 32 in addition to the gear adjustment module 4 to additionally fix the upper bracket 22 and the lower bracket 32; or it can be that only the gear adjustment module 4 is responsible for fixing the upper bracket 22 and the lower bracket 32.

[0086] In the present utility model, the sizes of the upper moldable component 21, the lower moldable component 31, the upper bracket 22, and the lower bracket 32 are also limited. The projected areas of the upper moldable component 21 and the lower moldable component 31 on the horizontal plane are larger than the projected areas of the upper bracket 22 and the lower bracket 32 on the horizontal plane (as Figure 4 shown), to provide greater comfort and adjustability. First, the upper moldable component 21 and the lower moldable component 31 are made of materials more flexible than the upper bracket 22 and the lower bracket 32, which can further reduce the irritation and scratching of oral soft tissues. Second, considering the differences in the distances from the inner side of the lips to the retromolar area of different patients, an overly long device may cause scratching of the oral tissues in the retromolar area. Especially in the area where the joint is located, it may affect the occlusal function. For some people with inappropriate sizes of the upper moldable component 21 and the lower moldable component 31, they can be trimmed according to personal needs and preferences to adjust the length, improving the wearing comfort and personalized adaptability. This design not only ensures the functionality of the mandibular advancement device 1, but also gives patients more autonomy in adjustment. And, based on this principle, the maximum height of the support baffle 33 is also designed to be less than or equal to the maximum height of the lower moldable component 31 to prevent the irritation and scratching of oral soft tissues.

[0087] The material selection range of the upper tray assembly 2 and the lower tray assembly 3 is extensive. Since the upper plasticizable component 21 and the lower plasticizable component 31 are the components that mainly come into contact with the patient's teeth and part of the gums during use, and the upper bracket 22 and the lower bracket 32 play a role of support, fixation and positioning in the mandibular advancement device 1, therefore, the upper tray assembly 2 and the lower tray assembly 3 are made of at least two different materials, so that the hardness of the materials of the upper bracket 22 and the lower bracket 32 is at least partially greater than the hardness of the materials of the upper plasticizable component 21 and the lower plasticizable component 31, wherein the hardness of the materials of the upper bracket 22 and the lower bracket 32 is between Shore D45 and Shore D95. In some other cases, the upper tray assembly 2 and the lower tray assembly 3 also use a single material to obtain different material rigidities by special manufacturing methods. When selecting the materials for the mandibular advancement device 1, various factors such as its biocompatibility, durability, functional stability, patient comfort, and ease of cleaning are widely considered, and plastic or polymer materials suitable for dental medical devices and can be molded are selected. These materials include but are not limited to polypropylene (PP), polycarbonate (PC), polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polyphenyl sulfone (PPSU), polyethylene (PE), high-density polyethylene (HDPE), low-density polyethylene (LDPE), ethylene-vinyl acetate copolymer (EVA), thermoplastic polyurethane (TPU), styrene-ethylene-butene-styrene (SEBS), styrene-ethylene-styrene (SEPS), silicone rubber, etc.

[0088] Among them, the upper plasticizable component 21 and the lower plasticizable component 31 are made of plasticizable materials, and the heating temperature to the deformation required temperature is less than 100 degrees. The upper bracket and the lower bracket are made of materials with high-temperature stability, and the heating temperature to the deformation required temperature is greater than 100 degrees. Specifically, the upper plasticizable component 21 and the lower plasticizable component 31 are made of flexible thermoplastic materials. The upper plasticizable component 21 and the lower plasticizable component 31 are configured to be softened after heating, so as to be adjusted and molded into a shape matching the patient's upper and lower dental arches when the patient bites. During use, the patient only needs to put the upper and lower tray assemblies 2 and 3 into hot water for heating, and then gently bite the upper and lower tray assemblies 2 and 3 with the mouth, so that the upper and lower tray assemblies 2 and 3 form a good fit with the teeth, thereby shaping the heated upper plasticizable component 21 and lower plasticizable component 31 by biting to achieve a fit with the dental arch. The flexible thermoplastic material has a certain flexibility and can withstand repeated mechanical stresses without failure, which is very important for the situation where the patient needs to bite the plasticizable component of the mandibular advancement device 1 with the teeth during use. In addition, the flexible thermoplastic material also has the advantages of light weight and environmental protection.

[0089] The upper support 22 and the lower support 32 need to be made of materials that are more stable than the upper moldable member 21 and the lower moldable member 31. They need to have high-temperature stability and be able to maintain their original shape after shaping to provide structural support for the mandibular advancement device 1. Generally, the upper support 22 and the lower support 32 need to maintain their shape unchanged after long-term use. Therefore, they are made of materials that are more durable than the upper moldable member 21 and the lower moldable member 31. If the upper support 22 and the lower support 32 also use thermoplastic materials, their deformation temperature will be higher than that of the upper moldable member 21 and the lower moldable member 31, which can ensure that the upper support 22 and the lower support 32 will not be affected during the shaping process of the upper moldable member 21 and the lower moldable member 31.

[0090] The following describes several structures of the mandibular advancement device 1 of the present utility model with specific examples.

[0091] Embodiment 1

[0092] The mandibular advancement device 1 of this embodiment includes: an upper tray assembly 2 having a generally arched outer shape to conform to the curve of the patient's upper dental arch; a lower tray assembly 3 having a generally arched outer shape to conform to the curve of the patient's lower dental arch. The upper tray assembly 2 includes an upper moldable member 21 and an upper support 22; the lower tray assembly 3 includes a lower moldable member 31 and a lower support 32.

[0093] Among them, the lower support 32 has a support baffle 33, which is configured to be located at a position close to the lingual side of the lower support 32 during use. Among them, the support baffle 33 has a top edge 331 and a bottom edge 332 (as Figure 5 shown).

[0094] Since the main function of the mandibular advancement device 1 is to traction the patient's mandible forward (away from the lingual side), and due to habit, the patient's mandible will generate a force that retracts backward (towards the lingual side) on the lower moldable member 31. And since the lower moldable member 31 is made of a flexible material, it is very easy to cause the lower moldable member 31 to have excessive deformation or the front-back dislocation or separation between the lower support 32 and the lower moldable member 31 to occur (as Figure 6As shown). The provision of the support baffle 33 helps to provide the lower plastic component 31 with a force to resist deformation so as to maintain its original shape, and to fix the lower plastic component 31 and the lower bracket 32 ​​of the mandibular advancement device 1, thereby preventing the lower plastic component 31 and the lower bracket 32 ​​from falling off during use due to mechanical stress or usage habits. The stable and firm connection between the lower bracket 32 ​​and the lower plastic component 31 can continuously and effectively pull the mandible forward, thereby preventing airway obstruction caused by failure of the mandibular advancement device 1 during the patient's sleep. This directly affects the therapeutic effect of the mandibular advancement device 1, and the mandibular advancement device 1 with the support baffle 33 can more effectively alleviate the symptoms of obstructive sleep apnea syndrome. In some cases, the lower plastic component 31 has a shape that engages and matches with the support baffle 33 (such as Figure 7 As shown), the volume and comfort of use of the mandibular advancement device 1 are optimized. Specifically, the lower plastic component 31 fits closely with the shape of the support baffle 33, so that the volume of the lower tray assembly 3 will not increase due to the addition of the support baffle 33. This tightly fitting design not only ensures the stability of the assembly when worn, but also effectively reduces the occurrence of foreign body sensation in the oral cavity. The support baffle 33 can be set on only one of the upper support 22 and the lower support 32. The preferred option is to set it on the lower support 32. Obviously, the support baffle 33 can also be set on both the upper support 22 and the lower support 32 (as shown in FIG. 2 ). Figure 8 shown).

[0095] The support stop in this embodiment is inclined. The support baffle 33 is designed according to the shape of the mandible to provide better fit and support, further improving the patient's comfort. In this embodiment, the angle between the line connecting the top edge 331 and the bottom edge 332 and any sagittal plane intersection of the lower bracket 32 ​​and the horizontal plane is set to 20°-150°, wherein 45°-90° is preferably a more comfortable angle range (such as Figure 9 , Figure 10 As shown in FIG. 1 , the angle setting here is to better improve the comfort of the patient. Since the lower tray assembly 3 and the patient's mandible are engaged when the mandibular advancement device 1 is used (as shown in FIG. 1 ), the lower tray assembly 3 and the patient's mandible are engaged when the mandibular advancement device 1 is used. Figure 11 The angle of inclination toward the lingual side helps to better match the lower tray assembly 3 with the patient's mandible (as shown in FIG. Figure 12 The angle of the tongue away from the tongue is easy to hit the patient's teeth and gums (as shown in Figure A). Figure 12As shown in B, the stress formed at the sharp corners of the lower malleable component 31 can easily make the patient feel uncomfortable during the treatment process. To enable the support baffle 33 to play a role during the patient's use, the length of the bottom edge 332 of the support baffle 33 is set to be greater than 10% of the curve length of the entire lower bracket 32 at the bottom edge 332. Also, it is optimal to arrange the support baffle 33 in the middle part of the lower bracket. Since the overall shape of the lower bracket 32 is arched, if the two sides are too long, the two side parts are actually ineffective action areas. Considering the length of the lower bracket 32 of the existing mandibular advancement device 1 on the market, in this embodiment, it is a better range that the length of the support baffle 33 is greater than or equal to 5 mm (such as Figure 13 as shown in d1). And due to the limitations of its material and size, the thickness range of the support baffle 33 is set to be: 0.3 mm - 10 mm (such as Figure 13 as shown in d2) to provide support for the malleable part within a suitable range. The setting of the support baffle 33 generally does not exceed the gum end of the patient, so the height of the support baffle 33 is set to be less than or equal to 15 mm (such as Figure 13 as shown in d3). In addition to the above data, it is also necessary to stipulate the hardness of the support baffle 33. Since no specific restrictions are imposed on the material of the support baffle 33 in this embodiment, as long as the material used to make the support baffle 33 is harmless to the patient's health, the support baffle 33 can be made of any material. However, to enable the support baffle 33 to achieve the function of supporting the lower malleable component 31 during use, it is necessary to limit the hardness of the support baffle 33. An overly hard support baffle 33 is likely to scratch the patient's oral cavity, while an overly soft support baffle 33 cannot achieve the support effect. In this embodiment, after multiple repeated tests, the support baffles 33 with different hardness ranges are measured through professional instruments, and the hardness range of the support baffle 33 is set to be Shore D45 - Shore D95. Among them, it is preferred that the support baffle 33 with Shore D65 - Shore D85 is the most suitable choice for effectiveness and comfort. In addition, since the shapes of the lower teeth and gums themselves gradually decrease from the middle to both sides, therefore, to better fit the patient's oral cavity, the support baffle 33 is also set to be in the form of higher in the middle and lower at both sides (such as Figure 14 as shown in A). At this time, in one case, the top edge 331 and the bottom edge 332 of the support baffle 33 have a continuous curvature. Obviously, the top edge 331 of the support baffle 33 can also have a discontinuous curvature. In addition, the length of the support baffle 33 can also be adjusted according to the actual situation and can be in a longer or shorter form (such as Figure 14 as shown in B).

[0096] In some other embodiments, in the upward orthogonal view, the support baffle 33 has a shadow surface, and the ratio of the area of this shadow surface to the area of the lower bracket 32 in the upward orthogonal view is less than or equal to 40% (such as Figure 15As shown. The angle between the connecting line of the intersection points of the top edge 331 and the bottom edge 332 of the support baffle 33 and any sagittal plane of the lower bracket 32 and the horizontal plane is less than 90°, and the support baffle 33 can only tilt in the lingual direction. This method conforms to the ramp angle of the lower teeth and gums on the premise of ensuring the structural effectiveness of the support baffle 33, and ensures the comfort of the patient when wearing.

[0097] In some other embodiments, the support baffle 33 is in the form that the top edge 331 is on the same horizontal plane and extends vertically to the bottom edge 332 at a certain position to form two side edges. And, the support baffle 33 can have different lengths (such as Figure 14 shown in C).

[0098] Embodiment 2

[0099] The mandibular advancement device 1 of this embodiment includes: an upper tray assembly 2 having a generally arched external shape to conform to the curve of the patient's upper dental arch; a lower tray assembly 3 having a generally arched external shape to conform to the curve of the patient's lower dental arch. The upper tray assembly 2 includes an upper moldable member 21 and an upper bracket 22; the lower tray assembly 3 includes a lower moldable member 31 and a lower bracket 32.

[0100] Among them, the lower bracket has a support baffle 33, which is configured to be located at a position close to the lingual side of the lower bracket 32 during use.

[0101] The difference between this embodiment and Embodiment 1 is that: the support baffle 33 is divided into a plurality of spaced-apart parts, and the support baffle 33 is not a continuous integral body but has a structure with discontinuous walls, but its function remains unchanged (such as Figure 16 shown). The discontinuous walls reduce the material usage of the support baffle 33 to a certain extent, making the entire device lighter and more comfortable to wear. And the structure of the discontinuous walls increases the flexibility of the mandibular advancement device 1, enabling it to better adapt to the shape and movement of the patient's mandible, and reducing the pressure feeling of the support baffle 33 on the oral cavity and teeth during wearing. If the angle of the support baffle 33 at the factory is not the optimal wearing comfort angle for the patient, the discontinuous support baffle 33 can be adjusted more flexibly according to the patient's oral structure to achieve personalized adaptation. This adjustability ensures that each patient can find the most suitable wearing angle and size for themselves, further improving the wearing comfort and treatment effect. In addition, the structure of the discontinuous walls also brings additional advantages, such as enhancing the breathability of the device and being able to reduce the stuffy feeling during wearing.

[0102] In addition, the technical features in the above embodiments can be combined as needed to obtain a mandibular advancement device 1 including all or part of the above technical features.

[0103] Implementing the mandibular advancement device 1 with a foam pad of the present utility model has at least the following beneficial effects:

[0104] 1) Using a mandibular advancement device to prevent or reduce snoring and / or obstructive sleep apnea during sleep is a better conservative therapy other than CPAP. There are various mandibular advancement devices with different designs in the existing market, which are classified into two types: moldable mandibular advancement devices and non-moldable mandibular advancement devices according to their adjustability and adaptability during use. The present technical utility model is one of the moldable mandibular advancement devices. Non-moldable mandibular advancement devices need to be customized according to the guidance of professional physicians. Since they are customized, they can perfectly match the patient's teeth and oral conditions, so they can provide better comfort for patients. However, precisely because this mandibular advancement device is customized and requires professional physicians to guide and adjust, the treatment cost of non-moldable mandibular advancement devices is relatively high, so their prices are also expensive. For some groups of patients, the process of docking with physicians, adjusting, and customization is relatively complex and troublesome. Compared with non-moldable mandibular advancement devices, these patients and patients with limited budgets may be more inclined to purchase moldable mandibular advancement devices. Moldable mandibular advancement devices allow patients to perform occlusal shaping by simple heating, and their prices are also relatively cheaper than customized ones, which is a more economical choice for most patients.

[0105] 2) Although the malleable mandibular advancement device 1 is more likely to be chosen by most patients compared to the non-malleable mandibular advancement device 1, it still has some significant problems and limitations. Currently, the patient evaluations of the malleable mandibular advancement device 1 on the market are generally poor, and the patient satisfaction is low. The main reason is that its comfort and reliability still need to be improved. For example, the main function of the lower tray assembly 3 is to pull the patient's mandible away from the lingual side. However, due to violating the inertial force, the patient's mandible generates a force on the lower tray assembly 3 in the opposite direction of the traction force of the mandibular advancement device 1. In the existing mandibular advancement device 1 without the support baffle 33 on the market during use, since there is no structure to support the upper malleable part 21 and the lower malleable part 31 to resist the force generated by the mandible on the lower malleable part 31. At this time, because the upper and lower malleable parts 21 and 31 are made of flexible materials, this force easily causes the upper malleable part 21 and the lower malleable part 31, especially the lower malleable part 31, to deform. The deformed lower malleable part 31 causes the mandible to slide backward, resulting in the failure of the function of the mandibular advancement device 1. In addition, in some existing mandibular advancement devices 1, the connections between the upper bracket 22, the lower bracket 32, the upper malleable part 21, and the lower malleable part 31 are also prone to detachment, especially the lower tray assembly 3. Moreover, the lower malleable part 31 and the lower bracket 32 of this device 1 are only connected by a few relatively small snap structures, resulting in insecure fixation here. Also, due to the force generated by the mandible on the lower malleable part 31 and the fact that the lower malleable part 31 is made of flexible materials, it is extremely easy for the snap structure to fall off and cause the lower malleable part 31 to separate from the lower bracket 32. And through comparison with the existing design, the present utility model innovatively proposes a mandibular advancement device 1 with a support baffle 33, which can prevent the separation of the lower malleable part from the lower bracket. Compared with the existing mandibular advancement devices 1 on the market, it makes it more convenient for patients during use and helps patients use it better. This innovative design solves the key problems in the existing technology and is an innovative and advantageous solution.

[0106] 3) For patients, the mandibular advancement device 1 of the present utility model can not only prevent the displacement of the lower moldable part 31 and the lower bracket 32, but also the mandibular advancement device 1 of the present utility model has an angle at the support baffle 33. Since the general gum and lower tooth parts are not vertical planes, this part has a sloping shape, and the support plate with an angle matches the slope of the gum and tooth parts, so that during use, the mandibular advancement device 1 of the present utility model can fit the patient's oral cavity more closely and make the patient feel more comfortable. And comfort is an important reason for patients to choose to buy the device. If the device is not comfortable or affects the treatment during use by the patient, such as the situation of component detachment, it will cause the patient not to be willing to wear it for a long time, thus affecting the treatment. Therefore, the present utility model improves the patient's compliance to a certain extent and enables the patient's treatment to be more stable. In addition, the present utility model also makes the support baffle 33 play a more effective role during the patient's use through reasonable regulations of various parameters. For example, by specifying the angle and height of the support baffle 33, controlling the angle of the support baffle 33 within a certain range can adapt to most patient populations, setting its optimal angle to be 20° - 150°, preferably 45° - 90°, and its height less than or equal to 15 mm. If the support baffle 33 exceeds a certain angle outward or is too high, it is easy for the baffle to exceed the basic position and limit the occlusion of the upper and lower jaws, while if the support baffle 33 exceeds a certain angle inward or is too low, it is easy for the support baffle 33 to lose its function. The present utility model also specifies the length of the support baffle 33 as required. Since the actual growth form of the teeth and gums is higher in the middle and lower on both sides, and due to the patient's mandibular autonomous movement in the lingual direction, the force acting on the lower tray assembly 3 is mainly in the middle part. Therefore, setting the support baffle 33 in the middle part of the lower bracket 32 is the optimal layout method. If the two sides are too long, it is actually an ineffective action area. In addition to the above data, setting the hardness of the support baffle 33 is also a relatively important link. As long as the support baffle 33 has no impact on the safety of the patient, the material of the support baffle 33 is not specifically specified. Therefore, the support baffle 33 can be made of any material that meets the safety regulations. However, to make the support baffle 33 an effective structure in the mandibular advancement device, it is necessary to ensure its function of supporting the lower moldable part 31. Under this requirement limitation, requirements are made for the hardness of the support baffle 33, and the hardness range of the support baffle 33 is set to Shore D45 - Shore D95. Within this range, since an overly hard support baffle 33 is easy to scratch the patient's oral cavity, and an overly soft support baffle 33 cannot achieve the support function. Therefore, it is preferred to select a support baffle 33 with a hardness range of Shore D65 - Shore D85 as a more suitable choice for use. And the data in the present utility model content are all selected from the appropriate ranges after being measured by professional instruments multiple times and compared, and are scientific-based support baffles, which guarantee the effectiveness and comfort of the patient's use.By effectively designing the support baffle 33, it is different from the existing mandibular advancement device 1 and has better performance than the existing device, bringing a better experience to patients.

[0107] 4) For the product itself, the mandibular advancement device 1 without the support baffle 33 is likely to cause the shedding of the lower moldable part 31, and since the upper and lower moldable parts are made of flexible materials, it is very easy to damage the upper and lower moldable parts. The damage of the product not only reduces the service life of the mandibular advancement device 1 but also leads to the instability of the mandibular advancement device 1, thus weakening its therapeutic effect. However, for the mandibular advancement device 1 with the support baffle 33 of the present utility model, by strengthening the fixation of the lower moldable part 31 and the lower bracket 32, the stability of the device is significantly improved. It can effectively prevent the pulling of the lower moldable part by two opposite forces, ensuring that the lower moldable part 31 will not easily fall off or be damaged during use. This design not only makes the mandibular advancement device 1 more durable but also ensures the stability and reliability of its therapeutic effect.

[0108] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as within the scope described in this specification.

[0109] The above-described embodiments only represent several implementation manners of the present utility model. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the utility model patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present utility model, several modifications and improvements can still be made, and these all belong to the protection scope of the present utility model. Therefore, the protection scope of the utility model patent shall be subject to the appended claims.

Claims

1. A mandibular advancement device with a support baffle, characterized in that Comprising: An upper tray assembly having an external shape that is arched to conform to the curve of the patient's maxillary dentition; A lower tray assembly having an external shape that is arched to conform to the curve of the patient's mandibular dentition; The upper tray assembly includes an upper moldable member and an upper bracket; The lower tray assembly includes a lower moldable member and a lower bracket; Wherein, the lower bracket has a support baffle configured to be located at a position close to the lingual side of the lower bracket during use; Wherein, the support baffle has a top edge and a bottom edge, and the angle between the line connecting the intersection points of the top edge and the bottom edge with any sagittal plane of the lower bracket and the horizontal plane ranges from 20° to 150°.

2. The mandibular advancement device according to claim 1, wherein, The arched shapes of the upper moldable member and the lower moldable member adopt at least one of an oval arch, a conical arch, and a square arch.

3. The mandibular advancement device according to claim 1, characterized in that, The upper moldable member and the lower moldable member are respectively configured to at least partially conform to the patient's upper dentition and lower dentition during use.

4. The mandibular advancement device according to claim 1, characterized in that, The length of the bottom edge of the support baffle is greater than 10% of the curve length of the entire lower bracket at the bottom edge.

5. The mandibular advancement device according to claim 1, wherein The upper moldable member and the lower moldable member are made of a flexible thermoplastic material.

6. The mandibular advancement device according to claim 1, wherein The hardness of the materials of the upper bracket and the lower bracket is at least partially greater than the hardness of the materials of the upper moldable member and the lower moldable member.

7. A mandibular advancement device with a support baffle, characterized in that, Comprising: An upper tray assembly configured to be adjacent to the patient's maxillary dentition when positioned in the patient's oral cavity; A lower tray assembly configured to be adjacent to the patient's mandibular dentition when positioned in the patient's oral cavity; The upper tray assembly includes an upper moldable member and an upper bracket; The lower tray assembly includes a lower moldable member and a lower bracket; Wherein, the lower bracket has a support baffle configured to be located at a position close to the lingual side of the lower bracket during use; Wherein, in the upward orthogonal angle, the support baffle has a shaded surface, and the ratio of the area of the shaded surface to the area of the lower bracket in the upward orthogonal view is less than or equal to 2:

5.

8. The mandibular advancement device according to claim 7, wherein The support baffle is divided into a plurality of spaced-apart portions.

9. The mandibular advancement device according to claim 7, wherein The lower moldable member has a shape that engages and matches the support baffle.

10. The mandibular advancement device according to claim 7, wherein, The upper moldable member and the lower moldable member are configured to be softened after heating so as to be adjusted and molded into shapes that respectively match the patient's upper and lower dentitions when the patient bites.

11. The mandibular advancement device according to claim 7, characterized in that, The upper moldable member and the lower moldable member are made of a plastic material, and the heating temperature required for deformation is less than 100 degrees.

12. The mandibular advancement device according to claim 11, wherein, The upper bracket and the lower bracket are made of a material with high-temperature stability, and the heating temperature required for deformation is greater than 100 degrees.

13. A mandibular advancement device with a support baffle, characterized in that, Comprising: An upper tray assembly configured to be adjacent to the patient's maxillary dentition when positioned in the patient's oral cavity; A lower tray assembly configured to be adjacent to the patient's mandibular dentition when positioned in the patient's oral cavity; The upper tray assembly includes an upper moldable member and an upper bracket; The lower tray assembly includes a lower moldable member and a lower bracket; Wherein, the lower bracket has a support baffle configured to be located at a position close to the lingual side of the lower bracket during use; Wherein, in the upward orthogonal angle, the support baffle has a shaded surface, and the ratio of the area of the shaded surface to the area of the lower bracket in the upward orthogonal view is less than or equal to 2:5; Among them, the support baffle is in a form that is high in the middle and low on both sides as a whole.

14. The mandibular advancement device according to claim 13, wherein, The upper bracket and the lower bracket are respectively configured to correspondingly engage and support the upper plastically deformable component and the lower plastically deformable component.

15. The mandibular advancement device according to claim 13, wherein, A gear position adjustment module is provided between the upper bracket and the lower bracket.

16. The mandibular advancement device according to claim 15, characterized in that, The gear position adjustment module has two or more adjustment gear positions.

17. The mandibular advancement device according to claim 13, characterized in that, The maximum height of the support baffle is less than or equal to the maximum height of the lower plastically deformable component.

18. A mandibular advancement device with a support baffle, characterized in that, Including: An upper tray assembly having an arched outer shape to conform to the maxillary dentition curve of the patient; A lower tray assembly having an arched outer shape to conform to the mandibular dentition curve of the patient; The upper tray assembly includes an upper plastically deformable component and an upper bracket; The lower tray assembly includes a lower plastically deformable component and a lower bracket; Among them, the lower bracket has a support baffle, which is configured to be located at a position close to the lingual side of the lower bracket during use; Among them, the support baffle has one or more of the following characteristics: The support baffle has a top edge and a bottom edge, and the angle range between the connection line of the intersection points of the top edge and the bottom edge with any sagittal plane of the lower bracket and the horizontal plane is 20° - 150°; The length of the top edge of the support baffle is greater than or equal to 5 mm; The thickness range of the support baffle is: 0.3 mm - 10 mm; The vertical height of the support baffle is less than or equal to 15 mm; The hardness range of the support baffle is Shore D45 - Shore D95.

19. The mandibular advancement device according to claim 18, wherein, The top edge and the bottom edge of the support baffle have a continuous curvature.

20. The mandibular advancement device according to claim 18, wherein The upper tray assembly and the lower tray assembly are made of at least two different materials.

21. The mandibular advancement device according to claim 18, wherein, The sum of the projected areas of the upper plastically deformable component and the lower plastically deformable component in the horizontal plane is greater than the sum of the projected areas of the upper bracket and the lower bracket in the horizontal plane.

22. The mandibular advancement device according to claim 18, wherein The lower plastically deformable component has a shape that engages and matches the support baffle.

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