Lower jaw advancing device with stable structure

Abstract

The utility model relates to a mandibular advancement device with a stabilizing structure. The mandibular advancement device comprises an upper tray assembly and a lower tray assembly, wherein the upper tray assembly is formed by an upper moldable part and an upper support, and the lower tray assembly is formed by a lower moldable part and a lower support. The front side edges, close to the lip side, of the upper support and the lower support extend to form a front wall, and at least the rear side edge, close to the tongue side, of the lower support extends to form a rear wall on the median sagittal plane. The stabilizing structure enables at least the front wall of the upper support to incline towards the lingual side and is used for being attached to the maxillary dentition when the patient is shaped. The rear wall of the lower support and the front wall clamp the mandibular dentition together and also have the function of preventing the lower moldable component from sliding off. In some cases, the stabilizing structure further comprises a molar clamping part, the molar clamping part at least comprises a front wall and a rear wall at the contact position of the upper bracket and the molar, and the mandibular advancement device is more stable through the design of the front wall and the rear wall of the part. The lower jaw advancing device is further provided with protrusions on the upper support and the lower support.

Description

TECHNICAL FIELD

[0001] The utility model relates to a kind of mandibular advancement device with stable structure, by the design of mandibular advancement device makes it can be stabilized in patient oral cavity when patient sleeps not easy to fall, increase the sleep comfort and treatment compliance of patient. BACKGROUND

[0002] Sleep apnea (OSA) is a common sleep disorder in modern society, which is characterized by repeated apnea and hypopnea events during sleep. This disease is extremely harmful to people's physical and mental health, and can even lead to depression, mania, bipolar disorder and schizophrenia and other complications.

[0003] Snoring is likely to be a symptom of sleep apnea, and it may not just be a harmless habit. If snoring is accompanied by symptoms such as apnea, daytime sleepiness, and frequent nighttime awakenings, it is recommended to seek medical evaluation and diagnosis promptly to take appropriate treatment measures to improve sleep quality and overall health. Preventing and treating snoring and / or sleep apnea has become an urgent problem.

[0004] Mandibular advancement device is a treatment device designed specifically to address symptoms such as sleep apnea during sleep. The treatment principle of mandibular advancement device is: mandibular advancement device is usually divided into upper and lower parts, and the patient's mandible is migrated forward by the mispositioning of the upper and lower parts. Patients need to choose the appropriate mandibular adjustment stop before treatment, and place the mandibular advancement device with the appropriate stop in their mouth during sleep to increase the cross-sectional area of the upper airway, thereby maintaining the openness of the airway during sleep, preventing airway collapse and obstruction, and improving the patient's breathing. The existing mandibular advancement device is divided into customized mandibular advancement device and non-customized mandibular advancement device, both of which have their own advantages and characteristics. Customized mandibular advancement device is tailored to the patient's oral model to perfectly fit the patient's oral structure, so it has better comfort. But the customization of mandibular advancement device usually needs the full participation of the dentist in the customization of mandibular advancement device, and the customization will result in higher cost. Therefore, for some patients with limited budget who need to use it immediately, non-customized mandibular advancement device is a better choice.

[0005] The choice of customized and non-customized mandibular advancement device needs to consider the budget, the severity of the patient's OSA, the urgency of treatment, and the patient's preference for treatment, to determine which customized and non-customized mandibular advancement device is the most suitable treatment device for the patient. SUMMARY

[0006] The utility model discloses based on above insufficient, provide a convenient patient uses, improve the mandibular advancement device of patient's use comfort.

[0007] A mandibular advancement device with a robust structure, characterized by comprising:

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

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

[0010] The upper tray assembly comprises an upper shapeable component and an upper support, the upper shapeable component and the upper support are heated to different temperatures for shape change;

[0011] The lower tray assembly comprises a lower shapeable component and a lower support, the lower shapeable component and the lower support are heated to different temperatures for shape change;

[0012] The upper support and the lower support have a front side edge close to the labial side and a rear side edge close to the lingual side, at least the upper support has a protruding front wall at the front side edge, and at least the lower support has a protruding rear wall at the rear side edge;

[0013] The rear wall of at least the lower support comprises at least a baffle portion at the median sagittal plane;

[0014] At least part of the front wall of at least the upper support is inclined towards the lingual side.

[0015] In one of the embodiments, the upper shapeable component and the lower shapeable component are configured to be softened after being heated in hot water, so as to be adjusted and shaped to match the shape of the patient's maxillary dentition and mandibular dentition respectively when the patient bites.

[0016] In one of the embodiments, the upper shapeable component and the lower shapeable component comprise a flexible thermoplastic material.

[0017] In one of the embodiments, the hardness of the material of the upper support and the lower support is at least partially greater than the hardness of the material of the upper shapeable component and the lower shapeable component.

[0018] In one of the embodiments, the upper support and the lower support each have a bottom wall opposite to the occlusal surface of the teeth when biting, and the bottom wall of the upper support and the bottom wall of the lower support at least partially contact when positioned in the patient's oral cavity.

[0019] In one of the embodiments, the length of the baffle portion at the position of the rear side edge is greater than 10% of the full length of the rear side edge of the lower support.

[0020] A mandibular advancement device having a robust structure, comprising:

[0021] An upper tray assembly having an arcuate outer shape to conform to the patient's upper dental arch;

[0022] A lower tray assembly having an arcuate outer shape to conform to the patient's lower dental arch;

[0023] The upper tray assembly includes an upper formable component and an upper support, the upper formable component and the upper support being heated to different temperatures at which they deform;

[0024] The lower tray assembly includes a lower formable component and a lower support, the lower formable component and the lower support being heated to different temperatures at which they deform;

[0025] The upper and lower supports have a labial-side proximal side and a lingual-side distal side, the upper and lower supports having a protruding anterior wall at the proximal side and a protruding posterior wall at the distal side;

[0026] The at least upper support's anterior and posterior walls include a clamping portion positioned to be adjacent to the patient's molar region when positioned in the patient's mouth;

[0027] The at least lower support's posterior wall further includes a baffle portion at the median sagittal plane.

[0028] In one embodiment, the arcuate shape of the upper and lower tray assemblies is at least one of an oval arc, a tapered arc, and a square arc.

[0029] In one embodiment, the baffle portion is divided into a plurality of spaced apart portions.

[0030] In one embodiment, the at least lower formable component has a shape that engages and matches the baffle portion.

[0031] In one embodiment, the upper and lower formable components are made of a formable material that deforms at a temperature less than 100 degrees Celsius.

[0032] In one embodiment, the upper and lower supports are made of a material that has a high temperature stability that deforms at a temperature greater than 100 degrees Celsius.

[0033] A mandibular advancement device having a robust structure, comprising:

[0034] An upper tray assembly configured to be positioned adjacent to the patient's upper dental arch when positioned in the patient's mouth;

[0035] a lower tray assembly configured to be positioned adjacent to the lower dentition of the patient when positioned in the oral cavity of the patient;

[0036] the upper tray assembly comprises an upper formable component and an upper support, the upper formable component and the upper support being heated to different temperatures at which they deform;

[0037] the lower tray assembly comprises a lower formable component and a lower support, the lower formable component and the lower support being heated to different temperatures at which they deform;

[0038] the upper and lower supports have a front side proximate the labial side and a back side proximate the lingual side, the upper and lower supports having a protruding front wall at the front side and a protruding back wall at the back side;

[0039] wherein the front and back walls of the at least upper support comprise a clamping portion positioned proximate the molar position when positioned in the oral cavity of the patient;

[0040] wherein at least one of the distance between the front and back walls of the clamping portion is greater than the distance between the front and back walls of the upper and lower supports elsewhere, and the ratio of the two distances is at least 1.12:1;

[0041] wherein at least a portion of the front wall of the at least upper support is inclined towards the lingual side.

[0042] In one embodiment, the upper and lower supports are configured to engage and support the upper and lower formable components, respectively.

[0043] In one embodiment, the upper and lower supports have a connecting module therebetween.

[0044] In one embodiment, the upper and lower supports each have a bottom wall opposite the occlusal surface of the teeth when occluded, and the connecting module comprises a detent adjustment catch disposed on the bottom wall.

[0045] In one embodiment, the connecting module comprises a protrusion disposed on the front and / or back wall of the upper and / or lower support.

[0046] A mandibular advancement device having a robust structure, comprising:

[0047] an upper tray assembly having an arcuate outer shape to conform to the curvature of the upper dentition of the patient;

[0048] a lower tray assembly having an arcuate outer shape to conform to the curvature of the lower dentition of the patient;

[0049] the upper tray assembly comprises an upper formable component and an upper support, the upper formable component and the upper support being heated to different temperatures at which they deform;

[0050] The lower tray assembly comprises a lower moldable component and a lower support, the lower moldable component and the lower support are heated to different temperatures for deformation;

[0051] The upper support and the lower support have a front side edge close to the labial side and a rear side edge close to the lingual side, the at least upper support has a protruding front wall at the front side edge, and the at least lower support has a protruding rear wall at the rear side edge;

[0052] The rear wall of the at least lower support at least comprises a baffle portion at the median sagittal plane;

[0053] The front wall of the at least upper support has an outer wall towards the labial side and an inner wall opposite to the outer wall, and the angle between the inner wall of the front wall of the upper support at the median sagittal plane and the horizontal plane is less than 90°;

[0054] The height of the front wall of the at least upper support is less than 19.5mm.

[0055] In one embodiment, the upper tray assembly and the lower tray assembly are in the form of middle high and both sides low.

[0056] In one embodiment, in the lower tray assembly, the maximum height of the baffle portion is less than or equal to the maximum height of the lower moldable component.

[0057] In one embodiment, the upper tray assembly and the lower tray assembly are made of at least two different materials.

[0058] In one embodiment, the upper moldable component and the lower moldable component have a projection area on the horizontal plane greater than the projection area of the upper support and the lower support on the horizontal plane.

[0059] The mandibular advancement device of the utility model has at least the following beneficial effects:

[0060] 1) Through complex investigation, design, experiment and other processes, the utility model discloses a brand-new mandibular advancement device, which is designed to meet the oral structure of human body and further improve its use effect and stability. First, it is understood that the existing mandibular advancement device on the market has some problems that need to be improved, including the non-customized mandibular advancement device generally has the problem of easy falling off when opening the mouth. Through collecting feedback on the existing non-customized mandibular advancement device on various e-commerce platforms, it is found that the feedback is generally poor. After detailed patient demand investigation and a large amount of data analysis on the oral cavity, combined with the oral structure and use habits of different patient groups, several key factors of the problem are found out. a. The upper tray assembly is prone to fall downward automatically under the action of gravity; b. The outer surface of the patient's incisal tooth is not fitted with the shapeable part; c. The upper tray assembly and the lower tray assembly are not easy to fit with the patient's molar at the molar position, and there is a risk of falling off; d. During the patient's occlusion, the lower shapeable part is easy to be separated from the lower support due to the force generated by the patient's mandible returning to the original position, so that the mandibular advancement device fails. Based on the above problems, the causes of the problems are analyzed one by one and the methods to solve the problems are found out, and then repeated tests are carried out, so that a more effective mandibular advancement device based on theory and practice is obtained. ① Since the occlusion of the maxillary dentition and the mandibular dentition is actually the rotation and movement of the mandibular condyle in the glenoid fossa with the condylar process as the node, it is the movement of the mandibular dentition towards the maxillary dentition. Therefore, the shaping process of the upper shapeable part is actually that the mandibular dentition pushes the upper tray assembly and the lower tray assembly upward until the upper shapeable part is extruded with the maxillary dentition. During this process, the outer surface of the incisal tooth is an inclined surface rather than a vertical plane, and the extruded surface of the upper shapeable part during the vertical upward movement is a vertical inner surface. The gap formed by the angle difference makes the upper shapeable part unable to fit the maxillary dentition, so that the upper tray assembly falls off. Therefore, a front wall with an inwardly inclined tendency is designed, which pushes the overflow material towards the outer surface of the incisal tooth during the upward extrusion of the upper tray assembly on the maxillary dentition, so that the upper shapeable part and the maxillary dentition can be perfectly fitted during the shaping process. The inwardly inclined front wall also cooperates with the rear wall to clamp the incisal tooth, and the cooperation of the front wall with the inclined angle and the rear wall makes the clamping of the incisal tooth more stable, ensuring the stability of the mandibular advancement device. ② The molar itself is relatively short, and the fitting surface of the upper shapeable part and the lower shapeable part is not enough. Due to the gravity of the upper tray assembly, the mandibular advancement device at the molar position is often prone to falling off. Therefore, in order to more stably position the upper tray assembly and the lower tray assembly in the patient's oral cavity, at least the front wall and the rear wall of the upper support are arranged at the position of the patient's molar contact when the upper support is positioned in the patient's oral cavity. According to its function, it is divided into a clamping part, which is used to extrude the overflow material upward when the patient occludes and shapes the upper shapeable part and the lower shapeable part, so as to increase the contact area of the upper shapeable part and the lower shapeable part with the maxillary dentition and the mandibular dentition, and a clamping molar to make the connection of the upper tray assembly and the lower tray assembly more stable.③The working principle of the mandibular advancement device is to control the relative position of the maxillary dentition and the mandibular dentition to correct the patient by fixing the relative position of the upper tray assembly and the lower tray assembly. Although the mandibular dentition is controlled to move forward by the lower tray assembly, the mandibular dentition will still form a backward force on the lower tray assembly during wearing because it violates the original habit of the human body. This force generally acts on the lower moldable part. However, when there is no stable connection between the lower moldable part and the lower support, the lower moldable part is prone to displacement from the lower support, resulting in device failure. Therefore, at least the lower support is added with a posterior wall at the mid-sagittal plane, which is divided into a baffle part according to its function. Its role is to increase the resistance at the position where the lower moldable part falls off and to offset the force that causes it to fall off, so as to keep the relative position of the lower moldable part and the lower support unchanged. ④After the above structure, in order to overcome the influence of the weight of the upper tray assembly and improve the comfort of wearing, repeated experimental tests are conducted on the above structure, and multiple iterations are optimized, so that the above structure can play its maximum role while the patient is comfortable.

[0061] 2) Dentistry is a precise and data-based discipline, and any small difference in data (angle, weight, height, width, and softness of material, etc.) will affect the comfort and use effect of the patient. The utility model makes fine adjustment and repeated testing on these data to achieve the optimal use effect and better comfort. Through fine adjustment and data analysis and limitation of the designed structure, a more comfortable mandibular advancement device is obtained, and the treatment compliance of the patient is improved. ① The upper support and the lower support are wider at the position of the clamping part than at other positions. This improvement is based on the fact that the molars are usually wider than other parts in the oral structure, and the existing mandibular advancement device does not have a corresponding widened clamping part. The widened clamping part can make the upper and lower shapeable parts fit the patient's maxillary dentition and mandibular dentition more closely after occlusal shaping, and the clamping of the molars is not too tight, which meets the human comfort. ② The angle of the baffle part of at least the lower support is designed in accordance with the human body structure. Since the gum and lower teeth are not vertical planes, but have a slope shape, the angled baffle part matches the slope of the gum and teeth, so that the mandibular advancement device of the utility model can fit the patient's oral cavity more closely during use, making the patient feel more comfortable. The improvement of comfort is very important for the patient. If the device is not comfortable enough or affects the treatment during use, such as part falling off, the patient will not want to wear it for a long time, which will affect the treatment. Therefore, the present technology improves the patient's compliance to a certain extent, and can make the patient's treatment more stable. ③ In addition, the present technology also makes the mandibular advancement device play a more effective role in the patient's use process by reasonably specifying various parameters. For example, the height of the front wall is limited to make the front wall not scratch the patient's gum under the premise of clamping and tightly fitting the maxillary dentition and / or mandibular dentition; the inclination angle of the front wall is limited to ensure that at least the front wall of the upper support leans the at least upper shapeable part to the tongue side during occlusion, without tightly clamping the patient's maxillary dentition to cause the patient's discomfort; the length of the baffle part is limited to achieve effective support and fixation.

[0062] 3) The setting of the baffle part improves the service life of the mandibular advancement device, which is economical for the patient. The mandibular advancement device without the baffle part is prone to cause the lower plastic part to fall off, and because the upper plastic part and the lower plastic part are flexible materials, the upper plastic part and the lower plastic part are easily damaged. This increases the burden and cost of the patient to frequently replace the upper plastic part and the lower plastic part. The damage of the product not only reduces the service life of the mandibular advancement device, but also causes the instability of the mandibular advancement device, thereby weakening the treatment effect. The mandibular advancement device of the utility model sets the baffle part, which can effectively prevent the pulling of the two opposite forces on the lower plastic part by strengthening the fixation of the lower plastic part and the lower support, and ensure that the lower plastic part will not easily fall off or be damaged during use. This improvement significantly improves the stability and service life of the device, while ensuring the stability and reliability of the treatment effect.

[0063] 4) Generally speaking, although the customized mandibular advancement device has higher fit with teeth, can breathe with mouth open, etc., the customized mandibular advancement device needs to be customized and processed by means of oral scanning and other technologies, and a large amount of labor and time cost is needed, and generally a set of customized mandibular advancement device needs to cost thousands of dollars for the patient. The mandibular advancement device of the utility model has the following advantages compared with the customized mandibular advancement device, a. The product of the utility model can better achieve the effect of mouth breathing of the customized mandibular advancement device and is not easy to fall off. By combining the structures of the inclined front wall, the baffle part and the clamping part and limiting the parameters of each structure, the treatment effect of the patient is improved, and the treatment stability of the patient is ensured. b. The mandibular advancement device of the utility model has lower cost than the customized mandibular advancement device, reduces the economic pressure of the patient, and enables the patients with limited budget to use higher quality mandibular advancement devices. Customization often needs precise instruments and labor, and the patient needs to pay a higher cost. The design and output of the product of the utility model enable the patient to obtain a customized mandibular advancement device at a lower cost, which is a more economical and practical choice for some patient groups. c. The mandibular advancement device of the utility model can be quickly made and used, saving the waiting time of the patient for purchasing the customized mandibular advancement device, and being a better choice for some patients who hope to be treated quickly. d. The mandibular advancement devices on the market are usually customized to have the use effect of opening the mouth. However, the non-customized mandibular advancement device of the utility model can achieve the same effect, adapt to more patient needs, for example, for patients who are used to sleeping with their mouths open or patients who are prone to snoring in sleep, the mandibular advancement device that can open the mouth shows its unique advantages. It not only provides higher comfort, but also attracts a wider consumer group. e. The main part (i.e. the part directly contacting the teeth) of the customized mandibular advancement device is usually composed of an integral rigid material. The difference is that the mandibular advancement device of the utility model has a flexible material in contact with the inside of the patient's mouth, which does not resist the patient's oral internal tissues, reduces the foreign body sensation in the patient's mouth when wearing the product of the utility model, and at the same time, the flexible material acts as a buffer in the event of accidental collision, protecting the teeth and being a more secure mandibular advancement device. BRIEF DESCRIPTION OF DRAWINGS

[0064] Figure 1 is an overview of the human respiratory system, including the nasal cavity and oral cavity, larynx, esophagus, trachea, bronchus;

[0065] Figure 2 is an overview of the human oropharyngeal anatomy, which has several features of surface anatomy identified, including the oral cavity, pharynx, cervical spine, oral glands, mandible;

[0066] Figure 3is a view of the interior of the human mouth with several features of the surface anatomy identified, including teeth, palate, pharynx, tongue, gums;

[0067] Figure 4 is a lateral view of the human skull, including the mandible, teeth, vertebrae, larynx, maxilla, condyle;

[0068] Figure 5 is a lateral view of the human skull and oral musculature, including the buccinator, orbicularis oris, lip, commissure axis;

[0069] Figure 6 is a lateral view of the human head and mandibular structures, showing the approximate location of the maxillary dentition and the mandible;

[0070] Figure 7 is a detailed view of the structure of the mandible, including the teeth, chin, mandibular neck, condyle process, mandibular head;

[0071] Figure 8 is an anatomical overview of the mandible, including the teeth, mandibular body, mental spine, mandibular torus;

[0072] Figure 9 is a schematic view of the movement of the mandible relative to the maxilla, showing the rotation and movement of the mandible about the condyle process;

[0073] Figure 10 is a schematic view of the overall mandibular advancement device in embodiment one of the present application;

[0074] Figure 11 is an exploded view of the structure of the mandibular advancement device in embodiment one of the present application;

[0075] Figure 12 is a top view of the upper tray assembly and the shape of the maxillary dentition in multiple embodiments of the present application;

[0076] Figure 13 is a schematic view of the horizontal plane, sagittal plane, and coronal plane in multiple embodiments of the present application;

[0077] Figure 14 is a schematic view of the front side and the back side of the mandibular advancement device in multiple embodiments of the present application;

[0078] Figure 15 is a schematic view of the front wall of the mandibular advancement device in embodiment one of the present application, designed with a certain inclination angle;

[0079] Figure 16 is a schematic view of the back wall of the mandibular advancement device in embodiment one of the present application, designed with a certain inclination angle;

[0080] Figure 17The schematic view of the lower plastic part and the lower support in the mandibular advancement device in multiple embodiments of the utility model is separated;

[0081] Figure 18 The schematic view of the upper dentition and the upper plastic part shaping process in the prior art mandibular advancement device;

[0082] Figure 19 The schematic view of the upper dentition and the upper plastic part shaping process in multiple embodiments of the utility model is shown in the figure;

[0083] Figure 20 The top view of the mandibular advancement device in multiple embodiments of the utility model is shown in the figure;

[0084] Figure 21 The top view of the upper plastic part and the upper support in multiple embodiments of the utility model is shown in the figure;

[0085] Figure 22 The schematic view of the baffle part in embodiment one of the utility model has multiple forms;

[0086] Figure 23 The schematic view of the upper support and the lower support in embodiment one of the utility model is shown in the figure;

[0087] Figure 24 The closed state schematic view of the mandibular advancement device with the connecting module being a protrusion in multiple embodiments of the utility model is shown in the figure;

[0088] Figure 25 The open state schematic view of the mandibular advancement device with the connecting module being a protrusion in multiple embodiments of the utility model is shown in the figure;

[0089] Figure 26 The schematic view of the upper support or the lower support with the clamping part in multiple embodiments of the utility model is shown in the figure;

[0090] Figure 27 The schematic view of the height of the front wall at the median sagittal plane and the length of the clamping part in multiple embodiments of the utility model is shown in the figure;

[0091] Figure 28 The schematic view of the distance between the front wall and the rear wall at the median sagittal plane and the clamping part in multiple embodiments of the utility model is shown in the figure;

[0092] Figure 29 The top view of the upper support or the lower support in multiple embodiments of the utility model is shown in the figure;

[0093] Figure 30 The schematic view of the height difference and the width difference of the clamping part at the A-A and B-B position cross sections of the upper support or the lower support in multiple embodiments of the utility model is shown in the figure; Figure 29 ​

[0094] Figure 31 The clamping part of another embodiment of the embodiment one of the utility model has different forms of schematic diagram;

[0095] Figure 32 The baffle part and the clamping part of the embodiment two of the utility model are two parts of the schematic diagram of being spaced apart;

[0096] Figure 33 The baffle part of the embodiment two of the utility model is composed of the schematic diagram of a plurality of spaced apart walls;

[0097] Figure 34 The connecting module of the embodiment one of the utility model is the schematic diagram of a buckle;

[0098] Figure 35 The connecting module of the embodiment one of the utility model is the connecting schematic diagram of a buckle. DETAILED DESCRIPTION

[0099] In order to make the above-mentioned purpose, features and advantages of the utility model more obvious and easy to understand, the specific embodiments of the utility model are described in detail below in conjunction with the drawings. In the following description, a lot of specific details are set forth in order to fully understand the utility model. However, the 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 utility model, so the utility model is not limited by the specific embodiments disclosed below.

[0100] Compared with the mandibular advancement device on the market, the front wall and the rear wall in the upper support and the lower support are carefully designed and adjusted, the front wall of at least the upper support is inclined inward, and the rear wall of at least the lower support is increased at the median sagittal plane, so that the mandibular advancement device of the utility model is more stable. In addition, a molar clamping part is also added, and at least one protrusion is added to the upper support and / or the lower support. The design of the above-mentioned multiple structures maximizes the stability of the mandibular advancement device, thereby improving the effectiveness and use comfort of the mandibular advancement device. The situation of the mandibular advancement device falling during the sleep of the patient is prevented, the compliance of the patient is increased in this respect, and the effectiveness, comfort, reliability and service life are all reached in a more optimal state. Therefore, the mandibular advancement device of the utility model not only improves the performance index, but also brings a more stable, safe and comfortable use experience to the patient.

[0101] The utility model provides a kind of mandibular advancement device 1 of facilitating patient use, improve the use comfort of patient.

[0102] Specifically, please combine Figures 10 to 21The mandibular advancement device 1 comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 has an arcuate outer shape to conform to the curvature of the patient's upper dentition and is configured to be positioned adjacent to the patient's upper dentition when positioned in the patient's oral cavity. The lower tray assembly 3 has an arcuate outer shape to conform to the curvature of the patient's lower dentition and is configured to be positioned adjacent to the patient's lower dentition when positioned in the patient's oral cavity. The upper tray assembly 2 and the lower tray assembly 3 are each configured to at least partially conform to the patient's upper dentition and lower dentition, respectively, during wear, and the curvature of the patient's dentition can generally be classified as one of an oval arcuate shape, a tapered arcuate shape, a square arcuate shape, and the like. Accordingly, the arcuate shape of the upper tray assembly 2 and the lower tray assembly 3 can be at least one of an oval arcuate shape, a tapered arcuate shape, a square arcuate shape, and the like (e.g. Figure 12

[0103] Further, the upper tray assembly 2 comprises an upper moldable component 21 and an upper support 22, and the lower tray assembly 3 comprises a lower moldable component 31 and a lower support 32. The upper moldable component 21 and the lower moldable component 31 are configured to at least partially contact the patient's upper dentition and lower dentition, respectively, when the mandibular advancement device 1 is positioned in the patient's oral cavity. The upper moldable component 21 and the lower moldable component 31 have a tooth-occlusal surface that can be a surface having at least one groove to accommodate overflow material when the patient bites, to better conform to the patient's upper dentition and lower dentition. In some cases, the tooth-occlusal surface of the upper moldable component 21 and / or the lower moldable component is a flat or curved surface without grooves.

[0104] The upper support 22 and the lower support 32 are each configured to engage and support the upper moldable component 21 and the lower moldable component 31, respectively. The upper support 22 and the lower support 32 each have a bottom wall 6 that opposes the tooth-occlusal surface when occluded, and the bottom wall 6 of the upper support 22 and the bottom wall 6 of the lower support 32 are configured to at least partially contact each other when positioned in the patient's oral cavity. The upper support 22 and the lower support 32 each have a labial side 4 proximate to the labial side and a lingual side 5 proximate to the lingual side (e.g. Figure 14 ​As shown, during treatment, the mandibular advancement device 1 pulls the patient's mandible forward relative to the maxilla, improving the relative position of the maxilla and mandible. Therefore, due to habit, the patient's mandible will involuntarily pull back to its original position during treatment, while the pulling force of the maxilla is opposite to that of the mandible. Therefore, at least the upper support 22 has a protruding anterior wall 41 on its anterior side 4, and at least the lower support 32 has a protruding posterior wall 51 on its posterior side 5. The anterior wall 41 is configured to prevent the upper malleable component 21 and / or the lower malleable component from being pulled forward and thus separating from the upper support 22 and / or the lower support 32, and the posterior wall 51 is configured to prevent the upper malleable component 21 and / or the lower malleable component from being pulled backward and thus separating from the upper support 22 and / or the lower support 32. In some cases, the front wall 41 and / or rear wall 51 of the upper support 22 and / or lower support 32 may form a groove to accommodate the upper malleable component 21 and / or lower malleable component 31, thereby forming a more stable connection between the upper support 22 and / or lower support 32 and the upper malleable component 21 and / or lower malleable component 31.

[0105] The main use of the mandibular advancement device 1 is to engage the upper moldable part 21 with the upper holder 22 to form the upper tray assembly 2, engage the lower moldable part 31 with the lower holder 32 to form the lower tray assembly 3, and to pull the patient's lower jaw away from the tongue side to open the patient's airway by the fixed relative position between the upper tray assembly 2 and the lower tray assembly 3. Generally, the upper tray assembly 2 and the lower tray assembly 3 are composed of two separate parts, and the connection between the upper tray assembly 2 and the lower tray assembly 3 is generally composed of the upper holder 22 and the lower holder 32. Specifically, in order to prevent the upper tray assembly 2 and the lower tray assembly 3 from separating the constituent parts during use by the patient to ensure the effectiveness of the treatment, the upper holder 22 and the lower holder 32 have a connection module 7 between them, and the connection module 7 in the upper holder 22 and the lower holder 32 ensures the function of the mandibular advancement device 1, that is, to move the lower tray assembly 3 relative to the upper tray assembly 2 to the front of the lip side to accommodate and fix the patient's lower jaw in the correct and appropriate position. In some special cases, the upper tray assembly 2 and the lower tray assembly 3 can also be connected by a hinge or any other means to become an integral whole that cannot be disassembled. And in the upper tray assembly 2 and the lower tray assembly 3, the upper moldable part 21 and the lower moldable part 31 can be detachably engaged with the upper holder 22 and the lower holder 32, or fixed and not detachable. The form of detachable engagement here includes protrusions, slot form buckles 72 and / or additional components such as latches, screws, pins, magnets, etc. In order to achieve better fixation effect and the convenience of the mandibular advancement device 1, the connection of the upper moldable part 21 and the lower moldable part 31 with the upper holder 22 and the lower holder 32 is preferably the buckle 72 connection, and the buckle 72 connection described here is generally that the upper moldable part 21 and the lower moldable part 31 have protrusions that match the slots on the upper holder 22 and the lower holder 32, respectively, or the upper holder 22 and the lower holder 32 have protrusions that match the slots of the upper moldable part 21 and the lower moldable part 31, respectively. And the protrusions and slots can be symmetrically distributed at the middle position (i.e. the position of the mandibular advancement device 1 close to the patient's front teeth) and / or the two ends (i.e. the end of the mandibular advancement device 1 close to the patient's temporomandibular joint).

[0106] The material selection of the upper tray assembly 2 and the lower tray assembly 3 is wide-ranging. Since the upper moldable part 21 and the lower moldable part 31 are the parts that mainly contact the patient's teeth and part of the gums during wearing, the upper bracket 22 and the lower bracket 32 play a role of supporting, fixing 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 material of the upper bracket 22 and the lower bracket 32 is at least partially greater than the hardness of the material of the upper moldable part 21 and the lower moldable part 31, wherein the hardness of the material 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 are also made of a single material to obtain different material rigidities by special manufacturing methods. When selecting the materials constituting the mandibular advancement device 1, the biocompatibility, durability, functional stability, patient comfort and ease of cleaning and other aspects are widely considered, and plastic or polymer materials suitable for oral medical devices and can be molded are selected. 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.

[0107] The upper moldable part 21 and the upper support 22 are heated to different temperatures for shape deformation, and the lower moldable part 31 and the lower support 32 are heated to different temperatures for shape deformation. The upper moldable part 21 and the lower moldable part 31 are made of a material that can be molded, and the temperature required for heating to shape deformation is less than 100 degrees Celsius. The upper support 22 and the lower support 32 are made of a material that has high temperature stability, and the temperature required for heating to shape deformation is greater than 100 degrees Celsius. Specifically, the upper moldable part 21 and the lower moldable part 31 comprise a flexible thermoplastic material, and the upper moldable part 21 and the lower moldable part 31 are configured to soften after being heated in hot water, so as to adjust and mold to match the shape of the patient's upper and lower dentition when the patient bites. (In this context, hot water refers to water heated to at least 60 degrees Celsius) During wearing, the patient only needs to heat the upper tray assembly 2 and the lower tray assembly 3 in hot water, and after cooling, 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 upper moldable part 21 and the lower moldable part 31 by biting to achieve a fit with the dentition. The flexible thermoplastic material has a certain flexibility and can withstand repeated mechanical stress without failure, which is very important for the patient to use the moldable part of the mandibular advancement device 1 when using it. In addition, the flexible thermoplastic material also has the advantages of light weight and environmental protection.

[0108] The upper support 22 and the lower support 32 need to be made of a more stable material than the upper moldable part 21 and the lower moldable part 31, and need to have high temperature stability to maintain their original shape after molding, providing structural support for the mandibular advancement device 1. In general, the upper support 22 and the lower support 32 need to withstand long-term use without changing their shape, so they are made of a more durable material than the upper moldable part 21 and the lower moldable part 31. If the upper support 22 and the lower support 32 also use thermoplastic material, the deformation temperature will be higher than that of the upper moldable part 21 and the lower moldable part 31, which can ensure that the upper support 22 and the lower support 32 are not affected during the molding of the upper moldable part 21 and the lower moldable part 31.

[0109] In the present technology, the size of the upper moldable part 21 and the lower moldable part 31 and the upper support 22 and the lower support 32 is also limited. The projected area of the upper moldable part 21 and the lower moldable part 31 in the horizontal plane is greater than the projected area of the upper support 22 and the lower support 32 in the horizontal plane (for example Figure 21The upper and lower moldable parts 21, 31 are made of a more flexible material than the upper and lower supports 22, 32, which can reduce irritation and scratching of the soft tissue in the mouth, and the weight of the flexible material used in the upper and lower moldable parts 21, 31 is greater than or equal to 3.3g. In addition, considering the difference in the distance from the inner lip to the posterior molar region of different patients, an excessively long device can cause scratching of the posterior molar tissue in the mouth, especially in the area where the joint is located, which can affect the occlusal function. For people whose upper and lower moldable parts 21, 31 are not suitable in size, the length can be trimmed according to individual needs and preferences, improving the comfort and personalized adaptability of use. This design not only ensures the functionality of the mandibular advancement device 1, but also gives patients more autonomy to adjust. Furthermore, according to this principle, since the height of the upper and lower dental arches in the mouth is in the form of high in the middle and low on both sides, the upper and lower tray assemblies 2, 3 are also designed in the form of high in the middle and low on both sides to prevent irritation and scratching of the soft tissue in the mouth.

[0110] The following describes several structures of the mandibular advancement device 1 of the present application in conjunction with specific examples.

[0111] Example 1

[0112] The mandibular advancement device 1 of the present example comprises: an upper tray assembly 2 configured to be positioned adjacent to the upper dental arch of a patient when positioned in the mouth of the patient; and a lower tray assembly 3 configured to be positioned adjacent to the lower dental arch of a patient when positioned in the mouth of the patient. The upper tray assembly 2 comprises an upper moldable part 21 and an upper support 22, and the upper moldable part 21 and the upper support 22 are heated to different temperatures for deformation; the lower tray assembly 3 comprises a lower moldable part 31 and a lower support 32, and the lower moldable part and the lower support 32 are heated to different temperatures for deformation.

[0113] The upper support 22 and the lower support 32 have a front side edge 4 near the labial side and a rear side edge 5 near the lingual side, and the at least upper support 22 has a protruding front wall 41 on the front side edge 4, and the at least lower support 32 has a protruding rear wall 51 on the rear side edge 5.

[0114] The rear wall 51 of the at least lower support 32 at least comprises a baffle portion 511 at the median sagittal plane. At least part of the front wall 41 of the at least upper support 22 is inclined towards the lingual side (as shown in Figure 15

[0115] ​The front wall 41 and the rear wall 51 of the at least upper bracket 22 comprise a clamping portion 512 positioned close to the molar position when the patient's oral cavity is positioned. The rear wall 51 of the at least lower bracket 32 comprises at least a baffle portion 511 at the median sagittal plane.

[0116] The opening and closing of the mouth mainly relies on the rotation and sliding of the mandible at the mandibular joint. When the condylar process of the mandible rotates in the glenoid fossa, the mandible moves upward and forward, thereby closing the mouth. Therefore, when the patient bites the mandibular advancement device 1 for occlusal molding, the lower tray assembly 3 is pushed upward by the mandible to top the upper molar row, thereby completing the molding. However, the outer surface of the central incisor of the upper molar row is often at an angle to the vertical plane, and thus, in the process of extruding the upper moldable component 21 to the upper molar row by the upper tray assembly 2, a gap is left between the vertical inner surface formed after the molding of the upper moldable component 21 and the inwardly inclined outer surface of the central incisor, which cannot be fitted (as shown in Figure 18 Therefore, the at least upper bracket 22 of the mandibular advancement device 1 is improved. The front wall 41 of the at least upper bracket 22 is designed to be inclined at least partially toward the lingual side. This improvement makes the at least upper moldable component 21 and the at least upper molar row in the process of occlusion, and the inclined front wall 41 extrudes the material overflowing from the at least upper moldable component 21 to the lingual side, fills or reduces the gap that should be formed originally, and enhances the stability of the mandibular advancement device 1 (as shown in Figure 19 The inclination angle of the front wall 41 determines the stability and comfort of the at least upper tray assembly 2 and the at least upper molar row. If the inclination angle is too large, the patient's gums are easily scratched or the patient feels uncomfortable. If the inclination angle is too small, the functionality of the structure is easily reduced. Therefore, the front wall 41 of the at least upper bracket 22 is provided with an outer wall toward the labial side and an inner wall opposite to the outer wall, and the angle between the inner wall of the front wall 41 of the at least upper bracket 22 and the horizontal plane at the median sagittal plane is less than 90° (as shown in Figure 15 and ∠α≤90°). Through the research on various data such as the length and width of the oral cavity of different populations, it is concluded that the height of the front wall 41 of the at least upper bracket 22 is less than 19.5 mm (as shown in Figure 27 and d1≤19.5 mm).

[0117] The main function of the mandibular advancement device 1 is to pull the patient's lower jaw forward (away from the lingual direction), while due to habit, the patient's lower jaw will generate a force to shrink backward (towards the lingual direction) on the lower shaping member 31. Since the lower shaping member 31 is made of flexible material, at this time it is extremely easy to cause excessive deformation of the lower shaping member 3131 or the occurrence of the front-back misalignment or separation of the lower support 3232 and the lower shaping member 3131 (such as Figure 17To prevent at least the lower moldable part 31 and at least the lower support 32 from slipping or falling off during wearing, a baffle portion 511 is provided on the rear wall 51 of at least the lower support 32 at the median sagittal plane. The provision of the baffle portion 511 helps to provide the at least lower moldable part 31 with a force against which it can deform to maintain its original shape, and to fix the at least lower moldable part 31 and at least the lower support 32 of the lower jaw advancement device 1, preventing them from falling off due to use habits during wearing. This directly affects the therapeutic effect of the lower jaw advancement device 1, and the lower jaw advancement device 1 with the baffle portion 511 can more effectively alleviate the symptoms of obstructive sleep apnea syndrome. In some cases, the at least lower moldable part 31 has a shape that engages and matches the baffle portion 511 to optimize the volume and comfort of use of the lower jaw advancement device 1. Specifically, the at least lower moldable part 3131 closely fits the shape of the baffle portion 511, so that the volume of the at least lower tray assembly 3 does not increase due to the addition of the baffle portion 511. This closely fitting design not only ensures the stability of the assembly when positioned in the patient's mouth, but also effectively reduces the occurrence of foreign body sensation in the mouth. The baffle portion 511 can be provided on only one of the upper support 22 and the lower support 32, and is preferably provided on the lower support 3232. Obviously, the baffle portion 511 can also be provided on both the upper support 22 and the lower support 32. To make the baffle portion 511 an effective functional part, the parameters of the baffle portion 511 are also limited in this embodiment. The length of the baffle portion 511 provided at the position of the rear side 5 is greater than 10% of the full length of the rear side 5 of the lower support 32, and the baffle portion 511 is preferably provided on the middle portion of the at least lower support 32. Since the overall shape of the upper support 22 and the lower support 32 is arched, if the two sides are too long, the two side portions are actually ineffective regions. In combination with various data such as the length and width of the oral cavities of different populations, the length of the baffle portion 511 is preferably greater than or equal to 5 mm. Due to the limitations of its material and size, the thickness of the baffle portion 511 is in the range of 0.3 mm to 10 mm to provide support to the moldable portion within an appropriate range. The baffle portion 511 is generally not provided beyond the end of the patient's gum, so in at least the lower tray assembly 3, the maximum height of the baffle portion 511 is less than or equal to the maximum height of the lower moldable part 31, and the height of the baffle portion 511 is less than or equal to 15 mm. The baffle portion 511 can have various forms, and can be in the form of a middle-high and two-side-low shape to conform to the oral cavity morphology of most populations, or can be in the form of a flat top end; the top and bottom edges of the baffle portion 511 can have continuous curvature or non-continuous curvature; the length of the baffle portion 511 can also be adjusted according to actual conditions, and can be in the form of a longer or shorter length (e.g. Figure 22(As shown). To better conform to the structure of the human oral cavity, the baffle portion 511 of the posterior wall 51 can be set as a wall with an inclined angle. The angle between the inner wall of the baffle portion 511 and the horizontal plane at the midsagittal plane is set to a range of 20°-150°, with 45°-90° being preferred (e.g., Figure 16 In the mean square, 20°≤∠β≤150°.

[0118] The connecting module 7 between the upper support 22 and the lower support 32 includes a protrusion 71 disposed on the front wall 41 and / or rear wall 51 of the upper support 22 and / or the lower support 32. This protrusion 71 allows the patient's mouth to open and close during treatment (e.g., ...). Figures 23-25 As shown), compared to the traditional connecting module 7, this increases the flexibility of the mandibular advancement device 1 and improves patient compliance. The mechanism of the protrusion 71 is that it has a certain height, and its anterior-posterior positional relationship restricts the anterior-posterior positional relationship between the upper tray assembly 2 and the lower tray assembly 3. Even when the upper tray assembly 2 and the lower tray assembly 3 are separated, as long as the protrusion 71 remains in contact and restricts them, the mutual restriction between the upper tray assembly 2 and the lower tray assembly 3 can still be achieved. This allows the mandibular advancement device to function even when the mouth can open and close (e.g., ...). Figure 24 The upper tray assembly 2 and the lower tray assembly 3 are in a closed configuration. Figure 25 The upper tray assembly 2 and the lower tray assembly 3 are in an open form (both forms still achieve the effect of mandibular advancement). The protrusion 71 is generally configured to connect to the front wall 41 of the upper support 22 and / or the lower support 32. In some special cases, the protrusion 71 can also be configured to connect to the rear wall 51 of the upper support 22 and / or the lower support 32. The protrusion 71 can have various forms; in one case, both the upper support 22 and the lower support 32 of the mandibular advancement device 1 have protrusions 71, or the protrusion can be provided on only one of the upper support 22 and the lower support 32.

[0119] The front wall 41 of the front side 4 and the rear wall 51 of the rear side 5 of the upper support 22 and the lower support 32 extend from the front side 4 and the rear side 5, respectively, including a clamping portion 512 (e.g., Figure 26The molars are usually larger and lower than other teeth in both the upper and lower dental arches, thus the molars are less likely to be engaged and clamped by the upper and lower plasticizing components 21 and 31 than other teeth, which can easily lead to the separation of the upper and lower tray assemblies 2 and 3 from the upper and lower dental arches, respectively, especially the upper tray assembly 2 which is easily separated from the upper dental arch with the assistance of its own gravity. Through data analysis of the molars, after multiple attempts at design and testing, it is concluded that adding a clamping portion 512 to the two side walls of the upper and lower supports 22 and 32 at the positions where they contact the molars when positioned in the patient's mouth is a better approach for clamping the upper and lower plasticizing components 21 and 31. The clamping portion 512 of the front wall 41 and / or the rear wall 51 can block the softened material of the upper and / or lower plasticizing components 21 and 31 from dispersing to both sides when the patient bites. The upper and / or lower tray assemblies 2 and 3 with the clamping portion 512 can force the softened material to clamp the molar portion upwards when biting, increasing the contact area of the shaped upper and / or lower plasticizing components 21 and 31 with the molars. The design of the clamping portion 512 ensures a firm connection between the key areas of the upper and lower supports 22 and 32 and the molars. This improvement makes the upper and / or lower tray assemblies 2 and 3 better maintain their original positions when worn by the patient, reducing the likelihood of falling off, and increasing the stability and reliability of the mandibular advancement device 1. After designing the clamping portion 512, data is also defined for the clamping portion 512 to better achieve its function. By researching and collecting the lengths and widths of molars of different populations and even different races, data such as the length, width, and height of the clamping portion that is more suitable for a wide range of populations is obtained, as well as making it have the least impact on the patient under the premise of being able to function. The length of the clamping portion is greater than or equal to 20 mm (as shown in d2 of FIG. 12). Since the molars are originally larger and lower than the teeth at other positions, the distance between the clamping portion 512 corresponding to the front wall 41 and the rear wall 51 is greater than at other positions, and its height is lower than at other positions (as shown in FIG. 12, the clamping portion 512 has a height difference S1 and a width difference S2 from other positions). Therefore, the shortest distance between the front wall 41 and the rear wall 51 of the clamping portion 512 is defined to be greater than the shortest distance between the front wall 41 and the rear wall 51 at other positions of the upper and lower supports 22 and 32, and the ratio of the two distances is at least 1.12:1 (as shown in the ratio of d4 to d3 in FIG. 12). The wall of the clamping portion 512 can be at an angle with the bottom wall 6, or it can be perpendicular to the bottom wall 6. Figure 27 Figure 30 Figure 28

[0120] ​​​The connecting module 7 can also be in other forms than the protrusion, which is different from the protrusion form but has the same principle, specifically, the upper support 22 and the lower support 32 each have a bottom wall 6 opposite the occlusal surface of the teeth when occluded, and the connecting module 7 includes a gear adjustment buckle 72 (as shown in Figure 34 、 Figure 35 ) arranged on the bottom wall 6. In the mandibular advancement device 1 of this structure, the upper tray assembly 2 and the lower tray assembly 3 cannot be separated when positioned in the patient's mouth, i.e., the patient cannot open his mouth during wearing. The adjustment buckle 72 in the mandibular advancement device 1 of this embodiment can have multiple (two or more) gears for adjustment, and the patient can choose the appropriate adjustment gear according to his own wearing comfort. The gear adjustment buckle 72 can have various forms, and is generally arranged at the position close to the lingual side of the upper support 22 and the lower support 32, and in some special cases, the gear adjustment buckle 72 can also be arranged at other positions. The gear adjustment buckle 72 can be in the form that the upper support 22 has a protrusion to cooperate with the groove of the lower support 32, or in the form that the lower support 32 has a protrusion to cooperate with the groove of the upper support 22, and in other cases, the gear adjustment buckle 72 can also be in any other form except the protrusion, groove and buckle. The upper support 22 and the lower support 32 can have multiple fixed connections between them in addition to the gear adjustment buckle 72 to additionally fix the upper support 22 and the lower support 32; or only the gear adjustment buckle 72 can be responsible for fixing the upper support 22 and the lower support 32.

[0121] In other embodiments, the upper support 22 and / or the lower support 32 have different forms for accommodating the molars at the clamping portion 512 position to adapt to different groups of people with different molar forms, such as people with longer, wider or shorter molars (as shown in Figure 31 ).

[0122] In other embodiments, the connecting module 7 can also adopt various forms other than the protrusion 71 and the buckle 72, including but not limited to threaded connection, hook connection, piston connection, welding connection, plug-in connection, pin connection, adhesive connection, spring connection, mortise and tenon connection or elastic band connection, etc. The connection mode can adopt one form, or even two or more forms can be combined. The selection of the appropriate connection mode depends on the specific design requirements, material properties and use environment to ensure that the connection is firm, reliable, durable, and needs to be convenient for production and installation, and convenient for the patient to adjust the operation.

[0123] Embodiment 2

[0124] The mandibular advancement device 1 of the present embodiment comprises: an upper tray assembly 2 having an arcuate outer shape to conform to the patient's upper dental arch; a lower tray assembly 3 having an arcuate outer shape to conform to the patient's lower dental arch. The upper tray assembly 2 comprises an upper thermoformable component 21 and an upper support 22, the upper thermoformable component 21 and the upper support 22 being heated to different temperatures for deformation; the lower tray assembly 3 comprises a lower thermoformable component 31 and a lower support 32, the lower thermoformable component 31 and the lower support 32 being heated to different temperatures for deformation.

[0125] The upper support 22 and the lower support 32 have a front side edge 4 near the labial side and a rear side edge 5 near the lingual side, the at least upper support 22 having a protruding front wall 41 at the front side edge 4, the at least lower support 32 having a protruding rear wall 51 at the rear side edge 5.

[0126] The upper support 22 and the lower support 32 have a front wall 41 and a rear wall 51, wherein the front wall 41 and the rear wall 51 comprise a clamping portion 512 positioned near the molar position when the device is in the patient's mouth. The rear wall 51 of the at least lower support 32 comprises at least a stop portion 511 at the median sagittal plane.

[0127] The present embodiment differs from the embodiment 1 in that at least one of the front wall 41 of the upper support 22 or the lower support 32, or the rear wall 51 of the upper support 22 or the lower support 32 is in a discontinuous form, i.e. composed of multiple disconnected walls with gaps, while the function remains unchanged. The discontinuous form has two cases: one is that different portions with different functions in the front wall 41 and the rear wall 51 of the upper support 22 and / or the lower support 32 are separated, such as the stop portion 511 and the clamping portion 512 being two separate portions (disconnected form of non-integral wall) (as shown in Figure 32 ). The other is that the wall with the same function is itself in a disconnected form, such as the stop portion 511 being composed of multiple disconnected walls (as shown in Figure 33The intermittent wall reduces the material usage of the upper bracket 22 and / or the lower bracket 32 in the mandibular advancement device 1 to some extent, realizes the light weight of the mandibular advancement device 1, and improves the use comfort of the patient. On the other hand, the intermittent wall increases the flexibility of the front wall 41 and / or the rear wall 51 of the upper bracket 22 and / or the lower bracket 32 to some extent. The increase in flexibility enables the patient who is not completely suitable for the upper bracket 22 and / or the lower bracket 32 to adjust the flexibility when positioned in the oral cavity of the patient, so as to better adapt to the movement of the shape of the patient and reduce the compression feeling on the teeth. For example, if the angle of the front wall 41 and / or the rear wall 51 of the upper bracket 22 and / or the lower bracket 32 is not the optimal wearing comfort angle of the patient when leaving the factory, the intermittent front wall 41 and / or the rear wall 51 can better adjust according to the oral structure of the patient to realize personalized adaptation. The adjustability ensures that each patient can find the most suitable wearing angle and size for himself / herself, further improving the wearing comfort and treatment effect. In addition, since the front wall 41 and the rear wall 51 of the upper bracket 22 and the lower bracket 32 have multiple functional partitions, the walls of different functional partitions are separated and uninterrupted, which helps to realize the respective functions of different functional walls without affecting each other. The structure of the intermittent wall also has additional advantages, such as enhancing the air permeability of the device, which can reduce the stuffy feeling when wearing.

[0128] In addition, the technical features in each of the above embodiments can be combined as needed to obtain a mandibular advancement device 1 including all or part of the above technical features.

[0129] The mandibular advancement device 1 with a stable structure implemented by the present application has at least the following beneficial effects:

[0130] 1) Through complex investigation, design, experiment and other processes, the utility model discloses a brand-new mandibular advancement device 1, make it accord with ergonomics and further improve its use effect and stability. First, it is understood that the existing market mandibular advancement device 1 has some problems that need to be improved, including the non-customized mandibular advancement device 1 generally has the problem of easy falling off when opening the mouth. In the major e-commerce platforms, the feedback of the existing non-customized mandibular advancement device is generally poor, after detailed patient demand investigation and a large number of data analysis about oral cavity, then combined with the oral structure and use habit of different patient groups, find out several key factors of the problem. a. The upper tray assembly 2 is easy to fall down automatically under the action of gravity; b. The patient's incisal surface and the shapeable component do not fit; c. The upper tray assembly 2 and the lower tray assembly 3 are not easy to fit with the patient's molar at the molar position, and there is a risk of falling off; d. During the patient's occlusion process, the lower shapeable component 31 is easy to be separated from the lower support 32 due to the force generated by the patient's mandible returning to the original position, so that the mandibular advancement device 1 fails. Based on the above problems, the causes of the problems are analyzed one by one and the methods to solve the problems are found out, and then repeated tests are carried out, and a more effective mandibular advancement device 1 based on theory and practice is obtained. ① Because the occlusion of the maxillary dentition and the mandibular dentition is actually the rotation and movement of the mandibular bone with the condylar process as the node in the mandibular fossa, the movement of the mandibular dentition towards the maxillary dentition. Therefore, the shaping process of the upper shapeable component 21 is actually that the mandibular dentition pushes the upper tray assembly 2 and the lower tray assembly 3 upwards until the upper shapeable component 21 is extruded with the maxillary dentition. And in this process, because the outer surface of the incisal tooth is an inclined surface rather than a vertical plane, and the extruded surface of the upper shapeable component 21 in the vertical upward pushing process is a vertical inner surface, the gap formed by the angle difference makes the upper shapeable component 21 unable to fit the maxillary dentition, so that the upper tray assembly 2 falls off. Therefore, the front wall 41 with an inwardly inclined tendency is designed to push the overflowing material towards the outer surface of the incisal tooth during the extrusion of the upper tray assembly 2 towards the maxillary dentition, so that the upper shapeable component 21 and the maxillary dentition can perfectly fit during the shaping process. The inwardly inclined front wall 41 also cooperates with the rear wall 51 to clamp the incisal tooth, and the cooperation of the front wall 41 with an inclined angle and the rear wall 51 makes the clamping of the incisal tooth more stable, ensuring the stability of the mandibular advancement device 1. ② The molar itself is relatively short, and the fitting surface of the upper shapeable component 21 and the lower shapeable component 31 is not enough, and due to the gravity of the upper tray assembly 2, the mandibular advancement device 1 at the molar position is often easy to fall off. Therefore, in order to more stably position the upper tray assembly and the lower tray assembly 3 in the patient's oral cavity, the front wall 41 and the rear wall 51 are arranged at the molar position when at least the upper support 22 is positioned in the patient's oral cavity.According to its function, it is divided into a clamping part 512, which is used to press the overflowing material upwards when the patient bites the upper and lower plastic parts 21 and 31 to increase the contact area of the upper and lower plastic parts 21 and 31 with the upper and lower dental arches, and to clamp the molars to make the connection of the upper and lower tray assemblies 2 and 3 more stable. ③ The working principle of the lower jaw forward movement device 1 is to control the relative position of the upper and lower dental arches by fixing the relative position of the upper and lower tray assemblies 2 and 3. Although the forward movement of the lower dental arch is controlled by the lower tray assembly 3, the lower dental arch will still form a backward force on the lower tray assembly 3 during wearing because it goes against the original habit of the human body. This force usually acts on the lower plastic part 31. However, when there is no stable connection between the lower plastic part 31 and the lower support 32, the lower plastic part 31 is prone to displacement from the lower support 32, resulting in device failure. Therefore, at least the lower support 32 is added with a posterior wall 51 in the median sagittal plane, which is divided into a baffle part 511 according to its function. Its function is to increase the resistance at the dislodging position of the lower plastic part 31 and to counteract the force that causes it to dislodge, so as to keep the relative position of the lower plastic part 31 and the lower support 32 unchanged. ④ After the above structure is added, in order to overcome the influence of the gravity of the upper tray assembly 2 and improve the comfort of wearing, repeated experimental tests are conducted on the above structure, and multiple iterations are optimized, so that the above structure can play its maximum role while the patient is comfortable.

[0131] 2) Dentistry is a precise and data-based discipline, and any small difference in data (angle, weight, height, width, and softness of material, etc.) will affect the comfort and use effect of the patient. The utility model makes fine adjustment and repeated testing on these data to achieve the optimal use effect and better comfort. Through fine adjustment and data analysis and limitation of the designed structure, a more comfortable mandibular advancement device 1 is obtained, and the treatment compliance of the patient is improved. ① The upper bracket 22 and the lower bracket 32 are wider at the position of the clamping part 512 than at other positions. This improvement is based on the fact that the molars are usually wider than other parts in the oral structure, and the existing mandibular advancement device 1 does not have a corresponding widened clamping part 512. The widened clamping part 512 can make the upper and lower shapeable parts 21 and 31 more fit the patient's maxillary dentition and mandibular dentition after occlusal shaping, and the clamping of the molars is not too tight, which meets the human comfort. ② The angle of the baffle part 511 of at least the lower bracket 32 is designed in accordance with the human body structure. Since the gum and lower teeth are not vertical planes, but have a slope shape, the angled baffle part 511 matches the slope of the gum and teeth, so that the mandibular advancement device 1 of the utility model can fit the patient's oral cavity more during use, making the patient feel more comfortable. The improvement of comfort is very important for the patient. If the device is not comfortable enough or affects the treatment during use, such as part falling off, the patient will not want to wear it for a long time, which will affect the treatment. Therefore, the present technology improves the patient's compliance to a certain extent, and can make the patient's treatment more stable. ③ In addition, the present technology also makes reasonable provisions for various parameters, so that the mandibular advancement device 1 can play a more effective role during use by the patient. For example, the height of the front wall 41 is limited to make the front wall 41 not scratch the patient's gum under the premise of clamping and tightly fitting the maxillary dentition and / or mandibular dentition; the inclination angle of the front wall 41 is limited to ensure that at least the front wall 41 of the upper bracket 22 inclines to the lingual side of at least the upper shapeable part 21 during occlusion, without tightly clamping the patient's maxillary dentition to cause discomfort to the patient; the length of the baffle part 511 is limited to achieve effective support and fixation; the weight of the flexible material is limited to achieve comfort and safety while reducing the foreign body sensation in the oral cavity.

[0132] 3) The setting of the baffle part 511 improves the service life of the mandibular advancement device 1, which is economical for the patient. The mandibular advancement device 1 without the baffle part 511 is prone to cause the lower plastic part 31 to fall off, and because the upper plastic part 21 and the lower plastic part 31 are flexible materials, they are extremely easy to damage. This increases the burden and cost of the patient to frequently replace the upper plastic part 21 and the lower plastic part 31. The damage to the product not only reduces the service life of the mandibular advancement device 1, but also causes instability of the mandibular advancement device 1, thereby weakening its therapeutic effect. The mandibular advancement device 1 of the utility model sets the baffle part 511, which can effectively prevent the pulling of the two opposite forces on the lower plastic part 31 by strengthening the fixation of the lower plastic part 31 and the lower support 32, and ensure that the lower plastic part 31 will not easily fall off or be damaged during use. This improvement significantly improves the stability and service life of the device, while ensuring the stability and reliability of its therapeutic effect.

[0133] 4) Generally speaking, although the customized mandibular advancement device has a higher degree of fit with the teeth, can breathe with the mouth open, etc., the customized mandibular advancement device needs to be customized and processed by means of oral scanning and other technologies, and a large amount of labor and time cost is required, and generally a set of customized mandibular advancement device costs the patient thousands of dollars. The mandibular advancement device 1 of the utility model has the following advantages compared with the customized mandibular advancement device: a. The product of the utility model can better achieve the effect of mouth breathing of the customized mandibular advancement device and is not easy to fall off. By means of the structures such as the inclination of the front wall 41, the setting of the baffle part 511 and the clamping part 512 and the limitation of the parameters of each structure, the treatment effect of the patient is improved, and the treatment stability of the patient is ensured. b. The mandibular advancement device 1 of the utility model has a lower cost than the customized mandibular advancement device, reduces the economic pressure of the patient, and enables the patients with limited budget to use a higher-quality mandibular advancement device 1. Customization often requires the patient to pay a higher cost due to the need for precise instruments and labor. The design and output of the product of the utility model enable the patient to obtain a customized mandibular advancement device 1 at a lower cost, which is a more economical and practical choice for some patient groups. c. The mandibular advancement device 1 of the utility model can be quickly made and used, saving the waiting time of the patient for purchasing the customized mandibular advancement device 1, and being a better choice for some patients who hope to be treated quickly. d. The mandibular advancement devices on the market are often customized to have the use effect of opening the mouth. However, the non-customized mandibular advancement device 1 of the utility model can achieve the same effect, adapt to more patient needs, for example, for patients who are used to sleeping with their mouths open or patients who are prone to snoring during sleep, the mandibular advancement device 1 that can open the mouth shows its unique advantages. Not only can it provide higher comfort, but it also attracts a wider consumer group. e. The main part of the customized mandibular advancement device (i.e. the part directly contacting the teeth) is usually composed of a rigid material. The difference is that the mandibular advancement device 1 of the utility model has a flexible material in contact with the inside of the patient's mouth, which does not resist the patient's oral internal tissues, reduces the foreign body sensation in the patient's mouth when wearing the product of the utility model. At the same time, in the event of accidental collision, the flexible material acts as a buffer to protect the teeth, making it a safer mandibular advancement device 1.

[0134] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not exist, they should be considered as within the scope of the present disclosure.

[0135] The above-described embodiments only express several implementation manners of the utility model, the description is more specific and detailed, but can not therefore be understood as the limitation of the utility model patent range. It should be pointed out that for ordinary skilled person in the art, without departing from the utility model concept, several modifications and improvements can be made, which belong to the protection range of the utility model. Therefore, the protection range of the utility model patent should be subject to the appended claims.

Claims

1. A mandibular advancement device having a secure structure, characterized in that, Comprising: an upper tray assembly configured to be positioned adjacent to the patient's upper dentition when positioned in the patient's oral cavity; a lower tray assembly configured to be positioned adjacent to the patient's lower dentition when positioned in the patient's oral cavity; said upper tray assembly comprising an upper formable component and an upper support, said upper formable component and said upper support being heated to different temperatures at which they deform; said lower tray assembly comprising a lower formable component and a lower support, said lower formable component and said lower support being heated to different temperatures at which they deform; said upper support and said lower support having a labial-side proximal anterior side and a lingual-side distal posterior side, at least the upper support having a protruding anterior wall at the anterior side and at least the lower support having a protruding posterior wall at the posterior side; wherein said at least the lower support's posterior wall comprises at least a baffle portion at the mid-sagittal plane; wherein at least a portion of said at least the upper support's anterior wall is inclined towards the lingual side.

2. The mandibular advancement device of claim 1, wherein, said upper formable component and lower formable component are configured to be softened upon being heated in hot water so as to adjust and form to shapes that respectively match the patient's upper dentition and lower dentition when the patient bites.

3. The mandibular advancement device of claim 1, wherein, said upper support and lower support are made of materials having a hardness that is at least partially greater than the hardness of the materials of said upper formable component and lower formable component respectively.

4. The mandibular advancement device of claim 1, wherein, said upper support and lower support each have a bottom wall that opposes the occlusal surface of the teeth when the patient bites, said upper support's bottom wall and said lower support's bottom wall being at least partially in contact when positioned in the patient's oral cavity.

5. The mandibular advancement device of claim 1, wherein, said baffle portion has a length at the posterior side that is greater than 10% of the full length of the lower support's posterior side.

6. A mandibular advancement device having a secure structure, comprising: Comprising: an upper tray assembly having an arcuate outer shape to conform to the patient's upper dentition curvature; a lower tray assembly having an arcuate outer shape to conform to the patient's lower dentition curvature; said upper tray assembly comprising an upper formable component and an upper support, said upper formable component and said upper support being heated to different temperatures at which they deform; said lower tray assembly comprising a lower formable component and a lower support, said lower formable component and said lower support being heated to different temperatures at which they deform; said upper support and said lower support having a labial-side proximal anterior side and a lingual-side distal posterior side, said upper support and lower support having a protruding anterior wall at the anterior side and a protruding posterior wall at the posterior side; wherein at least the upper support's anterior wall and posterior wall comprise a clamping portion positioned adjacent to the molar position when positioned in the patient's oral cavity; wherein at least the lower support's posterior wall further comprises a baffle portion at the mid-sagittal plane.

7. The mandibular advancement device of claim 6, wherein, said upper tray assembly and lower tray assembly's arcuate shape is at least one of an oval arcuate shape, a tapered arcuate shape, a square arcuate shape.

8. The mandibular advancement device of claim 6, wherein, said baffle portion is divided into a plurality of spaced apart portions.

9. The mandibular advancement device of claim 6, wherein, at least the lower formable component has a shape that engages and matches said baffle portion.

10. The mandibular advancement device of claim 6, wherein, said upper formable component and lower formable component are made of formable materials that require a temperature less than 100 degrees Celsius to deform.

11. The mandibular advancement device of claim 10, wherein, said upper support and lower support are made of materials that have high temperature stability that require a temperature greater than 100 degrees Celsius to deform.

12. A mandibular advancement device having a secure structure, comprising: Comprising: an upper tray assembly configured to be positioned adjacent to the patient's upper dentition when positioned in the patient's oral cavity; The lower tray assembly is configured to be positioned adjacent to the lower dentition of the patient when positioned in the oral cavity of the patient; The upper tray assembly comprises an upper formable component and an upper holder, the upper formable component and the upper holder are heated to different temperatures for deformation; The lower tray assembly comprises a lower formable component and a lower holder, the lower formable component and the lower holder are heated to different temperatures for deformation; The upper holder and the lower holder have a front side edge close to the labial side and a rear side edge close to the lingual side, the upper holder and the lower holder have a protruding front wall at the front side edge, and the upper holder and the lower holder have a protruding rear wall at the rear side edge; At least the front wall and the rear wall of the upper holder comprise a clamping portion positioned close to the molar position when positioned in the oral cavity of the patient; At least one distance between the front wall and the rear wall of the clamping portion is greater than the distance between the front wall and the rear wall of the upper holder at other positions, and the ratio of the two distances is at least 1.12:1; At least part of the front wall of the upper holder is inclined towards the lingual side.

13. The mandibular advancement device of claim 12, wherein, The upper holder and the lower holder are respectively configured to engage and support the upper formable component and the lower formable component.

14. The mandibular advancement device of claim 12, wherein, The upper holder and the lower holder have a connecting module therebetween.

15. The mandibular advancement device of claim 14, wherein, The upper holder and the lower holder each have a bottom wall opposite the occlusal surface of the tooth when occluded, and the connecting module comprises a gear adjustment buckle arranged on the bottom wall.

16. The mandibular advancement device of claim 14, wherein, The connecting module comprises a protrusion arranged on the front wall and / or the rear wall of the upper holder and / or the lower holder.

17. A mandibular advancement device having a secure structure, comprising: Comprise: The upper tray assembly has an arcuate outer shape to conform to the curvature of the upper dentition of the patient; The lower tray assembly has an arcuate outer shape to conform to the curvature of the lower dentition of the patient; The upper tray assembly comprises an upper formable component and an upper holder, the upper formable component and the upper holder are heated to different temperatures for deformation; The lower tray assembly comprises a lower formable component and a lower holder, the lower formable component and the lower holder are heated to different temperatures for deformation; The upper holder and the lower holder have a front side edge close to the labial side and a rear side edge close to the lingual side, at least the upper holder has a protruding front wall at the front side edge, and at least the lower holder has a protruding rear wall at the rear side edge; At least the rear wall of the lower holder comprises a baffle portion at the median sagittal plane; At least the front wall of the upper holder has an outer wall towards the labial side and an inner wall opposite to the outer wall, and the angle between the inner wall of at least the front wall of the upper holder and the horizontal plane at the median sagittal plane is less than 90°; At least the front wall of the upper holder has a height of less than 19.5mm.

18. The mandibular advancement device of claim 17, wherein, The upper tray assembly and the lower tray assembly have a form of high in the middle and low on both sides.

19. The mandibular advancement device of claim 17, wherein, In the lower tray assembly, the maximum height of the baffle portion is less than or equal to the maximum height of the lower formable component.

20. The mandibular advancement device of claim 17, wherein, The projection area of the upper formable component and the lower formable component on the horizontal plane is greater than the projection area of the upper holder and the lower holder on the horizontal plane, respectively.

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