CN223081820U

CN223081820U - Mandibular advancement device

Info

Publication number: CN223081820U
Application number: CN202421715499.XU
Authority: CN
Inventors: 罗大伟
Original assignee: Shenzhen Sanyi Enterprise Technology Co ltd
Current assignee: Shenzhen Sanyi Enterprise Technology Co ltd
Priority date: 2024-07-18
Filing date: 2024-07-18
Publication date: 2025-07-11
Anticipated expiration: 2034-07-18

Abstract

The utility model relates to a mandibular advancement device comprising an upper tray assembly comprising an upper support and an upper shapeable part and a lower tray assembly comprising a lower support and a lower shapeable part. The scaffold is designed to engage with the shapeable component, which is configured to at least partially conform to the teeth and/or gums. Furthermore, the stent is composed of at least two materials having different hardness, wherein the first material is softer than the second material. The outer wall of the bracket is at least partially made of a first material, and the bottom wall of the bracket is at least partially made of a second material. This design improves the comfort and safety of the mandibular advancement device, thereby improving the user experience and enhancing the therapeutic effect.

Description

Mandibular advancement device

Technical Field

The present utility model relates to one or more of treatment and amelioration of respiratory-related disorders, and provides a mandibular advancement device.

Background

Obstructive Sleep Apnea Syndrome (OSAS) is a sleep apnea syndrome due to an upper airway obstruction lesion, defined as an adult having at least 30 apneas over a 7 hour night sleep time period, each apneas being at least 10 seconds or more, or an average number of apneas per hour being greater than 5.OSAS appears as a loud snore in sleep, short wheezing, and alternating apneas lasting more than 10 seconds. When the patient is in an apneic state, the user can generate asphyxia, sometimes can suddenly wake up, and can fall asleep again after the patient is in a respiratory state. The sleep quality is also severely affected, and patients often feel tired and sleepy during the daytime, and anxiety, depression and other manifestations can appear for patients with long disease course. The user is repeatedly subjected to hypoxia in the sleeping process, various organs and viscera are damaged for a long time, and complications of the cardiovascular system, the respiratory system, the nervous system, the endocrine system, the urinary system and the like are caused by gradual development. OSAS can be divided into light, medium and heavy according to the severity, and the purpose of treating OSAS is mainly to increase the tension of a respiratory airway, so that the respiratory airway realizes normal gas exchange, oxygen is brought into the body from the external environment, and carbon dioxide generated by metabolism is discharged out of the body. The methods of treating OSAS are generally in the form of etiology therapy, developing good lifestyle habits, medication, continuous Positive Airway Pressure (CPAP), oral appliance (MAD) therapy, surgical procedures, other instrumental interventions.

Among these several ways, CPAP therapy is the preferred option for most people, using Continuous Positive Airway Pressure (CPAP) machines that provide constant, steady pressure to the airway through hoses, masks, etc., so that the airway does not collapse due to positive pressure throughout the respiratory cycle, thereby maintaining the airway clear. However, the body of a portion of the population cannot tolerate or accommodate the positive pressure airflow provided by the CPAP machine. Secondly, CPAP requires the use of flexible tubing, masks, etc., which can be strapped to the nose, face or mouth of the user, making it difficult for the user to fall asleep, affecting sleep, and CPAP machines are relatively bulky and difficult to carry, and the user is more difficult to carry for travel. Furthermore, CPAP treatment uses a large number of components and uses a cumbersome and complicated cleaning regimen, but if improperly cleaned, may result in bacteria or fungi causing other respiratory diseases.

OSAS has also been very popular to treat by surgery. If the cause of the obstruction is clear, the obstruction can be removed by operations such as nasal polyp removal, nasal septum deflection correction, tonsil removal, adenoid removal and the like, and the oral orthognathic surgery is one of correction methods for treating OSAS caused by jaw factors, and because the forward movement of the maxilla and the mandible, the parameters such as the volume of the upper airway after the operation and the minimum cross-sectional area of the upper airway of a user are obviously increased compared with those before the operation, the OSAS symptoms can be obviously improved, and even the effect of completely disappearing the symptoms can be achieved. However, there is a risk in surgical treatment, and postoperative bleeding, infection, poor postoperative effect, and the like may occur.

Thus, CPAP and/or surgical treatment may not be the optimal treatment for OSAS.

Oral appliance (MAD) treatment is to indirectly enlarge the upper airway by advancing the mandible, thereby achieving a therapeutic effect. MAD treatment can be divided into three general categories, depending on the site of action, soft palate effector (SPL), tongue Retractor (TRD), and mandibular advancement device. The soft palate effector is fixed on the maxillary teeth and extends backwards to directly act on the soft palate and the uvula, reduce the sagging of the soft palate and the uvula, reduce the contact between the overlong soft palate and the uvula and the tongue root and the back pharyngeal wall, prevent the pharyngeal stenosis or obstruction, and simultaneously reduce the vibration of the soft palate to reduce the snoring. However, the soft palate is touched to cause nausea and needs a long training time to be tolerated, so that the soft palate is rarely used. The tongue tractor attracts the tongue to move forward through the negative pressure generated in the ball in front of the appliance, and can prevent the tongue from falling backwards, thereby achieving the effect of widening the posterior tongue and the posterior soft palate airway. However, tongue retractors are less comfortable and secure and are less tolerated by the user and therefore less useful. The mandibular advancement device enlarges the oropharyngeal cavity by keeping the mandible in a forward extending state and indirectly drives the tongue body to advance, so that the back air passage of the tongue is widened, the backward compression of the tongue on the soft palate can be reduced, and the back air passage of the soft palate is widened. The adjustable mandibular advancement device is more common, if the treatment effect is poor, the mandibular advancement distance can be increased, the airway can be enlarged, and if discomfort occurs in the treatment process, the advancement amplitude can be reduced. The adjustable mandibular advancement device can not only improve the tolerance of a user, but also achieve an effective treatment effect.

While there are challenges in the design of mandibular advancement devices, 1) robustness, which may cause the mandibular advancement device to fall off during sleep, or unintentional opening and closing of the mouth, thereby affecting the sustainability of the treatment, 2) applicability, which is a great challenge in designing mandibular advancement devices suitable for most people due to the different shapes and sizes of the mouth and teeth of each person, and the high cost of customizing mandibular advancement devices, and 3) comfort, which may cause problems of tooth discomfort when the mandibular advancement device is occluded, the cheek interior and tongue are easily scraped with the mandibular advancement device, and the mandibular advancement device is worn for a long period of time.

Thus, to overcome these challenges and design a more robust, adaptable and comfortable mandibular advancement device for most people, a comprehensive design is required. This includes, but is not limited to, consideration of material selection to ensure that the mandibular advancement device is sufficiently strong and comfortable while being suitably flexible to accommodate different oral morphologies. By comprehensively considering these factors, the therapeutic effect and the use comfort of the mandibular advancement device can be improved, thereby better meeting the requirements of users.

Disclosure of utility model

To solve the above-mentioned problems, the present utility model provides a mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

An upper tray assembly configured to be adjacent to a portion of the upper dentition of a user, comprising an upper support and an upper shapeable component;

A lower tray assembly configured to be adjacent to a portion of the lower dentition of a user, comprising a lower support and a lower shapeable component;

Wherein the upper and lower brackets are configured to engage and support the upper and lower shapeable components, respectively;

The upper and lower shapeable parts are configured to at least partially conform to teeth and/or gums;

The upper bracket and the lower bracket are at least provided with two materials with different hardness, and the hardness of the first material is lower than that of the second material;

The upper bracket and the lower bracket are provided with bottom walls;

The bottom wall of the upper bracket is provided with a first end and a second end, and an approximate arc shape is formed between the first end and the second end at least partially;

The bottom wall of the lower bracket is provided with a third end and a fourth end, and an approximate arc shape is formed between the third end and the fourth end at least partially.

In one embodiment, the upper tray assembly is approximately arcuate, U-shaped, or arched in shape.

In one embodiment, the lower tray assembly is approximately arcuate, U-shaped, or arched in shape.

In one embodiment, the first, second, third, and fourth ends comprise the first material.

In one embodiment, the second material has a higher hardness than the first material.

The utility model also discloses a mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

the upper bracket and the lower bracket are provided with outer walls;

wherein the outer wall comprises at least in part the first material.

In one embodiment, the outer wall comprises only the first material.

In one embodiment, the area of the first material is greater than the area of the second material in the portion of the outer wall that contacts the oral cavity.

In one embodiment, the first material comprises silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA.

In one embodiment, the second material comprises PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nickel titanium alloy, aluminum alloy.

In one embodiment, the outer wall forms an angle of 20-150 ° with the horizontal.

The upper bracket and the lower bracket are provided with bottom walls;

wherein the bottom wall comprises at least in part the second material.

In one embodiment, the bottom wall comprises only the second material.

In one embodiment, the thickness of the second material in the bottom wall is at least 0.3mm.

In one embodiment, the projected area of the bottom wall on the horizontal plane is at least 9cm ².

In one embodiment, the first material and the second material are fixed by crimping, over-molding, buckling, bonding, hot melting, screws and hooks.

The utility model further discloses a mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

the upper bracket and the lower bracket are provided with a bottom wall and an outer wall;

The upper and lower brackets have one or more of the following characteristics:

The volume ratio of the first material to the second material is in the range of 0.05-20;

The thickness of at least part of the outer wall ranges from 0.3mm to 6mm;

the bottom wall has at least a portion of a thickness in the range of 0.3-6mm.

In one embodiment, the height of the middle of the outer wall is greater than the height of the two ends of the outer wall.

In one embodiment, the width of the middle of the outer wall is smaller than the width of the two ends of the outer wall.

In one embodiment, the upper bracket includes a first outer wall and a second outer wall, and the lower bracket includes a third outer wall and a fourth outer wall.

In one embodiment, the second outer wall comprises only the first material and the first outer wall comprises the second material.

In one embodiment, the third outer wall comprises only the first material and the fourth outer wall comprises the second material.

The mandibular advancement device embodying the utility model has at least the following beneficial effects:

1) The stents of existing mandibular advancement devices on the market are generally made of only one material. A stent made of only rigid material, the exposed rigid portion of which is prone to scratch the inside of the mouth during wear, resulting in irritation or even injury to the soft tissue or tongue inside the mouth. Second, if the mandibular advancement device is made entirely of only shapeable or other softer materials, insufficient support during occlusion may result. In addition, the lower tray assembly needs to move forward relative to the upper tray assembly, the upper tray assembly and the lower tray assembly need to be fixed with each other, softer materials are easy to deform, the forward moving distance can be changed, the upper tray assembly and the lower tray assembly can be separated easily, and the treatment effect can be affected. In order to solve the problem, the utility model adopts an innovative design that the bracket is at least made of two materials with different hardness. The outer wall of the support is mainly made of a first material, and the first material is softer and is beneficial to reducing scratch to the inside of the oral cavity in the wearing process. The bottom wall of the bracket is at least partially made of a second, higher durometer material that provides the support force required during occlusion and stability to secure the bracket. In addition, a certain angle is formed between the outer wall of the bracket and the horizontal plane, so that the bracket can adapt to the natural angle that the front teeth incline to the labia and is more fit with the shape of the teeth. Through the design, the supporting force in the occlusion process is ensured, the upper tray component and the lower tray component can be firmly connected, and the possibility of falling off of the device is reduced, so that the mandibular advancement device is ensured to have a good effect in the treatment process.

2) When a user uses the mandibular advancement device, the lower tray assembly is advanced relative to the upper tray assembly to achieve the mandibular advancement effect. However, the forward movement may cause crowding of the inside of the oral cavity, and particularly when the forward movement distance is large, may cause deep oral cavity to contact with the stent, causing a feeling of soreness and foreign body sensation. Thus, the stent outer wall is mostly made of the first material. Compared with the traditional rigid material, the first material is softer and more easily deformed, and can better fit the shape inside the oral cavity, thereby providing more comfortable wearing experience. In addition, the two ends of the support are also made of softer first materials so as to ensure the comfort of the mandibular joint and/or the deep oral cavity. This design helps to improve the comfort of use of the mandibular advancement device and reduces discomfort to the user, improving the user experience and thus better improving the therapeutic effect.

3) Mandibular advancement devices are often required to be worn during sleep for extended periods of time, which may lead to soreness of the user's mouth or teeth. In addition, when the mandibular advancement device is worn, the lower tray assembly is advanced relative to the upper tray assembly to achieve the mandibular advancement effect. In the forward movement process, the lower dentition is subjected to forward movement traction, the lower tray component is subjected to shape restoration reaction force of the lower dentition, the upper dentition is subjected to backward movement traction, and the upper tray component is subjected to shape restoration reaction force of the upper dentition. Thus, the larger force bearing surface of the lower tray assembly faces lingual side and the larger force bearing surface of the upper tray assembly faces labial side. The present utility model provides an improved stent design where the outer wall of the stent is made of different materials for different directions of force and the portion that is prone to contact soft tissue of the oral cavity is mostly made of a softer first material. Compared with the traditional integrated rigid material, the design can provide a more comfortable stress surface, relieve discomfort of the oral cavity and teeth, and improve user experience of a user.

4) The problem of easy falling off of the mandibular advancement device in the existing market still exists, and a large number of user feedback indicates that the mandibular advancement device is often separated from the oral cavity during sleeping, resulting in falling off of the device. It has been found through test analysis that this problem of removal is mainly due to the need for the lower tray assembly to be advanced relative to the upper tray assembly, and that the user may move or unintentionally open and close the mouth during sleep, which may result in the mandibular advancement device being prone to removal. In addition, the outer walls of the brackets on the market are mostly made of rigid materials, and the exposed rigid materials are easy to slide after contacting with the oral cavity, so that the possibility of the mandibular advancement device falling off is further increased. To address this problem, the present utility model provides an improved stent design having an outer wall comprising a softer first material. The first material has a greater coefficient of friction than conventional rigid materials, thereby increasing friction with the oral cavity. By increasing the friction, the mandibular advancement device can be more firmly secured in the mouth, reducing the likelihood of loss, improving the stability and sustainability of the device during sleep.

Drawings

FIG. 1 is a schematic view of a mandibular advancement device according to an embodiment of the present utility model;

FIG. 2 is an exploded view of a mandibular advancement device according to various embodiments of the present utility model;

FIG. 3 is a schematic view of a horizontal, sagittal, coronal plane in various embodiments of the present utility model;

FIG. 4 is a top view of the upper and lower brackets separated in various embodiments of the utility model;

FIG. 5 is a cross-sectional view of the upper bracket in the direction A-A of FIG. 4 in one embodiment of the utility model;

FIG. 6 is a rear view of an upper bracket and lower bracket combination in accordance with various embodiments of the present utility model;

FIG. 7 is a cross-sectional view of the stent in the direction D-D in FIG. 6 in one embodiment of the utility model;

FIG. 8 is a cross-sectional view of the upper rack in the direction B-B in FIG. 4 in one embodiment of the utility model;

FIG. 9 is a schematic partial cross-sectional view of the outer wall of the bracket in the first embodiment of the utility model in an angle with the horizontal plane;

FIG. 10 is a schematic cross-sectional view of the upper rack in the direction A-A and the direction C-C of FIG. 4 in a first embodiment of the utility model;

FIG. 11 is a schematic partial cross-sectional view of the outer wall of the stent in the first embodiment of the present utility model;

FIG. 12 is a schematic partial cross-sectional view of the outer wall of the stent in a second embodiment of the present utility model;

Fig. 13 is a schematic partial cross-sectional view of the outer wall of the stent in the second embodiment of the present utility model.

Detailed Description

In order that the above objects, features and advantages of the utility model will be readily understood, a more particular description of the utility model will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present utility model. The present utility model may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the utility model, whereby the utility model is not limited to the specific embodiments disclosed below.

The utility model relates to a mandibular advancement device, which aims at the limitation that most mandibular advancement device brackets on the market are made of only one material. In order to solve the problem, the utility model adopts an innovative design, namely the bracket of the mandibular advancement device is made of two materials with different hardness. By this design, the comfort and safety of the mandibular advancement device can be improved, thereby improving the user experience and enhancing the therapeutic effect.

The present utility model provides a mandibular advancement device 1 for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a portion of the upper dentition of a user, and includes an upper bracket 21 and an upper shapeable segment 22, the primary function of which is to support the teeth of the upper jaw. The lower tray assembly 3 is configured to be adjacent to a portion of the lower dentition of a user, and includes a lower bracket 31 and a lower shapeable component 32, the primary function of which is to support the teeth of the mandible. Wherein the upper tray assembly 2 and the lower tray assembly 3 are approximately arc-shaped, U-shaped or arched in shape, conforming to the general arch of the dentition curve of the user. The upper tray assembly 2 and the lower tray assembly 3 together constitute the mandibular advancement device 1, and achieve the effect of treating OSAS by supporting and adjusting the anterior-posterior distance of the maxillary dentition and applying a slight pressure to the teeth.

The upper and lower plastic parts 22, 32 are configured to at least partially conform to the teeth and/or gums. The upper and lower shapeable members 22, 32 are generally approximately arcuate, U-shaped or arched, similar to the shape of a dental arch, to ensure that the upper and lower shapeable members 22, 32 are in sufficient contact with the teeth, gums. Portions of the upper and lower shapeable members 22, 32 may have a convex or concave design to accommodate the different size and shape of the teeth. The upper and lower shapable parts 22, 32 are typically made of elastomeric materials such as silicone rubber, PU, PVA, EVA, etc., which require good biocompatibility, are soft and comfortable, do not cause damage to the oral cavity, and are suitable for long-term wear in the oral cavity.

There are several different types of shapable parts on the market at present, and it is common to make them in hospitals according to the dental impressions of the users, so that the shapable parts can be precisely customized, and can be better fitted to the teeth of the users, thereby ensuring better comfort and optimal therapeutic effect. However, custom-made shapable parts require specialized techniques and equipment, are costly, require a long period of time, and can be difficult to manufacture, and require reworking or machining if significant adjustments or changes are required. Therefore, a hot-melt moldable part is also popular in the market, the manufacturing process of the hot-melt moldable part is relatively simple, the material is only required to be heated and softened, the required shape is molded in a biting way, and the shape can be reheated to be adjusted in a small extent after the shaping, so that the manufacturing speed is higher, and the cost is reduced. Because of the simple manufacturing process and lack of specialized equipment assistance, the precision and suitability of hot melt shapable parts may be low and there may be limitations in the choice of materials, requiring the use of special materials for hot melt, but these materials may have limitations in terms of hardness, comfort, etc. The upper and lower shapeable members 22, 32 provided in the present utility model include, but are not limited to, custom shapeable members and hot melt shapeable members.

Specifically, referring to fig. 1 to 4, the upper and lower brackets 21 and 31 are configured to engage and support the upper and lower shapable members 22 and 32, respectively, to provide stable supporting force in the mouth of a user, and may also have an adjusting function to allow adjustment according to the needs of the user. The shape of the upper and lower brackets 21, 31 is generally similar to the upper and lower shapeable segments 22, 32, again in a generally arcuate, U-shaped or arched shape to ensure a conforming shape to the teeth within the mouth.

The upper and lower brackets 21, 31 have at least two materials of different hardness, the first material 4 having a lower hardness than the second material 5. The first material 4 is typically a material having softness and good elasticity, including but not limited to silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA. The first material 4 is generally biocompatible, capable of contacting the interior of the mouth without causing allergies or other adverse reactions, and the soft material is more comfortable than conventional rigid materials, more suitable for long-term wear engagement, and helps to reduce discomfort and oral irritation for the user. Although the first material 4 is relatively soft, it also has a certain wear resistance and is able to withstand the tension and friction forces in the mouth when worn, thereby increasing the service life of the overall component. The second material 5 has a higher hardness than the first material 4, and is generally strong, and can withstand a larger pressure, so that the upper bracket 21 and the lower bracket 31 are not easy to deform or break during the wearing and biting process, and the structural stability of the bracket is maintained. The second material 5 includes, but is not limited to PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nickel titanium alloy, aluminum alloy.

As shown in fig. 5, the first material 4 and the second material 5 on the upper bracket 21 and the lower bracket 31 are usually fixed in a non-detachable manner, and may be fixed by crimping (applying pressure to tightly bond the two), overmolding, snap-fitting (respectively, the snap-fitting is configured on the first material 4 and the second material 5 to be joined), bonding (such as an adhesive), hot melting (heating the first material 4 to be cooled and fixed on the second material 5 after melting), or using an additional fixing member such as a screw, a hook, or the like. The connection means may take one form or even two or more forms may be combined to fulfil the function of connecting and/or fixing the first material 4 and the second material 5. The selection of the appropriate connection will depend on the specific design requirements, material characteristics and use environment to ensure a secure, reliable, durable connection, and to facilitate installation during production and adjustment by the user. Among them, the preferred fixing means is over-molding. The overmolding can tightly fix the first material 4 and the second material 5 together, providing a more secure fixing effect, avoiding falling off or loosening between the materials, and secondly, also preventing foreign substances from entering or remaining in the gaps between the materials, such tightness can effectively protect the inside of the materials from residual bacteria or cleaning residual substances, and also can prolong the service life.

The upper and lower brackets 21, 31 include bottom walls 211, 311. As shown in fig. 6 and 7, the bottom walls 211 and 311 are generally horizontal, the top of the bottom walls 211 and 311 are attached to the upper and lower shapeable parts 22 and 32, and the bottom forms a channel with the bottom of the other bottom wall 211 and 311. When the user wears the mandibular advancement device 1, the device is not completely closed, and external air flow can enter the oral cavity of the user from the channel, so that the free flow of the air flow in the oral cavity of the user is not limited. Meanwhile, the use requirement of a user who is used to breathe with the mouth during sleeping is met, and the risk of asphyxia is avoided. If the upper and lower shapeable members 22, 32 are used, which require shaping by biting into the upper and lower tray assemblies 2, 3, not providing sufficient vertical support force, the shaping process may be difficult or even failed. Second, the lower tray assembly 3 needs to be moved forward relative to the upper tray assembly 2, and the upper and lower brackets 21 and 31 need to be fixed to each other, and if a softer material is used, the softer material is easily deformed, resulting in a change in the forward movement distance, which affects the treatment effect and also results in easy separation of the upper and lower brackets 21 and 31. Accordingly, the present utility model provides an improved upper and lower brackets 21, 31 having bottom walls 211, 311 at least partially formed of the second material 5 that provide sufficient vertical support for the upper and lower shapeable segments 22, 32. The area of the bottom walls 211, 311 in the horizontal plane is at least 9cm ² and at least part of the thickness is in the range of 0.3-6mm, i.e. d1 as shown in fig. 7. The thickness of the second material 5 contained in the bottom walls 211, 311 is at least 0.3mm, d2 shown in fig. 7. The sum of the total weight of the upper bracket 21 and the lower bracket 31 is 3-50g, and the volume ratio of the first material 4 to the second material 5 in the upper bracket 21 and the lower bracket 31 is 0.05-20. Preferably, the bracket bottom walls 211, 311 comprise only the second material 5 with a thickness of 1-2mm. By this design, not only the supporting force and rigidity required for the mandibular advancement device 1 can be ensured, but also the upper bracket 21 and the lower bracket 31 can be prevented from being too thick, thereby reducing the weight of the mandibular advancement device 1 and the burden on the oral cavity.

As shown in fig. 4 and 8, the upper bracket bottom wall 211 has a first end 214 and a second end 215, wherein the first end 214 and the second end 215 form an approximate arc shape, a U shape or an arch shape at least partially, and the lower bracket bottom wall 311 has a third end 314 and a fourth end 315, wherein the third end 314 and the fourth end 315 form an approximate arc shape, a U shape or an arch shape at least partially. When the user uses the mandibular advancement device 1, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve mandibular advancement. However, the forward movement may cause crowding of the inside of the oral cavity, and particularly when the forward movement distance is large, may cause deep contact of the oral cavity with the upper and lower brackets 21 and 31, causing a feeling of soreness and foreign body sensation. Thus, the stent ends 214, 215, 314, 315 are made of a softer first material 4 to ensure comfort of the mandibular joint and/or deep oral cavity. This design helps to improve the comfort of use of the mandibular advancement device 1 and to reduce discomfort for the user and to improve the user experience and thus better improve the therapeutic effect.

The upper and lower brackets 21, 31 include outer walls 212, 213, 312, 313. As shown in fig. 6 to 8, the outer walls 212, 213, 312, 313 of the stent are at least partially composed of a relatively soft first material 4, the area of the first material 4 being larger than the area of the second material 5 in the portions of the outer walls 212, 213, 312, 313 that are in contact with the oral cavity. The first material 4 is more deformable and better conforms to the shape of the interior of the mouth than conventional rigid materials, thereby providing a more comfortable wearing experience.

When the mandibular advancement device 1 is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve mandibular advancement, and in the process of the advancement, the lower dentition is subjected to forward traction, the lower tray assembly 3 is subjected to the reaction force of the restoration of the shape of the lower dentition, the upper dentition is subjected to backward traction, and the upper tray assembly 2 is subjected to the reaction force of the restoration of the shape of the upper dentition. The force-bearing surface of the lower tray assembly 3 is thus positioned near the lingual side, the force-bearing surface of the upper tray assembly 2 is positioned near the labial side, and the reaction force exerted by the upper tray assembly 2 is less than the reaction force exerted by the lower tray assembly 3 because the upper tray assembly 2 is offset less from the original position of the teeth. The problem of easy falling off of the mandibular advancement device in the existing market still exists, and a large number of user feedback indicates that the mandibular advancement device is often separated from the oral cavity during sleeping, resulting in falling off of the device. Tests and analyses have found that this problem of disengagement is mainly due to the fact that the lower tray assembly needs to be advanced relative to the upper tray assembly, and that the user may move or unintentionally open and close his mouth during sleep, and that the lack of the outer wall of the support frame results in insufficient support, which may lead to a lower jaw advancement device that is prone to disengagement. In addition, the outer walls of the brackets on the market are mostly made of rigid materials, and the exposed rigid materials are easy to slide after contacting with the oral cavity, so that the possibility of the mandibular advancement device falling off is further increased.

To solve these problems, the upper and lower brackets 21, 31 of the present utility model have outer walls 212, 213, 312, 313 to provide a sufficient supporting force for the mandibular advancement device 1. Furthermore, the portions of the outer walls 212, 213, 312, 313 that contact the oral cavity are mostly made of the first material 4. The first material 4 has a higher coefficient of friction than conventional rigid materials, thereby increasing friction with the oral cavity. By increasing the friction, the mandibular advancement device 1 can be more firmly secured in the mouth, reducing the likelihood of falling out, improving the stability and sustainability of the device during sleep. This design helps to improve the comfort of use of the mandibular advancement device 1 and to reduce discomfort for the user and to improve the user experience and thus better improve the therapeutic effect.

Several structures of the mandibular advancement device 1 according to the utility model are described below in connection with specific examples.

Example 1

The mandibular advancement device 1 of the present embodiment comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a portion of the upper dentition of a user, and includes an upper bracket 21 and an upper shapeable component 22. The lower tray assembly 3 is configured to be adjacent to a portion of the lower dentition of a user, including a lower support 31 and a lower shapeable component 32.

Specifically, as shown in FIG. 2, the upper and lower moldable members 22 and 32 are configured to at least partially conform to teeth and/or gums. The upper and lower brackets 21 and 31 are configured to engage and support the upper and lower shapeable members 22 and 32, respectively. The upper and lower brackets 21, 31 have at least two materials of different hardness, the first material 4 having a lower hardness than the second material 5.

The upper and lower brackets 21, 31 include bottom walls 211, 311 and outer walls 212, 213, 312, 313. As shown in fig. 4 and 6, the upper bracket 21 includes a bottom wall 211, a first outer wall 212, and a second outer wall 213, and the lower bracket 31 includes a bottom wall 311, a third outer wall 312, and a fourth outer wall 313, the first outer wall 212, the third outer wall 312 being disposed toward the labial side, and the second outer wall 213, the fourth outer wall 313 being disposed toward the lingual side.

In the present embodiment, the holder outer walls 212, 213, 312, 313 and the bottom walls 211, 311 are interconnected, as shown in fig. 9, by the structures of the first outer wall 212-the bottom wall 211-the second outer wall 213, the third outer wall 312-the bottom wall 311-the fourth outer wall 313 contacting the upper shapable member 22 and the lower shapable member 32. Each tooth has a certain angular difference and is not necessarily perpendicular to the horizontal plane. For example, the anterior teeth (central incisors and lateral incisors) are typically inclined labially at an angle of about 10-25 ° relative to the horizontal vertical plane, the canine teeth (labial direction) are typically inclined at an angle of between 5-15 °, and the molar teeth are typically inclined at an angle of between 0-5 °. The anterior and canine teeth are angled at a greater angle relative to the horizontal vertical plane and the molar teeth are angled at a lesser angle relative to the horizontal vertical plane, which results in different teeth requiring different support forces during occlusion. Thus, the outer walls 212, 213, 312, 313 form an angle (towards the direction away from the bottom walls 211, 311) of 20 ° -150 ° with the horizontal plane, i.e. an angle α in fig. 9, wherein it is preferred that the outer walls 212, 213, 312, 313 form an angle of 45-90 ° with the horizontal plane.

The positions of the teeth in the mouth are different, and the height and width of the outer walls 212, 213, 312, 313 are adjusted accordingly to account for the differences in the size of the different teeth. The central incisor portion is generally narrower and longer, suitable for cutting and tearing food, and the molar portion is generally wider and thicker, more suitable for chewing and grinding food. Thus, as shown in fig. 10, the outer walls 212, 213, 312, 313 are generally high in the middle (at the sagittal tangent point) and narrow in the anteroposterior distance (the distance between the first outer wall 212 and the second outer wall 213 or the distance between the third outer wall 312 and the fourth outer wall 313) and wide in the anteroposterior distance, i.e., the height between the outer walls 212, 213, 312, 313 is greater than the height of the two ends (h 1 in fig. 10), and the width of the middle is smaller than the width of the two ends (w 1 in fig. 10). The middle, higher, narrower portion can receive and secure the narrower, longer, central incisors, and the molar portions, while also being longer, are wider and thicker, being configured to be lower at both ends and wider, to avoid over-width crushing of the outer walls 212, 213, 312, 313.

When the mandibular advancement device 1 is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve mandibular advancement, as shown in fig. 11, during which the lower dentition is subjected to an advancing traction force, the lower bracket 31 is subjected to a reaction force of the restoration shape of the lower dentition, the upper dentition is subjected to a retracting traction force, and the upper bracket 21 is subjected to a reaction force of the restoration shape of the upper dentition. Therefore, the force receiving surface of the lower bracket 31 is positioned near the lingual side, the force receiving surface of the upper bracket 21 is positioned near the labial side, and the reaction force received by the upper bracket 21 is smaller than the reaction force received by the lower bracket 31 because the upper bracket 21 is offset by a small amount from the original position of the tooth. Thus, the larger force-receiving surface of the upper bracket 21 is the first outer wall 212, and the larger force-receiving surface of the lower bracket 31 is the fourth outer wall 313.

In the present embodiment, the first material 4 is low in hardness, it is difficult to provide a sufficient supporting force, and the portions of the outer walls 212, 213, 312, 313 of the bracket that contact the oral cavity are mostly composed of the first material 4 and at least partially include the second material 5, i.e., the first outer wall 212 and the second outer wall 213 at least partially include the first material 4 and the second material 5, and the third outer wall 312 and the fourth outer wall 313 at least partially include the first material 4 and the second material 5. Wherein the thickness of at least part of the outer walls 212, 213, 312, 313 is in the range of 0.3-6mm, i.e. w2 in fig. 12, preferably the thickness of the outer walls 212, 213, 312, 313 is 1.2-2mm, and the thickness of the second material 5 in the first outer wall 212, the second outer wall 213, the third outer wall 312, the fourth outer wall 313 is 1mm, i.e. w3 in fig. 12. This design ensures the required supporting force without being too heavy and retains the comfort of the first material 4 to the oral cavity, thereby avoiding an increase in the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

The support force required for the upper and lower tray assemblies 2, 3 is different due to the different characteristics of the materials. In other embodiments, the bracket outer walls 212, 213, 312, 313 may be differently configured, as the upper bracket 21 may not have the first outer wall 212 and/or the second outer wall 213, and the lower bracket 31 may not have the third outer wall 312 and/or the fourth outer wall 313.

Example 2

When the mandibular advancement device is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve mandibular advancement, and during the advancement process, the lower dentition is subjected to forward traction, the lower bracket 31 is subjected to the reaction force of the restoration shape of the lower dentition, the upper dentition is subjected to backward traction, and the upper bracket 21 is subjected to the reaction force of the restoration shape of the upper dentition. Therefore, the force receiving surface of the lower bracket 31 is positioned near the lingual side, the force receiving surface of the upper bracket 21 is positioned near the labial side, and the reaction force received by the upper bracket 21 is smaller than the reaction force received by the lower bracket 31 because the upper bracket 21 is offset by a small amount from the original position of the tooth. Thus, the larger force-receiving surface of the upper bracket 21 is the first outer wall 212, and the larger force-receiving surface of the lower bracket 31 is the fourth outer wall 313.

In this embodiment, the first material 4 has a certain hardness, which can provide a part of the supporting force, but still needs to provide more supporting force on the larger stress surface by the second material 5. As shown in fig. 12, the first outer wall 212 and the fourth outer wall 313 include the second material 5 and the first material 4, and the second outer wall 213 and the third outer wall 312 include only the first material 4. The outer walls 212, 313 are formed by the second material 5 and the first material 4 together on the larger stress surface to provide enough supporting force, and the first material 4 is only needed to provide supporting force for the outer walls 213, 312 on the smaller stress surface. Wherein the thickness of at least part of the outer walls 212, 213, 312, 313 is in the range of 0.3-6mm, i.e. w2 in fig. 12, preferably the thickness of the outer walls 212, 213, 312, 313 is 1.2-2mm, and the thickness of the second material 5 in the first outer wall 212 and the fourth outer wall 313 is 1mm, i.e. w3 in fig. 12. This design ensures the required supporting force without being too heavy and retains the comfort of the first material 4 to the oral cavity, thereby avoiding an increase in the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

Example 3

The mandibular advancement device 1 of the present embodiment comprises an upper tray assembly 2 and a lower tray assembly 3. The upper tray assembly 2 is configured to be adjacent to a portion of the upper dentition of a user, and includes an upper bracket 21 and an upper shapeable component 22. The lower tray assembly 3 is configured to be adjacent to a portion of the lower dentition of a user, including a lower support 31 and a lower shapeable component 32. Specifically, as shown in FIG. 2, the upper and lower moldable members 22 and 32 are configured to at least partially conform to teeth and/or gums. The upper and lower brackets 21 and 31 are configured to engage and support the upper and lower shapeable members 22 and 32, respectively. The upper and lower brackets 21, 31 have at least two materials of different hardness, the first material 4 having a lower hardness than the second material 5.

In the present embodiment, the first material 4 has a large hardness, and can provide a sufficient supporting force. As shown in fig. 13, the first outer wall 212, the second outer wall 213, the third outer wall 312, and the fourth outer wall 313 include only the first material 4. Wherein the outer walls 212, 213, 312, 313 have at least a part of a thickness in the range of 0.3-6mm, i.e. w2 in fig. 13, preferably the outer walls 212, 213, 312, 313 have a thickness in the range of 1.2-2mm. This design ensures the required supporting force without being too heavy and retains the comfort of the first material 4 to the oral cavity, thereby avoiding an increase in the weight of the mandibular advancement device 1 and reducing the burden on the oral cavity.

In addition, the technical features in the above embodiments may be combined as necessary to obtain the mandibular advancement device 1 including all or part of the technical features described above.

The mandibular advancement device 1 embodying the utility model has at least the following beneficial effects:

1) The stents of existing mandibular advancement devices on the market are generally made of only one material. A stent made of only rigid material, the exposed rigid portion of which is prone to scratch the inside of the mouth during wear, resulting in irritation or even injury to the soft tissue or tongue inside the mouth. Second, if the mandibular advancement device 1 is made entirely of only shapeable or other softer material, this may result in insufficient support during occlusion. In addition, the lower tray assembly 3 needs to move forward relative to the upper tray assembly 2, the upper tray assembly 2 and the lower tray assembly are fixed with each other, the softer material is easy to deform, the forward moving distance can be changed, the upper tray assembly 2 and the lower tray assembly 3 can be easily separated, and the treatment effect can be affected. To solve this problem, the present utility model employs an innovative design in which the upper and lower brackets 21 and 31 have at least two materials having different hardness. The outer walls 212, 213, 312, 313 of the support are mainly made of a first material 4, and the first material 4 is soft and helps to reduce scraping of the inside of the oral cavity during wearing. The bracket bottom walls 211, 311 are at least partially made of a second material 5 of a higher hardness, which second material 5 provides the support force required during the snap-in process and the stability of the fixed upper and lower brackets 21, 31. In addition, the bracket outer walls 212, 213, 312, 313 form a certain angle with the horizontal plane, so that the bracket can adapt to the natural angle that the front teeth incline to the labia, and further adapt to the shape of the teeth. Through the design, the supporting force in the occlusion process is ensured, the upper tray component 2 and the lower tray component 3 can be firmly connected, the possibility of falling off of the device is reduced, and therefore, the mandibular advancement device 1 is ensured to have a good effect in the treatment process.

2) When the user uses the mandibular advancement device 1, the lower tray assembly 3 is advanced relative to the upper tray assembly 1 to achieve mandibular advancement. However, the forward movement may cause crowding of the inside of the oral cavity, and particularly when the forward movement distance is large, may cause deep oral cavity to contact with the stent, causing a feeling of soreness and foreign body sensation. Thus, the bracket outer walls 212, 213, 312, 313 are mostly made of the first material 4. Compared with the traditional rigid material, the first material 4 is softer and more easily deformed, and can better fit the shape of the inside of the oral cavity, thereby providing more comfortable wearing experience. In addition, the stent ends 214, 215, 314, 315 also employ a softer first material 4 to ensure comfort in the mandibular joint and/or deep mouth. This design helps to improve the comfort of use of the mandibular advancement device 1 and to reduce discomfort for the user and to improve the user experience and thus better improve the therapeutic effect.

3) Mandibular advancement device 1 is typically required to be worn during sleep for a long period of time, which may lead to soreness of the user's mouth or teeth. In addition, when the mandibular advancement device 1 is worn, the lower tray assembly 3 is advanced relative to the upper tray assembly 2 to achieve the mandibular advancement effect. During the forward movement, the lower dentition is subjected to forward traction, the lower tray assembly 3 is subjected to shape restoration reaction force of the lower dentition, the upper dentition is subjected to backward traction, and the upper tray assembly 2 is subjected to shape restoration reaction force of the upper dentition. Thus, the larger force-receiving surface of the lower tray assembly 3 faces lingual side and the larger force-receiving surface of the upper tray assembly 2 faces labial side. The present utility model provides an improved stent design in which the outer stent walls 212, 213, 312, 313 are made of different materials for different directions of force and the portions that are likely to contact soft tissues of the oral cavity are made of the softer first material 4. Compared with the traditional integrated rigid material, the design can provide a more comfortable stress surface, relieve discomfort of the oral cavity and teeth, and improve user experience of a user.

4) The problem of easy falling off of the mandibular advancement device in the existing market still exists, and a large number of user feedback indicates that the mandibular advancement device is often separated from the oral cavity during sleeping, resulting in falling off of the device. It has been found through test analysis that this problem of removal is mainly due to the need for the lower tray assembly to be advanced relative to the upper tray assembly, and that the user may move or unintentionally open and close the mouth during sleep, which may result in the mandibular advancement device being prone to removal. In addition, the outer walls of the brackets on the market are mostly made of rigid materials, and the exposed rigid materials are easy to slide after contacting with the oral cavity, so that the possibility of the mandibular advancement device falling off is further increased. To solve this problem, the present utility model provides an improved stent design, the outer walls 212, 213, 312, 313 of which comprise a softer first material 4. The first material 4 has a higher coefficient of friction than conventional rigid materials, thereby increasing friction with the oral cavity. By increasing the friction, the mandibular advancement device 1 can be more firmly secured in the mouth, reducing the likelihood of falling out, improving the stability and sustainability of the device during sleep.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the utility model, which are described in detail and are not to be construed as limiting the scope of the utility model. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the utility model, which are all within the scope of the utility model. Accordingly, the scope of protection of the present utility model is to be determined by the appended claims.

Claims

1. A mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

The upper bracket and the lower bracket are provided with bottom walls;

2. The mandibular advancement device according to claim 1, wherein the upper tray assembly is approximately arc-shaped, U-shaped or arched in shape.

3. The mandibular advancement device according to claim 1, wherein the lower tray assembly is approximately arc-shaped, U-shaped or arched in shape.

4. The mandibular advancement device according to claim 1, wherein the first, second, third and fourth ends comprise the first material.

5. The mandibular advancement device according to claim 1, wherein the second material has a higher hardness than the first material.

6. A mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

the upper bracket and the lower bracket are provided with outer walls;

wherein the outer wall comprises at least in part the first material.

7. The mandibular advancement device according to claim 6, wherein the outer wall comprises only the first material.

8. The mandibular advancement device according to claim 6, wherein the area of the first material is larger than the area of the second material in the portion of the outer wall that contacts the oral cavity.

9. The mandibular advancement device according to claim 6, wherein the first material comprises silicone rubber, PVA, PU, EVA, TPO, TPE, TPR, PLA, PLGA.

10. The mandibular advancement device according to claim 6, wherein the second material comprises PC, PP, ABS, PE, PMMA, PU, stainless steel, titanium alloy, nickel titanium alloy, aluminum alloy.

11. The mandibular advancement device according to claim 6, wherein the outer wall forms an angle of 20-150 ° with the horizontal plane.

12. A mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

The upper bracket and the lower bracket are provided with bottom walls;

wherein the bottom wall comprises at least in part the second material.

13. The mandibular advancement device according to claim 12, wherein the bottom wall comprises only the second material.

14. The mandibular advancement device according to claim 12, wherein the thickness of the second material in the bottom wall is at least 0.3mm.

15. The mandibular advancement device according to claim 12, wherein the projected area of the bottom wall on the horizontal plane is at least 9cm ².

16. The mandibular advancement device according to claim 12, wherein the first and second materials are crimped, overmolded, snapped, glued, heat fused, screwed, hook-and-hold.

17. A mandibular advancement device for preventing or reducing snoring and/or obstructive sleep apnea during sleep, comprising:

The upper and lower brackets have one or more of the following characteristics:

The thickness of at least part of the outer wall ranges from 0.3mm to 6mm;

the bottom wall has at least a portion of a thickness in the range of 0.3-6mm.

18. The mandibular advancement device according to claim 17, wherein the height of the middle of the outer wall is greater than the height of the ends of the outer wall.

19. The mandibular advancement device according to claim 17, wherein the width of the outer wall is smaller in the middle than at both ends of the outer wall.

20. The mandibular advancement device according to claim 17, wherein the upper bracket includes a first outer wall and a second outer wall and the lower bracket includes a third outer wall and a fourth outer wall.

21. The mandibular advancement device according to claim 20, wherein the second outer wall comprises only the first material, the first outer wall comprising the second material.

22. The mandibular advancement device according to claim 20, wherein the third outer wall comprises only the first material and the fourth outer wall comprises the second material.