Apparatus for treating sleep apnea or other breathing disorders

Abstract

An apparatus for treating sleep apnea and other sleeping disorders, including snoring and bruxism, but also mouth cavity hygiene, and also possibly drug delivery is provided. The apparatus comprises a device configured to be installed on a user's teeth to maintain a relative position of the upper and lower jaws, and a holding material. The device comprises at least one back part, such as a first back part, a second back part and connecting portion (if two back parts are provided), the first back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the right side of a user's teeth when the user's teeth are in a substantially closed position, and the second back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the left side of the user's teeth when the user's teeth are in a substantially closed position, the connecting portion connecting the first and second back parts and configured to extend along the front teeth of the user's teeth. The holding material is included in or configured to be applied to the first and second back parts to secure contact of the teeth with the first and second back parts, respectively, by creating an adhesive effect, a vacuum effect, or a mechanical holding effect on the teeth in contact with the first and second back parts, respectively.

Description

[0001] 119654P1396PC-NA

[0002] APPARATUS FOR TREATING SLEEP APNEA OR OTHER BREATHING DISORDERS

[0003] BACKGROUND OF THE INVENTION

[0004] Technical Field

[0005] The present invention generally relates to the field of devices for sleep apnea or other sleep disorders, particularly breathing disorders. In particular, the present invention can provide an apparatus with a device that is easy to set up and use is compact in size, and may allow for increased comfort for a user wearing the device while sleeping. Specifically, the present invention provides an oral appliance for treating sleep apnea, snoring, bruxism, mouth cavity hygiene, and possibly drug delivery.

[0006] Art

[0007] Sleep apnea is a sleep disorder characterized by repeated pauses in breathing during sleep. These pauses can last from a few seconds to a couple of minutes and can occur multiple times throughout the night. Sleep apnea can be of different types. Obstructive Sleep Apnea (OSA) refers to the most common type, caused by a physical blockage or collapse of the airway during sleep, leading to interrupted breathing. The most common symptoms of sleep apnea include loud snoring, abrupt awakenings accompanied by choking or gasping, excessive daytime sleepiness, morning headaches, and difficulty concentrating. This may also cause breathing through the open mouth, which may in turn cause dry mouth and bad breath. Apart from that, open-mouth breathing has an effect on the pH value in the mouth, which may cause damage to the tooth enamel and increase the potential for cavities.

[0008] Treatment options for sleep apnea depend on the severity and type of sleep apnea. First of all, a user may make certain lifestyle modifications that can help alleviate mild cases of sleep apnea. This includes maintaining a healthy weight, regular exercise, avoiding alcohol and sedatives, and sleeping on your side instead of your back. A common treatment for moderate to severe obstructive sleep apnea is Continuous Positive Airway Pressure (CPAP). A CPAP machine delivers a constant stream of air through a mask, which keeps the airway open during sleep. There are also known oral appliances. For instance, certain dental devices can be worn during sleep to reposition the jaw and tongue, helping to keep the airway open. Another treatment is Bi-level Positive Airway Pressure (BiPAP). This machine delivers different pressures for inhalation and exhalation. It can be an option for individuals who have trouble tolerating CPAP. In some cases, surgery may be recommended to remove excess tissue, correct structural abnormalities, or implant devices to help keep the airway open. 119654P1396PC-NA

[0009] CPAP masks are an integral part of the CPAP therapy used to treat obstructive sleep apnea. These masks deliver a continuous flow of pressurized air to keep the airway open during sleep, preventing pauses in breathing. There are several types of CPAP masks available to suit individual preferences and needs. Nasal masks cover the nose and are held in place with straps. They are the most common type of CPAP mask and are suitable for people who breathe through their nose during sleep. Full face masks cover both the nose and mouth. They are suitable for people who breathe through their mouth or have difficulty breathing through their nose.

[0010] CPAP masks require a proper fit to maintain an effective seal and prevents air leaks. Most masks have adjustable straps and cushioning for personalized adjustment and comfort. It may take some time to find the right mask and make necessary adjustments to achieve a comfortable fit. Regular cleaning and maintenance of CPAP masks are necessary to ensure hygiene and prolong their lifespan. Overall, CPAP masks tend to be bulky, may be inconvenient in use and may affect the user’s sleep, e.g., because a tube connection to the CPAP machine may restrict movements of the user.

[0011] Devices that secure the lips or jaws of a user to prevent pauses in breathing during sleep are typically referred to as oral appliances. These devices are used as an alternative treatment option for certain individuals with obstructive sleep apnea (OSA) who are unable to tolerate or prefer not to use a CPAP machine. Oral appliances work by repositioning the jaw, tongue, and / or other oral structures to help maintain an open airway during sleep. By advancing the lower jaw (mandible) slightly forward, the oral appliance helps to prevent the collapse or obstruction of the airway that leads to breathing pauses. Such mandibular advancement devices (MADs) may resemble mouth guards or dental retainers. They consist of separate upper and lower splints that fit over the teeth and are connected by hinges. The lower splint is adjusted to hold the jaw in a forward position, thus opening the airway. Typically, a dentist will assess the user's dental and oral health, take impressions or digital scans of the teeth, and design a custom-fitted oral appliance, which may be a hurdle for the user and may lead to high costs for the device. There are also devices which use a “boil-and-bite” concept. Such devices are made of a thermoplastic material that is heated, e.g., in warm water, causing it to soften and adapt to the user's teeth when bitten to cause a suction effect.

[0012] There are also devices available that hold the lips of a user closed together. Such devices resemble an adhesive tape that is placed over the mouth. While a little hole may allow breathing through the mouth, such devices may cause discomfort. Apart from that, they are less effective for preventing collapse or obstruction of the airway because keeping the lips 119654P1396PC-NA closed generally has hardly any effect on the actual position of the jaws, particularly with regards to mandibular advancement.

[0013] SUMMARY OF THE INVENTION

[0014] It is an object of the present invention to provide an improved device for treating sleep apnea. Specifically, an improved device shall be provided that effectively can prevent collapse or obstruction of a user’s airway during sleep, which may cause sleep apnea, including other possible sleep disorders. The device shall be designed to be easily set up and used by the user and to be compact in size to reduce discomfort for the user during sleep when wearing the device.

[0015] A solution to this problem is provided by the teaching of independent claims. Various preferred embodiments of the present invention are provided by the teachings of the dependent claims.

[0016] According to one aspect, an apparatus for treating sleep apnea is provided. The apparatus comprises a device configured to be installed on a user’s teeth to maintain a relative position of the upper and lower jaws, and a holding material.

[0017] The device comprises at least one back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the right side or the left side of a user’s teeth when the user’s teeth are in a substantially closed position. The holding material is included in or configured to be applied to the at least one back part to secure contact of the teeth with the back part by creating an adhesive effect, a vacuum effect, or a mechanical holding effect on the teeth in contact with back part.

[0018] The apparatus of the present invention, thus, provides an improved oral appliance for treating sleep apnea, particularly sleep apnea, specifically obstructive sleep apnea (OSA), that is able to maintain the upper and lower jaws of the user in a relative position, more specifically a relative closed position to keep the airway open. The relative position may be particularly a fixed position. However, it will be appreciated that the “fixed position” is not necessarily a totally fixed position but may allow movement to a certain extent within certain limits which does not affect effectiveness of the sleep apnea treatment, i.e. , as long as it is ensured that the jaws are maintained in such a position that prevents obstruction of the airway. Thus, the “fixed position” may also be referred to as “relative position” and vice versa. Specifically, in some cases, the device may be able to maintain a fixed (or relative) position of the jaws where the lower jaw is prevented from falling in a backward position (relative to a natural position). The 119654P1396PC-NA device may generally also be referred to as “oral device” or “intra-oral device” and provides a treatment device for open airway therapy (OAT). Keeping the upper and lower jaws in a fixed position and, thus, substantially closed together, also can prevent the tongue from falling backwards (which would cause obstruction of the airway).

[0019] Specifically, in some cases, the device may be able to maintain a fixed position of the jaws where the lower jaw is in a slightly forward position (relative to a natural position). Thereby, the device may also be referred to as a mandibular advancement device (MAD). Such position of the jaws specifically may tighten and thereby prevent over-relaxation of the soft tissue and muscles of the upper airway (including the so-called soft palate) which may lead to obstruction of the airway thereby causing pauses in breathing or shallow breaths during sleep. The device may also be suitable to treat snoring because the tightening created by the device also prevents the tissues of the upper airway from vibrating as air passes over them, which is the most common cause of snoring.

[0020] The holding material, which may also be referred to as “bonding material”, “forming material” or “fitting material”, further promotes maintaining the relative position between the upper and lower jaws. As will be described in more detail below it may already be included in the device, particularly the at least one back part (or specifically the first and second back parts; see below) or may be applied thereto or inserted therein once the user wishes to use the device. The holding material secures the teeth to the device. Specifically, once the user bites gently on the device in the desired relative position of the upper and lower jaws and brings the teeth in contact with the device, the holding material will create an adhesive effect (i.e. , gluing the teeth together through molecular interaction) or mechanical holding effect, such as a suction effect that effectively holds the teeth together in place on the device during sleep. Specifically, the holding material may form a vacuum force that keeps the upper and lower jaws closed. Particularly in this case it may be provided in the form of a forming material that conforms to the patient's teeth to create the vacuum effect.

[0021] This is a very convenient way for the user to fix the device in place. Apart from that, the holding material will automatically adapt to any shape of the teeth of any user such there is no need to provide a customized device. This may be achieved by providing the holding material in the form of a soft and formable material, such as a gel, paste, fluid, foam, or the like as will be described in more detail below.

[0022] The device can be easily set up and secured in the user’s mouth (more specifically to the teeth). Thus, the device can fit various sets of teeth without the need of custom fitting it for a 119654P1396PC-NA specific user. Finally, this provides a device at relatively low costs. The device is convenient to wear because the lips of the user are free such that breathing through the mouth is still possible.

[0023] The apparatus of the present invention also provides an improved device for treating mouth breathing, snoring, or other breathing disorders for the same reasons. Thus, for the sake of simplicity all are referred to as “sleep apnea” throughout this document. This means that the term “sleep apnea” shall not only refer to “sleep apnea” but also to other sleep disorders, such as mouth breathing, snoring, or other breathing disorders. The apparatus may also be used for treating dental sleep disorders, particularly bruxism.

[0024] The terms “front” and “back” are used for distinguishing the portions of the device, in particular relative to a user’s mouth when worn. Thus, it will be appreciated that the position and orientation may vary when the device is not worn by a user or when the user moves. The upper jaw is also referred to as maxilla, while the lower jaw is also referred to as mandible.

[0025] The terms “first”, “second”, “third” and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

[0026] Where the term “comprising” or “including” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun e.g., “a” or “an”, “the”, this includes a plural of that noun unless something else is specifically stated.

[0027] Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0028] In the following, preferred embodiments of the device are described, which can be arbitrarily combined with each other or with other aspects of the present invention, unless such combination is explicitly excluded or technically impossible.

[0029] In some embodiments, the at least one back part comprises a first back part, a second back part and connecting portion, the first back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, 119654P1396PC-NA respectively, of the right side of a user’s teeth when the user’s teeth are in a substantially closed position, and the second back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the left side of the user’s teeth when the user’s teeth are in a substantially closed position. The device may further comprise a connecting portion connecting the first and second back parts and configured to extend along the front teeth of the user’s teeth. The holding material is included in or configured to be applied to the first and second back parts to secure contact of the teeth with the first and second back parts, respectively, by creating an adhesive effect, a vacuum force, or a mechanical holding effect on the teeth in contact with the first and second back parts, respectively. Providing back parts one both sides of the teeth may improve maintenance of the relative position of the upper and lower jaws.

[0030] In some embodiments, the device further comprises a front part having an upper cavity for receiving upper front teeth and a lower cavity for receiving lower front teeth, wherein the lower cavity is offset in a forward direction with respect to the upper cavity within the front part such that the lower jaw is brought in an advanced position relative to the upper jaw. The front part provides additional support for maintaining the relative (fixed) position of the upper and lower jaws. Specifically, the front teeth of the upper and lower jaws can be received in the front part, thereby forcing the upper and lower jaws into a relative position where the lower jaw is in an advanced position relative to the upper jaw. The device may then explicitly be used as a mandibular advancement device (MAD), which is particularly useful for treating sleeping disorders as described above.

[0031] In some alternative embodiments, the device further comprises a front part configured to be received between upper front teeth and lower front teeth to provide an offset in a forward direction of the lower front teeth relative to the upper front teeth such that the lower jaw is brought in an advanced position relative to the upper jaw. Specifically, the front part may be configured to be received between the “outer” (labial) surfaces of the upper front teeth and the “inner” (lingual) surfaces of the lower front teeth, thereby forcing the upper and lower jaws into a relative position where the lower jaw is in an advanced position relative to the upper jaw. This design of the front part may also provide additional support for maintaining the relative (fixed) position of the upper and lower jaws but in a different way. It does not receive the front teeth as the previously described design of the front part but may be provided in the form of a block, balloon, or the like. It may also be possible to make this type of front part removable. In other words, after the relative position of the upper and lower jaws is secured by means of the holding material, the front part could be removed. This can make the device more convenient to wear. 119654P1396PC-NA

[0032] In some related embodiments, a dimension of the front part that defines the offset of the lower teeth relative to the upper teeth in the forward direction is fixed or adjustable. If it is fixed, it may be provided in a set of various offset sizes, e.g., in the range from 1 mm to 5 mm. The user may then choose the size that fits their need the best. If the offset dimension is adjustable, this can be achieved, e.g., by a rotating mechanism or pumping mechanism. In a rotating mechanism, the user may rotate, e.g., a screw-like or screwdriver-like operating device at the front of the front part until a desired amount of offset is achieved. This rotating mechanism could then be removed. In a pumping mechanism, e.g., a balloon-like or harmonica-like front part may be pumped until the desired offset is achieved.

[0033] In some embodiments, the front part is arranged in the center of the connecting portion between the first and second back parts such that a first section of the connecting portion connects the front part to the first back part and a first section of the connecting portion connects the front part to the second back part. In other words, the connecting portion may be interrupted by the front part to form two sections, each of which connects the front part to the respective back part. In other designs, in particular where the front part is removable, the connecting portion may continuously extend between the first and second back parts along the front teeth.

[0034] In some embodiments, the first and second back parts are formed as bite pads (which may also be referred to as “(dental) splints” herein). Speaking in more general terms, while splints are typically configured to extend around the teeth on both opposite sides (i.e., vestibular (labial I buccal) and oral (palatal I lingual)), devices of such alternative embodiments may engage only one of the sides of the teeth. Specifically, the user will “bite on” the upper and lower sides of the bite pads. It will be appreciated that the term or “pad” does not necessarily mean to have a totally flat shape but may comprise a curvature suitable to adapt one or more teeth. In particular, the pad-like element may be flexible such it adapts to the dental arches of the upper and lower jaws. Further, also a “bite pad” may be provided with side edges, in particular such that the holding material will be kept thereon without flowing outwards to the sides.

[0035] In some embodiments, at least a portion of the at least one back part, specifically the first and second back parts between the respective upper and lower sides thereof has at least one hole, preferably a plurality of holes or is at least partially formed as a mesh-like structure to facilitate distribution of the holding material in back part(s) between the respective upper and lower sides thereof. While it is possible to apply the holding material separately on the upper and lower sides of the first and second back parts, application of the holding material is facilitated if it can penetrate through the back part(s) from the upper to the lower side (and vice versa). 119654P1396PC-NA

[0036] Application of the holding material can then be done only from one side as it will automatically distribute through the holes or mesh-like structure to the other side.

[0037] In some embodiments, the holding material is provided as a two-component material containing a first component and a second component, wherein the holding material is configured to cure at least partially after the first and second components are mixed. The two components may cure, e.g., by means of a chemical reaction after a couple of minutes. In this period of time, after the holding material has been mixed and applied to the device, the user has time to insert the device into the mouth and place it onto the teeth. The upper and lower jaws may be brought in the desired relative position as described above. The holding material then cures and securely holds the teeth on the device. Alternatively, the holding material may be provided as a one-component material that cures at least partially when it comes into contact with air or saliva, thereby achieving the same effect.

[0038] In some embodiments, the holding material, particularly the aforementioned two-component holding material, is provided in a cartridge having a first compartment filled with the first component and a second compartment filled with the second compartment, a mixing mechanism, and a dispensing mechanism, the mixing mechanism having a first inlet from the first compartment, a second inlet from the second compartment and an outlet to the dispensing mechanism, wherein the dispensing mechanism has at least one outlet, such as first and second outlets to dispense the mixed holding material to the at least one back part, specifically the first and second back parts, respectively. The mixing mechanism may be motor driven, such that the user can activate the process, e.g., by pushing a button. A desired or predefined amount of holding material can then be applied to the device, in particular the first and second back parts. This can be done manually, e.g., by holding the device beneath the dispensing outlets. Alternatively, the cartridge may include a further compartment for one or more devices. In particular, a prefilled cartridge can be provided that has device for several days, such as a week or a month stored therein, such that the holding material can be automatically applied to one of the devices, which can then be taken by the user from the cartridge ready for use.

[0039] In some embodiments, the apparatus further comprises an insertion device for inserting the device into the user’s mouth and installing the device on the user’s teeth, wherein the insertion device is configured to be releasably attached to the device. Provision of an insertion device can facilitate insertion of the device into the user’s mouth, in particular if the device is made from a soft and pliable material, such as silicone material (see below). The device may then be kind of “floppy”, which on the hand makes the device more convenient to wear, but on the other and more difficult to handle. The insertion device can be releasably attached to the device 119654P1396PC-NA for insertion and can then be detached from the device once the device is in place. The insertion device can then be used another day for another device again.

[0040] In some embodiments, the device is formed from a flexible (i.e., soft and pliable) material, such as rubber, silicone, or the like. It will be appreciated that the material is preferably a medical grade suitable material for use in the mouth. Any of the here described embodiments may be at least partially, or even completely disposable. This means that the device may be configured for single use, i.e., for one night.

[0041] In some related embodiments, the insertion device is substantially arc shaped having a first section with a first engagement mechanism configured to be releasably attached to the first back part, a second section with a second engagement mechanism configured to be releasably attached to the second back part and a middle section between the first and second sections, wherein the middle section is configured as a handle to be grasped by the user for inserting the device the user’s mouth. The arc shape may resemble the arc shape of a user’s teeth and thus the device. The first and second engagement mechanisms may be, e.g., pins or magnets that releasably attach to the first and second back parts, respectively. It will be appreciated that the device then will have the respective engagement mechanism counterpart, such as a cavity or opening for receiving the pin of the insertion device or a respective magnet. The middle section of the arc may have a handle so that the user can hold the insertion device with the device attached thereto for insertion into the mouth.

[0042] In some related embodiments, the middle section has a third engagement mechanism configured to be releasably attached to the front part. Specifically in cases where the device has a front part it is advantageous to also provide a third engagement mechanism that releasably attaches to the front part. The third engagement mechanism may be configured, e.g., like the first and second engagement mechanism as pins or magnets and / or as a recess that is sized and shaped to receive the front part.

[0043] In some related embodiments, the insertion device is configured to deliver the holding material to the first and second back parts, wherein the middle section comprises at least one compartment filled with the holding material connected to the first and second engagement mechanisms, each of which comprises an outlet for inserting the holding material into the first and second back parts, respectively. More specifically, if the holding material is a two- component material, the middle section may have two compartments. The two components may then be mixed upon insertion of the device in the insertion device by squeezing the handle. The two components may then be mixed and delivered through the insertion device towards 119654P1396PC-NA the first and second sections, which may have respective outlets such that the holding material can be applied to the first and second back parts, respectively.

[0044] In some embodiments, the device further comprises at least one sensor for measuring at least one body parameter in the user’s mouth. In this way, the device is not only suitable for open airway therapy but also for monitoring body parameters that may occur in the context of sleep apnea. It will be appreciated that the device may include an internal or external battery for supplying the sensor(s) with electric energy, The parameters may comprise at least one of temperature, oxygen level, pH-value, breathing pattern, and snoring and many more as will be described below.

[0045] The pH-value of the saliva may be an indicator for mouth breathing as the pH-value will slightly increase (typically from slightly acidic to slightly basic) when the user breathes through the mouth. The oxygen level (e.g., measured by any oximetry optical sensor) may drop when the user experiences an episode of sleep apnea. A pulse rate sensor may detect spikes in the pulse, which may occur after the body has experienced an episode of sleep apnea and tries to start breathing again. Sensors, in particular pressure sensors for detecting breathing movement, effort and / or patterns may also be used in detecting sleep apnea. Peripheral arterial tonometry sensors may provide an indication if the body is experiencing and acute stress response by measuring elevations in arterial tone. Sensors may be provided for photoplethysmography (PPG) to monitor the heart rate by optical measuring volumetric variations of blood circulation. In particular with PPG-sensors, multiple sensors may be applied (see below) and the travel time between the sensors may be evaluated.

[0046] It may also be valuable information to monitor the user’s body position (e.g., if the user is sleep on the back, on the sides or on the stomach) by appropriate positioning sensors during sleeping, which may help in giving sleeping advice to avoid sleep apnea. Another valuable information may be to monitor sleep phases, such as light sleep and deep sleep phases. Acoustic sensors may also be envisioned.

[0047] Measurement data can be stored and read out by another device, such as a mobile device, e.g., smartphone, a distinct reading device, or other user device, or can be directly sent to another (external) device. Reading or sending may use a wired or wireless connection, such as Bluetooth or NFC. The sensor(s) may be provided in the form of integrated circuits (“chips”) attached to the device. It will be appreciated that data collected by the sensor(s) may be evaluated using machine learning (artificial intelligence (Al)) techniques. 119654P1396PC-NA

[0048] In some embodiments, the first and second back parts and the front part each comprise at least one sensor device, wherein the sensor devices in the first and second back parts and the front part are configured to measure the same body parameters or different body parameters. Thereby, the sensor(s) can be positioned at appropriate positions between the upper and lower jaws, e.g., in front of the front teeth in direct contact with the cheeks, the gum, or the tongue which promotes measurement of several biometric signals. This may improve the measurement results, particularly with regard to the oxygen, temperature, pH-value, breathing frequency, and other biometrics. However, it may also be envisioned to provide all parts of the device with the same sensors. As already mentioned above, although only a short distance lies between the sensors, the measured values may slightly vary (e.g., PPG-sensor values), which may provide further valuable information.

[0049] According to another aspect, a set may be provided, comprising a plurality of apparatuses for treating sleep apnea as described above, wherein at least one of the devices may have a sensor as explained above. This may be particularly advantageous if the devices are configured as single-use (disposable) devices. For instance, a set may comprise devices for several days or weeks, e.g., one week or one month, wherein only some of the devices may be provided with a sensor, e.g., one per week, five per month or the like. On the one hand, this may save costs. On the other hand, it may be sufficient to measure the aforementioned body parameters only once a week (i.e., only one night per week). It may also be envisioned to provide the sensor separately, and to attach it to a device, such that measurements can be made as often as needed.

[0050] It will be appreciated that explanations, embodiments, and advantages described above in connection with one aspect may similarly apply to any other aspect of the invention.

[0051] BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Illustrative embodiments are described below with reference to the drawings. In the interest of clarity, not all features of an actual implementation may be described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions might be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. In the drawings: 119654P1396PC-NA

[0053] Figs. 1a to 1f show different views of an embodiment of a device for treating sleep apnea comprising back parts and a front part;

[0054] Figs. 2a to 2c show different views of another embodiment of a device for treating sleep apnea comprising back parts and a front part similar to that of Fig. 1 but also with an insertion device;

[0055] Figs. 3a and 3b show embodiments of an insertion device;

[0056] Figs. 4a and 4b show different views of another embodiment of a device for treating sleep apnea comprising back parts and a front part similar to that of Fig. 1 but also with another insertion device;

[0057] Figs. 5a to 5c show different views of another embodiment of a device for treating sleep apnea comprising back parts and an adjustable front part;

[0058] Figs. 6a and 6b show different views of another embodiment of a device for treating sleep apnea comprising back parts and an adjustable front part;

[0059] Fig. 7 shows another embodiment of a device for treating sleep apnea comprising back parts and a dissolvable front part;

[0060] Figs. 8a and 8b show different views of another embodiment of a device for treating sleep apnea comprising back parts with holding material included;

[0061] Figs. 9a to 9c show different views of an embodiment of a cartridge prefilled with a plurality of devices for treating sleep apnea and a two-component holding material for automatic application of the holding material;

[0062] Figs. 10a and 10b show different views of another embodiment of a cartridge prefilled a two- component holding material for application of the holding material to a device;

[0063] Figs. 11 a to 11 c show different view of a mixing mechanism with a cleaning mechanism for the mixing mechanism;

[0064] Figs. 12a to 12g show different views of an embodiment of a splint for a device for treating sleep apnea with the application of a two-component holding material;

[0065] Figs. 13a and 13b show different views of a device for treating sleep apnea with back parts with a mesh-like structure;

[0066] Fig. 14 shows another embodiment of a device for treating sleep apnea with bite pads; 119654P1396PC-NA

[0067] Fig. 15 shows another embodiment of a device for treating sleep apnea with a pull band;

[0068] Figs. 16a to 16e show splints for a device for treating sleep apnea with adhesive layers;

[0069] Fig. 17 shows a splint for a device for treating sleep apnea with adhesive coating;

[0070] Fig. 18 shows another embodiment of a device for treating sleep apnea comprising inflatable parts;

[0071] Figs. 19a and 19b show another embodiment of a device for treating sleep apnea comprising an inflatable balloon;

[0072] Figs. 20a and 20b show different views of another embodiment of a device for treating sleep apnea with a micro-suction surface;

[0073] Fig. 21 shows another embodiment of a device for treating sleep apnea with foldable pads; and

[0074] Figs. 22a and 22b show different views of a sensor component for a device for treating sleep apnea.

[0075] DESCRIPTION OF EMBODIMENTS

[0076] The drawings show various embodiments of an apparatus and / or a device for treating sleep apnea and / or further components of the apparatus. More specifically, the apparatus is configured for treating obstructive sleep apnea (OSA), which is caused by obstruction of the airway during sleep. The apparatus of the present invention aims at maintaining a fixed position (or “relative position”) of the upper and lower jaws of a user. That means, by fixing the jaws together in a specific alignment, the device may thereby help to prevent the collapse or obstruction of the airway that leads to breathing pauses.

[0077] While a fixed position of the jaws could be maintained in which the lower jaw (mandible) is held in a (slightly) forward position. This may enhance the effectiveness of the device. However, it will be appreciated that it is not necessary to advance the lower jaw to achieve the advantages of the present invention, but it is sufficient to maintain a fixed position of the upper and lower jaws to prevent the lower jaw from falling backwards (while possibly opening the mouth). 119654P1396PC-NA

[0078] Figs. 1a to 1f show various views of an embodiment of a device 100 for treating sleep apnea in the form of a mandibular advancement device. It will be appreciated that this device as well as all other devices described herein may also be used for treating other breathing disorders, e.g., for snoring cancellation. For the sake of simplicity, as also explained earlier in this document, all of them are referred to as “sleep apnea” in general.

[0079] The device 100 has two back parts 101 , 102, such as splints or bite pads that are configured to receive, e.g., the last back teeth of the upper and lower jaws, respectively, e.g., the last three teeth (or only one or two, or more, such as four), including at least one molar and / or premolar of the left and right sides of the patient’s teeth. The teeth are received on the respective upper and lower sides of the back parts 101 , 102. As shown in Fig. 1a, the bite pads 101 , 102 may have a receiving structure to improve hold on the teeth by suction. Alternatively, as shown in Fig. 1 b, there may be no structure. Fixation may be achieved, e.g., by a holding material (in particular two-component material) as will be described herein adhesive effect, a vacuum effect, or a mechanical holding effect on the teeth. For instance, the holding material may be provided as a forming material to create a suction (vacuum) force between the user's teeth and the back parts 101 , 102. It will be appreciated that in this (and other embodiments), the two back parts may have the same design or different designs. Furthermore, generally it will be appreciated that only one of the back parts 101 , 102 may be sufficient to achieve basically the same effect.

[0080] The device 100 has a front part 103 connected with a connecting portion 104, such as a band or the like, to receive the front teeth of the upper and lower jaws. The front part 103 is designed such that the lower jaw is advanced by about 3 mm as the lower teeth are kept in a forward position. For this purpose, the front part 103 has an upper cavity for receiving upper front teeth and a lower cavity for receiving lower front teeth, wherein the lower cavity is offset in a forward direction with respect to the upper cavity within the front part 103. The front part 103 has an opening 105 which is configured to receive a positioning device, such as a stick 106 or the like. The stick 106 is inserted through the opening at a certain angle to urge the lower teeth in the forwardly advanced position (Fig. 1 C) . The stick 106 can be pushed inward from its upper end to let the user achieve their desired jaw advancement. Once the device 100 is secured to the teeth, specifically by the holding material (that cures, e.g., after a couple of minutes), which means that the relative position of the upper and lower jaws is fixed, the stick 106 can be removed. In this (and other embodiments), a gel or the like may be applied to the front part for increasing comfort. 119654P1396PC-NA

[0081] The device 100 may comprise at least one sensor for measuring body parameters in the user’s mouth (not shown). Thus, the device 100 may also function as a device for monitoring the sleep of the user by measuring parameters in the mouth. For instance, the pH-value of the saliva may be an indicator for mouth breathing as the pH-value will slightly decrease (typically from slightly basic to slightly acidic) when the user breathes through the mouth. A rise of the pH-value may cause damage to the tooth enamel increasing the risk of cavities. The body parameters may comprise a temperature, an oxygen level, heart rate, or a pH-value (or various combinations thereof, including further parameters that may be measured in the mouth as described earlier). It may also be envisioned to detect a breathing pattern and / or snoring, which may be an indicator for the severity of the sleep apnea. This can be achieved, e.g., by detecting a breathing pressure. In the device 100, different sensors may be included in the back parts 101 , 102 and / or the front part 103. In this way, a preferred position for each sensor in the mouth can be chosen. It will be appreciated that all sensors in the back parts 101 , 102 and / or the front part 103 may alternatively the same sensors. Furthermore, it will be appreciated that any of the embodiments of a device for treating sleep apnea described herein may be provided with at least one sensor where appropriate. The device with sensors could be used to do a sleep apnea study in the comfort of the users’ homes instead of a clinic, where they have to sleep in the clinic.

[0082] Furthermore, for any embodiment described herein, a set may be provided, comprising a plurality of devices for treating sleep apnea, wherein at least one of the devices may have a sensor as explained above. This may be particularly advantageous if the devices are configured as single use (disposable) devices. For instance, a set may comprise devices for several days or weeks, e.g., one week or one month, wherein only some of the devices may be provided with a sensor, e.g., one per week, five per month or the like. On the one hand, this may save costs. On the other hand, it may be sufficient to measure the aforementioned body parameters only once a week (i.e., only one night per week). It may also be envisioned to provide the sensor separately, and to attach it to a device, such that measurements can be made as often as needed.

[0083] It will be appreciated that the obtained measurement data can be stored, read out, sent, and further processed, and analyzed as required, e.g., using Al, specifically on any suitable external device, such as a smartphone or dedicated reader device. Reading or sending may use a wired or wireless connection, such as Bluetooth or NFC.

[0084] Figs. 2a to 2c show different views of another embodiment of a device 200 for treating sleep apnea in the form of a mandibular advancement device comprising back parts 201 , 202 and a 119654P1396PC-NA front part 203 connection by a connecting portion 204 similar to that of Fig. 1. Therefore, it is referred to the description of Fig. 1. However, the connecting portion 204 is arranged to extend along the front teeth (with the front part 203 in between) on the outer side rather than the inner side as in the device 100 of Fig. 1. The device 200 also has openings 205 in the back parts 201 , 202 to receive respective engagement mechanisms (pins) of an insertion device 300, which will be described in more detail below with respective to Fig. 3. Fig. 2b shows a top view of the device 200 with the insertion device 300 attached thereto, while Fig. 2c shows a front view. The insertion device 300 can be releasably attached to the device 200 for facilitating insertion into the user’s mouth.

[0085] Figs. 3a shows a top view of the insertion device 300. It has an arc shape to match the shape of the device 200 as well as that of the user’s teeth. A first section 301 attaches to the first back part 201 of the device 200 by means of a pin 304 as an engagement mechanism to be received in the respective opening 205. A second section 302 attaches to the second back part 202 of the device 200 by means of a pin 305 as an engagement mechanism to be received in the respective opening 205. The first and second sections 301 , 302 may also act as a spring or snap-fit mechanism, keeping the device 200 firmly in place and preventing it from falling off. A middle section 303 is configured to attach to the front part 203, such as by a pin 306 of by a respective recess as shown in the top view of Fig. 3a. A handle 307 is provided in the middle section 303 that can be grasped by the user for insertion into the mouth. The insertion device 300 is attached to the device 200 before being placed in the mouth. The insertion device 300 is then detached from the device 200 as the user pulls the insertion device 300 out, and it can be easily removed from the mouth and the device 200 stays in place.

[0086] Referring now to Fig. 3b a cross-section view through an embodiment of the insertion device 300 is shown, which may also be used to deliver the holding material to the back parts 201 , 202 of the device 200. Two components of the holding material are provided in the handle 307 and initially separated by a separator 308. Once the user squeezes the handle 307, the two components mix in mixing channels 309 and are delivered to the back parts 201 , 202 via the pins 304, 305, which are provided with respective outlets.

[0087] Figs. 4a and 4b show different views of another embodiment of a device for treating sleep apnea in the form of a mandibular advancement device comprising back parts and a front part similar to that of Fig. 1 but also with another insertion device 400. The insertion device 400 attaches to the device using magnets 401 on the sides. Once correctly positioned in the mouth, the user can easily detach the magnet and remove the insertion device 400. The insertion device 400 sits underneath the arc connecting the front and back parts, providing support and 119654P1396PC-NA maintaining its shape. At the same time, it remains slim enough to ensure user comfort. Additionally, the front part of the insertion device 400 may feature a pin that fits into the device, ensuring maximum safety and ease when placing it in the mouth.

[0088] Figs. 5a to 5c show different views of another embodiment of a device 500 for treating sleep apnea in the form of a mandibular advancement device comprising back parts 501 , 502, a front part 503 and a connecting portion 504. Holding material can be applied to the back parts 501 , 502 to secure the teeth thereon, similar to the previously described devices. In order to adjust the amount of mandibular advancement, the size of the front part 503 can be adjusted. Once the user has placed the device in the mouth (and before the holding material is cured), the front part can be adjusted with a screw mechanism 505 to a desired protrusion of the lower jaw relative to the upper jaw. Once the holding material has cured, the front part 503 can be removed. Specifically, this may be done by rotating the screw mechanism 505 in the reverse direction to safely remove the front part 503.

[0089] Figs. 6a and 6b show different views of another embodiment of a device 600 for treating sleep apnea in the form of a mandibular advancement device comprising back parts 601 (only one of which is visible in Fig. 6) and an adjustable front part 603 connected by a connecting portion 604, similar to that of Fig. 5. However, rather than adjusting the front part 603 by means of a screw mechanism, the front part 603 is provided as a ballon-type part that can be inflated by a pumping mechanism 605 to adjust the mandibular advancement. After the desired amount of mandibular advancement has been found, and the teeth are securely held at the back parts by means of the holding material, the front part 603 can be removed by deflating it and disengaging it from the connecting portion 604.

[0090] Fig. 7 shows another embodiment of a device 700 for treating sleep apnea comprising back parts 701 , 702, a front part 703 and a connecting portion 704 similar to the previously described embodiments. In this embodiment, the front part 703 is dissolvable and may have the shape of a block or the like. Once the device 700 is installed in the mouth, the front part 703 will begin to dissolve such that the back parts 701 , 703 are only connected by the connecting portion 704, while being securely held by means of the holding material. In this embodiment, but also in embodiments in which the front part is not dissolvable, the user may choose between various sizes for the front part, e.g., ranging from (+ or -) 1 mm to (+ or -) 5 mm, depending on the desired mandibular advancement.

[0091] Figs. 8a and 8b show different views of another embodiment of a device 800 for treating sleep apnea comprising back parts 801 , 802. The device 800 may be designed as a gum-like device. 119654P1396PC-NA

[0092] The back parts 802, 801 , connected by a connecting portion 804, are provided in the form of gum like products. They can be placed, e.g., on the last two molars. When the user bites on the gum it sticks to the teeth. The gum could also be filled with holding material, such that, when the user bites the holding material is squeezed out and the teeth are attached to the back parts 801 , 802, respectively. The device 800 could also be accompanied by a hard chassis to make it easier for the user to place it in its right position, after placement it can be removed.

[0093] Figs. 9a to 9c show different views of an embodiment of a cartridge 900 prefilled with a plurality of devices 901 for treating sleep apnea and a two-component holding material for automatic application of the holding material. Fig. 9a shows the closed cartridge 900 with a delivery window 902 in a front cover 903 for taking out a device 901 , which is the uppermost device of the stack of devices 901. The cartridge 900 may be prefilled and refilled with devices 901 and holding material, e.g., for several days, like one week or one month. The front cover 903 may have an indicator 910 for the remaining devices 901 , such as a transparent area or the like.

[0094] As shown in Figs. 9b and 9c (open cartridge 900 without the front cover 903), the cartridge 900 has a first compartment 904 for a first component of the holding material, a second compartment 905 for the second component of the holding material, a mixing mechanism 906 for mixing the two components of the holding material, and a dispensing mechanism 907 for applying the mixed holding material to the uppermost device of the devices 901. Once the user pushes a button 909, the mixing mechanism (driven by a motor 908) mixes the two components, and the correct amount of holding material will automatically be applied to the device 901 . The user can then take the device 901 with the holding material ready for use out of the output window 902. A spring mechanism or the like (not shown) will then push up the stack of devices 901 upwards so that the process can be repeated the next time. The user can see in the indicator 910 how many devices 901 remain. The compartments 904 and 905 may be replaceable as well as the compartment that accommodates the devices 901 .

[0095] Figs. 10a and 10b show different views of another embodiment of a cartridge 1000 (which may also be referred to as dispenser) prefilled with a two-component holding material for manual application of the holding material. The cartridge 1000 has a first compartment 1004 for a first component of the holding material, a second compartment 1005 for the second component of the holding material, a mixing mechanism 1006 for mixing the two components of the holding material, and a dispensing outlet 1007 for applying the mixed holding material to apply the mixed holding material to a device 1001 that can be positioned beneath the holding material dispenser 1000 to receive a certain amount of holding material each time it is activated. More 119654P1396PC-NA specifically, there are two dispensing outlets 1007 so that the holding material can be applied to each of the first and second back parts of the device 1001 . The dispensing process can be triggered either manually via a switch or automatically through a sensor. With each activation, a controlled quantity of holding material can be released onto the device 1001.

[0096] It will be appreciated the devices 901 and 1001 in Figs. 9 and 10 are shown as “generic” devices. While the cartridge 900 may require specifically designed devices that may be stacked and filled in the cartridge 900, the cartridge (dispenser) 1000 may be used with any embodiment of devices for treating sleep apnea described herein to apply the holding material thereon.

[0097] Figs. 11 a to 11 c show different view of a mixing mechanism 1100, here in the form of a screw conveyor, provided with a cleaning mechanism 1101 for cleaning the mixing mechanism 1100. This is advantageous because, if the mixing mechanism 1100 is left uncleaned, the holding material will cure on the mixing mechanism 1100 and clog it. After each use, the cleaning mechanism 1101 wipes out the excess on the blades of the mixing mechanism 1100. This may be done automatically to remove any unwanted residue of holding material in the mixing mechanism 1100.

[0098] Figs. 12a to 12g show different views of an embodiment of a splint 1201 for a device for treating sleep apnea. More specifically, the splint 1201 is designed to receive a two-component adhesive (or generally holding or fitting material). The two-component material is provided in a pouch-like reservoir 1202 with two chambers 1204, 1205 to keep the two components of the material separated. The reservoir 1202 has a mixer 1206 such that the two components of the material are mixed once the reservoir 1202 is squeezed. The mixed material is dispensed via an opening 1207 into the splint 1201 . The splint 1201 is hollow and has holes 1203 or a meshlike structure such that the mixed material can fill the splint 1201 in the upper portion as well as in the lower portion thereof. The teeth are placed in the mixed material and a secured once the material cures after a couple of minutes. It will be appreciated that the application of a two- component adhesive (holding material) may be applied to any embodiment described herein.

[0099] Figs. 13a and 13b show different views of a device 1300 for treating sleep apnea with back parts 1301 , 1302 connected by a connecting portion 1304. A mesh structure 1303 facilitates distribution of the holding material between the upper and lower sides of the back parts 1301 , 1302. 119654P1396PC-NA

[0100] It will be appreciated that the mesh structure (or more generally, at least one hole, preferably a plurality of holes between the upper and lower sides) may be applied to any embodiment of devices for treating sleep apnea described herein where appropriate. This will facilitate application of the holding material only from one of the upper and lower sides of the respective back parts.

[0101] Generally, it may be envisioned to integrate flavors into the holding material. The flavors may then be released as the user is using the device. The flavor can be e.g., mint, chocolate, fruits, chamomile, lavender, eucalyptus, herbs, etc. It may also be envisioned to include throat ache relief products or antiseptics to relief users from bad breath, including mouth refreshers. Also, the device can be designed to release nicotine to help smokers overcome smoking, similar to a nicotine patch action. Generally, the device (specifically the holding material) may be used to deliver one or more drugs to the user, which may be released immediately or slowly over a certain period of time. Also, if multiple drugs are provided, they may be provided at once or in succession.

[0102] Fig. 14 shows another embodiment of a device 1400 for treating sleep apnea in the form of a mandibular advancement device. The device 1400, specifically the first and second back parts, have an upper portion 1401 , a lower portion 1402, and a rail 1403 permitting a linear motion between the upper portion 1401 and the lower portion 1402. The rail 1403 permits advancement of the device 1400 to the comfort of the user. The upper and lower portions 1401 , 1402 are configured as “bite pads” that may be positioned on the last teeth (molars) of the upper jaw and lower jaw, respectively, e.g., the last three teeth, or more or less teeth and / or at least one premolar. They are connected by means of a connecting portion in the form of bands 1404, 1405. The lower band 1405 is configured to extend on the back of the lower teeth. The upper band 1404 is configured to be positioned on the front of the upper teeth thus giving the device 1400 maximum security without being bulky.

[0103] Fig. 15 shows another embodiment of a device 1500 for treating sleep apnea in the form of a mandibular advancement device. Upper and lower portions 1501 , 1502 for receiving and fitting to the last teeth, e.g., the last three teeth, are connected by a rail 1503 as a sliding mechanism similar as in the embodiment of Fig. 14. Two bands 2004 are provided that are connected by a locking piece 2005 (“buckle”). The bands 2004 connect to the lower portions 2002 and extend therefrom at an angle such that they extend over the upper teeth. By pulling or loosening the bands 2004 the user can adapt the lower jaw advancement. 119654P1396PC-NA

[0104] Figs. 16a to 16e show splints 1601 , 1602 for a device 1600 for treating sleep apnea with adhesive layers. A first component 1610 of a material is applied and covered by a separating layer 1611. Then, a second component 1612 of a material is applied and covered by another separating layer 1613. The separating layers 1611 , 1613 will dissolve by saliva once the user applies the device 1600 in the mouth or bites on it such that the components 1610, 1612 come into contact to be able to cure to adhere to the teeth. It will be appreciated that this can be applied to any embodiment where appropriate.

[0105] Fig. 17 shows a splint 1701 for a device for treating sleep apnea. A first component 1710 of an adhesive or fitting material is pre-set on the device. The device may be provided in a kit that also has a container with a second component of the material (which is the activator), e.g., as a liquid powder or paste. Once the second component is applied, the material cures.

[0106] Fig. 18 shows another embodiment of a device 1800 for treating sleep apnea comprising inflatable parts, or which can be entirely inflatable. The device 1800 comes with a small squeeze pump (not shown) such that users can inflate the device 1800 to fit their teeth. The manual squeeze pump can be inserted into ports 1801 , 1802.

[0107] Figs. 19a and 19b show another embodiment of a device 1900 for treating sleep apnea comprising an inflatable balloon 1901. The balloon 1901 can be inflated by means of a pump (not shown) that can be connected to a port 1902. When the balloon 1901 is inflated, it advances the lower jaw, thus creating a mandibular advancing device.

[0108] Figs. 20a and 20b show different views of another embodiment of a device 2000 for treating sleep apnea with a micro-suction surface. Similar to the other embodiments, two splints or pads 2001 , 2003 (i.e. , the first and second back parts) are provided that are connected to each other by a band 2003. The device 2000 is configured to be fixed to the teeth by using microsuction technology, integrated into the device’s body design, in a tape format or other format. The micro-suction cups 2004 have enough suction power to keep the jaw closed but allow the user to remove the device 2000 with enough pulling power and reinstall it as needed during one sleep cycle. Also, this technology may be combined with a boil-and-bite material. This allows the device to fit perfectly on the teeth area to give the micro suction tape (or material) superior holding strength. It will be appreciated that the micro-suction technology may be combined with other adhesive options.

[0109] Fig. 21 shows another embodiment of a device 2100 for treating sleep apnea. While the device 2100 can adhere to the teeth by any of the previous methods mentioned above, it has a specific clamp design. The splints (or “bite pads”) 2101 (i.e., the first and second back parts) have 119654P1396PC-NA foldable side portions 2102, 2103. When a user bites on the device 2100, the side portions 2102, 2103 will fold or “click” upwards to enclose the teeth to secure the device 2100 in place.

[0110] Figs. 22a and 22b show different views of a sensor component for a device 2200 for treating sleep apnea. A patch 2201 is attached to the device 2200 by means of a connecting wire or cable 2202. The patch 2201 can then be placed anywhere on the face and contains all electronic components. It will be appreciated that the electronic components could also be distributed between the in-mouth part of the device 2200, and the external part (i.e., the patch 2201), depending on the size and volume of the components and the need to be inside or outside the mouth. This configuration may be applied for any sleep apnea device with a sensor. A sensor can measure various parameters as described above. A device with a sensor can be provided in a kit (set) as also described above.

[0111] While above at least one exemplary embodiment of the present invention has been described, it has to be noted that a great number of variations thereto exists. Furthermore, it is appreciated that the described exemplary embodiments only illustrate non-limiting examples of how the present invention can be implemented and that it is not intended to limit the scope, the application, or the configuration of the herein-described apparatuses and methods. Rather, the preceding description will provide the person skilled in the art with constructions for implementing at least one exemplary embodiment of the invention, wherein it has to be understood that various changes of functionality and the arrangement of the elements of the exemplary embodiment can be made, without deviating from the subject-matter defined by the appended claims and their legal equivalents.

Claims

119654P1396PC-NACLAIMS1 . An apparatus for treating sleep apnea, the apparatus comprising a device configured to be installed on a user’s teeth to maintain a relative position of the upper and lower jaws, and a holding material. wherein the device comprises at least one back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the right side or the left side of a user’s teeth when the user’s teeth are in a substantially closed position, wherein the holding material is included in or configured to be applied to the at least one back part to secure contact of the teeth with the back part by creating an adhesive effect, a vacuum effect, or a mechanical holding effect on the teeth in contact with back part.

2. The apparatus of claim 1 , wherein the at least one back part comprises a first back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the right side of a user’s teeth when the user’s teeth are in a substantially closed position, and a second back part having an upper side and a lower side configured to contact at least one premolar and / or molar of the upper and lower jaws, respectively, of the left side of the user’s teeth when the user’s teeth are in a substantially closed position, wherein the device further comprises a connecting portion connecting the first and second back parts and configured to extend along the front teeth of the user’s teeth, and wherein the holding material is included in or configured to be applied to the first and second back parts to secure contact of the teeth with the first and second back parts, respectively, by creating an adhesive effect, a vacuum effect, or a mechanical holding effect on the teeth in contact with the first and second back parts, respectively.

3. The apparatus of claim 2, wherein the device further comprises a front part having an upper cavity for receiving upper front teeth and a lower cavity for receiving lower front teeth, wherein the lower cavity is offset in a forward direction with respect to the upper cavity within the front part such that the lower jaw is brought in an advanced position relative to the upper jaw.

4. The apparatus of claim 2, wherein the device further comprises a front part configured to be received between upper front teeth and lower front teeth to provide an offset in a119654P1396PC-NA forward direction of the lower front teeth relative to the upper front teeth such that the lower jaw is brought in an advanced position relative to the upper jaw.

5. The apparatus of claim 4, wherein a dimension of the front part that defines the offset of the lower teeth relative to the upper teeth in the forward direction is fixed or adjustable.

6. The apparatus of any one of claims 3 to 5, wherein the front part is arranged in the center of the connecting portion between the first and second back parts such that a first section of the connecting portion connects the front part to the first back part and a first section of the connecting portion connects the front part to the second back part.

7. The apparatus of any one of the preceding claims, wherein the at least one back part is formed as a bite pad.

8. The apparatus of any one of the preceding claims, wherein at least a portion of the at least one back part between the respective upper and lower sides thereof has at least one hole or is at least partially formed as a mesh-like structure to facilitate distribution of the holding material in the at least one back part between the respective upper and lower sides thereof.

9. The apparatus of any one of the preceding claims, wherein the holding material is provided as a two-component material containing a first component and a second component, wherein the holding material is configured to cure at least partially after the first and second components are mixed.

10. The apparatus of any one of the preceding claims, wherein the holding material is provided in a cartridge having a first compartment filled with the first component and a second compartment filled with the second compartment, a mixing mechanism, and a dispensing mechanism, the mixing mechanism having a first inlet from the first compartment, a second inlet from the second compartment and an outlet to the dispensing mechanism, wherein the dispensing mechanism has at least one outlet to dispense the mixed holding material to the at least one back part.

11. The apparatus of any one of the preceding claims, further comprising an insertion device for inserting the device into the user’s mouth and installing the device on the user’s teeth, wherein the insertion device is configured to be releasably attached to the device.119654P1396PC-NA12. The apparatus of claim 11 and any one of claims 2 to 6, wherein the insertion device is arc shaped having a first section with a first engagement mechanism configured to be releasably attached to the first back part, a second section with a second engagement mechanism configured to be releasably attached to the second back part and a middle section between the first and second sections, wherein the middle section is configured as a handle to be grasped by the user for inserting the device the user’s mouth.

13. The apparatus of claim 11 or 12 and any one of claims 3 to 6, wherein the middle section has a third engagement mechanism configured to be releasably attached to the front part.

14. The apparatus of any one of claims 11 to 13, wherein the insertion device is configured to deliver the holding material to the first and second back parts, wherein the middle section comprises at least one compartment filled with the holding material connected to the first and second engagement mechanisms, each of which comprises an outlet for inserting the holding material into the first and second back parts, respectively.

15. The apparatus of any one of the preceding claims, wherein the device further comprises at least one sensor for measuring at least one body parameter in the user’s mouth.

16. The apparatus of claim 14 and any one of claims 2 to 6, wherein the first and second back parts and the front part each comprise at least one sensor, wherein the sensor in the first and second back parts and the front part are configured to measure the same body parameters or different body parameters.

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