Device for treating sleep apnea or other respiratory disorders

Abstract

An apparatus (100) for treating sleep apnea or other respiratory disorders is provided. The apparatus (100) includes an upper portion (101), a lower portion (102), and a middle portion (103). The upper portion (101) is configured to be placed on at least one tooth of the patient's upper jaw, while the lower portion (102) is configured to be placed on at least one tooth of the patient's lower jaw. The middle portion (103) is configured to connect the upper portion (101) and the lower portion (102) together when the upper portion (101) and the lower portion (102) are placed on the teeth of the patient's upper and lower jaws to maintain a fixed position of the upper and lower jaws. The apparatus (100) also includes at least one fastening member, such as dental floss, a nickel-titanium alloy wire, an elastic band, or the like. The fastening member is configured to engage at least one interdental space of each of the upper and lower jaws to fasten the upper portion (101) and the lower portion (102) to the teeth of the upper and lower jaws, respectively. Thus, the apparatus of the present invention provides an improved oral appliance for treating sleep apnea, particularly obstructive sleep apnea, which is capable of maintaining the upper and lower jaws of the patient in a fixed position to keep the airway unobstructed.

Description

Technical Field

[0001] This invention generally relates to the field of devices for treating sleep apnea or other breathing disorders. In particular, the invention can provide a device for treating sleep apnea that is easy to install and use, compact in size, and allows for improved comfort for patients wearing the device during sleep. Specifically, the invention provides an oral appliance for treating sleep apnea. Background Technology

[0002] Sleep apnea is a sleep disorder characterized by recurrent pauses in breathing during sleep. These pauses can last from seconds to minutes and may occur multiple times throughout the night. There are several types of sleep apnea. Obstructive sleep apnea (OSA) is the most common type, caused by a physical blockage or collapse of the airway during sleep, leading to interruptions in breathing. The most common symptoms of sleep apnea include loud snoring, sudden awakenings with choking or gasping, excessive daytime sleepiness, morning headaches, and difficulty concentrating. This can also lead to breathing through the mouth, which can in turn cause dry mouth and bad breath. Furthermore, mouth breathing affects the pH level in the mouth, which can lead to damage to tooth enamel and increase the risk of cavities.

[0003] Treatment options for sleep apnea depend on the severity and type of sleep apnea. First, patients can make certain lifestyle changes that can help alleviate mild sleep apnea. These include maintaining a healthy weight, exercising regularly, avoiding alcohol and sedatives, and sleeping on their side instead of their back. A common treatment for moderate to severe obstructive sleep apnea is continuous positive airway pressure (CPAP). A CPAP machine delivers a continuous airflow through a mask, which keeps the airway open during sleep. Oral appliances are also known. For example, some dental appliances can be worn during sleep to reposition the jaw and tongue, helping to keep the airway open. Another treatment is bilevel positive airway pressure (BiPAP). This machine provides different pressures for inhalation and exhalation. BiPAP may be an option for patients who cannot tolerate CPAP. In some cases, surgery may be recommended to remove excess tissue, correct structural abnormalities, or implant devices to help keep the airway open.

[0004] CPAP masks are an essential component of CPAP therapy used to treat obstructive sleep apnea. These masks deliver a continuous flow of pressurized air to keep the airway open during sleep, thus preventing apnea. Several types of CPAP masks exist to suit individual preferences and needs. Nasal masks cover the nose and are secured in place with straps. Nasal masks 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. Full-face masks are suitable for people who have difficulty breathing through their mouth or nose.

[0005] CPAP masks need to fit properly to maintain an effective seal and prevent air leakage. For personalized adjustments and comfort, most masks have adjustable straps and padding. Finding the correct mask and making the necessary adjustments for a comfortable fit can take some time. Regular cleaning and maintenance of the CPAP mask are essential to ensure hygiene and extend its lifespan. In general, CPAP masks tend to be bulky, which can make them less convenient to use and may, for example, restrict patient movement and disrupt sleep due to tubing connections to the CPAP machine.

[0006] Devices that hold a patient's lips or jaw in place to prevent apnea during sleep are commonly known as oral appliances. These appliances serve as an alternative treatment option for some individuals with obstructive sleep apnea (OSA) who cannot tolerate or do not wish to use a CPAP machine. Oral appliances work by repositioning the jaw, tongue, and other oral structures to help keep the airway open during sleep. By slightly moving the lower jaw (mandibular protraction device) forward, oral appliances help prevent airway collapse or obstruction that can lead to apnea. This type of device is similar to a mouthguard or dental retainer. A MAD consists of separate upper and lower splints that fit over the teeth and are connected by hinges. Adjusting the lower splint holds the jaw in a forward position, thus opening the airway. Typically, a dentist will assess a patient's dental and oral health, obtain dental impressions or digital scans, and design a custom-fit oral appliance, which can be difficult for the patient and may result in high appliance costs.

[0007] There are also available devices that keep the patient's lips closed. These devices are similar to tape placed over the mouth. While the small opening allows breathing through the mouth, this device can cause discomfort. Furthermore, this device is less effective at preventing airway collapse or obstruction because keeping the lips closed generally has little effect on the actual position of the jaw, especially in terms of mandibular advancement. Summary of the Invention

[0008] The object of this invention is to provide an improved device for treating sleep apnea. Specifically, an improved sleep apnea device will be provided that can effectively prevent the patient's airway from collapsing or becoming obstructed during sleep. The device will be designed to be easy for the patient to install and use, and will be compact in size to reduce discomfort when the patient wears the device during sleep.

[0009] The solution to this problem is provided by the teachings of the independent claims. Various preferred embodiments of the invention are provided by the teachings of the dependent claims.

[0010] According to one aspect, a device for treating sleep apnea is provided. The device includes an upper portion, a lower portion, and a middle portion. The upper portion is configured to rest on at least one tooth of the patient's maxilla, while the lower portion is configured to rest on at least one tooth of the patient's mandible. The middle portion is configured to connect the upper and lower portions together when the upper and lower portions are resting on the teeth of the patient's maxilla and mandible to maintain a fixed position of the maxilla and mandible. The device also includes at least one fastening member configured to engage with at least one interdental space of each of the maxilla and mandible to secure the upper and lower portions to the teeth of the maxilla and mandible, respectively.

[0011] Therefore, the device of the present invention provides an improved oral appliance for treating sleep apnea (particularly obstructive sleep apnea (OSA)) that is able to hold the patient's upper and lower jaws in a fixed position to maintain an open airway. It will be understood that a "fixed position" is not necessarily a completely fixed position, but rather allows for a degree of movement within the characteristic limitations that do not affect the effectiveness of the treatment for sleep apnea (i.e., as long as the jaws are held in a position that prevents airway obstruction). Therefore, a "fixed position" can also be referred to as a "relative position." Specifically, in some cases, the device is able to hold the jaws in a fixed position, preventing the lower jaw from falling into a posterior position (relative to its natural position). The device can also generally be referred to as an "oral appliance" or "intraoral appliance" and provides a treatment device for open airway therapy (OAT). Holding the upper and lower jaws in a fixed position, thereby substantially closing the jaws together, also prevents the tongue from falling back (which would lead to airway obstruction).

[0012] The device of the present invention also provides an improved device for treating mouth breathing, snoring, or other breathing disorders caused by the same reasons. Therefore, for simplicity, it will be referred to as "sleep apnea" throughout this document. This means that the term "sleep apnea" will refer to "sleep apnea, mouth breathing, snoring, or other breathing disorders".

[0013] Specifically, in some cases, the device can hold the jaw in a fixed position where the mandible is slightly forward (relative to its natural position). Therefore, the device can also be called a mandibular advancement device (MAD). Specifically, this position of the jaw tightens to prevent excessive relaxation of the soft tissues and muscles of the upper airway (including the so-called soft palate), which can lead to airway obstruction, causing sleep apnea or shallow breathing during sleep. The device can also be used to treat snoring because the tightening produced by the device also prevents the tissues of the upper airway from vibrating as air flows through them, vibration being the most common cause of snoring.

[0014] The device can be easily installed and secured in the patient's mouth (more specifically, to a tooth) by inserting a fastening member into at least one interdental space. Therefore, the device can be adapted to various groups of teeth without the need for custom fitting for a specific patient. Finally, this provides the device at a relatively low cost. The device is easy to wear because the fastening member's design allows for a design that avoids excessive clamping of the teeth, which could cause discomfort. Furthermore, the patient's lips move freely, allowing for continued mouth breathing.

[0015] The terms “upper,” “lower,” and “middle” are used to distinguish the different parts of the device, particularly those relative to the patient’s mouth when worn. Therefore, it will be understood that the position and orientation can change when the device is not worn by the patient or when the patient moves. The upper jaw is also called the maxilla, and the lower jaw is also called the mandible.

[0016] The terms "first," "second," "third," etc., used in the specification and claims are used to distinguish similar elements and are not necessarily used to describe order or chronological sequence. It will be understood that such terms can be used interchangeably where appropriate, and that embodiments of the invention described herein can operate in other orders different from those described or shown herein.

[0017] In the use of the term "comprising" or "including" in this specification and claims, other elements or steps are not excluded. When an indefinite or definite article (e.g., "a," "the") is used to refer to a singular noun, this includes the plural form of that noun unless expressly stated otherwise.

[0018] Furthermore, unless otherwise expressly stated, "or" refers to inclusive or, not exclusive or. For example, condition A or B is satisfied by any of the following: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); and both A and B are true (or exist).

[0019] Preferred embodiments of the apparatus are described below. Unless explicitly excluded or technically impossible, these preferred embodiments may be combined with each other or with other aspects of the invention.

[0020] In some embodiments, the upper and lower portions each have at least one securing device for securing the fastening member to the upper and lower portions, respectively. The securing device may include at least one of an opening, a notch, a pin, and a hook for engaging with the fastening member. Holes may be provided through which the fastening member can pass (or has passed through these holes). One or more of the holes may extend (in the lateral direction) to allow the fastening member to be accommodated in the interdental spaces of teeth of different sizes. A ratchet mechanism or the like may be provided in the holes to allow securing the fastening member and also to tighten the fastening member.

[0021] In some embodiments, the fastening member comprises at least one piece of dental floss. The dental floss may be pre-loaded, particularly fixed in or secured by the aforementioned fastening device. This facilitates patient use and application of the device, as it eliminates the need to manually thread (or otherwise secure) the dental floss through the various parts of the device. The fastening member may be of various elongated types, such as wire, band, cable, etc., instead of dental floss. For example, the fastening member may comprise at least one nickel-titanium alloy wire or rubber band. In particular, the fastening member may be made of any suitable material, including plastic, rubber, or metal, i.e., made of materials not necessarily commonly used for (dental) dental floss (such as nylon, polyethylene, or PTFE). The fastening member may have any cross-sectional shape suitable for fitting into the interdental space, such as circular or rectangular. Alternatively (or additionally), the fastening member may comprise at least one staple or at least one pin that can pass through at least one interdental space, just like dental floss. Alternatively (or additionally), an adhesive material, such as dental adhesive, may also be used for fixation.

[0022] In some embodiments, the fastening member comprises one or more strands of dental floss, one or more floss loops, or a combination thereof. Furthermore, the fastening member may include at least one strand of dental floss for each of the upper and lower portions respectively, at least one strand of dental floss used together for both the upper and lower portions, or a combination thereof. In particular, the stranded dental floss or floss loop may be configured to extend through only one interdental space, or to extend through more than one interdental space. The presence of a strand of dental floss or a floss loop extending through the interdental spaces in the upper and lower jaws allows for additional fixation of the upper and lower jaws by tightening the floss.

[0023] In some embodiments, the upper and lower portions are formed as dental splints, each configured to accommodate teeth of the maxilla and mandible, respectively. Each splint may extend along a segment of the maxilla and mandible, i.e., may accommodate more than one tooth. This segment may include one or more anterior teeth (front teeth), one or more posterior teeth (back teeth), or both. The term "sleep apnea mouthguard" may be used for this device. The splint may have a generally V-shaped or U-shaped cross-sectional profile adapted to accommodate teeth or be located within one or more interdental spaces. The V-shaped or U-shaped geometry may also be configured to provide slight compressive forces on the teeth due to the material construction, thereby providing retention forces for holding the splint. Snapping or mechanical mechanisms may be provided, allowing the splint to snap onto the teeth. For example, the "legs" of the V-shaped or U-shaped profile may be in a wide configuration of surface closure ("Snap") toward the teeth (e.g., using a snapping mechanism known from so-called "Snap Sleeves"). This generates a clamping force that supports the splint's fixation to the teeth.

[0024] In some embodiments, a moderately detachable or moisture-activated biocompatible adhesive may be used to hold the splint in place or retain it on the teeth while allowing the user to easily remove it upon waking.

[0025] In some embodiments, the splint has a retaining structure on its inner side, which faces at least one tooth when the splint is placed on the tooth and the retaining structure engages with the surface of at least one tooth or at least one interdental space. The retaining structure may have at least one of one or more ridges, barbs, knots, pins, etc., arranged horizontally or vertically. In this way, the risk of the splint slipping off the tooth can be reduced, or in other words, the gripping and retention force of the splint on the tooth can be improved. Because the retaining structure can be flexible and adaptable to different patients' teeth, it is not necessary to customize the splint.

[0026] In alternative embodiments, the upper, lower, and middle portions together form a plate-like or pad-like element, without a splint. More generally, while splints are typically configured to extend around the teeth on opposite sides (i.e., vestibular (labial / buccal) and intraoral (palatal / lingual)), the device in this alternative embodiment may engage only one side of the teeth. For example, a plate-like or pad-like element may be positioned in the region of the upper and lower anterior teeth, secured to the teeth by means of dental floss to maintain a fixed position of the upper and lower jaws. It will be understood that the terms "plate" or "pad" do not necessarily mean having a completely flat shape, but may include curvature adapted to conform to one or more teeth. In particular, the plate-like or pad-like element may be flexible, thereby adapting to the dental arches of the upper and lower jaws. While dental floss may be sufficient to hold the device in place, the upper and lower portions may have engagement devices, such as suction cups or the like, configured to engage surfaces of at least one tooth.

[0027] In some embodiments, the upper portion, lower portion, and middle portion are formed as a single unit. This facilitates the use of the device because assembly is not required in the mouth. The one-piece design also prevents individual components from being lost.

[0028] In some embodiments, the intermediate portion includes at least one elongated connecting member connecting the upper and lower portions. For example, the upper and lower portions may be interconnected by a cable-like or strip-like element. The elongated connecting member may be flexible or semi-rigid to allow for some degree of movement of the upper and lower jaws, provided that the aforementioned function for treating sleep apnea is not negatively affected.

[0029] In some alternative embodiments, the upper and lower portions are formed as separate pieces, wherein the middle portion includes a first portion attached to the upper portion and a second portion attached to the lower portion, the first and second portions being separate from each other and each housing a magnet, such that the first and second portions can be magnetically attached to each other. In this way, a two-piece design of the device can be provided, wherein the upper and lower portions are fixed in a fixed position by magnets, thereby fixing the upper and lower jaws.

[0030] In some embodiments, the device further includes a locking member configured to engage with the intermediate portion or a fastening member to secure the upper and lower jaws in a fixed position. For example, the locking member may be a plate-like element. This plate-like element may be provided with openings or other receiving structures to engage with the intermediate portion, thereby tightening the device. For example, the intermediate portion may include a cable (see above) passing through the locking member, which can be pulled to tighten.

[0031] In some embodiments, the fastening member (e.g., dental floss) has an anchoring mechanism for anchoring in the interdental space. The anchoring mechanism may include one or more anchoring elements arranged along the length of the fastening member or at its end, and may include a ball or spherical protrusion (or other type of groove) or barb or hook. The anchoring mechanism improves the fixation of the fastening member in the interdental space by preventing it from slipping out. Fastening members with anchoring mechanisms can also be used to pull the device toward the teeth. The anchoring mechanism may also be configured to expand upon contact with saliva. For example, expandable dental floss can be used, which can improve its fixation in the interdental space.

[0032] In some embodiments, the device further includes a tongue-fixing portion attached to or capable of being attached to at least one of the upper or lower portions, the tongue-fixing portion being configured to rest on at least a portion of the patient's tongue to fix the tongue and prevent the tongue from moving toward the patient's throat. This can further improve the treatment of sleep apnea. For example, the tongue-fixing portion can be attached to the tongue by suction, wherein the tongue-fixing portion can be configured in the form of a suction cup that can be placed on the tip of the tongue. To hold the tongue in a forward position, the tongue-fixing portion can be attached to the upper and / or lower portions by means of magnets. Thus, the tongue is fixed in place, but can also be easily released if needed.

[0033] In some embodiments, the upper and lower portions are made of a flexible material, such as rubber, silicone, etc. It will be understood that the material is preferably a medical-grade material suitable for oral use. Any embodiment described herein may be at least partially or even entirely disposable. This means that the device can be configured for single use, i.e., overnight use.

[0034] In some embodiments, the device further includes at least one sensor for measuring at least one parameter in the patient's mouth. In this way, the device is suitable not only for open airway therapy but also for monitoring (physical) parameters that may occur in the context of sleep apnea. Parameters may include at least one of temperature, oxygen concentration, pH, breathing pattern, and snoring. The pH of saliva can be an indicator of mouth breathing, as the pH level rises slightly (typically from slightly acidic to slightly alkaline) when a patient breathes through their mouth. Measurement data can be stored and read by other devices, such as mobile devices (e.g., smartphones, dedicated reading devices, or other user devices), or can be transmitted directly to another device. Reading or transmission can be performed using wired or wireless connections, such as Bluetooth or NFC. The sensor may be positioned in the central portion (or a locking portion, if applicable). Thus, the sensor can be positioned between the upper and lower jaws, for example, in front of the anterior teeth, in direct contact with the cheek, gums, or tongue, which facilitates the measurement of several biometric signals. This can improve measurement results, particularly regarding oxygen, temperature, pH, respiratory rate, and other biometrics.

[0035] According to another approach, a kit can be provided comprising multiple devices for treating sleep apnea as described above, wherein at least one of these devices may have a sensor as described above. This may be particularly advantageous when the devices are configured for single-use (disposable) applications. For example, the kit may comprise devices for use for several days or weeks (e.g., a week or a month), wherein only some of the devices may be equipped with sensors, e.g., one per week, five per month, etc. On the one hand, this can save costs. On the other hand, it may be sufficient to measure the aforementioned physical parameters once a week (i.e., only one night per week). It is also conceivable to set up the sensors separately and attach them to the devices so that measurements can be taken at the desired frequency.

[0036] It will be understood that the explanations, embodiments, and advantages described above in conjunction with one aspect can be similarly applied to any other aspect of the invention. Attached Figure Description

[0037] Exemplary embodiments will now be described with reference to the accompanying drawings. For clarity, this specification does not describe all features of the actual implementation. It will be understood, of course, that in the development of any such actual embodiment, many implementation-specific decisions may be made to achieve the developer's specific goals, such as complying with system-related and business-related constraints, which may differ between implementations. In the drawings:

[0038] Figures 1a to 1d Different views of an embodiment of a device for treating sleep apnea are shown, the device including two clamps connected by a flexible cable;

[0039] Figures 2a to 2d Different views of an embodiment of a device for treating sleep apnea are shown, the device comprising two clamps connected by a flexible cable having a locking member;

[0040] Figure 3a An embodiment of a device for treating sleep apnea is shown, the device comprising two clamps coupled by magnets;

[0041] Figure 3b An embodiment of a device for treating sleep apnea is shown, similar to... Figure 3a The device includes two clamps coupled by magnets, but the magnets are in different positions;

[0042] Figure 4a and Figure 4b A different view of another embodiment of a device for treating sleep apnea is shown, the device comprising two clamps coupled by magnets;

[0043] Figure 5a and Figure 5b Two configurations of an embodiment of a device for treating sleep apnea are shown, the device including two snap-on clamps connected by a rubber band;

[0044] Figure 6 An embodiment of a device for treating sleep apnea is shown, the device comprising a flexible pad;

[0045] Figure 7 Different views (cross-sectional view and side view) of the fastening device used to fix the fastening member are shown.

[0046] Figure 8a An embodiment of a device for treating sleep apnea is shown, the device including a locking plate;

[0047] Figure 8b and Figure 8c It shows Figure 8a Details of the embodiments;

[0048] Figure 9a and Figure 9b Different embodiments of a device for treating sleep apnea are shown, the device including fastening members having anchoring devices in different configurations;

[0049] Figure 10 A different configuration of another embodiment of a device for treating sleep apnea is shown, the device including a fastening member with an anchoring device;

[0050] Figure 11 Fastening members in the form of nitinol wire in different configurations are shown;

[0051] Figure 12 The fastening members in the form of expanded dental floss in different configurations are shown;

[0052] Figure 13 The steps for installing a fastening member with a knot mechanism are shown;

[0053] Figure 14 Tools for installing a device for treating sleep apnea are shown;

[0054] Figure 15a and Figure 15b An embodiment of a device for treating sleep apnea is shown, the device including elastic bands fixed to teeth in different configurations;

[0055] Figure 16 An embodiment of a device for treating sleep apnea is shown, the device including a tongue fixation portion;

[0056] Figure 17Another embodiment of a device for treating sleep apnea is shown, the device having an occlusive pad;

[0057] Figures 18a to 18f A different view of another embodiment of a device for treating sleep apnea is shown, the device including an occlusal pad and a front component;

[0058] Figures 19a to 19g Different views of the splints of a device for treating sleep apnea are shown with a two-component adhesive applied.

[0059] Figure 20 Another embodiment of a device for treating sleep apnea is shown, the device having a tension strap;

[0060] Figure 21a and Figure 21b Different views of the mesh splint used in a device for treating sleep apnea are shown;

[0061] Figures 22a to 22e A splint for treating sleep apnea is shown, the splint having an adhesive layer;

[0062] Figure 23 A splint for treating sleep apnea is shown, the splint having an adhesive coating;

[0063] Figure 24 Another embodiment of a device for treating sleep apnea is shown, the device including an inflatable component;

[0064] Figure 25a and Figure 25b Another embodiment of a device for treating sleep apnea is shown, the device comprising an inflatable balloon;

[0065] Figure 26a and Figure 26b A different view of another embodiment of a device for treating sleep apnea is shown, the device having a micro-suction surface;

[0066] Figure 27 Another embodiment of a device for treating sleep apnea is shown, the device having a foldable pad; and

[0067] Figure 28a and Figure 28b Different views of the sensor components of a device used to treat sleep apnea are shown. Detailed Implementation

[0068] The accompanying drawings illustrate various embodiments of a device for treating sleep apnea. More specifically, the device is configured to treat obstructive sleep apnea (OSA) caused by airway obstruction during sleep. The device of the present invention is designed to maintain a fixed position (or “relative position”) of the patient’s upper and lower jaws. This means that by fixing the jaws together, the device can thereby help prevent airway collapse or obstruction that could lead to apnea. Such mandibular advancement devices (MADs), particularly those shown in Figures 1 through 3, are similar to mouthguards or dental retainers and can also be used as occlusal splints as an additional function.

[0069] As will be described in further detail below, utilizing Figure 3b The device can maintain a fixed position of the jaw, with the mandible (lower jaw) held in a (slightly) forward position. This can enhance the effectiveness of the device. However, it will be understood that it is not necessary to move the mandible forward to achieve the advantages of the invention, but rather to maintain a fixed position of the upper and lower jaws (using...) Figures 1a to 1d , Figures 2a to 2d and Figure 3a A device to prevent the jaw from falling back (which may also cause the mouth to open) is sufficient.

[0070] Figure 1a The perspective view shows an embodiment of the device 100. Figure 1b The middle view is a top view (or a bottom view, the two are basically the same). Figure 1c The middle view is the rear view. Figure 1d The middle view is a front view. The device 100 has an upper portion 101 and a lower portion 102, both in the form of splints configured to fit over the teeth of the maxilla and mandible, respectively. The upper portion 101 and lower portion 102 are interconnected by a middle portion 103, which is in the form of flexible or semi-rigid cables, with three cables at the front and four at the rear (the number, position, diameter, and arrangement of the flexible cables can vary). The upper portion 101, lower portion 102, and middle portion 103 are integrally formed, i.e., made of a single material (such as a resilient plastic material). However, it is also possible that the upper portion 101 and lower portion 102 are made of a different material than the middle portion 103 (e.g., harder, softer, more rigid). The middle portion 103 (flexible cables) is flexible but has sufficient rigidity to maintain the fixed position of the maxilla and mandible while allowing a degree of movement. This allows for adaptation to different jaw positions (“occlusion”) of different patients. The rigidity of cable 103 also provides a degree of flexibility, which can be shaped by the user using a pre-set tool to determine the relative position of the upper and lower jaws. The splints 101 and 102 can have a predetermined or adjustable anterior-posterior offset to facilitate mandibular advancement, thereby further reducing sleep apnea or snoring by altering the construction of the intermediate portion 103.

[0071] The clamps forming the upper portion 101 and the lower portion 102 have a generally V-shaped cross-section, and their dimensions and shape are determined to accommodate the teeth of the upper and lower jaws. For example... Figure 1b As specifically shown, the upper portion 101 and lower portion 102 have curved shapes to accommodate the upper and lower jaw dentitions, respectively. Retention structures with barbs 104, 114 and ridges 105, 115 are configured to engage tooth surfaces or interdental spaces, thereby supporting the fixation of the device 100 into place. In this embodiment, each of the upper portion 101 and lower portion 102 has a single row of barbs 104, 114, one row on the front and one row on the back (i.e., a total of four rows). Ridges 105, 115 extend laterally parallel to the rows of barbs 104, 114, but may also be positioned vertically to aid mechanical retention. Furthermore, grooves 106, 107 are configured to avoid interfering with the labial frenulum. The splints 101 and 102 may also be coated with a moderate-release biocompatible adhesive that provides sufficient adhesion to the teeth and also allows for easy removal by the user upon waking.

[0072] The middle section 103 may have a flexible / semi-rigid cable assembly design and geometry to support the tongue under pressure or constraint during use.

[0073] The upper portion 101 and lower portion 102 are provided with holes 108, 109, 110, and 111 for receiving fastening members (not shown here, but described below), specifically dental floss. The fastening members help secure the device 100 to the teeth by passing through the interdental spaces. While the posterior (rear) holes 108 and 110 are circular, the anterior (front) holes 109 and 111 are elongated in the lateral direction. In this way, the device 100 can be adapted to a variety of patients without requiring custom-made holes. Dental floss also prevents or at least reduces lateral movement of the jaw.

[0074] Figure 1a The image shows clamps 101 and 102, which are separate from the middle portion 103, but they can also be configured as a single unit with a predefined front and rear configuration to provide mandibular displacement by one or more of the features included above.

[0075] Figure 2a and Figure 2b The perspective view shows another embodiment of the device 200 for treating sleep apnea, while Figure 2c and Figure 2d A detailed view of device 200 is shown. Device 200 is similar to device 100 described above. Therefore, Figures 1a to 1dThe corresponding description also applies where applicable. The main difference lies in the design of the middle section 203. Instead of multiple flexible cables, a single, longer flexible cable is provided to connect the upper section 201 and the lower section 202. To maintain the relative position of the jaws, the locking member 216 can be pushed onto the flexible cable when it bends, as... Figure 2c and Figure 2d As shown. The locking member 216 can advance toward the teeth to tighten the device 200, that is, to secure the upper portion 201 and the lower portion 202 together. The patient can thus control the tightness of the device 200. Further fixation can be achieved by passing dental floss (or other flexible, elongated elements) through hooks 212, 213 on the back of the upper portion 201 and the lower portion 202. For support on the teeth, barbs 204, 214 are provided on the inner sides of the upper portion 201 and the lower portion 202. Here, two rows of barbs 204, 214 (eight in total) are provided, but without ridges. Dental floss can pass through holes 208, 209, 210, 211, all of which in this embodiment have an elongated shape.

[0076] Device 200 may include sensors 220 for measuring parameters in the patient's mouth. Therefore, device 200 can also be used as a device for monitoring a patient's sleep by measuring parameters in the mouth. For example, the pH value of saliva can be an indicator of mouth breathing, as the pH value decreases slightly (typically changing from slightly alkaline to slightly acidic) when a patient breathes through their mouth. An increase in pH value can damage tooth enamel, thus increasing the risk of tooth decay. Parameters may include temperature, oxygen level, heart rate, or pH value (or various combinations thereof, including additional parameters that can be measured in the mouth). Detection of breathing patterns and / or snoring is also envisioned, which could be an indicator of the severity of sleep apnea. It will be understood that the acquired measurement data can be stored, read out, transmitted, further processed, and analyzed as needed. Reading or transmission can be performed using wired or wireless connections, such as Bluetooth or NFC.

[0077] When sensor 220 is arranged in locking member 216, locking member 216 can be positioned between the upper and lower jaws, for example, in front of the anterior teeth, placing sensor 220 in the respiratory airflow. This can improve measurement results, particularly regarding the oxygen content in the breathed air. While in this embodiment, sensor 220 may preferably be arranged in locking member 216, it will be understood that sensor 220 can be disposed in any embodiment, particularly in the middle portion of the respective device. More generally, sensor 220 can be disposed in any part of the device, as long as that part is suitable for placing the sensor in the breathed air and in direct contact with the cheek, tongue, or gums, particularly when the sensor needs to measure the oxygen level in the breathed air and other potentially valuable biometric data.

[0078] Furthermore, for any of the embodiments described herein, a kit may be provided comprising multiple devices for treating sleep apnea, wherein at least one of these devices may have the sensors described above. This may be particularly advantageous where the devices are configured for single-use (disposable) applications. For example, the kit may comprise devices for use for several days or weeks (e.g., a week or a month), wherein only some of the devices may be equipped with sensors, such as one per week, five per month, and so on. On the one hand, this can save costs. On the other hand, it may be sufficient to measure the aforementioned physical parameters once a week (i.e., only one night per week). It is also conceivable to set up the sensors separately and attach them to the devices so that measurements can be taken at the desired frequency.

[0079] Figure 3 shows a perspective view of yet another embodiment of a device 300 for treating sleep apnea. Device 300 is similar to the device described above with reference to Figures 1 and 2. Therefore, the above description also applies where applicable. However, the intermediate portion 303 is different. Instead of directly connecting the upper portion 301 and the lower portion 302, the intermediate portion 303 in the embodiment of Figure 3 has two separate components 303a and 303b. Each component 303a and 303b forms a waterproof compartment to accommodate a magnet, allowing the upper portion 301 and the lower portion 302 to be held together by magnetic force to maintain the relative position of the upper and lower jaws. Structures 303a and 303b can be designed to provide adjustment of the relative position of the magnets to provide different degrees of mandibular anterior displacement based on the patient's needs and experience. Furthermore, structures 303a and 303b can be placed on the inside (inner curved surface) of the splints 301 and 302 to provide the same magnetic retention and adjustable mandibular displacement, and can also provide tongue retention and accommodate sensors for measuring tongue biometrics. The retaining structure on the inner surface of the upper portion 301 includes only a ridge 305 extending in the transverse direction. Holes 308, 309, 310, and 311 for receiving dental floss are provided. However, only circular holes are provided, and elongated holes are not provided. A greater number of holes 308, 309, 310, and 311 (compared to the embodiment described above) and an offset arrangement allow the device 300 to be used with a variety of patients.

[0080] It should be noted that the structure of the splint described with reference to Figures 1 to 3, particularly the configuration and type of the holes for receiving dental floss and the configuration of the retaining structure including barbs and ridges, can be variable and interchangeable, and can also be combined in all embodiments. Additional fixation can be achieved by an adhesive disposed in the splint, which may or may not be activated by saliva.

[0081] It should also be noted that, for clarity, fastening components (such as dental floss) are not shown in Figures 1 through 3. Examples of fastening components will be provided below in relation to... Figure 6 A detailed explanation will be provided in Figure 15. Therefore, in conjunction with... Figure 6 The features described up to Figure 15, particularly those related to the fastening members, can be applied to the embodiments of Figures 1 through 3. More specifically, the devices of Figures 1 through 3 can be used with any of the fastening member examples described below.

[0082] Figure 4a (Cross-section view) and Figure 4b Another embodiment of a device 400 for treating sleep apnea is shown in the (front view). Similar to the splint described above, Figure 4a and Figure 4b The device is configured to accommodate the teeth of the upper and lower jaws. However, as from... Figure 4b As seen, the device 400 is smaller and can extend, for example, only on the anterior teeth (incisors). Single-strand dental floss 420, 421 is provided in each of the upper portion 401 and the lower portion 402 to extend through one interdental space in each of the upper and lower jaws. Furthermore, the device 400 can be wider to span more teeth. Therefore, more than one dental floss can be provided. Further support is provided by an offset configuration of the upper portion 401 and the lower portion 402, which allows clamping forces to be applied to the teeth. Barbs 404, 414 are provided for further support; the barbs 404, 414 may have rough surfaces and / or may be adhesive to attach to tooth surfaces. Magnets 417, 418 are configured to hold the upper portion 401 and the lower portion 402 together. Here, when the device 400 is worn, magnets 417, 418 are received at the mutually facing ends of the upper portion 401 and the lower portion 402 and attract each other to fix the relative position of the upper and lower jaws. Magnets 417 and 418 can be movable to ensure optimal engagement or to provide forward mandibular movement.

[0083] Figure 5a and Figure 5b Another embodiment of a device 500 for treating sleep apnea is shown. The device 500 is configured to snap onto teeth 11, 12. Figure 5a The diagram shows the open configuration, in which the device 500 can be placed on teeth 11 and 12. When the patient bites on the device 500, teeth 11 and 12 are pushed into the upper portion 501 and the lower portion 502, respectively, and the upper portion 501 and the lower portion 502 snap together. Figure 5b The closed configuration shown clamps teeth 11 and 12. Figure 4a and Figure 4bSimilar to device 400, the offset shape and barbs 504, 514 further support fixation to teeth 11, 12, and device 500 may have a similar (narrower) lateral dimension. Here, the middle portion 503 is in the form of a rubber band. As described in the embodiments above, when device 500 is worn, the rubber band helps maintain the relative position of the upper and lower jaws while allowing the patient to move the jaw to some extent, as explained above.

[0084] Although in the above embodiments, the upper and lower portions of the device cover the teeth on the front and back sides, in the embodiments described below, the device is arranged only on one side of the teeth, preferably the front side. In particular, in most of the embodiments described below, a plate-like or pad-like device is provided, which is adapted to engage with the teeth of the maxilla and mandible (thus forming an "upper portion" and a "lower portion", which are integrally connected by a "middle portion" (i.e., the middle portion of the plate-like or pad-like device).

[0085] exist Figure 6 In one embodiment, the device 600 includes a flexible pad, and holes 601 and 602 in the upper and lower portions of the device 600 are used to receive a fastening member 650. In the upper portion, two holes 601 are provided for each interdental space, allowing the device to adapt to various patients to maintain the relative position of the upper and lower jaws during sleep. In this embodiment, the fastening member 650 is formed as a substantially rigid fixation pin. However, dental floss may also be used.

[0086] Figure 7 Possible hole configurations that can help secure the dental floss 750 are shown, which can be applied to any embodiment using dental floss as a fastening member. A bar or bridge 702 protrudes into the hole 701, leaving only a small opening for clamping the dental floss 750. For further securing, the dental floss 750 may be provided with barbs 751. In this way, once tightened, the dental floss 750 can be prevented from slipping backward out of the hole 701.

[0087] Figure 8a Another embodiment of a device 800 for treating sleep apnea is shown, while Figure 8b and Figure 8cDetails of the device 800 are shown. The device 800 includes a plate-like member 801 for maintaining the relative position of the maxilla and mandible. Fixing members 850 are formed of elastic rings (e.g., rubber bands) that are inserted into the two interdental spaces and pass around the corresponding teeth 10. Thus, the plate-like member 801 includes a slotted opening 802 to allow insertion of the elastic ring 850. The elastic ring 850 has a rectangular cross-section, which, combined with the T-slotted opening 802, securely holds the elastic ring 850 within the plate-like member 801. To tighten the elastic ring 850, hooks 803 are provided on the front side of the plate-like member 801. Here, three hooks 803 are provided in the upper and lower portions of the plate-like member 801 to provide three levels of tension for securing the maxilla 1 and mandible 2 together, which also allows the device 800 to be used for different patients without customization. The elastic ring 850 can be rotated 90 degrees within the interdental space 13 to lock. Although in this embodiment the width of the plate-like member 801 extends only over the two anterior teeth 10, the plate-like member 801 could be wider to distribute forces more evenly over the teeth. It will be understood that the plate-like member 801 could also be placed over other teeth. This is equally applicable to other embodiments disclosed herein that have such or similar plate-like members.

[0088] Figure 9a and Figure 9b An embodiment of a device 900 for treating sleep apnea is shown, wherein the fastening member 950 (dental floss or other elongated fastening member) has anchoring members 951, 952, and 953. Figure 9a In the example, dental floss 950 has arrowhead-shaped tips 952 and 953. The arrowhead-shaped tip 952 at the "front end" has a smaller diameter, allowing it to be pushed through the interdental space (and the hole in the plate member 901), while the arrowhead-shaped tip 953 at the "rear end" has a larger diameter and acts as a stop at the plate member 901 when pulled through it. Furthermore, a spherical anchoring member 951 (or other suitable groove) is provided along the dental floss 950 to secure the fastening member 950.

[0089] Figure 9b A similar embodiment is shown. The only difference lies in the shape of the end members 952', 953' of the fastening member 950' (which also has a groove 951' along its length). Instead of having "blunt" ends, such as blocky or plate-shaped end members 952', 953', they are provided with... Figure 9a In some embodiments, sharp shapes such as arrowhead-shaped tips 952, 953, etc., are used. It will be understood that sharp shapes can be used... Figure 9a and Figure 9bAny combination of end members 952, 953, 952', 953' (or other shapes, such as spherical members, etc.) (provided that one is small enough to be inserted and the other is large enough to be used as a stop).

[0090] Figure 10 Another embodiment of a device for treating sleep apnea is shown. Instead of an integrally formed plate-like component, two separate plate-like components 1001, 1002 are provided. Similar to the embodiment in Figure 9, the dental floss 1050 has grooves 1051 along its length. Figure 10 The steps for inserting plates 1001, 1002 and dental floss 1050 are shown. Figure 10 The bottom illustration shows the final stage, where the dental floss 1050 has been tightened so that the maxilla 1 and mandible 2 are in the relative positions described herein for the purpose of treating sleep apnea.

[0091] Figure 11 The diagram illustrates another option for fastening member 1150, which can be used as an alternative to dental floss. Fastening member 1150 is formed as nitinol wire. Nitinol is a shape memory alloy whose shape changes with temperature. More specifically, the nitinol wire has a first shape at a first temperature (extraoral temperature). In this configuration, fastening member 1150 can be placed around one or more teeth. Here, a nitinol wire loop is placed around the anterior teeth (…). Figure 11 (See left-middle diagram). When the fastening member 1150 reaches a certain temperature inside the mouth, the ring closes, thereby fixing the fastening member 1150 to the teeth. Figure 11 The final tightening configuration is shown in the diagram on the right.

[0092] Figure 12 Another example of the fastening member 1250 is shown, which is in the form of expanding dental floss. More specifically, the floss expands at least a portion of its length upon contact with saliva, thereby securing it in the interdental space. Figure 12 The final tightening configuration (using the plate member 1201 as described above) is shown in the diagram on the right.

[0093] Figure 13Another example of fastening member 1350 is shown. More specifically, the steps for installing fastening member 1350 are shown (starting from the upper left corner, then the upper right corner, up to the final stage at the bottom). A portion of fastening member 1350 is provided with a tubular member 1351, which includes a braided structure, wherein the free end of another portion (or the other end of the same portion) is inserted into the tubular member 1351, which is configured to tighten upon pulling. This mechanism is referred to as a "Chinese cuff" or "Chinese finger trap." This means that while the tubular member 1351 is compressed and thus opened during the insertion of the free end, the braided structure of the tubular member 1351 automatically contracts when the fastening member 1350 tightens, thereby ensuring the relative position of the upper jaw 1 and the lower jaw 2.

[0094] While the fastening components (especially dental floss) described above can be pre-installed in the device, the floss can also be installed only when the device is in the mouth. Specifically, the locking plate 1401 is fastened to the anterior teeth by means of dental floss 1402 in a manner similar to that described above. To make the procedure more convenient for the patient, it can be as follows... Figure 14 The image schematically shows a placement tool 1405. Dental floss 1402 is inserted through an elongated tapered guide element 1403, which extends through the tool 1405. The tool 1405 is held against the teeth and then pressed together (in...). Figure 14 In the image below, (gripping on the right), the guide element 1403 is pushed by the push element 1406 to protrude toward the teeth (in Figure 14 (As shown in the image below, protruding to the left). A thread lock 1407 is provided, which allows the dental floss 1402 to be laterally displaced such that when the tools 1405 are pressed together, the dental floss 1402 is locked in the locking plate 1401, and when the tools 1405 are released, the dental floss 1402 can slide through the locking plate 1401. The dental floss 1402 is pushed through the corresponding interdental space and secured in place by means of the anchoring member 1404 at its end. The tools 1405 can then be released and removed from the tooth.

[0095] Figure 15 and Figure 15b Another embodiment of a device 1500 for treating sleep apnea is shown. The device 1500 differs from the device described above in that it is directly attached to the surfaces of teeth 11, 12. More specifically, attachments 1501, 1502 are configured to attach to the surfaces of teeth 11, 12, such as the two anterior teeth 11 of the maxillary jaw 1 and the two anterior teeth 12 of the mandibular jaw 2. Figure 15b As shown, with Figure 15aAlternatively, other teeth can be chosen to attach these attachments. Attachments 1501 and 1502 can be in the form of suction cups, allowing for easy attachment and removal. A fastening member 1550 (such as an elastic band, e.g., a rubber band) holds the maxillary 1 and mandibular 2 together and secures them in a relative position suitable for treating sleep apnea. Another option (not shown) could be to wrap an elastic band around the patient's chin instead of attaching the attachments to the mandibular teeth.

[0096] Figure 16 Another embodiment of a device 1600 for treating sleep apnea is shown (components of the mandible 2 are not shown here). The device 1600 includes a tongue-holding portion 1660 configured to hold the tongue 20 in an forward position to prevent the tongue 20 from obstructing the airway. The tongue-holding portion 1660 includes a "shelter" (or "shield") made of a flexible material (e.g., silicone) that rests on the tip of the tongue 20 and is held to the tongue 20 by suction. The tip of the tongue-holding portion 1660 has a magnet 1661 (e.g., embedded). The lower portion 1602 of the device 1600 (i.e., the portion configured to rest on the teeth 12 of the mandible 2) also has a magnet 1603 to hold the tongue 20 in the forward position by magnetic force.

[0097] Figure 17 Another embodiment of a device 1700 for treating sleep apnea is shown, which takes the form of a mandibular advancement device. It will be understood that this device, as well as all other devices described herein, can also be used to treat other breathing disorders, such as for snoring relief. For simplicity, all these breathing disorders are generally referred to as “sleep apnea” as described earlier in this document. Device 1700 has an upper portion 1701, a lower portion 1702, and a guide rail 1703 that allows linear movement between the upper portion 1701 and the lower portion 1702. The guide rail 1703 allows device 1700 to be moved to a position comfortable for the user. The upper portion 1701 and the lower portion 1702 are configured as “occlusal pads” that can be positioned, respectively, on the last teeth (molars) of the maxilla and mandible, such as the last three teeth, or more or fewer teeth. The upper portion 1701 and the lower portion 1702 are connected by straps 1704 and 1705. The lower band 1705 is configured to extend on the posterior side of the lower teeth. The upper band 1704 is configured to be positioned on the anterior side of the upper teeth, thereby providing maximum safety to the device 1700 without increasing its size.

[0098] Figures 18a to 18fVarious views of another embodiment of a device 1800 for treating sleep apnea are shown. Device 1800 has two rear components 1801, 1802 (such as splints or occlusal pads) configured to receive the last posterior teeth of the maxilla and mandible, such as the last three teeth (or only one or two, or more, such as four). Figure 18a As shown, occlusal pads 1801 and 1802 may have a receiving structure to improve fixation on the teeth through adsorption. Alternatively, as Figure 18b As shown, no structure is required. Fixation can be achieved, for example, by adhesives or adaptable materials (especially two-component materials), as will be described herein. The device 1800 has a front part 1803 connected to a connecting portion 1804 (such as a band, etc.) to receive the maxillary and mandibular anterior teeth. The front part 1803 is designed such that the mandible moves forward by approximately 3 mm while keeping the mandible in an anterior position. For this purpose, the front part 1803 has an upper cavity for receiving the upper anterior teeth and a lower cavity for receiving the mandibular anterior teeth, wherein, within the front part 1803, the lower cavity is offset in a forward direction relative to the upper cavity. The front part 1803 has an opening 1805 configured to receive a positioning device, such as a rod 1806, etc. The rod 1806 is inserted into the opening at an angle to induce the mandible to move to a position. Once the device 1800 is fixed to the teeth, for example by adhesives or veneer materials (e.g., curing after a few minutes), meaning the relative position of the maxilla and mandible is fixed, the rod 1806 can be removed.

[0099] Figures 19a to 19g Different views of an embodiment of a splint 1901 for treating sleep apnea are shown. More specifically, the splint 1901 is designed to contain a two-component adhesive (or more generally, an adhesive material). The two-component material is disposed in a pouch-like reservoir 1902 having two chambers 1904, 1905 to keep the two components of the material separate. The reservoir 1902 has a mixer 1906 such that the two components of the material can be mixed once the reservoir 1902 is squeezed. The mixed material is dispensed into the splint 1901 via an opening 1907. The splint 1901 is hollow and has holes 1903 or a mesh structure such that the mixed material can fill the upper and lower portions of the splint 1901. Teeth are placed in the mixed material and can be secured once the material has cured after a few minutes. It will be understood that the application of the two-component adhesive (adhesive material) can be applied to any of the embodiments described herein.

[0100] Figure 20Another embodiment of a device 2000 for treating sleep apnea is shown, which is in the form of a mandibular advancement device. An upper portion 2001 and a lower portion 2002 for receiving and fitting to the last teeth (e.g., the last three teeth) are connected by a guide rail 2003, which serves as a similar... Figure 17 The sliding mechanism of this embodiment is provided. Two straps 2004 are connected by a locking element 2005 (“clasp”). The straps 2004 are connected to and extend from the lower portion 2002 at an angle such that they extend over the upper teeth. The user can adjust the amount of mandibular advancement by tightening or loosening the straps 2004.

[0101] Figure 21a and Figure 21b Different views of the splints 2101, 2102 of the device 2100 for treating sleep apnea are shown. The mesh structure 2103 facilitates the dispensing of adhesives or bonding materials. It will be understood that the mesh structure can be applied in any embodiment where appropriate.

[0102] Figures 22a to 22e A splint 2201, 2202 of a device 2200 for treating sleep apnea is shown, the splint 2201, 2202 having an adhesive layer. A first component 2210 of material is applied and is covered by an isolation layer 2211. Then a second component 2212 of material is applied and is covered by another isolation layer 2213. Once the user places the device 2200 in their mouth or engages the biting device 2200, the isolation layers 2211, 2213 are dissolved by saliva, allowing components 2210 and 2212 to come into contact with the teeth and solidify, thereby adhering to the teeth. It will be understood that this can be applied in any embodiment where appropriate.

[0103] Figure 23 A splint 2301 for a device used to treat sleep apnea is shown. A first component 2310 of an adhesive or bonding material is pre-installed on the device. The device may be housed in a kit that also has a container containing a second component of the material (which is an activator), such as a liquid powder or paste. Once the second component is applied, the material cures.

[0104] Generally, it's conceivable to incorporate fragrances into the bonding or adhesive materials. When the user uses the device, the fragrance is released. Fragrances could include, for example, peppermint, chocolate, fruit, chamomile, lavender, eucalyptus, and herbs. Products to soothe sore throats or disinfectants to alleviate bad breath could also be included. Furthermore, the device could be designed to release nicotine to help smokers quit, similar to the function of nicotine patches.

[0105] Figure 24Another embodiment of a device 2400 for treating sleep apnea is shown, which includes an inflatable component, or the device may be fully inflatable. The device 2400 is equipped with a small squeeze pump (not shown) that allows a user to inflate the device 2400 to fit their teeth. A manual squeeze pump can be inserted into ports 2401, 2402.

[0106] Figure 25a and Figure 25b Another embodiment of a device 2500 for treating sleep apnea is shown, which includes an inflatable balloon 2501. The balloon 2501 can be inflated by means of a pump (not shown), which can be connected to a port 2502. When the balloon 2501 is inflated, it causes the mandible to move forward, thereby forming a mandibular advancement device.

[0107] Figure 26a and Figure 26b A different view of another embodiment of a device 2600 for treating sleep apnea is shown, the device having a micro-suction surface. Similar to other embodiments, two clips or pads 2601, 2603 are provided, interconnected by a band 2603. The device 2600 is configured to be secured to the teeth using a micro-suction technique integrated into the main design of the device in the form of tape or other means. A micro-suction cup 2604 has sufficient suction to maintain jaw closure but allows the user to remove the device 2600 with sufficient pull and reinstall it as needed within a sleep cycle. Furthermore, this technique can be combined with boil-and-bite material. This allows the device to perfectly conform to the tooth area, thereby enhancing the retention of the micro-suction tape (or material). It will be understood that the micro-suction technique can be combined with other adhesive options.

[0108] Figure 27 Another embodiment of a device 2700 for treating sleep apnea is shown. While the device 2700 can be adhered to the teeth by any of the methods described above, it has a special clamping design. The clamp 2701 has foldable side portions 2702, 2703. When the user bites on the device 2700, the side portions 2702, 2703 will fold upward or "click," thereby enveloping the teeth to secure the device 2700 in place.

[0109] Figure 28a and Figure 28bDifferent views of the sensor assembly of a device 2800 for treating sleep apnea are shown. A patch 2801 is attached to the device 2800 by means of a connecting wire or cable 2802. The patch 2801 can then be placed anywhere on the face, and the patch 2801 contains all the electronic components. It will be understood that, depending on the size and volume of the components and the need for placement inside or outside the mouth, the electronic components may also be distributed between the intraoral and external parts of the device 2800 (i.e., the patch 2801). This configuration can be applied to any sleep apnea device with sensors. As mentioned above, the sensors can measure various parameters. Devices with sensors can also be configured in a kit as described above.

[0110] While at least one exemplary embodiment of the invention has been described above, it should be noted that numerous corresponding variations exist. Furthermore, it will be understood that the described exemplary embodiments are merely non-limiting examples of how the invention can be implemented and are not intended to limit the scope, application, or configuration of the apparatus and methods described herein. Rather, the foregoing description will provide those skilled in the art with a means of implementing at least one exemplary embodiment of the invention, wherein it must be understood that various changes can be made to the function and arrangement of the elements of the exemplary embodiments without departing from the subject matter defined by the appended claims and their equivalents.

Claims

1. A device for treating sleep apnea, the device comprising an upper portion, a lower portion, and a middle portion, the upper portion being configured to rest on at least one tooth of a patient's maxilla, and the lower portion being configured to rest on at least one tooth of the patient's mandible, wherein, The intermediate portion is configured to connect the upper portion and the lower portion together when the upper portion and the lower portion are placed on the patient's maxillary and mandibular teeth to maintain the relative position of the maxilla and the mandible. The device also includes at least one fastening member configured to engage with at least one interdental space of each of the maxilla and the mandible to secure the upper portion and the lower portion to the maxillary and mandibular teeth, respectively.

2. The apparatus according to claim 1, wherein, The upper portion and the lower portion each have at least one fixing device, which is used to fix the fastening member to the upper portion and the lower portion respectively.

3. The apparatus according to claim 2, wherein, The fastening device includes at least one of an opening, a buttonhole, a pin, and a hook for engaging with the fastening member.

4. The apparatus according to any one of the preceding claims, wherein, The fastening component includes at least one dental floss.

5. The apparatus according to any one of the preceding claims, wherein, The fastening member includes one or more strands of dental floss, one or more floss loops, or a combination thereof, wherein the fastening member includes at least one strand of dental floss for each of the upper portion and the lower portion, at least one strand of dental floss used together for both the upper portion and the lower portion, or a combination thereof.

6. The apparatus according to any one of the preceding claims, wherein, The upper portion and the lower portion are formed into dental splints, each of which is configured to accommodate the teeth of the maxilla and the mandible, respectively.

7. The apparatus according to claim 6, wherein, The splints each have a retaining structure on their inner side, and when the splints are placed on the teeth and the retaining structure engages with the surface of the at least one tooth, the inner side faces the at least one tooth.

8. The apparatus according to claim 7, wherein, The retaining structure has at least one of one or more ridges, barbs, spherical protrusions, and pins.

9. The apparatus according to any one of the preceding claims, wherein, The upper portion, the lower portion, and the middle portion are formed as a single integral part.

10. The apparatus according to any one of the preceding claims, wherein, The intermediate portion includes at least one elongated connecting member that connects the upper portion and the lower portion.

11. The apparatus according to any one of claims 1 to 8, wherein, The upper portion and the lower portion are formed as separate pieces, and the middle portion includes a first portion attached to the upper portion and a second portion attached to the lower portion, the first portion and the second portion being separate from each other and each containing a magnet, such that the first portion and the second portion can be magnetically attached to each other.

12. The device according to any one of the preceding claims further includes a locking member configured to engage with the intermediate portion or the fastening member to secure the relative position of the maxilla and the mandible.

13. The apparatus according to any one of the preceding claims, wherein, The fastening member has an anchoring mechanism for anchoring in the tooth gap.

14. The device according to any one of the preceding claims further includes a tongue fixing portion attached to or capable of being attached to at least one of the upper portion and the lower portion, the tongue fixing portion being configured to be placed on at least a portion of the patient's tongue to fix the tongue and prevent the tongue from moving toward the patient's throat.

15. The apparatus according to any one of the preceding claims further includes at least one sensor for measuring at least one parameter in the patient's mouth.

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