Device and method for preventing bruxism and / or craniomandibular dysfunction (CMD)

Abstract

The invention relates to a device for treating and / or preventing and / or testing for bruxism and / or craniomandibular dysfunction (CMD) and / or the effects thereof, which device is designed to be arranged in an oral cavity, preferably between the upper jaw and the lower jaw, of a user and is designed to ensure a distance between a chewing surface of the lower jaw and a chewing surface of the upper jaw, said device comprising: an upper support element (502) which is designed to come into contact with the palate, a lower support element (504) and a spacer connecting the upper support element and the lower support element, wherein the spacer (506) is designed to ensure the spacing when forces occur in the oral cavity during use, wherein the spacer extends in an offset manner with respect to a chewing surface between the upper jaw and the lower jaw and in particular within the dental arches.

Description

[0001] Device and method for preventing bruxism and / or craniomandibular dysfunction (CMD)

[0002] The present invention relates to a device for reducing and preventing the negative effects of bruxism and / or craniomandibular dysfunction (CMD) and a method for detecting bruxism as well as a method for manufacturing a device individually adapted to a user.

[0003] Bruxism is repetitive chewing muscle activity characterized by jaw clenching, teeth grinding, and / or tensing or shifting of the mandible without tooth contact. Bruxism can lead to many health problems, such as enamel abrasion, increased wear and / or damage to the periodontal tissues, pain and damage in the masticatory muscles, temporomandibular joint, and neck muscles, sensitive teeth, tooth mobility and tooth loss, headaches, tinnitus, dizziness, visual disturbances, and nausea. To prevent bruxism, current dental techniques involve the placement of splints over or on the occlusal surfaces of the upper or lower teeth, separating the occlusal surfaces. The common design element of all splints is the covering of the occlusal surface of one or more teeth.All teeth are covered, so that the force generated by bruxism continues to act on the teeth. Such splints are known, for example, from US 8,196,587 B2 and EP 2 923 680 A1. In the prior art, splints reduce the abrasion / wear of tooth enamel caused by bruxism by covering the occlusal surface. They can better distribute damage (for example, from receding gums) and / or reduce it by up to 50% and reduce pain. Nevertheless, even when using a splint, further damage or pain is possible. A permanent reduction of bruxism activity is not achieved with splints. In addition, splints can wear down or break after some time due to biting force, and there is a risk of harmful microplastics being released.

[0004] Furthermore, spacers are known from the prior art, e.g. from DE 20 2020 100998 U1, ES 2 358 937 A1, KR10-1922091 B1, WO 2011 / 162604 A1. However, the devices from the prior art have various disadvantages, such as being constructed like a rail, requiring active intervention and / or being uncomfortable to wear, using magnets near the brain, and exhibiting side effects on oral health.

[0005] The present invention aims to further improve known devices and methods for testing for and treating bruxism using biofeedback. In biofeedback treatment, patients receive feedback on their bodily functions (e.g., visual, auditory, or tactile), and positive changes in these bodily functions are reinforced, enabling them to learn how to influence these functions. Ultimately, in the context of bruxism, this can lead to a reduction in mandibular movement and the associated symptoms. While splints are intended to reduce or at least redistribute biting force, biofeedback aims to make bruxism noticeable. Prior art biofeedback devices are applied both intraorally and extraorally. A disadvantage of the existing technology lies in their size and arrangement, which reduce wearing comfort.

[0006] Furthermore, biofeedback devices are known from the prior art, e.g. from US 4,995,404 A, US 5,490,520 A, ES 1305106 U, US 2014 / 0190491 A1 , ES 1305106 U, EP 1 706 078 B1.

[0007] It is therefore the object of the invention to provide an improved device that overcomes the aforementioned disadvantages. The common technical idea is to attach a device for improving bruxism or craniomandibular dysfunction (CMD) to a soft tissue in the oral cavity. In a preferred embodiment, the device does not exert any force on the occlusal surfaces that could lead to damage. In a further preferred embodiment, the device does not touch the teeth or at least does not exert any pressure on the teeth. This aims to ensure that (a) no or only a minimal force is exerted on one or more teeth (even laterally), thus preventing malocclusion through the use of the device according to the invention, and (b) this results in a small device size, which reduces the likelihood of needing to miniaturize the device for a particularly small dentition (for example, in children and adolescents).

[0008] Solutions are proposed in the independent claims. Preferred embodiments are specified in the dependent claims.

[0009] One aspect of this proposal is a device for the treatment and / or prevention of, and / or testing for, bruxism and / or craniomandibular dysfunction (CMD) and / or their consequences. The device is designed to be positioned in the oral cavity, preferably between the upper and lower jaws of a user. The device is designed to maintain a distance between the occlusal surfaces of the lower jaw and the occlusal surfaces of the upper jaw, thereby reducing or preventing stress on the stomatognathic system, particularly the teeth and the temporomandibular joint. The device comprises an upper support element designed to contact the user's palate. Furthermore, the device includes a lower support element designed to provide a stable and comfortable support surface for the lower jaw during use in the oral cavity.The upper and lower support elements are connected by a spacer. The spacer is designed to reliably maintain the distance even under the forces occurring in the oral cavity during use, thus ensuring that the desired distance between the occlusal surfaces of the upper and lower jaws is maintained.

[0010] The spacer is positioned offset from a chewing surface between the upper and lower jaws, and specifically within the dental arches. This offset placement prevents direct contact or support with the chewing surfaces. This reduces potential malocclusion and minimizes the risk of damage to the tooth surfaces.

[0011] Preferably, the lower support element is positioned on the teeth of the lower jaw, while the upper support element rests exclusively on the palate of the upper jaw and maintains sufficient distance from the teeth. If the upper support element rests loosely on the teeth or is positioned too close to them, there is a risk of developing malocclusions and other damage due to potentially uncontrolled force exerted on one or more teeth. Alternatively, if the device is attached to the upper jaw, it should be fixed to the teeth by a medical professional in such a way that no malocclusion develops and the device can be removed by the user during the day. This placement on the palate means that the body perceives the biting pressure more quickly, even during sleep, than with the state-of-the-art placement between the occlusal surfaces.This results in less force being exerted, which in turn reduces the resulting damage – bruxism is considered a risk factor for the development and / or progression of craniomandibular dysfunction (CMD). The device is preferably positioned palatal to the central incisors (on the palate behind the front teeth), as the forces exerted there are lower than, for example, on or near the molars, due to physical and biomechanical reasons. It should be noted that the resulting damage is not proportional to the force exerted, but rather increases disproportionately with increasing force: for example, a light bite or a slight force exerted on the tongue or other structures in the mouth causes no damage; a strong bite or a large force exerted on the tongue or other structures in the mouth can lead to significant, sometimes irreparable, damage.

[0012] The spacer is positioned outside the occlusal line, i.e., offset from a chewing surface between the upper and lower jaw. In the context of this application, "outside the occlusal line" or "offset from a chewing surface between the upper and lower jaw" means the following: Although the lower jaw is mobile and it is possible that the device and / or the spacer could move into the area between the chewing surfaces or into the occlusal line through active movement by the user, the device is designed, for example, by its height or width, in such a way that this does not occur during normal wear and when the desired, comfortable positioning is achieved. The dental arch, and depending on the user, also the concave arch, i.e.,The upward curve of the palate acts as a natural obstacle, forming a mechanical barrier, particularly when the appliance is attached to the palate, to prevent the spacer from unintentionally penetrating the functional occlusal area. If the appliance—and thus the spacer—is shifted ventrally (forward) from its position on the palate toward the occlusal line, this can lead to mouth opening and / or significantly impair wearing comfort. While such positioning can be achieved through conscious movement while awake, during sleep such a coordinated movement—that is, not just mouth opening but a simultaneous forward shift of the mandible—is at least very rare, if not impossible, even in the average person.In bruxism, the disease process leads to an increased frequency of mouth closure due to unconscious teeth clenching or grinding, which further reduces this risk. For users in whom the device nevertheless ends up positioned within the occlusal line to a significant extent, the device could, for example, be fixed to the teeth on both jaws, thus preventing movement between the occlusal surfaces. The term "offset from a chewing surface between the upper and lower jaw" should therefore be understood in terms of functional positioning: The spacer may partially extend into or be located in the area between the dental arches, but must be positioned outside the occlusal line at least on one chewing surface, preferably in the upper section. The crucial factor here is the functional effect, i.e.,that the positioning of the spacer reduces or prevents the force being applied. Furthermore, it is clarified that the term "offset relative to a occlusal surface between the upper and lower jaw" within the meaning of this application can also refer exclusively to the occlusal surface of a single tooth. This means that the offset positioning of the spacer can be relative to the occlusal surfaces of several individual teeth, relative to all occlusal surfaces of the entire upper and / or lower jaw, or explicitly relative to the occlusal surface of a single tooth.

[0013] This offset positioning represents a significant difference from the current state of the art. It allows the distance between the antagonistic occlusal surfaces to be maintained independently of the occlusal line – that is, the imaginary connecting line. This achieves a functional decoupling of the occlusal surfaces, leading to targeted mechanical relief of the teeth. This relief has a particularly beneficial therapeutic effect in cases of parafunctional activities such as bruxism and craniomandibular dysfunction (CMD).

[0014] In preferred embodiments, at least a substantial portion of the spacer is offset from a chewing surface. It is particularly advantageous if at least 60% of the spacer material is arranged offset from a chewing surface. This ensures that even if a section of the spacer runs close to or begins near the chewing surfaces, the essential function of the spacer is guaranteed by the offset arrangement. This prevents a reproduction in which the spacer partially begins on the chewing surfaces or is integrally formed with a support element from circumventing the functional scope of protection of the invention.The design, in which at least 60% of the spacer material runs within the dental arches and offset from an occlusal surface, ensures reliable maintenance of the distance between the upper and lower jaws while simultaneously achieving a particularly compact design. In further preferred embodiments, for example, in a one-piece design of support element and spacer or a one-piece design of spacer and retaining plate, the freestanding section of the spacer can be designed to run offset from an occlusal surface between the upper and lower jaws and, in particular, within the dental arches. For the purposes of this application, the term "freestanding" refers to that section of the spacer which does not serve for attachment to at least one support element, but, for example, projects out from such a support element.This is recognizably another design element (such as a spacer in the form of a joint or hinge). In a further preferred embodiment, at least one support element is also positioned such that it is offset from a chewing surface between the upper and lower jaw and, in particular, within the dental arches.

[0015] In a further aspect, a device for the treatment and / or prevention of and / or testing for bruxism and / or craniomandibular dysfunction (CMD) and / or its consequences is proposed, which is designed to be placed in the oral cavity, preferably between the upper and lower jaws, of a user, and which is designed to ensure a distance between a occlusal surface of the lower jaw and a occlusal surface of the upper jaw, wherein the device comprises an upper support element designed to make contact with the palate, a lower support element, and a spacer connecting the upper support element and the lower support element, and is characterized in that at least one joint is formed between the upper and / or lower support element and the spacer.

[0016] By incorporating at least one joint between the support elements and the spacer, the device can be adapted with exceptional flexibility to the individual anatomical conditions of a user. The joint allows for adjustable or adaptive relative movement between the support elements and the spacer, thus accommodating different jaw positions or mandibular movements without compromising wearing comfort. Furthermore, it enables the use of identical components by different users. This design contributes to increased wearing comfort and allows for a more even distribution of pressure in the oral cavity. In addition, the joint arrangement facilitates handling and, if necessary, the replacement of individual components, which is particularly advantageous for long-term use.

[0017] In a further aspect, a device for the treatment and / or prevention of and / or testing for bruxism and / or craniomandibular dysfunction (CMD) and / or its consequences is proposed, which is designed to be placed in the oral cavity, preferably between the upper and lower jaws, of a user, and which is designed to ensure a distance between a occlusal surface of the lower jaw and a occlusal surface of the upper jaw, wherein the device comprises an upper support element designed to make contact with the palate, a lower support element, and a spacer connecting the upper support element and the lower support element, and is characterized in that at least one of the support elements and / or the spacer has an elastic component.

[0018] Integrating at least one elastic component into a support element or spacer can enable targeted damping of the forces occurring in the oral cavity during use. The elastic component can be made of a compliant or deformable material and helps to absorb peak loads, such as those that occur during nighttime teeth grinding. This protects, for example, the temporomandibular joint and teeth. The elastic component thus supports not only the functionality of the device but also its long-term tolerability for the user. It is particularly advantageous if the elastic component is combined with a hinged connection, so that both flexibility and damping properties are combined in one device.The elastic component can also be used to generate biofeedback for the user, for example, in one embodiment as a snap disc or as a piezoelectric element. This function can also be combined with a hinged connection, which increases the likelihood of triggering the biofeedback.

[0019] Preferably, the lower support element comprises a contact section for contacting a portion of the mandible and a retention section for connection to the spacer. This division into contact and retention sections allows the lower support element to be optimally adapted to the anatomy of the mandible, thus increasing the accuracy of fit and wearing comfort. The contact section ensures secure and gentle support on the mandible without placing unnecessary stress on the teeth or gums. The separate retention section enables a stable and flexible connection to the spacer. This allows the device to be individually adapted to various anatomical shapes and sizes in the oral cavity. This can simplify the fabrication, assembly, and, if necessary, replacement of individual components. The contact and retention sections can also be manufactured as a single unit.

[0020] Preferably, the contact section of the lower support element comprises the following: one or more dental appliances placed in the oral cavity, in particular braces or splints, which may also comprise only one tooth and / or a part of the dental arch, and / or one or more connecting means for temporarily or permanently connecting the device to one or more dental appliances, in particular braces or splints, which may also comprise only one tooth and / or a part of the dental arch or a locking mechanism, wherein the connecting means may, for example, have a locking mechanism, a through hole and / or a thread, and / or one or more fastening elements for attaching the device to one or more teeth of the mandible or to other locations in the oral cavity.

[0021] This design offers a high degree of flexibility in the adjustment and attachment of the device. The ability to use or incorporate various dental appliances or attachments allows the device to be optimally adapted to the individual anatomical conditions and needs of each user. This increases wearing comfort, stability, and everyday usability. Furthermore, the modular connection with existing dental appliances (such as braces or splints) enables easy integration into existing dental restorations without the need for additional invasive procedures. The locking mechanism facilitates attachment and detachment. The various attachment options ensure that the device remains securely in place and can reliably exert its therapeutic effect.Because the spacing eliminates the need for complete coverage of all occlusal surfaces to reduce tooth structure loss caused by attrition, the appliance can be attached with a significantly smaller splint, thus increasing wearing comfort. This also distinguishes it from most conventional splints. The smaller splint, in turn, reduces the individual variations in the dental arches of different users, which can then allow for size variations or even a single, standardized size.

[0022] Preferably, the lower support element comprises one or more dental appliances, in particular dental splints, inserted into the oral cavity, which are made in particular of a thermoplastic, dimensionally stable and resilient material that is not soft in the sense of silicone, and which cover at least one tooth of the left and right quadrants, i.e. a total of at least two teeth, and / or fill the interdental spaces in front of, between and / or behind these teeth with a thermoplastic material, preferably in longitudinal strips, spherical shape, wedge shape or conical design along the interdental spaces, in order to enable a form-fitting and / or force-fit anchorage to the teeth and to allow the splint to be adjusted without medical personnel.

[0023] The use of thermoplastic material offers several advantages: (1) Individual adaptation: The thermoplastic material allows the dental appliance to be adjusted directly in the user's mouth to the individual shape and position of the teeth, without the need for medical professionals. (2) Secure anchorage: Filling the interdental spaces ensures a stable, form-fitting, and / or force-fit fixation of the dental appliance to the teeth, reducing the risk of the appliance slipping or falling out during everyday use. (3) Material and comfort advantages: Since it is not necessary to cover the entire dental arch, but only at least two teeth, less material is required, which increases wearing comfort and reduces discomfort in the mouth.(4) Flexibility: The solution is particularly suitable for patients with partial dentition, gaps, or special anatomical conditions, as the splint can be flexibly adapted to different situations. In contrast to conventional occlusal splints, the surface of the splint and thus the tooth guidance are significantly less relevant, since, according to the invention, the teeth no longer or only minimally contact the splint, which reduces the risk of dental and jaw misalignments caused by the lack of individual adaptation.

[0024] In the context of this disclosure, "soft" in the sense of silicone refers to a material behavior characterized by reversible, elastic deformability under mechanical stress. The material exhibits low hardness, e.g., Shore A hardness < 30 (according to DIN ISO 7619-1, scale A), and returns to its original shape after the stress is removed, without permanent plastic deformation. This deformability is comparable to that of cross-linked polydimethylsiloxane (PDMS), as typically used in medical or technical silicones.

[0025] Preferably, the retention section of the lower support element, which may, for example, have a quarter-sphere surface or a geometrically similar curved shape, in particular a spheroidal or elliptically curved surface in the area of ​​the tongue, has an inelastic retention plate, which preferably extends along the edge of or over the occlusal surfaces and around the tongue, in particular in the form of a semicircle, and which is permanently or temporarily connected to the spacer and / or the contact section of the lower support element in order to partially or completely absorb the force generated by the movement of the mandible, wherein the retention plate is made of a dimensionally stable material that does not deform significantly under load and contributes to the stabilization and fixation of the device in the oral cavity.

[0026] The design of the retention section of the lower support element, featuring an inelastic retention plate preferably located at the edge of the occlusal surfaces or on the occlusal surfaces themselves, as well as around the tongue, ensures that more force is required to cause unwanted deformation of the device. By placing the retention plate at the edge of the occlusal surfaces, preferably at least partially adjacent to the teeth, additional space is created for the integration of fastening elements (e.g., screws), enabling secure, force-fit, and form-fit fixation of the device. If the retention plate is made larger towards the teeth, it can rest directly on the occlusal surfaces, allowing some of the forces generated during jaw closure to be absorbed and distributed across the occlusal surfaces.This reduces the need for additional support material around the teeth, minimizing both the overall volume of the device and the potential for disturbance in the oral cavity.

[0027] Furthermore, the geometry of the retention plate—particularly its semicircular, quarter-spherical, or elliptical shape—allows for precise adaptation to the individual anatomical conditions of the patient. In the case of a quarter-spherical surface (or a similar elliptical shape), the retention plate is curved upwards, further increasing the structural stability of the device. This reduces material usage. The retention plate can be attached both temporarily and permanently, which affects its ease of cleaning and replacement. Overall, this technical design contributes to optimally distributing mechanical loads, improving the positioning and fixation of the device, and maximizing its suitability for everyday use and therapeutic effectiveness.

[0028] Preferably, a support element is formed by recesses for the retention plate and material below and / or above the retention plate to partially or completely absorb the force generated by mandibular movement and simultaneously prevent or minimize direct contact between the teeth and the retention plate, wherein the retention plate is completely or partially encased or lined with an elastic material in those areas where direct tooth contact is possible – particularly in the area of ​​the occlusal surfaces and the vestibular and lingual sides – and / or consists of a material, for example PMMA, photopolymer resin, thermoplastic and / or dimensionally stable plastics, and / or a shape that prevents or minimizes damage to the tooth enamel, for example by an additional buffering cover element arranged between the retention plate and the tooth surface.and where the mounting plate, through its geometric design and choice of material, is designed to ensure a stable position even under asymmetrical loads.

[0029] The material beneath the retention plate stabilizes its position under force. By embedding the retention plate in the material of the lower support element—for example, through targeted recesses and material above and below the retention plate—it is prevented from tilting or shifting upwards or downwards when force is not applied precisely in the center. This ensures that the retention plate remains stable in its position even under asymmetrical loads. Furthermore, the material above the retention plate ensures that the forces generated by mandibular movement are not solely concentrated on the retention plate, but are partially absorbed and distributed by the surrounding material.

[0030] Another significant advantage of this embedding technique is that – especially when using a retention plate made of a harder material than tooth enamel (such as metal) – direct contact between the metal and the tooth can be better avoided. This significantly reduces the risk of tooth damage, such as abrasion or enamel fractures. At the same time, the tongue is also protected from direct contact with the retention plate, improving comfort. Overall, this technical design contributes significantly to the stability, comfort, and suitability of the appliance for everyday use.

[0031] Wrapping the retention plate with an elastic material in the areas where tooth contact is possible, or using a suitably soft or specially shaped material for the retention plate, prevents direct contact between the hard retention plate (especially in metallic versions) and tooth enamel, thus preventing enamel damage such as abrasion, cracks, or chipping. The comfort of wearing the appliance is further enhanced by a material surrounding the retention plate, particularly when the tongue reaches the affected areas.

[0032] In a preferred embodiment, the elastic covering of the retention plate can be designed as an interchangeable element. This allows for individual adaptation to different anatomical conditions or comfort needs of the user. The covering can, for example, be designed as a snap-on sleeve, a snap-in inlay, or a modular cover and be made of materials such as silicone, TPU, photopolymer resin, or thermoplastic elastomers. Interchangeability facilitates cleaning and increases the device's service life. The covering can be attached temporarily or permanently, with plug-in, clamp, or snap connections being particularly preferred. Materials for the retention plate could include, for example, titanium, biocompatible stainless steel, PMMA, or Key Splint Soft.

[0033] Preferably, the retaining plate is permanently or temporarily connected to a support element and / or the spacer, and / or the retaining plate is designed to additionally secure the spacer against unintentional falling out and / or asymmetrical and / or faulty or unstable positioning within a recess, such that it enables a positive and / or force-fit fixing in conjunction with at least one screw and a nut or a thread formed in the retaining plate and / or in the spacer, wherein the nut or the thread is preferably arranged outside or in a recess of the lower support element and the retaining plate is secured by the support element surrounding it in conjunction with the screw inserted through it.

[0034] The permanent or temporary connection of the retention plate to a support element, connecting element, dental appliance, or fastening element—for example, by screwing it in—ensures that the retention plate remains reliably fixed in the device. This prevents the retention plate from accidentally falling out, which could otherwise lead to a loss of function of the device or, in the worst case, to swallowing the retention plate or obstructing the airways. The connection thus increases user safety and guarantees the continued functionality of the device in daily use. This can be achieved in various ways: For example, a screw can be inserted from the front (i.e., from the direction of the mouth opening) through the support element into the retention plate, which has a thread for this purpose.Alternatively, the screw can be inserted from above, for example, within the dental arch next to the teeth, with the retaining plate also having a thread in this configuration. These two insertion directions have the advantage of being furthest away from the tongue, thus increasing wearing comfort. Optionally, nuts can be used for additional fixation, taking into account the limited space. Therefore, it is also recommended to use screws with thread sizes M1 to M3, which are also only a few millimeters long, preferably 3 to 10 millimeters.

[0035] As an alternative to screws, the mounting plate can also be connected to the device using other mechanical connection techniques. These include, in particular, snap-fit ​​connectors, bayonet fittings, clamp connections, snap connections, friction fits, or combinations of these techniques. These options allow for tool-free assembly and disassembly, which is especially advantageous for modular or cleanable device designs. The choice of connection depends on the desired reversibility, load-bearing capacity, and the material properties of the components involved. Alternatively, the connection between the mounting plate and the support element can also be created by a connection made under force or heat, particularly when using thermoplastic or deformable materials.

[0036] Preferably, a support element and / or the dental appliances and / or the retaining plate has one or more recesses for receiving the spacer, wherein the spacer may have a section with an external thread for screwing into one of the support elements and / or the retaining plate, and / or wherein the recesses for the spacer are designed to enable a positive-locking connection, in particular a positive-locking rotary connection, or an elastically preloaded bearing, wherein the connection or bearing may in particular be designed as a clamping joint, clamping hinge, cylindrical joint, snap joint, ball joint, cardan or universal joint, single-axis joint, snap connection, detent plug connection, spring mechanism or a combination thereof.

[0037] The device offers a particularly reliable and flexible method for the stable connection of a spacer to a support element, dental appliance, or retention plate. The integrated recesses, which allow for a positive-locking connection or elastically pre-tensioned mounting, ensure that the spacer is securely fixed and does not unintentionally tilt or become dislodged. Precise positioning and lasting stability of the spacer are essential to guarantee the functionality of the entire device. For example, the spacer can be shaped like a pair of pliers to grip the retention plate, with the screw being passed through all three parts from above and simultaneously tightened. The option of screwing the spacer in place via an external thread further increases the mechanical strength of the connection.At the same time, the design of the connection as a clamping joint, ball joint, snap connection or one of the other mentioned variants allows for a high degree of adaptability to different requirements regarding mobility, restoring force or ease of assembly.

[0038] Preferably, the distance created by the spacer reduces the force exerted on a chewing surface and / or dental appliance and / or prevents direct contact between opposing chewing surfaces and / or between a chewing surface and a dental appliance and / or the lower support element.

[0039] The device is characterized by the fact that the spacer creates a gap specifically designed to reduce or completely prevent contact or force on an occlusal surface, a dental appliance, or a lower support element. This design feature prevents direct contact between opposing occlusal surfaces or between an occlusal surface and a dental appliance such as a splint. This leads to a significant reduction in mechanical stress, particularly relevant for patients with bruxism. The device thus differs fundamentally from conventional occlusal splints, which primarily serve as buffers between the occlusal surfaces to reduce tooth wear.By preventing contact between the chewing surfaces, not only is abrasion and thus the introduction of microplastics into the body reduced, but the transmission of forces to the masticatory system is also minimized. This potentially leads to a significant reduction in stress on the teeth, periodontal structures, and temporomandibular joint, and a sustained reduction in damage caused by bruxism. The invention thus offers an innovative approach to the functional decoupling of the chewing surfaces and represents an advancement over known solutions. In one embodiment, the teeth of the upper jaw are 100% relieved of stress. Depending on the specific design of this embodiment, this can also apply to the teeth of the lower jaw – at a minimum, however, attachment to the palate allows for faster body awareness during sleep, thereby also reducing the force exerted.

[0040] Preferably, the spacer comprises a metal that prevents plastic deformation in at least one direction between the upper support element and the lower support element when force is exerted or movement is carried out by the mandible, in particular during a closing movement of the mandible or biting force.

[0041] The device according to this claim uses a spacer made of a metal material that prevents plastic deformation between the upper and lower support elements when subjected to force or movement by the mandible—particularly during a closing movement or when the teeth meet under biting force. Embodiments that do not deform plastically at the support elements are also possible. Crucially, the material used must be selected to prevent elastic deformation as much as possible and to return completely to its original shape after the force is released. This ensures that the device's function is permanently maintained without any permanent deformation or loss of its spacing effect.This property is particularly relevant under repeated stress, such as that caused by nighttime teeth grinding (bruxism), as it ensures lasting structural integrity and consistent protective effect. At the same time, the targeted use of metal allows for a reduction in material usage. It should be noted that, in principle, every material deforms slightly under force – including metals. However, the crucial factor is that the chosen structure is designed in such a way that any deformations remain so minimal that they have no functional impact and, in particular, the device's spacing function is never compromised. Even under repeated and intense force, such as that caused by bruxism, the defined distance between the support elements must not be significantly reduced, so that the device's protective effect remains permanently and reliably intact.Furthermore, the use of metal allows for more precise geometric guidance of the spacer, particularly in articulated or modular designs, as metallic components ensure defined movement limitations and greater dimensional stability under load. Preferably, the spacer is secured against unintentional dislodgement and / or asymmetrical positioning by an additional retaining element.

[0042] The device may include an additional retaining element that reliably secures the spacer against unintentional dislodgement and asymmetrical positioning. This retaining element may be an integral part of the spacer itself or, alternatively, located in the upper or lower support element, the retaining plate, or a combination of these components. This design feature ensures that the spacer remains in its intended position and fully performs its function, even under repeated stress or movement. In particular, the retaining element is intended to prevent injuries from the spacer and connected parts that could result from it leaving its intended position.The retaining element can be designed in a variety of ways, such as a nut, clamp, locking mechanism, bayonet fitting, snap connection, screw connection, magnetic connection, friction fit, or as a positive-locking guide with a stop. Combinations of these designs are also possible to achieve application-specific optimized fixation. Furthermore, the retaining element can be designed as a safety feature to prevent unintentional detachment or ingestion of components in the oral cavity. The chosen design contributes significantly to the operational reliability and longevity of the device, particularly under dynamic stress conditions such as those occurring in bruxism.

[0043] Preferably, the spacer has a change of direction between a lower end connected to the lower support element, in particular the retaining plate, and an upper end connected to the upper support element, wherein the spacer has a straight, curved, bent, and / or rounded profile in sections, particularly in the form of an angular, round, or semicircular line, for example, in an S-shape, U-shape, or Y-shape. The device is characterized in that the spacer has one or more targeted changes of direction. This change of direction can manifest itself as a straight, curved, bent, or rounded profile and can be designed, in particular, in the form of an angular, round, or semicircular line – for example, in an S-shape, U-shape, or Y-shape.The aim of this geometric design is to enable optimal adaptation of the spacer to the anatomical conditions of the oral cavity. Through targeted directional guidance, the spacer can be positioned so that, despite limited space, it acts securely and functionally between the support elements without creating pressure points or restricting freedom of movement in the mouth. The shape thus contributes significantly to the user acceptance, functionality, and biomechanical efficiency of the device. Preferably, the shape of the spacer will be straight near the upper support element to ensure, for example, sufficient freedom of movement in a ball joint and to enable movement in a uniaxial joint.In cases of medium to high palatal heights, the spacer is preferably curved upwards near the tongue to provide sufficient space and to offer structural reinforcement against the force exerted by the curve. This targeted design also optimizes material distribution and improves the cleanability of the device, as it prevents the formation of hard-to-reach corners or cavities. Preferably, the spacer runs parallel to the mounting plate and the lower support element, respectively, near the mounting plate and the lower support element. The upper support element is preferably perpendicular to the spacer to achieve an optimal center of pressure, which implicitly means that the spacer preferably changes direction in the middle.

[0044] Preferably, the spacer is oriented such that the upper support element rests against the palate behind the teeth, particularly between 1 mm and 20 mm from a chewing surface of the upper anterior teeth, and / or wherein the spacer extends upwards and preferably forwards at its upper end in the oral cavity. Within the scope of this application, the phrase "at its upper end" refers to a section comprising at least the uppermost 2 mm of material of the spacer, where "upper" describes the direction in which the spacer element extends towards the roof of the palate when properly positioned in the oral cavity.

[0045] The device according to this claim is characterized in that the spacer extends upwards and preferably forwards in the oral cavity at its upper end, so that the upper support element preferably rests against the palate, particularly behind the teeth, between 1 mm and 20 mm, more preferably 7 to 14 mm, measured from a chewing surface of the upper anterior teeth. This geometric orientation causes a controlled retraction of the mandible, thereby achieving a therapeutically desired positioning. Particularly in patients with bruxism or other functional disorders, this guidance of the spacer can relieve the temporomandibular joints and reduce harmful forces.The upward orientation also allows for more favorable force distribution into the upper support element, thereby reducing point loads and improving structural stability. Various configurations of the spacer are also conceivable, for example, exclusively upward, upward and backward, or predominantly upward and forward. The first two variants could be particularly advantageous in the treatment of snoring or obstructive sleep apnea, as they promote mandibular protrusion, which, according to current technology, can keep the airways open and thus improve symptoms. However, such posterior configurations generally require more material in the back of the mouth, which increases the risk of a gag reflex and can impair wearing comfort.The chosen upward and forward trajectory therefore represents a functional compromise for the majority of users, taking into account both therapeutic effectiveness and high acceptance in wearing.

[0046] Preferably, the spacer has at least two legs, each of which begins on and / or in the lower support element and / or on and / or in the retaining plate and converges from there. The device comprises a spacer with at least two legs, each of which begins on or in the lower support element, in particular the retaining plate, and converges from there. This multi-leg design serves to distribute mechanical loads during closing movements of the mandible and contributes to increasing the structural stability of the device. The multi-leg design also increases the torsional stability of the spacer and reduces the risk of tipping or twisting under asymmetrical loading. At the same time, it allows for a reduction in the amount of material used in order to optimally utilize the available space and minimize contact with the tongue and tongue displacement.In addition to two legs, variants with three or more legs are also conceivable, as is a design in the form of a complete, possibly elliptical, semicircle that, for example, follows the dental arch. Such geometries allow for even force distribution and anatomically adapted guidance of the spacer without compromising wearing comfort. This is particularly true for upwardly curved legs, which are especially suitable for users with sufficient palatal height. The starting point on the retention plate ensures that the base is particularly stable and makes deformation less likely. The starting point on the lower support element, just like on the retention plate, can allow for temporary or permanent attachment, so that the spacer remains securely in its intended position. This design represents a functional advancement compared to simple, single-axis spacers.

[0047] Preferably, the spacer runs in the oral cavity above the tongue and has a U-shape, for example, a U-shape when viewed from above with the open legs pointing towards the mouth opening and / or, viewed from the mouth opening, an inverted U-shape pointing upwards or a U-shape pointing downwards, and / or a Y-shape, for example with downward-pointing fork arms.

[0048] In one embodiment, the device is designed such that the spacer runs above the tongue and has a shape specifically optimized for wearing comfort and resistance to force. In a preferred embodiment, the spacer is U-shaped when viewed from above, with the open legs pointing towards the mouth opening. Other possible embodiments include an inverted U-shape pointing upwards from the mouth opening, which allows for a vertical orientation of the spacer and its connection to the upper support element. This geometry improves force absorption under vertical loads caused by mandibular movement. A Y-shaped design with downward-pointing fork arms is also conceivable to enable stable anchorage while simultaneously reducing material usage.

[0049] The preferred U-shape, with arms pointing towards the mouth opening, allows the spacer head to be positioned further back – for example, approximately 9 mm from the occlusal surface of an incisor – to place it behind the front teeth. This is particularly advantageous when flat anatomical structures or teeth in the front of the mouth prevent positioning there. This rearward placement also prevents the spacer from obstructing the tongue or triggering a gag reflex. Furthermore, the defined shape with multiple arms facilitates assembly and allows for modular connection with other functional elements, such as plug-in or screw connections at the arm ends.

[0050] Preferably, the spacer has a section extending towards the upper support element, wherein this section is designed in a U-shape and / or Y-shape starting from the base connecting the two legs.

[0051] The device preferably comprises a spacer which, in the region of the base of the U- or Y-shaped structure—that is, the connecting section between the lower legs—has a further section extending towards the upper support element. This additional section is designed to rise from the lower part of the spacer and connect to the upper support element. The course of this section can be straight, curved, or segmented, and preferably extends vertically or obliquely upwards.

[0052] The geometric design of this ascending section serves several functional purposes: Firstly, it enables a stable and force-transmitting connection between the lower part of the device and the upper support element, particularly under vertical loads from mandibular closing movements. Secondly, it allows the spacer to be positioned in the anterior oral cavity without interfering with the tongue or unnecessarily burdening the posterior oral space. By guiding the spacer along a defined curve, the device can be adapted to different anatomical conditions while simultaneously ensuring high mechanical stability and good wearing comfort. The additional section can also serve as a structural support for functional elements such as biofeedback components or sensors, especially if these are to be integrated into the upper support element.In alternative embodiments, the retaining plate, for example with a quarter-sphere surface or a comparable curved geometry, can also form the base for the legs or even replace the legs entirely.

[0053] Preferably, the spacer and / or the quarter-sphere surface, or a similarly curved geometry, is geometrically designed depending on the individual palatal height. For higher palatal heights, the spacer has a steeper slope, and the upper end may be extended accordingly to ensure a secure connection to the upper support element. For lower palatal heights, the base, for example, the U- or Y-shaped structure, may be flatter and run essentially parallel to the occlusal surfaces, providing only the minimum functional vertical height required towards the upper support element. In cases of very low palatal heights, it may be necessary to maintain the U- or Y-shape in plan view, while the legs are directed downwards in side view to provide sufficient space for the upper support element without requiring the mouth to open.However, this design can lead to a narrowing of the tongue space and reduce structural stability. Therefore, such a shape should preferably only be used when anatomical conditions absolutely require it, in order to ensure unrestricted functionality and high wearing comfort for as many users as possible. Preferably, the lower section of the spacer runs essentially parallel to the lower support element, pointing away from the teeth and into the interior of the oral cavity.

[0054] For example, in a single-axis joint design, the spacer runs parallel to the lower support element at least in its lower section and is oriented away from the teeth towards the inner oral cavity. This orientation is present at least in the lower section of a single-axis joint design. The orientation "away from the teeth" can also mean that the spacer, while located in the anterior oral cavity, may, for example, run towards the palate. This guidance, already described in previous sections, serves to position the spacer behind the incisors without interfering with the tongue, as well as to ensure a secure connection to the retention plate. In the case of a U-shaped or Y-shaped design, this construction should be used for relatively low palatal heights to create sufficient space for the upper support element.This orientation helps to position the device in the anterior oral cavity without restricting tongue freedom and allows for a stable connection to the retention plate even under dynamic load.

[0055] Preferably, at least one of the support elements, in particular both support elements, and / or the retaining plate is manufactured in one piece with the spacer.

[0056] One or two support elements and / or the retaining plate can be manufactured as a single unit with the spacer. This one-piece design can be implemented in several variations, each offering different functional and structural advantages.

[0057] In one embodiment, the spacer and the retaining plate are formed as a single piece, resulting in a closed circular, egg-shaped, or elliptical form, or a similar geometry, when viewed from above. In a U- or Y-shaped variant, the rear half of this structure—or the rear segment of the U-shape—rises upwards in the side view to keep the tongue space clear while simultaneously ensuring a stable connection to the upper support element. The one-piece design also allows for a single-axis joint. This one-piece construction reduces production costs by eliminating separate connecting elements and minimizes space requirements, as no additional components need to be considered. Furthermore, it reduces the risk of contamination at connection points, which is particularly important for hygiene in the oral cavity.The device's structural stability is increased by its single-piece design, thus reducing potential weak points and eliminating the risk of unintentional component separation. This is particularly advantageous under dynamic loads, such as those caused by chewing movements.

[0058] In other versions, the entire device can be manufactured as a single piece, for example without elastic components or joint structures. This has the advantage of very low production costs and easy cleaning.

[0059] Preferably, the spacer is temporarily or permanently connected to the mounting plate and / or one of the support elements, the connection being made in particular by screwing, plug connection or other mechanical coupling.

[0060] The spacer is connected to the mounting plate and / or one of the support elements, particularly the lower support element, either temporarily or permanently. A permanent connection ensures high mechanical stability and minimizes the risk of the spacer unintentionally loosening or falling off during use. Alternatively, the connection can be temporary to allow for replacement or adjustment of the spacer, for example, to accommodate different anatomical conditions or functional requirements, or as part of a modular design.

[0061] In addition to screw connections, other joining options are available, including, in particular, positive-locking plug connections, snap-fit ​​connections, clamping mechanisms, bayonet fittings, friction fits, adhesive bonds, and combinations of these techniques. The choice of connection depends on the desired reversibility, mechanical strength, ease of assembly, and the material properties of the components involved. The connection can be detachable or permanent, with detachable versions being preferred, especially for modular devices, while permanent versions offer increased safety and durability, particularly in applications with high mechanical stress.

[0062] Preferably, the spacer and one of the support elements together form a rotationally symmetrical joint structure, wherein either the spacer is designed as a cylindrical element and the support element as the associated receptacle, or the support element as a cylindrical element and the spacer as the associated receptacle.

[0063] In another embodiment, the spacer is designed as a rotationally symmetrical element, particularly in a cylindrical shape, and is permanently connected to the upper support element, for example, via a widening connecting piece. In this exemplary configuration as a single-axis joint, the lower support element or the retaining plate has a hinge-like design that allows for the articulated mounting of the spacer. This arrangement permits defined movement about an axis of rotation while simultaneously ensuring a stable connection between the spacer and the support elements. If a snap disc is used in this embodiment, a clearance of approximately 0.5 mm to 1 mm in the vertical direction (upwards and downwards) is preferably provided in addition to the snap disc height to allow functional movement without compromising structural integrity.

[0064] Alternatively, the spacer can also be designed as a rotationally symmetrical element, particularly in a cylindrical shape, and permanently connected to the lower support element, for example, via a widening connecting piece. In this configuration, the upper support element has a hinge-like design that allows for the spacer to be articulated. Here, too, if a snap disc is used within the joint structure, vertical play must be provided. This play allows for defined movement of the joint in the vertical direction without compromising the structural integrity of the connection.

[0065] Preferably, the retaining plate and / or the spacer are temporarily connected to one of the support elements in such a way that separation of the components is only possible outside the oral cavity, preferably only with the use of a tool. In a preferred embodiment, the retaining plate and / or the spacer are temporarily connected to one of the support elements, the connection being designed such that the components can only be separated from each other outside the oral cavity. This ensures functional safety during use and prevents unintentional detachment during application, particularly during chewing movements or other mechanical stresses in the oral cavity.

[0066] The connection can be made, for example, via snap-fit ​​mechanisms, concealed plug connections, positive locking mechanisms, or protected screw connections. Preferably, a tool is required for separation, such as a screwdriver or a release clip, which can only be used outside the oral cavity.

[0067] This design feature ensures that the device remains permanently stable in the oral cavity, while still maintaining a modular and maintenance-friendly design. Replacing or adjusting individual components – such as the spacer – is therefore possible without compromising safety during use.

[0068] Preferably the spacer (106) is positioned substantially perpendicular to a support element.

[0069] In a preferred embodiment, the spacer is essentially perpendicular to the lower support element and then extends via a change of direction - for example a bend or a kink - to the upper support element, which in turn is not necessarily arranged parallel to the lower support element.

[0070] The change in direction of the spacer makes it possible to bridge different spatial positions of the support elements, especially when the upper support element is offset or tilted in the oral cavity.

[0071] In current versions, the upper support element is positioned approximately 1 mm to 20 mm, preferably 7 to 14 mm, behind the teeth and has a slope of approximately 10–80 degrees, preferably 20–30 degrees, at this point. The spacer nevertheless meets the upper support element essentially perpendicularly, its geometry compensating for the non-parallel position of the two support elements.

[0072] In this embodiment, the spacer does not act as a spring, but rather as a rigid transmitter. To enable the additional function of a snap disc, a clearance of preferably approximately 0.5–1 mm is provided, allowing for a defined release upon application of force. The vertical arrangement of the spacer enables a compact design and direct force transmission along the vertical axis. This results in a stable connection between the support elements without unnecessarily stressing the tongue space.

[0073] Preferably, the spacer is designed in multiple parts, comprising an anchoring body with a fastening structure for anchoring in and / or on one of the support elements and / or in and / or on the retaining plate and / or in the spacer itself; an attachment part with a connecting profile that can be positively or non-positively attached to the anchoring body, for example a support surface and / or the retaining plate and / or in the spacer; and a connecting element for fixing the attachment part in the connecting profile of the support surface and / or the retaining plate and / or the spacer, such that by actuating the connecting element the attachment part is secured relative to the support surface in such a way that a force-transmitting connection is created, wherein the mechanism of action consists in the fact that by tightening the connecting element the attachment part is fixed to the anchoring body and held positively or non-positively on the attachment part.

[0074] In a preferred embodiment, the spacer, optionally including a screw connection associated with the spacer, is made up of multiple parts and comprises at least one anchoring body, an attachment part with a connecting profile, and a connecting element for fixing. The operating mechanism is based on the fact that tightening the connecting element—for example, a screw, a clamping mechanism, or a bayonet fitting—fixes the attachment part relative to the bearing surface or the anchoring body, creating a positive or non-positive connection. This connection can be either temporary or permanent. A temporary connection allows for the replacement or cleaning of individual components, and the connection is designed to enable repeatable assembly and disassembly without loss of function. In one embodiment, no tools are required for (dis)assembly.

[0075] A permanent connection increases structural stability and reduces the risk of unintentional loosening. A particular advantage of this precision-manufactured fastening structure lies in its hygienic design: the defined connection and tight fit of the components minimize the ingress of plaque or other contaminants into the fasteners. This significantly reduces cleaning effort and improves long-term compatibility—an aspect regularly highlighted as critical in practical applications. A tight fit of the components is also advantageous and intended for all other embodiments.

[0076] Preferably the device has a joint, for example a clamping joint, a clamping hinge, a cylindrical joint, a snap joint, an elastically preloaded bearing, a ball joint, a single-axis joint or a hinge, and the spacer is mounted on the upper or lower support element by means of the joint in such a way that there is at least one degree of freedom of movement between the support element and the spacer, preferably in the forward-backward direction.

[0077] The device can have a joint or hinge by which the spacer is movably connected to the upper or lower support element, allowing at least one degree of freedom of movement – ​​preferably in a forward-backward direction. This increases wearing comfort. During mandibular movements, the angle of the support element can adjust, preventing the upper support element in particular from pressing uncomfortably against the palate or causing localized pressure there. The joint-based, unidirectional movement also reduces stress on the temporomandibular joint and adjacent structures such as the hearing system, as it restricts movement in an undesirable direction. This one-dimensional movement also limits lateral mandibular movement, preventing disruptive and potentially damaging contact of the device with the posterior teeth and promoting muscular relief.

[0078] Preferably, the mounted arrangement of the spacer allows movement of the lower jaw relative to the upper jaw in the left-right direction and / or in the forward-backward direction.

[0079] This multidirectional mobility increases wearing comfort, as the device can flexibly adapt to the mandibular position during functional jaw movements. This design is particularly recommended for users who exhibit only minimal lateral mandibular movements or low stress on the hearing aid during a bruxism episode.

[0080] Preferably, the restriction of movement is achieved by a lateral narrowing and / or an extension of the socket downwards and / or by a more angular design of the socket and / or the spacer is shaped in such a way that the socket rests directly on the side of the spacer on which the movement is to be restricted, and / or by an individual adaptation of the upper support element.

[0081] There are various ways to reduce the movement of the spacer. Each of these options contributes to the targeted control of the degrees of freedom and allows for predictable restriction. A more angular design and direct contact of the spacer have the least impact on the overall construction. These mechanisms allow for precise adjustment of the permissible angles of movement and increase wearing comfort, especially for users with a low palate or those who exhibit only minimal lateral mandibular movements. Alternatively or additionally, the upper support element can be individually adapted to the shape of the palate or teeth, ensuring a stable fit – similar to a splint or a purely lingual dental rest. This results in the most precise positioning in the oral cavity and can also prevent the mandible from opening except under increased force.An extended glenoid cavity is particularly advantageous in cases of a high palate, as there is sufficient space available, and in cases of increased lateral pressure, which can, over time, increase the functional play due to potential material fatigue. Limiting movement in all directions can be beneficial, as the additional material makes the joint more stable and durable, preventing the supporting element from tilting excessively and thus no longer resting on the intended side.

[0082] Preferably, at least one support element and / or the spacer are formed or connected to each other by a hinge or joint, in particular a ball joint or single-axis joint, especially by a connection that is or can be produced under force or heating.

[0083] The hinge or joint can also be designed as an additional element, for example made entirely or partially of a different material than the spacer or a support element.

[0084] Preferably, at least one support element and / or the spacer are formed or connected to each other by a hinge or a joint, in particular a ball joint or single-axis joint, wherein the upper and / or lower support element is connected to the spacer formed as a joint, in particular by a connection that is or can be made under force or heating.

[0085] Preferably, the device comprises a socket joint formed in the support element, wherein the socket joint has an entry opening with a diameter smaller than the diameter of a spacer end piece formed in the spacer, in particular a ball, such that the spacer end piece can be snapped into the socket joint by applying force and / or heating the support element, and wherein the snap-in connection is designed to enable a joint function while simultaneously preventing unintentional release. The spacer end piece can alternatively have a different shape than a ball, e.g., an elliptical sphere or a cylinder. The device can have a socket joint formed in the support element whose entry opening is smaller than the diameter of the end piece formed in the spacer, so that the end piece can be snapped into the socket joint by applying force or heating.This requires suitable materials, such as a thermoplastic material for the joint socket. The end piece can be spherical. This design enables simple and precise assembly, reduces manufacturing effort, and allows for quick replacement of the spacer – both in case of fitting inaccuracies and during repairs. The defined snap-fit ​​connection maintains the joint function while simultaneously preventing unintentional loosening. Preferably, the joint socket is located in the upper support element.

[0086] Preferably, the socket joint has an elastically designed locking lip which temporarily deforms outwards when the spacer end piece, for example the ball, is inserted and springs back behind the spacer end piece, for example the ball, and locks into place.

[0087] This design facilitates assembly by qualified personnel or the user themselves, while simultaneously ensuring a secure, play-free connection. The locking lip thus supports the previously described integration of the ball joint or spacer end piece and contributes to reliable fixation without the need for additional fasteners.

[0088] Preferably, the socket joint has a conically recessed inner contour that provides a multi-point support for the spacer end piece, for example the ball, to increase the holding force.

[0089] The socket can be designed with a conically recessed inner contour, which allows for multi-point support of the spacer end, preferably the ball. This prevents the spacer end, preferably the ball, from resting only at a single point or on an edge, which could lead to blockages or uneven force transmission. The conical shape ensures even load distribution, increases the holding force, and improves the guidance of the spacer end, preferably the ball joint. At the same time, it contributes to more precise, stable, and durable movement under repeated loading.

[0090] Preferably, the joint socket has at least one gap, for example in the form of a semicircular ring segment, which is bounded by two spaced-apart circular arcs of the same curvature to increase the elasticity of the joint socket and to facilitate insertion and removal of the joint.

[0091] To increase its elasticity, the socket joint can be provided with one or more slots, for example, in the form of a semicircular ring segment with two spaced-apart arcs or in the form of a third of a circle. The slot should not run in the direction of pressure, as this increases the risk of the joint dislodging from the socket under force. The slot(s) facilitate the insertion and removal of the ball, as the socket can temporarily expand during insertion. Without such a slot, assembly is significantly more forceful or, in the worst case, could require more precise manufacturing tolerances or tools. At the same time, the connection remains stable and replaceable, which is advantageous both during initial assembly and for any subsequent replacement of the spacer.

[0092] Preferably the spacer end piece, preferably the ball of the ball joint, has a flattened zone that engages in a corresponding guide of the joint socket, so that the spacer end piece, preferably the ball, is rotatable only about one axis within the joint socket or the joint is designed as a single-axis joint or cardan or universal joint.

[0093] The device can be designed such that the spacer end piece, preferably the ball of a ball joint, has a flattened zone. This flattened zone engages in a corresponding guide within the joint socket. This positive-locking connection restricts the movement of the spacer end piece to a defined axis, so that the joint can only rotate about one axis. Alternatively, the joint can also be designed as a single-axis joint or as a universal joint. This design enables precise movement control, increases the stability of the connection, and prevents unwanted rotation or tilting of the spacer. Preferably, the joint socket also has a positive-locking rotational restraint that prevents the spacer end piece, preferably the ball, from rotating in at least one spatial direction.

[0094] The socket can be additionally equipped with a form-fitting rotational stop that prevents the ball from twisting in at least one direction. This design serves to selectively limit movement to specific directions—for example, to a purely forward-backward motion—thus enabling controlled guidance of the spacer. This can be useful to avoid unwanted lateral movements that could impair wearing comfort or lead to adverse stress on the palate or teeth. At the same time, the connection remains interchangeable, as the rotational stop does not fix the ball in place but only restricts its freedom of movement. This restriction of movement can be achieved through a flattened zone on the ball and / or a form-fitting rotational stop in the socket.Depending on the design, the positive locking rotational restraint can also secure the spacer end piece in the joint socket.

[0095] Preferably, the spacer comprises or consists of an inelastic material, in particular titanium, or an elastic, resilient and dimensionally stable material, in particular such that it deforms only slightly elastically under the forces occurring in use and returns to its original shape after being relieved.

[0096] Within the scope of this disclosure, "minor deformation based on the function of the spacer" refers to an elastic change in the shape of the spacer under service loads, which is so small that the function of the spacer is not significantly impaired. Significant impairment is defined as a force acting on the teeth that corresponds to the force acting on a commercially available occlusal splint. After the load is removed, the spacer returns completely to its original shape.

[0097] An “elastic, resilient, dimensionally stable material” within the meaning of this application is a material that can be reversibly deformed under mechanical stress, yet exhibits a defined dimensional stability. This means that under the forces occurring during use in the oral cavity (a maximum of 1,700 Newtons for most of the population, and a maximum of 300 Newtons in the anterior oral region for most of the population), the material yields only to a limited extent, a maximum of 4 millimeters, and returns to its original geometry after the stress is released, without permanent plastic deformation. Examples include certain engineering plastics or elastomers with high resilience.

[0098] A "minor deformation" within the meaning of this application refers to an elastic change in the shape of the spacer under service loads that is so small that the function of the spacer is not significantly impaired. Significant impairment is defined as a force acting on the teeth that corresponds to the force acting on a commercially available occlusal splint. After the load is removed, the spacer returns completely to its original shape. The geometric integrity and positioning function of the spacer are thereby maintained.

[0099] Preferably, the spacer has a Shore hardness of at least 50, determined according to Scale D, a modulus of elasticity of at least 700 MPa, determined according to ASTM D790, and / or a flexural strength of at least 2.0 MPa, determined according to ISO20795-2, wherein a material of the spacer is in particular based on methacrylates, for example KeySplint Soft Clear.

[0100] The device comprises a spacer whose material properties are specifically tailored to the requirements of its intended application. The spacer preferably has a Shore hardness of at least 50, determined according to scale D. This hardness specification ensures that the component possesses sufficient mechanical strength and dimensional stability to prevent yielding or permanent deformation even under sustained mechanical stress. A Shore hardness in this range particularly guarantees high resistance to compressive and shear forces, such as those typically encountered during use. Alternatively, Shore hardnesses above 60 or 70 can be used if increased strength and even lower deformability are required.

[0101] Furthermore, the spacer has a modulus of elasticity of preferably at least 700 MPa, determined according to the ASTM D790 standard. This material property describes the stiffness of the material used and allows for a reliable estimation of its behavior under bending stress. The selected minimum value ensures that the spacer maintains its geometry even under prolonged load and does not deflect undesirably. In alternative designs, the modulus of elasticity can even exceed 1000 MPa, further increasing the bending stiffness, which is particularly advantageous for applications with high continuous loads or for delicate structures.

[0102] In addition, the spacer is specified with a flexural strength of at least 2.0 MPa, determined according to ISO 20795-2. This value ensures that the component will not break or crack under bending moment loads. A higher flexural strength, for example in the range of 3.0 to 5.0 MPa, may be incorporated in future developments if the device is intended for use under dynamic or impact loads.

[0103] In this embodiment, the spacer material is based primarily on methacrylates. This class of materials is characterized by a combination of high dimensional stability, biocompatibility, and transparency. KeySplint Soft Clear, known for its combination of flexibility and high strength, can be used as a specific example. However, in addition to methacrylates, other materials can also be used, such as modified acrylic resins, epoxy resins, or high-strength polyurethanes, provided they meet the required mechanical properties.

[0104] As a further development, it is conceivable to equip the spacer with additional functional properties. It is conceivable to construct the spacer in multiple layers, with an inner layer exhibiting particularly high flexural strength, while an outer layer has a softer Shore hardness to achieve greater wearing comfort or better cushioning. Another embodiment could involve giving the material slight flexibility in a defined direction, for example, by integrating fiber reinforcements, thereby improving stability in one main direction while simultaneously allowing limited movement in another.

[0105] Preferably, the lower and / or upper support elements are multi-part. The multi-part design of the upper or lower support element can offer several functional advantages. Additionally, the multi-part nature of the support elements allows for tool-free disassembly or adjustment by the user, for example, through snap connections or flexible plug-in systems. This not only facilitates everyday handling but also allows for simpler and more cost-effective repairs and individual configuration of the device—for example, by exchanging individual modules with different degrees of hardness, surface textures, or additional functions. Modular adaptation to different jaw shapes or wearing requirements (e.g., in children or during orthodontic pretreatment) is also possible.Furthermore, the multi-part design can be used to selectively integrate elastic components, electronic components, sensors or other functional units into specific segments without having to remanufacture the entire device.

[0106] Multi-part construction can also simplify production, as certain geometries or functions—such as a click-in or slide-in protective housing for a snap disc—can only be realized through modular design. Furthermore, it can facilitate cleaning and, through additional covers between the parts, reduce the ingress of plaque or moisture. For example, additional covers for the metal parts can improve wearing comfort. Multi-part construction also allows for the integration of additional materials, such as metal components, to enhance rigidity and the spacer function.

[0107] Preferably, some or all of the points touching the body, especially the soft tissues, as well as the overall shape of the device, are smooth and rounded, particularly the surfaces adjacent to the tongue and / or palate (for example, without threads), and / or adapted to the shape of the palate and teeth of the user, in order to avoid injuries or pressure points.

[0108] This design significantly reduces discomfort and the risk of injury in the oral cavity, thus increasing the likelihood of long-term use. For particularly sensitive groups—such as children, the elderly, or people with sensitive mucous membranes—the smooth and rounded design can be crucial to the device's acceptance. Such surfaces can be produced through targeted post-processing (e.g., polishing) or through additive manufacturing processes with high surface quality to avoid unevenness or sharp edges from the outset.

[0109] Preferably, the device does not change the position of the tongue in its rest position, or only changes it slightly, to a maximum of 6 mm, for example by providing a cavity for the tongue.

[0110] The comfort of wearing the device is significantly influenced by how much the tongue has to deviate from its natural resting position. Ideally, the device does not alter this position at all or only minimally – preferably through a built-in cavity that provides the tongue with sufficient space. Instead of a simple cavity, the device can also have a concave or segmented shape that adapts better to the individual tongue contour and avoids concentrated pressure points. As a general rule, every additional millimeter reduces comfort more. A shift of more than 6 mm can lead to discomfort due to changes in tongue position, especially if the tongue is lifted, displaced laterally, constricted, or folded.The nature of the contact surfaces also plays a role: smooth, uniform surfaces are significantly more comfortable than technical structures like screws or threads, which exert pressure at specific points and can cause irritation. The surface texture is also important. A threaded surface, for example, is more bothersome than a smooth nail.

[0111] Preferably, the device has a mechanism for adjusting the width, for example a thread, a sliding mechanism, a spreading mechanism, an adaptable material, or an adjustment device such as an interchangeable part in different widths in a segmented design, so that the width of the device is adaptable.

[0112] The device can be equipped with a width adjustment mechanism to allow for individual adaptation to different mouth shapes. This can be achieved, for example, via a threaded connection, enabling precise and stepless adjustment without replacing components. Alternatively, a sliding mechanism can be provided, allowing for quick manual adjustment without tools. A spreading mechanism allows for targeted width expansion, for example, to adapt to asymmetrical dental arches. Furthermore, adaptable materials, such as thermoplastic components, can be used, which are malleable when heated, thus enabling flexible initial fitting. A segmented design with interchangeable parts in different widths allows for a modular device design.This not only simplifies manufacturing, but also cleaning, maintenance, and repair, as individual modules can be selectively replaced or modified. All of the aforementioned designs contribute to improved wearing comfort and simplified, precise individual customization of the device.

[0113] Preferably, the individual parts, in particular the spacer and / or the retaining plate and / or the upper support element, are designed to be interchangeable in order to adapt the device to different mouth shapes, in particular to different palatal heights or widths of the dental arch, whereby the interchangeability ensures a defined spacing and at the same time a closed mouth for all users.

[0114] The device is designed so that individual components, particularly the spacer, the retention plate, and / or the upper support element, are interchangeable. This allows the device to be flexibly adapted to different mouth shapes, especially varying palatal heights or dental arch widths. The interchangeability ensures optimal spacing for each user while simultaneously guaranteeing a closed mouth. A significant advantage of this design is that the device does not need to be completely remade if individual anatomical conditions change or if it is to be used by different users. Instead, only the affected components can be selectively replaced, simplifying the adaptation process, reducing costs, and increasing everyday usability.Particularly for patients with specific anatomical requirements or after dental procedures, this provides a precisely fitting and comfortable solution. Preferably, the device, especially the spacer and / or the upper support element, has a height adjustment mechanism, allowing the height of the device to be individually adjusted.

[0115] Height adjustment can be achieved, for example, through a scissor mechanism with a threaded spindle, an expansion device with a central screw, the insertion of spacers, or attachable and / or screw-on adjustment devices. This height adjustment allows the appliance to be optimally adapted to the individual anatomical conditions of the user. This increases wearing comfort and helps ensure that the user's mouth remains closed at rest. Simultaneously, the therapeutic effect is improved, as the distance between the upper and lower jaw can be adjusted so that the occlusal surfaces have little or no contact. Height adjustment also facilitates adjustment of the appliance in the event of changes in the oral situation, such as due to growth, without the need for a completely new appliance.It is also possible to raise or lower the height of the device on or on the lower support element.

[0116] Preferably, the height adjustment mechanism comprises a pair of lever arms pivotably connected at their ends, forming a variable support opening. The height adjustment is effected via a threaded spindle arranged on the lever arms, which is guided through threaded bores in the lever arms. A crank or rotary device is attached to the threaded spindle, which, by rotation, enables the lever arms to be moved apart and together by means of a scissor-like movement, thereby raising or lowering the upper end of the spacer relative to the lower end. The lever arms are each coupled at their center by a hinge joint to ensure a defined and stable movement.

[0117] This design allows the device's height to be individually and precisely adjusted to the user's anatomical needs. The scissor mechanism with threaded spindle enables stepless and stable adjustment, increasing wearing comfort and supporting optimal therapeutic effect. At the same time, it improves everyday usability, as the adjustment can be made easily and reproducibly.

[0118] Preferably, the device comprises an expansion apparatus, wherein a lower and an upper height adjustment element are moved away from each other by turning a central screw in order to enable height adjustment of the device, wherein the screw is preferably designed as a spindle with opposing thread sections.

[0119] This design allows the height of the device to be easily, precisely, and reproducibly adjusted to the individual anatomical conditions of the user. The expansion mechanism with counter-thread enables backlash-free and stable adjustment, which increases wearing comfort and supports optimal therapeutic effect. Adjustment can be made without special tools and is also possible retrospectively, for example, in the case of changes in the oral situation due to growth or dental procedures.

[0120] Preferably, at least one spacer washer is arranged between the spacer and a support element, which is designed to selectively increase the vertical distance between the spacer and the support element, and wherein the spacer, the spacer washers and the support element are connected to each other by means of a common connecting element, such as a screw, in a force-fit and / or form-fit and / or detachable manner.

[0121] By using spacers, the height of the appliance can be easily, flexibly, and reproducibly adjusted to different anatomical conditions, particularly varying palatal heights and / or dental arch widths. Assembly via a common connecting element allows for quick, secure, and repeatable adjustment or readjustment without having to replace the entire appliance. This increases wearing comfort, suitability for everyday use, and the therapeutic effectiveness of the appliance.

[0122] Preferably, the elastic component has at least one snap disc which, upon reaching a predetermined threshold of jaw movement and / or force from jaw movement, exhibits a distinct switching behavior and transitions from one state to another, and returns to its original state when a predetermined threshold is undershot.

[0123] This defined switching behavior of the snap disc provides clear and perceptible biofeedback for the user as soon as a predetermined jaw movement or force is exceeded. This enables reliable and reproducible feedback during bruxism events without the need for electronic components. The snap disc can generate acoustic and / or tactile signals (for example, a sound or vibration). This helps the user to recognize and reduce unconscious jaw activity, possibly in conjunction with a smartphone application that amplifies the effect. Simultaneously, the resetting mechanism ensures that the device returns to its initial state after the event and is ready for further events.The signal(s) can be evaluated, for example, via a smartphone, and an alarm triggered within a smartphone application for a bruxism event (e.g., in the form of vibration, light, or sound) can be started and stopped. The solution is robust and requires little maintenance.

[0124] Preferably, the snap disc is arranged in the upper and / or lower support element, in particular in the upper support element.

[0125] The placement of the snap disc in the upper and / or lower support element offers several advantages: It enables a particularly effective transmission of the forces generated by jaw movement directly to the snap disc, thus reliably triggering biofeedback. Integration into the support element protects the snap disc from moisture and mechanical damage in the oral cavity, increasing its lifespan and operational reliability. In particular, its placement in the upper support element ensures that the acoustic or tactile signal (e.g., a "click") is easily perceptible to the user, providing immediate feedback. The design remains compact and comfortable, as no additional components are required in the oral cavity.Preferably, the spacer has a contact surface at its end facing the snap disc, for example a pin, a ball joint, a universal joint or a single-axis joint, through which the snap disc is deformed and released by a pressure exerted by the contact surface, wherein the contact surface preferably has a maximum area of ​​2000 mm. 2 , especially preferably less than 1 mm 2 is and is preferably flat, rounded and / or conical in shape.

[0126] Snap discs are typically made of thin, prestressed metal (e.g., stainless steel or titanium) and are shaped to suddenly flip when a specific force is applied. This switching behavior is most reliable when the force is applied in a targeted and defined manner. Therefore, in practice, snap discs are often triggered by small, centrally located contact surfaces—such as a pin or a small dome. This localized load ensures that the snap disc collapses precisely at its intended center point, generating clear tactile or audible feedback. Using a small, precisely shaped contact surface on the spacer offers several advantages: (1) Reliable triggering: The localized force application ensures that the snap disc triggers reliably and precisely when the defined threshold is reached.(2) Prevention of malfunctions: An excessively large or extensive contact area could subject the snap disc to uneven stress and lead to unintended or failed activation. (3) Protection of the snap disc: The defined contact area reduces the risk of material fatigue or permanent deformation, as the load is applied in a targeted and controlled manner. (4) Compact design: The joint or pin design allows for a space-saving construction that integrates well into intraoral devices. The same applies to integration into a single-axis joint, which thus performs two functions simultaneously – spatial movement and activation of the snap disc.

[0127] Preferably, the contact surface of the spacer is arranged within a ring that prevents it from sliding out and / or has a clearance of 0.2 to 1.5 mm, preferably 1 mm, up to the snap disc to allow the snap disc to return to its original state. This defined clearance between the contact surface and the snap disc is technically advantageous because it supports the reliable function of the snap mechanism. If the snap disc is triggered by a jaw movement, it must return to its initial position after the event in order to be able to trigger again for subsequent events. If the clearance is too small, the contact surface can hinder or block the return movement, which can lead to malfunctions, increased material fatigue, or even biofeedback failure.The clearance of 0.2–1.5 mm, preferably 0.5–1 mm, ensures that the snap disc is not permanently under tension, but can switch freely and repeatably between states. The required clearance results from (1) the height of the selected snap disc, for example, 0.2 mm, (2) the goal of minimizing the overall design height of the device and the overall clearance, especially for users with a low palate, and (3) the manufacturing tolerances of the material used. Current manufacturing tolerances for 3D printing are approximately 0.8 mm. With advancing manufacturing technologies, the required clearance can be reduced in the future. This increases the device's lifespan, provides consistent feedback (e.g., tactile or acoustic), and minimizes the risk of jamming or unintentional continuous contact.Overall, this design contributes significantly to the reliability, low maintenance and suitability for everyday use of the device.

[0128] Preferably, the elastic component is housed in a protective casing.

[0129] Preferably, the upper and / or lower support element and / or the spacer is designed as a protective housing that encloses a component arranged therein.

[0130] The device can be designed such that the upper or lower support element or the spacer simultaneously functions as an integrated protective housing. This integration saves installation space, as no separate housing is required, for example, for a snap disc, and increases the structural stability of the protective housing. At the same time, an elastic component, for example, is reliably shielded and secured, preventing accidental release or ingestion. Simultaneously, the user is protected from direct contact with the component. Preferably, the snap disc is configured in multiple versions to increase the intensity of the generated biofeedback, with the double version being designed to respond to relative movements between the upper and lower jaw from both directions.

[0131] The device is designed to have one or more snap discs, with a double or triple configuration being particularly suitable. This double or triple configuration serves to increase the intensity of the generated biofeedback. This is especially relevant when the acoustic feedback is recorded by an external device, such as a smartphone, and a higher feedback volume can be generated via the multiple configurations. Accordingly, the snap disc's sound should be loud enough to be perceived or recorded outside the oral cavity in the same room.

[0132] The redundant arrangement of two snap discs increases the force required for triggering. This means that the snap disc does not activate with minor movements or slight forces, but only at a higher threshold, thus reducing false alarms.

[0133] The forces acting within the oral cavity can be significantly higher than the trigger force of a single snap disc, which is determined by the size of the oral cavity and the number of trigger cycles. The multiple snap discs prevent unintentional triggering, thus significantly improving wearing comfort and increasing the device's acceptance in everyday life.

[0134] Furthermore, the multiple versions can be designed in such a way that they become more perceptible even when moving into a state without force, thereby further increasing the effectiveness of the biofeedback and facilitating the collection of bruxism measurements by external devices such as a smartphone.

[0135] An additional advantage of the multiple design lies in its reliability: Should one of the snap discs be damaged or malfunctioning, the feedback function of the device remains intact. This increases the reliability and service life of the device in practical use. Preferably, the support element containing the snap disc has openings, the openings being designed so that this support element can be cleaned with a toothbrush, the toothbrush preferably being able to be inserted through the openings from several sides so that all relevant inner surfaces of the support element are accessible.

[0136] The device comprises a support element, which, for example, contains a snap disc and is provided with openings that allow mechanical cleaning with a toothbrush. The openings are designed so that the toothbrush can preferably be inserted from several sides, thereby allowing all internal surfaces of the support element to be reached and cleaned.

[0137] This design improves hygiene by reducing plaque buildup and the accumulation of saliva or other biological residue. Accessibility from multiple sides eliminates hard-to-reach areas that could otherwise lead to microbial contamination or unpleasant odors. Regular cleaning also protects the functionality of the snap disc by preventing mechanical blockages or deposits that could impair its return action or release mechanism.

[0138] Another advantage is that the device does not need to be disassembled or opened for cleaning. Cleaning can be carried out while installed, which simplifies handling and eliminates the risk of incorrect repositioning after cleaning. This increases the device's everyday usability and safety, especially with regular use.

[0139] The openings can also serve as through-holes, for example, to improve saliva flow or to accommodate adjustment devices. They thus contribute not only to hygiene but also to functional expandability and weight reduction of the device. Overall, this design creates a durable, user-friendly, and hygienically optimized solution that particularly meets the requirements of an intraoral device for the treatment of bruxism. In one aspect, a device for the treatment and / or prevention and / or testing of bruxism is proposed, designed to be positioned in the oral cavity, preferably between the upper and lower jaws, of a user.The device comprises: an upper support element configured to contact a portion of the maxilla other than an upper occlusal surface; a lower support element configured to contact a portion of the mandible other than a lower occlusal surface; and a spacer connecting the upper and lower support elements. The device is designed to keep a substantial portion of the oral cavity between the mandible and maxilla free of material and to substantially reduce or prevent the exertion of a contact force on the upper and / or lower occlusal surfaces, and in particular to hold the device in its intended position.

[0140] The device according to the invention can also be used without problems by users with one or more missing teeth, sensitive teeth, severely irregular tooth positions, implants, partial or complete dentures, periodontal disease, or active dental treatment (for example, braces with teeth that change position over time or recently performed dental restorations such as crowns or bridges), at least in the upper jaw, which sets it apart from the prior art. It prevents noise caused by bruxism. A positive effect on temporomandibular joint disorders (TMD) is possible.

[0141] The device reduces damage and pain caused by bruxism, thus improving the state of the art. The spacer ensures that the chewing surfaces do not touch, or at least not significantly. The slight opening of the bite caused by the spacer leads to an anatomically determined reduction in biting force due to poorer leverage, unstable joint position, reduced neuromuscular control, and a more stretched muscle position.

[0142] In some designs, placement at the front of the mouth behind the incisors reduces the biting force by up to 75% for anatomical reasons (around 200 Newtons in the front teeth and 800 Newtons in the back teeth), thus further reducing potential damage. Furthermore, the already reduced biting force no longer acts on the chewing surfaces and underlying body parts, but rather on the contact surfaces of the device and thus on the soft tissues, which, unlike the teeth, at least partially absorb and transmit the biting force to the user. Positioning the device in the oral cavity also reduces lateral jaw movement, which can particularly alleviate tinnitus and muscle pain. Minimal material usage reduces discomfort in the mouth and increases wearing comfort.

[0143] The intended placement of the device dictates its height and shape. For example, the device is lowest in the retromolar space due to its proximity to the temporomandibular joint, at a medium height in the oral cavity, and highest in the vestibule. Its shape is adapted to the surrounding tissue, which is why the device resembles a round rod in the retromolar space, has a shallow depth but a large width in the vestibule between the teeth and cheeks, and follows the palate in a curved line at the top and the tongue and floor of the mouth almost vertically at the bottom. Some designs incorporate a groove for the tongue to increase wearing comfort.

[0144] The support elements and the spacer not only separate the occlusal surfaces but also hold the device in the intended position. While only minimal positional changes are possible when positioned in the retromolar region and the oral vestibule due to the shape of the device and the surrounding body parts, in a preferred embodiment for positioning in the oral cavity, the device is arranged around the tongue, since positioning on the tongue results in insufficient positional stability.

[0145] Preferably, with the exception of the height, the device is designed to be movable by a few millimeters through a suitable wall thickness and appropriate material in order to increase wearing comfort.

[0146] The force generated by mandibular movement during a bruxism event, combined with the device's attachment to soft tissue, can produce biofeedback in the form of discomfort for the user, which is not possible with splints. Furthermore, because the device is attached to soft tissue, there is no fixed stop point like with occlusal surfaces or a splint, as the device, when force is applied, first compresses or displaces the soft tissue.

[0147] This, combined with the reduced force exerted by the slight jaw opening and the biofeedback from attaching the device to the soft tissues, reduces the likelihood of developing jaw misalignment, both compared to a splint and compared to untreated bruxism, which can lead to jaw misalignment. The spacer can be positioned to achieve a slight retrusion.

[0148] Preferably, the device has a central support element designed to rest on the tongue and to distribute the biting force generated by the movement of the lower jaw between the floor of the mouth via the lower support element and the tongue via the central support element.

[0149] Chewing surfaces are largely insensitive to force (especially during sleep), which is why bruxism often goes unnoticed. In comparison, the palate and the upper part of the tongue are sensitive, and the floor of the mouth is even more sensitive to force. To increase wearing comfort, it is therefore advisable to distribute the downward biting force not only onto the floor of the mouth but also between the floor of the mouth and the tongue. This helps to reduce or prevent irritations and small wounds on the floor of the mouth, as well as pain when wearing the mouthpiece. Accordingly, the middle support element is positioned on the tongue and below the upper support element in such a way that it directs a portion, preferably a larger portion, of the downward force generated by the mandibular movement onto the tongue.It can lie horizontally, at an angle, or be slightly curved on the tongue, and may be shaped like a sphere, hemisphere, or arc. Its surface preferably extends over the greater part of the tongue's width and a portion of its length to distribute the biting force over a larger area.

[0150] Preferably, the device is dimensioned so that the user's mouth can remain closed.

[0151] If the device is too large for its placement, the user will be unable to close their mouth. Sleeping with an open mouth can lead to poorer sleep, dry mucous membranes, and an increased risk of infection (sore throat, bad breath, tooth decay, and gum disease). Since the height of the oral cavity, and therefore the required spacer or device height, can vary significantly between users, individualization or different height options are advisable. The optimal height depends not only on individual body structure and placement but also on the size of the contact area(s) on the soft tissue. With a smaller contact area, the device sinks deeper into the soft tissue. The smaller the size, the stronger the biofeedback, which can become unpleasant or even painful if the device is too small.

[0152] Preferably, the device is designed to hold the tongue and, in particular in the usage position, lies at least partially below or above or at the tip of the tongue and / or laterally, preferably on the shape side, against the user's tongue, preferably pressing against the tongue.

[0153] If the tongue is touched or enclosed on at least one side by the tongue holder, both tongue slippage and the slippage and involuntary removal of the device are prevented even more effectively. In a preferred configuration, the tongue holder exerts pressure on the tongue.

[0154] According to this claim, the tongue support fits snugly against the tongue to prevent slippage, yet is not so tight as to cause permanent tongue deformation. In one embodiment, the device is attached under the tongue, for example, in the form of an open ellipse encompassing the tongue and / or in the form of two laterally parallel rails. In this case, a complete, full-length construction is not required; for example, the rails do not need to be attached along the entire length of the tongue, nor does the elliptical shape need to be continuously covered with material. In a preferred embodiment, the device is attached to two or more opposite sides of the tongue. A non-smooth surface texture on the tongue support can further improve its grip. The tongue support can be adjusted to the user's anatomy to increase wearing comfort.Preferably, the device has at least one cavity designed to hold the tongue. In particular, the upper and / or the lower support element and / or the middle support element and / or the spacer are configured to receive the user's tongue in the cavity between the upper and / or the lower support element and / or the middle support element and / or the spacer in the operating position.

[0155] The cavity increases wearing comfort, as the tongue can largely remain in its resting position. At the same time, it further strengthens the fixation of the tongue and the device against slippage. The cavity also improves the fixation of the device in the oral cavity. Positioning without a cavity, i.e., solely on the tongue, has the further disadvantage that the device is not held laterally and / or is held by the teeth rather than the soft tissues, which creates a risk of tooth displacement and a high risk of the device being dislodged (possibly even out of the oral cavity). In a preferred embodiment, the cavity is arranged between the middle support element (and, if this is not present, the upper support element) and the lower support element, with the spacer encompassing the cavity laterally.

[0156] Preferably, the device encloses the tongue in the basic shape of a ring or an ellipse, in particular an open ring or an open ellipse, once or several times.

[0157] The basic shape of a ring or ellipse, possibly in multiple forms, further reinforces the fixation of the tongue and the device against slippage. The ring or ellipse can be completely closed, though it does not necessarily encompass the entire tongue; a portion can also serve as an upper support element or retaining plate. The ring can also be open at several points. An open ring or ellipse increases wearing comfort without significantly reducing the fixation of the tongue and device. Preferably, the side that comes into contact with the soft tissue, including the tongue, is rounded, similar to a ring.

[0158] The ring or ellipse can also be elongated along the tongue, thus approximating the shape of a tube as a very wide ring. The ring can also close at the front, resulting in a hemispherical surface if it is a closed ring. An open ring might, for example, have a quarter-sphere surface, and an open ellipse a quarter-dome elliptical surface.

[0159] Multiple rings are also possible and, like a very wide ring, increase the stability of the device. Preferably, the design allows the ring or ellipse to expand slightly, for example, through appropriate material thickness and choice. Even parts attached only on one side with wall thicknesses of just a few millimeters allow for minimal movement.

[0160] Preferably, the spacer and / or the lower support element is designed to fix the tongue in the oral cavity in the position of use, in the manner of a vise, on at least two opposite sides, preferably left and right, once or several times, with a minimally movable design being preferred.

[0161] The clamping action, similar to a vise, further reinforces the fixation of the tongue and the device, preventing slippage. Additionally, during a bruxism episode, some of the biting force generated by the mandibular movement is transferred to the tongue, increasing wearing comfort and potentially reducing biting pressure on the teeth. The fixation can be applied on the left and right, top and bottom, on three sides, or on all sides, and the fixing material does not need to be continuous across the entire device.

[0162] With a design featuring fewer than four sides, the risk of the retaining device being too tight (and therefore painful) or too loose (and therefore ineffective) is reduced. Preferably, the shape is smooth and free of sharp corners to enhance wearing comfort. Preferably, the vise-like design allows minimal movement (on the order of 0.1–3 mm, preferably 1–2 mm) to further improve comfort and give the user more flexibility in choosing where to attach the device to the tongue. This can be achieved, for example, by adjusting the wall thickness and / or by using jaws that are attached at only one point. Preferably, the device has two inverted U-shapes visible from the front and back, and two upright U-shapes visible from the left and right.

[0163] The two inverted U-shapes follow the natural contours of the tongue and palate, thus accommodating the tongue without altering its position or touching the palate without causing irritation or pain. The two upright U-shapes, positioned to the left and right between the tongue and teeth, touch the tongue, utilizing the space between the sides of the tongue and teeth, and simultaneously serve as a tongue rest. Preferably, the device exerts no force on the teeth that alters their position; furthermore, preferably, the device does not touch the teeth.

[0164] The U-shaped design ensures the device stays in place within the mouth. Ideally, not only the overall shape but also the individual components are rounded. The wall thickness must be considered, as both excessively thick and excessively thin walls can lead to discomfort. The absence of sharp corners and edges prevents irritation and optimizes wearing comfort.

[0165] In another embodiment, the device has only an inverted U-shape, as this also ensures the secure positioning of the spacer and the tongue. In yet another embodiment, at least one inverted U-shape is extended in the direction of the tongue. In a further embodiment, at least one additional part can be attached to the upper side of the two inverted U-shapes.

[0166] Preferably, the legs of the inverted U-shapes are connected to each other at the bottom or form the lower support element.

[0167] This design saves material and reduces weight, as the lower and upper support elements and spacers require no additional connecting pieces. Preferably, the design consists only of rounded shapes. This overall increases wearing comfort. Preferably, the middle support element is positioned between the legs of the inverted U-shape; more preferably, the middle support element is integrated as part of the tongue support.

[0168] For users with a shallow oral cavity, at least one of the inverted U-shaped supports can simultaneously form the central support surface for the tongue, thus relieving the floor of the mouth from the force generated by the relative movement of the upper and lower jaw. In this case, no additional central support element is necessary, as the upper support element holds the tongue downwards and ensures the necessary distance upwards.

[0169] For users with a higher oral cavity, an additional central support element is required to redirect the force generated by the relative movement of the upper and lower jaw from above onto the tongue, thus relieving the floor of the mouth of this force and simultaneously maintaining a distance between the occlusal surfaces. This can be achieved, for example, by attaching an additional inverted U-shape to one or both of the existing inverted U-shapes to keep the occlusal surfaces separated.

[0170] Alternatively, the central support element can be positioned between the legs of the inverted U-shape, as the tongue also lies between them in this configuration. The central support element can also be positioned horizontally and straight. Preferably, the central support element has no corners or edges. It should be noted that the height of the oral cavity can be influenced by the flexibility of the floor of the mouth or other soft tissues, which may or may not yield significantly; therefore, the height must be determined under pressure. The central support element, like the other support elements, can be straight, angled, or rounded in all directions.

[0171] Preferably, the spacer is essentially perpendicular to both the upper support element and the lower support element.

[0172] A (nearly) vertical position offers the greatest stability in the fixation during a bruxism event, as the device cannot slip sideways due to mandibular movement, but on the contrary, is even more firmly fixed in its position. The spacer rests at a 90-degree angle on the upper and lower support elements, preferably at a 60 to 120-degree angle, which, within the scope of this disclosure, is understood as essentially or nearly vertical.

[0173] Preferably, the spacer and / or the device is left-right symmetrical.

[0174] Symmetry is necessary to prevent lateral misalignment in the oral cavity and, for example, to avoid uneven stress distribution or tilting of the device. Lateral misalignment and / or non-left-right symmetrical positioning of either the spacer alone (with or without force) or the entire device leads to a reduced wearing comfort and can cause the device to shift teeth. It is also possible that the device may unintentionally move between the occlusal surfaces, acting like an ill-fitting splint and altering the occlusion. Furthermore, an asymmetrical design can lead to muscular imbalances in the masticatory system and promote the development or exacerbation of craniomandibular dysfunction (CMD).The left-right symmetrical design of the device is fundamentally relevant for wearing comfort, especially for the parts that contact the body. It is particularly relevant for device designs that are not customized to the individual user. Furthermore, the symmetrical design facilitates the production of standardized size variants and reduces the effort required for customization during manufacturing.

[0175] Preferably, the upper support element and lower support element are designed in such a way that the device can be placed in the retromolar space or outside the actual oral cavity (Cavum oris proprium).

[0176] Placement in the retromolar region allows for a cost-effective design using minimal material while minimizing the risk of accidental mispositioning or displacement of the device. Placement outside the oral cavity leaves the oral cavity unaffected and offers users with specific medical conditions (such as oral cancer) the option of using the device nonetheless. Both placement sites allow sensitive users to alternate between placing the device outside and inside the oral cavity in various configurations to avoid or alleviate irritation and pain. One possible design for the retromolar space features a cylindrical shape with end pieces rotated approximately 90 degrees for attachment to the gums.

[0177] One possible design for attachment in the oral vestibule is approximately lemniscate-shaped to protect the labial frenula from the force generated by mandibular movement. Another design for placement in the oral vestibule involves two semicircular spacers positioned near the temporomandibular joint and connected to each other.

[0178] Preferably, the upper support element is designed to be received in the palate and the lower support element is designed to be received in the floor of the mouth.

[0179] When the contact elements follow the shape of the palate and the floor of the mouth, wearing comfort is increased, and the device is simultaneously held in its intended position. This is particularly important for the frenulum, which can otherwise become painful and / or even damaged. Preferably, the upper and lower contact surfaces are shaped and thickened to reduce or eliminate any cutting sensation during a bruxism episode, i.e., at least without any sharp corners or edges.

[0180] In one embodiment, the upper support element can be curved downwards in one or more directions to follow the contours of the palate. In preferred embodiments, the lower support element can assume the U-shape already described or an elliptical shape. For example, it can also be attached to the floor of the mouth as a U-shaped plate (with the legs pointing towards the pharynx), with its outer edges curved upwards in one or more directions. It is also possible to have only parts of the plate made of a specific material (for example, with holes to improve saliva flow or as described in the following preferred embodiment).

[0181] Preferably, the device has two spatially wound structures that are connected directly or indirectly at their small radii, while their large radii are spaced apart facing each other, wherein the structure in particular in the area of ​​the small radii forms the middle and upper support element, and the structure in the area of ​​the large radii forms the lower support element.

[0182] The shape allows for a cost-effective construction with minimal material usage while maintaining high wearing comfort, as the shape has no sharp corners. The small radii can also form the central contact surface. In one embodiment, the large radii can additionally secure the device in the sublingual area at their front end pieces. The two spatially coiled structures must be connected to each other at least at one point, either at the two mouth-facing end pieces of the large radii or at the small radius. In a preferred embodiment, the two mouth-facing end pieces of the large radii are not connected to each other, thus making the tongue support more flexible.

[0183] Preferably, single or multiple through holes are provided along the structures of the device.

[0184] The primary function of through-holes is to prepare the device for adjustment devices, allowing the user to attach these devices at suitable locations and thus increase or decrease comfort. Through-holes can also improve saliva flow. If the device is of an unfavorable shape and size that could obstruct the pharynx (for example, in the form of a hemisphere or sphere), through-holes can eliminate the risk of suffocation.

[0185] Preferably, the device has a biofeedback mechanism, wherein the biofeedback mechanism provides feedback to the user via one or more human senses in the event of a mandibular movement and / or force applied as a result of a mandibular movement.

[0186] The behavioral changes triggered by biofeedback can reduce the duration, frequency, and intensity of bruxism. The trigger, via mandibular movement or the force generated by this movement, ensures that a bruxism event is present. Biofeedback also allows for testing the user for bruxism; the rule is: if the user receives no biofeedback, they do not have bruxism. Human senses include sight, hearing, smell, taste, touch, pain (nociception), kinesthetics (perception of body movement and position), and proprioception (the sense of one's own body position and movement). Accordingly, biofeedback can include, for example, directly or indirectly generated acoustic, tactile, olfactory, gustatory, visual, or electrical biofeedback.

[0187] Preferably, the biofeedback mechanism comprises an elastic component, the elastic component being designed such that, upon reaching a predetermined threshold of mandibular movement or the force generated by a mandibular movement, it exhibits a distinct switching behavior and transitions from one state to another. The threshold can be determined by simulation or experimental tests.

[0188] A single elastic component is sufficient to generate the biofeedback; that is, no electrical or electronic components are needed, which would consume space, increase costs, and raise the risk of repairs. The threshold ensures that the user is not alerted to false alarms where no bruxism event has occurred despite the alarm being triggered. Additionally, the mandibular movement, or rather the force generated by this movement, is used, which largely eliminates false alarms. The elastic component can be designed, for example, as a snap disc or a piezoelectric element.

[0189] Preferably, the elastic component has at least one snap disc.

[0190] A snap disc can be attached to the palate, for example, below or above the upper support element, within the upper support element, or, in the case of multi-part devices, between the upper support elements. It can also be attached, for example, above the tongue or in or to the lower support element. It must be fixed to the device at least at one point. The angle of the snap disc can be, for example, horizontal, but also rising forward (i.e., with the highest part near the mouth) or rising backward (i.e., with the highest part near the pharynx). In a preferred embodiment, the corners and edges of the snap disc are rounded and / or encased in a non-metallic material to increase wearing comfort, and / or it is ensured that the body does not touch the snap disc.

[0191] The snap disc can be, for example, round or square, possibly with support feet, or elongated and curved along its length. A snap disc is a simple, standardized, mass-produced, and cost-effective solution for generating biofeedback.

[0192] Preferably, the snap disc is designed to generate acoustic and / or tactile feedback when it is deformed by a force generated by a mandibular movement and / or a relative movement between the upper and lower jaw, or when it returns to its original state.

[0193] Depending on the chosen size, shape, and material thickness, the snap disc can exhibit a different trigger force, offering the possibility, but not the necessity, of customization. Although a human theoretically possesses a bite force of 80 kg per centimeter, or up to 1700 Newtons in total, the force required to trigger the snap disc in the device is significantly lower. Since smaller snap discs generally produce lower noise levels than larger ones, and very small snap discs generally only vibrate, this allows for designs with both sound and vibration, as well as designs with vibration only.

[0194] The latter, or only very quiet noises, have the advantage that people sleeping in the same room as the user are not disturbed by noise, and the user themselves is not affected by noises in the immediate vicinity of the eardrum. At the same time, it allows the use of smaller, and therefore space- and material-saving, snap discs.

[0195] Even when using a snap disc, the movement of the lower jaw acts on the snap disc, thereby preventing any force from being exerted on the occlusal surfaces, thanks to the spacer. Preferably, the snap disc is deformed by pressure exerted by a pin.

[0196] The deformation of the snap disc by a pin has several advantages: The snap disc can be less perpendicular to the direction of force, since the pin can compensate for this to a certain extent by being attached at its own angle.

[0197] Indirect pressure generation via the pin also allows for a reduction in the force exerted by mandibular movement or for a change in the trigger point (for example, via a spring mechanism on the pin). This increases durability. The snap disc can also trigger with greater reliability, as the pin strikes it in the center.

[0198] The pin preferably has a cylindrical or spherical shape, i.e., at the point where the pin touches the snap disc, it is preferably flat or round.

[0199] Preferably, the elastic component is housed in a protective casing.

[0200] A protective housing allows the elastic component to be fixed in place, minimizing slippage within the device and reducing the risk of detachment and thus the ingestion of small parts. The protective housing can prevent the body from coming into direct contact with the elastic component (which may be made of metal, for example), reducing the risk of injury and improving comfort. Furthermore, the protective housing can enclose the elastic component in such a way that any existing snapping effect is either enhanced or reduced (for example, by altering its curvature).

[0201] The protective housing follows the shape of the elastic component and is therefore preferably angular and / or rounded (for example, in the case of rounded corners of the snap disc) and the same size as the elastic component (possibly slightly larger to compensate for production tolerances). The protective housing must only contact the elastic component to such an extent that any intended change of state of the elastic component can be easily achieved. Preferably, the elastic component is only attached to the protective housing by its form. However, the elastic component can also be attached to the protective housing by means of adhesive bonding, riveting, ultrasonic or induction welding, overmolding, clips, or screws. Preferably, the elastic component is arranged in a protective housing made of a moisture- and pressure-resistant material. It can also be completely embedded.

[0202] Preferably, the snap disc is designed to react to the relative movement of the upper and lower jaw from both directions, and in particular, the snap disc is designed in double form.

[0203] Conventional snap discs only produce a sound and / or vibration when moved in one direction. Since, from the relative perspective of the device, the biting force or jaw movement can originate from both above and below (food is also ground by both chewing surfaces, even though only the lower jaw changes position), the possibility of triggering from above and below is desirable.

[0204] This can be achieved, for example, by arranging a second snap disc in the device rotated 180 degrees around the horizontal axis relative to the first. Additionally, the arrangement of two snap discs delays the triggering moment or increases the required force, which can reduce false alarms.

[0205] Preferably, the biofeedback mechanism includes a piezoelectric element, which is preferably designed both as a sensor for a bruxism event and / or as a source for biofeedback and / or as an energy source.

[0206] Bruxism generates kinetic energy in the oral cavity, specifically from the moment it begins and causes, or can cause, damage, and should therefore be prevented. The piezoelectric element makes this kinetic energy usable for the device.

[0207] The piezoelectric element can perform various functions: In the event of bruxism, it acts as a sensor. Due to the force required before or for energy generation, this sensor has an implicit threshold and thus prevents false alarms from slight and therefore non-damaging jaw movements.

[0208] The energy generated by the piezoelectric element when the threshold is exceeded can also be used to operate electrical devices, for example for data communication and transmission.

[0209] Alternatively or additionally, the generated energy can be used to produce biofeedback. The piezoelectric element can itself become a source of biofeedback via the current transmitted to the body (possibly attenuated by a resistor).

[0210] Preferably, the piezoelectric element is enclosed in a protective housing so that it remains permanently functional in the moist oral cavity. Preferably, the material and size of the piezoelectric element are selected such that the energy generated is sufficient for the stated purposes.

[0211] The piezoelectric element is particularly well-suited for use as a bruxism sensor, as an energy source for operating electrical devices, and for the direct generation of biofeedback. The piezoelectric element thus integrates three functions previously unknown in this combination into a single component.

[0212] The piezoelectric element is preferably arranged on the device in such a way that it can optimally utilize the mandibular movement or the force generated by the mandibular movement. Piezoelectric elements can be, for example, certain crystals (piezocrystalline crystals) or piezoelectric ceramics, i.e., polycrystalline materials.

[0213] Preferably, the piezoelectric element is designed to generate acoustic, tactile, visual or electrical feedback when pressed by a movement of the lower jaw or by a force generated from the relative movement of the upper jaw and / or lower jaw.

[0214] The piezoelectric element can generate direct and indirect biofeedback. Direct biofeedback includes, for example, the ability of the piezoelectric element to produce a tone and / or vibration, depending on its design, which occurs, for instance, when a threshold is exceeded during activation. Further direct biofeedback can be generated when the piezoelectric element is positioned so that the generated current is conducted directly into the user's body and / or produces an electrical spark that is both visible and palpable. All of this provides feedback to the user, triggered by jaw movement. This has the advantage of eliminating the need for additional components for biofeedback, thus reducing manufacturing costs and potential for repairs, and improving wearing comfort.

[0215] Preferably, the piezoelectric element drives a vibration element and / or a buzzing device.

[0216] Unlike direct biofeedback, indirect biofeedback requires additional components such as a vibration element and / or a buzzing device. These components are connected to the piezoelectric element for power. They also only activate above a certain threshold, thus preventing false alarms. They offer the advantage that the biofeedback can be individually tailored to the user by adjusting the volume of the buzzing sound and / or vibration. Ideally, the vibration element and buzzing device are positioned or designed to minimize power consumption and ensure continuous functionality within the oral cavity.

[0217] Preferably, the piezoelectric element is configured to transmit electrical biofeedback to the user via a conductive surface of the device.

[0218] The piezoelectric element can provide direct biofeedback in the sense that, apart from a conductive surface connected to the current-generating piezoelectric element on one side and a body surface in the oral cavity on the other, no further components are required. The piezoelectric element can deliver a specific current and voltage to the user precisely at the moment or beginning of a bruxism event, and above a threshold determined by its size and design (and, if necessary, reduced by the resistance of the conductive surface). The current is chosen so that no medical damage occurs, but the user experiences sufficient disturbance during sleep to recognize the bruxism event, preferably without fully awakening. The device can also be used while awake to test for or protect against awake bruxism, in which case the biofeedback is perceived from a lower threshold.

[0219] Preferably, the device includes an energy storage device, preferably a battery.

[0220] The energy storage device enables the operation of additional electrical components and thus forms the basis for additional or improved functions of the device. The battery is preferably located in a position on the device that is not felt by the user – for example, within a support surface or the spacer, in order to reduce the risk of unwanted electric shocks through a non-conductive housing, or at least in a location that is not touched by the body.

[0221] The energy storage device can also support the piezoelectric element during the operation of the vibration element and / or the buzzing device. A conventional lithium or silver oxide battery, or a capacitor, can serve as the energy storage device. For example, button cells, such as the CR1216, which have a diameter of 12 mm and a thickness of 1.6 mm, can be used as the battery.

[0222] Preferably, the device comprises at least one, preferably several, and in particular all of the following units: a charging socket, for example for a USB connection, or a charging station; a microcontroller; a data storage device; a waterproof, non-conductive housing; a sensor that monitors force, muscle activity, vibration, and / or movement; and a feedback device for generating biofeedback, for example, a motor that generates vibration and noise. In the embodiment with additional electrical components or the housing, the function of the device is improved or extended: The charging socket or charging station allows the energy storage device to be charged inductively or via a cable connection. For example, charging via USB can be used, employing a waterproof connector conforming to the USB standard, e.g., Type B, Type C, Type Micro-B, etc.This improves usability and environmental friendliness, as the energy storage device does not need to be replaced.

[0223] In its simplest form, using circuit activation, a microcontroller is omitted to save space. The microcontroller can, for example, control the mechanical and electrical components, process their data, enable and monitor communication between them, provide a user interface, and ensure safety features (such as surge protection) against malfunctions, which may include self-diagnostics and an alarm system. Additionally, it can manage energy consumption to ensure efficient energy use (for example, reduced energy consumption outside of operating hours).

[0224] The most important function is the calculation of a bruxism event, for example, by means of short waiting times before feedback output, in order to avoid false alarms. Additionally, it can further reduce false alarms and / or enhance biofeedback, for example, by means of different, possibly progressively increasing, levels set by the user or medical professional based on threshold values ​​or threshold times.

[0225] Additionally, the microcontroller, by connecting to the piezoelectric element and / or sensor, can monitor the frequency, timing, intensity, or duration of bruxism, thus providing insights into the long-term development of the condition. Microcontrollers are already available in dimensions as small as 2 mm x 2 mm and at low cost. The data storage device allows for the storage of collected data (for example, the frequency of bruxism events, their duration, and the magnitude of the force exerted), thereby forming the basis for treatment based on objective and timely data collection. Data storage devices are also available, for example, as NAND flash memory chips in a size smaller than 2 x 2 mm and at low cost.

[0226] The waterproof, non-conductive housing protects the electrical components from corrosion and the user from damage, for example, from electric shocks or sharp edges. Preferably, the housing is round and without corners or edges, and is integrated into the device.

[0227] The sensor supplements the sensor function with the piezo element and / or the snap disc.

[0228] The feedback device can generate acoustic, visual, electrical, and / or tactile output. For example, it can include a loudspeaker for outputting voice messages and / or sounds. In a preferred embodiment, it consists of a motor that generates noise and vibrations at a volume that can be perceived by the user.

[0229] All electrical components are electrically interconnected, especially with the microcontroller, the energy storage device, and the piezo element.

[0230] Preferably, the device is wirelessly or via cable connection connected or connectable to a server and / or to an end device, for example a smartphone, in order to enable, for example by means of a software application, permanent data storage and monitoring of the user.

[0231] For the user, and potentially also for medical professionals, monitoring the course of bruxism is helpful. The first step involves an objective bruxism test, which, thanks to a connection to a smartphone, is no longer dependent on the user's sleep depth or pain sensitivity, nor on the diagnosis of pre-existing damage and pain. By connecting to a device such as a smartphone, smartwatch, tablet, and / or a server (possibly in the cloud), the collected data can be read and stored early on. This allows for additional measures such as muscle relaxation or medication, even in the case of more severe bruxism episodes—which, due to the nature of the condition, are not always recognized.Furthermore, data transmission allows for the measurement of short-term treatment success and long-term development based on objective data such as the frequency, duration, and severity of bruxism. Wireless communication can be implemented using methods such as Bluetooth, WLAN, Wi-Fi, NFC, Zigbee, cellular network, RFID, Low-Power Wide-Area Network (LPWAN), NB-IoT, LoRA, MIOTY, Sigfox protocol, LTE Category M1, Ingenu, and EnOcean protocol. A wired connection can be established, for example, via a USB-C charging port. Transmission can occur in real time, eliminating the need for data storage and potentially enabling external biofeedback, such as an LED on the charging station that lights up or flashes during a bruxism event, or a comparable function on a smartphone that activates light or sound.Alternatively, data transfer can occur at longer intervals (for example, once a day, or via a cable connection when plugged into the device or during charging), which reduces power consumption for data transmission. A software application can simplify operation and, for example, graphically display the collected data. The software application can also be used to configure data transfer schedules and other control settings.

[0232] Preferably, the device or charging station has an LED, the LED flashing when the device is on the charging station and being charged, and continuously lit when the energy storage is charged, and also providing external visual biofeedback via a light signal in the event of a bruxism event.

[0233] The LED can be mounted on the device or, preferably, on the charging station. For example, the LED can flash to indicate the charging process after the device is placed on the inductive charger. A continuously illuminated LED allows the user to see that the device is charged and ready for use. This reduces the risk of the power running out during use, preventing the components that require a power supply from functioning. Additionally, this design offers an alternative and / or complement to luminescence, as it reminds the user to use the device at night. Furthermore, the LED on the charging station can illuminate or flash in real time during a bruxism event, because the bruxism event is transmitted to the charging station as the end device. Alternatively, the same function can be implemented directly on the device.

[0234] Preferably, at least one support element and / or the spacer are formed or connected to each other by a hinge or a joint, in particular a ball joint or single-axis joint, wherein the upper and / or lower support element is connected to the spacer formed as a joint, in particular by a connection that is or can be made under force or heating.

[0235] A hinge or joint, such as a ball joint or a single-axis joint, allows the device to adapt more readily to the individual anatomy of the user, as, for example, the upper contact surface can adjust to the angle and / or relative movement of the palate. This increases wearing comfort. Additionally, a hinge or joint can act as a spring, absorbing some of the force generated by the movement of the lower jaw (and releasing it again when returning to the starting position), thus further enhancing wearing comfort. The hinge or joint can be integrated into the spacer or a support element, or it can be a separate component.A ball joint combined with a biofeedback device - such as a snap disc or a piezo element - can lead to a controllable movement path with high trigger reliability and reduce the risk of material fatigue fractures.

[0236] The connection between the spacer and the support element can be designed as a snap-fit ​​connection, bayonet fitting, clamping connection, positive-locking guide with stop, thermoplastically deformable connection, elastic membrane, connection secured by force or heat, or a combination thereof. Connections secured by force or heat simplify production and allow for quick replacement of the spacer – both by skilled personnel and by the user. In the event of a defect, the entire device does not need to be remanufactured. It also allows for adjustments to compensate for inaccuracies in fit during test fitting. Furthermore, the hinge-based connection in the above-mentioned embodiments allows for precise alignment and contributes to the modularity, ease of maintenance, and, if necessary, simplified cleaning of the device.

[0237] Preferably, a support element has one or more fastening elements to attach the device to one or more teeth of the lower jaw and / or upper jaw and / or in the oral cavity, and / or which is / are designed for temporary or permanent attachment to one or more dental appliances, in particular braces or dental splints, placed in the oral cavity.

[0238] Additional fastening elements ensure that the device maintains its intended position in the oral cavity during use. These fastening elements can be attached directly to the body or via dental appliances (such as splints, braces, retainers, bridges, crowns, partial and complete dentures, implants, onlays, veneers, expanders, aligners, brackets, activators, and expansion plates) that are themselves attached to the body. The most advantageous fastening method depends on the user—for example, if braces are already present, attachment to them is beneficial. When attaching to the body, in addition to the previously mentioned requirements, such as tongue restraint, attachment can be made to or behind the teeth or within the oral cavity.For this to work, the device must have the appropriate shape, for example following the floor of the mouth or the palate, narrowing towards the mouth and thus providing a natural point of support, and / or encompassing the teeth laterally.

[0239] Attachment elements can also be defined solely or additionally by the shape of their surface, which may be textured or feature bumps or suction cups. When attaching them to the teeth, care must be taken to avoid causing misalignment or any other damage to the teeth. For example, in the case of retromolar attachments, the attachment can be made on the gum line. On the teeth themselves, this can be achieved through a specific shape that utilizes one or more interdental spaces or the shape of the entire tooth. This can be accomplished, for example, using an attachment made of a material that does not damage the enamel, or via a wire or casting mold. The attachment can also be individually adjusted by the user or a medical professional.

[0240] Wire fixation can be applied in various ways: on the inside of the teeth, on the outside of the teeth, in the interdental spaces, over the teeth, or as a combination of two or more of these methods. The wire can be attached to both the upper and lower jaw. It is important to ensure that the spacer is sufficiently high and / or that the wire is positioned so that it does not come into contact with the chewing surfaces and / or teeth during a bruxism event, or at least does not cause damage.

[0241] Preferably, the fastening element is designed in the form of a labial arch and / or lingual arch, wherein the fastening element comprises a wire and / or an elastic for temporary or permanent attachment, wherein the wire and / or elastic is preferably individually adapted to the shape of the tooth or dentition, and / or wherein the fastening element comprises a retention device placed in the interdental spaces and / or a wire and / or elastic attached to the sides of the teeth and / or a retention device attached at the transition of the occlusal surfaces between two teeth.

[0242] The attachment can be designed in different ways: In the form of a labial or lingual archwire, the wires can be perfectly adapted to the shape of the teeth by a dental professional. Alternatively, the wire, in the form of a loose loop, encircles the row of teeth and / or the underlying gum tissue, providing support while still allowing for some movement of the appliance. This has the advantage that no, or at least less complex, adjustments by a dental professional are necessary, and the appliance still remains in the intended position.

[0243] In its labial arch configuration, one possible design allows the wire to be anchored to the device only once, thus enabling its use despite varying overall dentition lengths. Attaching the wire on two sides carries the risk of it being too long and protruding from the mouth, or too short and unable to provide adequate support. While most dental applications, such as splints, require a perfect fit on inflexible teeth and therefore precise adaptation to the individual tooth shape, the device according to the invention, when positioned on more flexible soft tissues, only needs to be placed within a few millimeters in the mouth. This means the primary function of the attachment element is to prevent the device from falling out or being unconsciously removed from the mouth. In fact, the wearing comfort of the device according to the invention increases with minimal movement within the oral cavity.

[0244] As a retention device placed in the interdental spaces, it can be designed, for example, as a conical shape (such as a wedge) or as a cylinder with a conical tip (comparable to an interdental brush without a handle and bristles) or as expandable stents or as barbs, all of which have in common that they can be removed after use.

[0245] As a retaining device at the transition of the occlusal surfaces between two teeth, using only transitions that include a depression, the fastening element can be designed, for example, as a wire or elastic rubber bands, as long as the wire and generally the connecting piece are kept thin enough so that the wire and the occlusal surface on the other jaw do not touch or do not touch significantly.

[0246] All these fasteners offer a secure fastening option that makes accidental slippage or removal of the device very difficult.

[0247] Preferably, at least one of the support elements consists partly of a flexible material, for example a silicone cushion, or at least one of the support elements is partly covered with a flexible material, for example silicone, or at least partially enclosed by an elastically deformable shell, for example made of silicone, wherein the shell is preferably attached over the support element in a form-fitting and / or force-fit manner.

[0248] Wearing comfort is one of the key criteria for the long-term use of the appliance. The more rigid the material, the less adaptable the appliance is to the individual anatomy in the mouth. Soft material on at least one support element, as well as a rounded shape, reduces the risk of injury and increases wearing comfort. The flexible material can consist of, for example, silicone, thermoplastic elastomers, KeySplint Soft, or polyurethane (PU). During the design process, care must be taken to ensure that the flexible material does not impair the spacer function and does not create excessive play, which in turn leads to a wider open bite position and thus reduced wearing comfort.

[0249] Preferably, the parts of the device that come into contact with the body, especially the soft tissues, and are particularly exposed to the biting force generated by the movement of the lower jaw, are formed from or coated with a compliant material.

[0250] Preferably, an attachable and / or removable adjustment device is provided, preferably on the upper or lower support element or the spacer, to individually adapt the outer shape of the device to the user's oral cavity, preferably the size of the device, or to increase or decrease wearing comfort to generate biofeedback, for example by the surface shape of the adjustment device in the form of a cylinder, a flattened sphere, a hemisphere, a spindle or a cone.

[0251] The adjustment device allows for modification of the device's shape, and there are various reasons for such an adjustment: The device may not fit the user optimally in its standard sizes, for example, if the user has a tongue that is too narrow compared to the standard design. In this case, attaching an adjustment device to the spacer towards the tongue can be useful to reduce the gap and improve the fit. If, for example, the height is insufficient for maintaining the necessary distance, an adjustment device can be attached to one of the support elements to increase the device's height. These adjustment devices can be standardized mass-produced items or individually manufactured or adapted by the user or medical professionals.

[0252] A second reason for using adjustment devices can be to improve wearing comfort. If the device causes pressure points in one area, an adjustment device can be attached at that or another location. This can be achieved, for example, by using a softer shape or by relieving the pressure point from the force generated by jaw movement. Conversely, at least one adjustment device can be used to generate biofeedback, for example, by providing mechanical biofeedback at the upper, lower, or middle support element. This biofeedback can be amplified or diminished by using different sizes, shapes, or materials for the adjustment device, allowing for adjustments to the user's current goals (e.g., depending on the severity of their bruxism) during each period of use.In many patients, the sensation of jaw position is initially so weak or bruxism so pronounced that a smooth surface of the device is sufficient for biofeedback, and interchangeable adjustment mechanisms only become useful over time to maintain the biofeedback. In any case, skin injuries to the soft tissues or abrasiveness that could lead to skin damage over time must be avoided.

[0253] The removable design allows the user to identify the optimal fit, for example, during a fitting. Various material types, ranging in firmness from very soft to very hard, facilitate this process. An adjustment mechanism can also be a wide elastic band attached to two opposing parts of the device to narrow the tongue rest. Based on the individual measurements obtained, it is then possible to create a custom-made device that requires no further adjustments. The removable design also allows for the addition and removal of certain functions—for example, biofeedback via a snap disc, piezoelectric element, or mechanical biofeedback, or electrical devices—when the user's focus is on maximum comfort and, if necessary, undisturbed sleep (for example, before an important appointment).The fitting device can be attached in a through-hole or without a through-hole or without a pre-existing mounting (for example, by means of a clamp). The specific embodiments of the fitting device are limited only by the shape and size of the oral cavity and the device itself. Preferably, the support elements and / or the fitting devices are designed to be movable.

[0254] A flexible design increases wearing comfort, as the device can adapt better to individual anatomy and can also create a certain spring effect. This flexibility can be achieved through various designs, from hinges and ball joints to wall thicknesses and shapes, as well as different fastening methods.

[0255] Preferably, the support elements and / or the adjustment devices are formed or connected to each other by a hinge or a ball joint.

[0256] A movable design using hinges and ball joints increases wearing comfort, as the device can adapt better to the individual anatomy and, in the case of hinges, also creates a greater spring effect.

[0257] Preferably, the adjustment device is adjustable in length and / or position.

[0258] The adjustability further increases the adaptability to individual anatomy and thus the wearing comfort.

[0259] Preferably, the adjustment device comprises a functional part and one or more connecting parts, wherein the connecting part is designed to connect the adjustment device to the upper and / or lower support element and / or spacer.

[0260] The connecting part securely attaches the adjustment device to the device, which may have a receiving device compatible with the connecting part. Without the connecting part, the secure attachment of the adjustment device to the device would be significantly less secure. The connecting part can be configured, for example, with at least one plug connection, screw connection, bayonet coupling, clamp connection, or other type of connection. Permanent connections, such as those made with adhesives, are also possible. The functional part can perform one or more functions, such as increasing wearing comfort, enlarging the device, or generating or reducing biofeedback. Preferably, the connecting part(s) have a threaded nut.

[0261] A threaded nut has the advantage of providing a very secure connection that won't loosen accidentally and can be retightened if necessary. Preferably, the threaded nut is designed to be as unobtrusive as possible for the user. This is achieved in particular by positioning the threaded nut in a location that doesn't touch the user's body and / or by using a flat threaded nut, possibly with a blind nut featuring a rounded end from which the screw does not protrude.

[0262] Preferably, the functional part has an upper part and a lower part, the lower part being optionally provided with a thread.

[0263] Separating the upper and lower parts improves manufacturing, handling and functionality, especially the precise fit, as the lower part is standardized and optimized for connection with a threaded nut.

[0264] Preferably, the upper part has a cylindrical shape, a flattened spherical shape, a hemispherical shape, a spindle shape or a conical shape.

[0265] The various shapes and sizes mentioned in this claim are designed to generate the optimal level of biofeedback – they are noticeable to the user during jaw movement and can thus trigger a change, but without causing sores or irritation after wearing. Not only the shape, but also the size of each design is essential.

[0266] Preferably, the shape of the upper part is designed to increase or reduce wearing comfort, wherein the shape of the upper part to increase wearing comfort has in particular a larger contact area with the oral cavity, especially the palate, and to reduce wearing comfort in the form of biofeedback has in particular a tapered or pointed shape with a small base area.

[0267] Generally, small or narrow structures in the oral cavity feel sharp to the user and are therefore painful with sufficient mandibular movement, regardless of their exact shape. Thus, small structures are better suited for biofeedback than large ones. With larger structures, the shape is crucial; a wide, flat shape generally increases wearing comfort, whereas a narrow, flat shape generally decreases it. Given the size of the oral cavity, it's worth noting that a small structure is up to 1 or 2 millimeters in size, while a large structure starts at just a few millimeters. The placement also plays a role: teeth are the least sensitive. The tongue is not very sensitive. The palate is also not very sensitive, but due to its lack of mobility / movement, it is somewhat more sensitive than the tongue, and the floor of the mouth is the most sensitive.Here too, the design of the upper parts is limited only by the size of the oral cavity and the device. Different upper parts allow the user to individually adapt to their needs, which may change over time.

[0268] Preferably, the material of at least one part of the device, preferably the entire device together with all other parts described in this disclosure, such as sets and their connecting means and / or adjustment devices, is biocompatible.

[0269] Since the device is worn in the oral cavity, a crucial criterion is that the material used does not cause any harm to the user. Accordingly, the material must be biocompatible with the user's body and must not cause any damage and / or unwanted reactions. Preferably, all parts are biocompatible, although, depending on the embodiment, areas without skin contact or materials or parts in waterproof housings that are separate from the body may have lower requirements.

[0270] Preferably, the device material comprises PA2200 (polyamide), acrylate, PETG (polyethylene terephthalate glycol), PMMA (polymethyl methacrylate), PVC (polyvinyl chloride), PET (polyethylene terephthalate), PP (polypropylene), PEEK (polyetheretherketone), PEI (polyetherimide), silicone, stainless steel, titanium, cobalt-chromium alloys, tantalum, thermoplastic, photopolymer resin, in particular KeySplint Soft, and / or zirconium, wherein the material of at least part of the device, preferably the entire device, is biocompatible.

[0271] The materials used should be biocompatible and corrosion-resistant. It is advantageous if they are already used in medical technology, and preferably in dentistry. At least one material should have a soft surface texture, and at least one material should ensure proper spacing, for example, through its inherent material properties and / or the design (e.g., wall thickness). These properties ensure a high level of comfort and a long service life, and prevent material-related injuries to the user.

[0272] Biocompatible, as defined in this disclosure, means that the material or product used does not cause harmful biological reactions in the human body under foreseeable use. The assessment is carried out in accordance with DIN EN ISO 10993 and takes into account, in particular, cytotoxicity, sensitization, and irritation.

[0273] The device can, for example, be additionally provided with antimicrobial additives to reduce the formation of germs on the surface.

[0274] Preferably, at least part of the device and / or the adjustment device is manufactured using 3D printing, deep drawing, coating, milling, grinding, polishing and other manufacturing processes suitable for individualization.

[0275] Adapting the device to the individual anatomy sometimes makes its use possible in the first place, increases wearing comfort and contributes to improved fixation at the intended attachment point.

[0276] Preferably, at least part of the device is designed to harden under the influence of visible light, radiation, after heating or in another way in order to assume a permanent shape and / or wherein the device comprises thermoplastics, photopolymer resin, a two-component paste or a combination thereof.

[0277] These manufacturing processes are more environmentally friendly than milling or coating, as they produce fewer pollutants and less waste. Manufacturing processes that can be used by both medical professionals and the user are preferred. If the user performs the customization themselves, manufacturing costs are reduced and the device can be used more quickly. Particularly with light- or radiation-cured materials, the finest details and intricate structures can be realized, which in turn increases wearing comfort. It is expressly clarified that the permanent shape cured by the influence of visible light, radiation, heating, or by other means is retained until reheating or re-irradiation (possibly with light), whereby reheating or re-irradiation (possibly with light) may allow for a further change in shape.

[0278] Preferably, based on a 3D scan and / or an impression and / or a stress test of the floor of the mouth by the user himself and / or medical professionals, an individual adaptation of the device to the user's oral cavity can be made and / or the variant with the most suitable properties can be selected from existing size variants, wherein at least a part of the device and / or the adaptation device is manufactured by means of 3D printing, deep drawing, coating, milling, grinding, polishing or other manufacturing processes suitable for individualization.

[0279] An additional stress test of the floor of the mouth can be performed to determine the underlying bone structure and elasticity of the floor of the mouth, thus enabling the correct height of the spacer to be determined (for example, using an indentation test, compression test, or demonstration models of the device at different heights). A 3D scan or a physical impression (for example, an alginate impression of the oral cavity, which is then cast with super-hard plaster) allows for a precise representation of the oral cavity, so that optimal fit and therefore wearing comfort can be achieved during the subsequent customization of the device (which may simply consist of selecting from different size variants).

[0280] The “most suitable features” in the sense of this claim refer to the geometric characteristics of the device, which are selected or adapted based on the individual anatomical conditions of the user in order to ensure an optimal fit, function and wearing comfort.

[0281] These properties of the device relate in particular to: the height of the device, especially of the spacer, the support elements and / or spacer washers, the width of the device, especially in the area of ​​the tooth arc,

[0282] • the length of the device, both in the area of ​​the upper and the lower support element.

[0283] • The shape of the device, especially in the area of ​​the tongue and palate

[0284] The selection or adjustment of these properties is based on the user's individual anatomical characteristics, in particular:

[0285] • the palatal height in the area of ​​the upper support element,

[0286] • the tooth shape,

[0287] • the position of the teeth,

[0288] • the width of the dental arch,

[0289] • the length of the dental arch,

[0290] • the length and size of the tongue,

[0291] • the shape of the palate.

[0292] Preferably, the device comprises thermoplastics or a two-component paste.

[0293] Thermoplastics can be deformed at high temperatures and fixed in a new shape upon cooling. They can be reheated and reshaped multiple times, facilitating customization and personalization for the user. They are available in various degrees of hardness and are cost-effective.

[0294] Two-component systems (such as epoxy or polyurethane pastes) can achieve customized mechanical and chemical properties by mixing different components. These pastes offer strong adhesion to a wide variety of substrates and are often resistant to cleaning chemicals and moisture. They are also available with varying working times. After curing, they offer high strength and stability. In summary, these materials are very well suited for customizing devices or parts thereof.

[0295] Preferably, a, preferably upper, part of the upper support element and / or a part of the lower support element and / or a part of the middle support element comprises thermoplastic material that has a deformation temperature above the body temperature but below the boiling point of water, preferably in the temperature range of 50-100 degrees Celsius.

[0296] Within this temperature range, the material is adaptable in hot or boiling water, while simultaneously retaining its stable shape on or inside the body. This allows the user to easily adjust the body-contacting support elements to their individual needs.

[0297] Preferably, the parts are made of thermoplastic material and designed to be plugged in.

[0298] The snap-on design allows the thermoplastic parts to be securely and precisely attached to the intended position. Preferably, a fastener is used that is not thermoplastically deformable, but rather optimized for attachment to the device.

[0299] In another aspect, a set is proposed comprising a device according to the invention and one or more dental appliances, for example braces and / or dental splints; and one or more connecting means for connecting the device and the dental appliances.

[0300] This set allows you to achieve several desired changes simultaneously, such as preventing snoring and correcting misaligned teeth at the same time. Furthermore, attaching the device to a dental appliance ensures that it remains securely in place. The connecting elements are preferably tailored to the specific appliance and are made of materials such as metal or plastic.

[0301] A connecting element can, for example, comprise a hook, pin, wire, or band. The connecting element can be permanently attached to the device and the dental application. Preferably, it can be opened and closed by means of a locking mechanism. Depending on the design, the dental appliance, such as the splint, can either be an integral part of the device according to the invention, or the device according to the invention can be attached to an existing splint from another manufacturer. Preferably, a design is used in which no small parts can be swallowed and yet separation is possible, i.e., a permanent connection on one side.

[0302] Preferably, the set includes an intermediate piece, wherein, in the assembled state, the intermediate piece is provided between the dental splint and / or brace and / or other dental appliances and the device.

[0303] The connecting piece is made of a material that is not deformable at body temperature and connects the dental appliance to the device in the intended position. It can be either attachable or removable, and can be designed as a permanent connection on one or both sides. The permanent connection on one side can be made with the connecting piece, the dental appliance, or the device.

[0304] The intermediate piece can also be made of thermoplastic material or designed to accommodate adjustment devices, allowing the shape to be adapted to optimize spacing and wearing comfort. The use of an intermediate piece offers the advantage of quick and easy attachment and removal.

[0305] Preferably, the connecting means has an annular locking mechanism, wherein the locking mechanism in the assembled state is guided through a through hole in the dental splint and / or brace and / or other dental appliances to lock the dental splint and / or brace and / or other dental appliances to the device.

[0306] The option of securing the appliance using one or more small through-holes in the dental device offers the advantage that, with a locking mechanism, removal of the appliance becomes significantly more difficult, while still allowing for slight movements. This increases comfort during jaw movement. This type of fastening is secure for users and therefore particularly suitable for those with restless sleep who tend to unconsciously remove the appliance while half asleep. Possible locking mechanisms include snap closures, push-button closures, magnetic closures, or twist locks. With multiple through-holes, the user can choose the most suitable one.

[0307] Preferably, the material of at least part of the device, preferably of the entire device, is luminescent.

[0308] Especially in patients with mild bruxism or during periods of mild bruxism, the use of the device or a mouthguard is often forgotten. Accordingly, the device according to the invention, or at least a part of the device, is designed with a luminescent material or a luminescent outer coating, so that the user—if the device is kept in the bedroom and used during sleep bruxism—is reminded of its use by the luminescence as they fall asleep. The luminescence is designed so that the patient's face does not glow from the outside (for example, on the back of the throat and through the use of a material that is not too bright). This luminescence also has the advantage that the device can be found (more quickly) if it is accidentally removed from the mouth at night.

[0309] In another aspect, a method for manufacturing a device for the treatment and / or prevention and / or testing of bruxism and / or craniomandibular dysfunction (CMD) is proposed, comprising the following steps:

[0310] Obtaining and / or creating a digital or physical model of the user's oral cavity, in particular including the palate and teeth (for example, by means of an alginate impression of the dentition, which is then cast with super-hard plaster); and

[0311] Using the digital or physical model of the user's oral cavity to create the device according to the invention, preferably by means of a computer system and optionally with the support of an AI-assisted (artificial intelligence) analysis for (semi-)automatic evaluation, in order to propose or determine an anatomically and functionally optimized configuration of the device, wherein the use comprises: o virtual shaping of an upper support element, the outer surface of which is designed to correspond to at least a part of the palate, o virtual shaping of the lower support element, wherein the lower support element has an outer surface that is shaped to correspond to at least a part of the mandible, o preferably further virtual shaping of the lower and optionallyThe device comprises: the middle support element and the tongue rest, wherein these parts have an outer surface shaped to correspond to at least part of the tongue; selection of the correct height and width of the preferably digital, prefabricated parts of the device, in particular the spacer; virtual positioning of the spacer in relation to the oral cavity and the support elements, such that a cavity is formed which is shaped to ensure the distance between the occlusal surfaces; virtual positioning of the attachment element(s) in the oral cavity; and preferably virtual positioning of the biofeedback device.

[0312] The described method enables medical professionals to create a precisely fitting, individually adapted device, with a focus on determining the optimal height of the spacer. This is preferably done using a model with a slightly open mandible, so that the occlusal surfaces do not touch. This can also be achieved using semi-automatic or automatic methods, optionally with the support of artificial intelligence and requiring only approval from the medical professional. In this context, the term "corresponds" to the tongue preferably refers to a fit that is smaller in dimensions than the tongue, so that pressure is exerted on the tongue, thereby holding the device and tongue in place.

[0313] Further advantages and features are described below with reference to the attached figures. These show:

[0314] Figs. 1a to 1f show a device according to a first embodiment;

[0315] Figs. 2a and 2b show a device according to a second embodiment;

[0316] Figs. 3a and 3b show a device according to a third embodiment;

[0317] Fig. 4 shows a device according to a fourth embodiment;

[0318] Fig. 5 shows a device according to a fifth embodiment;

[0319] Figs. 6a to 6c show a device according to a sixth embodiment;

[0320] Figs. 7a to 7c show a device according to a seventh embodiment;

[0321] Figs. 8a to 8d show a device according to an eighth embodiment;

[0322] Figs. 9a to 9d show a device according to a ninth embodiment;

[0323] Figs. 10a to 10c show a device according to a tenth embodiment;

[0324] Figs. 11a to 11c show a device according to an eleventh embodiment;

[0325] Figs. 12a to 12c show a device according to a twelfth embodiment;

[0326] Figs. 13a to 13c show a device according to a thirteenth embodiment;

[0327] Figs. 14a to 14c show a set according to a fourteenth embodiment;

[0328] Figs. 15a and 15b show a set according to a fifteenth embodiment;

[0329] Figs. 16a and 16b show a set according to a sixteenth embodiment;

[0330] Figs. 17a to 17d show a set according to a seventeenth embodiment; Figs. 18a to 18c show a set according to an eighteenth embodiment;

[0331] Figs. 19a to 19c show an adjustment device;

[0332] Figs. 20a to 20c show a variant of the adjustment device;

[0333] Figs. 21a and 21b show another variant of the adjustment device;

[0334] Figs. 22a and 22b show another variant of the adjustment device;

[0335] Figs. 23a and 23b show another variant of the adjustment device;

[0336] Figs. 24a and 24b show another variant of the adjustment device;

[0337] Figs. 25a and 25b show another variant of the adjustment device;

[0338] Figs. 26a and 26b show another variant of the adjustment device;

[0339] Figs. 27a and 27b show another variant of the adjustment device;

[0340] Figs. 28a and 28b show another variant of the adjustment device;

[0341] Figs. 29a to 29e show another variant of the adjustment device;

[0342] Figs. 30a, 30b, 31a, 31b, 32a, 32b, 33a and 33b show further variants of the adjustment device;

[0343] Figs. 34a to 34e show another variant of the adjustment device;

[0344] Figs. 35a to 35e show another variant of the adjustment device;

[0345] Figs. 36a to 36c show a device according to a nineteenth embodiment with the attachment of a further variant of the adaptation device;

[0346] Figs. 37a to 37c show a device according to a twentieth embodiment with the attachment of a further variant of the adaptation device;

[0347] Figs. 38a to 38c show a device according to a twenty-first embodiment with the attachment of a further variant of the adaptation device; Figs. 39a to 39c show a device according to a twenty-second embodiment with the attachment of a further variant of the adaptation device;

[0348] Figs. 40a to 40c show a device according to a twenty-third embodiment with the attachment of a further variant of the adaptation device;

[0349] Figs. 41a to 41c show a device according to a twenty-fourth embodiment with the attachment of a further variant of the adaptation device;

[0350] Figs. 42a and 42b show a device according to a twenty-fifth embodiment with the attachment of a further variant of the adaptation device;

[0351] Figs. 43a to 43e show a device according to a twenty-sixth embodiment with an attachment of a variant of a snap disc;

[0352] Figs. 44a to 44c show a device according to a twenty-seventh embodiment with the attachment of a further variant of a snap disc;

[0353] Figs. 45a to 45e show a device according to a twenty-eighth embodiment with the attachment of a further variant of a snap disc;

[0354] Figs. 46a to 46f show a device according to a twenty-ninth embodiment with the attachment of a further variant of a snap disc;

[0355] Figs. 47a to 47c show a device according to a thirtieth embodiment with the attachment of a further variant of a snap disc;

[0356] Figs. 48a to 48c show a device according to a thirty-first embodiment with the attachment of a further variant of a snap disc; Figs. 49a to 49c show a device according to a thirty-second embodiment with the attachment of a further variant of a snap disc;

[0357] Figs. 50a to 50c show a device according to a thirty-third embodiment with the attachment of a further variant of a snap disc;

[0358] Fig. 51 shows the physical principle for the functioning of a snap disc;

[0359] Figs. 52a and 52b show a device according to a thirty-fourth embodiment with an attachment of a variant of a piezoelectric device;

[0360] Figs. 53a and 53b show the physical principle of a piezoelectric device;

[0361] Figs. 54a to 54d show a device according to a thirty-fifth embodiment with a battery-operated biofeedback mechanism;

[0362] Figs. 55a to 55f show a device according to a thirty-sixth embodiment with a single-axis joint;

[0363] Figs. 56a to 56f show a device according to a thirty-seventh embodiment with a ball joint;

[0364] Figs. 57a to 57f show a device according to a thirty-eighth embodiment with spacers;

[0365] Figs. 58a and 58b show a first embodiment for an upper support element;

[0366] Figs. 59a and 59b show a second embodiment for an upper support element;

[0367] Figures 60a to 60c show a third embodiment for an upper support element in conjunction with a uniaxial joint; Figures 1a to 1f show a first embodiment of the device 100 from the front view, side view, and top view. Figures 1a to 1c show the device 100 in the unsupported state, and Figures 1d to 1f show the device 100 in the supported state.

[0368] The device 100 comprises an upper support element 102 for receiving the upper jaw 110 and a lower support element 104 for receiving the lower jaw 112. Three spacers 106 are provided between the upper support element 102 and the lower support element 104. Upper and lower support means, in particular, that the support is directed upwards, i.e., towards the palate, and downwards, i.e., towards the floor of the mouth, respectively. The upper and lower support directions are preferably almost perpendicular to each other to achieve a more stable position.

[0369] One end of the spacers 106 is connected to the upper support element 102, and another end of the spacers 106 is connected to the lower support element 104. The spacers 106 are designed to prevent contact forces on the occlusal surfaces of the teeth or at least to reduce them so significantly that no damage occurs. For the purposes of this disclosure, a substantial reduction in contact forces on the upper and / or lower occlusal surfaces means a reduction of at least 50%, preferably 75%, and more preferably 100% of the contact force. This reduction can be achieved by decreasing the number of bruxism events, the duration of bruxism events, the contact force during a single bruxism event itself, or a combination of these factors.

[0370] In the first embodiment, this is achieved by arranging the spacers 106 in the middle and on both sides of the support elements 102 and 104, with the spacers 106 being substantially perpendicular to both the upper support element 102 and the lower support element 104. This allows the left and right sides of the support elements 102 and 104 to be oriented symmetrically with respect to the spacers 106.

[0371] A contact force on the occlusal surfaces is a force that arises when the upper and lower teeth exert force on each other, possibly separated by a material. In other words, the spacer 106 is designed to prevent contact between the upper and lower teeth or at least to allow it only to such an extent that no damage occurs. In this embodiment, the upper support element 102 is designed for placement in the upper oral vestibule and the lower support element 104 for placement in the lower oral vestibule.

[0372] One possible location for attaching the device 100 is, for example, outside the dental arch, vertically between the teeth and the inner cheeks, and horizontally on the gums. This means that, according to the first embodiment, the device is intended for attachment in the oral vestibule (vestibulum oris).

[0373] As can be seen in Figs. 1b and 1e, the device 100 has a wedge-shaped form when viewed from the side, with the short edge pointing towards the pharynx and the long edge towards the mouth. Such a shape corresponds to the oral structure, so that at the point of application (when worn in the mouth) the upper and lower teeth are separated from each other to prevent or at least reduce contact.

[0374] The spacer 106 can have a height of 1–8 cm, preferably 2.5–5 cm when placed in the oral cavity. The oral cavity (cavum oris) is the space bounded anteriorly by the lips, superiorly by the hard and soft palate, which separates it from the nasal cavity, laterally by the cheeks, and inferiorly by the floor of the mouth. The further the spacer is placed from the temporomandibular joint, the larger it must be to function properly, taking into account its positioning on or against the support elements and their height. It is further preferred that the height of the spacer and / or the device be adjustable to individual needs.

[0375] To keep a substantial part of the oral cavity clear, the device has a size of 500 to 40,000 mm. 3 on, preferably 1,000 to 15,000 mm 3 and preferably 2,000 to 9,000 mm 3Due to the large contact areas between the oral mucosa and the device 100, the force exerted by the relative movement of the upper and lower jaw can be reduced overall. This reduces potential inflammation and protects the oral mucosa.

[0376] Figures 2a and 2b show a device 200 according to the second embodiment in side and top view. The device 200 according to the second embodiment differs from the device of the first embodiment in that the upper support element 202, the lower support element 204 and the spacer 206 are formed in one piece.

[0377] At the point of attachment, the upper and lower surfaces 202 and 204 of the spacer 206 can be considered the upper and lower support elements. The device 200 can consist of two (left and right) such one-piece structures, each of which can be placed, for example, next to the last or penultimate molar. By placing it close to the temporomandibular joint, the device can be made smaller, thus saving on manufacturing costs.

[0378] Furthermore, an arch 214 can be provided to connect the one-piece structures. When worn in the mouth, the device 200 can be positioned vertically between the upper jaw 210 and lower jaw 212, and alongside the outer surfaces of the last or penultimate molars. Due to the height of the spacer, the upper and lower teeth are separated from each other to prevent contact or to allow only slight contact without causing damage.

[0379] The spacer 206 can have a height of 0.5–3 cm, preferably 1–2 cm. It is further preferred (also in all other embodiments) that the height of the spacer and / or the device as described in Fig. 1 is adapted to individual needs.

[0380] Figures 3a and 3b show a device 300 according to the third embodiment in a front view and a top view. As in the second embodiment, the upper support element 302, the lower support element 304, and the spacer 306 are also formed in one piece. At the mounting location, the upper and lower surfaces 302 and 304 of the spacer 306 can also be considered the upper and lower support elements.

[0381] Device 300 differs from device 200 in that the spacer 314, which connects the one-piece structures, sits against or rests against the upper jaw 310 when worn at the posterior part of the mouth. Accordingly, the left and right one-piece structures are not located next to the outer surfaces of the second or third molars, but rather in the retromolar space (the area behind the last teeth). This design allows device 300 to be easily attached to a suitable location in the oral cavity and ensures a distance between the occlusal surfaces of all teeth. Devices 100, 200, and 300, unlike the other embodiments shown in the figures, do not have a tongue rest.

[0382] Fig. 4 shows a device 400 according to a fourth embodiment, which is again formed in one piece. The device 400 is located between the upper jaw 410 and the lower jaw 412. At the point of attachment, the upper jaw 410 rests on the upper support element 402, and the lower support element 404 rests on the tongue 414. A retaining device 410 behind the last molar also supports the positioning vertically.

[0383] Unlike the first and second embodiments, the device 400 is designed to be placed within the dental arch (cavum oris proprium). This means that the device 400 is enclosed by the dental arches. This preferred placement prevents continuous irritation of the gums and increases wearing comfort.

[0384] Fig. 5 shows a device 500 according to a fifth embodiment. The device 500 is located vertically between the upper jaw 510 and the lower jaw 512. At the point of attachment, the upper jaw 510 rests on the upper support element 502, and the lower jaw 512 rests on the lower support element 504. As in the fourth embodiment, the device 500 is designed to be placed within the dental arch (cavum oris proprium). This means that the device 500 is enclosed by the dental arches. Such a placement prevents continuous irritation of the gums and increases wearing comfort.

[0385] To accommodate the tongue 514, the device 500 has a cavity (recess). In this embodiment, the tongue holds the device and the device holds the tongue (tongue support). In this context, tongue support can therefore mean that the tongue is held in position and does not fall back, thus preventing snoring or obstructive sleep apnea, and / or that the device 500 is held in place by being attached to the tongue. The tongue support is not limited to this embodiment. The tongue support is thus formed by all elements that come into contact with the tongue when in the user's oral cavity. The same applies analogously to all other embodiments, without this being explicitly repeated.

[0386] Specifically, in this embodiment, the tongue holder is formed by the two spacers 506, the upper support element 502, and the lower support element 504. In other embodiments, this may differ, and, for example, a middle support element may also be part of the tongue holder.

[0387] The two spacers 506 are attached to both sides of the device 500 so that the tongue 514 is obstructed as little as possible. The height of the spacer 506 is set such that contact between the occlusal surfaces 508 of the teeth is prevented or significantly reduced.

[0388] It is preferred to adapt the height of the spacer and / or the device to individual needs. In this embodiment, the lower support element 504 is provided under the tongue on the floor of the mouth 512, which prevents the device 500 from slipping.

[0389] Figs. 6a to 6c show a device 600 according to a sixth embodiment.

[0390] The device 600 is also designed for placement within the dental arches. The upper support element 602 of the device 600 has an arc to adapt to the shape of the palate. The lower support element 604 of the device 600 is designed to be placed not on the tongue, but between the tongue and teeth. In this embodiment, it is positioned on the inner surface of the lower teeth (and in further embodiments, on the inner surfaces of the upper teeth) by a retaining device 608, thereby securing the device 600 to the teeth or at least stabilizing its position. This embodiment also features a tongue support due to its shape. Preferably, the retaining device 608 is made of metal wires, e.g., stainless steel, which ensures strong fixation and durability.In this embodiment, the retaining device 608 extends across the inner surface of the lower dental arch to the last teeth (for example, the second or third molars). The wire can be attached to one or two legs on the respective side of the last tooth.

[0391] Viewed from the side, the device 600 has the shape of an open ring (Fig. 6c), with the upper part of the open ring forming the upper support element 602. The legs extend upwards and converge at the upper support element 602. Viewed from the rear, the legs form an inverted U-shape and constitute a two-legged first spacer 606. The other ends of the legs extend forwards to the end of the open ring to form a second spacer 606. Under external force, e.g., from bruxism, the two ends of the open ring come into contact and thus act like a spring, increasing wearing comfort. To ensure that the retaining device 608 sits firmly in the dental arch, the device 600 can be custom-made to fit the individual user.

[0392] The advantage of such a design is that the device 600 can be additionally held in the intended position by a retention device 608. This prevents movement of the device 600 in the mouth and makes it more difficult to unintentionally remove the device 600, for example, while half asleep. Furthermore, the device 600 can also function as a retainer if it is shaped appropriately. Moreover, the implementation of the retention device is not limited to this embodiment but can be extended to other embodiments. Figures 7a to 7c show a device 700 according to a seventh embodiment. The device 700 according to the seventh embodiment differs from the device 600 in that the retention device 704 additionally extends over the outer surface of the lower dental arch. In other embodiments, the outer surfaces of the upper dental arch would also be possible.Such a design is particularly advantageous if, for example, a permanent retainer or brackets are already attached to the inner surface of the lower dental arch, or if even stronger retention against unintentional removal is required. The description of the other components (e.g., the support element 702, the spacer 706) is similar to that of the sixth embodiment and is therefore omitted. Furthermore, the implementation of the retention device is not limited to this embodiment but can be extended to other embodiments. Additionally, this embodiment features a tongue retention mechanism due to its shape.

[0393] Figures 8a to 8d show a device 800 according to an eighth embodiment. The device 800 is designed for placement within the dental arches. The design of the upper support element 802 and the spacer 806 of the device 800 is similar to that of the device 700.

[0394] The device 800 is preferably designed for users who already wear a retainer 844 on the inner surface of their teeth. While the device 700 uses a metal wire that can be attached to the inner surface of the teeth, the device 800 has a lower support element 804 into which the tip of the tongue is inserted. A hook 842 is provided on the front of the lower support element 804. The hook 804 is designed to attach the device 800 to the retainer 844. Furthermore, it is always possible for the hook 842 to be attached at a location desired by the user. Moreover, the implementation of the hook is not limited to this embodiment but can be extended to other embodiments.

[0395] A device 900 according to a ninth embodiment is shown in Figures 9a to 9d. As with the device 800 in Figure 8, the device 900 is also designed for placement within the dental arches. The device 900 is designed to sit comfortably and stably in the oral cavity. Thus, the device 900 can have streamlined outer surfaces at all or most points, characterized by a smooth, flowing curve without sharp or angular edges.

[0396] The basic shape of the upper and lower support elements 902 and 904 can follow the anatomy of the oral cavity, which can contribute to greater wearing comfort. For example, the upper surface of the device 900, as shown in Fig. 9b, has a curved shape to adapt to the palate. Fig. 9c shows the upper surface of the device 900, which is optimally adapted to the shape of the mouth.

[0397] Device 900 can also be manufactured with minimal material, for example, with a maximum wall thickness of 1 to 3 mm and by omitting material in non-load-bearing areas to increase wearing comfort and reduce production costs. Device 900 according to the ninth embodiment has four spacers 906. The spacers 906 are arranged at four corners of the device 900 so that the tongue can remain in a relaxed, natural position. It is understood that the number of spacers can vary depending on the specific circumstances. Furthermore, the goal of material savings and the described advantageous wall thicknesses can also be applied to all other embodiments described herein.

[0398] Figures 10a to 10c show a device 1000 according to a tenth embodiment. As with the device 900 in Figure 9, the device 900 is also designed for placement within the dental arches. The device 1000 is designed with two surface-minimized upper support elements and two surface-minimized lower support elements, together with a U-shaped recess for accommodating the lingual frenulum, which reduces the contact points with the body and increases wearing comfort.

[0399] Figures 11a to 11c show a device 1100 according to an eleventh embodiment. As with the device 1000 in Figure 10, the device 1100 is also designed for placement within the dental arches. The essential difference lies in the arc-shaped additional plug connections in the form of several horizontally stacked spacers 1106, which allow for individual height adjustment. Figures 12a to 12c show a device 1200 according to a twelfth embodiment. As with the device 1100 in Figure 11, the device 1200 is also designed for placement within the dental arches. The essential difference lies in the design of the front lower support element, which allows the tip of the tongue to be accommodated.

[0400] Figures 13a to 13c show a device 1300 according to a thirteenth embodiment. As with device 1200, device 1300 is also designed for placement within the dental arches. Analogous to device 1200, device 1300 essentially comprises rounded shapes. Device 1300 has two helical rods. The helical shape is a three-dimensional (3D) geometric form characterized by a smooth, continuous curve. The shape is similar to a spiral, but it does not extend in a plane, but rather in 3D space.

[0401] The helical shape of each rod begins with a smaller diameter at the base 1320, which also serves as the central support element, and gradually widens to a larger diameter as it extends outwards (left or right). This results in a conical spiral that winds around a central axis in 3D space, forming a tapered shape with an increasing radius. The left and right rods are designed symmetrically to each other so that their bases 1320 meet in the center of the device 1300.

[0402] Figure 13b shows that the helical shape begins at the base 1320 and extends slowly upwards, forming an upper support element 1302. The helical shape then extends slowly downwards, forming a lower support element 1304. The section between the upper and lower support elements is the spacer 1306. The helical shape terminates at the lower support element 1304. Specifically, the section 1304 does not continue to curve but runs essentially horizontally, forming a straight (flat) end.

[0403] The left and right helical rods are connected at the base and the central support element 1320, respectively. The bases 1320 can be connected directly, as shown in Fig. 13c, or connected via a connecting part 1318, as shown in Fig. 13a.

[0404] Furthermore, the rods can have a multitude of through holes 1316. These through holes 1316 serve, on the one hand, to improve saliva flow, and on the other hand, to allow for individual adjustment of the device 1300 (described later). The through holes 1316 can be distributed essentially uniformly along the length of the rod. They can also be provided only at specific locations. Even if not all of the illustrated embodiments have through holes 1316, it is well known to those skilled in the art that the concept of through holes described here and below can be advantageously applied to all described embodiments.

[0405] The helical shape allows for optimal adaptation to the contours of the mouth, ensuring comfort and functionality while wearing.

[0406] Figures 14a to 14c show a set 1400 according to a fourteenth embodiment. The set 1400 comprises a device 1500 and three connecting rings 1448 for connecting the lower support element 1404 of the device 1500 to a removable toothed splint 1446. In other embodiments, a connection of an upper support element to an upper toothed splint is also possible. The toothed splint 1446 can be a splint that the user already possesses due to other dental conditions. However, it can also be that the toothed splint 1446 is specifically designed to attach the device 1500 to the dental arch. The device 1500 looks similar to the device 900. However, this is only an example; that is, the set 1400 can also include devices that are shown in other embodiments and not in Figure 14.

[0407] The connecting ring 1448 has a circular or oval shape and is designed to connect the device 1500 and the toothed rail 1446, the ring forming a closed loop that can be opened and closed by a locking mechanism. The connecting ring 1448 can be inserted into the interdental space. For example, the connecting ring 1448 can be made of stainless steel wire with a diameter of 0.5 mm to 2.0 mm.

[0408] Typically, three rings can be provided, located on the front, left, and right sides of the 1500 device. However, it is also possible to use only one or two rings. The number of rings is not limited and depends on the specific requirements.

[0409] In this embodiment, the connecting ring does not pass through the device 1500 and the dental splint 1446, but rather surrounds or encloses them. Such a connection forms a closed loop around the parts and holds them together without the connecting ring having to pass through either part. Attaching the device 1500 to a splint reduces the risk of the device being inadvertently removed, for example, during sleep. In this embodiment, the device must be made approximately the height of the splint material on the teeth. In practice, this is often 1–7 mm. Due to the additional height, despite the extra splint material, the splint (and underlying teeth) on one side of the jaw and the teeth on the other side of the jaw (with splint material possibly also covering the occlusal surfaces) do not touch. The embodiment shown in Fig.The 14-fold device has the advantage that it can be attached to various rails available on the market without requiring any changes to their design and thus their medical device approval. In a preferred embodiment, the form-fitting connection is usable with the various rail types available on the market.

[0410] Figures 15a and 15b show a set 1600 according to a fifteenth embodiment. The set 1600 comprises a device 1700 and three connecting rings 1648 for connecting the lower support element 1604 of the device 1600 to a removable toothed rail 1636.

[0411] Set 1600 according to the fifteenth embodiment differs from set 1400 in that the connecting ring 1648 penetrates the dental splint 1636. For this purpose, a plurality of connecting holes 1650 are provided on the dental splint 1636. Such a design prevents the connecting ring from being inserted into the interdental space and is particularly suitable for users with sensitive gums.

[0412] Figures 16a and 16b show a set 1800 according to a sixteenth embodiment. The set 1800 comprises a device 1900 and three insertion pins 1854 for connecting the device 1900 to a removable tooth rail 1846. The device 1900 is similar in appearance to the device 1700. This design offers increased security against unintentional removal—firstly, due to the fastening itself, and secondly, because even if the device 1900 is unintentionally removed, the rail 1846 can still reduce tooth wear. However, this is only an example; that is, the set can also include devices shown in other embodiments.

[0413] Figures 17a to 17d show a set 2000 according to a seventeenth embodiment. The set 2000 comprises a device 2100 and a locking device for connecting the device 2100 to a removable toothed rail 2046. Two corresponding bores can be provided, one in the device 2100 and one in the toothed rail 2046. The alignment of the bores allows the penetrating pin 2054 to penetrate both bores, thereby holding the device 2100 and the toothed rail 2046 together and fixing their position relative to each other. The penetrating pin 2054 includes a stop (retaining collar) at one end to prevent loosening after penetration. The locking device 2052 is attached to the other end of the penetrating pin 2054 after the penetrating pin 2054 has penetrated the toothed rail 2046 and the device 2100. The design of the seventeenth embodiment allows for easy handling of the joining process.Although the bores in this embodiment are located on the front of the device 2100, they can of course also be located at other points on the device 2100.

[0414] Figures 18a to 18c show an eighteenth embodiment in which the device 2200 is connected to the rail 2246 by a permanent material bond. This design has the advantage that no small parts need to be connected or can enter the oral cavity, and that the device always has the same shape and position in the oral cavity, thus facilitating daily use.

[0415] Figures 19a to 19c show an adjustment device 2300 for the devices shown in the preceding embodiments. The adjustment device 2300 serves either to provide the user with mechanically induced biofeedback during mandibular movement, to increase wearing comfort by changing the shape, or to ensure proper spacing. The adjustment device does not require a splint as a base and can be used in multiple configurations at suitable locations (for example, on the tongue, the floor of the mouth, or the palate). Possible attachment locations on an exemplary embodiment are shown in Figure 19. The adjustment devices can be designed to be interchangeable.This interchangeability allows for a suitable adaptation in every usage cycle (for example, no adjustment device when distractions due to an important appointment are undesirable, or a larger and therefore more noticeable adjustment device when a conscious understanding of jaw movement is the goal). Changing the position of the adjustment device, as well as changing its size, can also reduce or prevent irritation. The 2300 adjustment device has a hemispherical upper part 2302 and a cylindrical lower part 2304. Parts 2302 and 2304 are connected to form a continuous structure.

[0416] The height ranges from a few tenths of a millimeter to a few millimeters.

[0417] The lower part 2304 is designed to be inserted, or in particular screwed, into a hole in the upper support element of the device (Fig. 19c or all other embodiments), the hole for fixing the adjusting device 2300 having a slightly smaller diameter than the lower part 2304. The diameter of the upper part 2302 is larger than the width of the lower part 2304, which limits the insertion depth so that the adjusting device 2300 remains securely positioned at the desired insertion depth. Figs. 20a to 20c show a variant 2400 of the adjusting device. The adjusting device 2400 differs from the adjusting device 2300 in that it also has a threaded nut 2406. The threaded nut 2406 is screwed onto a thread on the lower part 2404 of the adjusting device 2400 to fasten the adjusting device 2400 to the devices.During assembly, the lower part 2404 of the adjustment device 2400 is first inserted into a hole in the device, preferably into the upper or lower support element. The threaded nut is then screwed on to fix the adjustment device 2400 in place. The adjustment device 2400 provides a reliable connection. Preferably, the appropriately short lower part 2404 does not protrude beyond the threaded nut after fastening, in order to increase wearing comfort.

[0418] Further variants of the adjustment device 2400 are shown in Figures 21a, 21b, 22a, and 22b. Figures 21a and 21b show an adjustment device with a flattened, spherical upper part. Figures 22a and 22b show an adjustment device with a spindle-shaped upper part. Further variants of the adjustment device are shown in Figures 23a, 23b, 24a, and 24b. Figures 23a, 23b, 24a, and 24b show adjustment devices with flatter cylindrical upper parts, the upper part of the adjustment devices according to Figures 23a and 23b being shorter than the upper part of the adjustment devices according to Figures 24a and 24b. The different heights of the upper parts offer different adjustment possibilities. Figures 25a, 25b, 26a, 26b and 27a, 27b, 28a, 28b show further variants of the adaptation device 2400. The adaptation devices shown have conical upper parts.

[0419] Figures 29a to 29e show another adapter 2500. The adapter 2500 consists of an upper part 2502 and a lower part 2504, the end of which has a horizontally extending cylindrical base. The upper part 2502 and the lower part 2504 are connected by a rod and form a single-piece structure. The cylindrical base is designed for insertion into a corresponding slot 2510 of a coupling piece 2506, where it forms a bayonet coupling (Figure 29d). The bayonet coupling is a mechanical connection that creates a secure and releasable connection with the coupling piece 2506 by inserting and then rotating the adapter 2500 through a specific angle, preferably 90 degrees (Figure 29d). The coupling piece 2506 has a mounting plate 2512 provided with the slot 2510 and a pipe clamp 2508 equipped below the mounting plate 2512.The pipe clamp 2508 is designed to be securely connected to a cylindrical object placed on its surface. This allows the height of the device to be individually and reliably adjusted and / or the device to be used for generating biofeedback.

[0420] Figs. 30a, 30b, 31a, 31b, 32a, 32b, 33a and 33b show further variants of the adaptation device 2500, wherein the surface of the adaptation devices is designed to be so uneven that biofeedback is generated despite the low height when a force is generated by the movement of the lower jaw.

[0421] Figures 34a to 34e show another adaptation device 2600. The adaptation device 2600 differs from the adaptation device 2400 in that it has a horizontally extending upper part 2602 and two or more lower parts (clamping parts) 2604 for fastening the upper part 2602. This allows for greater shape adaptation while maintaining stable fastening.

[0422] Figures 35a to 35e show a variant 2700 of the adjustment device 2600. The adjustment device 2700 differs from the adjustment device 2400 in that the upper part 2702 has the shape of a curved, elongated oval. Analogous to Figure 20, it is screwed onto a thread 2704 on the lower part of the adjustment device 2700 using the threaded nut 2706 to attach the adjustment device 2700 to the devices. The curved shape allows for better adaptation to the oral cavity. The adjustment device 2700 serves to adjust the height of the devices, since each user may have a different oral cavity anatomy, e.g., the shape of the palate, the size of the tongue, and the general configuration of the jaw. It is preferably attached to the upper, middle, or lower support element. Figures 36a to 36c show a device 2800 according to a nineteenth embodiment. As with the device 1300 in Figure 36a, the following applies:Figure 13 shows that the device 2800 is also designed for placement within the dental arches. Figure 36a shows two unmounted upper support elements 2802 with different heights, as well as the mounting base with the plug connections 2806. Figure 36b shows a mounted upper support element 2802, which allows for a greater height than the mounted support element in Figure 36c. This design allows for individual height adjustment.

[0423] Figures 37a to 37c show a device 2900 according to a twentieth embodiment. As with the device 2800 in Figure 36, the device 2900 is also designed for placement within the dental arches. In this embodiment, the adjusting device 2902 is shaped like a clamp, i.e., it enlarges the upper support element 2906 both upwards and downwards. This is particularly suitable for users with a low tongue height, since, after the enlargement, the force generated by the mandibular movement acts not only on the floor of the mouth but also on the tongue, and by shifting the force generated by the mandibular movement to the tongue, irritations and injuries to the floor of the mouth are reduced.

[0424] Figures 38a to 38c show a device 3000 according to a twenty-first embodiment. As with the device 2900 in Figure 37, the device 3000 is also designed for placement within the dental arches. The device itself is similar to the device 2900, with the difference that an adapting device 3002 is attached to the posterior upper support element, thus acting as a new support element. The slightly curved shape of the adapting device 3002 is adapted to the shape of the palate. Wearing comfort is further increased by the spring effect provided by the material thickness and the design.

[0425] Figures 39a to 39c show a device 3100 according to a twenty-second embodiment. As with the device 3000 in Figure 38, the device 3100 is also designed for placement within the dental arches. The difference from device 3000 is that the interchangeable adjustment device 3102 is attached to the anterior (i.e., the part closest to the mouth) upper support element. The adjustment device 3102, which can be attached both anteriorly and posteriorly, allows for greater flexibility in adapting to individual anatomy and can also reduce irritation and pain.

[0426] Figures 40a to 40c show a device 3200 according to a twenty-third embodiment. As with the device 3100 in Figure 39, the device 3200 is also designed for placement within the dental arches. The device 3200 is similar to the device 2900, except that the adapting device 3202 in this embodiment is designed as a hookable support surface. This means that this adapting device only extends the upper support element 2906 upwards. This is particularly suitable for users with a large, especially high, tongue, for whom sufficient space for the tongue remains in this design.

[0427] Figures 41a to 41c show a device 3300 according to a twenty-fourth embodiment. As with the device 3200 in Figure 40, the device 3300 is also designed for placement within the dental arches. The device 3300 is similar to the device 3200, with the difference that, in this embodiment, the adapting device 3302 is inserted laterally into the two openings 3306 and fixed there with two pins. This design is optimal for oral cavities with a low palatal height and users with a large tongue. The adapting device can also be attached at other locations (for example, on the anterior upper support element) and have a different shape (for example, be narrower or taller), as in other embodiments.

[0428] Figures 42a and 42b show a device 3400 according to a twenty-fifth embodiment. As with the device 3300 in Figure 41, the device 3400 is also designed for placement within the dental arches. Here, the adaptation device is inserted horizontally into the device 3400 to widen the device 3400, thus creating more space for the tongue and optimizing its position in the oral cavity. The adaptation devices—as in other embodiments—can also be attached at other locations (for example, on the rear part of the device) and have a different shape (for example, be wider or taller to allow a precise fit against the device). The lower and upper parts 3402 are designed to be inserted into a hole 3406 in the lower and middle support element of the device (Figure 42b or all other embodiments).In particular, it is to be screwed in, with the holes for fixing the adjusting device 3406 having a slightly smaller diameter than the central part 3404. This allows the insertion depth to be limited so that the adjusting device remains securely positioned at the desired insertion depth.

[0429] Figures 43a to 43c show a device 3500 according to a twenty-sixth embodiment. As with the device 3400 in Figure 42, the device 3500 is also designed for placement within the dental arches. Figures 43a, 43b, and 43c show perspective, front, and top views of the device 3500. The device 3500 begins at the front with a flat base forming the two lower support elements 3504 and extends symmetrically to the rear, top, left, and right. The lateral and upward-extending parts together form a spacer 3406 and create an arc-like structure, generating a space between the lateral and upward-extending parts for receiving the tongue.

[0430] The three-directional extension creates a wide, encompassing shape that terminates at an upper support element 3502. Furthermore, this shape allows for convenient placement of the tongue, ensuring the device remains in its intended position even with the tongue in place.

[0431] Preferably, the device 3500 can include a biological feedback mechanism. The biological feedback mechanism, also known as biofeedback, is a method, particularly a therapeutic method, for treating mental and physical illnesses, in which people learn to consciously control and regulate their physiological processes. The aim is for people to learn to consciously perceive and influence unconsciously occurring processes in their own bodies, such as heart rate, blood pressure, sweat gland activity, and brain waves. The goal is to gain control over normally unconscious bodily processes through this feedback in order to improve health and well-being. Within the scope of this disclosure, biofeedback is used in particular for the treatment of bruxism.

[0432] It should be particularly emphasized at this point that the biofeedback function can be implemented not only in this embodiment, but in all embodiments of the present invention.

[0433] In the device 3500, a snap disc is used to generate biofeedback. The snap disc consists of a slightly curved metal plate 3564, which can be embedded in a larger metallic structure. This snap disc is inserted into a housing 3566 and thus secured. In this embodiment, the metal plate 3564 has two holes 3568 through which two fastening pins 3569, fixed to the device, are guided to prevent the snap disc from slipping out of the housing 3566. The housing 3566 is rigidly connected to the spacer 3506, creating a flexible or cantilever-like structure (see Fig. 43d). The connection of the housing 3566 is designed so that it can bend without detaching from the spacer 3506. At the upper end of the device 3500 is a dome-shaped part 3502, which slopes downwards outwards.The curved part 3502 is designed to deform once a certain degree of mandibular movement is reached, thereby exerting force on the snap disc. When a certain degree of mandibular movement is exceeded, for example, triggered by bruxism, the snap disc deforms or moves downwards, producing an audible "click" and / or vibration (Fig. 43e). This, along with the changing shape of the device, indicates to the user that the mandible is moving and exerting force on the device. When the force exerted by the mandibular movement ceases, the curved part 3502 and the snap disc spring back to their initial position. During this return, the snap disc produces another snapping sound and / or vibration, which, together with the device's return to its original shape, indicates to the user that the mandible has returned to a relaxed position.The snap disc can consist of a thin disc made of a high-strength material, such as 316L surgical stainless steel or titanium. The dome's shape allows it to bend and return to its original form, thus providing a reliable and repeatable mechanism for generating an audible and / or tactile signal.

[0434] The device – as in other embodiments – can also have a different shape: The shape of device 3400 can be further simplified (not shown) by shaping the spacer into a sphere or hemisphere (with the flat end resting on the tongue) between the palate and tongue. In this spherical or hemisphere shape without a tongue holder, it is crucial that the permanent positioning is ensured (for example, by means of wires or the embodiments already shown in the set). The snap disc and its holder can also be attached at other points (for example, on the lower support element).

[0435] It is particularly important to emphasize that the biofeedback function of the snap disc can be implemented not only in this embodiment, but in all embodiments of the present invention that were shown without a snap disc. In both this and other embodiments, a coil spring can be provided in the device (in this embodiment, for example, in the fastening pins 3569), which, for example, reduces excessive pressure on the snap disc and thus lowers the risk of damage or increases wearing comfort.

[0436] The biofeedback function according to the twenty-sixth embodiment is realized by a simple mechanism that eliminates the need for a battery; this is particularly advantageous for products used in the mouth, as it saves space, reduces the risk of injury, and enables uncomplicated continuous use.

[0437] With a splint, the immediate trigger is the force, and any prior mandibular movement is largely irrelevant for a splint solution (partly because the teeth are immobile). One of the key advantages of a spacer compared to splints is that the force generated by the mandibular movement acts on the spacer earlier and not on the occlusal surfaces. In the case of biofeedback via a snap disc, the immediate trigger for the snap disc is the mandibular movement (which, in a second step, triggers a force) and not the force at the end of the mandibular movement. The snap disc only deforms during movement and only when the force exceeds a threshold. This means the present invention has an earlier trigger (namely, the movement) and occurs before the occlusal surfaces experience the force (the spacer is intended to prevent the force from acting on the occlusal surfaces).

[0438] The modified basic design due to the spacer, compared to the splint, allows, for example, an early spring effect or early biofeedback based on mandibular movement - the user of the spacer has already received biofeedback when the same user of a splint in an identical situation has not yet received any information about a bruxism event despite the biofeedback mechanism.

[0439] Figures 44a to 44c show a device 3600 according to a twenty-seventh embodiment. As with the device 3500 in Figure 43, the device 3600 is also designed for placement within the dental arches. In device 3600, the upper support element 3602 is provided with a hinge 3668 on the front ring. This hinge reduces the risk of fatigue fractures and also allows for individual adaptation to individual users by means of different heights and shapes of the support elements. The snap disc 3664 is inserted into the housing through a slot 3666 at the rear end. The upper support element 3602 is designed to move downwards during a relative movement of the upper and lower jaw and exerts force on the snap disc 3664 by means of the pin 3672. If a threshold value of the mandibular movement, e.g., triggered by bruxism, is exceeded, the upper support element 3602 deforms or...The snap disc 3664 moves downwards, producing an audible "click" and / or a vibration. The snap disc and its holder can also be attached at other locations (for example, on the front part of the device), as in other embodiments.

[0440] Figures 45a to 45e show a device 3700 according to a twenty-eighth embodiment. As with the device 3600 in Figure 44, the device 3700 is also designed for placement within the dental arches. The embodiment, including the snap disc, consists of four parts, with the upper support element that holds the snap disc comprising two parts. The snap disc is additionally secured by two pins 3769 in both the front part 3702 (as seen from the mouth) and the rear part 3766. When the palate presses on and displaces the upper support surface due to the relative movement of the upper and lower jaws, e.g., triggered by bruxism, the snap disc is pressed against the rear spacer 3706 within its housing and deforms between the front and rear parts of the support element, thus producing an audible "click" and / or a vibration (Figure 43e).The snap disc and its holder can also be attached in other locations – as in other embodiments – (for example, on the front part of the device).

[0441] Figures 46a to 46f show a device 3800 according to a twenty-ninth embodiment. As with the device 3700 in Figure 45, the device 3800 is also designed for placement within the dental arches. As in device 3700, the snap disc 3864 is mounted in the upper support element 3802, which, however, is a single piece. The clicking and / or vibration in this embodiment is triggered when the upper support element 3802 moves downwards due to the relative movement of the upper and lower jaws, for example, caused by bruxism, and the snap disc 3864 strikes the pin 3872. The snap disc and its holder can also be attached at other locations (for example, on the front part of the device), as in other embodiments.

[0442] Figures 47a to 47c show a device 3900 according to a thirtieth embodiment. As with the device 3800 in Figure 46, the device 3900 is also designed for placement within the dental arches. As in device 3800, the snap disc 3964 is mounted in the upper support element 3902, which, however, is in two parts. Here, the snap disc clicks / vibrates when the upper support element is pressed against the anterior (i.e., closer to the mouth) spacer 3906 by the relative movement of the upper and lower jaws. The snap disc and its holder can also be attached at other locations (for example, on the front part of the device), as in other embodiments. Figures 48a to 48c show a device 4000 according to a thirty-first embodiment. As with the device 3900 in Figure 47, the device 4000 is also designed for placement within the dental arches.Device 4000 differs from device 3900 in that it has only two rear spacers 4006. The movement of the lower jaw, for example triggered by bruxism, moves the upper support element 4002, which is attached to a hinge 4068, downwards, where it contacts the front part of the housing 4066 of the snap disc 4064. With further movement, the snap disc 4064 deforms, generating sound and / or vibration. The snap disc and its mounting can also be attached at other locations (for example, at mid-height of the device), as in other embodiments.

[0443] Figures 49a to 49c show a device 4100 according to a thirty-second embodiment. As with the device 4000 in Figure 48, the device 4100 is also designed for placement within the dental arches. Device 4100 is characterized by a ball joint 4168 that individually optimizes the position of the upper support element 4102 on the palate. The upper support element encloses the snap disc on its underside. The snap disc 4164 is additionally enclosed by two housings 4166. The movement of the mandible, which moves the upper support element, presses the snap disc and generates sound and / or vibration.The snap disc and its holder can be attached at other locations (for example, at mid-height of the device), as in other embodiments, and the snap disc holders can be misaligned (as in other embodiments) to create a preload and accelerate or decelerate the triggering moment. Two snap discs rotated 180 degrees opposite each other can be accommodated in the housing, so that both upward and downward movement trigger a sound and / or vibration, or amplifies the feedback.In addition, the device 4100 is characterized by two additional fastenings, one from above and one from below, on each side of the housing 4166: When the snap disc 4164 is inserted into the housing 4166, a pin 4172 from above and a pin 4174 from below on both the front and rear sides of the housing 4166 extend through a hole into the snap disc, preventing it from slipping. These pins can be released, should the snap disc 4164 need to be replaced, by applying force to the pin 4172 or 4174 – similar to opening a smartphone SIM card slot.

[0444] It should be particularly emphasized at this point that the fastening and fastening solution via pins, ball joints and the double snap disc inserted in opposite directions by 180 degrees can be implemented not only in this embodiment, but in all embodiments of the present invention as far as technically possible.

[0445] Figures 50a to 50c show a device 4200 according to a thirty-third embodiment. As with the device 4100 in Figure 49, the device 4200 is also designed for placement within the dental arches and has four spacers 4206 and a lower support element 4204. In contrast to the other embodiments, the snap disc 4264 is attached to the upper support element 4202 and fastened from above with two pins 4272 such that the mandibular movement acts from below on the housing 4266 to generate a tone and / or vibration via the snap disc 4264.

[0446] The snap disc and its holder can also be attached at other locations – as in other embodiments – (for example, at the middle height of the device or on the lower support element, such as on a front or rear spacer). In a preferred embodiment, sufficient space is provided for the tongue (for example, by means of an opening in the snap disc or two snap discs arranged parallel to the tongue).

[0447] Fig. 51 shows the physical principle and the state of the art based on it for the functioning of a snap disc.

[0448] Figures 52a and 52b show a device 4300 according to a thirty-fourth embodiment. As with the device 4200 in Figure 50, the device 4300 is also designed for placement within the dental arches. To implement a biofeedback function without a snap disc, at least one rod with a piezoelectric element 4322 can be provided in this embodiment (Figures 52a and 52b). For example, the piezoelectric element 4322 can be embedded in the section that experiences the greatest stress. The piezoelectric element can also be attached at other locations (for example, at the midpoint of the device or at the top). The piezoelectric element 4322 is a component made of or comprising a piezoelectric material. This material has the ability to convert mechanical deformation (such as compression, tension, or bending) into electrical charge and vice versa.The piezoelectric element 4322 uses this piezoelectric effect to convert mechanical energy into electrical energy.

[0449] In practice, the section where the piezoelectric element 4322 is located can be determined by analytical calculations, numerical calculations, or FEM simulations. Alternatively or additionally, this section can also be determined experimentally. For example, the piezoelectric element 4322 can be embedded in the spacer 4306. This is because, during bruxism, the spacer 4306 is subjected to the greatest stress due to the bending force on this part. The mandibular movement occurring during a bruxism event deforms the device 4300, i.e., the piezoelectric element 4322. This deformation generates an electric field in the piezoelectric element 4322; that is, the compression absorbed by the piezoelectric element 4322 is converted into electrical energy and can be used to warn of bruxism.

[0450] The warning can be in the form of acoustic, tactile, visual, or electrical feedback. For example, an electrode 4324 can be arranged on the device for electrical feedback. This allows the electrode 4324 to transmit a mild electrical stimulation to the user when a mandibular movement exceeds a certain threshold. The electrode 4324 can be attached to a location on the device 4300 that establishes reliable contact with the user during bruxism, such as on the outer surface of the lower support element 4304. Furthermore, it is also conceivable that the outer surface of the device 4300 (or at least a part of it) is made of conductive paint. The piezoelectric element 4322 can be made, for example, from flexible piezoelectric materials such as PVDF, PZT foil, piezoelectric elastomers or rigid piezoelectric materials such as PZT ceramic, quartz, lead zirconate titanate (PZT) and lead magnesium niobate (PMN).

[0451] Figs. 53a and 53b show the physical principle of a piezoelectric device.

[0452] Figures 54a to 54d show a device 4400 according to a thirty-fifth embodiment. As with the device 4300 in Figure 52, the device 4400 is also designed for placement within the dental arches. Due to its piezoelectricity, a battery-powered biofeedback system is unnecessary, which significantly reduces the size and weight of the device 4400. However, a battery could preferably be included to perform other functions.

[0453] The device 4400 is a truss structure (frame) characterized by two inverted U-shapes visible from the front and rear, and two upright U-shaped elements visible from the left and right.

[0454] The legs of the inverted U-shapes are connected at the bottom to form a stable lower support element 4404. An upper support element 4402 rests on two arcs of the inverted U-shapes. The rear part of the upper support element 4402 is connected to the arc of the rear inverted U-shape, and the front part of the upper support element 4402 is spaced apart from the arc of the front inverted U-shape when unloaded (Fig. 54a). It should be noted that the front and rear directions refer to a functional and proper orientation when worn in the mouth. The legs of the inverted U-shapes are designed as spacers 4406.

[0455] The device 4400 can also be equipped with a biofeedback function, whereby the essential components of the biofeedback system can be housed in the upper support element 4402 or, in other embodiments, elsewhere. Fig. 54c shows the internal perspective of the upper support element 4402 without the cover. A battery 4428, a microcontroller 4430, and a vibration element with a buzzing device 4432 are visible in the support element 4402. The battery 4428 supplies power to the vibrator with buzzing device 4432 and the microcontroller 4430.

[0456] The vibrating element with buzzer alerts the user through a vibration signal and a buzzing sound. To allow different users to select their preferred warning method, all warning methods can be integrated into the 4400 device. Alternatively, to save costs, only one method can be offered.

[0457] During mandibular movement, particularly in bruxism, the first contact point 4434 of the anterior part of the upper support element 4402 contacts the second contact point 4436 of the arc of the anterior inverted U-shape (Fig. 54b). The two contact points 4434 and 4436 can be made of conductive material (e.g., gold) so that when they meet, an electrical circuit embedded in the device 4400 (not shown) is closed, generating biofeedback such as vibration and / or buzzing.

[0458] To generate reliable biofeedback, it is advantageous that the two contact points 4434 and 4436 are provided at locations on the device 4400 that overlap with the sagittal plane of the device 4400.

[0459] To achieve optimal performance, it is advantageous that the upper support element 4402 and the frame are designed as an integral hinge, with the selected material offering sufficient resistance or the free ends only meeting during a mandibular movement induced by bruxism.

[0460] The number of microcontrollers 4430 and / or batteries 4428, and the type and quantity of biofeedback devices, can be adjusted as needed. The batteries 4428 power the microcontroller 4430 and any other components. To comply with various medical device regulations, it may be preferable for the upper support element 4402 to be constructed as a single piece and completely impermeable, thus securely enclosing all components. The components can only be removed if the support element is damaged.

[0461] In general, the device, in all its embodiments, can be used without medical personnel and can also be customized or adapted without medical personnel via standardized size ranges or adjustment devices. In the case of unusual anatomy requiring further customization, the adjustment devices are designed so that they can be easily replaced or manufactured by the user, who is not a medical professional. This excludes dental applications in sets and the production of customized individual pieces, which may require medical personnel.

[0462] The material of the preceding devices or adjustment devices is preferably biocompatible, for example PA 2200 or PA12, KeySplint Soft, or 316L stainless steel, wherein the device according to the invention can consist of one or more of these materials. Furthermore, the material can be adaptable, e.g., under the influence of heat or force, so that individual adaptation to the user's oral cavity is possible. The surface material can be soft, for example, created by a silicone bath or by spraying on silicone to avoid irritation in the mouth. Individual adaptability can be achieved, for example, with a two-component paste or a thermally permanently deformable thermoplastic and other deformable materials that harden under the influence of visible light, radiation, temperature, or by other means to assume a permanent individual shape.

[0463] Crucially, and regardless of the type and number of materials used, the material composition, in conjunction with the chosen shape, ensures the required spacing and thus avoids or reduces contact forces on the occlusal surfaces to such an extent that no damage occurs. The embodiments described here serve only to illustrate the invention. It is understood that the specific features disclosed in a particular embodiment can be integrated into other embodiments, provided such integration is technically feasible. Therefore, the invention should not be limited to a specific embodiment but should be interpreted in accordance with the appended claims and their corresponding versions.

[0464] Figures 55a to 55f show a thirty-sixth embodiment of the device 4500 in front view, left side view, right side view, bottom view, top view, and cross-section. The device 4500 is essentially designed for placement within the dental arches, being attached to the occlusal surfaces and to both sides of the teeth of the lower jaw.

[0465] The device 4500 comprises an upper support element 4502 for placement on the palate and a lower support element 4504 for placement on the teeth of the lower jaw. A spacer 4506 is provided between the upper support element 4502 and the lower support element 4504. In this embodiment, the contact section of the lower support element is individually adapted to each user and their tooth shape and extends on and alongside the teeth of the lower jaw. The contact section of the lower support element is shaped via a cavity such that the position of the tongue in its resting position changes only minimally. In this embodiment, the spacer and the lower support element are manufactured as a single piece and thus made of only one material in order to save production costs.The retention section of the lower support element features a non-elastic retention plate that extends along the edge of the occlusal surfaces and around the tongue. This plate has the shape of an elliptically pronounced quarter-sphere and is permanently connected to the spacer and the contact section of the lower support element. The spacer extends upwards and forwards in the oral cavity at its upper end. The spacer and the upper support element together form a rotationally symmetrical joint structure, with the spacer designed as a cylindrical element and the upper support element as its corresponding receptacle. The receptacle is an open three-quarter circle, allowing the connection to be established under force and heat. The upper support element 4502 is specifically adapted to the user's palate shape.The snap disc 4564 is mounted in the upper support element 4502, such that the upper support element 4502 forms a protective housing around the snap disc 4564. The spacer 4506, which is designed as a single-axis joint, has a contact surface through which the snap disc 4564 is deformed and triggered by pressure exerted by the contact surface 4572. Upon reaching a predetermined threshold of jaw movement force, the snap disc exhibits a distinct switching behavior, transitioning from one state to another and returning to its original state when the force falls below a predetermined threshold. The snap disc 4564 is designed to generate acoustic and tactile feedback.

[0466] Figures 56a to 56f show a thirty-seventh embodiment of the device 4600 in front view, left side view, right side view, bottom view, top view, and cross-section. The device 4600 is essentially designed for placement within the dental arches, being attached to the occlusal surfaces and to both sides of the teeth of the lower jaw.

[0467] The device 4600 comprises an upper support element 4602 for placement on the palate and a lower support element 4604 for placement on the teeth of the lower jaw. A spacer 4606 is provided between the upper support element 4602 and the lower support element 4604. In this embodiment, the contact section of the lower support element 4604 is not individually adapted to a single user and their tooth shape. The adaptability for different users is also achieved by the fact that the lower support element is partially designed as a dental splint and is made of a thermoplastic, dimensionally stable, and resilient material that is not soft in the sense of silicone and covers some teeth of the left and right sides of the jaw.The interdental spaces in front of, between, and / or behind these teeth are filled with longitudinal strips of a thermoplastic material to enable a form-fit and / or force-fit anchorage to the teeth and adjustability without medical personnel. Depending on the user's tooth position, these longitudinal strips can also serve as attachment elements for securing the device to several teeth of the lower jaw – the position of the interdental spaces can vary from user to user. The spacer 4606 is shaped to form a cavity, minimizing changes in the tongue's resting position. Not shown in the drawing, but part of the device in this embodiment, are two screws that are inserted from above, first into the spacer 4606, then the retaining plate 4698, then back into the spacer 4606, and finally into the lower support element, temporarily fastening these parts together.In this embodiment, the retaining section of the lower support element has an inelastic retaining plate 4698, which extends in a semicircle along the edge of or on the occlusal surfaces and around the tongue. This plate is temporarily connected to the spacer 4606 and the contact section of the lower support element 4694 by means of two screws to partially or completely absorb the force generated by mandibular movement. The retaining plate 4698 is made of a dimensionally stable material that does not deform significantly under load and contributes to stabilizing and securing the device 4600 in the oral cavity. The screws serve as connecting elements.The retaining plate 4698 is designed to additionally secure the spacer against unintentional falling out and / or asymmetrical and / or faulty or unstable positioning within a recess. In conjunction with the two screws—the nut being threaded in the retaining plate 4698—it enables a positive and / or force-fit fixation, whereby the retaining plate is secured by the surrounding support element in conjunction with the through-bolt. The retaining plate 4698 has recesses on the left and right rear sides for a positive-fit connection to accommodate the spacer 4606. This fixation by two screws secures the spacer 4606 against unintentional falling out and / or asymmetrical positioning by means of an additional retaining element.The components can only be separated outside the oral cavity and only with the use of a tool. The lower section of the spacer runs essentially parallel to the lower support element, pointing away from the teeth into the interior of the oral cavity. The spacer has a change of direction between its lower end, which connects to the lower support element and the retention plate, and its upper end, which connects to the upper support element. The spacer starts in an inverted, rounded I-shape at the retention plate 4698. In a second section, the spacer 4606 extends straight upwards and forwards in the oral cavity at its upper end and is symmetrical from left to right. Due to the change of direction, the spacer is essentially perpendicular to both the lower and upper support elements.The supported arrangement of the spacer allows movement of the mandible relative to the maxilla in a left-right direction and / or in a forward-backward direction. In this embodiment, the spacer 4606 is made of a metal that prevents plastic deformation in at least one direction between the upper support element 4602 and the lower support element 4604 when force is exerted or movement is carried out by the mandible, particularly during a closing movement of the mandible or biting force. The gap created by the spacer reduces the force exerted on an occlusal surface or prevents direct contact between the occlusal surface of the maxilla and the lower support element. The upper support element and the spacer are connected to each other by the ball joint of the spacer.The upper support element comprises a hinge socket, the hinge socket having an entry opening with a diameter smaller than the diameter of the spacer end piece formed in the spacer in the form of a spherical element, so that the spacer end piece can be snapped into the hinge socket by force and / or heating of the support element, and the snap-in connection is designed to enable a joint function while simultaneously preventing unintentional release. The upper support element 4602 is not specifically adapted to the palate shape of the user and includes, as standard, a small indentation at the front for the incisive papilla. The snap disc 4664 is mounted in the upper support element 4602, so that the upper support element 4602 forms a protective housing around the snap disc 4664, preventing the snap disc from entering the oral cavity.The spacer 4606 has a contact surface through which the snap disc 4664 is deformed and triggered by pressure exerted by the contact surface 4672. Upon reaching a predetermined threshold of jaw movement force, the snap disc exhibits a distinct switching behavior, transitioning from one state to another and returning to its original state when the force falls below a predetermined threshold. The snap disc 4664 is designed to generate acoustic and tactile feedback. One possible embodiment of this device consists of a biocompatible stainless steel snap disc, a titanium spacer, and upper and lower support elements made of KeySplint Soft.The device in this embodiment is characterized by the fact that all points in contact with the body, particularly the soft tissues, as well as the overall shape of the device, are smooth and rounded, especially the surfaces adjacent to the tongue and palate. In this embodiment, the spacer is designed to be interchangeable in order to adapt the device to different mouth shapes, particularly different palate heights, whereby the interchangeability ensures a defined distance and simultaneously a closed mouth for all users.

[0468] Figures 57a to 57f show a thirty-eighth embodiment of the device 4700 in front view, left side view, right side view, bottom view, top view, and cross-section. The device 4700 is essentially designed for placement within the dental arches, being attached to the occlusal surfaces and to both sides of the teeth of the mandible.

[0469] The upper support element, which is also part of the device, is not shown. The device 4700 comprises an upper support element for attachment to the palate and a lower support element 4704 for attachment to the teeth of the lower jaw. The spacer 4706 is provided between the upper and lower support elements 4704. In this embodiment, the contact section of the lower support element 4704 is individually adapted to a single user and their tooth shape and extends on and alongside the teeth of the lower jaw. The contact section of the lower support element is shaped with a thin wall so that the position of the tongue in its resting position changes only slightly. The retention section of the lower support element has an inelastic retention plate 4798, which is inserted from the mouth side and extends over the occlusal surfaces of the anterior teeth.In another embodiment, the retaining plate 4798 could also be configured as a spacer washer. In yet another embodiment, in which the spacer washers shown in the drawing are no longer included, it could also be permanently connected to the spacer, possibly even integrally formed with the spacer. The retaining plate 4798 is temporarily connected to the spacer 4706 and the spacer washers 4780 by means of a screw 4790. To further secure the spacer 4706 against unintentional removal and / or asymmetrical and / or faulty or unstable positioning within a recess, it is designed such that, in conjunction with the screw 4790 (the thread is formed in the retaining plate), it enables a positive and / or force-fit fixing.The retaining plate 4798 is secured by the surrounding lower support element 4704 in conjunction with the through-bolt 4790. In this embodiment, three spacer washers 4780 are arranged between the spacer 4706 and the lower support element 4704. These washers are designed to selectively increase the vertical distance between the spacer 4706 and the lower support element 4704. The spacer 4706, the spacer washers 4780, and the lower support element 4704 are connected to each other by means of a common connecting element, in this case a screw 4790, in a force-fit, form-fit, and detachable manner. The spacer washers 4780 are designed to be interchangeable in order to adapt the device to different palatal heights. This interchangeability ensures a defined distance and a closed mouth for all users.The lower support element 4704 has recesses for the retention plate 4798 and material below and / or above the retention plate 4798 to partially or completely absorb the force generated by mandibular movement and simultaneously prevent or minimize direct contact between the teeth and the retention plate 4798. The retention plate 4798 is surrounded by an elastic material at points of potential tooth contact and is made of a material and shaped in a way that prevents damage to the enamel. The geometric design and material of the retention plate 4798 are intended to ensure a stable position even under asymmetrical loads. Furthermore, the retention plate 4798, the spacers 4780, and the spacer 4706 each have two recesses on the underside and two raised areas on the top to prevent these parts from shifting to the right or left under load.The spacer can be moved to the left. The side walls 4770, which are form-fitting to the spacer and the support elements, serve the same purpose, as does their triangular shape at the front, which secures the spacer 4706 against unintentional falling out and / or asymmetrical positioning. The spacer 4706 has a change of direction between a lower end, which is connected to the lower support element 4704, in particular the retaining plate 4798, and an upper end, which is connected to the upper support element. Specifically, in this embodiment, it undergoes a change of direction of approximately 100 degrees and a change of shape: cuboid in the lower section, round and circular and tapering in the transition to the middle section, straight and round in the middle, and spherical in the upper section, with its upper end extending upwards and forwards in the oral cavity.The spacer 4706 creates a gap that reduces the force exerted on an occlusal surface or prevents direct contact between an occlusal surface and the lower support element 4704. In this embodiment, the spacer 4706 is made of metal.

[0470] Figures 58a and 58b show a first embodiment of a two-part upper support element 4802, 58a showing the upper part from below and 58b showing the lower part from an oblique angle above. The upper support element 4802 is designed for placement within the dental arches. The upper support element is multi-part. The upper part contacts the palate. The lower part connects the support element to the spacer, which is designed as a ball joint. The lower part is designed to receive a snap disc. After the snap disc is inserted, the upper part is slid laterally onto the lower part until it locks into place. This secures the snap disc in a protective housing, which simultaneously serves as the upper support element, thus saving space.

[0471] Figures 59a and 59b show a second embodiment of a two-part upper support element 4902. Figure 59a shows the upper part from the side and Figure 59b shows the lower part from above. The upper support element 4902 is designed for placement within the dental arches. The upper support element is multi-part. The upper part contacts the palate. The lower part connects the support element to the spacer, which is designed as a ball joint. The lower part is designed to receive a snap disc. After the snap disc is inserted, the upper part is slid onto the lower part from above until it locks into place. This secures the snap disc in a protective housing, which simultaneously serves as the upper support element, thus saving space. The upper part is stable in the middle and flexible at the sides, which can increase wearing comfort. Figures 60a to 60c show a third embodiment of an upper support element in conjunction with a uniaxial joint.Figure 60a shows the upper support element from the side, figure 60b from the side below, and figure 60c from below.

[0472] The upper support element 5002 is designed for placement within the dental arches. The upper support element 5002 is pre-equipped to receive a snap disc and is connected to the spacer 5006, which is designed as a ball joint.

[0473] Between the upper support element 5002 and the spacer 5006, there is one degree of freedom of movement in the forward-backward direction. The upper support element 5002 comprises a socket joint, the socket having an entry opening with a diameter smaller than the diameter of a spherical spacer end formed in the spacer 5006, such that the spacer end is engaged in the socket joint by force and / or heating of the support element. The socket joint has an elastically designed locking lip that temporarily deforms outwards when the ball is inserted and, after the spacer end joint, for example the ball, springs back behind it and locks into place. The socket joint has a conically recessed inner contour that provides multi-point support for the ball to increase the holding force.The joint socket has a slot in the form of a semicircular ring segment, bounded by two spaced-apart circular arcs of identical curvature. This increases the elasticity of the socket and facilitates insertion and removal of the joint. The slot runs parallel to the mouth because a slot running towards the pharynx would more easily cause the joint to dislodge from the socket under load, rendering the device ineffective and posing health risks. The ball of the ball-and-socket joint has a flattened zone that engages in a corresponding groove in the joint socket, allowing the ball to rotate only around one axis within the socket.

Claims

Claims 1. Device for the treatment and / or prevention of and / or testing for bruxism and / or craniomandibular dysfunction (CMD) and / or its consequences, which is designed to be placed in the oral cavity, preferably between the upper and lower jaws, of a user, and which is designed to ensure a distance between an occlusal surface of the lower jaw and an occlusal surface of the upper jaw, the device comprising: an upper support element (102) designed to make contact with the palate, a lower support element (104) and a spacer connecting the upper support element and the lower support element, wherein the spacer (106) is designed to ensure the spacer is maintained under forces occurring in the oral cavity during use, characterized in that the spacer is offset from an occlusal surface between the upper and lower jaws and, in particular, within the dental arches.

2. Device according to claim 1, wherein the lower support element comprises a contact section for coming into contact with a part of the lower jaw and a retaining section for connection with the spacer.

3. Device according to claim 2, wherein the contact section of the lower support element comprises the following: one or more dental appliances placed in the oral cavity, in particular braces or splints, which may also comprise only one tooth and / or part of the dental arch, and / or one or more connecting means for temporarily or permanently connecting the device to one or more dental appliances, in particular braces or splints, which may also comprise only one tooth and / or part of the dental arch or a locking mechanism, wherein the connecting means may, for example, have a locking mechanism, a through hole and / or a thread, and / or one or more fastening elements for attaching the device to one or more teeth of the lower jaw or to other locations in the oral cavity.

4. Device according to claim 3, wherein the lower support element comprises one or more dental appliances, in particular dental splints, inserted into the oral cavity, which in particular consist of a thermoplastic, dimensionally stable and resilient material that is not soft in the sense of silicone, and cover at least one tooth of the left and right halves of the jaw, i.e. a total of at least two teeth, and / or fill the interdental spaces in front of, between and / or behind these teeth with a thermoplastic material, preferably in longitudinal strips, spherical shape, wedge shape or conical design along the interdental spaces, in order to enable a form-fit and / or force-fit anchorage to the teeth and an adjustability of the splint without medical personnel.

5. Device according to any one of the preceding claims 2 to 4, wherein the retaining section of the lower support element, which may, for example, have a quarter-sphere surface or a geometrically similar curved shape, in particular a spheroidal or elliptically curved surface in the area of ​​the tongue, has an inelastic retaining plate, which is preferably located at the edge of the or extends over the occlusal surfaces and around the tongue, particularly in the form of a semicircle, and is permanently or temporarily connected to the spacer and / or the contact section of the lower support element to partially or completely absorb the force generated by the movement of the mandible, wherein the retention plate is made of a dimensionally stable material which does not deform significantly under load and contributes to stabilizing and fixing the device in the oral cavity.

6. Device according to claim 5, wherein a support element is formed by recesses for the retention plate and material below and / or above the retention plate to partially or completely absorb the force generated by the mandibular movement and at the same time prevent or minimize direct contact of the teeth with the retention plate, wherein the retention plate is completely or partially encased or lined with an elastic material in those areas where direct tooth contact is possible – in particular in the area of ​​the occlusal surfaces and the vestibular and lingual sides – and / or consists of a material, for example PMMA, photopolymer resin, thermoplastic and / or dimensionally stable plastics, and / or a shape that prevents or minimizes damage to the tooth enamel, for example by an additional buffering cover element arranged between the retention plate and the tooth surface.and wherein the mounting plate, through its geometric design and choice of material, is designed to ensure a stable position even under asymmetrical loads.

7. Device according to one of the preceding claims, wherein the retaining plate is permanently or temporarily connected to a support element and / or the spacer, and / or wherein the retaining plate is designed to additionally secure the spacer against unintentional falling out and / or asymmetrical and / or faulty or unstable positioning within a recess, such that, in conjunction with at least one screw and a nut or a thread formed in the retaining plate and / or in the spacer, it enables a positive and / or force-fit fixing, wherein the nut or the thread is preferably arranged outside or in a recess of the lower support element and the retaining plate is secured by the surrounding support element in conjunction with the through-screw.

8. Device according to any one of the preceding claims 4 to 7, wherein a support element and / or the dental appliances and / or the retaining plate has one or more recesses for receiving the spacer, wherein the spacer may have a section with an external thread for screwing into one of the support elements and / or the retaining plate and / or wherein the recesses for the spacer are designed to enable a positive-locking connection, in particular a positive-locking rotary connection, or an elastically preloaded bearing, wherein the connection or bearing may in particular be designed as a clamping joint, clamping hinge, cylindrical joint, snap joint, ball joint, cardan or universal joint, single-axis joint, snap connection, detentable plug connection, spring mechanism or a combination thereof.

9. Device according to one of the preceding claims, wherein the distance created by the spacer reduces the force exerted on a chewing surface and / or dental appliance and / or prevents direct contact between opposing chewing surfaces and / or between a chewing surface and a dental appliance and / or the lower support element.

10. Device according to one of the preceding claims, wherein the spacer comprises a metal that prevents plastic deformation in at least one direction between the upper support element (102) and the lower support element (104) when force is exerted or movement is carried out by the mandible, in particular when the mandible is closed or when biting force is applied.

11. Device according to one of the preceding claims, wherein the spacer is secured against unintentional falling out and / or non-symmetrical positioning by an additional retaining element.

12. Device according to one of the preceding claims, characterized in that the spacer and / or the entire device is left-right symmetrical.

13. Device according to one of the preceding claims, wherein the spacer has a change of direction between a lower end connected to the lower support element, in particular the retaining plate, and an upper end connected to the upper support element, and wherein the spacer has a straight, curved, kinked and / or round profile in sections, in particular in the form of an angular, round or semicircular line figure, for example in S-shape, U-shape or Y-shape.

14. Device according to one of claims 12 or 13, wherein the spacer is oriented such that the upper support element rests against the palate behind the teeth, in particular between 1 millimeter and 20 millimeters, measured from a chewing surface of the upper front teeth, and / or wherein the spacer extends upwards and preferably forwards at its upper end in the oral cavity.

15. Device according to one of the preceding claims, wherein the spacer has at least two legs, each of which begins on and / or in the lower support element and / or on and / or in the retaining plate and converges from there.

16. Device according to claim 15, wherein the spacer extends in the oral cavity above the tongue and has a U-shape, for example, in plan view U-shaped with the open legs pointing towards the mouth opening and / or viewed from the mouth opening in an inverted U-shape pointing upwards or in a U-shape pointing downwards, and / or in a Y-shape, for example with downward-pointing fork arms.

17. Device according to claim 15 or 16, characterized in that the spacer has a section extending in the direction of the upper support element, wherein this section is formed from the base connecting the two legs in a U-shape and / or Y-shape.

18. Device according to one of claims 13 to 17, wherein at least the lower section of the spacer extends substantially parallel to the lower support element away from the teeth into the interior of the oral cavity.

19. Device according to one of the preceding claims, wherein at least one of the support elements, in particular both support elements, and / or the retaining plate is made in one piece with the spacer.

20. Device according to one of the preceding claims, wherein the spacer is temporarily or permanently connected to the retaining plate and / or one of the support elements, wherein the connection may in particular be made by screwing, plug connection or other mechanical coupling.

21. Device according to one of the preceding claims, characterized in that the spacer and one of the support elements together form a rotationally symmetric joint structure, wherein either the spacer is configured as a cy- The lindric element and the support element are designed as an associated receptacle, or the support element is designed as a cylindrical element and the spacer as an associated receptacle.

22. Device according to claim 21, characterized in that the retaining plate and / or the spacer are temporarily connected to one of the support elements in such a way that separation of the components is only possible outside the oral cavity, preferably only using a tool.

23. Device according to one of the preceding claims, characterized in that the spacer (106) is substantially perpendicular to a support element.

24. Device according to one of the preceding claims, wherein the spacer is designed in multiple parts, comprising an anchoring body with a fastening structure for anchoring in and / or on one of the support elements and / or in and / or on the retaining plate and / or in the spacer itself, an attachment part with a connecting profile that can be attached to the anchoring body, for example a support surface and / or the retaining plate and / or in the spacer, in a form-fit or force-fit manner;and a connecting element for fixing the attachment part in the connection profile of the support surface and / or the retaining plate and / or the spacer, such that by actuating the connecting element the attachment part is secured relative to the support surface in such a way that a force-transmitting connection is created, wherein the mechanism of action consists in the fact that by tightening the connecting element the attachment part is fixed to the anchoring body and held on the attachment part by positive or non-positive locking.

25. Device according to one of the preceding claims, wherein the device has a joint, for example a clamping joint, a clamping hinge, a cylindrical joint, a snap joint, an elastically preloaded bearing, a ball joint, a single-axis joint or a hinge, and the spacer is mounted on the upper or lower support element by means of the joint in such a way that at least one degree of freedom of movement exists between the support element and the spacer, preferably in the forward-backward direction.

26. Device according to claim 25, wherein the mounted arrangement of the spacer enables movement of the lower jaw relative to the upper jaw in a left-right direction and / or in a forward-backward direction.

27. Device according to claim 25 or 26, wherein the restriction of movement is effected by a lateral narrowing and / or an extension of the socket downwards and / or by a more angular design of the socket and / or the spacer is shaped such that the socket rests directly on the side of the spacer on which the movement is to be restricted, and / or by an individual adaptation of the upper support element.

28. Device according to one of the preceding claims, wherein at least one support element and / or the spacer are formed or connected to each other by a hinge or a joint, in particular a ball joint or single-axis joint, in particular by a connection which is or can be produced under the influence of force or heating.

29. Device according to claim 28, wherein the device comprises a joint socket formed in the support element, wherein the joint socket has an inlet opening. having a diameter that is smaller than the diameter of a spacer end piece formed in the spacer, in particular a ball, so that the spacer end piece can be snapped into the joint socket by force and / or heating of the support element, and wherein the snap-in connection is designed in such a way that it enables a joint function and at the same time prevents unintentional loosening.

30. Device according to claim 28 or 29, wherein the joint socket has an elastically designed locking lip which, when the spacer end piece, for example the ball, is inserted, temporarily deforms outwards and, after the spacer end piece, for example the ball, springs back behind it and locks.

31. Device according to any one of the preceding claims 28 to 30, wherein the socket joint has a conically recessed inner contour which provides a multi-point support for the spacer end piece, for example the ball, to increase the holding force.

32. Device according to any one of the preceding claims 28 to 31, wherein the joint socket has at least one gap, for example in the form of a semicircular ring segment, which is bounded by two spaced-apart circular arcs of the same curvature to increase the elasticity of the joint socket and to facilitate insertion and removal of the joint.

33. Device according to any one of the preceding claims 28 to 32, wherein the spacer end piece, preferably the ball of the ball joint, has a flattened zone which engages in a corresponding guide of the joint socket, so that the spacer end piece, preferably the ball, is rotatable only about one axis within the joint socket, or the joint is designed as a single-axis joint or cardan or universal joint.

34. Device according to any one of the preceding claims 28 to 33, wherein the joint socket additionally has a positive locking rotational restraint which prevents the spacer end piece, preferably the ball, from twisting in at least one spatial direction.

35. Device according to at least one of the preceding claims, characterized in that a support element has one or more fastening elements for attaching the device to one or more teeth of the lower jaw and / or upper jaw and / or in the oral cavity, and / or which is / are designed for temporary or permanent attachment to one or more dental appliances, in particular braces or dental splints, placed in the oral cavity.

36. Device according to one of the preceding claims, wherein a material of the device comprises PA2200 (polyamide), acrylate, PETG (polyethylene terephthalate glycol), PMMA (polymethyl methacrylate), PVC (polyvinyl chloride), PET (polyethylene terephthalate), PP (polypropylene), PEEK (polyetheretherketone), PEI (polyetherimide), silicone, stainless steel, titanium, cobalt-chromium alloys, tantalum, thermoplastic, photopolymer resin, in particular KeySplint Soft, and / or zirconium, wherein the material of at least a part of the device, preferably the entire device, is biocompatible.

37. Device according to one of the preceding claims, wherein the spacer (106) is made of an inelastic material, in particular titanium, or an elastic, It is made of or consists of a resilient and dimensionally stable material, in particular such that it deforms only slightly elastically under the forces occurring in use and returns to its original shape after being relieved.

38. Device according to any of the preceding claims, wherein the spacer has a Shore hardness of at least 50, determined according to Scale D, a modulus of elasticity of at least 700 MPa, determined according to ASTM D790, and / or a flexural strength of at least 2.0 MPa, determined according to ISO20795-2, wherein a material of the spacer is in particular based on methacrylates, for example KeySplint Soft Clear.

39. Device according to one of the preceding claims, wherein at least a part of the device is configured to cure under the influence of visible light, radiation, after heating or otherwise in order to assume a permanent shape and / or wherein the device comprises thermoplastics, photopolymer resin, a two-component paste or a combination thereof.

40. Device according to one of the preceding claims, characterized in that at least one support element consists partly of a flexible material, for example a silicone cushion, or at least at least one of the support elements is at least partly covered with a flexible material, for example silicone, or is at least partially enclosed by an elastically deformable shell, for example made of silicone, wherein the shell is preferably attached over the support element in a form-fitting and / or force-fit manner.

41. Device according to one of the preceding claims, wherein the lower support element and / or the upper support element are formed in multiple parts.

42. Device according to one of the preceding claims, characterized in that some or all points touching the body, in particular the soft tissues, as well as the overall shape of the device are smooth and rounded, in particular the surfaces adjacent to the tongue and / or palate (for example without threads), and / or are adapted to the palate and tooth shape of the user in order to avoid injuries or pressure points.

43. Device according to one of the preceding claims, wherein the device does not change the position of the tongue in the rest position or only changes it slightly, by a maximum of 6 mm, for example by providing a cavity for the tongue.

44. Device according to one of the preceding claims, wherein the device has a mechanism for adjusting the width, for example a thread, a sliding mechanism, a spreading mechanism, an adaptable material, or an adjustment device such as an interchangeable part in different widths in a segmented design, such that the width of the device is adaptable.

45. Device according to one of the preceding claims, wherein the individual parts, in particular the spacer and / or the retaining plate and / or the upper support element, are designed to be interchangeable in order to adapt the device to different mouth shapes, in particular to different palatal heights or widths of the dental arch, wherein the interchangeability ensures a defined distance and at the same time a closed mouth for all users.

46. ​​Device according to one of the preceding claims, wherein the device, in particular the spacer and / or the upper support element, has a height adjustment mechanism, whereby the height of the device can be individually adjusted.

47. Device according to claim 46, wherein the height adjustment mechanism comprises a pair of lever arms pivotably connected at their ends and forming a variable support opening, wherein the height adjustment is effected via a threaded spindle arranged on the lever arms, which is guided through threaded bores in the lever arms, and a crank or rotary device is attached to the threaded spindle, which enables the lever arms to be moved apart and together by means of a scissor-like movement by means of rotation, whereby the upper end of the spacer can be raised or lowered relative to the lower end, and the lever arms are each coupled at their center by a hinge joint to ensure a defined and stable movement.

48. Device according to claim 46, wherein the device comprises an expansion apparatus, wherein by turning a central screw a lower and an upper height adjustment element are moved away from each other to enable a height adjustment of the device, wherein the screw is preferably designed as a spindle with opposing thread sections.

49. Device according to one of the preceding claims, wherein at least one spacer disc is arranged between the spacer and a support element, the spacer disc being configured to selectively increase the vertical distance between the spacer and the support element, wherein the spacer, the spacer discs and the support element are connected to each other by means of a common connecting element, such as a screw, in a force-fit and / or form-fit and / or detachable manner.

50. Device according to one of the preceding claims, wherein, based on a 3D scan and / or an impression taken by the user and / or medical personnel, the device is individually adapted to the user's oral cavity and / or the variant with the most suitable properties is selected from existing size variants, wherein at least a part of the device and / or the adaptation device is manufactured by means of 3D printing, deep drawing, coating, milling, grinding, polishing or other manufacturing processes suitable for individualization.

51. Device according to one of the preceding claims, wherein an attachable and / or removable adjustment device (2300), preferably on the upper or lower support element or the spacer, is provided to individually adapt the outer shape of the device to the user's oral cavity, preferably the size of the device, or to increase or decrease wearing comfort to generate biofeedback, for example by the surface shape of the adjustment device in the form of a cylinder, a flattened sphere, a hemisphere, a spindle or a cone.

52. Device according to claim 51, wherein the adapting device (2300) has a functional part and one or more connecting parts, wherein the connecting part is designed to connect the adapting device (2300) to the upper and / or lower support element and / or spacer.

53. Device according to one of the preceding claims, wherein the device has a biofeedback mechanism, wherein the biofeedback mechanism provides feedback to the user via one or more human senses in the event of jaw movement and / or force action resulting from mandibular movement.

54. Device according to claim 53, wherein the biofeedback mechanism comprises an elastic component, wherein the elastic component is designed such that, upon reaching a predetermined threshold of jaw movement and / or force from jaw movement, it exhibits a distinct switching behavior and transitions from one state to another.

55. Device according to claim 54, wherein the elastic component has at least one snap disc which, upon reaching a predetermined threshold of jaw movement and / or force from jaw movement, exhibits a distinct switching behavior and transitions from one state to another and returns to its original state when a predetermined threshold is undershot.

56. Device according to claim 55, wherein the snap disc (3564) is designed to generate acoustic and / or tactile feedback when it is deformed by a force generated by a mandibular movement and / or a relative movement between the maxilla and mandible, or when it returns to its original state.

57. Device according to claim 55 or 56, wherein the snap disc is arranged in the upper and / or lower support element, in particular in the upper support element.

58. Device according to one of claims 55 to 57, wherein the spacer has a contact surface at its end that can be brought into contact with the snap disc, for example a pin, a ball joint, a universal joint or a uniaxial joint, by which the snap disc (3564) is deformed and released by a pressure exerted by the contact surface (3672), wherein the contact surface preferably has a maximum area of ​​2000 mm² 2 , especially preferred less than 1 mm 2 is and is preferably flat, rounded and / or conical in shape.

59. Device according to claim 58, wherein the contact surface of the spacer is arranged within a ring which prevents it from sliding out, and / or has a clearance of 0.2 to 1.5 mm, preferably 1 mm, up to the snap disc to allow the snap disc to return to its original state.

60. Device according to one of claims 54 to 59, wherein the elastic component is housed in a protective casing.

61. Device according to one of the preceding claims, wherein the upper and / or lower support element and / or the spacer is designed as a protective housing enclosing a component arranged therein.

62. Device according to one of claims 55 to 61, wherein the snap disc (3564) is designed in multiple versions to increase the intensity of the generated biofeedback, wherein the double version can be designed to respond to relative movements between the upper and lower jaw from both directions.

63. Device according to one of claims 55 to 62, wherein the support element containing the snap disc has openings, wherein the openings are designed in such a way that this support element can be cleaned with a toothbrush, wherein the toothbrush can preferably be inserted through the openings from several sides so that all relevant inner surfaces of the support element are accessible.

64. Device according to claim 53, wherein the biofeedback mechanism comprises a piezoelectric element (4322) configured as a sensor for a bruxism event and / or as a source for biofeedback and / or as an energy source, wherein the piezoelectric element (4322) is preferably configured to generate acoustic, tactile, visual or electrical feedback when pressed by a mandibular movement or force generated from the relative movement of the maxilla and / or mandible, wherein the piezoelectric element (4322) in particular drives a vibration element and / or a buzzing device.

65. Device according to claim 64, wherein the piezo element (4322) is configured to transmit electrical biofeedback to the user via a conductive surface of the device.

66. Device according to one of the preceding claims, characterized in that the device has an energy storage device, preferably a battery (4428).

67. Device according to one of the preceding claims, wherein the device comprises at least one, preferably several and in particular all of the following units: a charging socket, for example for a USB port, or a charging station (4438), a microcontroller (4430), a data storage device, a waterproof, non-conductive housing, a sensor that monitors force, muscle activity, vibration and / or movement and a feedback device for generating biofeedback, for example a motor that produces vibration and noise.

68. Device according to claim 67, characterized in that the device can be connected wirelessly or by means of a cable connection to a server and / or an end device, for example a smartphone, in order to enable, for example by means of a software application, permanent data storage and monitoring of the user.

69. Method for manufacturing a device for the treatment and / or prevention and / or testing of bruxism and / or craniomandibular dysfunction (CMD), comprising the following steps: Obtaining and / or creating a digital or physical model (for example, by means of an alginate impression of the dentition, which is then cast with super-hard plaster) of the user's oral cavity, in particular including the palate and teeth; and Using the digital or physical model of the user's oral cavity to create the device according to the invention, preferably by means of a computer system and optionally with the support of an AI-assisted (artificial intelligence) analysis for (semi-)automatic evaluation, in order to propose or determine an anatomically and functionally optimized configuration of the device, wherein the use comprises: o virtually shaping an upper support element, the outer surface of which is designed to correspond to at least a part of the palate, o virtually shaping the lower support element, wherein the lower support element has an outer surface that is shaped to correspond to at least a part of the mandible, Selection of the correct height and width of the preferably digital, prefabricated parts of the device, in particular the spacer; virtual positioning of the spacer in relation to the oral cavity and the support elements to ensure the distance between the occlusal surfaces; virtual positioning of the attachment element(s) in the oral cavity; and preferably virtual positioning of the biofeedback device.

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