RU2797642C2 - Dental device for the treatment of night apnea, snoring and remodeling of the language and mouth - Google Patents

Abstract

FIELD: dental devices.

SUBSTANCE: inventions relate to the field of dental devices, in particular, to dental devices and methods for fixing and correcting the position of the tongue. In accordance with the first aspect, a dental device for restricting the movement of the back region of the patient's tongue allowing the front region and the lateral edges of the tongue to perform the movements required for speech and swallowing, containing an attachment mechanism for attaching the dental device to the teeth in the patient's oral cavity, including an open circular tape, connecting element is presented. In accordance with other aspects, a dental device comprising an attachment mechanism for fixing the dental device to teeth in a patient's mouth, and assemblies for use by the patient in an individual tongue restriction plan, the assemblies including a limiting mechanism, an adjustment mechanism, and a locking mechanism are presented.

EFFECT: inventions make it possible to eliminate respiratory disorders during sleep associated with tongue dysfunction, while providing the possibility of movements of the back region, tip and side ribs of the tongue required for speech and swallowing.

37 cl, 18 dwg

Description

Technical field

The invention relates to the field of dental devices, in particular dental devices for fixing and correcting the position of the tongue.

State of the art

Dental devices, including orthodontic devices, have been used for many years to correct various defects and conditions associated with the teeth and jaws. However, many of these dental devices do not take into account the role of the tongue in the development and persistence of certain dental, mandibular, and palatal disorders.

The tongue includes the pharyngeal and oral parts. The pharyngeal part starts from the hyoid bone and connects to the skull and pharynx, while the oral part connects to the anterior part of the lower jaw and is the externally visible part of the tongue, in particular, the tip of the tongue, the anterior central region of the tongue and the back of the tongue.

For some reason, including birth defects and/or habits formed during childhood (for example, when an infant transitions from sucking to chewing and learning to speak), the tongue becomes misaligned in the mouth. As a result, the tongue is in an abnormal position, and this condition is known as "tongue dysfunction". Tongue dysfunction can sometimes lead to the development of oral and mandibular disorders, such as malocclusion or vestibular-labial displacement of some teeth. Dysfunction of the tongue can also contribute to the development of respiratory disorders during sleep, such as snoring or sleep apnea. In particular, a tongue in an improper resting position does not provide palatal expansion. This in turn causes the palate to become shallow, which reduces the volume of the nasal fossa and can lead to constriction of the pharynx and, more generally, the upper airways. This can lead to impaired nasal breathing, resulting in forced breathing through the mouth (oral breathing). In other cases, the tongue, which is in a posterior upper position relative to the posterior palate, reduces the size of the pharynx or even leads to its obstruction. This narrowing of the airways can lead to severe snoring and, in some cases, to the development of obstructive sleep apnea, i.e., a condition in which a sleeping person stops breathing for one or more time periods. Obstructive sleep apnea can have moderate to severe consequences, including fatigue, drowsiness, chronic headaches, and in the most severe cases, cardiovascular and metabolic disorders.

Current strategies for dealing with language dysfunction include specific exercises. In particular, the treatment of disorders associated with this condition primarily includes the use of various medical procedures, including orthodontic. However, both exercises and orthodontic procedures are time consuming, costly, do not always lead to successful results and often lead to relapses. Among the reasons for relapse is the inability to completely change the position of the tongue. Without changing the position of the tongue, including in the postoperative period, to correct improper movements, the patient reflexively continues to move the tongue in the same way as before, and its position again becomes incorrect, as before treatment.

In this regard, there is a need for devices and methods for changing and correcting the position of the tongue to eliminate or alleviate the symptoms associated with tongue dysfunction. In addition, there is a need for tongue training devices and methods for correcting tongue dysfunction and correcting buccal structural defects associated with dysfunction without orthodontic therapy.

The Applicant has been successful in alleviating the symptoms of the above disorders by developing the tongue fixation devices described in US 2011/0284011 A1, publ. 11/24/2011, and the application US 2011.0262881 A1, publ. November 27, 2011

The present devices are improvements to the devices described in the above patent publications in terms of design, appearance and functionality. For example, previous devices were early versions and could only be removed from the oral cavity by a specialist; they were attached to the molar (or other back) teeth with a band around the teeth or other bulky device, including (in some embodiments of the invention) a device that prevents the teeth from fully closing; and/or in the case of adjustable ones, adjustment, in particular multiple adjustments, could lead to device failure and subsequent replacement. The design of the device often included shells for fixing the component to the attachment mechanism and had a similar appearance to the prototype, which was inconvenient for professionals using the device during business meetings and in general in a business environment. In addition, the adjustment was extremely difficult to perform during treatment.

Disclosure of the invention.

The invention presented herein are devices and methods for restricting the movement of the tongue.

According to a first aspect, a dental device is provided for restricting the movement of a part of the tongue.

In accordance with one aspect, a dental device is provided for restricting movement of the posterior region of a human tongue while allowing movements of the anterior region and lateral ribs of the tongue required for speech and swallowing.

According to another aspect, a dental device is provided for restricting movement of the central region of a human tongue while allowing movements of the posterior region, tip, and lateral ribs of the tongue required for speech and swallowing.

The dental device includes an attachment mechanism for fixing the dental device to teeth in the human oral cavity.

The fastening mechanism includes a mainly circular tape having a first surface located on the buccal side of the human dental arch (when using the device), and a pair of left and right second surfaces, each of which is located opposite the first surface (when using) along at least one back , respectively, of the left or right teeth, on the lingual side of the above at least one tooth (or at least two and preferably no more than three teeth).

The fastening mechanism also includes a connecting element connecting the first surface and the second surface.

The attachment mechanism is adapted for fixation on the human dental arch with the possibility of subsequent removal from the dental arch.

The dental device also includes a restraining mechanism attached, preferably releasably, to the attachment mechanism and including a component stretched between a pair of second surfaces.

In accordance with an aspect of the present application, the component is reverse-directional and configured to be positioned approximately in or at an angle to the wearer's occlusal plane to limit movement of the posterior region of the tongue and thereby narrow the tongue's range of motion to a more limited three-dimensional space, than in the absence of the device, while simultaneously allowing at least the anterior region and the lateral ribs of the tongue to carry out the movements necessary for speech and swallowing. It should be noted that in this document, for convenience, we are talking about the occlusal plane, however, the occlusal plane is part of the geometry of the patient, and not part of the geometry of the device.

Alternatively, we can talk about a plane defined by the end parts of the components of the device (see, for example, elements 335 of component 305 in Fig. 6B-C, 7A, 8B-C or elements 535 of component 505 in Fig. 10B-C, 11B-C and 12A). This alternate reference is often used later in the text.

In accordance with another aspect, the component is centrally positioned relative to the second surfaces and the front of the tape to be located near the central part of the tongue, and is oriented in a forward direction. In the latter aspect, the forward-facing component is configured to be positioned (in use) approximately in or at an angle to the patient's occlusal plane when the device is being worn, in each case in order to limit movement of the central region of the tongue and thereby narrow the tongue's range of motion. to a limited three-dimensional space, while allowing the movements of the posterior region, tip and lateral ribs of the tongue necessary for speech and swallowing.

In accordance with some embodiments in any of the above aspects, the restraining mechanism or the attachment mechanism (or both) includes an adjustment mechanism that in the first aspect is adapted to change the angle of the component relative to the occlusal plane of the patient (or relative to the basal plane of the end portions of the component) while wearing the device , thereby controlling the degree of restriction of tongue movements, and in the second aspect, it is adapted for adjustment (and subsequent fixation) of the position of the component back or forward along the longitudinal axis of the device.

According to another aspect, the restraint mechanism component is stretched between the left and right second surfaces at the rear portion of the belt immediately adjacent the pair of second surfaces.

In accordance with another aspect, the limiting mechanism has one end part connected to the left second surface, and the second end part is connected to the right second surface.

In accordance with another aspect, the limiting mechanism (preferably releasable) is attached to the attachment mechanism by a locking mechanism.

According to another aspect, the generally circular band includes a resinous material in contact with the dental arch when the device is worn.

Preferably, the second surfaces of the band lingually span a length of no more than three of the patient's back teeth, so that the circular band is substantially but not completely circular, allowing the tongue to reach the lingual side of most of the wearer's teeth.

Yet another preferred feature is that the attachment mechanism primarily encloses the buccal surface of the user's upper arch crowns, however leaving the chewing (biting) surfaces of the teeth free of fasteners.

In some embodiments, the first, buccal surface of the circular band covers approximately 70-80% of the buccal surface of the crowns of the teeth, i.e., below the gum line.

In some embodiments, the resinous material of the attachment mechanism may cover substantially the entire surface of the upper arch crowns.

In some embodiments, the first surface of the attachment mechanism may cover the gum line to provide patient comfort. However, preferably, the buccal attachment mechanism should conform to the contour, be aligned with the gum line, and cover most of the buccal surface of the dental arch without covering the bite surfaces of the teeth.

According to yet another aspect, the generally circular band also includes an oblique palatal wing attached to the lingual side of the second surfaces.

In accordance with another aspect, the wing includes a resinous material and may contain a sensor device. The sensor device may be integrated into the wing.

According to yet another aspect, the sensor device is a temperature sensor (to track compliance, i.e. determine if the device is in the mouth), a sound sensor (to track snoring and/or breathlessness), a pH sensor (to track pH and mouth breathing) or a pressure sensor (to monitor if the tongue is applying excessive pressure).

According to another aspect, the sensor device is placed in the resin wing in such a way that it does not touch the tissues (gums, teeth or palate) of the patient when the device is worn, and in this regard, the wing itself preferably has a similar configuration to prevent contact with the tissues of the user. to avoid discomfort.

According to another aspect, the restraint mechanism component is typically C-shaped, with the back of the component placed transversely with respect to the longitudinal axis of the device and is responsible for restricting the movements of the tongue, and the end portion of the restraint mechanism is responsible for attaching the restraint mechanism to the attachment mechanism of the corresponding , first or second, surface.

In accordance with another aspect, the limiting mechanism comprises a wire. In accordance with another aspect, the central section of the wire is covered with a polymeric material.

According to another aspect, the dental device includes an arcuate support member to enhance the rigidity or strength of the device. The arcuate element embraces the second surfaces and is arranged in an ascending transverse direction following the contour of the palate when the device is worn without touching the palate.

In another aspect, the restraint mechanism component is oriented backwards and angled relative to the attachment mechanism base, wherein the angle is from about 0° to about 30° relative to the occlusal plane when the device is being worn by the patient, or alternatively relative to the basal plane of the component. , specified by the ends of the component.

In another aspect, the restraint mechanism component is oriented forward and inclined at an angle ranging from about 0° to about 30° relative to the occlusal plane when the device is worn by the patient, or alternatively relative to the basal plane of the component defined by the end portions of the component.

According to another aspect, the restraint mechanism component comprises a wire, and the adjustment mechanism comprises a pair of oblique or vertical loops or stops, each within an end section of the restraint mechanism and on the side of a respective second surface of the attachment mechanism.

According to another aspect, the restraining mechanism component comprises a wire, and the adjustment mechanism comprises a pair of horizontal wire loops for possible lateral expansion of the component (eg, expansion in a direction transverse to the sagittal plane of the dental arch).

In accordance with another aspect, the loops are formed from the wire of the limiting mechanism.

According to another aspect, the component includes a center brace for flexibility and possible lateral expansion of the component.

In accordance with another aspect, the locking mechanism includes a tab or tab embedded in the resin material of one of the first and second surfaces of the locking mechanism for locking the locking mechanism to the locking mechanism.

In accordance with another aspect, the locking mechanism may include a sheath including a chute so that the end portion of the restraint mechanism is included in the sheath. The locking mechanism may also include a tension member for locking the end portion of the restraining mechanism in the chute.

According to yet another aspect, the tension member is selected from the group consisting of a combination of a nut and a bolt.

In accordance with another aspect, the tension element is a clip. According to yet another aspect, each of the end portions of the restraint mechanism includes a vertical loop of wire, and the locking mechanism includes a sheath and a rubber band for wrapping around the sheath and loop.

In accordance with another aspect, the locking element allows you to adjust the position of the component longitudinally in the forward or reverse direction. In some such embodiments, a limiting mechanism is slidably mounted on the adjustment mechanism to allow adjustment of the position of the component along the longitudinal axis of the device, whether the component is oriented forward or backward.

In accordance with another aspect, the component is oriented in the forward direction and the control mechanism does not contain loops.

In accordance with another aspect in which the component is oriented in the forward direction, the component comprises a wire with a central bracket for possible lateral expansion of the component.

This and other aspects, features and advantages are explained in the accompanying descriptions of some embodiments of the invention and accompanying drawings, and claims.

The following embodiments are examples of the present invention.

1. Dental device for limiting the movement of the back region of the patient's tongue, allowing movements of the anterior region and lateral ribs of the tongue, necessary for speech and swallowing; dental device includes:

an attachment mechanism for fixing the dental device to the teeth in the patient's mouth, while

the fastening mechanism includes mainly, but not completely, a circular tape containing:

the first surface located on the buccal side of the dental arch of the patient;

a pair of left and right second surfaces, each of the second surfaces opposite the first surface is adapted to be placed together with at least one back, respectively left or right, tooth on the lingual side of the above, at least one tooth, and the above second surfaces are adapted under the passage along the lingual side of a limited number of back teeth of the patient; And

a connecting element connecting the first surface and the second surface; and a releasably restrictive mechanism attached to the attachment mechanism and comprising a component stretched between a pair of second surfaces, the component being backward oriented and configured to be positioned approximately in or at an angle to the wearer's occlusal plane to restrict movement the posterior region of the tongue and thereby narrow the range of motion of the tongue to a more limited three-dimensional space than without the device, while allowing at least the anterior region and the lateral ribs of the tongue to carry out the movements necessary for speech and swallowing;

wherein:

the mechanism is adapted for fixation on the patient's dental arch with the possibility of subsequent removal of the device from the dental arch.

2. Dental device, including:

an attachment mechanism for fixing the dental device to the teeth in the patient's mouth,

wherein the fastening mechanism includes mainly, but not completely, a circular tape containing:

a first surface on the buccal side of the patient's dental arch;

a pair of left and right second surfaces, each of the second surfaces, opposite the first surface, is adapted for placement together with at least one back, respectively left or right, tooth on the lingual side of the above, at least one tooth, and the above second surface adapted to pass along the lingual side of a limited number of back teeth of the patient; And

a connecting element connecting the first surface and the second surface; and a releasably restrictive mechanism attached to the attachment mechanism and comprising a component stretched between the pair of second surfaces and centrally positioned with respect to the second surfaces and the front of the tape to be located at the central part of the tongue, and the component is oriented in a forward direction and configured to be located approximately in or at an angle to the occlusal plane of the wearer, in each case to limit movements of the central region of the tongue and thereby narrow the range of motion of the tongue to a limited three-dimensional space, while allowing for the movements of the posterior region, tip and lateral ribs of the tongue required for speech and swallowing;

while the attachment mechanism is adapted for fixation on the dental arch of the patient with the possibility of subsequent removal of the device from the dental arch.

3. The dental device of Embodiment 1 or 2, wherein the restraint or attachment mechanism includes an adjustment mechanism to adjust: (i) the angle of the component relative to the patient's occlusal plane when the device is worn, and thereby control the degree of tongue restriction; or (ii) the position of the component along the longitudinal axis of the device and thereby to control the area of the tongue where the constraint will be applied; or (iii) both the above angle and the above position.

4. The dental device of Embodiment 1 or 2 wherein the component is stretched between the right and left second surfaces at the back of the tape in close proximity to the pair of second surfaces.

5. The dental device of Embodiment 3, wherein the restraint mechanism has one end that is connected to the left second surface and a second end that is connected to the right second surface.

6. The dental device of Embodiment 1 or 2, wherein the substantially circular band includes a resinous material in contact with the dental arch when the device is worn.

7. The dental device of Embodiment 6, wherein the first surface of the attachment mechanism conforms to the contour and correlates with the gum line from the buccal surface of the patient's upper dental arch.

8. The dental device of Embodiment 7, wherein the first surface of the attachment mechanism encloses at least a large portion of the buccal surface of the dental arch from the gumline and downwards, but does not substantially enclose the bite surface of the teeth of said arch.

9. The dental device of Embodiment 1 or 2, wherein the above limited number of posterior teeth is one to three.

10. The dental device of Embodiment 1 or 2, wherein the restraint mechanism is attached to the attachment mechanism by a locking mechanism.

11. The dental device of Embodiment 1 or 2, wherein the substantially circular band also includes a wing attached to the lingual side of the second surface, the wing comprising a sensor device optionally embedded in the wing.

12. The dental device of Embodiment 11, wherein the sensor device is a temperature, pH, or sound sensor.

13. The dental device of Embodiment 11 further comprising at least one of the following:

the wing contains a resinous material; And

the sensor device is embedded in a resinous material and positioned so as not to touch the patient's palate or teeth when the device is being worn by the patient.

14. The dental device of Embodiment 9, wherein the component is generally C-shaped, wherein the back of the component is transverse to the longitudinal axis of the device and is responsible for limiting tongue movements, and wherein the restraint mechanism has first and second end portions. for attaching the limiting mechanism to the attachment mechanism of the corresponding second surface by means of a locking mechanism..

15. The dental device of embodiment 1, 2, or 14, wherein the component is angled to a plane defined by the two end portions of the limiting mechanism.

16. The dental device of embodiment 1, 2, or 10, wherein the restraining mechanism includes a wire, optionally including a core section coated with a polymeric material.

17. The dental device of Embodiment 1 or 2, further comprising an arcuate support member to enhance the rigidity or strength of the device, wherein the arcuate member encloses second surfaces and is positioned ascending following the contour of the palate and not touching the patient's teeth or palate while wearing the device.

18. The dental device of Embodiment 1 wherein the component is inclined at an angle relative to a plane defined by the end portions of the restraint mechanism, wherein the angle is from about +15° to about -15° when the device is worn by a patient.

19. The dental device of Embodiment 3, wherein the adjustment mechanism includes a pair of oblique or vertical loops or stops, each of the loops being within an end section of the restriction mechanism, the loops being formed by a wire and intended to adjust the angle of a component.

20. The dental device of Embodiment 3 wherein the restraint mechanism includes a wire and the adjustment mechanism includes a pair of horizontal loops of wire, the loops being formed by the wire and each of the loops being in close proximity to the end portion of the restraint mechanism for eventual lateral expansion of the component.

21. The dental device of Embodiment 1 or 2, wherein the component includes a wire with a central brace for flexibility and possible lateral expansion of the component.

22. The dental device of Embodiment 3, wherein the locking mechanism is incorporated into one of the second surfaces of the attachment mechanism to lock the locking mechanism to the attachment mechanism.

23. The dental device of embodiment 22, wherein the locking mechanism further comprises (i) a sheath including a chute, the sheath slidably accommodating an end portion of the restraint mechanism, and (ii) a tension member for locking the end portion of the restraint mechanism into the chute.

24. The dental device of Embodiment 23, wherein the locking member includes a combination of a nut and a screw or a combination of a nut and a bolt, wherein each end portion of the restraint mechanism is slidably mounted and locked by the locking mechanism.

25. The dental device of Embodiment 23 wherein the restraint mechanism includes a pair of vertical or oblique wire loops and the locking mechanism includes a rubber band to wrap around the sheath and loop, thereby securing the end portion of the restraint mechanism to the attachment mechanism.

26. The dental device of embodiment 23, wherein the locking mechanism allows longitudinal adjustment of the position of the component forward or backward.

27. The dental device of Embodiment 1 or 2, wherein the limiting mechanism is slidably mounted in the adjustment mechanism by the locking mechanism to allow adjustment of the position of the component along the longitudinal axis of the device.

28. The dental device of embodiment 16 wherein the wire includes a center section coated with a polymeric material.

29. The dental device of Embodiment 1 or 2, wherein a slidable limiting mechanism is mounted in the adjustment mechanism to allow adjustment of the position of the component along the longitudinal axis of the device.

30. The dental device of Embodiment 2, wherein the restraint mechanism component is inclined at an angle relative to the patient's occlusal plane when the device is worn or a plane defined by the restraint mechanism ends, wherein the angle is from about 0° to about 30° when the device is worn by the patient.

31. The dental device of Embodiment 1 or 2, wherein the component also includes a wire with a center brace for flexibility and possible lateral expansion of the component.

32. The dental device of Embodiment 1 or 2, wherein the adjustment mechanism does not include hinges.

33. The dental device of embodiment 10, wherein the locking mechanism includes a tab or flap attached to or embedded in a corresponding second surface of the locking mechanism to lock the locking mechanism into the locking mechanism.

34. The dental device of embodiment 10, wherein the locking member provides fore and aft longitudinal adjustment of the component.

35. Assembly for restricting movement of the tongue when used in a dental device to restrict movement of the back region of the patient's tongue, and the assembly contains a limiting mechanism, an adjustment mechanism and a locking mechanism, while the limiting mechanism contains a component configured to bridge the gap between a pair of second surfaces a device attachment mechanism positioned along the lingual side of a limited number of a patient's back teeth, the component being oriented backwards relative to the patient's oral cavity and configured to be located approximately in or at an angle to the patient's occlusal plane to limit movement of the back of the tongue and thereby thereby narrowing the range of motion of the tongue to a more limited three-dimensional space than without the device, while allowing movements of at least the anterior region and lateral ribs of the tongue necessary for speech and swallowing;

the limiting mechanism has a pair of end portions, each slidably attached to the adjustment mechanism by means of a locking mechanism, which allows adjustment of the position of the component in the longitudinal direction, and each end portion is configured at an angle to the component and the two end portions defining the plane;

the locking mechanism is adapted for attachment to the attachment mechanism and includes a tension mechanism to secure the end portions of the limiting mechanism in the desired position.

36. An assembly for restricting the movement of the tongue when used in a dental device for restricting the movement of the back region of the patient's tongue, and the assembly includes a limiting mechanism, an adjustment mechanism and a locking mechanism, while:

the restraint mechanism includes a component configured to span a gap between a pair of second surfaces of a device attachment mechanism located along the lingual side of a limited number of patient back teeth, the component being oriented in a forward direction relative to the patient's oral cavity and configured to be located approximately in the occlusal plane of the patient, or at an angle to it, to limit movement of the posterior region of the tongue and thereby narrow the range of motion of the tongue to a three-dimensional space more limited than without the device, while allowing movements of at least the anterior region and lateral ribs of the tongue necessary for speech and swallowing;

the limiting mechanism has a pair of end portions, each slidably attached to the adjustment mechanism by means of a locking mechanism, which allows adjustment of the position of the component in the longitudinal direction, and each end portion is configured at an angle to the component and the two end portions defining the plane;

the locking mechanism is adapted to be locked in the locking mechanism and includes a tension mechanism to secure the end portions of the limiting mechanism in a desired position.

Brief description of graphic materials.

Fig. 1A-B represent various aspects of the patient's dental arch and illustrate the nomenclature used in this document;

Fig. 2A-C are bottom views (2A), lingual side views (2B), and buccal side views (2C) of a dental device attachment mechanism to an upper dental arch, in accordance with one or more embodiments;

Fig. 3A-C are bottom views (3A), lingual side views (3B), and buccal side views (3C) of an embodiment of an attachment mechanism further including (if necessary) an arcuate support member, in accordance with one or more embodiments;

Fig. 4 represents an exemplary sensory device for attachment to a dental device, in accordance with one or more embodiments;

Fig. 5A-B are bottom views (5A) and lingual side views (5B) of an embodiment of an attachment mechanism having one or, for balance, two wings and a sensor device incorporated into one wing (or optionally different devices incorporated into one or both wings) according to one or more embodiments;

Fig. 6A-C represent exemplary straight forward center brace restraint mechanisms in accordance with one or more embodiments. Fig. 6A represents exemplary lengths of a straight short limiter (FwS) and a straight forward long limiter (FwL) in accordance with one or more embodiments. Fig. 6B is a front view of an exemplary straight forward limiting mechanism, and FIG. 6C is a rear view of an exemplary straight forward restraint mechanism in accordance with one or more embodiments;

Fig. 7A-C depict an exemplary forward directional restraint mechanism and its attachment to an attachment mechanism having wings by means of a locking mechanism, in accordance with one or more embodiments.

Fig. 7A is a bottom view in which the limit mechanism is in the forward position,

Fig. 7B is a bottom view in which the limit mechanism is in the rear position and

Fig. 7C is a lingual side view in which the limiting mechanism is in the forward position;

Fig. 8A-C represent exemplary forward directional restraints and horizontal loops, in accordance with one or more embodiments.

Fig. 8A represents exemplary lengths of a straight short limiter (FwS) and a straight forward long limiter (FwL) in accordance with one or more embodiments.

Fig. 8B is a front perspective view of an exemplary straight forward limiter with horizontal hinges, and

Fig. 8C is a rear view of an exemplary straight forward restraint mechanism in accordance with one or more embodiments;

Fig. 9A-C present aspects of exemplary attachment mechanisms (including tensioners) and adjustment mechanisms (for reciprocating position adjustment of a limiting mechanism) in accordance with one or more embodiments;

Fig. 10A-C represent exemplary reverse (rear) direction limiting mechanisms in accordance with one or more embodiments.

Fig. 10A represents exemplary lengths of a reverse short limiter (BwS) and a reverse long limiter (BwL) in accordance with one or more embodiments.

Fig. 10B is a front view of an exemplary backward limiting mechanism, and

Fig. 10C is a plan view of an exemplary reverse restraint mechanism in accordance with one or more embodiments;

Fig. 11A-C represent exemplary reverse direction limiters and horizontal loops, in accordance with one or more embodiments.

Fig. 11A represents exemplary lengths of a Reverse Short Restraint (BwS) and component thereof and a Reverse Long Restraint (BwL) and component thereof, in accordance with one or more embodiments. Fig. 11B is a front view of an exemplary horizontal hinge reverse restraint mechanism, and

Fig. 11C is a plan view of an exemplary reverse restraint mechanism in accordance with one or more embodiments;

Fig. 12A-D show an exemplary reverse direction restraint mechanism and its attachment to a winged attachment mechanism by a locking mechanism, in accordance with one or more embodiments.

Fig. 12A is a bottom view in which the limiting mechanism is short and in the rear position,

Fig. 12B is a bottom view in which the limit mechanism is long and in the rear position, and

Fig. 12C is a lingual view in which the limit mechanism is long and in the rear position;

Fig. 12D illustrates the reverse component 505 and 505' with the center brace.

Fig. 13A-D represent the positioning of a component of exemplary restraint mechanisms to achieve minimal (low) pressure on the tongue, in accordance with one or more embodiments.

Fig. 13A represents the position of the minimum pressure on the dental arch for a long, direct limiting mechanism (FwL),

Fig. 13B represents the minimum pressure position for the short, direct limiter (FwS),

Fig. 13C represents the minimum pressure position for the long, backward restricting mechanism (BwS), and

Fig. 13D represents the minimum pressure position for the long reverse limiter (BwL);

Fig. 14A-D represent the positioning of a component of an exemplary restraint mechanism to achieve maximum (strong) pressure on the tongue, in accordance with one or more embodiments.

Fig. 14A represents the position of the maximum pressure on the dental arch for a long, direct limiting mechanism (FwL), FIG. 14B represents the maximum pressure position for the short, direct limiter (FwS),

Fig. 14C represents the maximum pressure position for the short, reverse restrictor (BwS), and

Fig. 14D represents the position of maximum pressure for the long, backward limiting mechanism (BwL);

Fig. 15A-F represent an exemplary treatment plan for treating a language condition associated with obstructive sleep apnea syndrome (OSAS), in accordance with one or more embodiments.

Fig. 15A is an enlarged diagram of the shape of the tongue in an abnormal position associated with obstructive sleep apnea, and

Fig. 15B is a layout diagram of the pinnacle of the constraint mechanism component for each of four exemplary steps (indicated by a series of dots) for treating the tongue condition shown in FIG. 15A.

Fig. 15C-F represent the type of component and the positioning of the top of the limiter component relative to the tongue for the respective four stages of treatment;

Fig. 16A-G represent an exemplary treatment plan for treating a tongue condition associated with malocclusion and/or snoring, in accordance with one or more embodiments.

Fig. 16A is an enlarged diagram of the shape of the tongue in an abnormal position associated with malocclusion and/or snoring, and

Fig. 16B is a layout diagram of the pinnacle of the constraint mechanism component for each of five exemplary steps (indicated by a series of dots) for treating the tongue condition shown in FIG. 16A.

Fig. 16C-G represent the component type and positioning of the top of the constraint mechanism component relative to the tongue for the respective five treatment steps;

Fig. 17A-D represent an exemplary treatment plan for treating a tongue condition associated with malocclusion, in accordance with one or more embodiments.

Fig. 17A is an enlarged diagram of the shape of the tongue in an abnormal position associated with malocclusion, and

Fig. 17B is a layout diagram of the pinnacle of the constraint mechanism component for each of two exemplary steps (indicated by a series of dots) for treating the tongue condition shown in FIG. 17A.

Fig. 17C-D represent the component type and positioning of the top of the constraint mechanism component relative to the tongue for the respective two treatment steps;

Fig. 18A-D represent an exemplary treatment plan for treating a tongue condition associated with persistent swallowing disorder, in accordance with one or more embodiments.

Fig. 18A is an enlarged diagram of the shape of the tongue in an abnormal position associated with persistent swallowing disorder, and

Fig. 18B is a layout diagram of the pinnacle of the constraint mechanism component for each of two exemplary steps (indicated by a series of dots) for treating the tongue condition shown in FIG. 18A.

Fig. 18C-D represent the component type and positioning of the top of the constraint mechanism component relative to the tongue for the respective two treatment steps.

Detailed description of some embodiments.

As a brief overview and introduction, this document describes devices and methods for restricting tongue movement. It should be appreciated that despite the strategies currently being used by others to reverse tongue dysfunction and the effects of language-related medical conditions, treatments are often ineffective, overly invasive, or both.

In order to combat the effects of tongue dysfunction, as well as macroglossia resulting in such consequences, the devices and methods described herein limit the movement of the patient's tongue and help to correct or correct the position of the patient's tongue in such a way as to eliminate the violation of the morphology of the language and the consequences of dysfunction. language. The tongue restraint and position correction devices described herein are dental devices that may include an attachment mechanism for (preferably releasably) attaching a dental device to specific patient teeth.

The connecting element connecting the first and second surfaces of the fastening mechanism may, however, need not be made of the same resin material and the first surface of the fastening mechanism. In fact, it may, but need not, be a simple extension of the first surface enclosing the last upper tooth and merging with the corresponding second surface. As shown, the connecting element is not located between adjacent teeth. As described, the connecting member may be a resinous material, or may be formed from another material such as a metal wire, etc.

The restraining mechanism may include a component stretched between the left and right surfaces of the attachment mechanism (and the left and right sides of the dental arch) and located approximately in the occlusal plane of the patient's mouth, limiting the range of motion of the tongue. The dental devices described herein may be shaped to suit the unique anatomy of the individual, tongue deformity and resulting oral morphology and dysfunction, and may be selectively adjusted during treatment to correct the patient's tongue movements, whereby some medical conditions are improving.

The following description relates to dental devices and methods for limiting and correcting the position of the tongue. These devices and methods are now described in more detail with reference to the accompanying drawings, which provide one or more illustrated embodiments and/or arrangements of devices and techniques. The apparatuses and methods are in no way limited to the illustrated embodiments and/or arrangements, as the illustrated embodiments and/or arrangements described below are merely examples of the present apparatuses and techniques, which may be implemented in various forms, as will readily be understood by those skilled in the art. . Thus, it should be understood that any structural or functional details disclosed herein should not be construed as a limitation of the present application, but rather as a representative embodiment and/or arrangement of the inventive concept for the implementation of the present devices and/or methods by a person skilled in the art. in one or more ways. Furthermore, just because a particular feature is presented in combination with a particular set of other features, it is not intended to limit the invention and each feature may be combined with a different set of other features. Accordingly, certain aspects of the present devices and methods may take the form of a hardware-only implementation or a combination of software and hardware implementation.

Definitions.

The following terms and phrases have the meanings given below unless the context clearly defines otherwise.

"Posterior region" in a general sense means the region of the oral cavity from the distal end of the first molar to the place where the tongue drops sharply down.

"Anterior region" in a general sense means the region of the oral cavity from the incisors to the mesial end of the first premolars.

"Central region" in a general sense means the region of the oral cavity from the mesial end of the first premolars to the distal end of the first molars.

"Lateral ribs" in a general sense means the left and right sides of the tongue.

"Tip" in a general sense means the extreme front of the tongue.

"Mostly circumferential" means, in at least one embodiment, a partial circumferential circumference of the maxillary (or mandibular) dental arch, leaving the lingual side of at least the anterior teeth uncovered, yet enclosing the lingual side of at least one posterior tooth (and preferably two or three posterior teeth).

"Arch" in a general sense means a set of upper (or lower) teeth of a person or animal.

"Distant corresponding tooth" generally means one or more teeth in the posterior region of the mouth. In one embodiment, the corresponding posterior tooth is a molar.

"Connector" generally means the part of the dental device that connects the first surface and the second surface of the dental device. In some embodiments, the connector at least partially encloses a posterior region, such as a back tooth or teeth.

"Occlusal plane" in a general sense means an imaginary surface that theoretically touches the edges of the incisors and the tops of the occlusal surfaces of the posterior teeth. The occlusal plane represents the average value of the curvature of the surface.

"Three-dimensional space" in a general sense means volume.

"Tissue" can in a general sense mean teeth, gums, palate, or tongue; "soft tissues" means the palate, gums, and tongue, unless the context calls for only the gums and palate (for example, when describing wings).

"C-shaped" may refer generally to any curved or three-sided straight shape and may also include a "U-shaped" shape.

"Oral", when applied to the tongue, includes both the buccal (oral) and pharyngeal (down towards the pharynx) parts of the tongue.

“Lateral expansion”, when applied to a component, means expansion of the length of the component in such a way that the device exerts lateral (i.e., transverse to the sagittal plane) pressure on the dental arch, thereby promoting similar lateral (transverse) palatal expansion.

Description of some embodiments.

Various embodiments of the present application are described in detail herein with reference to the drawings, with like reference numbers designating like parts and assemblies throughout the series of drawings. The present invention relates to one or more dental devices and one or more methods of using dental devices. Dental devices are described in the context of the oral cavity (buccal cavity) of the patient who will wear the device. In one or more embodiments, one or more dental devices may be used in one or more treatments for various medical conditions associated with oral and/or mandibular disorders.

Fig. 1A-B represent various aspects of a patient's dental arch. Fig. 1A is a side view of the left side of the upper and lower dental arch, and FIG. 1B is a bottom view of three teeth on the left side of the patient's upper arch. As represented by the numbering in FIG. 1A, each side of the patient's mouth typically has 8 teeth on each side of the upper arch and 8 teeth on each side of the lower arch. In this regard, the dental devices of the present invention are described herein in relation to a person who has 8 teeth on each side of the upper dental arch; however, it should be understood that the dental device may be used by patients who have more or less teeth than the norm. As shown in FIG. 1B, each tooth is generally oriented in the arch so that it has a "mesial side" (the side towards the "anterior midline" i.e. the line between the front two teeth defining the left and right side of the dental arch) , "distal side" (side towards the backmost tooth), "lingual side" (side adjacent to the tongue) (or "palatal side"), and "buccal side" (side adjacent to the inside of the cheek or lip). When used in connection with a device, the terms "left" and "right" will mean the side of the device when worn, which would then correspond to the left and right sides of the user's dental arch and, more broadly, to the mouth and oral cavity.

Attachment mechanism.

In accordance with one or more embodiments, the dental devices of the present application include an attachment mechanism that secures the dental device to a dental arch in a patient's mouth. In one or more embodiments, the attachment mechanism is configured to be secured to a patient's upper dental arch and then removed to secure the dental device to the patient's dental arch. The attachment mechanism, however, does not prevent contact between the upper and lower dental arches.

The attachment mechanism may include a primarily but not entirely circular band located on or near the patient's dental arch (e.g., when wearing the device, the attachment mechanism may cover all or all of the buccal visible (crown) surface of the buccal surfaces of the upper teeth. Although the mechanism the fasteners may overlap the gum a little, this is not desirable as this creates inconvenience for the patient.The fastening mechanism preferably does not enclose the bite (chewing) surfaces of the teeth, providing maximum intercuspid occlusion and providing a more natural cutting, grinding and chewing function.However, embodiments, covering also chewing surfaces (and optionally also all lingual surfaces of the upper teeth) can be provided and is within the scope of the present invention.Regarding the lingual side, in some preferred embodiments, the second surfaces of the attachment mechanism also cover a limited number of back teeth, regardless of whether how the dorsal section of the component is directed - forward or backward.

The attachment mechanism is attached to the dental arch and, with the possibility of subsequent removal, is held there by pressure, slightly compressing the molars used for attachment. The attachment mechanism can be easily removed by the patient by applying pressure and is easy to wear and remove as it leaves the lingual surfaces of most of the patient's teeth exposed. This gives the patient a more natural feeling. The dental devices described herein may also include a removable restrictive mechanism connected to the attachment mechanism. Teeth used for attachment, preferably at least one posterior tooth on each side of the patient's upper arch. Typically two teeth or even three teeth on each side. However, the goal of some embodiments is for the lingual surfaces of the remaining teeth, and in particular the anterior teeth, to remain uncovered. Similarly, as stated above, the lingual surfaces of a large majority of the upper teeth are uncovered, whereby the lingual surfaces of the teeth are mostly exposed. This provides several advantages: the tongue can contact the incisive papilla, which promotes physiological proprioception; the device is more flexible and more convenient, easy to wear and take off; less resinous material is required to make the device; the lingual surfaces of the upper teeth (except for the teeth for attachment) remain open to the tongue, so that the sensation of "foreign body in the mouth" of the user is not so strong; and essentially full contact between the upper and lower teeth is allowed, whereby the function of chewing, grinding and cutting is maintained, which provides a natural feeling, as opposed to whitening retainers, mandibular thrust splints or modern orthodontic aligners or retainers currently available on the market , such as InvisalignTM, which cover the entire surface of the tooth.

Various aspects of the attachment mechanism, in accordance with one or more embodiments, are shown in FIG. 2A-5B.

Fig. 2A is a bottom view of a dental device attachment mechanism 200 to an upper dental arch, in accordance with one or more embodiments. Referring to FIG. 2A, the attachment mechanism 200 includes a primarily circular tape ("circular tape") 205. In one or more embodiments, the circular tape 205 comprises a resinous material (e.g., a polymeric material such as an acrylic resin tape, preferably translucent or transparent), in contact with the upper dental arch when wearing a dental device. In one or more embodiments, the entire circular band 205 is made from a resinous material. In at least one embodiment, one or more sections of the circular belt 205 are made from a resinous material. In one or more embodiments, the predominantly circular band 205 contacts the buccal side of the upper arch. The removable tape serves to fix the device on the dental arch.

In general terms, the material for the attachment mechanism, and in particular the surface of the tape, and optionally also the connecting element, is any physiologically acceptable, preferably medical grade (with an optional antibacterial additive), resinous material, solid in the temperature range of its use ( for example, with a melting point above about 125 degrees C), with a bulk density approximately equal to that of water, a tensile strength in the order of from about 50 to about 80 and preferably about 60 mPa with an elastic modulus above 2 hPa, and preferably from 2 to 3 hPa, with a Knoop hardness of minerals from about 18 to about 20, good optical properties (preferably of a light and transparent material, optionally colored), with sufficient elasticity to allow easy donning and removal by simple hand pressure, and adequate resistance to oxidation and more broadly with the proper aging characteristics to be in the oral environment (exposed to air, food and oral fluid) for at least 18 months and preferably for 2 years without substantially losing mechanical properties.

The circular band 205 includes a first surface 210 adapted to be positioned buccally on the upper arch when the device is worn, and preferably generally corresponding to the buccal surface of dental crowns. Circular band 205 also includes a pair of second surfaces 215 which, in use, will be located along the lingual side of at least one posterior tooth (eg, a posterior molar tooth) on each side of the upper arch. In other words, the circular band 205 includes a left second surface that will be located on the lingual side of at least one back tooth on the left side of the upper dental arch, and a right second surface that will be located on the lingual side of at least one back tooth on the right side. upper dental arch. In the embodiment shown in FIG. 2A, a pair of second surfaces 215 are adapted to be positioned along the lingual side of the three most posterior teeth on each side of the upper dental arch. The second surfaces 215 of the attachment mechanism do not interfere with tongue contact with all of the teeth in the region of the second surfaces 215. As stated above, typically each of the above first and second surfaces encloses one, two, or three of the rearmost teeth. Longer surfaces may be used as long as they facilitate the anchoring function and are not uncomfortable. However, it is desirable to maintain contact between the tongue and the teeth, limiting the number of teeth covered by the first and second surfaces by limiting the length of these surfaces without impairing the attachment function. The latter provides for tight fixation with the possibility of subsequent removal by exerting slight pressure on the user's hand.

It should be appreciated that the circular band 205 may be in the form of a plurality of discontinuous resinous sections or lengths. Specifically, and in accordance with one embodiment, the circular band 205 may be formed from a first resinous segment that extends along the first surface 210, a second resinous segment that extends along one of the second surfaces 215, and a third resinous segment that extends along the other. second surface. Clearly, by segmenting the second and third resinous segment, a gap is created between them along the second surface 215 such that the curved front of the first resinous segment does not have a corresponding resin segment along the second surface facing this first surface. By segmenting the resinous segment along the second surface 215 into two discontinuous segments, the rigidity of the device is reduced because if the resinous segment were to cover the entire second surface, the dental device would have a rigidity that is not desirable for many devices. Between the first resinous segment and the second resinous segment there is a space to receive teeth and a space between the first resinous segment and the third resinous segment to accommodate other teeth (see Fig. 2C, for an illustration of teeth protruding above the resinous segment). Thus, the teeth can be placed between the resinous segments. The three resinous segments are thus not in direct contact with each other, but are connected to each other by means of a connecting element, described below. On the other hand, a continuous, one-piece circular belt is possible, as shown, for example, in FIG. 12A, wherein the connector is a piece of tape connecting the buccal surface to the lingual, left or right, surface.

Continuing to refer to FIG. 2A, circular band 205 may also include a connector 220 that connects to first surface 210 and second surface 215. In one or more embodiments, connector 220 connects to or connects to first surface 210 and second surface 215 on the outermost tooth each sides of the upper dental arch. In one or more embodiments, connector 220 may extend from the middle of the distal side of the posteriormost tooth to the full length of the buccal and lingual sides of the posteriormost of at least one maxillary tooth. In at least one embodiment, the connector 220 may further extend the entire length of the buccal and/or lingual sides of the second or also the third outermost tooth on each side of the upper dental arch. In one or more embodiments, connector 220 may be a wire (e.g., a stainless steel wire, preferably medical grade steel, or a specialty steel alloy such as Elgiloy™ (Co-Cr-Ni alloy manufactured by Elgiloy Specialty metals, g (Elgin, Ill.) In some embodiments, the wire may be in the form of a continuous wire connecting first surface 210 and second surface 215, or may be in the form of segmented wires each connecting first surface and one second surface 215. In some embodiments, the wire may be immersed in the resinous material of the circular band The wire may be positioned within the resinous material of the circular band in such a manner that it primarily abuts the middle of each tooth that it surrounds.

In the above embodiment, one connector 220 connects the first resinous segment to the second resinous segment, and one connector 220 connects the first resinous segment to the third resinous segment.

In one or more embodiments, the height of the circular band 205 is approximately 2-4 mm so as not to cover the entire exposed buccal surface of the upper arch teeth, and preferably remains below the gum line. In at least one embodiment, the circumferential band 205 may have a height of about 1-2 mm for patients with an under-arch, or about 4-6 mm for patients with an over-arch. In one or more embodiments, the attachment mechanism 200, including the circular band 205, can be custom-made according to the specific measurements of the patient's upper arch. Accordingly, the attachment mechanism 200 may be individually sized and shaped to be secured to a patient's upper dental arch and subsequently removed from the patient's dental arch.

Fig. 2B-C are side views of a fastening mechanism in accordance with at least one embodiment. In particular, Fig. 2B is a side view from inside the dental arch showing the lingual side of the attachment mechanism including the second surface 215 and the connector 220 attached to the second surface 215. FIG. 2C is a side view from inside the dental arch showing the buccal side of the attachment mechanism including the first surface 210 and the built-in connector 220.

In at least one embodiment, the attachment mechanism 200 may include an arcuate support member conforming to the contour of the patient's palate (i.e., palate). The arcuate support element is located between the pair of second surfaces and is connected to the lingual side of the second surfaces.

Fig. 3A is a bottom view of an embodiment of a dental device attachment mechanism 200 incorporating an arcuate support member, in accordance with one or more embodiments. As shown in FIG. 3A, attachment mechanism 200 includes an arcuate support member 225 stretched between and attached to second surfaces 215. In one or more embodiments, the arcuate support member 225 flexes upwardly to conform to the contour of the patient's palate, but preferably does not touch the palate, preventing user discomfort. The arcuate support member provides increased rigidity, strength, and support for the dental device. In one or more embodiments, and as shown in FIG. 3A, the arcuate support member 225 may be an arch made of a resinous material. In some embodiments, the length of the arcuate support may be approximately equal to the length of the second surface, and in at least one embodiment (as shown in FIG. 3A), the width of the arcuate support 225 may be equal to the length of the second surfaces 215 in that that, in this particular embodiment, the width of the arcuate abutment 225 does not extend the full length of the second surface 215 (however, it may if the number of teeth spanned by the surfaces 215 decreases).

Fig. 3B-C is a side view of an attachment mechanism having an arcuate support member 225, in accordance with at least one embodiment. In particular, Fig. 3B is a side view from inside the dental arch showing the lingual side of the attachment mechanism 200 including an arcuate support member 225 attached to the second surface 215. This view also shows the connector 220 attached to the second surface 215. FIG. 3C is a side view of the outside of the dental arch showing the buccal side of the attachment mechanism including the first surface 210 and the integrated connector 220, however the arcuate abutment is not visible (which is optional anyway).

In at least one embodiment, the circular band 205 may include a wing attached to the lingual side of one or both of the second surfaces. The wing may be configured to hold one or more sensor devices (sensors), as described below. In one or more embodiments, the wing may be made of resin material, like the rest of the circular tape, and the sensor may be embedded within the resin material of the wing or otherwise attached to the wing. In at least one embodiment, the wing does not contact the palate or tongue because the tongue is under pressure when the device is worn. In this regard, the sensor embedded in the wing can function without touching the tissues (eg, palate, tongue) of the patient wearing the dental device. Fig. 5A shows an exemplary wing structure. Two wings may be included, as shown, for symmetry and proprioception, or to accommodate more sensors than one wing can accommodate, if such a plurality of sensors is preferred.

One or more sensors may be used to monitor various aspects of the oral cavity while wearing the dental device, including temperature, pH, and/or sound (sound sensor evaluates snoring; pH sensor measures pH to evaluate mouth breathing). For example, a temperature sensor may be incorporated into the wing of the circular tape to periodically measure the temperature in or near the dental device. The temperature sensor may be used to monitor the patient's compliance with the requirements for regular use of the dental device. For example, if the temperature sensor detects that the temperature in or near the device is approximately 35-38°C (95-100.4°F), this indicates that the device is currently being used by a patient. However, if the temperature of the sensor is well below this temperature range, such as 20-22°C, the device is most likely not being used by the patient. The temperature sensor may also be configured to evaluate mouth breathing and nasal breathing of the user. For example, if the temperature sensor detects that the temperature in or near the device is approximately 35-38°C (95-100.4°F), this means that the user of the dental device is predominantly nasal breathing. On the other hand, if the temperature sensor determines that the temperature in or near the device is approximately 30-35°C (86-95°F), then the user of the device is most likely mouth breathing. To ensure the accuracy of the temperature reading of the temperature sensor, the sensor does not come into contact with the tongue or gums of the users so that the temperature readings are not affected by the user's tissues. An exemplary sensor device (sensor) 230 is shown in FIG. 4 in accordance with at least one embodiment.

The sensor may be of different sizes and shapes depending on the size of the wing to which it is connected on the dental device. In embodiments where an arcuate support is provided, one or more sensors may be built into the arcuate support. For example, in an exemplary embodiment, the sensor may be 9mm x 13mm. The sensor may include various features including, but not limited to, a processor, memory, antenna, and/or battery. In one or more embodiments, the sensor may be configured to connect wirelessly to one or more remote computing devices. For example, metrics collected by a sensor may be transferred to one or more remote computing devices via a radio frequency identification (RFID) tag attached to the sensor device. One or more of the sensors in the present dental device may include hardware and/or software components that may be commercially available.

For example, miniature wireless sensors subject to induced battery charging are commercially available and have been described, for example, in Arbinger FX et al., a Fraunhofer Society publication titled "Wireless Charger Chip for Smart Card Devices" (https://www. .iis.fraunhjfer.de/content/dam/iis/de/doc/lv/…/wireless_battery_charger.pdf last accessed July 1, 2017, incorporated in its entirety by reference). The touch device includes the following components, each of which performs the following function or functions: housing; waterproof microprocessor processing and memory unit (MCU) for data input, processing and storage; a temperature sensor for obtaining temperature readings (and/or a sonic or pH sensor for generating other relevant data, if necessary, more than one sensor device); a communications module including RFID and an antenna (provided with reference to an appropriate frequency, such as 13.56 MHz); charging module and rechargeable battery; as well as an optional switch. The above components are either commercially available or their design and contraction is within the art. It should be borne in mind that this type of sensor can be built into the instruments of the present invention.

Fig. 5A-B are an exemplary attachment mechanism including two wings and a sensor in accordance with at least one embodiment. In particular, Fig. 6A is a plan view of the attachment mechanism 200 including a wing 235 attached to every second surface 215 and a sensor 230 embedded in the wing 235 of the right second surface. In one or more embodiments, and as shown in FIG. 6A, the wing 235 is made of resin material, and the resin wings are fused to the resin material of their respective second surfaces 215. In one or more embodiments, the wings 235, like the rest of the attachment mechanism 200, may be individually sized and shaped so as to place the sensor. If the sensor is missing, the wing is not required; in any case, the sensor is optional. The two wings can be used for additional sensory functions or simply for symmetry and proprioception. In an exemplary embodiment, the wing may have a length of approximately 13-15 mm at the base and approximately 8-9 mm at the top, and a thickness of approximately 3 mm. Its base is attached (ie, fused) to the second surface, with the wing protruding obliquely and may taper towards the top of the second surface so as not to obstruct the tongue or touch the palate or teeth. Fig. 5B is a side view of the second surface of the attachment mechanism of FIG. 5A showing the tongue side of the mechanism including the sensor 230 embedded in the wing of the right second surface 235.

limiting mechanism.

The dental devices of the present application also include a restraint mechanism, preferably removably attached to the attachment mechanism by means of a locking mechanism. In one or more embodiments, the pair of ends of the restraint wire are responsible for fixing the restraint to the left and right second surfaces of the attachment mechanism such that the restraint is able to be held in place by tongue pressure. The restraint mechanism includes a component (eg, wire) stretched between a pair of second surfaces 215 of the attachment mechanism and located approximately in the occlusal plane of the user's mouth.

Positioning the component approximately in the occlusal plane limits the range of motion of at least part of the tongue. In general, the restraint mechanism forces the user's tongue to align over time and also lifts the tip slightly upward such that the apex of the tongue (tip of the tongue) is at the superior incisive papilla when the tongue is at rest. Using a number of different components for the limiting mechanism and/or adjusting the position of the limiting mechanism, the tongue gradually moves forward and/or downward. During the tongue alignment process, as the tongue pushes through the restraint, some of the upward force will be converted into a slight horizontal, outward force by the restraint, which can cause (needed) lateral or transverse expansion of the palate and make the palate shallow. This outwardly oriented force from the restraint mechanism is in addition to the lateral force exerted by the sides of the tongue on the molars when the instrument is worn by the user.

The component may be reverse (reverse) or forward, depending on the treatment plan for the type of language-related condition requiring correction. In particular, when the component is directed forward, the component is centrally located with respect to the second surfaces and the front section of the circular tape. In addition, the forward component is located in the central part of the tongue approximately in the user's occlusal plane. When the device is worn, the forward-facing component is configured to restrict movement of the central region of the tongue and thereby narrow the range of motion of the tongue to a more limited three-dimensional space relative to the space in which the tongue typically moves. The direct component restricts the movements of the central region of the tongue, but still allows the tip and lateral ribs of the tongue to perform the movements necessary for speech and swallowing. The forward component is spanned between and abuts at least a portion of the left and right second surfaces.

In turn, the backward directional component is configured to restrict movements of the posterior region of the tongue and thereby narrow the range of motion of the user's tongue to a more limited three-dimensional space relative to the space in which the tongue would typically move in the absence of a dental device. The reverse component restricts the movements of the posterior region of the tongue, yet still allows at least the anterior and central regions and the lateral ribs of the tongue to perform the movements required for speech and swallowing. The reverse component is strung between and attached to the left and right second surfaces of the back of the dental device.

A component, forward or reverse, is generally a metallic wire. The metal wire may be made from one or more metals. For example, the metal wire may be made of stainless steel, titanium molybdenum alloy, Bendalloy® or Elgiloy®. In an exemplary embodiment, the wire may have a diameter of 0.9 mm. However, in other embodiments, the diameter of the wire may be different depending on the anatomy and/or condition of the user and the required flexibility of the component. In one or more embodiments, at least a portion of the metal wire is coated with a resinous material (eg, acrylic resin) that provides increased comfort and tolerability of the dental device to the user, thereby increasing user compliance. In one or more embodiments, the component, regardless of orientation, is typically C-shaped with the dorsal portion of the component transverse to the longitudinal axis of the device. The dorsal section of the component is mainly responsible for the restriction of tongue movements.

The component is generally more flexible in the dorsal region to accommodate changes in the width of the dental arch during wear of the dental device. In contrast, the ends of the restraint mechanism are generally stiffer than the dorsal region, since the design of the ends is designed to withstand the powerful upward forces exerted by the tongue.

It should be noted that the positioning as well as the length and size of the restraint mechanism component in the user's mouth, and in particular the positioning of the tongue acting component, is determined considering the morphology and dysfunction of the patient's oral cavity. Thus, the absolute dimensions of the limiting mechanism (and the dental device as a whole) in mm, indicated in the text of this document, are approximate and can be changed for the specific morphology of the patient's oral cavity.

Directional limiting mechanism.

An exemplary forward directional limiter is shown in FIG. 6A-6C. Fig. 6A represents the length, in mm, of examples of direct limiting mechanisms. In particular, Fig. 6A represents the length of a straight short limiter (FwS) and a straight forward long limiter (FwL) in accordance with one or more embodiments.

Fig. 6B is a front view of an exemplary straight forward limiting mechanism, and FIG. 6C is a bottom view of an exemplary straight forward limiting mechanism. As shown in FIG. 6B-C, the limiter mechanism 300 includes a forward directional component 305. In this embodiment, component 305 is C-shaped and includes a dorsal portion 310. In addition, in this embodiment, component 305 includes a wire in which a section of the wire (for example, most of the dorsal portion 310) is coated with a resin coating (for example, resin material) 315. In one or more embodiments, the resin coating 315 has a thickness of approximately 1-2 mm around the wire.

In one or more embodiments, and as shown in FIG. 6B-C, the dorsal portion 310 may include a central brace 320 to provide flexibility and optional lateral expansion of the component in the user's mouth. The dorsal portion 310 also includes a apex 325, which in this embodiment is the open edge of the central brace 320. The central brace 320 also includes a closed edge 330 such that the closed edge 330 is directed backwards (i.e., reversed) relative to the dorsal portion. 310. In other words, in the embodiment shown in FIG. 6B-C, the center brace 320 includes a reverse arch attached centrally or forming part of the central region of the dorsal portion 310 of the component 305. The top 325 of the component is the point of maximum tongue pressure. As shown in FIG. 6B-C, the resin coating 315 covers most of the dorsal portion 310 but not the center brace 320, allowing for increased width flexibility. The center brace 320 also provides lateral flexibility to the component as it is located in an upward direction at a 30-50° angle relative to the plane of the component 305 and is directed away from the user's incisors. Accordingly, when the dental device is in use, the center brace 320 does not contact the user's palate or the user's tongue when the tongue is at rest. The restraint mechanism 300 also includes a pair of wire ends 335 configured to removably connect the restraint mechanism 300 to the attachment mechanism 200, as described in detail below. The center brace can be presented in a backwards component, however the geometry will be reversed, the opening of the center brace will point towards the posterior end of the user's mouth and the angle of the component may need to be adjusted. This is illustrated in FIG. 12D. Component 505 is directed in the opposite direction. In this embodiment, the center brace 520 is provided with a closed edge 530. The "free" component 505' in FIG. 12D is presented to illustrate a shorter reversed component including a center brace.

In at least one alternative embodiment, the restraint mechanism 300 may also include a pair of vertical (or oblique) hinges (limiters) (not shown), one on each side of component 305. A pair of oblique or vertical hinges are shown as part of a component (e.g., wires), however, they are a feature of the adjustment mechanism and are located in the end section of the limiting mechanism in close proximity to the second surfaces of the attachment mechanism. The vertical hinges provide additional vertical flexibility such that component 305 and center brace 320 can be adjusted up or down 30° (from about 0° to about 30° from the occlusal plane (or from the plane defined by the end portions 335 of component 305. B therefore, in the present embodiment, oblique or vertical hinges serve as part of the adjustment mechanism.In one or more embodiments, oblique or vertical hinges may include a thin (e.g., 1 mm) silicone coating around the hinges.Vertical or oblique hinges are illustrated in FIG. 11A-C in connection with the reverse component, however, the same can be included in the corresponding positions of the forward component.In the absence of vertical hinges, vertical adjustment can occur by bending the end parts of the component to change the angle of the component to the basal plane given by these end parts.

The limit mechanism 300 illustrated in FIG. 6A-C has a design that provides flexibility to allow lateral (ie, transverse to the sagittal plane) expansion of the dental arch as a result of use of the dental device. In particular, when the user's palate is too narrow, the pressure exerted by the tongue, assuming a flattened and more approximate shape/position under pressure from component 305, can cause the dental arch to enlarge over time as the tongue assumes a closer to normal position and returns to him. In particular, when using the appliance, the dental arch can expand when the tongue flattens, as resistance to the tongue from the component can cause the tongue to exert a lingual lateral force on the molar teeth. Accordingly, the component 305 (eg, wire) must be sufficiently flexible in the transverse direction so that the expansion of the dental arch is not blocked by the tongue. In this regard, the lateral flexibility of the component wire, given by the opening of the center brace, allows for lateral expansion of the dental arch without the component directly exerting either a restraining force or an expanding force on the molar teeth. In one or more embodiments, the restraint mechanism 300 having a forward directional component 305 can be adjusted laterally by up to approximately 5 mm by slightly opening the center brace 320, if any. This can be done by an orthodontist or dentist. Optionally, the staple may be placed (e.g., by immersion) in a “drop” or coating of resinous material (not shown in Figures 6 or 7, but shown in Figures 8A-C with no staple, appropriately illustrating the principle) to extra comfort. The drip/coating may be removed prior to adjustment and a new coating may be applied.

In one or more embodiments, when tongue dysfunctions persist, the restraining mechanism may be adjusted downwards by up to 35° (measured from the center or top of the component relative to the plane defined by the end portions of the component) to increase pressure on the tongue. This adjustment can be made manually by the dentist using, for example, oblique or vertical loops such as 340 (or 540 for a reverse component) or, in the absence of loops, by changing the angle between the ends of the component, such as 335, and the C-shaped section of component 305.

Fig. 7A-C represent an exemplary dental device, including a straight forward limiting mechanism 300, in accordance with one or more embodiments. As shown in FIG. 7A-C, the restraint mechanism 300 is removably secured to the attachment mechanism by the locking mechanism 400. In addition, the restraint mechanism 300 is positioned centrally with respect to the pair of second surfaces 215 of the circular band 205, and more specifically, the component 305 of the restraint mechanism 300 is stretched between the pair of second surfaces 215. Component 305 is configured to be located approximately in or at an angle to the user's occlusal plane. In addition, the top 325 of the dorsal portion 310 is located in the central region of the tongue. The direct directional restraint mechanism 300 is configured to restrict the movements of the central portion of the tongue, thereby restricting the tongue's range of motion to a limited three-dimensional space and forcing the tongue to lie flat. However, while wearing the dental device, the restraint mechanism 300 still allows the tip and side ribs of the tongue to perform the movements required for speech and swallowing.

As stated above, FIG. 7A-C show a dental device locking mechanism 400 and its positioning and attachment to, on the one hand, the fastening mechanism 200 and, on the other hand, to the forward restraint mechanism 300, in accordance with at least one embodiment. In the embodiment of FIG. 7A-C, the attachment mechanism includes one or two wings 235 fused to the resin material of the respective second surfaces 215 and a sensor 230 embedded in one of the wings 235. The sensorless wing has no function other than to give the user the impression of symmetry. It may not be used. The sensor wing can also be left unused if the sensor is not used. As shown in FIG. 7A-C, the locking mechanism 400 may be positioned lingually on the second surfaces 215 of the locking mechanism, spanning one or more of the three molars.

Fig. 7A shows a forward restraining mechanism 300 attached to the attachment mechanism 200 by the locking mechanism 400 in an anterior position so that the apex of the dorsal portion 310 (in this case, the central brace 320) is adjacent to the second premolar and located primarily in front of the three molars. Fig. 7B shows the direct limiting mechanism 300 attached to the attachment mechanism 200 by the locking mechanism 400 in a more rearward position relative to the positioning in FIG. 7A such that the apex of the dorsal portion 310 (eg, the central brace 320) is adjacent to the first molar and located primarily behind the premolars. Accordingly, as shown in FIG. 7A and 7B, the position of the restraint mechanism 300 in the user's mouth can be adjusted by changing along the ends of the wire 335 and (preferably removably) secured in position by the locking mechanism. On FIG. 7A, the end portion of the wire 335 is secured by the locking mechanism 400 in a position in close proximity to the edge of the dorsal portion. In contrast, in Fig. 7B, the end portion of wire 335 is secured by locking mechanism 400 to or near the distal end of wire 335. In one or more embodiments, the restraint mechanism can be adjusted between a forward position (FIG. 7A) and a rear position (FIG. 7B), and can be positioned at one or more points between the illustrated forward and rear positions. Fig. 7C is a side view of the dental device from inside the dental arch showing the lingual side of the attachment mechanism and the restraint mechanism.

In one or more alternative embodiments of a direct restraint dental device, the dorsal portion of the component may be curved and not include a central brace. An example of an embodiment of a straight forward restraint mechanism without a clevis is shown in FIG. 8A-C. If necessary, a slight lateral adjustment can be made by slightly leveling the curve of the dorsal portion of the component.

Fig. 8A represents the length, in mm, of exemplary direct restraint mechanisms without shackle. In particular, Fig. 8A represents the length of a straight short limiter (FwS) and a straight forward long limiter (FwL) in accordance with one or more embodiments.

Fig. 8B-C are a perspective view (8B) and a bottom view (8C) of exemplary straight forward restraint mechanisms without a brace, in accordance with at least one embodiment. As shown in FIG. 8B-C, the limiting mechanism includes essentially the same features as the embodiment of FIG. 6A-C (and thus like elements have like numbering), including a C-shaped component 305 with a dorsal portion 310 with an apex 325. In this embodiment, the central portion of the dorsal portion 310 is coated with resin coating 315. In one or more embodiments, embodiment, the resin coating 315 has a thickness of approximately 1 mm around the wire. The restraint mechanism 300 also includes a pair of wire ends 335 configured to be detachable to connect the restraint mechanism 300 with a locking mechanism. More specifically, as in the previous embodiment, the pair of ends of the wire 335 are bent and thus configured to enter the locking mechanism from the reverse direction, which provides increased flexibility and adjustability. In one or more embodiments, the component is inclined at an angle relative to the base of the attachment mechanism in the range of 0°-30°, and in some embodiments may be inclined at an angle of, for example, 15°.

Continuing to refer to FIG. 8B-C, in this embodiment, the direct restraint mechanism 300 also includes a pair of horizontal loops 340, one on each side of the component 305. The horizontal loops 340 are part of the component (eg, made of wire) and are not coated with resinous material. The horizontal hinges 340 allow lateral (expanding) adjustment of the restraint mechanism to allow for lateral expansion of the palate of the dental arch under the influence of the lateral ribs of the compressed tongue. In particular, when the user's palate is too narrow, the pressure exerted by the pressurized tongue from the component 305 can cause the dental arch to widen over time as the tongue flattens out. In particular, when using an appliance, the dental arch and consequently the palate may expand when the tongue is aligned, as pressure on the tongue from the component may cause the tongue to exert a lateral force on the lingual side of the molar teeth. Accordingly, the component 305 (eg, wire) must be sufficiently flexible such that the expansion of the dental arch is not blocked by the tongue. With a center brace, the component can expand laterally by opening the center brace. If, as in this embodiment, there is no center brace, the horizontal hinges 340 can be used to manually enlarge the component to the same effect. The hinge or brace allows for lateral expansion of the dental arch without the component exerting a direct restraining or expanding lateral force on the molar teeth. In one or more embodiments, the restraint mechanism 300, having a forward directional component 305, can be adjusted laterally by approximately 5 mm by slightly opening the center brace, if present. This can be done by an orthodontist or dentist. Optionally, if present, as shown in FIG. 7A, the brace may be placed (eg, by dipping) in a "drop" or covering of resin material for added comfort (not shown). A drop or coating, like 315 in FIG. 8A-C, however, enough to cover the staple, may be cut for adjustment and a new coating may be applied.

In at least one alternative embodiment, the limiting mechanism may also comprise a pair of vertical (or oblique) hinges (limiters) (not shown), one on each side of component 305. FIG. 8C, the vertical hinges will be located between the horizontal hinges 340 and fold into the component where the end portions 335 begin. ° from the occlusal plane. In one or more embodiments, the vertical loops may include a thin (eg, 1 mm) silicone coating around the loops. It should be noted that embodiments including the center brace do not have other horizontal loops in the restraint mechanism.

Locking mechanism.

In one or more embodiments, and as shown in FIG. 7, the restraint mechanism 300 is removably attached to the attachment mechanism 200 by a locking mechanism 400. The locking mechanism 400 may include a tension member such as a screw or a combination bolt and nut mechanism. Examples of the components of the locking mechanism 400 and the tension member are shown in FIG. 9A-C, in accordance with one or more embodiments.

As shown in FIG. 9A, in at least one embodiment, the locking mechanism may include a tensioning member that includes a pair of miniature tube nuts 405 (these nuts are commercially available), each containing a hole 410 and a bolt 415, for connecting appropriate points of the boundary wire. mechanism to the attachment mechanism. The locking mechanism is attached to the second surface of the locking mechanism by a metal tab 422 embedded in the material of the locking mechanism. More specifically, holes 410 receive respective ends (335, as shown, for example, in Fig. 7A or 535 as shown, for example, in Fig. 12A or 12B) of the limiting mechanism, and bolts 415 help hold the respective end parts 335 in place. as by tightening a bolt to secure (eg pinch) the end of the wire. In one or more embodiments of a forward-facing restraint mechanism, a pair of wire ends are folded back longitudinally toward the restraint mechanism and are thus configured to be inserted into the latch mechanism 400 from the reverse direction, despite the majority of the restraint mechanism being located in front of the latch mechanism. mechanism (see Fig. 7A). Such a curved configuration of the wire end portions of the limiting mechanism allows increased flexibility and adjustability with respect to the locking mechanism. In this regard, the bent ends of the wire 335 can slide back and forth within the tube nut 405 as part of an adjustment mechanism to adjust the position of the component relative to the back molars. The vertical adjustment of the component can be performed as described above using vertical hinges or by changing the angle of the end portions 335 to the C-shaped portion of the component, thereby adjusting the restriction of tongue movement. This provision applies to both forward and backward limiting mechanisms.

In an exemplary embodiment, the ends of the restraint mechanism are inserted into the locking mechanism such that the component is tilted at a predetermined angle, such as 15° relative to the plane defined by the ends of the component. In one or more embodiments, the size and shape of opening 410 allows entry of wire with a diameter of from about 0.5 to about 1.2 mm, preferably in the range from about 0.7 to 0.9 mm. However, in one or more embodiments, the holes may be sized and shaped to accommodate different gauge wires.

In one or more embodiments, the tube nuts 405 may be welded, embedded, or otherwise attached to the tongue portion of the respective second surfaces of the circular band of the attachment mechanism. More specifically, in at least one embodiment, tube nuts 405 may be attached, in a vertical direction, to the second surfaces of a circular band adjacent to the mesial side of the respective second molars (see Fig. 7C). In other embodiments, tube nuts may be attached to the second surfaces of a circular band adjacent to the mesial side of the first or third molars. Fig. 7A-B represent the tube nut 405 adjacent to the middle of the first molar, however, in other embodiments, the tube nut 405 may be located at other positions along the lingual side of the molars, such as a position adjacent to the mesial margin of the second molar (see FIG. 7C). Thus, a range of positions is available along the left or right second surface where the tube nut 405 can be secured to the second surface.

In at least one embodiment, the locking mechanism may include a tab 422 (protrusion) embedded in the resin material of one of the first or second surfaces of the locking mechanism for locking mechanism to the locking mechanism. In one or more embodiments, the locking mechanism may also include a metal strip or tab 422 welded to the tube nut 405 and embedded in the resin material of the tongue portion of the locking mechanism. Tab 422 is thus a protrusion that extends radially outward from the body of the tube nut to provide a structure that can be attached to the resin structure. In at least one embodiment, the tension member includes a clip.

Referring to FIG. 9B, the locking mechanism may include a pair of sheaths 420, the two sheaths being attached to the lingual part of the respective second surfaces of the circular band by a metal tab 422. In FIG. 9B illustrates one sheet 420. The sheaths 420 include a groove 425 sized and shaped to accommodate and retain respective end portions 335 or 535 of the restraint wire. Thus, the grooves 425 allow the ends of the restraint wire to reciprocate within the groove 425. Accordingly, in one or more embodiments, the sheaths 420 (and their grooves 425) may be approximately 3 mm long to accommodate approximately 3 mm of end portions. limiting mechanism. However, in other embodiments, the shells may be shortened or lengthened to accommodate other lengths of restraint mechanism ends.

Referring to the embodiment of FIG. 9B, the tension member is configured to further secure the end portion of the restraint mechanism (e.g., 335 or 535) inserted into the trough 425. gutter 425.

In one or more embodiments, the sheath 420 may also form part of the tension element.

In particular, in an embodiment in which the restraint mechanism component has a vertical loop at each end segment (as detailed below), a rubber band may be used to wrap around one end of the sheath, and the other end may be stretched and wrapped around a corresponding vertical or oblique limiting mechanism loops for fixing and tightening the limiting mechanism in the shell. Fig. 9C shows an example of a rubber band 430 wrapped around a limiter loop.

In one or more embodiments, the sheath 420 is permanently secured (eg, embedded, directly, or with a tab 422 or other structure) in the resinous material of the second side of the attachment mechanism's tongue. The ends of the restraint sheath wire are tightly secured in the sheaths of the fasteners, holding the restraint in place. The limiting mechanism can be removed by removing the rubber band and pulling the ends of the wire out of the sheath groove.

Reverse limiting mechanism.

An exemplary reverse (rear) direction limiting mechanism is shown in FIG. 10A-C. Fig. 10A represents the length, in mm, of an example of reverse restraint mechanisms. In particular, Fig. 10A represents the length of the reverse short limiter (BwS) and the reverse long limiter (BwL) in accordance with one or more embodiments.

Fig. 10B-C are side views (B) and an elevated front view (C) of an example of a reverse restraint mechanism. As shown in FIG. 10B-C, in this embodiment, the limiter mechanism 500 has a reverse directionality component 505. Component 505 is typically C-shaped and includes a dorsal portion 510. Also, in this embodiment, component 505 is typically a wire in which the central leg of the component (i.e., most of the dorsal portion 510) ) may be coated with resin coating 515. In one or more embodiments, resin coating 515 is approximately 1-2 mm thick around the wire. In some embodiments, the cover 515 may be slightly thicker towards the top 525 of the dorsal region 510 relative to other covered regions. In one or more embodiments, the restraint mechanism 500 may be sized and shaped to generally conform to the shape of the back of the user's dental arch. In addition, the resin coating 515 can be shaped so that it does not have sharp edges and prevents pain in the user's tongue. In one or more embodiments, the component is inclined downward at an angle relative to the base of the attachment mechanism in the range of 0 to 30°, and in some embodiments, inclined at an angle of 15°. Instead of a combination of metal wire and resin material, the component can be made from polymer wire or tubing material having the required strength and flexibility (eg, polyether ether ketone (PEEK) polymer).

The reverse restraint mechanism 500 also includes a pair of wire ends 535 releasably configured to connect the restraint mechanism 500 to the attachment mechanism via a locking mechanism. In this embodiment, the pair of wire ends 535 are configured to be inserted into the locking mechanism from the reverse direction, providing increased flexibility and adjustability. In one or more embodiments, the shape and positioning of the reverse restraint mechanism 500 in the oral cavity can be manually adjusted by a dentist. For example, the backward restricting mechanism 500 can be adjusted to be positioned as far as possible towards the root of the tongue (e.g., closer to the lingual V-zone), thereby facilitating the effect of the dental device at or near the pharyngeal region (to correct certain conditions), however avoiding nausea or gag reflex. The angle of inclination can be corrected by changing the angle of the ends of wire 535 relative to the C-section component 505. The angle can be measured relative to the occlusal plane or the plane defined by the ends of wire 535.

Another embodiment of a reverse (rear) directed limiting mechanism is shown in FIG. 11A-C, the limiting mechanism having vertical or oblique hinges. Fig. 11A represents the length, in mm, of exemplary vertical hinge reverse restraints, in accordance with at least one embodiment. In particular, Fig. 11A is the length of an exemplary reverse short restraint (BwS) with vertical or oblique hinges and a reverse long restraint (BwL) with vertical or oblique hinges, in accordance with one or more embodiments.

Fig. 11B-C are rear (B) and raised front (C) views of an exemplary reverse restraint mechanism with vertical or oblique hinges. As shown in FIG. 11B-C, in the present embodiment, the limiting mechanism 500 mainly has the same features and characteristics as in the embodiment of FIG. 10A-C, but also includes a pair of vertical or oblique hinges 540, one on each side of component 505. In the illustrated embodiment, vertical or oblique hinges 540 are part of component 505 and are not coated with resin material and allow expansion of the limiting mechanism to change the angle. component 505 to the occlusal plane of the patient or the basal plane of the restraint mechanism defined by the ends of the wire 535. This adjustment can be made by varying the vertical loops to bend the component downwards relative to the occlusal plane to an angle from zero to a maximum of 30°. Adjustment can be made in the non-loop embodiment by bending the ends of the limiter wire to create or correct a given angle. Alternatively, another limiting mechanism with a predetermined angle determined to be appropriate may be replaced.

продольную регулировку ограничивающего механизма. Фиг. 12D представляет варианты воплощения с обратнонаправленным компонентом, как на Фиг. 12А, где компонент имеет центральную скобу 520 с отверстием 530 для боковой регулировки ограничивающего механизма, как описано в связи с Фиг. 7В для прямонаправленного компонента.Fig. 12A-D represent an exemplary dental device including a reverse restraint mechanism 500, in accordance with one or more embodiments of the present application. In particular, Fig. 12A-C show a reverse restraint mechanism 500 attached to the attachment mechanism 200 by a locking mechanism 400. In this embodiment, the attachment mechanism includes wings 235, with the right wing including a sensor 230. FIG. 12A shows a shorter embodiment of the limiter 500 (BwS) with the tip 525 of the limiter 500 adjacent to the distal margin of the second molars. On FIG. 12B shows a longer embodiment of the limiter 500 (BwL), with the apex 525 of the limiter 500 positioned posterior (behind the distal margin) of the third molars. Fig. 12C is a side view of a longer embodiment of the limiter mechanism 500 and represents the tongue side of the wing 235 and the sensor 230. In at least one embodiment, as shown in FIG. 12B, C, the built-in sheath 420 of the locking mechanism 400 in the lingual portion of the second surface may span substantially the entire length of the second surface, thereby providing

longitudinal adjustment of the limiting mechanism. Fig. 12D represents embodiments with a reverse component as in FIG. 12A, where the component has a center brace 520 with a hole 530 for lateral adjustment of the limiter as described in connection with FIG. 7V for a direct component.

In one or more embodiments, the dental device of the present application may have one or more additional features to tailor the dental device to a particular user or to correct a particular type of condition. For example, in one or more embodiments, the dental device may include buccal side covers for all teeth of the upper arch, and lingual side covers for all upper molars. These coatings do not cover the chewing surfaces of the upper teeth and therefore do not interfere with full occlusal contact of all teeth. In one or more embodiments, attachment of the dental device to the dental arch can be accomplished with minimal clamping force on only the upper incisors and last upper molars. This minimum pressing force is sufficient to hold the dental device in place, so that no other transverse, sagittal, or vertical force is required. In this regard, in the present embodiment, the dental device can be applied to both natural brittle and artificial implanted teeth and prostheses.

In one or more embodiments, the resin coating of the attachment mechanism and/or restraint mechanism may be treated with antimicrobial agents, such as antimicrobial agents or antifungal agents.

As used herein, "adjustment mechanism" means portions of the restraint mechanism and/or attachment mechanism used to adjust the angle of the restraint mechanism component relative to the patient's occlusal plane when the device is being worn. These component adjustments control the degree of tongue movement restriction. The term "adjustment mechanism" also includes portions of the limiting mechanism and/or attachment mechanism used to adjust the position of the component along the longitudinal axis of the device. For example, the limiter mechanism may be slidably mounted on the adjustment mechanism (e.g., the ends of the limiter mechanism are slidably mounted on the locking mechanism, including a sheath inside the second surface of the retaining mechanism) to allow adjustment of the position of the component along the longitudinal axis of the device (see Fig. Fig. 7A-B). Accordingly, the adjustment mechanism may include a locking mechanism (including a tension member), a limiter wire end portion, and a second surface of the locking mechanism, which in some embodiments may be configured to lock portions of the locking mechanism (e.g., sheath). In various embodiments, the adjustment mechanism may also include a pair of horizontal wire loops or a center brace for optional lateral extension of the component (see Fig. 8), a pair of oblique or vertical loops located in the end section of the restraint mechanism to adjust the top of the component upwards, or downwards, and the adjustment mechanism may also not include hinges, and vertical adjustment of the top of the component may occur by changing the angle of the limiter wire ends or by replacing with another component with a different predetermined angle.

Treatment.

Fig. 13A-D represent positions of a minor tongue pressure restraint mechanism component, in accordance with one or more embodiments. More specifically, FIG. 1 3A represents the position of slight pressure on the tongue relative to the dental arch and the vertical distance from the occlusal plane for a milking, straight forward restraint (FwL), and FIG. 13B represents the position of slight pressure on the tongue relative to the dental arch for a short, direct limiting mechanism (FwS). Likewise, FIG. 13C represents the position of slight pressure on the tongue relative to the dental arch of the tongue and the vertical distance from the occlusal plane for a short, reversed limiting mechanism (BwS), and FIG. 13D represents the position of slight pressure on the tongue relative to the dental arch for a long, reversed limiting mechanism (BwL). The designation "mm" means the vertical distance of the top of the component from the occlusal plane; the designation "Di4" means the distal edge of the tooth 4 and means how far forward the tip of the component; similarly, "Me8" means the mesial edge of tooth 8. The tooth numbering system is a European system in which the numbering starts with the middle incisor (1) and ends with the last molar (8) on the same side of the upper dental arch. Thus, tooth 4 is the first premolar. The same designations apply to FIG. 14A-D (where strong pressure on the tongue appears), 15A, 16A, 17A and 18A. Together, the above distance and the dental arch relative to the apex give a measure of the stiffness (intensity) of pressure on the tongue, and also indicate exactly where the pressure on the tongue is concentrated.

Fig. 14A-D represent positions of a high pressure tongue restraint mechanism component, in accordance with one or more embodiments. In particular, Fig. 14A represents the position of strong pressure on the tongue relative to the dental arch and the vertical distance from the occlusal plane for a long, direct limiting mechanism (FwL) and FIG. 14B represents the position of the strong pressure on the tongue relative to the dental arch and the vertical distance from the occlusal plane for a short, direct limiting mechanism (FwS). Likewise, FIG. 14C represents the position of strong pressure on the tongue relative to the dental arch and the vertical distance from the occlusal plane for a short, reversed limiting mechanism (BwS), and FIG. 14D represents the position of maximum tongue pressure relative to the dental arch for a long, reversed limiter (BwL).

Fig. 15A-F represent an exemplary treatment plan for the treatment of a tongue condition associated with snoring or obstructive sleep apnea (OSA), in accordance with one or more embodiments. Fig. 15A is an enlarged diagram of the shape of the tongue in an abnormal position showing tongue dysfunction associated with obstructive sleep apnea. In this state, as shown in FIG. 15A, the patient's tongue is abnormally placed in a high posterior position and the palate has a large, deep depression that can put pressure on the nasal fossa. This malposition of the tongue and associated palatal malformation is believed to be caused by abnormal (so-called atypical) swallowing movements of the tongue, which leads to an abnormally high position of the tongue at rest and is associated with the development of OAVS. Fig. 15B is a layout diagram of the pinnacle of the constraint mechanism component for each of the four steps (indicated by a series of dots, as well as numbers corresponding to each specific step) for treating the tongue condition shown in FIG. 15A. As shown in FIG. 15B, the top of the restraint mechanism component moves back and forth in translation with each stage of treatment to flatten the tongue, apply transverse force to the molars from the inside, correct swallowing movements of the tongue, and also position the tongue at rest, which may allow the palate to be remodeled to achieve less deep, close to normal morphology. The duration of each stage of treatment may vary depending on each individual patient and the individual morphology of the patient's oral cavity, as well as other factors described below.

Fig. 15C represents the position of the top of the restraint mechanism component relative to the tongue for the first stage of treatment. As shown, the component used for the first step is a forward short ("FwS") component, and the top of the component is positioned such that the front of the middle of the tongue is pressed down with downward force.

Fig. 15D represents the position of the top of the limiter component relative to the tongue for the second stage of treatment. As shown, the component used for the second step is a reverse short ("BwS") component, and the top of the component is positioned so that the back of the middle of the tongue is pressed down with downward force.

Fig. 15E represents the position of the top of the limiter component relative to the tongue for the third stage of treatment. As shown, the component used for the third step is a backward long ("BwL") component, and the apex of the component is adjacent to the distal last molar such that the root of the tongue is pressed downward.

Fig. 15F represents the position of the top of the limiter component relative to the tongue for the fourth stage of treatment. As in the third step, the component used for the fourth step is the BwL component, and the apex of the component is positioned distal to the last molar such that part of the tongue root is pressed downward.

Fig. 16A-G represent an exemplary treatment plan for treating a tongue condition associated with malocclusion and/or snoring, in accordance with one or more embodiments. Fig. 16A is an enlarged schematic representation of the shape of the tongue in an abnormal position associated with malocclusion and/or snoring. In such a state, as shown in FIG. 16A, the patient's tongue is in an abnormally high anterior position and the palate is deep, narrow. It is believed that such a violation of the position of the tongue and in some cases of morphology is caused by atypical swallowing movements of the tongue and an abnormal position of the tongue at rest. These dysfunctions are thought to contribute to malocclusion, obstructive sleep apnea (OSA), or sleep snoring. Fig. 16B is a layout diagram of the pinnacle of the restraint mechanism component for each of the five steps (indicated by a series of dots as well as numbers corresponding to each specific step for treating the tongue condition shown in Fig. 16A. As shown in Fig. 16B, the pinnacle of the restraint mechanism component moves backward translationally and down with each step of treatment to straighten the tongue, apply shear force to the molars from the inside, correct swallowing movements of the tongue, and correct the position of the tongue at rest.As in the previous example, the duration of each stage of treatment may vary depending on each individual patient and individual the morphology of the patient's oral cavity, as well as other factors described below.

Fig. 16C represents the position of the top of the limiting mechanism component for the first stage of treatment. As shown, the component used for the first step is a straight forward long ("FwL") component, and the tip of the component is positioned such that the portion of the tongue just behind the tip is pressed downward.

Fig. 16D represents the position of the top of the limiter component for the second stage of treatment. As shown, the component used for the second step is the FwS component, and the apex of the component is positioned such that the portion of the middle of the tongue (approximately adjacent to the mesial margin of the first molar) is pressed downward.

Fig. 16E represents the position of the top of the limiting mechanism component for the third stage of treatment. As shown, the component used for the third step is the BwS component, and the apex of the component is adjacent to the distal edge of the second molar such that the back of the middle of the tongue is further pressed down by downward force.

Fig. 16F represents the position of the top of the limiting mechanism component for the fourth stage of treatment. As shown, the component used for the fourth step is the BwL component, and the apex of the component is adjacent to the distal margin of the last molar such that the back of the tongue is further pressed down by downward force.

Fig. 16G represents the position of the top of the limiting mechanism component for the fifth stage of treatment. As in the fourth step, the component used for the fifth step is a BwL component, and the apex of the component is positioned distal to the last molar so that part of the tongue root is pressed downward.

Fig. 17A-D represent an exemplary treatment plan for treating a tongue condition associated with malocclusion and/or snoring, in accordance with one or more embodiments. Fig. 17A is an enlarged schematic representation of the shape of the tongue in an abnormal position associated with malocclusion and/or snoring or both. In such a state, as shown in FIG. 17A, the patient's tongue is in an abnormally high anterior position and the palate is deep, narrow. This change in morphology is associated with dysfunctions such as atypical swallowing movements and/or interposition of the tongue between the dental arches. Fig. 17B is a layout diagram of the pinnacle of the limiting mechanism component for each of the two steps in treating the tongue condition shown in FIG. 17A. As in the previous example, the duration of each stage of treatment may vary depending on each individual patient and the individual morphology of the patient's oral cavity, as well as other factors described below.

Fig. 17C represents the position of the top of the limiter component relative to the tongue for the first stage of treatment. As shown, the component used for the first step is the FwL component, and the tip of the component is positioned such that the part of the tongue just behind the tip is pressed downward.

Fig. 17D represents the position of the top of the limiting mechanism component for the second stage of treatment. As shown, the component used for the second step is the FwS component, and the top of the component is positioned such that the portion of the middle of the tongue (approximately adjacent to the first molar) is pressed downward.

And finally, Fig. 18A-D show an exemplary treatment plan for treating a tongue condition associated with persistent atypical swallowing, in accordance with one or more embodiments. Fig. 18A is an enlarged schematic representation of the shape of the tongue in an abnormal position associated with the present dysfunction. In this state, as shown in FIG. 18A, the patient's tongue is in an abnormally high up position, but the palate is normal. This change in tongue morphology is thought to be caused by persistent atypical swallowing, in which the tongue is in an incorrect position when swallowing. Fig. 18B is a layout diagram of the pinnacle of the limiting mechanism component for each of the two stages of treating the tongue condition shown in FIG. 18A. As in the previous examples of treatment, the duration of each stage of treatment may vary depending on each individual patient and the individual morphology of the patient's oral cavity, as well as other factors described below.

Fig. 18C represents the position of the top of the limiter component relative to the tongue for the first stage of treatment. As shown, the component used for the first step is the FwS component, and the apex of the component is positioned immediately anterior to the first molar such that the middle part of the tongue is pressed downward.

Fig. 18D represents the position of the top of the limiter component for the second stage of treatment. As shown, the component used for the second step is also a FwS component, and the apex of the component is adjacent to the first molar such that the portion of the middle of the tongue (approximately adjacent to the first and second molars) is pressed downward.

duration of treatment.

The duration and regimen of treatment significantly depend on the morphology of the patient's oral cavity and the severity of the disorder. Other factors such as patient age, general health, innate responsiveness to treatment, and treatment tolerance also play a role. In general, treatment begins with the patient wearing the device for several hours in a row during the day and night for 3-4 weeks, after which they wear the device only during sleep. The duration of treatment is typically from about 3 to about 10 months. If both the forward and reverse components are to be used, they should be used serially for at least approximately 3 weeks each until the last stage is reached, which will last for the remainder of the treatment period. Tongue pressure adjustment (angle and sagittal length of the tip of the component, the latter achieved by changing to longer or shorter components and by varying its vertical angle with respect to the occlusal plane, if necessary) and/or the basal plane of the component given by the wire ends , can be performed periodically. If necessary, the treatment can be repeated after a break.

Dental device kit

As seen from the examples above, a tongue restraint program may, in at least one exemplary embodiment, consist of a plurality of different dental devices used sequentially according to a specific plan for each individual patient. Accordingly, a plurality of devices may be included in an individual kit or assembly for use by a patient as part of an individual tongue restriction program or plan. In addition, it should be noted that other individual programs may require only one dental device to achieve the desired results for a particular patient, so a set of multiple dental devices is not required.

It should be understood that the above embodiments and examples are illustrative of the dental device of the present application and are not limiting. Specific embodiments have been described above, however, additional embodiments, modifications, or variations within the scope of the claims set forth below, including equivalents, may be known to those skilled in the art.

Claims (37)

1. Dental device for limiting the movement of the back region of the patient's tongue, allowing the anterior region and the lateral edges of the tongue to perform the movements necessary for speech and swallowing, and the dental device contains: an attachment mechanism for attaching the dental device to the teeth in the patient's oral cavity, and the attachment mechanism includes an open circular tape having: a first surface located on the buccal side of the patient's dental arch; a pair of left and right second surfaces, each of the second surfaces opposite the first surface and adapted to be placed together with at least one back, respectively left or right, tooth on the lingual side of the above at least one tooth; said second surfaces are adapted to extend along the lingual side of a limited number of back teeth of the patient; and a connecting element connecting the first surface and the second surface; and a releasably restrictive mechanism attached to the attachment mechanism and comprising a component stretched between a pair of second surfaces, the component being backward oriented and configured to be positioned in or at an angle to the occlusal plane of the person wearing the device to restrict movement of the posterior region of the tongue and thereby narrow the range of motion of the tongue to a more limited three-dimensional space than in the absence of the device, while allowing at least the anterior region and the lateral edges of the tongue to carry out the movements necessary for speech and swallowing; at the same time, the fastening mechanism is made with the possibility of fixation on the dental arch of the patient with the possibility of subsequent removal of the device from the dental arch. 2. A dental device, comprising: a fastening mechanism for fixing the dental device on the teeth in the patient's oral cavity, while the fastening mechanism includes an open circular tape having: a first surface on the buccal side of the patient's dental arch; a pair of left and right second surfaces, each of the second surfaces opposite the first surface and adapted to be placed together with at least one posterior, respectively left or right, tooth on the lingual side of said at least one tooth; moreover, these second surfaces are made with the possibility of passing along the lingual side of a limited number of back teeth of the patient; and a connecting element connecting the first surface and the second surface; and a releasably restrictive mechanism attached to the fastening mechanism and comprising a component stretched between a pair of second surfaces and centrally located relative to the second surfaces and the front of the tape to be located at the Central part of the tongue, and the component is oriented in a forward direction and configured to be located in occlusal plane of the wearer, or at an angle to it, in each case to limit the movements of the central region of the tongue and thereby narrow the range of motion of the tongue to a limited three-dimensional space, while allowing the movements of the posterior region, tip and lateral edges of the tongue necessary for speech and swallowing; while the attachment mechanism is adapted for fixation on the patient's dental arch with the possibility of subsequent removal of the device from the dental arch. 3. The dental device of claim. 1 or 2, in which the limiting mechanism or attachment mechanism includes an adjustment mechanism to regulate: (i) the angle of the component relative to the occlusal plane of the patient when wearing the device and thereby to control the degree of restriction of movement of the tongue; or (ii) the position of the component along the longitudinal axis of the device and thereby to control the area of the tongue where the constraint will apply; or (iii) both the specified angle and the specified position. 4. Dental device according to claim 3, in which: the component contains the first and second ends; the limiting mechanism is attached to the fixing mechanism by means of an adjustment mechanism which includes a fixing mechanism, and the fixing mechanism comprises a combination of a nut and a screw or a nut and a bolt, wherein each end of the component is slidably mounted and attached to the fixing mechanism longitudinally adjustable forward or backward manner; moreover, the component is made with the possibility of adjustment relative to the occlusal plane by changing the angle of the ends of the component or by removing the component and replacing it with another component with a different predetermined angle. 5. The dental device of claim 3, wherein the restraint mechanism has one end that is connected to the left second surface and a second end that is connected to the right second surface. 6. A dental device according to claim 1 or 2, wherein the component is stretched between the right and left second surfaces at the back of the tape in close proximity to the pair of second surfaces. 7. A dental device according to claim 1 or 2, wherein the open circular band includes a resinous material in contact with the dental arch while the device is being worn. 8. Dental device according to claim 7, wherein the first surface of the attachment mechanism conforms to the contour and corresponds to the gum line from the buccal surface of the patient's upper dental arch. 9. The dental device of claim. 8, wherein the first surface of the attachment mechanism covers at least most of the buccal surface of the dental arch from the gum line and down, but does not cover the bite surface of the teeth of the said arch. 10. A dental device according to claim 1 or 2, wherein said limited number of back teeth is between one and three. 11. The dental device of claim 1 or 2, wherein the restraint mechanism is attached to the attachment mechanism by a locking mechanism. 12. A dental device according to claim 1 or 2, wherein the open circular band also includes a wing attached to the lingual side of the second surface, the wing comprising a measuring device optionally integrated in the wing. 13. The dental device of claim 12, wherein the measurement device is a temperature, pH, or sound sensor. 14. The dental device of claim 12, wherein the wing further comprises a resinous material and/or the measurement device is embedded in the resinous material and positioned so as not to touch the patient's palate or teeth when the device is being worn by the patient. 15. The dental device of claim. 10, in which the component has a C-shape, and the back of the component is placed transversely relative to the longitudinal axis of the device and is responsible for limiting movements of the tongue, and in which the limiting mechanism has first and second end parts for attaching the limiting mechanism to the attachment mechanism of the corresponding second surface by means of the locking mechanism. 16. Dental device according to paragraphs. 1, 2, or 15, in which the component is at an angle to the plane defined by the two ends of the limiting mechanism. 17. Dental device according to paragraphs. 1, 2 or 11, in which the limiting mechanism includes a wire, optionally containing a central section coated with a polymeric material. 18. Dental device according to claim 1 or 2, which further includes an arcuate support element to enhance the rigidity or strength of the device, and the arcuate element encloses the second surfaces and is located ascending, following the contour of the palate and not touching the teeth or palate of the patient when wearing the device. 19. The dental device of claim. 1, wherein the component is inclined at an angle relative to a plane defined by the ends of the limiting mechanism, and the angle is from +15° to -15° when the device is worn by the patient. 20. The dental device of claim 3, wherein the adjustment mechanism includes a pair of oblique or vertical loops or stops, each loop being located proximate the end of the restriction mechanism and the loops being formed by a wire to adjust the angle of the component. 21. The dental device of claim 3, wherein the restraint mechanism includes a wire and the adjustment mechanism includes a pair of horizontal loops of wire, the loops being formed by the wire and each loop located near the end of the restraint mechanism for eventual lateral expansion of the component. 22. The dental device of claim 1 or 2, wherein the component comprises a wire with a central brace for flexibility and possible lateral expansion of the component. 23. The dental device of claim. 11 wherein the locking mechanism is incorporated into one of the second surfaces of the attachment mechanism to lock the locking mechanism to the attachment mechanism. 24. The dental device of claim 23, wherein the locking mechanism further comprises (i) a sheath including a chute, the sheath slidably accommodating the end of the restrictive mechanism, and (ii) a tension member for locking the end of the restraint mechanism into the chute. 25. The dental device of claim 23, wherein the locking member includes a combination of a nut and screw or a nut and bolt, each end of the restraining mechanism being slidably mounted and locked by the locking mechanism in an adjustable manner. 26. The dental device of claim 24 wherein the restraint mechanism comprises a pair of vertical or inclined wire loops and the locking mechanism comprises a rubber band for wrapping the sheath and loop and thus securing the end of the restraint mechanism to the attachment mechanism. 27. The dental device of claim. 24, wherein the locking mechanism provides longitudinal adjustment of the position of the component forward or backward. 28. The dental device according to claim 1 or 2, wherein the limiting mechanism is slidably mounted in the adjustment mechanism by means of the locking mechanism to allow adjustment of the position of the component along the longitudinal axis of the device. 29. The dental device of claim 17, wherein the wire includes a center section coated with a polymeric material. 30. The dental device of claim 1 or 2, wherein a slidable limiting mechanism is installed in the adjustment mechanism to allow adjustment of the position of the component along the longitudinal axis of the device. 31. The dental device of claim 2, wherein the restraint mechanism component is angled relative to the patient's occlusal plane when the device is being worn or a plane defined by the ends of the restraint mechanism, wherein the angle is between 0 and 30° when the device is worn by the patient. 32. The dental device of claim 1 or 2, wherein the component further includes a wire with a central brace for flexibility and possible lateral expansion of the component. 33. Dental device according to claim. 1 or 2, in which the adjustment mechanism does not include hinges. 34. The dental device of claim. 11, wherein the locking mechanism includes at least one tab attached to or embedded in a corresponding second surface of the locking mechanism to lock the locking mechanism to the locking mechanism. 35. The dental device of claim. 11, in which the locking element provides longitudinal adjustment of the component back and forth. 36. Assembly for limiting the movement of the tongue when used in a dental device to limit the movement of the back region of the patient's tongue, and the assembly contains a limiting mechanism, an adjustment mechanism and a locking mechanism, while: the limiting mechanism contains a component configured to be placed between a pair of second surfaces of the attachment mechanism device located along the lingual side of a limited number of back teeth of the patient, and the component is oriented in the opposite direction relative to the patient's oral cavity and configured to be located in the occlusal plane of the patient or at an angle to it, to limit the movement of the back of the tongue and thereby narrow the range moving the tongue to a more limited three-dimensional space than without the device, while allowing movements of at least the anterior region and lateral edges of the tongue necessary for speech and swallowing; the limiting mechanism has a pair of ends, each slidably attached to the adjustment mechanism by means of a locking mechanism, which allows adjustment of the position of the component in the longitudinal direction, each end is configured at an angle to the component, and the two ends define a plane; the locking mechanism is adapted to be attached to the fastening mechanism and includes a tensioning mechanism for fixing the ends of the limiting mechanism in a predetermined position. 37. Assembly for limiting the movement of the tongue when used in a dental device to limit the movement of the back region of the patient's tongue, and the assembly includes a limiting mechanism, an adjustment mechanism and a locking mechanism, while: the limiting mechanism includes a component configured to be located between a pair of second surfaces of the attachment mechanism device located along the lingual side of a limited number of back teeth of the patient, and the component is oriented in a direct direction relative to the patient's oral cavity and configured to be located in the occlusal plane of the patient or at an angle to it, to limit the movement of the back of the tongue and thereby narrow the range moving the tongue to a more limited three-dimensional space than without the device, while allowing movements of at least the anterior region and lateral edges of the tongue necessary for speech and swallowing; the limiting mechanism has a pair of ends, each slidably attached to the adjustment mechanism by means of a locking mechanism, which allows adjustment of the position of the component in the longitudinal direction, each end is configured at an angle to the component, and the two ends define a plane; the locking mechanism is adapted to be attached to the locking mechanism and includes a tensioning mechanism for securing the end portions of the limiting mechanism in a predetermined position.

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