WO2017214740A1

WO2017214740A1 - Stimulator that allows sleep bruxism to be treated using electrical signals

Info

Publication number: WO2017214740A1
Application number: PCT/CL2016/000030
Authority: WO
Inventors: Pablo Esteban Aqueveque Navarro; Roberto Sebastián LÓPEZ VALENZUELA
Original assignee: Universidad de Concepción
Priority date: 2016-06-14
Filing date: 2016-06-16
Publication date: 2017-12-21
Also published as: CL2016001487A1

Abstract

The invention relates to a stimulator system that allows sleep bruxism to be treated using electrical signals, the system having a built-in electronic intrabuccal neurostimulator and a base station. According to the invention, the intrabuccal neurostimulator comprises: a system for receiving energy; a system for storing energy; a microprocessor for controlling stimulation according to pre-set parameters; a stimulus generator; electrodes with low corrosion levels; and packaging for protecting the stimulator. The base station comprises: a power source; a microprocessor for controlling the energy delivered wirelessly to the intrabuccal neurostimulator; a user interface; a wireless data communication circuit for communicating with the intrabuccal neurostimulator; and a wireless energy transmission system.

Description

A STIMULATOR THAT ALLOWS TO TREAT THE DREAM BRUXISM FROM ELECTRICAL SIGNS. Technical Sector

The technology is oriented to the area of health, more specifically, it corresponds to a stimulating system that allows the treatment of sleep bruxism from electrical signals.

Previous Technique

Sleep bruxism is a very common dental and health problem in the population, both nationally and internationally. This disorder occurs most frequently in the young and young adult population.

Bruxism is a repetitive mandibular muscle activity that is characterized by clenching and grinding of the teeth, and / or by bracing or thrusting of the jaw Lobbezoo et al., (2008). In this way, bruxism can be divided into two types according to its circadian manifestation: vigil bruxism (BV) that occurs while the person is awake, and sleep bruxism (BS) that occurs while the person is sleeping. The biggest problem for the BS is that when the person is sleeping, he does not have the possibility of realizing that he is performing bruxism, which makes it more difficult to stop performing this activity. Additionally, it produces irreversible damage to dental structures, especially in the periodontium, even reaching joint surfaces and muscular pain, which alters the masticatory function (Carlsson et al., 1999). The short-term effects lead to muscle pain and fatigue of the muscles involved in chewing, especially the masseter and the anterior temporal, poor quality of sleep, headaches and neck muscle aches. In the long term it causes damage and dysfunction of the temporo-mandibular joint, significant damage to the structure of the periodontium, dental wear that can lead to fracture of the teeth, and in some people this can cause gum recession (Wool, 2004). On the other hand, the relationship between bruxism and changes in the stages of sleep has been evaluated, since many of the episodes of bruxism lead to a change in the phase of sleep usually towards awakening or a lighter dream in which it was the person (Bader and Lavigne, 2000).

The prevalence of bruxism varies with respect to the age range considered. As reported by Manfredini et al., 2013, the prevalence of bruxism is between 8 - 31%, with a decrease in this activity with age.

Over time, various types of treatments have been implemented to reduce the adverse effects generated by BS. The treatment that mostly

i used is the plane of relaxation through the interoclusal orthopedic device, also called occlusal splint. It is a device that can be fixed or removable, and is used only as a temporary solution that helps to deprogram the muscle for an occlusion adjustment, avoid direct contact between the teeth and decrease the noise that occurs when grinding them. Some studies have shown that the use of occlusal splints has produced some decrease, but no effect or even an increase in muscle activity.

Another interocclusal device is the tension suppression system (NTI), which is a tension suppression plate of the trigeminal nociceptive system that is usually positioned in the upper front teeth. Studies reported by Baad-Hansen et al., 2007, indicated that it turns out to be more effective than the splint in terms of decreasing contractile activity. Both devices are able to reduce the EMG activity of the muscles, but they do not produce relevant changes for the pain caused by this disorder. On the other hand, the use of the NTI generates discomfort and pain, because all the force of tightening in the front teeth is generated while the rest of the teeth are not touched. Electromyography (EMG) is another method used to detect BS. It allows recording the electrical activity generated by the contraction of the muscles involved in chewing, using surface electrodes connected to an electromyography equipment. However, other types of movements and activities that people perform when sleeping can interfere with the correct determination of bruxism events. There are other devices that use audible signals through hearing aids to interrupt sleep bruxism events, which, although they cause a significant decrease in muscle activity when the subject is performing BS, these effects have been reported to be temporary when has followed up after the use of the device (Lobbezoo et al., 2008).

Takeuchi et al., 2001, developed a device composed of a thin piezoelectric film inside a splint, to measure the pressure exerted between the teeth, which was sensitive to deformation. It was inserted under the occlusal surface and a portable analog signal recording device was used to measure the EMG signals of the masseter muscle and the device. They concluded that the use of the piezoelectric film has limitations, since it failed to faithfully display the sustained force values. However, it apparently reproduced bruxist behaviors with durations similar to those detected with masseter EMG.

On the other hand, biofeedback treatments have been developed with electrical stimulation in different areas of the face, to stop the activity of bruxism by stimulating the muscles involved in chewing, or in the nerves. Among the devices that use this technology is the one developed by Jadidi et al., (2007), commercially referred to as Grindcare®. This apparatus comprises a recording electrode and a stimulation that is positioned in the anterior temporal muscle, which is controlled in a way wireless To achieve bruxism detection, they used a signal recognition algorithm. The results indicated that the number of EMG episodes / hour decreased in comparison to the baseline EMG activity and the session without biofeedback. The study also suggests that there were no significant sleep disturbances. These results provide good evidence of the use of electrical stimulation to produce a decrease in the contraction of the muscles that close the jaw. Subsequent studies have been carried out on this device, such as to determine if the use of Grindcare® can control or reduce the level of tightening activity in bruxists, finding that the majority of patients reported a decrease in bruxism, but should be taken considering that these results were based on a patient self-report, measured on visual analog scales. Regarding the use of implantable electronic stimulatory intrabuccal devices, it has been determined that one of the complications they present is its difficult and uncomfortable use when sleeping. Another important point in the case of devices that use EMG to measure the level of muscle contraction, such as the Grindcare® device, is the discomfort of having to place surface electrodes on the face and forehead every day. Therefore, it is necessary to develop new ways to implement the equipment, so as not to generate discomfort and discomfort in the patient.

Some patents related to treating bruxism are detailed below:

1. - US Patent 4,838,283 (Lee, Jr.), called: Anti-bruxism device. An apparatus and a method for the control and prevention of bruxism are protected. Said apparatus comprises: means for generating a sound adapted to be mounted in the lower jaw of a patient or in the bone structure connected to the upper jaw for the generation of a sound; means for receiving the sound and for producing a voltage signal in response; alarm means to alert the patient when bruxism occurs; (d) electrical control means to activate said alarm; and (e) means for generating adjustable electrical signals to transmit a signal to said sound generating means.

2. - US Patent 4,934,378 (Perry, Jr.), called: Bruxism method and apparatus using electrical signáis. A method and an apparatus for the detection and biofeedback of the subconscious and the clenching of teeth when sleeping of a patient is protected. The method comprises: inserting an elongated transducer into the ear canal; use the electrodes to detect electrical signals at the microvolt level in the ear canal wall; amplifying said electrical signals using amplifying means; electronically distinguish said electrical activity signals; and use the signals to warn the patient that he is clenching his teeth.

3. - US Patent 6,270,466 B1 (Weinstein et al.) Named: Bruxism biofeedback apparatus and method including acoustic transducer coupled closely to user's head bones. A method and an apparatus are protected for the treatment of bruxism through a biofeedback. The apparatus is composed of: electrically conductive electrodes; means for pressing said electrodes against the external part of the user's skin; amplification / sensor means for determining the voltage difference between at least 2 electrodes and selectively amplifying the electrical signals generated by bruxism muscles; a detector that generates an eventual signal of bruxism; and acoustic output means to mechanically couple a vibrational band audio output signal. 4.- Patent application WO 03/059160 A1 (Yerushalmy, Israel), called Apparatus for treating bruxism. An apparatus for treating bruxism is protected, which includes a biosensor adapted to detect a phenomenon associated with a bruxism event and a relaxation stimulator in communication with a biosensor, which is adapted to provide a relaxation stimulus to relax at least a muscle and a nerve affected by bruxism.

5. - Patent application WO 2004/087258 A1 (Jadidi), called: Method of and apparatus for monitoring of muscle activity. A device and a method for monitoring muscle activity are protected. Where the apparatus comprises: means for providing indicative signals of muscle activity; means for processing said signals in order to detect a particular unwanted activity; means to provide a biofeedback signal. The device can be used for the detection and prevention of an unwanted activity such as bruxism, harmful or unwanted movements, among others.

6. - Patent application WO 2009/036769 A3 (Jadidi et al.) Named: Electrode assemblies and bruxism monitoring apparatus. An apparatus for monitoring muscle activity relative to bruxism is protected, which comprises: a set of electrodes to provide signals indicating muscle activity; means for processing said signals in order to detect bruxism; and means to provide feedback signals in response to bruxism detection.

7. - Patent of invention ES 2 313 843 (Lafont et al.) Called: System for the detection and treatment of bruxism and other occlusal pathologies. A system with intrabuccal detection of bruxist activity and other occlusal pathologies is protected, as well as transmission to portable electronic elements. The extra-oral performance is carried out by means of elements capable of emitting acoustic, luminous or vibratory signals, at choice, being able to be of variable or progressive intensity, so that they alert the patient of their unwanted behavior. Intrabuccal action stops bruxist activity by supplying drugs, bitter substances and / or application of electrical or vibratory stimuli. 8.- Patent application WO 2009/036770 A2 (Jadidi & Claus) called: Electrode connection monitoring. The technology protects an apparatus and a method for measuring muscle activity, in particular in relation to bruxism Provides electrical stimulation in response to measured muscle activity, through electrodes applied to the skin of an individual.

9.- US patent application 2012/0271190 A1 (Mortenser et al.) Named: Apparatus for electrical stimulation, in particular for bruxism. The technology corresponds to a method and an apparatus to prevent, diagnose, monitor and / or treat bruxism, as well as diseases related to an individual. The apparatus comprises: applying stimulation signals to provide relaxation of at least the jaw and / or facial muscles; apply said stimulation signals with a predefined setting; and apply said signals independent of the activity of the muscle (s).

Disclosure of the Invention The present technology corresponds to an implantable stimulator device that has an electronic neurostimulator embedded in the front part, which allows treating the bruxism of sleep from electrical stimulation. This device generates a very low intensity impulse, imperceptible by the person and injected into the sensory nerves, and where this signal goes to the brain, that is, it is an inhibitory and relaxing action of the muscles, where there is no pain and discomfort in the patient Stimulation is performed with a predefined pattern for each person without the need to measure interdental pressure or electromyography, and that stimulates at intervals during sleep hours. One form of implementation may include the measurement of EMG internally in the mouth with intrabuccal electrodes to detect the activation of the masticatory muscles, where in that case the detection of the action of bruxism is performed indirectly by means of a threshold of EMG (strength) and time of realization of force. The implantable device advantageously allows to stimulate and produce the relaxation reflex of the masticatory muscles when the patient is asleep and does bruxism. It is located in the jaw, under the front teeth with the neurostimulator electrodes over the entrance area of the chondonian branch of the trigeminal nerve. It allows to increase the comfort of the use of the device compared to devices that measure EMG and use surface stimulation, this because the use of cables and electrodes with glue is eliminated. It would only be limited to a small surgery, where the specialist makes a small incision in the area to place the implant. The entire device can be rigid or flexible. The materials used to manufacture the structure are preferred, but not exclusively, thermo-curing acrylic or medical grade silicone for the rigid or flexible version, respectively. In Figure 1 it is shown in (a) the position of the neurostimulator in the intrabuccal chin area, in addition the exit of the chondon nerve branch of the trigeminal nerve (b) is observed, which is where the stimulator must apply the electronic pulses. Due to the existence of saliva and body temperature, good packaging is imperative to protect the electronic circuits that make up the neurostimulator. This implantable device has energy autonomy to operate for at least 8 hours, where the batteries are charged wirelessly. This allows to ensure a sufficient load for a correct operation during the hours in which the patient is sleeping.

The implantable device uses metallic electrodes of the surgical or platinum steel type, which make contact with the tissue through the conductive properties provided by the saliva that is present in that area of the mouth. The impedance between the electrodes is composed of the impedance of the saliva between the electrodes and the impedance of the tissue to be stimulated. The electrodes preferably have a circular shape, typically 5 mm in diameter, but larger dimensions not exceeding 20 mm are not excluded by the restricted space of the mouth area. Optionally, the electrodes can be made in different ways such as square, rectangular or oval.

The neurostimulator system is composed of 2 main elements: a base station and an intrabuccal neurostimulator. The base station is an electronic device whose functionality is to wirelessly charge the intrabuccal neurostimulator with energy and configure its stimulation parameters. This device can be energized by the available mains (110 or 220 V in networks with 50 or 60 Hz). The base station is located outside the person, and has the shape of a rectangular or circular platform where the intrabuccal neurostimulator can be positioned. This device works during the day (charging energy), when the person is not using the intrabuccal neurostimulator.

The base station comprises at least the following elements:

• a power source that provides power to the system and connects to the available power grid;

• a microprocessor to control the energy delivered wirelessly to the intrabuccal neurostimulator device;

• a user interface, which is composed of push-button switches and LED indicators. This user interface can be replaced by a user interface on a portable device such as a mobile smart phone or a Tablet;

• a wireless data communication circuit to communicate with the intrabuccal neurostimulator; Y

• a wireless energy transmission system, which delivers energy to the intra-oral neurostimulator to charge the internal batteries. This system can be an inductive charging system.

A diagram with the components of the base station is shown in Figure 2, where (I) corresponds to the power source, (II) the user interface, (III) to the micro-controller, (IV) to the communication, (V) to the transmission of energy, and (VI) the neurostimulator.

The user interface can be implemented in an interface where it fits and controls each of the parameters that define the shape of the electrical pulses that make up the electrical stimulation. This interface is implemented on the screen of an external device such as a mobile smart phone or a Tablet, showing in a friendly way and easy to adjust the parameters of the stimulation system. The use of this type of equipment is preferred due to its low cost, its easy update and the graphic power to implement the interface. Thus, the user interface can be eliminated from the base station, allowing to reduce its size, weight and energy consumption, as well as reduce its price. This has allowed to generate a small, reliable, efficient, low cost and highly portable device.

The parameters that can be adjusted in this user interface are: amplitude of the stimulation current, which corresponds to the level of current that is entered into the nerve and is measured in microamps or milliamps;

stimulation frequency, which is related to the speed at which the pulses are emitted and directly affects the quality of relaxation achieved by stimulating;

pulse width, which corresponds to the time in which a rectangular pulse of an electric nature remains in a non-zero state, generating the action potential in the stimulated nerve;

stimulation time, time in which a train of stimulation pulses is carried out constantly and that allows to produce the relaxation actions. This time can be adjusted from 1 microsecond to 20 seconds; Y

Stimulation interval, this parameter sets the time interval between each pulse train that has the stimulation time. This parameter is adjusted for each patient and can be between 1 second and 20 minutes.

On the other hand, the intrabuccal neurostimulator is an electronic device whose function is to produce electronic stimulation inside the patient's mouth according to pre-configured parameters. This device is energized by an energy storage element such as a battery or a supercapacitor that is embedded in the same encapsulation of the neurostimulator. This device has an ergonomic design to be positioned in the front area of the jaw, inside the mouth and under the front teeth. Preferably, it has an oval or rectangular shape, and works inside the mouth during the night when the person is sleeping, generating imperceptible electronic pulses. These pulses produce the stimulation of the chin sensory nerve and the relaxation reaction of the musculature associated with chewing. The intrabuccal neurostimulator is composed of at least the following elements: an energy reception system, which by means of an inductive link receives energy wirelessly from the base station. The device receives power during the day when the device is not in use; • an energy storage system (rechargeable micro-batteries or super-capacitors), to energize the device and is sized to energize the neurostimulator for at least 8 hours. This element considers the electronic circuits to regulate the voltage that energizes the electronic neurostimulator;

• a microprocessor for stimulation control according to the pre-configured parameters;

• a stimulus generator, composed of a low magnitude electric current source to produce the stimulation according to the pre-configured parameters. These current stimuli are generated in the form of a pulse and are applied to the electrodes;

• electrodes with low levels of corrosion, which are constructed using surgical steel (or AISI 316L or higher) or platinum. For ease of construction, circular electrodes are preferred, however, other geometric shapes of electrodes such as square, rectangular or oval can be used; Y

• packaging and protection, encapsulated with implant levels, and can be implemented using dental acrylic as a thermosetting acrylic, or through biocompatible silicone. This allows the neurostimulator to be implemented rigidly or flexibly. This packaging is required to ensure that the electronic circuits that make up the stimulator are not affected by saliva or high humidity levels. The entry of saliva or high humidity can cause corrosion and cause the stimulator circuit not to work properly.

Figure 3 shows a block diagram with the main elements that make up the intrabuccal neurostimulator, where (VII) corresponds to the reception of energy, (VIII) to the storage of energy, (IX) to the communication, (X) to microcontroller, (XI) to the stimulus generator, (XII) to the electrodes, (XIII) to the hermetic encapsulation.

Application example Example 1. Application of the implantable stimulator device in patients suffering from sleep bruxism (BS).

The stimulator device was evaluated to corroborate that the method of electrical stimulation on inhibitory nerve afferences generated a decrease in the activity of the muscles involved in chewing. Preliminary tests were performed on patients affected by BS using the superficial stimulator in the area where the chin nerve was branched. To measure the changes in the level of contraction of the masticatory muscles, the EMG activity of the anterior temporal muscle (main muscle involved in mandibular elevation) was measured with superficial electromyography. The stimulation principle is the same as that applied for stimulation with an implant. inserted under the inner part of the lower lip, in the branching area of the chin branch. The main difference is the decrease in electrode-skin impedance when the device is implanted. However, the waveform, frequency and duration of the stimulus are the same to generate the response of muscle contraction inhibition.

To determine the stimulation parameters, preliminary tests were performed on 5 bruxist sleep patients. Patients were asked to clench their teeth to maximum voluntary contraction for 4 seconds. Then stimulation was used from a square wave pulse train for the last 2 seconds of tightening. The EMG activity of the anterior temporal and mastery muscles was measured. Different stimulus amplitudes were tested, from 10 to 100 μΑ, frequencies between 300-500 Hz and a pulse width of 50%. With respect to the frequency, a decrease in EMG activity could be observed throughout the chosen range. When combining the different amplitude values with the pulse train frequencies, it was noted that the greatest effect of decrease in EMG activity was when it was stimulated at 300 Hz. The results indicated that at 100 μΑ patients began to feel stimulation In some cases pain occurred, and EMG activity was altered. Under that amplitude, the stimulus was imperceptible to the patients. The values that achieved the best results were between 40 - 50 μΑ.

Based on these results, the tests consisted of measuring the level of decrease in muscle contraction when applying electrical stimulation to patients with bruxism, when they perform BS while they are sleeping. For this, a stimulator team was used to record, identify the events of bruxism and apply electrical stimulation to reduce the activity of the masticatory muscles, which leads to reducing the intensity of the BS. The tests were carried out for 12 continuous nights, where patients were asked to take the device home to use while they slept. The tests were divided into 4 sections of 3 nights each. The first section was only reference measurement (EMG measurement only), the second section was with EMG measurement and electrical stimulation application when the equipment detected bruxist activity, the third section was only EMG measurement to observe the activity trend Bruxist to stop stimulating for a few days and, finally, in the fourth section electrical stimulation was reapplied. Figure 4 shows a scheme of the test implemented, where (A) corresponds to the reference EMG for nights 1 to 3; (B) to stimulation during nights 4 to 6; (C) to the EMG for nights 7 to 9; and (D) to the stimulation of nights 10 to 12.

The stimulator electrodes were positioned in the chin area, and the measurement electrodes were positioned in the anterior temporal muscle area. To identify the best position for the measuring electrodes, patients had to palpate the temporal muscle and detect the anterior area of the muscle, where the muscle contracts with greater intensity when the teeth are clenched. After that, the electrodes should be placed 1 cm apart following the orientation of the muscle fiber. In this way, when patients were ready to go to sleep, measuring and stimulation electrodes should be placed. Then, they had to lie on their bed and put on the device, which consisted of equipment that had an EMG signal conditioning circuit, a microcontroller, provided with an algorithm for the detection of the BS and the stimulator control, and the stimulator.

To analyze the electrical muscle activity, the integrated EMG signal (EMGInt), which is directly related to the bite force, was calculated. Thus, to define the decrease in contractile activity of the muscles, the area under the curve of the EMGInt signal was evaluated. Upon detection of a bruxism event, the area under the signal curve was calculated the moment before stimulating and compared with the moment after electrically stimulating. That was how it was possible to determine how much the muscular activity decreased at the time of electrically stimulating.

The results varied among patients, but all showed a clear decrease in the average number of BS events during the night, which can be seen in Figure 5. In addition, an average decrease in the area under the curve of a 43 was noted, 55% after applying the electrical stimulus.

Finally, from the tests carried out satisfactory results were obtained, which indicates that the biofeedback method by electrical stimulation on inhibitory nerve afferences, generated a decrease in the contractile activity of the muscles involved in chewing in patients with sleep bruxism. This is applicable in the case of the implantable device, since the physiological principle is the same, the stimulation parameters are the same, except for the amplitude of the stimulus and the response generated is the same.

Claims

1. - A stimulator system that allows treating sleep bruxism from electrical signals CHARACTERIZED because it has an embedded electronic intraoral neurostimulator and also has a base station; where the intraoral neurostimulator comprises: an energy reception system, an energy storage system, a microprocessor to control the stimulation according to pre-configured parameters, a stimulus generator, electrodes with low levels of corrosion, and packaging and stimulator protection; and where the base station comprises: a power source, a microprocessor to control the energy that is delivered wirelessly to the intraoral neurostimulator device, a user interface, a wireless data communication circuit to communicate with the intraoral neurostimulator and a system wireless power transmission.

2. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because it stimulates at intervals during sleep hours with a predefined stimulation pattern for each person.

3. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the stimulation originates when an EMG signal is measured internally in the mouth with intraoral electrodes to detect the activation of the masticatory muscles, where Detection of the action of bruxism is carried out indirectly through force threshold and force realization time.

4. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the base station wirelessly charges the intraoral neurostimulator with energy and configures its stimulation parameters.

5. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the base station is located outside the person, and has the shape of a rectangular or circular platform where the intraoral neurostimulator is positioned.

6. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the power source provides energy to the neurostimulator system and is connected to the available energization network.

7. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the user interface is composed of push-button switches and LED light indicators or a portable device such as a smart mobile phone or a tablet. .

8. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the intraoral neurostimulator is energized by an energy accumulator of the battery or supercapacitor type, which is embedded in the same encapsulation of the neurostimulator.

9. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the energy reception system through an inductive link receives energy wirelessly from the base station, when the stimulator is not in use. .

10. - A stimulator that allows sleep bruxism to be treated from electrical signals according to claim 1, CHARACTERIZED because the stimulus generator comprises a source of low magnitude electrical current to produce stimulation according to pre-configured parameters.

11. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the packaging and protection of the stimulator is carried out by means of an encapsulation with implant levels that is made using acrylic for dental use such as acrylic. heat curing, or using biocompatible silicone.

12. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the stimulation electrodes are of the surgical steel or platinum type, and have a circular, square, oval or rectangular shape.

13. - A stimulator that allows treating sleep bruxism from electrical signals according to claims 1 and 3, CHARACTERIZED because the EMG measurement electrodes are of the surgical steel or platinum type, and have a circular, square, oval or rectangular shape. .

14. - A stimulator that allows treating sleep bruxism from electrical signals according to claims 1, 12 and 13, CHARACTERIZED because the electrodes, when circular in shape, have a diameter of at least 5 mm.

15. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the stimulator is installed in the jaw, in the chin area, intraoral, under the front teeth with the electrodes of the neurostimulator on the area of entry of the mental branch of the trigeminal nerve.

16. - A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the stimulator is rigid and is made of heat-cured acrylic.

17.- A stimulator that allows treating sleep bruxism from electrical signals according to claim 1, CHARACTERIZED because the stimulator is flexible and is made of medical grade silicone.

18.- A stimulator that allows treating sleep bruxism from electrical signals according to claim, CHARACTERIZED because the stimulator has energy autonomy to function for at least 8 hours, where the batteries are charged wirelessly.