WO2022146294A1

WO2022146294A1 - System and method where auricular vagus nerve is stimulated by intermittent direct current for treatment of diseases and disorders

Info

Publication number: WO2022146294A1
Application number: PCT/TR2021/050576
Authority: WO
Inventors: Ali Veysel OZDEN; Ali Can ERK
Original assignee: Vagustim Saglik Teknolojileri Anonim Sirketi
Priority date: 2020-12-30
Filing date: 2021-06-14
Publication date: 2022-07-07
Also published as: TR202022374A1

Abstract

The invention relates to a method, a system and a device for treating the diseases and/or disorders by way of stimulation of the auricular vagus nerve by intermittent direct current. More particularly, the invention relates to a method, a system and a device wherein the stimulation may be performed in a controlled manner by providing intermittent direct current to at least one of, preferably both, vagus nerves in the ears.

Description

SYSTEM AND METHOD WHERE AURICULAR VAGUS NERVE IS STIMULATED BY INTERMITTENT DIRECT CURRENT FOR TREATMENT OF DISEASES AND DISORDERS

Subject of the Invention

The invention relates to a system, a device and a method for treating the diseases and/or disorders by way of stimulation of the auricular vagus nerve by intermittent direct current.

State of the Art

The autonomic nervous system is a system controlling all of the vital functions of the body. In other words, all of the functions of our organs that are not able to be controlled by ourselves are managed by the autonomic nervous system. The activity of the autonomic nervous system varies during the daily life, serving to enable our body to accommodate the changes in the internal and external environment. The impairments in the variable activity of the autonomic nervous system lead to the impairment in the body's ability to adapt to the variables in the internal and external environment, resulting in the emergence of the autonomic dysfunction and the associated diseases. Activation of the nerves via stimulation is employed for the treatment of the resulting disorders and diseases.

While the activities like sports, yoga, breathing exercises and massage are used for stimulating the nerves, the electrical stimulation of the nerves is also a frequently used method. The nerves may be stimulated by sending electrical signals to various nerves from various parts. The stimulation is realized via different parts of different nerves by means of the signals of different electrical property for treating different disorders. Although the properties of the stimulation signal to be sent vary according to the disorder intended to be treated, not every stimulation exhibits the same effect in every patient. Accordingly, it is of great importance to be able to determine the correct current parameters for improving the efficacy and safety of the treatment. Various biofeedback systems are utilized for the identification of the correct current parameters. On the other hand, although different effects are attempted to be obtained by varying the current parameters such as frequency, pulse width, waveform and the like, the vagus nerve is always stimulated via biphasic current.

US2020179689A1 discloses a system and a method developed for the treatment of migraine attacks. According to the said system, the electrodes are attached to the forehead of a patient and the stimulation of the trigeminal nerve is provided via the electric signals for the purpose of treating the migraine attacks.

US2015142082 similarly aims at treating a disorder via the electrical stimulation of the nerve. The said system differs in that it comprises a biological feedback mechanism. In the system and method disclosed in this document, after the stimulation of the nerve with an electrical signal, the physiological outputs of the patient are measured to determine their responses to said stimulation. Said physiological output may be a value such as the pulse variability, electrocardiogram, blood flow and finger temperature. Said values are measured with the help of various sensors and the electrical signals sent for stimulating the nerve are revised in line with the measured values.

Stimulation of the vagus nerve via biphasic current causes an increase in the nerve activity. However, the hyperactivity of parasympathetic nervous system and vagus is observed in case of hypersomnia, allergy and some similar diseases, and it is required to reduce this hyperactivity. Further, side effects may develop in the individuals as a result of hyperstimulation of the vagus nerve and it is required to suppress the vagus nerve, even if for a short time. With the method and the system according to the invention, it is made possible to stimulate the vagus nerve with an intermittent direct current and it is also made possible to stimulate the vagus nerve in an opposite manner by way of adjustment of the current direction.

Object of the Invention

An object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve.

Another object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve by an intermittent direct current.

Another object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve via the ear.

Another object of the invention is to develop a system and a method wherein it is possible to set the electrodes such that they will exhibit polarity as an anode as well as a cathode depending on preference and thus it is possible to stimulate the vagus nerve in an opposite manner.

Figure 1: A side view of the stimulator and the earpiece

Figure 2: A rear view of the stimulator and the earpiece

Figure 3: A front view of the stimulator

Figure 4: A view of the earpiece

Figure 5: A view of the stimulator

Figure 6: A graph showing the stimulation with intermittent direct current Reference Numerals

S : Stimulator

1 : Elastic piece

21 : Nape electrode

22 : Concha ear electrode

23 : Tragus ear electrode

3 : Sensor

4 : Cable

5 : Cable output

61 : Body end portion

62 : Body middle portion

63 : Cable output portion

7 : Control member

8 : Visual warning member

Detailed Description of the Invention

Auricular vagus nerve electrical stimulation (aVNS) is a developing technology for the therapeutic practices in the field of bioelectronic medicine. The modulation of the afferent vagus nerve affects a great number of physiological processes and physical conditions associated with the transfer of information between the brain and the body. This method has treatment-enhancing effects for various diseases such as chronic pain, neurodegenerative and metabolic disorders, inflammatory and cardiovascular diseases (Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9; 13: 854). It is possible for the fibers to be locally overstimulated and understimulated during the vagus nerve stimulation. While the needle electrodes typically act as polarizable electrodes for the percutaneous vagus nerve simulation (VNS), the surface electrodes may serve as non- polarizable electrodes for transcutaneous aVNS. Monopolar aVNS offers the most diffuse stimulation with the lowest stimulation threshold. Monophasic stimulation leads to depolarization or hyperpolarization in an exposed terminal near the electrode or at a location of bending (Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Lechner S, Klonowski W, Varoneckas G, Szeles JC, Sarolic A. Current Directions in the Auricular Vagus Nerve Stimulation II - An Engineering Perspective. Front Neurosci. 2019 Jul 24; 13: 772). Monophasic rectangular pulses with varying polarity were used in the percutaneous auricular branch of vagus nerve stimulation (Kampusch, S., Kaniusas, E., and Szeles, C. (2013). "New approaches in multipunctual percutaneous stimulation of the auricular vagus nerve," in Proceedings of the 6th International IEEE/EMBS Conference on Neural Engineering (NER) 2013, (San Diego, CA: IEEE), 263-266. doi: 10.1109/ner.2013.6695922). While anode stimulation increases the response of a neuron to a certain synaptic input, the cathodal stimulation reduces the response, though to a lesser extent (Belen Lafon, Asif Rahman, Marom Bikson, Lucas C. Parra. Direct Current Stimulation alters neuronal input/output function. Brain Stimul. 2017; 10(1): 36-45). The intermittent direct current may be preferable for transcranial stimulation and may affect the autonomic nervous system activity (Leon Morales-Quezada, Camila Cosmo, Sandra Carvalho, Jorge Leite, Laura Castillo-Saavedra, Joanna R. Rozisky, Felipe Fregni. Cognitive effects and autonomic responses to transcranial pulsed current stimulation. Exp Brain Res (2015) 233: 701-709).

In a study by Clancy et al., anodal transcranial direct current stimulation of the motor cortex shifted the autonomic nervous system balance towards the sympathetic dominance due at least partly to the increased sympathetic output; however, no significant change was detected in the cathode group (Clancy JA, Johnson R, Raw R, Deuchars SA, Deuchars J. Anodal Transcranial Direct Current Stimulation (tDCS) Over the Motor Cortex Increases Sympathetic Nerve Activity. Brain Stimul. 2014 Jan-Feb; 7(1): 97-104). It may be said that the electrode polarity could influence the autonomic nervous system activity in a different way (Brunoni AR, Vanderhasselt MA, Boggio PS, Fregni F, Dantas EM, Mill JG, Lotufo PA, Bensenor IM. Polarity- and valence-dependent effects of prefrontal transcranial direct current stimulation on heart rate variability and salivary cortisol. Psychoneuroendocrinology. 2013 Jan; 38(1): 58-66). Reversing the polarity of the stimulation usually causes opposite effects on the transcranial direct current stimulation, but this is not always the case (Das S, Holland P, Frens MA, Donchin O. Impact of Transcranial Direct Current Stimulation (tDCS) on Neuronal Functions. Front Neurosci. 2016 Nov 30; 10: 550).

Auricular vagus nerve stimulation sends the signals first to the solitary tract nucleus in the brain stem. Therefore, it may be considered or accepted as a cranial neuromodulation method. Referring to the studies on the peripheral nerves, the direct current stimulation has a long-lasting effect on H-reflex by modulating the excitability of sensory and motor fibers in the human posterior tibial nerve. Cathodal direct current stimulation (DCS) considerably increases the H-reflex and M-wave amplitude; on the contrary, anodal direct current stimulation considerably reduces the amplitudes. The effect of the direct current stimulation may continue also after it is terminated. However, this condition lasts longer in the H-reflex as compared to the M-wave. Similar results were observed in the mice tests (Bolzoni F, Esposti R, Bruttini C, Zenoni G, Jankowska E, Cavallari P. Direct current stimulation modulates the excitability of the sensory and motor fibers in the human posterior tibial nerve, with a long- lasting effect on the H-reflex. Eur J Neurosci. 2017 Nov; 46(9): 2499-2506).

Bastos et al. investigated how the distance between the electrodes affects the spatial distribution of the electric field in the lumbar and sacral spinal cord during the transcutaneous spinal direct current stimulation. Increasing the inter-electrode distance results in a wider electric field distribution with greater maximum peak values and a smoother variation along the spinal cord. The results indicate that the choice of the position of the return electrode relative to the target could affect the electric field size distribution and value interval (Bastos R, Fernandes SR, Salvador R, Wenger C, de Carvalho MA, Miranda PC. The Effect of InterElectrode Distance on the Electric Field Distribution during Transcutaneous Lumbar Spinal Cord Direct Current Stimulation. ConfProc IEEE EngMedBiolSoc. 2016 Aug; 2016: 1754-1757).

According to our invention, the electrodes are arranged such that one is positioned in the ear and the other with an opposite pole is positioned distally in the neck. Most of the nerve fibers in the external ear extend from the cervical region. The greater auricular nerve located in the inferior and posterior sections of the auricle is a superficial branch of cervical plexus contributed by the fibers extending from C2 and C3 spinal nerves (Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr; 236(4): 588-611).

The greater auricular nerve is located adjacent to the vagus nerve and a part of the fibers are intertwined. Positioning the opposite electrode longitudinally, especially in the C2-C3 dermatomes, may create an additional effect for the vagus nerve stimulation due to such proximity. Owing to this proximity, the electrical loop may be completed easily.

There are very few studies on the cervical transcutaneous trans-spinal direct current stimulation. Nierat et al. studied the effects of the anodal, cathodal and sham transcutaneous spinal direct current stimulation transmitted to the C3-C5 level. Cathodal trans-spinal direct current stimulation caused a permanent increase in the tidal volume, but the same situation was not detected in the anodal stimulation. Additionally, the autonomic functions were not affected by the trans-spinal direct current stimulation. The researchers stated that the cathodal trans-spinal direct current stimulation opens the perspective for use as a therapeutic means for the management of various respiratory disorders (Nierat MC, Similowski T, Lamy JC. Does Trans-Spinal Direct Current Stimulation Alter Phrenic Motoneurons and Respiratory Neuromechanical Outputs in Humans? A Double-Blind, Sham-Controlled, Randomized, Crossover Study. The Journal of Neuroscience, 10 October 22, 2014, 34(43): 14420-14429). The sensation of electric current on the skin is associated with the amount of electric current per unit area. When the same amount of electric current is applied over a greater area, the electric current is perceived by the individual to a smaller extent. The surface area of the electrodes to be positioned in the neck (nape) within the scope of the invention will be greater than the surface area of their equivalents in the ear or will be equal to the surface area of their equivalents in the ear. Owing to the greater surface area, the current will be sensed or started to be sensed first in the ear. This will allow the current intensity to be adjusted via the vagus nerve dermatome. Since the primary aim is to correctly stimulate the vagus nerve and thereby regulate the autonomic nervous system activity, the electrode surfaces in the neck will be preferably greater than those of the electrodes in the ear.

The system and device according to the invention comprise in their most basic form at least one electrode enabling to stimulate the vagus nerve and at least one stimulator (S) enabling to conduct electric current to the electrode.

A preferred embodiment of the invention comprises at least two electrodes. According to said embodiment, at least one of the electrodes sends signal to an area where the auricular vagus nerve is present and another electrode sends signal to an area outside the vagus nerve. In a preferred embodiment, at least one of the electrodes is located in the ear and another electrode is located in the nape. The nape electrode (21) is shown in Figure 2 and Figure 3, and the ear electrode is shown in Figure 4.

In a preferred embodiment of the invention, the nape electrode (21) is positioned in a quantity of at least two, one on the right ear side and the other on the left ear side, as can be seen in Figure 2 and Figure 3.

In a preferred embodiment of the invention, the ear electrodes are present in a total quantity of four, i.e. two electrodes, namely the concha ear electrode (22) and tragus ear electrode (23), in each ear. Of the ear electrodes, at least one of the concha ear electrode (22) and tragus ear electrode (23) may be active.

The electrode required to perform the stimulation has a surface area that contacts the skin surface or beneath the skin surface and has a transmission energy field for an effective treatment within the safety limits according to the current intensity. The electrical connection of the stimulator (2) (Figure 5) with the patient may be ohmic or capacitive. There are present two cables (4) and two cable outputs (5) connecting the stimulator (2) to the ear electrodes. The cable output portion (63) where said cable output (5) is present has a relatively elastic structure. The body end portion (61) and the body middle portion (62) containing the stimulator (S) parts like battery and electronic card are manufactured from a more rigid plastic material. At least one control member (7), more specifically at least one on/off button, is present on the stimulator (S). At least one visual warning member (8) indicating the status of the device is present on the stimulator (S). The parts of the device such as battery and electronic card are positioned in the body middle portion (62). The elastic piece (1), which enables the device to remain fixed in the user's ear, extends around the earlap to enable the electrodes to remain stable. The device additionally comprises at least one signal generator generating the signal to be sent from the electrodes, a power supply connected to the generator, and a control unit connected to the former two.

In a preferred embodiment of the invention, the device comprises at least one sensor (3), which enables feedbacks to be obtained from the patient following the stimulation. According to the feedbacks obtained via said sensor (3) from the patient, it is possible to alter the polarity of the electrodes as well as other stimulation parameters. While the sensor (3) is not in contact with the skin when the device is in the off state, it is able to contact the skin by extending between the electrodes by means of a spring system when the device is turned on.

In a preferred embodiment, the device comprises the sensors (3) such that there is at least one sensor in each ear.

An intermittent direct current is supplied to the electrodes by the stimulator (S). In a preferred embodiment of the invention, the pulse duration varies between 40 ps and 150 ps.

In a preferred embodiment of the invention, the inter-pulse interval of the current varies between 50 ps and 1 s.

In a preferred embodiment of the invention, the frequency is a value varying between 1 Hz and 1000 Hz.

In a preferred embodiment of the invention, the current intensity may be adjusted up to 4 mA with a precision of 0,1 mA.

In the system developed within the scope of the invention, the supply of a controlled current is made possible owing to the ability to adjust the mentioned properties of the current.

In a preferred embodiment of the invention, the dimensions, more specifically the surface areas, of the electrodes positioned in the ear and the nape are different from each other. For example, the surface area of the nape electrode (21) positioned in the nape may adjusted such that it will be greater than the surface area of the tragus ear electrode (23) or the concha ear electrode (22). Having a greater electrode surface area in the neck region enables the amplitude adjustment to be made according to the vagus. As the electrode surface area increases, the current intensity per unit area and the individual's extent of sensation of the current decrease. Since the primary objective is to stimulate the vagus nerve in the ear, the current intensity is adjusted according to the current sensation in the ear.

In an alternative embodiment of the invention, the surface areas of the electrodes, i.e. the surface areas of the tragus ear electrode (23) and the concha ear electrode (22) and the nape electrode (21), are the same. In a preferred embodiment of the invention, one of the ear electrodes, i.e. one of the tragus ear electrode (23) or the concha ear electrode (22), becomes active. The system may automatically decide which electrode will be active, before the start of stimulation or during the stimulation, or, the active electrode may be selected by the user. Since the distribution of the vagus nerve in the ear may exhibit variation among the individuals, the tragus or concha stimulation may yield different responses among the individuals. That the ear electrode (tragus or concha) is selectable makes it possible for the stimulation to become more effective.

In a preferred embodiment of the invention, the electrodes may be set as anode or cathode. In other words, which electrode will act as an anode and which electrode will act as a cathode may be set. It is possible to separately assess the polarity of the electrodes and alter the same independently of one another. The current direction changes and different stimulations are obtained depending on the alteration of the polarity of the electrodes. Since altering the current direction alters the neuronal polarization/depolarization, an extra ability of control is provided on the nerve activity. Operation of said electrodes as anode or cathode is controlled by the stimulator (S).

In a preferred embodiment of the invention, the nape electrodes (21) have an adhesive character. In this way, the weight of the stimulator (S) may be borne partially also by these electrodes.

In a preferred embodiment of the invention, the stimulator (S) is controlled via a smart device. In a preferred embodiment of the invention, the smart device is a mobile phone and is capable of wirelessly communicating with the stimulator (S).

The sensor (3) or sensors (3) used within the scope of the invention may measure the personal values like the pulse, pulse variability, body temperature, skin resistivity, and evoked potential from any part of the body outside the ears; or, in addition to these measurements, they may measure like the ear secretion pH and the liquid, electrolyte and fat contents of the ear secretion from the ears, via a smart wristband, mobile phone application. In the system according to the invention, the right and left side intermittent direct current stimulation will be adjusted independently. While the current may be supplied simultaneously to both sides, it is also possible that the current is supplied only to the right side or the left side. Or, the stimulation may be applied alternately, i.e. may be applied to the right ear for a certain time and to the left ear for a certain time. The system may decide which of the electrodes will be active and which of the electrodes will be passive, or the user may make the decision in this regard in the beginning, and the system may switch the active electrode into the passive state or the passive electrode into the active state during the application. The system may decide which of the electrodes in one ear (the tragus ear electrode (23) or the concha ear electrode (22)) will be active or the operator may make this selection by their will in the beginning. The system may make changes regarding the active state between the ear electrodes during the application. In other words, the currently active electrode may switch into the passive state and the currently passive electrode may switch into the active state. While the tragus ear electrode (23) may be active in one ear, the concha ear electrode (22) may be active in the other ear. The system decides which one of the electrodes will be positive and which one will be negative according to the data received from the sensors (3). For instance, the electrode (tragus or concha) in one ear may be in the positive pole, while the electrode (tragus or concha) in the other ear may be in the negative pole. In addition to the polarity of the electrodes, the system may alter the other stimulation parameters such as waveform, duration, phase, intensity, frequency and pulse width according to the data received from the sensors (3).

An exemplary mode of operation for the device and system according to the invention may be as follows: The intermittent direct current stimulation is initiated by the stimulator (S) such that the left ear concha ear electrode (22) is positive, the left side nape electrode (21) is negative, the right ear concha ear electrode (22) is positive, and the right side nape electrode (21) is negative. According to the data obtained from the sensors (3), the electrode polarities on the left side are changed such that the concha ear electrode (22) will be negative and the nape electrode (21) will be positive. No change is made on the right side. After the stimulation has continued for a certain time, the frequency value of the current supplied to the left side is increased, the right side concha ear electrode (22) is disabled and the tragus ear electrode (23) is activated, again based on the information received from the sensors (3). At the instance where the vagus nerve activity or the autonomic nervous system activity has reached the desired value, the system may continue the stimulation applied until that moment, without making any change, or may send a signal to the user, or may automatically terminate the stimulation. The disclosed procedure is intended to exemplify the method of operation according to the invention and is not limiting.

In case the vagus nerve stimulation is not sufficient enough or in case the vagus nerve stimulation is excessive or in order to suppress the vagus nerve, the system may alter the electrode polarities or electrode activities (tragus or concha), i.e. the system may alter the active or passive state of the tragus ear electrode (23) or the concha ear electrode (22).

In case the vagus nerve stimulation is not sufficient enough or in order to suppress the vagus nerve, the system may, in addition to the electrode polarity change or active electrode changes, i.e. alteration of the active or passive state of the electrodes, also alter the stimulation parameters such as waveform, duration, phase, intensity, frequency, pulse width and inter-pulse interval, etc.

In the system according to the invention, it is made possible to more effectively control the nerve activity owing to the nerve stimulation via the alteration of the current direction, the risk for side effects is reduced as a result of the stimulation with intermittent direct current, and the efficacy is enhanced by adding the frequency feature to the current.

Claims

1. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve characterized in that the system is a system enabling the vagus nerve to be stimulated by intermittent direct current, and the device comprises at least one electrode enabling to stimulate the vagus nerve and at least one stimulator (S) enabling to conduct intermittent direct current to the electrode.

2. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 1 characterized in that it comprises at least two electrodes.

3. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 2 characterized in that the electrodes are the electrodes, at least one of which is positioned in the area where the auricular vagus nerve is present and another one of which is positioned in an area outside the vagus nerve.

4. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 2 characterized in that the electrodes are the electrodes, at least one of which is an electrode positioned in the ear and another one of which is a nape electrode (21) positioned in the nape.

5. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 4 characterized in that the ear electrodes comprise at least two electrodes in each ear, namely at least one concha ear electrode (22) and at least one tragus ear electrode (23).

6. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the dimensions, more specifically the surface areas, of the concha ear electrode (22) and the tragus ear electrode (23) and the nape electrode (21) are different from one another.

7. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of Claims 1-5 characterized in that the dimensions, more specifically the surface areas, of the concha ear electrode (22) and the tragus ear electrode (23) and the nape electrode (21) are the same.

8. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of Claims 1-6 characterized in that the surface area of the nape electrode (21) positioned in the nape is greater than the surface area of the concha ear electrode (22) and the tragus ear electrode (23).

9. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that it comprises at least one control member (7) on the stimulator (S).

10. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 9 characterized in that said control member (7) is an on/off button.

11. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that it comprises on the stimulator (S) at least one visual warning member (8), which indicates the status of the device.

12. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that it comprises at least one sensor (3), which enables feedbacks to be obtained from the patient following the stimulation.

13. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 12 characterized in that it comprises the sensors (3) such that at least one sensor (3) is present in each ear.

14. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the pulse duration of the electric current sent by the stimulator (S) is in the range of 40 .s-150 .s.

15. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the interpulse interval of the electric current sent by the stimulator (S) is in the range of 50 .s-1 s.

16. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the frequency of the electric current sent by the stimulator (S) is in the range of 1 Hz-1000 Hz.

17. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the electric current sent by the stimulator (S) is an electric current the intensity of which may be increased up to 4 mA.

18. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the electric current sent by the stimulator (S) is an electric current the intensity of which may be adjusted up to maximum 4 mA with a precision of 0,1 mA.

19. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that it is a system where the electrode may be set as anode or cathode via the stimulator (S).

20. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 19 characterized in that it is a system where the polarity of each electrode may be set as anode or cathode independently of one another.

21. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 19 or Claim 20 characterized in that it is a system where the current direction is altered by altering the polarity of the electrodes.

22. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to Claim 21 characterized in that it is a system where the current direction is altered in order to alter the neuronal polarization/depolarization.

23. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the stimulator (S) is a stimulator (S) able to be controlled via a smart device.

24. A system and a device for treating the diseases and/or disorders by way of stimulation of the vagus nerve according to any one of the preceding claims characterized in that the stimulator (S) is a stimulator (S) capable of wirelessly communicating with a smart device.

25. A method for treating the diseases and/or disorders by way of stimulation of the vagus nerve characterized in that the auricular vagus nerve is stimulated by intermittent direct current.

26. A method according to Claim 25 characterized in that the vagus nerve is stimulated by means of at least one electrode and the conduction of the intermittent direct current to the electrode is provided via at least one stimulator (S).

27. A method according to Claim 25 or Claim 26 characterized in that the vagus nerve stimulation is realized by means of at least one concha ear electrode (22) or at least one tragus ear electrode (23) on the right and left ears and at least one nape electrode (21) in the neck region.

28. A method according to Claim 27 characterized in that the intermittent direct current stimulation in the right and left ears is adjusted independently of each other, the current may be supplied simultaneously to both sides and it is also possible to supply current only to the right ear or only to the left ear.

29. A method according to Claim 27 characterized in that the intermittent direct current stimulation in the right or left ear is applied in an alternating manner; i.e. the intermittent direct current stimulation is applied for a certain time to the right ear and for a certain time to the left ear.

30. A method according to Claim 27 characterized in that the system is able to alter the polarity of the electrode poles, i.e. which one of the electrodes will be positive and which one will be negative, and additionally, the other stimulation parameters such as waveform, duration, phase, intensity, frequency and pulse width, according to the data received from at least one sensor (3).

31. A method according to Claim 27 characterized in that the system decides which one of the concha ear electrode (22) or the tragus ear electrode (23) will be active and which one will be passive in the ear or the operator determines the same by their will in the beginning.

32. A method according to Claim 27 or Claim 31 characterized in that the system may switch the currently active electrode into the passive state and the currently passive electrode into the active state during the application.

33. A method according to Claim 27 or Claim 30 characterized in that the system decides which one of the electrodes will be positive and which one will be negative.

34. A method according to any one of Claims 25-33 characterized in that an electric current with pulse duration in the range of 40 p.s-150 ps is sent by the stimulator (S).

35. A method according to any one of Claims 25-34 characterized in that an electric current with inter-pulse interval in the range of 50 ps-1 s is sent by the stimulator (S).

36. A method according to any one of Claims 25-35 characterized in that an electric current with frequency in the range of 1 Hz-1000 Hz is sent by the stimulator (S).

37. A method according to any one of Claims 25-36 characterized in that an electric current the intensity of which may be increased up to 4 mA is sent by the stimulator (S).

38. A method according to any one of Claims 25-37 characterized in that an electric current the intensity of which may be adjusted up to maximum 4 mA with a precision of 0,1 mA is sent by the stimulator (S).

39. A method according to any one of Claims 25-38 characterized in that the electrodes may be set as anode or cathode by means of the stimulator (S).

40. A method according to any one of Claims 25-39 characterized in that the polarity of each of the electrodes may be set as anode or cathode in a manner independent from one another.

41. A method according to Claim 39 or Claim 40 characterized in that the polarity of the electrodes is altered and the current direction is altered by altering the polarity.

42. A method according to Claim 41 characterized in that the neuronal polarization/depolarization is altered as a result alteration of the current direction.

43. A method according to any one of Claims 25-42 characterized in that at the instance where the vagus nerve activity or the autonomic nervous system activity has reached the desired value, the system continues the stimulation applied until that moment, without making any change, or sends a signal to the user, or automatically terminates the stimulation.

44. A method according to any one of Claims 25-43 characterized in that in case the vagus nerve stimulation is not sufficient enough or in case the vagus nerve stimulation is excessive or in order to suppress the vagus nerve, the system alters the electrode polarities or electrode activities, i.e. the active or passive state of the tragus ear electrode (23) or the concha ear electrode (22), or alters the stimulation parameters such as waveform, duration, phase, intensity, frequency, pulse width and inter-pulse interval.