RU2812398C1 - Device and method of electrical stimulation of nerve tissue - Google Patents

Abstract

FIELD: medical devices.

SUBSTANCE: group of inventions relates to variants of the method of non-invasive electrical stimulation of nervous tissue of the central nervous system and devices for their implementation. The devices contain two electrodes, a control unit and a unit for generating single electrical pulses of a predominantly symmetrical shape. At least one electrical impulse is generated and the nervous tissue is stimulated by the generated impulse by acting on the skin. The amplitude value of the pulse over time has six sections located one after the other: the first section, in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero. The modulus of the maximum value is greater than the modulus of the first minimum value and the modulus of the second minimum value. In another embodiment of the electrical stimulation method, the amplitude value of the pulse over time has the form of the second derivative of the Gaussian function.

EFFECT: ensuring the formation of a pulse of uniform magnitude and shape of potentials in time in all areas of the action of the current, as well as low distortion of the pulse in the tissues during exposure.

73 cl, 3 dwg

Description

Field of technology to which the invention relates

The device and method relate to medical equipment, as well as methods of exposure (stimulation) with electric current. This approach can be used for non-invasive stimulation of the central nervous system and central neuroendocrine system as the main or auxiliary method of treating pathological conditions, enhancing the adaptive capabilities of the body, modulating psychological states to optimize activity under stressful operating conditions.

Exposure through head cutaneous electrodes activates brain structures, which leads to effects aimed at optimizing neural structures. Such an effect harmonizes the work of the brain and brings it to a state that is most appropriate to the current state of the body. Neurostimulation, as one example of electrical stimulation, is a method of activating the work of structures that ensure optimization of the central neuroendocrine system. In this case, the effect is carried out by passing a pulsed current through electrodes applied to the patient’s scalp. The placement of electrodes allows you to achieve an effect on the brain as a whole or provides a local effect.

State of the art

The most common method of generating impact pulses is the method of interrupting the current from the power source. Known solutions offer various methods of influencing and generating current pulses. For example, RF patent No. 2654269 - Method of transcranial magnetic stimulation, IPC A61N 2/02, discloses a method of transcranial magnetic stimulation, which consists of exposure to a magnetic field generated by inductor coils, which are moved around the recipient’s head in a circular arc, with the center of rotation of the trajectory of the coils moving passes through the brain stimulation zone. The method can be used in technologies for activating creative abilities, accelerating and increasing cognitive resources for young and elderly people. The disadvantages of this method are the bulkiness of the design, the inability to use the device during physical activity, the duration and complexity of stimulation, and the need for manipulation by a specialist, which may cause an increase in the estimated cost of the device.

RF Patent 2297253 – Transcranial electrical stimulator (options) and a device for fastening electrodes of a transcranial electrical stimulator, A61N 1/36, 2007, offers options for devices and fastening electrodes for electrical stimulation, where the impact parameters are the amplitude and duration of the impulse, the repetition period. The disadvantages of such an effect are the uncertainty of the temporal shape of the signal directly in the area of action - on the surface of a single neuron.

This is due to the fact that human tissues including skin, adipose, bone and nervous tissue, as well as biological fluids, have a pronounced reactive component in conductivity. Moreover, this reactive component varies greatly for different types of biological tissues and liquids and at the same time is highly dependent on the frequency at which the impact is made. A set of such sections in the current flow circuit leads to a distortion of the original signal shape, while a significant part of the pulse energy is consumed in the form of thermal energy, which also complicates or makes the dosage of the effect poorly controlled and dependent on the patient’s characteristics and methods of applying electrodes.

RF patent 2522850 – Non-invasive neurostimulation system, A61N 1/36, 2014, discloses a device with an electronic control mechanism for delivering a sequence of electrical pulses of relatively high voltage but short duration to the patient’s skin. To influence an object, energy is first stored in inductance and connected to the circuit with the patient.

In this case, the object of influence is included in the oscillatory circuit, as a result of which a damped sinusoidal pulse is formed in the patient circuit. One of the disadvantages of this method is the dependence of the amplitude and frequency of oscillations and the decay time on the current values of the impedance between the electrodes, which does not allow for the constancy and consistency of the effect on the tissue by current pulses in such a way as to ensure a uniform value and shape of potentials in time in all zones of current passage .

Disclosure of the Invention

The objective of the present invention is to provide a consistent effect on tissue by current pulses in such a way as to ensure a uniform value and shape of potentials over time in all zones of current passage. In other words, one of the important aspects of the electrical stimulation effect according to the proposed method and device is the uniformity of the temporal shape of the potentials arising from the hardware effect in all areas of the current action.

The technical result consists in the formation in all areas of the current action of a pulse of uniform magnitude and shape of potentials over time. Another result is low pulse distortion in tissue during exposure of tissue to current pulses.

In some embodiments, the device for electrically stimulating neural tissue comprises at least two electrodes; Control block; an electrical pulse generation unit, configured to generate single electrical pulses of a predominantly symmetrical shape, such that the graph of the pulse amplitude over time has six consecutive sections: the first section, in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value.

In some embodiments, the device further comprises a trigger pulse generator configured to generate trigger pulses for the electrical pulse generation unit.

In some embodiments, the trigger pulse generator is configured to generate bursts of trigger pulses with a specified at least one of the following parameters: interval between bursts, interval between pulses in a burst, number of pulses in a burst.

In some embodiments, the trigger pulse generator is configured to generate a sequence of trigger pulses with random intervals between pulses within specified minimum and maximum interval values.

In some embodiments, the device further comprises at least one second electrical pulse generating unit.

In some embodiments, the device further comprises an adder configured to aggregate electrical pulses generated by the electrical pulse generating unit and the at least one second electrical pulse generating unit.

In some embodiments, the adder is further configured to aggregate electrical pulses by superimposing them on each other with partial overlap.

In some embodiments, the device further comprises a level controller configured to receive an electrical pulse from an electrical pulse generating unit or adder and transmit it further along the electrical circuit of the device with a given transmission ratio.

In some embodiments, the device further comprises a voltage-to-current converter configured to stabilize the waveform of the supplied current in the event of a change in circuit impedance.

In some embodiments, the device further comprises a current and voltage measurement unit.

In some embodiments, the control unit is coupled to the trigger generator and includes a microcontroller.

In some embodiments, the control unit includes a memory unit and a microprocessor configured to execute program code stored in the memory unit.

In some embodiments, the device further comprises a patient circuit monitoring unit configured to monitor the achievement of specified electrical parameters when the patient is connected to the circuit.

In some embodiments, the device further comprises an interface unit. Moreover, in some embodiments, the interface block contains at least one of:

•button,

•light indication device,

•display,

•touch control panel.

In some embodiments, the electrical pulse generation unit is configured to generate single electrical pulses of a smooth shape. In some embodiments, the electrical pulse generation unit is configured to generate single electrical pulses whose first minimum value is equal to the second minimum value.

In some embodiments, the electrical pulse generation unit is configured to generate single electrical pulses in which the modulus of the maximum value is equal to the sum of the moduli of the first minimum value and the second minimum value.

In some other embodiments, the electrical pulse generation unit is configured to generate single electrical pulses in which, on a graph of changes in pulse amplitude over time, the area under the part of the graph with positive amplitude values is equal to the area above the part of the graph with negative amplitude values.

In some other embodiments, the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the form of a “Mexican hat” wavelet or a Coiflet wavelet or a Daboshi db4 wavelet or a Simlet wavelet.

In some embodiments, the electrical pulse generating unit is configured to generate single electrical pulses in which the pulse amplitude versus time graph is at least partially in the form of a Morlet wavelet or a Meyer wavelet.

In some embodiments, the electrical pulse generation unit is configured to generate single electrical pulses whose maximum amplitude is in the range of 0.05-10 mA.

In some embodiments, the electrical pulse generating unit is configured to generate single electrical pulses having a pulse duration in the range of 2-100 ms.

In other embodiments, the electrical pulse generation unit is configured to generate single electrical pulses, in which, on a graph of changes in pulse amplitude over time, the distance between two adjacent extrema is in the range of 0.3-50 ms.

In some embodiments, the device is configured to generate electrical pulses at a frequency of up to 600 pulses per second.

In some embodiments, the device is configured to connect to

•one or more biofeedback systems (BFB),

•mobile device,

•computer.

In other embodiments, the device is configured with at least one of the electrodes for attachment to the patient's scalp, or to the patient's ear, or to the patient's eye area, or to the patient's scalp or neck in the area of the vagus nerve projection.

As will be appreciated by one skilled in the art, this approach can also be applied to animal husbandry. In this case, it is possible to use other (increased) values and ranges of current and pulses, for example, up to 50mA.

Also within the framework of the present solution, a method of electrical stimulation of nervous tissue is proposed. In some embodiments, a method of electrically stimulating neural tissue includes generating at least one electrical pulse in which the amplitude of the pulse over time has six sequential sections: a first section in which the amplitude decreases from zero to a first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value to zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value; and stimulation of nervous tissue by the generated impulse through action on the skin.

In some variants of the method, the generation of at least one electrical pulse is performed by a device having at least two electrodes, a control unit, and an electrical pulse generation unit.

In some embodiments, the method further includes generating electrical pulses with a specified at least one of the following parameters: interval between bursts, interval between pulses in a burst, number of pulses in a burst.

In some embodiments, the method further includes generating a sequence of electrical pulses with intervals between pulses determined by a random law within specified minimum and maximum interval values.

In some embodiments, the method further includes generating at least one electrical pulse, including generating multiple electrical pulses and aggregating them in a partially overlapping manner.

In some embodiments of the method, the generated at least one electrical pulse has a smooth graph of the pulse amplitude over time.

In some embodiments of the method, the generated at least one electrical pulse has a first minimum value equal to a second minimum value.

In some variants of the method, the generated at least one electrical pulse has such maximum and minimum values of the pulse amplitude that the module of the maximum value is equal to the sum of the modules of the first minimum value and the second minimum value.

In some embodiments of the method, the generated at least one electrical pulse has such a graph of the pulse amplitude over time that the area under the part of the graph with positive amplitude values is equal to the area above the part of the graph with negative amplitude values.

In some embodiments of the method, the generated at least one electrical pulse has a pulse amplitude versus time graph having the form of a Mexican hat wavelet or a Daboshi db4 wavelet or a Coiflet wavelet or a Simlet wavelet or, at least in part, a Morlet wavelet or a Meyer wavelet.

In some embodiments, the at least one electrical pulse generated has a maximum amplitude value in the range of 0.05-10 mA.

In some other embodiments, the at least one electrical pulse generated has a pulse duration in the range of 2-100 ms.

In other embodiments, the generated at least one electrical pulse has a graph of pulse amplitude over time in which the distance between two adjacent extremes is in the range of 0.3-50 ms.

In some embodiments of the method, generating at least one electrical pulse includes generating a plurality of electrical pulses at a frequency of up to 600 pulses per second.

In some embodiments of the method, stimulation of nervous tissue includes a build-up period and a stimulation end period.

In some variants of the method, during the period of increasing stimulation, the strength of the electrical current gradually increases, and this period lasts from 10 to 300 s;

During the end of stimulation period, the electrical current gradually decreases, and this period lasts from 3 to 15 s.

In some other variants of the method, during the period of increasing stimulation, the strength of the electrical current gradually increases; During the period of termination of stimulation, the strength of the electrical current gradually decreases, and the period of increase and the period of termination of stimulation are of equal duration.

In some embodiments of the method, stimulation occurs during a stimulation session lasting from 10 to 60 minutes.

In some embodiments of the method, stimulation is performed by affecting the patient's scalp or the skin of the patient's ear or the skin in the patient's eye area or the skin of the patient's neck or head in the area of the vagus nerve projection.

Also within the framework of this solution, a system for electrical stimulation of nervous tissue is proposed. In some embodiments, the system for electrically stimulating neural tissue comprises at least two electrodes; Control block; an electrical pulse generation unit configured to generate single electrical pulses of a predominantly symmetrical shape, such that the graph of changes in pulse amplitude over time has six consecutive sections: the first section, in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value.

In some embodiments, the system includes a control unit and an electrical pulse generation unit, which are connected through at least one wire.

In some other embodiments, the system includes a control unit and an electrical pulse generation unit that are connected wirelessly.

In some embodiments, the electrical pulse generating unit is coupled to at least two electrodes via at least one wire.

In some other embodiments, the electrical pulse generation unit and at least two electrodes are made in a single body of the wearable device.

In some other embodiments, it additionally contains at least one additional block from the list: a trigger pulse generator, a second block for generating electrical pulses, an adder, a level controller, a voltage-to-current converter, a block for measuring current and voltage parameters; Patient circuit control unit.

In some versions of the system, at least one additional unit is structurally designed in a single housing with the electrical pulse generation unit.

In some variants of the system, the control unit contains at least one control element from the list: a microcontroller, a memory unit, a microprocessor configured to execute program code stored in the memory unit.

In some embodiments of the system, the control unit is at least part of one of: a computer, a mobile device, or a biofeedback system.

In some embodiments, the system includes an interface unit that is at least part of one of a computer, a mobile device, or a biofeedback system.

In some embodiments, the system contains an interface block comprising at least one of: a button, a light indication device, a display, or a touch control panel.

Also within the framework of the present solution, a non-transitory machine-readable medium is proposed. In some embodiments, a non-transitory computer-readable medium contains a set of instructions for a processor to control an electrical pulse generator, wherein the set of instructions allows the electrical pulse generator to generate electrical pulses of a predominantly symmetrical shape, in which the change in the amplitude value of the pulse over time has six sequential sections: a first section , at which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value to zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; and a sixth section in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value.

Also within the framework of this solution, another version of the device for electrical stimulation of nervous tissue is proposed. In some embodiments, the device for electrically stimulating nerve tissue comprises at least two electrodes; Control block; an electrical pulse generation unit configured to generate single electrical pulses, such that the graph of changes in the pulse amplitude over time has the form of the second derivative of the Gaussian function.

Also within the framework of this solution, another variant of the method for electrical stimulation of nervous tissue is proposed. In some other embodiments, a method of electrical stimulation of nervous tissue includes generating at least one electrical pulse, in which the amplitude value of the pulse over time has the form of the second derivative of a Gaussian function, and stimulating the nervous tissue with the generated pulse by applying it to the skin.

Brief description of drawings

In order to more accurately reflect the essence of the present invention and its advantages, reference is made to the following detailed description taken in conjunction with the accompanying drawings, in which:

Fig. 1 – single pulse generator according to the device implementation option;

Fig. 2 – block diagram of a device for electrical stimulation of nervous tissue;

Fig. 3 (a-c) – representation of some impulse characteristics according to the device implementation options.

Carrying out the invention

This technical solution is aimed at stimulating nervous tissue through electric current. Examples of such nervous tissue include neurons in the brain. In this case, stimulation is carried out transcranially, that is, through the patient’s skull. It is also possible to stimulate individual nerve endings, such as, for example, locations in the head area with exposure of the vagus nerve. In this case, the effect can be exerted in the area of close contact of the nerve to the skin - in the area behind the ear, at the point where the vagus nerve exits and adheres to the jugular vein. One of the important aspects of this solution is the generation of electrical impulses of a certain type, which will be discussed below. According to the accompanying drawings, FIG. Figure 1 shows an example of the implementation of a single pulse generator. When a trigger pulse (100 – “input”) arrives at the input S of the Trigger (102), a stable state is formed at the output, which allows the clock pulse generator (101) to generate pulses. The clock generator (101) generates pulse(s) with rates from 10*N to 500*N Hz. The clock pulse generator (101) generates pulses that are fed to the counting input of a binary pulse counter (103), which counts pulses and generates at the output a binary code of a number equal to the number of pulses at the input. The resulting binary number is fed to the address input of the memory module (104), the cells of which store the signal magnitude values recorded during production or before starting the generator. When the counter (103) reaches the maximum value N, an overflow signal is generated, which is sent to the “R” input of the RS flip-flop (102) and switches the output to state 0, which stops the clock generator (101). Thus, in N cycles of the clock pulse generator (101), all memory cells (104) are sequentially interrogated and signal magnitude values in binary form are sequentially generated at the memory output, which are supplied to the digital-to-analog converter (DAC) (105) and converted into a voltage proportional binary code (200 – “output”).

The general block diagram of the device according to this technical solution is shown in Figure 2. The device provides the application of up to three pulses simultaneously. For this, the circuit uses three independent pulse generators of a given shape - blocks (221, 222, 223). The trigger pulse generator (201) generates sequences of pulses at the outputs under the control of the microcontroller (207), which trigger the formation of single pulses of a given shape.

From the outputs of the blocks (221, 222, 223), the signal in analog form is supplied to the adder (203), where it is mixed and fed to the level controller (204), the transmission coefficient of which is set by the microcontroller taking into account the given program. Next, the signal is supplied to the voltage-to-current converter (205), from which it is supplied to the current and voltage parameter meter (206) to monitor the effectiveness of the effect on the patient (device user). The measured parameters are read by the microcontroller (207) and compared with the specified ones. If there is a significant deviation from the specified parameters, an indication signal is generated indicating a malfunction of the device (and/or one or more components, blocks, modules) or the patient circuit. From the output of the measurement unit (206), the signal is supplied to the electrode connection unit (210). The display unit (208) provides information to the user about the operating mode, the state of the patient circuit, time until the end of the session, etc. The control unit (209) contains buttons and controls for turning the device on and off, regulating the level of exposure, and selecting session parameters. The control unit (209) can be designed as a separate device, including using general-purpose household devices (smartphone). The control microcontroller provides setting the parameters of the trigger pulse generator (201), determining the duration and composition of the session, performing continuous monitoring of the impact parameters, and indicating the current state.

The level controller (204) allows you to receive an electrical pulse from the electrical pulse generation unit or adder (203) and transmit it further along the electrical circuit of the device with a given transmission coefficient. The voltage-to-current converter (205) is responsible for stabilizing the shape of the supplied current in the event of a change in impedance in the circuit.

Some aspects of the present invention utilize a pulse value table that may be stored on computer-readable media, in a device's read-only memory, and/or in a signal-generating means memory with an order value of a memory block, for example, 64 cells and an 8-bit cell width. As will be appreciated by one skilled in the art, implementations with other memory parameters and/or bit depths are possible. Accordingly, during operation, the table of pulse values is read sequentially for memory cells (104) so that signal magnitude values in binary form are sequentially generated at the memory output. Next, the sequence is reproduced during the specified clock cycles by the clock pulse generator (101). The control unit and the electrical pulse generation unit are configured to generate single electrical pulses of a predominantly symmetrical shape, such that the graph of changes in the pulse amplitude over time has six sections located sequentially one after another. The electrical pulse generation unit can accordingly be configured to generate electrical pulses in which, in a graph of changes in pulse amplitude over time, the area under the part of the graph with positive amplitude values is equal to the area above the part of the graph with negative amplitude values.

A device for electrical stimulation of nervous tissue may contain at least one block of electrodes (two electrodes) or several blocks of electrodes. The electrode (or block of electrodes) can be configured to be attached to the patient's scalp, or to be attached to the patient's ear, or to the patient's eye area. Also, one electrode (electrode block) can be configured to be attached to the patient’s scalp or neck in the area of the vagus nerve projection. As will be clear to one skilled in the art, other implementations of the electrode unit are also possible, depending on which specific nerve tissues are required to be stimulated.

The device can use variable amplitude, duration and intensity, and thus target different areas of the patient using different patterns. For example, the first and second pairs of electrodes may be pulsed for 100 seconds, or the first pair of electrodes for 50 seconds and the other pair of electrodes for 30 seconds. Different stimulation modes can be provided by multiplexing a single pulse generator or multiple pulse generators. In other words, the device allows the aggregation of electrical pulses generated by several electrical pulse generation units. In this case, aggregation of electrical pulses occurs by superimposing them on each other with partial overlap.

According to another aspect of the present invention, multiple electrodes are used to allow different pulse patterns to be applied to different electrodes.

In some aspects, the trigger pulse generator is configured to generate bursts of trigger pulses with a specified at least one of the following parameters: interval between bursts, interval between pulses in a burst, number of pulses in a burst. The number of electrical pulse generation units used is not limited: it is possible to use several generation units (generators).

In some aspects of the present invention, an impedance sensing pulse may be provided (alone or in conjunction with a work or treatment pulse). An impedance sensing pulse is applied to the skin at selected locations to measure the relative impedance of the body at those locations. The impedance sensing pulse and/or the response pulse from the skin allows you to select the most effective location for the treatment pulse, taking into account the location of the electrodes (hereinafter called the “active area” or “site”). It is generally assumed that areas of the skin with relatively low impedance provide more effective treatment and are thus active areas. A sequence of triggering pulses is supplied with intervals between pulses, for example, determined by a random law within specified ranges - the minimum and maximum values of the interval.

In addition to the above-discussed aspects of the present method and apparatus, the apparatus further includes monitoring circuitry for generating a visual and/or audio signal. This monitors changes in skin condition during treatment by changing the frequency of the sound or visual signal as the measured relative impedance changes during treatment. The device implements the function of dynamic current assessment based on monitoring.

This device allows you to generate, using a control unit and an electrical impulse generation unit, electrical impulses with specified parameters. In some aspects of the present invention, pulse sections are generated in the following manner based on the amplitude value of the current, as shown in Figure 3 (a-c). In FIG. 3(a-c) shows some examples of impulse responses according to device implementation options.

In the shown in FIG. 3(a) there are several sections: the first section, in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero.

In this type of exposure, the level of safety of use reaches characteristics at which the implementation of the device can be safely used with minimal medical supervision and without it. The spectral properties of the used pulse shape are such that it can easily be suppressed by a band-stop (notch) filter, which makes it possible to record the EEG without interrupting the effect, and therefore use the specified stimulation pulse in systems with biofeedback in real time.

This approach allows us to fundamentally expand the possibilities of using the device not only for therapeutic effects, but also for modulating natural states in a person’s everyday and professional activities, for example, activating attention, regulating rest, accelerating learning and adapting to rapidly changing environmental factors.

Other options for generating electrical pulses are also possible, for example, based on a graph of the change in pulse amplitude over time of a wavelet shape. In some embodiments, a specific type of wavelet may be a "Mexican hat", a Daboshi db4 wavelet (Figure 3(b)), a symlet family wavelet, a Coiflet (Figure 3(c)), a Hamming window, Morlet, Meyer, etc. P. The shape of the pulse can be strictly symmetrical, as in the case, for example, of the “Mexican hat” (other names - Mexican HAT, MHAT wavelet), or predominantly symmetrical, that is, having a certain degree of symmetry, but not being strictly symmetrical. Examples of pulses with a predominantly symmetrical shape can be pulses of the Daboshi db4 or Coiflet wavelet shape. In some embodiments, smooth shaped electrical pulses are generated. When generating electrical pulses, also, according to the specified method and device, a variant of the pulse with a graph of changes in the pulse amplitude over time of the form and/or shape of the second derivative of the Gaussian function can be implemented.

These pulse shapes have similar characteristics - in them the pulse begins from values close to or equal to zero with a region of decline to a certain minimum value, followed by a region of rise with a change in the direction of the current to a certain maximum value, then the pulse has a region of decline to a second minimum value with a second change current direction, followed by a region of rise to values equal to or close to zero. This form of impulse has a number of advantages in addition to those mentioned above. An impulse of this form is physiological, i.e. close in shape to the action potential curve of neurons. Moreover, within the framework of this pulse shape, it is possible to achieve electrical neutrality of the effect when the sum of the forward and reverse currents is zero. In this case, no additional electrical charge is transferred to the body tissues. Impulses of this shape are practically not distorted in brain tissue and other tissues. Such impulses superimpose well on each other and are organized into “spikes”, close in shape to the patterns of natural electrical impulses of the brain.

One aspect of the present technical solution is that the current parameters are preferably set in such a way that the effect is subthreshold - that is, below the activation potential of neurons. With this effect, the applied current does not create conditions for the activation of a neuron in a quiet state, but can activate a neuron close to the activation state. In some cases, if there are clinical recommendations (for example, during an epileptic attack), it is possible to use threshold and supra-threshold exposure values.

For example, single electrical pulses have pulse durations ranging from 2 to 100 ms. In this case, the distance between two adjacent time extremes lies in the range from 0.3 to 50 ms. The pulse train is set at a frequency of up to 600 pulses per second. Amplitude current values are set from 0.05 to 10 mA.

In accordance with one aspect of the present technical solution, the trigger pulse generator is configured to generate bursts of trigger pulses with a specified at least one of an interval between bursts, an interval between pulses in a burst, a number of pulses in a burst. Stimulation with electrical current pulses may include a rise period and the period of termination of current stimulation. Moreover, the period of current increase lasts from 10 to 300 s at the beginning of the effect, and the decay lasts from 3 to 15 s. Thus, the total duration of the exposure session can be from 10 to 60 minutes, taking into account several phases of increasing and decreasing current strength.

Pulse indicators (parameters) can be specified in the form of a table or a list of values for storage in a memory block. For example, for 64 cells (values) and a 9-bit DAC, the pulse parameters can be specified as an array of values: 0, 0, 0, -1, -1, -1, -2, -3, -5, -8, -12, -17, -24, -33, -44, -57, -71, -85, -98, -108, -114, -113, -102, -82, -52, -12, 36, 87, 139, 186, 223, 248, 255, 248, 223, 186, 139, 87, 36, -12, -52, -82, -102, -113, -114, -108, -98, -85 , -71, -57, -44, -33, -24, -17, -12, -8, -5, -3, -2, -1, -1, -1, 0, 0.

In other embodiments of the present invention, a calculation is used to populate a memory block with signal values based on the number of memory cells, the number of the memory cell, the number of binary bits in the memory cell (DAC width), and the selected value in the corresponding cell number. The specified pulse parameters, signal values, and duration of exposure can be stored in the form of instructions for storage on a permanent machine-readable medium, which will allow reproducing, respectively, a set of instructions for the processor to control the electrical pulse generator. A permanent machine-readable medium can be made both on the basis of signal generation and monitoring devices (oscilloscope), and household devices (computer, smartphone), as well as cloud information storage.

The device can be configured to connect and control one or more Biofeedback systems (BFB). An example of the implementation of such a device is specialized biofeedback tools and devices, as well as household appliances with an interface, including general purpose ones, such as a personal computer, mobile devices (smartphone, tablet, etc.). BOS allows you to show and display the status (indication) of electrode connection and readiness to induce electric current pulses. Thus, using remote control through the specified examples external to the device in question, interfaces are possible to dynamically control and evaluate the impact with the ability to adjust stimulation parameters. The device implements the possibility of therapeutic effects and monitoring the progress of effects without invasive procedures with the ability to track stimulation parameters.

As will be clear to one skilled in the art, the present solution can be implemented both as a device and as a system - a group of devices or units interconnected by wires and/or wireless communications. As a wireless data connection, various standard communications can be used, such as, for example, Bluetooth, Wi-Fi, UWB, ANT, etc. As part of the present solution, the system or device can also be configured to connect to external devices, networks or systems such as personal computers, mobile devices, biofeedback systems, EEG devices and others.

Although several embodiments of the present invention have been illustrated in the accompanying drawings and described in the above detailed description, it is clear that the invention is not limited to the disclosed embodiments, but is susceptible of numerous rearrangements, modifications and substitutions of parts and elements without departing from the scope and spirit of the invention.

Claims (142)

1. A device for non-invasive electrical stimulation of nervous tissue of the central nervous system, containing: at least two electrodes; Control block; a block for generating electrical pulses, configured to generate single electrical pulses of a predominantly symmetrical shape such that the graph of the change in pulse amplitude over time has six sequentially located sections: the first section in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value. 2. The device according to claim 1, further comprising a trigger pulse generator configured to generate trigger pulses for the electrical pulse generation unit. 3. The device according to claim 2, in which the trigger pulse generator is configured to generate bursts of trigger pulses with a given at least one of the following parameters: interval between bursts, interval between pulses in a burst, number of pulses in a burst. 4. The device according to claim 2, in which the trigger pulse generator is configured to generate a sequence of trigger pulses with intervals between pulses determined by a random law within the specified minimum and maximum interval values. 5. The device according to claim 1, further comprising at least one second unit for generating electrical pulses. 6. The device according to claim 5, further comprising an adder configured to aggregate electrical pulses generated by the electrical pulse generation unit and at least one second electrical pulse generation unit. 7. The device according to claim 6, in which the adder is additionally configured to aggregate electrical pulses by superimposing them on each other with partial overlap. 8. The device according to claim 6, additionally containing a level controller configured to receive an electrical pulse from an electrical pulse generation unit or adder and transmit it further along the electrical circuit of the device with a given transmission coefficient. 9. The device according to claim 1, additionally containing a voltage-to-current converter configured to stabilize the shape of the supplied current in the event of a change in impedance in the circuit. 10. The device according to claim 1, additionally containing a unit for measuring current and voltage parameters. 11. The device according to claim 2, in which the control unit is connected to a trigger pulse generator and contains a microcontroller. 12. The device according to claim 1, in which the control unit contains a memory unit and a microprocessor configured to execute program code stored in the memory unit. 13. The device according to claim 1, additionally containing a patient circuit monitoring unit, configured to monitor the achievement of specified electrical parameters when the patient is connected to the circuit. 14. The device according to claim 1, additionally containing an interface unit. 15. The device according to claim 14, wherein the interface unit contains at least one of: • button, • light indication device, • display, • touch control panel. 16. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses of a smooth shape. 17. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses for which the first minimum value is equal to the second minimum value. 18. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses for which the maximum value module is equal to the sum of the modules of the first minimum value and the second minimum value. 19. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses in which, on a graph of changes in pulse amplitude over time, the area under the part of the graph with positive amplitude values is equal to the area above the part of the graph with negative amplitude values. 20. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the shape of a “Mexican hat” wavelet. 21. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the form of a Daboshi wavelet db4. 22. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the graph of the pulse amplitude over time has the form of a Coiflet wavelet. 23. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the form of a simlet wavelet. 24. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the form of a Morlet wavelet. 25. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses, in which the pulse amplitude graph over time has the form of a Meyer wavelet. 26. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses whose maximum amplitude is in the range of 0.05-10 mA. 27. The device according to claim 1, in which the electrical pulse generation unit is configured to generate single electrical pulses having a pulse duration in the range of 2-100 ms. 28. The device according to claim 1, made with the ability to generate electrical pulses with a frequency of up to 600 pulses per second. 29. The device according to claim 1, made with the ability to connect to • one or more Biofeedback systems (BFB), • mobile device, • computer. 30. The device according to claim 1, in which at least one electrode is configured to be attached to the patient’s scalp. 31. The device according to claim 1, in which at least one electrode is designed to be attached to the patient’s ear. 32. The device according to claim 1, in which at least one electrode is designed to be attached to the patient’s eye area. 33. The device according to claim 1, in which at least one electrode is designed to be attached to the skin of the patient’s head or neck in the region of the vagus nerve. 34. A method of non-invasive electrical stimulation of nervous tissue of the central nervous system, including: generation of at least one electrical pulse, in which the amplitude value of the pulse in time has six sequentially located sections: the first section in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value to zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; And the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value; And stimulation of nervous tissue by a generated impulse through exposure to the skin. 35. The method according to claim 34, in which the generation of at least one electrical pulse is performed by a device having at least two electrodes, a control unit, and an electrical pulse generation unit. 36. The method according to claim 34, in which the method further includes generating electrical pulses with a given at least one of the following parameters: interval between bursts, interval between pulses in a burst, number of pulses in a burst. 37. The method according to claim 34, wherein the method further includes generating a sequence of electrical pulses with intervals between pulses determined by a random law within the specified minimum and maximum interval values. 38. The method of claim 34, wherein generating at least one electrical pulse includes generating multiple electrical pulses and aggregating them by superimposing one another with partial overlap. 39. The method according to claim 34, in which the generated at least one electrical pulse has a smooth graph of the pulse amplitude over time. 40. The method of claim 34, wherein the generated at least one electrical pulse has a first minimum value equal to the second minimum value. 41. The method according to claim 34, in which the generated at least one electrical pulse has such maximum and minimum values of the pulse amplitude that the module of the maximum value is equal to the sum of the modules of the first minimum value and the second minimum value. 42. The method according to claim 34, in which the generated at least one electrical pulse has such a graph of the pulse amplitude over time that the area under the part of the graph with positive amplitude values is equal to the area above the part of the graph with negative amplitude values. 43. The method of claim 34, wherein the generated at least one electrical pulse has a pulse amplitude versus time graph in the form of a Mexican hat wavelet. 44. The method of claim 34, wherein the generated at least one electrical pulse has a pulse amplitude versus time graph having the shape of a Daboshi wavelet db4. 45. The method according to claim 34, in which the generated at least one electrical pulse has a graph of the change in pulse amplitude over time, having the form of a Coiflet wavelet. 46. The method according to claim 34, in which the generated at least one electrical pulse has a graph of the change in pulse amplitude over time, having the form of a wavelet symlet. 47. The method according to claim 34, in which the generated at least one electrical pulse has a graph of the pulse amplitude over time, having the form of a Morlet wavelet. 48. The method of claim 34, wherein the generated at least one electrical pulse has a pulse amplitude versus time graph in the form of a Meyer wavelet. 49. The method according to claim 34, in which the generated at least one electrical pulse has a maximum amplitude value in the range of 0.05-10 mA. 50. The method of claim 34, wherein the generated at least one electrical pulse has a pulse duration in the range of 2-100 ms. 51. The method of claim 34, wherein generating at least one electrical pulse includes generating a plurality of electrical pulses at a frequency of up to 600 pulses per second. 52. The method according to claim 34, in which stimulation of nervous tissue includes a period of increase and a period of termination of stimulation. 53. The method according to claim 52, in which during the period of increasing stimulation, the strength of the electrical current gradually increases, and this period lasts from 10 to 300 s; During the end of stimulation period, the electrical current gradually decreases, and this period lasts from 3 to 15 s. 54. The method according to claim 52, in which during the period of increasing stimulation, the electrical current gradually increases; During the period of termination of stimulation, the current strength of the electrical influence gradually decreases, and the rise period and the end period of stimulation are of equal duration. 55. The method of claim 34, wherein stimulation occurs during a stimulation session lasting from 10 to 60 minutes. 56. The method of claim 34, wherein the stimulation is performed by applying pressure to the patient's scalp. 57. The method of claim 34, wherein stimulation is performed by applying pressure to the skin of the patient's ear. 58. The method according to claim 34, in which the stimulation is performed by acting on the skin in the eye area of the patient. 59. The method according to claim 34, in which stimulation is performed by influencing the skin of the patient’s neck or head in the area of the projection of the vagus nerve. 60. A system for non-invasive electrical stimulation of nervous tissue of the central nervous system, containing: at least two electrodes; Control block; a block for generating electrical pulses, configured to generate single electrical pulses of a predominantly symmetrical shape such that the graph of changes in pulse amplitude over time has six sequentially located sections: the first section in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value of zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value. 61. The system according to claim 60, in which the control unit and the electrical pulse generation unit are connected through at least one wire. 62. The system according to claim 60, in which the control unit and the electrical pulse generation unit are connected via wireless communication. 63. Pop system 60, in which the electrical pulse generation unit is connected to at least two electrodes via at least one wire. 64. The system according to claim 60, in which the electrical impulse generation unit and at least two electrodes are made in a single body of the wearable device. 65. The system according to claim 60, additionally containing at least one additional block from the list: trigger pulse generator, second block for generating electrical impulses, adder, level regulator, voltage-current converter, unit for measuring current and voltage parameters; Patient circuit control unit. 66. The system according to claim 65, in which at least one additional unit is structurally designed in a single housing with the electrical pulse generation unit. 67. The system according to claim 60, in which the control unit contains at least one control element from the list: microcontroller, memory unit, a microprocessor configured to execute program code stored in a memory unit. 68. The system according to claim 67, in which the control unit is at least part of one of: computer, mobile device, biofeedback systems. 69. The system of claim 60, further comprising an interface unit that is at least part of one of: computer, mobile device, biofeedback systems. 70. The system according to claim 69, wherein the interface block contains at least one of: button, light indication device, display, touch control panel. 71. A non-transitory computer-readable medium containing a set of instructions for a processor to control an electrical pulse generator, wherein the set of instructions allows the electrical pulse generator to generate electrical pulses of a predominantly symmetrical shape for non-invasive electrical stimulation of the nervous tissue of the central nervous system, in which the change in the amplitude value of the pulse over time is six in series sections located one after another: the first section in which the amplitude decreases from zero to the first minimum value; a second section in which the amplitude increases from the first minimum value to zero; the third section, in which the amplitude increases from zero to the maximum value; the fourth section, in which the amplitude decreases from the maximum value to zero; the fifth section, in which the amplitude decreases from zero to the second minimum value; And the sixth section, in which the amplitude increases from the second minimum value to zero; wherein the module of the maximum value is greater than the module of the first minimum value and the module of the second minimum value. 72. A device for non-invasive electrical stimulation of nervous tissue of the central nervous system, containing: at least two electrodes; Control block; an electrical pulse generation unit configured to generate single electrical pulses such that the graph of changes in the pulse amplitude over time has the form of the second derivative of the Gaussian function. 73. A method of non-invasive electrical stimulation of nervous tissue of the central nervous system, including: generation of at least one electrical pulse, in which the amplitude value of the pulse in time has the form of the second derivative of the Gaussian function and stimulation of nervous tissue by a generated impulse through exposure to the skin.