RU2778009C1 - Non-invasive electrode matrix of spinal neuroprosthesis and method for its application - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine, namely to a non-invasive electrode matrix for multisegment stimulation of the spinal cord, and the method for its application. The electrode matrix contains a frame with guides (1), two replaceable modules, two bases of replaceable modules. The frame with guides is designed to fit the patient’s back snugly. Telescopic electrode holders for spinal cord stimulation are installed in each of the replaceable modules. In this case, the electrodes are fixed at the ends of the telescopic holders directed to the patient’s back and are removable. The bases of the replaceable modules are made with the possibility of moving along the frame guides and fixing on the frame guides in a given position. Each of the replaceable modules is placed in the corresponding base. One of the telescopic holders (11) is fixed, and the others are movable (12) and have the possibility of longitudinal and vertical movement relative to the replaceable module in which they are installed, so that the electrodes are in contact with the patient’s skin. A non-invasive electrode matrix using percutaneous electrical stimulation of the spinal cord is used for the rehabilitation of the patient’s motor functions, for the modulation of the functions of the patient’s internal organs, for the diagnosis of the functional state of the patient's autonomic nervous system, for the relief of spastic syndrome caused by a violation of the segmental apparatus of the spinal cord.

EFFECT: due to the design features of the electrode matrix for percutaneous multisegment stimulating electrical action, it is possible to repeat the individual features of the patient’s back shape during the rehabilitation session, including during movements, as well as to increase the wear resistance of the matrix.

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Description

The field of technology to which the invention belongs

The invention relates to medicine, in particular to neurophysiology, and can be used in neurology, traumatology and orthopedics in the rehabilitation of patients after diseases and/or traumatic injuries of the brain and/or spinal cord, resulting in impaired walking function. The invention can also be used for the treatment of pathology of the organs of the respiratory system, the cardiovascular system and the therapy of the functions of other internal organs of a person.

Background of the invention

Currently, there are non-invasive (not requiring surgical intervention) methods of spinal cord stimulation that make it possible to facilitate voluntary walking, as well as to restore and ensure independent movement of patients with walking disorders caused by diseases and / or traumatic injuries of the brain and / or spinal cord, and allow to restore the motor functions of the upper and lower limbs of patients.

For example, there is a method for regulating and restoring independent walking in patients with motor pathologies of various origins (RU2725090 C1). The method includes simultaneous continuous stimulation of the spinal cord at least at the level of the T11-T12 vertebrae and rhythmic stimulation of the spinal cord roots at the level of the T11 and L1 vertebrae, in which the level of stimulation and lateralization of stimulation depends on the phase and speed of movement of the unaffected upper and/or lower limb. In this case, the inclusion of rhythmic stimulation of the roots of the spinal cord is carried out due to the movement of the unaffected upper and/or lower limb.

Non-invasive electrical stimulation of spinal cord regions is also used in patients with disorders of the musculoskeletal system as part of the use of an active exoskeleton (RU2016144450 A). In this case, cutaneous electrical stimulation is carried out in the region of the thoracic vertebrae T11, T12, depending on a certain phase of the movement of the active exoskeleton.

Also, the existing level of technology uses cutaneous electrical stimulation in the process of controlling breathing in patients with acute respiratory failure in diseases of viral or bacterial origin (RU2750236 C1). Electrical stimulation is used to activate the intercostal muscles, diaphragm, abdominal muscles by stimulating the roots of the spinal cord and segments of the thoracic spinal cord with different impulse parameters for each type of muscle. The methods listed above and other known methods of transcutaneous electrical stimulation make it possible to influence the spinal cord in several segments simultaneously. To implement the possibility of simultaneous stimulation of the spinal cord in several different departments according to various selected algorithms, independent electrodes or electrode systems are used.

So, to implement, for example, the method of cutaneous electrical stimulation of the spinal cord, disclosed in RU2545440 C1, a matrix is used in the form of electrodes placed on an elastic electrically neutral base in three columns and forming horizontal rows of each 3 elements. In this case, the horizontal rows of electrodes can move and be fixed in the longitudinal direction. The electrodes are made in the form of soft cups, which are filled with conductive electrode gel. The electrodes are attached to the elastic base substrate by a springy rigid base, through which an electrical conductor is passed, connected to the electric stimulus shaper. For stimulation, the electrode matrix is placed skin over the patient's spine so that the central electrodes in triplets are located between the spinous processes above the spinal cord, and the extreme electrodes are symmetrically to the right and left of the central line of the spine above the roots of the spinal cord. The matrix can be placed above the lumbar enlargement of the spinal cord, where the control center for leg movements is located, or above the cervical enlargement of the spinal cord, where the control center for hand movements is located and which is associated with the underlying lumbar enlargement.

The design of such a matrix has several disadvantages. Firstly, the design of the electrodes themselves leads to their rapid wear and tear. Secondly, the rigid base of the electrode does not allow repeating the individual features of the shape of the human back. This is very inconvenient, as the matrix has to be tightly tied to the patient's torso, which limits the patient's movements during rehabilitation sessions and leaves deep marks on the back from the edges of the matrix.

Thus, in order to overcome the problems described above, there is a need to develop a matrix of electrodes fixed on the back of a patient for percutaneous multisegmental (multilevel) stimulating electrical effects, including during movements, on the structures of the spinal cord according to a certain algorithm.

That is what the present application is about.

Disclosure of the essence of the invention

The aim of the present invention is to overcome the above disadvantages and provide a flexible and multifunctional electrode array that can be used in various applications of electrical spinal cord stimulation that require multisegmental stimulation of the spinal cord.

The technical result achieved in the implementation of the invention is the development of an electrode matrix fixed on the patient's back, above the spine, for a multi-segmental (multi-level) stimulating electrical effect on the structures of the spinal cord in the range of segments of the spinal cord T1-S1

The technical result of the invention is achieved due to the fact that the non-invasive electrode matrix for multisegmental stimulation of the spinal cord contains a frame with guides, made with the possibility of a snug fit to the back of the patient; at least two replaceable modules with telescopic electrode holders installed in each of them, and the electrodes are fixed on the ends of the telescopic holders directed towards the patient's back, and are removable; at least two replaceable module bases, movable along the frame guides and fixed on the frame guides in a predetermined position; wherein each of the replaceable modules is placed in the corresponding base and one of the telescopic holders is fixed, and the remaining movable telescopic holders are able to move longitudinally and vertically relative to the replaceable module in which they are installed, so that the electrodes are in contact with the patient's skin.

In some embodiments of the invention, the frame is made in the form of two parallel fastened elements having a curved boomerang shape, between which two guides are located, each of which passes through holes in both elements in the bend area.

In some embodiments of the invention, at both ends of each of the elements, supports are fixed through swivel joints.

In private embodiments of the invention, the supports have a medical grade silicone backing for a snug fit to the patient's body.

In particular embodiments of the invention, the parallel elements of the frame have holes for attaching means for attaching the matrix of electrodes to the patient's body, selected from: belt, brace, elastic belts.

In private embodiments of the invention, each plug-in module is fixed in the base of the plug-in module by means of spring-loaded snap buttons located on each side of the plug-in module.

In some embodiments of the invention, at least three telescopic electrode holders are installed in each of the replaceable modules.

In some embodiments, the removable electrode is a round button electrode with a conductive adhesive layer.

Another technical result of the present invention is the use of a non-invasive electrode matrix using transcutaneous electrical stimulation of the spinal cord for the rehabilitation of the patient's motor functions and/or for modulating the respiratory, cardiovascular or other functions of the patient's internal organs and/or for diagnosing the functional state of the patient's autonomic nervous system and/or for the relief of spastic syndrome caused by a violation of the segmental apparatus of the spinal cord.

Brief description of the drawings

The accompanying drawings, which are incorporated within and form part of this specification, illustrate embodiments of the invention and, together with the above general description of the invention and the following detailed description of the embodiments, serve to explain the principles of the present invention. In the drawings, the same positions are used to designate the same parts or structural elements.

In FIG. 1 shows a top view of the array of electrodes.

In FIG. 2 is a side view of the electrode array.

In FIG. 3 is a view of the electrode matrix, which shows in more detail the mounting of the electrodes on the replaceable modules.

In FIG. 4 is a view of the matrix from the side that is in contact with the patient's back.

In FIG. 5 shows the matrix on the back of the patient, connected to an external electrical stimulator during the study.

In FIG. 6 shows the layout of the electrodes.

In FIG. 7 shows one embodiment of a protective frame-overlay for protecting protruding elements from the electrode array.

In FIG. 8 shows the relative changes (%) of the kinematic characteristics of the patient's walking after the rehabilitation procedure in Patient 1. Testing when walking on a treadmill. A - the duration of the step cycle, B - the duration of the support period from the paretic side, C - the duration of the support on one leg from the paretic side, D - the length of the step cycle, E - walking speed, E - the height of the foot lift from the paretic side, F, H, I - flexion / extension amplitude in the hip, knee, ankle joints, respectively, from the paretic side, K, L, M and N - EMG amplitude of the anterior tibial muscle, lateral head of the gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle, respectively, c paretic side.

In FIG. 9 shows the relative changes (%) of the kinematic characteristics of the patient's walking after the rehabilitation procedure in Patient 2. Testing when walking on the floor. Other designations as in Fig. 7

Notation

In the figures, the elements are indicated by the following positions:

1 - support "boomerang",

2 - replaceable module,

3 - base of the replaceable module,

4 - support,

5 - swivel,

6 - place for fastening belts or belts,

7 - guide,

8 - handle for moving the base of the replaceable module,

9 - handle fixing the position of the module base,

10 - button-latch of the replaceable module,

11 - telescopic electrode holder fixed in the module,

12 - telescopic electrode holder with the ability to move in the module,

13 - handle-lock of the longitudinal position of the electrode holder,

14 - electrode holder rod,

15 - slot in the replaceable module for the free movement of the electrode holder,

16 - replaceable button electrodes,

17 - conductors to the stimulator.

18 - electrode array assembly,

19 - belt,

20 - external electrostimulator of the neuroprosthesis,

21 - vertebra T11,

22 - vertebra T12,

23 - vertebra L1,

24 - vertebra L2,

25 - electrode above the spinal cord,

26, 27 - electrodes over the roots of the spinal cord,

28 - cover.

Terms and Definitions

Some of the terms used in this specification are defined below. Unless otherwise defined, the technical and scientific terms in this application have the standard meanings generally accepted in the scientific and technical literature.

As used herein and in the claims, the terms "comprises", "comprising" and "includes", "having", "provided", "comprising" and their other grammatical forms are not intended to be construed in an exclusive sense, but, on the contrary, are used in a non-exclusive sense (i.e., in the sense of "having in its composition"). As an exhaustive list, only expressions like "consisting of" should be considered.

Under the "regulation of walking", "control of walking" refers to the management of the characteristics of walking as a whole (speed, step amplitude, duration), and its components, for example, the phases of the stepping cycle (transfer, support).

By "facilitating walking" is meant a special case of regulation of walking, when the control of the characteristics of walking leads to improved coordination, increased gait stability and walking speed.

The term "stimulation" refers to the electrical action of alternating current, while "continuous stimulation" refers to stimulation, the beginning and end of which do not depend on the rhythmic movements of intact (not affected by the pathological process that caused hemiplegia) arms and legs; "intermittent (rhythmic) stimulation" refers to stimulation, the beginning and end of which are synchronized with the rhythmic movements of intact arms and legs, while "spatial-selective stimulation" refers to intermittent (rhythmic) stimulation, in which the level of stimulation and lateralization (right or left ) stimulations depend on the phase of movements of the intact arms and legs, by "spatio-temporal stimulation" is meant space-selective stimulation, in which the beginning and end of this stimulation depends on the phase of movements of the intact arms and legs.

The term "multi-segmental stimulation" refers to an effect on the spinal cord, meaning an effect on the level of two or more segments of the spinal cord.

In addition, the terms "first", "second", "third", etc. are used simply as conditional markers, without imposing any numerical or other restrictions on enumerable objects.

The term "connected" means functionally connected, and any number or combination of intermediate elements between connected components (including the absence of intermediate elements) can be used.

Detailed description of the invention

The present invention is directed to the development of an electrode matrix fixed in the region of the patient's spine, with the help of which it is possible to perform transcutaneous stimulation of the spinal cord.

The scheme of the electrode matrix (hereinafter referred to as the matrix) assembly is shown in Fig. 1. The matrix consists of a frame, at least two replaceable modules (2) with electrodes attached to each module and corresponding at least two bases (3) of replaceable modules installed on the matrix guide frames.

The frame consists of two parallel elements (1), which are fastened with cylindrical guides (7). The matrix frame is made of light alloy materials to ensure strength and minimize weight and acts as a support-guide for the bases (3) of the replaceable modules and directly for the replaceable modules themselves (2).

The frame of the matrix has a generally rectangular shape. Two parallel elements (1) are identical, and each of them can be made as a U-shaped part or a boomerang-shaped part (hereinafter referred to as boomerang supports), or a part having any other curved shape, in which the ends of the part on both sides are raised to a certain height in relation to the main part.

Between the parallel elements (1) there are two cylindrical guides (7) passing through the holes in both elements (1) in the bend area. The bases (3) of the replaceable electrode modules move along the guides (7).

Supports (4) are attached to the frame. In particular, two supports (4) are fixed to each of the parallel elements (1) by means of a swivel joint (5). The four supports (4) included in the matrix have a substrate made of medical silicone for the most dense non-traumatic fit to the patient's body, in particular, to the patient's back. The supports (4) of the matrix are self-adjusting (when the matrix is applied to the back of the patient, the supports occupy the only possible position when they are tightly pressed against the back) due to the swivel (5) and ensure reliable positioning of the matrix on the patient's body. In a preferred embodiment of the invention, the free angular movement of the swivel (5) can be within a solid angle of 15 arc. degrees. Each of the boomerang supports (1), which is part of the frame, has holes (6) at the corners, which are intended for fastening a belt or belts that attract the matrix to the patient's body. Element (1) may have any other shape that raises the belt or belt attachment points above the overall frame structure.

The bases (3) of plug-in modules can be moved along the rails (7) using the handles (8) and fixed on the rails using the clamps (9). In the depicted embodiment of the invention in FIG. 1 latch is a mechanical clamp based on an eccentric cam, which, due to friction forces arising at the point of contact between the cam and the guide, holds the bases of the modules in a given position. When you press the latches (9), the surface of the latches disengages from the guide groove and allows you to move the bases (3) of the replaceable modules along the guides (7).

In the bases (3) of the replaceable modules, the replaceable modules (2) are placed, fixing them there with the help of at least four latches (10). The snap buttons (10) of the replaceable modules are spring-loaded and allow you to quickly replace the modules (2) in the bases (3) when the matrix is on the patient (if necessary, for example, change the button electrode). Electrodes are attached to each replaceable module (2). Module (2) with electrodes is inserted into the matrix frame. If the electrode turned out to be of poor quality, which became clear after stimulation was started, then it is necessary to remove the module (2) from the matrix and replace the electrode.

To hold and position the electrodes on the patient's body, each of the replaceable modules contains at least three telescopic electrode holders (11, 12). The locking handle (13) of the telescopic electrode holder fixes the longitudinal position of the telescopic holder relative to the replaceable module (2). The rod (14) of the telescopic electrode holder has an indicator of the electrode immersion depth under the replaceable module (2) and can be used to control the electrode pressing against the patient's body when installing the matrix.

One of the telescopic electrode holders (11) is fixed within one of the replaceable modules (2). According to the depicted embodiment of the invention in FIG. 1-5, the stationary telescopic electrode holder (11) is central in the upper exchangeable module (2), representing the "zero coordinate". The fixed telescopic electrode holder (11) is placed, for example, in the case of using an electrode matrix for the regulation of motor activity, between the vertebrae T11-T12, above the spinal cord. The matrix is fixed and the positions of all other electrodes are adjusted to the anatomical features of the patient, changing their longitudinal position relative to each other and each of the replaceable modules (2) and changing their depth to control pressing against the patient's body. In this case, the electrode matrix can be fixed anywhere above the spine within the back (thoracic and lumbar spine/spinal cord), depending on its application.

The remaining five telescopic electrode holders (12), according to the preferred embodiment of the invention, can be moved along the replaceable module within the guide slots (15). This movement allows you to accurately position the electrodes, taking into account the individual anatomical features of the patient.

Each of the telescopic holders (11, 12) of the electrodes at the end facing the patient's back has a push-button attachment for fixing removable electrodes with a mating push-button connector (16) (figure 4). The holders connect the electrodes to the stimulator with conductors (17) (the conductor is partially shown schematically in Fig. 4).

Each electrode used in the matrix is a round button electrode, 1.5 cm - 2.5 cm (or 0.5 inch - 1 inch) in diameter, with a conductive adhesive layer. As a non-limiting example, for example, disposable ECG recording electrodes or round reusable stimulation electrodes of the Beurer 66102 type can be used.

The matrix assembly process before use is as follows.

1. Attach the trigger electrodes (16) to the telescopic electrode holders (11, 12).

2. Replaceable modules (2) are installed in the bases of the replaceable modules (3) so that the module with the fixed electrode holder (11) is in the upper base of the replaceable module (as in Fig. 1, 2, 4). After that, the replaceable modules are fixed using snap buttons (10).

The location of the assembled matrix (18) on the patient is shown in Fig.5. Near the matrix, on the straps, there is an external stimulator of the neuroprosthesis (20).

A possible order of electrode positioning in the case of a non-limiting example of the use of an electrode array for restoring motor activity is presented below.

1. Fix the stationary telescopic electrode holder (11) in the selected position, for example between the vertebrae T11-T12.

2. Movable telescopic electrode holders (12) of the upper replaceable module (2) are placed above the roots of the spinal cord between the vertebrae T11-T12 and fixed with locking handles (13).

3. Movable telescopic electrode holders (12) of the lower replaceable module (2) are placed between the vertebrae L1-L2 and above the roots of the spinal cord between the vertebrae L1-L2 and fixed with locking handles (13).

4. The matrix is drawn to the back of the patient and adjusted into place with a belt, brace, elastic straps, etc. (19).

Having fixed the matrix on the patient's back, additional adjustment of the position of each of the electrodes (12) can be carried out by loosening the handle-lock of the electrode (13), moving it within the slot (15). Using the rod of the telescopic electrode holder (14), the electrode can be temporarily pulled away from the patient's body when necessary (for example, put a conductive gel under the electrode if the skin resistance is high). The rod of the electrode holder (14) and slots (15) have scales. This allows you to document the location of each of the electrodes on the patient's body and, when reusing the matrix on the patient, reproduce the coordinates of the location of the electrodes, preparing the matrix for the procedure, which will reduce the duration of the preparation of the matrix for stimulation with the participation of the patient and save the patient's physical resources for the rehabilitation procedure.

In some embodiments of the invention, when the electrode array is used for severe patients who cannot stand and/or walk independently, the matrix is provided with a cover (28) in order to protect the protruding elements from the straps of the suspension system to which the patient is attached in some walking simulators. . The cover is attached to the protective frame-plate, which is attached to the frame of the electrode matrix. One of the non-limiting examples of the protection frame lining is shown in Fig. 7. The cover (28) consists of four parallel cylindrical axes attached orthogonally to two parallel plates which have connecting grooves. These grooves are included in the fastening with the bushings of the matrix base and carry out its correct spatial arrangement and mating with the matrix base. The fixation of the lid is carried out by the elements of the patient support suspension system by pressing the lid to the base of the matrix.

The matrix can be used in all cases when non-invasive stimulation of the spinal cord and spinal cord roots is required at several levels in the range of T1-S1 spinal cord segments, including when the beginning and end of stimulation must be coordinated with a certain event (the beginning of limb movement, the beginning signal recording by an external recording device). The matrix can be fixed anywhere above the spine within the back (thoracic and lumbar spine/spinal cord).

Use of a matrix for spinal cord stimulation.

For example, the electrode matrix proposed in the present invention can be used for the rehabilitation of a patient by restoring movements as part of an exoskeleton, when transcutaneous electrical stimulation of the spinal cord is performed at several levels of the spinal cord, depending on a certain phase of movement of the active exoskeleton or the patient's legs. Thus, electrical stimulation of the spinal cord is carried out in the region of the thoracic vertebrae T11, T12, depending on a certain phase of the movement of the active exoskeleton. In one of the phases of movement of the active exoskeleton, the fixed telescopic electrode holder (11) of the matrix can be located at the level of T11-T12. In this case, if, for example, it is necessary to restore the function of maintaining the vertical post, then the fixed telescopic holder of the matrix electrode (11) can be located between L1-L2, and the remaining matrix electrodes are moved within each replaceable matrix module and the replaceable matrix modules are moved apart in this way to stimulate the roots of the spinal cord at the L1-L2 level on the right or left if the patient begins to fall to the right or left.

The phase of movement is determined using sensors for determining the current position of the constituent elements of the exoskeleton. An example of such an exoskeleton can be, for example, the exoskeleton disclosed in RU2016144450 A. At the same time, there are possible solutions when transcutaneous stimulation in the exoskeleton depends on a certain phase of the patient's legs movement, and when the phases of leg movement are determined by sensors located on the legs (RU 2020101607 BUT).

Another alternative application of the electrode matrix is its use in the system to maintain respiratory function. Technical solutions are known in the prior art that allow neurostimulation of patients connected to ventilators (for example, RU2750236 C1). Electrical stimulation is used to activate the intercostal muscles, diaphragm, abdominal muscles by stimulating the roots of the spinal cord and segments of the thoracic spinal cord with different impulse parameters for each type of muscle. In this case, the matrix can be located as follows: the fixed telescopic electrode holder (11) of the matrix is fixed between the vertebrae T3-T4, or T4-T5, or T5-T6, or T6-T7, or T7-T8, and the remaining electrodes are located at the level higher or lower depending on which function (inhale or exhale) you want to activate first. Inhale - levels are higher, exhale - levels are lower.

Also, the electrode matrix can be used for simultaneous impact on two or more human physiological systems, the centers of regulation of which are located in the spinal cord. Thus, the problem of a sharp decrease in blood pressure during the verticalization of patients with spinal cord injury (orthostatic hypotension) is known. Stimulation at the level of the lumbar thickening, depending on the phases of movement, will provide a transition from a sitting position to a standing position and a stable vertical posture in such patients (Sayenko D. G. et al. Self-assisted standing enabled by non-invasive spinal stimulation after spinal cord injury //Journal of neurotrauma. - 2019. - T. 36. - No. 9. - S. 1435-1450), and stimulation in the midthoracic spine will prevent a sharp drop in blood pressure and syncope (Phillips A. A. et al. An autonomic neuroprosthesis: noninvasive electrical spinal cord stimulation restores autonomic cardiovascular function in individuals with spinal cord injury // Journal of neurotrauma. - 2018. - V. 35. - No. 3. - P. 446-451). To regulate the functions of the cardiovascular system to prevent syncope during the verticalization of spinal patients, the fixed telescopic electrode holder (11) of the matrix can be fixed at the T7 level. If another cardiological problem is being solved (for example, arrhythmia), then the fixed telescopic electrode holder (11) of the matrix can be located at the T1 or T5 level.

The matrix can be used in diagnosing the functional state of the autonomic nervous system, when the spinal cord is stimulated with an electric current and evoked skin autonomic potentials are recorded from electrodes located in those segments of the spinal cord in which the centers of regulation of one or another autonomic system are located. One of such methods for diagnosing the autonomic nervous system is disclosed in RU2201710 C1. To do this, autonomic cutaneous evoked potentials are recorded from electrodes located along paravertebral lines on both sides of the line of spinous processes in the intercostal spaces at the level of the T6-T11 vertebrae or lower at the level of T12-S1.

Damage to the sympathetic trunk is diagnosed with an increase in the amplitude of the potential, a decrease in the conduction velocity and a decrease in the latent period of the potential relative to the norm. Damage to the spinal roots is diagnosed with an increase in the latent period of the potential, a decrease in the speed of conduction and a decrease in the amplitude of the potential. A complete violation of the conduction of the segmental nerve is diagnosed in the absence of an evoked skin potential at the level under study.

Since the prior art has shown that the mechanisms of action on the spinal cord during epidural and transcutaneous electrical stimulation are the same (Gerasimenko et al., Transcutaneous electrical spinal-cord stimulation in humans. // Ann. Phys. Rehabil. Med. - 2015. - V. 58, N4. - P. 225-231), the electrode matrix can be used in cases where invasive (epidural) electrical stimulation of the spinal cord is currently used at several levels. For example, the matrix can be used to relieve spastic syndrome caused by a violation of the segmental apparatus of the spinal cord in accordance with RU2038099 C1. To do this, the fixed telescopic electrode holder (11) of the matrix can be fixed at the level of the vertebrae T12-L1. This method includes dosed administration of drugs into the epidural space at the level of the lumbar enlargement and stimulation of the spinal cord above and below the lumbar enlargement.

The following is a non-limiting example of an electrode array according to the present invention for restoring locomotor functions of a patient.

Example. The use of the matrix in the rehabilitation of motor functions.

The purpose of motor rehabilitation using the matrix as part of the neuroprosthesis (RU2725090) is to improve walking skills, increase mobility in the joints of the lower extremities, and improve coordination.

A rehabilitation procedure using a matrix as part of a neuroprosthesis can consist of two parts: training on a treadmill and training on a fixed, flat, hard surface (for example, walking on the floor). Each part of the procedure can be approximately the same duration. The total duration of the workout is from 20 to 60 minutes. The duration depends on the general fitness / fatigue, the patient's well-being (load level - moderate). The duration of training for each patient can increase from the beginning of the rehabilitation period to its end. During the procedure, the patient can use the technical means of rehabilitation familiar to him (orthoses, canes, walkers, crutches, etc.). Perhaps 12 procedures per rehabilitation course. Possible modes: 20 minutes for the first 1-3 procedures, an increase in duration of 30 minutes for 4-6 procedures and up to 40-60 minutes for 7-12 procedures. After a 1-2 day break between treatments, the duration of the workout can be reduced.

Before the start of training, a matrix of electrodes is placed on the skin, above the spine (figure 5). Disposable or individual for each patient electrodes with a conductive self-adhesive surface with a push-button connector are used.

Using the capabilities of the matrix to adjust the position of the electrodes, taking into account the anatomical features of the patient, the electrodes are positioned and fixed as follows (Fig. 6):

• along the vertical axial line of the spine between the vertebrae T11 (21) and T12 (22) - an electrode (25) connected to a fixed telescopic electrode holder (11),

• 1-3 cm laterally from the affected side and down from the intervertebral zone between the vertebrae T11 (21) and T12 (22) - an electrode (26) connected to a movable telescopic electrode holder (12),

• 1-3 cm laterally from the affected side and down from the intervertebral zone between the vertebrae L1 (23) and L2 (24) - an electrode (27) connected to a movable telescopic electrode holder (12).

As a result, electrode (25) should be located above the spinal cord, electrodes (26) and (27) - above the dorsal roots of the spinal cord. The electrodes on the back are the cathodes. Two anodes are placed above the iliac crests on the right and left, or one anode is placed on the affected side above the iliac crest. Anodes are common to all cathodes.

After the array of electrodes is installed, they are connected to the transcutaneous electrical stimulation stimulator (20) using wires (17).

The intensity of stimulation depends on the excitability of the spinal neural networks of the spinal cord and on the level of pain sensitivity of the patient. The selection of the intensity of stimulation is carried out by the specialist conducting the procedure immediately after the start of the training (the patient walks on the floor or on the treadmill at a comfortable speed). The intensity of the current at the chosen frequency of stimulation should be at the level of parasthesia (sensation of tingling, or burning, or mild soreness, or heaviness in the cathode area). Or the intensity is 5-10% less than the intensity of parasthesia. The intensity of stimulation in motion should not cause discomfort or pain. During training, a gradual increase in stimulation intensity is possible as the patient adapts to walking and the current stimulation intensity. These values of the current intensity should be in the range of currents that cause motor responses of the muscles of the lower extremities to single rectangular pulses with a duration of 1 ms, which are determined before the start of the rehabilitation course.

Stimulation frequency at the level of T11-T12 vertebrae, electrode (25) - about 30 Hz. The frequency of stimulation at the level of the roots of the spinal cord in the region of the vertebra T12, the electrode (26) is about 40 Hz, in the region of the vertebra L2, the electrode (27) is about 15 Hz.

The pulse shape is bipolar, filled with a frequency of ~5-10 kHz, or monopolar, filled with a frequency of ~5-10 kHz.

During training, the current intensity on the electrodes (26) and (27) is zero if the patient is standing. When walking, the stimulator channels connected to these electrodes turn on. The lateral electrode (26) in the region of the T12 vertebra receives current in the transfer phase of the affected leg, or in the stance phase of a conditionally healthy leg, or during reliance on a technical rehabilitation device (cane, crutch, etc.), which the patient holds in conditionally healthy hand. On the lateral electrode (27) in the area of the L2 vertebra - in the support phase of the affected leg, or in the phase of transfer of a conditionally healthy leg, or separation from the support of the technical rehabilitation means. The signal about the phase of the step and about the support/transfer of the technical rehabilitation device is received by the stimulator from motion sensors, which are fixed on the patient’s legs and/or on the technical rehabilitation device before the procedure (RU2725090; Grishin A.A., Bobrova E.V., Reshetnikova V. V., Moshonkina T.R., Gerasimenko Y.P. A system for detecting the phases of the stepping cycle and spinal cord stimulation as a tool for controlling human locomotion // Medical Technology - 2020. - No. 5. - pp. 10-14.)

Rehabilitation procedures are carried out in the presence of a specialist. The specialist monitors the quality of the patient's walking, gives the patient recommendations for adjusting movements in order to increase walking stability, the specialist reduces or increases the speed of the treadmill. Treadmill training with partial body weight support (up to 50%) is possible.

The patient can independently use the neuroprosthesis after the specialist sets and fixes the positions of the electrodes on the matrix and selects the optimal stimulation intensity for the patient and the operating mode of the neuroprosthesis, teaches the patient or his relatives how to operate the neuroprosthesis.

Clinical Cases

Patient 1. 78 years old, male, consequences of acute cerebrovascular accident in the right middle cerebral artery 1 year of rehabilitation. Left-sided hemiparesis. Left-sided hemihypoesthesia.

A rehabilitation procedure was performed using a neuroprosthesis aimed at restoring the function of walking. Cathodes (∅ 2 cm) were fixed along the midline of the spine between T11-T12 vertebrae, to the left and below by ~2.5 cm from the center of this electrode, above the root of the spinal cord and to the left and below by ~2 cm from the average vertical line between the vertebrae L1 -L2. Anodes measuring 5*10 cm were placed above the iliac crests on the right and left. The patient walked on the treadmill for 25 minutes with 4 rest stops for 1-2 minutes. The speed of the treadmill was chosen so that the patient could independently walk along the moving belt without approaching the front leg of the treadmill and without rolling back. The speed during the procedure was changed so that walking was uniform and comfortable for the patient. The starting comfortable speed was 0.2 m/s (0.74 km/h). While walking with the neuroprosthesis, the speed of the treadmill was increased to 0.3 m/s (0.8 km/h).

The stimulation intensity for all electrodes is ~50-70 mA. Stimulation frequency at the level of T11-T12 vertebrae, along the center line, 30 Hz. The frequency of stimulation at the level of the roots of the spinal cord in the region of the vertebra T11-T12 is 40 Hz, in the region of the vertebra L1-L2 20 Hz.

The results of the procedure were monitored on a treadmill. The patient walked without stimulation along the track at a comfortable speed of ~1 min immediately before and immediately after the end of the rehabilitation procedure. The activity of the leg muscles and the kinematic characteristics of walking were recorded using the Stedis complex (Neurosoft LLC). Before the start of the first study, 5 sensors were installed on the patient's body on elastic bands, which include accelerometers that record the movement in space of the body parts on which they are attached, as well as biological signal amplifiers for recording the electrical activity of muscles (electromyograms, EMG). Sensors were installed on the back, in the lumbar region, and also bilaterally on the lower leg and thigh. The EMG of the following muscles was recorded: mm. tibialis anterior, gastrocnemius lateralis, quadriceps femoris (rectus femoris), biceps femoris (long and short heads). To do this, disposable surface electrodes with an adhesive layer ∅ 35 mm (Kendall, H135) were attached to the listed muscles.

The absolute values of the measured parameters before and after one rehabilitation procedure are presented in Table 1. Relative changes are shown in Fig. 8, where 100% correspond to the value of the parameter before the rehabilitation procedure.

After the procedure, the patient's walking speed increased by 8% (Fig. 8, E), which also manifested itself in a decrease in the duration of the step cycle by 6% (Fig. 8, A). The length of the double step increased by 6% (Fig. 8d). With an increase in walking speed, the activity of all recorded muscles decreased markedly (from 3% to 47%, Fig. 8K-H), which demonstrates a decrease in the metabolic cost of locomotion and demonstrates that the rehabilitation procedure optimized the neural regulation of leg muscles.

Patient 2. 68 years old, male, Consequences of cerebral infarction in the territory of the right middle cerebral artery, which occurred 8 months before the procedure. Atherosclerosis of the brachiocephalic arteries with stenosis, 30% carotid bifurcation on the right. S-shaped tortuosity of both internal carotid arteries. Left-sided hemiparesis. Left-sided hemihypoesthesia. Vestibulo-atactic and asthenic syndromes. Background disease: Hypertensive disease of the 3rd degree.

A rehabilitation procedure was performed using a neuroprosthesis aimed at restoring the function of walking. The location of the stimulating electrodes and the stimulation mode are the same as for Patient 1. The duration of walking on the treadmill with stimulation is 20 minutes at a speed of 0.4 m/s (1.41 km/h).

Walking parameters were controlled on a hard surface, on the floor - the patient walked without stimulation in the room where the rehabilitation was carried out, immediately before and immediately after the end of the procedure. The patient had to walk at a comfortable speed for ~1 min, the distance traveled was ~30 m in both cases. The activity of the leg muscles and the kinematic characteristics of walking were recorded in the same way as in the case of patient 1.

The absolute values of the measured parameters before and after one rehabilitation procedure are presented in Table 1, relative changes - in Fig.8.

After the procedure, the patient's walking speed increased by 10% (Fig. 9, E), which also manifested itself in a decrease in the duration of the step cycle by 7% (Fig. 9, A). The length of the double step increased by 6% (Fig. 9, D). Increased range of motion in the hip and knee joints on the affected side (Fig. 9, G, H).

P1, P2 - patients, L - left, P - right, TGB - hip joint, KLN - knee joint, GLN - ankle joint, TA - m. tibialis anterior (anterior tibial muscle), GL - m. gastrocnemius lateralis (lateral head of the gastrocnemius muscle), RF - m. rectus femoris (rectus femoris), BF - m. biceps femoris (biceps femoris).

Thus, it has been shown that the use of an electrode matrix according to the present invention provides reliable and accurate fixation of a set of electrodes on the back of a patient for stimulating the spinal cord and spinal cord roots, as well as the implementation of transcutaneous multisegmental (multilevel) electrical stimulation of the spinal cord structures during movements according to a certain algorithm.

While the invention has been described with reference to the disclosed embodiments, it should be apparent to those skilled in the art that the specific detailed studies are provided for the purpose of illustrating the present invention only and should not be construed as limiting the scope of the invention in any way. It should be clear that it is possible to carry out various modifications without departing from the essence of the present invention.

Table 1

leg P1 P2 track floor Before After Before After Step cycle, s L 1.8 1.7 1.5 1.4 P 1.8 1.7 1.5 1.4 Support period, % of step cycle L 71.6 72.5 65.7 63.8 P 69.9 72.1 68.2 67.2 Single support, % of step cycle L 31.1 27.7 31.9 32.4 P 29.6 25.9 34.2 35.3 Step cycle length, cm 36 38 105 111 Walking speed, km/h 0.74 0.8 2.56 2.82 Foot lift height, cm L 12 7 12 12 P fifteen ten eleven 13 TZB, flexion/extension amplitude, deg. L 27 eighteen 31 33 P 31 22 40 41 KLN, flexion/extension amplitude, deg. L 46 32 44 47 P 52 45 53 52 GLN, flexion/extension amplitude, deg. L eleven 13 27 25 P 12 fifteen 31 33 TA, EMG amplitude, μV L 99 52 120 123 P 33 29 204 201 GL, EMG amplitude, μV L 55 43 125 140 P 67 38 141 145 RF, EMG amplitude, µV L 36 35 45 44 P 52 43 55 60 BF, EMG amplitude, μV L 34 22 80 59 P 69 59 64 61

Claims (17)

1. Non-invasive electrode matrix for multisegmental stimulation of the spinal cord, containing: a frame with guides, made with the possibility of a snug fit to the back of the patient, at least two replaceable modules with telescopic holders of electrodes for spinal cord stimulation installed in each of them, moreover, these electrodes are fixed on the ends of the telescopic holders directed towards the back of the patient and are removable, at least two bases of replaceable modules, made with the possibility of moving along the frame guides and fixing on the frame guides in a predetermined position, and each of the replaceable modules is placed in the corresponding base, one of the telescopic holders is fixed, and the rest of the movable telescopic holders are able to move longitudinally and vertically relative to the replaceable module in which they are installed, so that the electrodes are in contact with the patient's skin. 2. Non-invasive electrode array according to claim 1, in which the frame is made in the form of two parallel fastened elements having a curved boomerang shape, between which two guides are located, each of which passes through holes in both elements in the bending area. 3. Non-invasive electrode array according to claim 2, in which supports are fixed at both ends of each of the elements through swivel joints. 4. Non-invasive electrode array according to claim 3, in which the supports have a substrate of medical silicone for a snug fit to the patient's body. 5. Non-invasive electrode array according to claim 2, in which the parallel frame elements have holes for attaching means for attaching the electrode array to the patient's body, selected from the following: belt, brace, elastic belts. 6. The non-invasive electrode array of claim. 1, in which each plug-in module is fixed in the base of the plug-in module by means of spring-loaded snap buttons located on each side of the plug-in module. 7. The non-invasive electrode array of claim 1, wherein each of the interchangeable modules has at least three telescopic electrode holders. 8. Non-invasive electrode array according to claim 1, in which the replaceable module has slots for placement, longitudinal movement along them of movable telescopic electrode holders and vertical movement of movable telescopic electrode holders relative to them. 9. Non-invasive electrode array according to claim 1, in which each telescopic holder has a locking handle for fixing the longitudinal position of the holder relative to the replaceable module and a rod for regulating the vertical movement of the holder relative to the replaceable module. 10. Non-invasive electrode array according to claim 1, in which a push-button attachment is made at the ends of the telescopic electrode holders for fixing removable electrodes with a reciprocal push-button connector. 11. Non-invasive electrode array according to claim 1, in which the removable electrode is a round button electrode with a conductive adhesive layer. 12. The use of a non-invasive electrode matrix according to claim 1 using transcutaneous electrical spinal cord stimulation for the rehabilitation of the patient's motor functions, and / or for modulating the functions of the patient's internal organs, and / or for diagnosing the functional state of the patient's autonomic nervous system, and / or for relief spastic syndrome caused by a violation of the segmental apparatus of the spinal cord.

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