专利摘要:
The invention relates to medicine and medical technology, particularly neurology, and even more particularly to a device for the non-invasive stimulation of the spinal cord, intended for carrying out diagnostic tests and for performing physiotherapy in medical treatment facilities, general health facilities and research hospitals or in domestic settings. An electrical spinal cord stimulator comprises five stimulation channels with an electrode system, each of which channels includes, connected in series, a voltage converter, a current generator and an output signal generator and is adapted for generating rhythmic modulated bipolar rectangular pulses, rhythmic unipolar rectangular pulses and rhythmic or isolated non-modulated unipolar rectangular pulses, with a stimulation frequency in a range of 1-99 Hz, a current amplitude of from 1 to 300 mA and a modulation frequency of from 4 to 10 kHz. The inputs of each of the channels are coupled to a microcontroller, which is connected to a display unit, control members and a radio module, wherein the microcontroller is designed to be capable of triggering at least one stimulation channel, selecting a trigger mode independently for each of the stimulation channels, and controlling, via each of the stimulation channels, pulse parameters selected from at least the shape of the pulses.
公开号:ES2711200A2
申请号:ES201890045
申请日:2016-11-29
公开日:2019-04-30
发明作者:Yuri Petrovich Gerasimenko;Alexandr Alekseevich Grishin;Tatiana Romulievna Moshonkina
申请人:Obschestvo S Ogranichennoi Otvetstvennostyu Kosima;
IPC主号:
专利说明:

[0001]
[0002] Device for the non-invasive electrical stimulation of the spinal cord
[0003]
[0004] Technical field
[0005]
[0006] The invention is related to medicine and medical technology, more specifically to the field of neurology and, in particular, it is considered a device for the non-invasive stimulation of the spinal cord, intended for the performance of diagnostic tests and different physiotherapies which can be carried out in therapeutic centers, preventive treatment and scientific research or in the patient's own home.
[0007]
[0008] State of the art
[0009]
[0010] In the Russian Federation, the frequency with which spinal injuries occur is 3.5 cases per year among 10,000 people, a percentage that tends to grow due to an increase in trauma in domestic, work or traffic accidents. as well as the increase of natural and technological disasters.
[0011]
[0012] The total number of people who become disabled as a result of a cerebrospinal or spinal cord injury exceeds 8,000 per year. However, this statistical data does not include a large number of patients with locomotor neurological disorders in the ambulatory treatment field (athletes, patients with infectious, neurotrophic or psychosomatic diseases, as well as patients with a locomotor deficit generated as a result of a "surgical aggression". "), Which also require specialized locomotive rehabilitation.
[0013]
[0014] The electrical stimulation of the spinal cord is a technique that, in the last years and in the field of physiatric rehabilitation (neurological rehabilitation), is showing great effectiveness. The electrical stimulation of the spinal cord consists of the direct application (electrode placement is carried out under operative conditions) of an electrical nature effect in the patient's spinal cord.
[0015]
[0016] In the dorso-lumbar intumescence of the spinal cord of the human being and of all mammals, there are neural networks that participate in the production and organization of locomotor movements. These neural networks (the generator of the locomotor movement) guarantee the rhythmic, stereotyped and coordinated activity of the muscles of each limb, the coordination between them and also the active coordination between the muscles of the trunk and the lower extremities for spatial displacement. It has been demonstrated (M. Dimitrijevic et al., Evidence for a spinal central pattern generator in humans, Ann. NY Acad. Sci., Nov. 16, 1998, 860: p.360-376) in patients immobilized by lesions at the level of Segments C5-T8 of the spinal cord that, by applying stimulating electrodes in the dura of the dorsal surface of the spinal cord, below the vertebrae T10-T12, and stimulating them with a current with a frequency of between 25 and 60 Hz and a amplitude of between 5-9 V, can be caused in them movements similar to locomotors in the act of walking. The electrical stimulation of the spinal cord aimed at causing movements similar to the locomotors in the lower extremities has given a good result in the autokinetic rehabilitation of the legs and in the functions of support and maintenance of body weight in patients with an absolute locomotor deficit. It has been demonstrated (Harkema S. et al Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study, The Lancet, 2011. T. 377. n ° 9781. Pags. 1938-1947), which, in patients with motor blockage at the level of the C7-T1 segments of the spinal cord, a chronic epidural and electrical stimulation, with a frequency of 40 Hz and a amplitude less than 5-10 V, across and at the L1-S1 segments of the spinal cord, combined simultaneously with a locomotor physiotherapy during a period of 7 months after the implantation of electrodes on the surfaces of the spinal cord , has had a positive effect on them. This electrical stimulation was applied to the patient three years after suffering the corresponding injury and, after it, the patient was able to stand between 4 and 25 minutes in that frame of constant electrical stimulation of his spinal cord. The patient was also able, lying on his back, to perform certain self-free movements with his legs, always within the framework of the application of a constant electrical stimulation of his spinal cord, and among them, in particular, to bend or extend the joints of the knee and ankle of his right or left leg.
[0017]
[0018] It is known the source of information where a certain method of treatment of patients with a chronic spinal cord injury is revealed (document RU 2204423 C2, publication 20.05.2003). In this method, the electrical stimulation of lumbosacral intumescence of the spinal cord is performed with the help of electrodes applied to the pachymeninge or dura mater of the spinal cord and that can cause movement of the legs of the patient, being in a rested position , lying on the back or side and with the legs suspended on swing frames. However, this method of treatment of patients with a chronic lesion in the spinal cord is invasive, since it involves the implantation of stimulating electrodes in the "hard mater" of the medulla, thus causing the consequent electrical stimulation of the same. below the level of the point of injury. The implementation of this method of treatment requires a surgical intervention for the implantation of the electrodes and a specific medical attention during the whole period of useful life of the stimulating electrodes, in order to avoid inflammatory reactions or an organic rejection of those.
[0019] Another source of information is also known that reveals another method of electrical stimulation of the spinal cord, consisting of a transcutaneous electrical effect on the spinal cord (document RU 2471518 C2, publication 10.01.2013). The main peculiarity of this type of stimulation is that it is painless for the human being. The low frequency bipolar pulse (5-30 Hz) is modulated with a high frequency component (2.5 kHz and above), which guarantees a painless stimulation. Thanks to the use of the electric impulse in this particular way, high amplitude currents can be supplied without pain, which penetrate efficiently from the skin surface to the structure of the spinal cord and generate spontaneous locomotor movements in the people subjected to it. test.
[0020]
[0021] The main advantage of the method of transcutaneous stimulation lies in the possibility of performing electrical stimulation with the help of skin electrodes, unlike direct electrical stimulation, which is performed by means of electrodes applied to the dura mater of the spinal cord and which requires an intervention Surgical for the placement of the electrodes in the medullary surface, with the consequent post-operative support and the risk of developing some operational or post-operational adverse complication.
[0022]
[0023] A non-invasive neuronal stimulator is also known which facilitates the rehabilitation of the locomotor, sensory, vegetative, sexual, vasomotor and cognitive functions (WO 2013071307 A1, publ 16.05.2013). This device is composed of a processor, a signal generator, electrodes and a memory element. This device generates bipolar impulses with a frequency between 0.5 and 100 Hz and an amplitude between 0.5 and 200 mA, pulses completed with a high frequency component of 5 or 10 kHz. The impulses can be applied in a cutaneous or paramedullary fashion in the neck and chest regions and in the lumbar and thoracic spine, and can be effective for the treatment and healing of numerous neurological diseases that cause movement deficits.
[0024]
[0025] Research carried out in the laboratory on animals with spinal cord injuries, which also induces other pathologies, should always precede the application of medullary electrical stimulation in the different treatment processes and the choice of stimulation parameters should be based on the results of those tests and in the evidence of rehabilitative efficacy that they have obtained. Laboratory research on animals has shown convincingly that epidural electrical stimulation of the lumbar spinal cord division is an unspecific activator of locomotor movements (Courtine G. et al., Transformation of nonfunctional spinal circuits into functional states after the loss of brain input, Nature Neuroscience, 2009. T. 12. No. 10. Pages 1333-1342, and others). The optimal locus of the spine for the induction of locomotion are the medullary segments L2-L4. The electric epidural stimulation of segments S1-S2 of the spinal cord do not cause locomotor movements in animals, but if they activate all the tensile muscles of their hind limbs, so that the stimulation of the spinal segments S1-S2 should be effective for the support of the weight of the body and its vertical position. A frequency of electrical stimulation of 5 Hz is effective for the provocation of movement in the entire spinal cord in the absence of supraspinal influences (Gerasimenko, YP and others) Particular features of the formation of locomotor patterns in a brainless cat with the application of an epidural stimulation. of his spinal cord, Russian Journal of Physiology "IM Sechenov", 2003. T-89, No. 9, pages 1046-1057). An epidural electro-stimulation frequency of the spinal cord (EEME) of 40 Hz is effective to cause locomotion and weight bearing of the body in cases of total blockage of the spinal cord in the infrateraxic division (Ichiyama RM et al., Hindlimb stepping movements in complete spinal rats induced by epidural spinal cord stimulation Neuroscience Letters 2005. V. 383, p.
[0026] 339-344).
[0027]
[0028] In this way, for the total restoration of reflex locomotor movements, and not only of the leg movements, but also to be able to walk autonomously with the control of body weight balance, it is necessary to influence simultaneously in several levels of spinal cord. However, we have seen that the sources of information mentioned above reveal methods and devices for stimulation of the spinal cord, describe an effect that is applied to a single core level and also in a very specific frequency band.
[0029]
[0030] At the technical level, a neurological stimulator is known (document US 20140180361 A1, published 26.06.2014) which allows up to four groups of electrodes to be stimulated simultaneously in the spinal cord. However, this device is applied in a medullary stimulation that is invasive, since the electrodes are implanted in the dura mater of the spinal cord. Therefore, it is impossible to use this device without performing a previous surgical operation.
[0031]
[0032] Also known is a method of electrical stimulation of the spinal cord, disclosed in document RU 2529471 C2, publ. 09.27.2014. This method includes the application of a sequential effect of rectangular bipolar electric stimuli in the form of meanders with a frequency between 5-40 Hz, a wavelength of 0.5 ms and a carrier frequency of 10 kHz in the spinal cord. of the patient, placed in the "decubito lateral" position, with the legs suspended in trampoline frames, while the effect is applied on the thoracic (T11-T12), cervical (C4-C5) and lumbar vertebrae (L1-L2). Depending on the segment of the spinal cord, the effect is applied by stimuli with an amplitude located within a band of 40-200 mA. The pulses in the supplied stimulus package have a fasic deviation of between 0.1 and 0.5 ms. The device with which this known method is applied is an electric stimulator that contains three galvanized channels of stimulation differentiated with a system of electrodes, connected respectively to the control block of the signal, to a microcontroller and to a signal shaper, as well as to the amplitude measuring block, to the indicator block and to the power block. This well-known method activates the movements of the patient's legs in the joints of the hip, knee and ankle.
[0033]
[0034] A non-invasive method of electrical stimulation of the spinal cord is also known, document RU 2545440, publ, on 27.03.2015, in which the effect is applied both in areas of the spinal cord located directly on the spinal column, between its apofisis. thorns, as well as on the roots of the spinal cord located symmetrically to the right and left of the spine, applying stimuli in the indicated areas and with the specified sequence. For this, a device containing matrices in the form of electrodes, an electric stimulator former, a control block, a microcontroller with computer software, a signal former, a current amplitude measurement block at the electrode input is used. and a block indicating the required parameters.
[0035]
[0036] A defect of the non-invasive stimulation of the spinal cord lies in its permissible indetermination of the location of the electrodes in relation to the segments and spinal roots that must be stimulated.
[0037]
[0038] When the modern technology of stimulation is used, the reference points for the choice of the place of the skin where the electrodes are to be placed are the ribs and the spinous processes of the spinal cord. And this is because both can be felt and felt under the skin. The layer of subcutaneous adipose tissue or significantly developed paravertebral muscles can make this exact location difficult. But not only they, also the peculiarities of the individual development, the injuries and the illnesses cause a deviation different from the norm in what refers to the anchorage and emplacement of the ribs and the vertebral column.
[0039]
[0040] A very reliable method to choose the best point of application of the electrodes on the skin in relation to the spinal cord is the registration of reflex muscle responses to isolated impulses supplied to the electrode: the responses of some muscles or others are determining the location of the stimulator electrode with a precision referred to the scale of a single medullary segment.
[0041]
[0042] One method is known (see Krenn M., Toth A., Danner SM, Hofstoetter US, Minassian K., & Mayr W. (2013) .Selectivity of transcutaneous stimulation of posterior lumbar roots at different spinal levels in humans. 58, 1), which consists of the transcutaneous stimulation of the spinal cord and the medullary dorsal roots in the region of Th11-Th12 vertebrae with the use of biphasic current impulses (2 x 1 ms) with an intensity of up to 125 mA. This method allows registering the reflex contractions of the muscles of the legs at each impulse, whose amplitude and shape will depend on the place of application.
[0043]
[0044] However, this method, although it provokes reflex responses of the muscles of the lower extremities, does not cause movements in the legs nor guarantees the control of said movements.
[0045]
[0046] The stimulating electrode is placed on the skin over the spinal cord and a pure, unmodulated, isolated impulse is applied to it. At a certain intensity of momentum, the muscles begin to contract. Muscle contraction sometimes comes to be seen directly.
[0047] For a qualitative record of the muscle contraction power, a superficial electromyography system is usually used. Each spinal segment enervates a limited group of skeletal muscles. The relationship "segment-muscles" is well known. If the electrode is located between the spinous processes of the vertebrae T11 and T12 and, with the stimulation of this zone, the vastus lateralis and rectus femoris muscles are actively contracted and, to a lesser extent, the hamstrings and the tibialis anterior, are You can conclude that the medullary segments L2-L3 are located under the electrode. However, it must be taken into account that the "vertebra-segment" relationship of a spinal cord may diverge from the norm due to some peculiarity of the ontogenesis or phylogenesis of the treated person. Finally, vertebrae can also be difficult to identify due to trauma and spinal injuries or other causes.
[0048]
[0049] We know that in order to record standard reflex responses of muscles we need to apply isolated pulses of rectangular type. But not one of the stimulators we know for transcutaneous electrical stimulation of the spinal cord generates that kind of impulse.
[0050]
[0051] Rectangular-type impulses are generated by industrial stimulators intended for neuronal research, but for the case that interests us, that is, for the execution of an effective rehabilitative procedure consisting of a non-invasive electrical stimulation of the spinal cord, we will need both a device that determines the exact positioning of the electrodes, as well as of another that carries out the rehabilitation procedure in sL In addition, the industrial stimulators generate impulses of an amplitude not higher than 100 mA. These amplitudes of current, in general, are not enough to induce a reflex response in the muscles of the legs in a transcutaneous stimulation of the spinal cord, all because of the degenerative processes that have suffered both the muscles and itself as consequence of some illness or injury.
[0052]
[0053] The experience of using these devices for the transcutaneous stimulation of the spinal cord has shown that the maximum amplitude of current allowed by their designs is 200 mA. A stimulation in this range of amplitudes may be sufficiently effective in experiments performed on healthy volunteers or during the rehabilitation of patients with a mild injury or illness, but this amplitude of current is clearly insufficient to cause a locomotor response in a procedure. of the neuromuscular stimulation of patients suffering a serious injury or an old disease of the spinal cord. In general, this is related to a high degenerative level of the muscles and the spinal cord itself as a consequence of a lesion or disease of that type. But in order to provoke a reflex locomotive response it is necessary to increase the energy of the impulses, either by increasing the amplitude of the high frequency bipolar impulses or by stimulating it with unipolar impulses, modulated or not.
[0054]
[0055] Therefore, of all that has been seen and at a technical level, there is no known device or apparatus for non-invasive spinal stimulation that combines the possibility of generating a double-stage effect in order to, on the one hand, specify the exact location of the electrodes. stimulators using rectangular-type asylated pulses with a maximum amplitude greater than 200 mA and, on the other hand, carry out an immediate and direct stimulation of the spinal cord by means of modulated pulses of different types and applied simultaneously in several segments and spinal roots. , also having the possibility to select the frequencies of both stimulation and modulation.
[0056]
[0057] Disclosure of the invention
[0058]
[0059] The objective of the present invention consists in the creation of an apparatus or device for the non-invasive electrical stimulation of the spinal cord that generates ntmic impulses. bipolar and unipolar of rectangular type, modulated with a high amplitude, and also unipolar pulses pure or unmodulated of rectangular type and with a maximum amplitude of current of 300 mA, that do not leave in the skin any potential and that allows to stimulate the spinal cord , as a minimum, up to three different medullary levels and simultaneously (cervical, thoracic and lumbar levels), as well as to stimulate the spinal cord roots at least in one of its levels. The apparatus thus created should also serve to study and explore the functions of any spinal cord, whether healthy and intact or diseased.
[0060]
[0061] The technical result of the present invention consists of increasing the effectiveness of the rehabilitation process in patients with pathologies of the spinal cord, that is, patients with severe locomotor deficits, including the total restoration of their free autokinetic movements, without the need for intervention. some surgical for the implantation of electrodes and also without risks derived from some foreign body implanted in the surface of the spinal cord.
[0062]
[0063] An additional technical result of this invention would be an expansion of the arsenal of technical resources destined for the transcutaneous stimulation of the spinal cord.
[0064]
[0065] This technical result is achieved thanks to a device for the non-invasive electrical stimulation of the spinal cord (electric stimulator), which contains five channels of stimulation with a system of electrodes, each of which includes, combined in series, a transformer voltage, a current generator and an output signal shaper, designed with the ability to generate bipolar modulated pulses, unipolar modulated pulses of rectangular shape and unipolar unmodulated pulses of rectangular shape, rhatmic or isolated, with a stimulation frequency between 1 and 99 Hz, a current amplitude between 1 and 300 mA and a modulation frequency between 4 and 10 kHz. The inputs of each one are linked to a microcontroller, which is connected in turn with an indicator block, control elements and a radio modulator. In addition, this microcontroller is designed with these capabilities: activate at least one stimulation channel, choose an independent start-up regime for each of the stimulation channels and control the parameters of the impulses in each of these channels, parameters that they are selected in relation to at least several factors: the type of impulse; the stimulation frequency, with a step of changing frequency of 1 Hz; the frequency of modulation with a step of changing frequency of 1 kHz; the current power with a change step of 1 A and the pulse wavelength with a change step of 0.1 ms.b.
[0066]
[0067] The microcontroller is also designed with the ability to start a stimulation channel in relation to the activity of another stimulation channel, with the task of executing a delay / pause and with the duration of the series of impulses.
[0068]
[0069] In addition, the microcontroller is designed with the ability to choose a start-up regime between a unitary regime with a passive phase of depolarization or a continuous regime with an active type of depolarization phase.
[0070]
[0071] In addition, the electric stimulator is synchronized with other external devices by means of a tactile input, for example, with devices for recording the locomotor response induced in the patient.
[0072]
[0073] In addition, the electric stimulator is connected in a supplementary way with a computer.
[0074]
[0075] In addition, the implementation of at least one channel of stimulation, the choice of a independent start-up regime for each of the stimulation channels, and the control of each stimulation channel with parameters of dynamic impulses could be carried out with the help of a computer and / or control elements and an indicator block .
[0076]
[0077] The electric stimulator is, therefore, an instrument for the study and exploration of the functions of an intact and diseased spinal cord, since the stimulator provides different types of impulses, it allows to create different stimulation scenarios and allows to synchronize each of the channels with external equipment, including registration devices. This technical achievement allows the stimulator to be used in fundamental and applied scientific studies and research.
[0078]
[0079] The possibility of influencing simultaneously and with the help of 5 channels of stimulation in 3 segments of the spinal cord, or in 3 spinal segments and in 2 spinal roots, or in 1 segment of the spinal cord and in 4 medullary or similar roots, allows restore in its entirety the voluntary movements of the person treated.
[0080]
[0081] The effectiveness of the stimulation of the spinal cord is increased as a result of a more precise location of the electrodes in the corresponding spinal segments, obtained thanks to an additional primary effect of activation of the muscles concerned, and the name of these activated muscles is also converted and the level of manifestation of their responses in the unequivocal indications of the correct location of the electrode in relation to a certain segment of the spinal cord.
[0082]
[0083] The possibility of varying the application of a specific stimulation regime, the choice of stimulating channels, the types of impulses of the stimulus, its parameters and, in particular, the regulation of the amplitude band of the output current and the frequencies both stimulation and modulation, all in relation to the level of affection or deficit of the medullary segment in question, allows us to carry out the stimulation of the spinal cord much more accurately and effectively, which facilitates a quick and better recovery of the functional capabilities of the patient.
[0084]
[0085] The fluctuation of the amplitude of the output current of the isolated pulses of the rectangular type is wider than in other known analogue devices, which allows to provoke a locomotor response to its rhythmic stimulation in patients with a significant and long-lasting injury or a spinal cord disease.
[0086]
[0087] All the rhythmic impulses seek to provoke a locomotor response or induce a tonic response of the muscles, necessary to maintain the vertical position of the patient. Following a decreasing order in relation to their effectiveness and the level of pain caused in the patients or people treated, these impulses are classified as follows: unipolar unmodulated, unipolar modulated and bipolar modulated.
[0088]
[0089] The property of the stimulator to generate a null potential in the skin just in the place of application of the electrodes allows to avoid possible burns of the skin caused by the great amplitude of the impulses.
[0090]
[0091] Brief description of the drawings
[0092]
[0093] The essence and nature of the technical solution that is stated here is also explained graphically.
[0094]
[0095] In Figure 1 a block-schematic of the stimulator is presented.
[0096] Figure 2 shows an example of placement of the electrodes in the human body.
[0097] A: seen from behind. B: seen ahead.
[0098] Figures 3A-3D show the different types of impulses that act on the spinal cord. In them: I - preset current, t - pulse length, T - pulse modulation period.
[0099] Figure 3A. Pure / unmodulated impulse with active phase of depolarization.
[0100] Figure 3B. Impulse not modulated with passive depolarization phase.
[0101] Figure 3C. Modulated unipolar impulse with active phase of depolarization.
[0102] 3D figure. Unipolar impulse modulated with passive depolarization phase.
[0103] Figure 3E. Modulated bipolar impulse.
[0104] Figure 4 shows an example of the possible temporal distribution of the pulse packets through the five channels of the stimulator.
[0105] An example of execution of the front panel of the stimulator is shown in Figure 5.
[0106] Figure 6 shows the original record of the recording of the locomotor responses caused by a transcutaneous stimulation of the spinal cord at the level of the coccyx (vertebra Co), by unipolar unipolar isolated impulses with an intensity of between 1 and 50 mA.
[0107] Volunteer citizen / DG tested.
[0108] Position 1: m. tibial right.
[0109] Position 2: m. right hamstring
[0110] Position 3: m. right biceps.
[0111] Position 4: m. right straight.
[0112] Position 5: m. vast right lateral
[0113] Position 6: m. vast left lateral
[0114] Position 7: m. left biceps.
[0115] Position 8: m. left straight.
[0116] Position 9: m. left tibial.
[0117] Position 10: m. left hamstring
[0118] Position 11: goniometer in the knee of the right leg.
[0119] Position 12: goniometer on the knee of the left leg.
[0120] Position 13: Signal / register of the first channel of the stimulator.
[0121]
[0122] Position 14: Signal / register of the third channel of the stimulator.
[0123]
[0124] Position 15: Signal / register of the fourth channel of the stimulator.
[0125]
[0126] Figure 7 shows the original record of the motor responses recorded in a transcutaneous stimulation of the spinal cord at the level of the coccyx (vertebra Co), with continuous unipolar modulated pulses with a frequency of 5 Hz, a frequency of modulation of 10 kHz, an intensity of 1-45 mA. Volunteer citizen / DG tested. The same designations as in figure 6.
[0127]
[0128] Figure 8 shows the original record of the motor responses recorded in a transcutaneous stimulation of the spinal cord at two medullary levels by means of four stimulation channels: the electrodes were located at the midline of the spine, between the Th11-Th12 vertebrae (third channel of the stimulator), above the vertebra Co (fourth channel of the stimulator) and above the roots of the spinal cord, to the right and left of the vertebra Th11 (first and second channel of the stimulator ).
[0129]
[0130] A modulated bipolar stimulation regime with a frequency of 30 Hz and a modulation frequency of 10 kHz was used in all channels. The first and second channel of the stimulator were activated in opposite phases: by the first channel, zero current, to change the shape factor of the impulses and act only on the right leg (1 sec of stimulation by the second channel, then 3 sec of delay). Current of 15 mA through channels 2-4. Volunteer citizen / DG tested. The same designations as in figure 6.
[0131]
[0132] Figures 9-11 show tables, which characterize the relationship between the preset current and the current measured by one of the channels of the stimulator.
[0133]
[0134] Table 1A. Relationship between the preset current and the current measured in a test performed on the first channel of the electric stimulator at the frequencies of 10, 30 and 99 Hz. Unmodulated unipolar impulse.
[0135]
[0136] Table 1B. Relationship between the preset current and the current measured in a test performed on the first channel of the electric stimulator at frequencies of 10, 30 and 99 Hz. Modulated unipolar impulse. Modulation frequency of 10 kHz.
[0137]
[0138] Table 1C. Relationship between the established current and the current measured in a test performed on the first channel of the electric stimulator at frequencies of 10, 30 and 99 Hz. Modulated bipolar impulse. Modulation frequency of 10 kHz.
[0139]
[0140] Designations
[0141]
[0142] 1-5. Identical channels of the stimulator.
[0143]
[0144] 6. Current generator.
[0145]
[0146] 7. Voltage transformer.
[0147]
[0148] 8. Conformator of the output signal.
[0149] 9. Microcontroller.
[0150] 10. Indicator block.
[0151] 11. Keyboard.
[0152] 12. Radio module of the electric stimulator.
[0153] 13. Power block.
[0154] 14. Accumulator battery.
[0155] 15. Electric stimulator.
[0156] 16. Computer.
[0157] 17. USB port of the computer.
[0158] 18. Computer radio module.
[0159] 19. Patient.
[0160] 20-24. Active electrodes, cathodes.
[0161] 25, 26. Passive electrodes, anodes.
[0162] 27. Power button.
[0163] 28. Emergency shutdown button.
[0164] 29. Ignition panels and activity control of the five channels.
[0165] 30. Channel power button.
[0166] 31. Channel availability indicator to operate.
[0167] 32. Two-color indicator of channel activity (current greater than 0 mA)
[0168] 33. Selective channel button for the operative working configuration.
[0169] 34. Selective button of the working regime of the chosen channel.
[0170] 35. Selective frequency button of the impulses for the chosen channel.
[0171] 36. Selective wavelength button of the impulse for the chosen channel.
[0172] 37. Selective button of the amplitude of current through the chosen channel.
[0173] 38. Indication of the resistance under the electrode for the chosen channel.
[0174] 39. Indicator / Alphanumeric chart of liquid crystal, panel / luminescent diode screen where the established and measured values are reflected.
[0175] 40. Connection plug to a 220 V network.
[0176]
[0177] 41. Charge activation button for accumulator batteries.
[0178]
[0179] Realization of the invention
[0180]
[0181] Electric stimulator (figure 1, item 15) that is composed of five identical channels of stimulation (1-5). Each of these channels contains, connected in series, a current generator (6), a voltage transformer (7) and an output signal shaper (8). Each of the five stimulation channels is connected to a microcontroller (9), which in turn is connected to an indicator block, designed as an alphanumeric display device (10), and a keyboard (11). The microcontroller is also connected to a radio module (12). The electric stimulator also contains a feed block (13) and a storage battery (14).
[0182]
[0183] The microcontroller is designed with the ability to start at least one stimulation channel, to choose the start-up regimen, independent for each of the stimulation channels, in addition to controlling and managing the impulse parameters of each one. of the stimulation channels, parameters related to the type of impulse, the frequency of the stimulation -with a step of changing the frequency in 1 Hz-, the frequency of modulation -with a step of changing the frequency in 1 kHz-, the power of current - with a step of change in 1 A - and the wavelength of the impulse - with a step of change of 0.1 ms.
[0184]
[0185] In one of its variants of embodiment, the electric stimulator can be connected to a computer (16), either through a USB port of the computer (17), or by a radio channel through the computer's radio module (18). ).
[0186]
[0187] Each of the five channels of the electric stimulator is connected to the electrodes placed in the patient's body (19) by means of cables (figure 2). The electrodes will have a concrete geometric design so that they can be installed between the spinous processes or exactly on the roots of the spinal cord, for example, circular with an approximate diameter of 2 cm.
[0188]
[0189] The active electrodes (cathodes) are installed on the skin: paraspinally in the cervical, thoracic and lumbar regions or dens of the vertebral column or in the coccyx and / or paravertebral area, in the plane of the roots of the spinal cord (figure 2, item 20 24). The passive electrodes (anodes) are installed, for example, in the belly area, on the iliac bones (25, 26). The passive electrodes act as general "ground points" for all active electrodes.
[0190]
[0191] Each of the channels of the electric stimulator generates current pulses in a band of 1 to 300 mA, with a step of 1 mA. Currents less than 40 mA can be used to determine the contraction thresholds of those muscles that respond to stimulation of the spinal cord. The use of currents greater than 250 mA allows a reaction to those spinal cord structures and structures, whose excitability is reduced as a result of the disease or injuries and does not react to pulses below 250 mA.
[0192]
[0193] The electric stimulator is synchronized by a tactile input with the external equipment, intended, for example, to record the locomotive response caused.
[0194]
[0195] The impulse can be one of the following three types: unipolar rectangular unmodulated (figures 3A, 3B), rectangular unipolar modulated (figures 3C, 3D) or bipolar rectangular modulated (figure 3E). The ability of the electric stimulator to generate these three types of impulses allows its application in the search of different objectives: for the study and the exploration of the spinal cord pathways of patients or people in norm (on healthy volunteers for the study of the functions of a normal spinal cord) or for the cure / rehabilitation of patients with spinal cord injuries of varied severity.
[0196]
[0197] The unmodulated unipolar impulses are used to provoke the response of the structures below the stimulation point (exploration). Modulated bipolar impulses are used in experiments designed to induce quasi-locomotor movements in healthy volunteers, stimulating their spinal cord, since people with normal sensitivity can cope without pain. A continuous sequence of modulated bipolar impulses, unipolar modulated pulses or unipolar unipolar impulses is applied to stimulate the spinal cord and cause movements similar to those performed when walking in patients with spinal diseases / lesions (the choice of type of impulse depends on the excitability of the patient's spine, the patient's pain sensitivity or equivalent factors).
[0198]
[0199] The frequency of the modulation should be between 4 and 10 kHz, with a step of 1 kHz. In this way, the electric stimulator could be used to carry out studies on the effect of the modular frequency of the unipolar unipolar or bipolar rectangular impulses on the characteristics of the locomotor response or other similar elements.
[0200] The frequency of repetition of the impulses can be established between 1 and 99 Hz, with a step module of 1 Hz. In this way, the electric stimulator could be used in research aimed at studying the frequency effect of modulated rectangular monopolar impulses or unmodulated, and also modulated rectangular bipolar impulses, on the characteristics of locomotor responses or other similar elements.
[0201]
[0202] The average current supplied by the stimulator per channel (continuous current component) equals zero. That is why an unmodulated impulse and a unipolar modulated impulse have a depolarizing phase of reversed polarity current (depolarizing "tail") (Figures 3A - 3D). Two types of depolarizing phase are possible: passive and active. The passive phase is characterized by a weak depolarizing current and a long duration of the depolarizing phase: the constant of the current attenuation time is equal to 2 s (Figures 3B, 3D). The active depolarizing phase is characterized by a relatively strong depolarizing current - with possible values equivalent to 1/5 of the established current for the unmodulated pulse and 1/10 of the current set for a modulated unipolar pulse (Figures 3A, 3C) - and a relatively short duration of the depolarizing phase, equivalent to 5 times the duration of the impulse.
[0203]
[0204] Only one channel is active at any time. This means that when a pulse passes through a channel, in that precise fraction of a millisecond there is no impulse in the other channels. This has been done to avoid a sum of impulses and, consequently, to protect the patient from unpredictable current currents.
[0205]
[0206] However, if simultaneous stimulation by the 5 channels is possible.
[0207]
[0208] The activity time of the channel comes both from the duration of the impulse and from the duration of the active depolarizing phase of the channel, if it has one. In this way, the total operating frequency of all channels is limited. The total duration of the active state of all channels in a unit of time does not exceed said unit of time. For example, if unipolar pulses modulated with a duration of one ms with an active depolarizing phase and the same repetition frequency of the impulses, then this frequency does not exceed 1000 ms / (6 ms x 5 channels) «33 Hz.
[0209]
[0210] Both the control and management of each stimulation channel (1-5) of the electric stimulator (15), as well as the start-up of at least one stimulation channel (1-5) and the selection of the independent start-up regimen in each channel of stimulation (1-5) can be autonomous: either only the control elements and the indicator block located on the front panel of the electric stimulator (15), or the control elements located on the front panel of the stimulator electrical (15) and computer (16). In the second case, the electric stimulator (15) must be connected to the computer (16), either with a USB cable or via a radio channel. The elements of control and management are the buttons that are located on the panel of the electric stimulator and with them you can choose the channel to be controlled, the stimulation regime, the amplitude of the impulses, etc.
[0211]
[0212] A schematic example of the temporal distribution of pulse packets across all channels is shown in Figure 4.
[0213]
[0214] Thus, in some variants of manufacture and design, the electric stimulator has the ability to select the configuration of the parameters, either autonomously, remotely or by remote control using the computer.
[0215]
[0216] The possibility of directing the electric stimulator through the computer will allow us: first, to design complex scenarios of stimulation, something that can be applied both in research tasks and in the treatment processes; secondly, save and maintain a characteristic picture of stimulation (amplitude, frequency, order of operation of the channels, etc.) in the memory of the computer for its analysis and subsequent application in a certain process of treatment or other similar procedures, so how to copy it to another computer or device similar to the established one; thirdly, to synchronize the work of the stimulator with other devices for stimulation, registration or with other functions, all of them directed and managed from the computer; and fourth, the possibility of controlling part of the parameters simultaneously, both in the computer and in the stimulation panel or, what is the same, a comfortable operation of the stimulator: the stimulator will always be quite close of the patient / person examined (at a distance that allows the length of the stimulator electrode cables) and, being close to the patient, he / she will be able to change the parameters of the stimulating current depending on the reaction of the same, even in those cases in which The main direction of the electric stimulator is carried out from the computer, which can be found at a significant distance from the electric stimulator, only limited by the length of the USB cable or the radius of action of the radio channel.
[0217]
[0218] The device whose patent is sought here has two regimes of emission or activation of the stimulations: single or one-time activation and continuous activation. In addition, the regimes of the different channels are selected independently, that is, part of those channels can work in a single activation regime and "by hand", while others do it in a continuous regime.
[0219]
[0220] In the single activation regimes a passive type of depolarization phase is established. In these regimes the charge that is issued during the whole duration of the series does not exceed 1 mC: that is, the number of pulses in the series does not exceed a certain magnitude, which depends on the determined current and the type and duration of the impulse. . For example, in a stimulation with modulated unipolar pulses of 100 mA and with a duration of 1 ms, the number of pulses in a series does not exceed 1000 | iC / 100 mA x 0.5 x 1 mC) = 20 pulses.
[0221] In the single regimes, the time elapsed between consecutive emissions is not less than 5 s.
[0222]
[0223] If these conditions are not met in the unique activation regimes, a current limitation of the stimulation current may occur.
[0224]
[0225] The unique stimulation regimen can be used, for example, to record the reflex activity of the muscles in the stimulation of the spinal cord.
[0226]
[0227] Any of the channels can work in emission or external activation regime. In this case, the channel emits current pulses or silences according to the status of one of the two input logic signals:
[0228]
[0229] the channel works with a high level of the first synchronous signal and silences with a low level of this same signal,
[0230]
[0231] the channel works with a low level of the first synchronous signal and is silent at a high level of this same signal,
[0232]
[0233] the channel works with a high level of the second synchronous signal and shuts down at a low level of this same signal,
[0234]
[0235] the channel works with a low level of the second synchronous signal and shuts down at a high level of this same signal.
[0236]
[0237] The choice of one variant or another is made independently for each channel. The diversity of possibilities of emission or activation of the stimulator, as a result of the different types of synchronous signal, makes compatible any of the five channels with practically any external device that has a tactile input.
[0238]
[0239] The existence of 5 channels and the particularities of emission or activation of the channels (from the button on the stimulator panel, from the computer, from any stimulator channel or from an external synchronous pulse device) allow: stimulating simultaneously or successively between 1 and 5 levels of the spinal cord, programming complex scenarios of spinal cord stimulation and synchronizing the stimulation with the functioning of external devices (stimulators or record).
[0240]
[0241] One of the variants or versions of the stimulator that responds to the technical solution of the device proposed here is shown in figure 5. The external panel of the stimulator contains a connection or ignition button (27), an off or close button Immediate stimulation for all channels (28) and identical connection and activity control panels for each of the five channels (29). Each channel has an emission or activation button (30) and a luminescent diode that indicates the operative situation of the channel and that lights up when the channel is connected (31) and of a two-color luminescent diode current indicator, which turns on when the channel is emitting current pulses, illuminating in green when the current remains at the set margins or in red when the current is outside those margins (for example, by a rupture of the electrode circuit) (32) . The autonomous operation of the stimulator is carried out from the direction devices and the indicator block installed in the device. To configure the operation of each channel, we will select the channel number with a button (33), the number of that channel will be immediately reflected in the panel (39). The operating regime of the channel is selected by a button (34) and the alphanumeric code of the same is immediately reflected in the panel (39). When the autonomous management and control system is used, it is not possible to have access to all the activation regimes that the device can perform. You can choose any of the three types of impulses and only one of the two activation regimes: continuous or unique, by pressing the button 4. The code that identifies a certain operating regime is composed of two symbols: the first codes the type of activation and the second type of impulse. The continuous activation is coded with the "C" symbol, the only one with "1". The unmodulated pulse type is coded with the "N" symbol, the unipolar modulated with the "M" symbol and the bipolar modulated with the "B" symbol. The pulse frequency, the duration of the single pulse and the selected channel current amplitude are programmed with the keys (35, 36 and 37, respectively) and the selected options are immediately reflected in the panel (39). The magnitude of resistance that exists under the electrode is also reflected in the panel. To charge the accumulator batteries installed in the stimulator, there is a connection socket with the 220 V network (40) and a battery charging button (41).
[0242]
[0243] The computer is designed to have the capacity to supply independently and to each channel the following: a certain intensity of current, a frequency of stimulation, a type of impulse, a duration of the impulse and an activation regime of each channel. The computer is designed to activate each channel separately. Unlike the direction from the panel of the electric stimulator with the help of the control devices and the indicator block, using the computer can also command the activation of the channel in direct relation with the activity of any other channel of the stimulator (the regimens " unique from the channel "and" continued from the channel "), choosing the delay time and the duration of the series. Another difference in relation to the direction of the stimulator through the computer is that each channel with an established current is indexed a measured current.
[0244]
[0245] The relationship between the established and measured currents in one of the channels of the stimulator is shown in Figures 9-11, in tables 1A-1C. The difference between one and another, in general, is less than or equal to 2 mA.
[0246]
[0247] The studies and research were carried out in the experimental base of the State Academy of Sport and Physical Culture of Belarus. For these tests, 7 physically healthy volunteers were offered.
[0248]
[0249] The active electrodes were located in the central line of the spinal column between the spinous processes of vertebrae C4-C5 and Th11-Th12 and, in the region of the coccyx (vertebra C0), on the right and left roots of the spinal cord in the Th 11 vertebra region. As electrodes, round electrodes with a diameter of 2.5 cm and an adhesive layer were used (Lead-Lok, Sandpoint, USA). Each electrode was connected to a stimulator channel. As passive electrodes, a pair of rectangular electrodes with dimensions of 5 x 10 cm2 was used with an adhesive layer (Ambu, Ballerup, Federal Germany). The passive electrodes were placed on the skin in the belly region, on the left and right iliac bones. The passive electrodes were connected to each other and acted as "grounding" of the active electrodes.
[0250]
[0251] The voluntary locomotor movements and reflexes were carried out in the facility described by VS Gurfinkel and other co-authors. [Gurfinkel VS, Levik YC, Kazennikov OV and Selionov VA: "Is there a generator of locomotor movements in the human being " Human physiology, T. 24, n ° 3, pgs. 42-50, 1998]. With the feet suspended horizontally, the function of sustaining the weight of the body is eliminated, at the same time that it is possible to generate independent movements of both legs, since the person under test is lying on his side and his legs are straight. and left are in independent hangers. In our investigations the Voluntaries under test were lying on their left side, the right lower extremity (the top one) was supported directly by the tibia area and the left (the bottom one) was placed in a rotating cylinder, attached to a table arranged horizontally (1155 x 200 mm, 3 kg), supported by ropes tied to a hook on the ceiling (Fig. 1). The instructions given to the volunteer under study were not to hinder or help the movements caused by the stimulator.
[0252]
[0253] The electromyograms (EMG) of 10 muscles of both legs (rectus femoris m, femoral m.biceps, m.stous lateralis, anterior tibialis and gastrocnemius M.) were abducted by superficial bipolar electrodes. The signals of the electromyograms were recorded with the help of a 16-channel telemetric electroneuromyograph (ME 6000 MegaWin, Finland). The movements of the legs in the joints of the knees were recorded by goniometers, also integrated into the list of the ME 6000 MegaWin equipment. In the three channels of this electroneuromyograph signals of three stimulator channels were poured, the first, third and fourth channels of the stimulator. This selection was determined by the fact that the first and second channels of the stimulator were used for a paired stimulation of the spinal cord roots, where the rhythm of activity of the first channel determined the activity of the second channel. The information of this interrelation was kept in the protocol of the test and then it was reproduced at the end of it. The third channel of the stimulator was used in the stimulation of the spinal cord at the level of the Th11-Th12 vertebrae. The fourth channel of the stimulator was used in the stimulation of the spinal cord at the level of the coccyx, the vertebra Co. The fifth channel of the stimulator was used in the stimulation of level C5, but it was not possible to record the synchronous signal of this channel in the electroneuromyograph, since the last channel, channel 16 of this last device was used for the signal and service mark of the video system (Qualisys, Sweden) that recorded and recorded the kinematic characteristics of the movements of the legs (and whose data they are not represented here).
[0254]
[0255] Figure 6 shows the locomotor responses to stimulation with unipolar single unipolar impulses of a duration of 1 ms. The current of stimulation was supplied with different intensities, measured in mA, each of which was repeated three times: 1, 10 (the volunteer treated felt the effect), 20, 30, 40 (the volunteer treated felt the effect and reacted in a "painless" way) and 50 mA (the volunteer treated felt the effect, he reacted in a "painless" way and the observers present could notice the locomotor response of the muscles of his legs). We have reflected the marks and registers of the impulses corresponding to the recording of channel 15 (figure 6, pos.15). The durations of the signals were made longer than the pulse durations so that the analog-numerical transformer would not escape without recording the impulses with a used discrimination frequency of 2 kHz. The stimulation artifacts are visible in the EMG of the muscles of the thighs, starting from the first intensity of 1 mA (figure 6, pos 3-8). The reflex locomotor response is observed in the muscles of the thighs from the intensity of 10 mA, while the muscles of the tibia (figure 6, pos. 1,2, 9 and 10) respond to a current intensity of 30. mA and above.
[0256]
[0257] In this way, the stimulator can be used for the transcutaneous stimulation of the spinal cord in order to record and record the reflex responses of the stimulated muscles.
[0258]
[0259] Figure 7 shows the locomotor responses to stimulation with unipolar pulses modulated and continuous with a duration of 1 ms, a stimulation frequency of 5 Hz and a modulation frequency of 10 kHz. The intensity of the current was gradually increased from 1 to 45 mA. The duration of the signal by the record channel 15 (figure 7, item 15) corresponds to the duration of the stimulation. All designations and nomenclatures are identical to those in Figure 6. In In the electromyographic signal registers, an increase in the muscular response is observed as the stimulation current increases (figure 7, pos 1-10). The locomotor response, the movements of both legs, start at approximately an intensity of the stimulation current of between 30-40 mA. This was also observed during the execution of the stimulation session, as stated in the protocol. In the original record you can see the activity through the goniometer channels (figure 7, pos 11 and 12): you can see the increase in the amplitude of flexion in the knee joints of both legs as the current of stimulation increases . The push-ups are unidirectional, with a small delay, presenting as synchronic movements of the two legs back-forward. This is also what appears in the video recording during the registration of the cinematic movements (which are not reflected in this application). At the end of the stimulation, in the 103 seconds of the recording (figure 7, item 15), both the prolonged attenuation of the movements of both legs and the electromyographic activity in packs in the muscles of the thighs are visible (figure 7, Pos 4 and 6).
[0260]
[0261] In this way, the stimulator can be used for transcutaneous stimulation of the spinal cord in order to cause reflex movements. In the example provided, both legs initiated unidirectional synchronic movements.
[0262]
[0263] Figure 8 shows the original recording of locomotor responses, caused by a transcutaneous stimulation of the spinal cord at two levels of the same and through four stimulation channels: the electrodes were located in the midline of the spine dorsal, between the vertebrae Th11-Th12 (third channel of the stimulator, position 4 in figure 8), on the vertebra Co, the coccyx (fourth channel of the stimulator, position 15 in figure 8), on the roots of the spinal cord, left and right vertebra Th11 (first and second stimulator channel). The first and second channels of the stimulator were activated in push-pull, by the first channel a null current, to modify the shape factor of the impulses and act only on the right leg (1 sec of stimulation by the second channel, then 3 sec Delay: the first channel corresponds to position 13 in Figure 8). A modulated bipolar stimulation regimen with a frequency of 30 Hz and a modulation frequency of 10 kHz was applied to all channels. Current intensity of 15 mA through channels 2-4. A low current intensity was chosen, twice less than that which caused reflex movements of the legs in the same volunteer under test. During the first three seconds of stimulation, when the stimulation of the spinal cord flows to the level of Th11-Th 12 and coccyx (Co), and with an insufficient intensity of current to cause movements, a tonic tension of the muscles is appreciated of the thighs / hips (figure 8, item 4-8), but there is no record of leg movements. In the fourth second, stimulation begins in the second channel, which stimulates precisely the right root of the spinal cord at the level of the vertebra Th11. This causes leg movements similar to those of walking, with the right leg reacting first (figure 8, item 11). At 20 sec from the beginning of the stimulation, and in response to the stimulation of the right root of the spinal cord, right leg movements similar to locomotors begin to develop (Figure 8, Item 12). At 30 seconds from the start of the stimulation, the right leg movements are seen with greater amplitude, with episodes in which the left leg performs movements very similar to those of walking in opposition of phase with the right leg. The movements continue for 5 more seconds after finishing the stimulation.
[0264]
[0265] In this way, the stimulator can be used to cause reflex movements of the legs and to manage and direct these movements. In the example provided, the process was started with similar movements when walking on the right leg, but then these quasi-locomotor movements continued in both legs.
[0266] The description set forth above explains, but in no way limits, the capability of the present apparatus. Although this is described here on the basis of a single variant example of realization of the same, it must be understood that the explanations and clarifications given in this document are only illustrative and not limiting of possible processes. Modifications of the device can be introduced, but always within the competences and scope of the claiming game of the invention proposed here. Although the invention described in this document refers to specific variants of execution and design, that is not limited only to the technical features disclosed in this document, but rather the invention functionally extends to all structures, methods and equivalent applications, provided they are based on the claiming game of the invention proposed here.
权利要求:
Claims (7)
[1]
1. Device for the non-invasive electrical stimulation of the spinal cord, characterized in that it comprises five channels of stimulation with an electrode system, including each of the channels a voltage transformer, a current generator and an output signal shaper connected serially; because the channels have the capacity to generate unipolar bipolar and rhytmic dynamic modulated pulses of rectangular type and also unipolar pulses of rectangular type, either well isolated or with a stimulation frequency within a band between 1 and 99 Hz, with a amplitude of the current from 1 to 300 mA and with a modulation frequency of 4 to 10 kHz; because the inputs of the channels are connected to a microcontroller, which in turn is connected to an indicator block, some direction and control elements, and a radio module; and because the microcontroller is designed and executed with the ability to:
- launch at least one stimulation channel,
- select an independent emission or activation regime for each stimulation channel,
- control and direct in each of the stimulation channels the parameters of the impulses, the parameters chosen at least by:
the types of impulse,
the frequency of stimulation, with a step of changing frequency of 1 Hz,
the frequency of modulation, with a step of changing frequency of 1 kHz,
the intensity of the current, with a current change step of 1 mA,
the duration of the impulse, with a change of duration of 0.1 ms.
[2]
Device according to claim 1, further characterized in that the microcontroller is designed and executed with the ability to select an emission or activation regime between a single regime (at one time) with a passive phase of depolarization and a continuous regime with an active type of depolarization phase.
[3]
Device according to claim 1, further characterized in that it is synchronized with external synchronous input devices and with devices for recording the locomotor response caused by the stimulation.
[4]
4. Device according to claim 1, further characterized in that it is additionally connected to a computer.
[5]
Device according to claim 1, further characterized in that all of these functions, i.e. the activation of at least one stimulation channel, the selection of an independent start-up regime for each of the stimulation channels, and The direction and control of each of the stimulation channels through the parameters of the impulses, can be done with the help of a computer.
[6]
Device according to claim 1, further characterized in that all of these functions, i.e. the activation of at least one stimulation channel, the selection of an independent start-up regime for each of the stimulation channels, and the direction and control of each of the stimulation channels through the parameters of the impulses can be made with the help of a computer, control and direction elements, and a display block.
[7]
Device according to claim 1, further characterized in that all of these functions, i.e. the activation of at least one stimulation channel, the selection of an independent start-up regime for each of the stimulation channels, and the direction and control of each of the stimulation channels by means of the pulse parameters can be carried out with the help of control and direction elements and an indicator block.
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公开号 | 公开日
ES2711200R1|2019-10-29|
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