CN115337549A

CN115337549A - Electrical stimulation regulation and control device and method for muscle tension abnormality of spastic cerebral palsy patient

Info

Publication number: CN115337549A
Application number: CN202210099912.3A
Authority: CN
Inventors: 隋晓红; 王心桐; 肖波
Original assignee: Shanghai Jiaotong University
Current assignee: Shanghai Jiaotong University
Priority date: 2022-01-27
Filing date: 2022-01-27
Publication date: 2022-11-15
Also published as: WO2023142659A1

Abstract

The invention provides an electrical stimulation regulation and control device for abnormal muscle tension of a spastic cerebral palsy patient, which comprises: the nerve stimulation device comprises an electrical stimulation unit and a control unit, wherein the electrical stimulation unit comprises at least one stimulation electrode, the stimulation electrode is arranged in or out of the fasciculus of at least one target nerve root and is used for applying an electrical stimulation signal to the at least one target nerve root; the control unit is used for controlling the stimulation parameters of the electrical stimulation signals. The electrical stimulation regulation and control device has the advantages of small wound and adjustable parameters, does not need to cut off nerve roots, avoids irreversible damage caused by an SDR (standard definition connector) operation mode, and reduces the injury of a patient.

Description

Electrical stimulation regulation and control device and method for muscle tension abnormality of spastic cerebral palsy patient

Technical Field

The invention mainly relates to the field of medical instruments, in particular to an electrical stimulation regulation and control device and method for abnormal muscle tension of a spastic cerebral palsy patient.

Background

Cerebral Palsy (CP) is a non-progressive syndrome of brain damage due to a variety of causes in early stages of brain development in infants from pre-natal to one month after birth. About 3 ten thousand new cases are developed in China each year, and 70-80% of cases are spastic cerebral palsy. Spastic cerebral palsy is mainly manifested in spasticity of limbs and trunk of patients, and is due to the following reasons: the central pyramidal tract of the brain is damaged due to various reasons, so that the inhibition effect of descending upper motor neurons on the spinal nerve network is weakened, and the continuous enhancement of the efferent myotonia signals is triggered, and the efferent myotonia signals are simultaneously influenced by real-time afferent dynamic signals from the muscle spindle through the posterior root nerve of the spinal nerve. For the treatment of spastic cerebral palsy, the spasm degree of affected limbs of a patient is effectively and durably reduced in an early stage, and the treatment method is of great importance for improving the rehabilitation treatment effect of the patient in the future, improving the motor function of the patient, and relieving the pressure of a medical system and the whole social burden.

Currently, no mature technology is available clinically for improving the inhibitory signal of the descending of the pyramidal tract, so doctors often use Selective posterior nerve root dissection (SDR) to moderately reduce the afferent signal of the posterior spinal nerve root, so as to inhibit the strength of the efferent signal of muscular tension, and to some extent, to relieve the stiffness of muscles, improve motor function, and relieve the pain of muscles and joints. The SDR technique completely depends on Intra-operative Neuroelectrophysiological Monitoring (IONM), and judges whether the nerve root is a responsible nerve bundle causing spasm of the muscle group according to the electromyographic expression of the monitored muscle group induced by the electrical stimulation of the dorsal root fasciculus of the spinal nerve, and then carries out the disconnection of the dorsal root.

Different treatment centers and surgeons use different surgical treatment protocols when implementing SDR. The conventional treatment scheme is to cut off all dorsal root ganglion parts reaching above 3 and 4 levels capable of exciting a wide range of abnormal neuroelectrical activities by means of Grading results of an Electromyography (EMG) Response Grading System. This method is very effective in moderate and severe cases. Some mildly spastic CP patients have difficulty in achieving EMG response ratings above grade 3 or 4. There is also a general SL-SDR (Selective nasal respiratory muscular a single-level approach) operation treatment scheme proposed by a diagnosis and treatment team, based on the result of muscle tension level division on different muscle groups of a patient by using improved Ashworth grading before an operation, the muscle group with the grade more than or equal to 2 is set to be classified as a target muscle group. The nerve root is subsequently tested intraoperatively using a neuroelectrophysiological monitoring system and a single-stage electrode, and the nerve root is severed only if the EMG signal in a muscle group simultaneously matched to 200 μ V is reached and the muscle group belongs to a target muscle group. Compared with the traditional method, the method has targeting property and higher sensitivity, and can be suitable for SDR operations of spastic CP patients in various degrees.

Although the current surgical treatment scheme using SDR achieves better effect of weakening the muscle tension of patients and can improve the spasticity of patients to a certain extent, the following disadvantages still exist in this surgical treatment method: firstly, the SDR operation type has irreversible destructiveness, and the dorsal root ganglia lose partial functions after being separated in the operation and cannot be repaired in the future; secondly, after the ganglia are dissociated by the SDR operation, the muscle spasm improvement effect of specific cases can only be evaluated after the operation, but the later regulation and control are difficult to carry out, if the weakening degree of the muscle tension is not ideal, the operation can only be carried out again, so that larger trauma is generated, or the complicated and slow exercise rehabilitation treatment is accepted in the later period.

In order to reduce the irreversible injury suffered by the patient, a personalized treatment means which has small formed wound and can be effectively regulated and controlled according to the treatment effect after the operation is needed.

Disclosure of Invention

The invention aims to provide an electrical stimulation regulation and control device and method which are small in trauma and can effectively improve abnormal muscle tension of spastic cerebral palsy patients.

In order to solve the above technical problem, the present invention provides an electrical stimulation control device for abnormal muscle tension of a spastic cerebral palsy patient, comprising: the device comprises an electrical stimulation unit and a control unit, wherein the electrical stimulation unit comprises at least one stimulation electrode, the stimulation electrode is arranged in or out of a bundle of at least one target nerve root, and the stimulation electrode is used for applying an electrical stimulation signal to the at least one target nerve root; the control unit is used for controlling the stimulation parameters of the electrical stimulation signals.

In an embodiment of the present invention, the method further includes: a recording unit, wherein the stimulation electrode includes a first stimulation electrode, the target nerve root includes a spinal anterior motor root, the electrical stimulation signal includes a first electrical stimulation signal, the first stimulation electrode is disposed within or outside a bundle of at least one spinal anterior motor root, and the first stimulation electrode is used for applying the first electrical stimulation signal to the at least one spinal anterior motor root; the recording unit comprises at least one recording electrode, the recording electrode is arranged in or out of the fasciculus of the at least one spinal cord anterior root motor nerve root and is used for recording the electric signals generated by the at least one spinal cord anterior root motor nerve root; the control unit is used for controlling the recording time of the recording electrode and controlling the stimulation parameter of the first electric stimulation signal according to the electric signal.

In an embodiment of the present invention, the control unit is further configured to extract an active motor nerve signal emitted by the brain from the electrical signal, and control a stimulation parameter of the first electrical stimulation signal so that the active motor nerve signal is amplified.

In an embodiment of the present invention, when the change rate of the electrical signal exceeds a preset threshold, the control unit determines that the electrical signal is the active motor nerve signal.

In an embodiment of the present invention, when the control unit determines that the electrical signal is the active motor nerve signal, the control unit controls the first stimulation electrode to deliver the first electrical stimulation signal.

In an embodiment of the present invention, the stimulation electrode includes a second stimulation electrode, the target nerve root includes a posterior spinal root sensory nerve root, the electrical stimulation signal includes a second electrical stimulation signal, the second stimulation electrode is disposed within or outside a bundle of at least one of the posterior spinal root sensory nerve roots, the second stimulation electrode is configured to apply the second electrical stimulation signal to the at least one posterior spinal root sensory nerve root to inhibit afferent of the sensory signal; the control unit is further configured to control a stimulation parameter of the second electrical stimulation signal.

In an embodiment of the present invention, the stimulation electrode further includes a second stimulation electrode, the target nerve root includes a posterior spinal root sensory nerve root, the electrical stimulation signal includes a second electrical stimulation signal, the second stimulation electrode is disposed within or outside a bundle of at least one of the posterior spinal root sensory nerve roots, the second stimulation electrode is configured to apply the second electrical stimulation signal to the at least one of the posterior spinal root sensory nerve roots to suppress afferent of the sensory signal; the control unit is further configured to control a stimulation parameter of the second electrical stimulation signal.

In an embodiment of the invention, the limb monitoring device further comprises at least one electromyographic recording electrode, wherein the electromyographic recording electrode is arranged on the surface of a limb of a patient or in subcutaneous muscle tissue of the limb of the patient and is used for recording an electromyographic signal; the control unit is also used for controlling the recording time of the electromyographic recording electrode and controlling the stimulation parameter of the second electrical stimulation signal according to the electromyographic signal.

In an embodiment of the present invention, when the second stimulation electrode stops applying the second electrical stimulation signal, the electromyographic recording electrode records the electromyographic signal.

In one embodiment of the invention, the motor roots of the anterior spinal cord are located on one or both sides of any one or more of the spinal segments from the C-segment of the cervical medulla to the S-segment of the sacral medulla.

In one embodiment of the invention, the spinal cord posterior root sensory nerve roots are located on one or both sides of any one or more of the spinal segments from the cervical C-segment to the sacral S-segment.

In an embodiment of the invention, the electrical stimulation unit further comprises at least one recovery electrode implanted subcutaneously in the back of the patient, the recovery electrode being configured to cooperate with the first stimulation electrode and/or the second stimulation electrode in a monopolar stimulation mode.

In an embodiment of the invention, the first and/or second stimulation electrodes comprise carbon nanotube fibre electrodes having a diameter in the range of 100nm to 100 μm.

In an embodiment of the present invention, the first electrical stimulation signal is a negative-first followed by a positive charge-balanced biphasic pulse.

In an embodiment of the invention, the second electrical stimulation signal is a high frequency sinusoidal alternating current signal and/or a high frequency pulsed signal.

In an embodiment of the invention, the stimulation parameters comprise the frequency, amplitude and individual pulse width of the stimulation pulses.

In an embodiment of the invention, the frequency range of the stimulation pulses of the first electrical stimulation signal is 0.5Hz to 10kHz, and the single pulse width is in the range of 0.02 to 10ms.

In an embodiment of the invention, the frequency of the stimulation pulses of the second electrical stimulation signal is in the range of 0.01kHz to 100kHz, and the individual pulse width is in the range of 0.02 to 10ms.

In one embodiment of the invention, the amplitude comprises a current amplitude in the range of 0.2 μ Α to 20mA.

The invention also provides an electrical stimulation regulation and control method for abnormal muscle tension of a spastic cerebral palsy patient, which aims to solve the technical problems and comprises the following steps: recording an electrical signal generated by at least one spinal cord anterior root motor root; applying a first electrical stimulation signal to the at least one spinal cord anterior root motor root; and controlling stimulation parameters of the first electrical stimulation signal according to the electrical signal.

In one embodiment of the present invention, the method includes: applying a second electrical stimulation signal to at least one of the posterior spinal root sensory nerve roots to inhibit afferent perception of sensory signals.

In an embodiment of the present invention, the method further includes: recording electromyographic signals of a limb of a patient; and controlling the stimulation parameter of the second electrical stimulation signal according to the electromyographic signal.

In an embodiment of the present invention, the step of controlling the stimulation parameter of the first electrical stimulation signal according to the electrical signal comprises: and extracting the active motor nerve signal emitted by the brain from the electric signal, and controlling the stimulation parameter of the first electric stimulation signal to amplify the active motor nerve signal.

In one embodiment of the present invention, the step of extracting the active motor signal from the electrical signal comprises: and when the change rate of the electric signal exceeds a preset threshold value, judging the electric signal as an active motor nerve signal.

In an embodiment of the present invention, when the electrical signal of at least one spinal cord anterior root motor root is determined to be an active motor signal, the first electrical stimulation signal is applied to the at least one spinal cord anterior root motor root.

In an embodiment of the present invention, the method further includes: when the application of the second electrical stimulation signal is stopped, the electromyographic signal is recorded.

In one embodiment of the present invention, the electrical signals of at least one spinal cord anterior root motor nerve root are recorded while applying the second electrical stimulation signal to at least one spinal cord posterior root sensory nerve root.

The electrical stimulation regulation and control device and method for muscle tension abnormality of spastic cerebral palsy patients have the advantages of small wound and adjustable parameters. Compared with the SDR operation type, the electrical stimulation regulation and control device provided by the invention has the advantages that the nerve root does not need to be cut off, the irreversible damage caused by the SDR operation type is avoided, and the injury to a patient is reduced. And closed-loop control can be realized after the electrode is implanted, the purpose of personalized treatment is achieved by regulating and controlling stimulation parameters, and the muscle spasm symptom of a patient can be effectively improved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the principle of the invention. In the drawings:

fig. 1 is a block diagram of an electrical stimulation regulation device according to an embodiment of the present invention;

fig. 2 is a schematic view of a state of the electrical stimulation control device according to the first embodiment of the present invention in use;

3A-3D show schematic diagrams of 4 different implantable electrodes;

fig. 4 is a schematic view of the electrical stimulation regulation and control device according to the second embodiment of the present invention in a use state;

FIG. 5 is a schematic view of the electrical stimulation control device according to the third embodiment of the present invention in use;

FIG. 6A is a schematic diagram of an electrical stimulation modulation device according to an embodiment of the present invention, which employs a monopolar stimulation mode;

fig. 6B is a schematic diagram of an electrical stimulation regulation device according to an embodiment of the present invention, which employs a bipolar stimulation mode;

fig. 7A is a schematic diagram of the working timing sequence of the first stimulating electrode and the recording electrode in the electrical stimulation control apparatus according to the first embodiment of the present invention;

fig. 7B is a schematic diagram of the working timing sequence of the second stimulation electrode and the electromyography electrode in the electrical stimulation regulation and control device according to the second embodiment of the present invention;

fig. 7C is a schematic diagram of the working timing of the stimulating electrode and the recording electrode in the electrical stimulation control apparatus according to the third embodiment of the present invention;

FIG. 8 is a flowchart illustrating an electrical stimulation modulation method for muscle tension abnormality of a spastic cerebral palsy patient according to a first embodiment of the present invention;

FIG. 9 is a flowchart illustrating an electrical stimulation modulation method for muscle tension abnormality of a spastic cerebral palsy patient according to a first embodiment of the present invention;

FIG. 10 is a flowchart illustrating an exemplary method for controlling muscular dystonia in a spastic cerebral palsy patient according to a second embodiment of the present invention;

fig. 11 is an exemplary flowchart of an electrical stimulation regulation method for abnormal muscle tension of a spastic cerebral palsy patient according to a third embodiment of the present invention.

Detailed Description

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only examples or embodiments of the application, from which the application can also be applied to other similar scenarios without inventive effort for a person skilled in the art. Unless otherwise apparent from the context, or otherwise indicated, like reference numbers in the figures refer to the same structure or operation.

As used in this application and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements.

The relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present application unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as exemplary only and not as limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

In the description of the present application, it is to be understood that the directions or positional relationships indicated by the directional terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal" and "top, bottom", etc., are generally based on the directions or positional relationships shown in the drawings, and are for convenience of description and simplicity of description only, and in the case of not making a reverse description, these directional terms do not indicate and imply that the device or element being referred to must have a particular orientation or be constructed and operated in a particular orientation, and therefore should not be construed as limiting the scope of the present application; the terms "inner and outer" refer to the inner and outer relative to the profile of the respective component itself.

It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and the terms have no special meanings unless otherwise stated, and therefore, the scope of protection of the present application is not to be construed as being limited. Further, although the terms used in the present application are selected from publicly known and used terms, some of the terms mentioned in the specification of the present application may be selected by the applicant at his or her discretion, the detailed meanings of which are described in relevant parts of the description herein. Further, it is required that the present application is understood not only by the actual terms used but also by the meaning of each term lying within.

Flow charts are used herein to illustrate operations performed by systems according to embodiments of the present application. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, various steps may be processed in reverse order or simultaneously. Meanwhile, other operations are added to or removed from these processes.

The electrical stimulation regulation and control device can implant the relevant stimulation electrode into the spastic cerebral palsy patient body through a minimally invasive surgery, the recording electrode can be implanted into the patient body or arranged on the body surface of the patient, a control unit in the device can be implanted into the patient body or arranged outside the patient body, and the control unit can control the actions of the stimulation electrode and the recording electrode in a wired or wireless mode. It can be understood that the electrical stimulation regulation and control device at least further comprises a power supply, a switch and other elements, and the invention does not limit the position and the type of the power supply, the switch and other elements.

Fig. 1 is a block diagram of an electrical stimulation control device according to an embodiment of the present invention. Referring to fig. 1, the electrostimulation regulating device 100 of this embodiment includes an electrostimulation unit 110, and a control unit 120. Wherein, the electrical stimulation unit 110 includes at least one stimulation electrode disposed in or outside the fascicles of at least one target nerve root for applying an electrical stimulation signal to at least one target spinal anterior motor root; the control unit 120 is used to control stimulation parameters of the electrical stimulation signal.

The invention does not limit the number of the stimulating electrodes and the specific position of the target nerve root.

In some embodiments, the target nerve root comprises a spinal cord anterior root motor nerve root and/or a spinal cord posterior root sensory nerve root.

According to the electrical stimulation regulation and control device, the stimulation electrode is implanted into the fasciculus or out of the fasciculus of the target nerve root, can directly stimulate the related target nerve root, and has stronger accuracy and effectiveness compared with the common electrical stimulation mode of implanting the stimulation electrode into subcutaneous tissue.

Referring to fig. 1, in the first embodiment, the electrical stimulation regulation and control device 100 further includes a recording unit 130, wherein the stimulation electrodes include a first stimulation electrode, the target nerve root is a spinal anterior motor root, the electrical stimulation signal includes a first electrical stimulation signal, the first stimulation electrode is disposed in or out of a bundle of at least one spinal anterior motor root, and the first stimulation electrode is configured to apply the first electrical stimulation signal to at least one spinal anterior motor root; the recording unit 130 includes at least one recording electrode, which is disposed in or outside the fasciculus of at least one anterior spinal motor root and is used for recording the electrical signal generated by at least one anterior spinal motor root; the control unit 120 is configured to control the recording timing of the recording electrode and to control the stimulation parameters of the first electrical stimulation signal in dependence on the electrical signal.

In the second embodiment, the stimulation electrode includes a second stimulation electrode, the target nerve root includes a spinal cord posterior root sensory nerve root, the electrical stimulation signal includes a second electrical stimulation signal, the second stimulation electrode is disposed within or outside the at least one spinal cord posterior root sensory nerve root, the second stimulation electrode is configured to apply the second electrical stimulation signal to the at least one spinal cord posterior root sensory nerve root to inhibit afferent of the sensory signal; the control unit 120 is configured to control the stimulation parameters of the second electrical stimulation signal.

In the third embodiment, the stimulation electrodes include a first stimulation electrode and a second stimulation electrode, wherein the first stimulation electrode is disposed in or outside the fasciculus of at least one anterior spinal cord motor root, the first stimulation electrode is used for applying a first electrical stimulation signal to at least one anterior spinal cord motor root, the second stimulation electrode is disposed in or outside the fasciculus of at least one posterior spinal cord sensory nerve root, the second stimulation electrode is used for applying a second electrical stimulation signal to at least one posterior spinal sensory nerve root to suppress the afferent of the sensory signals, the control unit 120 is used for controlling the recording time of the recording electrodes and controlling the stimulation parameters of the first electrical stimulation signal according to the electrical signals, and the control unit 120 is further used for controlling the stimulation parameters of the second electrical stimulation signal.

Different embodiments of the electrical stimulation control device 100 are described below with reference to fig. 2 to 7C.

Fig. 2 is a schematic view of a state of the electrical stimulation control device according to the first embodiment of the present invention in use. Referring to fig. 2, a segment of a human spinal cord 210 is shown, with the front of the spinal cord 210 facing the reader in fig. 2 being the ventral side of the human body, and the back of the spinal cord 210 being the dorsal side of the human body. The anterior motor 220 is ventrally connected to the body 211 of the spinal cord 210, and the posterior sensory 230 is dorsal connected to the body 211 of the spinal cord 210. Also, anterior motor nerves 220 and posterior sensory nerves 230 are symmetrically distributed on the left and right sides of the spinal cord 210. Wherein the anterior root motor nerve 220 is an efferent nerve used to generate and control the movement and tone of the body; the sensory nerve 230 is an afferent nerve that receives stimuli sensed by body receptors and produces an excitation that is converted into nerve impulses that afferent the center to cause a sensation or reflex. As shown in fig. 2, the anterior motor nerve 220 is a single ventral nerve and is divided into multiple bundles near the spinal cord 210, each bundle being connected to the main body 211 of the spinal cord 210, and the bundles are also called nerve roots. Similarly, the posterior root sensory nerve 230 also includes a plurality of nerve roots that are connected to the main body 211 of the spinal cord 210.

In the embodiment shown in fig. 2, a first stimulation electrode 240 of the electrical stimulation unit 110 is disposed in the tract of an anterior spinal motor root 221, and a recording electrode 250 of the recording unit 130 is also disposed in the tract of the anterior spinal motor root 221. The front ends of the first stimulation electrode 240 and the recording electrode 250 are located at different positions within the bundle of anterior spinal motor roots 221. As shown in fig. 2, the leading end 241 of the first stimulating electrode 240 is relatively close to the spinal cord 210, and the leading end 251 of the recording electrode 250 is relatively far from the spinal cord.

The present invention is not limited to the specific locations of the leading ends 241, 251 of the first stimulating electrode 240 and the recording electrode 250.

In the embodiment shown in fig. 2, a first stimulating electrode 240 and a recording electrode 250 are disposed within the same anterior spinal motor root 221 tract.

In some embodiments, the anterior spinal motor roots on which the first stimulation electrode 240 and recording electrode 250 are located on one or both sides of the spinal segment from any one or more of the cervical C-segment to the sacral S-segment. It is understood that a first stimulating electrode and a recording electrode may be implanted in each of the anterior spinal motor roots, and the number of implanted electrodes is not limited by the present invention. The physician may perform an intraoperative neurophysiological test by selecting the appropriate anterior spinal motor root as the subject for implantation of the first stimulation electrode 240 and recording electrode 250.

In other embodiments, the first stimulation electrode 240 and/or recording electrode 250 may be disposed outside the fascicles of the anterior spinal motor roots 221. The invention is not limited with respect to the particular form of the implantable electrodes as the first stimulating electrode 240 and the recording electrode 250. The implantable electrodes may include Cuff electrodes, wrap around electrodes, longitudinal intrabundle Multichannel electrodes (LIFE), transverse Intrabundle Multichannel Electrodes (TIME), and the like.

Fig. 3A-3D show schematic diagrams of 4 different implantable electrodes. Fig. 3A shows a LIFE electrode 310 implanted in a nerve root 301; FIG. 3B shows a TIME electrode 311 implanted in a nerve root 301; FIG. 3C shows a Cuff-type electrode 312 wrapped around the nerve root 301; fig. 3D shows a flexible electrode 313 wound around the nerve root 301. FIGS. 3A and 3B both show implantable electrodes that may be positioned within the nerve bundle, and FIGS. 3C and 3D show implantable electrodes positioned outside the nerve bundle. Fig. 3A-3D illustrate examples, and any type of implantable electrode may be used.

In some embodiments, the material of the implantable electrode may be selected from gold (Au), platinum (Pt), platinum-iridium alloy (Pt-Ir), iridium oxide (IrO) _x ) Titanium (Ti), titanium oxide (TiO) ₂ ) Nitrogen, nitrogenTitanium (Ti) _x N _y ) Carbon nanotubes (Carbon nanotubes), silicon (Si), and other conductive polymers, and the like.

In some embodiments, the base material of the implantable electrode may be selected from Polyimide (PI), parylene (Parylene), polydimethylsiloxane (PDMS), SU-8 photoresist, and the like.

In some embodiments, the first stimulation electrode 240 is disposed within the fascicles of the anterior spinal motor roots 221 and the recording electrode 250 is disposed outside the fascicles of the anterior spinal motor roots 221, or vice versa.

According to the electrical stimulation regulation and control device shown in fig. 2, the recording electrode 250 records the electrical signal of the motor nerve root 221 of the anterior spinal cord in real time, and the stimulation parameter of the first stimulation electrode 240 is adjusted according to the electrical signal, so as to further induce the motor nerve root 221 of the anterior spinal cord to emit action potential, so that the excitability of motor nerve fiber can be enhanced, and the motor signal transmitted from the anterior motor nerve 220 can be enhanced, thereby being beneficial to improving the abnormal muscle tension of patients with spastic cerebral palsy and enhancing the active control capability of the patients on muscles.

In some embodiments, the control unit 120 extracts the active motor nerve signal emitted from the brain from the electrical signal and controls the stimulation parameter of the first electrical stimulation signal such that the active motor nerve signal is amplified. Active signals emitted from the brain to the muscles of a spastic cerebral palsy patient are weakened, so that the patient cannot actively control the muscles. The electrical stimulation regulation and control device 100 of the present invention obtains the recorded electrical signal from the recording unit 130 through the control unit 120, analyzes the electrical signal, extracts the active motor nerve signal of the brain therefrom, electrically stimulates the anterior root motor nerve root 221 of the spinal cord through the first stimulation electrode 240, and further induces the issuance of an action potential, thereby enhancing the excitability of the anterior root motor nerve 220, enhancing the transmission of the active motor nerve signal, and being beneficial to improving the active control of the patient on abnormal muscle tension muscles.

In some embodiments, when the control unit 120 determines that the electrical signal is an active motor signal, the control unit 120 controls the first stimulation electrode to deliver the first electrical stimulation signal. According to these embodiments, the recording electrode continuously records the electrical signal of the motor root of the anterior spinal root after the first stimulation electrode and the recording electrode are implanted in the patient, and the control unit 120 controls the first stimulation electrode to deliver the first electrical stimulation signal when the active motor signal is detected from the electrical signal.

In some embodiments, when the rate of change of the electrical signal exceeds a preset threshold, the control unit 120 determines that the electrical signal is an active motor signal.

The present investigators have found that when the electrical signal recorded by the recording electrode 250 at the motor root 221 of the anterior spinal cord suddenly increases, it indicates that the brain sends an active motor signal. Therefore, in these embodiments, the rate of change of the electrical signal is obtained from the change characteristics of the electrical signal.

In some embodiments, the rate of change of the electrical signal is a rate of change of an amplitude of the electrical signal over time. In some cases, when the brain emits an active motor signal, the recorded electrical signal may fluctuate in amplitude by a large amount, including both positive and negative fluctuations, as represented by an increase in the absolute value of the amplitude of the electrical signal, and thus, the rate of change refers to the rate of change in the absolute value of the electrical signal. At this time, the preset threshold value corresponds to a rate of change of the amplitude of the electric signal with time.

In some embodiments, the rate of change of the electrical signal is the rate of change of the frequency of the electrical signal over time. In some cases, when the brain emits an active motor signal, the frequency of spike signals emitted from neurons in the recorded electrical signal is suddenly increased, and whether the brain emits the active motor signal can be determined by analyzing the frequency change of the electrical signal. At this time, the preset threshold corresponds to a rate of change of the frequency of the electric signal with time.

The specific calculation method of the change rate of the electrical signal is not limited by the invention. For example, taking the time rate of change as an example, a differential signal in which the electrical signal changes gradually with time may be calculated, and the differential signal is not limited to the first order difference, and may include a second order difference, a multi-order difference, and the like. When the current electrical signal suddenly increases, the rate of change of the absolute value of the current electrical signal compared to the previous historical electrical signal is positive, indicating that the current electrical signal has increased in amplitude compared to the historical electrical signal.

After applying the electrical stimulus through the first stimulation electrode 240, the present electrical signal is further amplified, as shown by an amplification of the absolute value of the amplitude of the electrical signal, or an increase in the frequency of the electrical signal.

In some embodiments, the electrical stimulation unit 110 of the electrical stimulation regulation and control device 100 shown in fig. 1 includes at least one second stimulation electrode disposed inside or outside the fasciculus of at least one of the spinal posterior root sensory nerve roots, the second stimulation electrode being configured to apply a second electrical stimulation signal to the at least one of the spinal posterior root sensory nerve roots to suppress afferent sensory signals; the control unit is further configured to control a stimulation parameter of the second electrical stimulation signal.

Fig. 4 is a schematic view of a state of the electrical stimulation control device according to the second embodiment of the present invention in use. Referring to fig. 4, the spinal cord 210, the main body 211 of the spinal cord 210, the anterior motor nerve 220, and the posterior sensory nerve 230 are the same as in the embodiment of fig. 2, and therefore have the same reference numerals. In the embodiment shown in fig. 4, a second stimulation electrode 410 is disposed within the tract of a spinal cord posterior root sensory nerve root 231, as shown in fig. 4, the front end 411 of the second stimulation electrode 410 is located approximately at the junction of the spinal cord posterior root sensory nerve root 231 and the main body 211 of the spinal cord 210.

The embodiment shown in fig. 4 is not intended to limit the specific location and number of second stimulation electrodes 410.

In some embodiments, the posterior spinal root sensory nerve roots on which the second stimulation electrode 410 is disposed are located on one or both sides of any one or more of the spinal segments from the cervical spinal C segment to the sacral spinal S segment. It is to be understood that a second stimulation electrode may be implanted in each of the posterior root sensory nerve roots of the spinal cord, and the number of implanted electrodes is not limited by the present invention. The physician may perform an intraoperative neuroelectrophysiological test by selecting the appropriate spinal cord posterior root sensory nerve root as the subject for implantation of the second stimulation electrode 410.

The second stimulation electrode 410 may also employ any of the implantable electrodes shown in figures 3C-3D.

The present invention is not limited to whether the first stimulating electrode 240, the recording electrode 250, and the second stimulating electrode 410 are the same implantable electrode.

According to the embodiment shown in fig. 4, the second electrical stimulation signal is applied to the sensory nerve root 231 of the spinal cord via the second stimulation electrode 410, so that the sensory signal of the sensory nerve root 231 of the spinal cord can be inhibited from transmitting to the brain, the excitation signal transmitted by the sensory nerve of the dorsal root in the muscle tension signal is weakened, the pain of muscles and joints is relieved, and the muscle spasm phenomenon of the patient is improved.

Fig. 5 is a schematic view of the state of the electrical stimulation control device in the third embodiment of the present invention when in use. Referring to fig. 5, this embodiment combines the first and second embodiments, and the stimulation electrodes include both the first stimulation electrode 240 and the second stimulation electrode 410, which are disposed at the same positions and functions as those described in the first and second embodiments, respectively, and will not be further described herein. Meanwhile, the control unit 120 is also configured to control stimulation parameters of the first electrical stimulation signal and the second electrical stimulation signal at the same time. According to the third embodiment, the motor nerve root 221 of the anterior spinal cord root and the sensory nerve root 231 of the posterior spinal cord root are stimulated and controlled simultaneously, and are used together for improving the abnormal muscle tension of the spastic cerebral palsy patient.

In some embodiments, the electrical stimulation conditioning device 100 of the present invention further comprises at least one electromyography electrode disposed on the surface of a limb of the patient or in the subcutaneous musculature of the limb of the patient, the electromyography electrode being for recording electromyography signals; the control unit is also used for controlling the recording time of the electromyographic recording electrode and controlling the stimulation parameter of the second electrical stimulation signal according to the electromyographic signal.

The invention does not limit the concrete electrode form of the electromyographic recording electrode. When the electromyographic recording electrodes are disposed on the surface of a patient's limb, surface electrodes may be employed; implanted electrodes may be used when the electromyographic recording electrodes are disposed in subcutaneous muscle tissue of a limb of a patient. Before operation, a doctor can determine the arrangement position of the electromyographic recording electrode according to the muscle position with abnormal muscle tension. The electromyographic signals are associated with an improvement in the muscle tone of the patient. After implanting the second stimulation electrode 410, the control unit 120 acquires the electromyographic signals from the recording unit 130, analyzes the electromyographic signals and adjusts the stimulation parameters of the second electrical stimulation signal to form a closed loop adjustment pattern to encourage the patient's muscle tone to progress in an improved direction.

The present invention is not limited to a specific manner of applying the electrical stimulation to the first stimulation electrode and the second stimulation electrode.

In some embodiments, a monopolar stimulation mode is employed. In some embodiments, a bipolar stimulation mode is employed.

In the monopolar stimulation mode, the electrical stimulation unit 110 further comprises at least one retrieval electrode implanted subcutaneously on the patient's back for cooperation with the first stimulation electrode and/or the second stimulation electrode in the monopolar stimulation mode. Recovery electrodes may be included in each of the previously described embodiments one, two, and three for use in a monopolar stimulation mode.

Fig. 6A is a schematic diagram of an electrical stimulation modulation apparatus according to an embodiment of the present invention, which employs a monopolar stimulation mode. Referring to fig. 6A, the recovery electrode 510 is implanted under the skin 520. The nerve root 530 shown in fig. 6A may be a spinal cord anterior root motor nerve root or a spinal cord posterior root sensory nerve root in which a plurality of

stimulation electrodes

541, 542, 543 are implanted. The

stimulation electrodes

541, 542, 543 are first stimulation electrodes corresponding to the motor roots of the anterior spinal cord; the

stimulation electrodes

541, 542, 543 are second stimulation electrodes corresponding to the sensory nerve roots of the posterior spinal root. In fig. 6A, the stimulation electrode 541 is connected to the electrical stimulation unit 110 through a lead 544, and the recovery electrode 510 is connected to the electrical stimulation unit 110 through a lead 511, so that an electrical stimulation pulse signal is applied between the stimulation electrode 541 and the recovery electrode 510 as a first electrical stimulation signal or a second electrical stimulation signal.

Fig. 6B is a schematic diagram of an electrical stimulation regulation device according to an embodiment of the present invention, which adopts a bipolar stimulation mode. Referring to fig. 6B, the nerve root 620 may be a motor root of the anterior spinal cord or a sensory nerve root of the posterior spinal cord, in which a plurality of

stimulation electrodes

611, 612, 613 are implanted, each of which is connected to the electrical stimulation unit 110 through a lead, and in the bipolar stimulation mode, the electrical stimulation unit 110 may control the application of an electrical stimulation pulse signal between any two stimulation electrodes as the first electrical stimulation signal or the second electrical stimulation signal without providing a recovery electrode.

In some embodiments, the first stimulation electrode and/or the second stimulation electrode comprise carbon nanotube fiber electrodes having a diameter in a range of 100nm to 100 μm. The carbon nanotube fiber electrode has an exposed length of 0 micron (cross section exposed) to 5mm, and can focus on more local nerve tissues when recording and stimulating nerve electrical signals, and has excellent spatial selectivity. The carbon nanotube fiber electrode insulation layer is preferably PDMS and C-Parylene, and the thickness of the insulation layer is 1 μm to 10 μm. The thinner the thickness of the insulating layer, the smaller the outer diameter of the entire carbon nanotube wire, and the less damage to the tissue after implantation.

In the embodiment of the present invention, the waveform of the electrical stimulation pulse signal emitted by the electrical stimulation unit 110 may be a sine wave, a triangle wave, a square wave, a sawtooth wave, a trapezoid wave, an exponential wave, a charge balance type biphasic pulse, etc.

In some embodiments, the first electrical stimulation signal is a negative-first then positive charge-balanced biphasic pulse.

In some embodiments, the second electrical stimulation signal is a high frequency sinusoidal alternating current signal and/or a high frequency pulsed signal. High frequency means that the frequency range of the sinusoidal alternating current signal and the pulse signal is 0.01kHz to 100kHz.

In some embodiments, the stimulation parameters of the first and second electrical stimulation signals include the frequency, amplitude, and individual pulse width of the stimulation pulses. The frequency range of the stimulation pulses of the first electrical stimulation signal is 0.5Hz to 10kHz, and the individual pulse width ranges from 0.02 to 10ms. The frequency of the stimulation pulses of the second electrical stimulation signal is in the range of 0.01kHz to 100kHz and the individual pulse width is in the range of 0.02 to 10ms. The amplitudes include current amplitudes, and the current amplitudes of the first and second electrical stimulation signals range from 0.2 μ Α to 20mA.

Fig. 7A is a schematic diagram of the working timing of the first stimulating electrode and the recording electrode in the electrical stimulation regulating device according to the first embodiment of the present invention. Referring to fig. 7A, T1 represents the time period for the recording electrode to record the electrical signal generated by at least one anterior spinal motor root, and T2 represents the time period for the first stimulation electrode to apply the first electrical stimulation signal to at least one anterior spinal motor root. Note that the high level shown by the square wave in fig. 7A to 7C indicates the operating state, and the low level indicates the stop state. The illustrations of fig. 7A-7C are merely examples and are not intended to limit the form and timing relationships of actual electrical stimulation pulses.

The operational sequence shown in FIG. 7A corresponds to the first embodiment shown in FIG. 2, wherein the duration of T2 is determined based on the identified active motor signals, approximately in the range of 10ms to 2 h. While the first stimulation electrode applies the first electrical stimulation signal, the recording electrode continues to record the electrical signal for a period of time indicated by T1. It is understood that the control unit 120 may filter the first electrical stimulation signal from the electrical signal according to the signal characteristics and extract the active motor signal from the electrical signal. According to the timing shown in fig. 7A, the control unit 120 detects an active motor signal from the electrical signal, and controls the first stimulation electrode to deliver the first electrical stimulation signal T2 for a duration to amplify the active motor signal when the active motor signal is detected. After a period of time T2, the first stimulation electrode is controlled to stop delivering the first electrical stimulation signal until the next time an active motor signal is detected. It should be noted that the length I1 of the idle period between the T2 periods in fig. 7A may be equal or different.

Fig. 7B is a schematic diagram of the working timing of the second stimulation electrode and the electromyographic recording electrode in the electrical stimulation regulation and control device according to the second embodiment of the present invention. Referring to fig. 7B, T3 represents a collection time period during which the electromyographic recording electrode records the electromyographic signals, and T4 represents an electrical stimulation duration time period during which the second stimulation electrode applies the second electrical stimulation signal to at least one sensory nerve root of the spinal cord. The operation sequence shown in fig. 7B corresponds to the second embodiment shown in fig. 4.

In the embodiment shown in fig. 7B, the electromyographic recording electrode records the electromyographic signal when the second stimulation electrode stops applying the second electrical stimulation signal. As shown in fig. 7B, T3 and T4 have no overlapping part, which indicates that after the second stimulation electrode delivers the second electrical stimulation signal for a time period T4, the electromyographic signal of the time period T3 is collected, the control unit 120 determines whether the stimulation parameter of the current second electrical stimulation signal needs to be adjusted according to the electromyographic signal, and after the adjustment, the second electrical stimulation signal is continuously delivered again.

Fig. 7C is a schematic diagram of the working timing of the stimulating electrode and the recording electrode in the electrical stimulation regulation and control device according to the third embodiment of the present invention. Referring to fig. 7C, T1 and T2 have the same meanings as T1 and T2 shown in fig. 7A, T3 and T4 have the same meanings as those shown in fig. 7B, and the operation sequence shown in fig. 7C corresponds to the third embodiment shown in fig. 5.

According to the embodiment shown in fig. 7C, when the electromyographic signals are recorded at the time period T3, the first stimulation electrode and the second stimulation electrode do not work, so that the electromyographic signals are not interfered by the electrical stimulation signals, the phenomenon that artifacts are mixed in the electromyographic signals is avoided, the electromyographic signals are analyzed, and accurate analysis results are obtained quickly; meanwhile, the non-overlapping of T3 and T4 can reduce the energy consumption of the battery to a certain extent.

In some embodiments, the electromyographic recording electrode continuously records the electromyographic signal, the control unit 120 determines whether the electromyographic signal is abnormal, and when the electromyographic signal is abnormal, the control unit 120 controls the second stimulation electrode to send the second electrical stimulation signal and enables the second electrical stimulation signal to last for a time period of T4. In these embodiments, the duration of T3 is not limited and, with reference to fig. 7B and 7c, T3 and T4 may overlap. In order to obtain the electromyographic signals and to judge the electromyographic improvement condition, a signal processing method may be employed to filter out interference from the electromyographic signals from the second electrical stimulation signal and the like. In some cases, the duration of T4 is between a few minutes to a few hours, or even longer. The electromyographic recording electrode can start to record the electromyographic signals when the electric stimulation regulation and control device is started, and the recording is finished when the electric stimulation regulation and control device is closed.

As shown in fig. 7C, in this embodiment, the collecting time period T1 of the recording electrode is different from that shown in fig. 7A, and after the recording electrode collects the electric signal for a time period T1, the collecting is stopped for a certain time period, and then the collecting is started. The first stimulation electrode does not apply the first electrical stimulation signal during the period when the recording electrode stops acquiring the electrical signal. The time interval T1 corresponds to the time interval T4, that is, while the second stimulation electrode applies the second electrical stimulation signal to the sensory nerve roots of the posterior spinal root, the recording electrode is used to collect the electrical signals of the motor nerve roots of the anterior spinal root, and when the second stimulation electrode stops sending the second electrical stimulation signal, the recording electrode also stops collecting the electrical signals of the motor nerve roots of the anterior spinal root. The recording electrode records an electric signal within a time length T1, when the control unit 120 judges that the electric signal is an active motor nerve signal, the first stimulation electrode applies a first electric stimulation signal to amplify the active motor nerve signal, after the electric stimulation lasts for 1T 2 time period, the first stimulation electrode stops applying the first electric stimulation signal, and when the control unit 120 detects the active motor nerve signal from the electric signal again, the first stimulation electrode sends the first electric stimulation signal for a time length T2 again.

According to the embodiment shown in fig. 7C, the electrical stimulation to the motor roots of the anterior spinal cord roots and the electrical stimulation to the sensory nerve roots of the posterior spinal cord are combined, the motor signals of the anterior spinal cord roots are amplified, simultaneously the afferent signals of the sensory nerve roots of the posterior spinal cord roots are inhibited, and under the comprehensive action of the two signals, the control capability of the motor functions of the muscles of the patient on the active signals of the brain is enhanced, the muscle tension of the patient is weakened, and the problem of abnormal muscle tension of the patient is bidirectionally improved.

The electrical stimulation regulation and control device for the muscle tension abnormality of the spastic cerebral palsy patient has the advantages of small wound and adjustable parameters. Compared with the SDR operation type, the electrical stimulation regulation and control device provided by the invention has the advantages that the nerve root does not need to be cut off, the irreversible damage caused by the SDR operation type is avoided, and the injury to a patient is reduced. And closed-loop control can be realized after the electrode is implanted, the purpose of personalized treatment is achieved by regulating and controlling stimulation parameters, and the muscle spasm symptom of a patient can be effectively improved.

Fig. 8 is an exemplary flowchart of an electrical stimulation regulation method for abnormal muscle tension of a spastic cerebral palsy patient according to a first embodiment of the present invention. Referring to fig. 8, the electrical stimulation regulation method of this embodiment includes the steps of:

step S810: recording an electrical signal generated by at least one spinal cord anterior root motor nerve root;

step S820: applying a first electrical stimulation signal to at least one spinal cord anterior motor root to cause the at least one spinal cord anterior motor root to generate an electrical signal; and

step S830: the stimulation parameters of the first electrical stimulation signal are controlled according to the electrical signal.

The electrical stimulation regulation method of the present invention may be performed using the electrical stimulation regulation apparatus described above. The foregoing description and drawings may be used to illustrate the electrical stimulation modulation method of the present invention and the same is not repeated.

For example, step S810 is performed using the first stimulation electrode in the electrical stimulation unit, step S820 is performed using the recording electrode in the recording unit, and step S830 is performed using the control unit.

In some embodiments, step S830 in the method includes: and extracting the active motor nerve signal emitted by the brain from the electric signal, and controlling the stimulation parameter of the first electric stimulation signal to amplify the active motor nerve signal.

Further, the step of extracting the active motor signal from the electrical signal includes: and when the change rate of the electric signal exceeds a preset threshold value, judging the electric signal as an active motor nerve signal.

In some embodiments, the first electrical stimulation signal is applied to at least one anterior spinal motor root when the electrical signal of the at least one anterior spinal motor root is determined to be an active motor signal. The frequency range of the stimulation pulses of the first electrical stimulation signal is 0.5Hz to 10kHz and the individual pulse width ranges from 0.02 to 10ms.

In some embodiments, the methods of modulation of electrical stimulation of the present invention comprise:

step S840: applying a second electrical stimulation signal to at least one of the spinal cord posterior root sensory nerve roots to inhibit afferent sensory signals.

In some embodiments, the method further comprises:

step S850: recording electromyographic signals of a limb of a patient;

step S860: and controlling the stimulation parameter of the second electrical stimulation signal according to the electromyographic signal. The frequency range of the stimulation pulses of the second electrical stimulation signal is 0.01kHz to 100kHz.

In some embodiments, the electrical stimulation regulation method of the present invention includes steps S810 to S830 and steps S840 to S860.

In some embodiments, the stimulation parameters of the first and second electrical stimulation signals include the frequency, amplitude, and individual pulse width of the stimulation pulses. The amplitudes include current amplitudes, and the current amplitudes of the first and second electrical stimulation signals range from 0.2 μ Α to 20mA.

In some embodiments, the recording electrode continuously records the electrical signals generated by at least one anterior spinal motor root; the electromyographic recording electrodes continuously record electromyographic signals.

In some embodiments, step S850 includes: when the application of the second electrical stimulation signal is stopped, the electromyographic signal is recorded.

In some embodiments, electrical signals of at least one spinal cord anterior root motor nerve root are recorded while applying the second electrical stimulation signal to at least one spinal cord posterior root sensory nerve root.

Fig. 9 is an exemplary flowchart of an electrical stimulation control method for muscle tension abnormality of a spastic cerebral palsy patient according to a first embodiment of the present invention. In combination with the electrical stimulation regulation and control device described in fig. 2, the electrical stimulation regulation and control method of this embodiment includes the following steps:

step S910: a first stimulating electrode and a recording electrode are implanted in the anterior spinal motor roots. The first stimulating electrode and the recording electrode here may be the first stimulating electrode 240 and the recording electrode 250 shown in fig. 2.

Step S920: and acquiring and recording the electric signal in real time. This step may be performed by the recording electrode 250.

Step S930: and judging whether the active motor nerve signal is detected. This step may be performed by the control unit 120 as described above, with reference to the method of detection and determination being required. If yes, go to step S940; if not, go to step S920.

Step S940: the active motor signals are analyzed and stimulation parameters are set. This step may be performed by the control unit 120 as described above. Analyzing the active motor signal may include comparing the degree of change of the active motor signal, and if the active motor signal is not significantly increased under the current stimulation parameter, adjusting the stimulation parameter to enhance the stimulation intensity of the first electrical stimulation signal.

Step S950: a first electrical stimulation signal is applied. In this step, the stimulation parameters of the first electrical stimulation signal are determined by the control unit 120 in step S940.

Step S960: after the time period T2 elapses, the first electrical stimulation signal stops being delivered, and the step S920 is continuously executed.

As shown in connection with FIG. 7A, steps S910-S960 may be performed following the timing sequence shown in FIG. 7A.

Fig. 10 is an exemplary flowchart of an electrical stimulation regulation method for abnormal muscle tension of a spastic cerebral palsy patient according to a second embodiment of the present invention. In combination with the electrical stimulation regulation and control device described in fig. 4, the electrical stimulation regulation and control method of this embodiment includes the following steps:

step S1010: implanting a second stimulating electrode in the sensory nerve root of the posterior root of the spinal cord, and implanting an electromyographic recording electrode on the body surface or in the muscle. The second stimulation electrode here may be the second stimulation electrode 410 shown in fig. 4.

Step S1020: a second electrical stimulation signal is applied. The second electrical stimulation signal may have default stimulation parameters.

Step S1030: and judging whether the muscle tension of the patient is improved or not according to the EMG signal. An EMG signal is an electromyographic signal recorded by an electromyographic recording electrode. This step may be performed by the control unit 120. If yes, go to step S1040; if no, go to step S1050.

Step S1040: the second electrical stimulation signal is continuously delivered while continuing to determine whether the patient's muscle tone is improving based on the EMG signal. The duration of the continuous delivery of the second electrical stimulation signal is dependent upon the improvement in the EMG signal.

Step S1050: the stimulation parameters of the second electrical stimulation signal are adjusted. This step may be performed by the control unit 120 as described above. Thereafter, execution continues with step S1020.

As shown in connection with FIG. 7B, steps S1010-S1050 may be performed following the timing sequence shown in FIG. 7B.

Fig. 11 is an exemplary flowchart of an electrical stimulation regulation method for abnormal muscle tension of a spastic cerebral palsy patient according to a third embodiment of the present invention. In combination with the electrical stimulation regulation and control device described in fig. 5, the electrical stimulation regulation and control method of this embodiment includes the following steps:

step S1110: and a second stimulating electrode is implanted in a sensory nerve root of a posterior root of the spinal cord, and an electromyographic recording electrode is implanted in muscle. The second stimulation electrode here may be the second stimulation electrode 410 shown in fig. 5.

Step S1120: a second electrical stimulation signal is applied. The second electrical stimulation signal may have default stimulation parameters.

Step S1130: and judging whether the muscle tension of the patient is improved or not according to the EMG signal. An EMG signal is an electromyographic signal recorded by an electromyographic recording electrode. This step may be performed by the control unit 120. If yes, executing step S1150 and step S1020; if no, go to step S1140.

Step S1140: the stimulation parameters of the second electrical stimulation signal are adjusted. This step may be performed by the control unit 120 as described above.

Step S1150: the second electrical stimulation signal is delivered for a duration of time T4. As shown in connection with fig. 7C, after the delivery of the second electrical stimulation signal is stopped, it is continuously determined whether the EMG signal improves, and when the result is negative, the stimulation parameters of the second electrical stimulation signal are adjusted and the application of the second electrical stimulation signal is started again.

After the step S1130 determines that the configuration is YES, the steps S1160-S1170 are also executed. Steps S1160-S1170 correspond to steps S910-S960, respectively, in FIG. 9, and are not expanded. It is understood that step S1160 may be performed simultaneously with step S1110.

As shown in connection with FIG. 7C, the various steps in the embodiment shown in FIG. 11 may be performed following the timing sequence shown in FIG. 7C.

According to the electrical stimulation regulation and control method for muscle tension abnormality of patients with spastic cerebral palsy, electrical stimulation on the motor nerve roots of the anterior spinal cord roots and electrical stimulation on the sensory nerve roots of the posterior spinal cord roots are combined, active motor nerve signals of the motor nerve roots of the anterior spinal cord roots are amplified, simultaneously afferent signals of the sensory nerve roots of the posterior spinal cord roots are inhibited, and under the comprehensive effect of two signals, the control capability of the muscle motor function of the patients on the active signals of the brain is enhanced, the muscle tension of the patients is weakened, and the problem of muscle tension abnormality of the patients is improved in two ways.

Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing disclosure is by way of example only, and is not intended to limit the present application. Various modifications, improvements and adaptations to the present application may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present application and thus fall within the spirit and scope of the exemplary embodiments of the present application.

Also, this application uses specific language to describe embodiments of the application. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the present application is included in at least one embodiment of the present application. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, some features, structures, or characteristics of one or more embodiments of the present application may be combined as appropriate.

Aspects of the present application may be embodied entirely in hardware, entirely in software (including firmware, resident software, micro-code, etc.) or in a combination of hardware and software. The above hardware or software may be referred to as "data block," module, "" engine, "" unit, "" component, "or" system. The processor may be one or more Application Specific Integrated Circuits (ASICs), digital Signal Processors (DSPs), digital signal processing devices (DAPDs), programmable Logic Devices (PLDs), field Programmable Gate Arrays (FPGAs), processors, controllers, microcontrollers, microprocessors, or a combination thereof. Furthermore, aspects of the present application may be represented as a computer product, including computer readable program code, embodied in one or more computer readable media. For example, computer-readable media can include, but are not limited to, magnetic storage devices (e.g., hard disk, floppy disk, magnetic tape … …), optical disks (e.g., compact Disk (CD), digital Versatile Disk (DVD) … …), smart cards, and flash memory devices (e.g., card, stick, key drive … …).

The computer readable medium may comprise a propagated data signal with the computer program code embodied therein, for example, on a baseband or as part of a carrier wave. The propagated signal may take any of a variety of forms, including electromagnetic, optical, and the like, or any suitable combination. The computer readable medium can be any computer readable medium that can communicate, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device. Program code on a computer readable medium may be propagated over any suitable medium, including radio, electrical cable, fiber optic cable, radio frequency signals, or the like, or any combination of the preceding.

Similarly, it should be noted that in the preceding description of embodiments of the application, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to require more features than are expressly recited in the claims. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.

Numerals describing the number of components, attributes, etc. are used in some embodiments, it being understood that such numerals used in the description of the embodiments are modified in some instances by the use of the modifier "about", "approximately" or "substantially". Unless otherwise indicated, "about", "approximately" or "substantially" indicates that the number allows a variation of ± 20%. Accordingly, in some embodiments, the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameter should take into account the specified significant digits and employ a general digit preserving approach. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the range are approximations, in the specific examples, such numerical values are set forth as precisely as possible within the scope of the application.

Although the present application has been described with reference to the present specific embodiments, it will be recognized by those skilled in the art that the foregoing embodiments are merely illustrative of the present application and that various changes and substitutions of equivalents may be made without departing from the spirit of the application, and therefore, it is intended that all changes and modifications to the above-described embodiments that come within the spirit of the application fall within the scope of the claims of the application.

Claims

1. An electrical stimulation regulation and control device for muscle tension abnormality of a spastic cerebral palsy patient, comprising: an electrical stimulation unit and a control unit, wherein,

the electrical stimulation unit comprises at least one stimulation electrode, the stimulation electrode is arranged in or out of the fasciculus of at least one target nerve root and is used for applying an electrical stimulation signal to the at least one target nerve root;

the control unit is used for controlling the stimulation parameters of the electrical stimulation signals.

2. The electrical stimulation modulation device of claim 1 further comprising a recording unit, wherein,

the stimulation electrodes comprise first stimulation electrodes, the target nerve root comprises a spinal anterior motor root, the electrical stimulation signals comprise first electrical stimulation signals, the first stimulation electrodes are arranged in or out of the fascicles of at least one spinal anterior motor root, and the first stimulation electrodes are used for applying the first electrical stimulation signals to the at least one spinal anterior motor root;

the recording unit comprises at least one recording electrode, the recording electrode is arranged in or out of the fasciculus of the at least one spinal cord anterior root motor nerve root and is used for recording the electric signals generated by the at least one spinal cord anterior root motor nerve root;

the control unit is further used for controlling the recording time of the recording electrode and controlling the stimulation parameter of the first electric stimulation signal according to the electric signal.

3. The electrical stimulation modulation device of claim 2 wherein the control unit is further configured to extract an active motor signal from the electrical signal and control the stimulation parameter of the first electrical stimulation signal such that the active motor signal is amplified.

4. The electrical stimulation modulation device according to claim 3, wherein the control unit determines that the electrical signal is the active motor signal when a rate of change of the electrical signal exceeds a preset threshold.

5. The electrical stimulation modulation device of claim 3, wherein the control unit controls the first stimulation electrode to deliver the first electrical stimulation signal when the control unit determines that the electrical signal is the active motor signal.

6. The electrical stimulation modulation device of claim 1, wherein the stimulation electrode comprises a second stimulation electrode, the target nerve root comprises a posterior spinal root sensory nerve root, the electrical stimulation signal comprises a second electrical stimulation signal, the second stimulation electrode is disposed within or outside a bundle of at least one of the posterior spinal root sensory nerve roots, the second stimulation electrode is configured to apply the second electrical stimulation signal to the at least one posterior spinal root sensory nerve root to inhibit afferent sensory signals; the control unit is further configured to control a stimulation parameter of the second electrical stimulation signal.

7. The electrical stimulation modulation device of claim 2, wherein the stimulation electrode further comprises a second stimulation electrode, the target nerve root comprises a dorsal root sensory nerve root, the electrical stimulation signal comprises a second electrical stimulation signal, the second stimulation electrode is disposed within or outside a bundle of at least one of the dorsal root sensory nerve roots, the second stimulation electrode is for applying the second electrical stimulation signal to the at least one dorsal root sensory nerve root to inhibit afferent sensory signals; the control unit is further configured to control a stimulation parameter of the second electrical stimulation signal.

8. The electrical stimulation regulation device of claim 6 or 7 further comprising at least one electromyography electrode disposed on a surface of a limb of a patient or in subcutaneous muscle tissue of the limb of the patient, the electromyography electrode for recording an electromyography signal; the control unit is also used for controlling the recording time of the electromyographic recording electrode and controlling the stimulation parameter of the second electrical stimulation signal according to the electromyographic signal.

9. The electrical stimulation modulation device of claim 8 wherein the electromyography recording electrode records the electromyography signal when the second stimulation electrode ceases to apply the second electrical stimulation signal.

10. The electrical stimulation modulation device of claim 2, wherein the anterior spinal motor roots are located on one or both sides of any one or more of the spinal segment from the cervical spinal segment C to the sacral spinal segment S.

11. The electrical stimulation modulation device of claim 6 or claim 7 wherein the dorsal root sensory nerve roots are located on either or both sides of any one or more of the spinal segments from the C-segment of the cervical medulla to the S-segment of the sacral medulla.

12. The electrical stimulation modulation device of claim 7, wherein the electrical stimulation unit further comprises at least one retrieval electrode implanted subcutaneously in the back of the patient, the retrieval electrode configured to mate with the first stimulation electrode and/or the second stimulation electrode in a monopolar stimulation mode.

13. The electrical stimulation modulation device of claim 7, wherein the first stimulation electrode and/or the second stimulation electrode comprises a carbon nanotube fiber electrode having a diameter in a range of 100nm to 100 μ ι η.

14. The electrical stimulation modulation device of claim 2 wherein the first electrical stimulation signal is a negative-first then positive charge-balanced biphasic pulse.

15. The electrical stimulation modulation device of claim 6 or 7 wherein the second electrical stimulation signal is a high frequency sinusoidal alternating current signal and/or a high frequency pulsed signal.

16. The electrical stimulation modulation device of claim 7, wherein the stimulation parameters include frequency, amplitude, and individual pulse width of the stimulation pulses.

17. The electrical stimulation modulation device of claim 16, wherein the stimulation pulses of the first electrical stimulation signal have a frequency in the range of 0.5Hz to 10kHz and a single pulse width in the range of 0.02 to 10ms.

18. The electrical stimulation modulation device of claim 16 wherein the frequency of the stimulation pulses of the second electrical stimulation signal is in the range of 0.01kHz to 100kHz and the individual pulse width is in the range of 0.02 to 10ms.

19. The electrical stimulation modulation device of claim 16 wherein the amplitude comprises a current amplitude in the range of 0.2 μ Α to 20mA.

20. An electrical stimulation regulation and control method for muscle tension abnormality of a spastic cerebral palsy patient comprises the following steps:

recording an electrical signal generated by at least one spinal cord anterior root motor nerve root;

applying a first electrical stimulation signal to the at least one spinal cord anterior root motor root; and

and controlling the stimulation parameters of the first electrical stimulation signal according to the electrical signal.

21. The electrical stimulation modulation method of claim 20 further comprising: applying a second electrical stimulation signal to at least one of the spinal cord posterior root sensory nerve roots to inhibit afferent sensory signals.