CN108261607A - A kind of functional transcutaneous electrical stimulation device for motion function regulation and control - Google Patents

Abstract

The invention relates to a functional transcutaneous electrical nerve stimulation device for motor function regulation, which includes a CPGs detection unit, a controller and a stimulation electrode; the CPGs detection unit is used to monitor the myoelectric signals generated by CPGs of the lower limbs of a human body, and monitors After receiving the myoelectric signal, send a signal generation instruction to the controller; the controller is used to receive the signal generation instruction, and generate a stimulation current according to preset parameters, and input it to the stimulation electrode; the stimulation electrode is placed on the skin of the subject's spine , used to output stimulating electric waves; the stimulating electric wave is a low-frequency main wave modulated by a high-frequency bidirectional asymmetric square wave; the CPGs detection unit is used to monitor the movement trend of the lower limbs of the human body to generate myoelectric signals, and to generate unique stimulating electric waves in time , to give synchronous stimulation to the user's spinal nerves, to give positive incentives to people's walking behavior; to promote the user's lower limb rehabilitation walking training.

Description

A functional transcutaneous electrical nerve stimulation device for motor function regulation

technical field

The invention belongs to the field of medical devices, in particular to a functional transcutaneous electrical nerve stimulation device for motor function regulation.

Background technique

Compared with electrical stimulation methods such as spinal cord electrical stimulation and epidural electrical stimulation, transcutaneous electrical stimulation has the advantages of non-implantation, safety, and convenience, and has been widely used in medical treatment. At present, the existing transcutaneous electrical nerve stimulation devices on the market at home and abroad often aim at symptoms such as insomnia, pain, and high blood pressure through electrical stimulation to sense the nerves to stimulate muscle contraction, reduce pain, and promote blood circulation. However, the regulation of motor function by stimulating spinal nerves through transcutaneous electrical stimulation, when and where to give precise and effective electrical stimulation has not been realized. On the other hand, the current existing transcutaneous electrical stimulation signals need to involve different electrical stimulation waveforms according to different needs and different stimulation locations; the currently commonly used electrical stimulation waveforms are bidirectional square wave pulses, and the adjustable parameters are: Current intensity, electric wave pulse width, electric wave frequency, etc. However, such electric stimulation methods and electric stimulation waveforms can only achieve the effect of inhibiting the stimulation of sensory nerves to achieve the effects of pain relief and labor pain. Neuromotor stimulation; and the systems of conventional therapy devices generally do not allow users to adjust predetermined configurations of electrical stimulation protocols.

Contents of the invention

In order to solve the above problems, the present invention provides a functional transcutaneous electrical nerve stimulation device for motor function regulation, the specific scheme is as follows:

A functional transcutaneous electrical nerve stimulation device for motor function regulation, including a CPGs detection unit, a controller and a stimulating electrode;

The CPGs detection unit is used to monitor the myoelectric signals generated by the CPGs of the lower limbs of the human body, and send signals to the controller to generate instructions after monitoring the myoelectric signals;

The controller is used to receive the signal generation instruction, generate the stimulation current according to the preset parameters, and input it to the stimulation electrode;

Stimulating electrodes are placed on the skin of the subject's spine to output stimulating electric waves;

The stimulating electric wave is a low-frequency main wave modulated by a high-frequency bidirectional asymmetric square wave as the carrier.

The CPGs detection unit is used to monitor the EMG signal of the lower limbs of the human body, and when the user has a willingness to walk, a unique stimulating electric wave is generated in time to give synchronous stimulation to the user's spinal nerves, giving positive incentives to people's walking behavior; it is more conducive to the user's Walking training.

Further, the parameters include amplitude, frequency, duty cycle, forward and reverse pulse width ratio and fundamental frequency.

Preferably, the amplitude range of the stimulating electric wave is 1-50mA, and the duty cycle is 10-50%; further preferably, the amplitude range is 30-45mA, and the duty cycle is 10-20%;

Using the stimulating electric waves with the above-mentioned duty cycle and amplitude can effectively stimulate the spinal cord nerves on the premise of ensuring the user's comfort and safety, so as to realize the walking action, and the control and recovery effect on the user's walking ability is good.

Preferably, the frequency range of the stimulating electric wave is: 1-50Hz; the frequency range of the fundamental wave is: 1-10kHz;

Preferably, the pulse width of the stimulating electric wave is inversely proportional to the amplitude, and the forward and reverse pulse width ratio is 1:2-1:9; more preferably 1:5-1:7; using the above-mentioned forward and reverse pulse width ratio , to further improve the effectiveness of spinal nerve stimulation, and at the same time, it can better balance the electrochemical balance in the human body and prevent the electrochemical reaction in the human body under long-term current stimulation.

Furthermore, the stimulating electrodes are placed on the skin at the L3-L5 of the subject's spine, and the treatment effect is optimal.

Furthermore, the controller includes a micro control unit, an inverter unit and a boost unit; the micro control unit includes a parameter setting module and an electrical signal generating module;

The parameter setting module is used to provide the user with an adjustment sub-module for adjusting parameters and receive the parameters set by the user;

The electrical signal generation module is used to receive signal generation instructions, generate analog electrical signals according to preset parameters, and output the analog electrical signals to the inverter unit;

The inverter unit is used to convert the positive voltage signal of the analog electrical signal into an alternating current signal;

The boost unit is used to amplify the amplitude of the alternating current signal to the amplitude satisfying the strength of the transcutaneous electric stimulation; and output the stimulating electric signal to the stimulating electrode.

Using highly integrated unit settings, the device is compact and flexible, with low power consumption, which is convenient for users to carry and perform rehabilitation training; the parameters of the electrical stimulation signal can be adjusted, which is convenient for users to carry out personalized rehabilitation training according to their own needs.

Furthermore, the controller also includes a current detection unit, and the micro control unit also includes a current comparison module and a current regulation module; used to ensure the validity of the output current;

The current detection unit is used to perform AD conversion on the analog electrical signal to obtain a digital signal, and send it to the current comparison module;

The current comparison module is used to compare the received digital signal with the preset output threshold, and when the comparison result is the same, output an analog electrical signal to the inverter unit; when the comparison result is different, send an adjustment instruction to the current adjustment module ;

The current regulation module is used to receive the regulation instruction, output the analog electric signal to the inverter unit after the parameter to the digital signal is the same as the preset output threshold.

The functional transcutaneous electrical nerve stimulation device for motor function regulation provided by the present invention studies the stimulating electric wave according to the scope of application, obtains a waveform with a high-frequency bidirectional asymmetric square wave as the basic wave, and uses CPGs detection to determine the stimulation. The generation timing of the electric wave ensures that the user can give the spinal cord synchronous electrical stimulation when the user has a subjective tendency to walk, so as to realize the effective walking movement of the lower limbs; The unit is highly integrated, with low power consumption. Compared with the traditional lower limb rehabilitation robot, it has a better effect on the gradual recovery of the user's walking ability, more flexible use, high user controllability, and good patient compliance.

Description of drawings

Fig. 1. The connection schematic diagram of each component of the functional transcutaneous electrical nerve stimulation device of embodiment 1;

Fig. 2. the waveform schematic diagram of the stimulation electric wave of embodiment 1;

Fig. 3. The connection schematic diagram of each component of the functional transcutaneous electrical nerve stimulation device of embodiment 2;

Fig. 4. Schematic diagram of the connection of each component of the functional transcutaneous electrical nerve stimulation device in Example 3;

Fig. 5. the schematic circuit diagram of embodiment 3 electric current detecting unit;

Fig. 6. The schematic circuit diagram of the step-up unit of embodiment 3;

Fig. 7. The schematic circuit diagram of embodiment 3 inverter unit;

Fig. 8. The schematic circuit diagram of the load protection unit of embodiment 3;

Figure 9. The sEMG image produced by the lower limbs of volunteers under the stimulation of general electrical stimulation equipment on the market;

Fig. 10. The sEMG figure produced by the lower limbs of volunteers under the stimulation of the percutaneous spinal cord electrical stimulation device of the present invention;

Figure 11. The sEMG images of volunteers' lower limbs produced under normal walking motion;

Figure 12. Schematic diagram of the correlation between sEMG images and scores.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings and examples. The following examples are only used to explain the content of the present invention and are not intended to limit the protection scope of the present invention.

Examples 1-6

A functional transcutaneous electrical nerve stimulation device for motor function regulation, as shown in Figure 1 and Figure 2, comprising a CPGs detection unit 101, a controller 102 and a stimulating electrode 103;

The CPGs detection unit 101 is used to monitor the myoelectric signals generated by the CPGs of the lower limbs of the human body, and send a signal generation instruction to the controller 102 after monitoring the myoelectric signals;

The controller 102 is configured to receive a signal generating instruction, generate a stimulating current according to preset parameters, and input it to the stimulating electrode 103;

Stimulating electrodes 103 are placed on the skin of the subject's spine for outputting stimulating electric waves;

The stimulating electric wave is a low-frequency main wave modulated by a high-frequency bidirectional asymmetric square wave as the carrier. The pulse width is inversely proportional to the amplitude. The parameters are set in Table 1.

Each parameter setting of table 1 embodiment 1-6

The functional transcutaneous electrical nerve stimulation device for motor function regulation provided in this embodiment, for the spinal cord motor nerve, reasonably set parameters to ensure that the output electrical stimulation signal can stimulate the user to take a normal step without causing serious discomfort to the patient It provides a small and convenient stimulation device with high practicability for patients' lower limb rehabilitation exercise.

Example 7

As shown in Figure 3, the difference between the functional transcutaneous electrical nerve stimulation device for motor function regulation and control provided in this embodiment is that it is further defined that the controller 102 includes a micro control unit 201, an inverter unit 202, a boost unit 203 and a current detection unit 206; the micro control unit 201 includes a parameter setting module 204, an electrical signal generation module 205, a current comparison module 207 and a current regulation module 208;

A parameter setting module 204, configured to provide the user with an adjustment sub-module for adjusting parameters, and receive parameters set by the user;

The electrical signal generating module 205 is configured to receive a signal generating instruction and generate an analog electrical signal according to preset parameters;

A current detection unit 206, configured to perform AD conversion on the analog electrical signal to obtain a digital signal, and send it to the current comparison module 207;

The current comparison module 207 is used to compare the received digital signal with the preset output threshold, and when the comparison result is the same, output the analog electrical signal to the inverter unit 202; send adjustment instructions;

The current regulation module 208 is used to receive the regulation instruction, and output the analog electric signal to the inverter unit 202 after the parameter to the digital signal is the same as the preset output threshold;

an inverter unit 202, configured to convert the positive voltage signal of the analog electrical signal into an alternating current signal;

The voltage boosting unit 203 is used to amplify the amplitude of the alternating current signal to an amplitude satisfying the strength of the transcutaneous electrical stimulation; and output the stimulating electrical signal to the stimulating electrode 103 .

The functional transcutaneous electrical nerve stimulation device for motor function regulation provided in this embodiment has highly integrated components, small size, and low power consumption. 12V DC can be used as a power supply, which is convenient for patients to carry with them for walking training; The parameters of the waveform are adjustable; the adjustment sub-module can be implemented in the form of software, or in the form of peripheral knobs or buttons, providing users with the function of adjusting parameters at any time to meet the different needs of different users for the intensity and mode of electrical stimulation , High practicality, good user experience.

Example 8

As shown in Figures 4-8, the functional transcutaneous electrical nerve stimulation device for motor function regulation provided by this embodiment is different from Embodiment 7 in that the controller 102 also includes a micro-control unit 201 and a voltage booster The optocoupler isolation unit 301 connected to the unit 203 is used to isolate the low voltage control terminal of the microcontroller unit 201 and the high voltage output terminal of the boost unit 203 to ensure the safe operation of the microprocessor control unit 201 . The controller 102 also includes a load protection unit 302 connected to the booster unit 203 and the stimulation electrode 103, used to stabilize the stimulation electrical signal output to the human body and prevent the human body from being harmed by load overcurrent caused by unstable factors or interference.

Comparative example 1-13

A functional transcutaneous electrical nerve stimulation device for motor function regulation. The difference from Embodiment 1 is that the parameter settings are shown in Table 2.

Table 2 Comparative example 1-13 each parameter setting

group Main wave frequency/Hz Fundamental frequency/kHz Amplitude/mA duty cycle Forward and reverse pulse width ratio Comparative example 1 60 5 25 20 1:5 Comparative example 2 65 5 25 20 1:5 Comparative example 3 30 12 25 20 1:5 Comparative example 4 30 15 25 20 1:5 Comparative example 5 45 7 55 10 1:7 Comparative example 6 45 7 60 10 1:7 Comparative example 7 45 7 37 6 1:7 Comparative example 8 45 7 37 55 1:7 Comparative example 9 45 7 37 65 1:7 Comparative example 10 45 7 37 80 1:7 Comparative Example 11 30 5 25 20 1:1 Comparative example 12 30 5 25 20 1:10 Comparative example 13 30 5 25 20 1:20

Test case

5 healthy volunteers were called, and the functional transcutaneous electrical nerve stimulation devices used in the regulation of motor function in Examples 1-6 and Comparative Examples 1-13 of the present invention and the general electrical stimulation equipment on the market were respectively used to perform transcutaneous electrical stimulation on the volunteers. Electrical stimulation of the spinal cord. The non-conscious walking behavior of the lower limbs of the volunteers was monitored, and the surface electromyographic signals (sEMG) of the lower limb muscle groups of the volunteers under the percutaneous spinal nerve electrical stimulation were measured. The measurement results are shown in Figures 9-12.

In the experiment, we recorded the sEMG images of volunteers' lower limbs in different states (general electric stimulation device on the market, percutaneous spinal nerve electric stimulation device of the present invention, conscious stepping movement). According to the characterization of the sEMG signals of the lower limb muscles, we scored the patterns of the sEMG signals of the lower limbs in different states. The test results are shown in Table 3; the scoring criteria are as follows:

5 points; it has a strong correlation with the sEMG pattern produced by people's conscious steps:

4 points; it has a strong correlation with the sEMG pattern produced by people's conscious steps

3 points: It has a certain correlation with the sEMG pattern produced by people's conscious steps

2 points: less relevant to the sEMG patterns produced by people's conscious steps

1 point; no correlation with the sEMG patterns produced by people's conscious steps.

Table 3 test results

From the above test results, it can be seen that the functional transcutaneous electrical nerve stimulation device for motor function regulation provided by the present invention adopts a unique adjustable waveform, which can realize the stimulation of complete walking behavior for patients. Among them, Example 4 and Example 5 group, the walking behavior is the most obvious and the sEMG correlation of lower limb muscles is better. However, there are certain differences between the transcutaneous spinal cord electrical stimulation device and volunteers' conscious stepping behavior in the lower limb movement state and sEMG signal representation, and there are significant differences between the embodiments.

Claims (10)

1. A functional transcutaneous electrical nerve stimulation device for motor function regulation, characterized in that it comprises a CPGs detection unit (101), a controller (102) and a stimulating electrode (103); The CPGs detection unit (101) is used to monitor the myoelectric signals generated by the CPGs of the lower limbs of the human body, and send a signal generation instruction to the controller (102) after monitoring the myoelectric signals; The controller (102) is configured to receive a signal generation instruction, generate a stimulating current according to preset parameters, and input it to the stimulating electrode (103); The stimulating electrodes (103) are placed on the skin of the subject's spine for outputting stimulating electric waves; The stimulating electric wave is a low-frequency main wave modulated with a high-frequency bidirectional asymmetric square wave as a carrier. 2. The functional transcutaneous electrical nerve stimulation device for motor function regulation as claimed in claim 1, wherein the preset parameters include amplitude, frequency, duty cycle, forward and reverse pulse width ratio and fundamental frequency. 3. The functional transcutaneous electrical nerve stimulation device for motor function regulation as claimed in claim 2, wherein the range of the amplitude of the stimulating electric wave is 1-50mA, and the duty cycle is 10-50% . 4. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 2, wherein the pulse width of the stimulating electric wave is inversely proportional to the amplitude, and the forward and reverse pulse width ratio is 1:2-1:9. 5. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 2, wherein the frequency range of the stimulating electric wave is: 1-50 Hz; the frequency range of the fundamental wave is: 1-50 Hz. 10kHz. 6. The functional transcutaneous electrical nerve stimulation device for motor function regulation according to any one of claims 1-5, characterized in that, the stimulating electrodes (103) are placed on the subject's vertebra L3- On the skin at L5. 7. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 1, characterized in that, the controller (102) comprises a micro control unit (201), an inverter unit (202) and A boost unit (203); the micro control unit (201) includes a parameter setting module (204) and an electrical signal generating module (205); The parameter setting module (204) is configured to provide the user with an adjustment sub-module for adjusting parameters, and receive preset parameters set by the user; The electrical signal generating module (205) is configured to receive a signal generating instruction, generate an analog electrical signal according to preset parameters, and output the analog electrical signal to the inverter unit (202); The inverter unit (202) is used to convert the positive voltage signal of the analog electrical signal into an alternating current signal; The voltage boosting unit (203) is used to amplify the amplitude of the alternating current signal to an amplitude satisfying the intensity of transcutaneous electrical stimulation; and output the stimulating electrical signal to the stimulating electrode (103). 8. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 7, characterized in that, the controller (102) also includes a current detection unit (206), and the micro-control unit ( 201) also includes a current comparison module (207) and a current regulation module (208); The current detection unit (206) is used to perform AD conversion on the analog electrical signal to obtain a digital signal, and send it to the current comparison module (207); The current comparison module (207) is used to compare the received digital signal with a preset output threshold, and when the comparison result is the same, output an analog electrical signal to the inverter unit (202); when the comparison result is different , sending an adjustment command to the current adjustment module (208); The current adjustment module (208) is configured to receive an adjustment instruction, adjust parameters until the digital signal is the same as a preset output threshold, and then output an analog electrical signal to the inverter unit (202). 9. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 7, characterized in that, the controller (102) also includes the micro-control unit (201) and boost unit (203) a connected optocoupler isolation unit (301), used for isolating the low voltage control terminal of the microcontroller unit (201) and the high voltage output terminal of the boost unit (203). 10. The functional transcutaneous electrical nerve stimulation device for motor function regulation and control as claimed in claim 7, characterized in that, the controller (102) also includes a booster unit (203) and a stimulating electrode (103) The connected load protection unit (302) is used for stabilizing the stimulation electric signal output to the human body.