CN108261607B - Functional percutaneous nerve electrical stimulation device for motor function regulation - Google Patents
Functional percutaneous nerve electrical stimulation device for motor function regulation Download PDFInfo
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- CN108261607B CN108261607B CN201810231965.XA CN201810231965A CN108261607B CN 108261607 B CN108261607 B CN 108261607B CN 201810231965 A CN201810231965 A CN 201810231965A CN 108261607 B CN108261607 B CN 108261607B
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- A—HUMAN NECESSITIES
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Abstract
The invention relates to a functional transcutaneous electrical nerve stimulation device for motor function regulation, which comprises a CPGs detection unit, a controller and a stimulation electrode; the CPGs detection unit is used for monitoring the electromyographic signals generated by the CPGs of the lower limbs of the human body and sending a signal generation instruction to the controller after the electromyographic signals are monitored; the controller is used for receiving a signal generation instruction, generating a stimulation current according to preset parameters and inputting the stimulation current to the stimulation electrode; the stimulating electrode is placed on the skin of the spine of the subject and used for outputting stimulating electric waves; the stimulation electric wave is a low-frequency main wave modulated by taking a high-frequency bidirectional asymmetric square wave as a carrier; the CPGs detection unit is adopted to monitor the electromyographic signals generated by the movement trend of the lower limbs of the human body, generate special stimulation electric waves in time, give synchronous stimulation to the spinal nerves of the user and stimulate the forward walking behavior of the user; the lower limb rehabilitation walking training of the user is promoted.
Description
Technical Field
The invention belongs to the field of medical appliances, and particularly relates to a functional transcutaneous electrical nerve stimulation device for motor function regulation.
Background
Compared with electrical stimulation methods such as spinal nerve electrical stimulation and epidural electrical stimulation, the percutaneous electrical stimulation has the advantages of non-implantation, safety, convenience and the like, and is widely used for treatment in the medical field. At present, the existing percutaneous nerve electrical stimulation devices in domestic and foreign markets usually achieve the effects of stimulating muscle contraction, reducing pain areas, promoting blood circulation and the like by electrically stimulating and sensing nerves aiming at symptoms such as insomnia, pain, hypertension and the like. However, regulation of motor function by stimulating spinal nerves via transcutaneous electrical stimulation, when and where precise and effective electrical stimulation is delivered, has not been achieved. On the other hand, the existing percutaneous electrical stimulation signals need to relate to different electrical stimulation waveforms according to different requirements and different stimulation positions; the current common electrical stimulation waveform is bidirectional square wave pulse, wherein adjustable parameters comprise current intensity, electric wave pulse width, electric wave frequency and the like, however, the electrical stimulation mode and the electrical stimulation waveform only can realize the function of inhibiting and sensing nerve excitation so as to achieve the effects of relieving pain, relieving pain and the like, and the parameters of the stimulation electrical signal waveform can not realize the motor stimulation of spinal nerves; and the systems of conventional treatment apparatus generally do not allow the user to adjust the predetermined configuration of the electrical stimulation protocol.
Disclosure of Invention
In order to solve the problems, the invention provides a functional transcutaneous electrical nerve stimulation device for motor function regulation, which comprises the following specific schemes:
a functional transcutaneous electrical nerve stimulation device for motor function regulation comprises a CPGs detection unit, a controller and a stimulation electrode;
the CPGs detection unit is used for monitoring the electromyographic signals generated by the CPGs of the lower limbs of the human body and sending a signal generation instruction to the controller after the electromyographic signals are monitored;
the controller is used for receiving a signal generation instruction, generating a stimulation current according to preset parameters and inputting the stimulation current to the stimulation electrode;
the stimulating electrode is placed on the skin of the spine of the subject and used for outputting stimulating electric waves;
the stimulation electric wave is a low-frequency main wave modulated by taking a high-frequency bidirectional asymmetric square wave as a carrier wave.
The CPGs detection unit is adopted to monitor the electromyographic signals of the lower limbs of the human body, when a user generates walking desire, a special stimulation electric wave is generated in time, synchronous stimulation is given to spinal nerves of the user, and the stepping behavior of the user is positively stimulated; is more beneficial to the walking training of the user.
Further, the parameters include amplitude, frequency, duty cycle, forward-reverse pulse width ratio, and fundamental frequency.
Preferably, the amplitude of the stimulation electric wave ranges from 1 mA to 50mA, and the duty ratio ranges from 10% to 50%; further preferably, the amplitude range is 30-45mA, and the duty ratio is 10-20%;
by adopting the stimulation electric wave with the duty ratio and the amplitude, the spinal nerves can be effectively stimulated on the premise of ensuring the comfort and the safety of the user so as to realize the walking action, and the control and the recovery effect on the walking ability of the user are good.
Preferably, the frequency range of the stimulating electric wave is: 1-50 Hz; the fundamental frequency range is: 1-10 kHz;
preferably, the pulse width and the amplitude of the stimulation electric wave are in inverse proportion, and the forward-reverse pulse width ratio is 1:2-1: 9; further preferably 1:5 to 1: 7; by adopting the forward and reverse pulse width ratio, the effectiveness of spinal nerve stimulation is further improved, the electrochemical balance in a human body can be better balanced, and the generation of electrochemical reaction in the human body under the long-time current stimulation is prevented.
Furthermore, the stimulation electrodes are placed on the skin of the subject at the vertebral levels L3-L5, and the treatment effect is optimal.
Furthermore, the controller comprises a micro-control unit, an inversion unit and a boosting unit; the micro control unit comprises a parameter setting module and an electric signal generating module;
the parameter setting module is used for providing a regulation submodule for regulating parameters for a user and receiving the parameters set by the user;
the electric signal generating module is used for receiving the signal generating instruction, generating an analog electric signal according to preset parameters and outputting the analog electric signal to the inversion unit;
the inversion unit is used for converting a positive voltage signal of the analog electric signal into an alternating current electric signal;
the boosting unit is used for amplifying the amplitude of the alternating current signal to the amplitude meeting the intensity of the percutaneous electrical stimulation; and outputs a stimulation electrical signal to the stimulation electrode.
The device is small and flexible, has low power consumption, and is convenient for the user to carry and rehabilitate training; the parameters of the electrical stimulation signals are adjustable, and the user can conveniently carry out personalized rehabilitation training according to the self requirement.
Furthermore, the controller also comprises a current detection unit, and the micro control unit also comprises a current comparison module and a current regulation module; the device is used for ensuring the validity of the output current;
the current detection unit is used for performing AD conversion on the analog electric signal to obtain a digital signal and sending the digital signal to the current comparison module;
the current comparison module is used for comparing the received digital signal with a preset output threshold value and outputting an analog electric signal to the inversion unit when the comparison results are the same; when the comparison results are different, sending an adjusting instruction to the current adjusting module;
and the current adjusting module is used for receiving an adjusting instruction, outputting an analog electric signal to the inversion unit after the parameter is the same as the digital signal and the preset output threshold value.
The functional transcutaneous electrical nerve stimulation device for regulating and controlling the motor function provided by the invention researches the stimulation electric wave according to the application range to obtain the waveform taking the high-frequency bidirectional asymmetric square wave as the fundamental wave, and the CPGs is utilized to detect and determine the generation time of the stimulation electric wave, so that the user is ensured to give synchronous proper electrical stimulation to spinal nerves when having the subjective stepping tendency, and the effective stepping walking movement of lower limbs is realized; on the other hand, the functional transcutaneous electrical nerve stimulation device provided by the invention has the advantages of small volume, high integration of each unit, low power consumption, better gradual recovery effect on the walking ability of the user, more flexible use, high controllability of the user and good compliance of the patient compared with the traditional lower limb rehabilitation robot.
Drawings
FIG. 1 is a schematic diagram showing the connection of the components of the functional transcutaneous electrical nerve stimulation device in example 1;
FIG. 2 is a waveform diagram of a stimulus wave of example 1;
fig. 3 is a schematic connection diagram of components of the functional transcutaneous electrical nerve stimulation device in example 2;
fig. 4 is a schematic connection diagram of the components of the functional transcutaneous electrical nerve stimulation device in example 3;
FIG. 5 is a schematic circuit diagram of a current detection unit according to embodiment 3;
FIG. 6 is a schematic circuit diagram of a booster unit according to embodiment 3;
FIG. 7 is a schematic circuit diagram of an inverter unit according to embodiment 3;
FIG. 8 is a schematic circuit diagram of a load protection unit according to embodiment 3;
fig. 9 is a graph of sEMG produced by the lower limbs of volunteers under stimulation by a commercially available electrical stimulation apparatus;
fig. 10 is a graph of sEMG produced by the lower limbs of a volunteer under stimulation by the transcutaneous electrical spinal nerve stimulation device of the present invention;
FIG. 11 is a graph of sEMG produced by the lower limbs of a volunteer during a normal striding motion;
fig. 12 is a schematic diagram showing correlation between sEMG and score.
Detailed Description
The invention is further described with reference to the following figures and examples, which are provided for the purpose of illustrating the general inventive concept and are not intended to limit the scope of the invention.
Examples 1 to 6
A functional transcutaneous electrical nerve stimulation device for motor function regulation, as shown in fig. 1 and 2, comprises a CPGs detection unit 101, a controller 102 and a stimulation electrode 103;
the CPGs detection unit 101 is used for monitoring an electromyographic signal generated by CPGs of the lower limb of the human body and sending a signal generation instruction to the controller 102 after monitoring the electromyographic signal;
the controller 102 is used for receiving a signal generation instruction, generating a stimulation current according to preset parameters, and inputting the stimulation current to the stimulation electrode 103;
the stimulation electrode 103 is placed on the skin of the subject at the spine for outputting a stimulation electric wave;
the stimulation electric wave is a low-frequency main wave modulated by taking a high-frequency bidirectional asymmetric square wave as a carrier wave, the pulse width is in inverse proportion to the amplitude, and all parameters are set as shown in table 1.
TABLE 1 settings for the parameters of examples 1-6
The functional percutaneous nerve electro-stimulation device for motor function regulation and control that this embodiment provided to spinal cord motor nerve, to the spinal cord motor nerve, the electrical stimulation signal of output can normally take a step for the user to the parameter assurance of reasonable setting, and does not bring serious uncomfortable influence for the patient, and the recovered exercise of low limbs for the patient provides the stimulation device that small and exquisite convenient practicality is high.
Example 7
As shown in fig. 3, the functional transcutaneous electrical nerve stimulation device for motor function regulation provided in this embodiment is different from embodiment 1 in that, further, the controller 102 includes a micro control unit 201, an inverter unit 202, a voltage boosting unit 203 and a current detection unit 206; the micro-control unit 201 comprises a parameter setting module 204, an electric signal generating module 205, a current comparing module 207 and a current adjusting module 208;
a parameter setting module 204, configured to provide a user with a regulation sub-module for regulating parameters, and receive parameters set by the user;
the electric signal generating module 205 is configured to receive a signal generating instruction and generate an analog electric signal according to a preset parameter;
the current detection unit 206 is configured to perform AD conversion on the analog electrical signal to obtain a digital signal, and send the digital signal to the current comparison module 207;
the current comparison module 207 is configured to compare the received digital signal with a preset output threshold, and output an analog electrical signal to the inverter unit 202 when the comparison results are the same; when the comparison results are different, sending an adjustment instruction to the current adjustment module 208;
the current adjusting module 208 is configured to receive an adjusting instruction, and output an analog electrical signal to the inverter unit 202 when the parameter is equal to the preset output threshold value when the digital signal is the same as the preset output threshold value;
an inverter unit 202 for converting a positive voltage signal of the analog electrical signal into an alternating current electrical signal;
the boosting unit 203 is used for amplifying the amplitude of the alternating current signal to an amplitude meeting the intensity of the transcutaneous electrical stimulation; and outputs a stimulation electrical signal to the stimulation electrode 103.
The functional transcutaneous electrical nerve stimulation device for motor function regulation and control provided by the embodiment has the advantages that all the components are highly integrated, the size is small, the power consumption is low, and 12V direct current can be used as a power supply, so that a patient can conveniently carry the device for walking training; the parameters of the waveform are adjustable; the adjusting sub-module can be realized in a software form, can also be realized in a form of a peripheral knob or a button, provides a function of adjusting parameters at any time for a user, and is suitable for different requirements of different users on the electrical stimulation intensity and the mode, high in practicability and good in user experience.
Example 8
As shown in fig. 4-8, the functional transcutaneous electrical nerve stimulation device for motor function regulation and control provided in this embodiment is different from embodiment 7 in that the controller 102 further includes an optical coupling isolation unit 301 connected to the micro control unit 201 and the voltage boost unit 203, and is configured to isolate the low voltage control terminal of the micro control unit 201 from the high voltage output terminal of the voltage boost unit 203, so as to ensure safe operation of the microprocessor control unit 201. The controller 102 further includes a load protection unit 302 connected to the voltage boost unit 203 and the stimulation electrode 103, for stabilizing the stimulation electrical signal output to the human body and preventing the human body from being injured by the load overcurrent phenomenon caused by unstable factors or interference.
Comparative examples 1 to 13
A functional transcutaneous electrical nerve stimulation device for motor function control, which is different from example 1 in that the parameter settings are shown in table 2.
TABLE 2 comparative examples 1-13 parameter settings
| Group of | Dominant wave frequency/Hz | Fundamental frequency/kHz | amplitude/mA | Duty cycle | Pulse width ratio of forward and backward |
| 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 examples
5 healthy volunteers were recruited and applied to the functional transcutaneous electrical nerve stimulation device for motor function control according to examples 1 to 6 and comparative examples 1 to 13 of the present invention and a general electrical stimulation device on the market, respectively, to perform transcutaneous electrical nerve stimulation to the spinal cord of the volunteers. The involuntary striding behavior of the lower limbs of the volunteers was monitored, and the surface electromyographic signals (sEMG) of the muscle groups of the lower limbs of the volunteers under transcutaneous electrical stimulation of the spinal nerves were measured, the results of which are shown in fig. 9-12.
In the experiments we recorded sEMG plots of the lower limbs of volunteers under different conditions (general electrical stimulation device on the market, transcutaneous electrical spinal nerve stimulation device of the invention, conscious striding movement). According to the characterization of the sEMG signals of the muscles of the lower limbs, the modes of the sEMG signals of the lower limbs under different states are graded, and the test results are shown in a table 3; the scoring criteria were as follows:
5 min; there is a strong correlation with sEMG patterns generated by human conscious strides:
4, dividing; has stronger correlation with sEMG pattern generated by human conscious step
And 3, dividing: has certain correlation with sEMG mode generated by human conscious step
And 2, dividing: with less correlation to sEMG patterns generated by conscious strides
1 minute; there is no correlation with sEMG patterns generated by human conscious strides.
TABLE 3 test results
From the above test results, it can be seen that the functional transcutaneous electrical nerve stimulation device for motor function control provided by the present invention can provide complete striding behavior stimulation to a patient by using a unique controllable waveform, wherein the striding behavior is most obvious and the sEMG correlation of the lower limb muscles is better in the group of the embodiment 4 and the embodiment 5. However, the transcutaneous spinal nerve electrical stimulation device has certain differences from the lower limb movement state and sEMG signal characterization of the conscious swing behavior of the volunteers, and the embodiments have significant differences.
Claims (5)
1. A functional transcutaneous electrical nerve stimulation device for motor function regulation is characterized by comprising a CPGs detection unit (101), a controller (102) and a stimulation electrode (103);
the CPGs detection unit (101) is used for monitoring electromyographic signals of walking intentions generated by the CPGs of the lower limbs of the human body and sending a signal generation instruction to the controller (102) after the electromyographic signals are monitored;
the controller (102) is used for receiving a signal generation instruction, generating a stimulation current according to preset parameters and inputting the stimulation current to the stimulation electrode (103);
the stimulation electrode (103) is placed on the skin of the spine of the subject and used for outputting stimulation electric waves;
the stimulation electric wave is a low-frequency main wave modulated by taking a high-frequency bidirectional asymmetric square wave as a carrier wave;
the preset parameters comprise amplitude, frequency, duty ratio, forward and reverse pulse width ratio and fundamental wave frequency;
wherein, the dominant wave frequency is 30-45HZ, the fundamental wave frequency is 5-7kHZ, the amplitude is 25-37mA, the duty ratio is 10-20, and the forward and reverse pulse width ratio is 1:5-1: 7;
the stimulation electrodes (103) are placed on the skin of the subject at vertebrae L3-L5.
2. The functional transcutaneous electrical nerve stimulation device for motor function regulation according to claim 1, wherein the controller (102) comprises a micro control unit (201), an inverter unit (202), and a voltage boosting unit (203); the micro control unit (201) comprises a parameter setting module (204) and an electric signal generating module (205);
the parameter setting module (204) is used for providing a regulation submodule for regulating parameters for a user and receiving preset parameters set by the user;
the electric signal generating module (205) is used for receiving a signal generating instruction, generating an analog electric signal according to preset parameters, and outputting the analog electric signal to the inverter unit (202);
the inversion unit (202) is used for converting a positive voltage signal of the analog electric signal into an alternating current electric signal;
the boosting unit (203) is used for amplifying the amplitude of the alternating current signal to the amplitude meeting the strength of the transcutaneous electrical stimulation; and outputs a stimulation electrical signal to the stimulation electrode (103).
3. The functional transcutaneous electrical nerve stimulation device for motor function regulation according to claim 2, wherein the controller (102) further comprises a current detection unit (206), and the micro control unit (201) further comprises a current comparison module (207) and a current regulation module (208);
the current detection unit (206) is used for performing AD conversion on the analog electric signal to obtain a digital signal and sending the digital signal to the current comparison module (207);
the current comparison module (207) is used for comparing the received digital signal with a preset output threshold value, and outputting an analog electric signal to the inversion unit (202) when the comparison results are the same; when the comparison results are different, sending an adjusting instruction to a current adjusting module (208);
and the current adjusting module (208) is used for receiving an adjusting instruction, adjusting parameters until the digital signals are the same as a preset output threshold value, and outputting analog electric signals to the inverter unit (202).
4. The functional transcutaneous electrical nerve stimulation device for motor function regulation according to claim 2, wherein the controller (102) further comprises an optical coupling isolation unit (301) connected with the micro control unit (201) and the voltage boosting unit (203) for isolating the low voltage control terminal of the micro control unit (201) and the high voltage output terminal of the voltage boosting unit (203).
5. The functional transcutaneous electrical nerve stimulation device for motor function control as claimed in claim 2, wherein the controller (102) further comprises a load protection unit (302) connected to the boosting unit (203) and the stimulation electrode (103) for stabilizing the stimulation electrical signal output to the human body.
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| CN109010008B (en) * | 2018-08-22 | 2024-09-17 | 深圳瑞格美科技有限公司 | Neuromuscular electrical stimulation method, neuromuscular electrical stimulator and host thereof |
| CN110404164B (en) * | 2019-08-29 | 2020-12-22 | 苏州大学 | Spinal cord closed loop electrical stimulation system |
| CN111195392A (en) * | 2019-12-31 | 2020-05-26 | 清华大学 | Implantable spinal cord stimulation system for spinal cord injury rehabilitation therapy |
| CN113058157B (en) * | 2021-02-25 | 2022-01-18 | 国家康复辅具研究中心 | Feedback type functional electrical stimulation system with multi-signal fusion |
| CN115337549A (en) * | 2022-01-27 | 2022-11-15 | 上海交通大学 | Electrical stimulation regulation and control device and method for muscle tension abnormality of spastic cerebral palsy patient |
| CN116943032B (en) * | 2023-09-20 | 2024-01-09 | 江西省精一医疗科技有限公司 | Electrical stimulation generating device, method, electronic device, and storage medium |
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