CN114082102A - Closed-loop vagus nerve stimulator based on scalp electroencephalogram - Google Patents
Closed-loop vagus nerve stimulator based on scalp electroencephalogram Download PDFInfo
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- CN114082102A CN114082102A CN202111339978.7A CN202111339978A CN114082102A CN 114082102 A CN114082102 A CN 114082102A CN 202111339978 A CN202111339978 A CN 202111339978A CN 114082102 A CN114082102 A CN 114082102A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36064—Epilepsy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/256—Wearable electrodes, e.g. having straps or bands
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- A—HUMAN NECESSITIES
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- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
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- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
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Abstract
The invention discloses a closed-loop vagus nerve stimulator based on scalp electroencephalogram, which comprises a signal acquisition module, a scalp electroencephalogram signal processing module and a vagus nerve stimulator. The signal acquisition module is connected with the scalp electroencephalogram signal processing module; the signal acquisition module is used for acquiring scalp electroencephalogram signals; the scalp electroencephalogram signal processing module is used for processing a scalp electroencephalogram signal, judging whether epilepsy occurs according to the processed scalp electroencephalogram signal and transmitting an epilepsy occurrence signal to the vagus nerve stimulator; the vagus nerve stimulator is configured to receive the signal and generate a stimulation pulse. When the scalp and brain electrical signals are collected and epilepsy is judged to occur, the vagus nerve stimulator automatically generates stimulation pulses in time to stimulate, and closed-loop stimulation is formed. Compared with an open-loop vagus nerve stimulator, the stimulation parameters are adjusted in time, and the stimulation effect is ideal; by collecting the scalp brain electrical signals, no craniotomy is needed, the operative wound is small, the accuracy rate of epilepsy judgment is high, and the false detection rate is low.
Description
Technical Field
The invention relates to a vagus nerve stimulator, in particular to a closed-loop vagus nerve stimulator based on scalp electroencephalogram.
Background
Epilepsy is a common brain disease, and most of the symptoms of epilepsy can be alleviated by drug treatment, while another part of epilepsy with drug resistance is called refractory epilepsy. The vagus nerve stimulator is a medical means for treating intractable epilepsy. However, most of the existing vagus nerve stimulators are open-loop systems, do not have the function of detecting epileptic seizure in real time, and cannot realize closed-loop stimulation.
At present, some closed-loop vagus nerve stimulators with functions of detecting epileptic seizures in real time and performing stimulation exist in the prior art, including closed-loop vagus nerve stimulators adopting intracranial electroencephalogram signal feedback and closed-loop vagus nerve stimulators adopting electrocardiosignal feedback.
However, the above-mentioned open-loop and closed-loop vagus nerve stimulators have several problems:
1) the stimulation parameters of the traditional open-loop vagus nerve stimulator are not adjusted timely, the stimulation effect is not ideal, and after the energy of the internal battery of the vagus nerve stimulator is exhausted, the battery needs to be replaced through a secondary operation.
2) The closed-loop vagus nerve stimulator adopting intracranial electroencephalogram signal feedback needs to extract the nerve action potential of a diseased part of a brain, and the operation trauma caused by placing a collecting electrode during craniotomy is large.
3) The closed-loop vagus nerve stimulator adopting electrocardiosignal feedback has low epilepsy early warning accuracy and high false detection rate.
Disclosure of Invention
The purpose of the invention is as follows: aiming at the defects, the invention provides the closed-loop vagus nerve stimulator based on the scalp electroencephalogram, which can stimulate timely, accurately and with high accuracy.
The technical scheme is as follows: in order to solve the problems, the invention adopts a closed-loop vagus nerve stimulator based on scalp electroencephalogram, which comprises a signal acquisition module, a scalp electroencephalogram signal processing module and a vagus nerve stimulator; the signal acquisition module is connected with the scalp electroencephalogram signal processing module; the signal acquisition module is used for acquiring scalp electroencephalogram signals; the scalp electroencephalogram signal processing module is used for processing a scalp electroencephalogram signal, judging whether epilepsy occurs according to the processed scalp electroencephalogram signal and transmitting an epilepsy occurrence signal to the vagus nerve stimulator; the vagus nerve stimulator is configured to receive a signal and generate a stimulation pulse.
Furthermore, the scalp electroencephalogram signal processing module comprises a multi-channel preamplifier connected with the signal acquisition module, a seizure detector connected with the multi-channel preamplifier and a first data transmission unit connected with the seizure detector; the epileptic seizure detector is used for processing the scalp brain electrical signals and judging whether epilepsia occurs or not; the first data transmission unit is used for transmitting epileptogenesis signals.
Further, the vagus nerve stimulator comprises a second data transmission unit, a second microprocessor connected with the second data transmission unit, and a pulse generator connected with the second microprocessor; the second data transmission unit is used for transmitting wireless signals with the first data transmission unit and receiving epileptogenesis signals; the second microprocessor is used for receiving the epileptogenesis signal and then sending a working instruction to the pulse generator, and the pulse generator is used for generating a stimulation pulse.
Further, the vagus nerve stimulator further comprises a wireless energy receiver for receiving the wirelessly transmitted electric energy and supplying power to the electrical structure in the vagus nerve stimulator.
Further, the vagus nerve stimulator further comprises an electrode-tissue impedance extractor, the pulse generator is provided with a stimulation electrode for transmitting a stimulation pulse to the vagus nerve, and the electrode-tissue impedance extractor is for measuring impedance between the stimulation electrode and the vagus nerve.
Further, the vagus nerve stimulator further comprises a temperature sensor for detecting tissue temperature.
The controller is used for displaying the working states of the scalp electroencephalogram signal processing module and the vagus nerve stimulator and adjusting parameters of stimulation pulses output by the vagus nerve stimulator.
Further, the signal acquisition module comprises a dry electrode.
Further, the dry electrode is arranged on the wearable helmet.
Has the advantages that: compared with the prior art, the invention has the following remarkable advantages: when the scalp and brain electrical signals are collected and epilepsy is judged to occur, the vagus nerve stimulator automatically generates stimulation pulses in time to stimulate, and closed-loop stimulation is formed. Compared with an open-loop vagus nerve stimulator, the stimulation parameters are adjusted in time, and the stimulation effect is ideal; by collecting the scalp brain electrical signals, no craniotomy is needed, the operative wound is small, the accuracy rate of epilepsy judgment is high, and the false detection rate is low. The electrical energy is received by the wireless energy receiver in the vagus nerve stimulator to supply power to the electric equipment, and the internal battery of the vagus nerve stimulator does not need to be replaced through a secondary operation.
Drawings
FIG. 1 is a block diagram illustrating the structure of a closed-loop vagal nerve stimulator in accordance with the present invention;
FIG. 2 is a schematic diagram of the closed-loop vagal nerve stimulator of the present invention in use;
FIG. 3 is a schematic view of a wearable helmet with a dry electrode and a scalp electroencephalogram signal processing module according to the present invention;
fig. 4 is a schematic diagram of a controller APP interface.
Detailed Description
As shown in fig. 1 and fig. 2, in this embodiment, a closed-loop vagus nerve stimulator based on scalp electroencephalogram includes a signal acquisition module, a scalp electroencephalogram signal processing module, and a vagus nerve stimulator, the signal acquisition module includes a plurality of dry electrodes 10, the dry electrodes 10 are used as acquisition electrodes for acquiring scalp electroencephalogram signals, as shown in fig. 3, the dry electrodes 10 are disposed on a wearable helmet 20, the wearable helmet 20 is provided with corresponding openings so that the dry electrodes 10 pass through, the wearable helmet 20 is used as a support structure for assisting, and the dry electrodes 10 are convenient to acquire scalp electroencephalogram signals. The dry electrode 10 is connected with a scalp electroencephalogram signal processing module 30.
The scalp brain electrical signal processing module 30 comprises a multi-channel preamplifier 301, a first microprocessor 302, a first data transmission unit 303 and a charging unit 304. The multi-channel preamplifier 301 is connected with the dry electrode 10 and amplifies the collected scalp electroencephalogram signals; the first microprocessor 302 comprises an analog-to-digital converter and a seizure detector, the output end of the multi-channel preamplifier 301 is connected with the input end of the analog-to-digital converter, the output end of the analog-to-digital converter is connected with the input end of the seizure detector, the output end of the seizure detector is connected with the input end of the first data transmission unit 303, the input end of the charging unit 304 is connected with an external energy supply device, the output end of the charging unit is connected with the multi-channel preamplifier 301, the first microprocessor 302 and the first data transmission unit 303, and the charging unit 304 supplies power to the electricity utilization module in the scalp electroencephalogram signal processing module 30. In the present embodiment, the charging unit 304 is a wired charging unit.
During epileptic seizure, the patient's scalp electroencephalogram signals have certain special forms, including action potentials (spike, poly-spike, complex) and local field potentials. The spike in the action potential has a steep waveform, while the local field potential is reflected by the excitation characteristic and postsynaptic potential inhibition of local neurons, contains a very large amount of information, and can reflect the change characteristic of the chronic potential of a target region. Because the action potential and the local field potential signals are very weak, a multichannel preamplifier 301 is required to amplify the collected scalp electroencephalogram signals, and the amplified signals enter a multichannel analog-to-digital converter built in a first microprocessor 302. The scalp electroencephalogram signals digitized by the multi-channel analog-to-digital converter are sent to the epileptic seizure detector to judge whether epileptic seizure occurs, the first microprocessor 302 transmits seizure information to the first data transmission unit 303 through the asynchronous communication serial port, and the first data transmission unit 303 transmits the information to the vagus nerve stimulator 40 by adopting Bluetooth communication.
The epileptic seizure detector can establish a coastline parameter detection model according to scalp electroencephalogram data acquired in a period of time. The coastline parameter is the cumulative length of the field potential signal curve within a given time window. When the nerve signal potential changes, the value of the nerve signal potential can be obviously increased, so that the physical significance is clear. In order to improve the accuracy of the detection model and reduce the false detection of epilepsy, before calculating the coastline parameter value, whether the amplitude and the slope of the electroencephalogram signal exceed the threshold value needs to be judged. The detection model will only determine that epilepsy has occurred if the amplitude, slope, and coastline parameters of the brain electrical signal exceed the thresholds. The other method for scalp electroencephalogram signal processing and epilepsy judgment is that the epileptic seizure detector can establish an epileptic signal detection model based on wavelet transformation according to scalp electroencephalogram data obtained in a period of time. The algorithm adopts an improved wavelet threshold function to remove artifact signals in the epileptic signals, and combines wavelet transformation resolution analysis and a nonlinear dynamics correlation algorithm to extract epileptic electroencephalogram signal features; and detecting and classifying the epileptic signals by using a nonlinear classifier in a support vector machine. It should be noted that the epilepsy detection algorithm based on the scalp electroencephalogram signal is not limited to the above two specific algorithms, and a detection algorithm more complicated or simpler than the above manner may be used in practical applications.
The vagus nerve stimulator 40 is disposed in a biocompatible ceramic housing, and the vagus nerve stimulator 40 includes a second data transmission unit 402, a second microprocessor 403, a pulse generator 404, a wireless energy receiver 401, an electrode-tissue impedance extractor 405, and a temperature sensor 406. The input end of the second data transmission unit 402 receives the wireless signal sent by the first data transmission unit 303, and the output end of the second data transmission unit 402 is connected with the input end of the second microprocessor 403, in this embodiment, the second microprocessor 403 is an ultra-low power consumption microprocessor. The output end of the second microprocessor 403 is connected with the input end of the pulse generator 404, the output end of the pulse generator 404 is connected with the input end of the electrode-tissue impedance extractor 405, the output end of the electrode-tissue impedance extractor 405 is connected with the input end of the second microprocessor 403, the output end of the temperature sensor 406 is connected with the input end of the ultra-low power consumption microprocessor 405, the wireless energy receiver 401 is connected with the second data transmission unit 402, the second microprocessor 403, the pulse generator 404, the electrode-tissue impedance extractor 405 and the temperature sensor 406 to supply power to the power utilization module in the vagus nerve stimulator 40, and in this embodiment, the pulse generator 404 is a switched resistor array pulse generator.
The wireless energy receiver 401 performs wireless power transmission with the wireless energy transmitter 50. In this embodiment, the wireless energy receiver 401 employs a distance-frequency adaptive magnetic resonance energy receiver, the wireless energy transmitter 50 employs a distance-frequency adaptive magnetic resonance energy transmitter, the wireless energy receiver 401 receives wireless electric energy transmitted by the wireless energy transmitter 50 to supply power to the power utilization module in the vagus nerve stimulator 40, thereby avoiding the disadvantage that the battery needs to be replaced by a secondary operation after the energy of the battery in the vagus nerve stimulator is exhausted, and the specific implementation technology of wireless electric energy transmission employs the technical scheme in the prior art, such as patent CN201811501220.7, and is not described herein again.
The second data transmission unit 402 receives the epileptic seizure information sent from the first data transmission unit 303 through bluetooth communication, and the second data transmission unit 402 receives control information from the controller 60 through bluetooth communication, the control information includes appropriate stimulation pulse parameter information and control instructions, the information is transmitted to the second microprocessor 403 through the asynchronous communication serial port, and the second microprocessor 403 sends a working command to the switched resistor array pulse generator 404 after receiving the information. Switched resistor array pulse generator 404 generates stimulation pulses to suppress epileptic seizures. The pulse generator 404 includes a stimulation electrode 4041 and an extension lead 4042, the stimulation electrode 4041 is clamped to the vagus nerve 70 on the left cervical region, and the extension lead 4042 delivers pulses to the stimulation electrode 4041 and the vagus nerve 70. The technical scheme of the prior art such as patent CN201610607640.8 is adopted in the suppression principle circuit arrangement of the switched resistor array pulse generator, and for the specific arrangement of the parameter information of the stimulation pulse, reference can be made to the prior literature: the present state and development trend [ J ] of hollow relevant instrument ,2009,33, section 2.3 of the present application relates to introduction of technical indicators of vagus nerve stimulators, and will not be described herein again.
The electrode-tissue impedance extractor 405 bi-directionally communicates with the second microprocessor 403 via a port line to determine whether the stimulation electrodes are in good contact with the target tissue and whether the lead is damaged. The temperature sensor 406 bi-directionally communicates with the ultra-low power microprocessor 403 via a port line to send an alarm when the temperature sensor finds a tissue temperature rise of two or more degrees during the generation of stimulation pulses or wireless charging of the vagus nerve stimulator.
As shown in fig. 4, the controller 60 is a mobile phone or tablet App developed based on the Android system, and is wirelessly and closely connected with the first data transmission unit 303 and the second data transmission unit 402 through a bluetooth module of the App terminal. App of the controller 60 may display the connection state between App and the scalp electroencephalogram signal processing module 30 and the vagal nerve stimulator 40; the controller 60 may display the operating status of the vagal nerve stimulator 40, including battery remaining life, system standby, battery charging, temperature, bio-impedance, and stimulation pulse parameters; the controller 60 can display the operating state of the scalp brain electrical signal processing module 30 including information of the remaining battery life, system standby, seizure parameters and seizure status (normal, pre-seizure and seizure). In addition to this, the frequency, width and amplitude of the stimulation pulses may be manually adjusted by the controller 60.
The controller 60 may also provide a guardian alarm function. When an epileptic seizure is detected, the controller 60 sends a short message to the patient guardian's handset via the server. The information content includes seizure information and the current location of the patient.
The closed-loop vagus nerve stimulator in the embodiment adopts scalp electroencephalogram signal feedback, and compared with an open-loop vagus nerve stimulator, the closed-loop vagus nerve stimulator has the advantages that stimulation parameters are adjusted timely, the stimulation effect is ideal, and the internal battery of the vagus nerve stimulator does not need to be replaced through a secondary operation. Compared with a closed-loop vagus nerve stimulator adopting intracranial electroencephalogram signal feedback, the closed-loop vagus nerve stimulator has small surgical trauma. Compared with a closed-loop vagus nerve stimulator adopting electrocardiosignal feedback, the epilepsy early warning device has high accuracy and low false detection rate.
Claims (9)
1. A closed-loop vagus nerve stimulator based on scalp electroencephalogram is characterized by comprising a signal acquisition module, a scalp electroencephalogram signal processing module and a vagus nerve stimulator; the signal acquisition module is connected with the scalp electroencephalogram signal processing module; the signal acquisition module is used for acquiring scalp electroencephalogram signals; the scalp electroencephalogram signal processing module is used for processing a scalp electroencephalogram signal, judging whether epilepsy occurs according to the processed scalp electroencephalogram signal and transmitting an epilepsy occurrence signal to the vagus nerve stimulator; the vagus nerve stimulator is configured to receive a signal and generate a stimulation pulse.
2. The closed-loop vagus nerve stimulator according to claim 1, wherein said scalp electroencephalogram signal processing module comprises a multi-channel preamplifier (301) connected to the signal acquisition module, a seizure detector connected to the multi-channel preamplifier (301), a first data transmission unit (303) connected to the seizure detector; the epileptic seizure detector is used for processing the scalp brain electrical signals and judging whether epilepsia occurs or not; the first data transmission unit (303) is used for transmitting epileptogenesis signals.
3. Closed-loop vagal nerve stimulator according to claim 2, characterized in that the vagal nerve stimulator comprises a second data transmission unit (402), a second microprocessor (403) connected to the second data transmission unit (402), and a pulse generator (404) connected to the second microprocessor (403); the second data transmission unit (402) is used for carrying out wireless signal transmission with the first data transmission unit (303), and the second data transmission unit (402) is used for receiving the epileptogenesis signal; the second microprocessor (403) is used for receiving the epileptogenesis signal and then sending a working instruction to the pulse generator (404); the pulse generator (404) is for generating stimulation pulses.
4. The closed-loop vagal nerve stimulator of claim 3, further comprising a wireless energy receiver (401), the wireless energy receiver (401) for receiving wirelessly transmitted electrical energy and powering a powered device in the vagal nerve stimulator.
5. The closed-loop vagal nerve stimulator of claim 3, further comprising an electrode-tissue impedance extractor (405), the pulse generator (404) being provided with a stimulation electrode for delivering a stimulation pulse to the neural tissue, the electrode-tissue impedance extractor (405) being configured to measure the impedance between the stimulation electrode and the neural tissue.
6. The closed-loop vagal nerve stimulator of claim 3, further comprising a temperature sensor (406), the temperature sensor (406) for detecting tissue temperature.
7. The closed-loop vagus nerve stimulator according to claim 3, further comprising a controller (60), wherein the controller (60) performs wireless signal transmission with the second data transmission unit (402), and the controller (60) is configured to display the operating status of the scalp electroencephalogram signal processing module and the vagus nerve stimulator, and to adjust the parameters of the stimulation pulses output by the vagus nerve stimulator.
8. The closed-loop vagal nerve stimulator of claim 1, characterized in that the signal acquisition module comprises a dry electrode (10).
9. The closed-loop vagal nerve stimulator of claim 8, characterized in that the dry electrode (10) is disposed on a wearable helmet (20).
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114642440A (en) * | 2022-05-23 | 2022-06-21 | 博睿康科技（常州）股份有限公司 | Method for acquiring preset duration of stimulation system, stimulation system and regulation and control method thereof |
| CN115177209A (en) * | 2022-06-24 | 2022-10-14 | 东北大学 | Wearable minimally invasive closed-loop regulation and control device for infant epilepsy |
| CN116251295A (en) * | 2023-03-09 | 2023-06-13 | 北京工业大学 | Focal epileptic electric guidance-nerve electric regulation and control system and method |
-
2021
- 2021-11-12 CN CN202111339978.7A patent/CN114082102A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114642440A (en) * | 2022-05-23 | 2022-06-21 | 博睿康科技（常州）股份有限公司 | Method for acquiring preset duration of stimulation system, stimulation system and regulation and control method thereof |
| CN115177209A (en) * | 2022-06-24 | 2022-10-14 | 东北大学 | Wearable minimally invasive closed-loop regulation and control device for infant epilepsy |
| CN116251295A (en) * | 2023-03-09 | 2023-06-13 | 北京工业大学 | Focal epileptic electric guidance-nerve electric regulation and control system and method |
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