Vagus nerve stimulation device compatible with magnetic resonance environment

Abstract

The invention discloses a vagus nerve stimulation device compatible with a magnetic resonance environment, which comprises a host, an electrode and a connecting wire, two ends of the connecting wire are electrically connected with the host and the electrode respectively, and the host comprises a shell and a circuit board arranged in the shell; the circuit board comprises a processing module, and a power supply module, a pulse waveform modulation module and an output module which are electrically connected with the processing module; the output module is electrically connected with the connecting wire; the processing module is used for controlling the power supply module to input current to the pulse waveform modulation module, controlling the pulse waveform modulation module to generate waveform pulse and transmit the waveform pulse to the output module, and controlling the output module to output stimulation current to the electrode through the connecting wire; the shell is a magnetic shielding shell, a through hole is formed in the shell, one end of the connecting wire penetrates through the through hole to be connected with the circuit board, a gasket is arranged between the connecting wire and the through hole, and the gasket is a magnetic shielding gasket, so that the vagus nerve stimulation equipment can be compatible with a magnetic resonance environment generated by magnetic resonance imaging equipment.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical equipment, and in particular relates to a vagus nerve stimulation device compatible with a magnetic resonance environment. Background Art

[0002] Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive medical device that regulates the central and autonomic nervous system physiological functions by electrically stimulating the vagus nerve to improve the symptoms of many clinical diseases such as epilepsy, depression, and chronic pain. Magnetic resonance imaging (MRI) is a non-invasive medical imaging device that uses strong magnetic fields and radio waves to generate detailed images of the internal structure of the human body. Medical images of the patient's body can be obtained through MRI, and then medical diagnosis of the patient can be performed based on the medical images.

[0003] Typically, a vagus nerve stimulation device includes a host, wires, and electrodes. The electrodes are attached to the vagus nerve of the patient's body, and the host is connected to the electrodes through the wires. In this way, the host can transmit a stimulation current to the electrodes through the wires, so that the stimulation current can electrically stimulate the patient's vagus nerve through the electrodes to achieve electrical stimulation treatment for the patient. However, when a vagus nerve stimulation device is used to perform electrical stimulation treatment on a patient while a magnetic resonance imaging device is used to obtain medical images of the patient's body, the magnetic field generated by the magnetic resonance imaging device will magnetize the circuit elements in the vagus nerve stimulation device, causing the vagus nerve stimulation device to be unable to work normally in a magnetic resonance environment, thereby causing the vagus nerve stimulation device to be incompatible with the magnetic resonance environment generated by the magnetic resonance imaging device. Summary of the invention

[0004] In order to solve the above problems existing in the prior art, the present invention provides a vagus nerve stimulation device compatible with a magnetic resonance environment. The technical problem to be solved by the present invention is achieved through the following technical solutions:

[0005] In the first aspect, the present invention provides a vagus nerve stimulation device compatible with a magnetic resonance environment, comprising a main unit, an electrode and a connecting wire, wherein the two ends of the connecting wire are electrically connected to the main unit and the electrode respectively, and the main unit comprises a shell and a circuit board arranged in the shell; the circuit board comprises a processing module and a power module electrically connected to the processing module, a pulse waveform modulation module and an output module, and the output module is electrically connected to the connecting wire; the processing module is used to control the power module to input current to the pulse waveform modulation module, control the pulse waveform modulation module to generate waveform pulses and transmit them to the output module, and control the output module to output stimulation current to the electrode through the connecting wire; the shell is a magnetic shielding shell, and a through hole is provided on the shell, one end of the connecting wire passes through the through hole and is connected to the circuit board, and a gasket is provided between the connecting wire and the through hole, and the gasket is a magnetic shielding gasket.

[0006] In one embodiment of the present invention, the output module includes a low-pass filter circuit and an anti-RF interference filter circuit.

[0007] In one embodiment of the present invention, the connecting wires are twisted pair wires.

[0008] In one embodiment of the present invention, the electrode includes a contact head for contacting a human body, and the material of the contact head is conductive silicone.

[0009] In one embodiment of the present invention, the circuit board also includes an interference monitoring module, which includes a noise collector, a comparator and a controller; the noise collector is used to collect the noise value of the environment, the comparator is used to compare the size between the noise value and a preset threshold, and the controller is used to control the host to start according to the comparison result of the comparator.

[0010] In one embodiment of the present invention, the circuit board also includes a waveform monitoring module, which includes a waveform detector and an alarm. The waveform detector is electrically connected to the output module, and the waveform detector and the alarm are both electrically connected to the processing module. The waveform detector is used to receive the stimulation current output by the output module and detect the waveform signal of the stimulation current. The processing module is used to control the alarm to turn on or off according to the difference between the waveform signal detected by the waveform detector and the preset waveform signal.

[0011] In one embodiment of the present invention, it also includes a control handle and a transmission line. The control handle is located outside the housing of the host, and is connected to the circuit board of the host through the transmission line. The control handle includes a switch and an intensity adjustment button; the switch is used to control the on and off of the current between the host and the electrode, and the intensity adjustment button is used to adjust the magnitude of the stimulation current output by the host to the electrode.

[0012] In one embodiment of the present invention, the circuit board further includes at least one of an overvoltage protection circuit, an overcurrent protection circuit and an overheat protection circuit.

[0013] In one embodiment of the present invention, the circuit board further includes a boost module, which is disposed between the pulse waveform modulation module and the output module and is used to perform voltage boost processing on the waveform pulse output by the pulse waveform modulation module.

[0014] In one embodiment of the present invention, the circuit board further comprises a storage module, which is electrically connected to the processing module; the storage module is used to store stimulation parameters of the stimulation current output by the output module to the electrode, the stimulation parameters comprising at least one of waveform parameters, current intensity, stimulation duration and number of stimulations;

[0015] The circuit board also includes a transmission module, which is used to connect to the host computer to transmit the storage data in the storage module to the host computer. The storage data includes stimulation parameters of the stimulation current output by the output module to the electrode.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] In the above scheme of the present application, first, a vagus nerve stimulation device compatible with a magnetic resonance environment includes a host, an electrode and a connecting wire, and the two ends of the connecting wire are electrically connected to the host and the electrode respectively. In this way, the host can transmit a stimulation current to the electrode through the connecting wire, so that the stimulation current can electrically stimulate the patient's vagus nerve through the electrode to achieve electrical stimulation treatment for the patient. The host includes a shell and a circuit board arranged in the shell, the shell is a magnetic shielding shell, a through hole is provided on the shell, one end of the connecting wire passes through the through hole and is connected to the circuit board, a gasket is provided between the connecting wire and the through hole, and the gasket is a magnetic shielding gasket. In this way, the magnetic shielding shell can shield the magnetic field in the environment where the shell is located, reduce the magnetization effect of the external magnetic field on the circuit elements in the circuit board in the shell, and avoid the failure of the circuit elements in the circuit board under the action of the external magnetic field, so that the vagus nerve stimulation device can be compatible with the magnetic resonance environment generated by the magnetic resonance imaging device. In addition, the magnetic shielding gasket is arranged in the gap between the connecting wire and the through hole, which can prevent the external magnetic field from passing through the gap between the connecting wire and the through hole and affecting the circuit elements in the circuit board, thereby further improving the shielding effect of the vagus nerve stimulation device on the external magnetic field, and further improving the adaptability of the vagus nerve stimulation device to the magnetic resonance environment generated by the magnetic resonance imaging equipment.

[0018] Secondly, the circuit board includes a processing module and a power module, a pulse waveform modulation module and an output module electrically connected to the processing module, and the output module is electrically connected to the connecting wire; the processing module is used to control the power module to input current to the pulse waveform modulation module, control the pulse waveform modulation module to generate waveform pulses and transmit them to the output module, and control the output module to output stimulation current to the electrode through the connecting wire. In this way, the processing module can transmit stimulation current to the connecting wire through the power module, the pulse waveform modulation module and the output module, and output stimulation current to the electrode through the connecting wire, so that the stimulation current can electrically stimulate the patient's vagus nerve through the electrode to achieve electrical stimulation treatment for the patient. In addition, the processing module can control the pulse waveform modulation module to generate different waveform pulses according to the conditions of different patients, so that the vagus nerve stimulation device can perform targeted treatment according to the specific conditions of different patients.

[0019] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of a vagus nerve stimulation device provided by an embodiment of the present invention;

[0021] Figure 2 is a circuit diagram of a host in an embodiment of the present invention;

[0022] Figure 3 Schematic diagram of a host and a control handle in an embodiment of the present invention.

[0023] Figure numerals: 1-main unit, 11-housing, 2-electrode, 21-contact head, 3-connecting wire, 4-control handle, 41-switch, 42-intensity adjustment button, 5-transmission line. DETAILED DESCRIPTION

[0024] The present invention is further described in detail below with reference to specific embodiments, but the embodiments of the present invention are not limited thereto.

[0025] See also Figure 1 and Figure 2The embodiment of the present invention provides a vagus nerve stimulation device compatible with a magnetic resonance environment, comprising a main unit 1, an electrode 2 and a connecting wire 3, wherein two ends of the connecting wire 3 are electrically connected to the main unit 1 and the electrode 2 respectively, and the main unit 1 comprises a shell 11 and a circuit board arranged in the shell 11; the circuit board comprises a processing module and a power module electrically connected to the processing module, a pulse waveform modulation module and an output module, and the output module is electrically connected to the connecting wire 3; the processing module is used to control the power module to input current to the pulse waveform modulation module, control the pulse waveform modulation module to generate waveform pulses and transmit them to the output module, and control the output module to output stimulation current to the electrode 2 through the connecting wire 3; the shell 11 is a magnetic shielding shell, and a through hole is provided on the shell 11, one end of the connecting wire 3 passes through the through hole and is connected to the circuit board, and a gasket is provided between the connecting wire 3 and the through hole, and the gasket is a magnetic shielding gasket.

[0026] In some embodiments of the present application, the housing 11 includes an upper housing and a lower housing, the upper housing and the lower housing are connected by a snap-fit ​​structure, the upper housing and the lower housing together form a receiving cavity, and the circuit board is arranged in the receiving cavity. In this way, the upper housing and the lower housing are detachably connected, which is convenient for installing and repairing the circuit board in the housing 11.

[0027] In some embodiments of the present application, the processing module is a microprocessor chip.

[0028] In some embodiments of the present application, the above-mentioned power module is used to power various circuits on the circuit board. A battery or a power connection line is also provided in the housing 11. The power module is electrically connected to the battery, or the power module is electrically connected to an external power supply through the power connection line.

[0029] In some embodiments of the present application, the pulse waveform modulation module includes a waveform control circuit, an amplifier circuit, and a filter circuit, etc. The power module inputs the pulse current into the waveform control circuit, and the waveform control circuit modulates the pulse signal according to the set stimulation parameters to generate a specific waveform that meets the treatment requirements; the set stimulation parameters include parameters such as pulse width, amplitude, frequency or phase. The amplifier circuit is used to enhance the amplitude of the pulse signal to ensure that the signal is strong enough to stimulate the vagus nerve; the amplifier circuit can be an operational amplifier, a transistor amplifier, or other types of amplifiers. The filter circuit is used to filter out noise and interference in the pulse signal to ensure the clarity and accuracy of the signal.

[0030] In some embodiments of the present application, the processing module may send set stimulation parameters to the pulse waveform modulation module, and the pulse waveform modulation module may generate specific waveform pulses according to the set stimulation parameters sent by the processing module.

[0031] In some embodiments of the present application, the output module may be an I / O circuit.

[0032] In some embodiments of the present application, the magnetic shielding shell is a shell 11 made of magnetic shielding material. Magnetic shielding material is a material that can block, absorb and disperse magnetic fields, including soft magnetic materials and hard magnetic materials. Soft magnetic material is a material with high magnetic permeability and low coercivity, which can absorb and disperse magnetic fields and guide them into the material. Common soft magnetic materials include ferrite, manganese oxide, iron-nickel alloy, etc. Ferrite is an amorphous material with high magnetic permeability, low coercivity and good corrosion resistance, suitable for shielding high-frequency magnetic fields. Manganese oxide is a ceramic material with high magnetic permeability and low coercivity, suitable for shielding low-frequency magnetic fields. Iron-nickel alloy is a metal material with high magnetic permeability and low coercivity, suitable for shielding medium-frequency magnetic fields. Hard magnetic material is a material with high coercivity and high saturation magnetic induction intensity, which can block the penetration of magnetic fields and reduce the interference of magnetic fields. Common hard magnetic materials include neodymium iron boron, neodymium hydride, etc. NdFeB is a rare earth permanent magnet material with high coercivity and high saturation magnetic flux density, suitable for shielding high-frequency magnetic fields. Neodymium hydride is a metal hydride with high coercivity and high saturation magnetic flux density, suitable for shielding low-frequency magnetic fields.

[0033] In some embodiments of the present application, the magnetic shielding gasket is a gasket made of magnetic shielding material. The gasket is an annular gasket, which is sleeved outside the connecting wire 3, and the inner circumference of the annular gasket abuts against the outer circumference of the connecting wire 3, and the outer circumference of the annular gasket abuts against the inner wall of the through hole.

[0034] In some embodiments of the present application, the electrode 2 may be an earphone-type electrode, and the vagus nerve stimulation device may perform electric shock stimulation on the vagus nerve of the ear.

[0035] In the above scheme of the present application, first, a vagus nerve stimulation device compatible with a magnetic resonance environment includes a host 1, an electrode 2 and a connecting wire 3, and the two ends of the connecting wire 3 are electrically connected to the host 1 and the electrode 2 respectively. In this way, the host 1 can transmit a stimulation current to the electrode 2 through the connecting wire 3, so that the stimulation current can electrically stimulate the patient's vagus nerve through the electrode 2 to achieve electrical stimulation treatment for the patient. The host 1 includes a shell 11 and a circuit board arranged in the shell 11, the shell 11 is a magnetic shielding shell, and a through hole is provided on the shell 11. One end of the connecting wire 3 passes through the through hole and is connected to the circuit board. A gasket is provided between the connecting wire 3 and the through hole, and the gasket is a magnetic shielding gasket. In this way, the magnetic shielding shell can shield the magnetic field in the environment where the shell 11 is located, reduce the magnetization effect of the external magnetic field on the circuit elements in the circuit board in the shell 11, and avoid the failure of the circuit elements in the circuit board under the action of the external magnetic field, so that the vagus nerve stimulation device can be compatible with the magnetic resonance environment generated by the magnetic resonance imaging device. In addition, the magnetic shielding gasket is arranged in the gap between the connecting wire 3 and the through hole, which can prevent the external magnetic field from passing through the gap between the connecting wire 3 and the through hole to affect the circuit elements in the circuit board, thereby further improving the shielding effect of the vagus nerve stimulation device on the external magnetic field, and further improving the adaptability of the vagus nerve stimulation device to the magnetic resonance environment generated by the magnetic resonance imaging equipment.

[0036] Secondly, the circuit board includes a processing module and a power module, a pulse waveform modulation module and an output module electrically connected to the processing module, and the output module is electrically connected to the connecting wire 3; the processing module is used to control the power module to input current to the pulse waveform modulation module, control the pulse waveform modulation module to generate waveform pulses and transmit them to the output module, and control the output module to output stimulation current to the electrode 2 through the connecting wire 3. In this way, the processing module can transmit stimulation current to the connecting wire 3 through the power module, the pulse waveform modulation module and the output module, and output stimulation current to the electrode 2 through the connecting wire 3, so that the stimulation current can electrically stimulate the patient's vagus nerve through the electrode 2 to achieve electrical stimulation treatment for the patient. In addition, the processing module can control the pulse waveform modulation module to generate different waveform pulses according to the conditions of different patients, so that the vagus nerve stimulation device can perform targeted treatment according to the specific conditions of different patients.

[0037] It can be understood that the waveform pulse can include a high-frequency pulse band and a low-frequency peak pulse band. The processing module can input different set stimulation parameters into the pulse waveform modulation module according to the conditions of different patients. The pulse waveform modulation module can generate high-frequency pulse bands and low-frequency peak pulse bands according to different set stimulation parameters, and generate different waveform pulses by controlling the duration of the high-frequency pulse band and the low-frequency peak pulse band, so that targeted treatment can be carried out according to the specific conditions of different patients.

[0038] It can be understood that the magnetic field generated by the magnetic resonance imaging device includes a strong magnetic field and a radio frequency magnetic field, both of which will affect the electronic components in the circuit board of the vagus nerve stimulation device. The magnetic shielding shell and magnetic shielding gasket in the present application can shield the strong magnetic field and radio frequency magnetic field generated by the magnetic resonance imaging device, reduce the magnetizing effect of the strong magnetic field and radio frequency magnetic field on the circuit elements in the circuit board inside the shell 11, and avoid the failure of the circuit elements in the circuit board under the action of the strong magnetic field and radio frequency magnetic field, so that the vagus nerve stimulation device can be compatible with the magnetic resonance environment generated by the magnetic resonance imaging device.

[0039] In some embodiments of the present application, the output module includes a low-pass filter circuit and an anti-RF interference filter circuit. In this way, the high-frequency signal can be filtered out by the low-pass filter circuit, making the signal smoother and purer, and improving the quality and accuracy of the signal; the RF interference signal can be filtered out by the anti-RF interference filter circuit, suppressing RF noise, and improving the quality and accuracy of the signal; thereby ensuring the stability of the waveform pulse output, avoiding the external magnetic field from affecting the waveform signal of the waveform pulse, and further improving the adaptability of the vagus nerve stimulation device to the magnetic resonance environment generated by the magnetic resonance imaging device.

[0040] In some embodiments of the present application, the low-pass filter circuit may be an RC low-pass filter, and the anti-radio frequency interference filter circuit may be an RFI filter.

[0041] In some embodiments of the present application, the connecting wire 3 is a twisted pair. A twisted pair is a wire structure consisting of two copper wires with an insulating protective layer. By twisting the two wires together at a certain density, signal interference can be effectively reduced, and the stability and quality of data transmission can be ensured. In this way, the signal interference of the external magnetic field on the vagus nerve stimulation device can be further reduced, and the external magnetic field can be prevented from affecting the signal of the stimulation current in the connecting wire 3, ensuring the stability of the output waveform pulse, and further improving the adaptability of the vagus nerve stimulation device to the magnetic resonance environment generated by the magnetic resonance imaging device.

[0042] In some embodiments of the present application, differential signal transmission technology can be used to transmit signals between modules in the circuit board. In this way, electromagnetic interference in the signal transmission process can be reduced, and the signal interference of the external magnetic field on the vagus nerve stimulation device can be further reduced.

[0043] In some embodiments of the present application, the electrode 2 includes a contact head 21 for contacting the human body, and the material of the contact head 21 is conductive silicone. In this way, the conductive silicone can achieve good contact and fit with the human body, thereby avoiding poor contact and affecting the treatment effect.

[0044] In some embodiments of the present application, the circuit board also includes a waveform monitoring module, the waveform monitoring module includes a waveform detector and an alarm, the waveform detector is electrically connected to the output module, the waveform detector and the alarm are both electrically connected to the processing module, the waveform detector is used to receive the stimulation current output by the output module and detect the waveform signal of the stimulation current, and the processing module is used to control the alarm to be turned on or off according to the difference between the waveform signal detected by the waveform detector and the preset waveform signal. In this way, the stimulation current output by the output module is received by the waveform detector and the waveform signal of the stimulation current is detected, and the alarm is controlled to be turned on or off according to the difference between the waveform signal detected by the waveform detector and the preset waveform signal by the processing module. By detecting the waveform of the output stimulation current, it can be determined whether the electronic components on the circuit board in the vagus nerve stimulation device are affected by the magnetic resonance environment of the magnetic resonance imaging device, so as to avoid the vagus nerve stimulation device being affected by the magnetic resonance environment and affecting its therapeutic effect.

[0045] In some embodiments of the present application, the circuit board also includes multiple filtering circuits, all of which are connected to the processing module. The processing module can also switch different filtering circuits for filtering or adjust output parameters according to the difference between the waveform signal detected by the waveform detector and the preset waveform signal, so as to strengthen the processing of magnetic field interference and improve the anti-interference ability of the vagus nerve stimulation device.

[0046] In some embodiments of the present application, the waveform detector may be a current detection chip, such as an FP135 current detection chip. The current detection chip can measure the current by sensing the voltage drop across a resistor, and can detect the waveform of the stimulus current regardless of whether the resistor is placed between the power supply and the load or between the load and the ground terminal.

[0047] In some embodiments of the present application, the waveform signal detected by the waveform detector includes at least one of the frequency, high frequency duration, low frequency duration, pulse width and amplitude of the waveform. The preset waveform signal includes at least one of the frequency, high frequency duration, low frequency duration, pulse width and amplitude of the waveform.

[0048] In some embodiments of the present application, the alarm may be an alarm speaker or an alarm light.

[0049] In some embodiments of the present application, the circuit board also includes an interference monitoring module, which includes a noise collector, a comparator, and a controller; the noise collector is used to collect the noise value of the environment, the comparator is used to compare the size between the noise value and the preset threshold, and the controller is used to control the host 1 to start according to the comparison result of the comparator. In this way, the noise value of the environment is collected by the noise collector, the size between the noise value and the preset threshold is compared by the comparator, and the controller confirms the operating state of the magnetic resonance imaging device according to the comparison result of the comparator, so that the controller can control the start and stop time of the vagus nerve stimulation device according to the startup state of the magnetic resonance imaging device, thereby improving the degree of automation of the vagus nerve stimulation device.

[0050] In some embodiments of the present application, when the noise value is greater than a preset threshold, the controller confirms that the magnetic resonance imaging device has been started and records the start-up time, and the controller controls the start-up time of the host 1 according to the start-up time of the magnetic resonance imaging device. For example, when the magnetic resonance imaging device is started, the controller can control the host 1 to start synchronously, or, when the magnetic resonance imaging device is started 60 seconds later, the controller can control the host 1 to start. When the noise value is less than the preset threshold, the controller confirms that the magnetic resonance imaging device is not started.

[0051] In some embodiments of the present application, the noise collector is also called an automatic noise monitoring instrument, which is mainly composed of a sound pressure sensor, an analog converter and a digital signal processor. The sound pressure sensor is used to measure the sound pressure level of the noise and convert it into an electrical signal. The analog converter is used to convert the analog electrical signal into a digital signal. The digital signal processor is used to process and analyze the digital signal according to a specific algorithm, and finally obtain the measurement result of the noise parameter.

[0052] In some embodiments of the present application, the controller is a microprocessor chip, which can be an integrated structure with the processing module.

[0053] In some embodiments of the present application, Figure 3 As shown, the vagus nerve stimulation device also includes a control handle 4 and a transmission line 5. The control handle 4 is located outside the housing 11 of the main unit. The control handle 4 is connected to the circuit board of the main unit through the transmission line 5. The control handle 4 includes a switch 41 and an intensity adjustment button 42. The switch 41 is used to control the on and off of the current between the main unit 1 and the electrode 2, and the intensity adjustment button 42 is used to adjust the magnitude of the stimulation current output by the main unit 1 to the electrode 2. In this way, when the main unit 1 transmits the stimulation current to the user through the electrode 2, the user can turn on or off the main unit 1 through the switch 41 on the control handle 4 according to his or her own feelings, or adjust the magnitude of the stimulation current output by the main unit 1 to the electrode 2 through the intensity adjustment button 42 on the control handle 4, so as to avoid the stimulation current being too high or too low to affect the therapeutic effect of the vagus nerve stimulation device.

[0054] In some embodiments of the present application, the circuit board further includes at least one of an overvoltage protection circuit, an overcurrent protection circuit, and an overheat protection circuit. In this way, the overvoltage protection of the circuit is realized by the overvoltage protection circuit, the overcurrent protection of the circuit is realized by the overcurrent protection circuit, and the overheat protection of the circuit is realized by the overheat protection circuit, which can improve the safety and stability of the circuit and avoid circuit failure of the vagus nerve stimulation device.

[0055] In some embodiments of the present application, the circuit board further includes a boost module, which is disposed between the pulse waveform modulation module and the output module and is used to boost the waveform pulse output by the pulse waveform modulation module. In this way, the waveform pulse output by the pulse waveform modulation module is boosted by the boost module, so that the stimulation voltage on the electrode 2 can meet the treatment requirements.

[0056] In some embodiments of the present application, the circuit board also includes a circuit breaker and a current limiter, and the circuit breaker and the current limiter are electrically connected to the processing module. When the processing module detects that the waveform signal of the stimulation current is abnormal, the processing module can control the circuit breaker to cut off the circuit, or control the current limiter to limit the current, thereby avoiding loss of the vagus nerve stimulation device or the patient and improving the safety of the vagus nerve stimulation device.

[0057] In some embodiments of the present application, the circuit board further includes a storage module, which is electrically connected to the processing module; the storage module is used to store at least one of the waveform parameters, current intensity, stimulation duration, and number of stimulations of the stimulation current output by the output module to the electrode 2. In this way, the waveform parameters, current intensity, stimulation duration, and number of stimulations of the stimulation current output by the output module to the electrode 2 are stored in the storage module, so that the staff can view the various parameters of the stimulation current, so that the staff can perform medical diagnosis on the patient according to the various parameters of the stimulation current.

[0058] In some embodiments of the present application, the waveform parameters may include waveform, frequency, pulse width, amplitude, etc.

[0059] In some embodiments of the present application, the circuit board also includes a transmission module, which is used to connect to a host computer to transmit the stored data in the storage module to the host computer, and the stored data includes at least one of the waveform parameters, current intensity, stimulation duration, and number of stimulations of the stimulation current output by the output module to the electrode 2. In this way, the staff can exchange data with the vagus nerve stimulation device through the host computer and the transmission module, which is convenient for the staff to input stimulation parameters to the processing module of the circuit board in the vagus nerve stimulation device through the host computer, and convenient for the staff to read the stored data in the storage module of the circuit board in the vagus nerve stimulation device through the host computer.

[0060] In some embodiments of the present application, the host computer is a computer that can directly issue control commands, such as a PC.

[0061] In some embodiments of the present application, the transmission module may be a wired transmission module or a wireless transmission module. When the transmission module is a wired transmission module, the host is connected to the host computer via a connection line; when the transmission module is a wireless transmission module, the wireless transmission module may be a Bluetooth module or a WIFI module, and the host is connected to the host computer via the wireless transmission module.

[0062] In some embodiments of the present application, the use process of the above-mentioned vagus nerve stimulation device may be:

[0063] First, the staff inputs the pulse width, frequency, on-off ratio, waveform mode, stimulation duration and other stimulation parameters into the processing module of the circuit board of the vagus nerve stimulation device through the host computer and the transmission module.

[0064] Secondly, the start-up time of the host is set; or the start-up time of the magnetic resonance imaging device is monitored by the interference monitoring module, and then the start-up time of the host is set according to the start-up time of the magnetic resonance imaging device.

[0065] After that, the patient is tested for current intensity. Specifically, the electrodes are put on the patient, and the staff slowly increases the current intensity until the patient feels stimulation. The current intensity at this time is the sensory threshold. Then, the staff continues to increase the current until it increases to 1.5 times the sensory threshold. If the patient feels obvious stimulation and no pain, this current intensity is used. If the patient feels pain during the increase, the maximum intensity under the pain threshold is the final stimulation intensity.

[0066] Afterwards, the control host starts to stimulate the vagus nerve of the patient with electric shock. Specifically, the electrodes are worn on the patient, and the processing module uses the current intensity tested above to output stimulation current to the electrodes. At this time, the magnetic resonance imaging device scans the patient to form a medical image.

[0067] Afterwards, during the electric shock stimulation, if the patient feels uncomfortable, the main unit can be turned on or off by the switch on the control handle, or the intensity of the stimulation current on the electrode can be adjusted by the intensity adjustment button on the control handle.

[0068] Finally, the staff extracts the stored stimulation data from the storage module of the circuit board and makes a medical diagnosis for the patient based on the stimulation data.

[0069] In the description of the present invention, it is necessary to understand that the terms "upper", "lower", "inside", "outside", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0070] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0071] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0072] The above contents are further detailed descriptions of the present invention in combination with specific preferred embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. For ordinary technicians in the technical field to which the present invention belongs, several simple deductions or substitutions can be made without departing from the concept of the present invention, which should be regarded as falling within the protection scope of the present invention.

Claims

1. A vagus nerve stimulation device compatible with a magnetic resonance environment, characterized in that: The device comprises a mainframe, electrodes and connecting wires, wherein two ends of the connecting wires are electrically connected to the mainframe and the electrodes respectively, and the mainframe comprises a housing and a circuit board arranged in the housing; The circuit board comprises a processing module and a power module electrically connected to the processing module, a pulse waveform modulation module and an output module, wherein the output module is electrically connected to the connecting wire; The processing module is used to control the power supply module to input current to the pulse waveform modulation module, control the pulse waveform modulation module to generate waveform pulses and transmit them to the output module, and control the output module to output stimulation current to the electrode through the connecting wire; The shell is a magnetic shielding shell, a through hole is provided on the shell, one end of the connecting wire passes through the through hole and is connected to the circuit board, a gasket is provided between the connecting wire and the through hole, and the gasket is a magnetic shielding gasket.

2. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The output module includes a low-pass filter circuit and an anti-radio frequency interference filter circuit.

3. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The connecting wires are twisted pair wires.

4. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The electrode comprises a contact head for contacting a human body, and the material of the contact head is conductive silicone.

5. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The circuit board also includes an interference monitoring module, which includes a noise collector, a comparator and a controller; The noise collector is used to collect the noise value of the environment, the comparator is used to compare the noise value with a preset threshold, and the controller is used to control the host to start according to the comparison result of the comparator.

6. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The circuit board also includes a waveform monitoring module, which includes a waveform detector and an alarm. The waveform detector is electrically connected to the output module, and both the waveform detector and the alarm are electrically connected to the processing module. The waveform detector is used to receive the stimulation current output by the output module and detect the waveform signal of the stimulation current. The processing module is used to control the alarm to turn on or off according to the difference between the waveform signal detected by the waveform detector and the preset waveform signal.

7. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: It also includes a control handle and a transmission line, wherein the control handle is located outside the housing of the host, the control handle is connected to the circuit board of the host through the transmission line, and the control handle includes a switch and an intensity adjustment button; The switch is used to control the on and off of the current between the host and the electrode, and the intensity adjustment button is used to adjust the magnitude of the stimulation current output by the host to the electrode.

8. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The circuit board also includes at least one of an overvoltage protection circuit, an overcurrent protection circuit and an overheat protection circuit.

9. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The circuit board also includes a boost module, which is arranged between the pulse waveform modulation module and the output module and is used to boost the waveform pulse output by the pulse waveform modulation module.

10. The magnetic resonance environment compatible vagus nerve stimulation device according to claim 1, characterized in that: The circuit board also includes a storage module, and the storage module is electrically connected to the processing module; The storage module is used to store stimulation parameters of the stimulation current output by the output module to the electrode, wherein the stimulation parameters include at least one of waveform parameters, current intensity, stimulation duration and number of stimulations; The circuit board also includes a transmission module, which is used to connect to a host computer to transmit the storage data in the storage module to the host computer, wherein the storage data includes stimulation parameters of the stimulation current output by the output module to the electrode.

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