A vagus nerve stimulation device

Abstract

The present invention discloses a vagus nerve stimulation device, comprising: a storage module, which is configured to store pulse data; an MCU main control module, which is electrically connected to the storage module and is used to generate a first sinusoidal signal according to the pulse data; a pulse generating module, which is electrically connected to the MCU main control module and is used to generate a pulse stimulation signal according to the first sinusoidal signal; an electrode, which is used to receive and output the pulse stimulation signal; and a power supply, which is electrically connected to the storage module, the MCU main control module and the pulse generating module respectively, and provides working voltage for the storage module, the MCU main control module and the pulse generating module.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a vagus nerve stimulation device. Background Art

[0002] The vagus nerve is the most widely distributed and longest of the twelve pairs of cranial nerves. It is a mixed nerve composed of about 20% efferent fibers and about 80% afferent fibers. It controls and dominates the functions of multiple organs, glands, involuntary muscles, etc. in the human body. Vagus nerve stimulation (VNS) refers to the technology of stimulating the vagus nerve. As the fastest-growing neuromodulation technology in the past 20 years, it has been approved by the FDA for the clinical treatment of drug-resistant epilepsy, severe depression, and obesity. In recent years, VNS has also shown good results in the treatment of heart failure, tinnitus, migraine, inflammation, anxiety, Alzheimer's disease, drug addiction, sepsis, cancer, fibromyalgia, autism and other diseases.

[0003] Please refer to Figure 1 , Figure 1 A pulse waveform diagram of a conventional vagus nerve stimulation device. Conventional vagus nerve stimulation devices typically generate square wave pulses with a fast rise time, which can cause a sharp tingling sensation in the user and become uncomfortable for a period of time. Summary of the invention

[0004] In view of the deficiencies of the prior art, a vagus nerve stimulation device is provided.

[0005] To achieve the above object, the present invention provides a vagus nerve stimulation device, comprising: a storage module, the storage module being configured to store pulse data;

[0006] The MCU main control module is electrically connected to the storage module and is used to generate a first sinusoidal signal according to the pulse data;

[0007] A pulse generating module, electrically connected to the MCU main control module, and configured to generate a pulse stimulation signal according to the first sinusoidal signal;

[0008] Electrodes, for receiving and outputting pulse stimulation signals; and

[0009] The power supply is electrically connected to the storage module, the MCU main control module and the pulse generation module respectively, and provides working voltage for the storage module, the MCU main control module and the pulse generation module.

[0010] According to one embodiment of the present invention, the pulse generation module comprises:

[0011] A boost circuit, the boost circuit is connected to the storage module, the MCU main control module and the power supply respectively; the boost circuit receives the power supply voltage of the power supply and generates a first signal; the boost circuit generates a second signal after receiving the power supply voltage of the power supply, and supplies power to the storage module and the MCU main control module respectively;

[0012] A driving circuit, the driving circuit is electrically connected to the boost circuit and receives the second signal; the driving circuit generates and sends a driving signal; and

[0013] The signal generating circuit is electrically connected to the boost circuit and receives the first signal. The signal generating circuit is also electrically connected to the drive circuit and receives the drive signal. The signal generating circuit is also connected to the MCU main control module and receives the first sinusoidal signal and then generates a pulse stimulation signal and outputs it to the electrode.

[0014] According to an embodiment of the present invention, the stimulation period T1 of the first sinusoidal signal is 1 ms, each stimulation period T1 includes ten pulses, each pulse has a duration of 100 us, and the interval between two adjacent pulses is 40 ms.

[0015] According to an embodiment of the present invention, it further includes a power management module, which is electrically connected to the MCU main control module and the boost circuit respectively.

[0016] According to an embodiment of the present invention, an adjusting button module is further included. The adjusting button module is connected to the MCU main control module, and the MCU main control module receives a control signal from the adjusting button module.

[0017] According to one embodiment of the present invention, the output voltage range of the pulse stimulation signal is 3.7V-51V.

[0018] According to an embodiment of the present invention, a voltage stabilizing module is further included, and the voltage stabilizing module is electrically connected to the boost circuit and the MCU main control module respectively.

[0019] According to one embodiment of the present invention, it also includes a first filtering unit, a second filtering unit and a third filtering unit; the first filtering unit is respectively connected to the boost circuit and the driving circuit; the second filtering unit is respectively connected to the boost circuit and the storage module; the third filtering unit is respectively connected to the voltage stabilizing module and the MCU main control module.

[0020] According to an embodiment of the present invention, an auxiliary connecting member is further included, and the auxiliary connecting member is connected to the signal generating circuit.

[0021] The beneficial effect of the present invention is that the pulse data is stored separately through the storage module. When in use, the MCU main control module calls the pulse data and generates a first sinusoidal signal, and the pulse generation module amplifies the first sinusoidal signal to form a pulse stimulation signal. The pulse stimulation signal and the first sinusoidal signal are both fixed sinusoidal AC pulse signals with a broadband amplitude modulation spectrum, which have a gradual rise time and a tilted peak and decline. Compared with the square wave pulse generated by the traditional vagus nerve stimulation device, it helps to reduce the sharp tingling sensation caused by the square wave pulse and effectively improves the user's sense of use. In addition, by using the storage module alone to store the pulse data separately, the pulse data is separated from other circuit modules, which effectively avoids the interference caused by electrical or noise caused by other circuits to the pulse data, and can effectively improve the accuracy of the output pulse stimulation signal. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0023] Figure 1 A graph of pulse waveforms generated for existing vagus nerve devices;

[0024] Figure 2 is a schematic diagram of the framework of the vagus nerve stimulation device in the embodiment;

[0025] Figure 3 is a waveform diagram of the duration of the pulse stimulation signal in the embodiment;

[0026] Figure 4 is a waveform diagram of the duration of the pulse stimulation signal;

[0027] Figure 5 It is a principle block diagram of a pulse generation module in the embodiment;

[0028] Figure 6 is a principle block diagram of a boost circuit in an embodiment;

[0029] Figure 7 4 is a schematic diagram of the framework of the vagus nerve stimulation device in the embodiment.

[0030] Description of Reference Numerals

[0031] 1-storage module; 2-MCU main control module; 3-pulse generation module; 4-electrode; 5-power supply; 31-boost circuit; 311-field effect tube; 312-power switch; 313-boost module; 314-rectifier module; 32-drive circuit; 33-signal generating circuit; 6-power management module; 7-adjustment button module; 8-voltage stabilizing module; 10-first filter unit; 20-second filter unit; 30-third filter unit; 71-first button module; 72-second button module; 73-third button module; 74-fourth button module. DETAILED DESCRIPTION

[0032] The following will disclose multiple embodiments of the present invention with drawings. For the purpose of clear description, many practical details will be described together in the following description. However, it should be understood that these practical details should not be used to limit the present invention. That is, in some embodiments of the present invention, these practical details are not necessary. In addition, for the purpose of simplifying the drawings, some conventional structures and components will be depicted in a simple schematic manner in the drawings.

[0033] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes, and do not specifically refer to the order or sequence, nor are they used to limit the present invention. They are only used to distinguish components or operations described with the same technical terms, and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0034] Please refer to Figure 2-Figure 4 , Figure 2 This is the schematic diagram of the vagus nerve stimulation device. Figure 3 is the waveform of the duration of the pulse stimulation signal, Figure 4 It is a waveform diagram of the frequency of the pulse stimulation signal. This embodiment provides a vagus nerve stimulation device, which includes a storage module 1, an MCU main control module 2, a pulse generating module 3, an electrode 4 and a power supply 5. Among them, the MCU main control module 2 is connected to the storage module 1, the pulse generating module 3 and the power supply 5 respectively. The MCU main control module 2 is used to adjust and control the storage module 1, the pulse generating module 3 and the power supply 5 to work together. The electrode 4 is connected to the pulse generating module 3, and the pulse stimulation signal is transmitted to the electrode 4 through a wire, and then transmitted to the user's skin through the electrode 4, thereby achieving a stimulating effect. In this example, two electrodes 4 are provided, and the two electrodes 4 are connected to the pulse generating module 3.

[0035] Furthermore, the storage module 1 is used to store pulse data. When in use, the MCU main control module 2 calls the pulse data in the storage module 1, and generates a first sinusoidal signal output according to the pulse data. The pulse generation module 3 is electrically connected to the MCU main control module 2, and after receiving the first sinusoidal signal, it generates a pulse stimulation signal output according to the first sinusoidal signal. The electrode 4 is used to receive and output the pulse stimulation signal, and the power supply 5 is electrically connected to the storage module 1, the MCU main control module 2 and the pulse generation module 3 respectively, and provides a power supply voltage for the storage module 1, the MCU main control module 2 and the pulse generation module 3, so that the storage module 1, the MCU main control module 2, and the pulse generation module 3 work normally.

[0036] It should be noted that the pulse data is a plurality of different sets of adjustment parameter information selected from the data on the effectiveness of stimulating the vagus nerve in existing public research. The plurality of different sets of adjustment parameter information are pre-stored in the storage module. When in use, the MCU main control module 2 retrieves the adjustment parameters from the storage module 1 and generates a first sinusoidal signal output of different intensities based on the data.

[0037] In this embodiment, the power source 5 is selected as a 3.7V rechargeable lithium iron battery. The MCU main control module 2 is a microcontroller of model STM32F103RCT6, which is used to generate the first sinusoidal signal, coordinate the work of each module, and manage data storage.

[0038] It should be noted that the pulse stimulation signal and the first sinusoidal signal are both fixed sinusoidal AC pulse signals with a broadband amplitude modulation spectrum, which have a gradual rise time and a sloping peak and fall. Compared with the square wave pulses generated by the traditional vagus nerve stimulation device, it helps to reduce the sharp tingling sensation caused by the square wave pulses and effectively improves the user's experience. In addition, by using the storage module 1 to store the pulse data separately, the pulse data is separated from other circuit modules, which effectively avoids the interference caused by electrical or noise caused by other circuits to the pulse data, and can effectively improve the accuracy of the output pulse stimulation signal.

[0039] Please refer to Figure 5 , Figure 5 : is a principle block diagram of the pulse generating module. Further, the pulse generating module 3 includes a boost circuit 31, a drive circuit 32 and a signal generating circuit 33. The boost circuit 31 is respectively connected to the storage module 1, the MCU main control module 2, the power supply 5, the drive circuit 32 and the signal generating circuit 33. The input end of the boost circuit 31 is connected to the power supply 5, which receives the supply voltage of the power supply 5, and then generates a first signal, which is transmitted to the signal generating circuit 33 to power the signal generating circuit 33.

[0040] The supply voltage of the power supply 5 is also converted into a second signal after passing through the boost circuit 31 , and the second signal is respectively input into the storage module 1 , the MCU main control module 2 and the drive circuit 32 to supply power to the storage module 1 , the MCU main control module 2 and the drive circuit 32 .

[0041] The driving circuit 32 is connected to the signal generating circuit 33 and is used to provide a driving signal to the signal generating circuit 33 so that the signal generating circuit 33 can operate normally.

[0042] In actual use, the boost circuit 31 receives the supply voltage of the power supply 5 and increases the supply voltage to meet the power supply requirements of the vagus nerve stimulation device. The drive circuit 32 provides a drive signal to the signal generating circuit 33 to enable the signal generating circuit 33 to work. The MCU main control module 2 retrieves the pulse data from the storage module 1, generates a first sinusoidal signal based on the pulse data, and sends the first sinusoidal signal to the signal generating circuit 33. The first sinusoidal signal passes through the signal generating circuit 33 to form a pulse stimulation signal output. The pulse stimulation signal is released to the surface of the user's skin through the electrode 4, so that the user's vagus nerve is stimulated by the pulse stimulation signal, thereby achieving a therapeutic effect.

[0043] Please refer to Figure 6 , Figure 6 : is a principle block diagram of a boost circuit. The boost circuit 31 includes a field effect tube 311, a power switch 312, a boost module 313 and a rectifier module 314, wherein the drain D of the field effect tube 311 is connected to the positive electrode of the power supply 5, the gate G of the field effect tube 311 is connected to the negative electrode of the power supply 5, and the source S of the field effect tube 311 outputs a first signal. The source S of the field effect tube 311 is also connected to the power switch, and the power switch 312 is used to control the on-off state of the field effect tube 311, so that the power supply 5 is in a power supply or power suspension state. The power switch 312 is also connected to the boost module 313, and the boost module 313 is used to boost the electrical signal output by the power switch 312. The output end of the boost module 313 is connected to the input end of the rectifier module 314, so that the electrical signal outputs a second signal after passing through the rectifier module 314.

[0044] Furthermore, the amplitude of the pulse stimulation signal output by the vagus nerve stimulation device is adjustable, and the adjustable range is 3.7V-51V. In this embodiment, the pulse stimulation signal output by the vagus nerve stimulation device is divided into ten adjustable levels, and each level differs by 5V. The amplitudes of the ten levels of pulse stimulation signals are 3.7V, 8.7V, 13.7V, 18.7V, 23.7V, 28.7V, 33.7V, 38.7V, 43.7V and 51V respectively. By setting different amplitudes of the pulse stimulation signal, the vagus nerve stimulation device can make stimulations of different intensities according to different usage requirements, and can be applied to more different usage scenarios.

[0045] Furthermore, the stimulation period T1 of the first sinusoidal signal is set to 1 ms, each stimulation period T1 includes ten pulses, each pulse lasts for 100 us, and each pulse continuously generates the first sinusoidal signal at an interval of 40 ms. The first sinusoidal signal thus generated has an accurate and reliable pulse signal, and the vagus nerve is effectively stimulated.

[0046] Please refer to Figure 7 , Figure 7 It is a schematic diagram of the framework of the vagus nerve stimulation device. The vagus nerve stimulation device also includes a power management module 6, which is electrically connected to the MCU main control module 2 and the boost circuit 31 respectively. In this embodiment, the power management module 6 includes a USB port, a battery charging management chip and a battery management chip. The battery charging management chip is of the MCP73831T-2ATI / MC model. The USB port is connected to the battery charging management chip, and the battery charging management chip is connected to the MCU main control module 2, which is controlled by the MCU main control module 2. The BAT terminal of the battery charging management chip is connected to the source of the field effect transistor in the boost circuit 31. The battery charging management chip acts on the power supply 5, and it monitors and controls the charging current, voltage and other parameters of the power supply 5 to achieve safe management of the charging process. The power management chip is connected to the MCU main control module 2 and the boost module respectively. The power management chip adopts the MAX17260SETD model. The BAT end of the battery management chip is connected to the source of the field effect transistor in the boost circuit 31. The battery management chip is used for monitoring and control functions related to the power supply 5, including battery balancing, status monitoring, power metering, short circuit protection, overvoltage and undervoltage protection, etc.

[0047] Please refer to Figure 5 The vagus nerve stimulation device also includes an adjustment button module 7, which is connected to the MCU main control module 2, and the MCU main control module 2 receives the control signal of the adjustment button module 7. The adjustment button module 7 includes a first button module 71, a second button module 72, a third button module 73 and a fourth button module 74. The first button module 71, the second button module 72 and the third button module 73 are respectively connected to the MCU main control module 2, wherein the first button module 71 is used to control the switch of the vagus nerve stimulation device, the second button module 72 increases the intensity of the first sinusoidal signal emitted by the vagus nerve stimulation device, the third button module 73 is used to reduce the intensity of the first sinusoidal signal emitted by the vagus nerve stimulation device, and the fourth button module 74 is used to switch the use mode. By setting the adjustment button module 7, the user can control the vagus nerve stimulation device according to the use requirements.

[0048] In this embodiment, the first button module 71 , the second button module 72 , the third button module 73 and the fourth button module 74 are all light-touch button switches.

[0049] In actual use scenarios, the vagus nerve device is activated by pressing the first button module 71, and then the use mode is switched by pressing the fourth button, and the use mode is switched once each time the fourth button module 74 is pressed. After selecting the use mode, the stimulation intensity is adjusted by the second button module 72 and the third button module 73 until a comfortable intensity is found.

[0050] The vagus nerve stimulation device in this embodiment has two usage modes, namely continuous mode and timing mode. The user can switch the usage mode by pressing the fourth button. Among them, the timing mode is to perform stimulation treatment within a specified time. The setting time of the timing mode in this example is 150 seconds. When using this mode, the vagus nerve stimulation device operates normally within 150 seconds, and the vagus nerve stimulation device automatically stops after 150 seconds. In the continuous mode, the vagus nerve stimulation device continues to output pulse stimulation signals until the user presses the pause button.

[0051] Further, the vagus nerve stimulation device also includes a sound prompt module (not shown in the figure), which is electrically connected to the signal generating circuit 33. In this embodiment, the sound prompt module is a patch buzzer. During use, when the intensity of the pulse stimulation signal needs to be adjusted, the second button module 72 is pressed to increase the intensity or the third button module 73 is pressed to reduce the intensity, so that the pulse stimulation signal changes, and the sound prompt module emits a sound as the intensity of the pulse signal changes, thereby prompting the user that the vagus nerve changes state.

[0052] The vagus nerve stimulation device also includes a voltage stabilizing module 8, which is connected to the boost circuit 31 and the MCU main control module 2 respectively. The voltage stabilizing module 8 is used to maintain the stability of the voltage signal of the MCU main control module 2. The first signal output by the boost circuit 31 is output to the MCU main control module 2 after passing through the voltage stabilizing module 8, providing low noise and low static current for the MCU main control module 2, effectively reducing the interference of noise on the output pulse, so that the pulse accuracy of the output of the vagus nerve stimulation device is improved. In this embodiment, the voltage stabilizing module 8 includes a linear regulator with a model number of TPS7A0230PDBVR.

[0053] In addition, the vagus nerve stimulation device in this embodiment further includes a first filter unit 10, a second filter unit 20 and a third filter unit 30. The first filter unit 10 is connected to the boost circuit 31 and the drive circuit 32 respectively, and the second signal output by the boost circuit 31 is input to the drive circuit 32 after passing through the first filter unit 10. The second filter unit 20 is connected to the boost circuit 31 and the storage module 1 respectively, and the second signal output by the boost circuit 31 is input to the storage module 1 after passing through the second filter unit 20. The third filter unit 30 is connected to the voltage stabilizing module 8 and the MCU main control module 2 respectively, and the first signal output by the boost circuit 31 is input to the voltage stabilizing module 8, and then is output to the MCU main control module 2 after passing through the voltage stabilizing module 8 and the third filter unit 30 in sequence.

[0054] The vagus nerve stimulation device further includes a fourth filtering unit 40, which is respectively connected to the boost circuit 31 and the power management module 6. In this example, the fourth filtering unit 40 is respectively connected to the boost circuit 31 and the USB port. When the vagus nerve stimulation device is connected to an external power source through the USB port for charging, the fourth filtering unit 40 filters the current to stabilize the charging current.

[0055] The first filter unit 10 , the second filter unit 20 , the third filter unit 30 and the fourth filter unit 40 are all used to filter high-frequency signals, which can effectively suppress abnormal frequencies and noises in the circuit, so that the circuit has good stability.

[0056] In actual use, the two electrodes 4 are placed vertically and attached to the vagus nerve in the user's neck, with one electrode 4 at the top and the other electrode 4 at the bottom. Then, the use mode is selected through the fourth button, and then the vagus nerve stimulation device is turned on, and the intensity is adjusted through the second and third buttons. In the process of gradually increasing intensity, once the user feels a downward pull on the lips or ears, the user can reduce the stimulation intensity until a comfortable intensity is found and maintained at this position. The pulse stimulation signal is transmitted to the vagus nerve in the neck through the electrode 4, thereby stimulating the vagus nerve system and achieving the purpose of treatment.

[0057] The vagus nerve stimulation device in this embodiment can also be used to stimulate other peripheral nerves. When in use, the two electrodes 4 can be attached to other parts to stimulate nerves in other parts.

[0058] In addition, in order to improve the usability of the vagus nerve stimulation device, the vagus nerve stimulation device in this embodiment also includes an auxiliary connector, which is connected to the signal generating circuit 33. The auxiliary connector is used to connect external auxiliary accessories, such as ear-worn accessories. In this embodiment, the auxiliary connector is a 3.5mm single socket, and the external auxiliary accessories are connected to the auxiliary connector. During use, the pulse stimulation signal generated by the signal generating circuit 33 is released through the external auxiliary accessories, so that the vagus nerve stimulation device can be applied to more different usage scenarios.

[0059] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A vagus nerve stimulation device, characterized in that: include: A storage module (1), wherein the storage module (1) is configured to store pulse data; An MCU main control module (2) is electrically connected to the storage module (1) and is used to generate a first sinusoidal signal according to the pulse data; A pulse generating module (3), electrically connected to the MCU main control module (2), and configured to generate a pulse stimulation signal according to the first sinusoidal signal; An electrode (4) for receiving and outputting the pulse stimulation signal; as well as A power supply (5) is electrically connected to the storage module (1), the MCU main control module (2) and the pulse generation module (3) respectively, and provides a working voltage for the storage module (1), the MCU main control module (2) and the pulse generation module (3); The pulse generating module (3) comprises: a boost circuit (31), the boost circuit (31) being connected to the storage module (1), the MCU main control module (2) and the power supply (5) respectively; the boost circuit (31) receiving the power supply voltage of the power supply (5) and generating a first signal; the boost circuit (31) generating a second signal after receiving the power supply voltage of the power supply (5), and supplying power to the storage module (1) and the MCU main control module (2) respectively; A drive circuit (32), the drive circuit (32) being electrically connected to the boost circuit (31) and receiving a second signal; the drive circuit (32) generating and sending a drive signal; and A signal generating circuit (33), wherein the signal generating circuit (33) is electrically connected to the boost circuit (31) and receives a first signal, and the signal generating circuit (33) is also electrically connected to the drive circuit (32), and the signal generating circuit (33) receives the drive signal; the signal generating circuit (33) is also connected to the MCU main control module (2), and the signal generating circuit (33) receives a first sinusoidal signal and then generates a pulse stimulation signal and outputs it to the electrode (4).

2. The vagus nerve stimulation device according to claim 1, characterized in that: The stimulation period T1 of the first sinusoidal signal is 1 ms. Each stimulation period T1 includes ten pulses. The duration of each pulse is 100 us, and the interval between two adjacent pulses is 40 ms.

3. The vagus nerve stimulation device according to claim 1, characterized in that: It also includes a power management module (6), which is electrically connected to the MCU main control module (2) and the boost circuit (31) respectively.

4. The vagus nerve stimulation device according to claim 1, characterized in that: It also comprises an adjusting key module (7), wherein the adjusting key module (7) is connected to the MCU main control module (2), and the MCU main control module (2) receives a control signal from the adjusting key module (7).

5. The vagus nerve stimulation device according to claim 1, characterized in that: The output voltage range of the pulse stimulation signal is 3.7V-51V.

6. The vagus nerve stimulation device according to claim 1, characterized in that: It also includes a voltage stabilizing module (8), which is electrically connected to the voltage boosting circuit (31) and the MCU main control module (2) respectively.

7. The vagus nerve stimulation device according to claim 6, characterized in that: The invention also comprises a first filtering unit (10), a second filtering unit (20) and a third filtering unit (30); the first filtering unit (10) is respectively connected to the boost circuit (31) and the driving circuit (32); the second filtering unit (20) is respectively connected to the boost circuit (31) and the storage module (1); and the third filtering unit (30) is respectively connected to the voltage stabilizing module (8) and the MCU main control module (2).

8. The vagus nerve stimulation device according to claim 1, characterized in that: It also includes an auxiliary connecting piece, which is connected to the signal generating circuit (33).

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