Vagus nerve stimulation device and preparation method thereof

Abstract

The invention relates to a vagus nerve stimulation device and a preparation method thereof. The vagus nerve stimulation device comprises an electrical stimulation unit and a hard base shell. The electrical stimulation unit comprises a pulse generation module and an electrode electrically connected with the pulse generation module; the hard base shell is at least used for the electrodes to be arranged on so as to bear the electrodes. Wherein the hard base shell is suitable for being attached to the neck of a human body, so that the electrodes are in contact with the skin of the neck to output an electric stimulation signal to stimulate the vagus nerve of the neck. The vagus nerve stimulation device provided by the invention is integrally miniaturized, is convenient to carry and use, and has the characteristics of compact structure, comfort in wearing, convenience in use and reusability.

Description

Technical Field

[0001] This application relates to the field of neurostimulation device technology, and in particular to a vagus nerve stimulation device and its preparation method. Background Technology

[0002] Vagus nerve stimulation (VNS), as a neuromodulation technique, has been widely used in the treatment and rehabilitation of diseases such as epilepsy and depression. Traditional VNS stimulators are mostly implantable devices. While these devices have proven efficacy, they suffer from drawbacks such as significant surgical trauma, high cost, and high risk of infection, limiting their application.

[0003] To lower the barrier to entry and avoid surgical risks, non-invasive vagus nerve stimulation (VAS) technology has been developed. Currently, most commercially available VAS stimulators primarily target the vagus nerve branches in the ear, and these devices are typically designed as ear clips or earphones. However, ear VAS stimulation has limitations such as indirect target stimulation and weak stimulation effects. In contrast, directly stimulating the cervical vagus nerve trunk is more direct, but the development and commercial application of such products are relatively limited.

[0004] Existing vagus nerve stimulation devices are often bulky and inconvenient to wear, resulting in poor portability, the need for manual holding during use, or insecure fixation affecting the stimulation effect and a poor user experience. This is mainly because achieving miniaturization, stable attachment, and effective stimulation of the device in the neck area, which is frequently used and requires high comfort, presents technical challenges.

[0005] Therefore, it is necessary to propose a new technical solution to overcome the shortcomings of existing technologies. Summary of the Invention

[0006] Based on this, this application provides a compact and easy-to-use vagus nerve stimulation device and its preparation method.

[0007] Therefore, this application adopts the following technical solution: a vagus nerve stimulation device, comprising:

[0008] An electrical stimulation unit includes a pulse generation module and electrodes electrically connected to the pulse generation module;

[0009] A rigid substrate, at least for accommodating the electrodes thereon to support the electrodes;

[0010] The rigid base shell is attached to the neck of the human body with adhesive so that the electrodes come into contact with the skin of the neck and output electrical stimulation signals to stimulate the vagus nerve in the neck.

[0011] In some embodiments, the rigid substrate is a metal part or a rigid plastic part.

[0012] In some embodiments, the rigid substrate is provided with an electrode mounting groove, and the electrode is disposed in the electrode mounting groove.

[0013] In some embodiments, the electrode is a metal electrode.

[0014] In some embodiments, the vagus nerve stimulation device further includes an adhesive layer disposed on the rigid substrate for adhesion to the skin of the neck.

[0015] In some embodiments, the rigid substrate is provided with an adhesive layer mounting groove, and the adhesive layer is disposed in the adhesive layer mounting groove.

[0016] In some embodiments, both the electrode mounting groove and the adhesive layer mounting groove are located on the side of the rigid base shell that contacts the human neck. There are two electrode mounting grooves, located at both ends of the rigid base shell, and the adhesive layer mounting groove is located between the two electrode mounting grooves.

[0017] In some embodiments, the electrode is adhesive to adhere the rigid substrate to the skin of the neck.

[0018] In some embodiments, the electrode is a conductive gel or a conductive double-sided adhesive.

[0019] In some embodiments, a conductive reinforcement layer is further disposed between the electrode and the rigid substrate, and the conductive reinforcement layer is electrically connected to the electrode.

[0020] In some embodiments, the conductive enhancement layer comprises a graphite film or a metal film.

[0021] In some embodiments, the pulse generation module includes a circuit board.

[0022] In some embodiments, the rigid housing has an inner side facing the neck skin and an outer side facing away from the neck skin when in use, the electrode is located on the inner side of the rigid housing, the circuit board is located on the outer side of the rigid housing, and the two are electrically connected through a conductive portion passing through the rigid housing.

[0023] In some embodiments, the conductive part is a wire or a conductive terminal.

[0024] In some embodiments, the pulse generating module further includes a protective housing for protecting the circuit board.

[0025] In some embodiments, the protective shell is assembled onto the rigid base shell to form a box structure, and the circuit board is located inside the box structure.

[0026] In some embodiments, the protective shell is fitted onto the outside of the circuit board to cover the circuit board, or the protective shell is formed on the outside of the circuit board by a sealing process to encapsulate the circuit board.

[0027] In some embodiments, the rigid base shell or protective shell is provided with control keys for triggering the circuit board to perform set functions. The control keys include one or more of the following: power on key, power off key, and stimulation intensity adjustment key. The control keys are in the form of one or more of the following: touch type, tactile type, and dial type.

[0028] In some embodiments, the pulse generating module includes a battery electrically connected to the circuit board, and the battery is one or more of a disposable battery, a rechargeable battery, and a charging capacitor.

[0029] In some embodiments, the rigid base shell or protective shell is provided with a rechargeable interface, and the circuit board is electrically connected to the rechargeable interface; and / or, the circuit board is provided with a wireless charging coil.

[0030] In some embodiments, the number of electrodes is even, used to output stimulation signals to the neck skin and form a circuit.

[0031] This application also adopts the following technical solution: a method for preparing a vagus nerve stimulation device, used to prepare the vagus nerve stimulation device as described above, the preparation method comprising the following steps:

[0032] S1. Provide a rigid base shell;

[0033] S2. Provide an electrical stimulation unit, the electrical stimulation unit including a pulse generation module and electrodes electrically connected to the pulse generation module;

[0034] S3. At least the electrodes are arranged on the rigid substrate so that when the rigid substrate is attached to the neck of a human body, the electrodes contact the skin of the neck and output electrical stimulation signals to stimulate the vagus nerve in the neck.

[0035] The vagus nerve stimulation device provided in this application has a rigid base shell, and the electrodes of the electrical stimulation unit are disposed on the rigid base shell. The rigid base shell is suitable for being attached to the neck of the human body so that the electrodes contact the skin of the neck and output electrical stimulation signals to stimulate the vagus nerve in the neck. The device is designed to be miniaturized, easy to carry and use, and has the characteristics of compact structure, comfortable to wear, convenient to use and reusable. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0037] Figure 1 This is a perspective view of Embodiment 1 of the vagus nerve stimulation device of this application.

[0038] Figure 2 This is a perspective view of another embodiment of the vagus nerve stimulation device of this application.

[0039] Figure 3 This is a three-dimensional exploded view of Embodiment 1 of the vagus nerve stimulation device of this application.

[0040] Figure 4 This is a perspective view of Embodiment 2 of the vagus nerve stimulation device of this application.

[0041] Figure 5 This is a perspective view of another embodiment of the vagus nerve stimulation device of this application.

[0042] Figure 6 This is a three-dimensional exploded view of Embodiment 2 of the vagus nerve stimulation device of this application.

[0043] The components are labeled as follows: Protective shell: 101, 201; Battery: 102, 202; Circuit board: 103, 203; Rigid base shell: 104, 204; Electrode mounting slot: 1041, 2041; Adhesive layer mounting slot: 1042; Electrode: 105, 205; Adhesive layer: 106. Detailed Implementation

[0044] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0045] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0046] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0047] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0048] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0049] This application provides a vagus nerve stimulation device, aiming to provide a compact, portable, and easy-to-use non-invasive medical or personal health device that can be stably attached to the neck to directly and effectively electrically stimulate the vagus nerve trunk in the neck. By integrating electrodes onto a rigid substrate, this device achieves miniaturization and integration, overcoming the problems of large size, inconvenient wearing, and unstable fixation of traditional neck stimulation devices. The vagus nerve stimulation device of this application will be described in detail below with reference to the accompanying drawings and several embodiments.

[0050] Example 1

[0051] Please see Figures 1 to 3The diagram illustrates a schematic structure of a vagus nerve stimulation device according to a first embodiment of this application. The vagus nerve stimulation device includes an electrical stimulation unit and a rigid housing 104. The electrical stimulation unit includes a pulse generation module and electrodes 105 electrically connected to the pulse generation module. The rigid housing 104 is at least configured to accommodate and support the electrodes 105. The rigid housing 104 is adapted to be attached to the neck of a human body so that the electrodes 105 contact the neck skin and output electrical stimulation signals to stimulate the vagus nerve in the neck.

[0052] The core function of the electrical stimulation unit is to generate and output controllable electrical pulse signals, which mainly includes a pulse generation module and electrodes 105. The pulse generation module further includes a battery 102 that provides power, a circuit board 103 for controlling pulse parameters and output, and a protective structure for protecting the circuit board 103. The electrodes 105 serve as the physical output end of the electrical pulses and are in direct contact with the user's neck skin. The rigid base shell 104 constitutes the main support structure of the device, and the electrodes 105 are directly arranged on the rigid base shell 104. When the user attaches the device to the area on the neck corresponding to the passage of the vagus nerve trunk through the rigid base shell 104, the electrodes 105 can make good contact with the skin. The circuit board 103 operates under the power of the battery 102, generating a specific electrical pulse sequence. This electrical pulse is transmitted to the electrodes 105 through a conductive path, and then conducted through the skin and subcutaneous tissue to the target vagus nerve, thereby achieving non-invasive electrical stimulation of the nerve. This integrated design of the electrode 105 and the rigid base shell 104 makes the entire device very compact, eliminating the need for additional straps or handheld attachments, thus greatly improving portability and ease of use.

[0053] Please see Figure 3As shown, in this embodiment, the rigid base shell 104 serves as the supporting body, preferably a rigid shell, such as a metal part or a hard plastic part, which can play a good role in bearing, supporting, and protecting the electrostimulation unit on it, and is not easily deformed or damaged after long-term use, thus improving the durability of the device. The rigid base shell 104 is provided with an electrode mounting groove 1041, and the electrode 105 is disposed within the electrode mounting groove 1041. Specifically, to ensure that the electrode 105 is fixed in position on the rigid base shell 104 and to prevent the electrode 105 from shifting due to neck movement during use and affecting the stimulation effect, in this embodiment, the rigid base shell 104 has an electrode mounting groove 1041 on its inner surface facing the neck skin during use, and the electrode 105 is embedded in this electrode mounting groove 1041. This design not only makes the installation of the electrode 105 more secure and reliable, but also ensures that the contact surface of the electrode 105 and the inner surface of the rigid base shell 104 maintain a relatively flat or slightly protruding relationship, optimizing the contact state between the electrode 105 and the skin. In this embodiment, the electrode 105 is a metal electrode with good conductivity, such as stainless steel, silver, or gold-plated electrode sheet, to ensure low-impedance electrical signal transmission.

[0054] The metal electrodes used in this embodiment typically lack adhesive properties, making it impossible to firmly attach the entire device to the neck skin. Therefore, in this embodiment, the vagus nerve stimulation device also includes a separate adhesive layer 106. That is, the vagus nerve stimulation device includes an adhesive layer 106, which is disposed on the rigid base shell 104 for adhesion to the neck skin. In this embodiment, the adhesive layer 106 is also disposed on the inner surface of the rigid base shell 104, occupying most of the inner surface of the rigid base shell 104 except for the electrode 105, to provide sufficient area to ensure reliable adhesion. In this embodiment, the adhesive layer 106 can be medical-grade pressure-sensitive adhesive or other biocompatible adhesives, providing sufficient adhesion to firmly attach the rigid base shell 104 and the entire device to the user's neck skin, preventing the device from falling off or accidentally moving, thereby ensuring the accuracy and continuity of the stimulation position. To enhance adhesion reliability, conductive double-sided adhesive can also be applied to the metal electrode. One side of the conductive double-sided adhesive is attached to the metal electrode, and the other side is used to adhere to the neck skin. The conductive double-sided adhesive provides adhesion without affecting the output of the electrical stimulation signal from the electrode 105. Furthermore, in this embodiment, the rigid base shell 104 is provided with an adhesive layer mounting groove 1042, and the adhesive layer 106 is disposed within the adhesive layer mounting groove 1042. The adhesive layer mounting groove 1042 is a recessed structure, and the adhesive layer 106 is embedded within this recessed structure, ensuring that the adhesive layer 106 is fixed in position on the rigid base shell 104, preventing displacement of the adhesive layer 106 during use due to neck movement and thus affecting the adhesion effect. In this embodiment, both the electrode mounting groove 1041 and the adhesive layer mounting groove 1042 are located on the side of the rigid base shell 104 that contacts the human neck. There are two electrode mounting grooves 1041, located at opposite ends of the rigid base shell 104, and the adhesive layer mounting groove 1042 is located between the two electrode mounting grooves 1041. This separate and independent design of the electrode 105 and the adhesive layer 106 allows the electrode 105 to be independently made of high-performance metal materials to ensure long-term conductivity stability, while the adhesive layer 106 can be individually optimized for adhesion and biocompatibility. Furthermore, it allows users to easily replace the adhesive layer 106 after several uses to restore adhesion, enabling the device to be reused and complying with environmental protection and economic principles.

[0055] Please continue reading. Figure 3As shown, in this embodiment, the pulse generating module includes electrical components such as a circuit board 103 and a battery 102, and may further include a protective shell 101 for protecting the circuit board 103 and battery 102. In this embodiment, the protective shell 101 is assembled onto the rigid base shell 104 to form a box structure, and the circuit board 103 and battery 102 are located inside the box structure. The protective shell 101 can be an independent component, assembled onto the outer surface of the rigid base shell 104 facing away from the neck skin by means of clips, screws, or ultrasonic welding, forming a sealed or substantially sealed box structure together with the rigid base shell 104 to safely house the circuit board 103 and battery 102. The protective shell 101 is assembled outside the circuit board 103 to cover the circuit board 103. This assembled protective shell 101 facilitates production assembly and subsequent maintenance; the circuit board 103, battery 102, and other components inside can be repaired by removing the protective shell 101. The protective shell 101 can also be configured as an integral part of the rigid base shell 104. The protective function can also be achieved through other processes, such as directly covering the circuit board 103 and battery 102 with a film, or using encapsulation processes such as dripping or potting to form a cured protective layer on their exterior. In one embodiment, the protective shell 101 is formed on the exterior of the circuit board 103 through an encapsulation process to cover the circuit board 103, thereby achieving integrated encapsulation, which can further improve the sealing and reliability of the device.

[0056] In this embodiment, the rigid base shell 104 has an inner side facing the neck skin and an outer side facing away from the neck skin during use. The electrode 105 is located on the inner side of the rigid base shell 104, and the circuit board 103 is located on the outer side of the rigid base shell 104. The two are electrically connected through a conductive portion passing through the rigid base shell 104. In this embodiment, the circuit board 103 and the electrode 105 are respectively disposed on both sides of the rigid base shell 104, making it more flat and comfortable when attached to the neck, reducing the feeling of foreign objects. To achieve electrical connection, the circuit board 103 and the electrode 105 are electrically connected via a conductive portion passing through the rigid substrate 104. This conductive portion can be a flexible wire, with one end soldered or crimped onto the output pad of the circuit board 103 and the other end connected to the electrode 105. Alternatively, the conductive portion can be a rigid conductive terminal, such as a copper pillar or spring pin, with one end inserted into a conductive hole or connector in the circuit board 103 and the other end passing through a pre-drilled hole in the rigid substrate 104 to connect to the electrode 105. This layout cleverly utilizes the thickness of the rigid substrate 104, achieving separation between the circuitry and the skin contact portion, thus optimizing the overall structure. One end is fixed to the circuit board 103, and the other end passes through the rigid substrate 104 to contact and connect with the electrode 105.

[0057] To enable user control of the device, control keys are provided on the rigid base shell 104 or the aforementioned protective shell 101. These control keys trigger the circuit board 103 to execute preset functions. The control keys include one or more of the following: a power button, a power off button, and a stimulation intensity adjustment button. The control keys can be in the form of touch-sensitive, tactile, or DIP switch-type buttons. For example, touch-sensitive buttons can be used, allowing users to control the device by touching a specific area without physical travel, which helps maintain the flatness of the device surface; miniaturized physical buttons such as tactile switches or DIP switches can also be used. The inclusion of these control keys allows users to conveniently operate the device without connecting external equipment, enhancing user autonomy and convenience.

[0058] The device is powered by battery 102, which is electrically connected to circuit board 103. Battery 102 can be one or more of a disposable battery, a rechargeable battery, or a rechargeable capacitor. Battery 102 can be a disposable battery, such as a small, high-energy-density silver-zinc battery, suitable for products requiring single use or with a long service life. To support reusability, battery 102 is preferably a rechargeable battery, such as a lithium polymer battery, or a rechargeable capacitor. When using a rechargeable solution, a rechargeable interface, such as a micro USB interface, a Type-C interface, or magnetic charging contacts, can be provided on the rigid base shell 104 or protective shell 101. Circuit board 103 is electrically connected to this interface, allowing users to charge the device via a wired connection. For higher integration and waterproofing, a wireless charging coil can also be integrated on circuit board 103 to support wireless charging, achieving charging without exposed interfaces and improving product durability and aesthetics.

[0059] To ensure that the stimulation current forms an effective circuit, the number of electrodes 105 is usually set to an even number, such as two or more even numbers. These electrodes are all arranged in the target area on the same side of the neck. The electrical pulse is output from one of the electrodes 105, flows through the human tissue, and returns from the other electrode 105, forming a complete stimulation circuit, thereby generating an effective electric field stimulation of the vagus nerve located between the two electrodes 105.

[0060] Example 2

[0061] Please see Figures 4 to 6 This illustration shows a schematic structure of Embodiment 2 of the vagus nerve stimulation device of this application. Embodiment 2 is consistent with Embodiment 1 in overall concept and basic structure, including a rigid base shell 204 and an electrical stimulation unit containing electrical components such as a circuit board 203 and a battery 202. The main difference lies in the structure and functional integration of the electrode portion. In this Embodiment 2, the electrode 205 is adhesive, serving as an adhesive layer to adhere the rigid base shell 204 to the skin of the neck.

[0062] Specifically, in this embodiment, instead of using separate metal electrodes and adhesive layers, a material with both conductivity and adhesion is employed to simultaneously achieve the electrode 205 and adhesive fixation functions. In this embodiment, the electrode 205 is a conductive gel or conductive double-sided adhesive. Conductive gel has good biocompatibility, conductivity, and moderate adhesion, ensuring low-resistance contact with the skin while providing a comfortable wearing experience. It can be applied directly, molded, or pre-formed and then attached to the rigid base shell 204. Another feasible option is conductive double-sided adhesive, with one side adhering to the rigid base shell 204 and the other side used to adhere to the skin and conduct current.

[0063] In this design, electrodes 205 are directly fixed, adhered, or coated onto the inner surface of the rigid base shell 204. When the device is attached to the neck, electrodes 205 act as an adhesive layer, using their own adhesiveness to firmly adhere the entire device to the skin without the need for an additional separate adhesive layer. Simultaneously, they function as electrodes connected to the output terminal of the circuit board 203 via conductors, directly transmitting electrical pulses to the skin. This integrated design simplifies the device's structural hierarchy, reduces the number of components, and lowers assembly complexity. Furthermore, materials such as conductive gels are generally softer and more comfortable to the skin than metal electrodes, and they better adapt to uneven skin surfaces, providing a larger and more uniform current contact area, potentially contributing to improved user comfort and stimulation efficiency.

[0064] Furthermore, a conductive reinforcement layer is provided between the electrode 205 and the rigid substrate 204. To ensure low impedance and high reliability of the electrical connection from the circuit board 203 to the electrode 205, a conductive reinforcement layer can be added at the interface between the electrode 205 and the rigid substrate 204. This conductive reinforcement layer can be a highly conductive flexible film, such as a graphite film or a metal film. The conductive reinforcement layer can be laid over a large area on the inner surface of the rigid substrate 204, and then the conductive gel electrode 205 is coated or pasted onto it. The current output from the circuit board 203 is first transmitted to the conductive reinforcement layer through the wires, and then uniformly conducted to the entire electrode 205 area by the conductive reinforcement layer, making the current distribution more uniform, avoiding edge effects and local hot spots, and improving the safety and effectiveness of stimulation. In this embodiment, the rigid substrate 204 also has an electrode mounting groove 2041 on the inner side facing the neck skin during use. This conductive gel electrode 205 is embedded in this electrode mounting groove 2041, which can better ensure the stability of the shape and position of the electrode 205.

[0065] In this embodiment, except for the specific form of the electrode 205 which differs from that in Embodiment 1, the protective shell 201, battery 202, circuit board 203 and other components included in the device are the same as those in Embodiment 1. Their specific structures can be understood by referring to the description of Embodiment 1 above, and will not be repeated here.

[0066] Finally, this application also provides a method for preparing the vagus nerve stimulation device described in any of the above embodiments. The preparation method generally includes three main steps: S1, providing a rigid substrate; S2, providing an electrical stimulation unit, the electrical stimulation unit including a pulse generating module and electrodes electrically connected to the pulse generating module; S3, at least arranging the electrodes on the rigid substrate so that when the rigid substrate is attached to the neck of a human, the electrodes contact the neck skin and output electrical stimulation signals to stimulate the vagus nerve in the neck. The first step is to provide a rigid substrate, which can be prepared by injection molding, 3D printing, or other molding processes, and the necessary mounting grooves, through holes, and other structures can be machined on it according to design requirements. The second step is to provide the electrical stimulation unit, which includes assembling the pulse generating module, such as soldering components like chips onto a circuit board, connecting a battery, possibly pre-installing a protective shell or performing encapsulation, and preparing the electrodes. The third step is to perform final assembly, at least arranging the electrodes in predetermined positions on the rigid substrate and ensuring a reliable electrical connection between them and the circuit board of the pulse generating module. If an independent adhesive layer solution is used, the adhesive layer also needs to be adhered to the rigid base shell; if an assembly solution with a protective shell is used, the protective shell and the rigid base shell are finally assembled and closed. This method can be further refined according to the specific implementation of the product, such as electrode type, circuit integration level, etc.

[0067] Whether employing the metal electrodes and independent adhesive method of Embodiment 1 or the integrated conductive adhesive electrode of Embodiment 2, the vagus nerve stimulation device provided in this application has an overall flat box-like structure. By integrating the electrodes onto a rigid substrate, the device achieves high integration and miniaturization, making it highly portable and convenient for daily use. Moreover, the adhesive-based fixation method provides a stable and reliable wearing experience, ensuring the accuracy of the stimulation target during the user's daily activities, which is difficult to match with handheld or simple strap-on devices. The vagus nerve stimulation device provided in this application effectively solves the core pain points of traditional medical devices, such as bulkiness, inconvenience in wearing, and unstable fixation, providing users with a safe, convenient, comfortable, and potentially more effective new option for neuromodulation. During use, direct application stimulation is applied to the vagus nerve trunk in the neck. Compared to stimulating the ear branch, it can achieve a more direct and stronger neuromodulation effect with lower output energy, providing a new, user-friendly, non-invasive technical means for applications such as adjunctive treatment of depression, anxiety, and epilepsy, inflammation control, and promoting relaxation and sleep.

[0068] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A vagus nerve stimulation device, characterized by, include: An electrical stimulation unit includes a pulse generation module and electrodes electrically connected to the pulse generation module; A rigid substrate, at least for accommodating the electrodes thereon to support the electrodes; The rigid base shell is attached to the neck of the human body with adhesive so that the electrodes come into contact with the skin of the neck and output electrical stimulation signals to stimulate the vagus nerve in the neck.

2. The vagus nerve stimulation device of claim 1, wherein, The rigid substrate can be a metal part or a rigid plastic part.

3. The vagus nerve stimulation device of claim 1, wherein, The rigid substrate is provided with an electrode mounting groove, and the electrode is disposed in the electrode mounting groove.

4. The vagus nerve stimulation device of claim 1, wherein, The electrode is a metal electrode.

5. The vagus nerve stimulation device of claim 3, wherein, The vagus nerve stimulation device also includes an adhesive layer disposed on the rigid base shell for adhesion to the skin of the neck.

6. The vagus nerve stimulation device of claim 5, wherein, The rigid substrate is provided with an adhesive layer mounting groove, and the adhesive layer is disposed in the adhesive layer mounting groove.

7. The vagus nerve stimulation device of claim 6, wherein, Both the electrode mounting groove and the adhesive layer mounting groove are located on the side of the rigid base shell that contacts the human neck. There are two electrode mounting grooves, located at both ends of the rigid base shell, and the adhesive layer mounting groove is located between the two electrode mounting grooves.

8. The vagus nerve stimulation device of claim 1, wherein, The electrode is adhesive to adhere the rigid substrate to the skin of the neck.

9. The vagus nerve stimulation device of claim 8, wherein, The electrode is a conductive gel or a conductive double-sided adhesive.

10. The vagus nerve stimulation device of claim 8, wherein, A conductive reinforcement layer is also provided between the electrode and the rigid substrate, and the conductive reinforcement layer is electrically connected to the electrode.

11. The vagus nerve stimulation device of claim 10, wherein, The conductive reinforcement layer includes a graphite film or a metal film.

12. The vagus nerve stimulation device of claim 1, wherein, The pulse generation module includes a circuit board.

13. The vagus nerve stimulation device of claim 12, wherein, The rigid housing has an inner side facing the neck skin and an outer side facing away from the neck skin when in use. The electrode is located on the inner side of the rigid housing, and the circuit board is located on the outer side of the rigid housing. The two are electrically connected through a conductive portion passing through the rigid housing.

14. The vagus nerve stimulation device of claim 13, wherein, The conductive part is a wire or a conductive terminal.

15. The vagus nerve stimulation device of claim 12, wherein, The pulse generation module also includes a protective housing for protecting the circuit board.

16. The vagus nerve stimulation device of claim 15, wherein, The protective shell is assembled onto the rigid base shell to form a box structure, and the circuit board is located inside the box structure.

17. The vagus nerve stimulation device of claim 15, wherein, The protective shell is assembled on the outside of the circuit board to cover the circuit board, or the protective shell is formed on the outside of the circuit board by a sealing process to cover the circuit board.

18. The vagus nerve stimulation device of claim 15, wherein, The rigid base shell or protective shell is provided with control keys for triggering the circuit board to perform set functions. The control keys include one or more of the following: power on key, power off key, and stimulation intensity adjustment key. The control keys are in the form of one or more of the following: touch type, tactile touch type, and dial type.

19. The vagus nerve stimulation device of claim 15, wherein, The pulse generating module includes a battery, which is electrically connected to the circuit board. The battery is one or more of a disposable battery, a rechargeable battery, and a rechargeable capacitor.

20. The vagus nerve stimulation device of claim 19, wherein, The rigid base shell or protective shell is provided with a rechargeable interface, and the circuit board is electrically connected to the rechargeable interface; and / or, the circuit board is provided with a wireless charging coil.

21. The vagus nerve stimulation device of claim 1, wherein, The number of electrodes is even, and they are used to output stimulation signals to the skin of the neck and form a circuit.

22. A method of making a vagus nerve stimulation device, the method comprising: The preparation method is used to prepare the vagus nerve stimulation device as described in any one of claims 1 to 21, and the preparation method includes the following steps: S1. Provide a rigid base shell; S2. Provide an electrical stimulation unit, the electrical stimulation unit including a pulse generation module and electrodes electrically connected to the pulse generation module; S3. At least the electrodes are arranged on the rigid substrate so that when the rigid substrate is attached to the neck of a human body, the electrodes contact the skin of the neck and output electrical stimulation signals to stimulate the vagus nerve in the neck.

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