Neck vagus nerve stimulation device and preparation method thereof

Abstract

The invention relates to a neck vagus nerve stimulation device and a preparation method thereof. The neck vagus nerve stimulation device comprises a carrier sheet, an electrical stimulation generation module and a conductive adhesion part. The electrical stimulation generation module is used for generating electric pulses, and the conductive adhesion part is arranged on the carrier sheet and is electrically connected with the electrical stimulation generation module. Wherein the whole neck vagus nerve stimulation device is circular or approximately circular, and the conductive adhesion part is configured to be capable of adhering to the neck skin of the human body and serve as an electrode to stimulate the neck vagus nerve through the neck skin by means of the electric pulse generated by the electric stimulation generation module. Through the integrated design of the carrier sheet, the electrical stimulation generation module and the conductive adhesion part, the neck vagus nerve stimulation device is simplified into a light, thin and flexible patch which can be directly attached, and the portability, wearing comfort, use convenience and stimulation position stability of the device are greatly improved.

Description

Technical Field

[0001] This application relates to the field of neurostimulation device technology, and in particular to a cervical 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 weaker stimulation effects compared to direct stimulation of the cervical vagus nerve trunk. In contrast, directly stimulating the cervical vagus nerve trunk is more effective, but the development and commercial application of such products are relatively limited.

[0004] Existing cervical vagus nerve stimulation devices are often bulky and inconvenient to wear. They are mostly handheld or require straps for fixation, resulting in poor portability, the need for manual gripping 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 has high requirements for 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 cervical vagus nerve stimulation device that is highly integrated in structure, comfortable to wear, reliable in fixation, and easy to use, as well as a method for its preparation.

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

[0008] Carrier sheet;

[0009] An electrical stimulation generation module is used to generate electrical pulses;

[0010] A conductive adhesion portion is disposed on the carrier sheet and electrically connected to the electrical stimulation generating module;

[0011] The cervical vagus nerve stimulation device is generally circular or nearly circular, and the conductive adhesive part is configured to adhere to the skin of the human neck and act as an electrode to stimulate the cervical vagus nerve by transmitting the electrical pulses generated by the electrical stimulation generation module through the skin of the neck.

[0012] In some embodiments, the conductive adhesive portion is a conductive adhesive layer.

[0013] In some embodiments, the conductive adhesive layer is a conductive gel or a conductive double-sided adhesive.

[0014] In some embodiments, a conductive reinforcement layer is further provided between the conductive adhesion portion and the carrier sheet.

[0015] In some embodiments, the conductive enhancement layer comprises a graphite film.

[0016] In some embodiments, there are at least two conductive adhesive portions, and the two conductive adhesive portions are configured to be electrically isolated from each other on the carrier sheet.

[0017] In some embodiments, a space is provided between the two conductive adhesive portions, or an electrical insulating layer is provided between the two conductive adhesive portions.

[0018] In some embodiments, the carrier sheet is a flexible element that can deform to fit the skin of the neck.

[0019] In some embodiments, the carrier sheet is at least one of nonwoven fabric, medical fabric, or silicone.

[0020] In some embodiments, the electrical stimulation generating module includes a circuit board on which an electrical pulse generating circuit is arranged. The circuit board is a flexible circuit board, a rigid circuit board, or a semi-flexible circuit board and is embedded in the carrier sheet.

[0021] In some embodiments, the electrical stimulation generating module includes a circuit board that is mounted to the surface of the carrier sheet.

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

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

[0024] In some embodiments, the electrical stimulation generating module includes a circuit board that is separately disposed from the carrier sheet.

[0025] In some embodiments, the electrical stimulation generating module further includes a housing for protecting the circuit board.

[0026] In some embodiments, the housing is fitted onto the outside of the circuit board to cover the circuit board, or is formed on the outside of the circuit board by an encapsulation process to encapsulate the circuit board.

[0027] In some embodiments, the housing is provided with control buttons for triggering the circuit board to perform set functions. The control buttons include one or more of the following: a power button, a power off button, and a stimulation intensity adjustment button. The control buttons are in the form of one or more of the following: touch-sensitive, tactile, and dial-type.

[0028] In some embodiments, the electrical stimulation 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 rechargeable capacitor.

[0029] In some embodiments, the housing 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 carrier sheet is circular, the conductive adhesive portion is a pair, and each conductive adhesive portion is semi-circular.

[0031] In some embodiments, the carrier sheet has an embedding hole or groove, and the conductive adhesive portion is embedded in the embedding hole or groove.

[0032] In some embodiments, a peelable release film is provided on the conductive adhesive portion.

[0033] This application also adopts the following technical solution: a method for preparing a cervical vagus nerve stimulation device, the method being used to prepare the cervical vagus nerve stimulation device as described above, the method comprising the following steps:

[0034] S1. Provide carrier sheets;

[0035] S2, Provides an electrical stimulation generating unit for generating electrical pulses;

[0036] S3. A conductive adhesive part is provided on the carrier sheet and electrically connected to the electrical stimulation generating module. The conductive adhesive part can adhere to the skin of the human neck and act as an electrode to stimulate the vagus nerve of the neck through the skin of the neck with the electrical pulse generated by the electrical stimulation generating module.

[0037] The cervical vagus nerve stimulation device provided in this application is equipped with a carrier sheet. By integrating the electrode and adhesion function into a conductive adhesive part and placing it on the carrier sheet, the structure is simplified and a tight and stable contact between the electrode and the skin is ensured. The overall patch design allows users to use it at home or other places under the guidance of a doctor, which greatly improves the convenience and accessibility of treatment, while reducing the cost of use. Attached Figure Description

[0038] 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.

[0039] Figure 1 This is a perspective view of an embodiment of the cervical vagus nerve stimulation device of this application.

[0040] Figure 2 This is a perspective view of another embodiment of the cervical vagus nerve stimulation device of this application.

[0041] Figure 3 This is an exploded three-dimensional view of an embodiment of the cervical vagus nerve stimulation device of this application.

[0042] Figure 4 This is a schematic diagram of the encapsulation of the circuit board in one embodiment of the cervical vagus nerve stimulation device of this application.

[0043] Figure 5 This is a schematic diagram of the carrier sheet and the conductive adhesion portion in another embodiment of the cervical vagus nerve stimulation device of this application.

[0044] The components are labeled as follows: 101, outer casing; 102, circuit board; 103, battery; 104, carrier sheet; 105, conductive adhesive part; 106, spacer space; 107, embedding hole; 2, potting mold; 3, encapsulating material. Detailed Implementation

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] This application provides a vagus nerve stimulation device that can be directly adhered to the skin surface of the human neck. The device adopts a patch structure, integrating pulse generation, power supply, and adhesion functions into a thin and flexible whole, thereby solving the problems of poor portability, inconvenient wearing, and unstable fixation in existing cervical vagus nerve stimulation devices. The following detailed description, in conjunction with the accompanying drawings, illustrates specific embodiments.

[0051] Please see Figures 1 to 3As shown, this application provides a cervical vagus nerve stimulation device, which includes a carrier sheet 104, an electrical stimulation generating module, and a conductive adhesive part 105. The electrical stimulation generating module is used to generate electrical pulses, and the conductive adhesive part 105 is disposed on the carrier sheet 104 and electrically connected to the electrical stimulation generating module. The conductive adhesive part 105 is configured to adhere to the skin of the human neck and act as an electrode to stimulate the cervical vagus nerve through the skin of the neck using the electrical stimulation generating module.

[0052] The cervical vagus nerve stimulation device provided in this application includes a carrier patch 104. By integrating electrode and adhesion functions into a conductive adhesive part 105 disposed on the carrier patch 104, the structure is simplified, ensuring close and stable contact between the electrode and the skin. The overall patch design allows users to use it themselves at home or other locations under the guidance of a doctor, greatly improving the convenience and accessibility of treatment while reducing usage costs.

[0053] Please see Figure 1 and Figure 3 As shown, the carrier sheet 104 serves as the supporting base of the cervical vagus nerve stimulation device. The carrier sheet 104 can be a flexible component, capable of deformation to conform to the neck skin, and its material possesses certain softness, biocompatibility, and appropriate mechanical strength. In this embodiment, the carrier sheet is preferably made of non-woven fabric. Non-woven fabric has advantages such as low cost, good breathability, softness, flexibility, and ease of processing, and can well adapt to the curvature and movement of the neck skin. It is understood that in other embodiments, the carrier sheet 104 can also be made of other materials with similar properties, such as medical cotton cloth or other medical flexible textiles or silicone, as long as it can provide stable support for the electrical stimulation generation module and the conductive adhesion part 105 and ensure wearing comfort. In this embodiment, the cervical vagus nerve stimulation device is circular or nearly circular in shape, and the carrier sheet 104 is also circular or nearly circular. The carrier sheet 104 serves as the supporting base of the entire device, and its shape determines the overall shape of the device. Circular or near-circular structures have a large surface area, which facilitates uniform coverage around the stimulation target and makes them easy to use; moreover, the smooth edges of a circle provide a comfortable fit against the skin. Near-circular shapes can include ellipses with similar major and minor axes, pentagons, hexagons, or polygons with more sides, as well as other shapes with curved edges and relatively uniform radial dimensions.

[0054] Please see Figure 3As shown, the electrical stimulation generation module is the core functional component of this cervical vagus nerve stimulation device, used to generate electrical pulse signals for stimulating the vagus nerve. The electrical stimulation generation module includes a pulse generation circuit, which is responsible for generating electrical pulses with specific parameters, such as specific frequency, pulse width, and current / voltage intensity. It is typically composed of integrated circuit chips, resistors, capacitors, inductors, and other electronic components arranged on a circuit board 102. That is, the electrical stimulation generation module includes a circuit board 102, on which the pulse generation circuit is arranged. In this embodiment, the circuit board 102 is also disposed on the carrier sheet 104. The circuit board 102 can be fixed to the carrier sheet 104 by, but is not limited to, bonding with medical-grade adhesives, or mechanical methods such as riveting or sewing.

[0055] The arrangement of the circuit board 102 and the carrier sheet 104 can be varied. In some embodiments, the circuit board 102 can be a flexible printed circuit (FPC), a rigid circuit board, or a semi-flexible circuit board, and is embedded within the carrier sheet 104. Specifically, the carrier sheet 104 can have a multi-layer structure with a receiving space within it, and the circuit board 102 is fixed within the receiving space. This embedded installation method allows the carrier sheet 104 to protect the circuit board 102 and makes the entire device look simple and aesthetically pleasing. The circuit board 102, being a flexible circuit board, combined with the flexible carrier sheet 104, can achieve better fit with the neck skin. The circuit board 102 can also be a semi-flexible circuit board, i.e., a rigid-flex board, which integrates the stability of a rigid circuit board and the flexibility of a flexible circuit board into a high-performance hybrid circuit board. Of course, the circuit board 102 can also be a rigid circuit board, i.e., a traditional rigid circuit board, with its size limited to reduce its impact on the tightness of the fit with the neck.

[0056] In other embodiments, the circuit board 102 is mounted to the surface of the carrier sheet 104. More specifically, the carrier sheet 104 has an inner surface facing the neck skin and an outer surface facing away from the neck skin during use. The conductive adhesive portion 105 is located on the inner surface of the carrier sheet 104, and the circuit board 102 is located on the outer surface of the carrier sheet 104, and the two are electrically connected through a conductive portion passing through the carrier sheet 104. In this embodiment, the circuit board 102 and the conductive adhesive portion 105 are positioned on opposite sides of the carrier sheet 104, making it more flat and comfortable when attached to the neck, reducing the feeling of foreign objects. To achieve the electrical connection, the circuit board 102 and the conductive adhesive portion 105 are electrically connected through a conductive portion passing through the carrier sheet 104. The conductive portion can be a flexible wire, one end of which is soldered or crimped onto the output pad of the circuit board 102, and the other end is connected to the conductive adhesive portion 105. The conductive part can also be a rigid conductive terminal, with one end inserted into the conductive hole or connector of the circuit board 102, and the other end passing through the carrier sheet 104 and connecting to the conductive adhesion part 105. This layout cleverly utilizes the thickness space of the carrier sheet 104 to achieve separation of the circuit part from the skin contact part, which is beneficial to optimizing the overall structure.

[0057] In other embodiments, the circuit board 102 and the carrier sheet 104 are separately disposed. Specifically, the conductive adhesive portion 105 is connected to the inner surface of the carrier sheet 104, and there is no relatively fixed relationship between the circuit board 102 and the carrier sheet 104. The circuit board 102 can be electrically connected to the conductive adhesive portion 105 via a long wire, so that the circuit board 102 can be detached from the carrier sheet 104 and extended to a position convenient for user operation. For example, in use, the circuit board 102 can be rested on the user's shoulder, held by the user's hand, or placed in the user's clothing pocket.

[0058] like Figure 1 and Figure 3As shown, to provide physical protection for delicate electronic components, especially the circuit board 102 and its components, and to prevent them from being affected by external impacts, moisture, or abrasion, the electrical stimulation generating module further includes a housing 101. Specifically, the electrical stimulation generating module includes a housing 101 disposed outside the circuit board 102. The specific position of the housing 101 depends on the position of the circuit board 102; it may be disposed on the carrier sheet 104 or detached from the carrier sheet 104. The housing 101 may be made of a lightweight, insulating material such as medical plastic. In some embodiments, the housing 101 is fitted onto the outside of the circuit board 102 to cover the circuit board 102; in other embodiments, the housing 101 is formed on the outside of the circuit board 102 by a sealing process to encapsulate the circuit board 102. Specifically, the outer casing 101 can take two main forms: one is as an independent prefabricated component, assembled to the outside of the circuit board 102 by means of clips, screws, adhesives, etc., and further, it can be fixed to the carrier sheet 104 by means of sewing, riveting, adhesives, etc.; the other is through a sealing process, such as... Figure 4 As shown, the circuit board 102 is placed in the potting mold 2, and liquid encapsulating material 3, such as epoxy resin or silicone, is poured into the potting mold 2 to flow evenly above, below, and around the circuit board 102. After curing, a protective outer shell 101 is formed. The encapsulation process can better achieve the integrity and sealing of the structure, and is especially beneficial for improving the waterproof and moisture-proof performance of the device. The presence of the outer shell 101 ensures the reliability and durability of the internal circuitry in complex operating environments.

[0059] The outer casing 101 is provided with control buttons for triggering the circuit board 102 to execute set functions. These control buttons include one or more of a power-on button, a power-off button, and a stimulation intensity adjustment button. The control buttons can be touch-sensitive, tactile, or DIP-type. These control buttons are used to control the basic functions of the device, such as powering on / off and adjusting the intensity of electrical stimulation. The specific form of the control buttons can be varied to meet the requirements of a thin and lightweight patch device. 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. These control buttons allow users to flexibly adjust stimulation parameters according to their own feelings and needs without relying on external devices. Furthermore, the electrical stimulation generating module includes a battery 103, which can be one or more of a disposable battery, a rechargeable battery, or a rechargeable capacitor. The battery 103 is rechargeable, with a rechargeable interface on the housing 101, and the circuit board 102 electrically connected to the rechargeable interface; and / or, a wireless charging coil is provided on the circuit board 102. Specifically, the battery 103 provides operating power for the entire electrical stimulation generation module, especially the pulse generation circuit. The battery 103 can be soldered or mounted / connected to the circuit board 102 via connectors. Depending on the product's intended use, the battery 103 can have various options. For applications prioritizing convenience and hygiene, disposable batteries, such as disposable silver-zinc batteries, can be used; these have high energy density, small size, and are suitable for single-use products. For applications emphasizing environmental protection and long-term cost control, rechargeable batteries, such as lithium polymer batteries, or charging capacitors can be used. If a rechargeable solution is adopted, a wireless charging coil or a rechargeable interface can be further integrated into the circuit board 102 for easy recharging. The wireless charging coil enables contactless charging, further improving the device's sealing and ease of use; the rechargeable interface is used for charging via a charging cable, and the rechargeable interface can be, for example, a magnetic adsorption interface, a Micro-USB interface, or a Type-C interface. The selection and configuration of the battery 103 provides flexibility for the product to be used only once or repeatedly.

[0060] like Figure 1 As shown, in this embodiment, the circuit board 102 and its outer casing 101 are located on one side of the carrier sheet 104; as Figure 2 and Figure 3As shown, the conductive adhesive portion 105 is located on the other side of the carrier sheet 104. Specifically, the carrier sheet 104 has an inner surface facing the neck skin and an outer surface facing away from the neck skin during use, and the conductive adhesive portion 105 is attached to the inner surface of the carrier sheet 104. The conductive adhesive portion 105 serves two functions: as an electrode and as an adhesive layer. Firstly, the conductive adhesive portion 105 uses its adhesiveness to firmly attach the entire device to the target skin area of ​​the user's neck; secondly, it acts as an electrode to efficiently and with low loss transmit the electrical pulses generated by the electrical stimulation module to the subcutaneous layer of the skin, acting on the vagus nerve. Specifically, the conductive adhesive portion 105 serves as the output terminal of the electrical pulse, and there are two or an even number of them to form a complete current loop. In this embodiment, the carrier sheet 104 is circular, and the conductive adhesive portions 105 are a pair, with each conductive adhesive portion being semi-circular. Two semi-circular conductive adhesive portions 105 can fully utilize the area of ​​the carrier sheet 104, providing a larger coverage area, thereby effectively covering the target stimulation area and facilitating the formation of a uniformly distributed stimulation electric field. The conductive adhesive portions 105 can be made of biocompatible materials. The conductive adhesive portions 105 can be disposed on the carrier sheet 104 by direct coating, molding, or pre-forming and then attaching to the carrier sheet 104. In some embodiments, such as... Figure 5As shown, the carrier sheet 104 has an embedding hole 107 or a groove, and the conductive adhesive part 105 is embedded in the embedding hole 107 or groove. For this embedding method, the surface of the conductive adhesive part 105 can be set flush with the inner surface of the carrier sheet 104. Preferably, the conductive adhesive part 105 is set to slightly protrude from the inner surface of the carrier sheet 104 to ensure that the conductive adhesive part 105 can fit tightly against the neck skin during use. The conductive adhesive part 105 is a conductive adhesive layer, specifically, for example, conductive gel or conductive double-sided tape. Conductive gel has excellent biocompatibility, conductivity, and moderate adhesion, ensuring low-resistance contact with the skin while providing a comfortable wearing experience. Conductive double-sided tape can adhere to the carrier sheet 104 and can be removed and replaced when its adhesiveness or conductivity decreases after one or more uses. In this embodiment, the arrangement of the circuit board 102 and the conductive adhesive portion 105 on opposite sides of the carrier sheet 104 helps reduce the overall thickness of the device, making it more flat and comfortable when attached to the neck, reducing the feeling of foreign objects. For electrical connection, the circuit board 102 and the conductive adhesive portion 105 are electrically connected via an electrical connection portion passing through the carrier sheet 104. This electrical connection portion can be a flexible wire, with one end soldered or crimped to the output pad of the circuit board 102 and the other end connected to the conductive adhesive portion 105. Alternatively, the electrical connection portion can be a rigid conductive terminal, with one end inserted into a conductive hole or connector of the circuit board 102 and the other end passing through the carrier sheet 104 and connecting to the conductive adhesive portion 105. This layout cleverly utilizes the thickness of the carrier sheet 104, achieving separation of the circuitry from the skin contact portion, which is beneficial for optimizing the overall structure.

[0061] Furthermore, a conductive reinforcement layer is also provided between the conductive adhesion portion and the carrier sheet 104. In some embodiments, the conductive reinforcement layer includes a graphite film. Specifically, to further improve conductivity, a conductive reinforcement layer, such as a graphite film, can be provided between the conductive adhesion portion 105 and the carrier sheet 104. The graphite film can enhance conductivity and effectively diffuse current laterally, making the current distribution more uniform, avoiding edge effects and local hot spots, and improving the safety and effectiveness of stimulation.

[0062] Please see Figure 2As shown, there are at least two conductive adhesive portions 105, and these two conductive adhesive portions 105 are configured to be electrically isolated from each other on the carrier sheet 104. In this embodiment, a space 106 is provided between the two conductive adhesive portions 105 to achieve electrical isolation; in other embodiments, an electrically insulating layer may be provided between the two conductive adhesive portions 105 to achieve electrical isolation. The number of conductive adhesive portions 105 is at least two, forming a pair of positive and negative electrodes. These two conductive adhesive portions 105 must be electrically isolated to ensure that the current flows through the target tissue depth. This embodiment achieves this by designing a sufficient space 106 between them. The space 106 between the two conductive adhesive portions 105 ensures that the current mainly flows through the tissue path under the skin, forming an effective stimulation circuit and avoiding short circuits of the current on the skin surface. In other embodiments, to ensure insulation reliability in a compact layout, an electrically insulating material, such as a plastic spacer or insulating adhesive, can be embedded between the two as an electrically insulating layer. The electrically insulating layer is provided between the two conductive adhesion portions 105 to physically block the direct surface pathway of the current, further ensuring stimulation depth and efficiency.

[0063] Furthermore, the conductive adhesive part 105 is provided with a peelable release film (not shown in the figure). In use, the release film is peeled off and the conductive adhesive part 105 is attached to the skin of the neck. After use, the cervical vagus nerve stimulation device is removed and the release film is reattached to the conductive adhesive part 105 to protect the conductive adhesive part 105 and prevent it from adhering to dust and other debris or losing its adhesiveness and reducing its conductivity due to long-term exposure to air.

[0064] The cervical vagus nerve stimulation device provided in this application can be manufactured by the following method: S1, providing a carrier sheet 104; S2, providing an electrical stimulation generating unit for generating electrical pulses; S3, providing a conductive adhesive part 105, disposed on the carrier sheet 104 and electrically connected to the electrical stimulation generating module. The conductive adhesive part 105 can adhere to the skin of the human neck and, as an electrode, stimulate the cervical vagus nerve through the skin of the neck with the electrical pulses generated by the electrical stimulation generating module. The above manufacturing method includes the steps described above, but does not limit the order of the steps. Furthermore, the circuit board 102 and the housing 101 included in the electrical stimulation generating module can be assembled, connected, or formed according to different specific implementation methods.

[0065] The usage process of the cervical vagus nerve stimulation device provided in this application is briefly described as follows. First, the user determines the approximate stimulation location of the cervical vagus nerve according to the instructions attached to the device. Then, the user peels off the release film protecting the conductive adhesive part 105, aligns the device with the target area, attaches the conductive adhesive part 105 to the neck skin, and gently presses to ensure full contact between the conductive adhesive part 105 and the skin. Next, the user turns on the device using the control button and adjusts the stimulation intensity to a suitable level according to personal tolerance. The device then outputs electrical pulses according to a preset or selected program, stimulating the cervical vagus nerve through the conductive adhesive part 105. After use, the user turns off the device and gently peels it off the skin, and the release film can be reattached to the conductive adhesive part 105. The cervical vagus nerve stimulation device provided in this application can be a disposable product or a reusable product. When it is a disposable product, it should be disposed of as medical waste after use. When it is a reusable product, the battery can be replaced or recharged when the device's power is low for future use.

[0066] As described above in the specific embodiments, the cervical vagus nerve stimulation device provided in this application includes a carrier sheet 104. By integrating the electrodes and adhesion function into a conductive adhesive part 105 disposed on the carrier sheet 104, the structure is simplified, ensuring close and stable contact between the electrodes and the skin. The use of the carrier sheet 104 allows the device to perfectly conform to the curve of the neck, making it comfortable to wear. The integrated patch design allows users to use it themselves at home or in other places under the guidance of a doctor, greatly improving the convenience and accessibility of treatment, while reducing the cost of use. Through the integrated design of the carrier sheet 104, the electrical stimulation generation module, and the conductive adhesive part 105, this application simplifies the cervical vagus nerve stimulation device into a thin, flexible, and directly attachable patch, greatly improving the portability, wearing comfort, ease of use, and stability of the stimulation position, effectively overcoming the shortcomings of the prior art.

[0067] 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 cervical vagus nerve stimulation device, characterized in that, include: Carrier sheet; An electrical stimulation generation module is used to generate electrical pulses; A conductive adhesion portion is disposed on the carrier sheet and electrically connected to the electrical stimulation generating module; The cervical vagus nerve stimulation device is generally circular or nearly circular, and the conductive adhesive part is configured to adhere to the skin of the human neck and act as an electrode to stimulate the cervical vagus nerve by transmitting the electrical pulses generated by the electrical stimulation generation module through the skin of the neck.

2. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The conductive adhesive portion is a conductive adhesive layer.

3. The cervical vagus nerve stimulation device according to claim 2, characterized in that, The conductive adhesive layer is a conductive gel or a conductive double-sided adhesive.

4. The cervical vagus nerve stimulation device according to claim 1, characterized in that, A conductive reinforcement layer is also provided between the conductive adhesion part and the carrier sheet.

5. The cervical vagus nerve stimulation device according to claim 4, characterized in that, The conductive reinforcement layer includes a graphite film.

6. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The conductive adhesive portion is at least two, and the two conductive adhesive portions are configured to be electrically isolated from each other on the carrier sheet.

7. The cervical vagus nerve stimulation device according to claim 6, characterized in that, A space is provided between the two conductive adhesive portions, or an electrical insulating layer is provided between the two conductive adhesive portions.

8. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The carrier sheet is a flexible component that can deform to fit the skin of the neck.

9. The cervical vagus nerve stimulation device according to claim 8, characterized in that, The carrier sheet is at least one of non-woven fabric, medical fabric, or silicone.

10. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The electrical stimulation generating module includes a circuit board on which an electrical pulse generating circuit is arranged. The circuit board is a flexible circuit board, a rigid circuit board, or a semi-flexible circuit board and is embedded in the carrier sheet.

11. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The electrical stimulation generating module includes a circuit board, which is mounted on the surface of the carrier sheet.

12. The cervical vagus nerve stimulation device according to claim 11, characterized in that, The carrier sheet has an inner side facing the neck skin and an outer side facing away from the neck skin when in use. The conductive adhesive portion is located on the inner side of the carrier sheet, and the circuit board is located on the outer side of the carrier sheet. The two are electrically connected through a conductive portion passing through the carrier sheet.

13. The cervical vagus nerve stimulation device according to claim 12, characterized in that, The conductive part is a wire or a conductive terminal.

14. The cervical vagus nerve stimulation device according to claim 1, characterized in that, The electrical stimulation generating module includes a circuit board, which is separately disposed from the carrier sheet.

15. The cervical vagus nerve stimulation device according to any one of claims 11 to 14, characterized in that, The electrical stimulation generating module also includes a housing for protecting the circuit board.

16. The cervical vagus nerve stimulation device according to claim 15, characterized in that, The housing is fitted onto the outside of the circuit board to cover the circuit board, or is formed on the outside of the circuit board by a sealing process to encapsulate the circuit board.

17. The cervical vagus nerve stimulation device according to claim 15, characterized in that, The outer casing is provided with control buttons for triggering the circuit board to perform set functions. The control buttons include one or more of the following: power on button, power off button, and stimulation intensity adjustment button. The control buttons are in the form of one or more of the following: touch type, tactile touch type, and dial type.

18. The cervical vagus nerve stimulation device according to claim 15, characterized in that, The electrical stimulation 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.

19. The cervical vagus nerve stimulation device according to claim 18, characterized in that, The outer casing 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.

20. The cervical vagus nerve stimulation device according to any one of claims 1 to 14, characterized in that, The carrier sheet is circular, and the conductive adhesive portion is a pair, with each conductive adhesive portion being semi-circular.

21. The cervical vagus nerve stimulation device according to any one of claims 1 to 14, characterized in that, The carrier sheet has an embedding hole or groove, and the conductive adhesive part is embedded in the embedding hole or groove.

22. The cervical vagus nerve stimulation device according to any one of claims 1 to 14, characterized in that, A peelable release film is provided on the conductive adhesion part.

23. A method for preparing a cervical vagus nerve stimulation device, characterized in that, The preparation method is used to prepare the cervical vagus nerve stimulation device as described in any one of claims 1 to 22, and the preparation method includes the following steps: S1. Provide carrier sheets; S2, Provides an electrical stimulation generating unit for generating electrical pulses; S3. A conductive adhesive part is provided on the carrier sheet and electrically connected to the electrical stimulation generating module. The conductive adhesive part can adhere to the skin of the human neck and act as an electrode to stimulate the vagus nerve of the neck through the skin of the neck with the electrical pulse generated by the electrical stimulation generating module.

Images