Vagus nerve stimulation device and preparation method thereof

Abstract

The invention provides vagus nerve stimulation equipment and a preparation method thereof, and the equipment can enable a flexible patch to be well attached to the curved surface of the neck of a human body through the bias design of an electrode, thereby improving the wearing comfort of a user, and improving the electric pulse stimulation effect of vagus nerves. The vagus nerve stimulation equipment comprises a control panel for generating pulse current, a connecting piece which is electrically connected with the control panel and extends outwards from the control panel, and at least one pair of electrodes which are arranged on the connecting piece at intervals and are electrically connected with the connecting piece, wherein the connecting piece has a flexible structure; the patch assembly comprises at least one pair of conductive adhesive layers which are arranged on the connecting piece and can be correspondingly and electrically connected with the electrodes; the control board is used for generating a stimulation signal to be transmitted to the vagus nerve through the connecting piece, the electrode and the conductive adhesive layer.

Description

Technical Field

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

[0002] The vagus nerve, a mixed nerve, has motor fibers that run parallel to the glossopharyngeal nerve, exiting the brainstem and exiting the cranial cavity through the jugular foramen. The vagus nerve branches out into the neck, chest, and abdomen, innervating organs in the neck and chest cavity, as well as most organs in the abdominal cavity. It regulates the circulatory, respiratory, and digestive systems by transmitting sensory impulses from organs and controlling the activity of cardiac, smooth muscle, and glandular tissues.

[0003] Currently, vagus nerve stimulation is an advanced neuromodulation technique that uses electrical pulses to stimulate the vagus nerve in the neck, thereby regulating brain function and providing new treatment options for a variety of intractable diseases.

[0004] However, as the core component of a neurostimulator, the electrode patch is usually a flexible patch directly attached to the electrode box to make contact with the electrodes extending from the electrode box to achieve electrical connection. This results in the flexible patch being restricted in deformation under the influence of the electrode box, and it cannot conform well to the curved surface of the human neck. This reduces the user's wearing comfort and also results in poor electrical pulse stimulation effect on the vagus nerve. Summary of the Invention

[0005] To address the problem that the flexible patch in existing neurostimulators is limited in deformation due to the electrode box, thus failing to conform well to the curved surface of the human neck, this application provides a vagus nerve stimulation device and its preparation method. Through electrode bias design, the flexible patch can conform well to the curved surface of the human neck, thereby improving user comfort and enhancing the electrical pulse stimulation effect of the vagus nerve.

[0006] According to one aspect of this application, one embodiment provides a vagus nerve stimulation device, comprising: an electrode assembly including a control board for generating pulsed current, a connector electrically connected to and extending outward from the control board, and at least a pair of electrodes spaced apart from and electrically connected to the connector; wherein the connector has a flexible structure; and a patch assembly including at least a pair of conductive adhesive layers disposed on the connector and capable of being electrically connected to the electrodes correspondingly; the control board is used to generate stimulation signals to be transmitted to the vagus nerve through the connector, the electrodes, and the conductive adhesive layers.

[0007] According to some embodiments of this application, the control board includes a rigid circuit board on which a microprocessor and pulse generation circuit are disposed; the connector includes a flexible circuit board electrically connected to the control board and the electrodes.

[0008] According to some embodiments of this application, the flexible circuit board has a fixed end that is fixedly connected to the control board and a free end that is disposed away from the control board.

[0009] According to some embodiments of this application, the flexible circuit board includes a flexible plate extending from the fixed end to the free end and fixedly connected to the electrode, and at least one pair of connection circuits disposed on the flexible plate and electrically connecting the electrode to the control board.

[0010] According to some embodiments of this application, two electrodes in each pair of electrodes are arranged at intervals along the length of the flexible circuit board on the flexible plate.

[0011] According to some embodiments of this application, the length direction of the flexible circuit board is the same as the extension direction of the flexible plate.

[0012] According to some embodiments of this application, the two connection circuits in each pair of connection circuits are respectively located on opposite sides of the line connecting the two electrodes connected to each pair of connection circuits.

[0013] According to some embodiments of this application, one electrode in each pair of electrodes is arranged adjacent to the fixed end, and the other electrode in each pair of electrodes is arranged adjacent to the free end.

[0014] According to some embodiments of this application, the patch assembly further includes a flexible carrier sheet stacked between the connector and the conductive adhesive layer; the flexible carrier sheet is provided with a conductive window capable of being electrically connected to the electrode and the conductive adhesive layer.

[0015] According to some embodiments of this application, the flexible substrate is disposed on the flexible circuit board for a first surface facing human skin.

[0016] According to some embodiments of this application, one end of the flexible carrier extends to the side surface of the control panel facing human skin.

[0017] According to some embodiments of this application, the flexible carrier is selected from nonwoven fabric layers, medical fabrics, silicone, or flexible polymer films.

[0018] According to some embodiments of this application, the electrode protrudes from the first surface of the flexible circuit board; the conductive window is a clearance hole that penetrates the flexible substrate and allows the electrode to pass through.

[0019] According to some embodiments of this application, the electrode is embedded or protrudes from the first surface of the flexible circuit board; the conductive window is a conductive contact embedded in the flexible substrate and electrically connected to the conductive adhesive layer.

[0020] According to some embodiments of this application, the vagus nerve stimulation device further includes a flexible covering layer covering the connector.

[0021] According to some embodiments of this application, the flexible overlay is disposed on a second surface of the flexible circuit board facing away from human skin.

[0022] According to some embodiments of this application, the flexible overlay is detachably connected to the flexible carrier.

[0023] According to some embodiments of this application, the electrode assembly further includes a housing that is detachably mounted on the control panel on the side facing away from human skin.

[0024] According to some embodiments of this application, the electrode assembly further includes a power supply module disposed in the housing and electrically connected to the control board.

[0025] According to some embodiments of this application, the power supply module includes a built-in power supply disposed within the housing and electrically connected to the control board, and / or a power supply interface disposed within the housing and electrically connected to the control board.

[0026] According to some embodiments of this application, the conductive adhesive layer includes a conductive gel for adhering to the skin surface.

[0027] According to some embodiments of this application, the connector includes at least one pair of wires that electrically connect the electrode to the control board.

[0028] According to another aspect of this application, one embodiment of this application further provides a method for preparing a vagus nerve stimulation device, comprising the steps of: At least one pair of electrodes are arranged at intervals on a connector that is electrically connected to and extends outward from the control board, wherein the connector has a flexible structure; and at least one pair of conductive adhesive layers are disposed on the connector to be electrically connected to the electrodes.

[0029] In summary, because the electrodes in the electrode assembly are arranged on the connectors extending outward from the control board, the electrodes are biased relative to the control board. Therefore, the conductive adhesive layer on the connectors in the patch assembly will also be offset from the control board and will not be deformed or restricted by the control board. This allows the patch assembly to conform well to the curved surface of the human neck, thereby improving user comfort and enhancing the electrical pulse stimulation effect on the vagus nerve.

[0030] Furthermore, when a user wears the vagus nerve stimulation device, simply bending the flexible connector ensures that the patch assembly conforms well to the curve of the human neck, while the control board does not need to be bent or deformed. This also completely avoids the microprocessor and pulse generation circuit on the control board becoming loose or damaged due to deformation, which helps to extend the overall service life of the vagus nerve stimulation device. Attached Figure Description

[0031] 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.

[0032] Figure 1 A three-dimensional schematic diagram of a vagus nerve stimulation device provided in one embodiment of this application; Figure 2 An exploded schematic diagram of a vagus nerve stimulation device according to the above embodiments of this application is shown; Figure 3 A schematic diagram of the connector and control board in the vagus nerve stimulation device according to the above embodiments of this application is shown; Figure 4 A cross-sectional schematic diagram of a vagus nerve stimulation device according to the above embodiments of this application is shown; Figure 5 A modified example of the vagus nerve stimulation device according to the above embodiments of this application is shown; Figure 6 This is a schematic flowchart illustrating a method for preparing a vagus nerve stimulation device according to an embodiment of this application.

[0033] Figure label: 10. Electrode assembly; 11. Housing; 12. Control board; 13. Connector; 130. Flexible circuit board; 1301. Fixed end; 1302. Free end; 1303. First surface; 1304. Second surface; 131. Flexible board; 132. Connecting circuit; 1321. Parallel line segment; 1322. Inclined line segment; 14. Electrode; 15. Power supply module; 151. Built-in power supply; 152. Power supply interface; 20. Patch assembly; 21. Conductive adhesive layer; 22. Flexible carrier; 220. Conductive window; 2201. Clearance hole; 2202. Conductive contact; 30. Flexible covering layer. Detailed Implementation

[0034] 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.

[0035] 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.

[0036] 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 feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0037] 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.

[0038] 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.

[0039] Considering that the flexible patches in existing neurostimulators are limited in deformation due to the influence of the electrode box, they cannot conform well to the curved surface of the human neck, which reduces user comfort and results in poor electrical pulse stimulation of the vagus nerve. To solve this problem, this application provides a vagus nerve stimulation device and its preparation method, which, through electrode bias design, allows the patch to conform well to the curved surface of the human neck, thereby improving user comfort while enhancing the electrical pulse stimulation effect of the vagus nerve.

[0040] Specifically, please refer to Figures 1 to 5 One embodiment of this application provides a vagus nerve stimulation device, which may include an electrode assembly 10 and a patch assembly 20. The electrode assembly 10 includes a control board 12 for generating pulsed currents, a connector 13 electrically connected to and extending outward from the control board 12, and at least a pair of electrodes 14 spaced apart from and electrically connected to the connector 13. The connector 13 has a flexible structure. The patch assembly 20 includes at least a pair of conductive adhesive layers 21 disposed on the connector 13 and capable of correspondingly electrically connecting to the electrodes 14. The control board 12 generates stimulation signals to be transmitted to the vagus nerve via the connector 13, the electrodes 14, and the conductive adhesive layers 21.

[0041] Thus, when the conductive adhesive layer 21 in the vagus nerve stimulation device is attached to human skin, at least one pair of electrodes 14 can directly or indirectly contact the corresponding conductive adhesive layer 21 to achieve electrical connection between the electrode 14 and the conductive adhesive layer 21. At this time, the control board 12 can control the output of pulse current from at least one pair of electrodes 14 through the connector 13 to conduct the pulse current to human skin through at least one pair of conductive adhesive layers 21, forming a closed pulse circuit, thereby stimulating the vagus nerve of the human body through electrical pulses.

[0042] It is worth noting that, such as Figure 1 and Figure 4 As shown, since the electrode 14 in the electrode assembly 10 is arranged on the connector 13 extending outward from the control plate 12, the electrode 14 is biased relative to the control plate 12. Therefore, the conductive adhesive layer 21 disposed on the connector 13 in the patch assembly 20 will also be offset from the control plate 12 as a whole and will not be deformed or restricted under the influence of the control plate 12. This allows the patch assembly 20 to conform well to the curved surface of the human neck, so as to improve the user's wearing comfort and enhance the electrical pulse stimulation effect of the vagus nerve.

[0043] Furthermore, when a user wears the vagus nerve stimulation device, simply bending the flexible connector 13 ensures that the patch assembly 20 conforms well to the curved surface of the human neck, while the control board 12 does not need to be bent or deformed. This also completely avoids the microprocessor and pulse generation circuit on the control board 12 becoming loose or damaged due to deformation, which helps to extend the overall service life of the vagus nerve stimulation device.

[0044] More specifically, the control board 12 may include, but is not limited to, a rigid circuit board, such as a PCB board, on which a microprocessor and pulse generation circuit are arranged, for controlling the power on / off of the device, mode switching, and adjustment of the frequency and intensity of the output pulse signal, etc. It is understood that in other embodiments of this application, the control board 12 mentioned in this application may also be implemented as a composite circuit board, as long as it can realize the generation of pulse signals, which will not be elaborated further in this application.

[0045] It should be noted that the flexible structure of the connector 13 mentioned in this application may refer to the connector 13 having an overall flexible structure, a semi-flexible structure, or a partially flexible structure.

[0046] Optionally, such as Figures 2 to 4 As shown, the connector 13 mentioned in this application is implemented as a flexible circuit board 130 electrically connected to the control board 12 and the electrode 14, so that by means of the excellent flexibility and bendability of the flexible circuit board 130 itself, it can transmit pulse current between the control board 12 and the electrode 14 while conforming well to the curved surface of the human neck.

[0047] Optionally, such as Figures 2 to 4 As shown, one end of the flexible circuit board 130 is fixedly connected to the control board 12, so that the flexible circuit board 130 can be reliably electrically connected to the rigid circuit board to serve as a carrier for signal extension transmission.

[0048] For example, such as Figure 2 and Figure 3 As shown, the flexible circuit board 130 has a fixed end 1301 that is fixedly connected to the control board 12 and a free end 1302 that is arranged away from the control board 12, so that the user can wrap the flexible circuit board 130 around the user's neck.

[0049] Optionally, such as Figures 1 to 5 As shown, the electrode assembly 10 also includes a housing 11, and the control board 12 is disposed on the housing 11 so that the free end 1302 of the flexible circuit board 130 is located outside the housing 11.

[0050] Optionally, such as Figure 2 and Figure 3As shown, the flexible circuit board 130 includes a flexible plate body 131 extending from the fixed end 1301 to the free end 1302 and fixedly connected to the electrode 14, and at least one pair of connection circuits 132 disposed on the flexible plate body 131 and electrically connected to the electrode 14 and the control board 12, so as to electrically connect the electrode 14 to the control board 12 while carrying the electrode 14.

[0051] Optionally, such as Figure 2 and Figure 3 As shown, the two electrodes 14 in each pair of electrodes 14 are arranged at intervals along the length of the flexible circuit board 130 on the flexible board 131, so that the two conductive adhesive layers 21 in each pair of conductive adhesive layers 21 can be arranged at intervals along the length of the flexible circuit board 130. This ensures that when the flexible circuit board 130 is wrapped around the neck of a human, the two conductive adhesive layers 21 in each pair can be arranged circumferentially along the neck of the human to accurately fit the vagus nerve sites on both sides of the neck, so as to serve as pulse output terminals that directly contact the skin of the human body, forming a closed pulse circuit.

[0052] Preferably, such as Figure 2 and Figure 3 As shown, the length direction of the flexible circuit board 130 mentioned in this application is the same as the extension direction of the flexible plate 131, such that the control board 12 and the outer shell 11 are located on the short side of the flexible circuit board 130, ensuring that the majority of the flexible circuit board 130 is located outside the outer shell 11, so as to better conform to the curved surface of the human neck. It is understood that in other examples of this application, the length direction of the flexible circuit board 130 may be different from the extension direction of the flexible plate 131, such as the control board 12 and the outer shell 11 being located on the long side of the flexible circuit board 130, which will not be elaborated further in this application.

[0053] Optionally, such as Figure 2 and Figure 3 As shown, one electrode 14 in each pair of electrodes 14 is arranged adjacent to the fixed end 1301, and the other electrode 14 in each pair of electrodes 14 is arranged adjacent to the free end 1302, so as to maximize the spacing between the two electrodes 14 while ensuring that the deformation of the conductive adhesive layer 21 is not affected, thus meeting the stimulation needs of the human neck.

[0054] Optionally, such as Figure 2 and Figure 3 As shown, the two connection circuits 132 in each pair of connection circuits 132 are located on opposite sides of the line connecting the two electrodes 14 connected to each pair of connection circuits 132, so as to maximize the spacing between the two connection circuits 132, which can not only reduce the wiring difficulty, but also reduce the risk of electromagnetic interference.

[0055] Preferably, such as Figure 2 and Figure 3 As shown, the connection circuit 132 has a parallel line segment 1321 extending along the length direction of the flexible circuit board 130 and an inclined line segment 1322 extending at an angle relative to the length direction of the flexible circuit board 130; the two ends of the parallel line segment 1321 are respectively connected to one end of the inclined line segment 1322 and the control board 12, and the other end of the inclined line segment 1322 is connected to the electrode 14.

[0056] According to the above embodiments of this application, as Figures 1 to 4 As shown, the patch assembly 20 may also include a flexible carrier 22 stacked between the connector 13 and the conductive adhesive layer 21 to serve as a padding layer that comes into contact with human skin, providing a comfortable feel and preventing things such as the flexible circuit board 130 from coming into direct contact with human skin.

[0057] At the same time, such as Figure 2 and Figure 4 As shown, the flexible carrier 22 is provided with a conductive window 220 that can be electrically connected to the electrode 14 and the conductive adhesive layer 21, so that the electrode 14 can conduct pulse current to the conductive adhesive layer 21 through the conductive window 220, ensuring that the conductive adhesive layer 21 can better conduct pulse current to human skin and provide electrical pulse stimulation to the vagus nerve.

[0058] Optionally, such as Figure 2 and Figure 4 As shown, the flexible carrier 22 is disposed on the first surface 1303 of the flexible circuit board 130, which can provide structural support and a certain degree of insulation, thereby improving the structural strength of the connector 13 and enhancing the safety of the vagus nerve stimulation device. It is understood that the first surface 1303 mentioned in this application refers to the side surface of the flexible circuit board 130 that faces the human skin.

[0059] It is worth noting that, such as Figure 1 , Figure 2 as well as Figure 4 As shown, one end of the flexible carrier 22 can extend further to the side surface of the control plate 12 facing the human skin, so as to avoid the housing 11 and / or the control plate 12 directly contacting the human skin.

[0060] Optionally, the conductive adhesive layer 21 is detachably connected to the flexible carrier 22. In this way, when the conductive adhesive layer 21 needs to be replaced due to aging or dirt, only the conductive adhesive layer 21 needs to be replaced, instead of replacing the entire device. This allows other parts of the vagus nerve stimulation device to be reused, thus reducing the user's operating costs.

[0061] For example, the flexible carrier 22 can be, but is not limited to, a non-woven fabric layer to stably bond and fix the conductive adhesive layer 21. It is understood that the flexible carrier 22 mentioned in this application can also be implemented as a breathable sheet such as medical fabric, silicone, or a flexible polymer film, which will not be elaborated further in this application.

[0062] In addition, the conductive adhesive layer 21 can be, but is not limited to, a conductive gel with a certain degree of adhesion, so that the conductive adhesive layer 21 has the dual functions of conduction and fixation, so as to adhere to human skin, which helps to evenly conduct the pulse current generated by the electrode assembly 10 to human skin, while preventing the device from falling off or shifting during movement.

[0063] For example, such as Figure 4 As shown, the electrode 14 can protrude from the first surface 1303 of the flexible circuit board 130. In this case, the conductive window 220 can be implemented as a clearance hole 2201 that penetrates the flexible carrier 22 and allows the electrode 14 to pass through. Thus, when the conductive adhesive layer 21 is attached to human skin, the electrode 14 can pass through the clearance hole 2201 to contact the corresponding conductive adhesive layer 21 and establish an electrical connection.

[0064] It is worth noting that, since both the flexible circuit board 130 and the flexible carrier 22 have the ability to conform to shape, before the conductive adhesive layer 21 of the patch assembly 20 is attached to the human skin, the electrode 14 can abut against the conductive adhesive layer 21 or there can be a certain gap between it and the conductive adhesive layer 21; however, when the conductive adhesive layer 21 is in close contact with the human skin, the flexible circuit board 130 and the flexible carrier 22 can bend and deform along with the conductive adhesive layer 21, so that the electrode 14 passes through the clearance hole 2201 to abut against the conductive adhesive layer 21 and achieve electrical connection.

[0065] Furthermore, in one modified example of this application, such as Figure 5 As shown, the conductive window 220 can also be implemented as a conductive contact 2202 embedded in the flexible substrate 22 and electrically connected to the conductive adhesive layer 21. In this case, the electrode 14 can be embedded in or protrude from the flexible circuit board 130. Thus, when the conductive adhesive layer 21 is attached to human skin, the electrode 14 can abut against the conductive contact 2202 to make an electrical connection with the corresponding conductive adhesive layer 21.

[0066] According to the above embodiments of this application, as Figures 1 to 4 As shown, the vagus nerve stimulation device also includes a flexible covering layer 30 covering the connector 13. Preferably, the flexible covering layer 30 is disposed on the second surface 1304 of the flexible circuit board 130 facing away from the human skin, which can also play a role in structural support and insulation, thereby improving the structural strength of the connector 13 and the safety of the vagus nerve stimulation device.

[0067] It is understood that the flexible covering layer 30 mentioned in this application may also be implemented as a sheet material with good air permeability, such as a non-woven layer, medical fabric, silicone or flexible polymer film.

[0068] Preferably, the flexible covering layer 30 can be detachably connected to the flexible carrier 22, allowing the vagus nerve stimulation device to be arranged in a circle for easy placement around the neck. For example, the flexible covering layer 30 has hooked bristles, and the flexible carrier 22 has soft round bristles, facilitating a detachable connection between the two using Velcro.

[0069] It is worth noting that the control panel 12 in this vagus nerve stimulation device can be located outside the housing 11 or fixed inside the housing 11. For example, as Figure 1 and Figure 4 As shown, the housing 11 covers the side of the control board 12 facing away from human skin to encapsulate and protect the processor and electronic components on the control board 12 from damage by the external environment.

[0070] Preferably, such as Figure 2 and Figure 4 As shown, the housing 11 is detachably connected to the control panel 12 to form a relatively sealed accommodating space between the housing 11 and the control panel 12. It is understood that the detachable connection mentioned in this application can refer to mechanical connections such as snaps, clips, or Velcro, or magnetic connections; alternatively, it can also be achieved through fastening methods such as screws or nuts, which will not be elaborated upon in this application.

[0071] According to the above embodiments of this application, as Figure 2 As shown, the electrode assembly 10 in the vagus nerve stimulation device may also include a power supply module 15 disposed in the housing 11 and electrically connected to the control board 12, for supplying power to the control board 12 to provide the power required by the control board 12.

[0072] Optionally, such as Figure 2 and Figure 4 As shown, the power supply module 15 may include a built-in power supply 151 disposed within the housing 11 and electrically connected to the control board 12 for storing electrical energy. It is understood that the built-in power supply 151 mentioned in this application may, but is not limited to, be implemented as a coin cell battery, a rechargeable battery, or a rechargeable capacitor.

[0073] Preferably, such as Figure 4As shown, the built-in power supply 151 is located between the control board 12 and the housing 11, so as to be encapsulated and protected by the housing 11. It is understood that the built-in power supply 151 mentioned in this application may be electrically connected to the control board 12 by, but is not limited to, soldering or flexible contacts.

[0074] Optionally, such as Figure 2 As shown, the power supply module 15 also includes a power supply interface 152 disposed on the housing 11 and electrically connected to the control board 12, for electrically connecting to an external power source or power grid to provide power to the control board 12 via the external power source or power grid. It is understood that when the built-in power supply 151 is implemented as a rechargeable battery or rechargeable capacitor, the power supply interface 152 mentioned in this application can act as a charging interface for charging the built-in power supply 151.

[0075] It is worth noting that in other embodiments of this application, the power supply module 15 may only include the power supply interface 152 and not the built-in power supply 151; in this case, an external power supply or power grid provides power to the control board 12 through the power supply interface 152 in order to reduce the weight of the vagus nerve stimulation device.

[0076] In addition, the electrode assembly 10 mentioned in this application may also include an interactive interface, such as function buttons or a touch screen, disposed on the housing 11 and electrically connected to the control board 12, for mode switching.

[0077] It should be noted that although the vagus nerve stimulation device in the above embodiments of this application uses a flexible circuit board 130 as the connector 13, in other embodiments of this application, the connector 13 can also be implemented as a wire that electrically connects the control board 12 and the electrode 14. It is only necessary to place the wire between the flexible carrier 22 and the flexible covering layer 30. This application will not elaborate further on this.

[0078] It is worth mentioning that, according to another aspect of this application, such as Figure 6 As shown, one embodiment of this application further provides a method for preparing a vagus nerve stimulation device, which may include the following steps: S200: At least one pair of electrodes are arranged at intervals on a connector that is electrically connected to the control board and extends outward from the control board, wherein the connector has a flexible structure; S300: At least one pair of conductive adhesive layers are disposed on the connector to be electrically connected to the electrode.

[0079] It is important to note that in other examples of applications, such as Figure 6 As shown, the method for preparing this vagus nerve stimulation device may further include the following steps: S100: The control board for generating pulse current is disposed in the housing so that the free end of the connector is outside the housing.

[0080] The technical features of the above embodiments can be combined without changing the basic principles of this application. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0081] The above embodiments are merely illustrative of several implementation methods of this application, and their descriptions are quite specific and detailed. However, 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 modifications and improvements all fall within the protection scope of this application.

Claims

1. A vagus nerve stimulation device, characterized in that, include: An electrode assembly (10) includes a control board (12) for generating pulsed currents, a connector (13) electrically connected to and extending outward from the control board (12), and at least one pair of electrodes (14) spaced apart from and electrically connected to the connector (13); wherein the connector (13) has a flexible structure; and The patch assembly (20) includes at least one pair of conductive adhesive layers (21) disposed on the connector (13) and electrically connected to the electrode (14). The control board (12) is used to generate stimulation signals to be transmitted to the vagus nerve via the connector (13), the electrode (14) and the conductive adhesive layer (21).

2. The vagus nerve stimulation device according to claim 1, characterized in that, The control board (12) includes a rigid circuit board on which a microprocessor and a pulse generation circuit are arranged; the connector (13) includes a flexible circuit board (130) electrically connected to the control board (12) and the electrode (14).

3. The vagus nerve stimulation device according to claim 2, characterized in that, The flexible circuit board (130) has a fixed end (1301) that is fixedly connected to the control board (12) and a free end (1302) that is arranged away from the control board (12).

4. The vagus nerve stimulation device according to claim 3, characterized in that, The flexible circuit board (130) includes a flexible plate body (131) extending from the fixed end (1301) to the free end (1302) and fixedly connected to the electrode (14), and at least one pair of connection circuits (132) disposed on the flexible plate body (131) and electrically connecting the electrode (14) to the control board (12).

5. The vagus nerve stimulation device according to claim 4, characterized in that, Two electrodes in each pair of electrodes (14) are arranged at intervals along the length of the flexible circuit board (130) on the flexible plate (131).

6. The vagus nerve stimulation device according to claim 5, characterized in that, The length direction of the flexible circuit board (130) is the same as the extension direction of the flexible plate (131).

7. The vagus nerve stimulation device according to claim 6, characterized in that, The two connection circuits in each pair of connection circuits (132) are located on opposite sides of the line connecting the two electrodes (14) connected to each pair of connection circuits.

8. The vagus nerve stimulation device according to claim 4, characterized in that, One electrode (14) of each pair of electrodes (14) is arranged adjacent to the fixed end (1301), and the other electrode (14) of each pair of electrodes (14) is arranged adjacent to the free end (1302).

9. The vagus nerve stimulation device according to any one of claims 2 to 8, characterized in that, The patch assembly (20) further includes a flexible carrier (22) stacked between the connector (13) and the conductive adhesive layer (21); the flexible carrier (22) is provided with a conductive window (220) that can be electrically connected to the electrode (14) and the conductive adhesive layer (21).

10. The vagus nerve stimulation device according to claim 9, characterized in that, The flexible carrier (22) is disposed on the first surface (1303) of the flexible circuit board (130) facing human skin.

11. The vagus nerve stimulation device according to claim 10, characterized in that, One end of the flexible carrier (22) extends to the side surface of the control plate (12) facing the human skin.

12. The vagus nerve stimulation device according to claim 9, characterized in that, The flexible carrier (22) is selected from non-woven fabric layers, medical fabrics, silicone or flexible polymer films.

13. The vagus nerve stimulation device according to claim 9, characterized in that, The electrode (14) protrudes from the first surface (1303) of the flexible circuit board (130); the conductive window (220) is a clearance hole (2201) that passes through the flexible substrate (22) and allows the electrode (14) to pass through.

14. The vagus nerve stimulation device according to claim 9, characterized in that, The electrode (14) is embedded or protruded on the first surface (1303) of the flexible circuit board (130); the conductive window (220) is a conductive contact (2202) embedded in the flexible substrate (22) and electrically connected to the conductive adhesive layer (21).

15. The vagus nerve stimulation device according to claim 9, characterized in that, The vagus nerve stimulation device also includes a flexible covering layer (30) covering the connector (13).

16. The vagus nerve stimulation device according to claim 15, characterized in that, The flexible covering layer (30) is disposed on the flexible circuit board (130) for a second surface (1304) facing away from human skin.

17. The vagus nerve stimulation device according to claim 16, characterized in that, The flexible covering layer (30) is detachably connected to the flexible carrier (22).

18. The vagus nerve stimulation device according to any one of claims 1 to 8, characterized in that, The electrode assembly (10) also includes a housing (11) which is detachably mounted on the control panel (12) for the side facing away from human skin.

19. The vagus nerve stimulation device according to claim 18, characterized in that, The electrode assembly (10) also includes a power supply module (15) disposed in the housing (11) and electrically connected to the control board (12).

20. The vagus nerve stimulation device according to claim 19, characterized in that, The power supply module (15) includes a built-in power supply (151) disposed within the housing (11) and electrically connected to the control board (12) and / or a power supply interface (152) disposed within the housing (11) and electrically connected to the control board (12).

21. The vagus nerve stimulation device according to any one of claims 1 to 8, characterized in that, The conductive adhesive layer (21) includes a conductive gel for adhering to the skin surface.

22. The vagus nerve stimulation device according to any one of claims 1 to 8, characterized in that, The connector (13) includes at least one pair of wires that electrically connect the electrode (14) to the control board (12).

23. A method for preparing a vagus nerve stimulation device, characterized in that, Including the following steps: At least one pair of electrodes (14) are spaced apart on a connector (13) electrically connected to and extending outward from the control board (12), wherein the connector (13) has a flexible structure; and At least one pair of conductive adhesive layers (21) are disposed on the connector (13) to be electrically connected to the electrode (14).

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