Wearable device for treating or preventing headache

Abstract

Disclosed in the present invention is a wearable device for treating or preventing headache, comprising a stimulator and a flexible fixing member connected to the stimulator, wherein the flexible fixing member can fix the stimulator on the wrist, head or upper arm. The wearable device further comprises: a first electrode for targeting wrist nerves in the wrist, the stimulator being configured to provide an electric stimulation to the wrist nerves in the wrist via the first electrode; and a second electrode for targeting frontal nerves in the head and the sensory nerve C-type fibers in the upper arm, the stimulator being configured to provide an electric stimulation to the frontal nerves in the head and the sensory nerve C-type fibers in the upper arm via the second electrode. Since the wearable device can be worn on the wrist, head or upper arm, patients can freely choose a wearing position on the basis of current usage occasions and personal preferences, so as to meet the needs of the patients for use in various occasions, and achieve the convenience of daily carrying, thereby greatly improving the convenience in use of headache treatment devices, and providing users with more options.

Description

Wearable devices for treating or preventing headaches Technical Field

[0001] This application relates to the field of medical or electronic device technology, and more particularly to a wearable device for treating or preventing headaches. Background Technology

[0002] Migraine is a type of headache. Currently, the main treatment for migraine is medication. However, medication has limited effectiveness and side effects, which cannot meet the needs of many headache sufferers. Therefore, wearable headache treatment devices have emerged.

[0003] Wearable headache treatment devices deliver electrical stimulation to the body's nerves, triggering conditioned pain modulation (CPM) mechanisms to achieve pain relief and long-term prevention of migraines. Conditioned pain modulation is an endogenous pain inhibition mechanism, referring to the phenomenon that persistent pain in one part of the body can inhibit the pain perception caused by noxious stimuli in another part of the body; in other words, "pain suppresses pain."

[0004] Headache treatment devices include the External Trigeminal Nerve Stimulation Device (TTNSD). When used, the device is worn on the head or forehead. It stimulates the trigeminal nerve with electrical currents, thus relieving headaches and is suitable for relieving dizziness, motion sickness, and other head discomforts. Because the stimulation site is close to the brain, common side effects include drowsiness, fatigue, and insomnia. It must be used while at rest, and the device must be worn continuously on the forehead, making it inconvenient to use in public. Furthermore, it is not easy to carry around.

[0005] Headache treatment devices also include remote electrical neuromodulation devices. During use, the patient first fully exposes their upper arm, then the device is strapped to the upper arm. The device then releases electrical pulses to stimulate the C-type sensory fibers in the upper arm, which transmit signals to the pain center, achieving a therapeutic effect. Because the stimulation site is far from the head, the C-type sensory fibers conduct slowly, resulting in a long treatment time and slow onset of action. Prolonged stimulation can also cause side effects such as local skin tingling and hyperesthesia. Furthermore, the device requires a resting state and an exposed upper arm, making it inconvenient to use in public. It is also difficult to carry around.

[0006] Headache treatment devices also include wrist-worn headache devices, which patients can wear on their wrists daily for convenient use anytime, anywhere. They are lightweight and portable, and their watch-like or bracelet-like appearance makes them highly discreet, protecting patient privacy in public. Compared to the two treatment methods mentioned above, although this device is furthest from the head, its direct and precise stimulation of the main nerve trunk in the wrist results in rapid and efficient nerve conduction, providing quick pain relief. However, because it relies on triggering the CPM mechanism to treat headaches, its responsiveness can vary depending on the individual's sensitivity to the CPM mechanism.

[0007] Headache sufferers often experience a high frequency of attacks. For example, migraines can occur up to 30 times a month, and cluster headaches can occur up to 8 times a day. Patients may switch between private and public places every day. None of the above-mentioned headache treatment devices can meet the needs of patients to freely choose the stimulation site according to the usage situation. Carrying two or more headache treatment devices to commute every day is not only costly but also inconvenient.

[0008] Therefore, existing headache treatment devices cannot meet the needs of patients in various usage scenarios. Summary of the Invention

[0009] The embodiments of this application provide a wearable device for treating or preventing headaches, thereby addressing the technical problem that existing headache treatment devices cannot meet the needs of patients in various usage scenarios.

[0010] To address the aforementioned issues, this application provides a wearable device for treating or preventing migraines, comprising a stimulator and a flexible fastener connected to the stimulator, wherein the flexible fastener can secure the stimulator to the wrist, head, or upper arm.

[0011] It also includes a first electrode for targeting a wrist nerve on the wrist, the stimulator being configured to provide electrical stimulation to the wrist nerve on the wrist via the first electrode when the stimulator is fixed to the wrist, wherein the wrist nerve is the median nerve and / or the ulnar nerve;

[0012] It also includes a second electrode for targeting the frontal nerve of the head or sensory nerve type C fibers in the upper arm. The stimulator is configured to provide electrical stimulation to the frontal nerve via the second electrode when the stimulator is fixed to the head, and to provide electrical stimulation to the sensory nerve type C fibers of the head via the second electrode when the stimulator is fixed to the upper arm, wherein the frontal nerve is the supraorbital nerve and / or the supratrochlear nerve.

[0013] Furthermore, the stimulator includes a housing, and the first electrode and the second electrode may be at least partially exposed outside the housing to contact the wrist nerve on the wrist, the frontal nerve in the head, or the C-type sensory nerve fibers in the upper arm.

[0014] The housing contains a pulse generator for generating electrical pulses, which can be connected to the first electrode or the second electrode.

[0015] When the first electrode contacts and conducts electrical impulses with the wrist nerve on the wrist, the electrical pulses can be transmitted to the wrist nerve on the wrist through the first electrode, thereby forming electrical stimulation.

[0016] When the second electrode comes into contact with and conducts electrical impulses to the frontal nerve of the head or the sensory nerve type C fibers of the upper arm, the electrical impulses can be transmitted through the second electrode to the frontal nerve of the head or the sensory nerve type C fibers of the upper arm, thereby generating electrical stimulation.

[0017] Furthermore, the first electrode is fixed to the stimulator, and the second electrode is detachably connected to the stimulator.

[0018] Furthermore, the first electrode is electrically connected to the stimulator;

[0019] The first electrode comprises at least one set, each set comprising at least one first electrode used as an anode and at least one first electrode used as a cathode, wherein the anode and the cathode within the set are respectively used to target different locations of the wrist nerve;

[0020] When the anode and cathode within the group simultaneously contact and conduct with different locations of the wrist nerve, the stimulator, the anode, the cathode, and the wrist nerve are electrically connected to form a conductive path for conducting electrical pulses.

[0021] Furthermore, the second electrode is a flexible electrode.

[0022] Furthermore, the second electrode is detachably connected to the first electrode on the stimulator via a connection structure;

[0023] When the second electrode is connected to the first electrode via a connection structure, the first electrode is electrically connected to the stimulator to transmit the electrical pulses generated by the stimulator to the frontal nerve in the head or the C-fibers of sensory nerves in the upper arm via the second electrode, thereby forming electrical stimulation.

[0024] Furthermore, the connection structure is a snap-fit ​​structure, which includes a snap-fit ​​groove on the first electrode and a snap-fit ​​post on the second electrode, wherein:

[0025] The buckle groove is electrically connected to the first electrode, and the locking post is electrically connected to the second electrode. Both the buckle groove and the locking post are conductive. When the locking post is locked in the buckle groove, the second electrode is electrically connected to the pulse generator via the first electrode.

[0026] Furthermore, the flexible fastener includes an adhesive tape disposed around the stimulator, the back of which can be adhered and secured to the wrist, head, or upper arm.

[0027] Furthermore, the adhesive tape can be detachably connected to the back of the stimulator, and the adhesive tape has a window exposing the first electrode, through which the first electrode protrudes.

[0028] Furthermore, the flexible fastener includes a flexible band that can be formed into an adjustable ring structure, and the circumference of the ring structure can be locked to fit snugly on the wrist, head, or upper arm.

[0029] Furthermore, the flexible band is detachably connected to the stimulator.

[0030] Furthermore, the flexible band includes a first band body and a second band body disposed opposite to each other on both sides of the stimulator, wherein:

[0031] The inner ends of the first band and the second band are respectively connected to the stimulator. The first band and the second band can form an adjustable ring structure, and the circumference of the ring structure can be locked.

[0032] Furthermore, the front of the first tape body and the front of the second tape body are respectively provided with hook and loop fasteners extending along their own length direction, and the back of the outer end of the second tape body is provided with hook and loop fasteners.

[0033] The hook side of the hook and loop fastener can be bonded and fixed to the hook and loop fastener at any position, so that the first tape body and the second tape body form the ring structure with an adjustable circumference and lockable.

[0034] or:

[0035] The first and second strips are respectively provided with a first magnet extending along their own length direction, and a second magnet is provided on the back of the outer end of the second strip. The positions of the first magnet and the second magnet on the second strip are staggered.

[0036] The second magnet can be magnetically attracted and fixed to the first magnet at any position, so that the first strip and the second strip form the ring structure with an adjustable and lockable circumference.

[0037] Furthermore, a retaining ring is provided on the outer end of the first belt body, the outer end of the second belt body passes through the retaining ring, and an anti-slip plug is provided on the outer end of the second belt body to prevent the second belt body from sliding out of the retaining ring.

[0038] Furthermore, the second band is longer than the first band, and the stimulator is provided with a perforation for the second band to pass through the stimulator along its own length direction.

[0039] Since the wearable device can be worn on the wrist, head, or upper arm, patients can choose to wear it on their head or upper arm when they are in a private space and do not need to worry about being noticed by others; when patients do not need to worry about being noticed by others and it is inconvenient to expose their upper arm, they can choose to wear it on their head; when patients do not want to attract attention in public places or when the wearable device is in a non-stimulation therapy state, they can choose to wear it on their wrist. Patients can freely choose the wearing position according to the current usage occasion and preferences, which can meet the needs of patients in a variety of usage scenarios, and it is convenient to carry around every day. Attached Figure Description

[0040] Figure 1 is an exploded view of the structure of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0041] Figure 2 is an exploded view of the structure of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0042] Figure 3 is an exploded view of the structure of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0043] Figure 4 is a partial structural schematic diagram of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0044] Figure 5 is a rear view of the stimulator of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0045] Figure 6 is a schematic diagram of the structure of a stimulator in a wearable device for treating or preventing headaches according to an embodiment of this application;

[0046] Figure 7 is a schematic diagram of the structure of the second electrode of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0047] Figure 8 is a side view of the second electrode of a wearable device for treating or preventing headaches according to an embodiment of this application;

[0048] Figure 9 is an exploded view of the structure of a wearable device for treating or preventing headaches according to another embodiment of this application;

[0049] Figure 10 is a partial front view of a wearable device for treating or preventing headaches according to another embodiment of this application;

[0050] Figure 11 is a partial structural rear view of a wearable device for treating or preventing headaches according to another embodiment of this application. Specific Implementation

[0051] The embodiments of this application provide a wearable device for treating or preventing headaches, thereby addressing the technical problem that existing headache treatment devices cannot meet the needs of patients in various usage scenarios.

[0052] The technical solution of this application will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the embodiments and specific features in the embodiments are detailed descriptions of the technical solution of this application, rather than limitations thereof. In the absence of conflict, the embodiments and technical features in the embodiments can be combined with each other.

[0053] Figures 1-11 illustrate a wearable device for treating or preventing headaches (including migraines, cluster headaches, tension headaches, and other types of headaches, or head discomfort such as motion sickness and dizziness) according to an embodiment of this application. It can be worn on the patient's wrist, head, or upper arm. It achieves the effect of treating or preventing headaches by electrically stimulating the carpal nerve (in this application, the median nerve and / or ulnar nerve) on the ventral side of the wrist, the frontal nerve (in this application, the supraorbital nerve and / or supratrochlear nerve) of the head, or the C-type sensory nerve fibers in the upper arm. It is especially suitable for migraines.

[0054] Because this wearable device can be worn on the wrist, head, or upper arm, patients can choose to wear it on their head or upper arm when in a private space where they don't need to worry about attracting attention; when they don't need to worry about attracting attention and exposing their upper arm is inconvenient, they can choose to wear it on their head; and when patients do not want to attract attention in public or when the device is in a non-stimulation treatment state, they can choose to wear it on their wrist. This allows for flexible choice of wearing position, meeting the needs of patients in various usage scenarios, and it is convenient to carry daily. This application aims to improve the ease of use of headache treatment devices and provide users with more options.

[0055] It should be noted that the median nerve and ulnar nerve are two main nerves of the upper limb, which innervate different muscles and sensory areas respectively; for ease of wearing, the wearable device described in this application acts on the median nerve area and / or ulnar nerve area on the inner side of the wrist.

[0056] The supraorbital nerve and supratrochlear nerve are two branches of the ophthalmic nerve, the first branch of the trigeminal nerve. They emerge above the edge of the orbit and are distributed in the frontal sinus mucosa, the conjunctiva and skin of the upper eyelid, the skin of the forehead, and the scalp. For ease of wearing, the wearable device described in this application acts on the supraorbital nerve and / or supratrochlear nerve region of the forehead.

[0057] Sensory nerve type C fibers are a type of nerve fiber in the peripheral nervous system, mainly responsible for transmitting pain, temperature and other non-obvious tactile information; for ease of wearing, the wearable device described in this application mainly acts on the sensory nerve type C fiber innervation area on the inner side of the upper arm.

[0058] As shown in Figures 1-11, the wearable device includes a stimulator 100 and a flexible fastener connected to the stimulator 100. The flexible fastener can fix the stimulator 100 to the wrist, head, or upper arm so that the stimulator 100 fits against the nerves of the wrist, the frontal nerve of the head, or the C-type fibers of the sensory nerves of the upper arm.

[0059] As shown in Figures 1-8, the stimulator 100 includes a housing, the cross-sectional shape of which can be any shape such as square, rectangle, or circle. The housing is used to house and protect internal components (such as pulse generator, power supply, controller, communication components, etc.) located within the housing, and to house external components exposed on the outer wall of the housing (such as display screen 150, data / power port 130, switch button 110, intensity adjustment key 120, etc.).

[0060] The pulse generator is electrically connected to a power supply to generate electrical pulses. The pulse generator is also electrically connected to a controller to execute control commands. The controller is signal-connected to the pulse generator and can control the start and stop of the pulse generator and generate electrical pulses of predetermined duration, frequency, and width according to user-input control commands.

[0061] For example, the pulse generator provides an electrical pulse frequency of 40–100 Hz, a pulse width of 300 μs, and a current intensity of 10–30 mA. Specifically, the current intensity is 10–15 mA for children and 15–30 mA for adults. Treatment using these parameters achieves safe, effective, and well-tolerated results with minimal side effects. Of course, the wearable device can also operate under other modes or parameters; this is not a limitation.

[0062] The communication component is used to connect the controller and external terminal devices (such as mobile phones, tablets, computers, etc.), thereby enabling communication between the external terminal devices and the wearable device. For example, the controller can communicate with an external computing device via the communication component (e.g., wireless communication) to update software and / or parameters and / or read data. Another example is obtaining the wearable device's operating parameters on the external terminal device based on the communication component, or controlling the wearable device by inputting control commands through the external terminal device.

[0063] The wearable device described in this application embodiment can be used independently. For example, the casing is provided with one or more buttons, a display screen 150, a dial, and / or a keyboard for users to input control commands. The display screen 150 (touch display screen 150), buttons, dial, and / or keyboard are communicatively connected to the controller, allowing users to input control commands. The display screen 150 can display the working status feedback of the wearable device described in this application embodiment to the user, and can also allow the user to view the display content of other functions, such as time, weather, heart rate, sleep status, blood pressure, oxygen saturation, etc.

[0064] The wearable device described in this application embodiment can also be used in conjunction with other smart devices, such as personal computers, laptops, smartphones, tablets, smart speakers, smart TVs, smart in-vehicle devices, etc. The smart device has an application that allows communication with the wearable device and acts as a controller.

[0065] Of course, in some embodiments, the wearable device described in this application can be integrated with a smartwatch, such as an Apple Watch or an Android smartwatch, where the smartwatch provides a strap as a flexible fastener and a watch face as a stimulator 100 for the wearable device.

[0066] The power source can be a disposable dry cell battery, a rechargeable battery, or a combination of both. Disposable batteries are replaceable, while rechargeable batteries require a reserved charging interface. For example, in some embodiments, the wearable device may have a data / power port 130, such as a USB port, which allows the user to charge the power source, update the software and / or parameters on the microcontroller, and / or read data from the controller's storage unit. The controller can communicate with an external computing device through the data port to update software and / or parameters and / or read data.

[0067] In addition, to facilitate quick operation by the user, a switch button 110 can be provided on one side of the wearable device. The switch button 110 is connected to the controller, so that the user can quickly start or stop the stimulator 100.

[0068] In addition, to facilitate users in adjusting the intensity of electrical stimulation, an intensity adjustment key 120 can be provided on one side of the wearable device. The intensity adjustment key 120 is connected to the controller, so that users can input control commands to the controller. The controller generates electrical pulses of a predetermined frequency and width based on the control commands, thereby adjusting the intensity of electrical stimulation. However, the principle and implementation of adjusting the intensity of electrical stimulation through the intensity adjustment key 120 can refer to the existing technology.

[0069] As shown in Figures 1 to 5, a first electrode 300 is also fixedly provided on the back of the outer shell. The inner end of the first electrode 300 is electrically connected to the pulse generator, and the outer end is exposed outside the outer shell to contact the wrist nerve on the wrist.

[0070] The first electrode 300 includes at least one group, each group of first electrodes 300 including at least one first electrode 300 used as an anode and at least one first electrode 300 used as a cathode, and the anode and cathode in the group are respectively used to target different locations of the wrist nerve (different locations of the same wrist nerve or different wrist nerves); when the anode and cathode in the group simultaneously contact and conduct with different locations of the wrist nerve, the anode, the cathode, the wrist nerve, and the pulse generator are electrically connected to form a conductive path, thereby providing electrical stimulation to the wrist nerve.

[0071] For example, in one embodiment of this application, as shown in Figures 2-4, the first electrode 300 includes a group of two first electrodes 300 that can be spaced apart along the length of the wrist nerve (e.g., along the length of the median nerve). One of the first electrodes 300 is used as an anode and the other is used as a cathode. When the anode and cathode simultaneously contact and conduct with different parts of the median nerve or ulnar nerve, or when the anode and cathode contact and conduct with the median nerve and ulnar nerve respectively, the anode, cathode, wrist nerve, and pulse generator are electrically connected to form a conductive path.

[0072] Electrical pulses are delivered via the first electrode 300 to the median and / or ulnar nerves in the wrist, transmitting the electrical pulses generated by the stimulator 100 to a pathway formed by the sequential connection of the median (or ulnar) nerve in the wrist, the spinal nerve, the trigeminal nerve cervical complex, the thalamus, and the cerebral cortex. This pathway shares a common integrative center (the thalamus) and a common convergent endpoint (the cerebral cortex) with the neural conduction pathway of headache (formed sequentially by the trigeminal nerve, the trigeminal nucleus, the trigeminothalamic plexus in the brainstem, the thalamus, and the cerebral cortex). Therefore, by stimulating the median and / or ulnar nerves in the wrist, conditioned pain modulation mechanisms are triggered, thereby achieving pain relief and long-term prevention of migraines, significantly reducing the disease burden of headache patients, and improving their quality of life.

[0073] Because the wrist-worn device resembles a watch or bracelet in appearance, patients wear it on their wrists daily, just like a regular watch. The stimulator 100 is located on the back of the wrist. When it is needed to treat and prevent headaches, the stimulator 100 is moved to the front of the wrist and turned on. It is convenient to use and can be used anytime and anywhere. It is lightweight and portable, and has good concealment, which helps protect the patient's privacy.

[0074] Of course, in the above embodiments, any anode may also be provided with two or more first electrodes 300, and any cathode may also be provided with two or more first electrodes 300 to enhance conduction efficiency and improve stimulation effect.

[0075] The second electrode 400 is a flexible electrode, and it is detachably connected to the first electrode 300, meaning the second electrode 400 is connected to the stimulator 100 via the first electrode 300. Thus, when applied to the wrist, the second electrode 400 can be removed, and when applied to the head or upper arm, it can be installed, resulting in better space utilization and a more compact overall design. Alternatively, the second electrode 400 can also be detachably connected directly to the outer shell of the stimulator 100, allowing for switching between the first electrode 300 and the second electrode 400 to achieve selective use; this is not a limitation.

[0076] Furthermore, due to its bendability, foldability, and stretchability, the flexible electrode is highly skin-friendly and has a planar structure, eliminating any point-like abrasions and providing a high level of comfort during use. In addition, the flexible electrode can be replaced after wear or damage. Timely replacement with a new flexible electrode when its conductivity decreases avoids overheating and skin burns, improving safety and extending the overall lifespan of the stimulator 100, thus reducing overall operating costs. Simultaneously, since migraine attacks are intermittent, the electrical stimulation function can be turned off and the flexible electrode removed and stored separately during non-migraine periods when no attack is needed, reducing unnecessary wear and tear and further extending its lifespan, thereby reducing operating costs.

[0077] For example, in one embodiment of this application, the flexible electrode is snapped together with the first electrode 300, making it very convenient to install and remove.

[0078] Specifically, each of the two first electrodes 300 is fixed with a snap-fit ​​groove 310, which is electrically connected to the pulse generator. The flexible electrode is provided with a snap-fit ​​post 410 that can be snapped and fixed with the snap-fit ​​groove 310. The snap-fit ​​post 410 is electrically connected to the flexible electrode. The snap-fit ​​post 410 and the snap-fit ​​groove 310 are a connection structure.

[0079] Both the latching slot 310 and the retaining post 410 are made of conductive materials, such as copper or aluminum. When the retaining post 410 is latched into the latching slot 310, the flexible electrode is fixed to the outer shell and connected to the pulse generator; when the retaining post 410 is pulled out of the latching slot 310, the flexible electrode is separated from the outer shell, allowing for replacement of the flexible electrode. The conductive latching slot 310 and retaining post 410 enable both a physically detachable connection between the flexible electrode and the stimulator 100 and an electrical connection between the flexible electrode and the stimulator 100, resulting in a compact overall structure.

[0080] In addition, the groove 310 is provided on the first electrode 300, and the groove 310 is recessed in the first electrode 300 or the outer surface of the groove 310 is flush or approximately flush with the outer surface of the first electrode 300. This ensures that the flexible electrode is flat when it is fastened to the first electrode 300, which is conducive to the flexible electrode fully aligning with and contacting the nerve to be targeted, thus ensuring the electrical stimulation effect of the second electrode 400. It also ensures that the surface of the first electrode 300 in contact with the skin is smooth after the flexible electrode is removed, thereby improving the comfort of wearing the wrist-worn device after the flexible electrode is removed.

[0081] When the wearable device is worn on the head, electrical pulses are sent to the frontal nerve via the second electrode 320. When the frontal nerve merges into the trigeminal nerve, the electrical pulses emitted by it are transmitted to the trigeminal nucleus, directly stimulating and regulating the trigeminal nucleus. This directly regulates the excitability of the trigeminal nucleus during a migraine attack, thereby achieving the therapeutic effect of inhibiting migraine attacks.

[0082] Similarly, when the wearable device is worn on the upper arm, the electrical pulses are transmitted through the second electrode 320 to the C-fibers of the pain nerves in the upper arm nerves. The pain signals caused by the electrical stimulation are transmitted upward to the pain centers in the thalamus and cerebral cortex, ultimately triggering the endogenous pain inhibition mechanism - the effect of conditioned pain modulation (CPM), thereby achieving the effect of pain relief treatment for migraines.

[0083] Of course, the buckle groove 310 can also be directly set on the outer shell. For example, the buckle groove 310 is set on the outer shell between the two first electrodes 300, and the buckle groove 310 is directly electrically connected to the pulse generator. That is, the flexible electrode is directly electrically connected to the pulse generator through the buckle groove 310 and the locking post 410.

[0084] Of course, the flexible electrode can also be detachably connected to the stimulator in other ways, such as by threaded connection. For example, a threaded connection hole can be provided on the outer shell or the first electrode 300, and a threaded connection post can be provided on the flexible electrode. The flexible electrode and the outer shell are screwed together and fixed through the threaded connection post and the threaded connection hole. Both the threaded connection post and the threaded connection hole are made of conductive material, which can realize the electrical connection between the flexible electrode and the pulse generator.

[0085] Of course, the second electrode can also be other electrodes, such as metal electrodes, etc., and there is no limitation here.

[0086] Furthermore, the two ends of the clamping post 410 are clamped and fixed to the front and back surfaces of the flexible electrode.

[0087] The bottom end of the clamping post 410 passes through the flexible electrode. The bottom end of the clamping post 410 is provided with a front piece and a rear piece for clamping the front and back sides of the flexible electrode. The front piece and the rear piece are fixedly connected to the clamping post 410, so that the clamping post 410 and the flexible electrode are fixed together.

[0088] In addition to the stick 410 itself being electrically connected to the flexible electrode, the front and rear pieces are both conductive and electrically connected to the stick 410, thereby enhancing the connection effect between the stick 410 and the flexible electrode. The front and rear pieces increase the contact area with the flexible electrode, thereby improving the physical fixation strength of the stick 410 on the flexible electrode.

[0089] Furthermore, at least one edge of the flexible electrode extends beyond the corresponding back sheet to prevent the back sheet from safely covering the flexible electrode and affecting the stimulation effect.

[0090] The wrist circumference of a typical adult is 13–20 cm, the head circumference is 54–58 cm, and the upper arm circumference is 20–35 cm. The wearable device in this application is designed to be worn on the head, upper arm, and wrist, where there are significant differences in circumference. Therefore, the flexible fastener must have good adaptability and / or adjustability. The flexibility of the fastener refers to its ability to change shape flexibly according to different body parts, thereby better conforming to the wrist, head, or upper arm.

[0091] For example, in one embodiment of this application, as shown in Figures 9-11, the flexible fixing member is an adhesive tape 230 disposed around the stimulator. The back of the adhesive tape 230 is adhesive and can be adhered and fixed to the wrist, head, or upper arm. The adhesive fixing is highly adaptable, without needing to consider the dimensional differences of the head, upper arm, and wrist. Furthermore, the adhesive tape 230 itself is flexible and can well conform to the curvature of the wrist, head, or upper arm, effectively fixing the stimulator to the stimulation site.

[0092] Furthermore, the adhesive tape 230 is disposed opposite to both sides of the stimulator 100 to bond and fix the stimulator 100 to the wrist, head, or upper arm from both sides, which has a good fixing effect, reduces the bonding area, and improves wearing comfort. Of course, the adhesive tape 230 can also be provided in two or more pairs, or arranged in a whole circle around the outer periphery of the stimulator 100 to enhance the fixing effect.

[0093] Furthermore, the adhesive tape 230 is made of silicone gel, which can reliably adhere to the skin, while being easy to remove and reposition without causing damage to the skin or discomfort due to adhesion, and can be repeatedly applied and reused.

[0094] In addition, to facilitate the replacement of the adhesive tape 230, the adhesive tape 230 can be detachably connected to the back of the stimulator 100. For example, the back of the stimulator 100 housing is provided with a hook and loop side, and the adhesive tape 230 is provided with a hook and loop side. The stimulator 100 and the adhesive tape 230 are detachably connected by hook and loop fastening. The adhesive tape is provided with a window that exposes the first electrode 300. The window allows the first electrode 300 to pass through so as not to affect the contact of the first electrode 300 with the wrist nerve.

[0095] In another embodiment of this application, as shown in Figures 1-4, the flexible fastener is a flexible band, such as a silicone band, leather band, or nylon webbing. The flexible band can be formed into an adjustable-circumference ring structure, and the circumference of the ring structure can be locked to fit snugly around the wrist, head, or upper arm, thereby binding the stimulator 100 to the wrist, head, or upper arm. Thus, the size of the ring structure can be adjusted to accommodate wrists, heads, or upper arms of different sizes. For example, the circumference of the ring structure can range from 10 to 65 cm to encompass the wrist circumference, head circumference, and upper arm circumference of a typical person.

[0096] The flexible band includes a first band body 210 and a second band body 220 disposed opposite to each other on both sides of the stimulator 100. The inner ends of the first band body 210 and the second band body 220 are respectively connected to the stimulator 100. The first band body 210 and the second band body 220 can form a ring structure that fits tightly on the wrist, head or upper arm. The circumference of the ring structure is adjustable and lockable.

[0097] For example, the front of the first strap 210 and the front of the second strap 220 are both hook and loop fastener surfaces. The back of the outer end of the second strap 220 is provided with a hook and loop fastener surface 222, which can be glued and fixed to the hook and loop fastener surface. In this way, when the hook and loop fastener surface 222 on the second strap 220 is glued to the hook and loop fastener surface on the front of the first strap 210 or the hook and loop fastener surface on the front of the second strap 220, ring structures of different sizes will be formed, thereby adapting to the wrist, head, or upper arm.

[0098] When the wearable device is worn on the head, the stimulator 100 is aligned with the frontal nerve, and the first band 210 and the second band 220 are wrapped around the head. The second band 220 is tightened, and the hook and loop face 222 on the back of the second band 220 adheres to the hook and loop face, thereby forming a ring structure that can be tied and fixed on the head. Because the head is large, the hook and loop face 222 on the back of the second band 220 will adhere to the hook and loop face of the first band 210.

[0099] When the wearable device is worn on the wrist, the stimulator 100 is aligned with the wrist nerve, and the first band 210 and the second band 220 are wrapped around the wrist. The second band 220 is tightened, and the hook and loop face 222 on the back of the second band 220 adheres to the loop face, thereby forming a loop structure that can be bound and fixed on the wrist. Since the wrist is thin, the second band 220 may be wrapped around the wrist multiple times. Finally, the hook and loop face 222 on the back of the second band 220 will adhere to the loop face on the front of the second band 220 that has been wrapped around the wrist.

[0100] When the wearable device is worn on the upper arm, the stimulator 100 is aligned with the skin on the inner side of the upper arm (the area innervated by C-type sensory nerve fibers), and the first band 210 and the second band 220 are wrapped around the upper arm. The second band 220 is tightened, and the hook and loop face 222 on the back of the second band 220 is made to adhere to the loop face, thereby forming a ring structure that can be bound and fixed on the upper arm. Since the upper arm is of moderate thickness, the hook and loop face 222 on the back of the second band 220 may adhere to the loop face of the first band 210 or the loop face of the second band 220 due to the different thickness of the upper arm.

[0101] Alternatively, the first band 210 and the second band 220 may be provided with a first magnet extending along their own length direction, and a second magnet may be provided on the back of the outer end of the second band 220. The positions of the first magnet and the second magnet on the second band 220 may be staggered, and the second magnet may be magnetically attracted and fixed to the first magnet. Thus, when the second magnet on the second band 220 attracts the first magnet on the first band 210, or vice versa, ring structures of different sizes will be formed, thereby adapting to the wrist, head, or upper arm.

[0102] Thus, when the wearable device is worn on the head, the stimulator 100 is aligned with the frontal nerve, and the first band 210 and the second band 220 are wrapped around the head. The second band 220 is tightened, and the second magnet on the back of the second band 220 attracts the first magnet, thereby forming a ring structure that can be bound and fixed on the head. Because the head is large, the second magnet on the back of the second band 220 will attract the first magnet on the first band 210.

[0103] When the wearable device is worn on the wrist, the stimulator 100 is aligned with the wrist nerve, and the first band 210 and the second band 220 are wrapped around the wrist. The second band 220 is tightened, and the second magnet on the back of the second band 220 attracts the first magnet, thereby forming a loop structure that can be bound and fixed to the head. Since the wrist is thin, the second band 220 may be wrapped around the wrist multiple times. Finally, the second magnet on the back of the second band 220 will attract the first magnet on the second band 220 that is already wrapped around the wrist.

[0104] When the wearable device is worn on the upper arm, the stimulator 100 is aligned with the skin on the inner side of the upper arm (the area innervated by C-type sensory nerve fibers), and the first band 210 and the second band 220 are wrapped around the upper arm. The second band 220 is tightened, and the second magnet on the back of the second band 220 attracts the first magnet, thereby forming a ring structure that can be bound and fixed on the upper arm. Since the upper arm is of moderate thickness, the second magnet on the back of the second band 220 may attract the first magnet on the first band 210 or the first magnet on the second band 220 depending on the thickness of the upper arm.

[0105] It should be noted that, in the embodiments of this application, the back side refers to the side facing the patient's skin when worn, and the front side refers to the side facing outwards when worn.

[0106] In the above embodiment, the length of the second strap 220 is longer than that of the first strap 210. The length of the first strap 210 is 8-12cm, and the length of the second strap 220 is 50-60cm. Thus, when worn on the wrist, it is only necessary to wrap the second strap 220 around the wrist multiple times. Since the length of the first strap 210 is less than the width of an adult's wrist, it does not need to be wrapped multiple times, which is convenient for wearing.

[0107] In the above embodiment, a fixing ring 211 is provided on the outer end of the first band 210, and the outer end of the second band 220 passes through the fixing ring 211. An anti-slip plug 221 is provided on the outer end of the second band 220 to prevent the second band 220 from sliding out of the fixing ring 211, thereby avoiding accidental complete separation of the first band 210 and the second band 220 and reducing the risk of the wearable device falling off the patient. At the same time, the first band 210 and the second band 220 have consistent movement due to the restraint of the anti-slip plug 221 and the fixing ring 211. Pulling the second band 220 along the fixing ring 211 can simultaneously pull the first band 210 and the second band 220, adjusting the size of the ring structure. The operation is simple, and the second band 220 presses down on the outer end of the first band 210, preventing the outer end of the first band 210 from flipping outward, making it more convenient to wear with one hand.

[0108] In the above embodiment, the outer shell is provided with a perforation 140 for the second strap 220 to pass through the outer shell along its own length direction. Thus, when the wearable device is worn on the wrist, the second strap 220, which needs to be wrapped around the wrist multiple times, can pass through the perforation 140 without covering the display screen 150 on the front of the stimulator 100. Of course, the width of the second strap 220 and the perforation 140 is narrower than that of the stimulator 100, and there is still sufficient space inside the outer shell to accommodate other components.

[0109] In addition, in some embodiments of this application, the wearable device can also employ a combination of adhesive tape 230 and flexible tape. That is, the stimulator 100 can be equipped with both adhesive tape 230 and flexible tape simultaneously. In this case, both adhesive tape 230 and flexible tape are detachably connected to the stimulator 100. When the stimulator 100 is used on the head and upper arm, the adhesive tape 230 is used, and the flexible tape is removed; when the stimulator 100 is used on the wrist, the flexible tape is used, and the adhesive tape 230 is removed. However, since the flexible tape only acts on the wrist, its length does not need to be excessive. The length of the first tape body 210 is 8–12 cm, and the length of the second tape body 220 is 10–15 cm.

[0110] The detachable connection between the adhesive tape 230 and the stimulator 100 can refer to the aforementioned structure. The detachable connection between the flexible tape and the stimulator 100 can be implemented in one of the following ways; of course, other methods are also possible and are not limited here:

[0111] For example, the stimulator 100 has fixing rings on both sides, and hooks are provided at the inner ends of the first band 210 and the second band 220, respectively. The hooks are detachably connected to the fixing rings. Specifically, the hook has a hook body and a closed body rotatably connected to the hook body. When the hook body hooks the fixing ring, in its natural state, the closed body and the hook body enclose to form a closed ring, thereby fixing the first band 210 and the second band 220 to the fixing ring. When the closed body is pressed, the closed body rotates, forming a gap between it and the hook body, so that the first band 210 and the second band 220 can be removed from the fixing ring.

[0112] Alternatively, both the inner ends of the first belt body 210 and the second belt body 220 are provided with fastening components. The fastening components include tenons and mortises. The inner ends of the first belt body 210 and the second belt body 220 are inserted into the fixing ring and bent. The bent portions of the first belt body 210 and the second belt body 220 and the main body are respectively provided with tenons and mortises. The first belt body 210 and the second belt body 220 can be fixed on the fixing ring by fastening the tenons and mortises. Under the action of external force, the tenons and mortises separate, so that the first belt body 210 and the second belt body 220 can be removed from the fixing ring.

[0113] Alternatively, the stimulator 100 may have a pair of shaft holes on each side, with a rotating shaft fixedly passing through the inner ends of the first belt 210 and the second belt 220. The rotating shaft may be deformable, for example, made of stainless steel. Under external force, both ends of the rotating shaft can be inserted into the pair of shaft holes on the same side of the stimulator 100, thus rotatably connecting the rotating shaft to both sides of the stimulator 100. Under external force, the rotating shaft can also be removed from the shaft holes, thereby separating the first belt 210 and the second belt 220 from the stimulator 100, achieving a detachable connection between the flexible belt and the stimulator 100.

[0114] Of course, the fixing member can also be other structures that can fix the stimulator 100 to the wrist, and is not limited thereto. For example, in another embodiment of this application, the flexible fixing member is or is partially an elastic ring. The elastic ring can be stretched to fit over the wrist, head or upper arm, and the ring shrinks under its own elasticity to tighten around the wrist, head or upper arm to form a fixation.

[0115] The above description is merely a preferred embodiment of this application and is not intended to limit this application in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the method of this application, and these improvements and additions should also be considered within the scope of protection of this invention. Any modifications, alterations, and equivalent variations made by those skilled in the art without departing from the spirit and scope of this application, based on the disclosed technical content, are equivalent embodiments of this application. Furthermore, any modifications, alterations, and variations made to the above embodiments based on the essential technology of this application still fall within the scope of the technical solution of this application.

Claims

1. A wearable device for treating or preventing migraines, characterized in that, It includes a stimulator and a flexible fastener connected to the stimulator, the flexible fastener being able to secure the stimulator to the wrist, head or upper arm; It also includes a first electrode for targeting a wrist nerve on the wrist, the stimulator being configured to provide electrical stimulation to the wrist nerve on the wrist via the first electrode when the stimulator is fixed to the wrist, wherein the wrist nerve is the median nerve and / or the ulnar nerve; It also includes a second electrode for targeting the frontal nerve of the head or sensory nerve type C fibers in the upper arm. The stimulator is configured to provide electrical stimulation to the frontal nerve via the second electrode when the stimulator is fixed to the head, and to provide electrical stimulation to the sensory nerve type C fibers of the head via the second electrode when the stimulator is fixed to the upper arm, wherein the frontal nerve is the supraorbital nerve and / or the supratrochlear nerve.

2. The wearable device for treating or preventing migraines as described in claim 1, characterized in that, The first electrode is fixed to the stimulator, and the second electrode is detachably connected to the stimulator.

3. A wearable device for treating or preventing migraines as described in claim 2, characterized in that, The first electrode is electrically connected to the stimulator; The first electrode comprises at least one set, each set comprising at least one first electrode used as an anode and at least one first electrode used as a cathode, wherein the anode and the cathode within the set are respectively used to target different locations of the wrist nerve; When the anode and cathode within the group simultaneously contact and conduct with different locations of the wrist nerve, the stimulator, the anode, the cathode, and the wrist nerve are electrically connected to form a conductive path for conducting electrical pulses.

4. A wearable device for treating or preventing migraines as described in claim 2 or 3, characterized in that, The second electrode is a flexible electrode.

5. A wearable device for treating or preventing migraines as described in claim 2, characterized in that, The second electrode is detachably connected to the first electrode on the stimulator via a connection structure; When the second electrode is connected to the first electrode via a connection structure, the first electrode is electrically connected to the stimulator to transmit the electrical pulses generated by the stimulator to the frontal nerve in the head or the C-fibers of sensory nerves in the upper arm via the second electrode, thereby forming electrical stimulation.

6. A wearable device for treating or preventing migraines as described in claim 5, characterized in that, The connection structure is a snap-fit ​​structure, which includes a snap-fit ​​groove on the first electrode and a snap-fit ​​post on the second electrode, wherein: The buckle groove is electrically connected to the first electrode, and the locking post is electrically connected to the second electrode. Both the buckle groove and the locking post are conductive. When the locking post is locked in the buckle groove, the second electrode is electrically connected to the pulse generator via the first electrode.

7. A wearable device for treating or preventing migraines as described in claim 1, characterized in that, The flexible fastener includes an adhesive tape disposed around the stimulator, the back of which can be adhered to and fixed to the wrist, head, or upper arm.

8. A wearable device for treating or preventing migraines as described in claim 7, characterized in that, The adhesive tape is detachably connected to the back of the stimulator, and the adhesive tape has a window exposing the first electrode, through which the first electrode protrudes.

9. A wearable device for treating or preventing migraines as described in claim 1 or 7, characterized in that, The flexible fastener includes a flexible band that can be formed into an adjustable ring structure, and the circumference of the ring structure can be locked to fit snugly on the wrist, head, or upper arm.

10. A wearable device for treating or preventing migraines as described in claim 9, characterized in that, The flexible band is detachably connected to the stimulator.

11. A wearable device for treating or preventing migraines as described in claim 9, characterized in that, The flexible band includes a first band body and a second band body disposed opposite to each other on both sides of the stimulator, wherein: The inner ends of the first band and the second band are respectively connected to the stimulator. The first band and the second band can form an adjustable ring structure, and the circumference of the ring structure can be locked.

12. A wearable device for treating or preventing migraines as described in claim 11, characterized in that, The first tape body and the second tape body are respectively provided with hook and loop fasteners extending along their own length direction on the front side and the second tape body is provided with hook and loop fasteners on the back side of the outer end of the second tape body. The hook side of the hook and loop fastener can be bonded and fixed to the hook and loop fastener at any position, so that the first tape body and the second tape body form the ring structure with an adjustable circumference and lockable. or: The first and second strips are respectively provided with a first magnet extending along their own length direction, and a second magnet is provided on the back of the outer end of the second strip. The positions of the first magnet and the second magnet on the second strip are staggered. The second magnet can be magnetically attracted and fixed to the first magnet at any position, so that the first strip and the second strip form the ring structure with an adjustable and lockable circumference.

13. A wearable device for treating or preventing migraines as described in claim 11, characterized in that, The outer end of the first belt is provided with a fixing ring, the outer end of the second belt is inserted into the fixing ring, and the outer end of the second belt is provided with an anti-slip plug to prevent the second belt from sliding out of the fixing ring.

14. A wearable device for treating or preventing migraines as described in claim 12 or 13, characterized in that, The second band is longer than the first band, and the stimulator has a perforation for the second band to pass through the stimulator along its own length.

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