Micro-current electrical stimulation medical device and sleep regulation and control system

Abstract

The invention discloses a micro-current electrical stimulation medical device and a sleep regulation and control system, and relates to the technical field of micro-current stimulation nerve regulation. The device comprises a controller and a current generator, and an earplug main body which is provided with a first stimulation electrode which is in contact with the auricle and is used for outputting a transcranial micro-current stimulation signal through the auricle; the earplug accessory extends towards the direction of the antihelix feet based on the earplug main body, the earplug accessory has compliance and can be matched with the shape of the antihelix, and the far end of the earplug accessory is clamped and fixed in the triangular nest between the antihelix feet; a second stimulating electrode is arranged on the earplug accessory, is in contact with the antihelix foot and / or the triangular fossa and is used for outputting a percutaneous micro-current stimulating signal through the antihelix foot and / or the triangular fossa; and the anti-falling structure is used for fixing and limiting the earplug so as to form resistance for separating the first stimulating electrode and the second stimulating electrode from the ear skin. According to the invention, safe and reliable composite micro-current stimulation can be provided.

Description

Technical Field

[0001] The present invention relates to the technical field of microcurrent stimulation nerve regulation, and in particular to a microcurrent electrical stimulation medical device and a sleep regulation system. Background Art

[0002] Microcurrent therapy (MCT) is a therapeutic method that uses microcurrents to stimulate human tissues, promoting cell repair, relieving pain, and improving function. It uses microcurrents below the human perception threshold to pass through tissues. Cells in the body have their own electrical impulses. Abnormalities or damage can disrupt these cellular bio-frequency frequencies. Microcurrent therapy works on this principle, mimicking the body's natural bioelectrical signals to influence cellular metabolism and repair processes. Microcurrents can enhance mitochondrial energy metabolism and accelerate tissue repair. They can also regulate neurotransmitters, increasing the production of neurotransmitters such as serotonin, dopamine, dehydroepiandrosterone, and endorphins, thereby stabilizing the neurohormonal system. Furthermore, microcurrents can stimulate vasodilation, increasing local oxygen and nutrient delivery, and improving blood circulation. They can also inhibit pro-inflammatory cytokines (such as IL-6 and TNF-α), alleviating chronic pain. Microcurrents are effective for chronic pain conditions such as soft tissue inflammation, muscle pain, and neuropathy.

[0003] The method of applying current in microcurrent therapy varies depending on the treatment goal and site of action. It primarily includes transcranial electrical stimulation (CES) and transcutaneous electrical nerve stimulation (TENS, also known as transcutaneous electrical nerve stimulation). CES primarily regulates brain nerves, using a constant, low-intensity current to modulate cortical neuronal activity, regulate brain waves (such as increasing alpha waves), and influence the secretion of GABA, serotonin, and melatonin. It can be used to improve symptoms such as sleep, anxiety, and depression, and is a safe, non-invasive brain stimulation technique. Currently, mainstream CES devices on the market, such as the Alpha-Stim and Fisher Wallace, apply microcurrent to the brain via electrodes placed on the earlobes (typically clip-on electrodes) or on the forehead (typically patch electrodes). These devices feature two different electrodes, made of either conductive gel or metal, ensuring good skin contact. During operation, the current generator generates a low-intensity (usually 0.5-4 mA) and low-frequency (0.5-100 Hz) microcurrent, and the control module adjusts the current intensity, frequency, and treatment time (usually 20-60 minutes). Taking the Alpha-Stim device as an example, it clips two ear clip electrodes on the left and right earlobes of the patient's left and right ears respectively ( Figure 1 The front and outer structures of the external ear are shown. The ear clip electrode is located at Figure 1The earlobe is located on the earlobe of the patient (the earlobe is located on the earlobe). This electrical stimulation waveform, with a specific waveform, frequency, and intensity, is delivered to the body via the earlobe electrodes. The current signal is transmitted from one earlobe electrode through the skin and skull to the target brain area (such as the limbic system and prefrontal cortex), and then returns to the other earlobe electrode, forming a closed circuit. Transcutaneous electrical stimulation (TENS) primarily delivers specific low-frequency pulses of current through the skin to relieve pain and treat disease. In recent years, TENS has been combined with acupuncture points in traditional medicine to create transcutaneous electrical acupoint stimulation (TEAS), which is used to stimulate local nerves at these points.

[0004] Taking into account the portability and electrical stimulation effect of the device, the prior art provides a portable device that can provide multiple types of electrical stimulation. For example, Chinese patent application CN201910541838.4 provides a portable sleep-aiding device, including a head-mounted main body and a first electrode patch, an ear clip electrode and a second electrode patch, and a control circuit board is provided in the main body; the first electrode patch is electrically connected to the first output end of the control circuit board for outputting low-frequency electrical pulses to the forehead nerve endings; the ear clip electrode is clamped on the earlobe, and the ear clip electrode is electrically connected to the second output end of the control circuit board for outputting CES transcranial microcurrent pulses to the earlobe; the second electrode patch is attached to the Anmian acupoint, and the second electrode patch is electrically connected to the third output end of the control circuit board for outputting low-frequency electrical pulses to the Anmian acupoint. The present invention has the functions of forehead electrical stimulation to help sleep, CES microcurrent introduction into the earlobe to help sleep, and electrical stimulation of the Anmian acupoint to help sleep. Alternating and comprehensive use can help users better improve insomnia and avoid the side effects and drug dependence caused by long-term medication.

[0005] However, the earlobe-clipped electrodes used to output CES have wearing comfort issues. For example, the clamping force of some ear-clip CES devices is too strong, and wearing them for a long time may cause pain or pressure in the auricle, especially for users with sensitive ears. Reducing the clamping force of the ear clip will cause the electrode to fall off easily, resulting in poor contact between the electrode and the skin. Unstable contact between the electrode and the skin will lead to unstable transmission of the treatment current, with the current fluctuating, which may cause tingling or ineffective stimulation, resulting in reduced treatment effect or user discomfort. On the other hand, individual differences will affect adaptability. For example, some users' earlobes are not conducive to ear clip clamping, and they may find it difficult to find a suitable wearing position, resulting in unstable current conduction or poor stimulation effect. Summary of the Invention

[0006] The present invention aims to overcome the shortcomings of the prior art and provide a microcurrent electrical stimulation medical device and sleep regulation system. The transcranial microcurrent electrical stimulation medical device provided by the present invention uses an earplug-type stimulation electrode to perform transcranial microcurrent stimulation (CES). At the same time, a second stimulation electrode is formed based on the earplug body to extend. The second stimulation electrode contacts other parts of the ear to perform local transcutaneous microcurrent stimulation (TENS). The earplug is provided with an anti-drop structure that limits the position of the earplug, ensuring good contact between the electrode and the skin, thereby providing safe and reliable composite microcurrent stimulation.

[0007] To achieve the above objectives, the present invention provides the following technical solutions: A microcurrent electrical stimulation medical device, comprising a controller and a current generator, and: The earplug body is worn on the ear canal or auricle, and is provided with a first stimulation electrode, which contacts the auricle and outputs a transcranial microcurrent stimulation signal through the auricle; The earplug accessory extends from the earplug main body toward the crus of the antihelix, is compliant and adaptable to the shape of the antihelix, and the distal end of the earplug accessory is fixed in the triangular fossa between the crus of the antihelix; the earplug accessory is provided with a second stimulation electrode, which contacts the crus of the antihelix and / or the triangular fossa and is used to output a transcutaneous microcurrent stimulation signal through the crus of the antihelix and / or the triangular fossa; The anti-detachment structure is used to fix and limit the earplug to form resistance to the first stimulation electrode and the second stimulation electrode being detached from the ear skin.

[0008] Furthermore, a left earplug and a right earplug are provided for the left ear and the right ear, respectively, and a left ear electrode and a right ear electrode are provided on the left earplug body and the right earplug body, respectively, to form the first stimulation electrode; During transcranial microcurrent stimulation, the microcurrent stimulation signal emitted by the current generator flows into one of the ear electrodes, passes through the head tissue, and then returns from the ear electrode on the other side, forming a closed loop.

[0009] Furthermore, the current generator is configured to include a single-stage mode and a double-stage mode. In the monopolar mode, one ear electrode serves as the active electrode and the other electrode serves as the reference electrode, with the current flowing from the active electrode to the reference electrode; In bipolar mode, the two ear electrodes alternate as positive and negative electrodes based on a preset time period, and the direction of the current is periodically reversed according to the time period.

[0010] Furthermore, the earplug body includes a housing member, one end of which is provided with components, and the other end of which is provided with an earplug head for inserting into the ear canal or the concha cavity of the auricle, and the first stimulation electrode is provided on the earplug head; The first stimulation electrode includes a metal ring and a conductive soft rubber sleeve. The metal ring is located at a position close to the auricle of the earplug head. The metal ring is electrically connected to the current generator through a first transmission cable. The first microcurrent stimulation signal generated by the current generator is transmitted to the metal ring through the cable. The conductive soft rubber sleeve is arranged on the outer periphery of the metal ring and keeps contact with the metal ring. At the same time, the conductive soft rubber sleeve is embedded in the concha cavity and keeps contact with the concha, so as to transmit the first microcurrent stimulation signal to the human body through the auricle.

[0011] Furthermore, the first stimulation electrode further includes a pressure sensor disposed on the outside of the conductive soft rubber sleeve for detecting contact pressure between the conductive soft rubber sleeve and the surface of the concha; the conductive soft rubber sleeve includes an expandable bladder cavity, which is connected to a filling device and a suction device; the pressure sensor, the filling device, and the suction device are all connected to a controller and receive control from the controller; The controller is configured to: receive a pressure signal detected by a pressure sensor, and when the pressure signal is less than a preset first threshold, control the filling device to fill the cavity of the conductive soft rubber sleeve with a medium, thereby increasing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha through the expansion of the cavity; and when the pressure signal is greater than a preset second threshold, control the suction device to suck the medium from the cavity of the conductive soft rubber sleeve, thereby reducing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha through the shrinkage of the cavity.

[0012] Furthermore, the second stimulation electrode includes electrodes arranged in pairs and spaced apart to form a positive electrode and a negative electrode of a current loop, respectively, and the positive electrode and the negative electrode are located on the left and right sides of the local area to be stimulated, respectively; Corresponding to the crus helix and / or triangular fossa, a plurality of second stimulation electrodes are provided on the earplug accessory to output transcutaneous microcurrent stimulation signals to the skin of the crus helix and / or triangular fossa area respectively.

[0013] Furthermore, the earplug accessory includes a flexible soft-gel body, the proximal end of the flexible soft-gel body being connected to the earplug body, and the distal end being a free end; a flexible protrusion is provided on the side of the distal end close to the ear, and the shape of the flexible protrusion is adapted to the shape of the triangular fossa between the crus of the antihelix so that the protrusion can be fixed in the triangular fossa, thereby forming the aforementioned anti-drop structure; The flexible soft-gel body is a curved hollow structure, in which a lumen is provided for the passage of a second transmission cable. One end of the second transmission cable is electrically connected to the current generator, and the other end is electrically connected to the electrode on the surface of the flexible soft-gel body; the second microcurrent stimulation signal generated by the current generator is transmitted to the electrode on the surface of the flexible soft-gel body through the second transmission cable.

[0014] Furthermore, a tubular flexible support member is provided in the lumen of the flexible soft rubber body, and the flexible support member is used to form a support structure of the flexible soft rubber body while maintaining the flexibility of the flexible soft rubber body; The flexible support member includes a rigid tube unit and a flexible joint unit, and the rigid tube units are connected by the flexible joint unit so that the rigid tube units can bend; a bending limit structure is provided in each flexible joint unit to adjust the flexibility of the flexible joint unit, so that the flexible joint unit has a first state and a second state; in the first state, the flexible joint unit is flexible and the rigid tube units are flexibly connected; in the second state, the flexibility of the flexible joint unit is limited, and the rigid tube units are rigidly connected; The electrode pair of the second stimulation electrode is an expandable electrode. In this case, an electrode expansion cavity is provided inside the electrode. The electrode expansion cavity is connected to a filling device and a suction device. The filling device and the suction device are both connected to a controller and receive control of the controller. The controller is configured to: after receiving a pressing instruction for the second stimulation electrode sent by the host computer, control the action of the aforementioned bending limit structure to enable all flexible joint units of the flexible support member to enter the second state; in the second state, based on a preset time period, control the filling device and the suction device to work alternately to alternately fill and suction the electrode expansion cavity with medium, drive the electrode cavity to expand and contract to drive the electrode to periodically press the skin, and during the pressing process, maintain contact between the electrode and the skin, and perform the pressing operation while applying electrical stimulation through the electrode.

[0015] Furthermore, the anti-drop structure includes an ear hook, a movable ear frame, and an ear frame limiting structure. One end of the movable ear frame is connected to the ear hook by a hinge or a rotating shaft, and the other end of the movable ear frame is a free end. The ear hook is C-shaped or D-shaped, including an arc-shaped portion that can be worn between the auricle and the head. The movable ear frame can be flipped relative to the ear hook to move closer to or away from the ear hook. A pressing portion or a vibrating portion is provided on the movable ear frame, and the pressing portion or the vibrating portion is corresponding to the earplug main body and the earplug accessory. When the movable ear frame approaches the ear hook, after the ear frame is limited in movement by the ear frame limiting structure, the pressing portion or the vibrating portion is controlled to work to apply pressure stimulation or vibration stimulation to the earplug main body and / or the earplug accessory, and the pressing or vibration stimulation is performed simultaneously with the application of electrical stimulation through the electrodes. And / or, it also includes at least one extended stimulation accessory installed on the earplug main body, the extended stimulation accessory includes a bracket and a stimulation electrode, one end of the bracket is fixedly connected to the earplug main body or plugged into the earplug main body through an interface, and the other end of the bracket is a free end and is equipped with a stimulation electrode, which is used for transcutaneous microcurrent stimulation signals; when it is necessary to perform current stimulation on the area not covered by the aforementioned earplug main body and earplug accessory, the bracket is adjusted to make the stimulation electrode contact the target position to apply the current stimulation signal.

[0016] The present invention also provides a sleep regulation system, comprising a user terminal, the aforementioned microcurrent electrical stimulation medical device, and a head stimulation component; The user terminal serves as a host computer, and is used to collect the sleep regulation stimulation parameters set by the user, and send the sleep regulation stimulation parameters to the microcurrent electrical stimulation medical device and / or the head stimulation component; The head stimulation assembly includes a head-mounted portion and an electrode adjustment bracket, the electrode adjustment bracket is arranged on the head-mounted portion, and a third stimulation electrode is mounted on the electrode adjustment bracket via a movable connection member, and the third stimulation electrode can be moved on the electrode adjustment bracket via the movable connection member; The third stimulation electrode includes an electrode part and a control capsule. An electrode pair is provided on the electrode part. After the electrode moves to the position of the head area to be stimulated, the control capsule is controlled to make the electrode part protrude and contact the head skin, and output a transcutaneous microcurrent stimulation signal through the head.

[0017] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art, as an example: the transcranial microcurrent electrical stimulation medical device provided by the present invention adopts an earplug-type stimulation electrode to perform transcranial microcurrent stimulation CES, and at the same time forms an extended second stimulation electrode based on the earplug main body, and performs local transcutaneous microcurrent stimulation TENS by contacting other positions of the ear through the second stimulation electrode, and uses the characteristics of the ear to set an anti-detachment structure to limit the position of the earplug, so that the electrode maintains good contact with the skin, thereby providing safe and reliable composite microcurrent stimulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Schematic diagram of the front and outer structure of the external ear.

[0019] Figure 2 This is a functional module structure diagram of the microcurrent electrical stimulation medical device provided in an embodiment of the present invention.

[0020] Figure 3 Schematic diagram of communication between the microcurrent electrical stimulation medical device provided in an embodiment of the present invention and a host computer (a mobile phone in the figure).

[0021] Figure 4 This is a schematic structural diagram of the first stimulation electrode on the earplug body provided by an embodiment of the present invention.

[0022] Figure 5 This is a schematic structural diagram of the second stimulation electrode on the earplug accessory provided by an embodiment of the present invention.

[0023] Figure 6 A schematic structural diagram of a microcurrent electrical stimulation medical device provided with an extended stimulation accessory according to an embodiment of the present invention.

[0024] Figure 7 This is a schematic diagram of the module structure of the sleep control system provided by an embodiment of the present invention.

[0025] Figure 8 A schematic diagram of the head-mounted structure of a head stimulation assembly provided in an embodiment of the present invention.

[0026] Figure 9 A schematic structural diagram of a third stimulation electrode provided in an embodiment of the present invention.

[0027] Description of reference numerals: Device 100, earplug body 110, earplug accessory 120, anti-drop structure 130, extended stimulation accessory 140; earplug head 111, first stimulation electrode 112, metal ring 1121, conductive soft rubber sleeve 1122, expandable capsule 11221; second stimulation electrode 121, electrode portion 1211, electrode expansion capsule 1212; interface 141; Host computer 200; Head-mounted part 300, third stimulation electrode 310, electrode mounting column 311, regulating capsule 312, first capsule 3121, second capsule 3122, electrode part 313. DETAILED DESCRIPTION

[0028] The following is a further detailed description of the microcurrent electrical stimulation medical device and sleep regulation system disclosed in the present invention in conjunction with the accompanying drawings and specific embodiments. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered isolated, and they can be combined with each other to achieve better technical effects. In the drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0029] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not intended to limit the conditions under which the invention can be implemented. Any structural modification, change in proportional relationship, or adjustment of size should fall within the scope of the technical content disclosed in the invention without affecting the efficacy and purpose of the invention. The scope of the preferred embodiments of the present invention includes alternative implementations, in which the functions can be performed in a non-described or discussed order, including performing the functions in a substantially simultaneous manner or in a reverse order according to the functions involved, which should be understood by those skilled in the art of the art to which the embodiments of the present invention belong.

[0030] Technologies, methods, and apparatus known to persons of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such technologies, methods, and apparatus should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not limiting. Therefore, other examples of the exemplary embodiments may have different values.

[0031] In the description of the embodiments of this application, " / " represents "or," and "and / or" is used to describe the association relationship between associated objects, indicating that three possible relationships exist. For example, "A and / or B" represents the following three situations: A and B exist alone, B exists alone, and A and B exist at the same time. In the description of the embodiments of this application, "plurality" means two or more. Example

[0032] The present invention provides a microcurrent electrical stimulation medical device, which combines microcurrent electrical stimulation technology with headphones and arranges stimulation electrodes based on the structure of the headphone earplugs. When in use, the user can control the headphones to apply electrical stimulation and / or play music through a host computer (such as a mobile phone) - specifically, for example, the user can choose to perform microcurrent stimulation treatment, play music, or combine microcurrent stimulation treatment and music playback (that is, combine sound stimulation with electrical stimulation) as needed.

[0033] It should be noted that the prior art has provided some devices that use composite electrical stimulation technology on headphones to stimulate the brain to regulate emotions and promote sleep, but the electrical stimulation method is relatively simple and is prone to poor contact between the electrodes and the skin. Based on this, the present invention proposes an improvement to the headphone structure, utilizing the characteristics of the ear to provide a composite microcurrent stimulation device that can apply transcranial microcurrent stimulation (CES) and local transcutaneous microcurrent stimulation (TENS), and can ensure that the electrodes maintain good contact with the skin. The device can specifically be a headphone.

[0034] See also Figure 2 As shown, the microcurrent electrical stimulation medical device may include a controller, a current generator and an earplug component, and the controller, current generator and earplug are electrically connected to each other.

[0035] The current generator is used to generate a controllable micro-current stimulation signal and transmit it to the electrodes on the earplug.

[0036] The controller is used to receive control instructions from the host computer and control the current generator according to the received control instructions. After the current generator generates a microcurrent stimulation signal with a corresponding waveform, the microcurrent stimulation signal is applied to the human body through the stimulation electrodes on the earplug.

[0037] In this embodiment, the controller and current generator can be separated from the earplug or integrated into the earplug shell. Taking into account the wearing comfort, this embodiment preferably separates the controller and current generator from the earplug. For example, the controller and current generator can be integrated into a separate shell and then electrically connected to the earplug component via a wire. Furthermore, a power supply module (battery) and a power management module can also be set in the shell. In this case, the electrical stimulation component can be powered and managed by the power supply module instead of relying on the host computer (such as a mobile phone).

[0038] In this embodiment, the controller can use Bluetooth technology or WiFi technology to communicate with a host computer (such as a mobile phone). As an example, taking Bluetooth communication as an example, the controller can use a Bluetooth chip as the core, and realize Bluetooth communication with the host computer through the Bluetooth BLE protocol. After the controller receives the control instructions sent by the mobile phone, it can control the operation of the current generator through the I2C interface, IO interface, etc., such as controlling the start, end and electrical stimulation parameters of the electrical stimulation. The electrical stimulation parameters include but are not limited to parameters such as current stimulation time, current stimulation mode, amplitude, frequency and waveform of the current stimulation signal. When a dedicated power supply module and power management module are set, the controller can also collect information from the power management module and feedback battery-related information to the host computer.

[0039] The user can select stimulation modes, adjust parameters, and send instructions through the host computer (such as a mobile phone).

[0040] The earplug component mainly includes an earplug body 110, an earplug accessory 120 and an anti-drop structure 130, see Figure 3 shown.

[0041] The earplug body 110 is worn in the ear canal or on the auricle, depending on whether the earplug is in-ear or semi-in-ear design: if it is an in-ear design, the earplug body is mainly worn in the ear canal; if it is a semi-in-ear design, the earplug body is mainly worn on the auricle.

[0042] A first stimulation electrode is provided on the earplug body 110 , which contacts the auricle and is used to output a transcranial microcurrent stimulation signal, namely a CES signal, through the auricle.

[0043] In specific implementation, a left earplug and a right earplug are respectively provided for the left ear and the right ear, and a left ear electrode and a right ear electrode are respectively provided on the left earplug body and the right earplug body to form the first stimulation electrode, that is, the first stimulation electrode includes a left ear electrode and a right ear electrode.

[0044] During transcranial microcurrent stimulation, the microcurrent stimulation signal emitted by the current generator flows into one of the ear electrodes, passes through the head tissue (including the brain, brainstem, vagus nerve branches, etc.), and then returns from the ear electrode on the other side, forming a closed loop.

[0045] In this embodiment, preferably, the current generator is configured to include a single-stage mode and a double-stage mode.

[0046] In the monopolar mode, one ear electrode acts as the active electrode and the other acts as the reference electrode, with the current flowing from the active electrode to the reference electrode.

[0047] In bipolar mode, the two ear electrodes alternate as positive and negative electrodes based on a preset time period, and the direction of the current is periodically reversed according to the time period, thereby performing bidirectional alternating current stimulation.

[0048] The earplug accessory 120 is provided on the earplug body 110. Specifically, the earplug body 110 is provided with the antihelix crus of the ear (see Figure 1 The earplug accessory 120 should be compliant so that it can adapt to the shape of the antihelix of the ear, and the distal end of the earplug accessory 120 can be clamped in the triangular fossa formed between the antihelical crus.

[0049] The earplug accessory 120 is provided with a second stimulation electrode, which contacts the crus of the antihelix and / or the triangular fossa and is used to output a transcutaneous microcurrent stimulation signal, namely a TENS signal, through the crus of the antihelix and / or the triangular fossa.

[0050] The second stimulation electrodes include paired, spaced-apart electrodes, each forming a positive electrode and a negative electrode of a current loop. The positive electrode and the negative electrode can be located on the left and right sides of a local area to be stimulated (e.g., an acupuncture point). Corresponding to the crus helix and / or triangular fossa, the earbud accessory can be provided with multiple second stimulation electrodes to output transcutaneous microcurrent stimulation signals to the skin in the crus helix and / or triangular fossa regions.

[0051] In specific implementation, the earplug accessories include a left earplug accessory and a right earplug accessory. For any earplug accessory, a pair of antihelix crus stimulation electrodes and a pair of triangular fossa stimulation electrodes can be respectively set corresponding to the antihelix crus and triangular fossa. The antihelix crus stimulation electrode pair is used to perform transcutaneous microcurrent stimulation on the sympathetic acupoint area of ​​the ear, and the triangular fossa stimulation electrode pair is used to perform transcutaneous microcurrent stimulation on the Shenmen acupoint area of ​​the ear.

[0052] In this embodiment, the main structure of the earplug accessory can be made of natural rubber, synthetic rubber, silicone, silicone resin or any other flexible and elastic material. Preferably, in this embodiment, the earplug accessory 120 is made of silicone, which has sufficient compliance to adapt to the shape of the helix.

[0053] The anti-detachment structure 130 is used to fix and limit the earplug to form resistance to the first stimulation electrode and the second stimulation electrode being detached from the ear skin.

[0054] The anti-slip structure 130 is set up by utilizing the characteristics of the ear. Specifically, the earplug accessory 120 may include a flexible soft-gel body, the proximal end of the flexible soft-gel body is connected to the earplug body 110, and the distal end of the flexible soft-gel body is a free end; a flexible protrusion is provided on the side of the distal end of the flexible soft-gel body close to the ear - for example, a soft-gel protrusion, and the shape of the flexible protrusion is adapted to the shape of the triangular fossa between the crus of the antihelix so that the protrusion can be fixed in the triangular fossa to form the aforementioned anti-slip structure 130. At the same time, the flexible protrusion fixed in the triangular fossa can also play an auxiliary positioning role, making it difficult for the device to rotate on the auricle, further playing an anti-slip effect.

[0055] In this embodiment, there may be multiple anti-slip structures. For example, in addition to the above-mentioned anti-slip structure secured by the triangular socket, the anti-slip structure may also include a C-type or D-type ear hook structure. The proximal end of the C-type ear hook structure is connected to the earplug body, and the proximal end extends outward to form the distal end, which is a free end and forms an open loop. The proximal and distal ends of the D-type ear hook structure are both connected to the earplug body, and the proximal and distal ends are connected by a linear connector to form a closed loop.

[0056] For example, a C-shaped earhook structure can include a flexible C-shaped ring that conforms to the contours of the auricle-head junction. This ring can serve as an external ear retaining structure and be suspended and clamped at the auricle-head junction (i.e., behind the ear), thereby retaining the earplug in place. The surface of the earhook structure should be made of a flexible material or covered with a flexible layer to enhance wearing comfort.

[0057] Preferably, the earhook structure and the earplug body are detachably connected. By way of example and not limitation, the earhook structure and the earplug body may be connected using a threaded connection, where the inner surface of the earplug body and the outer surface of the proximal end of the earhook structure are provided with matching threads, and the earhook structure is assembled by screwing the threads on the proximal end of the earhook structure into the earplug body.

[0058] Optionally, the ear hook structure adopts a hollow structure with an inflation pipeline provided therein. A telescopic airbag that becomes arc-shaped after expansion is installed at the distal end of the ear hook structure. When the length of the ear hook structure is insufficient, the length of the ear hook can be extended by the telescopic airbag. Specifically, the telescopic airbag can adopt a corrugated hose with telescopic and expandable properties. One end of the telescopic airbag can be movably connected to the distal end of the ear hook via a universal shaft and connected to a filling device (such as an inflation device) via an inflation pipeline inside the ear hook. The other end of the telescopic airbag can be provided with an air vent, which is used to discharge the gas inside the telescopic airbag. During use, the ear hook structure is clamped behind the ear, and the telescopic airbag is inflated by the filling device. After the telescopic airbag expands, it extends, extending the length of the ear hook and strengthening the connection between the ear hook and the ear.

[0059] In this embodiment, the earplug body may specifically include a housing member, one end of which is provided with components, and the other end is provided with an earplug head for inserting into the ear canal or the concha cavity of the auricle, and the first stimulation electrode is provided on the earplug head.

[0060] The first stimulation electrode includes a metal ring and a conductive soft rubber sleeve.

[0061] The metal ring is located at a position of the earplug head close to the auricle, and the metal ring is electrically connected to the current generator through a first transmission cable. The first microcurrent stimulation signal generated by the current generator is transmitted to the metal ring through the cable.

[0062] The conductive soft rubber sleeve is arranged on the outer periphery of the metal ring and keeps contact with the metal ring. At the same time, the conductive soft rubber sleeve is embedded in the concha cavity and keeps contact with the concha, so as to conduct the first microcurrent stimulation signal to the human body through the auricle.

[0063] See also Figure 4 As shown, an example of the arrangement of the first stimulation electrode 112 on the earplug head 111 for inserting into the auricle when a semi-in-ear design is adopted is shown. The first stimulation electrode 112 includes a metal ring 1121 and a conductive soft rubber sleeve 1122. The metal ring 1121 is electrically connected to the current generator through a transmission cable. The first microcurrent stimulation signal generated by the current generator is transmitted to the metal ring 1121 through the cable, and then transmitted to the conductive soft rubber sleeve 1122 in contact with it. Since the conductive soft rubber sleeve 1122 is embedded in the concha cavity and maintains contact with the concha, it can conduct the current to the human body through the auricle. The conductive soft rubber sleeve is preferably made of conductive silicone material.

[0064] In a preferred embodiment, the first stimulation electrode 1122 may also include a pressure sensor, positioned outside the conductive soft rubber sleeve 1122, for detecting the contact pressure between the conductive soft rubber sleeve 1122 and the surface of the concha. In this case, the conductive soft rubber sleeve 1122 also includes an expandable bladder 11221, which is connected to an inflation device and a suction device. The pressure sensor, inflation device, and suction device are all connected to and controlled by a controller.

[0065] The controller is configured to: receive a pressure signal detected by a pressure sensor, and when the pressure signal is less than a preset first threshold, control the filling device to fill the expandable cavity 11221 of the conductive soft rubber sleeve 1122 with a medium (such as gas), thereby increasing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha to a preset reasonable range through the expansion of the cavity; and when the pressure signal is greater than a preset second threshold, control the suction device to suck the medium from the cavity of the conductive soft rubber sleeve, thereby reducing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha by shrinking the cavity, and controlling the contact pressure to a preset reasonable range to prevent excessive pressure from causing pressure injuries to the skin of the auricle.

[0066] This solution can predict whether the earplug is securely fitted to the auricle. If the earplug tip is likely to come off the auricle (as indicated by a decrease in contact pressure), the conductive soft rubber sleeve 1122 is inflated by gas to increase friction on the contact surface, preventing the earplug from falling off. Furthermore, if the earplug exerts excessive pressure on the auricle, air can be removed to reduce the contact pressure and prevent injury to the auricle.

[0067] In a preferred embodiment, the conductive soft rubber sleeve can cover the Xin acupoint area in the central depression of the concha cavity. When CES is output, the acupoint is auxiliary stimulated by the CES current signal, and the output CES signal is transmitted to the head tissue through the acupoint skin. At this time, the controller can also be configured to: receive a first pressing instruction from the host computer, and based on a preset time period, control the filling device and the suction device to work alternately to alternately fill and suction the expandable bladder of the conductive soft rubber sleeve with a medium, drive the expandable bladder to cyclically expand and contract, and drive the conductive soft rubber sleeve to cyclically press the skin. During the pressing process, the soft rubber sleeve is kept in contact with the skin, so that the pressing operation is performed while applying electrical stimulation.

[0068] In this embodiment, the flexible, soft-gel body of the earplug accessory is preferably a bendable, hollow structure with a lumen within for the passage of a second transmission cable. One end of the second transmission cable is electrically connected to a current generator, and the other end is electrically connected to an electrode (second stimulation electrode) on the surface of the flexible, soft-gel body. The second microcurrent stimulation signal generated by the current generator is transmitted via the second transmission cable to the electrode on the surface of the flexible, soft-gel body.

[0069] Preferably, a tubular flexible support member is provided in the lumen of the flexible soft-gel body, and the flexible support member is used to form a support structure of the flexible soft-gel body while maintaining the bendability of the flexible soft-gel body.

[0070] The flexible support member includes a rigid tube unit and a flexible joint unit. The rigid tube units are connected by the flexible joint unit so that the rigid tube units can be bent; a bending limiting structure is provided corresponding to the flexible joint unit to adjust the flexibility of the flexible joint unit so that the flexible joint unit has a first state and a second state; in the first state, the flexible joint unit is flexible and the rigid tube units are flexibly connected; in the second state, the flexibility of the flexible joint unit is limited and the rigid tube units are rigidly connected.

[0071] See also Figure 5 As shown, the electrode pair of the second stimulation electrode 121 can adopt an expandable electrode. In this case, an electrode expansion sac 1212 is provided on the inner side of the electrode portion 1211 for installing the electrode. The electrode expansion sac 1212 is connected to the filling device and the suction device. The filling device and the suction device are both connected to the controller and receive control of the controller.

[0072] At this time, the controller is configured to: after receiving a pressing instruction for the second stimulation electrode sent by the host computer, control the action of the aforementioned bending limit structure to make all the flexible joint units of the flexible support member enter the second state; in the second state, based on a preset time period, control the filling device and the suction device to work alternately to alternately fill and suck the medium into the electrode expansion cavity, drive the electrode cavity to expand and contract to drive the electrode to periodically press the skin, and during the pressing process, maintain contact between the electrode and the skin, and perform the pressing operation while applying electrical stimulation through the electrode.

[0073] As an example of a typical method but not a limitation, the flexible joint unit can adopt a spring, and the bending limit structure can adopt a retractable pin. The retractable pin can be installed on the inner wall of the rigid tube unit, and a drive motor is provided corresponding to each retractable pin to drive the retractable pin to extend or retract. When the retractable pin is extended, the flexibility of the flexible joint unit is limited, and when the retractable pin is retracted, the flexible joint unit has flexibility. Specifically, when the retractable pin is extended, the pin can reach the adjacent rigid tube unit and enter the pin hole on the rigid tube unit, thereby realizing the rigid connection of the adjacent rigid tube units. Due to the above-mentioned rigid connection, the flexibility of the flexible joint units between the above-mentioned adjacent rigid tube units is limited, and the flexible joint units can no longer bend. When the retractable pin is retracted, the above-mentioned rigid connection is released, and the flexible joint unit can bend under the action of external force.

[0074] The structure of the above-mentioned earplug accessory can not only ensure that the earplug accessory has sufficient flexibility when worn to adapt to the shape changes of the auricle and increase comfort; but also when it is necessary to apply pressure to a local area (such as an acupoint), the flexible support member in the flexible soft rubber body of the earplug accessory is controlled to form a rigid support. At this time, the flexibility of the flexible soft rubber body is limited (the internal flexible support member limits the flexibility of the flexible soft rubber body), thereby providing more support for the pressing operation and improving the pressing effect.

[0075] In another embodiment of this embodiment, the anti-detachment structure may further include an ear hook, a movable ear frame, and an ear frame limiting structure. One end of the movable ear frame is connected to the ear hook via a hinge or a rotating shaft, and the other end of the movable ear frame is a free end. The ear hook may be C-shaped or D-shaped, and the movable ear frame can be flipped relative to the ear hook to move closer to or further away from the ear hook.

[0076] In this case, the movable ear frame can be provided with a pressing portion or a vibrating portion, which is arranged corresponding to the earplug body and earplug accessory. When the movable ear frame is close to the ear hook, after the ear frame movement is restricted by the ear frame limiting structure (such as a magnetic adsorption structure or a buckle), the pressing portion or the vibrating portion is controlled to operate to apply pressure stimulation or vibration stimulation to the earplug body and / or earplug accessory, and the pressing or vibration stimulation is performed simultaneously with the electrical stimulation applied by the electrodes.

[0077] In another embodiment of this embodiment, the microcurrent electrical stimulation medical device may also include at least one extended stimulation accessory installed on the earplug body, and the extended stimulation accessory is used to increase the electrical stimulation area range of the device, which is mainly used to perform current stimulation on areas not covered by the aforementioned earplug body and earplug accessory.

[0078] The extended stimulation accessory may specifically include a bracket and a stimulation electrode. One end of the bracket is fixedly connected (non-detachable) to the earplug body or plugged into the earplug body through an interface (detachable connection). The other end of the bracket is a free end and is equipped with a stimulation electrode. The stimulation electrode is used for transcutaneous microcurrent stimulation signals and has the same specific structure as the second stimulation electrode mentioned above. Figure 6 As shown, an example is given of plugging an extended stimulation accessory 140 onto the earplug body through the interface 141 . After plugging, the extended stimulation accessory 140 is electrically connected to the earplug body 110 .

[0079] When current stimulation is required for areas not covered by the earplug body and earplug accessories, the user can adjust the bracket so that the stimulation electrode contacts the target location to apply the current stimulation signal. In the specific configuration, the bracket preferably adopts a formable bend bracket that can bend under external force and maintain the bent state after the external force is removed. The user can bend the bracket to align the stimulation electrode at the end of the bracket with the skin area to be stimulated, such as the Anmian point area behind the ear, to apply microcurrent stimulation to the Anmian point.

[0080] Preferably, the bracket is an extendable structure, so that the length of the bracket can be extended or shortened, thereby further expanding the stimulation range of the stimulation electrode. When the extended electrical stimulation range is not needed, the user can unplug the extended stimulation accessory from the earplug body and place it in the device storage box provided by the device.

[0081] Another embodiment of the present invention further provides a sleep regulation system. The sleep regulation system includes a user terminal, a micro-current electrical stimulation medical device, and a head stimulation component, wherein the micro-current electrical stimulation medical device and the head stimulation component are sleep regulation execution devices, see Figure 7 shown.

[0082] The user terminal serves as a host computer for collecting sleep regulation stimulation parameters set by the user and transmitting the sleep regulation stimulation parameters to the controller of the microcurrent electrical stimulation medical device and / or the head stimulation component. The microcurrent electrical stimulation medical device and the head stimulation component can each be equipped with a dedicated controller and current generator, or they can share a controller and current generator, without limitation.

[0083] Optionally, the user terminal may include a touchscreen display configured to receive and display user-set sleep regulation stimulation parameters. Furthermore, the touchscreen display may also display the current operating status and operation progress of the microcurrent electrical stimulation device and head stimulation component.

[0084] The microcurrent electrical stimulation medical device includes a controller, a current generator, and an earplug. The earplug includes an earplug body, an earplug accessory, and an anti-detachment structure. The earplug body is worn on the ear canal or auricle. A first stimulation electrode is provided on the earplug body, which contacts the auricle and is used to output a transcranial microcurrent stimulation signal through the auricle. The earplug accessory is formed based on the earplug body extending in the direction of the antihelix crus. It has compliance and can adapt to the shape of the antihelix, and the distal end of the earplug accessory is fixed in the triangular fossa between the antihelix crus. A second stimulation electrode is provided on the earplug accessory, which contacts the antihelix crus and / or the triangular fossa and is used to output a transcutaneous microcurrent stimulation signal through the antihelix crus and / or the triangular fossa. The anti-detachment structure is used to fix and limit the earplug to form resistance to the first and second stimulation electrodes from detaching from the ear skin.

[0085] The head stimulation assembly includes a head-mounted portion and an electrode adjustment bracket, which is arranged on the head-mounted portion. The electrode adjustment bracket is mounted with a third stimulation electrode via a movable connection, and the third stimulation electrode can be moved on the electrode adjustment bracket via the movable connection.

[0086] The headband is used to wear the head stimulation component on the user's head. According to the location of the head acupuncture points related to sleep regulation, the headband may include a top of the head restraint structure and a forehead restraint structure, which are used to respectively set the top of the head stimulation component and the forehead stimulation component. Figure 8 shown.

[0087] The top of the head restraint structure may include a top of the head electrode adjustment bracket, on which a third stimulation electrode (an electrode pair consisting of a positive electrode and a negative electrode) is arranged. The third stimulation electrode can be moved on the top of the head electrode adjustment bracket to align with the acupoint positions in different areas of the top of the head. For example, the third stimulation electrode can be moved to the Baihui acupoint (which can improve sleep) on the top of the head to achieve the application of a transcutaneous microcurrent stimulation signal to the Baihui acupoint area.

[0088] The forehead restraint structure may include a forehead electrode adjustment bracket, on which a third stimulation electrode is provided. The third stimulation electrode can be moved to a position on the forehead electrode adjustment bracket to align with the acupoint positions in different areas of the forehead. For example, the third stimulation electrode can be moved to the Yintang acupoint position on the forehead to apply a transcutaneous microcurrent stimulation signal to the Yintang acupoint area.

[0089] In a preferred embodiment, the electrode adjustment bracket is provided with a slide rail or a slide groove. One end of the third stimulation electrode is mounted on the slide rail or the slide groove of the electrode adjustment bracket via a sliding block (i.e., a movable connector). The sliding block is driven to move on the slide rail or the slide groove, thereby driving the third stimulation electrode to move together. The sliding block and the third stimulation electrode can be driven manually by the user or by a motor, without limitation.

[0090] Preferably, the top electrode adjustment bracket can cover the four Shencong acupoint areas. In this case, multiple third stimulation electrodes can be installed on the bracket to stimulate the four Shencong acupoint areas simultaneously. Also, the forehead electrode adjustment bracket can also cover the temple area. In this case, multiple third stimulation electrodes can be installed on the bracket to stimulate two temples simultaneously. The microcurrent stimulation operation of each third stimulation electrode is independently controlled.

[0091] See also Figure 9 As shown, a typical structure of the third stimulation electrode is illustrated.

[0092] The third stimulation electrode 310 includes an electrode mounting post 311, a control capsule 312, and an electrode portion 313. The electrode portion 313 is provided with an electrode pair. After the electrode portion moves to the position of the head area to be stimulated, the control capsule is controlled to move so that the electrode portion 313 protrudes and contacts the skin of the head, and a transcutaneous microcurrent stimulation signal is output through the head. Specifically, after receiving the control instruction of the host computer, the controller can control the current generator according to the received control instruction, generate a microcurrent stimulation signal of the corresponding waveform through the current generator, and transmit it to the electrodes on the head-mounted part, and apply the current to the human body through the electrodes.

[0093] In a preferred embodiment, the regulating capsule 312 may include an outer first capsule 3121 and a second capsule 3122 located inside the first capsule 3121, and the electrode part 313 is installed at the lower part of the first capsule 312, and the upper part of the electrode part 313 is in contact with the lower part of the second capsule 3122.

[0094] The lower portion of the first capsule 3121 forms a groove. Initially, the electrode portion 313 is located within the groove of the first capsule. To apply electrical stimulation, the first capsule 3121 is filled with a medium (e.g., gas), causing it to expand. Simultaneously, the medium within the first capsule 3121 pushes the electrode portion 313 out of the groove and into contact with the head. The second capsule 3122 within the first capsule 3121 is connected to the filling device and suction device via independent delivery pipelines.

[0095] When pressure is required on the stimulation area, the filling device and the suction device can be controlled to alternately operate based on a preset time period to alternately fill the second capsule 3122 with a medium and suction the medium, thereby driving the second capsule 3122 to expand and contract, thereby driving the electrode portion 313 to periodically press the head. During the pressing process, the electrode portion 313 should maintain contact with the skin, so that the pressing operation is performed while applying electrical stimulation.

[0096] For other technical features, please refer to the description of the previous embodiment and will not be repeated here.

[0097] In the above description, the disclosure of the present invention is not intended to limit itself to these aspects. Rather, within the scope of the intended protection of the present disclosure, the components can be selectively and operationally combined in any number. In addition, terms such as "including", "encompassing" and "having" should be interpreted as inclusive or open by default, rather than exclusive or closed, unless they are explicitly defined to the contrary. All technical, scientific or other terms have the meaning understood by those skilled in the art unless they are defined to the contrary. Common terms found in dictionaries should not be interpreted too idealistically or too impractically in the context of relevant technical documents, unless the present disclosure explicitly defines them as such. Any changes and modifications made by a person of ordinary skill in the field of the present invention based on the above disclosure are within the scope of protection of the claims.

Claims

1. A microcurrent electrical stimulation medical device, comprising a controller and a current generator, characterized in that Also includes: The earplug body is worn on the ear canal or auricle, and is provided with a first stimulation electrode, which contacts the auricle and outputs a transcranial microcurrent stimulation signal through the auricle; The earplug accessory extends from the earplug main body toward the crus of the antihelix, is compliant and adaptable to the shape of the antihelix, and the distal end of the earplug accessory is fixed in the triangular fossa between the crus of the antihelix; the earplug accessory is provided with a second stimulation electrode, which contacts the crus of the antihelix and / or the triangular fossa and is used to output a transcutaneous microcurrent stimulation signal through the crus of the antihelix and / or the triangular fossa; The anti-detachment structure is used to fix and limit the earplug to form resistance to the separation of the first stimulation electrode and the second stimulation electrode from the ear skin.

2. The microcurrent electrical stimulation medical device according to claim 1, characterized in that: A left earplug and a right earplug are respectively provided for the left ear and the right earplug, and a left ear electrode and a right ear electrode are respectively provided on the left earplug body and the right earplug body to form the first stimulation electrode; During transcranial microcurrent stimulation, the microcurrent stimulation signal emitted by the current generator flows into one of the ear electrodes, passes through the head tissue, and then returns from the ear electrode on the other side, forming a closed loop.

3. The microcurrent electrical stimulation medical device according to claim 2, characterized in that: The current generator is configured to include a single-stage mode and a double-stage mode, In the monopolar mode, one ear electrode serves as the active electrode and the other electrode serves as the reference electrode, with the current flowing from the active electrode to the reference electrode; In bipolar mode, the two ear electrodes alternate as positive and negative electrodes based on a preset time period, and the direction of the current is periodically reversed according to the time period.

4. The microcurrent electrical stimulation medical device according to claim 2, characterized in that: The earplug body includes a housing member, one end of which is provided with components, and the other end of which is provided with an earplug head for inserting into the ear canal or the concha cavity of the auricle, and the first stimulation electrode is provided on the earplug head; The first stimulation electrode includes a metal ring and a conductive soft rubber sleeve. The metal ring is located at a position close to the auricle of the earplug head. The metal ring is electrically connected to the current generator through a first transmission cable. The first microcurrent stimulation signal generated by the current generator is transmitted to the metal ring through the cable. The conductive soft rubber sleeve is arranged on the outer periphery of the metal ring and keeps contact with the metal ring. At the same time, the conductive soft rubber sleeve is embedded in the concha cavity and keeps contact with the concha, so as to transmit the first microcurrent stimulation signal to the human body through the auricle.

5. The microcurrent electrical stimulation medical device according to claim 4, characterized in that: The first stimulation electrode further includes a pressure sensor disposed on the outside of the conductive soft rubber sleeve for detecting contact pressure between the conductive soft rubber sleeve and the surface of the concha; the conductive soft rubber sleeve includes an expandable sac cavity, which is connected to a filling device and a suction device; the pressure sensor, the filling device, and the suction device are all connected to a controller and receive control from the controller; The controller is configured to: receive a pressure signal detected by a pressure sensor, and when the pressure signal is less than a preset first threshold, control the filling device to fill the cavity of the conductive soft rubber sleeve with a medium, thereby increasing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha through the expansion of the cavity; and when the pressure signal is greater than a preset second threshold, control the suction device to suck the medium from the cavity of the conductive soft rubber sleeve, thereby reducing the contact pressure between the inner side of the conductive soft rubber sleeve and the metal ring, and between the outer side of the conductive soft rubber sleeve and the concha through the shrinkage of the cavity.

6. The micro-current electrical stimulation medical device according to claim 1, characterized in that: The second stimulation electrodes include electrodes arranged in pairs and spaced apart to form a positive electrode and a negative electrode of a current loop, respectively, the positive electrode and the negative electrode being located on the left and right sides of the local area to be stimulated; Corresponding to the crus helix and / or triangular fossa, a plurality of second stimulation electrodes are provided on the earplug accessory to output transcutaneous microcurrent stimulation signals to the skin of the crus helix and / or triangular fossa area respectively.

7. The micro-current electrical stimulation medical device according to claim 6, characterized in that: The earplug accessory comprises a flexible soft-gel body, the proximal end of which is connected to the earplug body, and the distal end is a free end; a flexible protrusion is provided on the side of the distal end close to the ear, and the shape of the flexible protrusion is adapted to the shape of the triangular fossa between the crus of the antihelix so that the protrusion can be fixed in the triangular fossa, thereby forming the aforementioned anti-drop structure; The flexible soft-gel body is a curved hollow structure, in which a lumen is provided for the passage of a second transmission cable. One end of the second transmission cable is electrically connected to the current generator, and the other end is electrically connected to the electrode on the surface of the flexible soft-gel body; the second microcurrent stimulation signal generated by the current generator is transmitted to the electrode on the surface of the flexible soft-gel body through the second transmission cable.

8. The micro-current electrical stimulation medical device according to claim 7, characterized in that: A tubular flexible support member is provided in the lumen of the flexible soft rubber body, and the flexible support member is used to form a support structure of the flexible soft rubber body while maintaining the flexibility of the flexible soft rubber body; The flexible support member includes a rigid tube unit and a flexible joint unit, and the rigid tube units are connected by the flexible joint unit so that the rigid tube units can bend; a bending limit structure is provided in each flexible joint unit to adjust the flexibility of the flexible joint unit, so that the flexible joint unit has a first state and a second state; in the first state, the flexible joint unit is flexible and the rigid tube units are flexibly connected; in the second state, the flexibility of the flexible joint unit is limited, and the rigid tube units are rigidly connected; The electrode pair of the second stimulation electrode is an expandable electrode. In this case, an electrode expansion cavity is provided inside the electrode. The electrode expansion cavity is connected to a filling device and a suction device. The filling device and the suction device are both connected to a controller and receive control of the controller. The controller is configured to: after receiving a pressing instruction for the second stimulation electrode sent by the host computer, control the action of the aforementioned bending limit structure to enable all flexible joint units of the flexible support member to enter the second state; in the second state, based on a preset time period, control the filling device and the suction device to work alternately to alternately fill and suction the electrode expansion cavity with medium, drive the electrode cavity to expand and contract to drive the electrode to periodically press the skin, and during the pressing process, maintain contact between the electrode and the skin, and perform the pressing operation while applying electrical stimulation through the electrode.

9. The micro-current electrical stimulation medical device according to claim 1, characterized in that: The anti-drop structure includes an ear hook, a movable ear frame, and an ear frame limiting structure. One end of the movable ear frame is connected to the ear hook via a hinge or a rotating shaft, and the other end of the movable ear frame is a free end. The ear hook is C-shaped or D-shaped, including an arc-shaped portion that can be worn between the auricle and the head. The movable ear frame can be flipped relative to the ear hook to move closer to or away from the ear hook. The movable ear frame is provided with a pressing portion or a vibrating portion, and the pressing portion or the vibrating portion is corresponding to the earplug body and the earplug accessory. When the movable ear frame approaches the ear hook, after the ear frame is restricted from moving by the ear frame limiting structure, the pressing portion or the vibrating portion is controlled to operate to apply pressing stimulation or vibrating stimulation to the earplug body and / or the earplug accessory, and the pressing or vibrating stimulation is performed simultaneously with the application of electrical stimulation through the electrodes. And / or, it also includes at least one extended stimulation accessory installed on the earplug main body, the extended stimulation accessory includes a bracket and a stimulation electrode, one end of the bracket is fixedly connected to the earplug main body or plugged into the earplug main body through an interface, and the other end of the bracket is a free end and is equipped with a stimulation electrode, which is used for transcutaneous microcurrent stimulation signals; when it is necessary to perform current stimulation on the area not covered by the aforementioned earplug main body and earplug accessory, the bracket is adjusted to make the stimulation electrode contact the target position to apply the current stimulation signal.

10. A sleep control system, characterized in that: It comprises a user terminal, a micro-current electrical stimulation medical device according to any one of claims 1 to 9, and a head stimulation component; The user terminal serves as a host computer, and is used to collect the sleep regulation stimulation parameters set by the user, and send the sleep regulation stimulation parameters to the microcurrent electrical stimulation medical device and / or the head stimulation component; The head stimulation assembly includes a head-mounted portion and an electrode adjustment bracket, the electrode adjustment bracket is arranged on the head-mounted portion, and a third stimulation electrode is mounted on the electrode adjustment bracket via a movable connection member, and the third stimulation electrode can be moved on the electrode adjustment bracket via the movable connection member; The third stimulation electrode includes an electrode part and a control capsule. An electrode pair is provided on the electrode part. After the electrode moves to the position of the head area to be stimulated, the control capsule is controlled to make the electrode part protrude and contact the head skin, and output a transcutaneous microcurrent stimulation signal through the head.

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