Passive self-powered transdermal electrical stimulation ultra-thin patch system and preparation method thereof

Abstract

This invention belongs to the field of electrode patch technology, specifically disclosing a self-generating transdermal electrostimulation (TES) ultrathin patch system and its preparation method. The system includes, from top to bottom, an outer protective layer, a power generation layer, an energy storage control unit, an electrode layer, and an adhesive layer. The adhesive layer is used to attach the electrode patch to the vagus nerve region of the ear, and the adhesive layer is conductive. The power generation layer uses a PVDF flexible piezoelectric film. When the power generation layer is vibrated, it generates microampere-level AC pulses and transmits these pulses to the energy storage control unit. The energy storage control unit stores energy and releases milliampere-level stimulation pulses to the electrode layer when the voltage reaches a set value. The electrode layer uses two flexible graphene electrodes, which are respectively arranged on both sides of the pressure-reducing groove on the back of the ear, with a gap between them. This technical solution does not require a power source or battery and can generate electricity through vibration, making the electrode patch convenient to use and suitable for long-term wear.

Description

Technical Field

[0001] This invention belongs to the field of electrode patch technology, and particularly relates to a self-generating transdermal electrical stimulation ultrathin patch system and its preparation method. Background Technology

[0002] The vagus nerve, also known as the Arnold nerve, is a sensory branch of the vagus nerve. It is responsible for sensory transmission in the external auditory canal and part of the auricle, and has reflexive connections with visceral functions.

[0003] Because the auricular vagus nerve is the only branch of the vagus nerve on the body surface, it becomes an ideal target for non-invasive vagus nerve stimulation (taVNS). A taVNS stimulator typically consists of an electrical stimulation generator and electrodes. The generator produces the stimulating current, while the electrodes deliver the current to the vagus nerve region in the ear. By electrically stimulating specific areas of the ear, the vagus nerve afferent pathway can be activated. This method has been used to improve insomnia or treat various conditions such as epilepsy, depression, migraines, and inflammatory diseases.

[0004] The auricular branch of the vagus nerve is the only branch of the vagus nerve on the body surface, and it is distributed in the concha cavity and cymba conchae on the outer surface of the auricle.

[0005] The depressive groove is where the auricular branch of the vagus nerve emerges superficially, making it one of the areas on the body surface most easily stimulated by the vagus nerve.

[0006] Existing auricular vagus nerve stimulation (taVNS) devices generally rely on battery power, which has drawbacks such as large size, limited battery life, frequent charging, and unsuitability for long-term non-invasive wear. While a piezoelectric film self-powered solution can address this power supply issue, existing piezoelectric self-powered patches only output weak currents in the microampere (μA) range, insufficient to achieve the effective milliampere (mA) pulses required for nerve stimulation. Furthermore, current technologies are mostly simple stacks of "piezoelectric film + electrode + hydrogel," lacking rectification, boosting, energy storage, and rapid pulse release capabilities, thus failing to achieve effective nerve activation. Summary of the Invention

[0007] The purpose of this invention is to provide a self-generating transdermal electrical stimulation ultrathin patch system and its preparation method, in order to solve the problems of existing ear vagus nerve stimulation devices that generally rely on battery power, resulting in large size, limited battery life, frequent charging, and unsuitability for long-term non-invasive wear.

[0008] To achieve the above objectives, the technical solution of the present invention is as follows: a self-generating transdermal electrostimulation (TEES) ultrathin patch system, comprising, from top to bottom, an outer protective layer, a power generation layer, an energy storage control unit, an electrode layer, and an adhesive layer. The adhesive layer is used to attach the electrode patch to the vagus nerve region of the ear, and the adhesive layer is conductive. The power generation layer uses a PVDF flexible piezoelectric film, which generates microampere-level AC pulses when vibrated and transmits these pulses to the energy storage control unit. The energy storage control unit stores energy and releases milliampere-level stimulation pulses to the electrode layer when the voltage reaches a set value. The electrode layer uses two flexible graphene electrodes, which are used to deliver current to the depressor groove on the back of the ear or the concha, with a gap between the two flexible graphene electrodes. The energy storage control unit includes a passive voltage doubler rectifier module, an energy storage capacitor module, and a pulse triggering and release module connected in sequence. The power generation layer transmits microampere-level AC pulses to the passive voltage doubler rectifier module, which boosts and rectifies the voltage into DC power and then sends the DC power to the energy storage capacitor module for energy storage. The pulse triggering and release module can release milliampere-level stimulation pulses to the electrode layer after the voltage reaches a set value.

[0009] Furthermore, the passive voltage doubler rectifier module adopts a passive two- or three-times voltage doubler rectifier module; the energy storage capacitor module adopts a low-dropout Schottky diode and a surface-mount capacitor or a low-dropout Schottky diode and a thin-film capacitor; the pulse triggering and release module is used to determine whether to turn on the circuit to release the pulse based on the voltage of the energy storage capacitor module.

[0010] Furthermore, when the patch is used to stimulate the pressure-reducing groove behind the ear, the flexible graphene electrode is designed as a planar arc-shaped structure, and the arc-shaped structure matches the curvature of both sides of the pressure-reducing groove behind the ear.

[0011] Furthermore, when the patch is used to stimulate the concha cavity, the two flexible graphene electrodes are a large circular electrode and a small circular electrode, which are concentrically arranged.

[0012] Furthermore, when the patch is used to stimulate the concha cavity, the two flexible graphene electrodes are two circular electrodes, which are arranged opposite each other.

[0013] Furthermore, the patch system is used to stimulate the upper 1 / 3 of the pressure-reducing groove on the back of the ear.

[0014] Furthermore, the total thickness of the patch system is ≤1mm. When the patch system is used to stimulate the pressure-reducing groove on the back of the ear, it adopts a strip-shaped structure, which includes rectangles and ellipses. The long axis of the rectangle or the major axis of the ellipse is 20mm-25mm, and the width of the rectangle or the minor axis of the ellipse is 8mm-10mm. When the patch system is used to stimulate the concha, it adopts a circular shape with a diameter of 10mm-15mm. The thickness of the flexible graphene electrode is ≤0.05mm.

[0015] Furthermore, the surface of the outer protective layer is provided with auxiliary lines, which are aligned with the two flexible graphene electrodes and match the shape of the flexible graphene electrodes.

[0016] Furthermore, the power generation layer, energy storage control unit, and electrode layer are fixed together with conductive adhesive.

[0017] A method for preparing a self-generating transdermal electrical stimulation (TES) ultrathin patch system, comprising the following steps: Material preparation: Prepare the outer protective layer, power generation layer, energy storage control unit, electrode layer and adhesive layer in sequence; the energy storage control unit is installed on the substrate and all parts are made conductive; The core components are connected as follows: the electrode layer and the power generation layer are located on both sides of the energy storage control unit; the two flexible graphene electrodes of the electrode layer are connected to the positive and negative electrodes of the energy storage control unit respectively, and the two flexible graphene electrodes are fixed on the lower side of the substrate; the PVDF flexible piezoelectric film is connected to the passive voltage doubler rectifier module, and the passive voltage doubler rectifier module is fixed on the upper side of the substrate. Connecting the overall structure: The outer protective layer is attached to the upper side of the power generation layer, and the adhesive layer is attached to the lower side of the electrode layer, thus forming an overall patch system.

[0018] The working principle of this technical solution is as follows: After removing the protective film from the adhesive layer, the electrode patch is attached to the upper 1 / 3 stimulation area of ​​the pressure-reducing groove on the back of the ear or the concha cavity via a conductive hydrogel adhesive layer. During the attachment process, the auxiliary lines on the outer protective layer are used to align the patch with the upper 1 / 3 stimulation area of ​​the pressure-reducing groove on the back of the ear or the interior of the concha cavity. During walking, exercise, and vascular pulsation, the power generation layer vibrates (micro-motion), generating microampere-level AC pulses. These pulses are transmitted to a passive voltage multiplier rectifier module, which boosts and rectifies them into direct current (DC), which is then sent to an energy storage capacitor module for energy storage. When the voltage reaches the trigger threshold, the pulse triggering and release module activates the circuit to release the pulse, forming a milliampere-level stimulation pulse. The pulse is focused through the electrode layer (two flexible graphene electrodes, serving as positive and negative electrodes respectively) onto the upper 1 / 3 stimulation area of ​​the pressure-reducing groove on the back of the ear or the concha cavity, achieving non-invasive neuromodulation.

[0019] The beneficial effects of this technical solution are as follows: ① This technical solution does not require a power source or battery; it generates its own electricity through vibration, making the patch easy to use and suitable for prolonged wear. Furthermore, by incorporating an energy storage control unit, it stores the current generated by the micro-movements, which can then be released as nerve-stimulating pulses.

[0020] ② The flexible graphene electrode in this technical solution is extremely thin, almost imperceptible when placed behind the ear, and inconspicuous. Furthermore, the low interfacial impedance of the graphene electrode results in higher stimulation efficiency. There is no metal corrosion or ion dissolution, and no risk of skin allergies.

[0021] ③ The flexible graphene electrode used to stimulate the pressure-reducing groove behind the ear in this technical solution adopts an arc-shaped structure, which can adapt to the physiological curvature of the pressure-reducing groove behind the ear.

[0022] ④ In this technical solution, auxiliary lines are set on the surface of the outer protective layer, which makes it easy to attach the flexible graphene electrode to the accurate position. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of a self-generating transdermal electrical stimulation ultrathin patch system according to the present invention; Figure 2 A schematic diagram of the pressure-reducing groove behind the ear; Figure 3 This is a diagram of the first arc-shaped structure of two flexible graphene electrodes used to stimulate the pressure-reducing groove behind the ear. Figure 4 This is a diagram of the second arc-shaped structure of two flexible graphene electrodes used to stimulate the pressure-reducing groove behind the ear; Figure 5 This is a diagram illustrating how a rectangular patch is attached behind the ear. Figure 6 This is a diagram illustrating the application of an oval-shaped patch behind the ear. Figure 7 A schematic diagram of the structure of the concha; Figure 8 This is a schematic diagram of the first structure of two flexible graphene electrodes used to stimulate the concha cavity; Figure 9 This is a schematic diagram of the second structure of two flexible graphene electrodes used to stimulate the concha cavity; Figure 10 This is a diagram illustrating the application of the patch inside the concha. Figure 11 A flowchart of the patch panel system; Figure 12 This is a schematic diagram of a surface mount system. Figure 13 The circuit schematic of a passive voltage doubler rectifier module (voltage doubler); Figure 14 This is the circuit schematic of the energy storage capacitor module; Figure 15 The circuit schematic for monitoring voltage and triggering the Zener diode; Figure 16 This is a circuit diagram for pulse release. Detailed Implementation

[0024] The following detailed description illustrates the specific implementation method: The reference numerals in the accompanying drawings include: outer protective layer 1, power generation layer 2, energy storage control unit 3, electrode layer 4, adhesive layer 5, pressure reduction groove behind the ear 6, auxiliary line 7, flexible graphene electrode 8, concha cavity 9, large circular electrode 10, small circular electrode 11, and circular electrode 12.

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example

[0026] The basics are as follows: Figure 1-16 As shown: A self-generating transdermal electrical stimulation ultrathin patch system, such as Figure 5 , 6 As shown in Figures 1 and 10, this is used to stimulate the pressure-reducing groove 6 on the back of the ear or the concha 9. In this embodiment, stimulating the pressure-reducing groove 6 on the back of the ear specifically involves stimulating the upper 1 / 3 of the stimulation area of ​​the pressure-reducing groove 6 on the back of the ear. Figure 1 As shown, the patch system includes, from top to bottom, an outer protective layer 1 (specifically a medical waterproof protective film), a power generation layer 2, an energy storage and control unit 3, an electrode layer 4, and an adhesive layer 5. The adhesive layer 5 is used to attach the electrode patch to the vagus nerve region of the ear (i.e., the depressor groove 6 on the back of the ear or the concha 9). The adhesive layer 5 is conductive and is a conductive hydrogel adhesive layer. A protective film is attached to the bottom surface of the conductive hydrogel adhesive layer, and the patch can be attached by peeling off the protective film.

[0027] The power generation layer 2 uses a PVDF flexible piezoelectric film. When vibrated, the power generation layer 2 generates microampere-level AC pulses (0.1μA–3μA microcurrent) and transmits these pulses to the energy storage control unit 3. The energy storage control unit 3 stores energy and, when the voltage reaches a set value, releases milliampere-level stimulation pulses (0.5mA–2.4mA) to the electrode layer 4. The electrode layer 4 uses two flexible graphene electrodes 8, which are used to deliver current to the pressure relief groove 6 behind the ear or the concha 9. The power generation layer 2, the energy storage control unit 3, and the electrode layer 4 are fixed together with conductive adhesive. A gap (0.5mm–2mm) is left between the two flexible graphene electrodes 8 to avoid contact.

[0028] When the patch is used to stimulate the pressure-reducing groove 6 on the back of the ear, the flexible graphene electrode 8 is designed as a planar arc-shaped structure, which matches the curvature of the upper 1 / 3 stimulation area on both sides of the pressure-reducing groove 6 on the back of the ear. Figure 3 As shown, the arc-shaped structure is a curved structure that roughly matches the trend of the auricular posterior pressure depression groove 6; as Figure 4 As shown, the arc-shaped structure is a semi-circular structure that encompasses the pressure-reducing groove 6 on the back of the ear.

[0029] When the patch is used to stimulate the concha 9, such as Figure 8 As shown, the two flexible graphene electrodes 8 are a large circular ring electrode 10 and a small circular ring electrode 11, respectively, and the large circular ring electrode 10 and the small circular ring electrode 11 are arranged concentrically. Alternatively, as... Figure 9 As shown, the two flexible graphene electrodes 8 are two circular electrodes 12, which are arranged opposite each other and located on both sides of the concha cavity 9.

[0030] The surface of the outer protective layer 1 is provided with auxiliary lines 7, which are directly opposite to the two flexible graphene electrodes 8 and match the shape of the flexible graphene electrodes 8. The auxiliary lines 7 are located at the center of the corresponding flexible graphene electrodes 8.

[0031] The total thickness of the patch system is ≤1mm. When used to stimulate the pressure-reducing groove 6 on the back of the ear, the patch system adopts a long strip structure, including rectangular and elliptical shapes. The long axis of the rectangle or the major axis of the ellipse is 20mm–25mm, and the width of the rectangle or the minor axis of the ellipse is 8mm–10mm. When used to stimulate the concha 9, the patch system adopts a circular shape, with a diameter of 10mm–15mm. The thickness of the flexible graphene electrode is ≤0.05mm, with low interfacial impedance and no metal ion dissolution. In this embodiment, the concha 9 is selected as circular, and the pressure-reducing groove 6 on the back of the ear is selected as elliptical.

[0032] The energy storage control unit 3 includes a passive voltage doubler rectifier module, an energy storage capacitor module, and a pulse triggering and release module connected in sequence. The power generation layer 2 transmits microampere-level AC pulses to the passive voltage doubler rectifier module, which boosts and rectifies the voltage into DC power and then sends the DC power to the energy storage capacitor module for energy storage. The pulse triggering and release module can release milliampere-level stimulation pulses to the two flexible graphene electrodes 8 after the voltage reaches a set value.

[0033] The passive voltage doubler rectifier module uses diodes and capacitors. In this embodiment, it achieves a 2-voltage doubler, therefore using two diodes (D1, D2) and two capacitors (C1, C2), as follows: Figure 13 As shown. The energy storage capacitor module uses a low-dropout Schottky diode (D3) and a surface-mount capacitor (C3), or a low-dropout Schottky diode (D3) and a film capacitor (C3). The thickness of the surface-mount or film capacitor is ≤0.3mm. One side of the surface-mount or film capacitor is connected to the passive voltage doubler rectifier module, and the other side is connected to the low-dropout Schottky diode (providing a low-impedance discharge path). The pulse triggering and release module uses a Zener diode (ZD1) and a surface-mount miniature SCR thyristor. The Zener diode (ZD1) is connected to the surface-mount miniature SCR thyristor and the surface-mount or film capacitor (C3) respectively (e.g., Figure 15 (As shown). The Zener diode (ZD1) sets a precise trigger threshold (by selecting diodes with different Zener values). When the voltage of the energy storage capacitor module is less than the trigger threshold, the Zener diode is cut off, there is no signal at the SCR gate, and the circuit is broken. When the voltage of the energy storage capacitor module is greater than or equal to the trigger threshold, the Zener diode breaks down and conducts, providing a trigger current to the SCR gate, the SCR is fully turned on, and the energy storage capacitor module releases a pulse to the flexible graphene electrode (e.g., ...). Figure 16 (As shown). After the voltage drops, the SCR self-holds off and cycles through reset.

[0034] The specific implementation process is as follows: Remove the protective film and attach the electrode patch to the upper 1 / 3 stimulation area of ​​the pressure-reducing groove 6 on the back of the ear using the conductive hydrogel adhesive layer. During the attachment process, use the auxiliary line 7 on the outer protective layer 1 to align the patch with the upper 1 / 3 stimulation area of ​​the pressure-reducing groove on the back of the ear, ensuring that the two flexible graphene electrodes 8 are positioned on either side of the stimulation area. During head movements, facial movements, and vascular pulsation, the power generation layer 2 vibrates (micro-motion), generating microampere-level AC pulses. These pulses are transmitted to the passive voltage multiplier rectifier module, which boosts and rectifies them into direct current (DC), which is then sent to the energy storage capacitor module for energy storage. When the voltage reaches the trigger threshold, the pulse triggering and release module activates the circuit to release the pulse, forming a milliampere-level stimulation pulse. The pulse is focused through the electrode layer 4 (two flexible graphene electrodes 8, serving as positive and negative electrodes respectively) onto the upper 1 / 3 stimulation area of ​​the pressure-reducing groove 6 on the back of the ear, achieving non-invasive neuromodulation.

[0035] Here is an example: The PVDF piezoelectric film outputs a microcurrent of 0.1μA–3μA under the micro-movement of the human body, and the voltage is boosted to 1.5V–3V by the passive voltage multiplier rectifier module; the energy storage capacitor module continuously accumulates charge under the microcurrent, realizing energy storage over time; when the voltage reaches the trigger threshold, the pulse trigger and release module discharges rapidly, forming a peak pulse current of 0.5mA–2.4mA, which meets the stimulation threshold of the vagus nerve (0.39mA–0.66mA); the bilateral flexible graphene electrodes form a targeted electric field, with a small area and high current density, to achieve stable nerve activation with lower energy.

[0036] Here is an example of a selection: The outer protective layer 1 uses a 0.025mm medical-grade PU film; the PVDF flexible piezoelectric film uses an ultra-thin polarized PVDF piezoelectric film with double-sided copper / silver plated flexible electrodes, with a thickness of approximately 0.02mm; an ultra-thin flexible FPC substrate (specifically, an ultra-thin PI polyimide single-sided adhesive FPC with a thickness of 0.1mm) is used to support the passive voltage doubler rectifier module, surface mount capacitors, low-dropout Schottky diodes, Zener diodes, and surface mount miniature SCR thyristors. All components are laid out in a flat layout and cannot be stacked. The passive voltage doubler rectifier module (diodes and capacitors), surface mount capacitors, low-dropout Schottky diodes, Zener diodes, and surface mount miniature SCR thyristors are all made of 0402 ultra-thin low-profile surface mount, with a thickness of approximately 0.22mm. The flexible graphene electrode 8 has a thickness of approximately 0.04mm. The conductive hydrogel adhesive layer uses medical-grade ultrathin conductive hydrogel with a thickness of about 0.06 mm, and the total thickness is 0.025+0.02+0.1+0.22+0.04+0.06=0.465 mm. Example

[0037] A method for preparing a self-generating transdermal electrical stimulation ultrathin patch system, used to prepare the self-generating transdermal electrical stimulation ultrathin patch system of Example 1, includes the following steps: Material preparation: Prepare the outer protective layer 1, power generation layer 2, energy storage control unit 3, electrode layer 4 and adhesive layer 5 in sequence; wherein the energy storage control unit 3 is installed on the substrate and makes each part conductive.

[0038] The core components are connected as follows: the electrode layer 4 and the power generation layer 2 are located on both sides of the energy storage control unit 3; the two flexible graphene electrodes 8 of the electrode layer 4 are connected to the positive and negative electrodes of the energy storage control unit 3 respectively, and the two flexible graphene electrodes 8 are fixed on the lower side of the substrate; the PVDF flexible piezoelectric film is connected to the passive voltage doubler rectifier module, and the passive voltage doubler rectifier module is fixed on the upper side of the substrate.

[0039] Connecting the overall structure: The outer protective layer 1 is attached to the upper side of the power generation layer 2, and the adhesive layer 5 is attached to the lower side of the electrode layer 4, thus forming an overall patch system.

[0040] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0041] The above descriptions are merely embodiments of the present invention. Commonly known structures and characteristics are not described in detail here. Those skilled in the art are aware of all common technical knowledge in the field prior to the application date or priority date, are aware of all existing technologies in that field, and have the ability to apply conventional experimental methods prior to that date. Those skilled in the art can, under the guidance of this application, improve and implement this solution in combination with their own capabilities. Some typical known structures or methods should not be obstacles for those skilled in the art to implement this application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the structure of the present invention. These should also be considered within the scope of protection of the present invention, and will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system, characterized by: The device comprises, from top to bottom, an outer protective layer (1), a power generation layer (2), an energy storage control unit (3), an electrode layer (4), and an adhesive layer (5). The adhesive layer (5) is used to attach the electrode patch to the vagus nerve region of the ear and is conductive. The power generation layer (2) is made of PVDF flexible piezoelectric film. When the power generation layer (2) is vibrated, it generates microampere-level AC pulse current and transmits the microampere-level AC pulse current to the energy storage control unit (3). The energy storage control unit (3) is capable of storing energy and, when the voltage reaches a set value, releases milliampere-level stimulation pulses to the electrode layer (4). The electrode layer (4) uses two flexible graphene electrodes (8). The two flexible graphene electrodes (8) are used to transmit current to the pressure relief groove (6) on the back of the ear or the concha (9). There is a gap between the two flexible graphene electrodes (8). The energy storage control unit (3) includes a passive voltage doubler rectifier module, an energy storage capacitor module, and a pulse triggering and release module connected in sequence. The power generation layer (2) transmits microampere-level AC pulses to the passive voltage doubler rectifier module, which boosts and rectifies the voltage into DC power and then transmits the DC power to the energy storage capacitor module for energy storage. The pulse triggering and release module can release milliampere-level stimulation pulses to the electrode layer (4) after the voltage reaches a set value.

2. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 1, wherein: The passive voltage doubler rectifier module adopts a passive two- or three-times voltage doubler rectifier module; the energy storage capacitor module adopts a low-dropout Schottky diode and a surface-mount capacitor or a low-dropout Schottky diode and a thin-film capacitor; the pulse triggering and release module is used to determine whether to turn on the circuit to release the pulse based on the voltage of the energy storage capacitor module.

3. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 1, wherein: When the patch is used to stimulate the pressure relief groove (6) on the back of the ear, the flexible graphene electrode (8) is set as a planar arc structure, and the arc structure matches the curvature on both sides of the pressure relief groove (6) on the back of the ear.

4. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 1, wherein: When the patch is used to stimulate the concha cavity (9), the two flexible graphene electrodes (8) are a large circular electrode (10) and a small circular electrode (11), which are concentrically arranged.

5. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 1, wherein: When the patch is used to stimulate the concha cavity (9), the two flexible graphene electrodes (8) are two circular electrodes (12), and the two circular electrodes (12) are arranged opposite each other.

6. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 3, wherein: The patch system is used to stimulate the upper 1 / 3 stimulation area of ​​the pressure-reducing groove (6) on the back of the ear.

7. A passive, self-powered, transdermal electrical stimulation ultra-thin patch system according to claim 1, wherein: The total thickness of the patch system is ≤1mm. When the patch system is used to stimulate the pressure-reducing groove (6) on the back of the ear, it adopts a long strip structure, which includes rectangles and ellipses. The long axis of the rectangle or the major axis of the ellipse is 20mm-25mm, and the width of the rectangle or the minor axis of the ellipse is 8mm-10mm. When the patch system is used to stimulate the concha (9), it adopts a circle with a diameter of 10mm-15mm. The thickness of the flexible graphene electrode (8) is ≤0.05mm.

8. The self-generating transdermal electrical stimulation ultrathin patch system according to claim 1, characterized in that: The surface of the outer protective layer (1) is provided with auxiliary lines (7), which are directly opposite the two flexible graphene electrodes (8) and match the shape of the flexible graphene electrodes (8).

9. The self-generating transdermal electrical stimulation ultrathin patch system according to claim 1, characterized in that: The power generation layer (2), energy storage control unit (3) and electrode layer (4) are fixed together by conductive adhesive.

10. A method for preparing a self-generating transdermal electrical stimulation ultrathin patch system, used to prepare the self-generating transdermal electrical stimulation ultrathin patch system as described in claim 1, characterized in that: Includes the following steps: Material preparation: Prepare the outer protective layer (1), power generation layer (2), energy storage control unit (3), electrode layer (4) and adhesive layer (5) in sequence; wherein the energy storage control unit (3) is installed on the substrate and makes each part conductive; The core components are connected as follows: the electrode layer (4) and the power generation layer (2) are located on both sides of the energy storage control unit (3); the two flexible graphene electrodes (8) of the electrode layer (4) are connected to the positive and negative electrodes of the energy storage control unit (3) respectively, and the two flexible graphene electrodes (8) are fixed on the lower side of the substrate; the PVDF flexible piezoelectric film is connected to the passive voltage doubler rectifier module, and the passive voltage doubler rectifier module is fixed on the upper side of the substrate; Connect the overall structure: attach the outer protective layer (1) to the upper side of the power generation layer (2) and attach the adhesive layer (5) to the lower side of the electrode layer (4) to form an overall patch system.

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