Appliance for transdermal delivery of active ingredients

Abstract

The invention discloses an appliance for transdermal delivery of active ingredients, which comprises a main body shell and a head shell, the head shell is provided with an inner electrode and an outer electrode which are coaxially arranged, the inner electrode comprises a conductive base layer and conductive salient points which are distributed on the surface of the conductive base layer in an array, and an insulating layer covers a non-working area and exposes the tops of the salient points as electrode points. And the main body shell adopts a modular nested structure, so that the assembly efficiency is improved. The inner electrode structure realizes electric field focusing through the array design of the conductive salient points, the working voltage requirement is reduced, and the energy loss is reduced; the integrated design eliminates interface contact resistance and improves the current transmission efficiency; the design of the opening of the insulating layer accurately controls the electric field action range and enhances the space targeting; the design of a transition layer and a groove is omitted, the manufacturing complexity and cost are reduced, and the device is suitable for efficient transdermal delivery of active ingredients and can be expanded to the fields of beauty, chronic disease treatment and the like.

Description

Technical Field

[0001] The present invention relates to the technical field of bioelectrodes, and particularly to an apparatus for transdermal delivery of active ingredients. Background Art

[0002] Electroporation is a very unique physical phenomenon of cells. Under the action of an electric field, especially when the field strength exceeds a certain threshold, the dense structure composed of keratinocytes and the intercellular lipid layer undergoes physical rearrangement to form transient pores, achieving efficient transdermal delivery of drugs / ingredients. With the proposal and continuous development of the drill-wall theoretical model of the skin electroporation mechanism, electroporation technology has been widely applied to transdermal drug delivery, skin beauty and other application scenarios.

[0003] However, the high-voltage pulses of traditional electroporation can cause some living cells to die due to the damage of the cell membrane, and the cell lethality rate is relatively high. The high lethality rate of exogenously introduced molecules will affect the efficacy of skin beauty and transdermal drug delivery. At the same time, the high-voltage pulses will cause the capillaries in the dermis layer to dilate under the electric field stimulation, resulting in erythema and even slight swelling, affecting the body feeling of the beautifier. Moreover, the existing bipolar electroporation system needs to rely on a voltage gradient of more than 100V to generate an effective electric field strength, but the energy ratio actually acting on the target tissue is only 10%-20%. A large amount of energy is wasted in the form of heat loss or non-specific ionization, resulting in high device power consumption, poor battery life, and continuous high-voltage output may cause safety risks such as skin burns. In addition, the traditional electrode configuration adopts single-point or bipolar planar arrangement, and its electric field distribution shows a diffuse characteristic. Non-target areas (such as subcutaneous nerves, blood vessels) are easily exposed to high-intensity electric fields, resulting in a narrow treatment window. Experimental data show that in the conventional two-electrode system at an energy density of 1.5 J / cm 2 , the electric field strength on the skin surface is only 30 V / cm, and the field strength attenuation is exponentially related to the tissue depth.

[0004] Chinese patent publication number CN115637225A discloses a microelectrode structure and a preparation method thereof, which includes: a substrate layer; a transition layer located on one side of the substrate layer, and a groove running through the transition layer; an electrode layer located on the side of the transition layer away from the substrate layer, the electrode layer covers the bottom and sidewalls of the groove, and covers the surface of the transition layer away from the substrate layer; an insulating layer located in the groove and located on the side of the electrode layer in the groove away from the substrate layer, the insulating layer exposes part of the electrode layer located on the side of the transition layer away from the substrate layer to form a plurality of microelectrode units; and a plurality of microelectrode units are arranged in an array. Although the microelectrode structure also forms a plurality of microelectrode units to realize electroporation technology, it has the advantages of strong inertness, good stability and good biocompatibility. However, it adopts a multi-layer composite structure (including: substrate layer, transition layer, electrode layer, insulating layer), and the structure is complex, which makes the preparation process cumbersome and the cost high. In addition, the interface of the multi-layer material may have poor adhesion or stress concentration problems, which affects the long-term stability and thus affects the life of the product using the structure.

[0005] Therefore, how to overcome the above-mentioned defects has become an important issue to be solved urgently by those skilled in the art. Summary of the invention

[0006] In order to solve the problems of low energy utilization efficiency, insufficient spatial targeting, limited penetration depth, complex structure, complex assembly, cumbersome preparation process and high cost of existing bioelectrodes, the present invention provides a device for transdermal delivery of active ingredients. To achieve the above purpose, the present invention adopts the following technical solutions:

[0007] An apparatus for transdermal delivery of active ingredients, comprising: a main body shell 1 and a head shell 2 connected to the main body shell 1, the head shell 2 is provided with an inner electrode 3 and an outer electrode 4, the inner electrode 3 and the outer electrode 4 have opposite polarities; a PCB board 5 is installed in the main body shell 1, the PCB board 5 is provided with a positive electrode connection terminal 51 and a negative electrode connection terminal 52; the inner electrode 3 and the outer electrode 4 are electrically connected to the positive electrode connection terminal 51 / negative electrode connection terminal 52 according to their own polarity requirements;

[0008] Wherein, the inner electrode 3 comprises:

[0009] Conductive base layer 31;

[0010] A plurality of conductive bumps 32 are formed on one side of the conductive base layer 31;

[0011] An insulating layer 33 covering a side surface of the conductive base layer 31 with the conductive bumps 32;

[0012] An opening 34 is formed on the insulating layer 33 to expose a portion of the conductive bump 32 .

[0013] Preferably, the inner electrode 3 is disposed in the middle of the top surface of the head housing 2, the outer electrode 4 is annularly disposed around the outside of the inner electrode 3, and an insulating layer 22 is provided between the inner electrode 3 and the outer electrode 4.

[0014] Preferably, the head housing 2 includes: an outer electrode bracket 21 positioned and installed above the main housing 1 through a first positioning structure, the outer electrode 4 limitedly installed in the outer electrode bracket 21, the insulating layer 22 between the inner and outer electrodes limitedly installed in the outer electrode 4, an inner electrode bracket 23 embedded in the insulating layer 22 between the inner and outer electrodes, and a housing portion 24 connected to the outer periphery of the outer electrode bracket 21. The inner electrode 3 is installed on the top surface of the inner electrode bracket 23; the first positioning structure includes: a positioning notch 61 provided on the main housing 1 and a positioning tooth 62 protruding downward from the bottom surface of the support housing portion 21 and snapped into the positioning notch 61.

[0015] Preferably, the main housing 1 includes a bottom housing portion 11 and a mounting housing portion 12 detachably connected to the top of the bottom housing portion 11 by a thread; a PCB board 5 and a battery 13 for supplying power to the PCB board 5 are installed inside the bottom housing portion 11, a charging port 14 for charging the battery 13 is provided at the bottom, and a first through hole 15 for a wire to pass through is provided at the top; the mounting housing portion 16 is screwed and connected with the head housing 2.

[0016] Preferably, the outer electrode bracket 21 is made of an insulating material, and a second through hole 232 for a wire to pass through is provided on the inner electrode bracket 23.

[0017] Preferably, a plurality of conductive bumps 32 are distributed in a circular array; the conductive bumps 32 and the conductive base layer 31 are integrally formed.

[0018] Preferably, a part of each conductive bump 32 exposed outside the insulating layer 33 serves as an electrode point 321, and the surface of the exposed part of the conductive bump 32 is a flat surface.

[0019] Preferably, a plurality of conductive bumps 32 are distributed in a circular array, the conductive bumps 32 are truncated conical, and the opening 34 is a circular opening.

[0020] Preferably, the distance between two adjacent conductive bumps 32 is 1 - 999 um, the height range of each conductive bump 32 is 10 - 200 um, and the diameter range of each opening 34 is 10 - 500 um.

[0021] Preferably, the inner electrode 3 further includes: a gold plating layer 35 formed on the electrode point 321.

[0022] Compared with the prior art, the beneficial effects of the present invention are:

[0023] 1. The conductive bumps of the inner electrode in this case are designed in an array, focusing the electric field on local tiny electrode points, enabling the appliance applying this inner electrode to focus the electric field on local tiny electrode points. Compared with existing beauty devices or medical appliances with large planar electrodes, it has a higher current density, can reduce the working voltage requirement. On the one hand, it is convenient to achieve a strong electric field intensity even at a lower working voltage, thus being able to open the stratum corneum to achieve electroporation, ensuring the delivery of active ingredients, and can also reduce the voltage so that users will not experience discomfort such as skin stinging and erythema, improving the user experience. On the other hand, due to the electric field focusing, it can reduce the diffusion loss of energy to non-target areas, thereby reducing the overall thermal effect, so that the introduced active substances will not be inactivated due to excessive heat.

[0024] 2. The inner electrode in this case is arranged in the middle of the top surface of the head housing, and the outer electrode surrounds it annularly on the outside. This layout helps to form a more uniform and focused electric field. The electric field is radially distributed from the inner electrode to the outer electrode, making the distribution of the electric field intensity more uniform within the target delivery area, and at the same time being able to focus more effectively on the area where the active ingredients need to be delivered, improving the efficiency of transdermal delivery. This layout of the inner electrode and the outer electrode makes the device structure more compact and reasonable, facilitating portability and use. In addition, during actual application, since the inner electrode and the outer electrode are in the same plane and in contact with the human body, a circuit can also be formed when the user uses it alone, which is convenient.

[0025] 3. In this case, a first positioning structure is formed by setting a positioning notch on the top surface of the installation shell part of the main housing and a positioning tooth on the bottom surface of the outer electrode bracket that cooperates with it, so as to accurately position the installation position between the head housing and the main housing, reduce the installation error, and the installation method is simple and direct, facilitating quick installation and disassembly, with accurate positioning and convenient installation. The outer electrode bracket, the inner and outer electrode insulation layer, the outer electrode and the inner electrode bracket are installed in a nested manner, and each component is closely fitted through a stepped part and nested layer by layer to form a stable structural system. On the one hand, it can improve the overall strength of the product and prevent the internal components from loosening due to external forces; on the other hand, it helps to reduce vibration and noise, enhancing the user experience, and is conducive to applying the appliance to beauty and medical scenarios. The elastic annular protrusion on the inner wall of the outer electrode cooperates with the annular groove of the inner electrode bracket, and it can be fixed only by pressing without additional fasteners, greatly reducing the assembly difficulty and further simplifying the installation process. The inner electrode wire is connected to the PCB board through the second through hole and the first through hole, and the outer electrode wire is directly connected through the first through hole, facilitating the connection of the wire to the inner electrode and the outer electrode, with reasonable wiring, reducing the interference and crossing between wires, and avoiding signal interference. Brief Description of the Drawings

[0026] Figure 1 It is a three-dimensional structural schematic diagram of the appliance in the first embodiment of this case.

[0027] Figure 2 It is a schematic exploded view of the device in the first embodiment of this case.

[0028] Figure 3 It is a schematic structural diagram of the inner electrode in the first embodiment of this case.

[0029] Figure 4 It is Figure 3 An enlarged view of part A of

[0030] Figure 5 It is Figure 3 A schematic structural diagram under the A-A cross-sectional view of

[0031] Figure 6 It is Figure 5 An enlarged view of part B of

[0032] Figure 7 It is a schematic exploded view of the head shell in the first embodiment of this case.

[0033] Figure 8 It is a schematic cross-sectional structure diagram of the device in the first embodiment of this case.

[0034] Figure 9 It is a schematic structural diagram of the device in the first embodiment of this case with part of the shell hidden.

[0035] Figure 10 It is a schematic diagram of the connection of the PCB board, battery, inner electrode (required to be the positive electrode), and outer electrode (required to be the negative electrode) in the first embodiment of this case.

[0036] Figure 11 It is a schematic structural diagram of the inner electrode bracket in the first embodiment of this case.

[0037] Figure 12 It is in the second embodiment of this case Figure 6 A schematic diagram of adding a gold plating layer on the basis of Specific implementation mode

[0038] The features of the present invention and other related features are further described in detail through the following embodiments for the understanding of those skilled in the same industry:

[0039] Embodiment 1

[0040] As Figures 1 to 11 shown, an apparatus for transdermal delivery of active ingredients includes: a main body shell 1 and a head shell 2 detachably screwed onto the main body shell 1 by a thread. The head shell 2 is provided with an inner electrode 3 and an outer electrode 4, and the polarities of the inner electrode 3 and the outer electrode 4 are opposite; a PCB board 5 is installed inside the main body shell 1, and the PCB board 5 is used to control the internal circuit to output a specific electric field to the inner electrode / outer electrode;

[0041] The PCB board 5 is provided with a positive connection end 51 and a negative connection end 52. The inner electrode 3 and the outer electrode 4 are electrically connected to the positive connection end 51 / negative connection end 52 according to their own polarity requirements; for example, when the outer electrode requires a positive pole and the inner electrode requires a negative pole, the positive connection end 51 is electrically connected to the outer electrode through a wire, and the negative connection end 52 is electrically connected to the inner electrode through a wire, so as to output a specific electric field to the inner electrode / outer electrode. During specific implementation, the inner electrode 3 is centered, and the outer electrode 4 surrounds it annularly, forming an axisymmetric electric field, naturally avoiding the edge effect, and the energy distribution is more uniform.

[0042] Among them, the inner electrode 3 includes: a conductive base layer 31, a plurality of conductive bumps 32, and an insulating layer 33; the conductive base layer 31 is made of a conductive metal or a conductive semiconductor material. A plurality of arrayed conductive bumps 32 are formed on one surface of the conductive base layer 31. The conductive bumps 32 are manufactured by electrochemical etching or laser engraving on the conductive base layer, and the conductive base layer 31 and the conductive bumps 32 are integrally formed. The insulating layer 33 is covered on one surface of the conductive base layer 31 with conductive bumps 32 by a pressing method, covering both the surface of the conductive base layer 31 with conductive bumps 32 and the surface of the conductive bumps 32, and then through a polishing process, the insulating layer of the conductive bumps 32 is polished off to expose a partial conductive structure of the conductive bumps 32 as the electrode points 321 in contact with the human skin. Among them, an opening 34 for exposing a part of the conductive bumps 32 is formed on the insulating layer 33. A plurality of conductive bumps are arrayed.

[0043] As described above, through the array design of the conductive bumps of the inner electrode in this case, the electric field is focused on local tiny electrode points, so that the appliance applying this inner electrode can focus the electric field on local tiny electrode points. Compared with the existing beauty instruments or medical appliances with large planar electrodes, it has a higher current density, can reduce the working voltage requirement. On the one hand, it is convenient to achieve a strong electric field intensity even at a lower working voltage, so as to open the stratum corneum to achieve electroporation, ensure the delivery of active ingredients, and can also reduce the voltage so that users will not cause discomfort such as skin tingling and erythema, improving the user experience; on the other hand, due to the electric field focusing, the diffusion loss of energy to non-target areas can be reduced, thereby reducing the overall thermal effect, so that the introduced active substances will not be inactivated due to excessive heat.

[0044] As Figure 1 shown, as a specific implementation manner, the inner electrode 3 is arranged in the middle of the top surface of the head shell 2, the outer electrode 4 surrounds the outside of the inner electrode 3 annularly, and an inner and outer electrode insulating layer 22 is provided between the inner electrode 3 and the outer electrode 4.

[0045] As described above, in this case, the inner electrode is disposed in the middle of the top surface of the head housing, and the outer electrode is annularly surrounded outside it. This layout helps to form a more uniform and focused electric field. The electric field is radially distributed from the inner electrode to the outer electrode, making the electric field intensity more evenly distributed within the target delivery area (such as the skin surface), and at the same time being able to more effectively focus on the area where the active ingredient needs to be delivered, improving the efficiency of transdermal delivery. This layout of the inner and outer electrodes makes the device structure more compact and reasonable, facilitating portability and use. The setting of the insulating layer 22 between the inner and outer electrodes is to isolate the two electrodes, ensuring that the current is only transmitted in the predetermined circuit while avoiding the short-circuit risk caused by the contact or dielectric breakdown of the two electrodes. In addition, during actual application, since the inner and outer electrodes are in the same plane and in contact with the human body, a circuit can be formed even when the user uses it alone, which is convenient to use.

[0046] As Figures 1 - 2 , Figures 8 - 10 shown, as a specific implementation manner, the main body housing 1 includes a bottom shell portion 11 and a mounting shell portion 12 that is detachably screwed to the top of the bottom shell portion 11. Specifically, the outer side of the top of the bottom shell portion 11 is provided with threads, and the inner side of the bottom of the mounting shell portion 12 is provided with threads. A waterproof sealing ring 17 is installed between the bottom shell portion 11 and the mounting shell portion 12; the PCB board 5 is longitudinally installed inside the bottom shell portion 11, and a battery 13 for supplying power to the PCB board 5 is connected to the PCB board 5. The battery can be a lithium battery. A charging port 14 for charging the battery 13 is opened at the bottom of the bottom shell portion 11, and a first through hole 15 for the wire to pass through is opened at the top; specifically, the shape of the PCB board 5 is a rectangular plate body with two protrusions formed at the edges, and the positive connection end 51 and the negative connection end 52 are installed at these two protrusion positions. The mounting shell portion 16 is further screwed and connected to the head housing 2 through the threads on the outer side of the top.

[0047] As described above, the main body housing 1 is detachably screwed together by the bottom shell portion 11 and the mounting shell portion 12 to facilitate the maintenance and replacement of internal components. A waterproof sealing ring 17 is installed between the bottom shell portion 11 and the mounting shell portion 12, which can effectively prevent external impurities such as moisture and dust from entering the inside of the housing, protecting the internal electronic components from damage and improving the reliability and stability of the product. A charging port 14 is opened at the bottom of the bottom shell portion 11, and the user can conveniently charge the battery 13 without disassembling the entire device, improving the convenience of use. A first through hole 15 is opened at the top of the bottom shell portion 11, facilitating the wire on the PCB board 5 to pass through and connect to the inner and outer electrodes, ensuring a reasonable wire layout and also contributing to improving the overall structural compactness of the product.

[0048] As Figures 7 - 8As shown in the figure, the head housing 2 sequentially includes, from outside to inside: an outer housing portion 24, an outer electrode bracket 21, an outer electrode 4, an inner and outer electrode insulating layer 22, an inner electrode bracket 23, and an inner electrode 3. The outer electrode bracket 21 is positioned and installed above the main housing 1. A positioning notch 61 is formed by recessing the top surface of the installation housing portion 12 of the main housing 1. A positioning tooth 62 is formed by protruding downward from the bottom surface of the outer electrode bracket 21, and the shape of the positioning tooth 62 is matched with the positioning notch 61. The positioning notch 61 and the positioning tooth 62 form a first positioning structure. During actual installation, the positioning tooth 62 is snapped into the positioning notch 61 to achieve positioning and installation. The outer electrode bracket 21 forms a stepped portion on the inner side for the outer electrode 4 to sink into for installation. The outer electrode 4 also forms a stepped portion on the inner side for the inner and outer electrode insulating layer 22 to sink into for installation. The outer electrode 4 is in a ring shape. The inner electrode bracket 23 is embedded in the inner and outer electrode insulating layer 22, and the inner electrode 3 is installed on the top surface of the inner electrode bracket 23. The outer peripheral of the outer electrode bracket 21 is covered with the outer housing portion 24, and the outer housing portion 24 is provided with an internal thread for screwing and connecting with the installation housing portion 16. During specific implementation, one or more annular positioning grooves 231 are formed by recessing the inner wall of the inner electrode bracket 23, and one or more rings of annular protrusions 221 corresponding to the annular positioning grooves 231 are installed by protruding from the inner wall of the inner and outer electrode insulating layer 22. The annular protrusions 221 are elastic annular elastic protrusions, so that when installing, the inner electrode bracket 23 can be embedded into the inner and outer electrode insulating layer 22 by pressing it downward. In addition, the outer electrode bracket 21 is made of insulating material. A second through hole 232 for the wire to pass through is formed in the inner electrode bracket 23. The wire connecting the positive / negative extreme of the connection circuit board can sequentially pass through the first through hole and be electrically connected to the inner electrode through the first through hole. The wire connected to the outer electrode can be directly electrically connected to the positive / negative extreme of the circuit board through the first through hole.

[0049] As described above, in this case, a first positioning structure is formed by providing a positioning notch on the top surface of the installation shell part of the main housing and a positioning tooth on the bottom surface of the outer electrode bracket that cooperates with it, so as to accurately position the installation position between the head housing and the main housing, reduce installation errors, and the installation method is simple and direct, facilitating quick installation and disassembly, with accurate positioning and convenient installation. The outer electrode bracket, the inner and outer electrode insulating layer, the outer electrode and the inner electrode bracket are installed in a nested manner, and each component is tightly fitted through a stepped part and nested layer by layer to form a stable structural system. On the one hand, it can improve the overall strength of the product and prevent the internal components from loosening due to external forces; on the other hand, it helps to reduce vibration and noise, enhance the user experience, and is beneficial to applying the appliance to beauty and medical scenarios. The elastic annular protrusion on the inner wall of the outer electrode cooperates with the annular groove of the inner electrode bracket, and it can be fixed only by pressing without additional fasteners, greatly reducing the assembly difficulty and further simplifying the installation process. The inner electrode wire is connected to the PCB board through the second through hole and the first through hole, and the outer electrode wire is directly connected through the first through hole, facilitating the connection of the wire to the inner electrode and the outer electrode, with reasonable wiring, reducing interference and crossing between wires, and avoiding signal interference. In addition, the outer electrode bracket 21 is made of insulating material and can be used as an external insulating layer to isolate the outer electrode from the outside, further ensuring electrical safety.

[0050] As Figures 3 - 6 shown, as a specific implementation manner, a plurality of conductive bumps 32 are distributed in a circular array; the conductive bumps 32 are integrally formed with the conductive base layer 31. Specifically, the conductive bumps 32 are in the shape of a truncated cone, and the opening 34 is a circular opening. In addition, by directly forming the conductive bumps on the base layer, the design of the transition layer and the groove is omitted, reducing the manufacturing complexity and cost. During specific implementation, the conductive bumps and the circular opening form a vertical-radial composite electric field, so that the vertical component acts on the stratum corneum, and a high current density (>1A / cm 2 ) is used to quickly open the lipid barrier; the radial component guides the electric field to diffuse subcutaneously through the gradient field strength on the side wall of the cone, and the penetration depth can reach 5-6 mm (only 2-3 mm for traditional planar electrodes).

[0051] As described above, the circular array arrangement makes the electric field superposition region of adjacent conductive bumps 32 symmetrically distributed in a ring shape, optimizing the electric field focusing effect and avoiding the generation of local hot spots. The conductive base layer 31 and the conductive bumps 32 are integrally formed, eliminating the interface contact resistance of the traditional multi-layer structure, reducing the overall impedance, improving the current transmission efficiency, and reducing the ineffective loss of energy during transmission. The conductive bumps 32 are designed in a truncated conical shape, forming a geometric structure with a gradually narrowing shape, so that the electric field gradually increases from the bottom to the top, realizing the gradient distribution of the electric field. On the one hand, it can avoid the local high electric field strength of the traditional sharp conical electrode (which is likely to cause cell damage), and on the other hand, it can enhance the electric field strength of deep tissues through geometric focusing. The design of the circular opening can utilize the fact that the circular edge has no sharp corners, which matches the geometric symmetry of the truncated cone, and can evenly disperse the thermal stress or mechanical stress between the insulating layer and the bumps, improving the structural durability.

[0052] As Figure 6 shown, as a specific implementation manner, a part of each conductive bump 32 exposed outside the insulating layer 33 serves as an electrode point 321, and the surface of the exposed part of the conductive bump 32 is a plane. In this way, the electrode point 21 exposed by the conductive bump 32 through the polishing process has a planar structure. On the one hand, the pressure distribution is uniform when contacting the skin, avoiding local current concentration; on the other hand, it forces the current to vertically penetrate the skin, reducing lateral diffusion and improving the focusing efficiency.

[0053] As a preferred implementation manner, the distance between adjacent two conductive bumps 32 is 1 - 999 um, preferably 20 - 600 um. The height range of each conductive bump is 10 - 200 um, preferably 100 - 200 um; the diameter range of each opening 34 is 10 - 500 um, preferably 50 - 200 um. In this way, by limiting the distance between adjacent two conductive bumps and the diameter of the opening (i.e., the top diameter of the exposed conductive bump), the number of conductive bumps that can be integrated in the same unit area far exceeds that of the large electrodes in the prior art. When the same voltage or current is applied, the current can be more evenly distributed on each conductive bump, effectively increasing the current density. The design of the size ranges of 1 - 999 um, 10 - 200 um, and 10 - 500 um can flexibly adapt to different cell sizes or experimental requirements.

[0054] In summary, the main housing and the head housing of the apparatus in this case are detachably screwed together by threads, which facilitates the cleaning, maintenance, and component replacement of the device. Through the array design of the conductive bumps of the inner electrode in this case, the electric field is focused on local tiny electrode points, enabling the apparatus using this inner electrode to focus the electric field on local tiny electrode points. Compared with existing beauty devices or medical instruments with large planar electrodes, it has a higher current density, can reduce the working voltage requirement. On the one hand, it is convenient to achieve a strong electric field intensity even at a lower working voltage. Since it can open the stratum corneum to achieve electroporation and ensure the delivery of active ingredients, it can also reduce the voltage so that users will not experience discomfort such as skin stinging and erythema, improving the user experience. On the other hand, due to the electric field focusing, it can reduce the diffusion loss of energy to non-target areas, thereby reducing the overall thermal effect, so that the active substances to be introduced into the human body will not be inactivated due to excessive heat. The opening 34 of the insulating layer 3 is designed to accurately control the range of the electric field action, avoid the exposure of non-target tissues, and enhance the spatial targeting. And in this case, a specific electric field is output to the inner electrode and the outer electrode through the PCB board, achieving precise control of the electric field intensity and distribution, which helps to optimize the transdermal delivery effect and ensure that the active ingredients can be efficiently and accurately delivered to the target tissue. The PCB board in this case is provided with a positive connection terminal and a negative connection terminal. The design that the inner electrode and the outer electrode are electrically connected to the positive connection terminal / negative connection terminal with the opposite polarity according to their own polarities ensures the correct connection of the circuit and guarantees the normal operation and stability of the device.

[0055] Embodiment 2

[0056] As Figure 12 shown, on the basis of Embodiment 1, the inner electrode 3 in Embodiment 2 further includes: a gold plating layer 35 formed on the electrode point 321. In this way, the compatibility between the electrode and the skin can be improved.

[0057] In summary, the apparatus in this case adopts a coaxial dual-electrode layout (central inner electrode + annular outer electrode) to form an axisymmetric electric field, naturally avoiding the edge effect and improving the uniformity of the electric field distribution. Through its innovative design, the inner electrode has achieved multiple beneficial effects such as electric field focusing, improving energy utilization efficiency, accurately controlling the range of the electric field action, simplifying the preparation process, and improving the compatibility between the electrode and the skin. These beneficial effects together enhance the performance of the apparatus and the user experience, providing an efficient, safe, and convenient solution for the transdermal delivery of active ingredients, which can be extended to fields such as beauty and chronic disease treatment.

[0058] As described above, what this case protects is an apparatus for the transdermal delivery of active ingredients. All technical solutions that are the same as or similar to this case should be regarded as falling within the protection scope of this case.

Claims

1. An apparatus for transdermal delivery of an active ingredient, characterized in that, Comprising: A main body housing (1) and a head housing (2) connected to the main body housing (1). An inner electrode (3) and an outer electrode (4) are provided on the head housing (2), and the polarities of the inner electrode (3) and the outer electrode (4) are opposite; a PCB board (5) is installed inside the main body housing (1), and the PCB board (5) is provided with a positive connection terminal (51) and a negative connection terminal (52); the inner electrode (3) and the outer electrode (4) are electrically connected to the positive connection terminal (51) / negative connection terminal (52) according to their own polarity requirements. Wherein, the inner electrode (3) comprises: A conductive base layer (31); A plurality of conductive bumps (32) formed on one side surface of the conductive base layer (31); An insulating layer (33) covering one side surface of the conductive base layer (31) with the conductive bumps (32); Wherein, an opening (34) for exposing a part of the conductive bumps (32) is formed on the insulating layer (33).

2. The apparatus according to claim 1, wherein The inner electrode (3) is arranged in the middle of the top surface of the head housing (2), the outer electrode (4) annularly surrounds the outside of the inner electrode (3), and an inner and outer electrode insulating layer (22) is provided between the inner electrode (3) and the outer electrode (4).

3. The appliance according to claim 2, characterized in that, The head housing (2) comprises an outer electrode bracket (21) positioned and installed above the main body housing (1) through a first positioning structure, the outer electrode (4) limitedly installed inside the outer electrode bracket (21), the inner and outer electrode insulating layer (22) limitedly installed inside the outer electrode (4), an inner electrode bracket (23) embedded and installed inside the outer electrode insulating layer (22), and a housing part (24) connected to the outer periphery of the outer electrode bracket (21). The inner electrode (3) is installed on the top surface of the inner electrode bracket (23); the first positioning structure comprises a positioning notch (61) provided on the main body housing (1) and a positioning tooth (62) protruding downward from the bottom surface of the support housing part (21) and snapped into the positioning notch (61).

4. The appliance according to claim 3, characterized in that, The main body housing (1) comprises a bottom housing part (11) and an installation housing part (12) detachably connected to the top of the bottom housing part (11) by threads; the bottom housing part (11) internally installs the PCB board (5) and a battery (13) for supplying power to the PCB board (5), a charging port (14) is opened at the bottom for charging the battery (13), and a first through hole (15) for a wire to pass through is opened at the top; the installation housing part (16) is screwed and connected with the head housing (2).

5. The appliance according to any one of claims 3-4, characterized in that, The outer electrode bracket (21) is made of an insulating material, and a second through hole (232) for a wire to pass through is opened on the inner electrode bracket (23).

6. The apparatus according to claim 1, wherein The plurality of conductive bumps (32) are distributed in a circular array; the conductive bumps (32) are integrally formed with the conductive base layer (31).

7. The appliance according to claim 1, characterized in that, A part of each conductive bump (32) exposed outside the insulating layer (33) serves as an electrode point (321), and the surface of the exposed part of the conductive bump (32) is a plane.

8. The appliance according to claim 6 or 7, characterized in that, The plurality of conductive bumps (32) are distributed in a circular array, the conductive bumps (32) are frustum-conical, and the opening (34) is a circular opening.

9. The appliance according to claim 1, characterized in that, The pitch between two adjacent conductive bumps (32) is 1 - 999 μm, the height range of each conductive bump (32) is 10 - 200 μm, and the diameter range of each opening (34) is 10 - 500 μm.

10. The appliance according to claim 1 or 7, characterized in that, The inner electrode (3) further includes: a gold plating layer (35) formed on the electrode point (321).

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