Electrode array device, control method thereof, electrode probe and electrode plate

Abstract

The invention relates to the technical field of medical instruments, in particular to an electrode array, a control method thereof and an electrode probe, and the electrode array comprises a first electrode array and a second electrode array of which inner and outer rings are independently regulated and controlled; the second electrode array is located on the inner ring, and the first electrode array is located on the outer ring. The first electrode array comprises a plurality of first surface electrodes with alternately arranged positive and negative electrodes; and the second electrode array comprises a plurality of second surface electrodes with alternately arranged positive and negative electrodes. The electrode array provided by the invention can effectively improve the uniformity of electric field distribution, remarkably reduce the risk of electric breakdown, improve the voltage resistance and ensure the safety and stability of treatment through the electrode layout of independent regulation and control of the inner and outer rings and the alternative discharge design.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrode array device and its control method, as well as an electrode probe and electrode sheet. Background Technology

[0002] Electroporation is a novel physical therapy technique that delivers electrical pulses to the skin via surface electrodes attached to the skin, achieving non-invasive treatment. The principle behind electroporation is to use high-voltage pulses to create nanopores in the cell membrane. When the pulse energy exceeds the cell's tolerance, the cell initiates apoptosis without damaging the skin's extracellular matrix structure, making it a non-invasive treatment that does not cause additional trauma (called irreversible electroporation, IRE). Furthermore, when the pulse energy is within the cell's tolerance range, the cell membrane perforation caused by the pulse can be reversed, and the protein connections between the skin barrier can be temporarily disrupted (called reversible electroporation, RE). This temporary perforation and barrier disruption can promote the penetration and absorption of drugs / active ingredients within the skin.

[0003] Electrode arrays are the direct actuators of electroporation treatment systems, delivering electrical pulse energy to the target tissue. Currently, point-like or needle-like electrode arrays are commonly used clinically. The electric field generated by these arrays exhibits a rapid decay from the surface outwards, resulting in poor uniformity and directly limiting the efficacy and safety of electroporation treatment. Summary of the Invention

[0004] To address the problem of poor electric field uniformity in existing electrode arrays, this invention provides an electrode array that improves electric field uniformity while ensuring safety by introducing a first electrode array and a second electrode array with independently adjustable inner and outer rings. This solves the problem of poor electric field uniformity in existing electrode arrays.

[0005] The technical solution adopted by this invention to solve its technical problem is: An electrode array device includes a first electrode array and a second electrode array with independently adjustable inner and outer rings; the second electrode array is located in the inner ring, and the first electrode array is located in the outer ring; the first electrode array includes a plurality of first surface electrodes with alternating positive and negative electrodes; the second electrode array includes a plurality of second surface electrodes with alternating positive and negative electrodes.

[0006] Optionally, at least one first surface electrode with a positive attribute in the first electrode array serves as the positive terminal of the first electrode array, at least one first surface electrode with a negative attribute in the first electrode array serves as the negative terminal of the first electrode array, at least one second surface electrode with a positive attribute in the second electrode array serves as the positive terminal of the second electrode array, and at least one second surface electrode with a negative attribute in the second electrode array serves as the negative terminal of the second electrode array.

[0007] Optionally, all the first-side electrodes with positive properties in the first electrode array are connected in parallel to form the positive terminal of the first electrode array, all the first-side electrodes with negative properties in the first electrode array are connected in parallel to form the negative terminal of the first electrode array, all the second-side electrodes with positive properties in the second electrode array are connected in parallel to form the positive terminal of the second electrode array, and all the second-side electrodes with negative properties in the second electrode array are connected in parallel to form the negative terminal of the second electrode array. The electrode array device has at least 4 electrode terminals used as external voltage input.

[0008] Optionally, both the first electrode array and the second electrode array are centrally symmetrical.

[0009] Optionally, the first electrode array and the second electrode array are concentric circle structures.

[0010] Optionally, the outer edges of a plurality of first surface electrodes form an outer ring; the outer edges of a plurality of second surface electrodes form an inner ring; the outer diameter of the inner ring is 10-20 mm; and the outer diameter of the outer ring is 40-50 mm.

[0011] Optionally, the number of the first surface electrodes and the number of the second surface electrodes are both even numbers, the first electrode array includes at least two pairs of the first surface electrodes, and the second electrode array includes at least one pair of the second surface electrodes.

[0012] Optionally, the distance between adjacent first surface electrodes, the distance between adjacent second surface electrodes, and the distance between adjacent first surface electrodes and second surface electrodes are all greater than or equal to 1 mm and less than 5 mm.

[0013] Optionally, both the first and second surface electrodes have rounded corners at their edges; the first surface electrode is a fan-ring structure, with the top edge of the fan-ring structure having a rounded corner and a radius not greater than 0.5 mm, and the side edge of the fan-ring structure having a rounded corner and a radius not greater than 1 mm; the second surface electrode is a fan-shaped structure, with the top edge of the fan-shaped structure having a rounded corner and a radius not greater than 0.5 mm, and the side edge of the fan-shaped structure having a rounded corner and a radius not greater than 1 mm.

[0014] Optionally, the conductivity of both the first surface electrode and the second surface electrode is not less than 1×10⁻⁶. 6 S / m.

[0015] Another object of the present invention is to provide a control method for the electrode array device as described above, comprising: independently setting parameters and discharging control for the first electrode array and the second electrode array respectively.

[0016] Optionally, discharging control of the first electrode array and the second electrode array respectively includes applying electrical pulses to the first electrode array and the second electrode array in a synchronous or asynchronous manner.

[0017] Optionally, discharging control of the first electrode array and the second electrode array respectively includes applying electrical pulses to the first electrode array and the second electrode array asynchronously.

[0018] Optionally, the first electrode array includes a plurality of first surface electrodes with alternating positive and negative electrodes; the second electrode array includes a plurality of second surface electrodes with alternating positive and negative electrodes; at least one first surface electrode with a positive attribute is connected to the positive terminal of the first electrode array, and at least one first surface electrode with a negative attribute is connected to the negative terminal of the first electrode array; a first electric field closed loop is formed through the positive and negative terminals of the first electrode array; at least one second surface electrode with a positive attribute is connected to the positive terminal of the second electrode array, and at least one second surface electrode with a negative attribute is connected to the negative terminal of the second electrode array; a second electric field closed loop is formed through the positive and negative terminals of the second electrode array; discharge control of the first electrode array and the second electrode array includes: independently regulating the electrical pulse signals in the first electric field closed loop and the second electric field closed loop respectively.

[0019] Optionally, at least one first surface electrode connected as a positive terminal is uniformly distributed in the first electrode array, and at least one first surface electrode connected as a negative terminal is uniformly distributed in the first electrode array. And / or, at least one second surface electrode connected as a positive terminal is uniformly distributed in the second electrode array, and at least one second surface electrode connected as a negative terminal is uniformly distributed in the second electrode array.

[0020] Optionally, the first electrode array includes a plurality of first surface electrodes with alternating positive and negative electrodes; the second electrode array includes a plurality of second surface electrodes with alternating positive and negative electrodes; all the first surface electrodes with positive properties are connected in parallel to form the positive terminal of the first electrode array, and all the first surface electrodes with negative properties are connected in parallel to form the negative terminal of the first electrode array; a first electric field closed loop is formed through the positive and negative terminals of the first electrode array; all the second surface electrodes with positive properties are connected in parallel to form the positive terminal of the second electrode array, and all the second surface electrodes with negative properties are connected in parallel to form the negative terminal of the second electrode array; a second electric field closed loop is formed through the positive and negative terminals of the second electrode array; discharge control of the first electrode array and the second electrode array includes: independently regulating the electrical pulse signals in the first electric field closed loop and the second electric field closed loop respectively.

[0021] Another object of the present invention is to provide an electrode probe, including a probe housing and an electrode array device; the electrode array device is disposed on the top surface of the probe housing and is used to contact human cell tissue; the electrode array device includes a first electrode array and a second electrode array with independently adjustable inner and outer rings; the second electrode array is located in the inner ring and the first electrode array is located in the outer ring; the first electrode array includes a plurality of first surface electrodes with alternating positive and negative electrodes; the second electrode array includes a plurality of second surface electrodes with alternating positive and negative electrodes.

[0022] Optionally, the first electrode array and the second electrode array are both centrally symmetrical in shape, or the first electrode array and the second electrode array are concentric circle structures.

[0023] Optionally, the probe housing includes a pressure-applying component and a handheld end, the handheld end and the pressure-applying component forming an internal cavity for accommodating a voltage control board; the pressure-applying component has a top surface for fixing the electrode array device; all first-side electrodes of positive polarity in the first electrode array are connected in parallel to form the positive terminal of the first electrode array, all first-side electrodes of negative polarity in the first electrode array are connected in parallel to form the negative terminal of the first electrode array, all second-side electrodes of positive polarity in the second electrode array are connected in parallel to form the positive terminal of the second electrode array, all second-side electrodes of negative polarity in the second electrode array are connected in parallel to form the negative terminal of the second electrode array, and the electrode array device has at least two pairs of positive and negative terminals, both of which are electrically connected to the voltage control board.

[0024] Optionally, the first and second electrodes on the electrode array device each have a convex surface for contacting human cell tissue, and the convex surface has a smooth outer edge and protrudes beyond the top surface.

[0025] Optionally, the height difference between the convex surfaces of the first and second surface electrodes and the top surface of the probe housing is no greater than 0.5 mm.

[0026] Optionally, the outer edges of a plurality of first surface electrodes form an outer ring; the outer edges of a plurality of second surface electrodes form an inner ring; the outer diameter of the inner ring is 10-20 mm; and the outer diameter of the outer ring is 40-50 mm.

[0027] Optionally, the number of the first surface electrodes and the number of the second surface electrodes are both even numbers, the first electrode array includes at least two pairs of the first surface electrodes, and the second electrode array includes at least one pair of the second surface electrodes.

[0028] Optionally, the distance between adjacent first surface electrodes, the distance between adjacent second surface electrodes, and the distance between adjacent first surface electrodes and second surface electrodes are all greater than or equal to 1 mm and less than 5 mm.

[0029] Optionally, both the first and second surface electrodes have rounded corners at their edges; the first surface electrode is a fan-ring structure, with the top edge of the fan-ring structure having a rounded corner and a radius not greater than 0.5 mm, and the side edge of the fan-ring structure having a rounded corner and a radius not greater than 1 mm; the second surface electrode is a fan-shaped structure, with the top edge of the fan-shaped structure having a rounded corner and a radius not greater than 0.5 mm, and the side edge of the fan-shaped structure having a rounded corner and a radius not greater than 1 mm.

[0030] Optionally, an insulating material is filled between adjacent surface electrodes, and / or, an insulating material is filled between adjacent surface electrodes, and the Shore hardness of the insulating material is not greater than 80.

[0031] Optionally, the dielectric strength of the insulating material is not less than 3kV / mm.

[0032] Optionally, the dielectric constant of the probe housing is not less than 3.5, and / or the conductivity of both the first and second surface electrodes is not less than 1×10⁻⁶. 6 S / m.

[0033] Another object of the present invention is to provide an electrode sheet comprising a stacked substrate layer, an adhesive layer, and a conductive layer, wherein the conductive layer comprises at least one set of electrode array devices, each set of electrode array devices comprising a first electrode array and a second electrode array with independently adjustable inner and outer rings; the second electrode array is located in the inner ring, and the first electrode array is located in the outer ring; the first electrode array comprises a plurality of first surface electrodes with alternating positive and negative electrodes; the second electrode array comprises a plurality of second surface electrodes with alternating positive and negative electrodes.

[0034] Optionally, in each group of electrode array devices, all the first-side electrodes with positive properties in the first electrode array are connected in parallel to form the positive terminal of the first electrode array, all the first-side electrodes with negative properties in the first electrode array are connected in parallel to form the negative terminal of the first electrode array, all the second-side electrodes with positive properties in the second electrode array are connected in parallel to form the positive terminal of the second electrode array, and all the second-side electrodes with negative properties in the second electrode array are connected in parallel to form the negative terminal of the second electrode array. Each group of electrode array devices has at least 4 electrode terminals used as external voltage inputs. The positive terminals of the first electrode arrays of all groups of electrode array devices are connected together to form the first positive terminal of the electrode sheet, the negative terminals of the first electrode arrays of all groups of electrode array devices are connected together to form the first negative terminal of the electrode sheet, the positive terminals of the second electrode arrays of all groups of electrode array devices are connected together to form the second positive terminal of the electrode sheet, and the negative terminals of the second electrode arrays of all groups of electrode array devices are connected together to form the second negative terminal of the electrode sheet. The first positive terminal, the first negative terminal, the second positive terminal, and the second negative terminal protrude from the conductive layer to form a fixing part for connecting to the external voltage input.

[0035] Optionally, the first electrode array and the second electrode array are both centrally symmetrical in shape, or the first electrode array and the second electrode array are concentric circle structures.

[0036] Optionally, in each group of the electrode array devices, the outer edges of a plurality of first surface electrodes form an outer ring; the outer edges of a plurality of second surface electrodes form an inner ring; the outer diameter of the inner ring is 10-20 mm; and the outer diameter of the outer ring is 40-50 mm.

[0037] Optionally, the number of the first surface electrodes and the number of the second surface electrodes are both even numbers, the first electrode array includes at least two pairs of the first surface electrodes, and the second electrode array includes at least one pair of the second surface electrodes.

[0038] Optionally, the distance between adjacent first surface electrodes, the distance between adjacent second surface electrodes, and the distance between adjacent first surface electrodes and second surface electrodes are all greater than or equal to 0.5 mm and all less than 5 mm.

[0039] Optionally, both the first and second surface electrodes have rounded corners; the first surface electrode is a fan-ring structure, with a rounded top corner of the fan-ring structure having a radius not greater than 0.5 mm, and rounded side corners of the fan-ring structure having a radius not greater than 1 mm; the second surface electrode is a fan-shaped structure, with a rounded top corner of the fan-shaped structure having a radius not greater than 0.5 mm, and rounded side corners of the fan-shaped structure having a radius not greater than 1 mm; and / or, the conductivity of both the first and second surface electrodes is not less than 1 × 10⁻⁶. 6 S / m.

[0040] The beneficial effects of this invention are: The electrode array device provided by this invention, through a specially designed electrode layout and alternating positive and negative electrode array design, can effectively improve the uniformity of electric field distribution, significantly reduce the risk of electrical breakdown, improve voltage resistance, and ensure the safety and stability of treatment. The voltage resistance of this invention can reach up to 3000V, which can effectively support the high-frequency output of 3000V high voltage under the electroporation treatment system, thereby realizing cell-level penetration treatment. Attached Figure Description

[0041] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0042] Figure 1 The structure of the electrode array device in this invention is simplified. Figure 1 ; Figure 2 The structure of the electrode array device in this invention is simplified. Figure 2 ; Figure 3 The structure of the electrode array device in this invention is simplified. Figure 3 ; Figure 4 This is a schematic diagram of the electric field distribution generated by the electrode array device in this invention. Figure 1 ; Figure 5 This is a schematic diagram of the electric field distribution generated by the electrode array device in this invention. Figure 2 ; Figure 6 This is a schematic diagram of the electric field distribution generated by the electrode array device in this invention. Figure 3 ; Figure 7 A schematic diagram of the module connections for the control process of the electrode array device in this invention; Figure 8 This is an exploded view of the electrode probe in this invention; Figure 9 The structure of the electrode probe in this invention is simplified. Figure 1 ; Figure 10 The structure of the electrode probe in this invention is simplified. Figure 2 ; Figure 11 This is a simplified structural diagram of the probe housing pressure application assembly in this invention; Figure 12 yes Figure 11 Sectional view along line AA; Figure 13 This is an assembly diagram of the pressure application component and the electrode array device in this invention; Figure 14 yes Figure 13 Sectional view along the BB direction.

[0043] In the figure: 1-First electrode array; 11-First surface electrode; 2-Second electrode array; 21-Second surface electrode; 3-Probe housing; 31-Pressure application assembly; 311-First mounting slot; 312-Second mounting slot; 32-Handheld end; 4-Insulating material. Detailed Implementation

[0044] The present invention will now be described in further detail. The embodiments described below are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0045] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0046] The poor uniformity of the electric field generated by existing electrode arrays directly limits the efficacy and safety of electroporation therapy. This not only leads to incomplete ablation and increases the risk of recurrence, but also may cause electrical breakdown in the area with the highest local electric field strength due to excessively high local field strength, damaging surrounding healthy tissues or critical structures and resulting in poor pressure resistance.

[0047] To address the problem of poor electric field uniformity generated by electrode arrays in existing technologies, this invention provides an electrode array device, see [link to relevant documentation]. Figures 1-3 As shown, the electrode array device includes two electrode arrays with independently adjustable inner and outer rings, referred to as the first electrode array 1 and the second electrode array 2 for ease of understanding; specifically, the present invention preferably places the second electrode array 2 in the inner ring and the first electrode array 1 in the outer ring; wherein the first electrode array 1 includes a number of first surface electrodes 11 with alternating positive and negative electrodes; the second electrode array 2 includes a number of second surface electrodes 21 with alternating positive and negative electrodes.

[0048] During use, the first electrode array 1 located on the outer ring can be used to stimulate a larger area of ​​tissue or to form a wider electric field distribution; the second electrode array 2 located on the inner ring can provide more concentrated and precise stimulation to the core target area. Simultaneously, both the first electrode 11 and the second electrode 21 employ an alternating arrangement of positive and negative electrodes. This arrangement helps to form a more uniform and controllable electric field around the electrode array, avoiding excessively high or low local electric field strength. This improves the uniformity of the electric field, enhances the therapeutic effect, reduces damage to surrounding normal tissues, and thus improves pressure resistance.

[0049] Furthermore, the present invention preferably allows for independent control of the first electrode array 1 and the second electrode array 2. Specifically, in order to better improve the uniformity of the electric field and achieve multiple pulse drives to enhance the therapeutic effect, thereby achieving asynchronous or synchronous voltage output, in one embodiment of the present invention, the electrode array device is designed as a first electrode array 1 and a second electrode array 2 with independent control of the inner and outer rings. This allows the inner and outer electrodes to be parameter-set and discharge-controlled according to actual treatment needs, greatly improving the flexibility and precision of electrical stimulation.

[0050] like Figure 4-6 As shown, the electric field formed by the electrode array device provided by this invention is more uniform and avoids local breakdown. The electrode array device can withstand voltages up to 3000V, effectively supporting the electroporation treatment system to deliver microsecond / nanosecond-level high-frequency output of 3000V high voltage to human cell tissue, thereby achieving cell-level penetration therapy. The electrode array device of this invention is used to adhere to human cell tissue and, in conjunction with the electroporation treatment system, to achieve scar treatment or cell tissue repair.

[0051] The electrode array device provided by this invention is used for contact with human cell tissues, and in particular, the electrode structure can be used for direct contact with human cell tissues. Typically, a large number of cells with similar morphology and function within the human body aggregate together and combine with certain intercellular substances (such as matrix and fibers) to form a "cell population," which is called human cell tissue. The human cell tissues discussed in this article include human skin, epithelial tissue, muscle tissue, dermal tissue, intracavitary cell tissue, etc., and are not limited to human epidermal tissue.

[0052] The electrode array device is designed as a first electrode array 1 and a second electrode array 2 with independent control of the inner and outer rings. In one specific implementation, at least one first surface electrode 11 with a positive attribute in the first electrode array 1 serves as the positive terminal of the first electrode array 1, and at least one first surface electrode 11 with a negative attribute in the first electrode array 1 serves as the negative terminal of the first electrode array 1. At least one second surface electrode 21 with a positive attribute in the second electrode array 2 serves as the positive terminal of the second electrode array 2, and at least one second surface electrode 21 with a negative attribute in the second electrode array 2 serves as the negative terminal of the second electrode array 2.

[0053] In other words, in this invention, all the first surface electrodes 11 in the first electrode array 1 and all the second surface electrodes 21 in the second electrode array 2 can be independently controlled.

[0054] It should be noted that, to ensure the uniformity of the electric field, preferably, when a portion of the first surface electrodes 11 with positive properties in the first electrode array 1 are used as the positive terminals of the first electrode array 1, this portion of the first surface electrodes 11 used as the positive terminals is uniformly distributed; when a portion of the first surface electrodes 11 with negative properties in the first electrode array 1 are used as the negative terminals of the first electrode array 1, this portion of the first surface electrodes 11 used as the negative terminals is uniformly distributed; when a portion of the second surface electrodes 21 with positive properties in the second electrode array 2 are used as the positive terminals of the second electrode array 2, this portion of the second surface electrodes 21 used as the positive terminals is uniformly distributed; when a portion of the second surface electrodes 21 with negative properties in the second electrode array 2 are used as the negative terminals of the second electrode array 2, this portion of the second surface electrodes 21 used as the negative terminals is uniformly distributed.

[0055] The electrode array device is designed as a first electrode array 1 and a second electrode array 2 with independently adjustable inner and outer rings. Both inner and outer rings have alternating positive and negative electrodes. In the outer ring, all positive electrodes of the first surface electrodes 11 are connected in parallel to form one wire, and all negative electrodes are connected in parallel to form one wire. In the inner ring, all positive electrodes of the second surface electrodes 21 are connected in parallel to form one wire, and all negative electrodes are connected in parallel to form one wire. At least four wires are led out from the electrode array device to connect to at least a 4-pin interface of an external voltage input device. For example, all the positive first surface electrodes 11 in the first electrode array 1 are connected in parallel to form the positive terminal of the first electrode array 1, and all the negative first surface electrodes 11 are connected in parallel to form the negative terminal of the first electrode array 1. In the second electrode array 2, all the positive second surface electrodes 21 are connected in parallel to form the positive terminal of the second electrode array 2, and all the negative second surface electrodes 21 are connected in parallel to form the negative terminal of the second electrode array 2. The electrode array device has at least four electrode terminals used for external voltage input. The positive and negative terminals of the first electrode array 1 and the second electrode array 2 respectively form an electric field closed loop with human cell tissue. The first electrode array 1 and the second electrode array 2 can simultaneously input electrical pulses of the same frequency and voltage, or they can input electrical pulses of different frequencies and voltages respectively.

[0056] One specific implementation is the electrode array device provided by this invention. It should be noted that, to ensure a more uniform electric field, preferably, the first electrode array 1 and the second electrode array 2 in this invention can discharge asynchronously in two separate time periods, and the asynchronous discharge sequence is adjustable; the outer or inner rings can also discharge individually. That is, the positive and negative terminals of the first electrode array 1 and the second electrode array 2 respectively form an electric field closed loop with human cell tissue, and the first electrode array 1 and the second electrode array 2 asynchronously control input the same or different voltages, or asynchronously control input the same or different electrical pulses. Asynchronous control here means that the first electrode array 1 and the second electrode array 2 are not simultaneously input with voltage. For example, the first electrode array 1 may receive voltage first, followed by the second electrode array 2, or the second electrode array 2 may receive voltage first, followed by the first electrode array 1. The asynchronous control time difference, i.e., the time difference between the first electrode array 1 and the second electrode array 2 receiving the input voltage, is on the order of nanoseconds or milliseconds. The aforementioned "same input" can be the same voltage input and / or the same frequency input.

[0057] The electrode array device provided by this invention, through the independently adjustable electrode layout of the inner and outer rings and the alternating discharge design, can effectively improve the uniformity of the electric field distribution, significantly reduce the risk of electrical breakdown, improve the withstand voltage, and ensure the safety and stability of treatment.

[0058] When the electrode array in this invention is used for electroporation treatment, the first electrode array 1 and the second electrode array 2 do not distinguish between reversible and irreversible arrays. The reversible or irreversible treatment is controlled by the amount of energy input. Specifically, an array with high energy input can perform irreversible treatment, while an array with low energy input can perform reversible treatment.

[0059] Due to poor electric field uniformity and low voltage resistance, existing electroporation devices for skin management are based on reversible electroporation, with low output pulse energy. They are only used to promote skin penetration and absorption, and cannot treat scars. Their single function limits the application of electroporation technology in the field of skin management. In this invention, the first electrode array 1 and the second electrode array 2 can be independently controlled, so that independent irreversible electroporation treatment or reversible electroporation treatment can be selected according to the needs.

[0060] To improve the uniformity of the electric field distribution, the present invention preferably uses the first electrode array 1 and the second electrode array 2 as centrally symmetrical shapes. The centrally symmetrical design enables the electrode array to generate a symmetrical electric field distribution during operation, ensuring the uniformity of the electric field distribution.

[0061] Existing electroporation devices for skin treatment mostly employ microneedle array electrodes, allowing the microneedles to penetrate the skin surface and directly contact the underlying tissues during treatment. However, microneedle puncture of the skin surface causes minor damage and inevitably leads to stinging. This invention innovatively uses surface electrodes as the electrodes, combining an independently adjustable first electrode array 1 and a second electrode array 2, achieving synergistic "ablation-repair" treatment without the need for punctures. The first surface electrode 11 and the second surface electrode 21 mentioned in this paper are conductive bodies with a predetermined area, rather than microneedle structures.

[0062] Furthermore, the present invention preferably uses a concentric circle structure for the first electrode array 1 and the second electrode array 2. The concentric circle structure is a simple and efficient centrally symmetrical layout, which can ensure that the inner circle second electrode array 2 and the outer circle first electrode array 1 have good spatial symmetry and concentricity, making the electric field gradient change from the center to the periphery more regular and uniform, and also facilitating the processing, manufacturing and assembly of the electrode probe.

[0063] Specifically, the present invention preferably has an outer ring formed by the outer edges of a plurality of first surface electrodes 11 and an inner ring formed by the outer edges of a plurality of second surface electrodes 21; and further preferably, the outer diameter of the inner ring is 10-20 mm to avoid the electrode array size being too small, which would cause the current density to be excessively concentrated and easily lead to electrical breakdown; the outer diameter of the outer ring is 40-50 mm to avoid the electrode array size being too large, which would lead to a decrease in the current density per unit area, an accelerated decay of the electric field strength, and an inability to form an effective perforation area.

[0064] Preferably, the number of first surface electrodes 11 and the number of second surface electrodes 21 are both even numbers. More preferably, the first electrode array 1 includes at least two pairs of first surface electrodes 11 and the second electrode array 2 includes at least one pair of second surface electrodes 21. An even number of surface electrodes facilitates the complete alternation of positive and negative electrodes, ensuring that adjacent electrodes of each surface electrode are of opposite polarity, thereby forming a stable electric dipole structure, which is beneficial for generating a uniform and directionally controllable electric field.

[0065] Since the electrode plates in this invention are arranged in a completely alternating pattern of positive and negative electrodes, the final current in the electrode array provided by this invention does not converge to the same positive electrode or the same negative electrode, but is dispersed among multiple positive electrodes and multiple negative electrodes, which helps to improve the uniformity of the electric field distribution.

[0066] Furthermore, in this invention, a plurality of first surface electrodes 11 located on the outer ring and a plurality of second surface electrodes 21 located on the inner ring are double-ring separated electrodes. These double-ring separated electrodes constitute a combined electrode array. The positive and negative electrodes in the combined electrode array have the same area, which makes the current density distribution uniform, thereby ensuring the uniformity of the electric field distribution.

[0067] The specific number of the first electrode 11 and the second electrode 21 can be set according to the requirements. In this invention, the number of the first electrode 11 is eight or ten, and the number of the second electrode 21 is two or four, so as to avoid the risk of electrical breakdown caused by excessive electrode density and the uneven electric field caused by excessive density.

[0068] Specifically, see the schematic diagram of the electric field generated by the electrode array in this invention. Figure 4-6 As shown, where, Figure 4 The first surface electrode 11 has eight electrodes, and the second surface electrode 21 has two electrodes. Figure 5 The first surface electrode 11 has eight electrodes, and the second surface electrode 21 has four electrodes. Figure 6 The number of first-side electrodes 11 is ten, and the number of second-side electrodes 21 is four. The green part in the figure is the boundary of the 200V / cm electric field.

[0069] The present invention preferably specifies that the distance between adjacent first electrode 11, the distance between adjacent second electrode 21, and the distance between adjacent first electrode 11 and second electrode 21 are all greater than or equal to 1 mm, but less than 5 mm, and further preferably 1-3 mm, so as to avoid strong edge field effect caused by too close spacing, which would lead to a sudden increase in current density in the electric field superposition area and significantly increase the risk of electrical breakdown; if the spacing is too far, the electric field coverage will be discontinuous, forming a treatment blind zone, which directly reduces the ablation efficiency of abnormal tissue and the uniformity of repair drug penetration.

[0070] Preferably, the edges and corners of both the first electrode 11 and the second electrode 21 are rounded to effectively reduce the edge electric field intensity, avoid electric field concentration at the corners of the electrodes, thereby reducing the generation of electric sparks and unnecessary damage to tissues, and improving safety. Specifically, the first electrode 11 is preferably a fan-ring structure, with a rounded top corner and a radius of no more than 0.5 mm. The side corners of the fan-ring structure are also rounded. The first electrode 21 has a fan-shaped structure with rounded corners on the top surface of the fan-shaped structure, the radius of which is no greater than 0.5 mm. The second electrode 21 has rounded corners on the side surface of the fan-shaped structure, the radius of which is no greater than 1 mm. This design prevents a sudden increase in local charge density (edge ​​field effect) caused by sharp edges, which could lead to electrical breakdown. It also avoids discontinuities in the electric field caused by excessively large rounded corner radii.

[0071] Preferably, the conductivity (20℃, S / m) of both the first electrode 11 and the second electrode 21 in this invention is not less than 1×10⁻⁶. 6 S / m; Specifically, the first electrode 11 and the second electrode 21 are preferably made of at least one material selected from silver and brass. High-conductivity electrode materials ensure efficient transmission of electrical pulse energy, reduce energy loss within the electrode itself, and guarantee that more energy reaches the target tissue. The conductivity is not less than 1×10⁻⁶. 6 The S / m requirement ensures that the surface electrode has good conductivity, meeting the current intensity and energy transmission efficiency required for clinical electrical stimulation or ablation.

[0072] A preferred control method for the electrode array device of the present invention as described above includes: setting the pulse parameters and discharge sequence of the first electrode array 1 and the second electrode array 2 according to the treatment plan; and releasing pulse voltages of the first electrode array 1 and the second electrode array 2 according to the pulse parameters and discharge sequence.

[0073] The specific treatment plan includes: determining the pulse input parameters; determining which electrodes to discharge and the discharge sequence; the setting of these pulse parameters mainly depends on the selected treatment method. It is important to emphasize that in reversible and irreversible treatments, irreversible electroporation only results in an irreversible electric field region near the electrodes; the distal region, due to its distance from the electrodes and lower energy, remains reversible. Therefore, irreversible treatment can still promote penetration and absorption. On the other hand, the treatment also depends on the skin condition at the target location, such as the size of the scar and the electrical characteristics of the scar. Specifically, setting pulse parameters can include pulse-related parameters such as temperature (T), impedance (R), number of pulse trains (N), pulse width (W), and voltage (U), as well as setting an upper temperature limit to ensure operational safety.

[0074] The control method for the electrode array device provided by this invention, through the independent adjustment of the electrode layout of the inner and outer rings and the alternating discharge design, can effectively improve the uniformity of the electric field distribution, significantly reduce the risk of electrical breakdown, improve the withstand voltage, and ensure the safety and stability of treatment.

[0075] Another object of the present invention is to provide a control method for the electrode array device as described above, see [link to previous document]. Figure 7 As shown, this includes: independently setting parameters and controlling discharge for the first electrode array 1 and the second electrode array (2) respectively.

[0076] Specifically, this control method controls the switching and pulse output control of the inner and outer rings through the control module and storage module of the host computer system; wherein, the parameter settings of the first electrode array 1 and the second electrode array 2 can be the same or different, and can be set according to actual needs.

[0077] By independently setting parameters and controlling the discharge of the first electrode array 1 and the second electrode array 2, the first electrode array 1 and the second electrode array 2 can be independently adjusted respectively. This allows the first electrode array 1 and the second electrode array 2 to be set and controlled according to actual treatment needs, which greatly improves the flexibility and precision of electrical stimulation while ensuring the uniformity of the electric field.

[0078] Specifically, discharging control of the first electrode array 1 and the second electrode array 2 includes applying electrical pulses to the first electrode array 1 and the second electrode array 2 in a synchronous or asynchronous manner.

[0079] To ensure a more uniform electric field, the present invention preferably performs discharge control on the first electrode array 1 and the second electrode array 2 separately, including applying electrical pulses to the first electrode array 1 and the second electrode array 2 asynchronously.

[0080] In other words, the first electrode array 1 and the second electrode array 2 in this invention can discharge asynchronously in two separate time periods, and the asynchronous discharge sequence is adjustable; the outer or inner rings can also discharge individually. Specifically, the positive and negative terminals of the first electrode array 1 and the second electrode array 2 respectively form an electric field closed loop with human cell tissue, and the first electrode array 1 and the second electrode array 2 asynchronously control input the same or different voltages, or asynchronously control input the same or different electrical pulses. Asynchronous control here means that the first electrode array 1 and the second electrode array 2 are not simultaneously input with voltage. For example, the first electrode array 1 may receive voltage first, followed by the second electrode array 2, or the second electrode array 2 may receive voltage first, followed by the first electrode array 1. The asynchronous control time difference, i.e., the time difference between the first electrode array 1 and the second electrode array 2 receiving the input voltage, is on the order of nanoseconds or milliseconds. The aforementioned "same input" can be the same voltage input and / or the same frequency input.

[0081] In one embodiment of the present invention, a first electrode array 1 includes a plurality of first surface electrodes 11 with alternating positive and negative electrodes; a second electrode array 2 includes a plurality of second surface electrodes 21 with alternating positive and negative electrodes; at least one first surface electrode 11 with a positive attribute is connected as the positive terminal of the first electrode array 1, and at least one first surface electrode 11 with a negative attribute is connected as the negative terminal of the first electrode array 1; a first electric field closed loop is formed with human cell tissue through the positive and negative terminals of the first electrode array 1; at least one second surface electrode 21 with a positive attribute is connected as the positive terminal of the second electrode array 2, and at least one second surface electrode 21 with a negative attribute is connected as the negative terminal of the second electrode array 2; a second electric field closed loop is formed with human cell tissue through the positive and negative terminals of the second electrode array 2; discharge control of the first electrode array 1 and the second electrode array 2 includes: independently regulating the electrical pulse signals in the first electric field closed loop and the second electric field closed loop respectively.

[0082] In other words, in this invention, all the first surface electrodes 11 in the first electrode array 1 and all the second surface electrodes 21 in the second electrode array 2 can be independently controlled.

[0083] Furthermore, to ensure the uniformity of the electric field, it is preferable that at least one first surface electrode 11 connected as a positive terminal is uniformly distributed in the first electrode array 1, and at least one first surface electrode 11 connected as a negative terminal is uniformly distributed in the first electrode array 1. And / or, at least one second-side electrode 21 connected as a positive terminal is uniformly distributed in the second electrode array 2, and at least one second-side electrode 21 connected as a negative terminal is uniformly distributed in the second electrode array 2.

[0084] That is, when a portion of the first surface electrodes 11 with positive properties in the first electrode array 1 serve as the positive terminal of the first electrode array 1, the portion of the first surface electrodes 11 serving as the positive terminal is a uniformly distributed surface electrode; when a portion of the first surface electrodes 11 with negative properties in the first electrode array 1 serve as the negative terminal of the first electrode array 1, the portion of the first surface electrodes 11 serving as the negative terminal is a uniformly distributed surface electrode; when a portion of the second surface electrodes 21 with positive properties in the second electrode array 2 serve as the positive terminal of the second electrode array 2, the portion of the second surface electrodes 21 serving as the positive terminal is a uniformly distributed surface electrode; when a portion of the second surface electrodes 21 with negative properties in the second electrode array 2 serve as the negative terminal of the second electrode array 2, the portion of the second surface electrodes 21 serving as the negative terminal is a uniformly distributed surface electrode.

[0085] Another embodiment of the present invention is as follows: the first electrode array 1 includes a plurality of first surface electrodes 11 with alternating positive and negative electrodes; the second electrode array 2 includes a plurality of second surface electrodes 21 with alternating positive and negative electrodes; all the first surface electrodes 11 with positive polarity are connected in parallel to form the positive terminal of the first electrode array 1, and all the first surface electrodes 11 with negative polarity are connected in parallel to form the negative terminal of the first electrode array 1; the positive and negative terminals of the first electrode array 1 are used to form a connection with human cell tissue. The first electric field closed loop; all the second surface electrodes 21 with positive polarity are connected in parallel to form the positive terminal of the second electrode array 2, and all the second surface electrodes 21 with negative polarity are connected in parallel to form the negative terminal of the second electrode array 2; the positive and negative terminals of the second electrode array 2 form a second electric field closed loop with human cell tissue; the discharge control of the first electrode array 1 and the second electrode array 2 includes: independently regulating the electrical pulse signals in the first electric field closed loop and the second electric field closed loop respectively.

[0086] In other words, both the first electrode array 1 and the second electrode array 2 have alternating positive and negative electrodes. Among the plurality of first surface electrodes 11, all positive electrodes are connected in parallel to form one wire, and all negative electrodes are connected in parallel to form one wire. Among the plurality of second surface electrodes 21, all positive electrodes are connected in parallel to form one wire, and all negative electrodes are connected in parallel to form one wire. A total of at least four wires are led out from the electrode array device to connect to at least a 4-pin interface of an external voltage input device. For example, all the first surface electrodes 11 with positive properties in the first electrode array 1 are connected in parallel to form the positive terminal of the first electrode array 1, and all the first surface electrodes 11 with negative properties in the first electrode array 1 are connected in parallel to form the negative terminal of the first electrode array 1. In the second electrode array 2, all the second surface electrodes 21 with positive properties are connected in parallel to form the positive terminal of the second electrode array 2, and all the second surface electrodes 21 with negative properties in the second electrode array 2 are connected in parallel to form the negative terminal of the second electrode array 2. The electrode array device has at least 4 electrode terminals used for external voltage input. The positive and negative terminals of the first electrode array 1 and the second electrode array 2 respectively form an electric field closed loop with human cell tissue. The first electrode array 1 and the second electrode array 2 can simultaneously input electrical pulses of the same frequency and voltage, or they can input electrical pulses of different frequencies and voltages respectively.

[0087] The control method of the electrode array device provided by this invention makes the electric field formed by the electrode array device more uniform and avoids local breakdown. The electrode array device can withstand voltages up to 3000V, which can effectively support the electroporation treatment system to achieve high-frequency output of 3000V high voltage to human cells and tissues at the microsecond / nanosecond level, thereby realizing cell-level penetration therapy.

[0088] Another object of the present invention is to provide an electrode probe, see [link to previous document]. Figure 8 , Figure 9 As shown, the electrode probe includes a probe housing 3 and an electrode array device as described above. The electrode array device is disposed on the top surface of the probe housing 3 and is used to contact human cells and tissues. The electrode array device is the structure mentioned in the previous embodiment, specifically: the electrode array device includes a first electrode array 1 and a second electrode array 2; the second electrode array 2 is located in the inner circle, and the first electrode array 1 is located in the outer circle; the first electrode array 1 includes a plurality of first surface electrodes 11 with alternating positive and negative electrodes; the second electrode array 2 includes a plurality of second surface electrodes 21 with alternating positive and negative electrodes.

[0089] The probe housing 3 provides stable support and good insulation protection for the electrode array device, preventing current leakage and the risk of electric shock to operators.

[0090] The electrode probe also includes a voltage control board; wherein the probe housing 3 includes a pressure application component 31 and a handheld end 32, the handheld end 32 and the pressure application component 31 forming an internal cavity for accommodating the voltage control board; the pressure application component 31 has a top surface for fixing the electrode array device; all the first surface electrodes 11 of the positive polarity in the first electrode array 1 are connected in parallel to form the positive terminal of the first electrode array 1, all the first surface electrodes 11 of the negative polarity in the first electrode array 1 are connected in parallel to form the negative terminal of the first electrode array 1, all the second surface electrodes 21 of the positive polarity in the second electrode array 2 are connected in parallel to form the positive terminal of the second electrode array 2, all the second surface electrodes 21 of the negative polarity in the second electrode array 2 are connected in parallel to form the negative terminal of the second electrode array 2, the electrode array device has at least two pairs of positive and negative terminals, and at least two pairs of positive and negative terminals are electrically connected to the voltage control board.

[0091] The pressure application component 31 is specifically used to fix the electrode array, ensuring the positional stability and reliability of the electrode array during use. For ease of operation, the present invention preferably uses a handheld electrode probe, and the handheld end 32 is convenient for the operator to hold and operate the probe, improving the convenience and accuracy of use. The present invention preferably uses the pressure application component 31 and the handheld end 32 to be fixedly connected by threads, ultrasonic welding, or adhesive.

[0092] Specifically, the two electrode arrays, the first electrode array 1 and the second electrode array 2, which are independently adjustable between the inner and outer rings in this invention, are both disposed on the pressure application component 31.

[0093] Since the electrode probe provided by the present invention includes both a first electrode array 1 and a second electrode array 2, and the first electrode array 1 and the second electrode array 2 can be independently controlled, the electrode probe provided by the present invention can achieve synergistic treatment of "ablation of abnormal tissue + promotion of repair", thus breaking through the core pain point of "high recurrence" in scar treatment.

[0094] The electrode probe provided by this invention, through the independently adjustable electrode layout of the inner and outer rings and the alternating discharge design, can effectively improve the uniformity of the electric field distribution, significantly reduce the risk of electrical breakdown, improve the voltage resistance, and ensure the safety and stability of treatment.

[0095] To facilitate the installation of the electrode sheet, the present invention preferably provides a groove for installing the electrode sheet on the pressure application component 31, the number, position and shape of which are determined according to the electrode sheet.

[0096] The groove design provides precise positioning and fixing space for the surface electrode installation, ensuring that the surface electrode can be firmly installed in the preset position and preventing displacement or detachment during use. At the same time, the groove also helps protect the surface electrode, reducing direct collisions and wear with external objects.

[0097] For details, see Figure 11 As shown, the present invention preferably provides a second mounting groove 312 for mounting the second surface electrode 21 and a first mounting groove 311 for mounting the first surface electrode 11 on the pressure application component 31; the second surface electrode 21 is fixed in the second mounting groove 312, and the first surface electrode 11 is fixed in the first mounting groove 311. See also... Figure 12 As shown, the second mounting groove 312 and the first mounting groove 311 have through holes to provide channels for the soldering connection between the wires and the surface electrode. Specifically, the wires pass through the round holes in the electrode groove of the electrode probe and are directly soldered to the bottom surface of the electrode. All the wires are bundled together as a wire harness and led out from the central channel of the electrode probe to the device interface.

[0098] To facilitate closer contact with human cells and tissues, in one embodiment, see [link to embodiment]. Figure 13 , Figure 14 As shown, both the first electrode 11 and the second electrode 21 on the electrode array device have a convex surface for contacting human cells and tissues. This convex surface has a smooth outer edge and protrudes beyond the top surface of the pressure-applying component 31. For example, preferably, after the electrode is fixed in a corresponding groove on the probe housing 3, the height difference between the electrode and the external contact surface and the top surface of the probe housing 3 is no greater than 0.5 mm. That is, preferably, the height difference between the outer end of the electrode array device (the end that contacts the skin during operation) and the top surface of the probe housing 3 (the end closest to the skin during operation) is less than 0.5 mm, to reduce the air volume between the electrode pieces and lower the risk of electrical breakdown under extremely small electrode spacing. Preferably, when the electrode array device contacts human cells and tissues, the height difference between the convex surface of the electrode and the top surface of the probe housing 3 is no greater than 0.5 mm.

[0099] In the preferred embodiment of the present invention, the outer edges of a plurality of first-side electrodes 11 form an outer ring; the outer edges of a plurality of second-side electrodes 21 form an inner ring; the outer diameter of the inner ring is 10-20 mm; and the outer diameter of the outer ring is 40-50 mm.

[0100] Preferably, the number of first surface electrodes 11 and the number of second surface electrodes 21 are both even numbers. The first electrode array 1 includes at least two pairs of first surface electrodes 11, and the second electrode array 2 includes at least one pair of second surface electrodes 21.

[0101] Preferably, the distance between adjacent first surface electrodes 11, the distance between adjacent second surface electrodes 21, and the distance between adjacent first surface electrodes 11 and second surface electrodes 21 are all greater than or equal to 1 mm and less than 5 mm.

[0102] Preferably, the edges and corners of both the first electrode 11 and the second electrode 21 are provided with rounded corner structures; the first electrode 11 is a fan-ring structure, the top edge of the fan-ring structure is a rounded corner structure with a radius not greater than 0.5 mm, and the side edge of the fan-ring structure is a rounded corner structure with a radius not greater than 1 mm; the second electrode 21 is a fan-shaped structure, the top edge of the fan-shaped structure is a rounded corner structure with a radius not greater than 0.5 mm, and the side edge of the fan-shaped structure is a rounded corner structure with a radius not greater than 1 mm.

[0103] To further enhance security, see Figure 10 As shown, the present invention preferably fills the space between adjacent surface electrodes with insulating material 4 to effectively reduce the risk of electrical breakdown. At the same time, the insulating material 4 can also fix the electrode sheet and fill the gap.

[0104] Furthermore, the present invention preferably has an insulating material 4 with a Shore hardness of no more than 80, so that the insulating material 4 has a certain degree of flexibility and elasticity. When the electrode array comes into contact with human tissue, it can better adapt to the contour of the tissue surface, reduce contact pressure, improve patient comfort, and at the same time reduce mechanical stimulation and damage to the tissue.

[0105] The dielectric strength of the insulating material 4 is preferably not less than 3kV / mm. The high dielectric strength ensures that the insulating material 4 will not be broken down under the action of high voltage pulse, and can effectively block the current path between adjacent surface electrodes, ensuring the normal operation and safe use of the electrode array device.

[0106] Specifically, the present invention preferably uses silicone rubber as the insulating material 4, and more specifically, the type of insulating material 4 is DC184 polydimethylsiloxane elastomer potting compound.

[0107] Furthermore, the dielectric constant of the probe housing 3 is preferably not less than 3.5, so that the probe housing 3 has good electrical insulation properties, which can effectively isolate the electrode array device from the external environment, prevent charge accumulation and electrostatic interference, and at the same time help maintain the stability of the electric field around the electrode array device, and reduce the adverse effects of poor insulation material performance on the electric field distribution.

[0108] Meanwhile, the present invention preferably has all thin-wall thicknesses of the probe housing 3 >0.2mm, thereby avoiding leakage or cross-interference under high voltage pulses (1-3kV).

[0109] Preferably, the conductivity (20℃, S / m) of both the first electrode 11 and the second electrode 21 in this invention is not less than 1×10⁻⁶. 6 S / m.

[0110] The voltage control board mentioned in the above embodiments can be a conversion circuit that serves as the voltage input for the first electrode 11 or the second electrode 21. The provided electrode probe is an independent accessory structure that needs to be connected to an external power supply and control device to realize the above-mentioned method of controlling the voltage output of the first electrode 11 and the second electrode 21. Of course, the voltage control board mentioned in the above embodiments can also include control circuits such as a power supply circuit and a voltage conversion circuit (e.g., a high-voltage conversion circuit for outputting high-voltage high-frequency electrical pulses), so that the provided electrode probe can be a device that can independently realize the voltage output control method for the first electrode 11 and the second electrode 21, so as to realize power supply and voltage (electrical pulse) output without the need for an external power supply and control device. Therefore, the electrode probe provided by the present invention, as an accessory, can be mainly composed of an electrode array device composed of surface electrodes and a probe housing 3. The electrode probe has a lead wire at the end connected to the power supply host, and the power supply host controls the discharge of the electrode probe.

[0111] Furthermore, the present invention also provides an electrode sheet structure, which includes a stacked substrate layer, an adhesive layer, and a conductive layer, wherein the conductive layer includes at least one set of the aforementioned electrode array devices; each set of electrode array devices includes a first electrode array 1 and a second electrode array 2; the second electrode array 2 is located in the inner circle, and the first electrode array 1 is located in the outer circle; the first electrode array 1 includes a plurality of first surface electrodes 11 with alternating positive and negative electrodes; the second electrode array 2 includes a plurality of second surface electrodes 21 with alternating positive and negative electrodes. The electrode sheet provided in this embodiment is an accessory that needs to be used in conjunction with an external power supply and control equipment to control the voltage output of the first surface electrodes 11 and the second surface electrodes 21.

[0112] The base layer mentioned in this embodiment can be a soft and breathable non-woven fabric, silicone, or polyester film, used to provide mechanical support, allowing the electrode pads to conform to the curves of the human body and enhancing wearing comfort. The adhesive layer mentioned in this embodiment, made of medical-grade acrylic or rubber-based adhesive, must be hypoallergenic to ensure long-term adhesion without detachment or skin damage. The conductive layer mentioned in this embodiment can be composed of hydrogel or carbon fiber / silver fiber fabric, with at least one set of electrode array devices embedded in the middle. This is the key channel for charge transfer, responsible for transmitting the input voltage to human cells and tissues.

[0113] In one example of the present invention, in each group of electrode array devices, all the first surface electrodes 11 of the first electrode array 1 that are positive are connected in parallel to form the positive terminal of the first electrode array 1, and all the first surface electrodes 11 of the first electrode array 1 that are negative are connected in parallel to form the negative terminal of the first electrode array 1. In the second electrode array 2, all the second surface electrodes 21 of the second electrode array 2 that are positive are connected in parallel to form the positive terminal of the second electrode array 2, and all the second surface electrodes 21 of the second electrode array 2 that are negative are connected in parallel to form the negative terminal of the second electrode array 2. Each group of electrode array devices has at least 4 electrodes. The terminals are used as external voltage inputs; the positive terminals of the first electrode array 1 of all the electrode array devices are connected together to form the first positive electrode of the electrode sheet, the negative terminals of the first electrode array 1 of all the electrode array devices are connected together to form the first negative electrode of the electrode sheet, the positive terminals of the second electrode array 2 of all the electrode array devices are connected together to form the second positive electrode of the electrode sheet, and the negative terminals of the second electrode array 2 of all the electrode array devices are connected together to form the second negative electrode of the electrode sheet; the first positive electrode, the first negative electrode, the second positive electrode, and the second negative electrode protrude from the conductive layer to form a fixing part for connecting the external voltage input.

[0114] To improve the uniformity of the electric field distribution, the present invention preferably has the first electrode array 1 and the second electrode array 2 as centrally symmetrical shapes, and / or the first electrode array 1 and the second electrode array 2 as concentric circle structures.

[0115] Specifically, in each electrode array device, the outer edges of a plurality of first-side electrodes 11 form an outer ring; the outer edges of a plurality of second-side electrodes 21 form an inner ring; preferably, the outer diameter of the inner ring is 10-20 mm to avoid the electrode array size being too small, causing excessive current density concentration and easily leading to electrical breakdown; the outer diameter of the outer ring is 40-50 mm to avoid the electrode array size being too large, which would lead to a decrease in current density per unit area, faster attenuation of electric field strength, and inability to form an effective perforation area.

[0116] Preferably, the number of first surface electrodes 11 and the number of second surface electrodes 21 are both even. The first electrode array 1 includes at least two pairs of first surface electrodes 11, and the second electrode array 2 includes at least one pair of second surface electrodes 21. An even number of surface electrodes facilitates the complete alternation of positive and negative electrodes, ensuring that the adjacent electrodes of each surface electrode are of opposite polarity, thereby forming a stable electric dipole structure, which is beneficial for generating a uniform and directionally controllable electric field.

[0117] The present invention preferably specifies that the distance between adjacent first electrode 11, the distance between adjacent second electrode 21, and the distance between adjacent first electrode 11 and second electrode 21 are all greater than or equal to 0.5 mm and less than 5 mm, and further preferably 1-3 mm, so as to avoid strong edge field effect caused by too close spacing, which would lead to a sudden increase in current density in the electric field superposition area and significantly increase the risk of electrical breakdown; if the spacing is too far, the electric field coverage will be discontinuous, forming a treatment blind zone, which directly reduces the ablation efficiency of abnormal tissue and the uniformity of repair drug penetration.

[0118] Furthermore, the present invention preferably provides rounded corner structures on the edges of both the first electrode 11 and the second electrode 21; the radius of the rounded corner structure is not greater than 2 mm; and / or, the conductivity of both the first electrode 11 and the second electrode 21 is not less than 1 × 10⁻⁶. 6 S / m.

[0119] Specifically, the first electrode 11 of the present invention preferably has a fan-ring structure, with rounded corners on the top surface of the fan-ring structure and a radius of no more than 0.5 mm, and rounded corners on the side surface of the fan-ring structure and a radius of no more than 1 mm; the second electrode 21 has a fan-shaped structure, with rounded corners on the top surface of the fan-shaped structure and a radius of no more than 0.5 mm, and rounded corners on the side surface of the fan-shaped structure and a radius of no more than 1 mm. This design prevents a sudden increase in local charge density (edge ​​field effect) caused by sharp edges, which could lead to electrical breakdown; and also avoids discontinuities in the electric field caused by excessively large rounded corner radii.

[0120] Preferably, the conductivity (20℃, S / m) of both the first electrode 11 and the second electrode 21 in this invention is not less than 1×10⁻⁶. 6 S / m; Specifically, the first electrode 11 and the second electrode 21 are preferably made of at least one material selected from silver and brass. High-conductivity electrode materials ensure efficient transmission of electrical pulse energy, reduce energy loss within the electrode itself, and guarantee that more energy reaches the target tissue. The conductivity is not less than 1×10⁻⁶. 6 The S / m requirement ensures that the surface electrode has good conductivity, meeting the current intensity and energy transmission efficiency required for clinical electrical stimulation or ablation.

[0121] Furthermore, this invention, through an independently adjustable electrode layout and alternating discharge design of inner and outer rings, enables synergistic treatment of irreversible electroporation ablation of abnormal tissue and reversible electroporation promoting the penetration of repair drugs, overcoming the limitations of a single electroporation mode. Employing a contact-type rather than a puncture-type electrode, combined with an alternating inner and outer ring discharge method, it reduces neuromuscular stimulation intensity while providing a uniform electric field, significantly reducing pain and muscle spasms, and improving treatment comfort. Through a dynamic pulse parameter control system and optimized electrode size, spacing, number, and shape, it ensures a uniform electric field distribution. Simultaneously, the rounded corner transitions at the electrode contact ends and the insulating dielectric filling structure effectively suppress edge field effects, significantly reducing the risk of electrical breakdown and improving treatment safety and stability.

[0122] Existing electroporation devices for skin management are based on reversible electroporation, with low output pulse energy, used to promote skin penetration and absorption. The electrode probe provided by this invention can be used in electrode systems with high pulse energy output. Specifically, this invention innovatively designs the electrode structure and array, and employs an independent control method for the inner and outer electrode rings, constructing an integrated "structure-control-efficiency" technical solution. Its core mechanism is reflected in achieving precise and uniform electric field distribution and reducing the risk of electrical breakdown through "structure and array design + discharge timing coordination." The innovative array electrode layout, combined with an alternating discharge method that independently drives the inner and outer ring electrodes, along with optimized electrode size and array spacing, improves electroporation efficiency and the uniformity of the pulsed electric field, while also enhancing the ability to avoid electrical breakdown. At the electrode structure level, the shape and number of electrodes are comprehensively considered. Edge and tip effects caused by excessively small radii of curvature are avoided at the edges or tips of the electrodes. A close-fitting electrode probe structure is designed to reduce the electrode protrusion height, or high-dielectric-constant insulating glue is used to fill the electrode gaps to reduce field strength distortion caused by residual air. At the control level, a real-time impedance measurement and temperature monitoring module is integrated, combined with a dynamic pulse parameter adjustment system, which greatly reduces the risk of electrical breakdown during discharge.

[0123] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. An electrode array device, characterized by, The electrode array device comprises a first electrode array (1) and a second electrode array (2) independently regulated by inner and outer rings; the second electrode array (2) is located in the inner ring, and the first electrode array (1) is located in the outer ring; the first electrode array (1) comprises a plurality of first surface electrodes (11) with positive and negative electrodes arranged alternately; and the second electrode array (2) comprises a plurality of second surface electrodes (21) with positive and negative electrodes arranged alternately.

2. The electrode array device of claim 1, wherein, At least one of the first surface electrodes (11) with positive electrodes in the first electrode array (1) serves as the positive terminal of the first electrode array (1), at least one of the first surface electrodes (11) with negative electrodes in the first electrode array (1) serves as the negative terminal of the first electrode array (1), at least one of the second surface electrodes (21) with positive electrodes in the second electrode array (2) serves as the positive terminal of the second electrode array (2), and at least one of the second surface electrodes (21) with negative electrodes in the second electrode array (2) serves as the negative terminal of the second electrode array (2).

3. The electrode array device of claim 1, wherein, All the first surface electrodes (11) with positive electrodes in the first electrode array (1) are connected in parallel to form the positive terminal of the first electrode array (1), all the first surface electrodes (11) with negative electrodes in the first electrode array (1) are connected in parallel to form the negative terminal of the first electrode array (1), all the second surface electrodes (21) with positive electrodes in the second electrode array (2) are connected in parallel to form the positive terminal of the second electrode array (2), and all the second surface electrodes (21) with negative electrodes in the second electrode array (2) are connected in parallel to form the negative terminal of the second electrode array (2), and the electrode array device has at least four electrode terminals for external voltage input.

4. The electrode array device of claim 1, wherein, The shapes of the first electrode array (1) and the second electrode array (2) are both center-symmetric figures.

5. The electrode array device of claim 1, wherein, The first electrode array (1) and the second electrode array (2) are concentric circular structures.

6. The electrode array device of claim 5, wherein, The outer edges of a plurality of the first surface electrodes (11) form an outer ring, and the outer edges of a plurality of the second surface electrodes (21) form an inner ring; the outer diameter of the inner ring is 10-20 mm, and the outer diameter of the outer ring is 40-50 mm.

7. The electrode array device of claim 1, wherein, The number of the first surface electrodes (11) and the number of the second surface electrodes (21) are both even numbers, the first electrode array (1) comprises at least two pairs of the first surface electrodes (11), and the second electrode array (2) comprises at least one pair of the second surface electrodes (21).

8. The electrode array device of claim 1, wherein, The distance between adjacent first surface electrodes (11), the distance between adjacent second surface electrodes (21), and the distance between adjacent first surface electrodes (11) and second surface electrodes (21) are all greater than or equal to 1 mm and less than 5 mm.

9. The electrode array device of claim 1, wherein, The edge corners of the first surface electrode (11) and the second surface electrode (21) are provided with a rounded structure; the first surface electrode (11) is a fan ring structure, the top corner of the fan ring structure is a rounded structure, the radius of the rounded structure is not greater than 0.5mm, the side corner of the fan ring structure is a rounded structure, and the radius of the rounded structure is not greater than 1mm; the second surface electrode (21) is a fan structure, the top corner of the fan structure is a rounded structure, the radius of the rounded structure is not greater than 0.5mm, the side corner of the fan structure is a rounded structure, and the radius of the rounded structure is not greater than 1mm.

10. The electrode array device of any one of claims 1 to 9, wherein, The electrical conductivity of the first surface electrode (11) and the second surface electrode (21) is not less than 1 x 10 6 S / m.

11. A method of controlling an electrode array device as claimed in any one of claims 1 to 10, characterized in that, Comprise: The first electrode array (1) and the second electrode array (2) are independently parameterized and discharge controlled.

12. The method of controlling an electrode array device according to claim 11, wherein, The discharge control of the first electrode array (1) and the second electrode array (2) includes applying electric pulses to the first electrode array (1) and the second electrode array (2) in a synchronous or asynchronous manner.

13. The method of controlling an electrode array device according to claim 11, wherein The discharge control of the first electrode array (1) and the second electrode array (2) includes applying electric pulses to the first electrode array (1) and the second electrode array (2) in an asynchronous manner.

14. The method of controlling an electrode array device according to claim 11, wherein The first electrode array (1) comprises a plurality of first surface electrodes (11) arranged alternately with positive and negative electrodes; the second electrode array (2) comprises a plurality of second surface electrodes (21) arranged alternately with positive and negative electrodes; at least one first surface electrode (11) with a positive attribute in the first surface electrode (11) is connected as a positive terminal of the first electrode array (1), and at least one first surface electrode (11) with a negative attribute in the first surface electrode (11) is connected as a negative terminal of the first electrode array (1); a first electric field closed loop is formed through the positive terminal and the negative terminal of the first electrode array (1); at least one second surface electrode (21) with a positive attribute in the second surface electrode (21) is connected as a positive terminal of the second electrode array (2), and at least one second surface electrode (21) with a negative attribute in the second surface electrode (21) is connected as a negative terminal of the second electrode array (2); a second electric field closed loop is formed through the positive terminal and the negative terminal of the second electrode array (2); The discharge control of the first electrode array (1) and the second electrode array (2) includes independently regulating the electric pulse signals in the first electric field closed loop and the second electric field closed loop.

15. The method of controlling an electrode array device according to claim 11, wherein The at least one first surface electrode (11) connected as a positive terminal is uniformly distributed in the first electrode array (1), and the at least one first surface electrode (11) connected as a negative terminal is uniformly distributed in the first electrode array (1); And / or, the at least one second surface electrode (21) connected as a positive terminal is uniformly distributed in the second electrode array (2), and the at least one second surface electrode (21) connected as a negative terminal is uniformly distributed in the second electrode array (2).

16. The method of controlling an electrode array device according to claim 11, wherein The first electrode array (1) comprises a plurality of first surface electrodes (11) arranged alternately with positive and negative electrodes; the second electrode array (2) comprises a plurality of second surface electrodes (21) arranged alternately with positive and negative electrodes; all the first surface electrodes (11) with positive electrodes in the first electrode array (1) are connected in parallel to form a positive terminal of the first electrode array (1), and all the first surface electrodes (11) with negative electrodes in the first electrode array (1) are connected in parallel to form a negative terminal of the first electrode array (1); a first electric field closed loop is formed through the positive terminal and the negative terminal of the first electrode array (1); all the second surface electrodes (21) with positive electrodes in the second electrode array (2) are connected in parallel to form a positive terminal of the second electrode array (2), and all the second surface electrodes (21) with negative electrodes in the second electrode array (2) are connected in parallel to form a negative terminal of the second electrode array (2); a second electric field closed loop is formed through the positive terminal and the negative terminal of the second electrode array (2). Discharge control of the first electrode array (1) and the second electrode array (2) respectively comprises: independent regulation and control of the electric pulse signals in the first electric field closed loop and the second electric field closed loop respectively.

17. An electrode probe, characterized by The electrode array device is arranged on the top surface of the probe shell (3) and is used to contact human cell tissues; the electrode array device comprises a first electrode array (1) and a second electrode array (2) independently regulated and controlled in the inner and outer circles; the second electrode array (2) is located in the inner circle, and the first electrode array (1) is located in the outer circle; the first electrode array (1) comprises a plurality of first surface electrodes (11) arranged alternately with positive and negative electrodes; the second electrode array (2) comprises a plurality of second surface electrodes (21) arranged alternately with positive and negative electrodes.

18. The electrode probe of claim 17, wherein, The shapes of the first electrode array (1) and the second electrode array (2) are both center-symmetric figures, or the first electrode array (1) and the second electrode array (2) are concentric circle structures.

19. The electrode probe of claim 17, wherein, The probe shell (3) comprises a pressure assembly (31) and a handheld end (32), the handheld end (32) and the pressure assembly (31) constitute an internal cavity for accommodating a voltage control board; the pressure assembly (31) has a top surface for fixing the electrode array device; all first surface electrodes (11) with positive polarity in the first electrode array (1) are connected in parallel to form a positive terminal of the first electrode array (1), all first surface electrodes (11) with negative polarity in the first electrode array (1) are connected in parallel to form a negative terminal of the first electrode array (1), all second surface electrodes (21) with positive polarity in the second electrode array (2) are connected in parallel to form a positive terminal of the second electrode array (2), and all second surface electrodes (21) with negative polarity in the second electrode array (2) are connected in parallel to form a negative terminal of the second electrode array (2), the electrode array device has at least two pairs of positive and negative terminals, and the at least two pairs of positive and negative terminals are electrically connected to the voltage control board.

20. The electrode probe of claim 17, wherein, The first surface electrodes (11) and the second surface electrodes (12) on the electrode array device each have a convex surface for contacting human cell tissues, and the convex surface has a smooth outer edge and protrudes from the top surface.

21. The electrode probe of claim 17, wherein, The height difference between the convex surfaces of the first surface electrodes (11) and the second surface electrodes (12) and the top surface of the probe shell (3) is not greater than 0.5 mm.

22. The electrode probe of claim 17, wherein, The outer edges of the first surface electrodes (11) form an outer ring, and the outer edges of the second surface electrodes (21) form an inner ring, the outer diameter of the inner ring is 10-20 mm, and the outer diameter of the outer ring is 40-50 mm.

23. The electrode probe of claim 17, wherein, The number of the first surface electrodes (11) and the number of the second surface electrodes (21) are both even numbers, the first electrode array (1) comprises at least two pairs of first surface electrodes (11), and the second electrode array (2) comprises at least one pair of second surface electrodes (21).

24. The electrode probe of claim 17, wherein, The distance between adjacent first surface electrodes (11), the distance between adjacent second surface electrodes (21), and the distance between adjacent first surface electrodes (11) and second surface electrodes (21) are all greater than or equal to 1 mm and less than 5 mm.

25. The electrode probe of claim 17, wherein, The edges of the first surface electrodes (11) and the second surface electrodes (21) are all provided with a rounded structure; the first surface electrodes (11) are in a fan ring structure, the top edge of the fan ring structure is a rounded structure with a radius of not greater than 0.5 mm, and the side edge of the fan ring structure is a rounded structure with a radius of not greater than 1 mm; the second surface electrodes (21) are in a fan structure, the top edge of the fan structure is a rounded structure with a radius of not greater than 0.5 mm, and the side edge of the fan structure is a rounded structure with a radius of not greater than 1 mm.

26. The electrode probe of claim 17, wherein, Adjacent surface electrodes are filled with an insulating material, and / or adjacent surface electrodes are filled with an insulating material with a Shore hardness of not greater than 80.

27. The electrode probe of claim 26, wherein, The dielectric strength of the insulating material is not less than 3 kV / mm.

28. The electrode probe of any one of claims 17 to 27, wherein, The dielectric constant of the probe housing (3) is not less than 3.5, and / or the electrical conductivity of the first surface electrode (11) and the second surface electrode (21) is not less than 1 x 10 6 S / m.

29. An electrode tab, characterized by The electrode sheet comprises a stacked base layer, an adhesive layer, and a conductive layer, the conductive layer comprising at least one set of electrode array devices, each set of electrode array devices comprising a first electrode array (1) and a second electrode array (2) independently regulated by inner and outer rings; the second electrode array (2) is located in the inner ring, and the first electrode array (1) is located in the outer ring; the first electrode array (1) comprises a plurality of first surface electrodes (11) with positive and negative electrodes arranged alternately; the second electrode array (2) comprises a plurality of second surface electrodes (21) with positive and negative electrodes arranged alternately.

30. The electrode patch of claim 29, wherein, In each set of electrode array devices, all first surface electrodes (11) with positive attributes in the first electrode array (1) are connected in parallel to form a positive terminal of the first electrode array (1), all first surface electrodes (11) with negative attributes in the first electrode array (1) are connected in parallel to form a negative terminal of the first electrode array (1), all second surface electrodes (21) with positive attributes in the second electrode array (2) are connected in parallel to form a positive terminal of the second electrode array (2), and all second surface electrodes (21) with negative attributes in the second electrode array (2) are connected in parallel to form a negative terminal of the second electrode array (2), each set of electrode array devices has at least four electrode terminals for external voltage input; the positive terminals of the first electrode arrays (1) of all sets of electrode array devices are connected together to form a first positive electrode of the electrode sheet, the negative terminals of the first electrode arrays (1) of all sets of electrode array devices are connected together to form a first negative electrode of the electrode sheet, the positive terminals of the second electrode arrays (2) of all sets of electrode array devices are connected together to form a second positive electrode of the electrode sheet, and the negative terminals of the second electrode arrays (2) of all sets of electrode array devices are connected together to form a second negative electrode of the electrode sheet; the first positive electrode, the first negative electrode, the second positive electrode, and the second negative electrode respectively protrude from the conductive layer to form a fixing part for connecting external voltage input.

31. The electrode patch of claim 29, wherein, The shapes of the first electrode array (1) and the second electrode array (2) are both center-symmetric figures, or the first electrode array (1) and the second electrode array (2) are concentric circular structures.

32. The electrode patch of claim 29, wherein, In each set of electrode array devices, the outer edges of a plurality of first surface electrodes (11) constitute an outer ring, and the outer edges of a plurality of second surface electrodes (21) constitute an inner ring; the outer diameter of the inner ring is 10-20 mm, and the outer diameter of the outer ring is 40-50 mm.

33. The electrode patch of claim 29, wherein the conductive material is a conductive ink. The number of first surface electrodes (11) and the number of second surface electrodes (21) are both even numbers, the first electrode array (1) comprises at least two pairs of first surface electrodes (11), and the second electrode array (2) comprises at least one pair of second surface electrodes (21).

34. The electrode patch of claim 29, wherein, The distance between adjacent first surface electrodes (11), the distance between adjacent second surface electrodes (21), and the distance between adjacent first surface electrodes (11) and second surface electrodes (21) are all greater than or equal to 0.5 mm and less than 5 mm.

35. The electrode patch of claim 29, wherein, The edge corners of the first surface electrode (11) and the second surface electrode (21) are provided with a rounded structure; the first surface electrode (11) is a fan ring structure, the top surface corner of the fan ring structure is a rounded structure, the radius of the rounded structure is not greater than 0.5 mm, the side surface corner of the fan ring structure is a rounded structure, the radius of the rounded structure is not greater than 1 mm; the second surface electrode (21) is a fan-shaped structure, the top surface corner of the fan-shaped structure is a rounded structure, the radius of the rounded structure is not greater than 0.5 mm, the side surface corner of the fan-shaped structure is a rounded structure, the radius of the rounded structure is not greater than 1 mm; and / or, the electrical conductivity of the first surface electrode (11) and the second surface electrode (21) is not less than 1×10 6 S / m.

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