Radio frequency microneedle array control device and method and radio frequency microneedle therapeutic apparatus

Abstract

The invention discloses a radio frequency microneedle array control device, a radio frequency microneedle array control method and a radio frequency microneedle therapeutic apparatus. The input end of the switch switching circuit is connected with the power supply, and the first output end of the switch switching circuit is electrically connected with the microneedle array through the PCB; working modes stored in the main controller comprise a bipolar mode, under the bipolar mode, the electric polarity of at least one microneedle electrode in the microneedle array is opposite to the electric polarity of the other microneedle electrodes, and the main controller controls the switch switching circuit to be communicated with the power supply and the microneedle array. And the main controller controls the switch switching circuit to switch the electric polarity of each microneedle electrode of the microneedle array. The uniformity of energy distribution in a treatment area can be improved, meanwhile, the acting effect of the microneedles in the horizontal direction and the direction perpendicular to the skin is enhanced, and the treatment effect is further improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a radio frequency microneedle array control device, method and radio frequency microneedle therapeutic apparatus. Background Art

[0002] Radio frequency microneedle therapy is a minimally invasive radio frequency fractional technology. It uses fine microneedles to precisely apply radio frequency (RF) energy to target tissues at different depths, fundamentally changing the problems of traditional laser and radio frequency therapies such as uncertain treatment depth, difficult control of skin damage, and severe attenuation of energy transmission. At the same time, it avoids the occurrence of side reactions such as pigmentation, and can be used for facial rejuvenation applications such as skin tightening and scar removal, and can also be used for acne treatment and axillary hyperhidrosis treatment.

[0003] However, there are still many problems in the current microneedle fractional radio frequency treatment process. For example, the fixed polarity leads to uneven energy distribution. In the traditional bipolar mode, the polarity of the microneedle electrode is usually fixed, that is, the same microneedle electrode always acts as the positive or negative electrode during the treatment process. This design with fixed polarity will result in uneven energy distribution within the treatment area. Excessive energy in some areas may cause tissue damage, while insufficient energy in some areas will affect the treatment effect. There is a lack of a dynamic polarity switching mechanism. In the prior art, the polarity switching of the microneedle electrode usually depends on manual adjustment or preset modes, and cannot dynamically adjust the electrode polarity according to real-time feedback during the treatment process (such as tissue impedance changes). This static switching method is difficult to adapt to the tissue characteristic differences in different treatment areas, restricting the treatment effect and safety.

[0004] Therefore, there is an urgent need for a radio frequency microneedle treatment technology that can dynamically switch the polarity of the microneedle electrode and improve the uniformity of energy distribution to further enhance the treatment effect and safety. Summary of the Invention

[0005] The main object of the present invention is to propose a radio frequency microneedle array control device, method and radio frequency microneedle therapeutic apparatus, aiming to realize a radio frequency microneedle treatment technology that can dynamically switch the polarity of the microneedle electrode and improve the uniformity of energy distribution.

[0006] To achieve the above object, the present invention proposes a radio frequency microneedle array control device, and the radio frequency microneedle array control device includes:

[0007] A power supply;

[0008] A microneedle array, including a PCB board and a plurality of microneedle electrodes arranged on the PCB board;

[0009] A switch switching circuit, the input end of the switch switching circuit is connected to the power supply, and the first output end of the switch switching circuit is electrically connected to the microneedle array through the PCB board;

[0010] A main controller, wherein the working modes stored in the main controller include a bipolar mode. In the bipolar mode, the electrode polarities of at least one of the microneedle electrodes in the microneedle array are opposite to those of the remaining microneedle electrodes. The main controller controls the switch switching circuit to connect the power supply and the microneedle array, and the main controller controls the switch switching circuit to switch the electrode polarities of the microneedle electrodes in the microneedle array.

[0011] Optionally, in the bipolar mode, the microneedle electrodes of the microneedle array are switched at least once at the power supply end through switch control.

[0012] Optionally, the working modes stored in the main controller further include a unipolar mode. In the unipolar mode, the electrode polarities of multiple microneedle electrodes in the microneedle array are the same. The main controller controls the switch switching circuit to connect the power supply, the microneedle array and the return electrode;

[0013] The main controller is used to control the switch switching circuit to work so as to control the microneedle array to switch between the unipolar mode and the bipolar mode.

[0014] Optionally, the main controller is used to control the switch switching circuit to work so as to control the microneedle array to switch between the unipolar mode and the bipolar mode at least once during a treatment process, or control the microneedle array to switch between the unipolar mode and the bipolar mode at a preset period.

[0015] Optionally, the power supply includes:

[0016] Multiple independent radio frequency power supplies, and the radio frequency power supplies are connected to the switch switching circuit.

[0017] Optionally, an impedance detection circuit is further included. The impedance detection circuit is connected to each microneedle electrode in the microneedle array, and the output end of the impedance detection circuit is connected to the main controller. The main controller is further used to control the corresponding radio frequency power supply to adjust the output according to the feedback of the detected impedance so as to ensure uniform energy between treatment areas.

[0018] The present invention also provides a radio frequency microneedle array control method, which is applied to a radio frequency microneedle array control device, wherein the radio frequency microneedle array control device includes:

[0019] A power supply;

[0020] A microneedle array, including a PCB board and multiple microneedle electrodes arranged on the PCB board;

[0021] A switch switching circuit, the input end of the switch switching circuit is connected to the power supply, and the first output end of the switch switching circuit is electrically connected to the micro-needle array through the PCB board; the radio frequency micro-needle array control method includes:

[0022] In the bipolar mode, control the switch switching circuit to connect the power supply and the micro-needle array, and control the switch switching circuit to switch the electrode polarities of the micro-needle electrodes of the micro-needle array; wherein, in the bipolar mode, the electrode polarities of at least one of the micro-needle electrodes in the micro-needle array are opposite to those of the remaining micro-needle electrodes.

[0023] Optionally, the step of controlling the switch switching circuit to switch the electrode polarities of the micro-needle electrodes of the micro-needle array includes:

[0024] After the micro-needle array works continuously for a period of time, control the micro-needle electrodes of the micro-needle array to perform a power supply terminal switch through a switch control.

[0025] Optionally, the radio frequency micro-needle array control method further includes:

[0026] Obtain the impedance value between the positive and negative electrodes of the micro-needle electrode and a preset impedance threshold;

[0027] According to the obtained impedance value between the positive and negative electrodes of the micro-needle electrode and the preset impedance threshold, control the radio frequency energy output of the power supply.

[0028] Optionally, the step of controlling the radio frequency energy output of the power supply according to the obtained impedance value between the positive and negative electrodes of the micro-needle electrode and the preset impedance threshold specifically includes:

[0029] When the impedance value between the positive and negative electrodes of the micro-needle obtained continues to increase and is greater than the preset impedance threshold, control the power supply to reduce the radio frequency energy output.

[0030] The present invention also provides a radio frequency micro-needle treatment instrument, including the radio frequency micro-needle array control device as described above, and further including:

[0031] A housing, one end of the housing is provided with an opening;

[0032] A driving mechanism, installed in the housing;

[0033] A heat conduction cooling component, installed in the housing, and the heat conduction cooling component is connected to the driving mechanism. The driving mechanism is used to drive the heat conduction cooling component to move, so as to drive the micro-needle array to extend out of the housing or move back into the housing through the opening. The heat conduction cooling component is used for refrigeration and cooling the micro-needle array.

[0034] Optionally, the driving mechanism includes a driving member, a transmission member, and a driving rod. The driving member is drivingly connected to the driving rod through the transmission member. The heat conduction component is connected to the driving rod. A pressure sensor is provided at an end of the driving rod facing the heat conduction component for providing pressure feedback to adjust the power of the driving member.

[0035] Optionally, the heat conduction component includes a heat dissipation device and a refrigeration device. The refrigeration device is a thermoelectric cooler, including a hot end and a cold end arranged in a stacked manner. An insulating layer is provided between the cold end and the PCB board, and a temperature sensor is provided in the insulating layer for detecting the temperature of the micro-needle electrode.

[0036] The radio frequency micro-needle array control device of the present invention is provided with a power supply, a return electrode, and a micro-needle array. In the monopolar mode, the main controller is used to control the switch switching circuit to connect the power supply, the micro-needle array, and the return electrode. Among them, the electrode polarities of multiple micro-needle electrodes in the micro-needle array are the same. In the bipolar mode, the main controller is used to control the switch switching circuit to connect the power supply and the micro-needle array. Among them, the electrode polarity of at least one micro-needle electrode in the micro-needle array is opposite to that of the remaining micro-needle electrodes. The present invention can improve the uniformity of the energy distribution in the treatment area, and at the same time enhance the action effect of the micro-needles in the horizontal direction and the vertical skin direction, further improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.

[0038] Figure 1 It is a schematic circuit structure diagram of an embodiment of the radio frequency micro-needle array control device of the present invention;

[0039] Figure 2 For Figure 1 It is a schematic diagram of the electrode arrangement of an embodiment of the micro-needle array in

[0040] Figure 3 It is a schematic flowchart of an embodiment of the radio frequency micro-needle array control method of the present invention;

[0041] Figure 4 It is a schematic flowchart of an embodiment of the radio frequency micro-needle array control method of the present invention;

[0042] Figure 5 It is a schematic structural diagram of an embodiment of the radio frequency micro-needle therapeutic instrument of the present invention.

[0043] Description of the attached drawing reference numerals:

[0044] Label Name Label Name 10 Power supply 40 Switching circuit 20 Return electrode 50 Main controller 30 Microneedle array 100 Housing 200 Driving mechanism 110 Port 211 Encoder 210 Driver 230 Drive rod 220 Transmission rod 300 Thermal conduction component 231 Pressure sensor 320 Refrigeration device 310 Heat dissipation device 322 Cold end 321 Hot end 410 PCB board 400 Microneedle component 430 Insulating layer 420 Microneedle 431 Temperature sensor

[0045] The realization, functional features and advantages of the object of the present invention will be further described with reference to the embodiments and the accompanying drawings. Detailed implementation manners

[0046] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0047] It should be noted that if there are directional indications (such as up, down, left, right, front, back,...) involved in the embodiments of the present invention, then such directional indications are only used to explain the relative positional relationship and movement conditions between components in a specific posture (as shown in the accompanying drawings). If the specific posture changes, then the directional indications will also change accordingly.

[0048] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present invention, then such descriptions of "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present invention.

[0049] The term "and / or" in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the character " / " in this article generally represents an "or" relationship between the associated objects before and after.

[0050] The present invention provides a radio frequency micro-needle array control device.

[0051] Refer to Figure 1 , in an embodiment of the present invention, the radio frequency micro-needle array 30 control device includes:

[0052] A power supply 10;

[0053] Return electrode 20;

[0054] The microneedle array 30 includes a PCB board and a plurality of microneedle electrodes 420 disposed on the PCB board;

[0055] A switch switching circuit 40, wherein an input end of the switch switching circuit 40 is connected to the power supply 10, two first output ends of the switch switching circuit 40 are electrically connected to the microneedle array 30 through a PCB board, and a second output end of the switch switching circuit 40 is electrically connected to the return electrode 20;

[0056] A main controller 50, wherein the main controller 50 has a monopolar mode and a bipolar mode. In the monopolar mode, the main controller 50 controls the switch circuit 40 to connect the power supply 10, the microneedle array 30 and the return electrode 20; wherein the electrical polarity of the plurality of microneedle electrodes 420 in the microneedle array 30 is the same;

[0057] In the bipolar mode, the main controller 50 controls the switch circuit 40 to connect the power supply 10 and the microneedle array 30 ; wherein the electrical polarity of at least one of the microneedle electrodes 420 in the microneedle array 30 is opposite to the electrical polarity of the remaining microneedle electrodes 420 .

[0058] In this embodiment, the material of the microneedle electrode 420 can be selected from any conductive metal or other conductive material, such as stainless steel, gold, silver, platinum, platinum-iridium alloy, tungsten, etc., and the surface material of the microneedle electrode 420 is a material with good biocompatibility, such as 304 stainless steel, 316 stainless steel, gold, platinum, platinum-iridium alloy, etc. The entire microneedle array 30 has at least one microneedle with polarity opposite to that of other microneedles, that is, the microneedle array 30 has both positive and negative electrodes. The microneedle electrodes 420 on the microneedle array 30 can be set as positive electrodes or negative electrodes as needed, and the electrodes of each microneedle can be switched, and alternately serve as positive and negative electrodes in turn in different operating time periods. The microneedle electrode 420 is not fixed in the alternating position of the positive and negative electrodes, which avoids the same microneedle electrode 420 always acting as a positive electrode or a negative electrode during the application process. Specifically, it can be achieved by passing voltages of different polarities on each microneedle. The polarity of the electrodes of each microneedle can be the same as or different from that of the electrodes of the adjacent microneedles. For example, the electrodes of the microneedle array 30 can be arranged in rows (columns) in a staggered manner, that is, the electrodes of the microneedles in one row (column) are arranged as positive electrodes, and the electrodes of the microneedles in the adjacent row (column) are arranged as negative electrodes. Figure 2As shown, the electrodes of each microneedle are opposite to those of its adjacent microneedles, that is, the microneedle electrodes 420 in each row and each column are arranged in a positive and negative alternating manner. The PCB board can be used to install the microneedle array 30, which can be a PCB board or the mounting substrate of the microneedle array 30. In one embodiment, the control device of the radio frequency microneedle array 30 further includes a driving structure provided with a motor. The driving structure can drive the PCB board to move, and then drive the microneedle array 30 to move. The microneedle array 30 can penetrate into the skin, and after reaching the specified depth, the microneedle tips start to release radio frequency energy for radio frequency treatment.

[0059] The output frequency of the power supply 10 can be 0.3 MHz - 100 MHz, and the power supply 10 can be a continuous output power supply or a pulse output power supply or a power supply that outputs continuously and in pulses simultaneously. The power supply 10 can be an external power supply or a rechargeable lithium battery. A power management chip and a rechargeable battery can be provided in the power supply 10. The output voltage of the power supply 10 is controllable. For example, the main controller 50 can output different control signals to the power supply 10, so that the power supply 10 outputs a pulsed voltage. The power supply 10 can be logically connected to the main controller 50 through the power management chip, so as to realize functions such as charging management, discharging management, and power consumption management through the power management chip, as well as the switching and selection of the discharging mode, constant power discharging or pulsed discharging.

[0060] Furthermore, the number of the power supplies 10 can be one or multiple. When multiple power supply units are provided, the multiple power supply units are respectively connected to the switch switching circuit;

[0061] Microneedle treatment generally realizes constant power output through impedance detection feedback. In this embodiment, an impedance detection circuit is also provided. The impedance detection circuit is connected to each microneedle electrode in the microneedle array. The output end of the impedance detection circuit is connected to the main controller. The main controller 50 is also used to control the power supply unit to provide corresponding supply voltages to the corresponding microneedle electrodes according to the positive and negative impedance of each microneedle electrode detected by the impedance detection circuit.

[0062] The impedance detection circuit detects the impedance between the positive and negative microneedle electrodes 420, and its output end is electrically connected to the main controller 50. The main controller 50 can also control the independent radio frequency power supply or each power supply unit to work according to the data fed back by the impedance sensor, so as to adjust the RF output power of the microneedle electrode 420.

[0063] In the monopolar mode, in the embodiment where the power supply 10 is provided with a single power independent radio frequency power supply, the main controller 50 can control the independent radio frequency power supply according to the data fed back by the impedance sensor to adjust the RF output power of the overall microneedle electrodes 420 of the microneedle array, so as to ensure that the total output power is constant.

[0064] In an embodiment where the power supply 10 is set to multiple independent radio frequency power supplies, a separate independent radio frequency power supply can be provided for each micro-needle electrode 420 (in bipolar mode, each pair of micro-needle electrodes). Each micro-needle electrode is provided with an impedance sensor to detect the impedance of each micro-needle electrode 420 and adjust the output power according to the impedance, so as to ensure that the output power of each needle is the same. A grouped power supply method is adopted, that is, each group of micro-needle electrodes 420 is powered by an independent radio frequency power supply. The main controller 50 controls the corresponding power supply unit to adjust the output (adjust the frequency or pulse width or voltage amplitude) according to the feedback of the detected impedance. The purpose of using multiple independent power supplies in this embodiment is for precise control to ensure uniform energy between treatment areas.

[0065] In bipolar mode, the impedance between the positive and negative micro-needle electrodes 420 of each group of the micro-needle array 30 can be detected, and the output power can be adjusted according to the impedance between the positive and negative micro-needle electrodes 420 of each group. Specifically, the micro-needle array 30 can be set to multiple electrode pairs, and the voltage of each electrode pair is adjustable. Correspondingly, the number of power supplies 10 can be set to multiple, and each electrode pair is correspondingly provided with one of the power supplies 10; alternatively, the power supply 10 is provided with multiple output terminals and multiple control switches (not shown in the figure), and each output terminal and control switch are connected to one electrode pair; when each control switch is closed, it supplies power to the corresponding electrode pair. The power supply 10 of this embodiment can be provided with multiple independent power supply units, and one power supply unit supplies power to one electrode pair. Alternatively, one power supply 10 is provided, and the power supply 10 can be provided with multiple output terminals. One output terminal and one control switch correspond to one electrode pair. When it is necessary to supply power to a certain electrode pair, the conduction degree, conduction frequency, etc. of the control switch corresponding to the electrode pair can be controlled to adjust the frequency or pulse width or voltage amplitude output to the micro-needle electrode 420. Of course, in other embodiments, the micro-needles can also be set to multiple electrode groups. Each electrode group includes the same number of positive micro-needle electrodes 420 and negative micro-needle electrodes 420. The micro-needles are grouped and powered by the power supply 10, and each micro-needle is arranged alternately, so that multiple micro-needle electrodes 420 can be arranged at an appropriate density on a limited target plane, and the spacing distance between adjacent micro-needle electrodes 420 is ensured to prevent the proximity effect. In bipolar mode, the method of using multiple independent radio frequency power supplies can be adopted, so that the temperature of the thermal diffusion area of each group of micro-needles can be precisely controlled, and a better treatment effect can be achieved.

[0066] The main controller 50 can be a microprocessor such as a single-chip microcomputer, DSP, or FPGA. Of course, in some embodiments, it can also be implemented using a dedicated chip for the radiofrequency microneedle therapeutic instrument, and there is no limitation here. Those skilled in the art can integrate some hardware circuits and software programs or algorithms in the main controller 50, connect various parts of the entire radiofrequency microneedle array 30 control device through various interfaces and lines, execute various functions of the radiofrequency microneedle array control device and process data by running or executing the software programs and / or modules in the main controller 50, and calling the data in the main controller 50, so as to perform overall monitoring of the radiofrequency microneedle array control device. A variety of working modes are stored in the main controller 50, and can be specifically selected and switched according to the needs of the user. The working modes include a monopolar mode and a bipolar mode. In the bipolar mode, it can also include the switching period and duration of each electrode polarity. The user can also select a custom mode or a preset mode. The preset mode can set different working frequencies, voltage pulses, and electrode energization working durations of the microneedles according to statistics, research, or empirical values, etc., and then form different options for the user to choose. The custom setting is that the user sets the working duration of the microneedles and the working voltage of the microneedles according to their own needs.

[0067] Among them, the main controller 50 can specifically control the switch switching circuit 40 to work to control the microneedle array 30 to switch between the monopolar mode and the bipolar mode. And during a treatment process, control the microneedle array 30 to switch between the monopolar mode and the bipolar mode at least once. Or, the main controller 50 can also control the switch switching circuit 40 to work to control the microneedle array 30 to switch between the monopolar mode and the bipolar mode at a preset period. In a specific embodiment, the duration T of a treatment in the treatment stage can be set in the range of 10 ms to 12 s, and in each of the two working modes of the monopolar mode and the bipolar mode, the duration T1 can be in the range of 5 ms to 5 s.

[0068] The control device for the radio frequency micro-needle array 30 of the present invention is provided with a power supply 10, a return electrode 20, and a micro-needle array 30; in the monopolar mode, the main controller 50 controls the switch switching circuit 40 to connect the power supply 10, the micro-needle array 30, and the return electrode 20; wherein, the electrode polarities of multiple micro-needle electrodes 420 in the micro-needle array 30 are the same; in the bipolar mode, the main controller 50 controls the switch switching circuit 40 to connect the power supply 10 and the micro-needle array 30; wherein, the electrode polarity of at least one micro-needle electrode 420 in the micro-needle array 30 is opposite to that of the remaining micro-needle electrodes 420. The control device for the radio frequency micro-needle array 30 of the present invention can realize the switching between single and double electrodes of the micro-needles, so that the action area of the micro-needles has better treatment effects in both the width in the horizontal direction and the depth in the vertical skin direction, which is beneficial to improving the energy output uniformity.

[0069] Referring to Figure 1 , in an embodiment, when controlling the switch switching circuit 40 to work, the main controller 50 switches the electrodes of each micro-needle electrode 420 in the micro-needle array 30 at least once.

[0070] Based on the control of the main controller 50, the switch switching circuit 40 is used to connect the positive and negative power supplies of the power supply 10 to the micro-needle electrode 420, so that the micro-needle electrode 420 works as a positive electrode or a negative electrode. In the monopolar mode, the polarities of the electrodes in the micro-needle array 30 are the same, for example, all are positive electrodes. At this time, under the control of the switch switching circuit 40, the power supply 10 provides positive power to each electrode of the micro-needle array 30, and the negative electrode of the power supply 10 is connected to the return electrode 20 under the control of the switch switching circuit 40. When the radio frequency micro-needle array 30 control device is working, the return electrode 20 is attached to the human body surface, and forms a conduction loop with the power supply 10, the micro-needle electrode 420 of the micro-needle array 30, the switch switching circuit 40, and the human body (when treating the face, the return electrode 20 is generally attached to the back of the neck, and when treating the abdomen, it is generally attached to the back).

[0071] In the bipolar mode, the switch switching circuit 40 introduces the power supply 10 to the microneedle array 30, and under the control of the switch switching circuit 40, the positive and negative poles of the power supply 10 are respectively connected to each microneedle electrode 420. There is at least one negative microneedle electrode 420 in the microneedle array 30, and the remaining microneedle electrodes 420 can be all or partially set as positive microneedle electrodes 420. Or, there is at least one positive microneedle electrode 420, and the remaining microneedle electrodes 420 can be all or partially set as negative microneedle electrodes 420. The main controller 50 controls the switch switching circuit 40 to switch the electrodes of each microneedle electrode 420 of the microneedle array 30, that is, the polarities of the respective microneedle electrodes 420 can be switched. For example, after the microneedle array 30 has been continuously operating for a period of time Tˊ, all the microneedles of the microneedle array 30 perform a power supply terminal switch through switch control (the two ports A and B of the power supply 10, the microneedles connected to port A are switched to be connected to port B, and at the same time the microneedles connected to port B are switched to be connected to port A). Each time in the bipolar mode, the power supply terminal is switched at least once. For the microneedles connected to both ends of the RF power supply in the bipolar mode, the corresponding heat diffusion regions will be different, mainly caused by the power supply characteristics. As a result, the heat diffusion region will be uneven, which will affect the treatment effect. The above influence can be eliminated by switching the power supply terminal.

[0072] The switch switching circuit 40 can also control the microneedle array 30 to switch between the monopolar mode and the bipolar mode. Specifically, during treatment, the initial working mode can be the monopolar mode or the bipolar mode. After a period of time T1, the working mode is switched, that is, from the monopolar mode to the bipolar mode, or from the bipolar mode to the monopolar mode. The working mode is switched at least once during the entire treatment stage. The action regions (heat diffusion regions) in the two modes are different. The depth of the action region in the monopolar mode is deeper than that in the bipolar mode. The action region in the bipolar mode is mainly between two needles with opposite polarities and is relatively wide in the horizontal direction. In order to expand the action region and improve the treatment effect, the present embodiment adopts a mode of switching between monopolar and bipolar, so that the width of the action region in the horizontal direction and the depth in the vertical skin direction reach the expected effect.

[0073] The present invention also proposes a method for controlling an RF microneedle array, which is applied to the microneedle electrode array device as described above. The RF microneedle array control device includes:

[0074] A power supply;

[0075] A return electrode;

[0076] A microneedle array, including a PCB board and a plurality of microneedle electrodes arranged on the PCB board;

[0077] A switch switching circuit, an input end of the switch switching circuit is connected to the power supply, two first output ends of the switch switching circuit are electrically connected to the micro-needle array through a PCB board, and a second output end of the switch switching circuit is electrically connected to the return electrode;

[0078] Referring to Figure 3 , the radio frequency micro-needle array control method includes:

[0079] Step S100, in the monopolar mode, control the switch switching circuit to connect the power supply, the micro-needle array and the return electrode; wherein, the electrode polarities of multiple micro-needle electrodes in the micro-needle array are the same;

[0080] Step S200, in the bipolar mode, control the switch switching circuit to connect the power supply and the micro-needle array; wherein, the electrode polarity of at least one micro-needle electrode in the micro-needle array is opposite to that of the remaining micro-needle electrodes. In this embodiment, the switch switching circuit is controlled by the main controller and is used to connect the positive and negative power supplies of the power supply to the micro-needle electrodes, so that the micro-needle electrodes work as positive or negative electrodes. In the monopolar mode, the polarities of the electrodes in the micro-needle array are the same, for example, all are positive electrodes. At this time, under the control of the switch switching circuit, the power supply provides positive power to each electrode of the micro-needle array, and the negative electrode of the power supply is connected to the return electrode under the control of the switch switching circuit. When the radio frequency micro-needle array control device is working, the return electrode is attached to the human body surface, and forms a conduction loop with the power supply, the micro-needle electrodes of the micro-needle array, the switch switching circuit, and the human body (when treating the face, the return electrode is generally attached to the back of the neck, and when treating the abdomen, it is generally attached to the back).

[0081] In the bipolar mode, the switch switching circuit introduces the power supply to the micro-needle array, and under the control of the switch switching circuit, the positive and negative electrodes of the power supply are respectively connected to each micro-needle electrode. There is at least one negative micro-needle electrode in the micro-needle array, and the remaining micro-needle electrodes can be all or part of them set as positive micro-needle electrodes. Or, there is at least one positive micro-needle electrode, and the remaining micro-needle electrodes can be all or part of them set as negative micro-needle electrodes. The main controller controls the switch switching circuit to switch the electrodes of each micro-needle electrode in the micro-needle array, that is, the polarities of each micro-needle electrode can be switched. For example, after the micro-needle array works continuously for a period of time Tˊ, all the micro-needles of the micro-needle array are switched at the power supply end through switch control (two ports A and B of the power supply, the micro-needles connected to port A are switched to be connected to port B, and at the same time the micro-needles connected to port B are switched to be connected to port A). Each time in the bipolar mode, the power supply end is switched at least once. In the bipolar mode, for the micro-needles connected to both ends of the radio frequency power supply, the corresponding heat diffusion areas will be different, mainly caused by the power supply characteristics. As a result, the heat diffusion area will be uneven, which will affect the treatment effect. The above influence can be eliminated by switching the power supply end.

[0082] In one embodiment, the radio frequency microneedle array control method further includes:

[0083] Step S300: Control the microneedle array to switch between the monopolar mode and the bipolar mode at least once;

[0084] Step S400: When controlling the microneedle array to work in the bipolar mode, control the switch switching circuit to switch the electrodes of each microneedle electrode of the microneedle array.

[0085] The switch switching circuit can also control the microneedle array to switch between the monopolar mode and the bipolar mode. Specifically, during treatment, the initial working mode can be the monopolar mode or the bipolar mode. After a period of time T1, the working mode is switched, that is, switched from the monopolar mode to the bipolar mode, or from the bipolar mode to the monopolar mode. The working mode is switched at least once during the entire treatment stage. The action areas (thermal diffusion areas) in the two modes are different. The depth of the action area in the monopolar mode is deeper than that in the bipolar mode. The action area in the bipolar mode is mainly between two needles with opposite polarities and is relatively wide in the horizontal direction. In order to expand the action area and improve the treatment effect, this embodiment adopts a single-bipolar switching mode, so that the width of the action area in the horizontal direction and the depth in the vertical skin direction reach the expected effect.

[0086] In one embodiment, the radio frequency microneedle array control method further includes:

[0087] Step S500: Obtain the impedance value of the tissue between the positive and negative electrodes of the microneedle and a preset impedance threshold;

[0088] In this embodiment, an impedance sensor can be arranged on the microneedle electrode to detect the impedance between the positive and negative microneedle electrodes. For example, in the bipolar mode, an impedance sensor is arranged for each microneedle electrode pair to detect the impedance between each microneedle electrode. Among them, the preset impedance threshold can be obtained through the following steps:

[0089] After the microneedle electrode penetrates the skin and reaches the preset depth, obtain the current impedance value of the tissue between the positive and negative electrodes of the microneedle;

[0090] According to the obtained current impedance value of the tissue between the positive and negative electrodes of the microneedle, calculate the preset impedance threshold.

[0091] The radio frequency microneedle array control device further includes a driving structure provided with a motor. The driving structure can drive the PCB board to move, and then drive the microneedle array to move. The microneedle array can penetrate into the skin, and after reaching the specified depth, the microneedle tips start to release radio frequency energy for radio frequency treatment.

[0092] According to the different working modes of the radiofrequency microneedle array control device, the initial impedance value when the microneedles penetrate is also different. In the initial stage of microneedle treatment, the microneedle electrodes are controlled to penetrate the skin, and after reaching the preset depth, the initial impedance values in the monopolar mode and bipolar mode can be obtained through the impedance sensor and mode switching respectively. For example, in the monopolar mode, the initial impedance value is Z1, and in the bipolar mode, the initial impedance value is Z2. According to the obtained initial impedance values, preset impedance thresholds are set: in the monopolar mode, the impedance threshold is k1×Z1 + A, and in the bipolar mode, the impedance threshold is k2×Z2 + B, where k1, k2, A, and B are constants preset according to experimental data.

[0093] Step S600: Control the RF energy output of the power supply according to the impedance value of the tissue between the positive and negative microneedle electrodes obtained and the preset impedance threshold. Specifically:

[0094] When the impedance value of the tissue between the positive and negative microneedle electrodes obtained continues to increase and is greater than the preset impedance threshold, control the power supply to reduce the RF energy output.

[0095] In this embodiment, when the radiofrequency microneedle array control device is powered on and working, after the microneedle electrodes penetrate the skin and reach the preset depth, and the initial impedance value when the microneedles penetrate is obtained, the power supply output parameters can be determined according to the obtained initial impedance value, and then start to output RF energy, where the correspondence between the power supply output and the impedance value is preset in the system. During the treatment process of the radiofrequency microneedle array control device, the impedance of the tissue in the treatment area changes linearly with the increase of temperature. First, it gradually decreases and then gradually increases. After reaching a certain temperature, the impedance will increase sharply. At this time, the impedance sensor can be used to obtain the impedance value of the tissue between the positive and negative microneedle electrodes during the treatment process. When it is detected that the impedance gradually increases and reaches the preset impedance threshold, the RF energy output is reduced, otherwise the current RF energy output is maintained. In this way, the independent radiofrequency power supply can be controlled according to the feedback data of the impedance sensor to adjust the RF output power of the overall microneedle electrodes of the microneedle array, so as to ensure safety and treatment effect.

[0096] The present invention also proposes a radiofrequency microneedle therapeutic apparatus, including the radiofrequency microneedle array control device as described above. The detailed structure of the radiofrequency microneedle array control device can refer to the above embodiment and will not be elaborated here; it can be understood that since the above radiofrequency microneedle array control device is used in the radiofrequency microneedle therapeutic apparatus of the present invention, therefore, the embodiments of the radiofrequency microneedle therapeutic apparatus of the present invention include all the technical solutions of all the above embodiments of the radiofrequency microneedle array control device, and the achieved technical effects are also exactly the same, which will not be elaborated here.

[0097] Among them, the radiofrequency microneedle therapeutic apparatus includes:

[0098] A housing 100, one end of the housing 100 is provided with a through opening 110;

[0099] A driving mechanism 200, mounted on the housing 100;

[0100] A heat conduction component 300, mounted inside the housing 100, and the heat conduction component 300 is connected to the driving mechanism 200; and,

[0101] A microneedle assembly 400, connected to one side of the heat conduction component 300 facing the through opening 110, the heat conduction component 300 is used for refrigeration and cooling the microneedle assembly 400, and the driving mechanism 200 is used for driving the heat conduction component 300 to move, so as to drive the microneedle assembly 400 to extend out of the housing 100 through the through opening 110 or move back into the housing 100.

[0102] Specifically, the microneedle assembly 400 includes a PCB board and a microneedle array. The microneedle array is provided with a plurality of microneedles. Each microneedle electrode 420 is electrically connected to the PCB board 410. Alternatively, the microneedle array can also be welded to the PCB board. Each microneedle electrode 420 can be used to generate a radio frequency current (a high-frequency alternating current changing electromagnetic wave), so that RF energy acts on human tissues. In the related art, during the treatment process, since the radio frequency current continuously passes through the microneedles, the microneedles heat up and the heated microneedles will cause adhesion between the human tissues and them. In this way, unnecessary damage will be caused to the human tissues and the subsequent treatment effect will be affected.

[0103] The driving mechanism 200 is drivingly connected to the heat conduction component 300 to drive the heat conduction component 300 to move, so as to drive the microneedle assembly 400 to extend out of the housing 100 through the through opening 110 of the housing 100 or move back into the housing 100. When the microneedle assembly 400 extends out of the housing 100, its microneedle array can pierce into the skin and release RF energy after reaching the specified depth for radio frequency treatment. At the same time, during the radio frequency treatment process, the heat conduction component 300 can perform refrigeration to cool the microneedle assembly 400 connected to it, so as to effectively avoid the situation of adhesion between the human tissues and the microneedle electrodes 420 caused by the heating of the microneedle electrodes 420, avoid unnecessary damage to the human tissues, and further reduce the pain of the patient and improve the treatment effect and safety.

[0104] Further, as Figure 4As shown, the heat conduction component 300 includes a heat dissipation device 310 and a refrigeration device 320. The driving mechanism 200 is drivingly connected to the heat dissipation device 310. The refrigeration device 320 is connected to the heat dissipation device 310, and the microneedle assembly 400 is connected to the refrigeration device 320. It can be understood that the refrigeration device 320 is used for refrigeration and heat exchange with the microneedle assembly 400, so as to achieve the purpose of cooling the microneedle assembly 400. In addition, according to the law of conservation of energy, the refrigeration device 320 will also dissipate heat while generating cold. Therefore, in this embodiment, a heat dissipation device 310 is provided in the housing 100 to dissipate heat from the refrigeration device 320. Of course, in other embodiments, the heat dissipation device 310 may not be provided in the housing 100, and the refrigeration device 320 dissipates heat naturally by contacting the air.

[0105] In this embodiment, the heat dissipation device 310 includes a heat-conducting outer shell and a coolant. The heat-conducting outer shell encloses a liquid storage chamber, and the coolant is contained in the liquid storage chamber. Optionally, the heat-conducting outer shell can be made of a metal material with good heat conduction such as compressed aluminum, and the coolant can be brine or other liquids. It can be understood that this heat dissipation device 310 is essentially an energy storage device, which is used to temporarily store the heat conducted from the refrigeration device 320, and at the same time, the heat in the energy storage device will slowly dissipate into the air. In other embodiments, the heat dissipation device 310 can also use a fan and / or a radiator for heat dissipation, but this heat dissipation method will generate relatively large noise.

[0106] In this embodiment, as Figure 4 shown, the refrigeration device 320 is a thermoelectric cooler. The thermoelectric cooler includes a hot end 321 and a cold end 322 arranged in a stacked manner. The hot end 321 is connected to the heat dissipation device 310, and the microneedle assembly 400 is connected to the cold end 322. A thermoelectric cooler refers to a device that uses the thermoelectric effect of semiconductors to produce cold. Specifically, two different metals are connected by a conductor, and direct current is applied. Then, the temperature at one contact point decreases, and this contact point is the cold end 322; the temperature at the other contact point increases, which is called the hot end 321. Through the technical solution of this embodiment, by connecting the microneedle assembly 400 to the cold end 322 of the thermoelectric cooler, the heat of the microneedle electrode 420 in the microneedle assembly 400 can be conducted to the cold end 322, thereby reducing the temperature of the microneedle electrode 420. Of course, in other embodiments, other refrigeration devices 320 can also be used, such as heat exchangers, etc. However, as the refrigeration device 320, the thermoelectric cooler has the advantages of simple structure, small volume, and fast refrigeration, which is beneficial to reducing the overall volume of the radiofrequency microneedle therapeutic apparatus.

[0107] As known from the foregoing description, the microneedle assembly 400 includes an electrically connected PCB board 410 and a microneedle array, and the microneedle array is mounted on the PCB board 410. Among them, it is worth noting that the microneedle array should be arranged corresponding to the through port 110 so as to extend out of the housing 100 or move back into the housing 100 through the through port 110. In addition, the microneedle assembly 400 further includes an insulating layer 430, and the insulating layer 430 is provided between the cold end 322 and the PCB board 410. Specifically, the microneedle array penetrates through the PCB board 410 and is connected to the insulating layer 430. It can be understood that the insulating layer 430 can conduct the heat of the microneedle array to the cold end 322, and at the same time can prevent conductive contact between the microneedle array and the cold end 322. The insulating layer can be made of a material with a relatively high thermal conductivity, such as ceramics, to achieve this.

[0108] Furthermore, as Figure 1 shown, a temperature sensor 431 is also installed in the insulating layer 430, and the temperature sensor 431 is electrically connected to the central control unit of the radiofrequency microneedle therapeutic instrument. Among them, the central control unit can be the main controller in the radiofrequency microneedle array control device, or the CPU in the radiofrequency microneedle therapeutic instrument. The main controller in the radiofrequency microneedle array control device can also be the CPU in the radiofrequency microneedle therapeutic instrument.

[0109] It can be understood that the temperature sensor 431 is used to detect the temperature of the microneedle electrode 420 and convert the detected temperature into an electrical signal and feedback it to the central control unit of the radiofrequency microneedle therapeutic instrument, so that the central control unit can monitor the temperature of the microneedle electrode 420 in real time. Specifically, first, the temperature value of the microneedle electrode 420 is obtained through the temperature sensor 431. The central control unit judges whether the temperature of the microneedle electrode 420 exceeds the preset primary temperature threshold or the final warning threshold. If it exceeds the primary temperature threshold, the central control unit will control the refrigeration device 320 to start refrigeration or increase the power of the refrigeration device 320; if the temperature exceeds the final warning threshold, the central control unit will control the driving member 210 to stop running and stop the RF energy output.

[0110] Furthermore, as Figure 4 shown, the driving mechanism 200 includes a driving member 210, a transmission member 220 and a driving rod 230. The driving member 210 is drivingly connected to the driving rod 230 through the transmission member 220, and the cold conduction assembly 300 is connected to the driving rod 230. It can be understood that the driving member 210 drives the driving rod 230 to move through the transmission member 220, thereby driving the cold conduction assembly 300 to move, and the microneedle assembly 400 connected to the cold conduction assembly 300 also moves accordingly.

[0111] In this embodiment, a pressure sensor 231 is provided at the end of the driving rod 230 facing the heat conduction component 300, and the pressure sensor 231 is electrically connected to the central control unit. It can be understood that the speed at which the microneedle array penetrates the skin directly affects the pain sensation of the human body. Different people and different parts of the skin require different forces when penetrated. The central control unit can adjust the power of the driving member 210 by receiving the pressure feedback from the pressure sensor 231 to ensure that the microneedle array can quickly penetrate into the human tissue and improve the experience effect.

[0112] In this embodiment, the driving member 210 is a motor, and an encoder 211 is installed on the motor. It can be understood that the encoder 211 can feedback the accurate stroke of the motor, and then feedback the actual depth of insertion of the microneedle electrode 420 into the human tissue. The central control unit can obtain the correction value of the insertion depth through the PID algorithm based on the difference between the insertion depth value h1 set by the user and the feedback value h2 of the encoder 211, and feedback it to the motor to ensure the accuracy of the depth of insertion of the microneedle electrode 420 into the human tissue.

[0113] Optionally, a fitting sensor can also be provided on the end face of the housing 100 in contact with the skin to detect whether the radiofrequency microneedle therapeutic instrument is in contact with the skin during treatment, which is beneficial to guiding the user to operate the therapeutic instrument correctly and avoiding the situation of skin burns caused by the microneedle electrode 420 releasing RF energy on the skin surface, further improving the safety of the treatment process.

[0114] The above are only optional embodiments of the present invention, and do not limit the patent scope of the present invention. Any equivalent structural transformation made by using the content of the specification and drawings of the present invention under the inventive concept of the present invention, or direct / indirect application in other related technical fields, is included in the patent protection scope of the present invention.

Claims

1. A radio frequency micro - needle array control device, characterized in that, the radio frequency micro - needle array control device includes: a power supply; a micro - needle array, including a PCB board and a plurality of micro - needle electrodes disposed on the PCB board; a switch - switching circuit, an input end of the switch - switching circuit is connected to the power supply, and a first output end of the switch - switching circuit is electrically connected to the micro - needle array through the PCB board; a main controller, the working modes stored in the main controller include a bipolar mode. In the bipolar mode, the electrode polarities of at least one of the micro - needle electrodes in the micro - needle array are opposite to those of the remaining micro - needle electrodes. The main controller controls the switch - switching circuit to connect the power supply and the micro - needle array, and the main controller controls the switch - switching circuit to switch the electrode polarities of the micro - needle electrodes in the micro - needle array.

2. The radio frequency micro - needle array control device according to claim 1, characterized in that, in the bipolar mode, the micro - needle electrodes of the micro - needle array perform at least one power - terminal switching through switch control.

3. The radio frequency micro - needle array control device according to claim 1, characterized in that, the working modes stored in the main controller further include a unipolar mode. In the unipolar mode, the electrode polarities of a plurality of micro - needle electrodes in the micro - needle array are the same. The main controller controls the switch - switching circuit to connect the power supply, the micro - needle array and a return electrode; the main controller is used to control the switch - switching circuit to work so as to control the micro - needle array to switch between the unipolar mode and the bipolar mode.

4. The radio frequency micro - needle array control device according to claim 3, characterized in that, the main controller is used to control the switch - switching circuit to work so as to control the micro - needle array to switch between the unipolar mode and the bipolar mode at least once during a treatment process, or control the micro - needle array to switch between the unipolar mode and the bipolar mode at a preset period.

5. The radio frequency micro - needle array control device according to any one of claims 1 to 4, characterized in that, the power supply includes: a plurality of independent radio frequency power supplies, and the radio frequency power supplies are connected to the switch - switching circuit.

6. The radio frequency micro - needle array control device according to claim 5, characterized in that, it further includes an impedance detection circuit. The impedance detection circuit is connected to each of the micro - needle electrodes in the micro - needle array, an output end of the impedance detection circuit is connected to the main controller, and the main controller is further used to control the corresponding radio frequency power supply to adjust the output according to the feedback of the detected impedance so as to ensure uniform energy between treatment areas.

7. A radio frequency micro - needle array control method, applied to a radio frequency micro - needle array control device, where the radio frequency micro - needle array control device includes: a power supply; a micro - needle array, including a PCB board and a plurality of micro - needle electrodes disposed on the PCB board; a switch - switching circuit, an input end of the switch - switching circuit is connected to the power supply, and a first output end of the switch - switching circuit is electrically connected to the micro - needle array through the PCB board; characterized in that, The radio frequency micro-needle array control method includes: In bipolar mode, controlling the switch switching circuit to connect the power supply and the micro-needle array, and controlling the switch switching circuit to switch the electrode polarities of the micro-needle electrodes of the micro-needle array; wherein, in bipolar mode, the electrode polarities of at least one of the micro-needle electrodes in the micro-needle array are opposite to those of the remaining micro-needle electrodes.

8. The radio frequency micro-needle array control method according to claim 7, characterized in that the step of controlling the switch switching circuit to switch the electrode polarities of the micro-needle electrodes of the micro-needle array includes: After the micro-needle array has been continuously operating for a period of time, controlling the micro-needle electrodes of the micro-needle array to perform a power supply terminal switch through switch control.

9. The radio frequency micro-needle array control method according to claim 7, characterized in that the radio frequency micro-needle array control method further includes: acquiring the impedance value of the tissue between the positive and negative electrodes of the micro-needle electrode and a preset impedance threshold; controlling the radio frequency energy output of the power supply according to the acquired impedance value of the tissue between the positive and negative electrodes of the micro-needle electrode and the preset impedance threshold.

10. The radio frequency micro-needle array control method according to claim 9, characterized in that the step of controlling the radio frequency energy output of the power supply according to the acquired impedance value of the tissue between the positive and negative electrodes of the micro-needle electrode and the preset impedance threshold specifically includes: When the impedance value of the tissue between the positive and negative electrodes of the micro-needle continuously increases and is greater than the preset impedance threshold, controlling the power supply to reduce the radio frequency energy output.

11. A radio frequency micro-needle therapeutic apparatus, characterized in that it includes the radio frequency micro-needle array control device according to any one of claims 1 to 6, and further includes: a housing, with an opening at one end of the housing; a driving mechanism, installed in the housing; a heat conduction component, installed in the housing, and the heat conduction component is connected to the driving mechanism. The driving mechanism is used to drive the heat conduction component to move, so as to drive the micro-needle array to extend out of the housing or move back into the housing through the opening. The heat conduction component is used to refrigerate and cool the micro-needle array.

12. The radio frequency micro-needle therapeutic apparatus according to claim 11, characterized in that the driving mechanism includes a driving member, a transmission member and a driving rod. The driving member and the driving rod are drivingly connected through the transmission member. The heat conduction component is connected to the driving rod. A pressure sensor is provided at the end of the driving rod facing the heat conduction component, and is used to provide pressure feedback to adjust the power of the driving member.

13. The radio frequency micro-needle therapeutic apparatus according to claim 11, characterized in that the heat conduction component includes a heat dissipation device and a refrigeration device. The refrigeration device is a thermoelectric cooler, including a hot end and a cold end arranged in a stacked manner. An insulating layer is provided between the cold end and the PCB board, and a temperature sensor is provided in the insulating layer, and is used to detect the temperature of the micro-needle electrode.

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