Temperature-controlled radio frequency microneedle system

Abstract

This invention relates to a temperature-controlled radiofrequency microneedle system, comprising: a microneedle array including two or more microneedles; and a temperature sensor disposed on the tip or surface of at least one microneedle for sensing the temperature around the tip. This temperature-controlled radiofrequency microneedle system can precisely control the temperature in real time during use, ensuring the optimal temperature for radiofrequency microneedle treatment and avoiding adverse effects caused by excessively high or low temperatures.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a temperature-controlled radiofrequency microneedle system. Background Technology

[0002] Currently, medical aesthetic and dermatology treatment products are gaining increasing attention, such as moxibustion devices, acid-reducing devices, and vibration massagers, providing a wide range of choices for customers, especially women, seeking beauty. Radiofrequency microneedling medical aesthetic products work by applying radiofrequency to skin tissue, increasing local tissue temperature and promoting cell absorption of medication. However, different skin types, and even the same skin type during different treatments, exhibit highly sensitive skin tissue to temperature changes. Temperatures that are too high or too low are detrimental to cell absorption of the solution, affecting treatment efficacy. Therefore, strict control of the temperature caused by radiofrequency microneedling is necessary. However, currently, there is no ideal method to achieve precise temperature monitoring and control in the aforementioned process. Summary of the Invention

[0003] The objective of this invention is to provide a temperature-controlled radiofrequency microneedle system that can precisely control the temperature in real time during use, ensuring the optimal temperature for radiofrequency microneedle treatment and avoiding adverse effects caused by excessively high or low temperatures.

[0004] To address the problems existing in the prior art, this invention provides a temperature-controlled radio frequency microneedle system, comprising:

[0005] Microneedle array, which contains two or more microneedles;

[0006] A temperature sensor, which is disposed on the tip or body surface of at least one microneedle, is used to sense the temperature around the tip.

[0007] The present invention also provides a temperature-controlled radio frequency microneedle system, characterized in that it comprises:

[0008] A microneedle array comprising two or more microneedles, at least one of which is a hollow microneedle;

[0009] A temperature sensor is disposed on a microfilament inserted into the middle portion of the hollow microneedle to sense the temperature around the microneedle.

[0010] In one embodiment of the present invention, the temperature-controlled radio frequency microneedle system further includes:

[0011] An integrated circuit module is connected to a microneedle array and a temperature sensor and is configured to provide radio frequency energy to the microneedle array, power the temperature sensor and receive the temperature signal from the temperature sensor, and adjust the power of the radio frequency energy based on the temperature signal.

[0012] In one embodiment of the present invention, the temperature sensor includes:

[0013] The sensitive unit is a double-helix coil, wherein the two lines of the double-helix coil do not cross each other and are connected to each other at the top.

[0014] An insulating protective layer covering the sensitive unit;

[0015] Lead electrodes, the lead electrodes being connected to the integrated circuit module; and

[0016] A lead wire connects the sensitive unit and the lead electrode.

[0017] In one embodiment of the present invention, the double-helix coil is a thin-film sensitive material with a thickness of 1 nanometer to 1 millimeter, a linewidth of 5 micrometers to 500 micrometers, a spacing of 5 micrometers to 800 micrometers, and 5 to 20 turns; and / or

[0018] The lead wire has a linewidth of 20-200 micrometers and a length of 2-50 millimeters; and / or

[0019] The lead electrode is 0.4 mm to 5 mm long and 0.3 mm to 5 mm wide.

[0020] In one embodiment of the present invention, the sensitive unit is prepared using micro-nano fabrication technology. Photoresist is coated on the surface of microneedles or microfilaments, and then the photoresist is exposed using photolithography to form a predetermined spiral pattern. Next, a sensitive material is deposited to form the sensitive unit. Finally, the photoresist is removed using a stripping process, and an insulating protective layer is applied.

[0021] In one embodiment of the present invention, the microneedle array is arranged on a first side of the carrier plate, and the integrated circuit module is arranged on a second side of the carrier plate;

[0022] The integrated circuit module includes:

[0023] The radio frequency (RF) transmitter module is configured to generate RF signals to provide RF power to the microneedle array;

[0024] A temperature control module is configured to collect the temperature signal detected by the temperature sensor and determine whether the temperature is the specified heating treatment temperature;

[0025] A radio frequency energy regulation module is configured to control the power of the radio frequency transmitting module to regulate the radio frequency energy output of the radio frequency transmitting module.

[0026] In one embodiment of the present invention, the microneedle array is inserted into the subcutaneous tissue, the radio frequency transmitting module generates a radio frequency signal to provide radio frequency energy to the microneedle array, and the microneedle array introduces the radio frequency energy into the subcutaneous tissue for heating.

[0027] The temperature sensor detects the temperature of the microneedles and subcutaneous tissue, and transmits the temperature signal to the temperature control module in real time;

[0028] The temperature control module determines whether the temperature value measured by the temperature sensor is the specified temperature. If the temperature is higher or lower than the specified temperature, it transmits a signal to the radio frequency energy adjustment module. The radio frequency energy adjustment module controls and adjusts the power of the radio frequency transmitting module to adjust the output of radio frequency energy.

[0029] In one embodiment of the present invention, the microneedle has a diameter of 0.1 mm to 2 mm and a length of 2 mm to 50 mm.

[0030] In one embodiment of the present invention, the temperature sensor is fabricated directly on the surface of microfilaments or microneedles using inkjet printing technology.

[0031] In one embodiment of the invention, the microneedles containing temperature sensors comprise 0.5%-10% of the total number of microneedles.

[0032] The present invention has at least the following beneficial effects: The temperature-controlled radiofrequency microneedle system disclosed in this invention has a high-precision real-time temperature monitoring function, and can adjust the temperature in real time through a feedback control unit. It can accurately control the temperature in real time during use, ensuring the optimal temperature for radiofrequency microneedle treatment, improving the treatment effect of radiofrequency microneedles, and avoiding the adverse effects caused by excessively high or low temperatures. The temperature sensor is integrated in situ onto the surface of the radiofrequency microneedle, which not only reduces the size of the entire temperature-controlled radiofrequency microneedle system, but also improves the accuracy of temperature monitoring, making temperature control more precise and effective. It can continuously adjust the temperature of the microneedle in real time, so that the working effect of the microneedle reaches the optimal level. Attached Figure Description

[0033] To further illustrate the above and other advantages and features of the various embodiments of the present invention, a more specific description of the embodiments of the invention will be presented with reference to the accompanying drawings. It is to be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit its scope. In the drawings, identical or corresponding parts will be indicated by identical or similar reference numerals for clarity.

[0034] Figure 1 A schematic diagram of a radio frequency microneedle system according to an embodiment of the present invention is shown;

[0035] Figure 2 A schematic diagram of a temperature sensor integrated at the tip of a microneedle according to an embodiment of the present invention is shown;

[0036] Figure 3 A schematic diagram of a temperature sensor integrated into a microneedle body according to an embodiment of the present invention is shown;

[0037] Figure 4 A schematic diagram of a double-helix coil structure of a temperature sensor sensing unit according to an embodiment of the present invention is shown;

[0038] Figure 5 A schematic diagram of the lead wire and lead electrode structure of a microneedle surface temperature sensor according to an embodiment of the present invention is shown;

[0039] Figure 6 A scanning electron microscope image of a temperature sensor sensing unit integrated onto the surface of a microneedle body, according to an embodiment of the present invention, is shown; and

[0040] Figure 7 A schematic diagram of the workflow of the radio frequency microneedle system according to an embodiment of the present invention is shown. Detailed Implementation

[0041] It should be noted that the components in the accompanying drawings may be shown exaggerated for illustrative purposes and may not be to scale.

[0042] In this invention, the various embodiments are merely intended to illustrate the solutions of the invention and should not be construed as limiting.

[0043] In this invention, unless otherwise specified, the quantifiers “a” and “one” do not exclude scenarios involving multiple elements.

[0044] It should also be noted that, in the embodiments of the present invention, only a portion of the parts or components may be shown for clarity and simplicity. However, those skilled in the art will understand that, under the teachings of the present invention, the required parts or components can be added as needed for specific scenarios.

[0045] It should also be noted that within the scope of this invention, the terms "same", "equal", and "equal to" do not mean that the two values ​​are absolutely equal, but allow for a certain reasonable error. In other words, the terms also cover "substantially the same", "substantially equal", and "substantially equal to".

[0046] It should also be noted that in the description of this invention, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not explicitly or implicitly suggest that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0047] Furthermore, the embodiments of the present invention describe the process steps in a specific order. However, this is only for the convenience of distinguishing each step, and is not a limitation on the order of each step. In different embodiments of the present invention, the order of each step can be adjusted according to the process.

[0048] Figure 1 A schematic diagram of a radio frequency microneedle system according to an embodiment of the present invention is shown.

[0049] like Figure 1 As shown, a radio frequency microneedle system includes a microneedle array, a temperature sensor, a carrier plate 100, and an integrated circuit module. The carrier plate 100 can mount the microneedle array and the integrated circuit module. The microneedle array is arranged on a first side of the carrier plate, and the integrated circuit module is arranged on a second side of the carrier plate, opposite to the microneedle array. In other embodiments of the invention, the integrated circuit module may also exist independently, but be connected to the microneedle array via wires or other means.

[0050] In embodiments of the present invention, the dimensions of the carrier plate 100 can be set as follows: length 5 mm-15 mm, width 5 mm-15 mm, and thickness 0.5 mm-2 mm. Materials include, but are not limited to, wood, stainless steel, copper alloy, and polymer materials. In other embodiments of the present invention, the carrier plate 100 can be set to other shapes, such as circular, elliptical, or other arbitrary shapes.

[0051] The microneedle array comprises multiple microneedles 101 arranged in an array. In embodiments of the present invention, the diameter of the microneedles 101 can range from 0.1 mm to 2 mm. The length of the microneedles 101 ranges from 2 mm to 50 mm. The material of the microneedles 101 can be any conductive metal or other conductive material, such as stainless steel, gold, silver, platinum, platinum-iridium alloy, tungsten, or a robust conductive polymer material, or the material of the microneedles 101 can be a non-conductive material with a layer of the aforementioned conductive material on its surface. Multiple microneedles can be arranged in a matrix, for example, a 10×10 matrix. The arrangement of the microneedle array includes, but is not limited to, rectangular, circular, and triangular arrangements. The total number of microneedles 101 can range from 25 to 500.

[0052] Those skilled in the art should understand that the material, size, quantity, and other parameters of microneedles are not limited to the specific examples mentioned above, and they can select the material, size, and quantity of microneedles according to actual needs.

[0053] Those skilled in the art should understand that the material, size, and other parameters of the carrier plate are not limited to the specific examples mentioned above, and they can select the material and size of the carrier plate according to actual needs.

[0054] Figure 2A schematic diagram of a temperature sensor integrated at the tip of a microneedle according to an embodiment of the present invention is shown; Figure 3 A schematic diagram of a temperature sensor integrated into a microneedle body according to an embodiment of the present invention is shown; Figure 4 A schematic diagram of a double-helix coil structure of a temperature sensor sensing unit according to an embodiment of the present invention is shown; and Figure 5 A schematic diagram of the lead wire and lead electrode structure of a microneedle surface temperature sensor according to an embodiment of the present invention is shown; Figure 6 A scanning electron microscope image of a temperature sensor sensing unit integrated on the surface of a microneedle body according to an embodiment of the present invention is shown.

[0055] like Figures 2 to 6 As shown, a temperature sensor 102 is positioned at the tip or body of a microneedle 101, and a lead electrode 103 is located at the end furthest from the tip. The temperature sensor 102 and the lead electrode 103 are connected via a lead 104. The temperature sensor 102 includes a sensitive element and an insulating protective layer covering the sensitive element. The lead electrode 103 can be connected to an integrated circuit module via the lead. The integrated circuit module powers the temperature sensor 102 and acquires temperature signals for analysis.

[0056] The sensing element 105 of the temperature sensor 102 is a double helix coil. The two wires of the double helix coil do not cross each other, are connected to each other at the top, and are connected to a lead wire 104 at the bottom, which is connected to the lead electrode 103 located at the other end of the microneedle 101.

[0057] In embodiments of the present invention, the double-helix coil is made of a thin-film sensitive material with a thickness ranging from 1 nanometer to 1 millimeter, a linewidth ranging from 5 micrometers to 500 micrometers, a spacing ranging from 5 micrometers to 800 micrometers, and a number of coil turns ranging from 5 to 20. The lead wire 104 has a linewidth ranging from 20 micrometers to 200 micrometers and a length ranging from 2 millimeters to 50 millimeters. The lead electrode 103 has a length ranging from 0.4 millimeters to 5 millimeters and a width ranging from 0.3 millimeters to 5 millimeters.

[0058] It is worth noting that one or more microneedles equipped with temperature sensors (hereinafter referred to as sensing microneedles) together with the other microneedles form a microneedle array. The number of sensing microneedles varies from 0.5% to 10% of the total number of microneedles, and there must be at least one. The position of the sensing microneedles is not limited and can be placed at the edge, center, or any other location of the microneedle array.

[0059] The insulating protective layer can be made of organic materials such as Parylene-C or PI to isolate the sensitive unit from the external environment and prevent corrosion or short circuits. The thickness of the insulating protective layer can range from 10 nanometers to 5 micrometers. However, those skilled in the art should understand that the material and thickness of the insulating protective layer are not limited to the examples above, and they can choose the material and thickness of the insulating protective layer according to actual needs.

[0060] Those skilled in the art should understand that the materials, dimensions, and spacing of the double-helix coil are not limited to the specific examples described above, and they can select the materials and dimensions of the double-helix coil according to actual needs. Similarly, those skilled in the art should understand that the dimensions of the leads and lead electrodes are not limited to the specific examples described above, and they can select the dimensions of the leads and lead electrodes according to actual needs. Commercially available conductors, enameled wire, or copper wire can be used as leads.

[0061] In other embodiments of the present invention, a hollow microneedle can be used to mount a temperature sensor. The temperature sensor can be disposed on the surface of the microneedle or fabricated independently and inserted into the hollow of the microneedle, thereby forming a sensing microneedle. The size, number, and arrangement of the microneedles are the same as in the embodiments described above. Those skilled in the art should understand that using similar sensing microneedles as a method of monitoring the operating temperature of the microneedle array is within the scope of protection of the present invention.

[0062] Temperature sensors on microneedles are fabricated directly on the surface of the microneedles using micro / nano fabrication processes or inkjet printing. If the microneedles are made of conductive materials, an insulating material must be deposited on the surface of the microneedles before fabricating the temperature sensor to isolate it from the microneedles. For example, when in-situ integrating the sensitive unit of a temperature sensor using micro / nano fabrication processes, photoresist is first coated on the surface of the microneedles. Then, photolithography is used to expose the photoresist, forming a predetermined spiral or other folded pattern. Next, a sensitive material, such as metals like Pt or Au, or combinations like Cr / Pt, Cr / Au, Ti / Pt, or Ti / Au, is deposited as the sensitive material for the temperature sensor. Finally, a lift-off process is used to remove the photoresist, and an insulating protective layer is applied. The above is the main method for integrating temperature sensors onto the surface of microneedles, but it is not limited to this method. Temperature sensors can also be fabricated on the surface of finer microfilaments using similar methods and then inserted into the interior of hollow microneedles, where the cross-section of the microfilament is smaller than the hollow cross-section of the hollow microneedle.

[0063] Temperature sensors operate on the principle of thermal resistance. The sensing element is a metal or other temperature-sensitive material. When the temperature changes, the resistance of the metal or other sensitive material changes. By measuring this change in resistance, the current temperature can be estimated. Each metal or temperature-sensitive material has its own thermoresistivity coefficient, and the temperature can be calculated based on this coefficient and the measured resistance change.

[0064] Figure 7 A schematic diagram of the workflow of the radio frequency microneedle system according to an embodiment of the present invention is shown.

[0065] The integrated circuit module's functions include, but are not limited to, providing partial radio frequency (RF) power to the microneedle array, wireless signal transmission, real-time collection and processing of temperature information acquired by the temperature sensor, and real-time adjustment of RF energy for temperature control. The integrated circuit module includes a temperature control module and an RF energy regulation module. The temperature control module collects the temperature signal detected by the temperature sensor and determines that the temperature is suitable for heating and treatment. The RF energy regulation module adjusts the RF energy output of the RF transmitting module by controlling the power.

[0066] The integrated circuit module also includes an RF transmitter module, which generates a power-controlled RF signal. The RF transmitter module is mounted on a carrier board and connected to a microneedle array.

[0067] like Figure 6 As shown, the workflow of this temperature-controlled microneedle system is as follows: During use, the microneedle array is inserted into the subcutaneous tissue, and the integrated circuit module powers the temperature sensor. The radio frequency (RF) transmitter module generates an RF signal, providing RF energy to the microneedle array. The microneedle array then delivers this RF energy into the subcutaneous tissue for microneedle heating therapy. Under the influence of the RF signal, the temperature begins to rise. The temperature sensor integrated on the microneedle monitors the temperature of the microneedle surface and the surrounding subcutaneous tissue in situ, transmitting the temperature signal to the temperature control module in real time. The temperature control module determines whether the temperature value measured by the temperature sensor is within the specified heating therapy temperature. If the temperature value is higher than the specified heating therapy temperature, a signal is transmitted to the RF energy adjustment module, which reduces the power of the RF transmitter module to decrease the RF energy output, thus lowering the temperature. If the temperature value is lower than the specified heating therapy temperature, a signal is transmitted to the RF energy adjustment module, which increases the power of the RF transmitter module to increase the RF energy output, thus raising the temperature. If the temperature is suitable, the RF energy remains constant. Through the control and adjustment of the above system, the temperature of the microneedles can be maintained at the optimal set temperature, maximizing the effectiveness of aesthetic or skin treatments.

[0068] The present invention has at least the following beneficial effects: The temperature-controlled radiofrequency microneedle system disclosed in this invention has a high-precision real-time temperature monitoring function, and can adjust the temperature in real time through a feedback control unit. It can accurately control the temperature in real time during use, ensuring the optimal temperature for radiofrequency microneedle treatment, improving the treatment effect of radiofrequency microneedles, and avoiding the adverse effects caused by excessively high or low temperatures. The temperature sensor is integrated in situ onto the surface of the radiofrequency microneedle, which not only reduces the size of the entire temperature-controlled radiofrequency microneedle system, but also improves the accuracy of temperature monitoring, making temperature control more precise and effective. It can continuously adjust the temperature of the microneedle in real time, so that the working effect of the microneedle reaches the optimal level.

[0069] While some embodiments of the present invention have been described in this application, those skilled in the art will understand that these embodiments are merely illustrative. Numerous variations, alternatives, and improvements will arise in those skilled in the art under the teachings of this invention without departing from its scope. The appended claims are intended to define the scope of the invention and thereby cover methods and structures within the scope of the claims themselves and their equivalents.

Claims

1. A temperature-controlled radio frequency microneedle system, characterized by, include: Microneedle array, which contains two or more microneedles; A temperature sensor is disposed on the tip or body surface of at least one microneedle for sensing the temperature around the tip. The temperature sensor includes: a sensitive unit, which is a double-helix coil with two non-crossing lines connected at the top; an insulating protective layer covering the sensitive unit; the sensitive unit is fabricated using micro / nano fabrication processes, including coating the microneedle surface with photoresist, exposing the photoresist using photolithography to form a predetermined helical pattern, depositing a sensitive material to form the sensitive unit, removing the photoresist using a lift-off process, and applying an insulating protective layer; the double-helix coil is a thin-film sensitive material with a thickness of 1 nanometer to 1 millimeter, a linewidth of 5 micrometers to 500 micrometers, a spacing of 5 micrometers to 800 micrometers, and 5 to 20 turns. An integrated circuit module, connected to a microneedle array and a temperature sensor and configured to provide radio frequency energy to the microneedle array, power the temperature sensor and receive temperature signals from the temperature sensor, and adjust the power of the radio frequency energy based on the temperature signals; the integrated circuit module includes: a radio frequency transmitting module configured to generate radio frequency signals to provide radio frequency energy to the microneedle array; a temperature control module configured to collect the temperature signals detected by the temperature sensor and determine whether the temperature is a specified heating treatment temperature; and a radio frequency energy adjustment module configured to control the power of the radio frequency transmitting module to adjust the radio frequency energy output of the radio frequency transmitting module.

2. A temperature-controlled radio frequency microneedle system, characterized by, include: A microneedle array comprising two or more microneedles, at least one of which is a hollow microneedle; A temperature sensor is disposed on a microfilament inserted into the middle portion of a hollow microneedle to sense the temperature surrounding the microneedle. The temperature sensor includes: a sensitive unit, which is a double-helix coil with two non-crossing lines connected at their tips; an insulating protective layer covering the sensitive unit; the sensitive unit is fabricated using micro-nano fabrication processes, including coating the microfilament surface with photoresist, exposing the photoresist using photolithography to form a predetermined helical pattern, depositing a sensitive material to form the sensitive unit, removing the photoresist using a lift-off process, and applying an insulating protective layer; the double-helix coil is a thin-film sensitive material with a thickness of 1 nanometer to 1 millimeter, a linewidth of 5 micrometers to 500 micrometers, a spacing of 5 micrometers to 800 micrometers, and 5 to 20 turns. An integrated circuit module, connected to a microneedle array and a temperature sensor and configured to provide radio frequency energy to the microneedle array, power the temperature sensor and receive temperature signals from the temperature sensor, and adjust the power of the radio frequency energy based on the temperature signals; the integrated circuit module includes: a radio frequency transmitting module configured to generate radio frequency signals to provide radio frequency energy to the microneedle array; a temperature control module configured to collect the temperature signals detected by the temperature sensor and determine whether the temperature is a specified heating treatment temperature; and a radio frequency energy adjustment module configured to control the power of the radio frequency transmitting module to adjust the radio frequency energy output of the radio frequency transmitting module.

3. The temperature-controlled radio frequency microneedle system of claim 1 or 2, wherein, The temperature sensor also includes: Lead electrodes, the lead electrodes being connected to the integrated circuit module; and A lead wire connects the sensitive unit and the lead electrode.

4. The temperature-controlled radio frequency microneedle system according to claim 3, characterized in that, The lead wire has a linewidth of 20-200 micrometers and a length of 2-50 millimeters; and / or The lead electrode is 0.4 mm to 5 mm long and 0.3 mm to 5 mm wide.

5. The temperature-controlled radio frequency microneedle system according to claim 1 or 2, characterized in that, The microneedle array is arranged on the first side of the carrier plate, and the integrated circuit module is arranged on the second side of the carrier plate.

6. The temperature-controlled radio frequency microneedle system according to claim 5, characterized in that, The microneedle array is inserted into the subcutaneous tissue, and the radio frequency transmitting module generates a radio frequency signal to provide radio frequency energy to the microneedle array. The microneedle array then introduces the radio frequency energy into the subcutaneous tissue for heating treatment. The temperature sensor detects the temperature of the microneedles and subcutaneous tissue, and transmits the temperature signal to the temperature control module in real time; The temperature control module determines whether the temperature value measured by the temperature sensor is the specified temperature. If the temperature is higher or lower than the specified temperature, it transmits a signal to the radio frequency energy adjustment module. The radio frequency energy adjustment module controls and adjusts the power of the radio frequency transmitting module to adjust the output of radio frequency energy.

7. The temperature-controlled radio frequency microneedle system according to claim 1 or 2, characterized in that, The microneedles have a diameter of 0.1 mm to 2 mm and a length of 2 mm to 50 mm.

8. The temperature-controlled radio frequency microneedle system according to claim 1 or 2, characterized in that, The temperature sensor is fabricated directly onto the surface of microfilaments or microneedles using inkjet printing technology.

9. The temperature-controlled radio frequency microneedle system according to claim 1 or 2, characterized in that, Microneedles containing temperature sensors account for 0.5% to 10% of the total number of microneedles.

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