Electrode assembly, treatment tool, electrotherapy device, and control method thereof

Abstract

This invention discloses an electrode assembly, a treatment handpiece, an electrotherapy device, and a control method, relating to the field of medical device technology. The electrode assembly, used in the electrotherapy device, includes a base, a flexible film, and a flexible electrode. The base is made of a rigid material, and the edge of the flexible film is sealed to one end face of the base to form an inflation cavity. The inflation cavity communicates with an external inflation element, allowing it to have both a deflated state and an expanded state with gas filling. The flexible electrode is connected to one surface of the flexible film. The electrode assembly provided by this invention can better conform to the surface to be treated, enabling treatment of uneven surfaces.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrode assembly, a treatment handpiece, an electrotherapy device, and a control method thereof. Background Technology

[0002] Currently, the electrodes of non-invasive electrotherapy devices are generally rigid electrodes or can only undergo slight deformation. When using them, the electrodes need to be in contact with the surface to be treated. Since the electrodes are made of rigid materials and have a fixed shape, if the surface to be treated is uneven, such as the cheekbone area, the contact between the surface to be treated and the rigid electrode will be point contact. The energy density at the contact point will increase, which can lead to burns. Summary of the Invention

[0003] The main objective of this invention is to provide an electrode assembly, a treatment handpiece, an electrotherapy device, and a control method thereof, which aims to enable the electrode assembly to better fit the surface to be treated, thereby achieving treatment of uneven surfaces.

[0004] To achieve the above objectives, the present invention proposes an electrode assembly for use in an electrotherapy device. The electrode assembly includes a base, a flexible film, and a flexible electrode. The base is made of a rigid material, and the edge of the flexible film is sealed to one end face of the base to form an inflation cavity. The inflation cavity is connected to an external inflation element to have a deflated state and an expanded state with gas filling. The flexible electrode is connected to one surface of the flexible film.

[0005] In one embodiment, the flexible film is made of one of the following materials: polyimide, polyethylene terephthalate, or polydimethylsiloxane.

[0006] In one embodiment, the flexible electrode is made of one or more of the following materials: polyaniline, polyacetylene, polypyrrole, polythiophene, and graphene nanocomposite.

[0007] In one embodiment, a groove is provided on one end face of the base, a locking ring is provided at the opening of the groove, the edge of the flexible film is connected to the bottom wall of the groove, a sealing element is also provided in the groove, the sealing element is arranged around the periphery of the flexible film, and the locking ring presses the sealing element and the edge of the flexible film against the bottom of the groove.

[0008] In one embodiment, the flexible electrode is disposed within the air-filled cavity and connected to a surface of the flexible film facing the base.

[0009] In one embodiment, the flexible electrode includes a plurality of sub-flexible electrode sheets spaced apart from the flexible film; or, the flexible electrode is a single, complete electrode that extends along the length of the flexible film.

[0010] In one embodiment, the electrode assembly further includes a gas pressure sensor and a contact pressure sensor. The gas pressure sensor is disposed on the flexible film and is used to detect the gas pressure in the inflation chamber. The contact pressure sensor is disposed on the flexible film and is used to detect the contact pressure between the flexible film and the surface to be treated.

[0011] And / or, the electrode assembly further includes a temperature sensor disposed on the surface of the flexible electrode facing the base, and used to detect the temperature of the flexible electrode.

[0012] In one embodiment, the gas introduced into the inflation chamber by the inflation element is a cooling gas, which is used to reduce the temperature of the flexible electrode.

[0013] The present invention also proposes a therapeutic hand device, including a handle and an electrode assembly as described above, wherein the electrode assembly is disposed on the handle and electrically connected to the circuit board of the handle.

[0014] The present invention also proposes an electrotherapy device, including a main unit and a treatment hand as described above. The main unit includes an electronic control element and an inflation element. The electronic control element is electrically connected to the flexible electrode and the inflation element, respectively. The inflation element is in communication with the inflation chamber.

[0015] The present invention also proposes a control method for use in the electrotherapy device described above, wherein the electrotherapy device is used to treat a target surface, and the control method includes the following steps:

[0016] The inflation element is controlled to inflate the inflation chamber with gas, so that the inflation chamber is in the inflated state.

[0017] The flexible film is controlled to abut against the target surface, and the flexible film and the flexible electrode deform to conform to the target surface;

[0018] Control the output of electrical energy from the flexible electrode.

[0019] In one embodiment, the electrotherapy device further includes a gas pressure sensor disposed in the inflation chamber, a contact pressure sensor disposed in the flexible film, and a temperature sensor. After the step of controlling the output of electrical energy from the flexible electrode, the device further includes:

[0020] Obtain the air pressure value inside the inflation chamber;

[0021] Obtain the contact pressure value between the flexible film and the target surface;

[0022] If the air pressure value is lower than the first air pressure threshold, the inflation element is controlled to fill the inflation chamber with gas until the air pressure value is higher than the first air pressure threshold.

[0023] If the air pressure value is higher than the second air pressure threshold, the inflation element is controlled to extract the gas from the inflation chamber until the air pressure value is lower than the second air pressure threshold.

[0024] If the contact pressure value is lower than the contact pressure threshold, the inflation element is controlled to fill the inflation chamber with gas until the gas pressure value is higher than the contact pressure threshold.

[0025] In one embodiment, after the step of controlling the output electrical energy of the flexible electrode, the method further includes:

[0026] Obtain the temperature of the flexible electrode;

[0027] If the temperature is higher than the temperature threshold, the inflation element is controlled to fill the inflation chamber with the cooled gas until the temperature is lower than the temperature threshold.

[0028] The technical solution of this invention employs a flexible electrode attached to a flexible film, which is then sealed and connected to a base, forming an inflatable cavity with the base surface. Before treatment, a certain amount of gas is injected into the inflatable cavity, causing the flexible film and flexible electrode to be in a state of inflation. During treatment, external force is used to adhere the flexible film and flexible electrode to the surface of the area to be treated. Due to the gas filling the inflatable cavity, the flexible film and flexible electrode can deform according to the curvature of the area to be treated, and adhere tightly to the surface of the area to be treated, thus achieving treatment of uneven surfaces and improving the treatment effect. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0030] Figure 1 A schematic diagram of the structure of an embodiment of the electrode assembly provided by the present invention;

[0031] Figure 2 This is a schematic diagram of the structure of an embodiment of the electrotherapy device provided by the present invention;

[0032] Figure 3 This is a flowchart illustrating an embodiment of the control method provided by the present invention.

[0033] Explanation of icon numbers:

[0034] 100. Electrotherapy device; 10. Electrode assembly; 11. Base; 12. Flexible film; 13. Flexible electrode; 14. Inflation chamber; 15. Gas pressure sensor; 16. Temperature sensor; 20. Main unit; 21. Inflation element.

[0035] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0036] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0037] It should be noted that if the embodiments of the present invention involve directional indications (such as up, down, left, right, front, back, etc.), the directional indications are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0038] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the use of "and / or" or "and / or" throughout the text includes three parallel solutions. For example, "A and / or B" includes solution A, solution B, or a solution where both A and B are satisfied simultaneously. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0039] Currently, the electrodes of non-invasive electrotherapy devices are generally rigid electrodes or can only undergo slight deformation. When using them, the electrodes need to be in contact with the surface to be treated. Since the electrodes are made of rigid materials and have a fixed shape, if the surface to be treated is not flat, the contact between the surface to be treated and the rigid electrode will be point contact. The energy density at the contact point will increase, which can lead to burns.

[0040] This invention proposes an electrode assembly, an electrotherapy device, and a control method thereof, which aims to enable the electrode assembly to better fit the surface to be treated, thereby achieving treatment of uneven surfaces, and is particularly suitable for treating non-cavity external skin surfaces.

[0041] Please see Figure 1 and Figure 2 In one embodiment of the present invention, the electrode assembly 10 includes a base 11, a flexible film 12 and a flexible electrode 13. The base 11 is made of a rigid material. The edge of the flexible film 12 is sealed to one end face of the base 11 to form an inflation cavity 14. The inflation cavity 14 is connected to an external inflation element 21 to have a deflated state and an expanded state with gas filling. The flexible electrode 13 is connected to one surface of the flexible film 12.

[0042] In this embodiment, the electrode assembly 10 is used to electrically connect with the energy generating component of the electrotherapy device 100, and to perform electrical energy therapy on the treatment area through the electrode assembly 10. The electrode assembly 10 includes a base 11, a flexible film 12, and a flexible electrode 13. The base 11 is mainly used to support the flexible film 12 and connect to components such as the handle or main unit 20 of the electrotherapy device 100. The base 11 and the flexible electrode 13 are arranged opposite to each other so that when the base 11 is pressed towards the skin, the flexible electrode 13 can press against the skin. The shape of the base 11 can be plate-shaped, cylindrical, or cuboid, etc. The base 11 is made of a lightweight, high-strength, rigid material to ensure the stability and durability of the overall structure, such as hard plastic or lightweight aluminum alloy. The specific shape and material of the base 11 can be determined according to the usage scenario and treatment environment, and are not further limited here. The flexible electrode 13 is made of conductive polymer or nanocomposite materials, such as polyaniline, polyacetylene, or polypyrrole. These materials have good conductivity and flexibility, ensuring that they are not easily broken under external force while maintaining stable electrical performance. The surface of the flexible electrode 13 can be patterned according to application requirements, such as forming specific conductive paths through laser etching or chemical etching, to adapt to different treatment device designs. The flexible electrode 13 can be a capacitive electrode, located inside the flexible film 12, i.e., not in direct contact with the skin, indirectly delivering electrical energy to the treatment site through the flexible film 12. This avoids the high energy density at the contact point caused by poor local contact of contact electrodes (such as poor local contact caused by uncleaned small particles or acne protrusions on the tissue surface). Alternatively, the flexible electrode 13 can also be located on the outside of the flexible film 12, directly contacting the skin to deliver electrical energy to the treatment site.

[0043] For electrotherapy devices targeting cavities, there is a structural design that utilizes a rigid electrode in conjunction with a flexible shell in a rod-shaped treatment head. This design is primarily based on the fact that cavities themselves are relatively soft tissues without supporting structures such as bones. The cylindrical inner wall structure of the cavity creates spatial constraints on the radial expansion of the flexible shell, thereby achieving good contact between the soft cavity wall and the rigid electrode. Essentially, this is because the cavity is a radially enclosed space. However, for external skin, there is no such enclosed space. Instead, rigid tissues such as bones beneath the skin create a linear constraint on the electrode assembly. In this case, on the one hand, the inflatable electrode structure cannot achieve perfect contact between the two by relying on its own structural constraints with the tissue itself; external force is required. On the other hand, the rigid tissues such as bones beneath the skin pose an obstacle to perfect contact between the electrode and the skin. Therefore, this application avoids the contact obstacles between two rigid objects by setting the electrode as a flexible electrode, and can achieve good contact between the electrode and the skin by utilizing the deformation of the electrode.

[0044] The flexible film 12 is made of a polymer film material with high elastic modulus and good adhesion, such as polyimide or polyethylene terephthalate. These materials can effectively support the flexible electrode 13 and are not damaged during repeated bending and stretching, extending the service life of the electrode assembly 10. The connection between the base 11 and the flexible film 12 can be achieved by adhesive bonding, mechanical sealing with a sealing ring, or a combination of both. This securely and airtightly fixes the flexible film 12, preventing displacement or detachment during use that could cause leakage in the inflation chamber 14 and affect the normal use of the treatment head. The connection between the flexible electrode 13 and the flexible film 12 is achieved by adhesive bonding, such as thermoforming, chemical bonding, or ultrasonic welding, ensuring a tight connection between the flexible electrode 13 and the flexible film 12 and preventing performance degradation or malfunction due to interface separation during use. The gas introduced into the inflation chamber 14 can be an inert gas, such as nitrogen, which is relatively stable, or it can be air directly introduced. No further restrictions are made here.

[0045] In a preferred embodiment, a cooler gas or refrigerant at a lower temperature can be introduced and vaporized. When the refrigerant is sprayed out through a spray device, it evaporates rapidly. During the evaporation process, the refrigerant changes from a liquid to a gas, absorbing a large amount of heat. Refrigerant materials include, for example, tetrafluoroethane and chloroethane. Both of these can achieve a cooling effect, helping to lower the temperature of the flexible electrode 13 and preventing overheating and burns. In this embodiment, the gas serves both as an inlet and a coolant.

[0046] The technical solution of this invention employs a flexible electrode 13 attached to a flexible film 12, which is then sealed and connected to a base 11, forming an inflation cavity 14 with the surface of the base 11. Before treatment, a certain amount of gas is injected into the inflation cavity 14, causing the flexible film 12 and the flexible electrode 13 to be in a state of inflation and expansion. During treatment, external force is used to adhere the flexible film 12 and the flexible electrode 13 to the surface of the area to be treated. Because a certain amount of gas is injected into the inflation cavity 14, the flexible film 12 and the flexible electrode 13 can deform to a certain extent according to the curvature of the area to be treated, and fit tightly against the surface of the area to be treated, thereby achieving treatment of uneven surfaces and improving the treatment effect.

[0047] In one embodiment of the present invention, the flexible film 12 is made of one of the following materials: polyimide, polyethylene terephthalate, or polydimethylsiloxane.

[0048] In this embodiment, the flexible film 12 is made of one of the following materials: polyimide, polyethylene terephthalate, or polydimethylsiloxane. It has advantages such as high elastic modulus and good adhesion, which can bond well with the flexible electrode 13, effectively support the flexible electrode 13, and protect the electrode from damage during repeated inflation and stretching, thus extending the service life of the electrode assembly 10.

[0049] In one embodiment of the present invention, the flexible electrode 13 is made of one or more of the following materials: polyaniline, polyacetylene, polypyrrole, polythiophene, and graphene nanocomposite.

[0050] In this embodiment, the flexible electrode 13 is made of one or more of the following materials: polyaniline, polyacetylene, polypyrrole, polythiophene, or graphene nanocomposite materials. It possesses good conductivity and flexibility, ensuring that the flexible electrode 13 is not easily broken under external force and maintains good and stable electrical connection performance. The size of the flexible electrode 13 should be slightly smaller than the size of the flexible film 12. The flexible film 12 surrounding the flexible electrode 13 completely covers the surface of the tissue, ensuring that the flexible electrode 13 completely covers the tissue surface.

[0051] In one embodiment of the present invention, a groove is provided on one end face of the base 11, a locking ring is provided at the groove opening, the edge of the flexible film 12 is connected to the bottom wall of the groove, a sealing element is also provided in the groove, the sealing element is arranged around the periphery of the flexible film 12, and the locking ring presses the sealing element and the edge of the flexible film 12 against the bottom of the groove.

[0052] In this embodiment, the connection between the base 11 and the flexible film 12 can be achieved by bonding. Through chemical bonding, the edge of the flexible film 12 is sealed to one end face of the base 11, so that the flexible film 12 and one end face of the base 11 enclose a sealed air cavity 14. The air inflation element 21 keeps the flexible film 12 in a certain state of inflation, so that the flexible film 12 can better fit the uneven treatment area, and the treatment head can be applied to a wider range of treatment scenarios.

[0053] In one example, the connection between the base 11 and the flexible membrane 12 can also be achieved by using a mechanical seal with a sealing ring. A groove is provided on the surface of the base 11, and the sealing element can be a sealing ring or a sealing strip. The edge of the flexible membrane 12 and the sealing element are placed in the groove in sequence, and the sealing element and the edge of the flexible membrane 12 are pressed against the bottom of the groove by a locking ring provided at the groove opening, thereby achieving a mechanical seal between the flexible membrane 12 and the base 11.

[0054] It is understandable that the connection between the base 11 and the flexible film 12 can also be a combination of the two connection methods mentioned above. First, the edge of the flexible film 12 is bonded to the bottom of the groove, then the sealing element is placed in the groove, and finally, the sealing element and the edge of the flexible film 12 are pressed against the bottom of the groove by the locking ring set at the groove opening, so as to achieve mechanical sealing and adhesive sealing between the flexible film 12 and the base 11. This is used to firmly and seal the flexible film 12, and prevent the flexible film 12 from shifting or falling off during use, which would cause the air chamber 14 to leak air and thus affect the normal use of the treatment head.

[0055] In one embodiment of the present invention, the flexible electrode 13 is disposed in the air-filled cavity 14 and connected to a surface of the flexible film 12 facing the base 11.

[0056] In this embodiment, the flexible electrode 13 is disposed on the inner surface of the flexible film 12, that is, inside the air cavity 14. The flexible electrode 13 indirectly contacts the skin surface of the treatment site through the flexible film 12, which can better control the treatment temperature of the skin surface and prevent skin burns.

[0057] In one embodiment of the present invention, the flexible electrode 13 includes a plurality of sub-flexible electrode sheets spaced apart on the flexible film; or, the flexible electrode 13 is a complete electrode sheet, and the flexible electrode 13 extends along the length direction of the flexible film 12.

[0058] In this embodiment, the flexible electrode 13 may comprise multiple sub-flexible electrodes, which are evenly distributed along the surface of the flexible film to achieve uniform treatment of the treatment site. It is understood that in other embodiments, the flexible electrode 13 may be a single flexible electrode sheet extending along the length of the flexible film 12 and having a size slightly smaller than that of the flexible film 12, so that the entire flexible electrode 13 can be covered by the flexible film 12, preventing the flexible electrode 13 from being too long and causing overtreatment of the tissue adjacent to the treatment site.

[0059] In one embodiment of the present invention, the electrode assembly 10 further includes a gas pressure sensor 15 and a contact pressure sensor. The gas pressure sensor 15 is disposed on the flexible film 12 and is used to detect the gas pressure in the inflation chamber 14. The contact pressure sensor is disposed on the flexible film 12 and is used to detect the contact pressure between the flexible film 12 and the surface to be treated.

[0060] In other embodiments, the electrode assembly 10 further includes a temperature sensor 16 disposed on the surface of the flexible electrode 13 facing the base 11 and used to detect the temperature of the flexible electrode 13.

[0061] In a preferred embodiment, the electrode assembly 10 includes a gas pressure sensor 15, a contact pressure sensor, and a temperature sensor 16.

[0062] In this embodiment, a gas pressure sensor 15 is also provided inside the inflation chamber 14 to detect the air pressure inside the inflation chamber 14. By controlling the inflation element 21 to inflate or de-inflate the inflation chamber 14, the air pressure inside the inflation chamber 14 is maintained within a reasonable range. The air pressure value inside the inflation chamber 14 ranges from 20 mmHg to 100 mmHg, for example, 20 mmHg, 40 mmHg, 60 mmHg, 80 mmHg, 100 mmHg, or any value within the above range. The pressure inside the inflation chamber 14 cannot be too high. If the air pressure is too high, the flexible film 12 will be stretched, making it difficult for the flexible film 12 to deform, and thus the flexible film 12 cannot adhere to the uneven treatment area, thereby affecting the treatment effect. The pressure inside the inflation chamber 14 cannot be too low either. If the air pressure is too low, the flexible film 12 will not be able to expand and bulge, and thus the flexible film 12 cannot adhere to the uneven treatment area, thereby affecting the treatment effect.

[0063] Furthermore, the contact pressure sensor can also detect the contact pressure between the flexible film 12 and the surface of the treatment area. By measuring the contact pressure, the degree of adhesion between the flexible film 12 and the surface of the treatment area can be determined, thereby determining the degree of adhesion between the flexible electrode and the surface of the treatment area. This avoids excessively high local energy density due to poor adhesion, which could damage the skin.

[0064] In one example, a temperature sensor 16 is also provided within the inflation chamber 14. The temperature sensor 16 is located on the surface of the flexible electrode 13 facing the base 11. The temperature sensor 16 is used to detect the temperature of the flexible electrode 13 to determine whether to adjust the energy output and prevent excessive local energy density. When the temperature of the flexible electrode 13 is too high, exceeding the burn temperature of human skin, the temperature sensor 16 will control the flexible electrode 13 to stop working to prevent skin burns. The temperature of the flexible electrode 13 is maintained within a reasonable range of 12°C to 42°C, such as 12°C, 15°C, 20°C, 25°C, 30°C, 35°C, 40°C, 42°C, or any value within the above range, to adapt to different treatment requirements. The temperature of the flexible electrode 13 cannot be too high, as this will burn the skin at the treatment site; the temperature of the flexible electrode 13 cannot be too low, as this will result in insufficient treatment effect. The temperature maintenance mentioned here means maintaining the flexible electrode at this temperature for at least 1 second.

[0065] In one embodiment of the present invention, the gas filled into the inflation chamber 14 by the inflation element 21 is a cooling gas, which is used to reduce the temperature of the flexible electrode 13.

[0066] In this embodiment, the gas injected into the inflation chamber 14 is a cooling gas. The cooling gas helps to lower the temperature of the flexible electrode 13, preventing the flexible electrode 13 from overheating and causing burns to the skin surface of the treatment area. The cooling gas can be cooled nitrogen or cooled air, or it can be the vaporization of a coolant. When the coolant is sprayed out through a spray device, the coolant will evaporate rapidly. During the evaporation process, the coolant changes from a liquid state to a gaseous state, which can absorb a large amount of heat. The coolant material includes, for example, tetrafluoroethane, chloroethane, etc.

[0067] The present invention also proposes a therapeutic handpiece, comprising a handle and an electrode assembly as described above. The electrode assembly is disposed on the handle and electrically connected to the circuit board of the handle. The electrode assembly 10 may be detachably connected to other parts of the therapeutic handpiece for easy replacement, or it may be non-detachably connected to other parts of the therapeutic handpiece.

[0068] In this embodiment, the treatment handpiece includes a handle and an electrode assembly 10 as described above. The electrode assembly 10 is disposed on the handle and electrically connected to a circuit board inside the handle. The circuit board of the handle supplies power to the flexible electrodes 13 of the electrode assembly 10 to perform electrical stimulation treatment on the treatment area. In a preferred embodiment, a small air pump is integrated inside the handle. The air pump is connected to the inflation chamber of the electrode assembly to inflate or deflate the inflation chamber to maintain the air pressure value inside the inflation chamber.

[0069] Please see Figure 2The present invention also proposes an electrotherapy device 100, including a main unit 20 and a treatment hand as described above. The main unit 20 includes an electronic control element and an inflation element 21. The electronic control element is electrically connected to the flexible electrode 13 and the inflation element 21. The inflation element 21 is connected to the inflation chamber 14.

[0070] In this embodiment, the electrotherapy device 100 includes a main unit 20 and a treatment handpiece. The main unit 20 includes an electronic control element and an inflation element 21. The electronic control element is electrically connected to the flexible electrode 13 of the electrode assembly 10 of the treatment handpiece and the inflation element 21, respectively. The electronic control element can control the working state of the flexible electrode 13, thereby adjusting the energy output density of the flexible electrode 13. It can also control the inflation element 21 to fill the inflation chamber 14 with gas or extract gas from the inflation chamber 14, thereby controlling the inflation and expansion state of the flexible film 12, thereby adjusting the fit between the flexible film 12 and the treatment area, and improving the treatment effect of the treatment head.

[0071] Please see Figure 3 The present invention also proposes a control method applied to the electrotherapy device 100 described above, the electrotherapy device 100 being used to treat a target surface, the control method comprising the following steps:

[0072] Step S1: Control the inflation element 21 to fill the inflation chamber 14 with gas so that the inflation chamber 14 is in an inflated state;

[0073] Step S2: Control the flexible film 12 to abut against the target surface, and deform the flexible film 12 and the flexible electrode 13 to fit the target surface;

[0074] Step S3: Control the flexible electrode 13 to output electrical energy.

[0075] In this embodiment, before treatment, the inflation element 21 is controlled to fill the inflation chamber 14 with a preset volume of gas. The preset volume of gas can keep the flexible film 12 in a certain inflated state. During treatment, the electrode is attached to the treatment site by external force. The flexible electrode 13 and the flexible film 12 will deform according to the curvature of the treatment site and fit tightly to the surface of the treatment site. Then the treatment begins, and the flexible electrode 13 is controlled to output electrical energy toward the skin surface of the treatment site. The electrical energy includes radio frequency energy and / or electrical stimulation energy to treat the treatment site. The radio frequency energy can act on the dermis and the electrical stimulation energy can act on the muscle layer.

[0076] In one embodiment of the present invention, the electrotherapy device 100 further includes a gas pressure sensor disposed in the inflation chamber 14, a contact pressure sensor disposed in the flexible film 12, and a temperature sensor 16. After step S3 of controlling the output of electrical energy from the flexible electrode 13, the device further includes:

[0077] Step S4: Obtain the air pressure value inside the inflation chamber 14;

[0078] Step S5: Obtain the contact pressure value between the flexible film 12 and the target surface;

[0079] Step S6: If the air pressure value is lower than the first air pressure threshold, control the inflation element 21 to fill the inflation chamber 14 with gas until the air pressure value is higher than the first air pressure threshold.

[0080] Step S7: If the air pressure value is higher than the second air pressure threshold, control the inflation element 21 to extract gas from the inflation chamber 14 until the air pressure value is lower than the second air pressure threshold.

[0081] Step S8: If the contact pressure value is lower than the contact pressure threshold, control the inflation element to fill the inflation chamber with gas until the gas pressure value is higher than the contact pressure threshold.

[0082] In this embodiment, during the treatment process, the gas pressure sensor 15 installed in the inflation chamber 14 detects the gas pressure value in the inflation chamber 14 in real time to determine whether it is necessary to perform a gas replenishment or de-gas operation in the inflation chamber 14. The contact pressure sensor obtains the contact pressure between the flexible film 12 and the surface to be treated to determine whether the flexible film 12 is well attached to the surface of the treatment area. If the gas pressure value is lower than the first gas pressure threshold, which can be 20 mmHg to 40 mmHg, such as 20 mmHg, 30 mmHg, 40 mmHg or any value in the above range, the flexible film 12 will not be able to expand and bulge, thus preventing the flexible film 12 from adhering to the uneven treatment area and affecting the treatment effect. In this case, the inflation element 21 is controlled to fill the inflation chamber 14 with gas to raise the gas pressure value in the inflation chamber 14 to a suitable range.

[0083] When the amount of gas injected causes the air pressure value to exceed the second air pressure threshold, which can be 95 mmHg to 105 mmHg, such as 95 mmHg, 100 mmHg, 105 mmHg or any value within the above range, the flexible film 12 will become taut and unable to adhere to the uneven treatment area, thus affecting the treatment effect. In this case, the inflation element 21 is controlled to extract gas into the inflation chamber 14 to reduce the air pressure value in the inflation chamber 14 to a suitable range.

[0084] In one embodiment of the present invention, after step S3 of controlling the output electrical energy of the flexible electrode, the method further includes:

[0085] Step S9: Obtain the temperature of the flexible electrode 13;

[0086] Step S10: If the temperature is higher than the temperature threshold, control the inflation element 21 to fill the inflation chamber 14 with cooling gas until the temperature is lower than the temperature threshold.

[0087] In this embodiment, during the treatment process, the temperature of the flexible electrode 13 is detected in real time by the temperature sensor 16 to determine whether to adjust the energy output and whether there is excessive energy density in a local area. If the temperature is higher than the temperature threshold, that is, the heat resistance temperature of the skin at the treatment site, for example, 50°C, the inflation element 21 can fill the inflation chamber 14 with cooling gas to lower the temperature of the flexible electrode 13 and prevent skin burns.

[0088] It is understood that in this application, the electrical energy output through the flexible electrode can be high-frequency radio frequency energy or medium- and low-frequency electrical stimulation energy.

[0089] The above description is merely an exemplary embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention specification and drawings under the technical concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. An electrode assembly for use in an electrotherapy device, characterized in that, The electrode assembly includes: The base is made of a rigid material; A flexible film, the edge of which is sealed to one end face of the base to form an inflation cavity, the inflation cavity being connected to an external inflation element to have both a deflated state and an inflated state with gas filling; and A flexible electrode is attached to one surface of the flexible film.

2. The electrode assembly as described in claim 1, characterized in that, The flexible film is made of one of the following materials: polyimide, polyethylene terephthalate, or polydimethylsiloxane.

3. The electrode assembly as described in claim 1, characterized in that, The flexible electrode is made of one or more of the following materials: polyaniline, polyacetylene, polypyrrole, polythiophene, and graphene nanocomposite.

4. The electrode assembly as claimed in claim 1, characterized in that, A groove is provided on one end face of the base, and a locking ring is provided at the opening of the groove. The edge of the flexible film is connected to the bottom wall of the groove. A sealing element is also provided in the groove. The sealing element is arranged around the periphery of the flexible film. The locking ring presses the sealing element and the edge of the flexible film against the bottom of the groove.

5. The electrode assembly as described in any one of claims 1 to 4, characterized in that, The flexible electrode is disposed inside the air-filled cavity and connected to a surface of the flexible film facing the base.

6. The electrode assembly as described in any one of claims 1 to 4, characterized in that, The flexible electrode includes a plurality of sub-flexible electrode sheets spaced apart from the flexible film; Alternatively, the flexible electrode may be a single, continuous electrode that extends along the length of the flexible film.

7. The electrode assembly as claimed in any one of claims 1 to 4, characterized in that, The electrode assembly also includes a gas pressure sensor and a contact pressure sensor. The gas pressure sensor is disposed on the flexible film and is used to detect the gas pressure in the inflation chamber. The contact pressure sensor is disposed on the flexible film and is used to detect the contact pressure between the flexible film and the surface to be treated. And / or, the electrode assembly further includes a temperature sensor disposed on the surface of the flexible electrode facing the base, and used to detect the temperature of the flexible electrode.

8. The electrode assembly as described in any one of claims 1 to 4, characterized in that, The gas introduced into the inflation chamber by the inflation element is a cooling gas, which is used to reduce the temperature of the flexible electrode.

9. A therapeutic hand tool, characterized in that, The therapeutic handpiece includes a handle and an electrode assembly as described in any one of claims 1 to 8, the electrode assembly being disposed on the handle and electrically connected to the circuit board of the handle.

10. An electrotherapy device, characterized in that, The electrotherapy device includes a main unit and a handle as described in claim 9. The main unit includes an electronic control element and an inflation element. The electronic control element is electrically connected to the flexible electrode and the inflation element, respectively. The inflation element is in communication with the inflation chamber.

11. A control method applied to the electrotherapy device as described in claim 10, characterized in that, The electrotherapy device is used to treat a target surface, and the control method includes the following steps: The inflation element is controlled to inflate the inflation chamber with gas, so that the inflation chamber is in the inflated state. The flexible film is controlled to abut against the target surface, and the flexible film and the flexible electrode deform to conform to the target surface; Control the output of electrical energy from the flexible electrode.

12. The control method as described in claim 11, characterized in that, The electrotherapy device further includes a gas pressure sensor disposed in the inflation chamber, a contact pressure sensor disposed in the flexible film, and a temperature sensor. After the step of controlling the output of electrical energy from the flexible electrode, the device further includes: Obtain the air pressure value inside the inflation chamber; Obtain the contact pressure value between the flexible film and the target surface; If the air pressure value is lower than the first air pressure threshold, the inflation element is controlled to fill the inflation chamber with gas until the air pressure value is higher than the first air pressure threshold. If the air pressure value is higher than the second air pressure threshold, the inflation element is controlled to extract the gas from the inflation chamber until the air pressure value is lower than the second air pressure threshold. If the contact pressure value is lower than the contact pressure threshold, the inflation element is controlled to fill the inflation chamber with gas until the gas pressure value is higher than the contact pressure threshold.

13. The control method as described in claim 11, characterized in that, After the step of controlling the output of electrical energy from the flexible electrode, the method further includes: Obtain the temperature of the flexible electrode; If the temperature is higher than the temperature threshold, the inflation element is controlled to fill the inflation chamber with the cooled gas until the temperature is lower than the temperature threshold.

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