Treatment apparatus using RF energy and control method thereof
The RF energy treatment device addresses inconsistent energy delivery by using a monitoring and control system to adjust RF pulses, ensuring uniform treatment by maintaining a constant energy level despite tissue variations.
Patent Information
- Application Number
- PCT/KR2025/006453
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-20
- Filing Date
- 2025-05-13
- Publication Date
- 2025-12-26
AI Technical Summary
Existing RF energy-based tissue treatment technologies struggle to achieve uniform treatment due to varying tissue characteristics, leading to inconsistent energy delivery and potential overtreatment or undertreatment.
A treatment device using RF energy with a monitoring unit to measure current values and a control unit to adjust RF pulse width and energy delivery, ensuring a constant amount of energy is delivered to the tissue despite varying tissue impedance.
The device ensures uniform treatment by minimizing overtreatment and undertreatment, optimizing energy delivery based on real-time monitoring and control of RF pulses.
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Figure KR2025006453_26122025_PF_FP_ABST
Abstract
Description
Treatment device using RF energy and control method thereof
[0001] The present invention relates to a treatment device using RF energy and a control method thereof, and more particularly, to a treatment device using RF energy that treats tissue by applying RF pulses to the tissue and a control method thereof.
[0002] Techniques for treating tissue lesions by delivering RF energy to a patient's skin have been developed in various ways. In particular, recent technologies have been developed that treat tissue without damaging the skin surface by cooling the skin with electrodes placed on the skin surface and delivering RF energy. These RF energy-based treatment techniques are disclosed in Korean Patent No. 0706115, among others.
[0003] Treatment using this RF energy involves delivering the required amount of energy to the tissue. However, even when applying RF energy at the same output, the way energy is delivered to the tissue varies depending on its characteristics, making it difficult to achieve uniform treatment.
[0004] The present invention provides a treatment device using RF energy and a control method thereof that can uniformly perform treatment even when the characteristics of the tissue are different when treating the tissue using RF energy.
[0005] In order to achieve the above-described object of the present invention, the present invention provides a treatment device using RF, including an RF generator, an electrode unit that contacts the skin of a patient and applies RF pulses generated from the RF generator, a return unit that contacts the skin of the patient at a position opposite to the electrode unit and returns the RF pulses applied from the electrode unit, and a control unit that controls parameters of the RF pulses so that a preset amount of energy is transmitted to tissue by each RF pulse.
[0006] The control unit controls the pulse width of the RF pulse so that a preset amount of energy is delivered to the tissue by each RF pulse.
[0007] A treatment device using RF energy further includes a monitoring unit for monitoring the amount of energy delivered to tissue by the RF pulse.
[0008] The monitoring unit measures the current value passing through the electrode unit or the return unit, and determines the amount of energy delivered to the tissue by the RF pulse based on the measured current value. For example, the monitoring unit can measure the current value returned from the return unit, and determine the amount of energy delivered to the tissue by the RF pulse based on the measured current value.
[0009] And, it further includes a setting unit that sets a target energy to be delivered to the tissue with an RF pulse, and the RF generation unit generates an RF pulse having energy exceeding the target energy, and the control unit is configured to control the RF pulse to be terminated when energy corresponding to the target energy is delivered to the tissue by the RF pulse. Here, the RF generation unit may be configured to generate an RF pulse having energy in a range of 1.2 to 3 times the target energy.
[0010] The RF pulses applied to the tissue are configured to deliver the same energy to the tissue, but the RF pulse width is variable by the control unit. In addition, the control unit is configured to individually control the end point of each RF pulse.
[0011] The monitoring unit measures the current value returned from the return unit, and the control unit E0 = i 2 ·z·t0 (E0: target energy, i: current value, z: impedance of tissue) can be controlled to terminate the RF pulse at t0.
[0012] Alternatively, the monitoring unit measures the current value returned from the return unit, and the control unit The RF pulse can be controlled to end at t0, which satisfies (E0: target energy, i: current value, z: impedance of tissue).
[0013] Meanwhile, the above-described object of the present invention can also be achieved by a control method for a treatment device using RF, which includes a step of transmitting RF pulses generated from an RF generator to tissue using an electrode unit and a return unit each placed in contact with the patient's skin, a step of monitoring energy transmitted to the tissue by the RF pulses, and a step of controlling a parameter of the RF pulses so that the energy transmitted to the tissue by each RF pulse is constant.
[0014] Here, the step of adjusting the parameters of the RF pulse adjusts the end point of the RF pulse.
[0015] The monitoring step measures the current value returned from the return unit and determines the energy delivered to the tissue by the RF pulse based on the measured current value.
[0016] In addition, the present control method further includes a step of setting a target energy value to be delivered to the tissue by each RF pulse.
[0017] An RF pulse generated from an RF generator has energy exceeding a set target energy, and when energy corresponding to the target energy is transmitted to the tissue by the RF pulse, the control unit controls the RF pulse to be terminated.
[0018] Therefore, the RF pulse applied to the tissue delivers a constant amount of energy to the tissue, but each pulse width is variable.
[0019] Meanwhile, in order to achieve the above-mentioned object, the present invention provides a treatment device using RF, including an RF generator, an electrode unit that contacts the patient's skin and applies RF pulses generated from the RF generator, a return unit that contacts the patient's skin at a position opposite to the electrode unit and returns the RF pulses applied from the electrode unit, and a control unit that controls each RF pulse to deliver energy of a constant size to tissue while varying the pulse width of the RF pulse.
[0020] According to the present invention, uniform treatment can be performed by monitoring the energy actually transferred to the tissue while the RF pulse is applied and controlling the pulse width to transfer a constant amount of energy to the tissue.
[0021] In addition, even when the energy absorption pattern differs depending on the characteristics of the patient or tissue, optimal treatment is possible by minimizing overtreatment and undertreatment by delivering a constant amount of energy.
[0022] Figure 1 is a perspective view illustrating a treatment device using RF energy according to one embodiment of the present invention.
[0023] Figure 2 is a block diagram showing the main configuration of the treatment device according to Figure 1;
[0024] Figure 3 is a perspective view showing the handpiece of Figure 1;
[0025] Fig. 4 is an exploded perspective view showing the main configuration of the tip module of Fig. 3;
[0026] Fig. 5 is a cross-sectional view showing the main configuration of the tip module of Fig. 3;
[0027] Fig. 6 is a circuit diagram showing an RF circuit formed when treating a patient using the treatment device of Fig. 1.
[0028] Figure 7 is a graph showing the RF energy transfer characteristics for the patient's characteristics when the same RF pulse is applied.
[0029] Figure 8 is a block diagram showing the main components related to the control of RF pulses in the treatment device of Figure 1.
[0030] Figure 9 is a graph showing the current value measured in the monitoring unit and the amount of energy transferred to the tissue.
[0031] Figure 10 is a graph showing the termination time according to the reference RF pulse and energy transfer efficiency.
[0032] Figure 11 is a graph showing the current value measured in the monitoring unit and the amount of energy transferred to the tissue in another embodiment;
[0033] Fig. 12 is a graph showing an example of RF pulses continuously irradiated through the treatment device of Fig. 1.
[0034] Figure 13 is a flowchart illustrating a control method of the treatment device of this embodiment.
[0035] Figure 14 is a flowchart illustrating the treatment steps of Figure 13 in more detail.
[0036] Hereinafter, with reference to the drawings, a treatment device utilizing RF energy, its handpiece, and its tip module according to an embodiment of the present invention will be described in detail. In the following description, the positional relationship of each component is explained in principle based on the drawings. In addition, the drawings may simplify the structure of the invention or, if necessary, exaggerate it for convenience of explanation. Therefore, the present invention is not limited thereto, and it goes without saying that various devices can be added, modified, or omitted in addition to these.
[0037] Hereinafter, the term "treatment device using RF energy" refers to a medical RF device, and is an RF transmission device that transmits RF energy for the purpose of treatment. It also includes all devices for treating mammals, including humans. The treatment device may include various devices that transmit RF energy for the purpose of improving the condition of a lesion or tissue. The following embodiment will focus on a device for treating skin lesions. For example, it may mean that RF energy is used to locally heat skin tissue to improve wrinkles, tone and textural changes, scars and acne scarring, sagging mucosa, overall rejuvenation, hyperhidrosis, laxity, lifting, tightening, fat reduction, etc. However, it should be noted that the present invention is not limited thereto, and can be applied to various devices that transmit RF energy to various affected areas, including devices for surgically treating lesions of internal organs.
[0038] Hereinafter, "tissue" refers to the collection of cells that make up the various bodily organs of animals, including humans. This includes the skin tissue of the face, neck, arms, legs, and torso, as well as various tissues that make up various organs within the body.
[0039] Hereinafter, a treatment device according to one embodiment of the present invention will be described with reference to the drawings.
[0040] Fig. 1 is a perspective view illustrating a treatment device using RF energy according to one embodiment of the present invention. The treatment device of Fig. 1 is, as an example, a medical RF device for treating a patient's skin tissue, which uses RF energy as an energy source for treatment and is an RF transmission device that transmits RF energy to a treatment location.
[0041] As illustrated in FIG. 1, the treatment device according to the present embodiment includes a main body (10), a handpiece (20) connected to the main body (10), and a return unit (30). The main body (10) is provided with various components for operating the treatment device of the present embodiment. On the outer surface of the main body (10), a setting unit for setting the treatment operation and treatment mode of the treatment device and a display unit for displaying treatment-related information to the user are provided. Components such as an RF generation unit (50) and a refrigerant storage unit may be provided inside the main body (10).
[0042] The handpiece (20) is a component that performs treatment at a treatment location and is provided in a form that a user can hold in his or her hand and use. An electrode (141) that contacts the patient's skin surface and transmits RF energy is provided at one end of the handpiece (20). Various operating parts for manipulating the treatment motion may be provided on the outer surface of the handpiece (20), and a conductive path for transmitting RF energy to the electrode (141) and a cooling channel for cooling the electrode are provided on the inside of the handpiece (20).
[0043] The return portion (30) is configured in the form of a pad containing a return electrode. The return electrode is composed of a conductive material and is positioned so as to contact a location on the patient's body opposite the treatment location where the electrode of the handpiece contacts the patient's body during treatment. Therefore, when RF energy is applied, the return electrode, together with the electrode (141) of the handpiece, forms a path through which RF energy is transmitted to the patient's body.
[0044] As illustrated in Fig. 1, the handpiece (20) and the return portion (30) are each connected to the main body by a connecting portion. The connecting portion may be formed of a cable or the like, and each is electrically connected to the main body to form an RF transmission path and is configured to transmit or receive various signals.
[0045] In this embodiment, the electrode (141) of the handpiece is configured as a monopolar type having a single polarity and is provided with a separate return portion; however, the present invention is not limited thereto. As another example, if the handpiece is configured as a bipolar type having electrodes of different polarities, the handpiece may be implemented without including the aforementioned return electrode pad.
[0046] Figure 2 is a block diagram illustrating the main components of the treatment device according to Figure 1. The RF generator (50) generates RF energy as energy used for treatment. The RF generator (50) generates RF pulses having various parameters depending on the patient's constitution, treatment purpose, treatment area, etc. The parameters may be at least one of output, pulse duration, pulse interval, and frequency.
[0047] The RF generator (50) of the present embodiment can generate RF energy having at least two different frequencies. That is, the RF generator (50) can selectively generate RF energy having a first frequency and RF energy having a second frequency. Here, the frequency ranges can be divided into a first range (2 MHz or more and less than 6 MHz), a second range (6 MHz or more and less than 10 MHz), and a third range (10 MHz or more and 30 MHz or less) according to the penetration characteristics into the tissue. In this case, the first range is a frequency range having superior skin penetration characteristics compared to the second and third ranges, and the third range is a frequency range having inferior skin penetration characteristics compared to the first and second ranges. In this case, the first frequency may be a frequency within the first range, and the second frequency may be a frequency within the second range. Alternatively, the first frequency may be a frequency within the first range, and the second frequency may be a frequency within the third range. Alternatively, the first frequency may be a frequency within the second range, and the second frequency may be a frequency within the third range. When the RF generator (50) can generate RF energy of three different frequencies, the first frequency may be a frequency within a first range, the second frequency may be a frequency within a second range, and the third frequency may be a frequency within a third range.
[0048] The RF generator (50) can be controlled to generate RF energy having a selected frequency or RF energy combining RF pulses of multiple frequencies, depending on the progress of the selected treatment mode or treatment process, but with different frequency ratios.
[0049] The electrode unit (141) is connected to the RF generator unit (50) via an RF circuit and is configured to transmit RF energy generated from the RF generator unit to the patient's tissue. The electrode unit (141) is provided at one end of the handpiece (20) and is positioned so as to contact the patient's skin tissue when in use. In addition, it forms an RF circuit that passes through the patient's tissue together with the return unit (30) positioned so as to contact the patient's skin at an opposite position, and transmits RF energy to the patient's tissue.
[0050] In addition, the monitoring unit (35) is configured to monitor RF energy transmitted to the patient's tissue. The monitoring unit (35) monitors by measuring at least one RF parameter on the path of the RF circuit formed by the RF generation unit (50), the electrode unit (141), and the return unit (30), and calculating the RF energy transmitted to the tissue based on the measured RF parameter. The electrode unit (141) and the monitoring unit (35) are described in more detail below with reference to separate drawings.
[0051] The cooling unit (60) is configured to cool the treatment location where treatment is performed by the handpiece. The cooling unit (60) can utilize various cooling methods, and as an example, the cooling unit (60) of the present embodiment is configured to cool the treatment location using the heat of vaporization of a liquid refrigerant. The cooling method using the refrigerant can also cool the treatment location by directly spraying the refrigerant onto the treatment location, but in the present embodiment, the refrigerant is sprayed onto the rear of the electrode (141) that comes into contact with the treatment location during treatment to indirectly cool the treatment location. In this case, the skin surface in contact with the electrode (141) is cooled, thereby preventing the skin surface from being thermally damaged during treatment.
[0052] Specifically, the cooling unit (60) includes a refrigerant receiving portion that receives refrigerant, a cooling channel that forms a path through which the refrigerant received in the refrigerant receiving portion is delivered, and a cooling module that sprays the refrigerant delivered through the cooling channel to the rear surface of the electrode of the handpiece. The refrigerant receiving portion is provided in the main body or in a separate location. The cooling channel is connected from the refrigerant receiving portion to the cooling module, and at least a portion of the cooling channel is provided inside the handpiece. The cooling channel comprises at least one valve and sensor, and the control unit monitors the cooling process of the cooling unit (60) and controls the cooling performance using the same. Here, the cooling performance refers to the performance that can lower the temperature of the object for the same period of time, and may be the amount of refrigerant sprayed per unit time through the cooling module.
[0053] The sensing unit (80) is a component that senses various information necessary for the operation of the treatment device during, before, or after treatment. For example, the sensing unit (80) may be at least one of an impedance sensor that measures the impedance of a tissue, a temperature sensor (142) that measures the temperature of an electrode or skin, a contact sensor that detects whether the electrode of the handpiece is in contact with the skin surface, a movement sensor that detects the movement speed of the handpiece, and a pressure sensor that detects the pressure of a cooling channel. As an example, in the present embodiment, a temperature sensor (142) and a contact sensor (not shown) are arranged adjacent to the electrode of the handpiece, and a pressure sensor for monitoring the pressure at which a refrigerant is provided may be arranged in the cooling channel.
[0054] The setting unit (70) is provided in the main body and is configured to set various operations of the treatment device, including the treatment mode. The user can set the treatment mode to be performed through the setting unit (70). Specifically, the user can set at least one of the target energy to be delivered to the tissue using RF pulses, the number of pulses, the pulse width, and the frequency characteristics constituting the pulses through the setting unit (70). Alternatively, the treatment lesion, the target tissue to be treated, the target depth, etc. can be set.
[0055] The storage unit (90) is configured to store various information required for treatment and includes a memory element. The storage unit (90) is provided in the main body (10) and may additionally be provided in the handpiece (20) or the tip module (100). The storage unit (90) can store parameter information for each treatment mode, patient-related information, control information according to sensed conditions, etc. In addition, the storage unit can update and record information sensed during treatment and information input by the user. In addition, the memory provided in the handpiece (20) or the tip module (100) can be configured to store identification information for the handpiece or the tip module.
[0056] The control unit (40) is a component that controls the operation of various components of the treatment device, such as the RF generator (50) and the cooling unit (60). For example, the control unit (40) controls various components using the contents set by the user through the setting unit (70) or the control information stored in the storage unit (90). The control unit receives information sensed from the sensing unit (80) and information monitored from the monitoring unit (35), and controls various components using the received information. For example, the control unit (40) receives a temperature value sensed by a temperature sensor and controls the parameters of the RF pulse and the cooling performance for the electrode based on the temperature value. Alternatively, the control unit (40) controls the parameters of the RF pulse based on the information monitored by the monitoring unit. Here, the control unit (40) is configured to include a calculation unit, and can calculate a control value using the received information using a preset algorithm, and control various components based on the control value.
[0057] Fig. 3 is a perspective view illustrating the handpiece of Fig. 1. As illustrated in Fig. 3, the handpiece (20) comprises a main body (21) and a tip module (100). One end of the main body (21) is connected to a connecting portion, and various components for performing a treatment operation, such as an RF transmission circuit and a cooling path, are provided inside. An operation portion and a display portion, such as a display, may be provided on the outer surface of the main body (21). The tip module (100) is provided with an electrode (141) for transmitting RF energy by contacting the skin, and is detachably coupled to one end of the main body (21). The tip module (100) is provided with a circuit for transmitting RF energy to the electrode and a cooling structure for cooling the electrode and the treatment site. Hereinafter, the structure of the tip module will be described in more detail with reference to Figs. 4 and 5.
[0058] Fig. 4 is an exploded perspective view illustrating the main configuration of the tip module of Fig. 3, and Fig. 5 is a cross-sectional view illustrating the main configuration of the tip module of Fig. 3. Referring to Figs. 4 and 5, the tip module is configured to include a tip housing (110), an electrode module (140), a cooling module (150), an internal case (120), and a rear cover (130).
[0059] The tip housing (110) and the inner case (120) are coupled to each other to support the electrode module (140). A cooling module (150) is arranged inside the inner case (120). The rear cover (130) is coupled to the rear of the tip housing (110) while the electrode module (140), the inner case (120), and the cooling module (150) are arranged inside the tip housing (110). The tip housing (110) or the rear cover (130) is provided with a coupling structure for being fastened to the end of the main body (21) of the handpiece.
[0060] As illustrated in FIG. 4, the electrode module (140) is configured as a flexible substrate that is foldable, and an electrical element and a circuit for electrically forming the same are formed therein. The electrode (141) is arranged at the front of the electrode module (based on the state in which the electrode module is folded) and is exposed through the opening of the tip housing (110) to come into contact with the skin surface. The electrode (141) is configured to include a conductive layer formed on the flexible substrate, and the conductive layer is configured to be covered by a dielectric layer. Therefore, during treatment, the conductive layer of the electrode comes into contact with the skin through the dielectric layer, and when RF energy is applied to the electrode, the electrode transmits the RF energy to the skin tissue while being capacitively coupled with the skin tissue by the dielectric layer.
[0061] Meanwhile, as described above, the temperature sensor (142) and the contact sensor of the sensing unit are provided at a position adjacent to the electrode (141) among the electrode modules (140) to measure the temperature of the electrode or the skin surface and detect whether the electrode is in contact with the skin. In addition, the electrode module (140) further includes a memory, and the memory can store information of the tip module, such as the type of electrode, the size of the electrode, the pattern of the electrode, the size of the cooling space, etc. The electrode module (140) is provided with a conductive lead that extends rearward and is connected to the electrode, each sensor, and the memory described above. A terminal formed at the end of the conductive lead is exposed rearward when the rear cover (130) is coupled, and is electrically connected to the RF circuit on the main body (21) side of the handpiece when the tip module (100) is coupled.
[0062] And, as described above, the cooling module (150) is configured to spray the refrigerant delivered from the refrigerant receiving portion (210) along the cooling passage (201) to the rear of the electrode (141). A conduit having a cooling passage formed therein is provided on the rear side of the cooling module (150), and a plurality of injection holes (151) are provided on the front side of the cooling module (150). The rear end of the conduit is exposed to the rear side of the rear cover (130) when the tip module (100) is assembled. Therefore, when the tip module (100) is coupled to the main body (21) of the handpiece, the cooling passage of the conduit is coupled with the cooling passage on the main body (21) side to form a path through which the refrigerant provided from the refrigerant receiving portion (210) is delivered.
[0063] The tip module (100) having such a structure is detachably coupled to the main body end of the handpiece as described above. When the tip module (100) is coupled, the control unit (40) receives information about the tip module from the memory of the tip module (100), and controls the RF generator (50) and the cooling unit (60) in consideration of the information to transmit RF energy to the electrode of the tip module (100) and perform a process of cooling the electrode. In addition, the tip module (100) may be configured as a consumable, and may be replaced with a new tip module (100) when treating a new patient or exceeding the allowed number of uses.
[0064] The treatment device using RF energy described above is at least partially electrically connected to the patient's body to form an RF circuit, and transmits RF energy to the patient's tissue through this to perform treatment.
[0065] Figure 6 is a schematic circuit diagram of an RF circuit formed during patient treatment using the treatment device of Figure 1. The aforementioned RF energy-using treatment device forms an RF circuit by electrically connecting at least a portion of the device to the patient's body, thereby transmitting RF energy to the patient's tissues to perform treatment.
[0066] Specifically, the electrode unit (141) provided at the end of the handpiece comes into contact with one side of the patient's skin surface by the user's treatment motion during treatment. In addition, the return electrode of the return unit (30) comes into contact with the patient's skin surface at a position opposite to the electrode unit (141). The electrode unit (141) of the handpiece (20) is connected to the RF generator unit (50) provided in the main body through a connection unit. In addition, the return electrode of the return unit (30) is connected to a separate ground unit.
[0067] Accordingly, when treating a patient using a treatment device, an RF circuit such as that shown in FIG. 6 is formed. Here, the patient's body comes into contact with the electrode unit (141) and the return unit (30) and is capacitively coupled therewith. That is, the electrode unit (141) and the return unit (30) act as a charge plate of the capacitive element, and the patient's tissue interposed between the electrode unit (141) and the return unit (30) acts as a dielectric of the capacitive element. Therefore, the electrode unit (141) connected to the RF generation unit (50) acts as an active electrode and applies an RF pulse to the inside of the patient's tissue, and the return unit (30) connected to the ground unit acts as a return electrode and forms a path along which the RF pulse applied to the inside of the tissue returns. Through the RF circuit formed in this way, an RF pulse is applied to the patient's tissue to transmit RF energy, and treatment of the tissue is performed by the transmitted RF energy.
[0068] Figure 7 is a graph illustrating the RF energy transfer characteristics for different patient characteristics when the same RF pulse is applied. In the case of a capacitive element, the manner in which RF energy is stored in the capacitive element varies depending on the impedance characteristics of the dielectric material interposed between conductive substrates even when the same RF energy is applied. Similarly, when treating with RF pulses, even when RF pulses of the same output are applied, the manner in which RF energy is transferred to the tissue, i.e., the manner in which RF energy is absorbed by the tissue, varies depending on the impedance characteristics of the tissue.
[0069] In Fig. 7, the RF pulse indicated by the dotted line is the RF pulse (P) generated from the RF generator. r ) is shown, and the RF pulses indicated by solid lines are RF pulses transmitted / absorbed in the tissues of each patient (P a , P b). The output of the RF pulse generated from the RF generator is applied equally to the tissues of patients A and B with a preset pulse width as an output for the reference impedance promised in the RF generator circuit (e.g., 50 ohm). Accordingly, the RF energy delivered to the tissues of each patient is delivered with different efficiencies depending on the impedance of the patient. The tissue of patient A has a relatively low impedance, and thus the RF energy is delivered to the tissue with high efficiency. In contrast, the tissue of patient B has a relatively high impedance, and the RF energy is delivered with relatively low efficiency. Therefore, even if an RF pulse with the same output and pulse is applied, the energy delivered to the tissue, that is, the efficiency with which the energy is delivered, is different depending on the impedance characteristics of the tissue.
[0070] In Fig. 7, it is explained that the energy transfer characteristics by RF pulses differ depending on the patient. However, even in the same patient, the impedance characteristics may differ depending on the type and location of the tissue, and thus the efficiency of energy transfer may differ. In addition, even when multiple RF pulses are applied to the same location, the efficiency of energy transfer may differ as the tissue absorbs energy and the tissue's state changes, causing the tissue's impedance to change. In this way, since the efficiency of energy transfer varies depending on the tissue's impedance, there is a concern that the therapeutic effect may differ even when RF pulses with the same parameters are applied from a treatment device.
[0071] To solve these problems, the present invention is configured to monitor the energy actually delivered to the tissue by the RF pulse rather than the energy of the RF pulse generated from the RF generator (50), and control the amount of energy delivered to the tissue based on this.
[0072] Fig. 8 is a block diagram illustrating the main components related to the control of RF pulses in the treatment device of Fig. 1. The block diagram further includes a monitoring unit (35) on an RF circuit formed by an RF generator (50), an electrode unit (141), and a return unit (30). The monitoring unit (35) monitors in real time the amount of energy of an RF pulse generated from the RF generator (50) and transmitted to the tissue through the electrode unit (141). In addition, the control unit (40) controls the RF generator (50) so that a certain amount of energy is transmitted to the tissue based on the information monitored by the monitoring unit (35).
[0073] Specifically, the monitoring unit (35) measures the current value passing through the electrode unit (141) or the return unit (30) on the aforementioned RF circuit. While the same RF pulse is applied from the RF generator (50), the voltage value between the electrode unit (141) and the return unit (30) is maintained constant, so that the impedance value of the tissue and the energy value transferred to the tissue can be determined using the measured current value. As an example, the monitoring unit (35) of the present embodiment is provided between the return unit (30) and the ground unit, and is configured to measure the current value returned to the return unit after passing through the tissue.
[0074] In addition, the control unit (40) is configured to receive monitored information from the monitoring unit (35). The control unit (40) receives the amount of energy transferred to the tissue from the monitoring unit (35) and controls the RF generator (50) to terminate the RF pulse when a preset amount of energy is transferred to the tissue. Therefore, even if the energy transfer efficiency differs due to differences in the impedance characteristics of the tissue, the target amount of energy can be transferred to the tissue at a constant level.
[0075] Hereinafter, with reference to FIGS. 9 to 11, the control of the end point of the RF pulse based on the monitoring results of the monitoring unit will be described in more detail.
[0076] Figure 9 is a graph illustrating the current value measured by the monitoring unit and the amount of energy delivered to the tissue. In the graph of Figure 9, the dotted line indicates the current value monitored over time while the RF pulse is applied, and the solid line indicates the energy value calculated by the current value, i.e., the energy value actually delivered to the tissue, i.e., the energy value absorbed by the tissue.
[0077] While the RF pulse is applied, a constant potential difference of v0 is formed between the electrode part (141) and the return part (30). When the impedance of the tissue is maintained constant at z0 while the RF pulse is applied, a current i0 of a constant magnitude is measured in the monitoring part (35) while the RF pulse is applied. The measured current value i0 is i0 = v0 / z0. And, since the value of v0 is maintained constant, the value of z0 is calculated as z0 = v0 / i0. The energy applied to the tissue while the RF pulse is transmitted is E(t) = i 2 0·z0·t, which increases linearly while the RF pulse is applied.
[0078] If the size of the target energy to be delivered to the tissue by one RF pulse is E0, the control unit (40) monitors the amount of energy delivered to the tissue through the monitoring unit (35), and E0 = i 2 The RF generator (50) is controlled so that the RF pulse ends at time t0, which satisfies 0·z0·t0.
[0079] Figure 10 is a graph showing the termination time according to the reference RF pulse and energy transfer efficiency. As described above, the control unit according to the present invention monitors the amount of energy transferred to the tissue in real time, and terminates the RF pulse when the target energy is transferred to the tissue. In Figure 10, the reference RF pulse (P r ) is represented by a dotted line, and the RF energy delivered to two tissues with different energy transfer efficiencies is represented by a solid line, respectively.
[0080] In Fig. 10, the vertical axis of the reference RF pulse indicated by the dotted line represents the output of the reference RF pulse (output based on the preset reference impedance), and the horizontal axis represents the reference pulse width (t) of the reference RF pulse. r ) is shown. And, the vertical axis of the RF pulse delivered to the tissue indicated by the solid line represents the efficiency of energy delivery per unit time, and the horizontal axis represents the point in time when the RF pulse application is terminated by the control unit.
[0081] Here, the reference RF pulse is a basic pulse form of the RF pulse generated from the RF generator (50). The reference RF pulse is configured to have a preset reference output and reference pulse width as described above. The RF generator (50) generates a reference RF pulse during treatment and applies it to the tissue, but the control unit (40) controls the end point of the RF pulse based on the amount of energy transferred to the tissue, so that the pulse width (t) of the RF pulse actually transferred to the tissue 0a , t 0b ) is the pulse width (t) of the reference RF pulse. r ) may be different. Therefore, the pulse widths of the RF pulse delivered to the tissue and the reference RF pulse in FIG. 10 are shown differently.
[0082] The pulse width of the reference RF pulse is set to the pulse interruption point (t) by the control unit, as shown in Fig. 10, so that the RF pulse can be interrupted by the control unit at the point when the energy corresponding to the target energy is delivered to the tissue. 0a , t 0b ) is formed longer than the reference RF pulse. The pulse width of the reference RF pulse can be determined to be sufficiently long considering the impedance range of typical patient tissues.
[0083] Additionally, the energy of the reference RF pulse (P in Fig. 10 rThe value corresponding to the area of (a) and (b) in Fig. 10) is set to have a value greater than the target energy to be delivered to the tissue by each RF pulse (the value corresponding to the area of (a) and (b) in Fig. 10). As an example, the energy of the reference RF pulse is set to have a value in the range of 1.2 to 3 times the target energy (E0). Therefore, it can be controlled to deliver target energy to tissues having various energy delivery efficiencies.
[0084] In Fig. 10, (a) illustrates an RF pulse being delivered to a tissue with relatively high energy transfer efficiency, and (b) illustrates an RF pulse being delivered to a tissue with relatively low energy transfer efficiency. Compared to (b), (a) has a relatively low impedance and a high current value monitored by the monitoring unit. Therefore, when the same reference RF pulse is applied to the tissue, in (a) energy equivalent to the target energy is delivered to the tissue within a relatively short time, and in (b) energy equivalent to the target energy is delivered to the tissue over a relatively long time. Therefore, in (a), the RF pulse delivered to the tissue is terminated by the control unit at a relatively early point in time, resulting in a short pulse width (t 0a ), (b) the RF pulse delivered to the tissue is terminated by the control unit at a relatively late time, resulting in a long pulse width (t 0b ) has.
[0085] In this way, the reference RF pulse (P r ) is set to have energy greater than the target energy (E0), and the control unit (40) controls the reference RF pulse to be delivered to the tissue, but to end the RF pulse at a point when energy equivalent to the target energy is delivered. Accordingly, the pulse width of the RF pulse delivered to the tissue varies depending on the impedance characteristics of the tissue, but substantially the same amount of energy corresponding to the target energy (E0) is delivered to each tissue despite the difference in the impedance characteristics of the tissue.
[0086] However, in FIGS. 9 and 10, it is assumed that the impedance of the tissue remains constant while the RF pulse is applied, but it is also possible to determine the end point of the RF pulse by reflecting the change in the impedance of the tissue as the RF pulse is applied.
[0087] Figure 11 is a graph illustrating the current values measured by the monitoring unit and the amount of energy delivered to the tissue in another embodiment. As with Figure 9, the current values monitored over time while the RF pulse is applied are indicated by a dotted line, and the energy values delivered to the tissue calculated by this are indicated by a solid line.
[0088] When the impedance of the tissue changes while the RF pulse is applied, for example, when the impedance increases as the treatment progresses, the current value measured by the monitoring unit changes as i(t)=v0 / z(t), and the impedance change over time is calculated as z(t)=v0 / i(t). In this case, the energy E(t) applied to the tissue while the RF pulse is delivered is increases over time. And, the control unit controls the RF generator so that the RF pulse ends at the point in time (t0) when energy corresponding to the target energy is transferred, and the point in time (t0) when the RF pulse ends is (E0: target energy, i: current value, z: tissue impedance).
[0089] In this way, when the impedance of the tissue changes while a single RF pulse is applied, it is possible to determine the end point of the RF pulse by reflecting this change. However, the present invention is not limited thereto, and when it is determined that there is no significant difference in the change in the impedance of the tissue while the RF pulse is applied, as illustrated in Fig. 9, the end point of the RF pulse can be determined based on the current value measured once by the monitoring unit, and the pulse width of the RF pulse can be determined and controlled.
[0090] Meanwhile, as described above, the treatment device according to the present embodiment includes a setting unit (70), and the user sets treatment parameters through the setting unit (70) prior to performing treatment. At this time, the set treatment parameters may include a target energy value (E0) to be delivered to the tissue by each RF pulse. The setting unit may provide an option to select a target energy value delivered by a single RF pulse, or may provide an option to select a target energy value delivered as a whole by a plurality of RF pulses sequentially irradiated by a shot motion.
[0091] FIG. 12 is a graph illustrating an example of RF pulses continuously irradiated through the treatment device of FIG. 1. As an example, a treatment mode selected by a user through a setting unit continuously irradiates five pulses with a single shot operation. In addition, the user selects the target energy of the RF pulse, i.e., the amount of energy to be delivered to the tissue, through the setting unit. The setting unit is configured to set the energy value to be delivered to the tissue by a plurality of RF pulses, but this is only an example, and it is also possible to configure it to set the energy value delivered to the tissue by a single RF pulse.
[0092] Fig. 12 shows a case where the user selects 40J as the target energy, and the target energy (E0) of each RF pulse is determined as 8J. Once the target energy of each RF pulse is determined, the control unit (40) provides a reference RF pulse (P) corresponding to the target energy to each RF pulse. r ) is controlled to generate a reference RF pulse (P). As described above, the reference RF pulse (P r ) is determined to be a value in the range of 1.2 to 3 times the target energy of each set RF pulse, and as an example, the reference RF pulse of the present embodiment can be configured to apply energy of 12 J corresponding to 1.5 times the target energy.
[0093] Once the energy of the reference RF pulse is set, the parameters of the reference RF pulse, i.e., the reference power and the reference pulse width (t r ) is determined. The RF generator generates five reference RF pulses (P) having determined parameters, as shown in Fig. 12. r1 Inland P r5 ) are sequentially generated. At this time, the control unit monitors the energy delivered to the tissue by each RF pulse in real time and controls the RF pulse to be terminated at the point where energy corresponding to the target energy (E0) is delivered. Therefore, the termination point of the RF pulse varies depending on the energy absorption efficiency of the tissue.
[0094] Specifically, as shown in Fig. 12, five reference RF pulses (P r1 Inland P r5 ) are sequentially applied, each RF pulse ends before reaching the reference pulse width, but the end point of each RF pulse can be longer as the pulse width of the RF pulse is applied later (t 01 <t 02 <t 03 <t 04 <t 05 ). And, the efficiency of energy transfer to the tissue by each RF pulse (i.e., the efficiency of energy absorption by the tissue) may gradually decrease. As described above, the efficiency of energy transfer to the tissue is due to the impedance characteristics of the tissue. In this case, it can be interpreted that as RF pulses are repeatedly applied, the temperature of the tissue rises, the impedance increases, and as the impedance gradually increases, the energy transfer efficiency decreases. Nevertheless, by monitoring the energy transferred to the tissue by the RF pulse in real time while one RF pulse is transferred to the tissue and individually controlling the end point of each RF pulse, it is possible to control to transfer the same energy to the tissue as the set target energy.
[0095] In explaining Fig. 12, it was explained that the end point of each pulse is controlled according to real-time energy monitoring feedback when applying multiple RF pulses to tissues at the same location. However, even in cases where the location of the tissue is changed and each RF pulse is applied, or when applying RF pulses to different patients, since the amount of energy delivered to each tissue is directly monitored and the pulse end point is controlled, it is possible to control so that the same target energy is delivered by the RF pulse despite the difference in impedance of each tissue.
[0096] Hereinafter, with reference to FIGS. 13 and 14, a control method of a treatment device according to the present embodiment will be described in detail. However, in explaining the control method of the treatment device, the contents already explained through FIGS. 1 to 12 will be replaced with the preceding description.
[0097] Fig. 13 is a flowchart illustrating a control method of the treatment device of the present embodiment. Before proceeding with treatment, the user sets the treatment mode through the setting unit (70). Through this step, the user sets the treatment mode by considering the patient's characteristics, treatment location, treatment lesion, etc. (S10). The step of setting the treatment mode sets various parameters used for treatment, and specifically, the target energy value actually delivered to the tissue by the RF pulse can also be set in this step. As described above, the target energy setting can set the energy value delivered to the tissue by a single RF pulse as the target energy, and in the case of a treatment mode in which multiple RF pulses are continuously irradiated, the total energy value delivered to the tissue by the multiple RF pulses can also be set as the target energy.
[0098] Once the treatment mode is set, the user installs a return unit (30) on the patient's body to perform the treatment (S20). The return unit (30) is installed so as to contact the patient's skin at a location opposite the patient's treatment area. This return unit (30) forms an RF circuit that passes through the patient's body together with the handpiece electrode when the handpiece's monopolar electrode contacts the treatment area during treatment.
[0099] Once the return unit (30) is installed, the user proceeds to a step of treating the patient's treatment area using the handpiece (20) (S30). During the treatment step, the user applies RF pulses while contacting the handpiece (20) to the patient's treatment location, thereby delivering RF energy to the tissue, thereby treating the patient. Fig. 14 is a flowchart illustrating the treatment step of Fig. 13 in more detail. Hereinafter, the treatment step will be described in more detail with reference to Fig. 14.
[0100] As described above, the treatment step includes a step of applying an RF pulse (S31). In this step, the control unit (40) operates the RF generator (50) to generate an RF pulse corresponding to the set treatment mode. At this time, the generated RF pulse is a reference RF pulse and has a reference output and a reference RF pulse width. As described above, the reference RF pulse is formed to have energy in the range of 1.2 to 3 times the set target energy (energy value to be delivered to the tissue by one RF pulse). The reference RF pulse is applied to the tissue through an RF circuit formed by the electrode unit (141) and the return unit (30).
[0101] While a single RF pulse is applied, the monitoring unit (35) monitors the amount of energy actually transferred to the tissue (S32). As described above, even when the same RF pulse is applied to the tissue, the amount of energy transferred to and absorbed by the tissue varies depending on the impedance of the tissue. Therefore, the monitoring unit (35) measures the parameters of the RF circuit to monitor the amount actually transferred to the tissue. Specifically, the monitoring unit (35) measures the current value flowing through the return unit (30) and, based on this, calculates in real time the amount of energy transferred to the tissue while a single RF pulse is applied.
[0102] Then, the monitoring unit (35) compares the energy value delivered to the tissue with the target energy (S33). If the amount of energy delivered to the tissue is less than the set target energy, the control unit (40) continuously delivers the corresponding reference RF pulse and continuously monitors. However, if it is determined that the amount of energy delivered to the tissue has reached the target energy, the control unit (40) controls the RF pulse to be terminated even though it is before the corresponding reference RF pulse reaches the reference pulse width (S34).
[0103] The steps described in Figure 14 are steps from the start to the end of a single RF pulse. Therefore, when treatment is performed by applying multiple RF pulses, the treatment is performed by repeating the steps of Figure 14 for each RF pulse.
[0104] In this case, the energy delivered to the tissue by each RF pulse is monitored in real time and the pulse termination point is controlled. Therefore, even when the efficiency of energy delivery varies depending on the characteristics of the tissue, the pulse width of each RF pulse can be controlled differently to deliver the same energy to the tissue, enabling uniform treatment.
[0105] While one embodiment of the present invention has been described in detail above, the present invention is not limited to the above-described embodiment. It should be apparent that those skilled in the art will be able to implement the present invention in various ways, including modifications and variations, without departing from the scope of the technical features defined in the appended claims.
Claims
1. RF generator; An electrode unit that contacts the patient's skin and applies RF pulses generated from the RF generator; A return portion that contacts the patient's skin at a position opposite to the electrode portion and through which the RF pulse applied from the electrode portion is returned; and A treatment device using RF, comprising a control unit that controls the parameters of the RF pulse so that a preset amount of energy is delivered to the tissue by each RF pulse.
2. In paragraph 1, The above control unit is a treatment device using RF that controls the pulse width of the RF pulse so that a preset amount of energy is transmitted to the tissue by each RF pulse.
3. In paragraph 1, A treatment device using RF, further comprising a monitoring unit for monitoring the amount of energy delivered to the tissue by the RF pulse.
4. In paragraph 3, A treatment device using RF, wherein the monitoring unit measures the current value passing through the electrode unit or the return unit, and determines the amount of energy delivered to the tissue by the RF pulse based on the measured current value.
5. In paragraph 3, A treatment device using RF, wherein the monitoring unit measures the current value returned from the return unit and determines the amount of energy delivered to the tissue by the RF pulse based on the measured current value.
6. In paragraph 1, It further includes a setting section for setting the target energy to be delivered to the tissue with the RF pulse, A treatment device using RF in which the RF generator generates an RF pulse having energy exceeding the target energy, and the control unit controls the RF pulse to be terminated when energy corresponding to the target energy is delivered to the tissue by the RF pulse.
7. In paragraph 6, The above RF generator is a treatment device using RF that generates an RF pulse having an energy in the range of 1.2 to 3 times the target energy.
8. In paragraph 2, A treatment device using RF, characterized in that the RF pulses applied to the above tissue each deliver the same energy to the tissue, but the RF pulse width is variable by the control unit.
9. In paragraph 2, A treatment device using RF, characterized in that the control unit individually controls the end point of each RF pulse.
10. In paragraph 3, The above monitoring unit measures the current value returned from the return unit, and the control unit E0 = i 2 A treatment device using RF that controls the RF pulse to end at t0 satisfying ·z·t0 (E0: target energy, i: current value, z: tissue impedance).
11. In paragraph 3, The above monitoring unit measures the current value returned from the return unit, and the control unit A treatment device using RF that controls the RF pulse to be terminated at t0 satisfying (E0: target energy, i: current value, z: tissue impedance).
12. A step of transmitting RF pulses generated from an RF generator to tissue using electrodes and a return unit each placed in contact with the patient's skin; A step of monitoring the energy delivered to the tissue by the RF pulse; and A method for controlling a treatment device using RF, comprising: a step of a control unit adjusting parameters of the RF pulse so that the energy delivered to the tissue by each RF pulse is constant; 13. In paragraph 12, A method for controlling a treatment device using RF, wherein the step of controlling the parameters of the RF pulse controls the end point of the RF pulse.
14. In paragraph 12, A method for controlling a treatment device using RF, wherein the monitoring step measures a current value returned from the return unit and determines energy delivered to the tissue by the RF pulse based on the measured current value.
15. In paragraph 12, A control method for a treatment device using RF, further comprising a step of setting a target energy value to be delivered to a tissue by each of the above RF pulses.
16. In paragraph 15, A control method for a treatment device using RF, characterized in that the RF pulse generated from the RF generator has energy exceeding the set target energy, and when energy corresponding to the target energy is transmitted to the tissue by the RF pulse, the control unit controls the RF pulse to be terminated.
17. In paragraph 12, A control method for a treatment device using RF, wherein the RF pulse applied to the tissue transmits energy of a constant size to the tissue, but each pulse width is variable.
18. In paragraph 12, The above monitoring step measures the current value returned from the return section, The step of adjusting the parameters of the above RF pulse is E0= i 2 A control method for a treatment device using RF, which controls the RF pulse to end at t0 satisfying ·z·t0 (E0: target energy, i: current value, z: tissue impedance).
19. In paragraph 12, The above monitoring step measures the current value returned from the return section, The step of adjusting the parameters of the above RF pulse is A control method for a treatment device using RF, which controls the RF pulse to end at t0 satisfying (E0: target energy, i: current value, z: tissue impedance). 20.RF generator; An electrode part that contacts the patient's skin and applies RF pulses generated from the RF generator; and A treatment device using RF, including a control unit that controls the pulse width of the RF pulse to be variable while each RF pulse transmits energy of a constant size to the tissue.
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