Sensitive skin adaptive monopolar radiofrequency output safety control method

Abstract

The present application belongs to the technical field of radio frequency energy control, and discloses a sensitive muscle adaptive monopolar radio frequency output safety control method, wherein a controller determines radio frequency output parameters and planned sub-pulse quantity according to action partition, planned radio frequency pulse number and sensitive muscle adaptive mode; before radio frequency pulse starts, whether to output the first radio frequency sub-pulse is determined according to surface temperature monitoring value, and the executed radio frequency pulse number is updated accordingly; during output, when the temperature reaches the upper limit of safety temperature, the subsequent radio frequency sub-pulse is stopped and refrigeration is performed, and the executed radio frequency pulse number does not back off; the output parameters are re-determined for the next radio frequency pulse, and the sub-pulse not executed by the previous radio frequency pulse is not used to increase the output parameters of the subsequent radio frequency pulse or the planned radio frequency pulse number, and the present application is used for partition output safety control of non-invasive monopolar loop radio frequency equipment.

Description

Technical Field

[0001] This invention belongs to the field of radio frequency energy control technology, specifically a method for safe control of unipolar radio frequency output adapted to sensitive skin. Background Technology

[0002] Monopolar RF devices with loops form an RF loop through a working electrode and a loop electrode to apply RF energy to the target area. Existing devices can usually set the RF output power, pulse duration, and cooling intensity according to different target areas and tolerance conditions, and control the RF output process in conjunction with surface temperature monitoring. During zoned operation, the number of RF pulses can also be preset for different target areas, and the corresponding number of pulses executed can be recorded.

[0003] When multiple RF pulse outputs need to be completed in the same functional zone, the surface temperature may reach the limit condition before the current RF pulse is actually output, or it may reach the limit condition after some RF sub-pulses have been output. Although the existing temperature control can limit or stop the current RF output when the temperature is abnormal, there are inconsistencies in the correspondence between the RF output status, the zone output status and the subsequent RF pulse parameters. These inconsistencies include whether the current RF pulse should be included in the number of pulses executed under different triggering stages, and how RF sub-pulses that have not been executed after premature termination should participate in the subsequent output control.

[0004] When the current RF pulse that has already generated actual RF output ends prematurely due to temperature conditions, if the number of pulses already executed cannot accurately reflect the state of the RF output, or if the RF sub-pulses that have not yet been executed continue to participate in the determination of the number of pulses or output parameters of the next RF pulse, it may lead to a discrepancy between the remaining number of RF pulses and the actual RF output situation. This will also weaken the output limitation of the current RF pulse caused by temperature conditions in subsequent RF pulses. For sensitive areas that use lower RF output power and longer pulse duration for multiple partitioned outputs, the above-mentioned inconsistency in the correspondence between states will further affect the temperature safety control and output quantity management during continuous RF output. Summary of the Invention

[0005] This invention aims to address the problem that existing monopolar radio frequency devices, when outputting multiple radio frequency pulses to sensitive areas, lack differentiated handling between two states: the radio frequency pulse is blocked before it starts due to temperature conditions, and the radio frequency pulse is prematurely stopped after it has started outputting due to temperature conditions. This results in the unexecuted portion of the radio frequency pulse that has already partially outputting radio frequency pulses potentially continuing to affect the number of subsequent radio frequency outputs or output parameters after it has prematurely ended. The invention provides a safe control method for monopolar radio frequency output adapted to sensitive skin.

[0006] To achieve the above objectives, the method of the present invention is executed by a controller of a non-invasive monopolar radio frequency device, the non-invasive monopolar radio frequency device including an input unit, a controller, a radio frequency generation unit, a working electrode, a loop electrode, a temperature monitoring unit, and a cooling unit, wherein a radio frequency loop is formed between the working electrode and the loop electrode.

[0007] The controller receives the action zone, the planned number of radio frequency pulses corresponding to the action zone, and the sensitive skin adaptation mode through the input unit, and obtains the number of radio frequency pulses that have been recorded for the action zone. The sensitive skin adaptation mode corresponds to a pre-set combination of radio frequency output parameters, which includes radio frequency output power, pulse duration, and cooling intensity. The controller determines the radio frequency output power, pulse duration, and cooling intensity of the current radio frequency pulse based on the current action zone and the sensitive skin adaptation mode, and determines the planned number of sub-pulses of the current radio frequency pulse based on the pulse duration and sub-pulse duration.

[0008] Before the current RF pulse is started, the temperature monitoring unit acquires the surface temperature monitoring value of the working electrode's corresponding operating range. When the surface temperature monitoring value reaches the upper limit of the safe temperature, the controller does not send the RF sub-pulse trigger control signal to the RF generation unit, keeps the number of RF pulses executed in the current operating zone unchanged, and controls the cooling unit to work according to the cooling intensity in the current RF output parameter combination. When the surface temperature monitoring value is lower than the upper limit of the safe temperature, the controller sends the first RF sub-pulse trigger control signal to the RF generation unit. After the first RF sub-pulse is output, the number of RF pulses executed in the current operating zone is increased by one.

[0009] During the current RF pulse output, the controller records the number of executed sub-pulses and obtains the surface temperature monitoring value provided by the temperature monitoring unit. When the number of executed sub-pulses reaches the planned number of sub-pulses, the current RF pulse ends. When the number of executed sub-pulses is less than the planned number of sub-pulses and the surface temperature monitoring value reaches the upper limit of the safe temperature, the controller stops sending the trigger control signal corresponding to the RF sub-pulses that have not yet been executed in the current RF pulse to the RF generation unit, ends the current RF pulse, and controls the cooling unit to work according to the cooling intensity in the current RF output parameter combination. If the current RF pulse has completed the first RF sub-pulse output, the number of executed RF pulses that have been added to the current action zone will not be reduced due to the early end of the current RF pulse.

[0010] Before the subsequent RF pulse is started, the controller determines the remaining number of RF pulses based on the planned number of RF pulses for the corresponding action zone and the number of RF pulses already executed. When the remaining number of RF pulses is greater than zero, the controller re-determines the RF output power, pulse duration, and cooling intensity based on the action zone and sensitive skin adaptation mode corresponding to the subsequent RF pulse, and determines the planned number of sub-pulses for the subsequent RF pulse based on the re-determined pulse duration and sub-pulse duration. The number of RF sub-pulses that were not executed in the previous RF pulse because the surface temperature monitoring value reached the upper limit of the safe temperature is not included in the planned number of sub-pulses for the subsequent RF pulse, and is not used as a basis for increasing the RF output power or extending the pulse duration of the subsequent RF pulse, nor does it increase the planned number of RF pulses for the corresponding action zone.

[0011] The non-invasive monopolar closed-loop radio frequency device has a pre-stored partition parameter table. The partition parameter table records the correspondence between the action partition, the reference energy density range, and the combination of radio frequency output parameters. Different action partitions correspond to the corresponding reference energy density ranges and radio frequency output parameter combinations. The reference energy density ranges include 10-20 joules per square centimeter, 15-25 joules per square centimeter, 20-25 joules per square centimeter, and 20-30 joules per square centimeter. Different action partitions correspond to one of the reference energy density ranges.

[0012] The operating area is divided into sensitive and non-sensitive areas based on sensitivity attributes. For the same pulse duration, the RF output power in the RF output parameter combination corresponding to the sensitive area is lower than that in the RF output parameter combination corresponding to the non-sensitive area. The same operating area corresponds to multiple sets of RF output parameter combinations with different pulse durations. Among them, the RF output power corresponding to the longer pulse duration is lower than that corresponding to the shorter pulse duration, so that the RF output power and pulse duration are matched according to the predetermined parameter combination, without generating new RF output parameters temporarily during the RF output process.

[0013] The sub-pulse duration is 100 milliseconds. The pulse duration includes 0.7 seconds, 1.0 seconds, 1.3 seconds and 1.5 seconds. When the pulse duration is 1.5 seconds, the planned number of sub-pulses for the current radio frequency pulse is 15, and the duration of each radio frequency sub-pulse is 100 milliseconds.

[0014] The temperature monitoring unit acquires surface temperature values ​​from multiple monitoring points within the working electrode's effective range. At the same sampling moment, the maximum value among these surface temperature values ​​is determined as the surface temperature monitoring value. This surface temperature monitoring value is used for temperature determination before and during the RF pulse output process. The upper limit of the safe temperature is set to no higher than 45 degrees Celsius. Once the surface temperature monitoring value reaches the upper limit of the safe temperature, the controller controls the cooling unit to operate according to the cooling intensity in the current RF output parameter combination and reacquires the surface temperature monitoring value. If the reacquired surface temperature monitoring value is lower than the upper limit of the safe temperature, the controller is allowed to respond to a new RF pulse output command.

[0015] Different functional zones establish corresponding records for the planned number of radio frequency pulses and the number of radio frequency pulses already executed. When switching from the current functional zone to another functional zone, the controller saves the number of radio frequency pulses already executed for the current functional zone and reads the planned number of radio frequency pulses and the number of radio frequency pulses already executed for the functional zone after the switch. When selecting a functional zone that has already performed radio frequency output again, the controller reads the number of radio frequency pulses already executed for that functional zone and determines the remaining number of radio frequency pulses based on the planned number of radio frequency pulses and the number of radio frequency pulses already executed for that functional zone. When the remaining number of radio frequency pulses is zero, the controller does not send a new radio frequency pulse trigger control signal for that functional zone to the radio frequency generation unit.

[0016] Compared with the prior art, the present invention determines the update status of the number of executed radio frequency pulses before the radio frequency pulse is started and after the radio frequency pulse has started to output. This ensures that radio frequency pulses that are blocked by temperature conditions before generating radio frequency output do not occupy the planned number of radio frequency pulses. Meanwhile, radio frequency pulses that have already output the first radio frequency sub-pulse retain the increased number of executed radio frequency pulses even if they end prematurely due to temperature conditions. This ensures that the remaining number of radio frequency pulses corresponds to the actual radio frequency output status, avoiding the need to determine the subsequent output number solely based on whether the radio frequency pulse has completely ended.

[0017] This invention stops the trigger control signal corresponding to the unexecuted RF sub-pulse when the current RF pulse ends prematurely due to temperature conditions, and re-determines the RF output parameters and the number of planned sub-pulses according to the corresponding action zone and sensitive muscle adaptation mode when the subsequent RF pulse starts. This prevents the RF sub-pulses that were not executed in the previous RF pulse from being transferred to the subsequent RF pulse, and also prevents the compensation output from being re-formed by increasing the RF output power, extending the pulse duration, or increasing the number of planned RF pulses. As a result, the output limitation caused by the temperature safety stop continues to act on the subsequent RF output process.

[0018] This invention also saves the planned number of radio frequency pulses and the number of radio frequency pulses executed for each functional zone separately, and uses the remaining number of radio frequency pulses as the control condition for the subsequent radio frequency output of the corresponding functional zone. This allows different functional zones to maintain their own independent radio frequency pulse count state when alternately outputting radio frequency. Furthermore, it combines the reference energy density range and radio frequency output parameter combination corresponding to different functional zones to perform zone control, so that the sensitive area completes the radio frequency output with its corresponding radio frequency output power, pulse duration and cooling intensity.

[0019] The beneficial effects of this invention are as follows: 1. This invention sets RF pulse count update conditions before the current RF pulse is started and after RF output has occurred. When the surface temperature monitoring value reaches the upper limit of the safe temperature and the first RF sub-pulse has not yet been output, the number of executed RF pulses remains unchanged. After the first RF sub-pulse has been output, the current RF pulse is counted in the number of executed RF pulses. This count is not rolled back even if the RF pulse ends prematurely due to the temperature reaching the upper limit of the safe temperature. This achieves the effect of making the RF pulse count state of the active zone correspond to the actual RF output state, avoiding the RF pulses that have already partially output RF pulses being re-counted in the subsequent output count due to incomplete execution. This allows the remaining RF pulse count to serve as an effective control basis for the qualification of subsequent RF outputs.

[0020] 2. This invention stops unexecuted RF sub-pulses based on surface temperature monitoring values ​​during the current RF pulse output process, and re-determines the RF output power, pulse duration, cooling intensity, and planned sub-pulse number based on the corresponding action zone and sensitive skin adaptation mode when establishing the next RF pulse. This ensures that the number of unexecuted RF sub-pulses from the previous RF pulse does not participate in the parameter increase of the subsequent RF pulse, thereby avoiding the formation of cross-RF pulse compensation output after temperature safety abort. It also prevents the formation of additional RF output by increasing the planned sub-pulse number of the subsequent RF pulse, increasing the RF output power, extending the pulse duration, or increasing the number of planned RF pulses, thus keeping temperature monitoring, RF abort, and subsequent output control continuous and consistent.

[0021] 3. This invention establishes planned RF pulse counts and executed RF pulse counts for different functional zones, and determines the reference energy density range and RF output parameter combination for each functional zone by combining the zone parameter table. When switching functional zones, the count status of the original functional zone is saved. When the functional zone is selected again, the remaining RF pulse count is determined based on the saved executed RF pulse counts. This achieves the effect of controlling the RF output parameters and RF pulse counts of different functional zones separately. At the same time, sensitive areas use their corresponding RF output power, pulse duration, and cooling intensity, reducing the mixing of parameters and count statuses between different functional zones during the alternating output of zones, and improving the consistency of RF output control of zones. Attached Figure Description

[0022] Figure 1 This is an overall flowchart of the safety control method for unipolar radio frequency output adapted to sensitive skin according to the present invention; Figure 2 This is a block diagram of the control structure of the non-invasive single-pole closed-loop radio frequency device of the present invention; Figure 3 This is a flowchart illustrating the temperature safety control process before and during the output of the radio frequency pulse in this invention. Figure 4 This is a schematic diagram of the output timing of the radio frequency pulse and radio frequency sub-pulse of the present invention; Figure 5 This is a schematic diagram showing the correspondence between the functional zones, sensitive skin adaptation modes, and radio frequency output parameter combinations of the present invention. Figure 6 This is a schematic diagram of the radio frequency pulse state and counting state transition of the present invention; Figure 7 This is a schematic diagram illustrating the functional zone switching and independent recording of radio frequency pulse counts of the present invention. Detailed Implementation

[0023] 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 some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] This implementation uses a non-invasive monopolar radio frequency device for the face to alternately cover different functional zones, with each functional zone completing multiple radio frequency pulse outputs. When using lower radio frequency output power and longer pulse duration in sensitive areas, the current radio frequency pulse may be limited due to the surface temperature reaching the upper limit of the safe temperature before it has started or after a partial output of radio frequency sub-pulses. The controller establishes a correspondence between whether the radio frequency pulse has occurred and the actual radio frequency output status of the functional zone, and independently establishes the output parameters of the next radio frequency pulse after the current radio frequency pulse ends prematurely.

[0025] like Figures 1 to 7 As shown, this embodiment of the invention provides a safety control method for unipolar radio frequency output adapted to sensitive skin; I. Equipment Composition and Control Relationships The non-invasive monopolar loop-connected radio frequency device used in this embodiment includes an input unit, a controller, a radio frequency generation unit, a working electrode, a loop electrode, a temperature monitoring unit, and a cooling unit. A radio frequency loop is formed between the working electrode and the loop electrode. The radio frequency generation unit provides radio frequency output to the working electrode according to the trigger control signal output by the controller. The cooling unit cools the corresponding range of the working electrode according to the cooling control parameters output by the controller.

[0026] The controller includes a processor and a memory. The memory stores at least the partition parameter table, the sub-pulse configuration relationship, and the radio frequency pulse count status corresponding to each functional partition. The processor reads the corresponding radio frequency output parameters based on the functional partition, the planned radio frequency pulse count, and the sensitive skin adaptation mode received by the input unit, and controls the radio frequency generation unit and the cooling unit in conjunction with the surface temperature monitoring value provided by the temperature monitoring unit.

[0027] In one device implementation, the operating frequency of the radio frequency generation unit is 6.78 MHz and the maximum output power is 175 watts. The above parameters represent the device's rated output conditions for the radio frequency generation unit. The radio frequency output power used for the current radio frequency pulse is determined by the combination of radio frequency output parameters corresponding to the current action zone and the sensitive skin adaptation mode.

[0028] The action zone is selected by the operator through the input unit according to the pre-divided facial operation area or operation grid. The controller uses the action zone as an index for the zone parameters and the radio frequency pulse count status, and determines the current action zone without relying on image recognition, spatial coordinate tracking or historical action point automatic positioning.

[0029] The sensitive skin adaptation mode is a pre-set radio frequency output control mode for the device. It is used to select the radio frequency output power, pulse duration and cooling intensity in the combination of radio frequency output parameters corresponding to the current action zone. The sensitive skin adaptation mode is a device-side output parameter selection condition and is not used to make disease diagnoses or judge the skin health status.

[0030] II. Partition Parameter Table and RF Output Parameter Combinations The partition parameter table uses the functional partition as an index to record the reference energy density range corresponding to the functional partition and one or more combinations of RF output parameters. Each combination of RF output parameters includes at least RF output power, pulse duration and cooling intensity. When the same functional partition has multiple combinations of RF output parameters, each set of parameters corresponds to the preset output conditions.

[0031] The reference energy density is the single-shot energy reference value corresponding to a unit area of ​​action. It is stored as a preset parameter for the action zone in the partition parameter table and associated with the corresponding RF output parameter combination for that action zone. The reference energy density range includes 10–20 joules per square centimeter, 15–25 joules per square centimeter, 20–25 joules per square centimeter, and 20–30 joules per square centimeter. Reference zones one and three correspond to 15–25 joules per square centimeter, reference zone two corresponds to 20–30 joules per square centimeter, reference zones four and six correspond to 10–20 joules per square centimeter, and reference zone five corresponds to 20–25 joules per square centimeter.

[0032] When the device is running, the controller directly reads the established combination of radio frequency output parameters based on the current functional zone and sensitive skin adaptation mode, without using the number of radio frequency sub-pulses that have not yet been executed in the current radio frequency pulse as the basis for increasing the radio frequency output power or extending the pulse duration.

[0033] For the same pulse duration, the RF output power corresponding to the sensitive area is lower than that corresponding to the non-sensitive area. As an example of parameter configuration, when the pulse duration is 1.0 seconds, the non-sensitive area uses the 4.5 power level and the sensitive area uses the 4.0 power level; when the pulse duration is 0.7 seconds, the non-sensitive area uses the 7 power level and the sensitive area uses the 5.5-6 power level; when the pulse duration is 1.3 seconds, the non-sensitive area uses the 3 power level and the sensitive area uses the 2.5 power level.

[0034] Multiple sets of RF output parameter combinations with different pulse durations can be configured in the same functional zone. For multiple pre-established RF output parameter combinations, a longer pulse duration corresponds to a lower RF output power, and a shorter pulse duration corresponds to a higher RF output power. The RF output power and pulse duration are read together by the controller as associated parameters in the same RF output parameter combination.

[0035] The cooling intensity is a preset control parameter of the cooling unit, which can be represented by the cooling level inside the device. When the controller reads the combination of RF output parameters, it simultaneously reads the corresponding cooling intensity and sends the control parameters corresponding to the cooling intensity to the cooling unit. Each cooling level corresponds to a set of pre-stored cooling operating parameters, and the operator is not required to recalculate the cooling parameters during the RF output process.

[0036] Table 1 Examples of clearly defined parameters used in this implementation method

[0037] III. Radio frequency pulse, radio frequency sub-pulse, and current radio frequency pulse record An RF pulse is composed of a preset number of RF sub-pulses in sequence. The duration of each sub-pulse is 100 milliseconds. The pulse duration of the RF pulse can be selected from 0.7 seconds, 1.0 seconds, 1.3 seconds and 1.5 seconds. When the pulse duration is 1.5 seconds, the planned number of sub-pulses is 15, and the duration of each RF sub-pulse is 100 milliseconds.

[0038] The memory stores the sub-pulse configuration relationship, which uses pulse duration and sub-pulse duration as configuration items and records the planned number of sub-pulses corresponding to them. After the controller reads the pulse duration and sub-pulse duration of the current radio frequency pulse, it obtains the planned number of sub-pulses from the sub-pulse configuration relationship. For pulse durations of 0.7 seconds, 1.0 seconds, and 1.3 seconds, this embodiment does not directly estimate the fixed planned number of sub-pulses by dividing the pulse duration by 100 milliseconds, but uses the corresponding configuration value pre-stored by the device.

[0039] The controller establishes a current RF pulse record for each RF pulse to be executed. The current RF pulse record includes at least the action zone, RF output power, pulse duration, cooling intensity, number of planned sub-pulses, number of executed sub-pulses, and current RF pulse status. When establishing the record, the number of executed sub-pulses is set to zero, and the current RF pulse status is set to inactive.

[0040] The current RF pulse status includes inactive, output, and terminated states. It is inactive when the first RF sub-pulse trigger control signal has not been sent; it is updated to output state after the first RF sub-pulse is completed; it is updated to terminated state when all planned sub-pulses have been executed or when the subsequent output of the current RF pulse stops due to safe temperature conditions.

[0041] IV. Radio Frequency Pulse Count Status of the Functional Zone The controller establishes a planned number of radio frequency (RF) pulses and an executed number of RF pulses for different functional zones. The planned number of RF pulses represents the total number of RF pulses allowed to be generated in the current functional zone during this zone's output process. This number is input by the operator through the input unit or selected from pre-set zone operation parameters. The executed number of RF pulses records the number of RF pulses that have actually been output by the functional zone for the first RF sub-pulse.

[0042] When establishing the radio frequency pulse count status for a certain action zone for the first time, the number of radio frequency pulses already executed is set to zero. The controller uses the difference between the planned number of radio frequency pulses and the number of radio frequency pulses already executed as the remaining number of radio frequency pulses, and re-determines the remaining number of radio frequency pulses before establishing a new radio frequency pulse.

[0043] The planned number of radio frequency pulses remains at the set value during the current partition's output process and will not automatically increase due to the early termination of a certain radio frequency pulse; the number of executed radio frequency pulses is updated according to whether the radio frequency pulse has actually output the first radio frequency sub-pulse, and is not calculated according to the proportion of radio frequency sub-pulses completed by the current radio frequency pulse.

[0044] The planned and executed RF pulse counts for different action zones are stored independently. When switching action zones, the controller saves the count status of the original action zone and reads the count status of the action zone after the switch; when the original action zone is selected again, the previously saved executed RF pulse counts for that action zone are used.

[0045] V. Surface Temperature Monitoring Values ​​and Safe Temperature Conditions The temperature monitoring unit establishes a data connection with the controller to obtain surface temperature detection data within the corresponding range of the working electrode. In the implementation of multi-point temperature monitoring, the temperature monitoring unit obtains surface temperature detection values ​​of multiple temperature monitoring points within the corresponding range of the working electrode. The multiple temperature monitoring points can be formed by multiple temperature measurement positions in the thermal imaging temperature measurement component, or by multiple temperature detection points arranged in the corresponding range of action.

[0046] After obtaining multiple surface temperature detection values ​​at the same sampling time, the controller compares the multiple surface temperature detection values ​​and determines the surface temperature detection value with the largest value as the surface temperature monitoring value at that sampling time. Subsequent safety temperature judgments all use the most recently updated surface temperature monitoring value.

[0047] The upper limit of safe temperature is pre-stored in the controller and the value is no higher than 45 degrees Celsius. In one specific embodiment, the upper limit of safe temperature is set to 45 degrees Celsius. After the current radio frequency pulse is established, the same determined upper limit of safe temperature is used for the judgment before startup and the judgment during output.

[0048] Before the current RF pulse is started, the controller obtains the surface temperature monitoring value and receives the updated surface temperature monitoring data according to the predetermined sampling sequence of the temperature monitoring unit. Before preparing to send the trigger control signal for the next RF sub-pulse to be executed to the RF generation unit, the controller reads the most recently updated surface temperature monitoring value and determines whether to allow the sending of the trigger control signal. This process does not require a fixed temperature sampling period to be defined in advance; it only needs to ensure that the new temperature judgment result is available for the controller to read before the next RF sub-pulse to be executed is triggered.

[0049] VI. Judgment before the current radio frequency pulse is initiated When the controller receives an RF pulse output command for the current action zone, it first reads the planned number of RF pulses and the number of RF pulses already executed for that action zone, and determines the remaining number of RF pulses. When the remaining number of RF pulses is zero, the controller does not establish a new current RF pulse record, nor does it send a new RF sub-pulse trigger control signal to the RF generation unit.

[0050] When the number of remaining radio frequency pulses is greater than zero, the controller reads the combination of radio frequency output parameters according to the current application zone and sensitive skin adaptation mode, establishes the current radio frequency pulse record, and obtains the current surface temperature monitoring value.

[0051] When the current surface temperature monitoring value reaches the upper limit of the safe temperature, the controller keeps the current radio frequency pulse in the inactive state and does not send the trigger control signal of the first radio frequency sub-pulse. The number of radio frequency pulses executed in the current active zone remains unchanged. At the same time, the controller controls the operation of the cooling unit according to the cooling intensity recorded in the current radio frequency pulse.

[0052] During the cooling process, the temperature monitoring unit continues to provide the controller with updated surface temperature detection data. Once the newly acquired surface temperature monitoring value is lower than the upper limit of the safe temperature, the controller releases the output restriction formed by this temperature judgment. After the restriction is released, it still needs to receive the radio frequency pulse output command and re-execute the pre-start judgment. The temperature drop itself does not directly trigger the radio frequency output.

[0053] VII. First RF sub-pulse output and update of the number of RF pulses executed When the remaining number of RF pulses is greater than zero and the surface temperature monitoring value obtained before startup is lower than the upper limit of the safe temperature, the controller sends the trigger control signal of the first RF sub-pulse to the RF generation unit, and the RF generation unit completes the output of the first RF sub-pulse according to the RF output power in the current RF pulse record.

[0054] After the output period corresponding to the first radio frequency sub-pulse ends, the controller increments the number of executed sub-pulses of the current radio frequency pulse by one, updates the current radio frequency pulse state from the inactive state to the output state, and increments the number of executed radio frequency pulses of the current active zone by one.

[0055] Therefore, radio frequency pulses that are not started before the first radio frequency sub-pulse is output because the surface temperature monitoring value reaches the upper limit of the safe temperature do not increase the number of radio frequency pulses already executed; radio frequency pulses that have completed the first radio frequency sub-pulse output occupy one planned radio frequency pulse count of the current action zone, and whether all planned sub-pulses are completed thereafter does not change the count result.

[0056] 8. Continuous output and safe interruption during RF pulse output When the current RF pulse enters the output state, if the number of executed sub-pulses is less than the planned number of sub-pulses, the controller reads the most recently updated surface temperature monitoring value before sending the trigger control signal for the next RF sub-pulse to be executed.

[0057] When the surface temperature monitoring value is lower than the upper limit of the safe temperature, the controller sends the trigger control signal for the next radio frequency sub-pulse. After the output period of the corresponding radio frequency sub-pulse ends, the number of executed sub-pulses is increased by one. When the number of executed sub-pulses reaches the planned number of sub-pulses, the current radio frequency pulse status is updated to the end status, and no more radio frequency sub-pulse trigger control signals belonging to the current radio frequency pulse are sent.

[0058] When the number of executed sub-pulses is less than the planned number of sub-pulses and the surface temperature monitoring value reaches the upper limit of the safe temperature, the controller will no longer send the trigger control signal for subsequent radio frequency sub-pulses in the current radio frequency pulse, update the current radio frequency pulse status to the end state, and control the cooling unit to work according to the cooling intensity recorded in the current radio frequency pulse.

[0059] If the current radio frequency pulse ends prematurely due to safe temperature conditions, the number of executed radio frequency pulses remains unchanged and will not be rolled back even if the actual number of radio frequency sub-pulses completed by the current radio frequency pulse is less than the planned number of sub-pulses.

[0060] 9. Unprocessed radio frequency sub-pulse after early termination When the current radio frequency pulse ends prematurely due to safe temperature conditions, the controller terminates the sub-pulse sequence corresponding to the current radio frequency pulse and no longer generates or sends trigger control signals for radio frequency sub-pulses that have not yet been executed. The memory can retain the number of planned sub-pulses and the number of executed sub-pulses of the current radio frequency pulse as an operation record, but the operation record is not used as the parameter increment for subsequent radio frequency pulses.

[0061] When establishing the next RF pulse, the controller creates a new independent RF pulse record, rereads the RF output power, pulse duration, and cooling intensity according to the corresponding action zone and sensitive skin adaptation mode of the RF pulse, and re-determines the planned number of sub-pulses based on the pulse duration and sub-pulse configuration relationship.

[0062] The parameter determination process for the next RF pulse does not read the number of unexecuted RF sub-pulses in the previous RF pulse as compensation input. The number of unexecuted RF sub-pulses in the previous RF pulse does not increase the planned number of sub-pulses for the next RF pulse, does not increase the RF output power of the next RF pulse, does not extend the pulse duration of the next RF pulse, and does not increase the planned number of RF pulses for the corresponding action zone.

[0063] 10. Subsequent RF pulse output qualification and function zone switching After the current radio frequency pulse ends, the controller rereads the planned number of radio frequency pulses and the number of radio frequency pulses executed for the current active zone, and determines the remaining number of radio frequency pulses. When the remaining number of radio frequency pulses is greater than zero, after receiving the radio frequency pulse output command for the active zone again, the controller establishes a new radio frequency pulse record and re-executes the temperature judgment before startup.

[0064] When the remaining number of radio frequency pulses is zero, the controller sets the function zone to the radio frequency pulse count completed state, blocks new radio frequency pulse trigger requests for the function zone, and does not send new radio frequency pulse trigger control signals to the radio frequency generation unit.

[0065] When switching from the current action zone to another action zone, the controller saves the number of RF pulses executed in the current action zone, and reads the planned number of RF pulses and the number of RF pulses executed in the action zone after the switch. When reselecting an action zone that has already executed RF output, the remaining number of RF pulses is determined based on the number of RF pulses executed saved in that action zone.

[0066] The radio frequency pulse counts of each function zone are independent of each other. If the radio frequency pulse count of a certain function zone ends prematurely due to safe temperature conditions, the planned radio frequency pulse counts and executed radio frequency pulse counts already saved in other function zones will not be modified.

[0067] XI. Example of Control State To illustrate the correspondence between temperature judgment, RF output status, and the number of RF pulses in the affected zone, three control states are given below. This table explains the control states and subsequent processing relationships under different triggering conditions.

[0068] Table 2 Examples of RF pulse control states

[0069] XII. Complete Implementation Process of Zoned Multi-RF Pulse Output During a single multi-radio frequency pulse output process, the operator selects the current action zone, the planned number of radio frequency pulses for that action zone, and the sensitive skin adaptation mode through the input unit. The controller reads the number of radio frequency pulses already executed saved for the current action zone and determines the remaining number of radio frequency pulses.

[0070] When the remaining number of RF pulses is greater than zero, the controller reads the RF output power, pulse duration and cooling intensity from the partition parameter table, obtains the planned number of sub-pulses based on the pulse duration and sub-pulse configuration relationship, establishes the current RF pulse record, and obtains the surface temperature monitoring value before startup.

[0071] When the surface temperature monitoring value reaches the upper limit of the safe temperature, the first radio frequency sub-pulse is not output, the number of radio frequency pulses executed in the current active zone remains unchanged, and cooling is performed; when the surface temperature monitoring value is lower than the upper limit of the safe temperature, the first radio frequency sub-pulse is output, and the number of executed radio frequency pulses is increased after the output period corresponding to the first radio frequency sub-pulse ends.

[0072] After the current RF pulse enters the output state, the controller reads the most recently updated surface temperature monitoring value before sending the trigger control signal for the next RF sub-pulse to be executed. The current RF pulse ends normally when all planned sub-pulses are completed. When the surface temperature monitoring value first reaches the upper limit of the safe temperature, the subsequent RF sub-pulse output stops and cooling is performed. The number of RF pulses already executed remains at the increased value.

[0073] After the current radio frequency pulse ends, the radio frequency sub-pulses that have not yet been executed are not transferred to the next radio frequency pulse. The next radio frequency pulse re-establishes the radio frequency output parameters and the planned number of sub-pulses according to the corresponding action zone and sensitive skin adaptation mode, and is limited by the number of remaining radio frequency pulses in the corresponding action zone.

[0074] XIII. Control Results If the RF pulse is blocked due to safe temperature conditions before the first RF sub-pulse is output, the number of RF pulses already executed will not increase. After the RF pulse has completed the first RF sub-pulse output, even if it ends prematurely due to the surface temperature reaching the upper limit of the safe temperature, the number of RF pulses already executed will still maintain the increased value. Since the remaining number of RF pulses is determined by the planned number of RF pulses and the number of RF pulses already executed, an RF pulse that has ended prematurely due to incomplete execution will not regain a planned output count.

[0075] Meanwhile, the radio frequency sub-pulses that have not yet been executed in the prematurely terminated radio frequency pulse do not enter the parameter formation path of the next radio frequency pulse. The next radio frequency pulse will still redetermine the radio frequency output power, pulse duration and planned number of sub-pulses according to its corresponding action zone and sensitive skin adaptation mode. This ensures that the radio frequency output that is canceled after the safety temperature condition is triggered will not be re-formed into additional output by increasing the number of sub-pulses of the next radio frequency pulse, increasing the radio frequency output power, extending the pulse duration or increasing the number of planned radio frequency pulses.

[0076] The above process can be implemented using the controller's partition status recording, temperature data reading, radio frequency sub-pulse triggering control, and cooling control, without the need to introduce automatic spatial positioning, automatic skin type diagnosis, impedance adaptive radio frequency output, or cross-radio frequency pulse energy compensation structure.

[0077] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0078] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for safe control of monopolar radio frequency output adapted to sensitive skin, applied to a non-invasive monopolar radio frequency device with a loopback, characterized in that, include: S1. Obtain the current action zone, the planned number of radio frequency pulses for the action zone, and the sensitive skin adaptation mode. Determine the radio frequency output power, pulse duration, cooling intensity, and planned number of sub-pulses for the current radio frequency pulse based on the current action zone and the sensitive skin adaptation mode. Read the number of radio frequency pulses executed in the current action zone. S2. Before the current radio frequency pulse is started, the surface temperature monitoring value is obtained; when the surface temperature monitoring value reaches the upper limit of the safe temperature, the current radio frequency pulse is not triggered, and the number of executed radio frequency pulses remains unchanged; when the surface temperature monitoring value is lower than the upper limit of the safe temperature, the first radio frequency sub-pulse is triggered, and after confirming that the first radio frequency sub-pulse has been completed, the number of executed radio frequency pulses is increased by one. S3. During the current RF pulse output, update the number of executed sub-pulses and obtain the updated surface temperature monitoring value before the next RF sub-pulse to be executed is triggered; when the number of executed sub-pulses reaches the planned number of sub-pulses, end the current RF pulse; When the number of executed sub-pulses has not reached the planned number of sub-pulses and the surface temperature monitoring value reaches the upper limit of the safe temperature, the output of subsequent radio frequency sub-pulses is stopped and cooling is performed. The number of executed radio frequency pulses is maintained at the value increased after the first radio frequency sub-pulse is completed. S4. After the current radio frequency pulse ends, the remaining number of radio frequency pulses is determined based on the planned number of radio frequency pulses and the number of radio frequency pulses already executed. When the remaining number of radio frequency pulses is greater than zero, the next radio frequency pulse re-determines the radio frequency output power, pulse duration, cooling intensity, and planned number of sub-pulses according to the corresponding action zone and sensitive skin adaptation mode. The number of radio frequency sub-pulses that were not executed in the previous radio frequency pulse because the surface temperature monitoring value reached the upper limit of the safe temperature is not used as the basis for increasing the planned number of sub-pulses, radio frequency output power, pulse duration, or the planned number of radio frequency pulses for the action zone in the next radio frequency pulse.

2. The method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 1, characterized in that: When determining the RF output power, pulse duration, and cooling intensity of the current RF pulse, the candidate RF output parameter combination corresponding to the current action zone is obtained according to the preset partition parameter mapping relationship, and the RF output parameter combination used by the current RF pulse is determined from the candidate RF output parameter combinations according to the sensitive muscle adaptation mode. Each of the aforementioned combinations of RF output parameters includes corresponding RF output power, pulse duration, and cooling intensity.

3. The method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 2, characterized in that: The partition parameter mapping relationship is pre-established based on the reference energy density range corresponding to different functional partitions, so that each functional partition corresponds to the corresponding reference energy density range and RF output parameter combination. During the RF output process, the established partition parameter mapping relationship is read according to the current active partition, and the candidate RF output parameter combination corresponding to the current active partition is obtained accordingly.

4. The method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 3, characterized in that: When determining the combination of RF output parameters, for the same pulse duration, the RF output power corresponding to the sensitive area is lower than that corresponding to the non-sensitive area; When the same functional zone corresponds to multiple combinations of RF output parameters with different pulse durations, the RF output power corresponding to the longer pulse duration is lower than the RF output power corresponding to the shorter pulse duration.

5. The method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 4, characterized in that: The planned number of sub-pulses is determined based on the preset sub-pulse configuration relationship, using the pulse duration of the current radio frequency pulse and the sub-pulse duration. The current radio frequency pulse is composed of multiple radio frequency sub-pulses corresponding to the planned number of sub-pulses in sequence. When establishing the next radio frequency pulse, the planned number of sub-pulses is re-determined according to the pulse duration and sub-pulse configuration relationship corresponding to the next radio frequency pulse.

6. The method for safe control of unipolar radio frequency output adapted for sensitive skin according to claim 1, characterized in that: The surface temperature detection values ​​of multiple temperature monitoring points within the working electrode's effective range are obtained. The multiple surface temperature detection values ​​obtained at the same sampling time are compared, and the maximum value is determined as the surface temperature monitoring value at the sampling time. Each time a safe temperature judgment is performed, the most recently updated surface temperature monitoring value is used.

7. A method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 6, characterized in that: When the surface temperature monitoring value reaches the upper limit of the safe temperature, cooling is performed according to the cooling intensity corresponding to the current radio frequency pulse, and the surface temperature monitoring value continues to be acquired; When the reacquired surface temperature monitoring value is lower than the upper limit of the safe temperature, the radio frequency output restriction formed by the temperature condition is lifted. After the radio frequency output restriction is lifted, the radio frequency output is not automatically triggered. Instead, the temperature judgment before the current radio frequency pulse is started is re-executed after a new radio frequency pulse output command is received.

8. A method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 1, characterized in that: The current radio frequency pulse is set to an inactive state, an output state, or an end state. The inactive state is maintained until the first radio frequency sub-pulse is output. After the first radio frequency sub-pulse is output, the current radio frequency pulse is updated to the output state, and the number of executed radio frequency pulses of the current active partition is increased simultaneously. When all planned sub-pulses have been executed or when the output of subsequent RF sub-pulses is stopped due to the surface temperature monitoring value reaching the upper limit of the safe temperature, the current RF pulse is updated to the end state. When entering the end state from the output state, the number of RF pulses that have been executed is not rolled back.

9. A method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 1, characterized in that: For different functional zones, the corresponding planned RF pulse count and executed RF pulse count are saved separately. When switching from the current action zone to another action zone, the number of radio frequency pulses executed in the current action zone is saved, and the planned number of radio frequency pulses and the number of radio frequency pulses executed in the action zone after the switch are read. When selecting a function partition that has already performed RF output, read the number of RF pulses previously saved for that function partition.

10. A method for safe control of unipolar radio frequency output adapted to sensitive skin according to claim 9, characterized in that: After selecting the action zone that has already been executed for RF output, the remaining number of RF pulses is determined by the difference between the planned number of RF pulses for the action zone and the number of RF pulses already executed. When the remaining number of radio frequency pulses is greater than zero, it is permissible to establish a new radio frequency pulse for the active zone; When the remaining number of radio frequency pulses is zero, no new radio frequency pulses are established for the active zone, and no new radio frequency pulse trigger control signal is generated for the active zone.

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