Method for alerting of an ultrasound treatment device and ultrasound treatment device

Abstract

This invention relates to the field of medical device technology, and discloses an early warning method and an ultrasound therapy device. The method includes: acquiring target parameter values ​​of a target object, including the target object's temperature value, impedance value, and / or ultrasound reflectivity; the temperature value indicates the temperature of the current treatment area, and the ultrasound reflectivity is obtained based on the incident and reflected ultrasound wave energy; and issuing an alarm when one or more of the target parameter values ​​fall within a risk value range. This invention monitors the ultrasound therapy process from multiple angles, which not only maximizes safety during ultrasound therapy but also ensures therapeutic efficacy.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an early warning method for an ultrasound therapy device and the ultrasound therapy device itself. Background Technology

[0002] In the field of medical aesthetics, ultrasound therapy devices have been widely used due to their significant effects on skin tightening and anti-aging. However, existing ultrasound therapy devices have many unresolved safety issues. One major problem is that most ultrasound therapy devices rely solely on temperature sensors (such as NTC thermistors) to monitor skin surface temperature (measurement depth ≤ 0.3mm), failing to capture temperature changes in the dermis (0.5-2.0mm) and fascia (2.0-4.5mm) layers. Since ultrasound energy primarily acts on these two layers, a normal surface temperature does not necessarily mean that deeper tissues are not overheated. Furthermore, ultrasound therapy devices may also suffer from insufficient ultrasound energy reaching the dermis and fascia layers, leading to unsatisfactory treatment results. Therefore, relying solely on temperature monitoring cannot provide effective early warning for ultrasound therapy. Summary of the Invention

[0003] This invention provides an early warning method and an ultrasound therapy device to solve the problem that ultrasound therapy devices cannot provide effective early warning.

[0004] In a first aspect, the present invention provides an early warning method for an ultrasound therapy device, comprising:

[0005] Obtain the target parameter values ​​of the target object, including temperature value, impedance value and / or ultrasonic reflectivity; the temperature value is used to indicate the temperature of the current treatment area, and the ultrasonic reflectivity is obtained based on the ultrasonic incident wave energy and ultrasonic reflected wave energy; An alarm is triggered if one or more of the target parameter values ​​fall within the risk range.

[0006] In a second aspect, the present invention provides an early warning device for an ultrasound therapy device, the device comprising: The acquisition module is used to acquire the target parameter values ​​of the target object. The target parameter values ​​include temperature value, impedance value and / or ultrasonic reflectivity. The temperature value is used to indicate the temperature of the current treatment area, and the ultrasonic reflectivity is obtained based on the ultrasonic incident wave energy and the ultrasonic reflected wave energy. The alarm module is used to issue an alarm when one or more of the target parameter values ​​fall within the risk value range.

[0007] Thirdly, the present invention provides an ultrasound therapy device, comprising: an ultrasound therapy device main unit and an ultrasound therapy head, wherein the ultrasound therapy head includes an ultrasound transducer; The main unit of the ultrasound therapy device includes a memory and a processor, which are interconnected. The memory stores computer instructions, and the processor executes the computer instructions to perform the warning method described in the first aspect or any of its corresponding embodiments.

[0008] Fourthly, the present invention provides a computer-readable storage medium storing computer instructions for causing a computer to execute the warning method of the first aspect or any corresponding embodiment thereof.

[0009] Fifthly, the present invention provides a computer program product, including computer instructions for causing a computer to execute the warning method of the first aspect or any corresponding embodiment described above.

[0010] The early warning method and ultrasound therapy device provided in this embodiment of the invention monitor multiple parameters during the ultrasound therapy process, including temperature, impedance value, and / or ultrasound reflectivity. This allows for multi-faceted monitoring of the ultrasound therapy process. Temperature, impedance value, and ultrasound reflectivity can be used to monitor safety risks during ultrasound therapy. Impedance value and ultrasound reflectivity can be used to monitor the ultrasound energy reaching deep tissues during ultrasound therapy, preventing insufficient energy from affecting the treatment effect. Therefore, the early warning method for ultrasound therapy device provided in this embodiment not only maximizes safety during ultrasound therapy but also ensures treatment effectiveness, achieving comprehensive protection. Attached Figure Description

[0011] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0012] Figure 1 This is a flowchart illustrating an early warning method for an ultrasound therapy device according to an embodiment of the present invention; Figure 2 This is a schematic diagram of ultrasonic transmission and reception according to an embodiment of the present invention; Figure 3 This is a structural block diagram of an early warning device for an ultrasound therapy device according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the hardware structure of the main unit of the ultrasound therapy device according to an embodiment of the present invention. Detailed Implementation

[0013] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, 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, 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.

[0014] It is understood that before using the technical solutions disclosed in the various embodiments of the present invention, users should be informed of the types, scope of use, and usage scenarios of the personal information involved in the present invention and their authorization should be obtained in accordance with relevant laws and regulations through appropriate means.

[0015] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0016] According to an embodiment of the present invention, an embodiment of an early warning method for an ultrasound therapy device is provided. It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions. Furthermore, although a logical order is shown in the flowchart, in some cases, the steps shown or described may be executed in a different order than that shown here.

[0017] This embodiment provides an early warning method for ultrasound therapy devices. Figure 1 This is a flowchart of an early warning method for an ultrasound therapy device according to an embodiment of the present invention, such as... Figure 1 As shown, the process includes the following steps: Step S101: Obtain the target parameter values ​​of the target object. The target parameter values ​​include the temperature value, the impedance value of the target object, and / or the ultrasonic reflectivity. The temperature value is used to indicate the temperature of the current treatment area, and the ultrasonic reflectivity is obtained based on the ultrasonic incident wave energy and the ultrasonic reflected wave energy.

[0018] Specifically, the temperature value can be obtained using a temperature sensor; the impedance value can be obtained using an impedance sensor; and the ultrasonic reflected wave energy can be obtained using an ultrasonic reflectivity detector.

[0019] Step S102: If one or more of the target parameter values ​​fall within the risk value range, an alarm is triggered.

[0020] The early warning method for ultrasound therapy equipment provided in this embodiment monitors multiple parameters during the ultrasound therapy process, including temperature, impedance value, and / or ultrasound reflectivity. This allows for multi-faceted monitoring of the ultrasound therapy process. Temperature, impedance value, and ultrasound reflectivity can be used to monitor safety risks during ultrasound therapy. Impedance value and ultrasound reflectivity can be used to monitor the ultrasound energy reaching deep skin tissues during ultrasound therapy, preventing insufficient energy from affecting the treatment effect. Therefore, the early warning method for ultrasound therapy equipment provided in this embodiment not only maximizes safety during ultrasound therapy but also ensures treatment effectiveness, providing comprehensive protection.

[0021] The early warning method provided in this embodiment can be executed by the processor in the host of the ultrasound therapy device. The processor can be an ARM Cortex-M4 processor (e.g., STM32F429VET), with a main frequency of 180MHz, 192KB RAM and 512KB Flash, supporting floating-point operations, and meeting the real-time processing requirements of multiple parameters.

[0022] The sensors used to collect the values ​​of various target parameters will be discussed in detail below.

[0023] In some optional embodiments, the temperature sensor is located on and protrudes from the surface of the ultrasonic treatment head, so that the skin temperature can be adequately measured when the ultrasonic treatment head comes into contact with the skin.

[0024] In some alternative embodiments, the temperature sensor can be embedded in the heat insulation layer inside the ultrasonic treatment head. Specifically, the heat insulation layer inside the ultrasonic treatment head can be a ceramic heat insulation layer with a thickness of 0.8 mm. In this embodiment, embedding the temperature sensor in the heat insulation layer inside the ultrasonic treatment head can avoid temperature interference caused by direct contact between the temperature sensor and the transducer.

[0025] In addition, multiple temperature sensors can be distributed at equal intervals, for example, three sensors arranged in an equilateral triangle to ensure coverage of the core area where the ultrasound energy is applied. The distance between each pair of temperature sensors can be, for example, 2 mm. In other embodiments, the number of temperature sensors may be two, four, or other types, and the distribution of these temperature sensors is not limited, as long as they can accurately measure the skin temperature of the area where the ultrasound energy is applied (i.e., the current treatment area).

[0026] The temperature sensor can be a type K miniature thermocouple with a probe diameter of 0.5 mm and a length of 3 mm. The wires can be insulated with polytetrafluoroethylene (PTFE) material (temperature range -200℃ to 260℃). The type K miniature thermocouple used in this embodiment has a measurement range of 30-80℃, an accuracy of ±0.2℃ within the critical treatment temperature range of 32-68℃, and a resolution of 0.05℃, meeting the requirements for deep tissue temperature monitoring. Data transmission from the temperature sensor can be performed using differential signal transmission, connected to the ultrasound therapy device host via shielded twisted-pair cable (impedance 120Ω). The transmission delay is ≤50ms, and it has strong anti-electromagnetic interference capabilities (signal-to-noise ratio ≥60dB at the ultrasound therapy device's operating frequency of 1-3MHz), avoiding measurement errors caused by the device's own electromagnetic radiation.

[0027] In addition, the spatial resolution of a thermocouple array composed of multiple thermocouples is high, and multi-point temperature measurement can support thermal imaging. The subcutaneous temperature can be deduced through the heat conduction model, thus enabling temperature monitoring of the dermis and fascia.

[0028] In some optional embodiments, the impedance sensor includes two electrode plates, and the impedance sensor satisfies at least one of the following: The electrode pads are made of pure silver; The surface of the electrode sheet is coated with titanium nitride.

[0029] Specifically, the electrode pads can be made of medical-grade pure silver, with a diameter of 3mm and a thickness of 0.2mm. The surface of the electrode pads can be coated with a titanium nitride coating (50nm thick) to improve their biocompatibility and corrosion resistance. The spacing between two electrode pads can be 5mm. Additionally, the electrode pads can be fitted to the skin with an elastic silicone pad to ensure uniform pressure and avoid impedance measurement errors caused by pressure differences.

[0030] In this embodiment, skin impedance measurement can be performed using the AC impedance method. Specifically, a constant AC current of 1kHz and 500μA can be output through two electrode pads. Then, the skin impedance value (Z=U / I) is calculated by measuring the voltage difference across the electrode pads (range 0.25-2.5V). The measurement range is 500-5000Ω, with an accuracy of ±5% and a resolution of 1Ω within the 1000-2000Ω range (normal treatment impedance range).

[0031] In ultrasound therapy, skin impedance is a crucial parameter reflecting ultrasound energy absorption. Skin impedance is primarily determined by the amount of coupling agent. Insufficient coupling agent leads to residual air reflecting or scattering ultrasound waves, resulting in energy loss exceeding 90%. Insufficient energy in deep tissues negatively impacts treatment efficacy. Conversely, excessive coupling agent increases the propagation distance of sound waves within the medium, causing energy attenuation (attenuation coefficient approximately 0.3–0.5 dB / cm / MHz), also resulting in insufficient energy reception in deep tissues. An impedance > 2500 Ω indicates insufficient coupling agent (thickness < 0.2 mm), at which point energy reflectivity increases by 5%–10%. An impedance < 800 Ω indicates coupling agent buildup (thickness > 1 mm), leading to energy attenuation, reduced penetration depth, multiple reflections within the coupling agent layer, and uneven energy distribution. Therefore, monitoring skin impedance ensures optimal treatment outcomes.

[0032] In some optional embodiments, the ultrasonic reflectivity detector (also known as an ultrasonic reflective energy detector) includes an ultrasonic receiving transducer (specifically a piezoelectric receiving crystal), a preamplifier, and a signal conditioning circuit. The ultrasonic receiving transducer is used to receive ultrasonic reflected waves and output electrical signals. The preamplifier is used to amplify the electrical signals output by the ultrasonic receiving transducer. The signal conditioning circuit is used to perform subsequent processing on the electrical signals output by the preamplifier, such as filtering, isolation, linearization, bias adjustment, or impedance matching.

[0033] In some optional embodiments, the ultrasonic receiving transducer of the ultrasonic reflectivity detector is a device independent of the ultrasonic transmitting transducer, which is used to transmit ultrasonic incident waves. An ultrasonic transmitting transducer is located in the central region of the ultrasonic treatment head; the ultrasonic receiving transducer of the ultrasonic reflectivity detector is located at the edge of the ultrasonic treatment head, and the ultrasonic receiving surface of the ultrasonic receiving transducer and the ultrasonic transmitting surface of the ultrasonic transmitting transducer form a preset angle, such as 135 degrees.

[0034] Specifically, for example Figure 2 As shown, the ultrasonic receiving transducer 201 of the ultrasonic reflectivity detector is disposed on the side of the ultrasonic transmitting transducer 202, and can be at a preset angle to the ultrasonic transmitting transducer 202, for example, an angle of 135 degrees. In this embodiment, during ultrasonic therapy, the transducer used to emit ultrasound continuously outputs incident waves 203. To reduce interference, this transducer is not reused to receive ultrasonic reflected waves 204, but a separate ultrasonic receiving transducer is set up to receive the reflected waves. The ultrasonic receiving transducer for receiving reflected waves is set at a certain angle to the ultrasonic transmitting transducer, which can shield stray sound waves (such as internal reflections of the equipment and environmental noise) 205 in the non-reflection direction, thereby improving the signal-to-noise ratio.

[0035] Specifically, the preamplifier gain can be 20dB, and the bandwidth can be 1-10MHz. The filtering frequency of the filter circuit in the signal conditioning circuit can be 1-3MHz.

[0036] In this embodiment, after obtaining the ultrasonic reflected wave energy, its corresponding peak voltage V can be... 反射 Divide by the peak voltage V corresponding to the incident ultrasonic wave energy 入射 The ultrasonic reflectivity R (R=V) can then be obtained. 反射 / V 入射 (×100%). In this embodiment, the measurement range of ultrasonic reflectivity is 5%-40%, with an accuracy of ±1% and a resolution of 0.1%.

[0037] In other alternative embodiments, the ultrasonic transmitting transducer can be reused as the ultrasonic receiving transducer of the ultrasonic reflectivity detector. That is, the same ultrasonic transducer can be time-division multiplexed as both the ultrasonic transmitting transducer and the ultrasonic receiving transducer of the ultrasonic reflectivity detector.

[0038] During normal ultrasound treatment, the reflectivity should be maintained between 10% and 20%. When the reflectivity is >25%, it indicates that the energy is not effectively applied to the target tissue (e.g., insufficient coupling agent, dry skin), and the unabsorbed energy will be converted into heat and accumulate on the skin surface. When the reflectivity is <8%, it indicates that the energy penetrates excessively (e.g., coupling agent buildup, excessive skin moisture content), which may damage the subcutaneous fat layer and nerves. Therefore, monitoring the ultrasound reflectivity can avoid the safety risks caused by excessive temperature and ensure the treatment effect.

[0039] In some optional embodiments, the early warning method for the ultrasound therapy device provided in this embodiment may further include: The amount of coupling agent used is determined based on the impedance value and / or ultrasonic reflectivity. The amount of coupling agent used includes excessive coupling agent, insufficient coupling agent, and appropriate coupling agent. If it is determined that the amount of coupling agent used is excessive or insufficient, a corresponding prompt message will be output. Specifically, the prompt message can be displayed on the screen as a reminder text or graphic indicating excessive or insufficient coupling agent.

[0040] Therefore, doctors can remove, spread, or add coupling agent according to the prompts to ensure the treatment effect.

[0041] The early warning mechanisms of ultrasound therapy devices in related technologies are mainly based on a single trigger condition: "parameters exceeding a safety threshold." For example, an alarm is only triggered when the monitored temperature exceeds a threshold. However, by this time, the skin tissue has already suffered minor thermal damage, and the collagen fibers in the dermis have begun to degenerate. Furthermore, these ultrasound therapy devices only perform a simple and singular "shutdown" operation after an alarm, without fully considering the differences in risk levels. In reality, the risk level to skin tissue varies drastically at a certain temperature threshold. A uniform shutdown operation not only severely impacts treatment efficiency but may also lead to uneven distribution of ultrasound energy in the skin tissue due to sudden interruptions in the treatment process, resulting in significant differences in local treatment effects.

[0042] The following example illustrates the judgment logic of the early warning method for ultrasound therapy equipment.

[0043] In some optional implementations, before issuing an alarm when one or more of the target parameter values ​​fall within the risk value range, the following steps are also included: The target parameter values ​​are processed by moving average filtering.

[0044] Different moving average filtering methods can be used for different target parameter values. For example, for temperature data (sampling frequency of 10 times / second), a 5-point moving average algorithm (y(n)=(x(n)+x(n-1)+x(n-2)+x(n-3)+x(n-4)) / 5, where x(n) is the currently collected temperature value, and x(n-1), x(n-2), x(n-3), and x(n-4) are the temperature values ​​collected in the previous four times) can be used to remove abnormal values ​​caused by instantaneous electromagnetic interference (such as a sudden false temperature of 45℃). For impedance data (sampling frequency of 5 times / second) and reflectivity data (sampling frequency of 3 times / second), a 3-point moving average algorithm can be used to balance data stability and response speed.

[0045] In summary, in this embodiment, abnormal interference values ​​can be removed by performing moving average filtering on the collected target parameter value data, thereby improving data stability, enhancing the reliability of early warning, and reducing the probability of false alarms.

[0046] In addition, the validity of the target parameter values ​​can be judged. For example, if a sensor outputs a value that exceeds the measurement range three times in a row (such as temperature > 50℃, impedance > 5000Ω), it is determined to be a sensor fault, the equipment is immediately triggered to stop, and the display screen used for human-machine interaction displays "[Sensor type] fault, please check" (such as "Temperature sensor fault, please check").

[0047] In some optional implementations, one target parameter corresponds to multiple risk value ranges; Step S102 above, that is, issuing an alarm when one or more of the target parameter values ​​fall within the risk value range, includes: Step S1021: Determine the current risk level based on the risk value range that the target parameter value falls into; the higher the risk level, the greater the risk. Step S1022: Execute the alarm operation corresponding to the risk level.

[0048] In this embodiment, risk alerts are issued in different levels so that doctors can distinguish the current risk level and perform operations appropriate to the risk level.

[0049] Specifically, when determining the current risk level, in addition to considering which risk value range the target parameter value falls into, we can also take into account the magnitude and / or duration of the target parameter value exceeding the risk value range and / or the number of target parameters falling into the risk value range (that is, how many types of target parameter values ​​fall into their corresponding risk value ranges).

[0050] The calculation method for exceeding the allowable range is as follows: if it exceeds the upper limit of the safety value, it is calculated based on the upper limit; if it exceeds the lower limit of the safety value, it is calculated based on the lower limit. Of course, the calculation method for exceeding the allowable range is not limited to the one described here, and the calculation method can be selected according to actual needs.

[0051] In some optional implementations, the risk value range includes two different ranges: a first risk value range (also known as a warning range) and a second risk value range (also known as an emergency range). The first risk value range is closer to the safe value range than the second risk value range. Based on the risk value range that the target parameter value falls into, the current risk level is determined, including: If the target parameter value satisfies one of the two first conditions, then the current risk level is determined to be Level 1; If the target parameter value satisfies one of the three second conditions, then the current risk level is determined to be level two; If the target parameter value satisfies one of the three third conditions, then the current risk level is determined to be level three; Among them, the two first conditions are: one of the target parameter values ​​falls into the corresponding first risk value range, and the magnitude of exceeding the safety value does not exceed the first magnitude threshold; one of the target parameter values ​​falls into the corresponding first risk value range, and changes towards the safety value range for a continuous first preset time.

[0052] The first amplitude threshold can be different for different target parameters. For example, the first amplitude threshold for temperature can be 3%, while the first amplitude threshold for impedance can be 10%. For instance, if the temperature is 44.5℃, it exceeds the upper limit of the safe value (safe value range is 40-44 degrees) by 0.5℃, which is an exceedance of 1.1%, meaning it does not exceed the first amplitude threshold (3%); if the impedance is 2100Ω, it exceeds the upper limit of the safe value range (safe value range is 1000-2000Ω) by 100Ω, which is an exceedance of 5%, meaning it does not exceed the first amplitude threshold (10%).

[0053] The first preset time can be, for example, 5 seconds. Regarding the change towards the safe range, for example, the safe range for the temperature value is 40-44 degrees. If the temperature value drops from 44.5℃ to 44℃, it means that the temperature value is changing towards the safe range.

[0054] The three second conditions are: two of the target parameter values ​​fall within the corresponding first risk value range; one of the target parameter values ​​falls within the corresponding first risk value range and exceeds the second magnitude threshold by a margin exceeding the safety value; and the current risk level is level one and has been maintained for a second preset time.

[0055] For example, if the temperature is 45℃ (the safe range for temperature is 40-44 degrees, and the first risk range is 44-46 degrees) and the ultrasonic reflectivity (the safe range for ultrasonic reflectivity is 10-20%, and the first risk range includes 8-10% and 20-25%) is 23%, meaning both target parameters fall within the corresponding first risk range, then the current risk level can be determined as Level 2. Alternatively, if the impedance value (the safe range for impedance value is 1000-2000Ω, and the first risk range (also known as the warning range) includes 800-1000Ω and 2000-2500Ω) is 850Ω and the ultrasonic reflectivity (the safe range for ultrasonic reflectivity is 10-20%, and the first risk range includes 8-10% and 20-25%) is 9%, meaning both target parameters fall within the corresponding first risk range, then the current risk level can be determined as Level 2.

[0056] The first and second amplitude thresholds can be equal or unequal. Similarly, the second amplitude threshold can differ for different target parameters. For example, the second amplitude threshold for temperature can be 3%, while the second amplitude threshold for impedance can be 10%. For instance, if the temperature is 45.5℃ and the safe range for temperature is 40-44℃, the excess amplitude is (45.5-44) / 44 = 3.4%. Or, if the impedance is 2400Ω and the safe range for impedance is 1000-2000Ω, the excess amplitude is 20%. The second preset time can be, for example, 3 seconds.

[0057] For example, if the impedance value (the safe range corresponding to the impedance value is 1000-2000Ω, and the first risk range (also known as the warning range) includes 800-1000Ω and 2000-2500Ω) is 850Ω, the excess is (1000-850) / 100=15% (the second amplitude threshold corresponding to the impedance value can be 10%). That is, if one of the target parameter values ​​falls into the corresponding first risk range and exceeds the safe value by more than the second amplitude threshold, then the current risk level can be determined to be level two.

[0058] The two third conditions are: one of the target parameter values ​​falls within the corresponding second risk value range; the current risk level is level one and has lasted for a third preset time; the current risk level is level two and has lasted for a fourth preset time.

[0059] Of course, if two or even three of the target parameter values ​​fall within the corresponding second risk value range, it will certainly be determined as a level three risk level. The third preset time is generally longer than the fourth preset time; for example, the third preset time is 10 seconds, and the fourth preset time is 5 seconds.

[0060] For example, the safe range for temperature values ​​is 40-44 degrees Celsius, the first risk range (also known as the warning range) is 44-46 degrees Celsius, and the second risk range (also known as the emergency range) is greater than 46 degrees Celsius. The safe range for impedance values ​​is 1000-2000Ω, the first risk range (also known as the warning range) includes 800-1000Ω and 2000-2500Ω, and the second risk range (also known as the emergency range) is greater than 2500Ω or less than 800Ω. The safe range for ultrasonic reflectivity is 10-20%, the first risk range (also known as the warning range) includes 8-10% and 20-25%, and the second risk range (also known as the emergency range) is greater than 25% or less than 8%.

[0061] The aforementioned first and second risk value ranges can be adjusted (within ±10%) to suit different treatment sites and skin types. For example, the temperature risk range for periorbital treatment can be reduced by 1-2℃. For sensitive skin, the safe impedance range can be 1200-2200Ω. The first risk range (also known as the warning range) includes 1000-1200Ω and 2200-2700Ω, while the second risk range (also known as the emergency range) is greater than 2700Ω or less than 1000Ω. If the treatment site is the neck, the safe range for ultrasound reflectivity is 12-22%. The first risk range (also known as the warning range) includes 10-12% and 22-27%, while the second risk range (also known as the emergency range) is greater than 27% or less than 10%.

[0062] In some optional implementations, when the risk level is Level 1, the corresponding alarm operation includes at least one of the following: outputting a first prompt tone through a sound output device; displaying a first alarm message through a display screen; or displaying a target parameter value that falls within the risk value range through a display screen.

[0063] Specifically, the sound output device can be, for example, a speaker. The first alert tone can be an intermittent alert tone, with an interval frequency of, for example, 1Hz (0.5 seconds on, 0.5 seconds off), and a volume of 60dB. The first alarm information displayed on the screen can include, for example, a yellow warning icon. In addition, it can display the real-time fluctuation of the target parameter value through a pop-up window and refresh the display of abnormal constants, such as temperature: 45℃.

[0064] When the risk level is level two, the corresponding alarm operation includes at least one of the following: outputting a second prompt tone through the sound output device; displaying a second alarm message on the display screen; displaying the target parameter value that falls within the risk value range on the display screen; or displaying the reason for the abnormal parameter obtained from the analysis on the display screen.

[0065] Specifically, the sound output device could be a speaker, for example. The second alert tone could be a continuous tone with a volume of 70dB, 10dB higher than the first-level risk level, ensuring that doctors can clearly perceive it in noisy environments (such as multi-person treatment rooms). The second alarm information displayed on the screen includes an orange warning interface, and the background color can be changed to orange, displaying the abnormal parameters and cause analysis in the center, such as "Impedance: 2300Ω (Warning), Cause: Insufficient coupling agent, Recommendation: Add coupling agent and then click Resume". Two buttons, "Resume Treatment" and "Pause Treatment", are set at the bottom of the interface.

[0066] When the risk level is level three, the corresponding alarm operation includes at least one of the following: outputting a third prompt tone through the sound output device; displaying a second alarm message on the display screen; displaying the target parameter value that falls within the risk value range on the display screen; or displaying the current risk response operation on the display screen.

[0067] Specifically, the sound output device could be, for example, a speaker. The third alert tone could be a high-frequency alarm tone with a volume of 85dB. The second alarm information displayed on the screen includes a red emergency interface; additionally, the background color can change to red and flash "Emergency Risk! Shutdown," and a parameter details window will pop up (e.g., "Temperature: 42.5℃ (Emergency), Impedance: 2200Ω (Normal), Reflectivity: 19% (Normal)"). Only two buttons, "View Log" and "Contact Technical Support," are provided at the bottom of the interface.

[0068] In some optional embodiments, the early warning method for ultrasound therapy devices also includes: Perform risk response actions corresponding to the risk level; When the risk level is Level 1, the corresponding risk response operation includes at least one of the following: controlling the reduction of the energy output of the ultrasound transducer; controlling the ultrasound transducer to stop the energy output and recording the location of the current treatment area.

[0069] Specifically, for example, the original energy of the ultrasonic transducer is 4.5W, which can be controlled to be reduced to 4.0-4.1W. The position of the current treatment area can be determined by the displacement sensor inside the treatment head, and recording the position of the current treatment area can facilitate precise connection during subsequent recovery treatment.

[0070] In addition, if the abnormal target parameter value falls back into the safe range within a preset time (e.g., 3 seconds), the original energy and treatment path will be automatically restored. However, if the abnormal target parameter value exceeds the preset time within the first risk range, it will be upgraded to a second-level risk.

[0071] When the risk level is level 2, the corresponding risk response actions include at least one of the following: controlling the ultrasonic transducer to stop energy output; locking the movement function of the ultrasonic treatment head.

[0072] Specifically, an electromagnetic lock can be used to lock the movement of the ultrasound treatment head, preventing the treatment position from shifting due to doctor's misoperation.

[0073] After the doctor has addressed the factors causing the abnormal target parameter values ​​(e.g., if the impedance is too high due to insufficient coupling agent, then add coupling agent), they can click the "Resume Treatment" button. The sensor will then re-collect the target parameters. If the parameters return to normal, the treatment head will be unlocked and energy output will be restored. If the parameters are still abnormal, the system will display "Parameters not restored, continue processing." If no action is taken after 5 seconds, the risk level will be upgraded to Level 3.

[0074] When the risk level is level three, the corresponding risk response actions include at least one of the following: disconnecting the power supply circuit of the ultrasound transducer to ensure that energy output completely stops; locking the operating interface of the ultrasound therapy device. Specifically, the device operating interface can be locked via software encryption, allowing only an authorized password (a 6-digit numeric password set by the device administrator) to unlock it. After unlocking, the sensor self-check must be performed again, and treatment can only be restarted after confirming that there are no abnormalities.

[0075] In this embodiment, the ultrasound therapy device implements risk response in a graded manner, which not only ensures safety during the treatment process but also maximizes treatment efficiency. Furthermore, it avoids the problem of uneven distribution of ultrasound energy in skin tissue, which could lead to significant differences in local treatment effects.

[0076] In summary, this embodiment provides an early warning method capable of comprehensive, real-time, and precise monitoring and warning of the ultrasound treatment process. Specifically, this method monitors three-dimensional parameters such as temperature, skin impedance, and ultrasound reflectivity to achieve comprehensive and refined control over skin condition and the ultrasound energy transfer process, thus fully grasping key information during treatment. The method also provides a dynamic risk assessment algorithm based on moving average filtering. Utilizing advanced data analysis and processing technology, it can accurately identify potential safety hazards 0.5-1 second in advance, effectively preventing deep tissue damage caused by parameter exceeding limits and nipping risks in the bud. Furthermore, this embodiment intelligently executes differentiated operations such as "energy reduction-pause-shutdown" based on different risk levels. While ensuring treatment safety, it minimizes unnecessary treatment interruptions, improving treatment efficiency and patient experience.

[0077] This embodiment also provides an early warning device for an ultrasound therapy device, which is used to implement the above embodiments and preferred embodiments; details already described will not be repeated. As used below, the term "module" can refer to a combination of software and / or hardware that performs a predetermined function. Although the device described in the following embodiments is preferably implemented in software, hardware implementation, or a combination of software and hardware, is also possible and contemplated.

[0078] This embodiment provides an early warning device for an ultrasound therapy device, such as... Figure 3 As shown, it includes: The acquisition module 301 is used to acquire the target parameter values ​​of the target object. The target parameter values ​​include temperature value, impedance value and / or ultrasonic reflectivity. The temperature value is used to indicate the temperature of the current treatment area, and the ultrasonic reflectivity is obtained based on the ultrasonic incident wave energy and the ultrasonic reflected wave energy. The alarm module 302 is used to issue an alarm when one or more of the target parameter values ​​fall within the range of risk values.

[0079] In some alternative implementations, the temperature value is acquired using a temperature sensor; The temperature sensor is located on the surface of the ultrasonic treatment head and protrudes from the surface of the ultrasonic treatment head; and / or, there are multiple temperature sensors that are evenly distributed.

[0080] In some alternative implementations, the impedance value is acquired using an impedance sensor comprising two electrode plates, and the impedance sensor satisfies at least one of the following: The electrode pads are made of pure silver; The surface of the electrode sheet is coated with titanium nitride.

[0081] In some alternative implementations, the warning device for the ultrasound therapy equipment further includes: The coupling agent dosage judgment module is used to determine the amount of coupling agent based on the impedance value and / or ultrasonic reflectivity. The amount of coupling agent includes excessive coupling agent, insufficient coupling agent, and appropriate coupling agent. The prompt module is used to output corresponding prompt information if it is determined that the amount of coupling agent used is excessive or insufficient.

[0082] In some alternative implementations, the ultrasonic reflected wave energy is acquired using an ultrasonic reflectivity detector; the ultrasonic reflectivity detector includes an ultrasonic receiving transducer, a preamplifier, and a signal conditioning circuit; the ultrasonic receiving transducer is used to receive ultrasonic reflected waves and output electrical signals, the preamplifier is used to amplify the electrical signals output by the ultrasonic receiving transducer, and the signal conditioning circuit is used to perform subsequent processing on the electrical signals output by the preamplifier.

[0083] In some alternative implementations, the ultrasonic receiving transducer of the ultrasonic reflectivity detector is multiplexed with the ultrasonic transmitting transducer; or, the ultrasonic receiving transducer is a device independent of the ultrasonic transmitting transducer; wherein the ultrasonic transmitting transducer is used to transmit ultrasonic incident waves. In the case where the ultrasonic receiving transducer is independent of the ultrasonic transmitting transducer, the ultrasonic transmitting transducer is located in the central region of the ultrasonic treatment head, and the ultrasonic receiving transducer of the ultrasonic reflectivity detector is located at the edge of the ultrasonic treatment head, with the ultrasonic receiving surface of the ultrasonic receiving transducer and the ultrasonic transmitting surface of the ultrasonic transmitting transducer forming a preset angle.

[0084] In some alternative implementations, the warning device for the ultrasound therapy equipment further includes: The data processing module is used to perform moving average filtering on the target parameter values ​​respectively.

[0085] In some alternative implementations, one target parameter corresponds to multiple risk value ranges; Alarm module 302 includes: The risk level determination unit is used to determine the current risk level based on the range of risk values ​​that the target parameter value falls into; the higher the risk level, the greater the risk. The alarm operation execution unit is used to execute alarm operations corresponding to the risk level.

[0086] In some alternative implementations, the risk value range includes two distinct ranges: a first risk value range and a second risk value range, wherein the first risk value range is closer to the safe value range than the second risk value range. The risk level determination unit is specifically used for: If the target parameter value satisfies one of the two first conditions, then the current risk level is determined to be Level 1; If the target parameter value satisfies one of the three second conditions, then the current risk level is determined to be level two; If the target parameter value satisfies one of the three third conditions, then the current risk level is determined to be level three; The two first conditions are: one of the target parameter values ​​falls within the corresponding first risk value range, and the magnitude of exceeding the safety value does not exceed the first magnitude threshold; one of the target parameter values ​​falls within the corresponding first risk value range, and changes towards the safety value range for a continuous first preset time. The three second conditions are: two of the target parameter values ​​fall within the corresponding first risk value range; one of the target parameter values ​​falls within the corresponding first risk value range and exceeds the second magnitude threshold by a margin exceeding the safety value; the current risk level is level one and has been maintained for a second preset time. The two third conditions are: one of the target parameter values ​​falls within the corresponding second risk value range; the current risk level is level one and has lasted for a third preset time; the current risk level is level two and has lasted for a fourth preset time.

[0087] In some optional implementations, when the risk level is Level 1, the corresponding alarm operation includes at least one of the following: outputting a first prompt tone through a sound output device; displaying a first alarm message through a display screen; or displaying a target parameter value that falls within the risk value range through a display screen. When the risk level is level two, the corresponding alarm operation includes at least one of the following: outputting a second prompt tone through the sound output device; displaying a second alarm message on the display screen; displaying the target parameter value that falls within the risk value range on the display screen; or displaying the reason for the abnormal parameter obtained from the analysis on the display screen. When the risk level is level three, the corresponding alarm operation includes at least one of the following: outputting a third prompt tone through the sound output device; displaying a second alarm message on the display screen; displaying the target parameter value that falls within the risk value range on the display screen; or displaying the current risk response operation on the display screen.

[0088] In some alternative implementations, the warning device for the ultrasound therapy equipment further includes: The risk response module is used to execute risk response operations corresponding to the risk level; When the risk level is Level 1, the corresponding risk response operation includes at least one of the following: controlling the reduction of the energy output of the ultrasound transducer; controlling the ultrasound transducer to stop the energy output and recording the location of the current treatment area; When the risk level is level 2, the corresponding risk response actions include at least one of the following: controlling the ultrasound transducer to stop energy output; locking the movement function of the ultrasound treatment head; When the risk level is level three, the corresponding risk response actions include at least one of the following: disconnecting the power supply circuit of the ultrasound transducer; locking the operating interface of the ultrasound therapy equipment.

[0089] The early warning device for ultrasound therapy equipment provided in this embodiment of the invention can execute the early warning method for ultrasound therapy equipment provided in any embodiment of the invention, and has the corresponding functional modules and beneficial effects for executing the method. Further functional descriptions of the various modules and units described above are the same as in the corresponding embodiments described above, and will not be repeated here.

[0090] The ultrasonic therapy equipment consists of a main unit and an ultrasonic therapy head, the latter including an ultrasonic transducer. Figure 4 This is a schematic diagram of the main unit of an ultrasound therapy device provided in an embodiment of the present invention. See below for details. Figure 4 The diagram illustrates a structural schematic suitable for implementing the ultrasound therapy device host in embodiments of the present invention. The ultrasound therapy device host may include a processor (e.g., a central processing unit, graphics processor, etc.) 401, which can perform various appropriate actions and processes according to a program stored in read-only memory (ROM) 402 or a program loaded from memory 408 into random access memory (RAM) 403. The RAM 403 also stores various programs and data required for the operation of the ultrasound therapy device host. The processor 401, ROM 402, and RAM 403 are interconnected via a bus 404. An input / output (I / O) interface 405 is also connected to the bus 404.

[0091] Typically, the following devices can be connected to I / O interface 405: input devices 406 including, for example, touchscreens, touchpads, keyboards, mice, cameras, microphones, accelerometers, gyroscopes, etc.; output devices 407 including, for example, liquid crystal displays (LCDs), speakers, vibrators, etc.; memory devices 408 including, for example, magnetic tapes, hard disks, etc.; and communication devices 409. Communication device 409 allows the ultrasound therapy device host to communicate wirelessly or wiredly with other devices to exchange data. Although Figure 4 An ultrasound therapy device main unit with various devices is shown, but it should be understood that it is not required to implement or have all of the devices shown, and more or fewer devices may be implemented or have instead.

[0092] In particular, according to embodiments of the present invention, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of the present invention include a computer program product comprising a computer program carried on a non-transitory computer-readable medium, the computer program containing program code for performing the methods shown in the flowcharts. In such embodiments, the computer program can be downloaded and installed from a network via a communication device 409, or installed from a memory 408, or installed from a ROM 402. When the computer program is executed by the processor 401, it performs the functions defined in the warning method for the ultrasound therapy device of the embodiments of the present invention.

[0093] Figure 4 The ultrasound therapy device main unit shown is merely an example and should not be construed as limiting the functionality and scope of use of the embodiments of the present invention.

[0094] This invention also provides a computer-readable storage medium. The methods described above according to embodiments of the invention can be implemented in hardware or firmware, or implemented as computer code that can be recorded on a storage medium, or implemented as computer code downloaded via a network and originally stored on a remote storage medium or a non-transitory machine-readable storage medium and then stored on a local storage medium. Thus, the methods described herein can be processed by software stored on a storage medium using a general-purpose computer, a dedicated processor, or programmable or dedicated hardware. The storage medium can be a magnetic disk, optical disk, read-only memory, random access memory, flash memory, hard disk, or solid-state drive, etc.; further, the storage medium can also include combinations of the above types of memory. It is understood that the computer, processor, microprocessor controller, or programmable hardware includes storage components capable of storing or receiving software or computer code. When the software or computer code is accessed and executed by the computer, processor, or hardware, the early warning method for the ultrasound therapy device shown in the above embodiments is implemented.

[0095] A portion of this invention can be applied as a computer program product, such as computer program instructions, which, when executed by a computer, can invoke or provide the methods and / or technical solutions according to the invention through the operation of the computer. Those skilled in the art will understand that the forms in which computer program instructions exist in a computer-readable medium include, but are not limited to, source files, executable files, installation package files, etc. Correspondingly, the ways in which computer program instructions are executed by a computer include, but are not limited to: the computer directly executing the instructions, or the computer compiling the instructions and then executing the corresponding compiled program, or the computer reading and executing the instructions, or the computer reading and installing the instructions and then executing the corresponding installed program. Here, the computer-readable medium can be any available computer-readable storage medium or communication medium accessible to a computer.

[0096] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A method for early warning of an ultrasound therapy device, characterized in that, The method includes: Obtain target parameter values ​​for the target object, including temperature values, impedance values, and / or ultrasonic reflectivity of the target object; the temperature value is used to indicate the temperature of the current treatment area, and the ultrasonic reflectivity is obtained based on the incident ultrasonic wave energy and the reflected ultrasonic wave energy; An alarm is triggered if one or more of the target parameter values ​​fall within the risk value range.

2. The method according to claim 1, characterized in that, The temperature value was obtained using a temperature sensor. The temperature sensor is disposed on the surface of the ultrasonic treatment head and protrudes from the surface of the ultrasonic treatment head; and / or, there are multiple temperature sensors that are evenly distributed.

3. The method according to claim 1 or 2, characterized in that, The impedance value is acquired using an impedance sensor, which includes two electrode plates, and the impedance sensor satisfies at least one of the following: The electrode sheet is made of pure silver; The surface of the electrode sheet is coated with titanium nitride.

4. The method according to claim 1 or 2, characterized in that, Also includes: Based on the impedance value and / or the ultrasonic reflectivity, the amount of coupling agent is determined, including excessive coupling agent, insufficient coupling agent, and appropriate coupling agent. If it is determined that the amount of coupling agent used is excessive or insufficient, a corresponding prompt message will be output.

5. The method according to claim 1, characterized in that, The ultrasonic reflected wave energy is acquired using an ultrasonic reflectivity detector; the ultrasonic reflectivity detector includes an ultrasonic receiving transducer, a preamplifier, and a signal conditioning circuit; the ultrasonic receiving transducer is used to receive ultrasonic reflected waves and output electrical signals, the preamplifier is used to amplify the electrical signals output by the ultrasonic receiving transducer, and the signal conditioning circuit is used to perform subsequent processing on the electrical signals output by the preamplifier.

6. The method according to claim 5, characterized in that, The ultrasonic receiver transducer of the ultrasonic reflectivity detector is multiplexed with the ultrasonic transmitter transducer; or, the ultrasonic receiver transducer is a device independent of the ultrasonic transmitter transducer; wherein, the ultrasonic transmitter transducer is used to transmit ultrasonic incident waves. In the case where the ultrasonic receiving transducer is independent of the ultrasonic transmitting transducer, the ultrasonic transmitting transducer is disposed in the central region of the ultrasonic treatment head, the ultrasonic receiving transducer of the ultrasonic reflectivity detector is disposed at the edge of the ultrasonic treatment head, and the ultrasonic receiving surface of the ultrasonic receiving transducer and the ultrasonic transmitting surface of the ultrasonic transmitting transducer form a preset angle.

7. The method according to claim 1, characterized in that, Before issuing an alarm when one or more of the target parameter values ​​fall within the risk value range, the method further includes: The target parameter values ​​are then subjected to moving average filtering.

8. The method according to claim 1, characterized in that, One target parameter corresponds to multiple risk value ranges; When one or more of the target parameter values ​​fall within the risk value range, an alarm is triggered, including: The current risk level is determined based on the risk value range into which the target parameter value falls; the higher the risk level, the greater the risk. Execute the alarm operation corresponding to the risk level.

9. The method according to claim 8, characterized in that, The risk value range includes two different ranges, namely a first risk value range and a second risk value range, wherein the first risk value range is closer to the safe value range than the second risk value range; Determining the current risk level based on the risk value range that the target parameter value falls into includes: If the target parameter value satisfies one of the two first conditions, then the current risk level is determined to be Level 1; If the target parameter value satisfies one of the three second conditions, then the current risk level is determined to be level two; If the target parameter value satisfies one of the three third conditions, then the current risk level is determined to be level three; The two first conditions are: one of the target parameter values ​​falls within the corresponding first risk value range, and the magnitude of exceeding the safety value does not exceed the first magnitude threshold; and one of the target parameter values ​​falls within the corresponding first risk value range, and changes towards the safety value range for a continuous first preset time. The three second conditions are: two of the target parameter values ​​fall within the corresponding first risk value range; one of the target parameter values ​​falls within the corresponding first risk value range and exceeds the safety value by a second magnitude threshold; the current risk level is level one and has lasted for a second preset time. The two third conditions are: one of the target parameter values ​​falls within the corresponding range of the second risk value; the current risk level is level one and has lasted for a third preset time; the current risk level is level two and has lasted for a fourth preset time.

10. An ultrasound therapy device, characterized in that, include: An ultrasonic therapy device main unit and an ultrasonic therapy head, wherein the ultrasonic therapy head includes an ultrasonic transducer; The main unit of the ultrasound therapy device includes a memory and a processor, which are interconnected. The memory stores computer instructions, and the processor executes the computer instructions to perform the early warning method according to any one of claims 1 to 9.

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