Method and system for monitoring high intensity focused ultrasound energy output

Abstract

This disclosure relates to the field of medical device technology, providing a method and system for monitoring high-intensity focused ultrasound (HIFU) energy output. Based on acquired equipment operation information of the HIFU device, multiple preliminary monitoring results are obtained regarding whether the HIFU device is in an ultrasound energy output state. These include a first preliminary monitoring result determined based on control behavior information; a second preliminary monitoring result determined based on power supply parameter information of the power module; and at least one preliminary monitoring result based on collected environmental information affected by the HIFU energy, including a third preliminary monitoring result obtained from monitoring images of the irradiation location. A confirmatory monitoring result is then obtained by performing multi-dimensional judgment based on these multiple preliminary monitoring results to determine whether the HIFU device is in an ultrasound energy output state. Therefore, through multi-dimensional monitoring and comprehensive judgment, energy output can be verified in real time and accurately, improving treatment safety and effectiveness.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to a method and system for monitoring the energy output of high-intensity focused ultrasound. Background Technology

[0002] In high-intensity focused ultrasound (HIFU) treatment, the key to effective treatment lies in the precise control of ultrasound energy output. However, due to the influence of equipment parameters, amplifier status, and external factors, the actual output ultrasound energy may deviate from the commanded setting, potentially leading to poor treatment results or insufficient ultrasound focus. Traditional methods rely solely on feedback from the focused ultrasound equipment, lacking reliable means to verify the actual energy output in real time and accurately. Summary of the Invention

[0003] In view of the shortcomings of the prior art described above, the purpose of this disclosure is to provide a method and system for monitoring high-intensity focused ultrasound energy output, and to solve the problems in the related art.

[0004] This disclosure provides a method for monitoring high-intensity focused ultrasound (HIFU) energy output. The HIFU energy is output from a focused ultrasound device, which includes: an energy amplification module that outputs an ultrasonic excitation signal to an ultrasonic transducer for generating HIFU energy output; a power supply module that supplies power to the energy amplification module; and a control unit that controls the energy amplification module to generate the ultrasonic excitation signal output. The method includes: acquiring power amplifier control behavior information of the control unit and determining a first preliminary monitoring result based on the control behavior information whether the focused ultrasound device is in an ultrasonic energy output state; acquiring power supply parameter information of the power supply module and determining a second preliminary monitoring result based on the power supply parameter information whether the focused ultrasound device is in an ultrasonic energy output state; identifying a monitoring image containing the irradiation location of the HIFU energy to determine whether the focused ultrasound device is in an ultrasonic energy output state; and determining a confirmation monitoring result based on the consistency of multiple preliminary monitoring results acquired simultaneously to determine whether the focused ultrasound device is in a normal ultrasonic energy output state.

[0005] In an embodiment of the first aspect, the first preliminary monitoring result of acquiring the power amplifier control behavior information of the control unit and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the control behavior information includes: acquiring an activation notification signal and a stop notification signal of the control unit; wherein the control unit generates and sends the activation notification signal when it outputs a first control command to activate the power amplifier energy output of the power amplifier circuit; and the control unit, in response to satisfying a preset output stop condition, outputs a second control command to stop the power amplifier energy output of the power amplifier circuit, and generates and sends the stop notification signal; the preset output stop condition includes at least one of: timer expiration established in conjunction with the first control command, accumulated energy reaching a target, or external command triggering.

[0006] In an embodiment of the first aspect, the method includes: determining, based on a consistency assessment of multiple preliminary monitoring results within the same time window, whether the focused ultrasound device is in a normal ultrasound energy output state by a confirmation monitoring result.

[0007] In an embodiment of the first aspect, the step of acquiring the power supply parameter information of the power module and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information includes: acquiring the first output power information of the energy amplification module; determining the operating state of the energy amplification module based on the first output power information; and determining the second preliminary monitoring result based on the power supply state.

[0008] In an embodiment of the first aspect, the third preliminary monitoring result, which is determined by identifying the location of the irradiation containing the high-intensity focused ultrasound energy based on the acquired monitoring image, includes: acquiring the monitoring image; acquiring image feature difference information of the target region between the preceding and following monitoring images; the image features include at least one of brightness, texture, contrast, edge features, or feature vectors extracted based on a feature extraction model; and determining whether an irradiation event of ultrasound energy irradiation has occurred in the target region based on the image feature difference information, to obtain the third preliminary monitoring result.

[0009] In an embodiment of the first aspect, the confirmation monitoring result for determining whether the focused ultrasound device is in a normal ultrasound energy output state based on the consistency judgment of multiple preliminary monitoring results acquired simultaneously includes: in response to multiple preliminary monitoring results being consistent, determining the consistent result as the confirmation monitoring result; in response to the first preliminary monitoring result, the second preliminary monitoring result, and the third preliminary monitoring result not being completely consistent, executing one of the following arbitration logic: 1) determining the majority of consistent results among the first preliminary monitoring result, the second preliminary monitoring result, and the third preliminary monitoring result as the confirmation monitoring result; 2) determining whether the first preliminary monitoring result and the second preliminary monitoring result are consistent; if consistent, determining the consistent result as the confirmation monitoring result; if inconsistent, further determining whether the third preliminary monitoring result meets the preset image validity conditions; if the validity conditions are met, determining the third preliminary monitoring result as the confirmation monitoring result; if the third preliminary monitoring result does not meet the validity conditions, determining that the energy output is abnormal and triggering safety protection logic; 3) obtaining a weighted sum score for each group of preliminary monitoring results based on the preset weight of each preliminary monitoring result, and determining the group of preliminary monitoring results with the higher weighted sum score as the confirmation monitoring result.

[0010] In an embodiment of the first aspect, the high-intensity focused ultrasound energy output monitoring method further includes: in response to determining an abnormal energy output event based on the confirmed monitoring result, controlling the energy output of the focused ultrasound device to eliminate the abnormal event, including: stopping the output of the power module and / or power amplifier circuit through the control unit.

[0011] A second aspect of this disclosure provides a computer device comprising: a communicator, a processor, and a memory; the communicator being communicatively connected to a focused ultrasound device; the memory storing a computer program or instructions; and the processor being configured to run the computer program or instructions to perform a high-intensity focused ultrasound energy output monitoring method as described in any one aspect of the first disclosure.

[0012] This disclosure provides a high-intensity focused ultrasound (HIFU) energy output monitoring system, comprising: an image acquisition device configured to acquire a monitoring image of a target area irradiated by high-intensity focused ultrasound energy output from a focused ultrasound device; a monitoring module configured to acquire device operation information output by the focused ultrasound device; and a computer device as described in the second aspect, communicatively connected to the image acquisition device and the monitoring module, for obtaining multiple preliminary monitoring results regarding whether the focused ultrasound device is in an ultrasound energy output state based on the device operation information acquired from the focused ultrasound device, including: acquiring power amplifier control behavior information of the control unit, and determining a first preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasound energy output state based on the control behavior information; acquiring the power amplifier control behavior information of the control unit; and acquiring the power amplifier control behavior information of the control unit. The computer device is used to obtain at least one preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information of the source module and the second preliminary monitoring result based on the power supply parameter information; the computer device is used to obtain at least one preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the environmental information collected that is affected by the focused ultrasound energy, including: a third preliminary monitoring result based on the acquisition of a monitoring image containing the irradiation location of the high-intensity focused ultrasound energy and identification to determine whether the focused ultrasound device is in an ultrasonic energy output state; and the computer device is also used to determine a confirming monitoring result regarding whether the focused ultrasound device is in a normal ultrasonic energy output state based on the consistency judgment of multiple preliminary monitoring results acquired at the same time.

[0013] In a third aspect embodiment, the computer device is further configured to control the output of the focused ultrasound device to eliminate the abnormal event in response to determining an abnormal energy output event based on the confirmed monitoring results.

[0014] As described above, this disclosure relates to the field of medical device technology, providing a method and system for monitoring high-intensity focused ultrasound (HIFU) energy output. Based on acquired equipment operation information of the HIFU device, multiple preliminary monitoring results are obtained regarding whether the HIFU device is in an ultrasound energy output state. These include a first preliminary monitoring result determined based on control behavior information; a second preliminary monitoring result determined based on power supply parameter information of the power module; and at least one preliminary monitoring result based on collected environmental information affected by the HIFU energy, including a third preliminary monitoring result obtained based on monitoring images of the irradiation location. A confirmatory monitoring result is then obtained by performing multi-dimensional judgment based on these multiple preliminary monitoring results to determine whether the HIFU device is in an ultrasound energy output state. Therefore, through multi-dimensional monitoring and comprehensive judgment, energy output can be verified in real time and accurately, improving treatment safety and effectiveness. Attached Figure Description

[0015] Figure 1A schematic diagram of the circuit system of a focused ultrasound device according to an embodiment of the present disclosure is shown.

[0016] Figure 2 A schematic diagram illustrating the application of a high-intensity focused ultrasound energy output monitoring system in one embodiment of this disclosure is shown.

[0017] Figure 3 A flowchart illustrating a high-intensity focused ultrasound energy output monitoring method according to an embodiment of this disclosure is shown.

[0018] Figure 4 A schematic diagram of a high-intensity focused ultrasound energy output monitoring device is shown in one embodiment of the present disclosure.

[0019] Figure 5 A schematic diagram of the structure of a computer device according to an embodiment of the present disclosure is shown. Detailed Implementation

[0020] The following specific examples illustrate the implementation of this disclosure. Those skilled in the art can easily understand other advantages and effects of this disclosure from the information disclosed herein. This disclosure can also be implemented or applied through other different specific embodiments, and various details in this disclosure can be modified or changed according to different viewpoints and application modules without departing from the spirit of this disclosure. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of this disclosure can be combined with each other.

[0021] The embodiments of this disclosure will now be described in detail with reference to the accompanying drawings, so that those skilled in the art to which this disclosure pertains can readily implement it. This disclosure may be embodied in many different forms and is not limited to the embodiments described herein.

[0022] In this disclosure, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic represented in connection with that embodiment or example is included in at least one embodiment or example of this disclosure. Furthermore, the specific features, structures, materials, or characteristics represented may be combined in any suitable manner in any one or a group of embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples represented in this disclosure, as well as the features of those different embodiments or examples.

[0023] Furthermore, the terms "first" and "second" are used for illustrative 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 at least one of that feature. In the representation of this disclosure, "a set" means two or more, unless otherwise explicitly specified.

[0024] For the purpose of clarity, devices unrelated to the description are omitted, and the same or similar components throughout the specification are given the same reference numerals.

[0025] Throughout this specification, when it is said that a device is "connected" to another device, this includes not only "direct connection" but also "indirect connection" by placing other components in between. Furthermore, when it is said that a device "comprises" a certain constituent element, unless otherwise stated otherwise, this does not exclude other constituent elements, but rather implies that other constituent elements may be included.

[0026] While the terms first, second, etc., are used in some examples herein to refer to various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, first interface and second interface, etc., are used. Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to also include the plural forms unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” indicate the presence of the stated feature, step, operation, element, module, item, kind, and / or group, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, modules, items, kinds, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition will only occur if the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0027] The technical terms used herein are for reference only to specific embodiments and are not intended to limit the scope of this disclosure. The singular form used herein includes the plural form unless the statement explicitly indicates otherwise. The word "comprising" as used in this specification means to specify a particular characteristic, region, integer, step, operation, element, and / or component, and does not exclude the presence or addition of other characteristics, regions, integers, steps, operations, elements, and / or components.

[0028] Although not explicitly defined, all terms, including technical and scientific terms used herein, shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Terms defined in commonly used dictionaries shall be further interpreted as having a meaning consistent with the relevant technical literature and the message of the present disclosure, and shall not be over-interpreted as having an ideal or overly formulaic meaning unless otherwise defined.

[0029] In high-intensity focused ultrasound (HIFU) treatment, the key to effective treatment lies in the precise control of ultrasound energy output. However, due to the influence of equipment parameters, amplifier status, and external factors, the actual output ultrasound energy may deviate from the commanded setting, potentially leading to poor treatment results or insufficient ultrasound focus. Traditional methods rely solely on feedback from the focused ultrasound equipment, lacking reliable means to verify the actual energy output in real time and accurately.

[0030] Therefore, this disclosure provides a high-intensity focused ultrasound energy output monitoring method, which monitors and judges the monitoring results of multiple information dimensions related to the energy of the focused ultrasound device to obtain the final monitoring result of whether the focused ultrasound device actually outputs energy.

[0031] Focused ultrasound (FUS) is a technique that focuses ultrasound waves onto a specific target area to achieve therapeutic functions (such as tumor ablation, neuromodulation, etc.) or imaging. FUS uses a high-intensity ultrasound beam to precisely focus on a specific target area (such as a tumor or lesion tissue) within the body, converting acoustic energy into heat energy or other biological effects to achieve therapeutic goals. This technology combines the advantages of image guidance, precise localization, and localized treatment. The advantages of FUS include: non-invasiveness, high precision, high repeatability, and minimal side effects. Major application areas include: tumor treatment, cosmetic and rehabilitation, neurological diseases, and other applications. For example, tumor treatment includes, but is not limited to, solid tumors such as uterine fibroids, liver cancer, breast cancer, prostate cancer, and pancreatic cancer. Cosmetic and rehabilitation applications include, but are not limited to: anti-aging and skin tightening (thermal effects cause collagen fibers to contract and initiate repair mechanisms, stimulating the synthesis of new collagen), fat ablation (mechanical effects destroy fat cell membranes), and non-invasive body sculpting. Other applications include, but are not limited to: essential tremor, osteoarthritis, and pain management.

[0032] Please see Figure 1 The diagram shown illustrates the structure of the circuit system of a focused ultrasound device according to an embodiment of the present disclosure.

[0033] The focused ultrasound device 100 includes an ultrasonic transducer 110, a power module 120, an ultrasonic drive circuit 130, and a control module 140.

[0034] In some embodiments, the focused ultrasound device 100 may have a treatment head on which the ultrasound transducer 110 is mounted. The treatment head may be attached to a moving mechanism for being moved. The ultrasound transducer 110 is responsive to an ultrasound excitation signal to generate a focused ultrasound output to irradiate a focal point. In some embodiments, the ultrasound transducer 110 includes a plurality of transducers. The transducers may be implemented as piezoelectric crystal elements (such as piezoelectric ceramics or composite materials) that convert electrical energy into ultrasonic energy generated by mechanical vibration. One or more of the transducers may form one or more array elements. In an alternative embodiment, the ultrasound transducer 110 may be implemented as a self-focusing ultrasound transducer, preferably a multi-phased ultrasound transducer. A self-focusing ultrasound transducer includes one or more array elements. A multi-phased ultrasound transducer may include tens to hundreds of array elements, and the emission time of the ultrasound waves from the plurality of array elements can be controlled by pulse signals with different delay times to change the phase relationship when the ultrasound waves arrive at (or originate from) a point within an object, thereby achieving directional changes and focusing of the ultrasound waves. For example, by adjusting the emission delay (i.e., corresponding phase) of different array elements, the ultrasonic waves emitted by different elements can all reach a peak or trough at a set position, thus creating a focal point at that position. Multi-channel phased-array ultrasonic transducers achieve focal point movement of focused ultrasound through electronic phase control, enabling better focus adjustment flexibility. Using phased-array ultrasonic transducers eliminates the need for mechanical structures to move the treatment head when the focused ultrasound focal point changes, effectively improving treatment efficiency, reducing damage to the target object, and increasing safety.

[0035] The power supply module 120 can be used to output power signals with electrical parameters suitable for each treatment mode. These electrical parameters include, but are not limited to, voltage, current, or power. In some embodiments, the power supply module 120 can be used to output power signals suitable for one or more focused ultrasound treatment modes. For example, the one or more focused ultrasound treatment modes can be selected from thermal effect modes (such as thermal ablation modes or other heating modes) or tissue destruction modes.

[0036] In some embodiments, the power module 120 may include at least one power supply device with an adjustable output voltage, and the power module 120 may be communicatively connected to the control module 140 to be controlled by the power signal output therefrom. In some embodiments, the power module 120 may be a programmable power supply or a programmable DC power supply with voltage regulation function. In other embodiments, it may also be implemented using a common switching power supply circuit or a customized power supply circuit combined with a voltage regulation circuit. Depending on the circuit implementation, the power module 120 may be controlled by analog signals or digital signals. As an example, the voltage regulation circuit may be implemented as a DC voltage regulator circuit, which can achieve different intensity sound pressure outputs through voltage regulation. In one example, the voltage regulation signal may be implemented as an analog signal, such as a continuously varying voltage or current signal, with different signal values ​​mapping different output voltages. In another embodiment, the voltage regulation signal may be implemented as a discrete level signal, such as PWM, I²C, SPI, GPIO, etc. Accordingly, the power module 120 needs to provide an analog signal control interface and / or a digital signal control interface.

[0037] In some embodiments, the power module 120 may be converted by a power conversion circuit to obtain a supply voltage suitable for the operating voltage range of the control module 140, so as to supply power to the control module 140. Alternatively, in other embodiments, the power module 120 may be used only to supply power to the ultrasonic drive circuit 130, and the control module 140 may be independently powered by another power supply (and a power circuit capable of converting to a suitable supply voltage).

[0038] The ultrasound drive circuit 130 is coupled to the control module 140 and the power supply module 120, allowing the controlled drive of the treatment head to output focused ultrasound in one or more treatment modes. For example, in the thermal effect mode for achieving thermal ablation, the ultrasound excitation signal needs to have a relatively moderate voltage amplitude and a relatively high duty cycle. In the tissue destruction mode, the ultrasound excitation signal may be a pulse signal with a highly variable voltage amplitude and an extremely low duty cycle.

[0039] The ultrasonic drive circuit 130 may include a signal generation circuit 131 and a power amplifier circuit 132. The signal generation circuit 131 is connected to the control module 140 and the power amplifier circuit 132, and is controlled by the control module 140 to output an ultrasonic excitation signal with signal parameters matched to the selected treatment mode to the power amplifier circuit 132. The power amplifier circuit 132 is also connected to the power supply module 120, and is used to amplify the ultrasonic excitation signal based on the energy of the power supply signal output by the power supply module 120 to generate an ultrasonic excitation signal. The power amplifier circuit 132 is also connected to the ultrasonic transducer 110 to output the ultrasonic excitation signal to excite the ultrasonic transducer 110 to output ultrasonic energy. Therefore, the power supply signal provides the energy for amplifying the ultrasonic excitation signal, which includes the signal parameters of the generated focused ultrasound, including, for example, frequency and duty cycle. Ultrasonic excitation signals with matching signal parameters can be output for different treatment modes.

[0040] In some embodiments, the signal parameters can be externally input to the control module 140, for example, from user input via a human-machine interface. The control module 140, according to instructions, commands the signal generation circuit 131 to generate a corresponding ultrasonic excitation signal based on the signal parameters. In some embodiments, the signal generation circuit 131 can be implemented using a processor (such as an MCU, DSP, etc.) combined with a direct digital frequency synthesis (DDS) circuit or other frequency generation circuit.

[0041] As previously described, the power amplifier circuit 132 uses the power supply signal output from the power module 120 to amplify the ultrasonic excitation signal, forming an ultrasonic excitation signal that is output to the ultrasonic transducer 110 to excite ultrasonic output and focus. Therefore, the intensity of the focused ultrasound output by the ultrasonic transducer 110 is determined by the amplitude of the power supply signal, and the duty cycle, frequency, etc. of the focused ultrasound signal are determined by the ultrasonic excitation signal.

[0042] In some embodiments, the power amplifier circuit 132 can be implemented as a power amplifier circuit. The power amplifier circuit 132 can be implemented based on a half-bridge or full-bridge amplifier architecture, or it can be implemented through, for example, an LC resonant amplifier circuit. In optional embodiments, the power amplifier circuit 132 can operate over a wide voltage range (e.g., 0~100V, or 10V~1000V, etc.), therefore, its corresponding components should be selected based on models and specifications capable of withstanding higher voltages. For example, capacitors, resistors, inductors, MOFETs / SiCMOSFETs, gate drivers, diodes, etc., can be selected as voltage-resistant components with a withstand voltage at least one to several times the highest operating voltage of the circuit.

[0043] Of course, the structure of the ultrasonic drive circuit 130 is not limited to this, so the signal generation circuit 131 and the power amplifier circuit 132 are represented by dashed lines. In some embodiments, the signal generation circuit 131 and the power amplifier circuit 132 can be changed according to functional requirements. For example, if the signal generation circuit 131 is replaced by the control module 140, then the ultrasonic drive circuit 130 may include the power amplifier circuit 132, but does not necessarily need to include the signal generation circuit 131.

[0044] In some embodiments, the control module 140 may be implemented as an embedded controller including an embedded processor such as a microcontroller unit (MCU), a system-on-a-chip (SOC), or a programmable logic array (FPGA), and communicates with external devices to receive relevant instructions sent by external devices to control the operation of the circuit system, such as adjusting the signal output of the power supply module 120 and the signal generation circuit to the power amplifier circuit.

[0045] like Figure 2 The diagram illustrates the application of a high-intensity focused ultrasound energy output monitoring system in one embodiment of this disclosure.

[0046] exist Figure 2 The image illustrates a high-intensity focused ultrasound (HIFU) energy output monitoring system used to monitor the ultrasonic energy output status of a focused ultrasound device 100. The HIFU energy output monitoring system includes a monitoring module 200 and a computer device 300. The computer device 300 can be implemented as an external device (such as a host computer) communicating with the focused ultrasound device 100, or as a control module 140 within the focused ultrasound device 100.

[0047] The monitoring module 200 is configured to acquire device operation information output by the focused ultrasound device 100. In some embodiments, the device operation information is electrical parameter information related to changes in the ultrasound energy output state.

[0048] As an example, the device operation information may include information on the power amplifier control behavior of the control module 140 in the focused ultrasound device 100 over the power module 120. For example, the control module 140 may use control commands in the form of analog or digital signals to control the power signal output of the power module 120.

[0049] It should be noted that the ultrasound energy output of the focused ultrasound device 100 is according to the treatment plan. The treatment plan outlines the movement trajectory of each irradiation point of the ultrasound energy. The process of the focused ultrasound completing the treatment plan involves outputting ultrasound energy to each irradiation point along the movement trajectory. Therefore, the focused ultrasound device 100 will periodically perform one focused ultrasound irradiation event at each irradiation point, consisting of starting energy output, maintaining energy output, and stopping energy output. Correspondingly, the control module 140 controls the power supply module 120 to turn on the power signal output, maintain the power signal output, and turn off the power signal output to the power amplifier circuit, so that the power amplifier circuit is in the corresponding start-up, energy output, and stop output states. Therefore, the monitoring module 200 can monitor the power amplifier control behavior information of the control module 140 to the power supply module 120 to determine the first preliminary monitoring result of whether the focused ultrasound device 100 is in the ultrasound energy output state.

[0050] As one implementation example, the monitoring module 200's function of monitoring the power amplifier control behavior information of the control module 140 can be implemented within the control module 140. Utilizing the embedded feedback mechanism of the control module 140, the operating status and parameters of the power amplifier circuit are monitored. By acquiring command signals and execution feedback signals from the power amplifier circuit, it analyzes in real time whether the power amplifier strictly follows the commands. Optionally, the embedded control module 140 can also provide a multi-parameter configurable interface for setting different power amplifier monitoring characteristics, enabling flexible monitoring of different power amplifier parameters. Alternatively, in another implementation example, it can be implemented by a monitoring circuit that monitors the signal output of the control module 140.

[0051] In some examples, the computer device 300 can be implemented as an external device. When the control module 140 receives an execution command from the external device, the control module 140 can set a preset device status item to the power amplifier on state. Optionally, a timer for energy output time and interval time can be set according to the parameters in the execution command for controlling the duration of a single power amplifier energy output. While the control module 140 enables the power amplifier energy output of the power amplifier circuit, it can send an on notification signal to the external device. Optionally, while the control module 140 enables the power amplifier energy output of the power amplifier circuit, it can start the timer. When the timer expires, it triggers a signal indicating the completion of a single power amplifier energy output, shuts down the power amplifier energy output, starts the interval timer, and sends a power amplifier stop notification signal to the host computer. Corresponding to the treatment plan, the above energy output start / stop operations are executed cyclically until the treatment plan is completed. Furthermore, for reliability considerations and to avoid message loss, after sending an on notification signal or a power amplifier power output off signal to an external device, if the control module 140 does not receive a reply signal from the external device within a certain period, it will send the on or off signal again until a reply signal is received. The on or off signal is used to indirectly infer whether the power amplifier circuit is in the power output state, and correspondingly, whether the ultrasonic transducer is in the ultrasonic energy output state. If no reply signal is received for an extended period exceeding a time threshold, an abnormal event in the focused ultrasound device 100 can be identified. The external device can then control the operation of the focused ultrasound device 100 to eliminate the abnormal event, such as stopping operation.

[0052] Therefore, the power amplifier control behavior information can be implemented as each pair of the start notification signal and stop notification signal. Ideally, the start notification signal and the absence of a stop notification signal can be used to indirectly determine whether the device is in an energy output state, and the stop notification signal and the absence of a start notification signal can be used to determine whether the device is not in an energy output state. Thus, a first preliminary monitoring result on whether the focused ultrasound device 100 is in an ultrasonic energy output state can be indirectly inferred.

[0053] In other examples, the computer device 300 may be implemented as the control module 140. The control module 140 may determine the first preliminary monitoring result based on the transmission of a first control command and a second control command.

[0054] In some embodiments, the monitoring module 200 may include a sampling circuit module 210 disposed within the focused ultrasound device 100 to collect power supply parameter information of the power supply module 120, including a current and / or voltage sampling circuit. The current and / or voltage sampling circuit calculates the output power of the power supply module 120 to determine its power supply status, thereby indirectly inferring whether the power amplifier circuit is in an energy output state, and correspondingly inferring whether the ultrasonic transducer is in an ultrasonic energy output state. As an example, its power supply status can be determined based on whether the first output power information of the power supply module 120 is higher than a preset threshold (e.g., standby power). Thus, a second preliminary monitoring result can be indirectly inferred as whether the focused ultrasound device 100 is in an ultrasonic energy output state. Specifically, this embodiment can identify the start and end of a focused ultrasound irradiation event by analyzing the real-time output power. The specific steps are as follows: First, the output voltage and output current are collected in real-time by the high-frequency sampling module on the power amplifier power supply, and the real-time output power (output voltage value multiplied by output current value) is calculated according to the power calculation formula. Second, to detect the start of irradiation, the real-time output power is compared with the maximum standby power. When the real-time output power exceeds the maximum standby power, the system considers the current state as the beginning of an irradiation event. Finally, to determine the end of the event, the real-time output power is compared with the standby power threshold. When the real-time output power does not exceed the standby power threshold, the system considers the current state as the end of the irradiation event. Through this complete process, the duration of a high-energy irradiation process can be automatically detected and recorded.

[0055] In some embodiments, the monitoring module 200 may include an image acquisition device 220, such as a camera. The image acquisition device 220 is configured to acquire monitoring images of the location irradiated by the ultrasonic energy output from the focused ultrasound device 100. In these monitoring images, the brightness of the irradiated location when exposed to ultrasonic energy is significantly higher than the brightness when not exposed to ultrasonic energy. Therefore, based on the change in brightness at the irradiated location in the image, the presence or absence of ultrasonic energy irradiation can be directly determined. Thus, a preliminary third monitoring result indicating whether the focused ultrasound device 100 is in an energy output state can be directly obtained.

[0056] It is understandable that the first preliminary monitoring result and the second preliminary monitoring result correspond to the "indirect" determination of whether the focused ultrasound device 100 has energy output based on the power amplifier control behavior information of the control module 140 and the output of the power module 120, respectively. However, in reality, due to fault problems, the command issued by the control module 140 to control the power amplifier behavior may not cause the power module 120 to achieve the corresponding power output or shutdown (if a fault occurs), or even if the power module 120 achieves the corresponding power output or shutdown output, it may not cause the power amplifier circuit (if a fault occurs) to achieve the corresponding energy output or shutdown.

[0057] Therefore, some contradictory preliminary monitoring results may occur, namely, "the mere presence of control commands does not necessarily mean that ultrasonic energy output or no output actually occurs."

[0058] For example, the control module 140 outputs a first control command to the power module 120 to turn on the power supply, and the first preliminary monitoring result is "energy output". However, if the power module 120 does not actually output power due to delay, fault, or other reasons, the second preliminary monitoring result is "no energy output". If the power amplifier circuit does not receive power and has no energy output, the third preliminary monitoring result is "no energy output".

[0059] Alternatively, the control module 140 outputs a second control command to the power module 120 to shut down the power supply, and the first preliminary monitoring result is "no energy output". However, due to a delay, the power module 120 does not shut down in time, so the second preliminary monitoring result is "energy output". The power amplifier circuit is also still in the energy output state, so the third preliminary monitoring result is "energy output".

[0060] When there are contradictions among the preliminary monitoring results, it is necessary to make a comprehensive judgment based on the preliminary monitoring results through arbitration logic to obtain a confirmed monitoring result, so as to accurately determine whether the focused ultrasound device 100 is currently in an energy output state.

[0061] Based on the above principle, the computer device 300 executes a high-intensity focused ultrasound energy output monitoring method to obtain preliminary monitoring results by collecting information from multiple dimensions related to the ultrasound energy output of the focused ultrasound device 100 (such as device operation information, environmental information, etc.) and then comprehensively obtaining accurate confirmation monitoring results.

[0062] like Figure 3 The diagram shown illustrates a flowchart of a high-intensity focused ultrasound energy output monitoring method according to an embodiment of this disclosure.

[0063] exist Figure 3 The methods include:

[0064] Step S301: Based on the equipment operation information obtained from the focused ultrasound device, obtain multiple preliminary monitoring results regarding whether the focused ultrasound device is in an ultrasonic energy output state.

[0065] Specifically, by acquiring the power amplifier control behavior information of the control unit, and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the control behavior information, a first preliminary monitoring result is obtained.

[0066] In some embodiments, the control unit generates and sends the start-up notification signal to the computer device when it outputs a first control command to enable the power amplifier circuit's power output. The control unit may also, in response to a preset output stop condition, output a second control command to stop the power amplifier circuit's power output and generate and send a stop notification signal to the computer device. This completes one focused ultrasound irradiation session. A focused ultrasound irradiation event can then be determined based on a pair of start-up and stop notification signals. Therefore, the first preliminary monitoring result can be determined based on the start-up and stop notification signals.

[0067] In some embodiments, the preset output stop condition can be obtained based on the expiration of the timer. However, this is not a limitation.

[0068] In other embodiments, the preset output stop condition may include whether the accumulated output energy of the power module (or power amplifier circuit) meets a certain threshold. As an example, this can be achieved by acquiring the output power of the power module (or power amplifier circuit), for instance, through... Figure 2 The sampling circuit module 210 collects data and performs time-integration calculations to obtain the cumulative output energy. Comparing the cumulative output energy with a preset energy threshold determines whether the target has been met.

[0069] In some embodiments, the preset output stop condition may include being triggered by an external input command, such as a user-input stop output command.

[0070] Specifically, the second preliminary monitoring result is obtained by acquiring the power supply parameter information of the power module and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information.

[0071] In some embodiments, the computer device may acquire first output power information of the power module, such as by sampling current and voltage through the monitoring module to calculate the output power of the power module. Further, the computer device determines the power supply state of the power module (e.g., standby state or power output state) based on the first output power information, and determines the second preliminary monitoring result based on the power supply state. As an example, a standby power threshold / range can be preset, and the first output power information can be compared with the standby power threshold / range. If the output power of the power module indicated by the first output power information is higher than the standby power threshold / range, then an "energy output state" can be determined; otherwise, an "energy not output state" can be determined. Thus, the second preliminary monitoring result can be obtained.

[0072] For example, the device operation information may also include other types of information, such as second output power information corresponding to the output power of the power amplifier circuit of the focused ultrasound device. It is understood that the second output power information is used to determine a fourth preliminary monitoring result as to whether the focused ultrasound device is in an ultrasonic energy output state. For example, the second output power information can be compared with a preset power amplifier standby power threshold; if it is higher than the preset power amplifier standby power threshold, it is determined to be in an energy output state; if it is lower than the preset power amplifier standby power threshold, it is determined to be in an energy-not-output state.

[0073] Step S302: Based on the environmental information collected that is affected by the focused ultrasound energy, at least one preliminary monitoring result is obtained regarding whether the focused ultrasound device is in an ultrasound energy output state.

[0074] Specifically, based on the monitoring image of the irradiation location containing the high-intensity focused ultrasound energy, a third preliminary monitoring result is obtained to determine whether the focused ultrasound device is in an ultrasound energy output state.

[0075] In some embodiments, the computer device may acquire the monitoring image through a connected image acquisition device. The monitoring image may be a grayscale image, or a non-grayscale monitoring image may be converted to a grayscale image. Then, image feature difference information of the target region between the preceding and following monitoring images is acquired, and based on the image feature difference information, it is determined whether the target region has experienced an irradiation event caused by ultrasonic energy, to obtain the third preliminary monitoring result. The image features include at least one of brightness, texture, contrast, edge features, or feature vectors extracted based on a feature extraction model.

[0076] The brightness of the monitoring images changes before and after ultrasonic energy output. Specifically, the intensity of the ultrasonic echo determines the pixel brightness. After energy input, the tissue absorbs the acoustic energy, causing local heating, denaturation, coagulation, and necrosis, resulting in changes in density and elasticity. This leads to changes in acoustic impedance differences, thereby enhancing or weakening the echo. For example, the thermal ablation area reflects ultrasound more strongly, making that area brighter on the image. The cavitation area reflects weaker echoes, making it darker. Simply put, the target pixel block corresponding to the ultrasonic irradiation location shows a gradual change in brightness between the current and subsequent monitoring images. For example, increased brightness may correspond to the ultrasonic energy output state; decreased brightness corresponds to the ultrasonic energy output being turned off, or a state where no energy is output. This allows us to obtain the aforementioned third preliminary monitoring result.

[0077] Tissue texture may change in monitoring images before and after ultrasound energy output. Specifically, after energy input, cell structure is damaged, tissue remodeling occurs, necrotic areas appear, hemorrhage occurs, edema occurs, etc., and the microstructure becomes disordered or presents a new pattern. For example, the originally smooth / regular texture becomes rough, uneven, with increased granularity, or the structure disappears.

[0078] The contrast in monitoring images changes before and after ultrasound energy output. Specifically, contrast refers to the degree of difference in brightness between different areas. Energy input may cause differences in the acoustic properties of the target area and normal tissue.

[0079] The edge features of the target area may change in monitoring images before and after ultrasound energy output. The tissue at the edge of the target area may show significant changes at the interface with the surrounding tissue due to thermal ablation or cavitation. The tissue structure at the interface is destroyed or fused, and the originally clear edge becomes blurred and its continuity deteriorates. For example, the original edge may be weakened or broken, or a new, steeper edge contour may appear.

[0080] For feature extraction models (such as deep learning models like CNNs or other types of models), the abstract representation learned from an image is presented as the feature vector, which is essentially the encoding result of information in the image that can represent image features, such as texture, shape, and brightness distribution. When energy input changes the distribution of the image, that is, the image features change, the corresponding feature vector also changes.

[0081] In some embodiments, among the various image features mentioned above, one can be selected for difference comparison between the preceding and following frames. If the difference exceeds a preset threshold, a change in ultrasound energy output is determined. Alternatively, multiple image features can be selected for difference comparison, and a fused difference can be obtained by performing linear regression (e.g., weighted fusion) on the differences of each image feature. The final third preliminary monitoring result is then obtained based on the fused difference. In some embodiments, when fusing the differences of multiple image features, the differences can be differential values, which can be normalized to between 0 and 1 for fusion; or, the difference rate of multiple image features between the preceding and following frames can be used for direct fusion. In some other embodiments, labels indicating whether there is actual energy output can be added based on the differences of multiple image features in the preceding and following frames to form each training data point. A machine learning model is then trained to obtain an energy output discrimination model, which is used to obtain the third preliminary monitoring result output based on the differences of multiple image features in the input preceding and following frames to be compared.

[0082] In some embodiments, the position of the target pixel block to be compared for image feature differences in the monitoring images of the preceding and following frames can be determined by an image recognition algorithm or by specifying a coordinate position in the image coordinate system.

[0083] In one example, the ultrasound irradiation location can be predetermined according to the treatment plan. The ultrasound irradiation location can be pre-marked with a specific pattern; the corresponding target pixel block can be obtained by identifying the specific pattern marker in the monitoring image using an image recognition algorithm. The image recognition algorithm can be a feature point recognition algorithm, including but not limited to scale-invariant feature transform (SIFT), histogram of oriented gradients (HOG), local binary pattern (LBP), edge detection, and neural network models (various feature recognition models based on CNN or its variants).

[0084] In another example, since the image acquisition device may include one or more cameras with defined locations, the coordinate transformation relationship between the image coordinate system of the acquired image to be detected and the external spatial coordinate system can be pre-calibrated. The field of view of the image acquisition device can cover each ultrasound irradiation location involved in the treatment plan. Based on the treatment plan, the spatial coordinates of the ultrasound irradiation locations in the spatial coordinate system can also be pre-determined. Therefore, according to the coordinate transformation relationship and the spatial coordinates of the ultrasound irradiation locations, the target image coordinates of each ultrasound irradiation location in the image coordinate system can be determined to obtain the target pixel block in the image to be detected.

[0085] In some embodiments, the monitoring images of the preceding and following frames can be adjacent frames or non-adjacent frames, depending on whether the acquisition frequency of the image acquisition device is sufficient to produce obvious changes in image features that can identify changes in ultrasonic energy between adjacent monitoring images (such as a brightness difference exceeding a preset brightness difference threshold). If sufficient, adjacent monitoring images can be used; otherwise, monitoring images of the preceding and following frames with an interval of n frames can be selected according to the required preset brightness difference threshold, where n≥1.

[0086] In some embodiments, multiple frames can be selected from the preceding and following monitoring images to form two sets of monitoring images. The average features (e.g., average brightness) of the preceding set of monitoring images are calculated to obtain the preceding comparison monitoring image, and the average features of the following set of monitoring images are calculated to obtain the following comparison monitoring image. The third preliminary monitoring result is obtained by comparing the average features of the ultrasonic irradiation location between the preceding and following comparison monitoring images. Using the average feature results of multiple monitoring images for comparison, compared to comparing a single frame of monitoring images, can eliminate abrupt interference and improve the reliability of the judgment.

[0087] For example, the environmental information may also include other types of information, such as temperature information of the focused ultrasound device, including but not limited to the temperature information of at least one of the power supply module, power amplifier circuit, etc.; or, it may be the temperature information of the irradiation location. Then, the monitoring module includes a temperature sensor located at the corresponding position for collecting the temperature information. It is understood that the fifth preliminary monitoring result is to determine whether the focused ultrasound device is in an ultrasonic energy output state based on the temperature information. For example, the temperature information may include temperature. The temperature value included in the temperature information is compared with a preset temperature threshold / preset temperature range; if it is higher, it can be determined that it is in an energy output state; if it is lower, it can be determined that it is in an energy-not-output state.

[0088] It is worth mentioning that steps S301 and S302 can be executed in any order. Optionally, the collection of equipment operation information and environmental information in steps S301 and S302 can be performed in real time, and corresponding preliminary monitoring results can be obtained in real time.

[0089] Step S303: Based on the consistency judgment of multiple preliminary monitoring results acquired at the same time, determine the confirmation monitoring result of whether the focused ultrasound device is in a normal ultrasound energy output state.

[0090] In some embodiments, if multiple preliminary monitoring results are consistent, the consistent result is determined as the confirmed monitoring result. For example, if the first, second, and third preliminary monitoring results all show a consistent "energy output status," then the confirmed monitoring result is "energy output status." Of course, the same result applies when other preliminary monitoring results (such as the fourth and fifth preliminary monitoring results) are added.

[0091] In some embodiments, if multiple preliminary monitoring results are not completely consistent, arbitration logic is executed to obtain a confirmatory monitoring result.

[0092] As an example, the majority of consistent results among multiple preliminary monitoring results can be determined as the confirmed monitoring result. For instance, if the first preliminary monitoring result is "energy output status", the second preliminary monitoring result is "energy not output status", and the third preliminary monitoring result is "energy not output status", then "energy not output status" is the majority, and the confirmed monitoring result is "energy not output status".

[0093] As an example, we can first determine whether the first preliminary monitoring result and the second preliminary monitoring result are consistent. If the results are consistent, the consistency between the first preliminary monitoring result and the second preliminary monitoring result is determined as the confirmed monitoring result. For example, if both the first preliminary monitoring result and the second preliminary monitoring result are "energy output state", then the confirmed monitoring result can be directly considered as "energy output state".

[0094] Alternatively, in response to inconsistencies in the results, the third preliminary monitoring result is determined as the confirmed monitoring result. That is, if the first preliminary monitoring result and the second preliminary monitoring result are "energy output state" and "energy not output state" respectively, and the third preliminary monitoring result is "energy output state", then the confirmed monitoring result is "energy output state"; or, if the third preliminary monitoring result is "energy not output state", then the confirmed monitoring result is "energy not output state".

[0095] For example, the following table shows the results of confirmed monitoring results obtained based on the first, second, and third preliminary monitoring results in the two examples above:

[0096] First monitoring results Second monitoring results Third monitoring results Confirm monitoring results Output Output Output Output Output Output No output Output Output No output Output Output Output No output No output No output No output Output Output Output No output Output No output No output No output No output Output No output No output No output No output No output

[0097] When the preliminary monitoring results are not limited to the first, second, and third preliminary monitoring results, if the majority consensus is still considered the confirming monitoring result (i.e., each preliminary monitoring result is considered to have equal importance), the reliability of the majority consensus preliminary monitoring results may not be as high as that of the minority consensus monitoring results, and there may be some error. As an example, different preset weights can be set according to the different reliability of each of the preliminary monitoring results. The weighted sum score of each group of consistent preliminary monitoring results can be calculated, and the group of preliminary monitoring results with the higher weighted sum score can be determined as the confirming monitoring result. The closer the monitoring result is to "directly" judging the ultrasound energy output, the higher its preset weight value. For example, according to the weight, the result would be: third monitoring result > fourth monitoring result > second monitoring result > fifth monitoring result > first monitoring result. If the third and fourth monitoring results are consistent, even if the second, fifth, and first monitoring results are different, it is still possible to obtain a confirming monitoring result of "energy output status".

[0098] Optionally, besides judging the confirmation monitoring results obtained "at the same time," in other embodiments, multiple preliminary monitoring results obtained within the same time window can also be used to determine the consistency of the confirmation monitoring results to determine whether the focused ultrasound device is in a normal ultrasound energy output state. The time window can be based on retrospective analysis of results obtained at the same time or on historical time. Optionally, the confirmation monitoring result is obtained based on the consistency of the changing trends of different types of preliminary monitoring results within the time window. For example, the changing trend of the first preliminary monitoring result within the time window is obtained, such as from "no energy output state" to "energy output state"; the changing trend of the second preliminary monitoring result is from "no energy output state" to "no energy output state"; the changing trend of the third preliminary monitoring result is from "no energy output state" to "energy output state." According to the first and second example rules of the previous arbitration logic, it can be determined that the focused ultrasound device has changed from "no energy output state" to "energy output state," and the confirmation monitoring result is an energy output state. Using a time window for retrospective analysis to determine the changing trend of preliminary monitoring results can eliminate the interference problem of instantaneous changes in preliminary monitoring results.

[0099] In some embodiments, the computer device may also control the energy output of the focused ultrasound device to eliminate the abnormal event in response to determining an abnormal energy output event based on the confirmed monitoring results, including stopping the output of the power module and / or power amplifier circuit through the control unit. For example, if a first preliminary monitoring result determines that the energy is not outputting, and a second and third preliminary monitoring result determines the energy output status, then an abnormal event can be identified. Alternatively, an abnormal event can also be identified based on any type of equipment operation information or environmental information collected. For example, parameter values ​​in the equipment operation information exceed preset normal thresholds (e.g., exceed preset proportions or values), such as the voltage / current value in the power supply parameter information of the power module exceeding a preset normal threshold a%. Or, parameter values ​​in the environmental information significantly exceed normal thresholds, such as the temperature value of the power module exceeding a preset normal threshold b%, exhibiting an overheating pattern.

[0100] To address the abnormal event, the computer device may include an adjustment mechanism that triggers an adjustment action on the focused ultrasound device based on the abnormal event, thereby adjusting the energy output of the focused ultrasound device to eliminate the abnormal event. For example, the control unit may stop the energy output of the energy amplification module, and / or the control unit may stop the output of the power supply module and / or the power amplification circuit.

[0101] In some embodiments, the safety of medical devices such as focused ultrasound equipment is of paramount importance. Therefore, the computer device may also be equipped with a warning and reminder mechanism that can be triggered by abnormal events to alert pre-set relevant personnel in order to eliminate potential risks in a timely manner, such as the communication / operation of focused ultrasound equipment may be subject to delays, errors, or malfunctions.

[0102] In some embodiments, the computer device can save monitoring results and related equipment operation information, environmental information, etc., in log form, providing them to operators for post-event analysis and achieving better maintainability and traceability. To further improve versatility, the log data storage format complies with the data security standards for medical devices, ensuring data integrity and privacy protection.

[0103] like Figure 4 The diagram shows a schematic of a high-intensity focused ultrasound (HIFU) energy output monitoring device according to an embodiment of this disclosure. It should be noted that the principle and technical implementation of the HIFU energy output monitoring device can be referenced from the HIFU energy output monitoring method in previous embodiments; therefore, it will not be repeated in this embodiment.

[0104] The high-intensity focused ultrasound energy output monitoring device 400 includes:

[0105] The first monitoring module 401 is used to obtain multiple preliminary monitoring results regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the device operation information obtained from the focused ultrasound device, including: obtaining the power amplifier control behavior information of the control unit and determining a first preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the control behavior information; obtaining the power supply parameter information of the power supply module and determining a second preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information;

[0106] The second monitoring module 402 is used to obtain at least one preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasound energy output state based on the collected environmental information affected by the focused ultrasound energy, including: a third preliminary monitoring result based on the acquisition of a monitoring image containing the irradiation location of the high-intensity focused ultrasound energy to identify whether the focused ultrasound device is in an ultrasound energy output state.

[0107] Arbitration module 403 is used to determine, based on the consistency judgment of multiple preliminary monitoring results acquired at the same time, whether the focused ultrasound device is in a normal ultrasound energy output state as a confirmation monitoring result.

[0108] It should be noted that, in Figure 4The various functional modules in the embodiments can be implemented, in whole or in part, by software, hardware, firmware, or any combination thereof. When implemented in software, they can be implemented, in whole or in part, in the form of a computer program or instruction product. A computer program or instruction product includes one or more computer programs or instructions. When a computer program or instruction is loaded and executed on a computer, it produces, in whole or in part, the flow or function according to this disclosure. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer program or instructions can be stored in a computer-readable storage medium or transferred from one computer-readable storage medium to another.

[0109] and, Figure 4 The apparatus disclosed in the embodiments can be implemented through other modular division methods. The apparatus embodiments shown above are merely illustrative. For example, the module division is only a logical functional division, and in actual implementation, there may be other division methods. For example, a group of modules or modules may be combined or dynamically integrated into another system, or some features may be ignored or not executed. Furthermore, the shown or discussed mutual coupling, direct coupling, or communication connection may be through some interfaces, and the indirect coupling or communication connection between devices or modules may be electrical or other forms.

[0110] in addition, Figure 4 The functional modules and sub-modules in the embodiments can be dynamically integrated within a single processing unit, or each module can exist physically independently, or two or more modules can be dynamically integrated within a single unit. These dynamic units can be implemented in hardware or as software functional modules. If these dynamic units are implemented as software functional modules and sold or used as independent products, they can also be stored in a computer-readable storage medium. This storage medium can be a read-only memory, a hard disk, or an optical disk, etc.

[0111] It should be specifically noted that the flowchart representations of the embodiments described above in this disclosure can be understood as representing a module, segment, or portion of code comprising one or more executable instructions configured to implement a specific logical function or process. Furthermore, the scope of the preferred embodiments of this disclosure includes other implementations in which functions may be performed not in the order shown or discussed, including substantially simultaneously or in reverse order depending on the functions involved.

[0112] For example, Figure 4 The order of the steps in the method embodiments may vary in specific scenarios and is not limited to the above representation.

[0113] like Figure 5The diagram shown illustrates the structure of a computer device according to an embodiment of the present disclosure.

[0114] The computer device 300 may be exemplified as a host computer, such as a server, desktop computer, laptop computer, tablet computer, smartphone, or other terminal. Alternatively, the computer device may be implemented as an embedded controller.

[0115] The computer device 300 includes a bus 301, a processor 302, and a memory 303. The processor 302 and the memory 303 can communicate via the bus 301. The memory 303 can store computer programs or instructions. The processor 302 implements the method flow or function described in the previous embodiments by running the computer program or instructions stored in the memory 303, for example... Figure 4 .

[0116] Bus 301 can be a Peripheral Component Interconnect (PCI) bus or an Extended Industry Standard Architecture (EISA) bus, etc. Buses can be categorized as address buses, data buses, control buses, etc. For ease of representation, although only one thick line is used in the diagram, this does not indicate that there is only one bus or one type of bus.

[0117] In some embodiments, processor 302 may be implemented as a central processing unit (CPU), microprocessor unit (MCU), system on chip (System on Chip), or field-programmable array (FPGA). Memory 303 may include volatile memory for temporary data storage during program execution, such as random access memory (RAM).

[0118] The memory 303 may also include non-volatile memory for data storage, such as read-only memory (ROM), flash memory, hard disk drive (HDD), or solid-state disk (SSD).

[0119] In some embodiments, the computer device 300 may further include a communicator 304. The communicator 304 is used for communication with external devices. In specific examples, the communicator 304 may include one or more wired and / or wireless communication circuit modules. For example, the communicator 304 may include one or more of, such as a wired network card, a USB module, a serial interface module, etc. The wireless communication protocols followed by the wireless communication module include, for example, Nearfield Communication (NFC) technology, Infrared (IR) technology, Global System for Mobile Communications (GSM), General Packet Radio Service (GPRS), Code Division Multiple Access (CDMA), Wideband Code Division Multiple Access (WCDMA), Time-Division Code Division Multiple Access (TD-SCDMA), Long Term Evolution (LTE), Bluetooth (BT), Global Navigation Satellite System (GNSS), etc.

[0120] This disclosure also provides a computer-readable storage medium storing a computer program or instructions, which, when run, implement the method flow or function of any of the previous embodiments.

[0121] That is, the method steps in the above embodiments are implemented as software or computer code that can be stored in a recording medium (such as CD ROM, RAM, floppy disk, hard disk or magneto-optical disk), or implemented as computer code that is originally stored in a remote recording medium or a non-transitory machine-readable medium and will be stored in a local recording medium after being downloaded via a network, so that the method represented herein can be stored in such software processing on a recording medium using a general-purpose computer, a special processor or programmable or special hardware (such as ASIC or FPGA).

[0122] This disclosure may also provide a computer program product, comprising one or more computer programs or instructions, which, when run, perform all or part of the processes or functions described in this disclosure. The computer program product includes one or more computer programs or instructions.

[0123] Computer programs or instructions can be stored in a readable storage medium or transferred from one readable storage medium to another. For example, the computer program or instructions can be transferred from one website, computer, server, or data center to another website, computer, server, or data center via wired or wireless means. The readable storage medium can be any available medium capable of access, or a data storage device such as a server or data center that integrates one or more available media. The available medium can be a magnetic medium, such as a floppy disk, hard disk, or magnetic tape; an optical medium, such as a digital video optical disc; or a semiconductor medium, such as a solid-state drive. The computer-readable storage medium can be a volatile or non-volatile storage medium, or it can include both volatile and non-volatile types of storage media.

[0124] In summary, as described above, this disclosure relates to the field of medical device technology, providing a method and system for monitoring high-intensity focused ultrasound (HIFU) energy output. Based on acquired equipment operation information of the HIFU device, multiple preliminary monitoring results are obtained regarding whether the HIFU device is in an ultrasound energy output state. These include a first preliminary monitoring result determined based on control behavior information; a second preliminary monitoring result determined based on power supply parameter information of the power module; and at least one preliminary monitoring result based on collected environmental information affected by the HIFU energy, including a third preliminary monitoring result obtained based on monitoring images of the irradiation location. A confirmatory monitoring result is then obtained by performing multi-dimensional judgment based on these multiple preliminary monitoring results to determine whether the HIFU device is in an ultrasound energy output state. Therefore, through multi-dimensional monitoring and comprehensive judgment, energy output can be verified in real time and accurately, improving treatment safety and effectiveness.

[0125] The above embodiments are merely illustrative of the principles and effects of this disclosure and are not intended to limit this disclosure. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this disclosure. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this disclosure should still be covered by the protection scope of this disclosure.

Claims

1. A method of high intensity focused ultrasound energy output monitoring, characterized by, The high-intensity focused ultrasound energy is output by a focused ultrasound device, which includes: an energy amplification module that outputs an ultrasound excitation signal to an ultrasound transducer for generating high-intensity focused ultrasound energy; a power supply module that supplies power to the energy amplification module; and a control unit that controls the energy amplification module to generate the ultrasound excitation signal output. The method includes: Based on the device operation information obtained from the focused ultrasound device, several preliminary monitoring results are obtained regarding whether the focused ultrasound device is in an ultrasonic energy output state, including: obtaining the power amplifier control behavior information of the control unit and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the control behavior information; obtaining the power supply parameter information of the power module and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information; Based on the environmental information collected that is affected by the focused ultrasound energy, at least one preliminary monitoring result is obtained regarding whether the focused ultrasound device is in an ultrasound energy output state, including: a third preliminary monitoring result based on the acquisition of a monitoring image of the irradiation location containing the high-intensity focused ultrasound energy, and identification to determine whether the focused ultrasound device is in an ultrasound energy output state. Based on the consistency of multiple preliminary monitoring results acquired at the same time, a confirmation monitoring result is obtained to determine whether the focused ultrasound device is in a normal ultrasound energy output state.

2. The high intensity focused ultrasound energy output monitoring method of claim 1, wherein, The first preliminary monitoring result of acquiring the power amplifier control behavior information of the control unit and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the control behavior information includes: The control unit acquires an on / off notification signal and a stop notification signal; wherein, the control unit generates and sends the on / off notification signal when it outputs a first control command to enable the power amplifier circuit's power amplifier energy output; and, in response to satisfying a preset output stop condition, the control unit outputs a second control command to stop the power amplifier circuit's power amplifier energy output, and generates and sends the stop notification signal; the preset output stop condition includes at least one of: a timer established in conjunction with the first control command expiring, accumulated energy reaching a target, or being triggered by an external command; The first preliminary monitoring result is determined based on the start notification signal and the stop notification signal.

3. The high intensity focused ultrasound energy output monitoring method of claim 2, wherein, include: Based on the consistency of multiple preliminary monitoring results within the same time window, a confirmation monitoring result is obtained to determine whether the focused ultrasound device is in a normal ultrasound energy output state.

4. The high intensity focused ultrasound energy output monitoring method of claim 1, wherein, The second preliminary monitoring result, which involves acquiring the power supply parameter information of the power module and determining whether the focused ultrasound device is in an ultrasonic energy output state based on the power supply parameter information, includes: Obtain the first output power information of the power module; The power supply status of the power module is determined based on the first output power information; The second preliminary monitoring result is determined based on the power supply status.

5. The high-intensity focused ultrasound energy output monitoring method according to claim 1, characterized in that, The third preliminary monitoring result, which identifies whether the focused ultrasound device is in an ultrasonic energy output state based on the monitoring image of the irradiated location containing the high-intensity focused ultrasound energy, includes: Acquire the monitoring image; The image feature difference information of the target region between the monitoring images of the preceding and following frames is obtained; the image features include at least one of brightness, texture, contrast, edge features, or feature vectors extracted based on a feature extraction model; Based on the image feature difference information, determine whether the target area has experienced an irradiation event caused by ultrasonic energy, so as to obtain the third preliminary monitoring result.

6. The high-intensity focused ultrasound energy output monitoring method according to claim 1, characterized in that, Based on the equipment operation information obtained from the focused ultrasound device, several preliminary monitoring results are obtained regarding whether the focused ultrasound device is in an ultrasonic energy output state, including: The fourth preliminary monitoring result is to obtain the second output power information of the energy amplification module and determine whether the focused ultrasound device is in an ultrasound energy output state based on the second output power information. And / or, based on the environmental information collected that is affected by the focused ultrasound energy, at least one preliminary monitoring result is obtained regarding whether the focused ultrasound device is in an ultrasound energy output state, including: The fifth preliminary monitoring result is to collect temperature information of the focused ultrasound device or irradiation location and determine whether the focused ultrasound device is in an ultrasonic energy output state based on the temperature information.

7. The high-intensity focused ultrasound energy output monitoring method according to claim 1, characterized in that, The confirmation monitoring result, which determines whether the focused ultrasound device is in a normal ultrasound energy output state based on the consistency judgment of multiple preliminary monitoring results acquired at the same time, includes: If multiple preliminary monitoring results are consistent, the consistent result is determined as the confirmed monitoring result; In response to inconsistencies among multiple preliminary monitoring results, the following arbitration logic will be implemented: 1) The majority of consistent results among the multiple preliminary monitoring results are determined as the confirmed monitoring results; 2) Determine whether the first preliminary monitoring result and the second preliminary monitoring result are consistent; if they are consistent, then determine the consistent result as the confirmed monitoring result; if they are inconsistent, then further determine whether the third preliminary monitoring result meets the preset image validity conditions; if the validity conditions are met, then determine the third preliminary monitoring result as the confirmed monitoring result; if the third preliminary monitoring result does not meet the validity conditions, then determine that the energy output is abnormal and trigger the safety protection logic. 3) Based on the preset weight of each of the preliminary monitoring results, a consistent weighted sum score is obtained for each group of preliminary monitoring results, and the group of preliminary monitoring results with the higher weighted sum score is determined as the confirmed monitoring result.

8. The high-intensity focused ultrasound energy output monitoring method according to claim 1, characterized in that, Also includes: In response to determining an abnormal energy output event based on the confirmed monitoring results, controlling the energy output of the focused ultrasound device to eliminate the abnormal event includes: stopping the output of the power module and / or power amplifier circuit via the control unit.

9. A computer device, characterized in that, include: Communicator, processor, memory; The communicator is connected to the focused ultrasound device. The memory stores computer programs or instructions; The processor is configured to run the computer program or instructions to perform the high-intensity focused ultrasound energy output monitoring method as described in any one of claims 1 to 8.

10. A high-intensity focused ultrasound energy output monitoring system, characterized in that, include: The image acquisition device is configured to acquire monitoring images of the target area irradiated by the high-intensity focused ultrasound energy output by the focused ultrasound device. The monitoring module is configured to acquire equipment operation information output by the focused ultrasound device; The computer device as described in claim 9, communicatively connected to the image acquisition device and the monitoring module, is used to obtain multiple preliminary monitoring results regarding whether the focused ultrasound device is in an ultrasonic energy output state based on the device operation information acquired from the focused ultrasound device, including: Acquire the power amplifier control behavior information of the control unit, and determine the first preliminary monitoring result of whether the focused ultrasound device is in the ultrasonic energy output state based on the control behavior information; The power supply parameter information of the power module is obtained, and a second preliminary monitoring result is determined based on the power supply parameter information to determine whether the focused ultrasound device is in the ultrasonic energy output state. The computer device is used to obtain at least one preliminary monitoring result regarding whether the focused ultrasound device is in an ultrasound energy output state based on acquired environmental information affected by the focused ultrasound energy, including: identifying a third preliminary monitoring result based on acquired monitoring images containing the irradiated location of the high-intensity focused ultrasound energy to determine whether the focused ultrasound device is in an ultrasound energy output state; and, The computer device is also used to determine, based on the consistency judgment of multiple preliminary monitoring results acquired at the same time, whether the focused ultrasound device is in a normal ultrasound energy output state as a confirmation monitoring result.

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