High-intensity focused ultrasound equipment and its synchronous control method

Abstract

This application relates to a high-intensity focused ultrasound (HIFU) device and its synchronous control method. The device includes a time synchronization controller, a motion control device, an imaging ultrasound device, and a focused ultrasound device. The time synchronization controller sends motion control trigger signals to the motion control device, focused ultrasound trigger signals to the focused ultrasound device, and imaging ultrasound trigger signals to the imaging ultrasound device. The transmission times of the focused ultrasound trigger signals and the imaging ultrasound trigger signals are set to have a time difference. The motion control device performs motion control based on the motion control trigger signals, the focused ultrasound device performs focusing control based on the focused ultrasound trigger signals, and the imaging ultrasound device performs image acquisition control based on the imaging ultrasound trigger signals. By ensuring that the imaging ultrasound device and the focused ultrasound device do not operate simultaneously, the transducer of the focused ultrasound device is prevented from affecting the monitoring effect of the imaging ultrasound device in the region of interest.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a high-intensity focused ultrasound device and its synchronous control method. Background Technology

[0002] High-intensity focused ultrasound (HIFU) is a non-invasive treatment technique that utilizes the tissue-penetrating and energy-focusing properties of ultrasound waves to focus low-energy ultrasound waves from outside the body onto the deep lesion (target area). The high-energy ultrasound waves generated in the focal area kill tumor cells through instantaneous high-temperature and cavitation effects, while causing almost no damage to tissues outside the target area.

[0003] Traditional high-intensity focused ultrasound (HIFU) devices, such as the hardware system described in patent 202020055114.7, include a high-energy focused ultrasound device, an imaging ultrasound device, a motion mechanism, and a controller. The movement of the focal point can be achieved in two ways: 1. For phased array transducers, this can be achieved by changing the phase of each channel; 2. For single-channel transducers, this can be achieved by moving the entire transducer. Compared to the second method, the first method can achieve higher speeds, but its accuracy is lower and it is easily affected by environmental factors and refraction and reflection during sound wave transmission. Phased array transducers also have higher requirements for the equipment and lower unit output energy. Furthermore, for phased array transducers, once the position and focal point are determined, the transmission trajectory of the ultrasound waves cannot be changed. The second method, however, requires external mechanisms to move the focal point.

[0004] The hardware system described in patent 202020055114.7 can move the focus by 1 millisecond in just a few milliseconds. High-intensity focused ultrasound (HIFU) uses cavitation effects for treatment, emitting energy in pulses, requiring pauses of tens of milliseconds or more between pulses. Therefore, this system can perform the control method described in patent 202010412554.8 without sacrificing efficiency. In patent 202010412554.8, to ensure safety, the energy pulses must have a cycle i that is not shorter than a fixed time interval. When the time is shorter than the predetermined time interval, the system will wait for a certain period until the time interval between pulses meets the requirements. Because the focused ultrasound transducer generates significant acoustic and electromagnetic interference to the imaging ultrasound, traditional high-intensity focused ultrasound equipment does not control the timing, easily causing uncontrollable interference to image acquisition, making the monitoring effect unsatisfactory. Summary of the Invention

[0005] Therefore, it is necessary to provide a high-intensity focused ultrasound device and its synchronous control method to address the above problems and avoid the impact of transducer operation on monitoring results.

[0006] A high-intensity focused ultrasound device includes a time synchronization controller, a motion control device, an imaging ultrasound device, and a focused ultrasound device, wherein the time synchronization controller is connected to the motion control device, the imaging ultrasound device, and the focused ultrasound device.

[0007] The time synchronization controller is used to send motion control trigger signals to the motion control device, send focused ultrasound trigger signals to the focused ultrasound device, and send imaging ultrasound trigger signals to the imaging ultrasound device, wherein the sending times of the focused ultrasound trigger signals and the imaging ultrasound trigger signals are set to have a time difference;

[0008] The motion control device is used to return a motion start signal to the time synchronization controller when it receives the motion control trigger signal, perform motion control according to the motion control trigger signal, and return a motion end signal to the time synchronization controller after the movement ends.

[0009] The focused ultrasound device is used to return a radio frequency energy start signal to the time synchronization controller after receiving the focused ultrasound trigger signal, perform focusing control according to the focused ultrasound trigger signal, and return a radio frequency energy end signal to the time synchronization controller after ending the ultrasound pulse release.

[0010] The imaging ultrasound device is used to return an ultrasound image acquisition start signal to the time synchronization controller after receiving an imaging ultrasound trigger signal, perform image acquisition control according to the imaging ultrasound trigger signal, and return an ultrasound image acquisition end signal to the time synchronization controller after ending image acquisition.

[0011] In one embodiment, when the imaging ultrasound device is in imaging ultrasound mode with a region of interest, the time synchronization controller is further configured to adjust the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal, so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

[0012] In one embodiment, the imaging ultrasound device includes an imaging ultrasound host and an imaging ultrasound probe, wherein the imaging ultrasound host is connected to the time synchronization controller and the imaging ultrasound probe.

[0013] In one embodiment, the focused ultrasound device includes a radio frequency energy source and a focused ultrasound transducer, wherein the radio frequency energy source is connected to the time synchronization controller and the focused ultrasound transducer.

[0014] In one embodiment, the motion control device includes a motion controller and a motion mechanism, the motion controller being connected to the time synchronization controller and the motion mechanism, the motion mechanism being used to control the movement of the focused ultrasound transducer.

[0015] In one embodiment, the radio frequency energy source controls the focused ultrasound transducer to release a high-intensity focused ultrasound pulse once within a working cycle according to the focused ultrasound trigger signal; the motion controller controls the motion mechanism to move the focused ultrasound transducer once within a working cycle according to the motion control trigger signal; and the imaging ultrasound host controls the imaging ultrasound probe to perform more than two image acquisitions within a working cycle according to the imaging ultrasound trigger signal.

[0016] In one embodiment, the duration of the image ultrasound trigger signal refers to the time it takes for the image ultrasound to acquire one frame of an image, which is 0.1-10.0 ms, and the frame rate is 20-50 Hz.

[0017] In one embodiment, the duration of the focused ultrasound trigger signal refers to the time for releasing one high-intensity focused ultrasound pulse, which is 1 to 20 ms; the duration of the motion control trigger signal refers to the time for performing one movement, which is 20 to 500 ms.

[0018] In one embodiment, the time interval between two focused ultrasound trigger signals is 50 to 500 ms.

[0019] In one embodiment, the time interval between the start time of the imaging ultrasound trigger signal and the start time of the focused ultrasound trigger signal is 5ms.

[0020] In one embodiment, a synchronous control method for a high-intensity focused ultrasound (HIFU) device is provided, based on the aforementioned HIFU device, and includes the following steps:

[0021] A focused ultrasound trigger signal is sent to the focused ultrasound device, and the focused ultrasound trigger signal is used by the focused ultrasound device to perform focusing control; after receiving the focused ultrasound trigger signal, the focused ultrasound device returns a radio frequency energy start signal to the time synchronization controller, performs focusing control according to the focused ultrasound trigger signal, and returns a radio frequency energy end signal to the time synchronization controller after ending the ultrasound pulse release.

[0022] A motion control trigger signal is sent to the motion control device, which is used by the motion control device to perform motion control; when the motion control device receives the motion control trigger signal, it returns a motion start signal to the time synchronization controller, performs motion control according to the motion control trigger signal, and returns a motion end signal to the time synchronization controller after the movement ends.

[0023] An imaging ultrasound trigger signal is sent to the imaging ultrasound device, which is used by the imaging ultrasound device to control image acquisition; wherein, the transmission time of the focusing ultrasound trigger signal and the imaging ultrasound trigger signal is set to have a time difference; after receiving the imaging ultrasound trigger signal, the imaging ultrasound device returns an ultrasound image acquisition start signal to the time synchronization controller, performs image acquisition control according to the imaging ultrasound trigger signal, and returns an ultrasound image acquisition end signal to the time synchronization controller after ending image acquisition.

[0024] In one embodiment, the method further includes:

[0025] Acquire the imaging ultrasound mode of the imaging ultrasound device;

[0026] When the imaging ultrasound mode of the imaging ultrasound device is in the imaging ultrasound mode with a region of interest, the time difference between the transmission time of the focused ultrasound trigger signal and the imaging ultrasound trigger signal is adjusted so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

[0027] The aforementioned high-intensity focused ultrasound equipment and its synchronous control method use a time synchronization controller to send corresponding signals to synchronously control the operation of the motion control device, the imaging ultrasound device, and the focused ultrasound device, and ensure that the imaging ultrasound device and the focused ultrasound device do not work simultaneously, thus avoiding the transducer of the focused ultrasound device from affecting the monitoring effect of the imaging ultrasound device. Attached Figure Description

[0028] Figure 1 This is a structural block diagram of a high-intensity focused ultrasound device in one embodiment;

[0029] Figure 2 This is a schematic diagram of the structure of a high-intensity focused ultrasound device in one embodiment;

[0030] Figure 3 This is a schematic diagram of the timing control of a high-intensity focused ultrasound device in one embodiment;

[0031] Figure 4 This is a schematic diagram of an ultrasound image in one embodiment, showing the high-intensity focused ultrasound pulse displayed in the region of interest.

[0032] Figure 5 This is a schematic diagram of an ultrasound image being interfered with by a high-intensity focused ultrasound pulse in one embodiment;

[0033] Figure 6 This is a schematic diagram of an ultrasound image in one embodiment where the high-intensity focused ultrasound pulse is displayed outside the region of interest.

[0034] Figure 7 This is a schematic diagram of an ultrasound image in one embodiment when it is not interfered with by a high-intensity focused ultrasound pulse. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0037] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "above," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "below" of the other element or feature will be oriented "above" the other element or feature. Therefore, the exemplary terms "below" and "below" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90 degrees or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0038] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0039] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising / including” or “having,” etc., specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof. Furthermore, the terms used in this specification include any and all combinations of the associated listed items.

[0040] In one embodiment, such as Figure 1 As shown, a high-intensity focused ultrasound (HIFU) device is provided, including a time synchronization controller 100, a motion control device 200, an imaging ultrasound device 300, and a focused ultrasound device 400. The time synchronization controller 100 is connected to the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400. The time synchronization controller 100 is used to send motion control trigger signals to the motion control device 200, send focused ultrasound trigger signals to the focused ultrasound device 400, and send imaging ultrasound trigger signals to the imaging ultrasound device 300. The transmission times of the focused ultrasound trigger signals and the imaging ultrasound trigger signals are set to have a time difference, which can be maintained at a fixed time difference. The motion control device 200 is used to return a motion start signal to the time synchronization controller 100 when it receives the motion control trigger signal, perform motion control according to the motion control trigger signal, and return a motion end signal to the time synchronization controller 100 after the movement ends. The focused ultrasound device 400 is used to return a radio frequency energy start signal to the time synchronization controller 100 after receiving a focused ultrasound trigger signal, perform focusing control according to the focused ultrasound trigger signal, and return a radio frequency energy end signal to the time synchronization controller 100 after the ultrasound pulse release ends. The imaging ultrasound device 300 is used to return an ultrasound image acquisition start signal to the time synchronization controller 100 after receiving an imaging ultrasound trigger signal, perform image acquisition control according to the imaging ultrasound trigger signal, and return an ultrasound image acquisition end signal to the time synchronization controller after the image acquisition ends.

[0041] When the motion control device 200 receives a motion control trigger signal, it moves the focused ultrasound device 400 to focus irradiation on different locations within the cavity of the object to be treated. When the motion control trigger signal ends, the motion control device 200 stops moving. The motion control trigger signal output by the time synchronization controller 100 can be set to allow the motion control device 200 to move once or multiple times within a working cycle. When the focused ultrasound device 400 receives a focused ultrasound trigger signal, it releases high-intensity focused ultrasound pulses to focus irradiation on the area to be treated within the cavity of the object to be treated, forming localized high-intensity focused ultrasound energy to ablate the target tissue. When the focused ultrasound trigger signal ends, the focused ultrasound device 400 stops releasing high-intensity focused ultrasound pulses. The focused ultrasound trigger signal output by the time synchronization controller 100 can be set to allow the focused ultrasound device 400 to release pulses once or multiple times within a working cycle. When the imaging ultrasound trigger signal receives an imaging ultrasound trigger signal, the imaging ultrasound device 300 acquires and uploads images of the cavity of the object to be treated to monitor the target area. When the imaging ultrasound trigger signal ends, the imaging ultrasound device 300 stops acquiring images. Similarly, the imaging ultrasound trigger signal output by the time synchronization controller 100 can be set to enable the imaging ultrasound device 300 to perform one or more image acquisitions within the working cycle.

[0042] Specifically, the time synchronization controller 100 can synchronously control the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400 according to two time sequences. One time sequence is: motion-emission energy-motion-emission energy-…, which repeats continuously, that is, it outputs motion control trigger signals and focused ultrasound trigger signals in a loop, controlling the focused ultrasound device 400 and the motion control device 200 to perform operations cyclically. For example, in one working cycle, it first controls the focused ultrasound device 400 to focus, then controls the motion control device 200 to move, and then in the next working cycle, it continues to control the focused ultrasound device 400 to focus, then controls the motion control device 200 to move. The other time sequence is: image ultrasound-image ultrasound-image ultrasound-…, that is, it continuously outputs image ultrasound trigger signals in a loop, controlling the image ultrasound device 300 to perform operations. For example, in one working cycle, it controls the image ultrasound device 300 to continuously perform multiple image acquisitions. The time sequence is set by the time synchronization controller 100 so that the focused ultrasound device 400 and the imaging ultrasound device 300 do not operate simultaneously. For example, at the beginning of the work cycle, the focused ultrasound device 400 performs a pulse release operation, and then controls the motion control device 200 and the imaging ultrasound device 300 to operate for the remainder of the work cycle. By using the time synchronization controller 100 to synchronously control the operation of the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400, ultrasonic pulse processing and image acquisition can be performed separately for different areas of the cavity to be treated, facilitating unified management and maximizing ablation efficiency.

[0043] The aforementioned high-intensity focused ultrasound device sends corresponding signals through the time synchronization controller 100 to synchronously control the operation of the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400, and ensures that the imaging ultrasound device 300 and the focused ultrasound device 400 do not work at the same time and maintain a fixed time difference, so as to avoid the transducer of the focused ultrasound device 400 from affecting the monitoring effect of the imaging ultrasound device 300.

[0044] In one embodiment, such as Figure 2 As shown, the imaging ultrasound device 300 includes an imaging ultrasound host 310 and an imaging ultrasound probe 320. The imaging ultrasound host 310 is connected to the time synchronization controller 100 and the imaging ultrasound probe 320. The imaging ultrasound host 310 receives the imaging ultrasound trigger signal sent by the time synchronization controller 100, and controls the imaging ultrasound probe 320 to perform image acquisition operation when it receives the imaging ultrasound trigger signal.

[0045] In one embodiment, the focused ultrasound device 400 includes a radio frequency energy source 410 and a focused ultrasound transducer 420. The radio frequency energy source 410 is connected to a time synchronization controller 100 and the focused ultrasound transducer 420. The radio frequency energy source 410 receives a focused ultrasound trigger signal sent by the time synchronization controller 100 and releases a high-intensity focused ultrasound pulse upon receiving the focused ultrasound trigger signal.

[0046] In one embodiment, the motion control device 200 includes a motion controller 210 and a motion mechanism 220. The motion controller 210 is connected to the time synchronization controller 100 and the motion mechanism 220, and the motion mechanism 220 is used to control the movement of the focused ultrasound transducer 420. The motion controller 210 receives a motion control trigger signal sent by the time synchronization controller 100, and controls the motion mechanism 220 to move the focused ultrasound transducer 420 once when it receives the motion control trigger signal. In addition, the imaging ultrasound probe 320 can be fixedly set with the focused ultrasound transducer 420, so that the imaging ultrasound probe 320 moves along with the focused ultrasound transducer 420, which makes it more convenient for the imaging ultrasound probe 320 to acquire images of the target area of ​​the focused ultrasound transducer 420.

[0047] Furthermore, in one embodiment, the radio frequency energy source 410 controls the focused ultrasound transducer 420 to release a high-intensity focused ultrasound pulse once within the working cycle according to the focused ultrasound trigger signal; the motion controller 210 controls the motion mechanism 220 to move the focused ultrasound transducer 420 once within the working cycle according to the motion control trigger signal; and the imaging ultrasound host 310 controls the imaging ultrasound probe 320 to perform more than two image acquisitions within the working cycle according to the imaging ultrasound trigger signal.

[0048] Specifically, within a work cycle, after the focused ultrasound transducer 420 releases a high-intensity focused ultrasound pulse once, the motion mechanism 220 is moved once to release an ultrasound pulse to the next area to be treated. In traditional solutions, the focused ultrasound transducer 420 may release a high-intensity focused ultrasound pulse only once per work cycle, irradiating only one area. After irradiation, the remaining time in the work cycle is used for rest. In this embodiment, however, the motion controller 210, based on a motion control trigger signal, controls the motion mechanism 220 to move the focused ultrasound transducer 420 within the work cycle to another area to be treated. This allows for separate ultrasound pulse processing and image acquisition of different areas within the cavity of the object to be treated within a single work cycle, significantly reducing the total processing time for multiple areas and improving work efficiency.

[0049] After the focused ultrasound transducer 420 releases a high-intensity focused ultrasound pulse, the imaging ultrasound probe 320 is controlled to perform multiple image acquisitions within the current working cycle, for example, three image acquisitions. The time for the imaging ultrasound probe 320 to acquire images can coincide with or not coincide with the movement time of the motion mechanism 220.

[0050] Specifically, in one embodiment, such as Figure 2 and 3 As shown, after receiving the focused ultrasound trigger signal, the radio frequency energy source 410 returns a radio frequency energy start signal to the time synchronization controller 100, and controls the focused ultrasound transducer 420 to release ultrasound pulses. After the ultrasound pulse release ends, it also returns a radio frequency energy end signal to the time synchronization controller 100. When the motion controller 210 receives the motion control trigger signal, it returns a motion start signal to the time synchronization controller 100, and controls the motion mechanism 220 to move. After the movement ends, it returns a motion end signal to the time synchronization controller 100. When the imaging ultrasound host 310 receives the imaging ultrasound trigger signal, it returns an ultrasound image acquisition start signal to the time synchronization controller 100, and controls the imaging ultrasound probe 320 to acquire images. After the image acquisition ends, it returns an ultrasound image acquisition end signal to the time synchronization controller 100.

[0051] In this embodiment, before and after performing their respective operations, the radio frequency energy source 410, motion controller 210, and imaging ultrasound host 310 also send corresponding start and end signals to the time synchronization controller 100, so that the time synchronization controller 100 can know the working status of the radio frequency energy source 410, motion controller 210, and imaging ultrasound host 310.

[0052] It is understood that the specific durations of the focused ultrasound trigger signal, motion control trigger signal, and imaging ultrasound trigger signal, as well as the time intervals between the signals, are not unique. In one embodiment, the duration of the imaging ultrasound trigger signal refers to the time it takes for imaging ultrasound to acquire one frame of an image, which is 0.1-10.0 ms, specifically 1 ms, with a frame rate of 20-50 Hz. Further, in one embodiment, the duration of the focused ultrasound trigger signal refers to the time it takes to release one high-intensity focused ultrasound pulse, which is 1-20 ms; the duration of the motion control trigger signal refers to the time it takes to perform one movement, which is 20-500 ms.

[0053] In one embodiment, the time interval between two focused ultrasound trigger signals is 50–500 ms. Furthermore, in one embodiment, the time interval between the start time of the imaging ultrasound trigger signal and the start time of the focused ultrasound trigger signal is 5 ms. Specifically, the time interval from the start time of the last imaging ultrasound trigger signal of the previous work cycle to the start time of the focused ultrasound trigger signal of the current work cycle is 5 ms.

[0054] In one embodiment, the high-intensity focused ultrasound (HIFU) device may further include a host computer, which may specifically be a computer. The host computer is connected to a time synchronization controller 100, and parameters of the time synchronization controller 100 can be set via the host computer, such as setting the relevant signals sent by the time synchronization controller 100. Furthermore, the host computer may also be connected to a motion controller 210, and operating parameters of the motion controller 210 can be set, such as setting the specific movement amplitude of the motion mechanism 220 controlled by the motion controller 210 within a working cycle. In addition, the host computer may also be connected to an imaging ultrasound host 310, through which data collected by the imaging ultrasound probe 320 is received and uploaded to the host computer for storage or display.

[0055] In one embodiment, when the imaging ultrasound device 300 is in imaging ultrasound mode with a region of interest, the time synchronization controller 100 is also used to adjust the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal, so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

[0056] The imaging ultrasound device 300 possesses multiple imaging ultrasound modes, such as standard B-mode, color Doppler mode, and elastography mode. Understandably, the observational information obtainable from the ultrasound images acquired by the imaging ultrasound device 300 based on the imaging ultrasound trigger signal varies depending on the mode. For example, in standard B-mode, the ultrasound image has a single color and limited information, only a visual color change; further human judgment may be needed to determine the extent of tissue changes. In color Doppler mode, the ultrasound image can observe changes in blood vessels or tumors in dangerous areas of the organ treated by high-intensity focused ultrasound pulses, and color can be used to display changes in tissue movement in the treated area. In elastography mode, the ultrasound image can observe changes in tissue rigidity within the area treated by high-intensity focused ultrasound pulses to determine the success of the treatment.

[0057] Furthermore, the switching of different imaging ultrasound modes of the imaging ultrasound device 300 can be performed in a manner commonly used by those skilled in the art. For example, the imaging ultrasound host 310 can adjust the probe scanning parameters (e.g., frequency or beamforming method) of the imaging ultrasound probe 320 and the algorithm inside the imaging ultrasound host 310 according to the imaging ultrasound mode selected by the user, thereby realizing the switching of different imaging ultrasound modes of the imaging ultrasound device 300, which will not be elaborated here.

[0058] It is understandable that, in order to achieve accurate monitoring of the treatment process, ultrasound images need to be acquired within a precise timeframe after the high-intensity focused ultrasound pulse is emitted. While the time synchronization controller 100 synchronously controls the operation of the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400, the high-intensity focused ultrasound pulse may also be displayed in the ultrasound images acquired by the imaging ultrasound device 300, such as... Figure 4 As shown. However, when the imaging ultrasound device 300 is in imaging ultrasound mode with a region of interest, the high-intensity focused ultrasound pulse may cause ripple interference due to the sensitivity of the observation information in the region of interest, resulting in distortion of the ultrasound image in the region of interest, such as... Figure 5 As shown. Therefore, when the imaging ultrasound device 300 is in imaging ultrasound mode with a region of interest, it is necessary to control the display position of the high-intensity focused ultrasound pulse in the ultrasound image to be outside the region of interest to avoid ripple interference caused by the high-intensity focused ultrasound pulse, such as... Figure 6 and Figure 7 As shown.

[0059] Specifically, the imaging ultrasound mode with a region of interest (ROI) in the imaging ultrasound device 300 can be either color Doppler mode or elastography mode. The time synchronization controller 100 is also used to adjust the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal, so that the high-intensity focused ultrasound pulse is displayed outside the ROI in the ultrasound image. The method for adjusting the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal can be determined according to the actual situation. For example, in one embodiment, to ensure real-time monitoring, the time synchronization controller 100 sends a real-time imaging ultrasound trigger signal to the imaging ultrasound host 310, and then adjusts the time difference according to the actual position of the ROI, advancing or delaying the release of the focused ultrasound trigger signal, so that the high-intensity focused ultrasound pulse is displayed outside the ROI in the ultrasound image. In another embodiment, to control the treatment effect, the time synchronization controller 100 sends a focused ultrasound trigger signal to the radio frequency energy source 410 according to a set frequency, and then adjusts the time difference according to the actual position of the ROI, i.e., advancing or delaying the imaging ultrasound trigger signal.

[0060] In one embodiment, a synchronous control method for a high-intensity focused ultrasound (HIFU) device is also provided, based on the aforementioned HIFU device, comprising the following steps:

[0061] A focused ultrasound trigger signal is sent to the focused ultrasound device, which is used for focusing control. After receiving the focused ultrasound trigger signal, the focused ultrasound device returns a radio frequency energy start signal to the time synchronization controller, performs focusing control according to the focused ultrasound trigger signal, and returns a radio frequency energy end signal to the time synchronization controller after the ultrasound pulse release ends.

[0062] A motion control trigger signal is sent to the motion control device, which is used to perform motion control. When the motion control device receives the motion control trigger signal, it returns a motion start signal to the time synchronization controller, performs motion control according to the motion control trigger signal, and returns a motion end signal to the time synchronization controller after the movement ends.

[0063] An imaging ultrasound trigger signal is sent to the imaging ultrasound device, which is used for image acquisition control. The transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal are set to have a time difference, which can be kept at a fixed time difference. After receiving the imaging ultrasound trigger signal, the imaging ultrasound device returns an ultrasound image acquisition start signal to the time synchronization controller, performs image acquisition control according to the imaging ultrasound trigger signal, and returns an ultrasound image acquisition end signal to the time synchronization controller after the image acquisition ends.

[0064] Specifically, the time synchronization controller can synchronously control the motion control device, imaging ultrasound device, and focused ultrasound device according to two time sequences. One time sequence is: motion-emission energy-motion-emission energy-…, which repeats cyclically, that is, sequentially outputting motion control trigger signals and focused ultrasound trigger signals in a loop, controlling the focused ultrasound device and motion control device to perform operations cyclically. For example, in one work cycle, the focused ultrasound device is controlled to focus first, then the motion control device is controlled to move, and then in the next work cycle, the focused ultrasound device is controlled to focus first, then the motion control device is controlled to move. The other time sequence is: image ultrasound-image ultrasound-image ultrasound-…, that is, continuously cyclically outputting image ultrasound trigger signals, controlling the image ultrasound device to perform operations. For example, in one work cycle, the image ultrasound device is controlled to continuously perform multiple image acquisitions. The time sequence is set by the time synchronization controller so that the focused ultrasound device and the imaging ultrasound device do not work simultaneously. For example, at the beginning of the work cycle, the focused ultrasound device performs a pulse release operation, and then controls the motion control device and the imaging ultrasound device to operate for the remainder of the work cycle. By using a time synchronization controller to synchronously control the operation of the motion control device, the imaging ultrasound device, and the focused ultrasound device, it is possible to perform ultrasound pulse processing and image acquisition on different areas of the cavity to be treated separately, which facilitates unified management and maximizes the ablation efficiency.

[0065] In one embodiment, the imaging ultrasound device includes an imaging ultrasound host and an imaging ultrasound probe, wherein the imaging ultrasound host is connected to a time synchronization controller and the imaging ultrasound probe. The imaging ultrasound host receives an imaging ultrasound trigger signal sent by the time synchronization controller, and controls the imaging ultrasound probe to perform image acquisition operations upon receiving the imaging ultrasound trigger signal.

[0066] In one embodiment, the focused ultrasound device includes a radio frequency (RF) power source and a focused ultrasound transducer, wherein the RF power source is connected to a time synchronization controller and the focused ultrasound transducer. The RF power source receives a focused ultrasound trigger signal sent by the time synchronization controller and releases a high-intensity focused ultrasound pulse upon receiving the focused ultrasound trigger signal.

[0067] In one embodiment, the motion control device includes a motion controller and a motion mechanism. The motion controller is connected to a time synchronization controller and the motion mechanism, which controls the movement of the focused ultrasound transducer. The motion controller receives a motion control trigger signal from the time synchronization controller and, upon receiving the trigger signal, controls the motion mechanism to move the focused ultrasound transducer once. Alternatively, the imaging ultrasound probe can be fixedly mounted to the focused ultrasound transducer, so that the imaging ultrasound probe moves along with the focused ultrasound transducer, making it easier for the imaging ultrasound probe to acquire images of the target area of ​​the focused ultrasound transducer.

[0068] Further, in one embodiment, the radio frequency energy source controls the focused ultrasound transducer to release a high-intensity focused ultrasound pulse once within a working cycle based on a focused ultrasound trigger signal; the motion controller controls the motion mechanism to move the focused ultrasound transducer once within a working cycle based on a motion control trigger signal; and the imaging ultrasound host controls the imaging ultrasound probe to perform more than two image acquisitions within a working cycle based on an imaging ultrasound trigger signal. Specifically, after controlling the focused ultrasound transducer to release a high-intensity focused ultrasound pulse once within a working cycle, the motion mechanism is controlled to move once to release an ultrasound pulse to the next area to be processed. After the focused ultrasound transducer releases a high-intensity focused ultrasound pulse, the imaging ultrasound probe is controlled to perform multiple image acquisitions within the same working cycle, for example, three image acquisitions. The time for the imaging ultrasound probe to perform image acquisitions may coincide with or not coincide with the movement time of the motion mechanism.

[0069] Specifically, in one embodiment, after receiving a focused ultrasound trigger signal, the radio frequency (RF) energy source returns an RF energy start signal to the time synchronization controller and controls the focused ultrasound transducer to release ultrasound pulses. After the ultrasound pulse release ends, it also returns an RF energy end signal to the time synchronization controller. Upon receiving a motion control trigger signal, the motion controller returns a motion start signal to the time synchronization controller and controls the motion mechanism to move. After the movement ends, it returns a motion end signal to the time synchronization controller. Upon receiving an imaging ultrasound trigger signal, the imaging ultrasound host returns an ultrasound image acquisition start signal to the time synchronization controller and controls the imaging ultrasound probe to acquire images. After the image acquisition ends, it returns an ultrasound image acquisition end signal to the time synchronization controller.

[0070] In this embodiment, before and after performing their respective operations, the radio frequency energy source, motion controller, and imaging ultrasound host also send corresponding start and end signals to the time synchronization controller, so that the time synchronization controller can know the working status of the radio frequency energy source, motion controller, and imaging ultrasound host.

[0071] It is understood that the specific durations of the focused ultrasound trigger signal, motion control trigger signal, and imaging ultrasound trigger signal, as well as the time intervals between the signals, are not unique. In one embodiment, the duration of the imaging ultrasound trigger signal refers to the time it takes for imaging ultrasound to acquire one frame of an image, which is 0.1-10.0 ms, with a frame rate of 20-50 Hz. Further, in one embodiment, the duration of the focused ultrasound trigger signal refers to the time it takes to release one high-intensity focused ultrasound pulse, which is 1-20 ms; the duration of the motion control trigger signal refers to the time it takes to perform one movement, which is 20-500 ms.

[0072] In one embodiment, the time interval between two focused ultrasound trigger signals is 50–500 ms. Furthermore, in one embodiment, the time interval between the start time of the imaging ultrasound trigger signal and the start time of the focused ultrasound trigger signal is 5 ms. Specifically, the time interval from the start time of the last imaging ultrasound trigger signal of the previous work cycle to the start time of the focused ultrasound trigger signal of the current work cycle is 5 ms.

[0073] The aforementioned synchronous control method for high-intensity focused ultrasound equipment synchronously controls the operation of the motion control device, the imaging ultrasound device, and the focused ultrasound device by sending corresponding signals respectively, and ensures that the imaging ultrasound device and the focused ultrasound device do not work at the same time and maintain a fixed time difference, thereby avoiding the transducer of the focused ultrasound device from affecting the monitoring effect of the imaging ultrasound device 300.

[0074] In one embodiment, the synchronous control method for a high-intensity focused ultrasound device further includes: acquiring the imaging ultrasound mode of the imaging ultrasound device; and when the imaging ultrasound mode of the imaging ultrasound device is in the imaging ultrasound mode with a region of interest, adjusting the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

[0075] The imaging ultrasound device 300 possesses multiple imaging ultrasound modes, such as standard B-mode, color Doppler mode, and elastography mode. Understandably, the observational information obtainable from the ultrasound images acquired by the imaging ultrasound device 300 based on the imaging ultrasound trigger signal varies depending on the mode. For example, in standard B-mode, the ultrasound image has a single color and limited information, only a visual color change; further human judgment may be needed to determine the extent of tissue changes. In color Doppler mode, the ultrasound image can observe changes in blood vessels or tumors in dangerous areas of the organ treated by high-intensity focused ultrasound pulses, and color can be used to display changes in tissue movement in the treated area. In elastography mode, the ultrasound image can observe changes in tissue rigidity within the area treated by high-intensity focused ultrasound pulses to determine the success of the treatment.

[0076] Furthermore, the switching of different imaging ultrasound modes of the imaging ultrasound device 300 can be performed in a manner commonly used by those skilled in the art. For example, the imaging ultrasound host 310 can adjust the probe scanning parameters (e.g., frequency or beamforming method) of the imaging ultrasound probe 320 and the algorithm inside the imaging ultrasound host 310 according to the imaging ultrasound mode selected by the user, thereby realizing the switching of different imaging ultrasound modes of the imaging ultrasound device 300, which will not be elaborated here.

[0077] It is understandable that, in order to achieve accurate monitoring of the treatment process, ultrasound images need to be acquired within a precise timeframe after the high-intensity focused ultrasound pulse is emitted. Therefore, while the time synchronization controller 100 synchronously controls the operation of the motion control device 200, the imaging ultrasound device 300, and the focused ultrasound device 400, the high-intensity focused ultrasound pulse may also be displayed in the ultrasound images acquired by the imaging ultrasound device 300, such as... Figure 4 As shown. However, when the imaging ultrasound device 300 is in imaging ultrasound mode with a region of interest (ROI), the high-intensity focused ultrasound pulse may cause ripple interference due to the sensitivity of the ROI's observation information, leading to distortion of the ultrasound image in the ROI. Therefore, when the imaging ultrasound device 300 is in imaging ultrasound mode with a ROI, the display position of the high-intensity focused ultrasound pulse in the ultrasound image must be controlled to be outside the ROI, such as... Figure 5 As shown, this is to avoid ripple interference caused by high-intensity focused ultrasound pulses.

[0078] Specifically, the imaging ultrasound device 300 acquired by the time synchronization controller 100 has an imaging ultrasound mode with a region of interest (ROI), which can be a color Doppler mode or an elastography mode. Furthermore, the time synchronization controller 100 is also used to adjust the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal, so that the high-intensity focused ultrasound pulse is displayed outside the ROI in the ultrasound image. The method of adjusting the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal can be determined according to the actual situation. For example, in one embodiment, to ensure real-time monitoring, the time synchronization controller 100 sends a real-time imaging ultrasound trigger signal to the imaging ultrasound host 310, and then adjusts the time difference according to the actual position of the ROI, advancing or delaying the release of the focused ultrasound trigger signal, so that the high-intensity focused ultrasound pulse is displayed outside the ROI in the ultrasound image. In another embodiment, to control the treatment effect, the time synchronization controller 100 sends a focused ultrasound trigger signal to the radio frequency energy source 410 according to a set frequency, and then adjusts the time difference according to the actual position of the ROI, i.e., advancing or delaying the imaging ultrasound trigger signal.

[0079] To facilitate a better understanding of the high-intensity focused ultrasound equipment and its synchronous control method described above, a detailed explanation is provided below with reference to specific embodiments.

[0080] High-intensity focused ultrasound (HIFU) technology is characterized by its non-invasiveness, effectiveness, and safety. For example, HIFU hyperthermia is a treatment method that rapidly increases the temperature of tissue in the focal area, causing thermal coagulation damage. After HIFU hyperthermia treatment, the tissue is thermally coagulated and left at a distance, where it is slowly absorbed over months or even years. This method utilizes the thermal effect of HIFU to achieve targeted therapy outside the body.

[0081] Furthermore, high-intensity focused ultrasound (HIFU) can also cause mechanical damage to target tissue. Specifically, this technique rapidly boils the liquid in the focal region; the bursting of bubbles from this boiling action can break down and tear the tissue in the target area. Under well-controlled conditions, the tissue in this area will be broken down until no intact cells remain. The tissue in the target area treated by this technique will become a milky liquid, hence the process can also be called tissue emulsification. For some therapeutic applications, tissue emulsification may be more advantageous than thermal damage because the liquefied volume produced by tissue emulsification is easier and faster to remove or be absorbed by the body compared to the solid volume produced by thermal coagulation.

[0082] The movement of the focal point can be achieved in two ways: 1. For phased array transducers, this can be achieved by changing the phase of each channel; 2. For single-channel transducers, it can be achieved by moving the entire transducer. Compared to the second method, the first method can achieve higher speeds, but its accuracy is lower, and it is easily affected by environmental factors and refraction and reflection during sound wave transmission. Phased array transducers also have higher equipment requirements and lower unit output energy. Furthermore, for phased array transducers, once the position and focal point are determined, the ultrasonic wave transmission trajectory cannot be changed. The disadvantage of the second method is that its focal point movement requires the cooperation of external mechanisms.

[0083] To ensure safety, the interval between energy pulses must not be shorter than a fixed time interval. When the time is shorter than the predetermined interval, the system will wait for a certain period until the time interval between pulses meets the requirements. Furthermore, systems using hardware-based mobile transducers can utilize robots with higher degrees of freedom (four degrees of freedom or more) to move the transducer focus while altering the ultrasonic wave transmission path. This reduces the side effects of high-energy focused ultrasound and allows for path optimization in specific locations (such as when skeletal obstruction occurs).

[0084] To achieve accurate monitoring of the treatment process, ultrasound images need to be acquired within a precise timeframe after the high-energy focused ultrasound (HIFU) emission. If this time interval is too short, the HIFU imaging will be affected by ripple interference. If the time interval is too long, the cavitation bubble clusters generated by the cavitation effect cannot be captured, making accurate monitoring of the imaging ultrasound difficult. To maximize efficiency while achieving safe and effective energy and motion control, and balancing the monitoring required for treatment, the synchronization between the HIFU and the motion controller needs to be controlled within 1 ms.

[0085] Based on this, this application provides a high-intensity focused ultrasound device and its synchronous control method, wherein the high-intensity focused ultrasound device is as follows: Figure 2 As shown, the motion mechanism moves the transducer at high speed, and the time synchronization controller controls the relative time between the motion controller, image ultrasound, and energy ultrasound in real time to achieve the maximum ablation efficiency while ensuring good monitoring results.

[0086] The time sequence for synchronization control by the time synchronization controller consists of two parts:

[0087] A: Motion - Energy Emission - Motion - Energy Emission - ... (repeatedly, around 10Hz);

[0088] B: Image ultrasound - Image ultrasound - Image ultrasound - ... (around 40Hz).

[0089] In typical systems, these two time series are independent of each other. Therefore, there are situations where energy ultrasound and imaging ultrasound are initiated simultaneously, leading to image interference. This application aims to coordinate the timing of these three processes to balance image independence with the efficiency of motion and ablation. Figure 3 The diagram shows the timing control of a high-intensity focused ultrasound (HIFU) device. The image sequence acquisition time is approximately 1 ms, and the image acquisition frequency is approximately 20–50 Hz. The radiofrequency energy pulse duration varies from 1 to 20 ms; the motion time varies from 20 to 500 ms. The duty cycle (the time between two energy pulses) is energy-dependent and is controlled within 50–500 ms. The time interval between the image ultrasound start signal and the radiofrequency energy start signal should be controlled within approximately 5 ms, and adjustments should be made according to actual conditions.

[0090] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0091] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A high-intensity focused ultrasound device, characterized in that, It includes a time synchronization controller, a motion control device, an imaging ultrasound device, and a focused ultrasound device, wherein the time synchronization controller is connected to the motion control device, the imaging ultrasound device, and the focused ultrasound device; The time synchronization controller is used to send motion control trigger signals to the motion control device, focused ultrasound trigger signals to the focused ultrasound device, and imaging ultrasound trigger signals to the imaging ultrasound device. The transmission times of the focused ultrasound trigger signals and the imaging ultrasound trigger signals are set to have a time difference. The time synchronization controller synchronously controls the motion control device, the imaging ultrasound device, and the focused ultrasound device according to two time sequences, and the focused ultrasound device and the imaging ultrasound device do not operate simultaneously. One of the two time sequences is used to sequentially output the motion control trigger signals and the focused ultrasound trigger signals in a loop to control the focused ultrasound device and the motion control device to perform operations alternately. The other of the two time sequences is used to continuously and cyclically output the imaging ultrasound trigger signals to control the imaging ultrasound device to perform operations. The motion control device is used to return a motion start signal to the time synchronization controller when it receives the motion control trigger signal, perform motion control according to the motion control trigger signal, and return a motion end signal to the time synchronization controller after the movement ends. The focused ultrasound device is used to return a radio frequency energy start signal to the time synchronization controller after receiving the focused ultrasound trigger signal, perform focusing control according to the focused ultrasound trigger signal, and return a radio frequency energy end signal to the time synchronization controller after ending the ultrasound pulse release. The imaging ultrasound device is used to return an ultrasound image acquisition start signal to the time synchronization controller after receiving an imaging ultrasound trigger signal, perform image acquisition control according to the imaging ultrasound trigger signal, and return an ultrasound image acquisition end signal to the time synchronization controller after ending image acquisition.

2. The high-intensity focused ultrasound device according to claim 1, characterized in that, When the imaging ultrasound device is in imaging ultrasound mode with a region of interest, the time synchronization controller is also used to adjust the time difference between the transmission times of the focused ultrasound trigger signal and the imaging ultrasound trigger signal, so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

3. The high-intensity focused ultrasound device according to claim 1, characterized in that, The imaging ultrasound device includes an imaging ultrasound host and an imaging ultrasound probe, wherein the imaging ultrasound host is connected to the time synchronization controller and the imaging ultrasound probe.

4. The high-intensity focused ultrasound device according to claim 3, characterized in that, The focused ultrasound device includes a radio frequency energy source and a focused ultrasound transducer, wherein the radio frequency energy source is connected to the time synchronization controller and the focused ultrasound transducer.

5. The high-intensity focused ultrasound device according to claim 4, characterized in that, The motion control device includes a motion controller and a motion mechanism. The motion controller is connected to the time synchronization controller and the motion mechanism. The motion mechanism is used to control the movement of the focused ultrasound transducer.

6. The high-intensity focused ultrasound device according to claim 5, characterized in that, The radio frequency energy source controls the focused ultrasound transducer to release a high-intensity focused ultrasound pulse once within the working cycle according to the focused ultrasound trigger signal; the motion controller controls the motion mechanism to move the focused ultrasound transducer once within the working cycle according to the motion control trigger signal; the imaging ultrasound host controls the imaging ultrasound probe to perform more than two image acquisitions within the working cycle according to the imaging ultrasound trigger signal.

7. The high-intensity focused ultrasound device according to any one of claims 1-6, characterized in that, The duration of the imaging ultrasound trigger signal refers to the time it takes for the imaging ultrasound to acquire one frame of an image, which is 0.1-10.0ms, with a frame rate of 20-50Hz.

8. The high-intensity focused ultrasound device according to any one of claims 1-6, characterized in that, The duration of the focused ultrasound trigger signal refers to the time for releasing one high-intensity focused ultrasound pulse, which is 1~20ms; the duration of the motion control trigger signal refers to the time for performing one movement, which is 20~500ms.

9. The high-intensity focused ultrasound device according to any one of claims 1-6, characterized in that, The time interval between the two focused ultrasound trigger signals is 50~500ms.

10. The high-intensity focused ultrasound device according to any one of claims 1-6, characterized in that, The time interval between the start time of the imaging ultrasound trigger signal and the start time of the focused ultrasound trigger signal is 5ms.

11. A synchronous control method for a high-intensity focused ultrasound (HIFU) device, implemented based on the HIFU device according to any one of claims 1-10, comprising the following steps: A focused ultrasound trigger signal is sent to the focused ultrasound device, and the focused ultrasound trigger signal is used by the focused ultrasound device to perform focusing control; after receiving the focused ultrasound trigger signal, the focused ultrasound device returns a radio frequency energy start signal to the time synchronization controller, performs focusing control according to the focused ultrasound trigger signal, and returns a radio frequency energy end signal to the time synchronization controller after ending the ultrasound pulse release. A motion control trigger signal is sent to the motion control device, which is used by the motion control device to perform motion control; when the motion control device receives the motion control trigger signal, it returns a motion start signal to the time synchronization controller, performs motion control according to the motion control trigger signal, and returns a motion end signal to the time synchronization controller after the movement ends. An imaging ultrasound trigger signal is sent to the imaging ultrasound device, which is used by the imaging ultrasound device to control image acquisition; wherein, the transmission time of the focusing ultrasound trigger signal and the imaging ultrasound trigger signal is set to have a time difference; after receiving the imaging ultrasound trigger signal, the imaging ultrasound device returns an ultrasound image acquisition start signal to the time synchronization controller, performs image acquisition control according to the imaging ultrasound trigger signal, and returns an ultrasound image acquisition end signal to the time synchronization controller after ending image acquisition.

12. The synchronous control method for a high-intensity focused ultrasound device according to claim 11, characterized in that, The method further includes: Acquire the imaging ultrasound mode of the imaging ultrasound device; When the imaging ultrasound mode of the imaging ultrasound device is in the imaging ultrasound mode with a region of interest, the time difference between the transmission time of the focused ultrasound trigger signal and the imaging ultrasound trigger signal is adjusted so that the display position of the high-intensity focused ultrasound pulse in the ultrasound image is outside the region of interest.

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