Diagnosis and treatment integrated three-dimensional area array ultrasonic transducer treatment system and use method thereof

Abstract

The invention discloses a diagnosis and treatment integrated three-dimensional area array ultrasonic transducer treatment system and a use method thereof. The system integrates five functional modules of ultrasonic diagnosis, treatment, control, monitoring and movement. The focal position or the focal region size of a focused ultrasonic signal in a target tissue region can be dynamically adjusted through a three-dimensional area array ultrasonic transducer serving as a phased array; the double-frequency focusing can be realized, each vibration element can be set to have different bandwidths, two modes of treatment and B ultrasonic are realized at the same time, and the treatment of a target area is realized by adopting a constant temperature or an adjustable temperature; the control module is used as a core center to coordinate linkage operation of the diagnosis and treatment module, synchronously receive heart rate, blood pressure and other vital sign data fed back by the physiological index monitoring module, and dynamically optimize treatment parameters according to the data; the motion module provides a multi-dimensional positioning function, has the technical advantages of diagnosis and treatment synchronization, parameter adaptive adjustment, targeted dynamic tracking and the like, and is suitable for precise ultrasonic treatment and real-time curative effect evaluation of human body and animal models.

Description

Technical Field

[0001] The present invention relates to the technical field of ultrasonic imaging and treatment, in particular to a three-dimensional array ultrasonic transducer treatment system for integrated diagnosis and treatment and its usage method. Background Art

[0002] With the improvement of living standards, the obesity rate and the aging rate are also rising continuously. Chronic metabolic diseases such as diabetes, fatty liver, and hypertension pose a severe challenge to public health. Diabetes-related complications and hypertension-related cardiovascular and cerebrovascular diseases have become important factors causing human death. Drug treatment often has side effects and is ineffective for some patients; diet and exercise therapies require the self-discipline of patients and are prone to recurrence of the disease; although organ transplantation, gene therapy, etc. have good effects, they are expensive and difficult to popularize. Ultrasound can cause different responses in the body by using its biological effects. It has been found that ultrasound can regulate nerve activity through mechanical effects and treat diseases such as diabetes and hypertension.

[0003] However, there is currently no device for precise ultrasonic stimulation of nerves. Existing ultrasonic devices also mostly focus on single functions, either diagnosis or treatment, lacking integrated diagnosis and treatment devices that combine the two. At the same time, existing treatment methods are mostly doctor-held treatments, while nerve regulation requires high precision. Therefore, it is necessary to get rid of human hands and use a high-precision mechanical control method for treatment. In addition, the imbalance of medical resources has led to a shortage of treatment resources in grass-roots communities. Therefore, new devices should have a lower threshold to cover more patients.

[0004] Currently, the obesity rate and the aging rate are rising continuously. Chronic metabolic diseases such as diabetes, fatty liver, and hypertension pose a severe challenge to public health. Diabetes-related complications and hypertension-related cardiovascular and cerebrovascular diseases have become important factors causing human death. Drug treatment often has side effects and is ineffective for some patients; diet and exercise therapies require the self-discipline of patients and are prone to recurrence of the disease; although organ transplantation, gene therapy, etc. have good effects, they are expensive and difficult to popularize. As a non-invasive treatment means, ultrasound shows great potential in the treatment of metabolic diseases. By stimulating targeted organs and tissues, it can treat such diseases well. However, through the research of the inventor of the present invention, it is found that the existing ultrasonic treatment devices still have the following deficiencies: First, diagnosis and treatment are often out of sync. The mode of first positioning and then stimulating often leads to inaccurate focusing and a decline in the treatment effect; Second, the access threshold is relatively high. For the positioning of nerves, doctors with relatively high professional capabilities are required. Even ordinary doctors are difficult to perform precise positioning, resulting in a decline in the curative effect; Third, most of the transducers used are single array elements, and the focal point position and the like cannot be adjusted according to actual needs; 4. Handheld treatment may result in inaccurate positioning and poor treatment effect due to inevitable hand shaking.

[0005] Therefore, in view of the defects of existing instruments and equipment, it is necessary to design an intelligent mechanically controlled high-precision diagnosis and treatment integrated ultrasonic treatment device. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide a diagnosis and treatment integrated three-dimensional array ultrasonic transducer and its system. This method uses the three-dimensional array ultrasonic transducer to achieve the working state of alternating and intermittent ultrasonic diagnosis and ultrasonic treatment under the action of a control signal.

[0007] To achieve the above purpose, the present invention provides the following technical solutions: The diagnosis and treatment integrated three-dimensional array ultrasonic transducer treatment system provided by the present invention includes a three-dimensional array ultrasonic transducer, a control module, and a motion module; The three-dimensional array ultrasonic transducer is a phased array ultrasonic transducer; Further, the phased array ultrasonic transducer is composed of 64 to 512 array elements arranged in a planar array, and the size of each array element is 10mm×10mm; Further, each array element of the transducer communicates independently with the control module through a signal transmission unit, receives control information, dynamically and precisely adjusts the phase delay to achieve beam deflection and focusing, and further adjusts the focal point position and focal region size; Further, each transducer array element in the three-dimensional array ultrasonic transducer has a bandwidth in its operating frequency. According to the actual situation, the center frequency range is 0.5 - 7.5MHz, and the bandwidth range is ±25%. That is, when the center frequency is 4MHz, the actual operating frequency range covers 3 - 5MHz. During the diagnosis and treatment process, the higher value within the operating frequency bandwidth of the transducer will be used as the diagnostic operating frequency, that is, for B-mode ultrasound imaging, so as to achieve a better imaging effect; the best treatment frequency within the operating frequency bandwidth of the transducer will be used as the treatment operating frequency, that is, for ultrasonic treatment; Further, the three-dimensional array ultrasonic transducer can be divided into two regions with equal areas, which emit ultrasonic waves of different frequencies respectively to achieve dual-frequency focused ultrasound stimulation of the target area.

[0008] The control module includes a parameter setting control unit and a mode control unit; Further, the parameter setting control unit is used to adjust the working parameters of the ultrasonic transducer in real time; Further, the mode control unit is used to control the working mode of the ultrasonic transducer. The working modes include a treatment mode and a B-mode ultrasound mode. The ultrasonic treatment mode and the ultrasonic monitoring mode work alternately at intervals under the action of a control pulse signal; Furthermore, the treatment modes include ultrasonic regulation and ultrasonic hyperthermia treatment; The ultrasonic regulation utilizes the ultrasonic mechanical effect, and stimulates the target area by using the acoustic radiation force to achieve treatment without causing significant temperature rise in the target area; The ultrasonic hyperthermia treatment uses the ultrasonic thermal effect to heat-treat the target area, and can achieve hyperthermia within the range of 37°C to 65°C.

[0009] The integrated diagnosis and treatment three-dimensional matrix ultrasonic transducer treatment system further includes an ultrasonic monitoring module, an ultrasonic treatment module and a motion module; Furthermore, the ultrasonic monitoring module includes a control module, a signal transmission unit, a transmitting unit, and a signal receiving unit; The control module is responsible for sending control signals to regulate the parameters of the imaging ultrasound, and is also responsible for processing the received echo signals and forming image data; The signal transmission unit is responsible for transmitting independent control information to each element and feeding back the information received by each element to the control module; The transmitting unit emits corresponding imaging ultrasound signals into space according to the control information; The signal receiving unit collects and receives the ultrasonic echo signals containing three-dimensional space information, performs preprocessing, and transmits them to the signal transmission unit.

[0010] Furthermore, the ultrasonic treatment module includes a control module, a signal transmission unit, an excitation unit, and a transmitting unit; The control module is responsible for sending control signals to regulate the parameters of the treatment ultrasound; The signal transmission unit is responsible for transmitting independent control information to each excitation unit; The excitation unit amplifies the control signal by excitation to form a corresponding drive signal and transmits it to the transmitting unit; The transmitting unit emits ultrasonic waves to the target area for treatment according to the drive signal.

[0011] The ultrasonic treatment method provided by the present invention using the above integrated diagnosis and treatment ultrasonic treatment system includes the following steps: Step 1: Determine the patient information and confirm the treatment parameters, etc.; Step 2: Use the monitoring mode for imaging, confirm the treatment target area, and control the transducer to move to the treatment position; Step 3: Treat the patient. Under the action of the control timing signal, start the mode of alternating treatment and imaging monitoring, and obtain real-time B-ultrasound image data of the target area while irradiating the target area with ultrasound; Step 4: After the treatment is completed, transfer the corresponding data to the control module, and store the relevant diagnosis and treatment data after obtaining the informed consent of the patient.

[0012] The beneficial effects of the present invention are as follows: The present invention provides a three-dimensional matrix ultrasonic transducer treatment and its system for integrated diagnosis and treatment, which system includes an ultrasonic diagnosis module, an ultrasonic treatment module, a control module, and a motion module: The ultrasonic diagnosis module is communicatively connected to the control module, provides B-ultrasound image data, and identifies the target area; The ultrasonic treatment module is communicatively connected to the control module, responds to the control signal, and emits ultrasonic waves towards the target; The control module is communicatively connected to the ultrasonic treatment module and the diagnosis module, controls the operation of the ultrasonic treatment module and the diagnosis module, receives information from the ultrasonic diagnosis module, determines the target area according to the diagnosis information, controls the ultrasonic treatment module to perform tracking irradiation on the target area, adjusts the treatment parameters according to the diagnosis and treatment data, etc., and can record the corresponding diagnosis and treatment data at the same time; The motion module can realize the movement of the treatment device to meet the requirements of stimulating and imaging different target areas. The system integrates the ultrasonic diagnosis module, the ultrasonic treatment module, the control module, and the motion module, can adjust the specific structural composition according to the treatment environment, is applicable to humans and other animals, meets professional diagnosis and treatment as well as community-based health management, and can achieve precise and controllable ultrasonic treatment.

[0013] The three-dimensional matrix ultrasonic transducer for integrated diagnosis and treatment provided by the present invention takes into account both imaging and stimulation functions. During neuromodulation, in order to ensure high sound pressure and low damage, a lower duty cycle will be set, and the gap between the emission of therapeutic ultrasonic pulses will be switched to the B-ultrasound mode for imaging the target area. This integrated diagnosis and treatment method provides real-time image data. In the treatment mode, each array adjusts the emission parameters according to the control signal, so that the focus can be changed, thereby realizing tracking stimulation of the target area; In the B-ultrasound mode, all arrays can emit and receive ultrasonic information. Compared with the previous linear array distribution, this matrix imaging can provide more accurate three-dimensional image information, and higher ultrasonic energy can also provide higher imaging quality, thereby reducing the diagnostic difficulty of doctors.

[0014] The present invention moves through a six-degree-of-freedom robotic load device, can achieve precise focused ultrasound treatment, meets the requirements of stimulating different organs and targets, and can perform real-time imaging during the treatment process to improve the treatment accuracy; Based on the database system and the diagnosis system, the device can accurately regulate the treatment parameters based on the existing real-time data.

[0015] Other advantages, objectives, and features of the present invention will be described to some extent in the subsequent specification, and to some extent, will be obvious to those skilled in the art based on the study of the following text, or can be taught from the practice of the present invention. The objectives and other advantages of the present invention can be realized and obtained through the following specification. Brief Description of the Drawings

[0016] To make the objectives, technical solutions and beneficial effects of the present invention clearer, the following drawings are provided for the description of the present invention.

[0017] Figure 1 It is a schematic diagram showing the interaction of each functional module.

[0018] Figure 2 It is a schematic diagram of the control module responsible for controlling the overall system.

[0019] Figure 3 It is a schematic overview of the specific treatment.

[0020] Figure 4 It is the specific structure of the ultrasonic robot responsible for implementing the treatment.

[0021] Figure 5 It is the flowchart of the entire treatment cycle during treatment.

[0022] Figure 6 It is the timing diagram of the interval control pulse between the treatment mode and the B-mode ultrasound mode.

[0023] Figure 7 It is a schematic diagram of the handheld integrated diagnosis and treatment ultrasonic treatment device.

[0024] 1: Central processing system; 2: Display screen; 3: Other parameter display screen; 4: Workbench; 5: Computer chassis; 6: Information interaction pipeline; 7: Six-degree-of-freedom motion robot; 8: Treatment bed; 9: Distribution of three-dimensional matrix ultrasonic transducer array elements; 10: Fixed position of three-dimensional matrix ultrasonic transducer. Detailed Embodiment

[0025] The following further describes the present invention in conjunction with the drawings and specific embodiments, so that those skilled in the art can better understand the present invention and be able to implement it, but the embodiments cited do not limit the present invention.

[0026] Embodiment 1 As Figure 1 shown, the integrated diagnosis and treatment three-dimensional matrix ultrasonic transducer system provided in this embodiment includes a control module, an ultrasonic treatment module, an ultrasonic diagnosis module and a motion module; The control module controls the three-dimensional matrix ultrasonic transducer through a signal transmission unit and controls the motion of the motion module to realize the movement of the device. At the same time, the control module also receives the diagnosis and treatment data from other modules, establishes a data center, and monitors the whole process of diagnosis and treatment; The control module includes a parameter setting control unit and a mode control unit; The parameter setting and control unit is used to set the working parameters of the ultrasonic transducer, and these parameters include: working frequency, acoustic power, duty cycle, pulse repetition frequency, single treatment time, the number and distribution of the array elements excited in response in the ultrasonic transducer, etc.; The mode control unit is used to control the working mode of the ultrasonic transducer. The working modes include an ultrasonic treatment mode and an ultrasonic imaging monitoring mode. The ultrasonic treatment mode and the ultrasonic imaging monitoring mode work alternately at intervals under the action of a control pulse signal; The treatment mode includes ultrasonic regulation and ultrasonic hyperthermia treatment; The ultrasonic regulation utilizes the ultrasonic mechanical effect and uses the acoustic radiation force to stimulate the target area to achieve treatment; The ultrasonic hyperthermia treatment utilizes the ultrasonic thermal effect to achieve heating within the range of 37°C to 65°C in the target area, so as to perform corresponding treatment; The three-dimensional matrix transducer is composed of 64 to 512 array elements with a size of 10mm×10mm arranged in a matrix form; The three-dimensional matrix transducer is a phased array ultrasonic transducer. Under the real-time regulation of the control module, the phase, amplitude and delay parameters of each array element can be dynamically adjusted to achieve three-dimensional spatial positioning of the focal point position and precise regulation of the focal region geometric parameters in the target area; The working frequency of the transducer array element has a certain bandwidth. The center frequency is determined according to the actual application scenario, ranging from 0.5 to 7.5 MHz, and the bandwidth range is ±25%. The following examples are provided: The center frequency of the low-frequency transducer is 1 MHz, and the working frequency adjustment range is 0.75 - 1.25 MHz; The center frequency of the medium-frequency transducer is 3 MHz, and the working frequency adjustment range is 2.25 - 3.75 MHz; The center frequency of the high-frequency transducer is 6 MHz, and the working frequency adjustment range is 4.5 - 7.5 MHz.

[0027] During the diagnosis and treatment process, the higher value within the working frequency bandwidth of the transducer will be used as the diagnostic working frequency, that is, for B-ultrasound imaging, so as to achieve a better imaging effect; the optimal treatment frequency within the working frequency bandwidth of the transducer will be used as the treatment working frequency, that is, for ultrasonic treatment; The three-dimensional matrix ultrasonic transducer can be divided into two regions with equal areas under the independent control of the channel controller, and emit ultrasonic waves with different frequencies respectively to achieve dual-frequency focused ultrasonic stimulation of the target area.

[0028] The ultrasonic diagnosis module is communicatively connected to the control module, and is used for real-time imaging of the target, providing B-ultrasound image data to the control module; and in response to the control signal of the control module, emitting diagnostic ultrasound to the target area; The ultrasonic treatment module performs tracking irradiation on the target area under the control of the control module, automatically adjusts real-time parameters according to real-time diagnosis data, and feeds back treatment information to the control system.

[0029] The motion module is connected to the control module, controls the spatial position and orientation of the treatment device according to the change of the target area position; performs multi-degree-of-freedom motion in response to the imaging and treatment positioning requirements of different target areas; controls the movement of the treatment device according to the stimulation and imaging requirements of different target areas.

[0030] The control module in this embodiment is used to control the start and stop of the ultrasonic diagnosis module and the treatment module; receive and process the target area positioning data and related image data of the ultrasonic diagnosis module; generate a tracking control instruction according to the target area positioning data, and drive the ultrasonic treatment module to perform targeted irradiation; dynamically adjust the ultrasonic treatment parameters based on the change of real-time diagnosis data, and the parameters include working frequency, sound power, duty cycle, pulse repetition frequency, and single treatment time, etc. The ultrasonic diagnosis module includes a data transmission and storage unit and a motion following unit; The data transmission and storage unit is responsible for the transmission of data information between the diagnosis module and the control module, retains the treatment information of the patient during the treatment, and assists in planning the subsequent treatment plan; The motion following unit can capture the target information in the motion state, achieve accurate and clear imaging through motion compensation, and at the same time transmit the motion information to the control module.

[0031] In this embodiment, the three-dimensional matrix ultrasonic transducer in the ultrasonic diagnosis module can emit and receive ultrasonic information; transmit the relevant information of the reflected ultrasonic wave signal to the central processor through the data transmission interface, and at the same time receive instructions from the control module.

[0032] The ultrasonic treatment module includes a phased array ultrasonic transducer, a driving unit, and a data transmission and processing unit; The phased array ultrasonic transducer is electrically connected to the driving unit, and emits ultrasonic waves from the surface of the transducer by receiving the driving signal; The driving unit is connected to the phased array ultrasonic transducer and the control module, receives the control signal, and sends the driving signal to the transducer; The data transmission and processing unit feeds back the corresponding ultrasonic treatment parameters to the control module; receives the control signal from the control module and transmits it to the driving unit to control the formation of the driving signal.

[0033] As Figure 2 shown, the control module includes a motion control unit, a parameter control unit, a database, a central processing unit, an output control unit, and a personal unit; The motion control unit can output commands to the robotic arm according to the user's control instructions to move the corresponding diagnostic and treatment device. At the same time, the user can select the target area on the display screen. After being calculated by the processor, a signal is output to the robotic arm to automatically control the movement of the device, so that the target area can be imaged in the center of the display screen. This unit processes the data of the pressure sensor and adjusts the motion state to prevent compression injuries; The parameter control unit can control the output parameters of each element of the array transducer; The database is used to store historical data, provide database networking, and interact with other authorized users in terms of data; The central processing unit is used to process various data information to form control information and perform corresponding control on the device; The output control unit can control the output of each element and control the output mode at the same time, and can switch between the imaging mode and the treatment mode; The personal unit is used to integrate and store patient information, implement tracking and evaluate the curative effect, and form a personalized treatment plan to meet the needs of different patients.

[0034] The parameter control unit includes a manual control subunit and an automatic control subunit; The manual control subunit preliminarily sets and manually adjusts the output parameters of the array transducer according to the parameter setting instructions manually input by the user; The automatic control subunit can, as needed, process the feedback physiological indicators and form corresponding control information to automatically control the output parameters.

[0035] The central processing unit includes an image processing subunit, a motion processing subunit, a target following processing subunit, and an output parameter processing subunit; The image processing subunit can calculate and process real-time image data, provide high-quality image data of the moving target and display it; The motion processing subunit processes the user's manual control signal to control the movement of the robotic arm, or automatically calculates and processes according to the target area confirmation result to control the robotic arm to move automatically, ensuring that the target area can be imaged in the center of the display screen; The target following processing subunit adjusts the output parameters of the array transducer, such as phase and other information, according to the motion parameters of the target area feedback by the ultrasonic diagnosis module, so that the focal area always follows the target and covers the entire target area. This unit has a gating function and judges the motion intensity. When the motion speed and amplitude of the target are too high and exceed the following limit of the ultrasonic treatment module, the treatment program will be stopped, and corresponding treatment will be carried out when the motion parameters are within the normal range, such as normal breathing; The output parameter processing subunit mainly processes the data of the instructions related to parameter adjustment during the treatment process, forms a control signal, and controls the device through the parameter control unit.

[0036] As Figure 4 shown, the motion module includes a teach pendant, a drive system, and a six-degree-of-freedom robot; The teach pendant can manually control the movement of the robot and display the coordinates of the transducer, the motion parameters of the robot, etc.; The drive system is connected to the teach pendant, the control module, and the six-degree-of-freedom robot, can receive signals from the teach pendant and the control module, form a drive signal, and control the movement of the robot; The six-degree-of-freedom robot has flexible six-degree-of-freedom three-dimensional motion ability and moves the load ultrasonic treatment equipment accordingly.

[0037] The six-degree-of-freedom robot in this embodiment can complete the device movement program according to the output instruction of the control system; the ultrasonic transducer is fixed on the robot through the transducer fixing device, and the fixing device is detachable from the robot; the ultrasonic transducer adopts an array ultrasonic transducer, which is installed at the top of the robot and can move freely following the robot.

[0038] At the same time, a pressure sensor is also arranged on the six-degree-of-freedom robot, which is used to monitor the magnitude and direction of the pressure acting on the patient's skin surface in real time, avoid causing compression damage to the patient; prevent internal tissue displacement caused by excessive pressure; and can also limit the motion intensity of the motion target with appropriate pressure to improve the accuracy of treatment; The motion module in this embodiment is mainly responsible for receiving information from the control module, moving the ultrasonic transducer to the target area, and implementing feedback on the three-dimensional space coordinates of the ultrasonic transducer.

[0039] The B-ultrasound used in the ultrasonic diagnosis module and the transducer used in the ultrasonic treatment module are the same array transducer, which can image the target and also perform stimulation treatment on the target. For the array transducer, each element is independently controlled, can freely switch between the diagnostic mode and the treatment mode, can realize real-time adjustment of the output phase to change the focal position. In addition, due to independent control, each element of the three-dimensional matrix ultrasonic transducer can arbitrarily adjust the working frequency, and the array ultrasonic can form dual-frequency focusing stimulation, and the frequency difference can be adjusted, facilitating the formation of dual-frequency focusing.

[0040] As Figure 2 and Figure 3 shown, the integrated diagnosis and treatment three-dimensional matrix ultrasonic transducer treatment system provided in this embodiment further includes an ultrasonic treatment bed, a drive module, a database, and a display system; The ultrasonic treatment bed is used for treating patients in a lying position. The driving module is used to drive the ultrasonic transducer. The database is used to interact with other devices for diagnosis and treatment data and store data. The driving module includes a signal receiving unit, an excitation unit, and a driving device. The signal receiving unit can receive adjustment information from the output control module, thereby changing the parameter settings of the excitation unit. The excitation unit can generate an excitation signal and electrically transmit it to the driving device. The driving device is electrically connected to the three-dimensional matrix ultrasonic transducer. After driving and amplifying the excitation signal, it transmits the driving signal to the three-dimensional matrix ultrasonic transducer.

[0041] The database includes a data transmission interface and a storage system. The data transmission interface is used to interact with external device data and with data of other systems inside the device. The storage system can be used to store data, including a historical data center and a personal data center.

[0042] The display system includes an imaging unit, a teach pendant interface, and a parameter display interface. The imaging unit can display B-ultrasound related information, mainly for reading and saving B-ultrasound images and positioning the target area. The teach pendant interface is mainly used to display the data of the motion system, facilitating the control of the motion system for manual movement. The parameter display interface is used to display various other parameters, including the output parameters of the transducer and other related information.

[0043] Embodiment 2 As Figure 5 shown, Figure 5 The flowchart of ultrasonic treatment using the ultrasonic treatment system is shown, which generally includes steps such as preliminary preparation, target area confirmation, parameter confirmation, real-time precise treatment, subsequent treatment planning, and data collection after treatment. This embodiment also provides a method for ultrasonic treatment using the integrated diagnosis and treatment ultrasonic treatment system, including the following steps: Step 1: After starting the treatment, when the patient is ready, the doctor confirms the routine information, selects the treatment target, completes the final confirmation of the target area, and then moves the ultrasonic transducer so that it can cover the irradiation area. Step 2: Determine the treatment parameters and then start the treatment. Step 3: After the treatment is completed, record the real-time treatment data and confirm the further treatment plan. Step 4: After obtaining the informed consent of the patient, store the treatment-related data.

[0044] The display screen of the display system in this embodiment will display real-time B-ultrasound images and other diagnostic information. At the same time, according to the deep learning model, the system will provide reference treatment parameters. The doctor determines the stimulation parameters based on the diagnostic information and system suggestions, adjusts the output parameters of the transducer through the control system, generates a driving signal through the driving system, makes the transducer output ultrasonic waves, and treats the patient. The treatment process is imaged in real time, and the focal region follows the target area to move, realizing precise stimulation. After the treatment is completed, the control module makes a plan for the subsequent treatment plan and stores the treatment data for the convenience of the design of the subsequent treatment plan. After obtaining the informed consent of the patient, the data will be shared or kept confidential.

[0045] The objects that the system provided in this embodiment can be used for treatment include diabetic patients, hypertensive patients, and patients with related complications, but are not limited to this. Other diseases that can be treated by ultrasound, such as arthritis and pain relief, are also included.

[0046] The target area tracking function in this embodiment means that for a moving target, the diagnostic system sends the motion parameters to the control module. After calculation, the control module will generate corresponding instructions to control the emission parameters of the three-dimensional array ultrasonic transducer, thereby forming a moving focus so that the focal region always covers the target area. When the intensity of the movement, such as the speed, exceeds the following limit and the focal region cannot always cover the target area, through the gating system, the treatment will be stopped. The system will automatically judge whether the patient is in a quiet state and whether treatment can be carried out, and treat under suitable circumstances to obtain the best treatment effect.

[0047] The personalized treatment plan in this embodiment includes the treatment course and treatment frequency. After each treatment is completed, the subsequent plan will be adjusted according to the latest physiological image data. The parameters of a single treatment include the working frequency, that is, the main frequency component of the ultrasonic wave during work, the number of vibrations per second; the sound pressure, that is, the pressure difference at a certain point in space before and after the action of the ultrasonic wave; the sound intensity, that is, the ultrasonic energy passing perpendicularly through a unit area per unit time; the pulse repetition frequency, that is, the number of ultrasonic pulses emitted per second, which is the reciprocal of the pulse repetition interval; the duty cycle, that is, the ratio of the time when the ultrasonic signal is at a high level and emits ultrasonic waves to the entire cycle time within a single pulse period; the single treatment time, that is, the duration from the start of the treatment ultrasound to the end of the treatment during a certain treatment; the target area, that is, the target area that needs to receive ultrasonic irradiation determined before the start of the treatment; the difference frequency, that is, when dual-frequency stimulation is used, the difference between two different working frequencies; the motion parameters, that is, the displacement information of the target in the three-dimensional space during the treatment process, including the displacement magnitude, displacement speed, etc. Of course, the parameters of a single treatment are not limited to this.

[0048] Figure 3 Shown is a schematic diagram of a patient receiving treatment and the workbench for a doctor to perform the treatment. The patient can lie comfortably on the treatment bed. The doctor can use the teaching pendant to manipulate the movement of the ultrasonic robot, complete target positioning, and treat the patient. During the treatment process, real-time imaging will be performed to provide real-time feedback of the patient's information. At the same time, with the patient's consent, the data will be retained for optimizing the machine learning model.

[0049] Figure 4 Shown is a schematic diagram of the ultrasonic robot. This robot has six degrees of freedom and can achieve free movement in three-dimensional space. There is a pressure sensor inside the robot to monitor the pressure exerted by the top of the robot on other objects. 6 is the support arm of the robot, which is used to carry the robot itself and other devices and provide support. 7 is a rotatable joint, which is used to improve the flexibility of the robot's movement in three-dimensional space. 8 is a three-dimensional matrix ultrasonic transducer, which is fixed at the top of the robot and can simultaneously perform imaging and treatment. 9 is the surface of the enlarged array transducer. First, the entire surface is concave and has a focusing function. Second, the array consists of 256 elements arranged in a 16×16 pattern, and each element is controlled by a separate channel. 10 is the channel for signal transmission, which also includes the channels for controlling each element, shown only schematically. The doctor (user) can control the movement of the robotic arm through the teaching pendant and move it near the treatment area. After further confirming the target area, as long as the target area is selected on the image display interface, the control system will send a control signal to make the robot move to achieve precise positioning. At this time, the target area image will be located in the center of the display screen, and the focal region of the ultrasonic transducer will completely cover the target area.

[0050] Figure 4The enlarged three-dimensional array ultrasonic transducer shown has each element under independent channel control, receiving information from the control system and being able to control the operating frequency, phase, duty cycle, sound intensity, pulse repetition frequency, on / off state, mode selection, etc. Here, the on / off state refers to controlling the ultrasonic transducer elements to emit ultrasonic waves and stop emitting ultrasonic waves. Mode selection refers to controlling the transducer elements to perform imaging or treatment. In the B-mode ultrasound, it is for imaging, and in the treatment mode, ultrasonic stimulation will be applied to the target. During the actual treatment process, by adjusting the operating frequency, different frequency stimulations can be achieved, or dual-frequency stimulation can be carried out. During the treatment process, according to the real-time acquired motion information of the target area and under the control of the control system, each element adjusts the phase, etc. to achieve the displacement of the focus, so as to ensure following the target and the focal region can always cover the target area. The principle of real-time imaging during treatment is that during each pulse period of the therapeutic ultrasound, there is a low-level state where no ultrasonic waves are emitted. During this interval, each element will switch to the B-mode ultrasound to achieve real-time imaging during the treatment process. The B-mode ultrasound image formed by this array ultrasound contains three-dimensional information, and at the same time, through ultrasonic ranging, etc., it can real-time feedback the motion of the target area in three-dimensional space. The B-mode ultrasound will transmit this information to the control module. The B-mode ultrasound image has a motion compensation function, which will improve the imaging effect of moving targets. The motion information will be transmitted to the control module but will not be displayed on the display screen. Through the motion compensation function, the image on the display screen is stable.

[0051] As Figure 6 shown, in this embodiment, it is the timing diagram of the interval control pulses for the treatment mode and the B-mode ultrasound. The low-level state of the pulse period of the control pulse signal is set as the B-mode ultrasound, that is, the ultrasonic wave signal emitted by the ultrasonic transducer in this state is used to obtain the B-mode ultrasound imaging image. The high-level state is set as the treatment mode, that is, the ultrasonic wave signal emitted by the ultrasonic transducer in this state is used for ultrasonic treatment. Relative to the treatment mode, the high level represents the normal output of therapeutic ultrasound, and the low level indicates that no therapeutic ultrasound is output. At the same time, during the period when the treatment mode is at the low level, the B-mode ultrasound is turned on. At this time, the ultrasonic waves emitted by the ultrasonic transducer are used for diagnosis to perform B-mode ultrasound imaging on the target.

[0052] The treatment mode can select dual-frequency treatment according to the actual situation, that is, set the difference between two different operating frequencies for ultrasonic treatment. As Figure 7 shown, it is a handheld device. The imaging and other relevant data of this device will be transmitted to the mobile device in real time through means such as Bluetooth, so as to achieve more convenient treatment. At the same time, although this device is handheld, it uses a gooseneck bracket for auxiliary support. After the initial positioning is completed, it can rely on the auxiliary support function of the bracket to avoid the influence of handheld shaking. This device also has functions such as target area tracking, etc. Although the structures are very different, there is no substantial difference.

[0053] In Figure 2 , Figure 2 is a schematic diagram of the central control module. Among them, 1 is a schematic diagram of the central processing system, which realizes functions such as data calculation and storage and is the most core part of the entire device; 2 is a schematic diagram of the display screen, including but not limited to the image display screen, the teach pendant display screen, etc. All data that needs to be displayed will be displayed through the display screen; 3 is a parameter display device, which displays information such as real-time treatment parameters; 4 is a work platform on which users can complete routine operations; 5 is a small chassis containing devices such as the main board, which is used to complete some simple computer operations; 6 is a channel for signal transmission and is a channel for interacting with other modules. Below, the control module will be described starting from four modules.

[0054] During ultrasonic treatment, the treatment parameters are displayed through the display screen, and the control module can regulate the parameters of ultrasonic output. This regulation includes two parts. On the one hand, after deep learning, the control system will provide a reference treatment parameter. The user confirms the treatment parameter according to the reference opinion and controls the transducer to perform ultrasonic treatment. On the other hand, based on the feedback motion information, the control system adjusts the parameters, especially the phase, etc. after calculation and processing to control the focal region to always cover the target area. The control system will also evaluate the patient's state to decide whether to perform treatment. In addition, after each treatment, the control system will provide a personalized diagnosis and treatment plan based on the feedback data such as physiological indicators, and reasonably infer the subsequent treatment plan for the user to refer to.

[0055] During ultrasonic diagnosis, the B-ultrasound image will be displayed on the display screen. Through the motion compensation function, the image is stable and clear. At the same time, the data collected by the B-ultrasound, including the motion information of the target area, will be transmitted to the control module, but only for background calculation to track the target area and will not be displayed.

[0056] The motion module is controlled by the control module and at the same time transmits information such as the spatial position of the transducer to the control module and is displayed on the teach pendant. When controlling the motion robot to achieve the purpose of automatic targeting, all the calculations involved are completed by the control module. After the user selects the treatment target area on the image display screen, the corresponding data is transmitted to the control module. After calculation and processing, the control module controls the robot to move so that the treatment ultrasonic focal region covers the treatment target area.

[0057] The above-described embodiments are only preferred embodiments cited to fully illustrate the present invention, and the protection scope of the present invention is not limited thereto. Equivalent substitutions or transformations made by those skilled in the art on the basis of the present invention are all within the protection scope of the present invention. The protection scope of the present invention shall be subject to the claims.

Claims

1. A three-dimensional matrix ultrasonic transducer treatment system for integrated diagnosis and treatment, characterized in that It includes a three-dimensional array ultrasonic transducer, a control module and a motion module; The three-dimensional array ultrasonic transducer can not only transmit ultrasonic signals, but also receive echo signals, and can perform ultrasonic treatment and real-time imaging monitoring on the target area; The control module can control the working mode, working parameters of the transducer, and the motion parameters of the motion module; The motion module can pull the three-dimensional array ultrasonic transducer to move freely and perform precise targeted stimulation treatment on the target area.

2. The integrated diagnosis and treatment three-dimensional matrix ultrasonic transducer treatment system according to claim 1, characterized in that, The three-dimensional array ultrasonic transducer is a phased array ultrasonic transducer, comprising an ultrasonic transducer array element and a signal transmission unit; The number of the ultrasonic transducer array elements is 64 to 512, which are arranged in a planar array. The sizes of the array elements are the same, and the working frequency of the array elements has a bandwidth. The center frequency f0 of the array elements is in the range of 0.5-7.5MHz, and the bandwidth range when working at the center frequency f0 is ±25%, so that the array elements can perform imaging at a higher frequency within the bandwidth to obtain better image effects, and perform ultrasonic treatment at the best treatment frequency within the bandwidth to produce the best treatment effect; The signal transmission unit is responsible for information exchange between the control module and the phased array ultrasonic transducer, and each array element has a mutually independent signal transmission unit.

3. The three-dimensional matrix ultrasonic transducer treatment system for integrated diagnosis and treatment according to claim 1, wherein The control module includes a mode control unit, a parameter control unit, a signal processing unit, and a motion control unit; The mode control unit is used to control the working mode of the ultrasonic transducer so that the transducer switches between the treatment mode and the imaging mode; The parameter control unit can control the operating frequency, phase delay, and output power of the transducer. By independently controlling each array element, it can not only dynamically and accurately adjust the phase delay time of each array element to achieve a dynamic focusing function, and adjust the spatial position of the focus and the size of the focal area in real time, but also divide the transducer array into two areas of equal area during treatment, where the ultrasound center frequency emitted by one area is f0-1 / 2Δf, and the ultrasound center frequency emitted by the other area is f0+1 / 2Δf, thereby performing dual-frequency focused ultrasound stimulation on the target area; The signal processing unit can process the incoming electrical signal through phase adjustment, amplification gain, dynamic filtering, signal processing, and image processing steps to form ultrasonic image data; The motion control unit can control the control module to control the motion module to move the ultrasonic transducer to the target position and adjust the posture of the transducer.

4. The three-dimensional matrix ultrasonic transducer treatment system for integrated diagnosis and treatment according to claim 1, characterized in that: The system working modes include ultrasound monitoring mode and ultrasound treatment mode; The ultrasonic monitoring mode works in the imaging mode under the control of the control module, and the ultrasonic transducer array elements arranged in a planar array can provide real-time three-dimensional images of the target area; The ultrasonic treatment mode works in the treatment mode under the control of the control module, and can perform ultrasonic stimulation treatment on the target area.

5. The integrated diagnosis and treatment three-dimensional matrix ultrasound transducer treatment system according to claim 4, characterized in that: The ultrasonic monitoring mode includes a control module, a signal transmission unit, a transmitting unit, and a signal receiving unit; The control module is responsible for sending control signals to adjust the parameters of the imaging ultrasound, and is also responsible for processing the received echo signals and forming image data; The signal transmission unit is responsible for transmitting independent control information to each element and feeding back the information received by each element to the control module; The transmitting unit emits corresponding imaging ultrasonic signals into space according to the control information; The signal receiving unit collects and preprocesses the ultrasonic echo signals containing three-dimensional spatial information and transmits them to the signal transmission unit.

6. The three-dimensional matrix ultrasonic transducer treatment system for integrated diagnosis and treatment according to claim 4, wherein: The ultrasonic treatment mode includes a control module, a signal transmission unit, an excitation unit, and a transmitting unit; The control module is responsible for sending control signals to regulate the parameters of the therapeutic ultrasound; The signal transmission unit is responsible for transmitting independent control information to each excitation unit; The excitation unit amplifies the control signal through excitation to form a corresponding drive signal and transmits it to the transmitting unit; The transmitting unit emits ultrasonic waves to the target area for treatment according to the drive signal.

7. The ultrasonic treatment module according to claim 6, characterized in that: The ultrasonic treatment methods include ultrasonic regulation and ultrasonic hyperthermia treatment; For ultrasonic regulation, the acoustic radiation force generated by ultrasound is used to stimulate the target area, and there will be no obvious temperature rise in the target area during the treatment process; For ultrasonic hyperthermia treatment, the ultrasonic thermal effect is utilized to heat the target area, and the temperature of the target area can be adjusted arbitrarily within the range of 37°C to 65°C.

8. A method for using the three-dimensional matrix array ultrasonic transducer treatment system for integrated diagnosis and treatment according to any one of claims 1-7 above, characterized in that: It includes the following steps: Step 1: Determine the patient information and confirm the treatment parameters; Step 2: Use the monitoring mode for imaging, confirm the treatment target area, and control the transducer to move to the treatment position; Step 3: Treat the patient. Under the action of the control timing signal, start the alternating mode of treatment and imaging monitoring, and obtain real-time B-mode ultrasound image data of the target area while irradiating the target area with ultrasound; Step 4: After the treatment is completed, transmit the corresponding data to the control module, and store the relevant diagnosis and treatment data after obtaining the informed consent of the patient.

9. The usage method according to claim 8, characterized in that: The control timing signal in Step 3 is generated in the following manner: The low-level state of the pulse period of the control pulse signal is set as the imaging monitoring mode, that is, the ultrasonic wave signal emitted by the ultrasonic transducer in this state is used to obtain B-mode imaging images; The high-level state is set as the treatment mode, that is, the ultrasonic wave signal emitted by the ultrasonic transducer in this state is used for ultrasonic treatment; Relative to the treatment mode, the high level represents the normal output of therapeutic ultrasound, and the low level indicates that there is no output of therapeutic ultrasound. At the same time, when the treatment mode is in the low-level period, the imaging monitoring mode is turned on, and the ultrasonic waves emitted by the ultrasonic transducer are used for diagnosis to perform B-mode imaging on the target.

10. The usage method according to claim 9, characterized in that: The treatment mode can select dual-frequency treatment, that is, the array is evenly divided into two areas by area, and two different working frequencies are set for ultrasonic treatment.

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