Low intensity focused ultrasound probe for treating atrial fibrillation and device for treating atrial fibrillation

Abstract

The application is suitable for the medical technical field, and provides a low-intensity focused ultrasound probe for treating atrial fibrillation, which comprises a sound head shell provided with a first containing cavity, a second containing cavity located in the first containing cavity, and four cantilevers arranged along the circumference of the second containing cavity and connected with the first containing cavity; a treatment transducer with a square through hole in the center, the square through hole being sleeved outside the second containing cavity, and the treatment transducer being accommodated in the first containing cavity and used for emitting a low-intensity focused ultrasound beam to regulate and treat a target nerve; and an imaging transducer partially embedded in the second containing cavity, the imaging transducer keeping a relative position fixed with the treatment transducer, and the emitting surface of the imaging transducer being arranged in the same plane with the emitting surface of the treatment transducer, the imaging transducer being used for collecting an ultrasonic image to realize real-time imaging and positioning of the target nerve, so that the treatment and imaging functions are integrated, and the safety and effectiveness of the treatment are significantly improved.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and in particular to a low-intensity ultrasound probe, method, and system for treating atrial fibrillation. Background Technology

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, characterized by high hospitalization, disability, and mortality rates. Epidemiological studies indicate that by 2050, the number of AF patients in Asia is projected to exceed 72 million, placing a heavy burden on the clinical healthcare system. Currently, clinical treatment for AF mainly relies on antiarrhythmic drug therapy and interventional treatments such as catheter-directed radiofrequency ablation. However, these methods generally suffer from long treatment cycles, low rates of sinus rhythm maintenance, and high postoperative recurrence rates, making it difficult to meet the growing clinical needs.

[0003] Recent clinical studies have shown that cardiac autonomic imbalance (especially increased vagal tone and overactivation of the left stellate ganglion) plays a key role in the triggering and maintenance of atrial fibrillation. Based on this mechanism, intervening in atrial fibrillation by modulating the peripheral autonomic nervous system has become a new treatment strategy. However, existing peripheral nerve modulation methods, such as photostimulation, electrical stimulation, drug blockade, or surgical resection, generally have limitations such as invasive operation, lack of visualization, insufficient localization accuracy, and significant side effects. These methods are difficult to achieve safe, precise, and long-term neuromodulation, thus restricting their widespread clinical application.

[0004] Currently, most imaging guidance systems for ultrasound neuromodulation employ either magnetic resonance (MRI) guidance or optical navigation. MRI guidance requires significant equipment investment and operating costs, and most ultrasound transducers produce strong artifacts in an MRI environment, severely impacting image quality and target identification. While optical navigation is relatively cheaper, it cannot image internal human tissues, making true spatial positioning and visualization guidance difficult. Because peripheral nerves have a wide distribution depth—superficial sensory nerve endings are less than 2mm deep, cutaneous nerves range from 2mm to 10mm, nerve trunks are concentrated at 1cm to 4cm, and large nerve roots and trunks can reach depths exceeding 4cm—imaging equipment with excellent spatial resolution is essential for precise targeted modulation of peripheral nerves at different depths and diameters. Among various imaging methods, high-frequency ultrasound has a high cost-performance ratio and excellent spatial resolution. The axial resolution of a 10 MHz ultrasound probe in water can reach 0.1 mm or even higher. Moreover, the acoustic impedance of water is very close to that of human soft tissue. Therefore, high-frequency ultrasound can also achieve high-resolution imaging in the human body, which can meet the imaging needs of nerves of different thicknesses in the human body. Furthermore, the treatment probe can be controlled by software linkage to focus its beam on the target nerve.

[0005] However, most existing ultrasound neuromodulation systems do not integrate high-frequency imaging and treatment functions. Imaging and treatment are usually performed by separate devices, which increases operational complexity and positioning errors. Furthermore, traditional ultrasound transducers struggle to achieve precise focusing on deep nerves in complex tissue environments and lack a dynamic focus tracking mechanism guided by real-time imaging, failing to meet the clinical requirements for real-time and accurate positioning. Most existing devices operate in an open-loop mode, unable to adjust treatment parameters in real time based on changes in electrophysiological signals (such as heart rate and heart rate variability) or ultrasound cavitation effects, resulting in unstable modulation effects and the risk of tissue damage. In addition, existing devices have slow response speeds after detecting abnormal signals (such as excessive cavitation or abnormal heart rate), failing to quickly shut down or adjust the output, resulting in insufficient safety. Summary of the Invention

[0006] The purpose of this invention is to provide a low-intensity ultrasound probe and atrial fibrillation treatment device for treating atrial fibrillation, aiming to solve the technical problems of low positioning accuracy and lack of closed-loop feedback in ultrasound control equipment, resulting in slow response speed and insufficient safety.

[0007] In a first aspect, the present invention provides a low-intensity focused ultrasound probe for treating atrial fibrillation, the low-intensity focused ultrasound probe comprising: The sound head shell has a first receiving cavity, a second receiving cavity located inside the first receiving cavity, and four cantilever arms arranged circumferentially along the second receiving cavity and connected to the first receiving cavity. The treatment transducer has a square through hole in the center, which is sleeved on the outside of the second receiving cavity, and the treatment transducer is housed in the first receiving cavity. It is used to emit a low-intensity focused ultrasound beam to modulate and treat the target nerve. An imaging transducer is partially embedded in the second receiving cavity and is fixed in a relative position with the treatment transducer. The emitting surface of the imaging transducer is arranged coplanarly with the emitting surface of the treatment transducer. The imaging transducer is used to acquire ultrasound images for real-time imaging guidance and positioning of the target nerve. The handle housing is connected to the end of the sound head housing away from the therapeutic transducer and is used by the user to hold it. A cable fixing head is located at the end of the handle housing away from the head housing, and is used to fix the cable.

[0008] In some embodiments, the therapeutic transducer includes: Multiple therapeutic piezoelectric elements arranged in an array are used to emit low-intensity focused therapeutic ultrasound beams; A matching layer is wrapped around the emitting surface and the outer periphery of the therapeutic piezoelectric array element. A conductive connecting block, disposed on the same layer as the therapeutic piezoelectric array element, is used to lead the ground electrode on the lower surface of the therapeutic piezoelectric array element to the excitation surface of the therapeutic transducer.

[0009] In some embodiments, the therapeutic piezoelectric array element is made of type 1-3 piezoelectric composite material and operates at a frequency of 1 MHz.

[0010] In some embodiments, the imaging transducer includes: The sound head integrates an imaging piezoelectric array element, which is used to emit an imaging ultrasonic beam and receive ultrasonic echo signals. An acoustic lens covers the outer surface of the acoustic head; A PCB board is embedded in the sound head, and circuits are arranged on the PCB board to enable the imaging piezoelectric array element to conduct to the external circuit. Connectors are located on both sides of the PCB board and are used to connect to external circuits.

[0011] In some embodiments, the surface of the acoustic lens is provided with a cylindrical protrusion extending along its length, the cylindrical protrusion being used to focus the imaging ultrasonic beam in the elevation direction of the acoustic lens.

[0012] Secondly, the present invention provides an atrial fibrillation treatment device based on the low-intensity focused ultrasound probe described above, the atrial fibrillation treatment device comprising: The coordinate calibration unit is used to establish the imaging coordinate system corresponding to the imaging transducer and the focus control coordinate system corresponding to the treatment transducer, and to obtain the coordinate transformation relationship between the imaging coordinate system and the focus control coordinate system. The treatment control unit is used to acquire ultrasound images of the patient's target nerve region in real time through the imaging transducer, obtain the location information of the target nerve, and use the treatment transducer to treat the target nerve until the treatment ends. The treatment control unit includes: The imaging positioning unit is used to acquire ultrasound images of the target nerve region of the patient in real time through the imaging transducer, identify the target nerve from the ultrasound image, calculate the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system, and map the three-dimensional centroid coordinates to the focus control coordinate system based on the coordinate transformation relationship to obtain the focus coordinates. The drive control unit is used to set the excitation delay and amplitude of each element in the treatment transducer according to the distance difference from the center of each element to the focal coordinate, and control the treatment transducer to emit a synthetic ultrasound beam focused on the focal coordinate according to the excitation delay and amplitude to treat the target nerve. A closed-loop feedback unit is used to acquire electrocardiogram (ECG) signals, dynamically adjust the treatment parameters of the treatment transducer based on the ECG signals, simultaneously acquire the ultrasound echo signals of the target nerve, and control the output parameters of the treatment transducer based on the ultrasound echo signals. The treatment parameters include output sound intensity, pulse repetition frequency, and duty cycle.

[0013] In some embodiments, the treatment control unit further includes a dynamic tracking unit, which is used to continuously image the target nerve in real time by means of the imaging transducer at a rate of at least 10 to 30 frames per second, and when the displacement exceeds a set threshold, automatically update the focal coordinates and reset the excitation delay and amplitude according to the updated focal coordinates.

[0014] In some embodiments, the imaging positioning unit includes: The three-dimensional reconstruction unit is used to acquire multiple frames of two-dimensional ultrasound images of the target area of ​​the patient's heart through the imaging transducer, reconstruct three-dimensional volume data of the target nerve based on the multiple frames of two-dimensional ultrasound images, and establish an image index coordinate system corresponding to the three-dimensional volume data. An image segmentation unit is used to extract the set of voxels belonging to the target neuron from the three-dimensional volume data; The coordinate acquisition unit is used to calculate the average value of all voxel coordinates in the voxel set to obtain the voxel index coordinates of the target nerve in the image index coordinate system. The coordinate transformation unit is used to transform the voxel index coordinates from the image index coordinate system to the imaging coordinate system according to the preset voxel physical spacing, so as to obtain the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system. The focus mapping unit is used to map the three-dimensional centroid coordinates from the imaging coordinate system to the focus control coordinate system based on the coordinate transformation relationship, so as to obtain the focus coordinates of the target nerve in the focus control coordinate system.

[0015] In some embodiments, the closed-loop feedback unit includes an electrophysiological monitoring unit, the electrophysiological monitoring unit comprising: An electrocardiogram (ECG) signal acquisition unit is used to acquire the ECG signal of the target nerve in real time and extract the baseline heart rate and real-time heart rate from the ECG signal. A decrease calculation unit is used to calculate the percentage decrease in the real-time heart rate relative to the baseline heart rate; The parameter comparison unit is used to compare the percentage decrease with a preset target heart rate decrease range, wherein the target heart rate decrease range includes a first threshold and a second threshold, and the first threshold is less than the second threshold. The parameter control unit is used to adjust the treatment parameters of the treatment transducer by a fixed step size if the percentage decrease is lower than the first threshold, and to reduce the output sound intensity of the treatment transducer or stop treatment if the percentage decrease is higher than the second threshold or the patient experiences an adverse reaction.

[0016] In some embodiments, the closed-loop feedback unit further includes a cavitation safety monitoring unit, the cavitation safety monitoring unit comprising: An echo signal acquisition unit is used to acquire ultrasound echo signals of the target nerve region during the emission interval of the treatment transducer using the imaging transducer; The feature extraction unit is used to perform a fast Fourier transform on the ultrasound echo signal to extract the cavitation feature parameters corresponding to the target neural region. The cavitation feature parameters include the energy of subharmonics, superharmonics and broadband noise. A cavitation determination unit is used to monitor the cavitation characteristic parameters in real time. When the intensity of the broadband noise exceeds the preset value of the background noise, or the amplitude of the subharmonic exceeds the preset ratio of the fundamental amplitude, the cavitation is determined to be excessive. The safety response unit is used to cut off the output of the treatment transducer and issue an alarm within a preset time when it is determined that the cavitation exceeds the standard. After the cavitation characteristic parameters fall back to the preset safe range, the output sound intensity of the treatment transducer is reduced to restore treatment.

[0017] This invention integrates treatment and imaging functions by housing the treatment transducer in a first cavity and embedding the imaging transducer in a second cavity, with the emission surfaces of the treatment and imaging transducers arranged coplanarly. This avoids registration errors caused by transducer replacement or repeated positioning. The imaging transducer acquires ultrasound images in real time to identify the target nerve location, completing three-dimensional coordinate positioning and dynamic focus tracking of the target nerve, improving the positioning accuracy of the target nerve and effectively reducing the risk of off-target due to tissue displacement. Furthermore, by receiving ultrasound echo signals from the focal region during the emission interval of the treatment transducer and simultaneously introducing electrophysiological self-feedback and cavitation safety monitoring feedback, the treatment parameters can be adaptively adjusted according to heart rate changes. It can also respond quickly when abnormal heart rate or excessive cavitation is detected, significantly improving the safety and effectiveness of treatment. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of a low-intensity focused ultrasound probe for treating atrial fibrillation provided in an embodiment of the present invention; Figure 2 This is an exploded view of the low-intensity focused ultrasound probe for treating atrial fibrillation provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the sound head shell provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the therapeutic transducer provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of the imaging transducer provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of atrial fibrillation treatment device based on a low-intensity focused ultrasound probe provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of the treatment control unit module provided in an embodiment of the present invention; Figure 8 This is a schematic diagram of the imaging positioning unit provided in an embodiment of the present invention; Figure 9 This is a schematic diagram of the closed-loop feedback unit provided in an embodiment of the present invention; Figure 10 This is a flowchart illustrating the electrophysiological monitoring unit provided in an embodiment of the present invention; Figure 11 This is a schematic diagram of the cavitation safety monitoring unit provided in an embodiment of the present invention. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0020] It should be understood that, when used in this specification and the appended claims, the term "comprising" indicates the presence of the described feature, integral, step, operation, element, and / or component, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components, and / or collections thereof. Furthermore, the terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. The terms "first," "second," and similar words do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Words such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. "Above," "below," "left," "right," etc., are used only to indicate relative positional relationships, which may change accordingly when the absolute position of the described object changes.

[0021] To keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of some known functions and known components are omitted in this specification.

[0022] Please refer to the following: Figures 1 to 2 This invention provides a low-intensity focused ultrasound probe 1 for treating atrial fibrillation. The low-intensity focused ultrasound probe 1 includes a head shell 10, a therapeutic transducer 20, an imaging transducer 30, a handle shell 40, and a cable fixing head 50. The head shell 10 has a first receiving cavity 11, a second receiving cavity 12 located inside the first receiving cavity 11, and four cantilever arms 13 arranged circumferentially along the second receiving cavity 12 and connected to the first receiving cavity 11. The therapeutic transducer 20 has a square through-hole 21 at its center, which is fitted onto the outside of the second receiving cavity 12, and the therapeutic transducer 20 is housed within the first receiving cavity 11. A receiving cavity 11 is used to emit a low-intensity focused ultrasound beam to modulate and treat the target nerve; an imaging transducer 30 is partially embedded in a second receiving cavity 12, and is fixed in a relative position to the treatment transducer 20, with the emitting surface of the imaging transducer 30 and the emitting surface of the treatment transducer 20 arranged coplanarly; the imaging transducer 30 is used to acquire ultrasound images for real-time imaging guidance and positioning of the target nerve; a handle housing 40 is connected to the end of the acoustic head housing 10 away from the treatment transducer 20 for gripping; a cable fixing head 50 is located at the end of the handle housing 40 away from the acoustic head housing 10 for fixing the cable.

[0023] The embodiments of the present invention achieve integrated treatment and imaging functions, realize three-dimensional coordinate localization and dynamic focus tracking of the target nerve, thereby significantly improving the safety and effectiveness of treatment.

[0024] Please refer to the following: Figure 3 In some embodiments, the acoustic head shell 10 has a cuboid structure that extends through both ends. The acoustic head shell 10 has an integrally formed first receiving cavity 11 and a second receiving cavity 12 nested within the area of ​​the first receiving cavity 11. The first receiving cavity 11 and the second receiving cavity 12 are fixedly connected by four cantilever arms 13. The four cantilever arms 13 are arranged circumferentially around the second receiving cavity 12, with one end of each cantilever arm 13 connected to the inner wall of the first receiving cavity 11 and the other end connected to the outer wall of the second receiving cavity 12. The inner wall of the first receiving cavity 11 has an inwardly protruding limiting groove 14, and the outer wall of the second receiving cavity 12 extends outwardly to form a limiting rib 15 that matches the limiting groove 14. The bottom plane of the limiting groove 14 and the upper end face of the limiting rib 15 are coplanar and flush, jointly supporting and defining the assembly position of the therapeutic transducer 20.

[0025] In some embodiments, the four cantilever arms 13 are arranged in pairs opposite each other in a symmetrical distribution to ensure the positional stability and uniform force distribution of the second receiving cavity 12 within the first receiving cavity 11. This allows the therapeutic transducer 20 and the imaging transducer 30 to maintain a fixed relative position after assembly, avoiding relative displacement caused by external forces or temperature changes. This ensures that the spatial transformation relationship between the imaging coordinate system and the therapeutic transducer focus control coordinate system remains stable throughout use. Simultaneously, the space between adjacent cantilever arms 13 forms an open lead-wire channel, facilitating the outward extension of the leads corresponding to each piezoelectric element of the therapeutic transducer 20 via the lead-wire channel between the cantilever arms. This reduces the risk of internal wiring interference within the probe, improving assembly efficiency and the reliability of electrical connections.

[0026] Please refer to the following: Figure 4 In some embodiments, the treatment transducer 20 has a rectangular plate structure and is housed in the first receiving cavity 11. The square through hole 21 of the treatment transducer 20 is sleeved on the outside of the second receiving cavity 12. The inner peripheral edge of the bottom surface of the treatment transducer 20 abuts against the upper end surface of the limiting rib 15, while the outer peripheral edge of the bottom surface of the treatment transducer 20 abuts against the bottom wall of the limiting groove 14, so that the treatment transducer 20 can maintain a horizontal position after assembly.

[0027] In some embodiments, the treatment transducer 20 has a length of 45.6 mm and a width of 34.4 mm. By optimizing and limiting the external dimensions of the treatment transducer 20, it can adapt to the curved shape of the human body surface, ensuring that most of the piezoelectric elements effectively adhere to the skin, achieving efficient ultrasonic energy incidence, while ensuring the accuracy of the focused beam and the output energy. If the surface area of ​​the treatment transducer 20 is too large, since the human skin surface is curved rather than flat, it will lead to poor contact between the probe and the skin, and some elements around the perimeter may be in a non-contact state with the skin, causing these elements to fail, and the emitted sound waves cannot be effectively coupled into the human body. If the surface area is too small, it will greatly reduce the effective arrangement area of ​​the piezoelectric elements, resulting in insufficient ultrasonic focused beam energy, a thicker beam diameter, and a larger focused target area, which will significantly reduce the positioning accuracy and treatment effect of neural targeted modulation.

[0028] In some embodiments, a square through-hole 21 extends through the center of the treatment transducer 20. The square through-hole 21 extends along the thickness direction of the treatment transducer 20. The length of the square through-hole 21 is 33.8 mm and the width is 11.5 mm. The size of the through-hole is adapted to the structural size of the imaging transducer, which can ensure that the imaging transducer 30 can be accommodated in the second receiving cavity 12, while not excessively reducing the effective array area of ​​the treatment transducer 20 due to an excessively large opening.

[0029] In some embodiments, the therapeutic transducer 20 further includes a plurality of therapeutic piezoelectric elements 22 arranged in an array, a matching layer 23, and a conductive connecting block 24. The therapeutic piezoelectric elements 22 are used to emit low-intensity focused therapeutic ultrasound beams. The matching layer 23 wraps around the emitting surface and the surrounding outer sides of the therapeutic piezoelectric elements 22. The conductive connecting block 24 is disposed in the same layer as the therapeutic piezoelectric elements 22 and is used to lead the ground electrode on the lower surface of the therapeutic piezoelectric elements 22 to the excitation surface of the therapeutic transducer 20 (the excitation surface is the signal electrode side of the element, the ground electrode side is covered with the matching layer, the excitation surface is the signal line lead-out surface, and the emitting surface is the ground electrode side).

[0030] In some embodiments, the therapeutic piezoelectric array element 22 is made of type 1-3 piezoelectric composite material, operates at a frequency of 1 MHz, and has a side length of 5.6 mm for each element. The therapeutic piezoelectric array elements 22 are arranged in a rectangular array within the therapeutic transducer 20. Each element is independently driven to emit a low-intensity focused therapeutic ultrasound beam. Compared to ordinary piezoelectric ceramics, type 1-3 piezoelectric composite material has a wider operating bandwidth and higher electroacoustic conversion efficiency, which is beneficial for improving the output efficiency and focusing performance of the therapeutic ultrasound. A gap is provided between adjacent therapeutic piezoelectric array elements 22, and each gap is filled with insulating filler materials such as epoxy resin to achieve electrical isolation and structural support between the elements. Each therapeutic piezoelectric element 22 has an emitting surface and a lower surface arranged opposite to each other. The emitting surface faces the target nerve and its surface is plated with a ground electrode. The ground electrodes of each therapeutic piezoelectric element 22 are interconnected through an electrode plating process to form a common ground electrode. The lower surface of each therapeutic piezoelectric element 22 is plated with a signal (positive) electrode for electrical connection with the positive electrode of an external driving circuit.

[0031] Please refer to the following: Figure 5 In some embodiments, a matching layer 23 is wrapped around the emitting surface and surrounding outer sides of the therapeutic piezoelectric array element 22. The matching layer 23 is made of epoxy resin or doped epoxy resin, and is integrally encapsulated on the surface and surrounding sides of the therapeutic piezoelectric array element 22 using a dedicated potting mold. After the adhesive cures, it is finely ground to the specified thickness. The matching layer 23 is used to achieve acoustic impedance matching between the therapeutic piezoelectric array element 22 and human soft tissue, reduce ultrasound interface reflection loss, improve ultrasound energy transmission efficiency, and at the same time, it plays a role in insulation, sealing, moisture protection, and structural reinforcement of the array element, thereby improving the overall stability and service life of the therapeutic transducer.

[0032] In some embodiments, the conductive connection block 24 is arranged in the same layer as the therapeutic piezoelectric array element 22, and the conductive connection block 24 is located in the diagonal area of ​​the therapeutic transducer array. The conductive connection block 24 is made of conductive material. In the electrode plating process, the ground electrode of each therapeutic piezoelectric array element 22 will be connected to the side or bottom surface of the conductive connection block 24. Therefore, the common ground electrode can be led out to the signal electrode surface of the therapeutic transducer 20 through the conductive connection block 24, thereby realizing that the ground electrode and the positive electrode are led out on the same side.

[0033] In other embodiments, the conductive connection block 24 can also be made of piezoelectric material itself. When plating electrodes, the side of the conductive connection block 24 is also plated with electrodes simultaneously, so that the common ground electrode can be led out from the side of the conductive connection block 24 to the signal electrode surface. This structural design not only simplifies the internal wiring, but also effectively reduces electromagnetic interference and facilitates subsequent circuit connection and packaging operations.

[0034] In some embodiments, the imaging transducer 30 includes an acoustic head 31, an acoustic lens 32, a PCB board 33, and a connector 34. The acoustic head 31 integrates an imaging piezoelectric array (not shown), which is used to emit an imaging ultrasonic beam and receive ultrasonic echo signals. The acoustic lens 32 covers the outer surface of the acoustic head 31. The PCB board 33 is embedded in the acoustic head 31, and circuits are arranged on the PCB board 33 to enable the imaging piezoelectric array to conduct with external circuits. The connector 34 is disposed on both sides of the PCB board 33 for connecting with external circuits.

[0035] In some embodiments, an imaging piezoelectric array element is integrated inside the acoustic head 31. The imaging piezoelectric array element is used to emit imaging ultrasonic beams and receive ultrasonic echo signals. The outer contour of the acoustic head 31 is adapted to the inner wall contour of the second receiving cavity 12, so that the acoustic head 31 can be embedded in the second receiving cavity 12. The assembly gap between the acoustic head 31, the treatment transducer 20 and the acoustic head shell 10 is filled and cured with glue, which further improves the bonding firmness and structural stability of the overall structure, and ensures that the imaging transducer 30 and the treatment transducer 20 maintain a coplanar and precisely aligned assembly state for a long time.

[0036] In some embodiments, the surface of the acoustic lens 32 is provided with a cylindrical protrusion 321 extending along its length. The cylindrical protrusion 321 is used to focus the imaging ultrasonic beam in the elevation direction of the acoustic lens 32. Specifically, the acoustic lens 32 is made of silicone or other polymer materials with a sound velocity less than that of water, possessing good acoustic transmission performance and acoustic impedance matching characteristics. This effectively reduces ultrasonic incident loss and improves the transmission efficiency of imaging ultrasound. Since the sound velocity of the acoustic lens 32 is less than that of human soft tissue, the cylindrical protrusion 321 has a positive lens effect on the passing imaging ultrasonic beam, which can focus the imaging ultrasonic beam in the elevation direction. This reduces the beam slice thickness of the imaging transducer in the elevation direction, improves the spatial resolution of imaging in the elevation direction, and makes the boundary of the target nerve clearer.

[0037] In other embodiments, the acoustic lens 32 can also be made of a material with a sound velocity greater than that of water. In this case, the cylindrical protrusion 321 is replaced with a cylindrical depression, which can also achieve the function of focusing the imaging ultrasonic beam.

[0038] In some embodiments, the PCB board 33 is partially embedded in the bottom of the sound head 31. The PCB board 33 is equipped with a dedicated conductive circuit, which enables the imaging piezoelectric array element to be electrically connected to the circuit on the PCB board. This effectively reduces the overall volume of the imaging transducer, avoids assembly misalignment and vibration interference problems caused by the split structure, and ensures stable operation of the imaging circuit.

[0039] In some embodiments, connectors 34 are symmetrically arranged on both sides of PCB board 33. After each imaging piezoelectric array element is turned on by the internal circuit of PCB board 33, it is electrically connected to the external main control circuit through the connectors 34 on both sides. The dual-side connector layout can balance the circuit load, optimize the wiring layout, and improve the stability and consistency of transmission.

[0040] In some embodiments, the handle housing 40 includes a hollow cylindrical grip portion 42 and a connecting portion 41 integrally formed at one end of the grip portion 42. The grip portion 42 adopts a streamlined structure adapted to the curvature of the human hand to improve grip comfort and operational stability. The connecting portion 41 is integrally formed at the end of the grip portion 42 near the acoustic head housing, and a connecting groove 411 is formed on the end face of the connecting portion 41 away from the grip portion 42. The connecting groove 411 is adapted to the tail structure of the acoustic head housing 10 for nesting and engaging with the acoustic head housing 10, thereby achieving precise positioning, assembly, and fixed connection between the handle housing 40 and the acoustic head housing, preventing circumferential rotation and axial displacement of the acoustic head housing relative to the handle housing 40, and ensuring long-term spatial stability of the imaging transducer and the treatment transducer.

[0041] In some embodiments, the cable retainer 50 is mounted on the end of the handle housing away from the head housing 10. The cable retainer 50 and the handle housing 40 are connected by threads. It is used to centrally store, limit and fix the signal cable and power supply cable inside the probe, and to regulate and constrain the cable passing through the handle housing. The cable retainer 50 is provided with a sealing structure to prevent coupling agent or liquid from seeping into the handle housing 40, while ensuring that the cable remains stably connected during operation.

[0042] Please refer to the following: Figure 6 , Figure 6 This is a schematic diagram of a module for an atrial fibrillation treatment device based on a low-intensity focused ultrasound probe as described above, provided by an embodiment of the present invention. The atrial fibrillation treatment device 600 includes a coordinate calibration unit 601 and a treatment control unit 602. The coordinate calibration unit 601 is used to establish an imaging coordinate system corresponding to the imaging transducer and a focus control coordinate system corresponding to the treatment transducer, and to obtain the coordinate transformation relationship between the imaging coordinate system and the focus control coordinate system. The treatment control unit 602 is used to acquire ultrasound images of the patient's target nerve region in real time through the imaging transducer, obtain the location information of the target nerve, and use the treatment transducer to treat the target nerve until the treatment termination conditions are met.

[0043] In this embodiment of the invention, the coordinate calibration unit 601 first establishes a global spatial coordinate system. Specifically, the global spatial coordinate system of the probe is established with the physical center of the acoustic shell in the probe or a certain fixed reference point as the origin. Under this coordinate system, the imaging coordinate system of the imaging transducer 30 and the focus control coordinate system of the therapeutic transducer 20 are calibrated respectively. The imaging coordinate system preferably has the center of the imaging piezoelectric array element or the center of the array surface as the origin and the array normal direction as the Z-axis. The focus control coordinate system preferably has the center of the array formed by the therapeutic piezoelectric array element 22 as the origin and the array normal direction as the Z-axis. Since the imaging transducer 30 and the treatment transducer 20 maintain a fixed relative position within the acoustic head shell, the spatial transformation relationship between the imaging coordinate system and the focus control coordinate system is a fixed constant matrix. By using precision measuring instruments or standard ultrasound phantoms for acoustic calibration, the relative positional relationship between the imaging surface center and pixel size of the imaging transducer 30 and the center of each element of the treatment transducer 20 is obtained. Based on this, the translation vector and rotation matrix from the imaging coordinate system to the focus control coordinate system are calculated, i.e., the coordinate transformation relationship from the imaging coordinate system to the focus control coordinate system. This lays the foundation for subsequent image-guided focus coordinate mapping.

[0044] In this embodiment of the invention, before the treatment control unit 602 modulates and treats the target nerve through the probe, it is necessary to conduct preoperative screening and status assessment of the patient, use dedicated cardiac ultrasound equipment and electrocardiogram equipment to systematically detect the patient's cardiac working status, comprehensively assess the patient's cardiac structure and basic heart rhythm, strictly screen for treatment contraindications, and select patients suitable for non-invasive ultrasound neuromodulation therapy, so as to ensure the safety and clinical applicability of the treatment from the source.

[0045] In this embodiment of the invention, after preoperative assessment, a low-intensity focused ultrasound probe is positioned on the corresponding area of ​​the patient's body surface, including but not limited to the anterior cervical region, parasternal region, and other peripheral nerve distribution areas. This embodiment uses a robotic arm to position and fix the probe, attaching it to the end of the robotic arm. The probe is then precisely moved and positioned to the target treatment location on the body surface via manual adjustment or automatic positioning by the robotic arm. Furthermore, for dual-function probes with flexible array structures, a coupling gel patch can be pre-attached to the transducer's emitting surface. The probe is then smoothly and securely fixed to the patient's target nerve region using the gel patch, ensuring tight coupling between the transducer's emitting surface and the patient's skin, eliminating air gaps, and ensuring efficient penetration of ultrasound energy into the body tissue.

[0046] In this embodiment of the invention, the treatment control unit 602 continuously determines the treatment termination conditions during the treatment process. When any preset termination condition is met, the treatment transducer is automatically controlled to stop ultrasound emission, ending the current target neuromodulation treatment. The preset termination conditions include the cumulative treatment time reaching a clinically preset standard duration or the patient's atrial fibrillation rhythm successfully converting to sinus rhythm. For example, treatment may be stopped when the cumulative treatment time reaches 15 minutes, 20 minutes, or 30 minutes according to clinical presets, or when atrial fibrillation is successfully converted to sinus rhythm and the sinus rhythm is maintained for more than 5 minutes. This effectively avoids the risk of overtreatment, standardizes the treatment process, and improves the standardization, safety, and repeatability of clinical treatment.

[0047] In this embodiment of the invention, after the treatment transducer stops emitting ultrasound, the imaging transducer preferably continues to maintain the imaging state to monitor the position and morphological changes of the target nerve in real time, assess the immediate effect after treatment, and confirm whether there are abnormalities such as tissue edema, bleeding or nerve displacement, so as to provide imaging basis for subsequent treatment decisions. At the same time, continuous imaging can verify whether there is any residual abnormal cavitation activity in the focal area, further improving the safety of treatment and the completeness of efficacy assessment.

[0048] In this embodiment of the invention, after the treatment control unit 602 determines that the treatment has ended, it automatically generates and records the treatment log, recording key data throughout the treatment process, including the changing trends of heart rate variability time-domain and frequency-domain indices, cavitation monitoring results (including whether cavitation exceedance events occurred, cavitation type and response measures), and the adjustment history of treatment parameters (including the time and reason for changes in sound intensity, pulse repetition frequency, and duty cycle). Based on the comparison of electrocardiograms and echocardiograms before and after treatment, the operator assesses the reduction in atrial fibrillation burden, such as the frequency and duration of atrial fibrillation attacks, and ventricular rate control. Combining this with the treatment log, the operator comprehensively judges the efficacy of the treatment, providing data support for optimizing subsequent treatment plans.

[0049] Please refer to the following: Figure 7 , Figure 7 This is a schematic diagram of the treatment control unit provided by the present invention. The treatment control unit 602 includes an imaging positioning unit 701, a drive control unit 702, and a closed-loop feedback unit 703.

[0050] The imaging positioning unit 701 is used to acquire ultrasound images of the target nerve region of the patient in real time through the imaging transducer, identify the target nerve from the ultrasound image, calculate the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system, and map the three-dimensional centroid coordinates to the focus control coordinate system based on the coordinate transformation relationship to obtain the focus coordinates.

[0051] In this embodiment of the invention, the imaging positioning unit 701 acquires ultrasound images of the target nerve region of the patient in real time through the imaging transducer, completes automatic identification and contour segmentation of the target nerve based on the features of the ultrasound image, and further calculates the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system. The three-dimensional centroid coordinates are used as the target reference point for ultrasound treatment. Through the coordinate transformation relationship pre-established by the coordinate calibration unit 602, the three-dimensional centroid coordinates in the imaging coordinate system are accurately mapped and transformed to the focus control coordinate system of the treatment transducer, and finally obtains the accurate focus coordinates that can be directly used for ultrasound focusing calculation.

[0052] The drive control unit 702 is used to set the excitation delay and amplitude of each element in the treatment transducer according to the distance difference from the center of each element to the focal coordinate, and control the treatment transducer to emit a synthetic ultrasound beam focused on the focal coordinate to treat the target nerve according to the excitation delay and amplitude.

[0053] In this embodiment of the invention, the drive control unit 702 first presets the treatment parameters of the therapeutic transducer, including output sound intensity, pulse repetition frequency, duty cycle, and treatment time. Specifically, the preset range for output sound intensity is 0.5–3.0 W / cm², the preset range for pulse repetition frequency is 100–1000 Hz, the preset range for duty cycle is 20%–60%, and the preset range for treatment time is 15–30 minutes. These treatment parameters can be manually set by the operator according to clinical needs, or automatically matched to a preset scheme based on the type and depth of the target nerve. The therapeutic transducer includes N independently driven therapeutic piezoelectric elements 22 (N≥32). The drive control unit 702 calculates the linear distance difference between the center of each element and the aforementioned focal coordinates based on the spatial coordinates of the center of each therapeutic piezoelectric element, and sets the excitation delay parameters and excitation amplitude parameters corresponding to each therapeutic piezoelectric element based on the linear distance difference between the elements. The drive control unit 702 generates drive signals for each treatment piezoelectric element based on the excitation delay and amplitude of each treatment piezoelectric element and the treatment parameters. It independently drives each element according to the drive signals. Through the coordinated control of the phase and amplitude of multiple elements, the ultrasound beams emitted by each element are coherently superimposed at the focal coordinates to synthesize a high-precision focused ultrasound beam and accurately act on the target nerve. This achieves non-invasive and precise control of the target nerve of the patient's heart, thereby achieving the therapeutic goal of intervening in the occurrence and maintenance of atrial fibrillation.

[0054] The closed-loop feedback unit 703 is used to acquire the electrocardiogram signal of the target nerve, dynamically adjust the treatment parameters of the treatment transducer according to the electrocardiogram signal, synchronously acquire the ultrasound echo signal of the target nerve, and control the output parameters of the treatment transducer according to the ultrasound echo signal. The treatment parameters include output sound intensity, pulse repetition frequency and duty cycle.

[0055] In this embodiment of the invention, the closed-loop feedback unit 703 collects the patient's electrocardiogram signal in real time and analyzes the patient's heart rate change status. Based on the patient's heart rate change status, it adjusts various treatment parameters. At the same time, the closed-loop feedback unit 703 continuously collects the ultrasound echo signal corresponding to the target nerve and controls the ultrasound output parameters of the treatment transducer in real time based on the ultrasound echo signal, so as to realize adaptive adjustment of therapeutic effect and active prevention and control of treatment risk.

[0056] In some embodiments, the treatment control unit further includes a dynamic tracking unit, which is used to continuously image at a rate of at least 10 to 30 frames per second using an imaging transducer, monitor the displacement of the target nerve in real time, automatically update the focal coordinates when the displacement exceeds a set threshold, and reset the excitation delay and amplitude according to the updated focal coordinates.

[0057] In this embodiment of the invention, the dynamic tracking unit works in conjunction with the imaging positioning unit 701 and the drive control unit 702 to control the imaging transducer to continuously acquire two-dimensional ultrasound images at a rate of at least 10 to 30 frames per second, capturing in real time the positional shifts of the target nerve caused by human physiological movements such as breathing and heartbeat, and continuously monitoring the spatial displacement of the target nerve. The focal coordinates are updated every 50 ms, i.e., the coordinate calculation process is re-executed. The target nerve is re-segmented using the latest acquired ultrasound image frames of the patient's cardiac target area, its three-dimensional centroid coordinates in the imaging coordinate system are calculated, and based on the coordinate transformation relationship, these three-dimensional centroid coordinates are mapped to the focal control coordinate system of the treatment transducer to obtain the updated focal coordinates. The updated focal coordinates are compared with the current focal coordinates. When the displacement of the target nerve exceeds a set threshold (preferably 0.5 mm), the excitation delay and excitation amplitude of all treatment piezoelectric array elements of the treatment transducer are recalculated based on the updated focal coordinates. The array elements are driven to emit ultrasound in coordination according to the new parameters, and the focusing position of the synthesized ultrasound beam is dynamically adjusted to achieve synchronous movement of the focal point following the target nerve. This effectively avoids beam off-target problems caused by physiological movement and ensures that the focal positioning error is always controlled within 3 mm throughout the treatment process, effectively reducing the risk of off-target due to tissue displacement.

[0058] Please refer to the following: Figure 8 , Figure 8 This is a schematic diagram of the molding and positioning unit provided by the present invention. The imaging and positioning unit 701 includes a three-dimensional reconstruction unit 801, an image segmentation unit 802, a coordinate acquisition unit 803, a coordinate transformation unit 804, and a focus mapping unit 805.

[0059] The three-dimensional reconstruction unit 801 is used to acquire multiple frames of two-dimensional ultrasound images of the target area of ​​the patient's heart through an imaging transducer, reconstruct three-dimensional volume data of the target nerve based on the multiple frames of two-dimensional ultrasound images, and establish an image index coordinate system corresponding to the three-dimensional volume data.

[0060] In this embodiment of the invention, when performing image reconstruction, the three-dimensional reconstruction unit 801 first controls the imaging transducer to acquire ultrasound images using handheld moving imaging, mechanical swing imaging, or electronic scanning imaging. Specifically: Handheld mobile imaging: The operator holds the handle shell or uses a robotic arm to hold the handle shell, and is equipped with an electromagnetic or optical positioner to move and scan the target area, acquiring multiple frames of two-dimensional ultrasound images with position information, which are then processed by an offline reconstruction algorithm to obtain three-dimensional volume data.

[0061] Mechanical oscillation imaging: If the imaging transducer itself has a mechanical scanning function, the imaging transducer is driven to oscillate at a constant speed in a certain direction. At the same time, multiple frames of two-dimensional images are continuously acquired during the oscillation. Since the oscillation speed and angle are known, the spatial position corresponding to each frame of image can be calculated by motion control parameters. No additional positioner is required. After the acquisition is completed, the continuous multiple frames of two-dimensional images are stacked at known spatial intervals to reconstruct three-dimensional volume data.

[0062] Electronic scanning imaging: If the imaging transducer is a two-dimensional array transducer (i.e., a two-dimensional matrix array, such as 16×16 or 32×32 array elements), then by using electronic beamforming technology, the transmission delay and reception delay of each array element are controlled, so that the imaging ultrasound beam can perform pyramid-shaped or fan-shaped scanning in three-dimensional space, and acquire three-dimensional image data in real time. No mechanical swinging or offline reconstruction is required, which helps to shorten the preoperative preparation time.

[0063] The embodiments of the present invention ultimately obtain a voxel array N comprising voxels along the x, y, and z directions through any of the above methods. x ×N y ×N z The three-dimensional volume data is stored, with each voxel storing a corresponding acoustic echo intensity value. Simultaneously, the three-dimensional reconstruction unit 801 establishes an image index coordinate system corresponding to this three-dimensional volume data. This coordinate system is a virtual discrete coordinate system, with each coordinate axis corresponding to one of the three dimensions of the three-dimensional volume data. It is only used to characterize the row and column arrangement sequence of the voxels within the array and does not possess an actual physical scale.

[0064] The image segmentation unit 802 is used to extract the set of voxels belonging to the target neuron in the three-dimensional volume data and generate a binary segmentation mask.

[0065] In this embodiment of the invention, after the three-dimensional reconstruction unit 801 completes the reconstruction of the three-dimensional volume data, the image segmentation unit 802 performs image segmentation on the three-dimensional volume data to identify the boundaries of the target nerve. Specifically, the image segmentation unit 802 first segments the three-dimensional volume data of size N... x ×N y ×N zThe three-dimensional volume data of voxels is input into a preset voxel set extraction algorithm to extract the voxel set belonging to the target nerve from the volume data. In ultrasound images, different types of nerves have different acoustic characteristics. For example, the left stellate ganglion typically appears as a hypoechoic, spindle-shaped, or lobed structure, located behind the carotid artery and deep to the sternocleidomastoid muscle; the vagus nerve appears as a round or oval hypoechoic structure, located within the carotid sheath. Based on this prior knowledge, the voxel set extraction algorithm can automatically distinguish nerve tissue from surrounding muscle, blood vessels, and adipose tissue. Specifically, the image segmentation unit 802 segments the three-dimensional volume data using binary segmentation to obtain a binary segmentation mask, and then obtains the voxel set corresponding to the target nerve based on the binary segmentation mask. For example, voxels belonging to the target nerve are marked as 1, and background and other tissues are marked as 0. The voxel set S of the target nerve can be represented as: S = {(u,v,w) | voxels (u,v,w) belonging to the target nerve} Where (u, v, w) are the integer coordinates of the voxel in the volume data index space, and u, v, w correspond to the index numbers in the x, y, and z directions, respectively.

[0066] The coordinate acquisition unit 803 is used to calculate the average value of all voxel coordinates in the voxel set to obtain the voxel index coordinates of the target nerve in the image index coordinate system.

[0067] In this embodiment of the invention, after acquiring the voxel set of the target neuron, the image segmentation unit 802 traverses all valid voxel coordinates within the voxel set. The coordinate acquisition unit 803 calculates the voxel index coordinates of the target neuron in the volume data index space by taking the arithmetic mean of all voxel coordinate components. The specific calculation formula is as follows: Where |S| represents the total number of voxels contained in the voxel set S, and the calculated (u c , v c , w c The index coordinates of the target nerve in the volume data index space are the voxel index coordinates, which reflect the relative center of the target nerve in the three-dimensional volume data.

[0068] The coordinate transformation unit 804 is used to transform the voxel index coordinates from the image index coordinate system to the imaging coordinate system according to the preset voxel physical spacing, so as to obtain the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system.

[0069] In this embodiment of the invention, each voxel in the three-dimensional volume data corresponds to a specific physical size in physical space, and each voxel in the volume data corresponds to a fixed physical spatial resolution, determined by the ultrasound imaging scanning range and imaging parameters. When performing coordinate mapping, the coordinate transformation unit 804 first reads the voxel physical spacing and voxel index origin, i.e., the physical spacing Δx, Δy, and Δz of the voxels in the three orthogonal directions x, y, and z. The voxel index origin (u0, v0, w0) corresponds to the physical origin (0, 0, 0) of the imaging coordinate system. Based on the voxel index coordinates and physical spacing parameters obtained in the above steps, the three-dimensional centroid coordinates of the target nerve in the imaging transducer coordinate system are obtained through linear mapping. The specific calculation formula is as follows: Among them, P x P y P z These represent the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system, in millimeters. Through the above coordinate transformation, the coordinate transformation unit 804 converts the pixel position in the ultrasound image into the physical position in the imaging transducer, providing precise input for mapping the position of the target nerve to the focus control coordinate system of the treatment transducer in subsequent steps.

[0070] The focus mapping unit 805 is used to map the three-dimensional centroid coordinates from the imaging coordinate system to the focus control coordinate system based on the coordinate transformation relationship, so as to obtain the focus coordinates of the target nerve in the focus control coordinate system.

[0071] In this embodiment of the invention, the focus mapping unit 805 first retrieves the coordinate transformation relationship obtained by the coordinate calibration unit 601, performs coordinate system space mapping on the three-dimensional centroid coordinates under the imaging coordinate system, maps the three-dimensional centroid coordinates based on the imaging coordinate system to the focus control coordinates, and obtains the focus coordinates of the target nerve under the focus control coordinate system of the treatment transducer. The focus mapping unit 805 outputs the focus coordinates to the drive control unit 702 to ensure that the synthetic ultrasound beam emitted by the treatment transducer can be focused on the focus coordinates.

[0072] Please refer to the following: Figure 9 , Figure 9 The diagram below shows a closed-loop feedback unit 703 provided by the present invention. The closed-loop feedback unit 703 includes an electrophysiological monitoring unit 901 and a cavitation safety monitoring unit 902.

[0073] Please refer to the following: Figure 10 , Figure 10This is a schematic diagram of the electrophysiological monitoring unit provided by the present invention. The electrophysiological monitoring unit 901 includes an electrocardiogram signal acquisition unit 1001, an amplitude calculation unit 1002, a parameter comparison unit 1003, and a parameter adjustment unit 1004.

[0074] The electrocardiogram signal acquisition unit 1001 is used to acquire electrocardiogram signals in real time and extract the baseline heart rate and real-time heart rate from the electrocardiogram signals.

[0075] In this embodiment of the invention, the ECG signal acquisition unit 1001 acquires the patient's original electrocardiogram (ECG) signal in real time through surface electrodes or esophageal electrodes, and performs amplification, noise filtering and analog-to-digital conversion on the ECG signal to eliminate irrelevant noise such as electromyographic interference and power frequency interference. The following feature parameters are extracted from the processed ECG signal: time-domain indices (including SDNN, RMSSD) and frequency-domain indices (including low-frequency power LF, high-frequency power HF and LF / HF ratio) of the baseline heart rate (HR0), real-time heart rate (HR), and heart rate variability (HRV) before treatment. These parameters can reflect the degree of activation of the cardiac autonomic nervous system and the degree of treatment response, providing a quantitative basis for subsequent efficacy judgment and parameter adaptive adjustment.

[0076] The rate of decrease calculation unit 1002 is used to calculate the percentage decrease in real-time heart rate relative to baseline heart rate.

[0077] In this embodiment of the invention, the heart rate reduction calculation unit 1002 calculates the percentage decrease in current real-time heart rate relative to the pre-treatment baseline heart rate ΔHR based on the extracted baseline heart rate and real-time heart rate. The calculation formula can be expressed as: ΔHR=(HR0-HR t ) / HR0×100%; Where HR0 represents the baseline heart rate before treatment, HR t The heart rate is displayed in real time during treatment, and ΔHR represents the percentage decrease in heart rate, reflecting the intensity of the current treatment's regulation of the cardiac autonomic nervous system. If the patient is detected to be in an atrial fibrillation episode, the duration of atrial fibrillation and changes in the electrical activity evoked window are simultaneously recorded, providing a direct reflection of the intervention effect of ultrasound neuromodulation on the atrial fibrillation rhythm.

[0078] The parameter comparison unit 1003 is used to compare the percentage decrease with a preset target heart rate decrease range, the target heart rate decrease range includes a first threshold and a second threshold, and the first threshold is less than the second threshold.

[0079] In this embodiment of the invention, the parameter comparison unit 1003 compares the calculated ΔHR with a preset target heart rate decrease range to determine whether the current ultrasound modulation intensity matches the expected treatment effect, and outputs a corresponding parameter adjustment control command. The preset target heart rate decrease range is defined as a first threshold to a second threshold, wherein the first threshold is the lower limit of the target, the second threshold is the upper limit of the target, and the first threshold is less than the second threshold. For example, the target heart rate decrease range is set to 10%-30%, that is, the first threshold is 10% and the second threshold is 30%.

[0080] The parameter control unit 1004 is used to adjust the treatment parameters of the treatment transducer by a fixed step size if the percentage decrease is lower than the first threshold, and to reduce the output sound intensity of the treatment transducer or stop treatment if the percentage decrease is higher than the second threshold or if the patient has an adverse reaction.

[0081] In this embodiment of the invention, the parameter control unit 1004 performs corresponding parameter adjustment operations according to the comparison results and a preset parameter adjustment cycle. Preferably, the parameter adjustment cycle is ≤15 seconds. Specifically, when performing the corresponding parameter adjustment operation, if the heart rate decrease percentage ΔHR is determined to be lower than a first threshold, indicating insufficient ultrasound stimulation intensity, the treatment parameters of the treatment transducer are adjusted according to a preset fixed step size, i.e., the output sound intensity, pulse repetition frequency, or duty cycle of the treatment transducer are gradually increased to enhance the regulatory effect on the patient's target nerves. If the heart rate decrease percentage ΔHR is determined to be higher than a second threshold, or if the patient is identified from the electrocardiogram signal as having various adverse cardiac reactions such as second-degree atrioventricular block, the output sound intensity of the treatment transducer is immediately reduced, or the treatment transducer is directly controlled to stop treatment to prevent overtreatment from causing safety risks. By controlling the single response cycle of the signal determination and parameter adjustment process to within 15 seconds, the high real-time performance of the therapeutic effect feedback adjustment is ensured.

[0082] Please refer to the following: Figure 11 , Figure 11 This is a schematic diagram of the safety monitoring unit provided by the present invention. The cavitation safety monitoring unit 902 includes an echo signal acquisition unit 1101, a feature extraction unit 1102, a cavitation determination unit 1103, and a safety response unit 1104.

[0083] In this embodiment of the invention, the propagation of an ultrasound beam through human tissue produces physical effects such as thermal and cavitation effects. Cavitation effects include stable cavitation and inertial cavitation: stable cavitation is mainly characterized by the periodic oscillation of microbubbles, while inertial cavitation is characterized by the violent collapse of bubbles. The shock waves and localized high temperatures and pressures generated at the moment of collapse may damage surrounding tissues. Therefore, during ultrasound-modulated treatment of target nerves, it is necessary to monitor the cavitation state of the ultrasound beam propagation path and the focusing target area in real time and implement safe closed-loop feedback control to effectively avoid the safety risks associated with ultrasound treatment and ensure the safety and stability of the treatment process.

[0084] The echo signal acquisition unit 1101 is used to acquire ultrasound echo signals of the target nerve region during the emission interval of the treatment transducer using the imaging transducer.

[0085] In this embodiment of the invention, the imaging transducer and the treatment transducer employ a time-division multiplexing control method throughout the treatment process. Ultrasonic imaging scanning and cavitation signal acquisition are performed during the treatment pulse intervals, while focused ultrasound emission therapy is performed during the treatment working period. This achieves time-division parallel operation of imaging monitoring and ultrasound therapy without interference. Because the treatment transducer and imaging transducer work alternately using time-division multiplexing, the imaging transducer pauses imaging scanning during the intervals of the treatment transducer's emitted ultrasonic beam. At this time, the echo signal acquisition unit 1101 acquires the ultrasonic echo signal reflected from the target area through the imaging transducer, and limits the signal sampling frequency of the imaging transducer to no less than 20MHz, thereby avoiding the loss of high-frequency characteristic signals and providing complete original signal data for accurate identification of the cavitation effect.

[0086] The feature extraction unit 1102 is used to perform fast Fourier transform on the ultrasound echo signal to extract the cavitation feature parameters corresponding to the target neural region. The cavitation feature parameters include the energy of subharmonics, superharmonics and broadband noise.

[0087] In this embodiment of the invention, the feature extraction unit 1102 imports the acquired complete ultrasonic echo time-domain signal into the signal processing unit to perform a fast Fourier transform, completing the conversion from the time-domain signal to the frequency-domain spectrum. From the spectrum, the energy of subharmonics (frequency half the fundamental frequency f0, i.e., f0 / 2), superharmonics (such as 3f0 / 2, 5f0 / 2), and broadband noise components are separated and extracted. By extracting and quantizing the energy of these three components, different cavitation types and intensities can be effectively distinguished. Specifically, the spectral characteristics of stable cavitation are mainly manifested by an increase in subharmonic and superharmonic components, while the spectral characteristics of inertial cavitation are mainly manifested by a significant increase in broadband noise.

[0088] The cavitation determination unit 1103 is used to monitor the cavitation characteristic parameters in real time. When the intensity of the broadband noise exceeds the preset value of the background noise, or the amplitude of the subharmonic exceeds the preset ratio of the fundamental amplitude, the cavitation is determined to be excessive.

[0089] In this embodiment of the invention, the cavitation determination unit 1103 presets a safety threshold and compares the extracted cavitation feature parameters with the preset safety threshold. When the broadband noise intensity corresponding to inertial cavitation is detected to be 20dB higher than the background noise, or the subharmonic amplitude corresponding to stable cavitation reaches 10% or more of the fundamental amplitude, it is determined that the inertial cavitation or steady-state cavitation intensity in the target area of ​​the target point is too high, that is, it is determined that the cavitation exceeds the standard.

[0090] The safety response unit 1104 is used to cut off the output of the treatment transducer and issue an alarm within a preset time when it is determined that the cavitation exceeds the standard. After the cavitation characteristic parameters fall back to the preset safe range, the output sound intensity of the treatment transducer is reduced to restore treatment.

[0091] In this embodiment of the invention, when the cavitation determination unit 1103 determines that cavitation exceeds the standard, the safety response unit 1104 quickly cuts off the ultrasonic power output of the treatment transducer within a preset time period, which is set to within 1 second. At the same time, it issues an audible and visual alarm to alert medical staff that there is a cavitation safety risk. It continuously monitors changes in cavitation characteristic parameters in real time. Once the characteristic parameters such as subharmonics and broadband noise fall back to within the preset safety threshold range, treatment can be automatically restored or restarted after manual confirmation. When restarting treatment, it will actively reduce the output sound intensity of the treatment transducer, for example, by 20%, thereby effectively reducing the risk of tissue damage caused by cavitation effect and ensuring the safety of treatment and the continuity of clinical operation.

[0092] The above embodiments are merely illustrative of the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that the scope of disclosure involved in the above embodiments is not limited to technical solutions formed by specific combinations of the above technical features, but should also cover other technical solutions formed by arbitrary combinations of the above technical features or their equivalent features without departing from the above-disclosed concept. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0093] Furthermore, while the operations are described in a specific order, this should not be construed as requiring these operations to be performed in the specific order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Similarly, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the invention. Certain features described in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments.

Claims

1. A low-intensity focused ultrasound probe for treating atrial fibrillation, characterized in that, The low-intensity focused ultrasound probe includes: The sound head shell has a first receiving cavity, a second receiving cavity located inside the first receiving cavity, and four cantilever arms arranged circumferentially along the second receiving cavity and connected to the first receiving cavity. The treatment transducer has a square through hole in the center, which is sleeved on the outside of the second receiving cavity, and the treatment transducer is housed in the first receiving cavity. It is used to emit a low-intensity focused ultrasound beam to modulate and treat the target nerve. An imaging transducer is partially embedded in the second receiving cavity and is fixed in a relative position with the treatment transducer. The emitting surface of the imaging transducer is arranged coplanarly with the emitting surface of the treatment transducer. The imaging transducer is used to acquire ultrasound images for real-time imaging guidance and positioning of the target nerve. The handle housing is connected to the end of the sound head housing away from the therapeutic transducer and is used by the user to hold it. A cable fixing head is located at the end of the handle housing away from the head housing, and is used to fix the cable.

2. The low-intensity focused ultrasound probe for treating atrial fibrillation as described in claim 1, characterized in that, The therapeutic transducer includes: Multiple therapeutic piezoelectric elements arranged in an array are used to emit low-intensity focused therapeutic ultrasound beams; A matching layer is wrapped around the emitting surface and the outer periphery of the therapeutic piezoelectric array element. A conductive connecting block, disposed on the same layer as the therapeutic piezoelectric array element, is used to lead the ground electrode on the lower surface of the therapeutic piezoelectric array element to the excitation surface of the therapeutic transducer.

3. The low-intensity focused ultrasound probe for treating atrial fibrillation as described in claim 2, characterized in that, The therapeutic piezoelectric array element is made of type 1-3 piezoelectric composite material and operates at a frequency of 1 MHz.

4. The low-intensity focused ultrasound probe for treating atrial fibrillation as described in claim 1, characterized in that, The imaging transducer includes: The sound head integrates an imaging piezoelectric array element, which is used to emit an imaging ultrasonic beam and receive ultrasonic echo signals. An acoustic lens covers the outer surface of the acoustic head; A PCB board is embedded in the sound head, and circuits are arranged on the PCB board to enable the imaging piezoelectric array element to conduct to the external circuit. Connectors are located on both sides of the PCB board and are used to connect to external circuits.

5. The low-intensity focused ultrasound probe for treating atrial fibrillation as described in claim 4, characterized in that, The surface of the acoustic lens is provided with a cylindrical protrusion extending along its length, which is used to focus the imaging ultrasonic beam in the elevation direction of the acoustic lens.

6. An atrial fibrillation treatment device based on the low-intensity focused ultrasound probe according to any one of claims 1 to 5, characterized in that, The atrial fibrillation treatment device includes: The coordinate calibration unit is used to establish the imaging coordinate system corresponding to the imaging transducer and the focus control coordinate system corresponding to the treatment transducer, and to obtain the coordinate transformation relationship between the imaging coordinate system and the focus control coordinate system. The treatment control unit is used to acquire ultrasound images of the patient's target nerve region in real time through the imaging transducer, obtain the location information of the target nerve, and use the treatment transducer to treat the target nerve until the treatment ends. The treatment control unit includes: The imaging positioning unit is used to acquire ultrasound images of the target nerve region of the patient in real time through the imaging transducer, identify the target nerve from the ultrasound image, calculate the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system, and map the three-dimensional centroid coordinates to the focus control coordinate system based on the coordinate transformation relationship to obtain the focus coordinates. The drive control unit is used to set the excitation delay and amplitude of each element in the treatment transducer according to the distance difference from the center of each element to the focal coordinate, and control the treatment transducer to emit a synthetic ultrasound beam focused on the focal coordinate according to the excitation delay and amplitude to treat the target nerve. A closed-loop feedback unit is used to acquire electrocardiogram (ECG) signals, dynamically adjust the treatment parameters of the treatment transducer based on the ECG signals, simultaneously acquire the ultrasound echo signals of the target nerve, and control the output parameters of the treatment transducer based on the ultrasound echo signals. The treatment parameters include output sound intensity, pulse repetition frequency, and duty cycle.

7. The atrial fibrillation treatment device according to claim 6, characterized in that, The treatment control unit further includes a dynamic tracking unit, which is used to continuously image at a rate of at least 10 to 30 frames per second through the imaging transducer to monitor the displacement of the target nerve in real time. When the displacement exceeds a set threshold, the dynamic tracking unit automatically updates the focal coordinates and resets the excitation delay and amplitude according to the updated focal coordinates.

8. The atrial fibrillation treatment device according to claim 6, characterized in that, The imaging positioning unit includes: The three-dimensional reconstruction unit is used to acquire multiple frames of two-dimensional ultrasound images of the target nerve region of the patient through the imaging transducer, reconstruct three-dimensional volume data of the target nerve based on the multiple frames of two-dimensional ultrasound images, and establish an image index coordinate system corresponding to the three-dimensional volume data. An image segmentation unit is used to extract the set of voxels belonging to the target neuron from the three-dimensional volume data; The coordinate acquisition unit is used to calculate the average value of all voxel coordinates in the voxel set to obtain the voxel index coordinates of the target nerve in the image index coordinate system. The coordinate transformation unit is used to transform the voxel index coordinates from the image index coordinate system to the imaging coordinate system according to the preset voxel physical spacing, so as to obtain the three-dimensional centroid coordinates of the target nerve in the imaging coordinate system. The focus mapping unit is used to map the three-dimensional centroid coordinates from the imaging coordinate system to the focus control coordinate system based on the coordinate transformation relationship, so as to obtain the focus coordinates of the target nerve in the focus control coordinate system.

9. The atrial fibrillation treatment device according to claim 6, characterized in that, The closed-loop feedback unit includes an electrophysiological monitoring unit, which includes: An electrocardiogram (ECG) signal acquisition unit is used to acquire ECG signals in real time and extract baseline heart rate and real-time heart rate from the ECG signals. A decrease calculation unit is used to calculate the percentage decrease in the real-time heart rate relative to the baseline heart rate; The parameter comparison unit is used to compare the percentage decrease with a preset target heart rate decrease range, wherein the target heart rate decrease range includes a first threshold and a second threshold, and the first threshold is less than the second threshold. The parameter control unit is used to adjust the treatment parameters of the treatment transducer by a fixed step size if the percentage decrease is lower than the first threshold, and to reduce the output sound intensity of the treatment transducer or stop treatment if the percentage decrease is higher than the second threshold or the patient experiences an adverse reaction.

10. The atrial fibrillation treatment device according to claim 6, characterized in that, The closed-loop feedback unit further includes a cavitation safety monitoring unit, which includes: An echo signal acquisition unit is used to acquire ultrasound echo signals of the target nerve region during the emission interval of the treatment transducer using the imaging transducer; The feature extraction unit is used to perform a fast Fourier transform on the ultrasound echo signal to extract the cavitation feature parameters corresponding to the target neural region. The cavitation feature parameters include the energy of subharmonics, superharmonics and broadband noise. A cavitation determination unit is used to monitor the cavitation characteristic parameters in real time. When the intensity of the broadband noise exceeds the preset value of the background noise, or the amplitude of the subharmonic exceeds the preset ratio of the fundamental amplitude, the cavitation is determined to be excessive. The safety response unit is used to cut off the output of the treatment transducer and issue an alarm within a preset time when it is determined that the cavitation exceeds the standard. After the cavitation characteristic parameters fall back to the preset safe range, the output sound intensity of the treatment transducer is reduced to restore treatment.

Images