Neural mapping assembly, neural mapping catheter, and neural mapping system

Abstract

The application provides a nerve mapping assembly, a nerve mapping catheter and a nerve mapping system, the nerve mapping assembly comprising an elastic structure, an ultrasonic transducer array and a first support tube, the elastic structure and the first support tube are both adapted to be arranged in an arc shape, the elastic structure is arranged in the first support tube; the ultrasonic transducer array comprises a plurality of ultrasonic transducer elements; the elastic structure has a first guide wire cavity penetrating through a proximal end and a distal end thereof, when a guide wire is inserted into the first guide wire cavity, the elastic structure, the first support tube and the ultrasonic transducer array can tend to be in a linear state; the ultrasonic transducer array is used for emitting ultrasonic waves to a target region, also receives echoes and converts them into corresponding electrical signals, so as to generate a corresponding target region ultrasonic image. The application can determine the position of nerve tissue according to the target region ultrasonic image, and can completely avoid uncontrollable factors caused by disordered and targetless electric stimulation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a neural mapping component, a neural mapping catheter, and a neural mapping system. Background Technology

[0002] Overactive nerves can adversely affect human organs and tissues, leading to a range of diseases. Common heart diseases, circulatory system disorders (hypertension), or kidney diseases can all be caused by excessive activity of the local sympathetic nervous system. For example, chronic activation of the renal sympathetic nervous system can cause excessive secretion of one or more renins, resulting in increased sodium reabsorption by the kidneys or increased cardiac output, ultimately leading to elevated blood pressure. Furthermore, long-term overactivity of the sympathetic nervous system can cause irreversible damage to internal organs due to excessively high levels of certain hormones (such as norepinephrine). By inhibiting the activity level of the local sympathetic nervous system, these symptoms can potentially be treated to some extent.

[0003] For example, renal sympathetic denervation (RDN) lowers blood pressure by inhibiting the activity of the renal sympathetic nerves. Radiofrequency ablation is one of the most common nerve ablation methods. RDN radiofrequency ablation involves percutaneous insertion of a radiofrequency ablation catheter through the femoral artery to both renal arteries. Electrodes on the catheter release radiofrequency energy in selected areas, generating high temperatures in the renal artery intima. This selectively blocks the conduction function of sympathetic nerve fibers in the renal artery wall, reducing sympathetic nerve excitability and thus lowering blood pressure. Ablation of afferent nerves reduces nerve impulses ascending to the central nervous system, decreasing sympathetic nerve excitability, thereby lowering heart rate, myocardial contractility, and stroke volume, thus reducing cardiac output and lowering blood pressure. Ablation of efferent nerves reduces the activity of descending nerves, increasing glomerular filtration rate, reducing renal reabsorption capacity, decreasing sodium and water reabsorption, leading to increased sodium and water excretion, reducing blood volume, and lowering blood pressure.

[0004] In existing technologies, some experts have proposed mapping the sympathetic nerves around the renal artery using electrical pulse stimulation, utilizing the blood pressure changes during stimulation to find areas where blood pressure will significantly decrease after ablation, thereby avoiding accidental ablation of non-target tissues. However, this technology currently has the following problems: (i) The system itself does not provide a positioning catheter function, making it almost impossible to repeat the location of each stimulation mapping. The stimulation points are disordered and arbitrary, thus this non-standardized process introduces significant uncontrollable factors into the surgical outcome; (ii) Electrical pulse stimulation itself can place a heavy burden on patients. In several completed small-sample clinical trials, many patients reported unbearable pain during stimulation. Therefore, disordered and untargeted electrical pulse stimulation not only fails to achieve the desired effect but also causes additional harm to patients.

[0005] It should be noted that the information disclosed in the background section of this invention is intended only to enhance the understanding of the general background of this invention, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a neural mapping component, a neural mapping catheter, and a neural mapping system that can capture ultrasound images of a target area using an ultrasound transducer array. Based on the captured ultrasound images of the target area, the location of nerve tissue can be determined, thereby obtaining the location information of the nerve stimulation target. This completely avoids the uncontrollable factors caused by disordered and untargeted electrical stimulation. At the same time, by eliminating meaningless electrical stimulation, the physical burden on patients can be significantly reduced, and the pain and risks they need to endure during surgery can be reduced.

[0007] To achieve the above objectives, the present invention provides a neural mapping component, including an elastic structural member, an ultrasonic transducer array, and a first support tube. Both the elastic structural member and the first support tube are adapted to be arranged in an arc shape, and the elastic structural member is disposed inside the first support tube.

[0008] The ultrasonic transducer array includes multiple ultrasonic transducer elements arranged in an arc-shaped array. The multiple ultrasonic transducer elements are spaced apart along the length direction of the elastic structure and fixed to the elastic structure.

[0009] The elastic structure has a first guidewire lumen extending through its proximal and distal ends. When a guidewire is inserted into the first guidewire lumen, the elastic structure, the first support tube, and the ultrasonic transducer array can tend to be in a straight line.

[0010] The ultrasonic transducer array is used to emit ultrasonic waves that can reach the nerve tissue within the target area, so that the nerve tissue and other tissues within the target area can reflect back corresponding echoes. The ultrasonic transducer array is also used to receive the echoes and convert them into corresponding electrical signals to generate corresponding ultrasonic images of the target area.

[0011] Optionally, the elastic structural member has a mounting plane for fixing the ultrasonic transducer array on the side away from its center of curvature. The mounting plane has a plurality of spaced baffles along its length, and the baffles are located between two adjacent ultrasonic transducer elements.

[0012] Optionally, the elastic structure is a hollow structure, and a connecting post is provided inside the elastic structure along its length direction, with the first guide wire cavity penetrating the proximal and distal ends of the connecting post.

[0013] Optionally, the neural mapping assembly further includes a position sensor for monitoring the position information of the neural mapping assembly. The position sensor is fixed within the elastic structure, and a first wire cavity for the passage of the ultrasonic transducer element wire and a second wire cavity for the passage of the position sensor wire are formed between the position sensor and the inner wall of the elastic structure.

[0014] Optionally, the first support tube has an opening on the side away from its center of curvature, and the neural mapping assembly further includes a catheter sheath covering the outside of the first support tube, with the ultrasound transducer array located within the catheter sheath.

[0015] Optionally, the neural mapping assembly further includes a flexible tube connected to the distal end of the first support tube, the flexible tube having a second guidewire lumen extending through both ends of its axial direction, the second guidewire lumen communicating with the first guidewire lumen.

[0016] Optionally, the outer diameter of the flexible hose gradually decreases from its proximal end to its distal end.

[0017] Optionally, the neural mapping assembly further includes a second support tube, the distal end of which is connected to the proximal end of the first support tube, and the second support tube has a third guidewire lumen extending through both ends of its axial direction, the third guidewire lumen being connected to the first guidewire lumen.

[0018] Optionally, the second support tube includes a coaxially arranged and hollow outer tube and an inner tube, the inner tube being inserted into the outer tube, and at least a portion of the inner tube wall being recessed toward its axis to form a plurality of grooves extending along its axial direction.

[0019] Optionally, the neural mapping assembly further includes at least one electrode disposed outside the first support tube and positioned away from the ultrasonic transducer array.

[0020] To achieve the above objectives, the present invention also provides a neural mapping catheter, including a tube body and the neural mapping component described above, wherein the distal end of the tube body is connected to the proximal end of the neural mapping component.

[0021] Optionally, the tube includes a bendable segment and a main body segment connected sequentially along its distal to proximal direction, the distal end of the bendable segment being connected to the proximal end of the neural mapping component.

[0022] To achieve the above objectives, the present invention also provides a neural mapping system, which includes an energy output device, a controller, and the neural mapping conduit described above. The energy output device and the ultrasound transducer array are both communicatively connected to the controller. The energy output device is configured to provide mapping energy to the ultrasound transducer array so that the ultrasound transducer array can emit ultrasound waves toward the target region. The controller is configured to generate a corresponding ultrasound image of the target region based on the electrical signal, and to obtain the location information of the nerve stimulation target point based on the ultrasound image of the target region.

[0023] Optionally, the controller is configured to acquire the location information of the neural stimulation target through the following steps:

[0024] The ultrasound image of the target region is used to identify the contours of neural tissue in order to determine whether neural tissue exists in the ultrasound image of the target region.

[0025] If neural tissue is present in the ultrasound image of the target area, the location information of the neural mapping component at the time of acquisition of the ultrasound image of the target area is used as the location information of the neural stimulation target.

[0026] Optionally, the step of identifying the neural tissue contour in the ultrasound image of the target region to determine whether neural tissue exists in the ultrasound image of the target region includes:

[0027] For each pixel in the ultrasound image of the target region, calculate the rate of change of brightness between that pixel and its neighboring pixels;

[0028] Based on the brightness change rate of each pixel in the ultrasound image of the target region, all candidate neural tissue contour points are identified.

[0029] Based on all the candidate neural tissue contour points, determine whether neural tissue exists in the ultrasound image of the target region.

[0030] Optionally, the step of finding all candidate neural tissue contour points based on the brightness change rate corresponding to each pixel in the ultrasound image of the target region includes:

[0031] For each pixel in the ultrasound image of the target region, determine whether the absolute value of the brightness change rate corresponding to the pixel is greater than a first preset threshold. If so, the pixel with the smaller gray value among the pixel and its neighboring pixels is selected as a candidate neural tissue contour point.

[0032] Optionally, determining whether neural tissue exists in the ultrasound image of the target region based on all the candidate neural tissue contour points includes:

[0033] If at least some of the candidate neural tissue contour points can be connected in series to form a closed curve, then it is determined that neural tissue exists in the ultrasound image of the target region.

[0034] Optionally, the controller is further configured to perform the following operations before recognizing the neural tissue contours of the ultrasound image of the target region:

[0035] The ultrasound image of the target region is denoised to obtain a denoised ultrasound image of the target region.

[0036] Optionally, the denoising process for the ultrasound image of the target region includes:

[0037] The ultrasound image of the target region is uniformly divided into multiple intervals of the same size;

[0038] For each interval, the average gray value of all pixels in the interval is taken as the gray value of all pixels in the interval to obtain the corresponding neural probability distribution map.

[0039] The neural probability distribution map is smoothed to obtain a denoised ultrasound image of the target region.

[0040] Optionally, the controller is also configured to perform the following steps:

[0041] The operator is reminded to mark the nerve stimulation target on the three-dimensional model of the target area, and / or to control the nerve mapping catheter to perform electrical stimulation on the location of the nerve stimulation target, and to determine whether the location of the nerve stimulation target meets the ablation requirements based on the results of the electrical stimulation.

[0042] Optionally, the energy output device includes an excitation drive module, an excitation acquisition module, and external components, wherein the external components include at least one of a foot switch, a display, and a touch screen.

[0043] Optionally, the neural mapping system further includes a three-dimensional mapping device and a positioning module connected in communication. The three-dimensional mapping device includes a three-dimensional display, and both the three-dimensional mapping device and the positioning module are connected in communication with the controller.

[0044] Optionally, the controller includes a data processing module, a processor, and an ultrasound image generation module, both of which are communicatively connected to the processor.

[0045] Compared with the prior art, the neural mapping component, neural mapping catheter, and neural mapping system provided by the present invention have the following advantages:

[0046] The neural mapping component provided by this invention includes an elastic structure, an ultrasonic transducer array, and a first support tube. Both the elastic structure and the first support tube are adapted to be arc-shaped, with the elastic structure disposed within the first support tube. The ultrasonic transducer array includes multiple ultrasonic transducer elements arranged in an arc-shaped array. These multiple ultrasonic transducer elements are spaced apart along the length of the elastic structure and fixed to it. The elastic structure has a first guidewire lumen extending through its proximal and distal ends. When a guidewire is inserted into the first guidewire lumen, the elastic structure, the first support tube, and the ultrasonic transducer array tend to be in a straight line. The ultrasonic transducer array is used to emit ultrasonic waves capable of reaching the nerve tissue within the target area, so that the nerve tissue and other tissues within the target area can reflect corresponding echoes. The ultrasonic transducer array is also used to receive the echoes and convert them into corresponding electrical signals to generate corresponding ultrasound images of the target area. Therefore, this invention captures ultrasound images of the target area using an ultrasound transducer array, allowing for the determination of the location of nerve tissue based on these images. This enables the acquisition of the location information of the nerve stimulation target, completely avoiding the uncontrollable factors caused by disordered and untargeted electrical stimulation. Simultaneously, by eliminating meaningless electrical stimulation, the physical burden on patients can be significantly reduced, minimizing pain and risks during surgery. Furthermore, since the ultrasound transducer array comprises multiple ultrasound transducer elements arranged in an arc shape, the detection range can be expanded, enabling the detection of nerves within a specific area. This results in a complete and clear ultrasound image of the target area, laying a solid foundation for subsequent nerve tissue identification. Moreover, because the elastic structure and the first support tube can tend towards a straight line under the guidance of the guidewire, the nerve mapping component can be delivered to the target area in a straight line, further facilitating the delivery of the nerve mapping component provided by this invention.

[0047] Since the neural mapping catheter and neural mapping system provided by this invention belong to the same inventive concept as the neural mapping component provided by this invention, the neural mapping catheter and neural mapping system provided by this invention have at least all the advantages of the neural mapping component provided by this invention. For details, please refer to the relevant description of the beneficial effects of the neural mapping component provided by this invention above. Therefore, the beneficial effects of the neural mapping catheter and neural mapping system provided by this invention will not be elaborated here. Attached Figure Description

[0048] Figure 1 This is a schematic diagram of the overall structure of the neural mapping component provided in the first embodiment of the present invention;

[0049] Figure 2 This is a partial structural schematic diagram of the neural mapping component provided in the first embodiment of the present invention;

[0050] Figure 3 This is a cross-sectional view of the neural mapping assembly provided in the first embodiment of the present invention during guidewire insertion;

[0051] Figure 4 This is a cross-sectional view of the neural mapping assembly provided in the first embodiment of the present invention during guidewire withdrawal;

[0052] Figure 5 This is a partial cross-sectional view of the neural mapping component provided in the first embodiment of the present invention;

[0053] Figure 6 for Figure 5 A partially enlarged structural diagram of part A in the diagram;

[0054] Figure 7 This is a schematic diagram of the structure of an ultrasonic transducer element provided in an embodiment of the present invention;

[0055] Figure 8 This is a schematic diagram of an ultrasonic transducer array provided in an embodiment of the present invention;

[0056] Figure 9 This is a schematic diagram of the neural mapping component acquiring ultrasound images according to the first embodiment of the present invention;

[0057] Figure 10 This is a schematic diagram of an elastic structural member in a bent state according to an embodiment of the present invention;

[0058] Figure 11 This is a schematic diagram of an elastic structural member in a straight state according to an embodiment of the present invention.

[0059] Figure 12 This is a schematic diagram of the overall structure of the second support tube provided in an embodiment of the present invention;

[0060] Figure 13 This is a partial structural schematic diagram of the second support tube provided in an embodiment of the present invention;

[0061] Figure 14 This is a schematic diagram of the overall structure of the neural mapping component provided in the second embodiment of the present invention;

[0062] Figure 15 This is a partial structural schematic diagram of the neural mapping component provided in the second embodiment of the present invention;

[0063] Figure 16 for Figure 15 Top view;

[0064] Figure 17 This is a schematic diagram of the overall structure of a nerve mapping catheter provided in an embodiment of the present invention;

[0065] Figure 18 This is a schematic diagram of the overall structure of a neural mapping system provided in an embodiment of the present invention;

[0066] Figure 19 An ultrasound image of a target region containing neural tissue is provided as a specific example of the present invention.

[0067] Figure 20 A schematic diagram illustrating the conversion of a target region ultrasound image into a two-dimensional vector matrix, as provided in a specific example of the present invention;

[0068] Figure 21 A vector diagram of the rate of change of brightness provided as a specific example of the present invention;

[0069] Figure 22 A schematic diagram of the outline of neural tissue directly identified using the brightness change rate algorithm, as a specific example of the present invention;

[0070] Figure 23a for Figure 19 The diagram shows the probability distribution of nerves corresponding to the ultrasound image of the target area.

[0071] Figure 23b for Figure 23a The ultrasound image of the target region obtained after smoothing the neural probability distribution map shown is a denoised image.

[0072] Figure 23c for Figure 23b A schematic diagram of the neural tissue contour recognition results;

[0073] Figure 24 This is a flowchart of a neural mapping system provided in an embodiment of the present invention.

[0074] The reference numerals in the attached figures are as follows:

[0075] Neural mapping assembly - 100; Elastic structural component - 110; First guidewire lumen - 111; Mounting plane - 112; Baffle - 113; Connecting post - 114; First lead wire lumen - 115; Second lead wire lumen - 116; Ultrasonic transducer array - 120; Ultrasonic transducer element - 121; First support tube - 130; Pull wire lumen - 131; Fourth guidewire lumen - 132; Third lead wire lumen - 133; Position sensor - 140; Catheter sheath - 150; Flexible tubing - 160; Second guidewire lumen - 161; Second support tube - 170; Third guidewire lumen - 171; Outer tube - 172; Inner tube - 173; Groove - 1731; Electrode - 180; Fixing component - 190;

[0076] Pipe body-210; bendable section-211; main section-212; handle-220;

[0077] Energy output device - 300; Foot switch - 310; Display - 320; Touch screen - 330; Excitation drive module - 340; Excitation acquisition module - 350; Tail wire - 360;

[0078] Controller-400; Data processing module-410; Processor-420; Ultrasonic image generation module-430;

[0079] 3D mapping equipment-500; 3D display-510;

[0080] Positioning Module-600;

[0081] Guidewire-10;

[0082] Piezoelectric thin film sensor-21; Energy signal source-22; Signal wires-23a, 23b; Contact points-24a, 24b; Nerve tissue-25; Emitting ultrasound-26; Reflecting ultrasound waves-27. Detailed Implementation

[0083] The following detailed description of the neural mapping components, neural mapping catheters, and neural mapping systems proposed in this invention, in conjunction with the accompanying drawings and specific embodiments, will further illustrate these features. The advantages and features of this invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, intended only to facilitate and clarify the illustration of the embodiments of this invention. Please refer to the drawings for a clearer understanding of the objectives, features, and advantages of this invention. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only for illustrative purposes and to enable those skilled in the art to understand and read the invention, and are not intended to limit the implementation conditions of this invention. Any modifications to the structure, changes in proportions, or adjustments to the size, provided they produce the same or similar effects and achieve the same objectives as this invention, should still fall within the scope of the technical content disclosed in this invention. Specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes, will be determined in part by the specific application and usage environment. Furthermore, in the embodiments described below, the same reference numerals are sometimes used across different drawings to denote the same parts or parts with the same function, omitting repeated descriptions. In this specification, similar reference numerals and letters are used to denote similar items; therefore, once an item is defined in one figure, it need not be discussed further in subsequent figures. Furthermore, if the methods described herein involve a series of steps, and the order of these steps presented herein is not necessarily the only possible order in which they can be performed, some of the described steps may be omitted and / or other steps not described herein may be added to the method.

[0084] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor should they be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. The singular forms "a," "an," and "the" include plural objects; the term "or" is generally used to include "and / or"; the term "several" is generally used to include "at least one"; and the term "at least two" is generally used to include "two or more".

[0085] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. In the description of this invention, unless otherwise expressly specified and limited, the terms "installed," "connected," "joined," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Moreover, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0086] The core idea of ​​this invention lies in providing a neural mapping component, a neural mapping catheter, and a neural mapping system. These components can capture ultrasound images of a target area using an ultrasound transducer array, thereby determining the location of nerve tissue based on the captured ultrasound images and obtaining the location information of the nerve stimulation target. This completely avoids the uncontrollable factors caused by disordered and untargeted electrical stimulation. Simultaneously, by eliminating meaningless electrical stimulation, the physical burden on patients can be significantly reduced, minimizing pain and risks during surgery. It should be noted that, as those skilled in the art will understand, "distal" in this document refers to the end furthest from the operator (i.e., the end closer to the target area), and "proximal" refers to the end closer to the operator (i.e., the end furthest from the target area). Furthermore, it should be noted that, as those skilled in the art will understand, the "target area" in this invention includes, but is not limited to, the renal artery.

[0087] To achieve the above ideas, this invention provides a neural mapping component, please refer to... Figures 1 to 6 ,in, Figure 1 This is a schematic diagram of the overall structure of the neural mapping component provided in the first embodiment of the present invention; Figure 2 This is a partial structural schematic diagram of the neural mapping component provided in the first embodiment of the present invention; Figure 3 This is a cross-sectional view of the neural mapping assembly provided in the first embodiment of the present invention during guidewire insertion; Figure 4 This is a cross-sectional view of the neural mapping assembly provided in the first embodiment of the present invention during guidewire withdrawal; Figure 5 This is a partial cross-sectional view of the neural mapping component provided in the first embodiment of the present invention; Figure 6 for Figure 5 A magnified schematic diagram of part A in the diagram. (See attached diagram.) Figures 1 to 6 As shown, the neural mapping assembly 100 provided in this embodiment includes an elastic structural member 110, an ultrasonic transducer array 120, and a first support tube 130. Both the elastic structural member 110 and the first support tube 130 are adapted to be arc-shaped, with the elastic structural member 110 disposed within the first support tube 130. The ultrasonic transducer array 120 includes a plurality of ultrasonic transducer elements 121 arranged in an arc-shaped array. The plurality of ultrasonic transducer elements 121 are spaced apart along the length direction of the elastic structural member 110 and fixed to the elastic structural member 110. The elastic structural member 110 has a through-hole extending from its proximal end to its distal end. When a guidewire 10 is inserted into the first guidewire cavity 111, the elastic structure 110, the first support tube 130, and the ultrasonic transducer array 120 can tend to be in a straight line state. The ultrasonic transducer array 120 is used to emit ultrasonic waves that can reach the nerve tissue 25 in the target area, so that the nerve tissue 25 and other tissues in the target area can reflect back the corresponding echoes. The ultrasonic transducer array 120 is also used to receive the echoes and convert them into corresponding electrical signals to generate corresponding ultrasonic images of the target area.

[0088] Therefore, the present invention captures an ultrasound image of the target area using the ultrasound transducer array 120, thereby enabling the identification of nerve tissue 25 (see [reference]) based on the captured ultrasound image of the target area. Figure 8The location of the nerve stimulation target can be obtained by measuring the location of the nerve, thus completely avoiding the uncontrollable factors caused by disordered and untargeted electrical stimulation. Simultaneously, by eliminating meaningless electrical stimulation, the physical burden on the patient can be significantly reduced, minimizing pain and risks during surgery. Furthermore, since the ultrasound transducer array 120 includes multiple ultrasound transducer elements 121 arranged in an arc-shaped array, the detection range can be expanded to detect nerves within a region, thereby forming a complete and clear ultrasound image of the target area, laying a good foundation for subsequent identification of nerve tissue 25. In addition, since the elastic structure 110 and the first support tube 130 can tend to be in a straight line under the action of the guidewire 10, the nerve mapping component 100 can be delivered to the target area in a straight line, making it easier to deliver the nerve mapping component 100 provided by this invention to its intended position.

[0089] It should be noted that, as those skilled in the art will understand, if the ultrasound image of the target area acquired by the neural mapping component 100 at a certain contact position within the target area contains neural tissue 25, then that contact position can be used as a neural stimulation target.

[0090] Specifically, the elastic structural member 110 can be made of metal or a polymer. The curvature of the elastic structural member 110 and the first support tube 130 matches the curvature of the ultrasonic transducer array 120. The elastic structural member 110 can provide a certain supporting force to maintain the curvature of the ultrasonic transducer array 120. Furthermore, the elastic structural member 110 and the first support tube 130 can be placed in a preset mold and heat-set in an oven to obtain their respective required fixed bending shapes.

[0091] Furthermore, the first support tube 130 can be made of a high-molecular polymer with good biocompatibility and electrical insulation. Even further, the elastic structural member 110 can be fixed within the first support tube 130 by welding, hot melting, adhesive bonding, or other connection methods.

[0092] It should be noted that, as those skilled in the art will understand, the number of ultrasonic transducer elements 121 included in the ultrasonic transducer array 120 can be set according to specific circumstances, and the present invention does not limit this. Preferably, the ultrasonic transducer array 120 includes a plurality of equally spaced ultrasonic transducer elements 121, thereby improving the detection effect of the ultrasonic transducer array 120.

[0093] Please continue to refer to this. Figure 7 ( Figure 7 The designation "ultrasonic transducer element 121" needs to be changed; it is a structural schematic diagram of ultrasonic transducer element 121 provided in an embodiment of the present invention. (See attached diagram.) Figure 7 As shown, the ultrasonic transducer element 121 can be a piezoelectric thin-film sensor. The piezoelectric thin-film sensor can be made of a low-impedance ferroelectric polymer material such as PVDF (piezoelectric polyvinylidene fluoride). Because ferroelectric polymer materials such as PVDF themselves vibrate at a corresponding frequency when subjected to interference from a measured energy signal (e.g., a radio frequency energy signal), they are very suitable as transmitting elements for clinical ultrasound equipment. Furthermore, due to the extremely high plasticity of ferroelectric polymer materials such as PVDF, they can be processed into various shapes suitable for the equipment (e.g., curved sheets) at a relatively low cost. Taking a radio frequency energy signal as an example, the radio frequency energy signal source 22 sends a radio frequency signal to the piezoelectric thin-film sensor (i.e., the ultrasonic transducer element 121) through one end of signal wires 23a and 23b. The other ends of the signal wires 23a and 23b are connected to the piezoelectric thin film sensor (i.e., the ultrasonic transducer element 121) through contact points 24a and 24b. Contact points 24a and 24b can be points on the metallized PVDF surface, such as a surface coated with CrAu film, and are connected to the signal wires 23a and 23b by welding.

[0094] Please continue to refer to this. Figure 8 This is an imaging schematic diagram of an ultrasonic transducer array 120 provided in an embodiment of the present invention. Figure 8 As shown, after receiving a measurement energy signal (e.g., a radio frequency energy signal), the ultrasonic transducer element 121 rapidly expands and relaxes, generating emitted ultrasonic waves 26. When these emitted ultrasonic waves 26 touch nerve tissue 25, i.e., when attempting to transmit from one substance to another irregularly shaped substance with different acoustic impedance, such as nerve tissue 25, diffuse reflection occurs. The ultrasonic waves are dispersed in all directions, and a portion of them are reflected ultrasonic waves 27 (i.e., echoes), reflected by the nerve tissue 25 and returning to strike the ultrasonic transducer element 121. At this time, the ultrasonic transducer element 121 is compressed, generating a voltage corresponding to the intensity of the reflected ultrasonic waves 27, thus completing the reception of the reflected ultrasonic waves 27 (i.e., echoes), which are then excited and acquired by the excitation acquisition module 350 described below (see below). Figure 18 ) Detection record. Nerve tissue 25 in ultrasound images (reference) Figure 9This is a schematic diagram of the acquisition of ultrasound images by the neural mapping component 100 provided in the first embodiment of the present invention. The catheter sheath 150 in the neural mapping component 100 is partially removed and is shown as a bright spot. The brightness of the bright spot reflects the intensity of the reflected ultrasound waves 27. The time interval between the ultrasonic transducer element 121 generating and transmitting ultrasound waves 26 and receiving reflected ultrasound waves 27 reflects the distance between the nerve tissue 25 and the ultrasonic transducer element 121. The distance can be calculated according to the radar ranging formula L = C * t / 2 (where L is the distance, t is the time interval, and C is the speed of sound). It should be noted that, as those skilled in the art will understand, the ultrasound waves emitted and received by a single ultrasonic transducer element 121 can only be emitted through a narrow, pencil-shaped path. The present invention, by arranging multiple ultrasonic transducer elements 121 in an arc-shaped array to form an arc-shaped ultrasonic transducer array 120, can expand the detection range, enabling the detection of nerve tissue 25 within a region and forming a complete and clear ultrasound image.

[0095] Specifically, the ultrasonic signal output by the ultrasonic transducer array 120 is reflected by the hyperechoic tissue structure, received again by the ultrasonic transducer array 120, converted into an electrical signal, and sent to the excitation acquisition module 350 described below. The acquired electrical signal is then processed by the ultrasonic image generation module 430 described below (see Figure 18 After being converted into an image signal (i.e., generating an ultrasound image), it is processed by processor 420 (see below) Figure 18 Send to monitor 320 (see) Figure 18 Output ultrasound images. Anatomically, neural structures consist of several types of tissue. Individual nerve fibers are surrounded by an endoneurium, a group of nerve fibers forms a nerve bundle, each nerve bundle is surrounded by a perineurium, and together the nerve bundles form a nerve surrounded by an epineurium. Different neural tissues25 appear differently under ultrasound. Nerve fibers themselves do not reflect any ultrasound waves (hypoechoic), so they appear black on ultrasound images. Only the endoneurium, perineurium, and the connective tissue surrounding the nerve (epidermal) reflect ultrasound waves (hypoechoic), and therefore appear bright on ultrasound images.

[0096] Please continue to refer to this. Figure 10 and Figure 11 ,in, Figure 10 This is a schematic diagram of the elastic structural member 110 in a bent state according to an embodiment of the present invention. Figure 11 This is a schematic diagram of the elastic structural member 110 in a straight state according to an embodiment of the present invention. Figure 10 and Figure 11As shown, the elastic structural member 110 has a mounting plane 112 for fixing the ultrasonic transducer array 120 on its side away from its center of curvature. The mounting plane 112 has multiple spaced baffles 113 along its length, with each baffle located between adjacent ultrasonic transducer elements 121. Therefore, by providing the mounting plane 112 for fixing the ultrasonic transducer array 120 on the elastic structural member 110, the installation of the ultrasonic transducer array 120 can be facilitated. Furthermore, by providing multiple baffles 113 on the mounting plane 112, it is not only ensured that each ultrasonic transducer element 121 in the ultrasonic transducer array 120 can be evenly arranged on the mounting plane 112, but also that there is a certain gap between adjacent ultrasonic transducers. This allows the ultrasonic transducer element 121 sufficient space to vibrate and emit ultrasonic waves after receiving a signal.

[0097] Please continue to refer to this. Figure 10 and Figure 11 ,like Figure 10 and Figure 11 As shown, the elastic structural member 110 is a hollow structure. A connecting post 114 is provided inside the elastic structural member 110 along its length, and the first guide wire cavity 111 passes through the proximal and distal ends of the connecting post 114. Therefore, by making the elastic structural member 110 a hollow structure, it is easier to heat-shape the elastic structural member 110 into the required arc shape, while also ensuring that the elastic structural member 110 tends to be straight under the action of the guide wire 10. Furthermore, by making the elastic structure hollow, a wiring channel can be provided for the wires of the ultrasonic transducer element 121. It should be noted that, as those skilled in the art will understand, through holes can be provided on the elastic structural member 110 at positions corresponding to the ultrasonic transducer element 121 for the wires of the ultrasonic transducer element 121 to pass through.

[0098] Please continue to refer to this. Figure 2 and Figure 6 ,like Figure 2 and Figure 6As shown, the neural mapping assembly 100 further includes a position sensor 140 for monitoring the position information of the neural mapping assembly 100. The position sensor 140 is fixed within the elastic structure 110, and a first lead cavity 115 for the lead wire of the ultrasound transducer element 121 to pass through and a second lead cavity 116 for the lead wire of the position sensor 140 to pass through can be formed between the position sensor 140 and the inner wall of the elastic structure 110. Thus, the position information of the neural mapping assembly 100 can be monitored in real time through the position sensor 140, providing a basis for subsequently determining the position information of the nerve stimulation target point based on the ultrasound image of the target area. Furthermore, since the wires of the ultrasonic transducer element 121 are inserted into the first wire cavity 115 and the wires of the position sensor 140 are inserted into the second wire cavity 116, the wires of the ultrasonic transducer element 121 and the position sensor 140 can be prevented from coming into contact with each other, thereby effectively avoiding the interaction between the currents in the wires of the ultrasonic transducer element 121 and the position sensor 140.

[0099] Furthermore, the position sensor 140 includes, but is not limited to, a three-dimensional magnetoelectric sensor. When the position sensor 140 is a three-dimensional magnetoelectric sensor, it can capture magnetoelectric signals and calculate the current ratio through the positioning module 600 (described below), continuously storing position information. The current ratio is then combined with the magnetic field position to generate a current-calibrated magnetic field, thereby achieving accurate measurement of the position of the neural mapping component 100. It should be noted that further details regarding the positioning principles of the three-dimensional magnetoelectric sensor can be found in materials familiar to those skilled in the art, and will not be elaborated upon here.

[0100] Please continue to refer to this. Figure 1 , Figure 2 and Figure 6 ,like Figure 1 , Figure 2 and Figure 6As shown, the first support tube 130 has an opening (not shown) on the side away from its center of curvature. The neural mapping component 100 also includes a catheter sleeve 150 covering the outside of the first support tube 130, and the ultrasonic transducer array 120 is located inside the catheter sleeve 150. Therefore, by providing an opening in the first support tube 130, it is easier to fix the elastic structural member 110 inside the first support tube 130 through the opening. Furthermore, by covering the outside of the first support tube 130 with the catheter sleeve 150, a sealed connection can be achieved, preventing direct contact between the internal components such as the ultrasonic transducer array 120 and the position sensor 140 and human blood or tissue (such as blood vessel walls), effectively preventing the internal components such as the ultrasonic transducer array 120 and the position sensor 140 from being corroded by blood, and ensuring that the ultrasonic transducer array 120 and the position sensor 140 can function normally.

[0101] Specifically, the catheter sleeve 150 can be made of a soft polymer matrix material, such as PA12 (nylon 12). By increasing the polyether segment content in the block copolymer, the catheter sleeve 150 can become more flexible, thereby enabling better adhesion to the ultrasonic transducer array 120. Furthermore, the catheter sleeve 150 can be wrapped around the outside of the first support tube 130 by hot melting or high-frequency welding.

[0102] Please continue to refer to this. Figures 1 to 6 ,like Figures 1 to 6 As shown, the neural mapping assembly 100 further includes a flexible tube 160 connected to the distal end of the first support tube 130. The flexible tube 160 has a second guidewire lumen 161 extending through both ends of its axial direction, and the second guidewire lumen 161 communicates with the first guidewire lumen 111. Therefore, by providing the flexible tube 160 at the distal end of the neural mapping assembly 100, it can be ensured that human tissues such as blood vessel walls are not damaged by the stretching and contracting movements of the neural mapping assembly 100.

[0103] Preferably, the flexible tube 160 and the first support tube 130 are integrally formed. This arrangement further enhances the overall strength of the neural mapping component 100 provided by the present invention. Furthermore, the flexible tube 160 and the conduit sheath 150 can be connected by heat fusion or high-frequency welding.

[0104] Please continue to refer to this. Figures 1 to 6 ,like Figures 1 to 6As shown, the outer diameter of the flexible tube 160 gradually decreases from its proximal end to its distal end. This design not only effectively prevents damage to human tissues such as blood vessel walls caused by the stretching and contracting movements of the neural mapping component 100, but also ensures that the segments of the neural mapping component 100 are smoothly transitioned, making it easier to reach the location where neural mapping is to be performed.

[0105] It should be noted that, although Figure 6 The description is based on the example of a solid tube with a second guide wire cavity 161 for the flexible hose 160. However, as those skilled in the art will understand, in other embodiments, the flexible hose 160 may also be a hollow structure.

[0106] Please continue to refer to this. Figures 1 to 5 as well as Figure 12 and Figure 13 ,in, Figure 12 This is a schematic diagram of the overall structure of the second support tube 170 provided in an embodiment of the present invention; Figure 13 This is a partial structural schematic diagram of the second support tube 170 provided in an embodiment of the present invention. Figures 1 to 5 as well as Figure 12 and Figure 13 As shown, the neural mapping assembly 100 further includes a second support tube 170, the distal end of which is connected to the proximal end of the first support tube 130. The second support tube 170 has a third guidewire lumen 171 extending through both ends of its axial direction, and the third guidewire lumen 171 communicates with the first guidewire lumen 111. Therefore, by providing the second support tube 170 at the proximal end of the neural mapping assembly 100, rigidity can be provided to the neural mapping assembly 100, ensuring that the neural mapping assembly 100 can be smoothly pushed into place.

[0107] Furthermore, the first support tube 130 and the second support tube 170 can be an integral structure. This arrangement effectively ensures the overall strength of the neural mapping component 100.

[0108] Please continue to refer to this. Figure 12 and Figure 13 ,like Figure 12 and Figure 13As shown, the second support tube 170 includes a coaxially arranged and hollow outer tube 172 and an inner tube 173. The inner tube 173 is inserted into the outer tube 172, and at least a portion of the inner tube 173's wall is recessed towards its axis to form a plurality of grooves 1731 extending axially. Therefore, by configuring the second support tube 170 as a double-layer structure including a coaxially arranged outer tube 172 and inner tube 173, sufficient rigidity can be ensured to further guarantee the smooth delivery of the neural mapping component 100 into place. Furthermore, by providing multiple grooves 1731 on the wall of the inner tube 173, pathways can be provided for the pull wire, the wire of the position sensor 140, and the wire of the electrode 180 (hereinafter referred to as the electrode). The inner cavity of the inner tube 173 can also provide pathways for the wire of the ultrasonic transducer element 121, the guide wire 10, etc. This effectively prevents the current in the wires of the position sensor 140, the ultrasonic transducer element 121, and the electrode 180 from interacting with each other, thereby effectively improving the stability of the neural mapping component 100 provided by the present invention during use.

[0109] Specifically, the outer tube 172 can be made of a polymer matrix material, such as Pebax (nylon elastomer) series materials. Furthermore, a reinforcing layer (such as a metal braided wire reinforcing layer) can be provided on the inner wall of the outer tube 172 to enhance the mechanical properties of the outer tube 172, thereby further ensuring the rigidity of the second support tube 170 and ensuring that the neural mapping component 100 can be smoothly pushed into place.

[0110] Furthermore, the inner tube 173 is made of PTFE (polytetrafluoroethylene). Since PTFE has a low coefficient of friction and has a self-lubricating effect, the inner tube 173 is made of PTFE, which makes it easier for the guide wire 10, the pull wire, the wire of the position sensor 140, and the wire of the ultrasonic transducer element 121 to pass through.

[0111] Furthermore, the wall thickness of the inner tube 173 is greater than 0.1 mm. This arrangement can effectively prevent the current in the wires of the position sensor 140 and the ultrasonic transducer element 121 from interacting and affecting each other.

[0112] In some exemplary embodiments, the neural mapping assembly 100 further includes an ultrasound signal control module connected to the ultrasound transducer element 121. This ultrasound signal control module is configured to control the frequency band of the ultrasound waves emitted by the ultrasound transducer element 121 and / or the time interval between ultrasound wave emissions, and to transmit the electrical signals generated by the ultrasound transducer element 121 to the ultrasound image generation module 430 (described below) for generating an ultrasound image of the target region. Thus, by indirectly establishing a communication connection between the ultrasound transducer element 121 and the ultrasound image generation module 430 (described below) through the ultrasound signal control module, the length of the wires of the ultrasound transducer element 121 can be shortened, resulting in neater and simpler wiring.

[0113] Specifically, the ultrasound signal control module is a flexible integrated circuit chip with multiple pins. The wires of each ultrasound transducer element 121 can be connected to the corresponding pins to connect with the ultrasound signal control module. The ultrasound signal control module is connected to the excitation drive module 340 (described below) via one wire and to the ultrasound image generation module 430 via another wire. Furthermore, the ultrasound signal control module is fixed inside the inner tube 173. Thus, by fixing the ultrasound signal control module inside the inner tube 173, the inner tube 173 and the outer tube 172 provide a sealed protection for the ultrasound signal control module, effectively preventing direct contact between the ultrasound signal control module and human blood or tissue (such as blood vessel walls), thereby preventing the ultrasound signal control module from being corroded by blood and ensuring that the ultrasound signal control module can function normally.

[0114] Please continue to refer to this. Figure 14 This is a schematic diagram of the overall structure of the neural mapping component 100 provided in the second embodiment of the present invention (with the conduit sheath 150 removed). Figure 14 As shown, the difference between the neural mapping component 100 provided in this embodiment and the neural mapping component 100 provided in the first embodiment is that, in this embodiment, the neural mapping component 100 further includes at least one electrode 180, which is disposed outside the first support tube 130 and avoids the ultrasonic transducer array 120. Since the neural mapping component 100 includes at least one electrode 180, the identified nerve stimulation target can be directly electrically stimulated using the neural mapping component 100 provided by this invention to further determine whether the location of the nerve stimulation target is suitable for ablation (i.e., whether the nerve stimulation target is a suitable ablation target). Thus, the determination of the nerve stimulation target and the ablation target can be completed in a single interventional operation, making the operation more convenient and saving surgical time.

[0115] Preferably, such as Figure 14 As shown, the neural mapping component 100 includes two electrodes 180. Therefore, by electrically stimulating the identified nerve stimulation target points through the two electrodes 180, the pain experienced by the patient during electrical stimulation can be reduced. Further, the electrodes 180 include, but are not limited to, ring electrodes 180. Even further, the materials of the electrodes 180 include, but are not limited to, metals such as platinum, iridium, and gold. The electrodes 180 can be fixed to the outer surface of the first support tube 130 by welding or gluing. In actual operation, stimulation energy signals (e.g., radio frequency energy signals) can be delivered to the two electrodes 180 through the energy output device 300 described below to stimulate the nerve tissue 25, and the type of nerve tissue 25 (i.e., whether the nerve tissue 25 is sympathetic or parasympathetic) can be determined by the patient's physiological response (e.g., changes in blood pressure).

[0116] Furthermore, such as Figure 14 As shown, in some embodiments, the electrode 180 is positioned closer to the distal end of the first support tube 130 than the ultrasonic transducer array 120. This arrangement effectively avoids the ultrasonic transducer array 120, preventing interaction between the two. It should be noted that, as those skilled in the art will understand, in other embodiments, the ultrasonic transducer array 120 can be divided into multiple sub-arrays along the length of the elastic structure 110, with the electrode 180 located between adjacent sub-arrays, thus avoiding the ultrasonic transducer array 120.

[0117] Please continue to refer to this. Figure 15 and Figure 16 ,in, Figure 15 A partial structural schematic diagram of the neural mapping component 100 provided in the second embodiment of the present invention; Figure 16 for Figure 15 A top view. (e.g.) Figure 15 and Figure 16 As shown, the neural mapping assembly 100 provided by the present invention further includes a fixing member 190 for fixing the pull wire. The fixing member 190 is disposed in the distal end of the first support tube 130. The distal end of the first support tube 130 is provided with a pull wire cavity 131 (for the pull wire to pass through), a fourth guide wire cavity 132 (for the guide wire 10 to pass through), and a third lead wire cavity 133 (for the lead wire of the electrode 180 to pass through). The fourth guide wire cavity 132 is connected to the first guide wire cavity 111 and the second guide wire cavity 161. Thus, by providing the fixing member 190, it is easier to fix the pull wire.

[0118] Specifically, the fixing member 190 includes, but is not limited to, a stainless steel ring, and the pull wire (made of stainless steel or nickel-titanium metal wire) can be fixed to the fixing member 190 by welding or other connection methods. Further, when there are two pull wires, the two pull wires are symmetrically arranged on the fixing member 190, spaced 180° apart, and extend through corresponding pull wire cavities 131 within the first support tube 130 to the bending control device of the handle 220 (described below). The two pull wires enable radially symmetrical bending control of the bendable section 211 of the nerve mapping catheter (described below). When the nerve mapping catheter enters the target area (e.g., the renal artery), it can efficiently enter the left and right renal arteries through bending control, eliminating the need for overall rotation of the nerve mapping catheter.

[0119] Based on the same inventive concept, this invention also provides a neural mapping catheter, please refer to... Figure 17 This is a schematic diagram of the overall structure of a neural mapping catheter provided in an embodiment of the present invention. Figure 17 As shown, the neural mapping catheter provided by the present invention includes a tube body 210 and the neural mapping component 100 described above. The distal end of the tube body 210 is connected to the proximal end of the neural mapping component 100. Since the neural mapping catheter provided by the present invention includes the neural mapping component 100, it can capture ultrasound images of the target area through the ultrasound transducer array 120. Based on the captured ultrasound images of the target area, the location of the nerve tissue 25 can be determined, thereby obtaining the location information of the nerve stimulation target point. This completely avoids the uncontrollable factors caused by disordered and untargeted electrical stimulation. Simultaneously, by eliminating meaningless electrical stimulation, the physical burden on the patient can be significantly reduced, decreasing the pain and risks they need to endure during surgery. Furthermore, since the ultrasound transducer array 120 includes multiple ultrasound transducer elements 121 arranged in an arc-shaped array, the detection range can be expanded, enabling the detection of nerves within a region. This allows for the formation of a complete and clear ultrasound image of the target area, laying a good foundation for subsequent identification of the nerve tissue 25. Furthermore, since the elastic structural member 110 and the first support tube 130 can tend to be in a straight line under the action of the guidewire 10, the neural mapping component 100 can be delivered to the target area in a straight line, thus making it easier to deliver the neural mapping component 100 into place. It should be noted that, as those skilled in the art will understand, the neural mapping catheter provided by the present invention also has other beneficial effects of the neural mapping component 100 provided by the present invention, which can be referred to in the relevant description above, and will not be repeated here.

[0120] Please continue to refer to this. Figure 17 ,like Figure 17As shown, the tube 210 includes a bendable segment 211 and a main body segment 212 connected sequentially from its distal to proximal end. The distal end of the bendable segment 211 is connected to the proximal end of the neural mapping component 100. Thus, the bending of the bendable segment 211 provides greater maneuverability for the operator, making it easier to manipulate the neural mapping component 100 located at the distal end of the neural mapping catheter to align with the inner wall of the target area.

[0121] Furthermore, such as Figure 17 As shown, the neural mapping catheter provided by the present invention also includes a handle 220 connected to the proximal end of the catheter body 210. Thus, the operator can control the bending of the bendable segment 211 using devices such as knobs, push rods, and rockers on the handle 220, providing greater operability and making it easier to achieve contact between the neural mapping component 100 located at the distal end of the neural mapping catheter and the inner wall of the target area.

[0122] Based on the same inventive concept, this invention also provides a neural mapping system, please refer to [reference needed]. Figure 18 This is a schematic diagram of the overall structure of a neural mapping system provided in an embodiment of the present invention. Figure 18 As shown, the neural mapping system provided by the present invention includes an energy output device 300, a controller 400, and the neural mapping catheter described above. The energy output device 300 and the ultrasonic transducer array 120 are both communicatively connected to the controller 400. The energy output device 300 is configured to provide mapping energy to the ultrasonic transducer array 120 so that the ultrasonic transducer array 120 can emit ultrasonic waves toward the target area. The controller 400 is configured to generate a corresponding ultrasonic image of the target area based on the electrical signal, and to obtain the location information of the neural stimulation target point based on the ultrasonic image of the target area. Since the neural mapping system provided by this invention includes the neural mapping catheter provided by this invention, the neural mapping system provides by this invention can capture ultrasound images of the target area through the ultrasound transducer array 120. Based on the captured ultrasound images of the target area, the location of the nerve tissue 25 can be determined, thereby obtaining the location information of the nerve stimulation target point. This provides a clear target for the neural stimulation program, thus completely avoiding the uncontrollable factors caused by disordered and targetless electrical stimulation, potentially increasing the therapeutic effect of RDN surgery. Simultaneously, by eliminating meaningless electrical stimulation, the physical burden on patients can be significantly reduced, decreasing the pain and risks they need to endure during surgery. It should be noted that, as those skilled in the art will understand, the neural mapping system provided by this invention also has other beneficial effects of the neural mapping catheter provided by this invention, which can be specifically referred to in the relevant descriptions above, and will not be elaborated upon here.

[0123] It should be noted that, as those skilled in the art will understand, the energy output by the energy output device 300 includes, but is not limited to, one or more of pulse energy, laser energy, ultrasonic energy, radiation energy, light energy, and radio frequency energy, and any one of these energy types can be selected as the measurement energy or the stimulation energy. It should also be noted that, as those skilled in the art will understand, the measurement energy and the stimulation energy can be the same type of energy or different types of energy, and this invention does not limit them in this regard.

[0124] In some exemplary embodiments, the controller 400 is configured to acquire location information of the neural stimulation target by means of the following steps:

[0125] The contour of neural tissue 25 is identified in the ultrasound image of the target region to determine whether neural tissue 25 exists in the ultrasound image of the target region.

[0126] If nerve tissue 25 is present in the ultrasound image of the target area, the position information of the nerve mapping component 100 at the time of acquisition of the ultrasound image of the target area is used as the position information of the nerve stimulation target.

[0127] Specifically, ultrasound technology has many advantages such as fast imaging speed, non-invasiveness, and transparency, thus meeting many requirements of neural mapping technology. However, the quality of ultrasound images is worse than other imaging technologies such as computed tomography (CT) and magnetic resonance imaging (MR), providing very limited information and being highly susceptible to noise interference. Generally, without extensive experience in ultrasound image analysis, it is difficult to accurately identify and make a judgment about neural tissue 25. Therefore, the neural mapping system provided by this invention can effectively help surgeons identify areas where neural tissue 25 may exist from the ultrasound images of the target area by automatically identifying the contours of neural tissue 25 in the acquired target area ultrasound images.

[0128] In some exemplary embodiments, the step of identifying the contour of neural tissue 25 in the ultrasound image of the target region to determine whether neural tissue 25 exists in the ultrasound image of the target region includes:

[0129] For each pixel in the ultrasound image of the target region, calculate the rate of change of brightness between that pixel and its neighboring pixels;

[0130] Based on the brightness change rate of each pixel in the ultrasound image of the target region, all candidate neural tissue contour points are identified.

[0131] Based on all the candidate neural tissue 25 contour points, determine whether neural tissue 25 exists in the ultrasound image of the target region.

[0132] For details, please refer to Figure 19 This is an ultrasound image of a target region with neural tissue 25 provided as a specific example of the present invention. Figure 19 As shown in the figure, the area indicated by the arrow is the region where nerve tissue 25 is located. As described earlier, nerve fibers themselves do not reflect any ultrasound waves, so they appear black in ultrasound images. However, the connective tissue surrounding the endoneurium, perineurium, and epineurium reflects ultrasound waves, thus appearing bright in ultrasound images. Therefore, the outline of nerve tissue 25 is located at the boundary between light and dark areas. Based on the rate of change in brightness corresponding to each pixel in the ultrasound image of the target region, all candidate nerve tissue 25 outline points can be accurately identified, thereby accurately determining whether nerve tissue 25 exists in the ultrasound image of the target region.

[0133] Further, please refer to Figure 20 This is a schematic diagram illustrating the conversion of a target region ultrasound image into a two-dimensional vector matrix, as provided in a specific example of the present invention. Figure 20 As shown, for ease of calculation, the ultrasound image of the target region can first be converted into a two-dimensional vector matrix M. The horizontal dimension m of the two-dimensional vector matrix M is determined by the number of vertical pixels (i.e., the number of height pixels) of the ultrasound image of the target region, and the vertical dimension n of the two-dimensional vector matrix M is determined by the number of horizontal pixels (i.e., the number of width pixels) of the ultrasound image of the target region. The value at each unit in the two-dimensional vector matrix M represents the grayscale value of the pixel at the corresponding position in the ultrasound image of the target region. For example, the value at i1j1 represents the grayscale value of the pixel at position i1j1 in the ultrasound image of the target region. Finally, by calculating the difference between the values ​​of each unit and its adjacent units in the two-dimensional vector matrix M, the direction (smaller grayscale value points to larger grayscale value, i.e., darker points to brighter points) and magnitude of the brightness change rate of each pixel can be obtained, which is to obtain... Figure 21 The diagram shows the vector of changes in brightness.

[0134] In some exemplary embodiments, the step of identifying all candidate neural tissue contour points based on the brightness change rate corresponding to each pixel in the ultrasound image of the target region includes:

[0135] For each pixel in the ultrasound image of the target region, determine whether the absolute value of the brightness change rate corresponding to the pixel is greater than a first preset threshold. If so, the pixel with the smaller gray value among the pixel and its neighboring pixels is selected as the candidate neural tissue contour point 25.

[0136] Specifically, such as Figure 21As shown, the brightness change rate corresponding to each pixel can be represented by a vector with an arrow of corresponding length (the length of the vector represents the absolute value of the brightness change rate, and the direction of the arrow represents the direction of the brightness change rate). The longer the length of the vector, the greater the brightness change rate between the pixel and its neighboring pixels. Thus, by taking the smaller gray value of one of the two adjacent pixels whose absolute value of the brightness change rate is greater than the first preset threshold as the candidate neural tissue 25 contour point, the contour of the neural tissue 25 can be accurately identified.

[0137] In some exemplary embodiments, determining whether neural tissue 25 exists in the ultrasound image of the target region based on all the candidate neural tissue 25 contour points includes:

[0138] If at least some of the candidate neural tissue 25 contour points can be connected in series to form a closed curve, then it is determined that neural tissue 25 exists in the ultrasound image of the target region.

[0139] Please continue to refer to this. Figure 22 This is a schematic diagram of the outline of neural tissue 25, directly identified using the brightness change rate algorithm, provided as a specific example of the present invention. For example... Figure 22 As shown, since the cross-section of the neural tissue 25 is a closed region in the ultrasound image, multiple curves can be formed by sequentially connecting the contour points of the candidate neural tissue 25 that are relatively close together (for each candidate neural tissue 25 contour point, connect it with other candidate neural tissue 25 contour points whose distance to it is less than or equal to a second preset threshold). If at least some of the candidate neural tissue 25 contour points in the ultrasound image of the target region can be connected to form a closed curve, it can be determined that neural tissue 25 exists in the ultrasound image of the target region. That is, it can be determined that neural tissue 25 is present at the acquisition position corresponding to the ultrasound image of the target region, and the acquisition position corresponding to the ultrasound image of the target region can be used as a nerve stimulation target point. It should be noted that, as those skilled in the art will understand, the closed curve formed by connecting the contour points of the candidate neural tissue 25 is the contour of the neural tissue 25, that is, the area defined by the closed curve is the area where the neural tissue 25 is located.

[0140] In some exemplary embodiments, the controller 400 is also configured to perform the following operations prior to recognizing the contours of neural tissue 25 in the ultrasound image of the target region:

[0141] The ultrasound image of the target region is denoised to obtain a denoised ultrasound image of the target region.

[0142] Correspondingly, the identification of the neural tissue 25 contour in the ultrasound image of the target region specifically involves:

[0143] The contours of neural tissue 25 are identified in the denoised ultrasound image of the target region.

[0144] While directly using the brightness change rate algorithm mentioned above can help surgeons effectively identify the contours of nerve tissue25, the low echogenicity of nerve fibers and the high echogenicity of the perineurium and epineurium make this method of identifying nerve location susceptible to interference from the complex structures of high-echoic tissues. For example... Figure 22 As shown, although the brightness change rate at the location of nerve tissue 25 is significant, the complex structure of the epineurium causes the originally complete nerve cross-sectional contour to be identified as multiple complex shapes. Furthermore, the echo signals reflected by other connective tissues surrounding the renal artery also interfere with the recognition result of the nerve tissue 25 contour. Therefore, by first denoising the ultrasound image of the target region and then recognizing the nerve tissue 25 contour in the denoised ultrasound image, the recognition result of the nerve tissue 25 contour can be avoided from being interfered with by noise and complex nerve structures. It should be noted that, as those skilled in the art will understand, the brightness change rate algorithm described above can be used to recognize the nerve tissue 25 contour in the denoised ultrasound image of the target region; specific details can be found in the relevant description above, and will not be repeated here.

[0145] In some exemplary embodiments, the denoising process is performed on the ultrasound image of the target region:

[0146] The ultrasound image of the target region is uniformly divided into multiple intervals of the same size;

[0147] For each interval, the average gray value of all pixels in the interval is taken as the gray value of all pixels in the interval to obtain the corresponding neural probability distribution map.

[0148] The neural probability distribution map is smoothed to obtain a denoised ultrasound image of the target region.

[0149] For details, please refer to Figures 23a to 23c ,in, Figure 23a for Figure 19 The diagram shows the probability distribution of nerves corresponding to the ultrasound image of the target area. Figure 23b for Figure 23a The ultrasound image of the target region obtained after smoothing the neural probability distribution map shown is a denoised image. Figure 23c for Figure 23b A schematic diagram of the neural tissue contour recognition results. (See diagram for example.) Figures 23a to 23cAs shown, by dividing the ultrasound image of the target region into several equally sized intervals (each interval contains the same number of pixels), the average gray value of all pixels in each interval can represent the probability of the presence of neural tissue 25 within that interval. The higher the average value (i.e., the larger the gray value), the higher the probability of the presence of neural tissue 25 in that interval. Thus, by obtaining a neural probability distribution map, the influence of overly complex epineurium structures on the contour recognition results of neural tissue 25 can be effectively avoided. Since the above method inevitably leads to a significant loss of detail, causing some nerve bundles (e.g., 1μm to 100μm) to be ignored, when dividing the ultrasound image of the target region, it is necessary to ensure that the size of the divided intervals does not exceed the diameter of most nerve bundles (approximately 50μm) to prevent important nerve bundles from being ignored as much as possible.

[0150] Furthermore, smoothing algorithms for smoothing neural probability distribution maps include, but are not limited to, Jacobi iteration, Gauss-Seidel iteration, or successive over-relaxation.

[0151] Specifically, the iteration can be performed according to the following formula:

[0152]

[0153] in, This represents the grayscale value in the (x, y) interval during the (n+1)th iteration. This represents the grayscale value in the interval (x+1, y) during the nth iteration (i.e., the previous iteration). This represents the grayscale value in the interval (x-1, y) during the nth iteration (i.e., the previous iteration). This represents the grayscale value in the interval (x, y+1) during the nth iteration (i.e., the previous iteration). This represents the grayscale value of the (x, y-1) interval in the nth iteration (i.e., the previous iteration). It should be noted that, as those skilled in the art will understand, the four intervals (x+1, y), (x-1, y), (x, y+1), and (x, y-1) are the four intervals adjacent to the (x, y) interval.

[0154] It should be noted that, as those skilled in the art will understand, the total number of iterations can be set according to specific circumstances, and this invention does not limit this. Different smoothing algorithms have different attenuation effects on different grayscale distributions, and the smoothing algorithm has a stronger attenuation effect on high-probability intervals of non-circular distributions (i.e., intervals with high grayscale values), thus effectively avoiding interference from echo signals reflected by other connective tissues such as the renal artery wall on subsequent analysis. It should also be noted that, as those skilled in the art will understand, inevitably, the contour of neural tissue 25 will tend to be more circular (smoother) after each iteration, thus losing a large amount of contour details, but this will not affect the recognition effect of neural tissue 25 alone.

[0155] In some exemplary embodiments, the controller 400 is also configured to perform the following steps:

[0156] The operator is reminded to mark the nerve stimulation target on the three-dimensional model of the target area, and / or to control the nerve mapping catheter to perform electrical stimulation on the location of the nerve stimulation target, and to determine whether the location of the nerve stimulation target meets the ablation requirements based on the results of the electrical stimulation.

[0157] Specifically, when the controller 400 calculates the location information of nerve bundles and / or densely packed nerve regions (i.e., the location information of nerve stimulation target points), it maps this information to the ultrasound image of the target area and provides reminders to the surgeon through graphics and / or annotations. The surgeon can then mark the nerve stimulation target points at the corresponding locations on the three-dimensional model of the target area based on the prompted information. It should be noted that, as those skilled in the art will understand, the specific details regarding how to determine whether the location of the nerve stimulation target points meets the ablation requirements based on the results of electrical stimulation can be found in relevant techniques known to those skilled in the art, and therefore will not be elaborated upon here.

[0158] Please continue to refer to this. Figure 18 ,like Figure 18 As shown, the controller 400 can be integrated with the energy output device 300, that is, the controller 400 can be located inside the energy output device 300. The energy output device 300 includes external components such as a foot switch 310, a display 320, and a touch screen 330, as well as internal components such as an excitation drive module 340 and an excitation acquisition module 350. Further, as... Figure 18 As shown, the controller 400 includes a data processing module 410, a processor 420, and an ultrasound image generation module 430. It should be noted that, as those skilled in the art will understand, the display 320 and the touchscreen 330 may be the same component.

[0159] Furthermore, such as Figure 18As shown, the neural mapping system provided by the present invention also includes a three-dimensional mapping device 500 and a positioning module 600 connected in communication. The three-dimensional mapping device 500 includes a three-dimensional display 510, and both the three-dimensional mapping device 500 and the positioning module 600 are connected in communication with the controller 400.

[0160] The following example uses the renal artery as the target region, and combines it with... Figure 24 The present invention provides a detailed description of the specific workflow of the neural mapping system provided by the present invention, wherein... Figure 24 This is a flowchart of a neural mapping system provided in an embodiment of the present invention.

[0161] like Figure 24 As shown, during the procedure, the neuromapping catheter (including the catheter body 210 and the neuromapping component 100) is inserted into the patient's renal artery lumen via femoral artery puncture by the surgeon. The surgeon can control the neuromapping component 100 to move freely along the arterial lumen within the patient's body by operating the handle 220. Furthermore, the surgeon can control the bending of the bendable segment 211 by using knobs, push rods, rockers, etc. on the handle 220, providing the surgeon with more operability and making it easier to achieve the contact between the neuromapping component 100 and the inner wall of the renal artery.

[0162] Once the distal end of the neuromapping catheter (i.e., the neuromapping component 100) enters the renal artery (generally requiring angiography for confirmation), the operator or their assistant can use the 3D mapping device 500 to begin building a 3D model of the target region (renal artery 3D model). The establishment of the 3D model of the target region is primarily achieved through the collaboration of the position sensor 140 built into the neuromapping component 100 of the neuromapping catheter and the positioning module 600 connected to the 3D mapping device 500. The movement of the position sensor 140 within the patient's body, driven by the neuromapping catheter, is sensed by the positioning module 600. The 3D mapping device 500 records the trajectory of the neuromapping catheter in space to generate the 3D model of the target region. The resulting target region model is then presented to the operator as an image via a 3D display 510.

[0163] After obtaining the three-dimensional model of the target area, the surgeon can control the neural mapping catheter to ensure that the distal neural mapping component 100 is in close contact with the renal artery wall. At this time, after receiving the mapping command sent by the surgeon via the touch screen 330 or foot switch 310, the processor 420 controls the excitation drive module 340 to emit ultrasound signals radially towards the renal artery lumen via the tail wire 360, the tube body 210, and then the ultrasound transducer array 120 in the neural mapping component 100. When the ultrasound signal comes into contact with hyperechoic tissues (such as the perineum, epineurium, etc.), it will be reflected, and the reflected wave will be captured again by the excitation acquisition module 350 and converted into image data by the ultrasound image generation module 430 and fed back to the processor 420. Then, the processor 420 sends the captured ultrasound image of the target area to the data processing module 410. After receiving the ultrasound image data of the target area, the data processing module 410 performs denoising processing on the ultrasound image of the target area, and then identifies the contour of the nerve tissue 25 in the denoised ultrasound image of the target area to calculate the location of the nerve bundles and / or densely packed nerve regions (i.e., calculate the location of the nerve tissue 25). Finally, it evaluates the calculated location of the nerve bundles and / or densely packed nerve regions and provides subsequent operation suggestions (such as whether to stimulate the current location (i.e., the current attachment position of the nerve mapping component 100), the stimulation parameters, etc.) and feeds them back to the processor 420. The above program can be simply understood as a function to assist the surgeon in analyzing and interpreting ultrasound images. This system can not only be used to assist in analyzing the patient's renal artery ultrasound images, but also to assist in analyzing the optimal stimulation parameters based on the calculated location of the nerve bundles and / or densely packed nerve regions.

[0164] On the other hand, after the ultrasound image generation module 430 obtains the ultrasound image of the target area and feeds it back to the processor 420, the processor 420 also sends the image information to the display 320 to provide the surgeon with the real-time ultrasound image of the target area. Simultaneously, when the processor 420 obtains the location information of the nerve bundles and / or densely packed nerve regions calculated by the data processing module 410, it maps this location information onto the ultrasound image of the target area displayed on the display 320, providing feedback and suggestions to the surgeon through graphics and / or annotations. Finally, the surgeon can make corresponding annotations at the corresponding positions of the three-dimensional model of the target area displayed on the three-dimensional mapping device 500 based on the prompted information. The annotated positions will serve as target points for subsequent nerve stimulation (i.e., the annotated positions will serve as nerve stimulation target points), providing a clear target for the nerve stimulation program.

[0165] It should be noted that, as those skilled in the art will understand, when the neural mapping conduit includes electrode 180, it can be used as follows: Figure 24As shown, if it is determined that nerve tissue 25 is present in the ultrasound image of the target area acquired at the current attachment position, an electrical stimulation signal (e.g., an electrical pulse signal) can be directly applied to the electrode 180 at the current attachment position for electrical stimulation. If the electrical stimulation result indicates that the current attachment position meets the ablation requirements, ablation can be performed directly at the current attachment position. Alternatively, after determining all nerve stimulation target points, the optimal nerve stimulation path can be calculated based on the location information of all nerve stimulation target points, and electrical stimulation can be performed at each nerve stimulation target point according to the nerve stimulation path. If the electrical stimulation result indicates that the current nerve stimulation target point meets the ablation requirements, ablation can be performed directly at the current nerve stimulation target point. When the nerve mapping catheter does not include the electrode 180, after determining all nerve stimulation target points, the optimal nerve stimulation path can be calculated based on the location information of all nerve stimulation target points, and electrical stimulation can be performed at each nerve stimulation target point according to the nerve stimulation path. If the electrical stimulation result indicates that the current nerve stimulation target point meets the ablation requirements, ablation can be performed directly at the current nerve stimulation target point. Furthermore, such as Figure 24 As shown, the entire process can be terminated when the number of ablation points is greater than or equal to the preset number (e.g., 4).

[0166] It should be noted that the above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the protection scope of the present invention. Obviously, those skilled in the art can make various modifications and variations to the invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations fall within the scope of the present invention and its equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A nerve mapping assembly comprising: The elastic structure, the ultrasonic transducer array and the first support tube are adapted to be arranged in an arc shape, and the elastic structure is arranged in the first support tube; The ultrasonic transducer array comprises a plurality of ultrasonic transducer elements arranged in an arc array, and the plurality of ultrasonic transducer elements are arranged at intervals along the length direction of the elastic structure and fixed on the elastic structure; The elastic structure has a first guide wire cavity penetrating through the proximal end and the distal end thereof, and when a guide wire is inserted into the first guide wire cavity, the elastic structure, the first support tube and the ultrasonic transducer array can tend to be in a straight line state; The ultrasonic transducer array is used for emitting ultrasonic waves capable of reaching nerve tissue in a target region to the target region, so that the nerve tissue and other tissues in the target region can reflect corresponding echoes, and the ultrasonic transducer array is also used for receiving the echoes and converting them into corresponding electrical signals for generating a corresponding target region ultrasonic image; One side of the elastic structure away from the center of curvature thereof is provided with a mounting plane for fixing the ultrasonic transducer array, and the mounting plane is provided with a plurality of baffles arranged at intervals along the length direction thereof, and the baffles are located between adjacent two ultrasonic transducer elements. The elastic structure and the first support tube have an arc matched with the arc of the ultrasonic transducer array, and the elastic structure can provide a certain support force for maintaining the arc of the ultrasonic transducer array.

2. The nerve mapping assembly of claim 1, wherein, The elastic structure is a hollow structure, and the inside of the elastic structure is provided with a connecting column along the length direction thereof, and the first guide wire cavity penetrates through the proximal end and the distal end of the connecting column.

3. The nerve mapping assembly of claim 1, wherein, The nerve mapping assembly further comprises a position sensor for monitoring position information of the nerve mapping assembly, the position sensor is fixed in the elastic structure, and a first wire cavity for the wires of the ultrasonic transducer elements to pass through and a second wire cavity for the wire of the position sensor to pass through can be formed between the position sensor and the inner wall of the elastic structure.

4. The nerve mapping assembly of claim 1, wherein, One side of the first support tube away from the center of curvature thereof is provided with an opening, and the nerve mapping assembly further comprises a catheter sleeve layer wrapped outside the first support tube, and the ultrasonic transducer array is located in the catheter sleeve layer.

5. The nerve mapping assembly of claim 1, wherein, The nerve mapping assembly further comprises a flexible hose connected to the distal end of the first support tube, and the flexible hose has a second guide wire cavity penetrating through the axial two ends thereof, and the second guide wire cavity is in communication with the first guide wire cavity.

6. The nerve mapping assembly of claim 1, wherein, The nerve mapping assembly further comprises a second support tube, and the distal end of the second support tube is connected to the proximal end of the first support tube, and the second support tube has a third guide wire cavity penetrating through the axial two ends thereof, and the third guide wire cavity is in communication with the first guide wire cavity.

7. The nerve mapping assembly of claim 6, wherein, The second support tube comprises a coaxially arranged and hollow outer tube and an inner tube, the inner tube is inserted into the outer tube, and at least part of the tube wall of the inner tube is recessed toward the position of the axis to form a plurality of grooves arranged along the axial direction.

8. The nerve mapping assembly of claim 1, wherein, The nerve mapping assembly further comprises at least one electrode disposed outside the first support tube, and the electrode is arranged away from the ultrasonic transducer array.

9. A nerve mapping catheter, comprising: The nerve mapping assembly of any one of claims 1-8, wherein the catheter comprises a tube body connected to a proximal end of the nerve mapping assembly.

10. The nerve mapping catheter of claim 9, wherein, The tube body comprises a bendable segment and a main body segment connected in sequence along a direction from a distal end to a proximal end of the tube body, and a distal end of the bendable segment is connected to the proximal end of the nerve mapping assembly.

11. A neural mapping system, characterized by, The nerve mapping catheter of any one of claims 9-10, wherein the energy output device and the ultrasonic transducer array are both in communication with the controller, the energy output device is configured to provide mapping energy to the ultrasonic transducer array so that the ultrasonic transducer array can emit ultrasonic waves to the target region, and the controller is configured to generate a corresponding target region ultrasonic image according to the electrical signal and obtain position information of a nerve stimulation target point according to the target region ultrasonic image.

12. The nerve mapping system of claim 11, wherein, The controller is configured to obtain the position information of the nerve stimulation target point by the following steps: identifying a nerve tissue contour of the target region ultrasonic image to determine whether there is nerve tissue in the target region ultrasonic image; and if there is nerve tissue in the target region ultrasonic image, taking position information of the nerve mapping assembly when the target region ultrasonic image is collected as the position information of the nerve stimulation target point.

13. The nerve mapping system of claim 12, wherein, The identifying a nerve tissue contour of the target region ultrasonic image to determine whether there is nerve tissue in the target region ultrasonic image comprises: calculating a brightness change rate of each pixel point in the target region ultrasonic image and a pixel point adjacent to the pixel point; finding all candidate nerve tissue contour points according to the brightness change rate corresponding to each pixel point in the target region ultrasonic image; and determining whether there is nerve tissue in the target region ultrasonic image according to all the candidate nerve tissue contour points.

14. The nerve mapping system of claim 13, wherein, The finding all candidate nerve tissue contour points according to the brightness change rate corresponding to each pixel point in the target region ultrasonic image comprises: for each pixel point in the target region ultrasonic image, determining whether an absolute value of the brightness change rate corresponding to the pixel point is greater than a first preset threshold value, and if so, taking a gray value of a smaller one of the pixel point and a pixel point adjacent to the pixel point as a candidate nerve tissue contour point.

15. The nerve mapping system of claim 13, wherein, The determining whether there is nerve tissue in the target region ultrasonic image according to all the candidate nerve tissue contour points comprises: if at least part of the candidate nerve tissue contour points can be connected in series to form a closed curve, it is determined that there is nerve tissue in the target region ultrasonic image.

16. The nerve mapping system of claim 13, wherein, The controller is further configured to perform the following operation before identifying a nerve tissue contour of the target region ultrasonic image: performing denoising processing on the target region ultrasonic image to obtain a denoised target region ultrasonic image.

17. The nerve mapping system of claim 16, wherein, The denoising processing on the target region ultrasonic image comprises: The target region ultrasound image is evenly divided into a plurality of intervals with the same size; For each interval, an average value of the gray values of all pixel points in the interval is taken as the gray value of all pixel points in the interval to obtain a corresponding nerve probability distribution map; The nerve probability distribution map is smoothed to obtain a denoised target region ultrasound image.

18. The nerve mapping system of claim 11, wherein, The controller is further configured to perform the following steps: The operator is prompted to mark a nerve stimulation target on the target region three-dimensional model, and / or the nerve mapping catheter is controlled to perform electrical stimulation on a position where the nerve stimulation target is located, and whether the position where the nerve stimulation target is located meets the ablation requirement is determined according to a result of the electrical stimulation.

19. The nerve mapping system of claim 11, wherein, The energy output device comprises an excitation driving module, an excitation collecting module and external components, wherein the external components comprise at least one of a foot switch, a display and a touch screen.

20. The nerve mapping system of claim 11, wherein, The nerve mapping system further comprises a three-dimensional mapping device and a positioning module which are communicatively connected, the three-dimensional mapping device comprises a three-dimensional display, and the three-dimensional mapping device and the positioning module are both communicatively connected with the controller.

21. The nerve mapping system of claim 11, wherein, The controller comprises a data processing module, a processor and an ultrasound image generation module, and the data processing module and the ultrasound image generation module are both communicatively connected with the processor.

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